FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions associated with the use of efavirenz/emtricitabine/tenofovir disoproxil: Treatmentemergent adverse reactions considered possibly or probably related to efavirenz/emtricitabine/tenofovir disoproxil reported in study AI266073 (over 48 weeks; n = 203), which have not been associated with one of the individual components of efavirenz/emtricitabine/tenofovir disoproxil, include:
Danish: Bivirkninger som er forbundet med anvendelse af efavirenz/emtricitabin/tenofovirdisoproxil: Bivirkninger [rapporteret i studie AI266073 (over 48 uger, n=203)], som opstod under behandlingen, og som blev anset for muligvis eller sandsynligvis at være relateret til efavirenz/emtricitabin/tenofovirdisoproxil, og som ikke er blevet relateret til et af de aktive stoffer i efavirenz/emtricitabin/tenofovirdisoproxil, omfatter:
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may cause dizziness, impaired concentration and drowsiness.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan kan give svimmelhed, nedsat koncentrationsevne og døsighed.
English: The safety and efficacy of efavirenz/emtricitabine/tenofovir disoproxil in children under the age of 18 years have not been established.
Danish: Sikkerhed og virkning af efavirenz/emtricitabin/tenofovirdisoproxil hos børn og unge under 18 år er ikke klarlagt.
English: Discontinuation of efavirenz/emtricitabine/tenofovir disoproxil therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Danish: Seponering af efavirenz/emtricitabin/tenofovirdisoproxil hos patienter, der har både hiv og HBV, kan være forbundet med svær, akut forværring af hepatitis.
English: The adverse reactions from clinical study and post-marketing experience with efavirenz/emtricitabine/tenofovir disoproxil and the individual components of efavirenz/emtricitabine/tenofovir disoproxil in antiretroviral combination therapy are listed in Table 2 below by body system organ class, frequency and the component(s) of efavirenz/emtricitabine/tenofovir disoproxil to which the adverse reactions are attributable.
Danish: I tabel 2 nedenfor ses bivirkningerne fra kliniske studier samt erfaring efter markedsføringen med efavirenz/emtricitabin/tenofovirdisoproxil og de aktive stoffer i efavirenz/emtricitabin/tenofovirdisoproxil inddelt i systemorganklasse, frekvens og efavirenz/emtricitabin/tenofovirdisoproxil-komponent(er), som bivirkningerne kan tilskrives.
English: The bone toxicity in young adult rats and dogs occurred at exposures ≥ 5-fold the exposure in paediatric or adult patients; bone toxicity occurred in juvenile infected monkeys at very high exposures following subcutaneous dosing (≥ 40-fold the exposure in patients).
Danish: Knogletoksicitet forekom hos unge inficerede aber ved meget høje eksponeringer efter subkutan dosering (≥ 40 gange eksponeringen hos patienter).
English: AUC: ↓ 4% (↓ 0 to ↓ 31) Cmax: ↓ 47% (↓ 9 to ↓ 51) Total active HMG Co-A reductase inhibitors:
Danish: AUC: ↓ 4% (↓ 0 til ↓ 31) Cmax: ↓ 47% (↓ 9 til ↓ 51) Totalt antal aktive HMG Co-A reduktasehæmmere:
English: The pharmacokinetics, safety and efficacy of efavirenz/emtricitabine/tenofovir disoproxil have not been established in patients with significant underlying liver disorders (see section 5.2).
Danish: Farmakokinetik, sikkerhed og virkning af efavirenz/emtricitabin/tenofovirdisoproxil er ikke klarlagt hos patienter med signifikante, underliggende leversygdomme (se pkt.
English: Raltegravir/Tenofovir disoproxil (400 mg b.i.d./-)
Danish: Raltegravir/tenofovirdisoproxil (400 mg b.i.d./−)
English: *lower than recommended doses; similar findings are expected with recommended doses.
Danish: Tilsvarende fund forventes med anbefalede doser.
English: Patients with renal impairment: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any patient with mild renal impairment treated with efavirenz/emtricitabine/tenofovir disoproxil (see sections 4.2, 4.4 and 5.2).
