natgillin/translations-raw huggingface dataset:
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue of 2'-deoxycytidine.
Emtricitabin je nukleozidni zaviralec reverzne transkriptaze (nucleoside reverse transcriptase inhibitor, NRTI) in nukleozidni analog 2'-deoksicitidina.
Non-clinical studies of tenofovir alafenamide in rats and dogs revealed bone and kidney as the primary target organs of toxicity.
Predklinične študije alafenamidtenofovirata pri podganah in psih so pokazale, da so primarni tarčni organi za toksično delovanje kosti in ledvice.
Cobicistat is a mechanism-based inhibitor of cytochrome P450 of the CYP3A subfamily.
Kobicistat je zaviralec encimskega mehanizma citokroma P450poddružine CYP3A.
Based on theoretical considerations co-administration of DRV/COBI with these anticoagulants may increase concentrations of the anticoagulant, which may lead to an increased bleeding risk.
Glede na teoretična izhodišča sočasna uporaba kombinacije darunavirja/kobicistata z navedenimi antikoagulanti lahko poveča njihove koncentracije, kar lahko poveča tveganje za krvavitve.
• allergic reactions such as nettle rash (urticaria), itching, decreased appetite (anorexia)
• alergijske reakcije, kot je koprivnica (urtikarija), srbenje
- Rifabutin (against bacterial infections) - Tadalafil, sildenafil, vardenafil (for erectile dysfunction or high blood pressure in the pulmonary circulation) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety) - Perphenazine, risperidone, thioridazine (psychiatric medicines) - Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
- rifabutin (proti bakterijskim okužbam) - tadalafil, sildenafil, vardenafil (za zdravljenje motenj erekcije ali zvišan krvni tlak v pljučnem krvnem obtoku) - amitriptilin, dezipramin, imipramin, nortriptilin, paroksetin, sertralin, trazodon (za zdravljenje depresije in tesnobe) - perfenazin, risperidon, tioridazin (psihiatrična zdravila) - ciklosporin, everolimus, takrolimus, sirolimus (za zaviranje imunskega sistema), ker se lahko spremenijo terapevtski ali neželeni učinki teh zdravil.
Tell your doctor if you take: - Alfentanil (injectable, strong and short-acting, painkiller that is used for surgical procedures) - Carvedilol, metoprolol, timolol (for heart disease) - Warfarin (to reduce clotting of the blood) as its therapeutic effect or side effects may be altered;
Povejte zdravniku, če jemljete: - alfentanil (močno, kratko delujoče protibolečinsko zdravilo za injiciranje, ki se uporablja pri operacijah) - karvedilol, metoprolol, timolol (za srčne bolezni) - varfarin (za zaviranje strjevanja krvi), ker se lahko spremenijo terapevtski ali neželeni učinki tega zdravila.
Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended.
Priporočljiva je uporaba drugih zaviralcev agregacije trombocitov, na katere ne vpliva zaviranje ali indukcija CYP, (npr. prasugrela).
No clinically relevant pharmacokinetic differences due to age have been identified for cobicistat, emtricitabine or tenofovir alafenamide in the age range ≤ 65 years.
Klinično pomembnih razlik, pogojenih s starostjo, v farmakokinetiki kobicistata, emtricitabina oziroma alafenamidtenofovirata v razponu  65 let niso ugotavili.
As limited information is available on the use of Symtuza in patients aged 65 and over, caution should be exercised, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Ker je o uporabi zdravila Symtuza pri bolnikih, ki so stari 65 let ali več, na voljo le malo podatkov, je pri uporabi zdravila potrebna previdnost zaradi večje pogostnosti slabšega delovanja jeter pri starostnikih in zaradi sočasnih bolezni oziroma drugih zdravil, ki jih starostniki sočasno uporabljajo (glejte poglavji 4.2 in 5.2).
Consult the Summary of Product Characteristics for darunavir for further details.
Za dodatne podatke glejte Povzetek glavnih značilnosti zdravila za darunavir.
- Buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, midazolam when used as an injection (medicines to treat trouble with sleeping or anxiety) - Metformin (to treat type 2 diabetes)
- buspiron, klorazepat, diazepam, estazolam, flurazepam, zolpidem, midazolam, v obliki za injiciranje (zdravila za zdravljenje nespečnosti in/ali tesnobe) - metformin (za zdravljenje sladkorne bolezni tipa 2).
In the Phase 3 trial in suppressed treatment-experienced patients (EMERALD Study TMC114IFD3013), 5.1% (39/763) of patients receiving Symtuza experienced rash (most of which were grade 1), none discontinued treatment due to rash.
V preskušanju faze 3 pri bolnikih, ki so že prejemali zdravila in pri katerih je prišlo do virološke supresije, (študija EMERALD z oznako TMC114IFD3013) se je izpuščaj pojavil pri 5,1% (39/763) bolnikov, ki so prejemali zdravilo Symtuza (v večini primerov stopnje 1), nobeden od bolnikov pa zaradi izpuščaja ni prekinil zdravljenja.
Symtuza has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), therefore, Symtuza must not be used in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Uporabe zdravila Symtuza niso preučili pri bolnikih s hudo okvaro jeter (Child-Pugh razreda C), zato se zdravila Symtuza pri teh bolnikih ne sme uporabljati (glejte poglavja 4.3, 4.4 in 5.2).
Thirteen percent of the dose was recovered in the urine as three putative metabolites.
Trinajst odstotkov odmerka so izolirali v urinu v obliki treh domnevnih presnovkov.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Med zdravljenjem okužbe z virusom HIV se lahko poveča telesna masa ter poveča koncentracija lipidov in glukoze v krvi.
Cobicistat is a mechanism based inhibitor of CYP3A, and a weak CYP2D6 inhibitor.
Kobicistat je zaviralec encimskega mehanizma CYP3A in šibak zaviralec CYP2D6.
If you have kidney or liver problems see section ‘Do not combine
Če imate težave z ledvicami in/ali jetri, glejte pod naslovom
After 96 weeks of treatment with Symtuza, the (95% CI) percent changes from baseline in BMD at the hip and spine region were respectively: -0.26 (-0.96; 0.45) % and -0.93 (-1.82; -0.05) %.
Po 96 tednih zdravljenja z zdravilom Symtuza je bila odstotna spremembe kostne gostote od izhodišča (95-odstotni IZ) v predelu kolka -0,26% (-0,96%, 0,45%), v predelu hrbtenice pa -0,93% (-1,82%, -0,05%).
No human data on the effect of darunavir, cobicistat, emtricitabine, or tenofovir alafenamide on fertility are available.
Podatkov o učinkih darunavirja, kobicistata, emtricitabina in alafenamidtenofovirata na plodnost pri ljudeh ni na voljo..
ANTIFUNGALS Clotrimazole Fluconazole Itraconazole
ANTIMIKOTIKI klotrimazol flukonazol itrakonazol izavukonazol posakonazol vorikonazol
Symtuza should be discontinued in patients with eGFRCG that declines below 30 mL/min during treatment (see sections 5.1 and 5.2).
Pri bolnikih, pri katerih se v času zdravljenja eGFRCG zmanjša pod 30 ml/min, je treba zdravljenje z zdravilom Symtuza prekiniti (glejte poglavji 5.1 in 5.2).
Virologic Response, % HIV-1 RNA < 50 copies/mL
Virološki odziv, % HIV-1 RNK < 50 kopij/ml razlika med režimoma zdravljenja
No emergent resistance to E/C/F/TAF (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) was detected through Week 48.
Pri tem do 48. tedna niso opažali razvoja odpornosti na kombinacijo E/C/F/TAF (elvitegravir/kobicistat/emtricitabin/alafenamidtenofovirat).
