FrancophonIA/ELRC3.0 huggingface dataset:
English: Erythropoietin is produced by the kidneys.
Danish: Erythropoietin dannes i nyrerne.
English: Patients who receive Biopoin by injection under the skin may inject themselves once they have been trained appropriately.
Danish: Patienter, der får Biopoin som injektion under huden, kan injicere sig selv, når de har fået tilstrækkelig undervisning heri.
English: When the anaemia has been corrected, the dose in the ‘maintenance phase' should be adjusted to maintain the right level of haemoglobin.
Danish: Når anæmien er blevet korrigeret, skal dosis i "vedligeholdelsesfasen" justeres, så man bevarer det rette hæmoglobinniveau.
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Danish: Hos patienter, der får kemoterapi eller har nyreproblemer, kan anæmi opstå som følge af mangel på erythropoietin, eller fordi kroppen ikke reagerer tilstrækkeligt på det erythropoietin, den danner naturligt.
English: The most common side effects with Biopoin (seen in between 1 and 10 patients in 100) are shunt thrombosis (clots that can form in blood vessels of patients on dialysis, a blood clearance technique), headache, hypertension (high blood pressure), hypertensive crisis (sudden, dangerously high blood pressure), skin reactions, arthralgia (joint pain) and influenza (flu)-like illness.
Danish: De hyppigste bivirkninger ved Biopoin (som optræder hos mellem 1 og 10 patienter ud af 100) er shunttrombose (blodpropper hos patienter, der er i dialyse, en blodrensningsteknik), hovedpine, hypertension (forhøjet blodtryk), hypertensiv krise (pludseligt og farligt højt blodtryk), hudreaktioner, artralgi (ledsmerter) og influenzalignende sygdom.
English: The other two studies compared Biopoin with epoetin beta during the maintenance phase.
Danish: I de to andre undersøgelser sammenlignede man Biopoin med epoetin beta i vedligeholdelsesfasen.
English: The main measure of effectiveness was the average change in haemoglobin levels from 15 to 26 weeks after treatment.
Danish: Det primære effektmål var den gennemsnitlige ændring i hæmoglobinniveauet 15-26 uger efter behandling.
English: The weekly dose of Biopoin should not at any time be more than 700 IU per kg body weight.
Danish: Den ugentlige dosis Biopoin må ikke på noget tidspunkt overstige 700 IE pr. kg kropsvægt.
English: The main measure of effectiveness in two of these studies was based on whether increasing the dose of Biopoin from 20 or 40 IU per kg body weight to 120 IU per kg body weight led to improvements in haemoglobin levels during the correction phase.
Danish: Det primære effektmål i to af disse undersøgelser var baseret på, om en forøgelse af Biopoindosen fra 20 eller 40 IE pr. kg kropsvægt til 120 IE pr. kg kropsvægt førte til forbedringer i hæmoglobinniveauet i korrektionsfasen.
English: For patients with kidney failure, in the ‘correction phase', the initial recommended dose, given three times a week, is 20 IU per kilogram body weight for injections under the skin or 40 IU per kg body weight for injections into a vein.
Danish: Til patienter med nyreinsufficiens, som er i "korrektionsfasen", er den anbefalede startdosis, der gives tre gange om ugen, 20 IE pr. kilo kropsvægt for injektioner under huden eller 40 IE pr. kilo kropsvægt for injektioner i en vene.
English: Biopoin should not be used in people who may be hypersensitive (allergic) to epoetin theta, to any other epoetins or substances derived from them, or to any of the other ingredients of Biopoin.
Danish: Biopoin bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for epoetin theta, andre epoetiner eller afledte stoffer heraf eller andre af indholdsstofferne i Biopoin.
English: Biopoin is used to treat anaemia (low levels of red blood cells or haemoglobin) that is causing symptoms.
Danish: Biopoin anvendes til at behandle anæmi (lavt antal røde blodlegemer eller lavt hæmoglobinniveau), som giver symptomer.
English: There were four main studies in 842 chronic renal failure patients and three main studies in 586 nonmyeloid cancer patients receiving chemotherapy.
Danish: Der blev foretaget fire hovedundersøgelser af 842 patienter med kronisk nyreinsufficiens og tre hovedundersøgelser af 586 patienter med ikke-myeloid kræft, som fik kemoterapi.
English: The weekly dose of Biopoin should not be more than 60,000 IU.
Danish: Den ugentlige dosis Biopoin må ikke overstige 60.000 IE.
English: In the four renal failure studies, patients were given either Biopoin (under the skin or into a vein) or epoetin beta (another erythropoietin-like medicine used for anaemia).
Danish: I de fire undersøgelser af nyreinsufficiens fik patienterne enten Biopoin (som injektion under huden eller i en vene) eller epoetin beta (et andet erythropoietinlignende lægemiddel, der anvendes ved anæmi).
English: What is the risk associated with Biopoin?
Danish: Hvilken risiko er der forbundet med Biopoin?
English: For the full list of all side effects reported with Biopoin, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Biopoin fremgår af indlægssedlen.
English: The epoetin theta in Biopoin works in the body in the same way as the natural hormone to stimulate red blood cell production.
Danish: Epoetin theta i Biopoin virker på samme måde i kroppen som det naturlige hormon, der stimulerer dannelsen af røde blodlegemer.
English: The active substance in Biopoin, epoetin theta, is a copy of a human hormone called erythropoietin that stimulates the production of red blood cells from the bone marrow.
Danish: Det aktive stof i Biopoin, epoetin theta, er en kopi af det menneskelige hormon erythropoietin, som stimulerer dannelsen af røde blodlegemer fra knoglemarven.
English: Average weekly increases in haemoglobin were 0.73 and 0.58 g/dl in patients receiving the higher dose of Biopoin compared with 0.20 and 0.26 g/dl in patients receiving the lower dose of Biopoin.
Danish: De gennemsnitlige ugentlige stigninger i hæmoglobinniveauet lå på 0,73 og 0,58 g/dl hos de patienter, der fik den højeste dosis Biopoin, sammenlignet med 0,20 og 0,26 g/dl hos de patienter, der fik den laveste dosis Biopoin.
English: In chronic renal failure patients, the correction phase showed that increasing the starting dose of Biopoin leads to improvements in haemoglobin levels.
Danish: Hos patienter med kronisk nyreinsufficiens viste det sig i korrektionsfasen, at en forøgelse af startdosen af Biopoin førte til forbedringer af hæmoglobinniveauet.
English: Why has Biopoin been approved?
Danish: Hvorfor blev Biopoin godkendt?
English: In the cancer studies, the main measure of effectiveness was the number of patients receiving either Biopoin or placebo (a dummy treatment) with an increase in haemoglobin of 2 g/dl over 12 or 16 weeks.
Danish: I undersøgelsen af kræftpatienterne var det primære effektmål antallet af patienter, der fik enten Biopoin eller placebo (en virkningsløs behandling), og som havde en stigning i hæmoglobinniveauet på 2 g/dl i løbet af 12 eller 16 uger.
English: It is used in adults with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) and in adults with non-myeloid cancer (cancer not originating in the bone marrow) who are receiving chemotherapy (medicines to treat cancer).
Danish: Det anvendes hos voksne med kronisk nyreinsufficiens (langvarig, fremadskridende nedsættelse af nyrefunktionen) og hos voksne med ikke-myeloid kræft (kræft, som ikke stammer fra knoglemarven), som får kemoterapi (lægemidler til behandling af kræft).
English: Biopoin is a solution for injection.
Danish: Biopoin er en injektionsvæske, opløsning.
English: In the cancer studies, between 64 and 73% of patients who received Biopoin had an increase in haemoglobin of 2 g/dl compared with between 20 and 26% of patients who were given placebo.
Danish: I undersøgelserne af patienter med kræft havde mellem 64 % og 73 % af de patienter, der fik Biopoin, en stigning i hæmoglobinniveauet på 2 g/dl sammenlignet med mellem 20 % og 26 % af de patienter, der fik placebo.
English: The other two renal failure studies showed that during the maintenance stage the change in haemoglobin levels was similar in patients receiving Biopoin and patients receiving epoetin beta.
Danish: De to andre undersøgelser af patienter med nyreinsufficiens viste, at i vedligeholdelsesfasen var ændringen i hæmoglobinniveauet stort set den samme hos patienter, der fik Biopoin, og patienter, der fik epoetin beta.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Biopoin's benefits are greater than its risks for the treatment of symptomatic anaemia in adults with chronic renal failure and adults with non-myeloid cancers who are receiving chemotherapy.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Biopoin er større end risiciene ved Biopoin til behandling af symptomatisk anæmi hos voksne med kronisk nyreinsufficiens og voksne med ikke-myeloid kræft, der får kemoterapi.
English: Biopoin treatment should be started by a doctor experienced in treating symptomatic anaemia in patients with chronic renal failure and non-myeloid cancer.
Danish: Behandling med Biopoin skal indledes af en læge, der har erfaring med behandling af symptomatisk anæmi hos patienter med kronisk nyreinsufficiens og ikke-myeloid kræft.
English: What is Biopoin?
Danish: Hvad er Biopoin?
English: Biopoin was effective at treating anaemia in patients with chronic renal failure and patients with nonmyeloid cancer who were receiving chemotherapy.
Danish: Biopoin var effektivt til behandling af anæmi hos patienter med kronisk nyreinsufficiens og patienter med ikke-myeloid kræft, der får kemoterapi.
English: What benefit has Biopoin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Biopoin?
English: What is Biopoin used for?
Danish: Hvad anvendes Biopoin til?
English: How has Biopoin been studied?
Danish: Hvordan blev Biopoin undersøgt?
English: How is Biopoin used?
Danish: Hvordan anvendes Biopoin?
English: How does Biopoin work?
Danish: Hvordan virker Biopoin?
English: For full details, see the Package Leaflet.
Danish: Nærmere oplysninger fremgår af indlægssedlen.
English: 3 years
Danish: 3 år
English: Linearity/non-linearity
Danish: Linearitet/non-linearitet
English: Elderly patients (≥ 65 years)
Danish: Ældre patienter (≥ 65 år)
English: The major route of elimination of drug related radioactivity after oral administration of [
Danish: Den vigtigste eliminationsvej for lægemiddelrelateret radioaktivitet efter oral administration af [
English: OTHER Do not open before use.
Danish: ANDET Må ikke åbnes før brug.
English: Similar results were observed in analyses using a conservative threshold of 10%.
Danish: Der blev observeret lignende resultater i analyser, der benyttede en konservativ tærskelværdi på 10 %.
English: It is recommended that you take the capsules with food, i.e. during or immediately before or after a meal.
Danish: Det anbefales, at du tager kapslerne sammen med mad, dvs. under eller umiddelbart før eller efter et måltid.
English: Data from Black individuals were very limited but in the same range as for Caucasians.
Danish: Data fra sorte individer var meget begrænsede, men i samme størrelsesorden som hos kaukasiere.
English: A risk to the newborns/infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC:
English: - The other ingredients are:
Danish: - Øvrige indholdsstoffer:
English: Based on a Log-rank test.
Danish: Baseret på en Log-rank-test.
English: The treatment effect was consistent in both trials.
Danish: Behandlingseffekten var konsistent i begge studier.
English: Ofev is for oral use.
Danish: Ofev er til oral anvendelse.
English: Based on this information your doctor may do some blood tests, for example to check your liver function.
Danish: Ud fra disse oplysninger tager din læge måske nogle blodprøver, f.eks. for at kontrollere din leverfunktion.
English: Administration of Ofev may increase blood pressure.
Danish: Administration af Ofev kan øge blodtrykket.
English: It is important to take this medicine every day, as long as your doctor prescribes it for you.
Danish: Det er vigtigt, at du tager dette lægemiddel hver dag, så længe lægen ordinerer det til dig.
English: Survival analysis
Danish: Overlevelsesanalyse
English: Serum albumin is considered to be the major binding protein.
Danish: Serumalbumin anses for det vigtigste bindingsprotein.
English: No overall differences in safety and efficacy were observed for elderly patients.
Danish: Der sås ingen overordnede forskelle i sikkerhed og virkning hos ældre patienter.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: Do not take two capsules together if you have forgotten to take your earlier dose.
Danish: Tag ikke to kapsler samtidig, hvis du har glemt at tage din forrige dosis.
English: Based on data collected up to 372 days (52 weeks + 7 day margin).
Danish: Baseret på data indsamlet op til 372 dage (52 uger + 7 dages margin).
English: The following other side effects were observed during treatment with this medicine.
Danish: Følgende bivirkninger er observeret under behandling med dette lægemiddel.
English: These changes are known from other VEGFR-2 inhibitors and can be considered class effects.
Danish: Disse forandringer kendes fra andre VEGFR-2-hæmmere og kan anses for at være klasseeffekter.
English: If a dose is missed the patient should not take an additional dose.
Danish: Hvis man kommer til at springe en dosis over, bør patienten ikke tage en ekstra dosis.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: Close monitoring is recommended in patients with these risk factors.
Danish: Tæt kontrol af patienter med disse risikofaktorer anbefales.
English: Summary of the safety profile
Danish: Resumé af sikkerhedsprofilen
English: Based on a logistic regression.
Danish: Baseret på logistisk regression.
English: Based on a Cox's regression model.
Danish: Baseret på en Cox' regressionsmodel.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisteren.
English: Systemic blood pressure should be measured periodically and as clinically indicated.
Danish: Det systemiske blodtryk bør måles regelmæsigt og som klinisk indiceret.
English: P-glycoprotein (P-gp)
Danish: P-glykoprotein (P-gp)
English: Your doctor will discuss the results of these tests with you and decide whether you may receive Ofev.
Danish: Din læge taler med dig om resultaterne af disse undersøgelser og afgør, om du må få Ofev.
English: Studies in paediatric populations have not been performed.
Danish: Der er ikke udført studier på den pædiatriske population.
English: Diarrhoea (very common, may affect more than 1 in 10 people):
Danish: Diarré (meget almindelig, kan forekomme hos flere end 1 ud af 10 patienter):
English: Patients should then be monitored at regular intervals during the subsequent two months of treatment and periodically thereafter, e.g. at each patient visit or as clinically indicated.
Danish: Patienterne bør derefter monitoreres med regelmæssige mellemrum i løbet af de næste 2 måneders behandling, og regelmæssigt derefter (f.eks. ved hvert patientbesøg) eller som klinisk indiceret.
English: FVC responder analysis
Danish: FVC-responder-analyse
English: Patients with low body weight (< 65 kg), Asian and female patients have a higher risk of elevations of liver enzymes.
Danish: Patienter med lav legemsvægt (< 65 kg), asiatiske og kvindelige patienter har en større risiko for forhøjelser af leverenzymer.
English: There is no specific antidote or treatment for Ofev overdose.
Danish: Der findes ingen specifik antidot mod eller behandling af overdosering med Ofev.
English: Therefore these patients should only be treated with Ofev if the anticipated benefit outweighs the potential risk.
Danish: Derfor skal disse patienter kun behandles med Ofev, hvis den forventede fordel opvejer den mulige risiko.
English: You need to pay special attention if you get the following side effects during treatment with Ofev:
Danish: Du skal være særlig opmærksom, hvis du får følgende bivirkninger under behandlingen med Ofev:
English: In case of overdose, treatment should be interrupted and general supportive measures initiated as appropriate.
Danish: I tilfælde af overdosering skal behandlingen afbrydes og generel understøttende behandling iværksættes efter behov.
English: Soft capsule (capsule).
Danish: Blød kapsel (kapsel).
English: Steady state plasma concentrations were achieved within one week of dosing at the latest.
Danish: Steady state plasmakoncentrationer blev opnået senest inden for en uge efter dosering.
English: Annual rate of decline in FVC
Danish: Årlig grad af forværring i FVC
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: If a dose is missed, administration should resume at the next scheduled time at the recommended dose.
Danish: Hvis man kommer til at springe en dosis over, bør administrationen genoptages på det næste planlagte tidspunkt og i den anbefalede dosis.
English: Do not use this medicine if you notice that the blister containing the capsules is opened or a capsule is broken.
Danish: Brug ikke lægemidlet, hvis du bemærker, at blisteren (pakningen), som indeholder kapslerne, er åbnet, eller hvis en kapsel er i stykker.
English: Frequency categories are 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), not known (cannot be estimated from the available data).
Danish: Følgende hyppighedskategorier er defineret vha. følgende konvention: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The primary endpoint was the annual rate of decline in Forced Vital Capacity (FVC).
Danish: Det primære endepunkt var det årlige fald i forceret vitalkapacitet (FVC).
English: Inform your doctor immediately while taking this medicine, - if you get diarrhoea.
Danish: Kontakt omgående din læge, mens du tager dette lægemiddel, - hvis du får diarré.
English: The recommended maximum daily dose of 300 mg should not be exceeded.
Danish: Den anbefalede højeste daglige dosis på 300 mg må ikke overskrides.
English: You should not drive or use machines if you feel sick.
Danish: Du må ikke føre motorkøretøj eller betjene maskiner, hvis du har det dårligt.
English: As nintedanib may cause foetal harm also in humans, it must not be used during pregnancy.
Danish: Da nintedanib måske også kan forårsage fosterskader hos mennesker, må det ikke anvendes under graviditet.
English: The overall recovery was considered complete (above 90%) within 4 days after dosing.
Danish: Den samlede genfinding ansås for at være fuldstændig (over 90 %) inden for 4 dage efter dosering.
English: The difference between the treatment groups reached nominal statistical significance (p=0.0136).
Danish: Forskellen mellem behandlingsgrupperne nåede nominel statistisk signifikans (p=0,0136).
English: The major CYP-dependent metabolite could not be detected in plasma in the human ADME study.
Danish: Den vigtigste CYP-afhængige metabolit kunne ikke måles i plasma hos mennesker i ADME-studiet.
English: Package leaflet: Information for the patient
Danish: Indlægsseddel: Information til patienten
English: In such cases, patients should be monitored closely for tolerability of nintedanib.
Danish: I sådanne tilfælde bør patienterne kontrolleres tæt med hensyn til tolerabilitet af nintedanib.
English: Time to first acute IPF exacerbation
Danish: Tid til den første akutte IPF-eksacerbation
English: In patients with missing data, the primary analysis assumes that the decline in FVC after the last observed value would be similar to the decline in other patients in the same treatment group.
Danish: Hos patienter, hvor data mangler, antager den primære analyse, at faldet i FVC efter den sidste observerede værdi vil være sammenligneligt med faldet hos andre patienter i den samme behandlingsgruppe.
English: The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.
Danish: Brug af VEGF-hæmmere hos patienter med eller uden hypertension kan fremme dannelse af aneurismer og/eller arterielle dissektioner.
English: Do not reduce the dose or stop the treatment by yourself without consulting your doctor first.
Danish: Du må ikke selv nedsætte dosis eller afbryde behandlingen uden først at tale med din læge.
English: At the first signs of diarrhoea drink plenty of fluids and contact your doctor immediately.
Danish: Ved de første tegn på diarré skal du drikke rigeligt med væske og omgående kontakte lægen.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Absorption and bioavailability are decreased by transporter effects and substantial first-pass metabolism.
Danish: Absorption og biotilgængelighed nedsættes af transporter-effekt og en betydelig førstepassagemetabolisme.
English: Women who can become pregnant must use an effective combination of birth control methods, including barrier methods as a second form of contraception, while they are taking Ofev and for at least 3 months after stopping treatment.
Danish: Kvinder, der kan blive gravide, skal anvende en effektiv kombination af præventionsmetoder, herunder barrieremetoder som en ekstra form for prævention, mens de tager Ofev og i mindst 3 måneder efter, behandlingen er stoppet.
English: See leaflet for further information.
Danish: Se indlægssedlen for yderligere information.
English: Change from baseline in SGRQ total score at week 52
Danish: Ændring fra baseline i samlet SGRQ-score i uge 52
English: AUCτ,ss increased by 25% for a 50 kg patient (5
Danish: AUCτ,ss steg med 25 % hos en patient på 50 kg (5 %
English: Take the capsules twice daily approximately 12 hours apart at about the same time every day, for example one capsule in the morning and one capsule in the evening.
Danish: Tag én kapsel to gange dagligt med ca. 12 timers mellemrum på omtrent samme tidspunkt af dagen, f.eks. én kapsel om morgenen og én kapsel om aftenen.
English: Effects on the development of the axial skeleton and on the development of the great arteries were also noted at subtherapeutic exposure levels.
Danish: Der blev også fundet effekt på udviklingen af det aksiale skelet og af de store arterier ved subterapeutiske eksponeringsniveauer.
English: The results of all survival endpoints (such as on-treatment mortality and respiratory mortality) showed a consistent numerical difference in favour of nintedanib.
Danish: Resultaterne af alle overlevelsesendepunkter (såsom i-behandlings-mortalitet og respiratorisk mortalitet) viste en konsistent numerisk forskel til fordel for nintedanib.