TOLFEDINE 6MG TOLFENAMIC ACID 6MG/TABLET

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(6mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

TOLFENAMIC ACID ANTI-INFLAMMATORY-NON-STEROID Active 6.0 mg/Tb

Units in package:

20 Tablets

Class:

VM - Veterinary Medicine

Therapeutic group:

CAT | DOG - SMALL OR TOY | CAT - QUEEN | CAT - TOM | DOG - SMALL | DOG - TOY | KITTEN

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: NOT APPLICABLE; Host/pest details: CAT: [ANTI-INFLAMMATORY AGENT]; DOG - SMALL OR TOY: [ANTI-INFLAMMATORY AGENT]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANTI-INFLAMMATORY AGENT]; DOG - SMALL OR TOY: [ANTI-INFLAMMATORY AGENT]; A non-steroidal anti-inflammatory for use in cats and miniature dogs.Do not use in animals receiving corticosteroids or other NSAIDs, suffering from cardiac, hepatic or renal disease, which show signs of G.I. Ulceration or bleeding, where there is evidence of blood dyscrasia. Use in animals under 6 weeks of age NOT recomm.

Authorization status:

Stopped

Authorization date:

2019-06-30

Patient Information leaflet

DIRECTIONS FOR USE
DOSE ANO ADMINISTRATION
Not for use in food producing
animals.
Do not use in animals receiving
corticosteroids or other NSAIDS.
Do not use in animals suffering
from cardiac, hepatic or renal
disease, which show signs of
gastrointestinal ulceration or
bleeding, where there is
evidence of blood dyscrasia.
Use in animals under 6 weeks of
age is not recommended.
4 mg Tolfenamic acid/kg of
bodyweight once daily for 3 to 5
days. Each 601119 tablet treats
15kg of bodyweight. Tolfedine
tablets may be used as an
alternative to Tolfedine
injectable:
A suggested administration
regime is an initial treatment with
Tolfedine injectable followed by
Tolfedine tablets on subsequent
days.
Distributed By:
Vetoquinol Australia
Ply. Ltd.,
Unit 302/2, 6-12 Boronia
Road DaVinci Business
Park
Brisbane Airport,
Qld, 4008
Tel: [phone]
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
TOLFEDINE 6 MG
TOLFENAMIC ACID 6mg/TABLET
A non-steroidal anti-inflammatory for use
in dogs
20 TABLETS
Manufactured by:
Vetoquinol SA
70204 LURE FRANCE
Store below 25
0
C (air
conditioning)
APVMA No. 40463/0998
Batch:
Expiry Date:
Dispose of empty container
by wrapping with paper and
putting in garbage.
APPROVED NON-RLP
AMENDMENT MADE

Summary of Product characteristics

PRODUCT NAME: TOLFEDINE 6 MG
PAGE: 1 OF 5
THIS VERSION ISSUED: OCTOBER, 2015
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, which is indicated for both cats and dogs for
a variety of short
and long-acting applications.
TRADE NAME:
TOLFEDINE 6 MG
OTHER NAMES:
Tolfenamic acid 6mg/tablet
APVMA CODE:
40463
PRODUCT USE:
Non steroidal anti-inflammatory for use in cats and miniature dogs.
FOR VETERINARY USE ONLY.
CREATION DATE:
OCTOBER, 2015
THIS VERSION ISSUED:
OCTOBER, 2015
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:
Xn, Harmful. Hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
R22. Harmful if swallowed.
SAFETY PHRASES:
S20, S22, S25, S36. When using, do not eat or drink. Do not breathe
dust. Avoid contact with
eyes. Wear suitable protective clothing.
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: WARNING
HAZARD STATEMENT:
H302: Harmful if swallowed.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contacted areas thoroughly after handling.
P281: Use personal protective equipment as required.
RESPONSE
P352: Wash with plenty of soap and water.
P301+P312: IF SW