Felimazole 5 mg Coated Tablets for Cats

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Thiamazole

Dostupno od:

Dechra Ltd

ATC koda:

QH03BB02

INN (International ime):

Thiamazole

Doziranje:

5 mg/tablet

Farmaceutski oblik:

Coated tablet

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapijska grupa:

Cats

Područje terapije:

thiamazole

Terapijske indikacije:

Miscellaneous

Status autorizacije:

Authorised

Datum autorizacije:

2008-11-28

Svojstava lijeka

Health Products Regulatory Authority
03 May 2018
CRN000X5X
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Felimazole 5 mg Coated Tablets for Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
Thiamazole 5 mg
EXCIPIENTS
Titanium Dioxide (E171) 0.495 mg
Beta-Carotene (E160a) 0.16 mg
For a full list of excipeints, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
Orange 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).
Health Products Regulatory Authority
03 May 2018
CRN000X5X
Page 2 of 7
Do not use in pregnant or lactating females.
Do not use in cats with hypersensitivity to thiamazole or the
excipient, polyethylene
glycol.
Please refer to section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
As thiamazole can cause haemoconcentration, cats should always have
access to
drinking water.
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 sudde