FrancophonIA/ELRC3.0 huggingface dataset:
English: The partial patient subset of data available for CNA30021 is tabulated below,
Croatian: Djelomična podskupina podataka o bolesnicima iz CNA30021 je tablično prikazana, no mora ih se interpretirati s oprezom.
English: Baseline Reverse Transcriptase Mutation
Croatian: Početna mutacija reverzne transkriptaze
English: Abacavir is metabolised primarily by the liver.
Croatian: Abakavir se metabolizira primarno u jetri.
English: ANTIMYCOBACTERIALS Rifampicin/Abacavir
Croatian: ANTIMIKOBAKTERICI rifampicin/abakavir
English: The observed values of the peak concentrations are 9 fold greater than the IC50 of abacavir of 0.08 µg/ml or 0.26 µM when abacavir is given at 600 mg twice daily.
Croatian: IC50 abakavira od 0,08 µg/ml ili 0,26 µM kad se abakavir daje u dozi od 600 mg dvaput na dan.
English: Animal studies with abacavir have shown toxicity to the developing embryo and foetus in rats, but not in rabbits.
Croatian: Ispitivanja abakavira na životinjama pokazala su toksičnost za razvoj embrija i fetusa u štakora, ali ne i u kunića.
English: Virologic Response at Week 48 ITT-Exposed Population < 50 copies/ml TLOVR
Croatian: Virološki odgovor u 48. tjednu ITT -Izložena populacija < 50 kopija/ml TLOVR ABC/3TC + EFV (N =192)
English: The mean EC50 against laboratory strains of HIV-2 (LAV2 and EHO) ranged from 1.57 to 7.5 µM for abacavir and from 0.16 to 0.51 µM for lamivudine.
Croatian: Srednje vrijednosti EC50 protiv laboratorijskih sojeva HIV-2 (LAV2 i EHO) kretale su se u rasponu od 1,57 do 7,5 µM za abakavir i od 0,16 do 0,51 µM za lamivudin.
English: Common: hypersensitivity
Croatian: Često: preosjetljivost
English: What Kivexa looks like and contents of the pack Kivexa film-coated tablets are engraved with ‘GS FC2' on one side.
Croatian: Kivexa filmom obložene tablete imaju na jednoj strani utisnutu oznaku ''GS FC2''.
English: The EC50 values of abacavir against HIV-1 Group M subtypes (A-G) ranged from 0.002 to 1.179 µM, against Group O from 0.022 to 1.21 µM, and against HIV-2 isolates, from 0.024 to 0.49 µM.
Croatian: Vrijednosti EC50 za abakavir protiv HIV-1 grupe M, podtipova (A-G) kretale su se od 0,002 do 1,179 µM, protiv grupe O od 0,022 do 1,21 µM, i protiv HIV-2 izolatu, od 0,024 do 0,49 µM.
English: Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Croatian: Studije u bolesnika s oštećenjem bubrega pokazuju da disfunkcija bubrega utječe na eliminaciju lamivudina.
English: Fever, lethargy, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Croatian: Razno vrućica, letargija, malaksalost, edem, limfadenopatija, hipotenzija, konjunktivitis, anafilaksija
English: Nausea, vomiting, diarrhoea, abdominal pain, mouth ulceration
Croatian: Probavni sustav mučnina, povraćanje, proljev, bol u abdomenu, ulceracija u ustima
English: Dyspnoea, cough, sore throat, adult respiratory distress syndrome, respiratory failure
Croatian: Dišni sustav dispneja, kašalj, grlobolja, sindrom respiratornog distresa u odraslih, zatajenje disanja
English: If you have stopped taking Kivexa
Croatian: Ako ste prestali uzimati lijek Kivexa
English: Pancreatitis has been reported, but a causal relationship to lamivudine and abacavir is uncertain.
Croatian: Zabilježen je pankreatitis, ali nije sigurna uzročna povezanost s liječenjem lamivudinom i abakavirom.
English: Abacavir and lamivudine are not significantly metabolised by cytochrome P450 enzymes (such as CYP 3A4, CYP 2C9 or CYP 2D6) nor do they inhibit or induce this enzyme system.
Croatian: 3A4, CYP 2C9 ili CYP 2D6) niti pokazuju utjecaj na inhibiciju ili indukciju tog sustava enzima.
English: Kivexa contains abacavir and lamivudine, therefore any interactions identified for these individually are relevant to Kivexa.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Budući da Kivexa sadrži abakavir i lamivudin, bilo koja interakcija koja je ustanovljena s ovim lijekovima pojedinačno relevantna je za lijek Kivexa.
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 manje od 2% primijenjene doze izlučuje se renalnim putem u nepromijenjenom obliku.
English: The concentration of drug necessary to effect viral replication by 50% (EC50) or 50% inhibitory concentration (IC50) varied according to virus and host cell type.
Croatian: Koncentracija lijeka potrebna za učinak na virusnu replikaciju za 50% (EC50) ili
English: Drug susceptibility scores were assigned for each patient's viral genotype utilising the ANRS 2009 HIV-1 genotypic drug resistance algorithm.
Croatian: ANRS 2009 HIV-1 algoritma za genotipsku rezistenciju lijekova.
English: Cross-resistance between abacavir or lamivudine and antiretrovirals from other classes e.g. PIs or NNRTIs is unlikely.
Croatian: Križna rezistencija između abakavira ili lamivudina i antiretrovirusnih lijekova iz drugih skupina (npr.
English: In toxicology studies abacavir was shown to increase liver weights in rats and monkeys.
Croatian: U toksikološkim ispitivanjima pokazalo se da abakavir povećava težinu jetre u štakora i majmuna.
English: The clinical status of the patient and the adverse reaction profile of Kivexa should be borne in mind when considering the patient's ability to drive or operate machinery.
Croatian: Kad se razmatra sposobnost bolesnika da vozi ili upravlja strojem, treba imati na umu njegov klinički status i profil nuspojava lijeka Kivexa.
English: Appropriate use of abacavir and lamivudine can be guided using these currently recommended resistance algorithms.
Croatian: Za pravilnu primjenu abakavira i lamivudina potrebno je slijediti važeće algoritme rezistencije.
English: Abacavir is primarily metabolised by the liver.
Croatian: Abakavir se primarno metabolizira u jetri.
English: Almost all HSR to abacavir include fever and/or rash.
Croatian: Gotovo sve reakcije preosjetljivosti na abakavir bit će praćene vrućicom i/ili osipom.
English: Do not take Kivexa Take special care with Kivexa
Croatian: Budite posebno oprezni s lijekom Kivexa
English: • if you have a kidney problem
Croatian: • ako imate tegoba s bubrezima
English: Abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine.
Croatian: Abakavir se primarno metabolizira putem jetre, a manje od 2% se izlučuje urinom u nepromijenjenom obliku.
English: Response by Baseline HIV-1 RNA ≥100,000 c/mL
Croatian: Odgovor na osnovu HIV-1 RNA ≥100 000 c/mL
English: The combination of lamivudine with cladribine is not-recommended (see section 4.5).
Croatian: Ne preporučuje se uzimanje lamivudina sa kladribinom (vidjeti dio 4.5).
English: Combination therapy such as Kivexa may cause other conditions to develop during HIV treatment.
Croatian: Ostale moguće nuspojave u kombiniranoj terapiji za HIV Kombinirana terapija kao što je Kivexa može uzrokovati druga stanja koja se mogu razviti za vrijeme liječenja HIV-a.
English: People may be more likely to get this condition:
Croatian: Stoga korisnici mogu razviti sljedeće stanje:
English: In a meta-analysis of five clinical trials where ABC was added to intensify therapy, of 166 subjects, 123 (74%) had M184V/I, 50 (30%) had T215Y/F, 45 (27%) had M41L, 30 (18%) had K70R and 25 (15%) had D67N.
Croatian: U meta analizi 5 kliničkih ispitivanja u kojima je abakavir dodan kako bi se pojačala terapija, od ukupnog broja od 166 bolesnika, 123 (74%) je imalo M184V/I, 50 (30%) je imalo
English: Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Croatian: Abakavir se ne smije primijeniti u bolesnika koji su nositelji alela HLA-B*5701.
English: An interim analysis from ACTG 5202 revealed that abacavir/lamivudine was associated with a statistically significantly higher risk of virological failure as compared to emtricitabine/tenofovir (defined as viral load >1000 copies/mL at or after 16 weeks and before 24 weeks or HIV-RNA level
Croatian: Privremena analiza iz ACTG 5202 studije otkrila je da je abakavir/lamivudin bio povezan sa statistički značajno višim rizikom od izostanka virološkog odgovora u usporedbi s emtricitabin/tenofovirom
English: Kivexa is not recommended for use in patients with a creatinine clearance < 50 ml/min as necessary dose adjustment cannot be made.
Croatian: Ne preporučuje se primjena lijeka Kivexa u bolesnika s klirensom kreatinina < 50 ml/min jer se ne može provesti potrebna prilagodba doze.
English: Single dose lamivudine oral solution 300 mg
Croatian: Jednokratna doza oralne otopine lamivudina od 300 mg lamivudin:
English: Therapy-experienced patients
Croatian: Prethodno liječeni bolesnici
English: Diagnosis of Abacavir Hypersensitivity Reaction
Croatian: Dijagnoza reakcije preosjetljivosti na abakavir
English: If you have stopped taking Kivexa because of a hypersensitivity reaction, you must NEVER AGAIN take Kivexa, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen).
Croatian: Ako ste prestali uzimati lijek Kivexa zbog reakcije preosjetljivosti, ne smijete VIŠE NIKADA uzimati lijek Kivexa ili bilo koji lijek koji sadrži abakavir (npr. Trizivir, Triumeq ili Ziagen).
English: Kivexa 600 mg/300 mg film-coated tablets abacavir/lamivudine
Croatian: Kivexa 600 mg/300 mg filmom obložene tablete abakavir/lamivudin
English: Delay in stopping treatment with Kivexa after the onset of hypersensitivity may result in a life-threatening reaction.
Croatian: Odgađanje prekida liječenja lijekom Kivexa nakon nastupa preosjetljivosti može uzrokovati trenutačnu i po život opasnu reakciju.
English: CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Kivexa if:
Croatian: ODMAH SE JAVITE SVOM LIJEČNIKU koji će Vam savjetovati trebate li prestati uzimati lijek Kivexa ako: 1) dobijete osip po koži ILI
English: About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have the HLAB*5701 gene developed a hypersensitivity reaction.
Croatian: Reakcija preosjetljivosti razvila se u približno 3 do 4 na svakih 100 bolesnika koji su se liječili abakavirom u kliničkim ispitivanjima, a nisu imali gen HLA-B*5701.
English: ANTI-INFECTIVE PRODUCTS Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Abacavir
Croatian: ANTIINFEKTIVNI LIJEKOVI trimetoprim/sulfametoksazol (kotrimoksazol)/abakavir
English: RETINOIDS Retinoid compounds (e.g. isotretinoin)/Abacavir
Croatian: spojevi retinoida (npr. isotretinoin) /abakavir
English: Elevated liver function tests, hepatitis, hepatic failure
Croatian: Jetra/gušterača povišene razine jetrenih enzima, hepatitis, zatajenje jetre
English: Phenotypic susceptibility analyses of clinical isolates from antiretroviral-naïve patients with HIV-1 Group M non-B subtypes in three studies have each reported that all viruses were fully susceptible to both abacavir and lamivudine; one study of 104 isolates that included subtypes A and A1 (n=26), C (n=1), D (n=66), and the circulating recombinant forms (CRFs) AD (n=9), CD (n=1), and a complex inter-subtype recombinant_cpx (n=1), a second study of 18 isolates including subtype G (n=14) and CRF_AG (n=4) from Nigeria, and a third study of six isolates (n=4 CRF_AG, n=1 A and n=1 undetermined) from Abidjan (Côte d'Ivoire).
Croatian: (n=26), C (n=1), D (n=66) i cirkulirajuće rekombinantne oblike (CRFa) AD (n=9), CD (n=1), i kompleksne rekombinantne_cpx između podtipova (n=1), drugo ispitivanje sa 18 izolata uključujući podtip G (n=14) i CRF_AG (n=4) iz Nigerije, i treće ispitivanje sa šest izolata (n=4 CRF_AG, n=1 A i n=1 neodređeno) iz Abidjana (Obala Bjelokosti).
English: Efficacy Outcome at Week 48 in CNA30021 by baseline HIV-1 RNA and CD4 Categories (ITTe TLOVR ART naïve subjects).
Croatian: Ishod djelotvornosti u 48 tjednu u ispitivanju oznake CNA30021 prema početnim HIV-1 RNA i
English: Talk to your doctor if any of these apply to you before using Kivexa.
Croatian: Obavijestite svog liječnika prije uzimanja lijeka Kivexa ako se bilo što od navedenog odnosi na Vas.
English: 30 tablets in opaque white (PVC/PVDCAluminium/Paper) child-resistant blister packs Multipacks containing 90 (3 packs of 30) tablets in opaque white (PVC/PVDC-Aluminium/Paper) child-resistant blister packs.
Croatian: Višestruko pakiranje sadrži 90 (3 pakiranja od 30) tableta u u neprozirnom bijelom (PVC/PVDCAl/papir) blister pakiranju sa sigurnosnom folijom za djecu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of abacavir (as sulfate) and 300 mg lamivudine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 600 mg abakavira (u obliku abakavirsulfata) i 300 mg lamivudina.
English: Response by Baseline HIV-1 RNA <100,000 c/mL
Croatian: Odgovor na osnovu HIV-1 RNA <100 000 c/mL
English: Very rare: lactic acidosis
Croatian: Vrlo rijetko: laktacidoza
English: For the CNA109586 (ASSERT) and CNA30021 studies in treatment-naïve patients, genotype data was obtained for only a subset of patients at screening or at baseline, as well as for those patients who met virologic failure criteria.
Croatian: 1 Glavne IAS-USA mutacije na abakavir ili lamivudin i mutacije povezane s višestrukom-NRTI rezistencijom U ispitivanjima CNA109586 (ASSERT) i CNA30021 koja su provedene na neliječenim bolesnicima, genotipski podaci dobiveni su samo kod podskupine bolesnika pri probiru ili pri početku ispitivanja kao i za one bolesnike koji su udovoljavali kriterijima izostanka virološkog odgovora.
English: The symptoms related to HSR worsen with continued therapy and can be life-threatening.
Croatian: Simptomi povezani s reakcijom preosjetljivosti pogoršavaju se s nastavkom terapije i mogu ugroziti život bolesnika.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2)
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: Other signs and symptoms that have been observed as part of abacavir HSR are described in detail in section 4.8 (Description of selected adverse reactions), including respiratory and gastrointestinal symptoms.
Croatian: Drugi znakovi i simptomi primijećeni kao dio reakcija preosjetljivosti na abakavir detaljno su opisani u dijelu 4.8
English: No conclusion can be drawn with regard to the teratogenic potential of abacavir because of this embryo-foetal toxicity.
Croatian: Iz tih podataka o embriofetalnoj toksičnosti ne mogu se izvući zaključci o teratogenom potencijalu abakavira.
English: Phenytoin/Abacavir
Croatian: fenitoin/abakavir
English: Kivexa is not recommended for use in patients with a creatinine clearance < 50 ml/min as necessary dose adjustment cannot be made (see section 5.2).
Croatian: Ne preporučuje se primjena lijeka Kivexa u bolesnika s klirensom kreatinina < 50 ml/min jer se ne može provesti potrebna prilagodba doze (vidjeti dio 5.2).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: - Triple nucleoside therapy: There have been reports of a high rate of virological failure, and of emergence of resistance at an early stage when abacavir and lamivudine were combined with tenofovir disoproxil fumarate as a once daily regimen.
Croatian: - Liječenje kombinacijom tri nukleozida: Pri kombiniranoj primjeni abakavira i lamivudina s tenofovir dizoproksilfumaratom jedanput na dan, zabilježena je visoka stopa izostanka virološkog odgovora te nastup rezistencije u ranoj fazi liječenja.
English: Kivexa is not recommended for use in patients with a creatinine clearance < 50 ml/min as necessary dose adjustment cannot be made (see section 4.2).
Croatian: Ne preporučuje se primjena lijeka Kivexa u bolesnika s klirensom kreatinina < 50 ml/min jer se ne može provesti potrebna prilagodba doze (vidjeti dio 4.2).
English: NAME OF THE MEDICINAL PRODUCT Kivexa 600 mg/300 mg film-coated tablets
Croatian: NAZIV LIJEKA Kivexa 600 mg/300 mg filmom obložene tablete
English: There was also no clinically significant food effect observed between administration of FDC in the fasted or fed state.
Croatian: Također nisu zapaženi klinički značajni učinci hrane na primjenu fiksne kombinacije natašte ili uz obrok.
English: : + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
Croatian: ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
English: Lamivudine is predominately cleared by renal excretion of unchanged lamivudine.
Croatian: Lamivudin se najvećim dijelom uklanja izlučivanjem putem bubrega u nepromijenjenom obliku.
English: Proportion of Patients in CAL30001 with <50 copies/mL at Week 48 by Genotypic Sensitivity Score in OBT and Number of Baseline Mutations
Croatian: Udio bolesnika u ispitivanju CAL30001 s <50 kopija/mL u 48. tjednu prema indeksu genotipske osjetljivosti u OBT i broju početnih mutacija
English: In study CAL30001, 182 treatment-experienced patients with virologic failure were randomised and received treatment with either Kivexa once daily or abacavir 300 mg twice daily plus lamivudine 300 mg once daily, both in combination with tenofovir and a PI or an NNRTI for 48 weeks.
Croatian: U ispitivanju CAL30001, 182 bolesnika koji pri prethodnom liječenju nisu imali virološki odgovor randomizirani su tako da su tijekom 48 tjedana dobivali ili lijek Kivexa jedanput na dan ili abakavir u dozi od 300 mg dvaput na dan uz lamivudin 300 mg jedanput na dan, u oba slučaja u kombinaciji s tenofovirom i nekim inhibitorom proteaze ili nekim nenukleozidnim inhibitorom reverzne transkriptaze.
English: The mean ratio of CSF/serum lamivudine concentrations 2-4 hours after oral administration was approximately 12%.
Croatian: Srednji omjer koncentracija lamivudina u likvoru i serumu 2-4 sata nakon peroralne primjene iznosi oko
English: These may affect up to 1 in 1000 people:
Croatian: Rijetke nuspojave Mogu se pojaviti u manje od 1 na 1000 osoba:
English: • numbness, tingly feelings in the skin (pins and needles)
Croatian: • utrnulost, osjećaj trnaca na koži (mravinjanje),
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Multipacks of 90 (3 packs of 30 film-coated tablets) - without blue boxOUTER CARTON BLISTER PACK 30 TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Višestruko pakiranje koje sadrži 90 (3 pakiranja svako sa po 30 tableta) (bez Plavog okvira) VANJSKA KUTIJA BLISTER PAKIRANJA
English: • if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir - (e.g. Trizivir, Triumeq or Ziagen), lamivudine or any of the other ingredients of this medicine (listed in Section 6) Carefully read all the information about hypersensitivity reactions in Section 4.
Croatian: Triumeq ili Ziagen), lamivudin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Rifampicin/Lamivudine
Croatian: rifampicin/lamivudin
English: If the doctor thinks they may have been related, you will be told never again to take Kivexa, or any other medicine containing abacavir (e.g.Trizivir,Triumeq or Ziagen).
Croatian: Ako liječnik misli da bi mogli biti povezani, reći će Vam da više nikad ne uzimate lijek Kivexa, ili bilo koji drugi lijek koji sadrži abakavir (npr. Trizivir, Triumeq ili Ziagen).
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.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: Farmakokinetika abakavira ispitivana je u bolesnika s blagim oštećenjem jetre (Child-Pugh vrijednosti 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: Cimetidine/Abacavir
Croatian: cimetidin/abakavir
English: GlaxoSmithKline (Cyprus) Ltd Τηλ: + 357 22 39 70 00 gskcyprus@gsk.com
Croatian: GlaxoSmithKline (Cyprus) Ltd Τηλ: + 357 22 39 70 00
English: Baseline CD4 category 201-350 101/143 (71%)
Croatian: Početna CD4 kategorija 50-100 21/40 (53%) Početna CD4 kategorija 101-200 57/85 (67%) Početna CD4 kategorija 201-350 101/143 (71%) Početna CD4 kategorija >350 71/109 (65%)
English: Number of Subjects Number of Virological Failures Number of OnTherapy Genotypes
Croatian: Broj bolesnika Broj izostanaka virološkog odgovora Broj genotipova tijekom liječenja 40 (100%)
English: Hypersensitivity reactions (see also section 4.8 )
Croatian: a ne zbog simptoma reakcija preosjetljivosti (vidjeti dio 4.8 “Opis odabranih nuspojava”).
English: • After stopping treatment with Kivexa for reasons of a suspected HSR, Kivexa or any other medicinal product containing abacavir (e.g. Ziagen, Trizivir, Triumeq) must never be reinitiated.
Croatian: • Nakon prekida liječenja lijekom Kivexa zbog suspektne reakcije preosjetljivosti, nikada se ne smije ponovno započeti liječenje lijekom Kivexa niti bilo kojim drugim lijekom koji sadrži abakavir (npr. Ziagen, Trizivir, Triumeq).
English: Elevated creatinine, renal failure
Croatian: Mokraćni sustav povišene razine kreatinina, zatajenje bubrega
English: V75I, F77L and F116Y, cause a high level of resistance to abacavir.
Croatian: insercijski kompleks na mjestu 69 ili mutacija Q151M, koja se obično nalazi u kombinaciji s A62V, V75I, F77L i F116Y, uzrokuju visoku razinu rezistencije na abakavir.
English: The clinical relevance of this finding has not been determined.
Croatian: Klinički značaj ovog nalaza nije određen.
English: Proportion of Patients in CNA30021with <50 cps/mL at Week 48 by Genotypic Sensitivity Score in OBT and Number of Baseline Mutations
Croatian: Udio bolesnika u ispitivanju CNA30021 koji su u 48. tjednu imali <50 kopija/ml prema indeksu genotipske osjetljivosti u OBT i broju početnih mutacija
English: These have been identified either from clinical studies or post marketing surveillance.
Croatian: Znakovi i simptomi te reakcije preosjetljivosti navedeni su u nastavku, a utvrđeni su ili u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet.
English: Proportions with HIV-1 RNA < 50 copies/ml (50% versus 47%) and < 400 copies/ml (54% versus 57%) at week 48 were also similar in each group (ITT population).
Croatian: kopija/ml (54% prema 57%) u 48 tjednu.
English: None M184V alone Any one NRTI mutation Any two NRTIassociated mutations 22
Croatian: Bilo koja pojedinačna mutacija NRTI Bilo koje dvije mutacije povezane s NRTI Bilo koje tri mutacije povezane s NRTI
English: Kivexa helps to control your condition.
Croatian: Ostanite u redovitom kontaktu sa svojim liječnikom Kivexa pomaže u kontroliranju Vaše bolesti.
English: The clinical relevance of these findings is unknown.
Croatian: Klinička značajnost ovih nalaza nije poznata.
English: Hypersensitivity case studies
Croatian: Prikaz slučaja preosjetljivosti
English: Common: headache
Croatian: • glavobolju
English: 1 Major IAS-USA defined mutations to Abacavir or Lamivudine and multi-NRTI resistance associated mutations
Croatian: Procjenjivao se i utjecaj glavnih mutacija definiranih prema IAS-USA na abakavir ili lamivudin, te mutacija povezanih s višestrukom-NRTI rezistencijom prema broju početnih mutacija tijekom odgovora.
English: Emtricitabine/Lamivudine
Croatian: emtricitabin/lamivudin
English: Some medicines interact with Kivexa These include:
Croatian: Neki lijekovi imaju interakciju s lijekom Kivexa
English: No studies on the effects on ability to drive and use machines have been performed.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedena ispitivanja o učincima abakavira i lamivudina na sposobnost upravljanja vozilima i rada sa strojevima.
English: Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea
Croatian: Često: mučnina, povraćanje, bol u abdomenu ili grčevi, proljev
English: NAME OF THE MEDICINAL PRODUCT Kivexa 600 mg/300 mg film-coated tablets abacavir/lamivudine
Croatian: NAZIV LIJEKA Kivexa 600 mg/300 mg tablete abakavir/lamivudin
English: • Clinical Description of abacavir HSR
Croatian: • Klinički opis reakcije preosjetljivosti na abakavir