FrancophonIA/ELRC3.0 huggingface dataset:
English: • antiviral medicines used to treat HIV, such as:
Danish: • antivirale lægemidler, der anvendes til behandling af hiv, såsom:
English: Keep the bottle tightly closed.
Danish: Beholderen skal holdes tæt tillukket.
English: • Talk to your doctor if you also have HIV.
Danish: • Tal med lægen, hvis du også har hiv.
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100).
Danish: Hyppigheden er defineret på følgende måde: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) eller ikke almindelig (≥ 1/1.000 til < 1/100).
English: Exacerbation of hepatitis
Danish: Forværring af hepatitis
English: This may stop your medicines from working properly, or may make any side effects worse.
Danish: Det kan forhindre, at lægemidlerne virker korrekt, eller det kan gøre eventuelle bivirkninger værre.
English: You must use an effective method of contraception.
Danish: Du skal bruge et effektivt præventionsmiddel.
English: The most frequently reported adverse reactions were headache (12%), nausea (6%), and fatigue (6%).
Danish: De hyppigst rapporterede bivirkninger var hovedpine (12 %), kvalme (6 %) og træthed (6 %).
English: Discuss with your doctor the precautions needed to avoid infecting others.
Danish: Tal med lægen om, hvad du skal gøre for at undgå at smitte andre.
English: HBV transmission
Danish: Overførsel af HBV
English: Patients with decompensated liver disease
Danish: Patienter med dekompenseret leversygdom
English: Missing data during window but on study drug
Danish: Manglende data i vinduet, men får studielægemidlet
English: Tests may also show: • Increased level of a liver enzyme (ALT) in the blood
Danish: Prøver kan også vise: • Forhøjet indhold af et leverenzym (ALAT) i blodet
English: Patients with creatinine clearance < 30 mL/min
Danish: Patienter med kreatininclearance < 30 ml/min
English: Table 1: Interactions between Vemlidy and other medicinal products
Danish: Tabel 1: Interaktion mellem Vemlidy og andre lægemidler
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på beholderen og pakningen efter {EXP}.
English: • Swelling of the face, lips, tongue or throat (angioedema)
Danish: • Hævelse af ansigt, læber, tunge eller hals (angioødem)
English: Study 110 (HBeAg-Positive)
Danish: Studie 110 (HBeAg-positiv)
English: • Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Danish: • Fortæl straks lægen om nye eller usædvanlige symptomer, efter du er holdt op med behandlingen, især symptomer, som du forbinder med hepatitis B-infektion.
English: Treatment of overdose with Vemlidy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Danish: Behandling af overdosering af Vemlidy består af generel understøttende behandling, herunder monitorering af vitale tegn og observation af patientens kliniske status.
English: • if you are allergic to tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for tenofovir-alafenamid eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: The adverse reactions are listed below by body system organ class and frequency based on the Week 96 analysis.
Danish: Bivirkningerne er anført efter systemorganklasse og hyppighed baseret på analysen i uge 96.
English: Age, gender and ethnicity
Danish: Alder, køn og etnisk baggrund
English: Study 108 (HBeAg-Negative)
Danish: Studie 108 (HBeAg-negativ)
English: After initiating antiviral therapy, serum ALT may increase in some patients.
Danish: Efter påbegyndelse af antiviral terapi kan serum-ALAT stige hos visse patienter.
English: Liver flares are especially serious, and sometimes fatal in patients with decompensated liver disease.
Danish: Opblussen af leversygdom er særligt alvorlig og nogle gange dødelig for patienter med dekompenseret leversygdom.
English: Do not take Vemlidy with other medicines containing:
Danish: Tag ikke Vemlidy sammen med andre lægemidler, der indeholder:
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: I længerevarende behandlingsforløb (over 2 år) anbefales regelmæssig evaluering med henblik på at bekræfte, at fortsættelse af den valgte behandling er hensigtsmæssig for patienten.
English: Therefore, hepatobiliary and renal parameters should be closely monitored in this patient population (see section 5.2).
Danish: Derfor skal hepatobiliære og renale parametre monitoreres nøje hos denne patientpopulation (se pkt.
English: Differences in pharmacokinetics according to gender were not considered to be clinically relevant.
Danish: Farmakokinetiske forskelle i henhold til køn blev ikke anset for at være klinisk relevante.
English: (may affect up to 1 in 100 people)
Danish: (kan berøre op til 1 ud af 100 personer)
English: If you accidentally take more than the recommended dose of Vemlidy you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Danish: Hvis du ved et uheld har taget mere end den anbefalede dosis af Vemlidy, kan du have større risiko for at få bivirkninger af dette lægemiddel (se afsnit 4, Bivirkninger).
