FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: - all other medicines to treat diabetes, - angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever), - sulfonamide antibiotics.
Maltese: Il-mediċini li jistgħu jbaxxu l-livell taz-zokkor f'demmek (ipogliċemija) jinkludu: - il-mediċini l-oħra kollha użati għall-kura tad-dijabete, - l-inibituri ta' l-enzima li tikkonverti anġjotensin (ACE) (użati għall-kura ta' ċerti kundizzjonijiet tal qalb jew ta' pressjoni għolja fid-demm) - disopyramide (użat għall-kura ta' ċerti kundizzjonijiet tal-qalb) - fluoxetine (użat għall-kura tad-depressjoni) - fibrates (użati biex ibaxxu l-livelli għoljin tal-lipidi fid-demm) - l-inibituri ta' monoamine oxidase (MAO) (użati għall-kura tad-depressjoni) - pentoxifylline, propoxyphene, salicylates (bħall-acetylsalicylic acid, użata biex ittaffi l-uġigħ u tbaxxi d-deni) - l-antibijotiċi sulfonamidi.
English: Unopened cartridges:
Maltese: Eżempji jinkludu:
English: Only use needles that are compatible for use with SoloStar (see “SoloStar Instructions for Use”).
Maltese: Uża biss labar li huma kompatibbli għall-użu ma' SoloStar (ara “Istruzzjonijiet għall-użu ta' SoloStar”).
English: It is unknown whether insulin glargine is excreted in human milk.
Maltese: Reazzjonijiet allerġiċi immedjati għall-insulina huma rari.
English: The use of Lantus may be considered during pregnancy, if clinically needed.
Maltese: L-użu ta' Lantus waqt it-tqala jista' jkun ikkunsidrat, jekk klinikament bżonnjuż.
English: Unopened vials
Maltese: Mhux komuni
English: Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms (see section 4.4).
Maltese: Ġeneralment dan il-fenomenu, u s-sintomi tiegħu, huma aktar żviluppati meta t-tnaqqis fil-livell taz-zokkor fid-demm ikun akbar u aktar mgħaġġel (ara sezzjoni 4.4).
English: Insulin glargine has a long and steady blood-sugar-lowering action.
Maltese: Neħħi s-siġill protettiv mil-labra l-ġdida.
English: Lantus 100 units/ml solution for injection in a vial 5 ml vial
Maltese: Lantus 100 unità/ml soluzzjoni għall-injezzjoni f'kunjett kunjett ta' 5 ml
English: Do not inject insulin.
Maltese: Tinjettax l-insulina.
English: SoloStar.
Maltese: Dożaġġ
English: Each cartridge or pen contains 3 ml of solution for injection, equivalent to 300 units.
Maltese: Kull skartoċċ jew pinna fiha 3 ml ta' soluzzjoni għall-injezzjoni, ekwivalenti għal 300 unità.
English: Consult your insulin pen instruction booklet for further details.
Maltese: Jekk jogħġbok ikkonsulta mattabib tiegħek għal aktar informazzjoni.
English: HYPERGLYCAEMIA (high blood sugar levels)
Maltese: IPOGLIĊEMIJA (livell baxx ta' zokkor fid-demm)
English: Management
Maltese: RESPONSABBLI
English: In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
Maltese: F'pazjenti li għandhom indeboliment fil-funzjoni tal-kliewi, il-ħtieġa għall-insulina tista' tonqos dovuta minħabba t-tnaqqis tal-metaboliżmu ta' l-insulina
English: In plasma, the principal circulating compound is the metabolite M1.
Maltese: Insulin glargine huwa mmetabolizzat f'żewġ metaboliti attivi
English: No metabolic effects of ingested insulin glargine on the breast-fed newborn/infant are anticipated since insulin glargine as a peptide is digested into aminoacids in the human gastrointestinal tract.
Maltese: Biex jiġu evitati żbalji fil-medikazzjoni bejn linsulina glargine u insulini oħra, it-tikketta ta' l-insulina għandha tiġi ċċekkjata qabel kull injezzjoni.
English: Solution for injection 1 vial of 10 ml
Maltese: Kunjett 1 ta' 10 ml.
English: INSTRUCTIONS ON USE
Maltese: Kunjetti mhux miftuħa
English: The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.
Maltese: Il-planġer jasal sat-tarf ta' l-iskartoċċ meta jintuża t-total ta' 300 unitajiet ta' insulina.
English: Secondary endpoints included all-cause mortality and a composite microvascular outcome.
Maltese: Riżultati finali sekondarji kienu jinkludu mewt minn kwalunkwe kawża u riżultat kompost mikrovaskulari.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: Time (h) after s.c. injection n)
English: There were no differences between insulin glargine and standard care for the two co-primary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome.
Maltese: Ma kien hemm ebda differenza bejn insulin glargine u l-kura standard għażżewġ lottijiet ta' riżultati primarji; għal kull komponent li jagħmel parti minn dawn ir-riżultati; għall-mewt minn kwalunkwe kawża; jew għar-riżultat compost mikrovaskulari.
English: In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Maltese: Fl-anzjani, id-deterjorament b'mod progressiv fil-funzjoni tal-kliewi tista' twassal għal tnaqqis b'mod kostanti fil-ħtiġijiet tal-insulina.
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Il-kriterju ewlieni tal-effikaċja kien jew mewta kardjovaskulari, rikoveru l-isptar għal MI akuta jew rikoveru l-isptar għall-feġġa ġdida jew aggravar ta' insuffiċjenza tal qalb.
English: June 2018
Maltese: Ġunju 2018
English: Absorption and bioavailability
Maltese: Assorbiment u bijodisponibilità
English: Istituto Farmaco Biologico Stroder S.r.l.
Maltese: Italia Istituto Farmaco Biologico Stroder S.r.l.
English: Hazard ratio [95% CI]
Maltese: Proporzjon ta' periklu [95% CI]
English: AV 1st degree block (ECG prolonged PQ interval)
Maltese: Imblokk AV 1 grad (ECG prolongat fl-interval PQ)
English: Placebo (N=3264) n (%)
Maltese: (N=3264) n (%)
English: Environmental Risk Assessment (ERA)
Maltese: Rapport ta' Stima tar-Riskju Ambjentali (ERA)
English: Hypromellose (E 464) Titanium dioxide (E171) Macrogol 6000
Maltese: Titanium dioxide (E171) Macrogol 6000
English: Annopol 6B - 03-236 Warszawa - Poland and
Maltese: Annopol 6B - 03-236 Warszawa - Il-Polonja u
English: Arklow - Co. Wicklow - Ireland
Maltese: Wicklow - L-Irlanda
English: The absolute risk reduction was 4.2%.
Maltese: It-tnaqqis assolut fir-riskju kien ta' 4.2%.
English: (see section 5.1)
Maltese: (ara sezzjoni 5.1).
English: Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy - France
Maltese: Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy - Franza
English: Marketing Authorisation Holder: Les Laboratoires Servier 50, rue Carnot
Maltese: Les Laboratoires Servier 50, rue Carnot
English: Date of latest renewal: 25/10/2010
Maltese: Data tal-aħħar tiġdid: 25/10/2010
English: Cytochrome P450 3A4 (CYP3A4)
Maltese: Iċ-ċitokromu P4503A4 (CYP3A4)
English: System Organ Class
Maltese: Sistema ta' klassifika tal-organi
English: de los Madroños, 33 28043 Madrid Spain
Maltese: Laboratorios Servier, S.L. Avda. de los Madroños, 33 28043 Madrid Spanja
English: INFORMATION IN BRAILLE CORLENTOR 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE CORLENTOR 5 mg
English: Ivabradine has been studied in clinical trials involving nearly 45,000 participants.
Maltese: Ivabradine ġie studjat fi provi kliniċi li involvew 45,000 partiċipant.
English: Ivabradine influences on retinal function (see section 5.1).
Maltese: Ivabradine jinfluwenza l-funzjoni retinali (ara sezzjoni 5.1).
English: Pharmacokinetic/pharmacodynamic (PK/PD) relationship
Maltese: Ir-relazzjoni farmakokinetika/farmakodinamika (PK/PD)
English: INFORMATION IN BRAILLE CORLENTOR 7.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE CORLENTOR 7.5 mg
English: Diplopia Visual impairment
Maltese: Diplopja Indeboliment fil-vista
English: Österreich Servier Austria GmbH Tel: +43 (1) 524 39 99
Maltese: Servier Austria GmbH Tel: +43 (1) 524 39 99
English: Bradycardia
Maltese: bradikardija
English: 92284 Suresnes cedex - France
Maltese: Suresnes cedex - Franza
English: Symptomatic treatment of chronic stable angina pectoris
Maltese: Kura sintomatika ta' anġina pectoris kronika stabbli
English: Calendar packs containing 14, 28, 56, 84, 98, 100 or 112 film-coated tablets.
Maltese: Pakketti bil-ġranet li fihom 14, 28, 56, 84, 98, 100 jew 112 pilloli miksija b'rita.
English: Ivabradine is the S-enantiomer with no bioconversion demonstrated in vivo.
Maltese: Ivabradine huwa S-enantiomer u ma wera l-ebda biokonverżjoni in vivo.
English: Annopol 6B - 03-236 Warszawa, Poland Laboratorios Servier, S.L, Avda.
Maltese: Annopol 6B - 03-236 Warszawa, Il-Polonja Laboratorios Servier, S.L, Avda. de los Madroños, 33 -28043 Madrid, Spanja
English: Atrial fibrillation - Cardiac arrhythmias
Maltese: Fibrillazzjoni ta' l-atriju - Aritmija kardijaka
English: QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol,
Maltese: Mediċini li jtawwlu l-QT - Mediċini kardjovaskulari li jtawwlu l-QT (eż. quinidine, disopyramide, bepridil, sotalol, ibutilide,
English: Other medicines and Corlentor
Maltese: Mediċini oħra u Corlentor
English: The median follow-up duration was 22.9 months.
Maltese: Il-perjodu ta' segwitu medjan kien 22.9 xhur.
English: 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.
Maltese: Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, Franza Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co.
English: The tablets are available in calendar packs (Aluminium/PVC blisters) of 14, 28, 56, 84, 98, 100 or 112 tablets.
Maltese: Il-pilloli jiġu f'pakketti (folji tal-Aluminju/PVC) ta' 14, 28, 56, 84, 98, 100 jew 112-il pillola immarkati bil-ġranet.
English: Tel: +421 0(2) 5920 41 11
Maltese: s r.o. Tel: +421 0(2) 5920 41 11
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).
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrapporatati waqt provi kliniċi u huma kklassifikati bl-użu ta' din ilfrekwenza: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1000 sa <1/100); rari (≥1/10000 sa <1/1000); rari ħafna (<1/10000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: There was a significant improvement in NYHA class at last recorded value, 887 (28%) of patients on ivabradine improved versus 776 (24%) of patients on placebo (p=0.001).
Maltese: Kien hemm titjib sinifikanti fil-klassi tan-NYHA fl-aħħar valur irreġistrat, 887 (28%) tal-pazjenti fuq ivabradine tjiebu kontra 776 (24%) tal-pazjenti li ħadu plaċebo (p=0.001).
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 miksija 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 4.3).
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).
Maltese: Corlentor 7.5 mg: pillola waħda miksija b'rita fiha 7.5 mg ivabradine (ekwivalenti għal 8.085 mg ivabradine hydrochloride) - Is-sustanzi l-oħra fil-qalba tal-pillola huma: lactose monohydrate, magnesium stearate (E 470 B), maize starch, maltodextrin, colloidal anhydrous silica (E 551), u fil-kisja tal-pillola: hypromellose (E 470), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470B), iron oxide isfar (E 172), iron oxide aħmar (E 172).
English: Ventricular extrasystoles Atrial fibrillation
Maltese: Żieda fl-extra sistoli ventrikulari Fibrillazzjoni atrijali
English: Glycerol (E 422) Magnesium stearate (E 470 B) Yellow iron oxide (E172) Red iron oxide (E172)
Maltese: Glycerol (E 422) Magnesium stearate (E 470 B)
English: The effects on blood pressure and peripheral vascular resistance were minor and not clinically significant.
Maltese: effetti fuq il-pressjoni u fuq resistenza periferali vaskulari kienu minimi u klinikament mhux sinifikanti.
English: Pack sizes
Maltese: Viżta mċajpra
English: About stable angina pectoris (usually referred to as “angina”):
Maltese: X'inhi angina pectoris stabbli (magħrufa normalment bħala “anġina”)
English: Hyperuricaemia
Maltese: Iperuricemia
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).
Maltese: Ġiet osservata żieda statistikament sinifikanti żgħira fil-PCE f'sottogrupp ta' pazjenti speċifikat minn qabel b'anġina fil-klassi CCS II jew ogħla fil-linja bażi (n=12,049) (rati annwali 3.4% meta mqabbel ma' 2.9%, riskju relattiv ta' ivabradine/plaċebo 1.18, p=0.018), iżda mhux fis-sottogrupp tal-popolazzjoni globali tal-anġina fil-klassi CCS ≥ I (n=14,286) (riskju relattiv ta' ivabradine/plaċebo 1.11, p=0.110).
English: and 45%), ivabradine did not have any deleterious influence on LVEF.
Maltese: bejn 30 u 45%), ivabradine ma kellu ebda influwenza ta' ħsara fuq LVEF.
English: In patients treated with ivabradine the risk of developing atrial fibrillation is increased (see section 4.8).
Maltese: F'pazjenti kkurati b'ivabradine, hemm riskju akbar li tiġi żviluppata fibrillazzjoni atrijali (ara sezzjoni 4.8).
English: Excipient with known effect: 61.215 mg lactose monohydrate For the full list of excipients, see section 6.1.
Maltese: Eċċipjent b'effett magħruf: 61.21 mg lactose monohydrate Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: AV 2nd degree block, AV 3rd degree block Sick sinus syndrome
Maltese: Imblokk AV tat-2ni grad, imblokk AV tat-3et grad
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 half-life effettiva ta' 11-il siegħa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/317/008-014
Maltese: EU/1/05/317/008-014
English: Palpitations, supraventricular extrasystoles
Maltese: Palpitazzjonijiet, żieda fl-extra sistoli supra ventrikulari
English: Erythema Pruritus Urticaria
Maltese: Eritema Prurite Urtikarja
English: Aluminium/PVC blister packed in cardboard boxes.
Maltese: Folji ta' Aluminium/PVC ippakkjati f'kaxxi tal-kartun.
English: - CYP3A4 inducers: CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin, Hypericum perforatum [St John's Wort]) may decrease ivabradine exposure and activity.
Maltese: rifampicin, barbiturates, phenytoin, Hypericum perforatum [St. John's Wort] jistgħu jnaqqsu l esponiment u l-attività ta' ivabradine.
English: ibutilide, amiodarone).
Maltese: amiodarone).
English: Excipient with known effect: 63.91 mg lactose monohydrate For the full list of excipients, see section 6.1.
Maltese: Eċċipjent b'effett magħruf: 63.91 mg lactose monohydrate Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Patients received standard care including beta-blockers (89 %), ACE inhibitors and/or angiotensin II antagonists (91 %), diuretics (83 %), and anti-aldosterone agents (60 %).
Maltese: u/jew antagonisti ta' angiotensin II (91 %), dijuretiċi (83 %), u sustanzi kontra l-aldosterone (60 %).
English: Ivabradine is extensively metabolised by the liver and the gut by oxidation through cytochrome P450 3A4 (CYP3A4) only.
Maltese: Ivabradine jiġi metabolizzat b'mod estensiv mill-fwied u mill-istonku permezz ta' ossidazzjoni biċċitokromu P450 3A4 (CYP3A4) biss.
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).
Maltese: Analiżi ta' tnaqqis fir-rata tat-taħbit tal-qalb 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: 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.
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-blockers.
English: Corlentor may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Maltese: Corlentor jista' jikkaġunalek fenomeni viżivi mudwali temporanji (luminożità temporanja fil-kamp viżiv, ara “Effetti Sekondarji li jista' jkollu”).
English: Primary composite endpoint Components of the composite: - CV death - Hospitalisation for worsening HF
Maltese: Endpoint kompost primarju Komponenti tal-kompost: - mewt kardjovaskulari
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: Użu flimkien ieħor 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 il-farmokokinetika u lfarmakodinamika ta' ivabradine: impedituri proton pump (omeprazole, lansoprazole), sildenafil, impedituri HMG COA reductase (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin u warfarin.
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: These trials included a total of 4,111 patients with chronic stable angina pectoris, of whom 2,617 received ivabradine.
Maltese: F'dawn ilprovi ħadu sehem 4111 pazjent b'angina pectoris kronika stabbli, li minnhom 2617 ħadu ivabradine.
English: The difference in heart rate between ivabradine and placebo arms was 10.8 bpm at 28 days, 9.1 bpm at 12 months and 8.3 bpm at 24 months.
Maltese: 8 bpm wara 28 jum, 9.1 bpm wara 12-il xahar u 8.3 bpm wara 24 xahar.
English: - Renal impairment: 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
Maltese: - Indeboliment renali: l-impatt ta' indeboliment renali (tneħħija tal-krejatinina minn 15 sa 60 mL/min) fuq il-farmakokinetika 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: 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.
Maltese: III tal-provi kliniċi, il-prodotti mediċinali msemmija hawn taħt ingħataw bħas-soltu flimkien ma' ivabradine mingħajr l-ebda evidenza ta' biża fuq is-sigurtà: impedituri angiotensin converting enżemi, antagonisti angiotensin II, imblokkaturi tar-riċetturi beta, dijuretiċi, sustanzi kontra l aldosterone agents, nitrates li jaħdmu fil-qosor u fit-tul, impedituri HMG CoA reductase, fibrates,
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: LOT
Maltese: LOTT
English: The maximum plasma concentration following chronic administration at the recommended dose of 5 mg twice daily is 22 ng/ml (CV=29%).
Maltese: L-ogħla konċentrazzjoni fil-plażma meta jingħata fit-tul f'doża rakkomandata ta' 5 mg darbtejn kuljum hija ta' 22 ng/mL (CV = 29%).
English: MON TUE WED THU FRI SAT SUN
Maltese: M'għandekx tgħaddiha lil persuni oħra.
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: II/III b'durata ta' mill-inqas 3 xhur li jinkludu aktar minn 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: The metabolism of this active metabolite also involves CYP3A4.
Maltese: din is-sustanza attiva ffurmata fil-metaboliżmu wkoll tinvolvi CYP3A4.
English: The potent CYP3A4 inhibitors ketoconazole (200 mg once daily) and josamycin (1 g twice daily) increased ivabradine mean plasma exposure by 7 to 8 fold.
Maltese: Limpedituri qawwija ta' CYP3A4 ketoconazole (200 mg darba kuljum) u josamycin (1g darbtejn kuljum)
English: Angioedema Rash
Maltese: Mhux komuni* Anġjoedema Raxx
English: Do not take Corlentor if you are breast-feeding (see “Do not take Corlentor”).
Maltese: Tiħux Corlentor jekk qed tredda' (ara taħt “Tiħux Corlentor”).
English: Preferred Term
Maltese: Frekwenza Terminu ppreferut
English: ECG prolonged QT interval * Frequency calculated from clinical trials for adverse events detected from spontaneous report
Maltese: * Il-frekwenza hija kkalkolata minn provi kliniċi għal avvenimenti avversi mikxufin minn rapport spontanju
English: In the subgroup of patients with HR ≥ 75 bpm (n=4150), 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 fl-endpoint 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.