FrancophonIA/ELRC3.0 huggingface dataset:
English: Zerit belongs to a particular group of antiviral medicines, also known as antiretrovirals, called nucleoside reverse transcriptase inhibitors (NRTIs).
Slovenian: Zdravilo Zerit spada v podskupino protivirusnih zdravil, znanih tudi kot protiretrovirusna zdravila, ki jih imenujemo nukleozidni in nukleotidni zaviralci reverzne transkriptaze (NRTIs, “nucleoside reverse transcriptase inhibitors”).
English: * Patients on haemodialysis should take Zerit after the completion of haemodialysis, and at the same time on non-dialysis days.
Slovenian: * Bolniki na hemodializi naj zdravilo Zerit vzamejo po koncu hemodialize, v dneh, ko nimajo dialize, pa ob istem času.
English: Given these potential risks, a benefit-risk assessment for each patient should be made and an alternative antiretroviral should be carefully considered (see section 4.4 and below).
Slovenian: Zaradi teh možnih tveganj je potrebno pri vsakem bolniku oceniti koristi in tveganja ter natančno razmisliti o drugem protiretrovirusnem zdravljenju (glejte poglavje 4.4 in spodaj).
English: If you are allergic to stavudine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Zerit če ste alergični na zdravilno učinkovino ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Peripheral neuropathy was seen in combination studies of Zerit with lamivudine plus efavirenz; the frequency of peripheral neurologic symptoms was 19% (6% for moderate to severe) with a rate of discontinuation due to neuropathy of 2%.
Slovenian: Periferno nevropatijo so opazili v študijah, v katerih so zdravilo Zerit uporabljali v kombinaciji z lamivudinom in efavirenzom; pogostnost perifernih nevroloških simptomov je bila 19% (6% zmernih do hudih), delež prekinitev zaradi nevropatije je bil 2%.
English: It is recommended that HIV-infected women should not breast-feed under any circumstances in order to avoid transmission of HIV to the baby.
Slovenian: Priporočljivo je, da s HIV okužene ženske pod nobenim pogojem ne dojijo, da ne bi prišlo do prenosa HIV na otroka.
English: Before reconstitution the Zerit powder appears as off-white to pale-pink, gritty powder.
Slovenian: Pred rekonstitucijo je Zerit prašek sivobel do bledo rožnat zrnat prašek.
English: Treatment with stavudine (Zerit) often causes a loss of fat from legs, arms and face (lipoatrophy).
Slovenian: Zdravljenje s stavudinom (Zerit) pogosto povzroča izginotje maščobnega tkiva na nogah, rokah in obrazu (lipoatrofija).
English: The clinical relevance of these findings suggest that stavudine should be generally avoided in the presence of TAMs, especially M41L and T215Y.
Slovenian: Klinični pomen teh ugotovitev je, da se je v primeru prisotnosti mutacije timidinskih analogov, še posebej v primeru M41L in T215Y, treba običajno izogniti uporabi stavudina.
English: The HIV status for the newborns and infants ≤ 3 months of age was negative, for older infants it tended to be positive.
Slovenian: Novorojenčki in dojenčki stari ≤ 3 mesece so bili HIV-negativni, starejši dojenčki pa so bili praviloma pozitivni.
English: In the event of rapidly elevating transaminase levels (ALT/AST, > 5 times upper limit of normal, ULN), discontinuation of Zerit and any potentially hepatotoxic medicinal products should be considered.
Slovenian: Če raven transaminaz hitro poraste (ALT/AST > 5-kratna zgornja normalna meja, (ZNM)), je treba razmisliti o prenehanju uporabe zdravila Zerit in morebitnih drugih hepatotoksičnih zdravil.
English: Late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Slovenian: Redko so poročali o primerih nevroloških motenj, ki nastopijo kasneje (hipertonija, konvulzije, nenormalno obnašanje).
English: When reconstituted with 202 ml of water, produces 210 ml of a colorless to slightly pink, hazy solution.
Slovenian: Po dodajanju 202 ml vode dobimo 210 ml brezbarvne do rahlo rožnate motne raztopine.
English: Cellular DNA polymerase γ is also sensitive to inhibition by stavudine triphosphate, while cellular polymerases α and β are inhibited at concentrations 4,000-fold and 40-fold higher, respectively, than that needed to inhibit HIV reverse transcriptase.
Slovenian: Na zavrtje s stavudintrifosfatom je občutljiva tudi celična DNA-polimeraza γ, medtem ko je za zavrtje celične polimeraze α potrebna 4.000-krat večja, za zavrtje celične polimeraze β pa 40-krat večja koncentracija kot za zavrtje reverzne transkriptaze HIV.
English: Pancreatitis: patients with a history of pancreatitis had an incidence of approximately 5% onZerit, as compared to approximately 2% in patients without such a history.
Slovenian: Pankreatitis: Pri bolnikih z anamnezo pankreatitisa je incidenca med uporabo zdravila Zerit približno 5%, pri bolnikih brez takšne anamneze pa približno 2%.
English: During treatment, other infections linked to a weakened immunity (opportunistic infections) may arise.
Slovenian: Med zdravljenjem se lahko pojavijo druge okužbe (oportunistične okužbe), povezane z oslabelo imunostjo.
English: Do not take Zerit if you are taking didanosine, used to treat HIV infection.
Slovenian: Ne jemljite zdravila Zerit, če jemljete didanozin, ki se uporablja za zdravljenje okužbe z virusom HIV.
English: Zerit contains sucrose and preservatives
Slovenian: Zdravilo Zerit vsebuje saharozo in konzervanse
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Slovenian: Pri bolnikih z že obstoječo disfunkcijo jeter (s kroničnim aktivnim hepatitisom vred) se med kombiniranim protiretrovirusnim zdravljenjem pogosteje pojavljajo nepravilnosti v delovanju jeter, zato jih je treba nadzirati v skladu s standardno prakso.
English: Treatment naive pregnant women were enrolled into the study at gestation week 34-36 and given antiretroviral treatment until delivery.
Slovenian: V raziskavo so vključili nosečnice v obdobju od 34. do 36. gestacijskega tedna, ki še niso bile zdravljene s protiretrovirusnimi zdravili in so do poroda dobivale protiretrovirusno zdravljenje.
English: Children from birth to 13 days old should receive 0.5 mg/kg twice daily.
Slovenian: Otroci od rojstva do 13. dne starosti morajo dobivati 0,5 mg/kg dvakrat na dan.
English: Given these potential risks, a benefit-risk assessment for each patients should be made and an alternative antiretroviral should be carefully considered (see Lactic acidosis, Lipoatrophy, and Peripheral neuropathy below and section 4.8).
Slovenian: Zaradi teh možnih tveganj je potrebno pri vsakem bolniku oceniti koristi in tveganja ter natančno razmisliti o drugih možnostih protiretrovirusnega zdravljenja (glejte Laktacidoza, Lipoatrofija ter Periferna nevropatija spodaj in poglavje 4.8).
English: Mitochondrial dysfunction: review of the postmarketing safety database shows that adverse reactions indicative of mitochondrial dysfunction have been reported in the neonate and infant population exposed to one or more nucleoside analogues (see also section 4.4).
Slovenian: Moteno delovanje mitohondrijev: Pregled zbirke podatkov o varnosti, zbranih v obdobju po pridobitvi dovoljenja za promet, kaže, da so se v populaciji novorojenčkov in dojenčkov, izpostavljenih enemu ali več nukleozidnim analogom, pojavili neželeni učinki, ki nakazujejo moteno delovanje mitohondrijev (glejte tudi poglavje 4.4).
