FrancophonIA/ELRC3.0 huggingface dataset:
English: In 13 treatment-naïve subjects on a stable dolutegravir plus abacavir/lamivudine regimen, dolutegravir concentration in CSF averaged 18 ng/mL (comparable to unbound plasma concentration, and above the IC50).
Slovenian: Pri 13 predhodno še nezdravljenih preiskovancih, ki so prejemali stabilno shemo dolutegravirja in abakavirja/lamivudina, je bila povprečna koncentracija dolutegravirja v cerebrospinalni tekočini 18 ng/ml (to je primerljivo s koncentracijo nevezane učinkovine v plazmi ter presega IC50).
English: No specific symptoms or signs have been identified following acute overdose with dolutegravir or rilpivirine apart from those listed as adverse reactions.
Slovenian: Po akutnem prevelikem odmerjanju dolutegravirja ali rilpivirina niso ugotovili dodatnih specifičnih simptomov ali znakov razen tistih, ki so že navedeni kot neželeni učinki.
English: • dry mouth.
Slovenian: • suha usta.
English: Each bottle contains 30 film-coated tablets and a desiccant to reduce moisture.
Slovenian: Ena plastenka vsebuje 30 filmsko obloženih tablet in sušilo za zmanjšanje vlage.
English: Based on the lack of effect on the in vivo pharmacokinetics of the OAT substrate tenofovir, in vivo inhibition of OAT1 is unlikely.
Slovenian: Ker in vivo niso opazili učinka dolutegravirja na farmakokinetiko substrata OAT tenofovirja, zavrtje OAT1 in vivo ni verjetno.
English: In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the CYP3A system.
Slovenian: Poskusi in vitro kažejo, da se rilpivirin presnovi predvsem z oksidativno presnovo preko sistema CYP3A.
English: Each pack of 30 film-coated tablets contains a desiccant.
Slovenian: Vsako pakiranje s 30 filmsko obloženimi tabletami vsebuje sušilo.
English: Neither Juluca nor the combination dolutegravir and rilpivirine as single entities have been studied in children.
Slovenian: Ne zdravilo Juluca ne kombinacija dolutegravirja in rilpivirina kot posameznih učinkovin pri otrocih nista raziskana.
English: CAR = current antiretroviral regimen; DTG+RPV = dolutegravir plus rilpivirine; INI = Integrase inhibitor; NNRTI = Non-nucleoside reverse transcriptase inhibitor; PI = Protease Inhibitor
Slovenian: N = število preiskovancev v posamezni terapevtski skupini CAR = trenutna protiretrovirusna shema, DTG + RPV = dolutegravir + rilpivirin, INI = zaviralec integraze, NNRTI = nenukleozidni zaviralec reverzne transkriptaze, PI = zaviralec proteaze
English: Where possible, alternatives such as azithromycin should be considered.
Slovenian: Če je mogoče, je treba razmisliti o alternativah,
English: The exposure to dolutegravir was decreased by approximately 40% in subjects with severe renal impairment.
Slovenian: Pri preiskovancih s hudo okvaro ledvic je bila izpostavljenost dolutegravirju za približno 40 % manjša.
English: Rilpivirine ↔ AUC ↔ Cmin ↑ 25%
Slovenian: rilpivirin ↔ AUC ↔ Cmin ↑ 25 %
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.56 times the 50 mg human clinical exposure based on AUC).
Slovenian: Pri kuncih so toksične učinke pri samicah materah (manjše uživanje hrane, majhno izločanje/brez izločanja blata oz. urina, zavrto pridobivanje telesne mase) opažali pri 1000 mg/kg (0,56-kratnik klinične izpostavljenosti pri človeku med uporabo 50 mg na podlagi AUC).
English: Tabulated summary of adverse reactions to Juluca based on clinical study and postmarketing experience with Juluca and its individual components
Slovenian: Preglednica 2: Povzetek neželenih učinkov zdravila Juluca na podlagi izkušenj z zdravilom Juluca in njegovima posameznima učinkovinama v kliničnih študijah in obdobju po prihodu zdravila na trg.
