Atossa will remove existing product from the market until concerns are addressed.
May result in local inflammation, phlebitis, and/or low-level allergic response, and could block administration of the drug to the patient, causing a delay in therapy.
Defect due to a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping.
Administration of an injectable with the presence of foreign particulates may result in local inflammation,
thrombophlebitis, and/or low-level allergic response.
L’Agenzia Europea dei Medicinali pubblica un video che illustra il concetto di medicinali sottoposti a monitoraggio addizionale. A partire dall’autunno 2013 un triangolo nero sarà presente nel Foglio Illustrativo e nel Riassunto delle Caratteristiche del Prodotto (RCP) per promuovere la segnalazione di sospette reazioni avverse.
Potential to interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
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