natgillin/translations-raw huggingface dataset:
Annopol 6B - 03-236 Warszawa, Poland Laboratorios Servier, S.L, Avda.
Annopol 6B - 03-236 Varšava, Poljska Laboratorios Servier, S.L, Avda. de los Madroños, 33 -28043 Madrid, Španjolska
About chronic heart failure :
O kroničnom zatajenju srca:
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).
U post-hoc analizi podskupine bolesnika sa simptomatskom anginom pri randomizaciji (n=1507), sigurnost bolesnika nije bila ugrožena glede kardiovaskularne smrtnosti, hospitalizacije zbog akutnog infarkta miokarda ili srčanog popuštanja (ivabradin 12,0% u usporedbi s placebom 15,5%, p=0,005).
INFORMATION IN BRAILLE CORLENTOR 5 mg
16. PODACI NA BRAILLEOVOM PISMU CORLENTOR 5 mg
- CYP3A4 inducers: CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin, Hypericum perforatum [St John's Wort]) may decrease ivabradine exposure and activity.
- CYP3A4 induktori: CYP3A4 induktori (npr. rifampicin, barbiturati, fenitoin, Hypericum perforatum [Gospina trava]) mogu smanjiti koncentraciju i djelovanje ivabradina.
In the SHIFT trial more patients experienced episodes of increased blood pressure while treated with ivabradine (7.1%) compared to patients treated with placebo (6.1%).
U ispitivanju SHIFT veći broj bolesnika liječenih ivabradinom doživjelo je epizode povišenog krvnog tlaka (7,1%) u usporedbi sa placebom (6,1%).
Lack of benefit on clinical outcomes in patients with symptomatic chronic stable angina pectoris Ivabradine is indicated only for symptomatic treatment of chronic stable angina pectoris because ivabradine has no benefits on cardiovascular outcomes (e.g. myocardial infarction or cardiovascular death ) (see section 5.1).
Nedostatak koristi kod kliničkih ishoda u bolesnika sa simptomima kronične stabilne angine pektoris Ivabradin je indiciran samo za simptomatsko liječenje kronične stabilne angine pektoris jer nema koristi kod kardiovaskularnih ishoda (npr. infarkt miokarda ili kardiovaskularna smrtnost) (vidjeti dio 5.1).
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.
Ispitivanja specifičnih interakcija između dva lijeka pokazala su da slijedeći lijekovi nemaju klinički značajan učinak na farmakokinetiku i farmakodinamiku ivabradina: blokatori protonske pumpe (omeprazol, lanzoprazol), sildenafil, inhibitori HMG CoA reduktaze (simvastatin), dihidropiridinski blokatori kalcijevih kanala (amlodipin, lacidipin), digoksin i varfarin.
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 lijek za usporavanje srčane frekvencije, koji djeluje selektivnom i specifičnom inhibicijom If struje predvodnika srčanog ritma, koji regulira spontanu dijastoličku depolarizaciju u sinusnom čvoru i regulira frekvenciju srca.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati Uputu o lijeku.
mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
pentamidin, cisaprid, intravenski eritromicin).
Ivabradine is metabolised by CYP3A4 only and it is a very weak inhibitor of this cytochrome.
Ivabradin se metabolizira jedino citokromom CYP3A4 i vrlo je slab inhibitor toga citokroma.
In addition there was no clinically significant effect of ivabradine on the pharmacokinetics of simvastatin, amlodipine, lacidipine, on the pharmacokinetics and pharmacodynamics of digoxin, warfarin and on the pharmacodynamics of aspirin.
Ivabradin nije imao klinički značajan učinak na farmakokinetiku simvastatina, amlodipina, lacidipina, na farmakokinetiku i farmakodinamiku digoksina, varfarina te na farmakodinamiku aspirina.
Do not take Corlentor if you are breast-feeding (see “Do not take Corlentor”).
Ne uzimajte Corlentor ako dojite (vidjeti “Nemojte uzimati Corlentor”).
Moderate CYP3A4 inhibitors: specific interaction studies in healthy volunteers and patients have shown that the combination of ivabradine with the heart rate reducing agents diltiazem or verapamil resulted in an increase in ivabradine exposure (2 to 3 fold increase in AUC) and an additional heart rate reduction of 5 bpm.
