AGRIPPAL S-1Influenza Vaccine
|A/Texas/36/91 (H1N1 )||15 microgram per 0,5 mL dose|
|A/Johannesburg/33/94 (H3N2)-like strain||15 microgram per 0,5 mL dose.|
|B/Harbin/07/94||15 microgram per 0,5 mL dose.|
|Preservative: Thimerosal||0,05 mg per 0,5 mL dose.|
Slightly cloudy colourless liquid in clear glass ampoule or pre-filled syringe.
PHARMACOLOGICAL ACTION OF THE MEDICINE:
For active immunisation against influenza.
For the prophylaxis of influenza in persons older than 6 months. Vaccination is recommended for individuals at high risk for the complications of influenza and in whom the complications may have serious consequences eg. patients with:
|||chronic respiratory cardio-vascular or renal conditions,|
|||diabetes mellitus and Addison's disease,|
|||elderly and debilitated persons (especially if hospitalised.)|
Influenza vaccine is contra-indicated in the following conditions:
|||Hypersensitivity to eggs, chicken or chicken feathers.|
|||Any febrile respiratory illness, or other active febrile infection.|
|||Individuals who are pregnant, or plan to become pregnant within 3 months following vaccination.|
|||Patients receiving therapy with ACTH, corticosteroids, irradiation, alkylating agents or antimetabolites. This contra-indication does not apply to patients receiving corticosteroids as replacement therapy at physiological doses e.g. for Addison's disease.|
DOSAGE AND DIRECTIONS FOR USE:
Shake well before using. Inject intramuscularly or deep subcutaneously.
DO NOT INJECT INTRAVENOUSLY.
From 6 - 35 months of age: 2 doses of 0,25 mL each, 4 weeks apart.
From 3 years old: 2 doses of 0,5 mL each, 4 weeks apart.
A single dose of 0,5 mL may be given if vaccinated against influenza in the previous 12 months.
Active immunisation with a single dose is recommended annually in high risk individuals.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Slight redness or swelling at the inoculation site, may occur. Systematic manifestations (e.g. malaise) may occur.
DO NOT INJECT INTRAVENOUSLY Measures to treat anaphylaxis including a syringe containing 1 mL adrenaline (1:1000) should be available when administering Agrippal S-1. Vaccination should be given with caution in individuals with a personal or family history of allergy.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
See "Side Effects and Special Precautions" Treatment is symptomatic and supportive.
|a) 1 x 0,5 mL clear glass ampoule||c) 1 x 0,5 mL prefilled syringe|
|b) 10 x 0,5 mL clear glass ampoules||d) 10 x 0,5 mL prefilled syringes.|
Store refrigerated at +2°C to +8°C. DO NOT FREEZE. Keep out of reach of children.
NAME AND ADDRESS OF APPLICANT:
Biovac S.A. c.c., 1 Manchester Road, Wadeville, South Africa.
DATE OF PUBLICATION OF PACKAGE INSERT: