FrancophonIA/ELRC3.0 huggingface dataset:
English: Missing data during window but on study drug a Week 48 window is between day 309 and 378 (inclusive) b Week 144 window is between day 967 and 1,050 (inclusive) c Includes subjects who had ≥ 50 copies/ml in the week 48 or 144 windows; subjects who discontinued early due to lack or loss of efficacy; subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy, and at the time of discontinuation had a viral value of ≥ 50 copies/ml.
Slovenian: V oknu podatki manjkajo, a uporablja študijsko zdravilo a Okno 48. tedna je med 309. in 378. dnevom (vključno z njima) b Okno 144. tedna je med 967. in 1.050. dnevom (vključno z njima) c Vključuje osebe, ki so imele v oknu 48. ali 144. tedna ≥ 50 kopij/ml; osebe, ki so predčasno prekinile sodelovanje zaradi pomanjkanja ali izgube učinkovitosti; osebe, ki so sodelovanje prekinile zaradi razlogov,
English: Cobicistat is primarily metabolised and eliminated by the liver.
Slovenian: Kobicistat v glavnem presnavljajo in izločajo jetra.
English: Tybost must not be used as a pharmacokinetic enhancer of any other HIV-1 protease inhibitor or any other antiretroviral medicinal product that requires boosting since dosing recommendations for such co-administration have not been established and may result in insufficient plasma level of the antiretroviral medicinal product(s) leading to loss of therapeutic effect and development of resistance (see section 4.2).
Slovenian: Zdravila Tybost se ne sme uporabljati kot farmakokinetični ojačevalec katerih koli drugih zaviralcev proteaze HIV-1 ali protiretrovirusnih zdravil, ki jih je treba okrepiti, ker priporočil za takšno sočasno odmerjanje niso opredelili in lahko vodi v nezadostne ravni protiretrovirusnega(ih) zdravil(a) v plazmi, kar vodi v izgubo terapevtskega učinka in razvoj rezistence (glejte poglavje 4.2).
English: Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Slovenian: Pokazalo se je, da kobicistat zmanjšuje ocenjeni očistek kreatinina zaradi zaviranja tubularne sekrecije kreatinina.
English: Orange, round, biconvex, film-coated tablet of diameter 10.3 mm, debossed with “GSI” on one side of the tablet and plain-faced on the other side of the tablet.
Slovenian: Oranžna, okrogla, bikonveksna, filmsko obložena tableta s premerom 10,3 mm, z vtisnjenim znakom "GSI" na eni strani tablete in brez oznak na drugi strani tablete.
English: When administering with cobicistat, the maximum daily dose of itraconazole should not exceed 200 mg per day.
Slovenian: Pri dajanju kobicistata največji dnevni odmerek itrakonazola ne sme preseči 200 mg dnevno.
English: Cobicistat exposures are non-linear and greater than dose-proportional over the range of 50 mg to 400 mg, consistent with a mechanism-based CYP3A inhibitor.
Slovenian: Izpostavljenosti kobicistatu so nelinearne in več kot sorazmerne z odmerkom v razponu od 50 mg do 400 mg, kar je v skladu s tem, da je zaviralec encimskega mehanizma CYP3A.
English: It is recommended to start with the lowest recommended dose of rosuvastatin and titrate based on clinical response while monitoring for safety (e.g. myopathy).
Slovenian: Priporočljivo je začeti z najnižjim priporočljivim odmerkom rosuvastatina in ga titrirati na podlagi kliničnega odziva, obenem pa bolnika spremljati zaradi varnosti (npr. miopatija).
English: Tablet core Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide.
Slovenian: Jedro tablete Premreženi natrijev karmelozat, magnezijev stearat, mikrokristalna celuloza, silicijev dioksid.
English: Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Slovenian: V nasprotju z ritonavirjem kobicistat ni induktor CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ali UGT1A1.
English: What Tybost looks like and contents of the pack
Slovenian: Izgled zdravila Tybost in vsebina pakiranja
English: • high sugar levels in the blood (hyperglycaemia)
Slovenian: • visoka raven sladkorja v krvi (hiperglikemija)
English: For the treatment of erectile dysfunction, it is recommended that a single dose of sildenafil no more than 25 mg in 48 hours, vardenafil no more than 2.5 mg in 72 hours, or tadalafil no more than 10 mg in 72 hours be co-administered with Tybost.
