Land: Singapore
Taal: Engels
Bron: HSA (Health Sciences Authority)
PURIFIED ANTIGEN FRACTIONS OF INACTIVATED SPLIT VIRIONS - A/INDONESIA/05/2005 (H5N1)/PR8-IBCDC-RG2
GLAXOSMITHKLINE PTE LTD
J07BB02
3.75 µg haemagglutinin/0.25 ml
INJECTION, EMULSION
PURIFIED ANTIGEN FRACTIONS OF INACTIVATED SPLIT VIRIONS - A/INDONESIA/05/2005 (H5N1)/PR8-IBCDC-RG2 3.75 µg haemagglutinin/0.25 ml
INTRAMUSCULAR
Prescription Only
GlaxoSmithKline Biologicals (previously known as Sachsisches Serumwerk Dresden) (for H5N1)
ACTIVE
2009-03-24
1 PREPANDRIX™ PREPANDEMIC INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED, AS03 ADJUVANTED) QUALITATIVE AND QUANTITATIVE COMPOSITION PREPANDRIX™ is an inactivated influenza vaccine (split virion) of a strain with pandemic potential containing antigen (propagated in embryonated eggs) equivalent to A/Indonesia/05/2005 PR8-IBCDC-RG2 (H5N1) adjuvanted with AS03 composed of squalene (10.69 milligrams), DL- α -tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams). Each 0.5 ml vaccine dose contains 3.75 µg haemagglutinin of the recommended strain and is adjuvanted with AS03. Excipients: It contains 5 micrograms thiomersal. PHARMACEUTICAL FORM Suspension and emulsion for emulsion for injection. CLINICAL PARTICULARS 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/Indonesia/05/2005 PR8-IBCDC-RG2 (H5N1). PREPANDRIX™ should be used in accordance with official recommendations. DOSAGE AND ADMINISTRATION Adults from the age of 18 years onwards will receive two doses of PREPANDRIX™, the first administered at an elected date, the second at least three weeks after the first dose for maximum efficacy. The experience in children is limited (see Adverse Reactions and Pharmacodynamic Effects). Vaccination should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass). 2 CONTRAINDICATIONS History of an anaphylactic reaction (i.e. life-threatening) to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine. Acute severe febrile illness. Immunisation should be postponed. WARNINGS AND PRECAUTIONS C Lees het volledige document
1 PREPANDRIX™ PREPANDEMIC INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED, AS03 ADJUVANTED) QUALITATIVE AND QUANTITATIVE COMPOSITION PREPANDRIX™ is an inactivated influenza vaccine (split virion) of a strain with pandemic potential containing antigen (propagated in embryonated eggs) equivalent to A/Indonesia/05/2005 PR8-IBCDC-RG2 (H5N1) adjuvanted with AS03 composed of squalene (10.69 milligrams), DL- α -tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams). Each 0.5 ml vaccine dose contains 3.75 µg haemagglutinin of the recommended strain and is adjuvanted with AS03. Excipients: It contains 5 micrograms thiomersal. PHARMACEUTICAL FORM Suspension and emulsion for emulsion for injection. CLINICAL PARTICULARS 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/Indonesia/05/2005 PR8-IBCDC-RG2 (H5N1). PREPANDRIX™ should be used in accordance with official recommendations. DOSAGE AND ADMINISTRATION Adults from the age of 18 years onwards will receive two doses of PREPANDRIX™ , the first administered at an elected date, the second at least three weeks and up to twelve months after the first dose for maximum efficacy. The experience in children is limited (see _Adverse Reactions_ and _Pharmacodynamic _ _Effects_ ). Vaccination should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass). 2 CONTRAINDICATIONS History of an anaphylactic reaction (i.e. life-threatening) to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine. Acute severe febrile illness. Immunisation should be postponed. WARNINGS AND PRECAUTIONS Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to th Lees het volledige document