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Dear Doctor Letter (Rote-Hand-Brief) on DepoCyte® 50 mg suspension for injection (liposomal cytarabine for intrathecal injection): Recall of the medicinal product PDF, 224KB, File is accessible Date: 29. August 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: liposomal cytarabine

During an inspection, critical deficiencies were found at the manufacturing site of the finished product DepoCyte®. Due to the potential risk of lacking sterility the medicinal product is recalled. Patients are to be switched to alternative …

Dear Doctor Letter (Rote-Hand-Brief) on calcitonin: Restriction of indication PDF, 53KB, File is accessible Date: 15. August 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: calcitonin

Important information on the connection between calcitonin and malignancies – new restrictions for use and recall of nasal spray.

Information letter on ZOFRAN® (ondansetron) and generic medicinal products PDF, 889KB, File is accessible Date: 14. August 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ondansetron

The pharmaceutical manufacturer issues information on important new findings regarding ondansetron (ZOFRAN® and generics) and the dose-dependent QTc interval prolongation – new reduction of intravenous dose.

Information Letter on Torisel® (temsirolimus): Fragments of glass possibly present in the diluent PDF, 2MB, File is accessible Date: 19. July 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temsirolimus

Important information on the possible presence of fragments of glass in batches AGBV/99 and AGQQ/13 of vials of the diluent Torisel® and recommended measures.

Dear Doctor Letter (Rote-Hand-Brief) on Doribax® (doripenem): New therapeutic recommendations PDF, 138KB, File is accessible Date: 11. July 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: doripenem

New recommendations regarding dosage and duration of treatment as well as precautionary measures when administering Doribax® (doripenem) to patients with nosocomial pneumonia.

Dear Doctor Letter (Rote-Hand-Brief) on VOLIBRIS® (ambrisentan): New Contraindication PDF, 1MB, File is accessible Date: 09. July 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ambrisentan

VOLIBRIS® (ambrisentan) must not be given to patients with idiopathic pulmonary fibrosis (IPF).

Anapen® solution for injection 300 μg adrenaline in 0.3 ml solution for injection, pre-filled syringe / Anapen® Junior 150 μg adrenaline in 0.3 ml solution for injection, pre-filled syringe by Lincoln Medical Limited (adrenaline): Recall of all batches on patient level PDF, 103KB, File is accessible Date: 06. June 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: adrenaline

Lincoln Medical Limited is recalling all unexpired units of the a.m. medicinal product because of the risk of failure to deliver the adrenaline solution in an anaphylactic emergency situation.

Adenuric® (febuxostat): Risk of hypersensitivity reactions including Stevens-Johnson Syndrome and acute anaphylactic reaction/shock PDF, 113KB, File is accessible Date: 22. May 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: febuxostat

Serious hypersensitivity reactions have been reported under treatment with Adenuric®. In most of the cases these reactions occurred during the first month of treatment with febuxostat.

Information Letter on Protopic® (tacrolimus): Recommendations for the correct use PDF, 625KB, File is accessible Date: 11. May 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tacrolimus

Important recommendations for the correct use of Protopic® (0.03% and 0.1%) Ointment in order to minimise risks, especially when treating children.

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 …