natgillin/translations-raw huggingface dataset:
Det vil sige, at de aktiverer receptorer af typen “peroxisom-proliferatoraktiveret receptor”. 
This means that they activate a type of receptor called the ‘peroxisome proliferator activated receptor'.
Udvalget anbefalede konkrete ændringer af informationen til læger og patienter med alle fire fibrater. 
The Committee recommended specific changes to the information to doctors and patients for all four fibrates.
Det markedsføres i alle EU's medlemsstater undtagen Danmark og Nederlandene, desuden i Island og Norge. 
It is sold in all EU Member States except Denmark and the Netherlands, as well as in Iceland and Norway;
Fibrater er “PPAR-agonister”. 
Fibrates are ‘PPAR agonists'.
Hvorfor blev fibrater vurderet igen? 
Why were fibrates reviewed?
Fibrater bør kun anvendes, når statiner er uegnede eller ikke tåles. 
Fibrates should be used only when statins are contraindicated or not tolerated.
Hvad er fibrater? 
What are fibrates?
PhVWP's konklusioner blev overgivet til de virksomheder, der markedsfører fibrater, for at de kunne foretage de ændringer, som arbejdsgruppen havde anbefalet. 
The conclusions of the PhVWP were transmitted to the companies that market fibrates, so that they could implement the changes recommended by the working party.
Det Europæiske Lægemiddelagentur har gennemgået sikkerheden og virkningen af fibrater. 
The European Medicines Agency has completed a review of the safety and effectiveness of fibrates.
Efter vurdering af de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved fibrater inden for disse begrænsninger stadig er større end risiciene. 
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of fibrates continue to outweigh their risks within these restrictions.
Fibrater kan dog anvendes hos patienter, der ikke må få statiner (en anden type lægemidler, der sænker blodlipiderne). 
However, fibrates can be used in patients who cannot take statins (another type of medicine used to lower blood lipid levels).
Udvalget konstaterede desuden, at der er fremkommet nye data om fenofibrat, som støtter en ændring af PhVWP's anbefalinger baseret på resultaterne af undersøgelsen om tillægsbehandling. 
The Committee also noted that there were new data for fenofibrate that supported a change to the PhVWP recommendations, based on the results of the add-on study.
Denne receptor findes mange steder i kroppen, hvor den deltager i nedbrydningen af kostens fedtindhold, specielt triglycerider og kolesterol. 
This receptor can be found in many cells throughout the body, where it is involved in breaking down dietary fat, especially triglycerides and cholesterol.
Derfor tillod udvalget, at fenofibrat under visse omstændigheder bruges sammen med et statin til patienter, der udsættes for risiko, når statiner alene ikke begrænser blodlipiderne tilstrækkeligt. 
As a result, the Committee also allowed the use of fenofibrate together with a statin in some circumstances for patients at risk when using a statin on its own was not enough to completely control blood lipid levels.
Formålet med gennemgangen var at fastlægge, hvordan fibrater bør anvendes, når man tager hensyn til sikkerhed, lipidsænkende evne og tilgængeligheden af andre lipidsænkende lægemidler, der ikke fandtes, da man begyndte at bruge fibrater. 
The aim of the review was to establish how fibrates should now be used, taking into account their safety, their effectiveness in lowering lipid levels and the availability of other lipid-lowering medicines that were not around when fibrates were first used.
Udvalget gennemgik derudover de seneste data fra kliniske undersøgelser, herunder en undersøgelse af fenofibrats virkning som tillægsbehandling til statiner. 
The Committee also looked at the latest data from clinical studies including a trial looking at the effect of using fenofibrate as an ‘add-on' to statins.
Fibrater er en klasse lægemidler, der anvendes til at sænke blodets indhold af lipider såsom kolesterol og triglycerider. 
Fibrates are a class of medicines that can be used to lower the level of lipids, such as cholesterol and triglycerides, in the blood.
Det vil sige, at man ikke skal vælge disse lægemidler som førstevalg til nydiagnosticerede patienter med forstyrrelser i blodlipiderne, medmindre patienten har et meget højt niveau af triglycerider (en type fedtstoffer). 
This means that newlydiagnosed patients with blood lipid disorders should not be treated using these medicines in the first instance, unless they have very high levels of triglycerides (a type of fat).
CHMP's arbejdsgruppe vedrørende lægemiddelovervågning (PhVWP) bemærkede i 2005, at der kun var begrænset dokumentation for fibraters evne til at nedsætte hjerte-kar-risikoen; dette skal sammenholdes med den stærkere dokumentation for statiner (en anden type kolesterolsænkende medicin). 
In 2005, the CHMP's PharmacoVigilance Working Party (PhVWP) noted that there was limited evidence of the long-term benefit of fibrates in reducing cardiovascular risk, compared with the stronger evidence for statins (another type of medicines used for lowering blood cholesterol).
• Patienter, der er i behandling med et fibrat, bør imidlertid aftale en konsultation med lægen for at denne kan afgøre, om lægemidlet er det bedste valg til at sænke blodlipiderne. 
• However, patients taking a fibrate-containing medicine should arrange to see their doctor to check that the medicine is the most appropriate option to lower their blood lipid levels.
Udvalget tilsluttede sig PhVWP's konklusioner om, at fibrater stadig er et sikkert valg til sænkning af lipidindholdet, men at de ikke er berettiget som førstevalgsbehandling. 
The Committee endorsed the conclusions of the PhVWP that fibrates are still a safe option for lowering lipid levels, but that their use as first-line treatment is not justified.
• Patienter, der er i behandling med fibrater for at sænke blodets lipidindhold, skal fortsætte med behandlingen. 
• Patients who are currently taking fibrates to lower their blood lipid levels should continue to do so.
• Ciprofibrat. 
• Ciprofibrate.
Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved fibrater fortsat er større end risiciene, men at de kun i sjældne tilfælde bør være førstevalgsbehandling af forstyrrelser i blodets indhold af lipider (fedtstoffer) såsom forhøjet kolesterol. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of fibrates continue to outweigh their risks but that they should not be used as ‘first line' in the treatment of blood lipids (fats) disorders, such as high cholesterol, except in rare cases.
Derfor henviste Det Forenede Kongeriges lægemiddelstyrelse den 20. oktober 2009 sagen til CHMP og anmodede udvalget om at foretage en gennemgribende vurdering af forholdet mellem fordele og risici for fibrater. 
Consequently, the UK medicines regulatory agency referred the matter to the CHMP on 20 October 2009, to carry out a full assessment of the benefit-risk balance of fibrates and to issue an opinion on whether the marketing authorisations for fibrates-containing medicines should be maintained or varied across the European Union.
Dette lægemiddel har været på markedet siden 1981. 
This medicine has been available since 1981.
PhVWP gennemgik de foreliggende data og konkluderede, at der ikke er nye sikkerhedsproblemer med fibrater, og at fibrater stadig kan være gavnlige til at forbedre lipidniveauet, men at de ikke bør anvendes som førstevalgsbehandling. 
Looking at the data, the PhVWP came to the conclusion that there were no new safety issues with fibrates and that fibrate-containing medicines still had a role to play in improving lipid levels, but that they should not be used as first-line treatment.
Det markedsføres hovedsagelig under handelsnavnene Bezalip, Cedur, Eulitop og Befizal samt som generiske lægemidler. 
It is marketed mainly under the trade names Bezalip, Cedur, Eulitop and Befizal, as well as generic medicines.
Dette lægemiddel har været på markedet siden 1995. 
This medicine has been available since 1995.
Derfor påtog arbejdsgruppen sig at gennemgå fordele og risici ved alle lægemidler indeholdende fibrater. 
As a result the working party undertook a review of the benefits and risks of all fibrates-containing medicines, on behalf of the medicines regulatory authorities of the countries where the medicines are marketed.
CHMP gennemgik de oplysninger, som PhVWP havde indsamlet under gennemgangen. 
The CHMP looked at the information gathered by PhVWP during its review, as well as the responses provided by the companies to specific questions.
• Fenofibrat. 
• Fenofibrate.
Dette lægemiddel har været på markedet siden 1975. 
This medicine has been available since 1975.
Det markedsføres i Østrig, Cypern, Danmark, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Irland, Italien, Nederlandene, Portugal, Slovenien, Slovakiet, Spanien, Sverige og Det Forenede Kongerige Alle disse lægemidler er blevet godkendt via nationale procedurer. 
It is sold in Austria, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, the Netherlands, Portugal, Slovenia, Slovakia, Spain, Sweden and the United Kingdom.
Dette gælder navnlig for bestemte grupper af patienter: patienter med svær hypertriglyceridæmi patienter, som ikke må få statiner, eller ikke kan tåle dem 
• Doctors are reminded that fibrates should not be used as first-line treatment in patients with high lipid levels, except in specific groups: patients with severe hypertriglyceridaemia; patients for whom statins are contra-indicated or who cannot tolerate them.
Det markedsføres hovedsagelig under handelsnavnet Lipanor og Modalim samt som generiske lægemidler. 
It is marketed mainly under the trade name Lipanor or Modalim, as well as generic medicines.
Det markedsføres i Belgien, Bulgarien, Cypern, Tjekkiet, Estland, Frankrig, Grækenland, Ungarn, Let land, Litauen, Luxembourg, Nederlandene, Polen, Portugal, Rumænien, Slovakiet og Det Forenede Kongerige. 
Cyprus, the Czech Republic, Estonia, France, Greece, Hungary, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia and the United Kingdom;
Det markedsføres hovedsagelig under handelsnavnet Lopid samt som generiske lægemidler. 
It is marketed mainly under the trade name Lopid, as well as generic medicines.
Forstyrrelser i blodlipiderne er en risikofaktor for hjerte-kar-sygdom (hjerteanfald og slagtilfælde). 
Blood lipid disorders are a risk factor of heart disease (such as heart attack and stroke) and fibrates are used to improve lipid levels in patients in whom dietary restrictions and exercise have not been enough.
Dette lægemiddel har været på markedet siden januar 1977. 
This medicine has been available since 1977.
Det markedsføres hovedsagelig under handelsnavnet Lipanthyl samt som generiske lægemidler. 
It is marketed mainly under the trade name Lipanthyl, as well as generic medicines.
Når receptorerne aktiveres, øges fedtnedbrydningen. 
When the receptors are activated, the break down of fats is accelerated, and this helps clear the blood of cholesterol and triglycerides.
Det markedsføres i Østrig, Belgien, Cypern, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Italien, Luxembourg, Malta, Nederlandene, Portugal, Rumænien, Spanien, Sverige og Det Forenede Kongerige. 
Austria, Belgium, Cyprus, Finland, France, Germany; Greece, Hungary, Italy, Luxembourg,
De er derfor stadig egnede som førstevalgsbehandling til patienter med svær hypertriglyceridæmi (meget højt indhold af triglycerider i blodet). 
However, the Committee noted that fibrates are more effective than statins in lowering triglyceride levels and therefore their use as a first-line treatment in patients with severe hypertriglyceridaemia (very high blood levels of triglycerides) is still appropriate.
• Bezafibrat. 
• Bezafibrate.
• For patienter, der får fibrater som lipidsænkende behandling, bør lægen tage stilling til, om dette er det mest hensigtsmæssige medicinvalg. 
• They should review the treatment of patients who are receiving fibrates to help control their lipid levels to ensure that the patient is receiving the most appropriate treatment.
Dato for første markedsføringstilladelse: 6. januar 2011 Dato for seneste fornyelse: 5. oktober 2015 
Date of first authorisation: 6 January 2011 Date of latest renewal: 5 October 2015
− hvis dine blodcelletal er for lave. 
; - if your blood cell counts are too low.
Denne tilstand kan blive dødelig. 
This condition can be fatal.
CI = konfidensinterval. 
CI = confidence interval.
Du skal informere din læge straks hvis du oplever nogen af følgende alvorlige bivirkninger. 
You must tell your doctor immediately if you experience any of the following serious side effects.
Tabel 2 Resultater studie GOG-0179 
Study results Study GOG-0179
Søg derefter vurdering hos en læge. 
Then seek medical evaluation by a physician.
Relapserende SCLC 
Relapsed SCLC
Da du får denne medicin af en læge eller sygeplejerske, er det usandsynligt, at du får for meget. 
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Fortæl din læge eller sygeplejerske, hvis du er bekymret over den mængde medicin, du får. 
Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive.
Potactasol må ikke gives til gravide kvinder, medmindre det er tvingende nødvendigt. 
