FrancophonIA/ELRC3.0 huggingface dataset:
English: The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Croatian: Oštećenje mišića, omekšanje kostiju (uz bol u kostima i ponekad s posljedičnim prijelomom kostiju), bol u mišićima, slabost mišića i smanjenje razine kalija ili fosfata u krvi mogu nastupiti zbog oštećenja stanica bubrežnih kanalića.
English: Following the first dose of tenofovir disoproxil in fed patients, the median Cmax in serum ranged from 213 to 375 ng/ml.
Croatian: Nakon prve doze tenofovirdizoproksila primijenjene nahranjenim bolesnicima, medijan Cmax u serumu kretao se u rasponu od 213 do 375 ng/ml.
English: Based on these data, it is unlikely that clinically significant interactions involving tenofovir disoproxil and medicinal products metabolised by CYP450 would occur.
Croatian: Na temelju tih podataka ne postoji vjerojatnost da će nastupiti klinički značajne interakcije koje uključuju tenofovirdizoproksil i lijekove koji se metaboliziraju pomoću CYP450.
English: NA = Not Applicable a BMD Z-scores only available for a limited set of subjects with matched reference data b Secondary endpoint through week 48
Croatian: N/P = nije primjenjivo a BMD Z-rezultati dostupni su samo za ograničeni skup ispitanika s odgovarajućim referentnim podacima b Sekundarna mjera ishoda do 48. tjedna
English: Study 174-0102 (HBeAg negative)
Croatian: Ispitivanje 174-0102 (HBeAg-negativni)
English: Open date: [outer packaging only]
Croatian: Datum otvaranja: [samo vanjsko pakiranje]
English: NA = Not Applicable a BMD Z-scores not adjusted for height and weight b Primary safety endpoint through week 72
Croatian: NP = Nije primjenjivo a BMD Z-rezultat nije prilagođen za tjelesnu visinu i težinu b Primarne sigurnosne mjere ishoda kroz 72 tjedna
English: In clinical trials of HBV infected patients, the most frequently occurring adverse reaction to tenofovir disoproxil was nausea (5.4%).
Croatian: U kliničkim ispitivanjima s bolesnicima zaraženima HBV-om, najčešće zabilježena nuspojava tenofovirdizoproksila bila je mučnina (5,4%).
English: If you miss a dose of Tenofovir disoproxil Zentiva, work out how long since you should have taken it.
Croatian: Ako propustite dozu lijeka Tenofovir disoproxil Zentiva, izračunajte koliko je proteklo od vremena kad ste je trebali uzeti.
English: Tenofovir disoproxil Zentiva is not suitable for the following groups:
Croatian: Tenofovir disoproxil Zentiva nije pogodan za sljedeće skupine:
English: Romania or
Croatian: Rumunjska ili
English: Lipid disorders should be managed as clinically appropriate.
Croatian: Poremećaje lipida potrebno je prikladno klinički liječiti
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin
Croatian: Učinci na koncentracije lijeka Srednja vrijednost postotka promjene AUC, Cmax, Cmin
English: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 ml/min/1.73 m2.
Croatian: Procijenjene vrijednosti brzine glomerularne filtracije (GFR) u sedam bolesnika iznosile su između 70 i 90 ml/min/1,73 m2.
English: What you need to know before you take Tenofovir disoproxil Zentiva
Croatian: Što morate znati prije nego počnete uzimati Tenofovir disoproxil Zentiva
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
Croatian: Serumske razine ALT i HBV DNK moraju se redovito nadzirati nakon prestanka liječenja, kako bi se uočio svaki kasni virološki relaps.
English: Baseline genotypic analysis of HIV isolates from 253 patients revealed that 94% of patients had HIV-1 resistance mutations associated with nucleoside reverse transcriptase inhibitors, 58% had mutations associated with protease inhibitors and 48% had mutations associated with non-nucleoside reverse transcriptase inhibitors.
Croatian: Početna genotipska analiza izolata HIV-a u 253 bolesnika otkrila je da je 94% bolesnika imalo HIV-1 mutacije za rezistenciju povezane s nukleozidnim inhibitorima reverzne transkriptaze, 58% je imalo mutacije povezane s inhibitorima proteaze, a 48% je imalo mutacije povezane s nenukleozidnim inhibitorima reverzne transkriptaze.
English: The pharmacokinetics of tenofovir were independent of tenofovir disoproxil dose over the dose range 75 to 600 mg and were not affected by repeated dosing at any dose level.
Croatian: Farmakokinetika tenofovira je nezavisna od doze tenofovirdizoproksila u rasponu doza od 75 do 600 mg i nije pod utjecajem ponovljenih doza bilo koje jačine.
English: The dosing recommendations in patients with renal impairment, with increased dosing interval, are expected to result in higher peak plasma concentrations and lower Cmin levels in patients with renal impairment compared with patients with normal renal function.
Croatian: Očekuje se da će preporukedoziranja u bolesnika s oštećenjem funkcije bubrega, uz povećane intervale doziranja, rezultirati višim vršnim plazmatskim koncentracijama i nižim razinama Cmin u bolesnika s oštećenjem funkcije bubrega u usporedbi s bolesnicima s normalnom funkcijom bubrega.
English: HBV DNA n (%) < 400 copies/ml n (%)
Croatian: HBV DNK n (%) < 400 kopija/ml n (%)
English: Co-infection with hepatitis C or D: There are no data on the efficacy of tenofovir in patients co-infected with hepatitis C or D virus.
Croatian: Istovremena infekcija virusom hepatitisa C ili D: Ne postoje podataci o djelotvornosti tenofovira u bolesnika koji su istovremeno inficirani virusom hepatitisa C ili D.
English: If you feel dizzy while taking Tenofovir disoproxil Zentiva, do not drive or ride a bicycle and do not use any tools or machines.
Croatian: Ako tijekom uzimanja lijeka Tenofovir disoproxil Zentiva imate omaglicu, nemojte upravljati vozilom, voziti bicikl niti raditi s alatima ili strojevima.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Croatian: Ako u tih bolesnika nastupe znakovi pogoršanja bolesti jetre, mora se razmisliti o privremenom ili trajnom prekidu liječenja.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil in randomised controlled clinical trials and the expanded access program (n = 7,319).
Croatian: Kategorija učestalosti procijenjena je pomoću statističkog proračuna na temelju ukupnog broja bolesnika izloženih tenofovirdizoproksilu u randomiziranim kontroliranim kliničkim ispitivanjima i programu proširenog pristupa liječenju (n = 7319).
English: After 72 weeks of blinded randomized treatment, each subject could switch to open-label tenofovir disoproxil treatment up to week 192.
Croatian: Nakon 72 tjedna slijepog, randomiziranog liječenja, svaki se ispitanik mogao prebaciti na otvoreno liječenje tenofovirdizoproksilom do 192. tjedna.
English: The use of tenofovir disoproxil may be considered during pregnancy, if necessary.
Croatian: Stoga se za vrijeme trudnoće može razmotriti primjena tenofovirdizoproksila ako je potrebno.
English: Oblong-shaped, light blue colored film-coated tablets with dimensions approx. 17.2 x 8.2 mm.
Croatian: Ovalna, svijetlo plava, filmom obložena tableta, dimenzija približno 17,2 mm x 8,2 mm.
English: However, administration of tenofovir disoproxil with a light meal did not have a significant effect on the pharmacokinetics of tenofovir.
Croatian: Međutim, primjena tenofovirdizoproksila s laganim obrokom nije imala značajan učinak na farmakokinetiku tenofovira.
English: 240k 288n 384p
Croatian: 192i 240k 288n 384p
English: Resistance: Strains of HIV-1 with reduced susceptibility to tenofovir and a K65R mutation in reverse transcriptase have been selected in vitro and in some patients (see Clinical efficacy and safety).
Croatian: Rezistencija: Sojevi HIV-1 smanjene osjetljivosti na tenofovir i s mutacijom reverzne transkriptaze K65R izdvojeni su in vitro i u nekih bolesnika (vidjeti odlomak Klinička djelotvornost i sigurnost).
English: If you think that you may have any of these serious side effects, talk to your doctor.
Croatian: Ako mislite da možda imate neku od ovih ozbiljnih nuspojava, obavijestite svog liječnika.
English: Both treatments produced similar results with regard to histological response (defined as Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis) at week 48 (see Table 3 below).
Croatian: Oba liječenja imaju slične rezultate s obzirom na histološki odgovor (definiran kao poboljšanje rezultata na Knodellovoj ljestvici nekroinflamatorne aktivnosti za najmanje dva boda bez pogoršanja na Knodellovoj ljestvici fibroze) u 48. tjednu (vidjeti tablicu 3 niže).
English: Serum ALT should be persistently elevated for at least 6 months prior to treatment of paediatric patients with compensated liver disease due to HBeAg positive chronic hepatitis B; and for at least 12 months in patients with HBeAg negative disease.
Croatian: Serumski ALT treba biti kontinuirano povišen najmanje 6 mjeseci prije liječenja pedijatrijskih bolesnika s kompenziranom bolešću jetre uslijed HBeAg pozitivnog kroničnog hepatitisa B te najmanje 12 mjeseci u bolesnika s HBeAg negativnom bolešću.
English: Administration of tenofovir disoproxil with a high fat meal enhanced the oral bioavailability, with an increase in tenofovir AUC by approximately 40% and Cmax by approximately 14%.
Croatian: Primjena tenofovirdizoproksila s obrokom bogatim mastima povećala je oralnu bioraspoloživost, kod čega se AUC vrijednost tenofovira povećala za približno 40%, a Cmax za približno 14%.
English: Tenofovir shows activity in vitro against HIV-2, with an EC50 of 4.9 µmol/l in MT-4 cells.
Croatian: Tenofovir pokazuje aktivnost in vitro protiv virusa HIV-2, uz EC50 od 4,9 µmol/l u MT-4 stanicama.
English: This is because the active substance in this medicine passes into human breast milk.
Croatian: Djelatna tvar iz ovog lijeka prelaze u majčino mlijeko.
English: Tenofovir is principally eliminated via the kidney.
Croatian: Tenofovir se primarno eliminira putem bubrega.
English: The bone toxicity in young adult rats and dogs occurred at exposures ≥ 5-fold the exposure in paediatric or adult patients; bone toxicity occurred in juvenile infected monkeys at very high exposures following subcutaneous dosing (≥ 40-fold the exposure in patients).
Croatian: U mladih odraslih štakora i pasa toksičnost za kosti pokazala se pri izloženosti ≥ 5 puta većoj od izloženosti kod pedijatrijskih ili odraslih bolesnika; toksičnost za kosti pojavila se u mladih zaraženih majmuna pri vrlo visokim izloženostima nakon supkutanog doziranja (za ≥ 40 puta veća izloženost nego u bolesnika).
English: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage in HIV patients when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Croatian: Postoje izvješća o visokoj stopi virološkog neuspjeha i pojavi rezistencije u početnom stadiju u bolesnika zaraženih HIV-om kada se tenofovirdizoproksil kombinirao s lamivudinom i abakavirom, kao i s lamivudinom i didanozinom u režimu liječenja jedanput na dan.
English: Study 174-0103 (HBeAg positive)
Croatian: Ispitivanje 174-0103 (HBeAg-pozitivni)
English: • If you are a woman with HIV or HBV do not breast-feed, to avoid passing the virus to the baby in breast milk.
Croatian: • Ako ste žena koja je zaražena HIV-om ili HBV-om, nemojte dojiti kako biste izbjegli mogućnost da virus u majčinom mlijeku prijeđe virus na dojenče.
English: Among them, 3 patients experienced a clinically meaningful decline in estimated GFR which improved after discontinuation of tenofovir disoproxil.
Croatian: Među njima su 3 bolesnika imala klinički značajan pad procijenjenog GFR-a koji se poboljšao nakon prekida primjene tenofovirdizoproksila.
English: Tenofovir disoproxil at a concentration of 100 µmol/l had no effect on any of the CYP450 isoforms, except CYP1A1/2, where a small (6%) but statistically significant reduction in metabolism of CYP1A1/2 substrate was observed.
Croatian: U koncentraciji od 100 µmol/l, tenofovirdizoproksil nije imao učinka ni na koji od izooblika enzima CYP450, osim na CYP1A1/2, gdje je zapaženo malo (6%), ali statistički značajno smanjenje metabolizma supstrata CYP1A1/2.
English: The active substance is tenofovir.
Croatian: - Djelatna tvar je tenofovir.
English: However, it should be noted that increases of ALT can be part of HBV clearance during therapy with tenofovir, see above Exacerbations of hepatitis.
Croatian: Međutim, treba imati na umu da porast razine ALT-a može biti dio klirensa HBV-a tijekom terapije tenofovirom, vidjeti gornji tekst Egzacerbacija hepatitisa.
English: Renal clearance has been estimated to be approximately 160 ml/h/kg (approximately 210 ml/min), which is in excess of the glomerular filtration rate.
Croatian: Bubrežni klirens je procijenjen da iznosi otprilike 160 ml/h/kg (približno 210 ml/min), što prelazi brzinu glomerularne filtracije.
English: Patients must be advised that tenofovir disoproxil has not been proven to prevent the risk of transmission of HBV to others through sexual contact or contamination with blood.
Croatian: Bolesnici moraju biti podučeni o tome da nije dokazano da tenofovirdizoproksil sprječava rizik od prijenosa HBV-a na druge osobe spolnim kontaktom ili putem krvi.
English: One patient in the tenofovir disoproxil arm developed the K70E substitution in the virus.
Croatian: Jedan bolesnik u skupini koja je primala tenofovirdizoproksil razvio je K70E supstituciju u virusu.
English: This medicine is not a cure for HIV infection.
Croatian: Ovaj lijek neće izliječiti infekciju virsuom HIV -a.
English: The difference in the proportion of patients who maintained < 400 copies/ml at week 48 was mainly influenced by the higher number of discontinuations in the tenofovir disoproxil treatment group.
Croatian: Na razliku u udjelu bolesnika u kojih se zadržalo < 400 kopija/ml u 48. tjednu uglavnom je utjecao veći broj prekida liječenja u skupini koja je primala tenofovirdizoproksil.
English: In exceptional circumstances in patients having particular difficulty in swallowing, Tenofovir disoproxil Zentiva can be administered following disintegration of the tablet in at least 100 ml of water, orange juice or grape juice.
Croatian: Za bolesnike koji otežanu gutaju filmom obložene tablete, Tenofovir disoproxil Zentiva može se primijeniti nakon otapanja tablete u najmanje 100 ml vode, soka od naranče ili soka od grožđa.
English: Animal studies do not indicate harmful effects of tenofovir disoproxil on fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na štetan učinak tenofovirdizoproksila na plodnost.
English: • HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects
Croatian: • adolescente zaražene virusom HIV-1, u dobi od 12 do manje od 18 godina i imaju tjelesnu težinu od najmanje 35 kg i već su bili liječini drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistancije ili su prouzročili nuspojave
English: Patients at risk of renal impairment (such as patients with baseline renal risk factors, advanced HIV disease, or patients receiving concomitant nephrotoxic medications) are at increased risk of experiencing incomplete recovery of renal function despite tenofovir disoproxil discontinuation (see section 4.4).
Croatian: Bolesnici s rizikom od oštećenja funkcije bubrega (kao što su bolesnici s početnim bubrežnim čimbenicima rizika, uznapredovalom HIV bolešću ili bolesnici koji istovremeno primaju nefrotoksične lijekove) pod povećanim su rizikom od nepotpunog oporavka funkcije bubrega usprkos prekidu terapije tenofovirdizoproksilom (vidjeti dio 4.4).
English: Possible serious side effects: tell your doctor immediately Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 people) but serious side effect that can be fatal.
Croatian: Laktacidoza (prekomjerna količina mliječne kiseline u krvi) je rijetka (može se javiti u do 1 na 1000 osoba), ali ozbiljna nuspojava koja može imati smrtni ishod.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1127/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1127/001
English: There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was coadministered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ethinyl oestradiol.
Croatian: Nema klinički značajnih farmakokinetičkih interakcija kada se tenofovirdizoproksil primjenjuje istovremeno s emtricitabinom, lamivudinom, indinavirom, efavirenzom, nelfinavirom, sakvinavirom (pojačanim ritonavirom), metadonom, ribavirinom, rifampicinom, takrolimusom ili hormonskim kontraceptivom norgestimatom/etinilestradiolom.
English: 2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical trials or the tenofovir disoproxil expanded access program.
Croatian: 2 Ova nuspojava prepoznata je tijekom praćenja lijeka nakon stavljanja u promet, ali nije opažena u randomiziranim kliničkim kontroliranim ispitivanjima tenofovirdizoproksila ili programu proširenog pristupa terapiji.
English: HIV-1: Approximately one third of patients can be expected to experience adverse reactions following treatment with tenofovir disoproxil in combination with other antiretroviral agents.
Croatian: HIV-1: Može se očekivati da će približno jedna trećina bolesnika razviti nuspojave nakon liječenja tenofovirdizoproksilom u kombinaciji s drugim antiretrovirusnim lijekovima.
English: At week 48, six adolescents in the tenofovir disoproxil group and one adolescent in the placebo group had significant lumbar spine BMD loss (defined as > 4% loss).
Croatian: U 48. tjednu 6 adolescenata u skupini koja je primala tenofovirdizoproksil i jedan adolescent iz skupine koja je primala placebo imali su značajan gubitak BMD-a u lumbalnoj kralježnici (definiran kao gubitak > 4%).
English: The bottle contains 30 film-coated tablets and a silica gel desiccant (in a container).
Croatian: Boca sadrži 30 filmom obloženih tableta i silikagel kao sredstvo za sušenje (u spremniku).
English: Haemodialysis patients: 245 mg tenofovir disoproxil may be administered every 7 days following completion of a haemodialysis session*.
Croatian: Bolesnici na hemodijalizi: 245 mg tenofovirdizoproksila može se primijeniti svakih 7 dana nakon završetka postupka hemodijalize*.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza oznake „Rok valjanosti”.
English: What Tenofovir disoproxil Zentiva is and what it is used for
Croatian: Što je Tenofovir disoproxil Zentiva i za što se koristi
English: ALT elevations had a median time to onset of 8 weeks, resolved with continued treatment, and, in a majority of cases, were associated with a ≥ 2 log10 copies/ml reduction in viral load that preceded or coincided with the ALT elevation.
Croatian: Povišena razina ALT-a nastala bi nakon medijana razdoblja od 8 tjedana, povukla se s nastavkom liječenja i u većini slučajeva bila povezana sa smanjenjem virusnog opterećenja od ≥ 2 log10 kopija/ml koje je prethodilo ili se podudaralo s povišenjem razine ALT-a.
English: - decompensated liver disease (see sections 4.4, 4.8 and 5.1).
Croatian: dekompenziranom bolešću jetre (vidjeti dijelove 4.4, 4.8 i 5.1).
English: Flares after treatment discontinuation: Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy.
Croatian: Pogoršanje bolesti nakon prekida liječenja: Akutna egzacerbacija hepatitisa također je zabilježena u bolesnika koji su prekinuli terapiju hepatitisa B.
English: Film-coating: lactose monohydrate, hypromellose, titanium dioxide, triacetin, indigo carmine aluminum lake.
Croatian: Film ovojnica: laktoza hidrat, hipromeloza, titanijev dioksid, triacetin, boja indigo karmin aluminium lake.
English: In adult patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended.
Croatian: U odraslih bolesnika s dekompenziranom bolešću jetre ili cirozom ne preporučuje se prekid liječenja.
English: If you are older than this and are prescribed Tenofovir disoproxil Zentiva, your doctor will monitor you carefully.
Croatian: Imate li više od 65 godina, a propisali su Vam lijek Tenofovir disoproxil Zentiva, liječnik će Vas pažljivo pratiti.
English: Of the 94 patients with cirrhosis at baseline (Ishak fibrosis score 5-6), 26% (24) experienced no change in Ishak fibrosis score and 72% (68) experienced regression of cirrhosis by week 240 with a reduction in Ishak fibrosis score of at least 2 points.
Croatian: Od 94 bolesnika s cirozom na početku (5 - 6 bodova na Ishakovoj ljestvici fibroze), 26% (24) nije imalo nikakve promjene u rezultatu na Ishakovoj ljestvici fibroze, a 72% (68) jje imalo regresiju ciroze do 240. tjedna i snižen rezultat na Ishakovoj ljestvici fibroze za najmanje 2 boda.
English: (4 subjects)
Croatian: (4 ispitanika)
English: The results indicate that patients whose HIV expressed 3 or more thymidine-analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced response to tenofovir disoproxil 245 mg therapy.
Croatian: Rezultati pokazuju da su bolesnici čiji je HIV izražavao 3 ili više mutacija povezanih s analogom timidina (TAM) koje su uključivale mutaciju reverzne transkriptaze M41L ili L210W pokazali smanjeni odgovor na terapiju tenofovirdizoproksilom u dozi od 245 mg.
English: The adverse reactions observed with continued treatment for 384 weeks were consistent with the safety profile of tenofovir disoproxil.
Croatian: Nuspojave primijećene tijekom nastavka liječenja do 384. tjedna bile su u skladu sa sigurnosnim profilom tenofovirdizoproksila.
English: Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.
Croatian: Tenofovir difosfat inhibira reverznu transkriptazu virusa HIV-1 i polimerazu virusa HBV izravno se natječući za vezno mjesto s prirodnim deoksiribonukleotidnim supstratom i, nakon ugradnje u DNK, završetkom DNK lanca.
English: diarrhoea, vomiting, nausea
Croatian: proljev, povraćanje, mučnina
English: • Not for HIV-1 infected children under 12 years of age.
Croatian: • nije pogodan za djecu zaraženu virusom HIV-1 mlađu od 12 godina
English: The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the emergence of resistant hepatitis B virus and the uncertainties as regards the long term impact of bone and renal toxicity (see section 4.4).
Croatian: Potrebno je razmotriti koristi dugoročne virusne supresije uz nastavak liječenja u nasuprot riziku od produljenog liječenja, uključujući pojavu rezistentnog virusa hepatitisa B te nesigurnosti u pogledu dugoročnog učinka koštane i bubrežne toksičnosti (vidjeti dio 4.4).
English: • That Tenofovir disoproxil Zentiva may cause a reduction in BMD and the effects of Tenofovir disoproxil Zentiva associated changes in BMD on long term bone health and future fracture risk are currently unknown in adolescent patients
Croatian: • Da Tenofovir disoproxil Zentiva može uzrokovati smanjenje mineralne gustoće kostiju, a učinci promjene mineralne gustoće kostiju povezani s lijekom Tenofovir disoproxil Zentiva na dugoročno zdravlje kostiju i rizik od budućih prijeloma u adolescentnih bolesnika za sada nisu poznati.
English: - evidence of lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1).
Croatian: dokazom virusa hepatitisa B rezistentnog na lamivudin (vidjeti dijelove 4.8 i 5.1)