Abhay-TOX

Abhay-TOX Tetanus vaccine is a sterile suspension of Aluminium phosphate adsorbed tetanus toxoid in isotonic sodium chloride solution. The vaccine, after shaking, is a uniformly turbid liquid, whitish in color.
Each dose of 0.5 mL contains: Tetanus Toxoid ≥40 IU (5 to 25 Lf), Aluminum Phosphate (AlPO₄) as Al⁺⁺⁺ ≤1.25 mg, Thiomersal (as preservative) 0.01% w/v, Saline q.s. to 0.5 mL.

Pharmacology: The tetanus vaccine contains tetanus toxoid antigen which is formaldehyde treated exotoxin of Clostridium tetani. The antigen induces development of neutralizing antibodies to tetanus toxin resulting in protection against tetanus infection.

For prevention of tetanus in all age groups above 6 weeks following injury or animal bite.
It can be given to persons who are at increased risk of attaining injuries through their occupation or recreational activities.
It is also indicated for prevention of neonatal tetanus in pregnant women.

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 as per age at appropriate interval.
Immunization in pregnant women: For prevention 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 in pregnancy. A five dose schedule is recommended for previously unimmunized women of child bearing 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.
Immunization in Injured Persons: Immunization with Tetanus vaccine is indicated after injury or animal exposure. Number of doses required as per the previous immunization status has been summarized in the following table: See table.

Click on icon to see table/diagram/image

Administration: Shake the vial to disperse the contents thoroughly immediately before withdrawing each dose of vaccine. A sterile disposable syringe and 24 gauge needle should be used for each injection.
The vaccine is administration deep intramuscularly in the anteriolateral aspect of thigh in children and in the deltoid region in adolescents and adults. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

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 tract infection is not a contraindication.

Tetanus vaccine should not be given more frequently than once in every 10 years for booster unless indicated otherwise by specific condition.
For a person who has experienced severe Arthus type hypersensitivity reaction during the previous dose should not be administered with the vaccine more frequently than 10 years even if they have a bad wound.
Tetanus vaccine should not be given to persons with any bleeding disorder, such as hemophilia or Thrombocytopenia or to persons on anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration.
Pregnant woman if infected with malaria, the transplacental transfer of antitoxin may be impaired.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.

An antihistamine may be indicated for mild allergic reactions.
The vaccinee should be observed for 30 to 60 minutes after administration of vaccine for any immediate reactions. This would help in prompt management of the adverse reaction, if any, and can be potentially reversed with proper and timely treatment.
For anaphylactic reactions, adrenaline/epinephrine (1 in 1000) may be used. For treatment of severe anaphylaxis the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5 mL of 1:1000 injection) given s/c or i/m. Single dose should not exceed 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 injection). Single paediatric dose should not exceed 0.5 mg (0.5 mL).
Antihistamines, hydrocortisone IV fluids and other appropriate medications should also be used as per requirement.
There is a chance of increased incidence of reactions to booster doses of Tetanus toxoid vaccine when given to previously immunized persons.
Care should be taken to ensure that injection does not enter into a blood vessel.

Pregnancy: There is extensive human experience in the administration of Tetanus vaccine and there is no evidence of teratogenicity.
Lactation: There is no information on the excretion of Tetanus vaccine antigens or antibodies in breast milk during breast-feeding; however, it is unlikely that there is passage of the vaccine.

Abhay-TOX is generally well tolerated.
Local reactions: Redness, warmth, edema, induration with or without tenderness as well as urticaria and rash.
Systemic reactions: Malaise, transient fever, pain, hypotension, nausea and arthralgia may develop in some patients after the injection.
Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hrs after an injection) may occur, particularly in persons who have received multiple prior booster doses of a Tetanus toxoid-containing vaccine. Rarely anaphylaxis can also occur.
The following neurologic illness have been reported as temporarily associated with tetanus toxoid: neurological complications including cochlear lesion, brachial plexus neuropathies, 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.

Routine vaccination should be deferred, if possible, in patients who are receiving immunosuppressive therapies including radiation, corticosteroids, antimetabolites, all alkylating agents and cytotoxic drugs as they may reduce the immune response to vaccines.
The vaccine can be safely and effectively given simultaneously with other vaccines if needed.
As with other intramuscular injections, caution should be taken in patients on anticoagulant therapy.

Instructions for Use and Handling: Gently shake well before use.
Discard if vaccine cannot be re-suspended.
Abhay-TOX must not be diluted to administer.
Use new sterile syringe and needle for every administration.
Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of vaccine.

Special Precautions for Storage: Protect from light.
Do not freeze.
Discard vial if contents are frozen.
Abhay-TOX must be stored and transported between +2°C and +8°C.
Once opened, multi-dose vials should be kept between +2°C and +8°C. Multi-dose vials of Tetanus vaccine from which one or more doses of vaccine have been removed during an immunization session may be used in subsequent immunization sessions for up to a maximum of 4 weeks, provided that all of the following conditions are met (as described in the WHO policy statement: The use of opened multi dose vials in subsequent immunization sessions).
The expiry date has not passed.
The vaccines are stored under appropriate cold chain conditions.
The vaccine vial septum has not been submerged in water.
Aseptic technique has been used to withdraw all doses.
Shelf Life: Three years from the date of manufacture.

Vaccines, Antisera & Immunologicals

J07AM01 - tetanus toxoid ; Belongs to the class of tetanus bacterial vaccines.

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