The document summarizes information from an Egyptian Pharmacovigilance newsletter. It discusses two case reports received by the Cairo regional center. The first case involved a 92-year-old female patient who developed peripheral limb ischemia and cyanosis after being given Noradrenaline to treat hypotension. The second case involved high sodium levels being detected in blood samples withdrawn from intravenous devices that were flushed with Heparin sodium solution. The document provides background information on Noradrenaline and Heparin, details on the two cases, and recommendations for healthcare professionals.
This document discusses anesthesia for patients on anticoagulant therapy. It provides an overview of hemostasis and the coagulation cascade involving platelets and clotting factors. Key laboratory tests for assessing coagulation are described, including prothrombin time (PT), international normalized ratio (INR), partial thromboplastin time (PTT), thrombin time, and thromboelastography. Common anticoagulants like heparin and warfarin are explained in terms of their mechanisms and monitoring. Warfarin inhibits vitamin K dependent clotting factors and its effect is monitored by PT/INR, while heparin acts by binding to antithrombin.
Anesthesia in patients on anti coagulantsNavin Jain
This document discusses anesthesia considerations for patients on various anticoagulant medications. It reviews the coagulation cascade and indications for anticoagulation therapy. Common anticoagulants are described including antiplatelet drugs, oral anticoagulants like warfarin, heparins, and newer agents. Guidelines are provided for managing patients on these medications in the perioperative period, including recommendations for stopping medications prior to procedures and resuming them postoperatively. Specific guidance is given for neuraxial anesthesia in anticoagulated patients.
The document provides guidelines from the American Society of Regional Anesthesia (ASRA) on placing and removing epidural catheters in patients taking anticoagulant and antiplatelet drugs. It lists recommended minimum times to wait after the last dose of various medications before catheter placement and removal, as well as when to restart anticoagulation therapy after removal. The medications are grouped into heparins, low molecular weight heparins, factor Xa and direct thrombin inhibitors, antiplatelet agents, fibrinolytics, and glycoprotein IIb/IIIa inhibitors. For each group, it provides the drug names and recommended waiting times.
Anticoagulants, antiplatelet drugs and anesthesiaRajesh Munigial
It is a presentation on anticoagulants and antiplatelets in anesthesia , starting from basis of coagulation , its tests and dugs and anesthetic implications
Based on latest ASRA (AMERICAN SOCIETY OF REGIONAL ANESTHESIA GUIDELINES)
This document discusses regional anesthesia and antithrombotic drugs. It notes that vertebral canal hematoma is a rare but potentially devastating complication of central neuraxial blockade, especially for patients taking anticoagulant or antithrombotic drugs. It provides guidance on timing the administration of various antithrombotic drugs like aspirin, clopidogrel, enoxaparin and warfarin in relation to regional anesthesia to minimize bleeding risks. It also discusses risk factors and considerations for different types of regional techniques and antithrombotic drugs.
This document discusses anticoagulation and neuraxial anesthesia/analgesia. It provides an overview of case reports of epidural hematomas occurring with the anticoagulant Lovenox. It then reviews indications for antithrombotic therapy and recommended prophylaxis for DVT/VTE. The properties and monitoring of various anticoagulants including heparin, warfarin, low molecular weight heparin, and antiplatelet medications are discussed. Guidelines for the use of neuraxial techniques in patients on different anticoagulation regimens are provided.
The document discusses the risks and management of neuraxial anesthesia in patients receiving anticoagulant or antiplatelet medications. It states that while neuraxial techniques can reduce thromboembolic risks, anticoagulants are still often needed and precautions must be taken with neuraxial blocks. The timing of medication discontinuation, monitoring of coagulation parameters, and catheter management varies depending on the specific agent and dosing regimen. Neurological monitoring is important when combining these techniques due to the rare but serious risk of spinal hematoma.
The document summarizes the 2010 recommendations of the European Society of Anesthesiology on neuraxial anesthesia and antithrombotic drugs. It provides time intervals that should elapse between taking different antithrombotic medications and performing neuraxial blocks or catheter removals based on the half-lives of the drugs. It also discusses preoperative versus postoperative thromboprophylaxis and considerations for various classes of antithrombotic agents including heparins, anti-Xa agents, direct thrombin inhibitors, vitamin K antagonists, and platelet aggregation inhibitors.
This document discusses anesthesia for patients on anticoagulant therapy. It provides an overview of hemostasis and the coagulation cascade involving platelets and clotting factors. Key laboratory tests for assessing coagulation are described, including prothrombin time (PT), international normalized ratio (INR), partial thromboplastin time (PTT), thrombin time, and thromboelastography. Common anticoagulants like heparin and warfarin are explained in terms of their mechanisms and monitoring. Warfarin inhibits vitamin K dependent clotting factors and its effect is monitored by PT/INR, while heparin acts by binding to antithrombin.
Anesthesia in patients on anti coagulantsNavin Jain
This document discusses anesthesia considerations for patients on various anticoagulant medications. It reviews the coagulation cascade and indications for anticoagulation therapy. Common anticoagulants are described including antiplatelet drugs, oral anticoagulants like warfarin, heparins, and newer agents. Guidelines are provided for managing patients on these medications in the perioperative period, including recommendations for stopping medications prior to procedures and resuming them postoperatively. Specific guidance is given for neuraxial anesthesia in anticoagulated patients.
The document provides guidelines from the American Society of Regional Anesthesia (ASRA) on placing and removing epidural catheters in patients taking anticoagulant and antiplatelet drugs. It lists recommended minimum times to wait after the last dose of various medications before catheter placement and removal, as well as when to restart anticoagulation therapy after removal. The medications are grouped into heparins, low molecular weight heparins, factor Xa and direct thrombin inhibitors, antiplatelet agents, fibrinolytics, and glycoprotein IIb/IIIa inhibitors. For each group, it provides the drug names and recommended waiting times.
Anticoagulants, antiplatelet drugs and anesthesiaRajesh Munigial
It is a presentation on anticoagulants and antiplatelets in anesthesia , starting from basis of coagulation , its tests and dugs and anesthetic implications
Based on latest ASRA (AMERICAN SOCIETY OF REGIONAL ANESTHESIA GUIDELINES)
This document discusses regional anesthesia and antithrombotic drugs. It notes that vertebral canal hematoma is a rare but potentially devastating complication of central neuraxial blockade, especially for patients taking anticoagulant or antithrombotic drugs. It provides guidance on timing the administration of various antithrombotic drugs like aspirin, clopidogrel, enoxaparin and warfarin in relation to regional anesthesia to minimize bleeding risks. It also discusses risk factors and considerations for different types of regional techniques and antithrombotic drugs.
This document discusses anticoagulation and neuraxial anesthesia/analgesia. It provides an overview of case reports of epidural hematomas occurring with the anticoagulant Lovenox. It then reviews indications for antithrombotic therapy and recommended prophylaxis for DVT/VTE. The properties and monitoring of various anticoagulants including heparin, warfarin, low molecular weight heparin, and antiplatelet medications are discussed. Guidelines for the use of neuraxial techniques in patients on different anticoagulation regimens are provided.
The document discusses the risks and management of neuraxial anesthesia in patients receiving anticoagulant or antiplatelet medications. It states that while neuraxial techniques can reduce thromboembolic risks, anticoagulants are still often needed and precautions must be taken with neuraxial blocks. The timing of medication discontinuation, monitoring of coagulation parameters, and catheter management varies depending on the specific agent and dosing regimen. Neurological monitoring is important when combining these techniques due to the rare but serious risk of spinal hematoma.
The document summarizes the 2010 recommendations of the European Society of Anesthesiology on neuraxial anesthesia and antithrombotic drugs. It provides time intervals that should elapse between taking different antithrombotic medications and performing neuraxial blocks or catheter removals based on the half-lives of the drugs. It also discusses preoperative versus postoperative thromboprophylaxis and considerations for various classes of antithrombotic agents including heparins, anti-Xa agents, direct thrombin inhibitors, vitamin K antagonists, and platelet aggregation inhibitors.
This document provides guidelines for holding and restarting various anticoagulant and antiplatelet medications before, during, and after procedures involving neuraxial catheters. It lists medications such as heparin, warfarin, low molecular weight heparins, direct thrombin inhibitors, and others along with recommended hold times and when to restart each medication. It also includes each medication's mechanism of action and half-life.
This document discusses guidelines for performing neuraxial blocks in patients who require anticoagulation or antiplatelet therapy. It provides an overview of various anticoagulant and antiplatelet medications, including their mechanisms of action, dosages, and monitoring parameters. For each medication, recommendations are given on appropriate timing of neuraxial blocks or catheter removal in relation to the medication. The risks of spinal hematoma are also discussed. Overall, the document provides expert consensus guidelines on safely managing regional anesthesia for patients on various coagulation-altering medications.
Management of patient with anticoagulant therapySk Aziz Ikbal
This document discusses the management of patients undergoing dental procedures who are taking anticoagulant medications. It notes that anticoagulants prevent blood clotting by suppressing clotting factors. For patients taking warfarin, the INR should be monitored and lowered to 1.5 times normal range prior to procedures to reduce bleeding risk if deemed safe by a physician. Heparin can be stopped 6 hours before surgery and restarted once clotting occurs. Post-operative care includes use of antifibrinolytics and penicillin to prevent excess bleeding and diet of cool liquids for several days.
This document summarizes guidelines from the 4th Edition of the American Society of Regional Anesthesia and Pain Medicine on the anesthetic management of patients receiving various antithrombotic therapies. It outlines recommendations regarding neuraxial blocks and catheter management for patients taking medications such as thrombolytics, unfractionated heparin, low molecular weight heparin, and newer oral anticoagulants. The guidelines provide evidence-based recommendations on timing of blocks and catheter removal in relation to medication dosing and coagulation status monitoring. They emphasize the importance of interdisciplinary communication and individualized clinical decision making to minimize risks while providing optimal pain management.
This document discusses the care of patients on anticoagulant medications. It describes different types of anticoagulants including heparin, low molecular weight heparins, and warfarin. It provides details on the mechanisms of action, indications, dosing, administration, monitoring, advantages and disadvantages of these drugs. The document also outlines important nursing considerations when caring for patients taking anticoagulants such as monitoring for bleeding, dietary restrictions, medication compliance, and patient education.
This document discusses direct oral anticoagulants (DOACs) including their classification, mechanisms of action, drugs, indications, dosages, and reversal agents. It covers the management of bleeding in patients taking DOACs and the perioperative management of patients receiving anticoagulants. It also discusses oral anticoagulant use in patients with atrial fibrillation and chronic kidney disease, focusing on the renal excretion of DOACs.
Shock in a Trauma patient - a maxillofacial perspectiveKeerthana Ashok
This document discusses shock in trauma patients from a maxillofacial perspective. It defines shock and describes the different types of shock. It discusses the physiologic response to hemorrhage, including the lethal triad of trauma. It covers clinical presentation of hemorrhagic shock, fluid compartments, estimation of blood volume and fluid deficits. It also discusses resuscitation fluids, damage control resuscitation protocol, distribution of facial trauma that can lead to massive hemorrhage, and methods for managing hemorrhage.
Anticoagulant treatment involves interfering with the blood clotting mechanism to prevent or treat blood clots. Common indications for anticoagulant therapy include atrial fibrillation, heart valve disease, deep vein thrombosis, pulmonary embolism, and ischemic heart disease. Warfarin and heparin are commonly used oral and injectable anticoagulants, respectively. Dental procedures on patients taking anticoagulants require monitoring coagulation levels and controlling bleeding risks.
This document provides guidelines for managing severe local anesthetic toxicity:
1. Signs of toxicity include sudden changes in mental status, seizures, and cardiovascular collapse. Immediate steps are to secure the airway, provide oxygen, treat seizures, and assess the cardiovascular system.
2. For circulatory arrest, start CPR and treat arrhythmias. Consider lipid emulsion and continue CPR during treatment. For stable patients, consider lipid emulsion and treat hypotension, bradycardia, or tachyarrhythmias.
3. Follow up includes monitoring for pancreatitis, reporting cases, and safe transfer until recovery is achieved.
Emergency Management of Patients Taking Direct Oral AnticoagulantsUFJaxEMS
Direct oral anticoagulants (DOACs) like dabigatran, rivaroxaban, apixaban, and edoxaban are increasingly used alternatives to warfarin for stroke prevention in atrial fibrillation and treatment of venous thromboembolism. They have more predictable pharmacokinetics than warfarin, avoiding the need for routine monitoring, but specific reversal agents are limited. Idarucizumab is approved for dabigatran reversal while prothrombin complex concentrates may help reverse factor Xa inhibitors like rivaroxaban off-label. Management of bleeding depends on its severity, location, time since last dose, and thrombosis risk. Procedures
New oral anticoagulants (NOAC) WATAG guidelinesSCGH ED CME
The document summarizes guidelines for new oral anticoagulants (NOACs) such as dabigatran, rivaroxaban, and apixaban. It outlines their development as alternatives to traditional anticoagulants which have limitations including a narrow therapeutic window and need for monitoring. The NOACs have faster onset, shorter half-lives, and less drug interactions than traditional options. The document reviews indications, dosing, switching between anticoagulants, management of bleeding, and prescribing considerations for the new oral anticoagulants.
Administration & Calculation Of Drugs, Iv Fluidsmohammed indanan
The document discusses the administration of various medical substances including drugs, intravenous fluids, blood, and blood components. It provides guidelines for proper ordering, transcription, administration, and documentation of drugs. It also outlines guidelines for intravenous fluid therapy, drug calculations, ordering and administering blood and blood components, and responding to transfusion reactions. Proper patient identification, consent, and monitoring are emphasized.
This document summarizes the development of newer anticoagulants, including direct thrombin inhibitors and factor Xa inhibitors. It discusses the limitations of older anticoagulants like heparin, warfarin, and low molecular weight heparins. Newer oral anticoagulants like dabigatran, rivaroxaban, apixaban and edoxaban directly inhibit thrombin or factor Xa and have improved properties over warfarin such as fewer drug and food interactions and more predictable dosing without monitoring. Clinical trials found these newer anticoagulants to be as effective or more effective than warfarin or enoxaparinux for preventing strokes in atrial fibrill
- This document summarizes guidelines from the Surviving Sepsis Campaign for the management of severe sepsis and septic shock.
- The guidelines recommend beginning resuscitation immediately for patients with hypotension or elevated lactate, obtaining cultures before antibiotics, administering broad-spectrum antibiotics within 1 hour, and controlling blood glucose with insulin.
