FrancophonIA/ELRC3.0 huggingface dataset:
English:  If any of these applies to you, talk to your doctor before taking Stribild.
Slovenian:  Če kar koli od navedenega velja za vas, se pred jemanjem zdravila Stribild posvetujte z zdravnikom.
English: In Study GS-US-236-0123, patients had to have previously only received RAL in combination with FTC/tenofovir disoproxil as their first antiretroviral regimen for at least six months.
Slovenian: V študiji GS-US-236-0123 so bolniki pred tem lahko vsaj zadnjih šest mesecev prejemali samo RAL v kombinaciji s FTC/dizoproksiltenofoviratom kot svoj prvi protiretrovirusni režim.
English: Paediatric patients with renal impairment
Slovenian: Pediatrični bolniki z ledvično okvaro
English: Co-administration of Stribild with medicinal products that are primarily metabolised by CYP3A or CYP2D6, or are substrates of P-gp, BCRP, OATP1B1 or OATP1B3 may result in increased plasma concentrations of those products, which could increase or prolong their therapeutic effect and adverse reactions (see Concomitant use contraindicated and section 4.3).
Slovenian: Sočasno dajanje zdravila Stribild z zdravili, ki jih pretežno presnavljata CYP3A ali CYP2D6 ali so substrati P-gp, BCRP, OATP1B1 ali OATP1B3, lahko povzroči zvišanje koncentracij teh zdravil v plazmi, kar bi lahko povečalo ali podaljšalo njihov terapevtski učinek in neželene učinke (glejte Kontraindicirana sočasna uporaba in poglavje 4.3).
English: The antiviral activity of emtricitabine against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, the MAGI-CCR5 cell line, and peripheral blood mononuclear cells.
Slovenian: Protivirusna aktivnost emtricitabina v primerjavi z laboratorijskimi in kliničnimi izolati HIV-1 je bila ocenjena v limfoblastoidnih celičnih linijah, celični liniji MAGI-CCR5 in v mononuklearnih celicah v periferni krvi.
English: When your supply of Stribild starts to run low, get more from your doctor or pharmacist.
Slovenian: Ko se vaše zaloge zdravila Stribild manjšajo, si ga priskrbite pri svojem zdravniku ali farmacevtu.
English: Therefore, Stribild should not be co-administered with medicinal products that include, but are not limited to, the following (see section 4.5):
Slovenian: Zdravilo Stribild se zato ne sme dajati sočasno z zdravili, ki med drugim vključujejo naslednje (glejte poglavje 4.5):
English: The antiviral activity of tenofovir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, primary monocyte/macrophage cells and peripheral blood lymphocytes.
Slovenian: Protivirusna aktivnost tenofovirja proti laboratorijskim in kliničnim izolatom virusa HIV-1 je bila ocenjena v limfoblastoidnih celičnih linijah, primarnih monocitnih/makrofagnih celicah in limfocitih v periferni krvi.
English: Cobicistat is a strong mechanism-based CYP3A inhibitor and a CYP3A substrate.
Slovenian: Kobicistat je močan zaviralec encimskega mehanizma CYP3A in substrat CYP3A.
English: If serum phosphate is < 0.48 mmol/L (1.5 mg/dL) or creatinine clearance is decreased to < 70 mL/min, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8).
Slovenian: Če je vrednost serumskega fosfata < 0,48 mmol/l (1,5 mg/dl) ali se očistek kreatinina zmanjša na < 70 ml/min, je treba v roku enega tedna ponovno ovrednotiti ledvično funkcijo, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4.8).
English: Cobicistat is metabolised via CYP3A and/or CYP2D6-mediated oxidation and does not undergo glucuronidation.
Slovenian: Kobicistat se presnavlja z oksidacijo, v kateri posredujeta CYP3A in/ali CYP2D6, in se ne glukuronidira.
English: pain1, fatigue
Slovenian: bolečina1, utrujenost
English: Voriconazole3 Posaconazole3 Fluconazole
Slovenian: itrakonazol3 iorikonazol3 posakonazol3 flukonazol
English: Stribild should be discontinued if creatinine clearance declines below 50 mL/min during treatment with Stribild as dose interval adjustment is required for emtricitabine and tenofovir disoproxil and this cannot be achieved with the fixed-dose combination tablet (see sections 4.4 and 5.2).
Slovenian: Zdravljenje z zdravilom Stribild je treba prekiniti, če očistek kreatinina med zdravljenjem z zdravilom Stribild pade pod 50 ml/min, saj je potrebna prilagoditev intervala odmerjanja za emtricitabin in dizoproksiltenofovirat in tega ni mogoče doseči s tableto s fiksno kombinacijo odmerkov (glejte poglavji 4.4 in 5.2).
English: Co-administration with Stribild may lead to decreased elvitegravir and/or cobicistat exposures and loss of therapeutic effect and development of resistance.
Slovenian: Sočasno dajanje z zdravilom Stribild lahko povzroči znižanje izpostavljenosti elvitegravirju in/ali kobicistatu in izgubo terapevtskega učinka in razvoj rezistence.
English: Co-administration of tenofovir disoproxil and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions.
Slovenian: Sočasna uporaba dizoproksiltenofovirata in didanozina ni priporočljiva, saj povzroča povečanje sistemske izpostavljenosti didanozinu za 40-60%, kar lahko poveča tveganje za pojav neželenih učinkov, povezanih z didanozinom (glejte poglavje 4.5).
English: • antivirals, used to treat hepatitis C infection: ledipasvir/sofosbuvir, sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir
Slovenian: • zdravila za zdravljenje virusnih okužb, ki se uporabljajo za zdravljenje okužbe z virusom hepatitisa C: ledipasvir/sofosbuvir, sofosbuvir/velpatasvir in sofosbuvir/velpatasvir/voksilaprevir
English: Co-administration of Stribild and some medicinal products that are primarily metabolised by CYP3A may result in increased plasma concentrations of these products, which are associated with the potential for serious and/or life-threatening reactions such as peripheral vasospasm or ischaemia (e.g., dihydroergotamine, ergotamine, ergometrine), or myopathy, including rhabdomyolysis (e.g., simvastatin, lovastatin), or prolonged or increased sedation or respiratory depression (e.g., orally administered midazolam or triazolam).
Slovenian: Sočasna uporaba zdravila Stribild in nekaterih zdravil, ki jih pretežno presnavlja CYP3A, lahko povzroči zvišane koncentracije teh zdravil v plazmi, kar je povezano z možnimi resnimi in/ali življenjsko nevarnimi učinki, kot so periferni vazospazem ali ishemija (npr. dihidroergotamin, ergotamin, ergometrin) ali miopatija, vključno z rabdomiolizo (npr. simvastatin, lovastatin), ali podaljšanjem oz. povečanjem sedacije ali respiratorne depresije (npr. peroralno dan midazolam ali triazolam).
English: In the clinical studies of Stribild over 144 weeks, 13 (1.9%) subjects in the Stribild group (n = 701) and 8 (2.3%) subjects in the ATV/r+FTC/tenofovir disoproxil group (n = 355) discontinued study drug due to a renal adverse reaction.
Slovenian: V kliničnih študijah z zdravilom Stribild, ki so trajale 144 tednov, je 13 (1,9 %) oseb v skupini z zdravilom Stribild (n = 701) in 8 (2,3 %) osebi v skupini z ATV/r+FTC/dizoproksiltenofoviratom (n = 355) prenehalo sodelovati v študiji zdravila zaradi neželenega učinka na ledvice.
English: • back pain caused by kidney problems, including kidney failure.
Slovenian: • bolečine v križu zaradi ledvične okvare, vključno z ledvično odpovedjo.
English: The mean increase from baseline in CD4+ cell count at Week 48 was 23 cells/mm3.
Slovenian: Povprečno povečanje od začetne vrednosti za CD4+ število celic v 48. tednu je bilo 23 celic/mm3.
