Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
Capromorelin (UNII: 0MQ44VUN84) (Capromorelin - UNII:0MQ44VUN84)
Elanco US Inc.
ORAL
PRESCRIPTION
ELURA should not be used in cats that have a hypersensitivity to capromorelin.
20 mg/mL flavored oral solution in a 15 mL bottle with an oral dosing syringe. Approved by FDA under NADA # 141-536. Manufactured for: Elanco US Inc, Greenfield, IN 46140 USA REV. DATE-10/2020 ELURA, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. PA402828X ©2020 Elanco
New Animal Drug Application
ELURA- CAPROMORELIN SOLUTION ELANCO US INC. ---------- ELURA™ (capromorelin oral solution) 20 mg/mL For oral use in cats only CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: ELURA (capromorelin oral solution) is a colorless to yellow or orange, clear liquid. Each milliliter of ELURA contains 20 mg of capromorelin tartrate. The empirical formula is C H N O ·C H O and the molecular weight 655.70. The chemical name is 2-aminoN- [2-(3aR-benzyl-2-methyl-3-oxo-2,3,3a,4,6,7-hexahydro-pyrazolo[4,3-c]pyridine-5-yl)-1R- benzyloxymethyl-2-oxo-ethyl]-isobutyramide L-tartrate. The chemical structure of capromorelin tartrate is: INDICATION: For management of weight loss in cats with chronic kidney disease. DOSAGE AND ADMINISTRATION: Administer ELURA orally at a dose of 2 mg/kg (0.9 mg/lb) or 0.1 mL/kg (0.045 mL/lb) body weight once daily. To administer ELURA: Remove the cap, insert the dosing syringe, invert the bottle, withdraw the appropriate amount of solution. Return the bottle to the upright position, remove syringe, replace the cap. Administer the solution into the cat's mouth. Rinse the syringe and plunger with water and leave apart to dry. If the cat is routinely fed meals, offer food 30 minutes after administering the dose. If the cat vomits within 15 minutes or only receives a partial dose, then the dose may be re-administered. 28 35 5 4 4 6 6 CONTRAINDICATIONS: ELURA should not be used in cats that have a hypersensitivity to capromorelin. WARNINGS: Not for use in humans. Keep this and all medications out of reach of children and pets. Consult a physician in case of accidental ingestion by humans. FOR ORAL USE IN CATS ONLY. Do not use in cats with hypersomatotropism (acromegaly). ELURA may increase serum glucose for several hours after dosing (see Animal Safety and Clinical Pharmacology). Use in cats with current or historical diabetes mellitus has not been evaluated and use may not be appropriate. PRECAUTIONS: Use with caution in cats that may have Baca dokumen lengkapnya