Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
GlaxoSmithKline Biologicals S.A.
J07BB02
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Vaccines
Influenza, Human
Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.
Authorised
2009-10-10
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE USER ADJUPANRIX SUSPENSION AND EMULSION FOR EMULSION FOR INJECTION Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS VACCINE 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 or nurse. • This vaccine has been prescribed for you only. Do not pass it on to others. • If you get any side effects, talk to your doctor.This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Adjupanrix is and what it is used for 2. What you need to know before you receive Adjupanrix 3. How Adjupanrix is given 4. Possible side effects 5. How to store Adjupanrix 6. Contents of the pack and otherinformation 1. WHAT ADJUPANRIX IS AND WHAT IT IS USED FOR WHAT ADJUPANRIX IS AND WHAT IT IS USED FOR Adjupanrix is a vaccine for use in adults from 18 years old to prevent pandemic flu (influenza). 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 ADJUPANRIX WORKS When a person is given the vaccine, the body’s natural defence system (immune system) produces its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu. As with all vaccines, Adjupanrix may not fully protect all persons who are vaccinated. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ADJUPANRIX ADJUPANRIX SHOULD NOT BE GIVEN • If you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts, such as: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate. _ Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Adjupanrix suspension and emulsion for emulsion for injection. Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains: Split influenza virus, inactivated, containing antigen * equivalent to: _ _ A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14) 3.75 micrograms ** * propagated in eggs ** haemagglutinin This vaccine complies with the WHO recommendation and EU decision for the pandemic. AS03 adjuvant composed of squalene (10.69 milligrams), DL- α -tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams) The suspension and emulsion vials once mixed form a multidose container. See section 6.5 for the number of doses per vial. Excipient with known effect: The vaccine contains 5 micrograms thiomersal (see section 4.4). For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Suspension and emulsion for emulsion for injection. The suspension is a colourless light opalescent liquid. The emulsion is a whitish to yellowish homogeneous milky liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza in an officially declared pandemic situation. Adjupanrix should be used in accordance with official guidance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Persons not previously vaccinated with Prepandrix Adults from the age of 18 years: One dose of 0.5 ml at an elected date. A second dose of 0.5 ml should be given after an interval of at least three weeks and up to twelve months after the first dose for maximum efficacy. 3 Based on very limited data, adults aged >80 years may require a double dose of Adjupanrix on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1). Persons previously vaccinated with one or two doses of Prepandrix containing HA derived from a different clade of the same influenza subtype as the pande Прочитать полный документ