FrancophonIA/ELRC3.0 huggingface dataset:
English: The effectiveness of NovoSeven was assessed by looking at its effect on the volume of the haemorrhage inside the brain, measured using a scan (percentage change in the volume after 24 hours of treatment with NovoSeven or placebo).
Danish: Effekten af NovoSeven blev vurderet ved at se på lægemidlets virkning på omfanget af hæmorrhagien inde i hjernen, målt ved hjælp af en skanning (volumenændring opgjort i procent efter 24 timers behandling med NovoSeven eller placebo).
English: In addition, there were concerns on the thromboembolic side effects (excessive clotting) for this indication, but the number of patients treated was too small for the CHMP to be able to balance this risk against the potential benefit.
Danish: Endvidere var der betænkeligheder ved de tromboemboliske bivirkninger (øget tendens til størkning) ved denne indikation, men antallet af behandlede patienter var for småt til, at CHMP mente, at den potentielle effekt opvejer denne risiko.
English: It is also used in patients with acquired haemophilia, in patients with congenital factor VII deficiency, and in patients with Glanzmann's thrombasthenia (a rare bleeding disorder) who cannot be treated by a transfusion of platelets.
Danish: Det anvendes også til patienter med erhvervet hæmofili, til patienter med medfødt faktor VII-mangel og til patienter med Glanzmanns trombasteni (en sjælden blødersygdom), som ikke kan behandles med transfusion af blodplader.
English: What is happening for NovoSeven used in other conditions?
Danish: Hvad sker der med NovoSeven anvendt til andre lidelser?
English: The Company has informed the CHMP that the current clinical trial of NovoSeven in intracerebral haemorrhage will continue.
Danish: Firmaet har underrettet CHMP om, at de nuværende kliniske undersøgelser af NovoSeven til behandling af intracerebral hæmorrhagi fortsætter.
English: The main concern of the CHMP was that the data were too limited to evaluate the benefit and the potential risks of NovoSeven in intracerebral haemorrhage.
Danish: CHMP's vigtigste betænkelighed var, at dataene var for begrænsede til at kunne vurdere effekten af og de potentielle risici ved NovoSeven til behandling af intracerebral hæmorrhagi.
English: NovoSeven was to be used to treat adult patients with intracerebral haemorrhage (bleeding inside the brain).
Danish: NovoSeven skulle have været anvendt til at behandle voksne patienter med intracerebral hæmorrhagi (blødning inde i hjernen).
English: NovoSeven contains eptacog alfa (activated), which is a blood coagulation factor protein.
Danish: NovoSeven indeholder eptacog alfa (aktiveret), som er et blodkoagulationsfaktorprotein.
English: NovoSeven is currently used for the treatment and prevention of bleeding connected with surgery in patients with haemophilia who have developed ‘inhibitors' (antibodies) to factor VIII or IX.
Danish: NovoSeven anvendes nu til behandling og forebyggelse af blødning i forbindelse med kirurgiske indgreb hos patienter med hæmofili, som har udviklet ‘inhibitorer' (antistoffer) over for faktor VIII eller IX).
English: NovoSeven was expected to limit the bleeding, and so reduce the consequences of the intracerebral haemorrhage.
Danish: NovoSeven forventedes at begrænse blødningen og således reducere konsekvenserne af den intracerebrale hæmorrhagi.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with NovSeven?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med NovoSeven eller i programmer for anvendelse med særlig udleveringstilladelse?
English: NovoSeven is a powder and solvent for injection that contains the active substance eptacog alfa (activated human recombinant coagulation factor VII).
Danish: NovoSeven er et pulver og en solvens til injektion, som indeholder det aktive stof eptacog alfa (aktiveret human rekombinant koagulationsfaktor VII).
English: In intracerebral haemorrhage, NovoSeven is expected to slow down the bleeding and the spread of the haemorrhage, thus improving the outcome for the patient.
Danish: NovoSeven forventes ved intracerebral hæmorrhagi at bremse blødningen og spredningen af hæmorrhagien, hvorved behandlingsresultatet forbedres for patienten.
English: In the body, eptacog alfa acts like one of the substances involved in blood coagulation (clotting), Factor VII.
Danish: Eptacog alfa fungerer i kroppen som et af de stoffer, der indgår i blodkoagulation (størkning), faktor VIII.
English: What was NovoSeven expected to be used for this indication?
Danish: Hvilken indikation forventedes NovoSeven anvendt til?
English: London, 27 April 2006 Doc.Ref.
Danish: London, den 27. april 2006 CHMP/154955/2006
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Danish: To lægemidler er bioækvivalente, når de frembringer samme indhold af det aktive stof i kroppen og derfor forventes at have samme virkning.
English: The full EPAR for Entecavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Entecavir Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: When treatment is considered appropriate in children, the dose depends on their body weight.
Danish: Når det anses for hensigtsmæssigt at behandle børn, afhænger dosis af deres legemsvægt.
English: It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease.
Danish: Det kan derudover overvejes at anvende lægemidlet til børn mellem 2 og 18 år, men kun ved kompenseret leversygdom.
English: Entecavir Mylan is taken once a day.
Danish: Entecavir Mylan tages én gang dagligt.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden har desuden udført en undersøgelse, der viser, at det er "bioækvivalent" med referencelægemidlet.
English: This is a summary of the European public assessment report (EPAR) for Entecavir Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Entecavir Mylan.
English: As for every medicine, the company provided studies on the quality of Entecavir Mylan.
Danish: Som for ethvert andet lægemiddel har virksomheden fremlagt undersøgelser af kvaliteten af Entecavir Mylan.
English: The treatment duration is determined by how the patient responds.
Danish: Behandlingens varighed afhænger af, hvor godt behandlingen virker på patienten.
English: The Agency recommended that Entecavir Mylan be approved for use in the EU.
Danish: Agenturet anbefalede, at Entecavir Mylan godkendes til anvendelse i EU.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Baraclude, and do not need to be repeated for Entecavir Mylan.
Danish: Fordelene og risiciene ved det aktive stof til de godkendte anvendelser er i forvejen undersøgt med referencelægemidlet Baraclude og behøver ikke gentages for Entecavir Mylan.
English: For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Entecavir Mylan (a nucleoside analogue, such as lamivudine).
Danish: Til voksne med kompenseret leversygdom afhænger dosis af, om patienten tidligere er blevet behandlet med et lægemiddel i samme gruppe som Entecavir Mylan (en nukleosidanalog såsom lamivudin).
English: It is used in adults with signs of ongoing liver injury (such as inflammation and fibrosis) when the liver is still working properly (compensated liver disease) and also when the liver is no longer working properly (decompensated liver disease).
Danish: Det anvendes hos voksne med tegn på aktiv leversygdom (såsom irritationstilstand (inflammation) og øget bindevævsdannelse (fibrose)), dels når leveren stadig fungerer korrekt (kompenseret leversygdom), og dels når den ikke længere fungerer korrekt (dekompenseret leversygdom).
English: Entecavir Mylan can only be obtained with a prescription and is available as tablets (0.5 mg and 1 mg).
Danish: Entecavir Mylan udleveres kun efter recept og fås som tabletter (0,5 mg og 1 mg).
English: Because Entecavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Entecavir Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: Treatment with Entecavir Mylan should be started by a doctor with experience in the management of chronic hepatitis B.
Danish: Behandlingen med Entecavir Mylan bør iværksættes af en læge med erfaring i behandling af kronisk hepatitis B.
English: The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.
Danish: En dosis på 1 mg dagligt anvendes desuden ved dekompenseret leversygdom hos voksne, og hos sådanne patienter frarådes det at ophøre med behandlingen.
English: What are the benefits and risks of Entecavir Mylan?
Danish: Hvilke fordele og risici er der forbundet med Entecavir Mylan?
English: This means that Entecavir Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Baraclude.
Danish: Det betyder, at Entecavir Mylan indeholder samme aktive stof og virker som et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU) og hedder Baraclude.
English: What measures are being taken to ensure the safe and effective use of Entecavir Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Entecavir Mylan?
English: Therefore, the Agency's view was that, as for Baraclude, the benefit outweighs the identified risk.
Danish: Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Baraclude.
English: It is not intended to provide practical advice on how to use Entecavir Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Entecavir Mylan bør anvendes.
English: Children weighing 32.6 kg and above can be given the 0.5 mg tablets, while an oral solution of entecavir should be used for children weighing less than 32.6 kg. For further information, see the package leaflet.
Danish: Børn på 32,6 kg og derover kan få tabletter på 0,5 mg, mens der til børn under 32,6 kg bør anvendes en oral opløsning af entecavir.
English: Entecavir Mylan contains the active substance entecavir and is a ‘generic medicine'.
Danish: Entecavir Mylan indeholder det aktive stof entecavir og er et "generisk lægemiddel".
English: For more information about treatment with Entecavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Entecavir Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose.
Danish: Til patienter, der ikke tidligere er behandlet med en nukleosidanalog, anvendes en dosis på 0,5 mg. Til dem, der tidligere har fået lamivudin, men hos hvem dette ikke længere virker på infektionen, anvendes en dosis på 1 mg.
English: Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Danish: Entecavir standser virussets DNA-produktion og dermed dets formering og spredning.
English: Entecavir Mylan is a medicine used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
Danish: Entecavir Mylan er et lægemiddel til behandling af langvarig (kronisk) hepatitis B, der er smitsom leverbetændelse forårsaget af hepatitis B-virus.
English: The active substance in Entecavir Mylan, entecavir, is an antiviral belonging to the class of the nucleoside analogues.
Danish: Det aktive stof i Entecavir Mylan, entecavir, er et antiviralt middel, der tilhører gruppen nukleosidanaloger.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Entecavir Mylan has been shown to have comparable quality and to be bioequivalent to Baraclude.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Entecavir Mylan er påvist at være af samme kvalitet som Baraclude og er bioækvivalent med dette i overensstemmelse med EU-reglerne.
English: What is Entecavir Mylan and what is it used for?
Danish: Hvad er Entecavir Mylan, og hvad anvendes det til?
English: Other information about Entecavir Mylan
Danish: Andre oplysninger om Entecavir Mylan
English: For practical information about using Entecavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Entecavir Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Danish: Entecavir hæmmer et virus-enzym, DNA-polymerase, som medvirker ved dannelsen af virus-DNA.
English: Why is Entecavir Mylan approved?
Danish: Hvorfor blev Entecavir Mylan godkendt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Entecavir Mylan have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er anført anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Entecavir Mylan.
English: How has Entecavir Mylan been studied?
Danish: Hvordan blev Entecavir Mylan undersøgt?
English: How is Entecavir Mylan used?
Danish: Hvordan anvendes Entecavir Mylan?
English: How does Entecavir Mylan work?
Danish: Hvordan virker Entecavir Mylan?
English: Do not take more than 1 tablet per day.
Danish: Du må ikke tage mere end 1 tablet om dagen.
English: and will tell you how long to take these other medicines.
Danish: Lægen vil fortælle dig, hvor længe du skal tage disse andre lægemidler.
English: Swallow the tablet whole with water and after breakfast in the morning.
Danish: Slug tabletten hel sammen med vand og efter morgenmaden om morgenen.
English: Coadministration of these 2 active substances is generally not recommended.
Danish: Samtidig administration af disse to aktive stoffer kan generelt ikke anbefales.
English: Blood count monitoring should therefore be performed at regular intervals.
Danish: Monitorering af blodtal skal derfor udføres med regelmæssige mellemrum.
English: Estimates range from 13 to 30 hours in man.
Danish: Estimater varierer fra 13 til 30 timer i mennesket.
English: The recommended dose is 1 tablet once a day in the morning.
Danish: Den anbefalede dosis er 1 tablet én gang dagligt om morgenen.
English: Duzallo should be taken in the morning with food and water.
Danish: Duzallo skal tages om morgenen sammen mad og vand.
English: There should be an interval of at least 3 hours between the concomitant use of those medicinal products.
Danish: Der skal være et interval på mindst 3 timer mellem indtag af disse lægemidler.
English: Experience in very elderly patients (≥75 years) is limited.
Danish: Erfaring med meget ældre patienter (≥ 75 år) er begrænset.
English: The use of genotyping has not been established in other patient populations.
Danish: Brug af genotypebestemmelse er ikke fastlagt i andre patientpopulationer.
English: These serious skin reactions can be more common in:
Danish: Disse alvorlige hudreaktioner kan være hyppigere hos:
English: Concomitant use which needs to be taken into consideration:
Danish: Samtidig anvendelse, der skal tages i betragtning:
English: Drink plenty of water during the day to reduce the risk of kidney stones.
Danish: Drik masser af vand i løbet af dagen for at reducere risikoen for nyresten.
English: The large discrepancies in these values may be accounted for by variations in study design and/or creatinine clearance in the patients.
Danish: De store afvigelser i disse værdier kan måske tilskrives variationer i studiedesignet og/eller kreatinin clearance hos patienterne.
English: The clinical relevance is not clear.
Danish: Den kliniske relevans er ikke klar.
English: Reported values for the elimination half-life range from 13.6 hours to 29 hours.
Danish: Indberettede værdier for eliminationshalveringstiden varierer fra 13,6 til 29 timer.
English: Chronic kidney disease may increase the risk in these patients additionally.
Danish: Kronisk nyresygdom kan øge risikoen yderligere hos disse patienter.
English: Studies in animals with lesinurad do not indicate direct or indirect harmful effects.
Danish: Dyrestudier med lesinurad tyder ikke på direkte eller indirekte skadelige virkninger.
English: There is no specific treatment in the event of an overdose, and symptoms of overdose are not established.
Danish: Der findes ingen specifik behandling i tilfælde af overdosering, og symptomerne på overdosering er ikke klarlagt.
English: Skin reactions are the most common reactions and may occur at any time during treatment.
Danish: Hudreaktioner er de mest almindelige reaktioner og kan forekomme på ethvert tidspunkt under behandlingen.
English: There are no data from the use of lesinurad and limited amount of data from the use of allopurinol in pregnant women.
Danish: Der findes ingen data fra brug af lesinurad og kun begrænset data fra brug af allopurinol hos gravide kvinder.
English: Angina pectoris, bradycardia
Danish: Angina pectoris, bradykardi
English: Patients should be instructed to stay well hydrated.
Danish: Patienter skal instrueres i at være velhydrerede.
English: ATC code: M04AA51
Danish: ATC-kode: M04AA51
English: The highest risk for SJS and TEN, or other serious hypersensitivity reactions, is within the first weeks of treatment.
Danish: Den største risiko for SJS og TEN eller andre alvorlige overfølsomhedsreaktioner ses inden for de første uger af behandlingen.
English: Lesinurad is extensively bound to proteins in plasma (greater than 98%), mainly to albumin.
Danish: Lesinurad bindes i høj grad til plasmaproteiner (mere end 98 %), hovedsageligt til albumin.
English: Wait and take your next dose of Duzallo the next morning.
Danish: Vent med at tage den næste dosis af Duzallo til næste morgen.
English: Alternative methods of contraception should be considered.
Danish: Brug af alternative præventionsmidler bør overvejes.
English: If such reactions do occur, it may be at any time during treatment, Duzallo should be withdrawn immediately and permanently.
Danish: Hvis sådanne reaktioner forekommer, på hvilket som helst under behandlingen, skal Duzallo seponeres øjeblikkeligt og permanent.
English: Most of the radioactivity recovered in urine (>60% of dose) occurred in the first 24 hours.
Danish: Det meste af den radioaktivitet, der blev genfundet i urin (> 60 % af dosis), blev genfundet i de første 24 timer.
English: Your doctor will tell you if additional doses of allopurinol are still necessary.
Danish: Lægen vil fortælle dig, om det stadig er nødvendigt at tage ekstra doser af allopurinol.
English: Patients should be closely monitored for therapeutic response and theappearance of toxicity.
Danish: Patienterne skal monitoreres tæt for terapeutisk respons og forekomst af toksicitet.
English: • people of Han Chinese, Thai or Korean origin
Danish: • personer af hankinesisk, thailandsk eller koreansk oprindelse.
English: - you have or have had heart failure or other heart problems - your gout gets worse
Danish: - hvis du har eller har haft hjertesvigt eller andre hjerteproblemer - hvis din urinsyregigt bliver værre
English: However, no data are available.
Danish: Der er dog ingen tilgængelige data.
English: Allopurinol has a plasma half-life of about 0.5 to 1.5 hours.
Danish: Allopurinol har en plasmahalveringstid på ca. 0,5 til 1,5 timer.
English: An induction effect of lesinurad should be anticipated after 2 to 3 weeks of continuous co-administration of Duzallo.
Danish: En inducerende effekt af lesinurad må forventes efter 2-3 ugers kontinuerlig samtidig administration af Duzallo.
English: The possibility of an increased occurrence of ciclosporin-specific adverse reactions is to be considered.
Danish: Muligheden for en øget forekomst af ciclosporin-specifikke bivirkninger skal tages i betragtning.
English: Duzallo is a tablet to be taken by mouth.
Danish: Duzallo er en tablet, der indtages gennem munden.
English: Across both studies, 61% of patients had mild or moderate renal impairment and 19% had tophi at baseline.
Danish: På tværs af begge studier havde 61 % af patienterne let eller moderat nedsat nyrefunktion, og 19 % havde tofi ved baseline.
English: Renal clearance is 25.6 mL/min (coefficient of variation CV=56%).
Danish: Renal clearance er 25,6 ml/min (variationskoefficient CV= 56 %).
English: Do not drive or operate machinery if you are affected.
Danish: Du må ikke føre motorkøretøj eller betjene maskiner, hvis du oplever dette.
English: Not recommended concomitant use with:
Danish: Samtidig anvendelse anbefales ikke med:
English: All patients receiving coumarin anticoagulants must be carefully monitored.
Danish: Alle patienter, der får kumarin-antikoagulantia, skal overvåges omhyggeligt.
English: Lesinurad is administered as a 50:50 mixture of lesinurad atropisomers.
Danish: Lesinurad administreres som en 50:50 blanding af lesinurad-atropisomerer.
English: The cause of the reported association has not been established.
Danish: Årsagen til den indberettede forbindelse er ikke blevet faslagt.
English: An interaction between allopurinol and coumarins has been seen under experimental conditions.
Danish: En interaktion mellem allopurinol og kumariner er blevet observeret under eksperimentelle forhold.
English: The frequency of the HLA-B*5801 allele varies widely between ethnic populations: up to 20% in Han Chinese population, 8-15% in the Thai, about 12% in the Korean population and 1-2% in individuals of Japanese or European origin.
Danish: Frekvensen af HLA-B*5801-allelen varierer bredt mellem etniske populationer: op til 20 % i den hankinesiske befolkning, 8-15 % i den thailandske befolkning, ca. 12 % i den koreanske befolkning og 1-2 % hos personer af japansk eller europæisk oprindelse.
English: SJS/TEN can still occur in patients who are found to be negative for HLA-B*5801 irrespective of their ethnic origin.
Danish: SJS/TEN kan stadig forekomme hos patienter, der er testet negative for HLA-B*5801, uanset deres etniske oprindelse.
English: Frequency categories are defined according to the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000) and very rare
Danish: Kategorierne for hyppighed er defineret efter 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) og meget sjælden (< 1/10.000).
English: This may decrease the therapeutic activity of Duzallo which contains the active substance allopurinol, but the significance needs to be assessed in each case.
Danish: Dette kan nedsætte den terapeutiske aktivitet af Duzallo, som indeholder det aktive stof allopurinol, men betydningen skal vurderes i hvert enkelt tilfælde.
English: Following multiple once daily dosing of lesinurad, there was no evidence of time dependent changes in pharmacokinetic properties and dose proportionality was preserved.
Danish: Efter gentagen dosering af lesinurad én gang dagligt var der ingen dokumentation for tidsafhængige ændringer i de farmakokinetiske egenskaber, og dosisproportionaliteten var bevaret.