For The Use Of Registered Medical Practioner Or Hospital Or Laboratory Only

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Abhay RIG PRODUCT

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Rabies Antiserum I.P

COMPOSITION and vaccine. Anti rabies vaccine should be inoculated in different parts of the body
Each vial contains contra-laterally if possible. In this case interference is minimized. AbhayRIG should
Equine antirabies immunoglobulin fragments not less than 300 I.U/ml. not be administered in the same syringe as the vaccine.
Cresol I.P = 0.25% v/v as a preservative
Glycine I.P --------------------------------------------------------- 0.0225 g/ml PREGNANCY AND LACTATION
Sodium Chloride I.P -------------------------------------------- 0.009 g/ml The safety of AbhayRIG when used during pregnancy has not been established in
Water For Injection I.P ----------------------------------------- q.s clinical trials in human beings. Considering the lethal risk associated with rabies,
Pregnancy is not a contraindication to the administration of AbhayRIG subsequent to
PHARMACEUTICAL FORM exposure to rabid animal.
Solution for injection by intramusclar route 5 ml vial, 1500 IU
Table: Guide for Post Exposure Treatment
THERAPEUTIC INDICATION
AbhayRIG provides passive immunization against rabies. AbhayRIG is indicated for Category Type of contact with the Recommended Treatment
the prevention of rabies in patients at risk of being exposed to rabies after contact with suspected or confirmed
a rabid animal or an animal presumed to be rabid. domestic or wild animals or
AbhayRIG itself does not constitute an antirabies treatment and should always be Animals unavailable for
observations
used in conjuction with rabies vaccine.
I Touching or feeding of animal, None, if reliable case
CONTRAINDICATIONS licks on intact skin history available
Should be used with extreme caution in subject with a history of allergic symptoms or
hypersensitivity to horse serum. In case of doubt, it is essential to ask your doctor or II Nibbling of uncovered skin, Administer vaccine immediately. Stop the
pharmacist for advise. minor scratches or abrasion treatment if the animal remains healthy
without bleeding, licks for a period of 10 days** or has been
SPECIAL WARNINGS AND PRECAUTIONS FOR USE on broken skin killed humanely and found to be negative
Despite the high degree of purification of the serum. It is recommended to perform a for Rabies by appropriate laboratory
skin test before administering heterologous serum. The skin test consists of intradermal techniques.
injection of 0.1 ml of 1:10 dilution of AbhayRIG on the outside of the forearm so as to III Single or Multiple transdermal Administer rabies immunoglobulins and
obtain an orange ring type appearance (3 mm diameter in duration). An equivalent bites or scratches with saliva vaccine immediately. ** Stop treatment
intradermal injection of physiological saline solution is used as control The observations (i.e.licks) if the animal remains healthy throughout
made 15 minutes after intradermal injection is considered to be positive if erythema the observation period of 10 days***
(>6mm), local oedema or a systemic reaction is observed and the control is negative. or if animal is euthanised and found
A positive test result is not a formal contraindication for the use of seropathy, but it to be negative for rabies by appropriate
should be considered as a warning. A negative test is not an absolute guarantee for laboratory techniques.
the absence of an immediate allergic type reaction.
** If an apparently healthy dog or cat in or from a low risk area is placed under
DRUG INTERACTIONS observation it may be justified to delay specific treatment.
*** This observation applies only to dogs and cats.
Rabies prevention requires simultaneous administration of antirabies immunoglobulin
Continued

IMPORTANT NOTES
ACTION
Washing the wound copiously
with soap and water
Application of 70% alcohol,
tincture of iodine, povidine
iodine or any other suitable
disinfectant (after all traces of
soap have been removed)
Proper infiltration of the wound
with rabies immunoglobulin (RIG)
of Human or Equine orign. As
much as anatomically feasible
should be infiltrated into and
around the wound and the
remaining. If any to be injected
(by intramuscular route only) in
the deltoid region away from
the site of vaccine
administration
Administration of potent cell
culture vaccine as per
recognized schedules
RESULTS
Helps reduce the viral load
by physically removing virus particles
(with running water) and subsequently by
inactivating some of the remaining virions by
chemical disruption. This simple action,
if promptly carried out, can significantly
reduce the risk of developing rabies.
Alcohol or other disinfectants
lead to further inactivation
of the remaining virions by
chemical disruption.
RIG is a specific-rabies-virus-neutralising
antibody that immediately neutralizes
the rabies virus on contact. Once
the viruses are coated with antibody.
They can not absorb onto and enter
the nerve endings. This results in a further
reduction (and in some cases complete
obliteration) of the inoculated virus.
Even in deeper tissues where the
soap or alcohol may not have reached.
Potent cell culture vaccine when
administered according to the approved
schedules results in the systemic production
of anti-rabies antibodies after a lag period of
7 to 14 days. These circulating antibodies
reach the wound site through the systemic
circulation and are able to neutralize
any remaining virus particles.
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FIRST-AID TREATMENT
All the areas of the site of the bite or scratch site which may be infected with rabies
virus should be immediately and thoroughly washed with soap or detergent with running
water and 70% alcohol or an iodine preparation is applied AbhayRIG should be injected
as soon as possible in case of suspected exposure.
DOSAGE AND ADMINISYTRATION OF AbhayRIG
For the prevention of rabies, combined immunoglobulin and rabies vaccine treatment
is recommended for all category III exposure as per WHO classification of exposure.
The recommended dose of AbhayRIG is 40IU/Kg of the body weight, if anatomically
feasible, as much as possible of the dose should be infiltrated around the wounds.
Administer the remainder of the dose, if any by deep intramuscular injection at a site
separate from that used for the vaccine. Ensure that the wound has been adequately
infiltrated with immunoglobulin locally before suturing, if suturing is necessary. The
first dose of the vaccine should be inoculated at the same time as that of AbhayRIG,
but at a different site on the body. In no cases should the dosage of AbhayRIG be
exceeded because immunoglobulin may partially suppress active production of
antibodies. Children and adults receive the same dose of 40 IU/Kg of body weight. In
case the volume of AbhayRIG is low or insufficient for infiltration in case of child or in
case of large bite site then it can be diluted in normal saline. When indicated, begin
anti tetanus treatment and administer anti microbial drugs to control infections other
than rabies. Discard any unused portion.
UNDESIRABLE EFFECTS
Immediate or delayed hypersensitive type reactions may be developed on
administration of AbhayRIG. The observed immediate reactions are anaphylactoid
reactions with hypertension, dyspnoea and urticaria. Delayed reactions consist of
inflammatory reaction, fever, pruritis, rash or urticaria, adenopathy and arthralagia.
Inform your doctor or pharmacist if you experience any undesirable effect.
STORAGE CONDITIONS
Store at a temperature between 2oC and 8oC in a refrigerator. DO NOT FREEZE.
PRESENTATION
Vials of 5 ml. Each vial contains not less than 1500 IU of equine antirabies
Immunoglobulin.
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