FrancophonIA/ELRC3.0 huggingface dataset:
English: Lot:
Danish: Lotnummer:
English: Method of administration
Danish: Forberedelsesmetode
English: Pallor
Danish: Blære
English: Kidneys
Danish: Bleghed
English: In vivo, flutemetamol (18F)
Danish: Efter 36 måneder var følsomheden af flutemetamol (18F)
English: In a re-reading study that increased the patient population of the pivotal study to include 38 additional autopsied patients (i.e., 106 in total), sensitivity and specificity for detection of moderate-frequent βamyloid neuritic plaque density in the primary analysis were 91% (95% CI: 82% to 96%) and 90% (95% CI: 74% to 98%), respectively, based on the majority read (i.e., the image interpretation reached by at least 3 of the 5 readers after electronic training).
Danish: Sensitivitet og specificitet for påvisning af moderat / hyppigt forekommende β-amyloid neuritisk plaktæthed i den primære analyse var henholdsvis 91% (95% CI: 82% til 96%) og 90% (95% CI: 74% til 98%).
English: Sodium dihydrogen phosphate dihydrate Disodium hydrogen phosphate dodecahydrate Water for injections
Danish: Natriumdihydrogenfosfatdihydrat
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the images obtained from the brain scan.
Danish: Brug af anden medicin sammen med VIZAMYL Fortæl din nuklearmedicinske læge, hvis du tager anden medicin eller har gjort det for nylig.
English: Vomiting
Danish: Livmoder
English: Pancreas
Danish: Galdeblære
English: What is Onpattro and what is it used for?
Danish: Hvad er Onpattro, og hvad anvendes det til?
English: The recommended dose is 300 micrograms per kilogram body weight once every 3 weeks.
Danish: Den anbefalede dosis er 300 mikrogram/kg legemsvægt, der indgives 1 gang hver 3. uge.
English: As for all medicines, data on the use of Onpattro are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Onpattro løbende overvåget.
English: Other information about Onpattro
Danish: Andre oplysninger om Onpattro
English: Onpattro contains the active substance patisiran.
Danish: Onpattro indeholder det aktive stof patisiran.
English: What measures are being taken to ensure the safe and effective use of Onpattro?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Onpattro?
English: The European Medicines Agency therefore decided that Onpattro'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 Onpattro opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Why is Onpattro authorised in the EU?
Danish: Hvorfor er Onpattro godkendt i EU?
English: An overview of Onpattro and why it is authorised in the EU
Danish: En oversigt over Onpattro, og hvorfor det er godkendt i EU
English: The most common side effects with Onpattro (which may affect more than 1 in 10 people) are peripheral oedema (swelling, especially of the ankles and feet) and infusion-related reactions including pain, nausea (feeling sick), headache, tiredness, dizziness, cough and breathing problems, reddening of the skin, rapid heartbeat, low or high blood pressure and swelling of the face.
Danish: De hyppigste bivirkninger ved Onpattro (der kan forekomme hos mere end 1 ud af 10 patienter) er perifert ødem (hævelse, navnlig i ankler og fødder) og infusionsrelaterede reaktioner, herunder smerter, kvalme, hovedpine, træthed, svimmelhed, hoste og vejrtrækningsproblemer, hudrødme, hurtig hjerterytme, lavt eller højt blodtryk og hævelse i ansigtet.
English: Further information on Onpattro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Onpattro findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Onpattro may be given at home by a healthcare professional if the patient has had at least 3 infusions given in hospital without problems.
Danish: Onpattro kan indgives hjemme af en sundhedsperson, hvis patienten har fået mindst 3 infusioner på hospitalet uden problemer.
English: For more information about using Onpattro, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Onpattro, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Regarding safety, the most serious side effects are infusion-related reactions and these can be managed with premedication and changes to infusion speed.
Danish: Hvad angår sikkerheden, er de alvorligste bivirkninger infusionsrelaterede reaktioner, og de kan håndteres ved præmedicinering og justering af infusionshastigheden.
English: Side effects reported with Onpattro are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger indberettet for Onpattro vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: hATTR amyloidosis is rare, and Onpattro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 April 2011.
Danish: hATTR-amyloidose er sjælden, og Onpattro blev udpeget som "lægemiddel til sjældne sygdomme" den 15.april 2011.
English: Onpattro can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of patients with amyloidosis.
Danish: Onpattro udleveres kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af patienter med amyloidose.
English: To reduce the risk of infusion-related reactions, patients should be given corticosteroid medicines, paracetamol and medicines known as H1 and H2 blockers before receiving Onpattro.
Danish: For at reducere risikoen for infusionsrelaterede reaktioner bør patienterne have kortikosteroider, paracetamol og såkaldte H1- og H2-blokkere, inden de får Onpattro.
English: Patients should also take vitamin A supplements during treatment with Onpattro.
Danish: Patienterne bør også tage tilskud af A-vitamin under behandling med Onpattro.
English: The active substance in Onpattro, patisiran, is a ‘small interfering RNA' (siRNA), a very short piece of synthetic genetic material that has been designed to attach to and block the genetic material of the cell responsible for producing transthyretin.
Danish: Det aktive stof i Onpattro, patisiran, er såkaldt "small interfering RNA" (siRNA), som er et meget kort stykke genetisk materiale, der er designet til at binde til og blokere det genetiske materiale for den celle, der danner transthyretin.
English: What are the risks associated with Onpattro?
Danish: Hvilke risici er der forbundet med Onpattro?
English: The company that markets Onpattro will provide educational materials for doctors and patients with information about how to give the medicine safely when at home and how to manage side effects.
Danish: Den virksomhed, der markedsfører Onpattro, skal sørge for informationsmateriale til læger og patienter med oplysning om, hvordan lægemidlet indgives sikkert i hjemmet, og om, hvordan bivirkninger håndteres.
English: The broken protein forms amyloid deposits in tissues and organs around the body, including around nerves, where it interferes with their normal functions.
Danish: Det ødelagte protein danner amyloid, som deponeres i væv og organer rundt om i kroppen, herunder også rundt om nerverne, hvor det forstyrrer deres normale funktion.
English: This reduces production of defective transthyretin, thereby reducing the formation of amyloids and relieving the symptoms of hATTR amyloidosis.
Danish: Dermed reduceres dannelsen af defekt transthyretin, hvilket reducerer dannelsen af amyloider og lindrer symptomerne på HATTR-amyloidose.
English: After 18 months of treatment, the mNIS+7 score decreased on average by 6 points with Onpattro (from around 81 to around 75 points), indicating a slight improvement of the patients' condition.
Danish: Efter 18 måneders behandling faldt mNIS+7-scoren i gennemsnit med 6 point ved brug af Onpattro (fra ca. 81 til ca. 75 point), svarende til en let bedring i patienternes tilstand.
English: Onpattro is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient is able to walk unaided, and stage 2, when the patient can still walk but needs help).
Danish: Onpattro anvendes hos voksne patienter, der har nervebeskadigelse af grad 1 (patienten kan gå uden hjælp) og grad 2 (patienten kan stadig gå, men har brug for hjælp).
English: For the full list of side effects and restrictions with Onpattro, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Onpattro fremgår af indlægssedlen.
English: This compares with an increase on average by 28 points with placebo (from around 75 to around 101 points), indicating that nerve damage got worse in these patients.
Danish: Dette skal sammenholdes med en stigning med i gennemsnit 28 point ved brug af placebo (fra ca. 75 til ca. 101 point), svarende til en forværring af nervebeskadigelsen hos disse patienter.
English: In one main study involving 225 hATTR amyloidosis patients with stage 1 or 2 nerve damage, Onpattro was shown to be more effective than placebo (a dummy treatment) at slowing down the nerve damage caused by the disease.
Danish: I et hovedstudie, der omfattede 225 hATTR-patienter med grad 1- eller grad 2-nervebeskadigelse, blev det påvist, at Onpattro er mere effektivt end placebo (et ikke-aktivt stof) til at bremse den nervebeskadigelse, som sygdommen medfører.
English: How is Onpattro used?
Danish: Hvordan anvendes Onpattro?
English: In patients with hATTR amyloidosis, a protein called transthyretin which circulates in the blood is defective and breaks easily.
Danish: Hos patienter med hATTR-amyloidose er proteinet transthyretin, der cirkulerer rundt i blodet, defekt og nedbrydes hurtigt.
