FrancophonIA/ELRC3.0 huggingface dataset:
English: Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle cramps, changes in laboratory parameters : high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.
Slovenian: Palpitacije in dodatni srčni utripi, občutek slabosti (navzea), zaprtje, driska, bolečina v trebuhu, občutek vrtoglavosti (vertigo), oteženo dihanje (dispneja), mišični krči, spremembe laboratorijskih parametrov: visoke vrednosti sečne kisline v krvi, preveliko število eozinofilcev (vrsta belih krvnih celic) in povečanje kreatinina v krvi (razgradni produkt mišic), kožni izpuščaj, angioedem (kot je otečen obraz, jezik ali grlo, težave pri dihanju ali požiranju), nizek krvni tlak, omedlevica, občutek utrujenosti, občutek šibkosti,
English: Concomitant use with precautions - Moderate CYP3A4 inhibitors: the concomitant use of ivabradine with other moderate CYP3A4 inhibitors (e.g. fluconazole) may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 70 bpm, with monitoring of heart rate.
Slovenian: Sočasno jemanje ob previdnostnih ukrepih - Zmerni zaviralci citokroma P450 3A4: o sočasnem jemanju ivabradina z drugimi zmernimi zaviralci citokroma P450 3A4 (na primer flukonazolom) se lahko odločate ob začetnem odmerku 2,5 mg dvakrat na dan in če je srčna frekvenca med mirovanjem nad 70 utripov na minuto, ob spremljanju srčne frekvence.
English: In the ivabradine group, 67% of patients were treated with 7.5 mg twice a day.
Slovenian: V skupini, ki je jemala ivabradin, je 67 % bolnikov prejemalo 7,5 mg dvakrat na dan. Mediana trajanja spremljanja je bila 22,9 mesecev.
English: Treatment with ivabradine was associated with an average reduction in heart rate of 15 bpm from a baseline value of 80 bpm.
Slovenian: Zdravljenje z ivabradinom je bilo povezano s povprečnim znižanjem srčne frekvence za 15 utripov na minuto od izhodiščne vrednosti 80 utripov na minuto.
English: Ivabradine can interact also with the retinal current Ih which closely resembles cardiac If.
Slovenian: Ivabradin lahko medsebojno deluje tudi z mrežničnim tokom Ih, ki je zelo podoben srčnemu If.
English: A significant effect was observed on the primary composite endpoint in the overall group of patients receiving beta blocker therapy (hazard ratio: 0.85, 95%CI [0.76;0.94]).
Slovenian: Znaten učinek je bil opažen pri primarnem sestavljenem izidu v celotni skupini bolnikov, ki je prejemala antagonist adrenergičnih receptorjev beta (razmerje tveganja: 0,85, 95 % interval zaupanja [0,76; 0,94]).
English: 0.5% of patients experienced a severe bradycardia below or equal to 40 bpm.
Slovenian: 0,5 % bolnikov je doživelo hudo bradikardijo s 40 utripi na minuto ali manj.
English: If you are being treated for chronic heart failure
Slovenian: Če se zdravite zaradi kroničnega srčnega popuščanja
English: Patients received standard care including beta-blockers (89 %), ACE inhibitors and/or angiotensin II antagonists (91 %), diuretics (83 %), and anti-aldosterone agents (60 %).
Slovenian: (89 %), zaviralce ACE in/ali antagoniste angiotenzina II (91 %), diuretike (83 %) in antagoniste aldosterona (60 %).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/317/001-007
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/317/001-007
English: Ivabradine is extensively metabolised by the liver and the gut by oxidation through cytochrome P450 3A4 (CYP3A4) only.
Slovenian: Ivabradin se obširno presnavlja v jetrih in črevesju z oksidacijo samo prek citokroma P450 3A4.
English: - The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E 470 B), maize starch, maltodextrin, colloidal anhydrous silica (E 551), and in the tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470 B), yellow iron oxide (E 172), red iron oxide (E 172).
Slovenian: - Pomožne snovi so: laktoza monohidrat, magnezijev stearat (E 470 B), koruzni škrob, maltodekstrin, brezvodni koloidni silicijev dioksid (E 551) v jedru tablete in hipromeloza (E 464), titanov dioksid (E 171), makrogol 6000, glicerol (E 422), magnezijev stearat (E 470 B), rumeni železov oksid
English: 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).
Slovenian: 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
English: 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.
Slovenian: 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.
English: CYP3A4 inhibitors and inducers are liable to interact with ivabradine and influence its metabolism and pharmacokinetics to a clinically significant extent.
Slovenian: Zaviralci in spodbujevalci citokroma P450 3A4 lahko medsebojno delujejo z ivabradinom ter klinično signifikantno vplivajo na njegovo presnovo in farmakokinetiko.
English: The main efficacy criterion was the composite of cardiovascular death or non-fatal MI.
Slovenian: Poglavitno merilo učinkovitosti je bil sestavljen izid srčno žilne umrljivosti ali neusodnega miokardnega infarkta.
English: How to take Corlentor
Slovenian: Kako jemati zdravilo Corlentor
English: It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers.
Slovenian: ki ne prenašajo ali ne morejo jemati zdravil za srce, imenovanih antagonisti receptorjev beta.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: It is used in combination with standard therapy, including beta-blocker therapy or when betablockers are contraindicated or not tolerated.
Slovenian: 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.
English: Do not take Corlentor if you are breast-feeding (see “Do not take Corlentor”).
Slovenian: Ne jemljite zdravila Corlentor, če dojite (glejte “Ne jemljite zdravila Corlentor”).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Corlentor with food and drink Avoid grapefruit juice during treatment with Corlentor.
Slovenian: Med zdravljenjem z zdravilom Corlentor se izogibajte uživanju grenivkinega soka.
English: Rare: Urticaria, itching, skin reddening, feeling unwell.
Slovenian: Koprivnica, srbenje, rdečica kože, občutek slabosti.
English: Therefore, ivabradine is contra-indicated during breast-feeding (see section 4.3).
Slovenian: Ivabradin je torej kontraindiciran med dojenjem (glejte poglavje 4.3).
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema občasni eozinofilija
English: The concomitant use of ivabradine with these medicinal products is contraindicated (see section 4.3).
Slovenian: Sočasno jemanje ivabradina s tovrstnimi zdravili je kontraindicirano (glejte poglavje 4.3).
English: 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.
Slovenian: 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.
English: The combination of ivabradine 10 mg twice daily with St John's Wort was shown to reduce ivabradine AUC by half.
Slovenian: Opazili so, da kombinacija ivabradina 10 mg dvakrat na dan s šentjanževko zmanjšuje njegovo površino pod krivuljo (AUC) za polovico.
English: 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).
Slovenian: 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.
English: 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).
Slovenian: (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).
English: For the different doses, film-coated tablets containing 5 mg and 7.5 mg ivabradine are available.
Slovenian: Za različna odmerjanja so na voljo filmsko obložene tablete, ki vsebujejo 5 mg in 7,5 mg ivabradina.
English: Ivabradine influences on retinal function (see section 5.1).
Slovenian: Funkcija vida Ivabradin vpliva na delovanje mrežnice (glejte poglavje 5.1).
English: In the SIGNIFY study atrial fibrillation was observed in 5.3% of patients taking ivabradine compared to 3.8% in the placebo group.
Slovenian: V študiji SIGNIFY so opažali atrijsko fibrilacijo pri 5,3 % bolnikov, ki so jemali ivabradin, v primerjavi s
English: In the event of bradycardia with poor haemodynamic tolerance, symptomatic treatment including intravenous betastimulating medicinal products such as isoprenaline may be considered.
Slovenian: Če imajo bolniki bradikardijo s slabim hemodinamičnim prenašanjem, razmislite o simptomatskem zdravljenju, vključno z intravenskimi spodbujevalci receptorjev beta, kot je izoprenalin.
English: 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).
Slovenian: 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).
English: Luminous phenomena (phosphenes)
Slovenian: Očesne bolezni zelo pogosti pojavi svetlikanja (fosfeni)
English: - CYP3A4 inducers: CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin, Hypericum perforatum [St John's Wort]) may decrease ivabradine exposure and activity.
Slovenian: - Spodbujevalci citokroma P450 3A4: spodbujevalci citokroma P450 3A4 (na primer rifampicin, barbiturati, fenitoin, Hypericum perforatum [šentjanževka]) lahko zmanjšujejo izpostavljenost ivabradinu in njegovo aktivnost.
English: Very rare
Slovenian: Zelo redki:
English: Treatment of chronic heart failure
Slovenian: Zdravljenje kroničnega srčnega popuščanja
English: Measurement of heart rate
Slovenian: Merjenje srčne frekvence
English: Irregular rapid contraction of the heart, abnormal perception of heartbeat, uncontrolled blood pressure, headache, dizziness and blurred vision (cloudy vision).
