Vasotop 1.25 mg Tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

Ramipril

Beschikbaar vanaf:

MSD Animal Health UK Limited

ATC-code:

QC09AA05

INN (Algemene Internationale Benaming):

Ramipril

farmaceutische vorm:

Tablet

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Dogs

Therapeutisch gebied:

Cardio Vascular ACE inhibitor

Autorisatie-status:

Expired

Autorisatie datum:

1999-02-25

Productkenmerken

Revised: February 2021
AN: 01810/2021
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vasotop 1.25 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each tablet contains ramipril 1.25mg
Excipients:
For full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
Beige oblong flavoured tablet with dark spots, half scored on both
sides with
embossing of “V” and “1.25” on both sides of score line.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of congestive heart failure (NYHA: decompensation
grades
II-IV). The product can be used in combination with diuretics, and the
cardiac
glycosides digoxin or methyl-digoxin.
4.3
CONTRAINDICATIONS
Not to be used in haemodynamically relevant vascular stenosis (e.g.
aortic
stenosis) or obstructive hypertrophic cardiomyopathy.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The use of ACE inhibitors in dogs with hypovolaemia/dehydration (e.g.
due to
large
doses
of
a
diuretic,
vomiting
or
diarrhoea)
can
lead
to
acute
hypotension. In such cases the fluid and electrolyte status should
first be
balanced and treatment suspended until it is stabilised.
This also applies if clinical signs of apathy or ataxia occur during
treatment
with the product (potential signs of hypotension). After these
symptoms have
subsided, the treatment should be continued at 50% of the original
dose.
Substances that deplete blood volume, such as diuretics, or which
vasodilate,
such as angiotensin-converting enzyme (ACE) inhibitors, may contribute
to
Revised: February 2021
AN: 01810/2021
Page 2 of 8
lowering
systemic
blood
pressure.
This
may
result
in
pre-renal
uraemia
(azotaemia). Renal function should be monitored both before and seven
days
after commencement of treatment with ACE inhibitors. This also applies
when
the dosage of ACE inhibitor or of a concurrently administered diuretic
is
increased. It is advisable to periodically monitor renal function
thro