Human Tetanus Immunoglobulin is indicated for:

• Prophylaxis of tetanus following injury in patients with incomplete or uncertain immunization status
• Therapeutic use in the treatment of tetanus

Tetanus immunoglobulin should be administered together with active tetanus vaccination, unless contraindicated.

Human Tetanus Immunoglobulin is a sterile solution containing antibodies against tetanus toxin. It is prepared from human plasma of donors with high levels of tetanus antibodies using Cohn fractionation. A heat inactivation step (60°C for 10 hours) is included during manufacturing to eliminate infectious agents such as Hepatitis B virus, Hepatitis C virus, and Human Immunodeficiency Virus (HIV).

Human tetanus immunoglobulin neutralizes tetanus toxin, preventing it from damaging tissues and causing the clinical manifestations of tetanus. The antibodies bind to the toxin and block its interaction with human tissues, thereby preventing symptoms such as muscle spasms and autonomic dysfunction. The tetanus bacteria are eliminated by antibiotics and the immune system, while toxin-antibody complexes are removed by phagocytic cells.

Post-exposure prophylaxis of tetanus:

• For adults and children, a single dose of 250 IU is recommended. The dose may be increased to 500 IU in the following situations:
• Infected wounds where proper surgical treatment cannot be performed within 24 hours
• Deep or contaminated wounds with tissue damage and reduced oxygen supply, or injuries involving foreign bodies (e.g., bites, stings, or gunshot wounds)
• Burns and frostbite
• Tissue necrosis
• Septic abortion
• Adults with body weight above average

In cases of extensive burns, a second dose of 250 IU human tetanus immunoglobulin may be administered after the exudative phase of the burn has subsided (approximately 36 hours after onset).

At the same time, 0.5 mL of tetanus vaccine should be administered in a different limb using a separate syringe, and a complete immunization schedule should be followed.

Therapy of clinically manifest tetanus: For adults and children, single doses of 3,000–6,000 IU are recommended in combination with appropriate clinical management.

Administration: Human Tetanus Immunoglobulin should be administered only by intramuscular injection and must not be given intravenously.

Do not use solutions that appear cloudy or contain particles.

The preparation is ready for use and should be administered at body temperature. If large volumes are required, divide the dose and administer at different injection sites.

In patients with severe coagulation disorders where intramuscular injection is contraindicated, the drug may be given subcutaneously for prophylaxis, followed by compression at the injection site. However, clinical efficacy of the subcutaneous route is not well established.

Co-administration: Human tetanus immunoglobulin may reduce the effectiveness of live attenuated vaccines (such as measles, mumps, rubella, and varicella) for up to 3 months.

After administration, an interval of at least 3 months should be maintained before giving live vaccines. In the case of measles vaccine, this reduced response may persist for up to 5 months; therefore, antibody status should be checked before vaccination.

May reduce the effectiveness of live vaccines.

• Known hypersensitivity to any component of the product
• Known hypersensitivity to human immunoglobulins
• As with other intramuscular injections, human tetanus immunoglobulin is not recommended in patients with bleeding disorders
• In patients with a history of immunoglobulin A (IgA) deficiency or severe anaphylactic reactions to plasma products, the risk-benefit ratio should be carefully evaluated

Adverse reactions following administration of human tetanus immunoglobulin are usually rare and mild, though severe local or systemic reactions may occasionally occur.

• Local reactions at injection site: Pain, tenderness, or swelling

In rare cases, the following reactions may occur:

• Immune system disorders: Allergic reactions including low blood pressure, shortness of breath, skin reactions, and in some cases severe anaphylactic shock, even without prior hypersensitivity
• General reactions: Chills, fever, headache, malaise, nausea, vomiting, joint pain, and moderate back pain
• Cardiovascular disorders: Cardiovascular reactions, especially if the product is accidentally injected intravenously

The safety of human tetanus immunoglobulin during pregnancy has not been fully established in controlled clinical trials. However, long-term clinical experience suggests that no harmful effects on pregnancy, the fetus, or the newborn are expected.

Should not be administered intravenously.

A separate sterile syringe must be used for each patient to reduce the risk of transmission of hepatitis B and other infectious diseases.

Use with caution in patients who have previously shown systemic allergic reactions to immunoglobulin. Epinephrine (0.1–0.5 mL, 1:1000) should be readily available for emergency use.

In patients with severe thrombocytopenia or coagulation disorders where intramuscular injection is contraindicated, human tetanus immunoglobulin should be given only if the expected benefits outweigh the risks.

Before administration, the syringe plunger should be gently withdrawn to ensure that the needle is not positioned within a blood vessel.

Although prepared from human plasma and treated to minimize viral transmission risk, the possibility of unknown viral infections (e.g., Parvovirus B19) cannot be completely excluded. Patients should be monitored for a prolonged period after administration.

Not applicable.

Vaccines, Anti-sera & Immunoglobulin

Keep out of the sight and reach of children. Store at +2°C to +8°C. During transportation, maintain the temperature between +2°C and +8°C. Do not freeze. Discard if frozen. Protect from light.