FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no specific antidote for overdose with EVOTAZ.
Icelandic: Ekkert sértækt mótefni er við ofskömmtun með EVOTAZ.
English: Also see PULMONARY ATERIAL HYPERTENSION in this table for further information regarding co-administration of EVOTAZ with sildenafil.
Icelandic: LUNGNAHÁÞRÝSTINGUR í töflunni til frekari upplýsinga þegar EVOTAZ er gefið ásamt sildenafili.
English: In long-term carcinogenicity studies of atazanavir in mice and rats, an increased incidence of benign hepatic adenomas was seen in female mice only.
Icelandic: Í langtímarannsóknum á krabbameinsvaldandi áhrifum atazanavirs á mýs og rottur, er aukin tíðni góðkynja lifraræxla, hjá kvenmúsum eingöngu.
English: Co-administration of EVOTAZ and rilpivirine can be used without dose adjustments, as the expected increase in rilpivirine concentrations is not considered clinically relevant.
Icelandic: Hægt er að nota EVOTAZ samhliða rilpivirini án skammtaaðlögunar þar sem aukning á þéttni rilpivirins sem gert er ráð fyrir skiptir ekki máli klínískt.
English: The mechanism of interaction is P-gp inhibition by atazanavir and cobicistat.
Icelandic: Verkunarháttur milliverkunar er P-gp hömlun af völdum atazanavirs og cobicistat.
English: Co-administration of EVOTAZ with medicinal products that inhibit CYP3A may result in increased plasma concentration of atazanavir and/or cobicistat.
Icelandic: Samhliða gjöf EVOTAZ og lyfja sem hamla CYP3A getur aukið plasmaþéttni atazanavirs og/eða cobicistats.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains atazanavir sulphate corresponding to 300 mg atazanavir and 150 mg of cobicistat.
Icelandic: Hver filmuhúðuð tafla inniheldur atazanavir súlfat sem samsvarar 300 mg atazanavir og 150 mg cobicistat.
English: Tenofovir alafenamide 10 mg once daily/emtricitabine 200 mg once daily (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Icelandic: Tenofovir alafenamid 10 mg einu sinni á dag/emtricitabin 200 mg einu sinni á dag (atazanavir 300 mg einu sinni á dag með cobicistat 150 mg einu sinni á dag)
English: Uncommon (may affect up to 1 in 100 people) torsade de pointes (life threatening irregular heart beat) hypersensitivity (allergic reaction) anorexia (loss of appetite), weight loss, weight gain depression, anxiety, sleep disorder disorientation, amnesia (loss of memory) peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs) syncope (fainting), hypertension (high blood pressure) dyspnoea (shortness of breath) pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores) hepatitis (inflammation of the liver) angioedema (severe swelling of the skin and other tissues most often the lips or the eyes) urticaria (itchy rash), alopecia (unusual hair loss or thinning), pruritus (itching) muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles) nephrolithiasis (formation of kidney stones), interstitial nephritis (kidney inflammation), hematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination), chronic kidney disease (how well your kidneys work) gynaecomastia (breast enlargement in men) chest pain, malaise (generally feeling unwell), fever asthenia (unusual tiredness or weakness) serious skin rashes (allergic reactions including rash, a high temperature, increased levels of liver enzymes seen in blood tests, an increase in a type of white blood cell [esosinophilia] and/or enlarged lymph nodes) (see section 2) gallbladder disorders (gallstones and gallbladder inflammation)
Icelandic: torsade de pointes (lífshættulegar hjartsláttartruflanir) ofnæmi lystarleysi, þyngdartap, þyngdaraukning þunglyndi, kvíði, svefntruflanir vistarfirring, minnisleysi náladofi (dofi, máttleysi, stingir eða verkir í hand- og fótleggjum) yfirlið, hækkaður blóðþrýstingur andnauð (mæði) brisbólga, magabólga, munnbólga með sárum lifrarbólga ofnæmisbjúgur (verulegur þroti í húð og öðrum vefjum yfirleitt í vörum og í augum) ofsakláði, hárlos, kláði vöðvarýrnun, liðverkir, vöðvaverkir nýrnasteinar, nýrnabólga, blóð í þvagi, prótein í þvagi, aukin tíðni þvagláta, langvinnur nýrnasjúkdómur brjóstastækkun hjá körlum brjóstverkur, lasleiki (almenn vanlíðan), hiti þróttleysi (óvenjuleg þreyta eða máttleysi) alvarleg húðútbrot (ofnæmisviðbrögð meðal annars útbrot, hár hiti, hækkun lifrarensíma, sem kemur fram í blóðprófum, aukning á ákveðnum hvítum blóðkornum (esosinophilia) og/eða eitlastækkanir) (sjá kafla 2) gallblöðrukvillar (gallsteinar og gallblöðrubólga)
English: The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or cobicistat and clarithromycin.
Icelandic: Verkunarháttur milliverkunar er CYP3A4 hömlun af völdum atazanavirs og/eða cobicistats og clarithromycins.
English: The co-administration of EVOTAZ with stavudine is not expected to significantly alter the exposure of stavudine.
Icelandic: Þegar EVOTAZ er gefið samhliða stavudini er ekki gert ráð fyrir marktækri breytingu á útsetningu fyrir stavudini.
English: General disorders and administration site conditions common fatigue uncommon pyrexia, asthenia, chest pain, malaise rare gait disturbance a These adverse reactions were identified through post-marketing surveillance; however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to atazanavir (with and without ritonavir) in randomised controlled and other available clinical trials (n = 2321).
Icelandic: a Þessar aukaverkanir komu fram eftir markaðssetningu, hins vegar var tíðnin metin með tölfræðiútreikningum byggðum á heildarfjölda sjúklinga sem fengu atazanavir (með eða án ritonavirs) í slembuðum samanburðarrannsóknum og öðrum tiltækum klínískum rannsóknum (n = 2.321).
English: Co-administration warrants clinical monitoring for sedation and cognitive effects.
Icelandic: Samhliða gjöf krefst klínísks eftirlits vegna slævandi áhrifa og áhrifa á skilvitlega starfsemi.
English: 14-OH clarithromycin 14-OH clarithromycin AUC ↓70%
Icelandic: 14-OH clarithromycin
English: Efavirenz 600 mg once daily (atazanavir 400 mg once daily)
Icelandic: Efavirenz 600 mg einu sinni á dag (atazanavir 400 mg einu sinni á dag)
English: Drospirenone AUC: ↑ 130% Drospirenone Cmax: ↔ Drospirenone Cmin: Not calculated
Icelandic: ↑ 130% Drospirenon Cmax:
English: EVOTAZ is expected to increase simeprevir plasma concentrations.
Icelandic: Gert er ráð fyrir að EVOTAZ auki plasmaþéttni simeprevirs.
English: Do not take EVOTAZ: if you are allergic to atazanavir, cobicistat or any of the other ingredients of this medicine (listed in section 6) if you have moderate to severe liver problems if you are taking any of these medicines: see also Other medicines and EVOTAZ
Icelandic: Z: ef um er að ræða ofnæmi fyrir atazanaviri, cobicistati eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6) ef þú ert með meðalalvarlegan/alvarlegan lifrarsjúkdóm ef þú tekur eitthvert eftirtalinna lyfja: sjá einnig Notkun annarra lyfja samhliða EVOTAZ rifampicin, (sýklalyf notað við berklum) carbamazepin, fenóbarbital og fenýtóín (flogaveikilyf notað til að koma í veg fyrir flog)
English: In the pre- and postnatal development assessment in rats, atazanavir produced a transient reduction in body weight in the offspring at a maternally toxic dose.
Icelandic: Mat á þroska rottuunga fyrir og eftir fæðingu sýndi að atazanavir dró tímabundið úr þyngd afkvæma, í skömmtum sem höfðu eituráhrif á móður.
English: The resistance profile of EVOTAZ is driven by atazanavir.
Icelandic: Ónæmi gegn EVOTAZ tengist atazanavir.
English: The mechanism of interaction is CYP3A4 induction by nevirapine and CYP3A4 inhibition by atazanavir and cobicistat.
Icelandic: Verkunarháttur milliverkunar CYP3A4 virkjun af völdum nevirapins og CYP3A4 hömlun af völdum atazanavirs og cobicistats.
English: Sildenafil, when used for the treatment of pulmonary arterial hypertension, is contraindicated (see section 4.3).
Icelandic: Ekki á að nota sildenafil þegar ábendingin er lungnaháþrýstingur (sjá kafla 4.3).
English: The mechanism of interaction is induction of CYP3A4 by bosentan.
Icelandic: Verkunarháttur milliverkunar er CYP3A4 hömlun af völdum bosentan.
English: High density polyethylene (HDPE) bottle with a child-resistant polypropylene closure.
Icelandic: Háþéttni fjöletýlen (HDPE) glas með öryggisloki úr fjölprópýleni.
English: EVOTAZ is not recommended for co-administration with etravirine because it may result in the loss of therapeutic effect and development of resistance to atazanavir.
Icelandic: Ekki er mælt með samhliða gjöf með etravirini þar sem það getur leitt til taps á verkun og þróun á ónæmi gegn atazanaviri.
English: If signs or symptoms of cholelithiasis occurs, temporary interruption or discontinuation of treatment may be considered.
Icelandic: Ef einkenni gallsteina koma fram þarf að hugleiða tímabundið hlé á meðferðinni eða hætta henni alveg.
English: This will allow quick identification of new safety information.
Icelandic: til að nýjar upplýsingar um öryggi lyfsins komist fljótt og örugglega til skila.
English: There are limited clinical data with cobicistat in pregnant women.
Icelandic: Takmarkaðar upplýsingar liggja fyrir um notkun cobicistats á meðgöngu.
English: In a trial where HIV-infected subjects (n=22) were instructed to take atazanavir 300 mg with cobicistat 150 mg once daily with food, the steady-state atazanavir Cmax, AUCtau and Ctau (mean ± SD) values were 3.9 ± 1.9 μg/ml, 46.1 ± 26.2 μg•hr/ml and 0.80 ± 0.72 μg/ml, respectively.
Icelandic: Cmax fyrir atazanavir við jafnvægi 3,9 ± 1,9 μg/ml, AUCtau var 46,1 ± 26,2 μg•klst./ml og Ctau 0,80 ± 0,72 μg/ml.
English: The mechanism of interaction is CYP3A and/or P-glycoprotein inhibition by atazanavir and cobicistat.
Icelandic: Verkunarháttur milliverkunar er CYP3A og/eða P-gp hömlun af völdum atazanavirs og cobicistats.
English: The mechanism of interaction is inhibition of P-gp by cobicistat.
Icelandic: Verkunarháttur milliverkunar er hömlun P-gp af völdum cobicistats.
English: Lamivudine 150 mg twice daily + zidovudine 300 mg twice daily (atazanavir 400 mg once daily)
Icelandic: Lamivudin 150 mg tvisvar á dag + zidovudin 300 mg tvisvar á dag (atazanavir 400 mg einu sinni á dag)
English: Glecaprevir 300 mg/pibrentasvir 120 mg once daily (atazanavir 300 mg with ritonavir 100 mg once daily*)
Icelandic: Glecaprevir 300 mg/pibrentasvir 120 mg einu sinni á dag (atazanavir 300 mg og ritonavir 100 mg einu sinni á dag)
English: Clarithromycin AUC ↑94% (↑75%
Icelandic: AUC ↑94% (↑75%
English: In clinical study GS-US-216-0114, a phase 3 randomised, active-controlled clinical study, in which 692 treatment-naïve patients received at least one dose of atazanavir boosted with cobicistat (n = 344) or atazanavir boosted with ritonavir (n = 348) administered with other antiretroviral medicinal products, the most frequently reported adverse reactions in the atazanavir boosted with cobicistat group during 144 weeks were associated with elevated bilirubin levels (see Table 2).
Icelandic: Algengustu aukaverkanirnar voru tengdar hækkuðu bilirúbíni sem greint var frá hjá hópi sem fékk atazanavir örvað með cobicistati í klínískri 144 vikna rannsókn GS-US-216-0114, sem var 3. stigs slembuð rannsókn með virkum samanburði með 692 sjúklingum sem höfðu ekki fengið meðferð áður og fengu a.m.k. einn skammt af atazanaviri örvað með cobicistati (n = 344) eða atazanaviri örvað með ritonaviri (n = 348) gefið ásamt öðrum andretróveirulyfjum (sjá töflu 2).
English: Medicinal products by therapeutic area
Icelandic: Lyf eftir meðferðarsviði
English: Concomitant use not recommended
Icelandic: Ekki er mælt með samhliða gjöf
English: The mechanism of interaction is CYP3A inhibition.
Icelandic: Verkunarháttur milliverkunar er CYP3A hömlun.
English: Elbasvir 50 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily
Icelandic: Elbasvie 50 mg einu sinni á dag (atazanavir 300 mg / ritonavir 100 mg einu sinni á dag)
English: Atazanavir is a weak to moderate inhibitor of CYP2C8.
Icelandic: Atazanavir er vægur eða meðalöflugur CYP2C8 hemill.
English: ANTIFUNGALS Ketoconazole 200 mg once daily (atazanavir 400 mg once daily)
Icelandic: Ketoconazol 200 mg einu sinni á dag (atazanavir 400 mg einu sinni á dag)
English: Co-administration of tenofovir DF with cobicistat is expected to increase tenofovir plasma concentrations.
Icelandic: Gert er ráð fyrir að samhliða gjöf tenofovir DF og cobicistats auki plasmaþéttni tenofovirs.
English: Co-administration of EVOTAZ with proton pump inhibitors (PPIs) is not recommended due to the decreased solubility of atazanavir as intra-gastric pH increase with PPIs (see section 4.5).
Icelandic: Ekki er mælt með að gefa EVOTAZ samhliða prótonpumpuhemlum vegna minnkaðs leysanleika atazanavirs þar sem pH í maga eykst af völdum prótonpumpuhemla (sjá kafla 4.5).
English: Boceprevir 800 mg three times daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Icelandic: Boceprevir 800 mg þrisvar á dag (atazanavir 300 mg/ritonavir 100 mg einu sinni á dag)
English: Tenofovir alafenamide 10 mg once daily (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Icelandic: Tenofovir alafenamid 10 mg einu sinni á dag (atazanavir 300 mg einu sinni á dag með cobicistat 150 mg einu sinni á dag)
English: The potential for PR prolongation should be considered in cases of overdose (see section 4.9).
Icelandic: á PR bili ef til ofskömmtunar kæmi (sjá kafla 4.9).
English: In these pharmacokinetic trials, the exposure of atazanavir 300 mg with cobicistat 150 mg was consistent with that observed when boosted with ritonavir 100 mg. EVOTAZ is bioequivalent to atazanavir 300 mg once daily in combination with cobicistat 150 mg once daily coadministered as single agents (see section 5.2).
Icelandic: Í þessum lyfjahvarfarannsóknum var útsetning fyrir atazanaviri 300 mg sem var örvuð með cobicistati 150 mg í samræmi við það sem sást þegar það var örvað með ritonaviri 100 mg.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Icelandic: Bakritahemlar sem ekki eru núkleósíð (NNRTI)
English: Rosuvastatin AUC: ↑ 242% Rosuvastatin Cmax: ↑ 958% Rosuvastatin Cmin: Not calculated
Icelandic: ↑ 958% Rosuvastatin Cmin:
English: Buprenorphine, once daily, stable maintenance dose (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Icelandic: Buprenorphin, einu sinni á dag, stöðugur viðhaldsskammtur, (atazanavir 300 mg einu sinni á dag ásamt ritonavir 100 mg einu sinni á dag).
English: Didanosine (enteric coated capsules) 400 mg single dose (atazanavir 400 mg once daily)
Icelandic: Didanosin (sýruhjúphylki) 400 mg stakur skammtur (atazanavir 400 mg einu sinni á dag)
English: EVOTAZ may affect how well your kidneys work.
Icelandic: EVOTAZ getur haft áhrif á starfsemi nýrnanna.
English: No significant effect on didanosine and stavudine concentrations was observed.
Icelandic: Engin marktæk áhrif á þéttni didanosins og stavudins komu í ljós.
English: Fluconazole 200 mg once daily (atazanavir 300 mg and ritonavir 100 mg once daily)
Icelandic: Fluconazol 200 mg einu sinni á dag (atazanavir 300 mg og ritonavir 100 mg einu sinni á dag)
English: EVOTAZ should not be initiated in patients with creatinine clearance less than 70 ml/min if any co-administered agent (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir) requires dose adjustment based on creatinine clearance (see sections 4.4, 4.8 and 5.2).
Icelandic: ef það er gefið samhliða lyfi (t.d. emtricitabin, lamivudin, tenofovir disoproxil eða adefovir) sem krefst skammtaaðlögunar með tilliti til kreatínínúthreinsunar (sjá kafla 4.4, 4.8 og 5.2).
English: Omeprazole 40 mg once daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily, 2 hours after omeprazole)
Icelandic: Omeprazol 40 mg einu sinni á dag (atazanavir 300 mg einu sinni á dag ásamt ritonavir 100 mg einu sinni á dag, 2 klst. á eftir omeprazol)
English: Concentration of fluconazole may be increased if co-administered with cobicistat.
Icelandic: Þéttni fluconazols getur aukist við samhliða gjöf cobicistats.
English: EVOTAZ is not recommended in patients undergoing haemodialysis (see sections 4.2 and 5.2).
Icelandic: Notkun EVOTAZ er ekki ráðlögð hjá sjúklingum sem gangast undir blóðskilun (sjá kafla 4.2 og 5.2).
English: Atazanavir increased opacity of bovine corneas in an in vitro ocular irritation study, indicating it may be an ocular irritant upon direct contact with the eye.
Icelandic: Atazanavir jók ógegnsæi hornhimnu í nautgripum í in vitro í augnertingarprófi, sem bendir til hugsanlegra ertandi áhrifa á augu við beina snertingu.
English: If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), please inform your doctor immediately if you are taking oral contraceptives ("the Pill") to prevent pregnancy.
Icelandic: Ef merki eða einkenni nýrnasteina koma fram (verkur í síðu, blóð í þvagi, verkur við þvaglát) skaltu samstundis láta lækninn vita.
English: As EVOTAZ contains atazanavir and cobicistat, any interactions that have been identified with these active substances individually may occur with EVOTAZ.
Icelandic: Þar sem EVOTAZ inniheldur atazanavir og cobicistat geta milliverkanir sem hafa komið fram með þessum virku efnum einum og sér einnig komið fram með EVOTAZ.
English: Clinical monitoring may be needed upon co-administration with EVOTAZ.
Icelandic: Klínískt eftirlit getur verið nauðsynlegt við samhliða gjöf EVOTAZ.
English: Stevens-Johnson syndrome (allergic reactions including serious skin rash, a high temperature and enlarged lymph nodes) (see section 2).
