FrancophonIA/ELRC3.0 huggingface dataset:
English: Other effects in children Children given emtricitabine very commonly experienced changes in skin colour including darkening of the skin in patches Children commonly experienced low red blood cell count (anaemia) - this may cause the child to be tired or breathless → If you notice any of these symptoms tell your doctor.
Danish: Andre bivirkninger hos børn Hos børn, der får emtricitabin, er det meget almindeligt at opleve ændringer i hudfarven, herunder - Pletvis mørkfarvning af huden Hos børn er det almindeligt at opleve et lavt antal røde blodlegemer (anæmi) - Dette kan forårsage, at barnet blivet træt eller stakåndet → Hvis De bemærker nogen af disse symptomer, skal De fortælle det til lægen.
English: Bone problems.
Danish: Problemer med knogler.
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures)
Danish: osteomalaci (manifesterer sig som knoglesmerter og i sjældne tilfælde medvirkende årsag til frakturer) myopati
English: During treatment for HIV there may be an increase in weight and in levels of blood lipids and glucose.
Danish: Under HIV-behandling kan der forekomme en stigning i legemsvægt og i et forhøjet indhold af lipider og glucose i blodet.
English: These infections make it easier for HIV to infect you.
Danish: Disse infektioner gøre Dem mere modtagelig for HIV.
English: HIV-1 infected patients receiving Emtricitabine/Tenofovir disoproxil Krka 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 Emtricitabine/Tenofovir disoproxil Krka 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: Individuals over the age of 65 years are more likely to have decreased renal function, therefore caution should be exercised when administering Emtricitabine/Tenofovir disoproxil Krka to older people.
Danish: Da det er mere sandsynligt, at personer over 65 år har nedsat nyrefunktion, skal der udvises forsigtighed ved administration af Emtricitabine/Tenofovir disoproxil Krka til ældre mennesker.
English: 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: 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: The effects of tenofovir disoproxilassociated changes in BMD on long-term bone health and future fracture risk are currently unknown (see section 5.1).
Danish: Indvirkningen af tenofovirdisoproxil-associerede ændringer i BMD på knoglesundheden på langt sigt og på den fremtidige frakturrisiko er ikke kendt for tiden (se pkt.
English: A small clinical study was conducted to evaluate the safety, antiviral activity and pharmacokinetics of tenofovir disoproxil in combination with emtricitabine in HIV infected patients with renal impairment.
Danish: En lille klinisk studie blev udført for at vurdere sikkerhed, antiviral aktivitet og farmakokinetik for tenofovirdisoproxil i kombination med emtricitabin hos hiv-inficerede patienter med nedsat nyrefunktion.
English: However, tenofovir disoproxil reduced the viability index and weight of pups in a periand 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: Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg and in 23 HIV1 infected children aged 2 to < 12 years.
Danish: Steady state farmakokinetik af tenofovir blev evalueret hos 8 hiv 1-inficerede unge patienter (i alderen 12 til < 18 år) med kropsvægt ≥ 35 kg og hos 23 hiv 1-inficerede børn i alderen 2 til < 12 år.
English: Emtricitabine/Tenofovir disoproxil Krka is also used to reduce the risk of getting HIV-1 infection in adults, and adolescents aged 12 years to less than 18 years who weigh at least 35 kg, when taken daily, together with safer sex practices:
Danish: Emtricitabine/Tenofovir disoproxil Krka bruges også til at nedsætte risikoen for at få HIV 1-infektion hos voksne og unge i alderen 12 år til under 18 år, som vejer mindst 35 kg, når det bruges dagligt og sammen med udøvelse af sikker sex:
English: In vitro and clinical pharmacokinetic interaction studies have shown the potential for CYP450 mediated interactions involving emtricitabine and tenofovir disoproxil with other medicinal products is low.
Danish: In vitro og kliniske farmakokinetiske interaktionsstudier har vist en lav risiko for CYP450-medierede interaktioner, hvor emtricitabin og tenofovirdisoproxil er involveret sammen med andre lægemidler.
English: If you accidentally take more than the recommended dose of Emtricitabine/Tenofovir disoproxil Krka, contact your doctor or nearest emergency department for advice.
Danish: Hvis De ved et uheld tager mere end den anbefalede dosis Emtricitabine/Tenofovir disoproxil Krka, skal De kontakte lægen eller den nærmeste skadestue for at få råd.
English: In vitro: Resistance has been seen in vitro and in some HIV-1 infected patients due to the development of the M184V/I mutation with emtricitabine or the K65R mutation with tenofovir.
Danish: In vitro: Der er observeret resistens in vitro og hos nogle hiv-1-inficerede patienter på grund af udvikling af M184V/I-mutationen med emtricitabin eller K65R-mutationen med tenofovir.
English: Tests may also show: decreases in phosphate in the blood increased creatine kinase
Danish: Prøver kan også vise: nedsat indhold af i phosphat i blodet forhøjet kreatinkinase
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Danish: Følgende pakningsstørrelser er tilgængelige: en æske der indeholder 1 tabletbeholder med 30 filmovertrukne tabletter og 90 (3 tabletbeholdere med 30) filmovertrukne tabletter.
English: Efficacy was strongly correlated with adherence as assessed by detection of plasma or intracellular drug levels and was higher among substudy participants who received active adherence counselling and as show in Table 10.
Danish: Virkning var stærkt korreleret med adhærens vurderet ud fra påvisning af plasma- eller intracellulære lægemiddelniveauer og var højere blandt deltagere i et substudie, der fik aktiv adhærensrådgivning som vist i Tabel 10.
English: Titanum dioxide (E171) Macrogol
Danish: Titandioxid (E171)
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in randomised controlled clinical studies (n = 1,563) or tenofovir disoproxil in randomised controlled clinical studies and the expanded access program (n = 7,319).
Danish: Frekvenskategorien blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter eksponeret for emtricitabin i randomiserede, kontrollerede kliniske studier (n = 1.563) eller tenofovirdisoproxil i randomiserede, kontrollerede, kliniske studier og i programmet for forlænget adgang (n = 7.319).
English: Pregelatinized starch Croscarmellose sodium Lactose monohydrate Microcrystalline cellulose Sodium stearyl fumarate Stearic acid
Danish: Stivelse, pregelatineret Croscarmellosenatrium Lactosemonohydrat Mikrokrystallinsk cellulose Natriumstearylfumarat Stearinsyre
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected subjects with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Danish: En enkelt dosis af 245 mg tenofovirdisoproxil blev administreret til ikke-hiv-inficerede forsøgspersoner med forskellige grader af nedsat leverfunktion defineret i henhold til Child-Pugh-Turcotte (CPT) klassifikationen.
English: Pack sizes: 28 and 84 film-coated tablets.
Danish: Pakningsstørelser: 28 og 84 filmovertrukne tabletter.
English: The adverse reactions considered at least possibly related to treatment with the tenofovir disoproxil and emtricitabine from clinical study and post-marketing experience in HIV-1 infected patients are listed in Table 3, below, by body system organ class and frequency.
Danish: De bivirkninger, som blev anset for i det mindste at have en mulig forbindelse til behandlingen med indholdsstofferne tenofovirdisoproxil og emtricitabin fra kliniske studier og erfaringer hos hiv 1inficerede patienter efter markedsføring er opført i Tabel 3, nedenfor, efter systemorganklasse og frekvens.
English: Some patients taking combination antiretroviral medicines such as emtricitabine/tenofovir disoproxil may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, der tager antiretroviral kombinationsmedicin såsom emtricitabin/tenofovirdisoproxil, kan udvikle en knoglesygdom, der hedder knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
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 1.
English: Secondary efficacy analyses over 144 weeks included the proportion of patients with HIV-1 RNA concentrations < 400 or < 50 copies/mL, and change from baseline in CD4 cell count.
Danish: Sekundære virkningsanalyser i løbet af de 144 uger omfattede andelen af patienter med hiv 1-rnakoncentrationer < 400 eller < 50 kopier/mL og en ændring i CD4-celletallet fra baseline.
English: In addition, the clinical response to treatment should be closely monitored in patients receiving Emtricitabine/Tenofovir disoproxil Krka at a prolonged dosing interval.
Danish: Det kliniske respons på behandlingen bør endvidere monitoreres nøje hos patienter, der får Emtricitabine/Tenofovir disoproxil Krka med et forlænget doseringsinterval.
English: Therefore, a careful benefitrisk assessment is needed when Emtricitabine/Tenofovir disoproxil Krka is used in patients with creatinine clearance < 60 mL/min, and renal function should be closely monitored.
Danish: Det er derfor nødvendigt nøje at vurdere fordele og risici, når Emtricitabine/Tenofovir disoproxil Krka anvendes til patienter med kreatininclearance < 60 ml/min, og nyrefunktionen bør monitoreres omhyggeligt.
English: This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Danish: Denne bivirkning kan forekomme som resultat af proksimal renal tubulopati.
English: Tenofovir disoproxil is indicated for the treatment of HBV and emtricitabine has shown activity against HBV in pharmacodynamic studies but the safety and efficacy of emtricitabine/tenofovir disoproxil have not been specifically established in patients with chronic HBV infection.
Danish: Tenofovir (disoproxil) er indiceret til behandling af HBV, og emtricitabin har udvist aktivitet over for HBV i farmakodynamiske studier, men emtricitabin/tenofovirdisoproxil sikkerhed og virkning er ikke blevet specifikt fastslået hos patienter med kronisk HBV-infektion.
English: Pack sizes: 30 film coated tablets (1x30) and 90 film-coated tablets (3x30).
Danish: Pakningsstørrelser: 30 filmovertrukne tabletter (1x30) og 90 filmovertrukne tabletter (3x30).
English: - Genotypic resistance to efavirenz, predominantly the K103N mutation, developed in virus from 13/19 (68%) patients in the emtricitabine/tenofovir disoproxil /efavirenz group and in virus from 21/29 (72%) patients in the comparative group.
Danish: - Genotyperesistens over for efavirenz, især K103N-mutationen, udviklede sig i virus fra 13/19 (68%) af patienterne i emtricitabin/tenofovirdisoproxil/efavirenz-gruppen og i virus fra 21/29 (72%) af patienterne i sammenligningsgruppen.
English: Emtricitabine/Tenofovir disoproxil Krka is available also in bottles of 30 tablets, with a child-resistant tamper evident plastic closure with integrated a silica gel desiccant, which helps to protect your tablets.
Danish: Emtricitabine/Tenofovir disoproxil Krka fås også i tabletbeholdere, der indeholder 30 tabletter med et børnesikret og forseglet låg af plastik med et integreret silicagel-tørremiddel, som hjælper med at beskytte Deres tabletter.
English: Tests may also show: low white blood cell count (a reduced white blood cell count can make you more prone to infection) increased triglycerides (fatty acids), bile or sugar in the blood liver and pancreas problems
Danish: Prøver kan også vise: lavt antal hvide blodlegemer (et fald i antallet af hvide blodlegemer kan gøre Dem mere modtagelig for infektion) forhøjet indhold af triglycerider (fedtsyrer), galde eller glucose (sukker) i blodet problemer med lever og bugspytkirtel
English: If you have hepatitis B, it is especially important not to stop your Emtricitabine/Tenofovir disoproxil Krka treatment 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 Krka uden først at konsultere Deres læge.
English: A multidisciplinary approach is recommended to weigh the benefit/risk balance of the use of emtricitabine/tenofovir for the treatment of HIV-1 infection or for pre-exposure prophylaxis, decide the appropriate monitoring during treatment (including decision for treatment withdrawal) and consider the need for supplementation on a case by case basis.
Danish: Multidisciplinær tilgang anbefales for at af afveje benefit/risk-forholdet ved brugen af emtricitabine/tenofovir til behandling af HIV 1-infektion eller profylakse før eksponering, for at kunne træffe afgørelse om relevant monitorering under behandlingen (herunder beslutning om seponering) og for at overveje behovet for supplerende behandling hos den enkelte patient.
English: Signs of osteonecrosis are: joint stiffness joint aches and pains (especially of the hip, knee and shoulder) difficulty with movement → If you notice any of these symptoms tell your doctor.
Danish: Tegn på knoglenekrose er: stivhed i led smerter i led (særligt i hofter, knæ og skuldre) svært ved at bevæge sig → Hvis De bemærker nogen af disse symptomer, skal De søge læge.
English: 28 film-coated tablets 84 film-coated tablets for bottle:
Danish: 28 filmovertrukne tabletter 84 filmovertrukne tabletter for tabletbeholderen:
English: Emtricitabine/tenofovir disoproxil is not always effective in preventing the acquisition of HIV-1.
Danish: Emtricitabine/tenofovirdisoproxil er ikke altid effektivt med hensyn til at forebygge smitte med HIV 1.
English: % difference (95%CI)
Danish: Forskel (95%CI)
English: The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 mL/min; mild impairment with CrCl = 50-79 mL/min; moderate impairment with CrCl = 30-49 mL/min and severe impairment with CrCl = 10-29 mL/min).
Danish: Graden af nedsat nyrefunktion blev defineret i henhold til kreatininclearance (CrCl) ved baselinie (normal nyrefunktion med CrCl > 80 ml/min; let nedsat nyrefunktion med CrCl = 50−79 ml/min; moderat nedsat nyrefunktion med CrCl = 30−49 ml/min og svært nedsat nyrefunktion medCrCl = 10−29 ml/min).
English: Ask your doctor if you have any questions about how to prevent getting HIV or prevent spreading HIV to other people.
Danish: Spørg Deres læge, hvis De vil vide mere om, hvordan De undgår at få hiv eller forhindrer spredning af hiv til andre mennesker.
English: Renal function (creatinine clearance and serum phosphate) should be evaluated prior to initiating emtricitabine/tenofovir for treatment of HIV-1 or for pre-exposure prophylaxis, and should be monitored during use as in adults (see above).
Danish: Nyrefunktionen (kreatininclearance og serumphosphat) skal evalueres før der startes på Emtricitabine/Tenofovir til behandling af HIV 1 eller til profylakse før eksponering, og den bør monitoreres under brugen på samme måde som hos voksne (se ovenfor).
English: - Do not share personal items that can have blood or body fluids on them, such as toothbrushes and razor blades.
Danish: Del ikke personlige ting, der kan være forurenet med blod eller kropsvæsker, såsom tandbørster og barberblade, med andre.
English: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage in HIV-1 infected patients when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Danish: Der har været rapporteret høj forekomst af virologisk svigt og fremkomst af resistens på et tidligt tidspunkt hos hiv 1-inficerede patienter, når tenofovirdisoproxil blev kombineret med lamivudin og abacavir eller med lamivudin og didanosin som regime én gang dagligt.
English: interleukin-2 (to treat cancer) cidofovir (for viral infection) non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Danish: foscarnet (mod virusinfektion) ganciclovir (mod virusinfektion) pentamidin (mod infektioner) vancomycin (mod bakterie-infektion) interleukin-2 (til behandling af kræft) cidofovir (mod virusinfektion) non-steroide antiinflammatoriske lægemidler (NSAID'er, til at lindre knogle- eller muskelsmerter)
English: Treatment of HIV-1 infection in the paediatric population There are no clinical studies conducted with emtricitabine/tenofovir disoproxil in the paediatric population with HIV-1 infection.
Danish: Behandling af HIV 1-infektion hos den pædiatriske population Der er ikke udført kliniske studier med emtricitabine/tenofovirdisoproxil hos den pædiatriske population med HIV 1-infektion.
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 60 80 ml/min, der ikke var inficeret med hiv 1, med CrCl 60 80 ml/min.
English: Renal and urinary disorders: Uncommon:
Danish: Nyrer og urinveje: Ikke almindelig:
English: BMD Z scores declined by -0.012 for lumbar spine and by -0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Danish: BMD Z-scorerne faldt med -0,012 i lænderygsøjlen og med -0,338 i hele kroppen hos de 64 forsøgspersoner, der fik tenofovirdisoproxil i 96 uger.
English: Emtricitabine/Tenofovir disoproxil Krka contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Emtricitabine/Tenofovir disoproxil Krka indeholder lactose Hvis De har fået at vide, at De ikke tåler andre sukkerarter, skal De tale med Deres læge, før De tager denne medicin.
English: Discontinuation of Emtricitabine/Tenofovir disoproxil Krka therapy in patients infected with HBV may be associated with severe acute exacerbations of hepatitis.
Danish: Seponering af Emtricitabine/Tenofovir disoproxil Krka hos patienter, der er inficeret med HBV, kan være forbundet med svær, akut forværring af hepatitis.
English: In general, emtricitabine pharmacokinetics in HBV infected subjects were similar to those in healthy subjects and in HIV infected patients.
Danish: Generelt lignede emtricitabins farmakokinetik hos HBV-inficerede patienter den hos raske forsøgspersoner og hos hiv-inficerede patienter.
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in HIV-1 infected patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Danish: Tilfælde af akut nyresvigt efter påbegyndelse af multiple ikke-steroide anti-inflammatoriske lægemidler (NSAID) eller NSAID i høj dosis er rapporteret hos hiv 1-inficerede patienter, som blev behandlet med tenofovirdisoproxil og havde risikofaktorer for nedsat nyrefunktion.
English: HIV-1 expressing three or more thymidine analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced susceptibility to tenofovir disoproxil.
Danish: Hiv 1, der eksprimerede 3 eller flere thymidin-analog-forbundne mutationer (TAMs), som omfattede enten M41L- eller L210Wrevers transkriptasemutation, udviste reduceret følsomhed over for tenofovirdisoproxil.
English: If clinical symptoms consistent with acute viral infection are present and recent (< 1 month) exposures to HIV-1 are suspected, use of Emtricitabine/Tenofovir disoproxil Krka should be delayed for at least one month and HIV-1 status reconfirmed before starting Emtricitabine/Tenofovir disoproxil Krka for pre-exposure prophylaxis.
Danish: Hvis der findes kliniske symptomer svarende til akut virusinfektion, og der er mistanke om nylige (< 1 måned) eksponeringer for HIV 1, bør brugen af Emtricitabine/Tenofovir disoproxil Krka udsættes mindst en måned og HIV 1-status bekræftes før påbegyndelse af Emtricitabine/Tenofovir disoproxil Krka som profylakse før eksponering.
English: Pharmacokinetic parameters were mainly determined following administration of single doses of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected subjects with varying degrees of renal impairment.
Danish: Farmakokinetiske parametre blev hovedsageligt bestemt efter administration af enkelte doser 200 mg emtricitabin eller 245 mg tenofovirdisoproxil til ikke-hiv-inficerede forsøgspersoner med forskellige grader af nedsat nyrefunktion.
English: Pre-exposure prophylaxis: No new adverse reactions to emtricitabine/tenofovir disoproxil were identified from two randomised placebo-controlled studies (iPrEx, Partners PrEP) in which 2,830 HIV-1 uninfected adults received emtricitabine/tenofovir disoproxil once daily for pre-exposure prophylaxis.
Danish: Profylakse før eksponering: Der blev ikke identificeret nogen nye bivirkninger fra emtricitabine/tenofovirdisoproxil i to randomiserede placebokontrollerede studier (iPrEx, Partners PrEP), hvor 2.830 voksne uden HIV 1-infektion fik emtricitabine/tenofovir disoproxil én gang dagligt som profylakse før eksponering.
English: In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected by tenofovir and results in low-level reduced susceptibility to abacavir, emtricitabine, lamivudine and tenofovir.
Danish: Desuden er en K70E-substitution i hiv 1-revers transkriptase blevet selekteret af tenofovir, hvilket fører til en nedsat følsomhed for abacavir, emtricitabin, lamivudin og tenofovir på lavt niveau.
English: Renal safety with emtricitabine/tenofovir disoproxil has only been studied to a very limited degree in HIV-1 infected patients with impaired renal function (creatinine clearance < 80 mL/min).
Danish: Emtricitabin/tenofovirdisoproxils renale sikkerhed er kun blevet undersøgt i meget begrænset omfang hos hiv 1-inficerede patienter med nedsat nyrefunktion (kreatininclearance < 80 ml/min).
English: Emtricitabine/tenofovir disoproxil has not been studied in HIV-1 uninfected individuals with creatinine clearance < 60 mL/min and is therefore not recommended for use in this population.
Danish: Emtricitabine/tenofovirdisoproxil er ikke blevet undersøgt hos personer uden HIV 1-infektion med kreatininclearance < 60 ml/min og anbefales derfor ikke til denne population.