DOLOREX BUTORPHANOL TARTRATE INJECTABLE ANALGESIC FOR HORSES, DOGS AND CATS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

BUTORPHANOL BASE AS BUTORPHANOL TARTRATE

Available from:

INTERVET AUSTRALIA PTY LIMITED

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

Units in package:

10mL; 50mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

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:

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

Product summary:

Poison schedule: 8; Withholding period: WHP: MEAT(HORSES):Do not use less than 28 days before slaughter for human con sumption.; Host/pest details: CAT: [ANALGESIC]; DOG: [ANALGESIC]; HORSE: [ANALGESIC]; Poison schedule: 8; Withholding period: ; Host/pest details: CAT: [ANALGESIC]; DOG: [ANALGESIC]; HORSE: [ANALGESIC]; Injectable analgesic for horses, dogs and cats.Should not be administered to animals with a history of liver disease. Not advised for use in animals with lower respiratory infections. Safety in pregnant bitches/heartworm affected dogs has not been studied.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

33x33x65
353C, 328C
369
093774 CBU880
01
DOLOREX
TM
10 mL
CONTROLLED DRUG
POSSESSION WITHOUT AUTHORITY ILLEGAL
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ THE ENCLOSED
LEAFLET BEFORE USING
THIS PRODUCT.
DIRECTIONS FOR USE:
CONTRAINDICATIONS:
Dolorex™ should not be
administered to animals with a
history of liver disease.
Because Dolorex™ is cough
suppressive it is not advised
for use in animals with lower
respiratory infections.
The safety of Dolorex™ in
pregnant bitches or in dogs
affected with heartworm has
not been studied.
DOSAGE AND ADMINISTRATION:
Discard unused portion within
56 days of first broaching vial.
Horses:
Give 0.1 - 0.2 mg/kg body-
weight by intravenous
injection.
Dog & Cat:
Give 0.1-0.2 mg/kg
bodyweight by intravenous
injection; or 0.2-0.4 mg/kg
bodyweight by intramuscular
or subcutaneous injection.
MEAT WITHHOLDING
PERIOD (HORSES): DO NOT
USE LESS THAN 28 DAYS
BEFORE SLAUGHTER FOR HUMAN
CONSUMPTION.
FIRST AID:
If poisoning occurs, contact a
doctor or Poisons Information
Centre. Phone Australia
131126
APVMA Approval No.:
50392/10M/0108
DISPOSAL:
Dispose of empty container by
wrapping with paper and
putting in garbage.
STORAGE:
Store below 25°C
(Air conditioning).
INTERVET AUSTRALIA PTY LIMITED
91-105 Harpin Street
BENDIGO EAST VIC 3550
Phone: [phone]
Batch No.: / Expiry Date:
DOLOREX
TM
CONTROLLED DRUG
POSSESSION WITHOUT
AUTHORITY ILLEGAL
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
DOLOREX
TM
BUTORPHANOL TARTRATE INJECTABLE ANALGESIC FOR
HORSES, DOGS AND CATS
ACTIVE CONSTITUENT:
BUTORPHANOL BASE
(as tartrate) 10 mg/mL
10 ML
™
™
™
DOLOREX
TM
CONTROLLED DRUG
POSSESSION WITHOUT
AUTHORITY ILLEGAL
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
DOLOREX
TM
BUTORPHANOL TARTRATE INJECTABLE ANALGESIC FOR
HORSES, DOGS AND CATS
ACTIVE CONSTITUENT:
BUTORPHANOL BASE
(as tartrate) 10 mg/mL
10 ML
™
™
™
Batch No.: / Expiry Date:
Batch No.: / Expiry Date:
Print A4 = A4
Scale= 100%
Dimensions=33 x 33 x 65 mm
APPROVED
LABEL
Info
PEST


Verified
06705

Summary of Product characteristics

PRODUCT NAME: DOLOREX BUTORPHANOL TARTRATE INJECTABLE
ANALGESIC FOR HORSES, DOGS AND CATS
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 6
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: [phone]
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Sterile solution of butorphanol tartrate for injection.
TRADE NAME:
DOLOREX BUTORPHANOL TARTRATE INJECTABLE ANALGESIC FOR HORSES, DOGS
AND CATS
PRODUCT CODE:
50392
RECOMMENDED USE:
Centrally acting, narcotic agonist-antagonist analgesic. Veterinarian
Only drug for animal
treatment only - for analgesic injection for use in horses, dogs and
cats.
APVMA NO:
50392
CREATION DATE:
November, 2006
THIS VERSION ISSUED:
July, 2009
and is valid for 5 years from this date.
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:
S25, S45. Avoid contact with eyes. In case of accident or if you feel
unwell, contact a doctor or
Poisons Information Centre immediately (show the label where
possible).
SUSDP CLASSIFICATION:
S8
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Clear, colourless liquid.
ODOUR:
Characteristic odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
Butorphanol is a potent analgesic with appreciable narcotic antagonist
activity.
INFORMATION ON TOXICITY: This product has an 70-350X margin of safety.
Orally, 10mg/kg gives slight cardiovascular and
respiratory depression. In dogs a dose of 0.03-1mg/kg IV causes no
cardiovascular or respiratory effect. A dosage of
1mg/kg IV causes transient clonus / tremor.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. In addition
product