FrancophonIA/ELRC3.0 huggingface dataset:
English: Assessment of adverse reactions related to tenofovir disoproxil is based on two randomised trials (studies GS-US 104-0321 and GS-US-104-0352) in 184 HIV-1 infected paediatric patients (aged 2 to < 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1).
Danish: Vurderingen af bivirkninger i forbindelse med tenofovirdisoproxil er baseret på to randomiserede studier (studierne GS-US-104-0321 og GS-US-104-0352) hos 184 HIV 1-inficerede pædiatriske patienter (2 år til < 18 år), som fik behandling med tenofovirdisoproxil (n = 93) eller placebo/aktiv komparator (n = 91) i kombination med andre antiretrovirale stoffer i 48 uger (se pkt.
English: Exacerbations of hepatitis after discontinuation of treatment In HBV infected patients, clinical and laboratory evidence of hepatitis have occurred after discontinuation of treatment (see section 4.4).
Danish: Hos HBV-inficerede patienter er der forekommet klinisk og laboratoriemæssig evidens for hepatitis efter seponering af behandlingen (se pkt.
English: P-valuea, b mITT Analysis Seroconversions / N Relative Risk Reduction (95% CI)b URAI Within 12 Weeks Prior to Screening, mITT Analysis Seroconversions / N Relative Risk Reduction (95% CI)b a P-values by logrank test. P-values for URAI refer to the null hypothesis that efficacy differed between subgroup strata (URAI, no URAI).
Danish: Relativ risikoreduktion(95% CI)b a P-værdier efter logrank test. P-værdien for URAI henviser til den nulhypotese, at virkningen var forskellig mellem undergruppestrata (URAI, ingen URAI).
English: • Emtricitabine/Tenofovir disoproxil Zentiva can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva kan administreres i stedet for emtricitabin og tenofovirdisoproxil anvendt hver for sig med samme doser.
English: Involved in Transactional Sex Last 6 Month, N (%) Known HIV+ Partner Last 6 Months, N (%) Syphilis Seroreactivity, N (%) Serum Herpes Simplex Virus Type 2 Infection, N (%) Urine Leukocyte Esterase Positive, N (%) URAI = unprotected receptive anal intercourse
Danish: Serumpåvist herpes simplex virus type 2-infektion, N (%) Urin-leukocytesterase-positiv, N (%) URAI = ubeskyttet receptivt analt samleje
English: In 2 of 14 subjects who had acute HIV infection at study enrollment, the K65R mutation was detected in the HIV of 1 of 5 subjects in the tenofovir disoproxil 245 mg group and the M184V mutation (associated with resistance to emtricitabine) was detected in the HIV of 1 of 3 subjects in the emtricitabine/tenofovir disoproxil group.
Danish: Hos 2 ud af 14 patienter, som havde akut HIV-infektion ved optagelse i studiet, blev K65R-mutationen påvist i HIV 1 hos 5 forsøgspersoner i tenofovirdisoproxil 245 mg-gruppen, og M184V-mutationen (forbundet med resistens over for emtricitabin) blev påvist i HIV hos 1 ud af 3 forsøgspersoner i emtricitabin/tenofovirdisoproxil-gruppen.
English: Hydrophobic colloidal silica Magnesium stearate
Danish: Hydrofob kolloid silica Magnesiumstearat
English: IMMUNOSUPPRESSANTS Tacrolimus/tenofovir disoproxil /emtricitabine
Danish: IMMUNSUPPRESSIVA Tacrolimus/Tenofovirdisoproxil/ Emtricitabin
English: Five subjects (5.6%) had laboratory findings clinically consistent with proximal renal tubulopathy, 4 of whom discontinued tenofovir disoproxil therapy (median tenofovir disoproxil exposure 331 weeks).
Danish: 5 orsøgsdeltagere (5,6%) havde laboratoriefund, der var klinisk overensstemmende med proksimal renal tubulopati, og 4 af disse fik seponeret behandlingen med tenofovirdisoproxil (median eksponering for tenofovirdisoproxil var 331 uger).
