VETMEDIN 1.25 MG CHEWABLE TABLETS FOR DOGS

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

PIMOBENDAN

제공처:

Boehringer Ingelheim Ltd

ATC 코드:

QC01CE90

INN (International Name):

PIMOBENDAN

복용량:

1.25 mg/tablet

약제 형태:

Tablets Chewable

처방전 유형:

POM

치료 그룹:

Canine

치료 영역:

Pimobendane

치료 징후:

Cardiovascular

승인 상태:

Authorised

승인 날짜:

2012-11-05

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 1.25 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains:
ACTIVE SUBSTANCE:
pimobendan
1.25 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Oblong, scored, mottled brown tablets with fine white spots, embossed with Boehringer Ingelheim logo and P01.
The tablet can be divided into equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency
(mitral and/or tricuspid valve regurgitation).
(See also section 4.9).
For the treatment of dilated cardiomyopathy in the preclinical stage (asymptomatic with an increase in left ventricular
end-systolic and end-diastolic diameter) in Doberman Pinschers following echocardiographic diagnosis of cardiac
disease (see section 4.4 and 4.5).
4.3 CONTRAINDICATIONS
Do not use pimobendan in hypertrophic cardiomyopathies or in diseases in which an improvement in cardiac output
cannot be achieved for functional or anatomical reasons (e.g. aortic stenosis).
Since pimobendan is metabolised mainly via the liver, it should not be used in dogs with severe impairment of liver
function (see also 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product has not been tested in cases of asymptomatic DCM in Dobermans with atrial fibrillation or sustained
ventricular tachycardia.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 27/11/2015_
_CRN 7020972_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions