natgillin/translations-raw huggingface dataset:
Analysis of heart rate reduction with doses up to 20 mg twice daily indicates a trend towards a plateau effect which is consistent with a reduced risk of severe bradycardia below 40 bpm (see section 4.8).
Analiza znižanja srčne frekvence ob odmerkih do 20 mg dvakrat na dan kaže na težnjo, da učinek doseže plato, kar je skladno z zmanjšanim tveganjem hude bradikardije pod 40 utripov na minuto
PK/PD relationship analysis has shown that heart rate decreases almost linearly with increasing ivabradine and S 18982 plasma concentrations for doses of up to 15-20 mg twice daily.
Analiza razmerja med farmakokinetiko in farmakodinamiko je pokazala, da se srčna frekvenca znižuje skoraj linearno s povečevanjem koncentracije ivabradina in S 18982 v plazmi ob odmerkih do 15 do 20 mg dvakrat na dan.
CYP3A4 inhibitors and inducers are liable to interact with ivabradine and influence its metabolism and pharmacokinetics to a clinically significant extent.
Zaviralci in spodbujevalci citokroma P450 3A4 lahko medsebojno delujejo z ivabradinom ter klinično signifikantno vplivajo na njegovo presnovo in farmakokinetiko.
The main efficacy criterion was the composite of cardiovascular death or non-fatal MI.
Poglavitno merilo učinkovitosti je bil sestavljen izid srčno žilne umrljivosti ali neusodnega miokardnega infarkta.
How to take Corlentor
Kako jemati zdravilo Corlentor
It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers.
ki ne prenašajo ali ne morejo jemati zdravil za srce, imenovanih antagonisti receptorjev beta.
As ivabradine may cause bradycardia, the resulting combination of hypokalemia and bradycardia is a predisposing factor to the onset of severe arrhythmias, especially in patients with long QT syndrome, whether congenital or substance-induced.
Ivabradin lahko povzroči bradikardijo, posledična kombinacija hipokaliemije in bradikardije pa je dejavnik tveganja za nastop hudih aritmij, še posebno pri bolnikih, ki imajo prirojeni sindrom podaljšanega intervala QT ali jemljejo zdravila, ki ga podaljšujejo.
In pivotal phase III clinical trials the following medicinal products were routinely combined with ivabradine with no evidence of safety concerns: angiotensin converting enzyme inhibitors, angiotensin II antagonists, beta-blockers, diuretics, anti-aldosterone agents, short and long acting nitrates, HMG CoA reductase inhibitors, fibrates, proton pump inhibitors, oral antidiabetics, aspirin and other antiplatelet medicinal products.
V ključnih kliničnih študijah III. faze so naslednja zdravila rutinsko kombinirali z ivabradinom, ne da bi opažali težave z varnostjo: zaviralci angiotenzinske konvertaze, antagonisti angiotenzina II, antagonisti adrenergičnih receptorjev beta, diuretiki, antagonisti aldosterona, kratko in dolgodelujoči nitrati, zaviralci hidroksimetilglutaril koencim A (HMG CoA) reduktaze, fibrati, zaviralci protonske črpalke, peroralni antidiabetiki, aspirin ter druga antitrombocitna zdravila.
It is used in combination with standard therapy, including beta-blocker therapy or when betablockers are contraindicated or not tolerated.
Uporablja se v kombinaciji z običajnim zdravljenjem, vključno z zdravljenjem z antagonisti receptorjev beta oziroma ko je zdravljenje z antagonisti receptorjev beta kontraindicirano ali ga bolnik ne prenaša dobro.
Do not take Corlentor if you are breast-feeding (see “Do not take Corlentor”).
Ne jemljite zdravila Corlentor, če dojite (glejte “Ne jemljite zdravila Corlentor”).
Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm.
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.
In patients aged 75 years or more, a lower starting dose should be considered (2.5 mg twice daily i.e. one half 5 mg tablet twice daily) before up-titration if necessary.
Pri bolnikih, starih 75 ali več let, morate razmisliti o manjšem začetnem odmerku (2,5 mg dvakrat na dan, to je eno polovico 5-mg tablete dvakrat na dan), ki ga lahko nato povečate, če je potrebno.
Corlentor with food and drink Avoid grapefruit juice during treatment with Corlentor.
Med zdravljenjem z zdravilom Corlentor se izogibajte uživanju grenivkinega soka.
Rare: Urticaria, itching, skin reddening, feeling unwell.
Koprivnica, srbenje, rdečica kože, občutek slabosti.
Therefore, ivabradine is contra-indicated during breast-feeding (see section 4.3).
Ivabradin je torej kontraindiciran med dojenjem (glejte poglavje 4.3).
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema občasni eozinofilija
The concomitant use of ivabradine with these medicinal products is contraindicated (see section 4.3).
Sočasno jemanje ivabradina s tovrstnimi zdravili je kontraindicirano (glejte poglavje 4.3).
Ivabradine is a pure heart rate lowering agent, acting by selective and specific inhibition of the cardiac pacemaker If current that controls the spontaneous diastolic depolarisation in the sinus node and regulates heart rate.
Ivabradin je specifično zdravilo za zniževanje srčne frekvence, ki deluje s selektivnim in specifičnim zaviranjem frekvenčno urejevalnega toka If v srcu, ki ureja spontano diastolično depolarizacijo v sinusnem vozlu in srčno frekvenco.
The combination of ivabradine 10 mg twice daily with St John's Wort was shown to reduce ivabradine AUC by half.
Opazili so, da kombinacija ivabradina 10 mg dvakrat na dan s šentjanževko zmanjšuje njegovo površino pod krivuljo (AUC) za polovico.
A small statistically significant increase in the PCE was observed in a pre-specified subgroup of patients with angina patients in CCS class II or higher at baseline (n=12049) (annual rates 3.4% versus 2.9%, relative risk ivabradine/placebo 1.18, p=0.018), but not in the subgroup of the overall angina population in CCS class ≥ I (n=14286) (relative risk ivabradine/placebo 1.11, p=0.110).
ali višjega razreda v izhodišču glede na oceno kanadskega srčno-žilnega združenja (CCS) (n = 12.049) (letna stopnja 3,4 % v primerjavi z 2,9%, relativno tveganje ivabradin : placebo 1,18, p = 0,018), vendar ne v podskupini skupne populacije bolnikov z angino pektoris iz razreda ≥ I (n = 14.286) (relativno tveganje ivabradin : placebo 1,11, p = 0,110) glede na oceno CCS.
In a post-hoc subgroup of patients with symptomatic angina at randomisation (n=1507), no safety signal was identified regarding cardiovascular death, hospitalization for acute MI or heart failure (ivabradine 12.0% versus placebo 15.5%, p=0.05).
(n = 1507), niso zaznali signala o varnosti glede srčno-žilne umrljivosti in hospitalizacije zaradi akutnega miokardnega infarkta ali srčnega popuščanja (ivabradin 12,0 %, placebo 15,5 %, p = 0,05).
For the different doses, film-coated tablets containing 5 mg and 7.5 mg ivabradine are available.
Za različna odmerjanja so na voljo filmsko obložene tablete, ki vsebujejo 5 mg in 7,5 mg ivabradina.
Ivabradine influences on retinal function (see section 5.1).
Funkcija vida Ivabradin vpliva na delovanje mrežnice (glejte poglavje 5.1).
In the SIGNIFY study atrial fibrillation was observed in 5.3% of patients taking ivabradine compared to 3.8% in the placebo group.
V študiji SIGNIFY so opažali atrijsko fibrilacijo pri 5,3 % bolnikov, ki so jemali ivabradin, v primerjavi s
In the event of bradycardia with poor haemodynamic tolerance, symptomatic treatment including intravenous betastimulating medicinal products such as isoprenaline may be considered.
Če imajo bolniki bradikardijo s slabim hemodinamičnim prenašanjem, razmislite o simptomatskem zdravljenju, vključno z intravenskimi spodbujevalci receptorjev beta, kot je izoprenalin.
The study showed no difference in the rate of the primary composite endpoint (PCE) in the ivabradine group by comparison to the placebo group (relative risk ivabradine/placebo 1.08, p=0.197).
Študija ni pokazala razlik v stopnji primarnega sestavljenega končnega izida med skupino, ki je jemala ivabradin, in skupino, ki je jemala placebo (relativno tveganje ivabradin : placebo 1,08; p = 0,197).
Luminous phenomena (phosphenes)
Očesne bolezni zelo pogosti pojavi svetlikanja (fosfeni)
- CYP3A4 inducers: CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin, Hypericum perforatum [St John's Wort]) may decrease ivabradine exposure and activity.
- Spodbujevalci citokroma P450 3A4: spodbujevalci citokroma P450 3A4 (na primer rifampicin, barbiturati, fenitoin, Hypericum perforatum [šentjanževka]) lahko zmanjšujejo izpostavljenost ivabradinu in njegovo aktivnost.
Very rare
Zelo redki:
Treatment of chronic heart failure
Zdravljenje kroničnega srčnega popuščanja
Measurement of heart rate
Merjenje srčne frekvence
Irregular rapid contraction of the heart, abnormal perception of heartbeat, uncontrolled blood pressure, headache, dizziness and blurred vision (cloudy vision).
Neredne, hitre kontrakcije srčne mišice, nenormalno zaznavanje srčnega utripa, nenadzorovan krvni tlak,
The SHIFT study was a large multicentre, international, randomised double-blind placebo controlled outcome trial conducted in 6505 adult patients with stable chronic CHF (for ≥ 4 weeks), NYHA class II to IV, with a reduced left ventricular ejection fraction (LVEF ≤ 35%) and a resting heart rate ≥ 70 bpm.
Študija SHIFT je bila obsežno multicentrično, mednarodno, randomizirano, dvojno slepo, s placebo nadzorovano preskušanje izida, ki je zajelo 6505 odraslih bolnikov s stabilnim kroničnim srčnim popuščanjem (≥ 4 tedne) II.
United Kingdom Servier Laboratories Ltd Tel: +44 (0)1 753 666409
Servier Laboratories Ltd Tel: +44 (0)1 753 666409
Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.
Bolnike s kroničnim srčnim popuščanjem z motnjami intraventrikularne prevodnosti (levokračni blok, desnokračni blok) in prekatno dissinhronijo je potrebno pozorno spremljati.
As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your doctor before stopping this medicinal product.
Če ste prenehali jemati zdravilo Corlentor Ker je zdravljenje angine pektoris ali kroničnega srčnega popuščanja običajno doživljenjsko, se pred prenehanjem jemanja tega zdravila posvetujte z zdravnikom.
The intake of St John's Wort should be restricted during the treatment with ivabradine.
Uživanje šentjanževke morate med zdravljenjem z ivabradinom omejiti.
A large dose of Corlentor could make you feel breathless or tired because your heart slows down too much.
Če ste vzeli večji odmerek zdravila Corlentor, kot bi smeli Velik odmerek zdravila Corlentor bi lahko povzročil zasoplost ali utrujenost, ker preveč upočasni srce.
The results on the primary endpoint are mainly driven by the heart failure endpoints, hospitalisation for worsening heart failure (absolute risk reduced by 4.7 %) and deaths from heart failure (absolute risk reduced by 1.1 %).
(absolutno zmanjšanje tveganja za 4,7 %) in umrljivosti zaradi srčnega popuščanja (absolutno zmanjšanje tveganja za 1,1 %).
No safety issue has been raised on the combination of ivabradine with nitrates and dihydropyridine calcium channel blockers such as amlodipine.
Pri kombinaciji ivabradina z nitrati in dihidropiridinskimi kalcijevimi antagonisti, kot je amlodipin, niso opažali težav z varnostjo.
Tablets must be taken orally twice daily, i.e. once in the morning and once in the evening during meals (see section 5.2).
Način uporabe Tablete morajo bolniki jemati peroralno dvakrat na dan, to je eno zjutraj in eno zvečer med obrokom
The concomitant use of potent CYP3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone is contra-indicated (see section 4.3).
Sočasno jemanje močnih zaviralcev citokroma P450 3A4, kot so azolski antimikotiki (ketokonazol, itrakonazol), makrolidnimi antibiotiki (klaritromicin, eritromicin peroralno, josamicin, telitromicin), zaviralci proteaze virusa HIV (nelfinavir, ritonavir) in nefazodon, je kontraindicirano (glejte poglavje 4.3).
Use in patients with AV-block of 2nd degree Ivabradine is not recommended in patients with AV-block of 2nd degree.
Ivabradin ni priporočljiv pri bolnikih z atrioventrikularnim blokom 2. stopnje.
Specific drug-drug interaction studies have shown no clinically significant effect of the following medicinal products on pharmacokinetics and pharmacodynamics of ivabradine: proton pump inhibitors (omeprazole, lansoprazole), sildenafil, HMG CoA reductase inhibitors (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin and warfarin.
Drugo sočasno jemanje Specifične študije o medsebojnih delovanjih z zdravili niso pokazale klinično signifikantnega učinka naslednjih zdravil na farmakokinetiko in farmakodinamiko ivabradina: zaviralcev protonske črpalke (omeprazola, lansoprazola), sildenafila, zaviralcev hidroksimetilglutaril koencim A (HMG CoA) reduktaze (simvastatina), dihidropiridinskih kalcijevih antagonistov (amlodipina, lacidipina), digoksina in varfarina.
Ivabradine is the S-enantiomer with no bioconversion demonstrated in vivo.
S-enantiomer in ni dokazov za njegovo biološko konverzijo in vivo.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni mišični krči
Concomitant use of ivabradine with heart rate reducing calcium channel blockers such as verapamil or diltiazem is contraindicated (see sections 4.3 and 4.5).
Kombinacija z zaviralci kalcijevih kanalčkov Sočasno jemanje ivabradina s kalcijevimi antagonisti, ki znižujejo srčno frekvenco, kot sta verapamil in diltiazem, je kontraindicirano (glejte poglavji 4.3 in 4.5).
Excipient with known effect: 61.215 mg lactose monohydrate For the full list of excipients, see section 6.1.
Pomožna snov z znanim učinkom: 61,215 mg laktoze monohidrata.
The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do
Diplopia Visual impairment
diplopija okvara vida
Skin and subcutaneous tissue Uncommon*
Bolezni kože in podkožja občasni*
The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.
Najpogostejši simptomi srčnega popuščanja vključujejo zasoplost, slabotnost,
A large outcome study, SIGNIFY, was performed in 19102 patients with coronary artery disease and without clinical heart failure (LVEF > 40%), on top of optimal background therapy.
Obsežna študija o izidih SIGNIFY je zajela 19.102 bolnikov s koronarno arterijsko boleznijo in brez kliničnega srčnega popuščanja (iztisni delež levega prekata > 40 %), ki so že prejemali optimalno osnovno zdravljenje.
It is recommended to regularly clinically monitor ivabradine treated patients for the occurrence of atrial fibrillation (sustained or paroxysmal), which should also include ECG monitoring if clinically indicated (e.g. in case of exacerbated angina, palpitations, irregular pulse).
Atrijska fibrilacija je bolj pogosta pri bolnikih, ki sočasno jemljejo amiodaron in močne antiaritmike skupine I. Pri bolnikih, ki jemljejo ivabradin, je priporočljivo redno klinično spremljanje možnosti pojava atrijske fibrilacije (vztrajne ali paroksizmalne), kar mora vključevati tudi elektrokardiogram, če je klinično indiciran (na primer pri bolnikih s poslabšanjem angine pektoris, palpitacijami, nerednim utripom).
Do not take Corlentor if you are pregnant or are planning to have a baby (see “Do not take Corlentor”).
Nosečnost in dojenje Ne jemljite zdravila Corlentor, če ste noseči ali če načrtujete nosečnost (glejte “Ne jemljite zdravila
ECG prolonged QT interval * Frequency calculated from clinical trials for adverse events detected from spontaneous report
*Pogostnost neželenih učinkov iz spontanega poročanja je izračunana na podlagi podatkov iz kliničnih študij Opis izbranih neželenih učinkov
Cardiac arrhythmias
Možganska kap
de los Madroños, 33 -28043 Madrid, Spain The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
Syncope, possibly related to bradycardia
sinkopa, možno zaradi bradikardije
After three to four weeks of treatment, if the patient is still symptomatic, if the initial dose is well tolerated and if resting heart rate remains above 60 bpm, the dose may be increased to the next higher dose in patients receiving 2.5 mg twice daily or 5 mg twice daily.
Po treh do štirih tednih zdravljenja, če bolnik še vedno doživlja simptome, vendar dobro prenaša začetni odmerek, in če srčna frekvenca v mirovanju ostaja pod 60 utripov na minuto, lahko odmerek povečate na naslednji večji odmerek pri bolnikih, ki se zdravijo z 2,5 mg odmerkom dvakrat na dan oz. 5 mg odmerkom dvakrat na dan. Vzdrževalni odmerek ne sme presegati 7,5 mg dvakrat na dan.
Excipient with known effect: 63.91 mg lactose monohydrate For the full list of excipients, see section 6.1.
Pomožna snov z znanim učinkom: 63,91 mg laktoze monohidrata.
Uncontrolled blood pressure
Žilne bolezni pogosti nenadzorovan krvni tlak občasni*
Cessation of treatment should be considered if any unexpected deterioration in visual function occurs.
Če se pojavi kakršnokoli nepričakovano poslabšanje funkcije vida, razmislite o prekinitvi zdravljenja.
- if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heart beat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
- če imate kardiogeni šok (bolezen srca, ki zahteva zdravljenje v bolnišnici); - če imate motnje srčnega ritma; - če imate miokardni infarkt; - če imate zelo nizek krvni tlak; - če imate nestabilno angino pektoris (hudo obliko, pri kateri se bolečine v prsih pojavljajo zelo pogosto, med naporom ali brez njega);
Corlentor 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other.
Tablete zdravila Corlentor 7,5 mg so lososove barve, trikotne in filmsko obložene, z zarezo na obeh straneh in vrezano oznako “7.5” na eni ter na drugi strani.
The European Medicines Agency has waived the obligation to submit the results of studies with Corlentor in all subsets of the paediatric population in the treatment of angina pectoris.
Corlentor za vse podskupine pediatrične populacije za zdravljenje angine pektoris.
No dose adjustment is required in patients with mild hepatic impairment.
Pri bolnikih z blago jetrno okvaro odmerka ni treba prilagajati.
NAME OF THE MEDICINAL PRODUCT Corlentor 7.5 mg film-coated tablets
IME ZDRAVILA Corlentor 7,5 mg filmsko obložene tablete
Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Corlentor.
Če dojite ali nameravate dojiti se posvetujte z zdravnikom, ker morate z dojenjem prekiniti, če jemljete zdravilo Corlentor.
What Corlentor contains - The active substance is ivabradine (as hydrochloride).
- Zdravilna učinkovina je ivabradin (v obliki klorida).
Data are insufficient to draw conclusions in patients with moderate hepatic impairment.
O bolnikih z zmernim jetrnim popuščanjem ni dovolj podatkov za postavljanje zaključkov.
