FrancophonIA/ELRC3.0 huggingface dataset:
English: A population pharmacokinetic analysis using plasma lusutrombopag concentrations from clinical studies with lusutrombopag did not identify a clinically meaningful effect of renal function on the pharmacokinetics of lusutrombopag.
Danish: En populationsfarmakokinetisk analyse af plasmakoncentrationer af lusutrombopag fra kliniske studier med lusutrombopag identificerede ikke en klinisk betydningsfuld virkning af nyrefunktionen på lusutrombopags farmakokinetik.
English: AUC0-τ (ng·hr/mL)
Danish: AUC0-τ (ng·t/ml)
English: The changes were also noted in F1 pups on postnatal day (PND) 4 at 12.5 mg/kg/day or more in the preand postnatal development study; however, F1 mature animals showed no full and short thoracolumbar supernumerary rib.
Danish: Ændringerne blev også bemærket hos F1-afkom på postnatal dag (PND) 4 med 12,5 mg/kg/dag eller mere i det præ- og postnatale udviklingsstudie.
English: There is limited information on the use of lusutrombopag in patients with severe (Child-Pugh class C) hepatic impairment (see section 5.1).
Danish: Der foreligger begrænset information om anvendelsen af lusutrombopag til patienter med svært (Child-Pugh klasse C) nedsat leverfunktion (se pkt.
English: Each film-coated tablet contains 3 mg lusutrombopag.
Danish: Hver filmovertrukket tablet indeholder 3 mg lusutrombopag.
English: Lusutrombopag has also low potential to inhibit P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1, MATE2-K, and BSEP.
Danish: Lusutrombopag har også et lavt potentiale til at inhibere P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1, MATE2-K og BSEP.
English: Lusutrombopag therapy should only be initiated in patients with severe hepatic impairment if the expected benefit outweighs the expected risks (see sections 4.4 and 5.2).
Danish: Behandling med lusutrombopag må kun påbegyndes hos patienter med svært nedsat leverfunktion, hvis de forventede fordele opvejer de forventede risici (se pkt.
English: Mulpleo should be used with contraception (see sub-section Pregnancy and section 5.3).
Danish: Mulpleo skal anvendes sammen med kontraception (se underpkt.
English: Duration of the increase in platelet count to ≥ 50,000/μL
Danish: Varighed af stigning i trombocyttal til ≥ 50.000/μl
English: Due to limited information available, the safety and efficacy of Mulpleo in patients with severe hepatic impairment (Child-Pugh class C) have not been established (see sections 4.4 and 5.1).
Danish: På grund af begrænset tilgængelig information er Mulpleos sikkerhed og virkning ikke klarlagt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) (se pkt.
English: Food interaction
Danish: Fødevarepåvirkning
English: Table 3 Proportion of Subjects who required no platelet transfusion during the study (Day 1 through Day 35)
Danish: Tabel 3 Andel af personer, som ikke havde behov for trombocyttransfusion i løbet af studiet (dag 1 til og med dag 35)
English: Mulpleo 3 mg film-coated tablets lusutrombopag
Danish: Mulpleo 3 mg filmovertrukne tabletter lusutrombopag
English: There were no effects on pregnancy, parturition, lactation in F0 dams and postnatal development in F1 pups at doses up to 12.5 mg/kg/day (89 times the human clinical exposures in adults based on AUC).
Danish: Der var ingen virkninger på drægtighed, fødsel, diegivning hos F0-moderdyr og postnatal udvikling hos F1-afkom ved doser på op til 12,5 mg/kg/dag (89 gange den kliniske eksponering hos voksne mennesker baseret på AUC).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 3 mg of lusutrombopag.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 3 mg lusutrombopag.
English: The efficacy and safety of lusutrombopag have not been established when administered in patients with a history of splenectomy.
Danish: Anvendelse til patienter med splenektomi i anamnesen Lusutrombopags virkning og sikkerhed er ikke klarlagt, når det administreres til patienter med splenektomi i anamnesen.
English: No dosage adjustment is necessary in patients with renal impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: The duration of the increase in platelet count to ≥ 50,000/µL in Studies M0631 and M0634 and the pooled (Studies M0631 and M0634) lusutrombopag group was significantly greater than compared with placebo (Table 5).
Danish: Varigheden af stigningen i trombocyttallet til ≥ 50.000/µl i studie M0631 og M0634 og den puljede (studie M0631 og M0634) lusutrombopaggruppe var signifikant større sammenlignet med placebo (tabel 5).
