FrancophonIA/ELRC3.0 huggingface dataset:
English: Consequently, no meaningful change in AUC of methylnaltrexone bromide, in addition to Cmax, was observed before and after multiple-dose administration of cimetidine.
Icelandic: Af þessum sökum sást engin mikilvæg breyting á AUC metýlnaltrexónbrómíðs, né Cmax, eftir gjöf endurtekinna skammta af címetidíni.
English: NEVER recap the needle.
Icelandic: ALDREI skal setja hlífina aftur á nálina.
English: What Relistor looks like and contents of the pack
Icelandic: Útlit Relistor og pakkningastærðir
English: Methylnaltrexone bromide should not be used during pregnancy unless clearly necessary.
Icelandic: Ekki má nota metýlnaltrexónbrómíð á meðgöngu nema brýna nauðsyn beri til.
English: Τηλ: +39 02 828 77 050 e-mail: mail.it@sobi.com
Icelandic: +39 02 828 77 050 e-mail: mail.it@sobi.com
English: Pharmacotherapeutic group: Laxatives, Peripheral opioid receptor antagonists, ATC code: A06AH01
Icelandic: Ópíóíð blokkar með útlæga verkun, ATC flokkur:
English: Glycine hydrochloride
Icelandic: Glýsín hýdróklóríð
English: Do not touch this area again before giving the injection.
Icelandic: SVÆÐI EKKI AFTUR ÁÐUR EN ÞÚ SPRAUTAR ÞIG.
English: In patients with severe renal impairment (creatinine clearance less than 30 mL/min), the dose of methylnaltrexone bromide should be reduced from 12 mg to 8 mg (0.4 mL of solution) for those weighing 62 to 114 kg.
Icelandic: Hjá sjúklingum með verulega skerðingu á nýrnastarfsemi (kreatínín úthreinsun minni en 30 ml/mín.), skal minnka skammt metýlnaletrexónbrómíðs úr 12 mg í 8 mg (0,4 ml af lausn) fyrir þá sem vega 62 til 114 kg.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection.
Icelandic: LYFJAFORM OG INNIHALD Stungulyf, lausn.
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 (p < 0.001).
Icelandic: Meðalprósenta RFBM innan 4 klukkustunda frá gjöf metýlnaltrexónbrómíðs var 28,9% hjá þeim sem fengu lyfið einu sinni á dag og 30,2% hjá þeim sem fengu lyfið annan hvern dag, samanborið við 9,4% og 9,3% fyrir samsvarandi lyfleysuhópa (p< 0,001).
English: After the needle is inserted, let go of the skin and slowly push the plunger all the way down to inject Relistor.
Icelandic: Eftir að þú hefur stungið nálinni í húðina, átt þú að sleppa takinu á húðinni og þrýsta stimplinum rólega alla leið niður til þess að sprauta Relistor.
English: In addition, median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebotreated patients.
Icelandic: Auk þess var ekki mikilvægur munur á miðgildi daglegs skammts af ópíóíðum, hvorki hjá sjúklingum sem fengu meðferð með metýlnaltrexónbrómíði né þeim sem fengu lyfleysu.
English: 2 sterile 1 mL injection syringes with retractable injection needle 4 alcohol swabs
Icelandic: 2 sæfðar 1ml sprautur til inndælingar með inndraganlegi nál 4 sprittþurkur
English: Patient weight in kg Fill syringe to mL level (dose) Less than 38 kg
Icelandic: Þyngd sjúklings í kg Fyllið sprautuna að ml merki (skammtur)
English: The double-blind dose was followed by an open-label, 4-week dosing period, where methylnaltrexone bromide could be used as needed, no more frequently than 1 dose in a 24-hour period.
Icelandic: Eftir að skammturinn hafði verið gefinn, tvíblint, var honum fylgt eftir með opinni 4-vikna rannsókn þar sem nota mátti metýlnaltrexónbrómíð eftir þörfum, en þó ekki meira en einn skammt á sólarhring.
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 doubleblind period.
Icelandic: Lykilaukaendapunktur leiðréttrar meðalbreytingar frá upphafsgildi á fjölda RFBM á viku var 3,1 hjá hópnum sem fékk metýlnaltrexónbrómíð 12 mg einu sinni á dag, 2,1 hjá hópnum sem fékk metýlnaltrexónbrómíð
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS LABEL TEXT FOR TRAY LIDDING (PRE-FILLED SYRINGE PRESENTATION)
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM ÁLETRUN Á LOKI BAKKANS (ÁFYLLT SPRAUTA)
English: The Cmax and area under the plasma concentration-time curve (AUC) increase with dose increase from 0.15 mg/kg to 0.5 mg/kg in a dose proportional manner.
Icelandic: Hámarksþéttni Cmax og AUC gildi (svæðið undir blóðþéttni-tímaferlinum) hækka í réttu hlutfalli við skammta, þegar skammtar eru auknir úr 0,15 mg/kg í 0,5 mg/kg. Nýting 0,30 mg/kg skammts undir húð er 82 % af nýtingu 0,30 mg/kg skammts í bláæð.
English: Make sure the liquid in the pre-filled syringe is clear and colourless to pale yellow, and does not have any particles in it.
Icelandic: Gakktu úr skugga um að lausnin í forfylltu sprautunni sé tær og litlaus eða fölgul og án sýnilegra agna.
English: Sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH).
Icelandic: Natríumklóríð, natríumkalsíumedetat, glýsín hýdróklóríð, vatn fyrir stungulyf, saltsýra (til að stilla pH) og natríumhýdroxíð (til að stilla pH).
English: Relistor 12 mg/0.6 mL solution for injection Methylnaltrexone bromide
Icelandic: Relistor 12 mg/0,6 ml stungulyf, lausn Metýlnaltrexónbrómíð
English: Methylnaltrexone bromide-treated patients also had significantly higher rates of laxation within 4 hours after at least 2 of the first 4 doses (52 %) than did placebo-treated patients (9 %); p<0.0001.
Icelandic: eftir að minnsta kosti tvo af fyrstu fjórum skömmtunum (52 %) en hjá sjúklingunum sem fengu lyfleysu (9 %); p<0.0001.
English: Step 2: Preparing the injection syringe
Icelandic: Lyfjagjöfin undirbúin Skref 2:
English: Opioid-induced constipation in adult patients with advanced illness The efficacy and safety of methylnaltrexone bromide in the treatment of opioid-induced constipation in patients receiving palliative care was demonstrated in two randomised, double-blind, placebocontrolled studies.
Icelandic: Sýnt var fram á verkun og öryggi metýlnaltrexónbrómíðs við meðferð á hægðatregðu af völdum ópíóíða hjá sjúklingum á líknandi meðferð í tveimur slembuðum, tvíblindum samanburðarrannsóknum með lyfleysu.
English: 2 vials of 0.6 mL
Icelandic: 12 mg/0,6 ml
English: water for injections, hydrochloric acid (to adjust pH) and sodium hydroxide (to adjust pH).
Icelandic: Natríumkalsíumedetat Glýsín hýdróklóríð Vatn fyrir stungulyf Saltsýra (til að stilla pH) Natríumhýdroxíð (til að stilla pH)
English: Hepatic and renal impairment
Icelandic: Alvarleiki og versnun einkenna
English: After the needle is inserted, let go of the skin and slowly push the plunger all the way down until the pre-filled syringe is empty.
Icelandic: Eftir að þú hefur stungið nálinni í húðina, skaltu sleppa takinu á húðinni og þrýsta stimplinum rólega alla leið niður þar til forfyllta sprautan er tóm.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT (VIAL PRESENTATION)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI ASKJA (HETTUGLAS)
English: Important information about some of the ingredietns of Relistor This medicine contains less than 1 mmol sodium (23 mg) per dose i.e., essentially “sodium free.”
Icelandic: Relistor Lyfið inniheldur minna en 1 mmól af natríum (23 mg) í hverjum skammti þ.e. er í eðli sínu natríumsnautt.
English: You will be instructed by your doctor, nurse or pharmacist on the techniques of self-injection.
Icelandic: Læknirinn, hjúkrunarfræðingur eða lyfjafræðingur mun sýna þér hvernig þú getur gefið þér lyfið sjálf(ur).
English: 1 vial of 0.6 mL
Icelandic: 1 hettuglas með 0,6 ml
English: Rapid onset of bowel movements
Icelandic: Bómullarhnoðri eða grisja Plástur
English: Methylnaltrexone bromide-treated patients had a significantly higher rate of laxation within 4 hours of the double-blind dose (62 % for 0.15 mg/kg and 58 % for 0.3 mg/kg) than placebo-treated patients (14 %); p<0.0001 for each dose versus placebo.
