TOLFEDINE 20MG TOLFENAMIC ACID 20MG/TABLET
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
20-06-2017
Summary of Product characteristics
(SPC)
20-06-2017
Active ingredient:
TOLFENAMIC ACID
Available from:
Vetoquinol Australia Pty Ltd
INN (International Name):
tolfenamic acid(20mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
TOLFENAMIC ACID ANTI-INFLAMMATORY-NON-STEROID Active 20.0 mg/Tb
Units in package:
16 Tablets
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 cats and dogs.DO NOT use in food producing animals. DO NOT use in animals receiving corticosteroids or other NSAIDS. Use in animals under 6 weeks of age is NOT recommended. CONTRAINDICATIONS, etc: See Label.
Authorization status:
Stopped
Authorization date:
2019-06-30
Patient Information leaflet
PROG.B19516J1
VETOQUINOL
44 X 18 X 68
_TOLFEDINE_
_®_
_20 MG_
16 TABLETS
READ THE ATTACHED LEAFLET BEFORE
USING THIS PRODUCT.
DIRECTIONS FOR USE:
RESTRAINT
DO NOT USE IN FOOD PRODUCING ANIMALS.
Do not use in animals receiving corticosteroids or
others NSAIDS.
Do not use in animals suffering from cardiac
hepatic or renal disease, which show signs of
gastrointestinal ulceration or evidence of blood
dyscrasia.
Use
in
animal
under
6
weeks
of
age
is
not
recommended.
DOSAGE AND ADMINISTRATION
4 mg Tolfenamic acid/kg of bodyweight once
daily for 3 to 5 days. Each 20 mg tablet treats
5.0 kg of bodyweight.
TOLFEDINE
®
Tablets may be used as an alternative
to TOLFEDINE
®
Injectable (APVMA 40464).
A suggestred administration regime is an initial
treatment with TOLFEDINE
®
Injectable followed
by TOLFEDINE
®
Tablets on subsequent days.
FIRST
AID:
If
poisoning
occurs,
contact
a
doctor or Poisons Information Centre.
_Phone Australia 131126; New Zealand 0800 764 766._
444741 0616 B
APVMA 62918/20mg/1208
STORE below 25°C (Air Conditioning)
DISPOSE of empty containers by wrapping with paper and putting in
garbage.
Refer to the Safety Data Sheet before use.
PRESCRIPTION
ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_TOLFEDINE® 20 MG_
TOLFENAMIC ACID 20 MG/TABLET
A NON-STEROIDAL
ANTI-INFLAMMATORY FOR
USE IN CATS AND DOGS
16 TABLETS
Distributed by:
VETOQUINOL AUSTRALIA PTY LTD
Unit 302/2, 6-12 Boronia Road,
DaVinci Business Park,
Brisbane Airport, Qld, 4008
Phone: 1800 032 355
sales.australia@vetoquinol.com
Manufactured by:
VETOQUINOL S.A.,
MAGNY VERNOIS,
70200 Lure (France)
ETUI TOLF 20MG 16CPS AU 444741 0616 B L_ETUI TOLF 20MG 16CPS. 06/02/17
11:35 Page1
APPROVED NON-RLP
AMENDMENT MADE
_T_
_OLFEDINE_
_20 MG_
TABLETS - COMPRIMIDOS - TABLETTER
ACIDUM TOLFENAMICUM - TOLFENAMIC ACID 20 MG
ORAL USE - VÍA ORAL - VIA ORALE - ORALE ANWENDUNG
FOR VETERINARY USE
USO VETERINARIO - FÖR DJUR - TIL DYR
_®_
_T_
_OLFEDINE_
_20 MG_
COMPRIMÉS - TABLETTEN - TABLETKI
COMPRESSE - TABLETY
ACIDUM TOLFENAMICUM - TOLFENAM
Read the complete document
Summary of Product characteristics
PRODUCT NAME: TOLFEDINE 20 MG
PAGE: 1 OF 5
THIS VERSION ISSUED: OCTOBER, 2015
SAFETY DATA SHEET
Issued by: Vetoquinol Australia Pty Ltd
Phone: 1800 032 355
(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: 1800 032 355 (BUSINESS HOURS)
UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK,
FAX: 1800 648 460
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 20 MG
OTHER NAMES:
Tolfenamic acid 20mg/tablet
APVMA CODE:
62918
PRODUCT USE:
Non steroidal anti-inflammatory for use in cats and 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 SWALLOWED
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