ONSIOR 5MG TABLETS FOR DOGS

Pays: Australie

Langue: anglais

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Achète-le

Ingrédients actifs:

ROBENACOXIB

Disponible depuis:

ELANCO AUSTRALASIA PTY LTD

DCI (Dénomination commune internationale):

robenacoxib(5mg/mL)

forme pharmaceutique:

ORAL TABLET

Composition:

ROBENACOXIB ANTI-INFLAMMATORY-NON-STEROIDA Active 5.0 mg/Tb

Unités en paquet:

30 tablets; 6 tablets

classe:

VM - Veterinary Medicine

Fabriqué par:

ELANCO AUSTRALASIA

Groupe thérapeutique:

DOG | BITCH | CASTRATE | PUPPY

Domaine thérapeutique:

MUSCULOSKELETAL SYSTEM

indications thérapeutiques:

ORTHOPAEDIC - INFLAMATION | PAIN/INFLAMMATION ASSOCIATED WITH NONINF

Descriptif du produit:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [ORTHOPAEDIC - INFLAMATION, PAIN/INFLAMMATION ASSOCIATED WITH NONINF]; For the control of pain and inflammation associated with chronic osteoarthritis or orthopaedic or soft tissue surgery in dogs.See Contraindications, Precautions sections etc on label.

Statut de autorisation:

Registered

Date de l'autorisation:

2023-07-01

Notice patient

                                PRODUCT NAME: ONSIOR 5 mg Tablets for Dogs
APVMA No. 63104
ACVM: A10704
Date:
30 October2013
Text above this line is not included
Blister !international!
ONSIOR
5
mg
robenacoxib
Tablets for dogs
For animal treatment only
NOVARTIS LOGO
EXP
LOT
+
RLP
Approvt·•'
Product
name: ONSIOR 5
mg
Tablets for Dogs
APVMA
No.
63104
ACVM: A 10704
Date:
30 October 2013
Text above this line is not included
Carton-
front panel
PRESCRIPTION
ANIMAL
REMEDY
KEEP OUT OF REACH OF CHILDREN
READ
SAFETY
DIRECTIONS BEFORE OPENING
OR
USING
FOR
ANIMAL
TREATMENT
ONLY
ONSIOR® 5
mg
Tablets
for
Dogs
Each tablet contains 5 mg robenacoxib
For the control
of
pain and inflammation associated with chronic osteoarthritis or
orthopaedic or soft tissue surgery in dogs.
7 tablets [ 28 tablets]
NOVARTIS LOGO
Product
name:
ONSIOR
_5 _
mg
Tablets for Dogs
APVMA No. 63104
ACVM: Al0704
Date:
30 October2013
Text
above this line is
not
included
Carton -
back panel
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
ONSIOR Tablets should be given on an empty stomach
or
with only a small
amount
of
food. The recommended dose rate and regime should not be
exceeded.
For control
of
pain and inflammation associated with chronic osteoarthritis
Administer orally once per day at a dose
of
1 mg/kg bodyweight with a range
of
1-2 mg/kg.
For control
of
pain and inflammation associated with orthopaedic or soft tissue
surgery
Initiate treatment with a SINGLE dose
of
ONSIOR Injection administered
subcutaneously before commencement
of
surgery, for example around the time
of
induction
of
general anaesthesia or initiation
of
supportive fluid therapy, at a
dose
of
2 mg/kg ( 1
ml
per 10
kg
bodyweight). If treatment is to
be
continued,
ONSIOR Tablets may
be
administered orally at 1 mg/kg bodyweight, dose range
1-2 mg/kg, ONCE daily for up to 12 days.
The enclosed leaflet describes directions for use and precautions to
follow when
administering ONSIOR Tablets.
Safety
Directions
May
irritate
the
eyes.
Avoid
contact
with
eyes. Wash
hands
after use.
First
Aid
If
pois
                                
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Résumé des caractéristiques du produit

                                Version: 1
Date issued December 2010
ONSIOR
® 5 MG TABLETS FOR DOGS
Page 1 of 4
MATERIAL SAFETY DATA SHEET
SECTION 1. IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT INFORMATION
Substance No.
:
000070002357
NAH Substance Code
:
A-20022 D
Product name
:
ONSIOR 5 mg Tablets for Dogs
Product use
:
For the control of pain and inflammation associated with chronic
osteoarthritis or
orthopaedic or soft tissue surgery in dogs
COMPANY
:
Novartis Animal Health Australasia Pty Ltd
ACN 076 745 198
54 Waterloo Road
North Ryde NSW 2113
Telephone
:
(02) 9805 3555
Fax
:
(02) 9888 8387
:
MSDS creation date
MSDS revision date
:
December 2010
December 2015
:
:
SECTION 2. HAZARDS IDENTIFICATION
RISK ADVICE TO MAN AND THE ENVIRONMENT
Health hazards
:
No hazards to be specially mentioned.
Environmental hazard in case
of accident (Spillage/Leakage)
SUSDP classification
:
No hazards to be specially mentioned.
S4
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
CHEMICAL NATURE
Use
:
Veterinary medicinal product / Anti-inflammatory
Type of preparation
:
Tablet vet. use
HAZARDOUS COMPONENTS
Denomination
CAS-No.
Symbol(s)
R-phrase(s)
For the full text of the R-phrases mentioned in
this Section, see Section 16.
Concentration (% w/w)
Robenacoxib
220991-32-2
Xn, N
R63, R51/53
6.25
SECTION 4. FIRST AID MEASURES
Label regulated first aid
statement
General advice
:
If poisoning occurs contact a doctor or Poisons Information Centre
(Phone 13 1126).
If you feel unwell, seek medical advice (show the label where
possible).
Skin contact
:
Wash off with soap and water.
Eye contact
:
Rinse eyes with clean water for several minutes .
Ingestion
:
Drink water as a precaution.
NOTES TO PHYSICIAN
Poisoning Symptoms
:
No information available.
Antidote
:
No specific antidote is known! Apply symptomatic therapy.
Version: 1
Date issued December 2010
ONSIOR
® 5 MG TABLETS FOR DOGS
Page 2 of 4
MATERIAL SAFETY DATA SHEET
SECTION 5. FIRE-FIGHTING MEASURES
Combustibility
:
yes
Suitable extinguishing media
:
Dry powder, foam, carbon dioxide (CO2) or water s
                                
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