FrancophonIA/ELRC3.0 huggingface dataset:
English: During attempts to overcome the decreased exposure by increasing the dose of REYATAZ or other protease inhibitors with ritonavir, a high frequency of liver reactions was seen.
Icelandic: Þegar skammtar REYATAZ eða annarra próteasahemla með rítónavíri voru auknir í tilraunum til að vinna bug á minnkaðri útsetningu varð vart við hækkaða tíðni aukaverkana á lifur
English: , toxic skin eruptions a,b
Icelandic: , ofnæmisbjúgur a, ofsakláði, hárlos,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 200 mg of atazanavir (as sulphate).
Icelandic: VIRK(T) EFNI Hvert hylki inniheldur 200 mg atazanavír (sem súlfat).
English: Each capsule contains 150 mg of atazanavir (as sulphate).
Icelandic: Hvert hylki inniheldur 150 mg atazanavír (sem súlfat).
English: Also see PULMONARY ATERIAL HYPERTENSION in this table for further information regarding co-administration of REYATAZ/ritonavir with sildenafil.
Icelandic: LUNGNAHÁÞRÝSTINGUR í töflunni til frekari upplýsinga þegar REYATAZ/rítónavír er gefið ásamt síldenafíl.
English: Buprenorphine, once daily, stable maintenance dose (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Icelandic: Búprenorfín, einu sinni á dag, stöðugur viðhaldsskammtur, (atazanavír 300 mg einu sinni á dag ásamt rítónavíri 100 mg einu sinni á dag)
English: REYATAZ 300 mg hard capsules are supplied in bottles of 30 capsules.
Icelandic: REYATAZ 300 mg hörð hylki eru í glösum með 30 hylkjum.
English: Co-administration of nevirapine and REYATAZ is not recommended (see section 4.4)
Icelandic: Ekki er mælt með samhliða gjöf nevírapíns og REYATAZ (sjá kafla 4.4)
English: Patients should not breast-feed while taking REYATAZ.
Icelandic: Sjúklingar sem taka REYATAZ eiga ekki að vera með barn á brjósti.
English: Patients co-infected with hepatitis B and/or hepatitis C virus 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: 300 mg atazanavír einu sinni á dag með 100 mg rítónavír einu sinni á dag voru 97 sjúklingar einnig með langvinna lifrarbólgu B eða C. Meiri líkur eru á transamínasahækkun hjá sjúklingum sem einnig eru með lifrarbólgu
English: Co-administration of REYATAZ with proton pump inhibitors is not recommended (see section 4.5).
Icelandic: Ekki er ráðlagt að gefa REYATAZ samtímis prótónpumpuhemlum (sjá kafla 4.5).
English: REYATAZ must not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4, and 5.2).
Icelandic: REYATAZ má ekki nota hjá sjúklingum með alvarlega lifrarbilun (sjá kafla 4.2, 4.4 og 5.2).
English: Carbamazepine
Icelandic: Blanchardstown
English: Uncommon (may affect up to 1 in 100 people): peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs) hypersensitivity (allergic reaction) asthenia (unusual tiredness or weakness) weight decreased, weight gain, anorexia (loss of appetite), appetite increased depression, anxiety, sleep disorder disorientation, amnesia (loss of memory), dizziness, somnolence (sleepiness), abnormal dream 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), dysgeusia (impairment of the sense of taste), flatulence (wind), dry mouth, abdominal distension angioedema (severe swelling of the skin and other tissues most often the lips or the eyes) alopecia (unusual hair loss or thinning), pruritus (itching)
Icelandic: Sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 100 notendum): einkenni frá úttaugum (dofi, máttleysi, náladofi eða verkur í hand- og fótleggjum) ofnæmisviðbrögð þróttleysi (óvenjuleg þreyta eða máttleysi) þyngdarminnkun, þyngdaraukning, lystarleysi, aukin matarlyst þunglyndi, kvíði, svefnerfiðleikar vistarfirring, minnisleysi, sundl, svefnhöfgi, óvenjulegir draumar yfirlið, háþrýstingur mæði (andnauð) brisbólga, magabólga, munnangur (munnbólga með sárum og áblásturssótt), breyting á bragðskyni, vindgangur, munnþurrkur, þaninn kviður ofnæmisbjúgur (veruleg bólga í húð og öðrum vefjum yfirleitt á vörum eða augum) hárlos, kláði vöðvarýrnun, liðverkir, vöðvaverkir millivefsbólga nýrna (nýrnabólga), blóðmiga (blóð í þvagi), próteinmiga (umframmagn próteina í þvagi), óeðlilega tíð þvaglát brjóstastækkun hjá körlum brjóstverkur, lympa (almenn vanlíðan), hiti svefnerfiðleikar
English: Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (see section 4.5).
Icelandic: Samhliðagjöf með lyfjum sem eru hvarfefni P450 ísóensímsins CYP3A4 og eru með þröngt lækningalegt bil (t.d. quetiapín, alfuzosín, astemizól, terfenadín, cisapríð, pímózíð, kínidín, lurasidon, bepridíl, tríazólam, mídazólam til inntöku (gæta skal varúðar þegar mídazólam er gefið sem stungulyf/innrennslislyf, sjá kafla 4.5) og korndrjólaalkalóíða, einkum ergotamín, díhýdróergotamín, ergonóvín, metýlergonóvín) (sjá kafla 4.5).
English: REYATAZ 200 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Icelandic: REYATAZ 200 mg hörð hylki eru einnig í þynnupakkningum með 60 hylkjum.
English: Liver problems may uncommonly happen.
Icelandic: Lifrarsjúkdómur getur komið fram en það er sjaldgæft.
English: SPECIAL STORAGE CONDITIONS Bottle pack:
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Glas:
English: uncommon: nephrolithiasis a, haematuria, proteinuria, pollakiuria, interstitial nephritis, chronic kidney diseasea; rare: kidney pain
Icelandic: algengar: gula sjaldgæfar: lifrarbólga, gallsteinar a, gallteppa a mjög sjaldgæfar: lifrar- og miltisstækkun, gallblöðrubólgaa
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Icelandic: Bakritahemlar sem ekki eru núkleósíð (NNRTI) Efavírenz 600 mg einu sinni á dag (atazanavír 400 mg einu sinni á dag ásamt rítónavíri 100 mg einu sinni á dag)
English: Paediatric patients (at least 3 months of age and weighing at least 5 kg): REYATAZ oral powder is available for paediatric patients at least 3 months of age and weighing at least 5 kg (see Summary of Product Characteristics for REYATAZ oral powder).
Icelandic: REYATAZ duft til inntöku, er fáanlegt fyrir börn sem eru að minnsta kosti 3 mánaða gömul og sem vega að minnsta kosti 5 kg (sjá Samantekt á eiginleikum lyfs fyrir REYATAZ duft til inntöku).
English: Children receiving REYATAZ may require their heart to be monitored.
Icelandic: Nauðsynlegt getur verið að fylgjast með hjartastarfsemi hjá börnum sem fá REYATAZ. Læknirinn ákveður það.
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 atazanavírs í skömmtum sem ollu einstaka lifrarfrumudrepi hjá kvenmúsum var 12 sinnum meiri en hjá mönnum við ráðlagðan skammt.
English: REYATAZ 150 mg hard capsules atazanavir
Icelandic: REYATAZ 150 mg hörð hylki atazanavír
English: REYATAZ is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition.
Icelandic: REYATAZ getur aukið plasmaþéttni lurasidons vegna CYP3A4 hömlunar.
English: Simvastatin Lovastatin
Icelandic: Lýsing á völdum aukaverkunum
English: At least 5 to less than 15
Icelandic: Að minnsta kosti 5 til minna en
English: Co-administration of salmeterol with REYATAZ/ritonavir is not recommended (see section 4.4).
Icelandic: Samhliða gjöf salmeteróls og REYATAZ/rítónavírs er ekki ráðlögð (sjá kafla 4.4).
English: Treatment-Naive REYATAZ Capsules/ritonavir (300 mg/100 mg once daily) n=16
Icelandic: Sjúklingar sem hafa ekki fengið meðferð með andretróveirulyfjum REYATAZ Hylki/rítónavír (300 mg/100 mg einu sinni á sólarhring) n=16
English: Studies conducted in HIVinfected patients.
Icelandic: Rannsóknir gerðar á sjúklingum með HIV smit.
English: In previous studies, the pharmacokinetics of atazanavir was not altered by rifabutin.
Icelandic: Í fyrri rannsóknum kom fram að rifabútín hafði ekki áhrif á lyfjahvörf atazanavírs.
English: Atazanavir AUC ↓19% (↓35% ↑2%) * Atazanavir Cmax ↔2% (↓15% ↑24%) * Atazanavir Cmin ↓59% (↓73% ↓40%) *
Icelandic: Atazanavír AUC ↓19% (↓35% ↑2%) * Atazanavír Cmax ↔2% (↓15% ↑24%)
English: The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between REYATAZ and comparator regimens (see section 4.4).
Icelandic: B eða C var sambærileg milli REYATAZ og samanburðar meðferðarinnar (sjá kafla 4.4).
English: a Intent-to-treat analysis, with missing values considered as failures.
Icelandic: a Meðferðarákvörðunargreining (intent-to-treat analysis), þar sem litið var á gildi sem vantaði sem meðferðarbrest.
English: Uncommon (may affect up to 1 in 100 people): peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs) hypersensitivity (allergic reaction)
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 notendum): höfuðverkur uppköst, niðurgangur, kviðverkir (magaverkir eða óþægindi), ógleði, meltingartruflanir (tregða) örmögnun
English: REYATAZ 100 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Icelandic: REYATAZ 100 mg hörð hylki eru einnig í þynnupakkningum með 60 hylkjum.
English: Interaction
Icelandic: Útskipting
English: Didanosine should be taken at the fasted state 2 hours after REYATAZ taken with food.
Icelandic: Dídanósín á að taka fastandi 2 klst.
English: other medicines to treat HIV infection (e.g. indinavir, nevirapine and efavirenz) boceprevir and sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C) sildenafil, vardenafil, or tadalafil (used by men to treat impotence (erectile dysfunction)) if you are taking an oral contraceptive ("the Pill") with REYATAZ to prevent pregnancy, be sure to take it exactly as instructed by your doctor and not miss any doses any medicines used to treat diseases related to the acid in the stomach (e.g. antacids to be taken 1 hour before taking REYATAZ or 2 hours after taking REYATAZ, H2-blockers like famotidine and proton pump inhibitors like omeprazole) medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm (amiodarone, diltiazem, systemic lidocaine, verapamil) atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol) salmeterol (used to treat asthma) cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune system) certain antibiotics (rifabutin, clarithromycin) ketoconazole, itraconazole, and voriconazole (antifungals) warfarin (anticoagulant, used to reduce the blood clots) carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptics) irinotecan (used to treat cancer) sedative agents (e.g. midazolam administered by injection) buprenorphine (used to treat opioid addiction and pain).
Icelandic: REYATAZ, H2 blokkar svo sem famótidín og prótónpumpuhemlar svo sem ómeprazól) blóðþrýstingslækkandi lyf, lyf sem hægja á hjartslætti eða við hjartsláttartruflunum (amíódarón, diltiazem, lídokain til altækrar notkunar, verapamíl) atorvastatín, pravastatín og flúvastatín (notað til að draga úr kólesteróli í blóði) salmeteról (notað við astma) cýclósporín, tacrolímus og sirólímus (ónæmisbælandi lyf) ákveðin sýklalyf (rífabútín, clarithrómýcin) ketókónazól, ítrakónazól og vorikónazól (sveppalyf) warfarin (blóðþynningarlyf, notað til að koma í veg fyrir blóðkekki) karbamazepín, fenýtóín, fenóbarbital, lamotrigín (flogaveikilyf) irinótecan (krabbameinslyf) róandi lyf (t.d. mídazólam sem stungulyf) búprenorfín (notað við ópíumfíkn og verkjum).
English: 1157 cells/ mm
Icelandic: (á bilinu:100-1.157 frumur/mm
English: Tenofovir disoproxil fumarate 300 mg once daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Icelandic: Tenófóvír dísóproxílfúmarat 300 mg einu sinni á dag (atazanavír 300 mg einu sinni á dag ásamt rítónavíri 100 mg einu sinni á dag)
English: Difference estimate e
Icelandic: Greining samkvæmt meðferðaráætlun e
English: The combination of rifampicin and REYATAZ with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Icelandic: Ekki má nota rifampicin samhliða REYATAZ ásamt lágskammta rítónavíri (sjá kafla 4.3).
English: Norethindrone AUC ↑110% (↑68% Norethindrone Cmax ↑67% (↑42% Norethindrone Cmin ↑262% (↑157%
Icelandic: Noretindrón AUC ↑ 110% (↑68%; Noretindrón Cmax ↑67% (↑42%;
English: Co-administration with REYATAZ may result in increased concentrations of salmeterol and an increase in salmeterol-associated adverse events.
Icelandic: Samhliða gjöf REYATAZ getur aukið þéttni salmeteróls og aukið aukaverkanir sem tengjast salmeteróli.
English: Your doctor will evaluate how severe your liver disease is before deciding whether you can take REYATAZ if you are taking any of these medicines: see also Other medicines and REYATAZ rifampicin (an antibiotic used to treat tuberculosis) astemizole or terfenadine (commonly used to treat allergy symptoms, these medicines may be available without prescription); cisapride (used to treat gastric reflux, sometimes called heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); and alfuzosin (used to treat enlarged prostatic gland) quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder); lurasidone (used to treat schizophrenia) medicines containing St. John's wort (Hypericum perforatum, a herbal preparation)
Icelandic: Notkun annarra lyfja samhliða REYATAZ rifampicin (sýklalyf notað við berklum) astemízól eða terfenadín (algeng lyf við ofnæmi, hugsanlega fáanleg án lyfseðils), cisaprid (notað við bakflæði, stundum kallað brjóstsviði), prímózíd (notað við geðklofa), kinidín eða bepridíl (notað við hjartsláttartruflunum), ergotamín, dehýdróergotamín, ergonóvín, metýlergonóvín (notað við höfuðverk) og alfuzosín (notað við blöðruhálskirtilsstækkun) quetiapín (notað við geðklofa, geðhvörfum og alvarlegu þunglyndi): lurasidon (notað við geðklofa) lyf sem innihalda jóhannesarjurt (Hypericum perforatum, náttúrulyf) tríazólam, og mídazólam til inntöku (notað til að auðvelda fólki að sofna og/eða draga úr kvíða)
English: Renal impairment: in healthy subjects, the renal elimination of unchanged atazanavir was approximately 7% of the administered dose.
Icelandic: Skert nýrnastarfsemi: hjá heilbrigðum einstaklingum er útskilnaður af gefnum skammti á óbreyttu formi um nýru u.þ.b. 7%.
English: Boceprevir 800 mg three times daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Icelandic: Boceprevír 800 mg þrisvar á dag (atazanavír 300 mg/rítónavír 100 mg einu sinni á dag)
English: Table 8: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg Pharmacokinetic Parameter 2nd Trimester (n=9)
Icelandic: Lyfjahvörf atazanavírs ásamt rítónavíri við stöðuga blóðþéttni hjá ófrískum konum með HIV sýkingu ekki fastandi atazanavír 300 mg ásamt rítónavíri 100 mg
English: Efavirenz 600 mg once daily (atazanavir 400 mg once daily with ritonavir 200 mg once daily)
Icelandic: Efavírenz 600 mg einu sinni á dag (atazanavír 400 mg einu sinni á dag ásamt rítónavíri 200 mg einu sinni á dag)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 150 mg of atazanavir (as sulphate).
Icelandic: VIRK(T) EFNI Hvert hylki inniheldur 150 mg atazanavír (sem súlfat).
English: Paediatric trials with REYATAZ capsules
Icelandic: Mat á aukaverkunum af meðferð með REYATA
English: Antiretroviral treatment experienced adult patients In antiretroviral treatment experienced patients from Studies 009, 043, and 045, 100 isolates from patients designated as virological failures on therapy that included either atazanavir, atazanavir + ritonavir, or atazanavir + saquinavir were determined to have developed resistance to atazanavir.
Icelandic: Í 100 stofnum frá sjúklingum þar sem meðferð með veirueyðandi lyfjum hafði ekki skilað viðunandi árangri með annaðhvort atazanavíri, atazanavíri+rítónavír, eða atazanavíri+saquinavíri var ónæmi fyrir atazanavíri staðfest.
