FrancophonIA/ELRC3.0 huggingface dataset:
English: This can happen in some people who take Delstrigo.
Slovenian: Te se lahko pojavijo pri nekaterih ljudeh, ki jemljejo zdravilo Delstrigo.
English: fluconazole itraconazole posaconazole voriconazole
Slovenian: flukonazol itrakonazol posakonazol vorikonazol
English: • lactic acidosis (excess lactic acid in the blood)
Slovenian: • laktacidozo (preveč mlečne kisline v krvi)
English: Discontinuation due to adverse events
Slovenian: Prenehanje uporabe zaradi neželenih učinkov
English: Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Slovenian: Doravirin je piridinonski nenukleozidni zaviralec reverzne transkriptaze (NNRTI) virusa HIV-1 in zavira replikacijo virusa HIV-1 z nekompetitivnim zavrtjem reverzne transkriptaze (RT) virusa HIV-1.
English: Use with CYP3A inducers
Slovenian: Uporaba z induktorji CYP3A
English: • increased levels of lipase
Slovenian: • zvišanje lipaze
English: Monitor blood concentrations of tacrolimus and sirolimus as the dose of these agents may need to be adjusted.
Slovenian: Kontrolirajte koncentracijo takrolimusa oz. sirolimusa v krvi, kajti lahko je potrebna prilagoditev odmerka teh zdravil.
English: • headache, dizziness, sleepiness
Slovenian: • glavobol, omotica, zaspanost
English: In clinical trials
Slovenian: V kliničnih preskušanjih
English: Patients should be informed that fatigue, dizziness, and somnolence have been reported during treatment with Delstrigo (see section 4.8).
Slovenian: Bolnikom je treba povedati, da so med zdravljenjem z zdravilom Delstrigo poročali o utrujenosti, omotici in zaspanosti (glejte poglavje 4.8).
English: • aggression, hallucinations, difficulty adjusting to changes, mood changes, sleep walking
Slovenian: • napadalnost, halucinacije, težave pri prilagajanju spremembam, spremembe razpoloženja, hoja med spanjem
English: Common NNRTI resistant mutations (K103N, Y181C) were not selected in the in vitro study.
Slovenian: Pogosti mutaciji odpornosti proti NNRTI (K103N, Y181C) se v študiji in vitro nista selekcionirali.
English: The efficacy of doravirine is based on the analyses of 96-week data from two randomised, multicentre, double-blind, active controlled Phase 3 trials, (DRIVE-FORWARD and DRIVE-AHEAD) in antiretroviral treatment-naïve, HIV-1 infected subjects (n = 1494).
Slovenian: Ugotovitve o učinkovitosti doravirina temeljijo na analizah 96-tedenskih podatkov dveh randomiziranih, multicentričnih, dvojno slepih, z učinkovino nadzorovanih preskušanj 3. faze (DRIVE-FORWARD in DRIVE-AHEAD), v kateri so bili vključeni s HIV-1 okuženi bolniki, ki predhodno še niso prejemali protiretrovirusnega zdravljenja (n = 1.494).
English: • if you are taking any of the following medicines: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for seizure) - rifampicin, rifapentine (medicines for tuberculosis) - St. John's wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it - mitotane (a medicine to treat cancer) - enzalutamide (a medicine to treat prostate cancer) - lumacaftor (a medicine to treat cystic fibrosis)
Slovenian: • če jemljete katero koli od naslednjih zdravil: karbamazepin, okskarbazepin, fenobarbital, fenitoin (zdravila za zdravljenje epileptičnih napadov), rifampicin, rifapentin (zdravili za zdravljenje tuberkuloze), šentjanževko (Hypericum perforatum, zdravilo rastlinskega izvora za zdravljenje depresije in tesnobe) ali izdelke, ki jo vsebujejo, mitotan (zdravilo za zdravljenje raka), enzalutamid (zdravilo za zdravljenje raka prostate), lumakaftor (zdravilo za zdravljenje cistične fibroze).
English: Treatment emergent doravirine resistance associated substitutions may confer cross-resistance to efavirenz, rilpivirine, nevirapine, and etravirine.
Slovenian: Med zdravljenjem nastale substitucije, povezane z odpornostjo proti doravirinu, lahko povzročijo navzkrižno odpornost proti efavirenzu, rilpivirinu, nevirapinu in etravirinu.
