Felidale 2.5 mg Coated Tablets for Cats

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Thiamazole

זמין מ:

Dechra Limited

קוד ATC:

QH03BB02

INN (שם בינלאומי):

Thiamazole

טופס פרצבטיות:

Coated tablet

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Cats

איזור תרפויטי:

Anti Hormone Agent

מצב אישור:

Authorized

תאריך אישור:

2012-05-01

מאפייני מוצר

Revised: August 2018
AN: 02223/2017
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Felidale 2.5 mg Coated Tablets for Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
ACTIVE SUBSTANCE:
Thiamazole 2.5 mg
EXCIPIENTS:
Titanium Dioxide (E171) 1.12 mg
Erythrosine (E127) 0.01 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet.
Pink sugar-coated biconvex tablets, 5.5 mm diameter.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the stabilisation of hyperthyroidism in cats prior to surgical
thyroidectomy.
For the long-term treatment of feline hyperthyroidism.
4.3
CONTRAINDICATIONS
Do not use in cats suffering from systemic disease such as primary
liver
disease or diabetes mellitus.
Do not use in cats showing signs of autoimmune disease.
Do not use in animals with disorders of white blood cells, such as
neutropaenia and lymphopaenia.
Do not use in animals with platelet disorders and coagulopathies
(particularly
thrombocytopaenia).
Do not use in cats with hypersensitivity to thiamazole or the
excipient,
polyethylene glycol.
Do not use in pregnant or lactating females.
Please refer to section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Revised: August 2018
AN: 02223/2017
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
As thiamazole can cause haemoconcentration, cats should always have
access to drinking water.
If more than 10 mg per day is required animals should be monitored
particularly carefully.
Use of the product in cats with renal dysfunction should be subject to
careful
risk : benefit assessment by the clinician. Due to the effect
thiamazole can
have on reducing the glomerular filtration rate, the effect of therapy
on renal
function should be monitored closely as deterioration of an underlying
condition may occur.
Haematology must be monitored due to risk of leucopaenia or haemolytic
anaemia.
Any animal that suddenly a