FrancophonIA/ELRC3.0 huggingface dataset:
English: No proarrhythmic effects were observed in 3,162 patients treated with Ranexa based on 7-day Holter monitoring in the MERLIN-TIMI 36 study.
Maltese: L-ebda effetti proarritmiċi ma kienu osservati fi 3,162 pazjent ikkurati b'Ranexa abbażi ta' monitoraġġ Holter ta' 7 ijiem fl-istudju MERLIN-TIMI 36.
English: Uncommon: fatigue, peripheral oedema.
Maltese: Mhux komuni: għeja kbira, edima periferali.
English: Rare: pancreatitis, erosive duodenitis, oral hypoaesthesia.
Maltese: Rari: pankrejatite, duwodenite erożiva, ipoestiżja orali.
English: The terminal half-life at steady state after oral administration of ranolazine is about 7 hours, due to the absorption rate-limited elimination.
Maltese: Il-half-life terminali fi stat fiss wara għoti orali ta' ranolazine huwa madwar 7 sigħat, minħabba r-rata ta' eliminazzjoni limitata mill-assorbiment.
English: A large number of metabolites has been identified in human plasma (47 metabolites), urine (> 100 metabolites), and faeces (25 metabolites).
Maltese: Numru kbir ta' metaboliti ġew identifikati fil-plażma tal-bniedem (47 metabolit), fl-awrina (> 100 metabolit), u fl-ippurgar (25 metabolit).
English: Elderly patients: Age alone had no clinically relevant effect on pharmacokinetic parameters.
Maltese: L-età waħidha ma għandha l-ebda effett klinikament relevanti fuq parametri farmakokinetiċi.
English: The corresponding difference at the 1000 mg twice-daily dose was 25%.
Maltese: Id-differenza korrespondenti fid-doża ta' 1000 mg darbtejn kuljum kienet ta' 25%.
English: No significant difference occurred in the composite primary endpoint (time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation) in the ranolazine group (26.2%) versus the placebo group (28.3%), hazard ratio 0.95, 95% CI 0.82-1.10 p= 0.48.
Maltese: Ma seħħet l-ebda differenza sinifikanti fl-iskop finali primarju kompost (żmien għall-ewwel darba li seħħet rivaskularizzazzjoni mmexxija minn iskemija jew rikoverar l-isptar immexxi minn iskemija mingħajr rivaskularizzazzjoni) fil-grupp ta' ranolazine (26.2%) versus il-grupp tal-plaċebo (28.3%), proporzjon ta' periklu 0.95, 95% CI 0.82-1.10 p= 0.48.
English: The potential for inhibition of CYP2B6 has not been evaluated.
Maltese: Il-potenzjal għal impediment ta' CYP2B6 ma ġiex evalwat.
English: C]-ranolazine to healthy subjects, 73% of the radioactivity was recovered in urine and 25% in faeces.
Maltese: C]-ranolazine lil suġġetti f'saħħithom, 73% tar-radjuattività kienet irkuprata fl-awrina u 25% fl-ippurgar.
English: CYP3A4 or P-gp inhibitors: Ranolazine is a substrate of cytochrome CYP3A4.
Maltese: Impedituri CYP3A4 jew P-gp: Ranolazine huwa sottostrat ta' ċitokroma CYP3A4.
English: Paediatric population: The pharmacokinetic parameters of ranolazine have not been studied in the paediatric population (< 18 years).
Maltese: Il-parametri farmakokinetiċi ta' ranolazine ma ġewx studjati fil-popolazzjoni pedjatrika (< 18-il sena).
English: Muscle weakness.
Maltese: Indebboliment muskolari.
English: Rare side effects (occur in 1 to 10 users in 10,000) are:
Maltese: Effetti sekondarji rari (iseħħu f'1 sa 10 utenti minn kull 10,000) huma:
English: • Patients with low weight (≤ 60 kg) (see sections 4.2, 4.8, and 5.2).
Maltese: • Pazjenti b'piż baxx (≤ 60 kg) (ara sezzjonijiet 4.2, 4.8, u 5.2).