English: A study in asymptomatic patients demonstrated that systemic exposure is similar while Cmax is lower and Tmax is prolonged when stavudine is administered with a standardised, high-fat meal compared with fasting conditions.
Slovenian: Raziskava pri asimptomatskih bolnikih je pokazala, da je v primeru uporabe stavudina s standardiziranim, zelo mastnim obrokom, sistemska izpostavljenost podobna kot v pogojih na tešče, medtem ko je Cmax manjša, tmax pa daljši.
English: The powder contains 200 mg stavudine.
Slovenian: Prašek vsebuje 200 mg stavudina.
English: Cmax and AUC increased proportionally with dose in the dose ranges, intravenous 0.0625-0.75 mg/kg, and oral 0.033-4.0 mg/kg.
Slovenian: Cmax in AUC sta se v območju intravenskih odmerkov od 0,0625 do 0,75 mg/kg in peroralnih od 0,033 do 4,0 mg/kg zvečevali sorazmerno.
English: What Zerit looks like and content of the pack
Slovenian: Izgled zdravila Zerit in vsebina pakiranja
English: No carcinogenicity was noted at doses of 400 mg/kg/day in mice and 600 mg/kg/day in rats, corresponding to exposures ~ 39 and 168 times the expected human exposure, respectively, suggesting an insignificant carcinogenic potential of stavudine in clinical therapy.
Slovenian: Ob odmerkih 400 mg/kg/dan pri miših oz. 600 mg/kg/dan pri podganah (ki ustrezata izpostavljenosti ~ 39- oz. 168-krat pričakovani izpostavljenosti pri človeku) niso zabeležili kancerogenosti, kar nakazuje, da je kancerogeni potencial stavudina med kliničnim zdravljenjem nepomemben.
English: CD4 Mean Change from Baseline, cells/mm3 All patients
Slovenian: Srednja sprememba vrednosti števila celic CD4 od izhodišča, celice/mm3 Vsi bolniki
English: Stavudine therapy is associated with several severe side effects, such as lactic acidosis, lipoatrophy and polyneuropathy, for which a potential underlying mechanism is mitochondrial toxicity.
Slovenian: Zdravljenje s stavudinom je povezano s številnimi hudimi neželenimi učinki, kot so laktacidoza, lipoatrofija in polinevropatija, za katere je možen mehanizem nastanka mitohondrijska toksičnost.
English: SPECIAL STORAGE CONDITIONS Store below 25°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25°C.
English: If you notice any symptoms of infection, please inform your doctor immediately.
Slovenian: Če opazite kakršnekoli znake okužbe, o tem nemudoma obvestite svojega zdravnika.
English: If this is not possible, Zerit may also be taken with a light meal.
Slovenian: Če to ni mogoče, se lahko zdravilo Zerit vzame tudi z lahkim obrokom.
English: The total clearance of stavudine appears to be higher in HIV-infected patients, while the renal clearance is similar between healthy subjects and HIV-infected patients.
Slovenian: Kaže, da je celotni očistek stavudina pri bolnikih, okuženih z virusom HIV, večji, ledvični očistek pa podoben kot pri zdravih prostovoljcih.
English: Preliminary safety data from this study (see also section 4.8), showed an increased infant mortality in the stavudine + didanosine (10%) treatment group compared to the stavudine (2%), didanosine (3%) or zidovudine (6%) groups, with a higher incidence of stillbirths in the stavudine + didanosine group.
Slovenian: Preliminarni podatki o varnosti iz te raziskave (glejte tudi poglavje 4.8) kažejo večjo umrljivost dojenčkov (10%) v skupini, zdravljeni s stavudinom in didanozinom, kot v skupinah, zdravljenih s stavudinom (2%), didanozinom (3%) ali zidovudinom (6%).
English: No notable differences in the frequency of adverse drug reactions were seen between treatment groups.
Slovenian: Med terapevtskimi skupinami niso ugotovili opaznih razlik v pogostnosti neželenih učinkov na zdravilo.
