FrancophonIA/ELRC3.0 huggingface dataset:
English: Emtricitabine/Tenofovir disoproxil Mylan with food and drink
Danish: Brug af Emtricitabine/Tenofovir disoproxil Mylan sammen med mad og drikke
English: Renal management in HIV-1 infected patients
Danish: Håndtering af nedsat nyrefunktion hos HIV 1-inficerede patienter
English: • pain, stomach pain
Danish: • smerter, mavesmerter
English: Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).
Danish: Knogleabnormiteter (der i sjældne tilfælde bidrager til frakturer) kan være forbundet med proksimal renal tubulopati (se pkt.
English: • aminoglycosides (for bacterial infection)
Danish: • aminoglykosider (mod bakterie-infektion)
English: Mean changes at week 48 (end of double-blind phase) were -0.215 and -0.165 in lumbar spine BMD Z-score, and -0.254 and -0.179 in total body BMD Z-score for the tenofovir disoproxil and placebo groups, respectively.
Danish: De gennemsnitlige ændringer i BMD Z-score i uge 48 (afslutningen på den dobbeltblinde fase) var -0,215 og -0,165 i lænderygsøjlen og -0,254 og -0,179 i hele kroppen for henholdsvis tenofovirdisoproxil og placebo.
English: Not recommended for use in individuals under the age of 18 years with renal impairment (see section 4.4).
Danish: Frarådes hos personer under 18 år med nedsat nyrefunktion (se pkt.
English: A decreased dosage of 250 mg didanosine co-administered 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 effekt af flere testede kombinationer til behandling af HIV 1-infektion.
English: Emtricitabine/tenofovir disoproxil has not been studied in patients over 65 years of age.
Danish: Emtricitabin/tenofovirdisoproxil er ikke blevet undersøgt hos patienter over 65 år.
English: • If you notice within 12 hours of the time you usually take Emtricitabine/Tenofovir disoproxil Mylan, take the tablet preferably with food as soon as possible.
Danish: • Hvis De kommer i tanke om en glemt dosis inden for 12 timer efter det tidspunkt, hvor De normalt tager Emtricitabine/Tenofovir disoproxil Mylan, er det bedst, at De tager tabletten med mad så hurtigt som muligt.
English: (may affect up to 1 in 100 people)
Danish: (kan opstå hos op til 1 ud af 100 personer)
English: Hepatitis B virus (HBV) antiviral agents
Danish: Hepatitis B-virus (HBV) antivirale midler Adefovirdipivoxil/
English: If overdose occurs the individual must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
Danish: I tilfælde af overdosering skal personen monitoreres for tegn på toksicitet (se pkt.
English: No dose adjustment of efavirenz is required.
Danish: Dosisjustering af efavirenz er ikke nødvendig.
English: In HIV 1 infected children (aged 2 to 15 years), the BMD Z scores observed in subjects who switched to tenofovir disoproxil were lower than those observed in subjects who remained on their stavudine- or zidovudine-containing regimen (see sections 4.4 and 5.1).
Danish: Hos HIV 1-inficerede børn (2-15 år) var de observerede BMD Z-scorer hos de forsøgspersoner, der skiftede til tenofovirdisoproxil, lavere end hos de forsøgspersoner, der fortsatte med et regime indeholdende stavudin eller zidovudin (se pkt.
English: angioedema
Danish: angioødem
English: Interrupting use of emtricitabine/tenofovir disoproxil should also be considered in case of progressive decline of renal function when no other cause has been identified.
Danish: Afbrydelse af brugen af Emtricitabine/Tenofovir disoproxil Mylan bør også overvejes i tilfælde af progredierende nedsat nyrefunktion, når ingen anden årsag er blevet påvist.
English: Studies with tenofovir disoproxil
Danish: Studier med tenofovirdisoproxil
English: The combination should be used with caution with frequent renal monitoring (see section 4.4).
Danish: Kombinationen skal anvendes med forsigtighed og med hyppig monitorering af nyrefunktionen (se pkt.
English: Use with ledipasvir and sofosbuvir, sofosbuvir and velpatasvir or sofosbuvir, velpatasvir and voxilaprevir
Danish: Brug med ledipasvir og sofosbuvir, sofosbuvir og velpatasvir eller sofosbuvir, velpatasvir og voxilaprevir
English: • cidofovir (for viral infection)
Danish: • cidofovir (mod virusinfektion)
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 sofosvubir/velpatasvir/voxilaprevir sammen med tenofovirdisoproxil og en boostet HIV-proteasehæmmer, bør overvåges for bivirkninger relateret til tenofovirdisoproxil.
English: • vancomycin (for bacterial infection)
Danish: • vancomycin (mod bakterie-infektion)
English: No dose adjustment is recommended.
Danish: Der er ingen anbefalet dosisjustering.
English: Emtricitabine
Danish: Emtricitabin
English: EU/1/16/1133/002
Danish: EU/1/16/1133/005 EU/1/16/1133/006
English: The pharmacokinetics of emtricitabine and tenofovir (administered as tenofovir disoproxil) in paediatric patients with renal impairment have not been studied.
Danish: Farmakokinetikken af emtricitabin og tenofovir (administreret som tenofovirdisoproxil) er ikke undersøgt hos pædiatriske patienter med nedsat nyrefunktion.
English: Renal impairment: As emtricitabine/tenofovir disoproxil may cause renal damage, monitoring of renal function is recommended (see section 4.4).
Danish: Nedsat nyrefunktion: Da emtricitabin/tenofovirdisoproxil kan foråsage nyreskader, anbefales monitorering af nyrefunktionen (se pkt.
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: • HIV paediatric renal educational brochure
Danish: • Undervisningsbrochure om HIV og nyrefunktion hos pædiatriske patienter
English: Cmax: ↓ 30% (↓ 41 to ↓ 17) Cmin: ↑ 63% (↑ 43 to ↑ 85)
Danish: Cmax: ↓ 30% (↓ 41 til ↓ 17) Cmin: ↑ 63% (↑ 43 til ↑ 85)
English: Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Danish: Det er vist, at samtidig administration af tenofovirdisoproxil og ledipasvir/sofosbuvir, sofosbuvir/velpatasvir eller sofosbuvir/velpatasvir/voxilaprevir øger plasmakoncentrationen af tenofovir, især når de anvendes sammen med et HIV-regime, der indeholder tenofovirdisoproxil og en farmakokinetisk forstærker (ritonavir eller cobicistat).
English: Renal management in PrEP:
Danish: Håndtering af nedsat nyrefunktion ved PrEP:
English: The adverse reactions observed in paediatric patients who received treatment with tenofovir disoproxil were consistent with those observed in clinical studies of tenofovir disoproxil in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Danish: De bivirkninger, der blev observeret hos pædiatriske patienter, som fik tenofovirdisoproxil, svarede til dem, der blev observeret i kliniske studier af tenofovirdisoproxil hos voksne (se pkt.
English: Signs of osteonecrosis are:
Danish: Tegn på knoglenekrose er:
English: Mild renal impairment (CrCl 50-80 mL/min)
Danish: Let nedsat nyrefunktion (CrCl 50-80 ml/min)
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 enrolment in the study.
Danish: I det kliniske iPrEx-studie 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: The recommended dose of Emtricitabine/Tenofovir disoproxil Mylan to treat HIV is:
Danish: Den anbefalede dosis af Emtricitabine/Tenofovir disoproxil Mylan til behandling af HIV er:
English: Co-administration of sofosbuvir/velpatasvir with efavirenzcontaining regimens is not recommended.
Danish: Samtidig administration af sofosbuvir/velpatasvir og regimer indeholdende efavirenz frarådes.
English: Emtricitabine/tenofovir disoproxil can cause dizziness.
Danish: Emtricitabin/tenofovirdisoproxil kan forårsage svimmelhed.
English: Cmin: ↑ 91% (↑ 74 to ↑ 110)
Danish: Cmin: ↑ 91% (↑ 74 til ↑ 110)
English: Renal impairment: 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: Nedsat nyrefunktion: Emtricitabin og tenofovir udskilles via nyrerne, og eksponeringen for emtricitabin og tenofovir øges hos personer med nedsat nyrefunktion (se pkt.
English: The effectiveness of Emtricitabine/tenofovir disoproxil in reducing the risk of acquiring HIV-1 is strongly correlated with adherence as demonstrated by measurable drug levels in blood (see section 5.1).
Danish: Der er en stærk korrelation mellem emtricitabin/tenofovirdisoproxil-behandlingens effektivitet med hensyn til at reducere risikoen for at få HIV 1 og adhærens påvist ved målbare lægemiddelniveauer i blodet (se pkt.
English: • yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver
Danish: • gulfarvning af hud eller øjne, kløe eller mavesmerter på grund af leverbetændelse
English: The pharmacokinetics of emtricitabine has not been studied in patients with hepatic impairment.
Danish: Farmakokinetikken af emtricitabin er ikke undersøgt hos patienter med nedsat leverfunktion.
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: rhabdomyolysis1, muscular weakness1
Danish: rabdomyolyse1, muskelsvækkelse1
English: Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least35 kg: One tablet,
Danish: Forebyggelse af HIV hos voksne og unge i alderen 12 år og derover, der vejer mindst 35 kg: En tablet en gang dagligt.
English: Possible side effects: Very common side effects
Danish: Meget almindelige bivirkninger
English: PrEP reminder card for the individual at risk (to be provided by HCP):
Danish: PrEP-huskekort til den udsatte person (skal udleveres af læge/sundhedspersonale):
English: • ganciclovir (for viral infection)
Danish: • ganciclovir (mod virusinfektion)
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: Total body bone gain was less in the tenofovir disoproxil treatment group compared to the stavudine or zidovudine treatment group.
Danish: BMD-stigningen i hele kroppen var mindre i gruppen, der fik tenofovirdisoproxil, sammenlignet med gruppen, der fik stavudin eller zidovudin.
English: 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: (see section 4, Possible side effects).
Danish: 4.8, Tabel over bivirkninger).
English: AUC: ↓ 53% (↓ 61 to ↓ 43) Cmax: ↓ 47% (↓ 57 to ↓ 36) Cmin: ↓ 57% (↓ 64 to ↓ 48)
Danish: AUC: ↓ 53% (↓ 61 til ↓ 43) Cmax: ↓ 47% (↓ 57 til ↓ 36) Cmin: ↓ 57% (↓ 64 til ↓ 48)
English: Interrupting treatment with emtricitabine/tenofovir disoproxil should also be considered in case of progressive decline of renal function when no other cause has been identified.
Danish: Det bør også overvejes at afbryde behandlingen med emtricitabin/tenofovirdisoproxil i tilfælde af progredierende fald i nyrefunktionen, når ingen anden årsag er blevet identificeret.
English: • dizziness, headache
Danish: • svimmelhed, hovedpine
English: Emtricitabine/tenofovir disoproxil should not be administered concomitantly with adefovir dipivoxil.
Danish: Emtricitabin/tenofovirdisoproxil bør ikke indgives samtidig med adefovirdipivoxil.
English: NAME OF THE MARKETING AUTHORISATION HOLDER MYLAN S.A.S
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN MYLAN S.A.S
English: Antimycobacterials Rifampicin /Tenofovir disoproxil
Danish: Antimykobakterielle midler Rifampicin/Tenofovirdisoproxil
English: Table 6: Efficacy in study CO-US-104-0288 (iPrEx)
Danish: Tabel 6: Effekt i studie CO-US-104-0288 (iPrEx)
English: Cohort
Danish: Kohorte
English: Emtricitabine/Tenofovir disoproxil Mylan is indicated in combination with safer sex practices for preexposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).
Danish: Emtricitabine/Tenofovir disoproxil Mylan er i kombination med god praksis for sikker sex indiceret som profylakse før eksponering for at mindske risikoen for seksuelt erhvervet HIV 1-infektion hos meget udsatte voksne og unge (se pkt.
English: If renal abnormalities are detected or suspected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/Tenofovir disoproxil Mylan treatment
Danish: Hvis nyreabnormiteter mistænkes eller påvises, bør der tages kontakt til en nefrolog med henblik på at overveje at afbryde behandlingen med Emtricitabine/Tenofovir disoproxil Mylan
English: Paediatrics with renal impairment:
Danish: Pædiatriske patienter med nedsat nyrefunktion:
English: • foscarnet (for viral infection)
Danish: • foscarnet (mod virusinfektion)
English: AUC: ↓ 12% (↓ 16 to ↓ 8) Cmax: ↓ 16% (↓ 22 to ↓ 10) Cmin: ↓ 15% (↓ 12 to ↓ 9)
Danish: AUC: ↓ 12% (↓ 16 til ↓ 8) Cmax: ↓ 16% (↓ 22 til ↓ 10) Cmin: ↓ 15% (↓ 12 til ↓ 9)
English: Hepatic impairment
Danish: hovedpine svimmelhed
English: Contains: lactose monohydrate.
