natgillin/translations-raw huggingface dataset:
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'). 
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').
Imidlertid blev korte torakolumbale ekstra ribben observeret ved doser uden maternal toksicitet. 
Meanwhile, the short thoracolumbar supernumerary ribs were observed at doses without maternal toxicity.
Der er begrænsede oplysninger om anvendelsen af lusutrombopag hos patienter, der tidligere har været eksponeret for lusutrombopag. 
There is limited information on the use of lusutrombopag in patients previously exposed to lusutrombopag.
Lusutrombopag er en oralt aktiv TPO-receptoragonist. 
Lusutrombopag is an orally active TPO receptor agonist.
Hvis du har en svær leversygdom, skal du fortælle det til lægen, før du tager Mulpleo. 
If you have severe liver disease, tell your doctor before taking Mulpleo.
Den anbefalede dosislusutrombopag er 3 mg lusutrombopag en gang dagligt i 7 dage. 
The recommended dose is 3 mg lusutrombopag once daily for 7 days.
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 %). 
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%).
Hypromellose Titandioxid Triethylcitrat Talcum 
Hypromellose Titanium dioxide Triethyl citrate Talc
Disse begrænsede data tydede på, at der ikke var et unormalt mønster for en stigning af trombocyttallet for denne delpopulation. 
This limited data suggested no abnormal pattern of platelet count rise in this subpopulation.
Mulpleo må ikke administreres til ammende kvinder, da det blev udskilt i modermælken hos dyr. 
Mulpleo should not be administered to breast-feeding women as it was excreted in mammary milk in animals.
Randomiseringen blev stratificeret ved hjælp af trombocyttallet ved screening/baseline og det primære invasive indgreb. 
Randomisation was stratified by platelet count at screening/baseline and primary invasive procedure.
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. 
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.
Personerne blev randomiseret til enten 3 mg lusutrombopag eller placebo i forholdet 1:1. 
Subjects were randomised to either of 3 mg of lusutrombopag or placebo in a 1:1 ratio.
LUSU = lusutrombopag, Q1 = 25. percentil, Q3 = 75. percentil [a] P-værdien blev beregnet ved hjælp af van Elteren-test med trombocyt-transfusionsstatus som stratum. 
LUSU = lusutrombopag; Q1 = 25th percentile; Q3 = 75th percentile [a] P-value was calculated by the van Elteren test with platelet transfusion status as stratum.
En overdosering kan inducere en kraftig stigning af trombocyttallet, og det kan efterfølgende fremkalde en medicinsk tilstand, der kan forårsage trombose eller tromboemboli. 
Overdose may induce an excessive increase of platelet counts, and it may subsequently provoke a medically susceptible state to cause thrombosis and thromboembolism.
Anvendelse til patienter med kronisk leversygdom, der gennemgår invasive indgreb 
Use in patients with chronic liver disease undergoing invasive procedures
I studie M0634 blev 3 personer med Child-Pugh klasse C leversygdom fejlagtigt inkluderet (alle i lusutrombopag-gruppen). 
In Study M0634, 3 subjects with Child-Pugh class C liver disease were erroneously enrolled (all in the lusutrombopag group).
Geometrisk gennemsnit (% variationskoefficient, CV) bortset fra Tmax, som er medianen (interval). 
Geometric mean (%CV) other than for Tmax, which is median (range).
• Blodprop i leveren (portvenetrombose) 
• Blood clot in the liver (portal vein thrombosis)
En person i lusutrombopaggruppen trak sig ud af studiet før administration af studielægemiddel. 
One subject in the lusutrombopag group withdrew from the study prior to administration of study drug.
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Shionogi 
NAME OF THE MARKETING AUTHORISATION HOLDER Shionogi
De farmakokinetiske parametre hos patienter med kronisk leversygdom vises i tabel 6. 
The pharmacokinetic parameters in patients with chronic liver disease are shown in Table 6.
Trombocyttal (*10^4/ul) 
Platelet Count (*10^4/uL)
Lægemiddelinteraktioner via inhibering og induktion af CYP4A-enzymer er ikke blevet rapporteret ved klinisk brug. 
Drug interactions via inhibition and induction of any CYP4A enzymes have not been reported in clinical use.
Foruden personer, som fik trombocyttransfusion, blev personer, som ikke fik et invasivt indgreb uanset årsag, anset for at have fået trombocyttransfusion. 
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.
Der bør udvises forsigtighed med hensyn til tromboemboliske hændelser efter invasive indgreb samt efter behandling uanset trombocyttal. 
Caution should be exercised with respect to thromboembolic events after invasive procedures as well as post-treatment regardless of platelet counts.
