Felimazole 2.5 mg Coated Tablets for Cats

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Thiamazole

Verfügbar ab:

Dechra Limited

ATC-Code:

QH03BB02

INN (Internationale Bezeichnung):

Thiamazole

Darreichungsform:

Coated tablet

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Cats

Therapiebereich:

Anti Hormone Agent

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2004-11-19

Fachinformation

Revised: November 2021
AN: 00273/2021 & 00277/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Felimazole 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
Sodium methyl parahydroxybenzoate (E219)
0.0034 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
neutropenia and
lymphopenia.
Do not use in animals with platelet disorders and coagulopathies
(particularly
thrombocytopenia).
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.
Revised: November 2021
AN: 00273/2021 & 00277/2021
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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 leucopenia or haemolytic
anaemia.
Any animal that suddenly appears unwe