FrancophonIA/ELRC3.0 huggingface dataset:
English: Similar IC50s were seen for clinical isolates without any major difference between subtypes; in a panel of 24 HIV-1 isolates of clades A, B, C, D, E, F and G and group O the mean IC50 value was 0.2 nM (range 0.02-2.14).
Croatian: viđene su i kod kliničkih izolata, bez većih razlika među podvrstama; na paleti od 24 izolata HIV-1 iz linija A, B, C, D, E, F i G te skupine
English: The pharmacokinetic properties of dolutegravir, lamivudine and abacavir are described below.
Croatian: Farmakokinetičke značajke dolutegravira, lamivudina i abakavira opisane su u nastavku.
English: Uncommon side effects that may show up in blood tests are:
Croatian: Rijetke nuspojave koje se mogu vidjeti u nalazima krvnih pretraga:
English: Table 6: Demographics and Week 48 virologic outcomes of randomized treatment of ARIA (snapshot algorithm)
Croatian: Tablica 6: Demografske značajke i virološki ishodi u 48. tjednu randomiziranog liječenja u ispitivanju ARIA (snapshot algoritam)
English: Dolutegravir ↔ (Not studied)
Croatian: nelfinavir/dolutegravir dolutegravir ↔ (nije ispitivano)
English: Late Switch ABC/DTG/3TC FDC N=244 n (%)
Croatian: Kasni prelazak na fiksnu kombinaciju ABC/DTG/3TC N=244 n (%)
English: Hypersensitivity case studies
Croatian: Prikaz slučajeva preosjetljivosti
English: DTG 50 mg once daily + 2 NRTI N=411
Croatian: DTG 50 mg jedanput na dan + 2 NRTI N=411
English: No specific symptoms or signs have been identified following acute overdose with dolutegravir, abacavir or lamivudine, apart from those listed as adverse reactions.
Croatian: Nakon akutnog predoziranja dolutegravirom, abakavirom ili lamivudinom nisu primijećeni nikakvi posebni simptomi ni znakovi, osim onih koji su navedeni kao nuspojave.
English: • Shortness of breath, sore throat or cough
Croatian: • nedostatak zraka, grlobolja ili kašalj
English: Rarely, patients who have stopped abacavir for reasons other than symptoms of HSR have also experienced life-threatening reactions within hours of re- initiating abacavir therapy (see Section 4.8 Description of selected adverse reactions).
Croatian: U rijetkim su slučajevima po život opasne reakcije zabilježene unutar svega nekoliko sati nakon ponovnog uvođenja abakavira u bolesnika koji su liječenje abakavirom prekinuli zbog drugih razloga, a ne zbog simptoma reakcija preosjetljivosti (vidjeti dio 4.8, Opis odabranih nuspojava).
English: General disorders and administration site conditions: Very common:
Croatian: Opći poremećaji i reakcije na mjestu primjene: vrlo često:
English: • stomach (abdominal) pain
Croatian: • nelagoda u trbuhu (abdomenu)
English: IMPORTANT - Hypersensitivity reactions
Croatian: Upozorenja i mjere opreza VAŽNO - Reakcije preosjetljivosti
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.
Croatian: Neke od njih bile su opasne po život, a u rijetkim su slučajevima imale i smrtni ishod ako nisu bile adekvatno zbrinute.
English: Do not take supplements or multivitamins containing calcium, iron or magnesium during the 6 hours before you take Triumeq, or for at least 2 hours after you take it.
Croatian: Ne smijete uzeti nadomjeske ili multivitaminske pripravke koji sadrže kalcij, željezo ili magnezij unutar 6 sati prije primjene lijeka Triumeq niti još najmanje 2 sata nakon njegove primjene.
English: Lamivudine is predominately cleared by renal excretion of unchanged lamivudine.
Croatian: Lamivudin se najvećim dijelom uklanja izlučivanjem putem bubrega u nepromijenjenu obliku.
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Croatian: pokazuju uvelike smanjenu osjetljivost na lamivudin i smanjenu sposobnost virusne replikacije in vitro.
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓ 72% (induction of UGT1A1 and CYP3A enzymes)
Croatian: Antimikobakterijski lijekovi rifampicin/dolutegravir dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓ 72% (indukcija enzima UGT1A1 i CYP3A)
English: Co-administration of Triumeq and other medicinal products that inhibit UGT1A1, UGT1A3, UGT1A9, CYP3A4, and/or P-gp may therefore increase dolutegravir plasma concentration.
Croatian: UGT1A9, CYP3A4 i/ili P-gp stoga može povećati koncentracije dolutegravira u plazmi.
English: Population pharmacokinetic analysis of dolutegravir using data in HIV-1 infected adults showed that there was no clinically relevant effect of age on dolutegravir exposure.
Croatian: Populacijska farmakokinetička analiza dolutegravira na temelju podataka prikupljenih u odraslih osoba s HIV-1 infekcijom pokazala je da dob nije imala klinički značajan učinak na izloženost dolutegraviru.
English: Supplements or multivitamins containing calcium, iron or magnesium should be taken well separated in time from the administration of Triumeq (minimum 2 hours after or 6 hours before).
Croatian: Nadomjeske ili multivitaminske pripravke koji sadrže kalcij, željezo ili magnezij treba uzimati s većim vremenskim odmakom u odnosu na primjenu lijeka Triumeq (najmanje 2 sata nakon ili 6 sati prije).
English: • breakdown of muscle tissue
Croatian: • upala gušterače (pankreatitis) • razgradnja mišićnog tkiva
English: Do not take supplements or multivitamins containing calcium, iron or magnesium during the 6 hours before you take Triumeq, or for at least 2 hours after you take it (see also Section 3).
Croatian: Ne smijete uzeti nadomjeske ili multivitaminske pripravke koji sadrže kalcij, željezo ili magnezij unutar 6 sati prije primjene lijeka Triumeq niti još najmanje 2 sata nakon njegove primjene (pogledajte i dio 3.)
English: Abacavir has a weak potential to cause chromosomal damage both in vitro and in vivo at high tested concentrations.
Croatian: Ispitivanja su pokazala da visoke koncentracije abakavira imaju slab potencijal da izazovu kromosomska oštećenja in vitro i in vivo.
English: Antiviral activity in combination with other antiviral agents No antagonistic effects in vitro were seen with dolutegravir and other antiretrovirals (tested agents: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc, adefovir and raltegravir).
Croatian: Nisu primijećeni antagonistički učinci in vitro kod primjene dolutegravira i drugih antivirotika (ispitivani lijekovi: stavudin, abakavir, efavirenz, nevirapin, lopinavir, amprenavir, enfuvirtid,
English: Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions)
Croatian: nadomjesci kalcija/dolutegravir dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (stvaranje kompleksa s polivalentnim ionima)
English: 13.4 g)/Lamivudine oral solution 300 mg Lamivudine:
Croatian: Jednokratna doza oralne otopine lamivudina od 300 mg lamivudin:
English: Nevirapine/Dolutegravir
Croatian: lamivudin i dolutegravir.
English: Moderate amount of data (more than 600 outcomes from first trimester) indicates no malformative toxicity for abacavir.
Croatian: Umjerena količina podataka o primjeni abakavira (više od 600 ishoda nakon izloženosti u prvom tromjesečju trudnoće) ne ukazuje na malformacijsku toksičnost.
English: • indigestion
Croatian: • omamljenost
English: Similar levels of virologic suppression were maintained in both the Early and Late Switch groups at 48 weeks.
Croatian: Virusna supresija u 48. tjednu održala se na sličnoj razini i u skupini koja je rano prešla na fiksnu kombinaciju i u onoj koja prešla kasnije.
English: HIV-1 RNA <50 copies/mL for those on ABC/3TC * Adjusted for baseline stratification factors.
Croatian: HIV-1 RNK <50 kopija/ml u bolesnika koji primaju ABC/3TC Medijan vremena do virusne supresije**
English: • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than
Croatian: • rasprostranjen osip praćen mjehurićima i ljuštenjem kože, osobito oko usta, nosa, očiju i genitalija
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.
Croatian: HIV-1 infekcijom koje prethodno nisu primale antiretrovirusnu terapiju bilo je randomizirano u omjeru 1:1 za primanje fiksne kombinacije DTG/ABC/3TC u dozi od 50 mg/600 mg/300 mg ili za primanje atazanavira u dozi od 300 mg plus ritonavira u dozi od 100 mg plus fiksne kombinacije tenofovirdizoproksila/emtricitabina u dozi od 245 mg/200 mg (ATV+RTV+ fiksna kombinacija TDF/FTC); svi ti lijekovi primjenjivali su se jedanput na dan.
English: Demographics Median Age (years) Female Non-white Hepatitis B and/ or C CDC class C Week 48 Efficacy Results HIV-1 RNA <50 copies/mL Treatment difference
Croatian: Demografske značajke medijan dobi (godine) žene ispitanici koji nisu bijelci hepatitis B i/ili C kategorija C prema CDC klasifikaciji osnovno liječenje kombinacijom ABC/3TC
English: Dolutegravir, abacavir and lamivudine have been shown to inhibit replication of lab-strains and clinical isolates of HIV in a number of cell types, including transformed T cell lines, monocyte/macrophage derived lines and primary cultures of activated peripheral blood mononuclear cells (PMBCs) and monocyte/macrophages.
Croatian: T-limfocita, stanične linije nastale od monocita/makrofaga te primarne kulture aktiviranih mononuklearnih stanica periferne krvi i monocita/makrofaga.
English: Table 4: Demographics and virologic outcomes of randomized treatment of SPRING-2 (snapshot algorithm)
Croatian: Tablica 4: Demografske značajke i virološki ishodi randomiziranog liječenja u ispitivanju SPRING-2
English: Following a single dose of 600 mg of abacavir, the mean (CV) Cmax is 4.26 µg/ml (28%) and the mean (CV)
Croatian: Nakon jednokratne doze abakavira od 600 mg, srednja vrijednost (CV) Cmax iznosi 4,26 µg/ml (28%), a srednja vrijednost (CV) AUC∞ 11,95 µg.h/ml (21%).
English: NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg film-coated tablets
Croatian: Triumeq 50 mg/600 mg/300 mg filmom obložene tablete
English: Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years.
Croatian: Nakon dvogodišnje primjene abakavira primijećena je blaga degeneracija miokarda u srcima miševa i štakora.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/940/002
Croatian: EU/1/14/940/001 EU/1/14/940/002
English: Iron supplements/Dolutegravir Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
Croatian: nadomjesci željeza/dolutegravir dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (stvaranje kompleksa s polivalentnim ionima)
English: dizziness, somnolence, lethargy1
Croatian: omaglica, somnolencija, letargija1
English: Non-white
Croatian: Rasa bijelci
English: DTG/ABC/3TC FDC N=248
Croatian: Fiksna kombinacija DTG/ABC/3TC N=248
English: The risk for abacavir HSR to occur is high for patients who test positive for the HLA-B*5701 allele.
Croatian: Rizik od pojave reakcija preosjetljivosti na abakavir je visok u bolesnika s pozitivnim nalazom na alel HLA-B*5701.
English: Other common symptoms are: nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness.
Croatian: Drugi česti simptomi su: mučnina, povraćanje, proljev, bol u trbuhu, izrazit umor.
English: Triumeq includes lamivudine, which is active against hepatitis B. Abacavir and dolutegravir lack such activity.
Croatian: Triumeq sadrži lamivudin, koji djeluje protiv hepatitisa B.
English: Dolutegravir is highly bound (> 99%) to human plasma proteins based on in vitro data.
Croatian: Podaci in vitro pokazuju da se dolutegravir u visokom stupnju (> 99%) veže za proteine u plazmi ljudi.
English: The IC50 for dolutegravir in various lab-strains using PBMC was 0.5 nM, and when using MT-4 cells it ranged from 0.7-2 nM.
Croatian: IC50 za dolutegravir u različitim laboratorijskim sojevima na mononuklearnim stanicama periferne krvi iznosio je 0,5 nM, a na MT-4 stanicama kretao se u rasponu od 0,7-2 nM. Slične vrijednosti IC50
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.
Croatian: Kada se razmatra bolesnikova sposobnost upravljanja vozilima ili rada sa strojevima, na umu treba imati kliničko stanje bolesnika i profil nuspojava lijeka Triumeq.
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with etravirine (without boosted protease inhibitors), efavirenz, nevirapine, rifampicin, tipranavir/ritonavir, carbamazepine, phenytoin, phenobarbital and St. John's wort, the use of Triumeq is not recommended for patients taking these medicines (see section 4.5).
Croatian: Budući da pri istodobnoj primjeni s etravirinom (bez pojačanih inhibitora proteaze), efavirenzom, nevirapinom, rifampicinom, tipranavirom/ritonavirom, karbamazepinom, fenitoinom, fenobarbitalom i gospinom travom, preporučena doza dolutegravira iznosi 50 mg dvaput na dan, primjena lijeka
English: Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Croatian: Abakavir se ne smije primjenjivati u bolesnika za koje se zna da su nositelji alela HLA-B*5701.
English: Reproductive toxicology
Croatian: Antiretrovirusni lijekovi
English: These may affect up to 1 in 1000 people:
Croatian: Rijetke nuspojave Mogu se javiti u do 1 na 1000 osoba:
English: AUC ↓ 32%
Croatian: abakavir AUC ↓ 32%
English: Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of race on the exposure of dolutegravir.
Croatian: Populacijska farmakokinetička analiza objedinjenih farmakokinetičkih podataka iz ispitivanja faze IIb i faze III u odraslih bolesnika nije ukazala na klinički značajan učinak rase na izloženost dolutegraviru.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Croatian: međutim, prijavljeno vrijeme do njihova nastupa je različito pa se ti događaji mogu javiti i mjesecima nakon uvođenja liječenja (vidjeti dio 4.4).
English: • lactic acidosis (excess lactic acid in the blood).
Croatian: površine tijela (toksična epidermalna nekroliza) • laktacidoza (nakupljanje mliječne kiseline u krvi).
English: Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Croatian: Ispitivanja u bolesnika s oštećenjem bubrežne funkcije pokazuju da poremećaj funkcije bubrega utječe na eliminaciju lamivudina.
English: Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of gender on the exposure of dolutegravir.
Croatian: Populacijska farmakokinetička analiza objedinjenih farmakokinetičkih podataka iz ispitivanja faze IIb i faze III u odraslih bolesnika nije ukazala na klinički značajan učinak spola na izloženost dolutegraviru.
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.
Croatian: abakavira od 0,08 µg/ml ili 0,26 µM nakon primjene doze abakavira od 600 mg dvaput na dan.
English: While the total dolutegravir concentration in plasma was similar, a 1.5 to 2-fold increase in unbound exposure to dolutegravir was observed in subjects with moderate hepatic impairment compared to healthy controls.
Croatian: Iako je ukupna koncentracija dolutegravira u plazmi bila podjednaka, u ispitanika s umjerenim oštećenjem jetre izloženost nevezanom dolutegraviru bila
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.
Croatian: koji su prethodno liječeni antiretroviroticima, pokazala je da primjena dolutegravira u dozi od 50 mg jedanput na dan dovodi do izloženosti dolutegraviru usporedive s onom primijećenom u odraslih bolesnika koji su primali dolutegravir u dozi od 50 mg jedanput na dan.
English: Abacavir is primarily metabolised by the liver.
Croatian: Abakavir se prvenstveno metabolizira u jetri.
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don't stop Triumeq without your doctor's advice, as your hepatitis may come back)
Croatian: • ako imate umjerenu ili tešku bolest jetre • ako ste nekada imali bolest jetre, uključujući hepatitis B ili C (ako imate infekciju hepatitisom B,
English: Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy.
Croatian: U nekih bolesnika s istodobnom infekcijom hepatitisom B i/ili C, u skladu sa sindromom imunološke rekonstitucije, primijećena su povišenja biokemijskih pokazatelja jetrene funkcije na početku liječenja dolutegravirom.
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.
Croatian: Budući da preporučena doza dolutegravira pri istodobnoj primjeni s tipranavirom/ritonavirom iznosi 50 mg dvaput na dan, ne preporučuje se istodobna primjena tipranavira/ritonavira i lijeka Triumeq.
English: Hypersensitivity reactions (see section 4.8)
Croatian: sindrom imunološke rekonstitucije (vidjeti dio 4.4)
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.
Croatian: Nakon prekida liječenja lijekom Triumeq zbog suspektne reakcije preosjetljivosti, nikada se ne smije ponovno započeti liječenje lijekom Triumeq niti bilo kojim drugim lijekom koji sadrži abakavir ili dolutegravir.
English: Early Switch ABC/DTG/3TC FDC N=275 n (%)
Croatian: Rani prelazak na fiksnu kombinaciju ABC/DTG/3TC N=275 n (%)
English: In 100% human serum, the mean fold shift for dolutegravir activity was 75-fold, resulting in protein adjusted IC90 of 0.064 ug/mL.
Croatian: puta, što je za posljedicu imalo vrijednost IC90 prilagođenu za proteine od 0,064 μg/ml.
English: • numbness, tingly feelings in the skin (pins and needles)
Croatian: • utrnulost, trnci na koži (mravinjanje)
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.
Croatian: S obzirom da je preporučena doza dolutegravira 50 mg dvaput na dan kad se istodobno primjenjuje s karbamazepinom, fiksna kombinacija dolutegravir/abakavir/lamivudin se ne preporučuje u bolesnika koji uzimaju karbamazepin.
English: - Triumeq should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavircontaining regimen.
Croatian: statusom, niti u bolesnika s negativnim HLA-B*5701 statusom za koje se sumnja da su imali reakciju preosjetljivosti na abakavir tijekom prethodnog liječenja režimom koji je sadržavao abakavir.
English: The apparent volume of distribution of dolutegravir (following oral administration of suspension formulation, Vd/F) is estimated at 12.5 L. Intravenous studies with abacavir and lamivudine showed that the mean apparent volume of distribution is 0.8 and 1.3 l/kg respectively.
Croatian: U ispitivanjima intravenske primjene abakavira i lamivudina utvrđeno je da srednja vrijednost prividnog volumena distribucije iznosi 0,8 l/kg odnosno 1,3 l/kg.
English: Virologically suppressed (HIV-1 RNA <50 c/mL) subjects were randomly assigned (1:1) to continue their current ART regimen (2 NRTIs plus either a PI, NNRTI, or INI), or switch to ABC/DTG/3TC FDC once daily (Early Switch).
Croatian: Ispitanici s virusnom supresijom (HIV-1 RNK < 50 kopija/ml) bili su randomizirani (1:1) za nastavak dotadašnje antiretrovirusne terapije (2 NRTI-ja plus IP, NNRTI ili inhibitor integraze [INI]) ili za prelazak na fiksnu kombinaciju
English: Renal impairment Triumeq is not recommended for use in patients with a creatinine clearance < 50 ml/min (see section
Croatian: Ne preporučuje se primjena lijeka Triumeq u bolesnika s klirensom kreatinina < 50 ml/min (vidjeti dio 5.2).
English: Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔ (historical controls)
Croatian: Ostali antivirotici boceprevir dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% boceprevir ↔ (kontrole iz prethodnih ispitivanja)
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).
Croatian: 50 mg dvaput na dan, ne preporučuje se istodobna primjena efavirenza i lijeka Triumeq (vidjeti dio 4.4).
English: Package leaflet: Information for the patient Triumeq 50 mg/600 mg/300 mg film-coated tablets dolutegravir/abacavir/lamivudine
Croatian: Uputa o lijeku: Informacije za bolesnika Triumeq 50 mg/600 mg/300 mg filmom obložene tablete dolutegravir/abakavir/lamivudin
English: Baseline CD4+ (cells/ mm3)
Croatian: (stanice/mm3)
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).
Croatian: ili E92Q, nije primijećena daljnja selekcija rezistencije (vrijednost promjene od približno 1 ostala je nepromijenjena).
English: Co-administration with nevirapine may decrease dolutegravir plasma concentration due to enzyme induction and has not been studied.
Croatian: Istodobna primjena s nevirapinom nije ispitivana, ali bi zbog indukcije enzima mogla smanjiti koncentraciju dolutegravira u plazmi.
English: For patients co-infected with hepatitis B who are being treated with a lamivudine containing medicinal product such as Triumeq and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.
Croatian: poput lijeka Triumeq, i u međuvremenu zatrudne, mora se razmotriti mogućnost recidiva hepatitisa nakon prekida liječenja lamivudinom.
English: In HIV-1-infected adult subjects following dolutegravir 50 mg once daily, the steady-state pharmacokinetic parameters (geometric mean [%CV]) based on population pharmacokinetic analyses were AUC(0-24) = 53.6 (27) µg.h/mL, Cmax = 3.67 (20) µg/mL, and Cmin = 1.11 (46) µg/mL.
Croatian: AUC(0-24) = 53,6 (27) µg.h/ml, Cmax = 3,67 (20) µg/ml i Cmin = 1,11 (46) µg/ml.
English: You should never take abacavir or abacavircontaining products again if you have a hypersensitivity reaction: it can be life threatening.
Croatian: Ako razvijete reakciju preosjetljivosti ne smijete više nikada uzimati abakavir ili lijekove koji sadrže abakavir: to može ugroziti život.
English: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28%
Croatian: lopinavir+ritonavir+etravirin/ dolutegravir dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28%
English: Renal impairment Pharmacokinetic data have been obtained for dolutegravir, lamivudine and abacavir separately.
Croatian: Oštećenje bubrežne funkcije Prikupljeni su farmakokinetički podaci za dolutegravir, lamivudin i abakavir kao zasebne djelatne tvari.
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.
Croatian: osim negativnog nalaza mikronukleusnog testa provedenog na štakorima in vivo, kojim su se ispitivali učinci kombinacije abakavira i lamivudina.
English: Joint pain, stiffness and bone problems
Croatian: Bol u zglobovima, ukočenost i tegobe s kostima