FrancophonIA/ELRC3.0 huggingface dataset:
English: FDA Snapshot Outcome HIV-1 RNA < 50 copies/mL Virologic Failure
Slovenian: Izid posnetka stanja, ki ga je opravila FDA HIV-1 RNK < 50 kopij/ml Virološki neuspeh razlika med režimoma zdravljenja
English: Simeprevir may increase darunavir and/or cobicistat plasma concentrations.
Slovenian: Simeprevir lahko zvišuje plazemske koncentracije darunavirja in/ali kobicistata.
English: • emtricitabine, an anti-HIV medicine known as a nucleoside reverse transcriptase inhibitor
Slovenian: • emtricitabin, zdravilo proti virusu HIV, znano kot zaviralec nukleozidne reverzne transkriptaze
English: The active substances are darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.
Slovenian: Učinkovine so darunavir, kobicistat, emtricitabin in alafenidtenofovirat.
English: Alternative anticonvulsants should be considered.
Slovenian: Razmisliti je treba o uporabi drugih antiepileptikov.
English: Therefore, co-administration of Symtuza and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Slovenian: Zato je sočasna uporaba zdravila Symtuza in sildenafila za zdravljenje pljučne arterijske hipertenzije kontraindicirana (glejte poglavje 4.3).
English: Refer to the prescribing information for darunavir for further information.
Slovenian: Za več podatkov glejte navodila za predpisovanje za darunavir.
English: Amiodarone, dronedarone, ivabradine, quinidine, or ranolazine to treat certain heart disorders (e.g. abnormal heart rhythm)
Slovenian: Uporaba zdravila alfuzosin zdravljenje povečane prostate amjodaron, dronedaron, ivabradin, kinidin ali ranolazin zdravljenje določenih bolezni srca(npr. motenj srčnega ritma)
English: Caution is warranted and therapeutic concentration monitoring, if available, is recommended for these antiarrhythmics when co-administered with Symtuza.
Slovenian: Pri sočasni uporabi z zdravilom Symtuzaje potrebna previdnost, priporočljivo je spremljanje terapevtskih koncentracij navedenih antiaritmikov, če so na voljo.
English: No drug interaction trials have been performed using Symtuza.
Slovenian: Z zdravilom Symtuza niso izvedli študije medsebojnega delovanja.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Slovenian: Poleg oportunističnih okužb se lahko po začetku jemanja zdravil za zdravljenje okužbe s HIV zaradi izboljšanja imunskega odziva pojavijo tudi avtoimunske bolezni (bolezni, ki se pojavijo kadar imunski sistem napade zdravo telesno tkivo).
English: For more information consult the cobicistat Summary of Product Characteristics.
Slovenian: Za več podatkov glejte Povzetek glavnih značilnosti zdravila za kobicistat.
English: Patients with co-existing conditions
Slovenian: Bolniki z drugimi boleznimi
English: In double-blind Phase 3 Trial TMC114FD2HTX3001 (AMBER), treatment-naïve patients were randomised to receive either Symtuza (N = 362) or a combination of fixed-dose combination of darunavir and cobicistat and fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (F/TDF) (N = 363) once daily.
Slovenian: V dvojno slepi študiji faze 3 z oznako TMC114FD2HTX3001 (študija AMBER) so predhodno nezdravljene bolnike randomizirali na prejemanje zdravila Symtuza (N = 362) ali na že pripravljeno kombinacijo s fiksnimi odmerki darunavirja in kobicistata ter že pripravljeno kombinacijo s fiksnimi odmerki emtricitabina in dizoproksiltenofovirijevega fumarata (F/TDF) (N = 363) enkrat na dan. Virološki odziv je bil opredeljen kot virusno breme < 50 kopij/ml z enkratno meritvijo stanja (snapshot approach) (glejte Preglednico 5).
English: You should also not take Symtuza with medicines that contain tenofovir disoproxil (e.g. as fumarate, phosphate, or succinate), lamivudine or adefovir dipivoxil, or medicines that require boosting with ritonavir or cobicistat.
Slovenian: Poleg tega zdravila Symtuza ne smete uporabljati skupaj z zdravili, ki vsebujejo dizoproksiltenofovirat (v obliki fumarata, fosfata ali sukcinata), lamivudin ali dipivoksiladefovirat, oziroma z zdravili, ki potrebujejo okrepitev z ritonavirjem ali kobicistatom.
English: Janssen-Cilag A/S Tlf: +45 45 94 82 82 jacdk@its.jnj.com
Slovenian: Danmark Janssen-Cilag A/S Tlf: +45 4594 8282 jacdk@its.jnj.com
English: Based on theoretical considerations DRV/COBI may increase buprenorphine and/or norbuprenorphine plasma concentrations.
Slovenian: Glede na teoretična izhodišča lahko da kombinacija darunavirja/kobicistata zvišuje plazemske koncentracije buprenorfina in/ali norbuprenorfina.
English: These can include, but are not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Slovenian: Znaki in simptomi hudih kožnih reakcij lahko med drugimi vključujejo hud izpuščaj ali izpuščaj z zvišano telesno temperaturo, splošno slabo počutje, utrujenost, bolečine v mišicah ali sklepih, mehurjaste izpuščaje, razjede v ustih, konjunktivitis, hepatitis in/ali eozinofilijo.
English: If a patient vomits more than 1 hour after taking the medicine, the patient does not need to take another dose of Symtuza until the next regularly scheduled time.
Slovenian: Če bolnik bruha po več kot 1 uri od zaužitja zdravila, naj naslednji odmerek zdravila Symtuza vzame po običajnem razporedu.
English: If you vomit within 1 hour of taking the medicine, another dose of Symtuza should be taken with food as soon as possible.
Slovenian: Če bruhate v roku 1 ure od zaužitja zdravila, čimprej vzemite dodaten odmerek zdravila Symtuza skupaj s hrano.
English: Week 48 and 96 virologic outcomes in the EMERALD trial are provided in Table 6.
Slovenian: V Preglednici 6 so navedeni virološki izvidi v študiji EMERALD po 48 in 96 tednih.
English: Herbal products St. John's wort (Hypericum Perforatum)
Slovenian: Zdravila rastlinskega izvora šentjanževka (Hypericum Perforatum)
English: HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A inhibitors
Slovenian: Zaviralci serinske proteaze NS3-4A boceprevir
English: General disorders and administration site conditions common asthenia, fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti astenija, utrujenost
English: Immune Reactivation Syndrome
Slovenian: Vnetni sindrom imunske obnove
English: Concomitant use of everolimus and Symtuza is not recommended.
Slovenian: Sočasna uporaba everolimusa in zdravila Symtuza ni priporočljiva.
English: Co-administration of tadalafil for the treatment of pulmonary arterial hypertension with Symtuza is not recommended.
Slovenian: Sočasna uporaba zdravila Symtuza in tadalafila za zdravljenje pljučne arterijske hipertenzije ni priporočljiva.
English: Symtuza should not be used in treatment-experienced patients with one or more DRV-RAMs (see section 5.1) or with HIV-1 RNA ≥ 100,000 copies/mL or CD4+ cell count < 100 cells x 10
Slovenian: Pri bolnikih z izkušnjami, ki imajo eno ali več z rezistenco na darunavir povezanih mutacij (DRVRAM) (glejte poglavje 5.1) ali imajo v plazmi ≥ 100.000 kopij/ml HIV-1 RNK ali število CD4+ celic < 100 celic x 10
English: Digoxin
Slovenian: digoksin
English: Non-clinical data on darunavir reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Slovenian: Predklinični podatki za darunavir na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: If you vomit more than 1 hour after taking the medicine, then you do not need to take another dose of Symtuza until the next regularly scheduled time.
Slovenian: Če bruhate po več kot 1 uri od zaužitja zdravila, vzemite naslednji odmerek zdravila Symtuza po običajnem razporedu.
English: A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Symtuza is required.
Slovenian: Če bolniki z normalno ledvično ali jetrno funkcijo potrebujejo zdravljenje z zdravilom Symtuza, je priporočljivo zmanjšati odmerek kolhicina ali prekiniti zdravljenja z njim.
English: No other metabolites were identifiable.
Slovenian: Prisotnosti drugih presnovkov ni bilo mogoče ugotoviti.
English: The mean baseline plasma HIV-1 RNA and the median baseline CD4+ cell count were 4.48 log10 copies/mL (SD = 0.61) and 453 x 10
Slovenian: Povprečno izhodiščno breme HIV-1 RNK v plazmi je bilo 4,48 log10 kopij/ml (standardna deviacija SD = 0,61), povprečno izhodiščno število celic CD4+ pa 453 x 10
English: Cross-resistance in HIV-1 infected, treatment-naïve and virologically suppressed patients
Slovenian: Navzkrižna odpornost pri bolnikih, okuženih z virusom HIV-1, ki predhodno niso bili zdravljeni oziroma je pri njih prišlo do virološke supresije
English: Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Slovenian: Bolniki, ki imajo sočasno okužbo z virusom HIV in virusom hepatitisa B ali C Pri bolnikih, ki imajo kronični hepatitis B ali C in prejemajo protiretrovirusna zdravila, obstaja povečano tveganje za resne in potencialno smrtno nevarne neželene učinke, povezane z jetri.
English: Co-administration of domperidone with Symtuza is contraindicated.
Slovenian: Sočasna uporaba domperidona in zdravila Symtuza je kontraindicirana.
English: (CYP3A and/or P-glycoprotein inhibition).
Slovenian: (zaviranje CYP3A in/ali P-glikoproteina).
English: The exposure to darunavir and cobicistat administered as the Symtuza was 30-45% lower and 16-29% lower, respectively, in fasted compared to fed condition.
Slovenian: Pri odmerjanju zdravila Symtuza na tešče je bila v primerjavi z odmerjanjem po hrani izpostavljenost darunavirju 30-45% manjša, izpostavljenost kobicistatu pa 16-29% manjša.
English: Therefore, therapy with Symtuza should not be initiated during pregnancy, and women who become pregnant during therapy with Symtuza should be switched to an alternative regimen (see sections 4.2 and 4.4).
Slovenian: Zato se zdravljenja z zdravilom Symtuza ne sme uvesti med nosečnostjo, Ženske, ki med zdravljenjem z zdravilom Symtuza zanosijo, pa morajo preiti na drug režim zdravljenja (glejte poglavji 4.2 in 4.4).
English: 2 consecutive HIV-1 RNA ≥ 50 copies/mL, or in case of discontinuation or at Week 48/96 for any reason, (single) HIV-1 RNA ≥ 50 copies/mL as of baseline (included)
Slovenian: 2 zaporedna izvida HIV-1 RNK ≥ 50 kopij/ml oziroma v primeru predčasne prekinitve ali v 48./96.
English: Contact your doctor or nearest emergency department immediately for advice.
Slovenian: Če ste vzeli večji odmerek zdravilaSymtuza, kot bi smeli Nemudoma se posvetujte z zdravnikom ali poiščite najbližjo urgentno ambulanto.
English: Cobicistat is not expected to induce CYP1A2, CYP3A4, CYP2C9, CYP2C19, UGT1A1, or P-gp (MDR1).
Slovenian: Ne pričakuje se, da bi kobicistat induciral CYP1A2, CYP3A4, CYP2C9, CYP2C19, UGT1A1 ali p-gp (proteina MDR1).
English: However,the safety of components of Symtuza was evaluated through the clinical study TMC114-C230 (N = 12) for darunavir with ritonavir and GS-US-292-0106 (N = 50) for a fixed dose combination containing elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
Slovenian: Varnosti zdravila Symtuza pri pediatričnih bolnikih niso raziskovali, ocenjevali pa so varnost posameznih učinkovin zdravila Symtuza, in sicer varnost darunavirja z ritonavirjem v klinični študiji TMC114-C230 (n = 12) in varnost s fiksno kombinacijo odmerkov, ki je vsebovala elvitegravir, kobicistat, emtricitabin in alafenamidtenofovirat, v študiji GS-US-292-0106 (n = 50).
English: If a missed dose is noticed later than 12 hours of the time it is usually taken, it should not be taken and the patient should resume the usual dosing schedule.
Slovenian: Če je bilo to opaženo več kot 12 ur od časa, ko je odmerek ponavadi zaužit, se izpuščenega odmerka ne sme zaužiti in se nadaljuje z naslednjim odmerkom po običajnem režimu odmerjanja.
English: Therefore, therapy with Symtuza should not be initiated during pregnancy, and women who become pregnant during therapy with Symtuza should be switched to an alternative regimen (see sections 4.4 and 4.6).
Slovenian: Zato se zdravljenja z zdravilom Symtuza ne sme uvesti med nosečnostjo, pri ženskah, ki med zdravljenjem z zdravilom Symtuza zanosijo, je treba razmisliti preiti na drug režim zdravljenja (glejte poglavji 4.4 in 4.6).
English: Patients had no history of virologic failure on darunavir-based regimens, and if historical genotypes were available, absence of darunavir RAMs.
Slovenian: Bolniki v anamnezi niso imeli neuspeha zdravljenja s katerim od režimov z darunavirjem in pri tistih, ki so imeli predhodno določene genotipe, ni bilo prisotnih mutacij, ki bi bile povezane z rezistenco na darunavir.
English: One film-coated tablet of Symtuza once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10
Slovenian: Pri bolnikih, ki so že prejemali protiretrovirusna zdravila in nimajo z rezistenco na darunavir povezanih mutacij (DVD-RAM)*, in imajo v plazmi < 100.000 kopij/ml HIV RNK in število CD4+ celic ≥ 100 celic x 10
English: In case a patient vomits within 1 hour of taking the medicine, another dose of Symtuza should be taken with food as soon as possible.
Slovenian: Če bolnik bruha v roku 1 ure od zaužitja zdravila, naj čimprej vzame dodaten odmerek zdravila Symtuza skupaj s hrano.
English: In rats, ossification changes in the spinal column and sternebrae of fetuses occurred at a dose that produced significant maternal toxicity.
Slovenian: Pri podganah je pri odmerku s pomembnim toksičnim delovanjem na mater prišlo do spremenjenega zakostenevanja hrbtenice in rebrnih nastavkov za razvoj prsnice pri plodu.
English: Subjects with ≥1 emergent RAM, n (%) Protease
Slovenian: Preiskovanci z ≥1 mutacijo RAM, n (%) proteaza reverzna transkriptaza primarna odpornost na PI/DRV
English: There are no pharmacokinetic data on tenofovir alafenamide in patients with eGFRCG < 15 mL/min.
Slovenian: Za bolnike z eGFRCG < 15 ml/min ni na voljo nobenih farmakokinetičnih podatkov o uporabi alafenamidtenofovirata.
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Symtuza.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Symtuza, je priporočljivo skrbno spremljanje bolnika in prilagoditev odmerka metformina.
English: This recommendation is different from ritonavir-boosted darunavir.
Slovenian: Za uporabo darunavirja, okrepljenega z ritonavirjem veljajo drugačna priporočila.
English: Additional adverse drug reactions only seen with darunavir/ritonavir in other trials or postmarketing experience
Slovenian: Preiskave pogosti povečana koncentracije kreatinina v krvi drugi neželeni učinki, ki so jih opažali samo pri uporabi kombinacije darunavirja/kobicistata v drugih preskušanjih ali izkušnjah v obdobju trženja zdravila
English: Imputations according to the TLOVR algorithm.
Slovenian: Time to Loss of Virologic Response, algorithmTLOVR)
English: Week 48 and 96 Virologic Outcomes in EMERALD Trial Week 48
Slovenian: Virološki izidi v študiji EMERALD po 48 in 96 tednih po 48 tednih po 96 tednih*
English: Emtricitabine had demonstrated low carcinogenic potential in mice and rats.
Slovenian: V raziskavah na miših in podganah je emtricitabin izkazoval nizek kancerogeni potencial
English: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Slovenian: Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter poveča koncentracija lipidov in glukoze v krvi (glejte poglavje 4.4).
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with HIV PIs.
Slovenian: Pri bolnikih s hemofilijo tipa A in B, zdravljenih z zaviralci proteaze HIV, so poročali o povečanih krvavitvah, vključno s spontanimi kožnimi hematomi in hemartrozo.. Nekaterim bolnikom so dodajali faktor VIII.
English: Rare side effects (may affect up to 1 in 1,000 people)
Slovenian: Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1000 bolnikov)
English: Increased monitoring for rifabutin associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Slovenian: Zaradi pričakovanega povečanja izpostavljenosti rifabutinu je treba bolnike posebej pozorno opazovati glede neželenih učinkov rifabutina, kar vključuje nevtropenijo in uveitis.
English: Hepatobiliary disorders common hepatic enzyme increased uncommon acute hepatitis a, cytolytic hepatitis
Slovenian: Bolezni jeter, žolčnika in žolčevodov pogosti povišane koncentracije jetrnih encimov občasni akutni hepatitis a, citolitični hepatitis
English: Based on theoretical considerations DRV/COBI may increase the exposure to glecaprevir and pibrentasvir.
Slovenian: Glede na teoretična izhodišča je mogoče pričakovati, da lahko kombinacija darunavirja/kobicistata zveča izpostavljenost glekaprevirju in pibrentasvirju.
English: Following intravenous administration, the volume of distribution of darunavir alone was 88.1 ± 59.0 L (mean ± SD) and increased to 131 ± 49.9 L (mean ± SD) in the presence of 100 mg twice-daily ritonavir.
Slovenian: Po intravenskem dajanju je bil volumen porazdelitve samega darunavirja 88,1 ± 59,0 l (povprečna vrednost ± SD).
English: Discontinuation of Symtuza therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Slovenian: Pri bolnikih s sočasno okužbo z virusom HIV in virusom hepatitisa B je lahko prekinitev zdravljenja z zdravilom Symtuza povezana s hudim akutnim poslabšanjem hepatitisa.
English: It is important to talk to your doctor if you develop a rash.
Slovenian: Če se pri vas pojavi izpuščaj, je pomembno, da se obrnete na zdravnika.
English: The median terminal elimination half-life of tenofovir alafenamide was 0.3 hours when administered as Symtuza.
Slovenian: Po odmerjanju zdravila Symtuza je mediani končni razpolovni čas izločanja alafenamidtenofovirata 0,3 ure.
English: Removing the child resistant cap
Slovenian: Odstranjevanje za otroke varne zaporke
English: The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and OATP1B3.
Slovenian: Aktivnost prenašalcev OATP1B1 in OATP1B3 lahko vpliva na porazdelitev alafenamidtenofovirata po telesu.
English: Limited PK information is available in the elderly (age ≥ 65 years of age) for Symtuza as well as its individual components.
Slovenian: Starostniki Podatki o farmakokinetiki zdravila Symtuza in njenih učinkovin pri starejših ( 65 let) so omejeni.
English: Increased creatine phosphokinase (CPK), myalgia, myositis and rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
Slovenian: Pri uporabi zaviralcev HIV proteaz, še posebej V kombinaciji z NRTI, so poročali o povečanih vrednostih kreatin fosfokinaze (CPK), mialgiji, miozitisu in redko rabdomiolizi.
English: ANTIMYCOBACTERIALS Rifampicin
Slovenian: UČINKOVINE ZA ZDRAVLJENJE INFEKCIJ Z MIKOBAKTERIJAMI rifampicin
English: Symtuza should be discontinued immediately if signs or symptoms of severe skin reactions develop.
Slovenian: Če se pojavijo znaki ali simptomi hudih kožnih reakcij, je treba zdravljenje z zdravilom Symtuza takoj prekiniti.
English: Caution should be used with co-administration of Symtuza and parenteral midazolam.
Slovenian: Pri sočasni uporabi zdravila Symtuza in parenteralne oblike midazolama je potrebna previdnost.
English: Symtuza should not be administered concomitantly with medicinal products containing tenofovir disoproxil (e.g. fumarate, phosphate, or succinate), lamivudine, or adefovir dipivoxil used for the treatment of HBV infection.
