FrancophonIA/ELRC3.0 huggingface dataset:
English: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any patient with renal impairment treated with Eviplera (see sections 4.2, 4.4 and 5.2).
Danish: Da tenofovirdisoproxil kan forårsage nyretoksicitet, anbefales tæt monitorering af nyrefunktionen hos alle patienter med nedsat nyrefunktion, som behandles med Eviplera (se pkt.
English: Maraviroc/Rilpivirine
Danish: Maraviroc/Rilpivirin
English: hepatitis3, hepatic steatosis3
Danish: hepatitis3, steatosis hepatis3 Hud og subkutane væv Meget almindelig:
English: In the week 96 pooled resistance analysis for patients receiving emtricitabine/tenofovir disoproxil + rilpivirine hydrochloride in the Phase III clinical studies C209 and C215, there were 78 virologic failure patients with genotypic resistance information available for 71 of those patients.
Danish: I den samlede resistensanalyse af de kliniske fase III-studier C209 og C215 ved uge 96 af patienter, der fik emtricitabin/tenofovirdisoproxil + rilpivirinhydrochlorid, var der 78 patienter med virologisk svigt, hvor information om genotype-resistens var tilgængelig for 71.
English: • Tenofovir disoproxil, a nucleotide reverse transcriptase inhibitor (NtRTI).
Danish: • Tenofovirdisoproxil, en nukleotid revers transkriptasehæmmer (NtRTI).
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg + 100 mg once daily)5/ Rilpivirine/Emtricitabine (25 mg/200 mg once daily)6
Danish: Sofosbuvir/velpatasvir/voxilaprevir (400 mg/100 mg/100 mg + 100 mg én gang dagligt)5/Rilpivirin/emtricitabin (25 mg/200 mg én gang dagligt)6
English: Monitoring of renal function is recommended for patients receiving Eviplera (see section 4.4).
Danish: Nyrefunktionen bør monitoreres hos patienter, som får Eviplera (se pkt.
English: Package leaflet: Information for the user Eviplera 200 mg/25 mg/245 mg film-coated tablets emtricitabine/rilpivirine/tenofovir disoproxil
Danish: Indlægsseddel: Information til brugeren Eviplera 200 mg/25 mg/245 mg filmovertrukne tabletter emtricitabin/rilpivirin/tenofovirdisoproxil
English: Antifungals Ketoconazole/Emtricitabine
Danish: Antimykotika Ketoconazol/Emtricitabin
English: BOTTLE AND CARTON LABELLING
Danish: ETIKETTERING PÅ TABLETBEHOLDER OG KARTON
English: Tenofovir displayed antiviral activity in cell culture against HIV-1 subtype A, B, C, D, E, F, G, and O (EC50 values ranged from 0.5 to 2.2 µM) and strain specific activity against HIV-2 (EC50 values ranged from 1.6 to 5.5 µM).
Danish: Tenofovir udviste antiviral aktivitet i cellekultur mod hiv 1 undertyper A, B, C, D, E, F, G og O (EC50-værdier var i intervallet fra 0,5 til 2,2 µM) og stammespecifik aktivitet mod hiv 2 (EC50-værdier var i intervallet fra 1,6 til 5,5 µM).
English: Darunavir (800 mg once daily)/ Ritonavir (100 mg once daily)/ Rilpivirine1
Danish: Darunavir (800 mg én gang dagligt)/Ritonavir (100 mg én gang dagligt)/Rilpivirin1
English: Non-clinical data on rilpivirine hydrochloride reveal no special hazard for humans based on studies of safety pharmacology, drug disposition, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Danish: Prækliniske data for rilpivirinhydrochlorid viser ingen speciel risiko for mennesker vurderet ud fra studier af sikkerhedsfarmakologi, lægemiddeldisposition, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Very common: increased pancreatic amylase2, vomiting1, 2, 3, diarrhoea1, 3, nausea1, 2, 3
Danish: forhøjet pancreasamylase2, opkastning1, 2, 3, diarré1, 3, kvalme1, 2, 3
English: angioedema1, 3, 6, severe skin reactions with systemic symptoms7 Musculoskeletal and connective tissue disorders Very common: elevated creatine kinase1
Danish: Ikke almindelig: angioødem1, 3, 6, alvorlige hudreaktioner med systemiske symptomer7 Knogler, led, muskler og bindevæv
English: Interaction not studied with any of the components of Eviplera.
Danish: Interaktion er ikke undersøgt med nogen af komponenterne fra Eviplera.
English: Emtricitabine displayed antiviral activity in cell culture against HIV-1 subtype A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 µM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 µM).
Danish: Emtricitabin viste antiviral aktivitet i cellekultur mod hiv 1 undertypen A, B, C, D, E, F og G (EC50-værdier var i intervallet fra 0,007 til 0,075 µM) og viste stammespecifik aktivitet mod hiv 2 (EC50-værdier var i intervallet fra 0,007 til 1,5 µM).
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Danish: Yderligere behandlingstiltag bør, hvis muligt, bygge på de kliniske tegn eller følge anbefalingerne fra Giftlinjen.
English: Treatment-naïve HIV-1 infected patients
Danish: Behandlingsnaive hiv 1-inficerede patienter
English: Co-administration of Eviplera and didanosine is not recommended (see section 4.4).
Danish: Samtidig administration af Eviplera og didanosin frarådes (se pkt.
English: Discontinuation of Eviplera therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Danish: Seponering af behandlingen med Eviplera hos hiv-inficerede patienter, der samtidig er inficeret med HBV, kan forekomme i forbindelse med svær, akut eksacerbation af hepatitis.
English: • Difficulty with movement
Danish: • Bevægelsesbesvær
English: In treatment-naïve HIV-1 infected patients
Danish: I behandlingsnaive hiv 1-inficerede patienter
English: Raltegravir/Rilpivirine
Danish: Raltegravir/Rilpivirin
English: Due to the decline in efavirenz plasma levels, the inductive effect decreased and rilpivirine concentrations started to normalise.
Danish: Induktionsvirkningen faldt, og rilpivirin-koncentrationerne begyndte at normaliseres på grund af reduktion i efavirenzplasmaniveauet.
English: Immune system disorders Common:
Danish: Nervesystemet Meget almindelig:
English: 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.
Danish: 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.
English: rhabdomyolysis3, 5, muscular weakness3, 5
Danish: Ikke almindelig: rabdomyolyse3, 5, muskelsvaghed3, 5 Sjælden:
English: pancreatitis3
Danish: Ikke almindelig: pancreatitis3
English: Rilpivirine is primarily metabolised by CYP3A Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Danish: Lægemidler, der inducerer eller hæmmer CYP3A, kan derfor påvirke clearance af rilpivirin (se pkt.
English: Two of the active substances in Eviplera (tenofovir disoproxil and emtricitabine) show some activity against hepatitis B virus.
Danish: Hvis De har hepatitis B, vil Deres læge nøje overveje den bedste behandling til Dem. To af de aktive stoffer i Eviplera (tenofovirdisoproxil og emtricitabin) viser nogen aktivitet mod hepatitis B-virus.
English: Rilpivirine has not been studied in patients with severe hepatic impairment (CPT Score C) (see section 4.2).
Danish: Rilpivirin er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (CPT score C) (se pkt.
English: Adverse reaction Blood and lymphatic system disorders
Danish: Hyppighed Bivirkning Blod- og lymfesystem Almindelig:
English: Eviplera has not been studied in patients with severe hepatic impairment (CPT Score C).
Danish: Eviplera er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (CPT score C).
English: (may affect more than 1 in 10 people)
Danish: (kan opstå hos mere end 1 ud af 10 personer)
English: The pharmacokinetics of rilpivirine has not been studied in patients with renal insufficiency.
Danish: Rilpivirins farmakokinetik er ikke undersøgt hos patienter med nedsat nyrefunktion.
English: Non-clinical data on tenofovir disoproxil reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Danish: Prækliniske data for tenofovirdisoproxil viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet, karcinogenicitet samt reproduktions og udviklingstoksicitet.
English: (rilpivirine) and 5/14 (efavirenz) were in patients with a baseline viral load of ≤ 100,000 copies/mL.
Danish: Af disse virologiske svigt forekom 5/15 (rilpivirin) og 5/14 (efavirenz) hos patienter med en virusbelastning på ≤ 100.000 kopier/ml ved baseline.
English: The pharmacokinetics of emtricitabine has not been studied in patients with hepatic impairment.
Danish: Emtricitabins farmakokinetik er ikke undersøgt hos patienter med nedsat leverfunktion.
English: Metformin (850 mg single dose)/ Rilpivirine
Danish: Metformin (850 mg enkeltdosis)/Rilpivirin Metformin:
English: Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Rilpivirine1 (soft capsule)
Danish: Lopinavir (400 mg to gange dagligt)/Ritonavir (100 mg to gange dagligt)/Rilpivirin1 (blød kapsel)
English: The combination of Eviplera with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Danish: Kombinationen af Eviplera og disse makrolidantibiotika kan forårsage en forhøjelse af plasmakoncentrationerne af rilpivirin (hæmmere af CYP3A-enzymer).
English: • Fatty liver
Danish: • Fedtlever
English: (mechanism of interaction unknown) Tenofovir:
Danish: (interaktionsmekanismen er ikke kendt)
English: Lopinavir/Ritonavir/Emtricitabine Interaction not studied.
Danish: Ethinylestradiol/Norethindron/Emtricitabin Interaktion er ikke undersøgt.
English: Esomeprazole2
Danish: Esomeprazol2
English: Co-administration of Eviplera with proton pump inhibitors has been observed to decrease the plasma concentrations of rilpivirine (due to an increase in gastric pH) which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3).
Danish: Det er blevet observeret, at samtidig administration af Eviplera og protonpumpehæmmere nedsætter plasmakoncentrationer af rilpivirin (pga. en stigning i pH-værdien i ventriklen), hvilket kunne medføre tab af den terapeutiske virkning af Eviplera (se pkt.
English: • Rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
Danish: • Udslæt (inklusive røde pletter eller skjolder, undertiden med blærer eller hævelse af huden), som kan være allergiske reaktioner, kløe, ændringer i hudfarven, herunder pletvis mørkfarvning af huden
English: (may affect up to 1 in 1,000 people)
Danish: (kan opstå hos op til 1 ud af 1.000 personer)
English: Digoxin/Rilpivirine
Danish: Digoxin/Rilpivirin
English: At 96 weeks in the pooled Phase III C209 and C215 studies of treatment-naïve patients, in the rilpivirine arm the mean change from baseline in total cholesterol (fasted) was 5 mg/dL, in high-density lipoprotein (HDL)-cholesterol (fasted) 4 mg/dL, in low density lipoprotein (LDL)-cholesterol (fasted) 1 mg/dL, and in triglycerides (fasted) -7 mg/dL. At 48 weeks in Phase III study GS-US-264-0106 of virologically suppressed patients switching to Eviplera from a regimen containing a ritonavir-boosted PI, the mean change from baseline in total cholesterol (fasted) was -24 mg/dL, in HDL-cholesterol (fasted) -2 mg/dL, in LDL-cholesterol (fasted) -16 mg/dL, and in triglycerides (fasted) -64 mg/dL.
Danish: I de samlede data fra fase III-studierne C209 og C215 med behandlingsnaive patienter ved uge 96 var den gennemsnitlige ændring fra baseline i total-kolesterol (fastende) 5 mg/dl, i high-density lipoprotein (HDL)-kolesterol (fastende) 4 mg/dl, i low-density lipoprotein (LDL)-kolesterol (fastende) 1 mg/dl og i triglycerider (fastende) −7 mg/dl i rilpivirin-armen.
