FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: - Pri HBeAg pozitivnih bolnikih brez ciroze naj zdravljenje traja najmanj 6- 12 mesecev po potrditvi HBe serološke konverzije (izguba HBeAg in izguba HBV DNA z detekcijo anti-HBe) ali do HBs serološke konverzije ali dokler ne pride do izgube učinkovitosti (glejte poglavje 4.4).
English: • That a multidisciplinary approach is recommended for the management of patients aged 12 to < 18 years
Slovenian: • da je za obravnavo bolnikov, starih od 12 do < 18 let, potreben multidisciplinarni pristop;
English: Your doctor may order blood tests during treatment to monitor how your kidneys work.
Slovenian: Zdravnik bo morda naredil krvne preiskave v času zdravljenja, da bo nadzoroval delovanje vaših ledvic.
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).
Slovenian: - Druge sestavine zdravila so mikrokristalna celuloza, laktoza monohidrat (glejte poglavje 2, Zdravilo Dizoproksiltenofovirat Mylan vsebuje laktozo), hidroksipropilceluloza, koloidni brezvodni silicijev dioksid, magnezijev stearat, hipromeloza, titanov dioksid (E171), triacetin in barvilo indigotin (E132).
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.
Slovenian: V izjemnih primerih pa se lahko zdravilo Dizoproksiltenofovirat Mylan 245 mg filmsko obložene tablete zaužije razdrobljeno v najmanj 100 ml vode, pomarančnega ali grozdnega soka.
English: Eight (2%) tenofovir disoproxil 245 mg treated patients developed the K65R mutation within the first 48 weeks.
Slovenian: Osem (2%) bolnikov, zdravljenih z 245 mg dizoproksiltenofovirata, je razvilo mutacijo K65R v teku prvih 48 tednov.
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.
Slovenian: Priporočen odmerek dizoproksiltenofovirata za zdravljenje okužbe z virusom HIV ali za zdravljenje kroničnega hepatitisa B je 245 mg (ena tableta) enkrat dnevno, peroralno, skupaj s hrano.
English: Tenofovir disoproxil Mylan tablets should be taken once daily, orally with food.
Slovenian: Način uporabe Tablete Dizoproksiltenofovirat Mylan se jemljejo enkrat dnevno, peroralno, skupaj s hrano.
English: • Adolescents aged 12 to less than 18 years who weigh at least 35 kg: 1 tablet each day with food (for example, a meal or a snack).
Slovenian: • mladostniki, stari od 12 do manj kot 18 let, s telesno maso vsaj 35 kg: 1 tableta vsak dan s hrano (na primer ob obroku ali prigrizku).
English: While taking Tenofovir disoproxil Mylan you may still develop infections or other illnesses associated with HIV infection.
Slovenian: Med jemanjem zdravila Dizoproksiltenofovirat Mylan se lahko še naprej razvijejo okužbe ali druge bolezni, povezane z okužbo s HIV.
English: Moderate renal impairment (creatinine clearance 30-49 ml/min) Since administration of a lower dose with the 245 mg tablet is not possible, prolonged dose intervals using the 245 mg film-coated tablets may be used.
Slovenian: Zmerna ledvična okvara (očistek kreatinina od 30 - 49 ml/min) Ker uporaba manjšega odmerka z 245 mg tableto ni možna, se lahko uporabijo podaljšani odmerni intervali z 245 mg filmsko obloženimi tabletami.
English: Tolerability failure (permanent discontinuation of study drug due to a treatment emergent AE)
Slovenian: tolerančna napaka (trajna prekinitev zdravljenja s študijskim zdravilom zaradi neželenega učinka, povezanega z zdravljenjem) n (%)
English: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in adult patients with renal impairment treated with Tenofovir disoproxil Mylan (see sections 4.2, 4.4 and 5.2).
Slovenian: Ker lahko dizoproksiltenofovirat povzroči ledvično toksičnost, se priporoča skrbno nadziranje ledvične funkcije pri odraslih bolnikih z ledvično okvaro, ki se zdravijo z zdravilom Dizoproksiltenofovirat Mylan (glejte poglavja 4.2, 4.4 in 5.2).
English: If a patient misses a dose of tenofovir disoproxil within 12 hours of the time it is usually taken, the patient should take tenofovir disoproxil with food as soon as possible and resume their normal dosing schedule.
Slovenian: Če bolnik izpusti odmerek dizoproksiltenofovirata v roku 12 ur od časa, ko ga običajno vzame, naj bolnik vzame dizoproksiltenofovirat s hrano takoj, ko je mogoče, nato pa nadaljuje s svojim običajnim režimom odmerjanja.
English: The HIV and HBV patients aged 12 to < 18 years educational brochures should contain the following key messages:
Slovenian: Izobraževalni brošuri o bolnikih, starih od 12 do < 18 let, s HIV in HBV morata vsebovati naslednja ključna sporočila:
English: You do not need to take another tablet if you were sick more than 1 hour after taking Tenofovir disoproxil Mylan
Slovenian: Še ene tablete vam ni treba vzeti, če ste bruhali več kot 1 uro po zaužitju zdravila Dizoproksiltenofovirat Mylan.
English: As Tenofovir disoproxil Mylan is available only as 245 mg film-coated tablets, it is not suitable for the use in paediatric patients aged 2 to < 12 years.
Slovenian: Ker je zdravilo Dizoproksiltenofovirat Mylan na voljo samo v obliki 245 mg filmsko obloženih tablet, ni primerno za uporabo pri prediatričnih bolnikih, starih 2 do < 12 let.
English: If a patient misses a dose of tenofovir disoproxil by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
Slovenian: Če bolnik izpusti odmerek dizoproksiltenofovirata za več kot 12 ur in je že skoraj čas za naslednji odmerek, naj bolnik ne nadomesti izpuščenega odmerka in preprosto nadaljuje z jemanjem po običajnem režimu odmerjanja.
English: If you have particular difficulty swallowing, you can use the tip of a spoon to crush the tablet.
Slovenian: Če imate težave s požiranjem, lahko tableto zdrobite s konico žlice.
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 poročali o primerih osteonekroze, zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo CART ali obojim.
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
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: In studies GS-US-174-0102 and GS-US174-0103, 77% and 61% of patients continued in the study through to 384 weeks, respectively.
Slovenian: V študijah GS-US-174-0102 in GS-US-174-0103 je do 384. tedna sodelovanje v študiji nadaljevalo 77% oziroma 61% bolnikov.
English: EXP After first opening use within 90 days
Slovenian: EXP Po prvem odprtju uporabite v 90 dneh.
English: In HIV Tenofovir disoproxil Mylan should always be used combined with other medicines to treat HIV infection.
Slovenian: Zdravilo Dizoproksiltenofovirat Mylan je treba vedno uporabljati v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV.
English: In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected by tenofovir and results in low-level reduced susceptibility to tenofovir.
Slovenian: Poleg tega je substitucija K70E reverzne transkriptaze HIV-1, ki se je razvila s tenofovirjem, povzročila zmanjšano občutljivost za tenofovir.
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: HIV antiviral activity in vitro: The concentration of tenofovir required for 50% inhibition (EC50) of the wild-type laboratory strain HIV-1IIIB is 1-6 µmol/l in lymphoid cell lines and 1.1 µmol/l against primary HIV-1 subtype B isolates in PBMCs.
Slovenian: Protivirusna aktivnost proti virusu HIV in vitro: 50% inhibitorna koncentracija (EC50) tenofovirja za divji tip laboratorijskega seva HIV-1IIIB znaša 1-6 µmol/l v limfoidnih celičnih linijah in EC50 za primarne izolate HIV-1 podtipa B je 1,1 µmol/l v PBMC.
English: For dosage see section 3, How to take Tenofovir disoproxil Mylan.
Slovenian: Za odmerjanje glejte poglavje 3 Kako jemati zdravilo Dizoproksiltenofovirat Mylan.
English: HIV-1: Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg.
Slovenian: HIV-1: Farmakokinetiko tenofovirja v stanju dinamičnega ravnovesja so ovrednotili pri 8 mladostnikih, okuženih z virusom HIV-1 (starih 12 do < 18 let) s telesno maso ≥ 35 kg.
English: Although there are limited clinical data on the use of tenofovir disoproxil in pregnant women, it is not usually used unless absolutely necessary.
Slovenian: Čeprav je na voljo nekaj kliničnih podatkov o uporabi zdravila Dizoproksiltenofovirat Mylan pri nosečnicah, se zdravila Dizoproksiltenofovirat Mylan ponavadi ne uporablja, razen če je nujno potrebno.
English: Tenofovir disoproxil Mylan does not reduce the risk of passing on HBV to others through sexual contact or blood contamination.
Slovenian: Zdravilo Dizoproksiltenofovirat Mylan ne zmanjšuje nevarnosti prenosa virusa HBV na druge s spolnim stikom ali okužbo s krvjo.
English: Acute exacerbation of hepatitis has been reported in patients on treatment as well as in patients who have discontinued hepatitis B therapy (see section 4.4).
Slovenian: O akutnem poslabšanju hepatitisa so poročali tako pri bolnikih, ki so se zdravili, kot pri bolnikih, ki so prekinili zdravljenje hepatitisa B (glejte poglavje 4.4).
English: You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.
Slovenian: lahko prenesete tudi na druge, zato je pomembno, da uporabljate zaščitne ukrepe, ki preprečujejo okužbo drugih oseb.
English: 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: Cumulatively, there were 4 patients who experienced a viremic episode (HBV DNA>400 copies/ml) at their last timepoint on tenofovir disoproxil.
Slovenian: Kumulativno so bili 4 bolniki, ki so imeli viremično epizodo (HBV DNA > 400 kopij/ml) ob zadnji časovni točki zdravljeni z dizoproksiltenofoviratom.
English: • That Tenofovir disoproxil Mylan is not recommended for use in patients aged 12 to < 18 years with renal impairment
Slovenian: • da zdravilo Dizoproksiltenofovirat Mylan ni priporočljivo za uporabo pri bolnikih, starih od 12 do < 18 let, z ledvično okvaro;
English: • Talk to your doctor before you stop taking Tenofovir disoproxil Mylan for any reason, particularly if you are experiencing any side effects or you have another illness.
Slovenian: • Preden prenehate jemati zdravilo Dizoproksiltenofovirat Mylan iz katerega koli razloga, se pogovorite z zdravnikom, še zlasti če imate kakršne koli neželene učinke ali kakšno drugo bolezen.
English: Do not take Tenofovir disoproxil Mylan together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
Slovenian: Ne jemljite zdravila Dizoproksiltenofovirat Mylan skupaj z zdravili, ki vsebujejo dipivoksiladefovirat (zdravilo, ki se uporablja za zdravljenje kroničnega hepatitisa B).
English: • changes to your urine and back pain caused by kidney problems, including kidney failure
Slovenian: • spremembe urina in bolečine v križu zaradi motenj v delovanju ledvic, vključno z odpovedjo ledvic
English: Mean (± SD) Cmax and AUCtau are 0.38 ± 0.13 μg/ml and 3.39 ± 1.22 μg·h/ml, respectively.
Slovenian: Povprečni (± SD) Cmax je bil 0,38 ± 0,13 μg/ml in povprečni AUCtau 3,39 ± 1,22 μg·h/ml.
English: The oral bioavailability of tenofovir from tenofovir disoproxil in fasted patients was approximately 25%.
Slovenian: Peroralna biološka uporabnost tenofovirja iz dizoproksiltenofovirata je bila približno 25% pri teščih bolnikih.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactataemia, hyperlipasaemia).
Slovenian: Glavni opisani neželeni učinki so hematološke motnje (anemija, nevtropenija), in presnovne motnje (hiperlaktatemija, hiperlipazemija).
English: Long-term studies to evaluate the benefit/risk of bitherapy with emtricitabine plus tenofovir disoproxil in HBV monoinfected patients are ongoing.
Slovenian: Dolgoročne študije za ocenitev koristi in tveganj dvojnega zdravljenja z emtricitabinom in dizoproksiltenofoviratom pri bolnikih, okuženih samo s HBV, še potekajo.
English: The active substance tenofovir disoproxil and its main transformation products are persistent in the environment.
Slovenian: Učinkovina dizoproksiltenofovirat in njeni glavni presnovki so v okolju obstojni.
English: If tenofovir disoproxil is discontinued in patients with chronic hepatitis B with or without HIV coinfection, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Slovenian: Če se jemanje dizoproksiltenofovirata prekine pri bolnikih s kroničnim hepatitisom B s sočasno okužbo z virusom HIV ali brez nje, je treba pri teh bolnikih skrbno nadzorovati znake poslabšanja hepatitisa (glejte poglavje 4.4).
English: • adults
Slovenian: • odrasle;
English: Tenofovir disoproxil may cause a reduction in BMD.
Slovenian: Dizoproksiltenofovirat lahko povzroči zmanjšanje MGK.
English: Administration of 245 mg tenofovir disoproxil every 48 hours can be used based on modelling of single-dose pharmacokinetic data in HIV negative and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring haemodialysis, but has not been confirmed in clinical studies.
Slovenian: Uporabi se lahko odmerek 245 mg dizoproksiltenofovirata vsakih 48 ur, ki temelji na podatkih farmakokinetičnega modeliranja enkratnih odmerkov pri bolnikih, ki so HIV-negativni in niso okuženi z virusom HBV, z različnimi stopnjami ledvične okvare, vključno s končno fazo ledvične bolezni, zaradi katere je potrebna hemodializa, toda v kliničnih študijah ni bil potrjen.
English: <For inner carton of multipack:> Component of a multipack, can't be sold separately.
Slovenian: 30 filmsko obloženih tablet <za notranjo škatlo skupnega pakiranja> Sestavni del skupnega pakiranja, ni za ločeno prodajo.
English: There are limited data on the safety and efficacy of tenofovir disoproxil in adult patients with moderate and severe renal impairment (creatinine clearance < 50 ml/min) and long-term safety data has not been evaluated for mild renal impairment (creatinine clearance 50-80 ml/min).
Slovenian: Podatki o varnosti in učinkovitosti dizoproksiltenofovirata pri odraslih bolnikih z zmerno in hudo ledvično okvaro (očistek kreatinina < 50 ml/min) so nezadostni, dolgoročni podatki o varnosti pri bolnikih z blago ledvično okvaro (očistek kreatinina 50-80 ml/min) niso bili ovrednoteni.
English: Tenofovir disoproxil Mylan is not usually taken with other medicines that can damage your kidneys (see Other medicines and Tenofovir disoproxil Mylan).
Slovenian: Zdravila Dizoproksiltenofovirat Mylan se ponavadi ne jemlje z drugimi zdravili, ki bi lahko poškodovala ledvice (glejte Druga zdravila in zdravilo Dizoproksiltenofovirat Mylan).
English: • HBV infected adolescents aged 12 to less than 18 years who weigh at least 35 kg.
Slovenian: • mladostnike, okužene s HBV, stare od 12 do manj kot 18 let, s telesno maso vsaj 35 kg.
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
Slovenian: Naslednji neželeni učinki so zelo pogosti (pojavijo se lahko pri več kot 10 od 100 bolnikov): • driska, bruhanje, občutek siljenja na bruhanje, omotičnost, izpuščaj, občutek oslabelosti
English: High density polyethylene (HDPE) bottle with polypropylene (PP) child resistant closure with wad containing aluminium induction sealing liner and desiccant (silica gel), available in the following pack sizes: 30 film-coated tablets and multipacks containing 90 (3 packs of 30) film-coated tablets.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE) s polipropilensko (PP), za otroke varno zaporko z blazinico, ki vsebuje aluminijev tesnilni trak in sušilno sredstvo (silikagel), in ki je na voljo v naslednjih velikostih pakiranj: 30 filmsko obloženih tablet in skupna pakiranja, ki vsebujejo 90 (3 škatle po 30) filmsko obloženih tablet.
English: Subjects must have been naïve to tenofovir disoproxil, but could have received interferon based regimens (> 6 months prior to screening) or any other non-tenofovir disoproxil containing oral anti-HBV nucleoside/nucleotide therapy (> 16 weeks prior to screening).
Slovenian: Bolniki so morali biti predhodno še nezdravljeni z dizoproksiltenofoviratom, lahko pa so prejemali režime na osnovi interferona (> 6 mesecev pred presejanjem) ali katero koli drugo peroralno nukleozidno/nukleotidno zdravilo proti virusu HBV, ki ni vsebovalo dizoproksiltenofovirata (> 16 tednov pred presejanjem).
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.
Slovenian: To zdravilo je na voljo v plastenkah z za otroke varno zaporko in blazinico, ki vsebujejo 30 filmsko obloženih tablet, in v skupnih pakiranjih z 90 filmsko obloženimi tabletami, ki vsebujejo 3 plastenke s 30 filmsko obloženimi tabletami.
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.
Slovenian: Ocenjeno je, da znaša skupni očistek približno 230 ml/h/kg (približno 300 ml/min), ledvični očistek je približno 160 ml/h/kg (približno 210 ml/min), kar presega nivo glomerularne filtracije.
English: This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical trials or the tenofovir disoproxil expanded access program.
Slovenian: 2 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.
English: In studies with nucleoside-naïve patients, on-treatment ALT elevations > 10 times ULN (upper limit of normal) and > 2 times baseline occurred in 2.6% of tenofovir disoproxil-treated patients.
Slovenian: V študijah pri bolnikih, ki še niso bili zdravljeni z nukleozidi, so se zvišanja ALT med zdravljenjem za > 10-kratno vrednost ZMN (zgornje meje normalne vrednosti) in > 2-kratno vrednost izhodiščne vrednosti pojavila pri 2,6% bolnikov, zdravljenih z dizoproksiltenofoviratom.
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 10 or 30 film coated tablets.
Slovenian: OPA/aluminij/PE/sušilno sredstvo/PE-aluminijevi pretisni omoti, ki vsebujejo 10 ali 30 filmsko obloženih tablet.
English: Reductions in BMD have been observed in HBV infected adolescents.
Slovenian: Poročali so o zmanjšanju MGK pri mladostnikih, okuženih s HBV.
English: Tenofovir disoproxil has not been clinically evaluated in patients receiving medicinal products which are secreted by the same renal pathway, including the transport proteins human organic anion transporter (hOAT) 1 and 3 or MRP 4 (e.g. cidofovir, a known nephrotoxic medicinal product).
Slovenian: Uporaba dizoproksiltenofovirata klinično ni bila ovrednotena pri bolnikih, ki so prejemali zdravila, ki se izločajo po isti ledvični metabolni poti, vključno s transportnimi beljakovinami hOAT (human organic anion transporter) 1 in 3 ali MRP 4 (npr. cidofovir, znano nefrotoksičeno zdravilo).
English: • compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis (see sections 4.4, 4.8 and 5.1).
Slovenian: • s kompenzirano jetrno boleznijo in dokazano aktivno imunsko boleznijo, tj. aktivno replikacijo virusov, persistentno zvišano vrednostjo ALT v serumu ter histološko dokazanim aktivnim vnetjem in/ali fibrozo (glejte poglavja 4.4, 4.8 in 5.1).
English: Following the first dose of tenofovir disoproxil in fed patients, the median Cmax in serum ranged from 213 to 375 ng/ml.
Slovenian: Po vnosu prvega odmerka dizoproksiltenofovirata je mediana vrednost Cmax v serumu pri sitih bolnikih znašala od 213 do 375 ng/ml.
English: What you need to know before you take Tenofovir disoproxil Mylan
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Dizoproksiltenofovirat Mylan
English: Interrupting treatment with Tenofovir disoproxil Mylan should also be considered in case of progressive decline of renal function when no other cause has been identified.
Slovenian: O prekinitvi zdravljenja z zdravilom Dizoproksiltenofovirat Mylan je treba razmisliti tudi v primeru progresivnega upada ledvične funkcije, če ni bil ugotovljen noben drug razlog;
English: • The importance of regular monitoring of renal function during Tenofovir disoproxil Mylan therapy
Slovenian: • pomembnost rednega nadzorovanja delovanja ledvic med zdravljenjem z zdravilom Dizoproksiltenofovirat Mylan;
English: hypokalaemia
Slovenian: hipokaliemija
English: Multipack: 90 (3 packs of 30) film-coated tablets
Slovenian: filmsko obložena tableta Skupno pakiranje: 90 (3 škatle po 30) filmsko obloženih tablet
English: Normal ALT ≥ 2 point decrease in CPT from baseline n (%)
Slovenian: ≥ 2 točki nižje število točk po CPT lestvici v primerjavi z izhodiščno vrednostjo n (%)
English: • Do not take Tenofovir disoproxil Mylan if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide.
Slovenian: • Zdravila Dizoproksiltenofovirat Mylan ne jemljite, če že jemljete druga zdravila, ki vsebujejo dizoproksiltenofovirat ali tenofoviralafenamid.