FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatitis B: Approximately one quarter of patients can be expected to experience adverse reactions following treatment with tenofovir disoproxil, most of which are mild.
Croatian: Hepatitis B: Može se očekivati da će približno jedna četvrtina bolesnika razviti nuspojave nakon liječenja tenofovirdizoproksilom, većina kojih su blage.
English: Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP450-mediated interactions involving tenofovir with other medicinal products is low.
Croatian: Na temelju rezultata in vitro pokusa i s obzirom na poznati put izlučivanja tenofovira, potencijal za interakcije posredstvom CYP450, koje uključuju tenofovirdizoproksil s drugim lijekovima, je nizak.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Tenofovir disoproxil Mylan in patients aged 12 to < 18 years are provided with a physician educational pack containing the Summary of Product Characteristics and an appropriate educational brochure, as detailed below:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet osigurat će da svi liječnici za koje se očekuje da će propisivati/primjenjivati Tenofovir disoproxil Mylan bolesnicima od 12 do ˂ 18 godina dobiju edukacijski paket za liječnike, koji će sadržavati Sažetak opisa svojstava lijeka i odgovarajuću edukacijsku brošuru kako je opisano niže:
English: Warnings and precautions Talk to your doctor or pharmacist before taking Tenofovir disoproxil Mylan
Croatian: Upozorenja i mjere opreza Razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja lijeka Tenofovir disoproxil Mylan.
English: • That Tenofovir disoproxil Mylan may cause a reduction in BMD and the effects of Tenofovir disoproxil Mylan associated changes in BMD on long term bone health and future fracture risk are currently unknown in patients aged 12 to < 18 years.
Croatian: • Da Tenofovir disoproxil Mylan može prouzročiti smanjenje BMD-a i da učinci lijeka Tenofovir disoproxil Mylan povezani s promjenama u BMD-u na dugotrajno zdravlje kostiju i budući rizik od prijeloma u bolesnika od 12 do ˂ 18 godina trenutno nisu poznati.
English: Genotoxicity studies revealed positive results in the in vitro mouse lymphoma assay, equivocal results in one of the strains used in the Ames test, and weakly positive results in an UDS test in primary rat hepatocytes.
Croatian: Ispitivanja genotoksičnosti dala su pozitivne rezultate u in vitro testu mišjeg limfoma, nepouzdane rezultate u jednom soju upotrijebljenom u Amesovom testu i slabo pozitivne rezultate UDS testa (test neplanirane DNK sinteze) na primarnim hepatocitima štakora.
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 posljedičnim prijelomom kostiju), bol u mišićima, slabost mišića i smanjenje razine kalija ili fosfata u krvi mogu nastati zbog oštećenja stanica bubrežnih kanalića.
English: Adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients:
Croatian: Odrasli bolesnici s klirensom kreatinina < 50 ml/min, uključujući bolesnike na hemodijalizi:
English: Tenofovir disoproxil must be taken with food, as food enhances the bioavailability of tenofovir (see section 5.2).
Croatian: Tenofovirdizoproksil se mora uzimati s hranom, jer hrana povećava bioraspoloživost tenofovira (vidjeti dio 5.2).
English: However, in exceptional circumstances Tenofovir disoproxil Mylan 245 mg film-coated tablets can be administered following disintegration of the tablet in at least 100 ml of water, orange juice or grape juice.
Croatian: Međutim, u iznimnim okolnostima, Tenofovir disoproxil Mylan 245 mg filmom obložene tablete mogu se primijeniti nakon otapanja tablete u najmanje 100 ml vode, soka od naranče ili soka od grožđa.
English: As a general rule, it is recommended that HIV and HBV infected women do not breast-feed their infants in order to avoid transmission of HIV and HBV to the infant.
Croatian: Kao opće pravilo, preporučuje se da žene inficirane HIV-om a i HBV-om ne doje svoju dojenčad, kako bi se izbjegao prijenos virusa HIV-a ili virusa HBV-a na dojenče.
English: In vitro protein binding of tenofovir to plasma or serum protein was less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 µg/ml.
Croatian: In vitro vezanje tenofovira za proteine plazme ili seruma bilo je manje od 0,7, odnosno 7,2%, u rasponu koncentracija tenofovira od 0,01 do 25 µg/ml.
English: • foscarnet, ganciclovir, or cidofovir (for viral infection),
Croatian: • foskarnet, ganciklovir ili cidofovir (za virusnu infekciju),
English: What Tenofovir disoproxil Mylan is and what it is used for What you need to know before you take Tenofovir disoproxil Mylan How to take Tenofovir disoproxil Mylan Possible side effects
Croatian: Što je Tenofovir disoproxil Mylan i za što se koristi Što morate znati prije nego počnete uzimati Tenofovir disoproxil Mylan Kako uzimati Tenofovir disoproxil Mylan Moguće nuspojave
English: This medicine is available in plastic bottles with a child resistant cap and wad containing 30 filmcoated tablets and in multipacks of 90 film-coated tablets comprising 3 bottles, each containing 30 film-coated tablets.
Croatian: Ovaj je lijek dostupan u plastičnim bocama sa sigurnosnim zatvaračem za djecu i zaštitnom folijom koje sadrže 30 filmom obloženih tableta i u višestrukim pakiranjima s 90 filmom obloženih tableta u 3 boce od kojih svaka sadrži po 30 filmom obloženih tableta.
English: Excipient with known effect Each tablet contains 155 mg lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta sadrži 155 mg laktoze hidrata.
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 proteaza, a 48% je imalo mutacije povezane s nenukleozidnim inhibitorima reverzne transkriptaze.
English: ANTI-INFECTIVES Antiretrovirals Protease inhibitors Atazanavir/Ritonavir (300 q.d./100 q.d.)
Croatian: Antiretrovirusni lijekovi Inhibitori proteaze Atazanavir/ritonavir (300 q.d./100 q.d.)
English: Tenofovir disoproxil Mylan is not usually taken with other medicines that can damage your kidneys (see Other medicines and Tenofovir disoproxil Mylan).
Croatian: Tenofovir disoproxil Mylan se obično ne uzima s drugim lijekovima koji Vam mogu oštetiti bubrege (pogledajte Drugi lijekovi i Tenofovir disoproxil Mylan).
English: Based upon Long Term Evaluation algorithm (LTE Analysis) - Patients who discontinued the study at any time prior to week 384 due to a protocol defined endpoint, as well as those completing week 384, are included in the denominator.
Croatian: Temelji se na algoritmu dugoročne promjene (LTE analiza) - Bolesnici koji su prekinuli sudjelovanje u ispitivanju bilo kada prije 384. tjedna zbog postizanja protokolom definirane mjere ishoda i oni koji su dovršili 384 tjedna liječenja uključeni su u nazivnik.
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 preporuke doziranja 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: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2, Tenofovir disoproxil Mylan contains lactose), hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, indigo carmine aluminium lake (E132).
Croatian: - Drugi sastojci su mikrokristalična celuloza, laktoza hidrat (pogledajte dio 2, Tenofovir disoproxil Mylan sadrži laktozu), hidroksipropilceluloza, koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza, titanijev dioksid (E171), triacetin, boja indigo karmin aluminium lake (E132).
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: The safety and efficacy of tenofovir disoproxil in HIV-1 infected children under 2 years of age have not been established.
Croatian: Sigurnost i djelotvornost tenofovirdizoproksila u djece s infekcijom virusom HIV-1 mlađe od 2 godine nisu ustanovljene.
English: <For inner carton of multipack:> Component of a multipack, can't be sold separately.
Croatian: 30 filmom obloženih tableta <Za unutranju kutiju višestrukog pakiranja> Dio višestrukog pakiranja, ne smije se prodavati zasebno.
English: • damage to kidney tubule cells
Croatian: • oštećenje stanica bubrežnih tubula
English: 10 film-coated tablets 30 film-coated tablets 30 x 1 film-coated tablets
Croatian: Filmom obložena tableta 10 filmom obloženih tableta 30 filmom obloženih tableta 30 × 1 filmom obložena tableta
English: • aminoglycosides, pentamidine or vancomycin (for bacterial infection),
Croatian: • aminoglikozide, pentamidin ili vankomicin (za bakterijsku infekciju),
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 liječenja tenofovirom, vidjeti gornji tekst Egzacerbacije hepatitisa.
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 kontaminacijom krvlju.
English: acute renal failure, renal failure, acute tubular necrosis, nephritis (including acute interstitial nephritis)
Croatian: akutno zatajenje bubrega, zatajenje bubrega, akutna tubularna nekroza, nefritis, (uključujući akutni intersticijski nefritis)
English: No dose adjustment is recommended.
Croatian: Ne preporučuje se prilagodba doziranja.
English: Table 6: Histological response (%) in compensated HBeAg negative and HBeAg positive subjects at week 240 compared to baseline
Croatian: Tablica 6: Histološki odgovor (%) u kompenziranih HbeAg-negativnih i HbeAg-pozitivnih ispitanika u 240. tjednu u usporedbi s početnim stanjem
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 CYP450, osim na CYP1A1/2, gdje je zapaženo malo (6%), ali statistički značajno smanjenje metabolizma supstrata CYP1A1/2.
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 na dojenče.
English: For dosage see section 3, How to take Tenofovir disoproxil Mylan.
Croatian: Za doziranje pogledajte dio 3, Kako uzimati Tenofovir disoproxil Mylan.
English: Tenofovir disoproxil may cause a reduction in BMD.
Croatian: Tenofovirdizoproksil može uzrokovati smanjenje BMD-a.
English: Following intravenous administration the steady-state volume of distribution of tenofovir was estimated to be approximately 800 ml/kg.
Croatian: Nakon intravenske primjene procijenjeno je da je volumen raspodjele tenofovira u stanju dinamičke ravnoteže bio približno 800 ml/kg.
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: Among them, 3 patients experienced a clinically meaningful decline in estimated GFR which improved after discontinuation of tenofovir disoproxil.
Croatian: Među njima su tri bolesnika imala klinički značajan pad procijenjenog GFR-a koji se poboljšao nakon prekida primjene tenofovirdizoproksila.
English: Normal ALT ≥ 2 point decrease in CPT from baseline n (%)
Croatian: Normalan ALT CPT rezultat smanjen za ≥ 2 boda od početne vrijednosti n (%)
English: - In HBeAg negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy.
Croatian: - Kod HBeAg negativnih bolesnika bez ciroze, liječenje se mora primjenjivati najmanje do pojave HBs serokonverzije ili do dokaza gubitaka djelotvornosti.
English: • If you are an adult and have problems with your kidneys, your doctor may advise you to take Tenofovir disoproxil Mylan less frequently.
Croatian: • Ako ste odrasla osoba i imate problema s bubrezima, možda će Vas liječnik uputiti da rjeđe uzimate Tenofovir disoproxil Mylan.
English: <for bottle label and carton >
Croatian: <za naljepnicu na boci i kutiju>
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 (≥ 40fold the exposure in patients).
Croatian: U mladih odraslih štakora i pasa toksičnost za kosti pokazala se pri izloženosti dozi ≥ 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 (≥ 40 puta veća izloženost nego u bolesnika).
English: Renal and bone effects in paediatric population
Croatian: Učinci na bubrege i kosti u pedijatrijske populacije
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 bili su izdvojeni in vitro i u nekih bolesnika (vidjeti odlomak Klinička djelotvornost i sigurnost).
English: Forty-nine of the 51 nucleoside-experienced patients were previously treated with lamivudine.
Croatian: Četrdeset i devet od 51 bolesnika koji su primali nukleozide bilo je prethodno liječeno lamivudinom.
English: The tablets are also available in blister packs containing 10, 30 or 30 x 1 (unit dose) tablets.
Croatian: Tablete su dostupne i u blisterima koji sadrže 10 tableta, 30 tableta ili 30 x 1 (jedinična doza) tabletu.
English: BOTTLE CARTON AND BOTTLE LABEL
Croatian: KUTIJA I NALJEPNICA BOCE
English: 1 Data generated from simultaneous dosing with ledipasvir/sofosbuvir.
Croatian: Podaci generirani prilikom istovremene primjene s ledipasvirom/sofosbuvirom.
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 koji su u dobi od 12 do manje od 18 godina i imaju tjelesnu težinu od najmanje 35 kg i već su bili liječeni drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistencije ili su prouzročili nuspojave
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCVinfected patients.
Croatian: Ispitivanje provedeno s dodatnom dozom voksilaprevira od 100 mg kako bi se dosegle izloženosti voksilapreviru očekivane u bolesnika zaraženih HCV-om.
English: However, tenofovir disoproxil reduced the viability index and weight of pups in peripostnatal toxicity studies at maternally toxic doses.
Croatian: Ipak, tenofovirdizoproksil smanjio je indeks preživljenja i težinu mladunčadi u perinatalnim i postnatalnim ispitivanjima toksičnosti pri dozama toksičnim za majku.
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).
English: If you are older than this and are prescribed Tenofovir disoproxil Mylan, your doctor will monitor you carefully.
Croatian: Imate li više od 65 godina, a propisali su Vam Tenofovir disoproxil Mylan, liječnik će Vas pažljivo nadzirati.
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 s HIV-om kada se tenofovirdizoproksil kombinirao s lamivudinom i abakavirom, kao i s lamivudinom i didanozinom u režimu liječenja jedanput na dan.
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: 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 (otprilike 210 ml/min), što prelazi brzinu glomerularne filtracije.
