FrancophonIA/ELRC3.0 huggingface dataset:
English: Following multiple oral doses of abacavir 300 mg twice a day there is no significant accumulation of abacavir.
Croatian: 300 mg dvaput na dan nije bilo značajnog nakupljanja abakavira.
English: Children receiving abacavir oral solution according to the recommended dosage regimen achieve plasma abacavir exposure similar to adults.
Croatian: Djeca koja primaju oralnu otopinu abakavira sukladno preporučenom režimu doziranja postižu sličnu razinu izloženosti abakaviru kao i odrasli.
English: Children weighing ≥ 20 kg to < 25 kg: The recommended dose is 450 mg daily.
Croatian: Djeca tjelesne težine od ≥ 20 kg do < 25 kg: Preporučena doza je 450 mg na dan.
English: Pains in the joints or muscles, swelling of the neck, shortness of breath, sore throat, cough, occasional headaches, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness of the hands or feet.
Croatian: Bolove u zglobovima ili mišićima, oticanje vrata, nedostatak zraka, grlobolju, kašalj, povremene glavobolje, upalu oka (konjunktivitis), vrijedovi u ustima, nizak krvni tlak, trnce ili utrnulost šaka ili stopala.
English: • if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir - such as Triumeq, Trizivir or Kivexa) or any of the other ingredients of this medicine (listed in Section 6)
Croatian: • ako ste alergični (preosjetljivi) na abakavir (ili bilo koji lijek koji sadržava abakavir npr. Triumeq, Trizivir ili Kivexa), ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Ziagen can be taken with or without food.
Croatian: Ziagen možete uzimati s ili bez hrane.
English: Methadone: in a pharmacokinetic study, co-administration of 600 mg abacavir twice daily with methadone showed a 35% reduction in abacavir Cmax and a one hour delay in tmax but the AUC was unchanged.
Croatian: U farmakokinetičkom ispitivanju istodobna primjena 600 mg abakavira dvaput na dan i metadona rezultirala je 35% smanjenjem Cmax abakavira i odgađanjem tmax za jedan sat, ali je AUC ostao nepromijenjen.
English: The study Data Safety Monitoring Board stopped the ZDV/3TC/ABC arm at this time based on the higher proportion of patients with virologic failure.
Croatian: U tom trenutku je studijski odbor za prikupljanje podataka o sigurnosti primjene prekinuo liječenje u skupini koja je uzimala ZDV/3TC/ABC zbog višeg udjela bolesnika s virološkim neuspjehom.
English: Similar clinical success (point estimate for treatment difference -1.7, 95% CI -8.4, 4.9) was observed for both regimens.
Croatian: U oba režima liječenja zabilježen je sličan klinički uspjeh (ocijenjena razlika liječenja: -1,7; 95% CI -8,4; 4,9).
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: Prijavljena je mitohondrijska disfunkcija u HIV negativne novorođenčadi izložene analozima nukleozida in utero i/ili nakon rođenja (vidjeti dio 4.4).
English: Pancreatitis has been reported, but a causal relationship to abacavir treatment is uncertain.
Croatian: Zabilježen je pankreatitis, ali nije sigurna uzročna povezanost s liječenjem abakavirom.
English: You must carefully read all the information under ‘Hypersensitivity reactions' in the panel in Section 4.
Croatian: Morate pažljivo pročitati sve informacije u okviru “Reakcije preosjetljivosti” u dijelu 4.
English: Those studied were mainly antiretroviral experienced patients.
Croatian: Te su studije najvećim dijelom promatrale bolesnike koji su primali do tada antiretrovirusnu terapiju.
English: The usual dose of Ziagen is 600 mg a day.
Croatian: Uobičajena doza lijeka Ziagen je 600 mg na dan.
English: 1206 HIV-infected paediatric patients aged 3 months to 17 years were enrolled in the ARROW Trial (COL105677), 669 of whom received abacavir and lamivudine either once or twice daily (see section 5.1).
Croatian: U ispitivanje ARROW (COL105677) bilo je uključeno 1206 HIV-om zaraženih pedijatrijskih bolesnika u dobi od 3 mjeseca do 17 godina, među kojima je njih 669 primalo abakavir i lamivudin jedanput ili dvaput na dan (vidjeti dio 5.1).
