FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no clinical signs or symptoms suggestive of adrenal or gonadal dysfunction in adults.
Icelandic: Engin klínísk merki eða einkenni komu fram um skerta nýrna- eða kynkirtlastarfsemi.
English: The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and OATP1B3.
Icelandic: Starfsemi OATP1B1 og OATP1B3 getur haft áhrif á dreifingu tenófóvír alafenamíðs í líkamanum.
English: Patients had a mean age of 45 years (range 23-72), 90% were male, 75% were White, and 19% were Black.
Icelandic: Meðalgildi aldurs sjúklinga var 45 ár (á bilinu 23−72), 90% voru karlkyns, 75% voru hvítir og 19% voru svartir.
English: 6 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products.
Icelandic: 6 Aukaverkun sem kom fram samkvæmt reynslu eftir markaðssetningu lyfja sem innihalda tenófóvír alafenamíð.
English: No new adverse reactions were identified through Week 96 in 2 clinical studies of virologically suppressed patients who switched from emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) to Odefsey (Study GS-US-366-1216) or from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) to Odefsey (Study GS-US-366-1160).
Icelandic: 96 í 2 klínískum lyfjarannsóknum á veirufræðilega bældum sjúklingum sem skiptu úr emtrícítabíni/rilpiviríni/tenófóvír tvísóproxíl fúmarati (FTC/RPV/TDF) yfir í Odefsey (rannsókn GS-US-366-1216) eða úr efavírenzi/emtrícítabíni/tenófóvír tvísóproxíl fúmarati (EFV/FTC/TDF) yfir í Odefsey (rannsókn GS-US-366-1160).
English: In a study of virologically suppressed patients switching from EFV/FTC/TDF to Odefsey (Study GS-US-366-1160), decreases from baseline were observed in the fasting values of total cholesterol and HDL-cholesterol in the Odefsey arm; no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio, direct LDL-cholesterol or triglycerides were observed in either treatment arm at Week 96.
Icelandic: Í rannsókn á veirufræðilega bældum sjúklingum sem skiptu úr EFV/FTC/TDF yfir í Odefsey (rannsókn GS-US-366-1160), varð vart við lækkun fastandi gilda frá grunngildum fyrir heildarkólesteról og HDL-kólesteról í Odefsey arminum; í hvorugum arminum varð vart við klínískt marktækar breytingar frá grunngildum á miðgildi fastandi heildarkólesteróls miðað við hlutfall HDL-kólesteróls, LDL-kólesteról eða þríglýseríð í viku 96.
English: These medicines can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in your blood.
Icelandic: Þessi lyf geta hækkað magn rilpiviríns og tenófóvír alafenamíðs (innihaldsefni Odefsey) í blóðinu.
English: If you accidentally take more than the recommended dose of Odefsey you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Icelandic: Ef notaður er í ógáti meiri en ráðlagður skammtur af Odefsey er hugsanlegt að þú finnir fyrir aukaverkunum með lyfinu (sjá kafla 4 Hugsanlegar aukaverkanir).
English: clarithromycin erythromycin These medicines can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in your blood.
Icelandic: klaritrómycín erytrómycín Þessi lyf geta aukið magn rilpiviríns og tenófóvír alafenamíðs (innihaldsefni Odefsey) í blóðinu.
English: 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).
Icelandic: 10 ný tilvik um veirufræðilegan brest milli fyrstu greiningu í viku 48 og viku 96 (3 sjúklingar með ≤100.000 eintök/ml veirumagn við grunnlínu og 7 sjúklingar með >100.000 eintök/ml veirumagn við grunnlínu).
English: 0.7% (95% CI: -4.3% to 5.8%)
Icelandic: 0,7% (95% CI: -4,3% til 5,8%)
English: Patients had a mean age of 48 years (range 19-76), 87% were male, 67% were White, and 27% were Black.
Icelandic: Meðalgildi aldurs sjúklinga var 48 ára (á bilinu 19−76), 87% voru karlkyns, 67% voru hvítir og 27% voru svartir.
