Prilocard 5 mg tablets for dogs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

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Prenos Lastnosti izdelka (SPC)
12-06-2017

Aktivna sestavina:

Ramipril

Dostopno od:

aniMedica GmbH

Koda artikla:

QC09AA05

INN (mednarodno ime):

Ramipril

Odmerek:

5 mg/tablet

Farmacevtska oblika:

Tablet

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Dogs

Terapevtsko območje:

ramipril

Terapevtske indikacije:

Cardiovascular

Status dovoljenje:

Authorised

Datum dovoljenje:

2012-07-13

Lastnosti izdelka

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Prilocard 5 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substance:
Ramipril 5 mg
Excipients:
red ferric oxide 0.20 mg (E172)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
5 mg tablets.
Pink capsule-shaped biconvex tablets scored on one side of the tablet
and imprinted with 'B'
and '50'
on either side of
the scoring line.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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.
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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