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Polyvalent Antisnake Venom Serum I.P.

1. DESCRIPTION:

Liquid antiserum: A clear to slightly opalescent, colorless or pale yellow liquid, free from suspended particles.

Freeze dried antiserum: A cream colored powder or pellets which when reconstituted yields a clear, colorless or pale yellow liquid.

2. COMPOSITION:

Each ml of Antisnake venom antiserum neutralizes not less than the following quantities of standard venoms

Cobra 0.60 mg, Common Krait 0.45 mg, Russell’s Viper 0.60 mg, Saw-Scaled Viper 0.45 mg.

Preservative : Phenol Not more than 0.25 % w/v

3. STORAGE:

Store the freeze dried antiserum in cool, dark place and avoid exposure to excessive heat. Store liquid antiserum at +2-8 0C and should not be allowed to freeze.

4. EXPIRY:

24 months for liquid and 60 months for lyophilized antiserum.

5. TREATMENT / INDICATIONS

For the treatment of poisonous snake bite by cobra, krait and viper snakes found in the Indian subcontinent

6. RECONSTITUTION OF LYOPHILIZED SERUM (IF APPLICABLE)

Reconstitute the content of the vial with 10 ml of the diluents supplied by gentle shaking.

7. PRECAUTIONS

Shake well, withdraw the contents aseptically from the vial.

Do not freeze the contents of the vial.

Protect the contents of the vial from light.

8. POSOLOGY AND ADMINISTRATION

Initial dose should depend upon an estimate of the amount of evenomation as mentioned below:

Evenomation Dose
Minimal ( progressive local swelling, but no systemic symptoms) 5 vials(50ml) are usually sufficient
Moderate (swelling beyond the site of the bite, mild systemic symptoms ,and /or Hematologic & neurological abnormalities) 5 to 10 vials( 50-100 ml)
Severe (rapidly progressive &extensive local effects, systemic symptoms and evidence of hemolysis or neurological abnormalities) 10-20 vials (100-200ml) or more should be administered

In children and small adults (body weight less than 40kg) upto 50% greater doses of anti snake venom serum should be administered to neutralize the relatively higher venom concentration.

Anti snake venom serum is administered intravenously either undiluted at the rate of 1ml. per minute or is diluted in 500ml of intravenous fluid and administered as rapidly as tolerated over 1-2 hrs.

Additional infusions containing 5-10 vials (50-100ml) should be repeated hourly until progressive swelling in the bitten part ceases and systemic signs and symptoms disappear.

When an adequate dose is achieved the improvement in patients clinical signs is often dramatic

It is not advisable to infiltrate antisnake venom serum at the local site.

Test for Sensitivity: For sensitivity testing of anti snake venom serum ,0.1ml. of serum diluted in “ Sterile water for injection-IP” is injected intradermally .The patient should be observed for 30mins for local and general reaction. In case of no reactions the treatment should be started. If the patient shows local reaction or anaphylactic symptoms, anti snake venom serum should be given after desensitizing and/ or under cover of anti- anaphylactic drugs.

9. PRESENTATION:

10 ml vial in liquid/ lyophilized form

10. CONTRAINDICATIONS/ WARNINGS

  • Anaphylactic reactions can occur during or after the treatment even if the hypersensitivity test is negative.
  • Anaphylactic reactions can occur even with the test dose.
  • Necessary facilities for the management of such cases should always be kept ready.

ADVERSE REACTIONS (IF ANY) :

Anti snake venom serum being of Equine origin can give all the adverse reactions associated with the administration of heterologous serum. Immediate reaction is mild to severe anaphylactic reaction and delayed reactions are those related to immune complex diseases and serum sickness