Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Cipla
INDICATIONS [/za_1103.html#1] [/za_1103.html#1] [/za_1103.html#1] CONTRA-INDICATIONS [/za_1103.html#1] [/za_1103.html#1] DOSAGE [/za_1103.html#1] [/za_1103.html#1] SIDE-EFFECTS [/za_1103.html#1] [/za_1103.html#1] [/za_1103.html#2] PREGNANCY [/za_1103.html#2] [/za_1103.html#1] OVERDOSE [/za_1103.html#1] IDENTIFICATION [/za_1103.html#1] [/za_1103.html#1] PATIENT INFORMATION FLUVIRIN® REGISTRATION NUMBER: 28/30.1/0711 PROPRIETARY NAME (and dosage form): FLUVIRIN ® DESCRIPTIVE NAME: Inactivated INFLUENZA VACCINE (Surface Antigen) PHARMACOLOGICAL CLASSIFICATION: A 30.1 Biological antigen SCHEDULING STATUS: S2 COMPOSITION: Each 0,5 mL dose contains inactivated influenza virus subunits: A/Texas/36/91 (H1N1) > 15 µg A/Johannesburg/33/91(H3N2) > 15 µg B/Harbin/07/94 > 15 µg Preservative: Thiomersal 0,01% m/v These are the strains currently recommended for South Africa in 1996. These strains may change for subsequent years. IDENTIFICATION: Slightly opalescent liquid free from extraneous particles. PHARMACOLOGICAL ACTION OF THE MEDICINE: After injection, increasing levels of the surface antigens in the circulation stimulate the production of immunoglobulins of the M and G type which first become detectable in the serum at about 5 - 7 days, rising to a maximum between 10 - 21 days. A rise of fourfold in the circulating levels of a specific antibody is taken as indicative of a successful (and thus protective) response. INDICATIONS: Prophylaxis against influenza in high risk groups, especially the elderly. Also recommended for patients with chronic cardiac disease, chronic pulmonary disease, chronic renal disease or diabetes and patients receiving immunosuppressive therapy. CONTRA-INDICATIONS: FLUVIRIN is contra-indicated in persons sensitive to egg, chicken or influenzal Read the complete document