Rabies vaccine U.S.P. (Adsorbed) SII RABIVAX® 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 rabies
- Personnel in abattoirs and knackers yards, taxidermists, animalists.
- Farmers, gamekeepers and forestry workers in enzootic areas and
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 also occur.
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
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
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
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.
SII RABIVAX® is available as
ampoule / vial containing
1 ml - 1 dose carton plus sterile disposable syringe and needle.
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
Type 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
Administer 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)
|Administer rabies 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 treatment.
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