This is a sterile clear, faintly yellow or brown liquid of tetanus antitoxin (equine) for human use. It is a preparation containing antitoxic globulins that have the power of specifically neutralizing the toxin formed by Clostridium tetani. It is obtained by fractionation from the serum of horses that have been hyperimmunized against tetanus toxin.

To provide temporary passive immunity in the prevention and treatment of tetanus.

Prophylaxis of tetanus: Tetanus Antitoxin (equine) should not be used in the routine treatment of traumatic wounds. It is given prophylactically to persons at the risk of tetanus infection by infected wounds or severe wounds. For prophylaxis after injury, non-immune or partially immune persons may be given 3,000 to 5,000 units of tetanus antitoxin subcutaneously or intramuscularly. If 24 hours have passed since the wound occurred, the dose is 3,000 III. In crush wounds or wounds contaminated with soil or other foreign bodies, the dose is 10,000 to 20,000 III. For persons below 30 kg the dosage is 1,500 IU. Active immunization with Adsorbed Tetanus vaccine should be given simultaneously with the use of this preparation or a booster injection of Adsorbed Tetanus vaccine should be given if the patient has previously been immunized.

Treatment: Therapy should be given as soon as possible after the appearance of symptoms of the disease. Therapeutic dose not less than 3000 IU. Depending on the severity, the dose may vary from 50,000 to 100,000 IU of tetanus antitoxin for hospitalized patients given partially by intravenous route and the rest of the dose intramuscularly.

Administration

The solution should be shaken well before use. Please do not shake vigorously. The solution should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exists, the solution should not be administered. The solution should be used as supplied; no dilution is necessary. Once the vial is opened, the preperation must be used immediately.

Co-administration: Immunosuppressive therapy should be interrupted when immunization is required because of a tetanus-prone wound.

Injection of the antitoxin to persons with a history of allergic reactions to equine protein and to allergic individuals is contraindicated.

Hypersensitive reactions may occur after the injection of any serum of animal origin. In rare cases hypotension, dyspnoea, urticaria may occur. It 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.

Overdose Effects

Not applicable.

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.

Pregnancy & Lactation

Tetanus antitoxin (equine) must not be administered during pregnancy.