English: Inflammation of pancreas or intestine
Maltese: Infjammazzjoni tal-pankreas jew intestini
English: Elimination: Ranolazine is eliminated primarily by metabolism.
Maltese: Ranolazine huwa eliminat primarjament permezz tal-metaboliżmu.
English: Renal impairment: Renal function decreases with age and it is therefore important to check renal function at regular intervals during treatment with ranolazine (see sections 4.2, 4.3, 4.8, and 5.2).
Maltese: Il-funzjoni tal-kliewi tonqos ma' l-età u huwa għaldaqstant importanti li tiċċekkja l-funzjoni tal-kliewi f'intervalli regolari waqt il-kura b'ranolazine (ara sezzjonijiet 4.2, 4.3, 4.8, u 5.2).
English: In a pharmacokinetic study in healthy volunteers, steady-state Cmax was, on average, approximately 1770 (SD 1040) ng/ml, and steady-state AUC0-12 was, on average, 13,700 (SD 8290) ng x h/ml following a dose of 500 mg twice daily.
Maltese: Fi studju farmakokinetiku f'voluntieri f'saħħithom, is- Cmax ta' stat fiss kienet, bejn wieħed u ieħor, medja ta' 1770 (SD 1040) ng/ml, u l-AUC0-12 ta' stat fiss kienet, medja ta', 13,700 (SD 8290) ng x h/ml, wara doża ta' 500 mg darbtejn kuljum.
English: Pharmacotherapeutic group: Other cardiac preparations, ATC code: C01EB18
Maltese: Kategorija farmakoterapewtika: Preparazzjonijiet kardijaċi oħra, Kodiċi ATC:
English: INFORMATION IN BRAILLE Ranexa 500 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ranexa 500 mg
English: CYP2D6 inhibitors: Ranolazine is partially metabolised by CYP2D6; therefore, inhibitors of this enzyme may increase plasma concentrations of ranolazine.
Maltese: Ranolazine huwa parzjalment metabolizzat minn CYP2D6; għaldaqstant, impedituri ta' din l-enzima jistgħu jżidu l-konċentrazzjonijiet ta' ranolazine fil-plażma.
English: Distribution: Approximately 62% of ranolazine is bound to plasma proteins, mainly alpha-1 acid glycoprotein and weakly to albumin.
Maltese: Madwar 62% ta' ranolazine jeħel ma' proteini fil-plażma, prinċipalment alpha-1 acid glycoprotein u b'mod dgħajjef ma' albumin.
English: Ranexa 375 mg prolonged-release tablets Ranexa 500 mg prolonged-release tablets Ranexa 750 mg prolonged-release tablets
Maltese: Ranexa 375 mg pilloli li jerħu l-mediċina bil-mod Ranexa 500 mg pilloli li jerħu l-mediċina bil-mod Ranexa 750 mg pilloli li jerħu l-mediċina bil-mod
English: In a large outcome study (MERLIN-TIMI 36) in 6,560 patients with UA/NSTEMI ACS, there was no difference in the risk of all-cause mortality (relative risk ranolazine:placebo 0.99), sudden cardiac death (relative risk ranolazine:placebo 0.87), or the frequency of symptomatic documented arrhythmias (3.0% versus 3.1%) between Ranexa and placebo when added to standard medical therapy (including beta-blockers, calcium channel blockers, nitrates, anti-platelet agents, lipid-lowering medicinal products, and ACE inhibitors).
Maltese: Fi studju ta' riżultat kbir (MERLIN-TIMI 36) f'6,560 pazjent b'UA/NSTEMI ACS, ma kien ebda differenza fir-riskju tal-mortalità b'kull kawża (riskju relattiv ranolazine:plaċebo 0.99), mewta kardijaka f'daqqa (riskju relattiv ranolazine:plaċebo 0.87), jew il-frekwenza ta' l-arritmiji sintomatiċi dokumentati (3.0% kontra 3.1%) bejn Ranexa u placebo meta miżjuda ma' terapija medika standard (inklużi mblokkaturi-beta, imblokkaturi tal-kanali tal-kalċju, nitrati, mediċini kontra l-pjastrini, prodotti mediċinali li jbaxxu l-lipidi u impedituri ACE).
English: Concomitant treatment with CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended in patients treated with moderate CYP3A4 inhibitors (e.g. diltiazem, fluconazole, erythromycin) or P-gp inhibitors (e.g. verapamil, ciclosporin) (see sections 4.4 and 4.5).
Maltese: Kura konkomittanti b'impedituri CYP3A4 u P-glycoprotein (P-gp): Hija rrakkomandata titrazzjoni bir-reqqa f'pazjenti kkurati b'impedituri CYP3A4 moderati (eż. diltiazem, fluconazole, erythromycin) jew impedituri P-gp (eż. verapamil, ciclosporin) (ara sezzjonijiet 4.4 u 4.5).
English: INFORMATION IN BRAILLE Ranexa 375 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ranexa 375 mg
English: A renal function study in healthy volunteers demonstrated a reduction in creatinine clearance with no change in glomerular filtration rate consistent with inhibition of renal tubular secretion of creatinine.
Maltese: Studju ta' funzjoni tal-kliewi f'voluntiera f'saħħithom wera tnaqqis fir-rata ta' eliminazzjoni ta' kreatinina mingħajr l-ebda bidla fir-rata ta' filtrazzjoni glomerulari konsistenti ma' impediment ta' tnixxija tubulari tal-kliewi ta' kreatinina.
English: Diltiazem (180 to 360 mg once daily), a moderately potent CYP3A4 inhibitor, causes dose-dependent increases in average ranolazine steady-state concentrations of 1.5- to 2.4-fold.
Maltese: Diltiazem (180 sa 360 mg darba kuljum), impeditur CYP3A4 moderatament qawwi, jikkaġuna żidiet dipendenti fuq id-doża f'konċentrazzjonijiet medji ta' ranolazine fi stati stabbli ta' 1.5- sa 2.4-il darba.
English: EXP
Maltese: SpA
English: The active substance in Ranexa is ranolazine.
Maltese: Is-sustanza attiva f'Ranexa hija ranolazine.
English: Available data suggest that ranolazine is a mild inhibitor of CYP2D6.
Maltese: Dejta disponibbli tissuġġerixxi li ranolazine huwa impeditur ħafif ta' CYP2D6.
English: Each tablet contains 375 mg, 500 mg, or 750 mg ranolazine.
Maltese: Kull pillola fiha 375 mg, 500 mg, jew 750 mg ta' ranolazine.
English: Germany or
Maltese: Slovenská republika
English: • Concomitant administration of moderate CYP3A4 inhibitors (see sections 4.2 and 4.5).
Maltese: • Għoti ta' impedituri CYP3A4 moderati flimkien(ara sezzjonijiet 4.2 u 4.5).
English: For the full list of excipients see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: In long-term carcinogenicity studies at doses of ranolazine up to 50 mg/kg/day (150 mg/m 2/day) in mice and 150 mg/kg/day (900 mg/m2/day) in rats, no relevant increases in the incidence of any tumour types were seen.
Maltese: Fi studji ta' karċinoġeniċità f'dożi ta' ranolazine sa 50 mg/kg/kuljum (150 mg/m 2/kuljum) fil-ġrieden u 150 mg/kg/kuljum (900 mg/m2/kuljum) fil-firien, ma ntwerew l-ebda żidiet relevanti fl-inċidenza ta' xi tipi ta' tumuri.
English: Rare: elevated levels of hepatic enzyme.
Maltese: Rari: livelli għoljin ta' enżimi epatiċi.
English: INFORMATION IN BRAILLE Ranexa 750 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ranexa 750 mg
English: Ear and labyrinth disorders Uncommon: vertigo, tinnitus.
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Mhux komuni: vertiġini, tinnitus.
English: In patients with mild or moderate renal impairment (creatinine clearance ≥ 30-80 ml/min) compared to those with normal renal function (creatinine clearance > 80 ml/min), the most commonly reported events and their placebo-corrected frequencies included: constipation (8% versus 4%), dizziness (7% versus 5%), and nausea (4% versus 2%).
Maltese: F'pazjenti b'indeboliment tal-kliewi ħafif jew moderat (rata ta' eliminazzjoni ta' kreatinina ≥ 30-80 ml/min u ≤ 80 ml/min) meta mqabbla ma' dawk b'funzjoni tal-kliewi normali (rata ta' eliminazzjoni ta' kreatinina > 80 ml/min), l-aktar avvenimenti rrapportati b'mod komuni u l-frekwenzi korretti bi plaċebo nkludew: stitikezza (8% kontra 4%), sturdament (7% kontra 5%), u dardir (4% kontra 2%).
English: At 500 mg twice daily, subjects lacking CYP2D6 activity (poor metabolisers, PM) had 62% higher AUC than subjects with CYP2D6 metabolising capacity (extensive metabolisers, EM).
Maltese: F'500 mg darbtejn kuljum, suġġetti li m'għandhomx attività CYP2D6 (metabolizzaturi dgħajfin, PM) kellhom l-AUC 62% aktar għolja minn suġġetti b'kapaċità metabolizzanti CYP2D6 (metabolizzaturi estensivi, EM).
English: Verapamil (120 mg three times daily) increases ranolazine steady-state concentrations 2.2-fold.
Maltese: Verapamil (120 mg tliet darbiet kuljum) iżid il-konċentrazzjonijiet ta' stat-fiss ta' ranolazine bi 2.2-il darba.
English: Inhibitors of P-gp (e.g. ciclosporin, verapamil) increase plasma levels of ranolazine.
Maltese: Impedituri ta' P-gp (eż. ciclosporin, verapamil) iżidu livelli ta' ranolazine fil-plażma.
English: Dehydration
Maltese: Disorjentazzjoni
English: Rare: amnesia, depressed level of consciousness, loss of consciousness, coordination abnormal, gait disturbance, parosmia.
Maltese: Rari: amneżija, tnaqqis fil-livell tas-sensi, telf tas-sensi, koordinazzjoni anormali, disturbi fil-qagħda,
English: Drugs transported by the Organic Cation Transporter-2 (OCT2): Plasma exposure of metformin (1000 mg twice daily) increased 1.4- and 1.8-fold in subjects with type 2 diabetes mellitus when coadministered with RANEXA 500 mg and 1000 mg twice daily respectively.
Maltese: Mediċini li jinġarru mit-Trasportatur Ketajoniku Organiku-2 (OCT2): L-esponiment ta' metformin (1000 mg darbtejn kuljum) fil-plażma żdied b'1.4- u 1.8-il darba f'individwi b'dijabete mellitus tattip 2 meta ngħata ma' RANEXA 500 mg u 1000 mg darbtejn kuljum rispettivament.
English: Inhibitors of CYP3A4 increase plasma concentrations of ranolazine.
Maltese: Impedituri ta' CYP3A4 iżidu l-konċentrazzjoniet ta' ranolazine fil-plażma.
English: Gender effects: Gender had no clinically relevant effect on pharmacokinetic parameters.
Maltese: Is-sess m'għandu l-ebda effett klinikament relevanti fuq parametri farmokokinetiċi.
English: Clinical evidence of inhibition of the late sodium current by ranolazine is provided by a significant shortening of the QTc interval and an improvement in diastolic relaxation in an open-label study of 5 patients with a long QT syndrome (LQT3 having the SCN5A ΔKPQ gene mutation).
Maltese: Evidenza klinika ta' impediment tal-kurrent ittardjat tas-sodju permezz ta' ranolazine hija pprovduta permezz ta' tqassir sinifikattiv ta' l-intervall QTc u titjib fir-rilassament dijastoliku fi studju b'tikketta miftuħa ta' 5 pazjenti b'sindromu QT twil (LQT3 ikollu mutazzjoni ta' ġene SCN5A ΔKPQ).
English: In the pivotal study, CARISA, Ranexa was added to treatment with atenolol 50 mg once daily, amlodipine 5 mg once daily, or diltiazem 180 mg once daily.
Maltese: Fl-istudju ewlieni, CARISA, Ranexa kienet miżjuda ma' kura b'atenolol 50 mg darba kuljum, amlodipine 5 mg darba kuljum, jew diltiazem 180 mg darba kuljum.
English: • Mild to moderate renal impairment (creatinine clearance 30-80 ml/min) (see sections 4.2, 4.8,
Maltese: • Indeboliment tal-kliewi ħafif għal moderat (tneħħija tal-kreatininae 30-80 ml/min) (ara sezzjonijiet 4.2, 4.8, u 5.2).
English: Also, transient ischemic attack occurred more frequently in patients treated with ranolazine 1000 mg twice daily compared with placebo (1.0% vs 0.2%, respectively); however, the incidence of stroke was similar between treatment groups (ranolazine 1.7% vs placebo 1.5%).
Maltese: Barra dan, attakk iskemiku temporanju seħħ b'mod aktar frekwenti f'pazjenti ttrattati b'ranolazine 1,000 mg darbtejn kuljum meta mqabbel mal-plaċebo (1.0% vs 0.2%, rispettivament); madankollu, l-inċidenza ta' puplesija kienet simili bejn il-gruppi ta' trattament (ranolazine 1.7% vs plaċebo 1.5%).
English: Severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.2 and 5.2).
Maltese: Indeboliment tal-kliewi severi (rata ta' tneħħija ta' kreatinina < 30 ml/min) (ara sezzjonijiet 4.2 u 5.2).
English: In a large outcome study (MERLIN-TIMI 36) in 6,560 patients with UA/NSTEMI ACS, there was no difference between Ranexa and placebo in the risk of all-cause mortality (relative risk ranolazine:placebo 0.99), sudden cardiac death (relative risk ranolazine:placebo 0.87), or the frequency of symptomatic documented arrhythmias (3.0% versus 3.1%).
Maltese: Fi studju (MERLIN-TIMI 36) ta' effett kbir f'6,560 pazjent b'UA/NSTEMI ACS, ma kien hemm l-ebda differenza bejn Ranexa u plaċebo fir-riskju ta' mortalità mill-kaġunijiet kollha (riskju relattiv ranolazine:plaċebo 0.99), mewt kardijaka f'daqqa waħda (riskju relattiv ranolazine:plaċebo 0.87), jew il-frekwenza ta' arritmiji sintomatiċi dokumentati (3.0% kontra 3.1%).
English: In subjects with severe renal impairment (creatinine clearance 10-30 ml/min), a 1.3- to 1.8-fold increase in ranolazine exposure was estimated.
Maltese: F'suġġetti b'indeboliment tal-kliewi sever (rata ta' eliminazzjoni ta' kreatinina 10-30 ml/min), kienet stmata żieda ta' 1.3 sa 1.8 drabi fl-esponiment ta' ranolazine.
English: Tissue distribution of drugs which are transported by P-gp may be increased.
Maltese: Tista' tiżdied id-distribuzzjoni fit-tessuti ta' mediċini li huma trasportati minn P-gp.
English: Ranexa 750 mg twice daily increased plasma concentrations of metoprolol by 1.8-fold.
Maltese: Ranexa 750 mg darbtejn kuljum żiedet il-konċentrazzjonijiet ta' metoprolol fil-plażma b'1.8-il darba.
English: Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) (see sections 4.2 and 4.5).
Maltese: Għoti ta' impedituri CYP3A4 qawwija flimkien (eż. itraconazole, ketoconazole, voriconazol, posaconazol, impedituri HIV protease, clarithromycin, telithromycin, nefazodone) (ara sezzjonijiet 4.2 u 4.5).
English: PVC/PVDC/Aluminium blisters of 15 or 20 tablets per blister card. Each carton contains 2, 3, or 5 blister cards (30, 60, or 100 tablets) or one HDPE bottle containing 60 tablets.
Maltese: Kull kartuna fiha 2, 3, jew 5 folji (30, 60, jew 100 pillola) jew flixkun HDPE li fih 60 pillola.
English: Down-titration of Ranexa may be required (see sections 4.2 and 4.4).
Maltese: Jista' jkun hemm bżonn ta' titrazzjoni 'l isfel ta' Ranexa (ara sezzjonijiet 4.2 u 4.4).
English: Ranolazine is a moderate to potent inhibitor of P-gp and a mild inhibitor of CYP3A4, and may increase plasma concentrations of P-gp or CYP3A4 substrates.
Maltese: Ranolazine huwa impeditur ta' P-gp moderat għal qawwi u impeditur ħafif ta' CYP3A4, u jista' jżid il-konċentrazzjonijiet fil-plażma ta' sottostrati ta' P-gp jew CYP3A4.
English: The Seattle Angina Questionnaire showed significant effects on several dimensions, including angina frequency (p < 0.001), compared to placebo-treated patients.
Maltese: Il-Kwestjonarju ta' Seattle dwar lAnġina wera effetti sinjifikanti fuq bosta dimensjonijiet, inkluż il-frekwenza ta' l-anġina (p < 0.001), meta mqabbel ma' pazjenti ttrattati bi plaċebo.
English: CYP3A4 inducers: Rifampicin (600 mg once daily) decreases ranolazine steady-state concentrations by approximately 95%.
Maltese: Rifampicin (600 mg darba kuljum) inaqqas il-konċentrazzjonijiet ta' stat-fiss ta' ranolazine b'madwar 95%.
English: In the population pharmacokinetic analysis, a 1.2-fold increase in ranolazine exposure was estimated in subjects with moderate impairment (creatinine clearance 40 ml/min).
Maltese: F'analiżi tal-farmakokinetiċi tal-popolazzjoni, żieda fl-esponiment ta' ranolazine ta' 1.2-il darba kienet stmata f'suġġetti b'indeboliment moderat (rata ta' eliminazzjoni ta' kreatinina 40 ml/min).
English: The elimination half-life is about 2−3 hours after intravenous administration.
Maltese: Il-halflife ta' l-eliminazzjoni hija madwar 2−3 sigħat wara għoti intravenuż.
English: The incidence of adverse events was higher in the elderly (see section 4.8).
Maltese: L-inċidenza ta' episodji avversi fl-anzjani kienet aktar għolja (ara sezzjoni 4.8).
English: Ελλάδα MENARINI HELLAS AE Τηλ: +30 210 8316111-13
Maltese: Τηλ: +30 210 8316111-13
English: Haemodynamic effects: Minimal decreases in mean heart rate (< 2 beats per minute) and mean systolic blood pressure (< 3 mm Hg) were observed in patients treated with ranolazine either alone or in combination with other antianginal medicinal products in controlled studies.
Maltese: Tnaqqis minimu fir-rata tal-qalb medja (< 2 taħbitiet kull minuta) u fil-pressjoni tad-demm sistolika medja (< 3 mm Hg) kien osservat f'pazjenti kkurati b'ranolazine kemm waħdu jew f'kumbinazzjoni ma' prodotti mediċinali kontra l-anġina fi studji kkontrollati.
English: In a second study, ERICA, Ranexa was added to treatment with amlodipine 10 mg once daily (the maximum labelled dose).
Maltese: Fit-tieni studju, ERICA, Ranexa kienet miżjuda ma' kura ta' amlodipine 10 mg darba kuljum (id-doża massima ittikkettjata).
English: This value is consistent with data from pivotal clinical studies, where mean changes from baseline in QTcF (Fridericia's correction) after doses of 500 and 750 mg twice daily were 1.9 and 4.9 msec, respectively.
Maltese: Dan il-valur huwa konsistenti ma' dejta minn studji kliniċi tal-pern, fejn tibdiliet medji mil-linja bażi fil-QTcF (korrezzjoni ta' Fridericia), wara dożi ta' 500 u 750 mg darbtejn kuljum, kienu 1.9 u 4.9 msec, rispettivament.
English: • Concomitant administration of P-gp inhibitors (see sections 4.2 and 4.5).
Maltese: • Għoti ta' impedituri P-gp flimkien (ara sezzjonijiet 4.2 u 4.5).
English: Uncommon: anxiety, insomnia, confusional state, hallucination.
Maltese: Mhux komuni: ansjetà, insomnja, stat konfużjonali, alluċinazzjoni.
English: There is a theoretical risk that concomitant treatment of ranolazine with other drugs known to prolong the QTc interval may give rise to a pharmacodynamic interaction and increase the possible risk of ventricular arrhythmias.
