Felidale 5 mg coated tablets for cats
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
09-05-2024
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Active ingredient:
thiamazole
Available from:
Dechra Ltd
ATC code:
QH03BB02
Dosage:
5 Milligram
Pharmaceutical form:
Coated Tablets
Therapeutic group:
Feline
Therapeutic area:
Miscellaneous
Authorization status:
Authorised
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Felidale 5 mg Coated Tablets for Cats.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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).
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
As thiamazole can cause haemoconcentration, cats should always have access to drinking water.
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 excipients, see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/10/2012_
_CRN 7013521_
_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 : benefit assessment by the clinician.
Du
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