FrancophonIA/ELRC3.0 huggingface dataset:
English: It looked at data on 10,000 adults who started treatment between 1985 and 1996, using a mandatory national registry.
Danish: Undersøgelsen var baseret på oplysninger om 10 000 voksne personer, der var begyndt på behandlingen mellem 1985 og 1996.
English: The CHMP also looked into additional data from the unpublished French SAGhE study.
Danish: CHMP gennemgik desuden supplerende data fra den endnu ikke offentliggjorte franske SAGhE-undersøgelse.
English: Further mortality data from the European SAGhE study will be available by the end of 2012, and the CHMP considered an analysis of these results to be essential to address any concerns raised by the French study.
Danish: Inden udgangen af 2012 vil der være fremkommet yderligere oplysninger om dødelighed fra den europæiske SAGhE-undersøgelse, og CHMP fandt, at en analyse af disse resultater vil være væsentlig i forbindelse med eventuelle betænkeligheder, der måtte blive rejst i forbindelse med den franske undersøgelse.
English: Consequently, in December 2010 the French agency asked the CHMP to issue an opinion on the impact of these data on the benefit-risk balance of somatropin-containing medicines, and on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Danish: Som følge heraf anmodede den franske lægemiddelstyrelse i december 2010 CHMP om at fremsætte en udtalelse om, hvilken betydning disse oplysninger havde for forholdet mellem fordele og risici ved lægemidler indeholdende somatropin, og tage stilling til, om markedsføringstilladelserne for disse lægemidler burde opretholdes, ændres, suspenderes eller tilbagetrækkes i hele EU.
English: In December 2010, the French medicines regulatory agency was made aware of preliminary results of a long-term population-based study in France of patients treated during childhood with somatropincontaining medicines.
Danish: I december 2010 blev den franske lægemiddelstyrelse gjort opmærksom på de foreløbige resultater af en langsigtet befolkningsgruppeundersøgelse i Frankrig af patienter, der som børn var blevet behandlet med lægemidler indeholdende somatropin.
English: The CHMP reviewed the available data on the safety of somatropin-containing medicines, including data from clinical trials, registries, and observational studies, as well as reports of side effects from post-marketing surveillance.
Danish: CHMP gennemgik de foreliggende oplysninger om lægemidler indeholdende somatropin, herunder oplysninger fra kliniske undersøgelser, registre og observationsundersøgelser samt indberetninger af bivirkninger fra overvågning efter markedsføring.
English: Growth hormone promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fats and carbohydrates.
Danish: Væksthormon fremmer væksten hos børn og unge og har desuden betydning for stofskiftet af proteiner, fedtstoffer og kulhydrater.
English: However, to ensure that somatropin-containing medicines are used appropriately, the CHMP recommended that specific wording be included in the product information of all somatropin-containing medicines.
Danish: For at sikre, at lægemidler indeholdende somatropin anvendes på en hensigtsmæssig måde, anbefalede CHMP dog, at der indsættes en særlig ordlyd i produktinformationen for alle lægemidler indeholdende somatropin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of somatropin continue to outweigh its risks, but recommended changes to the product information to ensure that somatropin-containing medicines are used appropriately.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved somatropin fortsat overstiger risiciene, men anbefalede, at produktinformationen ændres for at sikre, at lægemidler indeholdende somatropin anvendes korrekt.
English: They have been authorised in the EU since the 1980s through centralised or national procedures.2 The approved indications vary for the different somatropin-containing medicines: they may be used as hormone replacement therapy, and to correct short stature (height) in children with certain genetic diseases (Turner syndrome or Prader Willi syndrome), children who have long-standing kidney problems and children born small for their gestational age.
Danish: De godkendte indikationer varierer for de forskellige lægemidler indeholdende somatropin: De kan anvendes som hormonerstatning og til behandling af lav højde hos børn med visse arvelige sygdomme (Turners syndrom eller Prader-Willis syndrom), til langvarige nyreproblemer hos børn og til behandling af børn, der er født for små i forhold til fosteralderen.
English: The European Medicines Agency has completed a review of the safety and effectiveness of somatropincontaining medicines, following the results of a French study which suggested an increased risk of mortality in patients treated with somatropin compared with the general population.
Danish: Det Europæiske Lægemiddelagentur har gennemgået sikkerheden og effektiviteten af lægemidler indeholdende somatropin, efter at en fransk undersøgelse har givet resultater, der tyder på højere dødelighed hos patienter, der er behandlet med somatropin, end i den almindelige befolkning.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefit-risk balance of somatropin-containing medicines remains positive when used in the approved indications at the approved doses.
Danish: Efter at have vurderet de foreliggende data og efter den videnskabelige drøftelse i udvalget konkluderede CHMP, at forholdet mellem fordele og risici ved lægemidler indeholdende somatropin fortsat er positivt, når de anvendes til de godkendte indikationer og i den godkendte dosering.
English: After assessing all other available safety data on somatropin, the CHMP concluded that the potential signal of an increased risk of mortality seen in the French study is not corroborated by any other data, and that the benefit-risk balance of somatropincontaining medicines has not changed.
Danish: Efter at have gennemgået alle andre foreliggende sikkerhedsdata om somatropin konkluderede CHMP, at ingen andre data bekræfter de mulige signaler om øget dødelighed fra den franske undersøgelse, og at der ikke er ændret på forholdet mellem fordele og risici ved lægemidler indeholdende somatropin.
English: The study, called ‘Santé Adulte GH Enfant' (SAGhE) study, was initiated in October 2007 and aimed at improving knowledge on the safety and appropriateness of somatropin
Danish: Denne undersøgelse (”Santé Adulte GH Enfant” (SAGhE)undersøgelsen) blev påbegyndt i oktober 2007.
English: An analysis in approximately 7,000 of those patients who were treated for growth hormone deficiency and for gestational or idiopathic short stature showed a possible increased risk of mortality with somatropin compared with the general population.
Danish: Ca. 7 000 af disse patienter blev behandlet for væksthormonmangel samt for lav højde, der var graviditetsbetinget eller havde ukendt årsag.
English: 3 ml (3.5mg/ml) 1 pre-filled pen
Danish: 3 ml (3,5mg/ml) 1 fyldt pen
English: It must not be given to pregnant women.
Danish: Det må ikke gives til gravide kvinder.
English: The treatment is continued until the patient no longer benefits from it.
Danish: Behandlingen fortsættes, indtil patienten ikke længere har fordel af den.
English: The first infusion of Mvasi should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion is tolerated well.
Danish: Den første infusion af Mvasi bør vare 90 minutter, men de efterfølgende infusioner kan gives hurtigere, hvis den første infusion blev tolereret godt.
English: The full EPAR for Mvasi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Mvasi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated and the other cancer medicines being used.
Danish: Dosis er mellem 5 og 15 mg pr. kilo legemsvægt hver anden eller tredje uge afhængigt af, hvilken type kræft der behandles og hvilke andre lægemidler der anvendes.
English: This is a summary of the European public assessment report (EPAR) for Mvasi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Mvasi.
English: The cancer responded to treatment in 39% of those given Mvasi (128 of 328 patients) and 42% of those given Avastin (131 of 314).
Danish: Behandlingen virkede på kræften hos 39 % af de patienter, der fik Mvasi (128 ud af 328 patienter), og hos 42 % af dem, der fik Avastin (131 ud af 314 patienter).
English: Other information about Mvasi
Danish: Andre oplysninger om Mvasi
English: This means that Mvasi is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Mvasi er identisk med et biologisk lægemiddel (også kaldet "referencelægemidlet"), der allerede er godkendt i Den Europæiske Union (EU).
English: The doctor may decide to interrupt or stop treatment if the patient develops certain side effects.
Danish: Lægen kan beslutte at afbryde eller helt stoppe behandlingen, hvis patienten oplever bestemte bivirkninger.
English: What measures are being taken to ensure the safe and effective use of Mvasi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mvasi?
English: The reference medicine for Mvasi is Avastin.
Danish: Referencelægemidlet for Mvasi er Avastin.
English: Therefore, the Agency's view was that, as for Avastin, the benefit outweighs the identified risk.
Danish: Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Avastin.
English: In addition, a study involving 642 patients with advanced non-small cell lung cancer showed that Mvasi was as effective as Avastin when given with the cancer medicines carboplatin and paclitaxel.
Danish: Derudover har en undersøgelse af 642 patienter med fremskreden ikke-småcellet lungekræft vist, at Mvasi er lige så effektivt som Avastin, når det gives sammen med kræftmidlerne carboplatin og paclitaxel.
English: Why is Mvasi approved?
Danish: Hvorfor blev Mvasi godkendt?
English: Because Mvasi is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Mvasi.
Danish: Da Mvasi er et biosimilært lægemiddel, behøver de undersøgelser af virkning og sikkerhed, der er udført for Avastin, ikke alle gentages for Mvasi.
English: It is not intended to provide practical advice on how to use Mvasi.
Danish: Det er ikke en praktisk vejledning i, hvordan Mvasi bør anvendes.
English: What is Mvasi and what is it used for?
Danish: Hvad er Mvasi, og hvad anvendes det til?
English: What are the risks associated with Mvasi?
Danish: Hvilke risici er der forbundet med Mvasi?
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Mvasi has been shown to have a comparable quality, safety and effectiveness to Avastin.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Mvasi har samme kvalitet, sikkerhed og virkning som Avastin.
English: Mvasi contains the active substance bevacizumab and is a ‘biosimilar medicine'.
Danish: Mvasi indeholder det aktive stof bevacizumab og er et "biosimilært" lægemiddel.
English: Mvasi is used in combination with other cancer medicines, depending on the nature of any previous treatments or the presence of mutations (genetic changes) in the cancer that affect its sensitivity to particular medicines.
Danish: Mvasi bruges i kombination med andre lægemidler, afhængigt af karakteren af tidligere behandlinger eller tilstedeværelsen af mutationer (genetiske forandringer) i kræften, der påvirker dens følsomhed over for særlige lægemidler.
English: As a result, the cancer cannot develop its own blood supply and cancer cells are starved of oxygen and nutrients, helping to slow down the growth of tumours.
Danish: Dette bevirker, at kræften ikke kan udvikle sin egen blodforsyning og derfor får mindre ilt og færre næringsstoffer, hvilket er med til at hæmme væksten af tumorer.
English: The Agency recommended that Mvasi be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Mvasi.
English: The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain.
Danish: De hyppigste bivirkninger ved bevacizumab (som kan forekomme hos mere end 1 ud af 10 personer) er forhøjet blodtryk, træthed eller svaghed, diarré og mavesmerter.
English: Mvasi can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.
Danish: Mvasi udleveres kun efter recept, og behandlingen bør overvåges af en læge med erfaring i brug af kræftlægemidler.
English: Mvasi is a cancer medicine that is used to treat adults with the following cancers:
Danish: Mvasi er et lægemiddel til behandling af voksne med følgende typer kræft:
English: For more information about treatment with Mvasi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Mvasi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Laboratory studies comparing Mvasi with Avastin have shown that the active substance in Mvasi is highly similar to that in Avastin in terms of structure, purity and biological activity.
Danish: Laboratorieundersøgelser, der sammenligner Mvasi med Avastin, har vist, at det aktive stof i Mvasi i meget høj grad svarer til Avastin, hvad angår struktur, renhed og biologisk aktivitet.
English: • breast cancer that has spread to other parts of the body;
Danish: • brystkræft, der har spredt sig til andre dele af kroppen
English: The active substance in Mvasi, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow.
Danish: Det aktive stof i Mvasi, bevacizumab, er et protein af typen monoklonalt antistof, der er designet til at genkende og binde til proteinet vaskulær endotelial vækstfaktor (VEGF), som cirkulerer i blodet og får blodkar til at vokse.
English: Mvasi can be used in non-small cell lung cancer unless it orginates in cells of a particular type (called squamous cells);
Danish: Mvasi kan bruges mod ikke-småcellet lungekræft, medmindre kræften stammer fra en bestemt type celler (pladeepitelceller)
English: Mvasi must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant antibodies.
Danish: Mvasi må ikke anvendes af personer, der er allergiske over for bevacizumab eller andre af indholdsstofferne eller over for lægemidler med ovarieceller fra kinesiske hamstre eller andre rekombinante antistoffer.
English: • a type of lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery, including cases where the cancer cells have a mutation
Danish: • en type lungekræft (ikke-småcellet lungekræft), der er fremskreden, har spredt sig eller vender tilbage, og som ikke kan behandles med kirurgi, herunder tilfælde, hvor kræftcellerne har en mutation (forandring) i genet i et protein, der hedder EGFR.
English: • cancer of the ovary or associated structures (the fallopian tube that carries the egg from the ovary to the womb or the peritoneum, the membrane that lines the abdomen);
Danish: • kræft i æggestokkene eller relaterede strukturer (æggelederen, der fører æggene fra æggestokken til livmoderen, eller bughinden, der beklæder bugvæggens inderside)
English: Studies have also shown that giving Mvasi produces similar levels of the active substance in the body to giving Avastin.
Danish: Der er også udført undersøgelser, der påviser, at behandling med Mvasi frembringer samme mængde aktivt stof i kroppen som behandling med Avastin.
English: For practical information about using Mvasi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Mvasi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries).
Danish: De mest alvorlige bivirkninger er huller i tarmvæggen, blødning og blodpropper i arterierne.
English: What benefits of Mvasi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Mvasi?
English: For the full list of all side effects reported with Mvasi, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Mvasi fremgår af indlægssedlen.
English: • cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;
Danish: • nyrekræft (nyrecellekarcinom), der er fremskreden, eller som har spredt sig
English: By attaching to VEGF, Mvasi stops it having an effect.
Danish: VEGF's effekt standses, når Mvasi binder sig til VEGF.
English: How is Mvasi used?
Danish: Hvordan anvendes Mvasi?
English: How does Mvasi work?
Danish: Hvordan virker Mvasi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mvasi have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Mvasi.
English: Mvasi is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Danish: Mvasi leveres som et koncentrat, der opblandes til en opløsning, som indgives via drop i en blodåre.
English: • cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or spread to other parts of the body.
Danish: • livmoderhalskræft, der er vedvarende eller vender tilbage efter behandling, eller som har spredt sig til andre dele af kroppen.
English: • cancer of the colon (large bowel) or the rectum, when it has spread to other parts of the body;
Danish: • kræft i tyktarmen eller endetarmen, som har spredt sig til andre dele af kroppen
English: This summary was last updated in 01-2017.
Danish: Dette sammendrag blev sidst ajourført i 01-2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tivicay on 16 January 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tivicay den 16. januar 2014.
English: This is a summary of the European public assessment report (EPAR) for Tivicay.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tivicay.
English: The full EPAR and risk management plan summary for Tivicay can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Tivicay findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tivicay is available as tablets (10, 25 and 50 mg).
Danish: Tivicay fås som tabletter (10 mg, 25 mg og 50 mg).
English: Two studies involved patients who had not previously been treated for HIV:
Danish: To undersøgelser omfattede patienter, der ikke tidligere var blevet behandlet for hiv:
English: Tivicay was demonstrated to be effective against HIV-1 in four main studies in adults.
Danish: Tivicay blev påvist at være effektivt mod hiv-1 i fire hovedundersøgelser omfattende voksne patienter.
English: Other information about Tivicay
Danish: Andre oplysninger om Tivicay
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tivicay'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) konkluderede, at fordelene ved Tivicay opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The medicine was generally well tolerated, although the CHMP noted the possible risk of infrequent but severe hypersensitivity reactions.
Danish: Lægemidlet var sædvanligvis veltolereret, skønt CHMP bemærkede den mulige risiko for ikke almindelige, men svære overfølsomhedsreaktioner.
English: In addition, the dose of Tivicay may need to be adjusted if certain medicines are taken at the same time.
Danish: Desuden kan det være nødvendigt at tilpasse dosis af Tivicay ved samtidig anvendelse af visse lægemidler.
English: What measures are being taken to ensure the safe and effective use of Tivicay?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tivicay?
English: The most common side effects with Tivicay (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea, and headache.
Danish: De hyppigste bivirkninger ved Tivicay (som optræder hos mere end 1 ud af 10 personer) er kvalme, diarré og hovedpine.
English: This is an antiviral medicine that blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
Danish: Dette antivirale lægemiddel blokerer enzymet integrase, som hivvirus behøver for at danne nye kopier af sig selv i kroppen.
English: Tivicay does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Tivicay helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: More serious adverse effects that have been reported include an uncommon but severe hypersensitivity (allergic) reaction with rash and possible effects on the liver.
Danish: Til de mere alvorlige bivirkninger hører en ikke almindelig, men svær overfølsomhedsreaktion (allergisk reaktion) med udslæt og mulig påvirkning af leveren.
English: It is used together with other medicines to treat adults and children from 6 years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Det anvendes sammen med andre lægemidler til behandling af voksne og af børn fra 6-årsalderen, som er smittet med humant immundefektvirus type 1 (hiv-1).
English: Patients were treated with a combination of HIV medicines that included either Tivicay or raltegravir.
Danish: Patienterne blev behandlet med en kombination af hivlægemidler, der omfattede enten Tivicay eller raltegravir.
English: The adult dose depends on whether the infection is known or suspected to be resistant to medicines of the class to which Tivicay belongs (integrase inhibitors).
Danish: Dosis til voksne afhænger af, om infektionen vides eller antages at være resistent mod lægemidler af den klasse, som Tivicay tilhører (integrasehæmmere).
English: Tivicay is an antiviral medicine containing the active substance dolutegravir.
Danish: Tivicay er et antiviralt lægemiddel, der indeholder det aktive stof dolutegravir.
English: Tivicay must not be given together with dofetilide, a medicine for disturbances of heart rhythm, as it may cause serious side effects.
Danish: Tivicay må ikke gives sammen med dofetilid, et lægemiddel mod forstyrrelser i hjerterytmen, da dette kan medføre svære bivirkninger.