natgillin/translations-raw huggingface dataset:
Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Po peroralni uporabi zdravila je razpolovna doba izločanja tenofovirja približno 12 do 18 ur.
It is not known whether emtricitabine or tenofovir can be removed by peritoneal dialysis.
Ni znano, ali se lahko emtricitabin oziroma tenofovir odstranita s peritonealno dializo.
If you have taken Emtricitabine/Tenofovir disoproxil Mylan during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Če ste zdravilo Emtricitabin/dizoproksiltenofovirat Mylan jemali med nosečnostjo, vas lahko zdravnik naroči na redne preiskave krvi in druge diagnostične preiskave, da bo spremljal razvoj vašega otroka.
Use for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status.
Uporaba za zaščito pred izpostavitvijo pri posameznikih z neznanim ali pozitivnim statusom okužbe s HIV-1.
• If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the virus to the baby in breast milk.
• Če ste ženska, okužena z virusom HIV, je priporočljivo, da ne dojite, da s tem preprečite prenos virusa preko mleka na dojenčka.
There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
Obstajajo poročila o mitohondrijski disfunkciji pri HIV-negativnih dojenčkih, ki so bili in utero in/ali postnatalno izpostavljeni nukleozidnim analogom; ta so pretežno zadevala zdravljenje z režimi, ki vsebujejo zidovudin.
Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Študije o vplivu na sposobnost razmnoževanja na podganah in zajcih niso pokazale učinkov na parjenje, plodnost, nosečnost ali plod.
As a general rule, it is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV to the infant.
Splošno priporočilo je, naj s HIV okužene ženske v nobenem primeru ne dojijo, da se prepreči prenos HIV na dojenčka.
Stopping use of this medicine, or missing doses, may increase your risk of getting HIV infection.
Prenehanje uporabe tega zdravila ali izpuščeni odmerki lahko povečajo tveganje za pridobitev okužbe s HIV.
• increased creatinine in your blood
• povišan kreatinin v krvi
Patients infected with HBV who discontinue emtricitabine/tenofovir disoproxil therapy should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Bolniki z okužbo s HBV, ki prekinejo zdravljenje z emtricitabinom/dizoproksiltenofoviratom, potrebujejo natančno spremljanje z ustreznimi kliničnimi in laboratorijskimi preiskavami še vsaj nekaj mesecev po prenehanju zdravljenja.
In individuals at risk for renal disease more frequent monitoring of renal function is required.
Pri posameznikih z dejavniki tveganja za okvaro ledvic je potrebno pogostejše spremljanje delovanja ledvic.
• other allergic reactions, such as wheezing, swelling or feeling light-headed
• druge alergijske reakcije, kot so piskanje, otekanje ali omotičnost
• breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells
• razpad mišičnega tkiva, bolečine v mišicah ali mišična oslabelost, ki se lahko pojavi zaradi poškodovanja celic ledvičnih tubulov
This medicine is not a cure for HIV infection.
Zdravilo ne ozdravi okužbe z virusom HIV.
b Relative risk reduction calculated for mITT based on incident seroconversion, ie, occurring post-baseline through first posttreatment visit (approximately 1 month after last study drug dispensation).
b Relativno zmanjšanje tveganja, izračunano za mITT na osnovi dogodka serokonverzije, tj. pojava po izhodišču študije do prvega obiska po zdravljenju (približno 1 mesec po prejemu zadnjega odmerka preiskovanega zdravila).
In vitro studies have shown that both emtricitabine and tenofovir can be fully phosphorylated when combined together in cells.
In vitro študije so pokazale, da se lahko tako emtricitabin kot tenofovir popolnoma fosforilirata v celicah, ko se uporabita v kombinaciji.
• rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches
• izpuščaji (vključno z rdečimi pikami ali ogrci, včasih z mehurjasto in oteklo kožo), kar je lahko alergijska reakcija, srbečica, sprememba obarvanosti kože, vključujoč temne lise
Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 mL/min/1.73 m2.
Sedem bolnikov je imelo ocenjene vrednosti hitrosti glomerularne filtracije (GFR, glomerular filtration rate) med 70 in 90 ml/min/1,73 m².
Number with Tenofovir Detected/ Total Samples (%)
Število zaznanih primerov tenofovirja/skupno vzorci (%)
In general, emtricitabine pharmacokinetics in HBV infected subjects were similar to those in healthy subjects and in HIV infected patients.
Na splošno so bile farmakokinetične lastnosti emtricitabina pri osebah, okuženih z virusom HBV zelo podobne tistim pri zdravih osebah in bolnikih, okuženih z virusom HIV.
Pre-exposure prophylaxis (PrEP):
Zaščita pred izpostavitvijo (Pre-exposure prophylaxis - PrEP):
Seroconversions / N
Serokonverzija/N
Emtricitabine/tenofovir disoproxil should only be used in individuals with creatinine clearance (CrCl) <80 mL/min if the potential benefits are considered to outweigh the potential risks.
Zdravilo Emtricitabin/dizoproksiltenofovirat Mylan se sme uporabljati samo pri posameznikih z očistkom kreatinina (CrCl) < 80 ml/min, če se oceni, da morebitne koristi odtehtajo morebitna tveganja.
Combination of emtricitabine and tenofovir disoproxil: Genotoxicity and repeated dose toxicity studies of one month or less with the combination of these two components found no exacerbation of toxicological effects compared to studies with the separate components.
Kombinacija emtricitabina in dizoproksiltenofovirata: V študijah genotoksičnosti ali študijah s ponavljajočim se odmerkom, ki so trajale en mesec ali manj z uporabo kombinacije teh dveh učinkovin niso ugotovili poslabšanja toksikoloških vplivov, v primerjavi s posameznima učinkovinama.
The film-coated tablet can be disintegrated in approximately 100 mL of water, orange juice or grape juice and taken immediately.
Filmsko obloženo tableto se lahko raztopi v približno 100 ml vode, pomarančnega ali grozdnega soka.
• Bone problems.
• Težave s kostmi.
• Take this medicine every day to reduce your risk, not just when you think you have been at risk of HIV infection.
• To zdravilo vzemite vsak dan, da zmanjšate tveganje, in ne le takrat, ko menite, da obstaja tveganje za okužbo z virusom HIV.
Renal and bone effects in the paediatric population
Učinki na kosti in ledvice pri pediatrični populaciji
The safety profile of emtricitabine and tenofovir disoproxil in this study was consistent with the previous experience with these agents when each was administered with other antiretroviral agents.
Varnostni profil emtricitabina in dizoproksiltenofovirata v tej študiji je bil skladen s predhodnimi izkušnjami s tema učinkovinama, ko so bolniki vsako od njiju prejemali z drugimi protiretrovirusnimi zdravili.
• Talk to your doctor if you are over 65.
• Če ste starejši od 65 let, se posvetujte z zdravnikom.
Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Rezultati študij izvedenih na podganah in opicah so pokazala z učinkovino povezano zmanjšanje absorpcije fosfata v črevesju s potencialno sekundarnim zmanjšanjem BMD.
If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor may order blood tests to closely monitor your kidney function.
Če za zdravljenje HIV jemljete drugo protivirusno zdravilo, ki se imenuje zaviralec proteaze, bo vaš zdravnik morda naročil krvne preiskave z namenom natančnega spremljanja delovanja vaših ledvic.
The 48-week primary endpoint data showed that the combination of emtricitabine, tenofovir disoproxil and efavirenz provided superior antiviral efficacy as compared with the fixed combination of lamivudine and zidovudine with efavirenz as shown in Table 4.
Podatki za primarni cilj po 48 tednih so pokazali, da je imela kombinacija emtricitabina, dizoproksiltenofovirata in efavirenza večjo protivirusno učinkovitost kot fiksna kombinacija lamivudina in zidovudina z efavirenzom, kot je prikazano v preglednici 4.
Patients with hepatitis B or C virus infection
Bolniki, okuženi z virusom hepatitisa B ali C
elevated serum aspartate aminotransferase (AST) and/or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia increased transaminases
zvišana serumska aspartataminotransferaza (AST) in/ali zvišana serumska alanin-aminotransferaza (ALT), hiperbilirubinemija povišane transaminaze
• deep rapid breathing
• globoko, hitro dihanje
Additional risk minimisation measures
• Dodatni ukrepi za obvladovanje tveganja
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Pri nekaterih bolnikih z napredovalo okužbo s HIV (AIDS) in preteklimi oportunističnimi okužbami (okužbe, do katerih pride pri ljudeh s šibkim imunskim sistemom) se lahko pojavijo vnetni znaki in simptomi preteklih okužb po začetku zdravljenja okužbe s HIV.
The incidences of HIV seroconversion overall and in the subset reporting unprotected receptive anal intercourse are shown in Table 6.
