FrancophonIA/ELRC3.0 huggingface dataset:
English: Opadry Orange YS-1-13065-A containing: hypromellose titanium dioxide macrogol 400 polysorbate 80 sunset yellow FCF (E110)
Croatian: Opadry Orange YS-1-13065-A koja sadrži: hipromelozu titanijev dioksid makrogol 400 polisorbat 80 “sunset yellow FCF ” (E110) 6.2 Inkompatibilnosti
English: In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting.
Croatian: In vitro lamivudin inhibira unutarstaničnu fosforilaciju kladribina što dovodi do potencijalne opasnosti gubitka djelotvornosti kladribina u slučaju kombinacije u kliničkom okruženju..Neki klinički nalazi također ukazuju na moguću interakciju između lamivudina i kladribina.
English: However, abacavir HSRs have been reported at a lower frequency in patients who do not carry this allele.
Croatian: Međutim, reakcije preosjetljivosti na abakavir prijavljene su s nižom učestalošću i u bolesnika koji nisu nositelji tog alela.
English: Additional risk minimisation activity
Croatian: Dodatne mjere minimalizacije rizika
English: If Kivexa is discontinued in patients co-infected with HBV, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis (see the Summary of Product Characteristics for products containing lamivudine that are indicated for the treatment of HBV).
Croatian: Ako se ukida liječenje lijekom Kivexa u bolesnika istodobno zaraženih HBV-om, preporučuje se periodičko praćenje testova funkcije jetre i markera HBV replikacije budući da prestanak uzimanja lamivudina može izazvati egzacerbaciju hepatitisa (vidjeti Sažetak opisa svojstava lijeka za lijekove koji sadrže lamivudin i indicirani su za liječenje HBV-a).
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.
Croatian: HIV-1 izolati (CRF01_AE, n=12; CRF02_AG, n=12; i podtip C ili CRF_AC, n=13) od 37 neliječenih bolesnika iz Afrike i Azije bili su osjetljivi na abakavir (IC50 promjena <2,5 puta), i lamivudin (IC50
English: Abacavir is associated with a risk for hypersensitivity reactions (HSR) (see section4.8) ) characterised by fever and/or rash with other symptoms indicating multi-organ involvement.
Croatian: Reakcije preosjetljivosti (vidjeti također dio 4.8) Abakavir se povezuje s rizikom od reakcija preosjetljivosti (vidjeti dio 4.8), koje karakteriziraju vrućica i/ili osip praćeni drugim simptomima koji upućuju na zahvaćenost većeg broja organa.
English: In pregnant women treated with abacavir, more than 800 outcomes after first trimester exposure and more than 1000 outcomes after second and third trimester exposure indicate no malformative and foetal/neonatal effect.
Croatian: U trudnica liječenih abakavirom, više od 800 ishoda trudnoća nakon izlaganja lijeku u prvom tromjesečju te više od 1000 ishoda nakon izlaganja lijeku u drugom i trećem tromjesečju trudnoće ukazuju da abakavir ne uzrokuje malformacije i da nema feto/neonatalni učinak.
English: The median or mean EC50 values for lamivudine against laboratory strains of HIV-1 ranged from 0.007 to 2.3 µM.
Croatian: Medijan ili srednje vrijednosti EC50 za lamivudin protiv laboratorijskih sojeva HIV-1 kretale su se u rasponu od 0,007 do 2,3 µM.
English: Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg (see sections 4.4 and 5.1).
Croatian: Kivexa je indicirana za liječenje infekcije virusom humane imunodeficijencije (HIV) u odraslih, adolescenata i djece tjelesne težine od najmanje 25 kg kao dio kombinacijske antiretrovirusne terapije (vidjeti dijelove 4.4 i 5.1).
English: The Kivexa pack includes an Alert Card, to remind you and medical staff about abacavir hypersensitivity.
Croatian: Pakiranje lijeka Kivexa sadrži i Karticu s upozorenjem, kako bi podsjetila Vas i medicinsko osoblje na moguću preosjetljivost na abakavir.
English: This recurrence of the HSR is usually more severe than on initial presentation, and may include lifethreatening hypotension and death.
Croatian: Ta ponovna reakcija preosjetljivosti obično je još teža nego prvotna, a može uključivati po život opasnu hipotenziju i smrt.
English: In reproductive toxicity studies in animals, lamivudine and abacavir were shown to cross the placenta.
Croatian: U ispitivanjima reproduktivne toksičnosti na životinjama pokazalo se da lamivudin i abakavir prolaze placentarnu barijeru.
English: Some people who take abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which can be life-threatening if they continue to take abacavir containing products.
Croatian: Neki bolesnici koji uzimaju abakavir mogu razviti reakciju preosjetljivosti (ozbiljnu alergijsku reakciju) koja može biti opasna po život ako se nastavi s uzimanjem lijekova koji sadrže abakavir.
English: These may affect up to 1 in 10,000 people:
Croatian: Mogu se pojaviti u manje od 1 na 10 000 osoba:
English: Phenotypic cross-resistance to other NRTIs with M184V or M184I mutation alone is limited.
Croatian: Fenotipska križna rezistencija s drugim NRTI u prisustvu samo M184V ili samo M184I je ograničena.
English: TAMs might be selected when thymidine analogs are associated with abacavir.
Croatian: Do selekcije mutacije analoga timidina (TAMs) može doći kad su analozi timidina povezani s abakavirom.
English: HIV-1 resistance to lamivudine involves the development of a M184I or, more commonly, M184V amino acid change close to the active site of the viral RT.
Croatian: Rezistencija HIV-1 na lamivudin uključuje promjenu aminokiseline M184I ili češće M184V u blizini aktivnog mjesta virusne RT.
English: How to take Kivexa
Croatian: Kako uzimati lijek Kivexa
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Croatian: Zabilježeni su slučajevi osteonekroze, osobito u bolesnika s opće priznatim faktorima rizika,
English: ACTG 5202 study was a, multi-centre, comparative, randomised study of double-blind abacavir/lamivudine or emtricitabine/tenofovir in combination with open-label efavirenz or atazanavir/ritonavir in treatment-naïve HIV-1 infected patients.
Croatian: ACTG 5202 ispitivanje je multicentrično, komparativno, randomizirano dvostruko slijepo ispitivanje abakavir/lamivudin ili emtricitabin/tenofovir u kombinaciji s otvorenom studijom efavirenza ili atazanavir/ritonavira u liječenju prethodno neliječenih HIV-1 zaraženih bolesnika.
English: In the fasted state there was no significant difference in the extent of absorption, as measured by the area under the plasma concentration-time curve (AUC) and maximal peak concentration (Cmax), of each component.
Croatian: Na temelju površine pod krivuljom koncentracije u plazmi u ovisnosti o vremenu (AUC) i maksimalne koncentracije (Cmax)
English: Those studied were mainly antiretroviral experienced patients.
Croatian: Te su studije najvećim dijelom promatrale bolesnike koji su do tada primali antiretrovirusnu terapiju.
English: Pharmacokinetic data has been obtained for abacavir and lamivudine separately.
Croatian: Farmakokinetički podaci su dobiveni odvojeno za abakavir i lamivudin.
English: The mean EC50 for abacavir against laboratory strains of HIV-1IIIB and HIV-1HXB2 ranged from 1.4 to 5.8 µM.
Croatian: Srednja vrijednost EC50 za abakavir protiv laboratorijskih sojeva HIV-1IIIB i HIV-1HXB2 kretala se u rasponu od 1,4 do 5,8 µM.
English: In a study of 20 HIV-infected patients receiving abacavir 300 mg twice daily, with only one 300 mg dose taken prior to the 24 hour sampling period, 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 in this study of 2.6 hours.
