FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Clopidogrel TAD, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel TAD, clopidogrel, er en hæmmer af trombocytaggregation.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel TAD 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 Clopidogrel TAD.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel TAD is used together with aspirin, the dose of which should not be higher than 100 mg.
Danish: Ved akut koronarsyndrom og atrieflimren anvendes Clopidogrel TAD sammen med aspirin.
English: How has Clopidogrel TAD been studied?
Danish: Hvordan blev Clopidogrel TAD undersøgt?
English: How is Clopidogrel TAD used?
Danish: Hvordan anvendes Clopidogrel TAD?
English: How does Clopidogrel TAD work?
Danish: Hvordan virker Clopidogrel TAD?
English: This summary was last updated in 11-2017.
Danish: Dette sammendrag blev sidst ajourført i 11-2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Spinraza on 30 May 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Spinraza den 30. maj 2017.
English: The first dose should be followed by 3 more doses after 2, 4, and 9 weeks and then one dose every 4 months thereafter.
Danish: Den første dosis skal efterfølges af 3 yderligere doser efter 2, 4 og 9 uger og derefter én dosis hver 4. måned.
English: This replaces the missing protein, thereby relieving the symptoms of the disease.
Danish: Det erstatter det manglende protein og mindsker derved symptomerne på sygdommen.
English: In babies some side effects could not be assessed, as they could not communicate them.
Danish: Hos spædbørn kunne nogle bivirkninger ikke vurderes, da de ikke kunne give udtryk for dem.
English: In its assessment, the European Medicines Agency recognised the serious nature of the disease and the urgent need for effective treatments.
Danish: I sin vurdering erkendte Det Europæiske Lægemiddelagentur sygdommens alvorlige karakter og det tvingende behov for effektiv behandling.
English: This is a summary of the European public assessment report (EPAR) for Spinraza.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Spinraza.
English: Although the medicine was not tested in patients with the most severe and the mildest forms of SMA, it is expected to provide similar benefits to these patients.
Danish: Lægemidlet blev ikke afprøvet hos patienter med hverken de sværeste eller de letteste former for SMA, men forventes at give tilsvarende fordele for sådanne patienter.
English: Spinraza contains the active substance nusinersen.
Danish: Spinraza indeholder det aktive stof nusinersen.
English: The recommended dose is 12 mg (one vial), given as soon as possible after the patient has been diagnosed with SMA.
Danish: Den anbefalede dosis er 12 mg (ét hætteglas), hurtigst muligt efter at patienten har fået stillet diagnosen SMA.
English: The Agency therefore decided that Spinraza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Spinraza opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The disease is linked to a defect on chromosome 5q and symptoms usually start shortly after birth.
Danish: Sygdommen skyldes en fejl i kromosom 5q, og symptomerne begynder normalt kort efter fødslen.
English: Because the number of patients with SMA is low, the disease is considered ‘rare', and Spinraza was designated an ‘orphan medicine' (a medicine used in rare diseases) on 2 April 2012.
Danish: Da antallet af patienter med SMA er lavt, betragtes sygdommen som "sjælden", og Spinraza blev udpeget som "lægemiddel til sjældne sygdomme" den 2. april 2012.
English: What measures are being taken to ensure the safe and effective use of Spinraza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Spinraza?
English: It is given by intrathecal injection (into the lower back, directly into the spine) by a doctor or nurse experienced in carrying out this procedure.
Danish: Det gives ved indsprøjtning nederst på ryggen direkte i rygsøjlen (intratekal injektion) af en læge eller sygeplejerske med erfaring i at udføre denne procedure.
English: Other information about Spinraza
Danish: Andre oplysninger om Spinraza
English: Spinraza can only be obtained with a prescription and treatment should be started by a doctor with experience in the treatment of SMA.
Danish: Spinraza udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af SMA.
English: The company that markets Spinraza will complete ongoing studies of the long-term safety and effectiveness of the medicine in patients who are showing symptoms of SMA and patients not yet showing symptoms.
Danish: Virksomheden, der markedsfører Spinraza, vil fuldføre igangværende undersøgelser af lægemidlets langsigtede sikkerhed og virkning hos patienter med symptomer på SMA og patienter, der endnu er symptomfrie.
English: The full EPAR for Spinraza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Spinraza findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After one year of treatment, 51% of babies receiving Spinraza (37 out of 73) showed progress in developing head control, rolling, sitting, crawling, standing and walking, whereas no similar progress was seen in any of the babies who received placebo.
Danish: Efter ét års behandling udviste 51 % af de spædbørn, der fik Spinraza (37 ud af 73), fremskridt med hensyn til at kontrollere hovedet, rulle, sidde, kravle, stå og gå, hvorimod der ikke var de samme fremskridt hos nogen af de spædbørn, der fik placebo.
English: Spinraza has been shown to lead to clinically meaningful improvements in young children with varying degrees of disease severity.
Danish: Det er påvist, at Spinraza fører til klinisk betydningsfuld bedring hos små børn med forskellige sværhedsgrader af sygdommen.
English: In addition, most babies treated with Spinraza survived for longer and needed breathing support later than those given placebo.
Danish: De fleste spædbørn, som blev behandlet med Spinraza, overlevede desuden længere og klarede sig længere uden åndedrætsstøtte end dem, der fik placebo.
English: One main study, involving 121 babies (of an average age of 7 months) with SMA, showed that Spinraza is effective in improving movement when compared with placebo (sham injection).
Danish: Én hovedundersøgelse, der omfattede 121 spædbørn (med en gennemsnitsalder på 7 måneder) med SMA, viste, at Spinraza er effektivt til at forbedre motorikken sammenlignet med placebo (skininjektion).
English: These side effects are thought to be caused by the injections into the spine used to give the medicine.
Danish: Bivirkningerne antages at skyldes de injektioner i rygraden, som anvendes til at give lægemidlet.
English: The most common side effects with Spinraza (which may affect more than 1 in 10 people) are headache, back pain and vomiting.
Danish: De hyppigste bivirkninger ved Spinraza (som optræder hos mere end 1 ud af 10 patienter) er hovedpine, rygsmerter og opkastning.
English: It is not intended to provide practical advice on how to use Spinraza.
Danish: Det er ikke en praktisk vejledning i, hvordan Spinraza bør anvendes.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Spinraza 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 Spinraza findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Side effects were considered manageable, with most side effects related to the way the medicine is given.
Danish: Bivirkningerne blev anset for at kunne håndteres, da de for størstedelen skyldes den måde medicinen gives på.
English: Another study assessed Spinraza's effectiveness in children whose SMA was less severe and diagnosed at a later stage (average age of 3 years).
Danish: I en anden undersøgelse vurderedes Spinrazas virkning hos børn med mindre svær SMA, som var diagnosticeret senere (gennemsnitsalder 3 år).
English: After 15 months of treatment, 57% of children receiving Spinraza showed improvement in movement compared with 26% of children on placebo.
Danish: Efter 15 måneders behandling sås der hos 57 % af de børn, der fik Spinraza, forbedret motorik sammenlignet med 26 % af de børn, der fik placebo.
English: Why is Spinraza approved?
Danish: Hvorfor blev Spinraza godkendt?
English: For more information about treatment with Spinraza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Spinraza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is Spinraza and what is it used for?
Danish: Hvad er Spinraza, og hvad anvendes det til?
English: For the full list of all side effects and restrictions with Spinraza, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Spinraza fremgår af indlægssedlen.
English: The SMN protein is made from two genes, SMN1 and SMN2.
Danish: Til dannelsen af SMN-proteinet medvirker to gener, SMN1 og SMN2.
English: Spinraza is a medicine used to treat 5q spinal muscular atrophy (SMA), a genetic disease that causes weakness and wasting of the muscles including the lung muscles.
Danish: Spinraza er et lægemiddel, der anvendes til behandling den genetiske sygdom 5q spinal muskelatrofi (SMA), der forårsager svaghed og svind af musklerne, herunder vejrtrækningsmusklerne.
English: Patients with SMA lack the SMN1 gene but have the SMN2 gene, which mostly produces a short SMN protein that does not work as well as a full-length protein.
Danish: Patienter med SMA mangler SMN1-genet, men har SMN2-genet, der som regel producerer et kort SMN-protein, som ikke virker lige så godt som et protein i fuld længde.
English: Spinraza is a synthetic anti-sense oligonucleotide (a type of genetic material) that enables the SMN2 gene to produce full length protein, which is able to work normally.
Danish: Spinraza er et syntetisk antisense-oligonukleotid (en art genetisk materiale), som gør det muligt for SMN2-genet at producere et protein i fuld længde, der virker normalt.
English: Treatment should be continued for as long as the patient benefits from it. For further information, see the package leaflet.
Danish: Behandlingen bør fortsættes, så længe det er til fordel for patienten.
