สารบัญ

Thai name เซรุ่มแก้พิษงูกะปะ (SERUM KAE PHIT NGU KAPA)

Category Passive immunizing agent.

          Malayan Pit Viper Antivenin is a sterile preparation containing the specific antitoxic globulins from immunized animals. It has the power of neutralizing the Malayan pit viper (Calloselasma rhodostoma) 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; Warning See under Cobra Antivenin, p. 232.

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 Malayan pit viper 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 Malayan pit viper 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 Malayan pit viper venom stated on the label when determined by the “Biological Assay of Cobra Antivenin” (Appendix 15.2.7); use the Malayan pit viper test venom for determining its capacity to neutralize the lethal effect.

Usual dose Initial dose 30 ml of liquid or freeze-dried Malayan Pit Viper 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 6 hours according to the clinical symptoms.