FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is one tablet per day, and the strength of Descovy tablet chosen by the doctor depends on which other medicines it is given with.
Danish: Lægen vælger styrken af Descovytabletten ud fra, hvilke andre lægemidler den gives sammen med.
English: Similarly to Genvoya, Descovy offers an alternative option to giving emtricitabine with tenofovir disoproxil
Danish: Ligesom Genvoya giver Descovy mulighed for, at emtricitabin kan gives sammen med tenofovirdisoproxil.
English: How does Descovy work?
Danish: Hvordan virker Descovy?
English: How is Descovy used?
Danish: Hvordan anvendes Descovy?
English: This summary was last updated in 04-2016.
Danish: Descovy EMA/169100/2016
English: This summary was last updated in 02-2010.
Danish: Dette sammendrag blev sidst ajourført i 02-2010.
English: This includes adults (aged 18 years and older) who are also infected with human immunodeficiency virus (HIV).
Danish: Dette omfatter voksne (i alderen 18 år og derover), som også er smittet med humant immundefekt virus (hiv).
English: The duration of treatment depends on the patient's condition and response to treatment, and ranges from six months to a year.
Danish: Behandlingens varighed afhænger af patientens tilstand og reaktion på behandlingen og er mellem seks måneder og ét år.
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 Ribavirin BioPartners.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Ribavirin BioPartners.
English: Ribavirin BioPartners must never be used on its own but only together with peginterferon alfa 2b or interferon alfa 2b (other medicines used in
Danish: Ribavirin BioPartners må aldrig anvendes alene, men kun sammen med peginterferon alfa 2b eller interferon alfa 2b (andre lægemidler mod
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ribavirin BioPartners to BioPartners GmbH on 6 April 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ribavirin BioPartners til BioPartners GmbH den 6. april 2010.
English: This document is a summary of the European Public Assessment Report (EPAR) for Ribavirin BioPartners.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ribavirin BioPartners.
English: Ribavirin BioPartners can also be used in adults whose disease has come back after previous treatment or whose previous treatment
Danish: Ribavirin BioPartners kan også anvendes hos voksne, hvor sygdommen er kommet tilbage efter tidligere behandling, eller hvor den
English: The CHMP concluded that, in accordance with EU requirements, Ribavirin BioPartners has been shown to have comparable quality and to be bioequivalent to Rebetol.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Ribavirin BioPartners er af sammenlignelig kvalitet og er bioækvivalent med Rebetol.
English: This means that Ribavirin BioPartners is similar to a ‘reference medicine' already authorised in the European Union (EU) called Rebetol.
Danish: Det betyder, at Ribavirin BioPartners er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Rebetol.
English: Ribavirin BioPartners is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
Danish: Ribavirin BioPartners menes at gribe ind i produktionen eller virkningen af viralt DNA og RNA, som er nødvendige for virussets overlevelse og formering.
English: Ribavirin BioPartners is used in patients who have not been treated before, as long as the liver is still working and hepatitis C virus can be found in the blood.
Danish: Ribavirin BioPartners anvendes til patienter, som aldrig har været behandlet før, så længe leveren stadig fungerer, og der forekommer hepatitis C virus i blodet.
English: Ribavirin BioPartners is a ‘generic medicine'.
Danish: Ribavirin BioPartners er et ‘generisk lægemiddel'.
English: For more information about treatment with Ribavirin BioPartners, read the Package Leaflet (also part of the EPAR).
Danish: De nærmere oplysninger om behandling med Ribavirin BioPartners fremgår af indlægssedlen (også en del af EPAR).
English: Other information about Ribavirin BioPartners:
Danish: Andre oplysninger om Ribavirin BioPartners:
English: Treatment with Ribavirin BioPartners should be started and monitored by a doctor who has experience in the management of long-term hepatitis C. The dose of Ribavirin BioPartners is based on the patient's body weight, and ranges from three to seven tablets a day.
