FrancophonIA/ELRC3.0 huggingface dataset:
English: When co-administration is necessary, do not exceed 10 mg rosuvastatin daily and clinical monitoring for safety (e.g. myopathy) is recommended.
Slovenian: Kadar je potrebno sočasno dajanje, najvišji dnevni odmerek rosuvastatina ne sme preseči 10 mg, zaradi varnosti (npr. miopatija) pa je priporočljivo klinično spremljanje.
English: Table 6: Demographic and baseline disease characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in Study GS-US-216-0114
Slovenian: Preglednica 6: Demografske in začetne značilnosti bolezni odraslih oseb, okuženih z virusom HIV-1, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, v študiji GS-US-216-0114
English: ANTI-INFECTIVES Antifungals Ketoconazole
Slovenian: Antimikotiki ketokonazol
English: Atazanavir + cobicistat + emtricitabine and tenofovir disoproxil fumarate fixed-dose combination was non-inferior in achieving HIV-1 RNA < 50 copies/ml when compared to atazanavir + ritonavir + emtricitabine and tenofovir disoproxil fumarate fixed-dose combination.
Slovenian: Kombinacija atazanavir + kobicistat + sočasno s fiksno kombinacijo emtricitabina in dizoproksiltenofovirat fumarata je bila enakovredna pri doseganju RNA HIV-1 < 50 kopij/ml v primerjavi s kombinacijo atazanavir + ritonavir + sočasno s fiksno kombinacijo emtricitabina in dizoproksiltenofovirat fumarata.
English: Adverse reactions to cobicistat-boosted atazanavir during 144 weeks of clinical trial experience from Study GS-US-216-0114 are listed in Table 3, below, by body system organ class and frequency.
Slovenian: Neželeni učinki za atazanavir, okrepljen s kobicistatom, pridobljeni iz izkušenj 144-tedenske klinične študije GS-US-216-0114, so našteti v spodnji preglednici 3 po organskih sistemih in pogostnosti.
English: How to take Tybost
Slovenian: Kako jemati zdravilo Tybost
English: • feeling sick (nausea)
Slovenian: • občutek siljenja na bruhanje (navzea)
English: Cmin: ↑ 66% Naloxone:
Slovenian: Cmin: ↑ 66 %
English: Pack sizes containing 1 bottle of 30 film-coated tablets or 3 bottles of 30 film-coated tablets.
Slovenian: Velikosti pakiranj vsebujejo 1 plastenko s po 30 filmsko obloženimi tabletami ali 3 plastenke s po 30 filmsko obloženimi tabletami.
English: Co-administration of Tybost and antiretroviral medicinal products Tybost must be co-administered with either atazanavir 300 mg once daily or with darunavir 800 mg once daily (see section 4.2).
Slovenian: Sočasno dajanje zdravila Tybost s protiretrovirusnimi zdravili Zdravilo Tybost je treba uporabiti z bodisi atazanavirjem 300 mg enkrat na dan ali darunavirjem 800 mg enkrat na dan (glejte poglavje 4.2).
English: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Tenofovir disoproxil1
Slovenian: Zaviralci nukleozidne reverzne transkriptaze (NRTI, Nucleoside Reverse Transcriptase Inhibitors) dizoproksiltenofovirat1
English: • kidney stones
Slovenian: • ledvični kamni
English: Co-administration of Tybost with sildenafil for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Slovenian: Sočasno dajanje zdravila Tybost in sildenafila za zdravljenje pljučne arterijske hipertenzije je kontraindicirano (glejte poglavje 4.3).
English: The safety and efficacy of cobicistat with atazanavir in HIV-1 infected patients were evaluated in the randomised, double-blind, active-controlled phase 3 Study GS-US-216-0114 in HIV-1 infected patients with baseline estimated creatinine clearance above 70 ml/min who were treatment-naïve (n = 692).
Slovenian: Varnost in učinkovitost kobicistata z atazanavirjem pri bolnikih, okuženih s HIV-1, so ocenili v randomizirani, dvojno slepi, z učinkovino kontrolirani študiji faze 3 GS-US-216-0114 pri predhodno nezdravljenih bolnikih, okuženih s HIV-1, z izhodiščnim ocenjenim očistkom kreatinina nad 70 ml/min (n = 692).
English: • herbal products: St. John's wort (Hypericum perforatum)
Slovenian: • zdravila rastlinskega izvora: šentjanževka (Hypericum perforatum)
English: Co-administration with Tybost may increase dabigatran plasma concentrations with similar effects as seen with other strong P-gp inhibitors.
Slovenian: Koncentracije dabigatrana v plazmi se lahko pri sočasnem dajanju z zdravilom Tybost zvišajo s podobnimi učinki kot pri drugih močnih zaviralcih P-gp.
English: hyperbilirubinaemia Skin and subcutaneous tissue disorders: Common:
Slovenian: hiperbilirubinemija Bolezni kože in podkožja: Pogosti:
English: No clinically relevant differences in cobicistat pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Slovenian: Klinično pomembnih razlik v farmakokinetičnih lastnostih kobicistata med osebami z zmerno jetrno okvaro in zdravimi osebami niso opazili.
English: It is unknown whether cobicistat/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se kobicistat/presnovki izločajo v materino mleko.
English: Co-administration of cobicistat with dabigatran is contraindicated.
Slovenian: Sočasna uporaba kobicistata z dabigatranom je kontraindicirana.
English: Antiviral efficacy data from randomised controlled studies is available for cobicistat-boosted atazanavir, but not for cobicistat-boosted darunavir (see sections 5.1 and 5.2).
Slovenian: Podatki o protivirusni učinkovitosti iz randomiziranih kontroliranih študij so na voljo samo za atazanavir, okrepljen s kobicistatom, ne pa tudi za darunavir, okrepljen s kobicistatom (glejte poglavji 5.1 in 5.2).
English: Silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose
Slovenian: Jedro tablete silicijev dioksid premreženi natrijev karmelozat magnezijev stearat mikrokristalna celuloza
English: Co-administration of cobicistat and rifabutin is not recommended.
Slovenian: Sočasno dajanje kobicistata in rifabutina se ne priporoča.
English: Concentrations of itraconazole, fluconazole and posaconazole may be increased when co-administered with cobicistat.
Slovenian: Koncentracije itrakonazola, flukonazola in posakonazola se lahko pri sočasnem dajanju s kobicistatom zvišajo.
English: There are limited data from the use of cobicistat and atazanavir in pregnant women.
Slovenian: Podatki o uporabi kobicistata in atazanavirja pri nosečnicah so omejeni.
English: Medicinal products that are extensively metabolised by CYP3A and have high first pass metabolism appear to be the most susceptible to large increases in exposure when co-administered with cobicistat.
Slovenian: Kaže, da so zdravila, ki jih izčrpno presnavlja CYP3A in imajo visoko presnovo prvega prehoda, ob sočasni uporabi s kobicistatom bolj občutljiva na velika povečanja izpostavljenosti.
English: Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Slovenian: Kobicistat se presnavlja z oksidacijo, v kateri posredujeta CYP3A (glavna pot) in CYP2D6 (manj pomembna pot), in se ne glukuronidira.
English: Median baseline CD4+ cell count (range), cells/mm3
Slovenian: Mediano začetno število celic CD4+ (razpon), celic/mm
English: This may stop your medicines from working properly, or may make any side effects worse.
Slovenian: Zato ima lahko zdravilo manjši učinek ali pa se poslabšajo neželeni učinki.
English: Tybost should not be initiated in patients with creatinine clearance less than 70 ml/min if one or more co-administered agent requires dose adjustment based on creatinine clearance (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir).
Slovenian: Zdravila Tybost ni dovoljeno uvesti pri bolnikih z očistkom kreatinina manj kot 70 ml/min, če je treba za eno ali več sočasno dajanih učinkovin odmerek prilagajati na podlagi očistka kreatinina (npr. emtricitabin, lamivudin, tenofovirdizoproksil ali adefovir).
English: Adverse reactions for cobicistat-boosted atazanavir were consistent with the safety profile of ritonavirboosted atazanavir.
Slovenian: Neželeni učinki atazanavirja, okrepljenega s kobicistatom, so bili v skladu z varnostnim profilom atazanavirja, okrepljenega z ritonavirjem.
English: In an analysis of treatment-failure subjects in Study GS-US-216-0114 through week 144, evaluable genotypic data from paired baseline and treatment-failure isolates were available for all 21 virologic failures in the cobicistat group.
Slovenian: V analizi bolnikov, pri katerih je bilo zdravljenje v študiji GS-US-216-0114 do konca 144. tedna neuspešno, so bili v skupini, zdravljeni s kobicistatom, pari genotipskih podatkov izolatov ob začetku zdravljenja in izolatov neuspešnega zdravljenja, ki jih je bilo mogoče oceniti, na voljo za vseh 21 bolnikov z virološkim neuspehom.
English: nephrolithiasis, haematuria, proteinuria General disorders and administration site conditions: Common:
Slovenian: nefrolitiaza, hematurija, proteinurija Splošne težave in spremembe na mestu aplikacije: Pogosti:
English: Co-administration with dabigatran etexilate, a P-glycoprotein (P-gp) substrate, is contraindicated (see section 4.5).
Slovenian: Sočasno dajanje z dabigatran eteksilatom, substratom P-glikoproteina (P-gp), je kontraindicirano (glejte poglavje 4.5).
English: The safety of Tybost in 73 HIV-1 infected treatment-experienced patients with mild to moderate renal impairment (eGFR by Cockcroft-Gault method 50-89 ml/min) who switched pharmacokinetic enhancer from ritonavir to cobicistat was evaluated in an open-label clinical Study (GS-US-236-0118) of cobicistat-boosted atazanavir or darunavir plus two NRTIs.
Slovenian: Varnost zdravila Tybost pri 73 predhodno zdravljenih bolnikih, okuženih z virusom HIV-1 z blago do zmerno ledvično okvaro (eGFR po Cockcroft-Gaultovi metodi 50-89 ml/min), ki so prešli s farmakokinetičnega ojačevalca ritonavirja na kobicistat, je bila ocenjena v odprti klinični študiji (GS-US-236-0118) z atazanavirjem ali darunavirjem, okrepljenim s kobicistatom, sočasno z dvema NRTI.
English: Treatment with cobicistat and darunavir during pregnancy results in lower darunavir exposure.
Slovenian: Zdravljenje s kobicistatom in darunavirjem med nosečnostjo povzroči manjšo izpostavljenost darunavirju.
English: Patients were randomised in a 1:1 ratio to receive either atazanavir 300 mg + cobicistat 150 mg once daily or atazanavir 300 mg + ritonavir 100 mg once daily, each administered with a fixed background regimen containing tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg administered as a fixed-dose combination tablet.
Slovenian: Bolniki so bili randomizirani v razmerju 1:1 v skupino, ki je prejemala atazanavir 300 mg + kobicistat 150 mg enkrat na dan ali v skupino, ki je prejemala atazanavir 300 mg + ritonavir 100 mg enkrat na dan; oboje so dobivali v fiksni osnovni shemi zdravljenja, ki je vsebovala dizoproksiltenofovirat fumarat 300 mg in emtricitabin 200 mg kot so tablete s fiksno kombinacijo.
English: For more information on the side effects of atazanavir or darunavir see the package leaflets for these medicines.
Slovenian: Za več informacij o neželenih učinkih atazanavirja ali darunavirja glejte navodilo za uporabo za ti zdravili.
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Tybost.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Tybost, se priporoča skrbno spremljanje in prilagoditev odmerka metformina.
English: Tybost contains the active substance cobicistat.
Slovenian: Zdravilo Tybost vsebuje učinkovino kobicistat.
