Rabies vaccine U.S.P. (Adsorbed) is a single sterile, cell
culture derived rabies vaccine for pre-and post-exposure prophylaxis
in humans. It is prepared with Pitman-Moore strain of rabies
virus. The virus is propagated on human diploid cells. The
virus is inactivated with ß propiolactone. After inactivation
the virus is adsorbed onto aluminum phosphate.
Rabies virus (Pitman-Moore strain) adapted, grown on human
diploid cells and inactivated by ß using propiolactone.
Each dose of 1 ml contains:
Potency of Rabies antigen > 2.5 I.U.
Adsorbed onto aluminum Phosphate.
Al+++ not more than 1.25 mg
Preservative: Thiomersal 0.01 %
Dose: 1 ml by intramuscular injection
A. Rabies prevention in subjects exposed to a risk of contamination
This vaccination is particularly recommended for:
- Professional groups exposed to frequent contaminations.
- Veterinary surgeons including students at veterinary colleges.
- Technical personnel handling material contaminated with
- Personnel in abattoirs and knackers yards, taxidermists,
- Farmers, gamekeepers and forestry workers in enzootic areas
B. Treatment after certain or plausible rabies contamination
- Treatment of subjects bitten by rabid animals or those suspected
of being so.
- Treatment of contact subject.
Rabies vaccine adsorbed is contraindicated in persons who
have life threatening allergic reactions to previous injections
of this vaccine or to components of this vaccine including
thiomersal. When pre-exposure treatment is given, vaccination
can be postponed in high fever, acute or chronic disease.
In pregnancy benefit ratio should be assessed and vaccine
can be deferred. When post-exposure treatment is given due
to fatal course of rabies, pregnancy is not a contraindication.
In case of serious contamination, it is recommended by the
World Health Organisation that a treatment of 20 I.U. per kg
of specific human rabies immune globulin or 40 I.U per kg
of purified rabies serum of animal origin, be started in conjunction
on the first day of vaccination (DO). In subjects who have
received preventive vaccination within a period of one year
and who can prove by a vaccination certificate, it is recommended
that 2 0r 3 immunising doses be given according to the severity
of the bite.
Do not administer vaccine by intravascular route.
The corticosteroids and immunosuppressive treatment may
lead to vaccination failure. In these cases, a titration of
neutralizing antibodies should be performed.
Local minor reactions like: Redness and slight induration
at the injection site, lasting 24 to 48 hours. Rare febrile
reactions nausea, headache, fever, malaise or myalgia may
More marked local reactions and swelling are possible. More
marked local reactions, an increase in body temperature over
38° C, lymph node swelling, arthritis and gastro intestinal
disorders may occasionally occur.
DOSAGE AND ADMINISTRATION
Rabies vaccine should be injected intramuscularly into the
deltoid muscle in adults. In children the anterolateral aspect
of the thigh is an acceptable injection site. The vaccine
should not be given in the gluteal region. The vaccine vial
should be well shaken before use.
A. PRE-EXPOSURE IMMUNIZATION:
3 injections of 1 ml by intramuscular
route on D0, D7, D28, booster injection 1 year later. Injection
can also be given on day 21.Booster injections every 5 years.
For countries which follow the WHO recommendations: 3 injections
of rabies vaccine of potency at least 2.5 I.U. given on days
D0, D7, D28 (a few days variation is not important), booster
injection every 1 year later.
B. POST EXPOSURE IMMUNIZATION:
In subjects unvaccinated against
rabies, the treatment consists of 5 x 1 ml injections by the
intramuscular route on days D0, D3, D7, D14, D28 after contact
with an animal who is rabid or suspected of being so. A booster
dose on D 90 is optional.
In those previously immunized by complete preventive vaccine:
2 booster injections of 1 ml given by intramuscular route
on day 0 and day 3.
According to the degree and severity of the bite, in cases
of severe bites, 20 I.U. per kg body weight of specific rabies
immunoglobulin of human origin (HRG) or 40 I.U. per kg body
weight of purified rabies, immunoglobulin of equine origin
(ERIG) should be given in conjunction on D0, which will provide
protective antibodies immediately.
A. Local treatment of wounds involving possible exposure to
rabies recommended in all exposures.
First aid or local treatment consists of immediate thorough
flushing and washing of the wound with water or soap and water
followed by the application of 70% alcohol (700 ml per liter)
or tincture or povidone iodine. Medical care may then consist
of the instillation of a rabies immunoglobulin (after skin
testing, if necessary) into the depth of the wound should
not be sutured, but if suturing is necessary then it is essential
that it be preceded by the administration of rabies immunoglobulin
(antiserum) as above.
The vaccine should be stored between 2° C and 8° C.
Do not freeze. Discard if the product has been frozen.
Rabies Vaccine is available
as ampoule / vial containing
1 ml - 1 dose carton plus sterile disposable syringe and
1 ml x 5 vials carton
1 ml x 5 ampoules carton
1 ml x 50 vials carton
1 ml x 50 ampoules carton
GUIDE FOR POST EXPOSURE TREATMENT
of contact with a suspect or confirmed rabid domestic
or wild (a) animal, or animal unavailable for observation.
|Touching or feeding of animals.
Licks on intact skin
||None, if reliable
case History is available
of uncovered skin. Minor scratches or abrasions without
bleeding licks on broken skin
vaccine immediately (b). Stop treatment if animal remains
healthy throughout an observation period of 10 days
or if animal is killed humanely and found to be negative
for rabies by appropriate laboratory techniques.
or multiple transdermal bites or scratches contamination
of mucous membrane with Saliva (i.e. licks)
immunoglobulin and vaccine immediately (b). Stop treatment
if animal remains healthy Throughout an observation period (c)
of 10 days or if animal is killed humanely And found to
be negative For rabies by appropriate laboratory techniques.
a. Exposure to rodents,
rabbits and hares seldom, if ever requires specific anti-rabies
b. If an
apparently healthy dog or cat in or from a low risk area is
placed under observation, the situation may warrant delaying
initiation of treatment.
c. This observation period
applies only to dogs and cats. Except in the case of threatened
endangered species, other domestic and wild animals suspected
as rabid should be killed humanely and their tissues examined
using appropriate laboratory techniques.