FrancophonIA/ELRC3.0 huggingface dataset:
English: • Methadone is used to treat drug addiction in patients depending on opioids (such as heroin).
Danish: • Metadon bruges til behandling af stofafhængighed hos patienter, der er afhængige af opioider (såsom heroin).
English: The PRAC concluded that risk minimisation measures would be insufficient to mitigate the risks with oral solutions containing high molecular weight povidone, and therefore recommended that these products should be suspended.
Danish: PRAC konkluderede, at risikominimeringsforanstaltninger ikke ville kunne afbøde risiciene tilstrækkeligt ved orale opløsninger indeholdende højmolekylært povidon.
English: Because the CMDh reached an agreement by consensus, it will be implemented by the Member States where the medicines are authorised according to an agreed timetable.
Danish: Da CMD(h)'s standpunkt blev vedtaget med konsensus, vil det efter den vedtagne tidsplan blive gennemført i de medlemsstater, hvor lægemidlerne er godkendt.
English: • Some methadone oral solutions contain an additive, povidone.
Danish: • Visse orale metadonopløsninger indeholder hjælpestoffet povidon.
English: If a medicine containing high molecular weight povidone (known as K90) is misused in this way, the povidone is not excreted from the body and accumulates inside the cells of vital organs, which may cause serious harm.
Danish: Hvis et lægemiddel indeholdende højmolekylært povidon (kendt som K90) misbruges på denne måde, vil povidon ikke blive udskilt fra kroppen, men ophobes i cellerne i vitale organer, hvor det kan medføre alvorlig skade.
English: If methadone oral solutions containing high molecular weight povidone (K90) are misused by injection instead of being taken by mouth as they are intended, the povidone accumulates inside vital organs and may cause serious harm, with possible fatal consequences.
Danish: Hvis orale metadonopløsninger, der indeholder povidon med høj molekylvægt (K90), misbruges ved injektion i stedet for den tilsigtede indtagelse gennem munden, vil povidon blive ophobet i vitale organer, hvor det kan medføre alvorlige, og eventuelt dødbringende, skader.
English: The risk of harm is reduced with low molecular weight povidone (e.g. K25 and K30) as this type of povidone is excreted from the body and is not expected to accumulate inside the cells as high molecular weight povidone does.
Danish: Risikoen for skader mindskes med povidon med lavere molekylvægt (f.eks. K25 og K30), da denne type povidon udskilles fra kroppen og ikke forventes at ophobes i cellerne ligesom højmolekylært povidon.
English: For methadone tablets containing povidone of lower molecular weight (e.g. K25 and K30), the available data showed that this kind of povidone is excreted from the body and does not accumulate inside the cells as high molecular weight povidone does.
Danish: For metadontabletter, der indeholder povidon med lavere molekylvægt (f.eks. K25 og K30), viste de foreliggende data, at denne type povidon udskilles fra kroppen og ikke ophobes i cellerne ligesom højmolekylært povidon.
English: Povidone is used in oral solutions as a suspending and dispersing agent, or as a binding agent for tablets.
Danish: Povidon anvendes hovedsagelig som opslæmmende og dispergerende middel i orale opløsninger og som bindemiddel i tabletter.
English: • Some oral methadone solutions contain high molecular weight povidone (K90), which can be harmful if injected as it is retained in the body and may cause tissue damage.
Danish: • Visse orale metadonopløsninger indeholder højmolekylært povidon (K90), som ved injektion ophobes i kroppen og kan medføre vævsskade.
English: • Cases of povidone deposits and serious adverse reactions (e.g. anaemia and pathological fractures) have been reported in intravenous drug abusers.
Danish: • Hos stiknarkomaner er beskrevet aflejringer af povidon med alvorlige bivirkninger (f.eks. anæmi og patologiske frakturer).
English: The PRAC assessed the available safety data on the risks associated with the misuse by injection of methadone medicines containing povidone from post-marketing reports and the published literature, and a group of experts (which included pathologists and addiction experts) was consulted for advice.
Danish: PRAC vurderede risiciene ved misbrug gennem injektion af metadonlægemidler med povidon på grundlag af de foreliggende sikkerhedsdata fra indberetninger efter markedsføring og den publicerede litteratur.
English: The povidone contained in oral methadone solutions has a high molecular weight (known as K90), while the povidone used in methadone tablets has a low molecular weight (e.g. K25 and K30).
Danish: Det povidon, der anvendes i metadontabletter, har derimod lav molekylvægt (f.eks. K25 og K30).
