BUTORDYNE INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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; 20mL; 50ml

Class:

VM - Veterinary Medicine

Therapeutic group:

CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH

Therapeutic area:

ANAESTHETICS/ANALGESICS

Therapeutic indications:

ANALGESIC | ANTIPYRETIC | COLIC | MUSCLE RELAXANT | SEDATIVE | SPASMOLYTIC

Product summary:

Poison schedule: 8; Withholding period: WHP: N/A; Host/pest details: CAT: [ANALGESIC]; DOG: [ANALGESIC]; HORSE: [ANALGESIC]; Poison schedule: 8; Withholding period: ; Host/pest details: CAT: [ANALGESIC]; DOG: [ANALGESIC]; HORSE: [ANALGESIC]; Analgesic and sedative for use in horses, dogs and cats.NOT to be used in horses intended for human consumption. NOT to be administered to horses or dogs with a history of liver disease. See RESTRAINTS, PRECAUTIONS etc on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

\
Butordyne® Injection labelling
MAY13
page 1/13
Vial label main panel
J
urox Pty Limited
CONTROLLED DRUG
POSSESSION WITHOUT AUTHORITY
ILLEGAL
KEEP OUT OF REACH
OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
BUTORDYNE®
Injection
Contains 10 mg
I
ml
butorphanol as butorphanol tartrate and
0.1
mg
I
ml
benzethonium chloride as preservative.
Analgesic
and sedative
for
use in horses,
dogs
and cats
[1
0
ml][20
ml][50
mL]
[Jurox
logo]
+
RLP
Approved
Butordyne® Injection labelling
MAY13
page 2/13
Vial label ancillary panel(s)
[10ml
and
20ml
only]
READ
THE
ENCLOSED
LEAFLET
BEFORE
USING
THIS
PRODUCT.
NOT
TO
BE
USED
in horses intended
for
human
consumption.
Jurox
Pty Limited
Store below 25'C (Air conditioning). Protect from
light.
Store
upright after initial broaching.
APVMA
No:
67699/60191
B.
EXP.
Vial label ancillary panel(s)
[50ml
only]
READ
THE
ENCLOSED
LEAFLET
BEFORE
USING
THIS
PRODUCT.
For animals under
10
kg
b.w.,
administration
by
insulin syringe
is
recommended.
Due
to
the low volumes involved, great care
should
be
taken
when
administering BUTORDYNE®
to
animals weighing under 5
kg.
DOSAGE AND ADMINISTRATION:
Discard unused portion
8
weeks after
first
broaching.
Dogs:
0.01
-0.03
ml
per 1
kg
b.w.
(IM,
SC
or
IV)
Cats:
0.01-
0.04
ml
per 1
kg
b.w.
(1M,
SC
or
IV)
Horses:
0.2-
1.0
ml
per
100
kg
b.w.
(IV)
MEAT WITHHOLDING PERIOD (HORSES): NOT
TO
BE
USED in horses intended
for
human consumption.
APVMA
No:
67699/:60191
Store below 25'C (Air conditioning). Protect from
light.
Store
upright after initial broaching.
Jurox
Pty Limited
85
Gardiner Street, Rutherford, NSW 2320, Australia
B.
EXP.
J urox
Pty
Limited
Butordyne® Injection labelling
MAYI3
page
_3113 _
Carton
Front
&
Back
Panel
CONTROLLED
DRUG
POSSESSION
WITHOUT
AUTHORITY
ILLEGAL
KEEP
OUT
OF
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
BUTORDYNE®
Injection
Contains
10
mg
I
mL
butorphanol as butorphanol tartrate and
0.1
mg
I
mL
benzethonium chloride
as
preservative.
Analgesic
and
sedative
for
use
in
horses,
dogs
and
cats
Uurox logo]
[1
0
mL][20
mL][50
mL]
Carton:
Side
1
READ

Summary of Product characteristics

BUTORDYNE INJECTION
Page 1 of 5
continued
ISSUED:
23 JANUARY 2017
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
BUTORDYNE INJECTION
PRODUCT CODE:
504270 (10 mL); 520355 (50 mL)
RECOMMENDED USE:
Analgesic and sedative for use in horses, dogs and cats.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 02 3312
NATIONAL POISONS INFORMATION CENTRE:
13 1126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 02 3312 (9a.m. – 5p.m.)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS:
STOT RE - CATEGORY 2
GHS PICTOGRAMS:
HEALTH HAZARD
SIGNAL WORD*:
WARNING
HAZARD STATEMENTS*:
May cause damage to organs through prolonged or repeated exposure.
PRECAUTIONARY STATEMENTS*:
PREVENTION
Do not breathe vapours.
RESPONSE
Get medical advice if you feel unwell.
DISPOSAL
Dispose of contents / container in accordance with local / national
regulations.
* N.B.: These statements are determined by Work Health and Safety
regulations and may not reflect Signal Headings and
First Aid and Safety statements on product labelling, which are
determined by a competent authority during assessment
for registration.
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Butorphanol tartrate
58786-99-5
< 1.5 %
Benzethonium chloride
121-54-0
0.01%
Other ingredients determined to be not hazardous
To 100%
BUTORDYNE INJECTION
Page 2 of 5
continued
SECTION 4: FIRST AID MEASURES
FIRST AID MEASURES:
Consult the National Poisons Centre on 13 1126 or a doctor immediately
in every case of
suspected chemical poisoning. Never give fluids or induce vomiting if
a patient is unconscious
or convulsing regardless of cause of injury. If medical
advice/attention is needed, have product
container or label at hand.
INHALATION:
Is unlikely to present an inhalation problem. If respiratory symptoms
do occur, remove patient
to fresh air. Lay patient down and keep warm and rested. If breathing
is shallow or has
stopped, ensure ai

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
BUTORDYNE
®
Injection
ACTIVE CONSTITUENTS
10 mg/mL butorphanol as butorphanol tartrate
0.1 mg/mL benzethonium chloride as preservative
PHARMACOLOGY
Butordyne® Injection (butorphanol tartrate) is a totally synthetic,
centrally acting narcotic agonist – antagonist analgesic with potent
antitussive activity. Butorphanol is an opioid κ -partial agonist and
a μ-antagonist. The effects of butorphanol last approximately 1- 3
hours. The duration of analgesia in dogs is < 1 hour and up to 2 - 3
hours in cats. Cardiopulmonary depressant effects are minimal after
treatment with butorphanol as demonstrated in dogs
1
, humans
2,3
and horses.
4
The cardiopulmonary effects of butorphanol are not
distinctly dosage-related but rather reach a ceiling effect beyond
which further dosage increases result in relatively lesser effects.
EQUINE PHARMACOLOGY: Following intravenous injection in horses,
butorphanol is largely eliminated from the blood within 3 to 4
hours. The drug is extensively metabolised in the liver and excreted
in the urine.
INDICATIONS
Analgesic and sedative for use in horses, dogs and cats.
In cats, sedation does not occur with Butordyne® Injection alone, but
can occur in dogs with Butordyne® Injection alone.
Butordyne® Injection may be used in combination with medetomidine
hydrochloride and ketamine hydrochloride as a triple
anaesthetic in dogs and cats.
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
DOSAGE AND ADMINISTRATION
Refer to the product leaflet for full dosage and administration
instructions.
HORSE
For analgesia: The recommended dosage is 0.1 mg of butorphanol per
kilogram of body weight (equivalent to 1 mL of Butordyne®
Injection for each 100 kg of body weight) administered by intravenous
injection. Butorphanol use should not exceed 48 hours in any
one treatment episode.
DOG
When administering intravenously, inject slowly: do not inject