FrancophonIA/ELRC3.0 huggingface dataset:
English: A moderate amount of data on pregnant women taking the individual actives abacavir and lamivudine in combination indicates no malformative toxicity (more than 400 outcomes from first trimester exposures).
Croatian: Umjerena količina podataka o trudnicama liječenima kombinacijom abakavira i lamivudina kao pojedinačnih djelatnih tvari ne ukazuje na malformacijsku toksičnost (više od 400 ishoda nakon izloženosti u prvom tromjesečju trudnoće).
English: Dolutegravir, abacavir and lamivudine are present in cerebrospinal fluid (CSF).
Croatian: Dolutegravir, abakavir i lamivudin pronađeni su u cerebrospinalnoj tekućini.
English: Marketing Authorisation Holder ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands.
Croatian: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Nizozemska
English: In dolutegravir Phase III studies patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN).
Croatian: U ispitivanja dolutegravira faze III mogli su biti uključeni bolesnici s istodobnom infekcijom hepatitisom B i/ili C, pod uvjetom da im nalazi pretraga biokemijskih pokazatelja jetrene funkcije na početku ispitivanja nisu bili viši od 5 puta iznad gornje granice normale (GGN).
English: A clinically relevant phenotypic cut-off value (fold change vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome.
Croatian: nije utvrđena; genotipska rezistencija bila je bolji pretkazatelj ishoda.
English: White HDPE (high density polyethylene) bottles closed with polypropylene child-resistant closures, with a polyethylene faced induction heat seal liner.
Croatian: Bijele boce od polietilena visoke gustoće (HDPE), zatvorene polipropilenskim zatvaračima sigurnim za djecu i polietilenskom zaštitnom folijom.
English: • Nausea or vomiting or diarrhoea or abdominal pain
Croatian: • mučnina ili povraćanje ili proljev ili bol u abdomenu
English: amylase elevations1
Croatian: povišene vrijednosti amilaze1
English: The mean time to maximal serum concentrations (tmax) is about 2 to 3 hours (post dose for tablet formulation), 1.5 hours and 1.0 hour for dolutegravir, abacavir and lamivudine, respectively.
Croatian: Srednja vrijednost vremena do postizanja maksimalnih koncentracija u serumu (tmax) iznosi približno 2 do 3 sata (nakon primjene lijeka u obliku tablete) za dolutegravir, 1,5 sati za abakavir te 1,0 sati za lamivudin.
English: Fertility studies in rats have shown that dolutegravir, abacavir and lamivudine have no effect on male or female fertility.
Croatian: Istraživanja plodnosti u štakora pokazala su da dolutegravir, abakavir i lamivudin ne utječu na plodnost mužjaka ni ženki.
English: Neutropenia1, anaemia1, thrombocytopenia1
Croatian: neutropenija1, anemija1, trombocitopenija1
English: Triumeq is recommended to be administered 2 hours before or 6 hours after these medicinal products (see section
Croatian: Preporučuje se primijeniti Triumeq 2 sata prije ili 6 sati nakon primjene tih lijekova (vidjeti dio 4.5).
English: No clinically significant drug interactions are expected between dolutegravir, abacavir and lamivudine.
Croatian: Ne očekuju se klinički značajne interakcije između dolutegravira, abakavira i lamivudina.
English: Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir.
Croatian: Probir se preporučuje i prije ponovnog uvođenja abakavira u bolesnika nepoznata HLA-B*5701 statusa koji su prethodno dobro podnosili abakavir.
English: Limited data are available in adolescents receiving a daily dose of 600 mg of abacavir and 300 mg of lamivudine.
Croatian: Dostupni su ograničeni podaci o primjeni dnevnih doza od 600 mg abakavira i 300 mg lamivudina u adolescenata.
English: The carcinogenic potential of a combination of dolutegravir, abacavir and lamivudine has not been tested.
Croatian: Kancerogeni potencijal kombinacije dolutegravira, abakavira i lamivudina nije ispitivan.
English: Pharmacokinetic data for dolutegravir, abacavir and lamivudine in subjects >65 years of age are limited.
Croatian: Farmakokinetički podaci za dolutegravir, abakavir i lamivudin u ispitanika starijih od 65 godina su ograničeni.
English: Triumeq should not be co-administered with polyvalent cation-containing antacids.
Croatian: Triumeq se ne smije primjenjivati istodobno s antacidima koji sadrže polivalentne katione.
English: Effect of other medicinal products on the pharmacokinetics of dolutegravir, abacavir and lamivudine
Croatian: Učinak drugih lijekova na farmakokinetiku dolutegravira, abakavira i lamivudina
English: If you have stopped taking Triumeq
Croatian: Ako ste prestali uzimati Triumeq
English: Animal studies indicate no effects of dolutegravir, abacavir or lamivudine on male or female fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala da dolutegravir, abakavir ili lamivudin utječu na plodnost mužjaka ili ženki (vidjeti dio 5.3).
English: These metabolites are excreted in the urine.
Croatian: Ti se metaboliti izlučuju u mokraću.
English: In vitro, dolutegravir demonstrated no direct, or weak inhibition (IC50>50 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, UGT1A1 or UGT2B7, or the transporters Pgp, BCRP, BSEP, organic anion transporting polypeptide 1B1 (OATP1B1), OATP1B3, OCT1, MATE2-K, multidrug resistance-associated protein 2 (MRP2) or MRP4.
Croatian: In vitro dolutegravir nije pokazao ni izravnu ni slabu inhibiciju (IC50 > 50 μM) enzima citokroma P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, UGT1A1 ili UGT2B7 niti prijenosnika P-gp, BCRP, BSEP, polipeptidnog prijenosnika organskih aniona 1B1 (engl. organic anion transporting polypeptide, OATP1B1), OATP1B3, OCT1, MATE2-K, proteina koji uzrokuje rezistenciju na veći broj lijekova 2 (engl. multidrug resistance-associated protein 2, MRP2) i MRP4.
English: The Triumeq pack includes an Alert Card, to remind you and medical staff about hypersensitivity reactions.
Croatian: Pakiranje lijeka Triumeq sadrži Karticu s upozorenjima, koja služi da Vas i zdravstvene radnike podsjeti na reakcije preosjetljivosti.
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of dolutegravir with metformin, to maintain glycaemic control.
Croatian: Potrebno je razmotriti prilagodbu doze metformina kod započinjanja ili prekidanja istodobne primjene dolutegravira i metformina, kako bi se održala kontrola glikemije.
English: § Includes reasons such as withdrew consent, loss to follow-up, protocol deviation.
Croatian: § Uključuje razloge poput povlačenja pristanka, gubitka iz praćenja, odstupanja od protokola.
English: The most common symptoms are: fever (high temperature) and skin rash.
Croatian: vrućica (visoka tjelesna temperatura) i kožni osip.
English: Even patients who don't have the HLAB*5701 gene may still develop a hypersensitivity reaction, described in this leaflet in the panel headed ‘Hypersensitivity reactions'.
Croatian: Čak i u bolesnika koji nemaju gen HLA-B*5701 može se razviti reakcija preosjetljivosti, koja se u ovoj Uputi opisuje u odlomku 'Reakcije preosjetljivosti'.
English: No antagonistic effects in vitro were seen with lamivudine and other antiretrovirals (tested agents: abacavir, didanosine, nevirapine, zalcitabine, and zidovudine).
Croatian: Nisu primijećeni antagonistički učinci in vitro kod primjene lamivudina i drugih antiretrovirotika (ispitivani lijekovi: abakavir, didanozin, nevirapin, zalcitabin i zidovudin).
English: Continued passage in increasing concentrations of drug resulted in selection for double RT mutants 65R/184V and 74V/184V or triple RT mutant 74V/115Y/184V.
Croatian: RT-a 65R/184V i 74V/184V ili trostrukog mutanta RT-a 74V/115Y/184V.
English: The STRIIVING study (201147), was a randomized, open-label, active-controlled, multicentre, noninferiority switch study in virologically suppressed subjects with no documented history of resistance to any class.
Croatian: Ispitivanje STRIIVING (201147) bilo je randomizirano, otvoreno, aktivno kontrolirano, multicentrično ispitivanje neinferiornosti uz prebacivanje na drugu terapiju, provedeno u ispitanika s virusnom supresijom koji u anamnezi nisu imali dokumentiranu rezistenciju ni na koji razred lijekova.
English: Mannitol (E421) Microcrystalline cellulose Povidone (K29/32) Sodium starch glycollate Magnesium stearate
Croatian: celuloza, mikrokristalična povidon (K29/32) natrijev škroboglikolat magnezijev stearat
English: Observational studies have shown an association between myocardial infarction and the use of abacavir.
Croatian: Opservacijska ispitivanja ukazala su na povezanost između infarkta miokarda i primjene abakavira.
English: The geometric mean terminal carbovir-TP intracellular half-life at steady-state was 20.6 hours, compared to the geometric mean abacavir plasma half-life of 2.6 hours.
Croatian: Geometrijska srednja vrijednost terminalnog unutarstaničnog poluvijeka karbovirtrifosfata u stanju dinamičke ravnoteže iznosila je 20,6 sati, dok je geometrijska srednja vrijednost poluvijeka abakavira u plazmi iznosila 2,6 sati.
English: Other symptoms include:
Croatian: Najčešći simptomi su:
English: Dolutegravir was non-inferior to raltegravir, including within the subset of patients with the abacavir/lamivudine background regimen.
Croatian: Dolutegravir je bio neinferioran u odnosu na raltegravir, uključujući i u podskupini bolesnika koji su primali abakavir/lamivudin kao osnovno liječenje.
English: There are no clinical study data on the effects of Triumeq in the paediatric population.
Croatian: Nema podataka o učincima lijeka Triumeq na pedijatrijsku populaciju iz kliničkih ispitivanja.
English: Daclatasvir did not change dolutegravir plasma concentration to a clinically relevant extent.
Croatian: Daklatazvir nije promijenio koncentraciju dolutegravira u plazmi u klinički značajnoj mjeri.
English: In vitro, dolutegravir was not a substrate of human OATP 1B1, OATP 1B3 or OCT 1.
Croatian: In vitro, dolutegravir nije bio supstrat za ljudski OATP1B1, OATP1B3 ili OCT1.
English: The clinical relevance of this finding has not been determined.
Croatian: Nije utvrđen klinički značaj tog nalaza.
English: Notes: ABC/3TC = abacavir 600 mg, lamivudine 300 mg in the form of Kivexa/Epzicom fixed dose combination (FDC)
Croatian: Napomene: ABC/3TC = abakavir 600 mg, lamivudin 300 mg u obliku kombinacije fiksnih doza Kivexa/Epzicom.
English: The Triumeq tablet has been shown to be bioequivalent to dolutegravir single entity tablet and abacavir/lamivudine fixed-dose combination tablet (ABC/3TC FDC) administered separately.
Croatian: Pokazalo se da je Triumeq tableta bioekvivalentna tableti koja sadrži dolutegravir kao jedinu djelatnu tvar i tableti s kombinacijom fiksnih doza abakavira/lamivudina (ABC/3TC) primijenjenima odvojeno.
English: Rechallenge can result in a more rapid and severe reaction, which can be fatal, therefore rechallenge is contraindicated.
Croatian: Ponovno uvođenje abakavira može dovesti do bržeg nastupa još teže reakcije, koja može imati smrtni ishod; stoga je ponovno uvođenje abakavira kontraindicirano.
English: The mean IC50 for abacavir against lab-strains of HIV-1IIIB and HIV-1HXB2 ranged from 1.4 to 5.8 µM.
Croatian: Srednja vrijednost IC50 abakavira za laboratorijske sojeve HIV-1IIIB i HIV-1HXB2 kretala se u rasponu od 1,4 do 5,8 µM.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited plasma protein binding in vitro (< 36%).
Croatian: Lamivudin pokazuje linearnu farmakokinetiku u rasponu terapijskih doza te se u ograničenoj mjeri veže za proteine u plazmi in vitro (< 36%).
English: Baseline demographics and outcomes are summarised in Table 4.
Croatian: Početne demografske značajke i ishodi sažeto su prikazani u Tablici 4.
English: Carefully read all the information about hypersensitivity reactions in Section 4.
Croatian: Pažljivo pročitajte sve informacije o reakcijama preosjetljivosti u dijelu 4.
English: No dose adjustment is necessary when Triumeq is combined with nucleoside reverse transcript inhibitors.
Croatian: Triumeq primjenjuje u kombinaciji s nukleozidnim inhibitorima reverzne transkriptaze.
English: The geometric mean terminal half-life of intracellular active moiety carbovirtriphosphate (TP) at steady-state is 20.6 hours.
Croatian: Geometrijska srednja vrijednost terminalnog poluvijeka unutarstanične djelatne tvari karbovirtrifosfata u stanju dinamičke ravnoteže iznosi 20,6 sati.
English: The median or mean IC50 values for lamivudine against lab-strains of HIV-1 ranged from 0.007 to 2.3 µM.
Croatian: Medijani ili srednje vrijednosti IC50 lamivudina za laboratorijske sojeve HIV-1 kretali su se u rasponu od 0,007 do 2,3 µM.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia), and metabolic disorders (hyperlactatemia, hyperlipasemia).
Croatian: Glavne prijavljene nuspojave su hematološki poremećaji (anemija, neutropenija) i metabolički poremećaji
English: Active renal secretion of lamivudine in the urine is mediated through the organic cation transporter (OCT) 2 and multidrug and toxin extrusion transporters (MATE1 and MATE2-K).
Croatian: U aktivnoj bubrežnoj sekreciji lamivudina u mokraću posreduju prijenosnik organskih kationa 2 (engl. organic cation transporter 2, OCT2) i prijenosnici za izlučivanje više lijekova i toksina (engl. multidrug and toxin extrusion transporters, MATE1 i
English: Plasma protein binding studies in vitro indicate that abacavir binds only low to moderately (~49%) to human plasma proteins at therapeutic concentrations.
Croatian: Ispitivanja vezivanja za proteine u plazmi in vitro pokazuju da se abakavir u terapijskim koncentracijama tek malo do umjereno (~49%) vezuje za proteine u plazmi ljudi.
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.
Croatian: † Uključuje ispitanike koji su prekinuli liječenje prije 48. tjedna zbog nedostatka ili gubitka djelotvornosti te ispitanike s ≥ 50 kopija unutar 48 tjedana.
English: The efficacy of Triumeq in HIV-infected, therapy naive subjects is based on the analyses of data from a number of trials.
Croatian: Djelotvornost lijeka Triumeq u bolesnika s HIV infekcijom koji prethodno nisu bili liječeni temelji se na analizi podataka prikupljenih u više ispitivanja.
English: Discontinued due to AE or death
Croatian: Prekid liječenja zbog nuspojave ili smrti
English: • an increase in triglycerides (type of fat) in the blood
Croatian: • povećanje razine šećera (glukoze) u krvi • povećanje razine triglicerida (jedne vrste masnoće) u krvi.
English: Concerning lamivudine, a large amount of data (more than 3000 outcomes from first trimester) indicates no malformative toxicity.
Croatian: Velika količina podataka o primjeni lamivudina (više od 3000 ishoda nakon izloženosti u prvom tromjesečju) ne ukazuje na malformacijsku toksičnost.
English: Risk of heart attack The possibility that abacavir increases the risk of having a heart attack cannot be excluded.
Croatian: Ne može se isključiti mogućnost da abakavir povećava rizik od srčanog udara.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, predominantly by renal clearance (> 70%) via the organic cationic transport system.
Croatian: 0,32 l/h/kg, a najvećim se dijelom odvija kroz bubrege (>70%) putem sustava organskih kationskih prijenosnika.
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 effect on lamivudine exposure in vivo.
Croatian: Dolutegravir je inhibitor OCT2 i MATE1; međutim, analiza podataka iz različitih ispitivanja pokazala je da su koncentracije lamivudina bile slične i uz istodobnu primjenu dolutegravira i bez njega, što ukazuje na to da dolutegravir ne utječe na izloženost lamivudinu in vivo.
English: Cmax ↑ 66% When co-administered with dolutegravir 50mg BID:
Croatian: Cmax ↑ 66% Kad se istodobno primjenjuje s dolutegravirom 50 mg dvaput na dan:
English: Since the recommended dose of dolutegravir is 50 mg twice daily for patients taking etravirine without boosted protease inhibitors, Triumeq is not recommended for patients taking etravirine without co-administration of atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir (see further below in table).
Croatian: S obzirom da je preporučena doza dolutegravira 50 mg dvaput na dan u bolesnika koji uzimaju etravirin bez pojačanih inhibitora proteaze, Triumeq se ne preporučuje bolesnicima koji uzimaju etravirin ako se istodobno ne primjenjuju atazanavir/ritonavir, darunavir/ritonavir ili lopinavir/ritonavir (vidjeti nastavak tablice).
English: Twenty out of 23 children and adolescents (87%) had >1 log10 c/mL decrease from Baseline in HIV-1 RNA or HIV-1 RNA <400 c/mL at Week 24.
Croatian: U 20 od 23 djece i adolescenata (87%) razina HIV-1 RNK nakon 24 tjedna smanjila se za >1 log10
English: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160mg/800mg once daily for 5 days/300mg single dose)
Croatian: Antiinfektivni lijekovi trimetoprim/sulfametoksazol (kotrimoksazol)/abakavir trimetoprim/sulfametoksazol (kotrimoksazol)/lamivudin (160 mg/800 mg jedanput na dan tijekom 5 dana/300 mg u jednokratnoj dozi)
English: Eesti GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@gsk.com
Croatian: GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@gsk.com
English: Methadone dosage adjustment likely not needed in majority of patients; occasionally methadone re-titration may be required.
Croatian: U većine bolesnika vjerojatno neće biti potrebno prilagođavati dozu metadona;
English: OTHER SPECIAL WARNING(S), IF NECESSARY Detach enclosed Alert Card, it contains important safety information.
Croatian: Odvojite priloženu Karticu s upozorenjima jer sadrži važne informacije o sigurnosti.
English: § Includes reasons such as withdrew consent, loss to follow-up, moved, protocol deviation.
Croatian: § Uključuje razloge poput povlačenja pristanka, gubitka iz praćenja, preseljenja, odstupanja od protokola.
English: GI intolerance in monkeys occurred at 30 times the human mg/kg equivalent dose (based on 50 kg human), and 11 times the human mg/m2 equivalent dose for a total daily clinical dose of 50 mg.
Croatian: Gastrointestinalna nepodnošljivost u majmuna javljala se nakon primjene doza koje su bile 30 puta veće od ekvivalentne doze u ljudi izražene u mg/kg (određeno na temelju osobe tjelesne težine 50 kg) te 11 puta veće od ekvivalentne doze u ljudi izražene u mg/m2 za ukupnu dnevnu kliničku dozu od 50 mg.
English: - HLA-B*5701 status must always be documented prior to initiating therapy.
Croatian: Stoga se uvijek treba pridržavati sljedećih smjernica: - Status HLA-B*5701 mora se uvijek dokumentirati prije početka liječenja.
English: Elimination of abacavir is via hepatic metabolism with subsequent excretion of metabolites primarily in the urine.
Croatian: Abakavir se eliminira jetrenim metabolizmom, nakon čega se njegovi metaboliti izlučuju prvenstveno u mokraću.
English: The individual preparations of abacavir and lamivudine have been investigated separately, and as a dual nucleoside backbone, in combination antiretroviral therapy to treat ART- naive and ARTexperienced HIV- infected paediatric patients (data available on the use of abacavir and lamivudine in infants less than three months are limited).
Croatian: Abakavir i lamivudin su ispitivani odvojeno kao pojedinačni pripravci, ali i kao dvojna osnovna nukleozidna terapija, u kombinaciji s antiretrovirusnom terapijom za liječenje pedijatrijskih bolesnika s HIV infekcijom, od kojih neki prethodno jesu primali antiretrovirotike, a neki nisu (dostupni su ograničeni podaci o primjeni abakavira i lamivudina u dojenčadi mlađe od tri mjeseca).
English: The safety and efficacy of Triumeq has not been established in patients with significant underlying liver disorders.
Croatian: Bolest jetre Sigurnost i djelotvornost lijeka Triumeq u bolesnika sa značajnim podležećim poremećajima jetre nisu ustanovljene.
English: Lamivudine-TP (an analogue for cytidine) and carbovir-TP (the active triphosphate form of abacavir, an analogue for guanosine) are substrates for and competitive inhibitors of HIV reverse transcriptase (RT).
Croatian: Lamivudintrifosfat (analog za citidin) i karbovirtrifosfat (aktivni trifosfatni oblik abakavira, analog za gvanozin) su supstrati za reverznu transkriptazu HIV-a i njezini kompetitivni inhibitori.
English: There have been reports of mitochondrial dysfunction in HIVnegative infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4).
Croatian: HIV-negativne dojenčadi koja je bila izložena nukleozidnim analozima in utero i/ili nakon rođenja (vidjeti dio 4.4).
English: However, some patients with a suspected ABC hypersensitivity reaction may not have the HLA-B*5701 allele.
Croatian: Međutim, neki bolesnici sa suspektnom reakcijom preosjetljivosti na abakavir ne moraju nužno nositi alel HLA-B*5701.
English: DTG 50 mg once daily + 2 NRTI
Croatian: DTG 50 mg jedanput na dan + 2 NRTI
English: The absorption of dolutegravir is reduced by certain anti-acid medicinal products (see Table 1).
Croatian: Određeni lijekovi antacidi smanjuju apsorpciju dolutegravira (vidjeti Tablicu 1).
English: Triumeq is not recommended in patients with moderate to severe hepatic impairment (see sections 4.2 and 5.2).
Croatian: Ne preporučuje se primjena lijeka Triumeq u bolesnika s umjerenim do teškim oštećenjem jetrene funkcije (vidjeti dijelove 4.2 i 5.2).
English: Each bottle contains 30 film-coated tablets and a desiccant.
Croatian: Jedna boca sadrži 30 filmom obloženih tableta i sredstvo za sušenje.
English: In toxicology studies abacavir was shown to increase liver weights in rats and monkeys.
Croatian: U toksikološkim se ispitivanjima pokazalo da abakavir povećava težinu jetre u štakora i majmuna.
English: Delay in stopping treatment with Triumeq after the onset of hypersensitivity may result in an immediate and life-threatening reaction.
Croatian: Odgađanje prekida liječenja lijekom Triumeq nakon pojave preosjetljivosti može uzrokovati trenutačnu i po život opasnu reakciju.
English: Data obtained in patients with moderate to severe hepatic impairment show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Croatian: Podaci prikupljeni u bolesnika s umjerenim do teškim oštećenjem jetrene funkcije pokazuju da disfunkcija jetre nema značajnog utjecaja na farmakokinetiku lamivudina.
English: Before initiating treatment with abacavir-containing products, screening for carriage of the HLAB*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4).
Croatian: Prije početka liječenja lijekovima koji sadrže abakavir, za svakog bolesnika s HIV infekcijom, bez obzira na rasno podrijetlo, potrebno je provesti probir kako bi se utvrdilo je li nositelj alela HLA-B*5701 (vidjeti dio 4.4).
English: • if you have a kidney problem → Talk to your doctor if any of these apply to you before using Triumeq.
Croatian: Ako se nešto od navedenoga odnosi na Vas, razgovarajte sa svojim liječnikom prije nego uzmete lijek Triumeq.
English: In reproductive toxicity studies in animals, dolutegravir, lamivudine and abacavir were shown to cross the placenta.
Croatian: Reproduktivna toksičnost Ispitivanja reproduktivne toksičnosti na životinjama pokazala su da dolutegravir, lamivudin i abakavir prolaze kroz placentu.
English: § Includes reasons such as protocol deviation, lost to follow up, and withdrew consent.
Croatian: § Uključuje razloge poput odstupanja od protokola, gubitka iz praćenja i povlačenja pristanka.
English: Sorbitol Sorbitol solution (3.2 g, 10.2 g, Single dose lamivudine When possible, avoid chronic
Croatian: Sorbitol otopina sorbitola (3.2 g, 10.2 g, 13.4 g)/lamivudin
English: Almost all HSR to abacavir will include fever and/or rash.
Croatian: Gotovo sve reakcije preosjetljivosti na abakavir bit će praćene vrućicom i/ili osipom.