FrancophonIA/ELRC3.0 huggingface dataset:
English: Przedsiebiorstwo Farmaceutyczne ANPHARM S.A. ul.
Maltese: Wicklow, L-Irlanda Przedsiebiorstwo Farmaceutyczne ANPHARM
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/317/001-007
Maltese: EU/1/05/317/001-007
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.
Maltese: Ivabradine huwa indikat għall-kura tas-sintomi ta' angina pectoris kronika stabbli f'adulti b'mard talarterja koronarja b'ritmu sinusali normali u rata tat-taħbit tal-qalb ≥ 70 bpm.
English: It is used in combination with standard therapy, including beta-blocker therapy or when betablockers are contraindicated or not tolerated.
Maltese: Jintuża flimkien ma' terapija standard, inkluż terapija beta-blocker jew meta l imblokkaturi tar-riċetturi beta jkunu kontra-indikati jew mhux tollerati.
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Maltese: - Mediċini mhux kardjovaskulari li jtawwlu l-QT (eż. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, erythromycin ġol-vini).
English: Visual function
Maltese: Funzjoni viżwali
English: Luminous phenomena (phosphenes) were reported by 14.5% of patients, described as a transient enhanced brightness in a limited area of the visual field.
Maltese: Fenomeni mudwali (ċrieki ta'dawl) ġew irrapportati minn 14.5% tal-pazjenti, jiddeskrivu luminożita qawwija ta' dawl temporanju limitat fil-qasam viżiv.
English: Corlentor 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other.
Maltese: Corlentor 7.5 mg pilloli huma pilloli miksija b'rita, kulur is-salamun, triangulari, imnaqqxin b'“7.5” fuq naħa waħda u b' fuq in-naħa l-oħra.
English: Corlentor 5 mg film-coated tablets Corlentor 7.5 mg film-coated tablets ivabradine
Maltese: Corlentor 5 mg pilloli miksija b'rita Corlentor 7.5 mg pilloli miksija b'rita ivabradine
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations, ATC code: C01EB17.
Maltese: Terapija kardijaka, prodotti mediċinali oħra kardijaċi, Kodiċi ATC:
English: Avda.
Maltese: ul.
English: Children Corlentor is not intended for use in children and adolescents younger than 18 years.
Maltese: Tfal Corlentor mhuwiex intenzjonat sabiex jintuża fi tfal u adoloxxenti ta' inqas minn 18-il sena.
English: 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.
Maltese: L-istudju wera tnaqqis relattiv fir-riskju klinikament u statistikament sinifikanti ta' 18% fir-rata talendpoint kompost primarju tal-mortalità kardjovaskulari u rikoveru l-isptar għal taħżin fl-insuffiċjenza tal-qalb (proporzjon tal-periklu: 0.82, 95%CI [0.75;0.90] - p<0.0001) li deher fi żmien 3 xhur mill-bidu tal-kura.
English: In the ivabradine group, 67% of patients were treated with 7.5 mg twice a day.
Maltese: Fil grupp li ngħata ivabradine, 67% tal-pazjenti ngħataw 7.5 mg darbtejn kuljum.
English: Combination with calcium channel blockers
Maltese: Użu flimkien ma' imblokkaturi tal-kanal tal-kalċju
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallmediċini http://www.ema.europa.eu/
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.
Maltese: Sar studju kbir tar-riżultati, SIGNIFY, f'19,102 pazjenti b'mard tal-arterja koronarja u klinikament mingħajr insuffiċjenza tal-qalb (LVEF > 40%), flimkien ma' terapija ta' sfond ottimali.
English: 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.
Maltese: L-effikaċja ta' dożi ta' 5 mg u 7.5 mg darbtejn kuljum kienet konsistenti fi studji fuq il parametri tat-test ta' eżerċizzju fiżiku (tul totali ta' ħin ta' eżerċizzju fiżiku, ħin għal-limitazzjoni talanġina, ħin ta' bidu ta' anġina, ħin ta' dipressjoni ta' 1mm fil-parti ST) u kien assoċjat ma' tnaqqis ta' madwar 70% fir-rata tal-attakki tal-anġina.
