FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration with interferon preparations
Danish: Administration sammen med interferonpræparater
English: Take the tablet with a liquid and swallow it whole.
Danish: Tag tabletten sammen med væske, og slug den hel.
English: Environmental risk assessment studies have shown that lusutrombopag has the potential to be very persistent, very bioaccumulative and toxic to the environment.
Danish: Miljørisikovurderingsstudier har vist, at lusutrombopag har potentialet til at være meget bestandigt, meget bioakkumulativt og toksisk for miljøet.
English: Kingsfordweg 151, 1043GR Amsterdam The Netherlands
Danish: Kingsfordweg 151, 1043GR Amsterdam Holland
English: DATE OF REVISION OF THE TEXT
Danish: 10, DATO FOR ÆNDRING AF TEKSTEN
English: The safety and efficacy of lusutrombopag in children and adolescents (< 18 years of age) have not been established.
Danish: Lusutrombopags sikkerhed og virkning hos børn og unge (< 18 år) er ikke klarlagt.
English: Lusutrombopag is absorbed with a peak concentration occurring 6 to 8 hours after oral administration.
Danish: Lusutrombopag bliver absorberet med en maksimal koncentration 6 til 8 timer efter oral administration.
English: The procedure should be performed from day 9 after the start of lusutrombopag treatment.
Danish: Indgrebet skal udføres fra dag 9 efter start på lusutrombopag-behandlingen.
English: Platelet counts should be measured frequently and the condition of patients should be observed closely.
Danish: Trombocyttallet skal måles hyppigt, og patientens tilstand skal observeres nøje.
English: There is no specific antidote for lusutrombopag overdose.
Danish: Der er ingen specifik antidot mod en overdosering af lusutrombopag.
English: Do not chew, break, or crush the tablet.
Danish: Du må ikke tygge, dele eller knuse tabletten.
English: - Use reliable methods of contraception while you are taking Mulpleo.
Danish: - Anvend sikre præventionsmetoder, mens du tager Mulpleo.
English: Do not take Mulpleo: - if you are allergic to lusutrombopag or any of the other ingredients of this medicine (listed in section 6 under ‘What Mulpleo contains').
Danish: Tag ikke Mulpleo: - hvis du er allergisk over for lusutrombopag eller et af de øvrige indholdsstoffer i Mulpleo (angivet i punkt 6 under ‘Mulpleo indeholder').
English: INFORMATION IN BRAILLE Mulpleo
Danish: INFORMATION I BRAILLESKRIFT Mulpleo
English: Paediatric population No pharmacokinetic data have been obtained in children.
Danish: Pædiatrisk population Der er ikke blevet indsamlet farmakokinetiske data hos børn.
English: All 3 received 7 days of treatment with lusutrombopag.
Danish: Alle 3 fik 7 dages behandling med lusutrombopag.
English: Red ferric oxide (E172)
Danish: Rød jernoxid (E172)
English: Do not stop taking Mulpleo without talking to your doctor and do not take Mulpleo for more than 7 days.
Danish: Du må ikke holde op med at tage Mulpleo uden at kontakte lægen, og du må ikke tage Mulpleo i mere end 7 dage.
English: Therefore, a potential interaction with either P-gp or BCRP inhibitors cannot be excluded, but no dose adjustment is necessary at the recommended clinical dosage of 3 mg in adults.
Danish: Derfor kan en mulig interaktion med enten P-gp- eller BCRP-inhibitorer ikke udelukkes, men en dosisjustering er ikke nødvendig ved den anbefalede kliniske dosering på 3 mg hos voksne.
English: [b] Cochran-Mantel-Haenszel test with baseline platelet count as stratum.
Danish: [b] Cochran-Mantel-Haenszel-test med trombocyttal ved baseline som stratum.
English: Table 1 Adverse reactions System Organ Class
Danish: Tabel 1 Bivirkninger Systemorganklasse
English: - If you do become pregnant during treatment with Mulpleo, tell your doctor immediately.
Danish: - Hvis du bliver gravid i løbet af behandlingen med Mulpleo, skal du straks fortælle det til lægen.