Umjereni CYP3A4 inhibitori: ispitivanja specifičnih interakcija na zdravim dobrovoljcima i bolesnicima pokazala su da je kombinacija ivabradina s diltiazemom ili verapamilom (lijekovima koji usporavaju srčanu frekvenciju) uzrokovala povećanje koncentracije ivabradina (dvostruko do trostruko povećanje
The main efficacy criterion was the composite of cardiovascular death or non-fatal MI.
Glavni kriterij djelotvornosti bio je skup kardiovaskularnih smrtnosti ili nefatalni infarkt miokarda.
(see section 5.1)
(vidjeti dio 4.4).
Cardiac arrhythmias
Kardiogeni šok
For the different doses, film-coated tablets containing 5 mg and 7.5 mg ivabradine are available.
Doziranje Za različite doze dostupne su filmom obložene tablete koje sadržavaju 5 mg i 7,5 mg ivabradina.
These data are consistent with the pharmacological effect of ivabradine related to its interaction with hyperpolarisation-activated Ih currents in the retina, which share extensive homology with the cardiac pacemaker If current.
Ti se podaci slažu s farmakološkim učinkom ivabradina, koji se odnosi na njegovu interakciju s Ih strujama aktiviranim hiperpolarizacijom u mrežnici, koje se u velikoj mjeri podudaraju sa If strujom srčanog predvodnika.
The major active metabolite is the N-desmethylated derivative (S 18982) with an exposure about 40% of that of the parent compound.
N-desmetilirani derivat (S 18982) s koncentracijom oko 40% koncentracije roditeljske tvari.
The average plasma concentration is 10 ng/ml (CV=38%) at steady-state.
Prosječna je koncentracija u plazmi u stanju dinamičke ravnoteže 10 ng/ml (CV=38%).
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.
Veliko ispitivanje ishoda, SIGNIFY, provedeno je u 19102 bolesnika s koronarnom arterijskom bolešću bez kliničkih znakova zatajenja srca (LVEF <40%) uz optimalnu osnovnuterapiju.
The combination of ivabradine 10 mg twice daily with St John's Wort was shown to reduce ivabradine AUC by half.
Pokazalo se da se kombinacijom ivabradina u dozi od 10 mg dva puta na dan s Gospinom travom, AUC ivabradina smanjuje za pola.
Rare: Urticaria, itching, skin reddening, feeling unwell.
Urtikarija (koprivnjača), svrbež, crvenilo kože, opće loše osjećanje.
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.
U kliničkim ispitivanjima faze III, slijedeći lijekovi su rutinski primjenjivani s ivabradinom bez štetnih utjecaja: inhibitori konvertaze angiotenzina, antagonisti angiotenzina II, diuretici, nitrati brzog i dugog djelovanja, inhibitori HMG CoA reduktaze, fibrati, blokatori protonske pumpe, oralni antidijabetici, aspirin i antikoagulansi.
A drug utilisation study conducted in several EEA countries aimed at describing the characteristics of ivabradine users, as well as describing the patterns of use of ivabradine, and adherence to the risk minimisation measures.
Ispitivanje praćenja primjene lijeka u nekoliko država EGP-a s ciljem da se opišu osobine bolesnika koji koriste ivabradin, kao i obrasci primjene ivabradina te lipanj 2018.
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.
Potrebno je izbjegavati istodobnu primjenu ivabradina i kardiovaskularnih i ostalih lijekova koji produljuju QT-interval jer se QT-prolongacija može pogoršati uslijed usporenja srčane frekvencije.
A MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co. Wicklow, Ireland Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, Francuska Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co.
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).
Mali, ali statistički značajan porast u PCE zabilježen je u prethodno definiranoj podskupini bolesnika s početno utvrđenom anginom pektoris CCS klase II ili više (n = 12 049) (godišnje stope 3,4% naspram 2,9%, relativni rizik ivabradin/placebo 1,18, p= 0,018), ali ne u podskupini sveukupne populacije bolesnika s anginom pektoris CCS klase ≥I (n = 14 286) (relativni rizik ivabradin/placebo 1,11, p=0,110).
