FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment is required for patients taking weak CYP3A4 inhibitors (e.g. alprazolam, atorvastatin (see section 4.5).
Maltese: Ma huwa meħtieġ ebda aġġustament tad-doża għal pazjenti li jieħdu inibituri tal-CYP3A4 moderati (eż. alprazolam, atorvastatin (ara sezzjoni 4.5).
English: Clinically important disruptions of the blood-brain barrier Naloxegol is a peripherally acting mu-opioid receptor antagonist with restricted access to the central nervous system (CNS).
Maltese: Naloxegol huwa antagonista tar-riċettur tal-mu-opjojd b'azzjoni periferika b'aċċess ristrett għas sistema nervuża ċentrali (CNS - central nervous system).
English: Under multiplicity testing procedure, statistical significance for the 12.5 mg treatment group versus placebo in the LIR subgroup was observed in Kodiac 4 (p=0.028) but not in Kodiac 5 (p=0.074).
Maltese: ttestjar tal-multipliċità, kien osservat sinifikat statistiku għall-grupp ta' kura ta' 12.5 mg meta mqabbel ma' plaċebo fis-sottogrupp LIR f'Kodiac 4 (p=0.028) iżda mhux f'Kodiac 5 (p=0.074).
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jista' jaffettwa sa persuna 1 minn kull 10):
English: Kodiac 8 was a Phase III, 52-week, multi-center, open-label, randomized, parallel group, safety and tolerability study of naloxegol versus usual care in the treatment of OIC in patients with non-cancer-related pain.
Maltese: Kodiac 8 kien studju tas-sigurtà u t-tollerabbiltà,ta' grupp parallel, randomizzat, b'tikketta miftuħa, multi-ċentrali, ta' 52 ġimgħa, tal-Fażi III ta' naloxegol meta mqabbel mal-kura tas-soltu ta' OIC
English: In all treatment groups, including placebo, improvements in PAC-SYM domains observed in Kodiac 4 were maintained for patients continuing in Kodiac 7.
Maltese: Fil-gruppi ta' kura kollha, inkluż plaċebo, it-titjib fid-dominji PAC-SYM li ġew osservati f'Kodiac 4 inżammu għal pazjenti li komplew f'Kodiac 7.
English: Mechanism of action and pharmacodynamic effects Naloxegol is a PEGylated derivative of the mu-opioid receptor antagonist naloxone.
Maltese: Naloxegol huwa derivattiv PEGilat tal-antagonista tar-riċettur tal-mu-opjojde naloxone.
English: There was a statistically significant difference for the 25 mg dose versus placebo for the LIR subgroup responder rate in Kodiac 4 (p=0.002) and Kodiac 5 (p=0.014).
Maltese: Kien hemm differenza statistikament sinifikanti għad-doża ta' 25 mg meta mqabbel ma' plaċebo għar rata ta' rispons tas-sottogrupp LIR f'Kodiac 4 (p=0.002) u Kodiac 5 (p=0.014).
English: Moventig 25 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 25 mg naloxegol.
Maltese: Moventig 25 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha naloxegol oxalate ekwivalenti għal 25 mg naloxegol.
English: In a clinical study of patients with OIC, a daily dose of 50 mg was associated with an increased incidence of intolerable gastrointestinal effects (primarily abdominal pain).
Maltese: Fi studju kliniku tal-pazjenti b'OIC, doża ta' kuljum ta' 50 mg kienet assoċjata ma' żieda fl-inċidenza tal-effetti gastrointestinali intollerabbli (prinċipalment uġigħ ta' żaqq).
English: Moventig 25 mg: a mauve coloured, oval, dimensions 13 x 7 mm, film-coated tablet, marked “nGL” on one side and “25” on the other side.
Maltese: Moventig 25 mg: pillola miksija b'rita b'dimensjonijiet ta' 13 x 7 mm, ovali, ta' kulur vjola,
English: Moventig 12.5 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 12.5 mg naloxegol.