English: The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Icelandic: Tenófóvír alafenamíð sýndi veiruhamlandi áhrif í frumurækt gagnvart öllum HIV-1 flokkum (M, N og O), m.a. undirgerðum A, B, C, D, E, F og G (EC50 gildi voru á bilinu 0,10 til 12,0 nM) og sýndi virkni gegn HIV-2 (EC50 gildi voru á bilinu 0,91 til 2,63 nM).
English: In open-label Study GS-US-292-1249, the efficacy and safety of E/C/F/TAF were evaluated in adult patients co-infected with HIV-1 and chronic hepatitis B. Sixty-nine of the 72 patients were on prior TDF-containing antiretroviral therapy.
Icelandic: Í opinni rannsókn GS-US-292-1249 voru verkun og öryggi E/C/F/TAF metin hjá fullorðnum sjúklingum sem eru samhliða sýktir af HIV-1 og langvinnri lifrarbólgu B. Sextíu og níu af sjúklingunum
English: • If you are currently taking any of the following medicines: - carbamazepine, oxcarbazepine, phenobarbital and phenytoin (used to treat epilepsy and prevent seizures) - rifabutin, rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis)
Icelandic: Ef þú notar eitthvert eftirfarandi lyfja: karbamazepín, oxkarbazepín, fenóbarbítal og fenýtóín (notuð við meðferð flogaveiki og til að koma í veg fyrir köst) rifabútín, rifampicín og rifapentín (notuð við meðferð sumra bakteríusýkinga svo sem berkla)
English: These are medicinal products within class where similar interactions could be predicted.
Icelandic: Þetta eru lyf í sama flokki þar sem búist er við svipuðum milliverkunum.
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine + tenofovir alafenamide, given with elvitegravir + cobicistat as a fixed-dose combination tablet (see section 5.2).
Icelandic: Engin ný öryggisvandamál komu fram hjá sjúklingum með nýrnasjúkdóm á lokastigi sem voru í langvarandi blóðskilun og fengu emtrícítabín + tenófóvír alafenamíð samhliða elvitegravíri + kóbísistati sem samsetta töflu með föstum skammti (sjá kafla 5.2).
English: Other types of medicine:
Icelandic: Rannsóknir á öðrum lyfjum
English: 2 This adverse reaction was not observed in the Phase 3 studies of emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat or in the Phase 3 studies with Odefsey but identified from clinical studies or post-marketing experience of emtricitabine when used with other antiretrovirals.
Icelandic: 2 Ekki varð vart við þessa aukaverkun í 3. stigs klínísku lyfjarannsóknunum á emtrícítabíni + tenófóvír alafenamíði ásamt elvitegravíri + kóbísistati eða í 3. stigs rannsóknum
English: Through Week 96, in patients who switched to Odefsey from emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) or efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) (Studies GS-US-366-1216 and GS-US-366-1160; n = 754), no treatment-emergent resistance-associated mutations were detected.
Icelandic: 96 komu engar meðferðartengdar stökkbreytingar tengdar ónæmi fram hjá sjúklingum sem skiptu yfir í Odefsey úr emtrícítabíni/rilpiviríni/tenófóvír tvísóproxíl fúmarati (FTC/RPV/TDF) eða efavírenzi/emtrícítabíni/tenófóvír tvísóproxíl fúmarati (EFV/FTC/TDF) (rannsóknir GS-US-366-1216 og GS-US-366-1160; n = 754).
English: Simeprevir (150 mg once daily)/ Rilpivirine
Icelandic: Simeprevír (150 mg einu sinni á dag)/rilpivirín
English: There are no adequate and well-controlled studies of Odefsey or its components in pregnant women.
Icelandic: Engar fullnægjandi rannsóknir með góðum samanburði hafa verið framkvæmdar með Odefsey eða efnisþáttum þess á meðgöngu.
English: No Grade 3-4 laboratory abnormalities for AST/ALT or Grade 3-4 adverse reactions of transaminase increased were reported (see section 5.1).
Icelandic: Ekki var tilkynnt um neinar óeðlilegar rannsóknarniðurstöður af 3-4 stigi fyrir AST/ALT eða aukaverkanir af 3.-4.
English: No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min) in a Phase 1 study of tenofovir alafenamide.
Icelandic: Ekki varð vart við neinn klínískt marktækan mun á lyfjahvörfum tenófóvír alafenamíðs eða tenófóvírs hjá heilbrigðum einstaklingum og hjá sjúklingum með alvarlega skerta nýrnastarfsemi (áætluð kreatínínúthreinsun ≥ 15 ml/mín. og <30 ml/mín.)
English: Studies conducted with other medicinal products Based on drug-drug interaction studies conducted with the components of Odefsey, no clinically significant interactions are expected when Odefsey is combined with the following medicinal products: buprenorphine, naloxone and norbuprenorphine.
Icelandic: Odefsey er ekki búist við klínískt marktækum milliverkunum þegar Odefsey er gefið með eftirfarandi lyfjum: búprenorfín, naloxón og norbúprenorfín.
English: Small improvements in BMD were noted at 48 weeks after switching to E/C/F/TAF compared to maintaining the tenofovir disoproxil fumarate-containing regimen.
Icelandic: 48 eftir að skipt var yfir í E/C/F/TAF samanborið við það þegar meðferðaráætlun með tenófóvír tvísóproxíl fúmarati var haldið áfram.
English: General disorders and administration site conditions Common:
Icelandic: Almennar aukaverkanir og ástand tengt íkomustað Algengar:
English: The safety and efficacy of Odefsey in patients with significant underlying liver disorders have not been established.
Icelandic: Odefsey hjá sjúklingum með umtalsverða undirliggjandi kvilla í lifur hafa ekki verið staðfest.
English: Antacids (e.g., aluminium or magnesium hydroxide, calcium carbonate)
Icelandic: SÝRUBINDANDI LYF Sýrubindandi lyf (t.d. ál- eða magnesíumhýdroxíð, kalsíumkarbónat)
English: Povidone
Icelandic: Povidón
English: headache1, 3, dizziness1, 3
Icelandic: ógleði1,3, hækkaður brisamýlasi1
English: increased total cholesterol (fasted)1, increased LDL-cholesterol (fasted)1
Icelandic: hækkað heildarkólesteról (fastandi)1, hækkað LDL-kólesteról (fastandi)1
English: In a separate Phase 1 study of emtricitabine alone, mean systemic emtricitabine exposure was higher in patients with severe renal impairment (estimated CrCl < 30 mL/min) (33.7 µg•h/mL) than in subjects with normal renal function (11.8 µg•h/mL).
Icelandic: Í annarri 1. stigs rannsókn þar sem eingöngu var gefið emtricitabín var meðaltal altækrar útsetningar fyrir emtricitabíni hærra hjá sjúklingum með alvarlega skerta nýrnastarfsemi (áætluð kreatínínúthreinsun <30 ml/mín.)
English: In Study GS-US-292-0109, switching from a tenofovir disoproxil fumarate-based regimen to E/C/F/TAF was superior in maintaining HIV-1 RNA < 50 copies/mL compared to staying on the baseline regimen.
Icelandic: Í rannsókn GS-US-292-0109, reyndist betur að skipta úr meðferðaráætlun byggðri á tenófóvír tvísóproxíl fúmarati yfir í E/C/F/TAF til að viðhalda HIV-1 RNA <50 eintök/ml samanborið við þegar samanburðarmeðferð var haldið áfram.
English: decreased white blood cell count1, decreased haemoglobin1, decreased platelet count1
Icelandic: fækkun hvítra blóðkorna1, lækkað hemóglóbín1, fækkun blóðflagna1
English: Antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Rilpivirine
Icelandic: Ledipasvír/sófosbúvír (90 mg/400 mg einu sinni á dag)/rilpivirín
English: 3 Adverse reactions identified from clinical studies of emtricitabine + tenofovir alafenamide-containing products.
Icelandic: 3 Aukaverkun sem kom fram í klínískum lyfjarannsóknum á lyfjum sem innihalda emtrícítabín + tenófóvír alafenamíð.
English: 4 Adverse reaction identified through post-marketing surveillance of emtricitabine/rilpivirine/tenofovir disoproxil fumarate.
Icelandic: 4 Aukaverkun sem kom fram samkvæmt reynslu eftir markaðssetningu á emtrícítabíni/rilpiviríni/tenófóvír tvísóproxíl fúmarati.
