natgillin/translations-raw huggingface dataset:
Behandlingens virkning blev hovedsagelig bedømt efter den andel af patienterne, hos hvem hiv- indholdet i blodet var faldet til under 400 eller 50 kopier/ ml og holdt sig under dette niveau indtil 48. behandlingsuge.
The main measure of effectiveness was the proportion of patients whose HIV levels in the blood (viral loads) had fallen to below 400 or 50 copies/ ml and were maintained below these levels until the 48th week of treatment.
Firmaet under - søgte desuden, hvordan den kombinerede tablet blev optaget i kroppen i forhold til de separate præpa - rater.
The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate medicines.
Hvilken fordel viser undersøgelserne, at der er ved Truvada?
What benefit has Truvada shown during the studies?
I kombination med andre antivirale lægemidler nedsatte de aktive stoffer i Truvada hiv- mængden i blodet hos størstedelen af patienterne og var mere effektive end sammenligningslægemidlerne.
Truvada’ s active substances, taken in combination with other antiviral medicines, reduced viral loads in the majority of patients and were more effective than the comparator medicines.
I den første undersøgelse opnåede 84% af de 244 patienter, der fik Truvada, et virusindhold på under 400 kopier/ ml og fastholdt det efter 48 uger, sammenholdt med 73% af de 243, der fik sammenlig - ningslægemidlerne.
In the first study, 84% of the 244 patients taking Truvada achieved and maintained viral loads below 400 copies/ ml by 48 weeks, compared to 73% of the 243 taking the comparator medicines.
I den anden undersøgelse opnåede ca. to tredjedele af patienterne et virusindhold på mindre end 50 kopier/ ml og fastholdt dette efter 48 uger.
Around two thirds of the patients in the second study achieved and maintained viral loads below 50 copies/ ml after 48 weeks.
Kombinationstabletten blev optaget i kroppen på samme måde som de separate lægemidler.
The combination tablet was absorbed in the body in the same way as the separate medicines.
De hyppigste bivirkninger af Truvada (som ses hos flere end 1 ud af 10 patienter) er hypofosfatæmi (for lavt fosfatindhold i blodet), hovedpine, svimmelhed, diarré, opkastning, kvalme og forhøjet ind - hold i blodet af kreatinkinase (et enzym, der findes i musklerne).
The most common side effects with Truvada (seen in more than 1 patient in 10) are hypophosphataemia (low levels of phosphates in the blood), headache, dizziness, diarrhoea, vomiting, nausea (feeling sick) and raised blood levels of creatine kinase (an enzyme found in muscles).
Den fuldstændige liste over de indbe - rettede bivirkninger for Truvada fremgår af indlægssedlen.
For the full list of all side effects reported with Truvada, see the Package Leaflet.
Truvada bør ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for emtricitabin, tenofovir, tenofovir tenofovirdisoproxilfumarat eller andre af indholdsstofferne.
Truvada should not be used in patients who may be hypersensitive (allergic) to emtricitabine, tenofovir, tenofovir disoproxil fumarate or any of the other ingredients.
Som med anden hiv- medicin kan patienter, der får Truvada, få lipodystrofi (ændret fedtfordeling i kroppen), osteonekrose (knoglevævsdød) eller immunreaktiveringssyndrom (infektionslignende symp - tomer, der skyldes, at immunsystemet genvinder sin funktion).
As with other anti-HIV medicines, patients taking Truvada may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Patienter med leverproblemer (herun - der hepatitis B eller C) kan have forhøjet risiko for leverskade, når de får Truvada.
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Truvada.
Endvidere kan nyfødte børn, hvis mødre har fået Truvada under graviditeten, få mitokondriel dysfunk - tion (beskadigelse af de energiproducerende cellebestanddele med blodproblemer til følge).
As with all other NRTIs, Truvada may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Truvada during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells than can cause problems in the blood).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Truvada opvejer risiciene til antiretroviral kombinationsbehandling af hiv- 1- smittede voksne.
The Committee for Medicinal products for Human Use (CHMP) concluded that Truvada’ s benefits are greater than its risks in antiretroviral combination therapy for the treatment of HIV-1 infected adults.
