FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of EVOTAZ with medicinal products that inhibit CYP3A may decrease the clearance of atazanavir and cobicistat, resulting in increased atazanavir and cobicistat plasma concentrations (see section 4.5).
Icelandic: Samhliða gjöf EVOTAZ og lyfja sem hamla CYP3A getur dregið úr úthreinsun atazanavirs og cobicistats, og aukið þannig plasmaþéttni atazanavirs og cobicistats (sjá kafla 4.5).
English: The mechanism of interaction is inhibition of CYP3A4 and/or CYP2D6 by atazanavir and/or cobicistat.
Icelandic: Verkunarháttur milliverkunar er hömlun CYP3A4 og/eða CYP2D6 af völdum atazanavirs og/eða cobicistats.
English: Atazanavir should be used with caution in patients with mild (Child-Pugh Class A) hepatic impairment.
Icelandic: Gæta skal varúðar við notkun atazanavirs hjá sjúklingum með vægt skerta lifrarstarfsemi (Child-Pugh Class A).
English: If you feel dizzy or lightheaded, please contact your doctor immediately.
Icelandic: Ef þú finnur fyrir sundli eða svima skaltu tafarlaust hafa samband við lækninn.
English: Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Icelandic: Ólíkt ritonaviri er cobicistat ekki CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eða UGT1A1 virkir.
English: INHALED BETA AGONISTS Salmeterol
Icelandic: BETA ADRENVIRK LYF TIL INNÖNDUNAR Salmeterol
English: Clinical monitoring of therapeutic effect and adverse events is recommended when these medicinal products are co-administered with EVOTAZ.
Icelandic: Klínískt eftirlit með verkun og aukaverkunum er ráðlagt þegar þessi lyf eru gefin samhliða EVOTAZ.
English: Famotidine 20 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily) in HIV-infected patients
Icelandic: Famotidin 20 mg tvisvar á dag (atazanavir 300 mg/ritonavir 100 mg einu sinni á dag) hjá sjúklingum með HIV-smit
English: If overdose occurs with EVOTAZ, the patient must be monitored for evidence of toxicity.
Icelandic: EVOTAZ verður að fylgjast með sjúklingnum með tilliti til vísbendinga um eiturverkun.
English: EVOTAZ is expected to increase rilpivirine plasma concentrations.
Icelandic: Gert er ráð fyrir að EVOTAZ auki plasmaþéttni rilpivirins.
English: Integrase Inhibitors
Icelandic: Integrasa hemlar
English: If the patient has developed SJS or DRESS associated with the use of EVOTAZ, EVOTAZ may not be restarted.
Icelandic: Ef Stevens-Johnson heilkenni eða lyfjaútbrot með eósínfíklafjöld og altækum einkennum (DRESS heilkenni) sem tengist notkun EVOTAZ koma fram á ekki að hefja notkun EVOTAZ á ný.
English: Pravastatin is not metabolised by CYP3A4.
Icelandic: Pravastatin umbrotnar ekki fyrir tilstilli CYP3A4.
English: Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients receiving atazanavir.
Icelandic: Greint hefur verið frá Stevens-Johnson heilkenni, regnbogaroðasótt (erythema multiforme), eitrunarútbrotum og lyfjaútbrotum með eósínfíklafjöld og altækum einkennum (DRESS heilkenni) hjá sjúklingum sem fá atazanavir.
English: Amlodipine Felodipine Nicardipine Nifedipine Verapamil
Icelandic: Felodipin Nicardipin
English: Some patients have reported dizziness when taking atazanavir or cobicistat, active substances of EVOTAZ.
Icelandic: Nokkrir sjúklingar hafa greint frá sundli meðan á töku atazanavirs eða cobicistats, sem eru virku efnin í EVOTAZ, stóð.
English: HMG-CoA reductase inhibitors
Icelandic: HMG-CoA redúktasahemlar
English: Of these 692 patients, 613 (300 atazanavir with cobicistat and 313 atazanavir with ritonavir) and 496 (250 atazanavir with cobicistat and 246 atazanavir with ritonavir) received at least 48 and 144 weeks of treatment, respectively.
Icelandic: 48 vikur (300 atazanavir ásamt cobicistati og 313 atazanaviri ásamt ritonaviri) og 496 í a.m.k.
English: EVOTAZ or any other medicinal product containing atazanavir should be discontinued if severe rash develops.
Icelandic: EVOTAZ eða hvaða lyfs sem er sem inniheldur atazanavir ef veruleg útbrot koma fram.
English: Cobicistat is a strong mechanism-based CYP3A inhibitor and is a CYP3A substrate.
Icelandic: Cobicistat er öflugur CYP3A hemill háður verkunarhætti og er CYP3A hvarfefni.
English: Atazanavir plasma concentrations may decrease as a consequence of a reduction in cobicistat plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Icelandic: Dregið getur úr plasmaþéttni atazanavirs sem afleiðing af minnkaðri plasmaþéttni cobicistats sem getur leitt til taps á verkun og þróun ónæmis.
English: Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mle
Icelandic: Hætt að nota rannsóknarlyf af öðrum ástæðum og síðasta fyrirliggjandi HIV-1
English: Cobicistat is not expected to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9 or CYP2C19.
Icelandic: Ekki er gert ráð fyrir að cobicistat hamli CYP1A2, CYP2B6, CYP2C8, CYP2C9 eða CYP2C19.
English: A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Icelandic: Rannsókn á lyfjahvörfum cobicistats var gerð á einstaklingum með meðalskerta lifrarstarfsemi (Child-Pugh flokkur B), sem ekki voru með HIV-1 sýkingu.
English: Data are not available to make recommendations regarding the use of EVOTAZ with other oral contraceptives.
Icelandic: Upplýsingar eru ekki fyrirliggjandi fyrir ráðleggingar um notkun EVOTAZ með öðrum getnaðarvarnarlyfjum til inntöku.
English: Atazanavir and cobicistat are metabolised by the hepatic system.
Icelandic: Atazanavir og cobicistat umbrotna í lifur.
English: Co-administration of salmeterol with EVOTAZ is not recommended (see section 4.4).
Icelandic: Samhliða gjöf salmeterols og EVOTAZ er ekki ráðlögð (sjá kafla 4.4).
English: In clinical studies, atazanavir has been shown to induce dyslipidaemia to a lesser extent than comparators.
Icelandic: Sýnt hefur verið fram á í klínískum rannsóknum að atazanavir valdi minni blóðfituvandamálum en samanburðarlyf.
English: If you notice any of these symptoms please inform your doctor.
Icelandic: Ef þessi einkenni koma fram skaltu láta lækninn vita.
English: Telaprevir 750 mg three times daily (atazanavir/ritonavir 300/100 mg once daily)
Icelandic: Telaprevir 750 mg þrisvar á dag (atazanavir/ritonavir 300/100 mg einu sinni á dag)
English: It is unknown if cobicistat/metabolites are excreted in human milk.
Icelandic: Ekki er þekkt hvort cobicistat/umbrotsefni skiljist út í brjóstamjólk.
English: In treatment-naïve HIV-1 infected patients
Icelandic: Sjúklingar með HIV-1 sem hafa ekki fengið meðferð áður
English: Renal impairment Atazanavir
Icelandic: Skert nýrnastarfsemi Atazanavir
English: MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Icelandic: Markaðsleyfishafi Bristol-Myers Squibb Pharma EEIG
English: When co-administering tenofovir alafenamide/emtricitabine and EVOTAZ, the recommended dose of tenofovir alafenamide/emtricitabine is 10/200 mg once daily.
Icelandic: Z er ráðlagður skammtur tenofovir alafenamids/emtricitabins 10/200 mg einu sinni á dag.
English: No meaningful differences in cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects, consistent with low renal clearance of cobicistat.
Icelandic: Ekki varð vart við marktækan mun á lyfjahvörfum cobicistats hjá einstaklingum með verulega skerta nýrnastarfsemi og heilbrigðum einstaklingum sem er í samræmi við litla úthreinsun cobicistats um nýru.
English: Atazanavir is primarily hepatically metabolised and increased plasma concentrations were observed in patients with hepatic impairment (see sections 4.2 and 5.2).
Icelandic: Atazanavir umbrotnar aðallega í lifur og aukin þéttni í plasma kom í ljós hjá sjúklingum með skerta lifrarstarfsemi (sjá kafla 4.2 og 5.2).
English: Table 1: Interactions between EVOTAZ and other medicinal products Medicinal products by therapeutic area
Icelandic: Milliverkanir milli EVOTAZ og annarra lyfja
English: Co-administration of EVOTAZ with glecaprevir/pibrentasvir fixed dose combination is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3).
Icelandic: Ekki má nota EVOTAZ ásamt glecaprevir/pibrentasvir fastri skammtasamsetningu vegna hugsanlega aukinnar hættu á ALAT hækkun vegna verulegrar aukningar á plasmaþéttni glecaprevirs og pibrentasvirs (sjá kafla 4.3).
English: PULMONARY ARTERIAL HYPERTENSION
Icelandic: Blóðþrýstingslækkandi lyf
English: Skin and subcutaneous tissue disorders common rash uncommon pruritus, erythema multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia rare
Icelandic: Húð og undirhúð algengar útbrot sjaldgæfar kláði, regnbogaroðasótta,b, eitrunarútbrot í húða,b, lyfjaútbrot með eósínfíklafjöld og altækum einkennum
English: These medicinal products include alfuzosin, amiodarone, astemizole, bepridil, cisapride, colchicine, dronedarone, ergot deriviatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine), lovastatin, orally administered midazolam, pimozide, quetiapine, quinidine, lurasidone, simvastatin, sildenafil (when used to treat pulmonary arterial hypertension), avanafil, systemic lidocaine, ticagrelor, terfenadine and triazolam.
Icelandic: Þetta eru m.a. alfuzosin, amiodaron, astemizol, bepridil, cisaprið, colchicin, dronedaron, ergotafleiður (t.d. dihydroergotamin, ergometrin, ergotamin, methylergonovin), lovastatin, midazolam til inntöku, pimozið, quetiapin, kínidín, lurasidon, simvastatin, sildenafil (þegar það er notað við lungnaháþrýstingi) avanafil, lidocain til altækrar notkunar, ticagrelor, terfenadin og triazolam.
English: The mechanism of interaction is CYP3A4 and P-gp inhibition by cobicistat.
Icelandic: Verkunarháttur milliverkunar er CYP3A4 og P-gp hömlun af völdum cobicistats.
English: The mechanism of interaction is inhibition of CYP2D6 by cobicistat.
Icelandic: Verkunarháttur milliverkunar er CYP2D6 hömlun af völdum cobicistats.
English: No dose adjustment of cobicistat is required in patients with mild or moderate hepatic impairment.
Icelandic: Ekki þarf að aðlaga skammta cobicistats hjá sjúklingum með vægt eða meðalskerta lifrarstarfsemi.
English: AUC: ↑24% (↑21% ↑28%) Cmax: ↑14% (↑8% ↑20%) Cmin: ↑22% (↑15% ↑30%)
Icelandic: ↑24% (↑21% ↑28%) Cmax: ↑14% (↑8% ↑20%) Cmin:
English: Cobicistat is a CYP3A substrate and is metabolised to a minor extent by CYP2D6.
Icelandic: Cobicistat er CYP3A hvarfefni og umbrotnar að litlu leyti af völdum CYP2D6.
English: EVOTAZ must not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Icelandic: EVOTAZ á ekki að nota ásamt lyfjum sem eru hvarfefni CYP3A4 og hafa þröngt læknanlegt bil.
English: Moderate to severe hepatic impairment.
Icelandic: Meðalskert og verulega skert lifrarstarfsemi.
English: No significant effect on atazanavir concentrations was observed.
Icelandic: Engin marktæk áhrif á þéttni atazanavirs kom í ljós.
English: There is a risk of loss of therapeutic effect and development of resistance to atazanavir (see section 4.3).
Icelandic: Hætta er á verkunarleysi og myndun ónæmis gegn atazanaviri (sjá kafla 4.3).
English: Other medicines and EVOTAZ
Icelandic: Notkun annarra lyfja samhliða EVOTAZ
English: EVOTAZ should not be initiated in patients with creatinine clearance less than 70 ml/min if one or more co-administered agent requires dose adjustment based on creatinine clearance (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir; see sections 4.2, 4.8 and 5.2).
Icelandic: ef það er gefið samhliða einu eða fleiri lyfjum sem krefjast skammtaaðlögunar með tilliti til kreatínínúthreinsunar (t.d. emtricitabin, lamivudin, tenofovir disoproxil eða adefovir, sjá kafla 4.2, 4.8 og 5.2).
English: Atazanavir increases tenofovir concentrations.
Icelandic: Atazanavir eykur þéttni tenofovirs.
