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Information Letter on Carmubris® powder and solution for infusion (carmustine, 100 mg): Overfilled vial found PDF, 239KB, File is accessible Date: 14. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carmustine

In the course of routine stability testing, an overfilled vial was found in a specific batch of Carmubris®. Such overfilled vials pose a significant risk of overdosing patients.

Information Letter on Neupro®/Leganto® (rotigotine transdermal patch): New room-temperature stable formulation PDF, 203KB, File is accessible Date: 10. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rotigotine

Licensing of improved formulation for Neupro®/Leganto® allowing storage at room temperature.

Dear Doctor Letter (Rote-Hand-Brief) on Zostex® (brivudine): Potentially fatal interaction with 5-fluoropyrimidines PDF, 577KB, File is accessible Date: 03. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: brivudine

Important information to be observed: concomitant use of brivudine and 5-fluoropyrimidines (also in topical preparations and in combination medicinal products) is contraindicated due to the risk of potentially fatal interactions.

Dear Doctor Letter (Rote-Hand-Brief) on Tavanic® (levofloxacin) and generic medicinal products: Restriction of indications, new serious adverse reactions and precautions for use PDF, 601KB, File is accessible Date: 03. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levofloxacin

In agreement with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), restrictions of indications and the inclusion of new serious adverse reactions as well as corresponding warnings in the product …

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).