Co-administration with the following medicinal products due to the potential for serious and/or life-threatening adverse reactions (see section 4.5): - alfuzosin - amiodarone, dronedarone, ivabradine, quinidine, ranolazine - colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - rifampicin - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - dapoxetine - domperidone - naloxegol - pimozide, quetiapine, sertindole, lurasidone (see section 4.5) - triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
Sočasno zdravljenje s katerim koli od naslednjih zdravil zaradi možnosti razvoja resnih in/ali življenje ogrožajočih neželenih učinkov (glejte poglavje 4.5): - alfuzosin - amjodaron, dronedaron, ivabradin, kinidin, ranolazin - kolhicin, kadar ga uporabljajo bolniki z okvaro ledvic in/ali jeter (glejte poglavje 4.5) - rifampicin - alkaloidi ergot (npr. dihidroergotamin, ergometrin, ergotamin, metilergonovin) - dapoksetin - domperidon - naloksegol - pimozid, kvetiapin, sertindol, lurasidon (glejte poglavje 4.5) - triazolam, peroralni midazolam (za previdnostne ukrepe pri parenteralnem odmerjanju midazolama glejte poglavje 4.5) - sildenafil - kadar se uporablja za zdravljenje pljučne arterijske hipertenzije, avanafil,
The antiviral activity of tenofovir alafenamide against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells and CD4+-T lymphocytes.
Protivirusna aktivnost alafenamidtenofovirata proti laboratorijskim in kliničnim izolatom virusa HIV-1 podtipa B je bila ocenjena v limfoblastoidnih celičnih linijah, enojedrnih celicah periferne krvi, primarnih monocitih/makrofagih in limfocitih T CD4+.
Using Cyst C as filtration marker, the median change in estimated glomerular filtration rate calculated using the CKD-EPI (eGFRCKD-EPI Cyst C) formula (N=22) was +4.4 mL/min/1.73 m² with D/C/F/TAF.
Ob uporabi cistatina C kot označevalca filtracije je bila mediana sprememba ocenjene hitrosti glomerulne filtracije, izračunane po formuli CKD-EPI (eGFRCKD-EPI CystC), v skupini D/C/F/TAF (N=22) +4,4 ml/min/1,73 m².
Following administration of tenofovir alafenamide, plasma [
Po dajanju alafenamidtenofovirata je plazemska [
Emtricitabine displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 μM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 μM).
Emtricitabin je izkazoval protivirusno aktivnost v celični kulturi proti podtipom A, B, C, D, E, F in G virusa HIV-1 (z vrednostmi EC50 od 0,007 do 0,075 µM) in za sev specifično aktivnost proti virusu HIV-2 (z vrednostmi EC50 od 0,007 do 1,5 µM).
Low levels of metabolites are observed in urine and feces and do not contribute to the CYP3A inhibitory activity of cobicistat.
V urinu in blatu so izmerili majhne koncentracije presnovkov, ki pa ne prispevajo k aktivnosti kobicistata (k zaviranju CYP3A).
However, there are pharmacokinetic data for the different components of Symtuza, indicating that doses of 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide result in similar exposures in adults and adolescents aged 12 years and older, weighing at least 40 kg.
Po podatkih o farmakokinetiki posameznih učinkovin zdravila Symtuza pa odmerki 800 mg darunavirja, 150 mg kobicistata, 200 mg emtricitabina in 10 mg alafenamidtenofovirata povzročijo približno enako izpostavljenost učinkovinam pri odraslih in pri mladostnikih, starih 12 let ali več in s telesno maso vsaj 40 kg.
• feeling sick (nausea)
• občutek slabosti (navzea).
During the darunavir/ritonavir clinical development program (N = 3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
V kliničnem preskušanju darunavirja/ritonavirja (n = 3.063) se je pri 0,4% bolnikov pojavil hud kožni izpuščaj, ki ga je lahko spremljala zvišana telesna temperatura in/ali povečane koncentracije transaminaz.
All components were rapidly absorbed following oral administration of Symtuza in healthy subjects.
Pri zdravih osebah so se po zaužitju zdravila Symtuza vse učinkovine hitro absorbirale.
Darunavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M (A, B, C, D, E, F, G) and group O primary isolates with EC50 values ranging from < 0.1 to 4.3 nM.
Darunavir je pokazal protivirusno delovanje in vitro proti širokemu razponu primarnih izolatov virusa HIV-1 skupine M (A, B, C, D, E, F, G) in skupine O z vrednostmi EC50 od < 0,1 do 4,3 nM.
No dose adjustment of Symtuza is required in patients with estimated glomerular filtration rate according to the Cockcroft-Gault formula (eGFRCG) ≥ 30 mL/min.
Pri bolnikih z ocenjeno hitrostjo glomerulne filtracije po Cockcroft-Gaultovi formuli (eGFRCG) ≥ 30 ml/min odmerka zdravila Symtuza ni treba prilagajati.
• tenofovir alafenamide, an anti-HIV medicine known as a nucleotide reverse transcriptase inhibitor
• alafenamidtenofovirat, zdravilo proti virusu HIV, znano kot zaviralec nukleotidne reverzne transkriptaze
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 PBMCs.
Protivirusna aktivnost emtricitabina proti laboratorijskim in kliničnim izolatom virusa HIV-1 je bila ocenjena v limfoblastoidnih celičnih linijah, celični liniji MAGI CCR5 in enojedrnih celicah periferne krvi.
The recommended dose regimen in adults and adolescents aged 12 years and older, weighing at least 40 kg, is one tablet taken once daily with food.
Pri odraslih in mladostnikih, ki so stari 12 let ali več in s telesno maso najmanj 40 kg, je priporočeni odmerek ena tableta enkrat na dan skupaj s hrano.
There were insufficient pharmacokinetic data in the clinical trials to determine the effect of hepatitis B and/or C virus infection on the pharmacokinetics of darunavir,cobicistat, emtricitabine, or tenofovir alafenamide (refer to sections 4.4 and 4.8).
Sočasna okužba z virusom hepatitisa B in/ali hepatitisa C V kliničnih preskušanjih niso pridobili dovolj farmakokinetičnih podatkov, da bi lahko ocenili vpliv okužbe z virusom hepatitisa B in/ali hepatitisa C na farmakokinetiko darunavirja, kobicistata, emtricitabina ali alafenamidtenofovirata (glejte poglavji 4.4 in 4.8).
No dose adjustment of Symtuza is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, Symtuza should be used with caution in these patients, as the darunavir and cobicistat components of Symtuza are metabolised by the hepatic system.
Pri bolnikih z blago (Child-Pugh razreda A) ali zmerno okvaro jeter (Child-Pugh razreda B) prilagajanje odmerka ni potrebno, kljub temu pa je pri uporabi zdravila Symtuza pri teh bolnikih potrebna previdnost, saj se darunavir in kobicistat, učinkovini zdravila Symtuza, presnavljata v jetrih.
Tell your doctor immediately, if any of these apply to you.
Zdravniku povejte, če kaj od spodaj navednega velja za vas:
• cobicistat, a booster (enhancer) of darunavir
• kobicistat, ojačevalec (farmakokinetični ojačevalec) učinkov darunavirja
At least 3 oxidative metabolites of darunavir have been identified in humans; all showed activity that was at least 10-fold less than the activity of darunavir against wild type HIV.
Vsi so pokazali najmanj 10-krat manjšo aktivnost proti divjemu tipu virusa HIV v primerjavi z aktivnostjo darunavirja.
Co-administration of cobicistat with medicinal products that are substrates of these transporters can result in increased plasma concentrations of the co-administered medicinal products.
Sočasna uporaba kobicistata z zdravili, ki so substrati teh prenašalcev, lahko povzroči povečanje koncentracij sočasno uporabljenih zdravil.
Based on theoretical considerations DRV/COBI is expected to increase the plasma concentrations of fluvastatin, pitavastatin, pravastatin, lovastatin and simvastatin.
Glede na teoretična izhodišča je mogoče pričakovati, da kombinacija darunavirja/kobicistata zvišuje plazemske koncentracije fluvastatina, pitavastatina, pravastatina, lovastatina in simvastatina.
What Symtuza looks like and contents of the pack Yellow to yellowish-brown capsule shaped film-coated tablet, mentioning “8121” on one side and “JG” on the other side.
Rumena do rumenkasto rjava filmsko obložena tableta v obliki kapsule z vtisnjeno številko “8121” na eni strani in znakom “JG” na drugi strani.
Treatment with darunavir/cobicistat 800/150 mg during the second and third trimester has been shown to result in low darunavir exposure, with a reduction of around 90% in Cmin levels (see section 5.2).
Pokazalo se je, da zdravljenje s kombinacijo darunavir/kobicistat 800/150 mg enkrat na dan, v drugem in tretjem trimesečju nosečnosti povzroča zmanjšanje izpostavljenosti darunavirju z znižanjem vrednosti Cmin za približno 90% (glejte poglavje 5.2).
Based on theoretical considerations boceprevir may decrease darunavir and/or cobicistat plasma concentrations and adversely affect the intracellular activation and clinical antiviral efficacy of tenofovir alafenamide.
Glede na teoretična izhodišča je je mogoče pričakovati, da boceprevir znižuje plazemske koncentracije darunavirja in/ali kobicistata in neugodno vpliva na intracelularno aktivacijo in klinično protivirusno učinkovitost alafenamidtenofovirata.
In addition to the opportunistic infections, autoimmune disorders (when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection, due to an improvement in the body's immune response.
Poleg oportunističnih okužb se lahko po začetku jemanja zdravil za zdravljenje okužbe s HIV zaradi izboljšanja imunskega odziva pojavijo tudi avtoimunske bolezni (ko imunski sistem napade zdravo telesno tkivo).
Concomitant use of everolimus or irinotecan and Symtuza is not recommended.
Sočasna uporaba everolimusa ali irinotekana z zdravilom Symtuza ni priporočljiva.
- Buprenorphine/naloxone, methadone (medicines to treat opioid dependence) - Salmeterol (medicine to treat asthma) - Artemether/lumefantrine (a combination medicine to treat malaria) - Dasatinib, irinotecan, nilotinib, vinblastine, vincristine (medicines to treat cancer) - Prednisone (corticosteroid) - Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension) - Glecaprevir/pibrentasvir, simeprevir, boceprevir (to treat hepatitis C virus infection).
- buprenorfin/nalokson, metadon (zdravila, za zdravljenju odvisnosti od opioidov) - salmeterol (zdravilo za zdravljenje astme) - artemeter/lumefantrin (kombinirano zdravilo za zdravljenje malarije) - dasatinib, irinotekan, nilotinib, vinblastin, vinkristin (zdravila za zdravljenje raka) - prednizon (kortikosteroid) - sildenafil, tadalafil, vardenafil (za zdravljenje motenj erekcije ali bolezni srca in pljuč, ki jo imenujemo pljučna arterijska hipertenzija) - glekaprevir/pibrentasvir, simeprevir, boceprevir (za zdravljenje okužbe z virusom hepatitisa C) - fentanil, oksikodon, tramadol (protibolečinska zdravila) - fesoterodin, solifenacin (zdravili za zdravljenje bolezni sečil).
For patients with renal impairment the Summary of Product Characteristics for clarithromycin should be consulted for the recommended dose.
Podatke o priporočenem odmerku klaritromicina pri bolnikih z okvaro ledvic je treba poiskati v Povzetku glavnih značilnosti zdravila za klaritromicin.
Gastrointestinal disorders very common diarrhoea common vomiting, nausea, abdominal pain, abdominal distension, dyspepsia, flatulence uncommon pancreatitis acute, pancreatic enzymes increased
Bolezni prebavil zelo pogosti driska pogosti bruhanje, navzea, bolečina v trebuhu, napihnjen trebuh, dispepsija, flatulenca občasni akutni pankreatitis, povišane koncentracije encimov trebušne slinavke
During the second trimester of pregnancy, cobicistat Cmax, AUC24h, and Cmin were 50%, 63%, and 83% lower, respectively, as compared with postpartum.
V drugem trimesečju nosečnosti so bile vrednosti Cmax, AUC24h, in Cmin kobicistata za 50%, 63%, oziroma 83% nižje kot po porodu.
In vitro studies have shown that tenofovir alafenamide is metabolised to tenofovir (major metabolite) by cathepsin A in PBMCs (including lymphocytes and other HIV target cells) and macrophages; and by carboxylesterase-1 in hepatocytes.
Študije in vitro so pokazale, da se alafenamidtenofovirat presnavlja v tenofovir (glavni presnovek) s pomočjo katepsina A v enojedrnih celicah periferne krvi (PBMC), kar vključuje limfocite in druge tarčne celice, ki jih prizadene virus HIV, v makrofagih v hepatocitih pa se presnavlja s karboksilesterazo-1.
Each film-coated tablet contains 800 mg darunavir (as ethanolate), 150 mg cobicistat, 200 mg emtricitabine, and 10 mg tenofovir alafenamide (as fumarate).
Ena filmsko obložena tableta vsebuje 800 mg darunavirja (v obliki etanolata), 150 mg kobicistata, 200 mg emtricitabina in 10 mg alafenamidtenofovirata (v obliki fumarata).
C]-darunavir with ritonavir dose, approximately 79.5% and 13.9% of the administered dose of [
C označenega darunavirja z ritonavirjem so v blatu izmerili približno 79,5% danega odmerka darunavirja
When Symtuza is coadministered with a drospirenone-containing product, clinical monitoring is recommended due to the potential for hyperkalaemia.
Pri sočasni uporabi zdravila Symtuza z zdravili, ki vsebujejo drospirenon, je priporočljivo klinično spremljanje bolnika zaradi možne hiperkaliemije.
Skin and subcutaneous tissue disorders very common rash (including macular, maculopapular, papular, erythematous, pruritic rash, generalised rash, and allergic dermatitis)
Bolezni kože in podkožja zelo pogosti izpuščaj (vključno z makuloznim, makulopapuloznim, papuloznim, eritematoznim, pruritičnim izpuščajem, generaliziranim izpuščajem in alergijskim dermatitisom)
C]-emtricitabine, complete recovery of the emtricitabine dose was achieved in urine (approximately 86%) and faeces (approximately 14%).
Po uporabi s C označenega emtricitabina so celotni odmerek emtricitabina izolirali deloma v urinu (približno 86%) in deloma v blatu (približno 14%).
Adverse reactions are listed by system organ class (SOC) and frequency category in Table 2.
V preglednici 2 so neželeni učinki navedeni po organskih sistemih in kategorijah pogostnosti.
During the third trimester of pregnancy, cobicistat Cmax, AUC24h, and Cmin, were 27%, 49%, and 83% lower, respectively, as compared with postpartum.
V tretjem trimesečju nosečnosti so bile vrednosti Cmax, AUC24h, in Cmin kobicistata za 27%, 49% oziroma 83% nižje kot po porodu.
Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets darunavir/cobicistat/emtricitabine/tenofovir alafenamide
Symtuza 800 mg/150 mg/200 mg/10 mg filmsko obložene tablete darunavir/kobicistat/emtricitabin/alafenamidtenofovirat
Co-administration of tenofovir alafenamide with other medicinal products that inhibit P-gp (e.g., cobicistat, ritonavir, ciclosporin) are expected to increase the absorption and plasma concentration of tenofovir alafenamide.
Sočasna uporaba alafenamidtenofovirata z drugimi zdravili, ki zavirajo P-glikoprotein, (npr. kobicistat, ritonavir, ciklosporin) predvidoma poveča absorpcijo alafenamidtenofovirata in poveča njegovo koncentracijo v plazmi.
NARCOTIC ANALGESICS/TREATMENT OF OPIOID DEPENDENCE Buprenorphine/naloxone
OPIOIDI/ ZDRAVLJENJE ODVISNOSTI OD OPIOIDOV buprenorfin/nalokson
Co-administration of amiodarone, dronedarone, ivabradine, quinidine, or ranolazine and Symtuza is contraindicated (see section 4.3).
Sočasna uporaba zdravila Symtuza z amjodaronom, dronedaronom, ivabradinom, kinidinom ali ranolazinom je kontraindicirana (glejte poglavje 4.3).
Co-administration of Symtuza and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and cobicistat and may result in increased plasma concentrations of darunavir and cobicistat (e.g. azole antifungals like clotrimazole).
Sočasno dajanje zdravila Symtuza in nekaterih zdravil, ki zavirajo CYP3A, lahko zmanjša očistek darunavirja in kobicistata in poveča njuni koncentraciji v plazmi (npr. protiglivični azoli, kot je klotrimazol).
No meaningful differences in cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects, consistent with low renal clearance of cobicistat.
Pomembnih razlik v farmakokinetiki kobicistata med osebami s hudo okvaro ledvic in zdravimi osebami niso opažali, kar se ujema z majhnim ledvičnim očistkom kobicistata .