natgillin/translations-raw huggingface dataset:
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, 
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.
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). 
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.
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). 
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).
Tabel 2 Andel af personer, som ikke havde behov for en trombocyttransfusion og ikke fik nødbehandling 
Table 2 Proportion of subjects who required no platelet transfusion and no rescue therapy Study M0631
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). 
≥ 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).
Udseende og pakningsstørrelser 
What Mulpleo looks like and contents of the pack
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. 
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)).
Tidsforløb for trombocyttal 
Time course of platelet count
• Udslæt. 
• Rash.
Portvenetrombose 
Breast-feeding
Det skal du vide, før du begynder at tage Mulpleo Sådan skal du tage Mulpleo Bivirkninger 
What Mulpleo is and what it is used for What you need to know before you take Mulpleo How to take Mulpleo
Tabletkerne mannitol 
Mannitol
Hud og subkutane væv 
Severe hepatic impairment
Patienterne blev behandlet i 4 uger. 
The patients were treated for 4 weeks.
Den anbefalede dosis er én tablet dagligt i op til 2 uger, indtil symptomerne er svundet. 
The recommended dose is one tablet per day for up to 2 weeks until the symptoms are relieved.
Udvalget konkluderede, at patienterne uden risiko kunne behandle sig selv med lægemidlet i op til 2 uger. 
The Committee concluded that patients could safely treat themselves with the medicine for up to 2 weeks.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nexium Control den 26. august 2013. 
The European Commission granted a marketing authorisation valid throughout the European Union for Nexium Control on 26 August 2013.
Den fuldstændige EPAR for Nexium Control findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
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.
Hvis symptomerne vedvarer efter 2 uger, bør patienten søge læge. 
If symptoms persist after 2 weeks, the patient should see a doctor.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nexium Control. 
This is a summary of the European public assessment report (EPAR) for Nexium Control.
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. 
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.
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. 
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.
Hovedpine, mavesmerter, diarré og kvalme er blandt de hyppigste bivirkninger ved Nexium Control (kan forekomme hos op til en ud af 10 behandlede). 
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).
Det virker ved at blokere “protonpumperne”, som er proteiner i de specialiserede celler i maveslimhinden, der pumper syre ind i mavesækken. 
It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining, which pump acid into the stomach.
Der er udarbejdet en risikostyringsplan for at sikre, at Nexium Control anvendes så risikofrit som muligt. 
A risk management plan has been developed to ensure that Nexium Control is used as safely as possible.
Nexium Control blev sammenlignet med placebo (virkningsløs behandling) i to hovedundersøgelser med 718 voksne patienter med reflukssymptomer, herunder halsbrand. 
Nexium Control has been compared with placebo (a dummy treatment) in two main studies involving 718 adult patients with reflux symptoms including heartburn.
Ved at blokere pumperne nedsætter esomeprazol syreproduktionen, så symptomerne på syretilbageløb svinder. 
By blocking the pumps, esomeprazole reduces acid production, thereby relieving the symptoms of acid reflux.
Referencelægemidlet fås kun på recept, hvorimod Nexium Control er beregnet til korttidsanvendelse uden recept. 
The reference medicine is only available with a prescription, but Nexium Control is intended for short term use without a prescription.
I begge undersøgelser blev behandlingens virkning hovedsagelig bedømt på den procentdel af patienterne, hos hvem symptomerne på halsbrand var svundet helt ved undersøgelsens slutning. 
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.
Det aktive stof i Nexium Control, esomeprazol, er en protonpumpehæmmer. 
The active substance in Nexium Control, esomeprazole, is a proton pump inhibitor.
Nexium Control svarer til et “referencelægemiddel”, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Nexium. 
Nexium Control is similar to a ‘reference medicine' already authorized in the European Union (EU) containing the same active substance, called Nexium.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nexium Control? 
What measures are being taken to ensure the safe and effective use of Nexium Control?
Nexium Control er et lægemiddel, der indeholder det aktive stof esomeprazol. 
Nexium Control is a medicine that contains the active substance esomeprazole.
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. 
For more information about treatment with Nexium Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det anvendes til korttidsbehandling af symptomer på refluks (tilbageløb af syre) såsom halsbrand og sure opstød hos voksne. 
It is used in adults for the short-term treatment of reflux symptoms (sometimes called acid reflux), such as heartburn and acid regurgitation.
