Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: 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
prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Vaccines
Influenza, Human; Immunization; Disease Outbreaks
Active immunisation against H5N1 subtype of Influenza A virus.This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1).Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.
Revision: 3
Withdrawn
2008-09-26
25 B. PACKAGE LEAFLET Medicinal product no longer authorised 26 PACKAGE LEAFLET: INFORMATION FOR THE USER PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 ΜG SUSPENSION AND EMULSION FOR EMULSION FOR INJECTION Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS VACCINE. - 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. Do not pass it on to others. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for 2. Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg 3. How Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is given 4. Possible side effects 5. How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg 6. Further information 1. WHAT PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 ΜG IS AND WHAT IT IS USED FOR Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is a vaccine for use in adults from 18 years old. It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus. Pandemic flu is a type of influenza that occurs at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The symptoms of pandemic flu are similar to those of ordinary flu but are usually m Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection. Prepandemic 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 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. Excipients: It contains 5 micrograms thiomersal For a 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 homogeneous liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation against H5N1 subtype of Influenza A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1). Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. Medicinal product no longer authorised 3 Based on very limited data, adults aged >80 years may require a double dose of Prepandemic influenza vaccine (H5N1) (split virion, inactiva Izlasiet visu dokumentu