Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
A/MICHIGAN/45/2015 (H1N1)PDM09 – LIKE STRAIN; A/SINGAPORE/INFIMH-16-0019/2016 (H3N2) - LIKE VIRUS; B/COLORADO/06/2017- LIKE VIRUS (B/VICTORIA/2/87 LINEAGE); B/PHUKET/3073/2013 LIKE STRAIN
SANOFI ISRAEL LTD
J07BB02
SUSPENSION FOR INJECTION
B/PHUKET/3073/2013 LIKE STRAIN 60 MCG / 0.7 ML; B/COLORADO/06/2017- LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) 60 MCG / 0.7 ML; A/SINGAPORE/INFIMH-16-0019/2016 (H3N2) - LIKE VIRUS 60 MCG / 0.7 ML; A/MICHIGAN/45/2015 (H1N1)PDM09 – LIKE STRAIN 60 MCG / 0.7 ML
S.C, I.M
Required
SANOFI PASTEUR, USA
INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN
Active immunisation in adults 65 years of age and older for the prevention of influenza disease. בקשה לשינוי משטר מינון: 9/3/2022Active immunisation in adults 60 years of age and older for the prevention of influenza disease.
2022-02-03
_EFLU-SPC-12.23 V10.0 _ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Efluelda , suspension for injection in pre-filled syringe Quadrivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus (inactivated, split) of the following strains*:A/Victoria/4897/2022 (H1N1) pdm09-like strain (A/Victoria/4897/2022, IVR-238) 60 micrograms HA** A/Darwin/9/2021(H3N2)-like strain (A/Darwin/9/2021, SAN-010) 60 micrograms HA** B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type) 60 micrograms HA** B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type) ............ 60 micrograms HA** Per 0.7 ml dose * propagated in embryonated chicken eggs ** haemagglutinin This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2023/2024 season. Efluelda may contain traces of eggs, such as ovalbumin, formaldehyde which are used during the manufacturing process (see Section 4.3). For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection, in a pre-filled syringe Efluelda, after shaking gently, is a colourless opalescent liquid. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Efluelda is indicated for active immunisation in adults 65 years of age and older for the prevention of influenza disease. The use of Efluelda should be based in accordance with official recommendations on vaccination against influenza. 4.2 Posology and method of administration Posology In adults 65 years of age and older: one dose of 0.7 ml. _Paediatric population _ The safety and effectiveness of Efluelda in children less than 18 years of age have not been established. Method of administration The preferred route of administration for this vaccine is intramuscular although it may also be given subcutaneously. The recommended site for intramuscular injection is the deltoid region. The vaccine should not be injected into the gluteal region, or into areas where there may be a Belgenin tamamını okuyun