En person blev anset for ikke at have responderet, hvis personen først opfyldte kriteriet for respons efter en trombocyttransfusion. 
A subject was considered a nonresponder if the subject met the responder criterion only after platelet transfusion.
Du må ikke amme under behandlingen med Mulpleo, da det er ukendt, om lægemidlet udskilles i mælken. 
Do not breast-feed during treatment with Mulpleo, as it is not known if the medicine passes into milk.
Farmakoterapeutisk klassifikation: Hæmostatika, andre systemiske hæmostatika, ATC-kode: B02BX07 
Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics, ATC code: B02BX07
Farmakokinetik i delpopulationer 
Pharmacokinetics in subpopulations
In vitro-studier afdækkede, at CYP4-enzymer, herunder CYP4A11 og delvist CYP3A4-enzym, bidrog til ω-oxidation til frembringelse af 6-hydroxyleret lusutrombopag. 
In vitro studies revealed that CYP4 enzymes including CYP4A11 and partially CYP3A4 enzyme contributed to ω-oxidation to form 6-hydroxylated lusutrombopag.
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. 
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.
Tegn på en blodprop: vær opmærksom på følgende tegn: • hævelse, smerter, varme, rødme eller ømhed i benet 
Signs of a blood clot: look out for any of the signs below: • swelling, pain, heat, redness, or tenderness in your leg
Dosisjustering er ikke nødvendig hos patienter i alderen 65 år eller ældre (se pkt. 
No dosage adjustment is necessary in patients 65 years of age or older (see section 5.2).
Blandt de 48 personer i placebogruppen blev 46 behandlet i 7 dage, og 2 personer blev behandlet i 4 dage. 
Among the 48 subjects in the placebo group, 46 were treated for 7 days and 2 were treated for 4 days.
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. 
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.
CL/F (l/t) 
CL/F (L/hr)
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. 
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.
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. 
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.
I studie M0631 fik 96 personer lusutrombopag eller placebo en gang dagligt: 48 personer i lusutrombopaggruppen og 48 personer i placebogruppen. 
In Study M0631, 96 subjects received lusutrombopag or placebo once daily: 48 subjects in the lusutrombopag group and 48 subjects in the placebo group.
Lusutrombopag anses ikke for at påvirke farmakokinetikken for samtidigt administrerede lægemidler, der er substrater for disse enzymer eller transportere. 
Lusutrombopag is not considered to affect the pharmacokinetics of co-administered medicinal products that are substrates of these enzymes or transporters.
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. 
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.
Mulpleo leveres i aluminiumblisters i en æske indeholdende 7 filmovertrukne tabletter. 
Mulpleo is supplied in aluminium blisters in a carton containing 7 film-coated tablets.
Lusutrombopags virkning og sikker er ikke klarlagt, når det administreres før laparotomi, torakotomi, åben hjertekirurgi, kraniotomi eller organfjernelse. 
The efficacy and safety of lusutrombopag have not been established when administered before laparotomy, thoracotomy, open-heart surgery, craniotomy or excision of organs.
Blister af OPA/aluminiumsfolie/PVC-film med aluminiumsfolie, der kan trykkes igennem, pakket i en kartonæske. 
OPA/Aluminium foil/PVC film blister with push through aluminium lidding foil, packed in a cardboard box.
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). 
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).
Hver æske indeholder 7 filmovertrukne tabletter. 
Each box contains 7 film-coated tablets.
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. 
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.
Det primære sekundære endepunkt i studie M0631 og M0634 var 
The key secondary endpoints in Studies M0631 and M0634 were
I placebogruppen fik 94/107 personer (87,9 %) studielægemidlet i 7 dage. 
In the placebo group, 94/107 subjects (87.9%) received the study drug for 7 days.
I studie M0634 blev 215 personer randomiseret i studiet: 108 i gruppen med lusutrombopag 3 mg og 107 i placebogruppen. 
In Study M0634, 215 subjects were randomised in the study: 108 in the lusutrombopag 3 mg group and 107 in the placebo group.
Mulpleo indeholder det aktive stof lusutrombopag, som tilhører en gruppe af lægemidler, der kaldes trombopoietin-receptoragonister. 
Mulpleo contains the active substance lusutrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists.
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. 
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.
Hos rotter indikerede resultater, at lusutrombopag og dets metabolitter overføres til fosteret via placenta. 
In rats, results indicated that lusutrombopag and its metabolites transfer to fetus via placenta.
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. 
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.
En undertrykkelse af føtal intrauterin vækst samt cervikale ribben forekom ved doser (40 mg/kg/dag eller mere), der gav maternal toksicitet. 
A suppression of foetal intrauterine growth as well as cervical ribs occurred at doses (40 mg/kg/day or more), showing maternal toxicity.
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. 
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.
Behandlingsgruppe 
Treatment Group
Der må ikke tages en dobbeltdosis som erstatning for den glemte dosis. 
A double dose should not be taken to make up for a missed dose.
Studier med dyr har vist, at lusutrombopag udskilles i mælken hos diegivende rotter (se pkt. 
Studies in animals have shown lusutrombopag is secreted in the milk of lactating rats (see section 5.3).
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. 
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.
Det skal du vide, før du begynder at tage Mulpleo 
What you need to know before you take Mulpleo
Lusutrombopag har et lavt potentiale til at inhibere CYP-enzymer (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 og 3A4/5) og til at inducere både CYP-enzymer (CYP1A2, 2C9 og 3A4) og UGT-enzymer (UGT1A2, 1A6 og 2B7). 
Lusutrombopag has low potential to inhibit CYP enzymes (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4/5), and to induce both CYP enzymes (CYP1A2, 2C9, and 3A4) and UGT enzymes (UGT1A2, 1A6, and 2B7).
De mest almindelige bivirkninger var hovedpine (4,7 %, 8/171 patienter i lusutrombopag-gruppen, 3,5 %, 6/170 patienter i placebogruppen), kvalme (2,3 %, 4/171 patienter i lusutrombopag-gruppen, 4,1 %, 7/170 patienter i placebogruppen), portvenetrombose (1,2 %, 2/171 patienter i lusutrombopaggruppen, 1,2 %, 2/170 patienter i placebogruppen) og udslæt (1,2 %, 2/171 patienter i lusutrombopaggruppen, 0 %, 0/170 patienter i placebogruppen). 
The most common adverse reactions were headache (4.7%, 8/171 patients in the lusutrombopag group; 3.5%, 6/170 patients in the placebo group), nausea (2.3%, 4/171 patients in the lusutrombopag group; 4.1%, 7/170 patients in the placebo group), portal vein thrombosis (1.2%, 2/171 patients in the lusutrombopag group; 1.2%, 2/170 patients in the placebo group) and rash (1.2%, 2/171 patients in the lusutrombopag group; 0%, 0/170 patients in the placebo group).
Hvis du har taget for meget 
If you take more than you should
Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisterne efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the carton and blisters after EXP.
Blandt de 48 personer i lusutrombopaggruppen fik 40 personer lusutrombopag i 7 dage, 4 personer i 6 dage, 1 person i 5 dage og 3 personer i 4 dage. 
Among the 48 subjects in the lusutrombopag group, 40 subjects received lusutrombopag for 7 days, 4 subjects for 6 days, 1 subject for 5 days, and 3 subjects for 4 days.
Mikrokrystallinsk cellulose Magnesiumoxid Natriumlaurilsulfat Hydroxypropylcellulose Carmellosecalcium Magnesiumstearat 
Microcrystalline cellulose Magnesium oxide Sodium lauryl sulfate Hydroxypropylcellulose Carmellose calcium Magnesium stearate
Hvis du har taget for meget Mulpleo, skal du kontakte lægen eller tage på hospitalet. 
If you have taken more Mulpleo than you should, talk to your doctor or go to the hospital.
Lusutrombopag blev primært elimineret via fæces hos mennesker (ca. 83 % i fæces og 1 % i urin). 
Lusutrombopag was excreted mainly via faecal route in humans (approximately 83% into faeces and 1% into urine).
Derfor er det usandsynligt, at induktorer og inhibitorer af CYP4A-enzymer, herunder CYP4A11, vil påvirke lusutrombopags farmakokinetik. 
Therefore, inducers and inhibitors of CYP4A enzymes including CYP4A11 are unlikely to affect the pharmacokinetics of lusutrombopag.
➤ Du skal drøfte det med din læge, hvis dette gælder for dig, før du tager Mulpleo 
➤ Check with your doctor if this applies to you before you take Mulpleo
Interferonpræparater har vist sig at reducere trombocyttal, hvilket man bør tage i betragtning, når lusutrombopag administreres sammen med interferonpræparater. 
Interferon preparations have been known to reduce platelet counts, therefore, this should be considered when co-administering lusutrombopag with interferon preparations.
Lusutrombopags farmakokinetik var sammenlignelig hos både raske personer og populationen med kronisk leversygdom. 
The pharmacokinetics of lusutrombopag was similar in both healthy subjects and the chronic liver disease population.
- Øvrige indholdsstoffer: - Tabletkerne: mannitol, mikrokrystallinsk cellulose, magnesiumoxid, natriumlaurilsulfat, hydroxypropylcellulose, carmellosecalcium og magnesiumstearat - Filmovertræk: hypromellose, titandioxid, triethylcitrat, talcum og rød jernoxid (E172) 
- The other ingredients are: - Tablet core: mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropylcellulose, carmellose calcium and magnesium stearate - Film coating: hypromellose, titanium dioxide, triethyl citrate, talc and red-ferric oxide (E172)
I lusutrombopaggruppen fik 73/107 personer (68,2 %) studielægemidlet i 7 dage. 
In the lusutrombopag group, 73/107 subjects (68.2%) received the study drug for 7 days.
I fæces var komponenterne med radioaktivitet uændret lusutrombopag (16 % af administreret radioaktivitet) og β-oxidationsrelaterede metabolitter (35 % af administreret radioaktivitet), hvilket tyder på, at lusutrombopag først metaboliseres ved ω-oxidation og efterfølgende metaboliseres ved β-oxidation af O-hexyl-sidekæden. 
In faeces, the components of radioactivity were unchanged lusutrombopag (16% of administered radioactivity) and β-oxidation related metabolites (35% of administered radioactivity), suggesting that lusutrombopag is metabolised by ω-oxidation first, and subsequently metabolised by β-oxidation of O-hexyl side chain.
Tabel 6 Farmakokinetiske parametre for lusutrombopag efter 3 mg dosis en gang dagligt hos trombocytopeniske patienter med kronisk leversygdom (studie M0634) 
Table 6 Pharmacokinetic parameters of lusutrombopag after 3 mg dose once daily in thrombocytopenic patients with chronic liver disease (Study M0634)
I det kliniske lægemiddelinteraktionsstudie øgede samtidig administration af ciclosporin, en P-gp- og BCRP-dobbeltinhibitor Cmax- og AUCinf-værdier af lusutrombopag med ca. 20 % sammenlignet med lusutrombopag-administration alene. 
In the clinical drug-drug interaction study, co-administration of cyclosporine, a P-gp and BCRP dual inhibitor, increased the Cmax and AUCinf values of lusutrombopag by approximately 20% compared with lusutrombopag administration alone.
Let og moderat nedsat leverfunktion (let, Child-Pugh klasse A, moderat, Child-Pugh klasse B) forventes kun at have en lille virkning på lusutrombopags farmakokinetik. 
Mild and moderate hepatic impairment (mild, Child-Pugh class A; moderate, Child-Pugh class B) is expected to have little effect on the pharmacokinetics of lusutrombopag.
Hverken fødevarer (herunder kost med højt fedtindhold og mange kalorier) eller samtidig administration af calcium har en klinisk betydningsfuld virkning på lusutrombopags farmakokinetik. 
Neither food (including high-fat and high-calorie diet) nor co-administration with calcium has a clinically meaningful effect on the pharmacokinetics of lusutrombopag.
Patienter med kronisk leversygdom har en risiko for portvenetrombose og mesenterisk venetrombose. 
Patients with chronic liver disease have a risk of portal vein thrombosis and mesenteric vein thrombosis.
Tabel 4 Andel af personer med respons Studie M0631 
Table 4 Proportion of responders Study M0631
Graviditet og amning Tag ikke Mulpleo, hvis du er gravid, medmindre lægen specifikt anbefaler det. Mulpleos virkning under graviditeten er ukendt. 
Pregnancy and breast-feeding Do not take Mulpleo if you are pregnant unless your doctor specifically recommends it.
Lusutrombopag viste ingen teratogenicitet hos rotter og kaniner ved doser på op til hhv. 80 mg/kg/dag og 1000 mg/kg/dag. 
Lusutrombopag showed no teratogenicity in rats and rabbits at up to 80 mg/kg/day and 1000 mg/kg/day respectively.
Høj dosis (10 mg/kg/dag) af og langvarig behandling (8 uger) med lusutrombopag indebærer en mulig risiko for fibrose i knoglemarven via den humane TPO-receptor baseret på resultaterne af et studie med TPOR-Ki/Shi-mus med kimært humant transmembrandomæne TPO-receptor ved knock-in på muse-TPO-receptoren. 
High dose (10 mg/kg/day) and long-term treatment (8 weeks) of lusutrombopag has a potential risk of fibrosis in the bone marrow via human TPO receptor based on the results of study in TPOR-Ki/Shi mice with chimeric human transmembrane domain TPO receptor knocked-in to the mouse TPO receptor.
Indehaver af markedsføringstilladelsen Shionogi B.V. 
Marketing Authorisation Holder Shionogi B.V.