2019 – State Expert Center of the Ministry of Health of Ukraine

Azax

21.12.2019 2740

Letter to healthcare professionals on the increased risk of relapse of hematological malignancies and mortality with long-term use of azithromycin outside the registered indications in patients after hematopoietic stem cell transplantation, based on the results of the ALLOZITHRO study. generated automatically

Seroquel XR

21.12.2019 3036

An information material for healthcare professionals on the safe use of quetiapine: dosing regimens in bipolar depression, monitoring of metabolic parameters (body weight, glycemia, lipids), and the procedure for reporting adverse reactions. compiled automatically

Medocyprin

12.12.2019 2593

Informational letter to healthcare professionals on the risk of prolonged, disabling, and potentially irreversible serious adverse reactions associated with systemic and inhaled fluoroquinolones, as well as restrictions on their prescription. Contains updated recommendations and warnings for healthcare professionals. generated automatically

Broncho-Munal

12.12.2019 3305

Notice to healthcare professionals on the final decision of the European Commission on medicinal products based on bacterial lysates for the treatment of respiratory tract diseases: the favorable benefit/risk balance in the prevention of recurrent respiratory tract infections in adults and children has been confirmed, and an inappropriate indication has been removed. generated automatically

Azithromycin

09.12.2019 3467

Letter to healthcare professionals on the increased risk of relapse of hematological malignancies and mortality with long-term use of azithromycin outside the registered indications in patients after hematopoietic stem cell transplantation. Contains the results of the ALLOZITHRO study and recommendations on reporting adverse reactions. compiled automatically

IMBRUVICA

29.11.2019 2825

Letter to healthcare professionals on the update of the package insert for ibrutinib: addition of a warning about the risk of acute cerebrovascular accident, transient ischemic attacks and ischemic stroke. Contains a description of changes to the sections "Special warnings and precautions for use" and "Adverse reactions" and the procedure for reporting adverse reactions. generated automatically

ESBRIET

22.11.2019 5135

Information letter for healthcare professionals on updated safety data for Esbriet (pirfenidone) in connection with reports of drug-induced liver injury, including fatal cases. Contains a description of the risk, recommendations for monitoring liver function, and the procedure for reporting adverse reactions. generated automatically

TACTROL

20.11.2019 2976

Educational material for healthcare professionals on treatment with fingolimod (TAKTROL): patient selection, recommended steps before, during and after therapy, reporting of adverse reactions, and a patient reminder. generated automatically

Ikervis

05.09.2019 2770

Information letter for healthcare professionals about a technical inaccuracy in the translation in the “Pharmacological properties” section of the instructions for medical use of a cyclosporine-based medicinal product for the treatment of severe keratitis in dry eye syndrome. Contains the updated section of the instructions and the procedure for reporting adverse reactions. compiled automatically

Xarelto®

30.08.2019 4168

Information letter for healthcare professionals on the safety of direct oral anticoagulants in patients with antiphospholipid syndrome: due to an increased risk of recurrent thrombotic events, their use is not recommended, and switching to a vitamin K antagonist should be considered. generated automatically