FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 17 December 2004
Croatian: Datum prvog odobrenja: 17. prosinca 2004.
English: Occasionally hypersensitivity reactions have developed in people who start taking abacavir containing products again, but who had only one symptom on the Alert Card before they stopped taking it.
Croatian: Ponekad su se reakcije preosjetljivosti razvile u osoba koje su ponovno počele uzimati lijekove koji sadrže abakavir, a imale su samo jedan simptom naveden na Kartici s upozorenjima prije nego što su ga prestale uzimati.
English: When possible, avoid chronic coadministration of Kivexa with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Croatian: Kada je moguće, izbjegavajte dugotrajnu istodobnu primjenu lijeka Kivexa i lijekova koji sadrže sorbitol ili neki drugi polialkohol ili monosaharidni alkohol s osmotskim djelovanjem (npr. ksilitol, manitol, laktitol, maltitol).
English: Importantly, such symptoms may lead to misdiagnosis of HSR as respiratory disease (pneumonia, bronchitis, pharyngitis), or gastroenteritis.
Croatian: Važno je napomenuti da takvi simptomi mogu dovesti do pogrešne dijagnoze reakcije preosjetljivosti kao bolesti dišnog sustava (pneumonije, bronhitisa, faringitisa) ili gastroenteritisa.
English: - 88.3% with ABC/3TC vs 90.3% with TDF/FTC when taken with atazanavir/ritonovir as third drug, treatment difference -2.0% (95% CI -7.5%, 3.4%), - 87.4% with ABC/3TC vs 89.2% with TDF/FTC, when taken with efavirenz as third drug, treatment difference -1.8% (95% CI -7.5%, 3.9%).
Croatian: - 88,3% s ABC/3TC u odnosu na 90,3% s TDF/FTC kada se primjenjuju s atazanavir/ritonovirom kao trećim lijekom, razlika u liječenju - 2,0% (95% Cl - 7,5%; 3,4%), - 87,4% s ABC/3TC u odnosu na 89,2% s TDF/FTC kada se primjenjuju s efavirenzom kao trećim lijekom, razlika u liječenju - 1,8% (95% Cl - 7,5%; 3,9%).
English: Those reported in at least 10% of patients with a hypersensitivity reaction are in bold text.
Croatian: Znakovi i simptomi prijavljeni u najmanje 10% bolesnika s reakcijom preosjetljivosti otisnuti su masnim slovima.
English: Mitochondrial dysfunction following exposure in utero
Croatian: Poremećaj funkcije mitohondrija nakon izložnosti in utero
English: Neither abacavir nor lamivudine were mutagenic in bacterial tests, but consistent with other nucleoside analogues, they inhibit cellular DNA replication in in vitro mammalian tests such as the mouse lymphoma assay.
Croatian: Ni abakavir ni lamivudin nisu bili mutageni u bakterijskim testovima, ali poput mnogih analoga nukleozida, oni inhibiraju replikaciju stanične DNK u testovima na sisavcima in vitro npr. na stanicama limfoma miša.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30°C
English: ANTIHISTAMINES (HISTAMINE H2 RECEPTOR ANTAGONISTS) Ranitidine/Abacavir
Croatian: ANTIHISTAMINICI (ANTAGONISTI HISTAMINSKIH H2 RECEPTORA) ranitidin/abakavir
English: If ABC hypersensitivity cannot be ruled out on clinical grounds, ABC should be permanently discontinued and should not be restarted, regardless of the results of HLA-B*5701 screening.
Croatian: U slučaju da se preosjetljivost na ABC ne može isključiti kliničkom procjenom, ABC se mora trajno isključiti iz terapije i ne smije se ponovno uvoditi, bez obzira na rezultate probira na HLA-B*5701.
English: The antiviral activity of abacavir in cell culture was not antagonized when combined with the nucleoside reverse transcriptase inhibitors (NRTIs) didanosine, emtricitabine, stavudine, tenofovir or zidovudine, the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine, or the protease inhibitor (PI) amprenavir.
Croatian: Antivirusna aktivnost abakavira u kulturi stanica nije bila antagonizirana kad se primjenjivao u kombinaciji s nukleozidnim inhibitorima reverzne transkriptaze (NRTI) didanozinom, emtricitabinom, lamivudinom, stavudinom, tenofovirom ili zidovudinom, s nenukleozidnim inhibitorom reverzne transkriptaze (NNRTI) nevirapinom ili inhibitorom proteaze (PI) amprenavirom.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack containing 90 (3 packs of 30) film-coated tablets
Croatian: OBLIK I SADRŽAJ Višestruko pakiranje koje sadrži 90 (3 pakiranja s 30) filmom obloženih tableta
English: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160 mg/800 mg once daily for 5 days/300 mg single dose)
Croatian: trimetoprim/sulfametoksazol (kotrimoksazol)/lamivudin (160 mg/800 mg jedanput dnevno tijekom 5 dana /300 mg jednokratna doza)
English: Subgroup analyses testing for heterogeneity of once versus twice daily demonstrated no significant effect of sex, age, or viral load at randomisation.
Croatian: Analize podskupina u kojima se ispitivala heterogenost doziranja jedanput na dan naspram doziranja dvaput na dan nisu pokazale značajan učinak spola, dobi ni virusnog opterećenja pri randomizaciji.
English: Read the information ‘Other possible side effects of combination therapy for HIV' in
Croatian: Pozorno pročitajte informacije “Ostale moguće nuspojave u kombiniranoj terapiji za HIV”
English: The pharmacokinetics of abacavir in patients with end-stage renal disease is similar to patients with normal renal function.
Croatian: Farmakokinetika abakavira u bolesnika s krajnjim stadijem bubrežne bolesti slična je kao u bolesnika s normalnom funkcijom bubrega.
English: Active renal secretion of lamivudine in the urine is mediated through organic cation transporters (OCTs); co-administration of lamivudine with OCT inhibitors may increase lamivudine exposure.
Croatian: Aktivna renalna sekrecija lamivudina u urin je posredovana putem transportera organskog kationa (OCT); istodobna primjena lamivudina sa OCT inhibitorima može povisiti izloženost lamivudinu.
English: Abacavir is metabolised by UDP-glucuronyltransferase (UGT) enzymes and alcohol dehydrogenase; co-administration of inducers or inhibitors of UGT enzymes or with compounds eliminated through alcohol dehydrogenase could alter abacavir exposure.
Croatian: Abakavir se metabolizira putem enzima UDP-glukoroniltransferaze (UGT) i alkoholdehidrogenaze; istodobna primjena s induktorima ili inhibitorima UGT enzima ili spojeva koji se eliminiraju putem alkoholdehidrogenaze može promijeniti izloženost abakaviru.
English: Elimination of abacavir is via hepatic metabolism with subsequent excretion of metabolites primarily in the urine.
Croatian: Eliminacija abakavira odvija se putem jetrenog metabolizma s kasnijom ekskrecijom metabolita primarno putem urina.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Ovakve reakcije su tipično zabilježene u prvih nekoliko tjedana ili mjeseci nakon uvođenja kombiniranog antiretrovirusnog liječenja.
English: Major symptoms associated with ABC HSR are fever (~80%), rash (~70%), gastrointestinal symptoms (>50%) such as nausea, abdominal pain, vomiting, and diarrhoea, generalise malaise, fatigue, and headache (~50%) and other symptoms (~30%) such as respiratory, mucosal, and musculoskeletal symptoms.
Croatian: Glavni simptomi povezani s ABC HSR su vrućica (~80%), osip (~70%), gastrointestinalni simptomi (>50%) kao što su mučnina, bol u abdomenu, povraćanje i proljev, opća malaksalost, umor i glavobolja (~50%) i ostali simptomi (~30%) kao što su respiratorni simptomi, simptomi povezani sa sluznicom, te mišićno-koštani simptomi.
English: Mechanism of action: Abacavir and lamivudine are NRTIs, and are potent selective inhibitors of HIV-1 and HIV-2 (LAV2 and EHO) replication.
