natgillin/translations-raw huggingface dataset:
d Der var 10 nye virologiske svigt mellem den primære analyse ved uge 48 og uge 96 (3 patienter med baseline virusbelastning ≤ 100.000 kopier/ml og 7 patienter med baseline virusbelastning > 100.000 kopier/ml).
d There were 10 new virologic failures between the week 48 primary analysis and week 96 (3 patients with baseline viral load ≤ 100,000 copies/mL and 7 patients with baseline viral load > 100,000 copies/mL).
Derfor bør Eviplera kun anvendes hos patienter med let nedsat nyrefunktion, hvis de mulige fordele ved behandlingen opvejer mulige risici (se pkt.
Therefore, in patients with mild renal impairment Eviplera should only be used if the potential benefits of treatment outweigh the potential risks (see sections 4.4 and 5.2).
IMMUNOSUPPRESIVA Tacrolimus/Tenofovirdisoproxil/Emtricitabin Tacrolimus:
IMMUNOSUPPRESSANTS Tacrolimus/Tenofovir disoproxil/ Emtricitabine
Emtricitabins farmakokinetik er ikke blevet undersøgt hos patienter med forskellige grader af leverinsufficiens.
The pharmacokinetics of emtricitabine has not been studied in patients with varying degrees of hepatic insufficiency.
HMG CO-A-REDUKTASEHÆMMERE Atorvastatin/Emtricitabin
HMG CO-A REDUCTASE INHIBITORS Atorvastatin/Emtricitabine
Eviplera bør administreres med forsigtighed til ældre patienter (se pkt.
Eviplera should be administered with caution to elderly patients (see sections 4.4 and 5.2).
Didanosin Samtidig administration af Eviplera og didanosin anbefales ikke (se pkt.
Didanosine The co-administration of Eviplera and didanosine is not recommended (see section 4.4 and Table 1).
Virologisk svigtc
Virologic failurec
Sildenafil (50 mg enkeltdosis)/Rilpivirin1
Sildenafil (50 mg single dose)/ Rilpivirine1
Samtidig administration af Eviplera og didanosin frarådes, da eksponering for didanosin er signifikant forhøjet efter samtidig administration af tenofovirdisoproxil, hvilket kan øge risikoen for didanosinrelaterede bivirkninger (se pkt.
Co-administration of Eviplera and didanosine is not recommended since exposure to didanosine is significantly increased following co-administration with tenofovir disoproxil, which may increase the risk of didanosine-related adverse reactions (see section 4.5).
Eviplera indeholder lactose og Sunset yellow FCF aluminium lak (E110)
Eviplera contains lactose and sunset yellow aluminium lake (E110)
Hvis en patient kaster op inden for 4 timer efter at have taget Eviplera, skal der tages en ny Evipleratablet sammen med mad.
If a patient vomits within 4 hours of taking Eviplera another Eviplera tablet should be taken with food.
Eviplera skal tages sammen med mad (se pkt.
Eviplera must be taken with food (see section 5.2).
forhøjede aminotransferaser (ASAT og/eller ALAT)1, 2, 3
Very common: increased transaminases (AST and/or ALT)1, 2, 3 Common:
H2-antagonister bør ikke tages i et program med indtagelse to gange dagligt.
H2-antagonists should not be taken in a twice a day regimen.
Interaktion er ikke undersøgt med Eviplera.
Interaction not studied with Eviplera.
Procentdel af patienter med samtidig infektion med HBV/HCV
HIV/HBV or HCV co-infected patients
Eviplera 200 mg/25 mg/245 mg filmovertrukne tabletter emtricitabin/rilpivirin/tenofovirdisoproxil
Eviplera 200 mg/25 mg/245 mg film-coated tablets emtricitabine/rilpivirine/tenofovir disoproxil
Når De snart ikke har mere af Eviplera, skal De bede om mere fra lægen eller på apoteket.
When your supply of Eviplera starts to run low, get more from your doctor or pharmacist.
Rilpivirinhydrochlorid er ikke undersøgt hos patienter med svært nedsat leverfunktion (CPT score C).
Rilpivirine hydrochloride has not been studied in patients with severe hepatic impairment (CPT Score C).
Hos patienter med virusbelastning ved baseline > 100.000 kop ier/ml (n = 44)
In patients with BL VL1 > 100,000 copies/mL (n = 44)
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.
• Fortæl Deres læge, hvis De lider af allergi over for Sunset yellow FCF aluminium lak
• Tell your doctor if you have an allergy to sunset yellow aluminium lake (E110).
Det er blevet observeret, at samtidig administration af Eviplera og lægemidler, der hæmmer CYP3A enzymaktiviten kan forhøje plasmakoncentrationer af rilpivirin.
Co-administration of Eviplera with medicinal products that inhibit CYP3A enzyme activity has been observed to increase rilpivirine plasma concentrations.
Det er blevet observeret, at samtidig administration af Eviplera og lægemidler, der inducerer CYP3A, nedsætter plasmakoncentrationer af rilpivirin, hvilket kunne medføre tab af den terapeutiske virkning af Eviplera (se pkt.
Co-administration of Eviplera and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3).
Antimykobakterielle midler Rifabutin/Emtricitabin
Antimycobacterials Rifabutin/Emtricitabine
 Hvis De tror, De har laktatacidose, skal De straks fortælle det til lægen.
 If you think you may have lactic acidosis, tell your doctor immediately.
Antiretrovirale lægemidler
Antiretrovirals
Antivirale midler mod herpesvirus Famciclovir/Emtricitabin
Herpesvirus antiviral agents Famciclovir/Emtricitabine
Da tenofovirdisoproxil kan forårsage nyretoksicitet, anbefales tæt monitorering af nyrefunktionen hos alle patienter med nedsat nyrefunktion, som behandles med Eviplera (se pkt.
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).
Maraviroc/Rilpivirin
Maraviroc/Rilpivirine
hepatitis3, steatosis hepatis3 Hud og subkutane væv Meget almindelig:
hepatitis3, hepatic steatosis3
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.
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.
• Tenofovirdisoproxil, en nukleotid revers transkriptasehæmmer (NtRTI).
• Tenofovir disoproxil, a nucleotide reverse transcriptase inhibitor (NtRTI).
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
Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg + 100 mg once daily)5/ Rilpivirine/Emtricitabine (25 mg/200 mg once daily)6
Nyrefunktionen bør monitoreres hos patienter, som får Eviplera (se pkt.
Monitoring of renal function is recommended for patients receiving Eviplera (see section 4.4).
Indlægsseddel: Information til brugeren Eviplera 200 mg/25 mg/245 mg filmovertrukne tabletter emtricitabin/rilpivirin/tenofovirdisoproxil
Package leaflet: Information for the user Eviplera 200 mg/25 mg/245 mg film-coated tablets emtricitabine/rilpivirine/tenofovir disoproxil
Antimykotika Ketoconazol/Emtricitabin
Antifungals Ketoconazole/Emtricitabine
ETIKETTERING PÅ TABLETBEHOLDER OG KARTON
BOTTLE AND CARTON LABELLING
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).
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).
Darunavir (800 mg én gang dagligt)/Ritonavir (100 mg én gang dagligt)/Rilpivirin1
Darunavir (800 mg once daily)/ Ritonavir (100 mg once daily)/ Rilpivirine1
Prækliniske data for rilpivirinhydrochlorid viser ingen speciel risiko for mennesker vurderet ud fra studier af sikkerhedsfarmakologi, lægemiddeldisposition, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
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.
forhøjet pancreasamylase2, opkastning1, 2, 3, diarré1, 3, kvalme1, 2, 3
Very common: increased pancreatic amylase2, vomiting1, 2, 3, diarrhoea1, 3, nausea1, 2, 3
Ikke almindelig: angioødem1, 3, 6, alvorlige hudreaktioner med systemiske symptomer7 Knogler, led, muskler og bindevæv
angioedema1, 3, 6, severe skin reactions with systemic symptoms7 Musculoskeletal and connective tissue disorders Very common: elevated creatine kinase1
Interaktion er ikke undersøgt med nogen af komponenterne fra Eviplera.
Interaction not studied with any of the components of Eviplera.
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).
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).
Yderligere behandlingstiltag bør, hvis muligt, bygge på de kliniske tegn eller følge anbefalingerne fra Giftlinjen.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Behandlingsnaive hiv 1-inficerede patienter
Treatment-naïve HIV-1 infected patients
Samtidig administration af Eviplera og didanosin frarådes (se pkt.
Co-administration of Eviplera and didanosine is not recommended (see section 4.4).
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.
Discontinuation of Eviplera therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
• Bevægelsesbesvær
• Difficulty with movement
I behandlingsnaive hiv 1-inficerede patienter
In treatment-naïve HIV-1 infected patients
Raltegravir/Rilpivirin
Raltegravir/Rilpivirine
Induktionsvirkningen faldt, og rilpivirin-koncentrationerne begyndte at normaliseres på grund af reduktion i efavirenzplasmaniveauet.
Due to the decline in efavirenz plasma levels, the inductive effect decreased and rilpivirine concentrations started to normalise.
Nervesystemet Meget almindelig:
Immune system disorders Common:
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.
Ikke almindelig: rabdomyolyse3, 5, muskelsvaghed3, 5 Sjælden:
rhabdomyolysis3, 5, muscular weakness3, 5
Ikke almindelig: pancreatitis3
pancreatitis3
Lægemidler, der inducerer eller hæmmer CYP3A, kan derfor påvirke clearance af rilpivirin (se pkt.
Rilpivirine is primarily metabolised by CYP3A Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
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.
Two of the active substances in Eviplera (tenofovir disoproxil and emtricitabine) show some activity against hepatitis B virus.
Rilpivirin er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (CPT score C) (se pkt.
Rilpivirine has not been studied in patients with severe hepatic impairment (CPT Score C) (see section 4.2).
Hyppighed Bivirkning Blod- og lymfesystem Almindelig:
Adverse reaction Blood and lymphatic system disorders
Eviplera er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (CPT score C).
Eviplera has not been studied in patients with severe hepatic impairment (CPT Score C).
(kan opstå hos mere end 1 ud af 10 personer)
(may affect more than 1 in 10 people)
Rilpivirins farmakokinetik er ikke undersøgt hos patienter med nedsat nyrefunktion.
The pharmacokinetics of rilpivirine has not been studied in patients with renal insufficiency.
Prækliniske data for tenofovirdisoproxil viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet, karcinogenicitet samt reproduktions og udviklingstoksicitet.
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.
Af disse virologiske svigt forekom 5/15 (rilpivirin) og 5/14 (efavirenz) hos patienter med en virusbelastning på ≤ 100.000 kopier/ml ved baseline.
(rilpivirine) and 5/14 (efavirenz) were in patients with a baseline viral load of ≤ 100,000 copies/mL.
Emtricitabins farmakokinetik er ikke undersøgt hos patienter med nedsat leverfunktion.
The pharmacokinetics of emtricitabine has not been studied in patients with hepatic impairment.
Metformin (850 mg enkeltdosis)/Rilpivirin Metformin:
Metformin (850 mg single dose)/ Rilpivirine
Lopinavir (400 mg to gange dagligt)/Ritonavir (100 mg to gange dagligt)/Rilpivirin1 (blød kapsel)
Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Rilpivirine1 (soft capsule)
Kombinationen af Eviplera og disse makrolidantibiotika kan forårsage en forhøjelse af plasmakoncentrationerne af rilpivirin (hæmmere af CYP3A-enzymer).
The combination of Eviplera with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
• Fedtlever
• Fatty liver
(interaktionsmekanismen er ikke kendt)
(mechanism of interaction unknown) Tenofovir:
Ethinylestradiol/Norethindron/Emtricitabin Interaktion er ikke undersøgt.
Lopinavir/Ritonavir/Emtricitabine Interaction not studied.
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.
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).
• 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
• Rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
(kan opstå hos op til 1 ud af 1.000 personer)
(may affect up to 1 in 1,000 people)
Digoxin/Rilpivirin
Digoxin/Rilpivirine
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.
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.
Andre antivirale midler Ledipasvir/sofosbuvir (90 mg/400 mg én gang dagligt)/Emtricitabin/rilpivirin/ tenofovirdisoproxil (200 mg/25 mg/245 mg én gang dagligt)
Other antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg once daily)
• Emtricitabin, en nukleosid revers transkriptasehæmmer (NRTI).
• Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI).
Resistenstest for genotype og/eller historiske resistensdata skal være vejledende for anvendelsen af Eviplera (se pkt.
Genotypic resistance testing and/or historical resistance data should guide the use of Eviplera (see sections 4.4 and 5.1).
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).
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).
Norgestimat/Ethinylestradiol/ Tenofovirdisoproxil
Norgestimate/Ethinylestradiol/ Tenofovir disoproxil
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.
In general, emtricitabine pharmacokinetics in HBV infected patients was similar to those in healthy subjects and in HIV infected patients.
4.4, 4.6, 5.1 og 5.2).
Alternatively, switching to another antiretroviral regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).
Hver filmovertrukken tablet indeholder 200 mg emtricitabin, 25 mg rilpivirin (som hydrochlorid) og 245 mg tenofovirdisoproxil (som fumarat).
Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate).
Eviplera indgives sammen med rifabutin, anbefales det at tage yderligere én rilpivirin-tablet på 25 mg dagligt samtidig med
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.
Eviplera bør ikke indgives samtidig med adefovirdipivoxil (se pkt.
Eviplera should not be administered concomitantly with adefovir dipivoxil (see section 4.5).
NATURLÆGEMIDLER Perikon (Hypericum perforatum)
HERBAL PRODUCTS St. John's wort (Hypericum perforatum)
Det er usandsynligt, at en dosisjustering af Eviplera vil være nødvendig hos patienter med let eller moderat nedsat leverfunktion (se pkt.
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).
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).
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).
Ethinylestradiol/Norethindron/ Tenofovirdisoproxil
Ethinylestradiol/Norethindrone/ Tenofovir disoproxil
AUC: ↓ 10 % C12t: ↓ 13 % Cmax: ↓ 23 %
AUC: ↓ 10% C12h: ↓ 13% Cmax: ↓ 23%
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
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
Hver Eviplera filmovertrukket tablet indeholder 200 mg emtricitabin, 25 mg rilpivirin (som hydrochlorid) og 245 mg tenofovirdisoproxil (som fumarat).
Each Eviplera film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate).
Simeprevir (150 mg en gang dagligt)/rilpivirin (25 mg en gang dagligt)
Simeprevir (150 mg once daily)/ Rilpivirine (25 mg once daily)
5.1) indikerer, at den korte periode med lavere rilpivirin-eksponering ikke påvirker Evipleras antivirale virkning.
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.
ANTIARYTMIKA Digoxin/Emtricitabin
ANTIARRHYTHMICS Digoxin/Emtricitabine
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.
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.
Paracetamol (500 mg enkeltdosis)/Rilpivirin1 Paracetamol:
Paracetamol (500 mg single dose)/ Rilpivirine1
Sofosbuvir/ tenofovirdisoproxil
Sofosbuvir/Tenofovir disoproxil
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
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
Rifabutin kan nedsætte mængden af rilpivirin (et aktivt stof i Eviplera) i Deres blod.
This medicine can decrease the amount of rilpivirine (a component of Eviplera) in your blood.
• Problemer med bugspytkirtlen
• Pancreas problems
Rifampicin (600 mg én gang dagligt)/ Rilpivirin1
Rifampicin (600 mg once daily)/ Rilpivirine1
• Døsighed
• Drowsiness
Eviplera må ikke anvendes sammen med præparater, der indeholder perikon, da samtidig administration kan forårsage signifikant reduktion i plasmakoncentrationen af rilpivirin.
Eviplera must not be used in combination with products containing St. John's wort as coadministration may cause significant decreases in rilpivirine plasma concentrations.
Efavirenz + emtricitabin/ tenofovirdisoproxil n = 550
Rilpivirine + Emtricitabine/Tenofovir disoproxil n = 550
Atorvastatin (40 mg én gang dagligt)/ Rilpivirin1
Atorvastatin (40 mg once daily)/ Rilpivirine1
Da Eviplera kan foråsage nyreskader, anbefales monitorering af nyrefunktionen (se pkt.
As Eviplera may cause renal damage, monitoring of renal function is recommended (see sections 4.4 and 4.8, Summary of the safety profile).