Vidalta 15 mg tablets for Oral Use for Cats
Country: Malta
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
16-03-2013
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Active ingredient:
carbimazole 15 mg
Available from:
Intervet Intenational BV
ATC code:
QH03BB01
Pharmaceutical form:
Tablet
Therapeutic group:
carbimazole
Therapeutic area:
Cats
Authorization date:
2011-10-26
Summary of Product characteristics
Revised: January 2012
AN: 02007/2010
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vidalta 15 mg prolonged-release tablets for cats
BE, NO: Vidalta Vet 15 mg prolonged release tablets for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains:
ACTIVE SUBSTANCE:
Carbimazole
15,00 mg
EXCIPIENTS:
Red ferric oxide (E172)
0.75 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
Round dark pink tablet with little spots
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cat
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of hyperthyroidism and hyperthyroidism-associated clinical signs in cats
4.3
CONTRAINDICATIONS
Do not use in cats suffering from concurrent systemic diseases, such as severe primary
liver disease or diabetes mellitus.
Do not use in cats showing signs of auto-immune diseases and/or altered red or white
blood cell counts, such as anaemia, neutropaenia or lymphopaenia.
Do not use in cats with platelet disorders (particularly thrombocytopaenia) or
coagulopathies.
Revised: January 2012
AN: 02007/2010
Page 2 of 8
Do not use in cats with hypersensitivity to mercaptoimidazoles (carbimazole or
thiamazole (methimazole)) Please refer to section 4.7.
4.4
SPECIAL WARNINGS FOR THE TARGET SPECIES
Thiamazole (methimazole), the active metabolite of carbimazole, inhibits thyroid
hormone production and therefore cessation of treatment with carbimazole will r
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