FrancophonIA/ELRC3.0 huggingface dataset:
English: This indicates that active tubular secretion is an important part of the elimination of tenofovir.
Danish: Dette angiver, at aktiv tubulær sekretion udgør en vigtig del af eliminationen af tenofovir.
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i den originale emballage for at beskytte mod fugt.
English: • Recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment
Danish: • Anbefalet skema for monitorering af nyrefunktion, med hensyntagen til tilstedeværelsen eller fraværet af yderligere risikofaktorer for nedsat nyrefunktion
English: NA 5.14% 8.08% 10.05% 11.21%
Danish: NA NA 5,14 % 8,08 % 10,05 % 11,21 %
English: • increased creatinine in your blood,
Danish: • øget kreatinin i blodet
English: Moreover, the reversibility of renal toxicity cannot be fully ascertained.
Danish: Desuden kan reversibiliteten af nyretoksicitet ikke helt sikres.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 September 2016
Danish: Dato for første markedsføringstilladelse: 15. september 2016
English: k One patient in this group became HBsAg negative for the first time at the 240 week visit and was ongoing in the study at the time of the data cut-off.
Danish: Én patient i denne gruppe blev HBsAg-negativ for første gang ved uge 240-besøget og var stadig i studiet på skæringsdagen for dataindsamling.
English: Week 192
Danish: Uge 192
English: • If you have taken Tenofovir disoproxil Zentiva during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: • Hvis du har taget Tenofovir disoproxil Zentiva under din graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: Following intravenous administration the steady-state volume of distribution of tenofovir was estimated to be approximately 800 ml/kg.
Danish: Efter intravenøs administration blev steady-state distributionsvolumenet af tenofovir vurderet til at være ca. 800 ml/kg.
English: The adverse reactions with suspected (at least possible) relationship to treatment are listed below by body system organ class and frequency.
Danish: Bivirkninger med mistænkt (eller i det mindste en mulig) forbindelse med behandling er anført nedenfor efter systemorganklasse og hyppighed.
English: Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine
Danish: Din læge vil nøje tage stilling til, om det er nødvendigt at behandle dig med kombinationer af tenofovir og didanosin.
English: Co-administration and risk of renal toxicity The same recommendations apply as in adults (see above).
Danish: Samtidig administration og risiko for nyretoksicitet De samme anbefalinger gælder som for voksne (se ovenfor).
English: • Adults: One tablet each day with food (for example, a meal or a snack).
Danish: • Voksne: 1 tablet en gang dagligt med mad (for eksempel et måltid eller et mellemmåltid).
English: • adolescents aged 12 to less than 18 years.
Danish: • unge i alderen 12 til under 18 år.
English: Efavirenz or lamivudine resistance either preceded or was coincident with the development of K65R in all cases.
Danish: Efavirenz- eller lamivudinresistens opstod enten forud for eller samtidig med udviklingen af K65R i alle tilfælde.
English: However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Danish: Der var imidlertid ingen øget risiko for frakturer eller tegn på klinisk relevante knogleabnormiteter over et tidsrum på 144 uger.
English: Interaction with didanosine
Danish: Interaktion med didanosin
English: Table 7: Safety and efficacy parameters in decompensated patients at week 48
Danish: Tabel 7: Sikkerheds- og virkningsparametre hos dekompenserede patienter ved uge 48
English: • If it is less than 12 hours after it is usually taken, take it as soon as you can, and then take your next dose at its regular time.
Danish: • Hvis det er mindre end 12 timer efter, dosis normalt tages, skal du tage den så hurtigt som muligt og derefter tage den næste dosis på det normale tidspunkt.
English: U Kabelovny 130 102 37 Prague 10 Czech Republic
Danish: U Kabelovny 130 102 37 Prag 10 Tjekkiet
English: Post-treatment exacerbations are usually associated with rising HBV DNA, and the majority appears to be self-limited.
Danish: En eksacerbation efter behandlingen er normalt forbundet med stigning i HBV-DNA, og størstedelen af tilfældene forekommer at være selvbegrænsende.
English: These reactions are usually mild to moderate gastrointestinal events.
Danish: Disse bivirkninger er som regel lette til moderate gastrointestinale symptomer.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Du kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.
Danish: Du kan også smitte med hiv og HBV, så det er vigtigt at tage forholdsregler for at undgå at smitte andre.
English: • If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of your antiretroviral therapy to you and your child.
Danish: • Hvis du bliver gravid eller planlægger at blive gravid, skal du kontakte din læge for at drøfte de potentielle fordele og risici, som din antiretrovirale behandling indebærer for dig og dit barn.
English: Week 72
Danish: Uge 72
English: All adverse reactions are presented in Table 2.
Danish: Alle bivirkninger vises i tabel 2.
English: Reproductive 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 have hepatitis B infection, your doctor will carefully consider the best treatment for you.
Danish: Hvis du har en hepatitis B-infektion, vil din læge nøje overveje, hvilken behandling, der er den bedste for dig.
English: • You must not take Tenofovir disoproxil Zentiva during pregnancy unless specifically discussed with your doctor.
Danish: • Du må ikke tage Tenofovir disoproxil Zentiva under graviditeten, medmindre du specifikt har drøftet dette med din læge.
English: Following oral administration the terminal half-life of tenofovir is approximately 12 to 18 hours.
Danish: Efter oral indgivelse er den terminale halveringstid af tenofovir ca. 12 til 18 timer.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Ud over de opportunistiske infektioner kan autoimmune lidelser (skyldes, at immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hivinfektion.
English: Study 174-0103 (HBeAg positive)
Danish: Studie 174-0103 (HBeAg positiv)
English: Renal function (creatinine clearance and serum phosphate) should be evaluated prior to treatment, and monitored during treatment as in adults (see above).
Danish: Nyrefunktion (kreatininclearance og serumphosphat) bør evalueres før behandling og monitoreres under behandlingen som for voksne (se ovenfor).
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Danish: • For de børn, hvis mødre har taget NRTI'er i løbet af graviditeten, opvejede fordelen ved beskyttelse mod hiv risikoen ved bivirkningerne.
English: The decision to treat paediatric patients (adolescents) should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information.
Danish: Beslutningen om behandling af pædiatriske patienter (unge) skal ske på baggrund af omhyggelige overvejelser af den individuelle patients behov og i betragtning af aktuelle retningslinjer for behandling af pædiatriske patienter, herunder værdien af histologiske oplysninger ved baseline.
English: Therefore, a multidisciplinary approach is recommended to adequately weigh on a case by case basis the benefit/risk balance of treatment, decide the appropriate monitoring during treatment (including decision for treatment withdrawal) and consider the need for supplementation.
Danish: Derfor anbefales en multidisciplinær fremgangsmåde for på tilstrækkelig vis at afveje balancen mellem risici og fordele ved behandlingen for hver enkelt patient, bestemme hensigtsmæssig monitorering i løbet af behandlingen (herunder en beslutning om at seponere behandlingen) og overveje behovet for tilskud.
English: Study 174-0102 (HBeAg negative)
Danish: Studie 174-0102 (HBeAg negativ)
English: *Generally, once weekly dosing assuming three haemodialysis sessions per week, each of approximately 4 hours duration or after 12 hours cumulative haemodialysis.
Danish: * Generelt forudsætter én ugentlig dosis tre hæmodialysesessioner om ugen, hver af ca. 4 timers varighed eller efter 12 timers kumulativ hæmodialyse.
English: These renal transport proteins may be responsible for tubular secretion and in part, renal elimination of tenofovir and cidofovir.
Danish: Disse renale transportproteiner (hOAT1) kan være ansvarlige for tubulær sekretion og til dels for renal elimination af tenofovir og cidofovir.
English: One patient in the tenofovir disoproxil arm developed the K70E substitution in the virus.
Danish: En patient i armen med tenofovirdisoproxil udviklede K70E-substitutionen i virusset.
English: The following side effects are uncommon (may affect up to 1 in 100 people): • breakdown of muscle, muscle pain or weakness.
Danish: Følgende bivirkninger er ikke almindelige (kan opstå hos op til 1 ud af 100 personer): • nedbrydning af muskelvæv, smerter eller svaghed i musklerne
English: Tenofovir is also active against HIV-1 subtypes A, C, D, E, F, G, and O and against HIVBaL in primary monocyte/macrophage cells.
