FrancophonIA/ELRC3.0 huggingface dataset:
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Croatian: Autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa) također su zabilježeni; međutim, prijavljeno vrijeme do nastupa poremećaja je različito i ti se događaji mogu pojaviti više mjeseci nakon početka liječenja
English: HIV-1 RNA < 50 copies/ml (TLOVR)
Croatian: HIV-1 RNK < 50 kopija/ml (TLOVR) p-vrijednost
English: Pharmacokinetic studies have not been performed with emtricitabine/tenofovir disoproxil in children and adolescents (under 18 years of age).
Croatian: Pedijatrijska populacija Nisu provedena farmakokinetička ispitivanja emtricitabina/tenofovirdizoproksila u djece i adolescenata (mlađih od 18 godina).
English: Emtricitabine/Tenofovir disoproxil Zentiva with food and drink
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva s hranom i pićem
English: Emtricitabine /Tenofovir disoproxil Zentiva 200 mg/245 mg film-coated tablets are blue, oval biconvex film coated tablet without half-score with dimensions approx. 19.35 x 9.75 mm.
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg/245 mg filmom obložene tablete su plave, ovalne, bikonveksne, filmom obložene tablete bez razdjelnog ureza, dimenzija približno 19,35 mm x 9,75 mm.
English: • PrEP Checklist for prescribers
Croatian: • Lista provjere kod predekspozicijske profilakse za propisivača
English: If you take more Emtricitabine/Tenofovir disoproxil Zentiva than you should
Croatian: Ako uzmete više lijeka Emtricitabine/Tenofovir disoproxil Zentiva nego što ste trebali
English: • Emtricitabine/Tenofovir disoproxil Zentiva 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,
Croatian: • Emtricitabine/Tenofovir disoproxil Zentiva također se primjenjuje za smanjenje rizika od dobivanja infekcije virusom HIV-1 u odraslih, te adolescenata u dobi od 12 godina do manje od 18 godina, tjelesne težine najmanje 35 kg, kad se uzima svakodnevno, zajedno s provođenjem mjera sigurnijih spolnih odnosa:
English: Table 3: Tabulated summary of adverse reactions associated with the individual components of emtricitabine / tenofovir disoproxil based on clinical study and post-marketing experience
Croatian: Tablica 3: Tablični prikaz nuspojava povezanih s pojedinim komponentama emtricitabinom i tenofovirdizoproksilom na temelju kliničkih ispitivanja i iskustva nakon stavljanja u promet
English: Whenever possible, Emtricitabine/Tenofovir disoproxil Zentiva should be taken with food.
Croatian: Kad god je to moguće, Emtricitabine/Tenofovir disoproxil Zentiva treba uzimati s hranom.
English: Emtricitabine/Tenofovir disoproxil Zentiva [outer packaging only]
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva [samo vanjsko pakiranje]
English: In study GS-US-104-0352, 8 out of 89 paediatric patients (9.0%) exposed to tenofovir disoproxil discontinued study drug due to renal adverse events.
Croatian: U studiji GS-US-104-0352, 8 od 89 pedijatrijskih bolesnika (9%) izloženih tenofovirdizoproksil prekinulo je uzimanje ispitivanog lijeka zbog štetnih događaja povezanih s bubrezima.
English: In 2 of 14 subjects who had acute HIV infection at study enrollment, the K65R mutation was detected in the HIV of 1 of 5 subjects in the tenofovir disoproxil 245 mg group and the M184V mutation (associated with resistance to emtricitabine) was detected in the HIV of 1 of 3 subjects in the emtricitabine/tenofovir disoproxil group.
Croatian: U 2 od 14 ispitanika koji su imali akutnu HIV-infekciju pri uključenju u ispitivanje, mutacija K65R bila je otkrivena u HIV-u kod 1 od 5 ispitanika u skupini koja je primala tenofovirdizoproksil u dozi od 245 mg, a mutacija M184V (povezana s rezistencijom na emtricitabin) bila je otkrivena u HIV-u kod 1 od 3 ispitanika u skupini koja je primala emtricitabin/tenofovirdizoproksil.
