Vidalta 10 mg Prolonged-release Tablets for Cats

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: VMD (Veterinary Medicines Directorate)

सक्रिय संघटक:

Carbimazole

थमां उपलब्ध:

MSD Animal Health UK Limited

ए.टी.सी कोड:

QH03BB01

INN (इंटरनेशनल नाम):

Carbimazole

फार्मास्यूटिकल फॉर्म:

Prolonged-release tablet

प्रिस्क्रिप्शन प्रकार:

POM-V - Prescription Only Medicine – Veterinarian

चिकित्सीय समूह:

Cats

चिकित्सीय क्षेत्र:

Anti Hormone Agent

प्राधिकरण का दर्जा:

Authorized

प्राधिकरण की तारीख:

2007-12-21

उत्पाद विशेषताएं

Revised: August 2020
AN: 00299/2020
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vidalta 10 mg prolonged-release tablets for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains:
ACTIVE SUBSTANCE:
Carbimazole
10.0 mg
EXCIPIENTS:
Red ferric oxide (E172)
0.25 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
Round, pink tablet with little spots.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of hyperthyroidism and hyperthyroidism-associated clinical
signs in cats.
4.3
CONTRAINDICATIONS
Do not use in cats suffering from concurrent systemic diseases, such
as severe primary
liver disease or diabetes mellitus.
Do not use in cats showing signs of auto-immune diseases and/or
altered red or white
blood cell counts, such as anaemia, neutropaenia or lymphopaenia.
Revised: August 2020
AN: 00299/2020
Page 2 of 9
Do
not
use
in
cats
with
platelet
disorders
(particularly
thrombocytopaenia)
or
coagulopathies.
Do not use in cats with hypersensitivity to mercaptoimidazoles such as
carbimazole or
thiamazole (methimazole) or to any of the excipients.
Please refer to section 4.7.
4.4
SPECIAL WARNINGS FOR THE TARGET SPECIES
Thiamazole
(methimazole),
the
active
metabolite
of
carbimazole,
inhibits
thyroid
hormone production and therefore cessation of treatment with
carbimazole will result in
a rapid (within 48 hours) return to pre-treatment thyroid hormone
levels. Chronic
administration is therefore necessary unless surgical or
radiation-induced thyroidectomy
is performed.
A small proportion of cats with thyroid adenoma may fail to respond or
have a poor
response to treatment.
Thyroid
carcinoma
is
a
rare
cause
of
hyperthyroidism
in
the
cat
and
medical
management alone is not recommended in such cases as it is not
curative.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Treatment should be adjusted according to a benefi