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443 results

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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.

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 …