Thyrasol 5 mg/ml, Oral Solution for Cats

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Thiamazole

Fáanlegur frá:

CP Pharma Handelsgesellschaft mbH

ATC númer:

QH03BB02

INN (Alþjóðlegt nafn):

Thiamazole

Lyfjaform:

Oral solution

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cats

Lækningarsvæði:

Anti Hormone Agent

Leyfisstaða:

Authorized

Leyfisdagur:

2022-12-19

Vara einkenni

Issued: December 2022
AN: 01463/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Thyrasol 5 mg/ml, Oral solution for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Thiamazole
5.0 mg
EXCIPIENTS:
Sodium benzoate (E211)
1.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Solution.
Colourless to slightly brownish, turbid, viscous 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 cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use during pregnancy or lactation. Please refer to section 4.7.
Issued: December 2022
AN: 01463/2021
Page 2 of 6
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.
As thiamazole can cause haemoconcentration, cats should always have
access to
drinking water.
Use of the product in cats with renal dysfunction should be subject to
careful
benefit/risk 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 o