Prilocard 5 mg Tablets for Dogs

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: VMD (Veterinary Medicines Directorate)

Aktif bileşen:

Ramipril

Mevcut itibaren:

aniMedica GmbH

ATC kodu:

QC09AA05

INN (International Adı):

Ramipril

Farmasötik formu:

Tablet

Reçete türü:

POM-V - Prescription Only Medicine – Veterinarian

Terapötik grubu:

Dogs

Terapötik alanı:

Cardio Vascular ACE inhibitor

Yetkilendirme durumu:

Expired

Yetkilendirme tarihi:

2012-07-18

Ürün özellikleri

Revised: March 2017
AN: 00126/2016
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prilocard 5mg 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.
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.
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.
Revised: March 2017
AN: 00126/2016
Page 2 of 7
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
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 h