Leventa 1 mg/ml Oral Solution for Dogs

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

L Thyroxine Sodium

Saatavilla:

MSD Animal Health UK Limited

ATC-koodi:

QH03AA01

INN (Kansainvälinen yleisnimi):

L Thyroxine Sodium

Lääkemuoto:

Oral solution

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

Hormone

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2007-04-23

Valmisteyhteenveto

Revised: August 2020
AN: 00299/2020
Page 1 of 6
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.
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
Revised: August 2020
AN: 00299/2020
Page 2 of 6
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
concentration of L-thyroxine sodium and may present a risk to humans
if ingested.
Wash hands after use.
In case of eye contact, flush immediately with water.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Adverse reactions associated with treatment with L-thyroxine sodium
are primarily
those of hyperthyroidis