FrancophonIA/ELRC3.0 huggingface dataset:
English: However, tenofovir disoproxil reduced the viability index and weight of pups in a peripostnatal toxicity study at maternally toxic doses.
Croatian: Ipak, tenofovirdizoproksil je smanjio indeks preživljenja i težinu mladunčadi u perinatalnim i postnatalnim ispitivanjima toksičnosti pri dozama toksičnim za majku.
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 patients, HIV-1 expressing three or more thymidine analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced susceptibility to tenofovir disoproxil.
Croatian: Bolesnici u kojih je HIV-1 izražavao tri ili više mutacija povezanih s analogom timidina (TAMs; engl. thymidine-analoque associated mutations), koje su uključivale bilo M41L ili L210W mutaciju reverzne transkriptaze, pokazali su smanjenu osjetljivost na tenofovirdizoproksil.
English: The results reported from a prospective study (IMPAACT P1026s) showed that treatment with cobicistat and elvitegravir-containing regimens during pregnancy results in lower elvitegravir and cobicistat exposures (Table 5).
Croatian: Prijavljeni rezultati prospektivnog ispitivanja (IMPAACT P1026s) pokazali su da liječenje režimima koji sadrže kobicistat i elvitegravir tijekom trudnoće rezultira nižom izloženošću elvitegraviru i kobicistatu (Tablica 5).
English: Following administration of [14C]emtricitabine, complete recovery of the emtricitabine dose was achieved in urine (~ 86%) and faeces (~ 14%).
Croatian: Nakon primjene [14C]emtricitabina, potpuna izolacija doze emtricitabina ostvarena je u urinu (~86%) i stolici (~14%).
English: • sedatives and hypnotics, used to treat anxiety: buspirone, clorazepate, diazepam, estazolam, flurazepam and zolpidem
Croatian: • sedative i hipnotike, primjenjuju se za liječenje tjeskobe: buspiron, klorazepat, diazepam, estazolam, flurazepam i zolpidem
English: Antiviral synergy was maintained for elvitegravir, emtricitabine, and tenofovir when tested in the presence of cobicistat.
Croatian: Antivirusna sinergija održana je za elvitegravir, emtricitabin i tenofovir prilikom ispitivanja u prisutnosti kobicistata.
English: elevated amylase including elevated pancreatic amylase1, elevated serum lipase1, abdominal pain, dyspepsia, constipation, abdominal distension1, flatulence
Croatian: povišena amilaza uključujući povišenu amilazu gušterače1, povišena lipaza u serumu1, bol u abdomenu, dispepsija, konstipacija, distenzija abdomena1, flatulencija
English: In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in BMD of the hip and spine were observed in both treatment groups.
Croatian: U kontroliranom kliničkom ispitivanju koje je trajalo 144 tjedna i u kojemu je uspoređivan tenofovirdizoproksil sa stavudinom u kombinaciji s lamivudinom i efavirenzom u bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima, u obje ispitivane skupine su zapažena mala smanjenja mineralne gustoće kosti (BMD) kuka i kralježnice.
English: However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Croatian: Međutim, nakon 144. tjedna nije bilo povećanog rizika od prijeloma ili dokaza klinički značajnih koštanih poremećaja.
English: Patients had to be stably suppressed for at least six months prior to study entry, have no current or past history of resistance to the antiretroviral components of Stribild, and have HIV-1 RNA < 50 copies/mL at screening.
Croatian: U bolesnika je virus morao biti stabilno suprimiran najmanje šest mjeseci prije uključenja u ispitivanje, nisu smjeli imati zabilježenu prošlu ili sadašnju rezistenciju na antiretrovirusne tvari u Stribildu i morali su imati HIV-1 RNK < 50 kopija/ml na probiru.
English: Contains lactose, see leaflet for further information.
Croatian: POPIS POMOĆNIH TVARI Sadrži laktozu, za dodatne informacije vidjeti uputu o lijeku.
English: The pharmacokinetics of elvitegravir or cobicistat in paediatric subjects <12 years of age have not been fully established.
Croatian: Farmakokinetika elvitegravira ili kobicistata u pedijatrijskih ispitanika mlađih od 12 godina nije potpuno ustanovljena.
English: After oral administration of emtricitabine or tenofovir disoproxil, emtricitabine and tenofovir are widely distributed throughout the body.
Croatian: Nakon peroralne primjene emtricitabina ili tenofovirdizoproksila, emtricitabin i tenofovir se široko distribuiraju po tijelu.
English: Co-administration with Stribild may lead to increased tenofovir exposure.
Croatian: Istodobna primjena sa Stribildom može povećati izloženost tenofoviru.
English: Stribild should not be initiated in patients with creatinine clearance below 70 mL/min (see sections 4.4 and 5.2).
Croatian: Primjenu Stribilda se ne smije započeti u bolesnika s klirensom kreatinina ispod 70 ml/min (vidjeti dijelove 4.4 i 5.2).
English: Both emtricitabine triphosphate and tenofovir diphosphate are weak inhibitors of mammalian DNA polymerases and there was no evidence of toxicity to mitochondria in vitro and in vivo.
Croatian: I emtricitabin trifosfat i tenofovirdifosfat slabi su inhibitori DNK polimeraza sisavaca, te nije dokazana toksičnost po mitohondrije in vitro i in vivo.
English: Substantial cross-resistance was observed between most elvitegravir-resistant HIV-1 isolates and raltegravir, and between emtricitabine-resistant isolates and lamivudine.
Croatian: Zapažena je značajna križna rezistencija između većine HIV-1 izolata rezistentnih na elvitegravir i raltegravira, te između izolata rezistentnih na emtricitabin i lamivudina.
English: It is recommended to separate Stribild and antacid administration by at least 4 hours.
Croatian: Preporučuje se primjenu Stribilda razdvojiti od primjene antacida za najmanje 4 sata.
English: Stribild is indicated for use as a complete regimen for the treatment of HIV-1 infection and must not be administered with other antiretroviral products (see section 4.5).
Croatian: Stribild je indiciran za primjenu kao potpuni režim liječenja infekcije HIV-1 i ne smije se primjenjivati s drugim antiretrovirusnim lijekovima (vidjeti dio 4.5).
English: Co-administration is contraindicated with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Croatian: Kontraindicirana je istodobna primjena s lijekovima čiji klirens uvelike ovisi o CYP3A i kod kojih su povišene koncentracije u plazmi povezane s ozbiljnim i/ili životno opasnim događajima.
English: For the treatment of erectile dysfunction, it is recommended that a single dose of sildenafil no more than 25 mg in 48 hours, vardenafil no more than 2.5 mg in 72 hours, or tadalafil no more than 10 mg in 72 hours be co-administered with Stribild.
Croatian: Radi liječenja erektilne disfunkcije, jedna doza sildenafila od najviše 25 mg u 48 sati, vardenafila od najviše 2,5 mg u 72 sata ili tadalafila od najviše 10 mg u 72 sata preporučuje se smije primijeniti istodobno sa Stribildom.
English: Decreases in BMD of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil treatment group at 144 weeks.
Croatian: Smanjenja BMD-a kralježnice i promjene koštanih biomarkera od početne vrijednosti bila su u 144. tjednu značajno veća u skupini koja je liječena tenofovirdizoproksilom.
English: Concomitant use of Stribild and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Croatian: Istodobnom primjenom Stribilda i kortikosteroida koji se metaboliziraju putem CYP3A (npr. flutikazonpropionata ili drugih inhalacijskih ili nazalnih kortikosteroida) može se povećati rizik od razvoja sistemskih učinaka kortikosteroida, uključujući Cushingov sindrom i adrenalnu supresiju.
English: When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/mL at week 48.
Croatian: Kada su isključeni podaci koji su nedostajali, 91% bolesnika u skupini liječenoj tenofovirdizoproksilom i 94% bolesnika u skupini liječenoj stavudinom ili zidovudinom imalo je koncentracije HIV-1 RNK < 400 kopija/ml u 48. tjednu.
English: Co-administration is contraindicated with medicinal products that are strong inducers of CYP3A due to the potential for loss of virologic response and possible resistance to Stribild.
Croatian: Kontraindicirana je istodobna primjena s lijekovima koji su snažni induktori CYP3A zbog mogućeg gubitka virološkog odgovora i moguće rezistencije na Stribild.
English: rhabdomyolysis1,3, muscular weakness1,3
Croatian: rabdomioliza1,3, mišićna slabost1,3
English: That tenofovir disoproxil fumarate may cause a reduction in BMD and the effects of tenofovir disoproxil fumarate associated changes in BMD on long term bone health and future fracture risk are currently unknown in adolescent patients.
Croatian: Da tenofovirdizoproksilfumarat može prouzročiti smanjenje mineralne gustoće kostiju (BMD) te da učinci promjene BMD-a na dugoročno zdravlje kostiju i rizik od prijeloma prouzročene tenofovirdizoproksilfumaratom trenutačno nisu poznati u adolescentnih bolesnika.
English: If the patient vomits within 1 hour of taking Stribild another tablet should be taken.
Croatian: Ako bolesnik povraća unutar 1 sata od uzimanja Stribilda, mora uzeti drugu tabletu.
English: See section 4.4 regarding initiation of Stribild in patients with creatinine clearance below 90 mL/min.
Croatian: Vidjeti dio 4.4 u vezi početka liječenja Stribildom u bolesnika s klirensom kreatinina ispod 90 ml/min.
English: BMD Z-scores declined by -0.012 for lumbar spine and by -0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Croatian: Z-vrijednost BMD-a smanjila se za -0,012 u lumbalnoj kralježnici te za -0,338 u cijelom tijelu u 64 ispitanika liječena tenofovirdizoproksilom tijekom 96 tjedana.
English: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Stribild with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Croatian: Kako se emtricitabin i tenofovir primarno eliminiraju putem bubrega, istodobna primjena Stribilda i lijekova koji smanjuju funkciju bubrega ili se natječu za aktivnu tubularnu sekreciju (npr. cidofovir) može povećati serumske koncentracije emtricitabina, tenofovira i/ili istodobno primijenjenih lijekova.
English: No virologic data at Week 48 or 144 window Discontinued study drug due to AE or deathd
Croatian: Virološki neuspjehc Bez viroloških podataka u okviru 48. tjedna ili 144. tjedna Prekid primanja ispitivanog lijeka zbog nuspojava ili smrtid
English: The types of renal adverse reactions seen with Stribild were consistent with previous experience with tenofovir disoproxil.
Croatian: Tipovi nuspojava na bubrezima zabilježene kod Stribilda bile su konzistentne s prijašnjim iskustvima s tenofovirdizoproksilom.
English: No emergent resistance to Stribild was detected through Week 48.
Croatian: Do 48. tjedna nije zabilježena novonastala rezistencija na Stribild.
English: See section 4.4 regarding patients with creatinine clearance that falls below 70 mL/min while on treatment with Stribild.
Croatian: Vidjeti dio 4.4 u vezi bolesnika s klirensom kreatinina koji pada ispod 70 ml/min za vrijeme liječenja Stribildom.
English: Your doctor will also order blood tests during treatment to monitor your kidneys.
Croatian: Liječnik će zatražiti krvne pretrage i tijekom liječenja u cilju praćenja funkcije Vaših bubrega.
English: Stribild should be discontinued in patients with confirmed creatinine clearance that falls to < 50 mL/min (since the required dose interval adjustments are not possible using this fixed dose combination tablet) or with decreases in serum phosphate to < 0.32 mmol/L (1.0 mg/dL) (see sections 4.2 and 5.2).
Croatian: Primjena Stribilda mora se prekinuti u bolesnika u kojih je potvrđeno sniženje klirensa kreatinina na < 50 ml/min (s obzirom da potrebne prilagodbe intervala doziranja nisu moguće uporabom ove kombinirane tablete fiksne doze) ili s padom fosfata u serumu na < 0,32 mmol/l (1,0 mg/dl) (vidjeti dijelove 4.2 i 5.2).
English: Creatinine clearance, serum phosphate, urine glucose and urine protein should be monitored every four weeks during the first year and then every three months during Stribild therapy.
Croatian: Mora se pratiti klirens kreatinina, vrijednost fosfata u serumu i glukoze i proteina u urinu svaka četiri tjedna tijekom prve godine, a nakon toga svaka tri mjeseca tijekom terapije Stribildom.
English: At Week 48, 44 of 50 (88%) adolescent patients treated with Stribild achieved HIV-1 RNA <50 copies/mL and 4 achieved HIV-1 RNA ≥50 copies/mL; 1 patient discontinued study drug, and 1 had no virologic data at Week 48.
Croatian: U 48. tjednu, u 44 od 50 (88%) adolescentnih bolesnika liječenih Stribildom postignuta je vrijednost HIV-1 RNK < 50 kopija/ml, a u 4 bolesnika vrijednost HIV-1 RNK ≥ 50 kopija/ml, 1 bolesnik je prekinuo primjenu ispitivanog lijeka, a za 1 bolesnika ne postoje virološki podaci u 48. tjednu.
English: How to take Stribild
Croatian: Kako uzimati Stribild
English: Tenofovir disoproxil may cause a reduction in BMD.
Croatian: Tenofovirdizoproksil može uzrokovati smanjenje mineralne gustoće kostiju (BMD).
English: Stribild is also used to treat 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 that have caused side effects.
Croatian: Stribild se također primjenjuje za liječenje adolescenata zaraženih virusom HIV-1 u dobi od 12 do 18 godina i tjelesnom težinom od najmanje 35 kg, koji su ranije bili liječeni drugim lijekovima protiv HIV-a koji su prouzročili nuspojave.
English:  If you notice any of these symptoms tell your doctor.
Croatian: Ako primijetite bilo koji od ovih simptoma, obavijestite svog liječnika.
English: Both elvitegravir and cobicistat are primarily metabolised and eliminated by the liver.
Croatian: Elvitegravir i kobicistat prvenstveno se metaboliziraju i eliminiraju putem jetre.
English: In patients at risk for renal impairment a more frequent monitoring of renal function is required.
Croatian: U bolesnika s rizikom od oštećenja bubrega, potrebno je češće pratiti funkciju bubrega.
English: Cobicistat exposures were unaffected by a light meal and although there was a modest decrease of 24% and 18% in Cmax and AUC respectively with a high-fat meal, no difference was observed in its pharmacoenhancing effect on elvitegravir.
Croatian: Lagani obrok nije utjecao na izloženost kobicistatu, iako je došlo do umjerenog pada vrijednosti Cmax i AUC od 24%, odnosno 18% s visokomasnim obrokom, nikakva razlika nije zapažena u pojačavajućem farmakološkom učinku na elvitegravir.
English: Mean percentage decreases in BMD from baseline to Week 144 in the Stribild group were comparable to the ATV/r+FTC/tenofovir disoproxil group at the lumbar spine (-1.43% versus -3.68%, respectively) and at the hip (-2.83% versus -3.77%, respectively).
Croatian: Smanjenja srednje vrijednosti postotka BMD-a od početne vrijednosti do 144. tjedna u skupini koja je primala Stribild bila su usporediva sa skupinom koja je primala ATV/r+FTC/tenofovirdizoproksil u lumbalnom dijelu kralježnice (-1,43% naspram -3,68%), odnosno u kuku (-2,83% naspram -3,77%).
English: That use of Stribild should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Croatian: Da se primjenu Stribilda mora izbjegavati kod istodobne ili nedavne primjene nefrotoksičnih lijekova.
English: That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil fumarate-containing products such as Stribild.
Croatian: Da u bolesnika zaraženih HIV-om postoji povećan rizik od bubrežne bolesti povezan s lijekovima koji sadrže tenofovirdizoproksilfumarat, kao što je Stribild.
English: Stribild contains lactose monohydrate.
Croatian: Stribild sadrži laktozu hidrat.
English: In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Croatian: U bolesnika inficiranih HIV-om s teškom imunodeficijencijom u vrijeme uvođenja CART može doći do upalne reakcije na asimptomatske ili rezidualne oportunističke patogene, koja može uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
English: Among the 50 paediatric patients receiving Stribild, mean BMD increased from baseline to Week 48, +0.68% for lumbar spine and +0.77% for total body less head.
Croatian: U 50 pedijatrijskih bolesnika koji su primali Stribild, srednja vrijednost BMD-a povećala se od početne do 48. tjedna za +0,68% u lumbalnoj kralježnici i +0,77% za cijelo tijelo s izuzetkom glave.
English: The K65R substitution can also be selected by abacavir, stavudine or didanosine and results in reduced susceptibility to these agents plus lamivudine, emtricitabine and tenofovir.
Croatian: Supstitucija K65R može se također selektivno izdvojiti s abakavirom, stavudinom ili didanozinom, a rezultira smanjenom osjetljivošću na ove lijekove kao i na lamivudin, emtricitabin i tenofovir.
English: Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets
Croatian: Stribild 150 mg/150 mg/200 mg/245 mg filmom obložene tablete
English: Elvitegravir undergoes oxidative metabolism by CYP3A (major route), and glucuronidation by UGT1A1/3 enzymes (minor route).
Croatian: Elvitegravir prolazi kroz oksidativni metabolizam putem CYP3A (glavni put) i kroz glukuronidaciju putem UGT1A1/3 (sporedni put).
English: Co-administration with Stribild may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk.
Croatian: Istodobna primjena s lijekom Stribild može dovesti do povećanih koncentracija DOAC-a u plazmi što može dovesti do povećane opasnosti od krvarenja.
English: Plasma concentrations of these medicinal products may be increased when co-administered with Stribild, resulting in reduced serum cortisol concentrations.
Croatian: Mogu biti povećane koncentracije tih lijekova u plazmi kada se primjenjuju istodobno sa Stribildom, što dovodi do smanjenih koncentracija kortizola u serumu.
English: Dose modifications are not necessary when administered in combination with Stribild.
Croatian: Izmjene doze nisu potrebne kada se primjenjuje u kombinaciji sa Stribildom.
