FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of your antiretroviral therapy to you and your child.
Danish: • Hvis De bliver gravid eller planlægger at blive gravid, skal De kontakte Deres læge for at drøfte de potentielle fordele og risici, som den antiretrovirale behandling indebærer for Dem og Deres barn.
English: • If you are allergic to emtricitabine or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis De er allergisk over for emtricitabin eller et af de øvrige indholdsstoffer i Emtriva (angivet i punkt 6).
English: Stopping treatment with Emtriva may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Danish: At ophøre med behandlingen med Emtriva kan resultere i nedsat virkning af den kur mod hiv, som Deres læge har anbefalet.
English: If you are unsure how much Emtriva you should take ask your doctor or pharmacist.
Danish: Hvis De ikke er sikker på, hvor meget Emtriva De skal give, skal De spørge Deres læge eller apotek.
English: tell your doctor at once.
Danish: skal De omgående fortælle Deres læge det.
English: • muscle pain and weakness (if creatine kinase levels in the blood are increased)
Danish: • muskelsmerter og -svaghed (hvis kreatinkinaseindholdet i blodet er forøget)
English: After opening: Do not store above 25°C.
Danish: Efter åbning: Må ikke opbevares ved temperaturer over 25 °C.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/mL.
Danish: In vitro binding af emtricitabin til humane plasmaproteiner var < 4% og uafhængig af koncentrationen over området på 0,02-200 µg/ml.
English: • low white blood cell count (a reduced white blood cell count can make you more prone to infection)
Danish: • lavt antal af hvide blodlegemer (et fald i antallet af hvide blodlegemer kan gøre Dem mere modtagelig for infektion)
English: Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Danish: Relevante eksempler omfatter cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og pneumocystis jirovecii pneumoni.
English: Keep the oral solution bottle with you so that you can easily describe what you have taken.
Danish: Tag flasken med den orale opløsning med, så De let kan vise, hvad De har taget.
English: If you have difficulty in swallowing the capsules, tell your doctor.
Danish: Hvis De har problemer med at synke kapslerne, skal De sige det til Deres læge.
English: Resistance: HIV-1 resistance to emtricitabine develops as the result of changes at codon 184 causing the methionine to be changed to a valine (an isoleucine intermediate has also been observed) of the HIV reverse transcriptase.
Danish: Resistens: hiv 1 resistens over for emtricitabin udvikles som følge af ændringer ved codon 184, som bevirker, at methioninen omdannes til en valin (en intermediær isoleucin er også blevet observeret) af hiv-reverse transkriptase.
English: Intracellular pharmacokinetics: In a clinical study, the intracellular half-life of emtricitabine-triphosphate in PBMCs was 39 hours.
Danish: Intracellulær farmakokinetik: I en klinisk studier var emtricitabin-triphosphats intracellulære halveringstid i PMBC'er 39 timer.
English: • Talk to your doctor if you have a history of liver disease, including hepatitis.
Danish: • Tal med Deres læge, hvis De tidligere har haft en leversygdom, herunder gulsot (hepatitis).
English: Therefore Emtriva should not be used during breastfeeding.
Danish: Emtriva bør derfor ikke anvendes under amning.
English: If there is any solution left in the bottle after 45 days, this should be disposed of in accordance with local requirements or returned to the pharmacy.
Danish: Hvis der stadig er en del af opløsningen tilbage i flasken efter 45 dage bør den destrueres i henhold til lokale retningslinjer eller leveres tilbage til apoteket.
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Emtriva.
Danish: Nogle patienter har fået taget blodprøver eller har symptomer, som viser, at deres hepatitis er forværret efter ophør med behandlingen med Emtriva.
English: Emtriva is also available as hard capsules.
Danish: Emtriva kan også fås som hårde kapsler.
English: Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Danish: Efter oral administration er eliminationshalveringstiden af emtricitabin ca. 10 timer.
English: Pharmacotherapeutic group: Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF09
Danish: Farmakoterapeutisk klassifikation: Nukleosid og nukleotid reverse transkriptasehæmmere, ATC-kode: J05AF09
English: Steady-state trough plasma concentrations reached levels approximately 4-fold above the in vitro IC90 values for anti-HIV activity.
Danish: De minimale steady-state plasmakoncentrationer nåede niveauer, som var ca. 4 gange så høje som in vitro IC90 værdierne for anti-hiv-aktivitet.
English: The systemic clearance of emtricitabine averaged 307 mL/min (4.03 mL/min/kg).
Danish: Emtricitabins systemiske clearance var i gennemsnit 307 ml/min (4,03 ml/min/kg).
English: When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient.
Danish: Ved beslutning om et nyt regime til patienter, som ikke har haft virkning af et antiretroviralt regime, skal mutationsmønstrene i forbindelse med forskellige lægemidler samt den enkelte patients behandlingsanamnese overvejes omhyggeligt.
English: Osteonecrosis: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Danish: Osteonekrose: Tilfælde af osteonekrose er rapporteret, specielt hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig CART.
English: Based on the results of these in vitro experiments and the known elimination pathways of emtricitabine, the potential for CYP450 mediated interactions involving emtricitabine with other medicinal products is low.
Danish: Baseret på resultaterne af disse in vitro forsøg og emtricitabins kendte eliminationsveje er risikoen for CYP450-medierede interaktioner mellem emtricitabin og andre lægemidler lav.
English: Patients co-infected with HBV
Danish: Patienter, som samtidig er inficerede med HBV
English: However, patients should be informed that dizziness has been reported during treatment with emtricitabine.
Danish: Patienter bør dog underrettes om, at svimmelhed er blevet indberettet som en bivirkning under behandling med emtricitabin.
English: 170 mL oral solution.
Danish: 170 ml oral opløsning.
English: Emtricitabine has been shown to be excreted in human milk.
Danish: Emtricitabin udskilles i human mælk.
English: In antiretroviral treatment-naïve adults, emtricitabine was significantly superior to stavudine when both medicinal products were taken in combination with didanosine and efavirenz through 48 weeks of treatment.
Danish: Hos antiretroviral-behandlingsnaive voksne var emtricitabin signifikant bedre end stavudin, når begge lægemidler blev taget i kombination med didanosin og efavirenz gennem 48 ugers behandling.
English: There are no data regarding the efficacy and only very limited data regarding the safety of emtricitabine in infants below 4 months of age.
Danish: Der foreligger ingen data med hensyn til virkningen og kun meget begrænsede data vedrørende sikkerheden af emtricitabin hos børn under 4 måneder.
English: In case of concomitant antiviral therapy for hepatitis B or C, please also refer to the relevant Summary of Product Characteristics for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling af hepatitis B eller C, henvises der også til de relevante produktresuméer til disse lægemidler.
English: Warnings and precautions • Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys.
Danish: Advarsler og forsigtighedsregler • Fortæl Deres læge det, hvis De tidligere har haft nyresygdomme, eller hvis undersøgelser har vist, at De har nyreproblemer.
English: diarrhoea, nausea
Danish: diarré, kvalme
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 flasken og kartonen efter „EXP“.
English: Therefore Emtriva is not recommended for use in those aged less than 4 months (for pharmacokinetic data in this age group, see section 5.2).
Danish: Derfor bør Emtriva ikke anvendes hos børn under 4 måneder (angående farmakokinetiske data for denne aldersgruppe, se pkt.
English: The apparent volume of distribution after intravenous administration of emtricitabine was 1.4 ± 0.3 L/kg, indicating that emtricitabine is widely distributed throughout the body to both intracellular and extracellular fluid spaces.
Danish: Det tilsyneladende fordelingsvolumen efter intravenøs administration af emtricitabin var 1,4 ± 0,3 l/kg, hvilket indikerer, at emtricitabin fordeles i stort omfang i hele legemet til både intracellulære og ekstracellulære væskerum.
English: If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
Danish: Hvis De har en hepatitis B-infektion, vil Deres læge nøje overveje, hvilken behandling, der er den bedste for Dem.
English: The clear solution is orange to dark orange in colour.
Danish: Den klare opløsning har en orange til mørkorange farve.
English: It is not known whether emtricitabine can be removed by peritoneal dialysis.
Danish: Det vides ikke, om emtricitabin kan fjernes ved peritonealdialyse.
English: This medicine is not a cure for HIV infection.
Danish: Denne form for medicin helbreder ikke hiv-infektionen.
English: If you have advanced HIV disease (AIDS) and another infection, you may develop inflammation or worsening of the symptoms of infection when you start treatment with Emtriva.
Danish: Hvis De har en fremskreden hiv-sygdom (aids) og en anden infektion, kan De udvikle en betændelse eller opleve en forværring af symptomerne på infektionen, når De begynder på behandlingen med Emtriva.
English: Consequently, the use of emtricitabine in combination with lamivudine for the treatment of HIV infection cannot be recommended at this time.
Danish: Derfor kan anvendelsen af emtricitabin i kombination med lamivudin til behandlingen af hiv-infektion ikke anbefales på nuværende tidspunkt.
English: No human data on the effect of emtricitabine are available.
Danish: Der foreligger ingen humane data vedrørende virkningen af emtricitabin.
English: There was no evidence of toxicity to mitochondria in vitro or in vivo.
Danish: Der var ingen tegn på toksicitet over for mitokondrier in vitro eller in vivo.
English: Emtriva should always be combined with other medicines to treat HIV infection.
Danish: Emtriva bør altid kombineres med anden medicin til at behandle hiv-infektion.
English: These are only suitable for patients who weigh at least 33 kg and can swallow hard capsules.
Danish: Disse er kun egnede til patienter, som vejer mindst 33 kg og kan synke hårde kapsler.
English: Patients should be instructed that any solution left in the bottle 45 days after opening should be disposed of in accordance with local requirements or returned to the pharmacy.
Danish: Patienter skal oplyses om, at al opløsning, der er tilbage i flasken 45 dage efter åbningen, bør destrueres i henhold til lokale retningslinjer eller leveres tilbage til apoteket.
English: • being sick (vomiting), problems with digestion resulting in discomfort after meals, stomach pain
Danish: • opkastning, problemer med fordøjelsen, som resulterer i ubehag efter måltider, mavesmerter
English: Animal studies do not indicate harmful effects of emtricitabine on fertility.
Danish: Dyreforsøg indikerer ingen skadelige virkninger af emtricitabin på fertiliteten.
English: Skin discolouration (increased pigmentation): Skin discolouration, manifested by hyperpigmentation mainly on the palms and/or soles, was generally mild, asymptomatic and of little clinical significance.
Danish: Misfarvning af huden (forøget pigmentering): Misfarvning af huden, der manifesterede sig ved øget pigmentdannelse, hovedsageligt på håndflader og/eller fodsåler, var generelt let, asymptomatisk og af ringe klinisk betydning.
English: 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: 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: Emtriva should not be taken with any other medicinal products containing emtricitabine or medicinal products containing lamivudine.
Danish: Emtriva bør ikke tages sammen med andre lægemidler, der indeholder emtricitabin, eller lægemidler, der indeholder lamivudin.
English: Patients receiving emtricitabine 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: Patienter, som får emtricitabin eller en anden antiretroviral behandling kan fortsætte med at udvikle opportunistiske infektioner og andre komplikationer af hiv-infektionen og bør derfor holdes under nøje klinisk observation af læger, som har erfaring i behandlingen af patienter med hiv-associerede sygdomme.
English: The mean plasma to blood concentration ratio was approximately 1.0 and the mean semen to plasma concentration ratio was approximately 4.0.
Danish: Det gennemsnitlige plasma- til blodkoncentrationsforhold var ca. 1,0, og det gennemsnitlige sperma- til plasmakoncentrationsforhold var ca. 4,0.
English: After opening the bottle, do not store above 25°C.
Danish: Efter at flasken er åbnet, må opløsningen ikke opbevares ved temperaturer over 25 °C.
English: Contact your doctor again before you restart taking Emtriva capsules.
Danish: Kontakt Deres læge, før De igen begynder at tage Emtriva kapslerne.
English: Emtriva contains the active substance emtricitabine.
Danish: Emtriva indeholder det aktive stof emtricitabin.
English: If you notice signs of inflammation or infection soon after you start taking Emtriva,
Danish: Hvis De bemærker tegn på betændelse eller infektion i den første tid efter, De har påbegyndt behandlingen med Emtriva,
English: Age Pharmacokinetic data are not available in the elderly (over 65 years of age).
Danish: Alder Der foreligger ikke farmakokinetiske data vedrørende ældre (over 65 år).
English: This active substance is an antiretroviral medicine which is used to treat HIV infection.
Danish: Dette aktive stof er en form for antiretroviral medicin, som anvendes til behandling af hiv-infektion.
English: There is no clinical experience of the use of emtricitabine in infants less than 4 months of age.
Danish: Der er ingen klinisk erfaring med anvendelsen af emtricitabin hos børn under 4 måneder.
English: Mitochondrial dysfunction following exposure in utero Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Danish: Mitokondriel dysfunktion efter eksponering in utero Nukleos(t)idanaloger kan påvirke mitokondriefunktionen i variende grad, hvilket er mest udpræget med stavudin, didanosin og zidovudin.
English: Emtriva oral solution is particularly suitable for people who have difficulty in swallowing Emtriva hard capsules.
Danish: Emtriva oral opløsning er specielt egnet til patienter, som har problemer med at synke Emtriva hårde kapsler.
English: These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings.
Danish: Disse fund bør overvejes for alle børn, der har været eksponeret for nukleos(t)idanaloger in utero, som har svære kliniske resultater af ukendt ætiologi, især neurologiske resultater.
English: Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ.
Danish: Emtricitabin er en svag hæmmer af mammalian dna-polymerase α, β og ε og mitokondriel dna-polymerase γ.
English: There is insufficient evidence to determine whether re-initiation of emtricitabine alters the course of post-treatment exacerbations of hepatitis.
Danish: Der er ikke tilstrækkelig dokumentation til at fastlægge, om en genoptagelse af emtricitabin ændrer udviklingen af eksacerbationer af hepatitis, der er fremkommet efter emtricitabinbehandlingens ophør.
English: Patients with end-stage renal disease (ESRD) managed with other forms of dialysis such as ambulatory peritoneal dialysis have not been studied and no dose recommendations can be made.
Danish: Patienter med nyresygdom i slutstadiet (End Stage Renal Disease, ESRD), der behandles med andre former for dialyse som f.eks. ambulant peritonealdialyse, er ikke blevet undersøgt, og dosisanbefalinger kan ikke gives.
English: Elderly: There are no safety and efficacy data available in patients over the age of 65 years.
Danish: Ældre: Der foreligger ingen data vedrørende sikkerhed og virkning hos patienter over 65 år.
English: Please also refer to the Summaries of Product Characteristics of the other antiretroviral medicinal products used in the combination regimen.
Danish: Se også produktresuméerne til de andre antiretrovirale lægemidler, som anvendes i det kombinerede regime.
English: Intracellular triphosphate levels increased with dose, but reached a plateau at doses of 200 mg or greater.
Danish: Intracellulære triphosphatniveauer steg med dosen, men nåede et fast, højt niveau ved doser på 200 mg eller derover.
English: Emtricitabine did not exhibit cytotoxicity to peripheral blood mononuclear cells (PBMCs), established lymphocyte and monocyte-macrophage cell lines or bone marrow progenitor cells in vitro.
Danish: Emtricitabin udviste ikke cytotoksicitet over for mononukleære celler i perifert blod (PBMC'er), etablerede lymfocyt- og monocyt-makrofagcellelinier eller knoglemarvsstamceller in vitro.
English: Contact your doctor again before you restart taking Emtriva oral solution.
Danish: Kontakt Deres læge, før De igen begynder at tage Emtriva oral opløsning.
English: The absolute bioavailability of emtricitabine from Emtriva 200 mg hard capsules was estimated to be 93% and the absolute bioavailability from Emtriva 10 mg/mL oral solution was estimated to be 75%.
Danish: Den absolutte biotilgængelighed af emtricitabin fra Emtriva 200 mg hårde kapsler blev vurderet til at være 93%, og den absolutte biotilgængelighed fra Emtriva 10 mg/ml oral opløsning blev vurderet til at være 75%.
English: Contains E110, E216, E218, sodium and propylene glycol, see leaflet for further information.
Danish: Indeholder E110, E216, E218, natrium og propylenglycol, se indlægssedlen for at få yderligere information.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Danish: Patienter med tidligere forekommende leverdysfunktion herunder kronisk aktiv hepatitis har en øget frekvens af leverfunktionsabnormiteter under antiretroviral kombinationsbehandling (CART) og bør monitoreres i henhold til normal praksis.
English: Each blister pack contains 30 hard capsules.
Danish: Hver blisterpakning indeholder 30 hårde kapsler.
English: Capsule contents Crospovidone
Danish: Kapslen indeholder Crospovidon
English: Patients co-infected with HIV and HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with emtricitabine for evidence of exacerbations of hepatitis.
Danish: Patienter, som samtidig er inficerede med hiv og HBV, bør monitoreres tæt med både klinisk og laboratorisk opfølgning i mindst flere måneder, efter behandlingen med emtricitabin ophører, for tegn på eksacerbationer af hepatitis.
English: • dizziness, weakness, difficulty sleeping, abnormal dreams
Danish: • svimmelhed, svaghedsfølelse, søvnløshed, unormale drømme
English: 3 This adverse reaction, which was identified through post-marketing surveillance, was not observed in randomised controlled clinical trials in adults or paediatric HIV clinical trials of emtricitabine.
Danish: 3 Denne bivirkning, som blev identificeret under sikkerhedsovervågningen efter markedsføring, blev ikke observeret i randomiserede, kontrollerede, kliniske studier af emtricitabin hos voksne eller pædiatriske patienter med hiv.
English: If you are older than this and are prescribed Emtriva, your doctor will monitor you carefully.
Danish: Hvis De er over 65 år og får ordineret Emtriva, vil Deres læge overvåge Dem nøje.
English: The pack also contains a 30 mL polypropylene measuring cup with 1.0 mL graduations.
Danish: Pakningen indeholder også et 30 ml målebæger af polypropylen med 1,0 ml gradinddelinger.
English: Up to 30% of the emtricitabine dose can be removed by haemodialysis.
Danish: Op til 30% af emtricitabindosen kan fjernes ved hæmodialyse.
English: If it is almost time (less than 12 hours) for your next dose anyway, forget about the missed dose.
Danish: Hvis det næsten er tid til (der er mindre end 12 timer til) næste dosis, skal De ikke tage den glemte dosis.
English: The use of emtricitabine in patients with chronic HBV induces the same mutation pattern in the YMDD motif observed with lamivudine therapy.
Danish: Brug af emtricitabin hos patienter med kronisk HBV-infektion forårsager det samme mutationsmønster i YMDD-motivet, som ses ved behandling med lamivudin.
English: Additionally, in a second study, treatment-experienced adults on a stable PI-based highly active antiretroviral therapy (HAART) regimen were randomised to a once daily regimen containing emtricitabine or to continue with their PI-HAART regimen.
Danish: Endvidere i et andet forsøg blev behandlingserfarne voksne på et stabilt PI-baseret, højt aktivt, antiretroviralt behandlingsregime (HAART) randomiseret til et regime med én daglig dosis af emtricitabin eller til at fortsætte med deres PI-HAART regime.
English: A moderate amount of data on pregnant women (between 300 and1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine.
Danish: Data fra anvendelse af emtricitabin hos et begrænset antal gravide kvinder (mellem 300 og 1.000) indikerer ingen misdannelser eller føtal/neonatal toksicitet i forbindelse med emtricitabin.
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Danish: For lipider er der i visse tilfælde fundet evidens for en behandlingsvirkning, mens der ikke er tydelig evidens for relation mellem vægtstigning og en specifik behandling.
English: In clinical trials of HIV infected adults, the most frequently occurring adverse reactions to emtricitabine were diarrhoea (14.0%), headache (10.2%), elevated creatine kinase (10.2%) and nausea (10.0%).
Danish: I kliniske studier med hiv-inficerede voksne var de hyppigst forekommende bivirkninger af emtricitabin diarré (14,0%,) hovedpine (10,2%), forhøjet kreatinkinase (10,2%) og kvalme (10,0%).
English: Children given emtricitabine also experienced changes in skin colour including darkening of the skin in patches, very commonly and anaemia (low red blood cell count), commonly.
Danish: Hos børn, som fik emtricitabin, optrådte der desuden ændringer i hudfarven, herunder pletvis mørkfarvning af huden, meget almindeligt og anæmi (lavt antal af røde blodlegemer) almindeligt.