FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measures of effectiveness were the number of patients who responded to treatment, and how long it took before treatment stopped working, during the first 48 weeks of treatment.
Danish: Det primære effektmål var antallet af patienter, som responderede på behandlingen, og den tid, der gik, inden behandlingen ophørte med at virke inden for de første 48 timer af behandlingen.
English: All of the patients started treatment with the oral solution, but adolescents taking the full adult dose could switch to the capsules after four weeks.
Danish: Alle patienter begyndte behandlingen med den orale opløsning, mens unge, som tog den fulde voksendosis, kunne skifte til kapsler efter fire uger.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aptivus.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Aptivus skal anvendes.
English: A ‘response' was defined as a fall in the levels of HIV in the blood (viral load) by 90% or more that was maintained until the end of the 48 weeks.
Danish: »Respons« blev defineret som et fald i hiv-niveauet i blodet (viral belastning) på 90 % eller derover, som varede ved indtil udgangen af de 48 uger.
English: • medicines that are broken down in the same way as Aptivus or ritonavir and are harmful at high levels in the blood.
Danish: • lægemidler, der nedbrydes på samme måde som Aptivus eller ritonavir, og som er skadelige ved høje niveauer i blodet.
English: What measures are being taken to ensure the safe and effective use of Aptivus?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aptivus?
English: The CHMP noted that the studies supported the use of Aptivus capsules in adults.
Danish: CHMP bemærkede, at undersøgelserne underbyggede anvendelsen af Aptivus-kapsler til voksne.
English: For more information about treatment with Aptivus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Aptivus, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Aptivus is a medicine that contains the active substance tipranavir.
Danish: Aptivus er et lægemiddel, der indeholder det aktive stof tipranavir.
English: Similar side effects were seen in children and adolescents, although vomiting, rash and pyrexia (fever) were seen more commonly than in adults.
Danish: Lignende bivirkninger sås hos børn og unge, selv om opkastning, udslæt og pyreksi (feber) forekom hyppigere end hos voksne.
English: This allows a lower dose of tipranavir to be used for the same antiviral effect.
Danish: Dette gør det muligt at anvende en mindre dosis tipranavir og samtidig opnå den samme antivirale virkning.
English: Aptivus has also been studied in one study involving 63 children aged between two and 12 years, and 52 adolescents aged between 12 and 18 years, almost all of whom had taken HIV treatments in the past.
Danish: Aptivus var også genstand for en undersøgelse hos 63 børn i alderen to til 12 år og 52 unge i alderen 12 til 18 år, hvoraf næsten alle tidligere havde fået hiv-behandlinger.
English: In the study of children and adolescents, 31% of the adolescents taking the capsules (9 out of 29) and 50% of the children taking the oral solution (31 out of 62) had reached and maintained viral loads below 400 copies/ml after 48 weeks.
Danish: I undersøgelsen af børn og unge havde 31 % af de unge, der tog kapsler (9 ud af 29), og 50 % af de børn, der tog den orale opløsning (31 ud af 62), opnået og opretholdt virale belastninger på under 400 kopier/ml efter 48 uger.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Danish: Når enzymet blokeres, kan virusset ikke formere sig på normal vis, og infektionen breder sig derfor langsommere.
English: Other information about Aptivus:
Danish: Andre oplysninger om Aptivus
English: Ritonavir is another protease inhibitor that is used as a ‘booster'.
Danish: Ritonavir er en anden proteasehæmmer, der bruges som »booster«.
English: Aptivus, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Aptivus, taget i kombination med andre hiv-lægemidler, nedsætter mængden af hiv i blodet og holder den på et lavt niveau.
English: This was compared with an average of zero days in those taking the comparator, meaning that most of the patients taking the comparator did not respond to their treatment at all.
Danish: Dette blev sammenlignet med et gennemsnit på 0 dage hos dem, der tog sammenligningspræparatet, hvilket betød, at sammenligningspræparatet overhovedet ikke virkede på de fleste af de patienter, der tog det.
English: Treatment with Aptivus should be started by a doctor who has experience in the treatment of HIV-1 infection.
Danish: Behandling med Aptivus bør kun indledes af læger med erfaring i behandling af hiv-1-infektion.
English: On average, it took 113 days for treatment to stop working in adults taking Aptivus.
Danish: Der gik i gennemsnit 113 dage, inden behandlingen ikke længere virkede hos voksne, der tog Aptivus.
English: The Committee recommended that Aptivus be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Aptivus.
English: In all three studies, the patients also took ritonavir and a combination of other HIV-medicines that were chosen as they had the best chances of reducing the levels of HIV in their blood.
Danish: I alle tre undersøgelser tog patienterne også ritonavir og en kombination af andre hiv-lægemidler, som blev valgt, fordi de gav de bedste muligheder for at mindske hiv-niveauet i deres blod.
English: It slows down the rate at which tipranavir is broken down, increasing the levels of tipranavir in the blood.
Danish: Det nedsætter den hastighed, hvormed tipranavir nedbrydes, og øger derved niveauet af tipranavir i blodet.
English: The study looked at the safety and effectiveness of Aptivus, and at the levels of the medicine in the patients' blood.
Danish: I undersøgelsen så man på Aptivus' sikkerhed og effekt og niveauet af lægemidlet i patientens blod.
English: However, it concluded that the medicine should only be considered for use as ‘last line' therapy, when no other protease inhibitors are predicted to work.
Danish: Udvalget konkluderede imidlertid, at lægemidlet kun bør overvejes anvendt som »sidstevalgsbehandling«, når ingen andre proteasehæmmere forventes at virke.
English: The active substance in Aptivus, tipranavir, is a protease inhibitor.
Danish: Det aktive stof i Aptivus, tipranavir, er en proteasehæmmer.
English: It is used in patients who have already been treated with other antiviral medicines for HIV infection, and in whom many other medicines in the same class as Aptivus (protease inhibitors) do not work.
Danish: Det anvendes til patienter, der tidligere har fået antivirale lægemidler for deres hiv-infektion, og hos hvem mange lægemidler i samme klasse som Aptivus (proteasehæmmere) ikke virker.
English: Both studies compared the effects of Aptivus with those of another protease inhibitor that was chosen on the basis of the patient's previous treatments and predicted response.
Danish: I begge undersøgelser sammenlignedes virkningen af Aptivus med virkningen af en anden proteasehæmmer, der var valgt på basis af patientens tidligere behandlinger og forventede respons.
English: In the two adult studies taken together, 34% of the patients taking Aptivus (251 out of 746) responded to treatment, compared with 16% of the patients taking the comparator protease inhibitors (113 out of 737).
Danish: Når de to voksenundersøgelser blev vurderet under ét, virkede behandlingen hos 34 % af de patienter, der tog Aptivus (251 ud af 746), sammenlignet med 16 % af de patienter, der tog den proteasehæmmer, som blev brugt til sammenligning (113 ud af 737).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aptivus, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Aptivus, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Aptivus capsules have been studied in two main studies involving a total of 1,483 adults who had received many different HIV-medicines in the past, and were not responding to their current treatment combination including a protease inhibitor.
Danish: Aptivus-kapsler er blevet undersøgt i to hovedundersøgelser af i alt 1 483 voksne, der tidligere havde fået mange forskellige hiv-lægemidler, og som ikke reagerede på deres aktuelle kombinationsbehandling, der omfattede en proteasehæmmer.
English: Aptivus is used to treat patients aged two years and above who have human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Aptivus anvendes til behandling af patienter fra toårsalderen, der er smittet med humant immundefektvirus type 1 (hiv-1), som er et virus, der forårsager erhvervet immundefekt syndrom (aids).
English: In patients aged 12 years and above, the recommended dose of Aptivus is 500 mg (two capsules) twice a day.
Danish: Den anbefalede dosis Aptivus til patienter fra 12 år og derover er 500 mg (to kapsler) to gange dagligt.
English: Aptivus capsules, taken in combination with ritonavir, were more effective than the comparator medicines in patients with few remaining options for successful HIV treatment.
Danish: Aptivus-kapsler, taget i kombination med ritonavir, var mere effektivt end de lægemidler, det blev sammenlignet med, hos patienter med få resterende muligheder for vellykket hiv-behandling.
English: The Committee also decided that the benefits of Aptivus oral solution are greater than its risks for children from two to 12 years of age.
Danish: Udvalget besluttede også, at fordelene ved Aptivus i oral opløsning er større end risiciene hos børn i alderen to til 12 år.
English: However, the available information does not support the use of the oral solution in patients aged 12 years or above.
Danish: Der var imidlertid ikke tilstrækkelig information til at underbygge anvendelsen af den orale opløsning til patienter på 12 år og derover.
English: In adults, the most common side effects when taking Aptivus with ritonavir (seen in more than 1 patient in 10) are diarrhoea and nausea (feeling sick).
Danish: De hyppigste bivirkninger hos voksne, når Aptivus tages sammen med ritovanir, (som optræder hos flere end 1 ud af 10 patienter) er diarré og kvalme.
English: Each dose of Aptivus must be taken with ritonavir and food.
Danish: Hver dosis Aptivus skal tages sammen med ritonavir og i forbindelse med et måltid.
English: Aptivus with ritonavir must not be used in patients with moderate or severe problems with their liver or who are taking any of the following medicines:
Danish: Aptivus i kombination med ritonavir må ikke anvendes til patienter med moderate til svære leverproblemer eller til patienter, der tager ét eller flere af følgende lægemidler:
English: What is the risk associated with Aptivus?
Danish: Hvilken risiko er der forbundet med Aptivus?
English: Aptivus is used in combination with low-dose ritonavir (another HIV-medicine) and other HIV-medicines.
Danish: Aptivus anvendes i kombination med lave doser af ritonavir (et hiv-lægemiddel) og andre hivlægemidler.
English: Doctors should only prescribe Aptivus once they have looked at the HIV-medicines that the patient has taken before and the likelihood that the virus will respond to the medicine.
Danish: Lægen bør inden ordinering af Aptivus først undersøge, hvilket hiv-lægemiddel patienten tidligere har fået, samt vurdere, om det er sandsynligt, at virusset vil reagere på lægemidlet.
English: For the full list of all side effects reported with Aptivus, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Aptivus fremgår af indlægssedlen.
English: Aptivus with ritonavir must not be used with colchicine (a medicine used to treat gout) in patients with kidney or liver impairment.
Danish: Aptivus i kombination med ritonavir må ikke anvendes sammen med colchicin (et lægemiddel til behandling af urinsyregigt) hos patienter med nedsat nyre- eller leverfunktion.
English: Although the Committee had some concerns over how the study in children and adolescents was designed, the Committee noted that its results supported the use of the capsules in adolescents and the oral solution in children between the ages of two and 12 years.
Danish: Selv om udvalget var noget betænkelig ved den måde, undersøgelsen af børn og unge var udformet på, bemærkede udvalget, at resultaterne underbyggede anvendelsen af kapslerne til unge og den orale opløsning til børn mellem to og 12 år Udvalget konkluderede derfor, at fordelene ved Aptivus-kapsler er større end risiciene ved anvendelse til behandling af voksne og unge på 12 år eller derover.
English: Why has Aptivus been approved?
Danish: Hvorfor blev Aptivus godkendt?
English: What is Aptivus?
Danish: Hvad er Aptivus?
English: How has Aptivus been studied?
Danish: Hvordan blev Aptivus undersøgt?
English: What benefit has Aptivus shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Aptivus?
English: What is Aptivus used for?
Danish: Hvad anvendes Aptivus til?
English: How is Aptivus used?
Danish: Hvordan anvendes Aptivus?
English: This means that it was intended to be similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det vil sige, at det var hensigten, at det skulle svare til et biologisk lægemiddel ("referencelægemidlet"), som allerede er godkendt i Den Europæiske Union (EU).
English: EMA/CHMP/800910/2012 EMEA/H/C/002610
Danish: EMEA/H/C/002610
English: 13 December 2012
Danish: Den 13. december 2012 EMA/130410/2013
English: The application was a joint application from Marvel LifeSciences for Isomarv medium and two other medicines (Solumarv and Combimarv, also developed as biosimilar medicines).
Danish: Ansøgningen var en fælles ansøgning fra Marvel LifeSciences for Isomarv medium og to andre lægemidler (Solumarv og Combimarv, der ligeledes er udviklet som biosimilære lægemidler).
English: After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Isomarv medium could not have been approved.
Danish: Efter den indledende vurdering havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Isomarv medium ikke kunne godkendes.
English: On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Isomarv medium, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Danish: Den 15. november 2012 meddelte Marvel LifeSciences Ltd officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Isomarv medium til behandling af patienter med sukkersyge, som behøver insulin til regulering af blodsukkeret.
English: Isomarv medium was developed as a biosimilar medicine.
Danish: Isomarv medium blev udviklet som et biosimilært lægemiddel.
English: The insulin in Isomarv medium is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Danish: Insulinet i Isomarv medium fremstilles ved "rekombinant DNA-teknologi": Det produceres af en bakterie, der har fået indsat et gen (DNA), som gør den i stand til at producere insulin.
English: The company informed the CHMP that at the time of the withdrawal no patients were receiving Isomarv medium in clinical trials.
Danish: Virksomheden har til CHMP oplyst, at der på tilbagetrækningstidspunktet ikke var patienter, som blev behandlet med Isomarv medium i kliniske undersøgelser.
English: The initial concerns related mainly to the manufacture of the medicine and whether Isomarv medium was sufficiently similar to its reference medicine.
Danish: De indledende betænkeligheder vedrørte hovedsagelig fremstillingen af lægemidlet, og hvorvidt Isomarv medium tilstrækkeligt svarede til referencelægemidlet.
English: Among these were results from studies that looked at how the body handles Isomarv medium compared with Humulin I and how these insulins affect blood sugar levels.
Danish: Der var blandt andet tale om undersøgelser af, hvordan kroppen håndterer Isomarv medium sammenlignet med Humulin I, og hvordan disse insuliner påvirker blodsukkeret.
English: The company presented the results of studies designed to show that Isomarv medium is similar to its reference medicine Humulin I in terms of its structure, biological activity and clinical performance.
Danish: Virksomheden fremlagde resultaterne af undersøgelser, der skulle vise, at Isomarv medium svarer til referencelægemidlet Humulin I hvad angår struktur, biologisk aktivitet og kliniske virkninger.
English: What is Isomarv medium?
Danish: Hvad er Isomarv medium?
English: Isomarv medium is a medicine that contains the active substance human insulin.
Danish: Isomarv medium er et lægemiddel, der indeholder det aktive stof insulin, humant.
English: What was Isomarv medium expected to be used for?
Danish: Hvad forventedes Isomarv medium anvendt til?
English: Isomarv medium was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Danish: Isomarv medium forventedes anvendt til behandling af patienter med sukkersyge, som behøver insulin til regulering af blodsukkeret.
English: Isomarv medium was intended as a replacement insulin that is similar to the insulin made by the body.
Danish: Det var hensigten, at Isomarv medium skulle være et erstatningsinsulin, der stærkt ligner det insulin, som kroppen producerer.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Isomarv medium?
English: How is Isomarv medium expected to work?
Danish: Hvordan forventes Isomarv medium at virke?
English: The reference medicine for Isomarv medium in this application was Humulin I. For more information on biosimilar medicines, see the questions-and-answers document here.
Danish: Referencelægemidlet for Isomarv medium i denne ansøgning var Humulin I.
English: Co. Galway IRELAND
Danish: Co. Galway IRLAND
English: System Organ Class Frequency Preferred Terma
Danish: Systemorganklasse Hyppighed Foretrukken Terma
English: Adult females (including elderly)
Danish: Voksne kvinder (inklusive ældre)
English: Fulvestrant is indicated:
Danish: Fulvestrant er indiceret:
English: Number of patients at risk FUL500 230
Danish: Antal patienter i risiko FUL500 230
English: % of patients with CB; absolute difference in
Danish: % patienter med CB; absolut forskel i %
English: *(31% maturity)-not final OS analysis **for patients with measurable disease
Danish: *(31% modenhed) - ikke endelig OS-analyse **for patienter med målbar sygdom
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1253/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1253/001
English: OS is presented for the final survival analyses at 75 % maturity.
Danish: OS vises for de endelige overlevelsesanalyser ved 75% modenhed.
English: Seventy seven percent (77%) of the study population had estrogen receptor positive breast cancer.
Danish: Syvoghalvfjerds procent (77%) af studiepopulationen havde østrogen receptor positiv brystkræft.
English: Elevated bilirubina
Danish: Forhøjet bilirubina
English: Fulvestrant is not indicated for use in children.
Danish: Fulvestrant er ikke indiceret til brug hos børn.
English: You must not use Fulvestrant Mylan if you are pregnant.
Danish: Du må ikke anvende Fulvestrant Mylan, hvis du er gravid.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 january 2018
Danish: Dato for første markedsføringstilladelse: 8. januar 2018
English: Your healthcare professional will be responsible for the correct storage, use and disposal of Fulvestrant Mylan.
Danish: Personalet har ansvaret for den korrekte opbevaring, anvendelse og bortskaffelse af Fulvestrant Mylan.
English: Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.
Danish: På grund af fulvestrants virkningsmekanisme er der en potentiel risiko for osteoporose.
English: Pharmacotherapeutic group: Endocrine therapy, anti-estrogens, ATC code: L02BA03
Danish: Farmakoterapeutisk klassifikation: Endokrin behandling, anti-estrogener, ATC-kode: L02BA03
English: The terminal half-life (t1/2) after intramuscular administration is governed by the absorption rate and was estimated to be 50 days.
Danish: Den terminale halveringstid (t1/2) efter intramuskulær administration er bestemt af absorptionshastigheden og blev estimeret til at være 50 dage.
English: % of patients with OR absolute difference in %
Danish: % af patienter med OR absolut forskel i % Alle patienter
English: Children and adolescents Fulvestrant Mylan is not indicated in children and adolescents under 18 years.
Danish: Børn og unge Fulvestrant Mylan er ikke beregnet til børn og unge under 18 år.
English: The median time to death was 27.4 months for patients treated with fulvestrant and 27.6 months for patients treated with anastrozole.
Danish: Den gennemsnitlige tid til død var 27,4 måneder for patienter i behandling med fulvestrant og 27,6 måneder for patienter i behandling med anastrozol.
English: In patients administered fulvestrant, an increase in exposure of this magnitude is expected to be well tolerated.
Danish: Hos patienter, der får fulvestrant, forventes en stigning i eksponering af denne størrelse at være veltolereret.
English: Nominal p-value with no adjustments made for multiplicity between the initial overall survival analyses at 50% maturity and the updated survival analyses at 75% maturity.
Danish: Nominel p-værdi uden foretagne justeringer for multiplicitet mellem de indledende samlede overlevelsesanalyser ved 50% modenhed og de opdaterede overlevelsesanalyser ved 75% modenhed.
English: There are isolated reports of overdose with fulvestrant in humans.
Danish: Der findes enkeltstående rapporter om overdosering med fulvestrant hos mennesker.
English: Identified metabolites (includes 17-ketone, sulphone, 3-sulphate, 3- and 17-glucuronide metabolites) are either less active or exhibit similar activity to fulvestrant in anti-estrogen models.
Danish: Identificerede metabolitter (inkluderer 17-keton, sulfon, 3 sulfat 3- og 17-glucoronid metabolitter) er enten mindre aktive eller viser tilsvarende aktivitet som fulvestrant i antiøstrogene modeller.
English: At steady state, fulvestrant plasma concentrations are maintained within a relatively narrow range with up to an approximately 3-fold difference between maximum and trough concentrations.
Danish: Ved steady state er fulvestrant plasmakoncentrationer bibeholdt inden for et relativt smalt koncentrationsområde med op til cirka 3 foldig difference mellem maksimale og dalkoncentrationer.
English: Fulvestrant is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see section 5.1).
Danish: Fulvetrant anbefales ikke til børn og unge, da sikkerheden og virkningen ikke er klarlagt hos denne patientgruppe (se pkt.