ELURA- capromorelin solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

Capromorelin (UNII: 0MQ44VUN84) (Capromorelin - UNII:0MQ44VUN84)

Предлага се от:

Elanco US Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION

Терапевтични показания:

ELURA should not be used in cats that have a hypersensitivity to capromorelin.

Каталог на резюме:

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

Статус Оторизация:

New Animal Drug Application

Данни за продукта

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