Onsior 20 mgml Solution for Injection for Cats and Dogs

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

Robenacoxib

Inapatikana kutoka:

ELANCO MALAYSIA SDN BHD

INN (Jina la Kimataifa):

Robenacoxib

Vitengo katika mfuko:

20 ml

Viwandani na:

Bela-Pharm GmbH & Co. KG

Taarifa za kipeperushi

Not Applicable

Tabia za bidhaa

140 mm
240 mm
LEGEND KEY
Template: PI_140x240mm_v1
Text Free Area
50 mm Rule Bar
NON PRINTING
BLACK
PI_140x240mm_v1
SINR: 312264
7.9 point
SG 31-MAY-2022
P1a
ELANCO ARTWORK LEGEND v16
213352AP
PA213352X
CA4886
N/A
Onsior injection for cats and dogs 20mg/ml
Package Inserts and Leaflets
20ml
Bela-Pharm Code: 04/22 G1710054NOMY
N/A
GTIN Not Required
PA213352X
312264
04/22   G1710054NOMY
Onsior 20 mg/ml solution for injection
for cats and dogs
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND
OTHER INGREDIENT(S)
Each ml contains 20 mg robenacoxib as active
substance and 1 mg sodium metabisulphite as
an antioxidant.
The solution for injection is a clear, colourless to slightly
coloured (pink) liquid.
TARGET SPECIES
Cats and dogs.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anti-inflammatory and
antirheumatic products, non-steroids, coxibs. ATCvet
code: QM01AH91.
PHARMACODYNAMIC PROPERTIES
Robenacoxib is a non-steroidal anti-inflammatory drug
(NSAID) of the coxib class. It is a potent and selective
inhibitor of the cyclooxygenase 2 enzyme (COX-2). The
cyclooxygenase enzyme (COX) is present in two forms.
COX-1 is the constitutive form of the enzyme and has
protective functions, e.g. in the gastrointestinal tract
and kidneys. COX-2 is the inducible form of the enzyme
and is responsible for the production of mediators
including PGE2 which induce pain, inflammation or fever.
In cats, using an in vitro whole blood assay, robenacoxib
was approximately 500 fold selective for COX-2 (IC50
0.058 μM) as compared to COX-1 (IC50 28.9 μM). In vivo,
robenacoxib solution for injection produced marked
inhibition of COX-2 activity and had no effect on
COX-1 activity. At the recommended dosage (2 mg/kg),
analgesic, anti-inflammatory and anti-pyretic effects were
demonstrated in an inflammation model, and in clinical
trials, robenacoxib reduced pain and inflammation in cats
undergoing orthopaedic or soft tissue surgery.
In dogs, robenacoxib was in vitro approximately 140 fold
selective for COX-2 (IC50 0.04 μM) as compared to
COX-1