FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk management plan has been developed to ensure that Vylaer Spiromax is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Vylaer Spiromax jintuża bl-aktar mod sigur possibbli.
English: For asthma reliever therapy, patients should take a separate ‘reliever inhaler' to relieve their symptoms.
Maltese: Għal terapija għat-tnaqqis tas-sintomi talażma, il-pazjenti għandhom jieħdu ‘inalatur għat-tnaqqis tas-sintomi' separat biex inaqqsu s-sintomi tagħhom.
English: 2132NP Hoofddorp The Netherlands
Maltese: 2132NP Hoofddorp In-Netherlands
English: Northumberland, NE61 3YA United Kingdom
Maltese: Northumberland, NE61 3YA Ir-Renju Unit
English: • clarithromycin or telithromycin - antibiotics
Maltese: • clarithromycin jew telithromycin - antibijotiċi
English: Symptom responder end-point
Maltese: Punt ta' tmiem tar-responder tas-sintomi
English: Moventig contains sodium
Maltese: Moventig fiha sodium
English: Piramal Pharma Solutions (Dutch) B.V. Bargelaan 200 u 715
Maltese: Piramal Pharma Solutions (Dutch) B.V.
English: Gastrointestinal perforation (see section 4.4)
Maltese: Perforazzjoni gastrointestinali (ara sezzjoni 4.4)
English: Date of first authorisation: 8 December 2014 Date of latest renewal: 23 September 2019
Maltese: Data tal-aħħar tiġdid: 23 ta' Settembru 2019
English: • rifampin (an antibiotic), carbmazepine (for epilepsy) or the herbal medicine St. John's wort (for depression).
Maltese: • rifampin (antibijotiku), carbmazepine (għal epilessija) jew il-mediċina erbali St John's wort
English: The responder rates in this population were placebo 30.0%, 12.5 mg 44.3% and 25 mg 44.4%.
Maltese: 30.0 %, 12.5 mg 44.3 % u 25 mg 44.4 %.
English: Alu/alu blister.
Maltese: Alu/folja tal-alu.
English: EU/1/14/962/001 EU/1/14/962/002 EU/1/14/962/003 EU/1/14/962/004 EU/1/14/962/005 EU/1/14/962/006 EU/1/14/962/007 EU/1/14/962/008 EU/1/14/962/009 EU/1/14/962/010 EU/1/14/962/011
Maltese: EU/1/14/962/005 EU/1/14/962/006 EU/1/14/962/007 EU/1/14/962/008 EU/1/14/962/009 EU/1/14/962/010
English: • underlying malignancies of gastrointestinal tract or peritoneum
Maltese: • tumuri malinni sottostanti tal-passaġġ gastrointestinali jew tal-peritoneum
English: • ketoconazole or itraconazole - to treat fungal infections
Maltese: • ketoconazole jew itraconazole - biex tikkura infezzjonijiet fungali
English: There was no relevant impact on abdominal symptoms in either study (p=0.256 and p=0.916, Kodiac 4 and 5, respectively).
Maltese: Ma kien hemm ebda impatt rilevanti fuq is-sintomi addominali fl-ebda studju (p=0.256 i p=0.916, Kodiac 4 u 5, rispettivament).
English: Tablet core mannitol (E421) cellulose microcrystalline (E460) croscarmellose sodium (E468) magnesium stearate (E470b) propyl gallate (E310)
Maltese: Qalba tal-pillola mannitol (E421) cellulose microcrystalline (E460) croscarmellose sodium (E468) magnesium stearate (E470b) propyl gallate (E310)
English: Table 1 Adverse reactions by System Organ Class (SOC) and frequency System Organ Classification
Maltese: Tabella 1 Reazzjonijiet avversi skont is-Sistema tal-Klassifikazzjoni tal-Organi (SOC) u lfrekwenza
English: Gastrointestinal obstruction
Maltese: Disturbi gastrointestinali
English: Tablet coat hypromellose (E464) titanium dioxide (E171) macrogol (E1521) iron oxide red (E172) iron oxide black (E172)
Maltese: Kisja tal-pillola hypromellose (E464) titanium dioxide (E171) macrogol (E1521) iron oxide red (E172) iron oxide black (E172)
English: Interaction with P-gp inhibitors
Maltese: Interazzjoni ma' inibituri tal-P-gp
English: Less than 20% decrease in AUC and 10% decrease in Cmax were observed in patients with mild and moderate hepatic impairment (Child-Pugh Class A and B).
Maltese: Kienu osservati tnaqqis ta' anqas minn 20 % fl-AUC u tnaqqis ta' 10 % fis-Cmax f'pazjenti b'indeboliment tal-fwied ħafif u moderat (Child-Pugh Klassi A u B).
English: Moventig contains the active substance naloxegol.
Maltese: Moventig fih is-sustanza attiva naloxegol.
English: • The active substance is naloxegol.
Maltese: • Is-sustanza attiva hija naloxegol.
English: The mean apparent volume of distribution during the terminal phase (Vz/F) in healthy volunteers ranged from 968 to 2,140 L across dosing groups and studies.
Maltese: Il-volum evidenti medju ta' distribuzzjoni matul il-fażi terminali (Vz/F) f'voluntiera b'saħħithom varja minn 968 sa 2,140 L fil-gruppi ta' dożaġġ u l-istudji.
English: − tablet core: mannitol (E421), cellulose microcrystalline (E460), croscarmellose sodium (E468) - see section 2 under ‘Moventig contains sodium', magnesium stearate (E470b), propyl gallate (E310)
Maltese: − qalba tal-pillola: Mannitol (E421), cellulose microcrystalline (E460), croscarmellose sodium (E468) - ara sezzjoni 2 taħt ‘Moventig fih is-sodium', magnesium stearate (E470b), propyl gallate (E310)
English: Pack sizes of 10 x 1, 30 x 1, 90 x 1 and 100 x 1 film-coated tablets in perforated unit dose blisters.
Maltese: Daqsijiet tal-pakkett ta' 10 x 1, 30 x 1, 90 x 1 u 100 x 1 pillola miksija b'rita f'folji mtaqqba b'doża waħda.
English: In a pooled analysis of Kodiac 4 and Kodiac 5 (90, 88 and 99 patients in the placebo, 12.5 mg and 25 mg groups respectively), higher response rates in this population was observed for the 25 mg dose group compared with placebo (p=0.040).
Maltese: F'analiżi miġbura ta' Kodiac 4 u Kodiac 5 (90, 88 u 99 pazjent fil-gruppi ta' plaċebo, 12.5 mg u 25 mg rispettivament), ġew osservati rati ta' rispons ogħla f'din il-popolazzjoni għal grupp ta' doża ta' 25 mg meta mqabbel ma' plaċebo (p=0.040).
English: − film-coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), iron oxide red (E172) and iron oxide black (E172).
Maltese: − rita tal-pillola: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), iron oxide aħmar (E172) and iron oxide iswed (E172).
English: Oval, 13x7 mm, mauve tablet.
Maltese: Pillola vjola, 13x7 mm, ovali.
English: According to the ICH E14 Guideline, this is considered a definitively negative thorough QT/QTc study.
Maltese: Skont il-Linja gwida ICH E14, dan huwa meqjus studju QT/QTc bir-reqqa definittivament negattiv.
English: • ritonavir, indinavir or saquinavir - to treat HIV
Maltese: • ritonavir, indinavir jew saquinavir - għall-kura tal-HIV
English: Co-administration of the P-gp inhibitor quinidine resulted in a 1.4 fold increase in the AUC (90% CI: 1.3-1.5) and a 2.4 fold increase in the Cmax (90% CI: 2.2-2.8) of naloxegol.
Maltese: L-għoti flimkien talinibitur tal-P-gp quinidine irriżulta f'żieda ta' 1.4-il darba fl-AUC (90% CI: 1.3-1.5) u f'żieda ta' 2.4-il darba f'Cmax (90% CI: 2.2-2.8) ta' naloxegol.
English: Concomitant use with strong CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, itraconazole or telithromycin; protease inhibitors such as ritonavir, indinavir or saquinavir; grapefruit juice when consumed in large quantities), see section 4.5.
Maltese: L-użu flimkien ta' inibituri tal-CYP3A4 qawwija (eż. clarithromycin, ketoconazole, itraconazile jew telithromycin; inibituri tal-protease bħal ritonavir, indinavir jew saquinavir; meraq tal-grejpfrut meta kkunsmat fi kwantitajiet kbar), ara sezzjoni 4.5.
English: • nasopharyngitis (runny or stuffy nose)
Maltese: • nawsja (dardir fl-istonku)
English: Gastrointestinal disorders
Maltese: Ostruzzjoni gastrointestinali
English: Do not take Moventig if you are taking any of the following medicines (see section “Do not take Moventig”):
Maltese: Tiħux Moventig jekk qed tieħu xi waħda mill-mediċini li ġejjin (ara sezzjoni “Tiħux Moventig”):
English: Cases of opioid withdrawal syndrome have been reported in the naloxegol clinical programme (DSM5).
Maltese: Każijiet ta' sindromu tal-irtirar mill-opjojdi ġew irrappurtati fil-programm kliniku ta' naloxegol (DSM-5).
English: In clinical pharmacology studies, the half-life of naloxegol at therapeutic dose ranged from 6-11 hours.
Maltese: Fi studji farmakoloġiċi kliniċi, il-half life ta' naloxegol fid-doża terapewtika kienet tvarja minn 6 sa 11-il siegħa.
English: Moventig 25 mg tablets naloxegol
Maltese: Pilloli ta' Moventig 25 mg naloxegol
English: • if you experience symptoms of opioid withdrawal syndrome (see section 4 below).
Maltese: • jekk tesperjenza sintomi ta' sindromu ta' rtirar mill-opjojdi (ara sezzjoni 4 hawn isfel).
English: • vascular endothelial growth factor (VEGF) inhibitor treatment.
Maltese: • kura b'inibitur ta' fattur tat-tkabbir endoteljali vaskulari (VEGF - vascular endothelial growth factor).
English: Doses of naloxegol up to 1,000 mg were administered in healthy volunteers in clinical studies.
Maltese: Ingħataw dożi ta' naloxegol sa 1,000 mg f'voluntiera b'saħħithom fi studji kliniċi.
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ilkategoriji ta' frekwenza huma ddefiniti skont il-konvenzjonijiet li ġejjin: 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).
English: Moventig 25 mg tablets are available in aluminium blisters in pack sizes of 10, 30 or 90 film--coated tablets in non-perforated blisters and 10x1, 30x1, 90x1 or 100x1 film-coated tablets in perforated unit dose blisters.
Maltese: Il-pilloli ta' Moventig 25 mg huma disponibbli f'folji tal-aluminju f'pakketti ta' 10, 30 jew 90 pillola miksija b'rita ġo folji mhux imtaqqba u pilloli miksijin b'rita ta' 10x1, 30x1, 90x1 jew 100x1 f'folji mtaqqba b'doża waħda.
English: Other medicines and Moventig
Maltese: Mediċini oħra u Moventig
English: Tabulated list of adverse reactions Adverse reactions are classified according to frequency and System Organ Class.
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont il-frekwenza u s-Sistema tal-Klassifika tal-Organi.
English: Oval, 10.5x5.5 mm, mauve tablet.
Maltese: 5x5.5 mm, ovali.
English: A potential CNS effect (reversal of opioid-induced miosis, as measured by pupillometry) was observed in 1 volunteer in the 250 mg group and 1 volunteer in the 1,000 mg group.
Maltese: Ġie osservat effett potenzjali fuq is-CNS (treġġigħ lura ta' mijosi minħabba l-opjojdi, kif imkejjel mill-pupillometrija) f'voluntier wieħed fil-grupp ta' 250 mg u voluntier wieħed fil-grupp ta' 1,000 mg.
