THIAFELINE 5 MG FILM-COATED TABLETS FOR CATS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
12-03-2015
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Trimite cerere.
Trimite cerere.
Ingredient activ:
THIAMAZOLE
Disponibil de la:
Le Vet Beheer B.V.
Codul ATC:
QH03BB02
INN (nume internaţional):
THIAMAZOLE
Dozare:
5 Milligram
Forma farmaceutică:
Tablets
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Feline
Zonă Terapeutică:
Thiamazole
Indicații terapeutice:
Miscellaneous
Statutul autorizaţiei:
Authorised
Data de autorizare:
2013-09-13
Caracteristicilor produsului
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 cats with hypersensitivity to thiamazole or the excipient, polyethylene glycol.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
As thiamazole can cause haemoconcentration, cats should always have access to drinking water.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 25/02/2015_
_CRN 7019806_
_page number: 1_
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
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