Vaxitet Ampoule

Indications

This vaccine is essential for preventing tetanus in individuals aged 7 years and older, particularly those at risk of exposure to tetanus, such as gardeners, farm workers, and athletes. Additionally, it plays a crucial role in preventing neonatal tetanus by immunizing women of childbearing age. It is also administered to prevent tetanus following injuries. This vaccine can be safely and effectively administered alongside other vaccines, including BCG, measles, polio (IPV and OPV), hepatitis B, yellow fever, Haemophilus influenzae type B, and varicella vaccines.

HIV Infection: Vaxitet is suitable for children with known or suspected HIV infection. Current data are limited, but studies indicate no increased rate of adverse reactions in symptomatic or asymptomatic HIV-positive children following vaccination.

Consult a registered physician before use.

Pharmacology

Vaxitet contains tetanus toxoid (adsorbed) BP, created through detoxifying the sterile filtrate from Clostridium tetani cultures using formalin and heat. The toxoid is purified through chemical processes and adsorbed onto aluminum phosphate as an adjuvant. Thiomersal is added as a preservative. The vaccine appears as a greyish-white suspension and does not include horse serum protein, thus minimizing the risk of sensitization to equine serum. Vaxitet complies with WHO standards as outlined in WHO TRS (1990), 800.

Dosage & Administration

The complete immunization course against tetanus includes two primary doses of 0.5 ml, administered at least four weeks apart, followed by a third dose 6 to 12 months later. To ensure sustained immunity, additional booster doses of 0.5 ml are recommended every 5 to 10 years for adults.

Protection of Newborns Against Tetanus: For neonatal tetanus prevention, it is vital to immunize women of childbearing age, especially during pregnancy. The tetanus toxoid vaccine can be safely given during pregnancy, ideally at the first contact or as early as possible. A five-dose schedule is recommended for previously unimmunized women of childbearing age: following three initial doses, two booster doses should be administered at least one year after the last dose or during the subsequent pregnancy.

Vaccination Following Injury: Individuals with documented completion of their primary immunization series containing tetanus toxoid or who have received a booster within the last five years do not require an additional dose. If more than five years have passed and tetanus infection is suspected due to an injury, a 0.5 ml dose of tetanus toxoid vaccine should be administered immediately. If immunization history is inadequate, both 1500 IU (3000 old AU) of tetanus antiserum and 0.5 ml of tetanus toxoid vaccine should be injected at separate sites using different syringes. Alternatively, if available, 250 units of human-origin tetanus immune globulin may replace the tetanus antiserum. A second 0.5 ml dose of tetanus toxoid vaccine is recommended two weeks later, with a third dose one month after that.

Caution: If using horse-origin tetanus antiserum for prophylaxis, it’s critical to test for sensitivity to horse serum protein beforehand. Keep 1 ml of adrenaline solution (1:1000) readily available, and follow standard precautions when administering antitoxins.

Method of Inoculation: The vaccine should be injected intramuscularly into the deltoid muscle of women and older children. Only sterile needles and syringes should be used for each injection. The vaccine must be well shaken before use. Once opened, multi-dose vials should be stored between 2°C and 8°C.

Reactions

Most reactions are mild and localized to the injection site, with potential symptoms including inflammation, transient fever, malaise, and irritability. Occasionally, a nodule may form at the injection site, though this is rare. Individuals who have received numerous booster shots may experience more severe reactions.

Consult a registered physician before use.

Interaction

If passive immunization for tetanus is necessary, human Tetanus Immune Globulin (TIG) is preferred, offering longer protection and fewer adverse reactions compared to animal-origin antitoxin. Caution should be exercised when administering intramuscular injections to patients on anticoagulant therapy. Immunosuppressive treatments may diminish the immune response to vaccines.

Contraindications

Individuals who have experienced severe reactions to previous doses of tetanus toxoid should not receive the vaccine. Immunization should be postponed during febrile illnesses or acute infections; however, mild illnesses, like a mild upper respiratory infection, do not necessarily prevent immunization.

Side Effects

Vaxitet is generally well-tolerated. While most recipients may experience some reactions following vaccination, these are typically mild and of short duration, primarily consisting of local reactions (erythema, induration, and tenderness). Systemic reactions (malaise and elevated temperature) are less common.

Pregnancy & Lactation

To protect newborns from tetanus, the tetanus toxoid vaccine is recommended for immunization of women of childbearing age, particularly during pregnancy. The vaccine can be safely administered during pregnancy, ideally at the first contact. Its excretion in human milk is unknown, so it may be given to nursing mothers only when absolutely necessary.

Precautions & Warnings

For treating severe anaphylaxis, the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5 ml of 1:1000 solution), administered subcutaneously or intramuscularly, with a maximum single dose of 1 mg (1 ml). For infants and children, the recommended dose of adrenaline is 0.01 mg/kg (0.01 ml/kg of 1:1000 solution), not exceeding 0.5 mg (0.5 ml) in a single pediatric dose. Prompt use of adrenaline is critical and can be life-saving at the first suspicion of anaphylaxis.

As with all vaccines, individuals should be monitored for at least 30 minutes post-vaccination for immediate allergic reactions. Hydrocortisone Sodium Succinate and antihistamines should be readily available, along with supportive measures such as oxygen inhalation.

An increased incidence of local and systemic reactions may occur with booster doses of tetanus toxoid in previously immunized individuals. Care must be taken to ensure the injection does not enter a blood vessel.

It’s crucial to question patients or guardians about any adverse reactions after previous doses when they return for the next immunization.

Therapeutic Class

Vaccines, Anti-sera & Immunoglobulin

Storage Conditions

Keep out of reach of children. Store between 2°C and 8°C. Transportation must also be maintained at 2°C to 8°C. Do not freeze; discard the vaccine if frozen. Protect from light.