Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Influenza virus split virion
split virion, inactivated
J07BB01
Influenza virus split virion
Suspension for injection
Subcutaneous; Intramuscular
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 14040000; GTIN: 5015973611011 5015973671107
PACKAGE LEAFLET: INFORMATION FOR THE USER INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE. Influenza vaccine (split virion, inactivated) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVE THIS VACCINE 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 or pharmacist. - This vaccine has been prescribed for you or your child only. Do not pass it on to others. - If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET 1. What INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP is and what it is used for 2. What you need to know before you or your child use INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP 3. How to use INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP 4. Possible side effects 5. How to store INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP 6. Contents of the pack and other information 1. WHAT INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP IS AND WHAT IT IS USED FOR INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP is a vaccine. This vaccine helps to protect you or your child against influenza (flu). The use of INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP should be based on official recommendations. When a person is given the vaccine INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP, 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 sensibl Lire le document complet
OBJECT 1 INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP Summary of Product Characteristics Updated 20-Apr-2018 | Sanofi Pasteur 1. Name of the medicinal product INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP, suspension for injection in prefilled syringe. Influenza vaccine (split virion, inactivated). 2. Qualitative and quantitative composition Influenza virus (inactivated, split) of the following strains*: • A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275) ............................................................................................................................15 micrograms HA** • A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) ............................................................................................................................15 micrograms HA** • B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, 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 WHO recommendations (Northern Hemisphere) and EU decision for the 2017/2018 season. For the full list of excipients, see Section 6.1. INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP may contain traces of eggs, such as ovalbumin, and of neomycin, formaldehyde and octoxinol- 9, which are used during the manufacturing process (see Section 4.3). 3. Pharmaceutical form Suspension for injection in prefilled syringe. The vaccine, after shaking gently, is a slightly whitish and opalescent liquid. 4. Clinical particulars 4.1 Therapeutic indications Prophylaxis of influenza. INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP is indicated in adults and children from 6 months of age. The use of INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP should be based on official recommendations. 4.2 Posology and method of administration Posology Adults: Lire le document complet