ONSIOR (ROBENACOXIB) injection solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

robenacoxib (UNII: Z588009C7C) (robenacoxib - UNII:Z588009C7C)

Доступно од:

Novartis Animal Health US, Inc.

INN (Међународно име):

robenacoxib

Састав:

robenacoxib 20 mg in 1 mL

Тип рецептора:

PRESCRIPTION

Статус ауторизације:

New Animal Drug Application

Карактеристике производа

ONSIOR (ROBENACOXIB)- ROBENACOXIB INJECTION, SOLUTION
NOVARTIS ANIMAL HEALTH US, INC.
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ONS IOR
(ROBENACOXIB)
INJECTION
FOR SUBCUTANEOUS USE IN CATS ONLY
20 MG/ML INJECTION FOR CATS
CAUTION:
FEDERAL (USA) LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A
LICENSED VETERINARIAN.
DES CRIPTION:
ONSIOR (robenacoxib) injection is a non-narcotic, non-steroidal
anti-inflammatory drug (NSAID) of the
coxib class. Each mL of this clear sterile solution for injection
contains 20 mg robenacoxib, 350 mg
polyethylene glycol 400, 120 mg ethanol, 100 mg poloxamer 188, 1 mg
sodium metabisulfite; citric
acid and sodium hydroxide are used for pH adjustment. The molecular
weight of robenacoxib is 327.28.
The empirical formula is C
-H -F -NO .
Robenacoxib is
[5-Ethyl-2-(2,3,5,6-tetrafluoro-phenylamino)-phenyl]-acetic acid. The
structural
formula is:
INDICATION:
ONSIOR (robenacoxib) injection is indicated for the control of
postoperative pain and inflammation
associated with orthopedic surgery, ovariohysterectomy and castration
in cats ≥ 4 months of age; for up
to a maximum of 3 days.
DOSAGE AND ADMINISTRATION:
CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF ONSIOR AND
OTHER TREATMENT OPTIONS BEFORE
DECIDING TO USE ONSIOR (ROBENACOXIB) INJECTION. Use the lowest
effective dose for the shortest
duration consistent with individual response. It is recommended as
good aseptic practice to clean
stopper surface with isopropyl alcohol before and after each insertion
of a needle.
The dose of ONSIOR (robenacoxib) injection is 0.91 mg/lb (2 mg/kg)
subcutaneously once daily, for a
maximum of 3 days.
Dosage Directions: For subcutaneous injection in cats ≥ 4 months of
age; for up to a maximum of 3
days. To ensure accuracy of dosing, the use of a 1 mL graduated
syringe is recommended. The first
dose should be administered approximately 30 minutes prior to surgery,
at the same time as the
preanesthetic agents are given.
Subsequent doses can be given via subcutaneous injection, or
interchanged with the oral tablet in cats ≥
5