English: • medicines called antacids, to treat indigestion and heartburn.
Slovenian: • zdravila, imenovana antacidi, za zdravljenje težav z želodcem in zgage.
English: Antacids and supplements Antacids (e.g., aluminium magnesium hydroxide, and/or calcium carbonate)/
Slovenian: Antacidi in dodatki antacidi (npr. aluminijev magnezijev hidroksid in/ali kalcijev karbonat)/ dolutegravir1
English: Of the 29 subjects that completed the study, 27 subjects were suppressed at the end of the study.
Slovenian: Od 29 bolnic, ki so dokončale študijo, jih je imelo virološko supresijo 27.
English: Juluca has not been studied in patients on dialysis.
Slovenian: Zdravilo Juluca ni raziskano pri bolnikih na dializi.
English: Rilpivirine inhibits P-gp in vitro (IC50 is 9.2 μM).
Slovenian: In vitro rilpivirin zavira P-gp (IC50 9,2 µM).
English: Seven hundred and five raltegravir resistant isolates from raltegravir experienced patients were analysed for susceptibility to dolutegravir.
Slovenian: Glede občutljivosti za dolutegravir so analizirali 705 izolatov, odpornih proti raltegravirju, dobljenih od bolnikov, ki so že prejemali raltegravir.
English: A single dose of 50 mg of dolutegravir was administered to 8 subjects with moderate hepatic impairment (Child-Pugh score B) and to 8 matched healthy adult controls.
Slovenian: Enkraten odmerek 50 mg dolutegravirja so uporabili pri 8 preiskovancih z zmerno okvaro jeter (Child-Pugh B) in pri 8 ujemajočih se zdravih odraslih kontrolnih preiskovancih.
English: Population pharmacokinetic analyses from studies with the individual components revealed that gender had no clinically relevant effect on the pharmacokinetics of dolutegravir or rilpivirine.
Slovenian: Populacijske farmakokinetične analize študij s posameznima učinkovinama so pokazale, da spol nima klinično pomembnega vpliva na farmakokinetiko dolutegravirja ali rilpivirina.
English: There are limited data from the use of dolutegravir or rilpivirine in pregnant women.
Slovenian: Podatkov o uporabi dolutegravirja ali rilpivirina pri nosečnicah je malo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1282/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1282/001
English: From the week 48 to the week 96 analysis, 24 (3.5%) and 14 (2.1%) additional virologic failures occurred in the rilpivirine and efavirenz arm, respectively.
Slovenian: V analizi podatkov od 48. do 96. tedna se je virološki neuspeh dodatno pojavil pri 24 (3,5 %) bolnikih v skupini z rilpivirinom in pri 14 (2,1 %) bolnikih v skupini z efavirenzom.
English: The exposures at the embryo-foetal No Observed Adverse Effects Levels (NOAELs) in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended dose of 25 mg once daily.
Slovenian: Izpostavljenost brez opaženih neželenih učinkov (NOAEL - no observed adverse effects levels) na zarodek ali plod so bile pri podganah 15-krat, pri kuncih pa 70-krat večje od izpostavljenosti pri človeku med uporabo priporočenega odmerka 25 mg enkrat na dan.
English: Nervous system disorders very common headache dizziness common somnolence
Slovenian: Bolezni živčevja zelo pogosti glavobol omotica pogosti zaspanost
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite neželene katere koli učinke, ki niso navedeni v tem navodilu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1282/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1282/002
English: Population pharmacokinetic analysis indicated that hepatitis C virus co-infection had no clinically relevant effect on the exposure to dolutegravir or rilpivirine.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da sočasna okužba z virusom hepatitisa C nima klinično pomembnega vpliva na izpostavljenost dolutegravirju ali rilpivirinu.
English: In vitro, dolutegravir inhibited the renal uptake transporters, organic anion transporters (OAT)1 and OAT3.
Slovenian: In vitro je dolutegravir zaviral ledvična prenašalca privzema, prenašalca organskih anionov OAT1 in OAT3.
English: While the total dolutegravir concentration in plasma was similar, a 1.5- to 2-fold increase in unbound exposure to dolutegravir was observed in subjects with moderate hepatic impairment compared to healthy controls.
Slovenian: Celotna koncentracija dolutegravirja v plazmi je bila sicer podobna, vendar so pri preiskovancih z zmerno okvaro jeter v primerjavi z zdravimi kontrolnimi preiskovanci ugotovili od 1,5- do 2-kratno povečanje izpostavljenosti nevezanemu dolutegravirju.
English: Calcium supplements, iron supplements or multivitamins Calcium supplements, iron supplements or multivitamins can stop Juluca being absorbed into your body and make it less effective.
Slovenian: Dodatki kalcija, dodatki železa ali multivitaminski pripravki lahko preprečijo absorpcijo zdravila Juluca v telo in zmanjšajo njegovo učinkovitost.
English: There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults.
Slovenian: Ugotovili niso nobenih novih izsledkov o varnosti v primerjavi z znanimi varnostnimi značilnostmi rilpivirina pri odraslih,
English: Dolutegravir or rilpivirine did not change ethinyl estradiol and norelgestromin (dolutegravir) or norethindrone (rilpivirine) plasma concentrations to a clinically relevant extent.
Slovenian: Dolutegravir oz. rilpivirin nista klinično pomembno spremenila koncentracije etinilestradiola in norelgestromina (dolutegravir)
English: In patients with severe renal impairment or end stage renal disease, the combination of Juluca with a strong CYP3A inhibitor should only be used if the benefit outweighs the risk.
Slovenian: Pri bolnikih s hudo okvaro ledvic ali končno odpovedjo ledvic se sme zdravilo Juluca v kombinaciji z močnim zaviralcem CYP3A uporabiti le, če je korist večja od tveganja.
English: The combination of Juluca and H2-receptor antagonists should be used with particular caution.
Slovenian: Kombinacijo zdravila Juluca in antagonistov receptorjev H2 je treba uporabljati posebej previdno.
English: The between-subject PK variability of dolutegravir was higher in HIV-infected subjects than healthy subjects.
Slovenian: Interindividualna farmakokinetična variabilnost dolutegravirja je bila pri preiskovancih, okuženih s HIV, večja kot pri zdravih.
English: In Phase I studies in healthy subjects, between-subject CVb% for AUC and Cmax ranged from ~20 to 40% and Cτ from 30 to 65% across studies.
Slovenian: V študijah faze I pri zdravih preiskovancih je interindividualni KVb% za AUC in Cmax med študijami obsegal od ~20 do 40 % in
English: In vitro, dolutegravir demonstrated no direct, or weak inhibition (IC50>50 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 CYP3A, uridine diphosphate glucuronosyl transferase (UGT)1A1 or UGT2B7, or the transporters Pgp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 or MRP4.
Slovenian: In vitro dolutegravir ni pokazal neposrednega ali šibkega zaviralnega učinka (IC50 > 50 µM) na encime citokroma P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6
English: Azole anti-fungals Ketoconazole/ Dolutegravir Ketoconazole/ Rilpivirine1,2
Slovenian: Azolni antimikotiki ketokonazol/ dolutegravir ketokonazol/ rilpivirin1,2
English: NAME OF THE MEDICINAL PRODUCT Juluca 50 mg/25 mg film-coated tablets
Slovenian: IME ZDRAVILA Juluca 50 mg/25 mg filmsko obložene tablete
English: Population pharmacokinetic analysis using data in HIV-1 infected adults showed that there was no clinically relevant effect of age on dolutegravir or rilpivirine exposures.
Slovenian: Populacijska farmakokinetična analiza podatkov s HIV-1 okuženih odraslih ni pokazala klinično pomembnega vpliva starosti na izpostavljenost dolutegravirju ali rilpivirinu.
English: In patients with severe renal impairment or end-stage renal disease, the combination of Juluca with a strong CYP3A inhibitor should only be used if the benefit outweighs the risk.
Slovenian: Pri bolnikih s hudo okvaro ledvic ali s končno odpovedjo ledvic se sme kombinacijo zdravila Juluca in močnega zaviralca CYP3A uporabiti samo, če je korist večja od tveganja.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Slovenian: HIV na druge, čeprav učinkovito protiretrovirusno zdravljenje to tveganje zmanjša.
English: In serial passage with strain NL432-based site directed mutants at N155H or E92Q, no further selection of resistance was seen (FC unchanged around 1).
Slovenian: ali E92Q na osnovi seva NL432 niso opazili nadaljnje selekcije odpornosti (FC nespremenjen okoli 1).
English: As a number of different medicines can cause this condition, you should ask your doctor or pharmacist if you are not sure
Slovenian: To motnjo lahko povzročijo številna različna zdravila; če ste negotovi, se posvetujte z zdravnikom ali farmacevtom,
English: Uncommon side effects These may affect up to 1 in 100 people:
Slovenian: Občasni neželeni učinki Pojavijo se lahko pri največ 1 od 100 bolnikov:
English: 2 years.
Slovenian: tednov).
English: Juluca must be taken with a meal to obtain optimal absorption of rilpivirine (see section 4.2).
Slovenian: Za optimalno absorpcijo rilpivirina je treba zdravilo Juluca jemati z obrokom (glejte poglavje 4.2).
English: The most commonly observed amino acid substitutions that emerged included: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Slovenian: Med najpogosteje opaženimi substitucijami aminokislin, ki so se pojavile, so bile: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C
English: If you vomit less than 4 hours after taking Juluca, take another tablet with a meal.
Slovenian: Če bruhate prej kot 4 ure po zaužitju zdravila Juluca, vzemite še eno tableto s hrano.
English: Dolutegravir ↔ (Not studied)
Slovenian: dolutegravir ↔ (Ni raziskano)
English: • palpitations (rapid or irregular heartbeat) or tremor
Slovenian: Med simptomi so lahko: • palpitacije (hitro ali neredno bitje srca) ali tresenje (tremor),
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (induction of UGT1A1 and CYP3A enzymes).
Slovenian: dolutegravir ↓ AUC ↓ 54 % Cmax ↓ 43 % Cτ ↓72 % (indukcija encimov UGT1A1 in CYP3A).
English: How to take Juluca
Slovenian: Kako jemati zdravilo Juluca
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to CART.
Slovenian: uživanjem alkohola, hudo imunosupresijo in višjim indeksom telesne mase), so o primerih osteonekroze poročali predvsem pri bolnikih z napredovalo boleznijo HIV in/ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART).
English: • weakness beginning in the hands and feet and moving up towards the trunk of the body.
Slovenian: • hiperaktivnost (povečan nemir in prekomerno gibanje), • šibkost, ki se začne v dlaneh in stopalih in se širi navzgor proti trupu.
English: A higher incidence of liver chemistry elevations (Grade 1) were observed in patients treated with dolutegravir and rilpivirine co-infected with hepatitis C compared to those who were not co-infected.
Slovenian: Med zdravljenjem z dolutegravirjem in rilpivirinom so opažali večjo pojavnost zvišanj jetrnih laboratorijskih vrednosti (1. stopnje) pri bolnikih, ki so bili sočasno okuženi s hepatitisom C, kot pri bolnikih, ki niso bili sočasno okuženi.
English: Of the 12 subjects that completed the study, 10 subjects were suppressed at the end of the study; in the other 2 subjects an increase in viral load was observed postpartum, for 1 subject due to suspected suboptimal adherence.
Slovenian: Pri preostalih 2 so porast virusnega bremena ugotovili po porodu; pri eni od njiju je bil porast posledica domnevno suboptimalne adherence.
English: People taking combination therapy for HIV may get other side effects.
Slovenian: Bolnikom, ki prejemajo kombinirano zdravljenje okužbe z virusom HIV, se lahko pojavijo še drugi neželeni učinki.
English: In patients with severe renal impairment or end-stage renal disease, Juluca should be used with caution, as rilpivirine plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
Slovenian: Juluca uporabljati previdno, kajti koncentracija rilpivirina v plazmi se lahko poveča zaradi spremenjene absorpcije, porazdelitve in/ali presnove zdravila zaradi motenega delovanja ledvic.