Maltese: Moventig 12.5 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha naloxegol oxalate ekwivalenti għal 12.5 mg naloxegol.
English: • medicines called ‘opioid antagonists' (such as naltrexone and naloxone) which are used to counteract the effects of opioids
Maltese: • mediċini msejħa ‘antagonisti tal-opjojdi' (bħal naltrexone u naloxone) li jintużaw għal kontra l effetti tal-opjojdi
English: In an open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate the effect of multiple doses of diltiazem on the single dose PK of naloxegol, co-administration of diltiazem and naloxegol resulted in a 3.4-fold (90% CI: 3.2-3.7) increase in naloxegol AUC and a 2.9fold increase in naloxegol Cmax (90% CI: 2.6-3.1), compared to when naloxegol was administered alone.
Maltese: Interazzjoni ma' inibituri tal-CYP3A4 moderati Fi studju inkroċjat, open label, mhux randomizzat, b'sekwenza fissa, bi 3 perjodi, 3 trattamenti biex jiġi evalawat l-effett ta' dożi multipli ta'diltiazem fuq il-PK ta' doża waħda ta' naloxegol, l-għoti flimkien ta' diltiazem u naloxegol irriżulta f'żieda ta' 3.4-il darba (90% CI: 3.2-3.7) fl-AUC ta'
English: • allergic reaction • gastrointestinal perforation (a hole developing in the bowel wall)
Maltese: • perforazzjoni gastrointestinali (toqba li qed tiżviluppa fil-ħajt tal-musrana)
English: The efficacy and safety of naloxegol was established in two replicate double-blind, placebo-controlled studies in patients with OIC and non-cancer related pain (Kodiac 4 and Kodiac 5).
Maltese: L-effikaċja u s-sigurtà ta' naloxegol ġiet stabbilita f'żewġ studji double-blind replikati, ikkontrollati bi plaċebo f'pazjenti b'OIC u uġigħ mhux relatat mal-kanċer (Kodiac 4 u Kodiac 5).
English: Patients with clinically important disruptions to the blood-brain barrier (e.g. primary brain malignancies, CNS metastases or other inflammatory conditions, active multiple sclerosis, advanced Alzheimer's disease etc.) were not included in clinical studies and may be at risk for naloxegol entry into the CNS.
Maltese: Il-pazjenti b'disturbi klinikament importanti fil-barriera ta' bejn id-demm u l-moħħ (eż. tumuri malinni primarji fil-moħħ, metastasi fisCNS jew kundizzjonijiet infjammatorji oħrajn, sklerożi multipla attiva, marda ta' Alzheimer avvanzata, eċċ.) ma kinux inklużi fl-istudji kliniċi u jistgħu jkunu f'riskju li naloxegol jidħol fis-CNS.
English: Available toxicological data in rats have shown naloxegol excreted in milk (see section 5.3).
Maltese: Dejta tossikoloġika disponibbli fil-firien uriet li kien hemm eliminazzjoni ta' naloxegol fil-ħalib (ara sezzjoni 5.3).
English: Effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naloxegol was not evaluated.
Maltese: L-effett fuq l-indeboliment tal fwied sever (Child-Pugh Klassi C) fuq il-farmakokinetika ta' nalogexol ma ġiex evalwat.
English: Mean number of days per week with at least one SBM There was an increase in the mean number of days per week with at least one SBM in the LIR subgroup for the 25 mg dose in Kodiak 4 and Kodiac 5 (p<0.001 in both studies) and also for the 12.5 mg dose (p=0.006 in both studies).
Maltese: Numru medju ta' ġranet kull ġimgħa b'ta' lanqas SBM wieħed Kien hemm żieda fin-numru medju ta' jiem fil-ġimgħa b'tal-anqas SBM wieħed fis-sottogrupp LIR għad-doża ta' 25 mg f'Kodiac 4 u Kodiac 5 (p<0.001 fiż-żewġ studji) u anki għad-doża ta' 12.5 mg (p=0.006 fiż-żewġ studji).
