BIOLOGICAL PRODUCTION DIVISION

NATIONAL INSTITUTE OF HEALTH

ISLAMABAD-PAKISTAN

FOR THE REGISTERED MEDICAL PRACTITIONERS

TETANUS TOXOID ADSORBED

Meets WHO Requirements

Composition:
One dose (0.5ml) of Tetanus Toxoid contains:
Active constituent: Purified and adsorbed tetanus antigen ::_40IU.
• Exclplents: Merthiolate not more than 0.01%, Aluminium contents not more
than 1.25 mg, IM'I q. s.
Properties / Effects:
Tetanus is caused by the action of C/ostr1diumtelani toxin upon the central nervous system.
The toxin increases reflex stimulation of the motor neurons by functional blockade of the
inhibitory neurons. This leads to the typicaltelanus symptoms of rigidity and reflex spasms.
For active immunization, the tetanus toxin is converted into a non-toxic toxoid which remains
,/ fully effective as an antigen. The active potentialis increased by adsorption onto an aluminium
adjuvant.
Indications/Possible Application:
Active immunization againsttetanus.
Dosage/Administration:
0.5 mllntramuscularinjection at any age,
Active Immunization:
Three doses of 0.5ml each, the first two doses are to be given 4-8 weeks apart with a third
dose 6 to 12 months later. To maintain the level of immunity, further 0.5ml booster dose is
recommended every 5to 10years.
Tetanus Prophylaxis In Case of Injury:
Previously immunized individuals:
If tetanus vaccination was performed one year or less before present injury,
prophylaxis is not necessary'.

'
If tetanus vaccination was performed one to five years previously, a booster dose Of
O.Smlmust be given .
... If vaccination was performed more than five years before, it is
necessary to give a booster dose of O.Smltetanus toxoid alongwith an in'jection of
1500 IU.tetanus antiserum (ATS).
Unimmunlzedindividuals:

~.-
I If vaccination was not carried out or was incomplete, 1500 IU tetanus antiserum is
recommended alongwith a complete course of tetanus vacclnatlon.
Neonatal tetanus prevention:
A oreviousty un-immunized pregnant woman who might deliver her child under non-hyqientc
~~arn:es snourorecervearrammum-cttwo-ccsesof feranus TOXOIO Acsoroeo spaeee 4-
8 weeks apart. This should be carried out before delivery, preferably during the first two
trimesters.
Incompletely immunized pregnant women should complete the three dose series. Those
immunized more than 10 years previously should have a booster dose. Immunization is not
effecacious for the fetus if administeredlaterthan 2 weeks priorto deiivery.
Contra indications:
In case of injury,there are no absolute contraindications.In case of known hypersensitivity to
tne vaccine, it should be considered whether an exclusively passive immunizations should be
conducted.
Precautions:
• The vaccine should be postponed in patients wrth acute febrile illness, in so far as the
indication is not urgent
• In case of possible sensitivity, review of the patient history and availability of antiallergic
substance to combat any immediateallergicreaction is required.
Pregnancy/Lactation:
• Tetanus vaccination in a pregnant woman who has not previously been vaccinated. or
who has been incompletelyvaccinated, is recommended.
.. Tetanus vaccination during nursinghas no negativeeffect on the child.
Adverse Reactions:
Local reactions such as pain, reddening, swelling and indurations at the injection site may
occurS to 24 hours after injection.They are generallymild and last for 1to 3 days. Treatment is
given accordlng to the symptoms. More pronouncedreaction in adult is mostly the result of a
high·level immunity still being present atthe time of inoculation.
lnteracnons:
Tetanus Toxoid Adsorbed can be administered simultaneously or at any interval between a
different vaccine. If vaccination is necessaryduring immunosuppressive therapy, the immune
response should be controlled serologically.
Overdosage:
Not known to date.
Further Information:
Storage and shelf life:
Store between +2 to +8'C, protect from light, do not freeze and do not use inadvertently frozen
vaccine. AHhoughthe vaccine remains stable,for reasons of sterility, opened vials should be
used on the same day.
expiry Date:
Every packing shows an expiry date:the productshouidnot be used after this date.
Shake well before use:
Keep out of reach of children:
Packing:
100 vists of 5 mi. Manufactured By:
Biological Production DIvision
National Institute of Health
Islamabad·PAKISTAN
Phone NO.051·9255110-14
Fax No.9255099
Email:bpdnih~comsats.net.pk
Mfg Lic. No. 000092
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