FrancophonIA/ELRC3.0 huggingface dataset:
English: Italia Mylan Italia S.r.l.Tel: + 39 02 612 46921
Danish: Tel: + 39 02 612 46921
English: Valproic acid/Efavirenz (250 mg b.i.d./600 mg q.d.)
Danish: Valproat/efavirenz (250 mg b.i.d./ 600 mg q.d.)
English: AUC: ↓ 83% (↓ 79 to ↓ 87) Cmax: ↓ 80% (↓ 77 to ↓ 83) Cmin: ↓ 86% (↓ 80 to ↓ 90) (induction of metabolism) Efavirenz: no clinically significant interaction.
Danish: Cmin: ↓ 8% (↑ 14 til ↓ 25) Norelgestromin (aktiv metabolit): AUC: ↓ 64% (↓ 62 til ↓ 67) Cmax: ↓ 46% (↓ 39 til ↓ 52) Cmin: ↓ 82% (↓ 79 til ↓ 85) Levonorgestrel (aktiv metabolit): AUC: ↓ 83% (↓ 79 til ↓ 87) Cmax: ↓ 80% (↓ 77 til ↓ 83) Cmin: ↓ 86% (↓ 80 til ↓ 90) (induktion af metabolisme) Efavirenz: ingen klinisk signifikant interaktion.
English: Efavirenz/emtricitabine/tenofovir disoproxil and fluoxetine can be coadministered without dose adjustment.
Danish: Efavirenz/emtricitabin/tenofovirdi soproxil og fluoxetin kan administreres samtidigt uden dosisjustering.
English: Dosage adjustments of pravastatin may be required when co-administered with efavirenz/emtricitabine/tenofovir disoproxil (refer to the Summary of Product Characteristics for pravastatin).
Danish: Dosisjustering af pravastatin kan være nødvendig, når det administreres samtidigt med efavirenz/emtricitabin/tenofovirdi soproxil (se produktresuméet for pravastatin).
English: AUC: ↓ 10% C12h: ↓ 13%
Danish: C12t: ↓ 13%
English: Insufficient data are available to make a dosing recommendation for indinavir when dosed with efavirenz/emtricitabine/tenofovir disoproxil.
Danish: Der er ikke tilstrækkelig dokumentation til en doseringsanbefaling for indinavir ved dosering sammen med efavirenz/emtricitabin/tenofovirdi soproxil.
English: Dosage adjustments of simvastatin may be required when co-administered with efavirenz/emtricitabine/tenofovir disoproxil (refer to the Summary of Product Characteristics for simvastatin).
Danish: Dosisjustering af simvastatin kan være nødvendig, når det administreres samtidigt med efavirenz/emtricitabin/tenofovirdi soproxil (se produktresuméet for simvastatin).
English: Efavirenz/emtricitabine/tenofovir disoproxil is contraindicated in patients with severe hepatic impairment (see section 4.3) and not recommended in patients with moderate hepatic impairment.
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil er kontraindiceret hos patienter med svært nedsat leverfunktion (se pkt.
English: How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Danish: Sådan skal De tage Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
English: or sofosbuvir/velpatasvir/voxilaprevir is expected to decrease plasma concentrations of velpatasvir and voxilaprevir.
Danish: Samtidig administration af efavirenz/emtricitabin/tenofovirdi soproxil og sofosbuvir/velpatasvir eller sofosbuvir/velpatasvir/ voxilaprevir forventes at reducere plasmakoncentrationer af velpatasvir og voxilaprevir.
English: Prior PI-based regimen (N=34)
Danish: Tidligere proteasehæmmer-baseret behandling (N=34)
English: Cmax: ↔ (CYP3A4 induction)
Danish: AUC: ↓ 17% Cmax: ↔ (CYP3A4-induktion)
English: Since efavirenz/emtricitabine/tenofovir disoproxil is a fixed-dose combination product, the dose of efavirenz cannot be altered; therefore, voriconazole and efavirenz/emtricitabine/tenofovir disoproxil must not be coadministered.
Danish: Da efavirenz/emtricitabin/tenofovirdisoproxil er et fastdosis-kombinationsprodukt, kan efavirenz-dosis ikke ændres.
English: Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan:
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan indeholder
English: - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you only.
Danish: - Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.
English: Efavirenz/emtricitabine/tenofovir disoproxil must not be used in patients with severe hepatic impairment (see section 4.3) and is not recommended for patients with moderate hepatic impairment.
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil må ikke gives til patienter med svært nedsat leverfunktion (se pkt.
English: - if you are allergic to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan: - hvis De er allergisk over for efavirenz, emtricitabin, tenofovir, tenofovirdisoproxil eller et af de øvrige indholdsstoffer i efavirenz, emtricitabin, tenofovir, tenofovirdisoproxil (angivet i punkt
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10) Co-administration of atazanavir/ritonavir with tenofovir resulted in increased exposure to tenofovir.
Danish: AUC: ↓ 25% (↓ 42 til ↓ 3) Cmax: ↓ 28% (↓ 50 til ↑ 5) Cmin: ↓ 26% (↓ 46 til ↑ 10)
English: Age
Danish: Asteni
English: Efavirenz/emtricitabine/tenofovir disoproxil and valproic acid can be co-administered without dose adjustment.
Danish: Efavirenz/emtricitabin/tenofovirdi soproxil og valproat kan administreres samtidigt uden dosisjustering.
English: Efavirenz/emtricitabine/tenofovir disoproxil and raltegravir can be coadministered without dose adjustment.
Danish: Efavirenz/emtricitabin/tenofovirdi soproxil og fraltegravir kan administreres samtidigt uden dosisjustering.
English: MA (EU) number (Invented) name
Danish: MF (EU) nummer (Særnavn) Navn
English: Content (concentration)
Danish: Lægemiddelform Administration Emballage Indhold (koncentration)
English: 10 ml (30 mg/ml) 2 vials
Danish: Koncentrat ti infusionsvæske, opløsning
English: the condition of your liver.
Danish: tilstanden af din lever.
English: Patients in specific year with:
Danish: Patienter i specifikt år med:
English: Date of first authorisation: 26th September 2017
Danish: Dato for første markedsføringstilladelse: 26. september 2017
English: These patients should be followed closely.
Danish: Disse patienter skal monitoreres tæt.
English: Cumulative probability of:
Danish: Kumulativ sandsynlighed for:
English: This rare but serious side effect has occasionally been fatal.
Danish: Denne sjældne, men alvorlige bivirkning har i nogle tilfælde været dødelig.
English: ATC code: J05AF10
Danish: ATC-kode: J05AF10
English: Your dose will depend on:
Danish: Din dosis afhænger af:
English: Tell your doctor if you are pregnant or planning to become pregnant.
Danish: Fortæl det til lægen, hvis du er gravid, eller hvis du planlægger at blive gravid.
English: Age/gender:
Danish: Alder/køn:
English: The absolute bioavailability has not been determined.
Danish: Den absolutte biotilgængelighed er ikke bestemt.
English: Therefore, virological response should be closely monitored.
Danish: Virologisk respons bør derfor monitoreres omhyggeligt.
English: Severe Managed with CAPD
Danish: Svær behandlet med CAPD
English: Entecavir Accord with food and drink
Danish: Entecavir Accord sammen med mad og drikke
English: Protein binding to human serum protein in vitro is ≈ 13%.
Danish: Proteinbinding til humant serumprotein in vitro er ≈ 13%.
English: The optimal duration of treatment is unknown.
Danish: Den optimale behandlingsvarighed kendes ikke.
English: All 57 patients remained positive for HBsAg.
Danish: Alle 57 patienter forblev positive for HBsAg.
English: Tel: 0044 208 863 1427
Danish: Tlf: +44 208 863 1427
English: c Patients also have LVDr substitutions.
Danish: c Patienterne skal også have LVDr-substitutioner.
English: However, conclusions can only be drawn for the Caucasian and Asian groups as there were too few subjects in the other categories.
Danish: Der kan dog kun drages konklusioner for gruppen af europæisk og gruppen af asiatisk etnicitet, da der var for få patienter i de andre kategorier.
English: ULN=upper limit of normal, LLN=lower limit of normal.
Danish: ULN=øvre normalgrænse, LLN=nedre normalgrænse.
English: Results beyond 48 weeks of treatment:
Danish: Resultater efter 48 ugers behandling:
English: The proposed dose modifications are based on extrapolation of limited data, and their safety and effectiveness have not been clinically evaluated.
Danish: De foreslåede dosisændringer er baserede på en ekstrapolering af begrænsede data, og sikkerhed og effekt af disse er ikke klinisk evalueret.
English: Patients treated and monitored for resistance b
Danish: Patienter behandlet og monitoreret for resistens b
English: However, severe exacerbations, including fatalities, have been reported.
Danish: Der er dog indberettet svære eksacerbationer, inklusive død.
English: A micronucleus study and a DNA repair study in rats were also negative.
Danish: Et mikronukleus-studie og et DNA-reparationsstudie med rotter var ligeledes negative.
English: whether you have been treated for HBV infection before, and what medicine you received.
Danish: om du tidligere er behandlet for HBV-infektion, og hvilken medicin du fik.
English: whether you have kidney problems.
Danish: om du har nyreproblemer.
English: This medicinal product does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige opbevaringsbetingelser.
English: The randomization was stratified by age group (2 to 6 years; > 6 to 12 years; and > 12 to < 18 years).
Danish: Randomiseringen blev stratificeret efter aldersgruppe (2 til 6 år; > 6 til 12 år og > 12 til < 18 år).
English: Some people get very serious hepatitis symptoms when they stop taking Entecavir Accord.
Danish: Nogle mennesker får meget alvorlige leversymptomer, når de holder op med at tage Entecavir Accord.
English: Your child's doctor will decide the right dose based on your child's weight.
Danish: Barnets læge fastsætte den korrekte dosis ud fra barnets vægt.
English: Week 96 Week 48
Danish: Uge 96 Uge 48
English: All dosing will be taken once daily orally (by mouth).
Danish: Alle doseringer tages én gang dagligt oralt (igennem munden).
English: When your treatment with Entecavir Accord is stopped, your doctor will continue to monitor you and take blood tests for several months.
Danish: Hvis behandlingen med Entecavir Accord skal stoppes, vil din læge følge dig og tage blodprøver igennem flere måneder.
English: f Denominator is patients with abnormal values at baseline.
Danish: f Nævner for patienter med abnorme værdier ved baseline.
English: Entecavir should be used in these patients only if the potential benefit justifies the potential risk to the child (e.g. resistance).
Danish: Entecavir bør kun anvendes hos disse patienter, hvis den potentielle fordel retfærdiggør den potentielle risiko for barnet (f.eks. resistens).
English: Virological response should be frequently monitored in the lamivudine-refractory population and appropriate resistance testing should be performed.
Danish: Virologisk respons skal monitoreres hyppigt i den lamivudin-refraktære population, og der skal udføres relevant resistenstest.
English: The two trials provide resistance data in 183 patients treated and monitored in Year 1 and 180 patients treated and monitored in Year 2.
Danish: De to forsøg tilvejebringer resistensdata hos 183 patienter, der behandles og monitoreres i år 1, og 180 patienter, der behandles og monitoreres i år 2.
English: Frequency is defined as 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).
Danish: Hyppighed defineres som 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).
English: In most cases you may take Entecavir Accord with or without food.
Danish: De fleste kan tage Entecavir Accord med eller uden mad.
English: Treatment discontinuation may be considered as follows:
Danish: Seponering af behandling kan overvejes i følgende tilfælde:
English: Each carton contains either:
Danish: Hver æske indeholder enten:
English: Stable or improved CTP score b,d
Danish: Stabilt eller forbedret CTP-talb,d
English: If you are allergic to soya, do not use this medicinal product.
Danish: Hvis du er allergisk over for soja, må du ikke anvende dette lægemiddel.
English: HBeAg Negative (study 027)
Danish: HBeAg-negativ (studie 027)
English: Regardless of baseline characteristics, the majority of patients showed histological and virological responses to treatment.
Danish: Uafhængigt af baseline-karakteristika viste de fleste patienter histologisk og virologisk respons på behandling.
English: Pregnancy: there are no adequate data from the use of entecavir in pregnant women.
Danish: Graviditet: Der foreligger ikke tilstrækkelige data om brugen af entecavir hos gravide kvinder.
English: With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Danish: Ved længerevarende behandling igennem mere end 2 år, anbefales jævnlige revurderinger med henblik på at bekræfte, at den valgte behandling fortsat er relevant for patienten.
English: Some patients must take Entecavir Accord on an empty stomach (see Entecavir Accord with food and drink in Section 2).
Danish: Nogle patienter skal tage Entecavir Accord på tom mave (se Entecavir Accord sammen med mad og drikke i afsnit 2).
English: As entecavir is a nucleoside analogue, this risk cannot be excluded.
Danish: Da entecavir er et nukleosidanalog, kan denne risiko ikke udelukkes.
English: Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day.
Danish: Lægen kan vælge at give dig en lavere dosis eller vejlede dig i at tage medicinen mindre end en gang dagligt.
English: By 48 weeks of post-treatment follow-up, a substantial number of HBeAg negative patients lost response.
Danish: Ved 48 ugers opfølgning efter behandling tabte et betragteligt antal HBeAg-negative patienter respons.
English: Your doctor will advise you on the dose that is right for you.
Danish: Lægen vil rådgive dig om, hvilken dosis, der er bedst for dig.
English: Distribution: the estimated volume of distribution for entecavir is in excess of total body water.
Danish: Distribution: Det estimerede fordelingsvolumen for entecavir er større end kroppens totale vandindhold.
English: Gender and race: no dosage adjustment based on gender or race is required.
Danish: Køn og race: Dosisjustering er ikke nødvendig på baggrund af køn eller race.
English: Based on urinary excretion of unchanged drug, the bioavailability has been estimated to be at least 70%.
Danish: Baseret på urinudskillelsen af uomdannet lægemiddel, vurderes biotilgængeligheden at være mindst 70%.
English: In some cases, selection of HIV variant M184V has been observed, which has implications for the selection of HAART regimens that the patient may take in the future.
Danish: I nogle tilfælde er selektion af hiv-varianten M184V blevet observeret, som har implikation på valget af HAART-regimet, som patienten kan få i fremtiden.
English: Entecavir Accord reduces the amount of virus in your body, and improves the condition of the liver.
Danish: Entecavir Accord mindsker mængden af virus i kroppen og forbedrer leverens tilstand.
English: Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of resistance to treatment.
Danish: Tag altid den dosis, lægen anbefaler for at være sikker på, at medicinen virker helt som den skal og for at mindske udviklingen af resistens.
English: It is important that you do not miss any doses.
Danish: Det er vigtigt, at du ikke springer en dosis over.
English: The on-study cumulative death rate was 23% (23/102), and causes of death were generally liver-related, as expected in this population.
Danish: Den kumulative dødelighed i løbet af studiet var 23% (23/102), og dødsårsagerne var generelt lever-relaterede som forventet i denne population.
English: Post-treatment exacerbations are usually associated with rising HBV DNA, and the majority appears to be self-limited.
Danish: Eksacerbationer efter behandling er sædvanligvis forbundet med stigning i HBV-DNA, og størstedelen synes at være selvbegrænsende.
English: Gender: AUC was 14% higher in women than in men, due to differences in renal function and weight.
Danish: Køn: AUC var 14% højere hos kvinder end hos mænd på grund af forskellen i nyrefunktion og vægt.
English: e. Other special populations
Danish: e. Andre særlige populationer
English: if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor.
Danish: hvis du også har en hiv-infektion (humant immundefektvirus), skal du sørge for at fortælle det til din læge.
English: Patients who met virologic but not serologic or biochemical response criteria continued blinded treatment.
Danish: Patienter, som opfyldte virologiske, men ikke serologiske eller biokemiske responskriterier, fortsatte blindet behandling.
English: - emerging genotypic ETVr c
Danish: - opståen af genotype-ETVr c
English: Therefore CYP450 mediated drug interactions are unlikely to occur with entecavir.
Danish: CYP450-medierede lægemiddelinteraktioner med entecavir er derfor ikke sandsynlige.
English: The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBV
Danish: Sikkerhed og virkning af entecavir blev også undersøgt i et aktivt kontrolleret klinisk forsøg med 191 HBV
English: A 4 hour period of haemodialysis removed ≈ 13% of the dose, and 0.3% was removed by CAPD.
Danish: En 4 timers hæmodialyseperiode fjernede ≈ 13% af dosis, og 0,3% blev fjernet ved CAPD.
English: rare (at least 1 in 10,000 patients): severe allergic reaction.
Danish: sjældne (forekommer hos mellem 1 og 10 ud af 10.000 patienter): alvorlig allergisk reaktion.
English: If your liver disease is very advanced, your doctor will also instruct you to take Entecavir Accord on an empty stomach.
Danish: Hvis din leversygdom er meget fremskreden, vil lægen ligeledes vejlede dig i, at du skal tage Entecavir Accord på tom mave.
English: Treatment beyond 48 weeks: continued treatment with entecavir for a median duration of 96 weeks did not reveal any new safety signals.
Danish: Behandling ud over 48 uger: Fortsat behandling med entecavir, med en gennemsnitlig varighed på 96 uger, har ikke rejst nye sikkerhedsspørgsmål.
English: Your doctor will monitor you regularly while you are receiving Entecavir Accord.
Danish: Lægen vil jævnligt kontrollere dig, mens du tager Entecavir Accord.
English: During Year 2, genotypic resistance to ETV was detected in 2 patients (1.1% cumulative probability of resistance through Year 2).
Danish: I år 2 blev genotyperesistens over for ETV detekteret hos 2 patienter (1,1% kumulativ sandsynlighed for resistens i år 2).
English: If overdose occurs, the patient must be monitored for evidence of toxicity and given standard supportive treatment as necessary.
Danish: I tilfælde af overdosis skal patienten monitoreres for tegn på toksicitet og gives understøttende standardbehandling efter behov.
English: There are no data on the effect of entecavir on transmission of HBV from mother to newborn infant.
Danish: Der er ingen data vedrørende effekt af entecavir på overførsel af HBV fra mor til nyfødt.
English: MELD score Mean change from baselinec,e
Danish: MELD-score Gennemsnitlig ændring fra baselinec,e
English: However, the no effect levels could not be precisely established.
Danish: Det er dog ikke muligt at bestemme præcise nul-effektniveauer.
English: Not all pack sizes and container types may be marketed.
Danish: Ikke alle pakningsstørrelser og beholdertyper er nødvendigvis markedsført.
English: Entecavir Accord will not control your HIV infection.
Danish: Entecavir Accord vil ikke kontrollere din hiv-infektion.
English: Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
Danish: Der bør derfor interveneres på relevant vis for at forhindre neonatal erhvervelse af HBV.
English: Periodic monitoring of hepatic function is recommended during treatment.
Danish: Periodisk monitorering af leverfunktion anbefales under behandling.
English: Emerging entecavir resistance in lamivudine-refractory studies through Week 240 is summarized in the table.
Danish: Opståen af entecavirresistens i lamivudinrefraktære studier til og med Uge 240 opsummeres i tabellen.
English: The on-study cumulative rate of hepatocellular carcinoma (HCC) was 12% (12/102).
Danish: Den kumulative forekomst af carcinoma hepatocellulare (HCC) i løbet af studiet var 12% (12/102).
English: An oral solution may be available for patients with body weight less than 32.6 kg.
Danish: Der kan fås en oral opløsning til patienter med en kropsvægt under 32,6 kg.
English: Children and adolescents (from 2 to less than 18 years of age) can take Entecavir Accord with or without food.
Danish: Børn og unge (fra 2-18 år) kan tage Entecavir Accord med eller uden mad.
English: Serious adverse events were generally liver-related, with an on-study cumulative frequency of 69%.
Danish: Alvorlige bivirkninger var generelt lever-relaterede med en kumulativ forekomst i studiet på 69%.
English: Haemodialysis or CAPD**
Danish: Hæmodialyse eller CAPD**
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Each carton contains one bottle.
Danish: Hver æske indeholder én beholder.
English: After adjusting for differences in creatinine clearance and body weight there was no difference in exposure between male and female subjects.
Danish: Efter justering for forskelle i kreatinin-clearance og kropsvægt var der ingen forskel i optagelse hos kvindelige og mandlige patienter.
English: No testicular changes were evident in a 1-year study in monkeys.
Danish: Der sås ingen testikelforandringer i et 1-årigt studie med aber.
English: Nucleoside naïve patients
Danish: Nukleosid-naive patienter
English: virus (HBV) through sexual contact or body fluids (including blood contamination).
Danish: (HBV) gennem seksuel kontakt eller kropsvæsker (fx blod).
English: e ETVr occurring in any year; virologic breakthrough in specified year.
Danish: e ETVr der forekommer i et givent år, virologisk svigt i det specificerede år.
English: AUC was 29% higher in elderly than in young subjects, mainly due to differences in renal function and weight.
Danish: AUC var 29% højere hos ældre end hos yngre patienter, primært på grund af forskelle i nyrefunktion og vægt.
English: Your doctor will tell you if and when you should stop the treatment.
Danish: Lægen vil give dig besked om, hvorvidt du skal afslutte behandingen, og hvornår du skal afslutte behandlingen.
English: If you forget to take Entecavir Accord
Danish: Hvis du har glemt at tage Entecavir Accord
English: The decision to treat paediatric patients should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information.
Danish: Beslutningen om at behandle pædiatriske patienter bør være baseret på en omhyggelig vurdering af den enkelte patients behov og i henhold til gældende retningelinjer for pædiatrisk behandling, herunder histologiske oplysninger ved baseline.
English: In accordance with current paediatric practice guidelines, treatment discontinuation may be considered as follows:
Danish: I henhold til gældende retningslinjer for pædiatrisk behandling bør seponering af behandlingen overvejes i følgende tilfælde:
English: General: patients should be advised that therapy with entecavir has not been proven to reduce the risk of transmission of HBV and therefore appropriate precautions should still be taken.
Danish: Generelt: Patienterne skal informeres om, at det ikke er påvist, at behandling med entecavir mindsker risikoen for overførsel af HBV, og at der derfor fortsat skal tages relevante forholdsregler.
English: Results for selected study endpoints at weeks 24 and 48 are shown in the table.
Danish: Resultaterne for udvalgte endepunkter fra studiets uge 24 og 48 er vist i tabellen.
English: Patients who did not have a virologic response were offered alternative treatment.
Danish: Patienter, som ikke havde virologisk respons, blev tilbudt anden behandling.