English: In the pooled data from Kodiac 4 and Kodiac 5, responder rates in the LIR subgroup were 30.1% for placebo, 42.5% for the 12.5 mg dose, and 47.7% for the 25 mg dose, with the relative risk (95% CI) for treatment effect versus placebo of 1.410(1.106, 1.797) and 1.584(1.253, 2.001) for the 12.5 mg and 25 mg groups, respectively.
Maltese: 7 % għad-doża ta' 25 mg, bir-riskju relattiv (95 % CI) għall-effett tal-kura meta mqabbel mal-plaċebo ta' 1.410(1.106, 1.797) u 1.584(1.253, 2.001) għall gruppi ta' 12.5 mg u 25 mg, rispettivament.
English: For information regarding concomitant use with CYP3A4 inhibitors, see sections 4.2, 4.3 and 4.5.
Maltese: Għal informazzjoni dwar l-użu fl-istess ħin ma' inibituri tas-CYP3A4, ara sezzjonijiet 4.2, 4.3 u 4.5.
English: Patients with moderate or severe hepatic insufficiency (Child's-Pugh Class B or C) were excluded from the Phase III studies (Kodiac 4 and 5).
Maltese: Il-pazjenti b'insuffiċjenza tal-fwied moderata jew severa (Child Pugh Klassi B jew C) kienu esklużi mill-istudji tal-Fażi III (Kodiac 4 u 5).
English: EU/1/14/962/001 30 film-coated tablets EU/1/14/962/002 90 film-coated tablets EU/1/14/962/008 30 x 1 film-coated tablets (unit dose) EU/1/14/962/003 90 x 1 film-coated tablets (unit dose)
Maltese: EU/1/14/962/001 30 pilloli miksijin b'rita EU/1/14/962/002 90 pilloli miksijin b'rita EU/1/14/962/008 30 x 1 pilloli miksijin b'rita (doża waħda)
English: OTHER
Maltese: Il
English: In Kodiac 4, response rates in the placebo, 12.5 mg and 25 mg groups in the LIR subgroup were 28.8%, 42.6% and 48.7%, while in Kodiac 5, the corresponding response rates were 31.4, 42.4% and 46.8%.
Maltese: F'Kodiac 4, irrati ta' rispons fil-plaċebo, gruppi ta' 12.5 mg u 25 mg fis-sottogrupp LIR kienu ta' 28.8 %, 42.6 % u 48.7 %, filwaqt li f'Kodiac 5, ir-rati ta' rispons korrispondenti kienu ta' 31.4 %, 42.4 % u 46.8 %.
English: • if you are taking certain other medicines such as ketoconazole or itraconazole (to treat fungal infections), clarithromycin or telithromycin (antibiotics) or ritonavir, indinavir or saquinavir (to treat HIV).
Maltese: • jekk qed tieħu ċerti mediċini oħra bħal ketoconazole jew itraconazole (biex tikkura infezzjonijiet fungali), clarithromycin jew telithromycin (antibijotiċi) jew ritonavir, indinavir jew saquinavir (għall-kura tal-HIV).
English: It is a medicine used in adults to treat constipation specifically caused by pain medicines, called opioids, (e.g. morphine, oxycodone, fentanyl, tramadol, codeine) taken on a regular basis.
Maltese: Hija mediċina użata fl-adulti biex tikkura stitikezza ikkawżata speċifikament minn mediċini għall-uġigħ, li jissejħu opjojdi, (eż. morfina, oxycodone, fentanyl, tramadol, koedina) li jittieħdu fuq bażi regolari.
English: SBM was defined as a bowel movement without rescue laxative taken within the past 24 hours.
Maltese: SBM kien iddefenit bħala moviment talimsaren mingħajr lassattiv ta' għajnuna fl-aħħar 24 siegħa.
English: The 25 mg dose in the LIR subgroup improved rectal straining (Kodiac 4 p=0.043, Kodiac 5 p<0.001).
Maltese: Id-doża ta' 25 mg fis-sottogrupp LIR tejbet l-isforz tar-rektum (Kodiac 4 p=0.043, Kodiac 5 p<0.001).
English: EU/1/14/962/004 10 film-coated tablets EU/1/14/962/005 30 film-coated tablets EU/1/14/962/006 90 film-coated tablets EU/1/14/962/009 10 x 1 film coated tablets (unit dose) EU/1/14/962/010 30 x 1 film-coated tablets (unit dose) EU/1/14/962/007 90 x 1 film-coated tablets (unit dose) EU/1/14/962/011 100 x 1 film-coated tablets (unit dose)
Maltese: EU/1/14/962/004 10 pilloli miksijin b'rita EU/1/14/962/005 30 pilloli miksijin b'rita EU/1/14/962/006 90 pilloli miksijin b'rita EU/1/14/962/009 10 x 1 pilloli miksijin b'rita (doża waħda)
English: No dose adjustment is recommended based on age (see section 5.2).
Maltese: Ma huwa rrakkomandat ebda aġġustament skont l-età (ara sezzjoni 5.2).
English: Opioid withdrawal syndrome
Maltese: Sindromu tal-irtirar mill-opjojdi
English: None of the metabolites were present in > 10% of the plasma concentrations of parent or total parent and metabolite related material.
Maltese: L-ebda wieħed mill-metaboliti ma kien preżenti f'> 10% tal-konċentrazzjonijiet fil-plażma tal-materjal oriġinali jew relatat mal-materjal oriġinali u metabolit totali.
English: 10 film-coated tablets 30 film-coated tablets 90 film-coated tablets 10 x 1 film-coated tablets 30 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets
Maltese: 10 pilloli miksijin b'rita 30 pillola miksija b'rita 90 pillola miksija b'rita 10 x 1 pillola miksija b'rita 30 x 1 pillola miksija b'rita 90 x 1 pillola miksija b'rita 100 x 1 pillola miksija b'rita
English: Infections and Infestations
Maltese: Infezzjonijiet u Infestazzjonijiet
English: This medicine contains less than 1 mmol sodium (23 mg) per 12.5 mg / 25 mg tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull 12,5 mg / 25 mg pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Flatulence, nausea, vomiting
Maltese: żaqqa, dijarea
English: Naloxegol was not studied in the clinical trial programme in patients who had a recent history of myocardial infarction within 6 months, symptomatic congestive heart failure, overt cardiovascular (CV) disease or patients with a QT interval of ≥ 500 msec. Moventig should be used with caution in these patients.
Maltese: Naloxegol ma ġiex studjat fil-programm ta' provi kliniċi f'pazjenti li kellhom storja riċenti ta' infart mijokardiku fis-6 xhur preċedenti, insuffiċjenza sintomatika u konġestiva tal-qalb, mard kardjovaskulari (CV - cardiovascular) evidenti jew f'pazjenti b'intervall QT ta' ≥ 500 msec.
English: How to store Moventig
Maltese: X'fih Moventig
English: In an open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, single-dose, crossover study to evaluate the effect of multiple doses of rifampin on the single dose PK of naloxegol, coadministration of rifampin and naloxegol resulted in a 89% (90% CI: 88%-90%) decrease in naloxegol AUC and a 76% decrease in naloxegol Cmax (90% CI: 69%-80%), 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' rifampin fuq PK ta' doża waħda ta' naloxegol, l-għoti flimkien ta' rifampin ma' naloxegol irriżulta fi tnaqqis ta' 89% (90% CI: 88%-90%) fl-AUC ta'
English: Following oral administration of radiolabelled naloxegol, 68% and 16% of total administered dose were recovered in the faeces and urine, respectively.
Maltese: Wara l-għoti orali ta' naloxegol radjutikketjat, 68 % u 16 % tad-doża totali mogħtija kienu rkuprati flippurgar u fl-awrina, rispettivament.
English: • Pour the powder into half a glass of water (120 ml)
Maltese: • Ferra' t-trab ġo nofs tazza ilma (120 ml)
English: There is a small effect of age on the pharmacokinetics of naloxegol (approximately 0.7% increase in AUC for every year increase in age).
Maltese: Hemm effett żgħir tal-età fuq il-farmakokinetika ta' naloxegol (żieda ta' madwar 0.7 % fl-AUC għal kull żieda fis-sena fl-età).