English: During therapy with Zerit there is often a gradual loss of subcutaneous fat (fat found beneath the skin), which is most notable in the face and on the legs and arms.
Slovenian: Med zdravljenjem z zdravilom Zerit je pogosta postopna izguba podkožnega maščevja (maščevje, ki se nahaja pod kožo), ki je najbolj opazna na obrazu, udih in zadnjici.
English: If you are taking didanosine, used to treat HIV infection
Slovenian: če jemljete didanozin, ki se uporablja za zdravljenje okužbe z virusom HIV
English: How to take Zerit
Slovenian: Kako jemati zdravilo Zerit
English: Intra- and interindividual variation in pharmacokinetic characteristics of stavudine is low, approximately 15% and 25%, respectively, after oral administration.
Slovenian: Intra- in interindividualne razlike v farmakokinetičnih značilnostih stavudina po peroralni uporabi so majhne (približno 15% intra- in 25% interindividualno).
English: Do not store the dry powder above 30°C.
Slovenian: Suhi prašek shranjujte pri temperaturi do 30 °C.
English: The profile of the adverse events for newborns and infants ≤ 3 months of age showed increases in lactic acid levels, neutropenia, anaemia, thrombocytopenia, hepatic transaminase increases and increased lipids, including hypertriglyceridaemia.
Slovenian: Značilnosti neželenih učinkov pri novorojenčkih in dojenčkih, starih ≤ 3 mesece, so bile zvečanje koncentracije mlečne kisline, nevtropenija, anemija, trombocitopenija, zvišanje jetrnih transaminaz in zvišanje lipidov, vključno s hipertrigliceridemijo.
English: Stavudine, a thymidine analogue, is phosphorylated by cellular kinases to stavudine triphosphate which inhibits HIV reverse transcriptase by competing with the natural substrate, thymidine triphosphate.
Slovenian: Timidinski analog stavudin celične kinaze fosforilirajo v stavudintrifosfat, ki zavira reverzno transkriptazo HIV, ker tekmuje z naravnim substratom, timidintrifosfatom.
English: For optimal absorption, Zerit should be taken on an empty stomach (i.e. at least 1 hour prior to meals) but, if this is not possible, it may be taken with a light meal.
Slovenian: Za optimalno absorpcijo mora bolnik zdravilo Zerit vzeti na prazen želodec (to je vsaj 1 uro pred obrokom), če pa to ni mogoče, ga lahko vzame tudi skupaj z lahkim obrokom.
English: When these signs occur, Zerit should be stopped and your HIV treatment changed.
Slovenian: Če se ti znaki pojavijo, je treba prekiniti zdravljenje z zdravilom ZERIT ter spremeniti vaše zdravljenje za HIV.
English: Adverse reactions of moderate or greater severity with at least a possible relationship to treatment regimen (based on investigator attribution) reported from 467 patients treated with Zerit in combination with lamivudine and efavirenz in two randomised clinical trials and along-term follow-up study (follow-up: median 56 weeks ranging up to 119 weeks) are listed below.
Slovenian: Neželeni učinki (zmerni do hudi), ki bi lahko bili povezani z zdravljenjem (na osnovi presoje raziskovalca) in o katerih so poročali pri 467 bolnikih, zdravljenih z zdravilom Zerit v kombinaciji z lamivudinom in efavirenzom v dveh randomiziranih kliničnih preskušanjih in v potekajoči dolgoročni spremljevalni študiji (srednja vrednost skupnega časa spremljanja: 56 tednov z razponom do 119 tednov), so navedeni spodaj.
English: Osteonecrosis: although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Slovenian: Osteonekroza: čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART - combination antiretroviral therapy) ali obojim.