English: Other medicines and Delstrigo
Slovenian: Druga zdravila in zdravilo Delstrigo
English: Doravirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes, as well as NNRTI-resistant HIV-1.
Slovenian: Proti doravirinu odporni sevi so se selekcionirali v celični kulturi začenši z divjim tipom HIV-1 različnega izvora in podtipov, ter tudi s HIV-1, odpornim proti NNRTI.
English: You may require blood tests for several months after stopping treatment.
Slovenian: Morda bodo še več mesecev po koncu zdravljenja potrebne preiskave krvi.
English: • dabrafenib (a medicine to treat skin cancer)
Slovenian: • dabrafenib (zdravilo za zdravljenje kožnega raka),
English: Based on the lamivudine data, Delstrigo is not recommended for patients with CrCl of < 50 mL/min.
Slovenian: Na podlagi podatkov o lamivudinu zdravilo Delstrigo ni priporočljivo za bolnike z očistkom kreatinina < 50 ml/min.
English: Table 4: Efficacy response (< 40 copies/mL, Snapshot approach) in the pivotal studies
Slovenian: Preglednica 4: Odziv učinkovitosti (< 40 kopij/ml, metoda "Snapshot") v ključnih študijah študija DRIVE-FORWARD
English: Do not take Delstrigo if the above applies to you.
Slovenian: Ne vzemite zdravila Delstrigo, če kaj od naštetega velja za vas.
English: A breakpoint for a reduction in susceptibility, yielded by various NNRTI substitutions, that is associated with a reduction in clinical efficacy has not been established (see section 5.1).
Slovenian: Mejna vrednost za zmanjšanje občutljivosti zaradi različnih z NNRTI povezanih substitucij, pri kateri pride do zmanjšanja klinične učinkovitosti, ni ugotovljena (glejte poglavje 5.1).
English: Delstrigo works by preventing HIV from making more viruses in your body.
Slovenian: Zdravilo Delstrigo preprečuje pomnoževanje virusa HIV v telesu.
English: What Delstrigo is and what it is used for What you need to know before you take Delstrigo How to take Delstrigo
Slovenian: Kaj je zdravilo Delstrigo in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Delstrigo Kako jemati zdravilo Delstrigo Možni neželeni učinki
English: In DRIVE-AHEAD, a lower proportion of subjects who discontinued due to an adverse event by Week 48 was seen for the Delstrigo group (3.0 %) compared with the EFV/FTC/TDF group (6.6 %).
Slovenian: V preskušanju DRIVE-AHEAD je bil delež preiskovancev, ki so z zdravljenjem do 48. tedna prenehali zaradi kakšnega neželenega učinka, v skupini z zdravilom Delstrigo manjši (3,0 %) kot v skupini z EFV/FTC/TDF (6,6 %).
English: Rare aggression, hallucination, adjustment disorder, mood altered, somnambulism
Slovenian: Redki agresivnost, halucinacije, motnja prilagajanja, spremenjeno razpoloženje, somnambulizem
English: 3, 84 % were male, 27 % were non-white, 4 % had hepatitis B and/or C virus co-infection, 10 % had a history of AIDS, 20 % had HIV-1 RNA greater than 100,000 copies per mL, 13 % received ABC/3TC and 87 % received FTC/TDF; these characteristics were similar between treatment groups.
Slovenian: 3, 84 % je bilo moških, 27 % je bilo nebelcev, 4 % so imeli sočasno okužbo z virusom hepatitisa B in/ali C, 10 % je imelo v anamnezi aids, 20 % je imelo koncentracijo HIV-1 RNA več kot 100.000 kopij/ml, 13 % jih je prejemalo ABC/3TC in 87 % jih je prejemalo FTC/TDF; te značilnosti so bile med terapevtskima skupinama podobne.
English: In some subjects treated with zidovudine plus didanosine, isolates resistant to multiple RT inhibitors, including lamivudine, have emerged.
Slovenian: Pri nekaterih preiskovancih, zdravljenih z zidovudinom skupaj z didanozinom, so se pojavili izolati, odporni proti več zaviralcem RT, tudi proti lamivudinu.
English: Findings in the rat and monkey studies indicated that there was a substance related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Slovenian: Izsledki študij pri podganah in opicah so pokazali z učinkovino povezano zmanjšanje črevesne absorpcije fosfata z možnim sekundarnim zmanjšanjem MKG.
English: Uncommon aspartate aminotransferase increased, lipase increased, amylase increased, haemoglobin decreased
Slovenian: Občasni zvišanje aspartat-aminotransferaze, zvišanje lipaze, zvišanje amilaze, znižanje hemoglobina
English: At the highest dosage levels, minor effects on indicators of liver and kidney function were seen together with occasional reductions in liver weight.
Slovenian: Ob največjih odmerkih so zabeležili manjše učinke na kazalce delovanja jeter in ledvic, obenem z občasnim zmanjšanjem mase jeter.
English: Findings in repeat-dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use included kidney and bone changes and a decrease in serum phosphate concentration.
Slovenian: Med izsledki študij toksičnosti ponavljajočih se odmerkov pri podganah, psih in opicah ob izpostavljenostih, večjih ali enakih klinični izpostavljenosti, ki so morda pomembni za klinično uporabo, so spremembe na ledvicah in kosteh ter zmanjšanje koncentracije fosfata v serumu.
English: The administration of a single Delstrigo tablet with a high-fat meal to healthy subjects resulted in a 26 % increase in doravirine C24, while AUC and Cmax were not significantly affected.
Slovenian: Uporaba ene tablete zdravila Delstrigo z zelo mastnim obrokom je pri zdravih osebah povečala C24 doravirina za 26 %, AUC in Cmax pa se nista bistveno spremenili.
English: Renal excretion of doravirine is minor.
Slovenian: Ledvično izločanje doravirina je majhno.
English: Less than 0.7 % of tenofovir binds to human plasma proteins in vitro over the range of 0.01 to 25 micrograms per mL.
Slovenian: In vitro se na beljakovine v človeški plazmi v razponu od 0,01 do 25 mikrogramov na ml veže manj kot 0,7 % tenofovirja.
English: Tenofovir disoproxil requires initial diester hydrolysis for conversion to tenofovir and subsequent phosphorylations by cellular enzymes to form tenofovir diphosphate.
Slovenian: Dizoproksiltenofovirat najprej potrebuje hidrolizo diestra, da se spremeni v tenofovir, in nato fosforiliranje s celičnimi encimi, da nastane tenofovirdifosfat.
English: Rare musculoskeletal pain, osteomalacia (manifested as bone pain and infrequently contributing to fractures)*, myopathy*
Slovenian: Redki mišično-skeletna bolečina, osteomalacija (kaže se s kostnimi bolečinami in v redkih primerih pripomore k zlomom)*, miopatija*
English: There are no or limited amount of data from the use of doravirine in pregnant women.
Slovenian: Podatkov o uporabi doravirina pri nosečnicah je malo ali jih sploh ni.
English: Tenofovir disoproxil is efficiently removed by haemodialysis with an extraction coefficient of approximately 54 %.
Slovenian: Hemodializa učinkovito odstrani dizoproksiltenofovirat; ekstrakcijski količnik je približno 54 %.
English: A breakpoint for a reduction in susceptibility, yielded by various NNRTI substitutions, that is associated with a reduction in clinical efficacy has not been established.
Slovenian: Mejna vrednost za zmanjšanje občutljivosti zaradi različnih z NNRTI povezanih substitucij, pri kateri pride do zmanjšanja klinične učinkovitosti, ni ugotovljena.
English: Week 48 outcome (< 40 copies/mL) by baseline factors
Slovenian: Izid po 48 tednih (< 40 kopij/ml) glede na izhodiščne dejavnike
English: Do not remove the desiccant.
Slovenian: Ne odstranite sušila.
English: A documented absence of genotypic resistance (prior to starting first therapy) to doravirine, lamivudine, and tenofovir was part of the inclusion criteria for patients who switched from a PI- or INI-based regimen.
Slovenian: Potrjena odsotnost genotipske odpornosti (pred začetkom prvega zdravljenja) proti doravirinu, lamivudinu in tenofovirju je bila del meril za vključitev pri bolnikih, ki so prešli iz sheme na osnovi zaviralcev proteaz (PIprotease inhibitors) ali zaviralcev integraz (INI - integrase inhibitors).
