FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have hepatitis B infection, liver problems may become worse after you stop taking Genvoya.
Slovenian: Če imate okužbo s hepatitisom B, se lahko težave z jetri poslabšajo, ko prenehate jemati zdravilo Genvoya.
English: 5 This study was conducted using Genvoya.
Slovenian: 5 Ta študija je bila opravljena z zdravilom Genvoya.
English: The adverse reactions in Table 2 are listed by system organ class and frequency.
Slovenian: Neželeni učinki v preglednici 2 so našteti po organskih sistemih in pogostnosti.
English: Medicines used in treating hepatitis B infection:
Slovenian: Zdravila, ki se uporabljajo za zdravljenje okužbe s hepatitisom B:
English: • suicidal thoughts and suicide attempt (in patients who have had depression or mental health problems before), depression
Slovenian: • samomorilne misli in poskus samomora (pri bolnikih, ki so že imeli depresijo ali težave z duševnim zdravjem), depresija
English: Genvoya (n = 959)
Slovenian: (n = 959)
English: Alternative endothelin receptor antagonists may be considered.
Slovenian: Razmisli se lahko o drugih antagonistih receptorjev endotelina.
English: Pooled treatment outcomes at 48 and 144 weeks are shown in Table 3.
Slovenian: Združeni izidi zdravljenja v 48. in 144. tednu so prikazani v preglednici 3.
English: Study GS-US-292-0106
Slovenian: Študija GS-US-292-0106
English: EVG = elvitegravir; COBI = cobicistat; FTC = emtricitabine; TAF = tenofovir alafenamide fumarate; TFV = tenofovir N/A = not applicable
Slovenian: EVG = elvitegravir; COBI = kobicistat; FTC = emtricitabin; TAF = tenofoviralafenamidijev fumarat; TFV = tenofovir n/v = ne velja
English: In clinical studies of Genvoya, increases in serum creatinine occurred by Week 2 of treatment and remained stable through 144 weeks.
Slovenian: V kliničnih študijah z zdravilom Genvoya se je pojavilo zvišanje serumskega kreatinina do 2. tedna zdravljenja in je ostalo stabilno do konca 144. tedna.
English: If you have both HIV infection and hepatitis B, it is especially important not to stop your Genvoya treatment without talking to your doctor first.
Slovenian: Če ste okuženi tako z virusom HIV kot s hepatitisom B, je še zlasti pomembno, da ne prenehate z zdravljenjem z zdravilom Genvoya, ne da bi se prej posvetovali z zdravnikom.
English: Cmin: N/A
Slovenian: Cmin: n/v
English: ANTICOAGULANTS Dabigatran
Slovenian: ANTIKOAGULANTI dabigatran
English: Co-administration with medicinal products that are substrates of P-gp, BCRP, OATP1B1 and OATP1B3 may result in increased plasma concentrations of these products.
Slovenian: Sočasno dajanje z zdravili, ki so substrati P-gp, BCRP, OATP1B1 in OATP1B3 lahko povzroči zvišanje koncentracij teh zdravil v plazmi.
English: The use of Genvoya in children aged 5 years or under has not yet been studied.
Slovenian: Uporabe zdravila Genvoya pri otrocih, starih 5 let ali manj, še niso preučili.
English: Clinical data
Slovenian: KLINIČNI PODATKI
English: The median terminal plasma half-life of elvitegravir following administration of E/C/F/TDF is approximately 12.9 hours.
Slovenian: Mediani končni razpolovni čas elvitegravirja v plazmi po uporabi E/C/F/TDF je približno 12,9 ur.
English: bosentan and tadalafil
Slovenian: bosentan in tadalafil
English: Each tablet contains 61 mg lactose (as monohydrate).
Slovenian: Ena tableta vsebuje 61 mg laktoze (v obliki laktoze monohidrata).
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Slovenian: Bolniki z že obstoječo jetrno disfunkcijo, vključno s kroničnim aktivnim hepatitisom, imajo v času kombinirane protiretrovirusne terapije (CART- combination antiretroviral therapy) več anomalij jetrne funkcije in jih je treba nadzirati v skladu s standardno prakso.
English: Contents of the pack and other information What Genvoya contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Genvoya
English: Disopyramide Flecainide Systemic lidocaine Mexiletine Propafenone
Slovenian: dizopiramid flekainid sistemski lidokain meksiletin propafenon
English: • antacids, used to treat heartburn or acid reflux (see also section 3, How to take Genvoya).
Slovenian: • antacide, ki se uporabljajo za zdravljenje zgage ali refluksa kisline (glejte tudi poglavje 3 Kako jemati zdravilo Genvoya).
