Prilocard 1.25 mg Tablets for Dogs

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Ramipril

Dostupné s:

aniMedica GmbH

ATC kód:

QC09AA05

INN (Mezinárodní Name):

Ramipril

Léková forma:

Tablet

Druh předpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Dogs

Terapeutické oblasti:

Cardio Vascular ACE inhibitor

Stav Autorizace:

Expired

Datum autorizace:

2012-07-18

Charakteristika produktu

Revised: March 2017
AN: 00124/2016
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prilocard 1.25mg 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.
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.
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.
Revised: March 2017
AN: 00124/2016
Page 2 of 6
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
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
If symptoms of apathy and ataxia (potential symptoms of hypotension)
occur
during treatment with ramipril, administration of the preparation
should be stopped
and resumed at only 50% of the original dose as soon as the symptoms
hav