Normazole 5 mg/ml Oral Solution for Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Thiamazole

Available from:

Norbrook Laboratories Limited

ATC code:

QH03BB02

INN (International Name):

Thiamazole

Pharmaceutical form:

Oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats

Therapeutic area:

Anti Hormone Agent

Authorization status:

Authorized

Authorization date:

2016-05-19

Summary of Product characteristics

Revised: July 2021
AN: 01048/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Normazole 5 mg/ml Oral Solution for Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Thiamazole
5 mg
EXCIPIENT:
Sodium Benzoate (E211)
1.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
An off-white to light yellow opaque solution
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 pregnant or lactating females. Please refer to section
4.7.
Do not use in known cases of hypersensitivity to the active substance
or to
any of the excipients.
Revised: July 2021
AN: 01048/2020
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 of thiamazole 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. 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
renal
impairment may occur.
Haematology must be monitored due to risk of leucopenia or haemolytic
anaemia before initiating treatmen