English: You should not take Tybost with other medicines containing:
Slovenian: Zdravila, ki se uporabljajo za zdravljenje okužb z virusom HIV: Zdravila Tybost ne smete jemati z drugimi zdravili, ki vsebujejo:
English: Table 5: Pharmacokinetic parameters [mean ± SD (%CV)] of darunavir 800 mg co-administered with cobicistat 150 mg or ritonavir 100 mg once daily
Slovenian: Preglednica 5: Farmakokinetični parametri [povprečje ± SD (% KV)] darunavirja 800 mg, uporabljenega sočasno s kobicistatom 150 mg ali ritonavirjem 100 mg enkrat na dan
English: Table 3: Tabulated summary of adverse reactions to cobicistat-boosted atazanavir based on experience of 144 weeks from phase 3 Study GS-US-216-0114
Slovenian: Preglednica 3: Tabelarični povzetek neželenih učinkov atazanavirja, okrepljenega s kobicistatom, na podlagi izkušenj iz 144-tedenske študije faze 3 GS-US-216-0114
English: Atazanavir or darunavir plasma concentrations may decrease as a consequence of a reduction in cobicistat plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Slovenian: Koncentracije atazanavirja ali darunavirja v plazmi se lahko zmanjšajo kot posledica zmanjšanja koncentracij kobicistata v plazmi, kar lahko povzroči izgubo terapevtskega učinka in razvoj rezistence.
English: Some examples include, but are not limited to, itraconazole, ketoconazole, and voriconazole (see Table 2).
Slovenian: To so med drugim itrakonazol, ketokonazol in vorikonazol (glejte preglednico 2).
English: No dose adjustment of cobicistat is necessary for patients with mild to moderate hepatic impairment.
Slovenian: Prilagajanje odmerka kobicistata za bolnike z blago do zmerno jetrno okvaro ni potrebno.
English: Tybost is used in combination with atazanavir or darunavir, therefore the atazanavir or darunavir Summary of Product Characteristics should be consulted.
Slovenian: Zdravilo Tybost se uporablja v kombinaciji z atazanavirjem ali darunavirjem, zato glejte tudi povzetek glavnih značilnosti zdravila za atazanavir ali darunavir.
English: Tybost 150 mg film-coated tablets
Slovenian: Tybost 150 mg filmsko obložene tablete kobicistat
English: 30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 90 (3 plastenke po 30) filmsko obloženih tablet
English: Other types of medicine: • ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole, medicines used to treat fungal infections
Slovenian: • ketokonazol, itrakonazol, vorikonazol, posakonazol in flukonazol; zdravila, ki se uporabljajo za zdravljenje glivičnih okužb
English: Antiviral efficacy data from randomised controlled studies is available for cobicistat-boosted atazanavir, but not for cobicistat-boosted darunavir (see sections 4.4 and 5.2).
Slovenian: Podatki o protivirusni učinkovitosti iz randomiziranih kontroliranih študij so na voljo samo za atazanavir, okrepljen s kobicistatom, ne pa tudi za darunavir, okrepljen s kobicistatom (glejte poglavji 4.4 in 5.2).
English:  Tell your doctor if you are taking any of these HIV medicines.
Slovenian: • maravirok  Povejte svojemu zdravniku, če uporabljate katero od teh zdravil proti HIV.
English: The safety of cobicistat is based on 144-week data from a phase 3, randomised, active-controlled clinical Study (GS-US-216-0114), in which 692 treatment-naïve patients received at least one dose of cobicistat-boosted atazanavir (n = 344) or ritonavir-boosted atazanavir (n = 348) administered with emtricitabine and tenofovir disoproxil fumarate fixed-dose combination.
Slovenian: Varnost kobicistata temelji na podatkih iz 144-tedenske randomizirane, z učinkovino kontrolirane klinične študije faze 3 (GS-US-216-0114), v kateri je 692 bolnikov, ki se predhodno še ni zdravilo, prejelo vsaj en odmerek atazanavirja, okrepljenega s kobicistatom (n = 344), ali atazanavirja, okrepljenega z ritonavirjem (n = 348), sočasno s fiksno kombinacijo emtricitabina in dizoproksiltenofovirat fumarata.
English: Changes in CD4+ cell counts through 48 and 144 weeks in Study GS-US-216-0114 are presented in Table 8.
Slovenian: Spremembe števila celic CD4+ do konca 48. in 144. tedna v študiji GS-US-216-0114 so predstavljene v preglednici 8.
English: Table 1: Dosing regimens Dose of Tybost
Slovenian: Preglednica 1: Režimi odmerjanja
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: The effect of cobicistat on atazanavir pharmacokinetics was demonstrated in the pharmacokinetic substudy (n = 48) of the phase 3 Study GS-US-216-0114 in which HIV-1 infected patients received atazanavir 300 mg + cobicistat 150 mg or atazanavir 300 mg + ritonavir 100 mg, both in combination with emtricitabine and tenofovir disoproxil fumarate fixed-dose combination.
Slovenian: Učinek kobicistata na farmakokinetiko atazanavirja je bil dokazan v farmakokinetični podštudiji (n = 48) študije GS-US-216-0114 faze 3, v kateri so bolniki, okuženi z virusom HIV-1, prejemali atazanavir 300 mg + kobicistat 150 mg ali atazanavir 300 mg + ritonavir 100 mg, oba sočasno s fiksno kombinacijo emtricitabina in dizoproksiltenofovirat fumarata.
English: • buspirone, clorazepate, diazepam, estazolam, flurazepam, perphenazine, risperidone,
Slovenian: • buspirone, klorazepat, diazepam, estazolam, flurazepam, perfenazin, risperidon, tioridazin, zolpidem; zdravila za zdravljenje bolezni živčevja
English: Co-administration with cobicistat may result in increased sildenafil, tadalafil and vardenafil plasma concentrations, which may result in PDE-5 inhibitorassociated adverse reactions.
Slovenian: Sočasno dajanje s kobicistatom lahko povzroči zvišanje koncentracij sildenafila, tadalafila in vardenafila v plazmi, kar lahko povzroči neželene učinke, povezane z zaviralci PDE-5.
English: Medicines used in treating HIV infection:
Slovenian: ZDRAVILA ZA ZDRAVLJENJE INFEKCIJ
English: In Study GS-US-216-0114, hyperbilirubinaemia (> 1 x ULN) was common: 97.7% in the cobicistatboosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group, and 97.4% in the ritonavir-boosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group through 144 weeks of treatment.
Slovenian: V študiji GS-US-216-0114 je bila do konca 144 tedna zdravljenja hiperbilirubinemija (> 1 x zgornje meje normalne vrednosti (ULN, upper limit of normal) pogosta: 97,7 % v skupini, zdravljeni z atazanavirjem, okrepljenim s kobicistatom, sočasno s fiksno kombinacijo emtricitabina in dizoproksiltenofovirat fumarata, in 97,4 % v skupini, zdravljeni z atazanavirjem, okrepljenim z ritonavirjem, sočasno s fiksno kombinacijo emtricitabina in dizoproksiltenofovirat fumarata.
English: Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Slovenian: Kobicistat je selektivni zaviralec encimskega mehanizma citokroma P450, poddružine CYP3A.
English: Cobicistat co-administered with atazanavir or darunavir should not be used in combination with another antiretroviral agent that requires pharmacoenhancement by means of co-administration with an inhibitor of CYP3A4 to reach the desired therapeutic plasma concentrations (i.e., another protease inhibitor).
Slovenian: Kobicistata se sočasno z atazanavirjem ali darunavirjem ne sme uporabljati v kombinaciji z drugo protiretrovirusno učinkovino, ki jo je treba farmakokinetično okrepiti s sočasnim odmerjanjem zaviralca CYP3A4 za doseganje želenih terapevtskih koncentracij v plazmi (tj. z drugim zaviralcem proteaze).
English: Concentrations of ketoconazole and/or cobicistat may increase with co-administration of cobicistat.
Slovenian: Koncentracije ketokonazola in/ali kobicistata se lahko pri sočasni uporabi s kobicistata zvišajo.
English: If switching pharmacoenhancer from ritonavir to cobicistat, caution is required during the first two weeks of treatment with Tybost, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir as a pharmacoenhancer (see section 4.4).
Slovenian: Pri prehodu s farmakokinetičnega ojačevalca ritonavirja na kobicistat je prva dva tedna zdravljenja z zdravilom Tybost potrebna previdnost, zlasti, če so bili odmerki sočasno uporabljenega zdravila med uporabo ritonavirja kot farmakokinetičnega ojačevalca titrirani ali prilagojeni (glejte poglavje 4.4).
English: Cobicistat has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Slovenian: Kobicistata niso proučevali pri bolnikih s hudo jetrno okvaro (stopnja C po Child-Pughu).
English: Dosing recommendations for such combinations have not been established and may result in decreased plasma concentrations of atazanavir, darunavir and/or the other antiretroviral agents that require pharmacoenhancement leading to loss of antiviral activity and development of resistance.
Slovenian: Priporočil za odmerjanje za takšne kombinacije niso opredelili in sočasno dajanje lahko vodi v zmanjšanje plazemskih koncentracij atazanavirja, darunavirja in/ali drugih protiretrovirusnih učinkovin, ki jih je treba farmakokinetično okrepiti, kar vodi v izgubo protivirusne aktivnosti in razvoj rezistence.
English: Digoxin (0.5 mg single dose)/Cobicistat (150 mg multiple doses)
Slovenian: digoksin (0,5 mg enkratni odmerek)/kobicistat (150 mg večkratni odmerki)
English: Cobicistat is a strong mechanism-based CYP3A inhibitor and is a CYP3A substrate.
Slovenian: Kobicistat je močan zaviralec encimskega mehanizma CYP3A in substrat CYP3A.
English: Tybost contains the azo colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
Slovenian: Zdravilo Tybost vsebuje azobarvilo sončno rumenno FCF (E110), ki lahko povzroči alergijske reakcije.
English: Co-administration of cobicistat with carbamazepine is contraindicated (see section 4.3).
Slovenian: Sočasno dajanje kobicistata s karbamazepinom je kontraindicirano (glejte poglavje 4.3).
English: • Tybost must be taken with atazanavir (300 mg) or darunavir (800 mg).
Slovenian: • Zdravilo Tybost morate jemati skupaj z atazanavirjem (300 mg) ali darunavirjem
English: Concentrations of these sedatives/hypnotics may be increased when co-administered with cobicistat.
Slovenian: Koncentracije teh sedativov/hipnotikov se lahko pri sočasnem dajanju s kobicistatom zvišajo.
English: Table 8: Changes in CD4+ cell counts through weeks 48 and 144 in Study GS-US-216-0114 Week 48
Slovenian: Preglednica 8: Spremembe števila celic CD4+ do konca 48. in 144. tedna v študiji GS-US-216-0114
English: In rats, ossification changes in the spinal column and sternebra of foetuses occurred at a dose that produced significant maternal toxicity.
Slovenian: Pri podganah so se pri odmerku, ki je bil za mater pomembno toksičen, pojavile spremembe v zakostenitvi hrbtenice in sternebre pri plodu.
English: Cobicistat 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.
Slovenian: Kobicistata ni dovoljeno uvesti pri bolnikih z očistkom kreatinina manj kot 70 ml/min, če je treba za katero od sočasno uporabljenih učinkovin (npr. emtricitabin, lamivudin, tenofovirdizoproksil ali adefovir) odmerek prilagajati na podlagi očistka kreatinina.
English: Baseline characteristics and treatment outcomes at weeks 48 and 144 for Study GS-US-216-0114 are presented in Tables 6 and 7, respectively.
Slovenian: Značilnosti ob začetku in izidi zdravljenja v 48. in 144. tednu za študijo GS-US-216-0114 so predstavljeni v preglednicah 6 in 7.
English: It is recommended that the international normalised ratio (INR) be monitored upon co-administration with Tybost.
Slovenian: Pri sočasnem dajanju zdravila Tybost se priporoča spremljanje mednarodnega normaliziranega razmerja (International Normalised Ratio, INR).
English: If switching pharmacoenhancer from ritonavir to cobicistat, caution is required during the first two weeks of treatment with cobicistat, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir as a pharmacoenhancer (see section 4.5).
Slovenian: Pri prehodu s farmakokinetičnega ojačevalca ritonavirja na kobicistat je prva dva tedna zdravljenja s kobicistatom potrebna previdnost, zlasti, če so bili odmerki katerega koli sočasno uporabljenega zdravila med uporabo ritonavirja kot farmakokinetičnega ojačevalca titrirani ali prilagojeni (glejte poglavje 4.5).