English: 1 Data generated from simultaneous dosing with ledipasvir/sofosbuvir.
Croatian: 1Podaci generirani prilikom istovremene primjene s ledipasvirom/sofosbuvirom.
English: During treatment for HIV there may be an increase in weight and in levels of blood lipids and glucose.
Croatian: Tijekom liječenja HIV-a može doći do povećanja tjelesne težine i povišenja razina lipida i glukoze u krvi.
English: Treatment of HIV-1 infection in the paediatric population There are no clinical studies conducted with emtricitabine/tenofovir disoproxil in the paediatric population with HIV-1 infection.
Croatian: Liječenje infekcije virusom HIV-1 u pedijatrijskoj populaciji Nisu provedena klinička ispitivanja lijeka Emtricitabine/Tenofovir disoproxil Zentiva u pedijatrijskoj populaciji zaraženoj virusom HIV-1.
English: Tenofovir disoproxil should be avoided in patients with HIV-1 harbouring the K65R mutation.
Croatian: Tenofovirdizoproksil je potrebno izbjegavati u bolesnika s HIV-1 koji nosi mutaciju K65R.
English: Renal safety with emtricitabine/tenofovir disoproxil has only been studied to a very limited degree in HIV-1 infected patients with impaired renal function (creatinine clearance < 80 ml/min).
Croatian: Sigurnost kombinacije emtricitabina/tenofovirdizoproksila za bubrege ispitana je samo u vrlo ograničenoj mjeri u bolesnika zaraženih virusom HIV-1 s oštećenjem funkcije bubrega (klirens kreatinina < 80 ml/min).
English: At week 48, 83% of patients in the tenofovir disoproxil treatment group and 92% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/ml.
Croatian: U 48. tjednu, 83% bolesnika u skupini koja je dobivala tenofovirdizoproksil i 92% bolesnika u skupini koja je primala stavudin ili zidovudin imalo je koncentracije HIV-1 RNK < 400 kopija/ml.
English: Risk of resistance with undetected HIV-1 infection
Croatian: Rizik od rezistencije kod neotkrivene infekcije virusom HIV-1:
English: 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.
Croatian: Osobe kojima je klirens kreatinina (CrCl) < 80 ml/min smiju uzimati emtricitabin/tenofovirdizoproksil samo ako se smatra da su moguće koristi veće od mogućih rizika.
English: Rare renal failure (acute and chronic), acute tubular necrosis, nephritis (including acute interstitial nephritis)3, nephrogenic diabetes insipidus
Croatian: nefritis (uključujući akutni intersticijski nefritis) 3, nefrogeni dijabetes insipidus
English: The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 12 years have not been established (see section 5.2).
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost emtricitabina/tenofovirdizoproksila u djece mlađe od 12 godina nisu ustanovljene (vidjeti dio 5.2).
English: Blood and lymphatic system disorders Common neutropenia
Croatian: Poremećaji krvi i limfnog sustava Često neutropenija
English: 3 This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies for emtricitabine or in randomised controlled clinical studies or the tenofovir disoproxil expanded access program for tenofovir disoproxil.
Croatian: 3 Ova je nuspojava prepoznata tijekom praćenja lijeka nakon stavljanja u promet, ali nije opažena u randomiziranim kontroliranim kliničkim ispitivanjima emtricitabina u odraslih ili kliničkim ispitivanjima emtricitabina u pedijatrijskih bolesnika zaraženih HIV-om ili u randomiziranim kontroliranim ispitivanjima tenofovirdizoproksila odnosno u programu proširenog pristupa terapiji tenofovirdizoproksilom.
English: The safety and efficacy of emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis in patients with HBV or HCV infection has not been established.
Croatian: Sigurnost i djelotvornost primjene emtricitabina/tenofovirdizoproksila za predekspozicijsku profilaksu u bolesnika s infekcijom HBV-om ili HCV-om nije ustanovljena.
English: In order to optimise the absorption of tenofovir, it is recommended that emtricitabine/tenofovir disoproxil should preferably be taken with food.
Croatian: Da bi se optimizirala apsorpcija tenofovira, emtricitabin/tenofovirdizoproksil najbolje je uzimati s hranom.
English: • Children given emtricitabine very commonly experienced changes in skin colour including
Croatian: Ostali učinci u djece • Djeca liječena emtricitabinom vrlo su često imala promjene boje kože, uključujući tamne mrlje na koži
English: The pharmacokinetics of emtricitabine have not been studied in non-HBV infected subjects with varying degrees of hepatic insufficiency.
Croatian: Farmakokinetika emtricitabina nije ispitana u ispitanika koji nisu zaraženi HBV-om, a imaju različiti stupanj insuficijencije jetre.
English: Outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 3 bottles of 30 film-coated tablets.
Croatian: Kutije koje sadrže 1 bocu s 30 filmom obloženih tableta i kutije koje sadrže 3 boce s 30 filmom obloženih tableta.
English: Store below 30°C after first opening.
Croatian: Nakon prvog otvaranja čuvati na temperaturi ispod 30°C.
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil.
Croatian: Opsežni podaci (više od 1000 trudnoća) ne ukazuju da emtricitabin i tenofovirdizoproksil ne uzrokuu malformacije i da nemaju feto/neonatalni toksični učinak.
English: Emtricitabine and tenofovir are eliminated by renal excretion and the exposure to emtricitabine and tenofovir increases in individuals with renal dysfunction (see sections 4.4 and 5.2).
Croatian: Emtricitabin i tenofovir eliminiraju se izlučivanjem putem bubrega i izloženost emtricitabinu i tenofoviru povećava se u osoba s poremećenom funkcijom bubrega (vidjeti dijelove 4.4 i 5.2).
English: The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 12 years have not been established.
Croatian: Sigurnost i djelotvornost primjene emtricitabina/tenofovirdizoproksila u djece mlađe od 12 godina nisu ustanovljene.
English: • increased creatine kinase.
Croatian: Vrlo često povišene vrijednosti kreatin kinaze
English: Emtricitabine/Tenofovir disoproxil Zentiva is not recommended if you have severe kidney disease or are on dialysis.
Croatian: Ne preporučuje se uzimanje lijeka Emtricitabine/Tenofovir disoproxil Zentiva ako imate tešku bolest bubrega ili ste na dijalizi.
English: • Just taking Emtricitabine/Tenofovir disoproxil Zentiva may not stop you getting HIV.
Croatian: • Samo uzimanje lijeka Emtricitabine/Tenofovir disoproxil Zentiva neće spriječiti da dobijete HIV.
English: What Emtricitabine/Tenofovir disoproxil Zentiva is and what it is used for Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances, emtricitabine and tenofovir disoproxil.
Croatian: Što je Emtricitabine/Tenofovir disoproxil Zentiva i za što se koristi Emtricitabine/Tenofovir disoproxil Zentiva sadrži dvije djelatne tvari, emtricitabin i tenofovirdizoproksil.
English: The potential renal and bone effects with long-term use of emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis in adolescents are unknown (see section 4.4).
Croatian: Mogući učinci na bubrege i kosti uz dugoročnu primjenu emtricitabina/tenofovirdizoproksila za predekspozicijsku profilaksu u adolescenata nisu poznati (vidjeti dio 4.4).
English: When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/ml at week 48.
Croatian: Kada su isključeni podaci koji su nedostajali, 91% bolesnika u skupini koja je dobivala tenofovirdizoproksil i 94% bolesnika u skupini koja je dobivala stavudin ili zidovudin imalo je u 48. tjednu koncentracije HIV-1 RNK < 400 kopija/ml.
English: Co-administration of sofosbuvir/velpatasvir with efavirenz-containing regimens is not recommended.
Croatian: Ne preporučuje se istovremena primjena sofosbuvira/velpatasvira s režimima koji sadrže efavirenz.
English: Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (see section 4.4).
Croatian: Neki primjeri uključuju, ali nisu ograničeni na aminoglikozide, amfotericin B, foskarnet, ganciklovir, pentamidin, vankomicin,
English: Prior to initiating Emtricitabine/Tenofovir disoproxil Zentiva for the treatment of HIV-1 infection or for use in pre-exposure prophylaxis, it is recommended that creatinine clearance is calculated in all individuals.
Croatian: Prije nego što se započne terapija lijekom Emtricitabine/Tenofovir disoproxil Zentiva za liječenje infekcije virusom HIV-1 ili za predekspozicijsku profilaksu, preporučuje se u svih osoba izračunati klirens kreatinina.
English: Emtricitabine/Tenofovir disoproxil Zentiva should only be used to reduce the risk of acquiring HIV-1 in individuals confirmed to be HIV negative (see section 4.3).
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva smije se primjenjivati samo za smanjenje rizika od dobivanja virusa HIV-1 u osoba u kojih je potvrđeno da su HIV-negativne (vidjeti dio 4.3).
English: Tenofovir exposure achieved in these paediatric patients receiving oral daily doses of tenofovir disoproxil 245 mg or 6.5 mg/kg body weight tenofovir disoproxil up to a maximum dose of 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg. Pharmacokinetic studies have not been performed with tenofovir disoproxil in children under 2 years.
Croatian: Izloženost tenofoviru postignuta u tih pedijatrijskih bolesnika koji su peroralno primali dnevne doze tenofovirdizoproksila od 245 mg ili 6,5 mg/kg tjelesne težine do maksimalne doze od 245 mg bila je slična razinama izloženosti koje se postižu u odraslih bolesnika liječenih tenofovirdizoproksilom u dozi od 245 mg jedanput na dan.
English: A decreased dosage of 250 mg didanosine coadministered with tenofovir disoproxil therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Croatian: Smanjena doza didanozina od 250 mg, primijenjena zajedno s tenofovirdizoproksilom, povezuje se s prijavama visokih stopa virološkog neuspjeha unutar nekoliko ispitanih kombinacija za liječenje infekcije virusom HIV-1.
English: Ask your doctor if you have any questions about how to prevent getting HIV or prevent spreading HIV to other people.
Croatian: Obratite se svom liječniku ako imate bilo kakvih pitanja o tome kako spriječiti dobivanje HIV-a ili prijenos HIV-a drugim osobama.
English: Emtricitabine/Tenofovir disoproxil Zentiva can only help reduce your risk of getting HIV before you are infected.
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva može Vam pomoći da smanjite rizik od dobivanja HIV-a samo prije zaraze.
English: Emtricitabine/Tenofovir disoproxil Zentiva is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva indiciran je u kombiniranoj antiretrovirusnoj terapiji za liječenje odraslih osoba zaraženih virusom HIV-1 (vidjeti dio 5.1).
English: If a dose of Emtricitabine/Tenofovir disoproxil Zentiva is missed by more than 12 hours and it is almost time for the next dose, the missed dose should not be taken and the usual dosing schedule should be resumed.
Croatian: Ako bolesnik propusti uzeti dozu lijeka Emtricitabine/Tenofovir disoproxil Zentiva za više od 12 sati, a već je blizu vrijeme za sljedeću dozu, ne smije uzeti propuštenu dozu nego treba nastaviti uzimati lijek prema uobičajenom rasporedu.
English: Emtricitabine/Tenofovir disoproxil Zentiva should not be initiated in paediatric patients with renal impairment and should be discontinued in paediatric patients who develop renal impairment during Emtricitabine/Tenofovir disoproxil Zentiva use.
