FrancophonIA/ELRC3.0 huggingface dataset:
English: Interactions between Emtricitabine/Tenofovir disoproxil Zentiva 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 Emtricitabine/Tenofovir disoproxil Zentiva 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: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV
Danish: 3 Studiet blev gennemført med yderligere voxilaprecir 100 mg for at opnå de forventede voxilaprevir eksponeringer hos HCV-inficerede patienter.
English: Risk Estimate for HIV-1 Protection: Detection Versus No Detection of Tenofovir
Danish: Risikoestimat for HIV 1-beskyttelse Detektering af vs. ingen detektering af tenofovir
English: If you notice any of these symptoms tell your doctor.
Danish: Hvis du bemærker nogen af disse symptomer, skal du fortælle det til lægen.
English: Psychiatric disorders Common insomnia, abnormal dreams
Danish: Psykiske forstyrrelser Almindelig insomnia, unormale drømme
English: b Relative risk reduction calculated for mITT based on incident seroconversion, ie, occurring post-baseline through first post-treatment 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: Key Couple Characteristics, N (%) or Median (Q1, Q3) Married to study partner
Danish: Vigtigste parkarakteristika, N (%) eller Median (1. kvartil, 3. kvartil) Gift med studiepartner
English: • increased triglycerides (fatty acids), bile or sugar in the blood,
Danish: • forhøjet indhold af triglycerider (fedtsyrer), galde eller glucose (sukker) i blodet
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 administration blev emtricitabins og tenofovirs fordelingsvolumen vurderet til at være henholdsvis 1,4 l/kg og 800 ml/kg.
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 administration.
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: Table 2: Interactions between Emtricitabine/Tenofovir disoproxil Zentiva or its individual component(s) and other medicinal products
Danish: Tabel 2: Interaktion mellem Emtricitabine/Tenofovir disoproxil Zentiva eller dets individuelle komponent(er) og andre lægemidler
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 du bemærker nogen af de ovenfor anførte bivirkninger, eller hvis nogen af bivirkningerne bliver alvorlige, skal du tale med lægen eller apotekspersonalet.
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: • Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).
Danish: • Knogleproblemer (giver somme tider anledning til brud) kan også forekomme på grund af skader på tubulære celler i nyrerne (se punkt 4, Bivirkninger).
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 nukleosidog non-nukleosid-analoghæmmere af HIV-revers transkriptase.
English: Missing doses may increase your risk of getting HIV infection.
Danish: Glemte doser kan øge din risiko for at få en HIV-infektion.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 μg/ml.
Danish: Emtricitabins binding in vitro til humane plasmaproteiner var < 4% og uafhængig af koncentrationsområdet på 0,02 til 200 µg/ml.
English: • difficulty sleeping, abnormal dreams,
Danish: • søvnløshed, unormale drømme
English: Rare 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: Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Danish: Hvis du lægger mærke til nye eller usædvanlige symptomer efter behandlingens ophør, skal du omgående oplyse din læge herom, især hvis det drejer sig om symptomer, som du normalt ville forbinde med hepatitis B-infektion.
English: • Children given emtricitabine very commonly experienced changes in skin colour including
Danish: • Hos børn, der får emtricitabin, er det meget almindeligt at opleve ændringer i hudfarven, herunder Pletvis mørkfarvning af huden
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.
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: This is because the active substances in this medicine pass into human breast milk.
Danish: Zentiva, fordi de aktive stoffer i denne medicin udskilles i mælken hos mennesker.
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-phosphat-koncentrationen.
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 3 af disse patienter et klinisk betydningsfuldt fald i estimeret GFR, som blev forbedret efter seponering af tenofovirdisoproxil.
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: Mean change from baseline in CD4 cell count (cells/mm3) p-value
Danish: Middel ændring fra baseline i CD4-celletal (celler/mm3) p-værdi
English: • liver and pancreas problems.
Danish: • problemer med lever og bugspytkirtel.
English: The mean changes in CD4 cell count from baseline were +185 cells/mm3 and +196 cells/mm3, respectively.
Danish: Middelændringerne i CD4-celletallet fra baseline var henholdsvis +185 celler/mm3 og+196 celler/mm3.
English: Eight of the 89 patients (9.0%) discontinued study drug due to renal adverse events.
Danish: 8 af de 89 patienter (9%) fik seponeret studiemedicinen på grund af nyrebivirkninger.
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: • If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of therapy with Emtricitabine/Tenofovir disoproxil Zentiva to you and your child.
Danish: • Hvis du bliver gravid eller planlægger at blive gravid, skal du kontakte din læge for at drøfte de potentielle fordele og risici, som behandling med Emtricitabine/Tenofovir disoproxil Zentiva indebærer for dig og dit barn.
English: Therefore, the same problems may be seen if Emtricitabine/Tenofovir disoproxil Zentiva is administered with a third nucleoside analogue.
Danish: De samme problemer kan derfor muligvis optræde, hvis Emtricitabine/Tenofovir disoproxil Zentiva administreres sammen med en tredje nukleosidanalog.
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: Administration 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 administration i fastende tilstand.
English: Ask your doctor if you have any more questions about how to prevent getting HIV or spreading HIV to other people.
Danish: Spørg din læge, hvis du har flere spørgsmål om, hvordan du kan undgå at få HIV eller sprede HIV til andre mennesker.
English: • swelling of the face, lips, tongue or throat,
Danish: • hævelse i ansigt, læber, tunge eller svælg
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 du tager et andet lægemiddel til behandling af HIV-infektion, som kaldes en proteasehæmmer, vil din læge muligvis bestille blodprøver for at overvåge nyrefunktionen nøje.
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: 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: Emtricitabine/Tenofovir disoproxil Zentiva 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: Emtricitabine/Tenofovir disoproxil Zentiva 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: Film coating: polyvinyl alcohol, titanium dioxide, macrogol, talc, indigo carmine aluminum lake (E 132).
Danish: Filmovertræk: polyvinylalkohol, titandioxid, macrogol, talcum, indigotin (E 132).
English: Patients infected with HBV who discontinue Emtricitabine/Tenofovir disoproxil Zentiva should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Danish: Patienter, som er inficeret med HBV, og som seponerer Emtricitabine/Tenofovir disoproxil Zentiva, bør monitoreres nøje med både klinisk og laboratoriemæssig opfølgning i flere måneder, efter at behandlingen er stoppet.
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: 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 tenofovir-koncentrationsområdet på 0,01 til 25 µg/ml.
English: • If you are being treated for HIV infection, your doctor will prescribe Emtricitabine/Tenofovir disoproxil Zentiva with other antiretroviral medicines.
Danish: • Hvis du bliver behandlet for HIV-infektion, vil din læge vil ordinere Emtricitabine/Tenofovir disoproxil Zentiva sammen med andre antiretrovirale lægemidler.
English: 32 (9 to 55)
Danish: 32 (9% til 55)
English: These infections make it easier for HIV to infect you.
Danish: Disse infektioner gør dig mere modtagelig for HIV.
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 9 ml/min/1,73 m².
English: Baseline characteristics are summarised in Table 5.
Danish: Baselinekarakteristika er opsummeret i Tabel 5.
English: • problems with digestion resulting in discomfort after meals, feeling bloated, flatulence,
Danish: • problemer med fordøjelsen, som resulterer i ubehag efter måltider, oppustethed, afgang af tarmluft
English: HIV-1 infected patients receiving Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva 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 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 dette 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: • If you have hepatitis B, it is especially important not to stop your Emtricitabine/Tenofovir disoproxil Zentiva treatment without talking to your doctor first.
Danish: • Hvis du har hepatitis B, er det særlig vigtigt ikke at ophøre med behandlingen med Emtricitabine/Tenofovir disoproxil Zentiva uden først at konsultere din læge.
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på tabletbeholderen og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • palpitations, tremor or hyperactivity.
Danish: • hjertebanken, rysten (tremor) eller hyperaktivitet.
English: Age (Yrs), Median (Q1, Q3) Gender, N (%)
Danish: Alder (år), Median (1. kvartil, 3. kvartil) Køn, N (%)
English: Cmin: NC Tenofovir:
Danish: Cmin: IB Tenofovir:
English: • Lactic acidosis (see Possible serious side effects)
Danish: • laktatacidose (se Alvorlige bivirkninger)
English: Store below 30°C after first opening.
Danish: Opbevares ved temperaturer under 30 °C efter åbning.
English: Hispanic/Latino Ethnicity, N (%) Sexual Risk Factors at Screening Number of Partners Previous 12 Weeks, Mean (SD) URAI Previous 12 Weeks, N (%) URAI with HIV+ (or unknown status) Partner Previous 6 Mos, N
Danish: Spansk/latinamerikansk etnicitet, N (%) Seksuelle risikofaktorer ved screening Antal partnere i de forudgående 12 uger, middel (SD) URAI forudgående 12 uger, N (%) URAI med HIV+ (er ukendt status) partner forudg.
English: • feeling weak.
Danish: • svaghedsfølelse.
English: Tablet core: microcrystalline cellulose, croscarmellose sodium, talc, hydrophobic colloidal silica, magnesium stearate.
Danish: Tabletkerne: mikrokrystallinsk cellulose, croscarmellosenatrium, talcum, hydrofob kolloid silica, magnesiumstearat.
English: Therefore, a careful benefit-risk assessment is needed when Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva anvendes til patienter med kreatininclearance < 60 ml/min, og nyrefunktionen bør monitoreres omhyggeligt.
English: HIV-Negative Matched Control Subjects 63 (44%) a Relative risk reduction calculated on incident (post-baseline) seroconversion from the double-blind treatment period and through the 8-week follow-up period.
Danish: HIV-negative matchede kontrolpersoner a Relativ risikoreduktion beregnet for hændelsen (post-baseline) serokonvertering fra den dobbeltblinde behandlingsperiode og igennem den otte uger lange opfølgningsperiode.
English: Didanosine/emtricitabine
Danish: Didanosin/Emtricitabin
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: 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: Et 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: • back pain caused by kidney problems.
Danish: • rygsmerter på grund af nyreproblemer.
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 Zentiva 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 Zentiva til ældre mennesker.
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 et forhøjet indhold af lipider og glucose i blodet.
English: At week 48, six adolescents in the tenofovir disoproxil group and one adolescent in the placebo group had significant lumbar spine BMD loss (defined as > 4% loss).
Danish: I uge 48 havde seks unge i gruppen, der fik tenofovirdisoproxil, og en ung i placebogruppen signifikante fald i BMD i lænderygsøjlen (defineret som fald på > 4%).
English: In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density (BMD) of the hip and spine were observed in both treatment groups.
Danish: I et 144-ugers kontrolleret, klinisk studie, hvor tenofovirdisoproxil blev sammenlignet med stavudin i kombination med lamivudin og efavirenz hos antiretroviral-naive patienter, blev der observeret små fald i knoglemineraltætheden (bone mineral density, BMD) i hoften og i rygsøjlen i begge behandlingsgrupper.
English: If you accidentally take more than the recommended dose of Emtricitabine/Tenofovir disoproxil Zentiva, contact your doctor or nearest emergency department for advice.
Danish: Hvis du ved et uheld tager mere end den anbefalede dosis Emtricitabine/Tenofovir disoproxil Zentiva, skal du kontakte lægen eller den nærmeste skadestue for at få råd.
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 Zentiva should be delayed for at least one month and HIV-1 status reconfirmed before starting Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva udsættes mindst en måned og HIV 1-status bekræftes før påbegyndelse af Emtricitabine/Tenofovir disoproxil Zentiva som profylakse før eksponering.
English: Hepatobiliary disorders Common elevated serum aspartate aminotransferase (AST) and/or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia increased transaminases
Danish: forhøjet serum-aspartataminotransferase (ASAT) og/eller forhøjet serum-alanin-aminotransferase (ALAT), hyperbilirubinæmi forhøjede aminotransferaser
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Emtricitabine/Tenofovir disoproxil Zentiva in either adolescent patients for the treatment of HIV-1 infection or in adults and adolescents for PrEP are provided with a physician educational pack containing the Summary of Product Characteristics and an appropriate educational brochure, as detailed below:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som forventes at ordinere/anvende Emtricitabine/Tenofovir disoproxil Zentiva til enten unge patienter til behandling af HIV 1-infektion eller til voksne og unge til behandling af PrEP, er forsynet med en undervisningspakke for læger, der indeholder produktresuméet og en passende undervisningsbrochure som beskrevet nedenfor:
English: Importance of adherence
Danish: Betydning af adhærens: