21 C.F.R. § 522.1020   Gelatin solution.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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§ 522.1020   Gelatin solution.

(a) Specifications. It is sterile and each 100 cubic centimeters contains 8 grams of gelatin in an 0.85 percent sodium chloride solution.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is used to restore circulatory volume and maintain blood pressure in animals being treated for shock.

(2) The exact dosage to be administered must be determined after evaluating the animal's condition and will vary according to the size of the animal and the degree of shock. A suggested dosage range for small animals such as dogs is 4 to 8 cubic centimeters per pound body weight. The suggested dosage range for large animals such as sheep, calves, cows, or horses is 2 to 4 cubic centimeters per pound of body weight. It is administered intravenously at a rate of 10 cubic centimeters per minute in small animals and 20 to 30 cubic centimeters per minute in large animals. The solution is administered aseptically and must be between 50 to 70 °F. when injected.

(3) A few animals will exhibit signs of allergic reaction. This solution can cause transient reversible nephrosis. This product is not intended to replace whole blood in cases of anemia and should not be used in the presence of renal dysfunction. Unused portions remaining in bottles should be discarded.

(4) For use only by or on the order of a licensed veterinarian.

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