Pharmacovigilance

Notice on temporary discontinuation of supply chain and use of batches 15HK11F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofloxacin Kabi 200 mg/100 ml solution for infusion.

26.05.2015

Fresenius Kabi d.o.o., the marketing authorisation holder for Ciprofloxacin Kabi 400 mg/200 ml solution for infusion, Fresenius Kabi d.o.o., has initiated upon request of the Agency for Medicinal Products and Medical Devices (HALMED) a procedure of temporary disruption of distribution and use of the batches: 15IB515P2 of Ciprofoxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofoxacin Kabi 200 mg/100 ml solution for infusion in the Republic of Croatia.

The procedure of discontinuation of distribution and use of these batches has been initiated over concern on a suspected quality defect based on an increased number of suspected adverse reactions to these medicines reported to HALMED in the last several weeks.

More information is accessible under the link below.

more

CMDh updated advice on use of high-dose ibuprofen

22.05.2015

The CMDh has endorsed by consensus updated advice on the use of high-dose ibuprofen. This follows a review carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a small increased risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day). The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.

Further information is accessible under the link below.

more

Dear Healthcare Professional Letter on the risk of clinically important arrhythmias when Harvoni (sofosbuvir+ledipasvir) or combination of Daklinza (daclatasvir) and Sovaldi (sofosbuvir) are used together with amiodarone

11.05.2015

The Agency for Medicinal Products and Medical Devices (HALMED) would like to inform healthcare professionals on the risk of clinically important arrhythmias when Harvoni (sofosbuvir+ledipasvir) or combination of Daklinza (daclatasvir) and Sovaldi (sofosbuvir) are used together with amiodarone.

Further information is accessible under the link below.

more

Dear Healthcare Professional Letter on the new list of compatible appliances for blood glucose determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin)

14.04.2015

Agmar d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a Dear Healthcare Professional Letter on the new list of compatible appliances for blood glucose determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin).

Further information is accessible under the link below.

more

PRAC recommends updating advice on use of high-dose ibuprofen

13.04.2015

European Medicines Agency’s (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day). The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.

No increase in cardiovascular risk is seen with ibuprofen at doses up to 1,200 mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union (EU).

The PRAC concluded that the benefits of ibuprofen outweigh the risks but recommended updating advice on the use of high-dose ibuprofen to minimise the cardiovascular risk.

Further information is accessible under the link below.

more

Dear Healthcare professional Letter on the new measures associated with the use of Linoladiol 0.01% vaginal cream (estradiol) due to a potential risk of systemic adverse reactions to estradiol

19.03.2015

Remedia d.o.o. , in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) is sending a letter to healthcare professionals to inform them of the new measures associated with the use of Linoladiol 0.01% vaginal cream (estradiol) due to a potential risk of systemic adverse reactions to estradiol.

Further information is accessible under the link below.

more

For Patients and Public

For Health Care Professionals

For Industry Representatives