DESCRIPTION
Tetanus Antitoxin B.P. is a sterile proteolytically refined
solution of globulins. It is prepared from serum obtained
from equines, hyperimmunised with tetanus toxoid and toxin.
It contains 
0.25% phenol as a preservative. Antitoxin
can be used both for prophylaxis and treatment of Tetanus.
DOSAGE AND ADMINISTRATION
Prophylactic use:
Tetanus antitoxin is to be given prophylactically to persons
at risk with infected wounds, wounds contaminated with soil
or mud, deep or punctured wounds and wounds with devitalising
tissue damages. A dose of 1,500 IU should be given subcutaneously
or intramuscularly as early as possible after the wound
is received. In severe wounds, the dose may be doubled or
tripled and the antitoxin injected in two or three places
around the wound. Prophylactic use is also to be recommended
in case of surgical operations involving reopening of old
scars, piles, and fistuale and those in which faecal contamination
is likely.
Along with prophylactic passive immunisation, it is advisable
to initiate active immunisation with adsorbed Tetanus toxoid.
Therapeutic use:
For therapy, large doses 100,000 - 200,000 IU of antitoxin
should be given very slowly by intravenous route followed
by smaller weekly doses intramuscularly as required. Some
physicians prefer a smaller initial dose of 20,000 IU or
so intramuscularly. Active immunisation may be initiated
when the patient is cured of the illness.
ADVERSE EFFECTS AND PRECAUTIONS
Allergic Reactions:
In all cases, whether for propylactic or therapeutic use,
due precautions must be taken against possible allergic
reactions as some individuals are likely to be sensitive
to equine serum.
Although modern methods of refining the serum have reduced
the incidence of allergic reactions a small percentage of
persons who receive injections of foreign serum still develop
such reactions. The reactions may develop within a few minutes
of administration of serum or may take from a few hours
to 10-12 days. The reaction is in most cases mild and evidenced
by development of rashes like urticarial rash, itching,
joint pains, slight oedema and varying degrees of local
glandular swelling. The illness is seldom serious and rarely
fatal.
In a very small minority of cases, however, a severe shock
resembling an anaphylactic shock develops within a few minutes
of administration of serum, and some of these cases, if
not immediately and properly treated, may prove fatal. Amongst
the immediate reactors there is often evidence of previous
treatment with equine serum. Before giving the serum, therefore,
it is always necessary to go into the previous history of
the presence of allergic diseases like asthma, eczema, hayfever,
etc., and also into the history of previous treatment with
equine sera. Such patients should be treated with extreme
care and caution.
In the case of all patients receiving Tetanus antitoxin
serum, it is absolutely essential to test for hypersensitivity
of the individual with a test dose.
The test dose should be administered with a small amount
of the serum (0.2 ml of 1:10 dil.) either by subcutaneous
or intra-cutaneous injection, If reaction develops within
a few minutes indicating the existence of hypersensitivity,
the serum should be given with great caution in small divided
doses subcutaneously at regular intervals of half an hour.
Intravenous administration of serum is not recommended in
hypersensitive case.
In all cases receiving serum, the patient must be observed
for an hour after the administration of serum, and Adrenaline
injection (1: 1 000) must be kept ready at hand for immediate
treatment of shock if it develops.
STORAGE
To be stored in the dark between 2° C to 8° C.
DO NOT FREEZE.
PRESENTATION
1,500 IU in 1.0 ml. x 50 ampoules carton.
3,000 IU in 2ml x 20 vials carton.
3,000 IU in 1ml x 20 ampoules carton.
6,000 IU in 2ml x 20 vials carton.
10,000 IU in 3.33 ml. single vial carton.
20,000 IU in 5.0 ml. single vial carton.
50,000 IU in 12.5 ml. single vial carton.
