VASOTOP P 1.25MG ACE INHIBITOR TABLETS FOR DOGS AND CATS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

RAMIPRIL

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

ramipril(1.25mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

RAMIPRIL ANTI-HYPERTENSIVE Active 1.25 mg/Tb

Units in package:

28 Tablets

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

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

Therapeutic area:

CARDIOVASCULAR SYSTEM

Therapeutic indications:

CONGESTIVE HEART FAILURE | HYPERTENSION | DILATED CARDIOMYOPATHY | ELEVATED SYSTOLIC BLOOD PRESSU | MITRAL AND/OR TRICUSPID REGUR | VALVULAR INSUFFICIENCY

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [HYPERTENSION]; DOG: [CONGESTIVE HEART FAILURE]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [HYPERTENSION]; DOG: [CONGESTIVE HEART FAILURE]; For the treatment of congestive heart failure (NYHA decompensation grades II-IV) in dogs, and as an aid for the treatment of elevated systolic blood pressure and associated clinical signs in cats.NOT for use in haemodynamically relevant stenoses (eg aortic stenosis, mitral valve stenosis) or obstructive hypertrophic cardiomyopathy. As safe use in pregnancy and lactation has not been established, the product should NOT be used in pregnant and suckl

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

REGISTERED PRODUCT NAME:
VASOTOP P 1.25
ACE INHIBITOR TABLETS FOR DOGS AND CATS
PAGE 1 OF 7
PACK SIZES: 28 SCORED TABLETS
DATE (VERSION CONTROL):22 /06/2011 V2
DESCRIPTION: CARTON TEXT
APVMA: 61561/46606
PANEL LABELS, TEXT ABOVE THE HEADER AND BELOW THE FOOTER ARE NOT
INCLUDED IN THIS LABEL TEXT.
_MAIN PANEL _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
VASOTOP
® P 1.25MG
ACE INHIBITOR TABLETS FOR DOGS AND CATS
1.25 mg RAMIPRIL/TABLET
For the treatment of congestive heart failure (NYHA decompensation
grades II-IV) in dogs,
and as an aid for the treatment of elevated systolic blood pressure
and associated clinical
signs in cats. 28 SCORED TABLETS RLP APPROVED
Info
PEST


Verified
REGISTERED PRODUCT NAME:
VASOTOP P 1.25
ACE INHIBITOR TABLETS FOR DOGS AND CATS
PAGE 2 OF 7
PACK SIZES: 28 SCORED TABLETS
DATE (VERSION CONTROL):22 /06/2011 V2
DESCRIPTION: CARTON TEXT
APVMA: 61561/46606
PANEL LABELS, TEXT ABOVE THE HEADER AND BELOW THE FOOTER ARE NOT
INCLUDED IN THIS LABEL TEXT.
_ANCILLARY PANELS_
_ _
INDICATIONS
Dogs: For the treatment of congestive heart failure (NYHA
decompensation grades II-IV), also
in combination with the diuretic frusemide and/or the cardiac
glycosides digoxin or
methidigoxin.
Cats: A
s an aid for the treatment of elevated systolic blood pressure
(between 160 and 230
mmHg) and associated clinical signs in cats.
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
DOSAGE AND ADMINISTRATION:
The therapeutic dose in the dog and cat is a single daily oral
administration of 0.125
mg ramipril per kg (1 VASOTOP
®
P 1.25 tablet per 10 kg).
In patients treated concurrently with VASOTOP
®
P and frusemide the dose of the
diuretic can be reduced to achieve the same diuretic effect as
treatment with
frusemide alone.
FIRST AID:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia
131126
DISPOSAL:
Dispose of empty container by wrapping with paper and placing in
garbage.
STORAGE:
Store below 25
°
C (Air conditioning)
[B

Summary of Product characteristics

PRODUCT NAME: VASOTOP P (1.25, 2.5 & 5) ACE INHIBITOR TABLETS
FOR DOGS
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JANUARY, 2010
PAGE: 1 OF 5
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: [phone]
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Ramipril is a prodrug and is converted to the active metabolite
Ramiprilat by liver
esterase enzymes. It is presented in a suitable tabletting blend of
ingredients.
TRADE NAME:
VASOTOP P (1.25, 2.5 & 5) ACE INHIBITOR TABLETS FOR DOGS
ACE is an acronym for Angiotensin-Converting Enzyme.
RECOMMENDED USE:
For the treatment of congestive heart failure in dogs.
APVMA NO:
61561, 61556, 61530
CREATION DATE:
January, 2010
THIS VERSION ISSUED:
January, 2010
and is valid for 5 years from this date.
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:
S22, S45. Do not breathe dust. In case of accident or if you feel
unwell, contact a doctor or Poisons
Information Centre immediately (show the label where possible).
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Oblong tablets, half scored on one side; white (1.25), yellow (2.5),
red (5).
ODOUR:
Beef flavour and odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
INHALATION:
SHORT TERM EXPOSURE:
Long term inhalation of high amounts of any nuisance dust may overload
lung clearance
mechanism. Available data indicates that this product is not harmful.
In addition product is unlikely to cause any
discomfort or irritation.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that