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Information Letter on Pixuvri® 29 mg powder for concentrate for solution for infusion (pixantrone): Risk of dosing errors PDF, 130KB, File is accessible Date: 19. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pixantrone

The company CTI Life Sciences Limited in Great Britain points out that there is a risk of dosing errors when taking Pixuvri® (active substance: pixantrone), since the dose recommended in the EU is different as compared to that stated in some …

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.