Soloxine 0.5 mg Tablet

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Levothyroxine sodium

Verfügbar ab:

Virbac S.A.

ATC-Code:

QH03AA01

INN (Internationale Bezeichnung):

Levothyroxine sodium

Dosierung:

0.5 mg/tablet

Darreichungsform:

Tablet

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiegruppe:

Dogs

Therapiebereich:

levothyroxine sodium

Anwendungsgebiete:

Hormone

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2007-01-19

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Soloxine 0.5 mg Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Levothyroxine Sodium
0.50 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Small elliptical white tablets.
Scored on the face of each tablet , strength in milligrams to the
right and the word SOLOXINE on the reverse.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the long term treatment of thyroid insufficiency in dogs.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient.
Do not use in animals suffering from thyrotoxicosis or uncorrected
adrenal insufficiency
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_1_
_/_
_0_
_2_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_2_
_9_
_6_
_2_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
Appropriate laboratory tests should be conducted to confirm the
diagnosis and ensure correct dosage.
Caution should be exercised in the treatment of dogs with clinically
significant cardiac disease, hypertension or any
disease rendering the animal susceptible to sharply increased
metabolic rate.
In such cases, consideration should be
given to reducing the starting dose, increasing the dose at intervals
whilst monitoring all clinical sign