FrancophonIA/ELRC3.0 huggingface dataset:
English: If you cannot swallow the tablet(s), you may crush and combine them with a small amount of food or drink, and take all the dose immediately.
Slovenian: Če tablet(e) ne morete zaužiti, jih/jo lahko zdrobite, zmešate z majhno količino hrane ali pijače in vzamete celoten odmerek naenkrat.
English: • Ziagen 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 abacavir-containing regimen.
Slovenian: • Zdravila Ziagen 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. Kivexa, Trizivir, Triumeq).
English: At week 48 the proportion of subjects with HIV RNA <50 copies/ml were 63%, 80% and 86% for the ZDV/3TC/ABC, ZDV/3TC/EFV and ZDV/3TC/ABC/EFV arms, respectively.
Slovenian: V 48. tednu je HIV RNA < 50 kopij/ml imelo 63 % oseb, ki so prejemale ZDV/3TC/ABC, 80 % oseb, ki so prejemale ZDV/3TC/EFV in 86 % oseb, ki so prejemale
English: In the as treated (AT) analysis the difference between both treatment arms was more noticeable (88% of patients in the abacavir group, compared to 95% of patients in the zidovudine group (point estimate for treatment difference: -6.8, 95% CI11.8; -1.7).
Slovenian: V analizi vseh bolnikov, ki so končali zdravljenje (AT - »as treated«) je bila razlika med obema režimoma zdravljenja še bolj opazna (88 % bolnikov, ki so prejemali abakavir in 95 % bolnikov, ki so prejemali zidovudin (ocenjena vrednost v razliki zdravljenja: -6,8; 95 % interval zaupanja -11,8; -1,7)).
English: Since Ziagen contains abacavir some patients taking Ziagen may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if treatment with Ziagen is continued.
Slovenian: Ker zdravilo Ziagen vsebuje abakavir, se lahko pri bolnikih, ki jemljejo zdravilo Ziagen, razvije preobčutljivostna reakcija (resna alergijska reakcija), ki je lahko življenjsko ogrožujoča, če zdravljenje z zdravilom Ziagen nadaljujejo.
English: Children from one year of age: The recommended dose is 8 mg/kg twice daily or 16 mg/kg once daily, up to a maximum total daily dose of 600 mg (30 ml).
Slovenian: Otroci, od enega leta starosti: Priporočeni odmerek znaša 8 mg/kg dvakrat na dan, do skupno največ 600 mg (30ml) na dan.
English: Before initiating abacavir therapy, clinicians should screen for HLA-B*5701.
Slovenian: Pred začetkom uvedbe zdravljenja z abakavirjem morajo zdravniki izvesti presejanje za HLA-B*5701.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART) 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 (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe.
English: Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years.
Slovenian: Po dvoletnem dajanju abakavirja mišim in podganam so na njihovem srcu opazili blago miokardialno degeneracijo.
English: Children receiving abacavir oral tablets according to the recommended dosage regimen achieve higher plasma abacavir exposure than children receiving oral solution because higher mg/kg doses are administered with the tablet formulation.
Slovenian: Otroci, ki prejemajo abakavir v obliki peroralnih tablet po priporočenem režimu odmerjanja, dosežejo višjo izpostavljenost abakavirju v plazmi kot otroci, ki prejemajo peroralno raztopino; v obliki tablet se namreč dajejo višji odmerki (v mg/kg).
English: 1.Combivir is a fixed dose combination of lamivudine and zidovudine 2.Includes three non-virological failures and four unconfirmed virological failures.
Slovenian: 2.Vključuje tri nevirusne neuspehe in štiri nepotrjene virusne neodzive.
English: Myocardial Infarction
Slovenian: Miokardni infarkt
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 na dan, pri čemer je bil pred obdobjem 24-urnega jemanja vzorcev dan le en 300 mg odmerek, je bil geometrični srednji končni znotrajcelični razpolovni čas karbovir-5'-trifosfata v stanju dinamičnega ravnovesja 20,6 ur.
