FrancophonIA/ELRC3.0 huggingface dataset:
English: A large outcome study, BEAUTIFUL, was performed in 10,917 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.
Maltese: Studju b'riżultat kbir, BEAUTIFUL, twettaq fost 10,917-il pazjent b'mard tal-arterja koronarja u b'disfunzjoni ventrikulari tax-xellug (LVEF < 40%) b'mod addizzjonali għal terapija ta' sfond ottimali bi 86.9% tal-pazjenti jirċievu beta-blokkers.
English: In a 1,277-patients randomised placebo-controlled study, ivabradine demonstrated a statistically significant additional efficacy on response to treatment (defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill ETT) on top of amlodipine 5 mg o.d. or nifedipine GITS 30 mg o.d. at the trough of drug activity (12 hours after oral ivabradine intake) over a 6-week treatment period (OR = 1.3, 95% CI [1.0 - 1.7]; p = 0.012).
Maltese: Fi studju randomizzat kkontrollat bi plaċebo li involva 1277 pazjent, ivabradine wera effikaċja addizzjonali statistikament sinifikanti fuq ir-rispons għall-kura (definit bħala tnaqqis ta' mill-inqas 3 attakki ta' anġina fil-ġimgħa u/jew żieda fil-ħin sa dipressjoni tassegment ST ta' 1 mm ta' mill- inqas 60 sekonda matul ETT fuq treadmill) flimkien ma' amlodipine 5 mg o.d. jew nifedipine GITS 30 mg o.d fl-inqas punt tal-attività tal-mediċina (12-il siegħa wara it-teħid ta' ivabradine mill-ħalq) fuq perijodu ta' kura ta'6 ġimgħat (OR = 1.3, 95 % CI [1.0-1.7]; p = 0.012).
English: Tablets are available in packs of 14, 28, 56, 84, 98, 100, 112 film-coated tablets.
Maltese: Il-pilloli huma disponibbli f'pakketti ta' 14, 28, 56, 84, 98, 100 jew 112-il pillola miksija b'rita.
English: Ivabradine is eliminated with a main half-life of 2 hours (70 - 75% of the AUC) in plasma and an effective half-life of 11 hours.
Maltese: Ivabradine jitneħħa b'half-life prinċipali ta' sagħtejn (70-75% ta' l-AUC) fil-plażma u halflife effettiva ta' 11-il siegħa.
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 100 film-coated tablets 112 film-coated tablets
Maltese: 14 -il pillola misja b'rita 28 pillola miksija b'rita 56 pillola miksija b'rita 84 pillola miksija b'rita 98 pillola miksija b'rita 100 pillola miksija b'rita 112-il pillola miksija b'rita
English: Ivabradine is contra-indicated in patients with severe hypotension (blood pressure < 90/50 mmHg) (see section 4.3).
Maltese: Ivabradine hu kontra-indikat f'pazjenti b'ipotensjoni severa (pressjoni < 90/50 mm Hg) (ara sezzjoni
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.
Maltese: Studji speċifiċi li saru fuq jekk mediċinali oħra jaqblux ma' dan il-prodott urew li m'hemm l-ebda effett klinikament sinifikanti tal-prodotti mediċinali msemmija hawn taħt fuq ilfarmokokinetika u l- farmakodinamika ta' ivabradine: inibituri proton pump (omeprazole, lansoprazole), sildenafil, inibituri HMG COA reductase (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin u warfarin.
English: Ivabradine Zentiva 7.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ivabradine Zentiva 7.5 mg
English: A 20% heart rate reduction, without bradycardia, was achieved by 69.9% of patients in the ivabradine group versus 12.2% in the placebo group during the titration period of 2 to 8 weeks (Odds Ratio: E = 17.24, 95% CI [5.91 ; 50.30]).
Maltese: Inkiseb tnaqqis ta' 20% fir-rata ta' taħbit tal-qalb, mingħajr bradikardija, f'69.9% talpazjenti fil- grupp ta' ivabradine kontra 12.2% fil-grupp tal-plaċebo matul il-perijodu ta' titrazzjoni ta' 2 sa 8 ġimgħat (Proporzjon ta' Probabbiltà: E = 17.24, 95% CI [5.91 ; 50.30]).
English: Ivabradine is extensively metabolised by the liver and the gut by oxidation through cytochrome P4503A4 (CYP3A4) only.
Maltese: Ivabradine jiġi metabolizzat b'mod estensiv mill-fwied u mill-istonku permezz ta' ossidazzjoni biċ- ċitokromu P450 3A4 (CYP3A4) biss.
English: Very common Luminous phenomena (phosphenes) Common
Maltese: Komuni ħafna Fenomeni mudwali (ċrieki ta' dawl) Komuni
English: Use in patients with AV-block of 2nd degree
Maltese: Imblokk AV tat-2ni grad, imblokk AV tat-3et grad
English: The impact of renal impairment (creatinine clearance from 15 to 60 mL/min) on ivabradine pharmacokinetic is minimal, in relation with the low contribution of renal clearance (about 20%) to total elimination for both ivabradine and its main metabolite S 18982 (see section 4.2).
Maltese: L-impatt ta' indeboliment renali (tneħħija tal-krejatinina minn 15 sa 60 mL/min) fuq ilfarmakokinetika ta' ivabradine huwa minimu, meta mqabbel mal-kontribut baxx ta' tneħħija renali (madwar 20%) ta' l-eliminazzjoni totali kemm ta' ivabradine kif ukoll tas- sustanza prinċipali tagħha fil-metaboliżmu S18982 (ara sezzjoni 4.2).
English: The dose was adapted depending on the therapeutic response with maximum doses of 0.2 mg/kg b.i.d., 0.3 mg/kg b.i.d.
Maltese: Id-doża ġiet adattata skont ir-rispons terapewtiku b'dożi massimi ta' 0.2 mg/kg b.i.d, 0.3 mg/kg darbtejn kuljum u 15 mg b.i.d rispettivament.
English: Uncommon (may affect up to 1 in 100 people) - 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.
Maltese: Palpitazzjoni u taħbit addizzjonali tal-qalb, tħossok ma tiflaħx (nawsja), stitikezza, dijarrea, uġigħ ta' żaqq, sensazzjoni ta' tidwir (vertigo), diffikultà fit-teħid tan-nifs (dispneja), bugħawwiġ, tibdil fil- parametri tal-laboratorju: livelli għoljin ta' aċidu uriku fid-demm, eċċess ta' eosinofili (tip ta' ċelloli bojod tad-demm) u livell għoli ta' kreatinina fid-demm (prodott ta' tkissir tal-muskoli), raxx tal-ġilda, anġjoedema (bħal nefħa fil-wiċċ, ilsien jew griżmejn, diffikultà fit-teħid tan-nifs jew biex tibla'), pressjoni tad-demm baxxa, ħass ħażin, sensazzjoni ta' għeja, sensazzjoni ta' dgħufija, intraċċar mhux normali tal-qalb b'ECG, vista doppja, indeboliment fil-vista.
English: There was an improvement in NYHA class in 37.7% of ivabradine patients versus 25.0% in the placebo group.
Maltese: Kien hemm titjib fil-klassi NYHA f'37.7% talpazjenti li jieħdu ivabradine kontra 25.
English: 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 betablocker therapy or when beta-blocker therapy is contraindicated or not tolerated (see section 5.1).
Maltese: Ivabradine huwa indikat f'insuffiċjenza kronika tal-qalb tal-klassi NYHA II sa IV b'disfunzjoni sistolika, f'pazjenti b'ritmu regolari normali u li r-rata ta' qalbhom hija ≥ 75 bpm, flimkien ma' terapija standard inkluż terapija bil-beta-blokkers jew meta terapija bilbeta-blokkerstkun kontra-indikata jew mhux ittollerata (ara sezzjoni 5.1).
English: In a 889-patients randomised placebo-controlled study, ivabradine given on top of atenolol 50 mg o.d. showed additional efficacy on all ETT parameters at the trough of drug activity (12 hours after oral intake).
Maltese: Fi studju kkontrollat bi plaċebo randomizzat li nvolva 889 pazjent, ivabradine, meta mogħti flimkien ma' atenolol 50 mg o.d. wera effikaċja addizzjonali fuq il-parametri ETT kollha flinqas punt tal- attività tal-mediċina (12-il siegħa wara t-teħid mill-ħalq).
English: - The active substance is ivabradine (as hydrochloride).
Maltese: X'fih Ivabradine Zentiva - Is-sustanza attiva hi ivabradine (bħala hydrochloride).
English: It is used in combination with standard therapy, including beta-blocker therapy or when beta-blockers 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: 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 l-farmakodinamika ta' digoxin, warfarin u fuq il-farmakodinamika ta' aspirin.
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: L-istudju ma wera ebda differenza fir-rata tal-punt ta' tmiem kompost primarju (PCE) fil-grupp ta' ivabradine meta mqabbel mal-grupp tal-plaċebo (riskju relattiv ta' ivabradine/plaċebo 1.08, p=0.197).
English: Ivabradine Zentiva 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ivabradine Zentiva 5 mg
English: How to store Ivabradine Zentiva 6.
Maltese: Kif taħżen Ivabradine Zentiva 6.
English: Uncommon Hyperuricaemia
Maltese: Mhux komuni Iperuricemia
English: Ivabradine is approximately 70% plasma protein bound and the volume of distribution at steady-state is close to 100 L in patients.
Maltese: Ivabradine huwa bejn wieħed u ieħor 70% marbut mal-protejina tal-plażma u l-volum ta' distribuzzjoni fiss huwa viċin ta' 100 1 f'pazjenti.
English: 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].
Maltese: 40,000 pazjent, l-inċidenza ta' fibrillazzjoni atrijali kienet ta' 4.86% f'pazjenti kkurati b'ivabradine meta mqabbel ma' 4.08 % fil-kontrolli, u dan jikkorrispondi għal proporzjon ta' periklu ta' 1.26, 95% CI [1.15-1.39].
English: 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 4.2).
Maltese: Ma kienx hemm differenza farmakokinetika (AUC u Cmax) bejn anzjani (≥ 65 sena) jew anzjani ħafna (≥ 75 sena) u l-popolazzjoni inġenerali (ara sezzjoni 4.2).
English: - Non-cardiovascular QT prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole,
Maltese: - Mediċini mhux kardjovaskulari li jtawwlu l-QT (eż. pimozide, ziprasidone, sertindole,
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% firrata tal- endpoint 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: Additional efficacy of ivabradine in combination with dihydropyridine calcium channel blockers has not been established (see section 5.1).
Maltese: Ivabradine flimkien ma' dihydropyridine calcium channel blockers ma jidhirx li kellu effikaċja addizjonali (ara sezzjoni 5.1).
English: The pharmacokinetic profile of ivabradine in paediatric chronic heart failure patients aged 6 months to less than 18 years is similar to the pharmacokinetics described in adults when a titration scheme based on age and weight is applied.
Maltese: Il-profil farmakokinetiku ta' ivabradine f'pazjenti b'insuffiċjenza kardijaka kronika fit-tfal li għandhom bejn 6 xhur u inqas minn 18-il sena huwa simili għall- farmakokinetika deskritta fl-adulti meta tiġi applikata skema ta' titrazzjoni bbażata fuq l-età u l- piż.
English: A large outcome study, SIGNIFY, was performed in 19,102 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 SHIFT study was a large multicentre, international, randomised double-blind placebo controlled outcome trial conducted in 6,505 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: L-istudju SHIFT kien studju double-blind, multiċentri, internazzjonali, randomizzat, ikkontrollat bi plaċebo, kbir tar-riżultati li sar fuq 6505 pazjent adult bi CHF kronika stabbli (għal ≥ 4 ġimgħat), NYHA 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: 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 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]).
Maltese: Fissubgrupp ta' pazjenti b'HR ≥ 75 bpm u fuq id-doża fil-mira rakkomandata ta' beta-blocker, ma ġie osservat ebda benefiċċju statistikament sinifikanti fuq l-endpoint kompost primarju (proporzjon ta' periklu: 0.97, 95%CI [0.74;1.28]) u endpoints sekondarji oħrajn, inkluż rikoveru l-isptar għal aggravar ta' kollass tal-qalb (proporzjon ta' periklu: 0.79, 95% CI [0.56;1.10]) jew mewta minn kollass tal-qalb (proporzjon ta' periklu: 0.69, 95% CI
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations; ATC code: C01EB17.
Maltese: Terapija kardijaka, prodotti mediċinali oħra kardijaċi, Kodiċi ATC:
English: EU/1/16/1144/008 EU/1/16/1144/009 EU/1/16/1144/010 EU/1/16/1144/011 EU/1/16/1144/012 EU/1/16/1144/013 EU/1/16/1144/014
Maltese: EU/1/16/1144/011 EU/1/16/1144/012 EU/1/16/1144/013 EU/1/16/1144/014
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 tal-anġina, 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: 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: Inibituri moderati ta' CYP3A4 : 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 talqalb 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: Linearity/non linearity The kinetics of ivabradine is linear over an oral dose range of 0.5 - 24 mg.
Maltese: Linearità/nuqqas ta' linearità Il-kinetika ta' ivabradine hija lineari fuq medda ta' doża mill-ħalq ta' 0.5-24 mg.
English: In the subgroup of patients with HR ≥ 75 bpm (n = 4,150), a greater reduction was observed in the primary composite endpoint of 24% (hazard ratio: 0.76, 95% CI [0.68; 0.85], p < 0.0001) and for other secondary endpoints, including all cause death (hazard ratio: 0.83, 95% CI [0.72; 0.96], p = 0.0109) and CV death (hazard ratio: 0.83, 95% CI [0.71; 0.97], p = 0.0166).
Maltese: Fis-sottogrupp ta' pazjenti b'HR ta' ≥ 75 bpm (n=4150), ġie osservat tnaqqis ikbar flendpoint kompost primarju ta' 24 % (proporzjon tal-periklu: 0.76, 95%CI [0.68;0.85]p<0.0001) u għal endpoints sekondarji oħrajn, inkluż il-mewt mill-kawżi kollha (proporzjon tal-periklu: 0.83, 95%CI [0.
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 tal- arterja koronarja b'ritmu sinusali normali u rata tat-taħbit tal-qalb ≥ 70 bpm.
English: - Chronic heart failure in adult patients whose heart rate is over or equal to 75 beats per minute.
Maltese: Insuffiċjenza kronika tal-qalb f'pazjenti adulti li r-rata tal-qalb tagħhom tkun 75 taħbita jew aktar fil-minuta.
English: The metabolism of this active metabolite also involves CYP3A4.
Maltese: Il- metaboliżmu ta' din is-sustanza attiva ffurmata filmetaboliżmu wkoll tinvolvi CYP3A4.
English: Diplopia Visual impairment
Maltese: Viżta mċajpra Mhux komuni Diplopja Indeboliment fil-vista
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: L-użu ta' ivabradine huwa kontraindikat flimkien ma' calcium channel blockers li jbaxxu rritmu tat- taħbit tal-qalb bħal verapamil jew diltiazem (ara sezzjonijiet 4.3 u 4.5).
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: Other medicines and Ivabradine Zentiva
Maltese: Mediċini oħra u Ivabradine Zentiva
English: Posology 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: District 3,
Maltese: U Kabelovny 130
English: rd degree.
Maltese: mg darbtejn kuljum.
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 għall- mediċini http://www.ema.europa.eu
English: Uncommon Elevated creatinine in blood ECG prolonged QT interval Frequency calculated from clinical trials for adverse events detected from spontaneous report.
Maltese: Mhux komuni Kreatinina fid-demm elevata Intervall tal-QT imtawwal tal-ECG * Il-frekwenza hija kkalkolata minn provi kliniċi għal avvenimenti avversi mikxufin minn rapport spontanju
English: In a 725-patients randomised placebo-controlled study, ivabradine did not show additional efficacy on top of amlodipine 10 mg o.d. 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 10 mg o.d. 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: The mean ivabradine doses allowing to achieve a 20% HRR were 0.13±0.04 mg/kg b.i.d., 0.10±0.04 mg/kg b.i.d.
Maltese: Id-dożi medji ta' ivabradine li jippermettu li jintlaħaq HRR ta' 20% kienu 0.13 ± 0.04 mg/kg b.i.d, 0.10 ± 0.04 mg/kg b.i.d u 4.1 ± 2.2 mg b.i.d fis-subsettijiet ta' età ta' [1-3[ snin, [3-18[il sena u <40 kg u [3-18[-il sena u ≥ 40 kg, rispettivament.
English: Ivabradine Zentiva 5 mg film-coated tablets are oblong, one side and both edges scored white tablets with dimensions 4.8×8.8 mm.
Maltese: Kif jidher Ivabradine Zentiva u l-kontenut tal-pakkett Ivabradine Zentiva 5 mg pilloli miksijin b'rita huma bojod, oblunga, naħa waħda u ż-żewġ trufijiet imnaqqxa b'daqsijiet ta' 4.8×8.8 mm.
English: 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 biss għall-kura sintomatika ta' anġina pectoris kronika stabbli peress li ivabradine ma għandu ebda benefiċċju fuq eżiti kardjovaskulari (eż. infart mijokardijaku jew mewta kardjovaskulari) (ara sezzjoni 5.1).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.>
English: Pharmacokinetic/pharmacodynamic (PK/PD) relationship 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: Ir-relazzjoni farmakokinetika/farmakodinamika (PK/PD) Analiżi ta' relazzjoni PK/PD wriet li r-rata tat-taħbit tal-qalb tonqos b'mod kważi lineari meta tiżdied il-konċentrazzjoni fil-plażma, ta' ivabradine u ta' S18982 għal dożi sa 15-20
English: How to store Ivabradine Zentiva
Maltese: Kif jaħdem Ivabradine Zentiva
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
Maltese: Analiżi ta' tnaqqis fir-rata tat-taħbit talqalb b'doża sa 20 mg darbtejn kuljum tindika tendenza lejn effett ta' plateau konsistenti ma' riskju inqas ta' bradikardija severa ta' inqas minn 40 bpm (ara sezzjoni 4.8).
English: Ivabradine Zentiva 7.5 mg film-coated tablets: White to off white, round tablet with diameter 7.1 mm.
Maltese: Ivabradine Zentiva 7.5 mg pilloli miksija b'rita huma bojod għal bojod fl-isfar, tondi b'dijametru ta' 7.1 mm.
English: In a post-hoc subgroup of patients with symptomatic angina at randomisation (n = 1,507), 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.