EQUISEDAN VET 10MG/ML SOLUTION FOR INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

DETOMIDINE HYDROCHLORIDE

Available from:

AUSRICHTER PTY LTD

INN (International Name):

detomidine HCl(10mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

DETOMIDINE HYDROCHLORIDE IMIDAZOLE Active 10.0 mg/ml

Units in package:

10mL

Class:

VM - Veterinary Medicine

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: MEAT WITHOLDING PERIOD:(HORSES): Not to be used in horses intended for human consumption.; Host/pest details: HORSE: [ANALGESIC, SEDATIVE]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [ANALGESIC, SEDATIVE]; Sedative/Analgesic for Horses. Rapidly renders a horse easy to handle prior to: minor surgery, medication, treatment, examination, travel etc. For mild to heavy sedation of horses; and for all analgesia including colic.NOT TO BE USED in food producing species of animal. Higher doses may cause sweating, diuresis & occasional slight tremors.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

EQUISEDAN VET 10ML CARTON
CODE:
61880_41771_10mL_carton_MPL_V1.PDF
SIZE:
Combined panel size – 120mm wide x 65mm high
Main front panel size – 30mm wide x 65mm high
SCALE:
100% when printed on A4 with page scaling set to NONE
CREATED:
6/2/09
EDITED:
14/4/09
COLOURS:
    CMYK
 DYELINE
READ THE ENCLOSED
LEAFLET BEFORE USING
THIS PRODUCT
DIRECTIONS FOR USE
Restraint
NOT TO BE USED in food
producing species of animal.
Rapidly renders a horse easy to
handle prior to
•   MINOR SURGERY
•   MEDICATION
•   TREATMENT
•   EXAMINATION
•   TRAVEL etc
For mild to heavy sedation of
horses; and for all analgesia
including colic.
Dosage and administration
0.1 mL to 0.8 mL, I.M or I.V. per
100 kg of bodyweight. For full
directions, see enclosed leaflet.
MEAT WITHHOLDING PERIOD (HORSES):
NOT TO BE USED in horses intended
for human consumption.
FIRST AID
If poisoning occurs, contact a
doctor or Poisons Information
Centre. Phone Australia 131126.
Dispose
of empty vial by wrapping
in paper and putting in garbage.
Store
below 25
°
C (Air conditioning).
Protect from light.
APVMA Approval No.: 61880/10mL/0109
Batch No.:
Expiry Date:
Australia
Distributed by:
Ausrichter Pty Ltd
ACN 000 908 529
2/21 Chester Street
Camperdown, NSW 2050
PRESCRIPTION
ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
EQUISEDAN
®
VET
10mg/mL Solution for Injection
DETOMIDINE 
HYDROCHLORIDE
10mg/mL
Sedative/Analgesic
for Horses
10mL
FOR I.M. OR I.V.
INJECTION
EQUISEDAN
®
VET
10mg/mL Solution
for Injection
PRESCRIPTION
ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
EQUISEDAN
®
VET
10mg/mL Solution for Injection
DETOMIDINE 
HYDROCHLORIDE
10mg/mL
Sedative/Analgesic
for Horses
10mL
FOR I.M. OR I.V.
INJECTION
APPROVED
LABEL
Info
PEST


Verified
EQUISEDAN VET IMMEDIATE CONTAINER
CODE:
61880_41771_10mL_immediate_MPL_V1.PDF
SIZE:
75mm wide x 30mm high
SCALE:
100% when printed on A4 with page scaling set to NONE
CREATED:
6/2/09
EDITED:
14/4/09
COLOURS:
  �

Summary of Product characteristics

PRODUCT NAME: EQUISEDAN VET 10MG/ML SOLUTION FOR INJECTION
PAGE: 1 OF 5
THIS VERSION ISSUED: AUGUST, 2013
SAFETY DATA SHEET
ISSUED BY: AUSRICHTER 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
AUSRICHTER PTY LTD
PHONE: [phone]
2/21 CHESTER ST
FAX: [phone]
CAMPERDOWN NSW 2050
[e-mail]
CHEMICAL NATURE:
Water solution of Detomidine hydrochloride; an imidazole derivative
and α2-
adrenergic agonist.
TRADE NAME:
EQUISEDAN VET 10MG/ML SOLUTION FOR INJECTION
APVMA CODE:
61880
PRODUCT USE:
A sedative/analgesic for use in horses as described on the product
label.
CREATION DATE:
NOVEMBER, 2012
THIS VERSION ISSUED:
AUGUST, 2013
and is valid for 5 years from this date.
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:
S24/25. 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
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
RESPONSE
P337: If eye irritation persists: seek medical attention.
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: In case of fire; Not Combustible. Use extinguishing media
suited to burning materials.
STORAGE
P402+P404: Store in a dry place. Store in a closed container.
P411+P235: Store at temperatures not exceeding 30°C. Keep cool.
DISPOSAL
P501: Dispose of contents and containers as specified on the
registered label.
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: A clear, almost colourless liquid.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
Symptoms of exposure seem to be limited to horses. T