The State Expert Center of the Ministry of Health of Ukraine (the Center) recommends supplementing the instructions for medical use of medicinal products containing tobramycin and pramipexole.
The relevant recommendations have been published on the Center's website with reference to information from the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA): http://surl.li/rmenl
In particular, it is recommended:
- tobramycin – update the instructions for medicinal products containing tobramycin. The benefit/risk balance for such medicinal products remains unchanged. At the same time, a warning about an increased risk of hearing impairment (aminoglycoside-associated ototoxicity in patients with mitochondrial rRNA mutations) must be added to the instructions. In addition, registration certificate holders of medicinal products containing tobramycin are recommended to update the information on the interaction of tobramycin with azithromycin, which may result in reduced efficacy. Furthermore, registration certificate holders must submit new data on the use of tobramycin in patients with cystic fibrosis who have transplanted lungs: http://surl.li/smkpo
- pramipexole – update the instructions for medicinal products containing pramipexole. The benefit/risk balance of such medicinal products remains unchanged for the approved indications. At the same time, following an analysis of safety reports, it was emphasized that the lowest effective dose should be used in the treatment of idiopathic restless legs syndrome. It is also recommended to add “augmentation of restless legs syndrome” as a warning and as an adverse reaction with a frequency of “very common”: http://surl.li/smlmf
Reminder! According to paragraph 8 of Section IV of the Procedure for Conducting Expert Evaluation, applicants (holders of registration certificates for medicinal products) must make amendments to the instructions for medical use of medicinal products upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
