Pharmacovigilance

Information about printing error in the package leaflet of certain batches of Xeloda

16.06.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received a quality defect report for Xeloda (capecitabine). This is due to a printing error in the package leaflet of certain batches of Xeloda.
In the paragraph 1 of the package leaflet “What is Xeloda and what is it used for”, there is an incorrect statement that the medicine contains 150 mf of capecitabine instead of 500 mg capecitabine. The affected batches containing the correct amount of 500 mg of capecitabine per tablet, which ia clearly stated in other parts of the package leaflet and labelling. The following batches have been affected by this quality defect , which means a printing error: B3010B02, B3024B03, X3197B05, X3164B02, X3111B02, X3048B02 and B3038B04.
Detailed information is accessible under the link below.

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Dear healthcare professionals letter on reminder on the Procoralan/Corlentor conditions of use for the symptomatic treatment of chronic stable angina pectoris to avoid potentially dangerous bradycardia

12.06.2014

Servier Pharma d.o.o., local representative of the marketing authorization holder, in collaboration with the Croatian Agency for Medicinal Products and Medical Devices, have sent a letter to healthcare professionals on the emerging safety issue for Procoralan/Corlentor (ivabradine). Preliminary results of the SIGNIFY study have shown a small but statistically significant increase in the combined risk of cardiovascular death and non-fatal myocardial infarction with ivabradine compared with placebo in a pre-specified subgroup of patients with symptomatic angina of CCS class II or more.
Initial data indicate that the adverse cardiovascular outcomes may be mostly associated with the target heart rate being below 60 bpm; however data from the SIGNIFY study are being further evaluated to fully understand its implications for the clinical use of ivabradine.

HALMED encourages health care professionals to strictly adhere to the approved indication of ivabradine, as well as any restrictions on the use of ivabradine listed in the summary of product characteristics, until the outcomes of the assessment are known. In case of any concerns, patients who were treated with ivabradine should contact their doctor for advice.

Detailed information is accessible under the link below.

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Notice about 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)

03.06.2014

GlaxoSmithKline d.o.o., marketing authorisation holder for Engerix B for children 10 microgram/0.5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV), has upon request of the Agency for Medicinal Products and Medical Devices (HALMED) carried out a procedure of temporary distribution and use interruption of the batch AHBVC 262CD of this medicine.
The procedure of temporary distribution and use interruption of this batch of the medicine has been initiated as a caution measure, due to a suspected quality defect reported from a healthcare professional. The suspected quality defect consists in the change in appearance of the medicine (less milky than usual) and presence of precipitate particles that do not dissolve by remaining at the room temperature.
Detailed information is accessible under the link below.

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Information about counterfeit Herceptin (trastuzumab) on the Czech market

26.05.2014

Following the previous information about the counterfeit Herceptin (trastuzumab) on the EU market, the Agency for Medicinal Products and Medical Devices (HALMED) has been informed about a suspected counterfeit Herceptin on the Czech market.
In the Czech Republic, a medicinal product was found to have different labelling of the expiry date and batch number on the inner and outer packaging and to be labelled in different languages. The inner package was labelled with the batch number H0758, whereas indicated batch number on the outer packaging was H4342B01. The inner packaging and the package leaflet were prepared in Romanian and Bulgarian, whereas the outer packaging was prepared in Romanian language.
Detailed information is accessible under the link below.

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Information on recall of falsified Norditropin SimpleXx 10 mg/1,5 ml solution for injection (somatropin) on the German market

23.05.2014

The Agency for Medicinal Products and medical Devices (HALMED) has received the information about a falsified Morditropim SimpleXx 10 mg/1,5 ml solution for injection (somatropin), used for growth failure and disorders on the German market. A falsified batch of the medicine has been discovered, batch No LL38548, shelf life 10/2015, that has never been released by the manufacturer, Novo Nordisk A/S, Denmark. This falsified medicine is suspected to be purchased in an illicit distribution chain in Germany.
Further information is accessible under the link below.

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Dear Healthcare Professional Letter on placing on the market of new medicinal products Silapen K 1 000 000 IU film-coated tablets and Silapen K 1 500 000 IU film-coated tablets

22.05.2014

Belupo, medicines & cosmetics d.d. has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals of placing on the market of new medicines: Silapen K 1 000 000 IU film-coated tablets and Silapen K 1 500 000 film-coated tablets. This medicines will replace Silapen 1 000 000 IU tablets and Silapen 1 500 000 IU tablets, and therefore it might be possible for some time that all of these medicines will be on the market.
Detailed information and the Dear Healthcare Professional Letter is accessible under the link below.

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Information about temporary distribution and use disruption of the batch 37/I of the Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content), Institute of Immunology, 10 doses, suspension for injection

16.05.2014

Institute of Immunology, the marketing authorisation holder for the Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content), Institute of Immunology, 10 doses, suspension for injection, has at request of the Agency for Medicinal Products and Medical Devices (HALMED) temporary interrupted the distribution and use of the batch 37/1 of this vaccine on the Croatian market. There are sufficient quantities of the other on the Croatian market which is not affected by this suspected quality defect and that may be further distributed and used so that the vaccination program is not at risk.
Detailed information is accessible under the link below.

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Information on temporary recall of Cefexin 100 mg/5 ml powder for oral suspension (cefiximum)

30.04.2014

Pliva Croatia d.o.o. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the temporary recall of Cefiksim Jadran 100 mg/5 ml powder for orals suspension (cefiximum). The medicinal product is being temporarily recalled due to unclear graduation of the accompanying syringe graduated in kilograms of body mass instead of being graduated in millilitres of prepared solution, which might lead to a medication error when administering the medicine.
Further information is available under the link below.

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Information on temporary recall of Cefiksim Jadran 100 mg/5 ml powder for oral suspension (cefiximum)

30.04.2014

Jadran Galenski laboratoj d.d. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the temporary recall of Cefiksim Jadran 100 mg/5 ml powder for orals suspension (cefiximum). The medicinal product is being temporarily recalled due to unclear graduation of the accompanying syringe graduated in kilograms of body mass instead of being graduated in millilitres of prepared solution, which might lead to a medication error when administering the medicine.
Further information is accessible under the link below.

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Dear Healthcare Professional Letter on eventual need for earlier re-vaccination with conjugated vaccines in individuals vaccinated with Mencevax ACWY Vaccine, who are highly at risk of exposure to serogroups A, W-135 and Y

25.04.2014

GlaxoSmithKline d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the available persistence data of Mencevax ACWY Vaccine.
Detailed information and the dear Healthcare professional Letter is assessible under th elink below.

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