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 usporenja srčane frekvencije s dozama do 20 mg dva puta na dan, ukazuje na postojanje trenda prema plato učinku, što se slaže sa smanjenim rizikom od teške bradikardije s manje od
The study demonstrated a clinically and statistically significant relative risk reduction of 18% in the rate of the primary composite endpoint of cardiovascular mortality and hospitalisation for worsening heart failure (hazard ratio: 0.82, 95%CI [0.75;0.90] - p<0.0001) apparent within 3 months of initiation of treatment.
Ovo ispitivanje pokazalo je klinički i statistički značajno smanjenje relativnog rizika od 18% za primarni kompozitni ishod: kardiovaskularna smrtnost i hospitalizacija zbog pogoršanja zatajenja srca (omjer ugroženosti (HR): 0.82, 95%CI [0.75;0.90] - p<0.0001), a što je postalo očito unutar prva 3 mjeseca od početka liječenja.
MARKETING AUTHORISATION NUMBER(S) EU/1/05/317/008-014
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/317/008-014
Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Ivabradin je indiciran u kroničnom zatajenju srca stupnja II do IV NYHA klasifikacije sa sistoličkom disfunkcijom, u bolesnika u sinusnom ritmu sa srčanom frekvencijom ≥ 75 otkucaja u minuti u kombinaciji sa standardnom terapijom uključujući terapiju s beta-blokatorom ili kada je primjena beta blokatora kontraindicirana ili se ne podnosi (vidjeti dio 5.1).
Treatment with ivabradine was associated with an average reduction in heart rate of 15 bpm from a baseline value of 80 bpm.
Liječenje s ivabradinom je povezano s prosječnim smanjenjem srčane frekvencije za 15 otkucaja u minuti od početnih 80 otkucaja u minuti.
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.
Nakon tri do četiri tjedna liječenja, ukoliko su u bolesnika još uvijek prisutni simptomi, ukoliko se početna doza dobro podnosi i ako srčana frekvencija u mirovanju ostaje iznad 60 otkucaja u minuti, doza se može povećati na slijedeću višu dozu u bolesnika koji uzimaju 2,5 mg dva puta na dan ili 5 mg dva puta na dan.
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).
Istodobna primjena jakih CYP3A4 inhibitora kao što su azolni antimikotici (ketokonazol, itrakonazol), makrolidni antibiotici (klaritromicin, eritromicin per os, jozamicin, telitromicin), inhibitori proteaze HIVa (nelfinavir, ritonavir) i nefazodona je kontraindicirana (vidjeti dio 4.3).
No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 ml/min (see section 5.2).
U bolesnika s oštećenjem funkcije bubrega i klirensom kreatinina iznad 15 ml/min nije potrebno prilagođavati dozu (vidjeti dio 5.2).
If heart rate is between 50 and 60 bpm, the dose of 5 mg twice daily should be maintained.
Ukoliko je srčana frekvencija između 50 i 60 otkucaja u minuti, potrebno je održavati dozu od 5 mg dva puta na dan.
They particularly occur within the first 2 to 3 months of treatment initiation.
Osobito se javljaju unutar prva 2 ili 3
The maintenance dose should not exceed 7.5 mg twice daily.
Doza održavanja ne smije prelaziti 7,5 mg dva puta na dan.
NAME OF THE MARKETING AUTHORISATION HOLDER Les Laboratoires Servier
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Les Laboratoires Servier
Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist (see section 4.4).
Liječenje se mora prekinuti ako je srčana frekvencija sporija od 50/min ili simptomi bradikardije ustraju (vidjeti dio 4.4).
Treatment of chronic heart failure
Liječenje kroničnog zatajenja srca
After two weeks of treatment, the dose can be increased to 7.5 mg twice daily if resting heart rate is persistently above 60 bpm or decreased to 2.5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension.
Doza se nakon dva tjedna liječenja može povećati na 7,5 mg dva puta na dan ukoliko je srčana frekvencija u mirovanju stalno iznad 60 otkucaja u minuti ili smanjiti na 2,5 mg dva puta na dan (polovica tablete od 5 mg dva puta dnevno) ukoliko je srčana frekvencija u mirovanju stalno ispod 50 otkucaja u minuti ili nastupe simptomi koji su povezani s bradikardijom, kao što su omaglica, umor ili hipotenzija.
A sustained reduction of heart rate was demonstrated in patients treated with ivabradine for at least one year (n = 713).
U bolesnika liječenih ivabradinom najmanje godinu dana, pokazalo se produljeno smanjenje srčane frekvencije (n=713).
The antianginal and anti-ischaemic effects of ivabradine were associated with dose-dependent reductions in heart rate and with a significant decrease in rate pressure product (heart rate x systolic blood pressure) at rest and during exercise.
Antianginalni i antiishemijski učinci ivabradina bili su povezani s usporenjem srčane frekvencije, koje je ovisilo o dozi, te sa značajnim smanjenjem umnoška frekvencije i sistoličkog krvnog tlaka u mirovanju i tijekom fizičkog napora.
Ivabradine must not be initiated in patients with a pre-treatment resting heart rate below 70 beats per minute (see section 4.3).
Primjena u bolesnika s niskom srčanom frekvencijom Ivabradin se ne smije primjenjivati u bolesnika u kojih je prije liječenja srčana frekvencija u mirovanju sporija od 70 otkucaja u minuti (vidjeti dio 4.3).
Musculoskeletal and connective tissue disorders
Poremećaji mišično-koštanog sustava i vezivnog tkiva
Atrial fibrillation has been more common in patients using concomitantly amiodarone or potent class I anti-arrhythmics.
Fibrilacija atrija se češće javlja u bolesnika koji istodobno uzimaju amiodaron ili potentne antiaritmike skupine I.
MARKETING AUTHORISATION NUMBER(S) EU/1/05/317/001-007
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/317/001-007
Ivabradine is contra-indicated for use in patients with severe hepatic insufficiency, since it has not been studied in this population and a large increase in systemic exposure is anticipated (see sections 4.3 and 5.2).
Primjena ivabradina je kontraindicirana u bolesnika s teškom jetrenom insuficijencijom, jer nema kliničkih podataka o primjeni ivabradina u toj populaciji te se očekuje veliko povećanje sustavne izloženosti lijeku (vidjeti dijelove 4.3 i 5.2).
and 45%), ivabradine did not have any deleterious influence on LVEF.
ivabradin nije imao nikakav poguban utjecaj na LVEF.
The Ndesmethylated derivative of ivabradine has been identified as the main active metabolite in humans.
Kao glavni aktivni metabolit u ljudi identificiran je N-desmetilirani derivat ivabradina.
Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction.
Liječenje se mora prekinuti ako srčana frekvencija ostane ispod 50/min ili simptomi bradikardije ustraju usprkos smanjenju doze.
Talk to your doctor or pharmacist before taking Corlentor - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
- ako bolujete od poremećaja srčanog ritma (kao nepravilni rad srca, osjećaj lupanja srca, pojačan bol u prsima) ili fibrilacije atrija (vrsta nepravilnog rada srca) ili abnormalnosti u elektrokardiogramu (EKG) koje se nazivaju “sindrom dugog QT intervala”, - ako imate simptome kao što je umor, omaglica ili nedostatka zraka (to bi moglo značiti da Vam srce radi presporo), - ako imate simptome fibrilacije atrija (puls u mirovanju neuobičajeno visok (iznad 110 otkucaja u minuti) ili nepravilan, bez jasnog razloga, što otežava njegovo mjerenje), - ako ste nedavno imali moždani udar, - ako imate blago ili umjereno niski krvni tlak, - ako bolujete od visokog krvnog tlaka koji nije dobro kontroliran, osobito nakon promjene u terapiji
Ελλάδα
I DOHVATA
The environmental risk assessment of ivabradine has been conducted in accordance to European guidelines on ERA.
Procjena rizika koji ivabradin može imati na okoliš provedena je u skladu s Europskim smjernicama o procjeni rizika koji lijek može imati na okoliš.
Ivabradine may cause transient luminous phenomena consisting mainly of phosphenes (see section 4.8).
Ivabradin može uzrokovati prolazne vidne poremećaje u obliku fosfena (vidjeti dio 4.8).
Measurement of heart rate
Mjerenje srčane frekvencije
A large outcome study, BEAUTIFUL, was performed in 10917 patients with coronary artery disease and left ventricular dysfunction (LVEF<40%) on top of optimal background therapy with 86.9% of patients receiving beta-blockers.
Veliko ispitivanje BEAUTIFUL, provedeno je na 10 917 bolesnika s koronarnom arterijskom bolešću i disfunkcijom lijeve klijetke (LVEF < 40%) koji su primali uobičajenu terapiju, i od kojih je 86,9%
LIST OF EXCIPIENTS Contains lactose monohydrate.
Sadrži laktozu hidrat.
Tel: +420 222 118 111
Servier s.r.o. Tel: +420 222 118 111
Women of childbearing potential
Žene generativne dobi
The concomitant use of ivabradine with these medicinal products is contraindicated (see section 4.3).
Kontraindicirana je istodobna primjena ivabradina s tim lijekovima (vidjeti dio 4.4).
QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol,
- Kardiovaskularni lijekovi koji produljuju QT-interval (npr. kinidin, disopiramid, bepridil, sotalol,
Ivabradine 5 mg twice daily was shown to be effective on exercise test parameters within 3 to 4 weeks of treatment.
U roku od 3 do 4 tjedna liječenja pokazalo se da je ivabradin u dozi od 5 mg dva puta na dan imao učinak na parametre testa fizičkog opterećenja.
Excipient with known effect: 61.215 mg lactose monohydrate For the full list of excipients, see section 6.1.
Pomoćna tvar s poznatim učinkom: 61,215 mg laktoza hidrata
At usual recommended doses, heart rate reduction is approximately 10 bpm at rest and during exercise.
Uz uobičajene preporučene doze, srčana se frekvencija u mirovanju i tijekom fizičkog napora usporava za oko 10 otkucaja u minuti.
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.
Ivabradin je indiciran za simptomatsko liječenje kronične stabilne angine pektoris u odraslih bolesnika s koronarnom arterijskom bolesti s normalnim sinusnim ritmom i sa srčanom frekvencijom ≥ 70 otkucaja u minuti.
Constipation Diarrhoea Abdominal pain*
Bol u abdomenu*
The efficacy of 5 and 7.5 mg twice daily was consistent across studies on exercise test parameters (total exercise duration, time to limiting angina, time to angina onset and time to 1 mm ST segment depression) and was associated with a decrease of about 70% in the rate of angina attacks.
Djelotvornost doza od 5 i 7,5 mg dva puta na dan na parametre testa fizičkog opterećenja bila je postojana tijekom ispitivanja (ukupno trajanje fizičkog opterećenja, vrijeme do ograničavanja angine,
Ivabradine efficacy was fully maintained throughout the 3- or 4-month treatment periods in the efficacy trials.
U ispitivanjima djelotvornosti, ivabradin se pokazao učinkovit tijekom perioda liječenja u trajanju od 3 ili 4 mjeseca.
If heart rate increases persistently above 60 beats per minute at rest, the dose can be up titrated to the next upper dose in patients receiving 2.5 mg twice daily or 5 mg twice daily.
Ukoliko je srčana frekvencija stalno iznad 60 otkucaja u minuti u mirovanju doza se može titrirati na višu u bolesnika koji uzimaju 2,5 mg dva puta dnevno ili 5 mg dva puta dnevno.
An updated RMP should be submitted:
Nadopunjen RMP trebao bi biti dostavljen: • Na traženje Europske agencije za lijekove
Marketing Authorisation Holder and Manufacturer
Nositelj odobrenja za stavljanje u promet gotovog lijeka i proizvođač:
• Obligation to conduct post-authorisation measures
• Obveza provođenja mjera nakon stavljanja lijeka u promet
Angioedema Rash
Angioedem Osip
A specific study to assess the possible influence of ivabradine on driving performance has been performed in healthy volunteers where no alteration of the driving performance was evidenced.
Nije dokazan utjecaj ivabradina na sposobnost upravljanja vozilima tijekom ispitivanja provedenog na zdravim dobrovoljcima.
Eosinophilia
Eozinofilija
Chronic heart failure
Kronično zatajenje srca
Corlentor 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other.
Corlentor 7,5 mg tablete su trokutaste filmom obložene tablete boje lososa s utisnutom oznakom “7.5” na jednoj strani , a na drugoj.