Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/6/2021, IVR-227) / A/Victoria/4897/2022 (H1N1) pdm09-like strain (A/Victoria/4897/2022, IVR-238) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) / Influenza virus B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26)
Seqirus Netherlands B.V.
J07BB02
influenza vaccine (surface antigen, inactivated, adjuvanted)
Vaccines
Influenza, Human
Prophylaxis of influenza in the elderly (65 years of age and older).Fluad Tetra should be used in accordance with official recommendations.
Revision: 7
Authorised
2020-05-20
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUAD TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Influenza vaccine (surface antigen, inactivated, adjuvanted) This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Fluad Tetra is and what it is used for 2. What you need to know before you receive Fluad Tetra 3. How Fluad Tetra is given 4. Possible side effects 5. How to store Fluad Tetra 6. Contents of the pack and other information 1. WHAT FLUAD TETRA IS AND WHAT IT IS USED FOR Fluad Tetra is a vaccine against flu (influenza). When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu. Fluad Tetra is used to prevent flu in adults 50 years of age and older. The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2023/2024 season. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FLUAD TETRA YOU SHOULD NOT RECEIVE FLUAD TETRA - if you are allergic to • the active substances or any of the other ingredients of this medicine (listed in section 6) • egg or chicken proteins (such as ovalbumin), kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and hydrocortisone, which are trace residues from the manufacturing process. - If you have had a severe allergic Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Fluad Tetra, suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, adjuvanted) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*: PER 0.5 ML DOSE A/Victoria/4897/2022 (H1N1)pdm09-like strain ( A/Victoria/4897/2022 IVR-238) 15 micrograms HA ** A/Darwin/9/2021 (H3N2) -like strain (A/Darwin/6/2021 IVR-227) 15 micrograms HA ** B/Austria/1359417/2021-like strain (B/Austria/1359417/2021 BVR-26) 15 micrograms HA ** B/Phuket/3073/2013-like strain (B/Phuket/3073/2013 BVR‐1B) 15 micrograms HA ** *propagated in fertilised hens’ eggs from healthy chicken flocks and adjuvanted with MF59C.1 **haemagglutinin Adjuvant MF59C.1 containing per 0.5 ml dose: squalene (9.75 mg), polysorbate 80 (1.175 mg), sorbitan trioleate (1.175 mg), sodium citrate (0.66 mg) and citric acid (0.04 mg). This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU recommendation for the 2023/2024 season. Fluad Tetra may contain traces of eggs such as ovalbumin or chicken proteins, kanamycin and neomycin sulphate, formaldehyde, hydrocortisone, cetyltrimethylammonium bromide (CTAB) 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 pre-filled syringe (injection). Milky-white suspension. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza in adults 50 years of age and older. Fluad Tetra should be used in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One 0.5 ml dose. _Paediatr Przeczytaj cały dokument