Vidalta 10 mg Prolonged-release Tablets for Cats

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: VMD (Veterinary Medicines Directorate)

Aktīvā sastāvdaļa:

Carbimazole

Pieejams no:

MSD Animal Health UK Limited

ATĶ kods:

QH03BB01

SNN (starptautisko nepatentēto nosaukumu):

Carbimazole

Zāļu forma:

Prolonged-release tablet

Receptes veids:

POM-V - Prescription Only Medicine – Veterinarian

Ārstniecības grupa:

Cats

Ārstniecības joma:

Anti Hormone Agent

Autorizācija statuss:

Authorized

Autorizācija datums:

2007-12-21

Produkta apraksts

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