In accordance with paragraph 8 of Section IV of the Procedure for Conducting Expert Evaluation, the applicant must make amendments to the instructions for medical use of the medicinal product 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 about the medicinal product corresponds to current scientific knowledge.
Having considered the available evidence from EudraVigilance, the literature and the cumulative review submitted by the registration certificate holders (RCHs) of medicinal products containing dulaglutide, exenatide, insulin degludec/liraglutide, liraglutide, insulin glargine/lixisenatide, lixisenatide, semaglutide, tirzepatide, the PRAC decided that the registration certificates for the medicinal products Ozempic, Ribelsox, Vegeta, Victoza, Saxenda, Xultofi (Novo Nordisk A/S), Byetta, Baidureon (AstraZeneca AB), Munjaro, Trulicity (Eli Lilly Nederland B. V.) and Lyxumia, Suliqua (Sanofi Winthrop Industrie), must be updated by amending the instructions for medical use, as described below (new text is underlined).
“Special precautions for use” section
For medicinal products containing semaglutide, liraglutide, insulin degludec/liraglutide, dulaglutide, lixisenatide, insulin glargine/lixisenatide, exenatide.
Aspiration during general anesthesia or deep sedation
Cases of pulmonary aspiration during general anesthesia or deep sedation have been reported in patients receiving GLP-1 receptor agonists. Therefore, before procedures involving general anesthesia or deep sedation, the increased risk of residual gastric contents due to delayed gastric emptying should be taken into account (see the section “Adverse reactions”).
For medicinal products containing tirzepatide (tirzepatide).
Aspiration during general anesthesia or deep sedation
Cases of pulmonary aspiration during general anesthesia or deep sedation have been reported in patients receiving GLP-1 receptor agonists. Therefore, before procedures involving general anesthesia or deep sedation, the increased risk of residual gastric content due to delayed gastric emptying should be taken into account (see the section “Pharmacological properties”).
List of medicinal products containing semaglutide (semaglutide), liraglutide (liraglutide), insulin degludec (insulin degludec)/liraglutide (liraglutide), insulin glargine (insulin glargine)/lixisenatide (lixisenatide) and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 19.12.2024)
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE CORRESPONDING APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINKS:
