News and Educations

The PRAC news – October 2013

14.10.2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave new recommendations on its October 2013 meeting about the safe use of medicines in European Union Member States.
The PRAC has concluded that the benefits of combined hormonal contraceptives continue to outweigh their risks. The PRAC confirmed the recommendation that hydrohyethyl-starch (HES) solutions must no longer be used to treat patients with sepsis or burn injuries or critically ill patients. In addition, the review of valproate-containing medicines and related substances and their use in pregnant woman has started.
Detailed information is accessible under the following link.

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PRAC confirms that hydroxyethil-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients

11.10.2013

The European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has completed the review of hydroxyethil-starch-containing (HES) solutions following an assessment of new information and commitments for additional studies and risk minimisation activities. The PRAC confirmed that HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients, because of an increased risk of kidney injury and mortality. HES solutions may, however, continue to be used in patients to treat hypovolaemia (low blood volume) cause by acute blood loss, provided that appropriate measures are taken to reduce potential risks and that additional studies are carried out.
You may find more detailed information under the following link:

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Dear Doctor Letter about the possible vaccine leackage due to crack or defects on the plastic junction connecting the needle and syringe in vaccines with Readyject syringe for products FSME-IMMUN 0,25 ml Junior and FSME-IMMUN 0,5 ml

10.10.2013

The company Agmar d.o.o., the marketing authorisation holder for vaccines FSME-IMMUN 0,25 ml Junior, suspension for injection in pre-filled syringe, vaccine against tick-borne encephalitis, inactivated, is sending a letter on behalf of the manufacturer, Baxter, and in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) to doctors about an important information related to use of vaccines FSME-IMMUN 0.25 ml Junior and FSME-IMMUN 0,5 ml with Readyject syringe (pre-filled syringe with attached syringe).
Deatailed information and the Dear Doctor Letter are accessible under the following link:

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Dear Healthcare Professional Letter about the introduction of new warning on possible serotonin syndrome that may occur under co-administration of medicinal products Fentanyl or Durogesic transdermal patches with serotonergic medicines

09.10.2013

The marketing authorisation holder, Johnson & Johnson S.E. d.o.o. is sending a letter, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) to healthcare professionals with the aim to warn about a possible occurrence of serotonin syndrome in cases where serotonergic medicines are administered concomitantly with the marketing authorisation holder’s fentanyl-containing medicinal products Fentanyl and Durogesic Transdermal Patch.

The marketing authorisation holder undertook a review to assess the available evidence for the possibility of serotonin syndrome when serotonergic medicines are administered concomitantly with fentanyl-containing medicinal products that are currently licensed by tha marketing authorisation holder. Based on the results and conclusions of this review, updates to the Summary of Product Characteristic for medicinal products Fentanyl and Durogesic Transdermal Patch have been made to include a warning regarding the potential for serotonin syndrome to occur when these medicinal products are used concurrently with other serotonergic medicines.

You may view the Dear Healthcare Professional Letter under the following link.

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European Medicines Agency begins to publish recommendations based on safety signals

07.10.2013

The European Medicines Agency (EMA) has published the first overview listing the recommendations stemming from the assessment of safety signals by the Pharmacovigilance Risk Assessment Committee (PRAC). The document covers all safety signals discussed during the September 2013 PRAC meeting and the recommendations given for each of them. It includes PRAC recommendations for centrally and nationally authorised medicines.
The evaluation of safety signals by the PRAC has been implemented with the new pharmacovigilance legislation. A cumulative list of all signals discussed at the PRAC since September 2012 available on the EMA web pages or under the following link.

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Dear Healthcare Professional Letter about the risk of appearance of an intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients treated with risperidone or paliperidone

05.10.2013

Janssen-Cilag International NV and Johnson & Johnson S.E. d.o.o., the marketing authorisation holders in the Republic of Croatia for medicinal products Xeplion 25 mg, 50 mg, 75 mg, 100 mg suspension for injection with prolonged release (paliperidone), Invega 1,5 mg, 3 mg, 6 mg, 12 mg tablets with prolonged release (paliperidone), Rispolept Consta 25 mg, 37,5 mg, 100 mg powder and solvent for suspension for injection with prolonged release for intramuscular application (risperidone), Rispolept 1 mg, 2 mg, 3 mg, 4 mg film-coated tablets (risperidone) and Rispolept 1 mg/ml solution for oral use (risperidone), have, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals about the risk of appearance of an intraoperative floppy iris syndrome during cataract surgery in patients treated with risperidone paliperidone.

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Stronger promotion of ADR reporting in accordance with the new pharmacovigilance legislation

04.10.2013

The promotion and facilitation of the reporting side effects from health care professionals and patients represent one of the requirements of the new pharmacovigilance legislation setting out stricter rules for monitoring the safe use of medicines with the aim to ensure better prevention, signal detection, as well as adverse reaction evaluation, and thus reinforce the contribution to patients' safety.
In accordance with the aforementioned pharmacovigilance legislation, in the beginning of September 2013 the Agency for Medicinal Products and Medical Devices (HALMED) started a public educational campaign with the aim to promote the importance of reading patient information leaflet and ADRs reporting among patients and medicines users. The objective of the campaign is to inform patients, that alongside the information they get from qualified health care providers, additional information may be obtained by reading the package leaflet. By reporting adverse reactions, patients are also encouraged to get actively involved in the treatment and monitoring of the safe use of medicines.
In accordance with the aforementioned approach, the EU introduced a new labelling procedure for medicinal products that are subject to intensive monitoring by competent authorities.
Medicinal products subject to additional monitoring will have in their summary of product characteristics and package leaflet a black symbol in the form of a black inverted equilateral triangle and a short sentence explaining the symbol.
The black triangle will be used in all EU Member States, in order to identify medicinal products subject to additional monitoring. This symbol will start appearing in the summaries of product characteristics and package leaflets concerned from the autumn of 2013.

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Submission of notification on placing medicinal product on the market

01.10.2013

Following the information about the submission of notification on placing medicinal products on the market, that was posted on HALMED’s web pages on 16 August 2013, we remind the marketing authorisation holders who did not submit the information earlier, to submit to HALMED the fulfilled table that should contain the information about the last date of the product on the market for all holder’s medicinal products having a valid marketing authorisation. The aforementioned information is necessary, so that HALMED who is responsible for monitoring the medicinal product supply in Croatia, can have an overview of medicinal products on the market. Based on the submitted information, HALMED may, in case of disruption of supply or shortage of medicine, undertake appropriate measures with the aim to ensure a regular supply chain in the Republic of Croatia. The information is also necessary for monitoring of deadlines for implementation of so-called Sunset Clause.

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