INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo AGRIPPAL™ S1

L12077 - 12/02

PROPRIETARY NAME
(and dosage form):

AGRIPPAL™ S1
SEASON 2003

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 S1 is an influenza vaccine containing the surface antigens of influenza myxoviruses, strains A and B, propagated in embryonated chicken eggs and inactivated with Formaldehyde.
Each 0.5 mL dose contains inactivated influenza virus of the strains and in the concentrations currently recommended for South Africa by WHO and the National Health Authority for 2003.
These strains may change for subsequent years.
Each 0.5 mL contains:
A/New Caledonia/20/99 (H1N1) - like strain (A/New Caledonia/20/99 IVR-116) 15 micrograms HA*
A/Moscow/10/99 (H3N2) - like strain (A/Panama/2007/99 RESVIR 17) 15 micrograms HA*
B/Hong Kong/330/2001 - like strain (B/Shangdong/7/97) 15 micrograms HA*.
* viral haemagglutinin
Excipients: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride, calcium chloride, water for injections.

IDENTIFICATION:
Clear colourless liquid in a 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 e.g. patients with:
- chronic respiratory, cardio-vascular or renal conditions,
- elderly and debilitated persons (especially if hospitalised).

CONTRA-INDICATIONS:
Influenza vaccine is contra-indicated in the following conditions:
- Hypersensitivity to eggs, to chicken proteins and any other constituent of the vaccine.
- Immunisation must be postponed in patients with any febrile respiratory illness, or other active febrile infection.

DOSAGE AND DIRECTIONS FOR USE:
Shake well and allow to reach room temperature before using. Inject intramuscularly or deep subcutaneously.
DO NOT INJECT INTRAVENOUSLY.
From 6-35 months of age: 1 dose of 0.25 mL. For children who have not been previously infected or vaccinated a second dose should be given after an interval of at least 4 weeks.
Adults and children from 36 months of age: 1 dose of 0.5 mL.
Active immunisation is recommended annually in high-risk individuals.
If half a dose (0.25 mL) is to be administered, discard half the contained volume (up to the mark indicated on the syringe barrel), before injection.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Local reactions such as redness, swelling, pain, bruises and induration at the inoculation site, may occur. Systematic manifestations such as fever, malaise, shivering, fatigue, headache, sweating, myalgia and arthralgia may occur. These undesired reactions usually disappear within 1-2 days without treatment. The following effects were less frequently observed, neuralgia, paeresthesia, convulsions and transient thrombocytopenia. Allergic reactions have been reported in rare cases leading to shock. Vasculitis with transient renal involvement has been reported in very rare cases. Rarely, neurological disorders such as encephalomyelitis, neuritis and Guillain Barré syndrome have been reported. These side-effects are generally transient. When they appear it is advisable to consult a physician. It is important to inform the doctor if any side-effects which are not described on the leaflet appear.
Special precautions: The doctor should be informed about any known allergies and particular adverse reactions experienced after previous administration of any type of vaccine. DO NOT INJECT INTRAVENOUSLY. Measures to treat anaphylaxis including a syringe containing 1 mL adrenaline (1:1000) should be available when administering Agrippal S1. Vaccination should be given with caution in individuals with a personal or family history of allergy.

INTERACTIONS: Agrippal S1 can be administered simultaneously with other vaccines. Immunisation should be carried out on different limbs. Simultaneous administration may increase the risk of side-effects.
Following influenza vaccination, false positive results in serology testing using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1, have been observed. The Western Blot technique permits identification of false results. The transient false positive reactions could be due to the IgM response to the vaccine.

PREGNANCY AND LACTATION: In pregnant high-risk patients, the possible risks of infection should be weighed against the possible risks of vaccination. Aggripal S1 may be used during lactation.

WARNINGS:
Patients undergoing immunodepressive therapy and in patients with endogenous immunodeficiency may have a lower response to the vaccination than the one normally expected. The following substances are used during the manufacturing process and therefore- trace amounts may be present in the final vaccine: antibiotics (kanamycin and neomycin) and formaldehyde.
This vaccine contains thiomersal (in trace amounts) and therefore it is possible that the vaccinated subjects may experience a sensitisation reaction.

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 pre-filled syringe packed in a blister.
b) 10 x 0.5 mL pre-filled syringes packed in two blisters of 5 syringes each.

STORAGE DIRECTIONS:
Store at +2°C to +8°C. Protect from light. Do not remove from blister until ready to use. DO NOT FREEZE. Keep out of reach of children.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Biovac S.A. (Pty)Ltd
1 Manchester Road,
Wadeville
South Africa

MANUFACTURER Chiron S.p.a. via Fiorentina 1, 53100 Siena (Italy)

DATE OF PUBLICATION OF PACKAGE INSERT:
December 2002

L12077 - 12/02       
RISUF020(1202A)

Updated on this site: March 2003
Source: Pharmaceutical Industry

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