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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.