FrancophonIA/ELRC3.0 huggingface dataset:
English: In ARIA (ING117172), a randomized, open-label, active-controlled, multicenter, parallel group, noninferiority study; 499 HIV-1 infected ART naïve adult women were randomized 1:1 to receive either; DTG/ABC/3TC FDC 50 mg/600 mg/300 mg; or atazanavir 300 mg plus ritonavir 100 mg plus tenofovir disproxil / emtricitabine 245 mg/200 mg (ATV+RTV+TDF/FTC FDC), all administered once daily.
Slovenian: Zajela je 499 odraslih žensk, ki so bile okužene s HIV-1 in še niso prejemale ART. Udeleženke so v razmerju 1:1 randomizirali na prejemanje bodisi DTG/ABC/3TC FDC 50 mg/600 mg/300 mg bodisi 300 mg atazanavirja, 100 mg ritonavirja in 245 mg/200 mg dizoproksiltenofovirat/emtricitabina (ATV+RTV+TDF/FTC FDC), vse enkrat na dan.
English: The antiviral activity of abacavir in cell culture was not antagonized when combined with the nucleoside reverse transcriptase inhibitors (NRTIs) didanosine, emtricitabine, lamivudine, stavudine, tenofovir, zalcitabine or zidovudine, the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine, or the protease inhibitor (PI) amprenavir.
Slovenian: Kombinacija z nukleozidnimi zaviralci reverzne transkriptaze (NRTI) didanozinom, emitricitabinom, lamivudinom, stavudinom, tenofovirjem, zalcitabinom ali zidovudinom, zaviralcem ne-nukleozidne reverzne transkriptaze (NNRTI) nevirapinom ali zaviralcem proteaze (PI) amprenavirjem ni imela antagonističnega učinka na protivirusno aktivnost abakavirja.
English: If you have stopped taking Triumeq because of a hypersensitivity reaction, you must NEVER AGAIN take Triumeq, or any other medicine containing abacavir.
Slovenian: Če ste zdravilo Triumeq nehali jemati zaradi preobčutljivostne reakcije, ne smete NIKOLI VEČ vzeti zdravila Triumeq; prav tako ne smete nikoli več vzeti katerega koli drugega zdravila, ki vsebuje abakavir.
English: You should never take abacavir or abacavircontaining products again if you have a hypersensitivity reaction: it can be life threatening.
Slovenian: Če imate preobčutljivostno reakcijo, ne smete nikoli več vzeti abakavirja ali zdravil, ki vsebujejo abakavir: preobčutljivostna reakcija je lahko življenjsko nevarna.
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: Triumeq is not recommended in patients with moderate to severe hepatic impairment (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih z zmerno do hudo jetrno okvaro uporaba zdravila Triumeq ni priporočljiva (glejte poglavji 4.2 in 5.2).
English: Combination therapy such as Triumeq may cause other conditions to develop during HIV treatment.
Slovenian: Drugi možni neželeni učinki kombiniranega zdravljenja okužbe z virusom HIV Kombinirana terapija, kot je zdravilo Triumeq, lahko med zdravljenjem HIV povzroči nastanek drugih bolezenskih stanj.
English: In vitro, abacavir did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrates no or weak inhibition of OATP1B1, OAT1B3, OCT1, OCT2, BCRP and P-gp or
Slovenian: In vitro abakavir ni zaviral ali induciral encimov CYP (npr. CYP3A4, CYP2C9 ali CYP2D6) in ni zaviral ali je le šibko zaviral OATP1B1, OAT1B3, OCT1, OCT2, BCRP in P-gp ali MATE2-K.
English: DTG 50 mg once daily + 2 NRTI N=411
Slovenian: DTG 50 mg enkrat na dan + 2 NRTI N=411
English: OTHER SPECIAL WARNING(S), IF NECESSARY Detach enclosed Alert Card, it contains important safety information.
Slovenian: Odtrgajte priloženo Opozorilno kartico za bolnika, ki vsebuje pomembne informacije o varnosti.
English: Renal impairment Triumeq is not recommended for use in patients with a creatinine clearance < 50 ml/min (see section
Slovenian: Zdravila Triumeq ni priporočljivo uporabljati pri bolnikih s kreatininskim očistkom < 50 ml/min (glejte poglavje 5.2).
English: • Nausea or vomiting or diarrhoea or abdominal pain
Slovenian: • navzea ali bruhanje ali driska ali bolečine v trebuhu
English: No dose adjustment is necessary when Triumeq is combined with nucleoside reverse transcript inhibitors.
Slovenian: Kadar se zdravilo Triumeq uporablja v kombinaciji z nukleozidnimi zaviralci reverzne transkriptaze prilagajanje odmerka ni potrebno.
English: - After stopping treatment with Triumeq for reasons of a suspected HSR, Triumeq or any other medicinal product containing abacavir or dolutegravir must never be re-initiated.
Slovenian: - Po ukinitvi zdravljenja z zdravilom Triumeq zaradi suma na preobčutljivostno reakcijo se zdravljenja z zdravilom Triumeq ali katerim koli drugim zdravilom, ki vsebuje abakavir ali dolutegravir, ne sme nikoli več ponovno uvesti.
English: Special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
Slovenian: Zaradi starostnih sprememb, npr. zmanjšanega delovanja ledvic in sprememb hematoloških parametrov, pa se pri tej starostni skupini priporoča posebna previdnost.
English: Table 5: Demographics and Week 48 virologic outcomes of randomized treatment of FLAMINGO (snapshot algorithm)
Slovenian: Preglednica 5: Demografski podatki in po 48 tednih virološki izid randomiziranega zdravljenja v študijii FLAMINGO (»snapshot« algoritem)
English: Virologic Outcomes of Randomized Treatment of SINGLE at 48 Weeks (Snapshot algorithm)
Slovenian: Preglednica 3: Virološki izid randomiziranega zdravljenja v študiji SINGLE po 48 tednih (»snapshot« algoritem)
English: • stomach (abdominal) discomfort
Slovenian: • nelagodje v želodcu (abdominalno)
English: Based on data obtained for abacavir, Triumeq is not recommended in patients with moderate and severe hepatic impairment.
Slovenian: Na osnovi podatkov, pridobljenih za abakavir, pri bolnikih z zmerno do hudo jetrno okvaro uporaba zdravila Triumeq ni priporočljiva.
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 (50 times the 50 mg human clinical exposure when administered in combination with abacavir and lamivudine based on AUC).
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 (50-kratnik klinične izpostavljenosti pri človeku, kadar se daje odmerek 50 mg v kombinaciji z abakavirjem in lamivudinom, na podlagi AUC).
English: anorexia1
Slovenian: 1, anemija
English: What Triumeq contains - The active substances are dolutegravir, abacavir and lamivudine.
Slovenian: Kaj vsebuje zdravilo Triumeq - Zdravilne učinkovine so dolutegravir, abakavir in lamivudin.
English: Dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% Rilpivirine ↔
Slovenian: rilpivirin dolutegravir AUC  12% Cmax  13% Cτ  22% rilpivirin 
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: Since the recommended dose of dolutegravir is 50 mg twice daily for patients with resistance to integrase inhibitors, the use of Triumeq is not recommended for patients with integrase inhibitor resistance.
Slovenian: Ker je priporočeni odmerek dolutegravirja pri bolnikih z odpornostjo na zaviralce integraze 50 mg dvakrat dnevno, uporaba zdravila Triumeq pri bolnikih z odpornostjo na zdravila iz skupine zaviralcev integraze ni priporočljiva.
English: ABC HSR educational material for health care professionals
Slovenian: • Povzetek glavnih značilnosti zdravila • Izobraževalno gradivo o preobčutljivosti za ABC za zdravstvene delavce
English: Each pack of 30 film-coated tablets contains a desiccant.
Slovenian: V vsaki plastenki s 30 filmsko obloženimi tabletami je sušilno sredstvo.
English: Before initiating abacavir therapy, clinicians should screen for HLA-B*5701.
Slovenian: Pred uvedbo zdravljenja z abakavirjem morajo zdravniki izvesti presejanje za HLA-B*5701.