Slovenian: Neredne, hitre kontrakcije srčne mišice, nenormalno zaznavanje srčnega utripa, nenadzorovan krvni tlak,
English: 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.
Slovenian: 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.
English: United Kingdom Servier Laboratories Ltd Tel: +44 (0)1 753 666409
Slovenian: Servier Laboratories Ltd Tel: +44 (0)1 753 666409
English: Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.
Slovenian: Bolnike s kroničnim srčnim popuščanjem z motnjami intraventrikularne prevodnosti (levokračni blok, desnokračni blok) in prekatno dissinhronijo je potrebno pozorno spremljati.
English: As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your doctor before stopping this medicinal product.
Slovenian: 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.
English: The intake of St John's Wort should be restricted during the treatment with ivabradine.
Slovenian: Uživanje šentjanževke morate med zdravljenjem z ivabradinom omejiti.
English: A large dose of Corlentor could make you feel breathless or tired because your heart slows down too much.
Slovenian: Če ste vzeli večji odmerek zdravila Corlentor, kot bi smeli Velik odmerek zdravila Corlentor bi lahko povzročil zasoplost ali utrujenost, ker preveč upočasni srce.
English: 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 %).
Slovenian: (absolutno zmanjšanje tveganja za 4,7 %) in umrljivosti zaradi srčnega popuščanja (absolutno zmanjšanje tveganja za 1,1 %).
English: No safety issue has been raised on the combination of ivabradine with nitrates and dihydropyridine calcium channel blockers such as amlodipine.
Slovenian: Pri kombinaciji ivabradina z nitrati in dihidropiridinskimi kalcijevimi antagonisti, kot je amlodipin, niso opažali težav z varnostjo.
English: Tablets must be taken orally twice daily, i.e. once in the morning and once in the evening during meals (see section 5.2).
Slovenian: Način uporabe Tablete morajo bolniki jemati peroralno dvakrat na dan, to je eno zjutraj in eno zvečer med obrokom
English: 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).
Slovenian: 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).
English: Use in patients with AV-block of 2nd degree Ivabradine is not recommended in patients with AV-block of 2nd degree.
Slovenian: Ivabradin ni priporočljiv pri bolnikih z atrioventrikularnim blokom 2. stopnje.
English: 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.
Slovenian: 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.
English: Ivabradine is the S-enantiomer with no bioconversion demonstrated in vivo.
Slovenian: S-enantiomer in ni dokazov za njegovo biološko konverzijo in vivo.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni mišični krči
English: 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).
Slovenian: 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).
English: Excipient with known effect: 61.215 mg lactose monohydrate For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: 61,215 mg laktoze monohidrata.
English: 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).
Slovenian: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do
English: Diplopia Visual impairment
Slovenian: diplopija okvara vida
English: Skin and subcutaneous tissue Uncommon*
Slovenian: Bolezni kože in podkožja občasni*
English: The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.
Slovenian: Najpogostejši simptomi srčnega popuščanja vključujejo zasoplost, slabotnost,
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Do not take Corlentor if you are pregnant or are planning to have a baby (see “Do not take Corlentor”).
Slovenian: Nosečnost in dojenje Ne jemljite zdravila Corlentor, če ste noseči ali če načrtujete nosečnost (glejte “Ne jemljite zdravila
English: ECG prolonged QT interval * Frequency calculated from clinical trials for adverse events detected from spontaneous report
Slovenian: *Pogostnost neželenih učinkov iz spontanega poročanja je izračunana na podlagi podatkov iz kliničnih študij Opis izbranih neželenih učinkov
English: Cardiac arrhythmias
Slovenian: Možganska kap
English: 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.
Slovenian: V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
English: Syncope, possibly related to bradycardia
Slovenian: sinkopa, možno zaradi bradikardije
English: 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.
Slovenian: 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.
English: Excipient with known effect: 63.91 mg lactose monohydrate For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: 63,91 mg laktoze monohidrata.
English: Uncontrolled blood pressure
Slovenian: Žilne bolezni pogosti nenadzorovan krvni tlak občasni*
English: Cessation of treatment should be considered if any unexpected deterioration in visual function occurs.
Slovenian: Če se pojavi kakršnokoli nepričakovano poslabšanje funkcije vida, razmislite o prekinitvi zdravljenja.