English: Children from 3 months of age weighing less than 25 kg
Croatian: Djeca od navršena 3 mjeseca tjelesne težine manje od 25 kg
English: No dosage adjustment of Ziagen is necessary in patients with renal dysfunction.
Croatian: Nije potrebno prilagođavati dozu lijeka Ziagen u bolesnika s poremećajem funkcije bubrega.
English: Since Ziagen contains abacavir some patients taking Ziagen may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if treatment with Ziagen is continued.
Croatian: Budući da Ziagen sadrži abakavir, neki bolesnici koji uzimaju Ziagen mogu razviti reakciju preosjetljivosti (ozbiljnu alergijsku reakciju) koja može biti opasna po život ako se nastavi sa uzimanjem lijeka Ziagen.
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 i 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 the small sample size for genotypic analysis, there was a trend toward a higher rate of NRTI-associated mutations in the once daily versus the twice daily abacavir regimens.
Croatian: U malom uzorku za genotipsku analizu zabilježen je trend prema većoj stopi mutacija povezanih s NRTI pri doziranju abakavira jedanput na dan u odnosu na doziranje dvaput na dan.
English: The malformative risk is unlikely in humans based on those data.
Croatian: S obzirom na te podatke, rizik od malformacija u ljudi nije vjerojatan.
English: Don't push too hard and squirt the liquid into the back of your throat, or you may choke Repeat steps 3 to 7 in the same way until you have taken your whole dose.
Croatian: Nemojte gurati prejako niti špricati otopinu u stražnju stranu grla jer bi moglo doći do gušenja.
English: Ziagen oral solution also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Croatian: Ziagen oralna otopina također sadrži metilparahidroksibenzoat i propilparahidroksibenzoat koji mogu uzrokovati alergijsku reakciju (moguće i reakcije odgođene preosjetljivosti).
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, 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, geometrijsko srednje terminalno unutarstanično poluvrijeme karbovir-TP-a u stanju dinamičke ravnoteže iznosilo je 20,6 sati, u usporedbi s geometrijskim srednjim poluvremenom abakavira u plazmi od 2,6 sati.
English: If you forget to take Ziagen
Croatian: Ako ste zaboravili uzeti Ziagen
English: In PENTA 15 study, the geometric mean plasma abacavir AUC(0-24) (95% CI) of the four subjects under 12 months of age who switch from a twice daily to a once daily regimen (see section 5.1) are 15.9 (8.86, 28.5) µg.h/ml in the once-daily dosing and 12.7 (6.52, 24.6) µg.h/ml in the twice-daily dosing.
Croatian: U ispitivanju PENTA 15, geometrijska srednja vrijednost AUC(0-24) abakavira u plazmi (95% CI) u četiri ispitanika mlađa od 12 mjeseci koja su s režima primjene dvaput na dan prešla na režim primjene jedanput na dan (vidjeti dio 5.1) iznosila je 15,9 (8,86; 28,5) µg.h/ml uz doziranje jedanput na dan te 12,7 (6,52; 24,6) µg.h/ml uz doziranje dvaput na dan.
English: Similarly, greater proportions of children treated with the abacavir containing combinations had HIV-1 RNA ≤50 copies/ml at 48 weeks (53%, 42% and 28% respectively, p=0.07).
Croatian: Slično tome, veći udjeli djece liječene kombinacijama koje su sadržavale abakavir imali su HIV-1 RNK ≤50 kopija/ml u 48. tjednu (53%, 42% odnosno 28%, p=0,07).
English: • Ziagen must be stopped without delay, even in the absence of the HLA-B*5701 allele, if an HSR is suspected.
Croatian: • Liječenje lijekom Ziagen mora se bez odlaganja prekinuti, čak i u odsustvu alela HLA-B*5701, ako se posumnja na reakciju preosjetljivosti.
English: TAMs might be selected when thymidine analogs are associated with abacavir.
Croatian: Do selekcije mutacije analoga timidina može doći kad su analozi timidina povezani s abakavirom.
English: If abacavir is used in patients with mild hepatic impairment, then close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).
Croatian: Bolesnike s blagim oštećenjem jetre koji koriste abakavir potrebno je pažljivo pratiti, uključujući praćenje razine abakavira u plazmi, ako je moguće (vidjeti dijelove 4.4 i
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations) Harmire Road
Croatian: Glaxo Operations UK Ltd (posluje kao Glaxo Wellcome Operations) Harmire Road
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: Twice daily (300 mg) administration:
Croatian: Primjena dvaput na dan (300 mg):
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: U ispitivanje ARROW (COL105677) bilo je uključeno 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, 2006.).
English: The mean (CV) AUC over a dosing interval of 12 hours was 6.02 µg.h/ml (29%), equivalent to a daily AUC of approximately 12.0 µg.h/ml.
Croatian: Srednja vrijednost AUC-a tijekom intervala doziranja od 12 sati iznosi 6,02 µg.h/ml (koeficijent varijacije 29%), što odgovara dnevnom AUC-u od oko 12 µg.h/ml.
English: Contains amongst others: sorbitol (340 mg/ml, E420), methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
Croatian: Također sadrži: sorbitol (340 mg/ml, E420), metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216).
English: The results showed that there was a mean (90%CI) increase of 1.89 fold [1.32; 2.70] in the abacavir AUC, and 1.58 [1.22; 2.04] fold in the elimination half-life.
Croatian: Rezultati su pokazali prosječan (90% CI) porast AUC-a abakavira za 1,89 puta [1,32; 2,70], te produljenje poluvremena za 1,58 puta [1,22; 2,04].
English: The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose ; the median (range) AUC value was 24.1 (10.4 to 54.8) ug.h/ml.
Croatian: Farmakokinetika abakavira ispitivana je u bolesnika s blagim oštećenjem jetre (Child-Pugh vrijednost 5-6) koji su primili jednokratnu dozu od 600 mg; medijan (raspon) AUC vrijednosti bio je 24,1 (10,4 do 54,8) ug.h/ml.
English: Other symptoms include:
Croatian: Ostali simptomi uključuju:
English: Remove the syringe from the adapter Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek.
Croatian: Stavite štrcaljku u usta, tako da vrh štrcaljke dodiruje unutrašnju stranu obraza.
English: Metabolism and nutrition disorders Common: anorexia Very rare: lactic acidosis
Croatian: Često: anoreksija Vrlo rijetko: laktacidoza
English: ABC HSR and expand on the information already included in the currently approved EU SPC:
Croatian: Ključne poruke uključene u edukacijske materijale kako bi se poboljšalo razumijevanje i povećala svijest o ABC HSR i proširile informacije već uključene u trenutno odobreni EU SPC:
English: Take special care with Ziagen
Croatian: Budite posebno oprezni s lijekom Ziagen
English: HLA-B*5701 status must always be documented and explained to the patient prior to initiating therapy.
Croatian: HLAB*5701status mora uvijek biti dokumentiran i objašnjen bolesniku prije početka liječenja.
English: In adults treated with abacavir in combination with lamivudine and zidovudine the proportion of patients with undetectable viral load (<400 copies/ml) was approximately 70% (intention to treat analysis at 48 weeks) with corresponding rise in CD4 cells.
Croatian: U odraslih bolesnika liječenih abakavirom u kombinaciji s lamivudinom i zidovudinom, udio bolesnika s virusnim opterećenjem ispod razine detekcije (<400 kopija/ml) bio je oko 70% (analiza bolesnika s namjerom liječenja nakon 48 tjedana), uz odgovarajući porast broja CD4 stanica.
English: Ziagen contains the active ingredient abacavir.
Croatian: Ziagen sadrži djelatnu tvar abakavir.
English: This can be taken either as 300 mg (15 ml) twice a day or 600 mg (30 ml) once a day.
Croatian: Ona se može uzeti po 300 mg (15 ml) dvaput na dan ili 600 mg (30 ml) jedanput na dan.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Croatian: Zabilježeno je da se autoimuni poremećaji (npr Gravesova bolest i autoimuni hepatitis) javljaju kod imunološke reaktivacije, međutim, zabilježeno vrijeme početka je varijabilno i ovi se događaji mogu javiti mnogo mjeseci nakon početka liječenja.
English: Anyone taking Ziagen could develop a hypersensitivity reaction to abacavir, which could be life threatening if they continue to take Ziagen.
Croatian: Svatko tko uzima Ziagen može razviti reakciju preosjetljivosti na abakavir koja može ugroziti život bolesnika, ako nastavi uzimati Ziagen.
