FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from 133 (62 methylnaltrexone bromide, 71 placebo) patients were analysed.
Maltese: Ġie analizzat tagħrif minn 133 (62 methylnaltrexone bromide, 71 plaċebo) pazjent.
English: Pharmacotherapeutic group: Laxatives, Peripheral opioid receptor antagonists, ATC code: A06AH01
Maltese: Porog, Antagonisti riċettaturi ta' opijojdi periferali, Kodiċi ATC:
English: Methylnaltrexone bromide is minimally bound to human plasma proteins (11.0 % to 15.3 %) as determined by equilibrium dialysis.
Maltese: Methylnaltrexone bromide jintrabat mill-inqas mal proteini tal-plażma tal-bniedem (11.0 % sa 15.3 %) kif stabbilit b'dijaliżi ta' ekwilibriju.
English: Not known: Gastrointestinal perforation (see section 4.4)
Maltese: Perforazzjoni gastrointestinali (ara sezzjoni 4.4)
English: What Relistor contains - The active substance is methylnaltrexone bromide.
Maltese: X'fih Relistor - Is-sustanza attiva hi methylnaltrexone bromide.
English: Tel. +36 1 998 99 47 e-mail: mail.hu@sobi.com
Maltese: +36 1 998 99 47 e-mail: mail.hu@sobi.com
English: Pack sizes of 4, 7, 8 and 10 pre-filled syringes.
Maltese: Daqsijiet tal-pakkett ta' 4, 7, 8 u 10 siringi mimlijin għal-lest.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM < PC:
English: 18 months
Maltese: 39 jum).
English: In adult and juvenile dogs given methylnaltrexone bromide at 20 mg/kg/day, clinical signs indicative of CNS toxicity and prolongation of QTc interval were observed.
Maltese: Fi klieb adulti u fi klieb għadhom żgħar mogħtija methylnaltrexone bromide f'20 mg/kg/kuljum, ġew osservati sinjali kliniċi indikattivi tat-tossiċità fis-CNS u prolungament tal-intervall QTc.
English: In vitro metabolism studies suggest that methylnaltrexone bromide does not inhibit the activity of CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 or CYP3A4, while it is a weak inhibitor of the metabolism of a model CYP2D6 substrate.
Maltese: Methylnaltrexone bromide huwa metabolizzat mill-inqas b'isoenzimi CYP. Studji in vitro dwar il-metaboliżmu jissuġġerixxu li methylnaltrexone bromide ma jimpedixxix l-attività ta' CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19
English: The adverse reactions are classified as: very common (≥1/10); common (≥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: Ir-reazzjonijiet avversi huma klassifikati bħala: 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 jistax jiġi stmat mit-tagħrif disponibbli).
English: A total of 154 patients (methylnaltrexone bromide 0.15 mg/kg, n = 47; methylnaltrexone bromide 0.3 mg/kg, n = 55, placebo, n = 52) were treated in the double-blind period.
Maltese: Total ta' 154 pazjent (methylnaltrexone bromide 0.15 mg/kg, n = 47, methylnaltrexone bromide 0.3 mg/kg, n = 55, plaċebo, n = 52) kienu trattati fil perijodu double-blind.
English: The renal clearance of methylnaltrexone bromide was reduced following multiple-dose administration of cimetidine (from 31 L/h to 18 L/h).
Maltese: It-tneħħija mill-kliewi ta' methylnaltrexone bromide tnaqqset wara l għoti f'dożi multipli ta' cimetidine (minn 31 l/h sa 18 l/h).
English: Sodium chloride Sodium calcium edetate Glycine hydrochloride
Maltese: Sodium chloride Sodium calcium edetate Glycine hydrochloride Ilma għall-injezzjonijiet
English: For storage conditions of the medicinal product in the syringe, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali fis-siringa, ara sezzjoni 6.3.
English: Methylnaltrexone bromide is eliminated primarily as the unchanged active substance.
Maltese: Methylnaltrexone bromide jiġi eliminat primarjament bħala s-sustanza attiva mhux mibdula.