English: The main measure of effectiveness was the change in the patients' nerve damage, as measured using a standard scale called ‘mNIS+7', with scores ranging from 0 to 304 (a higher score indicates more severe nerve damage).
Danish: Det primære mål for virkning var ændringen i patienternes nervebeskadigelse i henhold til den såkaldte mNIS+7-standardskala med scorer fra 0-304 (jo højere score, desto sværere nervebeskadigelse).
English: Onpattro is a medicine used to treat nerve damage caused by hereditary transthyretin (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves.
Danish: Onpattro er et lægemiddel til behandling af beskadigelse af nerverne som følge af den arvelige sygdom transthyretin-amyloidose (hATTR-amyloidose), hvor et protein kaldet amyloid ophobes i vævene rundt om i kroppen, herunder rundt om nerverne.
English: The medicine is available as a solution for infusion (drip) into a vein.
Danish: Onpattro fås som en væske til infusion (drop) i en vene.
English: What benefits of Onpattro have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Onpattro?
English: How does Onpattro work?
Danish: Hvordan virker Onpattro?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onpattro 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 Onpattro.
English: Onpattro was shown to be effective at slowing down nerve damage in hATTR amyloidosis patients with stage 1 or stage 2 nerve damage; available data were not sufficient to assume a beneficial effect in stage 3 patients (those confined to a wheelchair).
Danish: Det er påvist, at Onpattro er effektivt til at bremse nervebeskadigelsen hos hATTR-amyloidosepatienter med nervebeskadigelse af grad 1 eller grad 2.
English: At the December plenary meeting, the CHMP adopted a LoQ centred on the following points:
Danish: På sit plenarmøde i december vedtog CHMP en LoQ, der var centreret om følgende punkter:
English: This is a very rare reaction, which can be serious if it occurs.
Danish: Det er en meget sjælden bivirkning, som kan være alvorlig, hvis den opstår.
English: This is one of the most common causes of heart disease.
Danish: Dette er en af de hyppigste årsager til hjertesygdom.
English: Treatment was initiated during the acute phase after hospital admission and lasted for a period of 16 weeks.
Danish: Behandling blev initieret under den akutte fase efter hospitalindlæggelse og varede i en periode på 16 uger.
English: Common: allergic reactions.
Danish: Almindelig: Allergiske reaktioner.
English: Atorvastatin was not carcinogenic in rats.
Danish: Atorvastatin var ikke karcinogent hos rotter.
English: Avoid drinking too much alcohol while taking this medicine.
Danish: De bør undgå at indtage for meget alkohol, når De tager denne medicin.
English: A therapeutic response is evident within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks.
Danish: Terapeutisk virkning ses allerede indenfor 2 uger, og maksimalt respons opnås normalt inden for 4 uger.
English: Overall conclusion on benefit/risk
Danish: Samlet konklusion vedrørende benefit/risk forhold
English: In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended.
Danish: I sådanne tilfælde bør risikoen ved behandlingen vurderes i forhold til mulig fordel, og klinisk monitorering anbefales.
English: Cholesterol is a naturally occurring substance in the body necessary for normal growth.
Danish: Kolesterol er et naturligt forekommende stof i kroppen, og som er nødvendig for normal vækst.
English: The safety and tolerability profiles of the two treatment groups were comparable.
Danish: Sikkerheds- og tolerabilitetsprofilen er sammenlignelig i de 2 grupper.
English: Do not take a double dose to make up for a forgotten dose.
Danish: De må ikke tage en dobbelt dosis som erstatning for en glemt dosis.
English: Do not take {PRODUCT NAME} if you are pregnant, if you think you may be pregnant, or if you are trying to become pregnant.
Danish: De må ikke tage {(Sær)navn}, hvis De er gravid, hvis De tror De er gravid, eller hvis De ønsker at blive gravid.
English: - The posology in Section 4.2 has been revised as follows:
Danish: - Doseringen i afsnit 4.2 er revideret som følger:
English: These increased concentrations should be considered when selecting oral contraceptive doses.
Danish: Disse forhøjede koncentrationer bør tages i betragtning, når dosis af orale antikonceptiva fastsættes.
English: - Section 5.1 has been updated to include the results of the ASCOT-LLA and CARDS trials as follows:
Danish: - Afsnit 5.1 er blevet ført ajour, så resultaterne af ASCOT-LLA- og CARDS-forsøgene indgår som følger:
English: Finally, there has been much discussion regarding the wording of the indication that best reflects the results of the of the assessed trials.
Danish: Endelig har der været megen drøftelse af, hvilken ordlyd, der bedst afspejler resultaterne af de vurderede kliniske forsøg.
English: Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of {PRODUCT}.
Danish: De bør ikke tage mere end 1-2 små glas grapefrugtjuice dagligt, da store mængder grapefrugtjuice kan påvirke virkningen af {(Sær)navn}.
English: Mortality and morbidity studies with atorvastatin have not yet completed.
Danish: Mortalitets- og morbiditets-studier med atorvastatin er endnu ikke afsluttede.
English: The appropriate place for dose recommendations is section 4.2 of the SPC, not section 4.1, and adequate dosing recommendations have been added.
Danish: Det mest hensigtsmæssige sted til anbefalinger for doseringen er i produktresuméets afsnit 4.2, ikke afsnit 4.1, og passende anbefalinger for dosering er tilføjet.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR ÆNDRING AF DET AF EMEA FORELAGTE PRODUKTRESUMÉ
English: Patients taking digoxin should be monitored appropriately.
Danish: Patienter i digoxinbehandling bør monitoreres omhyggeligt.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ATORVASTATIN (Sortis and associated names - see Annex I)
Danish: SAMMENFATNING AF DEN VIDENSKABELIGE EVALUERING AF ATORVASTATIN (Sortis og associerede navne - se bilag I)
English: • the CHMP, as a consequence, considered the benefit/risk balance for the above-mentioned extension of indication to be favourable,
Danish: • CHMP fandt derfor, at benefit/risk-forholdet er gunstigt for ovenstående udvidelse af indikationen,
English: Indeed, many of the patients were at low risk, particularly the females in ASCOT-LLA.
Danish: Det er korrekt, at mange af patienterne var i lavrisikogruppen, især kvinderne i ASCOT-LLA.
English: Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis.
Danish: Atorvastatin bør gives med forsigtighed til patienter med prædisponerede faktorer for rhabdomyolyse.
English: • the CHMP considered the referral made under article 6.12 of Commission Regulation (EC) No 1084/2003, for atorvastatin (Sortis and associated names - see Annex I),
Danish: • CHMP behandlede den indbringelse, der har fundet sted i henhold til artikel 6.12 af Kommissionens forordning (EF) nr. 1084/2003 for atorvastatin (Sortis og associerede navne - jf. bilag I)
English: Before the treatment
Danish: Før behandlingen
English: Sortis and associated names contain atorvastatin, a well-known HMG-CoA reductase inhibitor (statin), registered in the EU since 1996 through Mutual Recognition Procedure and national procedures.
Danish: Sortis og associerede navne indeholder atorvastatin, en velkendt HMG-CoA reduktasehæmmer (et statin), der har været registreret i EU siden 1996 gennem den gensidige anerkendelsesprocedure og nationale procedurer.
English: Clarithromycin increased the Cmax and AUC of atorvastatin by 56% and 80% respectively.
Danish: Clarithromycin forhøjede Cmax og AUC af atorvastatin med henholdsvis 56% og 80%.
English: The active substance of {PRODUCT NAME} is atorvastatin.
Danish: Det aktive indholdsstof i {(Sær)navn} er atorvastatin.
English: Apart from other pathways these products are further metabolized via glucuronidation.
Danish: Bortset fra andre omsætningsveje metaboliseres disse produkter yderligere via glucuronidering.
English: Increases and decreases in blood sugar levels have also been seen (If you have diabetes you should continue careful monitoring of your blood sugar levels).
Danish: Der er set højt eller lavt blodsukkerindhold (hvis De har diabetes, bør De omhyggeligt kontrollere Deres blodsukker).
English: A point of minor discussion was the applicability of the trial results to other strengths of atorvastatin.
Danish: Et punkt, der gav anledning til mindre drøftelse, var forsøgsresultaternes anvendelse på andre styrker af atorvastatin.
English: The CHMP agrees that there is no reason to believe that higher doses would have a lower effect than the 10mg dose in the approved indication, independently of individual target cholesterol levels, and the potentially different safety profile of higher dosages.
Danish: CHMP er enig i, at der ikke grund til at antage, at højere doser vil have ringere virkning end 10 mg doseringen til den godkendte indikation, uanset de individuelle mål for kolesteroltallet og den potentielt anderledes sikkerhedsprofil af højere dosering.
English: − Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever.
Danish: Patienter skal opfordres til omgående at rapportere muskelsmerter, kramper eller svaghed, især hvis disse er ledsaget af utilpashed eller feber.
English: Efficacy and safety in patients older than 70 using recommended doses is similar to that seen in the general population.
Danish: Effekt og sikkerhed af anbefalede doser til ældre patienter over 70 år svarer til det, som ses hos den almindelige befolkning.
English: {PRODUCT NAME} tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food.
Danish: {(Sær)navn} tabletter skal synkes hele med et glas vand, og kan tages på et hvilket som helst tidspunkt af døgnet med eller uden mad.
English: Less than 2% of patients were discontinued from clinical trials due to side effects attributed to {PRODUCT NAME}.
Danish: Mindre end 2% af patienterne udgik af kliniske studier på grund af bivirkninger forbundet med {(Sær)navn}.
English: The safety of atorvastatin in pregnancy and lactation has not yet been proven.
Danish: Sikkerheden ved anvendelse af atorvastatin under graviditet og amning er endnu ikke klarlagt.
English: Do not use any tools or machines if your ability to use them is affected by this medicine.
Danish: Brug ikke værktøj eller maskiner hvis Deres evne til at bruge disse er påvirket af denne medicin.
English: There is evidence from animal studies that HMG-CoA reductase inhibitors may influence the development of embryos or foetuses.
Danish: Dyreforsøg viser tegn på, at HMG-CoA-reduktasehæmmere kan påvirke udviklingen af embryo og foster.
English: The other secondary endpoints did not reach statistical significance on their own (overall: Placebo: 22.2%, Atorvastatin: 22.4%).
Danish: De øvrige sekundære endepunkter var ikke selvstændigt signifikante (samlet: placebo: 22,2%, atorvastatin: 22,4%).
English: Uncommon: tinnitus
Danish: Ikke almindelig: Tinnitus
English: These differences were of no clinical significance, resulting in no clinically significant differences in lipid effects among men and women.
Danish: Disse forskelle har ingen klinisk betydning og resulterer ikke i nogen klinisk signifikante forskelle i den lipidregulerende virkning mellem kønnene.
English: In this randomized, double- blind, multicenter, controlled clinical trial, IVUS was performed at baseline and at 18 months in 502 patients.
Danish: I dette randomiserede, dobbelt-blinde, multicenter, kontrollerede kliniske studie blev IVUS udført ved baseline og ved 18 måneder hos 502 patienter.
English: Moreover, the Applicant has provided an adequate and objective justification against a restriction to exclude women from the proposed indication given the current knowledge regarding the beneficial effects of statin treatment overall and also in women, including trial results, guidelines and international recommendations.
Danish: Desuden har ansøgeren forelagt en fyldestgørende og objektiv argumentation imod, at kvinder udelukkes fra den ansøgte indikation, baseret på den nuværende viden om de gavnlige virkninger af behandling med statiner generelt, også hos kvinder, og bestående af forsøgsresultater, guidelines og internationale anbefalinger.
English: 4.7 Effects on ability to drive and use machines {PRODUCT NAME} has negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner {(Sær)navn} har ubetydelig indflydelse på evnen til at føre bil eller betjene maskiner.
English: Liver function tests should be performed and serum CPK levels should be monitored.
Danish: Leverfunktionsmålinger og serum-CK-niveauet bør monitoreres.
English: Concomitant intake of large quantities of grapefruit juice and atorvastatin is therefore not recommended.
Danish: Det kan derfor ikke anbefales at indtage store mængder grapefrugtjuice og atorvastatin samtidigt.
English: The low systemic availability is attributed to presystemic clearance in gastrointestinal mucosa and/or hepatic first-pass metabolism
Danish: Den lave systemiske tilgængelighed skyldes præsystemisk clearance i gastrointestinal mucosa og/eller first-pass metabolisme i leveren.
English: 178 vs 247
Danish: 178 mod 247