natgillin/translations-raw huggingface dataset:
Such exacerbations have been seen following discontinuation of emtricitabine treatment in HBV infected patients without concomitant HIV infection and have been detected primarily by serum alanine aminotransferase (ALT) elevations in addition to re-emergence of HBV DNA.
Takšno poslabšanje je bilo opaženo po prekinitvi zdravljenja z emtricitabinom pri bolnikih z okužbo s HBV brez hkratne okužbe z virusom HIV in je bilo primarno odkrito s povišanjem serumskega nivoja alanin-aminotransferaze (ALT) z dodatnim ponovnim pojavom HBV DNA.
Steady-state trough plasma concentrations reached levels approximately 4-fold above the in vitro IC90 values for anti-HIV activity.
Doseženo najnižje stanje dinamičnega ravnovesja plazemskih koncentracij (steady-state trough plasma concentrations) je bilo približno 4-krat nad in vitro IC90 vrednostmi za anti-HIV aktivnost.
• being sick (vomiting), problems with digestion resulting in discomfort after meals, stomach pain
• bruhanje, prebavne motnje, ki privedejo do slabega počutja po zaužitem obroku, bolečina v trebuhu
Other possible effects
Drugi možni učinki
The use of emtricitabine in patients with chronic HBV induces the same mutation pattern in the YMDD motif observed with lamivudine therapy.
Uporaba emtricitabina pri bolnikih s kronično okužbo z virusom HBV povzroča enak vzorec mutacij v motivu YMDD, kot je opažen pri terapiji z lamivudinom.
• Adults: Your doctor will advise the correct amount of Emtriva oral solution to be taken.
• Odrasli: Vaš zdravnik vam bo predpisal ustrezno količino peroralne raztopine Emtriva, ki jo morate jemati.
Sunset yellow (E110) may cause allergic reactions.
Oranžno FCF (E110) lahko povzroči alergijske reakcije.
Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Po peroralni uporabi zdravila je razpolovna doba emtricitabina približno 10 ur.
• Infants, children and adolescents weighing 40 kg or less: the dose of Emtriva 10 mg/mL oral solution is calculated according to your body weight.
• Dojenčki, otroki in mladostniki s telesno maso nižjo od 40 kg: odmerek peroralne raztopine Emtriva 10 mg/ml je izračunan na osnovi vaše telesne mase.
Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Emtriva.
Krvne preiskave ali simptomi pri nekaterih bolnikih so kazali, da se je njihov hepatitis poslabšal po prenehanju zdravljenja z zdravilom Emtriva.
3 This adverse reaction, which was identified through post-marketing surveillance, was not observed in randomised controlled clinical trials in adults or paediatric HIV clinical trials of emtricitabine.
3 To neželeno reakcijo, ki je bila opredeljena v okviru nadzora v obdobju trženja zdravila, niso opazili v randomiziranih kontroliranih kliničnih študijah pri odraslih ali pediatričnih bolnikih, okuženih z virusom HIV.
In general, emtricitabine pharmacokinetics in HBV infected subjects were similar to those in healthy subjects and in HIV infected subjects.
Na splošno je bila farmakokinetika emtricitabina pri osebah, okuženih z virusom HBV, zelo podobna tisti pri zdravih osebah in osebah, okuženih z virusom HIV.
In antiretroviral treatment-naïve adults, emtricitabine was significantly superior to stavudine when both medicinal products were taken in combination with didanosine and efavirenz through 48 weeks of treatment.
Pri odraslih, ki se s protiretrovirusnim zdravilom zdravijo prvič, je bil emtricitabin opazno močnejši od stavudina, ko sta bili obe zdravili uporabljeni v kombinaciji z didanozinom in efavirenzom v času 48-tedenskega zdravljenja.
In clinical trials of HIV infected adults, the most frequently occurring adverse reactions to emtricitabine were diarrhoea (14.0%), headache (10.2%), elevated creatine kinase (10.2%) and nausea (10.0%).
