FrancophonIA/ELRC3.0 huggingface dataset:
English: EMA/403685/2016 EMEA/H/C/000587
Maltese: EMA/403685/2016
English: The first infusion lasts 15 minutes.
Maltese: L-ewwel infużjoni ddum 15-il minuta.
English: The full EPAR for ATryn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance antithrombin alfa.
Maltese: Fih is-sustanza attiva antitrombina alfa
English: What is ATryn?
Maltese: Kif jaħdem ATryn?
English: ATryn is used in adults who have ‘congenital antithrombin deficiency' (inherited low levels of the protein antithrombin).
Maltese: ATryn jintuża fil-pazjenti b'defiċjenza konġenita ta' antitrombina' (tnaqqis ereditarju tal-livelli talproteina antitrombina).
English: What information is still awaited for ATryn?
Maltese: Liema informazzjoni għadha mistennija għal ATryn?
English: This document is a summary of the European Public Assessment Report (EPAR) for ATryn.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal ATryn.
English: The active substance in ATryn, antithrombin alfa, is a copy of the natural blood protein antithrombin, which is produced by ‘recombinant DNA technology': it is extracted from the milk of goats that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.
Maltese: Is-sustanza attiva f'ATryn, lantitrombina alfa, hija kopja tal-proteina naturali tad-demm l-antitrombina, li hija prodotta permezz tat-'teknoloġija rikombinanti tad-DNA': tiġi estratta mill-ħalib tal-mogħoż li kellhom ġene (DNA) inserit, li jagħmilhom kapaċi jipproduċu l-proteina umana fil-ħalib tagħhom.
English: One study of ATryn was carried out in 14 patients aged between 21 and 74 years who had congenital antithrombin deficiency and were at risk of blood clot formation either during surgery (five patients) or during childbirth (nine patients).
Maltese: Sar studju wieħed fuq ATryn f'14-il pazjent ta' età bejn 21 u 74 sena, b'defiċjenza konġenita ta' antitrombina u f'riskju ta' formazzjoni ta' għoqod tad-demm matul intervent kirurġiku (ħames pazjenti) jew matul il-ħlas (disa' pazjenti).
English: In studies, the most common side effects with ATryn (seen in between 1 and 10 patients in 100) were dizziness, headache, haemorrhage (bleeding, including bleeding at the site of the injection or after surgery), nausea (feeling sick) and wound secretion (discharge from the surgical wound).
Maltese: Matul l-istudji b'ATryn, l-effetti sekondarji l-aktar komuni (li dehru f'bejn pazjent 1 u 10 minn 100) kienu sturdament, uġigħ ta' ras, emorraġija (fsada, inkluż fsada fil-punt tal-injezzjoni jew wara lintervent kirurġiku), nawżea (dardir), tnixxija mill-feriti (mill-ferita kirurġika).
English: In the body, antithrombin blocks thrombin, a substance that plays a central role in the process of blood clotting.
Maltese: Fil-ġisem, l-antitrombina timblokka t-trombina, sustanza li tiżvolġi rwol ċentrali fil-proċess tat-tagħqid tad-demm.
English: ATryn corrects the antithrombin deficiency, and gives temporary control of the clotting disorder.
Maltese: ATryn jikkoreġi d-defiċjenza ta' antitrombina u joffri kontroll temporanju tad-disturb tat-tagħqid tad-demm.
English: Because ATryn is a protein given by injection, patients could develop antibodies (proteins produced in response to the medicine), with a risk of an allergic reaction at the time of injection.
Maltese: Billi ATryn huwa proteina mogħtija b'injezzjoni, il-pazjenti jistgħu jiżviluppaw antikorpi (proteini prodotti bħala reazzjoni għall-mediċina), b'riskju ta' reazzjoni allerġika fil-waqt tal-injezzjoni.
English: For the full list of side effects and restrictions with ATryn, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'ATryn, ara l-fuljett ta' tagħrif.
English: The CHMP concluded that the information provided by the company had shown that ATryn can bring the antithrombin activity up to an acceptable level when used at the recommended dose during surgery.
Maltese: Is-CHMP ikkonkluda li l-informazzjoni pprovduta mill-kumpanija wriet li ATryn jista' jgħolli f'livell aċċettabbli l-attività tal-antitrombina meta użata f'doża rakkomandata matul intervent kirurġiku.
English: This is followed by a continuous infusion at a lower dose, during which the patients should be continually monitored and the infusion rate adjusted, so that the antithrombin activity is at least 80% of the normal level for the duration of treatment.
Maltese: Din hija segwita minn infużjoni kontinwa f'doża inqas qawwija, li matulha l-pazjenti għandhom ikunu kkontrollati kontinwament u r-rata tal-infużjoni għandha tiġi aġġustata b'tali mod li l-attività tal-antitrombina tkun tal-anqas 80% tal-livell normali għall-perjodu li jdum it-trattament.
English: Few patients were treated during the study because congenital antithrombin deficiency is rare - it is estimated that only about one person in 3,000 to 5,000 has the condition.
Maltese: Billi d-defiċjenza konġenita ta' antitrombina hija rari, ftit huma l-pazjenti ttrattati matul l-istudju - huwa stmat li madwar persuna waħda minn 3,000 sa 5,000 tbati
English: In the study, among the 13 patients in whom the effectiveness of the treatment could be assessed, two had an episode of DVT, of which only one needed treatment.
Maltese: Fl-istudju, fost it-13-il pazjent li fihom kien possibbli li tiġi vvalutata l-effikaċja tat-trattament, tnejn kellhom episodju ta' DVT, iżda wieħed biss kien jeħtieġ trattament.
English: ATryn antithrombin alfa
Maltese: Għaliex ġie approvat ATryn?
English: The studies measured how many patients developed deep vein thrombosis (DVT, formation of a blood clot in a deep vein, usually in the leg) during the 30 days after treatment.
Maltese: L-istudji kejlu l-għadd ta' pazjenti li żviluppaw trombożi venuża fonda (deep vein thrombosis - DVT: formazzjoni ta' għoqod tad-demm f'vina fonda, ġeneralment fir-riġlejn) matul il-30 ġurnata wara t-trattament.
English: ATryn is a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: ATryn huwa trab li jsir soluzzjoni għall-infużjoni (dripp fil-vina).
English: The company that makes ATryn has provided the results of a study looking at the use of ATryn during childbirth in women with congenital antithrombin deficiency to the Agency, and will submit an application with the aim of adding treatment during childbirth to the medicine's marketing authorisation.
Maltese: Il-kumpanija li tipproduċi ATryn ipprovdiet ir-riżultati tal-istudju dwar l-użu ta' ATryn waqt il-ħlas finnisa b'defiċjenza konġenita ta' antitrombin, lill-Aġenzija, u ser tissottometti applikazzjoni formali blgħan ta' żieda fit-trattament waqt il-ħlas fl-awtorizzazzjoni għat-tqegħid fis-suq tal-mediċina.
English: ATryn is normally given with heparin (another medicine that helps to prevent blood clots).
Maltese: Normalment ATryn jingħata flimkien maleparina (mediċina oħra li tevita t-tagħqid tad-demm).
English: In addition, ATryn was used in five patients who received the medicine during surgery in a ‘compassionate-use programme' (a programme through which doctors can request a medicine for one of their patients before it is authorised).
Maltese: Barra minn hekk, ATryn intuża f'ħames pazjenti li ngħataw il-mediċina matul intervent kirurġiku flambitu ta' ‘programm ta' użu b'kumpassjoni' (programm li permezz tiegħu t-tobba jistgħu jitolbu mediċina għal wieħed mill-pazjenti tagħhom qabel ma din hija awtorizzata totalment).
