FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of HIV-1 infection:
Slovenian: Zdravljenje okužbe z virusom HIV-1:
English: Use with ledipasvir and sofosbuvir, sofosbuvir and velpatasvir or sofosbuvir, velpatasvir and voxilaprevir
Slovenian: Uporaba z ledipasvirjem in sofobusvirjem, sofosbuvirjem in velpatasvirjem ali sofosbuvirjem, velpatasvirjem in voksilaprevirjem
English: Cmin: ↑ 51% (↑ 37 to ↑ 66)
Slovenian: Cmin: ↑ 51 % (↑ 37 do ↑ 66)
English: Lopinavir/Ritonavir/Tenofovir disoproxil (400 mg b.i.d./100 mg b.i.d/245 mg q.d.)
Slovenian: lopinavir/ritonavir/dizoproksiltenof ovirat (400 mg b.i.d./100 mg b.i.d./245 mg q.d.)
English: NAME OF THE MEDICINAL PRODUCT Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets
Slovenian: IME ZDRAVILA Emtricitabin/dizoproksiltenofovirat Mylan 200 mg/245 mg filmsko obložene tablete
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil (see section 4.8).
Slovenian: Pri klinični uporabi dizoproksiltenofovirata so poročali o ledvični odpovedi, ledvični okvari, zvišanem kreatininu, hipofosfatemiji in proksimalni tubulopatiji (vključno s Fanconijevim sindromom) (glejte poglavje 4.8).
English: Bottle pack: Once opened use within 90 days.
Slovenian: Pakiranje s plastenko: Po prvem odprtju porabite v 90 dneh.
English: Table 8: Study population from study CO-US-104-0380 (Partners PrEP)
Slovenian: Preglednica 8: Populacija v študiji CO-US-104-0380 (Partners PrEP)
English: Relative Risk Reduction (95% CI)
Slovenian: Relativno zmanjšanje tveganja (95-% IZ)
English: anaemia2
Slovenian: anemija2
English: Physicians should refer to current HIV treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).
Slovenian: Za zdravljenje okužbe z virusom HIV pri bolnikih, ki so hkrati okuženi z virusom hepatitisa B (HBV) ali virusom hepatitisa C (HCV), naj zdravniki upoštevajo trenutno veljavne smernice za zdravljenje HIV.
English: (may affect up to 1 in 100 people)
Slovenian: (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: Mean changes at week 48 (end of double-blind phase) were -0.215 and -0.165 in lumbar spine BMD Z-score, and -0.254 and -0.179 in total body BMD Z-score for the tenofovir disoproxil and placebo groups, respectively.
Slovenian: Povprečni spremembi v 48. tednu (konec dvojno slepe faze) sta bili −0,215 oz. −0,165 za Z-vrednost MGK ledvene hrbtenice in −0,254 oz. −0,179 za Z-vrednost MGK za celo telo za skupino z dizoproksiltenofoviratom in skupino s placebom.
English: AUC: ↑ 40% (↑ 31 to ↑ 50) Cmax: ↔
Slovenian: AUC: ↑ 40 % (↑ 31 do ↑ 50) Cmax: ↔
English: AUC: ↓ 29% (↓ 36 to ↓ 22) Cmax: ↓ 41% (↓ 51 to ↓ 29)
Slovenian: AUC: ↓ 29 % (↓ 36 do ↓ 22) Cmax: ↓ 41 % (↓ 51 do ↓ 29)
English: Alternative treatment regimens should be considered for patients with osteoporosis that are at a high risk for fractures.
Slovenian: Pri bolnikih z osteoporozo, pri katerih je tveganje za zlome veliko, je treba razmisliti o alternativnih režimih zdravljenja.
