Pays: Malte
Langue: anglais
Source: Medicines Authority
Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland
J07BB02
INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) 15 µg
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) 15 µg
POM
VACCINES
Authorised
2017-07-21
_ _ Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER _INFLUVAC SUB-UNIT TETRA_, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Influenza vaccine (surface antigen, inactivated) 2023/2024 season READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE VACCINATED, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This vaccine has been prescribed for you or your child. Do not pass it on to others. - If you or your child 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 _Influvac Sub-unit Tetra_ is and what it is used for 2 What you need to know before you or your child use _Influvac Sub-unit Tetra_ 3 How to use _Influvac Sub-unit Tetra_ 4 Possible side effects 5 How to store _Influvac Sub-unit Tetra_ 6 Contents of the pack and other information 1. WHAT _INFLUVAC SUB-UNIT TETRA_ IS AND WHAT IT IS USED FOR _Influvac Sub-unit Tetra_ is a vaccine. This vaccine helps to protect you or your child against influenza (flu), particularly in subjects who run a high risk of associated complications. _Influvac Sub-unit Tetra_ is indicated in adults and children from 6 months of age. The use of _Influvac Sub-unit Tetra_ should be based on official recommendations. When a person is given the vaccine _Influvac Sub-unit Tetra_ , the immune system (the body’s natural defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu. Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Therefore, this is why you or your child might need to be vaccinated every year. The greatest risk of catching flu is during the cold months between October and March. If you or your child were not vaccinated in the autumn, it is still sensible to Lire le document complet
1/9 1. NAME OF THE MEDICINAL PRODUCT _Influvac Sub-unit Tetra_ , suspension for injection in pre-filled syringe (influenza vaccine, surface antigen, inactivated). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (inactivated) (haemagglutinin and neuraminidase) of the following strains*: - 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/9/2021, SAN-010) 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, wild type) 15 micrograms HA ** per 0.5 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin. _ _ This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2023/2024 season. For a full list of excipients see section 6.1. _Influvac Sub-unit Tetra_ may contain traces of eggs (such as ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin, which are used during the manufacturing process (see section 4.3). 3. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. A colourless clear liquid. _ _ 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Prophylaxis of influenza, especially those who run an increased risk of associated complications. _Influvac Sub-unit Tetra_ is indicated in adults and children from 6 months of age. The use of _Influvac Sub-unit Tetra_ should be based on official recommendations. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: 0.5 ml. _Paediatric population _ Children from 6 months to 17 years of age: 0.5 ml. Children less than 9 years of age, who have not previously been vaccinated with a seasonal influenza vaccine: a second dose of 0.5 ml should be given after an interval of at least 4 weeks. Infants less than 6 months of age: the safety and efficacy of _Influvac Sub-unit Tetr Lire le document complet