Slovenian: Za zdravljenje erektilne disfunkcije se pri sočasni uporabi z zdravilom Tybost priporoča enkratni odmerek sildenafila največ 25 mg v 48 urah, vardenafila največ 2,5 mg v 72 urah ali tadalafila največ 10 mg v 72 urah.
English: • sedatives/hypnotics: orally administered midazolam, triazolam
Slovenian: • sedativi/hipnotiki: peroralno uporabljeni midazolam, triazolam
English: The steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) following multiple doses of cobicistat in HIV-1 infected subjects (n = 68), respectively, were 1.2 ± 0.3 µg/ml, 10.9 ± 3.8 µg•h/ml, and 0.07 ± 0.07 µg/ml.
Slovenian: Povprečni Cmax, AUCtau in Ctrough (povprečje ± SD) v stanju dinamičnega ravnovesja po večkratnem odmerjanju kobicistata osebam, okuženim z virusom HIV-1 (n = 68), so bili 1,2 ± 0,3 μg/ml, 10,9 ± 3,8 μg•h/ml oz. 0,07 ± 0,07 μg/ml.
English: Treatment with cobicistat and darunavir during pregnancy results in lower darunavir exposure which may be associated with an increased risk of virological failure and an increased risk of mother-to-child transmission of HIV infection.
Slovenian: Zdravljenje s kobicistatom in darunavirjem med nosečnostjo povzroči manjšo izpostavljenost darunavirju, kar je lahko povezano s povečanim tveganjem za virološki neuspeh in povečanim tveganjem za prenos okužbe s HIV z matere na otroka.
English: • anticonvulsants: carbamazepine, phenobarbital, phenytoin
Slovenian: • antikonvulzanti: karbamazepin, fenobarbital, fenitoin
English: • atorvastatin, fluvastatin, pitavastatin, pravastatin and rosuvastatin, medicines used to lower cholesterol
Slovenian: • atorvastatin, fluvastatin, pitavastatin, pravastatin in rosuvastatin; zdravila, ki se uporabljajo za nižanje holesterola
English: See sections 4.2, 4.8 and 5.2.
Slovenian: Glejte poglavji 4.2, 4.8 in 5.2.
English: • salmeterol, a medicine used to treat asthma
Slovenian: • salmeterol; zdravilo, ki se uporablja za zdravljenje astme
English: Co-administration is contraindicated with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Slovenian: Sočasno dajanje je kontraindicirano z zdravili, katerih očistek je močno odvisen od CYP3A in pri katerih so povišane koncentracije v plazmi povezane z resnimi in/ali življenjsko nevarnimi dogodki.
English: Cobicistat is not expected to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9 or CYP2C19.
Slovenian: Ne pričakuje se, da bi kobicistat zaviral CYP1A2, CYP2B6, CYP2C8, CYP2C9 ali CYP2C19.
English: Tybost film-coated tablets are orange, round, biconvex tablets, debossed on one side with “GSI” and plain-faced on the other side of the tablet.
Slovenian: Zdravilo Tybost filmsko obložene tablete so oranžne, okrogle, bikonveksne tablete z vtisnjeno oznako "GSI" na eni strani tablete in brez oznak na drugi strani tablete.
English: • metformin, medicine used for the treatment of type 2 diabetes
Slovenian: • metformin; zdravilo, ki se uporablja za zdravljenje sladkorne bolezni tipa 2
English: Percentage of subjects with viral load
Slovenian: Odstotek oseb s številom celic
English: No human data on the effect of cobicistat on fertility are available.
Slovenian: Podatkov o vplivu kobicistata na plodnost pri ljudeh ni na voljo.
English: Rilpivirine is not expected to affect the plasma concentration of cobicistat.
Slovenian: Ne pričakuje se, da bi rilpivirin vplival na koncentracijo kobicistata v plazmi.
