FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk for increased exposure leading to adverse events in these different subgroups is higher in patients lacking CYP2D6 activity (poor metabolisers, PM) than subjects with CYP2D6 metabolising capacity (extensive metabolisers, EM) (see section 5.2).
Maltese: Ir-riskju ta' żieda fl-esponiment li twassal għal avvenimenti avversi f'dawn is-sottogruppi differenti hija aktar għolja f'pazjenti b'nuqqas ta' attività ta' CYP2D6 (metabolizzaturi dgħajfin, PM) milli f'suġġetti b'kapaċità metabolizzanti ta' CYP2D6 (metabolizzaturi estensivi, EM) (ara sezzjoni 5.2).
English: These were reported during the Phase 3 clinical development programme, which included a total of 1,030 chronic angina patients treated with Ranexa.
Maltese: Dawn kienu rrapportati waqt program ta' żvilupp kliniku Fażi 3, li nkludew total ta' 1,030 pazjent b'anġina kronika kkurati b'Ranexa.
English: - if you are using certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazol, posaconazol), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).
Maltese: Tużax il-mediċini li ġejjin jekk tieħu Ranexa: - ċerti mediċini biex tikkura infezzjonijiet batteriċi (clarithromycin, telithromycin), infezzjonijiet fungali (itraconazole, ketoconazole, voriconazol, posaconazol), infezzjoni HIV (impedituri protease), depressjoni (nefazodone) jew disturbi tar-ritmu tal-qalb (eż. quinidine, dofetilide, jew sotalol).
English: Concomitant administration of potent CYP3A4 inhibitors is contraindicated (see sections 4.3 and 4.5).
Maltese: Għoti ta' impedituri CYP3A4 qawwija flimkien mhuwiex rakkomandat (ara sezzjonijiet 4.3 u 4.5).
English: Of the most commonly reported, the following events occurred more often with Ranexa (placebo-corrected frequencies) in elderly (≥ 75 years of age) than younger patients (< 75 years of age): constipation (8% versus 5%), nausea (6% versus 3%), hypotension (5% versus 1%), and vomiting (4% versus 1%).
Maltese: Fost l-aktar avvenimenti komuni rapportati, l-avvenimenti li ġejjin seħħew aktar ta' spiss b'Ranexa (frekwenzi korretti bi plaċebo) fl-anzjani (età ≥ 75-il sena) milli f'pazjenti aktar żgħar (età < 75-il sena): stitikezza (8% kontra 5%), dardir (6% kontra 3%), pressjoni tad-demm baxxa (5% kontra 1%), u remettar (4% kontra 1%).
English: Atorvastatin: Ranexa 1000 mg twice daily increased Cmax and AUC of atorvastatin 80 mg once daily by 1.4- and 1.3 -fold, respectively and changed the Cmax and AUC of atorvastatin metabolites less than 35%.
Maltese: Ranexa 1000 mg darbtejn kuljum żied is-Cmax u AUC ta' atorvastatin 80 mg darba kuljum b'1.4- u 1.3-il darba, rispettivament u bidel is-Cmax u l-AUC tal-metaboli ta' atorvastatin b'anqas minn 35%. Limitazzjoni tad-doża ta' atorvastatin u monitoraġġ kliniku xieraq jistgħu ikunu meqjusa meta jkun qed jittieħed Ranexa.
English: Body weight: Compared to subjects weighing 70 kg, exposure was estimated to be about 1.4-fold higher in subjects weighing 40 kg.
Maltese: Meta mqabbel ma' suġġetti li jiżnu 70 kg, l-esponiment kien stmat li huwa madwar 1.4-il darba aktar għoli f'suġġetti li jiżnu 40 kg.
English: QT prolongation: Ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner.
Maltese: Titwil QT: Ranolazine jimblokka IKr u jtawwal l-intervall QTc b'mod marbut mad-doża.
