FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information can be found in the summary of the risk management plan.
Danish: Yderligere information findes i sammenfatningen af risikostyringsplanen.
English: The recommended dose is 4 tablets once a day for the first 2 weeks and then 2 tablets taken 3 times a week for the next 22 weeks.
Danish: Den anbefalede dosis er 4 tabletter én gang dagligt de første 2 uger, derefter 2 tabletter 3 gange om ugen de næste 22 uger.
English: Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Danish: Hvert år gennemgår Det Europæiske Lægemiddelagentur alle nye oplysninger, der fremkommer, og ajourfører om nødvendigt dette sammendrag.
English: In addition, it is recommended that patients are directly observed by a healthcare professional as they take the medicine.
Danish: Desuden anbefales det, at patienterne direkte observeres af en sundhedsperson, når de tager lægemidlet.
English: The company will also provide longer term safety data on the medicine.
Danish: Virksomheden skal desuden forelægge mere langsigtede sikkerhedsdata om lægemidlet.
English: This is a summary of the European public assessment report (EPAR) for Sirturo.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sirturo.
English: Sirturo bedaquiline
Danish: Sirturo bedaquilin
English: The tablets should be taken with food.
Danish: Tabletterne skal tages med et måltid.
English: It is given when combinations without Sirturo cannot be used, either because the disease is resistant to them or because of their side effects.
Danish: Det anvendes, når kombinationsbehandlinger uden Sirturo ikke kan anvendes, enten fordi sygdommen er resistent mod dem, eller på grund af deres bivirkninger.
English: Treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis.
Danish: Behandlingen skal iværksættes og overvåges af en læge med erfaring i behandling af multiresistent tuberkulose.
English: Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis.
Danish: Tuberkulose er en infektion, der forårsages af bakterien Mycobacterium tuberculosis.
English: A risk management plan has been developed to ensure that Sirturo is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Sirturo anvendes så risikofrit som muligt.
English: Because the number of patients with tuberculosis is low in the EU, the disease is considered ‘rare', and Sirturo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 August 2005.
Danish: Da antallet af patienter med tuberkulose er lavt i EU, betragtes sygdommen som “sjælden”, og Sirturo blev udpeget som “lægemiddel til sjældne sygdomme” den 26. august 2005.
English: This means that there is more evidence to come about the medicine, which the company is required to provide.
Danish: Det betyder, at der for lægemidlet forventes yderligere dokumentation, som virksomheden skal fremskaffe.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Sirturo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Sirturo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Other information about Sirturo
Danish: Andre oplysninger om Sirturo
English: Without the ability to generate energy, the bacteria die and the patient's condition can start to improve.
Danish: Når bakterien ikke kan producere energi, dør den, og patienten kan begynde at få det bedre.
English: The Committee highlighted the need for new medicines to treat multi-drug resistant tuberculosis and noted that Sirturo was the first of a new class of medicines for which cross-resistance with other medicines had not yet been seen.
Danish: Udvalget understregede behovet for nye lægemidler til behandling af multiresistent tuberkulose og bemærkede, at Sirturo var det første i en ny klasse lægemidler, for hvilke der endnu ikke var set krydsresistens med andre lægemidler.
English: The study showed that after 24 weeks, 79% of the patients given Sirturo (52 out of 66 patients) tested negative for the bacteria in the sputum (phlegm) compared with 58% of patients given placebo (38 out of 66 patients).
Danish: Undersøgelsen viste, at efter 24 uger blev 79 % af de patienter, der fik Sirturo (52 ud af 66 patienter) testet negative for bakterierne i deres ophostede slim, sammenholdt med 58 % af de patienter, der fik placebo (38 ud af 66 patienter).
English: Although an analysis of these deaths did not support the conclusion that they were caused by Sirturo, the CHMP has required the company to provide more information from a long-term follow-up study to allay any concerns.
Danish: Skønt en gennemgang af disse dødsfald ikke gav grund til at antage, at de var forårsaget af Sirturo, har CHMP bedt virksomheden forelægge flere oplysninger fra langtidsopfølgning for at fjerne alle betænkeligheder.
English: The full EPAR and risk management plan summary for Sirturo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og en sammenfatning af risikohåndteringsplanen for Sirturo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Sirturo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sirturo?
English: There was also a higher number of reported deaths in the Sirturo group.
Danish: Desuden var antallet af dødsfald i Sirturo-gruppen større.
English: The most common side effects with Sirturo (which may affect more than 1 in 10 people) are headache, dizziness, nausea (feeling sick), vomiting, and arthralgia (joint pain).
Danish: De almindeligste bivirkninger med Sirturo (som kan forekomme hos mere end 1 af hver 10 behandlede) er svimmelhed, kvalme, opkastning og ledsmerter (artralgi).
English: The medicine is available as 100 mg tablets.
Danish: Sirturo leveres som 100 mg tabletter.
English: Since Sirturo has been granted a conditional approval, the company that markets Sirturo will provide additional data on the medicine's benefits and safety when used with different combinations of medicines.
Danish: Da der er udstedt en betinget godkendelse fra Sirturo, skal den virksomhed, der markedsfører Sirturo, forelægge supplerende oplysninger om lægemidlets fordele og sikkerhed ved anvendelse sammen med forskellige kombinationer af lægemidler.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Sirturo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Sirturo findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Sirturo increased the number of patients who tested negative for the tuberculosis bacteria and shortened the average time it took to clear the bacteria from the sputum.
Danish: Sirturo øgede antallet af patienter, der blev testet negative for tuberkulosebakterien, og afkortede gennemsnitlige tid, der gik, indtil den ophostede slim var fri for bakterien.
English: With regard to safety, the side effects reported in the Sirturo group in the main study were not markedly different from those in the placebo group, though there were higher levels of liver enzymes and some reports of alterations in the heart's electrical activity (known as prolonged QT interval).
Danish: Hvad sikkerheden angår, var de beskrevne bivirkninger med Sirturo i hovedundersøgelsen ikke særligt forskellige fra bivirkningerne med placebo, skønt der var forhøjet niveau af leverenzymer og i nogle tilfælde forandringer i hjertets elektriske aktivitet (forlænget QT-interval).
English: For more information about treatment with Sirturo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sirturo, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Sirturo has been given ‘conditional approval'.
Danish: Der er udstedt en “betinget godkendelse” for Sirturo.
English: Why is Sirturo approved?
Danish: Hvorfor er Sirturo blevet godkendt?
English: Sirturo is a tuberculosis medicine that contains the active substance bedaquiline.
Danish: Sirturo er et lægemiddel mod tuberkulose og indeholder det aktive stof bedaquilin.
English: What is Sirturo and what is it used for?
Danish: Hvad er Sirturo, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Sirturo.
Danish: Det er ikke en praktisk vejledning i, hvordan Sirturo bør anvendes.
English: What information is still awaited for Sirturo?
Danish: Hvilke oplysninger afventes der stadig for Sirturo?
English: Sirturo is used in combination with other tuberculosis medicines in adults with tuberculosis that is affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, two standard tuberculosis medicines).
Danish: Sirturo anvendes hos voksne med lungetuberkulose, der er multiresistent (resistent i det mindste over for isoniazid og rifampicin, som er to almindeligt anvendte lægemidler mod tuberkulose).
English: What are the risks associated with Sirturo?
Danish: Hvilke risici er der forbundet med Sirturo?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sirturo, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Sirturo er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: In a main study in adults with multi-drug resistant tuberculosis affecting the lung, Sirturo was compared with placebo (a dummy treatment) when added to combination treatment with other standard tuberculosis medicines.
Danish: I en hovedundersøgelse hos voksne med multiresistent lungetuberkulose blev Sirturo sammenlignet med placebo (virkningsløs behandling) ved anvendelse som tillægsbehandling til andre sædvanlige tuberkuloselægemidler.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sirturo on 05/03/2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sirturo den <dato for udstedelse af markedsføringstilladelse>.
English: For the full list of all side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Sirturo fremgår af indlægssedlen.
English: The average time it took to clear the bacteria from the sputum was also shorter for patients in the Sirturo group than for those in the placebo group (83 days versus 125 days).
Danish: Den gennemsnitlige tid, der gik, før den ophostede slim var fri for bakterier, var ligeledes kortere med Sirturo end med placebo (83 dage, sammenholdt med 125 dage).
English: The active substance in Sirturo, bedaquiline, works by specifically blocking an enzyme inside the M. tuberculosis bacteria called ATP synthase, which the bacteria need to generate energy.
Danish: Det aktive stof i Sirturo, bedaquilin, virker ved specifikt at blokere enzymet ATP-syntetase inde i M. tuberculosis-bakterien.
English: Cross-resistance is when bacteria develop resistance to a medicine after being exposed to another one, which is often the case with multi-drug resistant tuberculosis.
Danish: Krydsresistens vil sige, at bakterierne udvikler resistens mod ét lægemiddel efter at have været udsat for et andet.
English: For practical information about using Sirturo, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Sirturo, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Sirturo used?
