FrancophonIA/ELRC3.0 huggingface dataset:
English: No significant pharmacokinetic alteration has been observed in these patients (see section 5.2).
Danish: Der blev ikke observeret nogen signifikant farmakokinetisk ændring hos disse patienter (se pkt.
English: • That use of Viread should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Danish: • At brugen af Viread bør undgås med samtidig eller nylig brug af nefrotoksiske lægemidler.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på beholderen og pakningen efter (Exp).
English: Viread can cause dizziness.
Danish: Viread kan forårsage svimmelhed.
English: Viread granules should be measured with the supplied dosing scoop (see Figure A):
Danish: Viread granulat skal afmåles med den medfølgende måleske (se figur A):
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: Limited clinical data are available at the 6.5 mg/kg dose of the granules.
Danish: Der er begrænsede kliniske data om 6,5 mg/kg dosis af granulat.
English: Alternative treatment regimens should be considered for patients with osteoporosis that are at a high risk for fractures.
Danish: Alternative behandlingsregimer bør overvejes for patienter med osteoporose med høj risiko for frakturer.
English: In HIV Viread should always be used combined with other medicines to treat HIV infection.
Danish: Viread bør altid anvendes i kombination med anden medicin for at behandle en hiv-infektion.
English: c Median change from baseline HBV DNA merely reflects the difference between baseline HBV DNA and the limit of detection (LOD) of the assay.
Danish: c Median ændring fra baseline HBV-dna reflekterer blot forskellen mellem baseline HBV-dna og analysens detektionsgrænse (Limit of detection - LOD).
English: Among them, 3 patients experienced a clinically meaningful decline in estimated GFR which improved after discontinuation of tenofovir disoproxil.
Danish: Blandt dem oplevede 3 patienter en klinisk betydningsfuld reduktion i estimeret GFR, som bedredes efter seponering af tenofovirdisoproxil.
English: They are only suitable for:
Danish: De er kun egnede til:
English: However, in exceptional circumstances Viread 245 mg film-coated tablets can be administered following disintegration of the tablet in at least 100 ml of water, orange juice or grape juice.
Danish: I særlige tilfælde kan Viread 245 mg filmovertrukne tabletter imidlertid administreres, efter tabletten er blevet opløst i mindst 100 ml vand, appelsinjuice eller druesaft.
English: Tenofovir disoproxil must be taken with food, as food enhances the bioavailability of tenofovir (see section 5.2).
Danish: Tenofovirdisoproxil skal tages sammen med mad, da mad forbedrer tenofovirs biotilgængelighed (se pkt.
English: The active substance tenofovir disoproxil and its main transformation products are persistent in the environment.
Danish: Miljørisikovurdering Det aktive stof tenofovirdisoproxil og dets primære omdannelsesprodukter er persistente i miljøet.
English: • That Viread may cause a reduction in BMD and the effects of Viread associated changes in BMD on long term bone health and future fracture risk are currently unknown in paediatric patients
Danish: • At Viread kan forårsage en reduktion i BMD og virkningerne af ændringer i BMD associeret med Viread på knoglesundheden på længere sigt og fremtidig frakturrisiko ikke kendes på nuværende tidspunkt hos pædiatriske patienter
English: Your child's doctor will test for these changes.
Danish: Deres barns læge vil holde øje med disse ændringer.
English: If you are older than this and are prescribed Viread, your doctor will monitor you carefully.
Danish: Hvis De er over 65 år og får ordineret Viread, vil Deres læge overvåge Dem nøje.
English: Simulations suggest that the prolonged dose interval using Viread 245 mg film-coated tablets is not optimal and could result in increased toxicity and possibly inadequate response.
Danish: Simuleringer antyder, at 245 mg filmovertrukne tabletter med forlænget doseringsinterval ikke er optimalt, og at det kan resultere i øget toksicitet og muligt inadækvat respons.
English: Viread should not be given to children with existing kidney problems.
Danish: Viread bør ikke gives til børn med eksisterende nyreproblemer.
English: 2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical trials or the tenofovir disoproxil expanded access program.
Danish: 2 Denne bivirkning blev identificeret under sikkerhedsovervågningen efter markedsføring, men blev ikke observeret i randomiserede, kontrollerede, kliniske studier eller i programmet for forlænget adgang til tenofovirdisoproxil.
