ADVERSE REACTIONS
Anaphylaxis and serum sickness have been reported following use of Antivenin.
DOSAGE AND ADMINISTRATION
Using a sterile syringe, remove from the accompanying vial 2.5 mL of Sterile Diluent for Antivenin and inject into the vial of Antivenin. With the needle still in the rubber stopper, shake the vial to dissolve the contents completely.
Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit (see DESCRIPTION).
The dose for adults and children is the entire contents of a restored vial (2.5 mL) of Antivenin. It may be given intramuscularly, preferably in the region of the anterolateral thigh so that a tourniquet may be applied in the event of a systemic reaction. Symptoms usually subside in 1 to 3 hours. Although one dose of Antivenin usually is adequate, a second dose may be necessary in some cases.
Antivenin also may be given intravenously in 10 to 50 mL of saline solution over a 15 minute period. It is the preferred route in severe cases, or when the patient is under 12, or in shock. One restored vial usually is enough.
HOW SUPPLIED
No. 4084--Antivenin (Latrodectus mactans) equine origin is a white to grey crystalline powder, each vial containing not less than 6000 Antivenin units. Thimerosal (mercury derivative) 1:10,000 is added as preservative, NDC 0006-4084-00. A 2.5 mL vial of Sterile Diluent for Antivenin is included. Also supplied is a 1 mL vial of normal horse serum (1:10 dilution) for sensitivity testing. Thimerosal (mercury derivative) 1:10,000 is added as preservative.
Storage
Antivenin must be stored and shipped at 2-8°C (36-46°F). When reconstituted as directed, the color of Antivenin ranges from light (straw) to very dark (iced tea), but the color has no effect on potency. Do not freeze.
A.H.F.S. Category: 80:04
7972115 Issued October 2003
|
