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Logo DIPHTHERIA ANTITOXIN

DIPHTHERIA ANTITOXIN
Dip/Ser

PROPRIETARY NAME:
DIPHTHERIA ANTITOXIN

DESCRIPTIVE NAME:
Diphtheria Immunoglobulin (equine)

REGISTRATION NUMBER:
T506/7/8/9 (4000, 10 000, 20 000 and 40 000 units)

PHARMACOLOGICAL CLASSIFICATION:
A30.2 Antibodies

SCHEDULING STATUS:
S4

COMPOSITION:
Diphtheria Antitoxin 4 000 u/mL; Cresol 0,3% as Preservative.

IDENTIFICATION:
Clear, almost colourless or faintly yellow liquid, having a slight odour due to the preservative.

PHARMACOLOGICAL ACTION:
Neutralises the toxin produced by Corynebacterium diphtheriae locally at the site of infection and in the circulation, but does not affect the pathological changes already induced by the toxin

INDICATIONS:
Used for treatment of Diphtheria. Prophylactic use in persons exposed to infections is not recommended, as it is preferable to administer a suitable antibiotic and to observe the patient closely for up to 14 days. If there is any evidence of the development of diphtheria, the antitoxin should be given. If there is a positive history of active immunisation, a booster dose of Adsorbed Diphtheria Vaccine should be given to contacts; if not, active immunisation should be completed with two further doses of vaccine at intervals of a month.

CONTRA-INDICATIONS:
Should be used with great caution, if patient is subject to allergic diseases such as asthma or infantile eczema, or was allergic to any previous antiserum injection.

DOSAGE AND DIRECTIONS FOR USE:
Diphtheria is usually treated by the concomitant administration of antibiotics such as erythromycin or penicillin.
When the attack is mild or of moderate severity, doses of 4 000 u to 30 000 u of diphtheria antitoxin may be given intramuscularly, after a test dose to eliminate hypersensitivity; doses of 40 000 u to 100 000 u or even more may be given in severe cases. Doses of more than 40 000 u may be given intravenously.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Reactions are liable to occur after the injection of any serum of animal origin. Anaphylaxis may occur in some rare cases, with hypotension, dyspnoea, urticaria, and shock. Anaphylactic reactions should be treated with adrenalin, possibly in association with antihistamine and corticosteroid therapy.

Serum sickness may occur 7 to 10 days after injection of serum of animal origin; symptoms include fever, vomiting, diarrhoea, bronchospasm, and urticaria. Nephritis, myocarditis, neuritis, polyarthritis, and uveitis have been reported as rare complications of serum sickness.

If there is no history of previous serum injection or of allergic reaction, the dose of serum may be given intramuscularly. If the patient is subject to allergic diseases, a trial dose of 0,2 mL (diluted 1:10 if preferred) of the serum should be given subcutaneously; if no general reaction develops within 30 minutes, the main dose may be given intramuscularly. The patient must be kept under observation for at least 30 minutes after the injection and adrenaline kept in readiness for emergency use. In all urgent cases, the intravenous route is indicated, but should never be used unless a preliminary intramuscular injection, given at least 30 minutes beforehand, has been tolerated. For intravenous use, the serum should be at room temperature, the injection should be given very slowly, and the patient should be recumbent during the injection, and for at least an hour afterwards.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
None known.

PRESENTATION:
Ampoules packed singly containing 4 000 u in 1 mL; 10 000 u in 2,5 mL; 20 000 u in 5 mL; 40 000 u in 10 mL.

STORAGE INSTRUCTIONS:
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:
June 1990

136-493

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