Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Influenza virus split virion
split virion, inactivated) suspension for injection 0.5ml pre-filled syringes (Sanofi
J07BB02
Influenza virus split virion
Suspension for injection
Intramuscular; Subcutaneous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 14040000; GTIN: 5000283658962 5000283658979
PACKAGE LEAFLET: INFORMATION FOR THE USER QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED), SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Quadrivalent influenza vaccine (split virion, inactivated) 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 OR YOUR CHILD ARE VACCINATED 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. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET 1. What Quadrivalent Influenza Vaccine (split virion, inactivated) is and what it is used for 2. What you need to know before you or your child use Quadrivalent Influenza Vaccine (split virion, inactivated) 3. How to use Quadrivalent Influenza Vaccine (split virion, inactivated) 4. Possible side effects 5. How to store Quadrivalent Influenza Vaccine (split virion, inactivated) 6. Contents of the pack and other information 1. WHAT QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) IS AND WHAT IT IS USED FOR Quadrivalent Influenza Vaccine (split virion, inactivated) is a vaccine. This vaccine helps to protect you or your child against influenza (flu). The use of Quadrivalent Influenza Vaccine (split virion, inactivated) should be based on official recommendations. When a person is given Quadrivalent Influenza Vaccine (split virion, inactivated), 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 Læs hele dokumentet
OBJECT 1 QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) Summary of Product Characteristics Updated 10-Jan-2018 | Sanofi Pasteur 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 Quadrivalent Influenza Vaccine (split virion, inactivated), suspension for injection in pre-filled syringe Quadrivalent 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** 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 WHO recommendations (Northern Hemisphere) and EU decision for the 2017/2018 season. For the full list of excipients, see Section 6.1. Quadrivalent Influenza Vaccine (split virion, inactivated) 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 pre-filled syringe. The vaccine, after shaking gently, is a colourless opalescent liquid. 4. Clinical particulars 4.1 Therapeutic indications Quadrivalent Influenza Vaccine (split virion, ina Læs hele dokumentet