English: Oral methadone medicines are available as solutions or tablets; only oral methadone products containing povidone were concerned by this review.
Danish: Denne gennemgang omfattede kun orale metadonlægemidler indeholdende povidon.
English: Methadone-containing medicines are used to treat drug addiction in patients dependent on opioids (such as heroin); methadone prevents or reduces opiate withdrawal symptoms.
Danish: Metadonholdige lægemidler bruges hos patienter, der er afhængige af opioider (f.eks. heroin).
English: market and changes will be made to the product information (SmPC and package leaflet) to reinforce the message that tablets are for oral administration only and must not be taken in any other way.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom foretaget ændringer i produktinformationen (produktresumé og indlægsseddel), hvor det fremhæves, at tabletterne kun er til oral indgift og ikke må tages på anden måde.
English: This is normal.
Danish: Dette er helt normalt.
English: Other warming methods should not be used.
Danish: Der må ikke anvendes andre opvarmningsmetoder.
English: Do not inject more than one dose within 2 days.
Danish: Du må ikke indsprøjte mere end én dosis inden for 2 dage.
English: Normal (≥140)
Danish: Normalt (≥140)
English: Wash your hands thoroughly with soap (for at least 3 minutes) and dry them well.
Danish: Vask hænderne grundigt med sæbe (i mindst 3 minutter), og tør dem godt.
English: Less than 50a, b
Danish: Mindre end 50a, b
English: Date of first authorisation: 03 May 2019
Danish: Dato for første markedsføringstilladelse: 03. maj 2019
English: The applicant will ensure the long term follow-up of patients in the Registry.
Danish: Ansøgeren vil sikre den langsigtede opfølgning af patienterne i registret.
English: Parameter at Month 3a
Danish: Parameter ved måned 3a
English: You may not know that you have this condition until this point, or what might have caused it.
Danish: Du vil muligvis ikke være klar over, at du har denne sygdom før dette tidspunkt, eller hvad der muligvis har forårsaget den.
English: Starting dose: Weekly After 3 months: Every 2 weeks
Danish: Startdosis: Ugentligt Efter tre måneder: Hver anden uge
English: A risk to the newborn infant cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: Baselinea Month 3
Danish: Baselinea Måned 3
English: Steady-state was reached approximately 3 months after starting volanesorsen.
Danish: Steady state blev nået cirka 3 måneder efter opstart af volanesorsen.
English: Your doctor will tell you how often you should take this medicine.
Danish: Lægen vil fortælle dig, hvor ofte du skal tage dette lægemiddel.
English: Age, sex, weight, and race
Danish: Alder, køn, vægt og race
English: Do not use Waylivra until you completely understand the procedure described below.
Danish: Brug ikke Waylivra, før du har forstået den nedenfor beskrevne fremgangsmåde fuldstændigt.
English: Every 2-3 days
Danish: Hver 2-3 dag
English: You should avoid alcohol during treatment with this medicine due to risk of liver issues.
Danish: Du bør undgå alkohol under behandlingen med dette lægemiddel på grund af risikoen for leverproblemer.
English: The most recent data of the ongoing Study CS7 is provided in Table 6.
Danish: De seneste data fra det igangværende studie CS7 er angivet i tabel 6.
English: Component of a multipack, can't be sold separately.
Danish: Delene i en multipakning må ikke sælges separat.
English: o Information about the FCS disease registry and the PASS study and the importance of contributing to those studies.
Danish: o Oplysninger om registret for FCS-sygdom og PASS-studiet samt vigtigheden af at bidrage til disse studier.
English: There are limited data available in subjects >75 years of age.
Danish: Der foreligger begrænsede data fra personer > 75 år.
English: Observed Value
Danish: Observere t værdi
English: Pregnancy There are no data on the use of volanesorsen in pregnant women.
Danish: Graviditet Der er ingen data om anvendelse af volanesorsen til gravide kvinder.
English: Symptoms of overdose are expected to be limited to constitutional symptoms and injection site reactions.
Danish: Symptomerne på overdosering forventes at være begrænset til konstitutionelle symptomer og reaktioner på injektionsstedet.
English: were identified in human urine.
Danish: deletioner)) blev identificeret i human urin.
English: If 1 visit was missing, then the other visit was used as the endpoint.
Danish: Hvis patienten ikke kom til et af besøgene, blev det andet besøg anvendt som endepunkt.
English: c The denominator for percentage calculation was the total number of patients in each treatment group.
Danish: c Nævneren for procentberegningen var det totale antal patienter i hver behandlingsgruppe.
