CFR

522.2474—Tolazoline hydrochloride injection.

(a) Specifications. Each milliliter of sterile aqueous solution contains tolazoline hydrochloride equivalent to 100 milligrams of base activity.

(b) Sponsor. See No. 061690 in § 510.600(c) of this chapter.

(1) Horses— (i) Amount. Administer slowly by intravenous injection 4 milligrams per kilogram of body weight or 1.8 milligrams per pound (4 milliliters per 100 kilograms or 4 milliliters per 220 pounds).

(ii) Indications for use. For use in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine.

(iii) Limitations. The safety of Tolazine TM has not been established in pregnant mares, lactating mares, horses intended for breeding, foals, or horses with metabolically unstable conditions. The safety of Tolazine TM has not been evaluated for reversing xylazine used as a preanesthetic to a general anesthetic. This drug is for use in horses only and not for use in food-producing animals. Users with cardiovascular disease (for example, hypertension or ischemic heart disease) should take special precautions to avoid accidental exposure to this product.

Accidental spillage on the skin should be washed off immediately with soap and water. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

Code of Federal Regulations

[61 FR 25785, May 23, 1996]

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