English: Any two NRTIassociated mutations Any three NRTIassociated mutations Four or more NRTIassociated mutations
Croatian: Bilo koja pojedinačna mutacija NRTI Bilo koje dvije mutacije povezane s NRTI Bilo koje tri mutacije povezane s NRTI
English: In a separate study comparing the unblinded NRTI combinations (with or without blinded nelfinavir) in children, a greater proportion treated with abacavir and lamivudine (71%) or abacavir and zidovudine (60%) had HIV-1 RNA ≤400 copies/ml at 48 weeks, compared with those treated with lamivudine and zidovudine (47%)[ p=0.09, intention to treat analysis].
Croatian: U zasebnom ispitivanju, u kojem su se uspoređivale otvorene kombinacije NRTI-ja (sa slijepim nelfinavirom ili bez njega) u djece, veći udio bolesnika liječenih abakavirom i lamivudinom (71%) ili abakavirom i zidovudinom (60%) imalo je razinu HIV-1 RNK ≤ 400 kopija/ml nakon 48 tjedana u usporedbi s onima koji su primali kombinaciju lamivudina i zidovudina (47%) [p=0,09, u analizi bolesnika s namjerom liječenja].
English: Proportions with HIV-1 RNA < 50 copies/ml (50% versus 47%) and < 400 copies/ml (54% versus 57%) were also similar in each group (ITT population).
Croatian: kopija/ml (50% naspram 47%), te onih s < 400 kopija/ml (54% naspram 57%).
English: In the as treated (AT) analysis the difference between both treatment arms was more noticeable (88% of patients in the abacavir group, compared to 95% of patients in the zidovudine group (point estimate for treatment difference: -6.8, 95% CI11.8; -1.7).
Croatian: U analizi svih liječenih bolesnika razlika između dva režima liječenja bila je još izraženija (88% bolesnika koji su uzimali abakavir, te 95% bolesnika koji su uzimali zidovudin (ocijenjena razlika liječenja: -6,8; 95% CI -11,8; -1,7).
English: Summary of Stead-State Plasma Abacavir AUC (0-24) (µg.h/ml) and Statistical Comparisons for Once and Twice-Daily Oral Administration Across Studies
Croatian: Sažetak plazmatske vrijednosti AUC(0-24) (µg.h/ml) abakavira u stanju dinamičke ravnoteže i statističke usporedbe peroralne primjene jedanput na dan u odnosu na primjenu dvaput na dan u svim ispitivanjima
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 koji u trenutku započinjanja kombinacijskog 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: In reproductive toxicity studies, embryo and foetal toxicity have been observed in rats but not in rabbits.
Croatian: U ispitivanjima reproduktivne toksičnosti, primijećena je toksičnost za razvoj embrija i fetusa u štakora, ali ne i u kunića.
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 s nepoznatim HLA-B*5701 statusom koji su prethodno dobro podnosili abakavir.
English: ARROW PK Substudy Part 1
Croatian: Farmakokinetičko podispitivanje u ispitivanju ARROW 1. dio
English: Abacavir is rapidly and well absorbed following oral administration.
Croatian: Abakavir se brzo i dobro apsorbira prilikom peroralne primjene.
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, treba odrediti je li nositelj alela HLA-B*5701 (vidjeti dio 4.4).
English: Abacavir 8 mg/kg TwiceDaily Dosing Geometric Mean (95% Cl)
Croatian: Abakavir 8 mg/kg dvaput na dan -geometrijska srednja vrijednost (95% Cl)
English: Ziagen is not recommended in patients with moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Croatian: Ziagen se ne preporučuje u bolesnika s umjerenim ili teškim oštećenjem jetre (vidjeti dijelove 4.2 i 5.2).
English: Abacavir is also excreted into human milk.
Croatian: Abakavir se također izlučuje u majčino mlijeko.
English: Plasma HIV-1 RNA <80 c/ml Risk difference (once daily-twice daily)
Croatian: HIV-1 RNK u plazmi <80 kopija/ml Razlika u riziku (jedanput na dan-dvaput na dan)
English: ZDV/3TC/ABC ZDV/3TC/EFV ZDV/3TC/ABC/EFV
Croatian: ZDV/3TC/ABC/E FV
English: As a general rule, when deciding to use antiretroviral agents for the treatment HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, both animal data as well as clinical experience in pregnant women should be taken into account.
Croatian: infekcije u trudnica, a samim time i smanjenje rizika od vertikalnog prijenosa HIV-a na novorođenče, uzmu u obzir i podaci prikupljeni u ispitivanjima na životinjama i kliničko iskustvo s trudnicama.
English: Virological Response Based on Plasma HIV-1 RNA less than 80 copies/ml at Week 48 and Week 96 in the Once Daily versus Twice Daily abacavir + lamivudine randomisation of ARROW (Observed Analysis)
Croatian: Virološki odgovor na temelju plazmatske razine HIV-1 RNK manje od 80 kopija/ml u 48. tjednu i 96. tjednu nakon randomizacije za primjenu abakavira
English: CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Ziagen if: you get a skin rash OR you get one or more symptoms from at least TWO of the following groups
Croatian: ODMAH SE JAVITE SVOM LIJEČNIKU koji će Vam savjetovati trebate li prestati uzimati Ziagen ako: dobijete osip po koži ILI
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 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 štitnjači mužjaka štakora i jetri, mokraćnom mjehuru, limfnim čvorovima i potkožnom tkivu ženki štakora.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - ORAL SOLUTION
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KARTONSKA KUTIJA - ORALNA OTOPINA
English: Carefully read all the information about hypersensitivity reactions in Section 4.
Croatian: Pozorno pročitajte sve informacije o reakcijama preosjetljivosti u dijelu 4.
English: Dosing according to weight bands is recommended for Ziagen tablets.
Croatian: Za Ziagen tablete preporučuje se doziranje prema tjelesnoj težini.
English: After a 600 mg abacavir tablet dose, the mean (CV) abacavir Cmax was approximately 4.26 µg/ml (28%) and the mean (CV) AUC∞ was 11.95 µg.h/ml (21%).
Croatian: Nakon pojedinačne doze od 600 mg abakavira, srednja vrijednost Cmax abakavira iznosi približno 4,26 µg/ml (koeficijent varijacije 28%), a srednja vrijednost AUC∞ 11,95 µg.h/ml (koeficijent varijacije 21%).
English: Abacavir is primarily metabolised by the liver with approximately 2% of the administered dose being renally excreted, as unchanged compound.
Croatian: Abakavir se primarno metabolizira u jetri, a približno 2% od primijenjene doze se eliminira nepromijenjeno renalnom ekskrecijom.
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 poznatim faktorima rizika,
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART) an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Croatian: U bolesnika zaraženih HIV-om s teškim imunološkim deficitom u vrijeme započinjanja kombinacijske antiretrovirusne terapije, može nastupiti upalna reakcija na simptomatske ili rezidualne oportunističke infekcije.
English: Therefore Ziagen can be taken with or without food.
Croatian: Stoga se Ziagen može uzimati sa ili bez hrane.
English: At week 48 the proportion of subjects with HIV RNA <50 copies/ml were 63%, 80% and 86% for the ZDV/3TC/ABC, ZDV/3TC/EFV and ZDV/3TC/ABC/EFV arms, respectively.
Croatian: U 48. tjednu je HIV RNK < 50 kopija/ml imalo 63% bolesnika koji su uzimali ZDV/3TC/ABC, 80% bolesnika koji su uzimali ZDV/3TC/EFV, te 86% bolesnika koji su uzimali ZDV/3TC/ABC/EFV.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Ziagen Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: Clinical studies have shown that there are no clinically significant interactions between abacavir, zidovudine, and lamivudine.
Croatian: Klinička ispitivanja pokazuju da nema klinički značajne interakcije između abakavira,
English: Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children (see sections 4.4 and
Croatian: Ziagen je indiciran u liječenju odraslih osoba, adolescenata i djece s infekcijom virusom humane imunodeficijencije (HIV) kao dio kombinacijske antiretrovirusne terapije (vidjeti dijelove 4.4 i 5.1).
English: In pre-clinical toxicology studies, abacavir treatment was shown to increase liver weights in rats and monkeys.
Croatian: U pretkliničkim toksikološkim ispitivanjima pokazalo se da abakavir povećava težinu jetre u štakora i majmuna.
English: Abacavir 16 mg/kg OnceDaily Dosing Geometric Mean (95% Cl)
Croatian: Abakavir 16 mg/kg jedanput na dan - geometrijska srednja vrijednost (95% Cl)