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.
This document provides a summary of developments in reproductive medicine presented by T. Cordes and K. Diedrich from the University of Schleswig-Holstein, Campus Lübeck, Germany. It discusses milestones from 1960 onward including IVF in 1970, cryopreservation in 1980, and ICSI in 1990. Newer developments discussed include the use of GnRH antagonists for ovarian stimulation, elective single embryo transfer to reduce multiple births, blastocyst culture, and preimplantation genetic screening. In-vitro maturation is presented as an alternative for certain patient groups. Cryopreservation methods such as vitrification are also summarized.
Post-partum hemorrhage (PPH) is a leading cause of maternal mortality worldwide, accounting for nearly one quarter of all maternal deaths. PPH can be primary (within 24 hours of delivery) or secondary (24 hours to 6 weeks after delivery). The main causes of PPH are uterine atony, trauma, retained tissue, and coagulation disorders. Early recognition and treatment are important to prevent mortality, as death can occur within 2 hours if untreated. Management involves active management of the third stage of labor with uterotonics like oxytocin, ergot alkaloids, carboprost, and misoprostol. If bleeding continues, additional measures may be needed like bimanual compression, internal uterine
to learn the side effects of drugs.
how to decrease the drugs when patient is on plant based natural diet.
Dr Paawan Wadhawan is a Diabetologist who reverses the diabetes with diet only.
This document discusses the role of anti-IL6 medications like tocilizumab in treating the cytokine storm seen in severe COVID-19 cases. It notes that cytokine storm can lead to multi-organ failure if left untreated. Tocilizumab works by inhibiting IL-6 receptors to mitigate the cytokine release syndrome. The document reviews several clinical trials that show tocilizumab may reduce mortality and decrease the need for mechanical ventilation in hospitalized COVID-19 patients experiencing severe pneumonia. It provides guidelines on patient selection, dosage, contraindications, and monitoring for safe administration of tocilizumab. The key takeaway is that anti-IL6 medications could benefit severe COVID-19 patients if given early before organ failure,
The British Islamic Medical Association recommends the COVID-19 Vaccine AstraZeneca for eligible individuals in the Muslim community for protection against COVID-19 when used in accordance with regulatory approval. They note efficacy was shown to be 70.42% with mostly mild adverse reactions reported. While vaccines are now available, vigilance with preventive measures like masks and distancing remain important given continued high transmission rates disproportionately impacting ethnic minorities.
Safety of neuraminidase inhibitors in pregnant and breastfeeding women tanaka...Ruth Vargas Gonzales
1) A new strain of influenza A virus (H1N1) emerged and spread rapidly globally, increasing concern as it disproportionately affected young people. Pregnant women are also at high risk.
2) The antiviral drugs oseltamivir and zanamivir are effective against the new H1N1 strain. Limited data suggests oseltamivir is unlikely to cause major birth defects, while even less is known about zanamivir's safety during pregnancy.
3) Both drugs are considered compatible with breastfeeding as levels transferred to breastmilk would be low. Continued breastfeeding is recommended even if the mother is being treated.
The document discusses the use of anti-inflammatory drugs to treat COVID-19. It explains that early in the infection, the disease is driven by viral replication, while later it is driven by an exaggerated immune response causing tissue damage. Anti-inflammatory therapies are likely more beneficial in later stages. Tocilizumab, an IL-6 inhibitor, is discussed as a potential treatment for its "cytokine storm". Studies on tocilizumab show mixed results, with some trials like REMAP-CAP showing reduced need for ventilation and others like COVACTA not meeting primary endpoints. The document provides dosage recommendations and warnings for tocilizumab use in COVID-19 patients.
This document discusses neurologic complications that can occur during pregnancy, including preeclampsia-eclampsia, hemolytic elevated liver enzyme levels and low platelet levels syndrome, and myasthenia gravis. Preeclampsia-eclampsia is a leading cause of maternal mortality and morbidity. Seizures are a hallmark of eclampsia. Magnesium sulfate is the primary treatment for preventing and treating seizures. Hemolytic elevated liver enzyme levels and low platelet levels syndrome is a severe form of preeclampsia associated with high mortality rates. Myasthenia gravis can worsen during pregnancy, especially in the first trimester and postpartum period. Careful monitoring and management is important for these
This document provides a summary of developments in reproductive medicine presented by T. Cordes and K. Diedrich from the University of Schleswig-Holstein, Campus Lübeck, Germany. It discusses milestones from 1960 onward including IVF in 1970, cryopreservation in 1980, and ICSI in 1990. Newer developments discussed include the use of GnRH antagonists for ovarian stimulation, elective single embryo transfer to reduce multiple births, blastocyst culture, and preimplantation genetic screening. In-vitro maturation is presented as an alternative for certain patient groups. Cryopreservation methods such as vitrification are also summarized.
Post-partum hemorrhage (PPH) is a leading cause of maternal mortality worldwide, accounting for nearly one quarter of all maternal deaths. PPH can be primary (within 24 hours of delivery) or secondary (24 hours to 6 weeks after delivery). The main causes of PPH are uterine atony, trauma, retained tissue, and coagulation disorders. Early recognition and treatment are important to prevent mortality, as death can occur within 2 hours if untreated. Management involves active management of the third stage of labor with uterotonics like oxytocin, ergot alkaloids, carboprost, and misoprostol. If bleeding continues, additional measures may be needed like bimanual compression, internal uterine
to learn the side effects of drugs.
how to decrease the drugs when patient is on plant based natural diet.
Dr Paawan Wadhawan is a Diabetologist who reverses the diabetes with diet only.
This document discusses the role of anti-IL6 medications like tocilizumab in treating the cytokine storm seen in severe COVID-19 cases. It notes that cytokine storm can lead to multi-organ failure if left untreated. Tocilizumab works by inhibiting IL-6 receptors to mitigate the cytokine release syndrome. The document reviews several clinical trials that show tocilizumab may reduce mortality and decrease the need for mechanical ventilation in hospitalized COVID-19 patients experiencing severe pneumonia. It provides guidelines on patient selection, dosage, contraindications, and monitoring for safe administration of tocilizumab. The key takeaway is that anti-IL6 medications could benefit severe COVID-19 patients if given early before organ failure,
The British Islamic Medical Association recommends the COVID-19 Vaccine AstraZeneca for eligible individuals in the Muslim community for protection against COVID-19 when used in accordance with regulatory approval. They note efficacy was shown to be 70.42% with mostly mild adverse reactions reported. While vaccines are now available, vigilance with preventive measures like masks and distancing remain important given continued high transmission rates disproportionately impacting ethnic minorities.
Safety of neuraminidase inhibitors in pregnant and breastfeeding women tanaka...Ruth Vargas Gonzales
1) A new strain of influenza A virus (H1N1) emerged and spread rapidly globally, increasing concern as it disproportionately affected young people. Pregnant women are also at high risk.
2) The antiviral drugs oseltamivir and zanamivir are effective against the new H1N1 strain. Limited data suggests oseltamivir is unlikely to cause major birth defects, while even less is known about zanamivir's safety during pregnancy.
3) Both drugs are considered compatible with breastfeeding as levels transferred to breastmilk would be low. Continued breastfeeding is recommended even if the mother is being treated.
The document discusses the use of anti-inflammatory drugs to treat COVID-19. It explains that early in the infection, the disease is driven by viral replication, while later it is driven by an exaggerated immune response causing tissue damage. Anti-inflammatory therapies are likely more beneficial in later stages. Tocilizumab, an IL-6 inhibitor, is discussed as a potential treatment for its "cytokine storm". Studies on tocilizumab show mixed results, with some trials like REMAP-CAP showing reduced need for ventilation and others like COVACTA not meeting primary endpoints. The document provides dosage recommendations and warnings for tocilizumab use in COVID-19 patients.
This document discusses neurologic complications that can occur during pregnancy, including preeclampsia-eclampsia, hemolytic elevated liver enzyme levels and low platelet levels syndrome, and myasthenia gravis. Preeclampsia-eclampsia is a leading cause of maternal mortality and morbidity. Seizures are a hallmark of eclampsia. Magnesium sulfate is the primary treatment for preventing and treating seizures. Hemolytic elevated liver enzyme levels and low platelet levels syndrome is a severe form of preeclampsia associated with high mortality rates. Myasthenia gravis can worsen during pregnancy, especially in the first trimester and postpartum period. Careful monitoring and management is important for these
This document discusses intrauterine fetal death (IUFD). It defines IUFD and notes its prevalence. Common causes are discussed including maternal, fetal, placental, and iatrogenic factors. Diagnosis involves decreased fetal movement, absent heart tones, ultrasound findings and tests. Management includes watchful expectancy or induction of labor. Induction is recommended for emotional and medical reasons. The risks of expectant management are outlined. Follow up after IUFD determines cause and counsels for future pregnancies. Prevention focuses on antenatal care, treatment of infections/risks, and patient education.
This document discusses induction of labor and provides definitions, objectives, indications, contraindications, risks, prerequisites, and methods of induction. It defines grades of evidence and levels of recommendations. The main methods discussed are natural/non-medical, mechanical (laminaria, balloons), surgical (stripping membranes, amniotomy), and pharmacological (misoprostol, mifepristone, oxytocin, prostaglandin E2). It provides details on administration and risks for each method. The goal is to create awareness of appropriate induction techniques and select the best method for each individual patient.
Multifetal pregnancies, especially those of higher order multiples, pose significant risks to both mother and fetuses. These risks include maternal complications such as preeclampsia and gestational diabetes as well as fetal complications like premature birth, low birth weight, and developmental impairments. Multifetal pregnancy reduction (MFPR) aims to reduce these risks by terminating one or more fetuses, leaving the remaining fetuses with improved health outcomes. While controversial, MFPR is generally considered ethically acceptable for reducing high order multiples and may provide benefits for triplet pregnancies. The procedure involves using ultrasound guidance to transvaginally inject a needle into the selected fetus between 7-12 weeks gestation.
MTP- Medical Termination Pregnancy word File sonal patel
This document discusses medical termination of pregnancy (MTP) in three paragraphs or less:
MTP can be performed through medical or surgical methods up to 20 weeks of pregnancy. Medical methods use pharmaceutical drugs like mifepristone and misoprostol to induce abortion. Surgical methods include vacuum aspiration and dilation and evacuation. Indications for MTP include risks to the physical or mental health of the woman, fetal abnormalities, or pregnancies caused by rape or contraceptive failure. Common medical protocols involve mifepristone followed by misoprostol 1-3 days later. Surgical methods like vacuum aspiration are also effective options, especially in early pregnancy. Mid-trimester termination often uses prostaglandin
Fungemia in the Setting of Acute Lymphocytic Leukemia (FINAL)-1Tamara Bystrak
A 6-year-old male with acute lymphocytic leukemia and febrile neutropenia was initially treated for streptococcal bacteremia. After a week, he developed disseminated fungal infection with Trichosporon species confirmed by culture. Voriconazole was started as it has the best activity against Trichosporon. Close monitoring with ultrasounds and therapeutic drug monitoring of voriconazole trough levels is needed due to its non-linear pharmacokinetics and potential for toxicity.
The document provides instructions for using the CoronaVac vaccine under an emergency use authorization in Indonesia. Key points include:
- CoronaVac is approved to induce immunity against SARS-CoV-2 and prevent COVID-19 for people aged 18 and older.
- The recommended administration is two 0.5 mL doses given intramuscularly in the deltoid muscle, with doses spaced 2 weeks or 4 weeks apart depending on the situation.
- Common adverse reactions reported in clinical trials were mild to moderate, including pain at the injection site and fatigue.
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Drug-induced priapism is a persistent penile erection lasting more than four hours that is not associated with sexual stimulation. It most commonly occurs with antipsychotic medications and requires immediate medical attention to prevent long-term complications. Patients prescribed medications known to cause priapism should be advised of the signs and symptoms. Some medications should not be removed from their original packaging, as this may impact the medication's effectiveness and safety due to exposure to heat, air, light, or moisture. Medication storage and handling precautions are important to follow in order to maintain proper medication stability and avoid potential adverse effects.
Anticoagulants help prevent blood clotting by interfering with the coagulation phase. Heparin is an indirect thrombin inhibitor that works by accelerating the inactivation of clotting factors. It is administered parenterally and monitored with aPTT. Warfarin is an oral anticoagulant that acts by inhibiting vitamin K dependent clotting factors and is monitored with PT/INR. Both can cause bleeding and have specific contraindications and protocols for use during procedures.
This document discusses drug use during pregnancy and lactation. It notes that drug use requires special consideration as both the mother and child are affected. During the first trimester, drugs can cause birth defects, and later in pregnancy they can impact fetal growth or development. The principles of therapy are to only use medications when clearly needed, starting with non-drug options, and using the lowest effective dose for shortest time. The document categorizes drugs from A to X based on safety in pregnancy, with Category X posing the greatest risk to the fetus. It also covers common pregnancy issues and medications that may be used to treat them.
The document discusses the management of post-partum haemorrhage (PPH). It defines PPH as blood loss greater than 1000 ml within 24 hours of birth. The main causes of PPH are uterine atony (70%), trauma (20%), retained tissue (10%), and coagulopathy (1%). Active management of the third stage of labour (AMTSL) including uterotonics, controlled cord traction, and uterine massage is recommended for prevention. For treatment, a haemostasis algorithm is followed involving assessment of blood loss, establishing etiology, massaging the uterus, administering oxytocics, and potential surgical interventions if needed. Urgent resuscitation and monitoring of vital signs is crucial for
Microlut is an oral contraceptive containing the progestogen levonorgestrel. It prevents pregnancy through changes to the cervical mucus and endometrium that inhibit sperm migration and implantation. While efficacy is slightly lower than combined oral contraceptives, correct usage results in a very low chance of pregnancy. Levonorgestrel is rapidly absorbed and has a half-life of about 20 hours. Microlut is contraindicated in pregnancy, venous thromboembolism, certain cardiovascular conditions, liver tumors, and breast cancer. Precautions include increased risks of circulatory disorders and rare neoplastic effects.
Dabigatran is a direct thrombin inhibitor approved for reducing risk of stroke in non-valvular atrial fibrillation and for preventing blood clots after orthopedic surgery. It is administered orally twice daily and has similar efficacy to warfarin but does not require routine monitoring. However, dabigatran has risks including lack of antidote, difficulty modulating dose, and bleeding in elderly or renally impaired patients. It was the first new oral anticoagulant approved in the United States in decades.
This document discusses transfusion of blood products and management of coagulation disorders in obstetrics. It provides information on fresh frozen plasma (FFP), cryoprecipitate, platelet concentrates, packed red blood cells (PRBC), recombinant factor VIIa, autotransfusion, alternative oxygen carriers, heparin, and fibrinolytic inhibitors. It emphasizes the importance of promptly replacing blood volume and coagulation factors in managing coagulation disorders during pregnancy and delivery.
The document discusses recurrent pregnancy loss (RPL), defined as 3 or more consecutive pregnancy losses before 20 weeks of gestation. It outlines various etiological factors that can cause RPL, including anatomical, endocrine, immunological, genetic, thrombophilic, and environmental factors. For evaluation and treatment, it recommends investigating common, treatable causes first such as uterine anomalies, thyroid disorders, antiphospholipid syndrome, and thrombophilias. Treatments discussed include surgery, medications, lifestyle changes, and assisted reproductive technologies.
This guideline provides recommendations for the management of gestational trophoblastic disease (GTD) and gestational trophoblastic neoplasia (GTN). It covers definitions, presentation, diagnosis, evacuation methods, and follow up of molar pregnancies. The definitive diagnosis of GTD requires histological examination. Suction curettage is recommended for evacuating complete molar pregnancies, while medical evacuation may be used for partial molar pregnancies if fetal parts prevent suction curettage. Follow up beta hCG testing and treatment is important to monitor for GTN.
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.
More Related Content
Similar to EPVC newsletter sixty one -february 2015
This document discusses intrauterine fetal death (IUFD). It defines IUFD and notes its prevalence. Common causes are discussed including maternal, fetal, placental, and iatrogenic factors. Diagnosis involves decreased fetal movement, absent heart tones, ultrasound findings and tests. Management includes watchful expectancy or induction of labor. Induction is recommended for emotional and medical reasons. The risks of expectant management are outlined. Follow up after IUFD determines cause and counsels for future pregnancies. Prevention focuses on antenatal care, treatment of infections/risks, and patient education.
This document discusses induction of labor and provides definitions, objectives, indications, contraindications, risks, prerequisites, and methods of induction. It defines grades of evidence and levels of recommendations. The main methods discussed are natural/non-medical, mechanical (laminaria, balloons), surgical (stripping membranes, amniotomy), and pharmacological (misoprostol, mifepristone, oxytocin, prostaglandin E2). It provides details on administration and risks for each method. The goal is to create awareness of appropriate induction techniques and select the best method for each individual patient.
Multifetal pregnancies, especially those of higher order multiples, pose significant risks to both mother and fetuses. These risks include maternal complications such as preeclampsia and gestational diabetes as well as fetal complications like premature birth, low birth weight, and developmental impairments. Multifetal pregnancy reduction (MFPR) aims to reduce these risks by terminating one or more fetuses, leaving the remaining fetuses with improved health outcomes. While controversial, MFPR is generally considered ethically acceptable for reducing high order multiples and may provide benefits for triplet pregnancies. The procedure involves using ultrasound guidance to transvaginally inject a needle into the selected fetus between 7-12 weeks gestation.
MTP- Medical Termination Pregnancy word File sonal patel
This document discusses medical termination of pregnancy (MTP) in three paragraphs or less:
MTP can be performed through medical or surgical methods up to 20 weeks of pregnancy. Medical methods use pharmaceutical drugs like mifepristone and misoprostol to induce abortion. Surgical methods include vacuum aspiration and dilation and evacuation. Indications for MTP include risks to the physical or mental health of the woman, fetal abnormalities, or pregnancies caused by rape or contraceptive failure. Common medical protocols involve mifepristone followed by misoprostol 1-3 days later. Surgical methods like vacuum aspiration are also effective options, especially in early pregnancy. Mid-trimester termination often uses prostaglandin
Fungemia in the Setting of Acute Lymphocytic Leukemia (FINAL)-1Tamara Bystrak
A 6-year-old male with acute lymphocytic leukemia and febrile neutropenia was initially treated for streptococcal bacteremia. After a week, he developed disseminated fungal infection with Trichosporon species confirmed by culture. Voriconazole was started as it has the best activity against Trichosporon. Close monitoring with ultrasounds and therapeutic drug monitoring of voriconazole trough levels is needed due to its non-linear pharmacokinetics and potential for toxicity.
The document provides instructions for using the CoronaVac vaccine under an emergency use authorization in Indonesia. Key points include:
- CoronaVac is approved to induce immunity against SARS-CoV-2 and prevent COVID-19 for people aged 18 and older.
- The recommended administration is two 0.5 mL doses given intramuscularly in the deltoid muscle, with doses spaced 2 weeks or 4 weeks apart depending on the situation.
- Common adverse reactions reported in clinical trials were mild to moderate, including pain at the injection site and fatigue.
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Drug-induced priapism is a persistent penile erection lasting more than four hours that is not associated with sexual stimulation. It most commonly occurs with antipsychotic medications and requires immediate medical attention to prevent long-term complications. Patients prescribed medications known to cause priapism should be advised of the signs and symptoms. Some medications should not be removed from their original packaging, as this may impact the medication's effectiveness and safety due to exposure to heat, air, light, or moisture. Medication storage and handling precautions are important to follow in order to maintain proper medication stability and avoid potential adverse effects.
Anticoagulants help prevent blood clotting by interfering with the coagulation phase. Heparin is an indirect thrombin inhibitor that works by accelerating the inactivation of clotting factors. It is administered parenterally and monitored with aPTT. Warfarin is an oral anticoagulant that acts by inhibiting vitamin K dependent clotting factors and is monitored with PT/INR. Both can cause bleeding and have specific contraindications and protocols for use during procedures.
This document discusses drug use during pregnancy and lactation. It notes that drug use requires special consideration as both the mother and child are affected. During the first trimester, drugs can cause birth defects, and later in pregnancy they can impact fetal growth or development. The principles of therapy are to only use medications when clearly needed, starting with non-drug options, and using the lowest effective dose for shortest time. The document categorizes drugs from A to X based on safety in pregnancy, with Category X posing the greatest risk to the fetus. It also covers common pregnancy issues and medications that may be used to treat them.
