A Bacterial Cholera Prophylactic Vaccine
T537 (Act 101/1965)
A suspension in a phosphate buffered saline solution of equal parts of cholera vibrios of serotypes INABA and OGAWA to give 8000 million per 1 mL dose with 0,05% phenol as preservative.
A pale milky translucent suspension with a slight odour due to the preservative.
Induces in the recipient a specific immunity to cholera.
For active immunisation against cholera.
Not recommended for patients with an acute infections or for children less than one year old. Should be used with great caution if there has been a history of allergy to previous vaccination.
DOSAGE AND DIRECTIONS FOR USE:
For primary immunisation of adults or children of 14 years or older, two (2) doses of 1 mL are given by subcutaneous injection 14 days apart. It may be expected to confer immunity in about 50% of subjects for up to six months, but persons at risk should be aware of the importance of good hygiene and safe drinking water in the prevention of cholera. The dose for children over 1 year old should be between 0,1 mL and 1 mL in proportion to body mass. Further doses may be given at 6 monthly intervals if required. Not recommended for children less than 1 year old. Sterilise the rubber closure with tincture of iodine and shake vial vigorously before use.
N.B. The immunogenic activity of Cholera is reduced if given within three weeks of a yellow fever injection.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Enquiry regarding previous hypersensitivity should precede the administration of a vaccine, and measures to treat reactions should be immediately available. Anaphylactic reactions, which are rare, should be treated with adrenaline, possibly in association with antihistamine and corticosteroid therapy.
Reactions following administration may include anorexia, fever, vomiting, and malaise. May cause transient local and general reactions for which symptomatic treatment should be given. Neurological or psychiatric reactions have occasionally occurred as have the occasional slight swelling, erythema and tenderness at the injection site.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No known symptoms
Multidose 10 mL vials (10 doses) packed singly.
Multidose 10 mL vials packed 10 x 10 mL.
Store at 2° C to 10° C. DO NOT FREEZE. Protect from light.
NAME AND BUSINESS ADDRESS OF APPLICANT:
The South African Institute for Medical Research.
Rietfontein, Edenvale, Transvaal.
P.O. Box 28999, Sandringham, 2131
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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