أولاً: التوعية الدوائية:
| Content | Issue date | Issue |
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Safety Notification Uterine bleeding in people taking oral anticoagulant therapy 1 |
03/2024 |
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Safety Notification ! Infusion-related |
02/2024 |
(169) Newsletter-Hundred Sixty nine
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Safety Notification ! Infusion-related |
01/2024 |
(168) Newsletter-Hundred Sixty eight
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Safety Notification ! : Antidepressant |
12/2023 | |
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Safety Alert ! : Vanishing bile duct |
11/2023 | |
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Safety Alert ! : Fluoroquinolone antibiotics: suicidal thoughts and behavior 1 |
10/2023 | |
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Local Alert: Sub-standardized and |
09/2023 | |
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Local Alert: Sub-standardized and |
08/2023 | |
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Direct-acting oral anticoagulants "Ca acetate caused muscle cramps to a fifth degree kidney failure patient compared to Ca carbonate being used as a phosphate binder " 2-3-4 EPVC News 5 EPVC Tips 6 |
07/2023 | |
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Emerging Safety Issue: Statin potential risks of myasthenia gravis and ocular myasthenia EPVC News EPVC Tips |
06/2023 | |
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Safety Alert : Buproprion: unmasking of Brugada syndrome Aflibercept induced endophthalmitis Two cases from Cairo : Atracurium EPVC News EPVC Tips |
05/2023 | |
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Consumer Update : Clopidogrel has EPVC Investigation reports (2): Pipazetate Two case reports from Alexandria: two EPVC News EPVC Tips |
04/2023 | |
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Alert: Darzalex , Napizole Counterfeit DHPC: Levothyroxine containing laboratory tests Case report from Cairo: Isotretinoin causing depression, skin dryness EPVC News EPVC Tips |
03/2023 |
(158) Newsletter-Hundred fifty eight
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Alert: Voltaren & Linezolid Counterfeit DHPC: Hydroxyethyl Starch Solution for Infusion– Reminder of Safety Measures to Minimize Risk Local Case Report: Insulin - lack EPVC News EPVC Tips |
02/2023 | |
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Alert: Averzolid, Restylane & Fortum Counterfeit |
01/2023 | |
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Alert: Omnevore & Pedicort |
12/2022 |
(155) Newsletter-Hundred fifty five
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Alert: Nexium & Vigamox
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11/2022 | |
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Alert: Nevanac & Dyspot Counterfiet DHPC: Dexmedetomidine -Increased Risk of Mortality in Intensive Care Unit |
10/2022 | |
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Counterfeit and Commercial Fraud 1 (DHPC): Colchicine Serious Poisoning – Reminder of the Rules of Proper Use Local Case Report: Tigecycline - Medication Error Medical Device: Dermal Filler Do's and Don'ts |
09/2022 | |
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Infliximab- Use of Live Vaccines in Infants Exposed in Utero or During Breastfeeding Local Case Report: Cefotaxime - Anaphylactic shock, Hypersensitivity, Hypoxia and Rash |
08/2022 | |
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•Citalopram & Escitalopram - Risk of Dosedependent Qt interval prolongation 1 •Local Case Report: Isotretinoin - Case of Skin rash, dryness and Blurred vision 2 |
07/2022 | |
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• Injectable Trime-butine- Risk of Cardiac Tox-icity in the Event of Misuse •Local Case Report: Pheno-barbital - Case of Apnea |
06/2022 | |
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• Alert: Xoraxone Vial Counterfeit 1 • Bone marrow suppression with methotrexate and trimethoprim or trimethoprim with sulfamethoxazole 2 • Local Case Report: Ceftriaxone with ketorolac - Anaphylactic shock 3 |
05/2022 |
(148) Newsletter-Hundred forty-eight May 2022
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4/2022 | |
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3/2022 | |
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2/2022 | |
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1/2022 | |
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12/2021 | |
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11/2021 | |
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10/2021 | (141) Newsletter-Hundred Forty One October 2021 |
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09/2021 | (140) Newsletter-Hundred Forty September 2021 |
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08/2021 | (139) Newsletter-Hundred Thirty-nine August 2021 |
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07/2021 | |
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06/2021 | |
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05/2021 | |
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04/2021 | |
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03/2021 | |
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02/2021 | |
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01/2021 |
ثانياً: خطابات موجهة لمقدمى الخدمات الصحية:
| Content | Issue date | Issue |
|
Cefuroxime - Clarification related to instructions for use |
Mar-2024 | DHPC -Cefuroxime |
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Topiramate :New restrictions to prevent exposure during pregnancy |
Jan-2024 | DHPC - Topiramate |
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Valproate: Potential risk to children of fathers treated with valproate - Updated |
Jan-2024 | DHPC - Valproate |
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SIMULECT ® (basiliximab): Supply of Simulect 20mg packs containing only basiliximab |
Dec-2023 | DHPC - Simulect |
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Linezolid, Averozolid Solution for IV infusion, clarification of yellow color appearance |
Dec-2023 | DHPC- Linezolid |
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Azithromycine: Reminder of risk of QT prolongation and method of IV preparation |
Dec-2023 | DHPC -Azithromycin |
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Ramucirumab: New safety label updates in Cyramza “Ramucirumab” Patient insert |
Dec-2023 | DHPC - Cyramza |
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Direct Healthcare Professional Communication (DHPC) for the Water for Injection(WFI) |
Oct-2023 | DHPC -Simulect |
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Potential Missing Package Leaflet in Folding Boxes of Hemlibra (emicizumab) 30mg/ml and |
Oct-2023 | DHPC- Hemlibra |
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Potential Missing Package Leaflet in Folding Boxes of Perjeta (pertuzumab), Kadcyla |
Oct-2023 | DHPC -perjeta |
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Potential Missing Package Leaflet in Folding Boxes of Mabthera S.C. 1400 MG/11.7 ML |
Oct-2023 | DHPC- Mabthera |
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Ketamine: prolonged use leads to serious hepatic and uro-nephrological damage |
Oct-2023 | DHPC- Ketamine |
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Clomiphene: risk of serious visual disturbances (blindness) |
Oct-2023 | |
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Lamotrigine: reminder of proper use in order to limit the risk of serious skin rash, |
Oct-2023 | |
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Pholcodine - The use of pholcodine in the 12 months before general anesthesia with |
Sep-2023 | |
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Acefylline Piperazine +Phenobarbital /Acefylline Piperazine +Phenobarbitone |
Sep-2023 | |
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Terbutaline Turbuhaler and Terbutaline nebulizer: important information to convey |
Sep-2023 | |
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Lung Surfactants< Product Name>, follow-up the safety and efficacy of the |
Sep-2023 | |
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Propofol: risk of sepsis when withdrawn multiple times from one container |
Aug-2023 | |
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Metamizole Sodium |
july-2023 | |
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Calcium Gluconate < Product Name> potential risk of underdosing with calcium |
july-2023 | |
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Systemic and inhaled fluoroquinolone antibiotics – reminder on restrictions of use |
july-2023 | |
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Darzalex (Daratumumab): “Interaction with Blood Compatibility Testing- Information for Blood |
Jun-2023 | |
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VINORELBINE, NAVELBINE 50MG/5ML & 10MG/1ML SOLUTION FOR |
MAY/2023 | |
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An Approved Safety Label Change: Risk Of Cushing’s Syndrome And Adrenal |
MAY/2023 | |
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Direct Healthcare Professional Communication for Lucentis® (Ranibizumab) |
MAY/2023 | |
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Yervoy (Ipilimumab) Notification of Pack Deviation from Egypt Specific Pack to |
Apr-2023 | |
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Desflurane, SUPRANE, Introduction of 2 warnings in the updated leaflet |
Feb-2023 | |
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Levothyroxine containing products: Biotin interference with laboratory tests |
Feb-2023 | |
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Terlipressin: Serious or fatal respiratory failure and sepsis/septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS) |
Jan/2023 | |
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Olaparib - For Treatment of Adult Patients with Deleterious or Suspected |
Jan/2023 | |
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Risk of exaggerated hypotension with rapid bolus administration of Vancomycin |
Dec/2022 | |
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Human Insulin – Differences between the old leaflet and the approved current |
Dec/2022 | |
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Hydroxyethyl Starch Solution for Infusion– Reminder of Safety Measures to |
Dec/2022 | |
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Ceftriaxone – Reminder of Precautions to Minimize Severe Hypersensitivity |
Dec/2022 | |
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Onasemnogene Abeparvovec - Risk for Thrombotic Microangiopathy |
Dec/2022 | |
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Cefotaxime – Reminder of Precautions to Minimize Severe Hypersensitivity |
Dec/2022 |
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Metamizole may reduce the effect of acetyl salicylic acid on platelet aggregation |
Nov/2022 | |
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Risk of Hypertrophic cardiomyopathy after Systemic administration of Hydrocortisone |
Nov/2022 | |
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Tixagevimab + Cilgavimab– Updated dosage recommendations for pre-exposure |
Nov/2022 | |
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Estradiol Valerate + Norethisterone Enanthate - Risk of Breast Cancer Recurrence |
Nov/2022 | |
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Propofol – Reminder of Instructions for Safe Use |
Nov/2022 | |
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Irinotecan – Recommendation for Reduction in Starting Dose to Reduce Risk of |
Oct/2022 |
DHPC Irinotecan risk of Drug toxicity in patients with decreased UGT1A1 activity |
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Onasemnogene abeparvovec - Fatal Cases of Acute Liver Failure Reported |
Oct/2022 | |
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Dexmedetomidine - Increased Risk of Mortality in Intensive Care Unit (ICU) |
Oct/2022 |
DHPC Dexmedetomidine - Increased Risk of Mortality in Intensive Care Unit (ICU) |
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COVID-19 Vaccination Errors in Children |
Sep-2022 | |
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Ketamine- Risk of Biliary Duct Dilatation |
Sep-2022 | |
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Colchicine Serious Poisoning– Reminder of the Rules of Proper Use |
Jul-2022 | |
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Citalopram and Escitalopram – Reminder of Risk of Dose Dependent QT interval Prolongation |
Jul-2022 | |
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Cardiac events, hepatic, blood, kidney side effects and contraindication in specific |
Jun/2022 | |
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Methotrexate - Risk of Progressive Multifocal Leukoencephalopathy (PML) |
Jun/2022 | |
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Hydroxychloroquine Risk of Sweet’s Syndrome and Severe Cutaneous Adverse |
Jun/2022 | |
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The off-label use of trimebutine by injection is of concern with regard to its cardiac toxicity |
May-2022 | |
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Increased risk of Cardiovascular Events & Cardiovascular Mortality when Hydroxychloroquine or Chloroquine used with Macrolide antibiotics |
Apr/2022 | |
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Gabapentin (Neurontin) and precautions regarding concomitant opioid use |
Mar/2022 | |
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Ivermectin 3 mg and 6 mg Scored tablets: Risk of Disturbance of consciousness |
Mar/2022 | |
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PAXLOVID Emergency Use Authorization (EUA) dosing and dispensing in moderate |
Mar/2022 | |
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Anagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation |
Mar/2022 | |
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Mavenclad (Cladribine) – risk of serious liver injury and new recommendations about liver function monitoring |
Mar/2022 | |
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Infliximab: Use of live vaccines in infants exposed in utero or during breastfeeding |
Mar/2022 | |
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Neural tube defects reported in infants born to women exposed to dolutegravir at |
Feb/2022 | |
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Brolucizumab – Updated recommendations to minimize the known risk of |
Feb/2022 | |
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Olsalazine – Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) |
Feb/2022 | |
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Tenofovir Alafenamide: Risk of Renal impairment including renal failure, proximal |
Jan/2022 | |
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Donepezil-QTc interval extension and Torsade de Pointes |
Jan/2022 | |
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Glatiramer Acetate: Rare cases of severe liver damage |
Jan/2022 | |