English: If you are not sure whether you have HIV, your doctor should offer you HIV testing before you start taking Vemlidy for hepatitis B.
Danish: Hvis du ikke er sikker på, om du har hiv, bør din læge tilbyde dig en hiv-test, før du begynder at tage Vemlidy mod hepatitis B.
English: Recommendation concerning co-administration with Vemlidy
Danish: Anbefaling vedrørende administration sammen med Vemlidy
English: Vemlidy film-coated tablets should be taken with food.
Danish: Vemlidy filmovertrukne tabletter skal tages sammen med mad.
English: Vemlidy has no or negligible influence on the ability to drive and use machines.
Danish: Vemlidy påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: After Week 96, patients either remained on their original blinded treatment or received open-label Vemlidy.
Danish: Efter uge 96 forblev patienter enten på deres oprindelige blindede behandling eller fik ikke-blindet Vemlidy.
English: Medicines used in treating hepatitis B infection
Danish: Lægemidler, der bruges til behandling af hepatitis B-infektion
English: Treatment outcomes of Study 108 and Study 110 through Week 48 are presented in Table 3 and Table 4.
Danish: Behandlingsresultater for Studie 108 og Studie 110 til og med uge 48 er vist i tabel 3 og tabel 4.
English: A risk to the breast-fed newborns/infants cannot be excluded; therefore, Vemlidy should not be used during breast-feeding.
Danish: En risiko for de ammede nyfødte/spædbørn kan ikke udelukkes, og Vemlidy må derfor ikke anvendes under amning.
English: The mechanism of tumour formation in mice and potential relevance for humans is uncertain.
Danish: Mekanismen bag udvikling af tumorer hos mus og den mulige relevans for mennesker er uvis.
English: (may affect more than 1 in 10 people) • Headache
Danish: (kan berøre flere end 1 ud af 10 personer) • Hovedpine
English: • Talk to your doctor before you stop taking Vemlidy for any reason, particularly if you are experiencing any side effects or you have another illness.
Danish: • Tal med lægen, inden du holder op med at tage Vemlidy uanset årsag, især hvis du har oplevet bivirkninger, eller hvis du har en anden sygdom.
English: EU/1/16/1154/001 30 film-coated tablets EU/1/16/1154/002 90 (3 bottles of 30) film-coated tablets
Danish: EU/1/16/1154/001 30 filmovertrukne tabletter EU/1/16/1154/002 90 (3 beholdere med 30) filmovertrukne tabletter
English: It is not an inhibitor or inducer of CYP3A in vivo.
Danish: Det hæmmer eller inducerer ikke CYP3A in vivo.
English: Other types of medicines
Danish: Andre typer af lægemidler
English: Your doctor may need to carry out blood tests to monitor your liver function.
Danish: Det kan være, at din læge vil tage blodprøver for at holde øje med din leverfunktion.
English: Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Danish: Studier af reproduktionstoksicitet hos rotter og kaniner viste ingen negative virkninger hverken på parrings-, fertilitets-, graviditets- eller fosterparametre.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (færre end 300 gravide studiepersoner) fra anvendelse af tenofoviralafenamid til gravide kvinder.
English: • Talk to your doctor if you also have hepatitis C or D. Vemlidy has not been tested on patients who have hepatitis C or D as well as hepatitis B.
Danish: • Tal med lægen, hvis du også har hepatitis C eller D. Vemlidy er ikke blevet undersøgt hos patienter, som har hepatitis C eller D udover hepatitis B.
English: (may affect up to 1 in 10 people)
Danish: (kan berøre op til 1 ud af 10 personer)
English: Patients with liver disease, who are treated for hepatitis B with antiviral medicines, have a higher risk of severe and potentially fatal liver complications.
Danish: Patienter med leversygdom, som behandles for hepatitis B med antivirale lægemidler, har større risiko for alvorlige og muligvis dødelige komplikationer fra leveren.
English: In some patients with advanced liver disease or cirrhosis, this could be life-threatening.
Danish: Hos nogle patienter med fremskreden leversygdom eller skrumpelever (cirrose) kan det være livstruende.
English: Regular reassessment is recommended after treatment discontinuation to detect virological relapse.
Danish: Regelmæssig evaluering anbefales efter behandlingsophør med henblik på detektion af virologisk relaps.
English: Oxcarbazepine Phenobarbital
Danish: Oxcarbazepin Phenobarbital
English: ritonavir or cobicistat boosted darunavir, lopinavir or atazanavir
Danish: ritonavir- eller cobicistat-boosted darunavir, lopinavir eller atazanavir
English: In analyses at Week 48 (N = 20) and Week 96 (N = 72), no amino acid substitutions associated with resistance to Vemlidy were identified in these isolates (genotypic and phenotypic analyses).