Potactasol should not be used in pregnant women, unless clearly necessary.
Patienter, der er bekymrede for deres fertilitet, skal spørge lægen til råds om muligheder for fertilitetsog familieplanlægning, før behandlingen påbegyndes. 
Patients who are concerned about their fertility should ask their doctor for counselling on fertility and family planning options prior to starting treatment.
Mediantid indtil progression (uger) 
Median time to progression (weeks)
Der er ikke udført “in vivo” humane farmakokinetiske interaktionsstudier. 
No in vivo human pharmacokinetic interaction studies have been performed.
Der skal udvises forsigtighed for at undgå, at lægemidlet ved et uheld kommer i kontakt med øjnene. 
Precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes.
Rekonstitution og fortynding før administration 
Reconstitution and dilution prior to administration
Bivirkningerne nævnt herunder er, opdelt efter systemorganklasse og absolut hyppighed (alle indberettede hændelser). 
Adverse reactions are listed below, by system organ class and absolute frequency (all reported events).
(n = 8), unge (n = 3) og yngre voksne (n = 3) med leukæmi. 
(n = 8), adolescents (n = 3) and young adults (n = 3) with leukaemia.
En læge eller en sygeplejerske vil give dig den tilberedte og fortyndede Potactasol opløsning som infusion (drop), sædvanligvis i armen over en periode på ca. 30 minutter. 
A doctor or nurse will give you the reconstituted and diluted Potactasol solution as an infusion (drip), usually into your arm, over about 30 minutes.
Topotecan havde ligeledes et højt distributionsvolumen på omkring 132 l (SD 57), samt en relativ kort halveringstid på 2-3 timer. 
Topotecan also had a high volume of distribution, about 132 l, (SD 57), and a relatively short half-life of 2-3 hours.
Antitumoraktivitet blev vist primært hos patienter med neuroblastoma. 
Anti-tumour activity was demonstrated primarily in patients with neuroblastoma.
Som det ville være forventet har patienter med dårlig performancestatus (PS ≥ 1) en lavere responsrate og en øget forekomst af komplikationer såsom feber, infektion og sepsis (se pkt 4.8). 
As would be expected, patients with poor performance status (PS > 1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Administration af topotecan til den pædiatriske population er undersøgt, men kun begrænsede data om virkning og sikkerhed er tilgængelige. 
Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner. 
No studies of the effects on the ability to drive and use machines have been performed.
Hætteglas 4 år. 
Vials 4 years.
- Unormalt højt niveau af bilirubin, et restprodukt som leveren producerer under nedbrydelsen af røde blodceller. 
- Abnormal high level of bilirubin, a waste product produced by the liver during breakdown of red blood cells.
I et populationsstudie havde et antal faktorer, herunder alder, vægt og ascites ingen signifikant virkning på clearance af total topotecan (aktiv og inaktiv form). 
In a population study, a number of factors including age, weight and ascites had no significant effect on clearance of total topotecan (active and inactive form).
Hvis du får for meget Potactasol 
If you are given too much Potactasol
Ekstravasation3 
extravasation3
Potactasol kan medføre træthed eller svaghed. 
Potactasol can make you feel tired or weak.
Der sås ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering og der var ingen tegn på ændring i farmakokinetikken efter multiple doser. 
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the pharmacokinetics after multiple doses.
Det kan være nødvendigt at justere din dosis af Potactasol. 
Your dose of Potactasol may need to be adjusted.
Patienter bør monitoreres for pulmonale symptomer, der indikerer (ILD) (eks. hoste, feber, dyspnø og/eller hypoxia), og topetecan bør seponeres, hvis en ny diagnose af ILD bekræftes. 
Patients should be monitored for pulmonary symptoms indicative of ILD (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Cytotoksisk, særlig instruktion (se indlægsseddel). 
Cytotoxic, special handling instructions (see package leaflet).
Når topotecan gives sammen med andre kemoterapeutika, kan det være nødvendigt at reducere dosis af de enkelte lægemidler for at forbedre tolerabiliteten. 
When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Arealet under kurven (AUC) øges omtrent proportionalt med dosisforøgelsen. 