Slovenian: Zdravila Symtuza se ne sme uporabljati sočasno z zdravili, ki vsebujejo dizoproksiltenofovirat (v obliki fumarata), lamivudin ali dipivoksiladefovirat za zdravljenje okužbe z virusom hepatitisa B.
English: The concomitante use of Symtuza with these medicinal products is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravila Symtuza in teh zdravil je kontraindicirana (glejte poglavje 4.3).
English: ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
Slovenian: ANTIEPILEPTIKI karbamazepin fenobarbital fenitoin okskarbazepin
English: Emerging resistance in HIV-1 infected, treatment-naïve and virologically suppressed patients
Slovenian: Pojavljanje odpornosti pri bolnikih, okuženih z virusom HIV-1, ki predhodno niso bili zdravljeni ali pa je pri njih prišlo do virološke supresije
English: The bioavailability of the components of Symtuza was not affected when administered orally as a split tablet compared to administration as a tablet swallowed whole.
Slovenian: Na biološko uporabnost posameznih učinkovin zdravila Symtuza ni vplivalo, če so bile peroralno vzete tablete cele ali deljene.
English: Included subjects who had HIV-1 RNA ≥ 50 copies/mL in the Week 48/96 window; subjects who discontinued early due to lack or loss of efficacy per investigator's assessment; subjects who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a HIV-1 RNA ≥ 50 copies/mL.
Slovenian: vključeni so preiskovanci, ki so imeli v časovnem oknu do 48. oziroma do 96. tedna virusno breme HIV-1 RNK ≥ 50 kopij/ml; preiskovanci, ki so predčasno prekinili zdravljenje zaradi nezadostne učinkovitosti ali prenehanja učinkovanja zdravila po presoji raziskovalca; preiskovanci, ki so prekinili zdravljenje zaradi drugega razloga (ne zaradi neželenega učinka smrti ali nezadostne učinkovitosti ali prenehanja učinkovanja zdravila) in so imeli v času prekinitve sodelovanja virusno breme HIV-1 RNK ≥ 50 kopij/ml časovno okno 48 tednov: od 295. do 378. dne; časovno okno 96 tednov: od 631. do 714. dne
English: Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mL Missing data during window but on trial Virologic response (HIV-1-RNA < 50 copies/mL; Snapshot Analysis) by subgroup, n/N (%)
Slovenian: Brez viroloških podatkov Razlogi prekinitev sodelovanja v študiji zaradi neželenega učinka ali smrti prekinitev uporabe študijskega zdravila zaradi drugih razlogov in zadnja razpoložljiva vrednost HIV-1 RNK < 50 kopij/ml ni podatkov za to časovno okno, vendar je bolnik še vključen v študijo Virološki odziv (HIV-1-RNK < 50 kopij/ml; analiza posnetka stanja) po podskupinah, n/N
English: Tenofovir alafenamide
Slovenian: Alafenamidtenofovirat
English: HIV-1 Treatment experienced Patients
Slovenian: Bolniki, ki so bili predhodno že zdravljeni proti HIV-1
English: The bioavailability of all components of Symtuza was comparable to that when darunavir 800 mg, cobicistat 150 mg, and emtricitabine/tenofovir alafenamide 200/10 mg were co-administered as separate formulations; bioequivalence was established following single-dose administration under fed conditions in healthy subjects (N = 96).
Slovenian: Biološka uporabnost vseh učinkovin zdravila Symtuza je bila primerljiva biološki uporabnosti pri sočasni uporabi 800 mg darunavirja, 150 mg kobicistata in 200/10 mg emtricitabina/alafenamidtenofovirata v obliki ločenih formulacij.
English: Based on theoretical considerations DRV/COBI is expected to increase alfentanil plasma concentrations.
Slovenian: Glede na teoretična izhodišča je mogoče pričakovati, da kombinacija darunavir/kobicistat poveča koncentracijo alfentanila v plazmi.
English: Caution is warranted and clinical monitoring is recommended.
Slovenian: Potrebna je previdnost in in klinično spremljanje bolnika.