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PRAC May 2020 – New measures to avoid handling errors with Leuprorelin depot medicines and completion of signal evaluation for ibuprofen, ketoprofen and fixed-dose combinations

During its meeting of May 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended measures to avoid handling errors in the preparation and administration of leuprorelin depot medicines.

Coronavirus: good practices when changing consumables used with COVID-19 patient ventilators

In order to help healthcare professionals and support hospitals in their processes, the FAMHP is publishing guidelines on changing consumables (filters, etc.) used in the ventilation of COVID-19 patients.

Coronavirus: reminder of risk of serious adverse effects associated with chloroquine and hydroxychloroquine

The European Medicines Agency (EMA) recommends that healthcare professionals monitor cardiac adverse effects and consider pre-existing heart conditions in COVID-19 patients treated with hydroxychloroquine or chloroquine. It should also be borne in mind that there may be an increased risk of cardiac adverse effects when these treatments are administered in high doses or in combination with certain medicinal products, such as azithromycin.

Flash VIG-news: risk of haemolysis associated with the use of hydroxychloroquine (PLAQUENIL) in the treatment of COVID-19

Physicians should be alert to the signs and symptoms of haemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency treated with hydroxychloroquine for the treatment of COVID-19.

Flash VIG-news: pay attention to the elimination half-life of hydroxychloroquine and chloroquine and to the risks of drug interactions

As mentioned in the AFMPS news of 24.03.2020, hydroxychloroquine (Plaquenil) and chloroquine are used in certain circumstances to treat patients with COVID-19. The FAMHP reminds everyone of the risks of drug interactions posed by these treatments.

Coronavirus: hydroxychloroquine, chloroquine and Kaletra (lopinavir & ritonavir) are subject to controlled distribution in Belgium to enhance monitoring of treatments

Hydroxychloroquine, chloroquine and Kaletra (lopinavir & ritonavir) are used to treat patients with COVID-19. The FAMHP has quarantined available stocks of these medicines to control their distribution, improve monitoring of their use and limit the risks to patients. Do not take any of these medicines without medical supervision.

Operation PANGEA XIII: Belgian customs and the FAMHP seize 203 packages containing over 23 000 illicit or counterfeit products

The FAMHP, in collaboration with Belgian customs, took part in the international Operation PANGEA XIII from 3 to 10 March 2020. This operation, coordinated by INTERPOL, specifically targets the interception of illicit and counterfeit medicinal products and devices. In Belgium, inspections were performed at the Zaventem and Bierset control points.

Start of survey about the use of benzodiazepines and related substances for sleep disorders in Belgium

As announced, the Federal Agency for Medicines and Health Products (FAMHP) is holding an online survey to collect information about the use of benzodiazepines and related substances for sleep disorders in the Belgian population. The survey starts today and will run for one month.

PRAC February 2020 : recommendations for cyproterone containing medicinal products.

During its meeting of 10 – 13 February 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends restrictions in use of cyproterone due to meningioma risk.

www.notifieruneffetindesirable.be - www.eenbijwerkingmelden.be: more practical and user friendly online forms

The FAMHP has created an online form for healthcare professionals to notify any adverse effects of medicinal products for human use. This new format incorporates the patient notification form for that has been online since March 2019. From now on, anybody can notify adverse effects of medicinal products using simplified online forms available at a single address: www.notifieruneffetindesirable.be or www.eenbijwerkingmelden.be.

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