Felimazole 5 mg/ml Oral Solution for Cats

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Thiamazole

Tilgjengelig fra:

Dechra Limited

ATC-kode:

QH03BB02

INN (International Name):

Thiamazole

Legemiddelform:

Oral solution

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cats

Terapeutisk område:

Anti Hormone Agent

Autorisasjon status:

Authorized

Autorisasjon dato:

2023-10-03

Preparatomtale

Issued: October 2023
AN: 02116/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Issued: October 2023
AN: 02116/2022
Page 2 of 8
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.
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 dysfu