English: Carefully pull back the plunger on the syringe to either the 0.4 mL mark for 8 mg of Relistor or the 0.6 mL mark for 12 mg Relistor.
Maltese: Iġbed il-planġer tas-siringa lura jew għall-marka ta' 0.4 mL għal 8 mg ta' Relistor jew għall-marka 0.6 mL għal 12 mg Relistor.
English: The mean steady-state Cmax and AUC for the elderly were 545 ng/mL and 412 ng•h/mL, approximately 8.1 % and 20 %, respectively, greater than those for young subjects.
Maltese: L-istat fiss medju Cmax u AUC għall-anzjani kienu 545 ng/mL u 412 ng·h/mL, madwar 8.1 %
English: The mean methylnaltrexone bromide exposure at 0.15 mg/kg over a weight range of 38 to 114 kg was 179 (range = 139-240) ng•h/mL.
Maltese: 38 sa 114 kg kienet ta' 179 (firxa ta' = 139-240) ng•h /mL.
English: In juvenile rats administered intravenous methylnaltrexone bromide for 13 weeks, adverse clinical signs (incidences of convulsions and labored breathing) occurred at dosages (≥ 3 mg/kg/day) and exposures (5.4 times the exposure {AUC} in adult humans at a subcutaneous dose of 0.15 mg/kg) that were lower than those that caused similar toxicity in adult rats (20 mg/kg/day).
Maltese: F'firien għadhom żgħar mogħtija methylnaltrexone bromide ġol-vini għal 13-il ġimgħa, seħħew sinjali kliniċi avversi (inċidenzi ta' konvulżjonijiet u diffikultà fit-teħid tan-nifs) f'dożaġġi (≥ 3 mg/kg/kuljum) u espożizzjonijiet (5.4 drabi l-espożizjoni {AUC} f'adulti umani f'doża taħt ilġilda ta' 0.15 mg/kg) li kienu inqas minn dawk li kkawżaw tossiċità simili f'firien adulti (20 mg/kg/kuljum).
English: Absolute bioavailability of a 0.30 mg/kg subcutaneous dose versus a 0.30 mg/kg intravenous dose is 82 %.
Maltese: Il bijodisponibilità assoluta ta' doża taħt il-ġilda ta' 0.30 mg/kg kontra doża ta' 0.30 mg/kg li tingħata ġol-vina hija ta' 82 %.
English: In addition, the analysis showed that 8 mg dose for body weight 38 to less than 62 kg and a 12 mg dose for body weight 62 to 114 kg correspond to mean doses of 0.16 (range = 0.21-0.13) mg/kg and 0.16 (range = 0.19-0.11) mg/kg, respectively, based on the body weight distribution of patients participating in studies 301 and 302.
Maltese: 62 sa 114 kg jikkorispondu għal dożi medji ta' 0.16 (firxa = 0.21-0.13) mg/kg u 0.16 (firxa = 0.190.11) mg/kg, rispettivament, skont id-distribuzzjoni tal-piż tal-ġisem ta' pazjenti li pparteċipaw flistudji 301 u 302.
English: In a double-blind, randomised, parallel-group ECG study of single, subcutaneous doses of methylnaltrexone bromide (0.15, 0.30 and 0.50 mg/kg), in 207 healthy volunteers, no signal of QT/QTc prolongation or any evidence of an effect on secondary ECG parameters or waveform morphology was detected as compared to placebo and a positive control (orally administered 400 mg moxifloxacin).
Maltese: Fi studju double-blind, randomizzat ta' l-ECG fuq grupp parallel f'207 voluntier b'saħħtu, li ngħataw doża waħda taħt il-ġilda ta' methylnaltrexone bromide (0.15, 0.30 u 0.50 mg/kg), ma kien hemm ebda sinjal ta' titwil ta' QT/QTc jew evidenza oħra fuq parametri sekondarji ta' l-ECG jew morfoloġija fuq il-waveform ma ġie indikat meta mqabbel ma' plaċebo jew kontroll pożittiv (400 mg moxifloxacin mogħti mill-ħalq).
