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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.

Information Letter on Halaven® (eribulin): Danger of dosing errors PDF, 58KB, File is accessible Date: 05. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: eribulin

Danger of dosing errors due to the fact that the dose is stated differently in the EU compared to several other regions and in some publications.

Dear Doctor Letter (Rote-Hand-Brief) on Rasilez®, Rasilez HCT® and Rasilamlo® (aliskiren): New contraindications and warnings in connection with the use of aliskiren-containing medicines PDF, 87KB, File is accessible Date: 27. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aliskiren

Important information on new contraindications and warnings in connection with the use of aliskiren-containing medicinal products in combination with inhibitors of the angiotensin converting enzyme (ACE inhibitors) or angiotensin receptor …

Dear Doctor Letter (Rote-Hand-Brief) on Victrelis (boceprevir): Drug interactions with ritonavir-boosted HIV protease inhibitors PDF, 100KB, File is accessible Date: 24. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: boceprevir

In co-ordination with the European Medicines Agency (EMA) the pharmaceutical entrepreneur is circulating information on new findings on drug interactions between boceprevir, a recently licensed oral inhibitor of the hepatitis C virus …

Information Letter on Mircera® (methoxy polyethylene glycol-epoetin beta): Impending supply failure, note on switching to alternative treatments PDF, 1MB, File is accessible Date: 02. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methoxy polyethylene glycol-epoetin beta

An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned.

Information Letter on Mircera® (methoxy polyethylene glycol-epoetin beta): Possible shortages: Note on switching to alternative treatments PDF, 886KB, File is accessible Date: 02. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methoxy polyethylene glycol-epoetin beta

An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Increased cardiovascular monitoring at the beginning of treatment PDF, 638KB, File is accessible Date: 27. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Important additional recommendations regarding a more intense monitoring of cardiovascular functions at the beginning of treatment with Gilenya® (fingolimod) in patients with relapsing-remitting multiple sclerosis.

Dear Doctor Letter (Rote-Hand-Brief) on Velcade® (bortezomib): Intravenous injection is the only correct route of administration PDF, 127KB, File is accessible Date: 16. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bortezomib

The only licensed route of administration of Velcade® (1 mg, 3.5 mg, powder for solution for injection) is via intravenous injection. Velcade® must not be administered in any other manner.

Dear Doctor Letter (Rote-Hand-Brief) on Rasilez®, Rasilez HCT® and Rasilamlo® (aliskiren): Potential risks of cardiovascular or renal adverse events PDF, 72KB, File is accessible Date: 05. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aliskiren

Important information on potential risks of cardiovascular or renal adverse events in patients with type 2 diabetes and renal impairment and/or cardiovascular diseases who are being treated with medicinal products containing aliskiren.

Dear Doctor Letter (Rote-Hand-Brief) on UVADEX™: Visual inspection of vials prior to administration PDF, 57KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance:

Therakos Europe advises healthcare professionals to visually inspect the UVADEX™ vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of the …

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.

Dear Doctor Letter (Rote-Hand-Brief) on Cipramil® (citalopram): Risk of dose-dependent QT interval prolongation PDF, 147KB, File is accessible Date: 31. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: citalopram

Important information on the risk of dose-dependent prolongations of the QT interval as well as on altered recommendations as to the maximum dose.

These new scientific findings also apply to all generic marketing authorisations of …

Dear Doctor Letter (Rote-Hand-Brief) on Pradaxa® (dabigatran etexilate): Necessity of monitoring renal function PDF, 428KB, File is accessible Date: 27. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dabigatran etexilate

Summaries of Product Characteristics and reference material for physicians extended to include information on the necessity of determining the creatinine clearance prior to beginning treatment as well as of further control of renal function.

…

Dear Doctor Letter (Rote-Hand-Brief) on Supertendin® 5 ampoules: Batch recall due to a quality defect PDF, 237KB, File is accessible Date: 27. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexamethasone

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

Dear Doctor Letter (Rote-Hand-Brief) on Advagraf® 0.5 mg hard capsules (tacrolimus): Risk of increased blood levels of tacrolimus due to use of particular batches PDF, 299KB, File is accessible Date: 21. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tacrolimus

The pharmaceutical manufacturer issues information on the fact that there is a risk of higher levels of tacrolimus in the blood of patients taking Advagraf® 0.5 mg hard capsules due to quality defects detected in particular batches. The …

Dear Doctor Letter (Rote-Hand-Brief) on Refludan® (lepirudin): Permanent discontinuation of the distribution of Refludan® PDF, 347KB, File is accessible Date: 21. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lepirudin

The pharmaceutical manufacturer issues information on the planned permanent discontinuation of the distribution of Refludan® as of 1 April 2012 as well as on switching patients currently taking Refludan® to treatment alternatives in due time.

…

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Risk of second primary malignancies PDF, 479KB, File is accessible Date: 20. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Important information on the risk of second primary malignancies in patients treated with Revlimid® (lenalidomide). Results of the benefit-risk review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines …