TORBUGESIC BUTORPHANOL TARTRATE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

BUTORPHANOL BASE AS BUTORPHANOL TARTRATE; BENZETHONIUM CHLORIDE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

butorphanol as tartrate(10mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

BUTORPHANOL BASE AS BUTORPHANOL TARTRATE ALKALOID Active 10.0 mg/ml; BENZETHONIUM CHLORIDE AMMONIUM-QUATERNARY Other 0.1 mg/ml

Units in package:

10mL; 50mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

Therapeutic area:

ANAESTHETICS/ANALGESICS

Therapeutic indications:

Product summary:

Poison schedule: 8; Withholding period: WHP: Meat withholding period (horses): Do not administer later than 28 days b efore slaughter for human consumption.; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL, ANALGESIC]; DOG: [ANAESTHETIC - LOCAL/GENERAL, ANALGESIC]; HORSE: [ANALGESIC]; Analgesic and sedative for use in horses, dogs and cats.Not be administered to horses or dogs with a history of liver disease. This product should not be used in breeding horses, weanlings or foals.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
PRODUCT NAME:
TORBUGESIC BUTORPHANOL TARTRATE
ELABEL APPLICATION NO:
DC14-98862375E37
APVMA APPROVAL NO:
50128/101943
PRODUCT NO:
50128
VERSION NO:
6.0
APPLICATION STARTED:
2015-Feb-24 12:08:25
VERSION CREATED:
2015-Sep-08 13:58:46
STARTED BY:
CALC-
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PRINTED:
2015-Sep-08 13:59:04
LABEL NAME:
TORBUGESIC BUTORPHANOL TARTRATE
SIGNAL HEADINGS:
CONTROLLED DRUG
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
POSSESSION WITHOUT AUTHORITY ILLEGAL
CONSTITUENT
STATEMENTS:
Contains 10 mg/ml BUTORPHANOL BASE AS BUTORPHANOL TARTRATE
Not more than 0.1 mg/ml BENZETHONIUM CHLORIDE added as a preservative
CLAIMS:
Analgesic and sedative for use in horses, dogs and cats
NET CONTENTS:
10mL
50mL
DIRECTIONS FOR USE:
TORBUGESIC should not be mixed with any other product in the same
syringe.
CONTRAINDICATIONS:
CONTRAINDICATIONS:
Before using any combinations consult the contraindications which
appear on the other
products’ data sheets.
Horse: TORBUGESIC should not be administered to horses with a history
of liver disease.
There are no well controlled studies using butorphanol in breeding
horses, weanlings or
foals. Therefore the drug should not be used in these groups.
When used in combination with detomidine hydrochloride, do not use in
pregnant animals
nor in animals suffering from colic. Routine cardiac auscultation
should be performed prior
to use of this combination. Do not use the combination in horses with
a pre-existing cardiac
dysrhythmia or bradycardia.
Dog: TORBUGESIC should not be administered to dogs with a history of
liver disease. RLP APPROVED
For Official Use Only
Cat: TORBUGESIC is not recommended for intravenous use in cats under 5
kg body
weight.
PRECAUTIONS:
PRECAUTIONS:
TORBUGESIC, a potent analgesic should be used with caution with other
sedative or
analgesic drugs as these are likely to produce ad

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Summary of Product characteristics

PRODUCT NAME: TORBUGESIC® BUTORPHANOL TARTRATE
PAGE: 1 OF 5
THIS REVISION ISSUED: JULY, 2012
SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: 1800 814 883
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Pfizer Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: 1800 814 883
Fax: (02) 9850 3399
____________________________________
PFIZER AUSTRALIA PTY LTD
A.B.N. 50 008 422 348
CHEMICAL NATURE:
Butorphanol is a morphinan-type synthetic opioid. It is presented here
in aqueous
solution.
TRADE NAME:
TORBUGESIC
® BUTORPHANOL TARTRATE
APVMA CODE:
50128
PRODUCT USE:
Analgesic and sedative for use in horses, dogs and cats.
CREATION DATE:
JULY, 2012
THIS VERSION ISSUED:
JULY, 2012
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:
Not Hazardous - No criteria found.
SUSMP CLASSIFICATION:
S8
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: Clear, colourless liquid.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F
F
F
E
E
E
C
C
C
T
T
T
S
S
S
NOTE: DIFFERENT HAZARD ASSESSMENT CRITERIA OF SWA AND TGA MAY RESULT
IN SEEMING INCONSISTENCIES BETWEEN
MSDS AND LABEL. EFFECTS DESCRIBED IN THIS MSDS RELATE TO SHORT TERM
EMERGENCY SITUATIONS, SUCH AS ACCIDENTS
AND SPILLS WITH THE POTENTIAL FOR GROSS OVEREXPOSURE, AND TO LONG TERM
INDUSTRIAL AND MANUFACTURING EXPOSURE.
SEE PRODUCT LABEL FOR ASSE

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