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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 …

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 …

Dear Doctor Letter (Rote-Hand-Brief) on Atorvastatin Basics film-coated tablets ® (atorvastatin): Recall of all batches of the medicinal product currently in circulation PDF, 271KB, File is accessible Date: 03. May 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: atorvastatin

The maximum daily dose for children (point 3 of the Package Leaflet) is incorrectly stated as "maximum dose of 80 mg once daily" instead of "maximum dose of 20 mg once daily".

Dear Doctor Letter (Rote-Hand-Brief) on Carbopaltin onkovis® 10 mg/ml concentrate for solution for infusion (carboplatin): Possible crystallisation of the active substance PDF, 85KB, File is accessible Date: 19. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carboplatin

Due to the danger of a substance-specific crystallisation of the active substance, the solution must be examined for the absence of particles and turbidity prior to use.

Dear Doctor Letter (Rote-Hand-Brief) on Carbomedac® 10 mg/ml concentrate for solution for infusion (carboplatin): Possible crystallisation of the active substance PDF, 45KB, File is accessible Date: 19. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carboplatin

Due to the danger of a substance-specific crystallisation of the active substance, the solution must be examined for the absence of particles and turbidity prior to use.

Dear Doctor Letter (Rote-Hand-Brief) on Alimta® (pemetrexed): Batch recall PDF, 332KB, File is accessible Date: 10. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pemetrexed

Alimta® 500 mg batches recalled due to a possible microbial contamination with Methylobacterium sp. which was discovered during routine controls. In Germany, this concerns batch A931727G and certain imported batches.

Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): New contraindications PDF, 2MB, File is accessible Date: 04. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: strontium ranelate

The pharmaceutical entrepreneur is sending out information on new contraindications and warnings for the use of Protelos® (strontium ranelate). These changes also apply to Osseor®.

Information Letter on Pegasys® (pegylated interferon alfa 2a) pre-filled syringes: Possible shortage PDF, 800KB, File is accessible Date: 04. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated interferon alfa 2a

Possible shortage of the pharmaceutical form Pegasys® pre-filled syringes and recommendations for healthcare professionals. Prefilled pens are not affected.

Information Letter on Viaspan® (organ preservation solution): Possible contamination of product during the manufacture PDF, 113KB, File is accessible Date: 04. April 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® are recalled in Germany as a precautionary measure. Close medical monitoring after transplantation is recommended for affected patients by way …

Dear Doctor Letter (Rote-Hand-Brief) on Perfalgan® 10 mg/ml solution for infusion (paracetamol i.v.): Risk of accidental overdosage PDF, 387KB, File is accessible Date: 27. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: paracetamol i.v.

The pharmaceutical manufacturer again refers to the risk of an accidental overdosage of Perfalgan® 10 mg/ml solution for infusion in neonates and infants as well as in underweight adults.

Dear Doctor Letter (Rote-Hand-Brief) on Samsca® (tolvaptan): Risk of too rapid rise of serum sodium PDF, 585KB, File is accessible Date: 27. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolvaptan

The pharmaceutical manufacturer issues information on the risk of a too rapid rise of serum sodium levels due to the use of Samsca® (tolvaptan) and on how this risk can be reduced.

Information Letter on Vfend® 200 mg powder for solution for infusion (voriconazole): Temporary shortage PDF, 47KB, File is accessible Date: 12. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: voriconazole

It is recommended to limit the use of the product to patients without alternative treatment options. An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned.

Information Letter on Onglyza® (saxagliptin): Risk of serious hypersensitivity reactions and acute pancreatitis PDF, 183KB, File is accessible Date: 08. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saxagliptin

The pharmaceutical manufacturer issues information on important new findings on the use of Onglyza® (saxagliptin) and the related risk of serious hypersensitivity reactions and acute pancreatitis.