Danish: Patienter med nedsat nyrefunktion: Da tenofovirdisoproxil kan forårsage nyretoksicitet, anbefales tæt monitorering af nyrefunktionen hos alle patienter med let nedsat nyrefunktion, som behandles med efavirenz/emtricitabin/tenofovirdisoproxil (se pkt.
English: AUC: ↓ 75% (↓ 59 to ↓ 84) Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75) N-monodesmethyl diltiazem: AUC: ↓ 37% (↓ 17 to ↓ 52) Cmax: ↓ 28% (↓ 7 to ↓ 44) Cmin: ↓ 37% (↓ 17 to ↓ 52) Efavirenz:
Danish: AUC: ↓ 75% (↓ 59 til ↓ 84) Cmax: ↓ 64% (↓ 57 til ↓ 69) Cmin: ↓ 62% (↓ 44 til ↓ 75) N-monodesmethyldiltiazem: AUC: ↓ 37% (↓ 17 til ↓ 52) Cmax: ↓ 28% (↓ 7 til ↓ 44) Cmin: ↓ 37% (↓ 17 til ↓ 52) Efavirenz:
English: Prior efavirenz/emtricitabine/tenofovir disoproxil components (N=299)
Danish: Tidligere efavirenz/emtricitabin/tenofovirdisoproxilkomponenter (N=299)
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 skal overvejes hos alle børn med svære kliniske symptomer af ukendt ætiologi, især neurologiske symptomer, der har været eksponeret for nukleosid-/nukleotidanaloger in utero.
English: - You must remain under the care of your doctor while taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Danish: - De skal fortsat være i behandling hos Deres læge, mens De tager Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: Plasma trough concentrations of boceprevir were decreased when administered with efavirenz, a component of efavirenz/emtricitabine/tenofovir disoproxil.
Danish: Dalplasmakoncentrationen af boceprevir blev reduceret ved administration sammen med efavirenz, en komponent i efavirenz/emtricitabin/tenofovirdi soproxil.
English: Elderly: efavirenz/emtricitabine/tenofovir disoproxil has not been studied in patients over the age of 65.
Danish: Ældre: efavirenz/emtricitabin/tenofovirdisoproxil er ikke blevet undersøgt hos patienter over 65 år.
English: Convulsions have been observed in patients receiving efavirenz, generally in the presence of a known medical history of seizures.
Danish: Der er set krampeanfald hos patienter i behandling med efavirenz, sædvanligvis i forbindelse med kramper i anamnesen.
English: Hydroxyitraconazole: AUC: ↓ 37% (↓ 14 to ↓ 55) Cmax: ↓ 35% (↓ 12 to ↓ 52) Cmin: ↓ 43% (↓ 18 to ↓ 60) Efavirenz:
Danish: Hydroxyitraconazol: AUC: ↓ 37% (↓ 14 til ↓ 55) Cmax: ↓ 35% (↓ 12 til ↓ 52) Cmin: ↓ 43% (↓ 18 til ↓ 60) Efavirenz:
English: AUC: ↓ 26% (↓ 15 to ↓ 36) Cmax: ↓ 20% (↓ 11 to ↓ 28) Cmin: ↓ 32% (↓ 15 to ↓ 46) (CYP3A4 and CYP2B6 induction)
Danish: AUC: ↓ 26% (↓ 15 til ↓ 36) Cmax: ↓ 20% (↓ 11 til ↓ 28) Cmin: ↓ 32% (↓ 15 til ↓ 46) (CYP3A4- og CYP2B6induktion)
English: Didanosine/Emtricitabine
Danish: Didanosine/emtricitabin
English: If the patient vomits within 1 hour of taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, another tablet should be taken.
Danish: Hvis patienten kaster op inden for 1 time efter at have taget Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, skal der tages en ny tablet.
English: Monitoring of renal function is recommended for patients receiving efavirenz/emtricitabine/tenofovir disoproxil (see section 4.4).
Danish: Nyrefunktionen skal monitoreres hos patienter, som får efavirenz/emtricitabin/tenofovirdisoproxil (se pkt.
English: Tenofovir disoproxil and emtricitabine, two of the active substances in Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, show some activity against hepatitis B virus although emtricitabine is not approved for the treatment of hepatitis B infection.
Danish: Hvis De har en hepatitis B-infektion, vil Deres læge nøje overveje, hvilken behandling, der er den bedste for Dem. Tenofovirdisoproxil og emtricitabin, to af de aktive stoffer i Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, har en vis virkning mod hepatitis Bvirus, selvom emtricitabin ikke er godkendt til behandling af hepatitis B-infektion.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as maleate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 600 mg efavirenz, 200 mg emtricitabin og 245 mg tenofovirdisoproxil (som maleat).
English: AUC: ↓ 58% (↓ 39 to ↓ 68) Cmax: ↓ 51% (↓ 32 to ↓ 58) Total active HMG Co-A reductase inhibitors:
Danish: AUC: ↓ 58% (↓ 39 til ↓ 68) Cmax: ↓ 51% (↓ 32 til ↓ 58) Totalt antal aktive HMG Co-A reduktasehæmmere:
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets efavirenz/emtricitabine/tenofovir disoproxil
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg filmovertrukne tabletter efavirenz/emtricitabin/tenofovirdisoproxil
English: Efavirenz/emtricitabine/tenofovir disoproxil is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min).
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan må ikke gives til patienter med moderat eller svært nedsat nyrefunktion (kreatininclearance < 50 ml/min).
English: No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents
Danish: Der er ingen tilgængelige data til at understøtte kombinationen af efavirenz/emtricitabin/tenofovirdisoproxil og andre antiretrovirale lægemidler.
English: Due to similarities with emtricitabine, efavirenz/emtricitabine/tenofovir disoproxil should not be administered concomitantly with other cytidine analogues, such as lamivudine.
Danish: På grund af ligheder med emtricibatin må efavirenz/emtricitabin/tenofovirdisoproxil ikke gives samtidigt med andre cytidinanaloger som lamivudin.
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24) Sofosbuvir:
Danish: AUC: ↓ 34% (↓ 41 til ↓ 25) Cmax: ↓ 34% (↓ 41 til ↑ 25) Cmin: ↓ 34% (↓ 43 til ↑ 24) Sofosbuvir:
English: As a fixed combination, efavirenz/emtricitabine/tenofovir disoproxil should not be administered concomitantly with other medicinal products containing the same active components, emtricitabine or tenofovir disoproxil.
Danish: Som en fast kombination må efavirenz/emtricitabin/tenofovirdisoproxil ikke gives samtidigt med andre lægemidler, der indeholder de samme aktive komponenter, emtricitabin eller tenofovirdisoproxil.
English: NNRTIs/Efavirenz
Danish: NNRTI'er/efavirenz
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 hivnegative spædbørn, som har været eksponeret for nukleosidanaloger in utero og/eller postnatalt.
English: -0.5% (-3.2% to 2.2%)
Danish: 98,9% -0,5% (-3,2% til 2,2%)
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan can reduce the amount of statins in your blood.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan kan nedsætte mængden af statiner i blodet.
English: Common hypertriglyceridaemia3 hyperglycaemia, hypertriglyceridaemia
Danish: Hyperglykæmi, hypertriglyceridæmi
English: Since Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a fixed-dose combination product, the dose of efavirenz cannot be altered (see section 4.5).
Danish: Da Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan er et fastdosis kombinationsprodukt, kan efavirenzdosis ikke ændres (se pkt.
English: What Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan looks like and contents of the pack Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan film-coated tablets are pink capsule-shaped tablets, engraved with ‘M' on one side and ‘TME' on the other side.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan filmovertrukne tabletter er lyserøde, kapselformede tabletter, på den ene side præget med ‘M' og på den anden side ‘TME'.
English: AUC: ↑ 49% C12h: ↑ 3%
Danish: C12t: ↑ 3%
English: The clinical implications of such an association are unknown; however, the potential for an increased frequency and severity of efavirenz-associated adverse events cannot be excluded.
Danish: Muligheden for øget hyppighed af efavirenz-associerede bivirkninger kan dog ikke udelukkes, ligesom sværhedsgraden af disse ikke er kendt.