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Amiodarone Hydrochloride 50 mg/ml concentrate for solution for |
Jan/2022 | DHPC Amiodarone |
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Dapagliflozin 5mg should no longer be used for the treatment of Type 1 Diabetes Mellitus |
Jan/2022 | DHPC Dapagliflozin |
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Dinoprostone: Add A Restriction On Use And Update Of Dosage Recommendations, Warnings And Especially Adding Recommendations On The Risks Of Hyperstimulation Uterine, Uterine Rupture And Fetal / Neonatal Mortality |
Jan/2022 | |
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Voriconazole – Risk of drug-drug interaction with Lurasidone since it may result |
Dec-2021 | |
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Octreotide Solution for Subcutaneous injection and intravenous infusion: Risk of |
Dec-2021 | |
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Important communication regarding Obeticholic acid |
Dec-2021 | |
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Important Safety Information Regarding Use of Molnupiravir in Pregnancy and |
Dec-2021 | |
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Levocetirizine shouldn’t be used in children less than 2 |
Dec-2021 | |
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COVID-19 mRNA Vaccine Spikevax (previously Moderna): risk of myocarditis and pericarditis |
Nov/2021 | |
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COVID-19 mRNA Vaccine Comirnaty: risk of myocarditis and pericarditis |
Nov/2021 |
COVID-19 mRNA Vaccine Comirnaty: risk of myocarditis and pericarditi |
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COVID-19 Vaccine AstraZeneca: Risk of thrombocytopenia (including immune thrombocytopenia) with or without associated bleeding |
Oct/2021 | |
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COVID-19 Vaccine Janssen: Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE) |
Oct/2021 | |
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Baricitinib - This medicinal product is subject to additional monitoring |
Aug/2021 | DHPC Baricitinib |
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COVID-19 Vaccine AstraZeneca: contraindication in individuals with previous capillary leak syndrome |
Jun/2021 | COVID-19 Vaccine AstraZeneca contraindication |
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It was noted that the dosing information (specifically the timing of dosing with respect to food) in the product information for the levodopa-containing products was not optimal: it did not make clear that dosing without food is possible, and maybe preferable for some patients. |
Jun/2021 | Updating Dosing Information Levodopa |
|
COVID-19 Vaccine Janssen: Contraindication in individuals with previous capillary leak syndrome and update on thrombosis with thrombocytopenia syndrome Capillary leak syndrome (CLS) Thrombosis with thrombocytopenia syndrome(TTS) |
Jun/2021 |
J&J Covid 19 Vaccine |
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COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination with |
Jun/2021 | |
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Tofacitinib: initial clinical trial results of increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF-alpha inhibitors. |
Apr/2021 | |
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COVID-19 Vaccine AstraZeneca: Risk of coagulation disorders with or |
Apr/2021 | |
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As the leaflets available in the packs of Leflunomide tablets are currently undergoing important safety updates, we would like to inform you of these important safety updates till their implementation in packs. |
Mar/2021 |
ثالثا: تنبيهات السلامة
| Content | Issue date | Issue |
|
Gabapentin– Risk of SCARs and toxic epidermal necrolysis |
Mar-2024 | Safety Alerts - Gabapentin |
|
Terlipressin– Avoidance in patients with advanced renal dysfunction& Risk of |
Mar-2024 | Safety Alerts - Terlipressin |
|
Voriconazole– Interaction of Voriconazole with Flucloxacillin |
Mar-2024 | Safety Alerts-Voriconazole with Flucloxacillin |
|
Benzyl alcohol containing products —Risk of gasping syndrome in young children |
Mar-2024 | Safety Alerts-Benzyl alcohol |
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Rosuvastatin—Drug-Drug interaction of Rosuvastatin with Ticagrelor |
Jan-2024 | Safety Alerts -Rosuvastatin |
|
Fluconazole—Risk of miscarriage and congenital malformations when using fluconazole during pregnancy also includes the use of lower doses. |
Jan-2024 | Safety Alerts -Fluconazole |
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Alendronate - Risk of low-energy fractures observed in bones other than the femur |
Dec-2023 | Safety Alerts -Alendronate |
|
Alendronate - Risk of low-energy fractures observed in bones other than the femur |
Dec-2023 | Safety Alerts -alendronate |
|
Mesalazine - risk of discolouration of urine after contact with sodium hypochlorite |
Oct-2023 | Safety Alerts -Mesalazine |
|
Statins - risk of Myasthenia Gravis |