English: What are the risks associated with Spinraza?
Danish: Hvilke risici er der forbundet med Spinraza?
English: Patients with SMA lack a protein called ‘survival motor neuron' (SMN) protein, which is essential for motor neurons (nerve cells from the spinal cord that control muscle movements) to survive and function normally.
Danish: Patienter med SMA mangler "survival motor neuron" (SMN)-proteinet, som er afgørende for, at de nerveceller fra rygmarven, der styrer muskelbevægelserne (de motoriske neuroner), kan overleve og fungere normalt.
English: The medicine is available as a solution for injection in 12 mg vials.
Danish: Lægemidlet fås som injektionsvæske, opløsning, i 12-mg-hætteglas.
English: For practical information about using Spinraza, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Spinraza, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spinraza have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Spinraza.
English: How is Spinraza used?
Danish: Hvordan anvendes Spinraza?
English: What benefits of Spinraza have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Spinraza?
English: How does Spinraza work?
Danish: Hvordan virker Spinraza?
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administrat ion
English: Side effects may occur up to 4 months or more after the last Hyrimoz injection.
Danish: Bivirkninger kan forekomme op til 4 måneder eller mere efter den sidste Hyrimoz-injektion.
English: The decision to stop using Hyrimoz should be discussed with your doctor.
Danish: Beslutningen om at stoppe med at bruge Hyrimoz skal diskuteres med din læge.
English: • On rare occasions, treatment with Hyrimoz could result in lupus-like syndrome.
Danish: • I sjældne tilfælde kan behandling med Hyrimoz resultere i lupus-lignende syndrom.
English: The potential risk with the combination of azathioprine or 6mercaptopurine and Hyrimoz should be carefully considered.
Danish: Den potentielle risiko ved kombination af azathioprin eller 6-mercaptopurin og Hyrimoz bør nøje overvejes.
English: Keep this Patient Reminder Card with you during your treatment and for 4 months after your (or your child's) last injection of Hyrimoz.
Danish: Opbevar patientkortet på dig under din behandling og i 4 måneder efter din (eller dit barns) sidste injektion af Hyrimoz.
English: You and your doctor should pay special attention to signs of infection while you are being treated with Hyrimoz.
Danish: Du og din læge bør være særligt opmærksomme på tegn på infektion mens du er i behandling med Hyrimoz.
English: • If you are over 65 years you may be more susceptible to infections while taking Hyrimoz.
Danish: • Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager Hyrimoz.
English: Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for use”.
Danish: Detaljeret vejledning om, hvordan Hyrimoz injiceres, gives i punkt 7 ”Brugsvejledning”.
English: You should continue to inject Hyrimoz for as long as your doctor has told you.
Danish: Du skal fortsætte med at injicere Hyrimoz så længe, din læge har fortalt dig.
English: If you have any questions, please talk to a doctor, pharmacist or nurse who is familiar with Hyrimoz.
Danish: Hvis du har nogen spørgsmål, så tal med en læge, apotekspersonalet eller en sygeplejerske, som kender Hyrimoz.
English: Hyrimoz in combination with methotrexate, is indicated for:
Danish: Hyrimoz i kombination med methotrexat er indiceret til:
English: Hyrimoz can also be given alone.
Danish: Hyrimoz kan også anvendes alene.
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Hyrimoz.
Danish: • Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med adalimumab, vil lægen undersøge dig for tegn og symptomer på tuberkulose, før behandling med Hyrimoz påbegyndes.
English: • that Hyrimoz treatment may increase the potential risks of o infections, including tuberculosis o cancer o nervous system problems o vaccinations
Danish: • at behandling med Hyrimoz kan øge de mulige risici for o infektioner, inklusive tuberkulose o cancer o problemer med nervesystemet o vaccinationer
English: - Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before you are given Hyrimoz and during treatment with Hyrimoz.
Danish: - Din læge vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under din behandling med Hyrimoz.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Hyrimoz.
Danish: Patienter skal derfor monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med Hyrimoz.
English: Patients on Hyrimoz may receive concurrent vaccinations, except for live vaccines.
Danish: Patienter i Hyrimoz-behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner.
English: If you take Hyrimoz the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når du tager Hyrimoz, kan risikoen for at få et lymfom, leukæmi eller andre former for kræft øges.
English: • Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Hyrimoz in case they cause infections.