English: Also see PULMONARY ARTERIAL HYPERTENSION in this table for further information regarding coadministration of REYATAZ with sildenafil.
Icelandic: LUNGNAHÁÞRÝSTINGUR í töflunni til frekari upplýsinga þegar REYATAZ er gefið ásamt síldenafíl.
English: REYATAZ 300 mg hard capsules atazanavir
Icelandic: REYATAZ 300 mg hörð hylki atazanavír
English: Sildenafil, when used for the treatment of pulmonary arterial hypertension, is contraindicated (see section 4.3).
Icelandic: Ekki á að nota síldenafíl þegar ábendingin er lungnaháþrýstingur (sjá kafla 4.3).
English: Atazanavir (pm): all administered with food
Icelandic: Dídanósín (með mat)
English: Sofosbuvir AUC : ↑40% (↑25% ↑57%) Sofosbuvir Cmax :↑29% (↑9% ↑52%) Velpatasvir AUC: ↑93% (↑58% Velpatasvir Cmax : ↑29% (↑7% ↑56%) Voxilaprevir AUC : ↑331% (↑276% Voxilaprevir Cmax : ↑342% (↑265%
Icelandic: ↑40% (↑25% ↑57%) Sófosbúvír Cmax :↑29% (↑9% ↑52%) Velpatasvír AUC: ↑93% (↑58% Velpatasvír Cmax :
English: The co-administration of REYATAZ/ritonavir with stavudine is not expected to significantly alter the exposure of stavudine.
Icelandic: REYATAZ/rítónavíri er ekki gert ráð fyrir marktækri breytingu á útsetningu fyrir stavúdíni.
English: Co-administration of salmeterol and REYATAZ is not recommended (see section 4.5).
Icelandic: Samhliða gjöf salmeteróls og REYATAZ er ekki ráðlögð (sjá kafla 4.5).
English: REYATAZ may affect how well your kidneys work.
Icelandic: REYATAZ getur haft áhrif á starfsemi nýrnanna.
English: Week 48: -3% [-7.6%, 1.5%] Week 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 copies/ml, % by Baseline Characteristicd HIV RNA <100,000 copies/ml
Icelandic: -3% [-7,6%, 1,5%] Vika 96: 2,2% [-2,3%, 6,7%]
English: TreatmentExperienced REYATAZ Capsules/ritonavir (300 mg/100 mg once daily) n=25
Icelandic: Sjúklingar sem hafa fengið meðferð með andretróveirulyfjum REYATAZ Hylki/rítónavír (300 mg/100 mg einu sinni á sólarhring) n=25
English: b REYATAZ/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Icelandic: b REYATAZ/rítónavír með tenófóvír dísóproxílfumarati/emtricitabíni (fastur skammtur 300 mg/200 mg töflur einu sinni á dag).
English: The mixture is fed to the infant or young child. An additional tablespoon of food is added to the small container for thorough delivery of the powder from the container and contents are mixed.The entire residual mixture is fed to the child. 3.
Icelandic: Síðan er einni matskeið af fæðu bætt við í ílátið svo hægt sé að ná öllu duftinu úr ílátinu og innihaldinu blandað saman.
English: 300 mg (6 sachetsb)
Icelandic: 300 mg (6 skammtapokar a)
English: The mechanism of interaction is CYP3A4 inhibition by REYATAZ and/or ritonavir.
Icelandic: Verkunarháttur milliverkunar er CYP3A4 hömlun vegna REYATAZ og/eða rítónavírs.
English: d Includes patients with baseline resistance data.
Icelandic: d M.a. sjúklingar með ónæmi í upphafi meðferðar.
English: Proton pump inhibitors Omeprazole 40 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Icelandic: Prótónpumpuhemlar Ómeprazól 40 mg einu sinni á dag (atazanavír 400 mg einu sinni á dag ásamt rítónavíri 100 mg einu sinni á dag)
English: Atazanavir Cmin ↔1% (↓16% ↑18%)
Icelandic: Atazanavír Cmax ↔2% (↓13% ↑8%)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 300 mg of atazanavir (as sulphate).
Icelandic: VIRK(T) EFNI Hvert hylki inniheldur 300 mg atazanavír (sem súlfat).
English: Distribution: atazanavir was approximately 86% bound to human serum proteins over a concentration range of 100 to 10,000 ng/ml.