Danish: I analyser i uge 48 (n=20) og uge 96 (n=72), blev der ikke identificeret nogen aminosyresubstitutioner associeret med resistens over for Vemlidy i disse isolater (genotype- og fænotypeanalyser).
English: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum alanine aminotransferase (ALT).
Danish: Spontane eksacerbationer af kronisk hepatitis B er relativt almindelige og kendetegnes ved forbigående stigning i serum-alaninaminotransferase (ALAT).
English: The primary efficacy endpoint in both studies was the proportion of patients with plasma HBV DNA levels below 29 IU/mL at Week 48.
Danish: Det primære effektmål i begge studier var andelen af patienter med plasma-HBV-DNA under 29 IE/ml i uge 48.
English: If you stop taking Vemlidy, you will need regular health checks and blood tests for several months to check your hepatitis B infection.
Danish: Hvis du holder op med at tage Vemlidy, skal du regelmæssigt have foretaget helbredsundersøgelser og have taget blodprøver i flere måneder som kontrol af din hepatitis B-infektion.
English: Adults and adolescents (aged 12 years and older with body weight at least 35 kg): one tablet once daily.
Danish: Voksne og unge (i alderen 12 år og derover med en legemsvægt på mindst 35 kg): én tablet én gang dagligt.
English: Table 4: Additional efficacy parameters at Week 48a
Danish: Tabel 4: Yderligere effektparametre i uge 48a
English: At Week 96, viral suppression as well as biochemical and serological responses were maintained with continued tenofovir alafenamide treatment (see Table 5).
Danish: I uge 96 blev virologisk suppression samt biokemisk og serologisk respons opretholdt ved fortsat behandling med tenofoviralafenamid (se tabel 5).
English: The majority of cases are self-limited but severe exacerbations, including fatal outcomes, may occur after discontinuation of treatment for hepatitis B. Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of treatment for hepatitis B. If appropriate, resumption of hepatitis B therapy may be warranted.
Danish: Størstedelen af tilfældene var selvbegrænsende, men alvorlige eksacerbationer, herunder med dødelig udgang, kan forekomme efter ophør af behandling for hepatitis B. Leverfunktionen skal monitoreres med jævne intervaller med såvel klinisk som laboratoriemæssig opfølgning i mindst 6 måneder efter ophør af hepatitis Bbehandling.
English: • Talk to your doctor before you restart taking Vemlidy tablets.
Danish: • Tal med lægen, før du begynder at tage Vemlidy-tabletter igen.
English: If you feel dizzy when taking Vemlidy, do not drive and do not use any tools or machines.
Danish: Hvis du føler dig svimmel, mens du tager Vemlidy, må du ikke føre motorkøretøj eller bruge værktøj eller maskiner.
English: HIV ANTIRETROVIRAL AGENTS - CCR5 RECEPTOR ANTAGONIST Maraviroc
Danish: ANTIRETROVIRALE MIDLER MOD HIV - CCR5-RECEPTORANTAGONIST Maraviroc
English: Non-clinical studies in rats and dogs revealed bone and kidney as the primary target organs of toxicity.
Danish: Prækliniske studier hos rotter og hunde viste, at knogler og nyrer er de primære målorganer for toksicitet.
English: Patients should be informed that dizziness has been reported during treatment with Vemlidy.
Danish: Patienten skal informeres om, at der er rapporteret svimmelhed under behandling med Vemlidy.
English: Pharmacotherapeutic group: Antiviral for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors; ATC code: J05AF13.
Danish: Farmakoterapeutisk klassifikation: Antiviralt middel til systemisk brug, nukleosid og nukleotid revers transkriptasehæmmere, ATC-kode: J05AF13.
English:  Tell your doctor if you are taking these or any other medicines.
Danish:  Fortæl det til lægen, hvis du tager et eller flere af disse lægemidler, eller hvis du tager andre lægemidler.
English: The binding of tenofovir to human plasma proteins is less than 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
Danish: Bindingen af tenofovir til humane plasmaproteiner er mindre end 0,7 % og er koncentrationsuafhængig i intervallet 0,01-25 μg/ml.
English: Normalised ALT (AASLD)c
Danish: Normaliseret ALAT (AASLD)c
English: The drug interactions described are based on studies conducted with tenofovir alafenamide, or are potential drug interactions that may occur with Vemlidy.
Danish: De beskrevne lægemiddelinteraktioner er baseret på studier udført med tenofoviralafenamid eller er lægemiddelinteraktioner, der muligvis kan forekomme med Vemlidy.
English: 90 (3 bottles of 30) film-coated tablets.
Danish: 90 (3 beholdere med 30) filmovertrukne tabletter.
English: It is important not to miss a dose of Vemlidy.
Danish: Det er vigtigt ikke at glemme en dosis af Vemlidy.
English: As a result, the amounts of Vemlidy or other medicines in your blood may change.
Danish: Det kan betyde en ændring i mængden af Vemlidy eller andre lægemidler i dit blod.
English: If you forget to take Vemlidy
Danish: Hvis du har glemt at tage Vemlidy
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Danish: Følgende pakningsstørrelser fås: kartonæske med 1 beholder med 30 filmovertrukne tabletter og kartonæske med 3 beholdere med 30 (90) filmovertrukne tabletter.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
Danish: Hvis overdosering forekommer, skal patienten overvåges for tegn på toksicitet (se pkt.
English: No human data on the effect of Vemlidy on fertility are available.
Danish: Der foreligger ingen humane data om Vemlidys indvirkning på fertiliteten.
English: • Talk to your doctor or pharmacist if you have had kidney disease or if tests have shown problems with your kidneys.
Danish: • Tal med lægen eller apotekspersonalet, hvis du har haft en nyresygdom, eller hvis prøver har vist, at du har problemer med nyrerne.
English: A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumours, considered likely related to high local concentrations in the gastrointestinal tract at the high dose of 600 mg/kg/day.
Danish: Et langvarigt oralt karcinogenicitetsstudie hos mus viste en lav forekomst af duodenale tumorer, hvor det antages, at det sandsynligvis skyldes de høje lokale koncentrationer i mave-tarm-kanalen ved den høje dosis på 600 mg/kg/dag.
English: Tenofovir has activity that is specific to hepatitis B virus and human immunodeficiency virus (HIV-1 and HIV-2).
Danish: Tenofovir har aktivitet, som er specifik for hepatitis B-virus og humant immundefektvirus (hiv 1 og hiv 2).
English: b Adjusted by baseline plasma HBV DNA categories and oral antiviral treatment status strata.
Danish: b. Justeret for plasma-HBV-DNA-kategorier ved baseline samt strata af status for oral antiviral behandling.
English: The use of Vemlidy once daily in patients with CrCl ≥ 15 mL/min but < 30 mL/min and in patients with CrCl < 15 mL/min who are receiving haemodialysis is based on very limited pharmacokinetic data and on modelling and simulation.
Danish: Anvendelse af Vemlidy én gang dagligt hos patienter med CrCl ≥ 15 ml/min, men < 30 ml/min, og hos patienter med CrCl < 15 ml/min, som er i hæmodialyse, er baseret på meget begrænsede farmakokinetiske data samt på modellering og simulering.
English: Tenofovir alafenamide and tenofovir have a median plasma half-life of 0.51 and 32.37 hours, respectively.
Danish: Tenofoviralafenamid og tenofovir har en median plasma-halveringstid på henholdsvis 0,51 og 32,37 timer.
English: In patients with hepatitis B, Vemlidy controls the infection by stopping the virus from multiplying.
Danish: Hos patienter med hepatitis B kontrollerer Vemlidy infektionen ved at hindre, at virus formerer sig.
English: Renal excretion of intact tenofovir alafenamide is a minor pathway with < 1% of the dose eliminated in urine.
Danish: Renal udskillelse af uomdannet tenofoviralafenamid er en mindre betydningsfuld metaboliseringsvej med < 1 % af dosen elimineret i urinen.
English: Tenofovir alafenamide exposures are dose proportional over the dose range of 8 to 125 mg.
Danish: Tenofoviralafenamid-eksponeringen er proportional med dosis i dosisintervallet 8 til 125 mg.
English: Diarrhoea, vomiting, nausea, abdominal pain, abdominal distension, flatulence Hepatobiliary disorders
Danish: Diarré, opkastning, kvalme, abdominalsmerter, abdominal udspiling, flatulens
English: Co-administration guidance for the treatment of hepatitis C should be followed (see section 4.5).
Danish: Retningslinjerne for samtidig administration ved behandling af hepatitis C skal følges (se pkt.
English: The mean age was 38 years, 64% were male, 82% were Asian, 17% were White and < 1% (5 subjects) were Black.
Danish: Gennemsnitsalderen var 38 år, 64 % var mænd, 82 % var asiater, 17 % var hvide, og < 1 % (5 patienter) var sorte.
English: Tenofovir alafenamide is transported by P-gp and breast cancer resistance protein (BCRP).
Danish: Tenofoviralafenamid transporteres af P-gp og brystcancer-resistent protein (BCRP).
English: ANTIFUNGALS Itraconazole Ketoconazole
Danish: ANTIMYKOTIKA Itraconazol Ketoconazol
English: Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxic assays.
Danish: Tenofoviralafenamid var ikke mutagent eller klastogent i konventionelle genotoksicitets-assays.
English: Animal studies do not indicate harmful effects of tenofovir alafenamide on fertility.
Danish: Dyrestudier indikerer ingen skadelige virkninger af tenofoviralafenamid på fertiliteten.
English: In patients who are co-infected with HBV and HIV, Vemlidy should be co-administered with other antiretroviral agents to ensure that the patient receives an appropriate regimen for treatment of HIV (see section 4.5).
Danish: Hos patienter med samtidig HBV- og hivinfektion skal Vemlidy administreres sammen med andre antiretrovirale midler for at sikre, at patienten får et velegnet regime til behandling af hiv (se pkt.
English:  If any of these apply to you, talk to your doctor before taking Vemlidy.
Danish:  Hvis noget af dette gælder for dig, skal du tale med lægen, før du tager Vemlidy.
English: Table 5: HBV DNA and additional efficacy parameters at Week 96a
Danish: Tabel 5: HBV-DNA og yderligere effektparametre i uge 96a
English: The efficacy and safety of Vemlidy in patients with chronic hepatitis B are based on 48- and 96-week data from two randomised, double-blind, active-controlled studies, GS-US-320-0108 (“Study 108”) and GS-US-320-0110 (“Study 110”).
Danish: Vemlidys sikkerhed og virkning hos patienter med kronisk hepatitis B er baseret på 48 og 96 ugers data fra to randomiserede, dobbeltblinde, aktivt kontrollerede studier, GS-US-320-0108 („Studie 108“) og GS-US-320-0110 („Studie 110“).
English:  If this applies to you, do not take Vemlidy and tell your doctor immediately.
Danish:  Hvis dette gælder for dig, må du ikke tage Vemlidy, og du skal straks fortælle det til lægen.
English: In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Danish: Hos patienter med kompenseret leversygdom ledsages disse stigninger i serum-ALAT generelt ikke af en stigning i serumbilirubin eller hepatisk dekompensation.
English: However, in animal studies it has been shown that tenofovir is secreted into milk.
Danish: Dyrestudier har imidlertid vist, at tenofovir udskilles i mælk.
English: In patients with severe hepatic impairment, total plasma concentrations of tenofovir alafenamide and tenofovir are lower than those seen in subjects with normal hepatic function.
Danish: Hos patienter med svært nedsat leverfunktion er de totale plasmakoncentrationer af tenofoviralafenamid og tenofovir lavere end dem, der ses hos patienter med normal leverfunktion.
English: Patients must be advised that Vemlidy does not prevent the risk of transmission of HBV to others through sexual contact or contamination with blood.
Danish: Patienten skal rådgives om, at behandling med Vemlidy ikke udelukker, at der er en risiko for at overføre HBV til andre gennem seksuel kontakt eller kontaminering med blod.
English: Central laboratory ULN for ALT are as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males ≥ 69 years; ≤ 34 U/L for females 18 to < 69 years and ≤ 32 U/L for females ≥ 69 years.
Danish: Centrallaboratoriets ULN for ALAT er følgende: ≤ 43 E/l for mænd i alderen 18 til < 69 år og ≤ 35 E/l for mænd ≥ 69 år; ≤ 43 E/l for kvinder i alderen 18 til < 69 år og ≤ 32 E/l for kvinder ≥ 69 år.
English: The mean age was 46 years, 61% were male, 72% were Asian, 25% were White and 2% (8 subjects) were Black.
Danish: Gennemsnitsalderen var 46 år, 61 % var mænd, 72 % var asiater, 25 % var hvide, og 2 % (8 patienter) var sorte.
English: Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
Danish: Patienter med cirrose kan have en større risiko for hepatisk dekompensation efter hepatitis-eksacerbation og skal derfor monitoreres nøje under behandlingen.
English: Vemlidy [Outer packaging only]
Danish: Vemlidy [Kun ydre emballage]
English: Relative to fasting conditions, the administration of a single dose of Vemlidy with a high fat meal resulted in a 65% increase in tenofovir alafenamide exposure.
Danish: I forhold til fastende tilstand resulterede administration af en enkelt dosis Vemlidy sammen med et meget fedtholdigt måltid i en stigning på 65 % i eksponeringen for tenofoviralafenamid.