English: • if you are taking methadone (see section below “Other medicines and Moventig”)
Maltese: • jekk qed tieħu methadone (ara sezzjoni taħt “Mediċini oħra u Moventig”)
English: Naloxegol 25 mg dose, compared with placebo, also resulted in greater improvement (change from baseline) of week 12 PAC-SYM rectal domain scores in both studies (p=0.004 and p<0.001, Kodiac 4 and 5, respectively) and for the stool domain scores in Kodiac 4 (p=0.031) and Kodiac 5 (p<0.001).
Maltese: Id-doża ta' 25 mg ta' naloxegol, meta mqabbel ma' plaċebo, irriżultat ukoll f'titjib akbar (bidla mil-linja bażi) tal-punteġġi tad-dominju rettali tal-SYM tal-PAC ta' 12-il ġimgħa fiż-żewġ studji (p=0.004 u p<0.001, Kodiac 4 u 5,
English: Moventig 12.5 mg film-coated tablets naloxegol
Maltese: Moventig 12.5 mg pilloli miksijin b'rita naloxegol
English: Naloxegol was found to have no effect on fertility of male and female rats at oral doses up to 1,000 mg/kg per day (greater than 1,000 times the human therapeutic exposure (AUC) at the recommended human dose of 25 mg/day).
Maltese: Naloxegol instab li ma għandu ebda effett fuq il-fertilità tal-firien irġiel u nisa f'dożi orali sa 1,000 mg/kg kuljum (aktar minn 1,000 darba l-esponiment terapewtiku tal-bniedem (AUC) fid-doża rakkomandata għall-bniedem ta' 25 mg/kuljum).
English: Note: Selection of ADRs and their frequencies based on the 25 mg dose a Reflects MedDRA Preferred Terms of: “abdominal pain”, “abdominal pain upper”, “abdominal pain lower” and “gastrointestinal pain”.
Maltese: Nota: Għażla ta' ADRs u l-frekwenzi tagħhom fuq il-bażi tad-doża ta' 25 mg a Tirrifletti t-Termini Preferuti ta' MedDRA ta': “uġigħ ta' żaqq”, “uġigħ ta' żaqq fin-naħa ta' fuq”, “uġigħ ta' żaqq fin-naħa ta' isfel” u “uġigħ gastrointestinali”.
English: • diltiazem or verapamil (for high blood pressure or angina).
Maltese: • jekk tieħu diltiazem jew verapamil (għal pressjoni tad-demm għolja jew anġina)
English: The Cmax and area under the plasma concentration-time curve (AUC) were increased by approximately 30% and 45%, respectively.
Maltese: Is-Cmax u l erja taħt il-kurva tal-ħin u l-konċentrazzjoni fil-plażma (AUC) żdiedu b'madwar 30 % u 45 %,
English: A QTc study performed with naloxegol in healthy volunteers did not indicate any prolongation of the QT interval.
Maltese: Studju tal-QTc b'naloxegol li sar f'voluntiera b'saħħithom ma indika ebda titwil tal-intervall tal-QT.
English: Moventig 25 mg film-coated tablet (tablet).
Maltese: Moventig 25 mg pillola miksija b'rita (pillola).
English: Hyperhidrosis
Maltese: Iperidrożi
English: At therapeutic doses, most opioids (e.g. morphine, meperidine, methadone) are excreted into breast milk in minimal amounts.
Maltese: Fid-dożi terapewtiċi, il-biċċa l-kbira tal-opjojdi (eż. morfina, meperidine, methadone) huma eliminati fil-ħalib tas-sider f'ammonti minimi.
English: For definition of inadequate response to laxative(s), see section 5.1.
Maltese: Għal definizzjoni ta' rispons mhux adegwat għal lassativ(i), ara sezzjoni 5.1.
English: Pack sizes of 10, 30 and 90 film-coated tablets in non-perforated blisters.
Maltese: Daqsijiet tal-pakkett ta' 10, 30 u 90 pillola miksija b'rita f'folji mhux imtaqqba.
English: Nasopharyngitis
Maltese: MEDIĊINALI
English: There was a higher incidence of discontinuations in patients taking the 25 mg dose compared to placebo due to diarrhoea (0.7% for placebo versus 3.1% for naloxegol 25 mg) and abdominal pain (0.2% versus 2.9%, respectively).
Maltese: Kien hemm inċidenza ogħla ta' waqfien f'pazjenti li kienu qegħdin jieħdu d-doża ta' 25 mg meta mqabbel mal-plaċebo minħabba dijarea (0.7 % għallplaċebo meta mqabbel ma' 3.1 % għal naloxegol 25 mg) u uġigħ addominali
English: Patients with known or suspected gastrointestinal (GI) obstruction or in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation (see section 4.4).
Maltese: ostruzzjoni rikorrenti, minħabba l-potenzjal ta' perforazzjoni gastrointestinali (ara sezzjoni 4.4).
English: • if your opioid medicine is to be stopped for more than 24 hours
Maltese: • jekk il-mediċina tal-opjojdi tiegħek trid titwaqqaf għal aktar minn 24 siegħa
English: − Each Moventig 12.5 mg film-coated tablet (tablet) contains 12.5 mg naloxegol as naloxegol oxalate.
Maltese: Kull pillola miksija b'rita fiha 12.5 mg naloxegol (bħala naloxegol oxalate).
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Caution with regards to the use of naloxegol should be exercised in patients with any condition which might result in impaired integrity of the gastrointestinal tract wall (e.g. severe peptic ulcer disease, Crohn's Disease, active or recurrent diverticulitis, infiltrative gastrointestinal tract malignancies or peritoneal metastases).
Maltese: Għandha tiġi eżerċitata l-kawtela fir-rigward tal-użu ta' naloxegol f'pazjenti bi kwalunkwe kundizzjoni li tista' tirriżulta f'indeboliment tal-integrità tal-ħajt tal-passaġġ gastrontestinali (eż. mard b'ulċeri peptiċi severi, Marda ta' Crohn, divertikulite attiva jew rikorrenti, tumuri malinni infiltrattivi fil-passaġġ gastrointestinali jew metastasi tal-peritonew).
English: Safety and tolerability over an extended 12-week period Kodiac 7 was a 12-week safety extension that allowed for patients from Kodiac 4 to continue the same blinded treatment from Kodiac 4 for an additional 12 weeks (placebo, naloxegol 12.5 mg or 25 mg daily).
Maltese: Kodiac 7 kienet estensjoni tas-sigurtà ta' 12-il ġimgħa li ppermettiet lill-pazjenti minn Kodiac 4 ikomplu l-istess kura blinded minn Kodiac 4 għal 12-il ġimgħa oħra (plaċebo, naloxegol 12.5 mg jew 25 mg kuljum).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or any other opioid antagonist.
Maltese: Sensittività eċċessiva Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1 jew kwalunkwe antagonist tal-opjojdi ieħor.
English: − Each Moventig 25 mg film-coated tablet (tablet) contains 25 mg naloxegol as naloxegol oxalate.
Maltese: Kull pillola miksija b'rita fiha 25 mg naloxegol (bħala naloxegol oxalate).
English: The blood brain barrier integrity is important for minimizing naloxegol uptake into the CNS.
Maltese: L-integrità tal-barriera ta' bejn id-demm u l moħħ hija importanti biex jitnaqqas it-teħid ta' naloxegol fis-CNS.
