Tetanus Antitoxin is indicated for providing short-term passive immunity for both the prevention and management of tetanus.

This is a sterile, clear solution of tetanus antitoxin (equine), appearing pale yellow to brown, intended for human use. It contains antitoxin globulins capable of specifically neutralizing the toxin produced by Clostridium tetani. The preparation is derived by fractionating the serum of horses that have been hyperimmunized against tetanus toxin.

Prophylaxis of tetanus: Tetanus Antitoxin (equine) is not recommended for routine management of traumatic wounds. It is indicated for individuals at risk of tetanus infection due to infected wounds or severe injuries. For post-injury prophylaxis, non-immunized or partially immunized individuals may receive 3,000–5,000 IU subcutaneously or intramuscularly. If more than 24 hours have passed since injury, the dose should be increased to 3,000 IU.

In cases of crush injuries or wounds contaminated with soil or foreign materials, the recommended dose is 10,000–20,000 IU. For individuals under 30 kg body weight, the dose is 1,500 IU. Active immunization with Adsorbed Tetanus Vaccine should be administered simultaneously or as a booster if the individual has previously been immunized.

Treatment: Therapy should begin as soon as symptoms appear. The minimum therapeutic dose is 3,000 IU. Depending on severity, hospitalized patients may require 50,000–100,000 IU, administered partly intravenously and the remainder intramuscularly.

Gently mix the solution before use; avoid vigorous shaking. Examine the solution visually for any particles or discoloration prior to administration. If any abnormalities are observed, the solution should not be used. It should be administered as supplied without dilution. Once the vial is opened, it must be used immediately.

Co-administration: Immunosuppressive therapy should be discontinued when immunization is necessary due to a tetanus-prone wound.

Use of this antitoxin is contraindicated in individuals with a known history of allergy to equine proteins or in those who are generally prone to allergic reactions.

Hypersensitivity reactions may occur following administration of serum derived from animal sources. In rare cases, hypotension, difficulty in breathing (dyspnea), and urticaria may develop. These reactions should be treated with adrenaline, and if necessary, antihistamines and corticosteroids. Serum sickness may appear 7 to 10 days after administration, with symptoms such as fever, vomiting, diarrhea, bronchospasm, and urticaria.

Tetanus Antitoxin (equine) should not be administered during pregnancy.

In individuals with no prior history of serum injection or allergic reactions, the full dose may be administered intramuscularly. For patients with a tendency to allergic reactions, a test dose of 0.2 ml (diluted 1:10) should be given subcutaneously. If no general reaction occurs within 30 minutes, the remaining dose may be administered intramuscularly. The patient should be observed for at least 30 minutes after injection, and adrenaline should be kept readily available for emergency use. In urgent situations, intravenous administration may be considered; however, it should only be used if a prior intramuscular test dose (given at least 30 minutes earlier) has been tolerated. For intravenous use, the serum should be at room temperature, injected slowly, and the patient should remain in a lying position during administration and for at least one hour afterward.

Not applicable.

Vaccines, Anti-sera & Immunoglobulin

Keep out of the sight and reach of children. Store between +2°C and +8°C. Transport should also be maintained within +2°C to +8°C. Do not freeze. If the solution becomes frozen, it must be discarded. Protect from light.