Categories

INVIMA alerta sobre el producto N° 84 de 2017

El Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima) informa a la comunidad que se han detectado irregularidades con el siguiente producto: «Baten® 2MG/ML inyectable (Fluconazol), lotes 615T03 – 615T04 – 615T05». Como medida preventiva Laboratorios Bussié S.A solicita detener el uso de los lotes descritos del producto Baten® 2 mg/mL solución inyectable, con principio activo fluconazol, debido a una presunta contaminación microbiológica de los mismos. Para ampliar la información se puede consultar la Alerta de producto N° 84 de 2017 en el siguiente link:

https://www.invima.gov.co/medicamentos-y-productos-biologicos-aler-sani/alerta-sanitaria-numero-084-baten-2mg2fml-inyectable-fluconazol-lotes-615t03-615t04-615t05-pdf/download.html

 
Categories

Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication – Boxed Warning About Asthma-Related Death Removed

FDA review of clinical safety trials shows that treating asthma with LABAs in combination with ICS does not result in significantly more serious asthma-related side effects than treatment with ICS alone.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm590001.htm

 
Categories

Pantoprazole Sodium for Injection 40 Mg Per Vial: Recall – Presence of Glass Particles

Administration of a glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm589946.htm