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443 results

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Dear Doctor Letter (Rote-Hand-Brief) on Hexvix®: Visual inspection of vials prior to administration PDF, 668KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hexaminolevulinate hydrochloride

Ipsen Pharma GmbH advises healthcare professionals to visually inspect the Hexvix® vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of …

Dear Doctor Letter (Rote-Hand-Brief) on Virazole® (ribavirin) 6 g dry substance, powder to be reconstituted for aerosol administration: Problems with sterility and particle contamination at the manufacturing site PDF, 104KB, File is accessible Date: 23. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ribavirin

MEDA Pharma recommends only treating patients with Virazole® if its use is considered to be absolutely essential.

Dear Doctor Letter (Rote-Hand-Brief) on Strattera® (atomoxetine): Risk of increased blood pressure and/or heart rate PDF, 286KB, File is accessible Date: 13. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: atomoxetine

Important safety-relevant information on the risk of increased blood pressure and/or heart rate associated with the use of Strattera® (atomoxetine) for treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

Dear Doctor Letter (Rote-Hand-Brief) on Torisel® (temsirolimus, concentrate and diluent for solution for infusion): Contamination of the diluent PDF, 576KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temsirolimus

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advises healthcare professionals to visually inspect the diluent prior to administration of Torisel® in order to exclude particle contamination. …

Dear Doctor Letter (Rote-Hand-Brief) on Ceplene® (0.5 mg/0.5 ml solution for injection): Contamination of the diluent PDF, 71KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: histamine dihydrochloride

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advises healthcare professionals to visually inspect the vial prior to administration of Ceplene® in order to exclude particle contamination. The …

Dear Doctor Letter (Rote-Hand-Brief) on Cipralex® (escitalopram): Risk of dose-dependent QT interval prolongation and altered recommendations as to the maximum dose in patients older than 65 years PDF, 176KB, File is accessible Date: 05. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: escitalopram

Important information on the risk of dose-dependent prolongations of the QT interval as well as on altered recommendations as to the maximum dose in patients over 65 years of age. These new scientific findings also apply to all generic …

Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Supply failure, safety aspects PDF, 119KB, File is accessible Date: 28. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Supply failure of Caelyx® (pegylated liposomal doxorubicin) resulting in a further decline in patient supply.

Information letter regarding Apidra® cartridges (insulin glulisine) for injection: Supply of Apidra® PDF, 43KB, File is accessible Date: 24. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin glulisine

Updated information on the availability of Apidra® 3 ml cartridges and further steps until full availability has been restored.

Information Letter on Velcade® 1 mg powder for solution for injection (bortezomib) : Discontinuation of supply due to production difficulties PDF, 97KB, File is accessible Date: 21. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bortezomib

The pharmaceutical manufacturer issues information on the discontinuation of supply of Velcade® 1 mg powder for solution for injection due to production difficulties on the part of the contract manufacturer.

Dear Doctor Letter (Rote-Hand-Brief) on Supertendin® 5 ampoules: Batch recall due to a quality defect PDF, 199KB, File is accessible Date: 17. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexamethasone

The pharmaceutical manufacturer issues new information on the pharmacy and physician level recall of certain batches of Supertendin® 5 ampoules based on a quality defect.