English: A total of 460 patients (methylnaltrexone bromide
Maltese: Total ta' 154 pazjent (methylnaltrexone bromide
English: Sodium hydroxide (to adjust pH)
Maltese: Sodium hydroxide (biex jaġġusta l-pH)
English: However, this resulted in a small reduction in total clearance (from 107 L/h to 95 L/h).
Maltese: Madankollu dan jirriżulta fi tnaqqis zgħir mit-tneħħija totali (minn 107 l/h sa 95 l/h).
English: The difference between methylnaltrexone bromide 12 mg once daily and placebo of 1.6 RFBMs per week is statistically significant (p < 0.001) and clinically meaningful.
Maltese: Id-differenza ta' 1.6 RFBMs fil-ġimgħa bejn methylnaltrexone bromide 12 mg darba kuljum u plaċebo kien statistikament sinifikanti (p < 0.001) u klinikament notevoli.
English: Conversion to methyl-6-naltrexol isomers and methylnaltrexone sulphate appears to be the primary pathway to metabolism.
Maltese: Il-konverżjoni għal iżomeri ta' methyl-6-naltrexol u methylnaltrexone sulphate tidher li hija l-passaġġ primarju għall-metaboliżmu.
English: In a study of volunteers with varying degrees of renal impairment receiving a single dose of 0.30 mg/kg methylnaltrexone bromide, renal impairment had a marked effect on the renal excretion of methylnaltrexone bromide.
Maltese: Fi studju ta' voluntieri bi gradi differenti ta' indeboliment renali li rċevew doża waħda ta' 0.30 mg/kg methylnaltrexone bromide, l-indeboliment renali kellu effett notevoli fuq l-eliminazzjoni mill-kliewi ta' methylnaltrexone bromide.
English: The effect on race could not be analysed because the study population was predominantly Caucasian (90 %).
Maltese: L-effett fuq ir-razza ma setgħax jiġi analizzat għax il-popolazzjoni kienet prinċipalment Kawkasi (90%).
English: In vitro studies have shown methylnaltrexone bromide to be a mu-opioid receptor antagonist (inhibition constant [Ki] = 28 nM), with 8-fold less potency for kappa opioid receptors (Ki = 230 nM) and much reduced affinity for delta opioid receptors.
Maltese: Studji in vitro wrew li methylnaltrexone bromide huwa riċettatur antagonista ta' mu-opjojdi (konstant ta' l inibizzjoni [Ki] = 28 nM), b'potenza ta' 8 darbiet inqas għal riċettaturi opjojdi kappa (Ki = 230 nM) ub'affinità mnaqqsa ħafna għal riċettaturi opjojdi delta.
English: Severe renal impairment decreased the renal clearance of methylnaltrexone bromide by 8- to 9-fold; however, this resulted in only a 2-fold increase in total methylnaltrexone bromide exposure (AUC).
Maltese: methylnaltrexone bromide bi 8 sa 9 darbiet; madankollu dan irriżulta f'żieda ta' darbtejn flespożizzjoni totali għal methylnaltrexone bromide (AUC).
English: The mechanism of this effect is unknown; however, the human cardiac potassium ion channel (hERG) appears not to be involved.
Maltese: Il-mekkaniżmu ta' dan l-effett mhuwiex magħruf; madankollu l-kanal kardijaku uman għall-joni tal-potassium (hERG) ma jidhirx li hu involut.
English: A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/kg administered as an intravenous bolus.
Maltese: Studju ta' voluntieri b'saħħithom innota ipotensjoni ortostatika assoċjata ma' doża ta' 0.64 mg/kg mogħtija bħala bolus ghal ġol-vini.
English: A total of 460 patients (methylnaltrexone bromide 12 mg once daily, n=150, methylnaltrexone bromide 12 mg every other day, n=148, placebo, n=162) were treated in the double-blind period.
Maltese: Total ta' 460 pazjent (methylnaltrexone bromide 12 mg darba kuljum, n=150, methylnaltrexone bromide 12 mg darba iva darba le, n =148, plaċebo n=162) kienu trattati fil-perijodu double-blind.
English: Solution for injection.
Maltese: ttemm l-injezzjoni.
English: Methylnaltrexone bromide undergoes moderate tissue distribution.
Maltese: Methylnaltrexone bromide jgħaddi minn firxa moderata fit-tessuti.
English: Methylnaltrexone bromide is metabolised to a modest extent in humans based on the amount of methylnaltrexone bromide metabolites recovered from excreta.
Maltese: Methylnaltrexone bromide huwa metabolizzat b'mod modest fil-bniedem skont l-ammont ta' metaboliti ta' methylnaltrexone bromide rkuprati mill-ippurgar.
English: Sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH).
Maltese: Sodium chloride, sodium calcium edetate, glycine hydrochloride, ilma għall-injezzjonijiet, hydrochloric acid (biex jaġġusta l-pH), sodium hydroxide (biex jaġġusta l-pH).
English: Other medicines and Relistor
Maltese: Mediċini oħra u Relistor
English: 1 vial of 0.6 mL
Maltese: Kunjett 1 ta' 0.6 mL
English: Relistor 12 mg/0.6 mL solution for injection Methylnaltrexone bromide
Maltese: Relistor 12 mg/0.6 mL soluzzjoni għall-injezzjoni Methylnaltrexone bromide
English: Cases of GI perforation have been reported in the postauthorisation period after use of methylnaltrexone bromide in patientswith conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, pseudo obstruction (Ogilvie's syndrome), diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases).
Maltese: Każijiet ta' perforazzjoni gastrointestinali (GI) ġew irrapportati fil-perjodu ta' wara l-awtorizzazzjoni wara l-użu ta' methylnaltrexone bromide f'pazjenti b'kundizzjonijiet li jistgħu jkunu assoċjati ma' tnaqqis lokalizzat jew diffuż ta' integrità strutturali fil-ħajt tal-passaġġ gastrointestinali (eż., il-marda tal-ulċera peptika , psewdo-ostruzzjoni (is-sindromu ta' Ogilvie), marda divertikulari, tumuri talpassaġġ gastrointestinali infiltrattivi jew metastasi peritoneali).
English: Slovenská republika Swedish Orphan Biovitrum o.z.
Maltese: Luxembourg/Luxemburg Swedish Orphan Biovitrum BVBA
English: Data from clinical trials suggest treatment with methylnaltrexone bromide can result in the rapid onset (within 30 to 60 minutes on average) of a bowel movement.
Maltese: Tagħrif minn provi kliniċi jissuġġerixxi li t-trattament b'methylnaltrexone bromide jista' jikkaġuna bidu rapidu (fi żmien medju ta' bejn 30 u 60 minuta) fl-imsaren.
English: Each syringe of 0.4 mL contains 8 mg methylnaltrexone bromide.
Maltese: Kull siringa ta' 0.4 mL fiha 8 mg methylnaltrexone bromide.
English: No adverse effects occurred in juvenile rats at 1 mg/kg/day or in adult rats at 5 mg/kg/day (1.6 times and 7.8 times, respectively, the exposure {AUC} in adult humans at a subcutaneous dose of 0.15 mg/kg).
Maltese: Ma seħħ ebda effett avvers f'firien għadhom żgħar f'1 mg/kg/kuljum jew f'firien adulti f'5 mg/kg/kuljum (1.6 drabi u 7.8 drabi, rispettivament, l-espożizzjoni {AUC} f'adulti umani f'doża taħt il-ġilda ta' 0.15 mg/kg).
English: Step 4a: Injecting Relistor using a pack containing injection syringe with retractable injection needle Step 4b: Injecting Relistor using a standard injection syringe and injection needle Step 5 Disposing of supplies
Maltese: Pass 4b: Kif tinjetta Relistor permezz ta' siringa ta' l-injezzjoni u labra ta' l-injezzjoni standard Pass 5:
English: Doses up to 25 mg/kg/day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/kg) did not affect fertility or general reproductive performance.
Maltese: Dożi sa 25 mg/kg/jum (18-il darba l-esponiment [AUC] fil-bniedem f'doża taħt il-ġilda ta' 0.3 mg/kg) ma affettwax il-fertilità jew il-prestazzjoni riproduttiva ġenerali.
English: Each vial contains 0.6 mL of solution.
Maltese: Kull kunjett fih 0.6 mL ta' soluzzjoni.
English: N-demethylation of methylnaltrexone bromide to produce naltrexone is not significant, accounting for 0.06 % of the administered dose.
Maltese: N-demethylation ta' methylnaltrexone bromide sabiex tipproduċi naltrexone mhijiex sinifikanti, li tgħodd għal 0.06 % tad-doża mogħtija.
English: Paediatric population No studies have been performed in the paediatric population (see section 4.2).
Maltese: L-ebda studju ma twettaq fil-popolazzjoni ta' tfal (ara sezzjoni 4.2).
English: In this study, the median patient age was 49 years (range 23-83); 60% were females.
Maltese: 23-83); 60% kienu nisa.
English: • If you have Crohn´s disease or gastrointestinal ulcers
Maltese: • Jekk għandek il-marda ta' Crohn jew ulċeri gastro-intestinali.
English: The key secondary endpoint of adjusted mean change from baseline in weekly RFBMs was 3.1 in the methylnaltrexone bromide 12 mg once daily treatment group, 2.1 in the methylnaltrexone bromide 12 mg every other day treatment group, and 1.5 in the placebo treatment group during the 4-week double-blind period.
Maltese: Il-punt aħħari sekondarju ewlieni ta' bidla fil-medja aġġustata mil-linja bażi f'RFBN ta' kull ġimgħa kien ta' 3.1 fil-grupp li ngħata methylnaltrexone bromide 12 mg darba kuljum, 2.1 fil-grupp li ngħata methylnaltrexone bromide 12 mg ġurnata iva u ġurnata le, u 1.5 fil-grupp ta' trattament bil-plaċebo matul il-perijodu double-blind ta' 4 ġimgħat.
English: This was achieved in 28.7% of the patients in the group receiving daily methylnaltrexone 12 mg (p<0.001 vs. placebo), in 14.9% of those receiving it every other day (p=0.012 vs. placebo), and in 6.2% of the placebo treated patients.
Maltese: 001 vs. plaċebo), f'14.9% ta' dawk li ħaduh ġurnata iva u ġurnata le (p=0.012 vs. plaċebo), u f'6.2% ta' pazjenti trattati bi plaċebo.
English: The organic cation transporter (OCT)-related drug-drug interaction potential between methylnaltrexone bromide and an OCT inhibitor was studied in 18 healthy subjects by comparing the single-dose pharmacokinetic profiles of methylnaltrexone bromide before and after multiple 400 mg doses of cimetidine.
Maltese: bejn methylnaltrexone bromide u impeditur OCT ġie studjat fi 18-il pazjent b'saħħithom billi tqabblu l-profili farmakokinetiċi ta' doża waħda ta' methylnaltrexone bromide qabel u wara li ngħataw dożi multipli ta' 400 mg cimetidine.
English: The mean percentage of methylnaltrexone bromide resulting in any RFBM within 4 hours were 28.9% and 30.2% respectively for the once daily and every other day dose groups compared with 9.4% and 9.3% respectively for the corresponding placebo regimen for daily and every other day dosing (p <0.001) during the double blind phase.
Maltese: Il-perċentwali medja ta' methylnaltrexone bromide li tirriżulta minn RFBM fi żmien 4 sigħat kienet ta' 28.9% u 30.2% rispettivament għal gruppi ta' dawk li kienu jieħdu d-doża tagħhom kuljum jew ġurnata iva u ġurnata le meta mqabbla ma' 9.4% u 9.3% rispettivament għal trattament korrispondenti ta' plaċebo(p < 0.001).
