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Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Hemophagocytic syndrome PDF, 1MB, File is accessible Date: 18. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis Pharma GmbH is circulating information on reports of 2 cases of a hemophagocytic syndrome (HPS) leading to the deaths of patients with relapsing-remitting multiple sclerosis treated with fingolimod.

Dear Doctor Letter (Rote-Hand-Brief) on COSOPT-S® 20 mg/ml and 5 mg/ml eye drops in single-dose containers: Risk of eye injury PDF, 160KB, File is accessible Date: 18. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dorzolamide hydrochloride

The company MSD Sharp & Dohme GmbH is circulating information on changes in the design of the product resulting in instructions for use to be observed in order to avoid eye injury.

Dear Doctor Letter (Rote-Hand-Brief) on solutions for infusion that contain hydroxyethyl starch (HES): New contraindications and restrictions in indications
PDF, 513KB, File is accessible
Date: 15. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyethyl starch

The marketing authorisation holders are circulating information on new contraindications to be observed and further restrictions in indications.

Dear Doctor Letter (Rote-Hand-Brief) on JEXT® Adrenalin Autoinjector: Recall on patient level due to quality deficiency PDF, 2MB, File is accessible Date: 12. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: adrenalin

As a precautionary measure, the company ALK-Abelló Arzneimittel GmbH is recalling five batches of the Adrenalin Autoinjector JEXT® in Germany: four batches of the 300 microgram strength and one batch of the 150 microgram strength. The batches …

Dear Doctor Letter (Rote-Hand-Brief) on Pegasys® pre-filled syringes (pegylated interferon alfa-2a): Counterfeit of batch B1299B03 PDF, 1MB, File is accessible Date: 11. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated interferon alfa-2a

The company Roche Pharma AG is circulating information that a counterfeit of Pegasys® 180 microgram/0.5 ml (pegylated interferon alfa-2a), batch B1299B03 EXP 07 2015 has been discovered in Germany.

Dear Doctor Letter (Rote-Hand-Brief) on Septopal® 10 Batch 11L0504 and Septopal® 30 Batch 12C0503 (gentamicin): Recall due to quality deficiency PDF, 94KB, File is accessible Date: 08. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gentamycin

The company Biomet Deutschland GmbH is recalling the a.m. two batches due to a mix-up of the inner sachets. The company cannot rule out the possibility of lacking sterility.

Jevtana® (cabazitaxel): Potential risk of incorrect dosing following preparation of Jevtana® PDF, 64KB, File is accessible Date: 29. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cabazitaxel

The company Sanofi-Aventis Deutschland GmbH calls attention to the instructions for preparation of Jevtana®.

Dear Doctor Letter (Rote-Hand-Brief) on parenteral iron-containing medicinal products: Risk of serious hypersensitivity reactions PDF, 187KB, File is accessible Date: 28. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: iron

The marketing authorisation holders of iron-containing medicinal products for parenteral use are circulating information within a European safety review on the risk of serious hypersensitivity reactions as well as on the precautionary measures …

Information Letter on Increlex® 10 mg/ml solution for injection (mecasermin, recombinant human IGF-1): Interruption in supply PDF, 115KB, File is accessible Date: 18. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mecasermin, recombinant human IGF-1

The company Ipsen Pharma GmbH is sending out information that as of immediately the medicinal product Increlex® 10 mg/ml solution for injection can no longer be supplied in Germany.

Numeta G 16% E® (nutrient solution for term infants and children up to 2 years of age): Possible risk of hypermagnesemia PDF, 89KB, File is accessible Date: 09. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: nutrient solution for term infants and children up to 2 years of age

The company Baxter Deutschland GmbH is sending out information that administration of the medicinal product Numeta G 16% E® to term infants and children up to 2 years of age can possibly lead to the risk of hypermagnesemia.

Dear Doctor Letter (Rote-Hand-Brief) on short-acting beta-agonists/beta 2-sympathomimetic agents (SABAs) for obstetric indications - including Partusisten® (fenoterol): Restrictions of indication PDF, 818KB, File is accessible Date: 01. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fenoterol

The company Boehringer Ingelheim communicates important restrictions regarding the use of short-acting beta-agonists/beta 2-sympathomimetic agents (SABAs) for obstetric indications.

Dear Doctor Letter (Rote-Hand-Brief) on Lariam® (mefloquine): Risk of neuropsychiatric and other serious adverse reactions as well as inclusion of new contraindications PDF, 2MB, File is accessible Date: 10. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mefloquine

Important information regarding new contraindications (Blackwater fever, severe impairment of liver function) as well as on the risk of neuropsychiatric and other serious adverse reactions under Lariam® (mefloquine) for malaria …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing risperidone or paliperidone: Risk of an intraoperative floppy iris syndrome (IFIS) PDF, 817KB, File is accessible Date: 09. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: risperidone, paliperidone

Important information on the risk of an intraoperative floppy iris syndrome (IFIS) in connection with administration of risperidone or paliperidone to patients undergoing cataract surgery.

Information Letter on the new anticoagulants Eliquis® (apixaban), Pradaxa® (dabigatran etexilate) and Xarelto® (rivaroxaban): Reducing the risk of haemorrhages PDF, 108KB, File is accessible Date: 06. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: apixaban

The marketing authorisation holders request observation of risk factors for haemorrhages as well as of dosage instructions, contraindications, warnings and precautionary measures for use in order to reduce the risk of haemorrhages.

Information Letter on clopidogrel: Risk of acquired haemophilia PDF, 145KB, File is accessible Date: 04. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: clopidogrel

The marketing authorisation holders are circulating information on a small number of cases of acquired haemophilia associated with clopidogrel treatment in patients without a history of haemostasis.

Zyvoxid® 2 mg/ml solution for injection (linezolid): limited supply with immediate effect PDF, 116KB, File is accessible Date: 30. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that with immediate effect the medicinal product Zyvoxid® 2 mg/ml solution for injection is available again to a limited extent.

Dear Doctor Letter (Rote-Hand-Brief) on Imnovid® (pomalidomide): Information on important aspects of clinical use PDF, 591KB, File is accessible Date: 28. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pomalidomide

The marketing authorisation holder Celgene is circulating information on important aspects regarding the clinical use of the new medicinal product Imnovid® (pomalidomide).

Dear Doctor Letter (Rote-Hand-Brief) on Neupogen® (filgrastim) and Neulasta® (pegfilgrastim): Risk of capillary leak syndrom PDF, 567KB, File is accessible Date: 26. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: filgrastim

The marketing authorisation holder Amgen GmbH is circulating information on an adverse effect, the capillary leak syndrome (CLS), associated with the treatment of patients with cancer and/or healthy donors with Neupogen® (filgrastim) or Neulasta®

Information Letter on oral ketoconazole-containing medicinal products (Nizoral® tablets): Suspension of marketing authorisation due to serious liver damage
PDF, 75KB, File is accessible
Date: 22. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoconazole

After an EU-wide review of the risk of hepatotoxicity under ketoconazole for treatment of fungal infections, the EMA recommends the suspension of the marketing authorisation for Nizoral® tablets (oral ketoconazole-containing medicinal …

Zyvoxid® 2 mg/ml solution for injection (linezolid): Temporary shortage
PDF, 148KB, File is accessible
Date: 15. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that the medicinal product Zyvoxid® 2 mg/ml solution for injection can currently not be supplied. This shortage is the result of manufacturing problems of one of the external …

Mucosolvan® Solution for injection (ambroxol hydrochloride)
PDF, 87KB, File is accessible
Date: 09. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ambroxol hydrochloride

Information on mixing with commercially available 5% glucose solution for infusion.

LInformation Letter on Roferon®-A (interferon alfa-2a)
PDF, 2MB, File is accessible
Date: 07. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: interferon alfa-2a

The marketing authorisation holder Roche Pharma is circulating an information letter on a temporary shortage in the supply of Roferon®-A due to relocation of the production site.

Information Letter on PegIntron® (peginterferon alfa-2b)
PDF, 64KB, File is accessible
Date: 02. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: peginterferon alfa-2b

Information on the correct use of the new pre-filled injection pen.

Dear Doctor Letter (Rote-Hand-Brief) on Erivedge® (vismodegib) PDF, 3MB, File is accessible Date: 31. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vismodegib

Important information for safe use, including information on contraceptive programmes.

Information Letter on VOTRIENT® (pazopanib)
PDF, 169KB, File is accessible
Date: 30. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pazopanib

Important change to frequency of serum liver test monitoring for hepatotoxicity.

DepoCyte® 50 mg injectable suspension (liposomal cytarabine for intrathecal injection): Back on the market as of 1 August 2013
PDF, 175KB, File is accessible
Date: 25. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: liposomal cytarabine

As of 1 August 2013, DepoCyte® will be available again regularly on the German market.

Dear Doctor Letter (Rote-Hand-Brief) on Pedea® (ibuprofen as solution for injection): Shortage PDF, 401KB, File is accessible Date: 22. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ibuprofen

A temporary shortage in the supply of the medicinal product Pedea® for treatment of a haemodynamically significant patent ductus arteriosus Botalli in preterm newborn infants less than 34 weeks of gestational age has arisen due to the …

PlasmaVolume Redibag® by the company Baxter: Voluntary recall of the medicinal product PDF, 116KB, File is accessible Date: 18. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyethyl starch

The marketing authorisation holder Baxter is circulating information that its medicinal product PlasmaVolume Redibag® (active substance: hydroxyethyl starch (HES)) is being recalled voluntarily from the market and requests to stop using this …

Information Letter on Zofran® (ondansetron) and generic medicinal products: Risk of QTc prolongation PDF, 548KB, File is accessible Date: 18. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ondansetron

This communication contains updated information regarding intravenous use of ondansetron for prevention and treatment of chemotherapy-induced nausea, retching and vomiting (CINV), as well as new recommendations for repeated administration and …

Medicinal products containing diclofenac: Cardiovascular risks PDF, 249KB, File is accessible Date: 16. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: diclofenac

The marketing authorisation holders of systemically acting medicinal products containing diclofenac are sending out information that new contraindications and warnings for these medicinal products have been decided following the Europe-wide …