Pharmacovigilance

Recall of the one batch of Neurobion 100 mg + 100 mg + 1 mg solution for injection

22.07.2014

Merck d.o.o., the marketing authorisation holder for Neurobion 100 mg + 100 mg + 1 mg solution for injection has in collaboration with the Agency for Medicinal Products and Medical Devices initiated a recall of the batch 180707 of this medicine.
The recall is due to an error on the inner and outer labelling of the medicine, where there is “subcutaneous use” instead of “intramuscular use”. The package leaflet is correctly labelled with “intramuscular use”.

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Notice about temporary interruption of distribution and use of the batch HC 68E of Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan)

18.07.2014

Pfizer Croatia d.o.o., the marketing authorisation holder for Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan) has upon Agency’s request initiated a temporary procedure of interruption and use of the batch HC 68E of this medicine. The procedure is due to a suspected quality defect report on the discovered turbid solution that HALMED received on 16 July 2014 by a healthcare professional.The interruption of use of this medicine will be in effect until the results of the extraordinary quality control have been achieved and conclusions on the discovered quality defect made, which will be promptly made publicly available.
The temporary interruption of dispensation and use relates only to the batch HC 68 of this medicine, whereas other available batches may be further dispensed and used.
Detailed information is available under the link below.

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Dear Healthcare Professional Letter on association of Scintimun (besilesomab) with potential risk of human anti-mouse antibody (HAMA) forming by hypersensitivity reaction and acute hypotension

01.07.2014

CIS bio international and Marti Farm d.o.o. have in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals about important information associated with the use of Scintimun (besilesomab).
Summary
• Due to potential risk of human anti-mouse antibody forming (HAMA) that may lead to a type III hypersensitivity reaction, HAMA test should be carried out in all patients before use of Scintimun. The positive result is contraindicated for use of this medicine.
• Hypersensitive reactions may be in the whole range from mild allergic reactions to those life-threatening (including anaphylactic and anaphylactoid reactions).
• Due to acute hypotension risk, adequate therapeutic measures should be available in place in case the acute hypotension occurs as an individual reactions or associated with any clinical sign of the hypersensitivity reaction. The reanimation equipment should be available in the immediate proximity (i.e. ambulance, intensive care unit, etc.).
Detailed information is accessible under the link below.

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Notice on recall of one batch of Etoposide Pfizer 20 mg/ml concentrate for solution for infusion (etoposide) due to an error in the product name in the package leaflet and labelling

26.06.2014

Pfizer Croatia d.o.o., the marketing authorisation holder for Etoposide Pfizer 20 mg/ml concentrate for solution for infusion (etopodide), has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the recall of the batch HW52C of this medicine. The recall is due to an error in the product name in the package leaflet and labelling.

Detailed information is accessible under the link below.

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Information about the recovery of the supply chain with a batch of Engerix B for children 10 micrograms/0.5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV)

18.06.2014

Following to the Notice about the temporary interruption of distribution and use of the batch of Engerix B for children 10 microgram/0,5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV), published on the 3rd June 2014, the Agency for Medicinal Products and Medical Devices (HALMED) is informing hereby about the recovery of the supply chain with the batch AHBVC 262 CD of this medicine.
Detailed information is accessible under the link below.

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Information about counterfeited Kaletra (lopinavir, ritonavir) in Germany

17.06.2014

The Agency for Medicinal Products and Medical devices (HALMED) has received an information about a suspected counterfeit of Kaletra (lopinavir, ritonavir) in Germany. This medicine is used in treatment of human immunodeficiency (HIV-1) infection.
The suspected counterfeited medicine has been reported by a parallel trade company from Germany, who discovered during the check up of purchased quantities a non-conformity in labelling of the outer package and the package leaflet with the information figuring on the original product packaging.
The following batches are affected by the suspected counterfeit: 276268D, 345118D, 336398D. The manufacturer’s investigation is in the course and further distribution of these batches from the stock has been suspended.
Detailed information is accessible under the link below

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Dear Healthcare Professionals Letter on potential life-threatening adverse reactions after accidental exposure to fentanyl-containing transdermal patches (Durogesic, Fentanil Sandoz, Matrifen, Fentagesic)

17.06.2014

Johnson&Johnson S.E. d.o.o., Sandoz d.o.o., Takeda Pharmaceuticals Croatia d.o.o. and Pliva Hrvatska d.o.o., marketing authorisation holders for fentanyl-containing transdermal patches, have, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals about on potential life-threatening adverse reactions after accidental exposure to these medicines.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.

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European Medicines Agency starts review to evaluate risk of ibuprofen-containing medicines taken over long periods

17.06.2014

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (such as those taken by mouth but not topical medicines like creams and gels).
The cardiovascular risks being evaluated concern high-dose ibuprofen (2,400 mg per day) taken regularly for long periods. Ibuprofen is usually taken at lower doses and for short periods of time. There is therefore no suggestion of a similar cardiovascular risk with ibuprofen as used by the overwhelming majority of patients. Ibuprofen is one of the most widely used medicines for pain and inflammation and has a well-known safety profile, particularly at usual doses.
Detailed information is accessible under the link below.

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