Danish: Behandlingen med Ribavirin BioPartners bør iværksættes og overvåges af en læge med erfaring i behandling af patienter med langvarig hepatitis C. Dosis af Ribavirin BioPartners beregnes efter patientens legemsvægt og er mellem tre og syv kapsler dagligt.
English: The full EPAR for Ribavirin BioPartners can be found here.
Danish: Den fuldstændige EPAR for Ribavirin BioPartners findes her.
English: The Committee recommended that Ribavirin BioPartners be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Ribavirin BioPartners.
English: Ribavirin BioPartners on its own has no effect on eliminating the hepatitis C virus from the body.
Danish: Anvendt alene er Ribavirin BioPartners uden virkning med hensyn til at udrydde hepatitis C-virus i kroppen.
English: Ribavirin BioPartners is a medicine that contains the active substance ribavirin.
Danish: Ribavirin BioPartners er et lægemiddel, der indeholder det aktive stof ribavirin.
English: Because Ribavirin BioPartners is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Rebetol.
Danish: Da Ribavirin BioPartners er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Rebetol.
English: Because Ribavirin BioPartners is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Danish: Da Ribavirin Biopartners er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The active substance in Ribavirin BioPartners, ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'.
Danish: Det aktive stof i Ribavirin BioPartners, ribavirin, er et antiviralt middel, der tilhører gruppen af nukleosidanaloger.
English: What are the benefit and risk of Ribavirin BioPartners?
Danish: Hvilken fordel og risiko er der forbundet med Ribavirin BioPartners?
English: It is available as round,
Danish: Det fås som hvide,
English: Ribavirin BioPartners is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Danish: Ribavirin BioPartners anvendes til behandling af patienter i alderen 3 år eller ældre med langvarig hepatitis C (leverbetændelse forårsaget af hepatitis C-virus).
English: Ribavirin BioPartners is taken with food each day in two divided doses (morning and evening).
Danish: Lægemidlet kan kun tages af patienter, der vejer mindst 47 kg. Ribavirin BioPartners tages sammen med måltiderne hver dag, fordelt på to doser (morgen og aften).
English: Why has Ribavirin BioPartners been approved?
Danish: Hvorfor blev Ribavirin BioPartners godkendt?
English: How has Ribavirin BioPartners been studied?
Danish: Hvordan blev Ribavirin BioPartners undersøgt?
English: How is Ribavirin BioPartners used?
Danish: Hvordan anvendes Ribavirin BioPartners?
English: What is Ribavirin BioPartners used for?
Danish: Hvad anvendes Ribavirin BioPartners til?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ipreziv on 07 December 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ipreziv den 7. december 2011.
English: It must not be used in women who are more than three months pregnant.
Danish: Det må ikke anvendes hos kvinder, som er mere end tre måneder henne i graviditeten.
English: This is a summary of the European public assessment report (EPAR) for Ipreziv.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ipreziv.
English: The full EPAR for Ipreziv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Ipreziv findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The effects of Ipreziv were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Ipreziv blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Other information about Ipreziv
Danish: Andre oplysninger om Ipreziv:
English: Ipreziv on its own was more effective than placebo.
Danish: Ipreziv taget alene var mere virkningsfuldt end placebo.
English: It is available as tablets (20 mg, 40 and 80 mg).
Danish: Det fås som tabletter (20, 40 og 80 mg).
English: Eight main studies involving over 6,000 patients with essential hypertension were carried out with Ipreziv.
Danish: Der blev foretaget otte hovedundersøgelser med flere end 6 000 patienter med essentiel hypertension.
English: Ipreziv is taken by mouth and the usual recommended dose is 40 mg once a day.
Danish: Ipreziv tages gennem munden, og den normale anbefalede dosis er 40 mg én gang dagligt.
English: What is the risk associated with Ipreziv?
Danish: Hvilken risiko er der forbundet med Ipreziv?
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 Ipreziv.
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 anvendelsesbetingelserne for Ipreziv.
English: Ipreziv 40 and 80 mg was also more effective than ramipril (10 mg).
Danish: Ipreziv 40 og 80 mg var også mere virkningsfuldt end ramipiril (10 mg).
English: For more information about treatment with Ipreziv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ipreziv, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The studies also showed that Ipreziv, when taken in combination with other medicines, can produce additional decreases in blood pressure compared with when these medicines are taken without Ipreziv.
Danish: Undersøgelserne viste også, at Ipreziv, når det tages i kombination med andre lægemidler, kan nedsætte blodtrykket yderligere, sammenlignet med når lægemidlerne tages uden Ipreziv.
English: Side effects with Ipreziv are generally mild or moderate, with the most common side effect being dizziness.
Danish: Bivirkningerne ved Ipreziv er generelt milde eller moderate med svimmelhed som den mest almindelige bivirkning.
English: Ipreziv is a medicine that contains the active substance azilsartan medoxomil.
Danish: Ipreziv er et lægemiddel, der indeholder det aktive stof azilsartan-medoxomil.
English: Ipreziv is used in adults who have essential hypertension (high blood pressure).
Danish: Ipreziv anvendes til voksne, der har essentiel hypertension (for højt blodtryk).
English: The active substance in Ipreziv, azilsartan medoxomil, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Ipreziv, azilsartan-medoxomil, er en "angiotensin II-receptorantagonist", hvilket betyder, at det blokerer virkningen af et hormon i kroppen kaldet angiotensin II.
English: What is Ipreziv?
Danish: Hvad er Ipreziv?
English: The CHMP concluded that Ipreziv belongs to an established class of medicines in the treatment of hypertension and its risks are similar to others within this class.
Danish: CHMP konkluderede, at Ipreziv hører til en velkendt klasse af lægemidler til behandling af hypertension, og at det indebærer samme risici som andre lægemidler inden for denne klasse.
English: EPAR summary for the public azilsartan medoxomil
Danish: EPAR - sammendrag for offentligheden azilsartan-medoxomil
English: Why has Ipreziv been approved?
Danish: Hvorfor blev Ipreziv godkendt?
English: For the full list of all side effects reported with Ipreziv, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Ipreziv fremgår af indlægssedlen.
English: In the two studies with Ipreziv taken alone compared with placebo, patients had an average fall in systolic blood pressure of about 13.5 mmHg on Ipreziv 40 mg and a fall of about 14.5 mmHg on Ipreziv 80 mg after 6 weeks.
Danish: I de to undersøgelser, hvor Ipreziv taget alene blev sammenlignet med placebo, faldt patienternes systoliske blodtryk efter 6 uger med ca. 13,5 mmHg i gennemsnit for Ipreziv 40 mg og med ca. 14,5 mmHg for Ipreziv 80 mg. Til sammenligning faldt det med 0,3 til 1,4 mmHg hos patienter, der fik placebo.
English: The Committee decided that the benefits of Ipreziv are greater than its risks in patients with essential hypertension and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Ipreziv opvejer risiciene hos patienter med essentiel hypertension og anbefalede udstedelse af markedsføringstilladelse for Ipreziv.
English: Three studies investigated the effects of Ipreziv in combination with other antihypertensive medicines (chlortalidone, amlodipine, and hydrochlorothiazide).
Danish: I tre af undersøgelserne undersøgte man virkningerne af Ipreziv i kombination med andre lægemidler mod hypertension (chlortalidon, amlodipin og hydrochlorthiazid).
English: When Ipreziv alone was compared with other medicines, 80 mg of Ipreziv was more effective in lowering blood pressure than the highest approved dose of valsartan (320 mg) and olmesartan medoxomil (40 mg).
Danish: Når Ipreziv taget alene blev sammenlignet med andre lægemidler, havde 80 mg Ipreziv større blodtrykssænkende effekt end den højeste godkendte dosis valsartan (320 mg) og olmesartanmedoxomil (40 mg).
English: Five studies investigated the effects of Ipreziv taken alone, comparing it with placebo (a dummy treatment) or with other antihypertensive medicines (ramipril, valsartan and olmesartan medoxomil).
Danish: I fem af undersøgelserne blev virkningerne af Ipreziv, når det blev taget alene, sammenlignet med placebo (en virkningsløs behandling) eller med andre lægemidler mod hypertension (ramipiril, valsartan og olmesartan-medoxomil).
English: What is Ipreziv used for?
Danish: Hvad anvendes Ipreziv til?
English: Ipreziv must not be used in people who are hypersensitive (allergic) to azilsartan medoxomil or any of the other ingredients.
Danish: Ipreziv må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for azilsartanmedoxomil eller andre af indholdsstofferne.
English: How is Ipreziv used?
Danish: Hvordan anvendes Ipreziv?
English: How has Ipreziv been studied?
Danish: Hvordan blev Ipreziv undersøgt?
English: What benefit has Ipreziv shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ipreziv?
English: How does Ipreziv work?
Danish: Hvordan virker Ipreziv?
English: This will limit the risk of under-treatment of patients who would benefit from these treatments or high intensity treatment.
Danish: Dette vil begrænse risikoen for underbehandling af patienter, som ville drage fordel af disse behandlinger eller af en meget intensiv behandling.
English: The procedure was subsequently referred to the CHMP.
Danish: Proceduren blev efterfølgende indbragt for CHMP.
English: In conclusion, the CHMP adopted the following indications:
Danish: CHMP vedtog således følgende indikationer:
English: According to the Applicant, the superior efficacy was achieved with lower toxicity.
Danish: Ifølge ansøgeren blev den højere virkning opnået med en lavere toksicitet.
English: According to the CHMP anticancer guideline (CPMP/EWP/205/95/Rev.3/Corr.
Danish: Ifølge CHMP's anticancer retningslinje (CPMP/EWP/205/95/Rev.3/Corr.)
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LEVACT AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF LEVACT OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Co-primary endpoints in both trials were overall response rate and duration of response.
Danish: Co-primære effektmål i begge undersøgelser var den samlede responsrate og varigheden af responset.
English: Only the overall response rate (ORR) and the complete remission rates were superior in the BP arm.
Danish: Kun den samlede responsrate (ORR) og de fuldstændige remissionsrater var højere for BP.
English: Bendamustine has been used clinically as an antineoplastic agent in the German Democratic Republic since 1971 and there is therefore substantial clinical experience with bendamustine in Germany.
Danish: Bendamustin er blevet anvendt klinisk som et antineoplastisk middel i Den Tyske Demokratiske Republik siden 1971, og der findes derfor betydelige kliniske erfaringer med bendamustin i Tyskland.
English: During this procedure, all involved member states agreed on the CLL indication, however, no agreement was reached for the MM and NHL indications.
Danish: Under denne procedure var alle involverede medlemsstater enige i CLL-indikationen, men der blev ikke opnået enighed om MM- og NHL-indikationerne.
English: Subgroup analyses of ORR, disease rate and PFS results demonstrate overall homogeneous results.
Danish: Undergruppeanalyser af ORR, sygdomsrate og PFSresultater viser generelt homogene resultater.
English: In addition, a reduction of tumour burden of over 50% was observed in 78% of the supportive study patients, suggesting a likely clinical benefit for this population.
Danish: Derudover blev der observeret en reduktion i tumorbyrden på over 50 % hos 78 % af patienterne i den understøttende undersøgelse, hvilket tyder på en sandsynlig klinisk fordel for denne population.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: This confirms that the efficacy of bendamustine is not negated by safety concerns among frailer patients.
Danish: Dette bekræfter, at virkningen af bendamustin ikke negeres af sikkerhedshensyn blandt mere skrøbelige patienter.
English: The Applicant also provided a study report from an additional uncontrolled study performed in Japan, in which the overall results were consistent with earlier experience.
Danish: Ansøgeren fremsendte også en undersøgelsesrapport fra en supplerende ukontrolleret undersøgelse gennemført i Japan, hvor de overordnede resultater var forenelige med tidligere erfaringer.
English: Supportive evidence for the efficacy of bendamustine can also be derived from the high complete remission rate, an increasingly important endpoint in multiple myeloma.
Danish: Understøttende dokumentation for bendamustins virkning kan også udledes af den høje rate for fuldstændig remission, et stadig vigtigere effektmål ved multipelt myelom.
English: Durable responses may be linked to patient benefit by clinically relevant reduction of disease burden (greater than 50% decrease of measurable disease in 78% of patients).
Danish: Varig respons kan knyttes til patientfordele ved en klinisk relevant nedbringelse af sygdomsbyrden (mere end 50 % fald i målbar sygdom hos 78 % af patienterne).
English: The primary endpoints were time to treatment failure (TTF) and the secondary endpoints were survival time, survival rate after 2 years, rate and duration of remission, toxicity, quality of life and crossresistance.
Danish: De primære effektmål var "time to treatment failure" (TTF) og de sekundære effektmål var overlevelsestid, overlevelsesrate efter 2 år, remissionsrate og -varighed, toksicitet, livskvalitet og krydsresistens.
English: Regarding the rituximabrefractory NHL indication, the lack of controlled data is acceptable as long as the wording of the indication clearly reflects the refractory nature of the disease.
Danish: Med hensyn til indikationen rituximab refraktær NHL er mangelen på kontrollerede data acceptabel, så længe ordlyden i indikationen klart afspejler sygdommens refraktære karakter.
English: The quality of the presented trials is variable, in particular in indications for which the product is already known to the effective, such as multiple myeloma, where the design of the studies is weak in comparison to the current standards.
Danish: Kvaliteten af de fremlagte undersøgelsesresultater varierer, særlig med hensyn til de indikationer, for hvilke lægemidlet allerede vides at være virkningsfuldt, såsom multipelt myelom, hvor udformningen af undersøgelserne er svag sammenlignet med de aktuelle standarder.
English: Based on the submitted data and in view of the adequate commitments, the CHMP considered the referred indications to be approvable.
Danish: På grundlag af de forelagte oplysninger og i lyset af de tilstrækkelige forpligtelser fandt CHMP, at de fremsendte indikationer kunne godkendes.
English: While PFS would be the best primary endpoint in a randomised study, with ORR as secondary endpoint, this would require a prohibitively large number of patients for a confirmative approach.
Danish: Mens PFS ville være det bedste primære effektmål i en randomiseret undersøgelse med ORR som sekundært effektmål, ville det kræve et prohibitivt stort antal patienter at opnå en konfirmativ metode.
English: The trial included 549 patients and the ORR was similar between the two groups (93.8% vs. 93.5%).
Danish: Undersøgelsen omfattede 549 patienter, og ORR var ens for de to grupper (93,8 % mod 93,5 %).
English: ), TTF as primary endpoint does not allow the assessment of efficacy.
Danish: muliggør TTF som primært effektmål ikke en vurdering af virkningen.
English: The CR rate was significantly higher for the B-R group (40.1 vs. 30.8%), PFS was higher (54.8 vs. 34.8 months) and the Hazard Ratio (HR) was 0.5765.
Danish: CR-raten var væsentlig højere for B-R-gruppen (40,1 mod 30,8 %), PFS var højere (54,8 mod 34,8 måneder) og Hazard Ratio (HR) var 0,5765.
English: A number of concerned member states raised potential serious risks to public health with regards to the efficacy of the medicinal product in these indications, considering that non-inferiority or superior efficacy when compared to the efficacy of well established chemotherapy regimens recommended in international guideline had not been demonstrated.
Danish: En række berørte medlemsstater påpegede potentielle alvorlige risici for folkesundheden med hensyn til lægemidlets virkning ved disse indikationer, da det ikke var blevet påvist, at dets virkning ikke var dårligere eller bedre sammenlignet med effekten af veletablerede kemoterapibehandlinger anbefalet i internationale retningslinjer.
English: Efficacy of bendamustine in multiple myeloma (MM)
Danish: Bendamustins virkning ved multipelt myelom (MM)
English: In addition, the safety profile of bendamustine presented in the SPC is in line with previous experience.
Danish: Derudover er sikkerhedsprofilen for bendamustin i produktresuméet i overensstemmelse med tidligere erfaringer.