MEDETATE INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MEDETOMIDINE HYDROCHLORIDE

Available from:

JUROX PTY LIMITED

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; 20mL; 50mL

Class:

VM - Veterinary Medicine

Therapeutic group:

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

Therapeutic area:

ANAESTHETICS/ANALGESICS

Therapeutic indications:

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

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ANALGESIC, SEDATIVE]; DOG: [ANALGESIC, SEDATIVE]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANALGESIC, SEDATIVE]; DOG: [ANALGESIC, SEDATIVE]; For use as a sedative and analgesic in the restraint of dogs and cats.NOT TO BE USED in food producing species of animals.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
MEDETATE INJECTION
65829/130868
Label Name:
MEDETATE INJECTION
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 a registered veterinarian.
For use as a sedative and analgesic in the restraint of dogs and cats.
PHARMACOLOGY
Medetomidine, 4[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole, is a
potent, selective and
specific alpha-2 adrenoceptor agonist. Alpha-2 adrenoceptor activation
by medetomidine
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.
A transient change in the conductivity of the heart muscle may occur,
as evidenced
by atrioventricular blocks and bradycardia. In the periphery,
medetomidine causes
vasoconstriction by activating postsynaptic alpha-2 adrenoceptors in
the vascular smooth
muscle. Thus the blood pressure initially increases after medetomidine
injection due to an
increase in systemic vascular resistance. The pressure reverts to
normal or slightly below
within 1 to 2 hours. Respiratory responses may include an initial
slowing of respiration
within a few seconds to 1–2 minutes after administration, increasing
to normal within 120
minutes. An initial decrease in tidal volume is followed by an
increase.
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
medetomidine and cyclohexamine compounds such as ketamine, and between
medetomidine and opiate drugs such as fentanyl, producing deep
anaesthesia. Similarly
medetomidine has a very potent ability to reduce dose requirements of
intravenous and
inhalation anaesthetics.
Medetomidine is rapidly absorbed after intramuscular injection. Peak
concentration is
reached within 15-20 min

Summary of Product characteristics

MEDETATE INJECTION
Page 1 of 4
continued
ISSUED:
7 MARCH 2014
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
MEDETATE INJECTION
PRODUCT CODE:
504275 (10 mL)
RECOMMENDED USE:
For use as a sedative and analgesic in the restraint of 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:
NOT HAZARDOUS ACCORDING TO GHS CRITERIA
RISK PHRASES:
None.
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Medetomidine hydrochloride
86347-15-1
0.1 %
Other ingredients determined to be not hazardous
To 100%
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 airway is clear and apply resuscitation. If breathing
is difficult, give oxygen.
Seek medical assistance immediately.
INGESTION:
Is unlikely to present an ingestion hazard. If swallowed, DO NOT
induce vomiting. Rinse
mouth. Keep subject warm and at rest. For advice, contact a doctor or
the National Poisons
Centre on 13 1126.
SKIN:
If skin contact occurs, wash affected area thoroughly with plenty of
soap and water for at least
20 minutes. If skin irritation or rash occurs, get medical
advice/attention.
EYE:
If eye contact occurs, rinse cautiously with water for at least 20
minutes. Continue rinsing.
Ensure complete irrigation of th

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
MEDETATE
®
Injection
ACTIVE CONSTITUENTS
Medetomidine hydrochloride 1 mg/mL
ACTIONS
Medetomidine is a potent, selective and specific alpha-2 adrenoceptor
agonist. Alpha-2 adrenoceptor activation by medetomidine
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, medetomidine
causes vasoconstriction by activating postsynaptic alpha-2
adrenoceptors in the vascular smooth muscle. Thus the blood pressure
initially increases after medetomidine injection due to an
increase in systemic vascular resistance. 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 medetomidine
and cyclohexamine compounds such as ketamine, and between medetomidine
and opiate drugs such as fentanyl, producing deep
anaesthesia. Similarly medetomidine has a very potent ability to
reduce dose requirements of intravenous and inhalation anaesthetics.
Medetomidine is rapidly absorbed after intramuscular injection. Peak
concentration is reached within 15-20 minutes. It is readily
metabolised and excreted in the urine and in the faeces (half lives of
elimination ranging from 1 to 1.6 hours).
INDICATIONS
For use as a sedative and analgesic in the restraint of dogs and cats.
Dogs: A sedative and analgesic for use in the restraint of dogs for
clinical examinations and procedures, minor surgery and
pre-anaesthesia.
Cats: A sedative for restraint.
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
DOSAGE AND ADMINISTRATION
Once broached, the product must b