Vaxitet IM Injection 0.5 ml vial

Tetanus toxoid (adsorbed) BP preparation prepared by detoxification of the sterile filtrate of broth cultures of Clostridium tetani with formalin and heat. The toxoid is purified by chemical methods and is adsorbed onto aluminium phosphate as adjuvant. Thiomersal is added as preservative. The vaccine has the appearance of a greyish-white suspension and does not contain any horse serum protein. Therefore it does not induce sensitization to sera of equine origin. The vaccine meets the requirements of WHO, when tested by the methods outlined in WHO, TRS. (1990), 800.

The full basic course of immunization against tetanus consists of two primary doses of 0.5 ml at least four weeks apart, followed by the third dose 6-12 months later. To maintain a high level of immunity further 0.5 ml. booster doses are recommended at every feasible interval (for adults usually 5 to 10 years).

Protection of the Newborn against Tetanus: For prevention of neonatal tetanus, Tetanus Toxoid vaccine is recommended for immunization of women of childbearing age, and especially pregnant women. Tetanus Toxoid vaccine may be safely administered during pregnancy and should be given to the mother at first contact or as early as possible in pregnancy. A five dose schedule is recommended for previously unimmunized women of childbearing age: after the basic course of immunization with three doses, two additional booster doses should be given, at least one year after the previous dose or during the subsequent pregnancy.

Vaccination of Injured Person: For those subjects who have proof of either completing their course of primary immunizations containing tetanus toxoid or receiving a booster shot within the previous 5 years no additional dose of tetanus toxoid is recommended. If more than 5 years have elapsed, and infection with tetanus because of injury or other cause is suspected, 0.5ml of the Tetanus Toxoid vaccine should be given immediately. Where the immunization history is inadequate 1500 IU (3000 old AU) tetanus antiserum and 0.5 ml Tetanus Toxoid vaccine should be injected, with separate syringes, to different body sites. (If available, 250 units of tetanus immune globulin (human origin) can be substituted for the tetanus antiserum). A second 0.5ml dose of Tetanus Toxoid vaccine is recommended after 2 weeks and a third dose after a further 1 month.

A note of caution: if horse-origin tetanus antiserum is used in prophylaxis, the patient should be tested for sensitivity to horse serum protein prior to its administration. It is desirable to have 1 ml of Adrenaline solution (1:1000) immediately available and the normal precautions followed when injecting antitoxins.

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

Reactions: Reactions are generally mild and confined to the site of injection. Some inflammation may occur together with transient fever, malaise and irritability. Occasionally a nodule may develop at the site of injection but this is rare. An increased severity of reactions to vaccination may be observed in subjects. Who have had many booster immunizations.

If passive immunization for tetanus is needed, TIG (Human) is the product of choice. It provides longer protection than antitoxin of animal origin and causes few adverse reactions. As with other intramuscular injections, use with caution in-patients on anticoagulant therapy. Immunosuppressive therapies may reduce the immune response to vaccines.

The vaccine should not be given to persons who showed a severe reaction to a previous dose of tetanus toxoid. Immunization should be deferred 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.

Vaxitet 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.

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.

For treatment of severe anaphylaxis the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5 ml of 1:1000 injections) given s/c or i/m. Single dose should not exceed 1 mg (1ml). For infants and children, the recommended dose of adrenaline is 0.01mg/kg (0.01ml/kg of 1:1000 injection). Single paediatric dose should not exceed 0.5 mg (0.5ml). The mainstay in the treatment of severe anaphylaxis is the prompt use of adrenaline, which can be lifesaving. It should be used at the first suspicion of anaphylaxis.

As with the use of all vaccines the vaccinees should remain under observation for not less than 30 minutes for possibility of occurrence of immediate or early allergic reactions. Hydrocortisone Sodium Succinate and antihistaminics should also be available in addition to supportive measures such as oxygen inhalation.

There is an increased incidence of local and systemic reactions to booster doses of Tetanus Toxoid when given to previously immunized persons. Special care should be taken to ensure that the injection does not enter a blood vessel.

It is extremely important when the parent, guardian, or adult patient returns for the next dose in the series, the parent, guardian, or adult patient should be questioned concerning occurrence of any symptoms and/or signs of an adverse reaction after the previous dose.

Vaccines, Anti-sera & Immunoglobulin

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.