English: There were insufficient numbers from racial and ethnic groups other than Caucasian to adequately determine potential pharmacokinetic differences among these populations following the administration of tenofovir disoproxil.
Slovenian: Razen belcev ni bilo zadostnega števila preiskovancev iz drugih rasnih in etničnih skupin, da bi lahko ustrezno ugotovili farmakokinetične razlike med temi populacijami po uporabi dizoproksiltenofovirata.
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (BMD) (rats and dogs).
Slovenian: Toksičnost za kosti je bila ugotovljena kot osteomalacija (pri opicah) in kot zmanjšana mineralna kostna gostota (MKG) (pri podganah in psih).
English: Rare dermatitis allergic, rosacea, angioedema* Musculoskeletal and connective tissue disorders Common muscle disorders*
Slovenian: Redki alergijski dermatitis, rozacea, angioedem* Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti mišične motnje*
English: Excipient with known effect Each film-coated tablet contains 8.6 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 8,6 mg laktoze (v obliki monohidrata).
English: Yellow, oval-shaped, tablet of dimensions 21.59 mm x 11.30 mm, debossed with the corporate logo and 776 on one side and plain on the other side.
Slovenian: filmsko obložena tableta rumena, ovalna, 21,59 mm x 11,30 mm velika tableta z vtisnjenim logotipom podjetja in oznako 776 na eni strani in brez oznake na drugi strani
English: The M184I/V lamivudine resistance substitution confers resistance to emtricitabine.
Slovenian: Odpornostna substitucija M184I/V proti lamivudinu daje tudi odpornost proti emtricitabinu.
English: Doravirine is primarily eliminated via oxidative metabolism mediated by CYP3A4.
Slovenian: Doravirin se v prvi vrsti odstrani z oksidativno presnovo preko CYP3A4.
English: Doravirine There is no information on potential acute symptoms and signs of overdose with doravirine.
Slovenian: Podatkov o možnih akutnih simptomih in znakih prevelikega odmerjanja doravirina ni.
English: Method of administration Delstrigo must be taken orally, once daily with or without food and swallowed whole (see section 5.2).
Slovenian: Zdravilo Delstrigo je treba jemati peroralno, enkrat na dan, s hrano ali brez nje; tableto je treba pogoltniti celo (glejte poglavje 5.2).
English: If Delstrigo is co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily.
Slovenian: Če se zdravilo Delstrigo uporablja sočasno z rifabutinom, je treba odmerek doravirina povečati na 100 mg dvakrat na dan.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Slovenian: Poročali so o avtoimunskih boleznih (kot sta Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja (glejte poglavje 4.4).
English: *This adverse reaction was not identified as an adverse reaction associated with doravirine from the Phase 3 clinical studies (DRIVE-FORWARD, DRIVE-AHEAD, DRIVE-SHIFT), but is included in this table as an adverse reaction based on the Summary of Product Characteristics of 3TC and/or TDF.
Slovenian: *Za ta neželeni učinek v kliničnih študijah 3. faze (DRIVE-FORWARD, DRIVE-AHEAD, DRIVE-SHIFT) ni bilo ugotovljeno, da bi bil povezan z doravirinom, a je vključen v preglednico kot neželen učinek na podlagi povzetka glavnih značilnosti zdravila za 3TC in/ali TDF.
English: Subjects whose virus expressed an L74V RT substitution without zidovudine resistance-associated substitutions (n = 8) had reduced response to tenofovir disoproxil.
Slovenian: Preiskovanci, katerih virus je imel izraženo substitucijo RT L74V, brez substitucij, povezanih z odpornostjo proti zidovudinu (n = 8), so imeli manjši odziv na dizoproksiltenofovirat.
English: If your doctor decides you should take these medicines with Delstrigo, your doctor will prescribe a 100 mg tablet of doravirine to be taken daily, approximately 12 hours after your dose of Delstrigo.
Slovenian: Če zdravnik presodi, da morate ta zdravila jemati skupaj z zdravilom Delstrigo, vam bo predpisal 100-mg tablete doravirina, ki jih boste morali jemati vsak dan, in sicer približno 12 ur po odmerku zdravila Delstrigo.
English: Your doctor may check your blood levels or monitor for side effects if you take the following medicines with Delstrigo:
Slovenian: Zdravnik vam bo morda kontroliral koncentracijo v krvi ali vas bo nadzoroval glede neželenih učinkov, če skupaj z zdravilom Delstrigo jemljete katero od naslednjih zdravil:
English: Intracellularly, lamivudine is phosphorylated to its active 5´- triphosphate metabolite, lamivudine triphosphate (3TC-TP).
Slovenian: V celicah se lamivudin fosforilira v aktivni 5'-trifosfatni presnovek, lamivudintrifosfat (3TC-TP).
English: • rifabutin (a medicine to treat some bacterial infections such as tuberculosis)
Slovenian: • rifabutin (zdravilo za zdravljenje nekaterih bakterijskih okužb, na primer tuberkuloze),
English: Repeat dose toxicity
Slovenian: Toksičnost ponavljajočih se odmerkov
English: Tenofovir displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.5-2.2 microM).
Slovenian: Tenofovir je v celični kulturi pokazal protivirusno aktivnost proti HIV-1 kladov A, B, C, D, E, F, G in O (vrednosti EC50 so bile od 0,5 do 2,2 mikroM).
English: Doravirine has a terminal half-life (t1/2) of approximately 15 hours.
Slovenian: Terminalni razpolovni čas (t1/2) doravirina je približno 15 ur.
English: Rare acute kidney injury, renal disorder, calculus urinary, nephrolithiasis, acute renal failure*, renal failure*, acute tubular necrosis*, nephritis (including acute interstitial)*, nephrogenic diabetes insipidus*
Slovenian: Redki akutna okvara ledvic, ledvična motnja, kamen v sečilih, nefrolitiaza, akutna odpoved ledvic*, odpoved ledvic*, akutna tubularna nekroza*, nefritis (vključno z intersticijskim nefritisom)*, nefrogeni diabetes insipidus*
English: Following oral administration of a single 245 mg dose of tenofovir disoproxil to HIV-1-infected subjects in the fasted state, Cmax was achieved in one hour.
Slovenian: Po peroralni uporabi enkratnega 245-miligramskega odmerka dizoproksiltenofovirata na tešče pri osebah, okuženih s HIV-1, je bila Cmax dosežena v eni uri.
English: Tenofovir is eliminated by a combination of glomerular filtration and active tubular secretion with a renal clearance in adults with CrCl greater than 80 mL per minute of 243.5 ± 33.3 mL per minute (mean ± SD).
Slovenian: Tenofovir se izloča s kombinacijo glomerularne filtracije in aktivne tubularne sekrecije; njegov ledvični očistek znaša pri odraslih, ki imajo očistek kreatinina več kot 80 ml na minuto, 243,5 ± 33,3 ml na minuto (povprečje ± standardni odklon).
English: In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor.
Slovenian: V drugih študijah (prospektivnih in presečnih) so najizrazitejše zmanjšanje MKG opažali pri bolnikih, ki so dizoproksiltenofovirat prejemali v shemi, ki je vključevala ojačen zaviralec proteaz.
English: Do not take Delstrigo:
Slovenian: Ne jemljite zdravila Delstrigo:
English: • pain in the chest, feeling cold, pain, thirst
Slovenian: • bolečina v prsnem košu, občutek mraza, bolečina, žeja
English: • carbamazepine, oxcarbazepine, phenobarbital, phenytoin
Slovenian: • karbamazepin, okskarbazepin, fenobarbital, fenitoin,
English: Bone problems include bone pain, and bone softening or thinning (which may lead to fractures).
Slovenian: Med težavami s kostmi so bolečine v kosteh in zmehčanje ali redčenje kosti (kar lahko povzroči zlome).
English: • joint pain, breakdown of muscle tissue, muscular weakness
Slovenian: • bolečina v sklepih, razgradnja mišičnega tkiva, šibkost mišic
English: To monitor maternal-foetal outcomes in patients exposed to antiretroviral medicinal products while pregnant, an Antiretroviral Pregnancy Registry has been established.
Slovenian: Register uporabe protiretrovirusnih zdravil v nosečnosti Za okužene nosečnice, ki so med nosečnostjo prejemale protiretrovirusna zdravila, je za spremljanje izidov pri materi in plodu na voljo register.
English: No significant cross-resistance has been demonstrated between doravirine-resistant HIV-1 variants and lamivudine/emtricitabine or tenofovir or between lamivudine- or tenofovir-resistant variants and doravirine.
Slovenian: Ugotovili niso nobene pomembne navzkrižne odpornosti med različicami HIV-1, odpornimi proti doravirinu, ter lamivudinom/emtricitabinom ali tenofovirjem, ali med različicami, odpornimi proti lamivudinu ali tenofovirju, ter doravirinom.
English: Lamivudine was mutagenic in an L5178Y mouse lymphoma assay and clastogenic in a cytogenetic assay using cultured human lymphocytes.
Slovenian: Lamivudin je bil mutagen v limfomskem preizkusu L5178Y pri miših in klastogen v citogenetskem preizkusu z uporabo človeških limfocitov v kulturi.
English: When possible, avoid chronic co-administration of doravirine/lamivudine/tenofovir disoproxil with medicinal products containing sorbitol or other osmotic acting polyalcohols (e.g., xylitol, mannitol, lactitol, maltitol).
Slovenian: Če je mogoče, se izognite kronični sočasni uporabi kombinacije doravirin/lamivudin/dizoproksil tenofovirat z zdravili, ki vsebujejo sorbitol ali druge osmotsko delujoče polialkohole (npr. ksilitol, manitol, laktitol, maltitol).
English: In the DRIVE-SHIFT trial, an immediate switch to Delstrigo was demonstrated to be non-inferior at Week 48 compared to continuation of the baseline regimen at Week 24 as assessed by the proportion of subjects with HIV-1 RNA < 40 copies/mL.
Slovenian: Preskušanje DRIVE-SHIFT je pokazalo, da takojšen prehod na zdravilo Delstrigo po 48 tednih ni bil inferioren nadaljevanju izhodiščne sheme po 24 tednih, kar je bilo ocenjeno z deležem preiskovancev s HIV-1 RNA < 40 kopij/ml.
English: • trouble concentrating, memory problems, tingling of hands and feet, stiff muscles, poor quality of sleep
Slovenian: • težave z zbranostjo, težave s spominom, mravljinčenje v dlaneh in stopalih, togost mišic, slaba kakovost spanja
English: Includes subjects who discontinued study drug or study before Week 48 for ISG or before Week 24 for DSG for lack or loss of efficacy and subjects with HIV-1 RNA ≥ 40 copies/mL in the Week 48 window for ISG and in the Week 24 window for DSG.
Slovenian: Vključuje preiskovance, ki so prenehali uporabljati raziskovano zdravilo ali so prenehali sodelovati v študiji pred 48. tednom (skupina ISG) oziroma pred 24. tednom (skupina DSG) zaradi nezadostne učinkovitosti ali izgube učinkovitosti, ter preiskovance, ki so imeli HIV-1 RNA ≥ 40 kopij/ml v oknu 48. tedna (skupina ISG) oziroma oknu 24. tedna (skupina DSG).
English: Antiandrogens enzalutamide
Slovenian: Antiandrogeni enzalutamid
English: It is recommended that estimated CrCl be assessed in all patients prior to initiating therapy and as clinically appropriate during therapy with Delstrigo.
Slovenian: Očistek kreatinina je priporočljivo določiti pri vseh bolnikih pred uvedbo zdravljenja z zdravilom Delstrigo in, če je klinično primerno, med zdravljenjem.
English: A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with tenofovir disoproxil.
Slovenian: Zmeren obseg podatkov pri nosečnicah (med 300 in 1.000 izidov nosečnosti) ne kaže, da bi bil dizoproksiltenofovirat povezan z malformacijami ali toksičnimi učinki pri plodu/novorojenčku.
English: Doravirine is primarily metabolised by CYP3A, and medicinal products that induce or inhibit CYP3A are expected to affect the clearance of doravirine (see section 5.2).
Slovenian: Doravirin se presnovi predvsem s CYP3A, zato je mogoče pričakovati, da zdravila, ki inducirajo ali zavirajo CYP3A, vplivajo na očistek doravirina (glejte poglavje 5.2).
English: • It is important that you do not miss or skip doses of Delstrigo.
Slovenian: • Pomembno je, da odmerkov zdravila Delstrigo ne izpustite in ne preskočite.