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Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing temozolomide: risk of severe liver toxicity PDF, 213KB, File is accessible Date: 13. December 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temozolomide

The companies concerned point out that cases of liver injury, including liver failure with lethal outcome, have been reported in patients treated with medicinal products containing temozolomide. The liver toxicity may not appear until several …

Dear Doctor Letter (Rote-Hand-Brief) on Iclusig® (ponatinib): Updated information on the risk of vascular occlusion PDF, 95KB, File is accessible Date: 09. December 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ponatinib

Extension of warnings to include the risk of severe vascular occlusion associated with ponatinib.

Dear Doctor Letter (Rote-Hand-Brief) on EFIENT® (prasugrel): increased risk of serious bleeding PDF, 910KB, File is accessible Date: 03. December 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: prasugrel

The company Lilly Deutschland GmbH is circulating information that patients with unstable angina pectoris (UA)/NSTEMI receiving EFIENT® prior to diagnostic coronary angiography have an increased risk of serious bleeding.

Dear Doctor Letter (Rote-Hand-Brief) on Oncaspar® solution for injection (pegasparaginase): Possible quality deficiency PDF, 364KB, File is accessible Date: 19. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegasparaginase

The company Sigma-Tau Arzneimittel GmbH is circulating information that individual containers from different batches have exhibited fine cracks that can lead to leakage (assumed incidence: one in every 5,000 injection vials). Due to these fine …

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.