Croatian: U ispitivanju 20 bolesnika zaraženih virusom HIV-a, koji su primali abakavir u dozi od 300 mg dvaput na dan pri čemu su jednu dozu od 300 mg uzeli prije 24-satnog razdoblja uzimanja uzoraka, geometrijska sredina terminalnog unutarstaničnog poluvijeka karbovir-TP-a u stanju dinamičke ravnoteže iznosila je 20,6 sati u usporedbi s geometrijskom sredinom poluvijeka abakavira u plazmi od 2,6 sati.
English: Overall the available data from observational cohorts and from randomised trials show some inconsistency so can neither confirm nor refute a causal relationship between abacavir treatment and the risk of myocardial infarction.
Croatian: Sveukupni dostupni podaci iz opservacijskih kohorti i randomiziranih ispitivanja ukazali su na određenu nedosljednost zbog čega se ne može do kraja isključiti ili povezati razvoj infarkta miokarda s uporabom abakavira.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/298/003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/298/003
English: • cladribine, used to treat hairy cell leukaemia
Croatian: • kladribin, za liječenje leukemije srpastih stanica
English: Logistic regression modelling of the predictive value for genotype (adjusted for baseline plasma HIV-1RNA [vRNA], CD4+ cell count, number and duration of prior antiretroviral therapies) showed that the presence of 3 or more NRTI resistance-associated mutations was associated with reduced response at Week 4 (p=0.015) or 4 or more mutations at median Week 24 (p≤0.012).
Croatian: broj CD4+ stanica, broj i trajanje prethodnih antiretrovirusnih terapija) pokazao je da je prisustvo 3 ili više mutacija povezanih s rezistencijom na NRTI povezano sa smanjenim odgovorom u 4. tjednu liječenja (p=0.015), a prisustvo 4 ili više mutacija prosječno u 24. tjednu (p≤0.012).
English: The combination of abacavir and lamivudine as a once daily regimen is supported by a 48 weeks multi-centre, double-blind, controlled study (CNA30021) of 770 HIV-infected, therapy-naïve adults.
Croatian: Režim doziranja kombinacije abakavir/lamivudin jedanput na dan podupire multicentrično, dvostruko slijepo, kontrolirano ispitivanje (CNA30021) u trajanju od 48 tjedana, provedeno na 770 prethodno neliječenih odraslih bolesnika zaraženih virusom HIV-a.
English: Symptoms usually appeared within the first six weeks (median time to onset 11 days) of initiation of treatment with abacavir, although these reactions may occur at any time during therapy.
Croatian: (medijan vremena do nastupa iznosio je 11 dana) nakon početka liječenja abakavirom, iako se te reakcije mogu pojaviti u bilo kojem trenutku tijekom liječenja.
English: 30% of the body surface (toxic epidermal necrolysis).
Croatian: 30% površine tijela (toksična epidermalna nekroliza) • laktacidoza (nakupljanje mliječne kiseline u krvi)
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Croatian: U slučaju da bolesnik istodobno prima neki antivirusni lijek za liječenje hepatitisa B ili C, treba proučiti Sažetke opisa svojstava lijeka i za te lijekove.
English: Within this population, 104 HIV-1 infected paediatric subjects weighing at least 25 kg received abacavir and lamivudine as
Croatian: Unutar te populacije 104 pedijatrijskih ispitanika zaraženih s HIV-1, tjelesne težine od najmanje 25 kg, primalo je abakavir i lamivudin kao lijek Kivexa jedanput na dan.
English: Safety Concern
Croatian: Data Safety
English: Therefore, the concomitant use of lamivudine with cladribine is not recommended (see section 4.4).
Croatian: Stoga se ne preporučuje istodobna primjena kladribina i lamivudina (vidjeti dio 4.4).
English: Baseline HIV-1 samples from therapy-naive subjects with no amino acid substitutions associated with resistance have been evaluated using either the multi-cycle Virco Antivirogram™ assay (n=92 from COL40263) or the the single cycle Monogram Biosciences PhenoSense™ assay (n=138 from ESS30009).
Croatian: Procjena početnih uzoraka HIV-1 neliječenih bolesnika koji nisu povezani sa supstitucijom aminokiselina povezane s rezistencijom vršila se ili više ciklusnim Virco Antivirogram testom (eng. multi-cycle Virco Antivirogram™ assay) (n=92 u ispitivanju COL40263) ili testom sa jednim ciklusom (Monogram Biosciences PhenoSense™ assay) (n=138 u ispitivanju ESS30009).
English: Symptoms related to this HSR worsen with continued therapy and can be life- threatening and in rare instance, have been fatal.
Croatian: Simptomi povezani s tom reakcijom preosjetljivosti pogoršavaju se s nastavkom liječenja i mogu ugroziti život, a u rijetkim su slučajevima imali smrtni ishod.
English: • Restarting abacavir containing products following a suspected abacavir HSR can result in a prompt return of symptoms within hours.
Croatian: • Ponovno uvođenje lijekova koji sadrže abakavir nakon suspektne reakcije preosjetljivosti na abakavir može dovesti do brzog povratka simptoma unutar svega nekoliko sati.
English: EPZ104057 (HEAT study) was a randomised, double-blind, placebo-matched, 96 week, multi-centre study with the primary objective of evaluating the relative efficacy of abacavir/lamivudine (ABC/3TC, 600mg/300mg) and tenofovir /emtricitabine (TDF/FTC, 300mg/200mg), each given once-daily in combination with lopinavir/ritonavir (LPV/r, 800mg/200mg) in HIV-infected, therapy-naive adults.
Croatian: EPZ104057 (HEAT ispitivanje) je randomizirana, dvostruko slijepa, placebo povezana, 96-tjedna, multicentrično ispitivanje s primarnim ciljem procjene relativne djelotvornosti abakavira/lamivudina (ABC/3TC, 600mg/300mg) i tenofovira/emtricitabina (TDF/FTC, 300mg/200mg), pojedini davan jednom dnevno u kombinaciji s lopinavirom/ritonavirom (LPV/r, 800mg/200mg) kod HIV inficiranih, prethodno neliječenih odraslih bolesnika.
English: Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4).
Croatian: Prije započinjanja liječenja abakavirom, za svakog bolesnika zaraženog virusom HIV-a, bez obzira na rasno podrijetlo, mora se odrediti je li nositelj alela HLA-B*5701 (vidjeti dio 4.4).
English: Common: rash (without systemic symptoms) Very rare: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Croatian: Vrlo rijetko: multiformni eritem, Stevens-Johnsonov sindrom i toksična epidermalna nekroliza
English: • hypersensitivity reaction
Croatian: • reakcija preosjetljivosti
English: The special warnings and precautions relevant to abacavir and lamivudine are included in this section.
Croatian: U ovom poglavlju navedena su posebna upozorenja i mjere opreza koje se odnose na abakavir i lamivudin.
English: Before initiating abacavir therapy, clinicians should screen for HLA-B*5701 .
Croatian: Prije započinjanja liječenja abakavirom, kliničari moraju izvršiti probir na HLA-B*5701.
English: Proportion with HIV-1 RNA <50 copies/ml
Croatian: Udio sa HIV-1 RNA <50 kopija/ml
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: negativne dojenčadi izložene in utero i/ili postnatalno nukleozidnim analozima (vidjeti dio 4.4).
English: Therapy should be prescribed by a physician experienced in the management of HIV infection.
Croatian: 4.2 Doziranje i način primjene Terapiju mora propisati liječnik s iskustvom u liječenju HIV infekcije.
English: Restarting abacavir following an abacavir HSR results in a prompt return of symptoms within hours.
Croatian: Ponovno uvođenje abakavira nakon reakcije preosjetljivosti na abakavir dovodi do brzog povratka simptoma unutar nekoliko sati.
English: 1206 paediatric patients aged 3 months to 17 years enrolled in the ARROW Trial (COL105677) and were dosed according to the weight - band dosing recommendations in the World Health Organisation treatment guidelines (Antiretroviral therapy of HIV infection in infants and children, 2006).
Croatian: 1206 pedijatrijskih bolesnika u dobi od 3 mjeseca do 17 godina, kojima su se lijekovi dozirali sukladno preporukama za doziranje prema tjelesnoj težini, objavljenima u smjernicama za liječenje Svjetske zdravstvene organizacije (Antiretrovirusna terapija za dojenčad i djecu zaraženu HIV-om,
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Croatian: • kožni osip, koji može stvarati mjehuriće na koži i izgledati kao male mete (tamne točke u središtu,
English: Results at 48 weeks indicated that the Kivexa group was associated with a similar virologic outcome (non-inferior) compared to the abacavir plus lamivudine group, based on proportions of subjects with HIV-1 RNA < 50 copies/ml (90% and 85% respectively, 95% CI -2.7, 13.5).
Croatian: Rezultati u 48. tjednu pokazuju da je u skupini koja je primala lijek Kivexa virološki odgovor bio podjednak (neinferioran) odgovoru u skupini koja je primala abakavir i lamivudin, na temelju postotka osoba s HIV-1 RNK < 50 kopija/ml (90%, odnosno 85%, 95% CI; -2,7; 13,5).
English: Tablet Core magnesium stearate microcrystalline cellulose sodium starch glycollate
Croatian: Jezgra tablete: magnezijev stearat celuloza, mikrokristalična natrijev škroboglikolat.
English: Similar proportions of patients in the once-daily and twice-daily abacavir arms of CAL30001 had GSS scores of <2 or ≥2 and successfully suppressed to <50 copies/mL by Week 48.
Croatian: Slični udjeli bolesnika u skupinama koje su primale abakavir jednom ili dva puta dnevno u ispitivanju CAL30001 imali su GSS indekse <2 ili >2 te su uspješno do 48. tjedna postigli supresiju na <50 kopija/mL.
English: For lamivudine, the EC50 values against HIV-1 subtypes (A-G) ranged from 0.001 to 0.170 µM, against Group O from 0.030 to 0.160 µM and against HIV-2 isolates from 0.002 to 0.120 µM in peripheral blood mononuclear cells.
Croatian: Za lamivudin, vrijednosti EC50 protiv HIV-1 podtipovima (A-G) kretale su se od 0,001 do 0,170 µM, protiv grupe O od 0,030 do 0,160 µM i protiv HIV-2 izolata od 0,002 do 0,120 µM u perifernoj krvi mononuklearnih stanica.
English: In a meta-analysis of six clinical trials, TAMs were not selected by regimens containing abacavir without zidovudine (0/127), but were selected by regimens containing abacavir and the thymidine analogue zidovudine
Croatian: U meta analizi 6 kliničkih ispitivanja, selekcije mutacija analoga timidina nisu utvrđene u režimima liječenja koji su uključivali abakavir bez zidovudina (0/127), ali jesu u režimima liječenja koji su uključivali abakavir i analog timidina zidovudin (22/86, 26%).
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.
Croatian: Maligni tumori javljali su se na prepucijskoj žlijezdi u mužjaka i klitoralnoj žlijezdi u ženki obje vrste, te u štakora na štitnoj žlijezdi u mužjaka te u jetri, mokraćnom mjehuru, limfnim čvorovima i potkožnom tkivu u ženki.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Croatian: Bolesnici s istodobnom kroničnom infekcijom virusom hepatitisa B ili C Bolesnici s kroničnim hepatitisom B ili C koji su na kombiniranoj antiretrovirusnoj terapiji imaju povećani rizik od nastupa teških i potencijalno fatalnih nuspojava jetre.
English: Rare: Rhabdomyolysis
Croatian: Rijetko: rabdomioliza
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer label of 90 (3 packs of 30 film-coated tablets) (with Blue Box) wrapped in clear plastic foil
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska naljepnica za 90 (3 pakiranja od 30 tableta) (sa Plavim okvirom) omotanih u prozirnu plastičnu foliju
English: Anyone taking Kivexa could develop a hypersensitivity reaction to abacavir, which could be life threatening if they continue to take Kivexa.
Croatian: Svatko tko uzima lijek Kivexa može razviti reakciju preosjetljivosti na abakavir koja može ugroziti život bolesnika, ako nastavi uzimati lijek Kivexa.
English: Phenotypic resistance to abacavir requires M184V with at least one other abacavir-selected mutation, or M184V with multiple TAMs.
Croatian: Za fenotipsku rezistenciju na abakavir potrebna je mutacija M184V uz najmanje još jednu abakavirom uzrokovanu mutaciju ili mutacija M184V s višestrukim mutacijama analoga timidina.
English: Overall response (stratified by baseline HIV-1 RNA) Response by Baseline HIV-1 RNA <100,000 c/ml Response by Baseline HIV-1 RNA ≥100,000 c/ml
Croatian: Ukupan odgovor (odijeljen na osnovu HIV-1 RNK) Odgovor na osnovu HIV-1 RNA <100 000 c/ml Odgovor na osnovu HIV-1 RNA ≥100 000 c/ml
English: LIST OF EXCIPIENTS Contains sunset yellow (E110), see leaflet for further information
Croatian: Sadrži sunset yellow (E110), za ostale informacije vidjeti uputu
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Croatian: U bolesnika zaraženih virusom HIV-a, koji u trenutku započinjanja kombiniranog antiretrovirusnog liječenja imaju teški imunološki deficit, može se razviti upalna reakcija na asimptomatske ili rezidualne oportunističke patogene te izazvati ozbiljna klinička stanja ili pogoršanje simptoma.
English: Genotypic sensitivity scores were not obtained for all patients at baseline.
Croatian: Indeks genotipske osjetljivosti nije rađen za sve bolesnike na samom početku.
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: Abacavir HSR has been well characterised through clinical studies and during post marketing follow-up.
Croatian: Reakcije preosjetljivosti na abakavir temeljito su okarakterizirane tijekom kliničkih ispitivanja i praćenja nakon stavljanja lijeka u promet.
English: • a decrease in the number of cells involved in blood clotting (thrombocytopenia).
Croatian: • smanjenje broja trombocita, krvnih pločica važnih za zgrušavanje krvi (trombocitopenija).
English: Delay in stopping treatment with abacavir after the onset of hypersensitivity may result in an immediate and life-threatening reaction.
Croatian: Odgađanje prekida liječenja abakavirom nakon pojave preosjetljivosti može rezultirati trenutnom i po život opasnom reakcijom.
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
Croatian: • lijekovi (obično u tekućem obliku) koji sadrže sorbitol i druge šećerne alkohole (poput ksilitola,
English: The pharmacokinetic properties of lamivudine and abacavir are described below.
Croatian: Farmakokinetička svojstva lamivudina i abakavira opisana su u daljnjem tekstu.
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.
Croatian: Zbog promjena povezanih s dobi, poput smanjenja bubrežne funkcije i promjena hematoloških parametara,
English: Data from two studies, CAL30001 and ESS30008 demonstrated that Kivexa once daily has similar virological efficacy to abacavir 300 mg twice daily plus lamivudine 300 mg once daily or 150 mg twice daily in therapy-experienced patients.
Croatian: Podaci iz dva ispitivanja, CAL30001 i ESS30008 pokazali su da je Kivexa jedan put na dan, u bolesnika koji su ranije primali terapiju, slične virusne djelotvornosti poput abakavira od 300 mg dva puta na dan plus lamivudin 300 mg jedan put na dan ili 150 mg dva puta na dan.