- For patients requiring vasopressors, the guidelines suggest considering vasopressin, dobutamine, or hydrocortisone therapy and treating with recombinant human activated protein C for certain high-risk patients.
This document discusses antiplatelet agents used for cardiovascular disease. It describes the mechanisms of action, indications, dosing, side effects, and perioperative management of various antiplatelet drugs including aspirin, clopidogrel, ticlopidore, ticagrelor, prasugrel, cangrelor, abciximab, eptifibatide, tirofiban, dipyridamole, vorapaxar, and atopaxar. It also discusses the use of antiplatelet therapy for primary and secondary prevention of cardiovascular events such as cardiovascular death, stroke, and myocardial infarction, as well as for peripheral artery disease.
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.
SCHUL.Update on Reversal Agents.16-FEB-16Marlin Schul
This document summarizes recent updates on reversal agents for new oral anticoagulants (TSOACs). It discusses the benefits of TSOACs like easy compliance and short half-lives, but also the challenges they present for reversing bleeding risks without established antidotes. Potential reversal agents discussed include prothrombin complex concentrate, activated prothrombin complex concentrate, recombinant factor VIIa, and the small molecule aripazine. Specific reversal agents idarucizumab for dabigatran and andexanet alfa for factor Xa inhibitors are presented, along with consensus recommendations for when and how to reverse bleeding risks from TSOACs.
Dr. Ahmad Jaihan Bin Ismail presented on the case of a 33-year-old man admitted for necrotizing fasciitis of the right lower limb who required peripheral nerve blocks for debridement surgery. During the procedure, the patient developed symptoms of local anesthetic toxicity including difficulty swallowing, lip numbness, and a seizure. He was intubated and stabilized in the ICU. The presentation discussed the history of local anesthetics, mechanisms of action, pharmacokinetics, techniques for safe administration, as well as risk factors and management of local anesthetic toxicity.
This document discusses the dental management of patients taking anticoagulant and antiplatelet drugs. It provides background on hemostasis and the mechanisms of action of anticoagulants like warfarin and antiplatelet drugs like aspirin. It reviews studies showing that minor dental procedures can often be performed without altering anticoagulant/antiplatelet therapy if the INR is therapeutic and local measures are used to control bleeding. For extensive procedures or supratherapeutic INRs, consulting the prescribing physician is recommended. Careful technique and local hemostatic measures can control postoperative bleeding in most medicated patients.
Oral Surgery in Patients on Anticoagulant TherapyVarun Mittal
Management of patients on Anticoagulant Therapy in Surgical Practice with special emphasis on Oral Surgical Procedures; along with Guidelines drawn from various Text Books and Journals
This document provides guidelines for holding and restarting various anticoagulant and antiplatelet medications before, during, and after procedures involving neuraxial catheters. It lists medications such as heparin, warfarin, low molecular weight heparins, direct thrombin inhibitors, and others along with recommended hold times and when to restart each medication. It also includes each medication's mechanism of action and half-life.
This document discusses guidelines for performing neuraxial blocks in patients who require anticoagulation or antiplatelet therapy. It provides an overview of various anticoagulant and antiplatelet medications, including their mechanisms of action, dosages, and monitoring parameters. For each medication, recommendations are given on appropriate timing of neuraxial blocks or catheter removal in relation to the medication. The risks of spinal hematoma are also discussed. Overall, the document provides expert consensus guidelines on safely managing regional anesthesia for patients on various coagulation-altering medications.
Management of patient with anticoagulant therapySk Aziz Ikbal
This document discusses the management of patients undergoing dental procedures who are taking anticoagulant medications. It notes that anticoagulants prevent blood clotting by suppressing clotting factors. For patients taking warfarin, the INR should be monitored and lowered to 1.5 times normal range prior to procedures to reduce bleeding risk if deemed safe by a physician. Heparin can be stopped 6 hours before surgery and restarted once clotting occurs. Post-operative care includes use of antifibrinolytics and penicillin to prevent excess bleeding and diet of cool liquids for several days.
This document summarizes guidelines from the 4th Edition of the American Society of Regional Anesthesia and Pain Medicine on the anesthetic management of patients receiving various antithrombotic therapies. It outlines recommendations regarding neuraxial blocks and catheter management for patients taking medications such as thrombolytics, unfractionated heparin, low molecular weight heparin, and newer oral anticoagulants. The guidelines provide evidence-based recommendations on timing of blocks and catheter removal in relation to medication dosing and coagulation status monitoring. They emphasize the importance of interdisciplinary communication and individualized clinical decision making to minimize risks while providing optimal pain management.
This document discusses the care of patients on anticoagulant medications. It describes different types of anticoagulants including heparin, low molecular weight heparins, and warfarin. It provides details on the mechanisms of action, indications, dosing, administration, monitoring, advantages and disadvantages of these drugs. The document also outlines important nursing considerations when caring for patients taking anticoagulants such as monitoring for bleeding, dietary restrictions, medication compliance, and patient education.
This document discusses direct oral anticoagulants (DOACs) including their classification, mechanisms of action, drugs, indications, dosages, and reversal agents. It covers the management of bleeding in patients taking DOACs and the perioperative management of patients receiving anticoagulants. It also discusses oral anticoagulant use in patients with atrial fibrillation and chronic kidney disease, focusing on the renal excretion of DOACs.
Shock in a Trauma patient - a maxillofacial perspectiveKeerthana Ashok
This document discusses shock in trauma patients from a maxillofacial perspective. It defines shock and describes the different types of shock. It discusses the physiologic response to hemorrhage, including the lethal triad of trauma. It covers clinical presentation of hemorrhagic shock, fluid compartments, estimation of blood volume and fluid deficits. It also discusses resuscitation fluids, damage control resuscitation protocol, distribution of facial trauma that can lead to massive hemorrhage, and methods for managing hemorrhage.
Anticoagulant treatment involves interfering with the blood clotting mechanism to prevent or treat blood clots. Common indications for anticoagulant therapy include atrial fibrillation, heart valve disease, deep vein thrombosis, pulmonary embolism, and ischemic heart disease. Warfarin and heparin are commonly used oral and injectable anticoagulants, respectively. Dental procedures on patients taking anticoagulants require monitoring coagulation levels and controlling bleeding risks.
This document provides guidelines for managing severe local anesthetic toxicity:
1. Signs of toxicity include sudden changes in mental status, seizures, and cardiovascular collapse. Immediate steps are to secure the airway, provide oxygen, treat seizures, and assess the cardiovascular system.
2. For circulatory arrest, start CPR and treat arrhythmias. Consider lipid emulsion and continue CPR during treatment. For stable patients, consider lipid emulsion and treat hypotension, bradycardia, or tachyarrhythmias.
3. Follow up includes monitoring for pancreatitis, reporting cases, and safe transfer until recovery is achieved.
Emergency Management of Patients Taking Direct Oral AnticoagulantsUFJaxEMS
Direct oral anticoagulants (DOACs) like dabigatran, rivaroxaban, apixaban, and edoxaban are increasingly used alternatives to warfarin for stroke prevention in atrial fibrillation and treatment of venous thromboembolism. They have more predictable pharmacokinetics than warfarin, avoiding the need for routine monitoring, but specific reversal agents are limited. Idarucizumab is approved for dabigatran reversal while prothrombin complex concentrates may help reverse factor Xa inhibitors like rivaroxaban off-label. Management of bleeding depends on its severity, location, time since last dose, and thrombosis risk. Procedures
New oral anticoagulants (NOAC) WATAG guidelinesSCGH ED CME
The document summarizes guidelines for new oral anticoagulants (NOACs) such as dabigatran, rivaroxaban, and apixaban. It outlines their development as alternatives to traditional anticoagulants which have limitations including a narrow therapeutic window and need for monitoring. The NOACs have faster onset, shorter half-lives, and less drug interactions than traditional options. The document reviews indications, dosing, switching between anticoagulants, management of bleeding, and prescribing considerations for the new oral anticoagulants.
Administration & Calculation Of Drugs, Iv Fluidsmohammed indanan
The document discusses the administration of various medical substances including drugs, intravenous fluids, blood, and blood components. It provides guidelines for proper ordering, transcription, administration, and documentation of drugs. It also outlines guidelines for intravenous fluid therapy, drug calculations, ordering and administering blood and blood components, and responding to transfusion reactions. Proper patient identification, consent, and monitoring are emphasized.
This document summarizes the development of newer anticoagulants, including direct thrombin inhibitors and factor Xa inhibitors. It discusses the limitations of older anticoagulants like heparin, warfarin, and low molecular weight heparins. Newer oral anticoagulants like dabigatran, rivaroxaban, apixaban and edoxaban directly inhibit thrombin or factor Xa and have improved properties over warfarin such as fewer drug and food interactions and more predictable dosing without monitoring. Clinical trials found these newer anticoagulants to be as effective or more effective than warfarin or enoxaparinux for preventing strokes in atrial fibrill
- This document summarizes guidelines from the Surviving Sepsis Campaign for the management of severe sepsis and septic shock.
- The guidelines recommend beginning resuscitation immediately for patients with hypotension or elevated lactate, obtaining cultures before antibiotics, administering broad-spectrum antibiotics within 1 hour, and controlling blood glucose with insulin.
- For patients requiring vasopressors, the guidelines suggest considering vasopressin, dobutamine, or hydrocortisone therapy and treating with recombinant human activated protein C for certain high-risk patients.
This document discusses antiplatelet agents used for cardiovascular disease. It describes the mechanisms of action, indications, dosing, side effects, and perioperative management of various antiplatelet drugs including aspirin, clopidogrel, ticlopidore, ticagrelor, prasugrel, cangrelor, abciximab, eptifibatide, tirofiban, dipyridamole, vorapaxar, and atopaxar. It also discusses the use of antiplatelet therapy for primary and secondary prevention of cardiovascular events such as cardiovascular death, stroke, and myocardial infarction, as well as for peripheral artery disease.
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.
SCHUL.Update on Reversal Agents.16-FEB-16Marlin Schul
This document summarizes recent updates on reversal agents for new oral anticoagulants (TSOACs). It discusses the benefits of TSOACs like easy compliance and short half-lives, but also the challenges they present for reversing bleeding risks without established antidotes. Potential reversal agents discussed include prothrombin complex concentrate, activated prothrombin complex concentrate, recombinant factor VIIa, and the small molecule aripazine. Specific reversal agents idarucizumab for dabigatran and andexanet alfa for factor Xa inhibitors are presented, along with consensus recommendations for when and how to reverse bleeding risks from TSOACs.
Dr. Ahmad Jaihan Bin Ismail presented on the case of a 33-year-old man admitted for necrotizing fasciitis of the right lower limb who required peripheral nerve blocks for debridement surgery. During the procedure, the patient developed symptoms of local anesthetic toxicity including difficulty swallowing, lip numbness, and a seizure. He was intubated and stabilized in the ICU. The presentation discussed the history of local anesthetics, mechanisms of action, pharmacokinetics, techniques for safe administration, as well as risk factors and management of local anesthetic toxicity.
This document discusses the dental management of patients taking anticoagulant and antiplatelet drugs. It provides background on hemostasis and the mechanisms of action of anticoagulants like warfarin and antiplatelet drugs like aspirin. It reviews studies showing that minor dental procedures can often be performed without altering anticoagulant/antiplatelet therapy if the INR is therapeutic and local measures are used to control bleeding. For extensive procedures or supratherapeutic INRs, consulting the prescribing physician is recommended. Careful technique and local hemostatic measures can control postoperative bleeding in most medicated patients.
Oral Surgery in Patients on Anticoagulant TherapyVarun Mittal
Management of patients on Anticoagulant Therapy in Surgical Practice with special emphasis on Oral Surgical Procedures; along with Guidelines drawn from various Text Books and Journals
The document provides 11 cognitive aids developed by the Society for Neuroscience in Anesthesia and Critical Care to assist anesthesia teams facing neuroanesthetic emergencies. Each cognitive aid outlines the differential diagnosis, treatment steps to stabilize the patient, and treatment guidance for common neurosurgical emergencies including acute stroke, aneurysm rupture, intraoperative aneurysm rupture, autonomic hyperreflexia, bleeding during spine surgery, and delayed emergence after craniotomy. The cognitive aids are not protocols but are meant to provide resources during emergent situations.
This document provides information on several vasoconstricting drugs and their uses:
- Vasoconstrictors like epinephrine, norepinephrine, vasopressin, and phenylephrine are used to treat low blood pressure, with epinephrine and vasopressin being first-line treatments for pulseless cardiac arrest.
- Drugs used in cardiac arrest situations include epinephrine, vasopressin, amiodarone, lidocaine, and atropine according to ACLS guidelines. Epinephrine and vasopressin increase blood pressure while amiodarone treats shock-resistant arrhythmias.
- Dopamine, administered via IV drip, is used
This document discusses anticoagulation and neuraxial anesthesia. It begins by introducing some risks of anticoagulation like bleeding. It then focuses on the risks of spinal and epidural hematoma formation during regional anesthesia when patients are anticoagulated. It provides recommendations from ASRA on the timing of regional blocks for various anticoagulants like heparin, LMWH, warfarin, antiplatelets, and newer anticoagulants. It also briefly discusses peripheral nerve blocks and herbal therapies. The recommendations aim to balance thrombosis prevention with bleeding risks from regional anesthesia.
The document provides an overview of managing patients with bleeding disorders. It discusses hemostasis, common lab tests used to evaluate clotting mechanisms, and causes of bleeding disorders including platelet disorders and factor deficiencies. Guidelines are presented for identifying patients with bleeding disorders based on their history. Techniques to maintain hemostasis during surgery include using a harmonic scalpel. The document also reviews recommendations for treating patients taking antiplatelet drugs, anticoagulants, or fibrinolytic drugs and discusses hemophilia and conclusions.
Hematologic drugs are used to treat various blood disorders like thrombosis, bleeding, and anemia. The document discusses several classes of drugs including anticoagulants, antiplatelets, thrombolytics, agents to treat bleeding, antihyperlipidemics, and antianemics. Specific drugs within each class like heparin, warfarin, aspirin, streptokinase, iron, and erythropoietin are explained in terms of their mechanisms of action, indications, adverse effects and nursing considerations.
The document discusses various hematologic drugs used to treat conditions related to blood circulation. It covers the mechanisms, indications, contraindications, side effects and nursing considerations for different classes of drugs including anticoagulants, antiplatelets, thrombolytics, agents to treat bleeding, antihyperlipidemics, and antianemics.
This document provides prescribing information for NOVOSEVEN® RT (coagulation factor VIIa, recombinant), including important safety warnings, indications, dosage and administration instructions, adverse reactions, and drug interactions. Key details include:
- NOVOSEVEN® RT is indicated for bleeding episodes and perioperative management in patients with hemophilia A/B with inhibitors, congenital factor VII deficiency, acquired hemophilia, or Glanzmann's thrombasthenia.
- Dosing is dependent on the condition and type of bleeding/surgery, with doses ranging from 15-90 mcg/kg administered every 2-6 hours.
- A black box warning indicates serious arterial and venous throm
This document discusses anticoagulant drugs including unfractionated heparin, low molecular weight heparins, warfarin, and novel oral anticoagulants. It covers the mechanisms of action, indications, monitoring, perioperative management, and reversal of anticoagulation for bleeding events. Key points include how unfractionated heparin acts by inhibiting thrombin and other clotting factors, how warfarin inhibits vitamin K to reduce clotting factor production, and advantages of novel oral anticoagulants over warfarin in terms of pharmacokinetics and indications.
1. Warfarin is a commonly used oral anticoagulant that is rapidly absorbed and has a high bioavailability but also a long half-life of 36-42 hours.
2. Warfarin is dosed once daily and monitored through PT and INR measurements to maintain therapeutic levels for different conditions.
3. Overdose of warfarin can be managed by withholding the drug and administering vitamin K or fresh frozen plasma depending on the severity of elevation of PT and INR.
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to an infection.The definition of sepsis was updated in 2016 following publication of the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). This recommended that organ dysfunction should be defined using the Sequential (or Sepsis-related) Organ Failure Assessment (SOFA) criteria or the "quick" (q)SOFA criteria.
Rational choice of inotropes and vasopressors in intensive care unitSaneesh P J
The presentation introduces commonly used interpose and vasopressors; their classification; and how to choose the drug in ICU. Clinical scenarios - cariogenic shock; neurocritical care; septic shock and anaphylactic shock are elaborated.
This document provides guidelines for using aciclovir to treat herpes simplex encephalitis and neonatal herpes simplex and varicella zoster infections. It details the indications, dosing, administration, side effects and incompatibilities of both intravenous and oral aciclovir formulations for neonatal use.
1) Hemodialysis and CRRT are renal replacement therapies used to treat acute kidney injury by removing waste and fluid from the blood. CRRT provides more gradual and continuous treatment compared to intermittent hemodialysis.
2) Indications for RRT include fluid overload, hyperkalemia, acidosis, rising urea/creatinine, uraemia symptoms, and sepsis. The choice of RRT depends on what needs to be removed, the patient's stability, resources, and clinical factors.
3) CRRT modalities include CVVH, CVVHD, and CVVHDF. Anticoagulation is usually needed but can be avoided if the patient is already coagulo
This document provides guidelines for the management of severe sepsis and septic shock according to the Surviving Sepsis Campaign. It outlines diagnostic criteria for sepsis, septic shock, and organ dysfunction. It also details bundles of care that should be completed within 3 and 6 hours of diagnosis, including measuring lactate levels, administering antibiotics and fluids, and applying vasopressors if needed. The guidelines provide recommendations on initial resuscitation, antibiotic therapy, source control, infection prevention, fluid therapy, vasopressors, corticosteroids, mechanical ventilation, and other supportive care measures for managing sepsis.
1. The document provides instructions for a patient with peripheral artery disease (PAD) and endocarditis, including wound care, antibiotic use, and signs of complications to watch for.
2. It also outlines teaching for a patient receiving a pacemaker, including limitations on physical activity, wound care, and when to raise the arm.
3. The document discusses monitoring laboratory values for patients receiving heparin or warfarin therapy.
DVT most commonly occurs in the lower extremities and pelvis, causing symptoms like leg pain and swelling. It is a common complication for hospitalized patients and those with injuries. Treatment involves blood thinners, compression stockings, and filters to prevent clots from dislodging and causing pulmonary embolisms. Anticoagulants like heparin and warfarin are used long-term to prevent recurrence and complications, while newer drugs provide alternatives. Early diagnosis and treatment can help manage this condition and reduce risks of long-term issues.
This document discusses various parenteral anticoagulants including indirect thrombin inhibitors like unfractionated heparin and low molecular weight heparins, as well as direct thrombin inhibitors like lepirudin, bivalirudin, and argatroban. It provides details on their mechanisms of action, pharmacokinetics, uses, dosages and administration. Selective factor Xa inhibitors like fondaparinux are also covered. The document is intended to serve as an introduction and overview of different types of parenteral anticoagulants.
Similar to EPVC newsletter sixty january 2015 (20)
The document summarizes recent developments in vaccines:
1) The FDA approved Sanofi Pasteur's Quadracel vaccine for children aged 4-6, protecting against diphtheria, tetanus, pertussis and polio with fewer injections.
2) A Phase I trial found an Ebola vaccine based on the 2014 outbreak strain was safe and provoked an immune response in 95-100% of recipients.
3) An 80-patient Phase II trial launched to test a diabetes vaccine in children at high risk of Type 1 diabetes to see if it can prevent or delay onset.
The document summarizes recent news in the field of pharmacovigilance and vaccines. It discusses a new HPV vaccine that prevents multiple cancers, efforts to develop a synthetic polio vaccine, a new 3D vaccine for cancer research, and WHO approval of a meningitis vaccine for infants in Africa. It also mentions funding from the Gates Foundation for the synthetic polio vaccine and potential for an anti-HIV agent or Ebola vaccine. The newsletter provides updates on regulatory issues, recalls, and safety announcements regarding medications in Egypt.
EPVC newsletter sixty one -february 2015amin mohamed
The document provides information from the Egyptian Pharmaceutical Vigilance Center's newsletter including:
1) A training on epidemiology organized by EPVC for 48 attendees covering topics like pharmacoepidemiology and evidence-based medicine.
2) A recall of Solgar ABC Dophilus powder due to risk of rare fungal infection from detected presence of Rhizopus oryzae mold, which can be dangerous for certain groups.
3) A case report of abortion in a pregnant woman who took the urinary tract infection drug Nitrofurantoin, highlighting its risks and labeling around use in pregnancy.
المكتب العلمى هو اى مكتب يقوم بأعمال الدعايا للادوية والمنتجات والمستلزمات الطبية والكيماويات الدوائية وما تقتضيه هذة الدعاية من تزويد نقابات المهن الطبية وغيرهم ممن يهمهم الامر بالمعلومات العلمية عن المستحضرات والمستلزمات والادوية التى تنتجها المصانع التابعة لها هذة المكاتب وذلك عن طريق الوسائل الاعلامية المختلفة من القاء المحاضرات وعقد الندوات العامة والمعاونة فى البحوث العلمیة وعرض الافلام وتوزیع النشرات والعینات المجانیة وغیر ذلك.
The document discusses the acute abdomen, which refers to intra-abdominal disease that is often best treated surgically. It outlines characteristics of patients who need surgery versus those who do not, and provides potential non-surgical and metabolic causes of acute abdominal pain. The physiology of abdominal pain and patterns of referred pain are described. A history and physical exam are important for diagnosis, with differential diagnoses provided for various locations of abdominal pain. Immediate treatment of the acute abdomen includes IV fluids, pain medication, tubes, antibiotics, and definitive therapy based on diagnosis.
Hypertension and it's role of physiotherapy in it.Vishal kr Thakur
This particular slides consist of- what is hypertension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is summary of hypertension -
Hypertension, also known as high blood pressure, is a serious medical condition that occurs when blood pressure in the body's arteries is consistently too high. Blood pressure is the force of blood pushing against the walls of blood vessels as the heart pumps it. Hypertension can increase the risk of heart disease, brain disease, kidney disease, and premature death.
This particular slides consist of- what is hypotension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.
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NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTblessyjannu21
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1. Part I of II
EPVC Newsletter
Egyptian
Pharmaceutical
Vigilance Center
(EPVC)
Pharmacovigilance
Department
Inside this issue:
EPVC regional
center in Cairo -
Hospitals QPPVs
Pharmacovigilance
training workshop
in Mansoura
1
Noradrenaline -
Case of Peripheral
Limb Ischemia/
Cyanosis in Female
Patient in Cairo.
1
Heparin Sodium -
High Sodium level
in withdrawn blood
sample - Case of
High Sodium level
in withdrawn blood
sample due to Hepa-
rin sodium flushing
solution - Cairo"
4
Volume 6, Issue 1January 2015
EPVC regional center in Cairo - Hospitals QPPVs
Pharmacovigilance training workshop in Mansoura
During the period from 2nd to
3rd December 2014, The regional
center in Cairo had organized
“hospital QPPVs training workshop”
which was held in Mansoura gover-
norate.
156 pharmacists from all Man-
sora hospitals and health institutions,
were highly selected by their manag-
ers to act as QPPV representatives
and contact points at their work plac-
es.
The regional center in Cairo is
willing to organize another wave in
El-Menoufya at the end of February
2015, in order to introduce and apply
the Pharmacovigilance system to all
Cairo hospitals and health care insti-
tutions.
Noradrenaline - Case of Peripheral Limb Ischemia/
Cyanosis in Female Patient in Cairo
The regional center in Cairo re-
ceived a yellow card concerning a Nine-
ty Two Years old female who was ad-
mitted to ICU by abdominal distension,
anorexia, and was diagnosed by acute
renal failure, anemia, septic shock, in-
testinal obstruction with history of DM.
The patient received Noradrenaline IV
for hypotension (dose ranging from 0.01
to 0.4 mcg/kg/min according to her
blood pressure) to control her blood
pressure. She developed Peripheral
Limb Ischemia and Cyanosis (blue dig-
its)
Background:
Noradrenaline is indicated for the emer-
gency restoration of blood pressure in
cases of acute hypotension.(1, 2)
Each
8ml ampoule contains 16mg Nora-
drenaline tartrate equivalent to 8mg
Noradrenaline base. (1)
Blue digits: ischemic injury and cya-
nosis due to potent vasoconstrictor
action, resulting from norepineph-
2. Volume 6, Issue 1Page 2 Part I EPVC
rine treatment. (1)
Extravasation risk: The infusion site should be
checked frequently for free flow. Care should be
taken to avoid extravasation that would cause a
necrosis of the tissues surrounding the vein used
for the injection. (1)
Labeled Information:
According to Noradrenaline Summary of product
Characteristics (SmPC) (1)
it was stated under sec-
tion (4.2 Posology and method of administration),
the following:
Titration of Dose:
The dose should be titrated according to the pressor
effect observed. There is great individual variation
in the dose required to attain and maintain nor-
motension. (1, 2)
The aim should be to establish a low normal sys-
tolic blood pressure (100-120 mm Hg) or to
achieve an adequate mean arterial blood pressure
(greater than 65 to 80 mm Hg - depending on the
patient's condition). (1, 2)
Duration of Treatment and Monitoring:
Noradrenaline should be continued for as long as
vasoactive drug support is indicated. The patient
should be monitored carefully for the duration of
noradrenaline therapy. (1, 2)
Dilution Instructions:
Either add 2 ml of Noradrenaline 1 MG/ML to 48
ml 5% dextrose (or isotonic dextrose saline) for
administration by syringe pump, or add 20 ml of
Noradrenaline 1 MG/ML to 480 ml 5% dextrose
(or isotonic dextrose saline) for administration by
drip counter. (1, 2)
In the both cases the final concentration of the
infusion solution is 80 mg/litre noradrenaline
tartrate, which is equivalent to 40 mg/litre nora-
drenaline base. If other dilutions are used check
the calculation carefully before starting treat-
ment. (1, 2)
Blood Pressure Control:
Measure blood pressure every two minutes at the
beginning of the infusion until the desired blood
pressure is obtained. Then every five minutes
when desired the blood pressure is obtained, if
the administration has to be continued. The infu-
sion should be at a control rate and the patient
should be monitored carefully for the duration of
noradrenaline (norepinephrine) therapy. (1, 2)
Treatment of the Ischemia Due To
Extravasation:
During an extravascular leak of the product or an
injection besides the vein, tissue destruction can
appear resulting from the vasoconstrictive action
of the drug on the blood vessels. The injection
zone must be then irrigated as quickly as possible
with 10 to 15ml of physiological salt solution con-
taining 5 to 10 mg of phentolamine mesilate. For
this purpose, it is necessary to use a syringe pro-
vided with a fine needle and to inject locally. (1)
Use in the Elderly:
Clinical studies did not include sufficient numbers
of subjects aged 65 and over to determine whether
they respond differently from younger subjects. In
general, dose selection for an elderly patient
should be cautious, usually starting at the low end
of the dosing range, reflecting the greater frequen-
cy of decreased hepatic, renal, or cardiac function,
and of concomitant disease or other drug therapy.
Noradrenaline should not be administered into
the veins in the leg in elderly patients. (3)
Overdosage:
May result in severe hypertension, reflex brady-
3. Volume 6, Issue 1Page 3 Part I EPVC
cardia, marked increase in peripheral resistance and decreased cardiac output. Headache may indicate
severe hypertension. (3)
Recommendations for Healthcare Professionals:
1. Noradrenaline is for intravenous use only.(1,2)
2. Dilute before use. (1,2)
3. Administer as a diluted solution via a central venous catheter. (1,2)
4. The infusion should be at a controlled rate using either a syringe pump or an infusion pump or a
drip counter. (1,2)
5. Noradrenaline should be administered through central venous devices to minimize the risk of ex-
travasation and subsequent tissue necrosis. (1,2)
6. Avoid administration of vasopressor (to maintain blood pressure) in absence of blood volume re-
placement to avoid severe peripheral and visceral vasoconstriction, hypoxia and decrease in renal
blood flow. (2)
7. The infusion must not be stopped suddenly but should be gradually withdrawn to avoid disastrous
falls in blood pressure. (2)
8. Caution and respect of the strict indication must be retained in the following conditions:
Elderly ( may be especially sensitive to the effects of noradrenaline) (2)
Diabetic Patient. (2)
Hypotension following a heart attack. (2)
Clots or obstructions in the blood vessels supplying the heart, intestines, or other parts of the
body.(2)
Treatment:
The limb should be placed in loosened bandage, and apply an extremely warming device, such as Bair
Hugger, then:
consider pharmacologic therapy: Nifedipine 10 to 60 mg with aspirin 81 mg daily,
if no response occurred, chemical sympathectomy(5)
, by local infiltration of plain lidocaine,
if no improvement combine the use of transdermal nitroglycerin,
finally, short term heparin drip for 24 to 72 hours could be applied. (4)
References
1. Medicines.org.uk. (Click here)
2. Drugs.com. (Click here)
3. TGA eBS - Product and Consumer Medicine Infor-
mation Licence. (Click here)
4. Ravenell R, Powell D, Ryan J. Vasospastic Disor-
ders, Ischemic Digits, and The Use of Epinephrine in
Digital surgery [Internet]. The Podiatry Institute.
(Click here)
5. TheFreeDictionary.com. (Click here)
Real Photo of the Patient by the Report-
4. Volume 6, Issue 1Page 4 Part I EPVC
"Heparin Sodium - High Sodium level in withdrawn blood sample - Case of
High Sodium level in withdrawn blood sample due to Heparin sodium
flushing solution - Cairo"
The regional center in Cairo received a complaint
concerning intravenous devices that are flushed by
"Heparin sodium flushing solution" leading to
interference with results of the desired blood tests
"High Sodium level in withdrawn blood sample".
:Background
Heparin is a naturally occurring
mucopolysaccharide with in vitro and in vivo
anticoagulant activity. Heparin acts at multiple
sites in the normal coagulation systems. Small
amounts of heparin in combination with
antithrombin III (heparin cofactor) can inhibit
thrombosis by inactivating activated factor X and
inhibiting the conversion of prothrombin to
thrombin. (1)
Once active thrombosis has developed, larger
amounts of heparin can inhibit further
coagulation by inactivating thrombin, which in
turn prevents the conversion of fibrinogen to
fibrin. Under normal conditions, equilibrium
between fibrinogen deposition and lysis keeps the
vascular system free of thrombi. Under abnormal
conditions of trauma, surgery or circulatory
collapse, the equilibrium shifts towards clot
formation. The action of heparin is to shift the
equilibrium back towards normal thereby
reducing clot formation. (1)
Heparin catheter lock-flush solution Products
are intended to enhance the performance of intra-
vascular catheters. An intravascular catheter is a
device that consists of a slender tube and any
necessary connecting fittings that are inserted into
a patient's vascular system for short-term use (less
than 30 days )to sample blood, monitor blood
pressure, or administer fluids intravenously).
Heparin catheter lock-flush solutions are periodi-
cally inserted into and stored within the catheter
to keep the catheter patent and to prevent blood
from clotting within the catheter between uses. (2)
Labeled information:
According to Heparin Sodium 100 I.U./ml
flushing solution for maintenance of patency of
intravenous devices Summary of product Charac-
teristics (SmPC) (1)
it was stated under section
(4.5) Interaction with other medicinal products
and other forms of interaction) that:
When an indwelling device is used for repeated
withdrawal of blood samples for laboratory anal-
yses and the presence of heparin or saline is likely
to interfere with or alter results of the desired
blood tests, the in situ heparin flush solution
should be cleared from the device by aspirating
and discarding a volume of solution equivalent to
that of the indwelling venipuncture device before
the desired blood sample is taken. (3)
Recommendations for Healthcare
:Professionals
1. Heparin is not recommended for systemic use(3)
2. Caution should be exercised in patients with
known hypersensitivity to low molecular
weight heparins(3)
.
3. Rigorous aseptic technique should be observed
at all times in its use. (3)
4. Material to be used as an intravascular cannula
or catheter flush in doses of 200 units every 4
5. Volume 6, Issue 1Page 5 Part I EPVC
hours or as required. (3)
5. To maintain the patency of intravenous injection devices and prevent clot formation, flush the cathe-
ter/cannula with 10 - 50 IU every four hours. The solution may be used following initial placement
of the device in the vein, after each injection of a medication, or after withdrawal of blood for labora-
tory tests. (1)
6. Carefully examine all presentations of heparin sodium to confirm the correct formulation prior to ad-
ministration of the drug. (4)
7. When an indwelling device is used for repeated withdrawal of blood samples for laboratory analyses
and the presence of heparin or saline is likely to interfere with or alter results of the desired blood
tests, the in situ heparin flush solution should be cleared from the device by aspirating and discarding
a volume of solution equivalent to that of the indwelling venipuncture device before the desired blood
sample is taken. (3)
8. If the drug to be administered is incompatible with Heparin, the device must be flushed through with
normal 0.9% Sodium chloride solution before and after the drug is administered. (1)
9. Repeated flushing of a catheter device with heparin may result in a systemic anticoagulant effect. (3)
10. Platelet counts should be measured in patients receiving heparin flushes for longer than five days (or
earlier in patients with previous exposure to heparin). In those who develop thrombocytopenia or
paradoxical thrombosis, heparin should immediately be eliminated from all flushes and ports. [3]
11. Since repeated injections of small doses of heparin can alter tests for activated partial thromboplastin
time (APTT), a baseline value for APTT should be obtained prior to insertion of an intravenous de-
vice. (1)
References
1. Ebs.tga.gov.au. TGA eBS - Product and Consumer Medicine Information Licence [(Click Here)
2. Fda.gov. (Click Here)
3. Medicines.org.uk. (Click Here)
4. Health Canada. (Click Here)
6. Egypt reports 13th human H5N1 avian flu case in a month.National Organization
for Research &
Control of Biologicals
Post Marketing
Surveillance and
Adverse Event
Following
immunization
Department
Inside this issue:
Egypt reports 13th
human H5N1 avian flu
1
Powdered measles
vaccine, safe in phase I,
could aid vaccination in
1
Middle East respiratory
syndrome coronavirus
2
Breast cancer vaccine
looks promising in early
2
Universal dengue vac-
cine may be possible
thanks to antibody
3
FDA approves latest
HPV vaccine
3
NORCB Newsletter
Volume 5, Issue 12December 2014
The number of human H5N1 avian in-
fluenza (AI) cases continue their spike
in Egypt as health ministry officials ad-
vise of the 17th case of the year in three
year old child from Sohag Governorate.
This is the 13th H5N1 infection reported
out of Egypt in less than a month. Eight
fatalities have been reported.
This is the most cases and deaths due to
H5N1 AI in Egypt since 2011 when the
north African country reported 39 cases
and 15 deaths.
Since 2003, there has been nearly 700
human H5N1 AI cases reported with
only Indonesia reporting more cases
than Egypt.
H5N1 infection in humans can cause
severe disease and has a high mortality
rate. Almost all cases of H5N1 infection
in people have been associated with
close contact with infected live or dead
birds, or H5N1-contaminated environ-
ments.
The symptoms of H5N1 infection may
include fever (often high fever, > 38°C)
and malaise, cough, sore throat, and
muscle aches. Other early symptoms
may include abdominal pain, chest
pain and diarrhoea. The infection may
progress quickly to severe respiratory
illness (for example, difficulty breath-
ing or shortness of breath, pneumonia,
Acute Respiratory Distress Syndrome)
and neurologic changes (altered mental
status or seizures).
Reference
Outbreak News Today: (Click Here)
Powdered measles vaccine, safe in phase I, could aid
vaccination in developing world.
A powdered measles vaccine could
mean a cheaper option for the develop-
ing world that eliminates storage, con-
tamination and waste challenges. And
researchers now have one that looks
safe in Phase I.
In a Gates Foundation-backed study of
60 healthy, measles-immune men, re-
searchers from the Centers for Disease
Control and Prevention (CDC),
the Serum Institute of Indiaand else-
where found no clinically relevant side
effects and some evidence of a positive
immune response to the vaccine, ac-
cording to a paper published last week
in the journal Vaccine. The vaccine,
made of fine dry powder and delivered
with a puff of air, could cut out some
key hurdles to vaccination in resource-
poor parts of the world.
Reference
Fierce Vaccines: (Click Here)
7. Volume 5, Issue 12Page 2 Part II NORCB
Middle East respiratory syndrome coronavirus (MERS-CoV)
the National IHR Focal Point for the King-
dom of Saudi Arabia (KSA) notified WHO
of 11 additional cases of Middle East respir-
atory syndrome coronavirus (MERS-CoV)
infection, including 4 deaths.
WHO advice:Infection prevention and con-
trol measures are critical to prevent the pos-
sible spread of MERS-CoV in health care
facilities. It is not always possible to identify
patients with MERS-CoV early because like
other respiratory infections, the early symp-
toms of MERS-CoV are non-specific.
Therefore, health-care workers should al-
ways apply standard precautions consistent-
ly with all patients, regardless of their diag-
nosis. Droplet precautions should be added
to the standard precautions when providing
care to patients with symptoms of acute res-
piratory infection; contact precautions and
eye protection should be added when caring
for probable or confirmed cases of MERS-
CoV infection; airborne precautions should be applied
when performing aerosol generating procedures. Until
more is understood about MERS-CoV, people with dia-
betes, renal failure, chronic lung disease, and immuno-
compromised persons are considered to be at high risk
of severe disease from MERS‐CoV infection. Therefore,
these people should avoid close contact with animals,
particularly camels, when visiting farms, markets, or
barn areas where the virus is known to be potentially
circulating. General hygiene measures, such as regular
hand washing before and after touching animals and
avoiding contact with sick animals, should be adhered
to.
Reference
World Health Organization: (Click Here)
Breast cancer vaccine looks promising in early trial
the trial was undertaken to test the safety of
the vaccine, it showed that the vaccine slowed
cancer progression, even in patients with
weakened immune systems from advanced
cancer and exposure to chemotherapy. Based
on these preliminary results, the team at
Washington University is planning a larger
trial to test the vaccine in newly diag-
nosed breast cancer patients, who should have
stronger immune systems .
The vaccine causes the immune system to tar-
get a protein called mammoglobin-A, which is
found almost exclusively in breast tissue. In
response to the vaccine, a type of white blood
cell seeks and destroys cells that have the
mammoglobin-A protein. While the protein's func-
tion in healthy tissue is unclear, it is expressed in
abnormally high levels in up to 80% of breast tu-
mors. This means that the vaccine could potential-
ly be used to treat a large number of breast cancer
patients with fewer side effects.
Reference
Fierce Vaccines: (Click Here)
8. Volume 5, Issue 12 Part II NORCB Page 3
Universal dengue vaccine may be possible thanks to antibody discovery
Several recent clinical trials indicate that Gar-
dasil 9 is 97 percent effective in preventing peo-
ple from contracting vaginal, vulvar and cervical
cancers.
Previous Gardasil vaccines only protected
against five HPV strains and were limited to only
female recipients which protects against nine
strains, amounting to 90 percent of anal, vulvar,
vaginal and cervical cancers.
Despite these findings, the Center for the Biology
of Chronic Disease (CBCD) continues to recom-
mend natural HPV remedies, such as Gene-Eden
-VIR or Novirin, over the vaccine.
Gene-Eden-VIR and Novirin contain natural die-
tary supplements that are antiviral, such as Ca-
mellia Sinesis extract (a trace element), selenium,
Cinnamomum extract, quercetin and licorice ex-
tract.
PolyDNA, the company responsible for develop-
ing and patenting the natural treatments, exten-
sively researched thousands of medical and scien-
tific papers, journals and studies to find natural in-
gredients that safely and effectively protect against
latent viruses.
As of today, Gene-Eden-VIR and Novirin are the
only two natural products on the market with pub-
lished clinical studies that support their efficacy.
Reference
Vaccine news daily: (Click Here)
In findings published on Monday in Nature Immu-
nology, scientists studied 145 human antibodies
and found new ones that neutralize all four types
of dengue virus--including serotype 2 In 2012, a
company conducted a Phase IIb trial in Thailand
of its tetravalent dengue candidate, which success-
fully defended against serotypes 1, 3 and 4, but fal-
tered against serotype 2.
It didn't do much better in Phase III trials held this
year in Asia, posting a 35% efficacy in serotype 2,
just a little higher than the approximately 30% effi-
cacy it registered in the 2012 trial.
While results from a Phase III trial conducted in
Latin America showed improvement against sero-
type 2--42% efficacy--they still didn't come close to
the company’s initial estimate, which was more
than 70% efficacy.
Despite its lackluster performance against serotype
2, the vaccine, by blocking three out of the four
dengue viruses, lowered the overall risk of con-
tracting dengue as well as reduced hospitalization.
Following the announcement of the Latin Ameri-
can trial results, the company said it could have
the vaccine to market by the second half of 2015.
It could be the world's first dengue vaccine.
Reference
Fierce Vaccines: (Click Here)
FDA approves latest HPV vaccine
9. A call for reporting
Please remember that you can report suspected adverse
reaction of medicines to EPVC, and adverse reaction
following immunization to NORCB using the follow-
ing communication information
51 Wezaret El Zeraa Street, Agouza, Giza P.O. Box: 354 Dokki
Phone: +202 – 37 480 478 ext. 118
Fax: +202 – 37480472
Email: pmsdep@yahoo.com
National Organization for Research & Control of Biologicals
Post Marketing Surveillance and Adverse Event Following
immunization Department
21 Abd El Aziz Al Soud Street. El-Manial, Cairo, Egypt, PO Box: 11451
Phone: +202 – 23684288,
Fax: +202 – 23610497
Email: pv.center@eda.mohealth.gov.eg
Central Administration of Pharmaceutical Affairs
Egyptian Pharmaceutical Vigilance Center
Pharmacovigilance Department
www.epvc.gov.eg
Communications information
What is Pharmacovigilance
According to the WHO, Pharmacovigilance is
the science and activities relating to the de-
tection, assessment, understanding and pre-
vention of adverse effects or any other medi-
cine-related problem.
What is the Egyptian Pharmaceuti-
cal Vigilance Center
With the increasing demand for patient's
safety which is becoming more stringent, the
regulatory authorities are facing an in-
creased demand for patient welfare and
safety. Thus, The Egyptian Pharmaceutical
Vigilance Center (EPVC) is constructed within
The Central Administration of Pharmaceuti-
cal Affairs (CAPA) Ministry of Health to be
responsible for the collection and evaluation
of information on pharmaceutical products
marketed in Egypt with particular reference
to adverse reactions. Furthermore, EPVC is
taking all appropriate measures to:
1.Encourage physicians and other healthcare
professionals to report the suspected ad-
verse reactions to EPVC.
2.Necessitate the pharmaceutical compa-
nies to systematically collect information
on risks related to their medical products
and to transmit them to EPVC.
3.Provide information to end-users through
adverse drug reaction news bulletins, drug
alerts and seminars.