FrancophonIA/ELRC3.0 huggingface dataset:
English: GT3b is a subtype reported in a relatively small number of HCV infected patients in China and a few countries in South and Southeast Asia, but rarely outside of this region.
Danish: GT3b er en undertype rapporteret hos et forholdsvist lille antal HCV-inficerede patienter i Kina og nogle få lande i syd- og sydøstasien, men sjældent uden for denne region.
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000),meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The response rates observed for patients ≥ 65 years of age were similar to that of patients < 65 years of age, across treatment groups.
Danish: Patienter ≥ 65 år havde samme responsrate som patienter < 65 år på tværs af behandlingsgrupperne.
English: Co-administration with darunavir is not recommended.
Danish: Samtidig administration af darunavir anbefales ikke.
English: Take all 3 tablets in 1 blister once daily with food
Danish: Tag alle 3 tabletter fra 1 blister én gang dagligt sammen med mad.
English: The presence of HIV-1 coinfection did not impact efficacy.
Danish: Samtidig tilstedeværelse af HIV-1-infektion påvirkede ikke effekten.
English: Pharmacokinetics in special populations
Danish: Farmakokinetikken hos særlige populationer
English: HBV screening should be performed in all patients before initiation of treatment.
Danish: Der bør foretages HBV-screening af alle patienter, før behandlingen igangsættes.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteren efter EXP.
English: Larger increases may be expected when unbound concentration is considered.
Danish: Større stigninger kan forventes, når koncentrationen af ubundet stof medtages.
English: Table 3: Interactions between Maviret and other medicinal products
Danish: Tabel 3: Interaktioner mellem Maviret og andre lægemidler
English: If you forget to take Maviret
Danish: Hvis du har glemt at tage Maviret
English: ↔ ↔ ↔ No dose adjustment is required.
Danish: ↔ ↔ ↔ Dosisjustering er ikke nødvendigt.
English: Maviret is not recommended for use in patients requiring stable ciclosporin doses > 100 mg per day.
Danish: Maviret anbefales ikke hos patienter, der skal have stabile ciclosporin-doser > 100 mg dagligt.
English: If the combination is unavoidable, use can be considered if the benefit outweighs the risk with a close clinical monitoring.
Danish: Hvis kombinationen ikke kan undgås, kan anvendelse overvejes, hvis fordelen opvejer risikoen, og hvis der foretages tæt monitorering.
English: b. Mean systemic exposure with moderate to high fat meals.
Danish: b. Gennemsnitlig systemisk eksponering ved måltider med moderat til højt fedtindhold.
English: Interactions with fluvastatin and pitavastatin are likely and caution is recommended during the combination.
Danish: Interaktion med fluvastatin og pitavastatin er sandsynligt, og det anbefales at udvise forsigtighed ved kombination.
English: Adults and adolescents aged 12 to <18 years
Danish: Voksne og unge fra 12 til <18 år
English: Bilirubin elevations were asymptomatic, transient, and typically occurred early during treatment.
Danish: Forhøjet bilirubin var asymptomatisk, forbigående og sås typisk tidligt i behandlingen.
English: Maviret works by stopping the hepatitis C virus from multiplying and infecting new cells.
Danish: Maviret virker ved at forhindre hepatitis C-virusset i at formere sig og inficere nye celler.
English: Not studied.
Danish: Ikke undersøgt.
English: The most commonly reported adverse reactions (incidence ≥ 10%) were headache and fatigue.
Danish: De hyppigst rapporterede bivirkninger (incidens ≥ 10 %) var hovedpine og træthed.
English: ANGIOTENSIN-II RECEPTOR BLOCKERS Losartan
Danish: ANGIOTENSIN II-RECEPTOR-BLOKKERE Losartan
English: As a precautionary measure, Maviret use is not recommended in pregnancy.
Danish: Som forsigtighedsforanstaltning anbefales Maviret ikke under graviditet.
English: • Do not chew, crush or break the tablets as it may affect the amount of Maviret in your blood.
Danish: • Du må ikke tygge, knuse eller dele tabletterne, da det kan påvirke mængden af Maviret i blodet.
English: Major route of elimination
Danish: Væsentligste eliminationsvej
English: Direct hyperbilirubinemia was reported in 0.3% of subjects.
Danish: Direkte hyperbilirubinæmi blev indberettet hos 0,3 % af forsøgspersonerne.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine, as the use of Maviret in pregnancy is not recommended.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel, da det ikke anbefales at anvende Maviret til gravide.
English: Maviret should not affect your ability to drive or use any tools or machines.
Danish: Maviret burde ikke påvirke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Maviret, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Danish: Med henblik på at evaluere recidiv af hepatocellulært karcinom forbundet med Maviret skal indehaveren af markedsføringstilladelsen gennemføre og indsende resultaterne af et prospektivt sikkerhedsstudie ved hjælp af data fra en kohorte af en veldefineret gruppe af patienter på grundlag af en godkendt protokol.
English: Hepatitis B Virus reactivation
Danish: Reaktivering af hepatitis B-virus
English: Do not give this medicine to children under 12 years of age.
Danish: Dette lægemiddel må ikke anvendes til børn under 12 år.
English: c. Single dose administration of [14C]glecaprevir or [14C]pibrentasvir in mass balance studies.
Danish: c. Enkeltdosisadministration af [14C]-glecaprevir eller [14C]-pibrentasvir i massebalancestudier.
English: No clinically significant interactions are expected with tenofovir disoproxil fumarate.
Danish: Der forventes ingen klinisk signifikante interaktioner med tenofovirdisoproxilfumarat.
English: The non-linear exposure increase <120 mg may be related to saturation of efflux transporters.
Danish: Den ikke-lineære stigning i eksponering <120 mg kan skyldes mætning af efflukstransportere.
English: SOF+DCV 12 weeks N=115
Danish: SOF+DCV 12 uger N = 115
English: Pravastatin dose should not exceed 20 mg per day and rosuvastatin dose should not exceed 5 mg per day.
Danish: Pravastatin-dosen bør ikke overstige 20 mg pr. dag, og rosuvastatin-dosen bør ikke overskride 5 mg dagligt.
English: The adverse reactions observed were comparable with those observed in clinical studies of Maviret in adults.
Danish: De observerede bivirkninger var sammenlignelige med dem, der blev observeret i kliniske studier af Maviret hos voksne.
English: 35 µg/250 µg once daily
Danish: 35 µg/250 µg én gang dagligt
English: If you accidentally take more than the recommended dose, contact your doctor or go to the nearest hospital straight away.
Danish: Hvis du er kommet til at tage mere end den anbefalede dosis, skal du omgående kontakte lægen eller tage til den nærmeste skadestue.
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines.
Danish: Patienter med samtidig HBV-og HCV-infektion er i risiko for reaktivering af HBV og bør derfor overvåges og behandles i henhold til gældende kliniske retningslinjer.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Maviret.
Danish: Nogle patienter med diabetes har oplevet lavt blodsukker (hypoglykæmi) efter påbegyndelse af behandling med lægemidler som Maviret.
English: As liver function may change during treatment with Maviret, a close monitoring of International Normalised Ratio (INR) values is recommended.
Danish: Da leverfunktionen kan blive påvirket ved behandling med Maviret, anbefales det at overvåge INRværdierne tæt (international normaliseret ratio).
English: Maviret treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Danish: Behandling med Maviret skal påbegyndes og overvåges af en læge med erfaring i behandling af patienter med HCV-infektion.
English: Co-administration is not recommended.
Danish: Samtidig administration anbefales ikke.
English: The following adverse reactions were identified in patients treated with Maviret.
Danish: Følgende bivirkninger blev identificeret hos patienter behandlet med Maviret.
English: • diarrhoea
Danish: • Diarré
English: The proportion of subjects treated with Maviret who permanently discontinued treatment due to adverse reactions was 0.1%.
Danish: Andelen af de Maviret-behandlede forsøgspersoner, der fik seponeret behandlingen permanent på grund af bivirkninger, var 0,1 %.
English: The mechanism for the differences between glecaprevir exposure in chronic Hepatitis C patients with or without cirrhosis is unknown.
Danish: Mekanismen for forskellene mellem glecaprevir-eksponering hos kroniske hepatitis C-patienter med eller uden cirrose kendes ikke.
English: GT 1, 2, 4-6 8 weeks
Danish: GT 1, 2, 4-6 8 uger
English: If you do miss a dose, work out how long it is since you should have last taken Maviret:
Danish: Hvis du har glemt at tage en dosis, skal du vurdere, hvor lang tid der er gået, siden du skulle have taget Maviret:
English: Patients should be instructed to swallow tablets whole with food and not to chew, crush or break the tablets as it may alter the bioavailability of the agents (see section 5.2).
Danish: Patienterne skal have at vide, at de skal sluge tabletterne hele sammen med mad, og at de ikke må tygge, knuse eller dele tabletterne, da dette kan ændre stoffernes biotilgængelighed (se pkt.
English: Talk to your doctor if you have the following because your doctor may want to check you more closely:
Danish: Tal med lægen, hvis følgende gælder for dig, da han/hun i givet fald vil overvåge dig tættere:
English: 8 weeks
Danish: 8 uger
English: Bilirubin elevations were predominantly indirect and not associated with ALT elevations.
Danish: Forhøjet bilirubin var primært indirekte og var ikke forbundet med forhøjet ALAT.
English: Median EC50, nM (range)
Danish: Median EC50, nM (interval)
English: Maviret tablets are packed into foil blisters, each containing 3 tablets.
Danish: Maviret-tabletter er pakket i folieblistre, der hver indeholder 3 tabletter.
English: Co-administration with efavirenz may lead to reduced therapeutic effect of Maviret and is not recommended.
Danish: Samtidig administration med efavirenz kan medføre nedsat terapeutisk effekt af Maviret og anbefales ikke.
English: In case of overdose, the patient should be monitored for any signs and symptoms of toxicities (see section 4.8).
Danish: I tilfælde af overdosering skal patienten overvåges for tegn og symptomer på toksicitet (se pkt.
English: This is so that your doctor can decide if:
Danish: Derved kan lægen:
English: • your treatment has worked and you are free of the hepatitis C virus.
Danish: • vurdere, om din behandling har virket, og om du er fri for hepatitis C-virus.
English: Glucose levels of diabetic patients initiating direct acting antiviral therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Danish: Blodsukkeret hos patienter med diabetes, der påbegynder behandling med direkte virkende antivirale lægemidler, bør overvåges nøje, navnlig inden for de første 3 måneder, og patienternes diabetesmedicinering bør om nødvendigt ændres.
English: What you need to know before you take Maviret 3.
Danish: Det skal du vide, før du begynder at tage Maviret 3.
English: If used, lovastatin should not exceed a dose of 20 mg/day and patients should be monitored.
Danish: Hvis lovastatin anvendes, bør den daglige dosis ikke overstige 20 mg, og patienten bør monitoreres.
English: b. Includes a total of 154 subjects coinfected with HIV-1 in ENDURANCE-1 and EXPEDITION-2 who received the recommended duration.
Danish: b. Inkluderer samlet 154 forsøgspersoner, med samtidig HIV-1 i ENDURANCE-1 og EXPEDITION-2, som fik behandling af den anbefalede varighed.
English: The overall prevalence of A30K and Y93H at baseline was 6.5% and 4.9%, respectively.
Danish: Den overordnede forekomst af A30K og Y93H ved baseline var hhv. 6,5 % og 4,9 %.
English: Less than 0.1% of subjects treated with Maviret had serious adverse reactions (transient ischaemic attack).
Danish: Under 0,1 % af de forsøgspersoner, der blev behandlet med Maviret, fik alvorlige bivirkninger (transitorisk cerebral iskæmi).
English: Subjects with genotype 3b infection
Danish: Forsøgspersoner med genotype 3b infektion
English: Genotype 1, 2, 4, 5, and 6: Baseline polymorphisms in genotypes 1, 2, 4, 5 and 6 had no impact on treatment outcome.
Danish: Genotype 1, 2, 4, 5 og 6: Polymorfismer ved baseline hos genotype 1, 2, 4, 5 og 6 havde ingen indvirkning på behandlingsresultatet.
English: Table 4: Adverse reactions identified with Maviret Frequency
Danish: Tabel 4: Bivirkninger, der er set ved Maviret Hyppighed
English: The use of Maviret in children under 12 years of age has not yet been studied.
Danish: Anvendelsen af Maviret hos børn under 12 år er endnu ikke undersøgt.
English: The overall safety profile in transplant recipients was comparable to that observed in subjects in the Phase 2 and 3 studies.
Danish: Den overordnede sikkerhedsprofil hos transplanterede var sammenlignelig med den, der blev set hos forsøgspersoner i fase 2 og 3 studier.
English: The pharmacokinetics of glecaprevir and pibrentasvir have not been established in paediatric patients <12 years of age.
Danish: Glecaprevirs og pibrentasvirs farmakokinetik er ikke fastslået hos pædiatriske patienter <12 år.
English: Biliary excretion Biliary excretion t1/2 (h) at steady-state % of dose excreted in urinec % of dose excreted in faecesc
Danish: Biliær udskillelse Biliær udskillelse t1/2 (h) ved steady-state % af dosis, der udskilles i urinenc % af dosis, der udskilles i fæcesc
English: Established and other potential medicinal product interactions
Danish: Fastlagte og andre mulige lægemiddelinteraktioner
English: • Swallow the tablets whole.
Danish: • Synk tabletterne hele.
English: This may make Maviret work less well.
Danish: Derved kan virkningen af Maviret blive mindre.
English: Sustained virologic response (SVR12), defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment, was the primary endpoint in all the studies to determine the HCV cure rate.
Danish: Vedvarende virologisk respons (SVR12), defineret som HCV-RNA-niveauer, der ligger under LLOQ 12 uger efter behandlingsophør, var det primære effektmål i alle studierne ved vurdering af helbredelsesraten ved HCV.
English: It is not known whether the two medicines in Maviret pass into breast milk.
Danish: Det er ukendt, om de to aktive stoffer i Maviret udskilles i brystmælk.
English: Skin and subcutaneous tissue disorders Not known pruritus
Danish: Hud og subkutane væv Ikke kendt
English: • diabetes.
Danish: • du har diabetes.
English: Significant inhibition of CYP1A2, CYP2C9, CYP2C19, CYP2D6, UGT1A6, UGT1A9, UGT1A4, UGT2B7, OCT1, OCT2, OAT1, OAT3, MATE1 or MATE2K are not expected.
Danish: Signifikant hæmning af CYP1A2, CYP2C9, CYP2C19, CYP2D6, UGT1A6, UGT1A9, UGT1A4, UGT2B7, OCT1, OCT2, OAT1, OAT3, MATE1 eller MATE2K forventes ikke.
English: Exposures of glecaprevir and pibrentasvir in adolescents aged 12 to <18 years were comparable to those in adults from Phase 2/3 studies.
Danish: Eksponering for glecaprevir og pibrentasvir hos unge i alderen fra 12 til <18 år var sammenlignelige med voksne i fase 2/3 studier.
English: Clinical studies of Maviret included 328 patients aged 65 and over (13.8% of the total number of subjects).
Danish: Ældre De kliniske studier med Maviret omfattede 328 patienter i alderen 65 år og derover (13,8 % af det samlede antal forsøgspersoner).
English: If you are sick (vomit) after taking Maviret it may affect the amount of Maviret in your blood.
Danish: Hvis du kaster op efter at have taget Maviret, kan det påvirke mængden af Maviret i blodet.
English: See Table 3 for specific recommendations on interactions with sensitive substrates of P-gp, BCRP, and OATP1B1/3.
Danish: Se tabel 3 for specifikke anbefalinger, om interaktioner med følsomme substrater for P-gp, BCRP og OATP1B1/3.
English: Ten of 113 subjects treated with Maviret in the MAGELLAN-1 study for 12 or 16 weeks experienced virologic failure.
Danish: 10 af de 113 forsøgspersoner, der blev behandlet med Maviret i MAGELLAN- 1-studiet i 12 eller 16 uger, oplevede virologisk svigt.
English: The pharmacokinetic properties of the components of Maviret are provided in Table 11.
Danish: De farmakokinetiske egenskaber ved bestanddelene i Maviret er vist i tabel 11.
English: For other P-gp, BCRP, or OATP1B1/3 substrates, dose adjustment may be needed.
Danish: For andre P-gp-, BCRP- eller OATP1B1/3-substrater kan en dosisjustering være nødvendig.
English: Omeprazole 40 mg once daily (1 hour before breakfast)
Danish: Omeprazol 40 mg én gang dagligt (1 time før morgenmaden)
English: Clinical comments
Danish: Kliniske kommentarer
English: Systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 63 and 102 times higher, respectively, than the exposure in humans at the recommended dose.
Danish: Den systemiske eksponering (AUC) for glecaprevir og pibrentasvir var hhv. ca. 63 og 102 gange højere end eksponeringen hos mennesker ved den anbefalede dosis.
English: No re-treatment data is available for patients infected with genotypes 2, 3, 5 or 6.
Danish: Der er ingen tilgængelige data vedrørende fornyet behandling hos patienter inficeret med genotype 2, 3, 5 eller 6.
English: The in vitro activity of glecaprevir was also studied in a biochemical assay, with similarly low IC50 values across genotypes.
