Normazole 5 mg/ml Oral Solution for Cats

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Thiamazole

Disponibbli minn:

Norbrook Laboratories (Ireland) Limited

Kodiċi ATC:

QH03BB02

INN (Isem Internazzjonali):

Thiamazole

Dożaġġ:

5 milligram(s)/millilitre

Għamla farmaċewtika:

Oral solution

Tip ta 'preskrizzjoni:

POM: Prescription Only Medicine as defined in relevant national legislation

Żona terapewtika:

thiamazole

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2018-11-30

Karatteristiċi tal-prodott

Health Products Regulatory Authority
14 May 2021
CRN009Z2C
Page 1 of 5
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.
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 treatment and closely
afterwards.