Anti Rabies Serum (ARS)

1. DESCRIPTION:
   Rabies Antiserum is a preparation containing the specific globulin obtained by purification of hyper-immune serum/plasma of healthy equines having specific activity of neutralizing the rabies virus and phenol as preservative.
2. COMPOSITION:
   Each ml of serum contains:
   - Enzyme refined Equine globulin  300 IU
   - Preservative, Phenol  0.25%
3. STORAGE:
   2 - 8⁰C in dark and should not be allowed to freeze.
4. EXPIRY:
   24 months.
5. TREATMENT / INDICATIONS:
   Anti Rabies serum is used to provide passive immunity against rabies in post-exposure prophylaxis of individuals, exposed to the disease or virus after contact with a rabid animal or an animal presumed to be rabid. Anti rabies serum itself does not constitute an anti rabies treatment and should always be used in conjunction with rabies vaccine.

   For the treatment of bites as based on WHO recommendations

   Class	Type of contact	Level of Exposure	Recommended post exposure prophylaxis
   I	- Touching or feeding animals, - Licks on the skin	None	None if reliable case history is available
   II	- Nibbling of uncovered skin, - Minor scratches or abrasions without bleeding, - Licks on broken skin	Minor	- Wound management - Anti rabies vaccine
   III	- Single or multiple transdermal bites or scratches, - Contamination of mucous membrane with saliva from licks, - Suspect contact with bats	Severe	- Wound management - Anti rabies vaccine - Rabies immunoglobulin

6. PRECAUTIONS :
   • Shake well, withdraw the contents aseptically from the vial
   • Do not freeze the contents of the vial
   • Protect the vaccine vial from light
   • Separate sterile syringe should be used for each individual.
   • Allergic reactions with component of product should be borne in mind therefore ‘Sensitivity test’ is recommended. This test is to be performed prior to the administration of ERIG as follows:
     • Inject 0.1ml of ERIG diluted in 1 in 10 in “sterile water for injection (WFI) I.P.” intradermally into the flexor surface of the forearm to raise a bulb of about 3-4mm in diameter.
     • Inject an equal amount of “sterile water for injection (WFI) I.P.” as a negative control on the flexor surface of the other arm.
     • After 15 minutes an increase in diameter to more than 10mm of induration surrounded by flare is taken as positive skin test, provided the reaction on the water for injection test is negative.
     • An increase or abrupt fall in blood pressure, syncope, hurried breathing, palpitation and any other systemic manifestations should be also taken as a positive test.
     • In case of negative skin test, the treatment may be started.
     • In case of positive test, use of Human Rabies Immunoglobulin (HRIG) is recommended.
   • To minimize interaction, rabies Immunoglobulin and rabies vaccine shall be injected to different parts of body.
7. POSOLOGY AND ADMINISTRATION:
   DOSE - 40 I.U./Kg body weight upto a maximum of 3000 I.U.
   - As much of the calculated dose should be infiltrated into and around the wound as is anatomically   feasible.
   - Remaining immunoglobulin, if any, should be administered intramuscularly.
   - If the calculated dose of the antiserum is insufficient to infiltrate all around the wound, it is advisable to dilute the immunoglobulin in sterile normal saline to a volume sufficient to infiltrate all wounds.
   In situations, where immunoglobulin was not administered with the first dose of the vaccine it can be given upto the 7th day. Beyond the 7th day in a vaccinated person, rabies immunoglobulin in not indicated since an antibody response to anti rabies vaccine is presumed to have occurred.
8. PRESENTATION:
   5 ml vial containing not less than 1500 I.U. of the serum.
9. CONTRAINDICATIONS:
   • Since ERIG is a heterologous serum both Type I (anaphylaxis, including urticaria) and Type III (immune-complex) reactions can occur.
   • Reaction can occur during or after the treatment even if the hyper sensitivity test is negative.
   • Anaphylactic reactions can occur even with the test dose.
10. ADVERSE REACTIONS (IF ANY):
    Immediate or delayed hypersensitivity type reactions may develop with administration of Anti Rabies Serum.