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Logo TETANUS ANTITOXIN

TETANUS ANTITOXIN
Tet/Ser
PROPRIETARY NAME:
TETANUS ANTITOXIN

DESCRIPTIVE NAME:
Tetanus Immunoglobulin (Equine)

REGISTRATION NUMBER:
T511/2/3/4 (1500, 5000, 10 000 & 20 000 units).

PHARMACOLOGICAL CLASSIFICATION:
A30.2 Antibodies.

SCHEDULING STATUS:
S4

COMPOSITION:
Tetanus Antitoxin 1 500 u/mL, Cresol 0,3% as preservative.
Tetanus Antitoxin 4 000 u/mL, Cresol 0,3% as preservative.

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

PHARMACOLOGICAL ACTION:
Neutralises the toxin produced by Clostridium tetani. The toxin has a high affinity for nerve tissue and antitoxin is unlikely to have an effect on toxin that is no longer circulating.

INDICATIONS:
Used to provide temporary passive immunity in the prevention and treatment of tetanus.

CONTRA-INDICATIONS:
This preparation of Tetanus Antitoxin (equine) should not be used if Human Antitetanus Immunoglobulin inj. is available. Should be used with great caution if patient is subject to allergic disease such as asthma or infantile eczema, or was allergic to any previous antiserum injection.

DOSAGE AND DIRECTIONS FOR USE:
Prophylactic use:
Tetanus Antitoxin (equine) should not be used in the routine treatment of traumatic wounds. If the wound is extensive, with a high risk of tetanus infection, antitoxin, (preferably the human immunoglobulin) may be injected intramuscularly at the earliest possible moment after infliction of the injury. If equine antitoxin is used, the dose is usually from 1500 to 6000 units.

Active immunisation with Adsorbed Tetanus Vaccine should begin simultaneously with the use of this preparation or a booster injection of Tetanus Vaccine should be given if the patient has previously been immunised. The vaccine should be injected at a different site to that used for the antitoxin. Antitoxin should never be used if a booster dose of Tetanus vaccine would suffice.

IT MUST BE KEPT IN MIND THAT THE DANGER OF TETANUS IS NEVER PAST UNTIL THE WOUND HAS THOROUGHLY BEEN CLEANED AND EVERY PARTICLE OF FOREIGN BODY HAS BEEN REMOVED FROM THE INJURED SITE.

Therapeutic use:
The full and adequate dose, possibly of the order of 100,000 units depending on the severity of the symptoms, should be given as soon as tetanus is suspected; at least some of the antitoxin should 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 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 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 during an interval of 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 :
1500 u in 1 mL; 5000 u in 1.25 mL; 10 000 u in 2.5 mL; 20 000 u in 5 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

141-794

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