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COBRA ANTIVENIN

Naja Antivenin

Thai name เซรุ่มแก้พิษงูเห่า (SERUM KAE PHIT NGU HAO)

Category Passive immunizing agent.

          Cobra Antivenin is a sterile preparation containing the specific antitoxic globulins from immunized animals. It has the power of neutralizing the cobra (Naja kaouthia) venom.

          The antivenin, reconstituted if necessary as stated on the label, complies with the requirements stated under Antisera, with the following modifications.

Description Colourless or slightly yellowish brown transparent liquid. Freeze-dried antivenin consists of solid exhibiting the characteristic structure of a freezedried solid, light cream in colour.

Expiration date When stored under the prescribed conditions, the expiration date is not later than 3 years for liquid antivenin.

          For freeze-dried antivenin, the expiration date have been allowed of up to 5 years.

Warning Reactions to Cobra Antivenin are unfortunately common and often severe. In sensitized persons the administration of a heterologous serum may trigger an anaphylactic reaction. Therefore, it is recommended to take a precise anamnesis and to perform an intradermal test in every case (eventually to begin with a highserum dilution). Before the application of a heterologous serum all the preparations for the treatment of cardiovascular and respiratory complications which may accompany such anaphylactic reactions have to be made. A few days after the injection of a heterologous serum, serum sickness may also occur.

Labelling Complies with the “General Information for Antisera”, p. 225. In addition the label on the container states (1) the number in mg of reference cobra venom neutralized by a specified quantity of the antivenin; (2) the recommended human dose; (3) the nature of the preparation, e.g. natural serum or purified immunoglobulin or treated immunoglobulin and, if purified or treated, the nature of the process.

Identification Specifically neutralizes the cobra venom, rendering it harmless to susceptible animals. The assay may serve as an identification test.

Assay Each ml contains sufficient antitoxic globulins to neutralize the amount of the cobra venom stated on the label when determined by the “Biological Assay of Cobra Antivenin” (Appendix 15.2.7).

Usual dose Initial dose of 100 ml of liquid or freezedried Cobra Antivenin (after reconstitution by accompanying diluent) should be given by slow intravenous infusion (approximately 2 ml per minute). During the observation period, subsequent doses can be given every 12 hours according to the clinical symptoms.

MONOGRAPHS • COBRA ANTIVENIN
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หมายเหตุ / Note : TP II 2011 PAGE 232