English: Table 2: Adverse reactions associated with efavirenz/emtricitabine/tenofovir disoproxil listed by the component(s) of efavirenz/emtricitabine/tenofovir disoproxil to which the adverse reactions are attributable
Danish: Tabel 2: Bivirkninger som er forbundet med efavirenz/emtricitabin/tenofovirdisoproxil, opstillet efter den efavirenz/emtricitabin/tenofovirdisoproxil-komponent, som bivirkningen kan tilskrives.
English: Recommendation concerning coadministration with efavirenz/emtricitabine/tenofovir disoproxil (efavirenz 600 mg, emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Danish: Anbefaling vedrørende samtidig indgivelse med efavirenz/emtricitabin/tenofovir disoproxil (efavirenz 600 mg, emtricitabin 200 mg, tenofovirdisoproxil 245 mg)
English: AUC: ↓ 35% (↓ 13 to ↓ 40) Cmax: ↓ 13% (↓ 0 to ↓ 23) 4-hydroxy atorvastatin:
Danish: AUC: ↓ 35% (↓ 13 til ↓ 40) Cmax: ↓ 13% (↓ 0 til ↓ 23) 4-hydroxyatorvastatin:
English: Where discontinuation of therapy with one of the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is indicated or where dose modification is necessary, separate preparations of efavirenz, emtricitabine and tenofovir disoproxil are available.
Danish: Hvis seponering af behandling med en af komponenterne i Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan er indiceret, eller hvis dosismodificering er påkrævet, er separate efavirenz-, emtricitabin- og tenofovirdisoproxil-præparater tilgængelige.
English: Co-administration of efavirenz/emtricitabine/tenofovir disoproxil and didanosine is not recommended since exposure to didanosine is significantly increased following co-administration with tenofovir disoproxil that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Danish: Samtidig administration af efavirenz/emtricitabin/tenofovirdisoproxil og didanosin frarådes, da didanosin-eksponeringen øges signifikant efter samtidig administration af tenofovirdisoproxil, hvilket kan øge risikoen for didanosin-relaterede bivirkninger (se pkt.
English: Dose adjustments of calcium channel blockers when co-administered with efavirenz/emtricitabine/tenofovir disoproxil should be guided by clinical response (refer to the Summary of Product Characteristics for the calcium channel blocker).
Danish: Dosisjusteringer af calciumblokkere, når disse administreres samtidigt med efavirenz/emtricitabin/tenofovirdi soproxil, skal styres af klinisk respons (se produktresuméet for calciumblokkeren).
English: Plasma concentrations and effects of warfarin or acenocoumarol are
Danish: Warfarins eller acenocoumarols plasmakoncentrationer og virkninger kan muligvis forhøjes eller reduceres af efavirenz.
English: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin 35/36 Baldoyle Industrial Estate, Baldoyle, Dublin 13 Ireland
Danish: 35/36 Baldoyle Industrial Estate, Baldoyle, Dublin 13
English: AUC: ↔ Cmax: ↔ Emtricitabine: AUC: ↔ Cmax: ↔
Danish: AUC: ↔ Cmax: ↔ Emtricitabin: AUC: ↔ Cmax: ↔
English: Efavirenz/emtricitabine/tenofovir disoproxil Efavirenz
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil Efavirenz
English: Efavirenz/emtricitabine/tenofovir disoproxil was administered on an empty stomach (see section 4.2).
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil blev administreret på tom mave (se pkt.
English: Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/Efavirenz (50 mg q.d./600 mg q.d.)
Danish: Selektive serotonin-reuptake-hæmmere (SSRI'er) Sertralin/efavirenz (50 mg q.d./ 600 mg q.d.)
English: Co-administration of ritonavir at doses of 600 mg and efavirenz/emtricitabine/tenofovir disoproxil is not recommended.
Danish: Samtidig administration af ritonavir ved doser på 600 mg og efavirenz/emtricitabin/tenofovirdi soproxil frarådes.
English: Where discontinuation of therapy with one of the components of efavirenz/emtricitabine/tenofovir disoproxil is indicated or where dose modification is necessary, separate preparations of efavirenz, emtricitabine and tenofovir disoproxil are available.
Danish: Hvis seponering af behandling med en af komponenterne i efavirenz/emtricitabin/tenofovirdisoproxil er indiceret, eller hvis dosismodificering er påkrævet, er separate efavirenz-, emtricitabin- og tenofovirdisoproxilpræparater tilgængelige.
English: Efavirenz/emtricitabine/tenofovir disoproxil has not been studied in patients over the age of 65.
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil er ikke blevet undersøgt hos patienter over 65 år.
English: Efavirenz/emtricitabine/tenofovir disoproxil is not recommended in this population (see section 4.2).
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil må ikke anvendes til denne population (se pkt.
English: Voriconazole/Emtricitabine
Danish: Voriconazol/emtricitabin
English: Lopinavir/ritonavir soft capsules or oral solution/Efavirenz
Danish: Bløde kapsler med lopinavir/ritonavir eller oral opløsning/efavirenz
English: Protease inhibitors Atazanavir/ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Danish: Proteasehæmmere Atazanavir/ritonavir/tenofovirdisopro xil (300 mg q.d./ 100 mg q.d./ 245 mg q.d.)
English: AUC0-last
Danish: AUC0-sidst
English: NAME OF THE MEDICINAL PRODUCT Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg filmovertrukne tabletter
English: AUC: ↓ 39% (↓ 21 to ↓ 53) Cmax: ↓ 37% (↓ 20 to ↓ 51) Cmin: ↓ 44% (↓ 27 to ↓ 58) (decrease in itraconazole concentrations: CYP3A4 induction)
Danish: AUC: ↓ 39% (↓ 21 til ↓ 53) Cmax: ↓ 37% (↓ 20 til ↓ 51) Cmin: ↓ 44% (↓ 27 til ↓ 58) (fald i itraconazolkoncentrationen: CYP3A4induktion)
English: AUC: ↓ 43% (↓ 34 to ↓ 50) Cmax: ↓ 12% (↓ 1 to ↓ 26) 2-hydroxy atorvastatin:
Danish: AUC: ↓ 43% (↓ 34 til ↓ 50) Cmax: ↓ 12% (↓ 1 til ↓ 26) 2-hydroxyatorvastatin:
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Danish: Hos patienter i behandling med tenofovirdisoproxil med risikofaktorer for renal dysfunktion er der blevet rapporteret tilfælde af akut nyresvigt efter påbegyndelse af højdosisbehandling med nonsteroide antiinflammatoriske midler (NSAID'er) og behandling med flere NSAID'er.
English: If the patient vomits more than 1 hour after taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan he/she does not need to take another dose.
Danish: Hvis patienten kaster op mere end 1 time efter at have taget Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, skal patienten ikke tage en ny dosis.
English: Sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir: Co-administration of efavirenz/emtricitabine/tenofovir disoproxil and sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir is not recommended (see section 4.4 and Table 1).
Danish: Sofosbuvir/velpatasvir og sofosbuvir/velpatasvir/voxilaprevir: Samtidig administration af efavirenz/emtricitabin/tenofovirdisoproxil og sofosbuvir/velpatasvir eller sofosbuvir/velpatasvir/voxilaprevir frarådes (se pkt.
English: Lopinavir/ritonavir/Tenofovir disoproxil (400 mg b.i.d./100 mg b.i.d./245 mg q.d.)
Danish: Lopinavir/ritonavir/tenofovirdisoprox il (400 mg b.i.d./ 100 mg b.i.d./ 245 mg q.d.)
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may affect your kidneys.
Danish: - Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan kan påvirke Deres nyrer.
English: Patients with moderate or severe renal impairment require a dose adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
Danish: Hos patienter med moderat eller svært nedsat nyrefunktion er det nødvendigt med justering af emtricitabin- og tenofovirdisoproxildosis, som ikke kan opnås med kombinationstabletten (se pkt.
English: Women of childbearing potential should undergo pregnancy testing before initiation of efavirenz/emtricitabine/tenofovir disoproxil.
Danish: Kvinder i den fertile alder skal altid få foretaget graviditetstest før initiering af behandling med efavirenz/emtricitabin/tenofovirdisoproxil.
English: In combination studies evaluating the in vitro antiviral activity of efavirenz and emtricitabine together, efavirenz and tenofovir together, and emtricitabine and tenofovir together, additive to synergistic antiviral effects were observed.
