FrancophonIA/ELRC3.0 huggingface dataset:
English: The Kivexa pack includes an Alert Card, to remind you and medical staff about hypersensitivity reactions.
Slovenian: Škatlica zdravila Kivexa vsebuje opozorilno kartico, ki opozori vas in zdravniško osebje na preobčutljivostne reakcije.
English: The tablet coating contains Opadry Orange YS-1-13065-A containing hypromellose, titanium dioxide, macrogol 400, polysorbate 80 and sunset yellow FCF (E110).
Slovenian: Obloga tablete vsebuje Opadry Orange YS-1-13065-A, ki vsebuje hipromelozo, titanov dioksid, makrogol 400, polisorbat 80 in oranžno FCF (E110).
English: Pancreatitis has been reported, but a causal relationship to lamivudine and abacavir is uncertain.
Slovenian: Poročali so o primerih pankreatitisa, vendar pa je vzročna povezava z lamivudinom in abakavirjem negotova.
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.
Slovenian: Presejanje HLA-B*5701 glede tveganja za preobčutljivost na ABC ne sme pri osebah, ki prejemajo ABC, nikdar biti nadomestilo za ustrezno klinično pozornost in vodenje bolnika.
English: The carcinogenic potential of a combination of abacavir and lamivudine has not been tested.
Slovenian: Karcinogeni potencial kombinacije abakavir in lamivudin ni bil raziskovan.
English: Data obtained in patients with moderate to severe hepatic impairment show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Slovenian: Podatki, pridobljeni pri bolnikih z zmerno do hudo jetrno okvaro kažejo, da jetrna disfunkcija na farmakokinetične lastnosti lamivudina znatneje ne vpliva.
English: Patients were stratified at screening based on plasma HIV-1 RNA levels < 100,000 and ≥ 100,000 copies/mL.
Slovenian: Bolniki so bili na presejanju stratificirani glede na plazemsko koncentracijo HIV-1 RNA < 100.000 in ≥ 100.000 kopij/ml.
English: The symptoms related to HSR worsen with continued therapy and can be life-threatening.
Slovenian: Simptomi, ki so pogojeni s HSR, se z nadaljevanjem zdravljenja slabšajo in lahko postanejo življenjsko nevarni.
English: Elimination of abacavir is via hepatic metabolism with subsequent excretion of metabolites primarily in the urine.
Slovenian: Izločanje abakavirja poteka preko presnove v jetrih, presnovki pa se nato pretežno izločijo z urinom.
English: Common: hypersensitivity
Slovenian: Pogosti: preobčutljivost
English: Abacavir and lamivudine triphosphates show significantly less affinity for host cell DNA polymerases.
Slovenian: Abakavir in lamivudin trifosfat imata občutno manjšo afiniteto do DNA polimeraz gostiteljske celice.
English: Combivir is a fixed dose combination of lamivudine and zidovudine 2.
Slovenian: Combivir je kombinacija lamivudina in zidovudina v fiksnem odmerku.
English: These findings included decreased foetal body weight, foetal oedema, and an increase in skeletal variations/malformations, early intra-uterine deaths and still births.
Slovenian: Med drugim so pri njih ugotovili zmanjšanje teže fetusov, edem fetusov, porast skeletnih sprememb/malformacij, zgodnje intrauterine pogine in mrtvorodnost.
English: HIV-1 resistance to lamivudine involves the development of a M184I or, more commonly, M184V amino acid change close to the active site of the viral RT.
Slovenian: Odpornost virusa HIV-1 na lamivudin vključuje nastanek M184I ali pogosteje M184V aminokislinske spremembe blizu aktivnega mesta virusne RT.
English: The results of an in vivo rat micronucleus test with abacavir and lamivudine in combination were negative.
Slovenian: Rezultati mikronukleus testa, izvedenega in vivo na podganah s kombinacijo abakavirja in lamivudina so bili negativni.
English: • tiredness, lack of energy
Slovenian: • izguba teka; • utrujenost, pomanjkanje energije;
English: INFORMATION IN BRAILLE kivexa
Slovenian: PODATKI V BRAILLOVI PISAVI kivexa
English: 1 Major IAS-USA defined mutations to Abacavir or Lamivudine and multi-NRTI resistance associated mutations
Slovenian: 1 Po definiciji IAS-USA glavne mutacije na abakavir ali lamivudin in z odpornostjo proti več NRTI povezane mutacije
English: A fertility study in rats has shown that abacavir and lamivudine had no effect on male or female fertility.