Nexium Control esomeprazol 
Nexium Control esomeprazole
Det er ikke en praktisk vejledning i, hvordan Nexium Control bør anvendes. 
It is not intended to provide practical advice on how to use Nexium Control.
Nexium Control må ikke anvendes sammen med lægemidlet nelfinavir, der anvendes til behandling af hiv-infektion. 
Nexium Control must not be used together with another medicine called nelfinavir (used to treat HIV infection).
Nexium Control udleveres uden recept. 
Nexium Control can be obtained without a prescription.
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. 
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.
Andre oplysninger om Nexium Control: 
Other information about Nexium Control
Hvorfor blev Nexium Control godkendt? 
Why is Nexium Control approved?
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). 
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).
Den fuldstændige liste over indberettede bivirkninger ved Nexium Control fremgår af indlægssedlen. 
For the full list of all side effects reported with Nexium Control, see the package leaflet.
Hvad er Nexium Control, og hvad anvendes det til? 
What is Nexium Control and what is it used for?
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). 
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).
Hvis du ønsker praktisk vejledning om anvendelsen af Nexium Control, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Nexium Control, patients should read the package leaflet or contact their doctor or pharmacist.
Hvilke risici er der forbundet med Nexium Control? 
What are the risks associated with Nexium Control?
Enterotabletter er tabletter, hvis indhold passerer gennem mavesækken uden at nedbrydes, før de når frem til tarmen. 
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).
Hos dem, hvis symptomer ikke svandt fuldstændigt på to uger, var der ingen bedring ved fortsat behandling. 
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.
Hvordan anvendes Nexium Control? 
How is Nexium Control used?
Hvilke fordele viser undersøgelserne, at der er ved Nexium Control? 
What benefits of Nexium Control have been shown in studies?
Hvordan virker Nexium Control? 
How does Nexium Control work?
- Du bør altid holde dit alkoholindtag på et minimum. 
- You should always keep your alcohol intake to a minimum.
Denne kombination anbefales derfor ikke. 
This combination is, therefore, not recommended.
Povidon K29-32 
Povidone K29-32
Dette er en meget sjælden reaktion, der kan være alvorlig, når den opstår. 
This is a very rare reaction which can be serious if it occurs.
Følgende bivirkninger er vigtige og kræver omgående handling. 
The following two side effects are important and will require immediate action.
Disse ændringer er specifikke for små gnavere og er ikke blevet observeret hos andre dyrearter. 
These changes are specific to small rodents and have not been observed in other animal species.
Praktisk taget hele lægemidlet udskilles i løbet af 6 dage. 
Practically all the drug is eliminated within 6 days.
B-1080 Bruxelles 
B-1080 Brussels
Den kliniske signifikans heraf er uklar. 
The clinical significance of this is not clear.
Synk kapslen med vand. 
Swallow the capsule with water.
Det kan være nødvendigt med ekstra prøver og lægemidler for at stille diagnosen og behandle det. 
Additional tests and medicines may be needed to diagnose and treat this.
De kan øge din risiko for at få hjerteproblemer. 
They may raise your risk of having heart problems.
- Fortæl lægen om alle dine sygdomme, også allergier. 
- Tell your doctor about all your medical conditions including allergies.
Hvad bør jeg vide om kolesterol og triglycerider? 
What should I know about cholesterol and triglycerides?
Mekanismen bag denne interaktion (hvorvidt den er farmakodynamisk eller farmakokinetisk eller begge dele) er endnu ukendt. 
The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown.
Fordelingsvolumen er ca. 0,5 l/kg. 
The volume of distribution is about 0.5 l/kg.
- Du er over 70 år gammel. 
- You are under 18 years old.
Dette har ingen relevans for den terapeutiske brug hos mennesker. 
This is of no relevance to therapeutic use in man.
Bivirkningerne var som regel milde og forbigående. 
Adverse reactions have usually been mild and transient.
Dette skyldes måltidets fedtindhold. 
This is due to the fat content of the meal.
Din læge vil overvåge dit helbred, imens du tager dette lægemiddel. 
Your doctor will monitor you while you are taking this medicine.
Det anbefales at foretage en klinisk og biokemisk monitorering af patienter, som får denne kombination. 
Clinical and biochemical monitoring of patients receiving this combination is recommended.
