FrancophonIA/ELRC3.0 huggingface dataset:
English: • That there is an increased risk of renal disease in HIV and HBV infected patients associated with tenofovir disoproxil fumarate-containing products such as Viread
Danish: • At der er en øget risiko for nyresygdom hos hiv- og HBV-inficerede patienter forbundet med tenofovirdisoproxilfumarat-indeholdende præparater, såsom Viread
English: Contact your child's doctor or nearest emergency department for advice.
Danish: Kontakt Deres barns læge eller den nærmeste skadestue for at få råd.
English: Response to treatment with tenofovir disoproxil was comparable in nucleos(t)ide-naïve (n = 20) and nucleos(t)ideexperienced (n = 32) patients, including lamivudine-resistant patients (n = 6).
Danish: Behandlingsresponset med tenofovirdisoproxil var sammenligneligt hos nukleos(t)id-naive (n = 20) og nukleos(t)id-erfarne (n = 32) patienter, herunder lamivudin-resistente patienter (n = 6).
English: • Talk to your doctor before you stop taking Viread for any reason, particularly if you are experiencing any side effects or you have another illness.
Danish: • Tal med Deres læge, før De holder op med at tage Viread, uanset årsagen, især hvis De oplever bivirkninger eller har en anden sygdom.
English: Stopping treatment with Viread may reduce the effectiveness of the treatment recommended by your child's doctor.
Danish: Ophør med Viread kan nedsætte virkningen af den behandling, som Deres barns læge har anbefalet.
English: You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.
Danish: De kan også smitte med hiv og HBV, så det er vigtigt at tage forholdsregler for at undgå at smitte andre.
English: Your child can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.
Danish: Deres barn kan også smitte med hiv eller HBV, så det er vigtigt at tage forholdsregler for at undgå at smitte andre.
English: • breakdown of muscle, muscle pain or weakness Tests may also show:
Danish: • nedbrydning af muskelvæv, smerter eller svaghed i musklerne Prøver kan også vise:
English: Eight (2%) tenofovir disoproxil 245 mg treated patients developed the K65R mutation within the first 48 weeks.
Danish: 8 patienter (2%) behandlet med 245 mg tenofovirdisoproxil udviklede K65R mutationen inden for de første 48 uger.
English: These dose adjustments have not been confirmed in clinical studies.
Danish: Disse justeringer af doseringsintervallet er ikke blevet bekræftet i kliniske studier.
English: Subjects must have been naïve to tenofovir disoproxil, but could have received interferon based regimens (> 6 months prior to screening) or any other non-tenofovir disoproxil containing oral anti-HBV nucleoside/nucleotide therapy (> 16 weeks prior to screening).
Danish: Patienterne skulle være behandlingsnaive med hensyn til tenofovirdisoproxil, men kunne have fået interferon-baserede regimer (> 6 måneder før screening) eller anden oral anti-HBV nukleosid/nukleotid-behandling (> 16 uger før screening), der ikke indeholdt tenofovirdisoproxil.
English: In patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min) the daily dose must be adjusted and renal function should be closely monitored (see sections 4.2 and 5.2).
Danish: Hos patienter med moderat eller svært nedsat nyrefunktion (kreatininclearance < 50 ml/min) skal den daglige dosis justeres og nyrefunktionen monitoreres tæt (se pkt.
English: One tablespoon (15 ml) of soft food per one level scoop of granules is required.
Danish: Der kræves en spiseskefuld (15 ml) blød mad pr. strøget måleske granulat.
English: • Other medicines containing didanosine (for HIV infection): Taking Viread with other antiviral medicines that contain didanosine can raise the levels of didanosine in the blood and may reduce CD4 cell counts.
Danish: • Anden medicin, som indeholder didanosin (mod hiv-infektion): Hvis De tager Viread sammen med anden antiviral medicin, som indeholder didanosin, kan det øge indholdet af didanosin i blodet og reducere CD4-celletallet.
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 Viread is started.
Danish: Hvis De har en fremskreden hiv-infektion (aids) og har en infektion, kan De udvikle symptomer på infektion og betændelse eller opleve en forværring af symptomerne på en eksisterende infektion, når behandlingen med Viread påbegyndes.
English: If you are an adult, your doctor may advise you to reduce your daily dose of the granules.
Danish: Hvis De er voksen, kan Deres læge måske råde Dem til at reducere Deres daglige dosis af granulatet.
English: • It is very important to tell your child's doctor if your child is taking other medicines that may damage their kidneys.
Danish: • Det er meget vigtigt at fortælle Deres barns læge det, hvis Deres barn tager anden medicin, som kan skade barnets nyrer.
English: While taking Viread your child may still develop infections or other illnesses associated with HIV infection.
Danish: Mens Deres barn tager Viread, kan Deres barn stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion.
English: • Contact your child's doctor before your child restarts taking Viread tablets.
Danish: • Kontakt Deres barns læge, før Deres barn igen begynder at tage Viread tabletter.
English: Treatment with tenofovir disoproxil 245 mg was also associated with significantly greater proportions of patients with HBV DNA < 400 copies/ml, when compared to adefovir dipivoxil 10 mg treatment.
Danish: Behandlingen med 245 mg tenofovirdisoproxil var også forbundet med signifikant større andele af patienter med HBV-dna < 400 kopier/ml sammenlignet med behandlingen med 10 mg adefovirdipivoxil.
English: • That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving tenofovir disoproxil fumarate, renal function should be re-evaluated within one week.
Danish: • At hvis serumphosphat bekræftes til at være < 3,0 mg/dl (0,96 mmol/l) hos pædiatriske patienter, der får tenofovirdisoproxilfumarat, skal vurderingen af nyrefunktionen gentages inden for en uge.
English: In children whose mothers took medicines like Viread (NRTIs) during pregnancy, the benefit from the protection against the virus outweighed the risk of side effects.
Danish: For de børn, hvis mødre har taget medicin som Viread (NRTI'er) i løbet af graviditeten, opvejede fordelen ved beskyttelse mod virus risikoen ved bivirkningerne.
English: • If your child becomes pregnant, ask your child's doctor about the potential benefits and risks of the antiretroviral therapy to your child and your child's baby.
Danish: • Hvis Deres barn bliver gravid, skal De kontakte Deres barns læge for at drøfte de potentielle fordele og risici, som barnets antiretrovirale behandling indebærer for Deres barn og Deres barns baby.
English: The mean rate of BMD gain was less in the tenofovir disoproxil group compared to the placebo group.
Danish: Den gennemsnitlige hastighed for stigning i BMD var mindre i tenofovirdisoproxil-gruppen sammenlignet med placebogruppen.
English: Viread granules contain mannitol
Danish: Viread granulat indeholder mannitol
English: The recommended dose is 6.5 mg of tenofovir disoproxil per kilogram of body weight once daily taken with food.
Danish: Den anbefalede dosis er 6,5 mg/kg kropsvægt tenofovirdisoproxil en gang dagligt taget sammen med mad.
English: Viread granules should be measured with the supplied dosing scoop.
Danish: Viread granulat skal afmåles med den leverede måleske.
English: • adolescents aged 12 to less than 18 years who have already been treated with other HIV
Danish: • voksne • unge i alderen 12 til under 18 år, som allerede er blevet behandlet med anden hiv-medicin,
English: Use with the supplied dosing scoop.
Danish: Anvendes med den leverede måleske.
English: 6.5 mg/kg granules 2 to < 12 years (n = 23)
Danish: 6,5 mg/kg granulat 2 til < 12 år (n = 23)
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 your child starts taking medicines for the treatment of their HIV infection.
Danish: Ud over de opportunistiske infektioner kan autoimmune lidelser (skyldes, at immunsystemet angriber sundt kropsvæv) også opstå, efter Deres Barn er begyndt at tage medicin til behandling af sin hiv-infektion.
English: All adverse reactions are presented in Table 3.
Danish: Alle bivirkninger vises i tabel 3.
English: A pharmacokinetic study has been performed in non-HIV infected adult patients with various degrees of hepatic impairment.
Danish: Der er udført et farmakokinetisk studie hos voksne patienter uden hiv-infektion med forskellige grader af nedsat leverfunktion.
English: Adults and adolescents aged 12 to < 18 years and weighing ≥ 35 kg:
Danish: Voksne og unge i alderen 12 til < 18 år, der vejer ≥ 35 kg:
English: • If you are allergic to tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine listed in section 6.
Danish: • Hvis De er allergisk over for tenofovir, tenofovirdisoproxil eller et af de øvrige indholdsstoffer i Viread angivet i punkt 6.
English: • If it is more than 12 hours since your child should have taken it, forget about the missed dose.
Danish: • Hvis det er mere end 12 timer siden Deres barn skulle have taget den, skal Deres barn ikke tage den glemte dosis.
English: - The active substance is tenofovir.
Danish: - Aktivt stof: tenofovir.
English: A granules formulation of tenofovir disoproxil is available for patients having difficulty in swallowing film-coated tablets.
Danish: En formulering af tenofovirdisoproxil som granulat fås til patienter, der har problemer med at synke filmovertrukne tabletter.
English: Renal and bone effects in adult population
Danish: Påvirkning af nyrer og knogler hos den voksne population Påvirkning af nyrer
English: Viread 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.
Danish: Viread 245 mg filmovertrukne tabletter er indiceret i kombination med andre antiretrovirale lægemidler til behandling af hiv 1-inficerede voksne.
English: • changes to your child's urine and back pain caused by kidney problems, including kidney failure
Danish: • ændringer i Deres barns urin og rygsmerter på grund af nyreproblemer, inklusive nyresvigt
English: • liver problems
Danish: • problemer med lever
English: • If your child is allergic to tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine listed in section 6.
Danish: • Hvis Deres barn er allergisk over for tenofovir, tenofovirdisoproxil eller et af de øvrige indholdsstoffer i Viread angivet i punkt 6.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om Viread findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Table 11: Mean (± SD) tenofovir pharmacokinetic parameters by age groups for paediatric patients
Danish: Tabel 11: Tenofovirs gennemsnitlige (± SD) farmakokinetiske parametre efter aldersgruppe for pædiatriske patienter
English: Cumulatively, there were 4 patients who experienced a viremic episode (HBV DNA>400 copies/ml) at their last timepoint on tenofovir disoproxil.
Danish: Kumulativt var der 4 patienter, som oplevede en viræmisk episode (HBV-dna > 400 kopier/ml) på det sidste tidspunkt på tenofovirdisoproxil.
English: In adults, the demonstration of the benefit of Viread in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).
Danish: Hos voksne er påvisningen af Vireads gavnlige effekt på hiv 1-infektion baseret på resultaterne fra ét studie med behandlingsnaive patienter, herunder patienter med en høj virusmængde (> 100.000 kopier/ml) og studier, hvor Viread blev føjet til stabil baggrundsterapi (hovedsagelig trestofsbehandling) hos antiretroviralt forbehandlede patienter, som tidligt ikke havde haft virologisk effekt (< 10.000 kopier/ml; hos størstedelen af patienterne < 5.000 kopier/ml).
English: hepatic steatosis, hepatitis Skin and subcutaneous tissue disorders: Very common:
Danish: steatosis hepatis, hepatitis Hud og subkutane væv: Meget almindelig:
English: If a patient misses a dose of Viread within 12 hours of the time it is usually taken, the patient should take Viread with food as soon as possible and resume their normal dosing schedule.
Danish: Hvis en patient glemmer at tage en dosis Viread i mindre end 12 timer efter tidspunktet, hvor patienten normalt tager dosen, skal patienten tage Viread sammen med mad så snart som muligt og derefter fortsætte med den normale doseringsplan.
English: Patients were stratified by baseline HIV-1 RNA and CD4 count.
Danish: Patienter blev stratificeret efter hiv 1-rna og CD4-tal ved baseline.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: De tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: Tenofovir disoproxil should be avoided in antiretroviral-experienced patients with strains harbouring the K65R mutation (see section 4.4).
Danish: Tenofovirdisoproxil bør undgås hos tidligere antiretroviral-behandlede patienter med stammer, som har K65R-mutationen (se pkt.
English: Normal ALT ≥ 2 point decrease in CPT from baseline n (%)
Danish: Normal ALAT ≥ 2 point reduktion i CPT fra baseline n (%)
English: Keep the tablet bottle with you so that you can easily describe what your child has taken.
Danish: Tag tabletbeholderen med, så De let kan vise, hvad Deres barn har taget.
English: • HBV infected children and adolescents aged 2 to less than 18 years.
Danish: • HBV-inficerede børn og unge i alderen 2 til under 18 år.
English: If your child has advanced HIV infection (AIDS) and has an infection, they may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Viread is started.
Danish: Hvis Deres barn har en fremskreden hiv-infektion (aids) og har en infektion, kan barnet udvikle symptomer på infektion og betændelse eller opleve en forværring af symptomerne på en eksisterende infektion, når behandlingen med Viread påbegyndes.
English: There are limited data on the safety and efficacy of tenofovir disoproxil in adult patients with moderate and severe renal impairment (creatinine clearance < 50 ml/min) and long-term safety data has not been evaluated for mild renal impairment (creatinine clearance 50-80 ml/min).
Danish: Der er begrænsede data om sikkerhed og virkning af tenofovirdisoproxil hos voksne patienter med moderat eller svært nedsat nyrefunktion (kreatininclearance < 50 ml/min), og langtidssikkerhedsdata er ikke blevet evalueret for let nedsat nyrefunktion (kreatininclearance 50-80 ml/min).
English: • If it is less than 12 hours after it is usually taken, they should take it as soon as they can, and then take their next dose at its regular time.
Danish: • Hvis det er mindre end 12 timer efter, dosis normalt tages, skal De tage den så hurtigt som muligt og derefter tage den næste dosis på det normale tidspunkt.
English: Table 10: Mean (± SD) tenofovir pharmacokinetic parameters by age groups for paediatric patients
Danish: Tabel 10: Tenofovirs gennemsnitlige (± SD) farmakokinetiske parametre efter aldersgruppe for pædiatriske patienter
English: Serology (%) HBeAg loss/ seroconversion n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
Danish: Serologi (%) Tab af HBeAg/serokonversion n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
English: Viread 33 mg/g granules are only suitable for:
Danish: Viread 33 mg/g granulat er kun egnet til:
English: HBsAg loss/seroconversion
Danish: Tab af HBsAg/serokonversion
English: • If your child has taken Viread during their pregnancy, your child's doctor may request regular blood tests and other diagnostic tests to monitor the development of the baby.
Danish: • Hvis Deres barn har taget Viread under barnets graviditet, kan Deres barns læge anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge babyens udvikling.
English: • If you are an adult and have problems with your kidneys, your doctor may advise you to reduce your daily dose of the granules.
Danish: • Hvis De er voksen og har problemer med Deres nyrer, kan Deres læge råde Dem til at reducere Deres daglige dosis af granulatet.
English: Serum ALT should be persistently elevated for at least 6 months prior to treatment of paediatric patients with compensated liver disease due to HBeAg positive chronic hepatitis B; and for at least 12 months in patients with HBeAg negative disease.
Danish: Serum-ALAT skal være vedvarende forhøjet i mindst 6 måneder forud for behandling af pædiatriske patienter med kompenseret leversygdom, der skyldes HBeAg-positiv kronisk hepatitis B, og i mindst 12 måneder hos patienter med HBeAg-negativ sygdom.
English: Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Danish: Leverfunktionen bør monitoreres i regelmæssige intervaller, både med klinisk kontrol og laboratoriekontroller, i mindst 6 måneder efter seponering af hepatitis B behandlingen.
English: Complete response (%)
Danish: Komplet respons (%)a
English: Viread 33 mg/g granules are not suitable for the following groups:
Danish: Viread 33 mg/g granulat er ikke egnet til følgende grupper:
English: In both of these studies tenofovir disoproxil was significantly superior to adefovir dipivoxil for the primary efficacy endpoint of complete response (defined as HBV DNA levels < 400 copies/ml and Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis).
Danish: I begge disse studier var tenofovirdisoproxil signifikant bedre end adefovirdipivoxil med hensyn til det primære virkningsendepunkt, som var komplet respons (defineret som HBV-dna-niveauer < 400 kopier/ml og en forbedring af Knodells nekroinflammatoriske score på mindst 2 point uden forværring af Knodells fibrosescore).
English: If your child is pregnant or breast-feeding, or they think they may be pregnant, ask your child's doctor or pharmacist for advice before they take this medicine.
Danish: Hvis Deres barn er gravid eller ammer, har mistanke om, at hun er gravid, skal De spørge Deres barns læge eller apotekspersonalet til råds, før De giver dette lægemiddel.
English: Refer to section 2 “Viread contains lactose”.
Danish: 2 „Viread indeholder laktose“.
English: It is recommended that renal function (creatinine clearance and serum phosphate) is assessed in all patients prior to initiating therapy with tenofovir disoproxil and that it is also monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors.
Danish: Det anbefales, at man bedømmer nyrefunktionen (kreatininclearance og serumphosphat) hos alle patienter forud for initiering af behandlingen med tenofovirdisoproxil og den skal monitoreres efter to til fire ugers behandling, efter tre måneders behandling og derefter hver tredje til sjette måned hos patienter uden renale risikofaktorer.
English: Haemodialysis patients: 16.5 mg (0.5 scoop) tenofovir disoproxil 33 mg/g granules may be administered following completion of each 4-hour haemodialysis session.
Danish: Hæmodialyse-patienter: 16,5 mg (0,5 måleske) tenofovirdisoproxil 33 mg/g granulat kan administreres efter afslutning af hver 4-timers hæmodialyse-session.
English: hepatic steatosis, hepatitis Skin and subcutaneous tissue disorders: Very common: rash Rare:
Danish: steatosis hepatis, hepatitis Hud og subkutane væv: Meget almindelig: udslæt Sjælden:
English: Renal function should be closely monitored (see section
Danish: Nyrefunktionen skal monitoreres tæt (se pkt.
English: One tenofovir disoproxil treated subject and no stavudine or zidovudine treated subjects experienced significant (> 4%) lumbar spine BMD loss at week 48.
Danish: Én patient behandlet med tenofovirdisoproxil og ingen patienter behandlet med stavudin eller zidovudin havde signifikant (> 4%) BMD-tab i columna lumbalis ved uge 48.
English: The effects of tenofovir disoproxil-associated changes in BMD on long-term bone health and future fracture risk are currently unknown (see section 5.1).
Danish: Virkningerne af ændringer i BMD associeret med tenofovirdisoproxil på knoglesundheden på længere sigt og fremtidig frakturrisiko kendes ikke på nuværende tidspunkt (se pkt.
English: Use of tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product (e.g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2).
Danish: Samtidig administration og risiko for nyretoksicitet Brug af tenofovirdisoproxil bør undgås med samtidig eller nylig brug af et nefrotoksisk lægemiddel (f.eks. aminoglykosider, amphotericin B, foscarnet, ganciclovir, pentamidin, vancomycin, cidofovir eller interleukin-2).
English: The mean rate of lumbar spine bone gain at week 48 was similar between the tenofovir disoproxil treatment group and the stavudine or zidovudine treatment group.
Danish: Den gennemsnitlige hastighed for knogleøgning i columna lumbalis ved uge 48 var sammenlignelig mellem behandlingsgruppen med tenofovirdisoproxil og behandlingsgruppen med stavudin eller zidovudin.
English: Total dose (mg) tenofovir disoproxil
Danish: Samlet dosis (mg) tenofovirdisoproxil
English: The recommended dose of Viread for the treatment of HIV or for the treatment of chronic hepatitis B is 245 mg (one tablet) once daily taken orally with food.
Danish: Den anbefalede dosis af Viread til behandling af hiv eller til behandling af kronisk hepatitis B er 245 mg (én tablet) en gang dagligt taget oralt sammen med mad.
English: Look out for signs of inflammation or infection soon after your child starts taking Viread.
Danish: Hold øje med tegn på betændelse eller infektion i tiden lige efter, Deres barn begynder at tage Viread.
English: (4 subjects)
Danish: (4 patienter)
English: Co-administration of Viread and didanosine is not recommended as this may result in an increased risk of adverse reactions (see section 4.5).
Danish: Samtidig administration af Viread og didanosin anbefales ikke, da det kan øge risikoen for bivirkninger (se pkt.
English: b Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis.
Danish: b Forbedring af Knodells nekroinflammatoriske score på mindst 2 point uden forværring af Knodells fibrosescore.
English: Tenofovir and tenofovir disoproxil are not metabolised by liver enzymes.
Danish: Tenofovir og tenofovirdisoproxil metaboliseres ikke af leverenzymer.
English: Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0
Danish: Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0
English: Mitochondrial dysfunction following exposure in utero Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Danish: Mitokondriel dysfunktion efter eksponering in utero Nukleosid-/nukleotid-analoger kan påvirke mitokondriefunktionen i varierende grad, dette er mest udtalt for stavudin, didanosin og zidovudin.
English: When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/ml at week 48.
Danish: Når manglende data blev ekskluderet, havde 91% af patienterne i behandlingsgruppen med tenofovirdisoproxil og 94% af patienterne i behandlingsgruppen med stavudin eller zidovudin hiv-1 RNA-koncentrationer på < 400 kopier/ml ved uge 48.