PHARMACOLOGICAL CLASSIFICATION: A 30.1 Biological Antigens
SCHEDULING STATUS: S2
COMPOSITION: Each 0,5 mL contains Yellow Fever Virus 104.1 pfu.
IDENTIFICATION: White, cream or light brown freeze dried cake, free from extraneous matter.
PHARMACOLOGICAL ACTION: The live vaccine simulates mild natural infection. It stimulates B- and T-lymphocytes and sensitises them to respond to re-exposure or re-vaccination. Usually only a single dose is required.
INDICATIONS: For active immunisation against yellow fever in endemic areas. Yellow fever endemic areas are limited to the African and South American continents and Central America.
For active immunisation of travellers to and from such areas.
CONTRA-INDICATIONS: It is advisable to avoid vaccination during an acute infection. Since the vaccine is prepared in chick embryos and contains small quantities of neomycin and polymyxin, it should not be administered to individuals who are hypersensitive to egg or chick protein or to these antibiotics.
The vaccine should not be given to patients receiving high-dose systemic corticosteroid therapy; to patients receiving immunosuppressive therapy including general irradiation; to patients suffering from certain malignant conditions such as lymphoria, leukaemia or other tumors of the reticuloendothelial system.
Because of theoretical risk to the foetus, live vaccines should not be administered during preganancy unless it is considered there is a significant risk of exposure to infection.
The vaccine should not be given to either symptomatic or asymptomatic HIV positive individuals since there is insufficient evidence as to the safety of its use.
DOSAGE AND DIRECTIONS FOR USE: Before injection, any alcohol or disinfectant used for cleaning of the skin should be allowed to evaporate.
0,5 mL of reconstituted vaccine, given subcutaneously. The dose is the same for persons of all ages.
Not recommended for children under 9 months of age.
Reconstitution: Reconstitute the single dose with 0,7 mL diluent and the 5 dose with 3,5 mL diluent. Use only the sterile diluent supplied. Using a sterile syringe and needle inject the contents of the appropriate yellow fever vaccine diluent container into the vaccine vial and shake gently to ensure reconstitution.
Discard any unused portion within 1 hour of reconstitution.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Injection of the vaccine may be followed by a local reaction, possible with inflammation and lymphangitis. At the site of the injection an induration or sterile abscess may develop. The administration of a vaccine may be followed by fever, headache and malaise starting a few hours after injection and lasting for 1 or 2 days. Hypersensitivity reactions may occur and anaphylaxis has been reported.
Encephalitis has followed vaccination, generally in infants under 9 months of age. Therefore yellow fever vaccine is not usually given to infants under 9 months.
Precautions: Measures to treat anaphylaxis, including adrenalin, should be immediately available.
Live vaccines should either be administered simultaneously (but at different sites) or an interval of at least 3 weeks allowed between administration.
Also an interval of 3 months should be allowed between the use of live vaccines and the prior administration of immunoglobulins. If immunoglobulins are given after administration of a live vaccine an interval of at least 3 weeks should be allowed to elapse.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: "See side-effects and special precautions". Treatment is symptomatic and supportive.
PRESENTATION: 5 x 1 dose vaccine vials with 5 ampoules of diluent.
5 x 5 dose vaccine vials with 5 vials of diluent.
Stored between 2 - 8°C and protected from light.
Does not freeze, store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT: Medpro Pharmaceutica (Pty) Ltd
Unit 9 Rosen Heights
DATE OF PUBLICATION OF THIS PACKAGE INSERT: November 1995