English: Co-administration of EVOTAZ with these medicinal products is expected to substantially increase their concentrations and may result in PDE5-associated adverse reactions such as hypotension, visual changes and priapism (see section 4.5).
Icelandic: Gert er ráð fyrir að samhliða gjöf EVOTAZ og þessara lyfja auki þéttni þeirra verulega og geti valdið aukaverkunum sem tengjast PDE5 t.d.lágum blóðþrýstingi, breytingu á sjón og sístöðu getnaðarlims (sjá kafla 4.5).
English: Complex or unknown mechanisms of drug interaction preclude extrapolation of ritonavir drug interactions to certain cobicistat drug interactions.
Icelandic: Samþættur eða óþekktur verkunarháttur milliverkunar útilokar að hægt sé að yfirfæra milliverkanir ritonavirs á ákveðnar milliverkanir fyrir cobicistat.
English: Co-administration of EVOTAZ with astemizole and terfenadine is contraindicated (see section 4.3).
Icelandic: Ekki á að gefa EVOTAZ samhliða astemizol og terfenadin (sjá kafla 4.3).
English: What you need to know before you take EVOTAZ 3.
Icelandic: Áður en byrjað er að nota EVOTAZ 3. Hvernig nota á EVOTAZ
English: Didanosine should be taken in the fasted state 2 hours after EVOTAZ taken with food.
Icelandic: Didanosin á að taka fastandi 2 klst.
English: Plasma concentrations of drospirenone are increased following co-administration of drospirenone/ethinyloestradiol with atazanavir/cobicistat.
Icelandic: Plasmaþéttni drospirenons eykst eftir samhliða gjöf drospirenons/ethinyloestradiols ásamt atazanavir/cobicistat.
English: Alternative antibiotics should be considered.
Icelandic: Hugleiða ætti notkun annarra sýklalyfja.
English: Particular caution should be used when prescribing EVOTAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors (bradycardia, long congenital QT, electrolyte imbalances (see sections 4.8 and 5.3).
Icelandic: Gæta skal sérstakrar varúðar þegar EVOTAZ er ávísað ásamt lyfjum sem geta hugsanlega aukið QT bil og /eða hjá sjúklingum sem eru með áhættuþætti fyrir (hægur hjartsláttur, meðfætt langt QT, truflun á blóðsaltajafnvægi (sjá kafla 4.8 og 5.3)).
English: INSTRUCTIONS ON USE
Icelandic: Leiðbeiningarnar í töflu
English: Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C. Co-infected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Icelandic: B eða C og af 655 sjúklingum sem fengu 300 mg atazanavir einu sinni á dag með 100 mg ritonavir einu sinni á dag voru 97 sjúklingar einnig með langvinna lifrarbólgu B eða C. Meiri líkur eru á transaminasahækkun hjá sjúklingum sem einnig eru með lifrarbólgu
English: b See section Description of selected adverse reactions for more details.
Icelandic: Sjá samantekt á eiginleikum REYATAZ fyrir frekari upplýsingar.
English: There are limited data from the use of EVOTAZ in pregnant women.
Icelandic: Takmarkaðar upplýsingar liggja fyrir um notkun EVOTAZ á meðgöngu.
English: Glecaprevir AUC : ↑553% Glecaprevir Cmax : ↑306% (↑215% Glecaprevir Cmin : ↑1330% (↑885% Pibrentasvir AUC : ↑64% (↑48% Pibrentasvir Cmax : ↑29% (↑15% Pibrentasvir Cmin: ↑129% (↑95% Atazanavir AUC : ↑11% (↑3% Atazanavir Cmax : ↔ 0% (↓ Atazanavir Cmin: ↑16% (↑7% * Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Icelandic: ↑129% (↑95% Atazanavir AUC : ↑11% (↑3% ↑19%) Atazanavir Cmax : ↔ 0% (↓ Atazanavir Cmin: ↑16% (↑7% ↑25%) * Tilkynnt hefur verið um áhrif atazanavirs og ritonavirs á fyrsta skammt glecaprevirs og pibrentasvirs.
English: Methadone, stable maintenance dose (atazanavir 400 mg once daily)
Icelandic: Methadon, stöðugur viðhaldsskammtur (atazanavir 400 mg einu sinni á dag)
English: The mechanism of interaction is CYP3A4 induction by rifampicin.
Icelandic: Verkunarháttur milliverkunar er CYP3A4 hömlun af völdum rifampicins.
English: ANTIBIOTICS Clarithromycin 500 mg twice daily (atazanavir 400 mg once daily)
Icelandic: Clarithromycin 500 mg tvisvar á dag (atazanavir 400 mg einu sinni á dag)
English: The demographic and baseline characteristics were similar between the atazanavir with cobicistat and atazanavir with ritonavir groups.
Icelandic: Lýðfræðileg einkenni og einkenni við upphaf voru svipuð hjá hópnum sem fékk atazanavir ásamt cobicistat og hópnum sem fékk atazanavir ásamt ritonaviri.
English: Omeprazole 40 mg once daily (atazanavir 400 mg once daily, 2 hours after omeprazole)
Icelandic: Omeprazol 40 mg einu sinni á dag (atazanavir 400 mg einu sinni á dag, 2 klst. á eftir omeprazol)
English: The combination of rifampicin and EVOTAZ is contraindicated (see section 4.3).
Icelandic: Ekki má nota rifampicin samhliða EVOTAZ (sjá kafla 4.3).
English: The mechanism of interaction is CYP3A4 induction by etravirine.
Icelandic: Verkunarháttur milliverkunar er CYP3A4 virkjun af völdum etravirins.
English: Co-administration of EVOTAZ with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Icelandic: Samhliða gjöf EVOTAZ og lyfja sem eru meðalöflugir eða vægir CYP3A virkjar geta dregið úr plasmaþéttni atazanavirs og/eða cobicistats og valdið því að áhrif tapast og hugsanlega þróun ónæmis gegn atazanaviri.
English: Co-administration of EVOTAZ with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (used to treat chronic hepatitis C infection) is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations and potential for the increase in risk of ALT elevations associated with the increase in grazoprevir concentrations (see section 4.3 and Table 1).
Icelandic: Ekki má gefa EVOTAZ samhliða lyfjum sem innihalda grazoprevir m.a. samsetningar með föstum elbasvir/grazoprevir skammti (notað við langvinnri lifrarbólgu C) vegna aukinnar þéttni grazoprevirs og elbasvirs í plasma og hugsanlega aukinni hættu á ALAT hækkun í tengslum við aukna þéttni grazoprevirs (sjá kafla 4.3 og töflu 1).
English: Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving EVOTAZ should be evaluated for alternative etiologies.
Icelandic: Hækkun á lifrartransamínösum sem verður við bilirúbínhækkun hjá sjúklingum þarf að meta vegna annarra orsaka.
English: Co-administration with antiretroviral medicinal products EVOTAZ is indicated for use with other antiretrovirals for the treatment of HIV-1 infection.
Icelandic: EVOTAZ er ætlað til notkunar ásamt öðrum andretróveirulyfjum til meðferðar á HIV-1 sýkingu.
English: In study GS-US-216-0114, through 144 weeks of treatment hyperbilirubinaemia (> 1 x ULN) was common: 97.7% in the atazanavir boosted with cobicistat plus emtricitabine and tenofovir DF fixed-dose combination group, and 97.4% in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir DF fixed-dose combination group.
Icelandic: 97,7% í hópnum sem fékk atazanavir örvað með cobicistati ásamt emtricitabini og tenofovir DF í fastri skammtasamsetningu og 97,4% í hópnum sem fékk atazanavir örvað með ritonaviri ásamt emtricitabini og tenofovir DF í fastri skammtasamsetningu meðan á 144 vikna meðferð stóð.
English: Metabolism and nutrition disorders common increased appetite uncommon weight decreased, weight gain, anorexia
Icelandic: Efnaskipti og næring algengar aukin matarlyst sjaldgæfar þyngdarminnkun, þyngdaraukning, lystarleysi
English: Co-administration with EVOTAZ has the potential to increase warfarin plasma concentrations.
Icelandic: Samhliða gjöf EVOTAZ getur hugsanlega aukið plasmaþéttni warfarins.
English: Diltiazem 180 mg once daily (atazanavir 400 mg once daily)
Icelandic: Diltiazem 180 mg einu sinni á dag (atazanavir 400 mg einu sinni á dag)
English: Co-administration of EVOTAZ with medicinal products containing ritonavir or cobicistat, which are strong inhibitors of CYP3A, may result in additional boosting and increased plasma concentration of atazanavir.
Icelandic: Samhliða gjöf EVOTAZ og lyfja sem innihalda ritonavir eða cobicistat sem eru öflugir CYP3A hemlar geta valdið viðbótar örvun og aukið plasmaþéttni atazanavirs.
English: Subjects with significant liver function test abnormalities generally had abnormal baseline transaminases (AST or ALT), underlying chronic or acute hepatitis B or C co-infection, concomitant hepatotoxic medications (e.g., isoniazid), or a medical history of alcoholism or alcohol abuse.
Icelandic: C sýkingu, samhliðameðferð með lyfjum sem hafa eituráhrif á lifur (t.d. isoniazið) eða sögu um áfengissýki eða misnotkun áfengis.
English: Co-administration of EVOTAZ with alfuzosin is contraindicated (see section 4.3)
Icelandic: Ekki á að gefa EVOTAZ ásamt alfuzosini (sjá kafla 4.3)
English: Co-administration of boceprevir and EVOTAZ is not recommended.
Icelandic: Samhliða gjöf boceprevirs og EVOTAZ er ekki ráðlögð.
English: Rosuvastatin (10 mg single dose) (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Icelandic: Rosuvastatin (10 mg stakur skammtur) (atazanavir 300 mg einu sinni á dag með cobicistat 150 mg einu sinni á dag)
English: Animal studies do not indicate direct or indirect harmful effects of cobicistat with respect to reproductive toxicity (see section 5.3).
Icelandic: Dýrarannsóknir benda hvorki til beinna né óbeinna skaðlegra áhrifa cobicistats á æxlun (sjá kafla 5.3).
English: Co-administration of EVOTAZ and indinavir is not recommended (see section 4.4).
Icelandic: Ekki er ráðlagt að gefa EVOTAZ samtímis indinaviri (sjá kafla 4.4).
English: Patients with co-existing conditions
Icelandic: Sjúklingar með aðra sjúkdóma
English: The mechanism of interaction is CYP3A4 and UGT1A1 inhibition by atazanavir.
Icelandic: Atazanavir er CYP3A4 og UGT1A1 hemill.
English: Gastrointestinal disorders very common nausea common vomiting, diarrhoea, dyspepsia, abdominal pain, abdominal distension, flatulence, dry mouth uncommon pancreatitis, gastritis, stomatitis aphthous
Icelandic: Meltingarfæri mjög algengar ógleði algengar uppköst, niðurgangur, meltingartruflanir, kviðverkir, þaninn kviður, uppþemba, munnþurrkur sjaldgæfar brisbólga, magabólga, sár í munni
English: Naloxone AUC: ↓28% Naloxone Cmax: ↓28%
Icelandic: ↓28% Naloxon Cmax:
English: The following statements reflect the preclinical safety results of the individual active substances of EVOTAZ.
Icelandic: Eftirfarandi endurspeglar niðurstöður úr forklínískum rannsóknum á öryggi fyrir hvort virkt innihaldsefni EVOTAZ fyrir sig.
English: In female mice, atazanavir exposure at a dose that produced single-cell necrosis was 12 times the exposure in humans given 400 mg once daily.
Icelandic: Þéttni atazanavirs í skömmtum sem ollu einstaka lifrarfrumudrepi hjá kvenmúsum var 12 sinnum meiri en í mönnum við 400 mg sólarhringsskammt.
English: Cobicistat is a weak CYP2D6 inhibitor and is metabolised to a minor extent by CYP2D6.
Icelandic: Cobicistat er vægur CYP2D6 hemill og umbrotnar að örlitlu leyti fyrir tilstilli CYP2D6.
English: Elbasvir concentrations were increased when co-administered with atazanavir/ritonavir
Icelandic: Þéttni elbasvirs jókst þegar það ar gefið samhliða atazanaviri/ritonaviri
English: Colchicine plasma concentrations may be increased when co-administered with EVOTAZ.
Icelandic: Plasmaþéttni colchicins getur aukist við samhliða gjöf EVOTAZ.
English: Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with EVOTAZ may result in increased concentrations.
Icelandic: Umbrot simvastatins og lovastatins eru afar háð CYP3A4 og samhliða gjöf EVOTAZ getur aukið þéttnina.
English: Co-administration of EVOTAZ and nevirapine is not recommended and may result in a loss of therapeutic effect of EVOTAZ and development of resistance to atazanavir.
Icelandic: Ekki er mælt með samhliða gjöf nevirapins og EVOTAZ sem getur leitt til taps á verkun EVOTAZ og þróun ónæmis gegn atazanavir.