Prilocard 1.25 mg tablets for dogs

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Ramipril

Beschikbaar vanaf:

aniMedica GmbH

ATC-code:

QC09AA05

INN (Algemene Internationale Benaming):

Ramipril

Dosering:

1.25 mg/tablet

farmaceutische vorm:

Tablet

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutische categorie:

Dogs

Therapeutisch gebied:

ramipril

therapeutische indicaties:

Cardiovascular

Autorisatie-status:

Authorised

Autorisatie datum:

2012-07-13

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Prilocard 1.25 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substance:
Ramipril 1.25 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
White round biconvex tablets, imprinted with ‘B’ on one side of
the tablet and ‘48’ on the other.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of congestive heart failure (equivalent to New York
Heart Association [NYHA] classes II,
III and IV)
caused by valvular
insufficiency due to endocardiosis or
cardiomyopathy.
The preparation may if
applicable be
administered concomitantly with furosemide (diuretic) and/or the
cardiac glycosides digoxin or methyl digoxin.
In patients treated concomitantly with ramipril and furosemide, the
diuretic dose may be reduced to achieve the same
diuretic effect as in treatment with furosemide alone.
4.3 CONTRAINDICATIONS
Do not
use in haemodynamically-related stenoses (e.g.
aortic stenosis,
mitral
stenosis)
nor
in cases of
obstructive
hypertrophic cardiomyopathy.
Do not use in cases of hypersensitivity to the active substance,
ACE-inhibitors or to any of the excipient(s).
See Section 4.7 for use in Pregnancy and Lactation
Class
Clinical symptoms
II
Fatigue, dyspnoea, cough etc. seen in normal activity.
Ascites may occur at this stage.
III
Comfortable at rest, but capacity for activity minimal.
IV
Incapable of any activity.
Clinical symptoms of disablement occur even at rest.
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