DOMITOR SEDATIVE AND ANALGESIC FOR DOGS AND CATS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MEDETOMIDINE HYDROCHLORIDE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

medetomidine HCl(1mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

MEDETOMIDINE HYDROCHLORIDE IMIDAZOLE Active 1.0 mg/ml

Units in package:

10mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY

Therapeutic area:

ANAESTHETICS/ANALGESICS

Therapeutic indications:

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

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ANALGESIC]; DOG: [ANALGESIC]; Sedative, analgesic for use in the restraint of dogs and cats.NOT to be used in food producing species of animals. Use of this product is not recommended in pregnant animals. This product should NOT be used in conjunction with sympathomimetic amines.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

DOMITOR SEDATIVE AND ANALGESIC FOR DOGS AND CATS
40613/134463
Product Name:
APVMA Approval No:
Label Name:
DOMITOR SEDATIVE AND ANALGESIC FOR DOGS AND CATS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
1 mg/mL medetomidine hydrochloride
Claims:
For use only by or under supervision of a registered veterinarian.
[Carton only]
Sedative, analgesic for use in the restraint of dogs and cats.
[Vial label]
Sedative and analgesic for dogs and cats.
[Leaflet]
Dogs: Sedative, analgesic for use in the restraint of dogs for
clinical examinations and
procedures, minor surgery and pre-anaesthesia.
Cats: Sedative for restraint.
Net Contents:
10 mL
Directions for Use:
Restraints:
DO NOT USE in food-producing species of animals.
Contraindications:
DOMITOR should not be used in conjunction with sympathomimetic amines.
Precautions:
The use of DOMITOR in pregnancy has not been monitored in sufficient
animals and is,
therefore, not recommended.
Care should be taken with the use of DOMITOR in animals with
cardiovascular, respiratory,
liver and kidney disease, hypotension, shock or in poor general
health. RLP APPROVED
The concomitant use of other CNS depressants should be expected to
potentiate the
depressant effects of either product; therefore, dose should be
adjusted accordingly.
Due to the potent pharmacological activity of medetomidine, skin
contact with DOMITOR
solution should be avoided. Wipe off excessive spillage on skin of
animals.
Side Effects:
Due to the mechanism of action of DOMITOR, heart rate and body
temperature decrease
in both dogs and cats. Treated animals should be kept warm in an even
temperature for
12 hours after sedation. Blood pressure will initially increase and
then return to normal, or
slightly below. This is accompanied by a compensatory decrease in
heart rate.
Some dogs and most cats will vomit 5 to 10 minutes after injection,
and some cats may
also vomit at the time of recovery.
Occasional muscle-jerking in limbs has been observ

Summary of Product characteristics

PRODUCT NAME: DOMITOR® STERILE INJECTABLE SOLUTION
PAGE: 1 OF 5
This revision issued: October, 2015
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
CHEMICAL NATURE:
Active ingredient is a synthetic alpha-2-adrenoreceptor agonist with
sedative and
analgesic properties.
TRADE NAME:
DOMITOR
® STERILE INJECTABLE SOLUTION
OTHER NAMES:
Medetomidine hydrochloride sterile injectable solution
PFIZER MSDS CODE:
MSDS105
PRODUCT USE:
Sedative/analgesic; alpha-2-adrenergic agonist agent.
CREATION DATE:
DECEMBER, 2006
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid until March, 2017.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xn, Harmful. Not classified as hazardous according to the criteria of
SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R22. Harmful if swallowed.
SAFETY PHRASES:
S20, S37, S45, S24/25. When using, do not eat or drink. Wear suitable
gloves. In case of accident
or if you feel unwell, contact a doctor or Poisons Information Centre
immediately (show this MSDS where possible).
Avoid contact with skin and eyes.
SUSMP CLASSIFICATION:
S4
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:
harmful if swallowed.
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
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmfu