Tetanus antitoxin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TETANUS ANTITOXIN

Composition:

Active substance: fragments of antitetanus immunoglobulin (equine);

1 ml of solution contains not less than 1000 IU of antitetanus immunoglobulin fragments (equine);

Excipients: cresol (0.25%), glycine (22.5 mg/ml), sodium chloride, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear solution ranging in color from pale yellow to light brown. Slight opalescence or a small amount of solid particles may occur during storage; has a characteristic cresol odor.

Pharmacotherapeutic group.

Antimicrobial agents for systemic use. Immune serum.

ATC code J06A A02.

Immunological and biological properties.

Pharmacodynamics.

Tetanus antitoxin is obtained from blood of horses immunized with toxin of Clostridium tetani. Plasma obtained from blood of healthy immunized horses is enzymatically purified and concentrated. Tetanus antitoxin contains specific antitoxic globulins which neutralize the toxin produced by Clostridium tetani, the causative agent of tetanus.

Pharmacokinetics. Not applicable.

Clinical characteristics.

Indications.

The medicinal product Tetanus antitoxin is indicated for passive therapeutic and prophylactic immunization of children and adults at risk of developing tetanus due to wound contamination or following severe injuries.

Contraindications.

The use of the medicinal product Tetanus antitoxin is contraindicated in individuals with a history of allergic reactions to horse proteins, as well as in patients suffering from asthma and atopic dermatitis. In case of anaphylactic reaction, epinephrine must be readily available, along with the means to provide supportive therapy.

Special precautions.

Residual serum and used vials must be disposed of as medical-biological waste.

Interaction with other medicinal products and other forms of interaction.

Immunoglobulins may interfere with the ability of live vaccines to induce an immune response.

Special precautions.

Individuals who have received the product must remain under medical supervision for 30 minutes.

The medicinal product Tetanus Antitoxin contains less than 1 mmol (23 mg)/dose of sodium, i.e. it is practically sodium-free.

Serum reaction.

Patients receiving Tetanus Antitoxin must be tested for hypersensitivity using a test dose. The sensitivity test is performed by administering 0.1 ml of the Tetanus Antitoxin preparation, diluted 1:10 with physiological saline, subcutaneously or intradermally. The patient must then be observed for 30 minutes for any local or systemic reaction. If a hypersensitivity reaction occurs, Tetanus Antitoxin should be administered with great caution, in small divided doses, subcutaneously, with strict 30-minute intervals. In case of shock, epinephrine (1:1000) should be injected and supportive therapy provided.

Use during pregnancy or breastfeeding.

Pregnancy is not a contraindication to the use of the medicinal product Tetanus Antitoxin unless clearly contraindicated.

Breastfeeding is not a contraindication to the use of the medicinal product Tetanus Antitoxin unless clearly contraindicated. It is not known whether the active substance of Tetanus Antitoxin passes into breast milk.

Ability to influence reaction rate while driving or operating machinery.

Not observed.

Method of Administration and Dosage

Tetanus antitoxin is administered prophylactically to individuals at risk of developing tetanus due to infected or severe wounds. A dose of 1000 IU is given intramuscularly or subcutaneously; in severe wounds, the dose may be doubled or tripled. For severe wounds, Tetanus antitoxin is administered intramuscularly into the upper outer quadrant of the gluteal muscle. Along with passive immunization, active immunization with adsorbed tetanus toxoid is advisable.

Patients with body weight less than 29.5 kg should receive 1500 IU as a single dose. If the patient's body weight exceeds 29.5 kg, a single dose of 3000 IU to 5000 IU should be administered, depending on the size of the injury and the degree of wound contamination.

Children.

Tetanus antitoxin is used as indicated in pediatric practice.

Overdose.

The dose usually depends on the severity of infection. In case of overdose, symptomatic treatment is provided and supportive therapy is recommended.

Side effects.

The use of the medicinal product Tetanus Antitoxin may be accompanied by various immediate-type allergic reactions (occurring immediately after administration or within several hours) and delayed-type hypersensitivity reactions (on days 2–6 or during the 2nd week and later).

Very rare (< 1/10,000): hypersensitivity reaction.

Rare (> 1/10,000 – < 1/1,000): serum sickness-like symptoms, which may include fever, pruritus, urticaria, skin rash, skin hyperemia, joint and muscle pain, etc.

In some cases, symptoms such as pruritus, urticaria, joint and muscle pain, fever, and lymphadenopathy may appear approximately 7–12 days after administration of tetanus antitoxin. Treatment with antihistamines and corticosteroids should be administered. Typically, the described symptoms of serum sickness last for several days, and patients recover without complications.

Shelf life: 2 years.

After the first opening of the vial, the solution should be used immediately.

Storage conditions: Store at a temperature of 2 to 8 °C. Do not freeze. Store in a protected from light place.

Packaging: 1 ml in a vial. 10 vials per cardboard box.

Prescription status: Prescription only.

Manufacturer: VINS BIOPRODUCTS LIMITED.

Manufacturer's address and place of business activity:

No. 117, Thimmapur, Kothur Mandal, Ranga Reddy District, Telangana State, India.