natgillin/translations-raw huggingface dataset:
2 This interaction study has been performed with a dose higher than the recommended dose for rilpivirine assessing the maximal effect on the co-administered drug.
V tej študiji medsebojnega delovanja je bil uporabljeni odmerek rilpivirina večji od priporočenega odmerka, da bi lahko ocenili največji učinek na sočasno uporabljeno zdravilo.
INFORMATION IN BRAILLE juluca
PODATKI V BRAILLOVI PISAVI juluca
Systemic exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects.
Sistemska izpostavljenost rilpivirinu je bila pri bolnikih, okuženih s HIV-1, praviloma manjša kot pri zdravih osebah.
Moderate and high fat meals increased the dolutegravir AUC(0-∞) by approximately 87% and Cmax by approximately 75%.
Zmerno in zelo mastni obroki so povečali AUC(0-∞) dolutegravirja za približno 87 % in njegovo Cmax za približno 75 %.
If you notice within 12 hours of the time you usually take Juluca, you must take the tablet as soon as possible.
Če to opazite v 12 urah po tem, ko po navadi vzamete zdravilo Juluca, vzemite tableto čim prej.
Within-subject variability (CVw%) is lower than between-subject variability.
Intraindividualna variabilnost (KVw%) je manjša kot interindividualna variabilnost.
• medicines that may cause a life threatening irregular heartbeat (Torsade de Pointes).
• zdravila, ki lahko povzročijo smrtno nevarno motnjo srčnega ritma (Torsade de Pointes).
• increase in bilirubin (a test of liver function) in your blood.
• zvišanje bilirubina (preiskave delovanja jeter) v krvi.
The single amino acid substitutions associated with a loss of susceptibility to rilpivirine were: K101P, Y181I and Y181V.
Enojne aminokislinske substitucije, povezane z izgubo občutljivosti za rilpivirin, so bile: K101P, Y181I in Y181V.
In the trials, the presence of the mutations V90I and V189I, at baseline, did not affect response.
V kliničnih preskušanjih izhodiščna prisotnost mutacij V90I in V189I ni vplivala na odziv.
If you are taking any of the above, ask your doctor about alternatives.
Če jemljete katero zgoraj naštetih zdravil, se z zdravnikom posvetujte o alternativah.
QT prolonging medicinal products
Zdravila, ki podaljšajo interval QT
Therefore, use of Juluca during pregnancy is not recommended (see sections 4.4, 4.6, 5.1 and 5.2).
Zato uporaba zdravila Juluca med nosečnostjo ni priporočljiva (glejte poglavja 4.4, 4.6, 5.1 in 5.2).
• aches and pains in the joints (especially in the hip, knee or shoulder)
• bolečine v sklepih (zlasti v kolku, kolenu ali rami),
• low white blood cell count
• majhno število belih krvnih celic,
Take the rilpivirine tablet at the same time you take Juluca.
Tableto rilpivirina vzemite hkrati z zdravilom Juluca.
When Juluca was taken with a meal, the absorption of both dolutegravir and rilpivirine was increased.
Če je bilo zdravilo Juluca uporabljeno z obrokom, se je povečala tako absorpcija dolutegravirja kot rilpivirina.
The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Farmakokinetike rilpivirina niso proučevali pri bolnikih z insuficienco ledvic.
The IC50 for dolutegravir against various laboratory strains using PBMC was 0.5 nM, and when using MT-4 cells it ranged from 0.7-2 nM.
IC50 dolutegravirja proti različnim laboratorijskim sevom z uporabo PBMC je bila 0,5 nM, ob uporabi celic MT-4 pa je segala od 0,7 do 2 nM.
• decreased number of platelets, which are involved in blood clotting
• zmanjšano število trombocitov, ki sodelujejo pri strjevanju krvi,
common increased bilirubin uncommon hepatitis rare acute hepatic failure**
pogosti zvišanje bilirubina občasni hepatitis redki akutna odpoved jeter**
All other drug-drug interactions shown are predicted.
Vsa druga prikazana medsebojna delovanja so na podlagi predvidevanj.
Rifabutin, a medicine to treat some bacterial infections, can lower the amount of Juluca in your body and make it less effective.
Rifabutin, zdravilo za zdravljenje nekaterih bakterijskih okužb, lahko zmanjša količino zdravila Juluca v telesu in zmanjša njegovo učinkovitost.
Each film-coated tablet contains 52 mg lactose (as monohydrate).
Ena filmsko obložena tableta vsebuje 52 mg laktoze (v obliki monohidrata).
• signs or symptoms of inflammation or infection, for example fever, chills, sweats (immune reactivation syndrome).
• znaki ali simptomi vnetja ali okužbe, na primer zvišana telesna temperatura, mrzlica, potenje (sindrom imunske reaktivacije).
This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance [CrCl] 45- 59 mL/min) and a cautious approach is recommended.
Ta kombinacija lahko pri bolnikih z zmerno okvaro ledvic (stadij 3a, očistek kreatinina [CrCl] 45-59 ml/min) poveča tveganje za laktacidozo, zato je priporočljiva previdnost.
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Pri bolnikih, okuženih s HIV, ki imajo v času uvedbe kombiniranega protiretrovirusnega zdravljenja hudo imunsko pomanjkljivost, se lahko pojavi vnetna reakcija na asimptomatske ali rezidualne oportunistične patogene ter povzroči resna klinična stanja ali poslabšanje simptomov.
common decreased appetite increased triglycerides (fasted) Psychiatric disorders very common insomnia common abnormal dreams depression sleep disorders depressed mood anxiety uncommon suicidal ideation or suicide attempt (particularly in patients with a pre-existing history of depression or psychiatric illness)
Psihiatrične motnje zelo pogosti nespečnost pogosti nenormalne sanje depresija motnje spanja depresivno razpoloženje anksioznost občasni samomorilno razmišljanje ali poskus samomora (zlasti pri bolnikih z anamnezo depresije ali psihiatrične bolezni)
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.
Proti rilpivirinu odporni sevi so bili izbrani v celični kulturi, tako iz od HIV-1 divjega tipa rrazličnih izvorov in podtipov, kot iz NNRTI-odpornega HIV-1.
Some medicines can affect how Juluca works, or make it more likely that you will have side effects.
Nekatera zdravila lahko vplivajo na delovanje zdravila Juluca ali povečajo verjetnost, da se vam pojavijo neželeni učinki.
Hypersensitivity reactions have been reported with dolutegravir, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions.
Med uporabo dolutegravirja so bile opisane preobčutljivostne reakcije za katere so bili značilni izpuščaj, konstitucijski znaki in v nekaterih primerih moteno delovanje organov, vključno s hudimi jetrnimi reakcijami.
The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09
Povprečna IC50 za 3 izolate HIV-2 je bila 0,18 nM
This may result in loss of therapeutic effect of Juluca.
To lahko povzroči izgubo terapevtskega učinka zdravila Juluca.
In further selection experiments using clinical isolates of subtype B, mutation R263K was seen in all five isolates (after 20 weeks and onwards).
Pri nadaljnjih preskušanjih selekcije z uporabo kliničnih izolatov podtipa B so pri vseh petih izolatih opazili mutacijo R263K (od 20. tedna naprej).
Juluca should not be co-administered at the same time as H2-receptor antagonists.
Zdravila Juluca se ne sme vzeti sočasno z antagonisti receptorjev H2.
In a panel of 67 HIV-1 recombinant laboratory strains with one amino acid substitution at RT positions associated with NNRTI resistance, including the most commonly found K103N and Y181C, rilpivirine showed antiviral activity (FC≤BCO) against 64 (96%) of these strains.
V skupini 67 rekombinantnih laboratorijskih sevov HIV-1 z eno aminokislinsko substitucijo na položajih RT, povezano z odpornostjo proti NNRTI, vključno z najpogostejšima K103N in Y181C, je rilpivirin pokazal protivirusno aktivnost (FC ≤ BCO) proti 64 (96 %) od teh sevov.
Animal studies indicate no clinically relevant effects on male or female fertility (see section 5.3).
Študije na živalih ne kažejo klinično pomembnih vplivov na plodnost moških ali žensk (glejte poglavje 5.3).
The adverse reactions considered at least possibly related to treatment with the components of Juluca from clinical studies and post-marketing experience are listed in Table 2 by body system, organ class and frequency.
Neželeni učinki, ki veljajo za vsaj morebitno povezane z učinkovinama zdravila Juluca, zabeleženi v kliničnih študijah in po prihodu zdravila na trg, so navedeni v preglednici 2, razporejeni po organskih sistemih, organski skupini in pogostnosti.
Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Zdravila, ki inducirajo ali zavirajo CYP3A, lahko zaradi tega vplivajo na očistek rilpivirina (glejte poglavje 5.2).
Phosphodiesterase type 5 (PDE-5) inhibitors Sildenafil /
Zaviralci fosfodiesteraze tipa 5 (PDE-5) Sildenafil/ dolutegravir
1 The interaction between dolutegravir and/or rilpivirine and the medicinal product was evaluated in a clinical study.
Medsebojno delovanje med dolutegravirjem in/ali rilpivirinom in tem zdravilom je bilo ocenjeno v klinični študiji.
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 breme pri tem bolniku je bilo pri pregledu ob domnevnem virološkem neuspehu 1.059.771 kopij/mL in < 50 kopij/ml pri pregledu ob opustitvi.
Available toxicological data in animals has shown excretion of dolutegravir and rilpivirine in milk.
Razpoložljivi toksikološki podatki pri živalih kažejo, da se dolutegravir in rilpivirin izločata v mleku.
In vitro, dolutegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
Dolutegravir in vitro ni induciral CYP1A2, CYP2B6 ali CYP3A4.
The single INI-resistance substitutions T66K, I151L, and S153Y conferred a greater than 2-fold decrease in dolutegravir susceptibility (range: 2.3fold to 3.6-fold from reference).
Z odpornostjo proti INI povezane točkovne substitucije INI, T66K, I151L in S153Y so povzročile več kot 2-kratno zmanjšanje občutljivosti za dolutegravir (razpon: od 2,3- do 3,6-kratno v primerjavi z referenčno vrednostjo).
Patients with hepatitis B or C
Bolniki s hepatitisom B ali C
Delay in stopping treatment with Juluca after the onset of hypersensitivity may result in a life-threatening allergic reaction.
Odlašanje s prenehanjem uporabe zdravila Juluca po začetku preobčutljivostne reakcije lahko povzroči smrtno nevarno alergijsko reakcijo.
The efficacy and safety of switching from an antiretroviral regimen (containing 2 NRTIs plus either an INI, an NNRTI, or a PI) to a dual regimen of dolutegravir 50 mg and rilpivirine 25 mg was evaluated in 2 identical 48-week, randomised, open-label, multicentre, parallel-group, non-inferiority studies SWORD-1 (201636) and SWORD-2 (201637).
Učinkovitost in varnost prehoda s protiretrovirusne sheme (ki je obsegala 2 NRTI ter kot tretje zdravilo ali INI ali NNRTI ali PI) na dvotirno shemo s 50 mg dolutegravirja in 25 mg rilpivirina so ocenili v 2 identičnih 48-tedenskih randomiziranih, vzporednih, odprtih, multicentričnih študijah neinferiornosti SWORD-1 (201636) in SWORD-2 (201637).
If you take rifabutin, your doctor may need to give you an additional dose of rilpivirine to treat your HIV infection (see section 3, ‘How to take Juluca')
Če jemljete rifabutin, vam bo zdravnik za zdravljenje okužbe z virusom HIV morda predpisal dodaten odmerek rilpivirina (glejte poglavje 3, "Kako jemati zdravilo Juluca"),
Juluca should be prescribed by physicians experienced in the management of HIV infection.
Zdravilo Juluca mora predpisati zdravnik, ki ima izkušnje z zdravljenjem okužbe s HIV.
Other medicines and Juluca
Druga zdravila in zdravilo Juluca
Similar IC50s were seen for clinical isolates without any major difference between subtypes; in a panel of 24 HIV-1 isolates of clades A, B, C, D, E, F and G and group O the mean IC50 value was 0.2 nM (range 0.02-2.14).
Podobne IC50 so ugotovili pri kliničnih izolatih, brez večje razlike med podtipi; v skupini 24 izolatov HIV-1 podtipov A, B, C, D, E, F in G ter skupine O je bila povprečna IC50 0,2 nM (razpon: od 0,02 do 2,14).
Selected established and theoretical interactions between dolutegravir, rilpivirine and co-administered medicinal products are listed in Table 1.
Izbrana ugotovljena in teoretično možna medsebojna delovanja med dolutegravirjem, rilpivirinom in sočasno uporabljenimi zdravili so prikazana v Preglednici 1.
The unbound fraction of dolutegravir in plasma is increased at low levels of serum albumin (<35 g/L) as seen in subjects with moderate hepatic impairment.
Delež nevezanega dolutegravirja v plazmi se poveča v primeru majhne koncentracije albumina v serumu (< 35 g/l), kakršna je opazna pri osebah z zmerno okvaro jeter.
Based on this data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of major enzymes or transporters (see section 4.5).
Na podlagi teh podatkov ni pričakovati, da bi dolutegravir vplival na farmakokinetiko zdravil, ki so substrati pomembnih encimov ali prenašalcev (glejte poglavje 4.5).
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).
Pri predhodno nezdravljenih bolnikih, ki so prejemali dolutegravir + 2 NRTI v študijah faze IIb in III, niso opazili odpornosti proti zdravilom iz skupine zaviralcev integraze ali NRTI (n = 876, spremljanje od 48 do 96 tednov).
Juluca should not be taken with any other medicinal product containing dolutegravir or rilpivirine, except in case of co-administration with rifabutin (see section 4.5).
Zdravila Juluca se ne sme jemati skupaj z nobenim drugim zdravilom, ki vsebuje dolutegravir ali rilpivirin, razen v primeru sočasnega zdravljenja z rifabutinom (glejte poglavje 4.5).
Two subjects across the pooled SWORD-1 (201636) and SWORD-2 (201637) studies from each treatment arm experienced confirmed virologic failure leading to withdrawal at any time through Week 48.
V združenih študijah SWORD-1 (201636) in SWORD-2 (201637) se je pri dveh preiskovancih iz vsake terapevtske skupine pojavil potrjen virološki neuspeh, ki je povzročil prenehanje uporabe zdravila v obdobju do 48. tedna.
AUC in cervicovaginal fluid, cervical tissue and vaginal tissue were 6-10% of those in corresponding plasma at steady state.
AUC v cervikovaginalni tekočini, tkivu materničnega vratu in nožničnem tkivu je bila od 6 do 10 % AUC v plazmi v stanju dinamičnega ravnovesja.
Iron oxide yellow (E172) Iron oxide red (E172)
Rdeči železov oksid (E172)
Dosing recommendations for paediatric patients cannot be made due to insufficient data (see section 4.2).
Zaradi nezadostnih podatkov ni mogoče dati priporočil za odmerjanje pri pediatričnih bolnikih (glejte poglavje 4.2).
The most frequently reported adverse reactions considered possibly or probably related to the combined administration of dolutegravir plus rilpivirine in 513 HIV-1 infected subjects in the Phase III clinical trials (see section 5.1), were diarrhoea (2%) and headache (2%).
Najpogostejša neželena učinka, ki veljata za morda ali verjetno povezana s kombinirano uporabo dolutegravirja in rilpivirina pri 513 s HIV-1 okuženih osebah kliničnih preskušanjih faze III (glejte poglavje 5.1), sta bila driska (2 %) in glavobol
Animal studies with dolutegravir or rilpivirine do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Študije z dolutegravirjem ali rilpivirinom na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov glede reproduktivne toksičnosti (glejte poglavje 5.3).
Pink, oval, biconvex tablets, approximately 14 x 7 mm, debossed with ‘SV J3T' on one side.
Rožnate, ovalne, bikonveksne tablete, velike približno 14 x 7 mm in z vtisnjeno oznako "SV J3T" na eni strani.
Juluca should not be administered with other antiretroviral medicinal products for the treatment of HIV (see section 4.5).
Zdravila Juluca se ne sme vzeti z drugimi protiretrovirusnimi zdravili za zdravljenje okužbe s HIV (glejte poglavje 4.5).
Juluca must be taken orally, once daily with a meal (see section 5.2).
Peroralna uporaba Zdravilo Juluca je treba jemati peroralno, enkrat na dan, z obrokom (glejte poglavje 5.2).
Dolutegravir and rilpivirine are both primarily metabolized and eliminated by the liver.
Dolutegravir in rilpivirin se oba v primarno presnovljata in odstranita v jetrih.
When mutations listed as secondary integrase inhibitor associated mutations (for raltegravir/elvitegravir) are added to primary mutations (excluding at Q148) in experiments with site directed mutants, dolutegravir susceptibility remains at or near wildtype level.
Če so mutacije, navedene kot sekundarne mutacije povezane z zaviralci integraze (za raltegravir/elvitegravir), v poskusih s točkovnimi mutanti dodali primarnim mutacijam (razen Q148), je občutljivost za dolutegravir ostala takšna ali skoraj takšna kot pri divjem tipu.
The effect of Juluca on human pregnancy is unknown.
Vpliv zdravila Juluca na nosečnost pri človeku ni znan.
Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine.
Odpornost proti rilpivirinu je bila ohranjena (FC ≤ BCO) pri 62 % od 4786 rekombinantnih kliničnih izolatih HIV-1, odpornih proti efavirenzu in/ali nevirapinu.
Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
urinu so nespremenjeni rilpivirin ugotovili le v sledeh (< 1 % odmerka).
In a rilpivirine study comparing 8 patients with mild hepatic impairment (Child-Pugh score A) to 8 matched controls, and 8 patients with moderate hepatic impairment (Child-Pugh score B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
V študiji, v kateri so primerjali 8 bolnikov z blago okvaro jeter (Child-Pugh A) z 8 ujemajočimi kontrolnimi osebami ter 8 bolnikov z zmerno okvaro jeter (Child-Pugh B) z 8 ujemajočimi kontrolnimi osebami, je bila izpostavljenost rilpivirinu po večkratnih odmerkih pri bolnikih z blago okvaro jeter 47 % večja in pri tistih z zmerno okvaro 5 % večja.
Effect of other medicinal products on the pharmacokinetics of dolutegravir and rilpivirine
Vpliv drugih zdravil na farmakokinetiko dolutegravirja in rilpivirina
Thirty-two percent of the total oral dose is excreted in the urine, mainly represented by ether glucuronide of dolutegravir (18.9% of total dose), N-dealkylation metabolite (3.6% of total dose), and a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose).
Dvaintrideset odstotkov celotnega peroralnega odmerka se izloči v urinu, v glavnem v obliki dolutegravirjevega glukuronida (18,9 % celotnega odmerka), N-dealkilacijskega presnovka (3,6 % celotnega odmerka) in presnovka, nastalega z oksidacijo na benzilnem ogljiku (3,0 % celotnega odmerka).
Liver problems including hepatitis B and/or C
Težave z jetri, vključno s hepatitisom B in/ali C
The absolute bioavailability of dolutegravir or rilpivirine has not been established.
Absolutna biološka uporabnost dolutegravirja ali rilpivirina nista ugotovljeni.
No data are available in subjects receiving dialysis although differences in pharmacokinetics are not expected in this population (see section 5.2).
Za bolnike, ki se zdravijo z dializo, ni podatkov, vendar v tej populaciji ni pričakovati razlik v farmakokinetiki (glejte poglavje 5.2).
There are no data on the effects of dolutegravir or rilpivirine on human male or female fertility.
Podatkov o vplivu dolutegravirja ali rilpivirina na plodnost moških in žensk pri človeku ni.
The combination of Juluca and artemether/lumefantrine should be used with caution.
Kombinacijo zdravila Juluca in artemetra/lumefantrina je treba uporabljati previdno.
However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate hepatic impairment.
Vendar pa ni mogoče izključiti možnosti, da je izpostavljenost farmakološko aktivnemu nevezanemu rilpivirinu pri bolnikih z zmerno okvaro jeter bistveno povečana.
Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Rilpivirin v priporočenem odmerku 25 mg enkrat na dan nima klinično pomembnega vpliva na interval QTc.
No mother to child transmission occurred in all 10 infants born to the mothers who completed the trial and for whom the HIV status was available.
Pri nobenem od 10 otrok, rojenih materam, ki so dokončale preskušanje in za katere je bilo znano stanje HIV, ni prišlo do prenosa virusa z matere na otroka.
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 bil aktiven proti laboratorijskim sevom divjega tipa HIV-1 v akutno okuženi liniji celic T z mediano vrednostjo IC50 za HIV-1/IIIB 0,73 nM (0,27 ng/ml).
In contrast, starting passage with mutants with mutation Q148H (FC 1), a variety of raltegravir associated secondary mutations accumulated with a consequent increase of FC to values >10.
V nasprotju s tem so se po začetku prehoda z mutanti z mutacijo Q148H (FC 1) nakopičile različne mutacije, povezane z raltegravirjem, s posledičnim povečanjem FC > 10.
Dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OAT3.
Dolutegravir lahko poveča plazemsko koncentracijo zdravil, katerih izločanje je odvisno od OAT3.
Rilpivirine 25 mg once daily is not likely to have a clinically relevant effect on the exposure of medicinal products metabolised by CYP enzymes.
Ni verjetno, da bi rilpivirin v odmerku 25 mg enkrat na dan klinično pomembno vplival na izpostavljenost zdravilom, ki jih presnavljajo encimi CYP.
Combinations of multiple substitutions T66K/L74M, E92Q/N155H, G140C/Q148R, G140S/Q148H, R or K, Q148R/N155H, T97A/G140S/Q148, and substitutions at
Kombinacije več substitucij T66K/L74M, E92Q/N155H, G140C/Q148R, G140S/Q148H, R ali K, Q148R/N155H, T97A/G140S/Q148 in substitucije na E138/G140/Q148 so povzročile več kot 2
Rilpivirine is a diarylpyrimidine non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1.
Rilpivirin je diarilpirimidinski nenukleozidni zaviralec reverzne transkriptaze (NNRTI) HIV-1.
The film-coated tablets are provided in bottles closed with child-resistant closures.
Filmsko obložene tablete so na voljo v plastenkah, zaprtih z zaporko, varno za otroke.
Subjects were enrolled if they were on their first or second antiretroviral regimen with no history of virological failure, had no suspected or known resistance to any antiretroviral and had been stably suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months prior to screening.
Preiskovanci so bili vključeni, če so se zdravili s prvo ali drugo protiretrovirusno shemo, v anamnezi niso imeli virološkega neuspeha, niso imeli domnevne ali znane odpornosti proti kateremu koli protiretrovirusnemu zdravilu in s stabilno virološko supresijo (HIV-1 RNA < 50 kopij/ml) vsaj 6 mesecev pred presejanjem.
There are limited data available on the use of Juluca in patients aged 65 years and over.
Podatkov o uporabi zdravila Juluca pri bolnikih, starih 65 let ali več, je malo.
A study of the pharmacokinetics of dolutegravir was performed in subjects with severe renal impairment (CLcr <30 mL/min) and matched healthy controls.
Študijo farmakokinetike dolutegravirja so izvedli pri preiskovancih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) in pri ujemajočih se zdravih kontrolnih osebah.
In 100% human serum, the dolutegravir mean protein fold shift was 75 fold, resulting in protein adjusted IC90 of 0.064 µg/mL.
V 100-odstotnem humanem serumu je bil povprečni zasuk beljakovine (protein fold shift) za dolutegravir 75, tako da je bila za beljakovine korigirana IC90 0,064 µg/ml.
• itching (pruritus)
• srbenje (pruritus),