WHO Pharmaceuticals Newsletter 2004, No. 06
(2004; 13 pages) Ver el documento en el formato PDF
Índice de contenido
Cerrar esta carpetaREGULATORY MATTERS
Ver el documentoACTRA-RX AND YILISHEN - Presence of undeclared sildenafil
Ver el documentoADALIMUMAB - Serious infections if used together with anakinra
Ver el documentoANTIDEPRESSANTS Label to warn of increased suicidality in children; Patient Medication Guide to advise on risks and precautions to be taken
Ver el documentoATORVASTATIN - Interaction with grapefruit juice
Ver el documentoBLACK COHOSH COMBINATION #2; YELLOW DOCK COMBINATION #3 - Presence of aristolochic acid
Ver el documentoCELECOXIB - Withdrawn in Turkey
Ver el documentoEPOETIN ALFA - Label change to reflect thrombosis risk
Ver el documentoETANERCEPT, INFLIXIMAB - Reports of serious infections
Ver el documentoINFLIXIMAB - Lymphoma warning added to US Remicade label
Ver el documentoISOTRETINOIN - Enhancement to risk management programme
Ver el documentoLEVOTHYROXINE SODIUM - Dysphagia and risk of choking
Ver el documentoMIFEPRISTONE - Important labelling changes proposed
Ver el documentoPERGOLIDE MESYLATE - Label change: risk of cardiac valvulopathy
Ver el documentoREMINYL AND AMARYL - Reports of medication errors
Ver el documentoVALDECOXIB - Label updated to warn about skin reactions
Abrir esta carpeta y ver su contenidoSAFETY OF MEDICINES
Ver el documentoFEATURE
 

EPOETIN ALFA - Label change to reflect thrombosis risk

Canada. The Canadian product monograph for epoetin alfa (Eprex) has been revised to include information regarding a possible increased incidence of thrombosis in patients with cancer who have high haemoglobin levels (>120 g/L). The 'Dear Health-are Professional' letter issued by Janssen-Ortho Inc, in consultation with Health Canada, advises that the Contraindications, Warnings, Precautions, Adverse Reactions, Dosage and Administration and Information for the Patient sections have been updated to reflect this safety information.

Reference:

'Dear Health-care Professional' letter from Janssen-Ortho Inc, 13 October 2004. Available on the Internet at www.hc-sc.gc.ca

Reports in WHO-file: Thrombosis 105

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Última actualización: le 3 mayo 2013