FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients receiving lamivudine 300 mg once daily, the terminal intracellular half-life of lamivudine-TP was prolonged to 16-19 hours, compared to the plasma lamivudine half-life of 5-7 hours.
Croatian: Za bolesnike koji dobivaju lamivudin u dozi od 300 mg jedanput na dan, terminalni unutarstanični poluvijek lamivudin-TP-a bio je produljen na 1619 sati u usporedbi s poluvijekom lamivudina u plazmi od 5-7 sati.
English: However, as there were only moderately experienced patients included in this study with an imbalance in baseline viral load between the arms, these results should be interpreted with caution.
Croatian: Međutim, budući da su u ispitivanje bili uključeni bolesnici koji su prethodno samo umjereno liječeni te da početno virusno opterećenje u dvije ispitivane skupine nije bilo uravnoteženo, pri interpretaciji ovih rezultata potreban je oprez.
English: Tell your doctor if you are being treated with any of these.
Croatian: Obavijestite svog liječnika ako se liječite bilo kojim od navedenih lijekova.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, predominantly by renal clearance (> 70%) via the organic cationic transport system.
Croatian: Srednja vrijednost sistemskog klirensa lamivudina iznosi oko 0,32 l/h/kg, najvećim dijelom bubrežnim klirensom (>70%) preko organskog kationskog transportnog sistema.
English: Even patients who don't have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction), described in this leaflet in the panel headed ‘Hypersensitivity reactions'.
Croatian: Čak i u bolesnika koji nemaju gen HLA-B*5701 može se razviti reakcija preosjetljivosti (ozbiljna alergijska reakcija), koja se u ovoj Uputi opisuje u posebno označenom okviru “Reakcije preosjetljivosti”.
English: Similar reactions have also occurred infrequently after restarting abacavir in patients who had only one of the key symptoms of hypersensitivity (see above) prior to stopping abacavir; and on very rare occasions have also been seen in patients who have restarted therapy with no preceding symptoms of a HSR (i.e., patients previously considered to be abacavir tolerant).
Croatian: Slične su se reakcije povremeno javljale i nakon ponovnog uvođenja abakavira u bolesnika koji su prije prekida liječenja abakavirom imali samo jedan od ključnih simptoma preosjetljivosti (vidjeti gore), a u vrlo rijetkim su se slučajevima takve reakcije pojavile i nakon ponovnog uvođenja terapije u bolesnika koji prethodno nisu imali simptome reakcije preosjetljivosti (tj. bolesnika za koje se prethodno smatralo da dobro podnose abakavir).
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 povećanoj stopi mutacija povezanih s NRTI pri doziranju abakavira jedanput na dan u odnosu na doziranje dvaput na dan.
English: Kivexa contains abacavir (which is also an active substance in medicines such as Trizivir, Triumeq and Ziagen).
Croatian: Kivexa sadrži abakavir (koji je također djelatna tvar u lijekovima kao što su Trizivir, Triumeq i Ziagen).
English: Cmax ↓ 28%; 52%, 55%.
Croatian: AUC ↓ 14%; 32%; 36% Cmax ↓ 28%; 52%, 55%.
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: Ostali simptomi uključuju: 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: Restarting abacavir in such patients must be done in a setting where medical assistance is readily available.
Croatian: U tih se bolesnika ponovno liječenje abakavirom smije započeti samo u okruženju u kojem je odmah dostupna liječnička pomoć.
English: No firm conclusion could be drawn due to the limited data derived from this study.
Croatian: Zbog ograničenih podataka iz ovog ispitivanja ne mogu se izvući čvrsti zaključci.
English: Studies with lamivudine show that plasma concentrations (AUC) are increased in patients with renal dysfunction due to decreased clearance.
Croatian: Ispitivanja s lamivudinom pokazuju da su zbog smanjenog klirensa koncentracije u plazmi povećane (AUC) u bolesnika s oštećenjem bubrežne funkcije.
English: Observational studies have shown an association between myocardial infarction and the use of abacavir.
Croatian: Opservacijske studije su pokazale povezanost infarkta miokarda s uporabom abakavira.
English: Antiviral therapy According to Genotypic/Phenotypic Resistance
Croatian: Antivirusna terapija prema genotipskoj/fenotipskoj otpornosti
English: Driving and using machines Kivexa may cause side effects which could affect your ability to drive or use machines.
Croatian: Kivexa može uzrokovati nuspojave koje bi mogle utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: These findings included decreased foetal body weight, foetal oedema, and an increase in skeletal variations/malformations, early intra-uterine deaths and still births.
Croatian: Ovi nalazi uključuju smanjenu fetalnu tjelesnu težinu, fetalni edem i porast varijacija/malformacija kostura, rane intrauterine smrtnosti i mrtvorođenčadi.
English: Overall, these data support the use of lamivudine 300 mg and abacavir 600 mg once daily for the treatment of HIV-infected patients.
Croatian: Općenito, ovi podaci podupiru primjenu lamivudina u dozi od 300 mg i abakavira u dozi od 600 mg jedanput na dan u liječenju bolesnika s HIV infekcijom.
English: Abacavir is also excreted into human milk.
Croatian: Abakavir se izlučuje i u majčino mlijeko ljudi.
English: The tablet coating contains Opadry Orange YS-1-13065-A containing hypromellose, titanium dioxide, macrogol 400, polysorbate 80 and sunset yellow FCF (E110).
Croatian: Ovojnica tablete sadrži „Opadry Orange YS-1-13065-A” koji sadrži hipromelozu, titanijev dioksid, makrogol 400, polisorbat 80 i boju “sunset yellow FCF ” (E110).
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Croatian: U bolesnika koji već boluju od poremećaja funkcije jetre, uključujući kronični aktivni hepatitis, češće su zabilježene abnormalnosti funkcije jetre tijekom kombiniranog antiretrovirusnog liječenja te se takve bolesnike mora pratiti prema uobičajenoj praksi.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek Kivexa Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: The results of an in vivo rat micronucleus test with abacavir and lamivudine in combination were negative.
Croatian: Rezultati mikronukleusnog testa u štakora in vivo s kombinacijom abakavira i lamivudina bili su negativni.
English: These symptoms usually resolve upon discontinuation of abacavir.
Croatian: Ti se simptomi obično povlače nakon prekida liječenja abakavirom.
English: K65R was absent and L74V and Y115F were uncommon (≤3%).
Croatian: Nije ustanovljen K65R, dok su se L74V i Y115F javili manje često (≤3%).
English: No specific symptoms or signs have been identified following acute overdose with abacavir or lamivudine, apart from those listed as undesirable effects.
Croatian: Nisu uočeni nikakvi specifični simptomi niti znakovi kao posljedica akutnog predoziranja abakavirom ili lamivudinom, osim onih navedenih u dijelu o nuspojavama.
English: Common: anorexia Very rare: lactic acidosis
Croatian: Često: anoreksija Vrlo rijetko: laktacidoza
English: Even patients who don't have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction)
Croatian: Čak i u bolesnika koji nemaju gen HLA-B*5701 može se razviti reakcija preosjetljivosti (ozbiljna alergijska reakcija).
English: The mean time to maximal serum concentrations (tmax) is about 1.5 hours and 1.0 hour for abacavir and lamivudine, respectively.
Croatian: Srednje vrijeme (tmax) u kojem se postiže maksimalna koncentracija u serumu je oko 1,5 sati za abakavir i 1 sat za lamivudin.
English: The safety database to support once daily dosing in paediatric patients comes from the ARROW Trial (COL105677) in which 669 HIV-1 infected paediatric subjects (from 12 months to ≤17 years old).
Croatian: Baza podataka o sigurnosti koja podržava doziranje jedanput na dan u pedijatrijskih bolesnika dolazi iz ispitivanja ARROW (COL105677) u kojem je 669 pedijatrijskih ispitanika zaraženih s HIV-1 (u dobi od 12 mjeseci do ≤17 godina) primalo abakavir i lamivudin jedanput ili dvaput na dan (vidjeti dio 5.1).
English: Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir.
Croatian: Probir se također preporučuje i prije ponovnog uvođenja abakavira u bolesnika nepoznatog HLA-B*5701 statusa koji su prethodno podnosili abakavir.
English: Passage with a zidovudine resistant clinical isolate RTMC also selected for the 184V mutation.
Croatian: Prolaskom kliničkog izolata RTMC koji je rezistentan na zidovudin također se došlo do 184V mutacije.
English: HLA-B*5701 status must always be documented and explained to the patient prior to initiating therapy.
Croatian: 5701 status mora uvijek biti dokumentiran i objašnjen bolesniku prije početka liječenja.
English: Do not take this medicine after the expiry date shown on the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake „EXP“.
English: Isolates from most patients experiencing virological failure with a regimen containing abacavir in pivotal clinical trials showed either no NRTI-related changes from baseline (45%) or only M184V or M184I selection (45%).
Croatian: Izolati većine bolesnika iz ključnih kliničkih ispitivanja, u kojih je uz terapiju koja sadrži abakavir izostao virološki odgovor, pokazali su ili nikakav pomak od početnih vrijednosti povezan s NRTI (45%) ili samo selekciju M184V ili M184I (45%).
English: Myalgia, rarely myolysis, arthralgia, elevated creatine phosphokinase
Croatian: Mišićno-koštani sustav mialgija, rijetko mioliza, artralgija, povišene razine kreatin fosfokinaze
English: Passage of HIV-1 (HXB2) in the presence of increasing 3TC concentrations results in high-level (>100 to >500-fold) lamivudine-resistant viruses and the RT M184I or V mutation is rapidly selected.
Croatian: Prolaz HIV-1 (HXB2) kroz postupno povećavanu 3TC koncentraciju rezultiralo je virusima koji su rezistentni na lamivudin u visokoj razini (>100 do >500-puta) s brzim odabirom mutacije RT M184I ili
English: Both abacavir and lamivudine are metabolised sequentially by intracellular kinases to the respective 5'-triphosphate (TP) which are the active moieties.
Croatian: I abakavir i lamivudin se metaboliziraju dosljedno intrastaničnom kinazom u svoje aktivne metabolite, 5'-trifosfate (TP) koji su aktivni spojevi.
English: • liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
Croatian: • poremećaji jetre, kao što su „žutica“, povećana ili „masna“ jetra, upala (hepatitis)
English: For patients co-infected with hepatitis who are being treated with a lamivudine containing medicinal product such as Kivexa and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.
Croatian: Za bolesnice istodobno zaražene virusom hepatitisa, a koje su liječene s lijekovima koji sadrže lamivudin, kao što je Kivexa te u međuvremenu zatrudne, mora se razmotriti mogućnost recidiva hepatitisa prilikom obustave terapije lamivudinom.
English: In a crossover study in 27 HIV-infected patients, intracellular carbovir-TP exposures were higher for the abacavir 600 mg once daily regimen (AUC24,ss + 32%, Cmax24,ss + 99% and Ctrough + 18%) compared to the 300 mg twice daily regimen.
Croatian: U križnoj studiji 27 bolesnika zaraženih virusom HIV-a, unutarstanična izloženost karbovir-TP-u bila je veća pri doziranju od 600 mg abakavira jedanput na dan (AUC24,ss + 32 %, Cmax24,ss + 99 % and Ctrough + 18 %) u usporedbi s 300 mg dvaput na dan.
English: Data obtained in patients with moderate to severe hepatic impairment show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Croatian: Podaci dobiveni u bolesnika s umjerenim i teškim oštećenjem jetre pokazuju da oštećenje jetrene funkcije ne utječe značajno na farmakokinetiku lamivudina.
English: This recurrence is usually more severe than on initial presentation, and may include life-threatening hypotension and death.
Croatian: Ponovna reakcija obično je još teža nego prvotna, a može uključivati po život opasnu hipotenziju i smrt.
English: It is important to take Kivexa regularly, because if you take it at irregular intervals, you may be more likely to have a hypersensitivity reaction.
Croatian: Važno je da lijek Kivexa uzimate redovito jer neredovito uzimanje može povećati rizik od reakcije preosjetljivosti.
English: Rash (usually maculopapular or urticarial)
Croatian: Koža osip (obično makulopapularni ili urtikarijski)
English: Many of the adverse reactions listed in the table below occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity.
Croatian: Mnoge od nuspojava navedenih u tablici u nastavku javljaju se često (mučnina, povraćanje, proljev, vrućica, letargija, osip) u bolesnika preosjetljivih na abakavir.
English: If you forget to take Kivexa
Croatian: Ako ste zaboravili uzeti lijek Kivexa
English: MISCELLANEOUS Ethanol/Abacavir (0.7 g/kg single dose/600 mg single dose)
Croatian: OSTALO etanol/abakavir (0,7 g/kg jednokratna doza/600mg jednokratna doza)
English: These resulted in median EC50 values of 0.912 µM (range: 0.493 to 5.017 µM) and 1.26 µM (range 0.72 to 1.91 µM) respectively for abacavir, and median EC50 values of 0.429 µM (range: 0.200 to 2.007 µM) and 2.38 µM (1.37 to 3.68 µM) respectively for lamivudine.
Croatian: To je rezultiralo medijanom vrijednosti EC50 od 0,912 µM (raspon: 0,493 do 5,017 µM) i 1,26 µM (raspon 0,72 do 1,91 µM) za abakavir, i vrijednost medijana EC50 od 0,429 µM (raspon: 0,200 do 2,007 µM) i 2,38 µM (1,37 do 3,68 µM) za lamivudin.
English: In vivo resistance (Therapy experienced patients)
Croatian: Rezistencija in vivo (prethodno liječeni bolesnici)
English: Paediatric pharmacokinetic studies have demonstrated that once daily dosing provides equivalent AUC24 to twice daily dosing of the same total daily dose for both oral solution and tablet formulations.
Croatian: Ispitivanja pedijatrijske farmakokinetike pokazala su da doziranje jedanput na dan daje AUC24 ekvivalentan doziranju dvaput na dan pri istoj sveukupoj dnevnoj dozi i za formulaciju oralne otopine i za formulaciju tablete.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Croatian: U bolesnika zaraženih HIV-om s teškim imunološkim deficitom u vrijeme započinjanja kombinirane antiretrovirusne terapije, može nastupiti upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; 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: Zabilježeno je da se autoimuni poremećaji (kao što je Gravesova bolest i autoimuni hepatitis) javljaju kod imune reaktivacije, međutim, zabilježeno vrijeme početka je varijabilno te se ovi događaji mogu javiti mnogo mjeseci nakon početka liječenja (vidjeti dio 4.4).
English: Group O isolates from antiviral naïve patients tested for lamivudine activity were highly sensitive.
Croatian: Izolati skupine O koji su dobiveni od bolesnika koji nisu primali antivirusnu terapiju bili su visoko osjetljivi na ispitivanu aktivnost lamivudina.
English: Potential to slightly decrease abacavir plasma concentrations through UGT induction.
Croatian: Potencijalno lagano smanjivanje koncentracije abakavira u plazmi zbog UGT indukcije
English: Following a single dose of 600 mg of abacavir, the mean (CV) Cmax is 4.26 µg/ml (28%) and the mean (CV) AUC∞ is 11.95 µg.h/ml (21%).
Croatian: Nakon pojedinačne doze od 600 mg abakavira, srednji Cmax iznosi 4,26 µg/ml (koeficijent varijacije (CV) 28%), a srednji AUC∞ 11,95 µg.h/ml (CV 21%).
English: If you have discontinued Kivexa due to this reaction, YOU MUST NEVER TAKE Kivexa, or any medicine containing abacavir (e.g. Ziagen,Triumeq or Trizivir) again as within hours you may experience a life-threatening lowering of your blood pressure or death.
Croatian: Ako ste zbog takve reakcije prestali uzimati lijek Kivexa, VIŠE NIKADA NE SMIJETE UZIMATI lijek Kivexa niti druge lijekove koji sadrže abakavir (npr. Ziagen, Triumeq ili Trizivir), jer se unutar nekoliko sati može razviti po život opasno sniženje krvnog tlaka ili smrt.
English: Since Kivexa contains abacavir some patients taking Kivexa may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if treatment with Kivexa is continued.
Croatian: Budući da Kivexa sadrži abakavir, neki bolesnici koji uzimaju lijek Kivexa mogu razviti reakciju preosjetljivosti (ozbiljnu alergijsku reakciju) koja može biti opasna po život ako se nastavi s uzimanjem lijeka Kivexa.
English: In a crossover study in 60 healthy volunteers, intracellular lamivudine-TP pharmacokinetic parameters were similar (AUC24,ss and Cmax24,ss) or lower (Ctrough - 24%) for the lamivudine 300 mg once daily regimen compared to the lamivudine 150 mg twice daily regimen.
Croatian: zdravih dobrovoljaca, unutarstanični farmakokinetski parametri lamivudina-TP bili su slični (AUC24,ss i Cmax24,ss) ili niži (Ctrough - 24 %) kad je lamivudin primijenjen u dozi od 300 mg jedanput na dan u odnosu na doziranje 150 mg dvaput 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 (kao što je Gravesova bolest i autoimuni hepatitis) javljaju kod imune reaktivacije, međutim, zabilježeno vrijeme početka je varijabilno te se ovi događaji mogu javiti mnogo mjeseci nakon početka liječenja.
English: • Kivexa must be stopped without delay, even in the absence of the HLA-B*5701 allele, if an HSR is suspected.
Croatian: • Liječenje lijekom Kivexa mora se bez odlaganja prekinuti, čak i u odsustvu alela HLA-B*5701, ako se posumnja na reakciju preosjetljivosti.
English: They were randomised to receive either abacavir (ABC) 600 mg once daily or 300 mg twice daily, in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily.
Croatian: Oni su randomizirani u dvije skupine koje su primale ili abakavir (ABC) 600 mg jedanput na dan ili abakavir 300 mg dvaput na dan u kombinaciji s lamivudinom 300 mg jedanput na dan i efavirenzom 600 mg jedanput na dan.
English: The fixed-dose combination tablet of abacavir/lamivudine (FDC) has been shown to be bioequivalent to lamivudine and abacavir administered separately.
Croatian: Dokazano je kako je fiksna kombinacija abakavir/lamivudin (FDC) bioekvivalentna odvojenoj primjeni lamivudina i abakavira.
English: Excipient(s) with known effect: sunset yellow FCF (E110) 1.7 mg per tablet For the full list of excipients see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: sunset yellow FCF (E110) 1,7 mg po tableti.
English: A comparison of a regimen including once daily versus twice daily dosing of abacavir and lamivudine was undertaken within a randomised, multicentre, controlled study of HIV-infected, paediatric patients.
Croatian: Pedijatrijska populacija Usporedba režima primjene abakavira i lamivudina jedanput na dan u odnosu na primjenu dvaput na dan provedena je u sklopu randomiziranog, multicentričnog, kontroliranog ispitivanja pedijatrijskih bolesnika zaraženih HIV-om.
English: Among the 669 subjects randomized in this study (from 12 months to ≤17 years old), the abacavir/lamivudine once daily dosing group was demonstrated to be non-inferior to the twice daily group according to the pre-specified non-inferiority margin of -12%, for the primary endpoint of <80 c/mL at Week 48 as well as at Week 96 (secondary endpoint) and all other thresholds tested (<200c/mL, <400c/mL, <1000c/mL), which all fell well within this non-inferiority margin.
Croatian: Od 669 ispitanika randomiziranih u tom ispitivanju (u dobi od 12 mjeseci do ≤ 17 godina), skupina koja je primala abakavir/lamivudin jedanput na dan bila je neinferiorna skupini koja je primala te lijekove dvaput na dan, prema unaprijed određenoj granici neinferiornosti od -12% za primarnu mjeru ishoda od <80 kopija/ml u 48. tjednu, kao i u 96. tjednu (sekundarna mjera ishoda), i za sve ostale ispitivane granične vrijednosti (<200 kopija/ml, <400 kopija/ml, <1000 kopija/ml), koje su se sve nalazile značajno unutar spomenute granice neinferiornosti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/298/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/298/002
English: Common: Cough, nasal symptoms
Croatian: Često: kašalj, nazalni simptomi
English: As well as the side effects listed below for Kivexa, other conditions can develop during combination therapy for HIV.
Croatian: Kao i niže navedene nuspojave za lijek Kivexa i druga stanja se mogu razviti za vrijeme kombinirane terapije za HIV.
English: The Kivexa pack includes an Alert Card, to remind you and medical staff about hypersensitivity reactions.
Croatian: Pakiranje lijeka Kivexa sadrži Karticu s upozorenjima, koja služi da Vas i zdravstvene djelatnike podsjeti na reakcije preosjetljivosti.
English: Abacavir demonstrated toxicity to the developing embryo and foetus in rats, but not in rabbits.
Croatian: Abakavir je pokazao toksičnost za razvoj embrija i fetusa u štakora, ali ne i u zečeva.
English: Clinical experience with the combination of abacavir and lamivudine as a once daily regimen is mainly based on four studies in treatment-naïve subjects, CNA30021, EPZ104057 (HEAT study), ACTG5202, and CNA109586 (ASSERT study) and two studies in treatment-experienced subjects, CAL30001 and ESS30008.
Croatian: Kliničko iskustvo Kliničko iskustvo sa kombinacijom abakavira i lamivudina u jednodnevnom režimu se većinom bazira na četiri ispitivanja na prethodno neliječenim bolesnicima, CNA30021, EPZ104057 (HEAT ispitivanje), ACTG5202, te CNA109586 (ASSERT ispitivanje) i dva ispitivanja u prethodno liječenim bolesnicima CAL30001 i ESS30008.
English: They are orange and capsuleshaped and are provided in blister packs containing 30 tablets and multipack blister packs containing 90(3 x 30) tablets.
Croatian: Narančaste su boje i oblika kapsule, a dostupne su u blister pakiranjima od 30 tableta i višestrukim blister pakiranjima od 90 (3 x 30) tableta.
English: IMPORTANT - Hypersensitivity reactions
Croatian: VAŽNO - Reakcije preosjetljivosti
English: Kivexa should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine.
Croatian: Interakcije s drugim lijekovima Kivexa se ne smije uzimati sa drugim lijekovima koji sadrže lamivudin ili emtricitabin.
English: Rare: pancreatitis has been reported, but a causal relationship to abacavir treatment is uncertain
Croatian: proljev Rijetko: zabilježen je pankreatitis, ali uzročna povezanost s liječenjem abakavirom nije sigurna
English: Patients were stratified at screening based on plasma HIV-1 RNA levels < 100,000 and ≥ 100,000 copies/mL.
Croatian: Bolesnici su odabrani na temelju probira temeljenog na razini HIV-1 RNK <100 000 i ≥100 000 kopija/ml u plazmi.