The document discusses the management of post-partum haemorrhage (PPH). It defines PPH as blood loss greater than 1000 ml within 24 hours of birth. The main causes of PPH are uterine atony (70%), trauma (20%), retained tissue (10%), and coagulopathy (1%). Active management of the third stage of labour (AMTSL) including uterotonics, controlled cord traction, and uterine massage is recommended for prevention. For treatment, a haemostasis algorithm is followed involving assessment of blood loss, establishing etiology, massaging the uterus, administering oxytocics, and potential surgical interventions if needed. Urgent resuscitation and monitoring of vital signs is crucial for
Microlut is an oral contraceptive containing the progestogen levonorgestrel. It prevents pregnancy through changes to the cervical mucus and endometrium that inhibit sperm migration and implantation. While efficacy is slightly lower than combined oral contraceptives, correct usage results in a very low chance of pregnancy. Levonorgestrel is rapidly absorbed and has a half-life of about 20 hours. Microlut is contraindicated in pregnancy, venous thromboembolism, certain cardiovascular conditions, liver tumors, and breast cancer. Precautions include increased risks of circulatory disorders and rare neoplastic effects.
Dabigatran is a direct thrombin inhibitor approved for reducing risk of stroke in non-valvular atrial fibrillation and for preventing blood clots after orthopedic surgery. It is administered orally twice daily and has similar efficacy to warfarin but does not require routine monitoring. However, dabigatran has risks including lack of antidote, difficulty modulating dose, and bleeding in elderly or renally impaired patients. It was the first new oral anticoagulant approved in the United States in decades.
This document discusses transfusion of blood products and management of coagulation disorders in obstetrics. It provides information on fresh frozen plasma (FFP), cryoprecipitate, platelet concentrates, packed red blood cells (PRBC), recombinant factor VIIa, autotransfusion, alternative oxygen carriers, heparin, and fibrinolytic inhibitors. It emphasizes the importance of promptly replacing blood volume and coagulation factors in managing coagulation disorders during pregnancy and delivery.
The document discusses recurrent pregnancy loss (RPL), defined as 3 or more consecutive pregnancy losses before 20 weeks of gestation. It outlines various etiological factors that can cause RPL, including anatomical, endocrine, immunological, genetic, thrombophilic, and environmental factors. For evaluation and treatment, it recommends investigating common, treatable causes first such as uterine anomalies, thyroid disorders, antiphospholipid syndrome, and thrombophilias. Treatments discussed include surgery, medications, lifestyle changes, and assisted reproductive technologies.
This guideline provides recommendations for the management of gestational trophoblastic disease (GTD) and gestational trophoblastic neoplasia (GTN). It covers definitions, presentation, diagnosis, evacuation methods, and follow up of molar pregnancies. The definitive diagnosis of GTD requires histological examination. Suction curettage is recommended for evacuating complete molar pregnancies, while medical evacuation may be used for partial molar pregnancies if fetal parts prevent suction curettage. Follow up beta hCG testing and treatment is important to monitor for GTN.
Similar to EPVC newsletter sixty one -february 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.
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.
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.
Our backs are like superheroes, holding us up and helping us move around. But sometimes, even superheroes can get hurt. That’s where slip discs come in.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
TEST BANK For Community and Public Health Nursing: Evidence for Practice, 3rd...Donc Test
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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
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
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.
Cell Therapy Expansion and Challenges in Autoimmune Disease
EPVC newsletter sixty one -february 2015
1. Part I of II
EPVC Newsletter
Egyptian
Pharmaceutical
Vigilance Center
(EPVC)
Pharmacovigilance
Department
Inside this issue:
E p i d e m i o l o g y
Training organized
by EPVC
1
Solgar ABC Dophi-
lus Powder: Recall -
Risk of Infection
1
Nitrofurantoin -
Case Of Abortion
Due To Maternal
Exposure During
Pregnancy In Cairo
2
Levoxin - Case of
QT Prolongation
with a History of
Hypokalemia in
Cairo
3
Ziprasidone Drug
safety communica-
tion-Rare but po-
tentially fatal skin
Reactions
5
Volume 6, Issue 2February 2015
Epidemiology Training organized by EPVC
Kindly note that ABC Dophilus is not
registered in Egypt, however; because
some batches are illegally imported
and distributed against law, the
Pharmacovigilance department recom-
mended informing the public with this
safety information through this news-
letter.
This recommendation is based on
the FDA announcement on
11/17/2014 that Solgar, Inc. is vol-
untarily recalling Solgar ABC Doph-
ilus Powder. Testing conducted by
the Centers for Disease Control re-
vealed the presence of Rhizopus
oryzae in 50 g containers of Solgar
ABC Dophilus Powder, which may
cause Mucormycosis. This is a rare
infection that may cause health prob-
lems to consumers, particularly pre-
mature infants/infants, children,
and those with weakened immune
systems. It may also occur rarely in
people who are otherwise healthy.
Mucormycosis is any fungal infec-
tion caused by fungi in the or-
der Mucorales. Generally, species in
the Mucor, Rhizopus,Absidia,
and Cunninghamella genera are
most often implicated.
This disease is often characterized
Solgar ABC Dophilus Powder: Recall - Risk of
Infection
At the interval from 20 to 22 Janu-
ary, the Egyptian Pharmaceutical
vigilance center (EPVC) conducted
an epidemiology training under the
umbrella of AUPAM (Arab Union
of the Manufacturers of Pharmaceu-
ticals and Medical Appliances) and
Arab League and was attended by 48
attendees.
The covered topics in this workshop
were:
• Principles of Pharmacoepidemiolo-
gy
• Appropriate Literature Review
• Systematic Review and Meta-
analysis
• Evidence Based Medicine
• Study designs
• Essential Statistics for the Pharma-
ceutical Sciences
• Evidence Based Medicine in Phar-
macy Practice
2. Volume 6, Issue 2Page 2 Part I EPVC
by hyphae growing in and around vessels.
Risk factors for developing Mucormycosis include: uncontrolled diabetes; cancer; organ transplant;
neutropenia (low white blood cells); skin trauma (cuts, scrapes, punctures, or burns).
Product recalled has UPC Code: 0 33984 00010 0; Lot# 074024-01R1, 074024-01, 074024-02; Expira-
tion Date 7/31/15
RECOMMENDATION: Do not consume this product. Susceptible consumers should consult with
their physician or health care provider if they have used this product.
It is important to mention that the Ministry of health at Australia is working to stop future shipments of
affected batches of Solgar ABC Dophilus powder from entering the country.
References
1. FDA safety alert (Click here)
2. Recall firm press release (Click here)
3. TGA safety information (Click here)
The regional center in Cairo received an ICSR
concerning a thirty years old pregnant female,
with a history of threatened abortion, who re-
ceived Nitrofurantoin 100 mg (one tablet every
12 hours) during the third month of pregnancy
as per her physician’s prescription. This led to
Abortion.
Background:
Nitrofurantioin is used for the treatment of and
prophylaxis against acute of recurrent, uncom-
plicated lower urinary tract infections or pyelitis
either spontaneous or following surgical proce-
dures. (1)
Animal studies with Nitrofurantoin have shown
no teratogenic effects. Nitrofurantoin has been
in extensive clinical use since 1952 and its suita-
bility in human pregnancy has been well docu-
mented. However as with all drugs, the maternal
side effects may adversely affect the course of
pregnancy. The drug should be used at the low-
est dose appropriate for the specific indication,
only after careful assessment. (1)
Nitrofurantoin - Case Of Abortion Due To Maternal Exposure During
Pregnancy In Cairo
Urinary tract infections are among the most com-
mon bacterial infections during pregnancy due to
hormonal and mechanical changes. (2)
Labeled information:
According to Nitrofurantoin Summary of prod-
uct Characteristics (SmPC)(1)
it was stated under
section (4.3 Contraindications) that: “In infants
under three months of age as well as pregnant
patients at term (during labour and delivery) be-
cause of the theoretical possibility of haemolytic
anaemia in the foetus or in the new-born infant,
due to immature erythrocyte enzyme systems.” (1)
According to Nitrofurantoin (PIL) it was stated
under section (Contraindications) that:
“Caution is indicated in any impairment of excretion
and during the first three months of pregnancy.”
However in this case, with a history of threat-
ened abortion, Nitrofurantoin caused severe ab-
dominal pain and vaginal bleeding after the first
tablet then spontaneous abortion after the second
tablet.
3. Volume 6, Issue 2Page 3 Part I EPVC
The regional center in Cairo received an ICSR
concerning a fifty years old female that received
Levofloxacin 500 mg IV (Once daily) for
COPD, and Potassium Chloride 15% (W/V) IV
(Once daily) for hypokalemia as per her physi-
cian’s prescription. This led to QT Prolonga-
tion.
Background:
Some fluoroquinolones, including Levofloxa-
cin, have been associated with prolongation of
the QT interval on the electrocardiogram
Levoxin - Case of QT Prolongation with a History of Hypokalemia in
Cairo
"ECG" and infrequent cases of arrhythmia. (1)
Rare cases of torsade de pointes have been spon-
taneously reported during postmarketing surveil-
lance in patients receiving fluoroquinolones, in-
cluding Levofloxacin. (1)
Levofloxacin should be avoided in patients with
known prolongation of the QT interval, patients
with uncorrected hypokalemia, and patients re-
ceiving Class IA (quinidine, procainamide), or
Class III (amiodarone, sotalol) antiarrhythmic
agents. (1)
Another case with a history of threatened abor-
tion was reported previously in a study in 1956
of 11 pregnant women, nausea and vomiting
occurred in five of the pregnant patients. One
patient with a previous diagnosis of threatened
abortion had fetal loss after 1 day of Nitrofu-
rantoin therapy. (3)
By searching the UMC database (VigiLyze),
the following was found:
Nitrofurantoin caused 15 cases of abortion, 11
cases of miscarriage, and 9 cases of premature
labor.
Recommendations for Healthcare Profession-
als:
Nitrofurantoin has been assigned to be catego-
ry B in pregnancy by the FDA, but: Nitrofu-
rantoin should be used at the lowest dose as
appropriate only after careful assessment, due
to the following:
a. The risk of “Spontaneous Abortion” if the preg-
nant woman had a medical history of threat-
ened abortion.
b. The possibility of hemolytic anemia in neonates
and children under 3 months due to immature
erythrocyte enzyme systems (glutathione instabil-
ity). So:
Nitrofurantoin is contraindicated in the first 6
months of pregnancy and during the last 4
weeks before the expected date.
