Information on the safety of medicines

Intravenous forms of tranexamic acid: severe, including fatal, adverse reactions due to unintended intrathecal administration: TRANEXAMIC ACID, solution for injection, 50 mg/ml; RC: UA/17082/01/02 and TRANEXAMIC ACID, solution for injection, 100 mg/ml, RC: UA/17082/01/01, applicant: Joint Stock Company “Lekhim-Kharkiv”, Ukraine

Information letter to the healthcare professionals Medicines containing finasteride and dutasteride: new measures to minimize the risk of suicidal thoughts

Important measures to minimize the serious consequences of a known adverse reaction (agranulocytosis) when using analgesics containing metamizole: ANALGIN, solution for injection, 500 mg/ml; ANALGIN FOR CHILDREN, rectal suppositories, 0.1 g or 0.25 g; RENALGAN® solution for injection; RENALGAN® tablets, applicant: PJSC “Lekhim – Kharkiv”.

A reminder about the risks of treatment and the need for monitoring and observation of patients taking medicines containing amiodarone (AMIODARONE, 0.2 g tablets)

Reminder about restrictions on the use of antibacterial drugs belonging to fluoroquinolones (risk of long-term severe side reactions)

Reminder about restrictions on the use of antibacterial agents belonging to the class of fluoroquinolones

New Risk of Regurgitation development / heart valve failure associated with fluoroquinolones for systemic and inhalation use.

On amendments to the instruction leaflet for medical use of the medicinal product Gabapentin 300 mg hard capsules, 10 capsules in a blister, 2 blisters in a carton, the applicant/manufacturer: PJSC «Technolog».

On amendments to the instruction leaflet for medical use of the medicinal product Ciprofloxacin 250 mg tablets, 10 tablets in a blister or 900 tablets in blisters in a box; 500 mg tablets in a blister, 10 tablets in a carton or 700 tablets in a blister in a box; Levofloxacin (ЛЕВОФЛОКСАЦИН) 250 and 500 mg tablets, 10 tablets in a blister, 1 blister in a carton, the applicant/manufacturer: PJSC «Technolog».