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Dear Doctor Letter (Rote-Hand-Brief) on Angiox® (bivalirudin): Inappropriate "bolus-only" dosing for PCI PDF, 235KB, File is accessible Date: 08. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bivalirudin

Communication for healthcare professionals based on reports of IV bolus injections of Angiox® (bivalirudin) alone without immediately following IV infusions. The resulting sub-therapeutic plasma concentrations bear the risk of ineffective …

Dear Doctor Letter (Rote-Hand-Brief) on Tredaptive®: Results of a clinical study PDF, 781KB, File is accessible Date: 02. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: niacin, laropiprant

Recommendation not to start new patients on treatment with Tredaptive® as the primary endpoint could not be met in the cardiovascular endpoint study HPS2-THRIVE.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Risk of liver diseases PDF, 268KB, File is accessible Date: 10. December 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Information for health care professionals regarding the risk of liver diseases in connection with the use of Revlimid® (lenalidomide) in the presence of other risk factors.

Information Letter on Tyverb® (lapatinib): Combination treatment with Tyverb® (lapatinib) less effective in certain settings PDF, 1,010KB, File is accessible Date: 10. December 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lapatinib

Important information on Tyverb® (lapatinib): Comparative data from clinical trials have shown that in certain settings combination treatments containing lapatinib are less effective than those containing trastzumab (Herceptin®).

Dear Doctor Letter (Rote-Hand-Brief) on Ultravist® (iopromide): Batch recall PDF, 351KB, File is accessible Date: 15. November 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: iopromide

It cannot be ruled out with certainty that the delivered batch 22763A of the medicinal product Ultravist® 300 10x10 ml (PZN 3049076) has been intermixed with Primovist® 10 ml (labelled as Ultravist 30). Therefore, all stocks of this batch are …

Dear Doctor Letter (Rote-Hand-Brief) on Partusisten® intrapartal (fenoterol hydrobromide): Shortage, possible alternative: Partusisten® concentrate for solution for infusion PDF, 107KB, File is accessible Date: 30. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fenoterol hydrobromide

Due to a shortage in the supply of Partusisten® intrapartal the company has published information that the medicinal product Partusisten® concentrate for solution for infusion can be used as an alternative. Partusisten® concentrate for …

Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Shortage, introduction of a web-based ordering and reservation system PDF, 152KB, File is accessible Date: 30. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Supply problems with regard to Caelyx® have been reported in the past. A further letter with information on the reintroduction of Caelyx® is being circulated now. Due to the persisting shortage the company has introduced a web-based ordering …

Agomelatine (Valdoxan®/Thymanax®): Risk of hepatotoxicity PDF, 190KB, File is accessible Date: 25. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: agomelatine

Liver function tests are to be performed regularly in patients treated with agomelatine. The medicinal product should be discontinued immediately if an increase in transaminases exceeds 3 times the upper limit of normal or if typical symptoms …

Pegasys® pre-filled syringes (pegylated interferon alfa-2a): Risk of possible shortages PDF, 2MB, File is accessible Date: 04. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated interferon alfa-2a

A further information letter states that the risk of possible shortages of Pegasys® pre-filled syringes will persist over longer period of time than originally expected. The company Roche now estimates that the supply situation of the …

Macugen® (pegaptanib sodium): Risk of a serious increase in intraocular pressure due to intravitreal injection of excess volume of Macugen® PDF, 157KB, File is accessible Date: 01. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegaptanib sodium

In order to ensure a safe intravitreal administration of Macugen®, the excess volume must be expelled from the pre-filled syringe before use.