FrancophonIA/ELRC3.0 huggingface dataset:
English: Interactions between dolutegravir and co-administered medicinal products are listed in Table 2 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”, concentration at end of dosing interval as “Cτ”).
Slovenian: Interakcije med dolutegravirjem in sočasno uporabljenimi zdravili so navedene v Preglednici 2 (zvečanje je označeno kot “↑”, zmanjšanje kot “↓”, brez spremembe kot “↔”, površina pod koncentracijsko krivuljo v odvisnosti od časa kot “AUC”, maksimalna zabeležena koncentracija kot “Cmax”, koncentracija na koncu odmernega intervala pa kot “Cτ”).
English: Baseline CD4+ (cells/ mm3) 200 to <350 NRTI backbone ABC/3TC
Slovenian: CD4+ (celic/mm3) 200 do < 350 NRTI ABC/3TC
English: 30 to less than 40
Slovenian: 30 do manj kot 40
English: Median Change from Baseline, cells/mm3
Slovenian: Mediana sprememba od izhodišča, celic/mm3
English: When excluding patients who stopped therapy for non-efficacy reasons, and those with major protocol deviations (incorrect dolutegravir dosing, intake of prohibited co-medication), namely, “the Virological Outcome (VO)-population)”, the corresponding response rates were 75% (120/161, week 24) and 69% (111/160, week 48).
Slovenian: Z izključenimi bolniki, ki so končali zdravljenje zaradi neučinkovitosti ali so imeli večje kršitve protokola (nepravilno odmerjanje dolutegravirja, sočasno jemanje prepovedanih zdravil), "populacija z virološkim odzivom (VO)", sta bila ustrezna deleža odziva 75 % (120/161, 24. teden) in 69 % (111/160, 48. teden).
English: In animal reproductive toxicity studies, no adverse development outcomes, including neural tube defects, were identified (see section 5.3).
Slovenian: V študijah toksičnosti za razmnoževanje pri živalih niso bili ugotovljeni negativni učinki na razvoj, vključno z okvarami nevralne cevi (glejte poglavje 5.3).
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, Pgp, and BCRP; therefore medicinal products that induce those enzymes may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 2).
Slovenian: UGT1A9, CYP 3A4, Pgp in BCRP, zato lahko zdravila, ki inducirajo te encime, znižajo plazemske koncentracije dolutegravirja in zmanjšajo njegov terapevtski učinek (glejte Preglednico 2).
English: If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Slovenian: Če je čas do naslednjega odmerka do 4 ure, bolnik ne sme vzeti pozabljenega odmerka, ampak preprosto nadaljuje z jemanjem po ustaljenem urniku.
English: But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time.
Slovenian: Če pa je čas do naslednjega odmerka do 4 ure, izpustite pozabljeni odmerek in vzemite naslednjega ob običajnem času.
English: The absolute bioavailability of dolutegravir has not been established.
Slovenian: Absolutna biološka uporabnost dolutegravirja ni ugotovljena.
English: • The usual dose is one 50 mg tablet once a day.
Slovenian: • Običajni odmerek je ena 50 mg tableta enkrat na dan.
English: Symptoms usually include fever, plus some of the following:
Slovenian: Simptomi običajno vključujejo povišano telesno temperaturo in še katerega od naslednjih: • glavobol
English: Pharmacokinetic data for dolutegravir in subjects >65 years of age are limited.
Slovenian: Farmakokinetičnih podatki o dolutegravirju pri osebah starejših od 65 let so omejeni.
English: Like all medicines, this medicine can cause side effects, but not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa zdravila, ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: HDPE (high density polyethylene) bottles closed with child resistant polypropylene screw closures, with a polyethylene faced induction heat seal liner.
Slovenian: Vsebniki iz HDPE (polietilena visoke gostote) zaprti z za otroke varnimi polipropilenskimi pokrovčki z navojem, zapečateni s polietilensko folijo s pomočjo toplotne indukcije.
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 citokrom P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, uridin difosfat glukuronozil transferazo (UGT)1A1 ali UGT2B7, ali na prenašalce Pgp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 ali MRP4.
English: Dolutegravir pharmacokinetics are similar between healthy and HIV-infected subjects.
Slovenian: Farmakokinetika dolutegravirja je podobna pri zdravih osebah in osebah, okuženih z virusom HIV.
English: 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).
Slovenian: Na podlagi teh podatkov ni pričakovati, da bi dolutegravir vplival na farmakokinetiko zdravil, ki so substrati glavnih encimov ali prenašalci (glejte poglavje 4.5).
English: The most severe adverse reaction, seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4).
Slovenian: Najresnejši neželeni učinek, ki je bil opažen pri posameznem bolniku, je bila preobčutljivostna reakcija z izpuščajem in hudo prizadetostjo jeter (glejte poglavje 4.4).
English: In Phase III studies patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN).
Slovenian: V študijah faze III so bolniki s sočasno okužbo z virusom hepatitisa B in/ali C smeli biti vključeni v raziskavo pod pogojem, da njihove izhodiščne vrednosti jetrnih testov niso presegle petkratne zgornje meje normale (ULN - upper limit of normal).
English: Five further subjects experienced PDVF between weeks 24 and 48, and 2 of these 5 had treatment emergent mutations.
Slovenian: Petim dodatnim preiskovancem se je po protokolu opredeljen virološki neuspeh pojavil od 24. do 48. tedna; 2 od teh 5 bolnikov sta imela mutacije, ki so se pojavile med zdravljenjem.
English: The response was lower when the Q148-mutation was present at baseline, and in particular in the presence of ≥2 secondary mutations, Table 8.
Slovenian: Odziv je bil manjši, kadar je bila ob izhodišču prisotna mutacija Q148, še posebej ob prisotnosti ≥
English: Dolutegravir has a less than or equal to 10 FC against 94% of the 705 clinical isolates.
Slovenian: Dolutegravir ima ≤10 FC proti 94% 705 kliničnih izolatov.
English: Then continue your treatment as before.
Slovenian: Nadaljujte z zdravljenjem tako,
English: In a juvenile toxicity study in rats, dolutegravir administration resulted in two preweanling deaths at 75 mg/kg/day.
Slovenian: V študiji juvenilne toksičnosti pri podganah je smrt dveh mladičev pred odstavitvijo povzročila uporaba dolutegravirja v odmerku 75 mg/kg/dan.
English: • difficulty moving.
Slovenian: • oteženo gibanje
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji,
English: 20 to less than 30
Slovenian: 20 do manj kot 30
English: Other medicines and Tivicay Tell your doctor if you are taking, have recently taken or are planning to take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: PK/PD modelling using pooled data from clinical studies in integrase resistant patients suggest that increasing the dose from 50 mg twice daily to 100 mg twice daily may increase the effectiveness of dolutegravir in patients with integrase resistance and limited treatment options due to advanced multi class resistance.
Slovenian: Farmakokinetično/farmakodinamično modeliranje z uporabo skupnih podatkov kliničnih študij pri bolnikih, odpornih na zaviralce integraze, kaže, da lahko povečanje odmerka s 50 mg dvakrat na dan na 100 mg dvakrat na dan poveča učinkovitost dolutegravirja pri bolnikih z odpornostjo proti zaviralcem integraze in omejenimi možnostmi zdravljenja zaradi napredovale odpornosti proti več skupinam.
English: The results of the pooled analysis were in line with those of the individual studies, for which the primary endpoint (difference in proportion <50 copies/mL plasma HIV-1 RNA at week 48 based on the Snapshot algorithm) was met.
Slovenian: Rezultati združene analize so bili v skladu z rezultati vsake posamezne študije, za katere je bil primarni cilj (razlika v deležu < 50 kopij/mL HIV-1 RNA v plazmi po 48 tednih glede na “snapshot” algoritem) dosežen.
English: The adverse reactions considered at least possibly related to dolutegravir are listed by body system, organ class and absolute frequency.
Slovenian: Neželeni učinki, ki bi lahko bili vsaj domnevno povezani z dolutegravirjem, so navedeni glede na prizadeti organski sistem in pogostnost.
English: Vistor hf. Sími: + 354 535 7000
Slovenian: Sími: + 354 535 7000
English: Dolutegravir and dofetilide co-administration is contraindicated due to potential life-threatening toxicity caused by high dofetilide concentration (see section 4.3).
Slovenian: Sočasna uporaba dolutegravirja in dofetilida je kontraindicirana zaradi možne življenjsko nevarne toksičnosti, ki jo povzroča visoka koncentracija dofetilida (glejte poglavje 4.3).
English: In the rat pre/post-natal development study, decreased body weight of the developing offspring was observed during lactation at a maternally toxic dose (approximately 27 times human exposure at the maximum recommended human dose).
Slovenian: V študiji pre- in postnatalnega razvoja pri podganah so opažali zmanjšanje telesne mase razvijajočih se mladičev v obdobju dojenja med uporabo odmerka, toksičnega za samice-matere (približno 27-kratna izpostavljenost pri človeku med uporabo največjega priporočenega odmerka za človeka).
English: If the patient misses a dose of Tivicay, the patient should take Tivicay as soon as possible, providing the next dose is not due within 4 hours.
Slovenian: Izpuščeni odmerki Če bolnik izpusti odmerek zdravila Tivicay, ga mora vzeti čim prej, pod pogojem, da do naslednjega odmerka ni manj kot 4 ure.
English: No data are available in subjects receiving dialysis although differences in pharmacokinetics are not expected in this population (see section 5.2).
Slovenian: Za bolnike, ki se zdravijo z dializo, ni podatkov, vendar pri tej populaciji ni pričakovati razlik v farmakokinetiki (glejte poglavje 5.2).
English: What Tivicay looks like and contents of the pack
Slovenian: Izgled zdravila Tivicay in vsebina pakiranja
English: The efficacy of dolutegravir in HIV-infected, therapy naïve subjects is based on the analyses of 96-week data from two randomized, international, double-blind, active-controlled trials, SPRING-2 (ING113086) and SINGLE (ING114467).
Slovenian: Učinkovitost dolutegravirja pri predhodno nezdravljenih osebah, okuženih z virusom HIV, temelji na analizi 96-tedenskih podatkov iz dveh randomiziranih, mednarodnih, dvojno slepih, aktivno nadzorovanih študij: SPRING-2 (ING113086) in SINGLE (ING114467).
English: The efficacy of dolutegravir in combination with lamivudine in adults is supported by 48-week primary endpoint data from two identical 148-week, randomised, multicentre, double-blind, non-inferiority studies GEMINI-1 (204861) and GEMINI-2 (205543).
Slovenian: Učinkovitost dolutegravirja v kombinaciji z lamivudinom pri odraslih osebah temelji na 48 tedenskih podatkih o primarnih izidih iz dveh identičnih 148 tednov trajajočih randomiziranih, multicentričnih, dvojno slepih, neinferiornih študij GEMINI-1 (204861) in GEMINI-2 (205543).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: In a combined analysis of VIKING-3 and VIKING-4 (n=186, VO population), the proportion of subjects with HIV RNA <50 copies/mL at Week 48 was 123/186 (66%).
Slovenian: V kombinirani analizi študij VIKING-3 in VIKING-4 (n = 186, populacija z VO) je bil delež preiskovancev s HIV RNA < 50 kopij/ml v 48. tednu 123/186 (66 %).
English: Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age.
Slovenian: Zdravilo Tivicay je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih, mladostnikov in otrok, starejših od 6 let, okuženih z virusom humane imunske pomanjkljivosti (HIV).