Danish: • Visse vacciner indeholder levende men svækkede former for sygdomsfremkaldende bakterier eller virusser og bør ikke gives under Hyrimoz-behandling i tilfælde af, at de giver infektioner.
English: If you have mild heart failure and you are being treated with Hyrimoz, your heart failure status must be closely monitored by your doctor.
Danish: Hvis du har lettere hjerteinsufficiens og bliver behandlet med Hyrimoz, skal status for din hjerteinsufficiens følges nøje af din læge.
English: Treatment with Hyrimoz may result in the formation of autoimmune antibodies.
Danish: Behandling med Hyrimoz kan medføre dannelse af autoimmune antistoffer.
English: Hyrimoz should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Hyrimoz bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II).
English: • inject Hyrimoz 15-30 minutes after taking it out of the refrigerator for a more comfortable injection.
Danish: • injicer Hyrimoz 15-30 minutter efter, at du har taget det ud af køleskabet for at få en mere behagelig injektion.
English: By attaching to TNFα, Hyrimoz blocks its action and reduces the inflammation in these diseases.
Danish: Ved at binde sig til TNFα blokerer Hyrimoz dennes virkning og reducerer den inflammatoriske proces i disse sygdomme.
English: Your doctor may recommend temporarily stopping Hyrimoz.
Danish: Din læge kan anbefale midlertidig afbrydelse af Hyrimoz.
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Hyrimoz treatment.
Danish: • Du bør overveje brugen af passende prævention for at forhindre graviditet og fortsætte brugen mindst 5 måneder efter den sidste behandling med Hyrimoz.
English: After proper training in injection technique, patients may self-inject with Hyrimoz if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Efter passende oplæring i injektionsteknik kan patienter selv injicere Hyrimoz, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Hyrimoz and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.
Danish: • Hvis du får allergiske reaktioner med symptomer som trykken for brystet, hvæsende vejrtrækning, svimmelhed, hævelser eller udslæt, så undlad at injicere mere Hyrimoz, og kontakt straks lægen, da disse reaktioner i sjældne tilfælde kan være livstruende.
English: Before initiation of therapy with Hyrimoz, all patients must be evaluated for both active and inactive (“latent”) tuberculosis infection.
Danish: Før behandling med Hyrimoz påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: A single Hyrimoz pre-filled syringe / pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: En enkelt Hyrimoz fyldt injektionssprøjte/fyldt pen kan opbevares ved temperaturer på op til maksimalt 25°C i en periode på op til 14 dage.
English: If you receive Hyrimoz while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Danish: Hvis du har fået Hyrimoz, mens du var gravid, kan dit spædbarn have en højere risiko for at få en sådan infektion i op til ca. fem måneder efter din sidste dosis under graviditeten.
English: The impact of long-term treatment with adalimumab on the development of autoimmune diseases is unknown.
Danish: Det vides ikke, hvilken virkning langtidsbehandling med adalimumab har på udviklingen af autoimmune sygdomme.
English: Administration of Hyrimoz should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Danish: Administration af Hyrimoz bør ophøre, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling iværksættes, indtil infektionen er under kontrol.
English: • It is important that you tell your baby's doctors and other health care professionals about your Hyrimoz use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
Danish: • Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner om din brug af Hyrimoz under graviditeten, før dit barn får nogen vaccinationer (for mere information om vacciner, se afsnittet vedrørende "Advarsler og forsigtighedsregler").
English: Carriers of HBV who require treatment with Hyrimoz should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Bærere af HBV, som kræver behandling med Hyrimoz, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
English: Treatment with Hyrimoz should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Danish: Behandling med Hyrimoz bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Danish: Aktiv tuberkulose eller andre alvorlige infektioner, såsom sepsis og opportunistiske infektioner (se pkt.
English: Hyrimoz works by reducing this inflammation.
Danish: Hyrimoz virker ved at reducere denne inflammation.
English: Taking these results into consideration, Hyrimoz is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Danish: I betragtning af disse resultater anbefales Hyrimoz til anvendelse i kombination med MTX og til anvendelse som monoterapi til patienter, som ikke egner sig til behandling med MTX (se afsnit 4.2).
English: Treatment with Hyrimoz can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Danish: Behandling med Hyrimoz kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler.
English: Treatment with Hyrimoz must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med Hyrimoz skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
English: Patients who develop a new infection while undergoing treatment with Hyrimoz should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, der udvikler en ny infektion under behandling med Hyrimoz, bør monitoreres nøje og gennemgå en fuldstændig diagnostisk evaluering.