Leventa 1 mg/ml oral solution for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levothyroxine sodium

Available from:

Intervet Ireland Limited

ATC code:

QH03AA01

INN (International Name):

Levothyroxine sodium

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

levothyroxine sodium

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2007-06-29

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Leventa 1 mg/ml oral solution for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
Active substance:
Levothyroxine sodium (as multihydrate) 1 milligram
(equivalent to 0.97 milligram levothyroxine)
Excipients:
Ethanol 96 %
0.15 ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear, slight reddish coloured solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of hypothyroidism in dogs.
4.3 CONTRAINDICATIONS
Do not use in dogs with hyperthyroidism or uncorrected adrenal
insufficiency (hypoadrenocorticism).
Do not use in case of hypersensitivity to levothyroxine sodium or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5 SPECIAL PRECAUTIONS FOR USE
I)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The product should be used with caution in dogs with cardiac disease,
diabetes mellitus or treated adrenal
insufficiency (hypoadrenocorticism). For these dogs, gradual
introduction of levothyroxine therapy, starting with
25% of the normal dose and increasing by 25% increments every two
weeks until optimal stabilisation is
achieved is recommended.
The clinical diagnosis of hypothyroidis