LEVENTA 1 MG/ML ORAL SOLUTION FOR DOGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVOTHYROXINE SODIUM (AS MULTIHYDRATE) EQUIVALENT TO 0.97 MILLIGRAM LEVOTHYROXINE

Available from:

Intervet Ireland Limited

ATC code:

QH03AA01

INN (International Name):

LEVOTHYROXINE SODIUM (AS MULTIHYDRATE) EQUIVALENT TO 0.97 MILLIGRAM LEVOTHYROXINE

Dosage:

1 Mg/Ml

Pharmaceutical form:

Oral Solution

Prescription type:

POM

Therapeutic group:

Canine

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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 22/04/2016_
_CRN 7023277_
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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 hypothyroidism should be confirmed by laboratory tests.
II)
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to
the physician. Note: this product contains a high