Events

Alerte De Sécurité sur Piperacilin - Tazobactam

Selon Health Ministry (Panama), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Panama qui a été fabriqué par Pharmayect SA, Laboratorio Libra SA, Laboratorio Richet SA, Aurobindo Pharma Ltd.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-08-24
  • Date de publication de l'événement
    2017-09-01
  • Pays de l'événement
    Panama
  • Source de l'événement
    HMP
  • URL de la source de l'événement
    http://www.minsa.gob.pa/informacion-salud/alertas-y-comunicados?title=&field_decree_date_value%5Bvalue%5D%5Byear%5D=2017&page=4
  • Notes / Alertes
    Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Panama.
  • Notes supplémentaires dans les données
  • Cause
    The drug regulatory authority of canada, health canada, conducted a safety review to assess the possible link between the combination of antimicrobial drugs piperacillin and tazobactam or piperacillin alone and the drug reaction with eosinophilia and systemic symptom or dress syndrome by its acronym in english (drug reaction with eosinophilia and systemic symptom) after published cases of dress associated with the combination of these drugs. dress syndrome describes a group of rare but serious and life-threatening adverse reactions to medications, such as fever, severe skin rash with swollen or bare skin on large areas of the body, etc. these reactions usually occur two weeks to two months after starting a medication. .

Device

Piperacilin - Tazobactam
  • Modèle / numéro de série
  • Description du dispositif
    Piperacillin is an extended spectrum beta-lactam antibiotic that belongs to the ureidopenicillin class. The pair is usually co-administered with the beta-lactamase tazobactam inhibitor, leading to increased activity including Gram positive and Gram negative pathogens, and aerobic organisms such as Pseudomonas aeruginosa. Piperacillin is used for the treatment of infections susceptible to strains of microorganisms such as staphylococcus, streptococcus and klebsiella genus. It is indicated for pulmonary, intra-abdominal infections, complicated urinary tract infections and others.
  • Manufacturer
    Pharmayect SA, Laboratorio Libra SA, Laboratorio Richet SA, Aurobindo Pharma Ltd

Manufacturer

Pharmayect SA, Laboratorio Libra SA, Laboratorio Richet SA, Aurobindo Pharma Ltd
  • Source
    HMP