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443 results

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Information Letter on Axura® and Ebixa®: Overdosage due to administration errors PDF, 55KB, File is accessible Date: 29. October 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: memantine hydrochloride

Information for medical experts regarding overdosage due to administration errors of the medicinal products Axura® und Ebixa® containing memantine hydrochloride.

Rote-Hand-Brief (Dear Doctor Letter) regarding Leflunomid medac® laboratory tests PDF, 474KB, File is accessible Date: 29. October 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leflunomide

Correction of the information on laboratory tests to be performed when administering Leflunomid medac®.

Information Letter on Vfend®: possible occurrence of squamous cell carcinomas of the skin PDF, 370KB, File is accessible Date: 27. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: voriconazole

Important safety-relevant information on the potential risk of the occurence of squamous cell carcinomas of the skin in patients taking Vfend® (voriconazole) as long-term treatment.

Anti-diabetics containing rosiglitazone: Order of discontinuation in Germany due to cardiovascular risks and Dear Doctor Letter (Rote-Hand-Brief) PDF, 238KB, File is accessible Date: 24. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rosiglitazone

In a decision dated 23 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the recall of anti-diabetics containing rosiglitazone from the trade chain in Germany down to the pharmacy level. Due to the necessity …

Information Letter regarding Relistor®: Occurrence of gastrointestinal perforations PDF, 2MB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methylnaltrexone bromide

Important safety information on the occurrence of gastrointestinal perforations in patients who received RELISTOR® (active substance: methylnaltrexone bromide) for subcutaneous injection.
An information letter including the Fachinformation

Main information on contrast media containing gadolinium: Risk of nephrogenic systemic fibrosis (NSF) PDF, 44KB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

Summarising information on the risk of nephrogenic systemic fibrosis in association with the administratiion of gadolinium-containing contrast media.

Dear Doctor Letter on Xyrem®: Risk of dosing errors PDF, 1MB, File is accessible Date: 12. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium oxybate

Risk of dosing errors with Xyrem® (sodium oxybate) because gramme (g) and milliliter (ml) are easily confused.

Dear Doctor Letter (Rote-Hand-Brief) regarding Ketoprofen, topical formulations PDF, 58KB, File is accessible Date: 09. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoprofen

Important safety information about the risk of photosensivity reactions in association with topical uses of Ketoprofen.

Dear Doctor letter (Rote Hand Brief) on Cardioxane®: Secondary neoplasia in children PDF, 1MB, File is accessible Date: 26. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexrazoxane

Important safety information on Cardioxane® (dexrazoxane) and increased risk for secondary neoplasia in children.

Dear Doctor letter on Invirase®: QT-prolongations PDF, 2MB, File is accessible Date: 15. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saquinavir

Additional safety information on the arrhythmogenic risk due to QT and PR interval prolongations in association with Invirase (saquinavir).