H1N1 Influenza A Vaccine Antigen (Split Virion), Inactivated

Specification

• Cat#: VZV-423
• Product Name: H1N1 Influenza A Vaccine Antigen (Split Virion), Inactivated
• Species: Influenza A virus
• Formulation: The active ingredient is the influenza A(H1N1) virus hemagglutinin antigen, and the excipients are NaCl, Na2HPO4 and NaH2PO4. The thimerosal is added as preservative.
• Storage: Store and ship strictly at 2-8°C away from light and prevent freezing.
• Stability: 12 months
• Usage: One dose for each person. Inject i. m. the vaccine in the deltoid muscle of the lateral upper arm.
• Product Overview: H1N1 Influenza A Vaccine(Split Virion), Inactivated made from the influenza A(H1N1) virus strain(2009) recommended by WHO. The strain is grown in embryonated eggs. After cultivation, the virus-containing allantoic fluid is harvested and inactivated with formaldehyde. The virus is then concentrated, purified and chemically disrupted to produce a split vaccine.
• Application: The product can induce immunity against influenza A(H1N1) virus in recipients following immunization. It is used to prevent influenza caused by this type of virus.
• Adverse Reactions: Based on the completed summary analysis of the 10 domestic clinical trials' results (see [Clinical Trials]), the overall adverse reaction incidence is 17.40% in vaccine group (15μɡ+30μɡ, similarly hereinafter) and 10.98% in placebo group. The most common adverse reactions are pyrexia, soreness at the vaccination site, headache and fatigue; occasionally cough, diarrhea, myalgia, local pruritus, nausea and vomiting, local redness, swelling and induration, urticaria, maculopapule and rash (injection site); and others like dizziness, sore throat, stomachache and arthralgia. Adverse reactions mostly began from day 0 to day 3. The adverse reaction incidence was 16.67% in vaccine group and 9.85% in placebo group.Vaccination against H1N1 Influenza A Vaccine (Split Virion), Inactivated may also occur infrequent adverse reactions, such as: shock, vasculitis-like transient renal involvement, nervous system diseases as encephalomyelitis, neuritis, neuralgia, paresthesia, convulsions, transient thrombocytopenia, Guillain-Barré Syndrome, etc. Although there is none of the above reactions occurred in the clinical trails of the H1N1 Influenza A Vaccine (Split Virion), Inactivated, observation should be taken during vaccination.Report any adverse reaction unmentioned above to the healthcare providers immediately.
• Package: 0.5 mL per container. 0.5 mL per single human dose containing 15 μg of hemagglutinin of influenza A (H1N1) virus.
• Appearance: Slightly opalescent liquid.