PRILIUM 150 MG POWDER FOR ORAL SOLUTION FOR DOGS

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

即購入

ダウンロード 製品の特徴 (SPC)
12-06-2017

有効成分:

IMIDAPRIL

から入手可能:

Vetoquinol UK Limited

ATCコード:

QC09AA

INN(国際名):

IMIDAPRIL

投薬量:

150 Milligram

医薬品形態:

Powder for Oral Solution

処方タイプ:

POM: Prescription Only Medicine as defined in relevant national legislation

治療領域:

ACE inhibitors, plain

適応症:

Cardiovascular

認証ステータス:

Authorised

承認日:

2015-11-06

製品の特徴

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PRILIUM 150 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 4 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
150
mg
Sodium benzoate (E211)
30
mg
Excipient to
0.880 g
SOLUTION AFTER RECONSTITUTION
Imidapril hydrochloride
5.0
mg
Sodium benzoate(E211)
1.0
mg
Excipient to
1
ml
For full list of excipients, see 6.1.
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4.5 SPECIAL PRECAUTIONS FOR USE
i) Special precautions for use in animals
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