Pimobendan Vetmedin 1.25 mg Chewable Tablets for Dogs
Država: Velika Britanija
Jezik: engleski
Izvor: HMA (Heads of Medicines Agencies)
Uputa o lijeku
(PIL)
31-08-2013
Svojstava lijeka
(SPC)
31-08-2013
Aktivni sastojci:
pimobendan 1.25 mg
Dostupno od:
Boehringer Ingelheim Vetmedica GmbH
ATC koda:
QC01CE90
Farmaceutski oblik:
Chewable tablet
Terapijska grupa:
pimobendane
Područje terapije:
Dogs
Datum autorizacije:
2012-01-27
Uputa o lijeku
1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 1.25 mg chewable tablets for dogs
(AT, BG, CY, CZ, EE, EL, HU, LV, LT, PL, RO, SI, SK, ES, IS, LI, PT, BE, LU, NL)
[Pimobendan Vetmedica 1.25 mg chewable tablets for dogs
(FI, FR, IE, IT, SE, UK)
Pimobendan Boehringer Ingelheim Vetmedica GmbH 1.25 mg chewable tablets for dogs
(NO)
The name ‘the product’ will be used in the Product Information]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains:
ACTIVE SUBSTANCE:
Pimobendan
1.25 mg
EXCIPIENTS:
For a 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 halves.
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).
4.3
CONTRAINDICATIONS
[The product] is not to be used 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 [the product] is metabolised mainly via the liver, it should not be used in dogs with severe
impairment of liver function (see also 4.7).
3
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PREC
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Svojstava lijeka
1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 1.25 mg chewable tablets for dogs
(AT, BG, CY, CZ, EE, EL, HU, LV, LT, PL, RO, SI, SK, ES, IS, LI, PT, BE, LU, NL)
[Pimobendan Vetmedica 1.25 mg chewable tablets for dogs
(FI, FR, IE, IT, SE, UK)
Pimobendan Boehringer Ingelheim Vetmedica GmbH 1.25 mg chewable tablets for dogs
(NO)
The name ‘the product’ will be used in the Product Information]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains:
ACTIVE SUBSTANCE:
Pimobendan
1.25 mg
EXCIPIENTS:
For a 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 halves.
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).
4.3
CONTRAINDICATIONS
[The product] is not to be used 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 [the product] is metabolised mainly via the liver, it should not be used in dogs with severe
impairment of liver function (see also 4.7).
3
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PREC
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