English: In study GS-US-104-0352, 89 HIV-1 infected paediatric patients with a median age of 7 years (range 2 to 15 years) were exposed to tenofovir disoproxil for a median of 331 weeks.
Danish: I studiet GS-US-104-0352 blev 89 HIV 1-inficerede pædiatriske patienter med en medianalder på 7 år (2-15 år) eksponeret for tenofovirdisoproxilfumarat i en median periode på 331 uger.
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z-score, and -0.184 and -0.027 in total body BMD Z-score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Danish: De gennemsnitlige ændringer i BMD Z-score i uge 48 (afslutningen på den randomiserede fase) var 0,032 og 0,087 i lænderygsøjlen og -0,184 og0,027 i hele kroppen for henholdsvis tenofovirdisoproxil og stavudin eller zidovudin.
English: Blood and lymphatic system disorders Common neutropenia
Danish: Blod og lymfesystem Almindelig:
English: Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease.
Danish: Nogle af de mange risikofaktorer for at udvikle denne sygdom er, hvis du tager denne type medicin i længere tid, tager kortikosteroider, drikker alkohol, hvis du har et meget svagt immunsystem, eller hvis du er overvægtig.
English: Common pain, asthenia 1 This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Danish: 1 Denne bivirkning kan forekomme som resultat af proksimal renal tubulopati.
English: If you think you may have lactic acidosis, get medical help immediately.
Danish: Hvis du tror, du har laktatacidose, skal du straks søge læge.
English: The adverse reaction profile of emtricitabine and tenofovir disoproxil in a limited number of HIVinfected patients in study GS-01-934 who were co-infected with HBV (n = 13) or HCV (n = 26) was similar to that observed in patients infected with HIV without co-infection.
Danish: I studie GS-01-934 lignede bivirkningsprofilen for emtricitabin og tenofovirdisoproxil hos et begrænset antal HIV-inficerede patienter, der samtidig var inficeret med HBV (n = 13) eller HCV (n = 26) bivirkningsprofilen hos patienter, som kun er inficerede med HIV.
English: Only samples from subjects randomized to emtricitabine/tenofovir disoproxil were evaluated for detectable plasma or intracellular tenofovir disoproxil-DP levels.
Danish: Kun prøver fra forsøgspersoner, der blev randomiseret til emtricitabin/tenofovirdisoproxil, blev vurderet for detekterbare plasma- eller intracellulære tenofovirdisoproxil-DP-niveauer.
English: Do not stop taking Emtricitabine/Tenofovir disoproxil Zentiva without contacting your doctor.
Danish: Hold ikke op med at tage Emtricitabine/Tenofovir disoproxil Zentiva uden først at have talt med din læge.
English: Relative Risk Reduction (95% CI)
Danish: Relativ risikoreduktion(95% CI)
English: • Emtricitabine/Tenofovir disoproxil Zentiva may affect your kidneys.
Danish: • Emtricitabine/Tenofovir disoproxil Zentiva kan have indvirkning på Deres nyrer.
English: • vancomycin (for bacterial infection).
Danish: • vancomycin (mod bakterieinfektion)
English: • aminoglycosides (for bacterial infection).
Danish: • aminoglykosider (mod bakterieinfektion)
English: Clinical efficacy and safety of emtricitabine/tenofovir disoproxil was established from studies conducted with emtricitabine and tenofovir disoproxil when given as single agents.
Danish: Emtricitabin/tenoforvirdisoproxils kliniske virkning og sikkerhed blev fastlagt ud fra studier, der er udført med emtricitabin og tenofovirdisoproxil givet som enkeltstoffer.
English: There are no data on the long term renal and bone effects of emtricitabine/tenofovir disoproxil when used for pre-exposure prophylaxis in uninfected adolescents (see section 5.1).
Danish: Der findes ingen data om langtidsvirkningen af emtricitabin/tenofovirdisoproxil på nyrer og knogler, når det anvendes til profylakse før eksponering hos ikke-inficerede unge (se pkt.
English: In subjects 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
Danish: Hos forsøgspersoner med nyresygdom i slutstadiet (End Stage Renal Disease, 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.
English: Co-administration of sofosbuvir/velpatasvir with efavirenz-containing regimens is not recommended.
Danish: Samtidig administration af sofosbuvir/velpatasvir og regimer indeholdende efavirenz frarådes.
English: Metabolism and nutrition disorders Very common hypophosphataemia1
Danish: Metabolisme og ernæring Meget almindelig:
English: • If you take Emtricitabine/Tenofovir disoproxil Zentiva for treatment of HIV infection, stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Danish: • Hvis du tager Emtricitabine/Tenofovir disoproxil Zentiva for behandling af HIV-infektion, kan det nedsætte effektiviteten af den behandling mod HIV, som din læge anbefaler, hvis du stopper med at tage tabletterne.
English: In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Zscore was -1.004 and -0.809, and mean total body BMD Z-score was -0.866 and -0.584, respectively, at baseline.
Danish: Hos patienter, der fik tenofovirdisoproxil eller placebo, var den gennemsnitlige BMD Z-score i lænderygsøjlen -1,004 og -0,809, og den gennemsnitlige BMD Z-score i hele kroppen var henholdsvis -0,866 og -0,584 ved baseline.
English: Uncommon angioedema3
Danish: angioødem3
English: Emtricitabine/Tenofovir disoproxil Zentiva should not be given to adolescents with existing kidney problems.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva bør ikke anvendes til unge med eksisterende nyreproblemer.
English: Adults with renal impairment
Danish: Voksne med nedsat nyrefunktion:
English: Patients receiving ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir concomitantly with tenofovir disoproxil and a boosted HIV protease inhibitor should be monitored for adverse reactions related to tenofovir disoproxil.
Danish: Patienter, der får ledipasvir/sofosbuvir, sofosbuvir/velpatasvir eller sofosbuvir/velpatasvir/voxilaprevir sammen med tenofovirdisoproxil og en boostet HIV-proteasehæmmer, bør overvåges for bivirkninger relateret til tenofovirdisoproxil.
English: Table 7: Efficacy and adherence in study CO-US-104-0288 (iPrEx, matched case-control analysis)
Danish: Tabel 7: Virkning og adhærens i studie CO-US-104-0288 (iPrEx, matchet case kontrolanalyse)
English: The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 12 years have not been established.
Danish: Sikkerheden og virkningen af emtricitabin/tenofovirdisoproxil hos børn og unge under 12 år -er ikke klarlagt.
English: • cidofovir (for viral infection).
Danish: • cidofovir (mod virusinfektion)
English: • If you are taking Emtricitabine/Tenofovir disoproxil Zentiva to reduce the risk of getting HIV, take Emtricitabine/Tenofovir disoproxil Zentiva every day, not just when you think you have been at risk of HIV infection.
Danish: • Hvis du tager Emtricitabine/Tenofovir disoproxil Zentiva for at nedsætte risikoen for at få HIV, skal du tage Emtricitabine/Tenofovir disoproxil Zentiva hver dag og ikke kun, når du mener, at du har været udsat for at blive smittet med HIV.
English: 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.
Danish: Tenofovirs gennemsnitlige (% variationskoefficient) Cmax- og AUC0 - ∞-værdier var henholdsvis 223 (34,8%) ng/ml og 2.050 (50,8%) ng·t/ml hos forsøgspersoner med normal leverfunktion sammenlignet med 289 (46,0%) ng/ml og 2.310 (43,5%) ng·t/ml hos forsøgspersoner med moderat nedsat leverfunktion og 305 (24,8%) ng/ml og 2.740 (44,0%) ng·t/ml hos forsøgspersoner med svært nedsat leverfunktion.
English: • Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day,
Danish: • Unge i alderen 12 år til under 18 år, som vejer mindst 35 kg: En tablet om dagen, så vidt muligt sammen med mad.
English: • Know your hepatitis B virus (HBV) infection status before starting Emtricitabine/Tenofovir disoproxil Zentiva.
Danish: • Kend din status for hepatitis B virus (HBV)-infektion, inden du begynder at tage
English: The potential renal and bone effects with long-term use of emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis in adolescents are unknown (see section 4.4).
Danish: De potentielle virkninger på nyrer og knogler ved langtidsbrug af emtricitabin/tenofovirdisoproxil til profylakse før eksponering hos voksne er ukendt (se pkt.
English: Renal and urinary disorders Uncommon increased creatinine, proteinuria, proximal renal tubulopathy including Fanconi syndrome
Danish: øget kreatinin, proteinuri, proksimal renal tubulopati, herunder Fanconis syndrom
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/Tenofovir disoproxil Zentiva use.
Danish: Hvis nyreabnormiteter mistænkes eller påvises, bør der tages kontakt til en nefrolog med henblik på at overveje, om brugen af Emtricitabine/Tenofovir disoproxil Zentiva skal afbrydes.
English: • pain, stomach pain,
Danish: • smerter, mavesmerter
English: Do not stop taking Emtricitabine/Tenofovir disoproxil Zentiva
Danish: Hold ikke op med at tage Emtricitabine/Tenofovir disoproxil Zentiva
English: 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 subjects with mild, moderate and severe renal impairment, respectively.
Danish: Den gennemsnitlige (% variationskoefficient) emtricitabineksponering steg fra 12 (25%) μg·t/ml hos forsøgspersoner med normal nyrefunktion til 20 (6%) μg·t/ml, 25 (23%) μg·t/ml og 34 (6%) μg·t/ml hos forsøgspersoner med henholdsvis let, moderat og svært nedsat nyrefunktion.
English: Mild renal impairment (CrCl 50-80 ml/min)
Danish: Let nedsat nyrefunktion (CrCl 50-80 ml/min)
English: Emtricitabine/ tenofovir disoproxil (n = 1,579)
Danish: Emtricitabin/ tenofovirdisoproxil (n = 1.579)
English: A decreased dosage of 250 mg didanosine coadministered with tenofovir disoproxil therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Danish: I forbindelse med en reduceret dosis på 250 mg didanosin administreret samtidig med tenofovirdisoproxil er der blevet rapporteret om en høj forekomst af manglende virologisk virkning af flere testede kombinationer til behandling af HIV 1-infektion.
English: Adherence Substudy
Danish: Adhærensdelstudie
English: 35 kg, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects.
Danish: • Det bruges også til at behandle HIV hos unge i alderen fra 12 til under 18 år, som vejer mindst 35 kg, og som allerede er blevet behandlet med andre HIV-lægemidler, som ikke længere er effektive, eller som har forårsaget bivirkninger.
English: Common vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)2
Danish: vesikulobulløst udslæt, pustuløst udslæt, makulopapuløst udslæt, udslæt, pruritus, urticaria, misfarvning af huden (øget pigmentering)2
English: Emtricitabine/Tenofovir disoproxil Zentiva can cause dizziness.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva kan forårsage svimmelhed.
English: • vomiting or diarrhoea
Danish: • diarré, opkastning, kvalme
English: • The active substances are emtricitabine and tenofovir disoproxil phosphate.
Danish: • Aktive stoffer: emtricitabin og tenofovirdisoproxilphosphat.
English: Emtricitabine/Tenofovir disoproxil Zentiva is not always effective in preventing the acquisition of HIV-1.
Danish: Generel strategi til forebyggelse af HIV 1-infektion Emtricitabine/Tenofovir disoproxil Zentiva er ikke altid effektivt med hensyn til at forebygge smitte med HIV 1.
English: • ganciclovir (for viral infection).
Danish: • ganciclovir (mod virusinfektion)
English: Emtricitabine/tenofovir disoproxil has not been studied in individuals over the age of 65 years.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva er ikke blevet undersøgt hos personer over 65 år.
English: Atazanavir/ritonavir/emtricitabine Interaction not studied.
Danish: Atazanavir/Ritonavir/Emtricitabin Interaktion er ikke undersøgt.
English: Other medicines and Emtricitabine/Tenofovir disoproxil Zentiva Do not take Emtricitabine/Tenofovir disoproxil Zentiva if you are already taking other medicines that contain the components of Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Danish: Brug af anden medicin sammen med Emtricitabine/Tenofovir disoproxil Zentiva Tag ikke Emtricitabine/Tenofovir disoproxil Zentiva, hvis du allerede tager anden medicin som indeholder indholdsstofferne i Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabin og tenofovirdisoproxil) eller antiviral medicin, som indeholder tenofoviralafenamid, lamivudin eller adefovirdipivoxil.
English: Film-coated tablet
Danish: Filmovertrukne-tabletter
English: If vomiting occurs within 1 hour of taking Emtricitabine/Tenofovir disoproxil Zentiva, another tablet should be taken.
Danish: Hvis patienten kaster op inden for 1 time efter at have taget Emtricitabine/Tenofovir disoproxil Zentiva, skal der tages en ny tablet.
English: If Emtricitabine/Tenofovir disoproxil Zentiva is coadministered with an NSAID, renal function should be monitored adequately.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva administreres samtidig med et NSAID, skal nyrefunktionen monitoreres med passende intervaller.
English: • If you notice within 12 hours of the time you usually take Emtricitabine/Tenofovir disoproxil Zentiva, take the tablet preferably with food as soon as possible.
Danish: • Hvis du kommer i tanke om en glemt dosis inden for 12 timer efter det tidspunkt, hvor du normalt tager Emtricitabine/Tenofovir disoproxil Zentiva, er det bedst, at du tager tabletten med mad så hurtigt som muligt.
English: Furthermore, in a small clinical study, a subgroup of patients with creatinine clearance between 50 and 60 ml/min who received tenofovir disoproxil 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).
Danish: I et lille klinisk studie havde en undergruppe af patienter med kreatininclearance mellem 50 og 60 ml/min, som fik tenofovirdisoproxil i kombination med emtricitabin en gang i døgnet, 2−4 gange højere eksponering for tenofovir og forværring af nyrefunktionen (se pkt.
English: Emtricitabine/Tenofovir disoproxil Zentiva should not be administered concomitantly with adefovir dipivoxil.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva bør ikke administreres samtidig med adefovirdipivoxil.
English: Whenever possible, Emtricitabine/Tenofovir disoproxil Zentiva should be taken with food.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva skal så vidt muligt tages sammen med mad.
English: If you forget to take Emtricitabine /Tenofovir disoproxil Zentiva
Danish: Hvis du har glemt at tage Emtricitabine/Tenofovir disoproxil Zentiva
English: Stopping use of Emtricitabine/Tenofovir disoproxil Zentiva, or missing doses, may increase your risk of getting HIV infection.
Danish: Hvis du stopper med at tage Emtricitabine/Tenofovir disoproxil Zentiva eller springer en dosis over, kan det øge din risiko for at blive smittet med HIV.
English: Emtricitabine/tenofovir disoproxil has not been studied in HIV-1 uninfected individuals with creatinine clearance < 60 ml/min and is therefore not recommended for use in this population.
Danish: Håndtering af nedsat nyrefunktion ved profylakse før eksponering Emtricitabin/tenofovirdisoproxil er ikke blevet undersøgt hos personer uden HIV 1-infektion med kreatininclearance f60 ml/min og anbefales derfor ikke til denne population.
English: As emtricitabine / tenofovir disoproxil may cause renal damage monitoring of renal function is recommended (see section 4.4).
Danish: Da emtricitabin/tenofovirdisoproxil kan forårsage nyreskader, anbefales monitorering af nyrefunktionen (se pkt.
English: Outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 3 bottles of 30 film-coated tablets.
Danish: Pakningsstørrelser: Pakning med 1 tabletbeholder med 30 filmovertrukne tabletter og pakning med 3 tabletbeholdere med hver 30 filmovertrukne tabletter.
English: It is preferable that Emtricitabine/Tenofovir disoproxil Zentiva is taken with food.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva skal helst tages sammen med mad.
English: (for treatment of HIV infection): Taking Emtricitabine/Tenofovir disoproxil Zentiva with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Danish: Indtagelse af Emtricitabine/Tenofovir disoproxil Zentiva sammen med medicin som indeholder didanosin (til behandling af HIV-infektion): Hvis du tager Emtricitabine/Tenofovir disoproxil Zentiva sammen med antiviral medicin, som indeholder didanosin, kan det øge indholdet af didanosin i blodet og reducere CD4-celletallet.
English: ANTI-INFECTIVES Hepatitis B virus (HBV) antiviral agents Adefovir dipivoxil /tenofovir disoproxil
Danish: Hepatitis B-virus (HBV) antivirale midler Adefovirdipivoxil/Tenofovirdisop roxil
English: In the iPrEx clinical study, no HIV-1 variants expressing K65R, K70E, M184V, or M184I were detected at the time of seroconversion among subjects who became infected with HIV-1 after enrollment in the study.
Danish: I det kliniske iPrExstudie blev der ikke registreret HIV 1-varianter, som eksprimerede K65R, K70E, M184V eller M184I på tidspunktet for serokonvertering, blandt forsøgspersoner, som blev inficeret med HIV 1 efter optagelse i studiet.
English: • fever
Danish: • fedtlever
English: • foscarnet (for viral infection).
Danish: • foscarnet (mod virusinfektion)
English: • Provides information on how to take Emtricitabine/Tenofovir disoproxil Zentiva
Danish: • Give oplysninger om, hvordan Emtricitabine/Tenofovir disoproxil Zentiva tages
English: Emtricitabine and tenofovir are eliminated by renal excretion and the exposure to emtricitabine and tenofovir increases in individuals with renal dysfunction (see sections 4.4 and 5.2).
Danish: Emtricitabin og tenofovir udskilles via nyrerne, og eksponeringen for emtricitabin og tenofovir øges hos personer med nedsat nyrefunktion (se pkt.
English: Paediatrics with renal impairment Not recommended for use in individuals under the age of 18 years with renal impairment (see section
Danish: Pædiatriske patienter med nedsat nyrefunktion: Frarådes hos -personer under 18 år med nedsat nyrefunktion (se pkt.
English: The recommended dose of Emtricitabine/Tenofovir disoproxil Zentiva to treat HIV is:
Danish: Den anbefalede dosis Emtricitabine/Tenofovir disoproxil Zentiva til behandling af HIV er:
English: Antimycobacterials Rifampicin/tenofovir disoproxil
Danish: Antimykobakterielle midler Rifampicin/Tenofovirdisoproxil
English: Sofosbuvir: AUC: ↔
Danish: Ritonavir: AUC: ↔
English: • dizziness, headache,
Danish: • svimmelhed, hovedpine
English: In infants and children older than 4 months, the majority of patients taking emtricitabine achieved or maintained complete suppression of plasma HIV-1 RNA through 48 weeks (89% achieved ≤ 400 copies/ml and 77% achieved ≤ 50 copies/mL).
Danish: Hos spædbørn og børn over 4 måneder opnåede eller bevarede størstedelen af de patienter, der fik emtricitabin, fuldstændig suppression af HIV-1 RNA i plasma igennem 48 uger (89%