Leventa 1 mg/ml oral solution for dogs

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Levothyroxine sodium

Fáanlegur frá:

Intervet Ireland Limited

ATC númer:

QH03AA01

INN (Alþjóðlegt nafn):

Levothyroxine sodium

Skammtar:

1 milligram(s)/millilitre

Lyfjaform:

Oral solution

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Dogs

Lækningarsvæði:

levothyroxine sodium

Ábendingar:

Hormone

Leyfisstaða:

Authorised

Leyfisdagur:

2007-06-29

Vara einkenni

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