English: SC
Maltese: Sess
English: The recommended dose for patients receiving supportive care in advanced illness is 8 mg methylnaltrexone bromide (0.4 mL of solution) for patients weighing 38-61 kg or 12 mg (0.6 mL of solution) for patients weighing 62-114 kg.
Maltese: Id-doża rakkomandata ta' methylnaltrexone bromide hi ta' 8 mg (0.4 mL ta' soluzzjoni) (għal pazjenti li jiżnu 38-61 kg) jew 12 mg (0.6 mL ta' soluzzjoni) (għal pazjenti li jiżnu bejn 62-114 kg).
English: During the first week (days 1, 3, 5, 7), patients received either methylnaltrexone bromide 0.15 mg/kg or placebo.
Maltese: Matul l-ewwel ġimgħa (jiem 1, 3, 5, 7), il-pazjenti rċevew 0.15 mg/kg methylnaltrexone bromide jew plaċebo.
English: Study 3356 compared 4-week treatment regimens of methylnaltrexone bromide 12 mg once daily and methylnaltrexone bromide 12 mg every other day with placebo.
Maltese: L-istudju 3356 qabbel programmi ta' trattament ta' 4 ġimgħat ta' methylnaltrexone bromide 12 mg darba kuljum u methylnaltrexone bromide 12 mg li ngħata darba iva u darba le ma' plaċebo.
English: The efficacy and safety of methylnaltrexone bromide were also demonstrated in open-label treatment administered from Day 2 through Week 4 in Study 301, and in two open-label extension studies (301EXT and 302EXT) in which methylnaltrexone bromide was given as needed for up to 4 months (only 8 patients up to this point).
Maltese: L-effikaċja u s-sigurtà ta' methylnaltrexone bromide intwerew ukoll fi trattament open label mogħti minn Jum 2 sa Ġimgha 4 fi Studju 301, u f'żewġ studji ta' estensjoni b'open label (301EXT u 302EXT) meta methylnaltrexone bromide ngħata kif meħtieġ għal sa 4 xhur (s'issa 8 pazjenti biss).
English: This exposure for the 0.15 mg/kg dose can be achieved with a weight-bandbased dose adjustment using an 8 mg dose for body weight 38 to less than 62 kg and a 12 mg dose for body weight 62 to 114 kg, yielding a mean exposure of 187 (range = 148-220) ng•h/mL.
Maltese: 0.15 mg/kg tista' tintlaħaq b'faxxa ta' piżijiet ibbażati skont l-aġġustament tad-doża billi tintuża doża ta' 8 mg għal piż tal-ġisem ta' 38 sa inqas minn 62 kg u doża ta' 12 mg għal piż tal-ġisem ta' 62 sa 114 kg, li jrendi espożizzjoni medja ta' 187 (firxa =148-220) ng•h/mL.
English: • Dizziness (light-headed)
Maltese: • Dijarea (tipporga maħlul spiss)
English: Not known: Gastrointestinal perforation (see section 4.4) Common: Vomiting
Maltese: Perforazzjoni gastrointestinali (ara sezzjoni 4.4),
English: The renal clearance of methylnaltrexone bromide decreased with increasing severity of renal impairment.
Maltese: It-tneħħija mill-kliewi ta' methylnaltrexone bromide tnaqqset b'żieda fis-severità ta' l-indeboliment renali.
English: Step 4b: Injecting Relistor using a standard injection syringe and injection needle
Maltese: Pass 4b: Kif tinjetta Relistor permezz ta' siringa ta' l-injezzjoni u labra ta' l-injezzjoni standard
English: Opioid-induced constipation in adult patients with chronic non-cancer pain (12 mg dose) The efficacy and safety of methylnaltrexone bromide in the treatment of opioid-induced constipation in patients with chronic non-cancer pain were demonstrated in a randomized, double-blind, placebo-controlled study (Study 3356).
