Alerta De Seguridad para Piperacilin - Tazobactam

Según Health Ministry (Panama), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Panama que fue producido por Pharmayect SA, Laboratorio Libra SA, Laboratorio Richet SA, Aurobindo Pharma Ltd.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2017-08-24
  • Fecha de publicación del evento
    2017-09-01
  • País del evento
  • Fuente del evento
    HMP
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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

  • Modelo / Serial
  • Descripción del producto
    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