AGRIPPAL S-1Influenza Vaccine

PROPRIETARY NAME
(and dosage form):

AGRIPPAL S-1

DESCRIPTIVE NAME OF MEDICINE:
Inactivated Sub-Unit Influenza Vaccine, Types A & B.

REGISTRATION NUMBER:
27/30.1/584

PHARMACOLOGICAL CLASSIFICATION:
A.30.1 Biologicals –Antigen

SCHEDULING STATUS:
S2

COMPOSITION:
Agrippal S-1 is a suspension containing highly purified surface antigens of Influenza Virus Types A and B propagated in chick embryo cell cultures and inactivated with Betapropiolactone. Each 0,5 mL dose contains inactivated influenza virus sub-units of the strains and in the concentrations currently recommended for South Africa by WHO and the National Health Authority for 1996.
These strains may change for subsequent years.

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.

IDENTIFICATION:
Slightly cloudy colourless liquid in clear glass ampoule or pre-filled syringe.

PHARMACOLOGICAL ACTION OF THE MEDICINE:
For active immunisation against influenza.

INDICATIONS:
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.)

CONTRA-INDICATIONS:
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.

PRESENTATION:

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.

 

STORAGE DIRECTIONS:
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:
November 1995

J/95 L12077

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