FrancophonIA/ELRC3.0 huggingface dataset:
English: • Not for HBV infected children under 12 years of age.
Croatian: • nisu za djecu zaraženu virusom HBV-a mlađu od 12 godina.
English: High density polyethylene (HDPE) bottle with polypropylene (PP) child resistant closure with wad containing aluminium induction sealing liner and desiccant (silica gel), available in the following pack sizes: 30 film-coated tablets and multipacks containing 90 (3 packs of 30) film-coated tablets.
Croatian: Boca od polietilena visoke gustoće (HDPE) s polipropilenskim (PP) sigurnosnim zatvaračem za djecu, zatvorena aluminijskom zaštitnom folijom i s umetnutim desikantom (silika-gel) dostupna u sljedećim veličinama pakiranja: 30 filmom obloženih tableta i multipakiranja koja sadrže 90 (3 paketa od 30) filmom obloženih tableta.
English: 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: 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: Your doctor may order blood tests during treatment to monitor how your kidneys work.
Croatian: Liječnik može zatražiti krvne pretrage i tijekom liječenja u cilju praćenja rada Vaših bubrega.
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 10 or 30 film coated tablets.
Croatian: Blisteri od OPA/aluminij/PE/desikant/PE-aluminijske folije koji sadrže 10 ili 30 filmom obloženih tableta.
English: If you take more Tenofovir disoproxil Mylan than you should If you accidentally take too many Tenofovir disoproxil Mylan tablets, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Croatian: Ako slučajno uzmete previše Tenofovir disoproxil Mylan tableta, možete imati povećani rizik od mogućih nuspojava ovog lijeka (pogledajte dio 4 Moguće nuspojave).
English: Lumbar spine BMD at least 6% decrease b NA
Croatian: Smanjenje BMD-a lumbalne kralježnic e za najmanje 6% b
English: If you think that you may have any of these serious side effects, talk to your doctor.
Croatian: Ako mislite da imate bilo koju od ovih ozbiljnih nuspojava, obavijestite svog liječnika.
English: Two subjects randomised to tenofovir disoproxil experienced HBsAg loss by Week 240, but not seroconversion to anti-HBs.
Croatian: Dva ispitanika randomizirana za tenofovirdizoproksil imala su nestanak HbsAg do 240. tjedna, ali ne i serokonverziju na anti-HBs.
English: Eight (2%) tenofovir disoproxil 245 mg treated patients developed the K65R mutation within the first 48 weeks.
Croatian: Osam (2%) bolesnika liječenih tenofovirdizoproksilom u dozi od 245 mg razvilo je mutaciju K65R unutar prvih 48 tjedana.
English: There are limited data on the safety and efficacy of tenofovir disoproxil in HBV infected patients with decompensated liver disease and who have a Child-Pugh-Turcotte (CPT) score > 9.
Croatian: Postoje ograničeni podaci o sigurnosti i djelotvornosti tenofovirdizoproksila u bolesnika s infekcijom HBV-om i dekompenziranom bolešću jetre te koji imaju Child-Pugh-Turcotte (CPT) rezultat veći od 9.
English: HIV antiviral activity in vitro: The concentration of tenofovir required for 50% inhibition (EC50) of the wild-type laboratory strain HIV-1IIIB is 1-6 µmol/l in lymphoid cell lines and 1.1 µmol/l against primary HIV-1 subtype B isolates in PBMCs.
Croatian: Antivirusna aktivnost na HIV in vitro: Koncentracija tenofovira koja je potrebna za 50%-tnu inhibiciju (EC50) laboratorijskog soja divljeg tipa HIV-1IIIB jest 1-6 µmol/l u limfoidnim staničnim linijama i 1,1 µmol/l za primarne izolate HIV-1 podtipa B u MSPK.
English: Subjects must have been naïve to tenofovir disoproxil, but could have received interferon based regimens (> 6 months prior to screening) or any other non-tenofovir disoproxil containing oral anti-HBV nucleoside/nucleotide therapy (> 16 weeks prior to screening).
Croatian: Ispitanici nisu smjeli biti prethodno liječeni tenofovirdizoproksilom, ali su mogli primati režime na bazi interferona (> 6 mjeseci prije probira) ili neku drugu peroralnu terapiju nukleozidima/nukleotidima za HBV koja nije sadržavala tenofovirdizoproksil (> 16 tjedana prije probira).
English: • softening of the bones (with bone pain and sometimes resulting in fractures), which may occur due to damage to kidney tubule cells
Croatian: • omekšanje kostiju (uz bol u kostima i ponekad posljedičnim prijelomom kostiju) do čega može doći zbog oštećenja stanica bubrežnih tubula.
English: Forty-three percent of patients had baseline viral loads > 100,000 copies/ml and 39% had CD4 cell counts < 200 cells/ml.
Croatian: Četrdeset i tri posto bolesnika imalo je početno virusno opterećenje > 100 000 kopija/ml, a 39% imalo je broj CD4 stanica < 200 stanica/ml.
English: Experience in patients with compensated liver disease at 48 weeks (studies GS-US-174-0102 and GSUS-174-0103)
Croatian: Iskustva kod bolesnika s kompenziranom bolešću jetre tijekom 48 tjedana (ispitivanja GS-US-174-0102 i GS-US-174-0103)
English: • That there is an increased risk of renal disease in HIV and HBV infected patients associated with tenofovir disoproxil-containing products such as Tenofovir disoproxil Mylan
Croatian: • Da u bolesnika zaraženih HIV-om i HBV-om postoji povećan rizik od bubrežne bolesti povezan s lijekovima koji sadrže tenofovirdizoproksil, kao što je Tenofovir disoproxil Mylan
English: As tenofovir disoproxil may cause renal damage monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
Croatian: Pošto tenofovirdizoproksil može prouzročiti oštećenje bubrega, preporučuje se praćenje funkcije bubrega (vidjeti dijelove 4.4 i 4.8 Sažetak profila sigurnosti primjene).
English: Refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.
Croatian: Pročitajte upute o drugim antiretrovirusnim lijekovima, koje su namijenjene bolesniku i koje daju smjernice o načinu uzimanja tih lijekova.
English: If Tenofovir disoproxil Mylan is used with nephrotoxic medicinal products, renal function should be closely monitored according to the recommended schedule
Croatian: Ako se Tenofovir disoproxil Mylan primjenjuje s nefrotoksičnim lijekovima, bubrežnu funkciju treba pažljivo nadzirati prema preporučenom rasporedu.
English: Moderate renal impairment (creatinine clearance 30-49 ml/min) Since administration of a lower dose with the 245 mg tablet is not possible, prolonged dose intervals using the 245 mg film-coated tablets may be used.
Croatian: Umjereno oštećenje funkcije bubrega (klirens kreatinina 30-49 ml/min) Budući da primjena niže doze s tabletama od 245 mg nije moguća, mogu se primjenjivati produženi intervali između doza filmom obloženih tableta od 245 mg.
English: As Tenofovir disoproxil Mylan is available only as 245 mg film-coated tablets, it is not suitable for the use in paediatric patients aged 2 to < 12 years.
Croatian: Budući da je Tenofovir disoproxil Mylan dostupan samo u obliku filmom obloženih tableta od 245 mg, nije prikladan za pimjenu u pedijatrijskih bolesnika u dobi od 2 do < 12 godina.
English: If a patient misses a dose of tenofovir disoproxil by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
Croatian: Ako bolesnik propusti uzeti dozu tenofovirdizoproksila a prošlo je više od 12 sati i već je blizu vrijeme za uzimanje sljedeće doze, bolesnik ne treba uzeti propuštenu dozu nego jednostavno nastaviti uzimati lijek prema svom uobičajenom rasporedu.
English: Studies have established the pathway of active tubular secretion of tenofovir to be influx into proximal tubule cell by the human organic anion transporters (hOAT) 1 and 3 and efflux into the urine by the multidrug resistant protein 4 (MRP 4).
Croatian: Istraživanja su utvrdila da put aktivnog tubularnog izlučivanja tenofovira utiče u proksimalne tubularne stanice putem humanog organskog transportnog aniona (hOAT) 1 i 3 i izvire u urin putem proteina 4 (MRP 4) višestruko rezistentnim na lijekove.
English: You do not need to take another tablet if you were sick more than 1 hour after taking Tenofovir disoproxil Mylan
Croatian: Drugu tabletu ne trebate uzimati ako ste povraćali nakon što je prošlo više od 1 sata po uzimanju lijeka Tenofovir disoproxil Mylan.
English: The active substance tenofovir disoproxil and its main transformation products are persistent in the environment.
Croatian: Djelatna tvar tenofovirdizoproksil i njegovi glavni transformacijski produkti nisu razgradivi u okolišu.
English: For treatment of HIV-1 infection and chronic hepatitis B in adults for whom a solid dosage form is not appropriate, other suitable formulations may be checked for their availability.
Croatian: Za liječenje infekcije virusom HIV 1 i kroničnog hepatitisa B u odraslih u kojih primjena doza u krutom obliku nije prikladna, moguće je provjeriti dostupnost drugih prikladnih formulacija.
English: Studies conducted with other medicinal products There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered 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: The HIV and HBV patients aged 12 to < 18 years educational brochures should contain the following key messages:
Croatian: Edukacijske brošure za bolesnike od 12 do ˂ 18 godina s HIV-om i HBV-om trebaju sadržavati sljedeće ključne poruke:
English: Microcrystalline cellulose Lactose monohydrate Hydroxypropylcellulose, low substituted Silica, colloidal anhydrous Magnesium stearate
Croatian: Jezgra tablete mikrokristalična celuloza laktoza hidrat hidroksipropilceluloza, djelomično supstituirana silicijev dioksid, koloidni bezvodni magnezijev stearat
English: Administration of tenofovir disoproxil 33 mg/g granules to provide a reduced daily dose of tenofovir disoproxil is recommended for adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients.
Croatian: Primjena tenofovirdizoproksila 33 mg/g granula za omogućavanje snižene dnevne doze tenofovirdizoproksila preporučuje se za odrasle bolesnike s klirensom kreatinina < 50 ml/min, uključujući bolesnike na hemodijalizi.
English: Tenofovir disoproxil Mylan tablets should be taken once daily, orally with food.
Croatian: Tablete Tenofovir disoproxil Mylan potrebno je uzimati peroralno s hranom, jedanput na dan.
English: • compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis (see sections 4.4, 4.8 and 5.1).
Croatian: • kompenziranom bolešću jetre i dokazom imunološki aktivne bolesti, tj. aktivnom replikacijom virusa, trajno povišenim razinama ALT-a u serumu i histološki dokazanom aktivnom upalom i/ili fibrozom (vidjeti dijelove 4.4, 4.8 i 5.1).
English: Tell your doctor before taking Tenofovir disoproxil Mylan if you cannot tolerate lactose or if you have an intolerance to any other sugars.
Croatian: Obavijestite liječnika prije nego što počnete uzimati Tenofovir disoproxil Mylan ako ne podnosite laktozu ili imate poremećaj nepodnošenja nekih šećera.
English: Safety and efficacy data are very limited in liver transplant patients.
Croatian: Podaci o sigurnosti i djelotvornosti u bolesnika s transplantiranom jetrom vrlo su ograničeni.
English: • HBV infected adolescents aged 12 to less than 18 years who weigh at least 35 kg.
Croatian: • adolescente zaražene virusom HBV-a koji su u dobi od 12 do manje od 18 godina i imaju tjelesnu težinu od najmanje 35 kg.
English: Cumulatively, there were 4 patients who experienced a viremic episode (HBV DNA>400 copies/ml) at their last timepoint on tenofovir disoproxil.
Croatian: Kumulativno, 4 bolesnika na tenofovirdizoproksilu imala su viremijsku epizodu (HBV DNK > 400 kopija/ml) u posljednjoj vremenskoj točki.
English: In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis.
Croatian: U nekih se bolesnika s uznapredovalom bolešću jetre ili cirozom jetre ne preporučuje prekid liječenja, jer to može dovesti do pogoršanja hepatitisa.
English: Chronic hepatitis B: In study GS-US-174-0115, 106 HBeAg negative and HBeAg positive patients aged 12 to < 18 years with chronic HBV infection [HBV DNA ≥ 10
Croatian: Kronični hepatitis B: U ispitivanju GS-US-174-0115, 106 HBeAg-negativnih i HBeAg-pozitivnih bolesnika u dobi od 12 do < 18 godina s kroničnom HBV-infekcijom [HBV DNK ≥ 10
English: Median change from baseline HBV DNA merely reflects the difference between baseline HBV DNA and the limit of detection (LOD) of the assay.
Croatian: c Medijan promjene od početnih vrijednosti HBV DNK jedva da odražava razliku između početne razine HBV DNK i granice detekcije (LOD) testa.
English: Since tenofovir is primarily eliminated by the kidneys, co-administration of tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion via transport proteins hOAT 1, hOAT 3 or MRP 4 (e.g. cidofovir) may increase serum concentrations of tenofovir and/or the co-administered medicinal products.
Croatian: Kako se i tenofovir primarno eliminira putem bubrega, istovremena primjena tenofovirdizoproksila i lijekova koji smanjuju funkciju bubrega ili se natječu za aktivnu tubularnu sekreciju preko transportnih proteina hOAT 1, hOAT 3 ili MRP 4 (npr. cidofovir) može povećati serumske koncentracije tenofovira i/ili istovremeno primijenjenih lijekova.
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: Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).
Croatian: Poteškoće s kostima (koje katkada završe prijelomima) mogu se također javiti zbog oštećenja stanica bubrežnih tubula (pogledajte dio 4, Moguće nuspojave).
English: After oral administration of tenofovir disoproxil, tenofovir is distributed to most tissues with the highest concentrations occurring in the kidney, liver and the intestinal contents (preclinical studies).
Croatian: Nakon peroralne primjene tenofovirdizoproksila tenofovir se raspodjeljuje u većinu tkiva, kod čega su najviše koncentracije u bubregu, jetri i sadržaju crijeva (neklinička ispitivanja).
English: For treatment of HIV-1 infection and chronic hepatitis B in adolescents aged 12 to <18 years for whom a solid dosage form is not appropriate, other suitable formulations may be checked for their availability.
Croatian: Za liječenje infekcije virusom HIV- 1 i kroničnog hepatitisa B u adolescenata u dobi od 12 do < 18 godina u kojih primjena doza u krutom obliku nije prikladna, moguće je provjeriti dostupnost drugih prikladnih formulacija.
English: • It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.
Croatian: • Također je važno obavijestiti liječnika ako uzimate ledipasvir/sofosbuvir, sofosbuvir/velpatasvir ili sofosbuvir/velpatasvir/voksilaprevir radi liječenja infekcije hepatitisom C.
English: Findings in repeated dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use include renal and bone toxicity and a decrease in serum phosphate concentration.
Croatian: Nalazi ispitivanja toksičnosti ponovljenih doza provedenih na štakorima, psima i majmunima pri razinama ekspozicije višim ili jednakim kliničkim razinama ekspozicije te s mogućim značajem za kliničku primjenu, uključuju toksičnost za bubrege i kosti i smanjenje koncentracije fosfata u serumu.
English: HBsAg loss/ seroconversion n/a n/a n/a n/a n/a n/a
Croatian: Serologija (%) nestanak HBeAg/ serokonverzija n/p n/p n/p n/p n/p n/p n/p n/p n/p n/p n/p n/p nestanak HBsAg/ serokonverzija n k n n a
English: If you forget to take Tenofovir disoproxil Mylan It is important not to miss a dose of Tenofovir disoproxil Mylan.
Croatian: Ako ste zaboravili uzeti Tenofovir disoproxil Mylan Važno je da ne propustite uzeti dozu lijeka Tenofovir disoproxil Mylan.
English: The choice of tenofovir disoproxil to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients.
Croatian: Odabir tenofovirdizoproksila za liječenje bolesnika zaraženih virusom HIV-1 koji su već liječeni antiretrovirusnim lijekovima mora se temeljiti na individualnom ispitivanju virusne rezistencije i/ili prethodnom liječenju bolesnika.
English: What Tenofovir disoproxil Mylan is and what it is used for
Croatian: Što je Tenofovir disoproxil Mylan i za što se koristi
English: It is recommended that the dosing interval for tenofovir disoproxil 245 mg is modified in adult patients with creatinine clearance < 50 ml/min or in patients who already have ESRD and require dialysis (see section 4.2).
Croatian: Preporučuje se prilagoditi interval doziranja za dozu od 245 mg tenofovirdizoproksila u odraslih bolesnika s klirensom kreatinina < 50 ml/min i u bolesnika koji već imaju bolest bubrega u završnoj fazi i trebaju dijalizu (vidjeti dio 4.2).
English: Table 5: Efficacy parameters in compensated HBeAg positive patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Croatian: Tablica 5: Parametri djelotvornosti u kompenziranih HbeAg pozitivnih bolesnika u 96., 144., 192., 240., 288. i 384. tjednu liječenja u otvorenom ispitivanju
English: If you feel dizzy while taking Tenofovir disoproxil Mylan, do not drive or ride a bicycle and do not use any tools or machines.
Croatian: Ako tijekom uzimanja lijeka Tenofovir disoproxil Mylan imate omaglicu, nemojte upravljati vozilom, voziti se na biciklu niti raditi s alatima ili na strojevima.
English: Confirmed increase in serum creatinine ≥ 0.5 mg/dl from baseline or confirmed serum phosphate of < 2 mg/dl n (%)
Croatian: Potvrđeno povišenje kreatinina u serumu za ≥ 0,5 mg/dl od početne vrijednosti ili potvrđene fosfate u serumu < 0,2 mg/dl n (%)b
English: HIV-1: Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg.
Croatian: HIV-1: Farmakokinetika tenofovira u stanju dinamičke ravnoteže procijenjena je u 8 adolescentnih bolesnika zaraženih HIVom (u dobi od 12 do 18) s tjelesnom težinom ≥ 35 kg.
English: No significant effect on darunavir/ritonavir PK parameters.
Croatian: Bez značajnog učinka na farmakokinetičke parametre lopinavira/ritonavira.
English: Light blue, round, biconvex, film-coated tablets, 12.20 ± 0.20 mm in diameter, debossed with ‘TN245' on one side and ‘M' on other side.
Croatian: Svijetloplave, okrugle, bikonveksne, filmom obložene tablete, promjera 12,20 ± 0,20 mm s utisnutom oznakom „TN245” na jednoj strani i „M” na drugoj strani.
English: Didanosine
Croatian: Didanozin
English: Among 28 patients receiving 96 weeks of treatment with tenofovir disoproxil, BMD Z-scores declined by -0.341 for lumbar spine and -0.458 for total body.
Croatian: U 28 bolesnika koji su primali tenofovirdizoproksil tijekom 96 tjedana, BMD Z-rezultati su se snizili za -0,341 za lumbalnu kralježnicu i -0,458 za cijelo tijelo.
English: Long-term studies to evaluate the benefit/risk of bitherapy with emtricitabine plus tenofovir disoproxil in HBV monoinfected patients are ongoing.
Croatian: Dugoročna ispitivanja evaluacije koristi/rizika dvojne terapije emtricitabinom u kombinaciji s tenofovirdizoproksilom u bolesnika zaraženih samo virusom HBV su u tijeku.
English: Viruses containing the rtA181T mutation remained susceptible to tenofovir with EC50 values 1.5fold that of wild-type virus.
Croatian: Virusi koji sadrže mutaciju rtA181T ostali su osjetljivi na tenofovir s vrijednostima EC50 1,5 puta višim od onih divljeg tipa virusa.
English: 3, the mean baseline plasma HIV-1 RNA was 4.91 log10 copies/ml, 19% of patients had symptomatic HIV-1 infection and 18% had AIDS.
Croatian: HIV-1 RNK u plazmi bila je 4,91 log10 kopija/ml, 19% bolesnika imalo je simptomatsku infekciju virusom HIV-1, a 18% je imalo AIDS.
English: In non-proliferating human peripheral blood mononuclear cells (PBMCs) the half-life of tenofovir diphosphate was found to be approximately 50 hours, whereas the half-life in phytohaemagglutininstimulated PBMCs was found to be approximately 10 hours.
Croatian: U neproliferirajućih humanih mononuklearnih stanica periferne krvi (MSPK) utvrđeno je da je poluvijek tenofovirdifosfata oko 50 sati, a poluvijek u fitohemaglutinin stimuliranom MSPK-u oko 10 sati.
English: Severe renal impairment (creatinine clearance < 30 ml/min) and haemodialysis patients Adequate dose adjustments cannot be applied due to lack of alternative tablet strengths, therefore use in this group of patients is not recommended.
Croatian: Teško oštećenje funkcije bubrega (klirens kreatinina < 30 ml/min) i bolesnici na hemodijalizi Zbog nedostatka tableta drugih jačina nije moguće provesti odgovarajuće prilagodbe doze, pa se primjena u ovoj grupi bolesnika ne preporučuje.
English: Following oral administration of tenofovir disoproxil to HIV infected patients, tenofovir disoproxil is rapidly absorbed and converted to tenofovir.
Croatian: Nakon peroralne primjene tenofovirdizoproksila u bolesnika zaraženih HIV-om, tenofovirdizoproksil brzo se apsorbira i pretvara u tenofovir.
English: Five subjects randomised to emtricitabine plus tenofovir disoproxil experienced HBsAg loss with 2 of these 5 subjects experiencing seroconversion to antiHBs.
Croatian: Pet ispitanika randomiziranih za emtricitabin i tenofovirdizoproksil imalo je nestanak HbsAg, s time da su 2 od tih 5 ispitanika imala serokonverziju na anti-HBs.
English: • changes to your urine and back pain caused by kidney problems, including kidney failure
Croatian: • promjene svojstava mokraće i bol u leđima uzrokovana tegobama s bubrezima, uključujući zatajenje bubrega
English: Interrupting treatment with Tenofovir disoproxil Mylan should also be considered in case of progressive decline of renal function when no other cause has been identified.
Croatian: Prekid liječenja lijekom Tenofovir disoproxil Mylan također treba razmotriti u slučaju progresivnog slabljenja funkcije bubrega ako se nije utvrdio niti jedan drugi uzrok
English: For bottles: after first opening the bottle use within 90 days.
Croatian: Za boce: nakon prvog otvaranja iskoristiti u roku od 90 dana.
English: Pharmacokinetic studies have not been performed with tenofovir disoproxil 245 mg tablets in children under 12 years or with renal impairment.
Croatian: Farmakokinetička ispitivanja s tabletama tenofovirdizoproksila od 245 mg nisu provođena u djece mlađe od 12 godina ili s oštećenjem funkcije bubrega.
English: Five subjects (5.6%) had laboratory findings clinically consistent with proximal renal tubulopathy, 4 of whom discontinued tenofovir disoproxil therapy (median tenofovir disoproxil exposure 331 weeks).
Croatian: Pet ispitanika (5,6 %) imalo je laboratorijske nalaze koji klinički odgovaraju proksimalnoj bubrežnoj tubulopatiji, od kojih je njih 4 prekinulo liječenje tenofovirdizoproksilom (medijan izloženosti tenofovirdizoproksilu iznosio je 331 tjedan).