FrancophonIA/ELRC3.0 huggingface dataset:
English: Liver disease: hepatitis or liver failure, which was fatal in some cases, has been reported.
Croatian: Bolest jetre: prijavljen je hepatitis ili zatajenje jetre, koje je u nekim slučajevima bilo fatalno.
English: Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF04
Croatian: Farmakoterapijska grupa: Antiviroticiza sustavnu primjenu, nukleozidni i nukleotidni inhibitori reverzne transkriptaze, ATK oznaka: J05AF04
English: PHARMACEUTICAL FORM AND CONTENTS 56 hard capsules
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ 56 tvrdih kapsula
English: Children from birth to 13 days old should receive 0.5 mg/kg twice daily.
Croatian: Djeca od rođenja do 13 dana starosti trebaju primiti 0,5 mg/kg dva puta na dan.
English: In vitro studies indicate that the activation of stavudine is inhibited by doxorubicin and ribavirin but not by other medicinal products used in HIV infection which are similarly phosphorylated, (e.g. didanosine, zalcitabine, ganciclovir and foscarnet) therefore, coadministration of stavudine with either doxorubicin or ribavirin should be undertaken with caution.
Croatian: In vitro ispitivanja pokazuju da aktivaciju stavudina inhibiraju doksorubicin i ribavirin, ali ne i drugi lijekovi koji se upotrebljavaju kod HIV-infekcije i koji su slično fosforilirani, (npr. didanozin, zalcitabin, ganciklovir i foskarnet) stoga, treba oprezno davati stavudin u kombinaciji s doksorubicinom ili ribavirinom.
English: Do not store above 30°C (HDPE bottles).
Croatian: Ne čuvati na temperaturi iznad 30°C. (HDPE boce)
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
Croatian: Jedna boca sadrži31,5 mg propilhidroksibenzoata (E216) Jedna boca sadrži 315 mg metilhidroksibenzoata (E218) Jedna boca sadrži 10,15 g saharoze
English: Patients continuing treatment with Zerit should be assessed frequently and switched to an alternative appropriate therapy whenever possible (see section 4.4).
Croatian: Bolesnike koji nastavljaju liječenje lijekom Zerit trebalo bi često procjenjivati i kad god je to moguće liječenje zamjeniti alternativnom prikladnom terapijom (vidjeti dio 4.4).
English: A rat study also showed placental transfer of stavudine, with the foetal tissue concentration approximately 50% of the maternal plasma concentration.
Croatian: Ispitivanje na štakorima također je pokazalo da stavudin prolazi kroz placentu, te da koncentracije u tkivu fetusa dosežu oko 50% vrijednosti koncentracije u plazmi majke.
English: Prepare the ready-to-use solution by mixing the powder with 202 ml of water or by slowly adding water up to the top edge of the bottle label shown by the arrow fill marks.
Croatian: Pripremite otopinu za korištenje miješajući prašak s 202 ml vode ili polaganim dodavanjem vode do gornjeg ruba naljepnice na boci ozanačenog strelicom.
English: What Zerit is and what it is used for
Croatian: Što je Zerit i za što se koristi
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.
Croatian: U slučaju brzog porasta razina transaminaza (ALT/AST,> 5 puta iznad gornje granice normalnih vrijednosti, ULN), treba razmotriti prekid primjene lijeka Zerit i potencijalno hepatotoksičnih lijekova.
English: How to take Zerit
Croatian: Kako uzimati Zerit
English: When reconstituted with 202 ml of water, produces 210 ml of a colorless to slightly pink, hazy solution.
Croatian: Kad se pripremi s 202 ml vode, nastane 210 ml bezbojne do lagano ružičaste, magličaste otopine.
English: Pancreatitis, occasionally fatal, has been reported in up to 2-3% of patients enrolled in monotherapy clinical studies (see section 4.4).
Croatian: Pankreatitis, ponekad sa smrtnim ishodom, zabilježen je u najviše 2-3% bolesnika uključenih u klinička ispitivanja monoterapije (vidjeti dio 4.4).
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.
Croatian: Profil nuspojava za novorođenčad i dojenčad ≤ 3 mjeseca starosti pokazivao je povišenu razinu laktatne kiseline, neutropeniju, anemiju, trombocitopeniju, porast jetrenih transaminaza i porast lipida, uključujući hipertrigliceridemiju.
English: A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy Aesica Queenborough Limited, North Road, Queenborough, Kent, ME11 5EL, United Kingdom The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italija Aesica Queenborough Limited, North Road, Queenborough, Kent, ME11 5EL, Ujedinjeno Kraljevstvo
English: HIV RNA < 400 copies/ml, treatment response, % All patients
Croatian: HIV RNA < 400 kopija/ml, terapijski odgovor (%) Svi bolesnici
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).
Croatian: Osteonekroza: iako se smatra da etiologija uključuje više čimbenika (uključujući upotrebu kortikosteroida, uzimanje alkohola, tešku imunosupresiju, viši indeks tjelesne mase), slučajevi osteonekroze su posebno prijavljivani u bolesnika s uznapredovalom HIV-infekcijom i/ili kod dugotrajne izloženosti kombiniranoj antiretrovirusnoj terapiji (CART).
English: In the rare cases when this is inappropriate, dose reduction of stavudine may be considered, while the symptoms of peripheral neuropathy are under close monitoring and satisfactory virological suppression is maintained.
Croatian: U rijetkim slučajevima kada navedeno nije moguće, može se razmotriti smanjivanje doze stavudina uz redovito praćenje simptoma periferne neuropatije i dok je održana zadovoljavajuća virološka supresija.
English: The powder contains 200 mg stavudine.
Croatian: Prašak sadrži 200 mg stavudina.
English: Methylhydroxybenzoate (E218) Propylhydroxybenzoate (E216) Silicon dioxide
Croatian: Metilhidroksibenzoat (E218) Propilhidroksibenzoat (E216) Silicijev dioksid Simetikon
English: Data on lactic acid in serum were not collected.
Croatian: Nisu prikupljani podaci o laktatnoj kiselini u serumu.
English: Osteonecrosis: cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Croatian: Osteonekroza: prijavljeni su slučajevi osteonekroze, posebno u bolesnika s opće poznatim rizičnim čimbenicima, uznapredovalom HIV bolešću ili dugotrajnom izloženošću kombiniranoj antiretrovirusnoj terapiji (CART).
English: HIV RNA < 50 copies/ml, treatment response, % All patients
Croatian: HIV RNA < 50 kopija/ml, terapijski odgovor (%) Svi bolesnici
English: If you notice any of these symptoms please inform your doctor.
Croatian: Ako opazite bilo koji od tih simptoma, obratite se Vašem liječniku.
English: PHARMACEUTICAL FORM AND CONTENTS 60 hard capsules
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ 60 tvrdih kapsula
English: Four hours after administration, the CSF/plasma ratio was 0.39±0.06.
Croatian: Četiri sata nakon primjene stavudina omjer između koncentracija CSF i plazme iznosio je 0,39±0,06.
English: Pancreatitis was reported in < 1% of patients in combination therapy studies with Zerit.
Croatian: Pankreatitis je bio zabilježen u < 1% bolesnika u ispitivanjima kombinirane terapije s lijekom Zerit.
English: Since stavudine is actively secreted by the renal tubules, interactions with other actively secreted medicinal products are possible, e.g. with trimethoprim.
Croatian: Obzirom da se stavudin aktivno izlučuje putem bubrežnih tubula, moguće su interakcije s ostalim lijekovima koji se također aktivno izlučuju, npr. trimetoprimom.
English: Treatment naive pregnant women were enrolled into the study at gestation week 34-36 and given antiretroviral treatment until delivery.
Croatian: Trudnice koje do tada nisu bile liječene uključene su u ispitivanje u 34-36 tjednu trudnoće i primale su do poroda antiretrovirusnu terapiju.
English: Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported in < 1% of patients taking stavudine in combination with other antiretrovirals (see section 4.4).
Croatian: Slučajevi laktične acidoze, ponekad sa smrtnim ishodom, obično povezane s teškom hepatomegalijom i steatozom jetre, zabilježeni su u < 1% bolesnika koji uzimaju stavudin u kombinaciji s drugim antiretrovirusnim lijekovima (vidjeti dio 4.4).