Croatian: Liječenje lijekom Emtricitabine/Tenofovir disoproxil Zentiva ne smije se započeti u pedijatrijskih bolesnika s oštećenjem bubrega i mora se prekinuti u pedijatrijskih bolesnika koji tijekom primjene lijeka Emtricitabine/Tenofovir disoproxil Zentiva razviju oštećenje bubrega.
English: % difference (95% CI)
Croatian: Razlika (95% CI)
English: In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
Croatian: U bolesnika s uznapredovalom bolešću jetre ili cirozom jetre prekid liječenja se ne preporučuje jer egzacerbacija hepatitisa nakon liječenja može dovesti do dekompenzacije jetre.
English: Contents of the pack and other information What Emtricitabine/Tenofovir disoproxil Zentiva contains
Croatian: Sadržaj pakiranja i druge informacije Što Emtricitabine/Tenofovir disoproxil Zentiva sadrži
English: It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.
Croatian: Važno je i da liječniku kažete ako uzimate ledipasvir/sofosbuvir, sofosbuvir/velpatasvir ili sofosbuvir/velpatasvir/voksilaprevir za liječenje infekcije virusom hepatitisa C.
English: • Reminders on what the individual should know before and while taking Emtricitabine/Tenofovir disoproxil Zentiva to reduce the risk of getting HIV infection
Croatian: • podsjetnici o tome što osoba mora znati prije i za vrijeme uzimanja lijeka Emtricitabine/Tenofovir disoproxil Zentiva radi smanjenja rizika od dobivanja infekcije HIV-om
English: • That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil-containing products such as Emtricitabine/Tenofovir disoproxil Zentiva
Croatian: • U bolesnika zaraženih HIV-om postoji povećan rizik od bolesti bubrega povezan s lijekovima koji sadrže tenofovirdizoproksil, kao što je Emtricitabine/Tenofovir disoproxil Zentiva
English: In study GS-US-104-0352, 89 HIV-1 infected paediatric patients with a median age of 7 years (range 2 to 15 years) were exposed to tenofovir disoproxil for a median of 331 weeks.
Croatian: U ispitivanju GS-US-104-0352, 89 pedijatrijskih bolesnika zaraženih virusom HIV-1 s medijanom dobi od 7 godina (raspon: 2 do 15 godina) bilo je izloženo tenofovirdizoproksilu tijekom medijana od 331 tjedna.
English: Emtricitabine/Tenofovir disoproxil Zentiva is not for use in children under 12 years of age.
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva nije namijenjen za primjenu u djece mlađe od 12 godina.
English: Relative Risk Reduction (2-sided 95% CI)a
Croatian: Smanjenje relativnog rizika (2-strani 95% CI)a
English: The bioequivalence of one emtricitabine/tenofovir disoproxil phosphate film-coated tablet with one emtricitabine 200 mg hard capsule and one tenofovir disoproxil 245 mg film-coated tablet was established following single dose administration to fasting healthy subjects.
Croatian: Bioekvivalencija jedne filmom obložene tablete emtricitabina/tenofovirdizoproksil fosfata s jednom tvrdom kapsulom emtricitabina od 200 mg i jednom filmom obloženom tabletom tenofovirdizoproksila od 245 mg utvrđena je nakon primjene jedne doze u zdravih ispitanika natašte.
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).
Croatian: Bubrežne nuspojave u skladu s proksimalnom bubrežnom tubulopatijom zabilježene su u pedijatrijskih bolesnika u dobi od 2 do < 12 godina zaraženih virusom HIV-1 u kliničkom ispitivanju GS-US-104-0352 (vidjeti dijelove 4.8 i 5.1).
English: Assessment of adverse reactions related to tenofovir disoproxil is based on two randomised trials (studies GS-US 104-0321 and GS-US-104-0352) in 184 HIV-1 infected paediatric patients (aged 2 to < 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1).
Croatian: Procjena nuspojava povezanih s tenofovirdizoproksilom temelji se na dva randomizirana ispitivanja (GS-US-104-0321 i GS-US-104-0352) provedena na 184 pedijatrijska bolesnika zaražena virusom HIV-1 (u dobi od 2 do < 18 godina) koji su primali tenofovirdizoproksil (n = 93) ili placebo/aktivni komparator (n = 91) u kombinaciji s drugim antiretrovirusnim lijekovima tijekom 48 tjedana (vidjeti dio 5.1).
English: Pharmacokinetic parameters were mainly determined following administration of single doses of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected subjects with varying degrees of renal impairment.
Croatian: Farmakokinetički parametri određeni su uglavnom nakon primjene jednokratnih doza od 200 mg emtricitabina ili 245 mg tenofovirdizoproksila kod ispitanika koji nisu bili zaraženi HIV-om, a imali su različiti stupanj oštećenja funkcije bubrega.
English: Additive to synergistic effects were observed in combination studies with protease inhibitors, and with nucleoside and non-nucleoside analogue inhibitors of HIV reverse transcriptase.
Croatian: Aditivni do sinergistički učinci opaženi su u ispitivanjima kombinacije s inhibitorima proteaze te s nukleozidnim i nenukleozidnim analozima, inhibitorima reverzne transkriptaze HIV-a.
English: HIV-1 infected patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Croatian: Bolesnici s infekcijom virusom HIV-1 i kroničnim hepatitisom B ili C liječeni antiretrovirusnom terapijom izloženi su povećanom riziku od teških i potencijalno smrtonosnih jetrenih nuspojava.
English: • If you are taking Emtricitabine/Tenofovir disoproxil Zentiva to reduce the risk of getting HIV, take Emtricitabine/Tenofovir disoproxil Zentiva every day, not just when you think you have been at risk of HIV infection.
Croatian: • Ako uzimate Emtricitabine/Tenofovir disoproxil Zentiva radi smanjenja rizika od dobivanja HIV-a, uzimajte Emtricitabine/Tenofovir disoproxil Zentiva svaki dan, ne samo kada mislite da ste bili izloženi riziku od infekcije virusom HIV-a.
English: In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected by tenofovir and results in low-level reduced susceptibility to abacavir, emtricitabine, lamivudine and tenofovir.
Croatian: Uz to, tenofovirom je izdvojena supstitucija K70E u reverznoj transkriptazi virusa HIV-1, koja rezultira blagim smanjenjem osjetljivosti na abakavir, emtricitabin, lamivudin i tenofovir.
English: Outer carton / bottle label
Croatian: Kutija / naljepnica boce
English: Following oral administration of emtricitabine/tenofovir disoproxil to healthy subjects, emtricitabine and tenofovir disoproxil are rapidly absorbed and tenofovir disoproxil is converted to tenofovir.
Croatian: Nakon peroralne primjene emtricitabina/tenofovirdizoproksila u zdravih ispitanika, emtricitabin i tenofovirdizoproksil se vrlo brzo apsorbiraju, a tenofovirdizoproksil se pretvara u tenofovir.
English: Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 291.5 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir).
Croatian: Jedna filmom obložena tableta sadrži 200 mg emtricitabina i 245 mg tenofovirdizoproksila (što odgovara 291,5 mg tenofovirdizoproksilfosfata ili 136 mg tenofovira).
English: 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).
Croatian: U bolesnika zaraženih HBV-om, nakon prekida liječenja hepatitis se mogao klinički i laboratorijski dokazati (vidjeti dio 4.4).
English: Do not stop taking Emtricitabine/Tenofovir disoproxil Zentiva without contacting your doctor.
Croatian: Nemojte prestati uzimati Emtricitabine/Tenofovir disoproxil Zentiva bez razgovora s liječnikom.