English: EU/1/08/462/003 60 tablets in blister pack EU/1/08/462/004 60 tablets in bottle EU/1/08/462/009 30 tablets in blister pack EU/1/08/462/010 100 tablets in blister pack
Maltese: EU/1/08/462/003 60 pillola f'pakkett ta' folji EU/1/08/462/004 60 pillola fi fliexkun EU/1/08/462/009 30 pillola f'pakkett ta' folji EU/1/08/462/010 100 pillola f'pakkett ta' folji
English: Given the dose-dependent side effects and similar efficacy at 750 and 1000 mg twice daily, a maximum dose of 750 mg twice daily is recommended.
Maltese: Minħabba l-effetti sekondarji dipendenti fuq id-doża u effikaċja simili f'750 u 1000 mg darbtejn kuljum, hija rrakkomandata doża massima ta' 750 mg darbtejn kuljum.
English: Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.
Maltese: Menarini Distribution Ljubljana d.o.o.
English: EU/1/08/462/005 60 tablets in blister pack EU/1/08/462/006 60 tablets in bottle EU/1/08/462/011 30 tablets in blister pack EU/1/08/462/012 100 tablets in blister pack
Maltese: EU/1/08/462/005 60 pillola f'pakkett ta' folji EU/1/08/462/006 60 pillola fi fliexkun EU/1/08/462/011 30 pillola f'pakkett ta' folji EU/1/08/462/012 100 pillola f'pakkett ta' folji
English: Combining ranolazine with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) is contraindicated (see section 4.3).
Maltese: Mhuwiex rakkomandat li l-impedituri CYP3A4 qawwija (eż. itraconazole, ketoconazole, voriconazole, posaconazole, impedituri HIV protease, clarithromycin, telithromycin, nefazodone) jittieħdu flimkien ma' ranolazine (ara sezzjoni 4.3).
English: The safety and efficacy of Ranexa in children below the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Ranexa fit-tfal taħt l-età ta' 18-il sena ma ġewx determinati.
English: EU/1/08/462/001 60 tablets in blister pack EU/1/08/462/002 60 tablets in bottle EU/1/08/462/007 30 tablets in blister pack EU/1/08/462/008 100 tablets in blister pack
Maltese: EU/1/08/462/001 60 pillola f'pakkett ta' folji EU/1/08/462/002 60 pillola fi fliexkun EU/1/08/462/007 30 pillola f'pakkett ta' folji EU/1/08/462/008 100 pillola f'pakkett ta' folji
English: Headache
Maltese: parożmja.
English: Ranexa is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3 and 5.2).
Maltese: Ranexa mhijiex rakkomandata f'pazjenti b'indeboliment severi tal-kliewi (tneħħija tal-kreatinina < 30 ml/min) (ara sezzjonijiet 4.3 u 5.2).
English: Renal impairment: In a study evaluating the influence of renal function on ranolazine pharmacokinetics, ranolazine AUC was on average 1.7- to 2-fold higher in subjects with mild, moderate, and severe renal impairment compared with subjects with normal renal function.
Maltese: Fi studju li evalwa l-influwenza tal-funzjoni tal-kliewi fuq farmakokinetiċi ta' ranolazine, l-AUC ta' ranolazine kienet bħala medja 1.7 sa 2 drabi ogħla f'suġġetti b'indeboliment tal-kliewi ħafif, moderat, u sever, meta mqabblin ma' suġġetti b'funzjoni tal-kliewi normali.
English: In the main dose-finding study, MARISA, ranolazine was used as monotherapy.
Maltese: Fl-istudju ewlieni ta' sejbien tad-doża, MARISA, ranolazine intuża bħala monoterapija.
English: Ranexa 750 mg prolonged-release tablets contain lactose monohydrate.
Maltese: Il-pilloli ta' Ranexa 750 mg li jerħu l-mediċina bil-mod fihom lactose monohydrate.
English: In healthy young adults, ranolazine accounts for approximately 13% of the radioactivity in plasma following a single oral 500 mg dose of [
Maltese: F'adulti żgħar f'saħħithom, ranolazine jagħti spjegazzjoni għal madwar 13% tar-radjuattività fil-plażma wara doża waħda orali ta' 500 mg ta' [
English: Ranexa is supplied in cartons containing 30, 60, or 100 tablets in blister strips or 60 tablets in plastic bottles.
Maltese: Ranexa hija fornuta f'pakketti li fihom 30, 60, jew 100 pillola fi folji jew 60 pillola fi fliexken tal-plastik.
English: There was a 2.5- to 3-fold increase in steady-state AUC as the dose was increased from 500 mg to 1000 mg twice daily.
Maltese: Kien hemm żieda ta' 2.5 sa 3 darbiet f'AUC ta' stat fiss hekk kif id-doża żdiedet minn 500 mg għal 1000 mg darbtejn kuljum.
English: Uncommon: dyspnoea, cough, epistaxis.
Maltese: Mhux komuni: disurja, ematurja, kromaturja.
English: There is a lower need for precautions in patients with CYP2D6 EM status.
Maltese: Hemm ħtieġa aktar baxxa għal prekawzjoniet f'pazjenti bi status CYP2D6 EM.
English: Ranexa may cause dizziness, blurred vision, diplopia, confusional state, coordination abnormal, hallucination (see section 4.8), which may affect the ability to drive and use machines.
Maltese: Ranexa tista' tikkaġuna sturdament, vista mċajjpra, diplopja, stat konfużjonali, koordinazzjoni anormali u alluċinazzjoni (ara sezzjoni 4.8), li tista' taffettwa l-ħila biex issuq u tħaddem magni.
English: The potent CYP2D6 inhibitor paroxetine, at a dose of 20 mg once daily, increased steady-state plasma concentrations of ranolazine 1000 mg twice daily by an average of 1.2-fold.
Maltese: Paroxetine, l-impeditur qawwi CYP2D6, f'doża ta' 20 mg darba kuljum, żied il-konċentrazzjonijiet ta' stat fiss ta' 1000 mg ranolazine darbtejn kuljum fil-plażma b'medja ta' 1.2-il darba.
English: The exposure of other OCT2 substrates, including but not limited to pindolol and varenicline, may be affected to a similar degree.
Maltese: L-esponiment ta' sottostrati OCT2 oħra, inklużi iżda mhux biss pindolol u varenicline, jistgħu jkunu effettwati fi grad simili.
English: Ranexa 1000 mg twice daily increased plasma concentrations of simvastatin lactone, simvastatin acidby about 2-fold.
Maltese: Ranexa 1000 mg darbtejn kuljum żiedet il-konċentrazzjonijiet ta' simvastatin lactone fil-plażma, aċidu simvastatin b'madwar id-doppju.
English: In vitro studies using human liver microsomes indicate that ranolazine is metabolised primarily by CYP3A4, but also by CYP2D6.
Maltese: Studji in vitro permezz ta' l-użu ta' mikrożomi tal-fwied tal-bniedem jindikaw li ranolazine huwa metabolizzat primarjament minn CYP3A4, u wkoll minn CYP2D6.
English: In this study, there was a higher reporting rate for congestive heart failure in the ranolazine group (2.2% vs 1.0% in placebo).
Maltese: F'dan l-istudju kien hemm rata ogħla ta' rappurtar ta' insuffiċjenza konġestiva tal-qalb fil-grupp ta' ranolazine (2.2% vs 1.0% fil-plaċebo).
English: An increased incidence of adverse events was seen among ranolazine treated patients in the RIVERPCI trial (see section 5.1) where patients with incomplete revascularization post-PCI were given ranolazine up to 1000 mg twice daily or placebo for approximately 70 weeks.
Maltese: Żieda fl-inċidenza ta' avvenimenti avversi dehret fost pazjenti ttrattati b'ranolazine fil-prova RIVERPCI (ara sezzjoni 5.1) fejn pazjenti b'rivaskularizzazzjoni mhux kompluta wara PCI ingħataw ranolazine sa 1,000 mg darbtejn kuljum jew plaċebo għal madwar 70 ġimgħa.
English: Improvement of exercise duration was statistically significant compared to placebo for all three doses of ranolazine from 24 seconds at 500 mg twice daily to 46 seconds at 1500 mg twice daily, showing a dose-related response.
Maltese: It-titjib f'kemm idum l-eżerċizzju kien statistikament sinjifikanti meta mqabbel ma' plaċebo għat-tliet dożi l-oħrajn kollha ta' ranolazine minn 24 sekonda b'500 mg darbtejn kuljum għal 46 sekonda b'1500 mg darbtejn kuljum, u dan juri rispons relatat mad-doża.
English: After oral administration of Ranexa, peak plasma concentrations (Cmax) are typically observed between 2 and 6 hours.
Maltese: Wara għoti orali ta' Ranexa, konċentrazzjonijiet massimi fil-plażma (Cmax) huma tipikament osservati bejn 2 sa 6 sigħat.
English: One-hundred and ninety-one patients were randomised to treatment with Ranexa 500 mg twice daily, 1000 mg twice daily, 1500 mg twice daily, and matching placebo, each for 1 week in a crossover design.
Maltese: Mija u wieħed u disgħin pazjent kienu rrandomizzati għal kura b'Ranexa 500 mg darbtejn kuljum, 1000 mg darbtejn kuljum, 1500 mg darbtejn kuljum, u plaċebo li jaqbel, kollha għal ġimgħa f'disinn crossover.
English: Common side effects (occur in 1 to 10 users in 100) are: Constipation
Maltese: Effetti sekondarji komuni (iseħħu f'1 sa 10 pazjenti minn kull 100) huma:
English: Dose adjustment of sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin) and CYP3A4 substrates with a narrow therapeutic range (e.g. ciclosporin, tacrolimus, sirolimus, everolimus) may be required as RANEXA may increase plasma concentrations of these drugs.
Maltese: Aġġustamenti tad-doża ta' sottostrati sensittivi għal CYP3A4 (eż simvastatin, lovastatin) u sottostrati ta' CYP3A4 b'medda terapewtika dejqa (eż, cyclosporin, tacrolimus, sirolimus, everolimus) jistgħu jkunu meħtieġa minħabba li RANEXA tista' tgħolli l-konċentrazzjonijiet fil-plażma ta' dawn ilmediċini.
English: Adverse reactions not observed in clinical studies, but seen in animals at levels similar to clinical exposure, were as follows: Ranolazine was associated with convulsions and increased mortality in rats and dogs at plasma concentrations approximately 3-fold higher than at the proposed maximum clinical dose.
Maltese: Reazzjonijiet avversi mhux osservati fi studji kliniċi, iżda dehru f'annimali f'livelli simili għal esponiment kliniku kienu kif ġejjin, Ranolazine kien assoċjat ma' aċċessjonijiet u żieda fil-mortalità fil-firien u fil-klieb f'konċentrazzjonijiet fil-plażma madwar 3 drabi aktar għoljin milli fid-doża klinika massima proposta.
English: Metabolism and nutrition disorders Uncommon: anorexia, decreased appetite, dehydration.
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni: anoressja, tnaqqis fl-aptit, deidratazzjoni Rari: iponatrimja
English: Eight-hundred and twenty-three patients (23% women) were randomised to receive 12 weeks of treatment with Ranexa 750 mg twice daily, 1000 mg twice daily, or placebo.
Maltese: Tmien mija u tlieta u għoxrin pazjent (23% nisa) kienu randomizzati li jirċievu 12-il ġimgħa ta' kura b'Ranexa 750 mg darbtejn kuljum, 1000 mg darbtejn kuljum, jew plaċebo.
English: Additional excipients for 750 mg tablet:
Maltese: Sustanzi mhux attivi addizzjonali għall-pilloli ta' 750 mg:
English: Less than 5% of the dose is excreted unchanged in the urine and faeces.
Maltese: Inqas minn 5% tad-doża hija eliminata mhux mibdula fl-awrina u l-ippurgar.
English: A population-based analysis of combined data from patients and healthy volunteers demonstrated that the slope of the plasma concentration-QTc relationship was estimated to be 2.4 msec per 1000 ng/ml, which is approximately equal to a 2- to 7-msec increase over the plasma concentration range for ranolazine 500 to 1000 mg twice daily.
Maltese: Analiżi bbażata fuq il-popolazzjoni ta' dejta kkumbinata minn pazjenti u voluntiera f'saħħithom uriet li l-inżul tar-relazzjoni tal-konċentrazzjoni tal-plażma-QTc kienet stmata li hija 2.4 msek kull 1000 ng/ml, li hija bejn wieħed u ieħor daqs żieda ta' 2- sa 7-msek fuq il-medda ta' konċentrazzjoni fil-plażma għal ranolazine 500 sa 1000 mg darbtejn kuljum.
English: Ranexa 750 mg prolonged-release tablets contain the azo colouring agent E102.
Maltese: Il-pilloli ta' Ranexa 750 mg li jerħu l-mediċina bil-mod fihom is-sustanza ta' kulur azo E102.
English: Laboratory findings: Small, clinically insignificant, reversible elevations in serum creatinine levels have been observed in healthy subjects and patients treated with Ranexa.
Maltese: Elevazzjonijiet żgħar, klinikament insinifikanti, riversibbli f'livelli ta' kreatinina fis-serum kienu osservati f'suġġetti f'saħħithom u pazjenti kkurati b'Ranexa.
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 dwar il-Mediċini http://www.ema.europa.eu/.
English: Ranexa is contraindicated in patients with moderate or severe hepatic impairment (see sections 4.3 and 5.2).
Maltese: Ranexa mhijiex rakkomandata f'pazjenti b'indeboliment tal-fwied moderat jew severi (ara sezzjonijiet 4.3 u 5.2).
English: Ranexa resulted in significant decreases in the number of angina attacks per week (p = 0.028) and consumption of short-acting nitroglycerin (p = 0.014) compared to placebo.
Maltese: Ranexa rriżultat fi tnaqqis sinifikanti fin-numri ta' attakki ta' l-anġina kull ġimgħa (p = 0.028) u l-konsum ta' nitrogliċerina (p = 0.014) li taħdem għal qasir żmien meta mqabbla ma' plaċebo.
English: Using other medicines and Ranexa
Maltese: Meta tieħu mediċini oħra ma' Ranexa
English: Blister pack: 5 years Bottle pack: 4 years
Maltese: Pakkett tal-flixkun: 4 snin
English: In general, the type and frequency of adverse events reported in patients with low body weight (≤ 60 kg) were similar to those of patients with higher weight (> 60 kg); however, the placebocorrected frequencies of the following common adverse events were higher in low body weight than heavier patients: nausea (14% versus 2%), vomiting (6% versus 1%), and hypotension (4% versus
Maltese: B'mod ġenerali, it-tip u l-frekwenza ta' avvenimenti avversi rrapportati f'pazjenti b'piż korporali baxx (≤ 60 kg) kienu simili għal dawk ta' pazjenti b'piż korporali aktar għoli (> 60 kg); madankollu, il-frekwenzi korretti bi plaċebo ta' l-avvenimenti avversi komuni li ġejjin kienu aktar għoljin f'pazjenti b'piż korporali baxx milli f'pazjenti aktar tqal: dardir (14% kontra 2%), remettar (6% kontra 1%), u pressjoni tad-demm baxxa (4% kontra 2%).
English: Light orange oval-shaped tablet engraved with 500 on one side.
Maltese: Pillola b'forma ovali oranġjo ċar imnaqqxa b' 500 fuq naħa waħda.
English: The mean steady-state volume of distribution (Vss) is about 180 l.
Maltese: Il-volum ta' distribuzzjoni ta' stat fiss (Vss) medju huwa madwar 180 l.
English: Careful dose titration of Ranexa is recommended in patients treated with diltiazem and other moderately potent CYP3A4 inhibitors (e.g. erythromycin, fluconazole).
Maltese: Titrazzjoni bir-reqqa tad-doża ta' Ranexa hija rrakkomandata f'pazjenti kkurati b'diltiazem jew impedituri CYP3A4 oħra moderatament qawwija (eż. erythromycin, fluconazole).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 375 mg ranolazine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola li terħi l-mediċina bil-mod fiha 375 mg ranolazine.
English: If you cannot contact your doctor, go to the nearest accident and emergency department.
Maltese: Jekk ma tistax taqbad lit-tabib tiegħek, mur fl-eqreb dipartiment ta' l-emerġenza.
English: However, there was no difference in exercise duration between the two doses (24 seconds compared to placebo; p ≤ 0.03).
Maltese: Madankollu, ma kien hemm l-ebda differenza fit-tul ta' żmien ta' l-eżerċizzju bejn iżżewġ dożi (24 sekonda meta mqabbla ma' plaċebo; p ≤ 0.03).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 500 mg ranolazine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola li terħi l-mediċina bil-mod fiha 500 mg ranolazine.
English: Effects of ranolazine on other medicinal products
Maltese: Effetti ta' ranolazine fuq prodotti mediċinali oħra
English: Renal impairment: Careful dose titration is recommended in patients with mild to moderate renal impairment (creatinine clearance 30-80 ml/min) (see sections 4.4, 4.8, and 5.2).
Maltese: Indeboliment tal-kliewi: Titrazzjoni tad-doża bir-reqqa hija rrakkomandata f'pazjenti b'indeboliment tal-kliewi ħafif għal moderat (tneħħija tal-kreatinina 30-80 ml/min) (ara sezzjonijiet 4.4, 4.8, u 5.2).
English: The 375 mg tablets are pale blue and are engraved with 375 on one side.
Maltese: GĦAMLA FARMAĊEWTIKA Pillola li terħi l-mediċina bil-mod Pillola ċelesti ovali mnaqqxa b' 375 fuq naħa waħda.
English: Uncommon: lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness, paresthesia.
Maltese: Mhux komuni: letarġija, ħass ħażin, ipoestiżja, ngħas, rogħda, sturdament posturali, paraesteżija.
English: A population analysis of combined data from 1,308 patients and healthy volunteers demonstrated a mean increase in QTc from baseline of 2.4 msec per 1000 ng/ml ranolazine plasma concentration.
Maltese: Analiżi tal-popolazzjoni ta' dejta kkumbinata minn 1,308-il pazjent u voluntiera f'saħħithom urew żieda medja fil-QTc mil-linja bażi b'2.4 msek kull 1000 ng/ml konċentrazzjoni ta' ranolazine fil-plażma.
English: NAME OF THE MEDICINAL PRODUCT Ranexa 500 mg prolonged-release tablets Ranolazine
Maltese: Ranexa 500 mg pilloli li jerħu l-mediċina bil-mod Ranolazine
English: NAME OF THE MEDICINAL PRODUCT Ranexa 750 mg prolonged-release tablets Ranolazine
Maltese: Ranexa 750 mg pilloli li jerħu l-mediċina bil-mod Ranolazine
English: NAME OF THE MEDICINAL PRODUCT Ranexa 375 mg prolonged-release tablets Ranolazine
Maltese: Ranexa 375 mg pilloli li jerħu l-mediċina bil-mod Ranolazine
English: Ranexa is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).
Maltese: Ranexa hija indikata bħala terapija add-on fl-adulti għall-kura sintomatika ta' pazjenti b'anġina pectoris stabbli li mhumiex ikkontrollati adegwatament jew mhumiex tolleranti għal terapiji ta' l-ewwel għażla kontra l-anġina (bħalma huma mblokkaturi-beta u/jew antagonisti tal-kalċju).
English: Initiation of treatment with Ranexa should be avoided during administration of inducers of CYP3A4 (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort) (see section 4.4).
Maltese: Ranexa m'għandhiex tintuża f'pazjenti kkurati b'indutturi CYP3A4 (eż. rifampicin, phenytoin, phenobarbital, carbamazepine, St.
English: Additionally, 45% of the study population also received long-acting nitrates.
Maltese: Barra minn hekk, 45% mill-popolazzjoni ta' l-istudju rċiviet ukoll nitrati li jaħdmu fit-tul.
English: - medicines to treat epilepsy or another neurologic disorder (e.g. phenytoin, carbamazepine, or phenobarbital); are taking rifampicin for an infection (e.g. tuberculosis); or are taking the herbal remedy St. John's Wort, as these medicines may cause Ranexa to be less effective.
Maltese: - mediċini biex tikkura epilessija jew disturb newroloġiku ieħor (eż. phenytoin, carbamazepine, jew phenobarbital); jekk qiegħed tieħu rifampicin għall-infezzjoni (eż. tuberculosis); jew jekk qiegħed tieħu r-rimedju erbali St.
English: - if you are elderly.
Maltese: Adulti:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Menarini International O. L. S.A.
Maltese: FIS-SUQ Menarini International O. L.
English: Simvastatin: Simvastatin metabolism and clearance are highly dependent on CYP3A4.
Maltese: Il-metaboliżmu u r-rata ta' eliminazzjoni ta' simvastatin huma dipendenti bil-bosta fuq CYP3A4.
English: The above precautions are based on the risk in a CYP2D6 PM patient, and are needed when the CYP2D6 status is unknown.
Maltese: Il-prekawzjonijiet ta' hawn fuq huma bbażati fuq riskju f'pazjent CYP2D6 PM, u huma meħtieġa meta l-istatus ta' CYP2D6 ma jkunx magħruf.
English: Evaluations in patients who may be considered at higher risk of adverse events when treated with other antianginal medicinal products, e.g. patients with diabetes, Class I and II heart failure, or obstructive airway disease, confirmed that these conditions were not associated with clinically meaningful increases in the incidence of adverse events.
Maltese: Evalwazzjonijiet f'pazjenti li jistgħu jkunu kkunsidrati f'riskju ogħla ta' avvenimenti avversi meta kkurati bi prodotti mediċinali kontra l-anġina oħra, eż. pazjenti bid-dijabete, falliment tal-qalb Klassi I u II, jew mard li jostakola l-passaġġi ta' l-arja, ikkonfermaw li dawn il-kondizzjonijiet ma kinux assoċjati ma' żidiet klinikament sinifikattivi fl-inċidenza ta' reazzjonijiet avversi.
English: Österreich A. Menarini Pharma GmbH.
Maltese: Κύπρος MENARINI HELLAS AE
English: Grapefruit juice is also a potent CYP3A4 inhibitor.
Maltese: Il-meraq tal-grejpfrut huwa wkoll impeditur CYP3A4 qawwi.
English: Ranexa may cause side effects such as dizziness (common), blurred vision (uncommon), confusional state (uncommon), hallucination (uncommon), double vision (uncommon), coordination problems
Maltese: Ranexa tista' tikkaġuna effetti sekondarji bħalma huma sturdament (komuni), vista mċajpra (mhux komuni), stat konfużjonali (mhux komuni), alluċinazzjoni (mhux komuni), vista doppja (mhux komuni), problemi fil-koordinazzjoni (rari), li jistgħu jeffetwaw il-ħila tiegħek biex issuq jew tuża magni.
English: Drug-drug interactions: Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy.
Maltese: Għoti konkomittanti ma' indutturi CYP3A4 huwa mistenni li jwassal għal nuqqas fl-effikaċja.