English: • stomach pain • diarrhoea (passing of frequent, watery stools)
Maltese: • dijarea (tipporga maħlul u b'mod frekwenti)
English: Naloxegol as a crushed tablet mixed in water, given orally or administered through a nasogastric tube into the stomach, is bioequivalent to the whole tablet, with a median tmax of 0.75 and 1.50 hours (range 0.23 to 5.02 hours) for the crushed tablet given orally and the crushed tablet given via NG tube, respectively.
Maltese: Naloxegol bħala pillola mfarrka mħallat mal-ilma, mogħti mill-ħalq jew mogħti permezz ta' tubu nażogastriku fl-istonku, huwa bijoekwivalenti għall-pillola kollha, b' tmax medju ta' 0.75 u 1.50 sigħat (firxa ta' 0.23 sa 5.02 sigħat) għall-pillola mfarrka mogħtija mill-ħalq u l-pillola mfarrka mogħtija permezz ta' tubu NG, rispettivament.
English: A possible treatment-related foetal skeletal malformation of fused arches was noted at highest dose tested in the rabbit embryo-foetal development study, in the absence of maternal toxicity.
Maltese: Ġiet innotata malformazzjoni skeletali possibbli tal-fetu relatata mal-kura ta' fused arches fl-ogħla doża fl-istudju ta' żvilupp embrijo-fetali fil-fniek, fin-nuqqas ta' tossiċità materna.
English: Of the 844 patients who were randomized, 61.1% completed the study (defined as completing the 2-week follow-up visit after the 52-week treatment period).
Maltese: Minn 844 pazjent li kienu randomizzati, 61.1 % lestew l-istudju (iddefiniti bħala li lestew iż-żjara ta'
English: Consideration may be given to lowering the dose to 12.5mg in patients experiencing severe gastrointestinal adverse events depending upon the response and tolerability of individual patients.
Maltese: Jista' jiġi kkunsidrat li titnaqqas id-doża għal 12.5 mg f'pazjenti li jgħaddu minn avvenimenti gastrointestinali avversi severi skont ir rispons u t-tollerabbiltà tal-pazjenti individwali.
English: Overall 393 and 317 patients had at least 6 and 12 months exposure to naloxegol 25 mg, respectively, in this study, which met the specified exposure requirements.
Maltese: B'mod globali 393 u 317-il pazjent kellhom tal-anqas esponiment ta' 6 u 12-il xahar għal naloxegol 25 mg, rispettivament, f'dan l-istudju,
English: Paediatric population The pharmacokinetics of naloxegol in the paediatric population has not been studied.
Maltese: UŻU Prodott mediċinali li jingħata bir-riċetta tat-tabib.
English: Interaction with other opioid antagonists
Maltese: Interazzjoni ma' antagonisti oħra tal-opjojdi
English: Refer to section 6.6 for further information on administration through a nasogastric tube.
Maltese: Irreferi għal sezzjoni 6.6 għal aktar informazzjoni dwar l-amministrazzjoni permezz ta' tubu nażogastriku.
English: However, in 2 out of 8 patients (in both the moderate and severe renal impairment groups but not in the end stage renal failure group) up to 10-fold increases in the exposure of naloxegol were observed.
Maltese: Madankollu, f'2 pazjenti minn 8 pazjenti (kemm fi gruppi b'indeboliment tal-kliewi moderat u sever iżda mhux fil-grupp ta' insuffiċjenza tal-kliewi fl-istadju finali) kienu osservati sa żieda sa 10 darbiet fl-esponiment ta' naloxegol.
English: Moventig is not recommended for use in children and adolescents below 18 years of age because it has not been studied in these age-groups.
Maltese: Moventig mhuwiex rakkomandat għall-użu fi tfal u adoloxxenti li għandhom inqas minn 18-il sena peress li ma ġiex studjat f'dawn il-gruppi ta' età.
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: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.
English: The starting dose for patients taking moderate CYP3A4 inhibitors (e.g. diltiazem, verapamil) is 12.5 mg once daily.
Maltese: Id-doża tal-bidu għal pazjenti li jieħdu inibituri tal-CYP3A4 moderati (eż. diltiazem, verapamil) hija ta' 12.5 mg darba kuljum.
English: In an open-label, non-randomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate the effect of multiple doses of ketoconazole on the single dose PK of naloxegol, co-administration of ketoconazole and naloxegol resulted in a 12.9 fold (90% CI: 11.3-14.6) increase in naloxegol AUC and a 9.6-fold increase in naloxegol Cmax (90% CI: 8.1-11.3), compared to when naloxegol was administered alone.
Maltese: Fi studju inkroċjat open label, mhux randomizzat, b'sekwenza fissa, bi 3 perjodi, 3 trattamenti biex jiġi evalawat l-effett ta' dożi multipli ta' ketoconazole fuq id-doża waħda PK ta' naloxegol, amministrazzjoni ta' ketoconazole flimkien ma' naloxegol irriżulta f'żieda ta' 12.9-il darba (90% CI:
English: Patients who had a QTcF >500 msec at screening, had a recent history of myocardial infarction within 6 months before randomization, had symptomatic congestive heart failure, or had any other overt CV disease were excluded from the clinical studies.
Maltese: Il-pazjenti li kellhom QTcF >500 msec fl-iskrinjar, li kellhom storja riċenti ta' infart mijokardijaku fi żmien 6 xhur qabel irrandomizzazzjoni, li kellhom insuffiċjenza konġestiva sintomatika tal-qalb, jew li kellhom xi marda CV oħra evidenti kienu esklużi mill-istudji kliniċi.
English: 4 years
Maltese: 3 LISTA
English: The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.2).
Maltese: Id-doża tista' tiżdied għal 25 mg, jekk 12.5 mg hija tollerata sew mill-pazjent (ara sezzjoni 4.2).
English: Patients taking methadone as primary therapy for their pain condition were observed in clinical trials to have a higher frequency of gastrointestinal adverse reactions (such as abdominal pain and diarrhoea) than patients not receiving methadone.
Maltese: Il-pazjenti li jieħdu methadone bħala terapija primarja għall-kundizzjoni tal-uġigħ tagħhom kienu osservati fi provi kliniċi bħala li għandhom frekwenza ogħla ta' reazzjonijiet avversi gastrointestinali (bħal uġigħ addominali u dijarea) minn pazjenti li ma kinux qegħdin jirċievu methadone.
English: Pack sizes of 30 x 1 and 90 x 1 film-coated tablets in perforated unit dose blisters.
Maltese: Daqsijiet tal-pakkett ta' 30 x 1 u 90 x 1 pillola miksija b'rita f'folji mtaqqba b'doża waħda.
English: Potential for interference with opioid-mediated analgesia There were no clinically relevant differences between naloxegol 12.5 mg, 25 mg, and placebo in average pain intensity, daily opioid dose or in opioid withdrawal scores over the 12-week study.
Maltese: Ma kien hemmx differenza klinikament rilevanti bejn naloxegol 12.5 mg, 25 mg, u plaċebo fl-intensità medja tal-uġigħ, id-doża tal-opjojdi ta' kuljum, jew fil-punteġġi tal-irtirar tal-opjojdi matul l-istudju ta'
English: Interaction with strong CYP3A4 inducers
Maltese: Interazzjoni ma' inibituri u indutturi tal-CYP3A4
English: Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets
Maltese: Moventig 12.5 mg pilloli miksijin b'rita Moventig 25 mg pilloli miksijin b'rita
English: Enterohepatic recirculation may be an explanation as extensive biliary excretion was seen in the rat.
Maltese: Ir-riċirkolazzjoni enteroepatika tista' tkun spjegazzjoni peress li ġiet osservata eliminazzjoni biljari estensiva fil-far.
English: Skin and subcutaneous tissue disorders
Maltese: Sistema talKlassifikazzjoni tal-Organi
English: A double-blind, randomized, 2-part, crossover, single centre study was conducted to evaluate the effect of quinidine on the pharmacokinetics of naloxegol and the effect of the co-administration of naloxegol and quinidine on morphine-induced miosis in healthy volunteers.
Maltese: Sar studju double-blind, randomizzat, b'żewġ partijiet, inkroċjat, b'ċentru wieħed biex jiġi evalwat l effett ta' quinidine fuq il-farmakokinetiċi ta' naloxegol u l-effett tal-amministrazzjoni ta' naloxegol flimkien ma' quinidine fuq mijożi indotta mill-morfina f'voluntiera b'saħħitom.
English: CYP3A4 inducers
Maltese: Indutturi tal-CYP3A4
English: Moventig 25 mg film-coated tablets naloxegol
Maltese: Moventig 25 mg pilloli miksijin b'rita naloxegol
English: Long-term safety and tolerability
Maltese: Sigurta u tollerabbiltà fit-tul
English: Hepatic impairment
Maltese: rtirar talopjojdi
English: • if you have cancer in your gut or ‘peritoneum' (the lining of your stomach area), advanced or recurrent ovarian cancer or if you are taking medicines used to treat cancer such as “VEGF inhibitors” (e.g. bevacizumab).
Maltese: • jekk għandek kanċer f'imsarnek jew ‘peritoneum' (l-inforra tal-istonku tiegħek), kanċer flovarji avvanzat jew rikorrenti jew qed tieħu mediċini użati għall-kura tal-kanċer bħal “inibituri tal-VEGF” (eż. bevacizumab).
English: There is limited clinical experience with the use of naloxegol in OIC patients with cancer-related pain.
Maltese: Hemm esperjenza klinika limitata bl-użu ta' naloxegol f'pazjenti OIC b'uġigħ relatat mal-kanċer.
English: Therefore, Moventig is not recommended in patients who are taking strong CYP3A4 inducers (see section 4.4).
Maltese: Għaldaqstant, Moventig mhuwiex rakkomandat f'pazjenti li jkunu qegħdin jieħdu indutturi tal-CYP3A4 qawwija (ara sezzjoni 4.4).
English: The first of three multiplicity protected secondary endpoints was the 12-week responder rate in the LIR subgroup.
Maltese: L-ewwel minn tliet punti ta' tmiem sekondarji protetti mill-multipliċità kienet ir-rata ta' rispons ta' 12-il ġimgħa fis-sottogrupp LIR.
English: Safety and efficacy have not been established in patients with severe hepatic impairment (see section 5.2).
Maltese: Is-sigurtà u leffikaċja f'pazjenti b'indeboliment tal-fwied sever ma ġewx determinati (ara sezzjoni 5.2).
English: • headache
Maltese: • gass
English: CYP3A4 inhibitors
Maltese: Inibituri tal-CYP3A4
English: In the pooled data from clinical trials the most commonly reported adverse reactions with naloxegol (≥ 5%) are: abdominal pain, diarrhoea, nausea, headache and flatulence.
Maltese: Fid-dejta miġbura mill-provi kliniċi, ir-reazzjonijiet avversi l-aktar irrapportati b'naloxegol (≥ 5%) huma: uġigħ ta' żaqq, dijarea, dardir, uġigħ ta' ras u gass.
English: The 12.5 mg dose in the LIR subgroup also demonstrated shorter time to first post-dose SBM as compared to placebo in Kodiac 4 (p=0.002) and Kodiac 5 (p<0.001).
Maltese: 25 mg meta mqabbel mal-plaċebo f'Kodiac 4 (p<0.001) u Kodiac 5 (p=0.002).
English: Grapefruit juice has been classified as a potent CYP3A4 inhibitor when consumed in large quantities.
Maltese: Il-meraq tal-grejpfrut ġie kklassifikat bħala inibitur talCYP3A4 qawwi meta kkunsmat fi kwantitajiet kbar.