Pojavnosti serokonverzije HIV na splošno in v podskupini (nezaščiten receptivni analni spolni odnos) sta prikazani v preglednici 6.
The difference in the proportion of patients who maintained < 400 copies/mL at week 48 was mainly influenced by the higher number of discontinuations in the tenofovir disoproxil treatment group.
Na razliko v deležu bolnikov, ki so ohranili < 400 kopij/ml v 48. tednu, so pretežno vplivale prekinitve v skupini zdravljenja z dizoproksiltenofoviratom.
In addition to the adverse reactions reported in adults, anaemia (9.5%) and skin discolouration (31.8%) occurred more frequently in clinical trials in paediatric patients than in adults (see section 4.8, Tabulated summary of adverse reactions).
Poleg neželenih učinkov, o katerih so poročali pri odraslih, sta se anemija (9,5 %) in obarvanje kože (31,8 %) pogosteje pojavljala v kliničnih preskušanjih pri pediatričnih bolnikih kot pri odraslih (glejte poglavje 4.8, Povzetek neželenih učinkov, prikazan v preglednici).
If you have kidney problems, your doctor may advise you to stop taking emtricitabine/tenofovir disoproxil or, if you already have HIV, to take emtricitabine/tenofovir disoproxil less frequently.
Če imate ledvične težave, vam zdravnik lahko svetuje, da emtricitabin/dizoproksiltenofovirat prenehate jemati ali, če ste že okuženi s HIV, da emtricitabin/dizoproksiltenofovirat uporabljate manj pogosto.
Table 2: Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products
Preglednica 2: Interakcije med emtricitabinom/dizoproksiltenofoviratom ali njegovo(-imi) posamično(-imi) učinkovino(-ami) in drugimi zdravili
• Emtricitabine/Tenofovir disoproxil Mylan is also used to reduce the risk of getting HIV-1 infection in adults, and adolescents aged 12 years to less than 18 years who weigh at least 35 kg, when used as a daily treatment, together with safer sex practices:
• Zdravilo Emtricitabin/dizoproksiltenofovirat Mylan se uporablja tudi za zmanjšanje tveganja za okužbo z virusom HIV-1 pri odraslih in mladostnikih, starih od 12 do 18 let, ki tehtajo vsaj 35 kg, kadar se uporablja za vsakodnevno zdravljenje, ob hkratnem upoštevanju varnega spolnega vedenja:
• If you have hepatitis B, it is especially important not to stop your treatment with Emtricitabine/Tenofovir disoproxil Mylan without talking to your doctor first.
• Če ste okuženi s hepatitisom B, je še zlasti pomembno, da ne prenehate z zdravljenjem z zdravilom Emtricitabin/dizoproksiltenofovirat Mylan, ne da bi se prej posvetovali z zdravnikom.
The systemic clearance of emtricitabine averaged 307 mL/min.
Sistemski očistek emtricitabina je v povprečju 307 ml/min.
Following intravenous administration, the volume of distribution of emtricitabine and tenofovir was approximately 1.4 L/kg and 800 mL/kg, respectively.
Po intravenskem odmerku je volumen porazdelitve emtricitabina znašal približno 1,4 l/kg in volumen porazdelitve tenofovirja približno 800 ml/kg.
Adherence Substudy Participantsb Placebo
Sodelujoči v podštudiji adherenceb Placebo
A small clinical study was conducted to evaluate the safety, antiviral activity and pharmacokinetics of tenofovir disoproxil in combination with emtricitabine in HIV infected patients with renal impairment.
Izvedena je bila majhna klinična študija za ocenitev varnosti, protivirusne aktivnosti in farmakokinetike dizoproksiltenofovirata v kombinaciji z emtricitabinom pri bolnikih, okuženih z virusom HIV z ledvično okvaro.
insomnia, abnormal dreams
nespečnost, nenavadne sanje
Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Po peroralni uporabi zdravila je razpolovna doba izločanja emtricitabina približno 10 ur.
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Za nadzor lipidov in glukoze v krvi je treba upoštevati veljavne smernice za zdravljenje okužbe z virusom HIV.
Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%).
Emtricitabin se primarno izloča preko ledvic - celoten odmerek se izolira iz urina (približno 86 %) in iz blata (približno 14 %).
These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings.
Te ugotovitve je treba upoštevati pri vseh otrocih, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom, pri katerih se pojavijo resne klinične ugotovitve neznanega vzroka, še zlasti nevrološke.
Exacerbations of hepatitis after discontinuation of treatment: In HBV infected patients, clinical and laboratory evidence of hepatitis have occurred after discontinuation of treatment (see section 4.4).