Udvalget konstaterede, at fordelen ved Truvada kun er påvist hos patienter, der ikke tidligere har fået medicin mod hiv, men at den forenklede doseringsplan med en kombinationstablet, der tages én gang dagligt, kan gøre det lette - re for patienterne at overholde behandlingen.
It noted that the benefit of Truvada has only been shown in patients who have not taken HIV treatment before, but that the simplified dosing regimen offered by the combination tablet taken once a day may help patients to stick to their treatment.
Udvalget anbefalede udstedelse af markedsføringstilla - delse for Truvada.
The committee recommended that Truvada be given marketing authorisation.
Andre oplysninger om Truvada:
Other information about Truvada:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Truvada til Gilead Sciences International Limited den 21. februar 2005.
The European Commission granted a marketing authorisation valid throughout the EU for Truvada to Gilead Sciences International Limited on 21 February 2005.
Den fuldstændige EPAR om Truvada findes her.
The full EPAR for Truvada is available here.
Truvada Truvada
Truvada Truvada
200 mg / 245 mg 200 mg / 245 mg
200 mg / 245 mg 200 mg / 245 mg
Filmovertrukket tablett Filmovertrukket tablett
Film-coated tablet Film-coated tablet
Flaske (HDPE) Flaske (HDPE)
Bottle (HDPE) Bottle (HDPE)
30 tabletter 3 x 30 tabletter
30 tablets 3 x 30 tablets
Truvada 200 mg/ 245 mg filmovertrukne tabletter.
Truvada 200 mg/ 245 mg film-coated tablets.
Hver tablet indeholder 80 mg lactosemonohydrat.
Each tablet contains 80 mg lactose monohydrate.
Blå, kapselformede, filmovertrukne tabletter, på den ene side præget med "GILEAD" og på den anden side med "701".
Blue, capsule-shaped, film-coated tablet, debossed on one side with “ GILEAD” and on the other side with “ 701”.
Truvada er en fastdosiskombination af emtricitabin og tenofovirdisoproxilfumarat.
Truvada is a fixed dose combination of emtricitabine and tenofovir disoproxil fumarate.
Det er indiceret i antiretroviral kombinationsbehandling til behandling af HIV- 1- inficerede voksne.
It is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.
5. 1).
The demonstration of the benefit of the combination emtricitabine and tenofovir disoproxil fumarate in antiretroviral therapy is based solely on studies performed in treatment-naïve patients (see section 5.1).
Terapi skal startes af en læge med erfaring i behandlingen af HIV- infektion.
Therapy should be initiated by a physician experienced in the management of HIV infection.
Dosering Voksne:
Posology Adults:
Den anbefalede dosis af Truvada er én tablet, taget peroralt, en gang daglig.
The recommended dose of Truvada is one tablet, taken orally, once daily.
For at optimere tenofovirs absorption anbefales det, at Truvada tages sammen med mad.
In order to optimise the absorption of tenofovir, it is recommended that Truvada should be taken with food.
5. 2).
Even a light meal improves absorption of tenofovir from the combination tablet (see section 5.2).
I tilfælde, hvor det er indiceret at stoppe behandlingen med et af indholdsstofferne i Truvada, eller hvor modifikation af dosis er nødvendig, findes separate præparater med emtricitabin og tenofovirdisoproxilfumarat.
Where discontinuation of therapy with one of the components of Truvada is indicated or where dose modification is necessary, separate preparations of emtricitabine and tenofovir disoproxil fumarate are available.
5. 2).
Truvada is not recommended for use in children below the age of 18 years due to insufficient data on safety and efficacy (see section 5.2).
Der forefindes intet materiale, hvorpå der kan laves en dosisanbefaling til patienter over 65 år.
No data are available on which to make a dose recommendation for patients over the age of 65 years.
Det burde dog ikke være nødvendigt at tilpasse den anbefalede daglige dosis til voksne, medmindre der er tegn på nyreinsufficiens.
However, no adjustment in the recommended daily dose for adults should be required unless there is evidence of renal insufficiency.
Emtricitabin og tenofovir udskilles via nyrerne, og eksponeringen over for emtricitabin og tenofovir øges hos patienter med nyredysfunktion.
Emtricitabine and tenofovir are eliminated by renal excretion and the exposure to emtricitabine and tenofovir increases in patients with renal dysfunction.
Der er begrænsede data om sikkerhed og virkning af Truvada hos patienter med moderat eller svært nedsat nyrefunktion
There are limited data on the safety and efficacy of Truvada in 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
2 (kreatinin- clearance < 50 ml/ min), og langtidssikkerhedsdata er ikke blevet evalueret for let nedsat nyrefunktion (kreatinclearance < 50- 80 ml/ min).
2 (creatinine clearance 50-80 ml/ min).
Truvada bør derfor kun bruges til patienter med nedsat nyrefunktion, hvis de potentielle fordele ved behandlingen anses for at veje tungere end de potentielle risici.
Therefore, in patients with renal impairment Truvada should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Hos patienter med nedsat nyrefunktion kan det være nødvendigt at overvåge nyrefunktionen nøje (se pkt.
Patients with renal impairment may require close monitoring of renal function (see section 4.4).
Det anbefales at justere dosisintervallet hos patienter med en kreatinclearance mellem 30 og 49 ml/ min.
Dose interval adjustments are recommended for patients with creatinine clearance between 30 and 49 ml/ min.
4. 4 og 5. 2).
These dose adjustments have not been confirmed in clinical studies and the clinical response to treatment should be closely monitored in these patients (see sections 4.4 and 5.2).
Let nedsat nyrefunktion (kreatinin- clearance 50- 80 ml/ min):
Mild renal impairment (creatinine clearance 50-80 ml/ min):
4. 4).
Limited data from clinical studies support once daily dosing of Truvada in patients with mild renal impairment (see section 4.4).
Moderat nedsat nyrefunktion (kreatinin- clearance 30- 49 ml/ min):
Moderate renal impairment (creatinine clearance 30-49 ml/ min):
4. 4).
Administration of Truvada every 48 hours is recommended, based on modelling of single-dose pharmacokinetic data for emtricitabine and tenofovir disoproxil fumarate in non-HIV infected subjects with varying degrees of renal impairment (see section 4.4). Severe renal impairment (creatinine clearance < 30 ml/ min) and haemodialysis patients:
Truvada anbefales ikke til patienter med svært nedsat nyrefunktion (kreatinin- clearance < 30 ml/ min) eller til patienter, som har behov for hæmodialyse, fordi de passende dosisreduktioner ikke kan opnås med kombinationstabletten.
Truvada is not recommended for patients with severe renal impairment (creatinine clearance < 30 ml/ min) and in patients who require haemodialysis because appropriate dose reductions cannot be achieved with the combination tablet.
Truvadas og emtricitabins farmakokinetik er ikke undersøgt hos patienter med nedsat leverfunktion.
The pharmacokinetics of Truvada and emtricitabine have not been studied in patients with hepatic impairment.
Tenofovirs farmakokinetik er undersøgt hos patienter med nedsat leverfunktion, og hos disse patienter er en dosisjustering af tenofovirdisoproxilfumarat ikke nødvendig.
The pharmacokinetics of tenofovir have been studied in patients with hepatic impairment and no dose adjustment is required for tenofovir disoproxil fumarate in these patients.
4. 4 og 5. 2).
Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for Truvada in patients with hepatic impairment (see sections 4.4 and 5.2).
4. 4).
If Truvada is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Indgivelsesmåde Hvis patienter har problemer med at synke, kan Truvada indgives umiddelbart efter, at tabletten er opløst i cirka 100 ml vand, appelsinjuice eller druesaft.
Method of administration If patients have difficulty in swallowing, Truvada can be disintegrated in approximately 100 ml of water, orange juice or grape juice and taken immediately.
Overfølsomhed over for de aktive stoffer emtricitabin, tenofovir, tenofovirdisoproxilfumarat eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substances emtricitabine, tenofovir, tenofovir disoproxil fumarate or to any of the excipients.
4. 5).
Truvada should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil (as fumarate) or other cytidine analogues, such as lamivudine and zalcitabine (see section 4.5).
Trestofsbehandling med nukleosider:
Triple nucleoside therapy:
Der er rapporteret om høj forekomst af manglende virologisk effekt og om resistensudvikling, begge på et tidligt tidspunkt, når tenofovirdisoproxilfumarat blev kombineret med lamivudin og abacavir eller med lamivudin og didanosin, indgivet en gang dagligt.
There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when tenofovir disoproxil fumarate was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Der er tæt strukturel lighed imellem lamivudin og emtricitabin og ligheder i disse to stoffers farmakokinetik og farmakodynamik.
There is close structural similarity between lamivudine and emtricitabine and similarities in the pharmacokinetics and pharmacodynamics of these two agents.
Derfor kan de samme problemer muligvis ses, hvis Truvada indgives sammen med en tredje nukleosidanalog.
Therefore, the same problems may be seen if Truvada is administered with a third nucleoside analogue.
Patienter, som får Truvada eller en anden antiretroviral behandling, kan fortsætte med at udvikle opportunistiske infektioner og andre komplikationer af HIV- infektionen og bør derfor holdes under
Patients receiving Truvada or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
3 nøje klinisk observation af læger, som har erfaring i behandlingen af patienter med HIV- associerede sygdomme.
3 Renal impairment:
Desuden skal nyrefunktionen (kreatinin- clearance og serumfosfat) også overvåges hver fjerde uge i løbet af det første år og derefter hver tredje måned.
It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with Truvada and renal function (creatinine clearance and serum phosphate) is also monitored every four weeks during the first year and then every three months.
Hos patienter med risiko for nedsat nyrefunktion, herunder patienter, som tidligere har haft nyreproblemer, når de fik adefovirdipivoxil, bør det overvejes at gennemføre en hyppigere overvågning af nyrefunktionen.
In patients at risk for renal impairment, including patients who have previously experienced renal events while receiving adefovir dipivoxil, consideration should be given to more frequent monitoring of renal function.
Patienter med nedsat nyrefunktion (kreatinin- clearance < 80 ml/ min), herunder hæmodialysepatienter:
Patients with renal impairment (creatinine clearance < 80 ml/ min), including haemodialysis patients:
Der er kun udført meget begrænsede undersøgelser af Truvadas sikkerhed i forhold til nyrerne hos patienter med nedsat nyrefunktion (kreatinin- clearance < 80 ml/ min).
Renal safety with Truvada has only been studied to a very limited degree in patients with impaired renal function (creatinine clearance < 80 ml/ min).
4. 2).
Dose interval adjustments are recommended for patients with creatinine clearance 30-49 ml/ min (see section 4.2).
Begrænsede data fra kliniske undersøgelser antyder, at det forlængede dosisinterval ikke er optimalt, og at det kan resultere i øget toksicitet og mulig inadækvat respons.
Limited clinical study data suggest that the prolonged dose interval is not optimal and could result in increased toxicity and possibly inadequate response.
5. 2).
Furthermore, in a small clinical study, a subgroup of patients with creatinine clearance between 50 and 60 ml/ min who received tenofovir disoproxil fumarate in combination with emtricitabine every 24 hours had a 2-4-fold higher exposure to tenofovir and worsening of renal function (see section 5.2).
Derfor er det nødvendigt at foretage en nøje vurdering af fordele og risici, når Truvada anvendes hos patienter med kreatinin- clearance < 60 ml/ min, og nyrefunktion bør overvåges nøje.
Therefore, a careful benefit-risk assessment is needed when Truvada is used in patients with creatinine clearance < 60 ml/ min, and renal function should be closely monitored.
Desuden bør den kliniske respons på behandlingen overvåges nøje hos patienter, som får Truvada med forlænget dosisinterval.
In addition, the clinical response to treatment should be closely monitored in patients receiving Truvada at a prolonged dosing interval.
4. 2 og 5. 2).
The use of Truvada is not recommended in patients with severe renal impairment (creatinine clearance < 30 ml/ min) and in patients who require haemodialysis since appropriate dose reductions cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
4. 8, proksimal tubulopati).
If serum phosphate is < 1.5 mg/ dl (0.48 mmol/ l) or creatinine clearance is decreased to < 50 ml/ min in any patient receiving Truvada, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Det bør også overvejes at afbryde behandlingen med Truvada hos patienter med kreatinin - clearance på under < 50 ml/ min eller fald i serumfosfat til < 1, 0 mg/ dl (0, 32 mmol/ l).
Consideration should also be given to interrupting treatment with Truvada in patients with creatinine clearance decreased to < 50 ml/ min or decreases in serum phosphate to < 1.0 mg/ dl (0.32 mmol/ l).
4. 5).
Use of Truvada should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
5. 1).
Truvada should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
Knogleeffekter:
Bone effects:
I en 144- ugers kontrolleret, klinisk undersøgelse, som sammenlignede tenofovirdisoproxilfumarat med stavudin i kombination med lamivudin og efavirenz hos antiretroviral - naive patienter, sås små reduktioner i knoglemineraltætheden i hoften og rygraden hos begge behandlingsgrupper.
In a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density of the hip and spine were observed in both treatment groups.
Reduktionerne i knoglemineraltætheden i rygraden og ændringerne i knoglebiomarkører fra baselinie var i uge 144 signifikant større i gruppen, der blev behandlet med tenofovirdisoproxilfumarat.
Decreases in bone mineral density of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil fumarate treatment group at 144 weeks.
I denne gruppe var reduktionerne i knoglemineraltætheden i hoften signifikant større indtil uge 96.
Decreases in bone mineral density of hip were significantly greater in this group until 96 weeks.
4 Patienter med HIV, som samtidig er inficerede med hepatitis B - eller C- virus:
4 Patients with HIV and hepatitis B or C virus co-infection:
Hos patienter med kronisk hepatitis B eller C, som er i antiretroviral behandling, er der en øget risiko for svære og potentielt fatale, hepatiske uønskede reaktioner.
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Læger bør holde sig til de aktuelle HIV- behandlingsretningslinjer for optimal håndtering af HIV- infektion hos patienter med samtidig infektion med hepatitis B- virus (HBV).
Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with hepatitis B virus (HBV).
Sikkerheden og virkningen af Truvada er ikke godtgjort for behandlingen af kronisk HBV- infektion.
The safety and efficacy of Truvada have not been established for the treatment of chronic HBV infection.
Begrænset klinisk erfaring tyder på, at emtricitabin og tenofovirdisoproxilfumarat har anti- HBV- aktivitet, når det anvendes i antiretroviral kombinationsbehandling for at kontrollere HIV- infektion.
Limited clinical experience suggests that emtricitabine and tenofovir disoproxil fumarate have anti-HBV activity when used in antiretroviral combination therapy to control HIV infection.
Seponering af behandlingen med Truvada hos HIV- inficerede patienter, der samtidig er inficeret med HBV, kan være forbundet med svær, akut forværring af hepatitis.
Discontinuation of Truvada therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Patienter med HIV- infektion, som samtidig er inficerede med HBV, og som ophører med Truvada, bør overvåges nøje med både klinisk og laboratorisk opfølgning i mindst flere måneder efter, behandlingen med Truvada ophører.
Patients co-infected with HIV and HBV who discontinue Truvada should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Genoptagelse af hepatitis B- behandlingen kan være nødvendig.
If appropriate, resumption of hepatitis B therapy may be warranted.
Sikkerheden og virkningen af Truvada er ikke godtgjort hos patienter med signifikante, tilgrundliggende leversygdomme.
The safety and efficacy of Truvada have not been established in patients with significant underlying liver disorders.
5. 2).
Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for Truvada in patients with hepatic impairment (see section 5.2).
Hos patienter med tidligere tilfælde af leverdysfunktion, herunder kronisk aktiv hepatitis, er der en forhøjet forekomst af unormal leverfunktion under antiretroviral kombinationsbehandling, og disse patienter bør overvåges i henhold til standardprocedurer.
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Laktatacidose:
Lactic acidosis:
Laktatacidose, som regel forbundet med steatosis hepatis, er blevet indberettet i forbindelse med brugen af nukleosidanaloger.
Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues.