TOLFEDINE INJECTABLE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TOLFENAMIC ACID

Available from:

VETOQUINOL AUSTRALIA PTY LTD

INN (International Name):

tolfenamic acid(40mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

TOLFENAMIC ACID ANTI-INFLAMMATORY-NON-STEROID Active 40.0 mg/ml

Units in package:

10mL

Class:

VM - Veterinary Medicine

Therapeutic group:

CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Therapeutic indications:

ANTI-INFLAMMATORY AGENT | ANTIPYRETIC | BONE SORENESS | BRUISING | BURSITIS | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MUSCLE SORENESS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SPRAINS | STRAINS | TENDON SPRAINS | TRAUMATIC SWELLING

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ANTI-INFLAMMATORY AGENT]; DOG: [ANTI-INFLAMMATORY AGENT]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANTI-INFLAMMATORY AGENT]; DOG: [ANTI-INFLAMMATORY AGENT]; A non-steroidal anti-inflammatory for use in dogs and cats.NOT TO BE USED in food producing species. Do not use in animals receiving corticosteroids or other NSAIDs, suffering cardiac, hepatic or renal disease, which show signs of g. intestinal ulceration or bleeding, where there is evidence of blood dyscrasia.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_TOLFEDINE_
_INJECTABLE_
TOLFENAMIC ACID 40 MG/ML
Non Steroidal
Anti-Inflammatory agent
for use in dogs and cats
10ML
Manufactured by:
VETOQUINOL S.A.,
MAGNY VERNOIS,
70200 Lure (France)
Distributed by:
VETOQUINOL AUSTRALIA PTY LTD
Unit 302/2, 6-12 Boronia Road,
DaVinci Business Park,
Brisbane Airport, Qld, 4008
Phone: [phone]
[e-mail]
Dispose
of
empty
container
by
wrapping with paper and putting in
garbage.
434884 0615 F
For
batch
and
expiry
see
bottom flap.
APVMA Approval No.: 40464/0699
STORE BELOW 25˚C
(Air Conditioning) away from
direct sunlight.
_TOLFEDINE_
_®_
_INJECTABLE_
DIRECTIONS FOR USE
NOT
TO
BE
USED
IN
FOOD
PRODUCING SPECIES OF ANIMALS.
Contraindicated
in
animals
receiving corticosteroids or other
NSAIDs. Contraindicated in animals
suffering
from
cardiac,
hepatic
or renal disease. Contraindicated
in
animals
showing
signs
of
gastrointestinal ulceration or bleed-
ing and where there is evidence of
blood dyscrasia.
Use in animals under 6 weeks of
age
or
aged
animals
is
not
recommended.
DOSAGE AND
ADMINISTRATION
4 mg/kg (1mL/10kg) to be given
once
daily
by
subcutaneous
or
intramuscular
injection
for
a
maximum of 5 days.
_®_
10ML
ETUI tolfedine Australie 434884 0513 F_ETUI tolfedine Australie 434884
0513 A 08/07/15 08:39 Page1
APPROVED NON-RLP
AMENDMENT MADE
Lot:
Exp.:
DIRECTIONS FOR USE: NOT TO BE USED IN
FOOD PRODUCING SPECIES
OF
ANIMALS.
Contraindicated
in
animals:
Receiving
corticosteroids or other NSAIDs. Suffering
from cardiac,
hepatic or
renal
disease.
Showing signs of
gastrointestinal
ulcera-
tion or bleeding and where there is evi-
dence of blood dyscrasia. Use in animals
under 6 weeks of age is not recommended.
STORE
BELOW 25˚C (air
conditioning)
away from direct sunlight.
APVMA Approval No.: 40464/0699
_Distributed by: _VETOQUINOL AUSTRALIA PTY LTD, Unit302/
2, 6-12 Boronia Road, DaVinci Business Park, Brisbane Airport,
Qld, 4008. Phone: [phone] [e-mail]

