natgillin/translations-raw huggingface dataset:
Tenofovirdisoproxilfumarat bør undgås hos tidligere antiretroviral- behandlede patienter med HIV- 1 med stammer, som har K65R- mutationer.
Tenofovir disoproxil fumarate should be avoided in patients with HIV-1 harbouring the K65R mutation.
Patienter, hvis HIV- 1 udtrykte 3 eller flere thymidin- analog- forbundne mutationer (TAMs), som omfattede enten M41L - eller L210W- revers transkriptasemutation, udviste reduceret følsomhed over for tenofovirdisoproxilfumarat.
Patients with HIV-1 expressing three or more thymidine analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced susceptibility to tenofovir disoproxil fumarate.
In vivo- resistens (antiretroviral- naive patienter):
In vivo resistance (antiretroviral-naïve patients):
I en åben, randomiseret, klinisk undersøgelse (GS- 01- 934) med antiretroviral- naive patienter blev der foretaget genotypebestemmelser på plasma - HIV- 1- isolater fra alle patienter med bekræftet HIV RNA > 400 kopier/ ml ved uge 48, 96 eller 144 eller på tidspunktet for tidlig seponering af forsøgsmedicinen.
In an open-label randomised clinical study (GS-01-934) in antiretroviral-naïve patients, genotyping was performed on plasma HIV-1 isolates from all patients with confirmed HIV RNA > 400 copies/ ml at weeks 48, 96 or 144 or at the time of early study drug discontinuation.
• M184V/ I- mutationen udviklede sig hos 2/ 19 (10, 5%) af de isolater, der blev analyseret fra patienter i emtricitabin/ tenofovirdisoproxilfumarat/ efavirenz- gruppen og hos 10/ 29 (34, 5%) af de isolater, der blev analyseret fra lamivudin/ zidovudin/ efavirenz- gruppen (p- værdi < 0, 05; Fisher’ s Exact test, her sammenligning af alle patienterne fra henholdsvis emtricitabin+tenofovirdisoproxilfumarat- gruppen med lamivudin/ zidovudin- gruppen). • Ingen analyseret virus indeholdt K65R- mutationen. • Genotyperesistens over for efavirenz, især K103N- mutationen, udviklede sig i virus fra 13/ 19 (68%) af patienterne i emtricitabin/ tenofovirdisoproxilfumarat/ efavirenz- gruppen og i virus fra 21/ 29 (72%) af patienterne i sammenligningsgruppen.
• The M184V/ I mutation developed in 2/ 19 (10.5%) isolates analysed from patients in the emtricitabine/ tenofovir disoproxil fumarate/ efavirenz group and in 10/ 29 (34.5%) isolates analysed from the lamivudine/ zidovudine/ efavirenz group (p-value < 0.05, Fisher’ s Exact test comparing the emtricitabine+tenofovir disoproxil fumarate group to the lamivudine/ zidovudine group among all subjects). • No virus analysed contained the K65R mutation. • Genotypic resistance to efavirenz, predominantly the K103N mutation, developed in virus from 13/ 19 (68%) patients in the emtricitabine/ tenofovir disoproxil fumarate/ efavirenz group and in virus from 21/ 29 (72%) patients in the comparative group.
I en åben, randomiseret, klinisk undersøgelse (GS- 01- 934) fik antiretroviral- naive patienter inficeret med HIV- 1 et regime med enten emtricitabin, tenofovirdisoproxilfumarat og efavirenz en gang daglig (n=255) eller en kombinationsformulering med lamivudin og zidovudin (Combivir) administreret to gange daglig og efavirenz en gang daglig (n=254).
In an open-label randomised clinical study (GS-01-934), antiretroviral-naïve HIV-1 infected patients received either a once daily regimen of emtricitabine, tenofovir disoproxil fumarate and efavirenz (n=255) or a fixed combination of lamivudine and zidovudine (Combivir) administered twice daily and efavirenz once daily (n=254).
Patienterne i emtricitabin - og tenofovirdisoproxilfumarat- gruppen fik Truvada og efavirenz fra uge 96 til uge 144.
Patients in the emtricitabine and tenofovir disoproxil fumarate group were given Truvada and efavirenz from week 96 to week 144.
Ved baseline havde de randomiserede grupper nogenlunde samme mediane plasma HIV- 1 RNA (5, 02 og 5, 00 log10 kopier/ ml) og CD4- tal (233 og 241 celler/ mm3).
At baseline the randomised groups had similar median plasma HIV-1 RNA (5.02 and 5.00 log10 copies/ ml) and CD4 counts (233 and 241 cells/ mm3).
Denne undersøgelses primære virknings- endpoint var at opnå og vedligeholde bekræftede HIV- 1 RNA- koncentrationer < 400 kopier/ ml i 48 uger.
The primary efficacy endpoint for this study was the achievement and maintenance of confirmed HIV-1 RNA concentrations < 400 copies/ ml over 48 weeks.
Sekundære virkningsanalyser i løbet af de 144 uger omfattede andelen af patienter med HIV- 1 RNA- koncentrationer < 400 eller < 50 kopier/ ml og en ændring i CD4- celletallet fra baseline.
Secondary efficacy analyses over 144 weeks included the proportion of patients with HIV-1 RNA concentrations < 400 or < 50 copies/ ml, and change from baseline in CD4 cell count.
Dette vises i tabel 1.
The 48-week primary endpoint data showed that the combination of emtricitabine, tenofovir disoproxil fumarate and efavirenz provided superior antiviral efficacy as compared with the fixed combination of lamivudine and zidovudine (Combivir) with efavirenz as shown in Table 1.
De sekundære endpoint - data fra uge 144 vises også i tabel 1.
The 144 week secondary endpoint data are also presented in Table 1.
11 Tabel 1:
11 Table 1:
48 - og 144- ugers data vedrørende virkning fra undersøgelse GS- 01- 934, hvor emtricitabin, tenofovirdisoproxilfumarat og efavirenz blev administreret til antiretroviral- naive patienter med HIV- 1.
48- and 144-week efficacy data from study GS-01-934 in which emtricitabine, tenofovir disoproxil fumarate and efavirenz were administered to antiretroviral-naïve patients with HIV-1 infection
Tenofovirdisoproxil - zidovudin+efavirenz fumarat+efavirenz
tenofovir disoproxil fumarate+efavirenz
Tenofovirdisoproxil - fumarat+efavirenz *
tenofovir disoproxil fumarate+efavirenz*
zidovudin+efavirenz
zidovudine+efaviren z
HIV- 1 RNA < 400 kopier/ ml (TLOVR)
HIV-1 RNA < 400 copies/ ml (TLOVR)
84% (206/ 244) 73% (177/ 243)
73% (177/ 243)
% forskel (95% CI)
% difference (95%CI)
11% (4% til 19%)
11%
13% (4% til 22%)
13%
HIV- 1 RNA < 50 kopier / ml (TLOVR)
HIV-1 RNA < 50 copies/ ml (TLOVR)
9% (2% til 17%)
9%
8%
(2% to 17%)
(- 1% til 17%)
8% (-1% to 17%)
Middel ændring fra baseline i CD4- celletal (celler/ mm3)
Mean change from baseline in CD4 cell count (cells/ mm3)
p- værdi Forskel (95% CI)
p-value Difference (95%CI)
0, 002a 32 (9 til 55)
0.002a 32 (9 to 55)
0, 089a 41 (4 til 79)
0.089a 41 (4 to 79)
* Patienter, som fik emtricitabin, tenofovirdisoproxilfumarat og efavirenz, fik Truvada plus efavirenz fra uge 96 til 144. ** p- værdien baseret på Cochran- Mantel- Haenszel- testen stratificeret til CD4- celletal ved baseline TLOVR=Time to Loss of Virologic Response (tiden til tab af virologisk respons) a:
* Patients receiving emtricitabine, tenofovir disoproxil fumarate and efavirenz were given Truvada plus efavirenz from week 96 to 144. ** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count TLOVR=Time to Loss of Virologic Response a:
Van Elteren- test
Van Elteren Test
I en separat, randomiseret, klinisk undersøgelse (M02- 418) blev 190 antiretroviral- naive voksne også behandlet en gang daglig med emtricitabin og tenofovirdisoproxilfumarat i kombination med lopinavir/ ritonavir indgivet en eller to gange daglig.
In a separate randomised clinical study (M02-418), one hundred and ninety antiretroviral-naïve adults were also treated once daily with emtricitabine and tenofovir disoproxil fumarate in combination with lopinavir/ ritonavir given once or twice daily.
I uge 48 af behandlingen udviste 70% og 64% af patienterne HIV- 1 RNA < 50 kopier/ ml med henholdsvis en og to gange daglig behandling med lopinavir/ ritonavir.
At 48 weeks, 70% and 64% of patients demonstrated HIV-1 RNA < 50 copies/ ml with the once and twice daily regimens of lopinavir/ ritonavir, respectively.
Middelændringerne i CD4- celletallet fra baseline var +185 celler/ mm3 og +196 celler/ mm3 med henholdsvis en og to gange daglig behandling med lopinavir/ ritonavir.
The mean changes in CD4 cell count from baseline were +185 cells/ mm3 and +196 cells/ mm3 with the once and twice daily regimens of lopinavir/ ritonavir, respectively.
4. 4).
Limited clinical experience in patients co-infected with HIV and HBV suggests that treatment with emtricitabine or tenofovir disoproxil fumarate in antiretroviral combination therapy to control HIV infection also results in a reduction in HBV DNA (3 log10 reduction or 4 to 5 log10 reduction, respectively) (see section 4.4).
Bioækvivalensen mellem én Truvada filmovertrukken tablet og en emtricitabin 200 mg hård kapsel og en tenofovirdisoproxilfumarat 245 mg filmovertrukken tablet blev fastlagt efter indgivelse af en enkelt dosis hos fastende, sunde probander.
The bioequivalence of one Truvada film-coated tablet with one emtricitabine 200 mg hard capsule and one tenofovir disoproxil fumarate 245 mg film-coated tablet was established following single dose administration to fasting healthy subjects.
Efter peroral indgivelse af Truvada hos sunde probander absorberes emtricitabin og tenofovirdisoproxilfumarat hurtigt, og tenofovirdisoproxilfumarat omdannes til tenofovir.
Following oral administration of Truvada to healthy subjects, emtricitabine and tenofovir disoproxil fumarate are rapidly absorbed and tenofovir disoproxil fumarate is converted to tenofovir.
Maksimale koncentrationer af emtricitabin og tenofovir ses i serum inden for 0, 5 til 3, 0 timer efter indgivelse i fastende tilstand.
Maximum emtricitabine and tenofovir concentrations are observed in serum within 0.5 to 3.0 h of dosing in the fasted state.
35% og 15%, når det blev indgivet sammen med et let måltid eller et måltid med højt fedtindhold, sammenlignet med indgivelse i fastende tilstand.
Administration of Truvada with food resulted in a delay of approximately three quarters of an hour in reaching maximum tenofovir concentrations and increases in tenofovir AUC and Cmax of approximately 35% and 15%, respectively, when administered with a high fat or light meal, compared to administration in the fasted state.
Fordeling:
12 Distribution:
Efter intravenøs indgivelse blev emtricitabins og tenofovirs fordelingsvolumen vurderet til at være henholdsvis 1, 4 l/ kg og 800 ml/ kg.
Following intravenous administration the volume of distribution of emtricitabine and tenofovir was approximately 1.4 l/ kg and 800 ml/ kg, respectively.
12 Emtricitabins binding in vitro til humane plasmaproteiner var < 4% og uafhængig af koncentrationsområdet på 0, 02- 200 µg/ ml.
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/ ml.
Tenofovirs proteinbinding in vitro til plasma - eller serumproteiner var mindre end henholdsvis 0, 7 og 7, 2% i tenofovirkoncentrationsområdet på 0, 01- 25 µg/ ml.
In vitro protein binding of tenofovir to plasma or serum protein was less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 µg/ ml.
Hverken emtricitabin eller tenofovir hæmmede in vitro lægemiddelmetaboliseringen medieret af en hvilken som helst af de CYP450- isoformer, der er involveret i lægemiddelbiotransformationen.
Neither emtricitabine nor tenofovir inhibited in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation.
70- 80% af dosen udskilles uomdannet i urinen efter intravenøs indgivelse.
Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
210 ml/ min, hvilket er over den glomerulære filtrationshastighed.
Renal clearance has been estimated to be approximately 210 ml/ min, which is in excess of the glomerular filtration rate.
Emtricitabins og tenofovirs farmakokinetik er den samme for mænd og kvinder.
Emtricitabine and tenofovir pharmacokinetics are similar in male and female patients.
Generelt ligner emtricitabins farmakokinetik hos spædbørn, børn og unge (fra 4 måneder til 18 år) den hos voksne.
In general, the pharmacokinetics of emtricitabine in infants, children and adolescents (aged 4 months up to 18 years) are similar to those seen in adults.
Der er ikke foretaget farmakokinetiske undersøgelser med tenofovir hos børn og unge (under 18 år).
Pharmacokinetic studies have not been performed with tenofovir in children and adolescents (under 18 years).
Der er ikke foretaget farmakokinetiske undersøgelser med emtricitabin eller tenofovir hos ældre (over 65 år).
Pharmacokinetic studies have not been performed with emtricitabine or tenofovir in the elderly (over 65 years).
Farmakokinetiske parametre blev hovedsageligt bestemt efter indgivelse af enkelte doser emtricitabin 200 mg eller tenofovirdisoproxil 245 mg til ikke- HIV- inficerede patienter med forskellige grader af nedsat nyrefunktion.
Pharmacokinetic parameters were mainly determined following administration of single doses of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected patients with varying degrees of renal impairment.
Graden af nedsat nyrefunktion blev defineret i henhold til kreatinin- clearance (CrCl) ved baselinie (normal nyrefunktion med CrCl > 80 ml/ min; let nedsat nyrefunktion med CrCl = 50- 79 ml/ min; moderat nedsat nyrefunktion med CrCl = 30- 49 ml/ min og svært nedsat nyrefunktion med CrCl = 10- 29 ml/ min).
The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 ml/ min; mild impairment with CrCl = 50-79 ml/ min; moderate impairment with CrCl = 30-49 ml/ min and severe impairment with CrCl = 10-29 ml/ min).
Den gennemsnitlige (% variationskoefficient) emtricitabineksponering steg fra 12 (25%) µg• t/ ml hos probander med normal nyrefunktion til 20 (6%) µg• t/ ml, 25 (23%) µg• t/ ml og 34 (6%) µg• t/ ml hos patienter med henholdsvis let, moderat og svært nedsat nyrefunktion.
The mean (%CV) emtricitabine drug exposure increased from 12 (25%) µg• h/ ml in subjects with normal renal function, to 20 (6%) µg• h/ ml, 25 (23%) µg• h/ ml and 34 (6%) µg• h/ ml, in patients with mild, moderate and severe renal impairment, respectively.
Den gennemsnitlige (% variationskoefficient) tenofovireksponering steg fra 2. 185 (12%) ng• t/ ml hos probander med normal nyrefunktion til 3. 064 (30%) ng• t/ ml, 6. 009 (42%) ng• t/ ml og 15. 985 (45%) ng• t/ ml hos patienter med henholdsvis let, moderat og svært nedsat nyrefunktion.
The mean (%CV) tenofovir drug exposure increased from 2,185 (12%) ng• h/ ml in patients with normal renal function, to 3,064 (30%) ng• h/ ml, 6,009 (42%) ng• h/ ml and 15,985 (45%) ng• h/ ml, in patients with mild, moderate and severe renal impairment, respectively.
Det øgede dosisinterval for Truvada hos patienter med moderat nedsat nyrefunktion forventes at resultere i højere peak- plasmakoncentrationer og lavere Cmin- niveauer sammenlignet med patienter med normal nyrefunktion.
The increased dose interval for Truvada in patients with moderate renal impairment is expected to result in higher peak plasma concentrations and lower Cmin levels as compared to patients with normal renal function.
Hos patienter med end- stage renal sygdom (ESRD), som havde behov for hæmodialyse, steg lægemiddelkoncentrationen betragteligt imellem dialyserne over et tidsrum på 72 timer til 53 (19%) µg• t/ ml og tenofovirs koncentration steg over et tidsrum på 48 timer til 42. 857 (29%) ng• t/ ml.
13 In patients with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 (19%) µg• h/ ml of emtricitabine, and over 48 hours to 42,857 (29%) ng• h/ ml of tenofovir.
13 Det anbefales, at dosisintervallet for Truvada justeres hos patienter med kreatinin- clearance mellem 30 og 49 ml/ min.
It is recommended that the dosing interval for Truvada is modified in patients with creatinine clearance between 30 and 49 ml/ min.
4. 2).
Truvada is not suitable for patients with CrCl < 30 ml/ min or for those on haemodialysis (see section 4.2).
En lille klinisk undersøgelse blev udført for at vurdere sikkerhed, antiviral aktivitet og farmakokinetik for tenofovirdisoproxilfumarat i kombination med emtricitabin hos HIV- inficerede patienter med nedsat nyrefunktion.
A small clinical study was conducted to evaluate the safety, antiviral activity and pharmacokinetics of tenofovir disoproxil fumarate in combination with emtricitabine in HIV infected patients with renal impairment.
En undergruppe af patienterne med baseline- kreatinin- clearance mellem 50 og 60 ml/ min, som fik én daglig dosis, havde en 2- 4 gange højere eksponering for tenofovir og desuden forværring af nyrefunktionen.
A subgroup of patients with baseline creatinine clearance between 50 and 60 ml/ min, receiving once daily dosing, had a 2-4-fold increase in tenofovir exposure and worsening renal function.
Truvadas farmakokinetik er ikke undersøgt hos patienter med nedsat leverfunktion.
The pharmacokinetics of Truvada have not been studied in patients with hepatic impairment.
Det er imidlertid usandsynligt, at en dosisjustering af Truvada vil være nødvendig hos patienter med nedsat leverfunktion.
However, it is unlikely that a dose adjustment would be required for Truvada in patients with hepatic impairment.
Emtricitabins farmakokinetik er ikke blevet undersøgt hos ikke- HBV- inficerede patienter med forskellige grader af leverinsufficiens.
The pharmacokinetics of emtricitabine have not been studied in non-HBV infected subjects with varying degrees of hepatic insufficiency.
Generelt lignede emtricitabins farmakokinetik hos HBV- inficerede patienter den hos raske probander og hos HIV- inficerede patienter.
In general, emtricitabine pharmacokinetics in HBV infected subjects were similar to those in healthy subjects and in HIV infected subjects.
En enkelt dosis af tenofovirdisoproxil 245 mg blev indgivet til ikke- HIV- inficerede patienter med forskellige grader af nedsat leverfunktion defineret i henhold til Child- Pugh- Turcotte (CPT) klassifikationen.
A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected patients with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Tenofovirs gennemsnitlige (% variationskoefficient) Cmax - og AUC0- ∞- værdier var henholdsvis 223 (34, 8%) ng/ ml og 2. 050 (50, 8%) ng• t/ ml hos probander med normal leverfunktion sammenlignet med 289 (46, 0%) ng/ ml og 2. 310 (43, 5%) ng• t/ ml hos probander med moderat nedsat leverfunktion og 305 (24, 8%) ng/ ml og 2. 740 (44, 0%) ng• t/ ml hos probander med svært nedsat leverfunktion.
The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/ ml and 2,050 (50.8%) ng• h/ ml, respectively, in normal subjects compared with 289 (46.0%) ng/ ml and 2,310 (43.5%) ng• h/ ml in subjects with moderate hepatic impairment, and 305 (24.8%) ng/ ml and 2,740 (44.0%) ng• h/ ml in subjects with severe hepatic impairment.
De præ- kliniske data for emtricitabin viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Prækliniske undersøgelser af tenofovirdisoproxilfumarat udført på rotter, hunde og aber afslørede målorganvirkninger i mave- tarm- kanalen, nyrer, knogler og et fald i serumfosfatkoncentrationen.
Preclinical studies of tenofovir disoproxil fumarate conducted in rats, dogs and monkeys revealed target organ effects in gastrointestinal tract, kidney, bone and a decrease in serum phosphate concentration.
Fund ved undersøgelser af rotter og aber viste, at der var en stofrelateret reduktion i den intestinale absorption af fosfat med potentiel, sekundær reduktion af knoglemineraltæthed.
Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in bone mineral density.
Konventionelle reproduktive/ udviklingstoksiske undersøgelser med emtricitabin og tenofovirdisoproxilfumarat viser ingen særlig risiko for mennesker.
Conventional reproductive/ developmental toxicity studies with emtricitabine and tenofovir disoproxil fumarate reveal no special hazard for humans.
Tenofovirdisoproxilfumarat var positiv i to ud af tre in vitro- genotoksicitetsundersøgelser, men negativ i in vivo- mikronukleusanalysen.
Tenofovir disoproxil fumarate was positive in two out of three in vitro genotoxicity studies but negative in the in vivo micronucleus assay.
En langtidsundersøgelse af karcinogenicitet hos mus ved peroral indgift viste en lav forekomst af duodenaltumorer, hvilket synes at være relateret til høj lokal koncentration i mave- tarm- kanalen ved en dosis på 600 mg/ kg/ dag.
A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumours, considered likely related to high local concentrations in the gastrointestinal tract at a dose of 600 mg/ kg/ day.
14 alene.
14 The combination of emtricitabine and tenofovir disoproxil fumarate was positive in the in vitro mouse lymphoma assay, with comparable results to those obtained for tenofovir disoproxil fumarate alone.
I en undersøgelse af en måneds varighed med hunde, hvor kombinationen af emtricitabin og tenofovirdisoproxilfumarat anvendtes, blev der ikke fundet nogen forværring af toksikologiske virkninger sammenlignet med de separate indholdsstoffer.
A one month dog study using the combination of emtricitabine and tenofovir disoproxil fumarate, found no exacerbation of toxicological effects compared to the separate components.
Glyceroltriacetat (E1518) Hypromellose (E464) Indigocarmin aluminiumpigment (E132) Lactosemonohydrat Titandioxid (E171)
Glycerol triacetate (E1518) Hypromellose (E464) Indigo carmine aluminium lake (E132) Lactose monohydrate Titanium dioxide (E171)
Truvada leveres i en HD- polyethylen (HDPE) - flaske med børnesikret lukke indeholdende 30 filmovertrukne tabletter sammen med silicagel.
HDPE bottle with a child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
Cork, Irland
Cork, Ireland
20 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
ETIKETTERING PÅ PAKNING OG FLASKE
BOTTLE AND CARTON LABELLING
Truvada 200 mg/ 245 mg filmovertrukne tabletter Emtricitabin/ tenofovirdisoproxil
Truvada 200 mg/ 245 mg film-coated tablets Emtricitabine/ tenofovir disoproxil
3 x 30 filmovertrukne tabletter.
3 x 30 film-coated tablets.
EU/ 1/ 04/ 305/ 001 30 filmovertrukne tabletter EU/ 1/ 04/ 305/ 001 3 x 30 filmovertrukne tabletter
EU/ 1/ 04/ 305/ 001 30 film-coated tablets EU/ 1/ 04/ 305/ 002 3 x 30 film-coated tablets
- Lægen har ordineret Truvada til Dem personligt.
- This medicine has been prescribed for you.
Virkning og anvendelse 2.
What Truvada is and what it is used for 2.
Det skal De vide, før De begynder at tage Truvada 3.
Before you take Truvada 3.
Sådan skal De tage Truvada 4.
How to take Truvada 4.
Opbevaring 6.
How to store Truvada 6.
VIRKNING OG ANVENDELSE
WHAT TRUVADA IS AND WHAT IT IS USED FOR
Truvada anvendes til behandling af infektion med humant immundefekt virus (HIV) hos voksne over 18 år.
Truvada is a treatment for Human Immunodeficiency Virus (HIV) infection in adults over 18 years of age.
Begge disse aktive stoffer er antiretrovirale lægemidler, som anvendes til behandling af HIV- infektion.
Both of these active substances are antiretroviral medicines which are used to treat HIV infection.
Emtricitabin hører til en gruppe lægemidler, der kaldes nukleosid- revers transkriptase- hæmmere, og tenofovir hører til en gruppe, der kaldes nukleotid- revers transkriptase- hæmmere.
Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor.