Active Immunization against Tetanus.
Sii Tetanus Toxoid (Adsorbed) as supplied by Serum institute of
India Ltd. is a sterile, whitish turbid, uniform suspension of tetanus
toxoid adsorbed on aluminium phosphate and suspended in isotonic
sodium chloride solution.
Each dose of 0.5 ml human dose contains:
This vaccine fulfils the I.P. requirements for
Tetanus Toxoid (Adsorbed)
Aluminium Phosphate (AlPO4)
||0.01 % as preservative
As Tetanus can occur in cases of even minor injuries it is advisable
to actively immunize every person in general. With this aim in view,
it is desirable: To actively immunize all children from the age
of 6 weeks onwards.
- To protect infants against the risks of tetanus
neonatorum by immunizing pregnant mothers.
- To actively immunize civil population particularly
those who are exposed to occupational risks such as road workers,
athletes agricultural workers, industrial workers etc.
- To actively immunize civil and defense personnel,
home guards and police personnel.
The full basic course of immunisation against tetanus toxiod consists of three primary doses of 0.5ml at least four weeks apart, followed by booster doses at 18 months, 5 years, 10 years and 16 years and then every 10 years.
PROTECTION OF THE NEW BORN AGAINST TETANUS
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. Pregnancy: After completing the full basic course of 7 doses, there is no need for
additional doses during pregnancy at least for the next 10 years; thereafter a single booster would be sufficient to extend immunity for another 10 years. For pregnant woman who have not had previous immunisation, at least 2 doses of tetanus toxoid at four weeks interval, 2 dose at least 2 weeks before delivery should be given during pregnancy so that protective antibody would be transferred to the infant in order to prevent neonatal tetanus.
VACCINATION OF INJURED PERSONS
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 adsorbed tetanus
toxoid should be given immediately. Where the immunization history
is inadequate 1500 IU tetanus antiserum and 0.5ml Tetanus toxoid
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 toxoid is recommended after 2 weeks and a
third dose after a further 1 month.
(A note of caution : if Tetanus antiserum from heterologous origin
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 Epinephrine Hydrochloride solution (1 : 1000) immediately
available and the normal precautions followed when injecting antitoxins).
The vaccine should be administered by deep intramuscular injection.
Tetanus toxoid should be injected intramuscularly into the deltoid
muscle in women and older children. If there are indications for
the use of tetanus toxoid in younger children the preferred site
for intramuscular injection is the anterolateral aspect of the upper
thigh since it provides the largest muscular area.
Only sterile needles and syringes should be used for each injection.
The vaccine should be well shaken before use.
Each injection of the primary immunization series should be made
into a different site.
Mild local reactions consisting of pain, erythema, tenderness and
induration at the injection site are common and may be associated
with systemic reactions including mild to moderate transient fever
Persistent nodules at the site of injection have occurred following
the use of an adsorbed vaccine, but this complication is unusual.
Sii Tetanus Toxoid (Adsorbed) should not be administered to infants
or children with high fever, or other evidence of acute illness.
The specific contraindications adopted by individual national health
authorities should reflect a balance between the risk from the vaccine
and the risk from the disease. Because the risk from the vaccine
remains extremely low in comparison to the risk from the disease
in many developing countries, authorities there may choose to offer
immunization to children who are mildly to moderately ill or malnourished.
PRECAUTIONS AND WARNINGS
Individuals receiving corticosteroids or other immunosuppressive
drugs may not develop an optimum immunologic response. The possibility
of allergic reactions in individuals sensitive to the component
of the product should be borne in mind. A separate sterile syringe
should be used for each individual patient to prevent the transmission
of hepatitis or other infectious agents.
WITHDRAWING THE VACCINE FROM A SEALED GLASS AMPOULE
Shake the ampoule to disperse the contents thoroughly immediately
before withdrawing the dose.Tap the ampoule to ensure that the solution
is in the lower portion rather than in the neck of the ampoule Wipe
the neck of the ampoule with a suitable antiseptic using a sterile
piece of cotton break off the top of the ampoule at the constriction
by thumb pressure.
WITHDRAWING THE VACCINE FROM A RUBBER-STOPPERED VIAL
DO NOT REMOVE THE RUBBER STOPPER FROM THE VIAL
Shake the vial to disperse the contents thoroughly immediately before
each withdrawal of vaccine. Apply a sterile piece of cotton moistened
with a suitable antiseptic to the surface of the rubber stopper
and allow to dry. Draw into the sterile syringe a volume of air
equal to the amount of vaccine to be withdrawn from the vial. Pierce
the centre of the rubber stopper with the sterile needle of the
syringe, invert the vial, slowly inject into it the air contained
in the syringe, and keeping the point of the needle immersed. withdraw
into the syringe the required amount of vaccine. Then hold the syringe
plunger steady and withdraw the needle from the vial.
Carefully insert the needle intramuscularly at the prepared injection
site. In order to avoid intravenous injection, pull back the plunger
of the syringe to make certain that no blood is withdrawn before
injecting the desired dose.
Sii Tetanus Toxoid (Adsorbed) should be stored between 2°C and
8°C (35° and 46°F).
NOT TO BE FROZEN.
Product which has been exposed to freezing should not be used.
Sii Tetanus Toxoid (Adsorbed) is supplied, ready to use, in rubber-stoppered
multi-dose vials, and in single-dose glass ampoules in the following
i) 0.5 ml. X 10 ampoules box.
ii) 0.5 ml. X 50 ampoules box.
iii) 5 ml. - 10 dose X 50 vials box.