Thyrasol 5 mg/ml, Oral solution for cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Thiamazole

Available from:

CP-Pharma Handelsgesellschaft mbH

ATC code:

QH03BB02

INN (International Name):

Thiamazole

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

thiamazole

Authorization date:

2022-12-23

Summary of Product characteristics

_[Version 8.2,01/2021] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Thyrasol 5 mg/ml, Oral solution for cats (NL, AT, BE, DE, ES, FR, HU,
IE, IT, PL, PT, UK(NI) )
Felithyrol Vet 5 mg/ml, Oral solution for cats (SE/ DK/ FI)
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.
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
dete