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: If you are breast-feeding, or thinking about breast-feeding:
Slovenian: Če dojite ali nameravate dojiti:
English: In reproductive toxicity studies in animals, dolutegravir, lamivudine and abacavir were shown to cross the placenta.
Slovenian: Študije vpliva na sposobnost razmnoževanja pri živalih so pokazale, da dolutegravir, lamivudin in abakavir prehajajo skozi placento.
English: De novo resistance was not detected to the integrase class or the NRTI class in any patients who were treated with dolutegravir + abacavir/lamivudine in the three studies mentioned.
Slovenian: Pri nobenem od bolnikov, zdravljenih z dolutegravirjem + abakavirjem/lamivudinom v navedenih treh študijah, niso opazili na novo nastale odpornosti na zdravila iz skupine integraz ali iz skupine NRTI.
English: CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Triumeq if:
Slovenian: TAKOJ SE POSVETUJTE S SVOJIM ZDRAVNIKOM, ali morate morda prenehati z jemanjem zdravila, če:
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.74 times the 50mg human clinical exposure when administered in combination with abacavir and lamivudine based on AUC).
Slovenian: Peroralna uporaba dolutegravirja pri brejih kunčjih samicah v odmerkih do 1000 mg/kg na dan od 6. do 18. dne gestacije ni povzročila razvojnih toksičnih učinkov ali teratogenih učinkov (0,74-kratnik klinične izpostavljenosti pri človeku, kadar se daje odmerek 50 mg v kombinaciji z abakavirjem in lamivudinom, na podlagi AUC).
English: Asymptomatic creatine phosphokinase (CPK) elevations mainly in association with exercise have also been reported with dolutegravir therapy.
Slovenian: Pri zdravljenju z dolutegravirjem so poročali tudi o asimptomatskem povišanju vrednosti kreatinfosfokinaze (CPK), predvsem v povezavi z vadbo.
English: HIV-1 RNA <50 copies/mL for those on ABC/3TC * Adjusted for baseline stratification factors.
Slovenian: HIV-1 RNA <50 kopij/ml pri tistih z ABC/3TC Mediana časa do virusne supresije**
English: Renal impairment Pharmacokinetic data have been obtained for dolutegravir, lamivudine and abacavir separately.
Slovenian: Okvara ledvic Farmakokinetični podatki so bili pridobljeni za dolutegravir, lamivudin in abakavir posamezno.
English: Regardless of HLA-B*5701 status, patients who are diagnosed with a hypersensitivity reaction must discontinue abacavir immediately.
Slovenian: Obravnava pri pojavu preobčutljivostne reakcije na ABC Ne glede na status HLA-B*5701 morajo bolniki, pri katerih je ugotovljena preobčutljivostna reakcija, nemudoma prenehati z jemanjem abakavirja.
English: Lamivudine: AUC ↑43% Cmax ↑7%
Slovenian: AUC  43% Cmax  7%
English: The clinical status of the patient and the adverse reaction profile of Triumeq should be borne in mind when considering the patient's ability to drive or operate machinery.
Slovenian: Pri presojanju bolnikovih sposobnosti za vožnjo in upravljanje s stroji je potrebno upoštevati tako klinično stanje bolnika kot možne neželene učinke zdravila Triumeq.
English: Since the dose of dolutegravir is 50 mg twice daily when co-administered with efavirenz, the co-administration of efavirenz with Triumeq is not recommended (see section 4.4).
Slovenian: Ker je pri sočasnem dajanju z efavirenzom odmerek dolutegravirja 50 mg dvakrat dnevno, se sočasna uporaba efavirenza z zdravilom Triumeq ne priporoča (glejte poglavje 4.4).
English: Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Slovenian: Abakavirja se ne sme uporabljati pri bolnikih, ki so potrjeni nosilci alela HLA-B*5701.
English: 13.4 g)/Lamivudine oral solution 300 mg Lamivudine:
Slovenian: Enkraten odmerek lamivudina 300 mg peroralne raztopine lamivudin:
English: - HLA-B*5701 status must always be documented prior to initiating therapy.
Slovenian: Zato je treba vselej upoštevati naslednje: - pred uvedbo terapije je treba vedno dokumentirati status HLA-B*5701.
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with carbamazepine, DTG/ABC/3TC FDC is not recommended for patients taking carbamazepine.
Slovenian: Ker je priporočeni odmerek dolutegravirja med sočasno uporabo s karbamazepinom 50 mg dvakrat na dan, DTG/ABC/3TC FDC ni priporočljivo uporabljati pri bolnikih, ki jemljejo karbamazepin.
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers, DTG/ABC/3TC FDC is not recommended for patients taking these metabolic inducers.
Slovenian: Ker je priporočeni odmerek dolutegravirja med sočasno uporabo s temi induktorji presnove 50 mg dvakrat na dan, DTG/ABC/3TC FDC ni priporočljivo uporabljati pri bolnikih, ki jemljejo te induktorje presnove.
English: At 144 weeks in the open-label phase of SINGLE, virologic suppression was maintained, the DTG +ABC/3TC arm (71%) was superior to the EFV/TDF/FTC arm (63%), treatment difference was 8.3% (2.0, 14.6).
Slovenian: Skupina, zdravljena s kombinacijo DTG + ABC/3TC (71 %), je bila superiorna skupini, zdravljeni s kombinacijo EFV/TDF/FTC (63 %); razlika med zdravljenjema je bila 8,3 %
English: Seven hundred and five raltegravir resistant isolates from raltegravir experienced patients were analyzed for susceptibility to dolutegravir.
Slovenian: Za določanje občutljivosti na dolutegravir so analizirali 705 na raltegravir odpornih izolatov bolnikov, ki so že prejemali raltegravir.
English: 30% of the body surface (toxic epidermal necrolysis)
Slovenian: (toksična epidermalna nekroliza)
English: The observed values of the peak concentrations are 9-fold greater than the IC50 of abacavir of 0.08 µg/ml or 0.26 µM when abacavir is given at 600 mg twice daily.
Slovenian: Če se abakavir daje v odmerku 600 mg dvakrat dnevno, so opazovane vrednosti največjih koncentracij 9-krat večje od IC50 abakavirja (0,08 µg/ml ali 0,26 µM).
English: Malignant tumours occurred in the preputial gland of males and the clitoral gland of females of both species, and in rats in the thyroid gland of males and in the liver, urinary bladder, lymph nodes and the subcutis of females.
Slovenian: Maligni tumorji so se pri samcih obeh vrst pojavljali na prepucionalnih žlezah, pri samicah obeh vrst pa na žlezah klitorisa.
English: EFV/TDF/FTC = efavirenz 600 mg, tenofovir disoproxil 245 mg, emtricitabine 200 mg in the form of Atripla FDC.
Slovenian: Opombe: ABC/3TC = abakavir 600 mg, lamivudin 300 mg v obliki kombiniranega fiksnega odmerka kombinacije (FDC) zdravil Kivexa/Epzicom EFV/TDF/FTC = efavirenz 600 mg, dizoproksiltenofovirat 245 mg, emtricitabin 200 mg v obliki Atripla FDC.
English: If the doctor thinks they may have been, you will then be told never again to take Triumeq, or any other medicine containing abacavir.
Slovenian: Če zdravnik oceni, da so morda povezani, vam bo naročil, da ne smete nikoli več jemati zdravila Triumeq ali drugih zdravil, ki vsebujejo abakavir ali dolutegravir.
English: AE = Adverse event.
Slovenian: NU = neželen učinek.
English: Hepatic impairment Pharmacokinetic data has been obtained for dolutegravir, abacavir and lamivudine separately.
Slovenian: Okvara jeter Farmakokinetični podatki so bili pridobljeni za dolutegravir, abakavir in lamivudin posamezno.
English: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6%
Slovenian: Kortikosteroidi prednizon dolutegravir AUC  11% Cmax  6%
English: Myalgia, rarely myolysis, arthralgia, elevated creatine phosphokinase
Slovenian: Mišično-skeletni pojavi mišične bolečine, redkeje mioliza, bolečine v sklepih, zvišane vrednosti kreatin-fosfokinaze
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/940/002
Slovenian: EU/1/14/940/001 EU/1/14/940/002
English: NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg tablets dolutegravir/abacavir/lamivudine
Slovenian: Triumeq 50 mg/600 mg/300 mg tablete dolutegravir/abakavir/lamivudin
English: Dolutegravir was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Slovenian: Dolutegravir v študijah in vitro na bakterijah in gojenih sesalskih celicah ter v mikronukleus testu izvedenem in vivo na glodalcih ni bil mutagen ali klastogen.
English: HIV-1 RNA <50 copies/mL by baseline covariates
Slovenian: HIV-1 RNA <50 kopij/ml pri tistih z ABC/3TC
English: Triumeq can make you dizzy and have other side effects that make you less alert.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Triumeq lahko povzroči omotico in ima druge neželene učinke, ki lahko zmanjšajo zbranost.
English: No antagonistic effects in vitro were seen with lamivudine and other antiretrovirals (tested agents: abacavir, didanosine, nevirapine, zalcitabine, and zidovudine).
Slovenian: Pri testiranju lamivudina in drugih protivirusnih zdravil (abakavirja, didanozina, nevirapina, zalcitabina in zidovudina) in vitro niso opazili nobenih antagonističnih učinkov.
English: Many of the adverse reactions listed in the table below occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity.
Slovenian: Številni neželeni učinki, ki so navedeni v spodnji preglednici, se pri bolnikih s preobčutljivostjo na abakavir pojavijo pogosto (navzea, bruhanje, diareja, povišana telesna temperatura, letargija, eksantem).
English: insomnia
Slovenian: nespečnost
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) film-coated tablets
Slovenian: Skupno pakiranje: 90 (3 pakiranja po 30) filmsko obloženih tablet.
English: Following a single dose of 600 mg of abacavir, the mean (CV) Cmax is 4.26 µg/ml (28%) and the mean (CV)
Slovenian: Po vnosu abakavirja v enkratnem 600 mg odmerku znaša srednja (CV) Cmax 4,26 µg/ml (28%) in srednja (CV) AUC 11,95 µg.h/ml (21%).
English: No clinically important pharmacokinetic differences between subjects with severe renal impairment (CLcr <30 mL/min) and matching healthy subjects were observed.
Slovenian: Med preiskovanci s hudo okvaro ledvic (Clcr <30 ml/min) in zdravimi kontrolnimi osebami niso opazili klinično pomembnih razlik v farmakokinetiki.
English: nausea, diarrhoea
Slovenian: omotica, zaspanost, letargija
English: Dolutegravir ↑ AUC ↑ 91% Cmax ↑ 50% Cτ ↑ 180%
Slovenian: Zaviralci proteaze atazanavir/dolutegravir dolutegravir AUC  91% Cmax  50% C  180%
English: How to store Triumeq
Slovenian: Shranjevanje zdravila Triumeq
English: Late Switch ABC/DTG/3TC FDC N=244 n (%)
Slovenian: Pozni prehod ABC/DTG/3TC FDC N = 244 n (%)
English: NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg film-coated tablets dolutegravir/abacavir/lamivudine
Slovenian: Triumeq 50 mg/600 mg/300 mg filmsko obložene tablete dolutegravir/abakavir/lamivudin
English: Dolutegravir ↔ (Not studied)
Slovenian: nelfinavir/dolutegravir dolutegravir (ni raziskano)
English: If the doctor thinks they may be related to a hypersensitivity reaction, you will be told never again to take Triumeq, or any other medicine containing abacavir or dolutegravir.
Slovenian: Če bo ocenil, da so morda povezani s preobčutljivostno reakcijo, vam bo naročil, da ne smete nikoli več jemati zdravila Triumeq ali katerega koli drugega zdravila, ki vsebuje abakavir.
English: If you notice any of these symptoms: → Tell your doctor.
Slovenian: Če opazite katerega od teh simptomov,
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with St. John's wort, DTG/ABC/3TC FDC is not recommended.
Slovenian: Ker je priporočeni odmerek dolutegravirja med sočasno uporabo s šentjanževko 50 mg dvakrat na dan, uporaba DTG/ABC/3TC FDC ni priporočljiva.
English: Very rare side effects that may show up in blood tests are: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Slovenian: • nesposobnost kostnega mozga, da proizvaja nove rdeče krvne celice (čista aplazija rdečih krvničk).
English: Abacavir was not significantly metabolised by CYP enzymes.
Slovenian: Encimi CYP niso bistveno sodelovali pri presnovi abakavirja.
English: No dose adjustment of oral contraceptives is necessary when co-administered with Triumeq.
Slovenian: Pri sočasni uporabi z zdravilom Triumeq prilagajanje odmerka peroralnih kontraceptivov ni potrebno.
English: Separate preparations of dolutegravir, abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated.
Slovenian: V primeru indikacije za ukinitev ali prilagoditev odmerka ene izmed zdravilnih učinkovin so na voljo ločena zdravila z dolutegravirjem, abakavirjem ali lamivudinom.
English: No relevant effects were seen on the QTc interval, with doses of dolutegravir exceeding the clinical dose by approximately 3-fold.
Slovenian: Pri odmerkih, ki presegajo klinični odmerek dolutegravirja za približno 3-krat, ni bilo opaziti pomembnih vplivov na interval QTc.
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets.
Slovenian: 30 filmsko obloženih tablet.
English: Table 6: Demographics and Week 48 virologic outcomes of randomized treatment of ARIA (snapshot algorithm)
Slovenian: Preglednica 6: Demografski podatki in virološki izidi randomiziranega zdravljenja v študiji ARIA po 48 tednih (»snapshot« algoritem)
English: There are no data available on the effects of the combination of dolutegravir, abacavir and lamivudine in animals, except a negative in vivo rat micronucleus test which tested the effects of the combination of abacavir and lamivudine.
Slovenian: Z izjemo negativnega mikronukleus testa, izvedenega in vivo na podganah, s katerim so testirali učinke kombinacije abakavir in lamivudin, drugi podatki o učinkih kombinacije dolutegravir, abakavir in lamivudin na živalih niso na voljo.
English: Drug interactions
Slovenian: Interakcije
English: Lymphopenia
Slovenian: lopinavir 
English: Treatment with Triumeq must be stopped without delay if HSR cannot be ruled out on clinical grounds, and therapy with Triumeq or other abacavir or dolutegravir containing products must never be re-initiated.
Slovenian: Če se na podlagi kliničnih podatkov preobčutljivostne reakcije ne da izključiti, je treba terapijo z zdravilom Triumeq takoj ukiniti, zdravljenja s tem ali katerim koli drugim zdravilom, ki vsebujejo abakavir ali dolutegravir pa se ne sme nikoli ponovno uvesti.
English: A single dose of 50 mg of dolutegravir was administered to 8 subjects with moderate hepatic impairment (Child-Pugh class B) and to 8 matched healthy adult controls.
Slovenian: Osem preiskovancev z zmerno okvaro jeter (Child-Pugh B) in 8 usklajenih zdravih odraslih primerjalnih oseb, je prejelo enkratni odmerek 50 mg dolutegravirja.
English: Since the dose of dolutegravir is 50 mg twice daily when coadministered with nevirapine, the coadministration of nevirapine with Triumeq is not recommended.
Slovenian: Ker je pri sočasnem dajanju z nevirapinom odmerek dolutegravirja 50 mg dvakrat dnevno, se sočasna uporaba nevirapina z zdravilom Triumeq ne priporoča.
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir, the coadministration of tipranavir/ritonavir with Triumeq is not recommended.
Slovenian: Ker je pri sočasnem dajanju s tipranavirjem/ritonavirjem odmerek dolutegravirja 50 mg dvakrat dnevno, se sočasna uporaba tipranavirja/ritonavirja z zdravilom Triumeq ne priporoča.
English: Since the dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin, the co-administration of rifampicin with Triumeq is not recommended.
Slovenian: Ker je pri sočasnem dajanju z rifampicinom odmerek dolutegravirja 50 mg dvakrat dnevno, se sočasna uporaba rifampicina z zdravilom Triumeq ne priporoča.