English: common: peripheral neurologic symptoms including peripheral neuropathy, paresthesia, and peripheral neuritis; dizziness; abnormal dreams; headache, insomnia; abnormal thinking; somnolence very rare: motor weakness* (most often reported in the setting of symptomatic hyperlactatemia or lactic acidosis syndrome)
Slovenian: pogosti: periferni nevrološki simptomi, vključno s periferno nevropatijo, parestezijami in perifernim nevritisom; omotica; nenormalne sanje; glavobol, nespečnost; nenormalno mišljenje; zaspanost zelo redki: motorična šibkost* (najpogosteje opisana v primeru simptomatske hiperlaktatemije ali sindroma laktacidoze)
English: uncommon: hepatitis or jaundice rare: hepatic steatosis* very rare: liver failure*
Slovenian: občasni: hepatitis ali zlatenica redki: hepatična steatoza* zelo redki: odpoved jeter*
English: The mean terminal elimination half-life of stavudine is 1.3 to 2.3 hours following single or multiple doses, and is independent of dose.
Slovenian: Po enkratnem in ponavljajočih se odmerkih srednji končni razpolovni čas izločanja stavudina znaša od 1,3 do 2,3 ure in ni odvisen od odmerka.
English: Peripheral neuropathy: if symptoms of peripheral neuropathy develop (usually characterised by persistent numbness, tingling, or pain in the feet and/or hands) (see section 4.4), patients should be switched to an alternative treatment regimen, if appropriate.
Slovenian: Periferna nevropatija: Če se pojavijo simptomi periferne nevropatije (njena značilnost so ponavadi dolgotrajna omrtvelost, mravljinčenje ali bolečine v stopalih in/ali dlaneh) (glejte poglavje 4.4), je treba zdravljenje zamenjati z alternativnim, če je to primerno.
English: These studies include ACTG 240, where 105 paediatric patients ages 3 months to 6 years received Zerit 2 mg/kg/day for a median of 6.4 months; a controlled clinical trial where 185 newborns received Zerit 2 mg/kg/day either alone or in combination with didanosine from birth through 6 weeks of age; and a clinical trial where 8 newborns received Zerit 2 mg/kg/day in combination with didanosine and nelfinavir from birth through 4 weeks of age.
Slovenian: Te raziskave vključujejo ACTG 240, v kateri je 105 pediatričnih bolnikov, starih od 3 mesece do 6 let, dobivalo zdravilo Zerit v odmerku 2 mg/kg/dan 6,4 mesece (srednja vrednost trajanja terapije); kontrolirano klinično raziskavo, v kateri je 185 novorojenčkov dobivalo zdravilo Zerit v odmerku 2 mg/kg/dan bodisi samega ali v kombinaciji z didanozinom, in sicer od rojstva do 6 tednov starosti ter klinično raziskavo, v kateri je 8 novorojenčkov dobivalo zdravilo Zerit v odmerku 2 mg/kg/dan v kombinaciji z didanozinom in nelfinavirom od rojstva do 4 tedna starosti.
English: To help protect the capsules from excessive moisture, the bottle includes a desiccant canister.
Slovenian: Za zaščito kapsul pred čezmerno vlago je v plastenki tudi vložek s sušilom.
English: Treatment with stavudine should be discontinued if there is symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Slovenian: Če se pojavijo simptomatska hiperlaktatemija in metabolična acidoza/laktacidoza, napredujoča hepatomegalija ali hitro zviševanje aminotransferaz, je treba zdravljenje s stavudinom prekiniti.
English: Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness).
Slovenian: Zgodnji simptomi (simptomatska hiperlaktatemija) vključujejo blage prebavne težave (navzeo, bruhanje in bolečine v trebuhu), nespecifično splošno slabo počutje, izgubo teka, hujšanje, respiratorne simptome (hitro in/ali globoko dihanje) ali nevrološke simptome (vključno z motorično šibkostjo).
English: Data on lactic acid in serum were not collected in this study.
Slovenian: V tej raziskavi niso zbirali podatkov o mlečni kislini v serumu.
English: Each bottle contains 31.5 mg of propylhydroxybenzoate (E216) Each bottle contains 315 mg of methylhydroxybenzoate (E218) Each bottle contains 10.15 g of sucrose
Slovenian: Ena plastenka vsebuje 31,5 mg propilparahidroksibenzoata (E216) Ena plastenka vsebuje 315 mg metilparahidroksibenzoata (E218) Ena plastenka vsebuje 10,15 g saharoze
English: Liver disease: hepatitis or liver failure, which was fatal in some cases, has been reported.
Slovenian: Bolezni jeter: Opisani so primeri hepatitisa ali odpovedi jeter, ki je bila v nekaterih primerih usodna.
English: Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected adult patients and paediatric patients (over the age of 3 months) only when other antiretrovirals can not be used.
Slovenian: Zdravilo Zerit je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje okužbe z virusom HIV pri odraslih in otrocih (starejših od 3 mesecev), vendar le, če uporaba drugih protiretrovirusnih zdravil ni mogoča.
English: Co-administration with didanosine due to the potential for serious and/or life-threatening events notably lactic acidosis, liver function abnormalities, pancreatitis and peripheral neuropathy (see sections 4.4 and 4.5).
Slovenian: Sočasna uporaba z didanozinom, zaradi možnosti pojava resnih in/ali življenje ogrožujočih neželenih učinkov, zlasti laktacidoze, nepravilnega delovanja jeter, pankreatitisa ali periferne nevropatije (glejte poglavji 4.4 in 4.5).
English: HDPE bottle with child resistant screw cap, fill mark (200 ml of solution after reconstitution) and measuring cup.
Slovenian: HDPE plastenka z za otroke varno navojno zaporko, polnilno oznako (200 ml raztopine po pripravi) in odmerno čašo.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: In vitro, stavudine triphosphate has an intracellular half-life of 3.5 hours in CEM T-cells (a human T-lymphoblastoid cell line) and peripheral blood mononuclear cells, supporting twice daily dosing.
Slovenian: In vitro na CEM T-celicah (celična linija humanih T-limfoblastoidnih celic) in mononuklearnih celicah iz periferne krvi znotrajcelični razpolovni čas stavudintrifosfata znaša 3,5 ure, kar podpira odmerjanje zdravila dvakrat na dan.
English: EXPIRY DATE EXP
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI EXP
English: Metabolites include oxidised stavudine, glucuronide conjugates of stavudine and its oxidised metabolite, and an N-acetylcysteine conjugate of the ribose after glycosidic cleavage, suggesting that thymine is also a metabolite of stavudine.
Slovenian: Presnovki vključujejo oksidirani stavudin, glukuronidne konjugate stavudina in njegove oksidirane presnovke ter N-acetilcisteinski konjugat riboze po glikozidnem cepljenju, kar kaže, da je timin tudi presnovek stavudina.
English: The decrease of susceptibility in vitro is subtle requiring two or more TAMs (generally M41L and T215Y) before stavudine susceptibility is decreased (> 1.5 fold).
Slovenian: Potrebni sta dve mutaciji timidinskih analogov ali več (običajno M41L in T215Y), preden se občutljivost za stavudin zmanjša (> 1,5-krat).
English: Immune reactivation syndrome: 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 (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
English: Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used.
Slovenian: Zdravilo Zerit je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje okužbe z virusom HIV pri odraslih in otrocih (od rojstva), vendar le, če uporaba drugih protiretrovirusnih zdravil ni mogoča.
English: Keep the bottle tightly closed.
Slovenian: Shranjujte v tesno zaprti plastenki.
English: 20 mg twice daily 20 mg every 24 hours
Slovenian: 20 mg dvakrat na dan 20 mg na 24 ur
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: Bolnike s kroničnim hepatitisom B ali C, ki dobivajo kombinirano protiretrovirusno zdravljenje, bolj ogrožajo hudi in potencialno usodni neželeni učinki na jetrih.