FrancophonIA/ELRC3.0 huggingface dataset:
English: Orkambi 200 mg/125 mg film-coated tablets (tablets) are pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed with “2V125” in black ink on one side.
Maltese: Orkambi 200 mg/125 mg pilloli miksija b'rita (pilloli) huma pilloli roża, b'forma ovali (daqs 14 × 8.4 × 6.8 mm) stampati b'“2V125” b'linka sewda fuq naħa waħda.
English: * Based on clinical drug-drug interaction studies.
Maltese: * Ibbażati fuq studji dwar interazzjonijiet bejn mediċina u oħra.
English: • Proton pump inhibitor medicines (used to treat acid reflux disease and ulcers): omeprazole, esomeprazole, lansoprazole
Maltese: • Mediċini inibituri tal-pompa tal-protons (jintużaw għall-kura tal-marda tar-rifluss tal-aċidu u ulċeri): omeprazole, esomeprazole, lansoprazole
English: Marketing Authorisation Holder Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper Dublin 2, D02 EK84
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper
English: Relative change in ppFEV1 at Week 24 (%)
Maltese: Bidla relattiva f'ppFEV1 f'Ġimgħa 24 (%)
English: • Irregular periods (menses) or pain with menses
Maltese: • Periods (mestrwazzjoni) irregolari jew uġigħ waqt il-periods
English: • Chest tightness
Maltese: • Dardir jew rimettar
English: Week 24 as compared to placebo was -24.9 mmol/L (nominal P < 0.0001).
Maltese: 9 mmol/L (P nominali < 0.0001).
English: Lumacaftor/ivacaftor may decrease the exposure of hormonal contraceptives, which may reduce their efficacy.
Maltese: Lumacaftor/ivacaftor jista' jnaqqas l-esponimenti ta' kontraċettivi ormonali, li jista' jnaqqas l-effikaċja tagħhom.
English: The most common adverse reactions experienced by patients aged 12 years and older who received lumacaftor/ivacaftor in the pooled, placebo-controlled, Phase 3 studies were dyspnoea (14.0% versus 7.8% on placebo), diarrhoea (11.0% versus 8.4% on placebo), and nausea (10.2% versus 7.6% on placebo).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni li kellhom pazjenti ta' 12-il sena jew aktar, li rċivew lumacaftor/ivacaftor fl-istudji miġbura ta' Fażi 3, ikkontrollati bi plaċebo, kienu qtugħ ta' nifs (14.0% kontra 7.8% bil-plaċebo), dijarea (11.0% kontra 8.4% bil-plaċebo), u dardir (10.2% kontra 7.6% bilplaċebo).
English: Mild hepatic impairment (Child-Pugh Class A)
Maltese: Indeboliment ħafif talfwied (Child-Pugh Klassi A)
English: ↔ LUM, IVA ↑ or ↓ warfarin
Maltese: L-iżvilupp ta' qabel u wara t-twelid
English: The treatment difference between the combination of lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo evaluated as mean change in sweat chloride from baseline to Day 56 was statistically significant at -11 mmol/L (95% CI: -18, -4).
Maltese: Id-differenza fil-kura bejn il-kombinazzjoni ta' lumacaftor 400 mg/ivacaftor 250 mg q12h u plaċebo evalwata bħala l-bidla medja tal-chloride flgħaraq mil-linja bażi sa Jum 56, kienet statistikament sinifikanti f'ammont ta' -11 mmol/L (95% CI: -18, -4).
English: PHARMACEUTICAL FORM AND CONTENTS 112 film-coated tablets (4 packs of 28 tablets) 56 film-coated tablets (2 packs of 28 tablets)
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 112-il pillola miksija b'rita (4 pakketti ta' 28 pillola) 56 pillola miksija b'rita (2 pakketti ta' 28 pillola)
English: Important information about the contents of Orkambi This medicine contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: How to take Orkambi
Maltese: Doża ta' Orkambi
English: Trial 1 evaluated 549 patients with CF who were aged 12 years and older (mean age 25.1 years) with percent predicted FEV1 (ppFEV1) at screening between 40-90 (mean ppFEV1 60.7 at baseline [range: 31.1 to 94.0]).
Maltese: Prova 1 evalwat 549 pazjent b'CF li kellhom 12-il sena u aktar (età medja 25.1 sena) b'perċentwali ta' FEV1 mbassar (ppFEV1) waqt l-iscreening ta' bejn 40-90 (medja ta' ppFEV1 ta' 60.7 fil-linja bażi [medda: 31.1 sa 94.0]).
English: Baseline BMI (kg/m2)‡ Absolute change from baseline in BMI (kg/m2)
Maltese: BMI fil-Linja bażi (kg/m2)‡ 20.9 (2.8) Bidla medja assoluta mil-linja bażi fil-BMI (kg/m2)
English: Co-administration of Orkambi with medicinal products that are substrates for OAT1/3 and BCRP transport may increase plasma concentrations of such medicinal products.
Maltese: L-għoti flimkien ta' Orkambi ma' prodotti mediċinali li huma substrati għal OAT1/3 u BCRP tat-trasport, jista' jżid ilkonċentrazzjonijiet ta' dawn il-prodotti mediċinali fil-plażma.
English: The other ingredients are: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; povidone (K30); and sodium laurilsulfate.
Maltese: • Qalba tal-pillola: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; povidone (K30); sodium laurilsulfate; u magnesium stearate
English: The efficacy of lumacaftor/ivacaftor in patients with CF who are homozygous for the F508del mutation in the CFTR gene was evaluated in two randomised, double-blind, placebo-controlled clinical trials of 1108 clinically stable patients with CF, in which 737 patients were randomised to and dosed with lumacaftor/ivacaftor.
Maltese: L-effikaċja ta' lumacaftor/ivacaftor f'pazjenti b'CF li huma homozygous għall-mutazzjoni F508del fil-ġene CFTR ġiet evalwata f'żewġ provi kliniċi li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo, li saru fuq 1108 pazjenti klinikament stabbli b'CF, li fihom 737 pazjent intgħażlu b'mod każwali għal, u ngħataw dożaġġ ta' lumacaftor/ivacaftor.
English: Orkambi 200 mg/125 mg film-coated tablets
Maltese: Orkambi 200 mg/125 mg pilloli
English: In the pooled analysis, the rate ratio of exacerbations through week 24 in subjects treated with lumacaftor/ivacaftor (lumacaftor 400 mg/ivacaftor 250 mg q12h; n = 369) was 0.61 (P < 0.0001), representing a reduction of 39% relative to placebo.
Maltese: Fl-analiżi miġbura, il-proporzjon tar-rata ta' aggravamenti sa ġimgħa 24 f'individwi kkurati b'lumacaftor/ivacaftor (lumacaftor 400 mg/ivacaftor 250 mg q12h; n=369) kien ta' 0.61 (P < 0.0001), kien 0.61, li jirrappreżenta tnaqqis ta' 39% meta mqabbel mal-plaċebo.
English: Patients received either lumacaftor/ivacaftor (n = 62) or placebo (n = 63) in addition to their prescribed CF therapies.
Maltese: Il-pazjenti rċivew jew lumacaftor/ivacaftor (n=62) jew plaċebo (n=63) flimkien mat-terapiji preskritti tagħhom għal CF.
English: Of the 1108 patients who received any treatment in Trial 1 or Trial 2, 1029 (93%) were dosed and received active treatment (lumacaftor 600 mg once daily/ivacaftor 250 mg q12h or lumacaftor 400 mg q12h/ivacaftor 250 mg q12h) in Trial 3 for up to an additional 96 weeks (i.e. up to a total of 120 weeks).
Maltese: Mill-1108 pazjent li rċivew kwalunkwe kura fi Prova 1 jew Prova 2, 1029 (93%) ingħataw doża u rċivew kura attiva (lumacaftor 600 mg darba kuljum/ivacaftor 250 mg q12h jew lumacaftor 400 mg q12h/ivacaftor 250 mg q12h) fi Prova 3 għal sa 96 Ġimgħa addizzjonali (i.e. sa total ta' 120 Ġimgħa).