Danish: Glecaprevirs in vitro-aktivitet blev også undersøgt i en biokemisk analyse og udviste samme lave IC50værdier hos alle genotyper.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Maviret.
Danish: Det kan være, at dit blodsukker skal overvåges tættere, og/eller at din diabetesmedicin skal justeres efter påbegyndelse af behandling med Maviret.
English: Glecaprevir is affected to a lower extent by coadministration with pibrentasvir.
Danish: Glecaprevir er påvirket i mindre grad ved samtidig administration med pibrentasavir.
English: A166S or Q168R were present at baseline and post-treatment in 5 subjects.
Danish: A166S eller Q168R var til stede ved baseline og efter behandlingen hos 5 forsøgspersoner.
English: It is unknown whether glecaprevir or pibrentasvir are excreted in human milk.
Danish: Det er ukendt, om glecaprevir og pibrentasvir udskilles i human mælk.
English: The mechanism of action of pibrentasvir has been characterized based on cell culture antiviral activity and drug resistance mapping studies.
Danish: Pibrentasvirs virkningsmekanisme er beskrevet ud fra antiviral aktivitet i cellekulturer og undersøgelser af lægemiddelresistens.
English: ENDURANCE-3 was a partially-randomized, open-label, active-controlled study in treatment-naïve subjects.
Danish: ENDURANCE-3 er et åbent, delvist randomiseret, aktivkontrolleret studie med behandlingsnaive forsøgspersoner.
English: Caution and therapeutic concentration monitoring of digoxin is recommended.
Danish: Der bør udvises forsigtighed og det anbefales at foretage overvågning af den terapeutiske koncentration af digoxin.
English: • atazanavir (for HIV infection)
Danish: • atazanavir (mod hiv-infektion)
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: • rifampicin (for infections)
Danish: • rifampicin (mod infektion)
English: Maviret has no or negligible influence on the ability to drive and use machines.
Danish: Maviret påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: What you need to know before you take Maviret Do not take Maviret if:
Danish: Det skal du vide, før du begynder at tage Maviret Tag ikke Maviret:
English: Among treatment-experienced subjects, 46% (42/91) failed a previous regimen containing sofosbuvir.
Danish: Blandt de behandlingserfarne forsøgspersoner havde 46 % (42/91) oplevet behandlingssvigt ved et tidligere regime med sofosbuvir.
English: Studies in rats/mice with glecaprevir or pibrentasvir do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: Forsøg med glecaprevir og pibrentasvir hos rotter/mus indikerer ingen direkte eller indirekte skadelige virkninger, hvad angår reproduktionstoksicitet.
English: To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker at rekvirere denne indlægsseddel som lydfil eller i brailleskrift eller magnaprint, kan du kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Hypromellose 2910 (E464) Lactose monohydrate Titanium dioxide Macrogol 3350
Danish: Hypromellose 2910 (E464) Lactosemonohydrat Titaniumdioxid Macrogol 3350
English: No dose adjustment of Maviret is required in elderly patients.
Danish: Dosisjustering af Maviret er ikke nødvendig hos ældre patienter.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Maviret therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Maviret skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for kvinden.
English: Glecaprevir is also a substrate of the hepatic uptake transporters OATP1B1/3.
Danish: Glecaprevir er også et substrat for de hepatiske uptake-transportere OATP1B1/3.
English: The overall safety profile in HCV/HIV-1 co-infected subjects (ENDURANCE-1 and EXPEDITION2) was comparable to that observed in HCV mono-infected subjects.
Danish: Den overordnede sikkerhedsprofil hos HCV/HIV-1-smittede forsøgspersoner (ENDURANCE-1 og EXPEDITION-2) var sammenlignelig med det, der blev set hos HCV-monoinficerede personer.
English: (Inhibition of UGT1A1)
Danish: (Hæmning af UGT1A1)
English: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Danish: Der er rapporteret om tilfælde af reaktivering af hepatitis B-virus (HBV), nogle med dødelig udgang, under og efter behandling med direkte virkende antivirale midler.
English: Clinically significant increases in exposure were not observed for sensitive substrates of CYP3A (midazolam, felodipine) or UGT1A1 (raltegravir) when administered with Maviret.
Danish: Klinisk signifikante stigninger i eksponering blev ikke observeret for følsomme substrater af CYP3A (midazolam, felodipin) eller UGT1A1 (raltegravir), når disse blev givet sammen med Maviret.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Maviret.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), skal du tale med lægen eller apotekspersonalet, før du tager Maviret.