Danish: Indeholder: lactosemonohydrat.
English: These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings.
Danish: Mitokondriel dysfunktion bør overvejes hos alle børn med svære kliniske symptomer af ukendt ætiologi, især neurologiske symptomer, der har været eksponeret for nukleosid-/nukleotidanaloger in utero.
English: If you vomit less than 1 hour after taking Emtricitabine/Tenofovir disoproxil Mylan, take another tablet.
Danish: Hvis De kaster op mindre end en time efter, De har taget Emtricitabine/Tenofovir disoproxil Mylan, skal De tage en ny tablet.
English: Emtricitabine+ tenofovir disoproxil +efavirenz*
Danish: Emtricitabin+ tenofovirdisoproxil+efavirenz*
English: Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor.
Danish: Emtricitabin hører til en gruppe lægemidler, der kaldes nukleosid-revers transkriptase-hæmmere, og tenofovir hører til en gruppe, der kaldes nukleotid-revers transkriptase hæmmere.
English: Emtricitabine/tenofovir disoproxil has not been studied in individuals over the age of 65 years.
Danish: Emtricitabin/tenofovirdisoproxil er ikke blevet undersøgt hos personer over 65 år.
English: Drug Detected
Danish: Lægemiddel Detekteret
English: The mean rate of lumbar spine bone gain at week 48 was similar between the tenofovir disoproxil treatment group and the stavudine or zidovudine treatment group.
Danish: Gennemsnitligt var BMD-stigningen i lænderygsøjlen i uge 48 ens i gruppen, der fik tenofovirdisoproxil, og gruppen, der fik stavudin eller zidovudin.
English: CARTON (FOR BLISTERS AND BOTTLE)
Danish: PAKNING (TIL BLISTERPAKNINGER OG TABLETHOLDERE) 1.
English: In the Partners PrEP 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 during the study.
Danish: I det kliniske Partners PrEP-studie blev der ikke registreret HIV 1-varianter, som eksprimerede K65R, K70E, M184V eller M184I på tidspunktet for serokonvertering, blandt forsøgspersoner, der blev inficeret med HIV 1 i løbet af studiet.
English: • drowsiness
Danish: • træthed
English: • Always take this medicine exactly as your doctor has told you.
Danish: • Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Cmin: ↑ 51% (↑ 37 to ↑ 66)
Danish: Cmin: ↑ 51% (↑ 37 til ↑ 66)
English: The use of emtricitabine/tenofovir disoproxil is not recommended in individuals under the age of 18 years with renal impairment (see section 4.2).
Danish: Emtricitabine/Tenofovir disoproxil Mylan frarådes hos personer under 18 år med nedsat nyrefunktion (se pkt.
English: (may affect up to 1 in 10 people)
Danish: (kan opstå hos op til 1 ud af 10 personer)
English: Table 10: Efficacy and adherence in study CO-US-104-0380 (Partners PrEP)
Danish: Tabel 10: Effekt og adhærens i studie CO-US-104-0380 (Partners PrEP)
English: Tenofovir disoproxil should be avoided in patients with HIV-1 harbouring the K65R mutation.
Danish: Tenofovirdisoproxil bør undgås hos tidligere antiretroviral-behandlede patienter med HIV 1 med stammer, som har K65R-mutationer.
English: Do not stop taking Emtricitabine/Tenofovir disoproxil Mylan
Danish: Hold ikke op med at tage Emtricitabine/Tenofovir disoproxil Mylan
English: Cmin: ↑ 39% (↑ 20 to ↑ 61)
Danish: Cmin: ↑ 39% (↑ 20 til ↑ 61)
English: Renal effects:
Danish: Bivirkninger:
English: Emtricitabine/Tenofovir disoproxil Mylan contains lactose monohydrate.
Danish: Emtricitabine/Tenofovir disoproxil Mylan indeholder lactosemonohydrat.
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/tenofovir disoproxil 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 Mylan skal afbrydes.
English: Use of emtricitabine/tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Danish: Brug af emtricitabin/tenofovirdisoproxil bør undgås ved samtidig eller nylig brug af et nefrotoksisk lægemiddel.
English: If vomiting occurs within 1 hour of taking Emtricitabine/Tenofovir disoproxil Mylan, another tablet should be taken.
Danish: Hvis patienten kaster op inden for 1 time efter at have taget Emtricitabine/Tenofovir disoproxil Mylan, skal der tages en ny tablet.
English: The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 12 years have not been established.
Danish: Pædiatrisk population Sikkerheden og virkningen af emtricitabin/tenofovirdisoproxil hos børn under 12 år er ikke klarlagt.
English: If a dose of emtricitabine/tenofovir disoproxil is missed within 12 hours of the time it is usually taken, emtricitabine/tenofovir disoproxil should be taken as soon as possible and the normal dosing schedule should be resumed.
Danish: Hvis en patient glemmer at tage en dosis emtricitabin/tenofovirdisoproxil i 12 timer efter tidspunktet, hvor dosen normalt skulle tages, skal patienten tage emtricitabin/tenofovirdisoproxil sammen med mad så snart som muligt og derefter fortsætte i henhold til den normale doseringsplan.
English: The mean (%CV) tenofovir drug exposure increased from 2,185 (12%) ng•h/mL in subjects 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 subjects with mild, moderate and severe renal impairment, respectively.
Danish: Den gennemsnitlige (% variationskoefficient) tenofovireksponering steg fra 2.185 (12%) ng•t/ml hos forsøgspersoner med normal nyrefunktion til 3.064 (30%) ng•t/ml, 6.009 (42%) ng•t/ml og 15.985 (45%) ng•t/ml hos forsøgspersoner med henholdsvis let, moderat og svært nedsat nyrefunktion.
English: What you need to know before you take Emtricitabine/Tenofovir disoproxil Mylan 3.
Danish: Det skal De vide, før De begynder at tage Emtricitabine/Tenofovir disoproxil Mylan 3.
English: There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
Danish: Der er rapporteret om mitokondriel dysfunktion hos HIV-negative spædbørn, som har været eksponeret for nukleosidanaloger in utero og/eller postnatalt.
English: once daily.
Danish: 2 år.
English: AUC: ↓ 29% (↓ 36 to ↓ 22) Cmax: ↓ 41% (↓ 51 to ↓ 29)
Danish: AUC: ↓ 29% (↓ 36 til ↓ 22) Cmax: ↓ 41% (↓ 51 til ↓ 29)
English: The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 12 years have not been established (see section 5.2).
Danish: Emtricitabin/tenofovirdisoproxils sikkerhed og virkning hos børn og unge under 12 år er ikke klarlagt (se pkt.
English: • Take this medicine every day to reduce your risk, not just when you think you have been at risk of HIV infection.
Danish: • Tag Emtricitabine/Tenofovir disoproxil Mylan hver dag for at reducere Deres risiko, ikke kun når De mener, at De har været udsat at få for HIV-infektion.
English: The safety of tenofovir disoproxil when co-administered with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
Danish: Sikkerheden af tenofovirdisoproxil ved administration sammen med ledipasvir/sofosbuvir, sofosbuvir/velpatasvir eller sofosvubir/velpatasvir/voxilaprevir og en farmakokinetisk forstærker er ikke klarlagt.
English: Therefore, emtricitabine/tenofovir disoproxil should not be used during breast-feeding.
Danish: emtricitabin/tenofovirdisoproxil bør derfor ikke anvendes under amning.
English: dizziness headache
Danish: svimmelhed hovedpine
English: • rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches
Danish: • udslæt (inklusive røde pletter eller skjolder, undertiden med blærer eller hævelse af huden),
English: If you forget to take Emtricitabine/Tenofovir disoproxil Mylan
Danish: Hvis De har glemt at tage Emtricitabine/Tenofovir disoproxil Mylan
English: NAME OF THE MEDICINAL PRODUCT Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg filmovertrukne tabletter
English: Cmax: ↑ 38% (↑ 14 to ↑ 67)
Danish: Cmax: ↑ 38% (↑ 14 til ↑ 67)
English: Osteonecrosis
Danish: Osteonekrose
English: Treatment of HIV-1 infection in the paediatric population There are no clinical studies conducted with emtricitabine/tenofovir disoproxil in the paediatric population with HIV-1 infection.
Danish: Der er ikke udført kliniske studier med emtricitabin/tenofovirdisoproxil hos den pædiatriske population med HIV 1-infektion.