English: Patients who have congenital antithrombin deficiency have low blood antithrombin levels and are therefore at increased risk of having blood clots.
Maltese: Il-pazjenti b'defiċjenza konġenita tal-antitrombina għandhom livelli baxxi ta' antitrombina fid-demm u għaldaqstant qegħdin f'riskju ikbar ta' demm li jagħqad.
English: What benefit has ATryn shown during the studies?
Maltese: X'benefiċċji wera ATryn waqt l-istudji mwettqa?
English: Adults (≥ 18 years old) n = 389
Maltese: Adulti (≥18-il sena) n=389
English: 12- to 17-year-olds n = 97
Maltese: 12- sa 17-il -sena n=97
English: Relative risk of pulmonary exacerbation
Maltese: Riskju relattiv ta' aggravament pulmonari
English: 7 tablets
Maltese: 7 pilloli
English: P value
Maltese: valur P
English: At week 8
Maltese: Sa ġimgħa 8
English: • Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (PEG 3350), talc, indigo carmine aluminium lake (E132) and carnauba wax.
Maltese: • Kisja: polyvinyl alcohol, titanium dioxide (E171), macrogol (PEG 3350), talc, indigo carmine aluminium lake (E132), u carnauba wax.
English: Vertex Pharmaceuticals (Ireland) Limited
Maltese: FIS-SUQ Vertex Pharmaceuticals (Ireland) Limited
English: • Herbal medicines such as St. John's wort (Hypericum perforatum)
Maltese: John's wort (Hypericum perforatum)
English: Ivacaftor is a substrate of CYP3A4 and CYP3A5.
Maltese: Ivacaftor hu substrat ta' CYP3A4 u CYP3A5.
English: • Printing ink: shellac, iron oxide black (E172), propylene glycol (E1520) and ammonia solution, concentrated.
Maltese: Linka tal-istampar: shellac, iron oxide black (E172), propylene glycol (E1520), u ammonia solution, concentrated.
English: Digoxin and other P-gp substrates
Maltese: Digoxin u substrati oħra ta' P-gp
English: See section 4.5 for interactions with ciclosporin or tacrolimus.
Maltese: Ara sezzjoni 4.5 għal interazzjonijiet ma' ciclosporin jew tacrolimus.
English: Co. Armagh BT63 5UA United Kingdom
Maltese: Armagh BT63 5UA
English: Adults (≥ 18 years old)
Maltese: Adulti (≥18-il sena)
English: Ivacaftor Placebo
Maltese: Ivacaftor Plaċebo
English: These medications included dornase alfa (73.1% versus 65.1%), salbutamol (53.8% versus 42.2%), tobramycin (44.9% versus 33.7%) and salmeterol/fluticasone (41.0% versus 27.7%).
Maltese: Dawn il-mediċini kienu jinkludu dornase alfa (73.1% kontra 65.1%), salbutamol (53.8% kontra 42.2%), tobramycin (44.9% kontra 33.7%) u salmeterol/fluticasone (41.0% kontra 27.7%).
English: Study 4: open-label extension study
Maltese: Studju 4: Studju ta' estensjoni open-label
English: BMI (kg/m2)
Maltese: (kg/m2)
English: Median (min, max)
Maltese: Medjan (min, mas)
English: CYP2C9 substrates
Maltese: Substrati ta' CYP2C9
English: Study 1
Maltese: Studju 1
English: D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.
Maltese: 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272‑26A→G, u 3849+10kbC→T.
English: The granules are packed in a Biaxially Oriented Polyethylene Terephthalate/Polyethylene/Foil/Polyethylene (BOPET/PE/Foil/PE) sachet.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-granijiet huma ppakkjati f'qartas Biaxially Oriented Polyethylene Terephthalate/Polyethylene/Fojl/Polyethylene (BOPET/PE/Fojl/PE).
English: 4 years.
Maltese: 4 t'ijiem.
English: • Avocados, hummus, soy-based products (tofu)
Maltese: • Avokado, ħummus, prodotti bbażati fuq is-sojja (tofu)
English: Patients grouped under mutation types (n)
Maltese: Pazjenti miġbura taħt tipi ta' mutazzjoni (n)
English: In vitro and in vivo data indicate that ivacaftor is primarily metabolised by CYP3A.
Maltese: Dejta in vitro u in vivo tindika li ivacaftor jiġi metabolizzat primarjament minn CYP3A.
English: Table 7: Mean (SD) ivacaftor exposure by age group Age group
Maltese: Tabella 7: Medja (SD) tal-esponiment ta' ivacaftor skont il-grupp ta' età Grupp ta' età
English: Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Maltese: Ivacaftor jeħel b'rata ta' madwar 99% mal-proteini tal-plażma, primarjament ma' alpha 1-acid glycoprotein u mal-albumina.
English: Pregnancy and fertility
Maltese: Tqala u fertilità
English: Titanium dioxide (E171) Macrogol (PEG 3350) Talc
Maltese: Polyvinyl alcohol Titanium dioxide (E171) Macrogol (PEG 3350)
English: Severe (Child-Pugh Class C)
Maltese: Sever (Child-Pugh Klassi C)
English: Ivacaftor is a sensitive CYP3A substrate.
Maltese: Ivacaftor hu substrat sensittiv ta' CYP3A.
English: Study 1 Ivacaftor
Maltese: Studju 1 Ivacaftor
English: In study 5, four patients with the G970R mutation were included.
Maltese: Fi studju 5, erba' pazjenti bil-mutazzjoni G970R ġew inklużi.
English: Date of first authorisation: 23 July 2012 Date of latest renewal: 28 April 2017
Maltese: Data tal-aħħar tiġdid: 28 April 2017
English: 12- to 17-year-olds
Maltese: Tfal minn 12 sa 17-il sena
English: Ivacaftor may inhibit CYP2C9.
Maltese: Ivacaftor jista' jinibixxi CYP2C9.
English: Potential for ivacaftor to interact with transporters
Maltese: Il-potenzjal li ivacaftor ikollu interazzjoni ma' trasportaturi
English: Interim analysis 1: December 2017 Interim analysis 2: December 2019 Interim analysis 3: December 2021 Final report: December 2023
Maltese: Analiżi interim 3: Diċembru 2021
English: CFQ-R respiratory domain score (points)
Maltese: CFQ- R Punteġġ ta' dominju respiratorju (punti)
English: Mild (Child-Pugh Class A)
Maltese: Ħafif (Child-Pugh Klassi A)
English: The pharmacokinetics of ivacaftor are similar between healthy adult volunteers and patients with CF.
Maltese: Il-farmakokinetika ta' ivacaftor hi simili bejn voluntiera adulti b'saħħithom u pazjenti b'CF.
English: The mean overall post-baseline value was 76.0% and 83.7%, respectively.
Maltese: Il-medja globali tal-valur wara l-linja bażi kienet ta' 76.0% u 83.7%, rispettivament.
English: BMI-for-age z-score at week 48e
Maltese: Punteġġ z BMI-għal-età f'ġimgħa 48e
English: Ivacaftor Mean (SD) Cmin, ss (ng/mL)
Maltese: Medja ta' Ivacaftor (SD) Cmin, ss (ng/mL)
English: The active substance is ivacaftor.
Maltese: Is-sustanza attiva hi ivacaftor.
English: Kalydeco 150 mg tablets
Maltese: Kalydeco 150 mg pilloli
English: Study 2 Ivacaftor
Maltese: Studju 2 Ivacaftor
English: The mean (SD) sweat chloride at baseline (n = 25) was 97.88 mmol/L (14.00).
Maltese: Il-medja (SD) ta' chloride fl-għaraq fil-linja bażi (n=25) kienet ta' 97.88 mmol/L (14.00).
English: • Loss of appetite
Maltese: • Telf ta' aptit
English: • Tablet core: cellulose microcrystalline, lactose monohydrate, hypromellose acetate succinate, croscarmellose sodium, sodium laurilsulfate (E487), silica, colloidal anhydrous, and magnesium stearate.
Maltese: • Qalba tal-pillola: cellulose, microcrystalline, lactose monohydrate, hypromellose acetate succinate, croscarmellose sodium, sodium laurilsulfate (E487), silica, colloidal anhydrous,, u magnesium stearate.
English: • Immunosuppressants such as ciclosporin, tacrolimus, everolimus and sirolimus used after an organ transplantation
Maltese: • Immunosoppressanti bħal ciclosporin, tacrolimus, everolimus u sirolimus li jintużaw wara trapjant tal-organi
English: †† n = 3 for the analysis of absolute change in sweat chloride.
Maltese: †† n=3 għall-analiżi tal-bidla assoluta fil-chloride fl-għaraq.
English: • Sinus congestion
Maltese: • Konġestjoni tas-sinus
English: A total of 36 patients continued into part 2 (18 per treatment sequence).
Maltese: Total ta' 36 pazjent komplew f'parti 2 (18 kull sekwenza ta' kura).
English: The geometric least squares mean ratio (90% CI) for the granules relative to tablets was 0.951 (0.839, 1.08) for AUC0-∞ and 0.918 (0.750, 1.12) for Cmax.
Maltese: Il-proporzjon medju talgeometric least-squares (90% CI) għall-granijiet meta mqabbla mal-pilloli kien ta' 0.951 (0.839, 1.08) għal AUC0-∞ u 0.918 (0.750, 1.12) għal Cmax.
English: • Antifungal medicines such as ketoconazole, itraconazole, posaconazole, voriconazole and fluconazole, used for the treatment of fungal infections
Maltese: • Mediċini antifungali bħal ketoconazole, itraconazole, posaconazole, voriconazole, u fluconazole, li jintużaw għal kura ta' infezzjonijiet fungali
English: Forty-eight (48) patients from study 2 were rolled over in study 4, 22 in the placebo/ivacaftor group and 26 in the ivacaftor/ivacaftor group.
Maltese: inqalbu fi studju 4, 22 fil-grupp tal-placebo/ivacaftor u 26 fil-grupp ta' ivacaftor/ivacaftor.
English: 56 sachets
Maltese: 56 qartas
English: Ivacaftor also potentiated the channel-open probability of R117H-CFTR, which has both low channel-open probability (gating) and reduced channel current amplitude (conductance).
Maltese: Ivacaftor saħħaħ ukoll ilprobabbiltà ta' channel miftuħ ta' R117H-CFTR, li għandha kemm probabbiltà ta' channel miftuħ baxxa (gating) kif ukoll amplitude tal-kurrent taċ-channel (konduttanza) imnaqqsa.
English: Ivacaftor and its metabolites are substrates of BCRP in vitro.
Maltese: Ivacaftor u lmetaboliti tiegħu huma substrati ta' BCRP in vitro.
English: Mean absolute change from baseline in CFQ-Rb respiratory domain score (points)c
Maltese: Bidla assoluta medja mil-linja bażi fil-punteġġ tad-dominju respiratorju CFQ-Rb (punti)c Sa ġimgħa 24
English: Pharmacotherapeutic group: Other respiratory system products, ATC code: R07AX02
Maltese: Prodotti oħrajn tas-sistema respiratorja, Kodiċi ATC:
English: * Treatment occurred during blinded, controlled, 48-week Phase 3 study.
Maltese: * Il-kura ngħatat waqt studju ta' Fażi 3, blinded, ikkontrollat, li dam 48 ġimgħa.
English: Treatment differencea
Maltese: Differenza filkuraa
English: Iron oxide black (E172) Propylene glycol (E1520)
Maltese: Propylene glycol (E1520)
English: Six patients with initial levels below 200 µg/g achieved, at week 24, a level of ≥ 200 µg/g.
Maltese: Sitt pazjenti b'livelli inizjali taħt 200 µg/g kisbu, f'ġimgħa 24, livell ta' 200 µg.
English: Weight-for-age z-score at week 48e
Maltese: Punteġġ z piż-għal-età f'ġimgħa 48e
English: M1 and M6 are the two major metabolites of ivacaftor in humans.
Maltese: M1 u M6 huma ż-żewġ metaboliti maġġuri ta' ivacaftor filbnedmin.
English: Through week 48
Maltese: Sa ġimgħa 48
English: Kalydeco contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Kalydeco fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis sodium'.
English: In patients heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity, the treatment difference in mean absolute change from baseline in sweat chloride through week 8 was -9.5 mmol/L (95% CI: -11.7, -7.3) between ivacaftor in combination with tezacaftor/ivacaftor and placebo, and -4.5 mmol/L (95% CI: -6.7, -2.3) between ivacaftor and placebo.
Maltese: F'pazjenti eterożigotiċi għall-mutazzjoni F508del u mutazzjoni oħra assoċjata ma' attività ta' CFTR residwali, id-differenza fil-kura fil-bidla assoluta medja mil-linja bażi fi chloride tal-għaraq sa ġimgħa 8 kienet -9.5 mmol/L (95% CI: -11.7, -7.3) bejn ivacaftor flimkien ma' tezacaftor/ivacaftor u plaċebo, u -4.5 mmol/L (95% CI: -6.7, -2.3) bejn ivacaftor u plaċebo.
English: CI: confidence interval; NA: not analysed due to low incidence of events a Treatment difference = effect of ivacaftor - effect of placebo b CFQ-R: Cystic Fibrosis Questionnaire-Revised is a disease-specific, health-related quality-of-life measure for CF.
Maltese: CI: intervall ta' kunfidenza; NA: mhux analizzat minħabba inċidenza baxxa ta' avvenimenti a Differenza tal-kura = effett ta' ivacaftor - effett ta' plaċebo b CFQ-R:
English: Lactose content
Maltese: Kontenut ta' lactose
English: • Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet)
Maltese: • Daqs tal-pakkett ta' 56 qartas (fih 4 kartieri individwali b'14-il qartas f'kull kartiera)
English: Through week 24
Maltese: Sa ġimgħa 24
English: One hundred and forty-four (144) patients from study 1 were rolled over in study 4, 67 in the placebo/ivacaftor group and 77 in the ivacaftor/ivacaftor group.
Maltese: Mija u erbgħa u erbgħin (144) pazjent minn studju 1 inqalbu fi studju 4, 67 fil-grupp talplaċebo/ivacaftor u 77 fil-grupp ta' ivacaftor/ivacaftor.
English: The other ingredients are: silica, colloidal anhydrous , croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sucralose and sodium laurilsulfate (E487).
Maltese: Is-sustanzi mhux attivi l-oħra huma: silica, colloidal anhydrous, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sucralose u sodium laurilsulfate (E487).
English: The treatment difference for ivacaftor versus placebo was -6.3 percentage points (95% CI -12.0, -0.7).
Maltese: Id-differenza fil-kura għal ivacaftor kontra lplaċebo kienet ta' -6.3 punti perċentwali (95% CI -12.0, -0.7).
English: Kalydeco contains lactose.
Maltese: TA' EĊĊIPJENTI Fih lactose.
English: Following multiple doses of ivacaftor and tezacaftor for 10 days, subjects with moderately impaired hepatic function (Child-Pugh Class B, score 7 to 9) had a 50% increase in ivacaftor AUC, and an approximate 36% and 10% increase in AUC and Cmax for tezacaftor, respectively.