NAME OF THE MEDICINAL PRODUCT Corlentor 5 mg film-coated tablets
IME ZDRAVILA Corlentor 5 mg filmsko obložene tablete
In a pooled analysis of all the Phase II/III double blind controlled clinical trials with a duration of at least 3 months including more than 40,000 patients, the incidence of atrial fibrillation was 4.86% in ivabradine treated patients compared to 4.08% in controls, corresponding to a hazard ratio of 1.26, 95% CI [1.15-1.39].
bolnikov, je bila pojavnost atrijske fibrilacije 4,86% pri bolnikih, ki so jemali ivabradin v primerjavi s 4,08% pojavnostjo v kontrolni skupini, kar ustreza razmerju tveganja 1,26, 95% IZ [1,15-1,39].
QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol,
Zdravila, ki podaljšujejo interval QT: - srčno-žilna zdravila, ki podaljšujejo interval QT (na primer kinidin, dizopiramid, bepridil, sotalol,
Treatment effect on the primary composite endpoint, its components and secondary endpoints
Primarni sestavljeni končni izid Komponente sestavljenega končnega izida:
The concomitant use of cardiovascular and non cardiovascular QT prolonging medicinal products with ivabradine should be avoided since QT prolongation may be exacerbated by heart rate reduction.
halofantrin, pentamidin, cisaprid, eritromicin intravensko) Sočasni uporabi srčno-žilnih in nesrčno-žilnih zdravil, ki podaljšujejo interval QT, se morate ob ivabradinu izogibati, saj se podaljšanje intervala QT lahko poslabša z zniževanjem srčne frekvence.
If during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia, the dose must be titrated downward to the next lower dose in patients receiving 7.5 mg twice daily or 5 mg twice daily.
Če se med zdravljenjem srčna frekvenca vztrajno znižuje pod 50 utripov na minuto med mirovanjem ali če bolniki doživljajo simptome, povezane z bradikardijo, morate odmerek titrirati navzdol do naslednjega manjšega odmerka pri bolnikih, ki jemljejo 7,5 mg dvakrat dnevno ali 5 mg dvakrat dnevno.
No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 ml/min (see section 5.2).
Pri bolnikih z ledvično okvaro in očistkom kreatinina nad 15 ml/min odmerka ni potrebno prilagajati
In the subgroup of patients with HR ≥ 75 bpm and on the recommended target dose of beta-blocker, no statistically significant benefit was observed on the primary composite endpoint (hazard ratio: 0.97, 95%CI [0.74;1.28]) and other secondary endpoints, including hospitalisation for worsening heart failure (hazard ratio: 0.79, 95% CI [0.56;1.10]) or death from heart failure (hazard ratio: 0.69, 95% CI [0.31;1.53]).
V podskupini bolnikov s srčno frekvenco ≥ 75 utripov na minuto zdravljenih s priporočenim ciljnim odmerkom antagonista adrenergičnih receptorjev beta, ni bilo opažene statistično značilne koristi glede primarnega sestavljenega končnega izida (razmerje tveganja: 0,97, 95 % interval zaupanja [0,74; 1,28]) in drugih sekundarnih končnih izidov, vključno s hospitalizacijo zaradi poslabšanja srčnega popuščanja
How to store Corlentor
Shranjevanje zdravila Corlentor
If, during treatment, resting heart rate decreases persistently below 50 bpm or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate below 50 bpm or symptoms of bradycardia persist (see section 4.2).
Če se med zdravljenjem srčna frekvenca vztrajno znižuje pod 50 utripov na minuto med mirovanjem ali če imajo bolniki simptome, povezane z bradikardijo, kot so omotica, utrujenost ali hipotenzija, morate odmerek titrirati navzdol ali zdravljenje prekiniti, če srčna frekvenca pod 50 utripov na minuto ali simptomi bradikardije vztrajajo (glejte poglavje 4.2).