natgillin/translations-raw huggingface dataset:
Juluca must not be taken with some other medicines (see ‘Do not take Juluca' earlier in section 2).
Juluca se ne smije se uzimati zajedno s određenim lijekovima (pogledajte odlomak ‘Nemojte uzimati lijek Juluca', naveden ranije u ovom dijelu).
In previously untreated patients receiving dolutegravir + 2 NRTIs in Phase IIb and Phase III, no development of resistance to the integrase class, or to the NRTI class was seen (n=876, follow-up of 48-96 weeks).
U prethodno neliječenih bolesnika koji su u ispitivanjima faze IIb i faze III primali dolutegravir + 2 nukleozidna inhibitora reverzne transkriptaze (NRTI) nije primijećen razvoj rezistencije na skupinu inhibitora integraze ni na skupinu NRTI-ja (n=876, praćenje u trajanju od 48 - 96 tjedana).
Available toxicological data in animals has shown excretion of dolutegravir and rilpivirine in milk.
Dostupni toksikološki podaci prikupljeni u životinja pokazuju da se dolutegravir i rilpivirin izlučuju u mlijeko.
** Non-inferiority of dolutegravir plus rilpivirine to CAR, in the proportion of subjects classified as virologic non-responders, was demonstrated using a non-inferiority margin of 4%.
** Neinferiornost dolutegravira plus rilpivirina u odnosu na dotadašnji kombinirani antiretrovirusni režim među ispitanicima koje se smatralo bolesnicima bez virološkog odgovora dokazana je koristeći graničnu vrijednost neinferiornosti od 4%.
Virologic Outcomes of Randomized Treatment at Week 48 (Snapshot algorithm)
Tablica 3: Virološki ishodi randomiziranog liječenja u 48. tjednu (algoritam za globalnu snimku distribuiranog sustava [engl. snapshot algoritam])
Juluca should not be co-administered at the same time as antacids.
Juluca se ne smije primjenjivati istodobno s antacidima.
As dolutegravir and rilpivirine are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.2).
Budući da se dolutegravir i rilpivirin u velikoj mjeri vežu za proteine u plazmi, nije vjerojatno da će se značajno ukloniti hemodijalizom ili peritonejskom dijalizom (vidjeti dio 4.2).
No mother to child transmission was identified.
Nije utvrđen nijedan slučaj prijenosa infekcije s majke na dijete.
Keep this medicine out of the sight and reach of children.
Kako čuvati lijek Juluca Lijek čuvajte izvan pogleda i dohvata djece.
Patients with hepatitis B or C
Bolesnici s hepatitisom B ili C
White HDPE (high density polyethylene) bottles closed with polypropylene child-resistant closures, with a polyethylene faced induction heat seal liner.
Bijele boce od polietilena visoke gustoće (HDPE) zatvorene polipropilenskim zatvaračima sigurnima za djecu i polietilenskom toplinski zavarenom zaštitnom folijom.
Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median IC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/mL).
Rilpivirin je pokazao aktivnost protiv laboratorijskih sojeva divljeg tipa HIV-1 u akutno zaraženoj T-staničnoj liniji, uz medijan vrijednosti IC50 za HIV-1/IIIB od 0,73 nM (0,27 ng/ml).
Renal elimination of rilpivirine is negligible.
Eliminacija rilpivirina kroz bubrege je zanemariva.
The safety and efficacy of Juluca in pregnancy have not yet been established.
Sigurnost i djelotvornost lijeka Juluca u trudnica još nisu ustanovljene.
No data are available in patients with severe hepatic impairment (Child-Pugh score C); therefore Juluca is not recommended in these patients (see section 5.2).
Nema dostupnih podataka o bolesnicima s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C), pa se u tih bolesnika ne preporučuje primjena lijeka Juluca (vidjeti dio 5.2).
The most severe adverse reaction, possibly related to the treatment with dolutegravir (from pooled from Phase IIb and Phase III clinical studies), seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4).
Najteža nuspojava koja bi mogla biti povezana s liječenjem dolutegravirom (prema objedinjenim podacima iz kliničkih ispitivanja faze IIb i faze III), primijećena u samo jednog bolesnika, bila je reakcija preosjetljivosti koja je uključivala osip i teške učinke na jetru (vidjeti dio 4.4).
• increase in lipase (an enzyme involved in breaking down fats)
• povećanje vrijednosti lipaze (enzima koji sudjeluje u razgradnji masnoća)
This patient's viral load was 1,059,771 copies/mL at the suspected virologic withdrawal visit and was <50 copies/mL at the withdrawal visit.
Virusno opterećenje tog bolesnika bilo je 1 059 771 kopija/ml pri posjetu na kojem se posumnjalo na virološki neuspjeh te
Each film-coated tablet contains 52 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 52 mg laktoze (u obliku hidrata).
If you take too many tablets of Juluca contact your doctor or pharmacist immediately.
Ako uzmete previše Juluca tableta, odmah se obratite svom liječniku ili ljekarniku.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACKS ONLY - WITH BLUE BOX)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (SAMO VIŠESTRUKA PAKIRANJA - S PLAVIM OKVIROM)
In vitro, dolutegravir was not a substrate of human OATP 1B1, OATP 1B3 or OCT 1.
In vitro, dolutegravir nije bio supstrat ljudskih prijenosnika OATP1B1, OATP1B3 ni OCT1.
Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Lijekovi koji induciraju ili inhibiraju CYP3A mogu stoga utjecati na klirens rilpivirina (vidjeti dio 5.2).
The effect of rilpivirine at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
Učinak rilpivirina u preporučenoj dozi od 25 mg jedanput na dan na QTcF interval ocjenjivao se u randomiziranom, placebom i aktivnim lijekom (moksifloksacin 400 mg jedanput na dan) kontroliranom ukriženom ispitivanju provedenom u 60 zdravih odraslih osoba, u kojem je provedeno 13 mjerenja tijekom razdoblja od 24 sata u stanju dinamičke ravnoteže.
The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09
Srednja vrijednost IC50 za 3 izolata HIV-2 iznosila je 0,18 nM (raspon:
Subjects with hepatitis B co-infection or hepatitis C infection in need of anti-HCV therapy were excluded from studies with the dual combination of dolutegravir and rilpivirine.
Ispitanici s istodobnom infekcijom virusom hepatitisa B ili ispitanici s infekcijom virusom hepatitisa C kojima je bila potrebna terapija za liječenje HCV infekcije nisu bili uključeni u ispitivanja dvojne kombinacije dolutegravira i rilpivirina.
Using strain NL432, integrase mutations E92Q (fold change [FC] 3) and G193E (FC 3) were selected.
NL432, izdvojene su mutacije integraze E92Q (vrijednost promjene [engl. fold change, FC] 3) i
Rifabutin/ Rilpivirine1 300 mg once daily2
rifabutin / rilpivirin1 300 mg jedanput na dan2
In reproductive toxicity studies in animals, dolutegravir was shown to cross the placenta.
Ispitivanja reproduktivne toksičnosti na životinjama pokazala su da dolutegravir prolazi kroz placentu.
Juluca has not been studied in patients on dialysis.
Juluca se nije ispitivala u bolesnika na dijalizi.
In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the CYP3A system.
Eksperimenti in vitro ukazuju na to da rilpivirin prvenstveno podliježe oksidacijskom metabolizmu posredovanom enzimima sustava CYP3A.
Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.
Rilpivirin nije inducirao oštećenje kromosoma u mikronukleusnom testu in vivo u miševa.
If the next dose is due within 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Ako je do sljedeće doze preostalo manje od 12 sati, bolesnik ne smije uzeti propuštenu dozu, nego samo nastaviti s primjenom prema uobičajenom rasporedu.
Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Aktivnosti rilpivirina posredovana je nekompetitivnom inhibicijom reverzne transkriptaze (RT) virusa HIV-1.
25-O-desacetyl-rifabutin
25-O-dezacetilrifabutin
Rilpivirine-resistant strains were selected in cell culture starting from wild type HIV-1 of different origins and clades as well as NNRTI-resistant HIV-1.
Sojevi rezistentni na rilpivirin izdvojeni su u staničnoj kulturi, počevši od virusa HIV-1 divljeg tipa različitog podrijetla i podtipova te virusa HIV-1 rezistentnog na NNRTI.
(reduced absorption due to gastric pH increase).
(Smanjena apsorpcija zbog povećanja želučane pH
Rilpivirine studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function.
Ispitivanja rilpivirina na životinjama nisu pokazala dokaze relevantne toksičnosti za zametak ili plod ni učinak na reproduktivnu funkciju.
Table 1:
Tablicu 1).
Rilpivirine inhibits P-gp in vitro (IC50 is 9.2 μM).
P-gp in vitro (IC50 iznosi 9,2 μM).
Rilpivirine is primarily metabolised by CYP3A.
Rilpivirin se prvenstveno metabolizira posredstvom CYP3A.
The absolute bioavailability of dolutegravir or rilpivirine has not been established.
Apsolutna bioraspoloživost dolutegravira ili rilpivirina nije ustanovljena.
Dolutegravir or rilpivirine did not change ethinyl estradiol and norelgestromin (dolutegravir) or norethindrone (rilpivirine) plasma concentrations to a clinically relevant extent.
Dolutegravir i rilpivirin nisu promijenili plazmatske koncentracije etinilestradiola i norelgestromina (dolutegravir) ni noretindrona
Rilpivirine has tested negative in the absence and presence of a metabolic activation system in the in vitro Ames reverse mutation assay and the in vitro clastogenicity mouse lymphoma assay.
Rezultati testiranja rilpivirina bili su negativni u odsutnosti i prisutnosti sustava metaboličke aktivacije u Amesovu testu reverzne mutacije in vitro i testu klastogenosti na mišjem limfomu in vitro.
Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Rilpivirin primijenjen u preporučenoj dozi od 25 mg jedanput na dan nije povezan s klinički značajnim učinkom na QTc interval.
Warnings and precautions Talk to your doctor or, pharmacist before taking Juluca.
Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Juluca.
Subjects were randomised 1:1 to continue their CAR or be switched to a two-drug regimen dolutegravir plus rilpivirine administered once daily.
Ispitanici su bili randomizirani u omjeru 1:1 za nastavak liječenja dotadašnjim antiretrovirusnim režimom ili za prelazak na dvojni režim liječenja dolutegravirom plus rilpivirinom jedanput na dan.
Dolutegravir pharmacokinetics are similar between healthy and HIV-infected subjects.
Farmakokinetika dolutegravira slična je u zdravih ispitanika i u onih s HIV infekcijom.
common increased bilirubin uncommon hepatitis rare acute hepatic failure**
često povišene vrijednosti bilirubina manje često hepatitis rijetko akutno zatajenje jetre**
No efficacy and safety data are available for the combination of dolutegravir and rilpivirine in pregnancy.
Nema dostupnih podataka o djelotvornosti i sigurnosti primjene kombinacije dolutegravira i rilpivirina u trudnoći.
Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Rilpivirin je inhibitor prijenosnika MATE-2K in vitro, uz IC50 od < 2,7 nM.
Limited data are available regarding the use of dolutegravir during pregnancy.
Dostupni su ograničeni podaci o primjeni dolutegravira tijekom trudnoće.
Metformin is eliminated renally and therefore it is of importance to monitor renal function when co-treated with Juluca.
Metformin se izlučuje putem bubrega, stoga je važno nadzirati bubrežnu funkciju kada se primjenjuje istodobno s lijekom Juluca.
A study of the pharmacokinetics of dolutegravir was performed in subjects with severe renal impairment (CLcr <30 mL/min) and matched healthy controls.
Ispitivanje farmakokinetike dolutegravira provedeno je u ispitanika s teškim oštećenjem bubrežne funkcije (CLcr < 30 ml/min) i farmakokinetika je odgovarala onoj u zdravih kontrolnih ispitanika.
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).
U bolesnika koji su neuspješno odgovorili na prethodne terapije, ali nisu primali lijekove iz skupine inhibitora integraze (ispitivanje SAILING), supstitucije povezane s rezistencijom na inhibitore integraze primijećene su u 4/354 bolesnika (praćenje od 48 tjedana) liječenih dolutegravirom, koji se primjenjivao u kombinaciji s osnovnim režimom liječenja po izboru ispitivača.
The pharmacokinetic properties of rilpivirine have been evaluated in adult healthy subjects and in adult antiretroviral treatment-naïve HIV-1 infected patients.
Farmakokinetička svojstva rilpivirina ocjenjivala su se u zdravih odraslih ispitanika i u odraslih bolesnika s HIV-1 infekcijom koji se prethodno nisu liječili antiretroviroticima.
Therefore, use of Juluca during pregnancy is not recommended (see sections 4.4, 4.6, 5.1 and 5.2).
Stoga se primjena lijeka Juluca tijekom trudnoće ne preporučuje (vidjeti dijelove 4.4, 4.6, 5.1 i 5.2).
Some medicines can affect how Juluca works, or make it more likely that you will have side effects.
Neki lijekovi mogu utjecati na način djelovanja lijeka Juluca ili povećati vjerojatnost pojave nuspojava.
A reduction in the antiviral activity of rilpivirine was observed in the presence of 1 mg/mL alpha-1-acid glycoprotein, 45 mg/mL human serum albumin, and 50% human serum as demonstrated by median IC50 rates of 1.8, 39.2 and 18.5, respectively.
U prisutnosti 1 mg/ml alfa-1-kiselog glikoproteina, 45 mg/ml ljudskog serumskog albumina i 50% ljudskog seruma opaženo je smanjenje antivirusne aktivnosti rilpivirina, što pokazuju medijani stopa IC50 od 1,8, 39,2 odnosno 18,5.
Liver problems including hepatitis B and/or C
Jetrene tegobe, uključujući hepatitis B i/ili C
Dolutegravir activity was determined against a panel of 60 INI-resistant site-directed mutant HIV-1 viruses (28 with single substitutions and 32 with 2 or more substitutions).
Virusni izolat s ciljanom mutagenezom rezistentan na inhibitore integraze Aktivnost dolutegravira određivala se protiv palete od 60 izolata HIV-1 s ciljanom mutagenezom rezistentnih na inhibitore integraze (28 izolata s jednom supstitucijom i 32 izolata s 2 ili više supstitucija).
• symptoms of infections and inflammation
• simptome infekcija i upale
If you vomit less than 4 hours after taking Juluca, take another tablet with a meal.
Ako povratite manje od 4 sata nakon uzimanja lijeka Juluca, uzmite još jednu tabletu uz obrok.
These medicinal products are recommended to be administered 12 hours before or 4 hours after Juluca (see section 4.5).
Te se lijekove preporučuje primijeniti 12 sati prije ili 4 sata nakon lijeka Juluca (vidjeti dio 4.5).
After single dose oral administration of 14C-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
Nakon peroralne primjene jedne doze 14C-rilpivirina u prosjeku je 85% doze pronađeno u fecesu, a 6,1% u mokraći.
No dosage adjustment is considered necessary for patients with mild to moderate hepatic impairment (ChildPugh score A or B).
Ne smatra se potrebnim prilagođavati dozu u bolesnika s blagim do umjerenim oštećenjem jetrene funkcije (Child-Pugh stadij A ili B).
Phosphodiesterase type 5 (PDE-5) inhibitors Sildenafil /
Inhibitori fosfodiesteraze tipa 5 (PDE-5) sildenafil / dolutegravir sildenafil / rilpivirin1,2
CAR = current antiretroviral regimen; DTG+RPV = dolutegravir plus rilpivirine; INI = Integrase inhibitor; NNRTI = Non-nucleoside reverse transcriptase inhibitor; PI = Protease Inhibitor
DTG+RPV = dolutegravir plus rilpivirin; NNRTI = nenukleozidni inhibitor reverzne transkriptaze
These medicinal products are recommended to be administered 6 hours before or 4 hours after Juluca (see section 4.5).
Te se lijekove preporučuje primijeniti 6 sati prije ili 4 sata nakon lijeka Juluca (vidjeti dio 4.5).
Dolutegravir is eliminated mainly through metabolism by uridine diphosphate glucuronosyl transferase (UGT)1A1.
Dolutegravir se uglavnom eliminira metabolizmom u kojem posreduje uridindifosfat glukuronoziltransferaza 1A1 (engl. uridine diphosphate glucuronosyl transferase, UGT1A1).
Lower exposures of dolutegravir and rilpivirine were observed during pregnancy (see sections 4.2, 4.4, 5.1,
Primijećena je manja izloženost dolutegraviru i rilpivirinu tijekom trudnoće (vidjeti dijelove 4.2, 4.4, 5.1 i 5.2).
In the case of the Q148-mutation viruses, increasing dolutegravir FC is seen as the number of secondary mutations increase.
Kod virusa s mutacijom Q148 je s porastom broja sekundarnih mutacija primijećen i porast FC-a za dolutegravir.
In vitro, dolutegravir inhibited the renal organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter 1 (MATE1).
Dolutegravir je in vitro inhibirao bubrežni prijenosnik organskih kationa 2 (engl. organic cation transporter 2, OCT2) i prijenosnik za izlučivanje više lijekova i toksina (engl. multidrug and toxin extrusion transporter 1, MATE1).
Frequency category*
Kategorija učestalosti*
The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 30 and 1.2 times the 50 mg human clinical exposure based on AUC, respectively.
Primarni učinak dolutegravira bile su gastrointestinalna nepodnošljivost ili iritacija u štakora odnosno majmuna pri dozama koje su izazvale sistemsku izloženost približno 30 odnosno 1,2 puta veću od kliničke izloženosti u ljudi pri primjeni doze od 50 mg, što je utvrđeno na temelju AUC-a.
From rilpivirine Phase III trials, in the week 48 pooled resistance analysis conducted with previously untreated patients, 62 (of a total of 72) virologic failures in the rilpivirine arm had resistance data at baseline and time of failure.
Prema analizi objedinjenih podataka o rezistenciji u 48. tjednu ispitivanja rilpivirina faze III provedenih u prethodno neliječenih bolesnika, za 62 (od ukupno 72) bolesnika s virološkim neuspjehom u skupini liječenoj rilpivirinom postojali su podaci o rezistenciji na početku ispitivanja i u trenutku neuspjeha.
→ Use of Juluca is not recommended.
Primjena lijeka Juluca se ne preporučuje.
A mean change from baseline of 8.22 µmol/L (range -26.5 to 51.2 µmol/L) was observed after 48 weeks treatment.
Nakon 48 tjedana liječenja primijećena je srednja vrijednost promjene od 8,22 µmol/l (raspon od -26,5 do 51,2 µmol/l) u odnosu na početnu vrijednost.
Rilpivirine demonstrated limited in vitro activity against HIV-2 with IC50 values ranging from 2,510 to 10,830 nM.
Rilpivirin je pokazao ograničenu aktivnost in vitro protiv HIV-2, uz vrijednosti IC50 u rasponu od 2510 do 10 830 nM.
Limited data is available in patients with hepatitis C co-infection.
Dostupni su ograničeni podaci o primjeni u bolesnika s istodobnom infekcijom virusom hepatitisa C.
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.
Iako je ukupna koncentracija dolutegravira u plazmi bila podjednaka, u ispitanika s umjerenim oštećenjem jetrene funkcije izloženost nevezanom dolutegraviru bila je 1,5 do 2 puta veća nego u zdravih ispitanika.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET ViiV Healthcare BV
Dexamethasone/ Rilpivirine (systemic, except for single dose use)
deksametazon / dolutegravir deksametazon / rilpivirin (sistemski, osim kod primjene samo jedne doze)
Rilpivirine ↔ AUC ↓ 5%
rilpivirin ↔ AUC ↓ 5%
Dolutegravir is primarily metabolized through glucuronidation via UGT1A1 with a minor CYP3A component.
Dolutegravir se prvenstveno metabolizira glukuronidacijom putem UGT1A1, a manjim dijelom posredstvom CYP3A.
A dose adjustment of metformin should be considered when starting and stopping coadministration of Juluca with metformin, to maintain glycaemic control.
Potrebno je razmotriti prilagodbu doze metformina kod započinjanja ili prekidanja istodobne primjene lijeka Juluca i metformina, da bi se održala kontrola glikemije.
At supra-therapeutic doses (75 and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5 and 5.1).
Primjena rilpivirina u dozama većima od terapijskih (75 mg i 300 mg jedanput na dan) povezana je s produljenjem QTc intervala na elektrokardiogramu (EKG) (vidjeti dijelove 4.5 i 5.1).
In a Week 96 pooled analyses of virologic failures with baseline viral load ≤100,000 copies/mL and resistance to rilpivirine (n = 5), subjects had cross-resistance to efavirenz (n = 3), etravirine (n = 4), and nevirapine (n = 1).
Prema analizama objedinjenih podataka o bolesnicima s virološkim neuspjehom koji su na početku ispitivanja imali virusno opterećenje ≤ 100 000 kopija/ml i rezistenciju na rilpivirin (n = 5), provedenima u 96. tjednu, ispitanici su imali križnu rezistenciju na efavirenz (n = 3), etravirin (n = 4) i nevirapin (n = 1).
As dolutegravir and rilpivirine are highly bound to plasma proteins, dialysis is unlikely to result in significant removal of the active substances.
Budući da se dolutegravir i rilpivirin u velikoj mjeri vežu za proteine u plazmi, nije vjerojatno da će se te djelatne tvari značajno ukloniti dijalizom.
Neither Juluca nor the combination dolutegravir and rilpivirine as single entities have been studied in children.
Ni Juluca ni kombinacija dolutegravira i rilpivirina kao zasebnih lijekova nisu se ispitivali u djece.
No clinically important pharmacokinetic differences of dolutegravir or rilpivirine due to race have been identified.
Nisu utvrđene klinički važne razlike u farmakokinetici dolutegravira ili rilpivirina povezane s rasom.
No dose adjustment of oral contraceptives is required when co-administered with Juluca.
Nije potrebno prilagođavati dozu oralnih kontraceptiva pri njihovoj istodobnoj primjeni s lijekom Juluca.
Steadystate administration of rilpivirine 75 mg once daily and 300 mg once daily resulted in a mean Cmax approximately 2.6-fold and 6.7-fold, respectively, higher than the mean steady-state Cmax observed with the recommended 25 mg once daily dose of rilpivirine (see section 4.4).
Primjena rilpivirina u dozi od 75 mg jedanput na dan i 300 mg jedanput na dan u stanju dinamičke ravnoteže dovela je do srednje vrijednosti Cmax koja je bila približno 2,6 puta odnosno 6,7 puta veća od srednje vrijednosti Cmax u stanju dinamičke ravnoteže opažene kod primjene preporučene doze rilpivirina od 25 mg jedanput na dan (vidjeti dio 4.4).
increase).
vrijednosti).
In this analysis, the resistance-associated mutations (RAMs) associated with NNRTI resistance that developed in at least 2 rilpivirine virologic failures were: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y, and F227C.
U toj su analizi utvrđene sljedeće mutacije povezane s rezistencijom na NNRTI-je koje su se razvile u najmanje 2 bolesnika liječena rilpivirinom koja su doživjela virološki neuspjeh: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y i F227C.
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.
Između analize u 48. tjednu i one u 96. tjednu zabilježena su dodatna 24 (3,5%) slučaja virološkog neuspjeha u skupini liječenoj rilpivirinom i 14 (2,1%) u onoj liječenoj efavirenzom.
How to take Juluca
Kako uzimati lijek Juluca
Lower exposures of dolutegravir and rilpivirine were observed during pregnancy.
Primijećena je manja izloženost dolutegraviru i rilpivirinu tijekom trudnoće.
Azole anti-fungals Ketoconazole/ Dolutegravir Ketoconazole/ Rilpivirine1,2
Azolni antifungici ketokonazol / dolutegravir ketokonazol / rilpivirin1,2