Pædiatrisk population (< 18 år) 
Paediatric population (< 18 years old)
Tag ikke Pravafenix, hvis du er gravid eller forsøger at blive gravid, eller hvis du tror, at du måske kan være gravid. 
Do not take Pravafenix if you are pregnant or trying to get pregnant or think you may be pregnant.
Kravene til indsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel, er fastsat i listen over EU-referencedatoer (EURD liste), der er fastsat i henhold til artikel 107c(7), i direktiv 2001/83/EF, og enhver efterfølgende opdatering offentliggjort på den europæiske webportal om lægemidler. 
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Risikoen for muskelnedbrydning er større hos nogle patienter. 
The risk of muscle breakdown is greater in certain patients.
- Børn og unge (under 18 år). 
- Children and adolescents (age below 18 years).
Hvis CK-niveauerne er signifikant forhøjede, dvs. > 5 gange ULN ved baseline, bør resultaterne kontrolleres efter 5-7 dage. 
If CK levels are significantly elevated > 5 times the ULN at baseline, the results should be controlled after 5-7 days.
I sådanne tilfælde skal CK-niveauerne måles. 
In these cases, CK levels should be measured.
Når blodtilstrømningen blokeres, kan resultatet være et hjerteanfald eller et slagtilfælde. 
When the blood flow is blocked, the result can be a heart attack or stroke.
Det anbefales, at dosis af antikoagulantia reduceres med ca. en tredjedel i starten af behandlingen og om nødvendigt justeres gradvist i henhold til monitoreringen af INR (International Normalised Ratio). 
It is recommended that the dose of anticoagulants is reduced by about one third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring.
Denne tilstopning kan forsinke eller blokere blodtilstrømningen til vitale organer som hjertet og hjernen. 
This clogging can slow or block blood flow to vital organs such as the heart and brain.
I sådanne tilfælde skal CK-niveauerne måles (se nedenfor). 
In such cases CK levels should be measured (see below).
LDL- og VLDL-triglycerider reduceres. 
LDL and VLDL triglycerides are reduced.
Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis, men skal blot tage den normale mængde Pravafenix på det sædvanlige tidspunkt næste dag. 
Do not take a double dose to make up for a forgotten dose, just take your normal amount of Pravafenix at the usual time the next day.
Pravastatin indgives oralt i den aktive form. 
Pravastatin is administered orally in the active form.
Træthed og vertigo 
Fatigue and vertigo
Inden behandlingens påbegyndelse 
Before treatment initiation
Det er vigtigt at tage kapslen med mad, eftersom den ikke virker lige så godt på tom mave. 
It is important to take the capsule with food, as it won't work as well if your stomach is empty.
Undersøgelser hos mus, rotter og kaniner har ikke vist nogen teratogen virkning. 
Studies in mice, rats and rabbits did not reveal any teratogenic effect.
Polyamid-aluminium-PVC/aluminium blisterpakninger 2 år. 
Polyamide-Aluminium-PVC/aluminium blister 2 years.
Hvis du planlægger at blive gravid eller bliver gravid, skal du straks fortælle det til din læge. 
If you plan to become pregnant or become pregnant, inform your doctor immediately.
Der er ingen specifik modgift. 
No specific antidote is known.
I kliniske undersøgelser fik over 1 566 patienter Pravafenix. 
In clinical trials, over 1,566 patients received Pravafenix.
CK-niveauernes baselineværdier kan ligeledes være nyttige som reference, såfremt der sker en senere stigning under kombinationsbehandlingen. 
The baseline CK levels may also be useful as a reference in the event of a later increase during the combination therapy.
1/100 til < 1/10), ikke almindelig (≥ 1/1 000 til < 1/100), sjælden (≥ 1/10 000 til < 1/1 000), meget sjælden (< 1/10 000). 
Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000).
Dette blev ikke observeret i den førnævnte undergruppe af patienter med dyslipidæmi, men der var heller ikke noget klart bevis for fordelen hos dyslipidæmiske kvinder behandlet med fenofibrat plus simvastatin, og en mulig skadelig effekt i denne undergruppe kunne ikke udelukkes. 
This was not observed in the aforementioned subgroup of patients with dyslipidaemia but there was also no clear evidence of benefit in dyslipidaemic women treated with fenofibrate plus simvastatin, and a possible harmful effect in this subgroup could not be excluded.
Hvis de bekræftes, må behandlingen definitivt ikke påbegyndes (se pkt. 
If confirmed, the treatment should definitively not be initiated (see section 4.3).
Hvis du er usikker på, hvor meget alkohol du kan drikke, mens du tager dette lægemiddel, skal du tale med din læge. 
If you are concerned about how much alcohol you can drink while you are taking this medicine, you should discuss this with your doctor.
Maksimale plasmakoncentrationer (Cmax) optræder senest 4-5 timer efter oral indgivelse. 
Maximum plasma concentrations (Cmax) occur within 4 to 5 hours after oral administration.
De indberettede tilfælde af overdosering var asymptomatiske og gav ikke anledning til unormale laboratorieprøver. 
Reported cases of overdose were asymptomatic and did not give rise to abnormal laboratory tests.
HDPE-beholdere3 år. 
HDPE bottle 3 years.
Kombinationen er ikke blevet testet i reproduktionstoksicitetsundersøgelser. 
The combination has not been tested in reproductive toxicity studies.
I gennemsnit absorberes 34 % af den oralt indgivne dosis med en absolut biotilgængelighed på 17 %. 
On average, 34% of the orally administered dose is absorbed, with an absolute bioavailability of 17%.
Tag ikke Pravafenix, hvis noget af ovenstående gælder for dig. 
Do not take Pravafenix if any of the above applies to you.
Biologisk omdannelse og elimination 
Biotransformation and elimination
- For at øge niveauet af det "gode" kolesterol (HDL-kolesterol). 
- To raise the level of your ‘good' cholesterol (HDL cholesterol).
Plasmakoncentrationerne er stabile under fortsat behandling hos en hvilken som helst person. 
Plasma concentrations are stable during continuous treatment in any given individual.
Selv om disse ændringer var små, bør der udvises forsigtighed, når pravastatin bruges samtidig med erythromycin eller clarithromycin. 
Although these changes were minor, caution should be exercised when associating pravastatin with erythromycin or clarithromycin.
Med tiden kan dannelsen af sådanne belægninger føre til tilstopning af dine arterier. 
Over time, this plaque build-up can lead to a clogging of your arteries.
Brug ikke Pravafenix efter den udløbsdato, der står på æsken og blisterkortet/beholderen efter EXP. 
Do not use Pravafenix after the expiry date which is stated on the carton and the blister/bottle after EXP.
Fortæl det straks til lægen, hvis denne reaktion opstår. 
You should tell your doctor immediately if it happens.
Denne risiko opvejes dog af, at statiner reducerer den vaskulære risiko, og bør derfor ikke være grund til seponering af statin. 
This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment.
Hos nogle patienter kan stigningen i eksponeringen for pravastatin dog være større. 
In some patients, however, the increase in pravastatin exposure may be larger.
Se også punkt 4 i denne indlægsseddel. 
Also see section 4 of this leaflet.
Den øgede risiko for venøse trombotiske hændelser kan være forbundet med det øgede homocysteinniveau, som er en risikofaktor for trombose, og andre uidentificerede faktorer. 
The increased risk of venous thrombotic events may be related to the increased homocysteine level, a risk factor for thrombosis and other unidentified factors.
Stigningen i AUC∞, AUCt og Cmax ligger på henholdsvis 111,88 %, 114,06 % og 115,28 %. 
∞, AUCt, and Cmax is of 111.88%, 114.06%, and 115.28% respectively.
Fenofibrat Fenofibrinsyre bindes stærkt til plasmaalbumin (over 99 %). 
Fenofibrate Fenofibric acid is strongly bound to plasma albumin (more than 99%).
Hvis du oplever nogen form for svimmelhed, sløret syn eller dobbeltsyn under behandlingen, skal du sikre dig, at du er i stand til at føre motorkøretøj eller betjene maskiner, inden du forsøger at gøre dette. 
If you experience any dizziness, blurred or double vision during treatment, make sure you are fit to drive and use machines before attempting to do so.
Børn Tag ikke Pravafenix, hvis du er under 18 år. 
Children and adolescents Do not take Pravafenix if you are under 18 years old
14 hårde kapsler 30 hårde kapsler 60 hårde kapsler 90 hårde kapsler 
14 hard capsules 30 hard capsules 60 hard capsules 90 hard capsules