Maltese: interazzjoni farmakodinamika u jżidu r-riskju ta' arritmiji ventrikulari.
English: Examples of such drugs include certain antihistamines (e.g. terfenadine, astemizole, mizolastine), certain antiarrhythmics (e.g. quinidine, disopyramide, procainamide), erythromycin, and tricyclic antidepressants (e.g. imipramine, doxepin, amitriptyline).
Maltese: Eżempji ta' mediċini minn dawn jinkludu ċerti antiħistamini (eż. terfenadine, astemizole, mizolastine), ċerti antiarritmiċi (eż. quinidine, disopyramide, procainamide), erythromycin, u antidepressanti triċikliċi (eż. imipramine, doxepin, amitriptyline).
English: Elderly, renal impairment, and low weight: In general, adverse events occurred more frequently among elderly patients and patients with renal impairment; however, the types of events in these subgroups were similar to those observed in the general population.
Maltese: B'mod ġenerali, avvenimenti avversi seħħew aktar frekwenti fost pazjenti anzjani u pazjenti b'indeboliment tal-kliewi; madankollu, it-tipi ta' avvenimenti f'dawn is-sottogruppi kienu simili għal dawk osservati fil-popolazzjoni ġenerali.
English: Biotransformation: Ranolazine undergoes rapid and extensive metabolism.
Maltese: Ranolazine jgħaddi minn metaboliżmu rapidu u estensiv.
English: Lot
Maltese: Talc
English: The risk of all cause mortality, CV death or major adverse cardiovascular events (MACE) and heart failure hospitalisation was similar between treatment groups in the overall population; however, MACE were reported more frequently in patients ≥ 75 years treated with ranolazine compared with placebo (17.0% vs 11.3%, respectively); in addition there was a numerical increase in all cause mortality in patients ≥ 75 years (9.2% vs. 5.1%, p = 0.074).
Maltese: Ir-riskju ta' mortalità minn kull kawża, mewt CV jew avventimeti avversi kardjovaskulari maġġuri (MACE, major adverse cardiovascular events) u rikoverar l-isptar minħabba insuffiċjenza tal-qalb kien simili bejn il-gruppi ta' trattament fil-popolazzjoni globali; madankollu, MACE kienu irrappurtati aktar frekwenti f'pazjenti ≥ 75 sena ttrattati b'ranolazine meta mqabbla mal-plaċebo (17.0% vs 11.3%, rispettivament); barra dan kien hemm żidiet numeriċi fil-mortalità minn kull kawża f'pazjenti ≥ 75 sena (9.2% vs. 5.1%, p = 0.074).
English: Caution is advised during co-administration with CYP2B6 substrates (e.g. bupropion, efavirenz, cyclophosphamide).
Maltese: Huwa rrakkomandat li tintuża l-kawtela waqt għoti konkomittanti ma' sottostrati CYP2B6 (eż. bupropion, efavirenz, cyclophosphamide).
English: In a phase 3, double-blind, placebo-controlled, event-driven trial (RIVER-PCI) in 2604 patients aged ≥18 years with a history of chronic angina and incomplete revascularisation after percutaneous coronary intervention (PCI) patients were up-titrated to 1000 mg twice daily (dosage not approved in the current SmPC).
Maltese: Fi prova ta' fażi 3, ikkontrollata bi plaċebo, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, immexxija mill-avvenimenti (RIVER-PCI) f'2,604 pazjenti b'età ≥18-il sena bi storja ta' anġina kronika u rivaskularizzazzjoni mhux kompluta wara intervent perkutanju koronarju (PCI) il-pazjenti żdiditilhom id-doża ftit ftit għal 1,000 mg darbtejn kuljum (dożaġġ li mhuwiex approvat fl-SmPC attwali).
English: The influence of various factors on the pharmacokinetics of ranolazine was assessed in a population pharmacokinetic evaluation in 928 angina patients and healthy subjects.
Maltese: L-influwenza ta' fatturi diversi fuq il-farmakokinetiċi ta' ranolazine kienu stmati f'evalwazzjoni farmakokinetika tal-popolazzjoni f'928 pazjent b'anġina u suġġetti b'saħħithom.