Indications
- For the active immunization of infants, children 7 years of age or older and adults against tetanus, wherever combined antigen preparations are not indicated.
- For the prevention of neonatal tetanus in infants by immunizing women of childbearing age or infants bom of unvaccinated pregnant women.
- Those who are liable to be exposed to tetanus infection and persons engaged in outdoor activities e.g. gardeners, agricultural, veterinary, athletes, industrial, sewage, road and outdoor workers, etc.
- This vaccine is not to be used for the treatment of tetanus infection. If passive immunization is required, Tetanus Immunoglobulin (TIG) should be used.
Therapeutic Class
Vaccines, Anti-sera & Immunoglobulin
Pharmacology
Tetanus toxoid adsorbed is a sterile suspension on aluminium phosphate suspended in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color. Adsorbed tetanus toxoid is prepared from tetanus toxin, produced by the growth of the bacterium Clostridium tetani in a peptone-based media. The toxin is converted to tetanus formol toxoid by treatment with formaldehyde solution. Formol tetanus toxoid is then purified, sterile, filtered and adsorbed to the aluminium phosphate.Thiomersal is added as preservative.
Dosage
Primary immunization for persons 7 years of age and older-
A series of three doses of 0.5 ml each, of adsorbed tetanus vaccine should be given intramuscularly- First dose: At appropriate date
- Second dose: 4 to 8 weeks after the first dose
- Third dose: 6 to 12 months after the second dose
Routine booster injections: To maintain adequate protection, a booster dose of 0.5 ml of adsorbed tetanus vaccine every 10 years thereafter is recommended.
Vaccination of injured persons-
Clean and minor wound:- If primary immunization confirmed and receiving booster dose within previous 5 years, no need of additional vaccine.
- If primary immunization confirmed and receiving booster dose more than previous 5 years, 1 dose of 0.5 ml required.
- If primary immunization confirmed and receiving booster dose within previous 5 years, 1 dose of 0.5 ml required.
- If primary immunization confirmed and receiving booster dose more than previous 5 years, 1 dose of 0.5 ml along with tetanus immunoglobulin required.
Protection of neonatal tetanus-
For prevention of neonatal tetanus, adsorbed tetanus vaccine is recommended for immunization of women of childbearing age.Women (15-49 Years): For pregnant woman who have not had previous immunization, 2 doses of tetanus toxoid at four weeks interval preferably during the last two trimester or at least 2 weeks before delivery should be given during pregnancy so that protective antibody would be transferred to the infant in order to prevent neonatal tetanus, e.g. 1 dose of 0.5 ml at 6th month of pregnancy and 1 dose of 0.5 ml at 7th month of pregnancy. Pregnant woman who have completed the course of tetanus, next 10 years no need of additional dose during pregnancy. Thereafter a single booster dose would be sufficient to extend immunity.
Administration
Method of administration: Adsorbed Tetanus Vaccine is for intramuscular injection only. Do not inject intravenously. For adults and older children Adsorbed Tetanus Vaccine should be given intramuscularly in the deltoid muscle. For infants Adsorbed Tetanus Vaccine should be given intramuscularly in the anterolateral aspect of the upper thigh. It should not be injected into the gluteal areas as the immune response may be lower. The attending physician should determine final selection of the injection site and needle size, depending upon the patient's age and the size of the target muscle. The vaccine should be shaken well before use to obtain a homogenous turbid white suspension. Please do not shake vigorously.
Preparation for administration:
Preparation for administration:
- The vaccine should be shaken well before use to obtain a homogenous turbid white suspension. Please do not shake vigorously.
- The vaccine should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.
- The vaccine should be used as supplied; no dilution is necessary.
- The full recommended dose of the vaccine should be used. Any vaccine remaining in a single-dose ampoule/vial should be discarded.
Interaction
Decreased immunologic response with concurrent immunosuppressants. Neutralisation of tetanus immune globulin and tetanus toxoid adsorbed if not given at different sites using different syringes.
Contraindications
Hypersensitivity to any component of the vaccine, including thiomersal, is a contraindication. This vaccine is contraindicated in patients with previous hypersensitivity to any tetanus-containing vaccine. Tetanus toxoid vaccination should be defferred during the course of any febrile illness or acute infection. A minor febrile illness such as a mild upper respiratory infection should not preclude immunization.
Side Effects
Adsorbed tetanus vaccine is generally well tolerated. Most recipients of tetanus vaccine experience some reactions upon vaccination. These are generally moderate and short in duration. They mainly consist of local reactions at the injection site (erythema, induration and tenderness). Systemic reactions (malaise and elevated temperature) are reported less commonly.
Pregnancy & Lactation
For protection of neonatal tetanus, tetanus toxoid is recommended for immunization of women of childbearing age and especially pregnant women. Tetanus toxoid may be safely administered during pregnancy and should be given to the mother at first contact or as early as possible. It is not known if tetanus toxoid is excreted in human milk. It may be administered to nursing mothers only if clearly needed.
Precautions & Warnings
Do not administer IV. Use subcutaneous route in bleeding disorders. Withhold vaccination in moderate or severe febrile illness. Pregnancy, lactation, history of Guillian-Barre syndrome.
Storage Conditions
Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8°C. Do not freeze. Discard vaccine if frozen. Protect from light.