FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of Juluca with medicinal products that induce CYP3A may result in decreased plasma concentrations of rilpivirine, which could reduce the therapeutic effect of Juluca (see Table 1).
Slovenian: Sočasna uporaba zdravila Juluca z zdravili, ki inducirajo CYP3A, lahko zmanjša koncentracijo rilpivirina v plazmi, to pa lahko zmanjša terapevtski učinek zdravila Juluca (glejte Preglednico 1).
English: When Juluca is co-administered with rifabutin, an additional 25 mg tablet of rilpivirine per day should be taken at the same time with Juluca, for the duration of the rifabutin co-administration (a separate formulation of rilpivirine is available for this dose adjustment, see section 4.2).
Slovenian: Med sočasno uporabo zdravila Juluca z rifabutinom, mora bolnik med obdobjem jemanja rifabutina dodatno jemati še 25-mg tableto rilpivirina na dan (za to prilagoditev odmerka je na voljo ločena farmacevtska oblika rilpivirina, glejte poglavje rifabutin/rilpivirin1 300 mg enkrat na dan2
English: Signs of osteonecrosis include:
Slovenian: Med znaki osteonekroze so: • okorelost sklepov,
English: In women receiving rilpivirine 25 mg once daily during the 2nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were, respectively, 21%, 29% and 35% lower as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 20%, 31% and 42% lower as compared to postpartum (see sections 4.2, 4.4. and 4.6).
Slovenian: Med uporabo 25 mg rilpivirina enkrat na dan so bile povprečne intraindividualne vrednosti Cmax, AUC24h oziroma Cmin celokupnega rilpivirina v drugem trimesečju nosečnosti 21 %, 29 % oziroma 35 % manjše, v tretjem trimesečju pa 20 %, 31 % oziroma 42 % manjše kot v obdobju po porodu (glejte poglavja 4.2, 4.4 in 4.6).
English: In limited data from small numbers of women in study IMPAACT P1026 who received dolutegravir 50 mg once daily during the 2nd trimester of pregnancy, mean intra-individual values for total dolutegravir Cmax, AUC24h and C24h values were, respectively, 26%, 37% and 51% lower as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 25%, 29% and 34% lower as compared to postpartum (see sections 4.2, 4.4. and 4.6).
Slovenian: 2. trimesečju nosečnosti prejemale 50 mg dolutegravirja enkrat na dan, so bile povprečne intraindividualne celotne vrednosti Cmax, AUC24h oziroma C24h dolutegravirja za 26 %, 37 % oziroma 51 % nižje kot po porodu; v 3. trimesečju nosečnosti so bile vrednosti Cmax, AUC24h oziroma C24h za 25 %, 29 % oziroma 34 % nižje kot po porodu (glejte poglavja 4.2, 4.4 in 4.6).
English: Lower exposures of dolutegravir and rilpivirine were observed during pregnancy.
Slovenian: Med nosečnostjo so opažali manjšo izpostavljenost dolutegravirju in rilpivirinu.
English: The clinical status of the patient and the adverse reaction profile of Juluca should be borne in mind when considering the patient's ability to drive or operate machinery.
Slovenian: Pri presojanju bolnikove sposobnosti za vožnjo in upravljanje strojev je treba upoštevati bolnikovo klinično stanje in značilnosti neželenih učinkov zdravila Juluca.
English: Metformin/ Rilpivirine1
Slovenian: metformin/ rilpivirin1
English: Macrolide antibiotics Clarithromycin Erythromycin /Dolutegravir
Slovenian: Makrolidni antibiotiki klaritromicin eritromicin /dolutegravir dolutegravir ↔ (Ni raziskano)
English: • increase in lipase (an enzyme involved in breaking down fats)
Slovenian: • zvišanje trigliceridov (vrsta maščob), • zvišanje lipaze (encim, ki je vključen v razgradnjo maščob),
English: Co-administration of Juluca with medicinal products that inhibit CYP3A may result in increased plasma concentrations of rilpivirine (see Table 1).
Slovenian: Sočasna uporaba zdravila Juluca z zdravili, ki zavirajo CYP3A, lahko poveča koncentracijo rilpivirina v plazmi (glejte Preglednico 1).
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of Juluca with metformin, to maintain glycaemic control.