English: Platelet count should be carefully monitored in patients with a history of splenectomy treated with lusutrombopag.
Danish: Trombocyttallet skal nøje overvåges hos patienter med splenektomi i anamnesen, som bliver behandlet med lusutrombopag.
English: Study M0631
Danish: Studie M0631
English: The Netherlands
Danish: HOLLAND
English: Study M0634
Danish: Studie M0634
English: No effects on foetal viability embryo-foetal development were noted in rabbits at doses up to 1000 mg/kg/day (161 times the human clinical exposures in adults based on AUC).
Danish: Der blev ikke bemærket nogen virkning på føtal levedygtighed eller embryoføtal udvikling hos kaniner ved doser på op til 1000 mg/kg/dag (161 gange den kliniske eksponering hos voksne mennesker baseret på AUC).
English: Lusutrombopag is a substrate of P-gp and BCRP, but is not a substrate of OATP1B1, OATP1B3 or OCT1.
Danish: Lusutrombopag er et substrat for P-gp og BCRP, men ikke et substrat for OATP1B1, OATP1B3 eller OCT1.
English: Lusutrombopag is a substrate of P-gp and BCRP, but not a substrate of OATP1B1, OATP1B3, and OCT1.
Danish: Lusutrombopag er et substrat for P-gp og BCRP, men ikke et substrat for OATP1B1, OATP1B3 og OCT1.
English: Figure 1 Time course profiles of platelet count in the Phase 3 studies in thrombocytopenic patients with chronic liver disease (lusutrombopag-treated subjects without platelet transfusion and placebo-treated subjects with platelet transfusion) Phase 3 Study M0631
Danish: Figur 1 Tidsforløbprofiler af trombocyttal i fase III-studier hos trombocytopeniske patienter med kronisk leversygdom (personer behandlet med lusutrombopag uden trombocyttransfusion og placebobehandlede personer med trombocyttransfusion)
English: Lusutrombopag did not affect male or female fertility in rats at doses up to 176 and 252 times the human clinical exposures in adults based on AUC in males and females, respectively (see section 5.3).
Danish: Lusutrombopag påvirkede ikke fertiliteten hos han- eller hunrotter ved doser på op til 176 og 252 gange den kliniske eksponering hos voksne mennesker baseret på AUC hos hhv. mænd og kvinder (se pkt.
English: The time course of platelet counts in lusutrombopag-treated subjects without platelet transfusion and placebo-treated subjects with platelet transfusion in Studies M0631 and M0634 is presented in Figure 1.
Danish: Tidsforløbet for trombocyttallene hos personer behandlet med lusutrombopag uden trombocyttransfusion og placebobehandlede personer med trombocyttransfusion i studie M0631 og M0634 er vist i figur 1.
English: NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Mulpleo 3 mg filmovertrukne tabletter
English: One patient had mesenteric vein thrombosis reported as a TEAE in the lusutrombopag 4 mg group; two patients had mesenteric vein thrombosis reported as a TEAE in the placebo group (see section 4.4).
Danish: I fase IIb-studiet blev portvenetrombose hos en patient rapporteret som en uønsket hændelse, der opstod under behandlingen (treatment-emergent adverse event, TEAE), i grupperne med lusutrombopag 2 mg og 4 mg. En patient havde mesenterisk venetrombose rapporteret som en TEAE i gruppen med lusutrombopag 4 mg. 2 patienter havde mesenterisk venetrombose rapporteret som en TEAE i placebogruppen (se pkt.
English: Phase 3 Study M0634
Danish: Fase III-studie M0634
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 3 mg lusutrombopag
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 3 mg lusutrombopag
English: if the platelet count reaches ≥50,000/µL as a result of a 20,000/µL increase from baseline.
Danish: ≥ 50.000/µl sammen med en stigning på ≥ 20.000/µl fra baseline.
English: Lusutrombopag did not affect male and female fertility and early embryo development in rats at doses up to 100 mg/kg/day (176 and 252 times respectively, the human clinical exposures in adults based on AUC).
Danish: Lusutrombopag påvirkede ikke fertiliteten hos hanner og hunner og heller ikke den tidligere embryonale udvikling hos rotter ved doser op til 100 mg/kg/dag (hhv. 176 og 252 gange den kliniske eksponering hos voksne mennesker baseret på AUC).