English: Week 144
Slovenian: 48. teden
English: • headache, dizziness
Slovenian: • glavobol, omotičnost
English: Safety and efficacy have not been established for use of cobicistat with either atazanavir or darunavir when used in any other dosing regimen.
Slovenian: Varnost in učinkovitost uporabe kobicistata z bodisi atazanavirjem ali darunavirjem, če se uporabljata v drugih režimih odmerjanja, nista bili dokazani.
English: Do not stop taking Tybost Do not stop taking Tybost without talking to your doctor.
Slovenian: Ne prenehajte jemati zdravila Tybost, ne da bi se posvetovali s svojim zdravnikom.
English: • antiarrhythmics: amiodarone, quinidine
Slovenian: • antiaritmiki: amiodaron, kinidin
English: Some patients have reported dizziness when Tybost was taken with atazanavir or darunavir.
Slovenian: Nekateri bolniki so med jemanjem zdravila Tybost z atazanavirjem ali darunavirjem poročali o omotici.
English: If you accidentally take more than the recommended dose of Tybost you may be at increased risk of experiencing side effects with this medicine (see section 4 of this leaflet).
Slovenian: Če ste pomotoma zaužili odmerek zdravila Tybost, večji od priporočenega, obstaja povečano tveganje za pojav neželenih učinkov (glejte poglavje 4 tega navodila).
English: Co-administration of salmeterol and Tybost is not recommended (see section 4.4).
Slovenian: Sočasnega dajanja zdravila Tybost in salmeterola se ne priporoča (glejte poglavje 4.4).
English: Among the 21 patients, 3 developed the emtricitabine-associated resistance substitution M184V.
Slovenian: Pri 3 od 21 bolnikov se je razvila substitucija M184V, povezana z rezistenco na emtricitabin.
English: (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 oseb)
English: headache, dizziness, somnolence, dysgeusia
Slovenian: glavobol, omotica, somnolenca, disgevzija
English: • bosentan, a medicine used to treat pulmonary arterial hypertension
Slovenian: • bosentan; zdravilo, ki se uporablja za zdravljenje pljučne arterijske hipertenzije
English: Plasma concentrations of these medicinal products may be increased when co-administered with cobicistat, resulting in reduced serum cortisol concentrations.
Slovenian: Plazemske koncentracije teh zdravil se lahko ob sočasnem dajanju zdravila kobicistata povečajo, kar povzroči zmanjšanje serumskih koncentracij kortizola.
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of cobicistat has not been studied.
Slovenian: Učinka hude jetrne okvare (stopnja C po Child-Pughu) na farmakokinetične lastnosti kobicistata niso proučevali.
English: If a patient misses a dose of Tybost by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Slovenian: Tybost za več kot 12 ur, naj bolnik ne nadomesti izpuščenega odmerka in preprosto nadaljuje z jemanjem po običajnem režimu odmerjanja.
English: Co-administration is not recommended (see section 4.4).
Slovenian: Sočasna uporaba se ne priporoča (glejte poglavje 4.4).
English: [Outer packaging only]
Slovenian: [samo na zunanji ovojnini]
English: • ergot derivatives: dihydroergotamine, ergometrine, ergotamine
Slovenian: • derivati ergot-alkaloidov: dihidroergotamin, ergometrin, ergotamin
English: PHOSPHODIESTERASE TYPE-5 (PDE-5) INHIBITORS Sildenafil
Slovenian: ZAVIRALCI FOSFODIESTERAZE TIPA 5 (PDE5)
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.
Slovenian: Pomembnih razlik v farmakokinetičnih lastnostih kobicistata med osebami s hudo ledvično okvaro in zdravimi osebami niso opazili, kar je v skladu z nizkim ledvičnim očistkom kobicistata.
English: vomiting, diarrhoea, dyspepsia, abdominal pain, abdominal distension, flatulence, dry mouth Hepatobiliary disorders: Very common:
Slovenian: bruhanje, driska, dispepsija, bolečine v trebuhu, abdominalna distenzija, flatulenca, suha usta Bolezni jeter, žolčnika in žolčevodov: Zelo pogosti:
English: K65R or K70E, or any primary resistance substitution associated with protease inhibitors.
Slovenian: Pri nobeni osebi se ni razvila substitucija K65R ali K70E, povezana z rezistenco na tenofovir, ali primarna rezistenčna substitucija, povezana z zaviralci proteaze.
English: Therefore, the use of Tybost is not recommended in these patients (see sections 4.2 and 5.2).
Slovenian: Zato se uporabe zdravila Tybost pri teh bolnikih ne priporoča (glejte poglavji 4.2 in 5.2).
English: The doses of Tybost and the co-administered protease inhibitor, atazanavir or darunavir, are presented in Table 1.
Slovenian: Odmerek zdravila Tybost in zaviralca proteaze, ki se daje sočasno, atazanavirja ali darunavirja, je predstavljen v preglednici 1.
English: Co-administration of cobicistat with medicinal products such as dihydroergotamine, ergotamine, ergometrine, orally administered midazolam, triazolam, amiodarone, quinidine, pimozide, lurasidone, alfuzosin, simvastatin, lovastatin, and sildenafil which are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (see section 4.3).
Slovenian: Sočasno dajanje kobicistata z zdravili, kot so dihidroergotamin, ergotamin, ergometrin, peroralno uporabljeni midazolam, triazolam, amiodaron, kinidin, pimozid, lurasidon, alfuzosin, simvastatin, lovastatin in sildenafil, katerih očistek je močno odvisen od CYP3A in pri katerih so zvišane koncentracije v plazmi povezane z resnimi in/ali življenjsko nevarnimi dogodki, je kontraindicirano (glejte poglavje 4.3).
English: Therefore, Tybost should not be co-administered with medicinal products that include, but are not limited to, the following (see sections 4.4 and 4.5):
Slovenian: Zdravila Tybost se zato ne sme dajati sočasno z zdravili, ki med drugim vsebujejo naslednje (glejte poglavji 4.4 in 4.5):
English: Table 4: Pharmacokinetic parameters [mean ± SD (%CV)] of atazanavir in the pharmacokinetic sub-study of phase 3 Study GS-US-216-0114
Slovenian: Preglednica 4: Farmakokinetični parametri [povprečje ± SD (% KV)] atazanavirja v farmakokinetični podštudiji študije faze 3 GS-US-216-0114
English: Following oral administration of cobicistat with food in HIV-1 infected subjects, peak plasma concentrations were observed 4 hours post-dose for cobicistat.
Slovenian: Po peroralnem dajanju kobicistata s hrano osebam, okuženim z virusom HIV-1, so najvišje plazemske koncentracije opazili 4 ure po odmerku kobicistata.
English: Low levels of metabolites are observed in urine and faeces and do not contribute to the CYP3A inhibitory activity of cobicistat.
Slovenian: V urinu in blatu so opazili nizke ravni presnovkov, ki ne prispevajo k aktivnosti kobicistata pri zaviranju CYP3A.
English: The pharmacokinetics of cobicistat in paediatric subjects have not been established.
Slovenian: Farmakokinetične lastnosti kobicistata pri pediatričnih bolnikih niso ugotovljene.
English: ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan
Slovenian: ANTAGONISTI RECEPTORJEV ENDOTELINA
English: Some examples include, but are not limited to, etravirine, efavirenz, nevirapine, and bosentan (see Table 2).
Slovenian: To so med drugim etravirin, efavirenz, nevirapin in bosentan, vendar pa niso omejeni nanje (glejte preglednico 2).
English: Co-administration of cobicistat with medicinal products that induce CYP3A is contraindicated or is not recommended (see sections 4.3 and 4.5) because decreased plasma concentrations of cobicistat could result in plasma levels that are insufficient to achieve adequate pharmacoenhancement of atazanavir or darunavir.
Slovenian: Sočasno dajanje kobicistata z zdravili, ki inducirajo CYP3A, je kontraindicirano ali se ne priporoča (glejte poglavji 4.3 in 4.5), ker lahko zmanjšanje plazemskih koncentracij kobicistata v plazmi vodi v ravni, ki ne zadoščajo za doseganje ustrezne farmakokinetične okrepitve atazanavirja ali darunavirja.
English: PDE-5 inhibitors are primarily metabolised by CYP3A.
Slovenian: Zaviralce PDE-5 presnavlja pretežno CYP3A.
English: Pharmacokinetics of cobicistat have not been fully evaluated in hepatitis B and/or C virus co-infected subjects.
Slovenian: Farmakokinetičnih lastnosti kobicistata pri bolnikih s sočasno okužbo z virusom hepatitisa B in/ali C niso v celoti ovrednotili.
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Slovenian: Na voljo so naslednje velikosti pakiranj: škatle z 1 plastenko s po 30 filmsko obloženimi tabletami in 90 (3 plastenke po 30) filmsko obloženimi tabletami.
English: • another protease inhibitor
Slovenian: • drugega zaviralca proteaze
English: Viruses were known to be susceptible to atazanavir, emtricitabine and tenofovir disoproxil fumarate at baseline.
Slovenian: Za viruse je bilo ob začetku študije znano, da so občutljivi na atazanavir, emtricitabin in dizoproksiltenofovirat fumarat.
English: Median age, years (min-max)
Slovenian: Demografske značilnosti Mediana starost, leta (najmanj-največ)
English: Then take the next dose as usual in combination with atazanavir or darunavir.
Slovenian: Nato vzemite naslednji odmerek v kombinaciji z atazanavirjem ali darunavirjem ob svojem običajnem času.
English: • blood in the urine (haematuria)
Slovenian: • kri v urinu (hematurija)
English: Dose titration may be required for most medicinal products of the SSRI class, when co-administered with Tybost.
Slovenian: Za večino zdravil razreda SSRI bo morda treba pri sočasni uporabi z zdravilom Tybost odmerek titrirati.
English: Eye disorders: Very common:
Slovenian: Očesne bolezni: Zelo pogosti:
English: Concomitant use of cobicistat and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Slovenian: Sočasna uporaba kobicistata in kortikosteroidov, ki se presnavljajo s pomočjo encimov CYP3A (npr. flutikazonpropionat in drugi inhalacijski ali nazalni kortikosteroidi), lahko poveča tveganje za razvoj sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in supresijo nadledvičnih žlez.
English: The most frequently reported adverse reactions to cobicistat-boosted atazanavir were associated with elevated bilirubin levels (see Table 3).
Slovenian: Najpogostejši neželeni učinki, ki so jih poročali za atazanavir, okrepljen s kobicistatom, so bili povezani z zvišanimi ravnmi bilirubina (glejte preglednico 3).
English: HMG Co-A REDUCTASE INHIBITORS Fluvastatin
Slovenian: ZAVIRALCI REDUKTAZE HMG CoA
English: It is recommended that Tybost be administered with food.
Slovenian: Priporoča se uporabo zdravila Tybost skupaj s hrano.
English: Itraconazole Voriconazole Posaconazole Fluconazole
Slovenian: itrakonazol iorikonazol posakonazol flukonazol
English: • ciclosporin, sirolimus and tacrolimus, medicines used to control your body's immune response after a transplant
Slovenian: • ciklosporin, sirolimus in takrolimus; zdravila za nadzor imunskega odziva telesa po presaditvi
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates (such as atazanavir or darunavir) that have limited oral bioavailability and a short half-life due to CYP3A-dependent metabolism.
Slovenian: Zaviranje presnove preko CYP3A s kobicistatom okrepi sistemsko izpostavljenost substratov CYP3A (kot sta atazanavir ali darunavir), ki imajo omejeno peroralno biološko uporabnost in kratek razpolovni čas zaradi presnove, odvisne od CYP3A.
English: The effect of cobicistat on serum creatinine and eGFR in patients switching from ritonavir to cobicistat in Study GS-US-236-0118 was consistent with the effect in treatmentnaïve patients in Study GS-US-216-0114.
Slovenian: Učinek kobicistata na raven kreatinina v serumu in eGFR pri bolnikih, ki so v študiji GS-US-236-0118 z ritonavirja prešli na kobicistat, je bil skladen z učinkom pri bolnikih v študiji GS-US-216-0114, ki se predhodno še niso zdravili.
English: Maraviroc is a substrate of CYP3A and its plasma concentration increases when co-administered with potent CYP3A inhibitors.
