Leventa

Country: New Zealand

Language: English

Source: Ministry for Primary Industries

Active ingredient:

levothyroxine sodium pentahydrate

Available from:

Schering-Plough Animal Health Limited

INN (International Name):

levothyroxine sodium pentahydrate

Composition:

levothyroxine sodium pentahydrate 1 g/litre

Therapeutic area:

Endocrine agent (hormone)

Authorization status:

ACVM Registered

Authorization date:

2010-11-12

Summary of Product characteristics

LEVENTA
30 mL – Leaflet, Carton and Label
A010426
Page 1 of 6
LEVENTA
17-May-23
Leaflet
RESTRICTED VETERINARY MEDICINE
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
LEVENTA
®
LEVOTHYROXINE SODIUM 1 MG/ML ORAL SOLUTION FOR DOGS.
COMPOSITION
LEVENTA is an oral solution containing 1 mg/mL levothyroxine sodium
(as multihydrate)
(equivalent to 0.97 mg levothyroxine) and 15% v/v ethanol as
preservative.
INDICATIONS
Treatment of hypothyroidism in dogs.
DIRECTIONS FOR USE
For oral use. Once opened, use within 6 months.
DOSAGE AND ADMINISTRATION
The clinical diagnosis of hypothyroidism should be confirmed by
laboratory tests. In thyroid
hormone replacement therapy with levothyroxine, the dose rate and
regimen have to be tailored
individually to each dog. A starting dose rate of 20 μg levothyroxine
sodium/kg (0.2 mL per 10 kg
body weight) once daily is recommended. Four weeks later, dose
adjustment should be
performed based on the clinical response to treatment and thyroid
hormone concentration
evaluation 4-6 hours after administration of the product. Further
assessment of hormone
responses and dose adjustment may be repeated at 4 week intervals if
required.
A maintenance dose rate between 10 and 40 μg/kg body weight (0.1 –
0.4 mL/10 kg body weight)
once-daily is generally sufficient. The dosage suitable to treat your
dog is decided by your
prescribing veterinarian. Depending on the dosage and the body weight
of the dog, the volume
(in mL) of the product to be administered once-daily can be calculated
using the following table.
BODY WEIGHT
(KG)
DOSAGE (UG/KG)
10
20
30
40
VOLUME OF THE PRODUCT (ML)
5
0.05
0.10
0.15
0.20
10
0.10
0.20
0.30
0.40
15
0.15
0.30
0.45
0.60
20
0.20
0.40
0.60
0.80
25
0.25
0.50
0.75
1.00
30
0.30
0.60
0.90
1.20
35
0.35
0.70
1.05
1.40
40
0.40
0.80
1.20
1.60
45
0.45
0.90
1.35
1.80
50
0.50
1.00
1.50
2.00
The dose for dogs weighing more than 50 kg should be calculated
according to body weight in the
same way.
Once a suitable dose rate and regimen have been established, it is
recommended to