Danish: Tenofovir er også aktivt mod hiv 1-subtyperne A, C, D, E, F, G og O og mod hivBaL ved primære monocyt-/makrofagceller.
English: abdominal pain, abdominal distension, flatulence
Danish: abdominalsmerter, abdominal distension, flatulens
English: Exacerbations of hepatitis during treatment
Danish: Hepatitis-eksacerbationer under behandlingen
English: Decreases in BMD of hip were significantly greater in this group until 96 weeks.
Danish: I denne gruppe var reduktionerne i BMD i hoften signifikant større indtil uge 96.
English: The K65R mutation occurred in a slightly higher percentage of patients in the tenofovir disoproxil group than the active control group (2.7% versus 0.7%).
Danish: K65R-mutationen sås hos en lidt højere procentdel af patienter i tenofovirdisoproxil-gruppen end den aktive kontrolgruppe (2,7 % versus 0,7 %).
English: From both the genotypic and phenotypic analyses there was no evidence for other pathways of resistance to tenofovir.
Danish: Fra både genotype- og fænotypeanalyser har der ikke været nogle tegn på andre veje for resistens over for tenofovir.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1127/001 30 film-coated tablets EU/1/16/1127/002 90 (3x30) film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1127/001 30 filmovertrukne tabletter EU/1/16/1127/002 90 (3x30) filmovertrukne tabletter
English: Your doctor may order blood tests during treatment to monitor how your kidneys work.
Danish: Din læge kan bestille blodprøver under behandlingen for at overvåge, hvordan dine nyrer fungerer.
English: The majority of subjects were either genotypes C (43.8%) or D (41.6%) with a lower and similar frequency of genotypes A and B (6.7% each).
Danish: Størstedelen af forsøgspersonerne var enten genotype C (43,8 %) eller D (41,6 %) med en lavere og sammenlignelig hyppighed af genotype A og B (begge 6,7 %).
English: Medicinal product by therapeutic areas (dose in mg)
Danish: terapeutisk område (dosis i mg)
English: Maximum tenofovir concentrations are observed in serum within one hour of dosing in the fasted state and within two hours when taken with food.
Danish: Maksimale tenofovirkoncentrationer ses i serum inden for 1 time efter dosering i den fastende tilstand og inden for 2 timer efter administration sammen med mad.
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with tenofovir disoproxil.
Danish: En stor mængde data fra gravide kvinder (mere end 1.000 graviditetsudfald) indikerer ingen misdannelser eller føtal/neonatal toksicitet i forbindelse med tenofovirdisoproxil.
English: At weeks 96, 144, 192, 240, 288 and 384, viral suppression, biochemical and serological responses were maintained with continued tenofovir disoproxil treatment (see Tables 4 and 5 below).
Danish: Ved uge 96, 144, 192, 240, 288 og 384 blev viral suppression og biokemisk og serologisk respons opretholdt ved fortsat tenofovirdisoproxil-behandling (se tabel 4 og 5 nedenfor).
English: Interactions between tenofovir disoproxil and other medicinal products are listed in Table 1 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 tenofovirdisoproxil og andre lægemidler ses i tabel 1 nedenfor (stigning er angivet som „↑“, fald som „↓“, ingen ændring som „↔“, to gange dagligt som „b.i.d.“, en gang dagligt som „q.d.“).
English: n/a = not applicable.
Danish: n/a = not applicable ikke relevant.
English: • HBV infected adolescents aged 12 to less than 18 years who weigh at least 35 kg.
Danish: • HBV-inficerede unge i alderen 12 til under 18 år, som vejer mindst 35 kg.
English: The silica gel desiccant is contained in a separate container and should not be swallowed.
Danish: Silicagel-tørremidlet er i en separat beholder og må ikke sluges.
English: These patients may be at higher risk of experiencing serious hepatic or renal adverse reactions.
Danish: Disse patienter kan have højere risiko for at få alvorlige hepatiske eller renale bivirkninger.
English: increased creatinine, proximal renal tubulopathy (including Fanconi syndrome)
Danish: øget kreatinin, proksimal renal tubulopati (herunder Fanconis syndrom)
English: In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Danish: Hos patienter med kompenseret leversygdom er disse stigninger i serum-ALAT generelt hverken ledsaget af en stigning i serum-bilirubin-koncentrationen eller af hepatisk dekompensation.
English: Histological response a,b a The population used for analysis of histology included only patients with available liver biopsy data (Missing = Excluded) by week 240.
Danish: Histologisk respons a,b a Populationen, som blev analyseret histologisk, inkluderede kun patienter med tilgængelige data fra leverbiopsi (manglende = ekskluderet) ved uge 240.
English: Comparisons between treatment groups beyond week 24 are difficult to interpret since investigators had the option to intensify treatment to open-label emtricitabine plus tenofovir disoproxil.
Danish: Sammenligninger mellem behandlingsgrupperne ud over uge 24 er svære at fortolke, da investigatorerne havde muligheden for at intensivere behandlingen til open-label-behandling med emtricitabin plus tenofovirdisoproxil.
English: Liver flares are especially serious, and sometimes fatal in patients with decompensated liver disease.
Danish: En opblussen af leversygdommen er særligt alvorlig og nogle gange letal hos patienter med dekompenseret leversygdom.
English: In vitro studies have determined that neither tenofovir disoproxil nor tenofovir are substrates for the CYP450 enzymes.
Danish: In vitro-studier har afgjort, at hverken tenofovirdisoproxil eller tenofovir er substrater for CYP450enzymerne.
English: If you have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Tenofovir disoproxil Zentiva is started.
Danish: Hvis du har en fremskreden hiv-infektion (aids) og har en infektion, kan du udvikle symptomer på infektion og betændelse eller opleve en forværring af symptomerne på en eksisterende infektion, når behandlingen med Tenofovir disoproxil Zentiva påbegyndes.
English: Co-administration and risk of renal toxicity
Danish: Samtidig administration og risiko for nyretoksicitet
English: The adverse reactions observed with continued treatment for 384 weeks were consistent with the safety profile of tenofovir disoproxil.
Danish: De bivirkninger, der blev observeret ved fortsat behandling i 384 uger, var i overensstemmelse med sikkerhedsprofilen for tenofovirdisoproxil.
English: Non-clinical safety pharmacology studies reveal no special hazard for humans.
Danish: De prækliniske studier af sikkerhedsfarmakologi viser ingen særlig risiko for mennesker.
English: If you have hepatitis B or HIV and hepatitis B together (co-infection), it is very important not to stop your Tenofovir disoproxil Zentiva treatment without talking to your doctor first.
Danish: Hvis du har hepatitis B eller både hiv og hepatitis B samtidig (co-infektion), er det meget vigtigt, at du ikke ophører med behandlingen med Tenofovir disoproxil Zentiva uden først at tale med din læge.
English: Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets.
Danish: Hver tabletbeholder indeholder silicagel-tørremiddel, der skal blive i tabletbeholderen, for at beskytte dine tabletter.
English: • adults
Danish: • voksne
English: However, a benefit is expected for the adolescent population based on extrapolation of adult data and comparative pharmacokinetic data (see section 5.2).
Danish: Der forventes imidlertid en gavnlig effekt for den unge population baseret på ekstrapolation af data fra voksne og sammenlignende farmakokinetiske data (se pkt.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er tegn på, at leversygdommen forværres hos sådanne patienter, skal man overveje at seponere eller foretage et ophold i behandlingen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1127/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1127/001
English: The following side effects may be signs of lactic acidosis:
Danish: Følgende bivirkninger kan være tegn på laktatacidose:
English: n/a= not applicable.
Danish: n/a = not applicable - ikke relevant.
English: Reductions in BMD have been observed in HBV infected paediatric patients 2 to < 18 years of age.
Danish: Reduktioner i BMD er blevet observeret hos HBV-inficerede pædiatriske patienter i alderen 2 til < 18 år.
English: Only five had adefovir-associated resistance mutations at baseline.
Danish: Kun 5 patienter havde mutationer med relation til adefovirresistens ved baseline.
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 bibeholdte < 400 kopier/ml ved uge 48 var hovedsageligt påvirket af det højere antal seponeringer i behandlingsgruppen med tenofovirdisoproxil.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Danish: Tilfælde af osteonekrose er rapporteret, specielt hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig CART.
English: Although there are limited clinical data on the use of Tenofovir disoproxil Zentiva in pregnant women, it is not usually used unless absolutely necessary.
Danish: Selvom der foreligger begrænsede kliniske data om brug af Tenofovir disoproxil Zentiva hos gravide, anvendes Tenofovir disoproxil Zentiva normalt ikke, medmindre det er absolut nødvendigt.
English: At concentrations of up to 300 µmol/l, tenofovir has also shown no effect on the synthesis of mitochondrial DNA or the production of lactic acid in in vitro assays.
Danish: Ved koncentrationer på op til 300 µmol/l har tenofovir tilmed ikke vist effekt på syntesen af mitokondrie-DNA eller produktionen af mælkesyre ved in vitro-analyser.
English: Entecavir (0.5 mg or 1 mg) n = 22
Danish: Entecavir (0,5 mg eller 1 mg) (n = 22)
English: • Bone problems.
Danish: • Knogleproblemer.
English: • Talk to your doctor before you stop taking Tenofovir disoproxil Zentiva for any reason, particularly if you are experiencing any side effects or you have another illness.
Danish: • Tal med din læge, før du holder op med at tage Tenofovir disoproxil Zentiva, uanset årsagen, især hvis du oplever bivirkninger eller har en anden sygdom.
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Tenofovir disoproxil Zentiva.
Danish: Nogle patienter har symptomer på, eller deres blodprøver viser, at deres hepatitis er blevet forværret efter ophør med behandlingen med Tenofovir disoproxil Zentiva.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: [outer packaging only]
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC: [kun på den ydre emballage]
English: • Take care not to infect other people.
Danish: • Tag forholdsregler for at undgå at smitte andre.
English: • If you are an adult and have problems with your kidneys, your doctor may advise you to take Tenofovir disoproxil Zentiva less frequently.
Danish: • Hvis du er voksen og har problemer med dine nyrer, kan din læge råde dig til at tage Tenofovir disoproxil Zentiva mindre hyppigt.
English: You do not have to have HIV to be treated with Tenofovir disoproxil Zentiva for HBV.
Danish: Du behøver ikke nødvendigvis have hiv for at blive behandlet med Tenofovir disoproxil Zentiva for HBV.
English: Data pertaining to HIV
Danish: Data vedrørende hiv
English: If this applies to you, tell your doctor immediately and do not take Tenofovir disoproxil Zentiva.
Danish: Hvis dette gælder for dig, skal du omgående fortælle din læge det og lade være med at tage Tenofovir disoproxil Zentiva.
English: Administration of tenofovir disoproxil with a high fat meal enhanced the oral bioavailability, with an increase in tenofovir AUC by approximately 40% and Cmax by approximately 14%.
Danish: Administration af tenofovirdisoproxil sammen med et fedtholdigt måltid forstærkede den orale biotilgængelighed med en forøgelse i tenofovir AUC med ca. 40 % og Cmax med ca. 14 %.
English: Data pertaining to HBV
Danish: Data vedrørende HBV
English: INFORMATION IN BRAILLE Tenofovir disoproxil Zentiva [outer packaging only]
Danish: INFORMATION I BRAILLESKRIFT Tenofovir disoproxil Zentiva [kun på den ydre emballage]
English: • diarrhoea,
Danish: • diarré
English: Do not reduce the prescribed dose, unless your doctor has told you to do so.
Danish: Tag ikke mindre end den ordinerede dosis, medmindre din læge har sagt, at du skal gøre det.
English: It is not known whether tenofovir can be removed by peritoneal dialysis.
Danish: Det vides ikke, om tenofovir kan fjernes ved peritonealdialyse.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Tenofovir disoproxil Zentiva in adolescent patients 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 (MAH) skal sikre sig, at alle læger, der forventes at udskrive/anvende Tenofovir disoproxil Zentiva til pædiatriske patienter forsynes med en uddannelsespakke til læger, der indeholder produktresuméet og en passende uddannelsesbrochure, som beskrevet nedenfor: