Felimazole 5 mg/ml oral solution for cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Thiamazole

Available from:

Dechra Regulatory B.V.

ATC code:

QH03BB02

INN (International Name):

Thiamazole

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

thiamazole

Authorization date:

2023-10-06

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Felimazole 5 mg/ml Oral Solution for Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml dose contains
ACTIVE SUBSTANCE:
Thiamazole
5 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
Methyl parahydroxybenzoate (E218)
2.00 mg
Propyl parahydroxybenzoate
0.20 mg
Citric acid
--
Glycerol
--
Maltitol, liquid
--
Disodium phosphate dihydrate
--
Sodium dihydrogen phosphate dihydrate
--
Saccharin sodium
--
Honey powder flavour
--
Caramel brown colour
--
Purified water
--
Clear, light yellow to yellowish-brown solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cats
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the stabilisation of hyperthyroidism prior to surgical
thyroidectomy.
For the long-term treatment of feline hyperthyroidism.
3.3
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.
2
Do not use in animals with platelet disorders and coagulopathies
(particularly thrombocytopenia).
Do not use in pregnant or lactating females.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Please refer to section 3.7.
3.4
SPECIAL WARNINGS
In order to enhance stabilisation of the hyperthyroid patient the same
feeding and dosing schedule
should be used daily.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
•
If more than 10 mg per day (2 ml of the veterinary medicinal product)
is required, animals should
be monitored particularly carefully.
•
Use of the veterinary medicinal 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 reduci