FrancophonIA/ELRC3.0 huggingface dataset:
English:  If you notice these or any symptoms of inflammation or infection, get medical help immediately.
Danish:  Hvis De ser disse eller andre symptomer på inflammation eller infektion, skal De straks søge læge.
English: However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Danish: Som det kunne forventes, forekom stigninger i ASAT og ALAT dog hyppigere hos denne patientpopulation end i den generelle HIV-inficerede population.
English: Drug Not Detected
Danish: Lægemiddel Ikke Detekteret
English: • enlarged lymph nodes in the neck or groin  Tell your doctor about any flu-like illness - either in the month before starting this medicine, or at any time while taking this medicine.
Danish: • forstørrede lymfeknuder i halsen eller lysken  Fortæl Deres læge om al influenzalignende sygdom - enten i måneden, før De starter med denne medicin, eller når som helst, mens De tager denne medicin.
English: • It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at least 35 kg, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects.
Danish: • Det bruges også til at behandle HIV hos unge i alderen fra 12 til under 18 år, som vejer mindst 35 kg, og som allerede er blevet behandlet med andre HIV-lægemidler, som ikke længere er effektive, eller som har forårsaget bivirkninger.
English: Please refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.
Danish: Se indlægssedlerne for de andre antiretrovirale midler for vejledning i, hvordan disse lægemidler skal tages.
English: Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug; antivirale midler til behandling af HIV-infektioner, kombinationer.
English: Importance of adherence:
Danish: Betydning af adhærens:
English: Autoimmune disorders may occur many months after the start of treatment.
Danish: Autoimmune sygdomme kan forekomme mange måneder efter behandlingsstart.
English: 2 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Danish: 2 Anæmi var almindelig og misfarvning af huden (øget pigmentering) var meget almindelig, når emtricitabin blev indgivet til pædiatriske patienter.
English: • low white blood cell count (a reduced white blood cell count can make you more prone to infection)
Danish: • lavt antal hvide blodlegemer (et fald i antallet af hvide blodlegemer kan gøre Dem mere modtagelig for infektion)
English: Concomitant use not recommended
Danish: Samtidig brug anbefales ikke
English: 4.6 Fertility, pregnancy and lactation Pregnancy
Danish: 4.6 Fertilitet, graviditet og amning
English: • difficulty with movement  If you notice any of these symptoms tell your doctor.
Danish: • svært ved at bevæge sig  Hvis De bemærker nogen af disse symptomer, skal De søge læge.
English: Before and during treatment, your doctor may order blood tests to measure kidney function.
Danish: Før og under behandlingen kan Deres læge bestille blodprøver for at kontrollere nyrefunktionen.
English: Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.
Danish: Deres læge vil nøje tage stilling til om, det er nødvendigt at behandle Dem med kombinationer af tenofovir og didanosin.
English: 41 (4 to 79)
Danish: 41 (4 til 79)
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Danish: Selv om det er vist, at effektiv virussuppression med antiretroviral behandling reducerer risikoen for seksuel overførsel væsentligt, kan det ikke udelukkes, at der er en resterende risko.
English: See section 2 for a list of precautions to take against HIV infection.
Danish: Se punkt 2 for en liste over de forholdsregler, der skal tages, for ikke at få HIV-infektion.
English: Lactic acidosis occurs more often in women, particularly if they are overweight, and in people with liver disease.
Danish: Laktatacidose forekommer oftere hos kvinder, især hvis de er overvægtige, og hos personer med leversygdom.
English: GS-01-934 Treatment for 144 weeks
Danish: GS-01-934 Behandling i 144 uger
English: • vomiting or diarrhoea
Danish: • opkastning eller diarré
English: Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Danish: Op til 30% af emtricitabindosen og cirka 10% af tenofovirdosen kan fjernes ved hæmodialyse.
English: GS-01-934 Treatment for 48 weeks
Danish: GS-01-934 Behandling i 48 uger
English: • Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines to treat HIV infection.
Danish: • Autoimmune sygdomme (når immunsystemet angriber sunde væv i kroppen), kan også opstå, efter at De begynder at tage medicin for at behandle HIV-infektion.
English: Taking Emtricitabine/Tenofovir disoproxil Mylan with other medicines that can damage your kidneys: it is especially important to tell your doctor if you are taking any of these medicines, including
Danish: Indtagelse af Emtricitabine/Tenofovir disoproxil Mylan samtidig med andre lægemidler, som kan skade Deres nyrer: Det er specielt vigtigt at fortælle Deres læge, hvis De tager nogen af disse lægemidler, herunder
English: Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Danish: Studier af reproduktionstoksicitet udført hos rotter og kaniner viste ingen virkninger hverken på parrings-, fertilitets-, graviditets- eller fosterparametre.
English: • If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the virus to the baby in breast milk.
Danish: • Hvis De er en kvinde med HIV, anbefales det, at De ikke ammer for at undgå at overføre virus til barnet via mælken.
English: Methadone:
Danish: Methadon:
English: The incidences of HIV seroconversion overall and in the subset reporting unprotected receptive anal intercourse are shown in Table 6.
Danish: Forekomsten af HIV-serokonversion samlet set og i den delmængde, som rapporterede ubeskyttet receptivt analt samleje, er vist i Tabel 6.
English: Patients with hepatitis B or C virus infection
Danish: Patienter med hepatitis B- eller C-virusinfektion
English: Relative Risk Reduction (95% CI)b a P-values by logrank test. P-values for URAI refer to the null hypothesis that efficacy differed between subgroup strata (URAI, no URAI).
Danish: Serokonvertering / N Relativ Risikoreduktion (95% CI)b a P-værdier efter logrank test. P-værdien for URAI henviser til den nulhypotese, at effekten var forskellig mellem undergruppestrata (URAI, ingen URAI).
English: If you have taken Emtricitabine/Tenofovir disoproxil Mylan during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis De har taget Emtricitabine/Tenofovir disoproxil Mylan under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: In clinical studies of HIV-1 uninfected individuals, small decreases in BMD were observed.
Danish: I kliniske studier med personer uden HIV 1-infektion blev der observeret små fald i BMD.
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulphoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Danish: Emtricitabins biotransformation omfatter oxidation af thiolandelen til at danne 3'-sulfoxid-diastereomere (ca. 9% af dosen) og forbindelse med glucuronsyre til at danne 2'-O-glucuronid (ca. 4% af dosen).
English: Alternative treatment regimens should be considered for patients with osteoporosis that are at a high risk for fractures.
Danish: Andre behandlingsregimer bør overvejes til patienter med osteoporose, som har en høj risiko for knoglebrud.
English: Gender, N (%) Male
Danish: Køn, N (%)
English: Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%).
Danish: Emtricitabin udskilles primært gennem nyrerne med komplet genfinding af dosis opnået i urinen (ca. 86%) og fæces (ca. 14%).
English: • Provides information on the possible side effects
Danish: • Give oplysninger om bivirkninger
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: Difference (95%CI)
Danish: Forskel (95%CI)
English: If available, 90% confidence intervals are shown in parentheses.
Danish: 90% konfidensinterval er vist i parenteser, hvis det er muligt.
English: Eight of the 89 patients (9.0%) discontinued study drug due to renal adverse events.
Danish: Otte af de 89 patienter (9,0 %) seponerede studiemedicinen på grund af nyrebivirkninger.
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures)1,3, myopathy1
Danish: osteomalaci (manifesterer sig som knoglesmerter og i sjældne tilfælde medvirkende årsag til frakturer)1,3, myopati1
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES
English: • increased creatinine in your blood
Danish: • øget kreatinin i blodet
English: In individuals without risk factors for renal disease, it is recommended that renal function (creatinine clearance and serum phosphate) is monitored after two to four weeks of use, after three months of use and every three to six months thereafter.
Danish: Hos personer uden risikofaktorer for nyresygdom anbefales det, at nyrefunktionen (kreatininclearance og serumfosfat) monitoreres efter 2-4 ugers behandling, efter 3 måneder og derefter hver 3-6 måned.
English: elevated creatine kinase
Danish: forhøjet kreatinkinase
English: There is limited metabolism of emtricitabine.
Danish: Emtricitabins metabolisme er begrænset.
English: They may want to do more tests to make sure you are still HIV negative.
Danish: Lægen vil muligvis udføre flere test for at sikre, at De stadig er HIV-negativ.
English: 1 Data generated from simultaneous dosing with ledipasvir/sofosbuvir.
Danish: 1 Data genereret fra samtidig dosering af ledipasvir/sofosbuvir.
English: Comparisons for active study groups are made versus placebo.
Danish: Grupper med aktiv studiemedicin er sammenlignet med placebo.
English: The frequency of this is unknown (see section 4.4).
Danish: Hyppigheden er ukendt (se pkt.
English: • Adults: one tablet each day, where possible with food.
Danish: • Voksne: En tablet om dagen, så vidt muligt sammen med mad.
English: This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Danish: Dette skyldes dels forbedret sundhedstilstand og livsstil og med hensyn til lipider i blodet undertiden selve HIV-medicinen.
English: • Talk to your doctor if you are intolerant to lactose (see Emtricitabine/Tenofovir disoproxil Mylan contains lactose later in this section).
Danish: • Tal med Deres læge, hvis De ikke kan tåle lactose (se Emtricitabine/Tenofovir disoproxil Mylan indeholder lactose senere i dette afsnit).
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling for hepatitis B eller C henvises også til de relevante produktresuméer for disse lægemidler.
English: Discuss with your doctor the precautions needed to avoid infecting other people.
Danish: Tal med lægen om, hvilke forholdsregler der er nødvendige for at undgå at smitte andre personer.
English: In vitro studies have shown that both emtricitabine and tenofovir can be fully phosphorylated when combined together in cells.
Danish: Studier in vitro har vist, at både emtricitabin og tenofovir kan fosforyleres fuldstændigt, når de kombineres i celler.
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 hepatitis (gulsot).
English: For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Danish: Med hensyn til monitorering af blodlipider og blodglucose henvises til relevante retningslinjer for HIV-behandling.
English: Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Danish: Endvidere hæmmede emtricitabin ikke uridin-5'-diphosphoglucuronyl-transferase, det enzym, som er ansvarlig for glukuronidering.
English: In individuals at risk for renal disease more frequent monitoring of renal function is required.
Danish: Hos personer med risikofaktorer for nyresygdom skal nyrefunktionen monitoreres hyppigere.
English: Both emtricitabine and tenofovir have activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus.
Danish: Både emtricitabin og tenofovir har aktivitet, som er specifik mod human immundefekt virus (HIV 1 og HIV 2) og hepatitis B-virus.
English: Medis International a.s Bolatice, Prumyslova 961/16, 747 23 Bolatice, Czech Republic
Danish: Medis International a.s Bolatice, Prumyslova 961/16, 747 23 Bolatice, Tjekkiet
English: • joint aches and pains (especially of the hip, knee and shoulder)
Danish: • smerter i led (særligt i hofter, knæ og skuldre)
English: Titanium dioxide (E171) Triacetin
Danish: Titandioxid (E171)
English: Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products are listed in Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.” and once daily as “q.d.”).
Danish: Interaktioner mellem emtricitabin/tenofovirdisoproxil eller dets individuelle komponent(er) og andre lægemidler ses i Tabel 2 nedenfor (stigning er angivet som „↑“, fald som „↓“, ingen ændring som „↔“, to gange dagligt som „b.i.d.“, og en gang dagligt som „q.d.“).
English: renal failure (acute and chronic), acute tubular necrosis, nephritis (including acute interstitial nephritis)3, nephrogenic diabetes insipidus
Danish: nyresvigt (akut og kronisk), akut tubulær nekrose, nefritis (herunder akut interstitiel nefritis)3, nefrogen diabetes insipidus
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin with 90% confidence intervals if available (mechanism)
Danish: Virkning på lægemiddelkoncentrationer Gennemsnitlig ændring (%) i AUC, Cmax, Cmin med 90% konfidensintervaller hvis muligt (mekanisme)
English: Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (see section 4.4).
Danish: Eksempler herpå omfatter, men er ikke begrænsede til, aminoglykosider, amphotericin B, foscarnet, ganciclovir, pentamidin, vancomycin, cidofovir eller interleukin-2 (se pkt.
English: Reductions in BMD have been reported in paediatric patients.
Danish: Nedsat BMD er blevet rapporteret hos pædiatriske patienter.
English: Due to limitations of the study, a benefit of tenofovir disoproxil over placebo was not demonstrated based on plasma HIV 1 RNA levels at week 24.
Danish: På grund af begrænsninger i studiet blev der ikke påvist en fordel ved tenofovirdisoproxil i forhold til placebo på grundlag af plasmaniveauerne af HIV 1-rna i uge 24.
English:  If you notice any of the side effects listed above or if any of the side effects get serious, talk to your doctor or pharmacist.
Danish:  Hvis De bemærker nogen af de ovenfor anførte bivirkninger, eller hvis nogen af bivirkningerne bliver alvorlige, skal De tale med lægen eller apotekspersonalet.
English: • softening of the bones (with bone pain and sometimes resulting in fractures)
Danish: • blødgøring af knoglerne (med knoglesmerter og af og til med knoglebrud til følge)
English: These may be signs of HIV infection:
Danish: Følgende kan være tegn på HIV-infektion:
English: Limited data from clinical studies support once daily dosing (see section 4.4).
Danish: Begrænsede data fra kliniske studier understøtter dosering én gang dagligt (se pkt.
English: Renal clearance has been estimated to be approximately 210 mL/min, which is in excess of the glomerular filtration rate.
Danish: Renal clearance er beregnet til at være ca. 210 ml/min, hvilket er over den glomerulære filtrationshastighed.
English: • Reminder on the risk of development of HIV-1 drug resistance in undiagnosed HIV-1-Infected individuals
Danish: • Påmindelse om risikoen for at udvikle resistens over for HIV 1-medicin hos ikke diagnosticerede HIV 1-inficerede personer
English: EXP: <for carton only>
Danish: UDLØBSDATO EXP: <kun til æske>
English: • increased triglycerides (fatty acids), bile or sugar in the blood
Danish: • forhøjet indhold af triglycerider (fedtsyrer), galde eller glucose (sukker) i blodet
English: The HIV paediatric renal educational brochure should contain the following key messages:
Danish: Undervisningsbrochuren om HIV og nyrefunktion hos pædiatriske patienter skal indeholde følgende hovedbudskaber:
English: elevated serum aspartate aminotransferase (AST) and/or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia increased transaminases
Danish: forhøjet serum-aspartataminotransferase (ASAT) og/eller forhøjet serum-alaninaminotransferase (ALAT), hyperbilirubinæmi forhøjede aminotransferaser
English: Emtricitabine is a nucleoside analogue of cytidine.
Danish: Emtricitabin er en nukleosidanalog af cytidin.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: It is not considered to be causally associated with tenofovir disoproxil in the absence of this condition.
Danish: Den anses ikke som årsagsmæssigt forbundet med tenofovirdisoproxil, hvis denne tilstand ikke er til stede.
English: Additive to synergistic effects were observed in combination studies with protease inhibitors, and with nucleoside and non-nucleoside analogue inhibitors of HIV reverse transcriptase.
Danish: Additive til synergistiske virkninger observeredes i kombinationsstudier med proteasehæmmere og med nukleosid- og non-nukleosid-analoghæmmere af HIV-revers transkriptase.
English: • Bone problems.
Danish: • Problemer med knogler.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: • Emtricitabine/Tenofovir disoproxil Mylan 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 used as a daily treatment, together with safer sex practices:
Danish: • Emtricitabine/Tenofovir disoproxil Mylan 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 som daglig behandling og sammen med udøvelse af sikker sex:
English: • Children given emtricitabine very commonly experienced changes in skin colour including: - darkening of the skin in patches.
Danish: • Hos børn, der får emtricitabin, er det meget almindeligt at opleve ændringer i hudfarven, herunder - Pletvis mørkfarvning af huden
English: Maximum emtricitabine and tenofovir concentrations are observed in serum within 0.5 to 3.0 h of dosing in the fasted state.
Danish: Maksimale koncentrationer af emtricitabin og tenofovir ses i serum inden for 0,5 til 3,0 timer efter indgivelse i fastende tilstand.
English: Table 1: Dosing recommendations in adults with renal impairment
Danish: Tabel 1: Doseringsanbefalinger hos voksne med nedsat nyrefunktion
English: a Relative risk reduction calculated for mITT cohort based on incident (post-baseline) seroconversion.
Danish: a Relativ risikoreduktion beregnet for mITT-kohorte baseret på hændelsen (post-baseline) serokonvertering.
English: Physicians should refer to current HIV treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).
Danish: Læger skal henholde sig til gældende retningslinjer for HIV-behandling ved håndtering af HIV-infektion hos patienter med samtidig infektion med hepatitis B-virus (HBV) eller hepatitis C-virus (HCV).
English: McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
Danish: McDermott Laboratories Limited T/A Gerard Laboratories T/A Dublin Mylan 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Irland
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced (BMD) (rats and dogs).
Danish: Knogletoksicitet blev diagnosticeret som osteomalaci (aber) og nedsat knoglemineraltæthed (BMD) (rotter og hunde).
English: Decreases in BMD of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil treatment group at 144 weeks.
Danish: Fald i BMD i rygsøjlen og ændringer i knoglebiomarkører i forhold til baseline var signifikant større i gruppen med tenofovirdisoproxil efter 144 uger.
English: Involved in Transactional Sex Last 6 Month, N (%) Known HIV+ Partner Last 6 Months, N (%) Syphilis Seroreactivity, N (%)
Danish: 6 måneder, N (%) Kendt HIV+ partner sidste 6 måneder, N (%) Syfilis seroreaktivitet, N (%)
English: The most frequent adverse reaction reported in the emtricitabine/tenofovir disoproxil group in the iPrEx study was headache (1%).
Danish: Den hyppigste bivirkning i emtricitabin/tenofovirdisoproxil-gruppen i iPrEx-studiet var hovedpine (1%).
English: • If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of therapy with emtricitabine/Tenofovir disoproxil 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 behandling med emtricitabin/tenofovirdisoproxil indebærer for Dem og Deres barn.
English: Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Danish: Tenofovir udskilles primært af nyrerne både ved filtration og et aktivt tubulært transportsystem, hvor ca. 70-80% af dosen udskilles uomdannet i urinen efter intravenøs indgivelse.
English: There is close structural similarity between lamivudine and emtricitabine and similarities in the pharmacokinetics and pharmacodynamics of these two agents.
Danish: Der er en tæt strukturel lighed mellem lamivudin og emtricitabin og lighed i farmakokinetikken og farmakodynamikken mellem disse to stoffer.