TOLFEDINE 60MG TOLFENAMIC ACID 60MG/TABLET
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Summary of Product characteristics
(SPC)
19-06-2017
Active ingredient:
TOLFENAMIC ACID
Available from:
Vetoquinol Australia Pty Ltd
INN (International Name):
tolfenamic acid(60mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
TOLFENAMIC ACID ANTI-INFLAMMATORY-NON-STEROID Active 60.0 mg/Tb
Units in package:
16 Tablets
Class:
VM - Veterinary Medicine
Therapeutic group:
DOG | BITCH | CASTRATE | 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: NOT APPLICABLE; Host/pest details: DOG: [ANTI-INFLAMMATORY AGENT]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [ANTI-INFLAMMATORY AGENT]; A non-steroidal anti inflammatory for use in 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: 1800 032 355
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
TOLFEDINE 60 MG
TOLFENAMIC ACID 60mg/TABLET
A non-steroidal anti-inflammatory for use
in dogs
16 TABLETS
Manufactured by:
Vetoquinol SA
70204 LURE FRANCE
Store below 25
0
C (air
conditioning)
APVMA No. 40462/0998
Batch:
Expiry Date:
Dispose of empty container
by wrapping with paper and
putting in garbage.
APPROVED NON-RLP
AMENDMENT MADE
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Summary of Product characteristics
PRODUCT NAME: TOLFEDINE 6MG AND 60MG TOLFENAMIC ACID/TABLET
PAGE: 1 OF 5
THIS REVISION ISSUED: AUGUST, 2013
SAFETY DATA SHEET
ISSUED BY: AUSRICHTER PTY LTD
PHONE: 02 9517 1166
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
AUSRICHTER PTY LTD
PHONE: 02 9517 1166
2/21 CHESTER ST
FAX: 02 9516 5810
CAMPERDOWN NSW 2050
AUSRICHTER@BIGPOND.COM
CHEMICAL NATURE:
Tolfenamic acid is 2-[(3-chloro-2-methylphenyl)amino]benzoic acid) -
one of the class
of non steroidal anti-inflammatory drugs (NSAIDs).
TRADE NAME:
TOLFEDINE 6MG AND 60MG TOLFENAMIC ACID/TABLET
OTHER NAMES:
This SDS is intended for two different tablet, differing in the
quantity of active
ingredient in the tablets.
PRODUCT USE:
Non-steroidal anti-inflammatory for use in dogs as described on the
product label.
CREATION DATE:
OCTOBER, 2008
THIS VERSION ISSUED:
AUGUST, 2013
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S22, S45, S24/25. Do not breathe dust. In case of accident or if you
feel unwell, contact a doctor
or Poisons Information Centre immediately (show this SDS where
possible). Avoid contact with skin and eyes.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
RESPONSE
P337: If eye irritation persists: seek medical attention.
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: In case of fire; Not Combustible. Use extinguishing media
suited to burning materials.
STORAGE
P402+P404: Store in a dry place. Store in a closed container.
P411+P235
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