Diphtheria Antitoxin I.P. (Liquid)

1. DESCRIPTION:
   Diphtheria Antitoxin is a preparation containing the specific globulin having specific activity of neutralizing the toxin formed by Corynebacterium diphtheria. It is obtained by purification of hyper-immune serum/plasma of healthy equines.
2. COMPOSITION:
   Each ml of Diphtheria Antitoxin serum contains:
   - Enzyme refined Equine globulin > or =1000 IU
   - Preservative, Phenol < or =0.25%
3. STORAGE:
   2 - 8⁰C in dark and should not be allowed to freeze.
4. EXPIRY:
   24 months.
5. TREATMENT / INDICATIONS:
   Diphtheria antitoxin should be administered as soon as the clinical evidence of the disease appears. Administration of the antitoxin should not await bacteriologic confirmation of the diagnosis since the condition of the patient with diphtheria can deteriorate rapidly.
6. PRECAUTIONS :
   • Shake well, withdraw the required dose aseptically from the vial
   • Do not freeze the contents of the vial
   • Protect the constituents of the vial from bright light
   • A 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 DAT as follows:
     • Inject 0.1ml of DAT diluted in 1 in 10 in “sterile water for injection (WFI) I.P.” intradermally into the flexor surface of the forearm.
     • 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 30 minutes observe for focal and general reactions. An urticaria wheal, with or without pseudopods, surrounded by a zone of erythema indicates a positive skin test, provided the reaction on the water for injection test is negative.
     • In case of negative skin test, the treatment may be started.
     • In case of positive skin test, Diphtheria antitoxin may be administered after desensitization and/or under the cover of anti-anaphylactic drugs
7. POSOLOGY AND ADMINISTRATION:
   DOSE – As per the recommendation of the physician.
   Mild to moderate cases – 10,000 – 30,000 I.U. may be given intramuscularly.
   Severe cases – 40,000 – 100,000 I.U. initial portion of the dose intramuscularly and rest intravenously after a gap of 30 minutes to 2 hours.
8. PRESENTATION: Each vial containing not less than 10,000 I.U. of the serum.
9. CONTRAINDICATIONS:
   • Since DAT 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 skin sensitivity test is negative.
   • Anaphylactic reactions can occur even with the test dose. (Necessary facilities for management of such cases should always be kept ready).
10. 10.ADVERSE REACTIONS (IF ANY):
    Immediate or delayed hypersensitivity type reactions may develop with administration of DAT.