Thyforon Flavoured 800 Microgram Tablets for Dogs

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

L Thyroxine Sodium

Beschikbaar vanaf:

Eurovet Animal Health B.V.

ATC-code:

QH03A

INN (Algemene Internationale Benaming):

L Thyroxine Sodium

farmaceutische vorm:

Tablet

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Dogs

Therapeutisch gebied:

Hormone

Autorisatie-status:

Authorized

Autorisatie datum:

2011-11-23

Productkenmerken

Revised: December 2020
AN: 00311/2020
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Thyforon flavoured 800 microgram tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE :
800 microgram levothyroxine sodium per tablet equivalent to 778
microgram
levothyroxine
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
Off white round tablet with brown spots, quadrisect with side scores.
The tablets may be divided into halves or quarters.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of hypothyroidism in dogs.
4.3
CONTRA-INDICATIONS
Do not use in dogs suffering from uncorrected adrenal insufficiency.
Do not use in cases of known hypersensitivity to levothyroxine sodium
or to any of
the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The diagnosis of hypothyroidism should be confirmed with appropriate
tests.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The tablets are flavoured. In order to avoid any accidental ingestion,
store tablets out
of reach of animals. A sudden increase in demand for oxygen delivery
to peripheral
tissues, plus the chronotropic effects of levothyroxine sodium, may
place undue
Revised: December 2020
AN: 00311/2020
Page 2 of 6
stress on a poorly functioning heart, causing decompensation and signs
of
congestive heart failure. Hypothyroid dogs suffering from
hypoadrenocorticism have
a decreased ability to metabolise levothyroxine sodium and therefore
an increased
risk of thyrotoxicosis. Dogs with concurrent hypoadrenocorticism and
hypothyroidism
should be stabilised with glucocorticoid and mineralocorticoid
treatment prior to
treatment with levothyroxine sodium to avoid precipitating a
hypoadrenocortical
crisis. After this, thyroid tests should be repeated, then gradual
introduction of
levothyroxine therapy, starting with 25% of the normal dose,
increasing by 25%
increments eve