FrancophonIA/ELRC3.0 huggingface dataset:
English: Emtricitabine: Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.
Danish: Emtricitabin: Prækliniske data for emtricitabin viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: No clinically important pharmacokinetic difference due to ethnicity has been identified for emtricitabine.
Danish: Der er ikke blevet identificeret klinisk vigtige farmakokinetiske forskelle på grund af etnicitet for emtricitabin.
English: diarrhoea, nausea diarrhoea, vomiting, nausea
Danish: diarré, kvalme diarré, opkastning, kvalme
English: Pre-exposure prophylaxis (PrEP):
Danish: Profylakse før eksponering (Pre-exposure prophylaxis, PrEP):
English: • If you have hepatitis B, it is especially important not to stop your treatment with Emtricitabine/Tenofovir disoproxil Mylan without talking to your doctor first.
Danish: • Hvis De har hepatitis B, er det særlig vigtigt ikke at ophøre med behandlingen med Emtricitabine/Tenofovir disoproxil Mylan uden først at konsultere Deres læge.
English: Synergistic antiviral activity was observed with the combination of emtricitabine and tenofovir in vitro.
Danish: Synergistisk antiviral aktivitet sås med kombinationen af emtricitabin og tenofovir in vitro.
English: Genotoxicity studies revealed positive results in the in vitro mouse lymphoma assay, equivocal results in one of the strains used in the Ames test, and weakly positive results in an UDS test in primary rat hepatocytes.
Danish: Studier af genotoksicitet viste positive resultater i in vitro-muselymfomanalysen, uklare resultater for en af de stammer, der blev anvendt i Ames-testen, og svagt positive resultater i UDS-testen i primære rottehepatocytter.
English: Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Danish: Efter peroral indgivelse er tenofovirs eliminationshalveringstid ca. 12 til 18 timer.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Danish: Hos nogle patienter med fremskreden HIV-infektion (AIDS) og tidligere tilfælde af opportunistiske infektioner (infektioner, der optræder hos mennesker med et svagt immunforsvar), kan der forekomme tegn og symptomer på inflammation fra tidligere infektioner kort efter, at behandlingen for HIV er startet.
English: Possible serious side effects:
Danish: Alvorlige bivirkninger:
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil.
Danish: En stor mængde data fra gravide kvinder (mere end 1.000 graviditetsudfald) indikerer ingen misdannelser eller føtal/neonatal toksicitet i forbindelse med emtricitabin og tenofovirdisoproxil.
English: ** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count TLOVR = Time to Loss of Virologic
Danish: ** p-værdien baseret på Cochran-Mantel-Haenszel-testen stratificeret til CD4-celletal ved baseline TLOVR = Time to Loss of Virologic Response (tiden til tab af virologisk respons) a: Van Elteren-test
English: • Although there are limited clinical data on the use of emtricitabine/Tenofovir disoproxil in pregnant women, it is not usually used unless absolutely necessary.
Danish: • Selvom der foreligger begrænsede kliniske data om brug af emtricitabin/tenofovirdisoproxil hos gravide, anvendes emtricitabin/tenofovirdisoproxil normalt ikke, medmindre det er absolut nødvendigt.
English: • difficulty sleeping, abnormal dreams
Danish: • søvnløshed, unormale drømme
English: Adherence Substudy Participantsb Placebo
Danish: Deltagere i adhærensdelstudietb Placebo
English: In vitro studies have determined that neither tenofovir disoproxil nor tenofovir are substrates for the CYP450 enzymes.
Danish: In vitro-studier har afgjort, at hverken tenofovirdisoproxil eller tenofovir er substrater for CYP450-enzymerne.
English: Table 2: Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products
Danish: Tabel 2: Interaktion mellem emtricitabin/tenofovirdisoproxil eller dets individuelle komponent(er) og andre lægemidler
English: Emtricitabine/tenofovir disoproxil should only be used in individuals with creatinine clearance (CrCl) <80 mL/min if the potential benefits are considered to outweigh the potential risks.
Danish: Emtricitabin/tenofovirdisoproxil bør kun anvendes hos personer med kreatininclearance (CrCl) <80 ml/min, hvis de potentielle fordele anses for at opveje de potentielle risici.
English: • Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect.
Danish: • Laktatacidose (for meget mælkesyre i blodet) er en sjælden bivirkning, som kan være livstruende.
English: Ask your doctor if you have any more questions about how to prevent getting HIV or spreading HIV to other people.
Danish: Spørg Deres læge, hvis De har flere spørgsmål om, hvordan De kan undgå at få HIV eller sprede HIV til andre mennesker.
English: Therefore, the same problems may be seen if emtricitabine/tenofovir disoproxil is administered with a third nucleoside analogue.
Danish: De samme problemer kan derfor muligvis optræde, hvis emtricitabin/tenofovirdisoproxil administreres sammen med en tredje nukleosidanalog.
English: Damage to kidney tubule cells may be associated with breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood.
Danish: Skade på tubulære celler i nyrerne kan være forbundet med nedbrydning af muskelvæv, blødgøring af knogler (med knoglesmerter og af og til med knoglebrud til følge), muskelsmerter, muskelsvaghed og nedsat indhold af kalium eller fosfat i blodet.
English: In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor.
Danish: I andre studier (prospektive og tværgående) sås de mest udtalte fald i BMD hos patienter, som fik tenofovirdisoproxil som del af et regime, der indeholdt en boostet proteasehæmmer.
English: At baseline the randomised groups had similar median plasma HIV-1 RNA (5.02 and 5.00 log10 copies/mL) and CD4 counts (233 and 241 cells/mm3).
Danish: Ved baseline havde de randomiserede grupper nogenlunde samme mediane plasma HIV 1-rna (5,02 og 5,00 log10 kopier/ml) og CD4-tal (233 og 241 celler/mm3).
English: 2 The predominant circulating metabolite of sofosbuvir.
Danish: 2 Den primære cirkulerende sofosbuvirmetabolit.
English: Late onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Danish: Sent forekommende neurologiske forstyrrelser er i sjældne tilfælde blevet rapporteret (hypertoni, kramper, unormal adfærd).
English: Oral carcinogenicity studies in rats and mice only revealed a low incidence of duodenal tumours at an extremely high dose in mice.
Danish: Orale karcinogenicitetsstudier hos rotter og mus viste kun en lav forekomst af duodenaltumorer ved en ekstremt høj dosis givet til mus.
English: Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Danish: Fund ved studier med rotter og aber viste, at der var en stofrelateret reduktion i den intestinale absorption af fosfat med potentiel, sekundær reduktion af BMD.
English: Repeated dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use include renal and bone toxicity and a decrease in serum phosphate concentration.
Danish: Resultater fra studier af toksicitet efter gentagne doser hos rotter, hunde og aber ved eksponeringsniveauer højere end eller lig med kliniske eksponeringsniveauer og med mulig relevans for klinisk anvendelse omfatter nyre- og knogletoksicitet og et fald i serum-phosphatkoncentrationen.
English: The difference in the proportion of patients who maintained < 400 copies/mL at week 48 was mainly influenced by the higher number of discontinuations in the tenofovir disoproxil treatment group.
Danish: Forskellen i andelen af patienter, der fortsat havde < 400 kopier/ml i uge 48, skyldtes hovedsageligt, at flere seponerede behandlingen i gruppen, der fik tenofovirdisoproxil.
English: It is not known whether emtricitabine or tenofovir can be removed by peritoneal dialysis.
Danish: Det vides ikke, om emtricitabin eller tenofovir kan fjernes ved peritonealdialyse.
English: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 mL/min/1.73 m2.
Danish: 7 patienter havde en estimeret glomerulær filtrationshastighed (GFR) mellem 70 og 90 ml/min/1,73 m².
English: Among them, 3 patients experienced a clinically meaningful decline in estimated GFR during therapy which improved after discontinuation of tenofovir disoproxil.
Danish: Under behandlingen oplevede tre af disse patienter et klinisk betydningsfuldt fald i estimeret GFR, som blev forbedret efter seponering af tenofovirdisoproxil.
English: In general, the pharmacokinetics of emtricitabine in infants, children and adolescents (aged 4 months up to 18 years) are similar to those seen in adults.
Danish: Generelt er emtricitabins farmakokinetik hos spædbørn, børn og unge (fra 4 måneder til 18 år) som hos voksne.
English: If bone abnormalities are suspected then appropriate consultation should be obtained.
Danish: Hvis der er mistanke om knogleabnormiteter, skal der søges råd i relevant omfang.
English: Emtricitabine/tenofovir disoproxil should only be used for pre-exposure prophylaxis as part of an overall HIV-1 infection prevention strategy including the use of other HIV-1 prevention measures (e.g. consistent and correct condom use, knowledge of HIV-1 status, regular testing for other sexually transmitted infections).
Danish: Emtricitabin/tenofovirdisoproxil bør kun bruges som profylakse før eksponering i forbindelse med en samlet strategi for forebyggelse af HIV 1-infektion, herunder brug af andre HIV 1-forebyggende foranstaltninger (f.eks. konsekvent og korrekt brug af kondom, viden om HIV 1-status, regelmæssig test for andre seksuelt overførte infektioner).
English: Mylan Hungary Kft Mylan utca 1, H-2900 Komárom, Hungary
Danish: Mylan Hungary Kft Mylan utca 1, H-2900 Komárom, Ungarn
English: In vitro protein binding of tenofovir to plasma or serum protein was less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 μg/mL.
Danish: Tenofovirs proteinbinding in vitro til plasma- eller serumproteiner var mindre end henholdsvis 0,7 og 7,2% i tenofovirkoncentrationsområdet på 0,01 til 25 µg/ml.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor may order blood tests to closely monitor your kidney function.
Danish: Hvis De tager et andet lægemiddel til behandling af HIV-infektion, som kaldes en proteasehæmmer, vil Deres læge muligvis bestille blodprøver for at overvåge nyrefunktionen nøje.
English: • swelling of the face, lips, tongue or throat
Danish: • hævelse i ansigt, læber, tunge eller svælg
English:  Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Danish:  Hvis De lægger mærke til nye eller usædvanlige symptomer efter behandlingens ophør, skal De omgående oplyse Deres læge herom, især hvis det drejer sig om symptomer, som De normalt ville forbinde med hepatitis B-infektion.
English: In infants and children older than 4 months, the majority of patients taking emtricitabine achieved or maintained complete suppression of plasma HIV 1 RNA through 48 weeks (89% achieved ≤ 400 copies/mL and 77% achieved ≤ 50 copies/mL).
Danish: Hos spædbørn og børn over 4 måneder opnåede eller bevarede størstedelen af de patienter, der fik emtricitabin, fuldstændig suppression af HIV 1-rna i plasma igennem 48 uger (89 % opnåede ≤ 400 kopier/ml, og 77 % opnåede ≤ 50 kopier/ml).
English: elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia abdominal pain, abdominal distension, flatulence
Danish: forhøjet amylase herunder forhøjet pancreasamylase, forhøjet serum-lipase, opkastning, abdominalsmerter, dyspepsi abdominalsmerter, abdominal distension, flatulens
English: increased creatinine, proteinuria, proximal renal tubulopathy including Fanconi syndrome
Danish: øget kreatinin, proteinuri, proksimal renal tubulopati, herunder Fanconis syndrom
English: The apparent clearance of tenofovir averaged approximately 307 mL/min.
Danish: Tenofovirs tilsyneladende clearance var i gennemsnit ca. 307 ml/min.
English: Studies with emtricitabine
Danish: Studier med emtricitabin
English: • If you are being treated for HIV infection your doctor will prescribe Emtricitabine/Tenofovir disoproxil Mylan with other antiretroviral medicines.
Danish: • Hvis De bliver behandlet for HIV-infektion, vil Deres læge ordinere Emtricitabine/Tenofovir disoproxil Mylan sammen med andre antiretrovirale lægemidler.
English: • other allergic reactions, such as wheezing, swelling or feeling light-headed
Danish: • andre allergiske reaktioner som pibende vejrtrækning, hævelser eller følelse af svimmelhed
English: • increased creatine kinase Common side effects
Danish: • forhøjet kreatinkinase Almindelige bivirkninger
English: • If you are an adult taking this medicine to reduce the risk of getting HIV, take this medicine every day, not just when you think you have been at risk of HIV infection.
Danish: • Hvis De er voksen og tager denne medicin for at nedsætte risikoen for at få HIV, skal De tage medicinen hver dag og ikke kun, når De mener, at De har været udsat for at blive smittet med HIV.
English: Limited data from clinical studies support once daily dosing in HIV-1 uninfected individuals with CrCl 60-80 mL/min.
Danish: Begrænsede data fra kliniske studier understøtter dosering én gang dagligt hos personer uden HIV 1-infektion med CrCl 6080 ml/min.
English: This medicine has been prescribed for you only.
Danish: Lægen har ordineret dette lægemiddel til Dem personligt.
English: • Know your hepatitis B virus (HBV) infection status before starting Emtricitabine/Tenofovir disoproxil Mylan.
Danish: • Kend Deres status for hepatitis B virus (HBV)-infektion, inden De begynder at tage Emtricitabine/Tenofovir disoproxil Mylan.
English: Missing doses may increase your risk of getting HIV infection.
Danish: Glemte doser kan øge Deres risiko for at få en HIV-infektion.
English: b Relative risk reduction calculated for mITT based on incident seroconversion, ie, occurring post-baseline through first posttreatment visit (approximately 1 month after last study drug dispensation).
Danish: b Relativ risikoreduktion beregnet for mITT baseret på hændelsesbaseret serokonvertering, dvs. som forekommer efter baseline til og med det første besøg efter behandlingen (ca. 1 måned efter sidste udlevering af forsøgsmedicin).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERPAKNING
English: In order to optimise the absorption of tenofovir, it is recommended that emtricitabine/tenofovir disoproxil should preferably be taken with food.
Danish: For at optimere tenofovirs absorption anbefales det, at emtricitabin/tenofovirdisoproxil helst tages sammen med mad.
English: Please refer to the Summary of Product Characteristics for these medicinal products.
Danish: Se produktresuméerne til disse lægemidler.
English: Risk of resistance with undetected HIV-1 infection:
Danish: Risiko for resistens med uopdaget HIV 1-infektion:
English: The primary efficacy endpoint for this study was the achievement and maintenance of confirmed HIV-1 RNA concentrations < 400 copies/mL over 48 weeks.
Danish: De primære virkningsendepunkter i dette studie var at opnå og vedligeholde bekræftede HIV 1-rna-koncentrationer < 400 kopier/ml i 48 uger.
English: Following intravenous administration, the volume of distribution of emtricitabine and tenofovir was approximately 1.4 L/kg and 800 mL/kg, respectively.
Danish: Efter intravenøs indgivelse blev emtricitabins og tenofovirs fordelingsvolumen vurderet til at være henholdsvis 1,4 l/kg og 800 ml/kg.
English: Combination of emtricitabine and tenofovir disoproxil: Genotoxicity and repeated dose toxicity studies of one month or less with the combination of these two components found no exacerbation of toxicological effects compared to studies with the separate components.
Danish: Kombination af emtricitabin og tenofovirdisoproxil: I studier af en måneds varighed eller derunder af genotoksicitet og af toksicitet efter gentagne doser med en kombination af disse to indholdsstoffer blev der ikke fundet nogen forværring af toksikologiske virkninger, sammenlignet med studier med de separate indholdsstoffer.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: Both emtricitabine triphosphate and tenofovir diphosphate are weak inhibitors of mammalian DNA polymerases and there was no evidence of toxicity to mitochondria in vitro and in vivo.
Danish: Både emtricitabintriphosphat og tenofovirdiphosphat er svage hæmmere af mammalian dnapolymeraser, og der var intet tegn på toksicitet over for mitokondrier in vitro eller in vivo.
English: Emtricitabine-resistant viruses with the M184V/I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir and zidovudine.
Danish: Emtricitabin-resistente virus med M184V/I-mutationen var krydsresistente over for lamivudin, men beholdt følsomhed over for didanosin, stavudin, tenofovir og zidovudin.
English: Efficacy was strongly correlated with adherence as assessed by detection of plasma or intracellular drug levels in a case-control study (Table 7).
Danish: Effekt var stærkt korreleret til adhærens, vurderet ud fra påvisning af plasma- eller intracellulære lægemiddelniveauer i et case-kontrol studie (Tabel 7).
English: If you accidentally take more than the recommended dose of Emtricitabine/Tenofovir disoproxil Mylan, contact your doctor or nearest emergency department for advice.
Danish: Hvis De ved et uheld tager mere end den anbefalede dosis Emtricitabine/Tenofovir disoproxil Mylan, skal De kontakte lægen eller den nærmeste skadestue for at få råd.
English: The safety profile of emtricitabine and tenofovir disoproxil in this study was consistent with the previous experience with these agents when each was administered with other antiretroviral agents.
Danish: Emtricitabins og tenofovirdisoproxils sikkerhedsprofiler i denne studie svarede til de tidligere erfaringer med disse komponenter, når disse var blevet administreret sammen med andre antiretrovirale stoffer.
English: Table 3: Tabulated summary of adverse reactions associated with the individual components of emtricitabine/tenofovir disoproxil based on clinical study and post-marketing experience
Danish: Tabel 3: Resumé af bivirkninger forbundet med de individuelle komponenter af emtricitabin/tenofovirdisoproxil baseret på erfaringer fra kliniske studier og efter markedsføring
English: Animal studies do not indicate harmful effects of emtricitabine or tenofovir disoproxil on fertility.
Danish: Dyreforsøg indikerer ingen skadelige virkninger af emtricitabin eller tenofovirdisoproxil på fertiliteten.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02
Danish: Emtricitabins binding in vitro til humane plasmaproteiner var < 4% og uafhængig af koncentrationsområdet på 0,02-200 µg/ml.
English: Adults with renal impairment:
Danish: Voksne med nedsat nyrefunktion:
English: Table 4: 48- and 144-week efficacy data from study GS-01-934 in which emtricitabine, tenofovir disoproxil and efavirenz were administered to antiretroviral-naïve patients with HIV-1 infection
Danish: Tabel 4: 48- og 144-ugers data vedrørende virkning fra studie GS-01-934, hvor emtricitabin, tenofovirdisoproxil og efavirenz blev administreret til antiretroviral-naive patienter med HIV 1infektion
English: HIV-1 infected patients receiving emtricitabine/tenofovir disoproxil or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Danish: HIV 1-inficerede patienter, som får emtricitabin/tenofovirdisoproxil eller anden antiretroviral behandling, kan fortsætte med at udvikle opportunistiske infektioner og andre komplikationer som følge af HIV-infektion og bør derfor forblive under nøje klinisk observation af læger, som har erfaring med behandling af patienter med HIV-associerede sygdomme.
English: The systemic clearance of emtricitabine averaged 307 mL/min.
Danish: Emtricitabins systemiske clearance var i gennemsnit 307 ml/min.
English: Administration of emtricitabine/tenofovir disoproxil with food resulted in a delay of approximately three quarters of an hour in reaching maximum tenofovir concentrations and increases in tenofovir AUC and Cmax of approximately 35% and 15%, respectively, when administered with a high fat or light meal, compared to administration in the fasted state.
Danish: Indgivelse af emtricitabin/tenofovirdisoproxil sammen med mad gav en forsinkelse på cirka tre kvarter i forhold til opnåelse af maksimale tenofovirkoncentration og en forøgelse i tenofovirs AUC og Cmax med henholdsvis ca. 35% og 15%, når det blev indgivet sammen med et let måltid eller et måltid med højt fedtindhold, sammenlignet med indgivelse i fastende tilstand.
English: In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.
Danish: Hos nogle patienter med fremskreden leversygdom eller cirrose bør behandlingen ikke ophøre, fordi det kan medføre forværring af Deres hepatitis, hvilket kan være livstruende.
English: Concomitant administration of sofosbuvir/velpatasvir and efavirenz is expected to decrease plasma concentrations of velpatasvir.
Danish: Samtidig administration af sofosbuvir/velpatasvir og efavirenz forventes at reducere plasmakoncentrationen af velpatasvir.
English: Proximal renal tubulopathy generally resolved or improved after tenofovir disoproxil discontinuation.
Danish: Proksimal renal tubulopati gik generelt væk eller blev bedre efter seponering af tenofovirdisoproxil.
English: 1 This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Danish: 1 Denne bivirkning kan forekomme som resultat af proksimal renal tubulopati.
English: However, tenofovir disoproxil reduced the viability index and weight of pups in a peri and postnatal toxicity study at maternally toxic doses.
Danish: Tenofovirdisoproxil reducerede imidlertid afkommets levedygtighed og vægt i et peri- og postnatalt toksicitetsstudie ved doser, der var toksiske for moderen.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Overførsel af HIV