Icelandic: eftir skammtinn sem gefinn var tvíblint (62 % fyrir 0,15 mg/kg og 58 % fyrir 0,3 mg/kg), en hjá sjúklingunum sem fengu lyfleysu (14 %); p<0,0001 fyrir báða skammtana í samanburði við lyfleysu.
English: Methylnaltrexone sulphate is an inactive metabolite and present in plasma at a level of approximately 25 % of drug related materials.
Icelandic: Metýlnaltrexónsúlfat er óvirkt niðurbrotsefni og svarar til 25 % af lyfinu og afleiðum þess.
English: There was no significant relationship between baseline opioid dose and laxation response in methylnaltrexone bromide-treated patients in these studies.
Icelandic: Í þessum rannsóknum voru engin marktæk tengsl á milli upphaflegs ópíóíðaskammts og hægðalosandi svörunar hjá þeim sjúklingum sem fengu metýlnaltrexónbrómíð.
English: Methylnaltrexone bromide
Icelandic: Munurinn á metýlnaltrexónbrómíði
English: - The other ingredients are sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH) and sodium hydroxide (to adjust pH).
Icelandic: - Önnur innihaldsefni eru natríumklóríð, natríumkalsíumedetat, glýsín hýdróklóríð, vatn fyrir stungulyf, saltsýra (til stillingar á sýrustigi) og natríum hýdroxíð (til stillingar á sýrustigi).
English: 2 vials with 2 sterile 1 mL injection syringes with retractable injection needle and 4 alcohol swabs; or 7 vials with 7 sterile 1 mL injection syringes with retractable injection needle and 14 alcohol swabs.
Icelandic: 2 hettuglösum með 2 sæfðum 1 ml sprautum til inndælingar með inndraganlegri nál og 4 sprittþurrkum; eða
English: There are no data available from patients with end-stage renal impairment on dialysis, and methylnaltrexone bromide is not recommended in these patients (see section 4.4).
Icelandic: Engar upplýsingar liggja fyrir um sjúklinga sem hafa nýrnasjúkdóm á lokastigi og eru á blóðskilun og ekki er mælt með notkun metýlnaletrexónbrómíðs hjá þessum sjúklingum (sjá kafla 4.4).
English: Methylnaltrexone bromide is absorbed rapidly, with peak concentrations (Cmax) achieved at approximately 0.5 hours following subcutaneous administration.
Icelandic: Metýlnaltrexónbrómíð frásogast hratt, hámarksþéttni (Cmax) næst u.þ.b. 0,5 klst. eftir gjöf undir húð.
English: It is clear, colourless to pale yellow, and does not contain flakes or particles.
Icelandic: Það er tært, litlaust eða fölgult og án sýnilegra agna.
English: Syringe Needle Retracts After Use
Icelandic: Sprautunálin dregst inn eftir notkun
English: Stool consistency was not meaningfully improved in patients who had soft stool at baseline.
Icelandic: Þéttleiki hægða batnaði ekki að marki hjá sjúklingum sem höfðu mjúkar hægðir fyrir meðferð.
English: Each syringe of 0.4 mL contains 8 mg methylnaltrexone bromide.
Icelandic: Hver sprauta með 0,4 ml inniheldur 8 mg af metýlnaltrexónbrómíði.
English: There were no clinically relevant changes in pain scores from baseline in either the methylnaltrexone bromide or placebo-treated patients.
Icelandic: Ekki voru klínískt mikilvægar breytingar frá upphafsgildi í stigun verkja, hvorki hjá sjúklingunum sem fengu metýlnaltrexónbrómíð né þeim sem fengu lyfleysu.
English: There was no evidence of a differential effect of gender on safety or efficacy.
Icelandic: Engin merki voru um mun á öryggi eða verkun milli kynja.
English: Methylnaltrexone bromide is not recommended in patients with severe hepatic impairment or with end-stage renal impairment requiring dialysis (see section 4.2).
Icelandic: Ekki er mælt með gjöf metýlnaltrexónbrómíðshanda sjúklingum sem hafa verulega skerðingu á lifrarstarfsemi né sjúklingum sem hafa nýrnasjúkdóm á lokastigi sem þarfnast blóðskilunar (sjá kafla 4.2).
English: An integrated analysis of pharmacokinetic data from healthy subjects indicated that methylnaltrexone bromide mg/kg dose-adjusted exposure increased as body weight increased.
Icelandic: Heildargreining á niðurstöðum lyfjahvarfarannsókna hjá heilbrigðum einstaklingum sýndi að útsetning fyrir metýlnaltrexónbrómíði, aðlöguð m.t.t. skammta, mg/kg, jókst með aukinni líkamsþyngd.
English: Not known: Gastrointestinal perforation (see section 4.4) Common: Vomiting
Icelandic: Rof í meltingarvegi (sjá kafla 4.4) Algengar:
English: INSTRUCTIONS ON USE
Icelandic: Sprautan undirbúin
English: Pick up the syringe from your work surface.
Icelandic: Taktu sprautuna upp af vinnuborðinu.
English: • Abdominal pain (belly ache)
Icelandic: YTRI UMBÚÐUM ASKJA (ÁFYLLT SPRAUTA)
English: The recommended dose for patients receiving supportive care for 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.
Icelandic: Ráðlagður skammtur fyrir sjúklinga sem fá stuðningsmeðferð við langt gengnum sjúkdómi er 8 mg af metýlnaltrexónbrómíði (0,4 ml af lausn) fyrir sjúklinga sem vega 38-61 kg eða 12 mg (0,6 ml af lausn) fyrir sjúklinga sem vega 62-114 kg.
English: Make sure the solution in the vial is clear and colourless to pale yellow, and does not contain flakes or particles.
Icelandic: Gakktu úr skugga um að lausnin í hettuglasinu sé tær og litlaus eða fölgul og án sýnilegra agna.
English: BATCH NUMBER Lot
Icelandic: Bausch & Lomb
English: A supplementary analysis evaluated the percentage of patients achieving ≥3 complete RFBMs per week and an increase of ≥1 complete
Icelandic: Viðbótargreining mat hlutfall sjúklinga með ≥ 3 heilar RFBM á viku og fjölgun um ≥ 1 heilar RFBM á viku síðustu 3 af 4
English: Common: opioid-withdrawal-like symptoms (like chills, tremor, rhinorrhea, piloerection, hot flush, palpitation, hyperhidrosis, vomiting, abdominal pain)
Icelandic: Einkenni lík ópíóíðfráhvarfi (hrollur, skjálfti, nefrennsli, hárris, hitasteypa, hjartsláttarónot, ofsviti, uppköst, kviðverkur)
English: Methylnaltrexone bromide is eliminated primarily as the unchanged active substance.
Icelandic: Brotthvarf metýlnaltrexónbrómíðs verður fyrst og fremst á formi óbreytts virks efnis.
English: Step 4b: Injecting Relistor using a standard injection syringe and injection needle
Icelandic: Relistor með því að nota venjulega sprautu og nál
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Icelandic: Ekki má blanda þessu lyfi saman við önnur lyf þar sem rannsóknir á samrýmanleika hafa ekki verið gerðar.
English: 4-week double-blind phase.
Icelandic: Pakkning sem inniheldur 2 hettuglös.
English: Hepatic impairment
Icelandic: Haltu hettuglasinu
English: complete RFBMs per week in at least 3 of the 4 treatment weeks.
Icelandic: Viðbótargreining mat hlutfall sjúklinga með ≥ 3 heilar RFBM á viku og fjölgun um ≥ 1 heilar RFBM á viku síðustu 3 af 4 meðferðarvikunum.
English: If you use more Relistor than you should
Icelandic: Ef stærri skammtur en mælt er fyrir um er notaður
English: Each syringe of 0.6 mL contains 12 mg methylnaltrexone bromide.
Icelandic: Hvert hettuglas með 0,6 ml inniheldur 12 mg af metýlnaltrexónbrómíði.
English: • Nausea (feeling sick)
Icelandic: Kviðverkir (magaverkir)
English: OTHER Keep the vial in the outer carton in order to protect from light.
Icelandic: ANNAÐ Geymið hettuglasið í ytri umbúðum til varnar gegn ljósi.
English: Methylnaltrexone bromide is metabolised to a modest extent in humans based on the amount of methylnaltrexone bromide metabolites recovered from excreta.
Icelandic: Metýlnaltrexónbrómíð er ekki mikið umbrotið hjá mönnum sé tekið mið af magni umbrotsefna sem finnst í metýlnaltrexónbrómíð úrgangsefnum líkamans.
English: - If you develop severe or persistent diarrhoea (passing of frequent watery stools), discontinue therapy and contact your doctor immediately.
Icelandic: ef þú færð alvarlegan eða langvarandi niðurgang verður þú að hætta meðferðinni og hafa tafarlaust samband við lækninn.
English: Step 3: Choosing and preparing an injection site 1.
Icelandic: Stungustaður valinn og undirbúinn Skref 4a:
English: The renal clearance of methylnaltrexone bromide decreased with increasing severity of renal impairment.
Icelandic: Úthreinsun metýlnaltrexónbrómíðs um nýru minnkaði með aukinni skerðingu á nýrnastarfsemi.
English: With the needle still inserted in the upside down vial, check for air bubbles in the syringe.
Icelandic: Haltu sprautunni þannig að nálin vísi beint upp og athugaðu aftur hvort loftbólur séu í sprautunni.
English: There were 2 primary endpoints: proportion of patients with a rescue-free laxation within 4 hours of the first dose of study medicinal product and proportion of patients with a rescue-free laxation within 4 hours after at least 2 of the first 4 doses of medicinal product.
Icelandic: Meginendapunktarnir voru tveir: hlutfall sjúklinga sem hafði hægðir án bráðahægðalyfs innan 4 klst.
English: Each pre-filled syringe contains 0.4 mL of solution for injection.
Icelandic: Hver áfyllt sprauta inniheldur 0,4 ml af stungulyfi, lausn.
English: Median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebo-treated patients.
Icelandic: Miðgildi daglegra skammta ópíóíða var hvorki marktækt frá upphafsgildi hjá sjúklingum sem fengu metýlnaltrexónbrómíð né þeim sem fengu lyfleysu.
English: STATEMENT OF ACTIVE SUBSTANCE Each pre-filled syringe of 0.4 mL contains 8 mg of methylnaltrexone bromide.
Icelandic: VIRK(T) EFNI Hver áfyllt sprauta með 0,4 ml inniheldur 8 mg af metýlnaltrexónbrómíði.
English: Renal impairment
Icelandic: Relistor sprautu
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/011
Icelandic: MARKAÐSLEYFISNÚMER EU/1/08/463/011
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
Icelandic: Relistor sprautað með sprautu með inndraganlegri nál Skref 4b:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS LABEL TEXT FOR INTERMEDIATE CARTON (VIAL PRESENTATION)
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM ÁLETRUN Á INNRI ÖSKJU (HETTUGLAS)
English: Gender No meaningful gender differences have been observed.
Icelandic: Kyn Enginn marktækur munur hefur komið fram milli kynja.
English: 0.6 mL (12 mg) More than 114 kg 0.15 mg/kg
Icelandic: 0,6 ml (12 mg)
English: The recommended dose for patients with long-term pain (except patients receiving supportive care for advanced illness) is 12 mg methylnalrexone bromide (0.6 mL of solution) given as an injection under the skin, as needed, but at least given 4-times a week and up to once a day (7 times a week).
Icelandic: Ráðlagður skammtur fyrir sjúklinga með langvinna verki (nema sjúklinga sem fá stuðningsmeðferð við langt gengnum sjúkdómi) er 12 mg af metýlnaltexónbrómíði (0,6 ml af lausn) með inndælingu undir húð eftir þörfum, en a.m.k.
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/010
Icelandic: MARKAÐSLEYFISNÚMER EU/1/08/463/010
English: INFORMATION IN BRAILLE RELISTOR 12 mg/0.6 mL
Icelandic: HEITI LYFS Relistor 12 mg/0,6 ml stungulyf, lausn
English: The primary endpoint was the proportion of patients with a rescue-free laxation within 4 hours of the double-blind dose of study medicinal product.
Icelandic: Meginendapunktur rannsóknarinnar var það hlutfall sjúklinga sem hafði hægðir án bráðahægðalyfs innan 4 klst.
English: Dizziness is a common side effect of this medicine.
Icelandic: Akstur og notkun véla Sundl er algeng aukaverkun lyfsins.
English: In the event of an overdose, signs and symptoms of orthostatic hypotension should be monitored and reported to a physician.
Icelandic: Ef ofskömmtun á sér stað, skal fylgjast með því hvort fram komi einkenni stöðutengds lágþrýstings og hafa samband við lækni komi slík einkenni fram.
English: Step 3: Choosing and preparing an injection site
Icelandic: Stungustaður valinn og undirbúinn
English: Methylnaltrexone bromide is minimally metabolised by CYP isozymes.
Icelandic: Metýlnaltrexónbrómíð umbrotnar að litlu leyti fyrir tilstilli CYP ísóensíma.
English: STATEMENT OF ACTIVE SUBSTANCE Each pre-filled syringe of 0.6 mL contains 12 mg of methylnaltrexone bromide.
Icelandic: VIRK(T) EFNI Hver áfyllt sprauta með 0,6 ml inniheldur 12 mg af metýlnaltrexónbrómíði.
English: Each pre-filled syringe contains 0.6 mL of solution for injection.
Icelandic: Hver áfyllt sprauta inniheldur 0,6 ml af stungulyfi, lausn.
English: NAME OF THE MEDICINAL PRODUCT Relistor 8 mg solution for injection in pre-filled syringe
Icelandic: HEITI LYFS Relistor 8 mg stungulyf, lausn, í áfylltri sprautu.
English: Release your thumb from the plunger to allow the protective sleeve to cover the needle.
Icelandic: Taktu þumalinn af stimplinum til að nálarhlífin fari yfir nálina.
English: NAME OF THE MEDICINAL PRODUCT Relistor 12 mg solution for injection in pre-filled syringe
Icelandic: HEITI LYFS Relistor 12 mg stungulyf, lausn, í áfylltri sprautu.
English: Opioid-induced constipation in adult patients with advanced illness (palliative care patients) The recommended dose of methylnaltrexone bromide is 8 mg (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).
Icelandic: Ráðlagður skammtur fyrir sjúklinga sem fá stuðningsmeðferð við langt gengnum sjúkdómi er 8 mg af metýlnaltrexónbrómíði (0,4 ml af lausn) fyrir sjúklinga sem vega 38-61 kg eða 12 mg (0,6 ml af lausn)
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.
Icelandic: Ráðlagður skammtur af metýlnaltrexónbrómíði er 8 mg (0,4 ml af lausn) (fyrir sjúklinga sem vega 38-61 kg) eða 12 mg (0,6 ml af lausn) (fyrir sjúklinga sem vega 62-114 kg).
English: Place used pre-filled syringe in a closable, puncture-resistant container.
Icelandic: Settu notaða áfylltu sprautuna í stunguþolið ílát sem hægt er að loka.
English: 0.6 mL of solution (12 mg methylnaltrexone bromide) Read the package leaflet before use.
Icelandic: 0,6 ml af lausn (12 mg metýlnaltrexónbrómíð)
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/009
Icelandic: MARKAÐSLEYFISNÚMER EU/1/08/463/009
English: Clear, Type I, flint glass, single-use vial, grey butyl rubber stopper, and aluminium overseal with flipoff-cap.
Icelandic: Glært einnota hettuglas, gler af gerð I, grár bútýlgúmmítappi, álinnsigli og lok sem smellt er af.
English: Step 3: Injecting Relistor pre-filled syringe
Icelandic: Inndæling með Relistor í áfylltri sprautu
English: • If you have Crohn´s disease or gastrointestinal ulcers
Icelandic: ef þú ert með svæðisgarnabólgu eða sár í meltingarvegi
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/007
Icelandic: MARKAÐSLEYFISNÚMER EU/1/08/463/007
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/002
Icelandic: MARKAÐSLEYFISNÚMER EU/1/08/463/002
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/005
Icelandic: MARKAÐSLEYFISNÚMER EU/1/08/463/005
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/006
Icelandic: MARKAÐSLEYFISNÚMER EU/1/08/463/006
English: Avoid areas with scars or stretch marks.
Icelandic: ör eða húðslit.
English: 0.4 mL of solution (8 mg methylnaltrexone bromide) Read the package leaflet before use.
Icelandic: 0,4 ml af lausn (8 mg metýlnaltrexónbrómíð)
English: Weight
Icelandic: Samantekt
English: Patients with hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section
Icelandic: Engin þörf er á aðlögun hjá sjúklingum með væga eða í meðallagi mikla skerðingu á lifrarstarfsemi (sjá kafla 5.2).
English: Gastrointestinal (GI) conditions and GI perforation Methylnaltrexone bromide should be used with caution in patients with known or suspected lesions of the GI tract.
Icelandic: Sýna ber aðgát við notkun metýlnaltrexónbrómíðs hjá sjúklingum ef vitað er eða grunur leikur á að þeir séu með skemmdir í meltingarvegi.
English: Look for the needle tip inside the vial.
Icelandic: Athugaðu að þú sjáir nálarendann inni í hettuglasinu.
English: Nervous system disorders
Icelandic: Lyf við hægðatregðu.