FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Dizoproksiltenofovirat ni imel pri koncentraciji 100 μmol/l nobenega vpliva na katero koli obliko CYP450 izoformov, izjema je CYP1A1/2, kjer so opazili majhno (6%) toda statistično pomembno zmanjšanje presnove substrata za CYP1A1/2.
English: Due to limitations of the study, a benefit of tenofovir disoproxil over placebo was not demonstrated based on plasma HIV-1 RNA levels at week 24.
Slovenian: Zaradi omejitev študije koristi dizoproksiltenofovirata v primerjavi s placebom v 24. tednu na podlagi ravni plazemski HIV-1 RNA niso dokazali.
English: The use of tenofovir disoproxil may be considered during pregnancy, if necessary.
Slovenian: Če je potrebno, se lahko pretehta možnost uporabe dizoproksiltenofovirata med nosečnostjo.
English: Findings in the rat and monkey studies indicated that there was a substancerelated decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Slovenian: Rezultati študij izvedenih na podganah in opicah so pokazala z učinkovino povezano zmanjšanje absorpcije fosfata v črevesju s potencialno sekundarnim zmanjšanjem MGK.
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.
Slovenian: Ugotovitve iz študij toksičnosti pri ponavljajočih se odmerkih pri podganah, psih in opicah pri stopnjah izpostavljenosti, ki so bile večje ali enake stopnjam klinične izpostavljenosti, in ki so morda pomembne za klinično uporabo, vključujejo toksičen vpliv na ledvice in kosti in zmanjšanje koncentracije serumskega fosfata.
English: • adults
Slovenian: • odrasle
English: If you have hepatitis B or HIV and hepatitis B together (co-infection), it is very important not to stop your Tenofovir disoproxil Zentiva treatment without talking to your doctor first.
Slovenian: Če ste okuženi s hepatitisom B ali sočasno okuženi z virusom HIV in hepatitisom B, je zelo pomembno, da ne prenehate z zdravljenjem z zdravilom Dizoproksiltenofovirat Zentiva, ne da bi se prej posvetovali z zdravnikom.
English: Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
Slovenian: Bolniki s cirozo so lahko bolj izpostavljeni tveganju za jetrno dekompenzacijo po poslabšanju hepatitisa, zato jih je treba med zdravljenjem skrbno nadzorovati.
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.
Slovenian: Na osnovi rezultatov z in vitro preizkusov in glede na znano pot izločanja tenofovirja je možnost za s CYP450 posredovano interakcijo tenofovirja z drugimi zdravili majhna.
English: hepatic steatosis, hepatitis Skin and subcutaneous tissue disorders: Very common:
Slovenian: jetrna steatoza, hepatitis Bolezni kože in podkožja: Zelo pogosti:
English: Your doctor may order blood tests during treatment to monitor how your kidneys work.
Slovenian: Vaš zdravnik bo morda naredil krvne preiskave v času zdravljenja, da bo nadzoroval delovanje vaših ledvic.
English: Tenofovir pharmacokinetics were not substantially altered in subjects with hepatic impairment suggesting that no dose adjustment is required in these subjects.
Slovenian: Farmakokinetika tenofovirja se pri osebah z motnjami v delovanju jeter ni bistveno spremenila, kar nakazuje, da pri teh osebah ni potrebno prilagoditi odmerjanja.
English: Other special population(s)
Slovenian: Druga(e) posebna(e) populacija(e)
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).
Slovenian: V študijah so ugotovili, da pri aktivni tubularni sekreciji tenofovir vstopa v celice proksimalnih tubulov preko prenašalcev hOAT (human organic anion transporter) 1 in 3, v urin pa izstopa preko beljakovine MRP 4 (multidrug resistant protein 4).
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.
Slovenian: Genotipska analiza HIV izolatov pri 253 bolnikih je ob začetku študije odkrila, da ima 94% bolnikov HIV-1 mutacije za rezistenco povezane z nukleozidnimi zaviralci reverzne transkriptaze, 58% je imelo mutacije, povezane s proteaznimi zaviralci, in 48% je imelo mutacije, povezane z nenukleozidnimi zaviralci reverzne transkriptaze.
English: If you take more Tenofovir disoproxil Zentiva than you should If you accidentally take too many Tenofovir disoproxil Zentiva tablets, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Slovenian: Če ste vzeli večji odmerek Dizoproksiltenofovirat Zentiva, kot bi smeli Če ste pomotoma zaužili preveč tablet zdravila Dizoproksiltenofovirat Zentiva, se lahko poveča tveganje pojava možnih neželenih učinkov povezanih s tem zdravilom (glejte poglavje 4, Možni neželeni učinki).
English: Moderate renal impairment (creatinine clearance 30 - 49 ml/min) If administration of a lower dose is not possible, prolonged dose intervals using the 245 mg film-coated tablets may be used.
Slovenian: Zmerna ledvična okvara (očistek kreatinina od 30-49 ml/min) Če dajanje nižjega odmerka ni mogoče, se lahko uporabijo podaljšani odmerni intervali z 245 mg filmsko obložene tablete.
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.
Slovenian: V izjemnih primerih, pri bolnikih, ki imajo posebne težave pri požiranju, pa se lahko zdravilo Dizoproksiltenofovirat Zentiva zaužije razdrobljeno v najmanj 100 ml vode, pomarančnega ali grozdnega soka.
English: It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with tenofovir disoproxil and renal function (creatinine clearance and serum phosphate) is also monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors.
Slovenian: Pred začetkom zdravljenja z dizoproksiltenofoviratom se priporoča izračun očistka kreatinina pri vseh bolnikih in nadzor delovanja ledvic (očistek kreatinina in koncentracija serumskega fosfata) po dveh do štirih tednih zdravljenja, po treh mesecih zdravljenja in zatem vsake tri do šest mesecev pri bolnikih brez dejavnikov tveganja za ledvice.
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.
Slovenian: Sočasna okužba s hepatitisom C ali D: Podatkov o učinkovitosti tenofovirja pri bolnikih s sočasno okužbo z virusom hepatitisa C ali D ni.
English: Reductions in BMD have been reported in paediatric patients.
Slovenian: Poročali so o zmanjšanju MGK pri pediatričnih bolnikih.
English: One patient in the tenofovir disoproxil arm developed the K70E substitution in the virus.
Slovenian: Pri enem bolniku v skupini z dizoproksiltenofoviratom se je pri virusu razvila substitucija K70E.
English: No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 4.4).
Slovenian: Podatkov, na osnovi katerih bi lahko priporočili odmerke za bolnike starejše od 65 let, ni na voljo (glejte poglavje 4.4).
English: If you notice signs of inflammation or infection, tell your doctor at once.
Slovenian: Če opazite simptome vnetja ali okužbe, o tem nemudoma obvestite zdravnika.
English: If you have particular difficulty swallowing, you can use the tip of a spoon to crush the tablet.
Slovenian: Če imate težave s pogoltnjenjem, lahko tableto zdrobite s konico žlice.
English: Based on these data, it is unlikely that clinically significant interactions involving tenofovir disoproxil and medicinal products metabolised by CYP450 would occur.
Slovenian: Na podlagi teh podatkov ni verjetno, da bi prišlo do klinično pomembnih interakcij med dizoproksiltenofoviratom in zdravili, ki jih presnavlja CYP450.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo na vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Oblong-shaped, light blue colored film-coated tablets with dimensions approx. 17.2 x 8.2 mm.
Slovenian: Podolgovate, svetlo modro obarvane filmsko obložene tablete velikosti približno 17,2 x 8,2 mm.
English: Co-infection with HIV-1 and hepatitis B: Due to the risk of development of HIV resistance, tenofovir disoproxil should only be used as part of an appropriate antiretroviral combination regimen in HIV/HBV co-infected patients.
Slovenian: Sočasna okužba z virusom HIV-1 in virusom hepatitisa B: Zaradi tveganja za nastanek odpornosti virusa HIV se sme dizoproksiltenofovirat pri bolnikih, okuženih z virusoma HIV/HBV, uporabljati samo kot del ustreznega režima kombiniranega protiretrovirusnega zdravljenja.
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.
Slovenian: In vitro je bila vezava tenofovirja na plazemske proteine manjša od 0,7% oziroma na serumske proteine manjša od 7,2% v koncentracijskem območju tenofovirja od 0,01 do 25 μg/ml.
English: The EC50 values for tenofovir were in the range of 0.14 to 1.5 µmol/l, with CC50 (50% cytotoxicity concentration) values > 100 µmol/l.
Slovenian: Vrednosti EC50 za tenofovir so bile v razponu od 0,14 do 1,5 μmol/l, vrednosti CC50 (50% citotoksične koncentracije) pa so bile > 100 μmol/l.
English: BMD Z-scores were not adjusted for height and weight.
Slovenian: Zindeksi MGK niso bili prilagojeni telesni višini in masi.
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.
Slovenian: • Prav tako je pomembno, da svojemu osebnemu zdravniku poveste, če jemljete ledipasvir/sofosbuvir, sofosbuvir/velpatasvir ali sofosbuvir/velpatasvir/voksilaprevir za zdravljenje okužbe s hepatitisom C.
English: n (%)a
Slovenian: n (%)
English: However, administration of tenofovir disoproxil with a light meal did not have a significant effect on the pharmacokinetics of tenofovir.
Slovenian: Vendar pa jemanje dizoproksiltenofovirata z lažjim obrokom ni imelo bistvenega vpliva na farmakokinetiko tenofovirja.
English: HIV-1 and hepatitis B: In patients receiving tenofovir disoproxil, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have been reported.
Slovenian: HIV-1 in hepatitis B: Pri bolnikih, ki so prejemali dizoproksiltenofovirat so poročali o redkih dogodkih ledvične okvare, ledvične odpovedi in občasnih dogodkih proksimalne ledvične tubulopatije (vključno s Fanconijevim sindromom), ki včasih vodijo k anomalijam na kosteh (redko prispevajo k zlomom).
English: Tenofovir disoproxil Zentiva is not suitable for the following groups:
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva ni primerno za naslednje skupine:
English: Therefore, a multidisciplinary approach is recommended to adequately weigh on a case by case basis the benefit/risk balance of treatment, decide the appropriate monitoring during treatment (including decision for treatment withdrawal) and consider the need for supplementation.
Slovenian: Zato se pri ocenjevanju razmerja koristi in tveganj pri zdravljenju, odločanju o ustreznem nadziranju med zdravljenjem (vključno z odločitvijo za prenehanje zdravljenja) in razmisleku o potrebi po dodatkih za vsak primer posebej priporoča multidisciplinarni pristop.
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.
Slovenian: Rezultati so pokazali, da so bolniki, katerih HIV je izražal tri ali več mutacij, povezanih z analogom timidina (TAM, thymidine-analogue associated mutations), ki so vsebovale ali M41L ali L210W mutacijo reverzne transkriptaze, kazali zmanjšan odziv na zdravljenje z 245 mg dizoproksiltenofovirata.
English: Rarely, pancreatitis and lactic acidosis, sometimes fatal, have been reported (see section 4.4).
Slovenian: Redko so poročali o pankreatitisu in laktacidozi, ki sta bila včasih smrtna (glejte poglavje 4.4).
English: Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva je indicirano tudi za zdravljenje mladostnikov, okuženih s HIV1, odpornih na NRTI ali s toksičnostjo, ki onemogoča uporabo zdravil prve izbire, starih 12 do < 18 let.
English: The adverse reactions observed with continued treatment for 384 weeks were consistent with the safety profile of tenofovir disoproxil.
Slovenian: Neželeni učinki, ki so jih opazili v 384-tedenskem neprekinjenem zdravljenju, so bili v skladu z varnostnim profilom dizoproksiltenofovirata.
English: What Tenofovir disoproxil Zentiva is and what it is used for What you need to know before you take Tenofovir disoproxil Zentiva How to take Tenofovir disoproxil Zentiva Possible side effects
Slovenian: Kaj je zdravilo Dizoproksiltenofovirat Zentiva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Dizoproksiltenofovirat Zentiva Kako jemati zdravilo Dizoproksiltenofovirat Zentiva Možni neželeni učinki
English: • adolescents aged 12 to less than 18 years who have already been treated with other HIV
Slovenian: • mladostnike, stare 12 do manj kot 18 let, predhodno že zdravljene z drugimi zdravili proti
English: LIST OF EXCIPIENTS Contains lactose monohydrate.
Slovenian: LIST OF EXCIPIENTS Vsebuje laktozo monohidrat.
English: While taking Tenofovir disoproxil Zentiva you may still develop infections or other illnesses associated with HIV infection.
Slovenian: Med jemanjem zdravila Dizoproksiltenofovirat Zentiva se lahko še naprej razvijejo okužbe ali druge bolezni povezane s HIV infekcijo.
English: - decompensated liver disease (see sections 4.4, 4.8 and 5.1).
Slovenian: - dekompenzirano jetrno boleznijo (glejte poglavja 4.4, 4.8 in 5.1).
English: Moreover, at concentrations substantially higher (approximately 300-fold) than those observed in vivo, tenofovir did not inhibit in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation (CYP3A4, CYP2D6, CYP2C9, CYP2E1, or CYP1A1/2).
Slovenian: Poleg tega tenofovir in vitro pri koncentracijah, ki so bistveno višje (približno 300 krat) od koncentracij opaženih in vivo, ni zaviral presnavljanja zdravil, ki se biotransformirajo s katero koli od pomembnejših izoform glavnega humanega CYP450 (CYP3A4, CYP2D6, CYP2C9, CYP2E1 ali CYP1A1/2).
English: In studies GS-US-174-0102 and GS-US-174-0103, 77% and 61% of patients continued in the study through to 384 weeks, respectively.
Slovenian: V študijah GS-US-174-0102 in GS-US-1740103 je do 384. tedna sodelovanje v študiji nadaljevalo 77% oziroma 61% bolnikov.
English: Liver disease Safety and efficacy data are very limited in liver transplant patients.
Slovenian: Bolezni jeter Podatki o varnosti in učinkovitosti pri bolnikih s presajenimi jetri so zelo omejeni.
English: The effects of tenofovir disoproxil -associated changes in BMD on long-term bone health and future fracture risk are currently unknown (see section 5.1).
Slovenian: Učinki dizoproksiltenofovirata, povezani z MGK, na dolgoročno zdravje kosti in bodoče tveganje za zlom, trenutno niso znani (glejte poglavje 5.1).
English: - evidence of lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1).
Slovenian: - z dokazanim na lamivudin rezistentnim virusom hepatitisa B (glejte poglavji 4.8 in 5.1).
English: Mitochondrial dysfunction following exposure in utero Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Slovenian: Mitohondrijska disfunkcija po izpostavljenosti in utero Nukleozidni in nukleotidni analogi lahko v različnih stopnjah vplivajo na mitohondrijsko funkcijo, kar je najbolj izrazito pri stavudinu, didanozinu in zidovudinu.
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.
Slovenian: Pričakuje se, da se bo priporočeno odmerjanje v daljših časovnih intervalih za bolnike z motnjami v delovanju ledvic odražalo v višjih najvišjih plazemskih koncentracijah in nižjem nivoju Cmin v primerjavi z bolniki z normalno ledvično funkcijo.
English: Gender Limited data on the pharmacokinetics of tenofovir in women indicate no major gender effect.
Slovenian: Manjše število podatkov o farmakokinetiki tenofovirja pri ženskah ne nakazuje na pomembnejše razlike med spoloma.
English: Experience in patients with compensated liver disease at 48 weeks (studies GS-US-174-0102 and GS-US
Slovenian: Izkušnje pri bolnikih s kompenzirano jetrno boleznijo v 48. tednu (študiji GS-US-174-0102 in GS-US
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.
Slovenian: Obstajajo poročila o visoki stopnji virološkega neuspeha in pojavu rezistence, v obeh primerih v zgodnji fazi okužbe z virusom HIV, pri zdravljenju s kombinacijo dizoproksiltenofovirata z lamivudinom in abakavirom kakor tudi z lamivudinom in didanozinom pri odmerjanju enkrat na dan.
English: Haemodialysis patients: 245 mg tenofovir disoproxil may be administered every 7 days following completion of a haemodialysis session*.
Slovenian: Bolniki na hemodializi: 245 mg dizoproksiltenofovirata se lahko daje vsakih 7 dni po končani hemodializi*.
English: The oral bioavailability of tenofovir from tenofovir disoproxil in fasted patients was approximately 25%.
Slovenian: Peroralna biološka razpoložljivost tenofovirja iz dizoproksiltenofovirata je bila približno 25% pri teščih bolnikih.
English: The safety and efficacy of tenofovir disoproxil in HIV-1 infected children or children with chronic hepatitis B under 2 years of age have not been established.
Slovenian: Varnost in učinkovitost dizoproksiltenofovirata pri otrocih, okuženih s HIV-1, ali otrocih s kroničnim hepatitisom B, starih do 2 leti, še nista bili dokazani.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Slovenian: Čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo CART ali obojim.
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).
Slovenian: Po peroralnem vnosu dizoproksiltenofovirata se tenofovir porazdeli po večini tkiv z najvišjo koncentracijo v ledvicah, jetrih in v vsebini črevesja (predklinične študije).
English: Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).
Slovenian: Težave s kostmi (včasih tudi zlom) se lahko pojavijo tudi zaradi okvare celic ledvičnih tubulov (glejte poglavje 4, Možni neželeni učinki).
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.
Slovenian: Bolniki morajo biti poučeni o tem, da zdravljenje z dizoproksiltenofoviratom ne preprečuje tveganja za prenos HBV na druge preko spolnega stika ali okužbe s krvjo.
English: d The population used for analysis of ALT normalisation included only patients with ALT above ULN at baseline.
Slovenian: d V populaciji, ki so jo uporabili za analizo normalizacije ALT, so bili samo bolniki z ravnjo ALT nad ZMN v izhodiščni točki.
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).
Slovenian: V 48. tednu je šest mladostnikov v skupini z dizoproksiltenofoviratom in en mladostnik v skupini s placebom doživelo znatno izgubo MGK ledvene hrbtenice (opredeljeno kot izguba > 4%).
English: No data are available to make dose recommendations (see sections 4.2 and 4.4).
Slovenian: Ni podatkov, ki bi omogočili priporočila glede odmerka (glejte poglavji 4.2 in 4.4).
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.
Slovenian: Zato se sme pri odraslih bolnikih z ledvično okvaro dizoproksiltenofovirat uporabljati samo, če se oceni, da morebitne koristi zdravljenja odtehtajo morebitna tveganja.
English: Forty-nine of the 51 nucleoside-experienced patients were previously treated with lamivudine.
Slovenian: 49 od 51 bolnikov, zdravljenih z nukleozidi, je predhodno prejemalo lamivudin.
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.
Slovenian: • Če ste ženska, okužena z virusom HIV ali HBV, ne dojite, da s tem preprečite prenos virusa preko mleka na dojenčka.
English: Forty-three percent of patients had baseline viral loads > 100,000 copies/ml and 39% had CD4 cell counts < 200 cells/ml.
Slovenian: 43 % bolnikov je imelo začetno vrednost virusne obremenitve > 100.000 kopij/ml in 39 % je imelo število CD4 celic < 200 celic/ml.
English: For dosage see section 3, How to take Tenofovir disoproxil Zentiva.
Slovenian: Za odmerjanje glejte poglavje 3, Kako jemati zdravilo Dizoproksiltenofovirat Zentiva.
English: Tenofovir disoproxil Zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva je indicirano v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje odraslih, okuženih s HIV-1.
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.
Slovenian: Ta neželeni učinek je bil opredeljen v okviru nadzora v obdobju trženja zdravila, vendar ga v randomiziranih kontroliranih kliničnih študijah ali v podaljšanem programu dostopanja do dizoproksiltenofovirata niso opazili.