Slovenian: Študija plodnosti pri podganah je pokazala, da abakavir in lamivudin ne vplivata na plodnost samcev ali samic.
English: If Kivexa is discontinued in patients co-infected with HBV, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis (see the Summary of Product Characteristics for products containing lamivudine that are indicated for the treatment of HBV).
Slovenian: Če se pri bolnikih, ki so sočasno okuženi s HBV, zdravilo Kivexa ukine, je potrebno periodično spremljati tako teste jetrne funkcije kot označevalce replikacije HBV, saj lahko ukinitev lamivudina vodi v akutno poslabšanje hepatitisa (glejte povzetek glavnih značilnosti zdravila pri zdravilih, ki vsebujejo lamivudin in so indicirana za zdravljenje HBV).
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).
Slovenian: Opisan je bil tudi pojav avtoimunskih bolezni (npr. pojav Gravesove bolezni in avtoimunskega hepatitisa), toda opisani čas do začetka je bolj spremenljiv in ti dogodki se lahko pojavijo veliko mesecev po uvedbi zdravljenja (glejte poglavje 4.4).
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.
Slovenian: Pediatrične farmakokinetične študije so pokazale, da odmerjanje enkrat na dan zagotavlja ekvivalentno AUC24 kot odmerjanje enakega celotnega dnevnega odmerka dvakrat na dan tako za peroralno raztopino kot tablete.
English: However, some patients with a suspected ABC hypersensitivity reaction may not have the HLA-B*5701 allele.
Slovenian: Toda nekateri bolniki s sumom na preobčutljivostno reakcijo na ABC so lahko brez alela HLA-B*5701.
English: No antagonistic effects in vitro were seen with lamivudine and other antiretrovirals (tested agents:didanosine, nevirapine and zidovudine).
Slovenian: Antagonističnih učinkov z lamivudinom in drugimi protiretrovirusnimi učinkovinami (preskušane učinkovine: didanozin, nevirapin in zidovudin) niso zaznali In vitro.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack containing 90 (3 packs of 30) film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Pakiranje po več enot vsebuje 90 (3 pakiranja po 30) filmsko obloženih tablet.
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.
Slovenian: V metaanalizi petih kliničnih preskušanj, v katerih je bil abakavir dodan 166 osebam zaradi stopnjevanja zdravljenja, je 123 oseb (74 %) imelo M184V/I, 50 oseb (30 %) T215Y/F, 45 oseb (27 %) M41L, 30 oseb (18 %) K70R in 25 oseb (15 %) D67N.
English: Carcinogenicity studies with orally administered abacavir in mice and rats showed an increase in the incidence of malignant and non-malignant tumours.
Slovenian: Študije karcinogenosti peroralno danega abakavirja pri miših in podganah so pokazale večjo pogostnost pojava malignih in nemalignih tumorjev.
English: The adverse reactions reported for Kivexa were consistent with the known safety profiles of abacavir and lamivudine when given as separate medicinal products.
Slovenian: Neželeni učinki, o katerih so poročali za zdravilo Kivexa, se skladajo z znanim varnostnim profilom abakavirja oziroma lamivudina, če se ju daje v obliki samostojnih zdravil.
English: • In order to avoid restarting abacavir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Kivexa tablets
Slovenian: • Da bi preprečili ponovno uporabo abakavirja, je treba bolnikom, ki so imeli sum na HSR,
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.
Slovenian: Pri bolnicah, ki so hkrati okužene s hepatitisom in prejemajo zdravilo, ki vsebuje lamivudin, npr. zdravilo Kivexa, ter zanosijo, je treba upoštevati možnost ponovitve hepatitisa po prenehanju uporabe lamivudina.
English: In pregnant women treated with abacavir, more than 800 outcomes after first trimester exposure and more than 1000 outcomes after second and third trimester exposure indicate no malformative and foetal/neonatal effect.
Slovenian: Pri nosečnicah, ki so prejemale abakavir, podatki iz več kot 800 izidov po izpostavljenosti v prvem trimesečju in več kot 1000 izidov po izpostavljenosti v drugem in tretjem trimesečju, ne kažejo na malformacijske učinke abakavirja ali njegovih učinkov na plod ali novorojenčka.
English: Kivexa contains abacavir (which is also an active substance in medicines such as Trizivir, Triumeq and Ziagen).
Slovenian: Zdravilo Kivexa vsebuje abakavir (ki je tudi zdravilna učinkovina zdravil Trizivir, Triumeq in
English: These belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Slovenian: Spadata v skupino protiretrovirusnih zdravil, ki jih imenujemo zaviralci nukleozidne reverzne transkriptaze (ZNRT).
English: The safety and efficacy of Kivexa has not been established in patients with significant underlying liver disorders.
Slovenian: Varnosti in učinkovitosti uporabe zdravila Kivexa pri bolnikih z znatnimi osnovnimi motnjami v delovanju jeter niso dokazali.
English: How to take Kivexa
Slovenian: Kako jemati zdravilo Kivexa
English: Baseline CD4 category <50
Slovenian: Izhodiščna kategorija CD4
English: Phenotypic cross-resistance to other NRTIs with M184V or M184I mutation alone is limited.
Slovenian: Fenotipska navzkrižna odpornost proti drugim NRTI je v prisotnosti samo M184V ali samo M184I mutacije omejena.
English: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account.
Slovenian: Kot splošno navodilo velja, da je treba upoštevati podatke na živalih, kot tudi izkušnje pri nosečnicah, kadar se odločamo o uporabi protiretrovirusnih učinkovin za zdravljenje okužbe z virusom HIV pri nosečnicah in posledično za zmanjšanje tveganja vertikalnega prenosa na novorojenčka.
English: • Kivexa should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavircontaining regimen.
Slovenian: • Zdravila Kivexa se nikdar ne sme uvesti bolnikom s pozitivnim HLA-B*5701 statusom; prav tako se ga ne sme uvesti bolnikom z negativnim HLA-B*5701 statusom, ki so imeli v preteklosti med uporabo sheme z abakavirjem sum na HSR na abakavir (npr. Ziagen, Trizivir,
English: The median or mean EC50 values for lamivudine against laboratory strains of HIV-1 ranged from 0.007 to 2.3 µM.
Slovenian: Mediane ali povprečne vrednosti EC50 za lamivudin proti laboratorijskim sevom HIV-1 so segale od 0,007 to 2,3 µM.
English: Elevated creatinine, renal failure
Slovenian: Sečila zvišane vrednosti kreatinina, odpoved ledvic
English: None M184V alone Any one NRTI mutation Any two NRTIassociated mutations 22
Slovenian: Brez Samo M184V 75 Katerakoli ena mutacija NRTI 82
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Slovenian: Bolniki sočasno okuženi s kroničnim virusom hepatitisa B ali C Pri bolnikih s kroničnim hepatitisom B ali C, ki se zdravijo s kombiniranim protiretrovirusnim zdravljenjem, obstaja večje tveganje za resne in potencialno smrtne neželene učinke, povezane z jetri.
English: • Restarting abacavir containing products following a suspected abacavir HSR can result in a prompt return of symptoms within hours.
Slovenian: • Ponovna uvedba zdravil z abakavirjem po sumu na HSR na abakavir lahko povzroči takojšnjo ponovitev simptomov v nekaj urah.
English: ACTG 5202 study was a, multi-centre, comparative, randomised study of double-blind abacavir/lamivudine or emtricitabine/tenofovir in combination with open-label efavirenz or atazanavir/ritonavir in treatment-naïve HIV-1 infected patients.
Slovenian: Študija ACTG 5202 je bila multicentrična, primerjalna, randomizirana študija z dvojno slepo uporabo abakavirja/lamivudina ali emtricitabina/tenofovirja v kombinaciji odprte uporabe efavirenza ali atazanavirja/ritonavirja pri bolnikih, okuženih s HIV-1, ki še niso prejemali zdravljenja.
English: No studies on the effects on ability to drive and use machines have been performed.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
English: In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY
Slovenian: V primeru kakršnih koli simptomov, ki bi lahko bili povezani s preobčutljivostno reakcijo, se NEMUDOMA obrnite na svojega zdravnika.
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.
Slovenian: Preobčutljivostne reakcije (glejte tudi poglavje 4.8) Abakavir je povezan s tveganjem za preobčutljivostne reakcije (HSR) (glejte poglavje 4.8), za katere sta značilna povišana telesna temperatura in/ali izpuščaj, skupaj z drugimi simptomi, ki nakazujejo prizadetost več organov.
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.
Slovenian: Pri 669 preiskovancih, randomiziranih v tej študiji, (starih od 12 mesecev do vključno 17 let) je bilo dokazano, da je skupina z odmerjanjem abakavir/lamivudin enkrat na dan neinferiorna skupini z odmerjanjem dvakrat na dan glede na vnaprej opredeljeno mejo neinferiornosti -12 %, kar zadeva primarni opazovani dogodek < 80 kopij/ml v 48. tednu kot tudi v 96. tednu (sekundarni opazovani dogodek) ter vse druge testirane prage (< 200 kopij/ml, < 400 kopij/ml, < 1000 kopij/ml), ki so bili vsi znotraj omenjene meje neinferiornosti.
English: Both abacavir and lamivudine are metabolised sequentially by intracellular kinases to the respective 5'-triphosphate (TP) which are the active moieties.
Slovenian: Oba, tako abakavir kot lamivudin, se dosledno presnavljata z znotrajceličnimi kinazami v ustrezen 5'-trifosfat (TP), ki je aktivna oblika.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Detach enclosed Alert Card, it contains important safety information WARNING!
Slovenian: Odtrgajte priloženo opozorilno kartico, ki vsebuje pomembne informacije o varnosti.
English: Almost all patients developing hypersensitivity reactions will have fever and/or rash (usually maculopapular or urticarial) as part of the syndrome, however reactions have occurred without rash or fever.
Slovenian: Pri skoraj vseh bolnikih s preobčutljivostnimi reakcijami se kot del sindroma pojavi povišana telesna temperatura in/ali izpuščaj (običajno makulopapulozen ali urtikarijski), vendar pa so se preobčutljivostne reakcije pojavile tudi brez izpuščaja ali povišane telesne temperature.
English: Observational studies have shown an association between myocardial infarction and the use of abacavir.
Slovenian: Opazovalne študije so pokazale povezavo med miokardnim infarktom in jemanjem abakavirja.
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.
Slovenian: Diagnoza preobčutljivostne reakcije na abakavir Glavni simptomi, povezani s preobčutljivostnimi reakcijami na ABC so povišana telesna temperatura (~80 %), izpuščaj (~70 %), gastrointestinalni simptomi (> 50 %), npr. navzea, bolečine v trebuhu, bruhanje in driska, splošno slabo počutje, utrujenost in glavobol (~50 %) in drugi simptomi
English: Studies in animals showed that neither abacavir nor lamivudine had any effect on fertility (see section
Slovenian: V študijah na živalih niso ne za abakavir, niti za lamivudin ugotovili, da bi kakorkoli vplivala na plodnost (glejte poglavje 5.3).
English: Do not take Kivexa:
Slovenian: Ne uporabljajte zdravila Kivexa:
English: The risk for abacavir HSR to occur is high for patients who test positive for the HLA-B*5701 allele.
Slovenian: Tveganje za pojav HSR na abakavir je visoko pri bolnikih, ki so imeli pozitiven test za alel HLAB*5701.
English: Elevated liver function tests, hepatitis, hepatic failure
Slovenian: Jetra/pankreas zvišane vrednosti testov jetrne funkcije, hepatitis, jetrna odpoved
English: Similar clinical success (point estimate for treatment difference: -1.7, 95% CI -8.4, 4.9) was observed for both regimens.
Slovenian: Pri obeh režimih zdravljenja je bil opažen podoben (enakovreden) klinični uspeh (ocenjena razlika v razliki zdravljenja: -1,7; 95 % interval zaupanja; -8,4; 4,9).
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.
Slovenian: V kliničnem preskušanju se je približno pri 3 do 4 od 100 bolnikov, ki so prejemali abakavir in niso imeli gena HLA-B*5701, pojavila preobčutljivostna reakcija (huda alergijska reakcija).
English: It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV'.
Slovenian: Pomembno je, da preberete odlomek pod naslovom "Drugi možni neželeni učinki kombiniranega zdravljenja okužbe s HIV" v nadaljevanju tega poglavja.
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.
Slovenian: Zaradi opaženih razlik v učinkovitosti je Odbor za nadzor podatkov o varnosti priporočil, da je potrebno razmisliti o spremembi terapevtskega režima pri vseh bolnikih z velikim virusnim bremenom v stratum.
English: The results are presented below:
Slovenian: Rezultati so prikazani spodaj:
English: This recurrence of the HSR is usually more severe than on initial presentation, and may include lifethreatening hypotension and death.
Slovenian: Pri takšni ponovitvi je bila HSR običajno hujša kot pri prvem pojavu in je lahko vključevala življenjsko nevarno hipotenzijo in smrt.
English: Kivexa contains the azo colouring agent sunset yellow, which may cause allergic reactions.
Slovenian: Zdravilo Kivexa vsebuje azo barvilo sončno rumeno FCF, ki lahko povzroči alergijsko reakcijo.
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.
Slovenian: • če ste alergični na abakavir (ali katerokoli drugo zdravilo, ki vsebuje abakavir - npr. zdravilo Trizivir, Triumeq ali Ziagen), lamivudin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6);
English: Baseline HIV-1 samples from therapy-naive subjects with no amino acid substitutions associated with resistance have been evaluated using either the multi-cycle Virco Antivirogram™ assay (n=92 from COL40263) or the the single cycle Monogram Biosciences PhenoSense™ assay (n=138 from ESS30009).
Slovenian: Izhodiščni vzorci HIV-1 še nezdravljenih oseb brez aminokislinskih zamenjav, povezanih z odpornostjo, so bili ocenjeni ali z multicikličnim preizkusom Virco Antivirogram™ (n = 92 iz COL40263) ali monocikličnim preizkusom Monogram Biosciences PhenoSense™ (n = 138 iz
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.
Slovenian: V okviru imunske reaktivacije je bil opisan tudi pojav avtoimunskih bolezni (npr. pojav Gravesove bolezni in avtoimunskega hepatitisa), toda opisani čas do začetka je bolj spremenljiv in ti dogodki se lahko pojavijo veliko mesecev po uvedbi zdravljenja.
English: • inflammation of the pancreas (pancreatitis)
Slovenian: • vnetje trebušne slinavke (pankreatitis);
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Kivexa.
Slovenian: Zdravniku ali farmacevtu morate vedno povedati, če med zdravljenjem z zdravilom Kivexa začnete prejemati kakšno novo zdravilo.
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.
Slovenian: HIV v številnih vrstah celic, vključno s transformiranimi linijami celic T, iz monocitov/makrofagov nastalimi linijami ter v primarnih kulturah aktiviranimi limfociti iz periferne krvi in monociti/makrofagi.
English: Cross-resistance between abacavir or lamivudine and antiretrovirals from other classes e.g. PIs or NNRTIs is unlikely.
Slovenian: Navzkrižna odpornost med abakavirjem ali lamivudinom in protiretrovirusnimi zdravili iz drugih skupin, npr. zaviralci proteaz (PI) ali nenukleozidni zaviralci reverzne transkriptaze (NNRTI), je malo verjetna.
English: No firm conclusion could be drawn due to the limited data derived from this study.
Slovenian: Zaradi skopih podatkov, ki izhajajo iz te študije, pa zanesljivih zaključkov ne moremo podati.
English: The mean EC50 for abacavir against laboratory strains of HIV-1IIIB and HIV-1HXB2 ranged from 1.4 to 5.8 µM.
Slovenian: Povprečna EC50 za abakavir proti laboratorijskim sevom HIV-1IIIB in HIV-1HXB2 je segala od 1,4 do 5,8 µM.
English: The signs and symptoms of this HSR are listed below.
Slovenian: Znaki in simptomi povezani s HSR so navedeni spodaj.
English: ABC Hypersensitivity (including risk of reduced clinical vigilance for ABC HSR following HLA-B*5701 screening).
Slovenian: Preobčutljivost na ABC (vključno s tveganjem za zmanjšano klinično pozornost na preobčutljivostne reakcije na ABC po presejanju HLA-B*5701).
English: Symptoms related to this HSR worsen with continued therapy and can be life- threatening and in rare instance, have been fatal.
Slovenian: Simptomi, povezani s HSR, se z nadaljevanjem zdravljenja slabšajo in so lahko življenjsko nevarni in v redkih primerih celo smrtni.
English: The partial patient subset of data available for CNA30021 is tabulated below,
Slovenian: Podatki delne podskupine bolnikov, ki so na voljo za študijo CNA30021, so prikazani v spodnji preglednici, vendar jih je treba tolmačiti previdno.