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819 results

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ViaSpan® organ preservation solution: Extended information on possible contamination of product during the manufacture PDF, 168KB, File is accessible Date: 10. May 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: organ preservation solution

Since alternative products are licensed in Germany, all potentially contaminated batches of ViaSpan® were recalled in Germany. In cases in which an infection with Bacillus cereus is suspected, the following information on the resistance …

Rote-Hand-Brief on Atorvastatin Basics film-coated tablets® PDF, 271KB, File is accessible Date: 03. May 2012 Topics: Pharmakovigilanz Type: Download

Active substance: atorvstatin

Dear Doctor Letter (Rote-Hand-Brief) on Atorvastatin Basics film-coated tablets ® (atorvastatin): Recall of all batches of the medicinal product currently in circulation PDF, 271KB, File is accessible Date: 03. May 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: atorvastatin

The maximum daily dose for children (point 3 of the Package Leaflet) is incorrectly stated as "maximum dose of 80 mg once daily" instead of "maximum dose of 20 mg once daily".

Rote-Hand-Brief on Gilenya® PDF, 352KB, File is accessible Date: 30. April 2012 Topics: Pharmakovigilanz Type: Download

Active substance: fingolimod

Rote-Hand-Brief on Carboplatin onkovis® PDF, 85KB, File is accessible Date: 19. April 2012 Topics: Pharmakovigilanz Type: Download

Active substance: carboplatin

Rote-Hand-Brief on Carbomedac® PDF, 45KB, File is accessible Date: 19. April 2012 Topics: Pharmakovigilanz Type: Download

Active substance: carboplatin

Dear Doctor Letter (Rote-Hand-Brief) on Carbopaltin onkovis® 10 mg/ml concentrate for solution for infusion (carboplatin): Possible crystallisation of the active substance PDF, 85KB, File is accessible Date: 19. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carboplatin

Due to the danger of a substance-specific crystallisation of the active substance, the solution must be examined for the absence of particles and turbidity prior to use.

Dear Doctor Letter (Rote-Hand-Brief) on Carbomedac® 10 mg/ml concentrate for solution for infusion (carboplatin): Possible crystallisation of the active substance PDF, 45KB, File is accessible Date: 19. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carboplatin

Due to the danger of a substance-specific crystallisation of the active substance, the solution must be examined for the absence of particles and turbidity prior to use.

Dear Doctor Letter (Rote-Hand-Brief) on Alimta® (pemetrexed): Batch recall PDF, 332KB, File is accessible Date: 10. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pemetrexed

Alimta® 500 mg batches recalled due to a possible microbial contamination with Methylobacterium sp. which was discovered during routine controls. In Germany, this concerns batch A931727G and certain imported batches.

Rote-Hand-Brief on Alimta® PDF, 332KB, File is accessible Date: 10. April 2012 Topics: Pharmakovigilanz Type: Download

Active substance: pemetrexed