English: The average plasma concentration is 10 ng/ml (CV=38%) at steady-state.
Maltese: Il-medja ta' konċentrazzjoni fil plażma fissa hija ta' 10 ng/mL ( CV = 38%).
English: In the event of bradycardia with poor haemodynamic tolerance, symptomatic treatment including intravenous betastimulating medicinal products such as isoprenaline may be considered.
Maltese: F'każ ta' bradikardija b'tolleranza emodinamika, kura sintomatika inkluż prodotti mediċinali beta stimulanti fil-vina bħal isoprenaline tista' tiġi ikkunsidrata.
English: Corlentor with food and drink Avoid grapefruit juice during treatment with Corlentor.
Maltese: Evita li tieħu il-meraq tal-grejpfrut meta tkun qed tieħu Corlentor.
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]).
Maltese: Ġie osservat effett sinifikanti fuq l-endpoint kompost primarju fil-grupp ġenerali ta' pazjenti li jirċievu terapija b'beta blocker (proporzjon ta' periklu: 0.85, 95%CI [0.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Les Laboratoires Servier
Maltese: Les Laboratoires Servier
English: For the different doses, film-coated tablets containing 5 mg and 7.5 mg ivabradine are available.
Maltese: Għad-dożi differenti hemm disponibbli pilloli miksija b'rita li fihom 5 mg u 7.5 mg ivabradine.
English: In a 725-patients randomised placebo-controlled study, ivabradine did not show additional efficacy on top of amlodipine at the trough of drug activity (12 hours after oral intake) while an additional efficacy was shown at peak (3-4 hours after oral intake).
Maltese: Fi studji kliniċi randomised kontrollati bil-placebo fuq 725 pazjenti ivabradine ma kellux effikaċja aktar minn amlodipine fl-attività tal-mediċina fl-inqas ħin (12-il siegħa wara li jittieħed mill-ħalq) waqt li kien hemm aktar effikaċja fl-aqwa ħin (3-4 sigħat wara li jittieħed mill-ħalq).
English: Ivabradine has low affinity for CYP3A4, shows no clinically relevant CYP3A4 induction or inhibition and is therefore unlikely to modify CYP3A4 substrate metabolism or plasma concentrations.
Maltese: Ivabradine għandu affinità baxxa għal CYP3A4, m'għandux induzzjoni u lanqas impedizzjoni klinikament relevanti ta' CYP3A4 u għalhekk mhux mistenni li jbiddel il-livell ta' sustanza li tiġi metabolizzata minn CYP3A4 jew ilkonċentrazzjonijiet fil-plażma.
English: In the SIGNIFY study atrial fibrillation was observed in 5.3% of patients taking ivabradine compared to 3.8% in the placebo group.
Maltese: Fl-istudju SIGNIFY, ġiet osservata fibrillazzjoni atrijali f'5.3% tal-pazjenti li kienu qed jieħdu ivabradine meta mqabbel ma' 3.8% fil-grupp tal-plaċebo.
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).
Maltese: F'subgrupp post-hoc ta' pazjenti b'anġina sintomatika f'randomizzazzjoni (n=1507), ma ġie identifikat ebda sinjal ta' sigurtà fir-rigward ta' mewta kardjovaskulari, rikoveru l-isptar għal MI akuta jew insuffiċjenza tal-qalb (ivabradine 12.0% kontra plaċebo 15.
English: The major active metabolite is the N-desmethylated derivative (S 18982) with an exposure about 40% of that of the parent compound.
Maltese: N-desmethylated ( S18982) ma' kxif ta' madwar 40% tal-prodott mediċinali oriġinali.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Resting heart rate below 70 beats per minute prior to treatment - Cardiogenic shock - Acute myocardial infarction - Severe hypotension (< 90/50 mmHg) - Severe hepatic insufficiency - Sick sinus syndrome - Sino-atrial block - Unstable or acute heart failure - Pacemaker dependent (heart rate imposed exclusively by the pacemaker) - Unstable angina - AV-block of 3rd degree - Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals
Maltese: - Infart mijokardijaku akut - Ipotensjoni severa (< 90/50 mmHg) - Indeboliment sever tal-fwied - Sindromu sick sinus - Imblokk sino-atrijali - Insuffiċjenza tal-qalb instabbli jew akuta - Pazjenti dipendenti fuq pace maker (ir-rata tal-qalb imposta esklussivament mill-pacemaker)
English: No safety issue has been raised on the combination of ivabradine with nitrates and dihydropyridine calcium channel blockers such as amlodipine.
Maltese: Ma deherx li ivabradine flimkien ma' nitrates u ma' dihydropyridine calcium channel blockers bħal amlodipine jagħmel ħsara.
English: Bradycardia was reported by 17.9 % of patients in the ivabradine group (2.1% in the placebo group).
Maltese: Ġiet irrapportata bradikardija minn 17.9% tal-pazjenti fil-grupp ta' ivabradine (2.1% fil-grupp tal-plaċebo). 7.1% tal-pazjenti ngħataw verapamil, diltiazem jew inibituri qawwija ta' CYP 3A4 waqt l-istudju.
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).
Maltese: L-użu flimkien ta' impedituri qawwija ta' CYP3A4 bħal antifungali ta' tip azole (ketoconazole, itraconazole), antibijotiċi makrolidi (clarithromycin, erythtromycin per os, josamycin, telithromycin),
English: Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist (see section 4.4).
Maltese: 50 bpm jew sintomi ta' bradikardija jippersistu (ara sezzjoni 4.2).
English: 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.
Maltese: Impedituri ta' CYP3A4 moderati: studji speċifiċi ta' interazzjoni fuq voluntiera b'saħħithom u f'pazjenti wrew li l-użu flimkien ta' ivabradine mal-mediċini li jnaqqsu r-rata tat-taħbit tal-qalb diltiazem jew verapamil irriżulta f'żieda fl-esponiment għal ivabradine (żieda minn 2 sa 3 darbiet fl-AUC) u nuqqas addizzjonali fir-ritmu tat-taħbit tal-qalb ta' 5 bpm.
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.
Maltese: Analiżi ta' relazzjoni PK/PD wriet li r-rata tat-taħbit tal-qalb tonqos b'mod kważi lineari meta tiżdied ilkonċentrazzjoni fil-plażma, ta' ivabradine u ta' S18982 għal dożi sa 15-20 mg darbtejn kuljum.
English: Ivabradine 5 mg twice daily was shown to be effective on exercise test parameters within 3 to 4 weeks of treatment.
Maltese: Deher li ivabradine 5 mg darbtejn kuljum kien effikaċi fuq il-parametri tat-test ta' eżerċizzju fiżiku wara 3-4 ġimgħat ta' kura.
English: The study showed no difference in the rate of the primary composite outcome in the ivabradine group by comparison to the placebo group (relative risk ivabradine:placebo 1.00, p=0.945).
Maltese: L-istudju ma wera ebda differenza fir-rata tar-riżultat kompost primarju fil-grupp tal-ivabradine meta mqabbel mal-grupp tal-plaċebo (riskju relattiv ivabradine:plaċebo 1.00, p=0.945).
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).
Maltese: ivabradine/plaċebo 1.08, p=0.197).
English: Special populations - Older people: no pharmacokinetic differences (AUC and Cmax) have been observed between elderly (≥ 65 years) or very elderly patients (≥ 75 years) and the overall population (see section
Maltese: Popolazzjonijiet speċjali - Persuni akbar fl-età: ma kienx hemm differenza farmakokinetika (AUC u Cmax) bejn anzjani (≥ 65
English: Rash
Maltese: IS-SIBT
English: The twice-daily dosing regimen of ivabradine gave uniform efficacy over 24 hours.
Maltese: Id-doża ta' darbtejn kuljum ta' ivabradine tat effikaċja konistenti tul 24 siegħa.
English: Core
Maltese: Qalba
English: Syncope, possibly related to bradycardia
Maltese: Mhux komuni* Sinkope, possibbilment relatata ma' bradikardija
English: 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).
Maltese: Ivabradine huwa indikat għall-kura sintomatika ta' anġina pectoris kronika stabbli peress li ivabradine ma għandu ebda benefiċċju fuq eżiti kardjovaskulari (eż. infart mijokardijaku jew mewta kardjovaskulari)
English: The total clearance is about 400 ml/min and the renal clearance is about 70 ml/min.
