PRILIUM 300 MG POWDER FOR ORAL SOLUTION FOR DOGS

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

IMIDAPRIL

Beszerezhető a:

Vetoquinol UK Limited

ATC-kód:

QC09AA

INN (nemzetközi neve):

IMIDAPRIL

Adagolás:

300 Milligram

Gyógyszerészeti forma:

Powder for Oral Solution

Recept típusa:

POM: Prescription Only Medicine as defined in relevant national legislation

Terápiás terület:

ACE inhibitors, plain

Terápiás javallatok:

Cardiovascular

Engedélyezési státusz:

Authorised

Engedély dátuma:

2015-11-06

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PRILIUM 300 mg powder for oral solution for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Powder for oral solution
Vial containing a white powder. After reconstitution, the solution is
limpid and colourless.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs weighing over 8 kg
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs: treatment of moderate to severe heart failure caused by
mitral regurgitation or by dilated cardiomyopathy.
4.3 CONTRAINDICATIONS
Do not use in dogs with low blood pressure.
Do not use in dogs with acute renal insufficiency.
Do not use in dogs with congenital heart disease.
Do not use in dogs hypersensitive to an ACE inhibitor.
Do not use in dogs with hemodynamically relevant stenoses(aortic
stenosis, mitral valve stenosis, pulmonal stenosis).
Do not use in dogs with obstructive hypertrophic cardiomyopathy.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
POWDER/VIAL
Imidapril hydrochloride
300
mg
Sodium benzoate(E211)
30
mg
Excipient to
1.030 g
SOLUTION AFTER RECONSTITUTION
Imidapril hydrochloride
10.0
mg
Sodium benzoate(E211)
1.0
mg
Excipient to
1
ml
For full list of excipients, see 6.1.
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_
_6_
_/_
_1_
_1_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_1_
_7_
_2_
_0_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
i) Special precautions for use in animals:
Th