Area under the curve increased approximately in proportion to the increase in dose.
til < 1/10), ikke almindelig (≥ 1/1.000, til < 1/100), sjælden (≥ 1/10.000, til < 1/1.000), meget sjælden (< 1/10.000), og ikke kendte (kan ikke estimeres ud fra forhåndenværende data). 
Frequencies are defined as: very common (≥ 1/10), 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) and not known (cannot be estimated from the available data).
Prækliniske studier tyder på, at topotecans plasmaproteinbinding var lav (35 %), og fordelingen mellem blodceller og plasma var rimelig homogen. 
Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
Selvom det ikke vides om topotecan udskilles i human brystmælk, skal amning stoppes ved behandlingsstart. 
Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.
Erfaringen med behandling af børn og unge er begrænset, og Potactasol frarådes derfor. 
The experience in children and adolescents is limited and treatment is therefore not recommended.
Det andet studie med et doseringsinterval på 2,0 til 5,2 mg/m2 til børn 
The second study included a dose range of 2.0 to 5.2 mg/m2 in children
Gravide kvinder blandt personalet bør ikke arbejde med cytotoksisk præparation. 
Pregnant staff should not handle the cytotoxic preparation.
In vitro hæmmede topotecan hverken de menneskelige P450-enzymer CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A og CYP4A eller de menneskelige cytosoliske enzymer dihydropyrimidin eller xanthinoxidase. 
In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Hvis du er i behandling for livmoderhalskræft, kan du få bivirkninger af den anden medicin (cisplatin), som du vil få sammen med Potactasol. 
If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Potactasol.
Hyppigt rapporterede nonhæmatologiske bivirkninger var gastrointestinale, såsom kvalme (52 %), opkastning (32 %), diarre (18 %), obstiptation (9 %) og mucositis (14 %). 
Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
I kliniske studier blev topotecanbehandlingen stoppet, hvis dosis var blevet reduceret til 1,0 mg/m2/dag og yderligere reduktion af dosis var nødvendig, for at håndtere bivirkninger. 
In clinical studies, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2/day and a further dose reduction was required to manage adverse effects.
I en population af patienter med refraktær SCLC (dem som ikke responderer på førstebehandling) var responsraten for topotecan 4,0 %. 
In a population of patients with refractory SCLC (those not responding to first-line therapy), the response rate to topotecan was 4.0 %.
Topotecan-O-glucuronid og N-desmethyl topotecan O glucuronid i urinen var mindre end 2,0 %. 
The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0 %.
• Alt udstyr brugt til administration eller rengøring, herunder handsker, bør anbringes i en højrisiko-affaldssæk til forbrænding ved høj temperatur. 
− All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
En N-desmethyl metabolit, som i et cellebaseret assay har vist sig at have samme eller mindre aktivitet end lægemiddelstoffet, er fundet i urin, plasma og fæces. 
An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma, and faeces.
Hos patienter, der var refraktære eller som fik tilbagefald inden for 3 måneder efter cisplatinbehandling (n = 186), var responsraten 10 %. 
In patients refractory to, or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10 %.
Overordnet genvinding af topotecan-relateret materiale efter fem daglige doser af topotecan var 71 til 76 % af den administrerede intravenøse dosis. 
Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Følgende tumortypervar inkluderet: Ewing's sarkom/primitiv neuroektoderm tumor, neuroblastoma, osteoblastoma og rhabdomyosarcoma. 
Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
- Hævelser, der er forårsaget af væskeophobninger (angioødemer) f.eks. rundt om øjne og læber, 
- Swelling caused by fluid build-up (angioedema) e.g. around the eyes and lips as well as hands,
Ovariecancer og småcellet lungecancer 
Ovarian cancer and small cell lung cancer
Forsigtighed bør dog udvises ved kørsel med motorkøretøj eller ved betjening af maskineri, hvis træthed og asteni vedvarer. 
However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Topotecan er dog som andre cytostatika genotoksisk, og påvirkning af fertiliteten, herunder den mandlige fertilitet, kan ikke udelukkes. 
However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
- Milde smerter og betændelse på injektionsstedet p.g.a. forkert injektion af lægemidlet i den omkringliggende hud (extravasation) f.eks. udsivning. 
- Mild pain and inflammation at the site of injection due to accidental administration of the medicinal product into the surrounding tissue (extravasation) e.g. by leakage.