ZINPLAVA is a monoclonal antibody indicated to reduce recurrence of Clostridium difficile infection in patients receiving antibacterial treatment who are at high risk of recurrence. It binds to and neutralizes C. difficile toxin B. The recommended dosage is a single 10 mg/kg intravenous infusion over 60 minutes. Common adverse reactions include nausea, pyrexia, and headache. Heart failure occurred more often in patients with a history of congestive heart failure treated with ZINPLAVA.
Ficha técnica de la vacuna AstraZeneca contra el covid-1920minutos
The document provides information on the COVID-19 Vaccine AstraZeneca, including its composition, dosage, administration method, safety profile, and potential adverse reactions. The key points are:
- It is a suspension for injection containing a chimpanzee adenovirus vector encoding the SARS-CoV-2 spike glycoprotein.
- The vaccination course consists of two separate intramuscular doses administered 4 to 12 weeks apart.
- Common adverse reactions reported in clinical trials included injection site tenderness, headache, fatigue, myalgia, and pyrexia. Most were mild to moderate and resolved within a few days.
Gazyva is a medicine that works with the body’s own immune system to attack blood cells called B-cells that have a certain marker on their surface (CD20). B-cells are the cause of common blood cancers.1,2
Gazyva is FDA-approved for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil chemotherapy.3
Phase III clinical data showed that Gazyva plus chlorambucil chemotherapy helped people with CLL live longer without the disease worsening than chlorambucil chemotherapy alone.3
Vasopressin 20 international units ml solution for injection smpc taj pharma...Taj Pharma
This document summarizes information about Vasopressin 20 International Units/ml Solution for Injection produced by Taj Pharmaceuticals. It describes the drug's approved therapeutic uses for diabetes insipidus and bleeding esophageal varices. It provides dosing and administration instructions, lists contraindications and warnings regarding its use in certain patient populations, and identifies potential adverse effects such as water intoxication, hypertension, and peripheral ischemia. The document also outlines pharmaceutical aspects including composition, storage requirements, and manufacturer information.
EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Aerpio TherapeuticsHealthegy
Presentation by Aerpio Therapeutics at OIS@ASRS 2016.
Participant:
Joseph Gardner, President & CEO - Aerpio Therapeutics
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Indocap capsules contain the active ingredient indomethacin, which is a nonsteroidal anti-inflammatory drug used to treat conditions such as arthritis, bursitis, tendonitis, and gout. It works by blocking inflammation-causing substances. Indocap comes in 25mg and 75mg capsules and is prescribed to reduce pain, swelling, stiffness and joint pain associated with these conditions. Common side effects include headache, dizziness and nausea. Indocap should be used with caution during pregnancy, especially in the third trimester, and is contraindicated for people with certain conditions like asthma or heart failure.
The document describes the design and results of the ASCEND-HF trial, which evaluated the clinical effectiveness and safety of nesiritide compared to placebo for treatment of acute decompensated heart failure. The trial found no significant difference between nesiritide and placebo for the co-primary endpoints of 30-day mortality or heart failure rehospitalization. Nesiritide was associated with greater improvement in dyspnea at 6 and 24 hours compared to placebo.
Chlordiazepoxide 10mg capsules smpc taj pharmaceuticalsTaj Pharma
Chlordiazepoxide Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Chlordiazepoxide Dosage & Rx Info | Chlordiazepoxide Uses, Side Effects -: Indications, Side Effects, Warnings, Chlordiazepoxide - Drug Information - Taj Pharma, Chlordiazepoxide dose Taj pharmaceuticals Chlordiazepoxide interactions, Taj Pharmaceutical Chlordiazepoxide contraindications, Chlordiazepoxide price, Chlordiazepoxide Taj Pharma Chlordiazepoxide 10mg Capsules SMPC- Taj Pharma . Stay connected to all updated on Chlordiazepoxide Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
This document provides information on Levofloxacin Injection 5mg/ml Taj Pharma, including its uses, dosage, administration method, contraindications, and warnings. Specifically, it is indicated for the treatment of community-acquired pneumonia, complicated skin and soft tissue infections, pyelonephritis, complicated urinary tract infections, chronic bacterial prostatitis, and inhalation anthrax. It should be administered by slow intravenous infusion once or twice daily. Special warnings include tendinitis and tendon rupture, Clostridium difficile associated disease, and QT interval prolongation.
Ficha técnica de la vacuna AstraZeneca contra el covid-1920minutos
The document provides information on the COVID-19 Vaccine AstraZeneca, including its composition, dosage, administration method, safety profile, and potential adverse reactions. The key points are:
- It is a suspension for injection containing a chimpanzee adenovirus vector encoding the SARS-CoV-2 spike glycoprotein.
- The vaccination course consists of two separate intramuscular doses administered 4 to 12 weeks apart.
- Common adverse reactions reported in clinical trials included injection site tenderness, headache, fatigue, myalgia, and pyrexia. Most were mild to moderate and resolved within a few days.
Gazyva is a medicine that works with the body’s own immune system to attack blood cells called B-cells that have a certain marker on their surface (CD20). B-cells are the cause of common blood cancers.1,2
Gazyva is FDA-approved for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil chemotherapy.3
Phase III clinical data showed that Gazyva plus chlorambucil chemotherapy helped people with CLL live longer without the disease worsening than chlorambucil chemotherapy alone.3
Vasopressin 20 international units ml solution for injection smpc taj pharma...Taj Pharma
This document summarizes information about Vasopressin 20 International Units/ml Solution for Injection produced by Taj Pharmaceuticals. It describes the drug's approved therapeutic uses for diabetes insipidus and bleeding esophageal varices. It provides dosing and administration instructions, lists contraindications and warnings regarding its use in certain patient populations, and identifies potential adverse effects such as water intoxication, hypertension, and peripheral ischemia. The document also outlines pharmaceutical aspects including composition, storage requirements, and manufacturer information.
EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Aerpio TherapeuticsHealthegy
Presentation by Aerpio Therapeutics at OIS@ASRS 2016.
Participant:
Joseph Gardner, President & CEO - Aerpio Therapeutics
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Indocap capsules contain the active ingredient indomethacin, which is a nonsteroidal anti-inflammatory drug used to treat conditions such as arthritis, bursitis, tendonitis, and gout. It works by blocking inflammation-causing substances. Indocap comes in 25mg and 75mg capsules and is prescribed to reduce pain, swelling, stiffness and joint pain associated with these conditions. Common side effects include headache, dizziness and nausea. Indocap should be used with caution during pregnancy, especially in the third trimester, and is contraindicated for people with certain conditions like asthma or heart failure.
The document describes the design and results of the ASCEND-HF trial, which evaluated the clinical effectiveness and safety of nesiritide compared to placebo for treatment of acute decompensated heart failure. The trial found no significant difference between nesiritide and placebo for the co-primary endpoints of 30-day mortality or heart failure rehospitalization. Nesiritide was associated with greater improvement in dyspnea at 6 and 24 hours compared to placebo.
Chlordiazepoxide 10mg capsules smpc taj pharmaceuticalsTaj Pharma
Chlordiazepoxide Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Chlordiazepoxide Dosage & Rx Info | Chlordiazepoxide Uses, Side Effects -: Indications, Side Effects, Warnings, Chlordiazepoxide - Drug Information - Taj Pharma, Chlordiazepoxide dose Taj pharmaceuticals Chlordiazepoxide interactions, Taj Pharmaceutical Chlordiazepoxide contraindications, Chlordiazepoxide price, Chlordiazepoxide Taj Pharma Chlordiazepoxide 10mg Capsules SMPC- Taj Pharma . Stay connected to all updated on Chlordiazepoxide Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
This document provides information on Levofloxacin Injection 5mg/ml Taj Pharma, including its uses, dosage, administration method, contraindications, and warnings. Specifically, it is indicated for the treatment of community-acquired pneumonia, complicated skin and soft tissue infections, pyelonephritis, complicated urinary tract infections, chronic bacterial prostatitis, and inhalation anthrax. It should be administered by slow intravenous infusion once or twice daily. Special warnings include tendinitis and tendon rupture, Clostridium difficile associated disease, and QT interval prolongation.
The document summarizes several drug approvals and updates from the FDA in August 2017. Mavyret was approved for treating HCV genotypes 1-6 without cirrhosis or with compensated cirrhosis. Carospir received approval as an oral suspension for heart failure, hypertension, and hepatic edema. Duzallo was approved as a combination of lesinurad and allopurinol for treating gout in patients not at target uric acid levels on allopurinol alone. Vabomere was approved for complicated UTIs caused by designated bacteria. Other notable approvals included Idhifa for AML, Besponsa for ALL, and Benznidazole for Chagas disease in pediatric patients.
Cinnarizine 15 mg tablets smpc taj pharmaceuticalsTaj Pharma
Cinnarizine Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Cinnarizine Dosage & Rx Info | Cinnarizine Uses, Side Effects -: Indications, Side Effects, Warnings, Cinnarizine - Drug Information - Taj Pharma, Cinnarizine dose Taj pharmaceuticals Cinnarizine interactions, Taj Pharmaceutical Cinnarizine contraindications, Cinnarizine price, Cinnarizine Taj Pharma Cinnarizine 15 mg Tablets SMPC- Taj Pharma . Stay connected to all updated on Cinnarizine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Drug Monograph and Literature Review: "Arcapta Neohaler"Joy Awoniyi
This document provides a drug monograph and literature review for Arcapta Neohaler, which contains indacaterol maleate. It is approved for the treatment of chronic obstructive pulmonary disease (COPD) as a once-daily long-acting beta agonist. The monograph details the drug's indications, dosage forms, mechanism of action, pharmacokinetics, contraindications, warnings, adverse effects, drug interactions, and dosing. It concludes with a review of the literature on indacaterol maleate and COPD treatment.
Levosimendan for Injection Taj Pharma SmPCTajPharmaQC
Levosimendan for Injection 12.5mg, 25mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Levosimendan Dosage & Rx Info | Levosimendan Uses, Side Effects Levosimendan: Indications, Side Effects, Warnings, Levosimendan -Drug Information –Taj Pharma, Levosimendan dose Taj pharmaceuticals Levosimendan interactions, Taj Pharmaceutical Levosimendan contraindications, Levosimendan price, Levosimendan Taj Pharma Levosimendan SmPC-Taj Pharma Stay connected to all updated on Levosimendan Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
The document summarizes several new drug approvals and formulations by the FDA in October and November 2017. Key approvals included:
- Abilify Mycite (aripiprazole tablets with sensor), approved to track drug ingestion in real-time.
- Fasenra (benralizumab), approved for add-on maintenance treatment of severe asthma.
- Prevymis (letermovir), approved to prevent cytomegalovirus infection in transplant recipients.
- Vyzulta (latanoprostene bunod), approved to reduce eye pressure in glaucoma as an alternative to latanoprost.
- Juluca (dolutegra
Bivalirudin for Injection Taj Pharma SmPCTajPharmaQC
Bivalirudin for Injection 250mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Bivalirudin Dosage & Rx Info | Bivalirudin Uses, Side Effects Bivalirudin: Indications, Side Effects, Warnings, Bivalirudin -Drug Information –Taj Pharma, Bivalirudin dose Taj pharmaceuticals Bivalirudin interactions, Taj Pharmaceutical Bivalirudin contraindications, Bivalirudin price, Bivalirudin Taj Pharma Bivalirudin SmPC-Taj Pharma Stay connected to all updated on Bivalirudin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Telaprevir is a protease inhibitor approved to treat genotype 1 chronic hepatitis C in
combination with peginterferon and ribavirin. It works by inhibiting the HCV NS3/4A protease
to prevent viral replication. Several clinical trials found telaprevir combination therapy resulted
in higher rates of undetectable HCV RNA levels and sustained virologic response compared to
peginterferon-ribavirin alone. The most common side effects were rash, pruritis, fatigue, and
gastrointestinal issues. Though telaprevir is associated with more side effects, its ability to
shorten treatment duration and improve outcomes outweighs the increased costs. As such, the
Risperidone 2mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
Risperidone Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Risperidone Dosage & Rx Info | Risperidone Uses, Side Effects -: Indications, Side Effects, Warnings, Risperidone - Drug Information - Taj Pharma, Risperidone dose Taj pharmaceuticals Risperidone interactions, Taj Pharmaceutical Risperidone contraindications, Risperidone price, Risperidone Taj Pharma Risperidone 2mg Film Coated TabletsSMPC- Taj Pharma . Stay connected to all updated on Risperidone Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Nifedipine 30 mg prolonged release tablets smpc taj pharmaceuticalsTaj Pharma
Nifedipine Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Nifedipine Dosage & Rx Info | Nifedipine Uses, Side Effects -: Indications, Side Effects, Warnings, Nifedipine - Drug Information - Taj Pharma, Nifedipine dose Taj pharmaceuticals Nifedipine interactions, Taj Pharmaceutical Nifedipine contraindications, Nifedipine price, Nifedipine Taj Pharma Nifedipine 30mg Prolong Release Tablets SMPC- Taj Pharma . Stay connected to all updated on Nifedipine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Syndros is an oral solution containing dronabinol, a synthetic cannabinoid. It is approved for the treatment of anorexia associated with weight loss in AIDS patients and nausea and vomiting caused by cancer chemotherapy. Syndros works by targeting cannabinoid receptors in the brain to control nausea, vomiting, and appetite. It comes with warnings about potential neurological and hemodynamic side effects and drug interactions. The recommended dosing regimens depend on the condition being treated.
Forzest (Generic Tadalafil Tablets) belongs to a class of medicines called phosphodiesterase-5 (PDE5) inhibitors, is an oral medicine that is used for treating impotence (the inability to attain or maintain a penile erection) and benign prostatic hyperplasia (BPH). The same medicine treats pulmonary arterial hypertension and improves exercise capacity in men and women. Forzest tablets have a very long 17.5 hours half-life as compared with only 4 hours for Sildenafil Citrate.
Simeprevir (Olysio) is a hepatitis C virus (HCV) NS3/4A protease inhibitor approved to treat chronic HCV genotype 1 infection. It is intended for use in combination with peginterferon alfa and ribavirin. The standard treatment duration is 12 weeks of simeprevir along with peginterferon alfa and ribavirin, followed by either 12 or 36 additional weeks of peginterferon alfa and ribavirin depending on prior response. Common side effects during the first 12 weeks of treatment include rash, pruritus, and nausea. Use of simeprevir requires consideration of potential drug interactions and it should not be used as mon
Risperidone Dispersible Tablets Taj Pharma SmPCTajPharmaQC
Risperidone Dispersible Tablets 1mg, 2mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Risperidone Dosage & Rx Info | Risperidone Uses, Side Effects Risperidone: Indications, Side Effects, Warnings, Risperidone-Drug Information –Taj Pharma, Risperidone dose Taj pharmaceuticals Risperidone interactions, Taj Pharmaceutical Risperidone contraindications, Risperidone price, Risperidone Taj Pharma Risperidone SmPC-Taj Pharma Stay connected to all updated on Risperidone Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Telbivudine Tablet 600mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Telbivudine Dosage & Rx Info | Telbivudine Uses, Side Effects Telbivudine: Indications, Side Effects, Warnings, Telbivudine -Drug Information –Taj Pharma, Telbivudine dose Taj pharmaceuticals Telbivudine interactions, Taj Pharmaceutical Telbivudine contraindications, Telbivudine price, Telbivudine Taj Pharma Telbivudine SmPC-Taj Pharma Stay connected to all updated on Telbivudine Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Tigecycline 50 mg powder for solution for infusion smpc taj pharmaceuticalsTaj Pharma
TIGECYCLINE Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, TIGECYCLINE Dosage & Rx Info | TIGECYCLINE Uses, Side Effects -: Indications, Side Effects, Warnings, TIGECYCLINE - Drug Information - Taj Pharma, TIGECYCLINE dose Taj pharmaceuticals TIGECYCLINE interactions, Taj Pharmaceutical TIGECYCLINE contraindications, TIGECYCLINE price, TIGECYCLINE Taj Pharma Tigecycline 50 mg powder for solution for infusionSMPC- Taj Pharma . Stay connected to all updated on TIGECYCLINE Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Dabigatran was found to be noninferior to warfarin for the treatment of acute venous thromboembolism based on rates of recurrent venous thromboembolism (2.4% vs 2.1%). Major bleeding episodes occurred in 20 patients taking dabigatran compared to 27 taking warfarin, showing similar safety profiles. Dabigatran was as effective as warfarin with a comparable risk of major bleeding, suggesting it could be an alternative oral anticoagulant to warfarin for acute venous thromboembolism.
Schaefer, Joseph, R. Fidaxomicin PresentationJoseph Schaefer
Venugopal and Johnson found that fidaxomicin was effective in treating C. difficile infections while minimizing damage to gut flora. The minimal inhibitory concentration needed to eliminate 90% of C. difficile isolates was lower than for vancomycin and metronidazole. However, sensitivity to these antibiotics decreased over time, suggesting mechanisms of resistance. Artsimovitch, Seddon, and Sears proposed that fidaxomicin inhibits bacterial transcription by binding to and altering the RNA polymerase β' subunit, preventing DNA loading and transcription initiation. Bartsch, Umscheid, Fishman, and Lee found that fidaxomicin is currently not cost-effective compared to vancomycin and metronid
This document summarizes a clinical trial comparing the antibiotic fidaxomicin to vancomycin for the treatment of Clostridium difficile infection (CDI). The trial found that fidaxomicin was non-inferior to vancomycin in achieving clinical cure of CDI. Additionally, fidaxomicin was associated with a significantly lower rate of recurrent CDI compared to vancomycin, especially for non-NAP1/BI/027 strains. However, fidaxomicin is significantly more expensive than vancomycin. The document provides background information on CDI as well as details of the trial design, population, interventions, and results.
The STOPAH trial was a large, multicenter randomized controlled trial that compared prednisolone, pentoxifylline, both, or placebo in over 1,000 patients with severe alcoholic hepatitis. It found that neither prednisolone nor pentoxifylline reduced all-cause mortality at 28 days, the primary outcome. Prednisolone showed a non-significant mortality benefit at 28 days but no benefit at 90 days or 1 year, and was associated with increased infections. The trial demonstrated that neither medication improves short-term survival in severe alcoholic hepatitis.
The document summarizes several drug approvals and updates from the FDA in August 2017. Mavyret was approved for treating HCV genotypes 1-6 without cirrhosis or with compensated cirrhosis. Carospir received approval as an oral suspension for heart failure, hypertension, and hepatic edema. Duzallo was approved as a combination of lesinurad and allopurinol for treating gout in patients not at target uric acid levels on allopurinol alone. Vabomere was approved for complicated UTIs caused by designated bacteria. Other notable approvals included Idhifa for AML, Besponsa for ALL, and Benznidazole for Chagas disease in pediatric patients.
Cinnarizine 15 mg tablets smpc taj pharmaceuticalsTaj Pharma
Cinnarizine Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Cinnarizine Dosage & Rx Info | Cinnarizine Uses, Side Effects -: Indications, Side Effects, Warnings, Cinnarizine - Drug Information - Taj Pharma, Cinnarizine dose Taj pharmaceuticals Cinnarizine interactions, Taj Pharmaceutical Cinnarizine contraindications, Cinnarizine price, Cinnarizine Taj Pharma Cinnarizine 15 mg Tablets SMPC- Taj Pharma . Stay connected to all updated on Cinnarizine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Drug Monograph and Literature Review: "Arcapta Neohaler"Joy Awoniyi
This document provides a drug monograph and literature review for Arcapta Neohaler, which contains indacaterol maleate. It is approved for the treatment of chronic obstructive pulmonary disease (COPD) as a once-daily long-acting beta agonist. The monograph details the drug's indications, dosage forms, mechanism of action, pharmacokinetics, contraindications, warnings, adverse effects, drug interactions, and dosing. It concludes with a review of the literature on indacaterol maleate and COPD treatment.
Levosimendan for Injection Taj Pharma SmPCTajPharmaQC
Levosimendan for Injection 12.5mg, 25mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Levosimendan Dosage & Rx Info | Levosimendan Uses, Side Effects Levosimendan: Indications, Side Effects, Warnings, Levosimendan -Drug Information –Taj Pharma, Levosimendan dose Taj pharmaceuticals Levosimendan interactions, Taj Pharmaceutical Levosimendan contraindications, Levosimendan price, Levosimendan Taj Pharma Levosimendan SmPC-Taj Pharma Stay connected to all updated on Levosimendan Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
The document summarizes several new drug approvals and formulations by the FDA in October and November 2017. Key approvals included:
- Abilify Mycite (aripiprazole tablets with sensor), approved to track drug ingestion in real-time.
- Fasenra (benralizumab), approved for add-on maintenance treatment of severe asthma.
- Prevymis (letermovir), approved to prevent cytomegalovirus infection in transplant recipients.
- Vyzulta (latanoprostene bunod), approved to reduce eye pressure in glaucoma as an alternative to latanoprost.
- Juluca (dolutegra
Bivalirudin for Injection Taj Pharma SmPCTajPharmaQC
Bivalirudin for Injection 250mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Bivalirudin Dosage & Rx Info | Bivalirudin Uses, Side Effects Bivalirudin: Indications, Side Effects, Warnings, Bivalirudin -Drug Information –Taj Pharma, Bivalirudin dose Taj pharmaceuticals Bivalirudin interactions, Taj Pharmaceutical Bivalirudin contraindications, Bivalirudin price, Bivalirudin Taj Pharma Bivalirudin SmPC-Taj Pharma Stay connected to all updated on Bivalirudin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Telaprevir is a protease inhibitor approved to treat genotype 1 chronic hepatitis C in
combination with peginterferon and ribavirin. It works by inhibiting the HCV NS3/4A protease
to prevent viral replication. Several clinical trials found telaprevir combination therapy resulted
in higher rates of undetectable HCV RNA levels and sustained virologic response compared to
peginterferon-ribavirin alone. The most common side effects were rash, pruritis, fatigue, and
gastrointestinal issues. Though telaprevir is associated with more side effects, its ability to
shorten treatment duration and improve outcomes outweighs the increased costs. As such, the
Risperidone 2mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
Risperidone Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Risperidone Dosage & Rx Info | Risperidone Uses, Side Effects -: Indications, Side Effects, Warnings, Risperidone - Drug Information - Taj Pharma, Risperidone dose Taj pharmaceuticals Risperidone interactions, Taj Pharmaceutical Risperidone contraindications, Risperidone price, Risperidone Taj Pharma Risperidone 2mg Film Coated TabletsSMPC- Taj Pharma . Stay connected to all updated on Risperidone Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Nifedipine 30 mg prolonged release tablets smpc taj pharmaceuticalsTaj Pharma
Nifedipine Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Nifedipine Dosage & Rx Info | Nifedipine Uses, Side Effects -: Indications, Side Effects, Warnings, Nifedipine - Drug Information - Taj Pharma, Nifedipine dose Taj pharmaceuticals Nifedipine interactions, Taj Pharmaceutical Nifedipine contraindications, Nifedipine price, Nifedipine Taj Pharma Nifedipine 30mg Prolong Release Tablets SMPC- Taj Pharma . Stay connected to all updated on Nifedipine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Syndros is an oral solution containing dronabinol, a synthetic cannabinoid. It is approved for the treatment of anorexia associated with weight loss in AIDS patients and nausea and vomiting caused by cancer chemotherapy. Syndros works by targeting cannabinoid receptors in the brain to control nausea, vomiting, and appetite. It comes with warnings about potential neurological and hemodynamic side effects and drug interactions. The recommended dosing regimens depend on the condition being treated.
Forzest (Generic Tadalafil Tablets) belongs to a class of medicines called phosphodiesterase-5 (PDE5) inhibitors, is an oral medicine that is used for treating impotence (the inability to attain or maintain a penile erection) and benign prostatic hyperplasia (BPH). The same medicine treats pulmonary arterial hypertension and improves exercise capacity in men and women. Forzest tablets have a very long 17.5 hours half-life as compared with only 4 hours for Sildenafil Citrate.
Simeprevir (Olysio) is a hepatitis C virus (HCV) NS3/4A protease inhibitor approved to treat chronic HCV genotype 1 infection. It is intended for use in combination with peginterferon alfa and ribavirin. The standard treatment duration is 12 weeks of simeprevir along with peginterferon alfa and ribavirin, followed by either 12 or 36 additional weeks of peginterferon alfa and ribavirin depending on prior response. Common side effects during the first 12 weeks of treatment include rash, pruritus, and nausea. Use of simeprevir requires consideration of potential drug interactions and it should not be used as mon
Risperidone Dispersible Tablets Taj Pharma SmPCTajPharmaQC
Risperidone Dispersible Tablets 1mg, 2mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Risperidone Dosage & Rx Info | Risperidone Uses, Side Effects Risperidone: Indications, Side Effects, Warnings, Risperidone-Drug Information –Taj Pharma, Risperidone dose Taj pharmaceuticals Risperidone interactions, Taj Pharmaceutical Risperidone contraindications, Risperidone price, Risperidone Taj Pharma Risperidone SmPC-Taj Pharma Stay connected to all updated on Risperidone Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Telbivudine Tablet 600mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Telbivudine Dosage & Rx Info | Telbivudine Uses, Side Effects Telbivudine: Indications, Side Effects, Warnings, Telbivudine -Drug Information –Taj Pharma, Telbivudine dose Taj pharmaceuticals Telbivudine interactions, Taj Pharmaceutical Telbivudine contraindications, Telbivudine price, Telbivudine Taj Pharma Telbivudine SmPC-Taj Pharma Stay connected to all updated on Telbivudine Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Tigecycline 50 mg powder for solution for infusion smpc taj pharmaceuticalsTaj Pharma
TIGECYCLINE Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, TIGECYCLINE Dosage & Rx Info | TIGECYCLINE Uses, Side Effects -: Indications, Side Effects, Warnings, TIGECYCLINE - Drug Information - Taj Pharma, TIGECYCLINE dose Taj pharmaceuticals TIGECYCLINE interactions, Taj Pharmaceutical TIGECYCLINE contraindications, TIGECYCLINE price, TIGECYCLINE Taj Pharma Tigecycline 50 mg powder for solution for infusionSMPC- Taj Pharma . Stay connected to all updated on TIGECYCLINE Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Dabigatran was found to be noninferior to warfarin for the treatment of acute venous thromboembolism based on rates of recurrent venous thromboembolism (2.4% vs 2.1%). Major bleeding episodes occurred in 20 patients taking dabigatran compared to 27 taking warfarin, showing similar safety profiles. Dabigatran was as effective as warfarin with a comparable risk of major bleeding, suggesting it could be an alternative oral anticoagulant to warfarin for acute venous thromboembolism.
Schaefer, Joseph, R. Fidaxomicin PresentationJoseph Schaefer
Venugopal and Johnson found that fidaxomicin was effective in treating C. difficile infections while minimizing damage to gut flora. The minimal inhibitory concentration needed to eliminate 90% of C. difficile isolates was lower than for vancomycin and metronidazole. However, sensitivity to these antibiotics decreased over time, suggesting mechanisms of resistance. Artsimovitch, Seddon, and Sears proposed that fidaxomicin inhibits bacterial transcription by binding to and altering the RNA polymerase β' subunit, preventing DNA loading and transcription initiation. Bartsch, Umscheid, Fishman, and Lee found that fidaxomicin is currently not cost-effective compared to vancomycin and metronid
This document summarizes a clinical trial comparing the antibiotic fidaxomicin to vancomycin for the treatment of Clostridium difficile infection (CDI). The trial found that fidaxomicin was non-inferior to vancomycin in achieving clinical cure of CDI. Additionally, fidaxomicin was associated with a significantly lower rate of recurrent CDI compared to vancomycin, especially for non-NAP1/BI/027 strains. However, fidaxomicin is significantly more expensive than vancomycin. The document provides background information on CDI as well as details of the trial design, population, interventions, and results.
The STOPAH trial was a large, multicenter randomized controlled trial that compared prednisolone, pentoxifylline, both, or placebo in over 1,000 patients with severe alcoholic hepatitis. It found that neither prednisolone nor pentoxifylline reduced all-cause mortality at 28 days, the primary outcome. Prednisolone showed a non-significant mortality benefit at 28 days but no benefit at 90 days or 1 year, and was associated with increased infections. The trial demonstrated that neither medication improves short-term survival in severe alcoholic hepatitis.
Review Paper – Power Point PresentationFerglapanter
This paper examines the negative effects of religiosity on aggression, education, and intelligence in the United States. It reviews research showing religiosity is correlated with increased aggression due to violent passages in religious texts. Studies also demonstrate religiosity is negatively correlated with education and intelligence, as more religious individuals are less open to knowledge. Polls reveal only 39% of Americans believe in evolution, and belief decreases with increased religious attendance. The research aims to show how religiosity hinders progress in factors contributing to America's development as a modern society.
How to review a journal paper and prepare oral presentationSeppo Karrila
This document provides guidance on reviewing a journal article and preparing and delivering a scientific presentation. It discusses reviewing an article by answering key questions about the topic, approach, results and implications. When preparing a presentation, the document recommends planning for your audience, structuring your content with an introduction outlining the issue, significance and approach, and creating slides that are simple with short text and large, readable figures and tables. It also provides tips for delivering the presentation, such as practicing your timing, using the microphone, and reminding the audience of key points at the end.
This document provides guidance on how to present a journal club. It discusses the definition and history of journal clubs, their aims to keep participants up to date on current literature and teach critical appraisal skills. Journal clubs can cover a range of topics and formats. The document outlines best practices for selecting articles, presenting critically on the content, and facilitating discussion. It emphasizes the benefits of journal clubs for improving knowledge, skills, and evidence-based practice.
TOPIC-ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) COVISHIELD
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory.
approved standard Leaflet based information by serum institute, pune.
at present scenario, its a big challenge to face public with varying queries on vaccination and effects followed by post vaccination
AS a clinical pharmacist we are here to know you the things and helps in leading easier way with respect to safety concerns of the public.
IN these slides the main focus was adverse reactions of vaccine(COVISHIELD) and even at certain point it covers treatment of adverse reactions i.e. paracetamol containing products.
best part of the slides were how to handle ,administer and storage of the vaccine for effective results
exceptions for studies were pharmacokinetic studies and few others like interactions.
The document provides instructions for using the CoronaVac vaccine under an emergency use authorization in Indonesia. Key points include:
- CoronaVac is approved to induce immunity against SARS-CoV-2 and prevent COVID-19 for people aged 18 and older.
- The recommended administration is two 0.5 mL doses given intramuscularly in the deltoid muscle, with doses spaced 2 weeks or 4 weeks apart depending on the situation.
- Common adverse reactions reported in clinical trials were mild to moderate, including pain at the injection site and fatigue.
Vai trò của thuốc kháng virus trong đại dịch Covid 19EfenPhamNgoc
Tocilizumab provided benefit in reducing mortality and improving other outcomes in hospitalized COVID-19 patients in early studies. However, subsequent larger studies found no clear benefit, especially when given later in disease course. The drug may be most effective very early in severe cases, when hyperinflammation is predominant over viral replication. Overall, the efficacy of tocilizumab in COVID-19 remains unclear based on current evidence.
This document provides guidance on initiating COVID-19 oral antiviral treatment in primary care settings. It outlines the clinical staging of COVID-19 disease severity, eligibility criteria for oral antiviral treatment, contraindications, and the process for initiating treatment. Key points include:
- The first-line oral antiviral is Paxlovid (nirmatrelvir/ritonavir), which reduced hospitalization and death by 88% when given within 5 days of symptom onset.
- Patients must be aged 18 or older, have mild to moderate COVID-19 indicated by clinical staging 1-4, and have symptom onset within 5 days to be eligible.
- Contraindications include pregnancy, severe liver or kidney
This document provides an overview of antipsychotic long-acting injections (LAIs). It discusses first and second-generation LAIs, including their pharmacology, advantages, and disadvantages. Specific LAIs covered include fluphenazine, haloperidol, risperidone, paliperidone palmitate, olanzapine, and aripiprazole. The document emphasizes how LAIs can improve adherence and reduce relapse rates compared to oral antipsychotics. It also notes some disadvantages of LAIs, such as injection-related side effects and costs. Overall, the document aims to inform about different LAI options for treating schizophrenia and other psychiatric conditions.
This document provides a nursing student's response to a case study on medications for a patient named Mr. MP. It includes details of the medications, their uses, dosages, side effects and special considerations. It also lists potential problems related to the medications, assessments to monitor for side effects, and healthcare providers to collaborate with including the physician, respiratory therapist, pharmacist, and physical therapist. The student identifies risks of bleeding, infection, and falls and interventions like careful injections, hand washing, and fall precautions. Assessments include respiratory, cardiovascular and musculoskeletal exams.
Direct oral anticoagulants (DOACs) have quickly become attractive alternatives to the long‐standing standard of care in anticoagulation, vitamin K antagonist. DOACs are indicated for prevention and treatment of several cardiovascular conditions. Since the first approval in 2010, DOACs have emerged as leading therapeutic alternatives that provide both clinicians and patients with more effective, safe, and convenient treatment options in thromboembolic settings. With the expanding role of DOACs, clinicians are faced with increasingly complex decisions relating to appropriate agent, duration of treatment, and use in special populations. This review will provide an overview of DOACs and act as a practical reference for clinicians to optimize DOAC use among common challenging scenarios. Topics addressed include (1) appropriate indications; (2) use in patients with specific comorbidities; (3) monitoring parameters; (4) transitioning between anticoagulant regimens; (5) major drug interactions; and (6) cost considerations.
Direct oral anticoagulants (DOACs)—dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), and betrixaban (Bevyxxa) are anticoagulation pharmacotherapy used for the prevention of thrombosis in several cardiovascular contexts.1 DOACs are categorized into 2 main classes: oral direct factor Xa inhibitors (ie, rivaroxaban, apixaban, edoxaban, and betrixaban) and direct thrombin inhibitors (ie, dabigatran). In 2010, the US Food and Drug Administration (FDA) approved its first DOAC, dabigatran, followed by rivaroxaban, apixaban, edoxaban, and betrixaban in the following years. DOACs are relatively new agents demonstrating superiority or noninferiority to prior standards of care, anticoagulation with vitamin K antagonists (VKA; ie, warfarin), or low‐molecular‐weight heparins (LMWHs), in reducing risk of thromboembolic complications with similar or reduced bleeding risk.2, 3, 4, 5 Advantages of DOACs compared with VKAs include fewer monitoring requirements, less frequent follow‐up, more immediate drug onset and offset effects (important for periprocedural and acute bleeding management), and fewer drug and food interactions.6 As a result, DOAC prescriptions exceeded those for warfarin by 2013, with apixaban being the most frequently prescribed DOAC for patients with nonvalvular atrial fibrillation (NVAF).7
Over the past decade, DOACs have been the subject of extensive investigation in many clinical scenarios. Though guidelines and review articles have provided detailed and in‐depth analyses of the immense literature base, these can be too cumbersome and challenging to integrate into everyday clinical use
In general, FDA‐approved indications for each of the DOACs are comparable (see Table 1). Dabigatran, rivaroxaban, apixaban, and edoxaban are approved for the lowering the risk of stroke and embolism in NVAF as well as deep vein thrombosis and pulmonary embolism treatment/prophylaxis.8, 9, 10, 11 Unique indications
This document provides guidelines for COVID-19 management, including highest risk cohorts, drugs used and their mechanisms and side effects. It discusses dexamethasone, enoxaparin, ronapreve, molnupiravir, and IL-6 inhibitors sarilumab and tocilizumab. Dosage and evidence from clinical trials supporting their use are outlined. Side effects including thrombocytopenia, neutropenia and elevated liver enzymes are also noted. The guidelines aim to understand the COVID management algorithm and specific drugs used in treatment.
Nicorandil Tablets BP 10mg, 20mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Nicorandil Dosage & Rx Info | Nicorandil Uses, Side Effects Nicorandil: Indications, Side Effects, Warnings, Nicorandil -Drug Information –Taj Pharma, Nicorandil dose Taj pharmaceuticals Nicorandil interactions, Taj Pharmaceutical Nicorandil contraindications, Nicorandil price, Nicorandil Taj Pharma Nicorandil SmPC-Taj Pharma Stay connected to all updated on Nicorandil Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Ondansetron Oral Solution IP 2mg-5ml Manufacturers, Suppliers in India.pdfTajPharmaIndia
Ondansetron is used to treat nausea and vomiting caused by chemotherapy. It is also used to prevent or treat nausea and vomiting after surgery.
Ondansetron should be considered for infants and children age six months and older who present to the ED with vomiting related to suspected acute gastroenteritis, and who have mild to moderate dehydration or who have failed oral rehydration therapy.
ADAKVEO is indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease. It is administered as a 5 mg/kg intravenous infusion over 30 minutes on Week 0, Week 2, and every 4 weeks thereafter. The most common adverse reactions observed in clinical trials were nausea, arthralgia, back pain, and pyrexia. ADAKVEO has the potential to cause fetal harm based on animal studies and should only be used during pregnancy if the benefit justifies the potential risk to the fetus.
Linezolid 600 mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
Linezolid Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Linezolid Dosage & Rx Info | Linezolid Uses, Side Effects -: Indications, Side Effects, Warnings, Linezolid - Drug Information - Taj Pharma, Linezolid dose Taj pharmaceuticals Linezolid interactions, Taj Pharmaceutical Linezolid contraindications, Linezolid price, Linezolid Taj Pharma Linezolid 600 mg Film-Coated Tablets SMPC- Taj Pharma . Stay connected to all updated on Linezolid Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
This document provides drug information on oxytocin, codeine sulfate, and lidocaine hydrochloride. It includes sections on the generic and brand names, classifications, mechanisms of action, indications, contraindications, adverse reactions, dosages, and nursing considerations for each drug. The nursing considerations sections outline important aspects of patient monitoring, teaching, and safety precautions when administering these drugs.
Anidulafungin for Injection Taj Pharma SmPCTajPharmaQC
Anidulafungin for Injection 100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Anidulafungin Dosage & Rx Info | Anidulafungin Uses, Side Effects Anidulafungin: Indications, Side Effects, Warnings, Anidulafungin -Drug Information –Taj Pharma, Anidulafungin dose Taj pharmaceuticals Anidulafungin interactions, Taj Pharmaceutical Anidulafungin contraindications, Anidulafungin price, Anidulafungin Taj Pharma Anidulafungin SmPC-Taj Pharma Stay connected to all updated on Anidulafungin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Clozapine Tablets USP 25mg, 50mg and 100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Clozapine Dosage & Rx Info | Clozapine Uses, Side Effects Clozapine: Indications, Side Effects, Warnings, Clozapine -Drug Information –Taj Pharma, Clozapine dose Taj pharmaceuticals Clozapine interactions, Taj Pharmaceutical Clozapine contraindications, Clozapine price, Clozapine Taj Pharma Clozapine SmPC-Taj Pharma Stay connected to all updated on Clozapine Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
This document summarizes treatment guidelines for COVID-19 based on disease severity and stage:
- Monoclonal antibodies like Sotrovimab and Bebtelovimab can reduce hospitalization when given early for mild-moderate cases. Antiviral pills Paxlovid and Molnupiravir may also be options.
- For hospitalized patients, remdesivir, corticosteroids like dexamethasone, and IL-6 inhibitors like tocilizumab are recommended. Baricitinib may also help reduce mortality. Remdesivir works best early in hospitalization while corticosteroids are preferred later for patients with ARDS.
- Guidelines discuss optimal dosing of cort
Gefitinib 250 mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
GEFITINIB Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, GEFITINIB Dosage & Rx Info | GEFITINIB Uses, Side Effects -: Indications, Side Effects, Warnings, GEFITINIB - Drug Information - Taj Pharma, GEFITINIB dose Taj pharmaceuticals GEFITINIB interactions, Taj Pharmaceutical GEFITINIB contraindications, GEFITINIB price, GEFITINIB Taj Pharma Cancer, oncologyGefitinib 250 mg film-coated tablets. SMPC- Taj Pharma
I have few drugs which are commonly being used in ICU. The slide contains information related to drug storage, Dosage, Use, Usual concentration use, and things to do and not to do with drug use.
This document summarizes guidelines for prescribing the antipsychotic medication clozapine. It outlines indications for clozapine including treatment-resistant schizophrenia and schizophrenia with suicidal behavior. Contraindications, pharmacology, administration procedures, monitoring requirements, adverse effects, and conclusions are described. Key points include the need for pre-treatment evaluation, slow dose titration, target dosing ranges, plasma level monitoring, potential adverse effects like neutropenia and myocarditis, and long-term maintenance dosing.
This document summarizes guidelines for prescribing the antipsychotic medication clozapine. It outlines indications for clozapine including treatment-resistant schizophrenia and schizophrenia with suicidal behavior. Contraindications, pharmacology, administration procedures, monitoring requirements, adverse effects, and conclusions are described. Key points include the need for pre-treatment evaluation, slow dose titration, target dosing ranges, plasma level monitoring, neutrophil monitoring, and managing side effects like neutropenia, myocarditis, weight gain, and seizures.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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1. HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZINPLAVA safely and effectively. See full prescribing information
for ZINPLAVA.
ZINPLAVA™ (bezlotoxumab) injection, for intravenous use
Initial U.S. Approval: 2016
----------------------------INDICATIONS AND USAGE----------------------------
ZINPLAVA is a human monoclonal antibody that binds to Clostridium
difficile toxin B, indicated to reduce recurrence of Clostridium difficile
infection (CDI) in patients 18 years of age or older who are receiving
antibacterial drug treatment of CDI and are at a high risk for CDI
recurrence. (1)
Limitation of Use:
ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not
an antibacterial drug. ZINPLAVA should only be used in conjunction
with antibacterial drug treatment of CDI. (1)
----------------------- DOSAGE AND ADMINISTRATION -----------------------
Administer ZINPLAVA during antibacterial drug treatment for CDI.
(2.1)
The recommended dose is a single dose of 10 mg/kg
administered as an intravenous infusion over 60 minutes. (2.2)
Dilute prior to intravenous infusion. Administer via a low-protein
binding 0.2 micron to 5 micron in-line or add-on filter. See Full
Prescribing Information for dilution and administration instructions.
(2.3)
--------------------- DOSAGE FORMS AND STRENGTHS ---------------------
Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial. (3)
-------------------------------CONTRAINDICATIONS-------------------------------
None (4)
----------------------- WARNINGS AND PRECAUTIONS -----------------------
Heart Failure: Was reported more commonly in ZINPLAVA-treated
patients with a history of congestive heart failure (CHF) in the two
Phase 3 clinical trials. In patients with a history of CHF, ZINPLAVA
should be reserved for use when the benefit outweighs the risk. (5.1)
------------------------------ ADVERSE REACTIONS ------------------------------
Most common adverse reactions (reported in ≥4% of patients) included
nausea, pyrexia, and headache. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-
888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-
approved patient labeling.
Revised: 10/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Dosing Recommendations in Adults
2.3 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Heart Failure
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information
are not listed.
Reference ID: 4002674
2. FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
ZINPLAVA™ is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18
years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI
recurrence.
Limitation of Use:
ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug.
ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI. [See Dosage and
Administration (2.1).]
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
Administer ZINPLAVA during antibacterial drug treatment for CDI.
2.2 Dosing Recommendations in Adults
The recommended dose of ZINPLAVA is a single dose of 10 mg/kg administered as an
intravenous infusion over 60 minutes. The safety and efficacy of repeat administration of ZINPLAVA in
patients with CDI have not been studied.
2.3 Preparation and Administration
Preparation of Diluted Solution
ZINPLAVA must be diluted prior to intravenous infusion.
Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the
vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation
of the diluted solution.
Inspect vial contents for discoloration and particulate matter prior to dilution. ZINPLAVA is a clear to
moderately opalescent, colorless to pale yellow solution. Do not use the vial if the solution is
discolored or contains visible particles.
Do not shake the vial.
Withdraw the required volume from the vial(s) based on the patient’s weight (in kg) and transfer into
an intravenous bag containing either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection,
USP to prepare a diluted solution with a final concentration ranging from 1 mg/mL to 10 mg/mL. Mix
diluted solution by gentle inversion. Do not shake.
Discard vial(s) and all unused contents.
Storage of Diluted Solution
The product does not contain preservative. The diluted solution of ZINPLAVA may be stored either at
room temperature for up to 16 hours or under refrigeration at 2°C to 8°C (36°F to 46°F) for up to
24 hours. If refrigerated, allow the intravenous bag to come to room temperature prior to use.
These time limits include storage of the infusion solution in the intravenous bag through the duration
of infusion.
Do not freeze the diluted solution.
Administration
Administer the diluted solution as an intravenous infusion over 60 minutes using a sterile, non
pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
The diluted solution can be infused via a central line or peripheral catheter. Do not administer
ZINPLAVA as an intravenous push or bolus.
Do not co-administer other drugs simultaneously through the same infusion line.
2
Reference ID: 4002674
3. 3 DOSAGE FORMS AND STRENGTHS
Injection: 1,000 mg/40 mL (25 mg/mL) clear to moderately opalescent, colorless to pale yellow
solution in a single-dose vial.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Heart Failure
Heart failure was reported more commonly in the two Phase 3 clinical trials in ZINPLAVA-treated
patients compared to placebo-treated patients. These adverse reactions occurred primarily in patients
with underlying congestive heart failure (CHF). In patients with a history of CHF, 12.7% (15/118) of
ZINPLAVA-treated patients and 4.8% (5/104) of placebo-treated patients had the serious adverse
reaction of heart failure during the 12-week study period [see Adverse Reactions (6.1)]. Additionally, in
patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients, 19.5% (23/118)
than in placebo-treated patients, 12.5% (13/104) during the 12-week study period. The causes of death
varied and included cardiac failure, infections, and respiratory failure.
In patients with a history of CHF, ZINPLAVA should be reserved for use when the benefit outweighs
the risk.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.
The safety of ZINPLAVA was evaluated in two placebo-controlled, Phase 3 trials (Trial 1 n= 390
and Trial 2 n= 396). Patients received a single 10 mg/kg intravenous infusion of ZINPLAVA and
concomitant standard of care antibacterial drugs (metronidazole, vancomycin or fidaxomicin) for CDI
(SoC). Adverse reactions reported within the first 4 weeks after ZINPLAVA was administered are
described for the pooled Phase 3 trial population of 786 patients. The median age of patients receiving
ZINPLAVA was 65 years (range 18 to 100), 50% were age 65 years or older, 56% were female, and 83%
were white.
The most common adverse reactions following treatment with ZINPLAVA (reported in ≥4% of
patients within the first 4 weeks of infusion and with a frequency greater than placebo) were nausea,
pyrexia, and headache (see Table 1).
3
Reference ID: 4002674
4. Table 1: Adverse Reactions Reported in ≥4% of ZINPLAVA-Treated Patients with CDI and at a
Frequency Greater than Placebo in Trial 1 and Trial 2*,†
Adverse Reaction
ZINPLAVA with SoC‡
N=786
%
Placebo with SoC‡
N=781
%
Gastrointestinal disorders
Nausea 7% 5%
General disorders and administration site conditions
Pyrexia 5% 3%
Nervous system disorders
Headache 4% 3%
* All patients as treated population, defined as all randomized patients who received a dose of study medication, by
treatment received
†
Adverse reactions reported within 4 weeks of administration of ZINPLAVA or placebo
‡
SoC = Standard of Care antibacterial drugs (metronidazole or vancomycin or fidaxomicin) for CDI
Serious adverse reactions occurring within 12 weeks following infusion were reported in 29% of
ZINPLAVA-treated patients and 33% of placebo-treated patients. Heart failure was reported as a serious
adverse reaction in 2.3% of the ZINPLAVA-treated patients and 1.0% of the placebo-treated patients [see
Warnings and Precautions (5.1)].
One patient discontinued the ZINPLAVA infusion due to ventricular tachyarrhythmia that occurred
30 minutes after the start of the infusion.
Mortality rates were 7.1% and 7.6% in ZINPLAVA-treated patients and placebo-treated patients,
respectively, during the 12-week follow-up period.
Infusion Related Reactions
Overall, 10% of ZINPLAVA-treated patients experienced one or more infusion specific adverse
reactions on the day of, or the day after, the infusion compared to 8% of placebo-treated patients.
Infusion specific adverse reactions reported in ≥0.5% of patients receiving ZINPLAVA and at a frequency
greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%),
dyspnea (1%) and hypertension (1%). Of these patients, 78% and 20% of patients experienced mild and
moderate adverse reactions, respectively. These reactions resolved within 24 hours following onset.
6.2 Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity following administration of
ZINPLAVA. The detection of antibody formation is highly dependent on the sensitivity and specificity of
the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in
an assay may be influenced by several factors including assay methodology, sample handling, timing of
sample collection, concomitant medications, and underlying disease. For these reasons, comparison of
the incidence of antibodies to bezlotoxumab in the studies described below with the incidence of
antibodies in other studies or to other products may be misleading.
Following treatment with ZINPLAVA in Trial 1 and Trial 2, none of the 710 evaluable patients tested
positive for treatment-emergent anti-bezlotoxumab antibodies.
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5. 7 DRUG INTERACTIONS
Since ZINPLAVA is eliminated by catabolism, no metabolic drug-drug interactions are expected
[see Clinical Pharmacology (12.3)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Adequate and well controlled studies with ZINPLAVA have not been conducted in pregnant women.
No animal reproductive and developmental studies have been conducted with bezlotoxumab.
The background risk of major birth defects and miscarriage for the indicated population is unknown;
however, the background risk in the U.S. general population of major birth defects is 2-4% and of
miscarriage is 15-20% of clinically recognized pregnancies.
8.2 Lactation
Risk Summary
There is no information regarding the presence of bezlotoxumab in human milk, the effects on the
breast-fed infant, or the effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the
mother’s clinical need for ZINPLAVA and any potential adverse effects on the breastfed child from
ZINPLAVA or from the underlying maternal condition.
8.4 Pediatric Use
Safety and efficacy of ZINPLAVA in patients below 18 years of age have not been established.
8.5 Geriatric Use
Of the 786 patients treated with ZINPLAVA, 50% were 65 years of age and over, and 27% were
75 years of age and over. No overall differences in safety and efficacy were observed between these
subjects and younger subjects [see Clinical Studies (14)]. No dose adjustment is necessary for patients
≥65 years of age [see Clinical Pharmacology (12.3)].
10 OVERDOSAGE
There is no clinical experience with overdosage of ZINPLAVA. In case of overdose, patients should
be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment
should be instituted.
11 DESCRIPTION
Bezlotoxumab is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its
effects. Bezlotoxumab is an IgG1 immunoglobulin with an approximate molecular weight of 148.2 kDa.
ZINPLAVA (bezlotoxumab) Injection is a sterile, preservative-free, clear to moderately opalescent,
colorless to pale yellow solution that requires dilution for intravenous infusion. The product is provided in
a 50 mL vial that contains 1000 mg of bezlotoxumab in 40 mL of solution. Each mL of solution contains
bezlotoxumab (25 mg), citric acid monohydrate (0.8 mg), diethylenetriaminepentaacetic acid (0.0078 mg),
polysorbate 80 (0.25 mg), sodium chloride (8.77 mg), sodium citrate dihydrate (4.75 mg), and Water for
Injection, USP. The vial may contain sodium hydroxide to adjust the pH to 6.0.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
ZINPLAVA (bezlotoxumab) is a human monoclonal antibody that binds to C. difficile toxin B and
neutralizes its effects [see Microbiology (12.4)].
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6. 12.3 Pharmacokinetics
The pharmacokinetics of bezlotoxumab were studied in 1515 CDI patients in two Phase 3 trials
(Trial 1 and Trial 2). Based on a population PK analysis, the geometric mean (%CV) clearance of
bezlotoxumab was 0.317 L/day (41%), with a mean volume of distribution of 7.33 L (16%), and
elimination half-life (t½) of approximately 19 days (28%). After a single intravenous dose of 10 mg/kg
bezlotoxumab, geometric mean AUC0-INF and Cmax were 53000 mcg·h/mL and 185 mcg/mL, respectively,
in the patients with CDI. The clearance of bezlotoxumab increased with increasing body weight; the
resulting exposure differences are adequately addressed by the administration of a weight-based dose.
Bezlotoxumab is eliminated by catabolism.
Specific Populations
Gender, Race, Ethnicity, and Co-Morbid Conditions
The following factors had no clinically meaningful effect on the exposure of bezlotoxumab: gender,
race, ethnicity, and presence of co-morbid conditions.
Patients with Renal Impairment
The effect of renal impairment on the pharmacokinetics of bezlotoxumab was evaluated in patients
with mild (eGFR 60 to <90 mL/min/1.73 m2
), moderate (eGFR 30 to <60 mL/min/1.73 m2
), or severe
(eGFR 15 to <30 mL/min/1.73 m2
) renal impairment, or with end stage renal disease (eGFR
<15 mL/min/1.73 m2
), as compared to patients with normal (eGFR ≥90 mL/min/1.73 m2
) renal function.
No clinically meaningful differences in the exposure of bezlotoxumab were found between patients with
renal impairment and patients with normal renal function.
Patients with Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of bezlotoxumab was evaluated in
patients with hepatic impairment (defined as having two or more of the following: [1] albumin ≤3.1 g/dL; [2]
ALT ≥2X ULN; [3] total bilirubin ≥1.3X ULN; or [4] mild, moderate or severe liver disease as reported by
the Charlson Co-morbidity Index), as compared to patients with normal hepatic function. No clinically
meaningful differences in the exposure of bezlotoxumab were found between patients with hepatic
impairment and patients with normal hepatic function.
Geriatric Patients
The effect of age on the pharmacokinetics of bezlotoxumab was evaluated in patients ranging from
18 to 100 years of age. No clinically meaningful differences in the exposure of bezlotoxumab were found
between patients 65 years and older and patients under 65 years of age.
Drug Interaction Studies
Because bezlotoxumab is eliminated by catabolism, no metabolic drug-drug interactions are
expected.
12.4 Microbiology
Mechanism of Action
Bezlotoxumab is a human monoclonal antibody that binds C. difficile toxin B with an equilibrium
dissociation constant (Kd) of <1×10-9
M. Bezlotoxumab inhibits the binding of toxin B and prevents its
effects on mammalian cells. Bezlotoxumab does not bind to C. difficile toxin A.
Activity In Vitro
Bezlotoxumab binds to an epitope on toxin B that is conserved across reported strains of C. difficile,
although amino acid sequence variation within the epitope does occur. In vitro studies in cell-based
assays using Vero cells or Caco-2 cells, suggest that bezlotoxumab neutralizes the toxic effects of
toxin B.
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7. 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been performed to test the potential of bezlotoxumab for carcinogenicity or
genotoxicity.
Fertility studies have not been conducted with bezlotoxumab.
14 CLINICAL STUDIES
The safety and efficacy of ZINPLAVA were investigated in two randomized, double-blind, placebo-
controlled, multicenter, Phase 3 trials (Trial 1 and Trial 2) in patients receiving Standard of Care
antibacterial drugs for treatment of CDI (SoC). Randomization was stratified by SoC (metronidazole,
vancomycin, or fidaxomicin) and hospitalization status (inpatient vs. outpatient) at the time of study entry.
Enrolled patients were 18 years of age or older and had a confirmed diagnosis of CDI, which was
defined as diarrhea (passage of 3 or more loose bowel movements in 24 or fewer hours) and a positive
stool test for toxigenic C. difficile from a stool sample collected no more than 7 days before study entry.
Patients were excluded if surgery for CDI was planned, or if they had uncontrolled chronic diarrheal
illness. Patients received a 10- to 14-day course of oral SoC and a single infusion of ZINPLAVA or
placebo was administered during the course of SoC. Patients on oral vancomycin or oral fidaxomicin
could have also received intravenous metronidazole. Choice of SoC was at the discretion of the health
care provider. The day of the infusion of ZINPLAVA or placebo in relation to the start of SoC ranged from
the day prior to the start of SoC to 14 days after the start of SoC with the median being day 3 of SoC.
In Trial 1, 403 patients were randomized to receive ZINPLAVA and 404 patients were randomized
to receive placebo. In Trial 2, 407 subjects were randomized to receive ZINPLAVA and 399 patients were
randomized to receive placebo. The Full Analysis Set (FAS) was a subset of all randomized subjects with
exclusions for: (i) not receiving infusion of study medication; (ii) not having a positive local stool test for
toxigenic C. difficile; (iii) not receiving protocol defined standard of care therapy within a 1 day window of
the infusion. The baseline characteristics of the 1554 patients randomized to ZINPLAVA or placebo in the
FAS were similar across treatment arms and in Trial 1 and Trial 2. The median age was 65 years, 85%
were white, 57% were female, and 68% were inpatients. A similar proportion of patients received oral
metronidazole (48%) or oral vancomycin (48%) and 4% of the patients received oral fidaxomicin as their
SoC.
The following risk factors associated with a high risk of CDI recurrence or CDI-related adverse
outcomes were present in the study population: 51% were ≥65 years of age, 39% received one or more
systemic antibacterial drugs (during the 12-week follow-up period), 28% had one or more episodes of CDI
within the six months prior to the episode under treatment (15% had two or more episodes prior to the
episode under treatment), 21% were immunocompromised and 16% presented at study entry with
clinically severe CDI (as defined by a Zar score of ≥2
1
). A hypervirulent strain (ribotypes 027, 078 or 244)
was isolated in 22% of patients who had a positive baseline culture, of which 87% (189 of 217 strains)
were ribotype 027.
Patients were assessed for clinical cure of the presenting CDI episode, defined as no diarrhea for 2
consecutive days following the completion of a ≤14 day SoC regimen. Patients who achieved clinical cure
were then assessed for recurrence of CDI through 12 weeks following administration of the infusion of
ZINPLAVA or placebo. CDI recurrence was defined as the development of a new episode of diarrhea
associated with a positive stool test for toxigenic C. difficile following clinical cure of the presenting CDI
episode. Sustained clinical response was defined as clinical cure of the presenting CDI episode and no
CDI recurrence through 12 weeks after infusion. Table 2 contains the results for Trial 1 and Trial 2.
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8. Table 2: Efficacy Results Through 12 Weeks After Infusion
(Trial 1 and Trial 2, Full Analysis Set*)
Trial ZINPLAVA with
SoC†
Placebo
with SoC†
Adjusted Difference
(95% CI)‡
n (%) n (%)
1 N=386 N=395
Sustained clinical 232 (60.1) 218 (55.2) 4.8 (-2.1, 11.7)
response
Reasons for failure to achieve sustained clinical response:
Clinical failure 87 (22.5) 68 (17.2)
Recurrence 67 (17.4) 109 (27.6)
2 N=395 N=378
Sustained clinical 264 (66.8) 197 (52.1) 14.6 (7.7, 21.4)
response
Reasons for failure to achieve sustained clinical response:
Clinical failure 69 (17.5) 84 (22.2)
Recurrence 62 (15.7) 97 (25.7)
n (%) = Number (percentage) of subjects in the analysis population meeting the criteria for endpoint
N = Number of subjects included in the analysis population
* Full Analysis Set = a subset of all randomized subjects with exclusions for: (i) did not receive infusion of study
medication; (ii) did not have a positive local stool test for toxigenic C. difficile; (iii) did not receive protocol defined
standard of care therapy within a 1 day window of the infusion
†
SoC = Standard of Care antibacterial drugs (metronidazole or vancomycin or fidaxomicin) for CDI
‡
Adjusted difference of ZINPLAVA-placebo (95% confidence interval) based on Miettinen and Nurminen method
stratified by SoC antibacterial drugs (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status
(inpatient vs. outpatient).
In Trial 1, the clinical cure rate of the presenting CDI episode was lower in the ZINPLAVA arm as
compared to the placebo arm and in Trial 2, the clinical cure rate was lower in the placebo arm compared
to the ZINPLAVA arm. Patients in the ZINPLAVA and placebo arms who did not achieve clinical cure of
the presenting CDI episode (no diarrhea for 2 consecutive days following the completion of a ≤14 day
SoC regimen) received a mean of 18 to 19 days of SoC and had a mean of 4 additional days of diarrhea
following completion of SoC. Additional analyses showed that by 3 weeks post study drug infusion the
clinical cure rates of the presenting CDI episode were similar between treatment arms.
Efficacy results in patients at high risk for CDI recurrence (i.e., patients aged 65 years and older,
with a history of CDI in the past 6 months, immunocompromised state, severe CDI at presentation, or
C. difficile ribotype 027) were consistent with the efficacy results in the overall trial population in Trials 1
and 2.
15 REFERENCES
1. Zar FA, Bakkanagari SR, Moorthi KM, Davis MB. A comparison of vancomycin and
metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease
severity. Clin Infect Dis 2007;45(3):302-7.
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10.
Patient Information
ZINPLAVA™ (zin-PLAH-va)
(bezlotoxumab)
injection, for intravenous use
What you need to know about ZINPLAVA
Before you receive ZINPLAVA, be sure you understand what it is for and how it is given.
ZINPLAVA helps decrease the risk of C-diff (Clostridium difficile infection) from coming back by working with
the antibiotic that you are taking to treat your C-diff. ZINPLAVA does not replace the antibiotic. ZINPLAVA is
not an antibiotic.
Keep taking your antibiotic for your C-diff as directed by your doctor.
If you have questions about ZINPLAVA, ask your doctor or pharmacist.
Keep this Patient Information for ZINPLAVA so you can read it again.
What is ZINPLAVA?
ZINPLAVA is a prescription medicine used to help decrease the risk of C-diff from coming back in people 18 years of age
or older who are taking an antibiotic for C-diff and who have a high risk of C-diff coming back.
C-diff is a bacterial infection that can damage your colon and cause stomach pain and severe diarrhea. When people get
C-diff, they often take an antibiotic to get rid of the infection. Even when treated by an antibiotic, C-diff can come back
within weeks to months. ZINPLAVA helps to decrease the risk of the infection from coming back. It works when given
along with the antibiotic that you are taking to treat C-diff.
How will I receive ZINPLAVA?
You will receive ZINPLAVA into your vein through an IV (intravenously).
You do not need to do anything to prepare for receiving ZINPLAVA.
You will receive ZINPLAVA in 1 dose and it will take about 1 hour.
If you miss your appointment, call your doctor right away to reschedule it.
Is ZINPLAVA right for me?
Children
It is not known if ZINPLAVA is safe and effective in children under 18 years old.
Pregnancy
If you are pregnant or trying to get pregnant, tell your doctor before you receive ZINPLAVA.
It is not known if ZINPLAVA will harm your baby while you are pregnant.
You and your doctor should decide together if you will receive ZINPLAVA.
Breastfeeding
If you are breastfeeding or plan to breastfeed, tell your doctor before you receive ZINPLAVA.
It is not known if ZINPLAVA gets in your breast milk and will be passed to your baby.
You and your doctor should decide together if you will receive ZINPLAVA.
Medical Conditions
Tell your doctor about any medical conditions you have now or have had before.
Make sure to tell your doctor if you have or have had congestive heart failure (CHF).
Other Medicines
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
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