English: The proportion of subjects with HIV RNA <50 copies/mL was 96/126 (76%) for No Q148 mutations, 22/41 (54%) for Q148+1 and 5/19 (26%) for Q148+≥2 secondary mutations.
Slovenian: Delež preiskovancev s HIV RNA < 50 kopij/ml je bil 96/126 (76 %) za tiste brez mutacij Q148, 22/41 (54 %) za tiste s Q148+1 in 5/19 (26 %) za tiste s Q148+≥ 2 sekundarnima mutacijama.
English: For the comparator arms, the same lack of treatment emergent resistance was also the case for patients treated with darunavir/r in FLAMINGO.
Slovenian: V primerjalnih skupinah prav tako ni bilo primerov med zdravljenjem nastale odpornosti pri bolnikih, zdravljenih s kombinacijo darunavir/r v študiji FLAMINGO.
English: Median CD4 change from baseline * Adjusted for baseline stratification factors.
Slovenian: Srednji odklon CD4 od izhodišča * Prilagojeno za izhodiščne dejavnike stratifikacije.
English: Antidiabetics Metformin
Slovenian: Antidiabetiki metformin metformin ↑
English: Do not remove the desiccant.
Slovenian: Ne odstranjujte sušilnega sredstva.
English: The decision to use dolutegravir for such patients should be informed by the integrase resistance pattern (see section 5.1).
Slovenian: Odločitev za uporabo dolutegravirja pri takšnih bolnikih mora temeljiti na podatkih o odpornosti na zaviralce integraze (glejte poglavje 5.1).
English: HIV-1 RNA <50 copies/mL at 24 weeks, n (%) HIV-1 RNA <50 copies/mL at 48 weeks, n (%) HIV-1 RNA <400 copies/mL at 24 weeks, n (%) HIV-1 RNA <400 copies/mL at 48 weeks, n (%) Virologic non response
Slovenian: HIV-1 RNA < 50 kopij/ml po 24 tednih, n (%) HIV-1 RNA < 50 kopij/ml po 48 tednih, n (%) HIV-1 RNA < 400 kopij/ml po 24 tednih, n (%) HIV-1 RNA < 400 kopij/ml po 48 tednih, n (%) Virološki neodziv
English: The bottles contain 30 or 90 film-coated tablets.
Slovenian: Vsebniki vsebujejo 30 ali 90 filmsko obloženih tablet.
English: Alternatives to carbamazepine should be used where possible for INI resistant patients.
Slovenian: Če je mogoče, je treba pri bolnikih, odpornih proti zaviralcem integraze, uporabiti alternative karbamazepinu.
English: GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Slovenian: Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
English: Virologic non-response†
Slovenian: Virološki neodziv†
English: Although these simulated results have not been confirmed in clinical trials, this high dose may be considered in the presence of the Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I in patients with overall limited treatment options due to advanced multi class resistance.
Slovenian: Čeprav ti simulirani rezultati niso bili potrjeni v kliničnih preskušanjih, ta visoki odmerek morda lahko pride v poštev v prisotnosti Q148 + ≥ 2 sekundarnih mutacij G140A/C/S, E138A/K/T, L74I pri bolnikih, ki imajo v celoti omejene možnosti zdravljenja zaradi napredovale odpornosti proti več skupinam.
English: At 96 weeks, virologic suppression in the dolutegravir group (80%) was superior to the DRV/r group (68%), (adjusted treatment difference [DTG-(DRV+RTV)]: 12.4%; 95% CI: [4.7, 20.2].
Slovenian: Po 96 tednih je bila virološka supresija v skupini z dolutegravirjem (80 %) superiorna tisti v skupini z DRV/r (68 %) (korigirana razlika med zdravljenjema [DTG(DRV+RTV)]: 12,4 %, 95 % IZ: [4,7; 20,2].
English: The apparent oral clearance (CL/F) is approximately 1L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Slovenian: Navidezni peroralni očistek (CL/F) pri bolnikih, okuženih s HIV, je na podlagi populacijske farmakokinetične analize približno 1 l/uro.
English: In 100% human serum, the mean protein fold shift was 75 fold, resulting in protein adjusted IC90 of 0.064 µg/mL.
Slovenian: V 100% humanem serumu je bil povprečni zasuk proteinskega zavoja 75-kraten, zaradi česar je bil IC90
English: Etravirine without boosted protease inhibitors decreased plasma dolutegravir concentration.
Slovenian: Etravirin brez okrepljenih zaviralcev proteaz je znižal plazemsko koncentracijo dolutegravirja.
English: The film-coated tablets are provided in bottles containing 30 or 90 tablets.
Slovenian: Filmsko obložene tablete so na voljo v vsebnikih, ki vsebujejo po 30 ali 90 filmsko obloženih tablet.
English: Dofetilide ↑ (Not studied, potential increase via inhibition of OCT2 transporter)
Slovenian: Druga zdravila Antiaritmiki dofetilid dofetilid ↑ (Ni raziskano; morebitno povišanje preko zaviranja prenašalca OCT2)
English: Metformin is eliminated renally and, therefore, it is of importance to monitor renal function when co-treated with dolutegravir.
Slovenian: Metformin se izloča skozi ledvice, zato je med sočasnim zdravljenjem z dolutegravirjem pomembno kontrolirati delovanje ledvic.
English: Dose recommendations according to weight are presented in table 1.
Slovenian: Priporočila za odmerjanje glede na telesno maso so prikazana v Preglednici 1.
English: 8%b a 22 subjects contributed Week 48 CD4+ cell count data b 21 subjects contributed Week 24 CD4+ cell count data
Slovenian: 8 %b a Podatki o številu celic CD4+ 48. teden izvirajo od 22 preiskovancev b Podatki o številu celic CD4+ 24. teden izvirajo od 21 preiskovancev
English: b Confirmed plasma HIV-1 RNA levels to ≥200 cps/mL after prior confirmed suppression to <200 cps/mL.
Slovenian: b Potrjene vrednosti HIV-1 RNA v plazmi na ≥200 kopij/mL po predhodno potrjeni supresiji na <200 kopij/mL.
English: → Don't take a double dose to make up for a missed dose.
Slovenian: → Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: The specific dosage recommendation for the 10 mg tablet, as specified in Table 1, should be followed.
Slovenian: Za 10 mg tablete, je potrebno upoštevati specifična priporočila za odmerjanje, ki so navedena v Preglednici 1.
English: In patients with moderate renal impairment a dose adjustment of metformin should be considered when coadministered with dolutegravir, because of the increased risk for lactic acidosis in patients with moderate renal impairment due to increased metformin concentration (section 4.4).
Slovenian: Pri bolnikih z zmerno okvaro ledvic je treba v primeru sočasne uporabe z dolutegravirjem razmisliti o prilagoditvi odmerka metformina, ker imajo bolniki z zmerno okvaro ledvic zaradi večje koncentracije metformina večje tveganje za laktacidozo (glejte poglavje 4.4).
English: Tivicay can make you dizzy and have other side effects that make you less alert.
Slovenian: Zdravilo Tivicay vam lahko povzroči omotico in ima druge neželene učinke, ki lahko zmanjšajo zbranost.
English: Treatment emergent integrase resistance typically appeared in patients with a history of the Q148-mutation (baseline or historic).
Slovenian: Z zdravljenjem povezana odpornost na integrazo se je značilno pojavila pri bolnikih, ki so že imeli mutacijo Q148 (izhodiščno ali preteklo).
English: Calcium supplements, iron supplements or multivitamins Calcium supplements, iron supplements or multivitamins can stop Tivicay being absorbed into your body and make it less effective.
Slovenian: Kalcijevi dodatki, železovi dodatki ali multivitaminski pripravki lahko preprečijo absorpcijo zdravila Tivicay v telo in povzročijo, da je zdravilo manj učinkovito.
