For the use of Registered Medical Practitioner or hospital or laboratory only
TETANUS VACCINE (ADSORBED) I.P. DANO – TT
For Active Immunization against Tetanus
DESCRIPTION
Tetanus Vaccine (Adsorbed) I.P. is a suspension of injection in single dose (0.5 ml) ampoule and 10 doses (5 ml) in vials. The vaccine is whitish turbid liquid in which the mineral carrier (adjuvant) tends to settle down on keeping. The vaccine contains purified tetanus toxoid. The toxoid is adsorbed onto Aluminium Phosphate (mineral carrier). Thiomersal is used as preservative.
The vaccine is indicated to use for active immunization against tetanus.
COMPOSITION
Each dose of 0.5 ml contains
| Tetanus toxoid | ≥5Lf to ≤25 Lf |
| Aluminium Phosphate (Mineral Carrier) | 1.5 mg |
| Thiomersal IP (Preservative) | 0.01% w/v |
ADMINISTRATION
Shake well before withdrawing each dose to homogenize the suspension, avoid foaming. Discard if vaccine cannot be resuspended to a homogenous suspension.
Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.
Inject intramuscularly deep into the deltoid muscle in adults and older children or anterolateral aspect of upper thigh (mid-thigh laterally) in younger children. The vaccine should not be injected into the gluteal areas where there may be a major nerve trunk.
A sterile needle and a sterile syringe should be used for each injection. The vaccine should be visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.
IMMUNIZATION SCHEDULE
TT Immunization for the prevention of tetanus / neonatal tetanus consists of two primary doses of 0.5 ml given intramuscularly at least four weeks apart followed by the third dose, at least 6 months later. To maintain the immunity of women against tetanus through the child – bearing period, a total of five doses are recommended. A fourth dose should be given at least one year after the third dose, and a fifth dose at least one year after the fourth dose.
TT immunization can be administered during pregnancy even during the first trimester. In previously non-immunized women, two doses of TT are recommended in pregnancy, at least 4 weeks apart, the second dose should be given at least two weeks before child birth, in order to prevent maternal and neonatal tetanus. Tetanus toxoid should also be given in situations where a risk of developing tetanus from any other source exists. (e.g. injuries). At least two doses with at least one month interval will be required to provide basic protection in a previously unimmunized person, and additional booster dose will be required to maintain protection over time. Refer national immunization schedules for more details.
Where administration of tetanus immunoglobulin is indicated (e.g., tetanus prone wound) the vaccine should be administered at a separate site, with separate needle and syringe.
Persons who have not completed primary immunization against tetanus, or whose immunization history is unknown or uncertain, should be immunized with tetanus toxoid. Full cycle of vaccinations plan is 0-1, 6-12 month. (Two initial doses in time intervals not shorter than 4-6 weeks, the third supplementary dose after 6 months to 1 year from the second vaccination). Booster vaccination, one dose every 10 years from the last vaccination.
TT may be given at the same time as BCG, measles, rubella, mumps, polio (OPV and IPV) Hepatitis B, Haemophilus influenza type b and yellow fever vaccines and vitamin A supplementation.
SIDE EFFECTS
Rare and mild. Some temporary tenderness, redness and pain may develop at the site of the injection and occasional fever. It is safe to be given during pregnancy. Persistent nodules at the site of injection have occurred following the use of adsorbed vaccines, but this complication is unusual. General reactions are uncommon but may include headache, lethargy, malaise, myalgia. Acute anaphylatic reactions, urticaria, angioneurotic oedema, serum sickness and peripheralneuropathy occasionally occur.
CONTRAINDICATIONS
It is a contraindication to use this vaccine after 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. The vaccine should not be administered to anyone with high fever or other evidence of acute illness.
PRECAUTIONS
GENERAL
Care is to be taken by the health – care provider for the safe and effective use of Tetanus Toxoid Adsorbed manufactured by Dano Vaccines & Biologicals Pvt Ltd.
EPINEPHRINE INJECTION (1:1000) AND OTHER APPROPRIATE AGENTS AND EQUIPMENT MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THE VACCINE
IMMUNE DEFICIENCY:
Persons infected with human immunodeficiency virus (HIV) whether asymptomatic or symptomatic, should be immunized with TT vaccine according to standard schedules.
STORAGE
TT should be stored and transported between 2°C to 8°C. IT MUST NOT BE FROZEN.
Once opened Multi – dose vials should be kept between 2°C to 8°C. and Multi – dose vials of T T 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. WHON&B/00.09):
If not sure of the above conditions, it is recommended to discard the multidose presentation at the end of day’s shift.
SHELF LIFE
Thirty six months from the date of manufacture.
PRESENTATION
The vaccine comes in :
- 0.5 ml (one dose) in Ampoule, Pack size 50×0.5 ml Ampoules
- 5 ml (Ten doses) in Vial, Pack size 50×5 mI Vials