English: At Week 96, switching to Odefsey was non-inferior in maintaining HIV-1 RNA < 50 copies/mL when compared to patients who stayed on FTC/RPV/TDF or on EFV/FTC/TDF in respective studies.
Icelandic: RNA < 50 eintök/ml samanborið við sjúklinga sem voru áfram á FTC/RPV/TDF eða á EFV/FTC/TDF í hvorri rannsókn.
English: FTC/TDF + rilpivirine hydrochloride was non-inferior in achieving HIV-1 RNA < 50 copies/mL compared to FTC/TDF + efavirenz.
Icelandic: FTC/TDF + rilpivirín hýdróklóríð verkun var ekki lakari í að ná fram HIV-1
English: There are no pharmacokinetic data on emtricitabine or tenofovir alafenamide in patients with end stage renal disease (estimated CrCl < 15 mL/min) not on chronic haemodialysis.
Icelandic: Engar upplýsingar liggja fyrir um lyfjahvörf emtrícítabíns eða tenófóvír alafenamíðs hjá sjúklingum með nýrnasjúkdóm á lokastigi (áætluð kreatínínúthreinsun < 15 ml/mín.)
English: The safety of emtricitabine + tenofovir alafenamide was evaluated through 48 weeks in a single arm, open-label clinical study (GS-US-292-1825) in which 55 virologically suppressed HIV-1 infected patients with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Icelandic: Öryggi emtrícítabíns + tenófóvír alafenamíðs var metið í 48 vikur í einarma, opinni, klínískri lyfjarannsókn (GS-US-292-1825) þar sem 55 veirufræðilega bældir sjúklingar með HIV-1 sýkingu og nýrnasjúkdóm á lokastigi (eGFRCG < 15 ml/mín.)
English: On days of haemodialysis, Odefsey should be administered after completion of haemodialysis treatment.
Icelandic: Á blóðskilunardögunum skal gefa Odefsey eftir að blóðskilun er lokið.
English: In the pooled Phase 3 TMC278-C209 and TMC278-C215 studies of treatment-naïve patients, at Week 96, there was an overall mean change from baseline in basal cortisol of -19.1 (-30.85; -7.37) nmol/L in the rilpivirine arm and of -0.6 (-13.29; 12.17) nmol/L in the efavirenz arm. At Week 96, the mean change from baseline in ACTH-stimulated cortisol levels was lower in the rilpivirine arm (+18.4 ± 8.36 nmol/L) than in the efavirenz arm (+54.1 ± 7.24 nmol/L).
Icelandic: Í sameinuðum upplýsingum úr 3. stigs rannsóknunum TMC278-C209 og TMC278-C215 hjá áður ómeðhöndluðum sjúklingum, í viku 96, var breyting á heildarmeðaltali frá grunngildi grunnkortísóls -19,1 (-30,85; -7,37) nmól/l í rilpivirín arminum og -0,6 (-13,29; 12,17) nmól/l í efavírenz arminum.
English: The mutations associated with NRTI resistance that developed in 3 or more patient isolates were: K65R, K70E, M184V/I and K219E.
Icelandic: K65R, K70E, M184V/I og K219E.
English: In a study of virologically suppressed patients switching from FTC/RPV/TDF to Odefsey (Study GS-US-366-1216), increases from baseline were observed in fasting values of total cholesterol, direct LDL-cholesterol, HDL-cholesterol, and triglycerides in the Odefsey arm; and no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio were observed in either treatment arm at Week 96.
Icelandic: Í rannsókn á veirufræðilega bældum sjúklingum sem skiptu úr FTC/RPV/TDF yfir í Odefsey (rannsókn GS-US-366-1216), varð vart við aukningu frá grunngildi hvað varðar fastandi heildarkólesteról, LDL-kólesteról, HDL-kólesteról og þríglýseríð í Odefsey arminum; og í hvorugum arminum varð vart við klínískt marktækar breytingar frá grunngildum á miðgildi fastandi heildarkólesteróls miðað við hlutfall HDL-kólesteróls í viku
English: If a patient vomits more than 4 hours after taking Odefsey they do not need to take another dose of Odefsey until the next regularly scheduled dose.
Icelandic: eftir að Odefsey er tekið þarf ekki að taka annan skammt af Odefsey fyrr en kemur að næsta venjulega skammti.
English: By baseline viral load (copies/mL)
Icelandic: Eftir grunngildi veirumagns (eintök/ml)
English: Inhibition of P-gp
Icelandic: P-gp hemlun
English: rash1, 3
Icelandic: útbrot1,3
English: No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, rilpivirine or tenofovir alafenamide.
Icelandic: Ekki hefur komið í ljós marktækur klínískt mikilvægur mismunur á lyfjahvörfum emtrícítabíns, rilpiviríns eða tenófóvír alafenamíðs sem rekja má til aldurs, kyns eða kynþáttar.
English: The safety of emtricitabine + tenofovir alafenamide was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112), in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Icelandic: Öryggi emtrícítabín + tenófóvír alafenamíð var metið í 144 vikur í opinni klínískri lyfjarannsókn (GS-US-292-0112) hjá 248 HIV-1 sýktum sjúklingum, sem höfðu annaðhvort ekki fengið meðferð áður (n = 6) eða voru veirufræðilega bældir (n = 242) með vægt eða miðlungs skerta nýrnastarfsemi (áætlaður gauklasíunarhraði með Cockcroft-Gault aðferð [eGFRCG]:
English: If you vomit less than 4 hours after taking Odefsey, take another tablet with food.
Icelandic: eftir að Odefsey er tekið skal taka aðra töflu með mat.
English: The combination of Odefsey with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Icelandic: Odefsey og þessara makrólíðasýklalyfja getur valdið hækkun á plasmaþéttni rilpiviríns (CYP3A hemlun) og tenófóvír alafenamíðs (P-gp hemlun).
English: Paracetamol (500 mg single dose)/ Rilpivirine1
Icelandic: VERKJALYF Parasetamól (500 mg stakur skammtur)/rilpivirín1
English: Co-administration of Odefsey and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine which could potentially lead to loss of virologic response to Odefsey (see section 4.3) and possible resistance to rilpivirine and to the NNRTI class.
Icelandic: Sýnt hefur verið fram á að samtímis gjöf Odefsey með lyfjum sem örva CYP3A lækkar plasmaþéttni rilpiviríns sem gæti leitt til minni veirusvörunar við Odefsey (sjá kafla 4.3) og hugsanlegs ónæmis gagnvart rilpiviríni og NNRTI flokki lyfja.
English: Ketoconazole (400 mg once daily)/ Rilpivirine1
Icelandic: Ketókónazól (400 mg einu sinni á dag)/rilpivirín1
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin (40 mg once daily)/ Rilpivirine1
Icelandic: REDÚKTASAHEMLAR Atorvastatín (40 mg einu sinni á dag)/rilpivirín1
English: Emtricitabine:
Icelandic: Ómeprazól:
English: Odefsey should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
Icelandic: Odefsey þegar það er gefið samtímis lyfjum sem vitað er að geta valdið margbreytilegum sleglahraðtakti (Torsade de Pointes).
English: The antiviral activity of tenofovir alafenamide against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells,
Icelandic: Áhrif tenófóvír alafenamíðs gegn HIV-1 rannsóknarstofustofnum af undirgerð B og stofnum einangruðum úr sjúklingum voru metin í frumulínum eitilkímfrumna, einkjarna blóðfrumum, einkyrningum/átfrumum og CD4+ T-eitilfrumum.
English: Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1
Icelandic: Famótidín (40 mg stakur skammtur tekinn 12 klst. á undan rilpiviríni)/rilpivirín1
English: • Antifungal medicines used to treat fungal infections:
Icelandic: Sveppalyf notuð til að meðhöndla sveppasýkingar:
English: Co-administration is likely to cause significant decreases in the plasma concentrations of tenofovir alafenamide (induction of P-gp).
Icelandic: Líklegt er að samtímis gjöf valdi mikilli lækkun á plasmaþéttni tenófóvír alafenamíðs (P-gp örvun).