English: If you can't take these supplements at the same time as Juluca, do not take a calcium supplements, iron supplements or multivitamins during the 6 hours before you take Juluca, or for at least 4 hours after you take it.
Slovenian: Če teh dodatkov ne morete vzeti hkrati z zdravilom Juluca, ne jemljite dodatkov kalcija, dodatkov železa ali multivitaminskih pripravkov vsaj 6 ur preden vzamete zdravilo Juluca ali še vsaj 4 ure po tem, ko vzamete to zdravilo.
English: These medicinal products are recommended to be administered 6 hours before or 4 hours after Juluca (see section 4.5).
Slovenian: Ta zdravila je priporočljivo vzeti 6 ur pred zdravilom Juluca ali 4 ure po njem (glejte poglavje 4.5).
English: AUC ↓ 9% Cmin NA
Slovenian: AUC ↓ 9 % Cmin NP
English: In patients with prior failed therapies, but naïve to the integrase class (SAILING study), integrase inhibitor substitutions were observed in 4/354 patients (follow-up 48 weeks) treated with dolutegravir, which was given in combination with an investigator selected background regimen (BR).
Slovenian: Pri bolnikih s predhodno neuspešnimi zdravljenji, ki še niso prejemali zaviralcev integraze (študija SAILING), so substitucije z zaviralci integraze opazili pri 4/354 bolnikov (spremljanje 48 tednov),
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.56 times the 50 mg human clinical exposure based on AUC).
Slovenian: Peroralna uporaba dolutegravirja pri brejih kunkah v odmerkih do 1000 mg/kg na dan od 6. do 18. dne gestacije ni povzročila toksičnih učinkov na razvoj ali teratogenih učinkov (0,56-kratnik klinične izpostavljenosti pri človeku med uporabo 50 mg na podlagi AUC).
English: The pooled primary analysis demonstrated that dolutegravir plus rilpivirine is non-inferior to CAR, with 95% of subjects in both arms achieving the primary endpoint of <50 copies/mL plasma HIV-1 RNA at Week 48 based on the Snapshot algorithm (Table 3).
Slovenian: Združena primarna analiza je pokazala, da je kombinacija dolutegravirja in rilpivirina neinferiorna trenutni protiretrovirusni shemi, saj je po 48 tednih primarni opazovani dogodek < 50 kopij/ml HIV-1 RNA v plazmi (z algoritmom Snapshot) doseglo 95 % preiskovancev v obeh terapevtskih skupinah (preglednica 3).
English: Rilpivirine ↔ AUC ↔
Slovenian: rilpivirin ↔ AUC ↔
English: Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Slovenian: In vitro rilpivirin zavira prenašalec MATE-2K z IC50 < 2,7 nM.
English: Juluca is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and rilpivirine.
Slovenian: Zdravilo Juluca vsebuje dve zdravilni učinkovini (dolutegravir in rilpivirin) in je namenjeno za zdravljenje okužbe z virusom humane imunske pomanjkljivosti (HIV).
English: HIV-1 RNA <50 copies/mL Treatment Difference* Virologic non response** Reasons Data in window not <50 copies/mL Discontinued for lack of efficacy Discontinued for other reasons while not <50 copies/mL Change in ART No virologic data at Week 48 window Reasons Discontinued study/study drug due to adverse event or death Discontinued study/study drug for other reasons Missing data during window but on study HIV-1 RNA <50 copies/mL by baseline covariates n/N (%)
Slovenian: Prekinjeno zaradi drugih razlogov ob tem ko vrednost ni bila < 50 kopij/ml Sprememba protiretrovirusnega zdravljenja Ni viroloških podatkov v oknu 48. tedna Razlogi Sodelovanje v študiji/prejemanje preskušanega zdravila prekinjeno zaradi neželenega dogodka ali smrti Sodelovanje v študiji/prejemanje preskušanega zdravila prekinjeno zaradi drugih razlogov
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, cytochrome P450 (CYP)3A4, Pglycoprotein (P-gp), and breast cancer resistance protein (BCRP); therefore medicinal products that induce those enzymes may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 1).
Slovenian: Je tudi substrat UGT1A3, UGT1A9, citokroma P450 (CYP)3A4, P-glikoproteina (P-gp) in proteina odpornosti raka dojke (BCRP).
English: PI
Slovenian: V
English: Dolutegravir is primarily metabolized through glucuronidation via UGT1A1 with a minor CYP3A component.
Slovenian: Biotransformacija Dolutegravir se presnavlja predvsem z glukuronidacijo z UGT1A1 in v majhni meri s CYP3A.
English: SWORD-1 and SWORD-2 Pooled Data*** DTG + RPV N=513 n (%)
Slovenian: DTG + RPV N = 513 n (%)
English: Juluca 50 mg/25 mg film-coated tablets dolutegravir/rilpivirine
Slovenian: Juluca 50 mg/25 mg filmsko obložene tablete dolutegravir/rilpivirin
English: The pharmacokinetics of rilpivirine in 36 antiretroviral treatment-naïve HIV-1 infected adolescent subjects (12 to <18 years of age) receiving rilpivirine 25 mg once daily were comparable to those in treatment-naïve HIV-1 infected adults receiving rilpivirine 25 mg once daily.
Slovenian: Pri 36 s HIV-1 okuženih, predhodno še nezdravljenih mladostnikih (starih od 12 do < 18 let), ki so prejemali 25 mg rilpivirina enkrat na dan, je bila farmakokinetika rilpivirina primerljiva kot pri odraslih, okuženih s HIV-1, ki predhodno še niso bili zdravljeni in so prejemali 25 mg rilpivirina enkrat na dan.
English: The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to <18 years of age and weighing ≥40 kg) showed that dolutegravir 50 mg once daily oral dosage resulted in dolutegravir exposure comparable to that observed in adults who received dolutegravir 50 mg orally once daily.
Slovenian: Farmakokinetika dolutegravirja pri 10 mladostnikih (starih od 12 do < 18 let, ki tehtajo ≥40 kg), ki so bili okuženi s HIV-1 in so predhodno že prejemali protiretrovirusno zdravljenje, je pokazala, da peroralna uporaba 50 mg dolutegravirja enkrat na dan doseže izpostavljenost dolutegravirju, ki je primerljiva izpostavljenosti odraslih med jemanjem 50 mg dolutegravirja peroralno enkrat na dan.
English: → Talk to your doctor for further advice on taking these medicines with Juluca.
Slovenian: → Z zdravnikom se posvetujte o dodatnih navodilih glede jemanja teh zdravil skupaj z zdravilom Juluca.
English: Daclatasvir ↔
Slovenian: daklatasvir ↔
English: Separate preparations of dolutegravir or rilpivirine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated (see section 4.5).
Slovenian: Ločeni zdravili, ki vsebujeta le dolutegravir oziroma le rilpivirin, sta na voljo za primere, ko je treba eno od učinkovin prenehati jemati, ali ko je treba spremeniti njen odmerek (glejte poglavje 4.5).
English: • increase in pancreatic amylase (a digestive enzyme).
Slovenian: • zvišanje pankreatične amilaze (prebavnega encima).
English: Rilpivirine ↔ (Not studied)
Slovenian: rilpivirin ↔ (Ni raziskano)
English: The combination of Juluca and dabigatran etexilate should be used with caution.
Slovenian: Kombinacijo zdravila Juluca in dabigatran eteksilata je treba uporabljati previdno.
English: Rifampicin/ Rilpivirine1,2
Slovenian: rifampicin/rilpivirin1,2
English: Do not take Juluca if you are taking any of the following medicines as they may affect the way Juluca works: - dofetilide (a medicine to treat heart conditions).
Slovenian: Ne jemljite zdravila Juluca, če jemljete katero od spodaj naštetih zdravil, ker lahko ta zdravila lahko vplivajo na delovanje zdravila Juluca:
English: Don't stop taking Juluca without advice from your doctor Take Juluca for as long as your doctor recommends.
Slovenian: Ne prenehajte jemati zdravila Juluca, ne da bi se posvetovali z zdravnikom