Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
INFLUENZA VACCINE, SPLIT VIRION, INACTIVATED
Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France
J07BB02
INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) 15 µg
SUSPENSION FOR INJECTION
INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) 15 µg
POM
VACCINES
Withdrawn
2007-01-18
PACKAGE LEAFLET: INFORMATION FOR THE USER VAXIGRIP, 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 Vaxigrip is and what it is used for 2. What you need to know before you or your child use Vaxigrip 3. How to use Vaxigrip 4. Possible side effects 5. How to store Vaxigrip 6. Contents of the pack and other information 1. WHAT VAXIGRIP IS AND WHAT IT IS USED FOR Vaxigrip is a vaccine. This vaccine helps to protect you or your child against influenza (flu). The use of Vaxigrip should be based on official recommendations. When a person is given the vaccine Vaxigrip, 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 be vaccinated up until the spring since you or your child run the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated. Vaxigrip is intended to protect you or your child against the three strains of virus contained in the vaccine from about 2 to 3 weeks after the injection. The incubation period Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT VAXIGRIP, 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/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain (A/Singapore/INFIMH-16-0019/2016, IVR-186) ........................................................................................................... 15 micrograms HA** • B/Colorado/06/2017 - like strain (B/Maryland/15/2016, NYMC BX-69A) ..... 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 2018/2019 season. For the full list of excipients, see Section 6.1. VAXIGRIP 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. VAXIGRIP is indicated in adults and children from 6 months of age. The use of VAXIGRIP should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: 0.5 ml. _Paediatric population _ Children from 36 months onwards: 0.5 ml. Children from 6 months to 35 months: 0.25 ml. Clinical data are limited. See Section 6.6 for more information on administration of 0.25 ml dose. If this is required by national recommendations, 0.5 ml may be given. For children less than 9 years who have not previously bee Lue koko asiakirja