Ivabradine Zentiva

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-07-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-07-2023
Public Assessment Report Public Assessment Report (PAR)
08-02-2017

Active ingredient:

ivabradinijev klorid

Available from:

Zentiva, k.s.

ATC code:

C01EB17

INN (International Name):

ivabradine

Therapeutic group:

Srčna terapija

Therapeutic area:

Angina Pectoris; Heart Failure

Therapeutic indications:

Simptomatsko zdravljenje kronične stabilne angine pektoris Ivabradine je indicirano za simptomatsko zdravljenje kronične stabilne angine pektoris pri koronarne bolezni odraslih s običajen sinusni ritem in srčni utrip ≥ 70 bpm. Ivabradine je navedeno:v odrasli ne morejo prenašati ali kontraindikacij za uporabo beta-blockersorin kombinaciji z beta blokatorji pri bolnikih neustrezno nadzorovano z optimalno beta-blocker odmerek. Zdravljenje kroničnega srčnega popuščanja Ivabradine navedena v kronično srčno popuščanje NYHA II do IV razreda z sistolični disfunkcija, pri bolnikih v sinusni ritem in katerih srčni utrip je ≥ 75 bpm, v kombinaciji s standardno zdravljenje, vključno z zdravljenjem s beta-blocker ali Kdaj je terapija beta-blocker kontraindiciran ali ne prenaša.

Product summary:

Revision: 6

Authorization status:

Pooblaščeni

Authorization date:

2016-11-11

Patient Information leaflet

                                25
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 25 °C. Shranjujte v originalni ovojnini
za zagotovitev zaščite pred vlago.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Češka
12.
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
EU/1/16/1144/001
EU/1/16/1144/002
EU/1/16/1144/003
EU/1/16/1144/004
EU/1/16/1144/005
EU/1/16/1144/006
EU/1/16/1144/007
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Ivabradin Zentiva 5 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
26
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI*
PC
SN
NN
27
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOT
1.
IME ZDRAVILA
Ivabradin Zentiva 5 mg filmsko obložene tablete
ivabradin
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Zentiva logotip
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
DRUGI PODATKI
Pon [sonce]
Pon [luna]
Tor [sonce]
Tor [luna]
Sre [sonce]
Sre [luna]
Čet [sonce]
Čet [luna]
Pet [sonce]
Pet [luna]
So [sonce]
So [luna]
Ne [sonce]
Ne [luna]
28
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
1.
IME ZDRAVILA
Ivabradin Zentiva 7,5 mg filmsko obložene tablete
ivabradin
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (v obliki
klorida).
3.
SEZNAM POMOŽNIH SNOVI
4.
FARMACEVTSKA OBLIKA IN VSEBINA
filmsko obložena tableta
14 filmsko obloženih tablet
28 filmsko obloženih tablet
56 filmsko obloženih tablet
84 filmsko obloženih tablet
98 filmsko obloženih tablet
100 filmsko obloženih tablet
112 filmsko obloženih tablet
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo!
peroralna uporaba
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdra
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Ivabradin Zentiva 5 mg filmsko obložene tablete
Ivabradin Zentiva 7,5 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ivabradin Zentiva 5 mg filmsko obložene tablete
Ena filmsko obložena tableta vsebuje 5 mg ivabradina (v obliki
klorida).
Ivabradin Zentiva 7,5 mg filmsko obložene tablete
Ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (v obliki
klorida).
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta
Ivabradin Zentiva 5 mg filmsko obložene tablete
Okrogle, bikonveksne bele tablete z globoko zarezo na eni strani in
vtisnjeno številko 5 premera 6,5 mm
na drugi strani. Tableta se lahko deli na enake odmerke.
Ivabradin Zentiva 7,5 mg filmsko obložene tablete
Bele do umazano bele, okrogle tablete premera 7,1 mm.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Simptomatsko zdravljenje kronične stabilne angine pektoris
Ivabradin je indiciran za simptomatsko zdravljenje kronične stabilne
angine pektoris pri odraslih s
koronarno arterijsko boleznijo z normalnim sinusnim ritmom in srčno
frekvenco ≥ 70 utripov na minuto.
Ivabradin je indiciran:
‒
pri odraslih, pri katerih so antagonisti adrenergičnih receptorjev
beta kontraindicirani ali jih ne
prenašajo
ali
‒
v kombinaciji z antagonisti adrenergičnih receptorjev beta pri
bolnikih, ki ob optimalnem odmerku
antagonistov adrenergičnih receptorjev beta nimajo urejene bolezni.
Zdravljenje kroničnega srčnega popuščanja
Ivabradin je indiciran za zdravljenje kroničnega srčnega
popuščanja II. do IV. razreda po funkcijski
razvrstitvi Newyorškega društva za srce (NYHA) s sistolično
disfunkcijo pri bolnikih v sinusnem ritmu,
pri katerih je srčna frekvenca ≥ 75 utripov na minuto, v
kombinaciji s standardno terapijo, vključno z
3
zdravljenjem z antagonistom adrenergičnih receptorjev beta oziroma
tudi ko je zdravljenje z antagonistom
adrenergičnih receptorjev beta kontraindicirano ali ga bolnik ne
pren
                                
                                Read the complete document

Similar products

Active ingredient ivabradinijev klorid

ivabradinijev klorid

ATC code C01EB17

C01EB17

Marketed by Zentiva, k.s.

Zentiva, k.s.

INN (International Name) ivabradine

ivabradine

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Summary of Product characteristics Summary of Product characteristics Bulgarian 13-07-2023
Public Assessment Report Public Assessment Report Bulgarian 08-02-2017
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