FrancophonIA/ELRC3.0 huggingface dataset:
English: Number of Pulmonary exacerbations (events) ** † *** Number of events per patient- year (95% CI) (rate per 48 wks)
Maltese: Numru ta' avvenimenti għal kull sena ta' pazjent (95% CI) (rata kull 48 ġimgħa)
English: ↓ repaglinide Due to induction of CYP3A/2C8 by LUM
Maltese: ↓ repaglinide Minħabba linduzzjoni ta' CYP3A/2C8 minn LUM
English: Package leaflet: Information for the patient Orkambi 100 mg/125 mg granules in sachet Orkambi 150 mg/188 mg granules in sachet lumacaftor/ivacaftor
Maltese: Informazzjoni għall-pazjent Orkambi 100 mg/125 mg granijiet f'qartas Orkambi 150 mg/188 mg granijiet f'qartas lumacaftor/ivacaftor
English: The impact of mild hepatic impairment (Child-Pugh Class A, score 5 to 6) on pharmacokinetics of lumacaftor given in combination with ivacaftor has not been studied, but the increase in exposure is expected to be less than 50%.
Maltese: L-impatt ta' indeboliment ħafif tal-fwied (Child-Pugh Klassi A, punteġġ minn 5 sa 6) fuq il-farmakokinetika ta' lumacaftor mogħti flimkien ma' ivacaftor, ma ġiex studjat, iżda ż-żieda fl-esponiment hi mistennija li tkun inqas minn 50%.
English: The percentage of patients with heart rate values < 50 bpm on treatment was 11% for patients who received lumacaftor/ivacaftor, compared to 4.9% for patients who received placebo.
Maltese: Il-perċentwali ta' pazjenti b'valuri tar-rata tal-qalb ta' <50 bpm li kienu fuq ilkura, kienet 11% għal pazjenti li rċivew lumacaftor/ivacaftor, meta mqabbla ma' 4.9% għal pazjenti li rċivew plaċebo.
English: Primary Endpoint Absolute change in lung clearance index (LCI2.5) from baseline through Week 24
Maltese: Punt Aħħari Primarju Bidla assoluta fl-indiċi tattneħħija mill-kliewi (LCI2.5) mil-linja sa Ġimgħa 24
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 ppreżentatirapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikatfuq ilportal elettroniku Ewropew tal-mediċini.
English: Clinical comment
Maltese: KLINIKU
English: The proportion of patients who experienced a systolic blood pressure value > 140 mmHg or a diastolic blood pressure > 90 mmHg on at least two occasions was 3.4% and 1.5% in patients treated with lumacaftor/ivacaftor, respectively, compared with 1.6% and 0.5% in patients who received placebo (see section 4.4).
Maltese: Il-proporzjon ta' pazjenti li kellhom valur ta' pressjoni sistolika tad-demm ta' >140 mmHg jew pressjoni dijastolika tad-demm ta' >90 mmHg f'mill-inqas żewġ okkażjonijiet, kien ta' 3.4% u l-1.5% f'pazjenti kkurati b'lumacaftor/ivacaftor, rispettivament, meta mqabbla ma' 1.6% u 0.5% f'pazjenti li rċivew plaċebo (ara sezzjoni 4.4).
English: These menstrual events occurred more frequently in the subset of female patients who were taking hormonal contraceptives (25.0%) versus patients who were not taking hormonal contraceptives (3.5%) (see section 4.5).
Maltese: 0%) kontra pazjenti li ma kinux qed jieħdu kontraċettivi ormonali (3.5%) (ara sezzjoni 4.5).
English: Trial 7 evaluated subjects with lung clearance index (LCI2.5) ≥ 7.5 at the initial screening visit (mean LCI2.5 10.28 at baseline [range: 6.55 to 16.38]) and ppFEV1 ≥ 70 at screening (mean ppFEV1 89.8 at baseline [range: 48.6 to 119.6]).
Maltese: 38]) u ppFEV1 ≥70 fl-iscreening (medja ta' ppFEV1 89.8 fil-linja bażi [medda: 48.6 sa 119.6]).
English: • Upper respiratory tract infection
Maltese: Pazjenti wara trapjant tal-organi
English: The safety data from 1029 patients aged 12 years and older who were homozygous for the F508del mutation in the CFTR gene treated with lumacaftor/ivacaftor for up to an additional 96 weeks in the long-term safety and efficacy rollover study (Trial 3) were similar to the 24-week, placebo-controlled studies (see section 5.1).
Maltese: Id-dejta dwar is-sigurtà minn 1029 pazjent li kellhom 12-il sena u aktar li kienu omożigoti għallmutazzjoni F508del fil-ġene CFTR ikkurati b'lumacaftor/ivacaftor sa 96 ġimgħa addizzjonali fl-istudju rollover dwar is-sigurtà u l-effikaċja fit-tul (Prova 3) kienu simili għall-istudji li damu 24 ġimgħa, ikkontrollati bi plaċebo (ara sezzjoni 5.1).
English: Rate ratio
Maltese: U KWANTITATTIVA
English: • Common cold*
Maltese: • Riħ komuni*
English: Orkambi 100 mg/125 mg
Maltese: 6 sa 11-il sena Orkambi 100 mg/125 mg
English: Ivacaftor produced a dose-related but transient increase in the blood pressure parameters in dogs at single oral doses up to 60 mg/kg.
Maltese: Ivacaftor ipproduċa żieda relatata mad-doża, iżda temporanja, fil-parametri tal-pressjoni tad-demm fil-klieb f'dożi orali waħidhom ta' sa 60 mg/kg.
English: However, when initiating Orkambi in patients taking strong CYP3A inhibitors, the dose should be reduced to one tablet daily (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 6 to 11 years; lumacaftor 200 mg/ivacaftor 125 mg for patients aged 12 years and older) for the first week of treatment to allow for the steady state induction effect of lumacaftor.
Maltese: Madankollu, meta jinbeda Orkambi f'pazjenti li jkunu qed jieħdu inibituri qawwija ta' CYP3A, id-doża għandha titnaqqas għal pillola waħda kuljum (lumacaftor 100 mg/ivacaftor 125 mg għal pazjenti li jkollhom minn 6 sa 11-il sena; lumacaftor 200 mg/ivacaftor 125 mg għal pazjenti li jkollhom 12-il sena u aktar) għall-ewwel ġimgħa ta' kura, biex jiġi kkunsidrat l-effett ta' induzzjoni fl-istat fiss ta' lumacaftor.
English: Ivacaftor was not teratogenic when dosed orally to pregnant rats and rabbits during the organogenesis stage of foetal development at doses approximately 7 times (ivacaftor and metabolite exposure) and 46 times the ivacaftor exposure in humans at the therapeutic lumacaftor/ivacaftor dose, respectively.
Maltese: Id-dożaġġ ta' ivacaftor ma kienx teratoġeniku meta ngħata mill-ħalq lil firien u fniek tqal matul il-fażi tal-organoġenesi tal-iżvilupp tal-fetu f'dożi ta' madwar 7 darbiet (esponiment ta' ivacaftor u lmetabolit) u 46 darba tal-esponiment ta' ivacaftor fil-bnedmin fid-doża terapewtika ta' lumacaftor/ivacaftor, rispettivament.
English: Odds ratio
Maltese: mhux komuni
English: Patients aged 6 to 11 years lumacaftor 200 mg/ivacaftor 250 mg every 12 hours
Maltese: Pazjenti li kellhom 6 sa 11il sena lumacaftor 200 mg/ivacaftor 250 mg kull 12-il siegħa
English: The effect of gender on lumacaftor pharmacokinetics was evaluated using a population pharmacokinetics analysis of data from clinical studies of lumacaftor given in combination with ivacaftor.
Maltese: L-interazzjonijiet tal-mediċina li għandhom l-aktar rilevanza klinika huma elenkati l-ewwel.
English: Additionally, in vitro studies suggest that ivacaftor may inhibit CYP2C9.
Maltese: Ukoll, studji in vitro jissuġġerixxu li ivacaftor jista' jinibixxi CYP2C9.
English: In the event of significant elevation of ALT or AST, with or without elevated bilirubin (either ALT or AST > 5 x the upper limit of normal [ULN], or ALT or AST > 3 x ULN with bilirubin > 2 x ULN), dosing with lumacaftor/ivacaftor should be discontinued and laboratory tests closely followed until the abnormalities resolve.
Maltese: Fil-każ ta' żieda sinifikanti ta' ALT jew AST, bi jew mingħajr żieda fil-bilirubina (jew ALT jew AST ta' > 5 x il-limitu ta' fuq tan-normal [ULN], jew ALT jew AST ta' > 3 x ULN b'bilirubina ta' > 2 x ULN), id-dożaġġ b'lumacaftor/ivacaftor għandu jitwaqqaf u testijiet tal-laboratorju għandhom jiġu segwiti mill-qrib sakemm l-anormalitajiet jgħaddu.
English: During the 24-week, placebo-controlled, Phase 3 studies, a maximum decrease in mean heart rate of 6 beats per minute (bpm) from baseline was observed on Day 1 and Day 15 around 4 to 6 hours after dosing.
Maltese: Matul l-istudji ta' Fażi 3 li damu 24 ġimgħa, ikkontrollati bi plaċebo, tnaqqis massimu fil-medja tarrata tal-qalb ta' 6 taħbitiet kull minuta (bpm) mil-linja bażi, ġie osservat f'Jum 1 u Jum 15, madwar 4 sa 6 sigħat wara l-għoti tad-dożaġġ.
English: For patients aged 12 years and older 600 mg lumacaftor + 375 mg ivacaftor
Maltese: 600 mg lumacaftor + 375 mg ivacaftor
English: Orkambi 100 mg/125 mg film-coated tablets and Orkambi 200 mg/125 mg film-coated tablets: The other ingredients are:
Maltese: Orkambi 100 mg/125 mg pilloli miksija b'rita u Orkambi 200 mg/125 mg pilloli miksija b'rita:
English: ↔ LUM, IVA ↑ or ↓ dabigatran
Maltese: ISTRUZZJONIJIET DWAR L­UŻU
English: According to their weight at screening, patients were administered granules mixed with food every 12 hours, at a dose of lumacaftor 100 mg/ivacaftor 125 mg granules for patients weighing less than14 kg (n = 19) or lumacaftor 150 mg/ivacaftor 188 mg for patients weighing 14 kg or greater (n = 41), for 24 weeks in addition to their prescribed CF therapies.
Maltese: Skont il-piż tagħhom fl-iscreening, il-pazjenti ngħataw granijiet imħallta mal-ikel kull 12-il siegħa, b'doża ta' lumacaftor 100 mg/ivacaftor 125 mg granijiet għal pazjenti li jiżnu inqas minn 14-il kg (n = 19) jew lumacaftor 150 mg/ivacaftor 188 mg għal pazjenti li jiżnu 14-il kg jew iktar (n = 41), għal 24 ġimgħa flimkien mat-terapiji ta' CF preskritti tagħhom.
English: Within-group change
Maltese: Ir-Renju Unit
English: In vitro studies indicate that lumacaftor is a substrate of Breast Cancer Resistance Protein (BCRP).
Maltese: Studji in vitro jindikaw li lumacaftor hu substrat tal-Proteina ta' Reżistenza għall-Kanċer tas-Sider (BCRP).
English: Established and other potentially significant drug interactions Table 3 provides the established or predicted effect of lumacaftor/ivacaftor on other medicinal products or the effect of other medicinal products on lumacaftor/ivacaftor.
Maltese: Interazzjonijiet stabbiliti tal-mediċina u interazzjonijiet potenzjalment sinifikanti oħrajn Tabella 3 tipprovdi l-effett stabbilit jew imbassar ta' lumacaftor/ivacaftor fuq prodotti mediċinali oħrajn, jew l-effett ta' prodotti mediċinali oħrajn fuq lumacaftor/ivacaftor.
English: Seven patients who received lumacaftor/ivacaftor had liver-related serious adverse events with elevated transaminases, including 3 with concurrent elevation in total bilirubin.
Maltese: Seba' pazjenti li rċivew lumacaftor/ivacaftor kellhom avvenimenti avversi serji relatati mal-fwied b'livelli għoljin ta' transaminases, li kienu jinkludu 3 b'żieda fl-istess ħin talbilirubina totali.
English: The side effects reported with Orkambi and ivacaftor alone (one of the active substances of Orkambi) are listed below and may occur with the use of Orkambi.
Maltese: L-effetti sekondarji rrappurtati b'Orkambi u ivacaftor waħdu (wieħed mis-sustanzi attivi ta' Orkambi) huma elenkati hawn taħt u jistgħu jseħħu bl-użu ta' Orkambi.
English: ↓ clarithromycin, telithromycin Due to induction of CYP3A by LUM
Maltese: ↓ clarithromycin, telithromycin Minħabba linduzzjoni ta' CYP3A minn LUM
English: The exposure of ivacaftor is similar between healthy adult volunteers and patients with CF. After twice-daily dosing, steady-state plasma concentrations of lumacaftor and ivacaftor in healthy subjects were generally reached after approximately 7 days of treatment, with an accumulation ratio of approximately 1.9 for lumacaftor.
Maltese: Wara dożaġġ ta' darbtejn kuljum, il-konċentrazzjonijiet ta' lumacaftor u ivacaftor fil-plażma fl-istat fiss f'individwi b'saħħithom, ġeneralment intlaħqu wara madwar 7 ijiem ta' kura, bi proporzjon ta' akkumulazzjoni ta' madwar 1.9 għal lumacaftor.
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 100 mg ta' lumacaftor u 125 mg ta' ivacaftor.
English: * Trial included key secondary and other secondary endpoints.
Maltese: * Il-prova kienet tinkludi punti aħħarin sekondarji ewlenin u punti aħħarin sekondarji oħrajn.
English: Patients aged 2 to 5 years and weighing 14 kg or greater lumacaftor 150 mg/ivacaftor 188 mg sachet every 12 hours
Maltese: Pazjenti li kellhom sentejn sa 5 snin u jiżnu 14-il kg jew iktar qartas lumacaftor 150 mg/ivacaftor 188 mg kull 12-il siegħa
English: Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Maltese: Kull pillola fiha 100 mg ta' lumacaftor u 125 mg ta' ivacaftor.
English: The exposure (AUC) of lumacaftor is approximately 2-fold higher in healthy adult volunteers compared to exposure in patients with CF.
Maltese: L-esponiment ta' ivacaftor hu simili bejn voluntiera adulti b'saħħithom u pazjenti b'CF.
English: Safety data were evaluated in 60 patients aged 2 to 5 years, 161 patients aged 6 to 11 years (Trials 6, 7, and 8) and in 194 patients aged 12 to 17 years with CF who are homozygous for the F508del mutation and who received lumacaftor/ivacaftor in clinical studies.
Maltese: Dejta dwar is-sigurtà evalwat f'60 pazjent li kellhom minn 2 sa 5 snin, 161 pazjent li kellhom minn 6 sa 11-il sena (Provi 6, 7, u 8) u f'194 pazjent li kellhom bejn 12 u 17-il sena b'CF, li kienu homozygous għall-mutazzjoni F508del u li kienu rċivew lumacaftor/ivacaftor fl-istudji kliniċi.
English: However, when initiating Orkambi in patients taking strong CYP3A inhibitors, the dose should be reduced to one sachet (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 2 to 5 years and weighing less than 14 kg; lumacaftor 150 mg/ivacaftor 188 mg for patients aged 2 to 5 years and weighing 14 kg or greater) every other day for the first week of treatment to allow for the steady state induction effect of lumacaftor.
Maltese: Madankollu, meta jinbeda Orkambi f'pazjenti li jkunu qed jieħdu inibituri qawwija ta' CYP3A, id-doża għandha titnaqqas għal qartas wieħed (lumacaftor 100 mg/ivacaftor 125 mg għal pazjenti li jkollhom minn sentejn sa 5 snin u jiżnu inqas minn 14-il kg; lumacaftor 150 mg/ivacaftor 188 mg għal pazjenti li jkollhom bejn sentejn u 5 snin u jiżnu 14-il kg jew iktar) darba iva u darba le għall-ewwel ġimgħa ta' kura, biex jiġi kkunsidrat l-effett ta' induzzjoni fl-istat fiss ta' lumacaftor.
English: After oral administration of 400 mg every 12 hours in patients with CF in a fed state, the typical apparent volumes of distribution for the central and peripheral compartments (CV) were estimated to be 23.5 L (48.7%) and 33.3 L (30.5%), respectively.
Maltese: [koeffiċjent ta' varjazzjoni bħala perċentwali (CV)] kienu stmati li huma 23.5 L (48.7%) u 33.3 L (30.
English: Therefore, concomitant use of lumacaftor/ivacaftor with CYP3A substrates may decrease the exposure of these substrates (see section 4.4).
Maltese: Għalhekk, l-użu fl-istess ħin ta' lumacaftor/ivacaftor ma' substrati ta' CYP3A, jista' jnaqqas l-esponiment ta' dawn is-substrati (ara sezzjoni 4.4).
English: Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
Maltese: Kull pillola fiha 200 mg ta' lumacaftor u 125 mg ta' ivacaftor.
English: Following oral administration of lumacaftor, the majority of lumacaftor (51%) is excreted unchanged in the faeces.
Maltese: Wara l-għoti orali ta' lumacaftor, il-maġġoranza ta' lumacaftor (51%) jitneħħa mhux mibdul flippurgar.
English: • Anti-allergic medicines (used for the treatment of allergies and/or asthma) for example: montelukast, fexofenadine
Maltese: • Mediċini kontra l-allerġiji (jintużaw għall-kura ta' allerġiji u/jew ażżma) pereżempju: montelukast, fexofenadine
English: For patients aged 2 to 5 years and < 14 kg lumacaftor 200 mg + ivacaftor 250 mg
Maltese: Għal pazjenti li għandhom minn sentejn sa 5 snin u jiżnu < 14-il kg lumacaftor 200 mg + ivacaftor 250 mg
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg film-coated tablets Orkambi 200 mg/125 mg film-coated tablets
Maltese: Orkambi 100 mg/125 mg pilloli miksija b'rita Orkambi 200 mg/125 mg pilloli miksija b'rita
English: After oral administration of ivacaftor 250 mg every 12 hours in combination with lumacaftor, the typical apparent volumes of distribution for the central and peripheral compartments [coefficient of variation as a percentage (CV)] were estimated to be 95.0 L (53.9%) and 201 L (26.6%), respectively.
Maltese: Wara għoti orali ta' ivacaftor 250 mg kull 12-il siegħa flimkien ma' lumacaftor, ilvolumi apparenti tipiċi tad-distribuzzjoni għall-kompartimenti ċentrali u periferali (CV) kienu stmati li huma 95.0
English: The treatment difference (LS mean) in sweat chloride for the average absolute change at Day 15 and at Week 4 as compared to placebo was -20.8 mmol/L (95% CI: -23.4, -18.2; nominal P < 0.0001).
Maltese: 8 mmol/L (95% CI: -23.4, -18.2; P nominali < 0.0001).
English: There is potential for other medicinal products to affect lumacaftor/ivacaftor when administered concomitantly, and also for lumacaftor/ivacaftor to affect other medicinal products.
Maltese: Hemm il-potenzjal għal prodotti mediċinali oħrajn li jaffettwaw lumacaftor/ivacaftor meta jingħataw fl-istess ħin, u wkoll għal lumacaftor/ivacaftor li jaffettwa prodotti mediċinali oħrajn.
English: The event occurred within 5 days of the start of dosing and resolved following discontinuation of lumacaftor/ivacaftor (see section 4.4).
Maltese: Lavveniment seħħ fi żmien 5 ijiem mill-bidu tad-dożaġġ u fieq wara t-twaqqif ta' lumacaftor/ivacaftor (ara sezzjoni 4.4).
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 200 mg ta' lumacaftor u 125 mg ta' ivacaftor.
English: The absolute change from predose at 4-6 hours post-dose was -7.7 on Day 1 and -1.3 on Day 15 in lumacaftor/ivacaftor patients.
Maltese: Il-bida assoluta minn qabel id-doża 4 sa 6 sigħat wara doża kienet ta' -7.7 f'Jum 1 u -1.3 f'Jum 15 fil-pazjenti li kienu fuq lumacaftor/ivacaftor.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/003 28 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1059/003 28 pillola miksija b'rita
English: The treatment difference in this subgroup was comparable to that observed in patients with ppFEV1 ≥ 40.
Maltese: Id-differenza fil-kura f'dan is-sottogrupp kienet komparabbli ma' dik osservata f'pazjenti b'ppFEV1 ta' ≥40.
English: Patients aged 2 to 5 years and weighing and less than 14 kg lumacaftor 100 mg/ivacaftor 125 mg sachet every 12 hours
Maltese: Pazjenti li kellhom minn sentejn u 5 snin u jiżnu inqas minn 14 kg qartas lumacaftor 100 mg/ivacaftor 125 mg kull 12-il siegħa
English: LUM 200 mg/IVA 250 mg q12h (n = 103)
Maltese: 250 mg q12h (n=103)
English: Studies have not been conducted in patients with severe hepatic impairment (Child-Pugh Class C, score 10 to 15), but exposure is expected to be higher than in patients with moderate hepatic impairment (see sections 4.2, 4.4, and 4.8).
Maltese: Ma sarux studji f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh Klassi Ċ, punteġġ minn 10 sa 15), iżda l-esponiment hu mistenni li jkun ogħla milli f'pazjenti b'indeboliment moderat tal-fwied (ara sezzjonijiet 4.2, 4.4, u 4.8).
English: Orkambi 150 mg/188 mg granules in sachet are white to off-white granules.
Maltese: Orkambi 150 mg/188 mg granijiet f'qartas huma granijiet ta' lewn abjad sa abjad jagħti fil-griż.
English: Adverse events that occurred at an increased incidence of ≥ 5% in the supratherapeutic dose period compared with the therapeutic dose period were headache, generalised rash, and increased transaminase.
Maltese: Avvenimenti avversi li seħħew f'inċidenza miżjuda ta' ≥5% fil-perjodu tad-doża supraterapewtika mqabbla mal-perjodu tad-doża terapewtika kienu wġigħ ta' ras, raxx ġeneralizzat, u żieda fittransaminases.
English: • Multipacks containing 112 film-coated tablets (4 packs of 28 film-coated tablets).
Maltese: • Pakkett multipli li fihom 112-il pillola miksija b'rita (4 pakketti ta' 28 pillola miksija b'rita).
English: Table 2: Dose adjustment recommendations for patients with hepatic impairment Hepatic impairment
Maltese: Tabella 2: Rakkomandazzjonijiet għal aġġustament fid-doża għal pazjenti b'indeboliment talfwied
English: Co-administration of Orkambi with medicinal products that inhibit BCRP may increase plasma lumacaftor concentration.
Maltese: Il-pazjenti kollha kellhom insuffiċjenza pankreatika fil-linja bażi.
English: Table 4: Adverse reactions in lumacaftor/ivacaftor-treated patients and in patients treated with ivacaftor alone
Maltese: Tabella 4: Reazzjonijiet avversi f'pazjenti kkurati b'lumacaftor/ivacaftor u f'pazjenti ikkurati b'ivacaftor waħdu
English: Orkambi 200 mg/125 mg film-coated tablets:
Maltese: Orkambi 200 mg/125 mg pilloli miksija b'rita:
English: During Trials 1 and 2, adverse reactions related to increased blood pressure (e.g., hypertension, blood pressure increased) were reported in 0.9% (7/738) of patients treated with lumacaftor/ivacaftor and in no patients who received placebo.
Maltese: Matul Provi 1 u 2, reazzjonijiet avversi relatati ma' żieda fil-pressjoni tad-demm (eż., pressjoni għolja, żieda fil-pressjoni tad-demm) ġew irrappurtati f'0.9% (7/738) tal-pazjenti kkurati b'lumacaftor/ivacaftor u fl-ebda pazjent li rċieva l-plaċebo.
English: 2 tablets in the morning 2 tablets in the evening
Maltese: 2 pilloli filgħodu 2 pilloli filgħaxija
English: For patients aged 12 years and older 800 mg lumacaftor + 500 mg ivacaftor
Maltese: 800 mg lumacaftor + 500 mg ivacaftor
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Orkambi 100 mg/125 mg film-coated tablets Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Maltese: Orkambi 100 mg/125 mg granijiet f'qartas Kull qartas fih 100 mg ta' lumacaftor u 125 mg ta' ivacaftor.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1059/006
English: In addition, the mean absolute change in sweat chloride from Week 24 at Week 26 following the 2-week washout period (to evaluate off-drug response) was an increase of 33.0 mmol/L (95% CI: 28.9, 37.1; nominal P < 0.0001), representing a return to baseline after treatment washout.
Maltese: Barra minn hekk, il-bidla assoluta medja ta' chloride fl-għaraq minn Ġimgħa 24 f'Ġimgħa 26 wara l-perjodu ta' ġimagħtejn ta' washout) (biex jiġi evalwat ir-rispons mingħajr il-mediċina) kienet żieda ta' 33.0 mmol/L (95% CI: 28.9, 37.1; P nominali < 0.0001), li tirrappreżenta ritorn għal-linja bażi wara l-washout tat-trattament.
English: Multipacks containing 56 film-coated tablets (2 packs of 28 film-coated tablets).
Maltese: Pakkett multipli li fihom 56 pillola miksija b'rita (2 pakketti ta' 28 pillola miksija b'rita).
English: If Orkambi is interrupted for more than one week and then re-initiated while taking strong CYP3A inhibitors, the Orkambi dose should be reduced to one tablet daily (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 6 to 11 years; lumacaftor 200 mg/ivacaftor 125 mg for patients aged 12 years and older) for the first week of treatment re-initiation.
Maltese: Jekk Orkambi jitwaqqaf għal aktar minn ġimgħa u mbagħad jerġa' jinbeda waqt li jkunu qed jittieħdu inibituri qawwija ta' CYP3A, id-doża ta' Orkambi għandha titnaqqas għal pillola waħda kuljum (lumacaftor 100 mg/ivacaftor 125 mg għal pazjenti li jkollhom minn 6 sa 11-il sena; lumacaftor 200 mg/ivacaftor 125 mg għal pazjenti li jkollhom 12-il sena u aktar) għall-ewwel ġimgħa tal-bidu mill-ġdid tal-kura.
English: False Positive Urine Tests for THC
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: ketoconazole, voriconazole Due to induction of CYP3A by LUM
Maltese: ↓ itraconazole, ketoconazole, voriconazole Minħabba linduzzjoni ta' CYP3A minn LUM
English: NAME OF THE MEDICINAL PRODUCT Orkambi 200 mg/125 mg tablets lumacaftor/ivacaftor
Maltese: Orkambi 200 mg/125 mg pilloli miksija b'rita lumacaftor/ivacaftor
English: • H2 Antagonist medicines (used to reduce stomach acid) for example: ranitidine
Maltese: • Mediċini antagonisti ta' H2 (jintużaw biex inaqqsu l-aċidu fl-istonku) pereżempju:
English: Flatulence, vomiting
Maltese: Gass, rimettar