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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).

Dear Doctor Letter on Perfalgan®: Inadvertent overdose in newborn babies and infants PDF, 1MB, File is accessible Date: 14. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: paracetamol i.v.

Important information on the risk of inadvertently overdosed intravenous infusion of paracetamol 10 mg/ ml to newborn babies and infants.

Dear Doctor Letters on temozolomide: Recall Date: 09. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temozolomide

For precautionary reasons the pharmaceutical companies will recall certain batches of temozolomide.

Information Letter on Exelon® and Prometax® transdermal patches: incorrect administration and medication error PDF, 51KB, File is accessible Date: 29. April 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rivastigmine

In association with the rivastigmine transdermal patches, Exelon® and Prometax®, cases of overdosage due to medication errors and incorrect administration have been reported.

Dear Doctor Letter (Rote-Hand-Brief) on Kepivance®: Restriction of indication PDF, 2MB, File is accessible Date: 20. April 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: palifermin

Indication for Kepivance® restricted to patients exposed to radiotherapy and chemotherapy for conditioning prior to autologous stem cell transplantation.

Dear Doctor Letter (Rote-Hand-Brief) on REGRANEX®: Extension of existing contraindications PDF, 79KB, File is accessible Date: 15. March 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: becaplermin

REGRANEX® (active substance: becaplermin) contraindicated for patients with malign diseases.