Icelandic: Stevens-Johnson heilkenni (ofnæmisviðbrögð m.a. alvarleg húðútbrot, hár hiti og eitlastækkun) (sjá kafla 2) vöðvakvilli (einkenni frá vöðvum sem tengjast ekki áreynslu) verkur í nýrum
English: Plasma concentrations of atorvastatin are increased when coadministered with atazanavir/cobicistat
Icelandic: Plasmaþéttni atorvastatins eykst við gjöf samhliða atazanavir/cobicistat
English: The mechanism of interaction is CYP3A induction by the antiepileptic.
Icelandic: Verkunarháttur milliverkunar er virkjun CYP3A af völdum flogaveikilyfjanna.
English: No significant effect on lamivudine and zidovudine concentrations was observed when co-administered with atazanavir.
Icelandic: Engin marktæk áhrif á þéttni lamivudins og zidovudins komu í ljós við samhliða gjöf atazanavirs.
English: available for co-administration of EVOTAZ with either ketoconazole or itraconazole.
Icelandic: Sérstakar ráðleggingar um skammta eru ekki fyrirliggjandi við samhliða gjöf EVOTAZ með annaðhvort ketoconazol eða itraconazol.
English: Immune system disorders uncommon hypersensitivity
Icelandic: Ónæmiskerfi sjaldgæfar ofnæmi
English: No clinically relevant differences in cobicistat pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Icelandic: Enginn klínískt marktækur munur kom fram á lyfjahvörfum cobicistats hjá einstaklingum með meðalskerta lifrarstarfsemi og heilbrigðum einstaklingum.
English: Concentrations of atazanavir given with cobicistat are expected to be increased in patients with impaired hepatic function (see sections 4.2 and 4.4).
Icelandic: Gert er ráð fyrir að þéttni atazanavirs með eða án cobicistat aukist hjá sjúklingum með skerta lifrarstarfsemi (sjá kafla 4.2 og 4.4).
English: Cobicistat is a strong mechanism-based CYP3A inhibitor and a weak CYP2D6 inhibitor.
Icelandic: Cobicistat er öflugur CYP3A hemill háður verkunarhætti og vægur CYP2D6 hemill.
English: Atazanavir, an active component of EVOTAZ, has been detected in human milk.
Icelandic: Atazanavir, virka efnið í EVOTAZ, hefur verið greint í brjóstamjólk.
English: Rifampicin 600 mg once daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Icelandic: Rifampicin 600 mg einu sinni á dag (atazanavir 300 mg einu sinni á dag með ritonavir 100 mg einu sinni á dag)
English: ANTIHISTAMINE AGENTS Astemizole
Icelandic: ANDHISTAMÍN Astemizol Terfenadin
English: Atazanavir is metabolised principally by CYP3A4.
Icelandic: Atazanavir umbrotnar aðallega fyrir tilstilli CYP3A4.
English: Drug interaction trials were not conducted for EVOTAZ.
Icelandic: Rannsóknir á milliverkunum hafa ekki verið gerðar með EVOTAZ.
English: For more information consult the cobicistat Summary of Product Characteristics.
Icelandic: Sjá samantekt á eiginleikum cobicistats fyrir frekari upplýsingar.
English: The mechanism of interaction is inhibition of UGT1A1 by atazanavir.
Icelandic: Verkunarháttur milliverkunar er UGT1A1 hömlun af völdum atazanavirs.
English: Omeprazole 20 mg once daily am (atazanavir 300 mg once daily with ritonavir 100 mg once daily pm, 12 hours after omeprazole)
Icelandic: Omeprazol 20 mg einu sinni á dag, fyrir hádegi (atazanavir 300 mg einu sinni á dag ásamt ritonavir 100 mg einu sinni á dag eftir hádegi,12 klst. eftir omeprazol)
English: Blanchardstown Corporate Park 2
Icelandic: Blanchardstown
English: Atorvastatin AUC: ↑ 822% Atorvastatin Cmax: ↑ 1785% Atorvastatin Cmin: Not calculated
Icelandic: ↑ 1785% Atorvastatin Cmin:
English: The mechanism of this decrease is unknown (see sections 4.2 and 4.4.)
Icelandic: (Sjá kafla 4.2 og 4.4).
English: Hepatic impairment Atazanavir
Icelandic: Próteasahemlar við lifrarbólgu
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets.
Icelandic: 30 filmuhúðaðar töflur.
English: Co-administration of EVOTAZ and hormonal contraceptives should be avoided.
Icelandic: Forðast á samhliða gjöf EVOTAZ og hormónagetnaðarvarna.
English: Nevirapine 200 mg twice daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Icelandic: Nevirapin 200 mg tvisvar á dag (atazanavir 300 mg einu sinni á dag með ritonavir 100 mg einu sinni á dag)
English: EVOTAZ is not recommended for patients undergoing haemodialysis (see sections 4.4 and 5.2).
Icelandic: Ekki er mælt með EVOTAZ hjá sjúklingum sem gangast undir blóðskilun (sjá kafla 4.4 og 5.2).
English: substrates of CYP3A4 or the UGT1A1 isoform of UDP-glucuronyltransferase and have narrow therapeutic windows: alfuzosin (alpha-1-adrenoreceptor antagonist) amiodarone, bepridil, dronedarone, quinidine, systemic lidocaine (antiarrhythmics/antianginals) astemizole, terfenadine (antihistamines) cisapride (gastrointestinal motility agent) ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) pimozide, quetiapine, lurasidone (antipsychotics/neuroleptics) (see section 4.5) ticagrelor (platelet aggregation inhibitor) triazolam, midazolam administered orally (sedatives/hypnotics) (for caution on parenterally administered midazolam, see section 4.5).
Icelandic: amiodaron, bepridil, dronedaron, quinidin, lidocain til altækrar notkunar (lyf við hjartsláttartruflunum/hjartaöng) astemizol, terfenadin (andhistamín) cisaprið (lyf sem hefur áhrif á þarmahreyfingar) ergotafleiður (t.d. dihydroergotamin, ergometrin, ergotamin, methylergonovin) pimozið, quetiapin, lurasidone (geðrofslyf/geðlyf) (sjá kafla 4.5) ticagrelor (hamlar blóðflagnasamloðun) triazolam, midazolam til inntöku (róandi lyf/svefnlyf) (um varnaðarorð fyrir midazolam stungulyf, sjá kafla 4.5).
English: Atazanavir Cmax ↓9% (↓16% ↓1%) Atazanavir Cmin ↓19% (↓31%
Icelandic: Atazanavir AUC ↓10% (↓18% ↓2%) Atazanavir Cmax ↓9% (↓16% ↓1%) Atazanavir Cmin ↓19% (↓31% ↓6%)
English: Alternative antiretroviral therapy to EVOTAZ may be considered if jaundice or scleral icterus is unacceptable to a patient.
Icelandic: Hugleiða þarf aðra meðferð en EVOTAZ meðferð ef gula eða gul augnhvíta reynist óbærileg fyrir sjúklinginn.
English: Rifabutin 150 mg twice weekly (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Icelandic: Rifabutin 150 mg tvisvar í viku (atazanavir 300 mg og ritonavir 100 mg einu sinni á dag)
English: Not applicable.
Icelandic: Ekki reiknað
English: What you need to know before you take EVOTAZ
Icelandic: Áður en byrjað er að nota EVOTAZ
English: Increase monitoring for adverse reactions.
Icelandic: Lýsing á völdum aukaverkunum fyrir nánari upplýsingar.
English: The following statements reflect the pharmacokinetic properties of atazanavir in combination with cobicistat or the individual components of EVOTAZ.
Icelandic: Eftirfarandi endurspeglar lyfjahvarfaeiginleika atazanavirs í samsetningu með cobicistat, eða stakra þátta EVOTAZ.