FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Če ste zdravilo Kivexa prenehali jemati zaradi preobčutljivostne reakcije, zdravila Kivexa ali katerega koli drugega zdravila, ki vsebuje abakavir (npr. zdravilo Ziagen, Triumeq ali Trizivir) NE SMETE NIKOLI VEČ VZETI, saj lahko v nekaj urah pride do smrtno nevarnega znižanja krvnega tlaka ali smrti.
English: Lamivudine is predominately cleared by renal excretion of unchanged lamivudine.
Slovenian: Lamivudin se v glavnem izloča preko ledvic v nespremenjeni obliki.
English: Logistic regression modelling of the predictive value for genotype (adjusted for baseline plasma HIV-1RNA [vRNA], CD4+ cell count, number and duration of prior antiretroviral therapies) showed that the presence of 3 or more NRTI resistance-associated mutations was associated with reduced response at Week 4 (p=0.015) or 4 or more mutations at median Week 24 (p≤0.012).
Slovenian: število CD4+ celic, število in trajanje predhodnih protiretrovirusnih zdravljenj) je pokazal, da je bila prisotnost 3 ali več mutacij, povezanih z odpornostjo proti NRTI, povezana z zmanjšanjem odziva v 4. tednu (p = 0,015), prisotnost 4 ali več mutacij pa v povprečju v 24. tednu (p ≤ 0,012).
English: The special warnings and precautions relevant to abacavir and lamivudine are included in this section.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi V to poglavje so vključena posebna opozorila in previdnostni ukrepi, ki se nanašajo na abakavir in lamivudin.
English: Restarting abacavir following an abacavir HSR results in a prompt return of symptoms within hours.
Slovenian: Pri ponovni uporabi abakavirja, po pojavu HSR na abakavir, se simptomi pojavijo hitro, že v nekaj urah.
English: Myalgia, rarely myolysis, arthralgia, elevated creatine phosphokinase
Slovenian: Mišično-skeletni sistem mialgija, redkeje mioliza, artralgija, zvišane vrednosti kreatinfosfokinaze
English: Dyspnoea, cough, sore throat, adult respiratory distress syndrome, respiratory failure
Slovenian: Dihala dispneja, kašelj, vnetje žrela, respiratorni distresni sindrom pri odraslih, dihalna odpoved
English: These metabolites are excreted in the urine.
Slovenian: Ta presnovka se v glavnem izločata z urinom.
English: As well as the side effects listed below for Kivexa, other conditions can develop during combination therapy for HIV.
Slovenian: Poleg spodaj naštetih neželenih učinkov zdravila Kivexa se lahko med kombiniranim zdravljenjem okužbe s HIV pojavijo še druge spremembe.
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).
Slovenian: Podatkovna baza o varnosti odmerjanja enkrat dnevno pri pediatričnih bolnikih temelji na preskušanju ARROW (COL105677), v katerem je 669 pediatričnih preiskovancev, okuženih s HIV-1, starih od 12 mesecev do vključno 17 let, prejemalo abakavir in lamivudin bodisi enkrat ali dvakrat na dan (glejte poglavje 5.1).
English: Data from two studies, CAL30001 and ESS30008 demonstrated that Kivexa once daily has similar virological efficacy to abacavir 300 mg twice daily plus lamivudine 300 mg once daily or 150 mg twice daily in therapy-experienced patients.
Slovenian: Podatki dveh študij, CAL30001 in ESS30008, so pokazali, da je virološka učinkovitost zdravila Kivexa enkrat na dan pri že zdravljenih bolnikih podobna virološki učinkovitosti abakavirja 300 mg dvakrat na dan skupaj z lamivudinom 300 mg enkrat na dan ali 150 mg dvakrat na dan.
English: The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5'-carboxylic acid and 5'-glucuronide which account for about 66% of the administered dose.
Slovenian: Pri človeku se abakavir v glavnem presnavlja z alkoholno dehidrogenazo in glukuronidacijo, pri čemer nastane 5'-karboksilna kislina in 5'-glukuronid, ki predstavljata približno
English: Read the information ‘Other possible side effects of combination therapy for HIV' in
Slovenian: Preberite informacije v poglavju 4 "Drugi možni neželeni učinki kombiniranega zdravljenja okužbe s HIV" v tem navodilu.
