Complete Up To Date Information about Dexium-SP™.
ANADA Number: 200-317 | |
| Proprietary Name |
Dexium-SP™ |
|---|---|
| Sponsor |
Cross Vetpharm Group Ltd. |
| Sponsor Address |
Broomhill rd. Tallaght, Dublin, 24 IRELAND |
| Ingredients |
Dexamethasone Sodium Phosphate |
| Species |
Horse, not for meat production |
| Routes of Administration |
Intravenous |
| Dose Form |
Liquid (solution) |
| Drug Form |
Liquid (solution) |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
522.540 Dexamethasone injection. Specifications: The drug is a sterile aqueous solution. Each milliliter contains 4.0 milligrams of dexamethasone sodium phosphate (equivalent to 3.0 milligrams dexamethasone). Conditions of use: Horses Amount: The drug is administered intravenously at a dosage of 2.5 to 5.0 milligrams. If permanent corticosteroid effect is required, oral therapy may be substituted. When therapy is withdrawn after prolonged use, the daily dose should be reduced gradually over several days. Indications: The drug is used as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses. Limitations: Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. NAS/NRC status: These conditions are NAS/NRC-reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by 514.111 of this chapter, but may require bioequivalency and safety information. |