PRILIUM 150 MG
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
20-06-2017
Summary of Product characteristics
(SPC)
20-06-2017
Active ingredient:
IMIDAPRIL HYDROCHLORIDE
Available from:
Vetoquinol Australia Pty Ltd
INN (International Name):
imidapril HCl(170.45mg/g)
Pharmaceutical form:
ORAL SOLUTION/SUSPENSION
Composition:
IMIDAPRIL HYDROCHLORIDE ANTI-HYPERTENSIVE Active 5.0 mg/ml
Units in package:
150mg
Class:
VM - Veterinary Medicine
Therapeutic group:
DOG | BITCH | CASTRATE | PUPPY
Therapeutic area:
CARDIOVASCULAR SYSTEM
Therapeutic indications:
CARDIAC FAILURE | HEART FAILURE
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [CARDIAC FAILURE]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CARDIAC FAILURE]; For treatment of moderate to severe heart failure caused by mitral regurgitation or by dilated cardiomyopathy in dogs.NOT TO BE USED in food producing species of animals. See contraindications on leaflet.
Authorization status:
Stopped
Authorization date:
2021-07-01
Patient Information leaflet
150
mg
PRESCRIPTION ANIMAL
REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
_P_
_RILIUM 150 MG_
FIRST AID INSTRUCTIONS
If poisoning occurs, contact a doctor or
Poisons Information Centre. Phone Australia
131126.
SAFETY DIRECTIONS
May irritate the eyes. Avoid contact with the
eyes. Wash hands after use.
Manufactured by:
VETOQUINOL S.A.,
MAGNY VERNOIS,
70200 Lure (France)
Distributed by:
VETOQUINOL AUSTRALIA PTY LTD
Unit 302/2, 6-12 Boronia Road,
DaVinci Business Park,
Brisbane Airport, Qld, 4008
Phone: 1800 032 355
sales.australia@vetoquinol.com
APVMA N°: 58986/1205
DISPOSAL
Dispose of empty container by wrapping in
paper and putting in garbage.
STORAGE CONDITIONS
BEFORE RECONSTITUTION:
Store below 25°C
(air conditioning).
AFTER RECONSTITUTION: Store between 2°C and
8°C (refrigerate. Do not freeze).
SEE BOTTOM FLAP FOR BATCH AND EXPIRY
441516 0715 B
150
mg
_P_
_RILIUM 150 MG_
FOR TREATMENT OF MODERATE TO SEVERE HEART
FAILURE CAUSED BY MITRAL REGURGITATION OR BY
DILATED CARDIOMYOPATHY IN DOGS
NET CONTENTS: 0.880 g (containing 150 mg
Imidapril hydrochloride) 2mL graduated syringe
_P_
_RILIUM 150 MG_
_P_
_RILIUM 150 MG_
_P_
_RILIUM 150 MG_
READ THE ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
Discard
unused
portion
within
77
days
(11 weeks) after reconstitution.
RESTRAINTS:
NOT TO BE USED IN FOOD-
PRODUCING SPECIES OF ANIMALS.
CONTRAINDICATIONS AND SIDE EFFECTS
See leaflet
PREPARATION OF THE SOLUTION:
See Leaflet
DOSAGE
: The recommended dose of imidapril
hydrochloride for dogs weighing more than
4 Kg is 0.25 mg/Kg once a day per oral route,
i.e. 0.05 mL/Kg of reconstituted PRILIUM
150 mg (1mL/20Kg).
ADMINISTRATION:
Unscrew the cap, introduce
the graduated syringe into the applicator, turn
the assembly upside down and measure the
quantity
to
administer
using
the
syringe
graduated in Kg. The product can be administered
either directly into the mouth of the animal on
an empty stomach or during the meals, or on
food. Once the product has been administered,
replac
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Summary of Product characteristics
PRODUCT NAME: PRILIUM 150MG
PAGE: 1 OF 5
THIS VERSION ISSUED: OCTOBER, 2015
SAFETY DATA SHEET
Issued by: Vetoquinol Australia Pty Ltd
Phone: 1800 032 355
(BUSINESS HOURS)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
VETOQUINOL AUSTRALIA PTY LTD
PHONE: 1800 032 355 (BUSINESS HOURS)
UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK,
FAX: 1800 648 460
BRISBANE AIRPORT, QLD 4008
CHEMICAL NATURE:
Imidapril is in a class of medicines called angiotensin-converting
enzyme (ACE)
inhibitors, that can relieve high blood pressure
TRADE NAME:
PRILIUM 150MG
APVMA CODE:
58986
PRODUCT USE:
For the treatment of moderate to severe heart failure caused by mitral
regurgitation or
dilated cardiomyopathy in dogs.
CREATION DATE:
OCTOBER, 2015
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
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 Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S15, S22, S36, S24/25. Keep away from heat. Do not breathe dust. Wear
suitable protective
clothing. Avoid contact with skin and eyes.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: In case of fire, use carbon dioxide, dry chemical, foam,
water fog.
STORAGE
P411: Store at temperatu
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