Danish: Additiv til synergistiske virkninger blev observeret i kombinationsstudier til vurdering af den samlede antivirale aktivitet for efavirenz og emtricitabin in vitro samt emtricitabins og tenofovirs samlede antivirale aktivitet.
English: Atovaquone and proguanil hydrochloride/Tenofovir disoproxil
Danish: Atovaquon og proguanilhydrochlorid/tenofovirdisop roxil
English: When using efavirenz/emtricitabine/enofovir disoproxil with low-dose ritonavir, the possibility of an increase in the incidence of efavirenz-associated
Danish: Ved anvendelse af efavirenz/emtricitabin/enofovirdis oproxil sammen med en lav dosis ritonavir skal risikoen for en øgning i forekomst af efavirenzassocierede bivirkninger overvejes pga mulig farmakodynamisk interaktion.
English: AUC: ↓ 71% (↓ 67 to ↓ 74) Cmax: ↓ 51% (↓ 46 to ↓ 56) Cmin: ↓ 91% (↓ 88 to ↓ 92) Efavirenz:
Danish: AUC: ↓ 71% (↓ 67 til ↓ 74) Cmax: ↓ 51% (↓ 46 til ↓ 56) Cmin: ↓ 91% (↓ 88 til ↓ 92) Efavirenz:
English: Methadone/Tenofovir disoproxil (40-110 mg q.d./245 mg q.d.)
Danish: Methadon/tenofovirdisoproxil (40-110 mg q.d./ 245 mg q.d.)
English: Slovenská republika Mylan s.r.o.
Danish: Mylan Italia S.r.l.
English: Dose adjustment of buprenorphine may not be necessary when coadministered with efavirenz/emtricitabine/tenofovir disoproxil.
Danish: Dosisjustering af buprenorphin er muligvis ikke nødvendig, når det administreres samtidigt med efavirenz/emtricitabin/tenofovirdi soproxil.
English: Therefore efavirenz/emtricitabine/tenofovir disoproxil should not be used during breast-feeding.
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil bør derfor ikke anvendes under amning.
English: Therefore coadministration of atazanavir/ritonavir and efavirenz/emtricitabine/tenofovir disoproxil is not recommended (see Table 1).
Danish: Samtidig administration af atazanavir/ritonavir og efavirenz/emtricitabin/tenofovirdisoproxil frarådes derfor (se tabel 1).
English: Norgestimate/Ethinyloestradiol/ Emtricitabine
Danish: Norgestimat/ethinyloestradiol/emtrici tabin
English: Darunavir/ritonavir/Tenofovir disoproxil (300 mg b.i.d.
Danish: Darunavir/ritonavir/tenofovirdisoprox il (300 mg b.i.d.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may make hormonal contraceptives less likely to work.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan kan forårsage, at hormonale præventionsmidler ikke virker så godt.
English: AUC: ↓ 53% (↓ 61 to ↓ 43) Cmax: ↓ 47% (↓ 57 to ↓ 36) Cmin: ↓ 57% (↓ 64 to ↓ 48) Efavirenz:
Danish: AUC: ↓ 53% (↓ 61 til ↓ 43) Cmax: ↓ 47% (↓ 57 til ↓ 36) Cmin: ↓ 57% (↓ 64 til ↓ 48) Efavirenz:
English: Mild-to-moderate rash has been reported with the individual components of efavirenz/emtricitabine/tenofovir disoproxil.
Danish: Der er indberettet let til moderat udslæt som følge af de individuelle komponenter med efavirenz/emtricitabin/tenofovirdisoproxil.
English: Efavirenz/emtricitabine/tenofovir disoproxil has not been evaluated in the presence of food.
Danish: Efavirenz/emtricitabin/tenofovirdisoproxil er ikke blevet vurderet sammen med mad.
English: INFORMATION IN BRAILLE Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Danish: INFORMATION I BRAILLESKRIFT Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
English: Tacrolimus/Emtricitabine/Tenofovir disoproxil (0.1 mg/kg q.d./200 mg/245 mg q.d.)
Danish: Tacrolimus/emtricitabin/tenofovirdiso proxil (0,1 mg/ kg q.d./ 200 mg/ 245 mg q.d.)