English: - In HBeAg positive patients without cirrhosis, treatment should be administered for at least 612 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Croatian: - Kod HBeAg pozitivnih bolesnika bez ciroze, liječenje se mora primjenjivati najmanje 6 do 12 mjeseci nakon potvrđene HBe serokonverzije (nestanak HBeAg i HBV DNK s detekcijom anti-HBe) ili sve do HBs serokonverzije ili do gubitka djelotvornosti (vidjeti dio 4.4).
English: Median HBV DNA reduction from baseline c
Croatian: Medijan smanjenja HBV DNK od početne vrijednosti c
English: However, patients should be informed that dizziness has been reported during treatment with tenofovir disoproxil.
Croatian: No bolesnike je potrebno obavijestiti da je zabilježena omaglica tijekom liječenja tenofovirdizoproksilom.
English: Mean (± SD) Cmax and AUCtau are 0.38 ± 0.13 μg/ml and 3.39 ± 1.22 μg·h/ml, respectively.
Croatian: Srednja vrijednost (±SD) Cmax iznosi 0,38 ± 0,13 μg/ml, a AUCtau 3,39 ± 1,22 μg·h/ml.
English: hepatic steatosis, hepatitis Skin and subcutaneous tissue disorders: Very common:
Croatian: jetrena steatoza, hepatitis Poremećaji kože i potkožnog tkiva: Vrlo često:
English: <for carton only>
Croatian: <samo za kutiju>
English: Danmark BGP Products ApS Tlf: + 45 28116932
Croatian: BGP Products ApS Tlf: + 45 28116932
English: The following side effects are very common (these can affect at least 10 in every 100 patients): • diarrhoea, being sick (vomiting), feeling sick (nausea), dizziness, rash, feeling weak
Croatian: Sljedeće nuspojave su vrlo česte (mogu se javiti u najmanje 10 na svakih 100 bolesnika): • proljev, povraćanje, mučnina, omaglica, osip, slabost
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 nekroupalnoj ljestvici za najmanje dva boda bez pogoršanja Knodellove fibroze) u 48. tjednu (vidjeti tablicu 3 niže).
English: After first opening use within 90 days
Croatian: Nakon prvog otvaranja iskoristiti u roku od 90 dana.
English: Multipack: 90 (3 packs of 30) film-coated tablets
Croatian: Filmom obložena tableta Višestruko pakiranje: 90 (3 pakiranja po 30) filmom obloženih tableta
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) je imalo regresiju ciroze do 240. tjedna i snižen rezultat na Ishakovoj ljestvici fibroze za najmanje 2 boda.
English: Before starting treatment, your doctor may order blood tests to assess your kidney function.
Croatian: Prije početka liječenja, liječnik će Vam možda zatražiti krvne pretrage da bi ocijenio rad bubrega.
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 za ≥ 2 log10 kopija/ml koje je prethodilo ili se podudaralo s povišenjem razine ALT-a.
English: Store in original container in order to protect from light and moisture.
Croatian: Čuvati u originalnom spremniku radi zaštite od vlage i svjetlosti.
English: The recommended dose of tenofovir disoproxil for the treatment of HIV or for the treatment of chronic hepatitis B is 245 mg (one tablet) once daily taken orally with food.
Croatian: Preporučena doza tenofovirdizoproksila za liječenje infekcije virusom HIV-a ili za liječenje kroničnog hepatitisa B je 245 mg (jedna tableta), jedanput na dan, koja se uzima peroralno s hranom.
English: Reduced doses of tenofovir disoproxil are used for treatment of HIV-1 infected paediatric patients aged 2 to < 12 years.
Croatian: Smanjene doze tenofovirdizoproksila upotrebljavaju se za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV 1 u dobi od 2 do < 12 godina.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of enzymes (in HIV reverse transcriptase; in hepatitis B DNA polymerase) that are essential for the viruses to reproduce themselves.
Croatian: Tenofovir je nukleotidni inhibitor reverzne transkriptaze, općenito poznat kao NRTI i djeluje tako što ometa normalan rad enzima (kod HIV-a reverzne transkriptaze, a kod HBV-a DNK polimeraze) koji su tim virusima neophodni za umnožavanje.
English: 2 The predominant circulating metabolite of sofosbuvir.
Croatian: Glavni metabolit sofosbuvira u cirkulaciji.
English: Do not take Tenofovir disoproxil Mylan together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
Croatian: Nemojte istovremeno uzimati Tenofovir disoproxil Mylan i lijekove koji sadrže adefovirdipivoksil (lijek koji se koristi za liječenje kroničnog hepatitisa B).
English: Therefore, in adult patients with renal impairment tenofovir disoproxil should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Croatian: Stoga u odraslih bolesnika s oštećenjem funkcije bubrega tenofovirdizoproksil treba koristiti samo ako se smatra da moguće koristi od liječenja premašuju moguće rizike.