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:

2024-02-08

Preparatomtale

Issued: February 2024
AN: 02095/2022
Page 1 of 7
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:
Methyl parahydroxybenzoate
2.00 mg
Propyl parahydroxybenzoate
0.20 mg
3.
PHARMACEUTICAL FORM
Oral Solution
Clear, light yellow to yellowish-brown solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the stabilisation of hyperthyroidism 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.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Please refer to section 4.7.
Issued: February 2024
AN: 02095/2022
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
In order to enhance stabilisation of the hyperthyroid patient the same
feeding
and dosing schedule should be used daily.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
•
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 reducing the glomerular filtration rate,
the effect
of therapy on renal function should be monitored closely as
deterioration of an
underlying condition may occur.
•
Haematology must be monitored due to risk of leucope