FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose related asymptomatic prolongations in PR interval with atazanavir, a component of EVOTAZ have been observed in clinical studies.
Icelandic: Í klínískum rannsóknum á atazanaviri, sem er hluti af EVOTAZ; hefur verið greint frá einkennalausri skammtaháðri lengingu á PR bili.
English: Co-administration of atorvastatin with EVOTAZ is not recommended.
Icelandic: Samhliða gjöf atorvastatins og EVOTAZ er ekki ráðlögð.
English: Triazolam
Icelandic: Verapamil
English: EVOTAZ should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
Icelandic: EVOTAZ á að gefa 2 klst. fyrir eða 1 klst.
English: Cardiac disorders uncommon torsades de pointesa rare
Icelandic: Æxlunarfæri og brjóst sjaldgæfar brjóstastækkun hjá körlum
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Icelandic: B eða C sjá samantekt á eiginleikum þessara lyfja.
English: Plasma concentrations of rosuvastatin are increased when coadministered with atazanavir/cobicistat.
Icelandic: Plasmaþéttni rosuvastatins eykst við gjöf samhliða atazanavir/cobicistat.
English: No data are available on the pharmacokinetics of atazanavir and cobicistat in combination in paediatric patients.
Icelandic: Engar upplýsingar liggja fyrir um lyfjahvörf samsetningarinnar atazanavir og cobicistat hjá börnum.
English: Diltiazem Cmax ↑98% (↑78%
Icelandic: Diltiazem Cmax ↑98% (↑78% ↑119%) Diltiazem Cmin ↑142% (↑114%
English: Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indeces and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Icelandic: Ekki á að nota lyf ásamt EVOTAZ sem eru hvarfefni CYP3A og eru með þröngt læknanlegt bil og aukin plasmaþéttni þeirra tengist alvarlegum og lífshættulegum tilvikum.
English: The combination of avanafil and EVOTAZ is contraindicated (see section 4.3).
Icelandic: Ekki á að nota avanafil og EVOTAZ samhliða (sjá kafla 4.3).
English: Coadministration of EVOTAZ with voxilaprevir-containing regimens is not recommended.
Icelandic: Gjöf EVOTAZ samhliða meðferð sem inniheldur voxilaprevir er ekki ráðlögð.
English: ANTIDIABETICS Metformin
Icelandic: SYKURSÝKILYF Metformin
English: Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Icelandic: Sýnt hefur verið fram á að cobicistat dregur úr áætlaðri kreatínínúthreinsun vegna hömlunar pípluseytingar kreatíníns.
English: Higher concentrations could potentiate tenofovir-associated adverse reactions, including renal disorders.
Icelandic: Aukin þéttni getur aukið aukaverkanir sem tengjast tenofoviri þ.m.t. truflun á nýrnastarfsemi.
English: Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Icelandic: Hafa skal aukið eftirlit með aukaverkunum tengdum rifabutini þ.m.t. daufkyrningafæð og æðahjúpsbólgu þar sem búast má við aukinni útsetningu fyrir rifabutini.
English: Atazanavir AUC: ↔ Atazanavir Cmax:↔ Atazanavir Cmin: ↑ 6%
Icelandic: Cmax:↔ Atazanavir Cmin:
English: gait disturbance (abnormal manner of walking) oedema (swelling), palpitation (fast or irregular heart beat) hepatosplenomegaly (enlargement of the liver and spleen) vesiculobullous rash (visible accumulation of fluid under the skin), eczema (skin rash), vasodilatation (widening of blood vessels)
Icelandic: QTc lenging (óreglulegur hjartsláttur) óeðlilegt göngulag bjúgur, hjartsláttarónot (hraður eða óreglulegur hjartsláttur) lifrar- og miltisstækkun vessablöðruútbrot, exem, æðavíkkun
English: If signs or symptoms of nephrolithiasis occurs, temporary interruption or discontinuation of treatment may be considered.
Icelandic: Ef einkenni nýrnasteinakvilla koma fram þarf að hugleiða tímabundið hlé á meðferðinni eða hætta henni alveg.
English: EVOTAZ is not recommended for co-administration with efavirenz.
Icelandic: Ekki er mælt með samhliða gjöf efavirenz og EVOTAZ.
English: SEDATIVES/HYPNOTICS Midazolam
Icelandic: SEFANDI LYF Midazolam Triazolam
English: Atazanavir has been shown in vivo not to induce its own metabolism, nor to increase the biotransformation of some medicinal products metabolised by CYP3A4.
Icelandic: örvar ekki eigin umbrot og eykur ekki umbrot annarra lyfja sem umbrotna fyrir tilstilli CYP3A4.
English: Virologic success
Icelandic: Veirufræðilegur bresturc
English: Concentrations of these sedatives/hypnotics may be increased when co-administered with EVOTAZ.
Icelandic: Þéttni þessara sefandi/róandi lyfja getur aukist við samhliða notkun EVOTAZ.
English: Concentrations of these immunosuppressants may be increased when co-administered with EVOTAZ.
Icelandic: Þéttni þessara ónæmisbælandi lyfja getur aukist þegar þau eru gefin samhliða EVOTAZ.
English: An alternate (non-hormonal) reliable method of contraception is recommended.
Icelandic: Mælt er með notkun annarra öruggra getnaðarvarna (ekki hormóna).
English: The mean (± SD) change in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault method after 144 weeks of treatment was -15.1 ± 16.5 ml/min in the atazanavir boosted with cobicistat plus emtricitabine and tenofovir DF fixed-dose combination group and -8.0 ± 16.8 ml/min in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir DF fixed-dose combination group.
Icelandic: í hópnum sem fékk atazanavir örvað með cobicistati ásamt emtricitabini og tenofovir DF í fastri skammtasamsetningu, og -8,0 ± 16,8 ml/mín.
English: BRISTOL MYERS SQUIBB S.R.L.
Icelandic: BRISTOL MYERS SQUIBB S.R.L. LOC.
English: Cobicistat, a component of EVOTAZ, has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Icelandic: Sýnt hefur verið fram á að cobicistat sem er innihaldsefni EVOTAZ dregur úr áætlaðri kreatínínúthreinsun vegna hömlunar pípluseytingar kreatíníns.
English: Simvastatin Lovastatin
Icelandic: Við ofskömmtun
English: If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom)
Icelandic: Ef þú hefur nýlega notað getnaðarvörn til inntöku eða plástur sem getnaðarvörn skaltu nota viðbótargetnaðarvörn eða aðra gerð getnaðarvarna (t.d. smokk).
English: Cobicistat is primarily metabolised and eliminated by the liver.
Icelandic: Umbrot og brotthvarf cobicistats er að mestu leyti um lifur.
English: Atazanavir Cmax ↑2% (↓4% ↑8%) Atazanavir Cmin ↑15% (↑2%
Icelandic: Atazanavir AUC ↑7% (↓2% ↑17%) Atazanavir Cmax ↑2% (↓4% ↑8%) Atazanavir Cmin ↑15% (↑2% ↑29%)
English: carbamazepine, phenobarbital and phenytoin (antiepileptics used to prevent seizures) 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); amiodarone, dronedarone, quinidine, lidocaine (injectable) or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, ergometrine and 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: astemizol eða terfenadin (algeng lyf við ofnæmi, hugsanlega fáanleg án lyfseðils), cisaprið (notað við bakflæði, stundum kallað brjóstsviði), primozið (notað við geðklofa), amiodaron, dronedaron, kínidín, lidocain (stungulyf) eða bepridil (notað við hjartsláttartruflunum), ergotamin, dehydroergotamin, ergonavin, ergometrin og metylergonavin (notað við höfuðverk) og alfuzosin (notað við blöðruhálskirtilsstækkun) quetiapin (notað við geðklofa, geðhvörfum og alvarlegu þunglyndi); lurasidon (notað við geðklofa) lyf sem innihalda jóhannesarjurt (Hypericum perforatum, náttúrulyf) triazolam og midazolam til inntöku (notað til að auðvelda fólki að sofna og/eða draga úr kvíða) simvastatin og lovastatin (notað til að draga úr kólesteróli í blóði) avanafil (notað við risvandamálum) colchicin (notað við þvagsýrugigt), ef þú ert með nýrna og/eða lifrarsjúkdóm ticagrelor (til að draga úr blóðtappamyndun)
English: Plasma concentrations of trazodone may be increased when co-administered with EVOTAZ.
Icelandic: Plasmaþéttni trazodons getur aukist við samhliða gjöf EVOTAZ.
English: Co-administration of nevirapine and EVOTAZ is expected to increase nevirapine plasma concentrations which may increase the risk of nevirapine-associated toxicity (see section 4.4).
Icelandic: Gert er ráð fyrir að samhliða gjöf nevirapins og EVOTAZ auki þéttni nevirapins í plasma sem getur aukið hættu á eiturverkunum tengdum nevirapini.
English: Plasma concentrations of pitavastatin may be increased if co-administered with EVOTAZ.
Icelandic: Plasmaþéttni pitavastatins getur aukist við samhliða gjöf EVOTAZ.
English: Co-administration of neuroleptics with EVOTAZ may result in increased plasma concentrations of neuroleptics.
Icelandic: Samhliða gjöf sefandi lyfja og EVOTAZ getur aukið plasmaþéttni sefandi lyfjanna.
English: Dolutegravir is not expected to affect the pharmacokinetics of EVOTAZ.
Icelandic: Ekki er gert ráð fyrir að lyfjahvörf dolutegravirs hafi áhrif á lyfjahvörf EVOTAZ.
English: No clinically relevant pharmacokinetic differences due to ethnicity have been identified for atazanavir or cobicistat.
Icelandic: Enginn klínískt marktækur munur var á lyfjahvörfum með tilliti til uppruna fyrir atazanavir og cobicistat.
English: Efavirenz decreases atazanavir concentrations and is expected to decrease cobicistat plasma concentrations.
Icelandic: Efavirenz dregur úr þéttni atazanavirs og gert er ráð fyrir því að það dragi úr plasmaþéttni cobicistats.
English: The mechanism of interaction is a reduced solubility of atazanavir with increasing pH related to the presence of anti-acid agent in didanosine buffered tablets.
Icelandic: Verkunarháttur milliverkana er sá að með auknu pH sem tengist sýruhamlandi eiginleikum didanosin stuðpúðataflna dregur úr leysanleika atazanavirs.
English: Telaprevir AUC ↓20% (↓24% Telaprevir Cmax ↓21% (↓26% Telaprevir Cmin ↓15% (↓25% ↓2%) Atazanavir AUC ↑17% (↓3% Atazanavir Cmax ↓15% (↓27% Atazanavir Cmin ↑85% (↑40%
Icelandic: Atazanavir AUC ↑17% (↓3% ↑43%) Atazanavir Cmax ↓15% (↓27% ↓2%) Atazanavir Cmin ↑85% (↑40% ↑144%)
English: Concentrations of these medicinal products may be increased when co-administered with EVOTAZ.
Icelandic: Þéttni þessara lyfja getur aukist þegar þau eru gefin ásamt EVOTAZ.
English: No clinically relevant pharmacokinetic differences due to gender have been identified for atazanavir or cobicistat.
Icelandic: Enginn klínískt marktækur munur var á lyfjahvörfum með tilliti til kyns fyrir atazanavir og cobicistat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT AND BOTTLE LABEL 1.
Icelandic: YTRI UMBÚÐUM TEXTI Á ÖSKJU OG MIÐA Á GLASI
English: When administered in combination, no clear additive or synergistic cardiovascular effects were observed at atazanavir and cobicistat concentrations at least 2-fold higher than the free atazanavir and cobicistat concentrations at the RHD Cmax.
Icelandic: Gefið í samsetningu voru engin viðbótar eða samverkandi áhrif á hjarta og æðar við þéttni atazanavirs og cobicistats sem var a.m.k.
English: Common (may affect up to 1 in 10 people) increased appetite, dysgeusia (impairment of the sense of taste), dry mouth headache, dizziness insomnia (difficulty sleeping), abnormal dreams, somnolence (sleepiness) vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), dyspepsia (indigestion), bloated or distended tummy (abdomen), flatulence (wind) hyperbilirubinaemia (increased levels of bilirubin in the blood) rash fatigue (extreme tiredness)
Icelandic: aukin matarlyst, afbrigðilegt bragðskyn, munnþurrkur höfuðverkur, sundl svefnleysi (svefnerfiðleikar), óeðlilegir draumar, svefnhöfgi (syfja) uppköst, niðurgangur, kviðverkir (verkir og óþægindi í maga), meltingartruflanir, þaninn kviður, uppþemba (loft) aukið bilirúbín í blóði útbrot óhemjumikil þreyta
English: ANTIGOUT Colchicine
Icelandic: Kalsíumgangalokar
English: Co-administration of EVOTAZ with proton pump inhibitors is not recommended.
Icelandic: Samhliða gjöf EVOTAZ og prótonpumpuhemla er ekki ráðlögð.
English: Co-administration of EVOTAZ and elbasvir/grazoprevir is contraindicated because of the expected increase in grazoprevir plasma concentrations and the associated potential increase in the risk of ALT elevations (see section 4.3).
Icelandic: Ekki má gefa EVOTAZ samhliða elbasvir/grazoprevir þar sem gert er ráð fyrir aukinni þéttni grazoprevirs í plasma ásamt hugsanlega aukinni hættu á ALAT hækkun (sjá kafla 4.3).
English: More frequent therapeutic concentration monitoring is recommended for immunosuppressant agents when co-administered with EVOTAZ.
Icelandic: ört með læknanlegri þéttni ónæmisbælandi lyfja þegar þau eru gefin ásamt EVOTAZ.
English: The mechanism of interaction is CYP3A4 inhibition by cobicistat.
Icelandic: Verkunarháttur milliverkunar er CYP3A4 hömlun af völdum cobicistats.
English: Each single agent produced effects on left ventricular contractility and PR prolongation at concentrations at least 35-fold higher than the free atazanavir and cobicistat concentrations at the recommended human dose (RHD) Cmax.
Icelandic: 35-falt hærri en þéttni óbundins atazanavirs og cobicistats við Cmax ráðlagðs skammts hjá mönnum.
English: Hepatobiliary disorders very common jaundice common hyperbilirubinaemia uncommon hepatitis, cholelithiasisa, cholestasisa rare hepatosplenomegaly, cholecystitisa
Icelandic: Hjarta sjaldgæfar torsades de pointesa mjög sjaldgæfar lenging á QTc bilia, bjúgur, hjartsláttarónot
English: CARDIOVASCULAR AGENTS
Icelandic: Lyf við hjartsláttartruflunum
English: Expected: ↔ Atazanavir ↔ Ritonavir
Icelandic: 300 mg/ritonavir
English: Metabolites are then excreted in the bile as either free or glucuronidated metabolites.
Icelandic: Umbrotsefnin skiljast síðan út með galli sem óbundin eða glúkúróneruð umbrotsefni.
English: ANTIDEPRESSANTS Other antidepressants:
Icelandic: Eftirtaldar pakkningastærðir eru fáanlegar:
English: Atazanavir Cmax ↓59% (↓77% Atazanavir Cmin ↓93% (↓95%
Icelandic: Atazanavir AUC ↓74% (↓78% ↓68%) Atazanavir Cmax ↓59% (↓77% ↓49%) Atazanavir Cmin ↓93% (↓95% ↓90%)
English: The mechanism of interaction is CYP3A inhibition by atazanavir and cobicistat.
Icelandic: Verkunarháttur milliverkunar er CYP3A hömlun vegna atazanavirs og cobicistats
English: These antiepileptics are expected to decrease atazanavir and/or cobicistat plasma concentrations.
Icelandic: Gert er ráð fyrir að þessi flogaveikilyf dragi úr plasmaþéttni atazanavirs og/eða cobicistats.
English: ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily)
Icelandic: Grazoprevir 200 mg einu sinni á dag (atazanavir 300 mg / ritonavir 100 mg einu sinni á dag)
English: Co-administration of etravirine and EVOTAZ is expected to decrease atazanavir and cobicistat plasma concentrations.
Icelandic: Gert er ráð fyrir að samhliða gjöf etravirins og EVOTAZ dragi úr plasmaþéttni atazanavirs og cobicistats.
English: Indinavir is associated with indirect unconjugated hyperbilirubinaemia due to inhibition of UGT.
Icelandic: Indinavir tengist óbeint bilirúbínhækkun í blóði (óbundið bilirúbín) vegna bælingar á UGT.
English: Terfenadine
Icelandic: Dreifing
English: Co-administration of EVOTAZ with other protease inhibitors is not recommended.
Icelandic: Samhliða gjöf EVOTAZ og annarra próteasahemla er ekki ráðlögð.
English: Pharmacotherapeutic group: Antivirals for systemic use; antivirals for treatment of HIV infections, combinations.
Icelandic: Veirulyf til altækrar notkunar, veirulyf til meðferðar á HIV sýkingum, blöndur.
English: Interaction not studied with any of the components of EVOTAZ.
Icelandic: Engar rannsóknir á milliverkunum hafa verið gerðar við innihaldsefni EVOTAZ.
English: Co-administration of EVOTAZ with voxilaprevir-containing products is expected to increase the concentration of voxilaprevir.
Icelandic: Gert er ráð fyrir að gjöf EVOTAZ samhliða lyfjum sem innihalda voxilaprevir auki þéttni voxilaprevirs.
English: ANTIMYCOBACTERIALS
Icelandic: BARKSTERAR
English: The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between atazanavir and comparator regimens (see section 4.4).
Icelandic: B eða C var sambærileg milli atazanavirs og samanburðar meðferðarinnar (sjá kafla 4.4).
English: Among the 21 subjects, 3 developed the emtricitabine-associated resistance substitution M184V.
Icelandic: 3 skiptihvarf M184V í tengslum við ónæmi gegn emtricitabini.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Icelandic: Lýsing á útliti EVOTAZ og pakkningastærðir
English: Potential for increased alfuzosin concentrations which can result in hypotension.
Icelandic: Þéttni alfuzosins getur aukist og valdið lágum blóðþrýstingi.
English: System Organ Class Frequency
Icelandic: Líffærakerfi og tíðni
English: 14-OH clarithromycin Cmax ↓72%
Icelandic: Cmax ↓72%
English: Concentrations of these calcium channel blockers may be increased when co-administered with EVOTAZ.
Icelandic: Þéttni þessara kalsíumgangaloka getur aukist við samhliða gjöf EVOTAZ.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 July 2015
Icelandic: 13. júlí 2015
English: Concentrations of dabigatran may be affected upon co-administration with EVOTAZ.
Icelandic: Samhliða gjöf EVOTAZ getur haft áhrif á þéttni dabigatrans.
English: Renal and urinary disorders uncommon nephrolithiasisa, haematuria, proteinuria, pollakiuria, interstitial nephritis, chronic kidney diseasea rare kidney pain
Icelandic: Lifur og gall mjög algengar gula algengar bilirúbínaukning í blóði sjaldgæfar lifrarbólga, gallsteinara, gallteppaa mjög sjaldgæfar lifrar- og miltisstækkun, gallblöðrubólgaa
English: Nevirapine Cmin ↑32% (↑22%
Icelandic: Cmax ↑17% (↑9% ↑25%) Nevirapin Cmin ↑32% (↑22% ↑43%)
English: Indinavir is also associated with indirect (unconjugated) hyperbilirubinaemia due to inhibition of UGT.
Icelandic: Indinavir tengist einnig bilirúbínhækkun í blóði (óbundið bilirúbín) vegna bælingar á UGT.
English: The mechanism of this interaction is CYP3A4 inhibition by atazanavir and cobicistat.
Icelandic: Verkunarháttur þessarar milliverkunar er CYP3A4 hömlun af völdum atazanavirs og cobicistats.
English: The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat.
Icelandic: Verkunarháttur milliverkana er CYP3A4 hömlun vegna atazanavirs og cobicistats.
English: Clinically significant interactions between EVOTAZ and substrates of CYP1A2, CYP2B6, CYP2C9 or CYP2C19 are not expected.
Icelandic: Ekki er gert ráð fyrir milliverkunum EVOTAZ og hvarfefna CYP1A2, CYP2B6, CYP2C9 og CYP2C19 sem skipta klínísku máli.
English: Musculoskeletal and connective tissue disorders
Icelandic: ÆXLISHEMJANDI OG ÓNÆMISBÆLANDI LYF
English: triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety) simvastatin and lovastatin (used to lower blood cholesterol) avanafil (used to treat erectile dysfunction) colchicine (used to treat gout), if you have kidney and/or liver problems ticagrelor (used to reduce the blood clots) grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination, and glecaprevir/pibrentasvir fixed dose combination (used to treat chronic hepatitis C infection)
Icelandic: Lyf sem innihalda grazoprevir þ.m.t. elbasvir/grazoprevir föst skammtasamsetning og glecaprevir/pibrentasvir föst skammtasamsetning (notað við langvinnri lifrarbólgu C)
English: Atazanavir Cmin ↑91% (↑66%
Icelandic: Cmin ↑160% (↑135%
English: The antiretroviral effect of EVOTAZ is due to the atazanavir component.
Icelandic: Andretróveiruáhrif EVOTAZ eru vegna atazanavirs.
English: Plasma levels of cobicistat and consequently of atazanavir may decrease significantly during pregnancy.
Icelandic: Verulega getur dregið úr plasmaþéttni cobicistats og þar af leiðandi atazanavirs á meðgöngu.
English: Co-administration of EVOTAZ and cisapride is contraindicated (see section 4.3).
Icelandic: Ekki á að nota EVOTAZ samhliða cisapriði (sjá kafla 4.3).
English: Fertility
Icelandic: Vincristin
English: 25-O-desacetyl-rifabutin: AUC: ↑525% Cmax: ↑384% Cmin: ↑394%
Icelandic: Heildar rifabutin og 25-O-desacetyl-rifabutin AUC ↑119% (↑78% ↑169%).
English: Rare (may affect up to 1 in 1,000 people) QTc prolongation (irregular heart beat)
Icelandic: Mjög sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum).
English: It is not known whether atazanavir administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
Icelandic: Þegar atazanavir er gefið konum á meðgöngu er ekki vitað hvort það hækki bilirúbín í blóði og valdi gulufárstaugakvilla hjá nýburum og ungbörnum.
English: Co-administration of EVOTAZ and these antiepileptics is contraindicated (see section 4.3).
Icelandic: Ekki á að gefa EVOTAZ samhliða þessum flogaveikilyfjum (sjá kafla 4.3).
English: Adverse Reactions uncommon myalgia, muscle atrophy, arthralgia rare myopathy
Icelandic: Stoðkerfi og bandvefur sjaldgæfar vöðvaþrautir, vöðvarýrnun, liðverkir mjög sjaldgæfar vöðvakvilli
English: Human experience of acute overdose with EVOTAZ is limited.
Icelandic: Takmörkuð reynsla er af bráðri ofskömmtun EVOTAZ hjá mönnum.
English: Concomitant use of St. John's wort with EVOTAZ may be expected to result in significant reduction in plasma levels of cobicistat and atazanavir.
Icelandic: Gera má ráð fyrir að samhliða notkun jóhannesarjurtar og EVOTAZ geti valdið marktækri lækkun á plasmaþéttni atazanavirs.
English: Children < 5 years
Icelandic: Börn < 5 ára
English: Use in children and adolescents (5 to 17 years)
Icelandic: Notkun handa börnum og unglingum (5 til 17 ára)
English: Cufence with food and drink
Icelandic: Notkun Cufence með mat eða drykk
English: Do not stop or change your treatment without speaking with your doctor even if you feel better.
Icelandic: Ekki má hætta meðferð eða breyta henni án samráðs við lækninn, jafnvel þótt þér líði betur.
English: Take this medicine with water only.
Icelandic: Takið lyfið eingöngu með vatni.
English: You must contact your doctor or another health care provider immediately.
Icelandic: Þú verður að hafa samband við lækninn eða annan heilbrigðisstarfsmann tafarlaust.
English: Exposure seems to be highly variable between subjects.
Icelandic: Útsetning virðist vera mjög breytileg milli einstaklinga.
English: Adults (including the elderly)
Icelandic: Fullorðnir (þar með talið aldraðir)
English: Date of first authorisation: 25 July 2019
Icelandic: 25. júlí 2019
English: Your doctor will decide the correct dose for you.
Icelandic: Læknirinn ákvarðar rétta skammta fyrir þig.
English: The doctor may need to increase or decrease your dose of Cufence.
Icelandic: Læknirinn getur þurft að auka eða minnka skammt Cufence.
English: Frequency of monitoring is recommended to be at least twice a year.
Icelandic: Ráðlögð tíðni eftirlits er að minnsta kosti tvisvar á ári.
English: This medicine is for long-term use because Wilson's disease is a life-long condition.
Icelandic: Lyfið er til langtímanotkunar því Wilsons-sjúkdómur er ævilangt ástand.
English: Patients who have difficulties swallowing should contact their doctor.
Icelandic: Sjúklingar sem eiga erfitt með að kyngja skulu hafa samband við lækninn.
English: Univar Solutions BV Schouwburgplein 30 3012 CL Rotterdam The Netherlands
Icelandic: Univar Solutions BV Schouwburgplein 30 3012 CL Rotterdam Holland
English: Do not use if the capsules become sticky or wet.
Icelandic: Notið ekki ef hylkin verða klístruð eða blaut.
English: Do not take it with other drinks or food because they may reduce the medicine's effect.
Icelandic: Ekki taka það með öðrum drykkjum eða matvælum vegna þess að matur og drykkur getur dregið úr áhrifum lyfsins.