Fortekor Plus
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
23-03-2021
Produktets egenskaber
(SPC)
23-03-2021
Offentlige vurderingsrapport
(PAR)
08-10-2015
Aktiv bestanddel:
benazepril hydrochloride, pimobendan
Tilgængelig fra:
Elanco GmbH
ATC-kode:
QC09BX90
INN (International Name):
benazepril, pimobendan
Terapeutisk gruppe:
Dogs
Terapeutisk område:
ACE inhibitors, combinations
Terapeutiske indikationer:
For the treatment of congestive heart failure due to atrioventricular valve insufficiency or dilated cardiomyopathy in dogs.
Produkt oversigt:
Revision: 4
Autorisation status:
Authorised
Autorisation dato:
2015-09-08
Indlægsseddel
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
FORTEKOR PLUS 1.25 MG/2.5 MG TABLETS FOR DOGS
FORTEKOR PLUS 5 MG/10 MG TABLETS FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
Germany
Manufacturer responsible for batch release:
Elanco France S.A.S
26 Rue de la Chapelle
F-68330 Huningue
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FORTEKOR PLUS
1.25 mg/2.5 mg tablets for dogs
FORTEKOR PLUS 5 mg/10 mg tablets for dogs
pimobendan/benazepril hydrochloride
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each tablet contains
ACTIVE SUBSTANCES:
pimobendan
benazepril
hydrochloride
FORTEKOR PLUS 1.25 mg/2.5 mg tablets
1.25 mg
2.5 mg
FORTEKOR PLUS 5 mg/10 mg tablets
5 mg
10 mg
EXCIPIENTS:
iron oxide brown
E172
FORTEKOR PLUS 1.25 mg/2.5 mg tablets
0.5 mg
FORTEKOR PLUS 5 mg/10 mg tablets
2 mg
The tablets are bilayered, oval, white and light brown, and can be
divided into halves along the score
line.
4.
INDICATION(S)
For the treatment of congestive heart failure due to atrioventricular
valve insufficiency or dilated
cardiomyopathy in dogs. FORTEKOR PLUS is a fixed dose combination and
should only be used in
patients whose clinical signs are successfully controlled by
administration of the same doses of the
individual components (pimobendan and benazepril hydrochloride) given
concurrently.
18
5.
CONTRAINDICATIONS
Do not use in cases of cardiac output failure due to aortic or
pulmonary stenosis.
Do not use in cases of hypotension (low blood pressure), hypovolemia
(low blood volume),
hyponatremia (low blood sodium levels) or acute renal (kidney)
failure.
Do not use in pregnant or lactating dogs (see section “SPECIAL
WARNINGS").
Do not use in cases of hypersensitivity to pimobendan, to benazepril
hydrochloride or to any ingredient
of the tablets.
6.
ADVERSE REACTIONS
Pimobendan:
A moderate positive chronotropic effect and vomit
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FORTEKOR PLUS
1.25 mg/2.5 mg tablets for dogs
FORTEKOR PLUS 5 mg/10 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
pimobendan
benazepril
hydrochloride
FORTEKOR PLUS 1.25 mg/2.5 mg tablets
1.25 mg
2.5 mg
FORTEKOR PLUS 5 mg/10 mg tablets
5 mg
10 mg
EXCIPIENTS:
iron oxide brown
(E172)
FORTEKOR PLUS 1.25 mg/2.5 mg tablets
0.5 mg
FORTEKOR PLUS 5 mg/10 mg tablets
2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
White and light brown oval bilayer tablets with a score line on both
sides.
The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of congestive heart failure due to atrioventricular
valve insufficiency or dilated
cardiomyopathy in dogs. FORTEKOR PLUS is a fixed dose combination and
should only be used in
patients whose clinical signs are successfully controlled by
administration of the same doses of the
individual components (pimobendan and benazepril hydrochloride) given
concurrently.
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 or pulmonary stenosis).
Do not use in cases of hypotension, hypovolaemia, hyponatremia or
acute renal failure.
Do not use during pregnancy and lactation (see section 4.7).
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In cases of chronic kidney disease, it is recommended to check the
dog’s hydration status before starting
therapy, and to monitor its plasma creatinine and blood erythrocyte
counts during therapy.
As pimobendan is metabolised in the liver, the product
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