65 results match your criteria: "Centre national de pharmacovigilance[Affiliation]"

Aim: Pfizer/BioNTech (BNT162b2) is a COVID-19 vaccine with a reassuring safety profile. The main adverse reactions are mild local reactions. Cutaneous reactions are generally minor.

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Introduction: The Coronavirus Disease 2019 (COVID-19) pandemic led to the fast development of vaccines, which is considered a medical advance in healthcare. With the extensive vaccination campaign performed worldwide, many adverse events following immunization (AEFI) were reported. Most of them were flu-like symptoms, mild and self-limiting.

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Atypical neurological toxicity attributed to oxaliplatin.

Therapie

September 2022

Service d'analyse et de recueil des données, centre national de pharmacovigilance, 1006 Tunis, Tunisia; Unité de recherche: UR17ES12, faculté de médecine, université Tunis-El-Manar, 1006 Tunis, Tunisia.

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An atypical Ramsey Hunt syndrome after covid 19 immunization.

Therapie

July 2022

Centre national de pharmacovigilance, 1006 Tunis, Tunisia; Université Tunis El Manar, faculté de médecine, unité de recherche: UR17ES12, La Rabta, 1007 Tunis, Tunisia.

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Seizures after vaccines.

Therapie

December 2022

Service d'analyse et de recueil des données, centre national de pharmacovigilance, 9, avenue du Dr Zouhaier Essafi, 1006 Tunis, Tunisia; Faculté de médecine de Tunis, 1006 Tunis, Tunisia; Université Tunis El Manar, Faculté de médecine, Unité de recherche, UR17ES12, 1006 Tunis, Tunisia.

Immunization plays an important role in achieving global health goals. Thus, vaccination is one of the essential means of preventing infectious and viral diseases. The onset of adverse events following immunization (AEFI) is common and most of the time it is a mild effect.

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Comparing real-life carbamazepine exposure between innovator and generic formulation.

Therapie

October 2022

Service de pharmacologie clinique, centre national de pharmacovigilance, 1006 Tunis, Tunisia; Laboratoire de recherche de pharmacologie clinique et expérimentale LR16SP02, 1006 Tunis, Tunisia; Faculté de médecine de Tunis, université de Tunis El Manar, 1006 Tunis, Tunisia.

Background: Carbamazepine is an anticonvulsant largely used in the treatment of epilepsy. The use of generic antiepileptic drugs (AEDs) is controversial because of the eventual possibility to loss seizures control. The aim of our study was to compare the concentration over dose ratio of two products containing carbamazepine, the innovator (Tégrétol®-NOVARTIS) and the generic (Taver®-MEDOCHEMIE).

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[Post-vaccination Gianotti-Crosti syndrome with unusual localization].

Therapie

October 2022

Centre national de pharmacovigilance, 1006 Tunis, Tunisie; Unité de recherche : UR17ES12, La Rabta, faculté de médecine, université Tunis- El-Manar, 1007 Tunis, Tunisie.

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Leukocytoclastic vasculitis mimicking photosensitivity induced by thiamazole.

Therapie

October 2022

Centre national de pharmacovigilance, 1006 Tunis, Tunisia; Unité de recherche: UR17ES12, La Rabta, faculté de médecine, université Tunis-El-Manar, 1007 Tunis, Tunisia.

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Objective: To characterise the factors associated with HIV treatment failure (HIVTF) from reported pharmacovigilance data in Africa.

Materials And Methods: This is an observational pharmacovigilance analysis of the safety data of HIVTF available in the WHO International Pharmacovigilance database 'VigiBase '. We used the Standardised MedDRA Queries (SMQ) to identify all the terms corresponding to HIVTF.

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Drug-drug interactions between two beta-lactam antibiotics and valproic acid in the same patient.

Therapie

March 2022

Service de pharmacologie clinique-centre national de pharmacovigilance, 9, Avenue Dr Zouhaier Essafi, 1006 Tunis, Tunisia; Laboratoire de recherche en pharmacologie clinique et expérimentale (LR16SP02), 1006 Tunis, Tunisia; Faculté de médecine de Tunis, université de Tunis El Manar, 1006 Tunis, Tunisia.

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[Comparison of two kits of anti-infliximab antibodies plasmatic measurement].

Ann Biol Clin (Paris)

August 2019

Université de Tunis El Manar-Faculté de médecine de Tunis, Centre national de pharmacovigilance, Service de pharmacologie clinique, Laboratoire de pharmacologie clinique et expérimentale (LR 16SP02), Tunis, Tunisie.

Unlabelled: Infliximab (IFX) is a chimeric monoclonal antibody which has proven its efficacy in the treatment of inflammatory diseases. However, its efficacy can be limited by the development of anti-IFX antibodies (ATI) resulting in a therapeutic failure of IFX. ATI plasmatic monitoring is then indicated to optimize IFX treatment.

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Recurrence of DRESS syndrome to escitalopram or neosensitization?

Therapie

September 2019

Centre national de pharmacovigilance Chalbi Belkahia, 1006 Tunis, Tunisia; Université Tunis El Manar, faculté de médecine, unité de recherche UR17ES12, La Rabta, 1007 Tunis, Tunisia.

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Background: In early 2016, there was a Yellow Fever (YF) outbreak in Central Africa with several deaths reported from Angola and the Democratic Republic of Congo. Due to a shortage in vaccine supply, fractional dosing (0.1 ml) of 17DD Yellow Fever Vaccine (YFV) was proposed in preventive vaccination campaign in Kinshasa in August 2016.

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[Antiepileptic drugs administration by nasogastric tube in comatose patients].

Therapie

September 2018

Service de pharmacologie clinique, centre national de pharmacovigilance, faculté de médecine de Tunis, université de Tunis El Manar, 9, avenue Dr Zouheïr Essafi, 1006 Tunis, Tunisie; Laboratoire de recherche pharmacologie clinique et expérimentale LR16SP02, 1006 Tunis, Tunisie.

Aim: To evaluate the modalities of administration of antiepileptic drugs (AED) with nasogastric tube (NGT) by nurses and to draw up recommendations.

Methods: Our study consisted on investigating the modalities of administration of AED's with NGT by nurses during four months. We prepared 10 questions including demographic information.

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Limited sampling strategy for the estimation of mycophenolic acid area under the curve in Tunisian renal transplant patients.

Nephrol Ther

November 2017

Service de pharmacologie clinique, centre national de pharmacovigilance, 9, avenue du Dr Zouheir Essafi, 1006 Tunis, Tunisia; Laboratoire de recherche de pharmacologie clinique et expérimentale LR16SP02, Tunis, Tunisia; Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia.

Mycophenolate mofetil is a prodrug widely used in renal transplantation to prevent organ rejection. It is hydrolyzed to its active compound mycophenolic acid (MPA). MPA area under the curve (AUC) is considered the best pharmacokinetic parameter for the estimation of MPA exposition and for prediction of rejection.

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Introduction: The mainstay of onchocerciasis control currently is mass administration of ivermectin; however, this may be associated with serious adverse events, including deaths, when administered in areas where onchocerciasis and loiasis are co-endemic.

Objectives: The objective of the current study was to describe the central and peripheral nervous system disorders that occurred after mass administration of ivermectin in Democratic Republic of Congo (DRC).

Methods: This is a retrospective descriptive study involving a review of data on adverse events related to mass administration of ivermectin.

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Article Synopsis
  • - Anaphylactic reactions can be triggered by medications, with penicillin derivatives being the most common culprits, and they can lead to a condition called Kounis syndrome, which involves acute coronary syndrome coupled with hypersensitivity reactions.
  • - A case study is presented of a 58-year-old woman who suffered anaphylactic shock after taking amoxicillin-clavulanic acid for pharyngitis, leading to fatal coronary stent thrombosis and acute myocardial infarction despite emergency treatment.
  • - The study emphasizes the need to consider Kounis syndrome in cases of acute coronary syndrome, as amoxicillin-clavulanic acid was identified as a likely cause of the patient's anaphylactic reaction, complicating her cardiac condition.
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[Comparative study of two techniques of ciclosporine monitoring].

Ann Biol Clin (Paris)

September 2016

Service de pharmacologie clinique, Centre national de pharmacovigilance, Tunis, Tunisie, Faculté de médecine, Université de Tunis El Manar, Tunis, Tunisie.

Ciclosporine (CsA) is an immunosuppressant drug used in bone marrow transplantation in order to extend allograft survival. Despite its efficiency, CsA can expose to therapeutic failure or to toxicity because of underdosing or overdosage. So, many techniques of monitoring CsA in blood were used, the referance one is the chromatographic technique then, the automated techniques: fluorescence polarization immunoassay (FPIA) and chimiluminescent microparticle immunoassay (CMIA).

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[Delayed convulsion after lidocaine instillation for bronchoscopy].

Rev Mal Respir

May 2016

Faculté de médecine de Tunis, université de Tunis El Manar, 1007 Tunis, Tunisie; Service de pharmacologie clinique, centre national de pharmacovigilance de Tunis, 9, avenue Dr. Zouheir Essafi, 1006 Tunis, Tunisie.

Introduction: Lidocaine toxicity usually appears rapidly and is directly correlated with plasma concentrations of the drug.

Case Report: We report a case of a late neurologic toxicity occurring after instillation of lidocaine during fibre-optic bronchoscopy. A patient with bronchiolitis obliterans underwent a diagnostic bronchoscopy.

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Introduction: Valproic acid (VA) is a widely used antiepileptic drug. Because of its pharmacokinetic variability and the influence of intrinsic and extrinsic factors such as the treatment compliance, VA therapeutic drug monitoring (TDM) is recommended in children. The aim of this study is to evaluate the effect of treatment compliance and the economic level on VA tough plasmatic concentration (TPC) and epileptic rhythm in children.

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[DRESS syndrome induced by ciprofloxacine].

Nephrol Ther

April 2015

Centre national de pharmacovigilance de Tunis, 9, avenue du Dr Zouheir Essafi, 1006 Bab Souika Tunis, Tunisie; Faculté de médecine de Tunis, université Tunis El Manar, 15, rue Djebel Lakhdhar, La Rabta, 1007 Tunis, Tunisie.

The Drug rash with hypereosinophilia and systemic symptoms (DRESS) syndrome, or hypersensitivity syndrome, is a severe drug-induced hypersensitivity syndrome. It has been exceptionally described with ciprofloxacin. We report a 47-year-old-woman who developed DRESS syndrome, 2 days after taking ciprofloxacin for a urinary infection.

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Vancomycin therapeutic drug monitoring in cerebrospinal fluid.

Therapie

February 2015

Service de pharmacologie clinique, Centre national de pharmacovigilance, Tunis, Tunisie - Université de Tunis El Manar, Faculté de médecine, Tunis, Tunisie.

Vancomycin penetrates poorly through the blood-brain barrier. Determination of vancomycin concentration in plasma is recommended. In contrast, its determination in cerebrospinal fluid (CSF) is rarely performed.

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