Nitrofurantoin is contraindicated in pregnant
patients at term (during labour and delivery),
infants under three months of age and when
breast feeding
References:
1. MHRA Medicines and Healthcare Products Reg-
ulatory Agency. Nitrofurantoin SmPC [cited 26
January 2015]. (Click Here)
2. Emedicine.medscape.com. [cited 26 January
2015]. (Click Here)
3. DIGGS ES e. - PubMed - NCBI [cited 26 Janu-
ary 2015]. (Click Here)
4. Volume 6, Issue 2Page 4 Part I EPVC
Elderly patients may be more susceptible to drug-associated effects on the QT interval. (1)
The QT interval is the time between onset of ventricular depolarization and end of ventricular repolari-
zation. (2)
Other possible causes of prolonged QT interval include: MI, myocarditis, hypocalcemia, hypokalemia,
hypomagnesemia, hypothyroidism, subarachnoid or intracerebral hemorrhage, stroke, congenital long
QT syndrome, antiarrhythmics, tricyclic antidepressants, phenothiazines, other drugs. (2)
Labeled information:
According to Levofloxacin Summary of product Characteristics (SmPC) (3)
it was stated under section (4.4
Special warnings and precautions for use) that: Caution should be taken when using fluoroquinolones,
including levofloxacin in patients with known risk factors for prolongation of the QT interval such as, for
example:
congenital long QT syndrome
concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhyth-
mics, tricyclic antidepressants, macrolides, antipsychotics)
uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia)
cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)
Elderly patients and women may be more sensitive to QTc-prolonging medications. Therefore, caution
should be taken when using fluoroquinolones, including levofloxacin, in these populations. (3)
Recommendations for Healthcare Professionals:
Do NOT use levofloxacin if there is:
Uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia):
Hypokalemia must be corrected first. Monitor potassium level to avoid such serious Medication Error that led to
QT prolongation in this case. N.B: Normal adult serum potassium level is (3.5 - 5.2 mmol/L). (3, 4)
Cardiac disease (e.g. heart failure, myocardial infarction, bradycardia), or cardiac disorder (e.g. congenital long
QT syndrome).(3, 5)
Certain type of irregular heartbeat (QT prolongation, long QT syndrome) or low blood potassium levels. (5)
History of myasthenia gravis. (5)
Elderly patients and women may be more sensitive to fluoroquinolones related QTc-prolongation. (3)
Patients receiving drugs known to prolong the QT interval (e.g class IA and III antiarrhythmics, tricyclic antide-
pressants, macrolides, antipsychotics). (3)
Allergy to any ingredient in levofloxacin or to any other quinolone antibiotic (e.g., ciprofloxacin). (5)
References:
1. Drugs.com. Levofloxacin (Click Here)
2. Merckmanuals.com. [cited 28 January 2015]. (Click Here)
3. Medicines.org.uk. [cited 28 January 2015]. (Click Here)
4. Webmd.com. [cited 28 January 2015]. (Click Here)
5. Drugs.com. [cited 28 January 2015]. (Click Here)
5. Volume 6, Issue 2Page 5 Part I EPVC
Ziprasidone is an atypical antipsychot-
ic approved by the U.S. Food and Drug Admin-
istration (FDA) for the treatment of schizophre-
nia, and acute mania and mixed states associated
with bipolar disorder. Its intramuscular injection
form is approved for acute agitation in schizo-
phrenic patients for whom treatment with just
ziprasidone is appropriate. Ziprasidone is also
used off-labelfor depression, bipolar mainte-
nance, mood disorders, anxiety, aggression, de-
mentia, attention deficit hyperactivity disor-
der,obsessive compulsive disorder, autism,
and post-traumatic stress disorder.
On 11/12/2014 FDA warned that the antipsy-
chotic drug ziprasidone (marketed under the
brand name, Geodon, and its generics) is associ-
ated with a rare but serious skin reaction that can
progress to affect other parts of the body. A new
warning has been added to the Geodon drug la-
bel to describe the serious condition known as
Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS).
DRESS may start as a rash that can spread to all
parts of the body. It can include fever, swollen
lymph nodes, and inflammation of organs such
as the liver, kidney, lungs, heart, or pancreas.
DRESS also causes a higher-than-normal num-
ber of a particular type of white blood cell called
eosinophils in the blood. DRESS can lead to
death.
FDA reviewed information from six patients in
whom the signs and symptoms of DRESS ap-
peared between 11 and 30 days after ziprasidone
treatment was started.
None of these patients died.
Based on this information, FDA required the
manufacturer of Geodon to add a new warning
for DRESS to the Warnings and Precautions sec-
tion of the drug labels for the capsule, oral sus-
pension, and injection formulations.
RECOMMENDATIONS:
Treatment with ziprasidone may cause you
to have a rash. The rash can be severe, cover-
ing much of the body. You may also have a
fever and other symptoms associated with a
serious condition known as Drug Reaction
with Eosinophilia and Systemic Symptoms
(DRESS).
Call your health care professional(s) and seek
immediate care if you develop any of the fol-
lowing signs or symptoms:
Skin rash
Fever
Swollen face
Swollen lymph glands
For ziprasidone to work properly, it should be
taken every day as prescribed.
Do not stop taking ziprasidone or change your
dose without first talking to your health care
professional.
Discuss any questions or concerns about
ziprasidone with your health care professional.
References
1. FDA article published on 11/12/2014 (Click here)
2. FDA Drug Safety Communication (Click here)
Ziprasidone Drug safety communication-Rare but potentially fatal skin
Reactions
6. Inhalable vaccines for lung diseases on the horizon
National Organization
for Research &
Control of Biologicals
Post Marketing
Surveillance and
Adverse Event
Following
immunization
Department
Inside this issue:
Inhalable vaccines for
lung diseases on the
horizon
1
Vaccine testing for inop-
erable pancreatic cancer
1
New research shows HPV
vaccine not a cause for
MS
2
Shingles vaccine shows
promise in test subjects
age 50 and older
2
New antiretroviral drug
shows promise as HIV
vaccine
3
Ebola treatments could
be affected by virus
mutations
3
NORCB Newsletter
Volume 6 , Issue 1January 2015
Researchers at the University of North
Carolina at Chapel Hill and North Car-
olina State University recently discov-
ered a unique approach to creating in-
halable vaccines for pneumonia and
influenza. The vaccines are made using
nanoparticles and also show promise
for curing lung-specific diseases, in-
cluding tuberculosis.
When delivered through the lungs, par-
ticles with a positive surface charge
were shown to elicit antibody respons-
es, both in the lung and in the body.
By contrast, negatively charged parti-
cles of the same composition led to
weaker immune responses and in some
cases, undetectable immune responses.
This suggests that particle charge is an
important consideration in pulmonary
vaccination.
Reference
Vaccine news daily : (Click Here)
A biopharmaceutical oncology com-
pany based in Norway, recently re-
cruited 18 patients with inoperable
pancreatic cancer for the Phase I/II
clinical trial of its TG01 vaccine.
The CT TG01-01 trial is testing the
efficacy and safety of combining TG01
with chemotherapy to treat nonopera-
ble pancreatic cancer.
TG01 is a leading candidate for pan-
creatic cancer treatments. Researchers
believe it teaches the body’s immune
system to detect and destroy cancer
cells that show RAS mutations, one of
the first signs of a normal cell becom-
ing cancerous.
Vaccine testing for inoperable pancreatic cancer
The company will present interim re-
sults for the study during the first quar-
ter of 2016, with final results due in
the second quarter of 2017.
Reference
Vaccine news daily : (Click Here)
7. Volume 6, Issue 1Page 2 Part II NORCB
New research shows HPV vaccine not a cause for MS
Some research has linked the human papilloma-
virus vaccination (HPV) to the development of
multiple sclerosis (MS), but a recent study in
Scandinavia shows this isn’t the case.
The findings, found that girls and women ages
10 to 44 who received the HPV vaccination in
Sweden and Denmark had no increased risk for
MS or other central nervous system disorders.
The study conducted between 2006 and 2013 a
total of 3,983,824 girls and women were eligible
for inclusion in the study group. Of those,
789,082 were vaccinated during the study period
with a total of 1,927,581 quadrivalent human
papillomavirus (qHPV) vaccine doses.
During the follow-up process, 4,322 MS cases
and 3,300 cases of other central nervous system
diseases were discovered, but the researchers
determined that the qHPV vaccine was not the
cause.
Since the approval and licensure of the qHPV
vaccine in 2006, and the subsequent approval and
licensure of the bivalent HPV vaccine, more than
175 million doses have been distributed globally.
“These findings do not support concerns about a
causal relationship between qHPV vaccination and
demyelinating diseases.”
Reference
Vaccine news daily : (Click Here)
Shingles vaccine shows promise in test subjects age 50 and older
A new vaccine has been created that in a re-
cent Zoster Efficacy study demonstrated the
ability to reduce shingles in people 50 and
older .
The Zoster Efficacy study, which started in
August 2010 and was conducted with more
than 16,000 adult participants age 50 and
over, remains ongoing in 18 countries. Re-
sults of the study showed that during the
four years of the study, the new vaccine HZ/
su reduced the risk of shingles by 97.2 per-
cent compared with a placebo.
This candidate vaccine may offer an im-
portant option for the prevention of shingles,
a painful disease that negatively impacts health and
quality of life.
Reference
Vaccine news daily : (Click Here)
8. Volume 6, Issue 1Part II NORCBPage 3
New antiretroviral drug shows promise as HIV vaccine
HIV researchers hope the new antiretroviral drug,
can make dosing easier for some because the drug
would be administered by injection once every
three months. A clinical trial looking at the safety
and efficacy already has started at several U.S.
labs.
Antiretroviral drugs can interfere with HIV’s abil-
ity to duplicate itself using host cells and are used
to treat HIV infections or to prevent those at high
risk from acquiring the virus initially.
Ebola treatments could be affected by virus mutations
Reference
(Click Here)Vaccine news daily :
A recent study identified genetic mutations in the
strain of Ebola virus behind the current outbreak
in West Africa that could hinder potential se-
quence-based treatment options.
The research dates back four decades and traces
the genetic mutations that have taken place in the
virus. The findings conclude experimental, se-
quence-based therapeutic treatments could possi-
bly be affected due to changes in the composition
of the strain
A number of drugs currently being developed to
combat Ebola bind to and target a segment of the
genetic or protein sequence of the virus. The
drugs may not be as effective if the sequence
changes because of genetic drift.
The study compared the complete genomic se-
quence of the current outbreak strain EBOV/Mak
with the EBOV/Yam-May alternation from an
outbreak in Yambuku, Zaire, in 1976 and the
EBOV/Kik-9510621 strain from an outbreak in
Kikwit, Zaire, in 1995. Research revealed single
nucleotide polymorphisms in more than 600
spots, or roughly 3 percent of the genome.
Research was confined to those mutations that
altered the genetic sequences. Ten new mutations
were discovered that interfere with the actions of
monoclonal antibody, siRNA (small-interfering
RNA) or PMO (phosphorodiamidate morpholino
oligomer) drugs that are currently in the testing
phase.
Reference
Vaccine news daily : (Click Here)
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.