Maltese: 70 mL/min.
English: Potassium-depleting diuretics (thiazide diuretics and loop diuretics): hypokalemia can increase the risk of arrhythmia.
Maltese: Dijuretiċi li jnaqqsu l-potassju (dijuretiċi thiazidic u dijuretiċi loop): ipokalemija tista' żżid ir-riskju ta' arrittmija.
English: One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride)
Maltese: U KWANTITATTIVA Pillola waħda miksija b'rita fiha 7.5 mg ivabradine (ekwivalenti għal 8.085 mg ivabradine hydrochloride)
English: The antianginal and anti-ischaemic efficacy of ivabradine was studied in five double-blind randomised trials (three versus placebo, and one each versus atenolol and amlodipine).
Maltese: L-effikaċja kontra l-anġina u kontra l-iskemija ta' ivabradine ġiet studjata f'ħames provi randomised għamja doppji (tlieta versus plaċebo, wieħed versus atenolol u wieħed versus amlodipine).
English: NAME OF THE MEDICINAL PRODUCT Corlentor 5 mg film-coated tablets ivabradine
Maltese: Corlentor 5 mg pilloli miksija b'rita ivabradine
English: Increased plasma concentrations of ivabradine may be associated with the risk of excessive bradycardia (see section 4.4).
Maltese: Żieda fil-konċentrazzjoni tal-plażma ta' ivabradine tista' tiġi assoċjata mar-riskju ta' bradikardija eċċessiva (ara sezzjoni 4.4).
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).
Maltese: Mhemmx informazzjoni biżżejjed dwar pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 4.2 u 4.3).
English: (5 mg b.i.d, if age ≥
Maltese: 5 mg darbtejn kuljum).
English: NAME OF THE MEDICINAL PRODUCT Corlentor 7.5 mg film-coated tablets ivabradine
Maltese: Corlentor 7.5 mg pilloli miksija b'rita ivabradine
English: The antianginal and anti-ischaemic efficacy of ivabradine was preserved in diabetic patients (n = 457) with a similar safety profile as compared to the overall population.
Maltese: L-effikaċja ta' ivabradine kontra l-anġina u kontra l-iskemija nżammet f'pazjenti dijabetiċi (n = 457) bl istess profil ta' sigurtà meta mqabbla mal-popolazzjoni inġenerali.
English: Since tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Minħabba li l-pilloli fihom il-lactose, pazjenti bi problemi ereditarji rari ta' intolleranza ta' galactose,
English: The Ndesmethylated derivative of ivabradine has been identified as the main active metabolite in humans.
Maltese: N-desmethylated ta' ivabradine ġie identifikat bħala s-sustanza attiva maġġura ffurmata fil-metaboliżmu fil-bniedem.
English: Stroke
Maltese: TIKKETTAR
English: One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Maltese: U KWANTITATTIVA Pillola waħda miksija b'rita fiha 5 mg ivabradine (ekwivalenti għal 5.390 mg ivabradine hydrochloride)
English: 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.
Maltese: f'pazjenti b'ritmu regolari normali u li r-rata ta' qalbhom hija ≥ 75 bpm, flimkien ma' terapija standard inkluż terapija beta-blocker jew meta terapija beta-blocker tkun kontra-indikata jew mhux tollerata (ara sezzjoni 5.1).
English: 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.
Maltese: Barra minn hekk, ma kienx kemm effett klinikament sinifikanti ta' ivabradine fuq il-farmakokinetika ta' simvastatin, amlodipine, lacidipine fuq il-farmakokinetika u lfarmakodinamika ta' digoxin, warfarin u fuq il-farmakodinamika ta' aspirin.
English: 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.
Maltese: żieda fl-uġigħ fis-sider) jew fibrillazzjoni atrijali sostnuta (tip ta' taħbita tal-qalb irregolari), jew anormalità ta' elettrokardjogramma (ECG) imsejħa 'sindromu QT imtawwal', - jekk għandek sintomi ta' għejja, sturdament jew qtugħ ta' nifs (dan jista' jfisser li għandek il-qalb qed tħabbat bil-mod ħafna),
English: Ivabradine was shown not to influence the metabolism and plasma concentrations of other CYP3A4 substrates (mild, moderate and strong inhibitors).
Maltese: Ivabradine ma jinfluwenzax il-metaboliżmu u l-konċentrazzjoni fil-plażma ta' sustanzi oħra li fuqhom jaħdem CYP3A4 (impedituri dgħajfa, moderati u qawwija).
English: The most common adverse reactions with ivabradine, luminous phenomena (phosphenes) and bradycardia, are dose dependent and related to the pharmacological effect of the medicinal product.
Maltese: L-aktar reazzjonijiet avversi komuni b'ivabradine, fenomeni mudwali (ċrieki ta' dawl) u bradikardja huma dawk li jiddependu mid-doża u relatati mal-effett farmakoloġiku tal-prodott mediċinali.
English: Angioedema disorders
Maltese: - Anġina instabbli
English: Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided (see section 4.5).
Maltese: L-użu ta' ivabradine f'pazjenti li jbatu minn sindromu QT konġenitali jew li qegħdin jieħdu kura bi prodotti mediċinali li jtawwlu l-QT għandu jiġi evitat (ara sezzjoni 4.5).
English: Symptoms Overdose may lead to severe and prolonged bradycardia (see section 4.8).
Maltese: Doża eċċessiva tista' twassal għal bradikardija severa u fit-tul (ara sezzjoni 4.8).
English: 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.
Maltese: Din l-informazzjoni hija konsistenti mal-effett farmakoloġiku ta' ivabradine relatat ma' l-interazzjoni tiegħu ma' iperpolarizzazzjoni-attivata tal-kurrenti Ih fir-retina, li jaqsmu omoloġija estensiva ma' kurrent If tal pacemaker tal-qalb.
English: Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.
Maltese: Il-pazjenti li jkollhom insuffiċjenza kronika tal-qalb b'difetti fil-konduzzjoni intraventrikolari (imblokk fil-bundle branch tax-xellug, imblokk fil-bundle branch tal-lemin) u dissinkronija ventrikolari għandhom jiġu mmonitorjati mill-qrib.
English: Laboratorios Servier, S.L.
Maltese: Servier Laboratories (Ireland) Ltd.
English: Therefore, ivabradine is contra-indicated during breast-feeding (see section 4.3).
Maltese: Għalhekk ivabradine huwa kontraindikat waqt it-treddigħ (ara sezzjoni 4.3).
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common: may affect up to 1 in 10 people uncommon: may affect up to 1 in 100 people rare: may affect up to 1 in 1,000 people very rare: may affect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
Maltese: komuni: tista' taffettwa sa persuna 1 minn kull 10 mhux komuni: tista' taffettwa sa persuna 1 minn kull 100 rari: tista' taffettwa sa persuna 1 minn kull 1000
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.
Maltese: tal-klassi II sa IV, fi frazzjoni mnaqqsa tat-tfigħ mill-ventrikolu tax-xellug (LVEF ≤ 35%) u rata tal-qalb waqt il-mistrieħ ta' ≥ 70 bpm.
English: No influence on glucose or lipid metabolism was observed.
Maltese: Ma ġie osservat ebda effett fuq il-metaboliżmu tal-glucose jew tal-lipidi.
English: Linearity/non linearity The kinetics of ivabradine is linear over an oral dose range of 0.5 - 24 mg.
Maltese: Il-kinetika ta' ivabradine hija lineari fuq medda ta' doża mill-ħalq ta' 0.5-24 mg.
English: Magyarország Servier Hungaria Kft. Tel.: + 36 1 238 77 99
Maltese: Tel.: + 36 1 238 77 99
English: Ivabradine is indicated : - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta blocker dose.
Maltese: - f'adulti li ma jistgħux jittolleraw jew li għandhom kontra-indikazzjoni għall-użu ta' beta-blockers - jew f'kombinazzjoni ma' beta-blockers f'pazjenti li mhumiex ikkontrollati adegwatament b'doża ottimali ta' beta-blocker.
English: Dyspnoea
Maltese: FOLJA