FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: This medicine has been available since 1981.
Danish: Dette lægemiddel har været på markedet siden 1981.
English: 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.
Danish: 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.
English: It is marketed mainly under the trade names Bezalip, Cedur, Eulitop and Befizal, as well as generic medicines.
Danish: Det markedsføres hovedsagelig under handelsnavnene Bezalip, Cedur, Eulitop og Befizal samt som generiske lægemidler.
English: This medicine has been available since 1995.
Danish: Dette lægemiddel har været på markedet siden 1995.
English: 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.
Danish: Derfor påtog arbejdsgruppen sig at gennemgå fordele og risici ved alle lægemidler indeholdende fibrater.
English: The CHMP looked at the information gathered by PhVWP during its review, as well as the responses provided by the companies to specific questions.
Danish: CHMP gennemgik de oplysninger, som PhVWP havde indsamlet under gennemgangen.
English: • Fenofibrate.
Danish: • Fenofibrat.
English: This medicine has been available since 1975.
Danish: Dette lægemiddel har været på markedet siden 1975.
English: 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.
Danish: 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.
English: • 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.
Danish: Dette gælder navnlig for bestemte grupper af patienter: patienter med svær hypertriglyceridæmi patienter, som ikke må få statiner, eller ikke kan tåle dem
English: It is marketed mainly under the trade name Lipanor or Modalim, as well as generic medicines.
Danish: Det markedsføres hovedsagelig under handelsnavnet Lipanor og Modalim samt som generiske lægemidler.
English: Cyprus, the Czech Republic, Estonia, France, Greece, Hungary, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia and the United Kingdom;
Danish: Det markedsføres i Belgien, Bulgarien, Cypern, Tjekkiet, Estland, Frankrig, Grækenland, Ungarn, Let land, Litauen, Luxembourg, Nederlandene, Polen, Portugal, Rumænien, Slovakiet og Det Forenede Kongerige.
English: It is marketed mainly under the trade name Lopid, as well as generic medicines.
Danish: Det markedsføres hovedsagelig under handelsnavnet Lopid samt som generiske lægemidler.
English: 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.
Danish: Forstyrrelser i blodlipiderne er en risikofaktor for hjerte-kar-sygdom (hjerteanfald og slagtilfælde).
English: This medicine has been available since 1977.
Danish: Dette lægemiddel har været på markedet siden januar 1977.
English: It is marketed mainly under the trade name Lipanthyl, as well as generic medicines.
Danish: Det markedsføres hovedsagelig under handelsnavnet Lipanthyl samt som generiske lægemidler.
English: When the receptors are activated, the break down of fats is accelerated, and this helps clear the blood of cholesterol and triglycerides.
Danish: Når receptorerne aktiveres, øges fedtnedbrydningen.
English: Austria, Belgium, Cyprus, Finland, France, Germany; Greece, Hungary, Italy, Luxembourg,
Danish: Det markedsføres i Østrig, Belgien, Cypern, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Italien, Luxembourg, Malta, Nederlandene, Portugal, Rumænien, Spanien, Sverige og Det Forenede Kongerige.
English: 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.
Danish: De er derfor stadig egnede som førstevalgsbehandling til patienter med svær hypertriglyceridæmi (meget højt indhold af triglycerider i blodet).
English: • Bezafibrate.
Danish: • Bezafibrat.
English: • 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.
Danish: • For patienter, der får fibrater som lipidsænkende behandling, bør lægen tage stilling til, om dette er det mest hensigtsmæssige medicinvalg.
English: Date of first authorisation: 6 January 2011 Date of latest renewal: 5 October 2015
Danish: Dato for første markedsføringstilladelse: 6. januar 2011 Dato for seneste fornyelse: 5. oktober 2015
English: ; - if your blood cell counts are too low.
Danish: − hvis dine blodcelletal er for lave.
English: This condition can be fatal.
Danish: Denne tilstand kan blive dødelig.
English: CI = confidence interval.
Danish: CI = konfidensinterval.
English: You must tell your doctor immediately if you experience any of the following serious side effects.
Danish: Du skal informere din læge straks hvis du oplever nogen af følgende alvorlige bivirkninger.
English: Study results Study GOG-0179
Danish: Tabel 2 Resultater studie GOG-0179
English: Then seek medical evaluation by a physician.
Danish: Søg derefter vurdering hos en læge.
English: Relapsed SCLC
Danish: Relapserende SCLC
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Danish: Da du får denne medicin af en læge eller sygeplejerske, er det usandsynligt, at du får for meget.
English: Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive.
Danish: Fortæl din læge eller sygeplejerske, hvis du er bekymret over den mængde medicin, du får.
English: Potactasol should not be used in pregnant women, unless clearly necessary.
Danish: Potactasol må ikke gives til gravide kvinder, medmindre det er tvingende nødvendigt.
English: Patients who are concerned about their fertility should ask their doctor for counselling on fertility and family planning options prior to starting treatment.
Danish: Patienter, der er bekymrede for deres fertilitet, skal spørge lægen til råds om muligheder for fertilitetsog familieplanlægning, før behandlingen påbegyndes.
English: Median time to progression (weeks)
Danish: Mediantid indtil progression (uger)
English: No in vivo human pharmacokinetic interaction studies have been performed.
Danish: Der er ikke udført “in vivo” humane farmakokinetiske interaktionsstudier.
English: Precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes.
Danish: Der skal udvises forsigtighed for at undgå, at lægemidlet ved et uheld kommer i kontakt med øjnene.
English: Reconstitution and dilution prior to administration
Danish: Rekonstitution og fortynding før administration
English: Adverse reactions are listed below, by system organ class and absolute frequency (all reported events).
Danish: Bivirkningerne nævnt herunder er, opdelt efter systemorganklasse og absolut hyppighed (alle indberettede hændelser).
English: (n = 8), adolescents (n = 3) and young adults (n = 3) with leukaemia.
Danish: (n = 8), unge (n = 3) og yngre voksne (n = 3) med leukæmi.
English: 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.
Danish: 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.
English: Topotecan also had a high volume of distribution, about 132 l, (SD 57), and a relatively short half-life of 2-3 hours.
Danish: Topotecan havde ligeledes et højt distributionsvolumen på omkring 132 l (SD 57), samt en relativ kort halveringstid på 2-3 timer.
English: Anti-tumour activity was demonstrated primarily in patients with neuroblastoma.
Danish: Antitumoraktivitet blev vist primært hos patienter med neuroblastoma.
English: 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).
Danish: 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).
English: Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
Danish: Administration af topotecan til den pædiatriske population er undersøgt, men kun begrænsede data om virkning og sikkerhed er tilgængelige.
English: No studies of the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: Vials 4 years.
Danish: Hætteglas 4 år.
English: - Abnormal high level of bilirubin, a waste product produced by the liver during breakdown of red blood cells.
Danish: - Unormalt højt niveau af bilirubin, et restprodukt som leveren producerer under nedbrydelsen af røde blodceller.
English: 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).
Danish: I et populationsstudie havde et antal faktorer, herunder alder, vægt og ascites ingen signifikant virkning på clearance af total topotecan (aktiv og inaktiv form).
English: If you are given too much Potactasol
Danish: Hvis du får for meget Potactasol
English: extravasation3
Danish: Ekstravasation3
English: Potactasol can make you feel tired or weak.
Danish: Potactasol kan medføre træthed eller svaghed.
English: 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.
Danish: Der sås ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering og der var ingen tegn på ændring i farmakokinetikken efter multiple doser.
English: Your dose of Potactasol may need to be adjusted.
Danish: Det kan være nødvendigt at justere din dosis af Potactasol.
English: 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.
Danish: 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.
English: Cytotoxic, special handling instructions (see package leaflet).
Danish: Cytotoksisk, særlig instruktion (se indlægsseddel).
English: When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Danish: Når topotecan gives sammen med andre kemoterapeutika, kan det være nødvendigt at reducere dosis af de enkelte lægemidler for at forbedre tolerabiliteten.