Slovenian: Juluca z metforminom je treba razmisliti o prilagoditvi odmerka metformina, da bi ohranili urejenost glikemije.
English: If calcium supplements, iron supplements or multivitamins cannot be taken at the same time as Juluca, these supplements should be taken well separated in time from the administration of Juluca (minimum 6 hours before or 4 hours after).
Slovenian: Če dodatkov kalcija, dodatkov železa ali multivitaminskih pripravkov ni mogoče vzeti sočasno z zdravilom Juluca, jih je priporočljivo vzeti s precejšnjim časovnim odmikom od zdravila Juluca (vsaj 6 ur pred njim ali 4 ure po njem).
English: A dose adjustment of metformin should be considered when starting and stopping co-administration of Juluca with metformin, to maintain glycaemic control (see section 4.5).
Slovenian: Juluca z metforminom je treba razmisliti o prilagoditvi odmerka metformina, da bi ohranili urejenost glikemije (glejte poglavje 4.5).
English: Co-administration of Juluca with systemic dexamethasone is contraindicated (except as a single dose) see section 4.3.
Slovenian: Sočasna uporaba zdravila Juluca s sistemsko uporabljenim deksametazonom je kontraindicirana (razen v primeru uporabe enkratnih odmerkov), glejte poglavje 4.3.
English: No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh score A or B).
Slovenian: Bolnikom z blago ali zmerno okvaro jeter (Child-Pugh A ali B) odmerka ni treba prilagoditi.
English: These may affect up to 1 in 10 people:
Slovenian: Pojavijo se lahko pri največ 1 do 1000 bolnikov:
English: If you can't take these supplements at the same time as Juluca, do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Juluca, or for at least 4 hours after you take it (see also section 3, ‘How to take Juluca')
Slovenian: Če teh dodatkov ne morete vzeti hkrati z zdravilom Juluca, ne jemljite dodatkov kalcija, dodatkov železa ali multivitaminskih pripravkov manj kot 6 ur preden vzamete zdravilo Juluca in še vsaj 4 ure po tem, ko ste vzeli to zdravilo (glejte tudi poglavje 3, "Kako jemati zdravilo Juluca"),
English: 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).
Slovenian: 300 mg enkrat na dan v stanju dinamičnega ravnovesja je bila povprečna Cmax približno 2,6-krat oziroma 6,7-krat večja kot povprečna Cmax v stanju dinamičnega ravnovesja po uporabi priporočenega odmerka rilpivirina 25 mg enkrat na dan (glejte poglavje 4.4).
English: Lower exposures of dolutegravir or rilpivirine were observed when taken once daily, in combination with a background regimen, during pregnancy.
Slovenian: Med uporabo enkrat na dan, v kombinaciji z osnovno shemo, so med nosečnostjo opažali manjšo izpostavljenost dolutegravirju ali rilpivirinu.
English: If a patient vomits more than 4 hours after taking Juluca, the patient does not need to take another dose of Juluca until the next regularly scheduled dose.
Slovenian: Če bruha več kot 4 ure po zaužitju zdravila Juluca, pa mu ni treba vzeti dodatnega odmerka zdravila Juluca, temveč mora nadaljevati z naslednjim odmerkom po rednem urniku.
English: A mean change from baseline of 8.22 µmol/L (range -26.5 to 51.2 µmol/L) was observed after 48 weeks treatment.
Slovenian: Po 48 tednih zdravljenja so opažali povprečno spremembo za 8,22 µmol/l (razpon: od -26,5
English: → Talk to your doctor for further advice on taking rifabutin with Juluca.
Slovenian: → Posvetujte se z zdravnikom o dodatnih navodilih glede jemanja rifabutina skupaj z zdravilom
English: Immune system disorders uncommon hypersensitivity (see section 4.4) not known immune reconstitution syndrome
Slovenian: Bolezni imunskega sistema občasni preobčutljivost (glejte poglavje 4.4)
English: 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.
Slovenian: Primarni učinek dolutegravirja je bila pri podganah in opicah gastrointestinalna intoleranca ali draženje, in sicer ob odmerkih, pri katerih je bila sistemska izpostavljenost približno 30-kratnik
English: Decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected.
Slovenian: CYP3A; pričakovano je podobno zmanjšanje izpostavljenosti, kot je ugotovljeno s karbamazepinom.
English: The pharmacokinetics was evaluated in 11 children 6 to 12 years of age and showed that 25 mg once daily in patients weighing at least 20 kg and 35 mg once daily in patients weighing at least 30 kg resulted in dolutegravir exposure comparable to adults.
Slovenian: Ugotovili so, da sta odmerka 25 mg enkrat na dan pri bolnikih s telesno maso vsaj 20 kg ter 35 mg enkrat na dan pri bolnikih s telesno maso vsaj 30 kg povzročila izpostavljenost dolutegravirju, ki je bila podobna kot pri odraslih.
English: • increase in the level of liver enzymes (aminotransferases)
Slovenian: • zvišanje ravni jetrnih encimov (aminotransferaz), • zvišanje holesterola,
English: Significant decreases in rilpivirine plasma concentrations are expected.
Slovenian: Pričakovano je pomembno zmanjšanje koncentracije rilpivirina v plazmi.
English: Based on in vivo and/or in vitro data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of any major enzyme or transporter such as CYP3A4, CYP2C9 and P-gp (for more information see section 5.2).
Slovenian: Vpliv dolutegravirja in rilpivirina na farmakokinetiko drugih zdravil Na podlagi podatkov in vivo in/ali in vitro ni pričakovati, da bi dolutegravir vplival na farmakokinetiko zdravil, ki so substrati kakšnega pomembnega encima ali prenašalca kot so CYP3A4,
English: Therefore, use of Juluca during pregnancy is not recommended (see sections 4.6, 5.1 and 5.2).
Slovenian: Priporočil za prilagoditev odmerka za zdravilo Juluca med nosečnostjo ni mogoče dati, zato uporaba zdravila Juluca med nosečnostjo ni priporočljiva (glejte poglavja 4.6, 5.1 in 5.2).
English: Site-directed INI mutant virus
Slovenian: Proti INI odporni virusi s točkovno mutacijo
English: Juluca is bioequivalent to a dolutegravir 50 mg tablet and a rilpivirine 25 mg tablet administered together with a meal.
Slovenian: Zdravilo Juluca je bioekvivalentno 50-mg tableti dolutegravirja in 25-mg tableti rilpivirina, zaužitima z obrokom.
English: (Not studied, inhibition of CYP3A enzymes).
Slovenian: (Ni raziskano, zavrtje encimov CYP3A).
English: Rilpivirine ↔ AUC ↓ 5%
Slovenian: rilpivirin ↔ AUC ↓ 5 % Cmin ↓ 7 %
English: Limited data is available in patients with hepatitis C co-infection.
Slovenian: Podatkov o bolnikih, sočasno okuženih s hepatitisom C, je malo.
English: Dolutegravir ↔ Methadone ↔ AUC ↓ 2% Cmax ↔ 0% Cτ ↓ 1%
Slovenian: dolutegravir ↔ metadon ↔ AUC ↓ 2 % Cmax ↔ 0 % Cτ ↓ 1 %
English: Skin and subcutaneous tissue disorders common rash pruritus
Slovenian: Bolezni kože in podkožja pogosti izpuščaj srbenje
English: Co-administration of Juluca with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of Juluca.
Slovenian: Sočasna uporaba zdravila Juluca z zdravili, ki povišajo pH v želodcu, lahko zmanjša koncentracijo rilpivirina v plazmi, to pa lahko zmanjša terapevtski učinek zdravila Juluca.
English: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and to prevent fits) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis)
Slovenian: - karbamazepin, okskarbazepin, fenobarbital, fenitoin (zdravila za zdravljenje epilepsije in za preprečevanje napadov krčev),
English: There was no teratogenicity with rilpivirine in rats and rabbits.
Slovenian: Rilpivirin pri podganah in kuncih ni bil teratogen.
English: Do not take these medicines during the 12 hours before you take Juluca, or for at least 4 hours after you take it.
Slovenian: Teh zdravil ne jemljite vsaj 12 urapreden vzamete zdravilo Juluca ali še vsaj 4 ure po tem, ko vzamete zdravilo Juluca.
English: In reproductive toxicity studies in animals, dolutegravir was shown to cross the placenta.
Slovenian: Študije vpliva na sposobnost razmnoževanja pri živalih so pokazale, da dolutegravir prehaja skozi placento.
English: Co-administration may significantly decrease rilpivirine plasma concentration.
Slovenian: Sočasna uporaba lahko pomembno zmanjša koncentracijo rilpivirina v plazmi.
English: Juluca should be used with caution in patients with moderate hepatic impairment.
Slovenian: Pri bolnikih z zmerno okvaro jeter je treba zdravilo Juluca uporabljati previdno.
English: Juluca contains lactose
Slovenian: Zdravilo Juluca vsebuje laktozo
English: Clarithromycin Erythromycin /Rilpivirine
Slovenian: klaritromicin eritromicin /rilpivirin rilpivirin ↑
English: No dose adjustment is needed for patients with mild or moderate renal impairment.
Slovenian: Bolnikom z blago ali zmerno okvaro ledvic odmerka ni treba prilagoditi.
English: (induction of CYP3A enzymes).
Slovenian: (indukcija encimov CYP3A).
English: Fluconazole Itraconazole Isavuconazole Posaconazole Voriconazole/ Dolutegravir
Slovenian: flukonazol itrakonazol izavukonazol posakonazol vorikonazol/ dolutegravir flukonazol itrakonazol izavukonazol posakonazol vorikonazol/rilpivirin dolutegravir ↔ (Ni raziskano)
English: If you notice after 12 hours, then skip that dose and take the next doses as usual.
Slovenian: Če pa to, da ste pozabili vzeti zdravilo Juluca, ugotovite pozneje kot v 12 urah, preskočite tisti odmerek zdravila in vzemite naslednji odmerek kot po navadi.
English: (inhibition of intestinal P
Slovenian: (zavrtje črevesnega P-gp).
English: Do not take these medicines during the 12 hours before you take Juluca, or for at least 4 hours after you take it (see also section 3, ‘How to take Juluca')
Slovenian: Teh zdravil ne jemljite manj kot 12 ur preden vzamete zdravilo Juluca in vsaj še 4 ure po tem, ko ste vzeli zdravilo Juluca (glejte tudi poglavje 3, "Kako jemati zdravilo Juluca"),
English: R263K was reported from two individual patients with subtype B and subtype C in the Phase III clinical program for ART experienced, INI naive subjects, but without effects on dolutegravir susceptibility in vitro.
Slovenian: pri preiskovancih, ki so že prejemali protiretrovirusno zdravljenje, niso pa še prejemali INI, so pri dveh bolnikih s podtipom B in podtipom C poročali o R263K, toda brez vpliva na občutljivost za dolutegravir in vitro.
English: Dolutegravir ↔ AUC ↑ 33% Cmax ↑ 29% Cτ ↑ 45%
Slovenian: daklatasvir/ rilpivirin dolutegravir ↔ AUC ↑ 33 % Cmax ↑ 29 % Cτ ↑ 45 %
English: The combination of Juluca and antacids should be used with particular caution.
Slovenian: Kombinacijo zdravila Juluca in antacidov je treba uporabljati posebej previdno.
English: Magnesium stearate Microcrystalline cellulose Povidone (K29/32) Sodium starch glycolate Sodium stearyl fumarate Lactose monohydrate Croscarmellose sodium Povidone (K30)
Slovenian: Jedro tablete manitol (E421) magnezijev stearat mikrokristalna celuloza povidon K29/32 natrijev karboksimetilškrob natrijev stearilfumarat laktoza monohidrat premreženi natrijev karmelozat povidon K30 polisorbat 20 silicificirana mikrokristalna celuloza
English: Do not take an antacid during the 6 hours before you take Juluca, or for at least 4 hours after you take it (see also section 3, ‘How to take Juluca')
Slovenian: Ne jemljite antacida manj kot 6 ur preden vzamete zdravilo Juluca in še vsaj 4 ure po tem, ko vzamete to zdravilo (glejte tudi poglavje 3, "Kako jemati zdravilo Juluca"),
English: Do not take an antacid during the 6 hours before you take Juluca, or for at least 4 hours after you take it.
Slovenian: Ne jemljite antacida vsaj 6 ur preden vzamete zdravilo Juluca in še vsaj 4 ure po tem, ko vzamete to zdravilo.
English: Juluca must be taken with a meal.
Slovenian: Zdravilo Juluca je treba vzeti skupaj z obrokom.
English: Limited data are available regarding the use of dolutegravir during pregnancy.
Slovenian: O uporabi dolutegravirja med nosečnostjo je podatkov malo.
English: 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).
Slovenian: Podatkov za bolnike s hudo okvaro jeter (Child-Pugh C) ni, zato uporaba zdravila Juluca pri teh bolnikih ni priporočljiva
English: AUC ↑ 13% Cmin NA Cmax ↑ 21%
Slovenian: AUC ↑ 13 % Cmin NP Cmax ↑ 21 %
English: Oral contraceptives Ethinyl estradiol (EE)1 and Norelgestromin (NGMN)1 / Dolutegravir
Slovenian: Peroralni kontraceptivi etinilestradiol (EE)1 in norelgestromin (NGMN)1/ dolutegravir etinilestradiol (EE)1 in noretindron1/rilpivirin dolutegravir ↔ EE ↔ AUC ↑ 3 % Cmax ↓ 1 %
English: • stiffness in the joints
Slovenian: • bolečine v sklepih,
English: AUC ↓ 76% Cmin NA Cmax ↓ 85%
Slovenian: AUC ↓ 76 % Cmin NP Cmax ↓ 85 %
English: Sofosbuvir ↔ AUC ↔ Cmax ↑ 21% Sofosbuvir metabolite GS
Slovenian: sofosbuvir ↔ AUC ↔ Cmax ↑ 21 % Presnovek sofosbuvirja GS-331007 ↔ AUC ↔
English: common decreased white blood cell count decreased haemoglobin decreased platelet count
Slovenian: pogosti zmanjšanje števila belih krvnih celic znižanje hemoglobina zmanjšanje števila trombocitov
English: Digoxin/ Dolutegravir Digoxin/ Rilpivirine1
Slovenian: digoksin/dolutegravir digoksin/rilpivirin1
English: If a patient vomits within 4 hours of taking Juluca, another Juluca tablet should be taken with a meal.
Slovenian: Če bolnik bruha v obdobju do 4 ure po zaužitju zdravila Juluca, mora vzeti še eno tableto zdravila
English: Patients should be informed that fatigue, dizziness and somnolence have been reported during treatment with the components of Juluca.
Slovenian: Bolnikom je treba povedati, da so med zdravljenjem z učinkovinama, ki ju vsebuje zdravilo Juluca,
English: G118R lowers the susceptibility to dolutegravir in site directed mutants (FC 10), but was not detected in patients receiving dolutegravir in the Phase III program.
Slovenian: G118R zmanjša dovzetnost za dolutegravir pri točkovnih mutantih (FC 10),
English: gp).
Slovenian: AUC).
English: Methadone / Rilpivirine1
Slovenian: metadon/rilpivirin1
English: Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.
Slovenian: Rilpivirin in vivo v mikrojedrnem testu pri miših ni izzval kromosomskih okvar.
English: *** The results of the pooled analysis are in line with those of the individual studies, for which differences in proportions meeting the primary endpoint of <50 copies/mL plasma HIV-1 RNA at Week 48 (based on the Snapshot algorithm) for DTG+RPV versus CAR were -0.6 (95% CI: -4.3; 3.0) for SWORD-1 and 0.2 (95% CI: -3.9; 4.2) for SWORD-2 with a preset noninferiority margin of -10%.
Slovenian: RNA v plazmi po 48 tednih (na podlagi Snapshot algoritma), med DTG + RPV v primerjavi s CAR -0,6 (95 % IZ: -4,3, 3,0) v SWORD-1 in 0,2 (95 % IZ: -3,9, 4,2) v SWORD-2 ob vnaprej določeni meji neinferiornosti -10 %.
English: The combination of Juluca and supplements should be used with particular caution.
Slovenian: Kombinacijo zdravila Juluca in dodatkov je treba uporabljati posebej previdno.
English: What you need to know before you take Juluca
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Juluca Ne jemljite zdravila Juluca:
English: Dolutegravir did not affect male or female fertility in rats at doses up to 1000 mg/kg/day, the highest dose tested (33 times the 50 mg human clinical exposure based on AUC).
Slovenian: Dolutegravir pri podganah v odmerkih do 1000 mg/kg/dan (ki je bil največji testirani odmerek) ni vplival na plodnost samcev ali samic; ta največji testirani odmerek na podlagi AUC ustreza 33kratniku klinične izpostavljenosti pri človeku med uporabo 50 mg).
English: AUC ↔ Cmin NA
Slovenian: AUC ↔ Cmin NP
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions).
Slovenian: dolutegravir ↓ AUC ↓ 54 % Cmax ↓ 57 % C24 ↓ 56 % (Tvorba kompleksa s polivalentnimi ioni).
English: Monitoring of liver function is recommended in patients with hepatitis B and/or C co-infection.
Slovenian: Pri bolnikih, sočasno okuženih s hepatitisom B in/ali C, je priporočljivo spremljati delovanje jeternih funkcij.
English: If calcium or iron supplements, or multivitamins cannot be taken at the same time as Juluca, these supplements are recommended to be administered 6 hours before or 4 hours after taking Juluca (see section
Slovenian: Če kalcijevih ali železovih dodatkov ali multivitaminskih pripravkov ni mogoče vzeti sočasno z zdravilom Juluca, jih je priporočljivo vzeti 6 ur pred zaužitjem zdravila Juluca ali 4 ure po tem (glejte poglavje 4.5).
English: Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Slovenian: Ena tableta vsebuje dolutegravir v obliki natrijeve soli, ki je ekvivalentna 50 mg dolutegravirja, in rilpivirinijev klorid, ki je ekvivalenten 25 mg rilpivirina.
English: 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.
Slovenian: Rezultati rilpivirina v Amesovem preizkusu reverznih mutacij in vitro ter preizkusu klastogenosti na celicah mišjega limfoma in vitro so bili negativni tako v prisotnosti kot v odsotnosti sistema presnovne aktivacije.
English: No relevant effects were seen with dolutegravir on the QTc interval, with doses exceeding the clinical dose by approximately three fold.
Slovenian: Med uporabo odmerkov, ki so za približno trikrat presegali klinični odmerek, niso odkrili pomembnih učinkov dolutegravirja na interval QTc.
English: After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4-5 hours.
Slovenian: Po peroralni uporabi je največja koncentracija rilpivirina v plazmi praviloma dosežena v
English: Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions).
Slovenian: dolutegravir ↓ AUC ↓ 39 % Cmax ↓ 37 % C24 ↓ 39 % (Tvorba kompleksa s polivalentnimi ioni).
English: The apparent volume of distribution is 17 L to 20 L in HIV-infected patients, based on a population pharmacokinetic analysis.
Slovenian: Navidezni volumen porazdelitve je na podlagi populacijske farmakokinetične analize pri bolnikih, okuženih s HIV, od 17 do 20 l. Vezava dolutegravirja na beljakovine v plazmi ni odvisna od njegove koncentracije.
English: Juluca contains lactose.
Slovenian: Zdravilo Juluca vsebuje laktozo.
English: Co-administration of Juluca with these metabolic inducers is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravila Juluca s temi induktorji presnove je kontraindicirana (glejte poglavje 4.3).
English: AUC ↓ 14% Cmin NA Cmax ↓ 14%
Slovenian: AUC ↓ 14 % Cmin NP Cmax ↓ 14 %
English: Antacids, to treat indigestion and heartburn, can stop Juluca being absorbed into your body and make it less effective.
Slovenian: Antacidi, ki se uporabljajo za zdravljenje težav z želodcem in zgage, lahko preprečijo absorpcijo zdravila Juluca v telo in zmanjšajo njegovo učinkovitost.
English: Hepatic impairment
Slovenian: Srčno-žilni učinki
English: Primary mutations for raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q, T66I) do not affect the in vitro susceptibility of dolutegravir as single mutations.
Slovenian: vendar ga niso opazili pri bolnikih, ki so prejemali dolutegravir v programu faze III. Primarne mutacije za raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q, T66I)
English: Analgesics Methadone/ Dolutegravir1
Slovenian: Analgetiki metadon/dolutegravir1
English: This may result in
Slovenian: Njim bi lahko celo škodovalo,
English: Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions).
Slovenian: dolutegravir ↓ AUC ↓ 33 % Cmax ↓ 35 % C24 ↓ 32 % (Tvorba kompleksa s polivalentnimi ioni).