English:  If this applies to you, tell your doctor immediately and don't take Viread.
Danish:  Hvis dette gælder for Dem, skal De omgående fortælle Deres læge det og lade være med at tage Viread.
English: Children aged 2 to < 12 years:
Danish: Børn i alderen 2 til < 12 år:
English: • Use the flat edge of clean knife to make the granules even with the top of the scoop (see Figure B).
Danish: • Brug den flade kant af en ren kniv til at fjerne overskydende granulat fra måleskeens top (se figur B).
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Viread.
Danish: Nogle patienter har symptomer på, eller deres blodprøver viser, at deres hepatitis er blevet forværret efter ophør med behandlingen med Viread.
English: Tenofovir disoproxil at a concentration of 100 µmol/l had no effect on any of the CYP450 isoforms, except CYP1A1/2, where a small (6%) but statistically significant reduction in metabolism of CYP1A1/2 substrate was observed.
Danish: Tenofovirdisoproxil i en koncentration på 100 µmol/l havde ingen effekt på nogen af CYP450-isoformerne undtagen CYP1A1/2, hvor der sås en lille (6%), men statistisk signifikant reduktion i metaboliseringen af CYP1A1/2-substrat.
English: Viread does not reduce the risk of passing on HBV to others through sexual contact or blood contamination.
Danish: Viread nedsætter ikke risikoen for at smitte andre med HBV ved seksuel kontakt eller med inficeret blod.
English: Table 1: Dosing for children aged 2 to < 12 years
Danish: Tabel 1: Dosering for børn i alderen 2 til < 12 på
English: If your child feels dizzy while taking Viread, they must not drive or ride a bicycle and must not use any tools or machines.
Danish: Hvis Deres barn bliver svimmel, når barnet tager Viread, må barnet ikke føre motorkøretøj eller cykle og arbejde med værktøj eller maskiner.
English: • You must not take Viread during pregnancy unless specifically discussed with your doctor.
Danish: • De må ikke tage Viread under graviditeten, medmindre De specifikt har drøftet dette med Deres læge.
English: This active substance is an antiretroviral or antiviral medicine which is used to treat HIV or HBV infection or both.
Danish: Dette aktive stof er en form for medicin, der kaldes antiretroviral eller antiviral medicin, som anvendes til behandling af enten hiv- eller HBV-infektion eller begge dele.
English: You do not have to have HIV to be treated with Viread for HBV.
Danish: De behøver ikke nødvendigvis have hiv for at blive behandlet med Viread for HBV.
English: Viread has not been studied in patients over 65 years of age.
Danish: Viread er ikke undersøgt hos patienter over 65 år.
English: The choice of Viread to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients.
Danish: Valget af Viread som behandlingsform til tidligere antiretroviral-behandlede patienter med hiv 1-infektion skal baseres på individuel testning af patienternes virusresistens og/eller deres behandlingsanamnese.
English: Your child does not have to have HIV to be treated with Viread for HBV.
Danish: Deres barn behøver ikke at have hiv for at blive behandlet med Viread for HBV.
English: If this is unavoidable, your child's doctor will monitor your child's kidney function once a week.
Danish: Hvis dette ikke kan undgås, vil Deres barns læge overvåge Deres barns nyrefunktion en gang om ugen.
English: The oral bioavailability of tenofovir from tenofovir disoproxil in fasted patients was approximately 25%.
Danish: Den orale biotilgængelighed af tenofovir fra tenofovirdisoproxil var ca. 25% hos fastende patienter.
English: Effects on drug levels Mean percent change in AUC,
Danish: Virkning på medicinindhold Gennemsnitlig ændring (%) i AUC,
English: Please refer to the Summaries of Product Characteristics for Viread 33 mg/g granules and Viread 123 mg, 163 mg and 204 mg film-coated tablets.
Danish: Se Produktresuméer for Viread 33 mg/g granulat og Viread 123 mg, 163 mg og 204 mg filmovertrukne tabletter.
English: In studies GS-US-174-0102 and GS-US-174-0103, 77% and 61% of patients continued in the study through to 384 weeks, respectively.
Danish: I studierne GS-US-174-0102 og GS-US-174-0103 fortsatte henholdsvis 77% og 61% af patienterne i studiet til og med uge 384.
English: Please refer to the Summaries of Product Characteristics for these medicinal products.
Danish: Se Produktresuméet for disse lægemidler.
English: The granules are supplied in a bottle containing 60 g of granules and are packaged with a dosing scoop.
Danish: Granulatet leveres i en beholder, der indeholder 60 g granulat og er pakket med en måleske.
English: In clinical trials of HBV infected patients, the most frequently occurring adverse reaction to tenofovir disoproxil was nausea (5.4%).
Danish: I kliniske studier med HBV-inficerede patienter, var den hyppigst forekommende bivirkning med tenofovirdisoproxil kvalme (5,4%).
English: diarrhoea, vomiting, nausea
Danish: diarré, opkastning, kvalme
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil in randomised controlled clinical trials and the expanded access program (n = 7,319).
Danish: Hyppighedskategorien ‘ikke almindelig' blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter eksponeret for tenofovirdisoproxil i randomiserede, kontrollerede, kliniske studier og i programmet for forlænget adgang (n=7.319).
English: The safety and efficacy of tenofovir disoproxil in HIV-1 infected children or children with chronic hepatitis B under 2 years of age have not been established.
Danish: Tenofovirdisoproxils sikkerhed og virkning hos hiv 1-inficerede børn eller børn med kronisk hepatitis B under 2 år er ikke klarlagt.
English: No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 4.4).
Danish: Der foreligger ingen data, hvorpå der kan laves en dosisanbefaling til patienter over 65 år (se pkt.
English: Very common: diarrhoea, vomiting, nausea Common:
Danish: Meget almindelig: diarré, opkastning, kvalme Almindelig:
English: While taking Viread you may still develop infections or other illnesses associated with HIV infection.
Danish: Mens De tager Viread, kan De stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion.
English: Baseline genotypic analysis of HIV isolates from 253 patients revealed that 94% of patients had HIV-1 resistance mutations associated with nucleoside reverse transcriptase inhibitors, 58% had mutations associated with protease inhibitors and 48% had mutations associated with non-nucleoside reverse transcriptase inhibitors.
Danish: Genotypeanalyse ved baseline af hiv-isolater fra 253 patienter afslørede, at 94% af patienterne havde hiv 1-resistensmutationer i forbindelse med nukleosid reverse transkriptasehæmmere, 58% havde mutationer i forbindelse med proteasehæmmere og 48% havde mutationer i forbindelse med non-nukleosid reverse transkriptasehæmmere.
English: Of the 94 patients with cirrhosis at baseline (Ishak fibrosis score: 5 - 6), 26% (24) experienced no change in Ishak fibrosis score and 72% (68) experienced regression of cirrhosis by week 240 with a reduction in Ishak fibrosis score of at least 2 points.
Danish: Ud af 94 patienter med cirrose ved baseline (Ishaks fibrosescore: 5 - 6) oplevede 26% (24) ingen ændring i Ishaks fibrosescore, og 72% (68) oplevede regression af cirrose ved uge 240 med en reduktion i Ishaks fibrosescore på mindst 2 point.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Viread in one or more subsets of the paediatric population in HIV and chronic hepatitis B (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Viread i en eller flere undergrupper af den pædiatriske population med hiv og kronisk hepatitis B (se pkt.
English: Approximately 1% of tenofovir disoproxil-treated adult patients discontinued treatment due to the gastrointestinal events.
Danish: Ca. 1% af de tenofovirdisoproxil-behandlede voksne patienter ophørte med behandlingen på grund af gastrointestinale symptomer.
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 vist en gavnlig effekt ved tenofovirdisoproxil sammenlignet med placebo baseret på plasma-hiv 1-rnaniveauer ved uge 24.
English: These pharmacokinetic modelling data have not been confirmed in clinical studies.
Danish: Disse farmakokinetiske modelleringsdata er ikke blevet bekræftet i kliniske studier.
English: Mechanism of action and pharmacodynamic effects Tenofovir disoproxil fumarate is the fumarate salt of the prodrug tenofovir disoproxil.
Danish: Virkningsmekanisme og farmakodynamisk virkning Tenofovirdisoproxilfumarat er fumaratsaltet af et prodrug af tenofovirdisoproxil.
English: 245 mg film-coated tablet 12 to < 18 years (n = 8)
Danish: 245 mg filmovertrukket tablet 12 til < 18 år (n = 8)
English: There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ethinyl oestradiol.
Danish: Der var ingen klinisk signifikante farmakokinetiske interaktioner, når tenofovirdisoproxil blev administreret sammen med emtricitabin, lamivudin, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir-boostet), methadon, ribavirin, rifampicin, tacrolimus eller hormonantikonceptionsmidlet norgestimat/ethinylestradiol.
English: • HIV paediatric educational brochure
Danish: • Hiv pædiatrisk uddannelsesbrochure • HBV pædiatrisk uddannelsesbrochure
English: • If you are a woman with HIV or HBV do not breast-feed, to avoid passing the virus to the baby in breast milk.
Danish: • Hvis De er en kvinde med hiv eller HBV, må De ikke amme for at undgå at smitte barnet via mælken.
English: - This medicine has been prescribed for your child only.
Danish: - Lægen har ordineret dette lægemiddel til Deres barn personligt.
English: • Your child must not take Viread during pregnancy unless specifically discussed with your child's doctor.
Danish: • Deres barn må ikke tage Viread under graviditeten, medmindre De specifikt har drøftet dette med Deres barns læge.
English: Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Germany or
Danish: Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Tyskland eller
English:  If this applies to your child, tell their doctor immediately and don't give Viread.
Danish:  Hvis dette gælder for Deres barn, skal De omgående fortælle Deres barns læge det og lade være med at give Viread.
English: • That Viread is not recommended for use in paediatric patients with renal impairment
Danish: • At Viread ikke anbefales til pædiatriske patienter med nedsat nyrefunktion
English: HIV antiviral activity in vitro: The concentration of tenofovir required for 50% inhibition (EC50) of the wild-type laboratory strain HIV-1IIIB is 1-6 µmol/l in lymphoid cell lines and 1.1 µmol/l against primary HIV-1 subtype B isolates in PBMCs.
Danish: Hiv-antiviral aktivitet in vitro: Den koncentration af tenofovir, der kræves til 50% hæmning (EC50) af laboratorie-vildtypestammen hiv 1IIIB, er 1-6 µmol/l ved lymfoide cellelinier og 1,1 µmol/l mod primære hiv 1 subtype B isolater i PBMC'er.
English: 90 (3 bottles of 30) tablets.
Danish: 90 (3 tabletbeholdere med 30) tabletter.
English: If Viread is used with nephrotoxic medicinal products, renal function should be closely monitored according to the recommended schedule
Danish: Hvis Viread bruges samtidig med nefrotoksiske lægemidler, skal nyrefunktionen nøje monitoreres i henhold til det anbefalede skema.
English: Viread granules must not be mixed with liquids.
Danish: Viread granulat må ikke blandes med væsker.
English: Viread should not be given to adolescents with existing kidney problems.
Danish: Viread bør ikke gives til unge med eksisterende nyreproblemer.
English: Patients with decompensated liver disease: The safety profile of tenofovir disoproxil in patients with decompensated liver disease was assessed in a double-blind active controlled study
Danish: Patienter med dekompenseret leversygdom: Sikkerhedsprofilen for tenofovirdisoproxil hos patienter med dekompenseret leversygdom blev vurderet i et dobbeltblindt, aktivt kontrolleret studie
English: Stopping treatment with Viread may reduce the effectiveness of the treatment recommended by your doctor.
Danish: Ophør med Viread kan nedsætte virkningen af den behandling, som Deres læge har anbefalet.
English: Possible serious side effects: tell your child's doctor immediately
Danish: Alvorlige bivirkninger: Kontakt Deres barns læge omgående
English: Although these doses are not expected to exactly reproduce the pharmacokinetic profile of tenofovir in patients with normal renal function receiving tenofovir disoproxil 245 mg film-coated tablets, they are considered to represent the best balance of benefit and risk for patients with renal impairment.
Danish: Selvom disse doser ikke forventes at reproducere den farmakokinetiske profil for tenofovir nøjagtigt som for patienter med normal nyrefunktion, der får tenofovirdisoproxil 245 mg filmovertrukne tabletter, anses de for at repræsentere den bedste balance mellem fordele og risici hos patienter med nedsat nyrefunktion.
English: Severe renal impairment: 245 mg tenofovir disoproxil may be administered every 72-96 hours (dosing twice a week).
Danish: Svært nedsat nyrefunktion: 245 mg tenofovirdisoproxil kan administreres hver 72.-96. time (dosering to gange ugentlig).
English: Your child's doctor will carefully consider whether to treat your child with combinations of tenofovir and didanosine.
Danish: Deres barns læge vil nøje tage stilling til, om det er nødvendigt at behandle Deres barn med kombinationer af tenofovir og didanosin.
English: If your child misses a dose, work out how long since they should have taken it.
Danish: Hvis Deres barn har glemt en dosis, skal De finde ud af, hvor lang tid der er gået, siden barnet skulle have taget den.
English: Tolerability failure (permanent discontinuation of study drug due to a treatment emergent AE) n (%)a
Danish: Tolerabilitetssvigt (permanent seponering af studiemedicin på grund af en bivirkning, der opstod under behandlingen) n (%)a
English: Histological responsea,b (%)
Danish: Histologisk respons (%)b
English: Thirty-one of the 32 nucleos(t)ideexperienced patients had prior lamivudine experience.
Danish: 31 ud af de 32 nukleos(t)id-erfarne patienter havde tidligere erfaring med lamivudin.
English: Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.
Danish: Tenofovirdiphosphat hæmmer hiv 1-reversetranskriptase og HBV-polymerase ved direkte bindingskonkurrence med det naturlige deoxyribonukleotidsubstrat og - efter indføjelse i dna - ved dna-kædeblokering.
English: If a patient misses a dose of Viread by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
Danish: Hvis en patient glemmer at tage en dosis Viread i mere end 12 timer, og det næsten er tid til næste dosis, skal patienten ikke tage den manglende dosis, men blot fortsætte med den normale doseringsplan.
English: Viread may affect your kidneys during treatment.
Danish: Viread kan have indvirkning på Deres nyrer under behandlingen.
English: Discuss with your child's doctor the precautions needed to avoid infecting other people.
Danish: Tal med Deres barns læge om, hvilke forholdsregler der er nødvendige for at undgå at smitte andre personer.
English: However, tenofovir disoproxil reduced the viability index and weight of pups in peripostnatal toxicity studies at maternally toxic doses.
Danish: Tenofovirdisoproxil reducerede imidlertid afkommets levedygtighed og vægt i peri-postnatale toksicitetsstudier ved doser, der var toksiske for moderen.
English: • decreases in phosphate in the blood
Danish: • fald i phosphat i blodet
English: Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Germany
Danish: Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Tyskland
English: • If you have taken Viread during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: • Hvis De har taget Viread under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: Viread granules contain mannitol which may have a mild laxative effect.
Danish: Viread granulat indeholder mannitol, der kan have en let afførende virkning.
English: Interrupting treatment with Viread 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 seponere behandlingen med Viread i tilfælde af progressiv forværring af nyrefunktionen, når der ikke er identificeret andre årsager.
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: Ved uge 48 havde 6 unge i tenofovirdisoproxilgruppen og én ung i placebogruppen signifikant tab i BMD i columna lumbalis (defineret som > 4% tab).
English: Viread should be taken once daily, orally with food.
Danish: Viread skal tages oralt en gang dagligt sammen med mad.
English: * p-value versus adefovir dipivoxil < 0.05. a 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: * p-værdi versus adefovirdipivoxil < 0,05. a 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: In studies with nucleoside-naïve patients, on-treatment ALT elevations > 10 times ULN (upper limit of normal) and > 2 times baseline occurred in 2.6% of tenofovir disoproxil-treated patients.
Danish: I studier med nukleosid-naive patienter forekom der efter behandlingsstart stigninger i ALAT > 10 gange ULN (øvre grænse af normalværdien) og > 2 gange baseline hos 2,6% af de tenofovirdisoproxil-behandlede patienter.
English: Viread may affect your child's kidneys during treatment.
Danish: Viread kan have indvirkning på Deres barns nyrer under behandlingen.