BUTE PASTE ORAL ANTI-INFLAMMATORY AND ANALGESIC FOR HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

PHENYLBUTAZONE

Available from:

RANVET PTY. LIMITED

INN (International Name):

phenylbutazone(200mg/mL)

Pharmaceutical form:

ORAL PASTE

Composition:

PHENYLBUTAZONE ANALGESIC Active 200.0 mg/ml

Units in package:

100mL; 150mL; 1L; 20mL; 30mL; 500mL; 80mL

Class:

VM - Veterinary Medicine

Therapeutic group:

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat: NOT TO BE USED in horses in tended for human consumption.; Host/pest details: HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, MUSCULOSKELETAL CONDITIONS, SOFT TISSUE INJURY]; PONY: [ANALGESIC, ANTI-INFLAMMATORY AGENT, MUSCULOSKELETAL CONDITIONS, SOFT TISSUE INJURY]; An aid in the treatment of musculo-skeletal conditions and soft tissue injuries in horses where anti-inflammatory, antipyretic and analgesic activity would be beneficial.Do not administer to horses with a history of cardiac, renal or hepatic disorders, or when gastro-intestinal tract ulceration or blood dyscrasias are present or suspected. See Precautions and Contra-Indications on label.

Authorization status:

Registered

Authorization date:

2022-07-01

Patient Information leaflet

J
R
Pt
L d
anvet
ty
t
BUTE PASTE
Oral
Anti-Inflammatory
and
Analgesic for
Date:
November 19,
Horses
2002
Version:
4
Page
I
of!
C/N : 000
Immediate
Container
Label
_Anything above this line is_
_not_
_draft_ /_ text label._
PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUT
OF
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
BUTEPASTE
Oral
Anti-Inflammatory
and
Analgesic for Horses
Active
constituent:
Phenylbutazone
200mg/ml
An
aid in the treatment
of
musculo-skeletal
conditions and soft tissue injuries in horses where anti-inflammatory,
antipyretic and analgesic activity would be beneficial.
20rrtL,
30rrtL,
80rrtL,
500rrtL,
IL
DIRECTIONS FOR USE
Precautions
and
Contra-indications
Do not
administer to horses
with a history
of
cardiac,
_renal_
or hepatic disorders,
or when gastro-intestinal
tract
ulceration or
blood
dyscrasias
are
present
or
suspected.
Discontinue
therapy If
signs
of
lethargy,
colic,
diarrhoea,
inappetance, oral
ulceration or vascular disorders resulting in ventral
oedema occur during treatment.
Foals or pony breeds
may
have a greater risk
of
toxicity than horses and care should be taken to adhere to the
recommended dose rates in these animals.
Therapy in ponies should be discontinued
ifno
response is seen after
4-5 days of treatment.
Dosage
and
administration:
Administer paste orally 30 minutes prior to feeding.
Horses
(450 kg):
10 mL (2 g PBZ) twice on first day,
then 5 mL (1 g PBZ) twice daily for 4 days,
then 5
mL
(l
g PBZ) daily or every second day as required or as directed by a vet.
Ponies (225kg):
5
ml,
(l
g PBZ) daily for 4 days,
then 2.5 mL
(\'2
g PBZ) daily or
every
second
day
as required
or as directed by a vet.
MEAT
WITH~OLDING
PE~I~D:
NOT
TO
B~
USEI?_~n
horses
intended
for
human
consumption.
If
used in performance animals,
the regulations
of
the relevant
authorities regarding medication should be
observed.
Dispose
of
empty container by wrapping with paper and putting in garbage.
Store below 30° C (room temperature).
Ranvet Pty Ltd,
10-12 Green St, BotanyNSW 2019 Australia.
TOLL FREE 1800 727 217 Tel,
02

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Summary of Product characteristics

RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)
ChemWatch Material Safety Data Sheet
CHEMWATCH 4966-74
For Workplace - Small Volume Use Only.
Issue Date: 5-MAR-2008
CD 2004/3 Page 1 of 9
Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
PRODUCT NAME
RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)
SYNONYMS
PRODUCT USE
For animal treatment only. Anti-inflammatory, analgesic and
antipyretic oral paste for
relief of painful musculoskeletal conditions in horses.
SUPPLIER
Company: Ranvet Pty Ltd ACN 001 606 033
Address:
10-12 Green Street
East Botany
NSW 2019
AUS
Telephone: +61 2 9666 1744
Emergency Telephone: +61 418 493 533 A/H
Fax: +61 2 9666 1755
Section 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
NON-HAZARDOUS SUBSTANCE. NON-DANGEROUS GOODS.
According to the Criteria of NOHSC, and the ADG Code.
POISONS SCHEDULE
S4
RISK
Ingestion may produce health damage*.
Cumulative effects may result following exposure*.
May produce discomfort of the eyes*.
Limited evidence of a carcinogenic effect*.
* (limited evidence)
SAFETY
Wear eye/face protection.
Take off immediately all contaminated clothing.
In case of contact with eyes, rinse with plenty of water and contact
Doctor or
Poisons Information Centre.
continued...
RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)
ChemWatch Material Safety Data Sheet
CHEMWATCH 4966-74
For Workplace - Small Volume Use Only.
Issue Date: 5 - MAR - 2008
CD 2004/3 Page 2 of 9
Section 2 - HAZARDS IDENTIFICATION ...
If you feel unwell contact Doctor or Poisons Information Centre. (Show
the label
if possible).
Section 3 - COMPOSITION / INFORMATION ON INGREDIENTS
NAME
CAS RN
%
phenylbutazone
50-33-9
20
additives nonhazardous
>60
Section 4 - FIRST AID MEASURES
SWALLOWED
- If swallowed do NOT induce vomiting.
- If vomiting occurs, lean patient forward or place on left side
(head-down
position, if possible) to maintain open airway and prevent aspiration.
- Observe the patient carefully.
- Never give liquid to a person showing signs of being sleepy or with
reduced
awa

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