Poslabšanje hepatitisa po prekinitvi zdravljenja: Pri bolnikih, okuženih z virusom HBV, so se po prekinitvi zdravljenja pokazali klinični in laboratorijski znaki hepatitisa (glejte poglavje 4.4).
However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Vendar je pri teh bolnikih, kot pričakovano, pogostejši porast AST in ALT, kot pri bolnikih, okuženih samo z virusom HIV.
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in randomised controlled clinical studies (n = 1,563) or tenofovir disoproxil in randomised controlled clinical trials and the expanded access program (n = 7,319).
Kategorija pogostnosti je bila ocenjena s statističnim izračunom na podlagi skupnega števila bolnikov, izpostavljenih emtricitabinu v randomiziranih kontroliranih kliničnih študijah (n = 1.563) ali dizoproksiltenofoviratu v randomiziranih kontroliranih kliničnih študijah in podaljšanem programu dostopanja (n = 7.319).
• If you are an adult taking this medicine to reduce the risk of getting HIV, take this medicine every day, not just when you think you have been at risk of HIV infection.
• Če ste odrasli in to zdravilo jemljete za zmanjšanje tveganja za okužbo s HIV, jemljite to zdravilo vsak dan, ne le takrat, ko menite, da obstaja tveganje za okužbo z virusom HIV.
Both of these active substances are antiretroviral medicines which are used to treat HIV
Obe zdravilni učinkovini sta protiretrovirusni zdravili, ki se uporabljata za zdravljenje okužbe z virusom HIV.
However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself.
Oba sta splošno znana pod imenom nukleozidni zaviralci reverzne transkriptaze (NRTI, nucleoside reverse transcriptase inhibitors) in delujeta tako, da vplivata na normalno delovanje encima (reverzne transkriptaze), ki je bistven za reproduciranje virusa.
Before and during treatment, your doctor may order blood tests to measure kidney function.
Pred in med zdravljenjem bo zdravnik morda naredil krvne preiskave, da bo preveril delovanje ledvic.
In vitro protein binding of tenofovir to plasma or serum protein was less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 μg/mL.
In vitro je bila vezava tenofovirja na plazemske proteine manjša od 0,7 % oziroma na serumske proteine manjša od 7,2 % v koncentracijskem območju tenofovirja od 0,01 do 25 µg/ml.
Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products are listed in Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.” and once daily as “q.d.”).
Interakcije med emtricitabinom/dizoproksiltenofoviratom ali njegovo(-imi) posamično(-imi) učinkovino(-ami) in drugimi zdravili so navedene v preglednici 2 spodaj (povečanje je označeno z znakom ''↑'', zmanjšanje z ''↓'', brez spremembe z ''↔'', dvakrat na dan z ''b.i.d.''
• joint aches and pains (especially of the hip, knee and shoulder)
• bolečine v sklepih (zlasti v kolku, kolenu in rami)
However, tenofovir disoproxil reduced the viability index and weight of pups in a peri and postnatal toxicity study at maternally toxic doses.
Vendar pa je dizoproksiltenofovirat zmanjšal indeks življenjskih funkcij in težo mladičkov v peri- in postnatalni študiji toksičnosti pri odmerkih, toksičnih za mater.
• Do not share or re-use needles or other injection or drug equipment.
• Ne delite igel ali drugih pripomočkov za injiciranje in pripomočkov za ostale oblike jemanja drog ter jih ne uporabljajte ponovno.
Additive to synergistic effects were observed in combination studies with protease inhibitors, and with nucleoside and non-nucleoside analogue inhibitors of HIV reverse transcriptase.
Aditivne do sinergistične učinke so opazili v študijah kombinacije z zaviralci proteaz in z nukleozidnimi in nenukleozidnimi analogi zaviralcev HIV reverzne transkriptaze.
Medis International a.s vyrobani zavod Bolatice,Prumyslova, -961/16, Bolatice 747 23, Czech Republic
Medis International a.s, vyrobani zavod Bolatice, Prumyslova, -961/16, Bolatice, 747 23, Češka
Emtricitabine/tenofovir disoproxil has not been studied in HIV-1 uninfected individuals with creatinine clearance < 60 mL/min and is therefore not recommended for use in this population.
Emtricitabina/dizoproksiltenofovirata niso preučevali pri posameznikih, ki niso okuženi s HIV-1 in imajo očistek kreatinina < 60 ml/min, zato se ne priporoča za uporabo pri tej populaciji.
Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Emtricitabin tudi ni inhibiral uridin-5'-difosfoglukuronil-transferaze, encima, ki je odgovoren za glukuronidacijo.
However, in some HIV-1 infected patients, declines in creatinine clearance did not completely resolve despite tenofovir disoproxil discontinuation.
Vendar pa pri nekaterih bolnikih s HIV-1 upad očistka kreatinina ni povsem izzvenel kljub prekinitvi zdravljenja z dizoproksiltenofoviratom.
The mean changes in CD4 cell count from baseline were +185 cells/mm3 and +196 cells/mm3 respectively.
Srednje spremembe števila celic CD4 so bile od začetka študije +185 celic/mm3 in +196 celic/mm3.
Oral carcinogenicity studies in rats and mice only revealed a low incidence of duodenal tumours at an extremely high dose in mice.
Študije peroralne kancerogenosti na podganah in miših so pokazale le nizko incidenco tumorjev na dvanajstniku pri izjemno visokem odmerku pri miših.
** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count TLOVR = Time to Loss of Virologic
** Vrednost p temelji na Cochran-Mantel-Haenszlovem testu, stratificiranem za število celic CD4 na začetku študije.
Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Emtricitabin trifosfat in tenofovir difosfat kompetitivno inhibirata HIV-1 reverzno transkriptazo, kar rezultira v prekinitvi verige DNA.
Administration every 48 hours is recommended based on modelling of singledose pharmacokinetic data for emtricitabine and tenofovir disoproxil in non-HIV infected subjects with varying degrees of renal impairment (see section 4.4).
Priporočljiv je odmerek vsakih 48 ur, kar temelji na podatkih o farmakokinetiki enkratnih odmerkov za emtricitabin in dizoproksiltenofovirat pri osebah, ki niso okužene s HIV, z različnimi stopnjami ledvične okvare (glejte poglavje 4.4).
b Substudy participants received active adherence monitoring, e.g. unannounced home visits and pill counts, and counselling to improve compliance with study drug.
b Sodelujoče v podštudiji so spremljali glede aktivne adherence, npr. nenajavljeni domači obiski in štetje tablet.
Discontinuation of emtricitabine/tenofovir disoproxil therapy in patients infected with HBV may be associated with severe acute exacerbations of hepatitis.
Prekinitev zdravljenja z emtricitabinom/dizoproksiltenofoviratom pri bolnikih z okužbo s HBV je lahko povezana s hudimi akutnimi poslabšanji hepatitisa.
Possible serious side effects:
Možni resni neželeni učinki:
URAI = unprotected receptive anal intercourse
URAI = nezaščiten receptivni analni spolni odnos
There is close structural similarity between lamivudine and emtricitabine and similarities in the pharmacokinetics and pharmacodynamics of these two agents.
Med lamivudinom in emtricitabinom obstaja velika strukturna podobnost in tudi podobnosti v farmakokinetiki in farmakodinamiki teh dveh zdravil.
Emtricitabine-resistant viruses with the M184V/I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir and zidovudine.
Virusi odporni na emtricitabin z mutacijo M184V/I so bili navzkrižno odporni na lamivudin, a so ohranili občutljivost za didanozin, stavudin, tenofovir in zidovudin.
Adherence Substudy
Podštudija adherence
Therefore, the same problems may be seen if emtricitabine/tenofovir disoproxil is administered with a third nucleoside analogue.
Zato je možno opaziti enake težave pri jemanju emtricitabina/dizoproksiltenofovirata s tretjim analogom nukleozidov.
Administration of emtricitabine/tenofovir disoproxil with food resulted in a delay of approximately three quarters of an hour in reaching maximum tenofovir concentrations and increases in tenofovir AUC and Cmax of approximately 35% and 15%, respectively, when administered with a high fat or light meal, compared to administration in the fasted state.
Jemanje emtricitabina/dizoproksiltenofovirata s hrano se je odražalo v približno tričetrturni zakasnitvi pri doseganju maksimalne koncentracije tenofovirja ter povečanju AUC tenofovirja za približno 35 % in Cmax za približno 15 % pri jemanju ob z maščobami bogatem ali lažjem obroku, v primerjavi z jemanjem na tešče.
• problems with digestion resulting in discomfort after meals, feeling bloated, flatulence
• prebavne motnje, ki privedejo do slabega počutja po zaužitem obroku, občutek napihnjenosti,
Excipient with known effect
Pomožna snov z znanim učinkom