FrancophonIA/ELRC3.0 huggingface dataset:
English: Rubraca is a cancer medicine for treating high-grade cancers of the ovary, fallopian tubes (the tubes connecting ovaries to the uterus) and the peritoneum (the membrane lining the abdomen).
Danish: Rubraca er et kræftlægemiddel til behandling af malign kræft i æggestokkene, æggelederne (de rørformede kanaler, der forbinder æggestokkene med livmoderen) og bughinden (hinden, der beklæder bugvæggen).
English: How does Rubraca work?
Danish: Hvordan virker Rubraca?
English: What benefits of Rubraca have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Rubraca?
English: Rubraca has been shown to delay worsening or return of the disease in patients whose cancer had cleared partially or completely after treatment with platinum-based medicines.
Danish: Hos de patienter, hvor kræftsygdommen var delvist eller helt stoppet efter behandling med platinbaserede lægemidler, har Rubraca vist sig at udskyde forværring eller tilbagefald af sygdommen.
English: It is available as tablets (400 and 800 mg).
Danish: Det fås som tabletter (400 og 800 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Renagel on 28 January 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Renagel den 28. januar 2000.
English: The full EPAR for Renagel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Renagel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Renagel.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Renagel.
English: This leads to hyperphosphataemia, which, in the long term, can cause complications such as heart and bone disease.
Danish: Dette fører til hyperphosphatæmi, hvilket på lang sigt kan medføre komplikationer såsom hjertesygdom og knoglesygdom.
English: In the third, there was an average fall of 0.71 mmol/l over 44 weeks.
Danish: I den tredje undersøgelse var der et gennemsnitligt fald på 0,71 mmol/l over 44 uger.
English: A risk management plan has been developed to ensure that Renagel is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Renagel anvendes så sikkert som muligt.
English: Other information about Renagel
Danish: Andre oplysninger om Renagel
English: This helps to reduce the phosphate levels in the blood.
Danish: Dette bidrager til at nedsætte phosphatindholdet i blodet.
English: When taken with meals, it attaches to phosphate from food within the gut, preventing it from being absorbed into the body.
Danish: Når det tages i forbindelse med måltider, binder det sig til phosphatet i maden inde i tarmen og forhindrer, at det bliver absorberet i kroppen.
English: What measures are being taken to ensure the safe and effective use of Renagel?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Renagel?
English: The longer study looked at the use of Renagel in 192 patients, the majority of whom had taken Renagel in previous studies.
Danish: I den langvarige undersøgelse så man på brugen af Renagel hos 192 patienter, hvoraf størstedelen havde taget Renagel i tidligere undersøgelser.
English: For more information about treatment with Renagel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Renagel, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Renagel.
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 Renagel skal anvendes.
English: In all of the studies, the main measure of effectiveness was the change in blood phosphate levels between the start and the end of treatment.
Danish: I alle undersøgelserne var det vigtigste mål for virkningen ændringen i mængden af phosphat i blodet fra starten af behandlingen til afslutningen af behandlingen.
English: In haemodialysis, Renagel has been studied in two short-term studies lasting eight weeks and one longer study lasting 44 weeks.
Danish: I forbindelse med hæmodialyse er Renagel blevet undersøgt i to kortvarige undersøgelser af 8 ugers varighed og én længere undersøgelse af 44 ugers varighed.
English: Patients should take Renagel tablets whole with meals and stick to their prescribed diets.
Danish: Patienterne bør tage Renageltabletterne hele i forbindelse med måltider, og overholde deres ordinerede kostplan.
English: The recommended starting dose of Renagel depends on the level of phosphate in the blood and ranges from 800 to 1,600 mg three times a day.
Danish: Den anbefalede startdosis af Renagel afhænger af mængden af phosphat i blodet og ligger i området 800 til 1 600 mg tre gange om dagen.
English: The second, which did not compare Renagel with any other medicines, included 172 patients.
Danish: Den anden undersøgelse, som ikke sammenlignede Renagel med et andet lægemiddel, omfattede 172 patienter.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Renagel, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Renagel, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Renagel should be used with other treatments such as calcium or vitamin D supplements to control the development of bone disease.
Danish: Renagel bør anvendes sammen med andre behandlinger såsom kalcium- eller D-vitamintilskud til kontrol af udviklingen af knoglesygdom.
English: The CHMP decided that Renagel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Renagel opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Renagel.
English: Patients with long-term kidney disease cannot eliminate phosphate from their bodies.
Danish: Patienter med langvarig nyresygdom kan ikke komme af med phosphaten i kroppen.
English: Renagel sevelamer hydrochloride
Danish: Renagel sevelamerhydrochlorid
English: Renagel is a medicine that contains the active substance sevelamer hydrochloride.
Danish: Renagel er et lægemiddel, der indeholder det aktive stof sevelamerhydrochlorid.
English: The dose of Renagel should be adjusted to ensure that the blood phosphate level stays below 1.76 mmol/l.
Danish: Renageldosen bør justeres, så phosphatindholdet i blodet holdes under 1,76 mmol/l.
English: The most common side effects with Renagel (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
Danish: De hyppigste bivirkninger (som optræder hos flere end 1 ud af 10 patienter) er kvalme og opkastning.
English: The active substance in Renagel, sevelamer hydrochloride, is a phosphate binder.
Danish: Det aktive stof i Renagel, sevelamerhydrochlorid, er en phosphatbinder.
English: Renagel produced a significant decrease in serum phosphate in all of the studies.
Danish: Renagel bevirkede i alle undersøgelserne en betydelig nedsættelse af mængden af phosphat i serum.
English: What is the risk associated with Renagel?
Danish: Hvilken risiko er der forbundet med Renagel?
English: Why has Renagel been approved?
Danish: Hvorfor blev Renagel godkendt?
English: In the comparative study of patients undergoing haemodialysis, there was an average fall of 0.65 mmol/l over the eight weeks of Renagel treatment, compared with 0.68 mmol/l when the patients were taking calcium acetate.
Danish: I de sammenlignende undersøgelser med patienter, der gennemgik hæmodialyse, var der et gennemsnitligt fald på 0,65 mmol/l i løbet af Renagel-behandlingens otte uger sammenlignet med 0,68 mmol/l hos de patienter, der tog kalciumacetat.
English: It can be used in patients undergoing haemodialysis (dialysis using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Danish: Det kan anvendes til patienter, der gennemgår hæmodialyse (dialyse, hvor der anvendes et blodfiltreringsapparat) eller peritoneal dialyse (hvor der pumpes væske ind i bughulen, og en intern membran i kroppen filtrerer blodet).
English: The first study compared Renagel with calcium acetate (another phosphate-lowering medicine) in 84 patients.
Danish: Den første undersøgelse sammenlignede Renagel med kalciumacetat (et andet phosphatnedsættende lægemiddel) hos 84 patienter.
English: In peritoneal dialysis, there has been one study comparing Renagel with calcium acetate in 143 patients over 12 weeks.
Danish: I forbindelse med peritoneal dialyse blev der gennemført én undersøgelse af Renagel, der sammenlignede virkningen af Renagel med virkningen af kalciumacetat over 12 uger hos 143 patienter.
English: What is Renagel?
Danish: Hvad er Renagel?
English: Renagel is used to control hyperphosphataemia (high blood phosphate levels) in adults on dialysis (a blood clearance technique used in patients with kidney disease).
Danish: Renagel anvendes til kontrol af hyperphosphatæmi (højt phosphatindhold i blodet) hos voksne i dialyse (en blodrensningsteknik der anvendes hos patienter med nyresygdom).
English: For the full list of all side effects reported with Renagel, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Renagel fremgår af indlægssedlen.
English: Renagel must not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).
Danish: Renagel må ikke anvendes af personer med hypophosphatæmi (lavt phosphatindhold i blodet) eller tarmobstruktion (en blokering af tarmen).
English: In the study of patients undergoing peritoneal dialysis, the patients receiving Renagel had similar falls in phosphate as the patients receiving calcium acetate (0.52 and 0.58 mmol/l, respectively).
Danish: I undersøgelsen med patienter, der gennemgik peritoneal dialyse, oplevede dem, der tog Renagel, et lignende fald i mængden af phosphat i blodet i forhold til dem, der tog kalciumacetat (henholdsvis 0,52 og 0,58 mmol/l).
English: What is Renagel used for?
Danish: Hvad anvendes Renagel til?
English: How has Renagel been studied?
Danish: Hvordan blev Renagel undersøgt?
English: Patients taking Renagel had a similar fall in phosphate levels in the second study.
Danish: I den anden undersøgelse havde patienter, der tog Renagel, et lignende fald i mængden af phosphat i blodet.
English: What benefit has Renagel shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Renagel?
English: How is Renagel used?
Danish: Hvordan anvendes Renagel?
English: How does Renagel work?
Danish: Hvordan virker Renagel?
English: List of the names, pharmaceutical forms, strength of the medicinal product, route of administration, marketing authorisation holder in the Member States
Danish: Liste over navne, lægemiddelformer, lægemiddelstyrke, indgivelsesvej, indehaver af markedsføringstilladelsen i medlemslandene
English: Member State EU/EEA
Danish: EU/EEAmedlemsland
English: Austria
Danish: Germany
English: Marketing authorisation holder
Danish: Indehaver af markedsføringstilladelse n
English: Goserelin Novosis 3,6 mg Implantat implant, pre-filled syringe subcutaneous use
Danish: Østrig implantat, fyldt injektionssprøjte
English: EMA Number
Danish: EMA's nummer
English: Date of opening:____________
Danish: Dato for åbning:____________
English: NA NA NA
Danish: NA NA
English: Efficacy Outcomes at Week 48a and at Week 96 (Study 045)
Danish: Effektresultater ved uge 48a og uge 96 (Studie 045)
English: In this instance, close clinical monitoring is warranted (see Interaction with other Medicinal Products below).
Danish: I dette tilfælde er tæt klinisk monitorering påkrævet (se Interaktion med andre lægemidler nedenfor).
English: Consistent results were obtained with the last observation carried forward method of analysis (time-averaged difference of 0.11, 97.5% confidence interval [-0.15, 0.36]).
Danish: Der blev opnået samstemmende resultater ved en analysemetode, hvor sidste observation blev fremskrevet (tidsgennemsnitlig forskel på 0,11; 97,5% konfidensinterval [-0,15; 0,36]).
English: Thirty-two percent of patients in the study had a viral strain with fewer than two NRTI substitutions.
Danish: 32% af patienterne i studiet havde en virusstamme med færre end to NRTI-substitutioner.
English: The potential for PR prolongation should be considered in cases of overdose (see section
Danish: Potentialet for PR-forlængelse bør tages i betragtning i tilfælde af overdosering (se pkt.
English: Table 2: Interactions between atazanavir and other medicinal products Medicinal products by therapeutic area
Danish: Tabel 2: Interaktioner mellem atazanavir og andre lægemidler Lægemiddel efter terapeutisk område
English: More frequent therapeutic concentration monitoring of these medicinal products is recommended until plasma levels have been stabilised.
Danish: Hyppigere monitorering af den terapeutiske koncentration af disse lægemidler anbefales indtil plasmaniveauerne er stabile.
English: Frequency is defined using the following convention: 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).
Danish: Hyppighed af bivirkninger er defineret i henhold til følgende konventionen: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000).
English: 90 (3 x 30) hard capsules
Danish: 90 (3 x 30) hårde kapsler
English: Moreover, in case of withdrawal of glucocorticoids, progressive dose reduction may have to be performed over a longer period.
Danish: det i tilfælde af seponering af glukokortikoidet være nødvendigt med progressiv dosisreduktion over en længere periode.
English: The studies presented in Table 2 were conducted in healthy subjects unless otherwise noted.
Danish: Studierne, der refereres til i tabel 2, er udført med raske frivillige medmindre andet er angivet.
English: An initial dose reduction of diltiazem by 50% is recommended, with subsequent titration as needed and ECG monitoring.
Danish: Initial dosisreduktion af diltiazem på 50% med efterfølgende titrering efter behov samt EKG-monitorering anbefales.
English: Therefore if the combination is unavoidable, the following recomendations are made according to the CYP2C19 status:
Danish: Hvis kombinationen ikke kan undgås, anbefales derfor følgende, afhængigt af CYP2C19-status:
English: b Cmin is concentration 24 hours post-dose
Danish: b Cmin er koncentrationen 24 timer efter dosering.
English: If you have liver problems, including hepatitis B or C infection, you may experience a worsening of your liver problems.
Danish: Hvis du har leverproblemer, herunder hepatitis B eller C-infektion, kan du opleve, at dine leverproblemer forværres.
English: For children (6 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight.
Danish: Til børn (fra 6 år til under 18 år) vil barnets læge beslutte, hvilken dosis der skal anvendes ud fra barnets vægt.
English: FC susceptibility in cell culture relative to the wild-type reference was assayed using PhenoSenseTM (Monogram Biosciences, South San Francisco, California, USA)
Danish: FC-følsomhed i cellekulturer hvad angår vildtypereference blev testet ved hjælp af PhenoSenseTM (Monogram Biosciences, South San Francisco, Californien, USA)
English: Method of administration For oral use.
Danish: Administration Til oral anvendelse.
English: If you feel dizzy or lightheaded, do not drive or use machines and contact your doctor immediately.
Danish: Hvis du føler dig svimmel eller uklar, må du ikke køre bil eller betjene maskiner og du skal straks kontakte lægen.
English: Efficacy Outcomes (paediatric patients 6 years to less than 18 years of age) at Week 48 (Study AI424-020)
Danish: Effektparametre (pædiatriske patienter fra 6 år til under 18 år) ved uge 48 (AI424-020 studie)
English: There were no cases of lactic acidosis observed in the clinical trial AI424-182.
Danish: Der blev ikke observeret laktacidose i det kliniske studie AI424-182.
English: Electrocardiographic changes (sinus bradycardia, prolongation of PR interval, prolongation of QT interval, and prolongation of QRS complex) were observed only in an initial 2 week oral toxicity study performed in dogs.
Danish: Elektrokardiografiske forandringer (sinusbradykardi, forlængelse af PR-interval, forlængelse af QT-interval og forlængelse af QRS-kompleks) blev kun observeret i en indledende 2-ugers oral toksicitetsstudie udført på hunde.
English: The rash usually disappears within 2 weeks without any change to your atazanavir treatment.
Danish: Udslættet forsvinder som regel inden for 2 uger uden at atazanavir-behandlingen ændres.
English: Atazanavir Krka capsules may be used by adults and children 6 years of age and older.
Danish: Atazanavir Krka kapsler kan anvendes af voksne og børn, der er 6 år og ældre.
English: Consult the dosing table for the specific formulation (see Summary of Product Characteristics for other formulations).
Danish: Se doseringstabellen for den pågældende formulering (se produktresuméet for andre formuleringer).
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Du kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral behandling.
English: Assessment of adverse reactions for atazanavir is based on safety data from clinical studies and postmarketing experience.
Danish: Evalueringen af atazanavirs bivirkninger er baseret på sikkerhedsdata fra kliniske studier og på erfaring efter markedsføring.
English: Unchanged drug accounted for approximately 20% and 7% of the administered dose in the faeces and urine, respectively.
Danish: Uomdannet lægemiddel udgjorde henholdsvis ca. 20% og 7% af den administrerede dosis i fæces og urin.
English: Increased clinical and laboratory monitoring for HIV suppression is warranted.
Danish: Øget klinisk monitorering og monitorering af laboratorieprøver for hiv-suppression er påkrævet.
English: Other interactions Interactions between atazanavir and other medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Danish: Andre interaktioner Interaktioner mellem atazanavir og andre lægemidler angives i tabellen nedenfor (stigninger er angivet med “↑”, fald med “↓”, ingen ændring med “↔”).
English: The signs may be a mild yellowing of the skin or eyes.
Danish: Symptomerne kan være svag gulfarvning af hud eller øjne.
English: There was an increase in the maximum PR interval compared to atazanavir alone.
Danish: Der sås forlængelse af det maksimale PR-interval sammenlignet med atazanavir alene.
English: Systemic lidocaine, Quinidine
Danish: Systemisk lidocain Quinidin
English: Age/Gender: a study of the pharmacokinetics of atazanavir was performed in 59 healthy male and female subjects (29 young, 30 elderly).
Danish: Alder/køn: Der er gennemført et farmakokinetisk studie af atazanavir med 59 raske mandlige og kvindelige forsøgspersoner (29 unge, 30 ældre).
English: - Changes in the way your heart beats (heart rhythm change) may occasionally happen.
Danish: - Ændringer i hjertets måde at slå på (hjerterytmeændringer) kan i nogle tilfælde opstå.
English: - if you have moderate to severe liver problems.
Danish: hvis du har moderate eller svære leverproblemer.
English: The use of Atazanavir Krka in children less than 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications.
Danish: Anvendelse af Atazanavir Krka til børn under 3 måneder og som vejer under 5 kg, er ikke blevet undersøgt på grund af risikoen for alvorlige komplikationer.
English: This way, you can be sure your medicine is fully effective and you reduce the risk of the virus developing resistance to the treatment.
Danish: Sådan kan du være sikker på, at medicinen virker bedst muligt, og risikoen for, at virusset udvikler resistens over for behandlingen, er mindre.
English: The fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82%89%).
Danish: Plasmaniveauet af fluticasonpropionat øges signifikant hvorimod intrinsic kortisol-niveauer falder med ca. 86% (90% KI 82%-89%).
English: Ritonavir capsules, tablets or oral solution.
Danish: Ritonavir kapsler, tabletter eller oral opløsning.
English: No recommendation regarding dose reduction can be made; therefore, caution should be exercised if atazanavir is coadministered with clarithromycin.
Danish: Der kan ikke gives anbefalinger vedrørende dosisreduktion; der bør derfor udvises forsigtighed, hvis atazanavir administreres samtidig med clarithromycin.
English: - Liver problems may uncommonly happen.
Danish: - Leverproblemer kan forekomme mindre hyppigt.
English: A dose reduction of clarithromycin may result in subtherapeutic concentrations of 14-OH clarithromycin.
Danish: Reduktion af clarithromycindosis kan medføre subterapeutiske koncentrationer af 14-OH-clarithromycin.
English: 15 to less than 35 At least 35
Danish: 15 til under 35 mindst 35
English: The study assessed 40 infants who received antiretroviral prophylactic treatment (which did not include atazanavir) and were negative for HIV-1 DNA at the time of delivery and/or during the first 6 months postpartum.
Danish: I studiet indgik 40 spædbørn, som fik profylaktisk antiretroviral behandling (som ikke omfattede atazanavir), og som var negative for hiv-1-dna på fødselstidspunktet og/eller i de første 6 måneder efter fødslen.
English: A moderate amount of data in pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative toxicity of atazanavir.
Danish: En moderat mængde data fra anvendelse af atazanavir hos gravide kvinder (mellem 300-1.000 graviditetsudfald) indikerer ingen misdannelser.
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Assessment of the pharmacokinetics, safety, tolerability, and efficacy of atazanavir is based on data from the open-label, multicenter clinical trial AI424-020 conducted in patients from 3 months to 21 years of age.
Danish: Vurdering af farmakokinetik, sikkerhed, tolerabilitet og virkning af atazanavir er baseret på data fra et åbent, klinisk multicenterstudie (AI424-020), der blev udført med patienter i alderen 3 måneder til 21 år.
English: Atazanavir Krka 300 mg with ritonavir 100 mg may not provide sufficient exposure to atazanavir, especially when the activity of atazanavir or the whole regimen may be compromised due to drug resistance.
Danish: Atazanavir Krka 300 mg med ritonavir 100 mg giver muligvis ikke tilstrækkelig eksponering for atazanavir, specielt i de tilfælde hvor aktiviteten af atazanavir eller af hele regimet er kompromitteret på grund af resistens.
English: Treatment of overdose with Atazanavir Krka should consist of general supportive measures, including monitoring of vital signs and electrocardiogram (ECG), and observations of the patient's clinical status.
Danish: Behandling af overdosering med Atazanavir Krka bør bestå af generelt understøttende tiltag, inklusive monitorering af vitale tegn og elektrokardiogram (EKG) samt observation af patientens kliniske status.