Icelandic: Dreifing: þegar þéttni atazanavírs er á bilinu 100 til 10.000 ng/ml er það u.þ.b. 86% próteinbundið í sermi hjá mönnum.
English: REYATAZ 150 mg hard capsules are supplied in bottles of 60 capsules.
Icelandic: REYATAZ 150 mg hörð hylki eru í glösum með 60 hylkjum.
English: REYATAZ with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.4 and 5.2).
Icelandic: Ekki er mælt með REYATAZ ásamt rítónavíri hjá sjúklingum sem gangast undir blóðskilun (sjá kafla 4.4 og 5.2).
English: Each capsule contains 300 mg of atazanavir (as sulphate).
Icelandic: Hvert hylki inniheldur 300 mg atazanavír (sem súlfat).
English: REYATAZ 200 mg hard capsules are supplied in bottles of 60 capsules.
Icelandic: REYATAZ 200 mg hörð hylki eru í glösum með 60 hylkjum.
English: Blister pack: 60 hard capsules
Icelandic: 60 hörð hylki
English: Therefore, REYATAZ with ritonavir is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Icelandic: Því á ekki að gefa REYATAZ ásamt rítónavíri samtímis lyfjum sem eru hvarfefni CYP3A4 og eru með þröngt lækningalegt bil t.d. quetiapín, lursidon, alfuzosín, astemizól, terfenadín, cisapríð, pímózíð, kínidín, bepridíl, tríazólam, mídazólam til inntöku og korndrjólaalkalóíðum, einkum ergotamín og díhýdróergotamín (sjá kafla 4.3).
English: If the combination of
Icelandic: Þegar stavúdín er gefið samhliða
English: Indinavir is associated with indirect unconjugated hyperbilirubinaemia due to inhibition of UGT.
Icelandic: Indínavír tengist óbeint bilirúbínaukningu í blóði (óbundið bilirúbín) vegna bælingar á UGT.
English: Antiretroviral treatment naive adult patients
Icelandic: Fullorðnir sjúklingar sem hafa fengið meðferð með andretróveirulyfjum
English: The mean baseline CD4 cell count was 214 cells/mm3 (range: 2 to 810 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.94 log10 copies/ml (range: 2.6 to 5.88 log10 copies/ml).
Icelandic: a Meðalupphafsgildi CD4 var 214 frumur/mm3 (á bilinu 2 til 810 frumur/mm3 og meðalupphafsgildi HIV-1 RNA í plasma var 4,94 log10 eintök/ml (á bilinu 2,6 til 5,88 log10 eintök/ml) b REYATAZ/rítónavír með tenófóvír dísóproxílfumarati/emtricitabíni (fastur skammtur 300 mg/200 mg töflur einu sinni á dag).
English: REYATAZ 100 mg hard capsules atazanavir
Icelandic: REYATAZ 100 mg hörð hylki atazanavír
English: Co-administration of REYATAZ and elbasvir/grazoprevir is contraindicated because of a significant increase in grazoprevir plasma concentrations and an associated potential increase in the risk of ALT elevations (see section 4.3).
Icelandic: Ekki má gefa REYATAZ samhliða elbasvir/grazoprevir vegna marktækrar aukningar á þéttni grazoprevirs í plasma ásamt hugsanlega aukinni hættu á ALT hækkun (sjá kafla 4.3).
English: Table 1: Dose for paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) for REYATAZ capsules with ritonavir Body Weight (kg)
Icelandic: Börn (6 ára til yngri en 18 ára og sem vega að minnsta kosti 15 kg)
English: Co-administration of salmeterol with REYATAZ is not recommended (see section 4.4).
Icelandic: Samhliða gjöf salmeteróls og REYATAZ er ekki ráðlögð (sjá kafla 4.4).
English: Capsule shells: gelatine, red iron oxide, black iron oxide, yellow iron oxide, indigocarmin (E132) and titanium dioxide (E171)
Icelandic: Hylkin innihalda: króspóvídón, mjólkursykureinhýdrat og magnesíumsterat Hylkin sjálf: matarlím, rautt járnoxíð, svart járnoxíð, gult járnoxíð, indígókarmín (E132) og títantvíoxíð (E171)