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This document discusses tumor markers and treatments for various types of ovarian cancer. It outlines several tumor markers - BRCA1/2, CA-125, HE4, HER2/neu, and OVA1 - that are analyzed in blood and/or tumors to determine cancer type and guide treatment decisions. For stage III or IV ovarian cancer, intraperitoneal chemotherapy may be given in addition to intravenous chemotherapy. Regimens discussed include paclitaxel and cisplatin. PARP inhibitors are approved for platinum-sensitive or BRCA-mutated recurrent ovarian cancer. Hormonal therapies and carboplatin-based chemotherapy are options for elderly patients or those who cannot tolerate standard treatments.
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This document discusses tumor markers and treatments for various types of ovarian cancer. It outlines several tumor markers - BRCA1/2, CA-125, HE4, HER2/neu, and OVA1 - that are analyzed in blood and/or tumors to determine cancer type and guide treatment decisions. For stage III or IV ovarian cancer, intraperitoneal chemotherapy may be given in addition to intravenous chemotherapy. Regimens discussed include paclitaxel and cisplatin. PARP inhibitors are approved for platinum-sensitive or BRCA-mutated recurrent ovarian cancer. Hormonal therapies and carboplatin-based chemotherapy are options for elderly patients or those who cannot tolerate standard treatments.
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Bleomycin for Injection 15 Units, 30 Units Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Bleomycin Dosage & Rx Info | Bleomycin Uses, Side Effects Bleomycin: Indications, Side Effects, Warnings, Bleomycin -Drug Information –Taj Pharma, Bleomycin dose Taj pharmaceuticals Bleomycin interactions, Taj Pharmaceutical Bleomycin contraindications, Bleomycin price, Bleomycin Taj Pharma Bleomycin SmPC-Taj Pharma Stay connected to all updated on Bleomycin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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Simvastatin Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Simvastatin Dosage & Rx Info | Simvastatin Uses, Side Effects -: Indications, Side Effects, Warnings, Simvastatin - Drug Information - Taj Pharma, Simvastatin dose Taj pharmaceuticals Simvastatin interactions, Taj Pharmaceutical Simvastatin contraindications, Simvastatin price, Simvastatin Taj Pharma Simvastatin 20mg Film Coated Tablets SMPC- Taj Pharma . Stay connected to all updated on Simvastatin Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Captopril Tablets SmPC Taj PharmaceuticalsTajPharmaQC
Captopril Tablets USP 25mg, 50mg, 100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Captopril Dosage & Rx Info | Captopril Uses, Side Effects Captopril: Indications, Side Effects, Warnings, Captopril -Drug Information –Taj Pharma, Captopril dose Taj pharmaceuticals Captopril interactions, Taj Pharmaceutical Captopril contraindications, Captopril price, Captopril Taj Pharma Captopril SmPC- Taj Pharma Stay connected to all updated on Captopril Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Daptomycin for Injection Taj Pharma SmPCTajPharmaQC
Daptomycin for Injection or Infusion 350mg, 500mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Daptomycin Dosage & Rx Info | Daptomycin Uses, Side Effects Daptomycin: Indications, Side Effects, Warnings, Daptomycin -Drug Information –Taj Pharma, Daptomycin dose Taj pharmaceuticals Daptomycin interactions, Taj Pharmaceutical Daptomycin contraindications, Daptomycin price, Daptomycin Taj Pharma Daptomycin SmPC-Taj Pharma Stay connected to all updated on Daptomycin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Atorvastatin 40 mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
Atorvastatin 40mg Tablets Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Atorvastatin Dosage & Rx Info | Atorvastatin Uses, Side Effects - Atorvastatin : Indications, Side Effects, Warnings, Atorvastatin - Drug Information - Taj Pharma, Atorvastatin dose Taj pharmaceuticals Atorvastatin interactions, Taj Pharmaceutical Atorvastatin contraindications, Atorvastatin price, Atorvastatin Taj Pharma anti-arrhythmics Atorvastatin 40 mg film-coated tablets SMPC- Taj Pharma . Stay connected to all updated on Atorvastatin Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Bicalutamide Tablets USP Taj Pharma SmPCTajPharmaQC
Bicalutamide Tablets USP 50mg/150mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Bicalutamide Dosage & Rx Info | Bicalutamide Uses, Side Effects Bicalutamide : Indications, Side Effects, Warnings, Bicalutamide -Drug Information –Taj Pharma, Bicalutamide dose Taj pharmaceuticals Bicalutamide interactions, Taj Pharmaceutical Bicalutamide contraindications, Bicalutamide price, Bicalutamide Taj Pharma Bicalutamide SmPC-Taj Pharma Stay connected to all updated on Bicalutamide Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Imatinib Capsules 100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Imatinib Dosage & Rx Info | Imatinib Uses, Side Effects Imatinib: Indications, Side Effects, Warnings, Imatinib -Drug Information –Taj Pharma, Imatinib dose Taj pharmaceuticals Imatinib interactions, Taj Pharmaceutical Imatinib contraindications, Imatinib price, Imatinib Taj Pharma Imatinib SmPC-Taj Pharma Stay connected to all updated on Imatinib Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Gefitinib Tablets 25mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Gefitinib Dosage & Rx Info | Gefitinib Uses, Side Effects Gefitinib: Indications, Side Effects, Warnings, Gefitinib -Drug Information –Taj Pharma, Gefitinib dose Taj pharmaceuticals Gefitinib interactions, Taj Pharmaceutical Gefitinib contraindications, Gefitinib price, Gefitinib Taj Pharma Gefitinib SmPC-Taj Pharma Stay connected to all updated on Gefitinib Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Crizotinib 200mg/250mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Crizotinib Dosage & Rx Info | Crizotinib Uses, Side Effects Crizotinib: Indications, Side Effects, Warnings, Crizotinib -Drug Information –Taj Pharma, Crizotinib dose Taj pharmaceuticals Crizotinib interactions, Taj Pharmaceutical Crizotinib contraindications, Crizotinib price, Crizotinib Taj Pharma Crizotinib SmPC-Taj Pharma Stay connected to all updated on Crizotinib Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Paclitaxel 6 mgml concentrate for solution for infusion smpc taj pharmaceuti...Taj Pharma
PACLITAXEL Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, PACLITAXEL Dosage & Rx Info | PACLITAXEL Uses, Side Effects -: Indications, Side Effects, Warnings, PACLITAXEL - Drug Information - Taj Pharma, PACLITAXEL dose Taj pharmaceuticals PACLITAXEL interactions, Taj Pharmaceutical PACLITAXEL contraindications, PACLITAXEL price, PACLITAXEL Taj Pharma Paclitaxel 6 mg/ml concentrate for solution for infusionSMPC- Taj Pharma . Stay connected to all updated on PACLITAXEL Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Quetiapine 25mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
Quetiapine Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Quetiapine Dosage & Rx Info | Quetiapine Uses, Side Effects -: Indications, Side Effects, Warnings, Quetiapine - Drug Information - Taj Pharma, Quetiapine dose Taj pharmaceuticals Quetiapine interactions, Taj Pharmaceutical Quetiapine contraindications, Quetiapine price, Quetiapine Taj Pharma Cancer, oncologyQuetiapine 25mg Film Coated Tablets SMPC- Taj Pharma . Stay connected to all updated on Quetiapine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Imatinib, 400mg, 100mg, film coated tablets smpc- taj pharmaceuticalsTaj Pharma
IMATINIB Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, IMATINIB Dosage & Rx Info | IMATINIB Uses, Side Effects -: Indications, Side Effects, Warnings, IMATINIB - Drug Information - Taj Pharma, IMATINIB dose Taj pharmaceuticals IMATINIB interactions, Taj Pharmaceutical IMATINIB contraindications, IMATINIB price, IMATINIB Taj Pharma Cancer, oncologyImatinib, 400mg, 100mg, film-coated tablets. SMPC- Taj Pharma . Stay connected to all updated on IMATINIB Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Carboplatin 10 mgml intravenous infusion smpc taj pharmaceuticalsTaj Pharma
CARBOPLATIN - Drug Information - Taj Pharma, CARBOPLATIN dose Taj pharmaceuticals CARBOPLATINinteractions, Taj Pharmaceutical CARBOPLATIN contraindications, CARBOPLATIN price, CARBOPLATIN Taj Pharma Cancer, oncologyCarboplatin 10 mg/ml Intravenous Infusion SMPC- Taj Pharma . Stay connected to all updated on CARBOPLATIN Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
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
Cabazitaxel 60 mg concentrate and solvent for solution for infusion smpc taj...Taj Pharma
CABAZITAXEL - Drug Information - Taj Pharma, CABAZITAXEL dose Taj pharmaceuticals CABAZITAXEL interactions, Taj Pharmaceutical CABAZITAXEL contraindications, CABAZITAXEL price, CABAZITAXEL Taj Pharma Cancer, oncologyCABAZITAXEL 60 mg concentrate and solvent for solution for infusion. SMPC- Taj Pharma . Stay connected to all updated on CABAZITAXEL Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Imatinib Tablets 100mg/400mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Imatinib Dosage & Rx Info | Imatinib Uses, Side Effects Imatinib: Indications, Side Effects, Warnings, Imatinib -Drug Information –Taj Pharma, Imatinib dose Taj pharmaceuticals Imatinib interactions, Taj Pharmaceutical Imatinib contraindications, Imatinib price, Imatinib Taj Pharma Imatinib SmPC-Taj Pharma Stay connected to all updated on Imatinib Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Ceritinib is an antineoplastic agent approved for the treatment of adults with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on crizotinib. The recommended dosage is 750 mg once daily. Dosage reductions may be necessary due to common adverse effects like gastrointestinal toxicity, hepatotoxicity, interstitial lung disease, QT prolongation, hyperglycemia, and bradycardia. Ceritinib carries warnings for severe gastrointestinal toxicity, hepatotoxicity, interstitial lung disease, QT prolongation, hyperglycemia, and bradycardia.
Micafungin for Injection Taj Pharma SmPCTajPharmaQC
Micafungin for Injection 50mg, 100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Micafungin Dosage & Rx Info | Micafungin Uses, Side Effects Micafungin: Indications, Side Effects, Warnings, Micafungin -Drug Information –Taj Pharma, Micafungin dose Taj pharmaceuticals Micafungin interactions, Taj Pharmaceutical Micafungin contraindications, Micafungin price, Micafungin Taj Pharma Micafungin SmPC-Taj Pharma Stay connected to all updated on Micafungin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Pemetrexed (Alimta) is an intravenous chemotherapy drug used to treat nonsquamous non-small cell lung cancer and mesothelioma. It is given as a 10 minute infusion every 21 days at a dose of 500 mg/m2. Patients should take folic acid and vitamin B12 supplements to reduce side effects. Dose reductions may be needed for hematologic or nonhematologic toxicities. Pemetrexed can interact with NSAIDs and nephrotoxic drugs. It is not recommended in pregnancy or for pediatric patients.
Gentamicin and the Yorkshire-Hartford RegimenKev Frost
This document provides information on gentamicin, an aminoglycoside antibiotic. It discusses gentamicin's mechanism of action, pharmacokinetics, dosing regimens including the Hartford extended interval regimen, and monitoring requirements. The Hartford regimen aims to maximize bacterial killing while minimizing toxicity by administering a once daily gentamicin dose and monitoring serum levels to determine subsequent dosing intervals.
Vivitra 150mg injection consist a targeted cancer drug known as Trastuzumab, which is Pharmacologically grouped as humanized monoclonal antibody produced by recombinant DNA technology
Epirubicin hydrochloride 2 mgml solution for injection or infusion smpc taj ...Taj Pharma
EPIRUBICIN HYDROCHLORIDE - Drug Information - Taj Pharma, EPIRUBICIN HYDROCHLORIDE dose Taj pharmaceuticals EPIRUBICIN HYDROCHLORIDE interactions, Taj Pharmaceutical EPIRUBICIN HYDROCHLORIDE contraindications, EPIRUBICIN HYDROCHLORIDE price, EPIRUBICIN HYDROCHLORIDE Taj Pharma Cancer, oncologyEpirubicin Hydrochloride 2mg/ml solution for injection or infusion SMPC- Taj Pharma . Stay connected to all updated on EPIRUBICIN HYDROCHLORIDE Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Gabapentin 300mg capsules smpc taj pharmaceuticalsTaj Pharma
Gabapentin Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Gabapentin Dosage & Rx Info | Gabapentin Uses, Side Effects -: Indications, Side Effects, Warnings, Gabapentin - Drug Information - Taj Pharma, Gabapentin dose Taj pharmaceuticals Gabapentin interactions, Taj Pharmaceutical Gabapentin contraindications, Gabapentin price, Gabapentin Taj Pharma Gabapentin 300mg capsules SMPC- Taj Pharma . Stay connected to all updated on Gabapentin Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Pregabalin SR Capsules Sustained Release 100mg/150mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Pregabalin Dosage & Rx Info | Pregabalin Uses, Side Effects Vecuronium bromide: Indications, Side Effects, Warnings, Pregabalin-Drug Information –Taj Pharma, Pregabalin dose Taj pharmaceuticals Pregabalin interactions, Taj Pharmaceutical Pregabalin contraindications, Pregabalin price, Pregabalin Taj Pharma Pregabalin SmPC-Taj Pharma Stay connected to all updated on Pregabalin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Similar to Gemcitabine for Injection USP Taj Pharma SmPC (18)
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.
Raltegravir Tablets USP Taj Pharma SmPCTajPharmaQC
Raltegravir Tablet USP 25mg/100mg/400mg/600mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Raltegravir Dosage & Rx Info | Raltegravir Uses, Side Effects Raltegravir: Indications, Side Effects, Warnings, Raltegravir -Drug Information –Taj Pharma, Raltegravir dose Taj pharmaceuticals Raltegravir interactions, Taj Pharmaceutical Raltegravir contraindications, Raltegravir price, Raltegravir Taj Pharma Raltegravir SmPC-Taj Pharma Stay connected to all updated on Raltegravir Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Perindopril Arginine Tablets USP Taj Pharma PILTajPharmaQC
This document provides information on Perindopril Arginine Tablets produced by Taj Pharma, including its uses, side effects, dosage, interactions and warnings. It is used to treat high blood pressure, heart failure and reduce cardiac risks. Common side effects include severe stomach/abdominal pain. It should not be used in pregnancy or by those allergic to its ingredients. Caution is advised when taking it with other medications due to potential interactions.
Linezolid Tablets USP 600mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Linezolid Dosage & Rx Info | Linezolid Uses, Side Effects Linezolid: 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 SmPC-Taj Pharma Stay connected to all updated on Linezolid Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
This document provides information on lacosamide tablets produced by Taj Pharma, including:
- It describes the composition, pharmaceutical form, clinical uses, dosages, and administration details for lacosamide tablets in 50mg, 100mg, 150mg, and 200mg strengths.
- The tablets are indicated as monotherapy or adjunctive therapy for partial-onset seizures. Common side effects include nausea and vomiting. Special populations may require adjusted dosages.
- Detailed posology and dosage adjustment recommendations are provided for various patient populations including children, elderly patients, and those with renal or hepatic impairment.
Enalapril Maleate/HCT Delayed-Release capsules USP Taj Pharma SmPCTajPharmaQC
This document provides information on enalapril maleate/hydrochlorothiazide tablets produced by Taj Pharma for treating hypertension. It contains dosing instructions and lists side effects like dizziness and headache. Contraindications include hypersensitivity, severe renal impairment, pregnancy, and a history of angioedema from ACE inhibitors. Warnings include risks of hypotension, electrolyte imbalances, and renal impairment. The document provides details on administration, interactions, and special patient populations.
Digoxin Tablets USP 62.5mcg/125mcg/250mcg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Digoxin Dosage & Rx Info | Digoxin Uses, Side Effects Digoxin : Indications, Side Effects, Warnings, Digoxin -Drug Information –Taj Pharma, Digoxin dose Taj pharmaceuticals Digoxin interactions, Taj Pharmaceutical Digoxin contraindications, Digoxin price, Digoxin Taj Pharma Digoxin SmPC-Taj Pharma Stay connected to all updated on Digoxin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Digoxin Tablets USP 62.5mcg/125mcg/250mcg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Digoxin Dosage & Rx Info | Digoxin Uses, Side Effects Digoxin : Indications, Side Effects, Warnings, Digoxin -Drug Information –Taj Pharma, Digoxin dose Taj pharmaceuticals Digoxin interactions, Taj Pharmaceutical Digoxin contraindications, Digoxin price, Digoxin Taj Pharma Digoxin SmPC-Taj Pharma Stay connected to all updated on Digoxin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Ciprofloxacin Tablets USP 250mg/500mg/750mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Ciprofloxacin Dosage & Rx Info | Ciprofloxacin Uses, Side Effects Ciprofloxacin : Indications, Side Effects, Warnings, Ciprofloxacin -Drug Information –Taj Pharma, Ciprofloxacin dose Taj pharmaceuticals Ciprofloxacin interactions, Taj Pharmaceutical Ciprofloxacin contraindications, Ciprofloxacin price, Ciprofloxacin Taj Pharma Ciprofloxacin SmPC-Taj Pharma Stay connected to all updated on Ciprofloxacin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Azithromycin Tablets USP 250mg/500mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Azithromycin Dosage & Rx Info | Azithromycin Uses, Side Effects Azithromycin: Indications, Side Effects, Warnings, Azithromycin -Drug Information –Taj Pharma, Azithromycin dose Taj pharmaceuticals Azithromycin interactions, Taj Pharmaceutical Azithromycin contraindications, Azithromycin price, Azithromycin Taj Pharma Azithromycin SmPC-Taj Pharma Stay connected to all updated on Azithromycin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Atomoxetine Capsules USP Taj Pharma SmPCTajPharmaQC
Atomoxetine Capsules USP 10mg/18mg/25mg/40mg/60mg/80mg/100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Atomoxetine Dosage & Rx Info | Atomoxetine Uses, Side Effects Atomoxetine: Indications, Side Effects, Warnings, Atomoxetine -Drug Information –Taj Pharma, Atomoxetine dose Taj pharmaceuticals Atomoxetine interactions, Taj Pharmaceutical Atomoxetine contraindications, Atomoxetine price, Atomoxetine Taj Pharma Atomoxetine SmPC-Taj Pharma Stay connected to all updated on Atomoxetine Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Vildagliptin Tablets 50mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Vildagliptin Dosage & Rx Info | Vildagliptin Uses, Side Effects Vildagliptin: Indications, Side Effects, Warnings, Vildagliptin -Drug Information –Taj Pharma, Vildagliptin dose Taj pharmaceuticals Vildagliptin interactions, Taj Pharmaceutical Vildagliptin contraindications, Vildagliptin price, Vildagliptin Taj Pharma Vildagliptin SmPC-Taj Pharma Stay connected to all updated on Vildagliptin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Theophylline Extended-Release Tablets 100mg, 200mg, 300mg, 400mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Theophylline Dosage & Rx Info | Theophylline Uses, Side Effects Theophylline: Indications, Side Effects, Warnings, Theophylline -Drug Information –Taj Pharma, Theophylline dose Taj pharmaceuticals Theophylline interactions, Taj Pharmaceutical Theophylline contraindications, Theophylline price, Theophylline Taj Pharma Theophylline SmPC-Taj Pharma Stay connected to all updated on Theophylline Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Sofosbuvir/Velpatasvir Tablets Taj Pharma SmPCTajPharmaQC
Sofosbuvir/Velpatasvir Tablets 400mg/100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Sofosbuvir/Velpatasvir Dosage & Rx Info | Sofosbuvir/Velpatasvir Uses, Side Effects Sofosbuvir/Velpatasvir: Indications, Side Effects, Warnings, Sofosbuvir/Velpatasvir -Drug Information –Taj Pharma, Sofosbuvir/Velpatasvir dose Taj pharmaceuticals Sofosbuvir/Velpatasvir interactions, Taj Pharmaceutical Sofosbuvir/Velpatasvir contraindications, Sofosbuvir/Velpatasvir price, Sofosbuvir/Velpatasvir Taj Pharma Sofosbuvir/Velpatasvir SmPC-Taj Pharma Stay connected to all updated on Sofosbuvir/Velpatasvir Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
This document provides information on Sofosbuvir Tablets 400mg by Taj Pharma, including its uses, dosage, administration instructions, and safety information. Key details include:
- Sofosbuvir is used in combination with other medications to treat chronic hepatitis C in adults and adolescents aged 12-18.
- The recommended dosage for adults is one 400mg tablet taken orally once daily with food. Dosage recommendations are also provided for adolescents aged 12-18.
- Special populations like renal impairment patients may use Sofosbuvir but dosage adjustments are not required, though safety data is limited in severe renal impairment. No dose adjustments are needed for hepatic impairment.
- Sofosbuvir should not be
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.
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
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
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.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler Community Health Nursing A Canadian Perspective, 5th Edition TEST BANK by Stamler Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Study Guide Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Studocu Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Course Hero Community Health Nursing A Canadian Perspective, 5th Edition Answers Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Course hero Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Studocu Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Study Guide Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Ebook Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Questions Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Studocu Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Stuvia
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Dehradun #ℂall #gIRLS Oyo Hotel 8107221448 #ℂall #gIRL in Dehradun
Gemcitabine for Injection USP Taj Pharma SmPC
1. Gemcitabine 200mg, 100 0mg Powde rfo rsolution forInjec tion TajPha rma : Uses, Side Effects, Inte ractions, Pictu res, Warnings, Gemcitabine Dosage & Rx Info | Gemcitabine Uses, Side Effects - An ticancer, Gemcitabine : In dications, Side Effec ts, Warnings, Gemcitabine - Drug In forma tion - Taj Pharma, Gemcitabine dose Taj pha rmaceuticals Gemcitabine in teracti ons, Taj Pharmaceu tical Gemcitabine cont raindicatio ns, Gemcitabine price, Gemcitabi ne TajPharma An ticancer SmPC - TajPharma Stay connecte d to all upda ted on Gemcita bine Taj Pha rmaceuticals Taj pharmaceuticals Mum bai. Patien t Inf ormati on Leaflets, SmPC.
Rx
Gemcitabine USP powder for
solution for
injection 200mg/1000mg
1. NAME OF THE MEDICINAL
PRODUCT
Gemcitabine USP 200mg powder for solution
for injection Taj Pharma
Gemcitabine USP 1000mg powder for solution
for injection Taj Pharma
2. QUALITATIVE AND
QUANTITATIVE COMPOSITION
a) Gemcitabine USP 200 mg powder for
solution for injection Taj Pharma
Each sterile lyophilized vial contains
Gemcitabine hydrochloride USP
Equivalent to Gemitabine 200mg
Mannitol USP 1000mg
Sodium Acetate USP 62.5mg
Sodium Hydroxide USPNF q.s.
Hydrochloric Acid USPNF q.s.
b) Gemcitabine USP 1000 mg powder for
solution for injection Taj Pharma
Each sterile lyophilized vial contains
Gemcitabine hydrochloride USP
Equivalent to Gemitabine 1000mg
Mannitol USP 1000mg
Sodium Acetate USP 62.5mg
Sodium Hydroxide USPNF q.s.
Hydrochloric Acid USPNF q.s.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white lyophilized cake.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Gemcitabine is indicated for the treatment of
locally advanced or metastatic bladder cancer in
combination with cisplatin.
Gemcitabine is indicated for treatment of
patients with locally advanced or metastatic
adenocarcinoma of the pancreas.
Gemcitabine, in combination with cisplatin is
indicated as first line treatment of patients with
locally advanced or metastatic non-small cell
lung cancer (NSCLC). Gemcitabine
monotherapy can be considered in elderly
patients or those with performance status 2.
Gemcitabine is indicated for the treatment of
patients with locally advanced or metastatic
epithelial ovarian carcinoma, in combination
with carboplatin, in patients with relapsed
disease following a recurrence-free interval of at
least 6 months after platinum-based, first-line
therapy.
Gemcitabine, in combination with paclitaxel, is
indicated for the treatment of patients with
unresectable, locally recurrent or metastatic
breast cancer who have relapsed following
adjuvant/neoadjuvant chemotherapy. Prior
chemotherapy should have included an
anthracycline unless clinically contraindicated.
4.2 Posology and method of administration
Gemcitabine should only be prescribed by a
physician qualified in the use of anti-cancer
chemotherapy.
Posology
Bladder cancer
Combination use
The recommended dose for gemcitabine is 1000
mg/m2
, given by 30-minute infusion. The dose
should be given on Days 1, 8 and 15 of each 28-
day cycle in combination with cisplatin.
Cisplatin is given at a recommended dose of 70
mg/m2
on Day 1 following gemcitabine or day 2
of each 28-day cycle. This 4-week cycle is then
repeated. Dosage reduction with each cycle or
within a cycle may be applied based upon the
grade of toxicity experienced by the patient.
Pancreatic cancer
The recommended dose of gemcitabine is 1000
mg/m2
, given by 30-minute intravenous
infusion. This should be repeated once weekly
for up to 7 weeks followed by a week of rest.
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Subsequent cycles should consist of injections
once weekly for 3 consecutive weeks out of
every 4 weeks. Dosage reduction with each
cycle or within a cycle may be applied based
upon the grade of toxicity experienced by the
patient.
Non small cell lung cancer
Monotherapy
The recommended dose of gemcitabine is 1000
mg/m2
, given by 30-minute intravenous
infusion. This should be repeated once weekly
for 3 weeks, followed by a 1-week rest period.
This 4-week cycle is then repeated. Dosage
reduction with each cycle or within a cycle may
be applied based upon the grade of toxicity
experienced by the patient.
Combination use
The recommended dose for gemcitabine is 1250
mg/m2
body surface area given as a 30-minute
intravenous infusion on Day 1 and 8 of the
treatment cycle (21 days). Dosage reduction
with each cycle or within a cycle may be applied
based upon the grade of toxicity experienced by
the patient. Cisplatin has been used at doses
between 75-100 mg/m2
once every 3 weeks.
Breast cancer
Combination use
Gemcitabine in combination with paclitaxel is
recommended using paclitaxel (175 mg/m2
)
administered on Day 1 over approximately 3-
hours as an intravenous infusion, followed by
gemcitabine (1250 mg/m2
) as a 30-minute
intravenous infusion on Days 1 and 8 of each
21-day cycle. Dose reduction with each cycle or
within a cycle may be applied based upon the
grade of toxicity experienced by the patient.
Patients should have an absolute granulocyte
count of at least 1,500 (x 106
/l) prior to initiation
of gemcitabine + paclitaxel combination.
Ovarian cancer
Combination use
Gemcitabine in combination with carboplatin is
recommended using gemcitabine 1000
mg/m2
administered on Days 1 and 8 of each 21-
day cycle as a 30-minute intravenous infusion.
After gemcitabine, carboplatin will be given on
Day 1 consistent with a target Area under curve
(AUC) of 4.0 mg/ml-min. Dosage reduction
with each cycle or within a cycle may be applied
based upon the grade of toxicity experienced by
the patient.
Monitoring for toxicity and dose modification
due to toxicity
Dose modification due to non haematological
toxicity
Periodic physical examination and checks of
renal and hepatic function should be made to
detect non-haematological toxicity. Dosage
reduction with each cycle or within a cycle may
be applied based upon the grade of toxicity
experienced by the patient. In general, for severe
(Grade 3 or 4) non-haematological toxicity,
except nausea/vomiting, therapy with
gemcitabine should be withheld or decreased
depending on the judgement of the treating
physician. Doses should be withheld until
toxicity has resolved in the opinion of the
physician.
For cisplatin, carboplatin, and paclitaxel dosage
adjustment in combination therapy, please refer
to the corresponding Summary of Product
Characteristics.
Dose modification due to haematological
toxicity
Initiation of a cycle
For all indications, the patient must be
monitored before each dose for platelet and
granulocyte counts. Patients should have an
absolute granulocyte count of at least 1,500 (x
106
/l) and platelet count of 100,000 (x 106
/l)
prior to the initiation of a cycle.
Within a cycle
Dose modifications of gemcitabine within a
cycle should be performed according to the
following tables:
Dose modification of gemcitabine within a
cycle for bladder cancer, NSCLC and
pancreatic cancer, given in monotherapy or
in combination with cisplatin
Absolute Platelet Percentage
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granulocyte count
(x 106
/l)
count
(x 106
/l)
of standard
dose of
Gemcitabine
(%)
> 1,000 and > 100,000 100
500-1,000 or 50,000-
100,000
75
<500 or < 50,000 Omit dose *
* Treatment omitted will not be re-instated
within a cycle before the absolute granulocyte
count reaches at least 500 (x106
/l) and the
platelet count reaches 50,000 (x106
/l).
Dose modification of gemcitabine within a
cycle for breast cancer, given in combination
with paclitaxel
Absolute
granulocyte count
(x 106
/l)
Platelet
count
(x 106
/l)
Percentage
of standard
dose of
Gemcitabine
(%)
> 1,200 and >75,000 100
1,000-<l,200 or 50,000-
75,000
75
700-<l,000 and ≥ 50,000 50
<700 or <50,000 Omit dose*
* Treatment omitted will not be re-instated
within a cycle. Treatment will start on day 1 of
the next cycle once the absolute granulocyte
count reaches at least 1,500 (x106
/l) and the
platelet count reaches 100,000 (x106
/l).
Dose modification of gemcitabine within a
cycle for ovarian cancer, given in
combination with carboplatin
Absolute
granulocyte count
(x 106
/l)
Platelet
count
(x 106
/l)
Percentage
of standard
dose of
Gemcitabine
(%)
> 1,500 and ≥ 100,000 100
1000-1,500 or 75,000-
100,000
50
<1000 or < 75,000 Omit dose*
* Treatment omitted will not be re-instated
within a cycle. Treatment will start on day 1 of
the next cycle once the absolute granulocyte
count reaches at least 1,500 (x106
/l) and the
platelet count reaches 100,000 (x106
/l).
Dose modifications due to haematological
toxicity in subsequent cycles, for all indications
The gemcitabine dose should be reduced to 75%
of the original cycle initiation dose, in the case
of the following haematological toxicities:
• Absolute granulocyte count < 500 x 106
/l for
more than 5 days
• Absolute granulocyte count < 100 x 106
/l for
more than 3 days
• Febrile neutropaenia
• Platelets < 25,000 x106
/l
• Cycle delay of more than 1 week due to
toxicity
Method of administration
Gemcitabine is tolerated well during infusion
and may be administered ambulant. If
extravasation occurs, generally the infusion must
be stopped immediately and started again in
another blood vessel. The patient should be
monitored carefully after the administration.
For instructions on reconstitution of the
medicinal product before administration, see
section 6.6.
Special populations
Patients with renal or hepatic impairment
Gemcitabine should be used with caution in
patients with hepatic or renal impairment as
there is insufficient information from clinical
studies to allow for clear dose recommendations
for these patient populations (see sections 4.4
and 5.2).
Older people (> 65 years)
Gemcitabine has been well tolerated in patients
over the age of 65. There is no evidence to
suggest that dose adjustments, other than those
already recommended for all patients, are
necessary in older people (see section 5.2).
Paediatric population (< 18 years)
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Gemcitabine is not recommended for use in
children under 18 years of age due to
insufficient data on safety and efficacy.
4.3 Contraindications
Hypersensitivity to the active substance or to
any of the excipients listed in section 6.1.
Breast-feeding (see section 4.6).
4.4 Special warnings and precautions for use
Prolongation of the infusion time and increased
dosing frequency have been shown to increase
toxicity.
Haematological toxicity
Gemcitabine can suppress bone marrow function
as manifested by leucopaenia,
thrombocytopaenia and anaemia.
Patients receiving gemcitabine should be
monitored prior to each dose for platelet,
leucocyte and granulocyte counts. Suspension or
modification of therapy should be considered
when drug-induced bone marrow depression is
detected (see section 4.2). However,
myelosuppression is short lived and usually does
not result in dose reduction and rarely in
discontinuation.
Peripheral blood counts may continue to
deteriorate after gemcitabine administration has
been stopped. In patients with impaired bone
marrow function, the treatment should be started
with caution.
As with other cytotoxic treatments, the risk of
cumulative bone-marrow suppression must be
considered when gemcitabine treatment is given
together with other chemotherapy.
Hepatic and renal impairment
Gemcitabine should be used with caution in
patients with hepatic or renal function
impairment as there is insufficient information
from clinical studies to allow clear dose
recommendation for this patient population (see
section 4.2).
Administration of gemcitabine in patients with
concurrent liver metastases or a pre-existing
medical history of hepatitis, alcoholism or liver
cirrhosis may lead to exacerbation of the
underlying hepatic impairment.
Laboratory evaluation of renal and hepatic
function (including virological tests) should be
performed periodically.
Concomitant radiotherapy
Concomitant radiotherapy (given together or ≤ 7
days apart): Toxicity has been reported (see
section 4.5 for details and recommendations for
use).
Live vaccinations
Yellow fever vaccine and other live attenuated
vaccines are not recommended in patients
treated with gemcitabine (see section 4.5).
Posterior reversible encephalopathy syndrome
Reports of posterior reversible encephalopathy
syndrome (PRES) with potentially severe
consequences have been reported in patients
receiving gemcitabine as single agent or in
combination with other chemotherapeutic
agents. Acute hypertension and seizure activity
were reported in most gemcitabine patients
experiencing PRES, but other symptoms such as
headache, lethargy, confusion and blindness
could also be present. Diagnosis is optimally
confirmed by magnetic resonance imaging
(MRI). PRES was typically reversible with
appropriate supportive measures. Gemcitabine
should be permanently discontinued and
supportive measures implemented, including
blood pressure control and anti-seizure therapy,
if PRES develops during therapy.
Cardiovascular
Due to the risk of cardiac and/or vascular
disorders with gemcitabine, particular caution
must be exercised with patients presenting a
history of cardiovascular events.
Capillary leak syndrome
Capillary leak syndrome has been reported in
patients receiving gemcitabine as single agent or
in combination with other chemotherapeutic
agents (see section 4.8). The condition is usually
treatable if recognised early and managed
appropriately, but fatal cases have been reported.
The condition involves systemic capillary
hyperpermeability during which fluid and
proteins from the intravascular space leak into
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the interstitium. The clinical features include
generalised oedema, weight gain,
hypoalbuminaemia, severe hypotension, acute
renal impairment and pulmonary oedema.
Gemcitabine should be discontinued and
supportive measures implemented if capillary
leak syndrome develops during therapy.
Capillary leak syndrome can occur in later
cycles and has been associated in the literature
with adult respiratory distress syndrome.
Pulmonary
Pulmonary effects, sometimes severe (such as
pulmonary oedema, interstitial pneumonitis or
adult respiratory distress syndrome (ARDS))
have been reported in association with
gemcitabine therapy.
If such effects develop, consideration should be
made to discontinuing gemcitabine therapy.
Early use of supportive care measure may help
ameliorate the condition.
Renal
Haemolytic uraemic syndrome
Clinical findings consistent with the haemolytic
uraemic syndrome (HUS) were rarely reported
(post- marketing data) in patients receiving
gemcitabine (see section 4.8). HUS is a
potentially life-threatening disorder.
Gemcitabine should be discontinued at the first
signs of any evidence of microangiopathic
haemolytic anaemia, such as rapidly falling
haemoglobin with concomitant
thrombocytopaenia, elevation of serum bilirubin,
serum creatinine, blood urea nitrogen, or LDH.
Renal failure may not be reversible with
discontinuation of therapy and dialysis may be
required.
Fertility
In fertility studies gemcitabine caused
hypospermatogenesis in male mice (see section
5.3). Therefore, men being treated with
gemcitabine are advised not to father a child
during and up to 6 months after treatment and to
seek further advice regarding cryoconservation
of sperm prior to treatment because of the
possibility of infertility due to therapy with
gemcitabine (see section 4.6).
Sodium
This medicine contains less than 1 mmol sodium
(23 mg) per vial, that is to say essentially
'sodium-free'.
4.5 Interaction with other medicinal products
and other forms of interaction
No specific interaction studies have been
performed (see section 5.2)
Radiotherapy
Concurrent (given together or ≤ 7 days apart) -
Toxicity associated with this multimodality
therapy is dependent on many different factors,
including dose of gemcitabine, frequency of
gemcitabine administration, dose of radiation,
radiotherapy planning technique, the target
tissue, and target volume. Pre-clinical and
clinical studies have shown that gemcitabine has
radiosensitising activity. In a single trial, where
gemcitabine at a dose of 1,000 mg/m2
was
administered concurrently for up to 6
consecutive weeks with therapeutic thoracic
radiation to patients with non-small cell lung
cancer, significant toxicity in the form of severe,
and potentially life threatening mucositis,
especially oesophagitis, and pneumonitis was
observed, particularly in patients receiving large
volumes of radiotherapy [median treatment
volumes 4,795 cm3
]. Studies done subsequently
have suggested that it is feasible to administer
gemcitabine at lower doses with concurrent
radiotherapy with predictable toxicity, such as a
phase II study in non-small cell lung cancer,
where thoracic radiation doses of 66 Gy were
applied concomitantly with an administration
with gemcitabine (600 mg/m2
, four times) and
cisplatin (80 mg/m2
twice) during 6 weeks. The
optimum regimen for safe administration of
gemcitabine with therapeutic doses of radiation
has not yet been determined in all tumour types.
Non-concurrent (given >7 days apart)- Analysis
of the data does not indicate any enhanced
toxicity when gemcitabine is administered more
than 7 days before or after radiation, other than
radiation recall. Data suggest that gemcitabine
can be started after the acute effects of radiation
have resolved or at least one week after
radiation.
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Radiation injury has been reported on targeted
tissues (e.g. oesophagitis, colitis, and
pneumonitis) in association with both concurrent
and non-concurrent use of gemcitabine.
Others
Yellow fever and other live attenuated vaccines
are not recommended due to the risk of
systemic, possibly fatal, disease, particularly in
immunosuppressed patients.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of
gemcitabine in pregnant women. Studies in
animals have shown reproductive toxicity (see
section 5.3). Based on results from animal
studies and the mechanism of action of
gemcitabine, this substance should not be used
during pregnancy unless clearly necessary.
Women should be advised not to become
pregnant during treatment with gemcitabine and
to warn their attending physician immediately,
should this occur after all.
Breast-feeding
It is not known whether gemcitabine is excreted
in human milk and adverse effects on the
suckling child cannot be excluded. Breast-
feeding must be discontinued during
gemcitabine therapy.
Fertility
In fertility studies gemcitabine caused
hypospermatogenesis in male mice (see section
5.3). Therefore, men being treated with
gemcitabine are advised not to father a child
during and up to 6 months after treatment and to
seek further advice regarding cryoconservation
of sperm prior to treatment because of the
possibility of infertility due to therapy with
gemcitabine.
4.7 Effects on ability to drive and use
machines
No studies on the effects on the ability to drive
and use machines have been performed.
However, gemcitabine has been reported to
cause mild to moderate somnolence, especially
in combination with alcohol consumption.
Patients should be cautioned against driving or
operating machinery until it is established that
they do not become somnolent.
4.8 Undesirable effects
The most commonly reported adverse drug
reactions associated with Gemcitabine treatment
include: nausea with or without vomiting, raised
liver transaminases (AST/ALT) and alkaline
phosphatase, reported in approximately 60% of
patients; proteinuria and haematuria reported in
approximately 50% patients; dyspnoea reported
in 10-40% of patients (highest incidence in lung
cancer patients); allergic skin rashes occur in
approximately 25% of patients and are
associated with itching in 10% of patients.
The frequency and severity of the adverse
reactions are affected by the dose, infusion rate
and intervals between doses (see section 4.4).
Dose-limiting adverse reactions are reductions in
thrombocyte, leucocyte and granulocyte counts
(see section 4.2).
Clinical trial data
Frequencies are defined as: Very common (≥
l/10), Common (≥ l/100 to <1/10), Uncommon
(≥ l/1000 to <1/100), Rare (≥ l/10,000 to
<1/1000), Very Rare (<1/10,000), Not known
(cannot be estimated from the available data).
The following table of undesirable effects and
frequencies is based on data from clinical trials.
Within each frequency grouping, undesirable
effects are presented in order of decreasing
seriousness.
System Organ
Class
Frequency grouping
Infections and
infestations
Common
• Infections
Not known
• Sepsis
Blood and
lymphatic system
disorders
Very common
• Leucopaenia (Neutropaenia
Grade 3 = 19.3%; Grade 4 =
6%).
Bone-marrow suppression is
usually mild to moderate and
mostly affects the
granulocyte count (see
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section 4.2 and 4.4)
• Thrombocytopaenia
• Anaemia
Common
• Febrile neutropaenia
Very rare
• Thrombocytosis
• Thrombotic
microangiopathy
Immune system
disorders
Very rare
• Anaphylactoid reaction
Metabolism and
nutrition disorders
Common
• Anorexia
Nervous system
disorders
Common
• Headache
• Insomnia
• Somnolence
Uncommon
• Cerebrovascular accident
Very rare
Posterior reversible
encephalopathy syndrome
(see section 4.4.)
Cardiac disorders Uncommon
• Arrhythmias,
predominantly
supraventricular in nature
• Heart failure
Rare
• Myocardial infarct
Vascular disorders Rare
• Clinical signs of peripheral
vasculitis and gangrene
• Hypotension
Very rare
• Capillary leak syndrome
(see section 4.4)
Respiratory,
thoracic and
mediastinal
disorders
Very common
• Dyspnoea -usually mild
and passes rapidly without
treatment
Common
• Cough
• Rhinitis
Uncommon
• Interstitial pneumonitis
(see section 4.4)
• Bronchospasm -usually
mild and transient but may
require parenteral treatment
Rare
• Pulmonary oedema
• Adult respiratory distress
syndrome (see section 4.4)
Gastrointestinal
disorders
Very common
• Vomiting
• Nausea
Common
• Diarrhoea
• Stomatitis and ulceration of
the mouth
• Constipation
Very rare
• Ischaemic colitis
Hepatobiliary
disorders
Very common
• Elevation of liver
transaminases (AST and
ALT) and alkaline
phosphatase
Common
• Increased bilirubin
Uncommon
• Serious hepatotoxicity,
including liver failure and
death
Rare
• Increased gamma-glutamyl
transferase (GGT)
Skin and
subcutaneous
tissue disorders
Very common
• Allergic skin rash
frequently associated with
pruritus
• Alopecia
Common
• Itching
• Sweating
Rare
• Severe skin reactions,
including desquamation and
bullous skin eruptions
• Ulceration
• Vesicle and sore formation
• Scaling
Very rare
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• Toxic epidermal necrolysis
• Stevens-Johnson Syndrome
Not known
• Pseudocellulitis
Musculoskeletal
and connective
tissue disorders
Common
• Back pain
• Myalgia
Renal and urinary
disorders
Very Common
• Haematuria
• Mild proteinuria
Uncommon
• Renal failure (see section
4.4)
• Haemolytic uraemic
syndrome (see section 4.4)
General disorders
and administration
site conditions
Very common
• Influenza-like symptoms -
the most common symptoms
are fever, headache, chills,
myalgia, asthenia and
anorexia. Cough, rhinitis,
malaise, perspiration and
sleeping difficulties have
also been reported.
• Oedema/peripheral
oedema-including facial
oedema. Oedema is usually
reversible after stopping
treatment
Common
• Fever
• Asthenia
• Chills
Rare
• Injection site reactions-
mainly mild in nature
Injury, poisoning,
and procedural
complications
Rare
• Radiation toxicity (see
section 4.5).
• Radiation recall
Combination use in breast cancer
The frequency of grade 3 and 4 haematological
toxicities, particularly neutropaenia, increases
when gemcitabine is used in combination with
paclitaxel. However, the increase in these
adverse reactions is not associated with an
increased incidence of infections or
haemorrhagic events. Fatigue and febrile
neutropaenia occur more frequently when
gemcitabine is used in combination with
paclitaxel. Fatigue, which is not associated with
anaemia, usually resolves after the first cycle.
Grade 3 and 4 Adverse Events
Paclitaxel versus gemcitabine plus paclitaxel
Number (%) of Patients
Paclitaxel
arm
(N=259)
Gemcitabine
plus
Paclitaxel arm
(N=262)
Grade
3
Grade
4
Grade
3
Grade
4
Laboratory
Anaemia 5 (1.9)1 (0.4)15
(5.7)
3 (1.1)
Thrombocytopaenia 0 0 14
(5.3)
1 (0.4)
Neutropaenia 11
(4.2)
17
(6.6)*
82
(31.3)
45
(17.2)*
Non-laboratory
Febrile
neutropaenia
3 (1.2)0 12
(4.6)
1 (0.4)
Fatigue 3 (1.2)1 (0.4)15
(5.7)
2 (0.8)
Diarrhoea 5 (1.9)0 8 (3.1)0
Motor neuropathy 2 (0.8)0 6 (2.3)1 (0.4)
Sensory neuropathy 9 (3.5)0 14
(5.3)
1 (0.4)
*Grade 4 neutropaenia lasting for more than 7
days occurred in 12.6% of patients in the
combination arm and 5.0% of patients in the
paclitaxel arm.
Combination use in bladder cancer
Grade 3 and 4 Adverse Events
MVAC versus Gemcitabine plus cisplatin
Number (%) of Patients
MVAC
(methotrexate,
vinblastine,
doxorubicin
and cisplatin)
arm (N=196)
Gemcitabine
plus cisplatin
arm (N=200)
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Grade
3
Grade
4
Grade
3
Grade
4
Laboratory
Anaemia 30
(16)
4 (2) 47
(24)
7 (4)
Thrombocytopaenia 15 (8) 25
(13)
57
(29)
57
(29)
Non-laboratory
Nausea and
vomiting
37
(19)
3 (2) 44
(22)
0 (0)
Diarrhoea 15 (8) 1 (1) 6 (3) 0 (0)
Infection 19
(10)
10 (5) 4 (2) 1 (1)
Stomatitis 34
(18)
8 (4) 2 (1) 0 (0)
Combination use in ovarian cancer
Grade 3 and 4 Adverse Events
Carboplatin versus Gemcitabine plus carboplatin
Number (%) of Patients
Carboplatin
arm
(N=174)
Gemcitabine
plus
carboplatin
arm
(N=175)
Grade
3
Grade
4
Grade
3
Grade
4
Laboratory
Anaemia 10
(5.7)
4 (2.3) 39
(22.3)
9 (5.1)
Neutropaenia 19
(10.9)
2 (1.1) 73
(41.7)
50
(28.6)
Thrombocytopaenia 18
(10.3)
2 (1.1) 53
(30.3)
8 (4.6)
Leucopaenia 11
(6.3)
1 (0.6) 84
(48.0)
9 (5.1)
Non-laboratory
Haemorrhage 0 (0.0) 0 (0.0) 3 (1.8) (0.0)
Febrile
neutropaenia
0 (0.0) 0 (0.0) 2 (1.1) (0.0)
Infection without
neutropaenia
0 (0) 0 (0.0) (0.0) 1 (0.6)
Sensory neuropathy was also more frequent in
the combination arm than with single agent
carboplatin
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is
important. It allows continued monitoring of the
benefit/risk balance of the medicinal product.