English: The recommended dose of Emtricitabine/Tenofovir disoproxil Mylan to treat HIV is:
Slovenian: Priporočeni odmerek zdravila Emtricitabin/dizoproksiltenofovirat Mylan za zdravljenje okužbe s HIV je:
English: At 48 weeks, 70% and 64% of patients demonstrated HIV-1 RNA < 50 copies/mL with the once and twice daily regimens of lopinavir/ritonavir, respectively.
Slovenian: V 48. tednu je 70 % bolnikov v režimu zdravljenja z lopinavirjem/ritonavirjem enkrat na dan in 64% bolnikov v režimu zdravljenja z lopinavirjem/ritonavirjem dvakrat na dan izkazalo HIV-1 RNA < 50 kopij/ml.
English: • Provides information on how to store Emtricitabine/Tenofovir Mylan.
Slovenian: • nudi informacije o tem, kako jemati zdravilo Emtricitabin/dizoproksiltenofovirat Mylan;
English: What Emtricitabine/Tenofovir disoproxil Mylan is and what it is used for
Slovenian: Kaj je zdravilo Emtricitabin/dizoproksiltenofovirat Mylan in za kaj ga uporabljamo
English: What you need to know before you take Emtricitabine/Tenofovir disoproxil Mylan
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Emtricitabin/dizoproksiltenofovirat Mylan
English: In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Z score was -1.004 and -0.809, and mean total body BMD Z-score was -0.866 and -0.584, respectively, at baseline.
Slovenian: Pri bolnikih, ki so dobivali dizoproksiltenofovirat ali placebo, je bila ob izhodišču povprečna Z-vrednost MGK ledvene hrbtenice −1,004 oz. −0,809, in povprečna Z-vrednost MGK za celo telo −0,866 oz.
English: Emtricitabine and tenofovir are phosphorylated by cellular enzymes to form emtricitabine triphosphate and tenofovir diphosphate, respectively.
Slovenian: Celični encimi fosforilirajo emtricitabin v emtricitabin trifosfat in tenofovir v tenofovir difosfat.
English: HIV/HBV or HCV co-infected patients: The adverse reaction profile of emtricitabine and tenofovir disoproxil in a limited number of HIV-infected patients in study GS-01-934 who were co-infected with HBV (n = 13) or HCV (n = 26) was similar to that observed in patients infected with HIV without co-infection.
Slovenian: Bolniki s hkratno okužbo HIV/HBV ali HCV: Neželeni učinki emtricitabina in dizoproksiltenofovirata v študiji GS-01-934 pri omejenem številu bolnikov s HIV, ki so bili hkrati okuženi še s HBV (n = 13) ali
English: Recommendation concerning co-administration with emtricitabine/tenofovir disoproxil (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Slovenian: Priporočilo glede sočasne uporabe z emtricitabinom/dizoproksiltenofovirato m (emtricitabin 200 mg, dizoproksiltenofovirat 245 mg)
English: Cmin: ↑ 63% (↑ 45 to ↑ 84)
Slovenian: Cmin: ↑ 63 % (↑ 45 do ↑ 84)
English: AUC: ↓ 28% (↓ 34 to ↓ 20) Cmax: ↓ 38% (↓ 46 to ↓ 29)
Slovenian: AUC: ↓ 28 % (↓ 34 do ↓ 20) Cmax: ↓ 38 % (↓ 46 do ↓ 29)
English: Table 10: Efficacy and adherence in study CO-US-104-0380 (Partners PrEP)
Slovenian: Preglednica 10: Učinkovitost in adherenca v študiji CO-US-104-0380 (Partners PrEP)
English: AUC: ↓ 27% (↓ 35 to ↓ 18) Cmax: ↓ 37% (↓ 48 to ↓ 25)
Slovenian: AUC: ↓ 27 % (↓ 35 do ↓ 18) Cmax: ↓ 37 % (↓ 48 do ↓ 25)
English: WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Slovenian: ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
English: The mean (%CV) tenofovir drug exposure increased from 2,185 (12%) ng•h/mL in subjects with normal renal function, to 3,064 (30%) ng•h/mL, 6,009 (42%) ng•h/mL and 15,985 (45%) ng•h/mL, in subjects with mild, moderate and severe renal impairment, respectively.
Slovenian: Pri osebah z normalno ledvično funkcijo s srednjo vrednostjo (% koeficienta variacije) izpostavljenosti tenofovirju 2.185 (12 %) ng•h/ml se je le-ta pri osebah z blago ledvično okvaro zvišala na 3.064 (30 %) ng•h/ml, pri osebah z zmerno ledvično okvaro na 6.009 (42 %) ng•h/ml in na 15.985 (45 %) ng•h/ml pri osebah s hudo ledvično okvaro.
English: Cmax: ↑ 38% (↑ 14 to ↑ 67)
Slovenian: Cmax: ↑ 38 % (↑ 14 do ↑ 67)
English: Tenofovir disoproxil 245 mg)+Emtricitabine/tenofovir disoproxil
Slovenian: Dizoproksiltenofovirat 245 mg + emtricitabin/dizoproksiltenofovirat
English: HIV-1 infected patients receiving emtricitabine/tenofovir disoproxil or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Slovenian: Pri bolnikih s HIV-1, ki se zdravijo z emtricitabinom/dizoproksiltenofoviratom ali s katero koli drugo obliko protiretrovirusne terapije, lahko še vedno pride do oportunistične okužbe in drugih zapletov okužbe z virusom HIV.
English: Cmax: ↑ 25% (↑ 8 to ↑ 45) Cmin: ↔
Slovenian: Cmax: ↑ 25 % (↑ 8 do ↑ 45) Cmin: ↔
English: Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (see section 4.4).
Slovenian: ganciklovir, pentamidin, vankomicin, cidofovir ali interlevkin-2, vendar pa niso omejeni nanje (glejte poglavje 4.4).
English: • ganciclovir (for viral infection)
Slovenian: • ganciklovir (za virusno okužbo)
English: Cmin: ↑ 45% (↑ 27 to ↑ 64)
Slovenian: Cmin: ↑ 45 % (↑ 27 do ↑ 64)
English: Medicinal product by therapeutic areas
Slovenian: Učinkovine po terapevtskih področjih
English: Cmin: ↑ 29% (↑ 15 to ↑ 44)
Slovenian: Cmin: ↑ 29 % (↑ 15 do ↑ 44)
English: • amphotericin B (for fungal infection)
Slovenian: • amfotericin B (za glivno okužbo)
English: The steady-state pharmacokinetics of emtricitabine and tenofovir were unaffected when emtricitabine and tenofovir disoproxil were administered together versus each medicinal product dosed alone.
Slovenian: Farmakokinetične lastnosti emtricitabina in tenofovirja se v stanju dinamičnega ravnovesja niso spremenile, če sta bila emtricitabin in dizoproksiltenofovirat vzeta sočasno ali vsak posamezno.
English: If serum phosphate is confirmed to be < 3.0 mg/dL (0.96 mmol/L) in any paediatric patient receiving Emtricitabine/tenofovir disoproxil, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Slovenian: Če je potrjena vrednost serumskega fosfata < 3,0 mg/dl (0,96 mmol/l) pri katerem koli pediatričnem bolniku, ki dobiva emtricitabin/dizoproksiltenofovirat, je treba ponovno ovrednotiti ledvično funkcijo v roku enega tedna, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4.8, proksimalna tubulopatija).
English: Cmax: ↑ 47% (↑ 37 to ↑ 58) Cmin: ↑ 47% (↑ 38 to ↑ 57)
Slovenian: Cmax: ↑ 47 % (↑ 37 do ↑ 58) Cmin: ↑ 47 % (↑ 38 do ↑ 57)
English: No dose adjustment of ribavirin is required.
Slovenian: Prilagoditev odmerka ribavirina ni potrebna.
English: The effectiveness of Emtricitabine/tenofovir disoproxil in reducing the risk of acquiring HIV-1 is strongly correlated with adherence as demonstrated by measurable drug levels in blood (see section 5.1).
Slovenian: Učinkovitost emtricitabina/dizoproksiltenofovirata za zmanjšanje tveganja za okužbo s HIV-1 je v veliki meri odvisna od adherence, ki jo lahko preverimo z merjenjem koncentracije učinkovin v krvi
English: Metabolism and nutrition disorders:
Slovenian: Presnovne in prehranske motnje:
English: The mean (%CV) emtricitabine drug exposure increased from 12 (25%) μg•h/mL in subjects with normal renal function, to 20 (6%) μg•h/mL, 25 (23%) μg•h/mL and 34 (6%) μg•h/mL, in subjects with mild, moderate and severe renal impairment, respectively.
Slovenian: Pri osebah z normalno ledvično funkcijo s srednjo vrednostjo (% koeficienta variacije) izpostavljenosti emtricitabinu 12 (25 %) µg•h/ml se je le-ta pri osebahz blago ledvično okvaro zvišala na 20 (6 %) µg•h/ml, pri osebah z zmerno ledvično okvaro na 25 (23 %) µg•h/ml in in pri osebah s hudo ledvično okvaro na 34 (6 %) µg•h/ml.
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10)
Slovenian: AUC: ↓ 25 % (↓ 42 do ↓ 3) Cmax: ↓ 28 % (↓ 50 do ↑ 5) Cmin: ↓ 26 % (↓ 46 do ↑ 10)
English: • decreases in potassium in the blood
Slovenian: • zmanjšanje količine kalija v krvi
English: The combination should be used with caution with frequent renal monitoring (see section 4.4).
Slovenian: To kombinacijo je treba uporabljati pazljivo s pogostim spremljanjem delovanja ledvic (glejte poglavje 4.4).
English: Lamivudine and emtricitabine/tenofovir disoproxil should not be administered concomitantly (see section 4.4).
Slovenian: Lamivudina in emtricitabina/dizoproksiltenofovirata se ne sme uporabljati sočasno (glejte poglavje 4.4).
English: AUC: ↑ 32% (↑ 25 to ↑ 38) Cmax: ↔
Slovenian: AUC: ↑ 32 % (↑ 25 do ↑ 38) Cmax: ↔
English: • aminoglycosides (for bacterial infection)
Slovenian: • aminoglikozidi (za bakterijsko okužbo)
English: Cmax: ↑ 55% (↑ 43 to ↑ 68) Cmin: ↑ 39% (↑ 31 to ↑ 48)
Slovenian: Cmax: ↑ 55 % (↑ 43 do ↑ 68) Cmin: ↑ 39 % (↑ 31 do ↑ 48)
English: If vomiting occurs within 1 hour of taking Emtricitabine/Tenofovir disoproxil Mylan, another tablet should be taken.
Slovenian: Če v roku 1 ure od jemanja zdravila Emtricitabin/dizoproksiltenofovirat Mylan pride do bruhanja, je potrebno vzeti drugo tableto.
English: How to take Emtricitabine/Tenofovir disoproxil Mylan 4.
Slovenian: Kako jemati zdravilo Emtricitabin/dizoproksiltenofovirat Mylan 4.
English: Didanosine: The co-administration of emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 2).
Slovenian: Didanozin: Sočasna uporaba emtricitabina/dizoproksiltenofovirata in didanozina ni priporočljiva (glejte poglavje 4.4 in preglednico 2).
English: lactic acidosis
Slovenian: OPIOIDNI ANALGETIKI
English: This medicine is available in plastic bottles containing a desiccant (DO NOT EAT THE DESICCANT) containing 30 film-coated tablets and in multipacks of 90 film-coated tablets comprising 3 bottles, each containing 30 film-coated tablets or blister packs containing embedded desiccant containing 30, 30x1, 90x1 or 100x1 film-coated tablets
Slovenian: Zdravilo je na voljo v plastenkah s sušilnim sredstvom (SUŠILNEGA SREDSTVA NE SMETE ZAUŽITI) s po 30 filmsko obloženimi tabletami in v večkratnih pakiranjih z 90 filmsko obloženimi tabletami, sestavljenih iz 3 plastenk, vsaka s po 30 filmsko obloženimi tabletami.
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24)
Slovenian: AUC: ↓ 34 % (↓ 41 do ↓ 25) Cmax: ↓ 34 % (↓ 41 do ↑ 25) Cmin: ↓ 34 % (↓ 43 do ↑ 24)
English: once daily.
Slovenian: in enkrat na dan pa s ''q.d.'').
English: • That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving tenofovir disoproxil, renal function should be re-evaluated within one week.
Slovenian: • da je treba po enem tednu delovanje ledvic ponovno oceniti, če so potrjene vrednosti serumskega fosfata < 3,0 mg/dl (0,96 mmol/l) pri vsakem pediatričnem bolniku, ki dobiva dizoproksiltenofovirat.
English: HIV-1 RNA < 400 copies/mL (TLOVR) p-value % difference (95%CI)
Slovenian: HIV-1 RNA < 400 kopij/ml (TLOVR)
English: Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets emtricitabine/tenofovir disoproxil
Slovenian: Emtricitabin/dizoproksiltenofovirat Mylan 200 mg/245 mg filmsko obložene tablete emtricitabin/dizoproksiltenofovirat
English: • Do not breast-feed during treatment with Emtricitabine/Tenofovir disoproxil Mylan.
Slovenian: • Med zdravljenjem z zdravilom Emtricitabin/dizoproksiltenofovirat Mylan ne dojite.
English: AUC: ↑ 81% (↑ 68 to ↑ 94) Cmax: ↑ 77% (↑ 53 to ↑ 104) Cmin: ↑ 121% (↑ 100 to
Slovenian: AUC: ↑ 81 % (↑ 68 do ↑ 94) Cmax: ↑ 77 % (↑ 53 do ↑ 104) Cmin: ↑ 121 % (↑ 100 do
English: Tell your doctor if you have had kidney disease, or if tests have shown kidney problems.
Slovenian: Če ste kdaj prej imeli bolezni ledvic ali če so preiskave kazale na ledvične težave, o tem obvestite zdravnika.
English: No dose adjustment of famciclovir is required.
Slovenian: Prilagoditev odmerka famciklovirja ni potrebna.
English: Antiretrovirals
Slovenian: PERORALNI KONTRACEPTIVI
English: • diarrhoea, being sick (vomiting), feeling sick (nausea)
Slovenian: • driska, bruhanje, občutek siljenja na bruhanje (navzea)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Slovenian: ZUNANJA ŠKATLA VEČKRATNEGA PAKIRANJA (Z MODRIM OKENCEM) 1.
English: • You must be HIV negative before you start to take this medicine to reduce the risk of getting HIV.
Slovenian: • Pred začetkom jemanja tega zdravila za zmanjšanje tveganja za okužbo z virusom HIV-1 morate biti HIV-negativni.
English: Table 9: Efficacy in study CO-US-104-0380 (Partners PrEP)
Slovenian: Preglednica 9: Učinkovitost v študiji CO-US-104-0380 (Partners PrEP)
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 60 mL/min in any individual receiving emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Slovenian: Če je vrednost serumskega fosfata < 1,5 mg/dl (0,48 mmol/l) ali se očistek kreatinina zmanjša na < 60 ml/min, je pri vsakem posamezniku, ki prejema emtricitabin/dizoproksiltenofovirat za zaščito pred izpostavitvijo, treba ponovno ovrednotiti ledvično funkcijo v roku enega tedna, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4.8, proksimalna tubulopatija).
English: AUC: ↑ 65% (↑ 59 to ↑ 71) Cmax: ↑ 61% (↑ 51 to ↑ 72) Cmin: ↑ 115% (↑ 105 to
Slovenian: AUC: ↑ 65 % (↑ 59 do ↑ 71) Cmax: ↑ 61 % (↑ 51 do ↑ 72) Cmin: ↑ 115 % (↑ 105 do
English: Emtricitabine/Tenofovir disoproxil Mylan contains lactose
Slovenian: Zdravilo Emtricitabin/dizoproksiltenofovirat Mylan vsebuje laktozo
English: headache dizziness
Slovenian: Jetrna okvara
English: Study Drug Quantification
Slovenian: Količinska opredelitev preiskovanega zdravila
English: No dose adjustment of efavirenz is required.
Slovenian: Prilagoditev odmerka efavirenza ni potrebna.
English: The pharmacokinetics of emtricitabine/tenofovir disoproxil have not been studied in subjects with hepatic impairment.
Slovenian: Farmakokinetike emtricitabina/dizoproksiltenofovirata niso proučevali pri osebah z jetrno okvaro.
English: The rate of HIV-1 seroconversion in males was 0.24/100 person-years of emtricitabine/tenofovir disoproxil exposure and the rate of HIV-1 seroconversion in females was 0.95/100 person-years of emtricitabine/tenofovir disoproxil exposure.
Slovenian: Stopnja serokonverzije HIV-1 pri moških, ki so prejemali emtricitabin/dizoproksiltenofovirat, je bila 0,24/100 človek-let, stopnja serokonverzije HIV-1 pri ženskah, ki so prejemale emtricitabin/dizoproksiltenofovirat, pa je bila 0,95/100 človek-let Učinkovitost je bila močno odvisna od adherence, kar je bilo ocenjeno z zaznavanjem koncentracij učinkovine v plazmi ali znotraj celic, in je bila višja pri sodelujočih v podštudiji, ki so bili deležni aktivnega svetovanja glede adherence, kot je prikazano v preglednici 10.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 200 mg emtricitabina in 245 mg dizoproksiltenofovirata (kar ustreza300 mg dizoproksiltenofovirijevega maleata).
English: • foscarnet (for viral infection)
Slovenian: • foskarnet (za virusno okužbo)
English: Treatment of HIV-1 infection
Slovenian: Zdravljenje okužbe s HIV-1
English: AUC: ↓ 4% (↓ 9 to ↑ 0) Cmax: ↓ 6% (↓ 13 to ↑ 0) Cmin: ↓ 2% (↓ 9 to ↑ 6)
Slovenian: AUC: ↓ 4 % (↓ 9 do ↑ 0) Cmax: ↓ 6 % (↓ 13 do ↑ 0) Cmin: ↓ 2 % (↓ 9 do ↑ 6)
English: Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV 1 infected paediatric patients aged 2 to < 12 years in clinical study GS US 104 0352 (see sections 4.8 and 5.1).
Slovenian: Pri pediatričnih bolnikih, starih od 2 do < 12 let, okuženih s HIV-1, so v klinični študiji GS-US-1040352 poročali o neželenih učinkih na ledvice, skladnih s proksimalno renalno tubulopatijo (glejte poglavji 4.8 in 5.1).
English: Emtricitabine/tenofovir disoproxil has not been studied in patients over 65 years of age.
Slovenian: Emtricitabin/dizoproksiltenofovirat Mylan niso proučevali pri bolnikih, starejših od 65 let.
English: • Talk to your doctor if you have a history of liver disease, including hepatitis.
Slovenian: • Če ste imeli ali imate jetrne bolezni, vključno s hepatitisom, se posvetujte z zdravnikom.
English: Cmin: ↑ 48% (↑ 34 to ↑ 63)
Slovenian: Cmin: ↑ 48 % (↑ 34 do ↑ 63)
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 50 mL/min in any patient receiving, emtricitabine/tenofovir disoproxil renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Slovenian: Če je vrednost serumskega fosfata < 1,5 mg/dl (0,48 mmol/l) ali se očistek kreatinina zmanjša na < 50 ml/min, je pri vsakem bolniku, ki prejema emtricitabin/dizoproksiltenofovirat, treba ponovno ovrednotiti ledvično funkcijo v roku enega tedna, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4.8, proksimalna tubulopatija).
English: AUC: ↑ 6% (↓ 1 to ↑ 13) Cmax: ↑13% (↑ 1 to ↑ 27) Cmin: NC
Slovenian: AUC: ↑ 6 % (↓ 1 do ↑ 13) Cmax: ↑ 13 % (↑ 1 do ↑ 27) Cmin: n/i
English: Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor.
Slovenian: tenofovir pa nukleotidni zaviralec reverzne transkriptaze.
English: If emtricitabine/tenofovir disoproxil is co-administered with an NSAID, renal function should be monitored adequately.
Slovenian: Pri sočasnem jemanju emtricitabina/dizoproksiltenofovirata z NSAID je potrebno spremljati ledvično funkcijo.
English: Do not stop taking Emtricitabine/Tenofovir disoproxil Mylan
Slovenian: Ne prenehajte z zdravljenjem z zdravilom Emtricitabin/dizoproksiltenofovirat Mylan
English: • That if bone abnormalities are detected or suspected then consultation with an endocrinologist and/or nephrologist should be obtained
Slovenian: • da se je treba ob odkritju kostnih nenormalnosti ali sumu nanje posvetovati z endokrinologom in/ali nefrologom.
English: Consideration should be given to interrupting use of with emtricitabine/tenofovir disoproxil in individuals with creatinine clearance decreased to < 60 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Slovenian: Pri posameznikih z zmanjšanjem očistka kreatinina na < 60 ml/min ali z zmanjšanjem serumskega fosfata na < 1,0 mg/dl (0,32 mmol/l) je treba razmisliti o prekinitvi uporabe emtricitabina/dizoproksiltenofovirata.
English: The use of emtricitabine/tenofovir disoproxil is not recommended in individuals under the age of 18 years with renal impairment (see section 4.2).
Slovenian: Uporabe emtricitabina/dizoproksiltenofovirata pri posameznikih z ledvično okvaro, starih manj kot 18 let, se ne priporoča (glejte poglavje 4.2).
English: Ask your doctor if you have any more questions about how to prevent getting HIV or spreading HIV to other people.
Slovenian: Če imate kakršna koli dodatna vprašanja o preprečevanju okužbe s HIV ali prenašanju HIV na druge ljudi, se posvetujte z zdravnikom.
English: If you have HBV, there is a serious risk of liver problems when you stop taking emtricitabine/tenofovir disoproxil, whether or not you also have HIV.
Slovenian: Če imate hepatitis B, obstaja resno tveganje za jetrne težave, ko prenehate jemati emtricitabin/dizoproksiltenofovirat, ne glede na to, ali imate HIV ali ne. Pomembno je, da emtricitabina/dizoproksiltenofovirata ne prenehate jemati, ne da bi se posvetovali s svojim zdravnikom: glejte poglavje 3 Ne prenehajte jemati zdravila
English: Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate).
Slovenian: Ena filmsko obložena tableta vsebuje 200 mg emtricitabina in 245 mg dizoproksiltenofovirata (kar ustreza 300 mg dizoproksiltenofovirijevega maleata).
English: The safety of tenofovir disoproxil when co-administered with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
Slovenian: Varnost dizoproksiltenofovirata skupaj z ledipasvirjem/sofosbuvirjem, sofosbuvirjem/velpatasvirjem ali sofosbuvirjem/velpatasvirjem/voksilaprevirjem in farmakokinetičnim ojačevalcem ni bila ugotovljena.