PRILIUM 75 MG

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

IMIDAPRIL HYDROCHLORIDE

Available from:

Vetoquinol Australia Pty Ltd

INN (International Name):

imidapril HCl(93.17mg/g)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

IMIDAPRIL HYDROCHLORIDE ANTI-HYPERTENSIVE Active 2.5 mg/ml

Units in package:

75mg

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

CARDIOVASCULAR SYSTEM

Therapeutic indications:

CARDIAC FAILURE | CONGESTIVE HEART FAILURE | DILATED CARDIOMYOPATHY | HEART FAILURE | MITRAL AND/OR TRICUSPID REGUR | VALVULAR INSUFFICIENCY

Product summary:

Poison schedule: 4; Withholding period: WHP:N/A; Host/pest details: DOG: [CARDIAC FAILURE, CONGESTIVE HEART FAILURE]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CARDIAC FAILURE, CONGESTIVE HEART 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:

2019-06-30

Patient Information leaflet

Product Name: Prilium 75 mg
Label: Primary pack (carton) – Main Panel
Text appearing above the Header and below the Footer lines is not
included in the label
_ _
July 2016
Version 1
Page 1 of 8
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
PRILIUM 75 MG
2.5 MG/ML IMIDAPRIL HYDROCHLORIDE
Powder for 30 mL oral solution
For treatment of moderate to severe heart failure caused by mitral
regurgitation or by dilated
cardiomyopathy in dogs.
Net Contents: 0.805 g (containing 75 mg Imidapril hydrochloride), 2 mL
graduated syringe
30 mL
APPROVED NON-RLP
AMENDMENT MADE
Product Name: Prilium 75 mg
Label: Primary pack (carton) – Ancillary Panels
Text appearing above the Header and below the Footer lines is not
included in the label
_ _
July 2016
Version 1
Page 2 of 8
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 imadapril hydrochloride for dogs
weighing more than
2 kg is 0.25 mg/kg once a day per oral route, i.e. 0.1 mL/kg of
reconstituted PRILIUM 75
mg (1 mL/10 kg).
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, replace the cap onto the vial and rinse the syringe with
water. Store the vial
in the fridge.
FIRST AID: If poisoning occurs, contact a doctor or Poisons
Information Centre. Phone
Australia 131 126.
SAFETY DIRECTIONS: May irritate the eyes. Avoid contact with the eyes.
Wash hands
after use.
DISPOSAL: Dispose of container by wrapping in paper and putting in
garbage.
STOR

Summary of Product characteristics

PRODUCT NAME: PRILIUM 300MG, 150MG & 75MG
PAGE: 1 OF 5
THIS REVISION 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:
imidazolidine derivative.
TRADE NAME:
PRILIUM 300MG, 150MG & 75MG
OTHER NAMES:
This SDS is intended for products differing only in concentration of
active ingredient.
PRODUCT USE:
Animal (dog) pharmaceutical product used in the treatment of heart
failure in dogs.
CREATION DATE:
OCTOBER, 2008
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:
Xi, Irritating. Hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R36. Irritating to eyes.
SAFETY PHRASES:
S22, S25, S36, S45. Do not breathe dust. Avoid contact with eyes. Wear
suitable protective
clothing. In case of accident or if you feel unwell, contact a doctor
or Poisons Information Centre immediately (show
this SDS where possible).
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
GHS SIGNAL WORD: WARNING.
HAZARD STATEMENT:
H227: Combustible liquid.
H320: Causes eye irritation.
PREVENTION
P102: Keep out of reach of children.
P264: Wash contacted areas thoroughly after handling.
P280: Wear protective gloves, protective clothing and eye or face
protection.
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.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if
present and easy to do. Continue