Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Influenza virus haemagglutinin type A/Vietnam/1194/2004 NIBRG-14 (H5N1) 3.75ug
GlaxoSmithKline NZ Limited
Influenza virus haemagglutinin type A/Vietnam/1194/2004 NIBRG-14 (H5N1) 3.75 µg
3.75 mcg
Suspension for injection
Active: Influenza virus haemagglutinin type A/Vietnam/1194/2004 NIBRG-14 (H5N1) 3.75ug Excipient: Dibasic sodium phosphate dodecahydrate Magnesium chloride Monobasic potassium phosphate Octoxinol Polysorbate 80 Potassium chloride Sodium chloride Thiomersal Water for injection D-alpha Tocoferol Dibasic sodium phosphate dodecahydrate Monobasic potassium phosphate Polysorbate 80 Potassium chloride Sodium chloride Squalene Water for injection
Vial, glass, Adjuvant, 0.225 mL
Prescription
Prescription
GlaxoSmithKline Biologicals (Dresden)
indicated for prophylaxis of influenza in an officially declared pandemic situation. The vaccine may only be marketed, or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.
Package - Contents - Shelf Life: Vial, glass, Adjuvant - 0.225ml per dose, 10 doses per vial - 250 dose units - 5 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Antigen - 0.25ml per dose, 10 doses per vial - 500 dose units - 5 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted (not refrigerated) stored at or below 25°C protect from light. combined with adjuvant
2008-12-24
1 NEW ZEALAND DATA SHEET PANDEMRIX ® PANDEMIC INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED, AS03 ADJUVANTED) NAME OF THE MEDICINE _PANDEMRIX_, emulsion and suspension for emulsion for injection. Pandemic influenza vaccine (split virion, inactivated, AS03 adjuvanted). DESCRIPTION The antigen composition will be determined depending on the strain for the pandemic influenza that will be recommended by the World Health Organisation (WHO). Each 0.5mL vaccine dose contains 3.75 micrograms 1 of antigen 2 of the recommended strain and is adjuvanted with AS03 3 . 1 haemagglutinin 2 propagated in eggs 3 The GlaxoSmithKline proprietary AS03 adjuvant system is composed of squalene (10.68 milligrams), DL- α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams) Each 0.5mL vaccine dose also contains the excipients Polysorbate 80, Octoxinol 10, Thiomersal, Sodium Chloride, Disodium hydrogen phosphate, Potassium dihydrogen phosphate, Potassium Chloride, Magnesium chloride, Alpha-tocopherol, Monobasic potassium phosphate, Squalene, Dibasic sodium phosphate dodecahydrate, Monobasic potassium phosphate, and water for injections. The vaccine may also contain the following residues: egg residues including ovalbumin, gentamicin sulfate, formaldehyde, sucrose and sodium deoxycholate. This medicine has been granted provisional consent under section 23 of the Medicines Act 1981. CLINICAL PHARMACOLOGY CLINICAL TRIALS This section describes the clinical experience with the mock-up vaccines following a two-dose administration. Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses. These antigens can be considered as “novel” antigens and simulate a situation where the target population for vaccination is immunologically naïve. Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical efficacy and safety data obtained with mock-up vaccines are relevant for the pandemic vaccines. 2 Lesen Sie das vollständige Dokument