English: Area under the curve increased approximately in proportion to the increase in dose.
Danish: Arealet under kurven (AUC) øges omtrent proportionalt med dosisforøgelsen.
English: 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).
Danish: 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).
English: 220 Hafnarfjörður Iceland
Danish: 220 Hafnarfjordur Island
English: Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
Danish: Prækliniske studier tyder på, at topotecans plasmaproteinbinding var lav (35 %), og fordelingen mellem blodceller og plasma var rimelig homogen.
English: Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.
Danish: Selvom det ikke vides om topotecan udskilles i human brystmælk, skal amning stoppes ved behandlingsstart.
English: The experience in children and adolescents is limited and treatment is therefore not recommended.
Danish: Erfaringen med behandling af børn og unge er begrænset, og Potactasol frarådes derfor.
English: The second study included a dose range of 2.0 to 5.2 mg/m2 in children
Danish: Det andet studie med et doseringsinterval på 2,0 til 5,2 mg/m2 til børn
English: Pregnant staff should not handle the cytotoxic preparation.
Danish: Gravide kvinder blandt personalet bør ikke arbejde med cytotoksisk præparation.
English: 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.
Danish: 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.
English: 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.
Danish: Hvis du er i behandling for livmoderhalskræft, kan du få bivirkninger af den anden medicin (cisplatin), som du vil få sammen med Potactasol.
English: Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Danish: Hyppigt rapporterede nonhæmatologiske bivirkninger var gastrointestinale, såsom kvalme (52 %), opkastning (32 %), diarre (18 %), obstiptation (9 %) og mucositis (14 %).
English: 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.
Danish: 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.
English: In a population of patients with refractory SCLC (those not responding to first-line therapy), the response rate to topotecan was 4.0 %.
Danish: I en population af patienter med refraktær SCLC (dem som ikke responderer på førstebehandling) var responsraten for topotecan 4,0 %.
English: The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0 %.
Danish: Topotecan-O-glucuronid og N-desmethyl topotecan O glucuronid i urinen var mindre end 2,0 %.
English: − All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Danish: • Alt udstyr brugt til administration eller rengøring, herunder handsker, bør anbringes i en højrisiko-affaldssæk til forbrænding ved høj temperatur.
English: 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.
Danish: 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.
English: In patients refractory to, or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10 %.
Danish: Hos patienter, der var refraktære eller som fik tilbagefald inden for 3 måneder efter cisplatinbehandling (n = 186), var responsraten 10 %.
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Danish: Overordnet genvinding af topotecan-relateret materiale efter fem daglige doser af topotecan var 71 til 76 % af den administrerede intravenøse dosis.
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
Danish: Følgende tumortypervar inkluderet: Ewing's sarkom/primitiv neuroektoderm tumor, neuroblastoma, osteoblastoma og rhabdomyosarcoma.
English: - Swelling caused by fluid build-up (angioedema) e.g. around the eyes and lips as well as hands,
Danish: - Hævelser, der er forårsaget af væskeophobninger (angioødemer) f.eks. rundt om øjne og læber,
English: Ovarian cancer and small cell lung cancer
Danish: Ovariecancer og småcellet lungecancer
English: However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Danish: Forsigtighed bør dog udvises ved kørsel med motorkøretøj eller ved betjening af maskineri, hvis træthed og asteni vedvarer.
English: However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Danish: Topotecan er dog som andre cytostatika genotoksisk, og påvirkning af fertiliteten, herunder den mandlige fertilitet, kan ikke udelukkes.
English: - 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.
Danish: - Milde smerter og betændelse på injektionsstedet p.g.a. forkert injektion af lægemidlet i den omkringliggende hud (extravasation) f.eks. udsivning.
English: The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
Danish: Hyppigheden af alvorlig (grad 3 eller 4) kvalme, opkastning, diarre og mucositis var henholdsvis 4, 3, 2 og 1 %.
English: Potactasol INSTRUCTIONS ON USE
Danish: POTACTASOL INSTRUKTION
English: You must not breast-feed while on treatment with Potactasol.
Danish: Du må ikke amme under behandlingen med Potactasol.
English: Other side effects with Potactasol include: Very common side effects (may affect more than 1 in 10 people)
Danish: Andre bivirkninger med Potactasol inkluderer: Meget almindelige bivirkninger (kan ske hos flere end 1 ud af 10 personer):
English: In this case Potactasol treatment is combined with medicines containing cisplatin.
Danish: I sådanne tilfælde er behandling med Potactasol kombineret med medicin, der indeholder cisplatin.
English: − Pregnant staff should be excluded from working with this medicinal product.
Danish: • Gravide medarbejdere må ikke arbejde med dette lægemiddel.
English: What you need to know before you use Potactasol Do not use Potactasol
Danish: Det skal du vide, før du får Potactasol Du må ikke få Potactasol
English: Read the package leaflet before use.
Danish: Læs pakningens indlægsseddel inden brug.
English: − Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Danish: • Uforvarende berøring med hud eller øjne skal omgående behandles med rigelige mængder vand.
English: Potactasol is used to treat: - ovarian cancer or small cell lung cancer that has come back after chemotherapy - advanced cervical cancer if surgery or radiotherapy is not possible.
Danish: Potactasol bruges til at behandle: - ovariecancer eller - småcellet lungekræft, som er kommet igen efter kemoterapi - fremskreden livmoderhalskræft, hvor behandling med kirurgi eller stråleterapi ikke er mulig.
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Danish: De normale procedurer for korrekt håndtering og bortskaffelse af anticancermedicin skal overholdes,
English: ITT population Cisplatin 50 mg/m2 on day 1, every 21 days
Danish: ITT-population Cisplatin 50 mg/m2 på dag 1, hver 21. dag
English: How Potactasol is prepared
Danish: Hvordan Potactasol tilberedes
English: Overall, the N-desmethyl metabolite contributed a mean of less than 7 % (range 4-9 %) of the total topotecan-related material accounted for in the urine and faeces.
Danish: Samlet set, bidrog N-desmethyl metabolitten i gennemsnit mindre end 7 % (interval 4-9 %) til det topotecan-relaterede materiale i urin og fæces, som der kunne gøres rede for.
English: The overall haematological toxicity is lower in patients treated with topotecan in combination with cisplatin compared to topotecan monotherapy, but higher than with cisplatin alone.
Danish: Den samlede hæmatologiske toksicitet er lavere hos patienter behandlet med topotecan i kombination med cisplatin sammenlignet med topotecan-monotrapi, men højere end med cisplatin alene.
English: Potactasol contains sodium
Danish: Potactasol indeholder natrium
English: In dose-finding studies involving 523 patients with relapsed ovarian cancer and 631 patients with relapsed small cell lung cancer, the dose limiting toxicity of topotecan monotherapy was found to be haematological.
Danish: I studier til dosisbestemmelse omfattende 523 patienter med recidiverende ovariecancer og 631 patienter med recidiverende småcellet lungecancer var den dosisbegrænsende toksicitet af topotecanmonoterapi hæmatologisk.
English: - Feeling generally weak and tired, which can be symptoms of a decrease in the number of red blood cells (anaemia).
Danish: - Generel følelse af slaphed og træthed, som kan være symptomer på fald i antallet af røde blodceller (anæmi).
English: Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Danish: Topotecan er blevet associeret med rapporter om interstitiel lungesygdom (ILD), og nogle af disse tilfælde har været fatale (se pkt.
English: In the oral topotecan plus BSC group there was a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p = 0.0104).
Danish: oral topotecan plus BSC-gruppen var der en statisistiks signifikant forbedring i samlet overlevelse sammenlignet med gruppen med BSC alene (log-rank p = 0,0104).
English: Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Danish: Anæmi: Moderat til alvorlig anæmi (Hb ≤ 8,0 g/dl) hos 37 % af patienterne (14 % af serierne).