FrancophonIA/ELRC3.0 huggingface dataset:
English: Stopping treatment with Tenofovir disoproxil Mylan may reduce the effectiveness of the treatment recommended by your doctor.
Slovenian: Prenehanje zdravljenja z zdravilom Dizoproksiltenofovirat Mylan lahko zmanjša učinkovitost zdravljenja, ki vam ga je predpisal zdravnik.
English: If you are allergic to tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine listed in section 6.
Slovenian: • Če ste alergični na tenofovir, dizoproksiltenofovirat ali katero koli sestavino tega zdravila navedeno v poglavju 6.
English: Tenofovir disoproxil must be taken with food, as food enhances the bioavailability of tenofovir (see section 5.2).
Slovenian: Dizoproksiltenofovirat je treba jemati s hrano, kajti hrana poviša biološko uporabnost tenofovirja (glejte poglavje 5.2).
English: If you are older than this and are prescribed Tenofovir disoproxil Mylan, your doctor will monitor you carefully.
Slovenian: Če ste starejši in so vam predpisali zdravilo Dizoproksiltenofovirat Mylan, vas bo zdravnik skrbno nadzoroval.
English: In vitro studies have determined that neither tenofovir disoproxil nor tenofovir are substrates for the CYP450 enzymes.
Slovenian: In vitro študije so pokazale, da niti dizoproksiltenofovirat niti tenofovir nista substrata za encime CYP450.
English: The K65R mutation occurred in a slightly higher percentage of patients in the tenofovir disoproxil group than the active control group (2.7% versus 0.7%).
Slovenian: Mutacija K65R se je pojavila pri bolnikih v skupini z dizoproksiltenofoviratom v rahlo zvišanem odstotku kot pri aktivni kontrolni skupini (2,7% proti 0,7%).
English: Comparisons between treatment groups beyond week 24 are difficult to interpret since investigators had the option to intensify treatment to open-label emtricitabine plus tenofovir disoproxil.
Slovenian: Primerjave med skupinami zdravljenja po 24. tednu je bilo težko razlagati, ker so imeli raziskovalci na voljo možnost stopnjevati zdravljenje v odprto zdravljenje z emtricitabinom in dizoproksiltenofoviratom.
English: At weeks 96, 144, 192, 240, 288 and 384 viral suppression, biochemical and serological responses were maintained with continued tenofovir disoproxil treatment (see Tables 4 and 5 below).
Slovenian: V 96., 144., 192., 240., 288. in 384. tednu so bili virusna supresija ter biokemični in serološki odzivi ohranjeni pri neprekinjenem zdravljenju z dizoproksiltenofoviratom (glejte preglednici 4 in 5 spodaj).
English: If you have a history of liver disease or chronic hepatitis B infection your doctor may conduct blood tests to monitor your liver function.
Slovenian: Če ste imeli jetrne bolezni ali imate okužbo s kroničnim hepatitisom B, bo zdravnik morda opravil krvne preiskave za nadzorovanje jetrne funkcije.
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:
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo Dizoproksiltenofovirat Mylan pri bolnikih, starih od 12 do < 18 let, prejeli izobraževalni paket za zdravnika, ki bo vseboval Povzetek glavnih značilnosti zdravila in primerne izobraževalne brošure, kot je navedeno v nadaljevanju:
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil in randomised controlled clinical trials and the expanded access program (n = 7,319).
Slovenian: Kategorija pogostnosti je bila ocenjena s statističnim izračunom na podlagi skupnega števila bolnikov, izpostavljenih dizoproksiltenofoviratu v randomiziranih kontroliranih kliničnih študijah in podaljšanem programa dostopanja (n = 7 319).
English: Mylan Hungary Kft Mylan utca 1, Komarom, 2900, Hungary
Slovenian: Mylan Hungary Kft Mylan utca 1, Komarom, 2900, Madžarska
English: OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (Z MODRIM OKENCEM)
English: Pharmacotherapeutic group: Antiviral for systemic use; nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF07.
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij; nukleozidni in nukleotidni zaviralci reverzne transkriptaze, oznaka ATC: J05AF07
English: • damage to kidney tubule cells
Slovenian: • okvara celic ledvičnih tubulov
English: Do not reduce the prescribed dose, unless your doctor has told you to do so.
Slovenian: Predpisanega odmerka ne zmanjšajte, če vam tega ne naroči zdravnik.
English: Other medicines and Tenofovir disoproxil Mylan Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Dizoproksiltenofovirat Mylan Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with tenofovir disoproxil in one or more subsets of the paediatric population in HIV and chronic hepatitis B (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z dizoproksiltenofoviratom za eno ali več podskupin pediatrične populacije za virus HIV in kronični hepatitis B (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Reproductive studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Slovenian: Študije o vplivu na sposobnost razmnoževanja na podganah in kuncih niso pokazale učinkov na parjenje, plodnost, nosečnost ali plod.
English: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 mL/min/1.73 m2.
Slovenian: Sedem bolnikov je imelo ocenjen nivo hitrosti glomerularne filtracije (GFR) med 70 in 90 ml/min/1,73 m2.
English: INNER CARTON OF MULTIPACK AND BOTTLE LABEL (WITHOUT BLUE BOX)
Slovenian: NOTRANJA ŠKATLA SKUPNEGA PAKIRANJA IN NALEPKA ZA PLASTENKO (BREZ MODREGA OKENCA)
English: HBV DNA n (%) < 400 copies/ml n (%)
Slovenian: HBV DNA n (%) < 400 kopij/ml n (%)
English: • Other medicines containing didanosine (for HIV infection): Taking Tenofovir disoproxil Mylan with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Slovenian: • Druga zdravila, ki vsebujejo didanozin (za okužbe z virusom HIV): Jemanje zdravila Dizoproksiltenofovirat Mylan skupaj z drugimi protivirusnimi zdravili, ki vsebujejo didanozin, lahko zviša ravni didanozina v krvi in zmanjša število celic CD4.
English: Following intravenous administration the steady-state volume of distribution of tenofovir was estimated to be approximately 800 ml/kg.
Slovenian: Po intravenskem odmerku je volumen porazdelitve tenofovirja v stanju dinamičnega ravnovesja znašal po ocenah približno 800 ml/kg.
English: Simulations suggest that the prolonged dose interval using tenofovir disoproxil 245 mg film-coated tablets is not optimal and could result in increased toxicity and possibly inadequate response.
Slovenian: Simulacije nakazujejo, da podaljšani odmerni interval z 245 mg filmsko obloženimi tabletami dizoproksiltenofovirata ni optimalen in lahko vodi v povečano toksičnost in možnost nezadostnega odziva.
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).
Slovenian: Toksičen vpliv na kosti pri mladih odraslih podganah in psih se je pojavil pri ≥ 5-kratni izpostavljenosti za pediatrične ali odrasle bolnike; toksičen vpliv na kosti se je pojavil pri mladih okuženih opicah pri zelo visokih izpostavljenostih po subkutanemu dajanju (≥ 40-kratna izpostavljenost pri bolnikih).
English: Interactions between tenofovir disoproxil and other medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”, and once daily as “q.d.”).
Slovenian: Interakcije med dizoproksiltenofoviratom in drugimi zdravili so navedene v preglednici 1 spodaj (povečanje je označeno z znakom “↑”, zmanjšanje z “↓”, brez spremembe z “↔”, dvakrat na dan z “b.i.d”, enkrat na dan pa s “q.d.”).
English: Lactose monohydrate Titanium dioxide (E171) Triacetin
Slovenian: Filmska obloga hipromeloza laktoza monohidrat titanov dioksid (E171) triacetin indigotin (E132)
English: • tacrolimus (for suppression of the immune system),
Slovenian: • takrolimus (za zaviranje imunskega sistema);
English: Mylan Hungary Kft Mylan utca 1, Komarom, H-2900, Hungary
Slovenian: Mylan Hungary Kft Mylan utca 1, Komarom, H-2900, Madžarska
English: The effects of tenofovir disoproxilassociated 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: Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Slovenian: Tenofovir se primarno izloča preko ledvic tako s filtracijo kot z aktivnim tubularnim transportnim sistemom, pri čemer se po intravenoznem vnosu približno 70 - 80% odmerka izloči nespremenjenega s sečem.
English: • You must not take Tenofovir disoproxil Mylan during pregnancy unless specifically discussed with your doctor.
Slovenian: • Zdravila Dizoproksiltenofovirat Mylanne smete jemati med nosečnostjo, razen če ste se o tem posebej dogovorili s svojim zdravnikom.
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.
Slovenian: Če ste v času zdravljenja z zdravilom Dizoproksiltenofovirat Mylan omotični, ne vozite avtomobila ali kolesa in ne upravljajte z orodji ali stroji.
English: Renal and bone effects in paediatric population
Slovenian: Učinki na ledvice in kosti pri pediatrični populaciji
English: (log10 copies/ml) HBV DNA (%)
Slovenian: (log10 kopij/ml) HBV DNA
English: Look out for signs of inflammation or infection soon after you start taking Tenofovir disoproxil Mylan.
Slovenian: Bodite pozorni na simptome vnetja ali okužbe kmalu po začetku jemanja zdravila Dizoproksiltenofovirat Mylan.
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping tenofovir disoproxil.
Slovenian: Krvne preiskave ali simptomi pri nekaterih bolnikih so kazali, da se je njihov hepatitis poslabšal po prenehanju zdravljenja z dizoproksiltenofoviratom.
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Študije o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
English: • Not for HIV-1 infected children under 12 years of age
Slovenian: • ni za otroke, okužene s HIV-1, mlajše od 12 let;
English: Severe renal impairment: 245 mg tenofovir disoproxil may be administered every 72-96 hours (dosing twice a week).
Slovenian: Huda ledvična okvara: 245 mg dizoproksiltenofovirata vsakih 72 - 96 ur (odmerjanje dvakrat na teden).
English: Administration of tenofovir disoproxil with a high fat meal enhanced the oral bioavailability, with an increase in tenofovir AUC by approximately 40% and Cmax by approximately 14%.
Slovenian: Jemanje dizoproksiltenofovirata z z maščobami bogatim obrokom je povečalo peroralno biološko uporabnost, s povečanjem AUC tenofovirja za približno 40% in Cmax za približno 14%.
English: There are uncertainties associated with the long term effects of bone and renal toxicity.
Slovenian: V povezavi z dolgoročnimi toksičnimi učinki na kosti in ledvice obstajajo negotovosti.
English: If this applies to you, tell your doctor immediately and do not take Tenofovir disoproxil Mylan.
Slovenian: Če to velja za vas, o tem nemudoma obvestite zdravnika in ne jemljite zdravila Dizoproksiltenofovirat Mylan.
English: Complete response a
Slovenian: Popolni odziv a
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
Slovenian: Kaj je zdravilo Dizoproksiltenofovirat Mylan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Dizoproksiltenofovirat Mylan Kako jemati zdravilo Dizoproksiltenofovirat Mylan Možni neželeni učinki
English: Tenofovir shows activity in vitro against HIV-2, with an EC50 of 4.9 µmol/l in MT-4 cells.
Slovenian: Tenofovir kaže in vitro aktivnost proti HIV-2 z EC50 4,9 µmol/l v MT-4 celicah.
English: If you think that you may have any of these serious side effects, talk to your doctor.
Slovenian: Če menite, da bi lahko imeli katerega koli od teh resnih neželenih učinkov, se posvetujte z zdravnikom.
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.
Slovenian: • da lahko zdravilo Dizoproksiltenofovirat Mylan povzroči zmanjšanje MGK in da učinki zdravila Dizoproksiltenofovirat Mylan, povezani z MGK, na dolgoročno zdravje kosti in bodoče tveganje za zlom, pri bolnikih, starih od 12 do < 18 let, trenutno niso znani;
English: • inflammation of the kidney, passing a lot of urine and feeling thirsty
Slovenian: • vnetje ledvic, izločanje večjih količin urina in občutek žeje
English: acute renal failure, renal failure, acute tubular necrosis, nephritis (including acute interstitial nephritis)
Slovenian: akutna ledvična odpoved, ledvična odpoved, akutna tubularna nekroza, nefritis (vključno z akutnim intersticijskim nefritisom)
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Slovenian: Bolniki s predobstoječo jetrno disfunkcijo, vključno s kroničnim aktivnim hepatitisom, imajo v času kombinirane protiretrovirusne terapije (CART, combination antiretroviral therapy) več anomalij jetrne funkcije in jih je treba nadzirati v skladu s standardno prakso.
English: Danmark BGP Products ApS Tlf: + 45 28116932
Slovenian: BGP Products ApS Tlf: + 45 28116932
English: • If you are an adult and have problems with your kidneys, your doctor may advise you to take Tenofovir disoproxil Mylan less frequently.
Slovenian: • Če ste odrasla oseba in imate ledvične težave, vam bo zdravnik morda svetoval, da jemljete zdravilo Dizoproksiltenofovirat Mylan manj pogosto.
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).
Slovenian: Če ste vzeli večji odmerek zdravila Dizoproksiltenofovirat Mylan, kot bi smeli Če ste pomotoma zaužili preveč tablet zdravila Dizoproksiltenofovirat Mylan, se lahko poveča tveganje pojava možnih neželenih učinkov povezanih s tem zdravilom (glejte poglavje 4, Možni neželeni učinki).
English: The safety and efficacy of tenofovir disoproxil in children with chronic hepatitis B aged 2 to < 12 years or weighing < 35 kg have not been established.
Slovenian: Varnost in učinkovitost dizoproksiltenofovirata pri otrocih s kroničnim hepatitisom B, starih 2 leti do < 12 let ali s telesno maso < 35 kg, nista bili dokazani.
English: BMD Z-scores were not adjusted for height and weight.
Slovenian: Z-indeksi MGK niso bili prilagojeni telesni višini in masi.
English: Co-infection with hepatitis C or D: There are no data on the efficacy of tenofovir in patients coinfected 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: 10 film-coated tablets 30 film-coated tablets 30 x 1 film-coated tablets
Slovenian: filmsko obložena tableta 10 filmsko obloženih tablet 30 filmsko obloženih tablet 30 x 1 filmsko obložena tableta
English: Microcrystalline cellulose Lactose monohydrate Hydroxypropylcellulose, low substituted Silica, colloidal anhydrous Magnesium stearate
Slovenian: Jedro tablete mikrokristalna celuloza laktoza monohidrat hidroksipropilceluloza, nizkosubstituirana brezvodni koloidni silicijev dioksid magnezijev stearat
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 od izoform CYP450, izjema je CYP1A1/2, kjer so opazili majhno (6%) toda statistično značilno zmanjšanje presnove substrata za CYP1A1/2.
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: • decompensated liver disease (see sections 4.4, 4.8 and 5.1).
Slovenian: • z dekompenzirano jetrno boleznijo (glejte poglavja 4.4, 4.8 in 5.1).
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: 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: 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: • foscarnet, ganciclovir, or cidofovir (for viral infection),
Slovenian: • foskarnet, ganciklovir ali cidofovir (za virusno okužbo);
English: However, tenofovir disoproxil reduced the viability index and weight of pups in peripostnatal toxicity studies at maternally toxic doses.
Slovenian: Vendar pa je dizoproksiltenofovirat zmanjšal indeks življenjskih funkcij in težo mladičkov v peri- in postnatalnih študijah toksičnosti pri odmerkih, toksičnih za mater.
English: The combination should be used with caution with frequent renal monitoring, if other alternatives are not available (see section 4.4).
Slovenian: Komibacijo je treba uporabljati previdno s pogostim nadzorom ledvic, če drugih alternativ ni na voljo (glejte poglavje 4.4).
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: • softening of the bones (with bone pain and sometimes resulting in fractures), which may occur due to damage to kidney tubule cells
Slovenian: • mehčanje kosti (z bolečinami v kosteh, včasih tudi zlom), ki se lahko pojavijo zaradi okvare celic ledvičnih tubulov
English: If you have hepatitis B or HIV and hepatitis B together (co-infection), it is very important not to stop your Tenofovir disoproxil Mylan 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 Mylan, ne da bi se prej posvetovali z zdravnikom.
English: Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Slovenian: Rezultati študij, izvedenih na podganah in opicah, so pokazali z učinkovino povezano zmanjšanje absorpcije fosfata v črevesju s potencialnim sekundarnim zmanjšanjem MGK.
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
Slovenian: • da obstaja povečano tveganje za nastanek ledvične bolezni pri bolnikih, okuženih HIV in HBV, povezano z zdravili, ki vsebujejo dizoproksiltenofovirat, kot je zdravilo Dizoproksiltenofovirat Mylan;
English: • aminoglycosides, pentamidine or vancomycin (for bacterial infection),
Slovenian: • aminoglikozidi, pentamidin ali vankomicin (za bakterijsko okužbo);
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 vključevale ali M41L ali L210W mutacijo reverzne transkriptaze, kazali zmanjšan odziv na zdravljenje z 245 mg dizoproksiltenofovirata.
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: 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).
Slovenian: Ker lahko dizoproksiltenofovirat povzroči ledvično poškodbo, se priporoča nadziranje ledvične funkcije (glejte poglavji 4.4 in 4.8 Povzetek varnostnega profila).
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: • 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
Slovenian: • mladostnike, okužene s HIV-1, stare od 12 do manj kot 18 let, s telesno maso vsaj 35 kg, ki so se predhodno že zdravili z drugimi zdravili proti HIV, ki niso več polno učinkovita zaradi nastanka odpornosti ali so povzročala neželene učinke;