English: Genvoya should be taken orally, once daily with food (see section 5.2).
Slovenian: Zdravilo Genvoya se jemlje enkrat dnevno, peroralno s hrano (glejte poglavje 5.2).
English: Pharmacotherapeutic group: Antivirals for systemic use; antivirals for treatment of HIV infections, combinations.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zdravila za zdravljenje infekcij s HIV, kombinacije.
English: Inhibitors of OATP and BCRP include ciclosporin.
Slovenian: Zaviralci OATP in BCRP vključujejo ciklosporin.
English: Adolescents aged 12 to < 18 years, ≥ 35 kg
Slovenian: Mladostniki, stari 12 do < 18 let, ≥ 35 kg
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Slovenian: Pri nekaterih bolnikih z napredovalo okužbo s HIV (AIDSom) in oportunističnimi okužbami v zdravstveni zgodovini (okužbe, ki se pojavijo pri ljudeh z oslabljenim imunskim sistemom), se lahko znaki in simptomi vnetja zaradi prejšnjih okužb pojavijo kmalu po začetku zdravljenja HIV.
English: • neuroleptics/antipsychotics: pimozide, lurasidone
Slovenian: • nevroleptiki/antipsihotiki: pimozid, lurasidon
English: Reduced susceptibility to elvitegravir is most commonly associated with the primary integrase mutations T66I, E92Q, and Q148R.
Slovenian: Zmanjšana občutljivost za elvitegravir je najbolj pogosto povezana s primarnimi mutacijami integraze T66I, E92Q in Q148R.
English: Do not store the split tablet.
Slovenian: Prepolovljenih tablet ne shranjujte.
English: Tenofovir alafenamide and tenofovir have a median plasma half-life of 0.51 and 32.37 hours, respectively.
Slovenian: Tenofoviralafenamid in tenofovir imata mediani razpolovni čas v plazmi 0,51 oz. 32,37 ur.
English: Genvoya contains four active substances:
Slovenian: Zdravilo Genvoya vsebuje štiri učinkovine:
English: At baseline, median eGFR was 56 mL/min.
Slovenian: Na začetku je bila mediana eGFR 56 ml/min.
English: For elvitegravir, Cmax and AUC increased 22% and 36% with a light meal, and 56% and 91% with a high-fat meal, relative to fasting conditions.
Slovenian: Za elvitegravir se je Cmax zvišal za 22 % in AUC za 36 % pri lahkem obroku in pri obroku z visoko vsebnostjo maščobe za 56 % oz. 91 % relativno glede na pogoje na tešče.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Genvoya in one or more subsets of the paediatric population in the treatment of human HIV-1 infection (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Genvoya za eno ali več podskupin pediatrične populacije za zdravljenje okužbe z virusom HIV-1 pri ljudeh (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • If you are allergic to elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Slovenian: • Če ste alergični na elvitegravir, kobicistat, emtricitabin, tenofoviralafenamid ali katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
English: EU/1/15/1061/001 30 film-coated tablets EU/1/15/1061/002 90 (3 bottles of 30) film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/15/1061/001 30 filmsko obloženih tablet EU/1/15/1061/002 90 (3 plastenke po 30) filmsko obloženih tablet
English: One patient in the Genvoya group (1 of 22 [4.5%]) and 2 patients in the E/C/F/TDF group (2 of 20 [10%]) had reduced susceptibility to tenofovir.
Slovenian: En bolnik v skupini z zdravilom Genvoya (1 od 22 [4,5 %]) in 2 bolnika v skupini E/C/F/TDF (2 od 20 [10 %]) sta imela zmanjšano občutljivost za tenofovir.
English: digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine and verapamil
Slovenian: digoksin, dizopiramid, flekainid, lidokain, meksiletin, propafenon, metoprolol, timolol, amlodipin, diltiazem, felodipin, nikardipin, nifedipin in verapamil
English: Elvitegravir was negative in an in vitro bacterial mutagenicity test (Ames test) and negative in an in vivo rat micronucleus assay at doses up to 2,000 mg/kg.
Slovenian: Elvitegravir je bil negativen v bakterijskem testu mutagenosti in vitro (Amesov test) in negativen v testu podganjih mikronukleusov in vivo pri odmerkih do 2.000 mg/kg.
English: • If you are intolerant to lactose (see Genvoya contains lactose later in this section).
Slovenian: • Če ne prenašate laktoze (glejte odstavek Zdravilo Genvoya vsebuje laktozo v tem poglavju).
English: Viruses expressing the T66I/A mutations maintain susceptibility to raltegravir, while most other patterns showed reduced susceptibility to raltegravir.
Slovenian: Virusi, ki izražajo mutacije T66I/A, ostanejo občutljivi na raltegravir, medtem ko je večina drugih vzorcev pokazala zmanjšano občutljivost za raltegravir.
English: Additional integrase mutations observed in cell culture selection included H51Y, F121Y, S147G, S153Y, E157Q, and R263K.
Slovenian: Dodatne mutacije integraze, ki so jih opazili v izboru celične kulture, so vključevale H51Y, F121Y, S147G, S153Y, E157Q in R263K.
English: Cobicistat is an inhibitor of the following transporters: P-gp, breast cancer resistance protein (BCRP), organic anion transporting polypeptide (OATP) 1B1 and OATP1B3.
Slovenian: Kobicistat je zaviralec naslednjih prenašalcev: P-gp, proteina rezistence pri raku dojke (BCRP- breast cancer resistance protein), transportnega polipeptida organskih anionov (OATP- organic anion transporting polypeptide), 1B1 in OATP1B3.
English: In an in vitro chromosomal aberration test, elvitegravir was negative with metabolic activation; however, an equivocal response was observed without activation.
Slovenian: V testu kromosomske aberacije in vitro je bil elvitegravir negativen z aktivacijo presnove, vendar pa so brez aktivacije opazili dvoumen odziv.
English: At baseline, 80 patients (33%) had eGFRCG < 50 mL/min and 162 patients had eGFRCG ≥ 50 mL/min.
Slovenian: Na začetku je imelo 80 bolnikov (33 %) eGFRCG < 50 ml/min in 162 bolnikov je imelo eGFRCG ≥ 50 ml/min.
English: As elvitegravir and cobicistat are highly bound to plasma proteins, it is unlikely that they would be significantly removed by haemodialysis or peritoneal dialysis.
Slovenian: Ker se elvitegravir in kobicistat močno vežeta na plazemske proteine, ni verjetno, da bi ju hemodializa ali peritonealna dializa odstranila v pomembni meri.
English: Some patients taking combination antiretroviral medicines such as Genvoya may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Slovenian: Pri nekaterih bolnikih, ki jemljejo kombinirana protiretrovirusna zdravila, kot je zdravilo Genvoya, se lahko pojavi bolezen kosti, imenovana osteonekroza (odmiranje kostnega tkiva kot posledica pomanjkanja oskrbe kosti s krvjo).
English: Most HIV-1 isolates from patients in both treatment groups who developed resistance mutations to elvitegravir developed resistance mutations to both emtricitabine and elvitegravir.
Slovenian: Pri večini izolatov HIV-1 bolnikov v obeh skupinah zdravljenja, pri katerih so se razvile mutacije, povezane z rezistenco na elvitegravir, so se razvile mutacije, povezane z rezistenco tako za emtricitabin kot elvitegravir.
English: The mean plasma to blood drug concentration ratio was 1.37.
Slovenian: Povprečno razmerje med koncentracijo zdravila v plazmi in krvi je bilo 1,37.
English: As the effect of cationic complexation of elvitegravir cannot be excluded when Genvoya is co-administered with multivitamin supplements, it is recommended to separate Genvoya and multivitamin supplements dosing by at least 4 hours.
Slovenian: Ker učinkov kationske kompleksacije elvitegravira pri sočasni uporabi zdravila Genvoya ni mogoče izključiti, se priporoča, da se dajanje zdravila Genvoya in multivitaminskih dopolnil loči za vsaj 4 ure.
English: If you vomit less than 1 hour after taking Genvoya, take another tablet with food.
Slovenian: Če bruhate manj kot 1 uro po zaužitju zdravila Genvoya, vzemite še eno tableto s hrano.
English: However, based on the information retrieved in literature and in the product information of integrase inhibitors containing medicinal products, it could be concluded that the following psychiatric disorders: depression, suicidal ideation and suicidal behaviour (particularly in patients with pre-existing history of psychiatric illness) are class-effect of integrase inhibitors and these are listed in the SmPC of other medicinal products containing integrase inhibitors in monotherapy and in fixed-dose combination (FDC).
Slovenian: Vendar pa na podlagi informacij, pridobljenih v literaturi in v informacijah o zdravilih, ki vsebujejo zaviralce integraze, lahko sklepamo, da so naslednje psihiatrične motnje: depresija, samomorilne misli in samomorilno vedenje (zlasti pri bolnikih s predhodno anamnezo psihiatrične bolezni) učinek zdravil iz skupine zaviralcev integraze, in so navedene v povzetku glavnih značilnosti zdravila za druga zdravila, ki vsebujejo zaviralce integraze v obliki monoterapije in v obliki kombinacije fiksnih odmerkov (FDC).
English: Patients co-infected with HIV and HBV who discontinue Genvoya should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Slovenian: Bolnike s hkratno okužbo s HIV in HBV, ki prekinejo zdravljenje z zdravilom Genvoya, je potrebno pozorneje opazovati in opravljati potrebne klinične in laboratorijske preiskave še vsaj nekaj mesecev po prenehanju zdravljenja.
English: Elvitegravir, cobicistat, and emtricitabine have all demonstrated low carcinogenic potential in mice and rats.
Slovenian: Elvitegravir, kobicistat in emtricitabin so pokazali majhen kancerogeni potencial pri miših in podganah.
English: If you are on dialysis, take your daily dose of Genvoya following completion of dialysis.
Slovenian: Če ste na dializi, vzemite svoj dnevni odmerek zdravila Genvoya po končani dializi.
English: If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
Slovenian: Kadar ni mogoče uporabiti drugih zdravil, se lahko uporabljajo le po zdravniškem pregledu in ob natančnem zdravniškem spremljanju zaradi možnosti pojava neželenih učinkov, povezanih s kortikosteroidi.
English: abnormal dreams
Slovenian: nenavadne sanje
English: Interactions between the components of Genvoya and potential co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Slovenian: Interakcije med učinkovinami zdravila Genvoya in možnimi sočasno uporabljenimi zdravili so navedene v preglednici 1 spodaj (povečanje je označeno z znakom “↑”, zmanjšanje z “↓”, brez spremembe z “↔”).
English: An assessment of benefit/risk ratio is recommended to justify use of voriconazole with Genvoya.
Slovenian: Priporoča se ocena razmerja med koristmi in tveganji, ki bi upravičila uporabo vorikonazola z zdravilom Genvoya.
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (~9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (~4% of dose).
Slovenian: Biotransformacija emtricitabina vključuje oksidacijo tiolnega dela molekule, pri čemer nastanejo 3'-sulfoksid diastereomere (~9 % odmerka) in konjugacijo z glukuronsko kislino, pri čemer nastane 2'-O-glukuronid (~4 % odmerka).
English: Once you start taking Genvoya, look out for:
Slovenian: Ko začnete jemati zdravilo Genvoya, bodite pozorni na:
English: A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).
Slovenian: Morebitnega tveganja nefrotoksičnosti kot posledice kronične izpostavljenosti nizkim ravnem tenofovirja zaradi odmerjanja tenofoviralafenamida ni mogoče izključiti (glejte poglavje 5.3).
English: The pharmacokinetics of emtricitabine have not been studied in patients with hepatic impairment; however, emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Slovenian: Farmakokinetičnih lastnosti emtricitabina pri bolnikih z jetrno okvaro niso proučevali, vendar jetrni encimi emtricitabina ne presnavljajo v pomembnem obsegu, zato je vpliv jetrne okvare verjetno omejen.
English: Genvoya is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:
Slovenian: Zdravilo Genvoya je indicirano za zdravljenje virusa humane imunske pomanjkljivosti tipa 1 (HIV-1) brez kakršnih koli znanih mutacij, povezanih z rezistenco proti skupini zaviralcev integraze, emtricitabinu ali tenofovirju, kot sledi:
English: Table 7: Changes in pharmacokinetic parameters from the IMPAACT P1026s study for elvitegravir and cobicistat in women receiving cobicistat and elvitegravir-containing regimens during the second and third trimesters of pregnancy compared to paired postpartum data
Slovenian: Preglednica 7: Spremembe farmakokinetičnih parametrov iz študije IMPAACT P1026s za elvitegravir in kobicistat pri ženskah, ki so prejemale režime s kobicistatom in elvitegravirjem v drugem in tretjem trimestru nosečnosti, v primerjavi z sparjenimi podatki iz poporodnega obdobja
English: Integrase is an HIV-1 encoded enzyme that is required for viral replication.
Slovenian: Integraza je kodiran encim HIV-1, potreben za razmnoževanje virusa.
English: Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Slovenian: Ustrezni primeri vključujejo citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in s Pneumocystis jirovecii povzročeno pljučnico.
English: If you have difficulty swallowing the tablet whole, you can split it in half.
Slovenian: Če tablete ne morete pogoltniti cele, jo lahko prepolovite.
English: Talk to your doctor if you are taking:
Slovenian: Druge vrste zdravil: Obvestite svojega zdravnika, če jemljete:
English: ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan
Slovenian: ANTAGONISTI RECEPTORJEV ENDOTELINA bosentan
English: INHALED BETA AGONIST Salmeterol
Slovenian: INHALIRANI AGONISTI BETA salmeterol
English: Limited data from population pharmacokinetic analysis (n = 24) indicated that hepatitis B and/or C virus infection had no clinically relevant effect on the exposure of boosted elvitegravir.
Slovenian: Omejeni podatki populacijske farmakokinetične analize (n = 24) so pokazali, da sočasna okužba z virusom hepatitisa B in/ali C nima klinično pomembnega učinka na izpostavljenost okrepljenemu elvitegravirju.
English: These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown aetiology, particularly neurologic findings.
Slovenian: Te ugotovitve je treba upoštevati pri vseh otrocih, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom, pri katerih se pojavijo resne klinične ugotovitve neznanega vzroka, še zlasti nevrološke.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
Slovenian: V primeru prevelikega odmerka je potrebno pri bolniku nadzorovati znake toksičnosti (glejte poglavje 4.8).
English: Contains lactose, see leaflet for further information.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje laktozo, za dodatne informacije glejte navodilo za uporabo.
English: Elvitegravir plasma concentrations are lower with antacids due to local complexation in the gastrointestinal tract and not to changes in gastric pH.
Slovenian: Koncentracije elvitegravirja v plazmi so z antacidi nižje zaradi lokalne kompleksacije v prebavilih in ne zaradi sprememb vrednosti pH
English: Elvitegravir, emtricitabine, and tenofovir alafenamide demonstrated synergistic antiviral activity in cell culture.
Slovenian: Elvitegravir, emtricitabin in tenofoviralafenamid so pokazali sinergijsko protivirusno aktivnost v celični kulturi.
English: Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to desacetyl-rifabutin.
Slovenian: Potrebno je povečano spremljanje neželenih učinkov, povezanih rifabutinom, vključno z nevtropenijo in uveitisom, zaradi pričakovane večje izpostavljenosti desacetil-rifabutinu.
English: There were no clinically significant changes in fasting lipid laboratory tests in patients who switched to Genvoya.
Slovenian: Klinično pomembnih sprememb v laboratorijskih preiskavah lipidov na tešče pri bolnikih, ki so prešli na zdravilo Genvoya, ni bilo.
English: The safety and efficacy of Genvoya in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Slovenian: Varnost in učinkovitost zdravila Genvoya pri bolnikih s hkratno okužbo s HIV-1 in hepatitisa C (HCV) nista bili dokazani.
English: Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Slovenian: Po peroralni uporabi zdravila je razpolovni čas izločanja emtricitabina približno 10 ur.
English: Genvoya comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets).
Slovenian: Zdravilo Genvoya je na voljo v plastenkah po 30 tablet (s silikagelskim sušilnim sredstvom, ki mora ostati v vsebniku zaradi zaščite tablet).
English: Tenofovir alafenamide is transported by P-gp and BCRP.
Slovenian: Tenofoviralafenamid se prenaša s P-gp in BCRP.
English: However increased post-implantation loss and decreased foetal weights were observed in rats associated with significant decreases in maternal body weights at 125 mg/kg/day.
Slovenian: Vendar pa so pri podganah opazili večjo izgubo po ugnezditvi in manjšo telesno maso plodov, povezano z značilnimi zmanjšanji materine telesne mase s 125 mg/kg/dan.
English: Do not take antacids or multivitamins at the same time as Genvoya.
Slovenian: Antacidov ali multivitaminskih dopolnil ne jemljite hkrati z zdravilom Genvoya.
English: • antidepressants, used to treat depression: medicines containing trazodone or escitalopram
Slovenian: • antidepresive, ki se uporabljajo za zdravljenje depresije: zdravila, ki vsebujejo trazodon ali escitalopram
English: Therefore, information regarding drug-drug interactions with other antiretroviral products (including protease inhibitors [PIs] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) is not provided (see section 4.4).
Slovenian: Zato informacije o medsebojnem delovanju z drugimi protiretrovirusnimi zdravili (vključno s PI in nenukleozidnimi zaviralci reverzne transkriptaze [NNRTI- non-nucleoside reverse transcriptase inhibitors]) niso navedene (glejte poglavje 4.4).
English: Comparison to paired postpartum data, n
Slovenian: Primerjava s sparjenimi poporodnimi podatki, n
English: In clinical trials, the incidence of SAEs related to suicide for Genvoya was 0.6% (26/4137 subjects), therefore, the frequency proposed is “uncommon”.
Slovenian: V kliničnih preskušanjih je bila pojavnost resnih neželenih dogodkov v povezavi s samomorom za zdravilo Genvoya 0,6 % (26/4137 oseb), zato je predlagana pogostnost »občasna«.