Oct-2023 | Safety Alerts -Statins |
|
Fentanyl transdermal Patches - risks of Accidental use and Ingestion |
Oct-2023 | |
|
Ibuprofen/Paracetamol - risks of kounis syndrome &fixed drug eruption |
Oct-2023 | |
|
Methyl Prednisolone- risk of Tumour lysis syndrome & hypothalamic pituitary-adrenal axis suppression |
Aug-2023 | |
|
Tofacitinib sodium succinate –Risk of Hypoglycemia & Retinal venous thrombosis |
Jul-2023 | |
|
Hydrocortisone sodium succinate –Risk of Tumor Lysis Syndrome |
Jul-2023 | |
|
Rivastigmine and risk of QT prolongation and torsade de pointes |
Jul-2023 | |
|
A new warning about Risk of Toxic Epidermal Necrolysis (TEN) for |
April 2023 | |
|
A new warning about Vancomycin and Risk of risk of Kounis syndrome |
Mar 2023 | |
|
Clopidogrel—risk of hemorrhage with aspirin |
Feb 2023 | |
|
Bupropion and the risk of unmasking of Brugada Syndrome |
Feb 2023 | |
|
Betamethasone-Dexamethasone –risk of Pheochromocytoma |
Jan 2023 | |
|
Clopidogrel has been shown to increase rosuvastatin exposure in patients |
Jan 2023 | |
|
Risk of neural tube defects reported in infants born to women exposed to dolutegravir at the time of conception |
Dec 2022 | |
|
A new warning about Suicidal risk of Metronidazole |
Dec 2022 | |
|
Hydroxycobalamin -risk of Interference with platetelet count, aluminuim toxicity, |
Oct 2022 | |
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Leflunomide relationship between leflunomide and skin ulcer |
Sep 2022 | |
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Carbamazepine risk of Interaction with brivaracetam, warnings and recommendations on use during pregnancy and in women of childbearing potential and addition of hyperammonemia to undesirable effects |
Sep 2022 | |
|
Brinzolamide risks of Stevens-Johnson syndrome (SJS) and toxic epidermal |
Aug 2022 | |
|
A new warning about the nephrotoxic potential of clindamycin capsules and |
Aug 2022 | |
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Association of Oxcarbazepine with neurodevelopmental disorders, congenital |
July 2022 | |
|
Ketamine risk of Biliary duct dilatation |
July 2022 | |
|
Linagliptin acid-risk of Hypoglycemia |
Jun-2022 | |
|
Isavuconazole and risk of Anaphylactic reaction |
Jun-2022 | |
|
PPIs risks of hypomagnesemia and severe cutaneous adverse drug reactions |
April 2022 | |
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Ribavirin risk of Embryo-Fetal Toxicity |
April 2022 | |
|
Donepezil-QTc interval extension and Torsade de Pointes |
March 2022 | |
|
A new warning about Thyroid Dysfunction of Iopromide in Pediatric Patients 0 |
March 2022 | |
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A new warning about temozolomide concerning duration of contraception |
March 2022 | |
|
Hydrocortisone in systemic route and risk of hypertrophic cardiomyopathy and |
Feb 2022 | |
|
Icreased risk of Cardiovascular Events & Cardiovascular Mortality when |
Feb 2022 | |
|
Omeprazole Risk of risk of nephrotoxicity |
Feb 2022 | |
|
Upadacitinib and risk of diverticulitis |
Feb 2022 | |
|
Sacubitril/ Valsartan risks of psychiatric disorders as hallucinations , sleep and paranoia |
Feb 2022 | |
|
Pregabalin and risks of Steven Johnson Syndrome and Toxic Epidermal Necrolysis |
Feb 2022 | |
|
Pirfenidone Risks of Stevens-Johnson syndrome (SJS) and toxic epidermal |
Feb 2022 | |
|
Dexamethasone in systemic route and risk of hypertrophic cardiomyopathy and neonatal hypoglycemia |
Feb 2022 | |
|
Ivermectin 3 mg and 6 mg Scored tablets: Risk of Disturbance of consciousness |
Jan-2022 | |
|
Tenofovir Alafenamide: Risk of Renal impairment including renal failure, proximal |
Jan-2022 | |
|
Voriconazole – Risk of drug-drug interaction with Lurasidone since it may result |
Jan-2022 | |
|
Obeticholic acid-risks of hepatic decompensation and liver failure |
Dec-2021 | |
|
Methotrexate - Risk of Progressive Multifocal Leukoencephalopathy (PML) |
Dec-2021 | |
|
Ondansetron and risk of myocardial ischemia |
Dec-2021 | |
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Sulfamethoxazole-Trimethoprim-Hypersensitivity and Other Serious or Fatal Reactions |
Nov-2021 | |
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Venlafaxine and risk of serious discontinuation symptoms |
Nov-2021 | |
|
Ethosuximide and risk of immune thrombocytopenia |
Nov-2021 | |
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NSAID and the risk of oligohydramnios in the second trimester |
Nov-2021 | |
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Duloxetine may cause symptoms of sexual dysfunction |
Nov-2021 | |
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Pentosan – pigmentary maculopathy (changes in the retina of the eye) risk of pigmentary maculopathy (changes in the retina of the eye), especially after long-term |
Oct-2021 | |
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Restriction to use Chloramphenicol in paediatric population less than 2 years since it |
July 2021 | |
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Hydroxychloroquine Risk of Sweet’s Syndrome and Severe Cutaneous Adverse |
Apr-2021 |