English: Mutagenicity and carcinogenicity
Slovenian: Mutagenost in karcinogenost
English: Opadry Orange YS-1-13065-A containing: hypromellose titanium dioxide macrogol 400 polysorbate 80 sunset yellow FCF (E110)
Slovenian: Opadry Orange YS-1-13065-A, ki vsebuje: hipromelozo titanov dioksid makrogol 400 polisorbat 80
English: Proportion with HIV-1 RNA <50 copies/ml
Slovenian: Delež s HIV-1 RNA < 50 kopij/ml
English: The combination of abacavir and lamivudine as a once daily regimen is supported by a 48 weeks multi-centre, double-blind, controlled study (CNA30021) of 770 HIV-infected, therapy-naïve adults.
Slovenian: Režim odmerjanja kombinacije abakavir/lamivudin enkrat dnevno podpira multicentrična, dvojno slepa, nadzorovana študija, ki je pri 770 z virusom HIV okuženih, predhodno še nezdravljenih odraslih bolnikih trajala 48 tednov (CNA30021).
English: The fixed-dose combination tablet of abacavir/lamivudine (FDC) has been shown to be bioequivalent to lamivudine and abacavir administered separately.
Slovenian: Dokazano je bilo, da je tableta s kombinacijo abakavir/lamivudin v fiksnem odmerku bioekvivalentna ločenemu dajanju lamivudina in abakavirja.
English: ANTIRETROVIRAL MEDICINAL PRODUCTS Didanosine /Abacavir
Slovenian: PROTIRETROVIRUSNA ZDRAVILA didanozin/abakavir
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.
Slovenian: Za abakavir je prvi pokazal mediano vrednost EC50 0,912 µM (razpon: od 0,493 do 5,017 µM) in drugi 1,26 µM (razpon: od 0,72 do 1,91 µM), za lamivudin pa prvi mediano vrednost EC50 0,429 µM (razpon: od 0,200 do 2,007 µM) in drugi 2,38 µM (od 1,37 do 3,68 µM).
English: These findings should be considered for any child exposed in utero to nucleotide and nucleotide analogues, who presents with severe clinical findings of unknown etiology, particularly neurologic findings..
Slovenian: Te ugotovitve je treba upoštevati pri vseh otrokih, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom,
English: Symptoms may include:
Slovenian: Med simptomi so lahko:
English: Additionally, autoinduction of abacavir metabolism or induction of the metabolism of other medicinal products hepatically metabolised has not been observed in man.
Slovenian: Prav tako pri človeku niso opazili avtoindukcije presnove abakavirja ali indukcije presnove drugih zdravil, ki se presnavljajo v jetrih.
English: Abacavir is primarily metabolised by the liver with approximately 2% of the administered dose being renally excreted, as unchanged compound.
Slovenian: Abakavir se v glavnem presnavlja v jetrih, približno 2 % prejetega odmerka pa se v nespremenjeni obliki izloči preko ledvic.
English: Special patient populations
Slovenian: Posebne populacije bolnikov Jetrna okvara
English: Common: nausea, vomiting, diarrhoea
Slovenian: Pogosti: navzea, bruhanje, diareja
English: All Patients
Slovenian: Vsi preiskovanci
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.
Slovenian: • Po prenehanju zdravljenja z zdravilom Kivexa iz razloga suma na HSR, se zdravila Kivexa ali katerega koli drugega zdravila, ki vsebuje abakavir ( npr. Ziagen, Trizivir, Triumeq) nikoli ne sme ponovno uvesti.
English: Even patients who don't have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction)
Slovenian: Tudi pri bolnikih, ki nimajo gena HLA-B*5701, se lahko pojavi preobčutljivostna reakcija (huda alergijska reakcija).
English: • Kivexa must be stopped without delay, even in the absence of the HLA-B*5701 allele, if an HSR is suspected.
Slovenian: • Zdravljenje z zdravilom Kivexa je potrebno prekiniti brez odlašanja v primeru suma na HSR, tudi ob odsotnosti alela HLA-B*5701.
English: Kivexa is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and in children weighing at least 25 kg.
Slovenian: Kaj je zdravilo Kivexa in za kaj ga uporabljamo Zdravilo Kivexa se uporablja za zdravljenje okužbe z virusom HIV (virusom humane imunske pomanjkljivosti) pri odraslih, mladostnikih in otrocih, ki tehtajo vsaj 25 kg.
English: Following multiple-dose oral administration of lamivudine 300 mg once daily for seven days, the mean (CV) steady-state Cmax is 2.04 µg/ml (26%) and the mean (CV) AUC24 is 8.87 µg.h/ml (21%).
Slovenian: Po peroralnem sedemdnevnem dajanju lamivudina v odmerku 300 mg enkrat dnevno znaša srednja Cmax v stanju dinamičnega ravnovesja 2,04 µg/ml (26 %), srednja (CV) AUC24 pa 8,87 µg.h/ml
English: Kivexa should not be taken with any other medicinal products containing lamivudine (see section 4.4).
Slovenian: Zdravila Kivexa se ne sme jemati z nobenim drugim zdravilom, ki vsebuje lamivudin (glejte poglavje
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.
Slovenian: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Slovenian: Sindrom imunske reaktivacije Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
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.
Slovenian: Povprečne vrednosti EC50 proti laboratorijskim sevom HIV-2 (LAV2 in EHO) so segale od 1,57 do 7,5 µM za abakavir in od 0,16 do 0,51 µM za lamivudin.
English: LIST OF EXCIPIENTS Contains sunset yellow (E110), see leaflet for further information
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje sončno rumeno FCF (E110), za nadaljnje informacije glejte navodilo za uporabo.
English: In a study of 20 HIV-infected patients receiving abacavir 300 mg twice daily, with only one 300 mg dose taken prior to the 24 hour sampling period, the geometric mean terminal carbovir-TP intracellular half-life at steady-state was 20.6 hours, compared to the geometric mean abacavir plasma half-life in this study of 2.6 hours.
Slovenian: V študiji, kjer je 20 z virusom HIV okuženih bolnikov prejemalo abakavir v odmerku 300 mg dvakrat dnevno, pri čemer je bil pred obdobjem 24-urnega jemanja vzorcev dan le en 300 mg odmerek, je bil geometrični srednji terminalni znotrajcelični razpolovni čas karbovir-TP v stanju dinamičnega ravnovesja 20,6 ur.
English: High doses of trimethoprim/ sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis have not been studied and should be avoided
Slovenian: Pneumocystis jirovecii (PCP) in toksoplazmoze niso raziskani in se jim je treba izogibati.
English: Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Slovenian: Študije pri bolnikih z ledvično okvaro so pokazale, da ledvična disfunkcija vpliva na izločanje lamivudina.
English: Lamivudine: AUC ↓ 14%; 32%; 36%
Slovenian: Enkraten odmerek lamivudina 300 mg peroralne raztopine lamivudin: AUC ↓ 14%; 32%; 36%
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.
Slovenian: Na voljo so v pretisnih omotih, ki vsebujejo 30 tablet in pretisnih omotih po več enot, ki vsebujejo 90 (3x30) tablet.
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.
Slovenian: Srednja vrednost sistemskega očistka lamivudina je približno 0,32 l/h/kg, pri čemer glavni delež odpade na ledvični očistek
English: No conclusion can be drawn with regard to the teratogenic potential of abacavir because of this embryo-foetal toxicity.
Slovenian: Iz teh ugotovitev o embrio fetalni toksičnosti se zaključki o teratogenem potencialu abakavirja ne morejo podati.
English: The recommended dose of Kivexa for adults, adolescents and children weighing 25 kg or more is one tablet once a day.
Slovenian: Priporočeni odmerek zdravila Kivexa za odrasle, mladostnike in otroke, ki tehtajo 25 kg ali več,
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.
Slovenian: V navzkrižni študiji pri 60 zdravih prostovoljcih so bili znotrajcelični farmakokinetični parametri lamivudin-TP-ja pri režimu odmerjanja lamivudina 300 mg enkrat na dan podobni (AUC24,ss in Cmax24,ss) ali manjši (Ctrough - 24%) kot pri režimu odmerjanja lamivudina 150 mg dvakrat na dan. Ti podatki na splošno podpirajo uporabo lamivudina v odmerku 300 mg in abakavirja v odmerku 600 mg enkrat dnevno za zdravljenje bolnikov, okuženih z virusom HIV.
English: These may affect up to 1 in 10,000 people:
Slovenian: Pojavijo se lahko pri največ 1 od 10.000 bolnikov:
English: Within this population, 104 HIV-1 infected paediatric subjects weighing at least 25 kg received abacavir and lamivudine as
Slovenian: Znotraj te populacije so 104 s HIV-1 okuženi pediatrični preiskovanci, ki so tehtali vsaj 25 kg, prejemali abakavir in lamivudin v obliki zdravila Kivexa enkrat dnevno.
English: 1 Major IAS-USA (Dec 2009) defined mutations for Abacavir or Lamivudine
Slovenian: 1 Glavne mutacije na abakavir ali lamivudin po definiciji IAS-USA (Dec 2009) Pediatrična populacija
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.
Slovenian: 330 mg/kg/dan pri miših in 600 mg/kg/dan pri podganah.
English: In a meta-analysis of six clinical trials, TAMs were not selected by regimens containing abacavir without zidovudine (0/127), but were selected by regimens containing abacavir and the thymidine analogue zidovudine
Slovenian: V metaanalizi šestih kliničnih preskušanj pri režimu, ki je vseboval abakavir brez zidovudina (0/127), selekcije mutacij timidinskih analogov niso ugotovili, ugotovili pa so jo pri režimih, ki so vsebovali abakavir in timidinski analog zidovudin (22/86, 26%).
English: - Keep this leaflet.
Slovenian: “Povlecite tukaj.”
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Kivexa without your doctor's advice, as your hepatitis may come back)
Slovenian: • če ste kdaj imeli bolezen jeter, vključno s hepatitisom B ali C (če imate okužbo s hepatitisom B,
English: The subjects in the low viral load stratum remained blinded and on-study.
Slovenian: Bolniki v stratumu z majhnim virusnim bremenom so ostali slepljeni in v študiji.
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.
Slovenian: Vrednosti EC50 za abakavir proti podtipom HIV-1 skupine M (A-G) so segale od 0,002 do 1,179 µM, proti skupini O od 0,022 do 1,21 µM in proti izolatom HIV-2 od 0,024 do 0,49 µM.
English: In toxicology studies abacavir was shown to increase liver weights in rats and monkeys.
Slovenian: Toksikološke študije so pokazale, da je abakavir povečal maso jeter pri podganah in opicah.
English: CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Kivexa if:
Slovenian: NEMUDOMA SE POSVETUJTE S SVOJIM ZDRAVNIKOM, ali morate morda prenehati z jemanjem zdravila Kivexa, če se pri vas pojavi:
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: Interakcije z drugimi zdravili
English: CNA109586 (ASSERT study), a multi-centre, open label, randomised study of abacavir/lamivudine (ABC/3TC, 600mg/300mg) and tenofovir/emtricitabine (TDF/FTC, 300mg/200mg), each given once daily with efavirenz (EFV, 600mg) in ART naïve, HLA-B*5701 negative, HIV-1 infected adults.The virologic results are summarised in the table below:
Slovenian: Študija CNA109586 (študija ASSERT), je bila multicentrična, odprta, randomizirana študija abakavirja/lamivudina (ABC/3TC, 600 mg/300 mg) in tenofovirja/emtricitabina (TDF/FTC, 300 mg/200 mg), vsake od obeh shem uporabljene enkrat na dan z efavirenzem (EFV, 600 mg) pri HLA-B*5701 negativnih bolnikih okuženih s HIV-1, ki še niso prejemali antiretrovirusnega zdravljenja (ART).
English: • hypersensitivity reaction
Slovenian: • preobčutljivostna reakcija;
English: Abacavir is rapidly and well absorbed from oral formulations when administered to children.
Slovenian: Pri otrocih se abakavir hitro in dobro absorbira iz peroralnih farmacevtskih oblik.
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.
Slovenian: Aktivno ledvično izločanje lamivudina v urinu posredujejo organski kationski prenašalci; sočasna uporaba lamivudina z zaviralci teh prenašalcev ali z nefrotoksičnimi zdravili lahko poveča izpostavljenost lamivudinu.
English: Before initiating abacavir therapy, clinicians should screen for HLA-B*5701 .
Slovenian: Pred uvedbo zdravljenja z abakavirjem morajo zdravniki izvesti presejanje za HLA-B*5701.
English: Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years.
Slovenian: Pri miših in podganah so po dveletnem dajanju abakavirja opazili blago degeneracijo miokarda.
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).
Slovenian: tednih ugotovljen tudi podoben odstotek HIV-1 RNA < 50 kopij/ml (50 % versus 47 %) in < 400
English: Results at 48 weeks indicated that the Kivexa group was associated with a similar virologic outcome (non-inferior) compared to the abacavir plus lamivudine group, based on proportions of subjects with HIV-1 RNA < 50 copies/ml (90% and 85% respectively, 95% CI -2.7, 13.5).
Slovenian: Rezultati po 48. tednih so pokazali, da je bil v skupini, ki je prejemala zdravilo Kivexa, virusni odziv podoben (enakovreden) odzivu v skupini, ki je prejemala abakavir in lamivudin (izhajajoč iz odstotka oseb s HIV-1 RNA < 50 kopij/ml (90 % oziroma 85 %; interval zaupanja 95 %; -2,7; 13,5)).
English: • fever (high temperature) and skin rash.
Slovenian: • povišana telesna temperatura in izpuščaj na koži.
English: Nausea, vomiting, diarrhoea, abdominal pain, mouth ulceration
Slovenian: Prebavila navzea, bruhanje, diareja, abdominalne bolečine, razjede v ustih
English: ANTI-INFECTIVE PRODUCTS Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Abacavir
Slovenian: PROTIMIKROBNA ZDRAVILA trimetoprim/sulfametoksazol (kotrimoksazol)/abakavir
English: Important information about some of the other ingredients of Kivexa tablets Kivexa contains a colouring called sunset yellow (E110), this may cause allergic reactions in some people.
Slovenian: Zdravilo Kivexa vsebuje barvilo sončno rumeno FCF (E110), ki lahko pri nekaterih osebah povzroči alergijske reakcije.
English: Very rare: lactic acidosis
Slovenian: Zelo redki:laktacidoza
English: Abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine.
Slovenian: Abakavir se v prvi vrsti presnavlja v jetrih, pri čemer se ga 2 % izloči v nespremenjeni obliki z urinom.
English: Other symptoms include:
Slovenian: Med drugimi simptomi so še:
English: Phenotypic resistance to abacavir requires M184V with at least one other abacavir-selected mutation, or M184V with multiple TAMs.
Slovenian: Za fenotipsko odpornost proti abakavirju je potrebna mutacija M184V in še vsaj ena z abakavirjem povzročena mutacija ali mutacija M184V z večkratnimi mutacijami timidinskih analogov.
English: • if you have a kidney problem
Slovenian: • če imate težave z ledvicami.
English: Kivexa contains abacavir and lamivudine, therefore any interactions identified for these individually are relevant to Kivexa.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravilo Kivexa vsebuje abakavir in lamivudin, zato je katera koli interakcija, povezana s posamezno zdravilno učinkovino, relevantna tudi za zdravilo Kivexa.
English: Risk of virological failure
Slovenian: Tveganje za virusni neodziv
English: Other common symptoms are:
Slovenian: Drugi pogosti simptomi so:
English: • difficulty breathing In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders).
Slovenian: V redkih primerih se lahko zgodi, da okrepljeni imunski sistem napade zdrava telesna tkiva (avtoimunske bolezni).
English: These may affect up to 1 in 1000 people:
Slovenian: Pojavijo se pri pri največ 1 od 1.000 bolnikov:
English: Uncommon: Transient rises in liver enzymes (AST, ALT), Rare: Hepatitis
Slovenian: Občasni: prehodno povečanje aktivnosti jetrnih encimov (AST, ALT)
English: Baseline Reverse Transcriptase Mutation
Slovenian: Mutacija reverzne transkriptaze
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).
Slovenian: Zdravila Kivexa ni priporočljivo uporabljati pri bolnikih s kreatininskim očistkom < 50 ml/min, saj obvezno prilagajanje odmerka ni možno (glejte poglavje 4.2).
English: The mean ratio of CSF/serum lamivudine concentrations 2-4 hours after oral administration was approximately 12%.
Slovenian: Od 2 do 4 ure po peroralnem dajanju je bilo srednje razmerje koncentracij lamivudina CST/serum približno
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.
Slovenian: Abakavir in lamivudin se s pomočjo encimov iz skupine citokrom P450 (npr. CYP 3A4, CYP 2C9 ali
English: Group O isolates from antiviral naïve patients tested for lamivudine activity were highly sensitive.
Slovenian: testirani za aktivnost lamivudina so bili zelo občutljivi.
English: Kivexa contains two active ingredients that are used to treat HIV infection: abacavir and lamivudine.
Slovenian: Zdravilo Kivexa vsebuje dve zdravilni učinkovini: abakavir in lamivudin.
English: NAME OF THE MEDICINAL PRODUCT Kivexa 600 mg/300 mg film-coated tablets
Slovenian: IME ZDRAVILA Kivexa 600 mg/300 mg filmsko obložene tablete
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.
Slovenian: vnetje očesne veznice (konjunktivitis), razjede v ustih, nizek krvni tlak, mravljinčenje ali omrtvelost rok ali nog.
English: Tablet Coating
Slovenian: Obloga tablete
English: Methadone dosage adjustment unlikely in majority of patients; occasionally methadone re-titration may be required.
Slovenian: Pri večini bolnikov prilagoditev odmerka metadona ni verjetna;