Cardisure 3.5 mg/ml Oral Solution for Dogs

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Pimobendan

Fáanlegur frá:

Dechra Regulatory B.V.

ATC númer:

QC01CE90

INN (Alþjóðlegt nafn):

Pimobendan

Skammtar:

3.5 milligram(s)/millilitre

Lyfjaform:

Oral solution

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

pimobendan

Leyfisstaða:

Authorised

Leyfisdagur:

2019-09-13

Vara einkenni

Health Products Regulatory Authority
02 February 2022
CRN00CPGY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cardisure 3.5 mg/ml Oral Solution for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Pimobendan
3.5​
​
mg
​
EXCIPIENTS:
​
​
​
Benzyl alcohol (E1519)
1.0​
mg​
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Oral Solution.
Clear, colourless, semi-viscous liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of canine congestive heart failure originating from
valvular insufficiency (mitral and/or tricuspid
regurgitation) or dilated cardiomyopathy.
4.3 CONTRAINDICATIONS
Do not use in cases of hypertrophic cardiomyopathies or clinical
conditions where an augmentation of cardiac output is not
possible for functional or anatomical reasons (e.g. aortic stenosis).
Do not use in dogs with severe impairment of liver function, as
pimobendan is metabolised mainly via the liver.
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The blood glucose should be tested regularly during treatment in dogs
with existing diabetes mellitus.
Monitoring of cardiac function and morphology is recommended in
animals treated with pimobendan (See also section 4.6).
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Accidental ingestion, especially by a child, may lead to the
occurrence of tachycardia, orthostatic hypotension, flushing of the
face and headaches. To avoid accidental ingestion, do not leave the
filled syringe unattended and store the bottle and used
syringe in the original carton in order to prevent children from
getting access to the product. Close bottle tightly wit