Maltese: Wara dożi multipli ta' ivacaftor u tezacaftor għal 10 ijiem, individwi b'indeboliment moderat talfunzjoni epatika (Child-Pugh Klassi B, punteġġ 7 sa 9) kellhom 50% żieda fl-AUC ta' ivacaftor, u żieda ta' madwar 36% u 10% fl-AUC u Cmax għal tezacaftor, rispettivament.
English: Kalydeco 150 mg film-coated tablets are light blue, capsule-shaped, 16.5 mm x 8.4 mm, and printed with “V 150” in black ink on one side and plain on the other.
Maltese: Kalydeco 150 mg pilloli miksija b'rita huma ta' lewn blu ċar, b'forma ta' kapsula, b'daqs ta' 16.5 mm x 8.4 mm, u stampati ‘“V 150” b'linka sewda fuq naħa waħda u xejn fuq in-naħa l-oħra.
English: Ammonia solution, concentrated
Maltese: Ammonia solution, concentrated 6.2 Inkompatibbiltajiet
English: The mean (SD) overall change from baseline in Faecal Elastase-1 (n = 27) was 99.8 µg/g (138.4).
Maltese: Il-medja (SD) globali tal-bidla mil-linja bażi f'Elastase-1 fl-Ippurgar (n=27) kienet ta' 99.8 µg/g (138.4).
English: Transaminase elevations occurred in 12.8% of ivacaftor-treated patients versus 11.5% of placebo-treated patients.
Maltese: Żidiet fit-transaminases seħħew fi 12.8% tal-pazjenti kkurati b'ivacaftor kontra 11.5% tal-pazjenti kkurati bil-plaċebo.
English: The effect of the potentially reduced activity of CYP3A4 in patients carrying the CYP3A4*22 variant on ivacaftor exposure is not known.
Maltese: L-effett tal-attività potenzjalment imnaqqsa ta' CYP3A4 f'pazjenti li jkollhom il-varjant CYP3A4*22 fuq l-esponiment għal ivacaftor mhuwiex magħruf.
English: The mean change from baseline through week 24 in FEV1 (L) was 0.37 L in the ivacaftor group and 0.01 L in the placebo group in study 1 and 0.30 L in the ivacaftor group and 0.07 L in the placebo group in study 2.
Maltese: Il-bidla medja mil-linja bażi sa ġimgħa 24 f'FEV1 (L) kienet ta' 0.37 L fil-grupp ta' ivacaftor u 0.01 L fil-grupp tal-plaċebo fi studju 1 u 0.30 L fil-grupp ta' ivacaftor u 0.07 L fil-grupp tal-plaċebo fi studju 2.
English: A reduction of the Kalydeco dose is recommended for co-administration with strong CYP3A inhibitors, such as ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin and clarithromycin (see sections 4.2 and 4.4).
Maltese: Tnaqqis fid-doża ta' Kalydeco hu rakkomandat għall-għoti flimkien ma' inibituri qawwija ta' CYP3A, bħal ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin u clarithromycin (ara sezzjonijiet 4.2 u 4.4).
English: The estimated treatment difference for ivacaftor versus placebo was 5.0 percentage points (95% CI 1.1, 8.8).
Maltese: Id-differenza stmata fil-kura għal ivacaftor kontra l-plaċebo kienet ta' 5.0 punti perċentwali (95% CI 1.1, 8.8).
English: Gender The pharmacokinetic parameters of ivacaftor are similar in males and females.
Maltese: Il-parametri farmakokinetiċi ta' ivacaftor huma simili fl-irġiel u n-nisa.
English: 6- to 11-year-olds † (≥ 25 kg)
Maltese: Tfal minn 6 sa 11-il sena (≥25 kg)
English: It is a weak inhibitor of CYP3A and P-gp and a potential inhibitor of CYP2C9.
Maltese: Hu inibitur dgħajjef ta' CYP3A u P-gp u inibitur potenzjali ta' CYP2C9.