Thiafeline 5 mg Film-coated Tablets for Cats

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Thiamazole

Tilgængelig fra:

Le Vet Beheer B.V.

ATC-kode:

QH03BB02

INN (International Name):

Thiamazole

Dosering:

5 mg/tablet

Lægemiddelform:

Film-coated tablet

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cats

Terapeutisk område:

thiamazole

Terapeutiske indikationer:

Miscellaneous

Autorisation status:

Authorised

Autorisation dato:

2013-09-13

Produktets egenskaber

Health Products Regulatory Authority
18 April 2019
CRN000YRM
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Thiafeline 5 mg Film-coated Tablets for Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
​
ACTIVE SUBSTANCE:
​
​
​
Thiamazole
​5
​
mg
​
​
​
​
EXCIPIENT(S):
​
​
​
Titanium dioxide (E171)
​0.15
​
mg
​
Sunset Yellow FCF (E110)
​0.09
​
mg
Quinoline Yellow WS (E104)
​0.075
​
mg
​
​
​
​
For a full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Film-coated tablet.
Orange 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 pregnant or lactating females. Refer to section 4.7.
Do not use in cases of hypersensitivity to thiamazole or to any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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.
Haemato