País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275); A/hong kong/4801/2014 (h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b); B/brisbane/60/2008 - like strain (b/brisbane/60/2008)
Sanofi Pasteur
J07BB; J07BB02
A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275); A/hong kong/4801/2014 (h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b); B/brisbane/60/2008 - like strain (b/brisbane/60/2008)
15/15/15mc percent volume/volume
Suspension for injection
Product subject to prescription which may not be renewed (A)
Influenza vaccines; influenza, inactivated, split virus or surface antigen
Marketed
1998-05-01
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 administered to you or your child from 6 months of age helps to protect you or your child against influenza (flu). 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. When given during pregnancy the vaccine helps to protect the pregnant women but also helps to protect her baby from birth to less than 6 months of age through the transmission of protection from mother to baby during pregnancy (see also Sections 2 and 3). None of the ingredients in the vaccine can cause flu. The use of INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP should be based on official recommendations. Flu is a disease that can spread rapidly and Llegiu el document complet
Health Products Regulatory Authority 24 May 2019 CRN008JTP Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS ▼ 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 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/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. 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 for the prevention of Llegiu el document complet