English: In the presence of documented resistance that includes Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I, modelling suggests that an increased dose may be considered for patients with limited treatment options (less than 2 active agents) due to advanced multi class resistance (see section 5.2).
Slovenian: V primeru dokumentirane odpornosti, ki vključuje Q148 + ≥ 2 sekundarni mutaciji G140A/C/S, E138A/K/T, L74I, modeliranje kaže, da je mogoče razmisliti o povečanju odmerka pri bolnikih z omejenimi možnostmi zdravljenja (manj kot 2 aktivni učinkovini) zaradi napredovale odpornosti proti več skupinam (glejte poglavje 5.2).
English: - The other ingredients are mannitol (E421), microcrystalline cellulose, povidone (K29/32), sodium starch glycolate, sodium stearyl fumarate, polyvinyl alcohol-partially hydrolyzed, titanium dioxide (E171), macrogol, talc and for 25 and 50 mg tablets, iron oxide yellow (E172).
Slovenian: - Druge sestavine so manitol (E421), mikrokristalna celuloza, povidon (K29/32), natrijev karboksimetilškrob, natrijev stearil fumarat, polivinil alkohol (delno hidroliziran), titanov dioksid (E171), makrogol, smukec in za 25 mg ter 50 mg tablete, rumeni železov oksid (E172).
English: Animal studies indicate no effects of dolutegravir on male or female fertility (see section 5.3).
Slovenian: Raziskave na živalih kažejo, da dolutegravir ne vpliva na moško ali žensko plodnost (glejte poglavje 5.3).
English: The two-drug regimen of dolutegravir 50 mg once daily and lamivudine 300 mg once daily was explored in two large randomized and blinded studies, GEMINI 1 and GEMINI 2 (see section 5.1).
Slovenian: Zdravljenje s shemo z dvema učinkovinama, 50 mg dolutegravirja in 300 mg lamivudina, enkrat na dan so preučevali v dveh obsežnih, randomiziranih, dvojno slepih študijah GEMINI 1 in GEMINI 2 (glejte poglavje 5.1).
English: ≤100,000 cps/mL
Slovenian: ≤100,000 kopij/mL
English: In SPRING-2, dolutegravir was still noninferior to raltegravir (viral suppression in 81% vs 76% of patients), and with a median change in CD4 count of 276 vs 264 cells/mm3, respectively.
Slovenian: V študiji SPRING-2 je bil dolutegravir še vedno neinferioren raltegravirju (supresija virusov pri 81 % bolnikih v primerjavi s 76 %), mediana sprememba števila celic CD4 pa je bila 276 v primerjavi z 264 celic/mm3.
English: The 50 mg dose should be taken as a single 50 mg tablet.
Slovenian: Odmerek 50 mg je treba vzeti kot eno 50 mg tableto.
English: 25 mg once daily
Slovenian: 25 mg enkrat na dan
English: The safety and efficacy of dolutegravir in children aged less than 6 years or weighing less than 15 kg have not yet been established.
Slovenian: Varnost in učinkovitost dolutegravirja pri otrocih, mlajših od 6 let ali s telesno maso pod 15 kg, še nista bili dokazani.
English: There are limited data on subjects with hepatitis B co-infection.
Slovenian: Podatki o sočasni okužbi s hepatitisom B so omejeni.
English: In vitro, dolutegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
Slovenian: Dolutegravir ni induciral CYP1A2, CYP2B6 ali CYP3A4
English: The exposure to dolutegravir was decreased by approximately 40% in subjects with severe renal impairment.
Slovenian: Pri osebah s hudo okvaro ledvic je bila izpostavljenost dolutegravirju zmanjšana za približno 40 %.
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 I. faze pri zdravih preiskovancih je bil interindividualni CVb% AUC in Cmax med študijami od ~20 do 40 % in Cτ od 30 do