English: Cobicistat has no detectable anti-HIV activity and does not antagonise or enhance the antiviral effects of elvitegravir, emtricitabine, or tenofovir.
Croatian: Za kobicistat nije otkriveno anti-HIV djelovanje, te on ne antagonizira niti pojačava antivirusne učinke elvitegravira, emtricitabina ili tenofovira.
English: The median terminal plasma half-life of cobicistat following administration of Stribild is approximately 3.5 hours and the associated cobicistat exposures provide elvitegravir Ctrough approximately 10-fold above the protein-binding adjusted IC95 for wild-type HIV-1 virus.
Croatian: Medijan poluvremena kobicistata u plazmi nakon primjene Stribilda iznosi oko 3,5 sati i povezane izloženosti kobicistatu omogućuju Ctrough elvitegravira oko 10 puta više od prilagođene vrijednosti IC95 vezivanja proteina za divlji tip virusa HIV-1.
English: As of Week 144, the development of one or more primary elvitegravir, emtricitabine, or tenofovir resistance-associated substitutions was observed in 18 of the 42 patients with evaluable genotypic data from paired baseline and Stribild treatment-failure isolates (2.6%, 18/701 patients).
Croatian: Od 144. tjedna razvoj jedne ili više primarnih supstitucija povezanih s rezistencijom na elvitegravir, emtricitabin ili tenofovir zapažen je u 18 od 42 bolesnika s procjenjivim genotipskim podacima iz uparene početne vrijednosti i izolata iz neuspješnog liječenja Stribildom (2,6%, 18/701 bolesnika).
English: Co-administration of Stribild and rifabutin is not recommended.
Croatian: Ne preporučuje se istodobna primjena Stribilda i rifabutina.
English: In Study GS-US-236-0123, patients had to have previously only received RAL in combination with FTC/tenofovir disoproxil as their first antiretroviral regimen for at least six months.
Croatian: U ispitivanju GS-US-236-0123 bolesnici su prethodno smjeli primati samo RAL u kombinaciji s FTC/tenofovirdizoproksil kao prvi antiretrovirusni režim tijekom najmanje šest mjeseci.
English: At week 48, 83% of patients in the tenofovir disoproxil treatment group and 92% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/mL.
Croatian: U 48. tjednu, 83% bolesnika u skupini liječenoj tenofovirdizoproksilom i 92% bolesnika u skupini liječenoj stavudinom ili zidovudinom imalo je koncentracije HIV-1 RNK < 400 kopija/ml.
English: Effects on drug levels Mean percent change in AUC, Cmax,
Croatian: Učinci na razinu lijekova Srednja vrijednost postotka promjene AUC, Cmax, Cmin1
English: Cobicistat is metabolised via CYP3A and/or CYP2D6-mediated oxidation and does not undergo glucuronidation.
Croatian: Kobicistat se metabolizira putem CYP3A i/ili oksidacije posredovanom CYP2D6 te ne prolazi kroz glukuronidaciju.
English: In subjects with creatinine clearance below 50 mL/min or with end stage renal disease requiring dialysis, Cmax, and AUC of emtricitabine and tenofovir were increased (see section 4.4).
Croatian: U ispitanika s klirensom kreatinina ispod 50 ml/min ili s bubrežnom bolešću u završnoj fazi koja zahtijeva dijalizu bile su povećane vrijednosti Cmax i AUC emtricitabina i tenofovira (vidjeti dio 4.4).
English: The importance of regular monitoring of creatinine clearance, serum phosphate, urine glucose and urine protein during Stribild therapy.
Croatian: Važnost redovitog nadziranja klirensa kreatinina, fosfata u serumu i glukoze i proteina u urinu tijekom terapije Stribildom.
English: There is insufficient information on the effects of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil in newborns/infants.
Croatian: Nema dovoljno podataka o učincima elvitegravira, kobicistata, emtricitabina i tenofovirdizoproksila u novorođenčadi/dojenčadi.
English: 25-O-desacetyl-rifabutin AUC: ↑ 525% Cmin: ↑ 394% Cmax: ↑ 384%
Croatian: 25-O-dezacetilrifabutin AUC: ↑ 525% Cmin: ↑ 394% Cmax: ↑ 384%
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: Uslijed oštećenja stanica bubrežnih kanalića može doći do razgradnje mišića, omekšavanja kostiju (uz bolove u kostima i ponekad posljedičnim prijelomima), boli u mišićima, slabosti mišića i smanjenja koncentracije kalija ili fosfata u krvi.
English: Non-clinical data on tenofovir disoproxil reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Croatian: Neklinički podaci o tenofovirdizoproksilu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.