English: The median (range) tmax of lumacaftor is approximately 4.0 hours (2.0; 9.0) in the fed state.
Maltese: Il-medjan (medda) tat-tmax ta' lumacaftor hu ta' madwar 4.0 sigħat (2.0; 9.0) wara li wieħed ikun kiel.
English: Trial 7 was a 24-week, placebo-controlled, Phase 3 clinical study in 204 patients with CF aged 6 to 11 years old (mean age 8.8 years).
Maltese: Prova 7 kienet studju kliniku ta' Fażi 3 li dam 24 ġimgħa, ikkontrollat bi plaċebo, li sar fuq 204 pazjent b'CF, li kellhom minn 6 sa 11-il sena (età medja ta' 8.8 snin).
English: Absolute change from baseline in stature-for-age z-score n = 57 95% CI: 0.02, 0.15; P = 0.0104
Maltese: Bidla assoluta mil-linja bażi fil-punteġġ statura għal età z n = 57 95% CI: 0.02, 0.15; P = 0.0104
English: Post-Authorization Safety Study (PASS) The applicant should conduct a 5-year long-term observational study with lumacaftor/ivacaftor in patients with cystic fibrosis, including also microbiological and clinical endpoints (e.g. exacerbations) according to an approved protocol.
Maltese: L-applikant għandu jwettaq studju ta' osservazzjoni ta' 5 snin b'lumacaftor/ivacaftor f'pazjenti b'fibrożi ċistika, li jinkludi wkoll punti aħħarin mikrobijoloġiċi u kliniċi (eż. aggravamenti), skont protokoll approvat.
English: Patients with CF who are heterozygous for the F508del mutation in the CFTR gene Lumacaftor/ivacaftor is not effective in patients with CF who have the F508del mutation on one allele plus a second allele with a mutation predicted to result in a lack of CFTR production or that is not responsive to ivacaftor in vitro (see section 5.1).
Maltese: Pazjenti b'CF li huma heterozygous għall-mutazzjoni F508del fil-ġene CFTR Lumacaftor/ivacaftor mhuwiex effettiv f'pazjenti b'CF li jkollhom il-mutazzjoni F508del fuq allele waħda flimkien mat-tieni allele b'mutazzjoni li tkun imbassra li tirriżulta f'nuqqas ta' produzzjoni ta' CFTR jew li ma tirrispondix għal ivacaftor in vitro (ara sezzjoni 5.1).
English: Trials in patients with CF aged 6 to 11 years old who are homozygous for the F508del mutation in the CFTR gene
Maltese: Provi f'pazjenti b'CF li kellhom minn 6 sa 11-il sena u li kienu homozygous għall-mutazzjoni F508del fil-ġene CFTR
English: In patients treated with lumacaftor/ivacaftor (mean baseline 114 mmHg systolic and 69 mmHg diastolic), the maximum increase from baseline in mean systolic and diastolic blood pressure was 3.1 mmHg and 1.8 mmHg, respectively.
Maltese: F'pazjenti kkurati b'lumacaftor/ivacaftor (medja tal-pressjoni sistolika ta' 114 mmHg u medja talpressjoni dijastolika ta' 69 mmHg fil-linja bażi), iż-żieda massima mil-linja bażi tal-medja talpressjoni sistolika u tal-medja tal-pressjoni dijastolika tad-demm kienet ta' 3.1 mmHg u 1.8 mmHg, rispettivament.
English: Proportion of patients with ≥5% relative change in ppFEV1 at Week 24
Maltese: Proporzjon ta' pazjenti b'bidla relattiva ta' ≥5% f'ppFEV1 f'Ġimgħa 24
English: Trial 3 was a Phase 3, parallel-group, multicentre, rollover extension study in patients with CF that included patients aged 12 years and older from Trial 1 and Trial 2.
Maltese: Prova 3 kien studju ta' estensjoni rollover ta' Fażi 3, grupp parallel, multiċentriku, li sar f'pazjenti b'CF li kienu jinkludu pazjenti li kellhom 12-il sena u aktar minn Prova 1 u Prova 2.
English: The event rate per year, annualised to 48 weeks, was 0.70 in the lumacaftor/ivacaftor group and 1.14 in the placebo group.
Maltese: Ir-rata ta' avvenimenti kull sena, annwalizzata sa 48 ġimgħa, kienet ta' 0.70 fil-grupp ta' lumacaftor/ivacaftor u 1.14 fil-grupp talplaċebo.
English: The exposures are similar between adults and the paediatric population based on population (PK) analyses as presented in Table 8 below:
Maltese: L-esponimenti huma simili bejn l-adulti u l-popolazzjoni pedjatrika bbażat fuq analiżijiet talpopolazzjoni (PK) kif ippreżentati f'Tabella 8 hawn taħt:
English: The treatment difference between lumacaftor 400 mg q12h alone and placebo evaluated as mean change in sweat chloride from baseline to Day 28 was statistically significant at -8.2 mmol/L (95% CI: -14, -2).
Maltese: Id-differenza fil-kura bejn lumacaftor 400 mg q12h waħdu u plaċebo evalwata bħala l-bidla medja tal-chloride fl-għaraq mil-linja bażi sa Jum 28, kienet statistikament sinifikanti f'ammont ta' -8.2 mmol/L (95% CI: -14, -2).
English: • Anti-inflammatory medicines (used for the treatment of inflammation) for example: ibuprofen
Maltese: • Mediċini kontra l-infjammazzjoni (jintużw għall-kura ta' infjammazzjoni) pereżempju: ibuprofen
English: Ear pain*, ear discomfort*, tinnitus*, tympanic membrane hyperaemia*, vestibular disorder* uncommon Ear congestion*
Maltese: Uġigħ fil-widnejn*, skonfort fil-widnejn*, tinnitus*, iperimija fil-membrana timpanika*, disturb vestibulari*
English: Therefore, concomitant use of lumacaftor/ivacaftor may alter (i.e., either increase or decrease) the exposure of CYP2C8 and CYP2C9 substrates, decrease the exposure of CYP2C19 substrates, and substantially decrease the exposure of CYP2B6 substrates.
Maltese: Għalhekk, l-użu fl-istess ħin ta' lumacaftor/ivacaftor jista' jibdel (i.e., jew żieda jew tnaqqis) l-esponiment ta' substrati ta' CYP2C8 u CYP2C9, inaqqas l-esponiment ta' substrati ta' CYP2C19 u jnaqqas sostanzjalment l-esponiment ta' substrati ta' CYP2B6.
English: During the 24-week, open-label Phase 3 clinical study in 60 patients aged 2 through 5 years (Trial 8), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and > 3 x ULN was 8.3% (5/60), 11.7% (7/60), and 15.0% (9/60).
Maltese: Matul l-istudju kliniku ta' Fażi 3 li dam 24‑ġim għa, open -label, li sar fuq 60 pazjent li kellhom minn sentejn sa 5 snin (Prova 8), l-inċidenza ta' livelli massimi ta' transaminases (ALT jew AST) ta' > 8, > 5, u > 3 x ULN kienet ta' 8.3% (5/60), 11.7% (7/60), u 15.
English: Trial in patients with CF who are heterozygous for the F508del mutation in the CFTR gene Trial 4 was a multicentre, double-blind, randomised, placebo-controlled, Phase 2 trial in 125 patients with CF aged 18 years and older who had a ppFEV1 of 40 to 90, inclusive, and have the F508del mutation on one allele plus a second allele with a mutation predicted to result in the lack of CFTR production or a CFTR that is not responsive to ivacaftor in vitro.
Maltese: Prova f'pazjenti b'CF li kienu heterozygous għall-mutazzjoni F508del fil-ġene CFTR Prova 4 kienet prova ta' Fażi 2, multiċentrika, double-blind, li fiha l-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo, li saret fuq 125 pazjenti b'CF li kellhom 18-il sena jew aktar, li kellhom ppFEV1 ta' 40 - 90, inklużi, u li kellhom il-mutazzjoni F508del fuq allele waħda flimkien mat-tieni allele b'mutazzjoni li kienet imbassra li se tirriżulta fin-nuqqas ta' produzzjoni ta' CFTR jew CFTR li ma tirrispondix għal ivacaftor in vitro.
English: After oral administration of lumacaftor 400 mg q12h/ivacaftor 250 mg q12h in a fed state, the steady-state mean (± SD) for AUC0-12h and Cmax were 198 (64.8) µg∙hr/mL and 25.0 (7.96) µg/mL for lumacaftor, respectively, and 3.66 (2.25) µg∙hr/mL and 0.602 (0.304) µg/mL for ivacaftor, respectively.
Maltese: Wara l-għoti orali ta' lumacaftor 400 mg q12h/ivacaftor 250 mg q12h wara li wieħed ikun kiel, il-medja l-istat fiss (±SD) għall-AUC0-12h u s-Cmax kienet ta' 198 (64.8) g∙hr/mL u 25.
English: Doses above 100 mg/kg/day resulted in survival and lactation indices that were 92% and 98% of control values, respectively, as well as reductions in pup body weights.
Maltese: Dożaġġi ta' aktar minn 100 mg/kg/jum irriżultaw f'indiċijiet tas-sopravivenza u tat-treddigħ li kienu 92% u 98% tal-valuri ta' kontroll, rispettivament, kif ukoll tnaqqis fil-piżijiet tal-ġisem tal-frieħ.
English: Orkambi dose
Maltese: Użu orali
English: ↓ ethinyl estradiol, norethindrone, and other progestogens Due to induction of CYP3A/UGT by LUM
Maltese: ↓ ethinyl estradiol, norethindrone, u progestogens oħrajn Minħabba linduzzjoni ta' CYP3A/UGT minn LUM
English: ANNEX II
Maltese: Tabella 2:
English: 6 years and older
Maltese: 6 snin u iżjed
English: Results indicate no clinically relevant difference in pharmacokinetic parameters for lumacaftor or ivacaftor between males and females.
Maltese: Ir-riżultati ma jindikaw l-ebda differenza klinikament rilevanti fil-parametri farmakokinetiċi għal lumacaftor jew ivacaftor bejn irġiel u nisa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/001 112 film-coated tablets EU/1/15/1059/002 56 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1059/001 112-il pillola miksija b'rita EU/1/15/1059/002 56 pillola miksija b'rita
English: Due to inhibition of CYP3A by clarithromycin, telithromycin
Maltese: Minħabba linibizzjoni ta' CYP3A minn clarithromycin, telithromycin
English: Treatment with lumacaftor/ivacaftor significantly decreased the risk for exacerbations requiring hospitalisation versus placebo by 61% (rate ratio = 0.39, P < 0.0001; event rate per 48 weeks 0.17 for lumacaftor/ivacaftor and 0.45 for placebo) and reduced exacerbations requiring treatment with intravenous antibiotics by 56% (rate ratio = 0.44, P < 0.0001; event rate per 48 weeks 0.25 for lumacaftor/ivacaftor and 0.58 for placebo).
Maltese: Il-kura b'lumacaftor/ivacaftor naqqset b'mod sinifikanti r-riskju għal aggravamenti li kienu jeħtieġu kura fl-isptar, kontra l-plaċebo b'61% (proporzjon tar-rata=0.39, P<0.0001; rata ta' avvenimenti kull 48 ġimgħa ta' 0.17 għal lumacaftor/ivacaftor u 0.45 għal plaċebo) u naqqset laggravamenti li kienu jeħtieġu kura b'antibijotiċi ġol-vini minn 56% (proporzjon tar-rata=0.44, P<0.0001; rata ta' każijiet kull 48 ġimgħa ta' 0.25 għal lumacaftor/ivacaftor u 0.58 għal plaċebo).
English: Treatment with lumacaftor/ivacaftor significantly decreased the risk for exacerbations requiring hospitalisation versus placebo by 61% (rate ratio=0.39, P < 0.0001; event rate per 48 weeks 0.17 for lumacaftor/ivacaftor and 0.45 for placebo) and reduced exacerbations requiring treatment with intravenous antibiotics by 56% (rate ratio = 0.44, P < 0.0001; event rate per 48 weeks 0.25 for lumacaftor/ivacaftor and 0.58 for placebo).
Maltese: Il-kura b'lumacaftor/ivacaftor naqqset b'mod sinifikanti r-riskju għal aggravamenti li kienu jeħtieġu kura fl-isptar, kontra l-plaċebo b'61% (proporzjon tar-rata=0.39, P < 0.0001; rata ta' avvenimenti kull 48 ġimgħa ta' 0.17 għal lumacaftor/ivacaftor u 0.45 għal plaċebo) u naqqset laggravamenti li kienu jeħtieġu kura b'antibijotiċi ġol-vini minn 56% (proporzjon tar-rata = 0.44, P < 0.0001; rata ta' każijiet kull 48 ġimgħa ta' 0.25 għal lumacaftor/ivacaftor u 0.58 għal plaċebo).
English: What Orkambi looks like and contents of the pack Orkambi 100 mg/125 mg film-coated tablets (tablets) are pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed with “1V125” in black ink on one side.
Maltese: Kif jidher Orkambi u l-kontenut tal-pakkett Orkambi 100 mg/125 mg pilloli miksija b'rita (pilloli) huma pilloli roża, b'forma ovali (daqs 14 × 7.6 × 4.9 mm) stampati b'“1V125” b'linka sewda fuq naħa waħda.
English: For patients with moderate hepatic impairment (Child-Pugh Class B), a dose reduction is recommended.
Maltese: Għal pazjenti b'indeboliment moderat tal-fwied (Child-Pugh Klassi B), tnaqqis fid-doża hi rakkomandata.
English: Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene (see sections 4.2, 4.4 and 5.1).
Maltese: Il-pilloli ta' Orkambi huma indikati għall-kura ta' fibrożi ċistika (CF) f'pazjenti li jkollhom 6 snin u aktar u li jkunu homozygous għall-mutazzjoni F508del fil-ġene CFTR (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: At Week 24, 16% of children had a reduction in sweat chloride below 60 mmol/L, and none below 30 mmol/L.
Maltese: F'ġimgħa 24, 16% tat-tfal kellhom tnaqqis fil-chloride fl-għaraq għal inqas minn 60 mmol/L, u ħadd taħt 30 mmol/L.
English: Lumacaftor/ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Maltese: Lumacaftor/ivacaftor ma ġiex studjat f'pazjenti b'CF li kellhom trapjant tal-organi.
English: † Indicates statistical significance confirmed in the hierarchical testing procedure.
Maltese: †Jindika sinifikanza statistika kkonfermata fil-proċedura ta' ttestjar ġerarkiku.
English: In Trial 7 (see Clinical efficacy and safety) in patients homozygous for the F508del-CFTR mutation aged 6 to 11 years, the treatment difference (LS mean) in sweat chloride for the absolute change at
Maltese: Fi Prova 7 (ara Effikaċja klinika u sigurtà) f'pazjenti homozygous għall-mutazzjoni F508del-CFTR li kellhom bejn 6 u 11-il sena, id-differenza fil-kura (medja LS) tal-chloride tal-għaraq għall-bidla assoluta f'Ġimgħa 24 meta mqabbla mal-plaċebo kienet ta' -24.
English: No meaningful changes in QTc interval or blood pressure were observed in a thorough QT clinical study evaluating either lumacaftor 600 mg once daily/ivacaftor 250 mg q12h or lumacaftor 1000 mg once daily/ivacaftor 450 mg q12h, demonstrating a lack of translation of these non-clinical findings to the clinic.
Maltese: L-ebda tibdiliet sinifikanti fl-intervall tal-QTc jew fil-pressjoni tad-demm ma ġew osservati fi studju kliniku bir-reqqa dwar il-QT, li evalwa jew lumacaftor 600 mg darba kuljum/ivacaftor 250 mg q12h jew lumacaftor 1000 mg darba kuljum/ivacaftor 450 mg q12h, u dan juri nuqqas ta' traduzzjoni ta' dawn is-sejbiet mhux kliniċi lill-klinika.
English: Ivacaftor impaired fertility and reproductive performance indices in male and female rats at 200 mg/kg/day (yielding exposures approximately 11 and 7 times, respectively, those obtained with the maximum recommended human dose of the ivacaftor component of Orkambi based on summed AUCs of ivacaftor and its metabolites extrapolated from Day 90 exposures at 150 mg/kg/day in the 6-month repeat-dose toxicity study and gestation Day 17 exposures in the pilot embryofoetal development study in this species) when dams were dosed prior to and during early pregnancy.
Maltese: Ivacaftor indebbolixxa l-fertilità u indiċijiet tal-prestazzjoni riproduttiva f'firien irġiel u nisa f'doża ta' 200 mg/kg/jum (li jagħtu esponimenti ta' bejn wieħed u ieħor 11 u 7 darbiet, rispettivament, ta' dawk miksuba bid-doża massima rakkomandata fil-bniedem tal-komponent ivacaftor ta' Orkambi, ibbażat fuq it-total tal-AUCs ta' ivacaftor u l-metaboliti tiegħu estrapolati mill-esponimenti ta' Jum 90 f'doża ta' 150 mg/kg/jum fi studju li dam 6 xhur dwar tossiċità minn dożi ripetuti u l-esponimenti f'Jum 17 tal-ġestazzjoni fl-istudju pilota dwar l-iżvilupp embrijufetalif'din l-ispeċi) meta l-ommijiet ingħataw doża qabel it-tqala u fil-perjodu bikri tat-tqala.Ma ġew osservati l-ebda effetti fuq l-indiċijiet talfertilità u l-prestazzjoni riproduttiva tal-irġiel jew tan-nisa f'doża ta' ≤100 mg/kg/jum (li jagħtu esponimenti ta' bejn wieħed u ieħor 8 u 5 darbiet, rispettivament, ta' dawk miksuba bid-doża massima rakkomandata fil-bniedem tal-komponent ivacaftor ta' Orkambi, ibbażat fuq it-total tal-AUCs ta' ivacaftor u l-metaboliti tiegħu estrapolati mill-esponimenti ta' Jum 90 f'doża ta' 100 mg/kg/jum flistudju li dam 6 xhur dwar tossiċità minn dożi ripetuti u l-esponimenti f'Jum 17 tal-ġestazzjoni fl-istudju dwar l-iżvilupp embrijufetali f'din l-ispeċi).
English: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC - an active component in cannabis) in patients receiving Orkambi.
Maltese: Kien hemm rapporti ta' testijiet tal-iskrining tal-awrina b'riżultati pożittivi foloz għal tetrahydrocannabinol (THC - komponent attiv fil-kannabis) f'pazjenti li kienu qed jirċievu Orkambi.
English: Other medicines and Orkambi
Maltese: Mediċini oħra u Orkambi
English: Concomitant medicinal products of most clinical relevance Anti-allergics: montelukast
Maltese: Prodotti mediċinali mogħtija fl-istess ħin li l-aktar li għandhom rilevanza klinika Mediċini kontra l-allerġiji: montelukast
English: Presentation of the lumacaftor 400 mg q12h/ivacaftor 250 mg q12h dose group is consistent with recommended posology.
Maltese: Il-preżentazzjoni tal-grupp ta' doża ta' lumacaftor 400 mg q12h/ivacaftor 250 mg q12h hi konsistenti mal-pożoloġija rakkomandata.
English: Key Secondary Endpoints* Absolute change in BMI at Week 24 (kg/m2)
Maltese: Punti Aħħarin Sekondarji Ewlenin* Bidla assoluta fil-BMI f'Ġimgħa 24 (kg/m2)
English: Absolute change in CFQ-R Respiratory Domain Score at Week 24 (points)
Maltese: Bidla assoluta fil-Punteġġ tadDominju Respiratorju CFQ-R sa Ġimgħa 24 (punti)
English: ↔ LUM ↓ IVA
Maltese: Erb. Ħam.
English: (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (frequency cannot be estimated using the available data).
Maltese: Ir-reazzjonijiet avversi huma kklassifikati taħt il-klassifikazzjoni tal-frekwenza MedDRA: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).