BUTOMIDOR INJECTION
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
Safety Data Sheet
(SDS)
15-10-2001
Active ingredient:
BUTORPHANOL BASE AS BUTORPHANOL TARTRATE; BENZETHONIUM CHLORIDE
Available from:
AUSRICHTER 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
Therapeutic group:
CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH
Therapeutic area:
ANALGESIC+MUSCULOSKELETAL
Therapeutic indications:
ANAESTHETIC - LOCAL/GENERAL | ANALGESIC | PRE-ANAESTHETIC | ANAESTHETIC PREMEDICANT | ANTIPYRETIC | COLIC | GENERAL ANAESTHETIC | IMMOBILISER | LOCAL ANAESTHETIC | MUSCLE RELAXANT | PREMEDICATION | SEDATIVE | SPASMOLYTIC | TRANQUILLISER | TRAVEL SICKNESS
Product summary:
Poison schedule: 8; Withholding period: WHP: MEAT: Horses: Do not use less than 28 days before slaughter for human co nsumption.; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL, ANALGESIC, PRE-ANAESTHETIC]; DOG: [ANAESTHETIC - LOCAL/GENERAL, ANALGESIC, PRE-ANAESTHETIC]; HORSE: [ANALGESIC]; Poison schedule: 8; Withholding period: ; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL, ANALGESIC, PRE-ANAESTHETIC]; DOG: [ANAESTHETIC - LOCAL/GENERAL, ANALGESIC, PRE-ANAESTHETIC]; HORSE: [ANALGESIC]; Analgesic and sedative for use in horses, dogs and cats only.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
Butomidor Injection draft label
03/12/01
54095 10mL, 50mL
Version 3 page 1 of 7
_Main panel - bottle _
CONTROLLED DRUG
POSSESSION WITHOUT AUTHORITY ILLEGAL
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
BUTOMIDOR INJECTION
CONTAINS 10MG/ML BUTORPHANOL BASE
AS BUTORPHANOL TARTRATE
Contains not more than 0.1mg/mL Benzethonium Chloride as a
preservative
ANALGESIC AND SEDATIVE FOR USE IN HORSES, DOGS AND CATS ONLY
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
AUSRICHTER PTY LTD
10ML [50ML]
MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE LESS THAN 28 DAYS BEFORE
SLAUGHTER
FOR HUMAN CONSUMPTION.
NRA Approval No. 54095/1001
Store below 25°C (air conditioning). Protect from light.
Vial should be discarded 28 days after opening.
[B]
Exp.
Info
PEST
Verified
Butomidor Injection draft label
03/12/01
54095 10mL, 50mL
Version 3 page 2 of 7
_Main panel – carton front and back _
CONTROLLED DRUG
POSSESSION WITHOUT AUTHORITY ILLEGAL
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
BUTOMIDOR INJECTION
CONTAINS 10MG/ML BUTORPHANOL BASE
AS BUTORPHANOL TARTRATE
Contains not more than 0.1mg/mL Benzethonium Chloride as a
preservative
ANALGESIC AND SEDATIVE FOR USE IN HORSES, DOGS AND CATS ONLY
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
AUSRICHTER PTY LTD
10ML [50ML]
Butomidor Injection draft label
03/12/01
54095 10mL, 50mL
Version 3 page 3 of 7
_Ancillary panel 1 – carton side _
For animals under 10kg bodyweight, administration by insulin syringe
is recommended. Great care
should be taken when administering BUTOMIDOR to animals weighing under
5kg as low volumes
are used.
DOSAGE
Vial should be discarded 28 days after opening. Protect from light.
Dogs: 0.01-0.03mL BUTOMIDOR per 1kg bodyweight (IM, SC or IV)
Cats: 0.01-0.04mL BUTOMIDOR per 1kg bodyweight (IM, SC or IV)
Horses: 0.2-1.0mL BUTOMIDOR per 100kg bodyweight (IV)
MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE LESS THAN 28 DAYS BEFORE
SLAUGHTER
FOR HUMAN CONSUMPTION.
_Ancillary panel 2 – carton side _
DISPOSAL
Dispose of empty container by wrappin
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Summary of Product characteristics
PRODUCT NAME: BUTOMIDOR INJECTION
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:
Butorphanol is a morphinan-type synthetic opioid. It is presented here
in water
solution.
TRADE NAME:
BUTOMIDOR INJECTION
PRODUCT USE:
Analgesic and sedative for use in horses, dogs and cats; for use as
described on the
product label.
CREATION DATE:
SEPTEMBER, 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:
Xi, Irritating. Hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R36. Irritating to eyes.
SAFETY PHRASES:
S36, S45, S24/25. Wear suitable protective clothing. 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:
S8
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
GHS SIGNAL WORD: WARNING.
HAZARD STATEMENT:
H227: Combustible liquid.
H320: Causes eye irritation.
PREVENTION
P102: Keep out of reach of children.
P264: Wash contacted areas thoroughly after handling.
P280: Wear protective gloves, protective clothing and eye or face
protection.
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.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if
present and easy to do. Continue rinsing.
P332+P313: If skin irritation occurs: Ge
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Safety Data Sheet
Ausrichter Pty Ltd
ABN 79 000 908 529
2/21 Chester Street, Camperdown NSW 2050
Telephone: (02) 9517 1166
Fax: (02) 9516 5810
Email: ausrichter@bigpond.com
_Animal Health Products_
REDUCES FEAR, STRESS AND ADVERSE BEHAVIOUR
3
●
IMPROVES PATIENT HANDLING
●
PRE AND POST SURGERY ANALGESIA
●
PROLONGS AND DEEPENS ANALGESIA
●
PREDICTABLE, RELIABLE SEDATION
BUTOMIDOR
™
INJECTION
Butorphanol (as tartrate) 10 mg/mL
A SYNTHETIC OPIOID AGONIST-ANTAGONIST ANALGESIC
ANALGESIC, SEDATIVE & TRANQUILLIZER FOR
HORSES, DOGS & CATS
MODE OF ACTION
Butorphanol tartrate is a synthetic opioid agonist –
antagonist analgesic and sedative._ At higher doses it is_
_analgesic and at a lower dose it has a predictable_
_sedative effect._ It has competitive antagonist activity at
the _µ_-receptors , and agonist activity at - and -
receptors. It produces its effect by binding to opioid
receptors.
1
The -receptors (kappa opioid receptors) mediate
analgesia (primary spinal) with little depression of
ventilation, sedation and miosis. Opioid agonists-
antagonist drugs (butorphanol) act at the -receptors.
9
The receptors bind with opioid agonists in a
sterospecific manner. Upon attaching to the receptors
the agonist induces a conformational change in the
receptors which leads to a biochemical alteration in the
neurons containing the receptors.
2
Analgesia is produced by the activation of kappa and
mu opioid receptors resulting in a unique
pharmacological profile compared to other opioid
agonists. Butorphanol can be administered before
during or after medical or surgical procedures to reduce
pain without fear of inducing significant
cardiopulmonary effects.
5
The potency of butorphanol is _approximately 5 times_
_stronger that that of morphine_.
1
ANALGESIA – SEDATION –
TRANQUILLIZATION
Analgesia and sedation is essential for effective
restraint, handling and treatment of animals
particularly horses. Analgesia is important if fear, stress
and adverse behavior is to be prevented. In horses
butorphanol may be administered with or wit
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