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818 results

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Rote-Hand-Brief on Volibris® PDF, 1MB, File is accessible Date: 06. July 2012 Topics: Pharmakovigilanz Type: Download

Active substance: ambrisentan

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.

Carboplatin: Formation of insoluble particles in medicinal products containing carboplatin Date: 04. June 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.

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.

Rote-Hand-Brief on Adenuric® PDF, 113KB, File is accessible Date: 21. May 2012 Topics: Pharmakovigilanz Type: Download

Active substance: febuxostat

Carboplatin: Formation of insoluble particles in medicinal products containing carboplatin Date: 16. May 2012 Topics: Pharmakovigilanz Type: Risk information

Active substance: carboplatin

Extensive measures for risk minimisation have been introduced because of the occurrence of insoluble particles in numerous medicinal products from several pharmaceutical entrepreneurs that contain carboplatin.

Information Letter on Protopic® PDF, 625KB, File is accessible Date: 11. May 2012 Topics: Pharmakovigilanz Type: Download

Active substance: tacrolimus

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.

Information Letter on Viaspan® PDF, 168KB, File is accessible Date: 10. May 2012 Topics: Pharmakovigilanz Type: Download

Organ preservation solution

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 …

Rote-Hand-Brief on Atorvastatin Basics film-coated tablets® PDF, 271KB, File is accessible Date: 03. May 2012 Topics: Pharmakovigilanz Type: Download

Active substance: atorvstatin

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".

Rote-Hand-Brief on Gilenya® PDF, 352KB, File is accessible Date: 30. April 2012 Topics: Pharmakovigilanz Type: Download

Active substance: fingolimod

Rote-Hand-Brief on Carboplatin onkovis® PDF, 85KB, File is accessible Date: 19. April 2012 Topics: Pharmakovigilanz Type: Download

Active substance: carboplatin

Rote-Hand-Brief on Carbomedac® PDF, 45KB, File is accessible Date: 19. April 2012 Topics: Pharmakovigilanz Type: Download

Active substance: carboplatin

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.

Rote-Hand-Brief on Alimta® PDF, 332KB, File is accessible Date: 10. April 2012 Topics: Pharmakovigilanz Type: Download

Active substance: pemetrexed

Rote-Hand-Brief on Protelos® PDF, 2MB, File is accessible Date: 04. April 2012 Topics: Pharmakovigilanz Type: Download

Active substance: strontium ranelate

Information Letter on Viaspan® PDF, 113KB, File is accessible Date: 04. April 2012 Topics: Pharmakovigilanz Type: Download

Organ preservation solution

Information Letter on Pegasys® PDF, 800KB, File is accessible Date: 04. April 2012 Topics: Pharmakovigilanz Type: Download

Active substance: pegylated interferon alfa 2a

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 …

Pioglitazone (Actos®, Competact®, Tandemact®): Guide for prescription and risk management Date: 30. March 2012 Topics: Pharmakovigilanz Type: Risk information

Active substance: pioglitazone

The company Takeda Pharma has published the "Pioglitazone Prescriber's Guide: Patient Selection and Risk Minimisation" thus implementing a further risk minimisation measure from the corresponding decision of the EU Commission.

Rote-Hand-Brief on Samsca® PDF, 585KB, File is accessible Date: 27. March 2012 Topics: Pharmakovigilanz Type: Download

Active substance: tolvaptan

Rote-Hand-Brief on Perfalgan® PDF, 387KB, File is accessible Date: 27. March 2012 Topics: Pharmakovigilanz Type: Download

Active substance: paracetamol i.v.

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.