English: Microcrystalline cellulose Sodium starch glycollate Magnesium stearate Colloidal anhydrous silica
Slovenian: Jedro mikrokristalna celuloza natrijev karboksimetilškrob magnezijev stearat brezvoden koloidni silicijev dioksid
English: The Ziagen pack includes an Alert Card, to remind you and medical staff about abacavir hypersensitivity.
Slovenian: Pakiranje zdravila Ziagen vsebuje opozorilno kartico kot opozorilo o preobčutljivosti na abakavir za vas in medicinsko osebje.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Detach enclosed Alert Card, it contains important safety information
Slovenian: Odtrgajte priloženo opozorilno kartico, ki vsebuje pomembne informacije o varnosti.
English: There was a low, similar overall incidence of virologic failure (viral load >50 copies/ml) in both the once and twice daily treatment groups (10% and 8% respectively).
Slovenian: Pri obeh režimih zdravljenja je bil virusni neodziv (virusna obremenitev > 50 kopij/ml) podoben ter nizek: v skupini z režimom odmerjanja enkrat na dan 10 % in v skupini z režimom odmerjanja dvakrat na dan 8 %.
English: Use the oral dosing syringe supplied with the pack to measure your dose accurately.
Slovenian: Da boste natančno odmerili odmerek vašega zdravila, uporabite ovojnini priloženo peroralno odmerno brizgo.
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.
Slovenian: IC50 abakavirja (0,08 µg/ml ali 0,26 µM) pri odmerku 600 mg abakavirja dvakrat dnevno.
English: After a median follow-up of 144 weeks, 25% of subjects on the ZDV/3TC/ABC/EFV arm and 26% on the ZDV/3TC/EFV arm were categorised as having virological failure.
Slovenian: Po povprečno 144 tednih spremljanja je bil virološki neuspeh opažen pri 25 % oseb, ki so prejemale ZDV/3TC/ABC/EFV, in 26 % oseb, ki so prejemale ZDV/3TC/EFV.
English: Slowly push the plunger in, allowing time to swallow.
Slovenian: Počasi pritiskajte na bat in si s tem vzemite potreben čas, da lahko zdravilo pogoltnete.
English: In pregnant women, 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 of abacavir.
Slovenian: 1000 izidov po izpostavljenosti po drugem in tretjem trimesečju, ki ne kažejo na malformacijske učinke abakavirja ali njegovih učinkov na plod/novorojenčka.
English: Overall the available data from observational cohorts and from randomised trials show some inconsistency so can neither confirm nor refute a causal relationship between abacavir treatment and the risk of myocardial infarction.
Slovenian: Podatki iz kliničnih študij so pokazali omejeno število miokardnih infarktov, kar ne more izključiti majhnega povečanja tveganja.V celoti dostopni podatki iz opazovalnih skupin in randomiziranih študij kažejo nekaj neskladnosti in ne morejo niti potrditi niti ovreči vzročne povezave med zdravljenjem z abakavirjem in tveganjem za miokardni infarkt.
English: Marketing Authorisation Holder: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands
Slovenian: Imetnik dovoljenja za promet: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Nizozemska
English: Liver disease
Slovenian: Bolezen jeter
English: Abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine.
Slovenian: Abakavir se presnavlja predvsem v jetrih, pri čemer se ga 2 % izloči v nespremenjeni obliki s sečem.
English: No definitive dose recommendation can be made in patients with mild hepatic impairment (Child-Pugh score 5-6).
Slovenian: Za bolnike z blago jetrno okvaro (Child-Pugh ocena 5-6) ni možno pripraviti dokončnih priporočil za odmerjanje.
English: 2 to 12 years (N=14) PENTA 15 3 to 36 months (N=18)
Slovenian: PENTA 13 Od 2 do 12 let (n = 14)
English: This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily (see sections 4.4 and 5.1).
Slovenian: 300 mg (ena tableta) dvakrat na dan ali kot 600 mg (dve tableti) enkrat na dan (glejte poglavji 4.4 in
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%).
Slovenian: Odpornost in vivo (bolniki, ki še niso bili zdravljeni): V ključnih kliničnih preskušanjih pri izolatih večine bolnikov z virusnim neodzivom pri zdravljenju z režimom, ki je vseboval abakavir, bodisi niso odkrili z NRTI povezanih sprememb od izhodišča (45 %) ali pa so odkrili le selekcijo M184V ali
English: In the intent-to-treat (ITT) population, 70% of patients in the abacavir group, compared to 69% of patients in the zidovudine group, achieved a virologic response of plasma HIV-1 RNA ≤50 copies/ml by Week 48 (point estimate for treatment difference: 0.8, 95% CI -6.3, 7.9).
Slovenian: V populaciji vseh vključenih bolnikov (ITT population - »intet-to-treat population«) je bil pri 70 % bolnikov, ki so prejemali abakavir, in pri 69 % bolnikov, ki so prejemali zidovudin ,v 48. tednu dosežen virusni odziv s plazemsko HIV-1 RNA ≤ 50 kopij/ml (ocenjena vrednost v razliki zdravljenja: 0,8; 95 % interval zaupanja; -6,3; 7,9).
English: Other common symptoms are: • nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness
Slovenian: Drugi pogosti simptomi so: • slabost, bruhanje, driska, bolečine v trebuhu, huda utrujenost.
English: At therapeutic dosages a dosage of 300 mg twice daily, the mean (CV) steady state Cmax and Cmin of abacavir are approximately 3.00 µg/ml (30%) and 0.01 µg/ml (99%), respectively.
Slovenian: Pri terapevtskem odmerku 300 mg dvakrat na dan je srednja (CV) Cmax abakavirja v stanju dinamičnega ravnovesja približno 3,00 µg/ml (30 %) in Cmin abakavirja v stanju dinamičnega ravnovesja približno 0,01 µg/ml (99 %).
English: Therefore Ziagen can be taken with or without food.
Slovenian: Zato se zdravilo Ziagen lahko jemlje s hrano ali brez nje.
English: Methylhydroxypropylcellulose Titanium dioxide Polysorbate 80
Slovenian: Filmska obloga gliceriltriacetat hipromeloza titanov dioksid polisorbat 80 rumeni železov oksid
English: Plasma HIV-1 RNA <80 c/ml Risk difference (once daily-twice daily)
Slovenian: HIV-1 RNA v plazmi < 80 kopij/ml Razlika v tveganju (enkrat na dandvakrat na dan)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - TABLETE
English: (e.g.Triumeq, Trizivir or Kivexa).
Slovenian: zdravilo Trizivir, Triumeq ali Kivexa).
English: In study CAL30001, 182 treatment-experienced patients with virologic failure were randomised and received treatment with either the fixed-dose combination of abacavir/lamivudine (FDC) 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.
Slovenian: 182 bolnikov, pri katerih je pri predhodnem zdravljenju prišlo do virusnega neodziva, je bilo v študiji CAL30001 randomiziranih tako, da so 48 tednov prejemali bodisi kombinacijo abakavir/lamivudin v fiksnem odmerku (FDC - »fixed-dose combination«) enkrat na dan bodisi abakavir v odmerku 300 mg dvakrat na dan in lamivudin v odmerku 300 mg enkrat na dan, v obeh primerih v kombinaciji s tenofovirjem in PI ali NNRTI.
English: However, Ziagen is not recommended for patients with end-stage renal disease (see section 5.2).
Slovenian: Vendar pa se zdravila Ziagen ne priporoča v končnem stadiju ledvičnega obolenja (glejte poglavje 5.2).
English: Close the bottle tightly with the cap, leaving the adapter in place
Slovenian: Plastenko dobro zaprite s pokrovčkom, pri tem pa pustite plastični nastavek na mestu.
English: In a multicentre, double-blind, controlled study (CNA30024), 654 HIV-infected, antiretroviral therapy-naïve patients were randomised to receive either abacavir 300 mg twice daily or zidovudine 300 mg twice daily, both in combination with lamivudine 150 mg twice daily and efavirenz 600 mg once daily.
Slovenian: V multicentrični, dvojno slepi, nadzorovani študiji (CNA30024) je bilo 654 z virusom HIV okuženih bolnikov, ki še niso bili zdravljeni s protiretrovirusnimi zdravili, randomiziranih tako, da so bodisi prejemali abakavir v odmerku 300 mg dvakrat na dan bodisi zidovudin v odmerku 300 mg dvakrat na dan.
English: Clinical relevance in human of these data is unknown.
Slovenian: Klinična pomembnost teh ugotovitev na ljudeh ni znana.
English: There are insufficient safety data to recommend the use of Ziagen in infants less than three months old.
Slovenian: Za dojenčke, mlajše od treh mesecev, nimamo dovolj podatkov o varnosti zdravila Ziagen, da bi ga priporočili za uporabo.
English: Intracellular pharmacokinetics
Slovenian: Znotrajcelična farmakokinetika
English: Abacavir is rapidly and well absorbed following oral administration.
Slovenian: Pri peroralnem dajanju se abakavir hitro in dobro absorbira.
English: The active substance in each Ziagen film-coated, scored tablet is 300 mg of abacavir (as sulfate).
Slovenian: Zdravilna učinkovina v vsaki filmsko obloženi tableti Ziagen z zarezo je 300 mg abakavirja (v obliki sulfata).
English: Ziagen is also available as an oral solution for use in children over three months of age and weighing less than 14 kg and for those patients for whom the tablets are inappropriate.
Slovenian: Za uporabo pri otrocih, starejših od treh mesecev, s telesno maso manjšo od 14 kg, in bolnikih, pri katerih zdravljenje s tabletami ni primerno, je zdravilo Ziagen na voljo tudi v obliki peroralne raztopine.
English: The other ingredients are sorbitol 70% (E420), saccharin sodium, sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), maltodextrin, lactic acid, glyceryl triacetate, artificial strawberry and banana flavour, purified water, sodium hydroxide and/or hydrochloric acid for pH adjustment.
Slovenian: Pomožne snovi so sorbitol 70 % (E420), natrijev saharinat, natrijev citrat, brezvodna citronska kislina, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), propilenglikol (E1520),
English: Medicinal product subject to medical prescription
Slovenian: Odlašanje s prenehanjem zdravljenja z zdravilom
English: Each film-coated tablet contains 300 mg abacavir (as sulfate).
Slovenian: Ena filmsko obložena tableta vsebuje 300 mg abakavirja (v obliki sulfata).
English: This may be administered as either 150 mg (one half of a tablet) twice daily or 300 mg (one whole tablet) once daily.
Slovenian: Odmerek se lahko daje v obliki 150 mg odmerka (polovica tablete) dvakrat na dan ali v obliki 300 mg odmerka (ena cela tableta) enkrat na dan.
English: Adults, adolescents and children weighing at least 25 kg
Slovenian: Koliko zdravila morate vzeti Odrasli, mladostniki in otroci, ki tehtajo vsaj 25 kg
English: Insert the syringe firmly into the adapter
Slovenian: Odmerno brizgo trdno vstavite v nastavek.
English: Phenotypic resistance to abacavir requires M184V with at least one other abacavir-selected mutation, or M184V with multiple TAMs.
Slovenian: Fenotipska odpornost in navzkrižna odpornost 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: No definitive recommendation on dosage reduction is possible in patients with mild hepatic impairment due to the substantial variability of abacavir exposure.
Slovenian: Zaradi znatne variabilnosti v izpostavljenosti abakavirju pri bolnikih z blago jetrno okvaro ni mogoče dati dokončnih priporočil o zmanjšanju odmerka.
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte s svojiim zdravnikom ali farmacevtom.
English: take Ziagen, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Kivexa).
Slovenian: VZETI zdravila Ziagen ali drugega zdravila, ki vsebuje abakavir (npr. Kivexa, Trizivir ali Triumeq),
English: Many of the adverse reactions listed below occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity.
Slovenian: Številni, spodaj navedeni neželeni učinki se pri bolnikih s preobčutljivostjo na abakavir pojavijo pogosto (navzea, bruhanje, diareja, povišana telesna temperatura, letargija, izpuščaj).
English: This may be administered as either one 150 mg (one half of a tablet) taken in the morning and 300 mg (one whole tablet) taken in the evening, or 450 mg (one and a half tablets) taken once daily.
Slovenian: Odmerek se lahko daje v obliki 150 mg odmerka (polovica tablete) zjutraj in v obliki 300 mg odmerka (ena cela tableta) zvečer ali v obliki 450 mg odmerka (ena tableta in pol) enkrat na dan.
English: Artificial strawberry and banana flavours Purified water
Slovenian: maltodekstrin, mlečna kislina, gliceriltriacetat, umetna aroma jagode in banane, prečiščena voda,
English: If the doctor thinks they may have been, you will then be told never again to take Ziagen, or any other medicine containing abacavir (e.g. Trizivir , Triumeq or Kivexa).
Slovenian: Če zdravnik oceni, da so morda povezani, vam bo naročil, da ne smete nikdar več jemati zdravila Ziagen ali drugih zdravil, ki vsebujejo abakavir (npr. Triumeq, Trizivir ali Kivexa).
English: 1206 paediatric patients aged 3 months to 17 years enrolled in the ARROW Trial (COL105677) and were dosed according to the weight - band dosing recommendations in the World Health Organisation treatment guidelines (Antiretroviral therapy of HIV infection in infants and children, 2006).
Slovenian: Pediatrična populacija: V okviru randomizirane, multicentrične, kontrolirane študije z virusom HIV okuženih pediatričnih bolnikov, je bila opravljena randomizirana primerjava režima odmerjanja abakavirja in lamivudina enkrat v primerjavi z dvakrat na dan. 1206 pediatričnih bolnikov, starih od 3 mesece do 17 let, so vključili v preskušanje ARROW (COL105677) in so prejemali odmerke v skladu z odmernimi priporočili glede na telesno maso po terapevtskih smernicah Svetovne zdravstvene organizacije (Protiretrovirusno zdravljenje okužbe s HIV pri dojenčkih in otrocih, 2006).
English: Ziagen 300 mg film-coated tablets
Slovenian: Ziagen 300 mg filmsko obložene tablete
English: Lactic acid
Slovenian: Hematologija limfopenija
English: These were primarily asymptomatic HIV infected patients - Centre for Disease Control and Prevention (CDC) stage A. They were randomised to receive either abacavir 600 mg once daily or 300 mg twice daily, in combination with efavirenz and lamivudine given once daily.
Slovenian: Center za nadzor in preprečevanje bolezni (CDC) stadij A. Randomizirani so bili tako, da so prejemali abakavir v odmerku 600 mg enkrat na dan ali v odmerku 300 mg dvakrat na dan v kombinaciji z efavirenzem in lamivudinom enkrat na dan.
English: Fever, lethargy, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Slovenian: edem, limfadenopatija, hipotenzija, konjunktivitis, anafilaksija
English: Tell your doctor or pharmacist if any of the side effects get severe or troublesome, or if you notice any side effects not listed in this leaflet.
Slovenian: Če se vam pojavijo neželeni učinki Če katerikoli neželeni učinek postane resen ali moteč, ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: This can be taken either as 300 mg (15 ml) twice a day or 600 mg (30 ml) once a day.
Slovenian: dvakrat na dan ali 600 mg (30 ml) enkrat na dan.
English: Dosing according to weight bands is recommended for Ziagen tablets.
Slovenian: Pri uporabi zdravila Ziagen v obliki tablet priporočamo odmerjanje na osnovi telesne mase.
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.
Slovenian: Pri genotipski analizi je bilo na majhnem vzorcu ugotovljeno, da je tendenca pojava mutacij, povezanih z NRTI večja pri režimu odmerjanju abakavirja enkrat na dan kot pa pri režimu odmerjanja dvakrat na dan. Zaradi skopih podatkov, ki izhajajo iz te študije, pa zanesljivih zaključkov ne moremo podati.
English: • fever (high temperature) and skin rash
Slovenian: • povišana telesna temperatura (vročina), • izpuščaj na koži.
English: Results indicate that the FDC group was non-inferior to the abacavir twice daily group, based on similar reductions in HIV-1 RNA as measured by average area under the curve minus baseline (AAUCMB, -1.65 log10 copies/ml versus -1.83 log10 copies/ml respectively, 95% CI -0.13, 0.38).
Slovenian: kažejo, da je FDC skupina enakovredna skupini, ki je prejemala abakavir dvakrat na dan (AAUCMB; -1,65 log10 kopij/ml proti -1,83 log10 kopij/ml; interval zaupanja 95 %; -0,13, 0,38).
English: - fever - shortness of breath, sore throat or cough - nausea or vomiting or diarrhoea or abdominal pain - severe tiredness or achiness or generally feeling ill If you have discontinued Ziagen due to this reaction, YOU MUST NEVER TAKE Ziagen or any other abacavir containing medicine (e.g. Kivexa, Trizivir or Triumeq) again, as within hours you may experience a life-threatening lowering of your blood pressure or death.
Slovenian: - slabost ali bruhanje ali driska ali bolečine v trebuhu - močna utrujenost ali bolečine ali splošno slabo počutje Če ste zdravilo Ziagen prenehali jemati zaradi preobčutljivostne reakcije, NIKOLI VEČ NE SMETE
English: Methyl parahydroxybenzoate (E218) 1.5 mg/ml Propyl parahydroxybenzoate (E216) 0.18 mg/ml For the full list of excipients see section 6.1.
Slovenian: sorbitol (E420) 340 mg/ml metilparahidroksibenzoat (E218) 1,5 mg/ml propilparahidroksibenzoat (E216) 0,18 mg/ml
English: Combination therapy including Ziagen may cause other conditions to develop during HIV treatment.
Slovenian: Drugi možni neželeni učinki kombiniranega zdravljenja okužbe s HIV Kombinirano zdravljenje, ki vključuje zdravilo Ziagen, lahko med zdravljenjem okužbe s HIV povzroči nastanek drugih motenj.
English: In a pharmacokinetic study (PENTA 15), four virologically controlled subjects less than 12 months of age switched from abacavir plus lamivudine oral solution twice daily to a once daily regimen.
Slovenian: V farmakokinetični študiji (PENTA 15) so štirje virološko obvladani preiskovanci, mlajši od 12
English: If a twice daily regimen is not feasible, a once daily regimen (16 mg/kg/day) could be considered.
Slovenian: Če režim odmerjanja dvakrat na dan ni izvedljiv, se lahko razmisli o režimu odmerjanja 16 mg/kg/dan) enkrat na dan. Treba je upoštevati, da so podatki o enkrat dnevnem režimu odmerjanja za to populacijo omejeni (glejte poglavje 5.1 in 5.2).
English: You need to know about important signs and symptoms to look out for while you are taking Ziagen.
Slovenian: Medtem ko jemljete zdravilo Ziagen, morate biti seznanjeni s pomembnimi znaki in simptomi, na katere morate biti pozorni.