English: abdominal pain1, 3, vomiting1, 3, increased lipase1, abdominal discomfort1, dry mouth1, flatulence3, diarrhoea3
Icelandic: kviðverkur1,3, uppköst1,3, hækkaður lípasi1, óþægindi í kvið1, munnþurrkur1, vindverkir3, niðurgangur3
English: In Study GS-US-292-1825, the efficacy and safety of E/C/F/TAF were evaluated in a single arm, open-label clinical study in which 55 HIV-1 infected adults with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis for at least 6 months before switching to E/C/F/TAF FDC tablet.
Icelandic: Í rannsókn GS-US-292-1825 voru verkun og öryggi E/C/F/TAF metin í einarma, opinni, klínískri lyfjarannsókn hjá 55 HIV-1 sýktum fullorðnum einstaklingum með nýrnasjúkdóm á lokastigi (eGFRCG < 15 ml/mín.)
English: Co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH).
Icelandic: Samtímis gjöf getur valdið mikilli lækkun á plasmaþéttni rilpiviríns (minna frásog, hækkað pH-gildi í maga).
English: Liver toxicity associated with liver enzyme induction was observed in rodents.
Icelandic: Vart hefur orðið við eiturverkun í lifur hjá nagdýrum sem tengist aðleiðslu (induction) lifrarensíma.
English: Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median EC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/mL).
Icelandic: í T-frumulínu með bráða sýkingu með 0,73 nM (0,27 ng/ml) miðgildi EC50 fyrir HIV-1/IIIB.
English: Rifabutin (300 mg once daily)/ Rilpivirine
Icelandic: Rifabútín (300 mg einu sinni á dag)/rilpivirín
English: • Any medicines used for treating HIV • Any medicines containing:
Icelandic: Einhver lyf notuð til að meðhöndla alnæmisveiru (HIV) •
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily)/ Rilpivirine2
Icelandic: Sófosbúvír/velpatasvír (400 mg/100 mg einu sinni á dag)/rilpivírín2
English: Exposures of emtricitabine and tenofovir in 12 patients with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis who received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet (E/C/F/TAF) in Study GS-US-292-1825 were significantly higher than in patients with normal renal function.
Icelandic: sem voru í langvarandi blóðskilun og fengu emtrícítabín + tenófóvír alafenamíð samhliða elvitegravíri + kóbísistati sem samsetta töflu með föstum skammti (E/C/F/TAF) í rannsókn GS-US-292-1825 var marktækt hærri en hjá sjúklingum með eðlilega nýrnastarfsemi.
English: CYP enzyme inhibitors
Icelandic: CYP-ensím hemlar
English: severe skin reactions with systemic symptoms4, angioedema5, 6, pruritus3, urticaria6 Musculoskeletal and connective tissue disorders Uncommon:
Icelandic: alvarleg viðbrögð í húð með altækum einkennum4, ofsabjúgur5,6, ofsakláði3, ofsakláði6
English: Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1 to 2 hours post-dose.
Icelandic: Emtrícítabín frásogast hratt og vel eftir gjöf til inntöku og hámarksstyrkur í blóðvökva verður 1 til 2 klst.
English: Significant decreases in rilpivirine plasma concentrations are expected (reduced absorption, increase in gastric pH).
Icelandic: Gert er ráð fyrir umtalsverðri lækkun á plasmaþéttni rilpiviríns (minna frásog, hækkað pH-gildi í maga).
English: HIV-1 RNA < 20 copies/mL Treatment difference
Icelandic: RNA <20 eintök/ml
English: 102.4 (38.9)b
Icelandic: 102,4 (38,9)b Á ekki við 10,0 (19,6)
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 activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 µM).
Icelandic: Gildi 50% hrifstyrks (EC50) emtrícítabíns voru á bilinu 0,0013 til 0,64 µM. Emtrícítabín sýndi áhrif gegn veirum í frumurækt gagnvart HIV-1 undirgerðum A, B, C, D, E, F og G (EC50 gildi voru á bilinu 0,007 til 0,075 µM) og virkni gegn HIV-2 (EC50 gildi voru á bilinu 0,007 til 1,5 µM).)
English: The mean baseline CD4+ cell count was 697 cells/mm3 (range
Icelandic: Meðalgildi CD4+ frumutalningar við grunngildi var 700 frumur/mm3 (á bilinu