Amodip 1.25 mg Chewable Tablets for Cats

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Amlodipine

متاح من:

Ceva Animal Health Ltd

ATC رمز:

QC08CA01

INN (الاسم الدولي):

Amlodipine

الشكل الصيدلاني:

Chewable tablet

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Cats

المجال العلاجي:

Cardio Vascular

الوضع إذن:

Authorized

تاريخ الترخيص:

2015-04-28

خصائص المنتج

Revised: September 2022
AN: 01544/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amodip 1.25 mg chewable tablets for Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
ACTIVE SUBSTANCE:
Amlodipine
1.25 mg
(Equivalent to 1.73 mg of amlodipine besilate)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
Oblong in shape, score line on one side, beige to light brown tablets.
Tablets can be divided into two equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of systemic hypertension in cats.
4.3
CONTRAINDICATIONS
Do not use in the case of cardiogenic shock and severe aortic
stenosis.
Do not use in cases of severe hepatic failure.
Do not use in cases of known hypersensitivity to the active substance
or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The primary cause and/or co-morbidities of hypertension, such as
hyperthyroidism,
chronic kidney disease and diabetes, should be identified and treated.
In cats situational hypertension (also called white coat hypertension)
occurs as a
consequence of the in-clinic measurement process in an otherwise
normotensive
animal. In case of high stress levels measurement of systolic blood
pressure may
Revised: September 2022
AN: 01544/2022
Page 2 of 7
lead
to
incorrect
diagnosis
of
hypertension.
It
is
recommended
that
stable
hypertension is confirmed by repeated measurement of systolic blood
pressure on
different days before commencing therapy.
Continued administration of the product over an extended period of
time should be in
accordance with an ongoing benefit/risk evaluation, performed by the
prescribing
veterinarian that includes measurement of systolic blood pressure
routinely during
treatment (e.g. every 6 to 8 weeks).
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
Special caution is required in patients with hepatic disease as
amlod