4.9 Overdose
There is no known antidote for overdose of
gemcitabine. Doses as high as 5700 mg/m2
have
been administered by intravenous infusion over
30-minutes every 2 weeks with clinically
acceptable toxicity. In the event of suspected
overdose, the patient should be monitored with
appropriate blood counts and receive supportive
therapy, as necessary.
5. PHARMACOLOGICAL
PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: pyrimidine
analogues.
Cytotoxic activity in cell cultures
Gemcitabine shows significant cytotoxic effects
against a variety of cultured murine and human
tumour cells. Its action is phase-specific such
that gemcitabine primarily kills cells that are
undergoing DNA synthesis (S-phase) and, under
certain circumstances, blocks the progression of
cells at the junction of the G1/S phase boundary.
In vitro, the cytotoxic effect of gemcitabine is
dependent on both concentration and time.
Antitumoral activity in preclinical models
In animal tumour models, antitumoural activity
of gemcitabine is schedule-dependent. When
gemcitabine is administered daily, high
mortality among the animals but minimal
antitumoural activity is observed. If, however,
gemcitabine is given every third or fourth day, it
can be administered in non-lethal doses with
substantial antitumoural activity against a broad
spectrum of mouse tumours.
Mechanism of action
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Cellular metabolism and mechanism of action:
Gemcitabine (dFdC), which is a pyrimidine
antimetabolite, is metabolised intracellularly by
nucleoside kinase to the active diphosphate
(dFdCDP) and triphosphate (dFdCTP)
nucleosides. The cytotoxic effect of gemcitabine
is due to inhibition of DNA synthesis by two
mechanisms of action by dFdCDP and dFdCTP.
First, dFdCDP inhibits ribonucleotide reductase,
which is uniquely responsible for catalysing the
reactions that produce deoxynucleoside
triphosphates (dCTP) for DNA synthesis.
Inhibition of this enzyme by dFdCDP reduces
the concentration of deoxynucleosides in general
and, in particular, dCTP. Second, dFdCTP
competes with dCTP for incorporation into
DNA (self-potentiation).
Likewise, a small amount of gemcitabine may
also be incorporated into RNA. Thus, the
reduced intracellular concentration of dCTP
potentiates the incorporation of dFdCTP into
DNA. DNA polymerase epsilon lacks the ability
to eliminate gemcitabine and to repair the
growing DNA strands. After gemcitabine is
incorporated into DNA, one additional
nucleotide is added to the growing DNA strands.
After this addition there is essentially a complete
inhibition in further DNA synthesis (masked
chain termination). After incorporation into
DNA, gemcitabine appears to induce the
programmed cell death process known as
apoptosis.
Clinical data
Bladder cancer
A randomised phase III study of 405 patients
with advanced or metastatic urothelial
transitional cell carcinoma showed no difference
between the two treatment arms,
gemcitabine/cisplatin versus
methotrexate/vinblastine/adriamycin/cisplatin
(MVAC), in terms of median survival (12.8 and
14.8 months respectively, p=0.547), time to
disease progression (7.4 and 7.6 months
respectively, p=0.842) and response rate (49.4%
and 45.7% respectively, p=0.512). However, the
combination of gemcitabine and cisplatin had a
better toxicity profile than MVAC.
Pancreatic cancer
In a randomised phase III study of 126 patients
with advanced or metastatic pancreatic cancer,
gemcitabine showed a statistically significant
higher clinical benefit response rate than 5-
fluorouracil (23.8% and 4.8% respectively,
p=0.0022). Also, a statistically significant
prolongation of the time to progression from 0.9
to 2.3 months (log-rank p<0.0002) and a
statistically significant prolongation of median
survival from 4.4 to 5.7 months (log-rank
p<0.0024) was observed in patients treated with
gemcitabine compared to patients treated with 5-
fluorouracil.
Non small cell lung cancer
In a randomised phase III study of 522 patients
with inoperable, locally advanced or metastatic
NSCLC, gemcitabine in combination with
cisplatin showed a statistically significant higher
response rate than cisplatin alone (31.0% and
12.0%, respectively, p<0.0001). A statistically
significant prolongation of the time to
progression, from 3.7 to 5.6 months (log-rank
p<0.0012) and a statistically significant
prolongation of median survival from 7.6
months to 9.1 months (log-rank p<0.004) was
observed in patients treated with
gemcitabine/cisplatin compared to patients
treated with cisplatin.
In another randomised phase III study of 135
patients with stage IIIB or IV NSCLC, a
combination of gemcitabine and cisplatin
showed a statistically significant higher response
rate than a combination of cisplatin and
etoposide (40.6% and 21.2%, respectively,
p=0.025). A statistically significant prolongation
of the time to progression, from 4.3 to 6.9
months (p=0.014) was observed in patients
treated with gemcitabine/cisplatin compared to
patients treated with etoposide/cisplatin.
In both studies it was found that tolerability was
similar in the two treatment arms.
Ovarian carcinoma
In a randomised phase III study, 356 patients
with advanced epithelial ovarian carcinoma who
had relapsed at least 6 months after completing
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platinum based therapy were randomised to
therapy with gemcitabine and carboplatin
(GCb), or carboplatin (Cb). A statistically
significant prolongation of the time to
progression of disease, from 5.8 to 8.6 months
(log-rank p= 0.0038) was observed in the
patients treated with GCb compared to patients
treated with Cb. Differences in response rate of
47.2% in the GCb arm versus 30.9% in the Cb
arm (p=0.0016) and median survival 18 months
(GCb) versus 17.3 (Cb) (p=0.73) favoured the
GCb arm.
Breast cancer
In a randomised phase III study of 529 patients
with inoperable, locally recurrent or metastatic
breast cancer with relapse after
adjuvant/neoadjuvant chemotherapy,
gemcitabine in combination with paclitaxel
showed a statistically significant prolongation of
time to documented disease progression from
3.98 to 6.14 months (log-rank p=0.0002) in
patients treated with gemcitabine/paclitaxel
compared to patients treated with paclitaxel.
After 377 deaths, the overall survival was 18.6
months versus 15.8 months (log rank p=0.0489,
HR 0.82) in patients treated with
gemcitabine/paclitaxel compared to patients
treated with paclitaxel and the overall response
rate was 41.4% and 26.2% respectively (p=
0.0002).
5.2 Pharmacokinetic properties
The pharmacokinetics of gemcitabine have been
examined in 353 patients in seven studies. The
121 women and 232 men ranged in age from 29
to 79 years. Of these patients, approximately
45% had non-small cell lung cancer and 35%
were diagnosed with pancreatic cancer. The
following pharmacokinetic parameters were
obtained for doses ranging from 500 to 2,592
mg/m2
that were infused from 0.4 to 1.2 hours.
Peak plasma concentrations (obtained within 5
minutes of the end of the infusion) were 3.2 to
45.5 µg/ml. Plasma concentrations of the parent
compound following a dose of 1,000 mg/m2
/30-
minutes are greater than 5 µg/ml for
approximately 30-minutes after the end of the
infusion, and greater than 0.4 µg/ml for an
additional hour.
Distribution
The volume of distribution of the central
compartment was 12.4 l/m2
for women and 17.5
l/m2
for men (inter-individual variability was
91.9%). The volume of distribution of the
peripheral compartment was 47.4 l/m2
. The
volume of the peripheral compartment was not
sensitive to gender.
The plasma protein binding was considered to be
negligible.
Half-life: This ranged from 42 to 94 minutes
depending on age and gender. For the
recommended dosing schedule, gemcitabine
elimination should be virtually complete within
5 to 11 hours of the start of the infusion.
Gemcitabine does not accumulate when
administered once weekly.
Metabolism
Gemcitabine is rapidly metabolised by cytidine
deaminase in the liver, kidney, blood and other
tissues. Intracellular metabolism of gemcitabine
produces the gemcitabine mono, di and
triphosphates (dFdCMP, dFdCDP and dFdCTP)
of which dFdCDP and dFdCTP are considered
active. These intracellular metabolites have not
been detected in plasma or urine. The primary
metabolite, 2'-deoxy-2', 2'-difluorouridine
(dFdU), is not active and is found in plasma and
urine.
Excretion
Systemic clearance ranged from 29.2 l/hr/m2
to
92.2 /hr/m2
depending on gender and age (inter-
individual variability was 52.2%). Clearance for
women is approximately 25% lower than the
values for men. Although rapid, clearance for
both men and women appears to decrease with
age. For the recommended gemcitabine dose of
1000 mg/m2
given as a 30-minute infusion,
lower clearance values for women and men
should not necessitate a decrease in the
gemcitabine dose. Urinary excretion: Less than
10% is excreted as unchanged drug. Renal
clearance was 2 to 7 l/hr/m2
.
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During the week following administration, 92 to
98% of the dose of gemcitabine administered is
recovered, 99% in the urine, mainly in the form
of dFdU and 1% of the dose is excreted in
faeces.
dFdCTP kinetics
This metabolite can be found in peripheral blood
mononuclear cells and the information below
refers to these cells. Intracellular concentrations
increase in proportion to gemcitabine doses of
35-350 mg/m2
/30-minutes, which give steady
state concentrations of 0.4-5 µg/ml. At
gemcitabine plasma concentrations above 5
µg/ml, dFdCTP levels do not increase,
suggesting that the formation is saturable in
these cells.
Half-life of terminal elimination: 0.7-12 hours.
dFdU kinetics
Peak plasma concentrations (3-15 minutes after
end of 30-minute infusion, 1000 mg/m2
): 28-52
µg/ml.
Trough concentration following once weekly
dosing: 0.07-1.12 µg/ml, with no apparent
accumulation.
Triphasic plasma concentration versus time
curve, mean half-life of terminal phase - 65
hours (range 33-84 hr).
Formation of dFdU from parent compound:
91%-98%.
Mean volume of distribution of central
compartment: 18 l/m2
(range 11-22 l/m2
).
Mean steady state volume of distribution (Vss):
150 l/m2
(range 96-228 l/m2
).
Tissue distribution: Extensive.
Mean apparent clearance: 2.5 l/hr/m2
(range 1-4
l/hr/m2
).
Urinary excretion: All.
Gemcitabine and paclitaxel combination therapy
Combination therapy did not alter the
pharmacokinetics of either gemcitabine or
paclitaxel.
Gemcitabine and carboplatin combination
therapy
When given in combination with carboplatin the
pharmacokinetics of gemcitabine were not
altered
Renal impairment
Mild to moderate renal insufficiency (GFR from
30 ml/min to 80 ml/min) has no consistent,
significant effect on gemcitabine
pharmacokinetics.
5.3 Preclinical safety data
In repeat-dose studies of up to 6 months in
duration in mice and dogs, the principal finding
was schedule and dose-dependent
haematopoietic suppression which was
reversible.
Gemcitabine is mutagenic in an in vitro mutation
test and an in vivo bone marrow micronucleus
test. Long term animal studies evaluating the
carcinogenic potential have not been performed.
In fertility studies, gemcitabine caused
reversible hypospermatogenesis in male mice.
No effect on the fertility of females has been
detected.
Evaluation of experimental animal studies has
shown reproductive toxicity e.g. birth defects
and other effects on the development of the
embryo or foetus, the course of gestation or peri-
and postnatal development.
6. PHARMACEUTICAL
PARTICULARS
6.1 List of excipients
The other ingredients are: Mannitol USP,
Sodium Acetate USP, Sodium Hydroxide
USPNF, Hydrochloric Acid USPNF.
6.2 Incompatibilities
This medicinal product must not be mixed with
other medicinal products except those mentioned
in section 6.6.
6.3 Shelf life
As packaged for sale:
24 months
After reconstitution:
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Chemical and physical in-use stability has been
demonstrated for 24 hours at 30°C.
From a microbiological point of view, the
product should be used immediately. If not used
immediately, in-use storage times and conditions
prior to use are the responsibility of the user and
would normally not be longer than 24 hours at
30°C.
Reconstituted gemcitabine should not be
refrigerated, as this results in crystallisation.
6.4 Special precautions for storage
This medicinal product does not require any
special storage conditions.
For storage conditions after reconstitution of the
medicinal product, see section 6.3.
6.5 Nature and contents of container
Glass colourless type-I tubular glass vial with
bromobutyl rubber stopper.
Pack size: 1 vial of 10ml or 1 vial of 50ml.
6.6 Special precautions for disposal and other
handling
Reconstituting the solution
Physiological saline solution without
preservative agents is the only diluent approved
for reconstituting gemcitabine solution for
infusion. Although incompatibilities have not
been observed, mixing gemcitabine with other
substances during reconstitution or
administration is not recommended. Following
dilution, the upper gemcitabine concentration
limit is 38 mg/ml. Dilution to concentrations
above 38 mg/ml may result in incomplete
dissolution and should be avoided.
To reconstitute the product, 5 ml (min.) or 25 ml
(min.) of 0.9% physiological saline solution is
added to the 200 mg vial or 1 g vial, respectively
(both yielding a final concentration of 38 mg/ml
and a displacements volume of 0.26 ml or 1.3 ml
respectively). During reconstitution of the
solution, the diluent should be added slowly
down the side of the vial. Then, shake to
dissolve. Further dilution with 0.9%
physiological saline solution is possible.
After dilution, the solution for infusion should
be inspected visually for particulate matter and
discolouration. Only clear solutions practically
free from suspended particles should be used.
Handling
Standard precautions for reconstituting cytotoxic
agents must be observed. The preparation of
injectable solutions of cytotoxic agents must be
carried out by trained specialist personnel with
knowledge of the medicines used, in conditions
that guarantee the protection of the environment
and, particular, the protection of personnel
handling the medicines. It requires a preparation
area reserved for this purpose. It is forbidden to
smoke, eat or drink in this area.
Personnel must be provided with appropriate
handling materials, notably long sleeved gowns,
protection masks, caps, protective goggles,
sterile single-use gloves, protective covers for
the work area and collection bags for waste.
Cytotoxic preparations should not be handled by
pregnant staff.
If the product is allowed to come into contact
with the eyes, severe irritation may result. In
such an event, the eyes should be washed
thoroughly and immediately. Consult a doctor if
irritation persists. If the solution should come
into contact with skin, rinse the affected area
thoroughly with water. Excreta and vomit must
be handled with care.
Disposal
All items used for preparation, administration or
otherwise coming into contact with gemcitabine
should undergo disposal according to hospital
standard procedures applicable to cytotoxic
agents with due regard to current laws related to
the disposal of hazardous waste.
7.Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
at SURVEY NO.188/1 TO 189/1,190/1 TO 4,
ATHIYAWAD, DABHEL, DAMAN- 396210
(INDIA).