Kelevo 800 µg tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levothyroxine sodium

Available from:

LIVISTO Int'l, S.L.

ATC code:

QH03AA01

INN (International Name):

Levothyroxine sodium

Dosage:

800 µg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

levothyroxine sodium

Authorization status:

Authorised

Authorization date:

2021-06-11

Summary of Product characteristics

Health Products Regulatory Authority
03 February 2022
CRN00CQF7
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Kelevo 800 µg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
​
ACTIVE SUBSTANCE:
​
​
Levothyroxine sodium
​
800 µg
​
(equivalent to levothyroxine
​
778 μg)
​
​
​
EXCIPIENTS:
​
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off white, round and convex tablet with brown spots and a
cross-shaped break line on one side. The tablets can be
divided into 2 or 4 equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of primary and secondary hypothyroidism.
4.3 CONTRAINDICATIONS
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
A sudden increase in demand for oxygen delivery to peripheral tissues,
plus the chronotropic effects of levothyroxine sodium,
may place undue stress on a poorly functioning heart, causing
decompensation and signs of congestive heart failure.
Hypothyroid animals with concurrent hypoadrenocorticism have a
decreased ability to metabolise levothyroxine sodium and
therefore an increased risk of thyrotoxicosis. These animals 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
is recommended (starting with 25 % of the normal dose
and increasing by 25% increments every fortnight until optimal
stabilisation is achieved). Gradual introduction of therapy is
also recommended for anima