FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbations of hepatitis may lead to hepatic decompensation.
Slovenian: Pri bolnikih z napredovalo boleznijo jeter ali cirozo, prekinitev zdravljenja ni priporočena, saj eksacerbacije hepatitisa po zdravljenju lahko povzročijo jetrno dekompenzacijo.
English: Before starting treatment, your doctor may order blood tests to assess kidney function and may advise you to take a reduced dose of the oral solution or prescribe Emtriva hard capsules.
Slovenian: Pred začetkom zdravljenja bo zdravnik morda naredil krvne preiskave, da bo ocenil delovanje ledvic in vam morda svetoval, da jemljete zmanjšani odmerek peroralne raztopine Emtriva ali predpisal trde kapsule Emtriva.
English: The apparent total body clearance at steady-state (CL/F) increased with age over the 3-month period with a corresponding decrease in AUC.
Slovenian: Opažen skupni telesni očistek pri stanju dinamičnega ravnovesja (CL/F) se je v tem trimesečnem obdobju s starostjo večal, vrednost AUC pa se je ustrezno manjšala.
English: The bottle contains 170 mL of solution.
Slovenian: Plastenka vsebuje 170 ml raztopine.
English: Each capsule has a white opaque body with a light blue opaque cap, of dimensions 19.4 mm x 6.9 mm. Each capsule is printed with “200 mg” on the cap and “GILEAD” and [Gilead logo] on the body in black ink.
Slovenian: Vsaka kapsula ima belo neprosojno telo s svetlo modrim neprosojnim pokrovčkom dimenzije 19,4 mm x 6,9 mm. Na vsaki kapsuli je na pokrovčku odtisnjeno “200 mg” in na telesu “GILEAD” ter [Gilead logo].
English: No data are available on which to make a dose recommendation in paediatric patients with renal insufficiency.
Slovenian: Podatki o priporočenem odmerjanju za pediatrične bolnike z ledvično insuficienco niso na voljo.
English: However, based on the minimal metabolism of emtricitabine and the renal route of elimination it is unlikely that a dose adjustment would be required in patients with hepatic insufficiency (see section 5.2).
Slovenian: Vendar pa je, ob upoštevanju minimalne presnove emtricitabina in izločanja preko ledvic, malo verjetno, da bi bila pri bolnikih z jetrno insuficienco potrebna prilagoditev odmerka (glejte poglavje 5.2).
English: If you are unsure how much Emtriva you should take ask your doctor or pharmacist.
Slovenian: Če ne veste točno, koliko zdravila Emtriva morate vzeti, se posvetujte s svojim zdravnikom ali farmacevtom.
English: In combination studies of emtricitabine with protease inhibitors (PIs), nucleoside, nucleotide and non-nucleoside analogue inhibitors of HIV reverse transcriptase, additive to synergistic effects were observed.
Slovenian: V študijah kombinacije emtricitabina z zaviralci proteaz (PI - protease inhibitors), z nukleozidnimi, nukleotidnimi in ne-nukleozidnimi analogi zaviralcev HIV reverzne transkriptaze so opazili aditivne ali celo sinergistične učinke.
English: Hepatic insufficiency: No data are available on which to make a dose recommendation for patients with hepatic insufficiency.
Slovenian: Jetrna insuficienca: Podatkov o priporočenem odmerjanju za bolnike z jetrno insuficienco ni na voljo.
English: Patients with end-stage renal disease (ESRD) managed with other forms of dialysis such as ambulatory peritoneal dialysis have not been studied and no dose recommendations can be made.
Slovenian: Pri bolnikih z ledvičnim obolenjem v zadnji fazi (ESRD, end-stage renal disease), z drugimi oblikami dialize, kot je npr. ambulantna peritonealna dializa, ni bilo raziskav.
English: Patients with renal insufficiency can also be managed by administration of Emtriva 10 mg/mL oral solution to provide a reduced daily dose of emtricitabine.
Slovenian: Bolniki z ledvično insuficienco so lahko zdravljeni tudi z Emtriva 10 mg/ml peroralno raztopino za zagotovitev zmanjšanega dnevnega odmerka emtricitabina.
English: What Emtriva looks like and contents of the pack
Slovenian: Izgled zdravila Emtriva in vsebina pakiranja
English: If the patient vomits more than 1 hour after taking Emtriva they do not need to take another dose.
Slovenian: Če bolnik bruha več kot 1 uro po jemanju zdravila Emtriva, ne rabi vzeti drugega odmerka.
English: Please also refer to the Summaries of Product Characteristics of the other antiretroviral medicinal products used in the combination regimen.
Slovenian: Prosimo, upoštevajte tudi povzetek glavnih značilnosti drugih protiretrovirusnih zdravil kombiniranih pri zdravljenju.
English: If you accidentally take too many Emtriva hard capsules, contact your doctor or nearest emergency department for advice.
Slovenian: Če ste pomotoma zaužili preveč trdih kapsul Emtriva, se posvetujte z zdravnikom ali poiščite najbližjo urgentno ambulanto.
English: How to take Emtriva • Always take this medicine exactly as your doctor has told you.
Slovenian: Kako jemati zdravilo Emtriva • Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
English: Blood and lymphatic system disorders: Common:
Slovenian: Bolezni krvi in limfatičnega sistema: Pogosti:
English: Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.
Slovenian: Pri bolnikih z jetrnimi boleznimi, vključno s kroničnim hepatitisom B ali C, ki se zdravijo s protiretrovirusnimi zdravili, obstaja povečano tveganje za pojav hudih in potencialno usodnih jetrnih zapletov.
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure, containing 30 hard capsules.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE)s polipropilensko za otroke varno zaporko, ki vsebuje 30 trdih kapsul.
English: hypertriglyceridaemia, hyperglycaemia
Slovenian: hipertrigliceridemija, hiperglikemija
English: The methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).
Slovenian: Metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216) lahko povzročita alergijske reakcije (lahko zapoznele).
English: • The active substance is emtricitabine.
Slovenian: • Zdravilna učinkovina je emtricitabin.
English: In vitro, emtricitabine did not inhibit metabolism mediated by any of the following human CYP450 isoforms: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6 and 3A4.
Slovenian: In vitro emtricitabin ni inhibiral presnovnih reakcij kateregakoli od naslednjih vpletenih izooblik humanih CYP450: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6 in 3A4.
English: Emtriva oral solution contains:
Slovenian: Peroralna raztopina Emtriva vsebuje:
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: Nukleozidni in nukleotidni analogi lahko v različnih stopnjah vplivajo na mitohondrijsko funkcijo, kar je najbolj izrazito pri stavudinu, didanozinu in zidovudinu.
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 predhodno jetrno disfunkcijo, vključno s kroničnim aktivnim hepatitisom, imajo povečano pogostnost motenj jetrne funkcije v času kombiniranega protiretrovirusnega zdravljenja (CART).
English: There are no data regarding the efficacy and only very limited data regarding the safety of emtricitabine in infants below 4 months of age.
Slovenian: Ni podatkov glede učinkovitosti emtricitabina pri dojenčkih, mlajših od 4 mesecev, podatki glede varnosti emtricitabina pa so zelo omejeni.
English: After opening: Do not store above 25°C.
Slovenian: Po odprtju: shranjujte pri temperaturi do 25 °C.
English: Renal insufficiency: Emtricitabine is eliminated by renal excretion and exposure to emtricitabine was significantly increased in patients with renal insufficiency (see section 5.2).
Slovenian: Ledvična insuficienca: Emtricitabin se izloča preko ledvic in izpostavljenost emtricitabinu je pomembno narasla pri bolnikih z ledvično insuficienco (glejte poglavje 5.2).
English: The pharmacokinetics of emtricitabine are proportional to dose over the dose range of 25-200 mg following single or repeated administration.
Slovenian: Farmakokinetične lastnosti emtricitabina po enkratni ali večkratni uporabi so sorazmerne odmerku, in sicer v razponu odmerka med 25 in 200 mg.
English: Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may lead to an increase in serum concentrations of either emtricitabine or a co-administered medicinal product due to competition for this elimination pathway.
Slovenian: Sočasna uporaba emtricitabina z zdravili, ki se izločajo z aktivno tubularno sekrecijo, lahko vodi v povišanje serumskih koncentracij emtricitabina ali sočasno uporabljenih zdravil zaradi kompeticije za to pot izločanja.
English: Psychiatric disorders: Common:
Slovenian: Psihiatrične motnje: Pogosti:
English: Patients with renal insufficiency can also be managed by administration of Emtriva 200 mg hard capsules at modified dose intervals.
Slovenian: Bolniki z ledvično insuficienco so lahko zdravljeni tudi z Emtriva 200 mg trdimi kapsulami ob prilagojenih intervalih odmerjanja.
English: Patients should be instructed that any solution left in the bottle 45 days after opening should be disposed of in accordance with local requirements or returned to the pharmacy.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Bolniki morajo biti opozorjeni, da je treba raztopino zdravila, ki ostane v plastenki po preteku 45 dni od odprtja plastenke, zavreči v skladu z lokalnimi predpisi ali vrniti nazaj v lekarno.
English: What Emtriva is and what it is used for Emtriva is a treatment for Human Immunodeficiency Virus (HIV) infection in adults, children and infants aged 4 months and over.
Slovenian: Kaj je zdravilo Emtriva in za kaj ga uporabljamo Zdravilo Emtriva se uporablja za zdravljenje okužbe z virusom HIV pri odraslih, otrocih in dojenčkih, starih 4 mesece ali več.
English: In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of hepatitis.
Slovenian: Pri bolnikih z napredovalo boleznijo jeter ali cirozo se prekinitev zdravljenja ne priporoča, saj pri nekaterih bolnikih lahko povzroči poslabšanje hepatitisa.
English: Additionally, in a second study, treatment-experienced adults on a stable PI-based highly active antiretroviral therapy (HAART) regimen were randomised to a once daily regimen containing emtricitabine or to continue with their PI-HAART regimen.
Slovenian: V drugi študiji se je pri odraslih, ki se zdravijo dalj časa s PI osnovanim visoko aktivnim stabilnim protiretrovirusnim režimom zdravljenja (HAART, highly active antiretroviral therapy), v nadaljevanju naključno porazdeljeno uporabilo ali kombinirano protiretrovirusno zdravljenje z emtricitabinom ali pa so nadaljevali s PI-HAART režimom.
English: Emtriva is also available as an oral solution for use in children and infants aged 4 months and over, patients who have difficulty in swallowing and patients with kidney problems.
Slovenian: Zdravilo Emtriva je na razpolago tudi v obliki peroralne raztopine, predvsem za uporabo pri otrocih in dojenčkih starih 4 mesece ali več, bolnikih, ki težko požirajo in bolnikih, ki imajo ledvične težave.
English: Emtricitabine in combination with other antiretroviral agents, including nucleoside analogues, non-nucleoside analogues and PIs, has been shown to be effective in the treatment of HIV infection in treatment-naïve patients and treatment-experienced patients with stable virological control.
Slovenian: Emtricitabin, v kombinaciji z drugimi protiretrovirusnimi učinkovinami, vključno z analogi nukleozidov in učinkovinami, ki niso analogi nukleozidov ter PI, se je izkazal za učinkovito zdravilo pri zdravljenju okužbe z virusom HIV pri bolnikih, ki se zdravijo prvič in pri bolnikih, ki se zdravijo že dalj časa in imajo stabilno stanje virusa v telesu.
English: Plasma emtricitabine exposure (AUC) in infants up to 3 months of age who received 3 mg/kg emtricitabine once daily was similar to that observed using 6 mg/kg daily doses in HIV infected adults and children aged 4 months and over.
Slovenian: Plazemska izpostavljenost emtricitabinu (AUC) pri dojenčkih, starih do 3 mesece, ki so prejemali 3 mg/kg emtricitabina enkrat dnevno, je bila podobna tisti, ki so jo opazili pri odraslih in otrocih, starih 4 mesece ali več, okuženih z virusom HIV, ki so prejemali dnevne odmerke 6 mg/kg.
English: Emtricitabine did not inhibit in vitro drug metabolism mediated by the following human CYP450 isoenzymes: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6 and 3A4.
Slovenian: Emtricitabin ni inhibiral in vitro presnove zdravil s pomočjo kateregakoli od naslednjih humanih CYP450 izoencimov: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6 in 3A4.
English: In patients with ESRD on haemodialysis, approximately 30% of the emtricitabine dose was recovered in dialysate over a 3 hour dialysis period which had been started within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and dialysate flow rate of approximately 600 mL/min).
Slovenian: Pri bolnikih z ledvičnim obolenjem v zadnji fazi (ESRD, end-stage renal disease) na hemodializi je bilo približno 30 % odmerka emtricitabina pridobljenega v dializatu po 3 urah dialize, s katero je bolnik začel v roku 1,5 ure po uporabi emtricitabina (pretok krvi je 400 ml/min in pretok dializata je približno 600 ml/min).
English: If a patient misses a dose of Emtriva within 12 hours of the time it is usually taken, the patient should take Emtriva with or without food as soon as possible and resume their normal dosing schedule.
Slovenian: Če bolnik izpusti odmerek zdravila Emtriva v roku 12 ur od časa, ko ga običajno vzame, naj bolnik vzame zdravilo Emtriva s hrano ali brez takoj, ko je mogoče, nato pa nadaljuje s svojim običajnim režimom odmerjanja.
English: When tested for activity against laboratory strains of HBV, the IC50 value for emtricitabine was in the range of 0.01 to 0.04 µmol/l.
Slovenian: Pri testih aktivnosti proti laboratorijskim sevom HBV je bila vrednost IC50 za emtricitabin v razponu od 0,01 do 0,04 µmol/l.
English: If it's less than an hour since you took Emtriva, take another dose.
Slovenian: Če je manj kot ena ura odkar ste vzeli zdravilo Emtriva, vzemite še en odmerek.
English: The pack also contains a 30 mL polypropylene measuring cup with 1.0 mL graduations.
Slovenian: Pakiranje vsebuje še 30 ml polipropilensko merico z 1,0 ml skalo.
English: vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)1,2
Slovenian: vezikulobulozni izpuščaj, pustulozni izpuščaj, makulopapulozni izpuščaj, rdečica, pruritus, koprivnica, sprememba obarvanosti kože (povečana pigmentacija)1,2
English: This medicinal product contains 36 mg of sodium per 24 mL, equivalent to 1.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 36 mg natrija na 24 ml, kar ustreza 1,8 % največjega dnevnega vnosa s hrano, ki ga priporoča Svetovna zdravstvena organizacija (WHO), in znaša 2 g natrija za odraslega.
English: Adults: The recommended dose of Emtriva is one 200 mg hard capsule, taken orally, once daily.
Slovenian: Odrasli: Priporočeni odmerek zdravila Emtriva je ena 200 mg trda kapsula, peroralno, enkrat dnevno.
English: If you notice signs of inflammation or infection soon after you start taking Emtriva,
Slovenian: Če opazite simptome vnetja ali okužbe kmalu po začetku jemanja zdravila Emtriva, o tem nemudoma obvestite zdravnika.
English: Emtricitabine is principally eliminated by the kidney via glomerular filtration and active tubular secretion.
Slovenian: Emtricitabin se v glavnem izloča s pomočjo ledvic preko glomerularne filtracije in aktivne tubularne sekrecije.
English: • The other ingredients are: cotton candy flavouring, disodium edetate, hydrochloric acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sodium phosphate monobasic hydrate, sunset yellow (E110), purified water, xylitol (E967).
Slovenian: • Druge sestavine zdravila so: aroma sladkorne pene (Cotton candy flavouring), dinatrijev edetat, klorovodikova kislina, metilparahidroksibenzoat (E218), propilenglikol, propilparahidroksibenzoat (E216), natrijev hidroksid, natrijev dihidrogenfosfat hidrat, oranžno FCF (E110), prečiščena voda, ksilitol (E967).
English: There was no evidence of toxicity to mitochondria in vitro or in vivo.
Slovenian: Toksičnost za mitohondrije pri in vitro ali in vivo pogojih ni bila dokazana.
English: Emtriva comes in bottles or blister packs containing 30 capsules.
Slovenian: Zdravilo Emtriva je na voljo v plastenkah ali v pretisnih omotih, ki vsebujejo 30 kapsul.
English: While taking Emtriva you may still develop infections or other illnesses associated with HIV infection.
Slovenian: V času uporabe zdravila Emtriva se lahko okužite ali zbolite za boleznimi, ki so povezane z okužbo z virusom HIV.
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Emtriva (see section 4.2).
Slovenian: Verjetnost, da je ledvična funkcija pri starejših bolnikih zmanjšana, je večja, zato je pri zdravljenju starejših bolnikov z zdravilom Emtriva potrebna previdnost (glejte poglavje 4.2).
English: Mechanism of action and pharmacodynamic effects Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to HIV-1, HIV-2 and HBV.
Slovenian: Mehanizem delovanja in farmakodinamski učinki Emtricitabin je sintetični nukleozidni analog citidina z učinkovanjem, ki je specifično HIV-1, HIV-2
English: Paediatric population: The recommended dose of Emtriva 10 mg/mL oral solution is 6 mg/kg up to a maximum of 240 mg (24 mL) once daily.
Slovenian: Pediatrična populacija: Priporočeni odmerek peroralne raztopine Emtriva 10 mg/ml je 6 mg/kg do maksimalno 240 mg (24 ml) enkrat dnevno.
English: Animal studies do not indicate reproductive toxicity.
Slovenian: Študije na živalih ne kažejo na vpliv na sposobnost razmnoževanja.
English: The mean AUC in 77 infants, children and adolescents receiving 6 mg/kg emtricitabine once daily as oral solution or 200 mg emtricitabine as hard capsules once daily was similar to the mean AUC of 10.0 µg·h/mL in 20 adults receiving 200 mg hard capsules once daily.
Slovenian: Povprečna vrednost AUC pri 77 dojenčkih, otrocih in mladostnikih, ki so dobivali 6 mg/kg emtricitabina v obliki peroralne raztopine enkrat dnevno ali 200 mg emtricitabina v obliki trdih kapsul enkrat dnevno je bila podobna povprečni vrednosti AUC 10,0 µg·h/ml pri 20 odraslih, ki so dobivali
English: Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with a reduced dose of emtricitabine (see sections 4.2 and 5.2).
Slovenian: Zato je potrebno pozorno nadzorovati klinični odziv na zdravljenje in ledvično funkcijo pri bolnikih, ki se zdravijo z zmanjšanim odmerkom emtricitabina (glejte poglavji 4.2 in 5.2).
English: In 20 HIV infected subjects receiving 200 mg emtricitabine daily as hard capsules, steady-state plasma emtricitabine peak concentrations (Cmax), trough concentrations (Cmin) and area under the plasma concentration time curve over a 24-hour dosing interval (AUC) were 1.8 ± 0.7 µg/mL, 0.09 ± 0.07 µg/mL and 10.0 ± 3.1 µg·h/mL, respectively.
Slovenian: Pri 20 bolnikih z okužbo z virusom HIV, ki so prejemali 200 mg emtricitabina dnevno v obliki trdih kapsul, so bile koncentracije dinamičnega ravnovesja plazemskega emtricitabina sledeče: najvišja (Cmax) 1,8 ± 0,7 µg/ml, najnižja (Cmin) 0,09 ± 0,07 µg/ml in površina pod časovno krivuljo plazemske koncentracije v 24-urnem dozirnem intervalu (AUC), 10,0 ± 3,1 µg·h/ml.
English: The following side effects are very common (these can affect at least 10 in every 100 patients):
Slovenian: Naslednji neželeni učinki so zelo pogosti (pojavijo se lahko pri najmanj 10 od 100 bolnikov):
English: Recommended dose of Emtriva 10 mg/mL oral solution every 24 hours
Slovenian: Priporočeni odmerek Emtriva 10 mg/ml peroralne raztopine vsakih 24 ur
English: How to store Emtriva
Slovenian: Kako jemati zdravilo Emtriva
English: One 200 mg hard capsule every 96 hours
Slovenian: Ena 200 mg trda kapsula vsakih 96 ur
English: In virologically stable treatment-experienced adults, emtricitabine, in combination with an NRTI (either stavudine or zidovudine) and a PI or an NNRTI was shown to be non-inferior to lamivudine with respect to the proportion of responders (< 400 copies/mL) through 48 weeks (77% emtricitabine, 82% lamivudine).
Slovenian: Pri virološko stabilnih odraslih, ki se zdravijo že dalj časa, se emtricitabin, v kombinaciji z NRTI (ali stavudinom ali zidovudinom) in PI ali NNRTI, ni obnesel slabše od lamivudina glede na delež odzivov (< 400 virionov/ml) v obdobju 48 tednov (77 % emtricitabin, 82 % lamivudin).
English: Adults: The recommended dose of Emtriva 10 mg/mL oral solution is 240 mg (24 mL) once daily.
Slovenian: Odrasli: Priporočeni odmerek Emtriva 10 mg/ml peroralne raztopine je 240 mg (24 ml) enkrat dnevno.
English: • rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
Slovenian: • izpuščaji (vključno z rdečimi pikami ali ogrci, včasih z mehurjasto in oteklo kožo), kar je lahko alergična reakcija, srbečica, sprememba obarvanosti kože, vključujoč temne lise
English: Subjects were grouped according to baseline creatinine clearance (> 80 mL/min as normal function; 50-80 mL/min as mild impairment; 30-49 mL/min as moderate impairment; < 30 mL/min as severe impairment; < 15 mL/min as functionally anephric requiring haemodialysis).
Slovenian: Osebe so bile razdeljene v skupine glede na osnovni očistek kreatinina (> 80 ml/min kot normalna funkcija; 50-80 ml/min kot blaga oslabelost; 30-49 ml/min kot zmerna oslabelost;
English: Children aged 4 months and over, who weigh at least 33 kg may either take one 200 mg hard capsule daily or may take emtricitabine as the oral solution up to a maximum of 240 mg once daily.
Slovenian: Otroci, stari 4 mesece ali več, ki tehtajo vsaj 33 kg lahko vzamejo ali eno 200 mg trdo kapsulo dnevno ali emtricitabin v obliki peroralne raztopine do maksimalno 240 mg enkrat dnevno.
English: Table 1 below provides dose interval adjustment guidelines for the 200 mg hard capsules according to the degree of renal insufficiency.
Slovenian: Spodnja preglednica 1 prikazuje smernice prilagoditve intervala odmerjanja za 200 mg trde kapsule glede na stopnjo ledvične insuficience.
English: You do not need to take another capsule if you were sick more than an hour after taking Emtriva.
Slovenian: Še ene kapsule vam ni treba vzeti, če je bruhanje nastopilo več kot eno uro po zaužitju zdravila Emtriva.
English: There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens (see section 5.1).
Slovenian: Z uporabo zdravila Emtriva pri bolnikih, pri katerih dotedanji ali večkratni režim zdravljenja ni bil uspešen ni izkušenj (glejte poglavje 5.1).
English: Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see section 4.4).
Slovenian: Zaradi tega je potrebno pri teh bolnikih pozorno spremljati klinični odziv na zdravljenje in ledvično funkcijo (glejte poglavje 4.4).
English: One mL of Emtriva oral solution contains 10 mg of emtricitabine (10 mg/mL).
Slovenian: En mililiter peroralne raztopine Emtriva vsebuje 10 mg emtricitabina (10 mg/ml).
English: Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1 to 2 hours post-dose.
Slovenian: Po peroralni uporabi emtricitabina se le-ta hitro in znatno absorbira in doseže najvišjo koncentracijo v plazmi v 1-2 urah.