देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Influenza virus A/California/7/2009 (H1N1) - like strain 15ug
Seqirus (NZ) Ltd
Influenza virus A/California/7/2009 (H1N1) - like strain 15 µg
15 mcg/0.5mL
Suspension for injection
Active: Influenza virus A/California/7/2009 (H1N1) - like strain 15ug Excipient: Calcium chloride dihydrate Dibasic sodium phosphate Monobasic potassium phosphate Monobasic sodium phosphate dihydrate Potassium chloride Sodium chloride Thiomersal Water for injection
Syringe, glass, 0.5 mL, 1 pack, 0.5 mL
Prescription
Prescription
Seqirus Pty Ltd
For active immunisation to prevent influenza disease caused by the influenza A(H1N1) virus, in adults, adolescents and children 10 years of age and older.
Package - Contents - Shelf Life: Syringe, glass, 0.5 mL, 1 pack - 0.5 mL - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 0.5 mL, 10 pack - 5 mL - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, multi-dose, 5 mL, 10 pack - 50 mL - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2007-06-22
Panvax ® H1N1 Vaccine (TT50-7970) 5 mL and 10mL multi-dose vial and 0.5mL pre-filled single dose syringe presentations Data Sheet February 2010 Page 1 of 7 NAME OF THE MEDICINE Panvax ® H1N1 Vaccine H1N1 Pandemic influenza vaccine (split virion, inactivated). DESCRIPTION Panvax ® H1N1 Vaccine is a purified, inactivated, monovalent, split virion (split virus) vaccine. A single 0.5 mL dose contains antigen of the following type: A/California/7/2009 (H1N1) (NYMC X-179A) (A/California/7/2009 (H1N1)v-like) 15 µg haemagglutinin (HA) per dose Each 0.5 mL dose contains, nominally: sodium chloride 4.1 mg, sodium phosphate – dibasic anhydrous 0.3 mg, sodium phosphate – monobasic 0.08 mg, potassium chloride 0.02 mg, potassium phosphate – monobasic 0.02 mg, calcium chloride 1.5 μg and thiomersal 50 μg (for multi-dose vial presentation only). The following are present in each 0.5 mL dose: sodium taurodeoxycholate 5 μg, ovalbumin ≤ 1.0 μg, sucrose < 10 μg, neomycin 0.7 ng, polymyxin B sulfate 0.11 ng and beta-propiolactone 1.4 ng. The virus strain in this vaccine complies with the Australian Influenza Vaccine Committee (AIVC) decision, endorsing the World Health Organisation recommended virus for the influenza A(H1N1) vaccine. Panvax ® H1N1 Vaccine is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. The virus is harvested from the eggs, purified by zonal centrifugation, inactivated with beta-propiolactone and disrupted with sodium taurodeoxycholate to produce split virion particles. PHARMACOLOGY Immunisation with inactivated influenza vaccines has been shown to induce antibodies to the viral surface glycoproteins, haemagglutinin and neuraminidase. These antibodies are important in the prevention of natural infection. CLINICAL TRIALS Clinical trials are being conducted to assess the immunogeni पूरा दस्तावेज़ पढ़ें