Slovenian: Maravirok je substrat CYP3A, njegova koncentracija v plazmi pa se ob sočasni uporabi z močnimi zaviralci CYP3A zviša.
English: Recommendation concerning co-administration with cobicistat 150 mg and atazanavir or darunavir
Slovenian: Priporočilo glede sočasne uporabe s kobicistatom 150 mg in atazanavirjem ali darunavirjem nevirapin
English: Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with cobicistat.
Slovenian: Kobicistat reverzibilno zavira MATE1 in koncentracije metformina se lahko pri sočasnem dajanju s kobicistatom zvišajo.
English: Table 7: Virologic outcome of randomised treatment of Study GS-US-216-0114 at weeks 48 and Week 48a
Slovenian: Preglednica 7: Virološki izid randomiziranega zdravljenja za študijo GS-US-216-0114 v 48. in 144. tednu
English: Therefore, the use of Tybost is not recommended in these patients (see sections 4.4 and 5.2).
Slovenian: Zato se uporabe zdravila Tybost pri teh bolnikih ne priporoča (glejte poglavji 4.4 in 5.2).
English: Tybost contains sunset yellow FCF aluminium lake which may cause allergic reactions.
Slovenian: Zdravilo Tybost vsebuje barvilo sončno rumeno FCF, ki lahko povzroči alergijske reakcije.
English: What you need to know before you take Tybost Do not take Tybost
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Tybost
English: Treatment with cobicistat and darunavir during the second and third trimesters of pregnancy has been shown to result in lower darunavir exposure compared to postpartum.
Slovenian: Dokazano je bilo, da ima zdravljenje s kobicistatom in darunavirjem med drugim in tretjim trimestrom nosečnosti za posledico manjšo izpostavljenost darunavirju v primerjavi s poporodnim obdobjem.
English: Darunavir 800 mg + ritonavir 100 mg once daily (n = 31)
Slovenian: darunavir 800 mg + ritonavir 100 mg enkrat na dan (n = 31)
English: Among the 19 patients, 1 developed the emtricitabine-associated resistance substitution M184V with no tenofovir- or primary protease inhibitor-associated resistance substitutions.
Slovenian: Pri 1 od 19 bolnikov se je razvila substitucija M184V, povezana z rezistenco na emtricitabin brez substitucije, povezane z rezistenco na tenofovir ali primarne rezistenčne substitucije, povezane z zaviralci proteaze.
English: For these neuroleptics, consider reducing the dose of the neuroleptic upon co-administration with Tybost.
Slovenian: Za te nevroleptike je treba razmisliti o zmanjšanju odmerka nevroleptikov pri sočasnem dajanju z zdravilom Tybost.
English: Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Tybost.
Slovenian: Sočasna uporaba apiksabana, rivaroksabana ali edoksabana in zdravila Tybost se ne priporoča.
English: Co-administration with cobicistat may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk..
Slovenian: Sočasno dajanje s kobicistatom lahko povzroči zvišanje koncentracij DOAC v plazmi, zaradi česar se lahko poveča tveganje za krvavitev.
English: • apixaban, edoxaban, rivaroxaban and warfarin, medicines used to prevent and treat blood clots
Slovenian: • apiksaban, edoksaban, rivaroksaban in varfarin; zdravila, ki se uporabljajo za preprečevanje in zdravljenje krvnih strdkov
English: When co-administration is necessary, it is recommended to start with a dose of atorvastatin 10 mg and titrate based on clinical response while monitoring for safety (e.g. myopathy).
Slovenian: Kadar je potrebno sočasno dajanje, je priporočljivo začeti z odmerkom 10 mg atorvastatina in ga titrirati na podlagi kliničnega odziva, obenem pa bolnika spremljati zaradi varnosti (npr. miopatija).
English: There are no or limited clinical data with cobicistat in pregnant women.
Slovenian: Kliničnih podatkov o uporabi kobicistata pri nosečnicah ni oziroma so omejeni.
English: SEDATIVES/HYPNOTICS Buspirone
Slovenian: SEDATIVI/HIPNOTIKI
English: • antimycobacterials: rifampicin
Slovenian: • zdravila za zdravljenje okužb z mikobakterijami: rifampicin