English: Results from a QWBA (Quantitative Whole Body Autoradiography) study in the rat and the lack of antagonism of CNS opiate effects in humans at naloxegol doses less than 250 mg, indicate minimal distribution of naloxegol into the CNS.
Maltese: Ir-riżultati minn studju QWBA (Awtoradjografija tal-Piż tal-Ġisem Kwantitattiva) fil-far u n-nuqqas ta' antagoniżmu tal-effetti tal opjojdi tas-CNS fil-bnedmin f'dożi ta' naloxegol inqas minn 250 mg, jindikaw distribuzzjoni minima ta' naloxegol fis-CNS.
English: Pharmacotherapeutic group: Drugs for constipation, peripheral opioid receptor antagonists ATC code: A06AH03
Maltese: Mediċini għal stitikezza, antagonisti tar-riċettur tal-opjojdi periferali kodiċi ATC:
English: 30 film-coated tablets 90 film-coated tablets 30 x 1 film-coated tablets 90 x 1 film-coated tablets
Maltese: 30 pillola miksija b'rita 90 pillola miksija b'rita 30 x 1 pillola miksija b'rita 90 x 1 pillola miksija b'rita
English: Medicinal product subject to medical prescription
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Plasma protein binding of naloxegol in humans was low and the fraction unbound ranged from 80% to
Maltese: L-irbit tal-proteini fil-plażma ta' naloxegol fil-bnedmin kien baxx u l-frazzjoni mhux marbuta varjat minn 80 % sa 100 %.
English: The safety and efficacy of naloxegol in children <18 years of age has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' naloxegol fit-tfal <18 sena ma ġewx determinati s'issa.
English: These metabolites represented more than 32% of the administered dose and were formed via N-dealkylation, O-demethylation, oxidation and partial loss of the PEG chain.
Maltese: Dawn il-metaboliti rrappreżentaw aktar minn 32 % tad-doża mogħtija u ġew iffurmati permezz ta' N-dealkylation, O-demethylation, l-ossidazzjoni u t-telf parzjali tal-katina PEG.
English: In Kodiac 4, placebo, 12.5 mg and 25 mg dose had median time to first post dose SBM of 43.4, 20.6, and 5.4 hours, respectively.
Maltese: F'Kodiac 4, plaċebo, doża ta' 12.5 mg u doża ta' 25 mg kellhom ħin medju għall-ewwel SBM ta' wara d-doża ta' 43.4, 20.6, u 5.4 sigħat, rispettivament.
English: • if you have kidney problems
Maltese: • jekk għandek problemi fil-kliewi
English: The LIR subgroup symptom responder rates in Kodiac 4 for placebo, 12.5 mg and 25 mg arms were 24.6%, 36.5% and 45.3% and the symptom responder rates in Kodiac 5 were 25.6%, 33.6% and 42.7%.
Maltese: Ir-rati tar-responder tas-sintomi tassottogrupp LIR f'Kodiac 4 għal gruppi ta' plaċebo, 12.5 mg u 25 mg kienu 24.6 %, 36.5 % u 45.3 % u r-rati tar-responder tas-sintomi f'Kodiac 5 kienu ta' 25.6
English: OIC was confirmed through a two week run in period and defined as < 3 spontaneous bowel movements (SBMs) per week on average with constipation symptoms associated with at least 25% of bowel movements.
Maltese: L-OIC kienet ikkonfermata permezz ta' perjodu ta' bidu ta' ġimagħtejn u ddefinita bħala < 3 movimenti tal-imsaren spontanji (SBMs) fil-ġimgħa bħala medja b'sintomi ta' stitikezza assoċjati ma' tal-anqas 25 % tal-movimenti tal-imsaren.
English: To qualify as LIR, in the two weeks prior to first study visit patients had to have reported concurrent OIC symptoms of at least moderate severity while taking at least one laxative class for a minimum of four days during the pre study period.
Maltese: OIC konkurrenti ta' mill-inqas severità moderata filwaqt li jieħdu tal-anqas klassi ta' lassattivi waħda għal minimu ta' erbat ijiem matul il-perjodu ta' qabel l-istudju.
English: Exposure of naloxegol in end-stage renal disease (ESRD) patients on haemodialysis was similar to healthy volunteers with normal renal function.
Maltese: L-esponiment ta' naloxegol fil-pazjenti b'mard fil-fwied fl-istadju finali (ESRD) fuq emodijalisi kien simili għal voluntiera b'saħħithom b'funzjoni tal-fwied normali.
English: In the 12-week studies (Kodiac 4 and 5), the frequency of back pain AEs was 4.3% for naloxegol 25 mg versus 2.0% for placebo, and the frequency of extremity pain AEs was 2.2% for naloxegol 25 mg, versus 0.7% for placebo.
Maltese: Fl-istudji ta' 12-il ġimgħa (Kodiac 4 u 5), il-frekwenza ta' Aes (episodji avversi) ta' uġigħ fid-dahar kienet 4.3% għal naloxegol 25 mg meta mqabbla ma' 2.0% għall-plaċebo, u l-frekwenza ta' AEs ta' uġigħ fl-estremitajiet kienet ta' 2.2% għal naloxegol 25 mg, meta mqabbla ma' 0.7% għall-plaċebo.
English: As renal clearance is a minor route of elimination for naloxegol, regardless of severity (i.e. moderate, severe and end stage renal failure), the impact of renal impairment on the pharmacokinetics of naloxegol was minimal in most subjects.
Maltese: Peress li t-tneħħija permezz tal-kliewi hija rotta minuri ta' eliminazzjoni għal naloxegol, irrispettivament mis-severità (jiġifieri insuffiċjenza renali moderata, severa u fl-istadju finali), l-impatt tal-indeboliment tal-kliewi fuq il-farmakokinetika ta' naloxegol kien minimu fil-biċċa l-kbira talindividwi.
English: In a long-term safety study (Kodiac 8), the frequency of AE reports of back pain was 8.9% for naloxegol 25 mg versus 8.8% for usual care.
Maltese: Fi studju fit-tul tas-sigurtà (Kodiac 8), il-frekwenza ta' rapporti AE ta' uġigħ fid-dahar kienet ta' 8.9%
English: In a mass balance study in humans, a total of 6 metabolites were identified in plasma, urine and faeces.
Maltese: Bijotrasformazzjoni Fi studju tal-bilanċ tal-massa fil-bnedmin, ġie identifikat total ta' 6 metaboliti fil-plażma, l-awrina u l ippurgar.
English: As the effects of P-gp inhibitors on the PK of naloxegol were small relative to the effects CYP3A4 inhibitors, the dosing recommendations for Moventig when co-administered with medicinal products causing both P-gp and CYP3A4 inhibition should be based on CYP3A4 inhibitor status - strong, moderate or weak (see sections 4.2, 4.3 and 4.5).
Maltese: Minħabba li l-effetti ta' inibituri ta' P-gp fuq il-PK ta' naloxegol kienu żgħar meta mqabbla mal-effetti ta' inibituri ta' CYP3A4, ir-rakkomandazzjonijiet ta' dożaġġ għal Moventig meta jingħata flimkien mal-prodotti mediċinali li jikkawżaw kemm inibizzjoni għal P-gp kif ukoll CYP3A4 għandhom ikunu bbażati fuq l-istatus tal-inibitur CYP3A4 qawwi, moderat, ħafif (ara sezzjonijiet 4.2, 4.3 u 4.5).
English: Moventig 12.5 mg tablets are available in aluminium blisters in pack sizes of 30 or 90 film-coated tablets in non-perforated blisters and 30x 1 or 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: Il-pilloli ta' Moventig 12.5 mg huma disponibbli f'folji tal-aluminju f'pakketti ta' 30 jew 90 pillola miksija b'rita ġo folji mhux imtaqqba u pilloli miksijin b'rita ta' 30x1 jew 90x1 f'folji mtaqqba b'doża waħda.
English: Moventig 12.5 mg film-coated tablet (tablet).
Maltese: Moventig 12.5 mg pillola miksija b'rita (pillola).