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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 …

Rote-Hand-Brief on calcitonin-containing medicinal products PDF, 53KB, File is accessible Date: 15. August 2012 Topics: Pharmakovigilanz Type: Download

Active substance: calcitonin

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 Zofran® und Generika PDF, 889KB, File is accessible Date: 14. August 2012 Topics: Pharmakovigilanz Type: Download

Active substance: ondansetron

Information Letter on Torisel® PDF, 2MB, File is accessible Date: 19. July 2012 Topics: Pharmakovigilanz Type: Download

Active substance:: temsirolimus

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.

Carboplatin: Recommendation to filter certain medicinal products containing carboplatin with 0.2 µm filters Date: 11. July 2012 Topics: Pharmakovigilanz Type: Risk information

Active substance: carboplatin

Further measures have been introduced due to the persisting occurrence of insoluble particles in numerous medicinal products containing carboplatin and because of a possible shortage of medicinal products containing carboplatin.

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.

Rote-Hand-Brief on Doribax® PDF, 138KB, File is accessible Date: 10. July 2012 Topics: Pharmakovigilanz Type: Download

Active substance: doripenem