Thyronorm 5 mg/ml Oral Solution for Cats

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Thiamazole

זמין מ:

Norbrook Laboratories (Ireland) Limited

קוד ATC:

QH03BB02

INN (שם בינלאומי):

Thiamazole

כמות:

5 milligram(s)/millilitre

טופס פרצבטיות:

Oral solution

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

איזור תרפויטי:

thiamazole

מצב אישור:

Authorised

תאריך אישור:

2016-06-10

מאפייני מוצר

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Thyronorm 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.
Any animal that suddenly appears unwell during therapy, particularly
if it is febrile,
should have a