Maltese: Stitikezza mqanqla minn opijojdi f'pazjenti adulti b'uġigħ kroniku mhux ta' kanċer (doża ta' 12 mg) L-effikaċja u s-sigurtà ta' methylnaltrexone bromide fit-trattament ta' stitikezza ikkaġunata minħabba opijojdi f'pazjenti b'uġigħ kroniku mhux ta' kanċer intwera fi studju każwali, double-blind,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT (PRE-FILLED SYRINGE PRESENTATION)
Maltese: Dardir (tħossok imdardar) Dijarea (tipporga maħlul spiss)
English: One mL of solution contains 20 mg methylnaltrexone bromide.
Maltese: Millilitru ta' soluzzjoni fih 20 mg methynaltrexone bromide.
English: • It is important to be near a toilet with assistance available if necessary, since bowel movement may happen within 30 minutes after injection of the medicine.
Maltese: • Huwa importanti li tkun qrib tojlit bl-assistenza disponibbli jekk ikun hemm bżonn, minħabba li l-ippurgar jista' jseħħ fi żmien 30 minuta minn wara li tingħata l-injezzjoni tal-mediċina.
English: Relistor pre-filled syringe Alcohol swab Cotton ball or gauze Adhesive plaster
Maltese: Relistor siringa mimlija għal-lest Imselħa ta' l-alkoħol Biċċa tajjara jew garża Stikk li teħel
English: The effect of mild and moderate hepatic impairment on the systemic exposure to methylnaltrexone bromide has been studied in 8 subjects each, with Child-Pugh Class A and B, compared to healthy subjects.
Maltese: L-effett ta' indeboliment epatiku ħafif u moderat fuq l-espożizzjoni sistematika ta' methylnaltrexone bromide ġie studjat fi 8 individwi kull wieħed minnhom, b'Child-Pugh ta' Klassi A u B, meta mqabblin ma' individwi b'saħħithom.
English: In a clinical drug interaction study in healthy adult male subjects, a subcutaneous dose of 0.3 mg/kg of methylnaltrexone bromide did not significantly affect the metabolism of dextromethorphan, a CYP2D6 substrate.
Maltese: Fi studju dwar l-effett tal-mediċina jew ta' affarijiet oħrajn fuq l-effett farmaċewtiku f'individwi rġiel adulti, doża ta' 0.3 mg/kg ta' methylnaltrexone bromide mogħtija taħt il-ġilda m'affettwatx b'mod sinifikanti l-metaboliżmu ta' dextromethorphan, substrat ta' CYP2D6.
English: Each syringe of 0.6 mL contains 12 mg methylnaltrexone bromide.
Maltese: Kull siringa ta' 0.6 mL fiha 12 mg methylnaltrexone bromide.
English: • Abdominal pain (belly ache)
Maltese: • Uġigħ addominali (uġigħ fl-istonku)
English: 0.6 mL (12 mg) More than 114 kg 0.15 mg/kg
Maltese: 0.6 mL (12 mg)
English: In palliative care patients, Relistor is added to usual laxative treatment (see section 5.1).
Maltese: F'pazjenti bi trattament maħsub biex inaqqas l-uġigħ, Relistor jiġi miżjud mat-trattament ta' porog li s-soltu jingħata (ara sezzjoni 5.1).
English: The proportion of patients having an RFBM within 4 hours of the first dose was 34.2% in the combined methylnaltrexone bromide group versus 9.9% in the placebo group (p<0.001).
Maltese: Il-proporzjon ta' pazjenti li kellhom RFBM fi żmien 4 sigħat mill-ewwel doża kien ta' 34.2 fil-grupp ikkombinat ta' methylnaltrexone bromide meta mqabbel ma' 9.9% fil-grupp tal-plaċebo (p<0.
English: water for injections, hydrochloric acid (to adjust pH) and sodium hydroxide (to adjust pH).
Maltese: hydrochloric acid (biex jaġġusta l-pH), sodium hydroxide (biex jaġġusta l-pH).
English: The following packs are available:
Maltese: Mhux magħruf: