Land: Europeiska unionen
Språk: engelska
Källa: 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, Immunization, Disease Outbreaks
Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.,
Revision: 9
Authorised
2009-10-09
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 pandem Läs hela dokumentet
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 pandem Läs hela dokumentet