FrancophonIA/ELRC3.0 huggingface dataset:
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: Serokonverteringer / N Relativ risikoreduktion (95% CI)b a P-værdier efter logrank test. P-værdien for URAI henviser til den nulhypotese, at virkningen var forskellig mellem undergruppestrata (URAI, ingen URAI).
English: Therefore, a careful benefit-risk assessment is needed when Truvada 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 Truvada anvendes til patienter med kreatininclearance < 60 ml/min, og nyrefunktionen bør monitoreres omhyggeligt.
English: − Truvada should always be used combined with other medicines to treat HIV infection.
Danish: − Truvada skal altid anvendes sammen med anden medicin til behandling af HIVinfektion.
English: Patients in the emtricitabine and tenofovir disoproxil group were given Truvada and efavirenz from week 96 to week 144.
Danish: Patienterne i emtricitabin- og tenofovirdisoproxil-gruppen fik Truvada og efavirenz fra uge 96 til uge 144.
English: • Provides information on how to take Truvada
Danish: • Give oplysninger om, hvordan Truvada tages
English: The recommended dose of Truvada to treat HIV is:
Danish: Den anbefalede dosis af Truvada til behandling af HIV er:
English: Do not take Truvada to reduce your risk unless you are confirmed to be HIV negative.
Danish: De må ikke tage Truvada for at nedsætte Deres risiko, medmindre det er bekræftet, at De er HIV-negativ.
English: • PrEP educational brochure for the individual at risk entitled ‘Important Information About
Danish: • PrEP-undervisningsbrochure for personer i risikogruppe med titlen ”Vigtige oplysninger om
English: It is preferable that Truvada is taken with food.
Danish: Truvada skal helst tages sammen med mad.
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 these symptoms tell your doctor.
Danish:  Hvis De bemærker nogen af disse symptomer, skal De fortælle det til lægen.
English: Truvada has not been studied in patients over 65 years of age.
Danish: Truvada er ikke blevet undersøgt hos patienter over 65 år.
English: Pharmacokinetic studies have not been performed with Truvada in children and adolescents (under 18 years of age).
Danish: Der er ikke udført farmakokinetiske studier med Truvada hos børn og unge (under 18 år).
English: Patients infected with HBV who discontinue Truvada 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 Truvada, bør monitoreres nøje med både klinisk og laboratoriemæssig opfølgning i flere måneder, efter at behandlingen er stoppet.
English: Truvada alone does not constitute a complete regimen for the treatment of HIV-1 and HIV-1 resistance mutations have emerged in individuals with undetected HIV-1 infection who are only taking Truvada.
Danish: Truvada udgør ikke i sig selv et komplet regime til behandling af HIV 1, og der er fremkommet HIV 1-resistente mutationer hos personer med uopdaget HIV 1-infektion, der kun tager Truvada.
English: Truvada film-coated tablets are blue, capsule-shaped tablets, engraved on one side with the word “GILEAD” and on the other side with the number “701”.
Danish: Truvada filmovertrukne tabletter er blå, kapselformede tabletter, på den ene side præget med ordet „GILEAD“ og på den anden side med tallet „701“.
English: Some patients taking combination antiretroviral medicines such as Truvada 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 Truvada, kan udvikle en knoglesygdom, der hedder knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
English: HIV-1 infected patients receiving Truvada 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 Truvada 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:  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: Seroconversions / Na Incidence per 100 person-years (95% CI)
Danish: Serokonverteringer / Na Forekomst pr. 100 personår (95% CI)
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Truvada 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 Truvada 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: Possible side effects: Very common side effects
Danish: Bivirkninger: Meget almindelige bivirkninger
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: Treatment of HIV-1 infection in the paediatric population There are no clinical studies conducted with Truvada 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 Truvada hos den pædiatriske population med HIV 1-infektion.
English: • increased creatine kinase
Danish: • forhøjet kreatinkinase
English: The risk of HIV-1 infection should be balanced against the potential for renal and bone effects with long-term use of Truvada.
Danish: Risikoen for HIV 1-infektion bør afvejes mod muligheden for påvirkning af nyrer og knogler ved langtidsbehandling med Truvada.
English: Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of HIV-1 infection if it becomes necessary to discontinue or modify the dose of one of the components of Truvada.
Danish: Der findes separate præparater med emtricitabin og tenofovirdisoproxil til behandling af HIV 1infektion, hvis det bliver nødvendigt at seponere eller ændre dosen af ét af Truvadas indholdsstoffer.
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: 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 1infektion med CrCl 60-80 ml/min.
English: Truvada [Outer packaging only]
Danish: Truvada [kun på den ydre emballage]
English: Therefore the use of Truvada may be considered during pregnancy, if necessary.
Danish: Hvis det er indiceret, kan anvendelse af Truvada derfor overvejes under graviditet.
English: A multidisciplinary approach is recommended to weigh the benefit/risk balance of the use of Truvada 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 afveje benefit/risk-forholdet ved brugen af Truvada 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: The safety and efficacy of Truvada for pre-exposure prophylaxis in patients with HBV or HCV infection has not been established.
Danish: Sikkerheden og virkningen af Truvada som proylakse før eksponering hos patienter med HBV- eller HCV-infektion er ikke fastlagt.
English: Moreover, the reversibility of renal toxicity after cessation of tenofovir disoproxil for treatment of HIV-1 or after cessation of Truvada for pre-exposure prophylaxis cannot be fully ascertained.
Danish: Reversibiliteten af nefrotoksicitet efter afbrydelse af tenofovirdisoproxil i behandlingen af HIV 1, eller efter afbrydelse af Truvada ved profylakse før eksponering, kan desuden ikke fastlægges fuldt ud.
English: If Truvada is used with nephrotoxic medicinal products, renal function should be closely monitored according to the recommended schedule
Danish: Hvis Truvada anvendes sammen med nefrotoksiske lægemidler, skal nyrefunktionen monitoreres omhyggeligt i overensstemmelse med den anbefalede tidsplan
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 studiet var at opnå og vedligeholde bekræftede HIV 1-rna-koncentrationer < 400 kopier/mL i 48 uger.
English: The safety and efficacy of Truvada have not been established in patients with significant underlying liver disorders.
Danish: Truvadas sikkerhed og virkning er ikke blevet fastslået hos patienter med signifikante underliggende leversygdomme.
English: Renal function (creatinine clearance and serum phosphate) should be evaluated prior to initiating Truvada 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 Truvada 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: 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 Truvada have not been specifically established in patients with chronic HBV infection.
Danish: Tenofovirdisoproxil er indiceret til behandling af HBV, og emtricitabin har udvist aktivitet over for HBV i farmakodynamiske studier, men Truvadas sikkerhed og virkning er ikke blevet specifikt fastslået hos patienter med kronisk HBV-infektion.
English: Contents of the pack and other information What Truvada contains
Danish: Pakningsstørrelser og yderligere oplysninger Truvada indeholder
English: The increased dose interval for Truvada in HIV-1 infected patients with moderate renal impairment is expected to result in higher peak plasma concentrations and lower Cmin levels as compared to patients with normal renal function.
Danish: Det øgede dosisinterval for Truvada hos HIV 1-inficerede patienter med moderat nedsat nyrefunktion forventes at resultere i højere peak-plasmakoncentrationer og lavere Cmin-niveauer sammenlignet med patienter med normal nyrefunktion.
English: HIV-1 uninfected individuals should be counselled at frequent intervals to strictly adhere to the recommended Truvada daily dosing schedule.
Danish: Personer uden HIV 1-infektion skal med jævne mellemrum tilrådes at overholde den anbefalede daglige Truvada-doseringsplan meget nøje.
English: As Truvada contains emtricitabine and tenofovir disoproxil, any interactions that have been identified with these agents individually may occur with Truvada.
Danish: Da Truvada indeholder emtricitabin og tenofovirdisoproxil, kan interaktioner, som er identificeret med disse lægemidler individuelt, forekomme med Truvada.
English: Do not miss any doses of Truvada, or stop taking it.
Danish: Lad være med at springe Truvada-doser over eller holde op med at tage Truvada.
English: The adverse reactions considered at least possibly related to treatment with the components of Truvada 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 i Truvada fra kliniske studier og erfaringer hos HIV 1-inficerede patienter efter markedsføring er opført i Tabel 3, nedenfor, efter systemorganklasse og frekvens.
English: The safety and efficacy of Truvada in children under the age of 12 years have not been established.
Danish: Sikkerheden og virkningen af Truvada hos børn under 12 år er ikke klarlagt.
English: The rate of HIV-1 seroconversion in males was 0.24/100 person-years of Truvada exposure and the rate of HIV-1 seroconversion in females was 0.95/100 person-years of Truvada exposure.
Danish: Forekomsten af HIV 1-serokonvertering hos mænd var 0,24/100 personår med Truvada-eksponering og forekomsten af HIV 1-serokonvertering hos kvinder var 0,95/100 personår med Truvada-eksponering.
English: Discontinuation of Truvada therapy in patients infected with HBV may be associated with severe acute exacerbations of hepatitis.
Danish: Seponering af Truvada hos patienter, der er inficeret med HBV, kan være forbundet med svær, akut forværring af hepatitis.
English: • That Truvada may cause a reduction in BMD and the effects of Truvada associated changes in BMD on long-term bone health and future fracture risk are currently unknown in paediatric patients
Danish: • At Truvada kan give anledning til et fald i BMD, og at indvirkningen på knoglesundheden på langt sigt og på den fremtidige frakturrisiko af de ændringer i BMD, der forbindes med Truvada, p.t. ikke er kendt hos pædiatriske patienter
English: Truvada should not be initiated in paediatric patients with renal impairment and should be discontinued in paediatric patients who develop renal impairment during Truvada use.
Danish: Truvada bør ikke initieres hos pædiatriske patienter med nedsat nyrefunktion, og Truvada bør seponeres hos pædiatriske patienter, der udvikler nedsat nyrefunktion under brugen.
English: Interrupting use of Truvada should also be considered in case of progressive decline of renal function when no other cause has been identified.
Danish: Afbrydelse af brugen af Truvada bør også overvejes i tilfælde af progredierende nedsat nyrefunktion, når ingen anden årsag er blevet påvist.
English: • That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil fumarate-containing products such as Truvada
Danish: • At der er en øget risiko for nyresygdom hos HIV-inficerede patienter ved præparater, der indeholder tenofovirdisoproxilfumarat, såsom Truvada
English:  Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection
Danish:  Hvis De lægger mærke til nye eller usædvanlige symptomer efter behandlingens ophør, skal De omgående oplyse Deres læge herom, især hvis det drejer sig om symptomer, som De normalt ville forbinde med hepatitis B-infektion.
English: • Take Truvada every day to reduce your risk, not just when you think you have been at risk of HIV infection.
Danish: • Tag Truvada hver dag for at reducere Deres risiko, ikke kun når De mener, at De har været udsat at få for HIV-infektion.
English: • Reminders on what the individual should know before and while taking Truvada to reduce the risk of getting HIV infection
Danish: • Påmindelse om, hvad den pågældende skal vide før og under indtagelse af Truvada for at nedsætte risikoen for at få HIV-infektion
English: • Children commonly experienced low red blood cell count (anaemia).
Danish: • Hos børn er det almindeligt at opleve et lavt antal røde blodlegemer (anæmi)
English: Do not stop taking Truvada • If you take Truvada for treatment of HIV infection, stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Danish: Hold ikke op med at tage Truvada • Hvis De tager Truvada for behandling af HIV-infektion, kan det nedsætte effektiviteten af den behandling mod HIV, som Deres læge anbefaler, hvis De stopper med at tage tabletterne.
English: Prior to initiating Truvada for the treatment of HIV-1 infection or for use in pre-exposure prophylaxis, it is recommended that creatinine clearance is calculated in all individuals.
Danish: Inden påbegyndelse af Truvada til behandling af HIV 1-infektion eller til brug som profylakse før eksponering anbefales det at beregne kreatininclearance hos alle personer.
English: Truvada comes in bottles of 30 tablets.
Danish: Truvada leveres i tabletbeholder, der indeholder 30 tabletter.
English: Truvada has not been studied in individuals over the age of 65 years.
Danish: Truvada er ikke blevet undersøgt hos personer over 65 år.
English: o Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
Danish: Brug kondom for at reducere kontakten med sæd, vaginalvæsker og blod.
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: • If you are taking Truvada to reduce the risk of getting HIV, do not stop taking Truvada or miss any doses.
Danish: • Hvis De tager Truvada for at nedsætte risikoen for at få HIV, må De ikke holde op med at tage Truvada eller springe en dosis over.
English: Truvada should only be used to reduce the risk of acquiring HIV-1 in individuals confirmed to be HIV negative (see section 4.3).
Danish: Truvada bør kun anvendes til at mindske risikoen for at få HIV 1 hos personer, der bekræftes at være HIV-negative (se pkt.
English: Pre-exposure prophylaxis: No new adverse reactions to Truvada were identified from two randomised placebo-controlled studies (iPrEx, Partners PrEP) in which 2,830 HIV-1 uninfected adults received Truvada once daily for pre-exposure prophylaxis.
Danish: Profylakse før eksponering: Der blev ikke identificeret nogen nye bivirkninger fra Truvada i to randomiserede placebokontrollerede studier (iPrEx, Partners PrEP), hvor 2.830 voksne uden HIV 1infektion fik Truvada én gang dagligt som profylakse før eksponering.
English: What you need to know before you take Truvada Do not take Truvada to treat HIV or to reduce the risk of getting HIV if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal De vide, før De begynder at tage Truvada Tag ikke Truvada for at behandle HIV eller nedsætte risikoen for at få HIV, hvis De er allergisk over for emtricitabin, tenofovir, tenofovirdisoproxil, eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Danish: 3 Studiet blev udført med yderligere voxilaprevir 100 mg for at opnå de forventede voxilaprevir-eksponeringer hos
English: Seroconversions / Nb a ‘Case' = HIV seroconverter; ‘Cohort' = 100 randomly selected subjects from each of the tenofovir disoproxil 245 mg and Truvada groups.
Danish: Serokonverteringer / Nb a ‘Case' = personer med HIV-serokonvertering; ‘Kohorte' = 100 tilfældigt udvalgte forsøgspersoner fra hver af tenofovirdisoproxil 245 mg- og Truvada-grupperne.
English: Renal safety with Truvada has only been studied to a very limited degree in HIV-1 infected patients with impaired renal function (creatinine clearance < 80 mL/min).
Danish: Truvadas renale sikkerhed er kun blevet undersøgt i meget begrænset omfang hos HIV 1-inficerede patienter med nedsat nyrefunktion (kreatininclearance < 80 ml/min).
English: • Provides information on how to store Truvada.
Danish: • Give oplysninger om, hvordan Truvada opbevares.
English: Pre-exposure prophylaxis in the paediatric population The efficacy and safety of Truvada for pre-exposure prophylaxis in adolescents who adhere to daily dosing is expected to be similar to that in adults at the same level of adherence.
Danish: Profylakse før eksponering hos den pædiatriske population Truvadas sikkerhed og virkning ved profylakse før eksponering hos unge som adhærerer til daglig dosering forventes at være den samme som for voksne med det samme adhærensniveau.
English: Individuals should be re-confirmed to be HIV-negative at frequent intervals (e.g. at least every 3 months) using a combined antigen/antibody test while taking Truvada for pre-exposure prophylaxis.
Danish: De skal testes for stadig at være HIV-negative med hyppige mellemrum (f.eks. mindst hver 3. måned) ved hjælp af en kombineret antigen/antistof-test, så længe de tager Truvada som profylakse før eksponering.
English: Truvada contains two active substances, emtricitabine and tenofovir disoproxil.
Danish: Truvada indeholder to aktive stoffer, emtricitabin og tenofovirdisoproxil.
English: − Truvada can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.
Danish: − Truvada kan administreres i stedet for emtricitabin og tenofovirdisoproxil anvendt hver for sig med samme doser.
English: In a study of 498 men, the mean changes from baseline to week 24 in BMD ranged from -0.4% to -1.0% across hip, spine, femoral neck and trochanter in men who received daily Truvada prophylaxis (n = 247) vs. placebo (n = 251).
Danish: I et studie med 498 mænd varierede middelændringerne i BMD fra baseline til uge 24 fra -0,4% til -1,0% i hoften, rygsøjlen, lårbenshalsen og trochanter hos mænd, der fik daglig Truvada-profylakse (n = 247) versus placebo (n = 251).
English: Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Truvada with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Danish: Lægemidler, som udskilles gennem nyrerne: Da emtricitabin og tenofovir primært udskilles gennem nyrerne, kan administration af Truvada sammen med lægemidler, der reducerer nyrefunktionen eller konkurrerer om aktiv tubulær sekretion (f.eks. cidofovir) øge serumkoncentrationerne af emtricitabin, tenofovir og/eller de samtidigt administrerede lægemidler.
English: Interrupting treatment with Truvada should also be considered in case of progressive decline of renal function when no other cause has been identified.
Danish: Det bør også overvejes at afbryde behandlingen med Truvada i tilfælde af progredierende fald i nyrefunktionen, når ingen anden årsag er blevet identificeret.