DORMOSEDAN SEDATIVE/ANALGESIC FOR HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

DETOMIDINE HYDROCHLORIDE; METHYL PARAHYDROXYBENZOATE

Available from:

JUROX PTY LIMITED

INN (International Name):

detomidine HCl(10mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

DETOMIDINE HYDROCHLORIDE IMIDAZOLE Active 10.0 mg/ml; METHYL PARAHYDROXYBENZOATE UNGROUPED Other 1.0 mg/ml

Units in package:

5mL; Unit = 1mL

Class:

VM - Veterinary Medicine

Manufactured by:

JUROX

Therapeutic group:

HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL

Therapeutic area:

ANAESTHETICS/ANALGESICS

Therapeutic indications:

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

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat: Not to be used in horses th at may be slaughtered for human consump tion.; Host/pest details: HORSE: [ANALGESIC, SEDATIVE]; For mild to heavy sedation of horses; and for all analgesia, including colic.Contraindicated for use in pregnant mares. NOT TO BE USED in food producing species of animals.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

107110AU-9
Store below 25°C (Air conditioning).
Protect from light.
Exp. Date :
Batch No :
5 mL
5 mL
5 mL
Rapidly renders a horse easy to
handle prior to
•
MINOR SURGERY
•
MEDICATION
•
TREATMENT
•
EXAMINATION
•
TRAVEL etc.
STORAGE:
Store below 25°C (Air
conditioning). Protect from light.
IN-USE SHELF LIFE:
3 months from initial
broaching. Discard unused product
after this date
Dispose of empty vial by wrapping
with paper and putting in garbage.
APVMA Approval No. 37945/5mL/1206
PFIZER ANIMAL HEALTH
A division of Pfizer Australia Pty Ltd
38-42 Wharf Rd
West Ryde NSW 2114
CN3135A
® Reg. Trade Mark of
Orion Corporation, Finland.
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FO
R ANIMAL TREATMENT ONLY
SEDATIVE/ANALGESIC
FOR HORSES
10MG/ML
DETOMIDINE HYDROCHLORIDE
Fo
r mild to heavy sedation of
horses and for all analgesia,
in
cluding colic.
DEVELOPED AND MANUFACTURED BY:
READ THE ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
RESTRAINT: NOT TO BE USED IN
FOOD PRODUCING ANIMALS.
DOSAGE:
0.1 mL to 0.8 mL, I.M. or I.V. per
100 kg of bodyweight.
For I.M. or slow I.V. injection
MEAT WITHHOLDING PERIOD
(HORSES): NOT TO BE USED IN
HORSES INTENDED FOR HUMAN
CONSUMPTION.
CCaarrttoonn 3355 xx 3355 xx 7788 mmmm
APPROVED
LABEL
Info
PEST


Verified
0
1
-
U
A
1
9
1
7
0
1
READ ENCLOSED LEAFLET BEFORE
USING THIS PRODUCT.
RESTRAINT: NOT TO BE USED IN FOOD
PRODUCING ANIMALS
Dose: 0.1 to 0.8 mL/100 kg IM or IV.
APVMA: 37945/5mL/1206
Developed and manufactured by Orion
Corporation, Finland
Store below 25°C (Air conditioning).
Protect from light.
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5 mL
PRESCRIPTION ANIMAL REMEDY
FOR ANIMAL TREATMENT ONLY
SEDATIVE/ANALGESIC
FOR HORSES
DE
TOMIDINE
HYDROCHLORIDE 10 MG/ML
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APPROVED
LABEL
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Summary of Product characteristics

PRODUCT NAME: DORMOSEDAN® SEDATIVE/ANALGESIC FOR HORSES
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:
Detomidine is an imidazoline derivative alpha2-adrenergic agonist
TRADE NAME:
DORMOSEDAN
® SEDATIVE/ANALGESIC FOR HORSES
PRODUCT USE:
Veterinary sedative, administered as injection, for use as described
on the product
label.
CREATION DATE:
JULY, 2007
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid until December, 2017.
SECTION 2 – HAZARDS IDENTIFICATION
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:
S45, S24/25. 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
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PHYSICAL DESCRIPTION & COLOUR
: Clear, colourless liquid.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
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Detomidine can cause an initial rise in blood pressure which is then
followed by bradycardia and heart block. Also,
piloerection, sweating, salivation, slight muscle tremors, and penile
prolapse may all

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
Dormosedan is a registered trademark of Orion Corporation
TECHNICAL NOTES
REGISTERED NAME
Dormosedan® Sedative/analgesic for horses
ACTIVE CONSTITUENTS
Detomidine hydrochloride 10 mg/mL
DESCRIPTION
Dormosedan® is detomidine hydrochloride, a sedative/analgesic for
horses, with dose related effect.
INDICATIONS
Dormosedan is a dose controlled equine sedative and analgesic for all
indications including visceral pain. It is employed for facilitation
of examinations, X-rays, minor surgical operations, transport etc. and
for control of pain including that of the uncomplicated colic case.
Dormosedan has a role for the provision of prolonged analgesia for
example with the accident case.
METABOLISM AND EXCRETION
Dormosedan is evenly distributed in the body and rapidly penetrates
brain and CNS. Dormosedan is rapidly absorbed from the injection site
and evenly distributed. Site tolerance is high with minimal tissue
irritation.
Dormosedan is extensively metabolised and the metabolites excreted
principally in urine, with the average elimination half-life of 1.2
hours.
Therefore the retention of residues is very low, and 70-80 % of the
total dose is excreted from the body during two consecutive days.
DORMOSEDAN
®
Sedative/analgesic for horses
WWW.JUROX.COM.AU
Customer Service 1800 023 312
Dormosedan is a registered trademark of Orion Corporation
TECHNICAL NOTES
MODE OF ACTION
Dormosedan is an alpha-2 adrenoceptor agonist at central and
peripheral sites. Its central depressive action produces a decrease
in vigilance of the animal without any hypnotic effect. Dormosedan is
non-narcotic. It causes temporary blockage of pain impulses,
and reduces the level of consciousness resulting in heavy or deep
sedation, but does not produce unconsciousness. Animals treated
within the recommended range of doses remain standing, and seek a
well-balanced footing.
Dormosedan exerts its analgesic effect by inhibition of CNS-mediated
transmission of pain impulses and pain sensation.
Dormosedan’s a