English: In the human mass balance study using [14C]-lusutrombopag, unchanged lusutrombopag (97% of radioactivity in plasma) was the major circulating component, and the metabolites, such as deshexyl, β-oxidated carboxylic acid, taurine conjugate of β-oxidated carboxylic acid, and acyl glucuronide, were detected with less than 2.6% of radioactivity in plasma.
Danish: I det humane masse-balancestudie, hvor der blev brugt [14C]-lusutrombopag, var uændret lusutrombopag (97 % af radioaktiviteten i plasma) den primære kredsløbskomponent, og metabolitter,
English: NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets lusutrombopag
Danish: LÆGEMIDLETS NAVN Mulpleo 3 mg filmovertrukne tabletter lusutrombopag
English: Table 5 Duration of the increase in platelet count to ≥ 50,000/µL
Danish: Tabel 5 Varighed af stigningen i trombocyttal til ≥ 50.000/µl Studie M0631
English: The primary endpoint in Study M0634 was the proportion of subjects who required no platelet transfusion (i.e. achieved platelet count >50,000/µL) before the primary invasive procedure and no rescue therapy for bleeding from randomisation through 7 days after the primary invasive procedure.
Danish: Det primære endepunkt i studie M0634 var andelen af personer, som ikke havde behov for en trombocyttransfusion (dvs. opnåede et trombocyttal på >50.000/µl) før det primære invasive indgreb,
English: Portal vein thrombosis has been reported in Phase 3 randomised, double-blind, placebo-controlled clinical studies with 3 mg of lusutrombopag once daily for up to 7 days (1.2%, 2/171 patients); the incidence was comparable to that of the placebo group (1.2%, 2/170 patients); one case of cardiac ventricular thrombosis was reported (0.6%, 1/171) in the lusutrombopag group only.
Danish: Portvenetrombose er blevet rapporteret i fase III, randomiserede, dobbeltblindede, placebokontrollerede kliniske studier med 3 mg lusutrombopag en gang dagligt i op til 7 dage (1,2 %, 2/171 patienter).
English: Proportion of subjects who required no platelet transfusion during the study (Day 1 through Day 35) The proportion of subjects who required no platelet transfusion during the study was significantly greater in the lusutrombopag groups in the individual studies and the pooled (Studies M0631 and M0634) lusutrombopag group compared with placebo (Table 3).
Danish: Andelen af personer, som ikke havde behov for en trombocyttransfusion i løbet af studiet, var signifikant større i lusutrombopaggrupperne i de individuelle studier og den puljede (studie M0631 og M0634) lusutrombopaggruppe sammenlignet med placebo (tabel 3).
English: Table 2 Proportion of subjects who required no platelet transfusion and no rescue therapy Study M0631
Danish: Tabel 2 Andel af personer, som ikke havde behov for en trombocyttransfusion og ikke fik nødbehandling
English: ≥ 50,000/μL with an increase of ≥ 20,000/μL from baseline) during the study was significantly greater in the lusutrombopag groups in the individual studies and the pooled (Studies M0631 and M0634) lusutrombopag group compared with placebo (Table 4).
Danish: Andelen af personer, som opfyldte kriteriet for respons (defineret som en stigning i trombocyttallet til ≥ 50.000/μl med en stigning på ≥ 20.000/μl fra baseline) i løbet af studiet, var signifikant større i lusutrombopaggrupperne i de individuelle studier og den puljede (studie M0631 og M0634) lusutrombopaggruppe sammenlignet med placebo (tabel 4).
English: What Mulpleo looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Two Phase 3, randomised, double-blind, placebo-controlled studies were conducted to evaluate lusutrombopag versus placebo in thrombocytopenic (platelet count < 50,000/µL) subjects with chronic liver disease (Child-Pugh class A and B), undergoing elective invasive procedures (excluding laparotomy, thoracotomy, craniotomy, open-heart surgery, organ resection, or partial organ resection) in Japan (M0631 (L-PLUS 1)) and multiple countries (M0634 (L-PLUS 2)).
Danish: To fase III, randomiserede, dobbeltblindede, placebokontrollerede studier blev udført for at evaluere lusutrombopag versus placebo hos trombocytopeniske (trombocyttal < 50.000/µl) personer med kronisk leversygdom (Child-Pugh klasse A og B), der gennemgik elektive invasive indgreb (ekskl.
English: Time course of platelet count
Danish: Tidsforløb for trombocyttal
English: • Rash.
Danish: • Udslæt.
English: Breast-feeding
Danish: Portvenetrombose
English: What Mulpleo is and what it is used for What you need to know before you take Mulpleo How to take Mulpleo
Danish: Det skal du vide, før du begynder at tage Mulpleo Sådan skal du tage Mulpleo Bivirkninger
English: Mannitol
Danish: Tabletkerne mannitol
English: Severe hepatic impairment
Danish: Hud og subkutane væv
English: The patients were treated for 4 weeks.
Danish: Patienterne blev behandlet i 4 uger.
English: The recommended dose is one tablet per day for up to 2 weeks until the symptoms are relieved.
Danish: Den anbefalede dosis er én tablet dagligt i op til 2 uger, indtil symptomerne er svundet.
English: The Committee concluded that patients could safely treat themselves with the medicine for up to 2 weeks.
Danish: Udvalget konkluderede, at patienterne uden risiko kunne behandle sig selv med lægemidlet i op til 2 uger.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nexium Control on 26 August 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nexium Control den 26. august 2013.
English: The full EPAR for Nexium Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Nexium Control findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: If symptoms persist after 2 weeks, the patient should see a doctor.
Danish: Hvis symptomerne vedvarer efter 2 uger, bør patienten søge læge.
English: This is a summary of the European public assessment report (EPAR) for Nexium Control.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nexium Control.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nexium Control's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Nexium Control er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The CHMP concluded that the medicine's effects were already well established, as esomeprazole-containing medicines have been authorised in EU countries since 2000, and that its short-term benefits had been demonstrated in studies where most patients' symptoms cleared up in 2 weeks.
Danish: CHMP konkluderede, at lægemidlets virkninger allerede var velkendte, da lægemidler indeholdende esomeprazol har været godkendt i EU siden 2000, og da dets fordele ved kortvarig behandling et påvist i undersøgelser, hvor symptomerne hos størstedelen af patienterne svandt i løbet af 2 uger.
English: Headache, abdominal pain, diarrhoea and nausea are among the most common side effects with Nexium Control (which may affect up to 1 in 10 patients).
Danish: Hovedpine, mavesmerter, diarré og kvalme er blandt de hyppigste bivirkninger ved Nexium Control (kan forekomme hos op til en ud af 10 behandlede).
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining, which pump acid into the stomach.
Danish: Det virker ved at blokere “protonpumperne”, som er proteiner i de specialiserede celler i maveslimhinden, der pumper syre ind i mavesækken.
English: A risk management plan has been developed to ensure that Nexium Control is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Nexium Control anvendes så risikofrit som muligt.
English: Nexium Control has been compared with placebo (a dummy treatment) in two main studies involving 718 adult patients with reflux symptoms including heartburn.
Danish: Nexium Control blev sammenlignet med placebo (virkningsløs behandling) i to hovedundersøgelser med 718 voksne patienter med reflukssymptomer, herunder halsbrand.
English: By blocking the pumps, esomeprazole reduces acid production, thereby relieving the symptoms of acid reflux.
Danish: Ved at blokere pumperne nedsætter esomeprazol syreproduktionen, så symptomerne på syretilbageløb svinder.
English: The reference medicine is only available with a prescription, but Nexium Control is intended for short term use without a prescription.
Danish: Referencelægemidlet fås kun på recept, hvorimod Nexium Control er beregnet til korttidsanvendelse uden recept.
English: The main measure of effectiveness in both studies was the percentage of patients whose heartburn symptoms had completely cleared up at the end of the study.
Danish: I begge undersøgelser blev behandlingens virkning hovedsagelig bedømt på den procentdel af patienterne, hos hvem symptomerne på halsbrand var svundet helt ved undersøgelsens slutning.
English: The active substance in Nexium Control, esomeprazole, is a proton pump inhibitor.
Danish: Det aktive stof i Nexium Control, esomeprazol, er en protonpumpehæmmer.
English: Nexium Control is similar to a ‘reference medicine' already authorized in the European Union (EU) containing the same active substance, called Nexium.
Danish: Nexium Control svarer til et “referencelægemiddel”, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Nexium.
English: What measures are being taken to ensure the safe and effective use of Nexium Control?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nexium Control?
English: Nexium Control is a medicine that contains the active substance esomeprazole.
Danish: Nexium Control er et lægemiddel, der indeholder det aktive stof esomeprazol.
English: For more information about treatment with Nexium Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Nexium Control, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is used in adults for the short-term treatment of reflux symptoms (sometimes called acid reflux), such as heartburn and acid regurgitation.
Danish: Det anvendes til korttidsbehandling af symptomer på refluks (tilbageløb af syre) såsom halsbrand og sure opstød hos voksne.
English: Nexium Control esomeprazole
Danish: Nexium Control esomeprazol
English: It is not intended to provide practical advice on how to use Nexium Control.
Danish: Det er ikke en praktisk vejledning i, hvordan Nexium Control bør anvendes.
English: Nexium Control must not be used together with another medicine called nelfinavir (used to treat HIV infection).
Danish: Nexium Control må ikke anvendes sammen med lægemidlet nelfinavir, der anvendes til behandling af hiv-infektion.
English: Nexium Control can be obtained without a prescription.
Danish: Nexium Control udleveres uden recept.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nexium Control, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Nexium Control er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: Other information about Nexium Control
Danish: Andre oplysninger om Nexium Control:
English: Why is Nexium Control approved?
Danish: Hvorfor blev Nexium Control godkendt?
English: In the first study, around 34% of patients taking a 20 mg dose of Nexium Control (41 out of 121) had no more heartburn symptoms, compared with around 14% of patients taking placebo (17 out of 124).
Danish: I den første undersøgelse svandt symptomerne på halsbrand hos ca. 34 % af de patienter, der fik en dosis af Nexium Control på 20 mg (41 ud af 121), sammenholdt med ca. 14 % af dem, der fik placebo (17 ud af 124).
English: For the full list of all side effects reported with Nexium Control, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Nexium Control fremgår af indlægssedlen.
English: What is Nexium Control and what is it used for?
Danish: Hvad er Nexium Control, og hvad anvendes det til?
English: In the second study, around 42% of patients taking Nexium Control (47 out of 113) had no more heartburn symptoms, compared with around 12% of patients taking placebo (14 out of 118).
Danish: I den anden undersøgelse svandt symptomerne på halsbrand hos ca. 42 % af de patienter, der fik Nexium Control (47 ud af 113), sammenholdt med ca. 12 % af dem, der fik placebo (14 ud af 118).
English: For practical information about using Nexium Control, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Nexium Control, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What are the risks associated with Nexium Control?
Danish: Hvilke risici er der forbundet med Nexium Control?
English: It is available as tablets (20 mg) which are gastro-resistant (the contents pass through the stomach without being broken down until they reach the intestine).
Danish: Enterotabletter er tabletter, hvis indhold passerer gennem mavesækken uden at nedbrydes, før de når frem til tarmen.
English: In both studies, most patients whose symptoms completely cleared up had already achieved this in the first 2 weeks, while patients whose symptoms did not completely clear up in 2 weeks showed little further improvement from continued treatment.
Danish: Hos dem, hvis symptomer ikke svandt fuldstændigt på to uger, var der ingen bedring ved fortsat behandling.
English: How is Nexium Control used?
Danish: Hvordan anvendes Nexium Control?
English: What benefits of Nexium Control have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Nexium Control?
English: How does Nexium Control work?
Danish: Hvordan virker Nexium Control?
English: - You should always keep your alcohol intake to a minimum.
Danish: - Du bør altid holde dit alkoholindtag på et minimum.
English: This combination is, therefore, not recommended.
Danish: Denne kombination anbefales derfor ikke.
English: Povidone K29-32
Danish: Povidon K29-32
English: This is a very rare reaction which can be serious if it occurs.
Danish: Dette er en meget sjælden reaktion, der kan være alvorlig, når den opstår.
English: The following two side effects are important and will require immediate action.
Danish: Følgende bivirkninger er vigtige og kræver omgående handling.
English: These changes are specific to small rodents and have not been observed in other animal species.
Danish: Disse ændringer er specifikke for små gnavere og er ikke blevet observeret hos andre dyrearter.
English: Practically all the drug is eliminated within 6 days.
Danish: Praktisk taget hele lægemidlet udskilles i løbet af 6 dage.
English: B-1080 Brussels
Danish: B-1080 Bruxelles
English: The clinical significance of this is not clear.
Danish: Den kliniske signifikans heraf er uklar.
English: Swallow the capsule with water.
Danish: Synk kapslen med vand.