V kliničnih študijah odraslih bolnikov, okuženih z virusom HIV, so bile najpogostejše neželene reakcije na emtricitabin driska (14,0 %), glavobol (10,2 %), povišanje kreatin-kinaze (10,2 %) in navzea (10,0 %).
If there is any solution left in the bottle after 45 days, this should be disposed of in accordance with local requirements or returned to the pharmacy.
Če vam je po 45 dneh ostalo še kaj raztopine v plastenki, morate to raztopino zavreči v skladu z lokalnimi predpisi ali vrniti nazaj v lekarno.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Znaki osteonekroze so togost sklepa, bolečine v sklepu (zlasti v kolku, kolenu in rami) in težave z gibljivostjo.
There are no clinically significant interactions when emtricitabine is co-administered with indinavir, zidovudine, stavudine, famciclovir or tenofovir disoproxil fumarate.
Ni klinično pomembnih interakcij, ko se emtricitabin uporablja skupaj z: indinavirom, zidovudinom, stavudinom, famciklovirom ali dizoproksiltenofoviratom fumaratom.
The apparent volume of distribution after intravenous administration of emtricitabine was 1.4 ± 0.3 L/kg, indicating that emtricitabine is widely distributed throughout the body to both intracellular and extracellular fluid spaces.
Po intravenozni uporabi emtricitabina je bil opažen volumen porazdelitve 1,4 ± 0,3 l/kg, kar nakazuje, da je emtricitabin v telesu široko distribuiran tako znotraj kot zunaj celičnega prostora.
Examples of body weight and the corresponding doses and volumes of the oral solution to be taken each day are given in the table below:
Primeri telesne mase in pripadajočih odmerkov ter volumnov peroralne raztopine, ki jih je treba jemati dnevno, so navedeni v spodnji preglednici.
• If you have problems with your kidneys, your doctor may advise you to take Emtriva less frequently.
• Če imate ledvične težave, vam bo zdravnik morda svetoval, da jemljete zdravilo Emtriva manj pogosto.
Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites.
13 % odmerka emtricitabina je iz urina izoliranega v obliki treh metabolitov.
Consequently, the use of emtricitabine in combination with lamivudine for the treatment of HIV infection cannot be recommended at this time.
Zaradi tega uporaba emtricitabina v kombinaciji z lamivudinom za zdravljenje okužbe z virusom HIV za sedaj še ni priporočljiva.
If you do miss a dose of Emtriva within 12 hours of when it is usually taken, take it as soon as you can, and then take your next dose at its regular time.
Če ste pozabili vzeti odmerek zdravila Emtriva v roku 12 ur od časa, ko ga običajno vzamete, ga vzemite čim prej in nato vzemite naslednji odmerek ob običajnem času.
In the adult studies, 1,039 treatment-naïve and 440 treatment-experienced patients received emtricitabine (n = 814) or comparator medicinal product (n = 665) for 48 weeks in combination with other antiretroviral medicinal products.
V študijah z odraslimi bolniki je 1.039 bolnikov, ki se zdravijo prvič, in 440 bolnikov, ki se zdravijo že dalj časa, prejemalo emtricitabin (n = 814) ali primerljivo zdravilo (n = 665) 48 tednov v kombinaciji z drugimi protiretrovirusnimi zdravili.
Patients co-infected with HIV and HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with emtricitabine for evidence of exacerbations of hepatitis.
Bolnike s hkratno HIV in HBV okužbo je potrebno pozorneje opazovati in opraviti potrebne klinične in laboratorijske teste še vsaj nekaj mesecev po prenehanju zdravljenja z emtricitabinom zaradi možnosti poslabšanja hepatitisa.
No human data on the effect of emtricitabine are available.
Ni podatkov o učinkih emtricitabina za ljudi.
The mean plasma to blood concentration ratio was approximately 1.0 and the mean semen to plasma concentration ratio was approximately 4.0.
Povprečna vrednost razmerja med plazemsko koncentracijo in koncentracijo v krvi je bila približno 1,0 in povprečna vrednost razmerja med koncentracijo v semenski tekočini in koncentracijo v plazmi je bila približno 4,0.
• Children and adolescents up to 18 years of age who weigh at least 33 kg and who are able to swallow hard capsules: one 200 mg hard capsule, each day with or without food.
• Za otroke in mladino do 18. leta starosti, ki tehtajo najmanj 33 kg, in ki lahko pogoltnejo trdo kapsulo: ena 200 mg trda kapsula dnevno z ali brez hrane.
Contains E110, E216, E218, sodium and propylene glycol, see leaflet for further information.
SEZNAM POMOŽNIH SNOVI Vsebuje E110, E216, E218, natrij in propilenglikol, za nadaljnje informacije glejte navodilo za uporabo.
These are only suitable for patients who weigh at least 33 kg and can swallow hard capsules.
Te so primerne samo za bolnike, ki tehtajo najmanj 33 kg in ki lahko pogoltnejo trdo kapsulo.
This active substance is an antiretroviral medicine which is used to treat HIV infection.
Ta zdravilna učinkovina je protiretrovirusno zdravilo, ki se uporablja za zdravljenje okužbe z virusom HIV.
Intracellular triphosphate levels increased with dose, but reached a plateau at doses of 200 mg or greater.
Nivo znotrajceličnega trifosfata s količino zdravila narašča, vendar doseže svoj plato pri odmerku 200 mg ali več.
2 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients (see section 4.8, Paediatric population).
2 Anemija je bila pogosta in sprememba obarvanosti kože (povečana pigmentacija) je bila zelo pogosta pri uporabi emtricitabina pri pediatričnih bolnikih (glejte poglavje 4.8, Pediatrična populacija).
Speak with your doctor before you stop, particularly if you are experiencing any side effects or you have another illness.
Preden prenehate z zdravljenjem, se pogovorite z zdravnikom, še zlasti če imate kakršnekoli neželene učinke ali kakšno drugo bolezen.
Warnings and precautions • Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys.
• Obvestite svojega zdravnika, če ste kdaj prej imeli bolezni ledvic ali če so preiskave kazale na težave z ledvicami.
Your doctor may also order blood tests during treatment to monitor your kidneys.
Vaš zdravnik bo morda naredil krvne preiskave v času zdravljenja, da bo nadzoroval stanje vaših ledvic.
For infants from 4 months, children, and patients who are unable to swallow hard capsules and patients with kidney problems, Emtriva is available as a liquid (an oral solution).
Za dojenčke, stare najmanj 4 mesece, otroke in bolnike, ki ne morejo pogoltniti trde kapsule, in za bolnike z ledvičnimi težavami je zdravilo Emtriva na voljo tudi kot tekočina (peroralna raztopina).
Emtriva 200 mg hard capsules are available for adults, adolescents and children who weigh at least 33 kg and can swallow hard capsules.
Emtriva 200 mg trde kapsule so na voljo odraslim, mladostnikom in otrokom, katerih teža je najmanj 33 kg in lahko pogoltnejo trdo kapsulo.
Emtriva oral solution is particularly suitable for people who have difficulty in swallowing Emtriva hard capsules.
Peroralna raztopina Emtriva je še zlasti primerna za bolnike, ki imajo težave s požiranjem trdih kapsul Emtriva.
If you forget to take Emtriva
Če ste pozabili vzeti zdravilo Emtriva
Emtricitabine did not exhibit cytotoxicity to peripheral blood mononuclear cells (PBMCs), established lymphocyte and monocyte-macrophage cell lines or bone marrow progenitor cells in vitro.
Emtricitabin ni izkazal citotoksičnosti za periferne mononuklearne krvne celice (PBMC, peripheral blood mononuclear cells), etablirane limfocite, monocitne-makrofagne celične linije ali matične celice kostnega mozga pri in vitro pogojih.
Pharmacokinetic parameters were determined following administration of a single dose of 200 mg emtricitabine hard capsules to 30 non-HIV infected subjects with varying degrees of renal insufficiency.
Farmakokinetični parametri so bili določeni po uporabi enega odmerka 200 mg emtricitabina v obliki trdih kapsul pri 30 osebah, ki niso bile okužene z virusom HIV in so imele različne stopnje ledvične insuficience.
Patients with renal impairment: Emtricitabine is eliminated by renal excretion and exposure to emtricitabine was significantly increased in patients with renal insufficiency.
Bolniki z motnjami v delovanju ledvic: Emtricitabin se izloča preko ledvic in izpostavljenost emtricitabinu je pomembno narasla pri bolnikih z ledvično insuficienco.
Age Pharmacokinetic data are not available in the elderly (over 65 years of age).
Farmakokinetični podatki zdravila pri starostnikih (starih nad 65 let), niso na razpolago.
What you need to know before you take Emtriva Do not take Emtriva
Kaj morate vedeti, preden boste vzeli zdravilo Emtriva Ne jemljite zdravila Emtriva
With the exception of famciclovir and tenofovir disoproxil fumarate, the effect of co-administration of emtricitabine with medicinal products that are excreted by the renal route, or other medicinal products known to affect renal function, has not been evaluated.
Z izjemo famciklovira in dizoproksiltenofovirata fumarata niso bili ovrednoteni učinki sočasne uporabe emtricitabina z zdravili, ki se izločajo po ledvični poti, ali z drugimi zdravili, za katera je znano, da vplivajo na ledvično funkcijo.
In a pilot study in children and a definitive bioequivalence study in adults, the Emtriva 10 mg/mL oral solution was shown to have approximately 80% of the bioavailability of the Emtriva 200 mg hard capsules.
V pilotski študiji pri otrocih in bioekvivalentni študiji pri odraslih je biološka uporabnost Emtriva 10 mg/ml peroralne raztopine predstavljala približno 80 % biološke uporabnosti Emtriva 200 mg trdih kapsul.
Do not give Emtriva to infants under 4 months of age.
Zdravila Emtriva ne dajajte dojenčkom, starim manj kot 4 mesece.
This medicine also contains 480 mg propylene glycol per 24 mL (maximum single dose) which is equivalent to a maximum of 12 mg/kg/day.
To zdravilo vsebuje tudi 480 mg propilenglikola na 24 ml (največji enkratni odmerek), kar ustreza največ 12 mg/kg/dan.
Although the etiology 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.
Čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo CART ali obojim.
The recommended dose is: • Adults: one 200 mg hard capsule, each day with or without food.
Priporočeni odmerek je: • Odrasli: ena 200 mg trda kapsula dnevno z ali brez hrane.
There is no experience of the use of emtricitabine in patients who are failing their current regimen or who have failed multiple regimens.
Ni izkušenj z uporabo emtricitabina pri bolnikih, ki niso uspeli s dotedanjim režimom zdravljenja ali niso uspeli z različnimi režimi zdravljenja.
Antiviral activity in vitro: The 50% inhibitory concentration (IC50) value for emtricitabine against laboratory and clinical isolates of HIV-1 was in the range of 0.0013 to 0.5 µmol/l.
Antivirusno učinkovanje in vitro: 50 % inhibitorna koncentracija (IC50) vrednost emtricitabina proti laboratorijskim in kliničnim izolatom virusa HIV-1 je bila v razponu od 0,0013 do 0,5 µmol/l.
Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ.
Emtricitabin je šibek zaviralec sesalske DNA-polimeraze α, β in ε ter mitohondrijske DNA-polimeraze γ.
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/mL.
In vitro je bila vezava emtricitabina na humane plazemske proteine manj kot 4 % in je neodvisna od koncentracije v razponu med 0,02 in 200 µg/ml.
Emtriva 200 mg hard capsules are only suitable for patients who weigh at least 33 kg. Emtriva oral solution is available for people who have difficulty in swallowing Emtriva hard capsules.
Emtriva 200 mg trde kapsule so primerne le za bolnike, ki tehtajo najmanj 33 kg. Peroralna raztopina Emtriva je na voljo za bolnike, ki imajo težave s požiranjem trdih kapsul Emtriva.
Each blister pack contains 30 hard capsules.
Vsak pretisni omot vsebuje 30 trdih kapsul.
Skin discolouration (increased pigmentation): Skin discolouration, manifested by hyperpigmentation mainly on the palms and/or soles, was generally mild, asymptomatic and of little clinical significance.
Sprememba obarvanosti kože (povečana pigmentacija): Sprememba obarvanosti kože, ki se kaže kot hiperpigmentacija zlasti na dlaneh in/ali podplatih, je bila povečini blage oblike, asimptomatična in klinično le malo pomembna.
Emtriva is also available as hard capsules.
Zdravilo Emtriva je na razpolago tudi v obliki trdih kapsul.
Emtricitabine exposure may be markedly increased in patients with severe renal insufficiency (creatinine clearance < 30 mL/min) receiving daily doses of 200 mg emtricitabine as hard capsules or 240 mg as the oral solution.
Izpostavljenost emtricitabinu se lahko pomembno poveča pri bolnikih z resno ledvično insuficienco (očistek kreatinina < 30 ml/min), ki prejemajo dnevni odmerek 200 mg emtricitabina v obliki trdih kapsul ali 240 mg v obliki peroralne raztopine.
There is no clinical experience as yet on the co-administration of cytidine analogues.
Ni kliničnih izkušenj o sočasni uporabi analogov citidina.
The absolute bioavailability of emtricitabine from Emtriva 200 mg hard capsules was estimated to be 93% and the absolute bioavailability from Emtriva 10 mg/mL oral solution was estimated to be 75%.
Ocenjena absolutna biološka uporabnost emtricitabina, uporabljenega v obliki Emtriva 200 mg trde kapsule, je 93 % in ocenjena absolutna vrednost biološke uporabnosti emtricitabina, uporabljenega v obliki Emtriva 10 mg/ml peroralne raztopine, je 75 %.
Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination.
Celični encimi fosforilirajo emtricitabin v emtricitabin 5'-trifosfat, ki kompetitivno inhibira HIV-1 reverzno transkriptazo, kar rezultira v prekinitvi verige DNA.
Each dose (24 mL) contains 36 mg methyl parahydroxybenzoate (E218), 3.6 mg propyl parahydroxybenzoate (E216), 1.2 mg sunset yellow (E110), 480 mg propylene glycol and has a sodium content of 36 mg.
Vsak odmerek (24 ml) vsebuje 36 mg metilparahidroksibenzoata (E218), 3,6 mg propilparahidroksibenzoata (E216), 1,2 mg oranžnega FCF (E110), 480 mg propilenglikola in 36 mg natrija.
The safety and efficacy of the reduced doses provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.
Varnost in učinkovitost zmanjšanega odmerka, kot je prikazano v poglavju 4.2, temeljita na farmakokinetičnih podatkih pri enkratnem odmerku in modeliranju ter še nista bili klinično ovrednoteni.
If you take more Emtriva than you should
Če ste vzeli večji odmerek zdravila Emtriva, kot bi smeli
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) which works by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the HIV virus to reproduce itself.
Emtricitabin je nukleozidni zaviralec reverzne transkriptaze (NRTI, nucleoside reverse transcriptase inhibitor), ki deluje tako, da vpliva na normalno delovanje encima (reverzne transkriptaze), ki je bistven za reproduciranje virusa HIV.
Emtriva should not be taken with any other medicinal products containing emtricitabine or medicinal products containing lamivudine.
Zdravila Emtriva se ne sme jemati z nobenimi drugimi zdravili, ki vsebujejo emtricitabin ali zdravili,
Children given emtricitabine also experienced changes in skin colour including darkening of the skin in patches, very commonly and anaemia (low red blood cell count), commonly.
Pri otrocih, ki so prejemali emtricitabin, je bila zelo pogosta tudi sprememba obarvanosti kože, vključujoč temne lise in pogosta anemija (nizko število rdečih krvnih telesc).
Liver function
Ledvična funkcija
The safety and efficacy of the dose interval adjustment guidelines provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.
Varnost in učinkovitost smernic prilagoditve intervala odmerjanja, ki so predstavljene v poglavju 4.2, temeljita na farmakokinetičnih podatkih pri enkratnem odmerku in modeliranju ter še nista bili klinično ovrednoteni.
At 48 weeks of treatment the emtricitabine-containing regimen demonstrated an equivalent proportion of patients with HIV RNA < 400 copies/mL (94% emtricitabine versus 92%) and a greater proportion of patients with HIV RNA < 50 copies/mL (95% emtricitabine versus 87%) compared with the patients continuing with their PI-HAART regimen.
V času 48-tedenskega režima zdravljenja, ki je vsebovalo emtricitabin, se je izkazal ekvivalentni delež bolnikov s HIV RNA < 400 virionov/ml (94 % z emtricitabinom proti 92 %) in večji delež bolnikov s HIV RNA < 50 virionov/ml (95 % emtricitabina proti 87 %) v primerjavi z bolniki, ki so nadaljevali s svojim PI-HAART režimom.
Before starting treatment, your doctor may order blood tests to assess kidney function and may advise you to take the capsules less often or prescribe Emtriva oral solution.
Pred začetkom zdravljenja bo zdravnik morda naredil krvne preiskave, da bo ocenil delovanje ledvic in vam morda svetoval, da jemljete kapsule manj pogosto ali vam bo predpisal peroralno raztopino Emtriva.
Assessment of adverse reactions in paediatric patients from clinical study data is based on experience in three paediatric studies (n = 169) where treatment-naïve (n = 123) and treatment-experienced (n = 46) paediatric HIV infected patients aged 4 months to 18 years were treated with emtricitabine in combination with other antiretroviral agents.
Ugotavljanje neželenih reakcij pri pediatričnih bolnikih iz podatkov kliničnih študij temelji na izkušnjah treh pediatričnih študij (n = 169), v katerih so bili pediatrični bolniki, okuženi z virusom HIV, ki se zdravijo prvič (n = 123), in bolniki pediatrični, okuženi z virusom HIV, ki se zdravijo že dalj časa (n = 46), v starosti od 4 mesecev do 18 let, zdravljeni z emtricitabinom v kombinaciji z drugo protiretrovirusno učinkovino.
HIV/HBV co-infected patients: The adverse reaction profile in patients co-infected with HBV is similar to that observed in patients infected with HIV without co-infection with HBV.
Bolniki s hkratno okužbo HIV/HBV: Neželene reakcije pri bolnikih, ki so hkrati okuženi še s HBV, so podobne tistim, ki jih imajo bolniki, okuženi z virusom HIV brez hkratne okužbe s HBV.
If a patient misses a dose of Emtriva 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.
Če bolnik izpusti odmerek zdravila Emtriva 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.
Emtricitabine is primarily excreted via glomerular filtration and active tubular secretion.
Emtricitabin se primarno izloča preko glomerularne filtracije in aktivne tubularne sekrecije.
Paediatric population: The recommended dose of Emtriva for children aged 4 months and over and adolescents up to 18 years of age weighing at least 33 kg who are able to swallow hard capsules is one 200 mg hard capsule, taken orally, once daily.
Pediatrična populacija: Priporočeni odmerek zdravila Emtriva za otroke, stare 4 mesece ali več in mladostnike, stare do 18 let, s telesno težo najmanj 33 kg, ki lahko pogoltnejo trdo kapsulo, je ena 200 mg trda kapsula, peroralno, enkrat dnevno.