English: Repeated toxicity
Danish: Gentagen toksicitet
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Mulpleo is used to reduce the risk of bleeding during surgery and other procedures (including tooth extractions and endoscopy).
Danish: Mulpleo anvendes til at reducere risikoen for blødning under en operation og ved andre indgreb (herunder tandudtrækninger og endoskopi).
English: There are no or limited amount of data from the use of lusutrombopag in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af lusutrombopag til gravide kvinder.
English: Since the protein-binding rate in serum of lusutrombopag is high, haemodialysis is not thought to be effective.
Danish: Da proteinbindingshastigheden i serum for lusutrombopag er høj, menes hæmodialyse ikke at være effektiv.
English: Warnings and precautions Talk to your doctor: - if you are at risk of blood clots in your veins or arteries, or if you previously have had blood clots - if you have severe liver disease - if your spleen has been removed - if you are having interferon treatment.
Danish: Advarsler og forsigtighedsregler Kontakt lægen: - hvis du har risiko for blodpropper i vener eller arterier, eller hvis du tidligere har haft blodpropper - hvis du har en svær leversygdom - hvis du har fået fjernet milten - hvis du får behandling med interferon.
English: Adverse reaction - Common
Danish: Bivirkning - Almindelig
English: P-gp and BCRP inhibitors
Danish: P-gp- og BCRP-inhibitorer
English: It is given to adults who have low numbers of platelets because of chronic liver disease.
Danish: Det gives til voksne, der har et lavt antal blodplader som følge af kronisk leversygdom.
English: On Day 5 to Day 7, the platelet count was measured before administration of study drug.
Danish: På dag 5 til dag 7 blev trombocyttallet målt før administration af studielægemidlet.
English: It is unknown whether lusutrombopag or its metabolites are excreted in human milk.
Danish: Det er ukendt, om lusutrombopag eller dets metabolitter udskilles i human mælk.
English: Lusutrombopag is rarely excreted into urine (approximately 1%).
Danish: Lusutrombopag udskilles sjældent i urinen (ca. 1 %).
English: Do not change the dose or schedule for taking Mulpleo unless your doctor or pharmacist tells you to.
Danish: Du må ikke ændre dosis af eller tidsplanen for indtagelsen af Mulpleo, medmindre lægen eller apotekspersonalet fortæller dig det.
English: These patients should be clinically monitored when treated with lusutrombopag.
Danish: Disse patienter skal overvåges klinisk, når de behandles med lusutrombopag.
English: • sudden shortness of breath, especially with sharp pain in the chest or rapid breathing
Danish: • pludselig stakåndethed, især med en borende smerte i brystet eller hurtig vejrtrækning
English: Thus, the data from the toxicology program in these animals do not present potential adverse effects related to exaggerated pharmacology in humans.
Danish: Derfor fremviser data fra det toksikologiske program hos disse dyr ikke mulige bivirkninger relateret til den overdrevne farmakologi hos mennesker.
English: Geometric mean of t1/2 (% coefficient of variation), was 38.3 hours (18.7%) after multiple oral dose of 3 mg lusutrombopag.
Danish: Det geometriske gennemsnit af t1/2 (% variationskoefficient) var 38,3 timer (18,7 %) efter flere orale doser af 3 mg lusutrombopag.
English: You may be monitored for side effects associated with excessive platelets such as blood clots (see section 2, ‘Warnings and precautions', and section 4, ‘Possible side effects').
Danish: Du kan blive overvåget for bivirkninger, der er forbundet med et kraftigt forøget blodpladeantal, såsom blodpropper (se punkt 2, ‘Advarsler og forsigtighedsregler' og punkt 4, 'Bivirkninger').
English: Meanwhile, the short thoracolumbar supernumerary ribs were observed at doses without maternal toxicity.
Danish: Imidlertid blev korte torakolumbale ekstra ribben observeret ved doser uden maternal toksicitet.
English: There is limited information on the use of lusutrombopag in patients previously exposed to lusutrombopag.
Danish: Der er begrænsede oplysninger om anvendelsen af lusutrombopag hos patienter, der tidligere har været eksponeret for lusutrombopag.
English: Lusutrombopag is an orally active TPO receptor agonist.
Danish: Lusutrombopag er en oralt aktiv TPO-receptoragonist.
English: If you have severe liver disease, tell your doctor before taking Mulpleo.
Danish: Hvis du har en svær leversygdom, skal du fortælle det til lægen, før du tager Mulpleo.
English: The recommended dose is 3 mg lusutrombopag once daily for 7 days.
Danish: Den anbefalede dosislusutrombopag er 3 mg lusutrombopag en gang dagligt i 7 dage.
English: The mean (% coefficient of variation) apparent volume of distribution during the terminal phase of lusutrombopag in healthy adult subjects (n = 16) was 39.5 L (23.5%).
Danish: Det gennemsnitlige (% variationskoefficient) tilsyneladende fordelingsvolumen i løbet af den terminale fase af lusutrombopag hos raske voksne personer (n = 16) var 39,5 l (23,5 %).
English: Hypromellose Titanium dioxide Triethyl citrate Talc
Danish: Hypromellose Titandioxid Triethylcitrat Talcum
English: This limited data suggested no abnormal pattern of platelet count rise in this subpopulation.
Danish: Disse begrænsede data tydede på, at der ikke var et unormalt mønster for en stigning af trombocyttallet for denne delpopulation.
English: Mulpleo should not be administered to breast-feeding women as it was excreted in mammary milk in animals.
Danish: Mulpleo må ikke administreres til ammende kvinder, da det blev udskilt i modermælken hos dyr.
English: Randomisation was stratified by platelet count at screening/baseline and primary invasive procedure.
Danish: Randomiseringen blev stratificeret ved hjælp af trombocyttallet ved screening/baseline og det primære invasive indgreb.
English: There is limited information on the use of lusutrombopag in patients with body weight <45 Kg. Platelet count should be measured at least once approximately 5 days after the first dose and as necessary thereafter.
Danish: Der er begrænsede oplysninger om anvendelsen af lusutrombopag hos patienter med en legemsvægt <45 kg. Trombocyttallet skal måles mindst én gang ca. 5 dage efter den første dosis og derefter efter behov.
English: Subjects were randomised to either of 3 mg of lusutrombopag or placebo in a 1:1 ratio.
Danish: Personerne blev randomiseret til enten 3 mg lusutrombopag eller placebo i forholdet 1:1.
English: LUSU = lusutrombopag; Q1 = 25th percentile; Q3 = 75th percentile [a] P-value was calculated by the van Elteren test with platelet transfusion status as stratum.
Danish: LUSU = lusutrombopag, Q1 = 25. percentil, Q3 = 75. percentil [a] P-værdien blev beregnet ved hjælp af van Elteren-test med trombocyt-transfusionsstatus som stratum.
English: Overdose may induce an excessive increase of platelet counts, and it may subsequently provoke a medically susceptible state to cause thrombosis and thromboembolism.
Danish: En overdosering kan inducere en kraftig stigning af trombocyttallet, og det kan efterfølgende fremkalde en medicinsk tilstand, der kan forårsage trombose eller tromboemboli.
English: Use in patients with chronic liver disease undergoing invasive procedures
Danish: Anvendelse til patienter med kronisk leversygdom, der gennemgår invasive indgreb
English: In Study M0634, 3 subjects with Child-Pugh class C liver disease were erroneously enrolled (all in the lusutrombopag group).
Danish: I studie M0634 blev 3 personer med Child-Pugh klasse C leversygdom fejlagtigt inkluderet (alle i lusutrombopag-gruppen).
English: Geometric mean (%CV) other than for Tmax, which is median (range).
Danish: Geometrisk gennemsnit (% variationskoefficient, CV) bortset fra Tmax, som er medianen (interval).
English: • Blood clot in the liver (portal vein thrombosis)
Danish: • Blodprop i leveren (portvenetrombose)
English: One subject in the lusutrombopag group withdrew from the study prior to administration of study drug.
Danish: En person i lusutrombopaggruppen trak sig ud af studiet før administration af studielægemiddel.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Shionogi
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Shionogi
English: The pharmacokinetic parameters in patients with chronic liver disease are shown in Table 6.
Danish: De farmakokinetiske parametre hos patienter med kronisk leversygdom vises i tabel 6.
English: Platelet Count (*10^4/uL)
Danish: Trombocyttal (*10^4/ul)
English: Drug interactions via inhibition and induction of any CYP4A enzymes have not been reported in clinical use.
Danish: Lægemiddelinteraktioner via inhibering og induktion af CYP4A-enzymer er ikke blevet rapporteret ved klinisk brug.
English: In addition to subjects who received platelet transfusion, subjects who did not receive an invasive procedure regardless of the reason were considered as receiving platelet transfusion.
Danish: Foruden personer, som fik trombocyttransfusion, blev personer, som ikke fik et invasivt indgreb uanset årsag, anset for at have fået trombocyttransfusion.
English: Caution should be exercised with respect to thromboembolic events after invasive procedures as well as post-treatment regardless of platelet counts.
Danish: Der bør udvises forsigtighed med hensyn til tromboemboliske hændelser efter invasive indgreb samt efter behandling uanset trombocyttal.
English: A subject was considered a nonresponder if the subject met the responder criterion only after platelet transfusion.
Danish: En person blev anset for ikke at have responderet, hvis personen først opfyldte kriteriet for respons efter en trombocyttransfusion.
English: Do not breast-feed during treatment with Mulpleo, as it is not known if the medicine passes into milk.
Danish: Du må ikke amme under behandlingen med Mulpleo, da det er ukendt, om lægemidlet udskilles i mælken.
English: Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics, ATC code: B02BX07
Danish: Farmakoterapeutisk klassifikation: Hæmostatika, andre systemiske hæmostatika, ATC-kode: B02BX07
English: Pharmacokinetics in subpopulations
Danish: Farmakokinetik i delpopulationer
English: In vitro studies revealed that CYP4 enzymes including CYP4A11 and partially CYP3A4 enzyme contributed to ω-oxidation to form 6-hydroxylated lusutrombopag.
Danish: In vitro-studier afdækkede, at CYP4-enzymer, herunder CYP4A11 og delvist CYP3A4-enzym, bidrog til ω-oxidation til frembringelse af 6-hydroxyleret lusutrombopag.
English: The accumulation ratios of the Cmax and the AUC are approximately 2 at once-daily multiple doses and the steady-state of the plasma concentration of lusutrombopag appear to be achieved after Day 5.
Danish: Akkumulationsforholdet mellem Cmax og AUC er ca. 2 ved flere doser en gang dagligt, og steady-state for plasmakoncentrationen af lusutrombopag synes at blive nået efter dag 5.
English: Signs of a blood clot: look out for any of the signs below: • swelling, pain, heat, redness, or tenderness in your leg
Danish: Tegn på en blodprop: vær opmærksom på følgende tegn: • hævelse, smerter, varme, rødme eller ømhed i benet
English: No dosage adjustment is necessary in patients 65 years of age or older (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter i alderen 65 år eller ældre (se pkt.
English: Among the 48 subjects in the placebo group, 46 were treated for 7 days and 2 were treated for 4 days.
Danish: Blandt de 48 personer i placebogruppen blev 46 behandlet i 7 dage, og 2 personer blev behandlet i 4 dage.
English: Due to the unstable nature of these patients, they should be supported in line with clinical practice by close monitoring for early signs of worsening or new onset hepatic encephalopathy, ascites, and thrombotic or bleeding tendency, through monitoring of liver function tests, tests used for assessing clotting status and through imaging of portal vasculature as needed.
Danish: Grundet disse patienters ustabile natur skal de støttes i henhold til klinisk praksis ved nøje at overvåge for tidlige tegn på forværring af eller nyopdukket hepatisk encefalopati, ascites og trombose- eller blødningstendens via leverfunktionskontroller, tests, der anvendes til at vurdere størkningsstatus, og via billeddannelse af den portale vaskulatur efter behov.
English: CL/F (L/hr)
Danish: CL/F (l/t)
English: In addition, although no dose adjustment is required in these subjects, platelet count should be measured at least once approximately 5 days after the first dose and as necessary thereafter.
Danish: Selvom en dosisjustering ikke er nødvendig for disse personer, skal trombocyttallet måles mindst én gang ca. 5 dage efter den første dosis og derefter efter behov.
English: The ranges of observed Cmax and AUC0-τ overlapped among the patients with Child-Pugh class A, B, and C. Cmax and AUC0-τ of all patients with Child-Pugh class C did not exceed the maximum values from Child-Pugh class A and class B. Due to the limited information available, lusutrombopag should not be used in Child-Pugh class C patients unless the expected benefit outweighs the expected risks.
Danish: Intervallerne af observeret Cmax og AUC0-τ overlappede blandt patienter med Child-Pugh klasse A, B og C. Cmax og AUC0-τ for alle patienter med Child-Pugh klasse C overskred ikke maksimumværdierne fra Child-Pugh klasse A og klasse B. På grund af den tilgængelige begrænsede information bør lusutrombopag ikke anvendes hos Child-Pugh klasse C-patienter, medmindre den forventede fordel opvejer den forventede risiko.
English: In Study M0631, 96 subjects received lusutrombopag or placebo once daily: 48 subjects in the lusutrombopag group and 48 subjects in the placebo group.
Danish: I studie M0631 fik 96 personer lusutrombopag eller placebo en gang dagligt: 48 personer i lusutrombopaggruppen og 48 personer i placebogruppen.
English: Lusutrombopag is not considered to affect the pharmacokinetics of co-administered medicinal products that are substrates of these enzymes or transporters.
Danish: Lusutrombopag anses ikke for at påvirke farmakokinetikken for samtidigt administrerede lægemidler, der er substrater for disse enzymer eller transportere.
English: Eight lusutrombopag-treated subjects and 2 placebo-treated subjects received less than 7 days of treatment as they met the criterion for a responder prior to Day 7.
Danish: 8 personer behandlet med lusutrombopag og 2 personer behandlet med placebo fik under 7 dages behandling, da de opfyldte kriteriet for respons før dag 7.
English: Mulpleo is supplied in aluminium blisters in a carton containing 7 film-coated tablets.
Danish: Mulpleo leveres i aluminiumblisters i en æske indeholdende 7 filmovertrukne tabletter.
English: The efficacy and safety of lusutrombopag have not been established when administered before laparotomy, thoracotomy, open-heart surgery, craniotomy or excision of organs.
Danish: Lusutrombopags virkning og sikker er ikke klarlagt, når det administreres før laparotomi, torakotomi, åben hjertekirurgi, kraniotomi eller organfjernelse.
English: OPA/Aluminium foil/PVC film blister with push through aluminium lidding foil, packed in a cardboard box.
Danish: Blister af OPA/aluminiumsfolie/PVC-film med aluminiumsfolie, der kan trykkes igennem, pakket i en kartonæske.
English: The principal toxicity findings associated with lusutrombopag administration included prolongation of PT and APTT (rats), increased activities of plasma ALT and AST (rats and dogs), adrenal toxicity (rats and dogs), skin and forestomach lesions (rats) and renal toxicity (rats).
Danish: De primære toksicitetsfund forbundet med lusutrombopag-administration omfattede forlængelse af PT og APTT (rotter), forhøjet aktivitet af ALAT og ASAT i plasma (rotter og hunde), adrenal toksicitet (rotter og hunde), hud og formavelæsioner (rotter) og nyretoksicitet (rotter).
English: Each box contains 7 film-coated tablets.
Danish: Hver æske indeholder 7 filmovertrukne tabletter.
English: Lusutrombopag was not genotoxic when tested in a bacterial reverse mutation test, a chromosomal aberration test with cultured Chinese hamster lung cells, or an in vivo micronucleus test with mouse bone marrow cells.
Danish: Lusutrombopag var ikke genotoksisk ved test i en bakteriel revers mutationstest, en kromosomafvigelsestest med en kultur af lungeceller fra kinesiske hamstre eller en in vivomikronukleustest med knoglemarvsceller fra mus.
English: The key secondary endpoints in Studies M0631 and M0634 were
Danish: Det primære sekundære endepunkt i studie M0631 og M0634 var
English: In the placebo group, 94/107 subjects (87.9%) received the study drug for 7 days.
Danish: I placebogruppen fik 94/107 personer (87,9 %) studielægemidlet i 7 dage.
English: In Study M0634, 215 subjects were randomised in the study: 108 in the lusutrombopag 3 mg group and 107 in the placebo group.
Danish: I studie M0634 blev 215 personer randomiseret i studiet: 108 i gruppen med lusutrombopag 3 mg og 107 i placebogruppen.
English: Mulpleo contains the active substance lusutrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists.
Danish: Mulpleo indeholder det aktive stof lusutrombopag, som tilhører en gruppe af lægemidler, der kaldes trombopoietin-receptoragonister.
English: In order to allow an overall comparison of the results across Studies M0631 and M0634, as presented in Table 2 to Table 5, data from study M0631 was reanalysed according to the primary endpoint for study M0634.
Danish: For at tillade en overordnet sammenligning af resultaterne i studie M0631 og M0634 som vist i tabel 2 til tabel 5 blev data fra studie M0631 analyseret igen i henhold til det primære endepunkt for studie M0634.
English: In rats, results indicated that lusutrombopag and its metabolites transfer to fetus via placenta.
Danish: Hos rotter indikerede resultater, at lusutrombopag og dets metabolitter overføres til fosteret via placenta.
English: Lusutrombopag should be used when risk for bleeding is considered to be high according to clinical laboratory test values such as platelet counts and of the coagulation-fibrinolysis system, clinical symptoms and type of invasive procedure.
Danish: Lusutrombopag skal anvendes, når risikoen for blødning anses for at være høj i henhold til kliniske laboratorieresultater, såsom trombocyttal og resultater for koagulations-fibrinolysesystemet, kliniske symptomer og typen af det invasive indgreb.
English: A suppression of foetal intrauterine growth as well as cervical ribs occurred at doses (40 mg/kg/day or more), showing maternal toxicity.
Danish: En undertrykkelse af føtal intrauterin vækst samt cervikale ribben forekom ved doser (40 mg/kg/dag eller mere), der gav maternal toksicitet.
English: Both Cmax and AUC for lusutrombopag increase dose-proportionally over dose range of multiple oral dose of 0.25 to 4 mg once daily in patients with chronic liver disease.
Danish: Både Cmax og AUC for lusutrombopag øges dosisproportionalt over et dosisinterval med flere orale doser på 0,25 til 4 mg en gang dagligt hos patienter med kronisk leversygdom.
English: Treatment Group
Danish: Behandlingsgruppe
English: A double dose should not be taken to make up for a missed dose.
Danish: Der må ikke tages en dobbeltdosis som erstatning for den glemte dosis.
English: Studies in animals have shown lusutrombopag is secreted in the milk of lactating rats (see section 5.3).
Danish: Studier med dyr har vist, at lusutrombopag udskilles i mælken hos diegivende rotter (se pkt.
English: In patients with thrombosis or thromboembolism, with a history of thrombosis or thromboembolism, with absence of hepatopetal blood flow in the main trunk of the portal vein, or patients with congenital coagulopathy the risk for thrombosis or thromboembolism may increase.
Danish: Hos patienter med trombose eller tromboemboli, med trombose eller tromboemboli i anamnesen, med manglende hepatopetal blodgennemstrømning i hovedgrenen af portvenen eller med medfødt koagulopati kan risikoen for trombose eller tromboemboli øges.
English: What you need to know before you take Mulpleo
Danish: Det skal du vide, før du begynder at tage Mulpleo