FrancophonIA/ELRC3.0 huggingface dataset:
English: No drug interaction studies have been conducted using Dovato.
Slovenian: Študije medsebojnega delovanja z zdravili za zdravilo Dovato niso bile izvedene.
English: Each pack consists of one bottle containing 30 filmcoated tablets.
Slovenian: Eno pakiranje sestavlja en vsebnik, ki vsebuje 30 filmsko obloženih tablet.
English: Joint pain, stiffness and bone problems
Slovenian: Bolečine v sklepih, otrplost in težave s kostmi
English: The mean ratio of CSF/serum lamivudine concentrations 2-4 hours after oral administration was approximately 12%.
Slovenian: Od 2 do 4 ure po peroralnem dajanju je bilo srednje razmerje koncentracij lamivudina CST/serum približno 12 %.
English: In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients.
Slovenian: In vivo so pri bolnikih opazili 1014% zmanjšanje očistka kreatinina (sekretorna frakcija je odvisna od prenosa OCT2 in MATE-1).
English: In vitro, dolutegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
Slovenian: Dolutegravir ni induciral CYP1A2, CYP2B6 ali CYP3A4 in vitro.
English: The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 28.5 and 1.1 times the 50 mg human clinical exposure following single dose in the fasted state based on AUC, respectively.
Slovenian: Primarni učinek dolutegravirja na podganah in opicah je bil gastrointestinalna intoleranca ali draženje, in sicer z odmerki, pri katerih je bila sistemska izpostavljenost približno 28,5- oziroma 1,1-krat tolikšna kot klinična izpostavljenost pri človeku med uporabo 50 mg po enem odmerku na tešče na podlagi AUC.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACKS ONLY - WITH BLUE BOX)
Slovenian: ŠKATLA (SAMO SKUPNA PAKIRANJA - Z »BLUE BOX«)
English: Data obtained in patients with moderate to severe hepatic impairment show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Slovenian: Podatki, pridobljeni pri bolnikih z zmerno do hudo jetrno okvaro, kažejo, da okvarjeno delovanje jeter na farmakokinetične lastnosti lamivudina znatneje ne vpliva.
English: No dose adjustment is necessary when Dovato is combined with tenofovir, didanosine, stavudine or zidovudine.
Slovenian: Kadar se zdravilo Dovato uporablja v kombinaciji s tenofovirjem, didanozinom, stavudinom ali zidovudinom prilagajanje odmerka ni potrebno.
English: Interaction not studied containing products, since both lamivudine (in Dovato) and emtricitabine are cytidine analogues (i.e. risk for intracellular interactions, (see section 4.4).
Slovenian: Zdravila Dovato ni priporočljivo uporabljati v kombinaciji z zdravili, ki vsebujejo emtricitabin, ker sta tako lamivudin (v zdravilu Dovato) kot tudi emtricitabin analoga citidina (tj. tveganje za znotrajcelične interakcije, (glejte poglavje 4.4)).
English: • medicines called antacids, to treat indigestion and heartburn.
Slovenian: • zdravila, imenovana antacidi, za zdravljenje prebavnih motenj in zgage.
English: Etravirine without boosted protease inhibitors decreased plasma dolutegravir concentration.
Slovenian: Etravirin brez okrepljenih zaviralcev proteaz je znižal plazemsko
English: Magnesium/ aluminium-containing antacids should be taken well separated in time from the administration of Dovato (minimum 2 hours after or 6 hours before).
Slovenian: Antacide, ki vsebujejo magnezij ali aluminij, je treba vzeti s precejšnjim časovnim zamikom (minimalno 2 uri po ali 6 ur pred uporabo zdravila Dovato).
English: The mean IC50 against lab-strains of HIV-2 (LAV2 and EHO) ranged from 0.16 to 0.51 µM for lamivudine.
Slovenian: Povprečne vrednosti IC50 proti laboratorijskim sevom HIV-2 (LAV2 in EHO) so segale od 0,16 do 0,51 M za lamivudin.
English: • a high temperature (fever)
Slovenian: • povišana telesna temperatura (vročina)
English: Dovato should not be co-administered with polyvalent cation-containing antacids.
Slovenian: Zdravila Dovato se ne sme dajati sočasno z antacidi, ki vsebujejo polivalentne katione.
English: Antacids, to treat indigestion and heartburn, can stop Dovato being absorbed into your body and make it less effective.
Slovenian: Antacidi, ki se uporabljajo za zdravljenje prebavnih motenj in zgage, lahko preprečijo absorpcijo zdravila Dovato v telo in povzročijo, da je zdravilo manj učinkovito.
English: Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of Dovato.
Slovenian: Ženske v rodni dobi morajo pred začetkom jemanja zdravila Dovato opraviti test nosečnosti.
English: • St. John's wort (Hypericum perforatum), a herbal remedy to treat depression.
Slovenian: • šentjanževka (Hypericum perforatum), zeliščni pripravek za zdravljenje depresije
English: The most severe adverse reaction reported with dolutegravir was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4).
Slovenian: Najresnejši neželeni učinek, poročan pri dolutegravirju, je bila preobčutljivostna reakcija z izpuščajem in hudo prizadetostjo jeter (glejte poglavje 4.4).
English: Dolutegravir is an OCT2 and MATE1 inhibitor; however, lamivudine concentrations were similar with or without co-administration of dolutegravir based on a cross study analysis, indicating that dolutegravir has no relevant effect on lamivudine exposure in vivo.
Slovenian: Dolutegravir je zaviralec OCT2 in MATE1, vendar pa je navzkrižna analiza pokazala, da so bile ravni lamivudina ob sočasnem jemanju dolutegravirja ali brez njega podobne, kar kaže na to, da dolutegravir ne vpliva pomembno na izpostavljenost lamivudinu in vivo.
English: Dovato can make you dizzy, and have other side effects that make you less alert.
Slovenian: Zdravilo Dovato vam lahko povzroči omotico in ima druge neželene učinke, ki lahko zmanjšajo zbranost.
English: How to take Dovato
Slovenian: Kako jemati zdravilo Dovato
English: Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some subjects with hepatitis B and/or C co-infection at the start of dolutegravir therapy, particularly in those whose anti-hepatitis B therapy was withdrawn (see section 4.4).
Slovenian: Zvišane biokemijske vrednosti jetrnih testov, značilne za sindrom imunske rekonstitucije, so ob začetku zdravljenja z dolutegravirjem opazili pri nekaterih bolnikih, sočasno okuženih tudi z virusom hepatitisa B in/ali C, posebej še pri tistih, pri katerih je bila terapija proti hepatitisu B ukinjena (glejte poglavje 4.4).
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Slovenian: Pri bolnikih s HIV, ki imajo ob uvedbi kombinirane protiretrovirusne terapije (CART) hudo imunsko pomanjkljivost, se lahko pojavi vnetna reakcija na asimptomatske ali oportunistične okužbe z rezidualnimi patogeni.
English: The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to 17 years) showed that dolutegravir 50 mg once daily dosage resulted in dolutegravir exposure comparable to that observed in adults who received dolutegravir 50 mg once daily.
Slovenian: Farmakokinetika dolutegravirja pri 10 mladostnikih (starih od 12 do 17 let), ki so bili okuženi z virusom HIV-1 in so predhodno že prejemali protiretrovirusno zdravljenje, je pokazala, da odmerek 50 mg dolutegravirja enkrat dnevno doseže izpostavljenost, ki je primerljiva z izpostavljenostjo odraslih med jemanjem odmerka 50 mg dolutegravirja enkrat dnevno.
English: If you do not take Dovato with food, do not take a supplement or multivitamin containing calcium, iron or magnesium during the 6 hours before you take Dovato, or for at least 2 hours after you take it.
Slovenian: Če ne jemljete zdravila Dovato s hrano, ne vzemite dodatka ali multivitaminskega pripravka, ki vsebuje kalcij, železo ali magnezij v 6 urah pred jemanjem zdravila Dovato ali vsaj 2 uri po tem, ko ste ga vzeli.
English: Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it (see also section 3, ‘How to take Dovato')
Slovenian: V 6 urah pred jemanjem zdravila Dovato ali vsaj 2 uri po tem, ko ste ga vzeli, ne jemljite antacida (glejte tudi poglavje 3 »Kako jemati zdravilo Dovato«)
English: If you notice any of these symptoms: → Tell your doctor.
Slovenian: • oteženo gibanje Če opazite katerega od teh simptomov: → se posvetujte z zdravnikom.
English: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Slovenian: Dokazano je, da nukleozidni in nukleotidni analogi in vitro in in vivo v različni meri okvarijo mitohondrije.
English: There is no evidence that a dose adjustment of dolutegravir or lamivudine would be required based on the effects of race on PK parameters.
Slovenian: Ni dokazov, da bi bilo potrebno odmerke dolutegravirja ali lamivudina prilagajati zaradi vpliva rase na farmakokinetične parametre.
English: Each bottle contains 30 film-coated tablets.
Slovenian: Ena plastenka vsebuje 30 filmsko obloženih tablet.
English: There is no evidence that a dose adjustment of dolutegravir or lamivudine would be required based on the effects of gender on PK parameters.
Slovenian: Ni dokazov, da bi bilo potrebno odmerke dolutegravirja ali lamivudina prilagajati zaradi vpliva spola na farmakokinetične parametre.
English: If you do not take Dovato with food, do not take a supplement or multivitamin containing calcium, iron or magnesium during the 6 hours before you take Dovato, or for at least 2 hours after you take it (see also section 3, ‘How to take Dovato')
Slovenian: Če ne jemljete zdravila Dovato s hrano, ne vzemite dodatka ali multivitaminskega pripravka, ki vsebuje kalcij, železo ali magnezij v 6 urah pred jemanjem zdravila Dovato ali vsaj 2 uri po tem, ko ste ga vzeli (glejte tudi poglavje 3 »Kako jemati zdravilo Dovato«).
English: If Dovato is administered under fasting conditions, supplements or multivitamins containing calcium, iron or magnesium are recommended to be taken 2 hours after or 6 hours before Dovato (see section 4.5).
Slovenian: Če se zdravilo Dovato jemlje na tešče, je priporočljivo, da se dodatke ali multivitaminske pripravke, ki vsebujejo kalcij, železo ali magnezij, vzame 2 uri po ali 6 pred uporabo zdravila Dovato (glejte poglavje 4.5).
English: Drug Interactions Medicinal products by therapeutic areas
Slovenian: Zdravila po terapevtskih področjih
English: Virologic Outcomes of Randomised Treatment at Week 48 (Snapshot algorithm) GEMINI-1 and GEMINI-2 Pooled Data*
Slovenian: Preglednica 3 Virološki izidi randomiziranega zdravljenja po 48 tednih (“Snapshot” algoritem) Združeni podatki študij GEMINI-1 in GEMINI-2* DTG + 3TC N = 716
English: Concomitant use of Dovato with cladribine is not recommended (see section 4.4).
Slovenian: Sočasna uporaba zdravila Dovato in kladribina ni priporočljiva (glejte poglavje 4.4).
English: At week 48, dolutegravir plus lamivudine was non-inferior to dolutegravir plus tenofovir disoproxil/emtricitabine FDC in GEMINI-1 and GEMINI-2 studies.
Slovenian: Po 48 tednih je bila kombinacija dolutegravirja in lamivudina v študijah GEMINI-1 in GEMINI-2 neinferiorna kombinaciji dolutegravirja in dizoproksiltenofovirata/emtricitabina FDC.
English: Multipacks containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available.
Slovenian: Na voljo je tudi večkratno pakiranje, ki vsebuje 90 filmsko obloženih tablet (3 pakiranja po 30 filmsko obloženih tablet).
English: Musculoskeletal and connective tissue disorders: Common:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti:
English: Binding of dolutegravir to plasma proteins is independent of dolutegravir concentration.
Slovenian: Vezava dolutegravirja na plazemske proteine je neodvisna od koncentracije dolutegravirja.
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”).
Slovenian: Interakcije med dolutegravirjem, lamivudinom in sočasno uporabljenimi zdravili so navedene v Preglednici 1 (zvečanje je označeno kot “↑”, zmanjšanje kot “↓”, brez spremembe kot “↔”, površina pod koncentracijsko krivuljo v odvisnosti od časa kot “AUC”, maksimalna zabeležena koncentracija pa kot “Cmax”).
English: Based on the lamivudine data, Dovato is not recommended for patients with creatinine clearance of < 50 mL/min.
Slovenian: Na osnovi podatkov za lamivudin pri bolnikih z očistkom kreatinina < 50 ml/min uporaba zdravila Dovato ni priporočljiva.
English: • a decreased number of cells involved in blood clotting (thrombocytopenia)
Slovenian: • zmanjšano število krvnih celic, ki so pomembne pri strjevanju krvi (trombocitopenija),
English: Cytotoxics Cladribine/Lamivudine
Slovenian: Citotoksična zdravila kladribin/lamivudin
English: Dovato contains dolutegravir.
Slovenian: Zdravilo Dovato vsebuje dolutegravir.
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.55 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
Slovenian: Pri kuncih so toksične učinke pri samicah materah (zmanjšano uživanje hrane, nezadostno izločanje/brez izločanja blata/urina, zavrto pridobivanje telesne mase) opazili pri 1000 mg/kg (0,55-kratnik klinične izpostavljenosti pri človeku, kadar se daje odmerek 50 mg, na podlagi AUC po enem odmerku na tešče).
English: • if they are overweight.
Slovenian: • ki imajo prekomerno telesno maso.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INDIVIDUAL PACKS ONLY)
Slovenian: ŠKATLA (SAMO POSAMIČNA PAKIRANJA)
English: In vitro, dolutegravir inhibited the renal uptake organic anion transporters (OAT)1 and OAT3.
Slovenian: In vitro je dolutegravir zaviral organske anionske prenašalce privzema v ledvicah (OAT) 1 in OAT3.
English: Single dose lamivudine oral solution 300 mg. Lamivudine:
Slovenian: Enkraten odmerek lamivudina 300 mg peroralne raztopine lamivudin:
English: Antiretroviral medicinal products Non-nucleoside reverse transcriptase inhibitors Etravirine without boosted protease inhibitors /
Slovenian: Protiretrovirusna zdravila Nenukleozidni zaviralci reverzne transkriptaze etravirin brez okrepljenih zaviralcev proteaz/dolutegravir dolutegravir  AUC  71 %
English: Dolutegravir is highly bound (> 99%) to human plasma proteins based on in vitro data.
Slovenian: Podatki in vitro kažejo, da je dolutegravir v veliki meri (> 99 %) vezan na humane plazemske proteine.
English: In previously untreated patients receiving dolutegravir + 2 NRTIs in Phase IIb and Phase III, no development of resistance to the integrase inhibitor class, or to the NRTI class was seen (n=1118 follow-up of 48-96 weeks).
Slovenian: niso opazili razvoja odpornosti na zdravila iz skupine zaviralcev integraz ali NRTI (n = 1118, spremljanje 48-96 tednov).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
Slovenian: Imetnik dovoljenja za promet z zdravilom ViiV Healthcare BV
English: No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh grade A or B).
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter (Child-Pugh stopnja A ali B) prilagajanje odmerka ni potrebno.
English: Multipacks containing 90 (3 packs of 30) film-coated tablets.
Slovenian: Skupno pakiranje vsebuje 90 (3 pakiranja po 30) filmsko obloženih tablet.
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Slovenian: Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi (glejte poglavje 4.4).
English: If you are breast-feeding, or thinking about breast-feeding: → Talk to your doctor immediately.
Slovenian: Če dojite ali nameravate dojiti: → Nemudoma se posvetujte z zdravnikom.
English: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Slovenian: Če pa se kronični sočasni uporabi ni mogoče izogniti, pogosteje kontrolirajte virusno breme HIV-1.
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zdravila za zdravljenje infekcij s HIV, kombinacije, oznaka ATC: J05AR25
English: • inflammation of the pancreas (pancreatitis)
Slovenian: • vnetje trebušne slinavke (pankreatitis)
English: Dolutegravir ↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected).
Slovenian: Zeliščni pripravki šentjanževka/dolutegravir dolutegravir (ni raziskano; pričakovano zmanjšanje zaradi indukcije encimov UGT1A1 in CYP3A, pričakovati je mogoče podobno zmanjšanje izpostavljenosti, kot je ugotovljeno s karbamazepinom)
English: hypersensitivity (see section 4.4), immune reconstitution syndrome (see section 4.4)
Slovenian: preobčutljivost (glejte poglavje 4.4), sindrom imunske rekonstitucije (glejte poglavje 4.4) Presnovne in prehranske motnje: zelo redki:
English: HIV-1 RNA <50 copies/mL Treatment Difference† (95% confidence intervals) Virologic non response
Slovenian: HIV-1 RNK < 50 kopij/ml Razlika med zdravljenjema
English: The absorption of dolutegravir is reduced by certain metal cation-containing anti-acid substances and supplements (see Table 1).
Slovenian: Določeni antacidi in dodatki, ki vsebujejo kovinske katione, zmanjšujejo absorpcijo dolutegravirja (glejte Preglednico 1).
English: Mitochondrial dysfunction
Slovenian: Moteno delovanje mitohondrijev
English: In vitro, lamivudine did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrated no or weak inhibition of OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 or MATE2-K. Lamivudine is therefore not expected to affect the plasma concentrations of medicinal products that are substrates of these enzymes or transporters.
Slovenian: In vitro lamivudin ni ne zaviral ne induciral encimov CYP (npr. CYP3A4, CYP2C9 ali CYP2D6) in ni zaviral ali je le šibko zaviral OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 ali MATE2-K.
English: Sofosbuvir/ Velpatasvir/Dolutegravir
Slovenian: sofosbuvir/ velpatasvir/dolutegravir dolutegravir  sofosbuvir  velpatasvir
English: People may be more likely to get this condition:
Slovenian: Verjetnost za pojav te bolezni je večja pri posameznikih:
English: Effect of dolutegravir: NGMN ↔ AUC ↓ 2% Cmax ↓ 11%
Slovenian: Učinek dolutegravirja: NGMN  AUC  2 % Cmax  11 %
English: Blood and lymphatic systems disorders: Uncommon:
Slovenian: Bolezni krvi in limfatičnega sistema: občasni:
English: Renal impairment Pharmacokinetic data have been obtained for dolutegravir and lamivudine separately.
Slovenian: Okvara jeter Farmakokinetični podatki so bili pridobljeni za dolutegravir in lamivudin posamezno.
English: The apparent oral clearance (CL/F) is approximately 1 L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Slovenian: Na podlagi populacijske farmakokinetične analize je navidezni peroralni očistek (CL/F) pri bolnikih, okuženih z virusom HIV, približno 1 l/uro.
English: Darunavir ↔ Ritonavir ↔ Etravirine ↔
Slovenian: darunavir  ritonavir  etravirin 
English: People taking combination therapy for HIV may get other side effects.
Slovenian: Bolnikom, ki jemljejo kombinirano zdravljenje za zdravljenje okužbe s HIV, se lahko pojavijo drugi neželeni učinki.
English: Population PK analyses using pooled pharmacokinetic data from clinical studies where dolutegravir or lamivudine was administered to adults in combination with other ARVs revealed no clinically relevant effect of gender on the exposure of dolutegravir or lamivudine.
Slovenian: Populacijske farmakokinetične analize kumulativnih farmakokinetičnih podatkov iz kliničnih študij, kjer sta bila dolutegravir ali lamivudin uporabljena v kombinaciji z drugimi ARV pri odraslih niso pokazale klinično pomembnega vpliva spola na izpostavljenost dolutegravirju ali lamivudinu.
English: In vitro, dolutegravir inhibited the renal transporters OCT2 and MATE1.
Slovenian: In vitro je dolutegravir zaviral prenašalca OCT2 in MATE1 v ledvicah.
English: Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (37.2 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
Slovenian: Peroralna uporaba dolutegravirja pri brejih podganah v odmerkih do 1000 mg/kg na dan od 6. do 17. dne gestacije ni povzročila toksičnih učinkov pri samicah materah, razvojnih toksičnih učinkov ali teratogenih učinkov (37,2-kratnik klinične izpostavljenosti pri človeku, kadar se daje odmerek 50 mg, na podlagi AUC po enem odmerku na tešče).
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir (see section 4.5).
Slovenian: Priporočeni odmerek dolutegravirja med sočasno uporabo z rifampicinom, karbamazepinom, okskarbazepinom, fenitoinom, fenobarbitalom, šentjanževko, etravirinom (brez okrepljenih zaviralcev proteaz), efavirenzom, nevirapinom ali tipranavirjem/ritonavirjem je 50 mg dvakrat na dan (glejte poglavje
English: These include:
Slovenian: Med temi so:
English: No dosage adjustment necessary.
Slovenian: Prilagajanje odmerka ni potrebno.
English: Dolutegravir ↓ (Not studied, a similar reduction in exposure as observed with efavirenz is expected, due to induction)
Slovenian: nevirapin/dolutegravir dolutegravir  (Ni raziskano; zaradi indukcije se pričakuje podobno zmanjšanje izpostavljenosti kot pri efavirenzu)
English: † Based on CMH-stratified analysis adjusting for the following baseline stratification factors: Plasma HIV-1 RNA (≤100,000 c/mL vs. >100,000 c/mL) and CD4+ cell count (≤200 cells/mm3 vs. >200 cells/mm3).
Slovenian: † Na podlagi CMH-stratificirane analize s prilagoditvijo za naslednja izhodiščna stratifikacijska dejavnika: HIV-1 RNK v plazmi (≤ 100.000 k/ml v prim.
English: • wind (flatulence)
Slovenian: • vetrovi (napihnjenost)
English: General disorders and administration site conditions: Common:
Slovenian: Splošne težave in spremembe na mestu aplikacije: pogosti:
English: None of the six subjects in the dolutegravir plus lamivudine group or the four subjects in the dolutegravir plus tenofovir disoproxil/emtricitabine FDC group that met virological withdrawal criteria through Week 48 across the GEMINI-1 (204861) and GEMINI-2 (205543) studies had treatment emergent integrase inhibitor or NRTI class resistance.
Slovenian: Med zdravljenjem nastala odpornost na skupino zaviralcev integraze oz. NRTI se ni pojavila pri nobenem izmed 6 preiskovancev v skupini z dolutegravirjem in lamivudinom in pri nobenem od 4 preiskovancev v skupini z dolutegravirjem in dizoproksiltenofoviratom/emtricitabinom FDC, ki so v študijah GEMINI-1 (204861) in GEMINI-2 (205543) izpolnjevali virološka merila za umik v obdobju do 48. tedna.
English: Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Slovenian: Študije pri bolnikih z ledvično okvaro so pokazale, da okvara delovanja ledvic vpliva na izločanje lamivudina.
English: Dovato includes lamivudine, which is active against hepatitis B. Dolutegravir lacks such activity.
Slovenian: Zdravilo Dovato vsebuje lamivudin, ki deluje proti hepatitisu B (HBV).