Dose Administration

One dose (0.5 mL) of the vaccine is to be administered by intramuscular route. The number of doses and interval between doses have to be decided as per indication.

Indications

• Tetanus vaccine is indicated as prophylaxis for all age groups above 6 weeks of age. Tetanus toxoid vaccine alone is indicated as part of wound and animal bite management and as a booster dose for children, adolescents and adults.
• It can be administered as booster dose or catch up primary vaccination to persons who are at increased risk of attaining injuries through their occupation or recreation activities.

Adverse Effects

Abhay-TOX® vaccine is generally well tolerated.

Local Reaction: Redness, warmth, edema, induration with or without tenderness as well as urticaria and rash.

Systemic Reaction: Malaise, transient fever, pain, hypotension, nausea and arthralgia may develop in some patients after the injection.

Arthus-type hypersensitivity type reactions, characterized by severe local reaction (generally Starting 2 to 8 hrs after an injection may occur, particularly in persons who have received multiple prior booster doses of tetanus toxoid containing vaccine. Rarely anaphylaxis can also occur.

The following neurological illnesses have been reported as temporarily associated with tetanus paralysis of the radial nerve, paralysis of the recurrent nerve, accommodation paresis and EEG disturbances with encephalopathy. There may be a casual relation between Guillain-Barre syndrome (GBS) and vaccines containing tetanus toxoid.

Warnings

• Tetanus vaccine should not be administered more frequently than once in 10 years for booster except in the following cases: In case of bad wounds booster doses are indicated if last dose was administered more than 5 years earlier.
• For a person who has experienced severe hypersensitivity reaction during the previous dose should not be administered with the vaccine more frequently than 10 years even if they have a badwound.
• Tetanus vaccine should not be administered to persons with any bleeding disorder, such as hemophilia or thrombocytopenia or to persons on an anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration.

Special Precautions for Storage

• Store the vaccine in a dry, dark place at a temperature of +2° C and +8° C.
• DO NOT FREEZE.
• Transport the vaccine at a temperature of +2° C and +8° C.
• Discard the ampoule if contents are frozen.

Contraindications

• Hypersensitivity to any component of the vaccine.
• Anaphylaxis or other serious allergic reaction following a previous dose of this vaccine, any other tetanus toxoid containing vaccine, or any component of this vaccine.
• Immunization should be deferred during the course of any febrile illness or acute infection. A minor febrile illness such as mild upper respiratory infection is not a contraindications.