DEXDOMITOR 0.5 MG/ML INJECTABLE SEDATIVE AND ANALGESIC FOR DOGS AND CATS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

DEXMEDETOMIDINE HYDROCHLORIDE

Available from:

JUROX PTY LIMITED

INN (International Name):

dexmedetomidine HCl(0.5mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

DEXMEDETOMIDINE HYDROCHLORIDE Active 0.5 mg/ml

Units in package:

10 mL

Class:

VM - Veterinary Medicine

Manufactured by:

JUROX

Therapeutic group:

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

Therapeutic area:

ANAESTHETICS/ANALGESICS

Therapeutic indications:

ANALGESIC | PRE-ANAESTHETIC | RESTRAINT | SEDATIVE | ANAESTHETIC PREMEDICANT | ANTIPYRETIC | COLIC | MUSCLE RELAXANT | SEDATIVE | SPASMOLYTIC

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ANALGESIC, PRE-ANAESTHETIC, RESTRAINT, SEDATIVE]; DOG: [ANALGESIC, PRE-ANAESTHETIC, RESTRAINT, SEDATIVE]; Sedative, analgesic for use in the restraint of dogs & cats.NOT TO BE USED in food producing species of animals. Contraindicated for use in puppies less than 6 months, or kittens less than 5 months of age. Refer to product leaflet also.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

DEXDOMITOR 0.5 MG/ML INJECTABLE SEDATIVE AND ANALGESIC FOR DOGS AND
CATS
64563/110169
Product Name:
APVMA Approval No:
Label Name:
DEXDOMITOR 0.5 MG/ML INJECTABLE SEDATIVE AND ANALGESIC FOR DOGS AND
CATS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
0.5 mg/mL DEXMEDETOMIDINE HYDROCHLORIDE
Claims:
Sedative, analgesic for use in the restraint of dogs and cats.
INDICATIONS:
Dogs:
- Non-invasive, mildly to moderately painful procedures and
examinations which require
restraint, sedation and analgesia;
- Deep sedation and analgesia in concomitant use with butorphanol for
medical and minor
surgical procedures;
- Premedication before induction and maintenance of general
anaesthesia.
Cats:
- Non-invasive, mildly to moderately painful procedures and
examinations which require
restraint, sedation and analgesia;
- Premedication before induction and maintenance of general
anaesthesia with ketamine.
Net Contents:
10mL
Directions for Use:
Restraints:
NOT TO BE USED in food producing species of animals.
Contraindications:
This product is contraindicated for use in puppies less than 6 months
of age, or kittens less
than 5 months of age. RLP APPROVED
The safety of dexmedetomidine has not been established during
pregnancy and lactation
in the target animal species. Therefore, the use of DEXDOMITOR 0.5
MG/ML during
pregnancy and lactation is not recommended. DEXDOMITOR 0.5 MG/ML
should not be
used in conjunction with sympathomimetic amines.
Precautions:
Use with caution in animals with cardiovascular, respiratory, liver or
kidney disease;
hypotension; shock or in poor general health. Ensure a thorough
risk-benefit analysis is
conducted before use in these animals.
The concomitant use of other CNS depressants should be expected to
potentiate the
depressant effects of either product, and appropriate dose adjustments
should be
made. Due to the potent pharmacological activity of dexmedetomidine,
skin contact with
DEXDOMITOR 0.5 MG/ML solution should be avoided

Summary of Product characteristics

DEXDOMITOR 0.5 mg/mL INJECTION
Page 1 of 6
Issued by: Jurox Pty Limited
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
ISSUED:
13 FEBRUARY 2018
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
DEXDOMITOR 0.5 MG/ML INJECTABLE SEDATIVE
AND ANALGESIC FOR DOGS AND CATS
PRODUCT IDENTIFIER:
0.5 mg/mL Dexmedetomidine hydrochloride
PRODUCT CODE:
520370 (10 mL)
RECOMMENDED USE:
Sedative, analgesic for use in the restraint of dogs and cats.
RESTRICTIONS ON USE:
For animal treatment only.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street,
Rutherford, NSW 2320,
Australia
CUSTOMER CENTRE:
1800 023 312
EMAIL:
[e-mail]
NATIONAL POISONS INFORMATION CENTRE:
13 1126 (24 hours)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9am – 5pm, Monday to Friday)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS: This product has been assessed according
to GHS and is classified as non-
hazardous.
GHS LABEL ELEMENTS:
Signal Word:
None.
Pictograms:
None.
Precautionary Statements:
None.
OTHER HAZARDS:
Dexmedetomidine is a potent α2 adrenoreceptor agonist. May cause
decrease in blood pressure (hypotension), sedation, slow breathing,
fainting
(syncope) and decreased salivation.
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Dexmedetomidine hydrochloride
145108-58-3
0.5%
Ingredients not contributing to the hazards
-
> 90%
DEXDOMITOR 0.5 mg/mL INJECTION
Page 2 of 6
Issued by: Jurox Pty Limited
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 4: FIRST AID MEASURES
GENERAL INFORMATION: Persons with known hypersensitivity to the active
substance or any of the excipients
should administer the product with caution. 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/a

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
Dexdomitor is a registered trademark of Orion Corporation
TECHNICAL NOTES
REGISTERED NAME
Dexdomitor® Injectable Sedative and Analgesic for Dogs and Cats
ACTIVE CONSTITUENTS
Dexmedetomidine hydrochloride 0.5 mg/mL.
ACTIONS
Dexmedetomidine is a potent, selective and specific alpha-2
adrenoceptor agonist. Alpha-2 adrenoceptor activation by
dexmedetomidine induces a dose-dependent decrease in the release and
turnover of noradrenaline in the central nervous system,
which is manifested as sedation, analgesia and bradycardia. In the
periphery, dexmedetomidine causes vasoconstriction by activating
postsynaptic alpha-2 adrenoceptors in the vascular smooth muscle.
Thus, the blood pressure initially increases after dexmedetomidine
injection due to an increase in systemic vascular resistance. The
increased blood pressure results in a compensatory, physiological
bradycardia. The pressure reverts to normal or slightly below within 1
to 2 hours. The respiratory frequency may transiently be lowered.
The duration and degree of the sedative and analgesic effects depend
on the dose administered. During maximal effect the
animal is relaxed, lies down and does not react to external stimuli.
Marked synergistic effects have been demonstrated between
dexmedetomidine and cyclohexamine compounds such as ketamine, and
between dexmedetomidine and opiate drugs such as
butorphanol, producing deep anaesthesia. Similarly, dexmedetomidine
has a very potent ability to reduce dose requirements of
intravenous and inhalation anaesthetics.
As a lipophilic compound, dexmedetomidine is well absorbed after
intramuscular injection. Dexmedetomidine is also rapidly
distributed in the body and penetrates the blood-brain barrier
readily. According to studies in rats, the maximum concentration in
the central nervous system is several times that of the corresponding
concentration in plasma. In the circulation, dexmedetomidine is
largely bound to plasma proteins (>90%).
DEXDOMITOR
®
Injection
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