Danish: Hvordan anvendes Sirturo?
English: Sirturo can only be obtained with a prescription.
Danish: udleveres kun efter recept.
English: How does Sirturo work?
Danish: Hvordan virker Sirturo ?
English: What benefits of Sirturo have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Sirturo?
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants /marketing authorisation holders in the Member States
Danish: Liste over lægemidlernes navne, lægemiddelformer, styrker, administrationsveje, ansøgere/indehavere af markedsføringstilladelser i medlemsstaterne.
English: Marketing authorisation holder
Danish: Indehaver af markedsføringstilladelsen
English: Route of administration
Danish: Styrke Lægemiddelform Administrationsvej
English: Mifepristone Linepharma 200 mg tablet
Danish: Mifepristone 200 mg tablet
English: This summary was last updated in 10-2018.
Danish: Dette sammendrag blev sidst ajourført i 10-2018.
English: Elocta received a marketing authorisation valid throughout the EU on 19 November 2015.
Danish: Elocta fik en markedsføringstilladelse med gyldighed i hele EU den 19. november 2015.
English: Further information on Elocta can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Elocta.
Danish: Yderligere information om Elocta findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Elocta.
English: Other information about Elocta
Danish: Andre oplysninger om Elocta
English: The injection is given into a vein over several minutes.
Danish: Indsprøjtningen gives i en blodåre over nogle minutter.
English: As for all medicines, data on the use of Elocta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Elocta løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Elocta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Elocta?
English: The European Medicines Agency therefore decided that Elocta's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Elocta opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Elocta and why it is authorised in the EU
Danish: En oversigt over Elocta, og hvorfor det er godkendt i EU
English: For more information about using Elocta, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Elocta, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Elocta are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Elocta vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The active substance in Elocta, efmoroctocog alfa, works in the body in the same way as human factor VIII.
Danish: Det aktive stof i Elocta, efmoroctocog alfa, virker på samme måde i kroppen som den menneskelige faktor XIII.
English: It contains the active substance efmoroctocog alfa.
Danish: Det indeholder det aktive stof efmoroctocog alfa.
English: What is Elocta and what is it used for?
Danish: Hvad er Elocta, og hvad anvendes det til?
English: What are the risks associated with Elocta?
Danish: Hvilke risici er der forbundet med Elocta?
English: Two main studies of Elocta showed that the medicine is effective at both preventing and treating bleeding episodes.
Danish: To hovedstudier med Elocta viste, at lægemidlet er effektivt både til at forebygge og behandle blødningsepisoder.
English: Why is Elocta authorised in the EU?
Danish: Hvorfor blev Elocta godkendt i EU?
English: In a study of 165 adult patients with haemophilia A, patients who were given Elocta as a tailored preventive treatment had around 3 bleeding episodes a year, which compares with 37 episodes a year in patients not given preventive treatment.
Danish: I en undersøgelse med 165 voksne patienter med hæmofili A havde de patienter, der fik Elocta som en tilpasset forebyggende behandling, ca. tre blødningsepisoder om året sammenholdt med 37 episoder om året for patienter, der ikke fik forebyggende behandling.
English: Hypersensitivity (allergic) reactions are seen rarely with Elocta and these include: swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the injection site, chills, flushing, itching over the whole body, headache, low blood pressure, lethargy, nausea, restlessness, and a fast heartbeat.
Danish: Disse omfatter: hævelse af ansigtet, udslæt, nældefeber, sammensnørende fornemmelse i brystet og vejrtrækningsbesvær, brændende og stikkende fornemmelse på indsprøjtningsstedet, kulderystelser, rødmen, kløe over hele kroppen, hovedpine, lavt blodtryk, sløvhed, kvalme, rastløshed og hurtig hjerterytme.
English: Elocta can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.
Danish: Elocta udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af hæmofili.
English: The dose and frequency of the injections depend on whether Elocta is used to treat or prevent bleeding, the severity of the patient's factor VIII deficiency, the extent and location of the bleeding and the patient's condition and bodyweight.
Danish: Dosis og hyppighed af indsprøjtningerne afhænger af, om Elocta skal anvendes til behandling eller forebyggelse af blødning, og desuden af, hvor alvorlig patientens mangel på faktor VIII er, blødningsomfang og -sted og patientens tilstand og legemsvægt.
English: Studies show that Elocta is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is in line with what is expected for medicines of its kind.
Danish: Studierne viser, at Elocta er effektivt til at forebygge og behandle blødningsepisoder hos patienter med hæmofili A, og at dets sikkerhed er på linje med, hvad der kan forventes for lægemidler af denne type.