English: Table 4: Virologic outcome of randomised treatment of studies GS-US-236-0102 and GS-US-236-0103 at Week 48 (snapshot analysis)a and Week 144b
Slovenian: Preglednica 4: Virološki izid randomiziranega zdravljenja za študiji GS-US-236-0102 in GS-US-236-0103 v 48. tednu (analiza posnetka stanja)a in v 144. tednub
English: increased blood creatinine4
Slovenian: zvišanje kreatinina v krvi 4
English: Among 28 patients receiving 96 weeks of treatment with tenofovir disoproxil, BMD Z-scores declined by -0.341 for lumbar spine and -0.458 for total body.
Slovenian: Med 28 bolniki, ki so se 96 tednov zdravili z dizoproksiltenofoviratom, se je Z-vrednost BMD zmanjšala za -0,341 za ledveno hrbtenico in -0,458 za celo telo.
English: In the Phase 3 studies GS-US-236-0102 and GS-US-236-0103, bone fractures occurred in 27 subjects (3.9%) in the Stribild group, 8 subjects (2.3%) in the EFV/FTC/tenofovir disoproxil group, and 19 subjects (5.4%) in the ATV/r+FTC/tenofovir disoproxil group.
Slovenian: V študijah faze 3, GS-US-236-0102 in GS-US-236-0103, je prišlo do zlomov kosti pri 27 osebah (3,9 %) v skupini z zdravilom Stribild, pri 8 osebah (2,3 %) v skupini z EFV/FTC/dizoproksiltenofoviratom in pri 19 osebah (5,4 %) v skupini z ATV/r+FTC/dizoproksiltenofoviratom.
English: • any signs of inflammation or infection • bone problems
Slovenian: • morebitne znake vnetja ali okužbe • težave s kostmi
English: As in adults, adolescents who experience a confirmed increase in serum creatinine of greater than 26.5 µmol/L (0.3 mg/dL) from baseline should be closely monitored for renal safety (see above).
Slovenian: Kot pri odraslih je treba tudi mladostnike, ki imajo potrjeno povečanje serumskega kreatinina za več kot 26,5 µmol/l (0,3 mg/dl) od izhodišča, natančno spremljati glede ledvične varnosti (glejte zgoraj).
English: Patients who have previously discontinued treatment with tenofovir disoproxil due to renal toxicity, with or without reversal of the effects post-discontinuation, should not be treated with Stribild (see section 4.3).
Slovenian: Bolniki, ki so zdravljenje z dizoproksiltenofoviratom predhodno prekinili zaradi ledvične toksičnosti, z ustavitvijo napredovanja učinkov po prekinitvi ali brez nje, se ne smejo zdraviti z zdravilom Stribild (glejte poglavje 4.3).
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil
Slovenian: ZAVIRALCI FOSFODIESTERAZE TIPA 5 (PDE5)
English: Baseline characteristics and treatment outcomes for both Studies GS-US-236-0102 and GS-US-236-0103 are presented in Tables 3 and 4, respectively.
Slovenian: Značilnosti ob začetku in izidi zdravljenja za obe študiji, GS-US-236-0102 in GS-US-236-0103, so predstavljeni v preglednicah 3 oz. 4.
English: At week 48, 83% of patients in the tenofovir disoproxil treatment group and 92% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/mL.
Slovenian: V 48. tednu je 83 % bolnikov v skupini, zdravljeni z dizoproksiltenofoviratom, in 92 % bolnikov v skupini, zdravljeni s stavudinom ali zidovudinom, imelo koncentracije RNA HIV-1 < 400 kopij/ml.
English: One tenofovir disoproxil treated subject and no stavudine or zidovudine treated subjects experienced significant (> 4%) lumbar spine BMD loss at week 48.
Slovenian: Pri eni osebi, zdravljeni z dizoproksiltenofoviratom, in pri nobeni osebi, zdravljeni s stavudinom ali zidovudinom, se je v 48. tednu pojavila znatna izguba (> 4 %) BMD ledvene hrbtenice.
English: Tenofovir exposures were in the range of those observed in tenofovir disoproxil-containing boosted-protease inhibitor regimens.
Slovenian: Izpostavljenosti tenofovirju so bile v razponu, ki so ga opazili v režimih z okrepljenim zaviralcem proteaze, ki so vsebovali dizoproksiltenofovirat.
English: Pharmacokinetics of emtricitabine and tenofovir disoproxil have not been fully evaluated in hepatitis B and/or C virus co-infected patients.
Slovenian: Farmakokinetične lastnosti emtricitabina in dizoproksiltenofovirata pri bolnikih s sočasno okužbo z virusom hepatitisa B in/ali C niso v celoti ovrednotili.
English: In the Phase 3 Study GS-US-236-0103, bone mineral density (BMD) was assessed in a non-random subset of 120 subjects (Stribild group n = 54; ritonavir-boosted atazanavir (ATV/r) plus emtricitabine (FTC)/tenofovir disoproxil group n = 66).
Slovenian: V študiji faze 3, GS-US-236-0103 so mineralno gostoto kosti (BMD - bone mineral density) ocenili v nerandomizirani podskupini s 120 osebami (skupina z zdravilom Stribild n = 54; skupina z atazanavirjem, okrepljenim z ritonavirjem (ATV/r) in emtricitabinom (FTC)/dizoproksiltenofoviratom n = 66).
English: Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Stribild.
Slovenian: Sočasno dajanje apiksabana, rivaroksabana ali edoksabana in zdravila Stribild se ne priporoča.
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Stribild.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Stribild, se priporoča skrbno spremljanje in prilagoditev odmerka metformina.
English: Stribild renal educational brochure for prescribers of adolescent patients.
Slovenian: izobraževalno brošuro o obravnavi ledvic za zdravilo Stribild za zdravnike, ki zdravilo predpisujejo mladostnikom
English: Stribild should not be administered concomitantly with other medicinal products containing tenofovir disoproxil , lamivudine or adefovir dipivoxil used for the treatment of hepatitis B virus infection, or with other medicinal products containing tenofovir alafenamide.
Slovenian: Zdravila Stribild se ne sme dajati skupaj z drugimi zdravili, ki vsebujejo dizoproksiltenofovirat, lamivudin ali dipivoksiladefovirat, ki se uporabljajo za zdravljenje okužbe z virusom hepatitisa B, ali z drugimi zdravili, ki vsebujejo tenofoviralafenamid.
English: The pharmacokinetics of elvitegravir, cobicistat and tenofovir have been studied in patients with moderate hepatic impairment.
Slovenian: Farmakokinetične lastnosti elvitegravirja, kobicistata in tenofovirja so proučevali pri bolnikih z zmerno jetrno okvaro.
English: • decreased phosphate in your blood
Slovenian: • znižanje količine fosfata v krvi
English: It is recommended that digoxin levels be monitored when digoxin is combined with Stribild.
Slovenian: Pri uporabi digoksina v kombinaciji z zdravilom Stribild se priporoča nadziranje ravni digoksina.
English: The adverse reactions observed in paediatric patients who received treatment with tenofovir disoproxil were consistent with those observed in clinical studies of tenofovir disoproxil in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Slovenian: Neželeni učinki, ki so jih opazili pri pediatričnih bolnikih, zdravljenih z dizoproksiltenofoviratom, so bili skladni s tistimi, ki so jih opazili v kliničnih študijah dizoproksiltenofovirata pri odraslih (glejte poglavje 4.8 Povzetek neželenih učinkov v preglednici in poglavje 5.1).
English: Stribild has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Slovenian: Zdravila Stribild niso proučevali pri bolnikih s hudo jetrno okvaro (stopnja C po Child-Pughu).
English: If serum phosphate is confirmed to be < 0.96 mmol/L (3.0 mg/dL) in any paediatric patient receiving Stribild, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Slovenian: Če je potrjena vrednost fosfatov v serumu < 0,96 mmol/l (3,0 mg/dl) pri katerem koli pediatričnem bolniku, ki dobiva zdravilo Stribild, je treba delovanje ledvic po enem tednu ponovno oceniti, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4.8, proksimalna tubulopatija).
English: Study GS-US-236-0103
Slovenian: Študija GS-US-236-0103
English: Before initiating treatment with Stribild
Slovenian: Pred uvedbo zdravljenja z zdravilom Stribild
English: Study GS-US-236-0102
Slovenian: Študija GS-US-236-0102
English: At peak plasma concentration, the mean plasma to blood drug concentration ratio was ~ 1.0 and the mean semen to plasma drug concentration ratio was ~ 4.0.
Slovenian: Med najvišjo koncentracijo v plazmi je bilo povprečno razmerje med koncentracijo zdravila v plazmi in krvi ~ 1,0 in povprečno razmerje med koncentracijo zdravila v spermi in plazmi ~ 4,0.
English: Co-administration of Stribild and other medicinal products primarily metabolised by CYP3A such as amiodarone, quinidine, cisapride, pimozide, lurasidone, alfuzosin and sildenafil for pulmonary arterial hypertension is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravila Stribild in drugih zdravil, ki jih pretežno presnavlja CYP3A, kot so amiodaron, kinidin, cisaprid, pimozid, lurasidon, alfuzosin in sildenafil za pljučno arterijsko hipertenzijo, je kontraindicirana (glejte poglavje 4.3).
English: There are uncertainties associated with the long-term effects of tenofovir disoproxil bone and renal toxicity.
Slovenian: Z dolgoročnimi učinki dizoproksiltenofovirata na kostno in ledvično toksičnost je povezana negotovost.
English: Patients who have previously discontinued treatment with tenofovir disoproxil due to renal toxicity, with or without reversal of the effects post-discontinuation.
Slovenian: Bolniki, ki so zdravljenje z dizoproksiltenofoviratom predhodno prekinili zaradi ledvične toksičnosti, z ustavitvijo napredovanja učinkov po prekinitvi ali brez nje.
English: The efficacy of Stribild in HIV-1 infected treatment-naïve adult patients is based on the analyses of 144-week data from 2 randomised, double-blinded, active-controlled, Phase 3 studies, GS-US-236-0102 and GS-US-236-0103 (n = 1,408).
Slovenian: Učinkovitost zdravila Stribild pri predhodno nezdravljenih odraslih bolnikih, okuženih s HIV-1, temelji na analizah podatkov v 144. tednu iz 2 randomiziranih, dvojno slepih študij faze 3, kontroliranih z učinkovino, GS-US-236-0102 in GS-US-236-0103 (n = 1.408).
English: Cobicistat has no detectable anti-HIV activity and does not antagonise or enhance the antiviral effects of elvitegravir, emtricitabine, or tenofovir.
Slovenian: Kobicistat nima zaznavne aktivnosti proti HIV in na protivirusne učinke elvitegravirja, emtricitabina ali tenofovirja ne deluje antagonistično niti jih okrepi.
English: The types of renal adverse reactions seen with Stribild were consistent with previous experience with tenofovir disoproxil.
Slovenian: Vrste neželenih učinkov na ledvice, opaženih pri zdravilu Stribild, so bile v skladu s predhodnimi izkušnjami z dizoproksiltenofoviratom.
English: Stribild should be discontinued in patients with confirmed creatinine clearance that falls to < 50 mL/min (since the required dose interval adjustments are not possible using this fixed dose combination tablet) or with decreases in serum phosphate to < 0.32 mmol/L (1.0 mg/dL) (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih s potrjenim padcem očistka kreatinina na < 50 ml/min (ker potrebne prilagoditve intervala odmerjanja s tableto s fiksno kombinacijo odmerkov ni mogoče doseči) ali z zmanjšanjem serumskega fosfata na < 0,32 mmol/l (1,0 mg/dl) je treba zdravljenje z zdravilom Stribild prekiniti (glejte poglavji 4.4 in 5.2).
English: Elvitegravir is metabolised by CYP3A and, to a minor extent, by UGT1A1.
Slovenian: Elvitegravir presnavljata CYP3A in v manjši meri UGT1A1.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Slovenian: Pri ugotovljeni imunski reaktivaciji so poročali tudi o pojavu avtoimunskih bolezni (kot sta Gravesova bolezen in avtoimunski hepatitis), vendar pa je poročani čas do pojava različen in se ti dogodki lahko pojavijo več mesecev po uvedbi zdravljenja.
English: In HIV-1 infected adolescents (aged 12 to < 18 years), the BMD Z-scores observed in subjects who received tenofovir disoproxil were lower than those observed in subjects who received placebo.
Slovenian: Pri mladostnikih, okuženih s HIV-1 (starih od 12 do < 18 let), so opazili manjše Z-vrednosti BMD pri osebah, ki so prejemale dizoproksiltenofovirat, kot pri osebah, ki so prejemale placebo.
English: During treatment with Stribild
Slovenian: Med zdravljenjem z zdravilom Stribild
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of treatment.
Slovenian: Pri sumu ali odkritju ledvičnih anomalij je treba pridobiti mnenje nefrologa za razmislek o prekinitvi zdravljenja.
English: The hormonal contraceptive should contain at least 30 µg ethinyloestradiol and contain drospirenone or norgestimate as the progestogen or patients should use an alternative reliable method of contraception (see sections 4.4 and
Slovenian: Hormonski kontraceptiv mora vsebovati vsaj 30 µg etinilestradiola in drospirenon ali norgestimat kot progestogen, ali pa morajo bolnice uporabljati alternativno zanesljivo metodo kontracepcije (glejte poglavji 4.4 in 4.6).
English: Assessment of adverse reactions related to tenofovir disoproxil is based on two randomised trials (studies GS-US-104-0321 and GS-US-104-0352) in 184 HIV-1 infected paediatric patients (aged 2 to < 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1).
Slovenian: Ocena neželenih učinkov, povezanih z dizoproksiltenofoviratom, temelji na dveh randomiziranih preskušanjih (študiji GS-US-104-0321 in GS-US-104-0352) pri 184 pediatričnih bolnikih, okuženih s HIV-1 (starih od 2 do < 18 let), ki so 48 tednov prejemali dizoproksiltenofovirat (n = 93) ali placebo/aktivno primerjavo (n = 91) v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 5.1).
English: Stribild contains lactose
Slovenian: Zdravilo Stribild vsebuje laktozo
English: Stribild is not recommended in this population (see section 4.2).
Slovenian: Uporaba zdravila Stribild pri tej populaciji ni priporočljiva (glejte poglavje 4.2).
English: The potential risks and benefits associated with co-administration of ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir with Stribild should be considered, particularly in patients at increased risk of renal dysfunction.
Slovenian: Upoštevati je treba možna tveganja in koristi, povezane s sočasnim dajanjem ledipasvirja/sofosbuvirja, sofosbuvirja/velpatasvirja ali sofosbuvirja/velpatasvirja/voksilaprevirja in zdravila Stribild, še posebej pri bolnikih s povečanim tveganjem ledvične bolezni.
English: That use of Stribild should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Slovenian: Zdravila Stribild naj ne bi uporabljali sočasno oziroma neposredno po uporabi nefrotoksičnih zdravil.
English: Studies with Stribild
Slovenian: Študije z zdravilom Stribild
English: See section 4.4 regarding patients with creatinine clearance that falls below 70 mL/min while on treatment with Stribild.
Slovenian: Glejte poglavje 4.4 za bolnike, pri katerih med zdravljenjem z zdravilom Stribild očistek kreatinina pade pod 70 ml/min.
English: No human data on the effect of Stribild on fertility are available.
Slovenian: Ni podatkov o učinkih zdravila Stribild na sposobnost razmnoževanja pri ljudeh.
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z-score, and -0.184 and -0.027 in total body BMD Z-score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Slovenian: Povprečni spremembi v 48. tednu (konec randomizirane faze) sta bili 0,032 oz. 0,087 za Z-vrednost BMD ledvene hrbtenice in -0,184 oz. -0,027 za Z-vrednost BMD za celo telo za skupino z dizoproksiltenofoviratom oziroma skupino s stavudinom ali zidovudinom.
English: suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness), depression Nervous system disorders: Very common:
Slovenian: samomorilne misli in poskus samomora (pri bolnikih z depresijo ali psihiatrično boleznijo v anamnezi), depresija
English: Concentrations of calcium channel blockers may be increased when co-administered with cobicistat.
Slovenian: Koncentracije blokatorjev kalcijevih kanalčkov se lahko pri sočasni uporabi s kobicistatom zvišajo.