English: Other antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg once daily)
Danish: Andre antivirale midler Ledipasvir/sofosbuvir (90 mg/400 mg én gang dagligt)/Emtricitabin/rilpivirin/ tenofovirdisoproxil (200 mg/25 mg/245 mg én gang dagligt)
English: • Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI).
Danish: • Emtricitabin, en nukleosid revers transkriptasehæmmer (NRTI).
English: Genotypic resistance testing and/or historical resistance data should guide the use of Eviplera (see sections 4.4 and 5.1).
Danish: Resistenstest for genotype og/eller historiske resistensdata skal være vejledende for anvendelsen af Eviplera (se pkt.
English: Eviplera should not be used in combination with systemic dexamethasone (except as a single dose) as co-administration may cause significant dose dependent decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Danish: Eviplera bør ikke anvendes sammen med systemisk dexamethason (undtagen som en enkeltdosis), da samtidig administration kan foråsage signifikant dosisafhængige reduktion i plasmakoncentrationen af rilpivirin (induktion af CYP3A-enzymer).
English: Norgestimate/Ethinylestradiol/ Tenofovir disoproxil
Danish: Norgestimat/Ethinylestradiol/ Tenofovirdisoproxil
English: In general, emtricitabine pharmacokinetics in HBV infected patients was similar to those in healthy subjects and in HIV infected patients.
Danish: Samtidig infektion med Hepatitis B- og/eller hepatitis C-virus Generelt lignede emtricitabins farmakokinetik hos HBV-inficerede patienter den hos raske personer og hos hiv-inficerede patienter.
English: Alternatively, switching to another antiretroviral regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).
Danish: 4.4, 4.6, 5.1 og 5.2).
English: Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate).
Danish: Hver filmovertrukken tablet indeholder 200 mg emtricitabin, 25 mg rilpivirin (som hydrochlorid) og 245 mg tenofovirdisoproxil (som fumarat).
English: When Eviplera is co-administered with rifabutin, an additional 25 mg tablet of rilpivirine per day is recommended to be taken concomitantly with Eviplera, for the duration of the rifabutin coadministration.
Danish: Eviplera indgives sammen med rifabutin, anbefales det at tage yderligere én rilpivirin-tablet på 25 mg dagligt samtidig med
English: Eviplera should not be administered concomitantly with adefovir dipivoxil (see section 4.5).
Danish: Eviplera bør ikke indgives samtidig med adefovirdipivoxil (se pkt.
English: HERBAL PRODUCTS St. John's wort (Hypericum perforatum)
Danish: NATURLÆGEMIDLER Perikon (Hypericum perforatum)
English: It is unlikely that a dose adjustment would be required for Eviplera in patients with mild or moderate hepatic impairment (see sections 4.2 and 5.2).
Danish: Det er usandsynligt, at en dosisjustering af Eviplera vil være nødvendig hos patienter med let eller moderat nedsat leverfunktion (se pkt.
English: The combination of Eviplera and H2-receptor antagonists should be used with particular caution as co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH).
Danish: Kombinationen af Eviplera og H2-receptorantagonister skal anvendes med særlig forsigtighed, da samtidig anvendelse kan forårsage signifikant reduktion i plasmakoncentrationen af rilpivirin (reduceret absorption, forhøjelse af pHværdien i ventriklen).
English: Ethinylestradiol/Norethindrone/ Tenofovir disoproxil
Danish: Ethinylestradiol/Norethindron/ Tenofovirdisoproxil
English: AUC: ↓ 10% C12h: ↓ 13% Cmax: ↓ 23%
Danish: AUC: ↓ 10 % C12t: ↓ 13 % Cmax: ↓ 23 %
English: Table 5: Virologic outcomes of randomised treatment of studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 48 (primary) and week 96
Danish: Tabel 5: Virologiske udfald af randomiseret behandling i studier C209 og C215 (samlede data for patienter, der får rilpivirinhydrochlorid eller efavirenz i kombination med emtricitabin/tenofovirdisoproxil) ved uge 48 (primært) og ved uge 96
English: Each Eviplera film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate).
Danish: Hver Eviplera filmovertrukket tablet indeholder 200 mg emtricitabin, 25 mg rilpivirin (som hydrochlorid) og 245 mg tenofovirdisoproxil (som fumarat).
English: Simeprevir (150 mg once daily)/ Rilpivirine (25 mg once daily)
Danish: Simeprevir (150 mg en gang dagligt)/rilpivirin (25 mg en gang dagligt)
English: The efficacy data from study GS-US-264-0111 (see section 5.1) indicates that the brief period of lower rilpivirine exposure does not impact antiviral efficacy of Eviplera.
Danish: 5.1) indikerer, at den korte periode med lavere rilpivirin-eksponering ikke påvirker Evipleras antivirale virkning.
English: ANTIARRHYTHMICS Digoxin/Emtricitabine
Danish: ANTIARYTMIKA Digoxin/Emtricitabin
English: c Includes patients who had HIV-1 RNA ≥ 50 copies/mL in the week 24 window, patients who discontinued early due to lack or loss of efficacy, patients who discontinued for reasons other than an adverse event (AE) or death, and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Danish: manglende virkning eller tab af virkning, patienter, som seponerede af andre årsager end bivirkninger (AE) eller død, og som på seponeringstidspunktet havde en virusbelastning ≥ 50 kopier/ml.
English: Paracetamol (500 mg single dose)/ Rilpivirine1
Danish: Paracetamol (500 mg enkeltdosis)/Rilpivirin1 Paracetamol:
English: Sofosbuvir/Tenofovir disoproxil
Danish: Sofosbuvir/ tenofovirdisoproxil
English: Table 4: Demographic and baseline characteristics of antiretroviral treatment-naïve HIV-1 infected adult patients in studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 96
Danish: Tabel 4: Demografiske og baselinekarakteristika af hiv 1-inficerede voksne patienter, som er naive med hensyn til antiretroviral behandling, og stadig er i studierne C209 og C215 (samlede data for patienter, der fik rilpivirinhydrochlorid eller efavirenz i kombination med emtricitabin/tenofovirdisoproxil) ved uge 96
English: This medicine can decrease the amount of rilpivirine (a component of Eviplera) in your blood.
Danish: Rifabutin kan nedsætte mængden af rilpivirin (et aktivt stof i Eviplera) i Deres blod.
English: • Pancreas problems
Danish: • Problemer med bugspytkirtlen
English: Rifampicin (600 mg once daily)/ Rilpivirine1
Danish: Rifampicin (600 mg én gang dagligt)/ Rilpivirin1
English: • Drowsiness
Danish: • Døsighed
English: Eviplera must not be used in combination with products containing St. John's wort as coadministration may cause significant decreases in rilpivirine plasma concentrations.
Danish: Eviplera må ikke anvendes sammen med præparater, der indeholder perikon, da samtidig administration kan forårsage signifikant reduktion i plasmakoncentrationen af rilpivirin.
English: Rilpivirine + Emtricitabine/Tenofovir disoproxil n = 550
Danish: Efavirenz + emtricitabin/ tenofovirdisoproxil n = 550
English: Atorvastatin (40 mg once daily)/ Rilpivirine1
Danish: Atorvastatin (40 mg én gang dagligt)/ Rilpivirin1
English: As Eviplera may cause renal damage, monitoring of renal function is recommended (see sections 4.4 and 4.8, Summary of the safety profile).
Danish: Da Eviplera kan foråsage nyreskader, anbefales monitorering af nyrefunktionen (se pkt.
English: The combination of Eviplera and antacids should be used with caution as co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, gastric pH increase).
Danish: Kombinationen af Eviplera og antacida bør anvendes med forsigtighed, da samtidig administration kan forårsage signifikant reduktion i plasmakoncentrationen af rilpivirin (reduceret absorption, forhøjelse af pHværdien i ventriklen).
English: Rifampicin (600 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Danish: Rifampicin (600 mg én gang dagligt)/ Tenofovirdisoproxil (245 mg én gang dagligt)
English: When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine hydrochloride were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively.
Danish: Når supraterapeutiske doser af rilpivirinhydrochlorid på 75 mg én gang dagligt og 300 mg én gang dagligt blev undersøgt hos raske voksne, var de maksimale gennemsnitstids-matchede (95 % øvre konfidensinterval) forskelle i QTcF-intervallet fra placebo efter baselinekorrektion hhv. 10,7 (15,3) og 23,3 (28,4) ms. Steady-state administration af rilpivirinhydrochlorid 75 mg én gang dagligt og 300 mg én gang dagligt resulterede i en gennemsnitlig Cmax hhv. ca. 2,6 gange og 6,7 gange højere end den gennemsnitlige steady-state Cmax, der blev observeret med den anbefalede dosis på rilpivirinhydrochlorid på 25 mg én gang dagligt.
English: Ketoconazole (400 mg once daily)/ Rilpivirine1
Danish: Ketoconazol (400 mg én gang dagligt)/ Rilpivirin1
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily)/ Emtricitabine/Rilpivirine/Tenofovir disoproxil (200 mg/25 mg/245 mg once daily)
Danish: Sofosbuvir/velpatasvir (400 mg/100 mg én gang dagligt)/ Emtricitabin/rilpivirin/tenofovirdisoproxil (200 mg/25 mg/245 mg én gang dagligt)
English: The apparent clearance of tenofovir averaged approximately 307 mL/min.
Danish: Tenofovirs tilsyneladende clearance var i gennemsnit ca.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Danish: Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af binyrebarkhormoner alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
English: Simeprevir (150 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Danish: Simeprevir (150 mg en gang dagligt)/ Tenofovirdisoproxil (245 mg en gang dagligt)
English: Table 6: Phenotypic resistance outcomes from studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 96 (based on resistance analysis)
Danish: Tabel 6: Data for fænotype-resistens fra studierne C209 og C215 (samlede data for patienter, der får rilpivirinhydrochlorid eller efavirenz i kombination med emtricitabin/tenofovirdisoproxil) ved uge 96 (baseret på resistensanalyse)
English: Sofosbuvir (400 mg once daily)/ Rilpivirine (25 mg once daily)
Danish: Sofosbuvir (400 mg én gang dagligt)/rilpivirin (25 mg én gang dagligt)
English: Sildenafil/Tenofovir disoproxil
Danish: Sildenafil/Tenofovirdisoproxil
English: Paracetamol/Tenofovir disoproxil
Danish: Paracetamol/Tenofovirdisoproxil
English: Rifabutin (300 mg once daily)/ Rilpivirine3
Danish: Rifabutin (300 mg én gang dagligt)/Rilpivirin3 Rifabutin:
English: Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
Danish: Patienter med moderat eller svært nedsat nyrefunktion kræver justering af doseringsintervallet for emtricitabin og tenofovirdisoproxil, der ikke kan opnås med kombinationstabletten (se pkt.
English: Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1
Danish: Famotidin (40 mg enkeltdosis, der tages 12 timer før rilpivirin)/Rilpivirin1
English: neutropenia1, decreased white blood cell count2, decreased haemoglobin2, decreased platelet count2
Danish: neutropeni1, nedsat leukocyttal2, nedsat hæmoglobin2, nedsat trombocyttal2 Ikke almindelig: anæmi1, 4