English: Adolescents, children and infants: total exposure to stavudine was comparable between adolescents, children and infants ≥ 14 days receiving the 2 mg/kg/day dose and adults receiving 1 mg/kg/day.
Croatian: Adolescenti, djeca i dojenčad: ukupna izloženost stavudinu adolescenata, djece i dojenčadi ≥ 14 dana koji su primali dozu od 2 mg/kg/dan bila je usporediva s izloženosti odraslih koji su primali dozu od 1 mg/kg/dan.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Svaki simptom upale treba razmotriti te po potrebi započeti liječenje.
English: Stavudine's influence on the phosphorylation kinetics of nucleoside analogues other than zidovudine has not been investigated.
Croatian: Utjecaj stavudina na kinetiku fosforilacije analoga nukleozida, osim zidovudina, nije ispitivan.
English: Patients should be monitored for symptoms (persistent numbness, tingling or pain in feet/hands) and if present patients should be switched to an alternate treatment regimen (see section 4.2 and Not recommended combinations, below).
Croatian: Bolesnike valja pratiti zbog simptoma (uporna utrnulost, trnci ili bolovi u stopalima/šakama) te ako su ti simptomi prisutni, bolesnike je potrebno prebaciti na drugi režim liječenja (vidjeti dio 4.2 i Kombinacije koje se ne preporučuju).
English: Zerit has been studied in combination with other antiretroviral agents, e.g. didanosine, lamivudine, ritonavir, indinavir, saquinavir, efavirenz, and nelfinavir.
Croatian: Zerit je ispitivan u kombinaciji s drugim antiretrovirusnim lijekovima, npr. didanozinom, lamivudinom, ritonavirom, indinavirom, saquinavirom, efavirenzom i nelfinavirom.
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).
Croatian: Smanjenje osjetljivosti in vitro izrazito je blago, pa su potrebne dvije ili više TAM (općenito M41L i T215Y) da bi se smanjila osjetljivost na stavudin (> 1,5 puta).
English: In addition, rare cases of liver failure/renal failure or fatal hepatitis have been reported.
Croatian: Nadalje, prijavljeni su rijetki slučajevi zatajenja jetre/bubrega ili hepatitisa sa smrtnim ishodom.
English: Treatment with stavudine (Zerit) often causes a loss of fat from legs, arms and face (lipoatrophy).
Croatian: Liječenje stavudinom (Zerit) često uzrokuje gubitak masnog tkiva u nogama, rukama i licu (lipoatrofija).
English: Symptoms may continue or worsen following discontinuation of therapy.
Croatian: Simptomi mogu trajati i nakon prekida terapije ili se mogu i pogoršati.
English: Weight and metabolic parameters: an increase in weight and in levels of blood lipids and glucose may occurr during antiretroviral therapy.
Croatian: Tjelesna težina i metabolički parametri: povećanje tjelesne težine i razina lipida i glukoze u krvi mogu se pojaviti tijekom antiretrovirusne terapije.
English: Hepatitis or liver failure, which was fatal in some cases, has been reported with the use of stavudine (see section 4.4).
Croatian: Hepatitis ili zatajenje jetre, ponekad fatalni, prijavljeni su pri uporabi stavudina (vidjeti dio 4.4).
English: During treatment, other infections linked to a weakened immunity (opportunistic infections) may arise.
Croatian: Tijekom liječenja, uslijed oslabljenog imuniteta, mogu se pojaviti i druge infekcije (oportunističke infekcije).
English: The duration of therapy with Zerit should be limited to the shortest time possible (see section 4.2).
Croatian: Trajanje terapije lijekom Zerit trebalo bi ograničiti na najkraće moguće vrijeme (vidjeti dio 4.2).
English: Adults: the recommended oral dosage is
Croatian: Odrasli: preporučeno oralno doziranje
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%.
Croatian: Periferna neuropatija opažena je u kombiniranim ispitivanjima lijeka Zerit s lamivudinom i efavirenzom; učestalost perifernih neuroloških simptoma bila je 19% (u 6% umjerena do teška), uz učestalost prekida terapije zbog neuropatije od 2%.
English: The mean haemodialysis clearance of stavudine is 120 ml/min.
Croatian: Srednji klirens stavudina hemodijalizom je 120 ml/min.
English: The patients usually experienced resolution of symptoms after dose reduction or interruption of stavudine.
Croatian: Simptomi su obično nestajali nakon smanjenja doze ili prekida primjene stavudina.
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Croatian: Ako primjetite ijedan simptom infekcije ili neke druge simptome kao što su mišićna slabost, slabost koja počinje u šakama i stopalima i širi se po tijelu, osjećaj lupanja srca, nevoljno drhtanje ili hiperaktivnost odmah obavijestite svog liječnika kako biste dobili potrebno liječenje.
English: If you are allergic to stavudine or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični na stavudin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Hepatic impairment: stavudine pharmacokinetics in patients with hepatic impairment were similar to those in patients with normal hepatic function.
Croatian: Oštećenje jetre: farmakokinetika stavudina u bolesnika s oštećenjem jetre bila je slična onoj u bolesnika s normalnom funkcijom jetre.
English: The contribution of this to the total elimination in an overdose situation is unknown.
Croatian: Nije poznato koliko bi ovo moglo doprinijeti ukupnoj eliminaciji lijeka u slučaju predoziranja.
English: For the full list of excipients, see section 6.1.
Croatian: Za cjelovit popis pomoćnih tvari, vidjeti dio 6.1.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Croatian: Ukoliko se u takvih bolesnika jave znaci pogoršanja bolesti jetre, u obzir dolazi privremeni ili trajni prekid liječenja.
English: This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) that may cause allergic reactions (possibly delayed).
Croatian: Ovaj lijek sadrži metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216) koji mogu uzrokovati alergijske reakcije (moguće odgođene).
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.
Croatian: Navedene nuspojave umjerene ili veće težine koje bi mogle biti povezane s režimom liječenja (po mišljenju ispitivača) prijavilo je 467 bolesnika liječenih lijekom Zerit u kombinaciji s lamivudinom i efiravenzom tijekom dva randomizirana klinička ispitivanja i dugotrajnog praćenja (praćenje: medijan 56 tjedana sežući do 119 tjedana).
English: Antiretroviral prophylaxis, the same medications as given to the mother, was given to the new-born infant within 36 hours of delivery and continued for 6 weeks.
Croatian: Novorođenčad je unutar 36 sati po porodu primala antiretrovirusnu profilaksu s istim lijekovima kao i majka, što je nastavljeno kroz 6 tjedana.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 May 1996
Croatian: Datum prvog odobrenja: 08 svibnja 1996
English: Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver side effects and may require blood tests for control of liver function.
Croatian: U bolesnika s kroničnim hepatitisom B ili C koji su liječeni antiretrovirusnim lijekovima povećan je rizik od teških i potencijalno fatalnih jetrenih nuspojava te će možda trebati napraviti krvne pretrage radi kontrole funkcije jetre.
English: No evidence of impaired fertility was seen in rats at high exposure levels (up to 216 times that observed at the recommended clinical dose).
Croatian: Nije se pronašao dokaz da visoka razina izloženosti (do 216 puta veća od one kod preporučenih kliničkih doza) oštećuje plodnost u štakora.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili glukoza-galaktoza malapsorpcijom ne smiju uzimati ovaj lijek.
English: Zerit contains lactose
Croatian: Zerit sadrži laktozu
English: Zerit dosage (according to creatinine clearance)
Croatian: Doza lijeka Zerit (određena prema klirensu kreatinina)
English: No notable differences in the frequency of adverse drug reactions were seen between treatment groups.
Croatian: Nije bilo značajnih razlika u učestalosti nuspojava lijeka između liječenih skupina.
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.
Croatian: Metaboliti uključuju oksidirani stavudin, konjugat stavudina s glukuronidom i njegov oksidirani metabolit, te N-acetilcistein konjugat riboze nakon cijepanja glikozidne veze, što pokazuje da je i timin metabolit stavudina.
English: Your doctor has defined your daily dose based on your weight and individual characteristics.
Croatian: Vaš liječnik je odredio dnevnu dozu za Vas na temelju
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.
Croatian: U bolesnika s kroničnim hepatitisom B ili C, koji su liječeni kombinacijskom antiretrovirusnom terapijom, povećan je rizik od teških i potencijalno fatalnih hepatalnih nuspojava.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Croatian: Glavne prijavljene nuspojave su hematološki poremećaji (anemija, neutropenija) i poremećaji metabolizma (hiperlaktemija, hiperlipazemija).
English: Bone problems
Croatian: Koštani problemi
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.
Croatian: Periferna neuropatija: ukoliko se razviju simptomi periferne neuropatije (obično obilježena trajnom utrnulošću, trncima ili bolovima u stopalima i/ili šakama) (vidjeti dio 4.4.) bolesnika treba prebaciti na alternativni način liječenja, ukoliko je moguće.
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).
Croatian: Poremećaji funkcije mitohondrija: pregled postmarketinške baze podataka o sigurnosti primjene pokazuje da su nuspojave koje upućuju na disfunkciju mitohondrija opisane u populaciji novorođenčadi i dojenčadi koja su bila izložena jednom ili više analoga nukleozida (vidjeti dio 4.4).
English: * Adverse reactions observed post-marketing in association with stavudine-containing antiretroviral treatment ** See Section Description of selected adverse reactions for more details.
Croatian: * nuspojave primijećene u razdoblju nakon stavljanja lijeka u promet koje su bile povezane s antiretrovirusnim terapijskim režimima koji su uključivali stavudin ** Vidjeti dio Opis odabranih nuspojava za detaljnije informacije.
English: Animal data showed embryo-foetal toxicity at very high exposure levels.
Croatian: Kod vrlo visokih razina izloženosti, podaci na životinjama pokazali su embrio-fetalnu toksičnost.
English: In eight patients receiving 40 mg twice daily in the fasted state, steady-state AUC0-12h was 1284±227 ng⋅h/ml (18%) (mean ± SD [% CV]), Cmax was 536±146 ng/ml (27%), and Cmin was 9±8 ng/ml (89%).
Croatian: U osam bolesnika koji su dobivali 40 mg dva puta dnevno natašte, AUC0-12h za stanje dinamičke ravnoteže je iznosio 1284±227 ng·h/ml (18%) (srednja vrijednost ± SD [% CV]), Cmax je bio 536±146 ng/ml (27%), a Cmin 9±8 ng/ml (89%).
English: Data on lactic acid in serum were not collected in this study.
Croatian: U ovom ispitivanju nisu prikupljeni podaci o laktatnoj kiselini u serumu.
English: These TAMs are seen at a similar frequency with stavudine and zidovudine in virological treatment.
Croatian: Ove se TAM vide s istom učestalošću tijekom virološkog liječenja stavudinom i zidovudinom.
English: Do not take Zerit if you are taking didanosine, used to treat HIV infection.
Croatian: Nemojte uzeti Zerit ako uzimate didanozin koji se koristi za liječenje HIV infekcije.
English: What you need to know before you take Zerit
Croatian: Što morate znati prije nego počnete uzimati Zerit
English: Apparent oral clearance was approximately 14 ml/min/kg for infants ages 5 weeks to 15 years, 12 ml/min/kg for infants ages 14 to 28 days, and 5 ml/min/kg for infants on the day of birth.
Croatian: Prividni oralni klirens bio je oko 14 ml/min/kg u bolesnika starih od 5 tjedana do 15 godina, 12 ml/min/kg u novorođenčadi starosti od 14 do 28 dana, i 5 ml/min/kg za novorođenčad na dan rođenja.
English: CD4 Mean Change from Baseline, cells/mm3 All patients
Croatian: CD4 srednja promjena u odnosu na početnu vrijednost, stanica/mm3 Svi bolesnici
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.
Croatian: Stanična DNA-polimeraza γ također je osjetljiva na inhibiciju stavudin trifosfatom, dok su stanične polimeraze α i β inhibirane tek pri koncentracijama koje su 4000 puta, odnosno 40 puta više od onih koje su potrebne za inhibiciju reverzibilne transkriptaze HIV-a.
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).
Croatian: Istodobna primjena s didanozinom zbog mogućih ozbiljnih i /ili po život opasnih događaja, osobito laktacidoze, poremećaja funkcije jetre, pankreatitisa, i periferne neuropatije (vidjeti dijelove 4.4.i 4.5.).