NADA Number: 140-583 | |
| Proprietary Name |
ACTH Gel |
|---|---|
| Sponsor |
Cross Vetpharm Group Ltd. |
| Sponsor Address |
Broomhill rd. Tallaght, Dublin, 24 IRELAND |
| Ingredients |
Corticotropin |
| Species |
Cat, no use class stated or implied Dog, no use class stated or implied |
| Routes of Administration |
Intramuscular Subcutaneous |
| Dose Form |
Liquid |
| Drug Form |
Liquid |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
522.480 Repository corticotropin injection. Specifications: The drug conforms to repository corticotropin injection U.S.P. It contains 40 or 80 U.S.P. units per milliliter. Conditions of use: Dogs Amount: For diagnostic use: Administer at one unit per pound of body weight intramuscularly. Indications: For intramuscular injection as a diagnostic aid to test for adrenal dysfunction. Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Amount: Administer at one unit per pound of body weight intramuscularly or subcutaneously, to be repeated as indicated. Indications: For intramuscular or subcutaneous injection for stimulation of the adrenal cortex where there is a general deficiency of ACTH. Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Cats Amount: Administer at one unit per pound of body weight intramuscularly or subcutaneously, to be repeated as indicated. Indications: For intramuscular or subcutaneous injection for stimulation of the adrenal cortex where there is a general deficiency of ACTH. Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian. NAS/NRC status: National Academy of Sciences/National Research Council (NAS/NRC) status. The therapeutic indication for use has been reviewed by NAS/NRC and found to be effective. Applications for this use need not include effectiveness data as specified in 514.111 of this chapter, but may require bioequivalency and safety information.] |