VASOTOP 5 ACE INHIBITOR TABLETS FOR DOGS

Land: Ástralía

Tungumál: enska

Heimild: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Virkt innihaldsefni:

RAMIPRIL

Fáanlegur frá:

INTERVET AUSTRALIA PTY LIMITED

INN (Alþjóðlegt nafn):

ramipril(5mg/Tb)

Lyfjaform:

ORAL TABLET

Samsetning:

RAMIPRIL ANTI-HYPERTENSIVE Active 5.0 mg/Tb

Einingar í pakka:

10x14(140); 2x14 (28); Tablets

Tegund:

VM - Veterinary Medicine

Framleitt af:

INTERVET AUSTRALIA

Meðferðarhópur:

DOG | BITCH | CASTRATE | PUPPY

Lækningarsvæði:

CARDIOVASCULAR SYSTEM

Ábendingar:

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

Vörulýsing:

Poison schedule: 4; Withholding period: WHP: n/a; Host/pest details: DOG: [CONGESTIVE HEART FAILURE]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CONGESTIVE HEART FAILURE]; For the treatment of congestive heart failure (NYHA decompensation grades II-IV).Not to be used in haemodynamically relevant stenoses (e.g. Aortic stenosis, mitral valve stenosis) or obstructive hypertrophic cardiomyopathy.

Leyfisstaða:

Registered

Leyfisdagur:

2023-07-01

Upplýsingar fylgiseðill

REGISTERED PRODUCT NAME:
VASOTOP 5 ACE INHIBITOR TABLETS FOR DOGS
PAGE 1 OF 6
PACK SIZES: 28 TABLETS & 140 TABLETS
DATE (VERSION CONTROL): 16/04/02
DESCRIPTION: CARTON TEXT
NRA: 53528/0602
PANEL LABELS, TEXT ABOVE THE HEADER AND BELOW THE FOOTER ARE NOT
INCLUDED IN THIS LABEL TEXT.
PRESCRIPTION ANIMAL REMEDY
Info
PEST
9
Verified
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
VASOTOP
® 5
ACE INHIBITOR TABLETS FOR DOGS
5 mg RAMIPRIL/TABLET
For the treatment of congestive heart failure (NYHA decompensation
grades II-IV) [2 X 14 (28) SCORED TABLETS
10 X 14 (140) SCORED TABLETS]
REGISTERED PRODUCT NAME:
VASOTOP 5 ACE INHIBITOR TABLETS FOR DOGS
PAGE 2 OF 6
PACK SIZES: 28 TABLETS & 140 TABLETS
DATE (VERSION CONTROL): 16/04/02
DESCRIPTION: CARTON TEXT
NR
A: 53528/0602
PANEL LABELS, TEXT ABOVE THE HEADER AND BELOW THE FOOTER ARE NOT
INCLUDED IN THIS LABEL TEXT.
INDICATIONS
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.
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
DOSAGE AND ADMINISTRATION
The therapeutic dose in the dog is a single daily oral administration
of 0.125 mg
ramipril per kg (1 VASOTOP 5 tablet per 40 kg).
In patients treated concurrently with VASOTOP 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
Store below 25
°
C (Air Conditioning)
Dispose of empty container by wrapping with paper and placing in
garbage.
[B]
Expiry:
NRA Approval No.: 53528 / 0602
Manufactured in Germany and sold and marketed in Australia by:
Intervet Australia Pty Ltd
A.B.N. No. 79 008 467 034
91-105 Harpin Street
Bendigo East
Victoria 3550
REGISTERED PRODUCT NAME:
VASOTOP 5 ACE INHIBITOR TABLETS FOR DOGS
PAGE 3 OF 6
PACK SIZES: 28 SCORED TABLETS & 140 SCORED TABLETS
DATE (VERSION CONTROL): 16/

Vara einkenni

PRODUCT NAME: VASOTOP (1.25, 2.5 & 5) ACE INHIBITOR TABLETS FOR
DOGS
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 6
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 (1.25, 2.5 & 5) ACE INHIBITOR TABLETS FOR DOGS
ACE is and acronym for Angiotensin-Converting Enzyme.
PRODUCT CODE:
709403, 709404, 709405
RECOMMENDED USE:
For the treatment of congestive heart failure in dogs.
APVMA NO:
53526, 53527, 53528
CREATION DATE:
November, 2006
THIS VERSION ISSUED:
July, 2009
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:
No 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