Rabies Vaccine (Adsorbed) SII RABIVAX®
is a 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 b -
propiolactone. After inactivation the virus is adsorbed onto
aluminium phosphate. The vaccine has the appearance of a pale
yellow to light pink colour. The vaccine meets the requirements
of WHO when tested by the methods outlined in WHO, TRS 941
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 had 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 risk 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
Do not administer vaccine by intravascular route.
Ensure that the needle does not enter a blood vessel.
Immunoglobulins and rabies vaccine should not be combined in
the same syringe or injected at the same site.
Radiation therapy, antimalarials, corticosteroids, other
immunosuppressive agents and immunosuppressive illnesses can
interfere with the development of active immunity after
vaccination, and may diminish the protective efficacy of the
vaccine. Pre-exposure vaccination should be administered to
such persons with the awareness that the immune response may
be inadequate. Immunosuppressive agents should not be
administered during post-exposure therapy unless essential for
the treatment of other conditions. When rabies post-exposure
prophylaxis is administered to persons receiving
corticosteroids or other immunosuppressive therapy, or who are
immunosuppressed, it is important that a serum sample on day
14 (the day of the fourth vaccination) be tested for rabies
antibody to ensure that an acceptable antibody response has
With HDC the risk of side effects are lower. However, some
possible side effects are :
Local minor reactions like : Redness, induration and swelling
may occur which subside within 24 to 48 hours. Fever may occur
in some cases. Occasionally rare side effects like arthralgia,
myalgia, headache/dizziness,nausea, GI disorders may occur.
DOSAGE AND ADMINISTRATION
In adults, administer Rabies vaccine by IM injection into
the deltoid muscle. In small children and infants, administer
vaccine into the anterolateral zone of the thigh. The gluteal
area should be avoided for vaccine injections, since
administration in this area may result in lower neutralizing
The vaccine vial should be well shaken before use. The dosage
is 1 ml for adults and children.
Do not inject intravascularly.
The vaccine vial monitor (VVM), if attached, has not reached
the discard point (see figure).
The vaccine should be visually inspected for any foreign
particulate matter and / or variation of physical aspect prior
to administration. In event of either being observed, discard
A. PRE-EXPOSURE IMMUNIZATION:
Pre-exposure prophylaxis consists of 3 intramuscular
doses of 1 ml to be given on days 0, 7 and 21 or 28. For
adults and children aged
2 years, the vaccine should always be administered in the
deltoid area of the arm; for children aged
< 2 years, the anterolateral area
of the thigh is recommended.
W.H.O. recommends persons at a permanent risk, diagnostic
research and production laboratory staff working with rabies
virus, must be vaccinated. A serological test every six months
is recommended. A booster injection should be administered
when the anti body titre falls below the limit considered to
be protective: 0.5 IU per ml by RFFIT. Periodic booster
injections are recommended as an extra precaution only for
people whose occupation puts them at continual or frequent
risk of exposure. If available, antibody monitoring of
personnel at risk is preferred to the administration of
routine boosters. For people who are potentially at risk of
laboratory exposure to high concentrations of live rabies
virus, antibody testing should be done every 6 months. Those
professionals who are not at continual risk of exposure
through their activities, such as certain categories of
veterinarians and animal health officers, should have
serological monitoring every 2 years. Because vaccine-induced
immunity persists in most cases for years, a booster would be
recommended only if rabies virus neutralizing antibody titres
fall to < 0.5 IU/ml. Considering the satisfactory antibody
titres observed with SII RABIVAX®,
if serological tests cannot be conducted due to cost
considerations or inaccessible medical facilities, a booster
dose one year after primary immunization followed by the one
dose every 5 years would be advisable.
B. POST EXPOSURE IMMUNIZATION:
The essential components of rabies post-exposure
prophylaxis are prompt local treatment of wounds and
administration of both Human Rabies Immune Globulin (HRIG) and
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
litre) or tincture or povidone iodine.
A full post-exposure regime is indicated if vaccination was
not documented or incomplete or if the last booster dates over
5 years. According to the degree and severity of bite, in
cases of severe bites (class III WHO category), 20 I.U./kg
body weight of specific rabies immunoglobulin of human origin
(HRIG) or 40 IU per kg body weight of equine rabies
immunoglobulin (ERIG) should be given after a sensitivity test
in conjunction with vaccine on day 0. If rabies immunoglobulin
is not available at the time of the first dose of the vaccine,
it must be administered not later than 7 days after the first
vaccination. The dose of rabies immunoglobulin should not
exceed the recommended dose.
If anatomically feasible, the FULL DOSE of HRIG should be
thoroughly infiltrated in the area around and into the wounds.
Any remaining volume of HRIG should be injected IM at a site
distant from rabies vaccine administration. HRIG should never
be administered in the same syringe or in the same anatomical
site as the rabies vaccine.
1) Unimmunized or incompletely immunized individuals:
The post-exposure vaccination schedule consists of injecting 1
ml into the deltoid muscle (or anterolateral thigh in children
aged < 2 years) of patients with category II and III
exposures. The recommended regimen consists of a 5-dose
1 dose on each of days 0, 3, 7, 14 and 28;
2) Previously fully immunized individuals:
In those previously immunized by complete preventive
vaccination (pre-exposure vaccination or post-exposure
treatment): 2 doses of 1 ml given by intramuscular route one
each on day 0 and day 3 are recommended. No HRIG should be
administered to previously vaccinated persons as it may blunt
their rapid memory response to rabies antigen.
3) Immunocompromised individuals:
Patients receiving immunosuppressive therapy, or who have
congenital or acquired immunodeficiency, should be vaccinated
once on each of the days 0, 3, 7, 14, 28. In addition, the
initial immunisation dose (day 0) should be doubled with a
single dose of vaccine being administered as soon as possible
after exposure into each of the right and left deltoid muscles
(upper-arm muscle) or, in small children, into the
anterolateral region of each of the right and left thighs.
If immunocompromised patients (with impaired defence system )
are treated after exposure to rabies, it is advisable that the
antibody titre be measured 14 days after the first dose. If a
titre of at least 0.5 IU/ml, which is considered adequate to
confer protection, is not present, a dose of vaccine should be
immediately administered into each upper-arm (or into each
thigh in the case of small children). Depending on the
immunisation status of these patients, additional doses may be
necessary to achieve appropriate antibody titres in serum.
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 ampoules / vials 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 ampoules/vials carton
1 ml x 50 ampoules carton
THE VACCINE VIAL MONITOR (Optional)
Inner square lighter than outer
If the expiry date has not passed, USE the vaccine.
At a later time, inner square still lighter than
If the expiry date has not passed, USE the vaccine.
Inner square matches colour of outer circle.
DO NOT use the vaccine.
Beyond the discard point:
Inner square darker than outer ring.
DO NOT use the vaccine.
Vaccine Vial Monitors (VVMs) are part of the label on
Rabies Vaccine supplied through Serum Institute of India Ltd.
The colour dot which appears on the label of the vial is a VVM.
This is a time-temperature sensitive dot that provides an
indication of the cumulative heat to which the vial has been
exposed. It warns the end user when exposure to heat is likely
to have degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central
square. Its colour will change progressively. As long as the
colour of this square is lighter than the colour of the ring,
then the vaccine can be used. As soon as the colour of the
central square is the same colour as the ring or of a darker
colour than the ring, then the vial should be discarded.
WHO GUIDE FOR POST EXPOSURE TREATMENT
of contact with a suspect or confirmed rabid domestic
or wild animal, or animal unavailable for observation.
|Touching or feeding of animals.
Licks on intact skin
|None, if reliable
case history is available
Nibbling of uncovered skin. Minor scratches or abrasions
Administer vaccine immediately.
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.
Licks on broken skin
or multiple transdermal bites or scratches
of mucous membrane with Saliva (i.e. licks)
rabies immunoglobulin and vaccine immediately.
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.