Human
Health > Anti Rabies
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Rabies
Antiserum I.P |
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COMPOSITION:
Each 5 ml vial contains:
Equine anti rabies immunoglobulin fragments ……….. Not less than 1500 IU.
Chloro-m-Cresol I.P........................................... Not more than 0.25%v/v.
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PHARMACEUTICAL FORM
Solution for injection by intramuscular or subcutaneous route 5ml vial, 1500IU
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THERAPEUTIC INDICATIONS:
AbhayRIG provides passive immunization against rabies. AbhayRIG is for
prevention of rabies in patients at risk of being exposed to rabies after contact with a rabid animal or an animal presumed to be rabid.
AbhayRIG itself does not constitute an anti rabies treatment and should always be used in conjunction with
rabies vaccine.
CONTRA-INDICATIONS:
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 pharmacist for advice.
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SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Despite the high degree of purification of the serum, it is recommended to
perform a skin test before administering heterologus serum.
The skin test consists of a intradermal injection of 0.1ml of 1:10 dilution of AbhayRIG on the outside of the forearm so as to obtain an orange ring type
appearance (3 mm diameter induration). An equivalent intradermal injection of physiological saline solution is used as control. The observations made 15
minutes after intradermal injection is considered to be positive if erythrema
(>6mm), local oedema or a systemic reaction is observed and the control is
negative.
A positve test result is not a formal contra-indication for the use of
serotherapy, but it should be considered as a warning.
A negative test is not an absolute guarantee for the absence of an immediate allergic type reaction.
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DRUG INTERACTIONS:
Rabies prevention requires simultaneous administration of antirabies immunoglobulin and vaccine. Anti
rabies vaccine should be inoculated in different parts of the body contra-laterally if possible. In this case
interference is minimized.
AbhayRIG should not be administered in the same syringe as the vaccine.
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PREGNANCY AND LACTATION:
The safety of AbhayRIG when used during pregnancy has not been
established in clinical trials in human beings. Considering the lethal risk
associated with rabies, pregnancy is not a contra-indication to the
administration of antirabies treatment subsequent to exposure to rabid animal.
Table : Guide for Post Exposure Treatment ( WHO recommendation for post exposure treatment
|
Category |
Type
of contact with suspected or confirmed
domestic or wild animals or animals
unavailable for observation |
Recommended
treatment |
|
I |
Touching
or feeding of animals Licks on intact
skin |
None,
if reliable case history is available |
|
II |
Touching
or feeding of animals Licks on intact
skin |
Administer
vaccine immediately
Stop treatment if animal remains healthy
throughout an observation period of 10
days/**
Or,
if the animal is euthanised and found to
be negative for rabies by appropriate
laboratory technique |
|
III |
Single
or multiple transdermal bites or
scratches Contamination of mucous
membrane with saliva (i.e. licks) |
Administer
rabies immunoglobulin and vaccine
immediately**
Stop
treatment if animal remains healthy
throughout an observation period of 10
days,***
Or, if the animal is euthanised and
found to be negative for rabies by
appropriate laboratory technique. |
** If an
apparently healthy dog or cat in or from a low
risk area is placed under observation it may
be justified to delay specific treatment
*** This observation applies only to dogs and cats
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IMPORTANT
NOTES:
| Action |
Results |
| Washing
the wound copiously with soap and water |
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 |
| Application
of 70% alcohol, tincture of Iodine,
povidine iodine or any other suitable
disinfectant (after all traces of soap
have been removed) |
Alcohol
or other disinfectants lead to further
inactivation of the remaining virions by
chemical disruption |
| Proper
infiltration of the wound with Rabies
Immunoglobulin (RIG) of Human or Equine
origin. 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. |
RIG
is a specific rabies-virus-neutralising
antibody that immediately neutralizes
the rabies virus on contact. Once the
viruses are coated with antibody, they
cannot adsorb 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. |
| Administration
of a potent cell culture vaccine as per
the recognized Schedules |
Potent
cell culture vaccines when administered
according to the approved schedules
result in 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 body and 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.
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DOSAGE AND ADMINISTRATION OF ABHAYRIG:
For 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 40 IU/Kg. of body weight infiltrated in and around the wound as much as anatomically feasible. 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.
Incase the volume of AbhayRIG is low or insufficient for infiltration in case of a child or in case of large bite site then it can be diluted in normal saline.When indicated, begin anti-tetanus treatment and administer antimicrobial drugs to control infections other than rabies.
Discard any unused portion.
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UNDESIRABLE EFFECTS:
Immediate or delayed hypersensitive type reactions may be developed on
administration of AbhayRIG. The observed immediate reactions are
anaphylactoid reactions with hypotension, dyspnea, 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.
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STORAGE CONDITIONS :
Store at a temperature between 2*C and 8*C in a refrigerator.
DO NOT FREEZE.
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PRESENTATION :
Vials of 5 ml, Each vial contains 300IU/ml of equine anti-rabies
immunoglobulin.
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