natgillin/translations-raw huggingface dataset:
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.
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.
Se Produktresuméet for disse lægemidler.
Please refer to the Summaries of Product Characteristics for these medicinal products.
Granulatet leveres i en beholder, der indeholder 60 g granulat og er pakket med en måleske.
The granules are supplied in a bottle containing 60 g of granules and are packaged with a dosing scoop.
I kliniske studier med HBV-inficerede patienter, var den hyppigst forekommende bivirkning med tenofovirdisoproxil kvalme (5,4%).
In clinical trials of HBV infected patients, the most frequently occurring adverse reaction to tenofovir disoproxil was nausea (5.4%).
diarré, opkastning, kvalme
diarrhoea, vomiting, nausea
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).
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).
Tenofovirdisoproxils sikkerhed og virkning hos hiv 1-inficerede børn eller børn med kronisk hepatitis B under 2 år er ikke klarlagt.
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.
Der foreligger ingen data, hvorpå der kan laves en dosisanbefaling til patienter over 65 år (se pkt.
No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 4.4).
Meget almindelig: diarré, opkastning, kvalme Almindelig:
Very common: diarrhoea, vomiting, nausea Common:
Mens De tager Viread, kan De stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion.
While taking Viread you may still develop infections or other illnesses associated with HIV infection.
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.
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.
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.
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.
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.
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).
Ca. 1% af de tenofovirdisoproxil-behandlede voksne patienter ophørte med behandlingen på grund af gastrointestinale symptomer.
Approximately 1% of tenofovir disoproxil-treated adult patients discontinued treatment due to the gastrointestinal events.
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.
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.
Disse farmakokinetiske modelleringsdata er ikke blevet bekræftet i kliniske studier.
These pharmacokinetic modelling data have not been confirmed in clinical studies.
Virkningsmekanisme og farmakodynamisk virkning Tenofovirdisoproxilfumarat er fumaratsaltet af et prodrug af tenofovirdisoproxil.
Mechanism of action and pharmacodynamic effects Tenofovir disoproxil fumarate is the fumarate salt of the prodrug tenofovir disoproxil.
245 mg filmovertrukket tablet 12 til < 18 år (n = 8)
245 mg film-coated tablet 12 to < 18 years (n = 8)
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.
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.
• Hiv pædiatrisk uddannelsesbrochure • HBV pædiatrisk uddannelsesbrochure
• HIV paediatric educational brochure
• Hvis De er en kvinde med hiv eller HBV, må De ikke amme for at undgå at smitte barnet via mælken.
• If you are a woman with HIV or HBV do not breast-feed, to avoid passing the virus to the baby in breast milk.
- Lægen har ordineret dette lægemiddel til Deres barn personligt.
- This medicine has been prescribed for your child only.
• Deres barn må ikke tage Viread under graviditeten, medmindre De specifikt har drøftet dette med Deres barns læge.
• Your child must not take Viread during pregnancy unless specifically discussed with your child's doctor.
Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Tyskland eller
Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Germany or
 Hvis dette gælder for Deres barn, skal De omgående fortælle Deres barns læge det og lade være med at give Viread.
 If this applies to your child, tell their doctor immediately and don't give Viread.
• At Viread ikke anbefales til pædiatriske patienter med nedsat nyrefunktion
• That Viread is not recommended for use in paediatric patients with renal impairment
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.
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.
90 (3 tabletbeholdere med 30) tabletter.
90 (3 bottles of 30) tablets.
Hvis Viread bruges samtidig med nefrotoksiske lægemidler, skal nyrefunktionen nøje monitoreres i henhold til det anbefalede skema.
If Viread is used with nephrotoxic medicinal products, renal function should be closely monitored according to the recommended schedule
Viread granulat må ikke blandes med væsker.
Viread granules must not be mixed with liquids.
Viread bør ikke gives til unge med eksisterende nyreproblemer.
Viread should not be given to adolescents with existing kidney problems.
Patienter med dekompenseret leversygdom: Sikkerhedsprofilen for tenofovirdisoproxil hos patienter med dekompenseret leversygdom blev vurderet i et dobbeltblindt, aktivt kontrolleret studie
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
Ophør med Viread kan nedsætte virkningen af den behandling, som Deres læge har anbefalet.
Stopping treatment with Viread may reduce the effectiveness of the treatment recommended by your doctor.
Alvorlige bivirkninger: Kontakt Deres barns læge omgående
Possible serious side effects: tell your child's doctor immediately
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.
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.
Svært nedsat nyrefunktion: 245 mg tenofovirdisoproxil kan administreres hver 72.-96. time (dosering to gange ugentlig).
Severe renal impairment: 245 mg tenofovir disoproxil may be administered every 72-96 hours (dosing twice a week).
Deres barns læge vil nøje tage stilling til, om det er nødvendigt at behandle Deres barn med kombinationer af tenofovir og didanosin.
Your child's doctor will carefully consider whether to treat your child with combinations of tenofovir and didanosine.
Hvis Deres barn har glemt en dosis, skal De finde ud af, hvor lang tid der er gået, siden barnet skulle have taget den.
If your child misses a dose, work out how long since they should have taken it.
Tolerabilitetssvigt (permanent seponering af studiemedicin på grund af en bivirkning, der opstod under behandlingen) n (%)a
Tolerability failure (permanent discontinuation of study drug due to a treatment emergent AE) n (%)a
Histologisk respons (%)b
Histological responsea,b (%)
31 ud af de 32 nukleos(t)id-erfarne patienter havde tidligere erfaring med lamivudin.
Thirty-one of the 32 nucleos(t)ideexperienced patients had prior lamivudine experience.
Tenofovirdiphosphat hæmmer hiv 1-reversetranskriptase og HBV-polymerase ved direkte bindingskonkurrence med det naturlige deoxyribonukleotidsubstrat og - efter indføjelse i dna - ved dna-kædeblokering.
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.
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.
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.
Viread kan have indvirkning på Deres nyrer under behandlingen.
Viread may affect your kidneys during treatment.
Tal med Deres barns læge om, hvilke forholdsregler der er nødvendige for at undgå at smitte andre personer.
Discuss with your child's doctor the precautions needed to avoid infecting other people.
Tenofovirdisoproxil reducerede imidlertid afkommets levedygtighed og vægt i peri-postnatale toksicitetsstudier ved doser, der var toksiske for moderen.
However, tenofovir disoproxil reduced the viability index and weight of pups in peripostnatal toxicity studies at maternally toxic doses.
• fald i phosphat i blodet
• decreases in phosphate in the blood
Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Tyskland
Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Germany
• Hvis De har taget Viread under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
• 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.
Viread granulat indeholder mannitol, der kan have en let afførende virkning.
Viread granules contain mannitol which may have a mild laxative effect.
Det bør også overvejes at seponere behandlingen med Viread i tilfælde af progressiv forværring af nyrefunktionen, når der ikke er identificeret andre årsager.
Interrupting treatment with Viread should also be considered in case of progressive decline of renal function when no other cause has been identified.
Ved uge 48 havde 6 unge i tenofovirdisoproxilgruppen og én ung i placebogruppen signifikant tab i BMD i columna lumbalis (defineret som > 4% tab).
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).
Viread skal tages oralt en gang dagligt sammen med mad.
Viread should be taken once daily, orally with food.
* 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.
* 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.
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.
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.
Viread kan have indvirkning på Deres barns nyrer under behandlingen.
Viread may affect your child's kidneys during treatment.
• At der er en øget risiko for nyresygdom hos hiv- og HBV-inficerede patienter forbundet med tenofovirdisoproxilfumarat-indeholdende præparater, såsom Viread
• 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
Kontakt Deres barns læge eller den nærmeste skadestue for at få råd.
Contact your child's doctor or nearest emergency department for advice.
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).
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).
• Tal med Deres læge, før De holder op med at tage Viread, uanset årsagen, især hvis De oplever bivirkninger eller har en anden sygdom.
• 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.
Ophør med Viread kan nedsætte virkningen af den behandling, som Deres barns læge har anbefalet.
Stopping treatment with Viread may reduce the effectiveness of the treatment recommended by your child's doctor.
De kan også smitte med hiv og HBV, så det er vigtigt at tage forholdsregler for at undgå at smitte andre.
You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.
Deres barn kan også smitte med hiv eller HBV, så det er vigtigt at tage forholdsregler for at undgå at smitte andre.
Your child can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.
• nedbrydning af muskelvæv, smerter eller svaghed i musklerne Prøver kan også vise:
• breakdown of muscle, muscle pain or weakness Tests may also show:
8 patienter (2%) behandlet med 245 mg tenofovirdisoproxil udviklede K65R mutationen inden for de første 48 uger.
Eight (2%) tenofovir disoproxil 245 mg treated patients developed the K65R mutation within the first 48 weeks.
Disse justeringer af doseringsintervallet er ikke blevet bekræftet i kliniske studier.
These dose adjustments have not been confirmed in clinical studies.
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.
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).
Hos patienter med moderat eller svært nedsat nyrefunktion (kreatininclearance < 50 ml/min) skal den daglige dosis justeres og nyrefunktionen monitoreres tæt (se pkt.
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).
Der kræves en spiseskefuld (15 ml) blød mad pr. strøget måleske granulat.
One tablespoon (15 ml) of soft food per one level scoop of granules is required.
• 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.
• 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.
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.
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.
Hvis De er voksen, kan Deres læge måske råde Dem til at reducere Deres daglige dosis af granulatet.
If you are an adult, your doctor may advise you to reduce your daily dose of the granules.
• Det er meget vigtigt at fortælle Deres barns læge det, hvis Deres barn tager anden medicin, som kan skade barnets nyrer.
• It is very important to tell your child's doctor if your child is taking other medicines that may damage their kidneys.
Mens Deres barn tager Viread, kan Deres barn stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion.
While taking Viread your child may still develop infections or other illnesses associated with HIV infection.
• Kontakt Deres barns læge, før Deres barn igen begynder at tage Viread tabletter.
• Contact your child's doctor before your child restarts taking Viread tablets.
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.
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.
• 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.
• 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.
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.
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.
• 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.
• 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.
Den gennemsnitlige hastighed for stigning i BMD var mindre i tenofovirdisoproxil-gruppen sammenlignet med placebogruppen.
The mean rate of BMD gain was less in the tenofovir disoproxil group compared to the placebo group.
Viread granulat indeholder mannitol
Viread granules contain mannitol
Den anbefalede dosis er 6,5 mg/kg kropsvægt tenofovirdisoproxil en gang dagligt taget sammen med mad.
The recommended dose is 6.5 mg of tenofovir disoproxil per kilogram of body weight once daily taken with food.
Viread granulat skal afmåles med den leverede måleske.
Viread granules should be measured with the supplied dosing scoop.
• voksne • unge i alderen 12 til under 18 år, som allerede er blevet behandlet med anden hiv-medicin,
• adolescents aged 12 to less than 18 years who have already been treated with other HIV
Anvendes med den leverede måleske.
Use with the supplied dosing scoop.
6,5 mg/kg granulat 2 til < 12 år (n = 23)
6.5 mg/kg granules 2 to < 12 years (n = 23)
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.
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.
Alle bivirkninger vises i tabel 3.
All adverse reactions are presented in Table 3.
Der er udført et farmakokinetisk studie hos voksne patienter uden hiv-infektion med forskellige grader af nedsat leverfunktion.
A pharmacokinetic study has been performed in non-HIV infected adult patients with various degrees of hepatic impairment.
Voksne og unge i alderen 12 til < 18 år, der vejer ≥ 35 kg:
Adults and adolescents aged 12 to < 18 years and weighing ≥ 35 kg:
• Hvis De er allergisk over for tenofovir, tenofovirdisoproxil eller et af de øvrige indholdsstoffer i Viread angivet i punkt 6.
• If you are allergic to tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine listed in section 6.
• Hvis det er mere end 12 timer siden Deres barn skulle have taget den, skal Deres barn ikke tage den glemte dosis.
• If it is more than 12 hours since your child should have taken it, forget about the missed dose.
- Aktivt stof: tenofovir.
- The active substance is tenofovir.
En formulering af tenofovirdisoproxil som granulat fås til patienter, der har problemer med at synke filmovertrukne tabletter.
A granules formulation of tenofovir disoproxil is available for patients having difficulty in swallowing film-coated tablets.
Påvirkning af nyrer og knogler hos den voksne population Påvirkning af nyrer
Renal and bone effects in adult population
Viread 245 mg filmovertrukne tabletter er indiceret i kombination med andre antiretrovirale lægemidler til behandling af hiv 1-inficerede voksne.
Viread 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.
• ændringer i Deres barns urin og rygsmerter på grund af nyreproblemer, inklusive nyresvigt
• changes to your child's urine and back pain caused by kidney problems, including kidney failure
• problemer med lever
• liver problems
• Hvis Deres barn er allergisk over for tenofovir, tenofovirdisoproxil eller et af de øvrige indholdsstoffer i Viread angivet i punkt 6.
• If your child is allergic to tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine listed in section 6.
Yderligere oplysninger om Viread findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu