TTvax 40 IU/0.5 ml

Generic: Adsorbed tetanus vaccine

Manufacturer

Popular Pharmaceuticals Ltd.

Interaction

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.

Contraindications

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.

Side Effects

TTvax 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.

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Description

Indications

This vaccine is used for the prevention of tetanus in children 7 years of age or older and adults, especially those liable to be exposed to tetanus infection and persons engaged in outdoor activities e.g. gardeners, farm workers and athletes. This vaccine is also used in the prevention of neonatal tetanus by immunizing women of childbearing age, and also in the prevention of tetanus following injury. The vaccine can be safely and effectively given simultaneously with BCG, Measles, Polio vaccines (IPV and OPV), Hepatitis B, Yellow fever vaccine, Haemophilus influenzae-B and Varicella vaccine.

HIV Infection: TTvax may be used in children with known or suspected HIV infection. Although the data are limited and further studies are being encouraged, there is no evidence to date of any increased rate of adverse reactions using this vaccine in symptomatic or asymptomatic HIV infected children.

Pharmacology

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.

Dosage & Administration

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.

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