Summary of Product characteristics

PRODUCT NAME: TOLFEDINE 4%
PAGE: 1 OF 5
THIS VERSION ISSUED: JANUARY, 2016
SAFETY DATA SHEET
Issued by: Vetoquinol Australia Pty Ltd
Phone: [phone]
(BUSINESS HOURS)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
VETOQUINOL AUSTRALIA PTY LTD
PHONE: [phone] (BUSINESS HOURS)
UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK,
FAX: [phone]
BRISBANE AIRPORT, QLD 4008
CHEMICAL NATURE:
Tolfedine is a highly effective and safe Non Steroidal
Anti-Inflammatory, COX-2
preferential inhibitor.
TRADE NAME:
TOLFEDINE 4%
PRODUCT USE:
Nonsteroidal anti-inflammatory, analgesic, antipyretic for veterinary
uses.
CREATION DATE:
JANUARY, 2016
THIS VERSION ISSUED:
JANUARY, 2016
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xi, Irritating. N, Dangerous to the environment. Hazardous according
to the criteria of
SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P402+P404: Store in a dry place. Store in a closed container.
P403+P235: Store in a well-ventilated place. Keep cool, below 30°C.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larg

Safety Data Sheet

PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_TOLFEDINE_
_INJECTABLE_
TOLFENAMIC ACID 40 MG/ML
Non Steroidal
Anti-Inflammatory agent
for use in dogs and cats
10ML
Manufactured by:
VETOQUINOL S.A.,
MAGNY VERNOIS,
70200 Lure (France)
Distributed by:
VETOQUINOL AUSTRALIA PTY LTD
Unit 302/2, 6-12 Boronia Road,
DaVinci Business Park,
Brisbane Airport, Qld, 4008
Phone: [phone]
[e-mail]
Dispose
of
empty
container
by
wrapping with paper and putting in
garbage.
434884 0615 F
For
batch
and
expiry
see
bottom flap.
APVMA Approval No.: 40464/0699
STORE BELOW 25˚C
(Air Conditioning) away from
direct sunlight.
_TOLFEDINE_
_®_
_INJECTABLE_
DIRECTIONS FOR USE
NOT
TO
BE
USED
IN
FOOD
PRODUCING SPECIES OF ANIMALS.
Contraindicated
in
animals
receiving corticosteroids or other
NSAIDs. Contraindicated in animals
suffering
from
cardiac,
hepatic
or renal disease. Contraindicated
in
animals
showing
signs
of
gastrointestinal ulceration or bleed-
ing and where there is evidence of
blood dyscrasia.
Use in animals under 6 weeks of
age
or
aged
animals
is
not
recommended.
DOSAGE AND
ADMINISTRATION
4 mg/kg (1mL/10kg) to be given
once
daily
by
subcutaneous
or
intramuscular
injection
for
a
maximum of 5 days.
_®_
_VÉTOQUINOL_
_DIMENSIONS: 33x33x65 mm_
_RÉFÉRENCE ARTICLE: 434884 0615 F_
_NOM DU PRODUIT: Tolfedine 4% Australie _
_QUADRI_
_REV F_
_485_
_329_
_NOIR_
_CRÉÉ PAR: P. Mougenot_
_LE 8/07/2015_
_VISA:_
_7740_
_375_
10ML
ETUI tolfedine Australie 434884 0513 F_ETUI tolfedine Australie 434884
0513 A 08/07/15 08:39 Page1
Lot: Exp.:
_VÉTOQUINOL - Australie_
_DIMENSIONS : 60x22 mm_
_RÉFÉRENCE ARTICLE : 434885 0615 D_
_NOM DU PRODUIT : Tolfedine 4% _
_QUADRI_
_NOIR_
_CRÉÉ PAR : P. Mougenot_
_LE : 29/06/2015_
_VISA :_
_REV D_
_CORRESPONDANCES_
_PANTONE_
DIRECTIONS FOR USE: NOT TO BE USED IN
FOOD
PRODUCING
SPECIES
OF
ANIMALS.
Contraindicated
in
animals:
Receiving
corticosteroids or other NSAIDs. Suffering
from cardiac, hepatic or renal disease.
Showing signs of gastrointesti