Croatian: Mehanizam djelovanja: Abakavir i lamivudin su inhibitori nukleozid reverzne transkriptaze (NRTI), te su snažni selektivni inhibitori replikacije HIV-1 i HIV-2 (LAV2 i EHO).
English: Percent with <400 copies/mL vRNA
Croatian: Postotak s <400 kopija/mL vRNA
English: In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY
Croatian: U slučaju simptoma koji upućuju na reakciju preosjetljivosti ODMAH kontaktirajte svog liječnika.
English: Additionally, autoinduction of abacavir metabolism or induction of the metabolism of other medicinal products hepatically metabolised has not been observed in man.
Croatian: Osim toga, u ljudi nije zabilježena autoindukcija metabolizma abakavira niti indukcija metabolizma drugih lijekova koji se metaboliziraju u jetri.
English: Regardless of HLA-B*5701 status, patients who are diagnosed with a hypersensitivity reaction must discontinue abacavir immediately.
Croatian: Bez obzira na HLA-B*5701 status, bolesnici kojima je dijagnosticirana reakcija preosjetljivosti moraju odmah prekinuti liječenje abakavirom.
English: The inclusion of zidovudine in the regimen has been found to reduce the frequency of L74V and K65R selection in the presence of abacavir (with zidovudine: 0/40, without zidovudine: 15/192, 8%).
Croatian: Ustanovljeno je da uključenje zidovudina u terapiju smanjuje učestalost selekcije L74V i K65R u prisustvu abakavira (sa zidovudinom: 0/40, bez zidovudina: 15/192, 8%).
English: The metabolites and unchanged abacavir account for about 83% of the administered abacavir dose in the urine.
Croatian: Metaboliti i nepromijenjeni abakavir čine oko 83% ukupne primijenjene doze koja se izlučuje urinom.
English: Abacavir and lamivudine are rapidly and well absorbed from the gastro-intestinal tract following oral administration.
Croatian: Abakavir i lamivudin se brzo i dobro apsorbiraju iz gastrointestinalnog sustava nakon oralne primjene.
English: Carefully read all the information about hypersensitivity reactions in Section 4 of this leaflet.
Croatian: Pozorno pročitajte sve informacije o reakcijama preosjetljivosti u dijelu 4 ove Upute.
English: No antagonistic effects in vitro were seen with lamivudine and other antiretrovirals (tested agents:didanosine, nevirapine and zidovudine).
Croatian: Nisu primijećeni antagonistički učinci in vitro s primjenom lamivudina i ostalih antiretrovirotika (testirani lijekovi: didanozin, nevirapin i zidovudin).
English: Within this population, 104 patients, weighing at least 25 kg, received 600 mg abacavir and 300 mg lamivudine as Kivexa once daily, with a median duration of exposure of 596 days.
Croatian: Unutar te populacije 104 bolesnika, tjelesne težine od najmanje 25 kg, primilo je 600 mg abakavira i 300 mg lamivudina jedanput na dan kao lijek Kivexa, sa medijanom trajanja izloženosti lijeku od 596 dana.
English: The results are summarised by subgroup in the table below:
Croatian: Rezultati su sažeti prema podgrupama u tablici:
English: Kivexa is not recommended in patients with moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Croatian: Kivexa se ne preporučuje u bolesnika s umjerenim ili teškim oštećenjem jetre (vidjeti dijelove 4.2 i 5.2).
English: The overall selection frequency for M184V or M184I was high (54%), and less common was the selection of L74V (5%), K65R (1%) and Y115F (1%) (see table below).
Croatian: Ukupna učestalost selekcije M184V ili M184I je bila visoka (54%) dok su manje česte bile selekcije L74V (5%), K65R (1%) i Y115F (1%) (vidjeti
English: Tell your doctor or pharmacist if you are taking any of these.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od navedenih lijekova.
English: (see reverse of card)
Croatian: (pogledajte drugu stranu)
English: Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdose, although this has not been studied.
Croatian: Budući da se lamivudin može ukloniti dijalizom, predoziranje se može liječiti kontinuiranom hemodijalizom iako ta mjera do sada nije bila ispitivana.
English: You must carefully read all the information under ‘Hypersensitivity reactions' in the panel in Section 4.
Croatian: Pažljivo pročitajte sve informacije u okviru “Reakcije preosjetljivosti” u dijelu 4.
English: If you notice any of these symptoms contact a doctor urgently.
Croatian: Ako primijetite bilo koji od navedenih simptoma hitno obavijestite liječnika.
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 o vezanju na proteine plazme in vitro pokazuju da se abakavir u terapijskim koncentracijama veže slabo do umjereno (∼49%) na proteine ljudske plazme.
English: Readily available genotypic drug resistance interpretation algorithms and commercially available susceptibility tests have established clinical cut offs for reduced activity for abacavir and lamivudine as separate drug entities that predict susceptibility, partial susceptibility or resistance based upon either direct measurement of susceptibility or by calculation of the HIV-1 resistance phenotype from the viral genotype.
Croatian: Dostupni algoritmi za interpretaciju genotipske rezistencije lijekova kao i komercijalno dostupni testovi osjetljivosti utvrdili su kliničke kriterije za smanjenu aktivnost abakavira i lamivudina kao odvojenih entiteta lijekova za predviđanje osjetljivosti, djelomične osjetljivosti ili rezistencije temeljem bilo izravnog mjerenja osjetljivosti, ili izračuna HIV-1 rezistencijskog fenotipa iz virusnog genotipa.
English: • breakdown of muscle tissue.
Croatian: • razgradnja mišićnog tkiva.
English: 3 years.
Croatian: 3,4 puta.
English: Kivexa should not be administered to children who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced.
Croatian: Kivexa se ne smije primijeniti u djece tjelesne težine manje od 25 kg jer je kombinacija doza u jednoj tableti fiksna i ne može se smanjiti.
English: The exception was the preputial gland tumour which occurred at a dose of 110 mg/kg in mice.
Croatian: Izuzetak je tumor prepucijske žlijezde koji se javljao pri dozi od 110 mg/kg u miševa.
English: Orange, film-coated, modified capsule shaped tablets, debossed with GS FC2 on one side.
Croatian: Narančaste filmom obložene tablete oblika kapsule s utisnutom oznakom GS FC2 na jednoj strani.
English: In such cases medicinal products containing abacavir should be permanently discontinued.
Croatian: U takvim se slučajevima mora trajno obustaviti liječenje lijekovima koji sadrže abakavir.
English: Some people taking Kivexa or other combination treatments for HIV are more at risk of serious side effects.
Croatian: Neki bolesnici koji uzimaju lijek Kivexa ili drugu kombiniranu terapiju za HIV su pod većim rizikom od razvoja ozbiljnih nuspojava.
English: The combination of abacavir and lamivudine has demonstrated antiviral activity in cell culture against non-subtype B isolates and HIV-2 isolates with equivalent antiviral activity as for subtype B isolates.
Croatian: Kombinacija abakavira i lamivudina pokazala je ekvivalentno antivirusno djelovanje u staničnim kulturama prema izolatima koji nisu pripadali podtipu B kao i prema HIV-2 izolatima sa ekvivalentnom antiviralnom aktivnošću kao prema onima samog podtipa B.
English: Both abacavir and lamivudine have been shown to inhibit replication of laboratory 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 lymphocytes (PBLs) and monocyte/macrophages.
Croatian: Pokazalo se da i abakavir i lamivudin inhibiraju replikaciju laboratorijskih sojeva i kliničkih izolata HIVa kod različitih vrsta stanica, uključujući transformirane stanične linije T limfocita, stanične linije nastale od monocita/makrofaga i primarne kulture aktiviranih limfocita iz periferne krvi (PBLs) i monocita/makrofaga.
English: At week 48, a lower rate of virologic response was observed for ABC/3TC compared to TDF/FTC (point estimate for the treatment difference: 11.6%, 95% CI: 2.2, 21.1).
Croatian: U 48 tjednu, niža stopa virološkog odgovora je uočena kod ABC/3TC u usporedbi s TDF/FTC (točna procijenjena razlika u liječenju: 11,6%; 95% Cl: 2,2; 21,1).
English: Methadone/Abacavir (40 to 90mg once daily for 14 days/600mg single dose, then 600mg twice daily for 14 days)
Croatian: OPIOIDI metadon/abakavir (40 do 90 mg jedanput dnevno tijekom 14 dana/ 600 mg jednokratna doza, zatim 600 mg dva puta dnevno tijekom 14 dana)
English: A genotypic sensitivity score (GSS) has not been established by the MAH for the abacavir/lamivudine combination.
Croatian: Indeks genotipske osjetljivosti (GSS) nije utvrđen putem MAH-a za kombinaciju abakavir/lamivudin.
English: The adverse reactions reported for Kivexa were consistent with the known safety profiles of abacavir and lamivudine when given as separate medicinal products.
Croatian: Nuspojave zabilježene kod primjene lijeka Kivexa u skladu su s poznatim profilima sigurnosti abakavira i lamivudina kad se daju kao zasebni lijekovi.
English: Kivexa contains the azo colouring agent sunset yellow, which may cause allergic reactions.
Croatian: Kivexa sadrži narančastožuto azo-bojilo „sunset yellow“, koje može prouzročiti alergijsku reakciju.
English: The carcinogenic potential of a combination of abacavir and lamivudine has not been tested.
Croatian: Kancerogeni potencijal kombinacije abakavira i lamivudina nije ispitivan.
English: • In order to avoid restarting abacavir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Kivexa tablets
Croatian: • Kako bi se izbjeglo ponovno uzimanje abakavira, bolesnike koji su imali suspektnu reakciju preosjetljivosti mora se uputiti da zbrinu preostale Kivexa tablete.
English: Your doctor may need to monitor you while you are taking Kivexa.
Croatian: Liječnik bi Vas trebao nadzirati dok uzimate lijek Kivexa.
English: Common: Arthralgia, muscle disorders
Croatian: Često: artralgija, mišićni poremećaji
English: The Data Safety Monitoring Board (DSMB) recommended that consideration be given to change in the therapeutic management of all subjects in the high viral load stratum due to the efficacy differences observed.
Croatian: Monitoring Board - DSMB) preporučio je da se razmotri promjena u liječenju kod svih bolesnika s visokim viralnim opterećenjem.
English: In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the development of M184V might provide residual anti-retroviral activity (likely through impaired viral fitness).
Croatian: Podaci in vitro ukazuju da bi se nastavkom primjene lamivudina unatoč razvoju M184V moglo osigurati rezidualno antiretrovirusno djelovanje (vjerojatno zbog oštećenja virusa).
English: Carcinogenicity studies with orally administered abacavir in mice and rats showed an increase in the incidence of malignant and non-malignant tumours.
Croatian: Ispitivanja kancerogenosti oralno primijenjenog abakavira u miševa i štakora pokazala su porast incidencije malignih i nemalignih tumora.
English: Risk of virological failure
Croatian: Rizik od izostanka virološkog odgovora
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON BLISTER PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA BLISTER PAKIRANJA
English: Patients should be advised that Kivexa or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Croatian: Bolesnici koji uzimaju lijek Kivexa ili bilo koju drugu antiretrovirusnu terapiju, mogu i dalje razvijati oportunističke infekcije i druge komplikacije HIV infekcije.
English: If lamivudine is being used concomitantly for the treatment of HIV and hepatitis B virus (HBV), additional information relating to the use of lamivudine in the treatment of hepatitis B infection can be found in the Summary of Product Characteristics for products containing lamivudine that are indicated for the treatment of HBV.
Croatian: Ako se lamivudin istodobno koristi za liječenje infekcije HIV-om i virusom hepatitisa B (HBV), dodatne informacije o uporabi lamivudina u liječenju hepatitisa B dostupne su u Sažetku opisa svojstava lijeka za lijekove koji sadrže lamivudin i indicirani su za liječenje HBV-a.
English: The majority of these tumours occurred at the highest abacavir dose of 330 mg/kg/day in mice and 600 mg/kg/day in rats.
Croatian: Većina tih tumora nastala je pri najvišim dozama abakavira od 330 mg/kg/dan u miševa i
English: HLA-B*5701 screening for risk of ABC hypersensitivity should never be substituted for appropriate clinical vigilance and patient management in individuals receiving ABC.
Croatian: Probir na HLA-B*5701 radi određivanja rizika od preosjetljivosti na ABC nikad ne smije biti zamjena za odgovarajuće kliničko praćenje i zbrinjavanje osoba koje uzimaju ABC.
English: Pharmacogenetic Testing
Croatian: Farmakogenetsko testiranje
English: After 36 weeks on a regimen including twice daily abacavir and lamivudine, 669 eligible subjects were randomised to either continue twice daily dosing or switch to once daily abacavir and lamivudine for at least an additional 96 weeks.
Croatian: Nakon 36 tjedana liječenja režimom koji je uključivao primjenu abakavira i lamivudina dvaput na dan, 669 za to prikladnih ispitanika bilo je randomizirano ili za nastavak liječenja uz doziranje dvaput na dan ili za prelazak na liječenje abakavirom i lamivudinom jedanput na dan tijekom najmanje 96 tjedana.
English: High doses of trimethoprim/ sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis have not been studied and should be avoided
Croatian: sulfametoksazola za liječenje pneumonije uzrokovane Pneumocystis jirovecii (PCP) i toksoplazmoze nisu do sada proučavane, te bi ih svakako trebalo izbjegavati.
English: Therefore patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases.
Croatian: Stoga te bolesnike mora pažljivo nadzirati liječnik koji ima iskustva u liječenju bolesti povezanih s HIV infekcijom.
English: A fertility study in rats has shown that abacavir and lamivudine had no effect on male or female fertility.
Croatian: Ispitivanja o fertilnosti u štakora pokazuju da abakavir i lamivudin nisu imali učinaka na fertilnost mužjaka ni ženki.
English: HSRs have been observed 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: There was a low, similar overall incidence of virologic failure (viral load > 50 copies/ml) in both the once and twice daily treatment groups (10% and 8% respectively).
Croatian: Zabilježena je mala ukupna incidencija izostanka virološkog odgovora (virusno opterećenje > 50 kopija/ml), slična u obje skupine (10% u skupini liječenoj jedanput na dan i 8% u skupini liječenoj dvaput na dan).
English: Drugs by Therapeutic Area Interaction Geometric mean change (%) (Possible mechanism)
Croatian: Interakcija geometrijska sredina promjene (%)
English: • development of 1 or more symptom from at least 2 of the following groups: - Fever - Shortness of breath, sore throat or cough - Nausea or vomiting or diarrhoea or abdominal pain - Extreme tiredness or achiness or general ill feeling
Croatian: • razvoja 1 ili više simptoma iz najmanje 2 od sljedećih grupa: - vrućica - kratkoća daha, grlobolja ili kašalj - mučnina ili povraćanje ili proljev ili bol u abdomenu - izraziti umor ili bolnost ili opće loše stanje
English: This was demonstrated in a single dose, 3-way crossover bioequivalence study of FDC (fasted) versus 2 x 300 mg abacavir tablets plus 2 x 150 mg lamivudine tablets (fasted) versus FDC administered with a high fat meal, in healthy volunteers (n = 30).
Croatian: To je dokazano u trosmjernoj križanoj studiji bioekvivalencije s jednom dozom FDC-a uzetom na tašte nasuprot 2 x 300 mg abakavira i 2 x 150 mg lamivudina tableta (natašte) nasuprot FDC uz visokokalorični obrok u zdravih dragovoljaca (n=30).
English: Do not take Kivexa:
Croatian: Nemojte uzimati lijek Kivexa: