FrancophonIA/ELRC3.0 huggingface dataset:
English: The combination of abacavir/lamivudine has demonstrated decreased susceptibility to viruses with the substitutions K65R with or without the M184V/I substitution, and to viruses with L74V plus the M184V/I substitution.
Slovenian: Kombinacija abakavirja/lamivudina je pokazala zmanjšano občutljivost na viruse s substitucijo K65R z ali brez substitucije M184V/I ter za viruse s substitucijo L74V in M184V/I.
English: Patients should be informed that dizziness has been reported during treatment with dolutegravir.
Slovenian: Bolnike je potrebno obvestiti, da so poročali o pojavu omotice med zdravljenjem z dolutegravirjem.
English: Using strain NL432 mutations E92Q (fold change 3) and G193E (fold change 3) were selected.
Slovenian: Pri uporabi seva NL432 so bile izbrane mutacije E92Q (sprememba občutljivosti 3) in G193E (sprememba občutljivosti 3).
English: Baseline demographics and outcomes are summarised in Table 4.
Slovenian: Izhodiščni demografski podatki in izidi so povzeti v preglednici 4.
English: † Includes subjects who discontinued prior to Week 48 for lack or loss of efficacy and subjects who are ≥50 copies in the 48 week window.
Slovenian: † Vključuje preiskovance, ki so prenehali sodelovati pred 48. tednom zaradi pomanjkanja ali izgube učinkovitosti, in bolnike z 50 kopijami v 48. tednu.
English: Diagnosis of Abacavir Hypersensitivity Reaction Major symptoms associated with ABC HSR are fever (~80%), rash (~70%), gastrointestinal symptoms (>50%) such as nausea, abdominal pain, vomiting, and diarrhoea, generalise malaise, fatigue, and headache (~50%) and other symptoms (~30%) such as respiratory, mucosal, and musculoskeletal symptoms.
Slovenian: Diagnoza preobčutljivostne reakcije na abakavir Glavni simptomi, povezani s preobčutljivostjo za ABC, so povišana telesna temperatura (~80%), izpuščaj (~70%), gastrointestinalni simptomi (>50), kot so navzea, bolečine v trebuhu, bruhanje in driska, splošno slabo počutje, utrujenost in glavobol (~50%) ter drugi simptomi (~30%), kot so bolezni dihal, sluznic in mišično-skeletni simptomi.
English: IMPORTANT - PATIENT ALERT CARD Triumeq (dolutegravir / abacavir / lamivudine) tablets Carry this card with you at all times
Slovenian: POMEMBNO - OPOZORILNA KARTICA ZA BOLNIKA Tablete Triumeq (dolutegravir/abakavir/lamivudin) To kartico imejte vedno pri sebi.
English: immune reconstitution syndrome (see section 4.4) Metabolism and nutrition disorders: Common:
Slovenian: sindrom imunske rekonstitucije (glejte poglavje 4.4) Presnovne in prehranske motnje:
English: 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.
Slovenian: Ko se mutacije, navedene kot sekundarne mutacije povezane z zaviralci integraze (za raltegravir/elvitegravir), v poskusih s točkovnimi mutanti dodajo primarnim mutacijam (razen pri Q148), občutljivost na dolutegravir ostaja enaka ali blizu ravni divjega fenotipa.
English: Purple, biconvex, film-coated oval tablets, approximately 22 x 11 mm, debossed with “572 Trı” on one side.
Slovenian: Vijolične, bikonveksne, ovalne filmsko obložene tablete, velikosti približno 22 x 11 mm, z vtisnjeno oznako ‘572 Trı' na eni strani.
English: There is no specific treatment for an overdose of Triumeq.
Slovenian: Specifičnega zdravljenja pri prevelikem odmerjanju zdravila Triumeq ni.
English: The pharmacokinetics of abacavir in patients with end-stage renal disease is similar to patients with normal renal function.
Slovenian: Pri bolnikih s terminalnim stadijem ledvične bolezni je farmakokinetika abakavirja podobna kot pri bolnikih z normalnim delovanjem ledvic.
English: Uncommon side effects that may show up in blood tests are:
Slovenian: Občasni neželeni učinki, ki se lahko pokažejo pri pregledu krvi, so:
English: Abacavir:
Slovenian: abakavir:
English: The most frequently reported adverse reactions considered possibly or probably related to dolutegravir and abacavir/lamivudine were nausea (12%), insomnia (7%), dizziness (6%) and headache (6%).
Slovenian: Med neželenimi učinki, ki so lahko ali so verjetno povezani z dolutegravirjem in abakavirjem/lamivudinom, poročila najpogosteje navajajo navzeo (12%), nespečnost (7%), omotico (6%) in glavobol (6%).
English: During in vitro abacavir selection the M184V mutation occurred first and resulted in about a 2-fold increase in IC50, below the abacavir clinical cut-off of 4.5-fold change.
Slovenian: Med selekcijo za abakavir in vitro se je selekcija za mutacijo M184V pojavila prva in je povzročila 2-kratno povečanje IC50 pod klinično presečno 4,5-kratno spremembo občutljivosti na abakavir.
English: Time to onset was typically 10-14 days for both abacavir and dolutegravir-associated reactions, although reactions to abacavir may occur at any time during therapy.
Slovenian: Čas do pojava je bil običajno 10-14 dni tako za reakcije, povezane z abakavirjem, kot tudi za tiste, povezane z dolutegravirjem, vendar pa se lahko reakcije na abakavir pojavijo kadar koli v času zdravljenja.
English: • an increase in triglycerides (type of fat) in the blood
Slovenian: • povišana vrednost trigliceridov (vrsta maščobe) v krvi
English: Hypersensitivity reaction observed for each of these medicinal products (described below) share some common features such as fever and/or rash with other symptoms indicating multi-organ involvement.
Slovenian: Preobčutljivostne reakcije, ki so jih opazili pri vsakem od teh zdravil (opisane v nadaljevanju), imajo nekatere skupne značilnosti, kot so povišana telesna temperatura in/ali izpuščaj z drugimi simptomi, ki kažejo na prizadetost več organov.
English: The terminal intracellular half-life of lamivudine-TP was prolonged to 16-19 hours, compared to the plasma lamivudine half-life of 5-7 hours, supporting once daily dosing of ABC and 3TC.
Slovenian: Končni znotrajcelični razpolovni čas lamivudina-TP je bil podaljšan na 16-19 ur, v primerjavi z razpolovnim časom lamivudina v plazmi, ki je bil 5-7 ur, kar podpira odmerjanje ABC in 3TC enkrat dnevno.
English: Virologic suppression (HIV-1 RNA <50 copies/mL) in the ABC/DTG/3TC FDC group (85%) was statistically non-inferior to the current ART groups (88%) at 24 weeks.
Slovenian: Virološka supresija (HIV-1 RNA < 50 kopij/ml) v skupini z ABC/DTG/3TC FDC (85 %) je bila po 24 tednih statistično neinferiorna tisti v skupinah s trenutnim ART (88 %).
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Slovenian: Pri bolnikih z že obstoječo okvaro jeter, vključno z aktivnim kroničnim hepatitisom, se med kombiniranim protiretrovirusnim zdravljenjem pogosteje pojavljajo nepravilnosti v delovanju jeter in jih je treba spremljati v skladu s standardno prakso.
English: The effect of the Q148-based mutations (H/R/K) was also consistent with in vitro passage experiments with site directed mutants.
Slovenian: Vpliv mutacij Q148 (H/R/K) je bil skladen tudi s poskusi prehajanja s točkovnimi mutanti in vitro.
English: HIV-1 isolates (CRF01_AE, n=12; CRF02_AG, n=12; and Subtype C or CRF_AC, n=13) from 37 untreated patients in Africa and Asia were susceptible to abacavir (IC50 fold changes < 2.5), and lamivudine (IC50 fold changes < 3.0), except for two CRF02_AG isolates with fold changes of 2.9 and 3.4 for abacavir.
Slovenian: Izolati HIV-1 (CRF01_AE n = 12, CRF02_AG n = 12 in podtip C ali CRF_AC n = 13) 37 nezdravljenih bolnikov v Afriki in Aziji so bili občutljivi na abakavir (< 2,5-kratne spremembe IC50) in lamivudin (< 3,0-kratne spremembe IC50 ), razen 2 izolatov CRF02_AG z 2,9- in 3,4-kratno spremembo za abakavir.
English: Rash (usually maculopapular or urticarial)
Slovenian: Koža izpuščaj (običajno makulopapularni ali urtikarijski)
English: This reaction can be life-threatening if treatment with Triumeq is continued.
Slovenian: Ta reakcija je lahko življenjsko nevarna, če se zdravljenje s tem zdravilom nadaljuje.
English: Hypersensitivity reactions have been observed more commonly with abacavir, some of which have been life-threatening, and in rare cases fatal, when not managed appropriately.
Slovenian: Pogosteje so opazili preobčutljivostne reakcije na abakavir, od katerih so bile nekatere življenjsko ogrožujoče in v redkih primerih usodne, če niso bile ustrezno obravnavane.
English: This variant arises both in vitro and in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Slovenian: Ta različica se pojavi tako in vitro kot tudi pri z virusom HIV-1 okuženih bolnikih, ki so bili zdravljeni s protivirusnim zdravilom, ki je vsebovalo lamivudin.
English: Concerning lamivudine, a large amount of data (more than 3000 outcomes from first trimester) indicates no malformative toxicity.
Slovenian: Glede lamivudina pa obstaja velika količina podatkov (več kot 3000 izidov po izpostavljenosti v prvem trimesečju), ki niso pokazali malformacijske toksičnosti.
English: Dolutegravir is the predominant circulating compound in plasma; renal elimination of unchanged active substance is low (< 1% of the dose).
Slovenian: Dolutegravir je prevladujoča snov, ki kroži v plazmi, izločanje nespremenjene zdravilne učinkovine preko ledvic je majhno (< 1% odmerka).
English: Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of Triumeq.
Slovenian: Ženske v rodni dobi morajo pred začetkom jemanja zdravila Triumeq opraviti test nosečnosti.
English: G118R lowers the susceptibility to dolutegravir in site directed mutants (fold change 10), but was not detected in patients receiving dolutegravir in the Phase III program.
Slovenian: G118R zmanjša občutljivost na dolutegravir pri točkovnih mutantih (sprememba občutljivosti 10), vendar ga niso opazili pri bolnikih, ki so prejemali dolutegravir v programu faze III.
English: This medicine does not require any special temperature storage conditions.
Slovenian: Za shranjevanje tega zdravila ni posebnih zahtev glede temperature.
English: These results indicate that Triumeq can be taken with or without food.
Slovenian: Ti rezultati kažejo, da se zdravilo Triumeq lahko jemlje s hrano ali brez nje.
English: HIV-1 resistance to lamivudine involves the development of a M184I or M184V amino acid change close to the active site of the viral RT.
Slovenian: Odpornost virusa HIV-1 na lamivudin vključuje nastanek M184I ali M184V aminokislinske spremembe blizu aktivnega mesta virusne RT.
English: Some medicines can affect how Triumeq works, or make it more likely that you will have side effects.
Slovenian: Nekatera zdravila lahko vplivajo na delovanje zdravila Triumeq ali povečajo verjetnost, da se pri vas pojavijo neželeni učinki.
English: Dolutegravir is eliminated mainly through metabolism by uridine diphosphate glucuronosyl transferase (UGT) 1A1.
Slovenian: Dolutegravir se izloča predvsem s presnovo preko uridindifosfat-glukuronoziltransferazo (UGT) 1A1.
English: A study of the pharmacokinetics of dolutegravir was performed in subjects with severe renal impairment (CLcr <30 mL/min).
Slovenian: Študijo farmakokinetike dolutegravirja so izvedli pri preiskovancih s hudo okvaro ledvic (Clcr <30 ml/min).
English: The statistically higher responses on DTG+ABC/3TC were driven by a higher rate of withdrawals due to AEs in the EFV/TDF/FTC arm, irrespective of viral load strata.
Slovenian: Statistično višji odzivi v skupini z DTG+ABC/3TC so bili posledica višjega odstotka prekinitev zaradi neželenih učinkov v skupini z EFV/TDF/FTC, ne glede na stopnjo virusnega bremena.
English: - In order to avoid restarting abacavir and dolutegravir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Triumeq tablets.
Slovenian: - Da bi se izognili ponovni uporabi abakavirja in dolutegravirja, je treba bolnikom, pri katerih se je pojavil sum na preobčutljivostno reakcijo, naročiti, da preostale tablete zdravila Triumeq zavržejo.
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues, these have predominantly concerned treatment with regimens containing zidovudine.
Slovenian: Obstajajo poročila o mitohondrijski disfunkciji pri HIV-negativnih dojenčkih, ki so bili in utero in/ali po rojstvu izpostavljeni nukleozidnim analogom; ta so pretežno zadevala zdravljenje z režimi, ki vsebujejo zidovudin.
English: Dolutegravir had no Pharmacodynamic effect on Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and progesterone.
Slovenian: Dolutegravir ni imel farmakodinamičnega učinka na luteinizirajoči hormon (LH), folitropin (FSH) in progesteron.
English: There are limited data available on the use of dolutegravir, abacavir and lamivudine in patients aged 65 years and over.
Slovenian: Na voljo so omejeni podatki o uporabi dolutegravirja, abakavirja in lamivudina pri bolnikih, starih 65 let ali več.
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;
English: STRIIVING (201147) is a 48-week, randomized, open-label, active controlled, multicenter, noninferiority study in patients without any prior treatment failure, and without any documented resistance to any class.
Slovenian: STRIIVING (201147) je 48-tedenska, randomizirana, odprta, z zdravilno učinkovino nadzorovana, multicentrična študija neinferiornosti pri bolnikih brez kakšnega neuspeha predhodnega zdravljenja in brez dokumentirane odpornosti proti kateri koli skupini.
English: If you have stopped taking Triumeq for any reason - especially because you think you are having side effects, or because you have other illness:
Slovenian: Če ste zdravilo Triumeq prenehali jemati zaradi kakršnega koli razloga - še zlasti, če menite, da imate neželene učinke, ali ker imate druge bolezni:
English: It is unknown if all or part of this is due to unabsorbed active substance or biliary excretion of the glucuronidate conjugate, which can be further degraded to form the parent compound in the gut lumen.
Slovenian: Ni znano, ali je vsa ta količina ali pa samo njen del neabsorbirana zdravilna učinkovina ali pa je posledica biliarnega izločanja glukuronidnega konjugata, ki se v črevesni svetlini razgradi, tako da nastane izhodna spojina.
English: The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5'-carboxylic acid and 5'-glucuronide which account for about 66% of the administered dose.
Slovenian: Pri človeku se abakavir v glavnem presnavlja z alkoholno dehidrogenazo in glukuronidacijo, pri čemer nastane 5'-karboksilna kislina in 5'-glukuronid, ki predstavljata približno 66% prejetega odmerka.
English: Some people taking Triumeq or other combination treatments for HIV are more at risk of serious side effects than others.
Slovenian: Pri nekaterih ljudeh, ki jemljejo zdravilo Triumeq ali druga kombinirana zdravila za zdravljenje okužbe z virusom HIV, obstaja večje tveganje za pojav resnih neželenih učinkov kot pri drugih.
English: HLA-B*5701 screening for risk of ABC hypersensitivity should never be substituted for appropriate clinical vigilance and patient management in individuals receiving ABC.
Slovenian: Presejanje za prisotnosti HLA-B*5701 za ugotavljanje tveganja preobčutljivostne reakcije na ABC ne sme nikoli nadomestiti ustreznega kliničnega nadzora in vodenja bolnika pri posameznikih, ki prejemajo ABC.
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, Pglycoprotein (P-gp), and breast cancer resistance protein (BCRP).
Slovenian: Dolutegravir je tudi substrat UGT1A3, UGT1A9, CYP3A4, P-glikoproteina (P-gp) in proteina odpornosti pri raku dojke (BCRP).
English: Virologic non response† No virologic data at Weeks 48 window
Slovenian: Virološki neodziv† V 48. tednu ni viroloških podatkov
English: In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. metformin) (see Table 1).
Slovenian: In vivo lahko dolutegravir zviša plazemske koncentracije zdravil, katerih izločanje je odvisno od OCT2 ali MATE-1 (npr. metformin) (glejte Preglednico 1).
English: Abacavir and lamivudine triphosphates show significantly less affinity for host cell DNA polymerases.
Slovenian: Abakavir in lamivudin trifosfat imata občutno manjšo afiniteto do DNK polimeraz gostiteljske celice.
English: Similar studies were not conducted with either abacavir or lamivudine.
Slovenian: Podobnih študij, bodisi z abakavirjem bodisi z lamivudinom niso, izvajali.
English: The combination of abacavir and lamivudine has demonstrated antiviral activity in cell culture against non-subtype B isolates and HIV-2 isolates with equivalent antiviral activity as for subtype B isolates.
Slovenian: Kombinacija abakavirja in lamivudina je v celični kulturi delovala protivirusno proti izolatom podtipa ne-B in izolatom HIV-2 z enakovredno protivirusno aktivnostjo kot pri izolatih podtipa B.
English: • a decreased number of cells involved in blood clotting (thrombocytopenia).
Slovenian: • zmanjšano število celic, ki sodelujejo pri strjevanju krvi (trombocitopenija)
English: Triumeq contains dolutegravir, abacavir and lamivudine, therefore any interactions identified for these individually are relevant to Triumeq.
Slovenian: Zdravilo Triumeq vsebuje dolutegravir, abakavir in lamivudin, zato je katera koli interakcija, povezana s posamezno zdravilno učinkovino, relevantna tudi za zdravilo Triumeq.
English: Antidiabetics Metformin/Dolutegravir
Slovenian: Antidiabetiki metformin/dolutegravir metformin dolutegravir
English: If you have discontinued Triumeq due to this reaction, YOU MUST NEVER TAKE Triumeq, or any medicine containing abacavir again as within hours you may experience a life-threatening lowering of your blood pressure or death.
Slovenian: Če ste zdravilo Triumeq nehali jemati zaradi te reakcije, NE SMETE NIKOLI VEČ VZETI tega zdravila ali katerega koli zdravila, ki vsebuje abakavir, saj lahko v nekaj urah pride do življenjsko nevarnega znižanja krvnega tlaka ali smrti.
English: Hypersensitivity case studies
Slovenian: Študije primerov preobčutljivosti
English: Both abacavir and lamivudine are metabolised sequentially by intracellular kinases to the respective 5'-triphosphates (TP) which are the active moieties with extended intracellular half-lives supporting once daily dosing (see section 5.2).
Slovenian: Oba, tako abakavir kot lamivudin, se dosledno presnavljata z znotrajceličnimi kinazami v ustrezne 5'-trifosfate (TP), ki so aktivne oblike s podaljšano znotrajcelično razpolovno dobo, kar omogoča odmerjanje enkrat na dan (glejte poglavje 5.2).
English: In this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Slovenian: Pri tej bolezni deli kostnega tkiva odmrejo zaradi zmanjšane prekrvitve kosti.
English: HLA-B*5701 is the only identified pharmacogenetic marker that is consistently associated with clinical diagnosis of an ABC HSR reaction.
Slovenian: Prisotnost alela HLA-B*5701 je edini znani farmakogenetski označevalec, ki je dosledno povezan s klinično diagnozo preobčutljivostne reakcije na ABC.
English: The efficacy of Triumeq in HIV-infected, therapy naive subjects is based on the analyses of data from a number of trials.
Slovenian: Učinkovitost zdravila Triumeq pri predhodno nezdravljenih osebah, okuženih z virusom HIV, temelji na analizi podatkov številnih preskušanj.
English: The systemic exposure at the no effect level in mice and rats was equivalent to 3 and 7 times the human systemic exposure during therapy.
Slovenian: Sistemska izpostavljenost, ki na miših in podganah ni imela še nobenega karcinogenega učinka, je bila ekvivalentna 3-kratni oziroma 7kratni sistemski izpostavljenosti med zdravljenjem človeka.
English: If you get any symptoms of infection and inflammation or if you notice any of the symptoms above: → Tell your doctor immediately.
Slovenian: Če se pri vas pojavijo simptomi okužbe in vnetja ali če opazite katerega od zgoraj naštetih simptomov:
English: Clinically it is not possible to determine whether a HSR with Triumeq would be caused by abacavir or dolutegravir.
Slovenian: Klinično ni mogoče ugotoviti ali bi reakcijo pri zdravilu Triumeq povzročil abakavir ali dolutegravir.
English: Abacavir is metabolised by UGT (UGT2B7) and alcohol dehydrogenase; co-administration of inducers (e.g. rifampicin, carbamazepine and phenytoin) or inhibitors (e.g. valproic acid) of UGT enzymes or with compounds eliminated through alcohol dehydrogenase could alter abacavir exposure.
Slovenian: Abakavir se presnavlja z UGT (UGT2B7) in alkoholno dehidrogenazo; sočasna uporaba induktorjev (npr. rifampicina, karbamazepina in fenitoina) ali zaviralcev (npr. valprojske kisline) encimov UGT ali s sestavinami, ki se izločajo z alkoholno dehidrogenazo, lahko spremeni izpostavljenost abakavirju.
English: Other signs and symptoms that have been observed as part of abacavir HSR are described in detail in section 4.8 (Description of selected adverse reactions), including respiratory and gastrointestinal symptoms.
Slovenian: Drugi znaki in simptomi, ki so jih opazili v sklopu preobčutljivostnih reakcij na abakavir in so podrobno opisani v poglavju 4.8 (Opis izbranih neželenih učinkov), vključujejo respiratorne in gastrointestinalne simptome.
English: In patients with prior failed therapies, but naïve to the integrase class (SAILING study), integrase inhibitor substitutions were observed in 4/354 patients (follow-up 48 weeks) treated with dolutegravir, which was given in combination with an investigator selected background regimen (BR).
Slovenian: Pri bolnikih s predhodno neuspešnimi terapijami, ki pa še niso bili zdravljeni z zdravili iz skupine zaviralcev integraz (študija SAILING), so substitucije zaviralcev integraz opazili pri 4/354 bolnikov (spremljanje 48 tednov), zdravljenih z dolutegravirjem v kombinaciji z osnovno shemo (OS), ki jo je izbral raziskovalec.
English: In serial passage with strain NL432-based site directed mutants at N155H or E92Q, no further selection of resistance was seen (fold change unchanged around 1).
Slovenian: V zaporednem prehodu s sevom NL432, začenši s točkovnimi mutanti, ki vključujejo N155H ali E92Q, ni bilo opaziti nadaljnje selekcije odpornosti (sprememba občutljivosti nespremenjena, okoli 1).
English: The median time to viral suppression was shorter with ABC/3TC + DTG (28 vs 84 days, p<0.0001).
Slovenian: Mediana časa do virusne supresije v skupini, ki je prejemala ABC/3TC + DTG, je bila krajša (28 proti 84 dni, p<0,0001).
English: Triumeq can be taken with or without food.
Slovenian: Zdravilo Triumeq se lahko vzame s hrano ali brez nje.
English: Before you are prescribed Triumeq your doctor will arrange a test to find out whether you carry a particular type of gene called HLA-B*5701.
Slovenian: Preden vam bodo predpisali zdravilo Triumeq, bo vaš zdravnik opravil testiranje, da ugotovi ali ste morda nosilec gena, ki se imenuje HLA-B*5701.
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: Na podlagi in vivo in/ali in vitro podatkov ni pričakovati, da bi dolutegravir vplival na farmakokinetiko zdravil, ki so substrati glavnih encimov ali prenašalcev, kot so CYP3A4, CYP2C9 in P-gp (za več informacij glejte poglavje
English: • Extreme tiredness or achiness or generally ill feeling
Slovenian: • huda utrujenost ali bolečnost ali splošno slabo počutje