Country: Եվրոպական Միություն
language: անգլերեն
source: EMA (European Medicines Agency)
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain
AstraZeneca AB
J07BB03
pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Vaccines
Influenza, Human
Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.Pandemic influenza vaccine H5N1 AstraZeneca should be used in accordance with official guidance
Revision: 9
Authorised
2016-05-20
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER PANDEMIC INFLUENZA VACCINE H5N1 ASTRAZENECA, NASAL SPRAY SUSPENSION Pandemic influenza vaccine (H5N1) (live attenuated, nasal) 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 THE VACCINE IS GIVEN 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, nurse or pharmacist. - This vaccine has been prescribed for you or your child only. Do not pass it on to others. - If any of the side effects gets serious, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Pandemic influenza vaccine H5N1 AstraZeneca is and what it is used for 2. What you need to know before you are given Pandemic influenza vaccine H5N1 AstraZeneca 3. How Pandemic influenza vaccine H5N1 AstraZeneca is given 4. Possible side effects 5. How to store Pandemic influenza vaccine H5N1 AstraZeneca 6. Contents of the pack and other information 1. WHAT PANDEMIC INFLUENZA VACCINE H5N1 ASTRAZENECA IS AND WHAT IT IS USED FOR Pandemic influenza vaccine H5N1 AstraZeneca is a vaccine to prevent influenza (flu) in an officially declared pandemic. It is used in children and adolescents 12 months to less than 18 years of age. Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The signs of pandemic flu are similar to those of ordinary flu but may be more serious. HOW PANDEMIC INFLUENZA VACCINE H5N1 ASTRAZENECA WORKS Pandemic influenza vaccine H5N1 AstraZeneca is similar to Fluenz Tetra (a nasal influenza vaccine containing four strains), except Pandemic influenza vaccin read_full_document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension Pandemic influenza vaccine (H5N1) (live attenuated, nasal) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.2 ml) contains: Reassortant influenza virus* (live attenuated) of the following strain**: A/Vietnam/1203/2004 (H5N1) strain (A/Vietnam/1203/2004, MEDI 0141000136) 10 7.0±0.5 FFU*** * propagated in fertilised hens’ eggs from healthy chicken flocks. ** produced in VERO cells by reverse genetic technology. This product contains a genetically modified organism (GMO). *** fluorescent focus units This vaccine complies with the WHO recommendation and EU decision for the pandemic. The vaccine may contain residues of the following substances: egg proteins (e.g. ovalbumin) and gentamicin. The maximum amount of ovalbumin is less than 0.024 micrograms per 0.2 ml dose (0.12 micrograms per ml). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, suspension The suspension is colourless to pale yellow, clear to opalescent with a pH of approximately 7.2. Small white particles may be present. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age. Pandemic influenza vaccine H5N1 AstraZeneca should be used in accordance with official guidance. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Children and adolescents from 12 months to less than 18 years of age_ 0.2 ml (administered as 0.1 ml per nostril). Two doses are recommended for all children and adolescents. The second dose should be administered after an interval of at least 4 weeks. _Childre read_full_document