English: In a study in 69 children, Elocta was similarly effective: 2 bleeding episodes occurred per year on average and 81% of bleeding episodes resolved with only one injection.
Danish: I en undersøgelse hos 69 børn var Elocta tilsvarende effektivt: Der indtrådte i gennemsnit to blødningsepisoder årligt, og 81 % af blødningsepisoderne blev afhjulpet med kun én indsprøjtning.
English: It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of bleeding.
Danish: Det erstatter den manglende faktor VIII og medvirker derfor til, at blodet størkner, så der opnås midlertidig kontrol med blødningen.
English: In addition, when bleeding did occur, Elocta treatment was rated as ‘excellent' or ‘good' in more than 78% of cases, with 87% of bleeding episodes resolving with only one injection.
Danish: behandlingen med Elocta bedømt som "udmærket" eller "god" i over 78 % af tilfældene, og 87 % af blødningsepisoderne blev afhjulpet med kun én indsprøjtning.
English: For the full list of side effects and restrictions of Elocta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Elocta fremgår af indlægssedlen.
English: There is also a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Danish: Der er desuden den risiko ved faktor VIII-lægemidler, at visse patienter danner antistoffer mod faktor VIII, hvilket medfører, at lægemidlet ikke længere virker, og kontrollen med blødning derfor svigter.
English: Elocta is available as a powder and solvent used to make a solution for injection.
Danish: Elocta fås som et pulver og solvens, der bruges til at fremstille en opløsning, der gives som indsprøjtning.
English: Elocta is a medicine used to treat and prevent bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Danish: Elocta er et lægemiddel til behandling og forebyggelse af blødning ved den arvelige blødningsforstyrrelse hæmofili A, som skyldes mangel på faktor VIII.
English: What benefits of Elocta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Elocta?
English: How is Elocta used?
Danish: Hvordan anvendes Elocta?
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Danish: Patienter med hæmofili A mangler faktor VIII, der er et protein, som er nødvendigt, for at blodet kan størkne normalt, og de har derfor en øget tendens til blødning.
English: How does Elocta work?
Danish: Hvordan virker Elocta?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elocta have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Elocta.
English: The Member States shall ensure that the Marketing Authorisation Holder complies with the following requirements in their Member State:
Danish: Medlemsstaten skal sikre at indehaveren af markedsføringstilladelsen opfylder følgende krav i deres medlemsstat:
English: • That liver function tests should be performed prior and during treatment.
Danish: • At leverfunktionstest skal udføres før og under behandling.
English: The MULTAQ Information Card should contain the following key safety messages:
Danish: MULTAQ-informationskortet skal indeholde følgende sikkerhedsmæssige hovedbudskaber:
English: The content and format of the MULTAQ Information Card, together with the communication and distribution plan should be agreed with the National Competent Authority in each Member State prior to distribution.
Danish: Indholdet og formatet af MULTAQ-informationskortet samt kommunikations- og distributionsplanen skal godkendes af den relevante nationale myndighed i hver medlemsstat før distribution.
English: • That plasma creatinine levels may rise initially due to inhibition of the renal tubular excretion of creatinine and are not necessarily indicative of a deterioration in renal function.
Danish: • At plasmakreatinin-niveauet kan stige initialt pga. hæmning af den renale tubulære udskillelse af kreatinin, og at dette ikke nødvendigvis er tegn på forværring af nyrefunktionen.
English: • That the use of MULTAQ is not recommended in patients with recent (1-3 months) stable NYHA class III heart failure or with LVEF <35%.
Danish: • At anvendelse af MULTAQ ikke anbefales hos patienter med nylig (1 til 3 måneder) stabil NYHA klasse III hjerteinsufficiens eller med LVEF < 35 %
English: o Class I or Class III antiarrhythmics.
Danish: • klasse I- og III-antiarymika.
English: The MULTAQ Information Card should contain a list of drugs which interact with MULTAQ classified according to the seriousness of the interaction (eg contraindication, not recommended, use with caution).
Danish: MULTAQ-informationskortet skal indeholde en liste over lægemidler, der interagerer med MULTAQ klassificeret efter sværhedsgraden af interaktionen (f.eks. kontraindikation, ikke anbefalet, anvendes med forsigtighed).
English: The Marketing Authorisation Holder shall ensure that Health care professionals who intend to prescribe or dispense MULTAQ are provided with an SPCand the MULTAQ Information Card.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at læger, som vil ordinere eller udlevere MULTAQ, får et produktresumé og MULTAQ-informationskortet.