English: 50 to 74a
Danish: 50-74a
English: For all injections:
Danish: Gælder alle injektioner:
English: Do not warm syringe in any other way, such as by microwave or warm water.
Danish: Du må ikke opvarme sprøjten på andre måder, f.eks. i mikrobølgeovnen eller varmt vand.
English: Please note that the expiry date refers to the last day of that month.
Danish: Udløbsdatoen er den sidste dag i den nævnte måned.
English: After the Injection 12.
Danish: Efter injektionen 12.
English: If injected in the upper arm, the injection should be administered by another person.
Danish: Ved injektion i overarmen bør injektionen administreres af en anden person.
English: Do not use this medicine after the expiry date which is stated on the carton and syringe label after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og etiketten på sprøjten efter 'Exp'.
English: The safety and efficacy of this medicinal product in children and adolescents below 18 years of age have not yet been established.
Danish: Dette lægemiddels sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: This medicinal product is intended for subcutaneous use only.
Danish: Dette lægemiddel er udelukkende beregnet til subkutan brug.
English: Relative Difference in Change vs Placebo
Danish: Relativ forskel i ændring vs. placebo
English: The median age at diagnosis was 27 years, with 23% shown to lack a known FCS genetic mutation.
Danish: Gennemsnitsalderen ved diagnosticeringen var 27 år, og 23 % udviste mangel på en kendt FCS-genmutation.
English: The decrease was gradual, self-sustaining and did not decrease to adverse levels.
Danish: Faldet var gradvist og selvbærende og faldt ikke til et kritisk niveau.
English: Waylivra should be inspected visually prior to administration.
Danish: Waylivra skal kontrolleres visuelt inden administration.
English: As a precautionary measure, it is preferable to avoid the use of this medicinal product during pregnancy.
Danish: Som forholdsregel er det at foretrække at undgå brug af dette lægemiddel i graviditeten.
English: It is preferable to avoid the use of Waylivra during pregnancy.
Danish: Det er bedst at undgå anvendelse af Waylivra under graviditet.
English: No overall differences in safety or effectiveness were observed between these patients and younger patients, however data are limited in this subpopulation.
Danish: Der blev ikke set nogen overordnede forskelle i sikkerheden eller virkningen mellem disse patienter og yngre patienter; der er imidlertid begrænsede data i denne subpopulation.
English: % Change
Danish: Ændring i %
English: No clinical drug interaction studies have been conducted.
Danish: Der er ikke udført kliniske interaktionsstudier.
English: Remove the syringe and inspect the medicine
Danish: Tag sprøjten ud, og kontrollér medicinen
English: It is normal to see a large air bubble (Figure D).
Danish: Det er helt normalt, hvis du ser en stor luftboble (figur D).
English: Place the following items on a clean, flat surface in a well-lit area (Figure A).
Danish: Anbring følgende artikler på en ren, flad overflade i et område med god belysning (figur A).
English: You may notice this if you have an injury which causes bleeding and it takes a long time to stop (more than 5-6 minutes for a skin scratch).
Danish: Dette kan f.eks. ses, hvis du kommer til skade og bløder, og det tager lang tid, før blødningen stopper (mere end 5-6 minutter for en rift i huden).
English: Pinch the skin
Danish: Klem fat om huden
English: The decrease in platelet counts was not acute and decreased to below 50,000 cells/μl.
Danish: Faldet i trombocyttallet var ikke akut og faldt til under 50.000 celler/μl.
English: It may be necessary to consult a doctor specialising in blood disorders to determine whether you should continue treatment with Waylivra or not.
Danish: Det vil muligvis være nødvendigt at konsultere en læge med speciale i blodsygdomme for at afgøre, om du skal fortsætte behandlingen med Waylivra.
English: Patients taking Glybera within 2 years prior to screening were excluded from the study.
Danish: Patienter, som havde fået Glybera inden for 2 år før screening, var ekskluderet fra studiet.
English: This medicinal product should be inspected visually prior to administration.
Danish: Dette lægemiddel skal kontrolleres visuelt inden administration.
English: Nineteen of the 33 patients in the volanesorsen group completed 12 months of study treatment.
Danish: Nitten ud af de 33 patienter i volanesorsengruppen fuldførte 12 måneders studiebehandling.
English: If you do not have a sharps disposal container, you may use a household container that is:
Danish: Hvis du ikke har en kanylebeholder, kan du bruge en husholdingsbeholder, som:
English: LDL-C Levels
Danish: LDL-C-niveauer
English: This medicine is intended for patients aged 18 years and above.
Danish: Dette lægemiddel er beregnet til patienter over 18 år.
English: - you are allergic to volanesorsen or any of the other ingredients in this medicine (listed in section 6).
Danish: - hvis du er allergisk over for volanesorsen eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: 0 NC
Danish: 0 NC NC
English: Compliance with diet and alcohol restriction was reinforced through periodic counselling sessions during the study.
Danish: Patienternes efterlevelse af diæten og alkoholbegrænsningen blev styrket ved hjælp af regelmæssige rådgivningssessioner i løbet af studiet.
English: Look at the liquid in the syringe.
Danish: Se på væsken i sprøjten.
English: Your doctor will test for this before treatment with this medicine is started.
Danish: Lægen vil kontrollere dig for dette inden opstart af behandling med dette lægemiddel.
English: Pharmacotherapeutic group:{Not yet assigned}, ATC code: {Not yet assigned} Mechanism of action
Danish: Farmakoterapeutisk klassifikation:{endnu ikke tildelt}, ATC-kode: {endnu ikke tildelt}
English: It is recommended that you discuss breast-feeding with your doctor to see what is best for you and your child.
Danish: Du bør drøfte amning med lægen for at finde ud af, hvad der er bedst for dig og dit barn.
English: These local reactions were mostly mild and typically consisted of 1 or more of the following: erythema, pain, pruritus, or local swelling.
Danish: Disse lokale reaktioner var oftest milde og bestod typisk af 1 ellerflere af følgende symptomer: erythem, smerter, pruritus eller lokal hævelse.
English: The active substance is volanesorsen.
Danish: Aktivt stof: volanesorsen.
English: Treatment should be initiated by and remain under the supervision of a physician experienced in the treatment of patients with FCS.
Danish: Behandlingen bør iværksættes af og holdes under opsyn af en læge med erfaring i behandling af patienter med FCS.
English: Treatment and monitoring should be adjusted according to laboratory values in line with Table 1.
Danish: Behandlingen og monitoreringen bør tilpasses i henhold til laboratorieværdierne i tabel 1.
English: Do not administer intramuscularly or intravenously.
Danish: Må ikke administreres intramuskulært eller intravenøst.
English: Do not stop using Waylivra unless you have discussed stopping your medicine with your doctor.
Danish: Du må ikke holde op med at bruge Waylivra, medmindre du har drøftet det med lægen.
English: The concentrations in breast milk of mice were >800 fold lower than effective tissue concentrations in maternal liver.
Danish: Koncentrationen i mælken hos mus var > 800 gange lavere end de effektive vævskoncentrationer i moderens lever.
English: • Properly labeled to warn of hazardous waste inside the container.
Danish: • Er mærket korrekt, så man kan se, at den indeholder farligt affald.
English: In clinical studies, this medicinal product has been used in combination with fibrates and fish oils with no impact on the medicinal product pharmacodynamics or pharmacokinetics.
Danish: I kliniske studier er dette lægemiddel blevet anvendt i kombination med fibrater og fiskeolier uden nogen indvirkning på lægemidlets farmakodynamik eller farmakokinetik.
English: Patients with lower body weight (less than 70 kg) may be more prone to thrombocytopenia during treatment with this medicinal product.
Danish: Patienter med lav legemsvægt (under 70 kg) kan have større tendens til trombocytopeni under behandlingen med dette lægemiddel.
English: Following subcutaneous administration, terminal elimination half-life is approximately 2 to 5 weeks.
Danish: Efter subkutan administration er den terminale eliminationshalveringstid cirka 2 til 5 uger.
English: Unchanged volanesorsen is the predominant circulating component.
Danish: Uomdannet volanesorsen er det dominerende cirkulerende stof.
English: If necessary, your doctor may change how often you use this medicine, or may stop it for a period.
Danish: Lægen vil om nødvendigt ændre på, hvor ofte du skal bruge dette lægemiddel, eller stoppe behandlingen i en periode.
English: After commencing treatment, patients should have platelet levels monitored at least every two weeks, depending on the platelet levels.
Danish: Efter opstart af behandlingen bør patienterne have kontrolleret deres trombocyttal mindst hver anden uge, afhængigt af trombocytniveauet.
English: There is no clinical experience with overdose of this medicinal product.
Danish: Der er ingen klinisk erfaring med overdosering af dette lægemiddel.
English: b) Post heparin plasma LPL activity of ≤ 20% of normal.
Danish: b) LPL-aktivitet i plasma efter heparin ≤ 20 % af normalen.
English: Before using this medicine, it is important that you read, understand, and closely follow the instructions for use.
Danish: Inden du bruger dette lægemiddel, er det vigtigt, at du har læst og forstået anvisningerne i denne brugsvejledning, som du skal følge nøje.
English: Waylivra has not been studied in patients under 18 years old.
Danish: Waylivra er ikke blevet undersøgt hos patienter under 18 år.
English: In animals, elimination of volanesorsen was slow and occurred mainly via urinary excretion, reflecting rapid plasma clearance principally to tissues.
Danish: Hos dyr var eliminationen af volanesorsen langsom og skete primært via udskillelse i urinen, hvilket afspejler hurtig plasmaclearance, primært til vævene.
English: If administering an injection to someone else as a caregiver, in addition to the above sites:
Danish: Hvis du er omsorgsperson og skal give en injektion til en anden; udover ovennævnte steder:
English: None of these patients had any major bleeding events and all recovered to normal platelet count following drug discontinuation and administration of glucocorticosteroids where medically indicated.
Danish: Ingen af disse patienter havde nogen større blødningshændelser, og alle genvandt normale trombocyttal efter seponering af lægemidlet og administration af glukokortikosteroider, hvor dette var indiceret.
English: Most patients receiving volanesorsen experienced a clinically significant reduction in triglycerides.
Danish: De fleste af de patienter, der fik volanesorsen, oplevede en klinisk signifikant reduktion i triglycerider.
English: With treatment with Waylivra, LDL-C levels may rise but will usually remain within the normal range.
Danish: LDL-C-niveauet kan stige under behandlingen med Waylivra, men det forbliver som regel inden for normalområdet.
English: Injection site reactions did not occur with all injections and resulted in discontinuation for 1 patient in the APPROACH study.
Danish: Reaktioner på injektionsstedet forekom ikke med alle injektioner og resulterede i seponering hos 1 patient i APPROACH-studiet.
English: Alternate the injection area for each injection.
Danish: Skift injektionsområde ved hver injektion.
English: Clear, colourless to slightly yellow solution with a pH of approximately 8 and osmolarity of 363-485 mOsm/kg.
Danish: Klar, farveløs til let gullig opløsning med en pH på cirka 8 og en osmolalitet på 363-485 mOsm/kg.
English: The effect of concomitant administration of this medicinal product with alcohol or medicinal products known to have potential for hepatotoxicity (e.g., paracetamol) is unknown.
Danish: Virkningen af samtidig administration af dette lægemiddel og alkohol eller lægemidler, der kan forårsage hepatotoksicitet (f.eks. paracetamol) kendes ikke.
English: The MAH shall ensure that in each Member State where Waylivra is marketed, all healthcare professionals, patients and carers who are expected to prescribe, dispense and use Waylivra have access to/are provided with the following educational package:
Danish: MAH skal i hvert medlemsland, hvor Waylivra markedsføres, sikre, at alt sundhedspersonale, alle patienter og og omsorgsgivere, der forventes at ordinere, udlevere og anvende Waylivra, har adgang til/er forsynet med følgende uddannelsespakke:
English: They may change how often you use it, or may stop it for a period or permanently, depending on the results of your blood and urine tests or occurrence of side effects.
Danish: Lægen kan ændre på, hvor ofte du skal bruge det, eller stoppe behandlingen i en periode eller permanent på baggrund af dine blod- og urinprøveresultater eller forekomsten af bivirkninger.
English: Urinary recovery of the parent drug was limited in humans with < 3% of administered subcutaneous dose recovered within 24 hours post dose.
Danish: Genfindelsen af moderstoffet i urinen var begrænset hos mennesker, idet < 3 % af den administrerede subkutane dosis blev genfundet i løbet af 24 timer efter dosering.
English: Thirteen of these patients had dose adjustment/pause on the study.
Danish: Tretten af disse patienter fik doseringen justeret/pauseret i løbet af studiet.
English: It is unknown whether volanesorsen or metabolites are excreted in human milk.
Danish: Det er ukendt, om volanesorsen eller dets metabolitter udskilles i human mælk.
English: The selective binding of volanesorsen to the apoC-III messenger ribonucleic acid (mRNA) within the 3′ untranslated region at base position 489-508 causes the degradation of the mRNA.
Danish: Volanesorsens selektive binding til apoC-III-messenger-ribonukleinsyre (mRNA) inden for den ikke-translaterede region 3′ ved baseposition 489-508 forårsager nedbrydning af mRNA.
English: - Medicines that may cause problems with your liver, such as paracetamol.
Danish: - Lægemidler, der kan forårsage leverproblemer, såsom paracetamol.