FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro: Resistance has been seen in vitro and in some HIV-1 infected patients due to the development of the M184V/I mutation with emtricitabine or the K65R mutation with tenofovir.
Croatian: In vitro: Rezistencija je bila opažena in vitro i u nekih bolesnika zaraženih virusom HIV-1, zbog razvoja mutacije M184V/I uz emtricitabin ili mutacije K65R uz tenofovir.
English: Furthermore, in a small clinical study, a subgroup of patients with creatinine clearance between 50 and 60 mL/min who received tenofovir disoproxil in combination with emtricitabine every 24 hours had a 2-4-fold higher exposure to tenofovir and worsening of renal function (see section 5.2).
Croatian: Nadalje, u malom kliničkom ispitivanju, podskupina bolesnika s klirensom kreatinina između 50 i 60 mL/min koji su primali tenofovirdizoproksil u kombinaciji s emtricitabinom svaka 24 sata imala je za 2−4 puta veću izloženost tenofoviru i pogoršanje funkcije bubrega (vidjeti dio 5.2).
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 (9,0%) izloženih tenofovirdizoproksilu prekinulo je uzimanje ispitivanog lijeka zbog štetnih događaja povezanih s bubrezima.
English: If you are being treated for HIV infection your doctor will prescribe Emtricitabine/Tenofovir disoproxil Krka with other antiretroviral medicines.
Croatian: Ako se liječite zbog infekcije virusom HIV-a liječnik će Vam propisati lijek Emtricitabine/Tenofovir disoproxil Krka s drugim antiretrovirusnim lijekovima.
English: What Emtricitabine/Tenofovir disoproxil Krka is and what it is used for What you need to know before you take Emtricitabine/Tenofovir disoproxil Krka How to take Emtricitabine/Tenofovir disoproxil Krka Possible side effects
Croatian: Što je Emtricitabine/Tenofovir disoproxil Krka i za što se koristi Što morate znati prije nego počnete uzimati Emtricitabine/Tenofovir disoproxil Krka Kako uzimati Emtricitabine/Tenofovir disoproxil Krka Moguće nuspojave
English: 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: Ova nuspojava prepoznata je tijekom praćenja lijeka nakon stavljanja u promet, ali nije opažena u randomiziranim kontroliranim kliničkim ispitivanjima emtricitabina u odraslih ili u kliničkim ispitivanjima emtricitabina u pedijatrijskih bolesnika zaraženih HIV-om ili u randomiziranim kontroliranim ispitivanjima tenofovirdizoproksila ili programu proširenog pristupa terapiji tenofovirdizoproksilom.
English: Tenofovir disoproxil is indicated for the treatment of HBV and emtricitabine has shown activity against HBV in pharmacodynamic studies but the safety and efficacy of emtricitabine/tenofovir disoproxil have not been specifically established in patients with chronic HBV infection.
Croatian: Tenofovir dizoproksil je indiciran za liječenje HBV-a, a farmakodinamička ispitivanja pokazala su da emtricitabin djeluje protiv HBV-a, no sigurnost i djelotvornost emtricitabin/tenofovirdizoproksila nisu posebno ustanovljene u bolesnika s kroničnom infekcijom HBV-om.
English: , myopathy
Croatian: , miopatija
English: Relative Risk Reduction (95% CI)
Croatian: Smanjenje relativnog rizika (95% CI)
English: Discontinuation of Emtricitabine/Tenofovir disoproxil Krka therapy in patients infected with HBV may be associated with severe acute exacerbations of hepatitis.
Croatian: Prekid terapije lijekom Emtricitabine/Tenofovir disoproxil Krka u bolesnika zaraženih HBV-om može biti povezan s teškim akutnim egzacerbacijama hepatitisa.
English: Prior to initiating Emtricitabine/Tenofovir disoproxil Krka 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 se započne terapija lijekom Emtricitabine/Tenofovir disoproxil Krka za liječenje infekcije virusom HIV-1 ili za predekspozicijsku profilaksu, preporučuje se u svih osoba izračunati klirens kreatinina.
English: 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.
Croatian: Provedeno je malo kliničko ispitivanje da bi se procijenila sigurnost primjene, antivirusno djelovanje i farmakokinetika tenofovirdizoproksila u kombinaciji s emtricitabinom u bolesnika koji su zaraženi HIV-om i imaju oštećenje funkcije bubrega.
English: While taking Emtricitabine/Tenofovir disoproxil Krka you may still develop infections or other illnesses associated with HIV infection.
Croatian: Dok uzimate lijek Emtricitabine/Tenofovir disoproxil Krka, i dalje možete razviti infekcije ili druge bolesti povezane s infekcijom virusom HIV-a.
English: In a randomised clinical study (M02-418), 190 antiretroviral-naïve adults were treated once daily with emtricitabine and tenofovir disoproxil in combination with lopinavir/ritonavir given once or twice daily.
Croatian: U randomiziranom kliničkom ispitivanju (M02-418) 190 odraslih osoba, koje prije nisu primale antiretrovirusnu terapiju, bilo je liječeno jedanput na dan emtricitabinom i tenofovirdizoproksilom u kombinaciji s lopinavirom/ritonavirom davanoj jedanput ili dvaput na dan.
English: Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day, whenever possible with food.
Croatian: - Adolescenti u dobi od 12 do manje od 18 godina tjelesne težine najmanje 35 kg: jedna tableta svaki dan, kad god je to moguće s hranom.
English: Age (Yrs), Median (Q1, Q3) Gender, N (%)
Croatian: Dob (godine), medijan (Q1, Q3)
English: In a study of 498 men, the mean changes from baseline to week 24 in BMD ranged from - 0.4% to - 1.0% across hip, spine, femoral neck and trochanter in men who received daily emtricitabine/tenofovir disoproxil prophylaxis (n = 247) vs. placebo (n = 251).
Croatian: U ispitivanju koje je uključilo 498 muškaraca, srednja vrijednost promjene BMD-a od početnih vrijednosti do vrijednosti u 24. tjednu kretala se u rasponu od - 0,4% do - 1,0% u kuku, kralježnici, vratu i trohanteru bedrene kosti u muškaraca koji su svakodnevno primali profilaksu emtricitabin/tenofovirdizoproksilom (n = 247) u odnosu na one koji su primali placebo (n = 251).
English: The increased dose interval for emtricitabine/tenofovir disoproxil in HIV-1 infected patients with moderate renal impairment is expected to result in higher peak plasma concentrations and lower Cmin levels as compared to patients with normal renal function.
Croatian: Očekuje se da će povećani interval između doza emtricitabin/tenofovirdizoproksila rezultirati u bolesnika zaraženih virusom HIV-1 s umjerenim oštećenjem funkcije bubrega višim vršnim koncentracijama u plazmi i nižim razinama Cmin u usporedbi s bolesnicima s normalnom bubrežnom funkcijom.
English: The potential renal and bone effects with long-term use of emtricitabine/tenofovir for preexposure prophylaxis in adolescents are unknown (see section 4.4).
Croatian: Mogući učinci na bubrege i kosti uz dugoročnu primjenu emtricitabina/tenofovira za predekspozicijsku profilaksu u adolescenata nisu poznati (vidjeti dio 4.4).
English: In vivo - treatment of HIV-1: In an open-label randomised clinical study (GS-01-934) in antiretroviralnaïve patients, genotyping was performed on plasma HIV-1 isolates from all patients with confirmed HIV RNA > 400 copies/mL at weeks 48, 96 or 144 or at the time of early study drug discontinuation.
Croatian: In vivo - liječenje HIV-1: U otvorenom, randomiziranom kliničkom ispitivanju (GS-01-934) na bolesnicima koji prije nisu bili liječeni antiretrovirusnim lijekovima, provedeno je određivanje genotipa na plazmatskim izolatima HIV-1 od svih bolesnika s potvrđenim HIV RNK > 400 kopija/mL u 48., 96. ili 144. tjednu ili u vrijeme prijevremenog prekida uzimanja ispitivanog lijeka.
English: The use of Emtricitabine/Tenofovir disoproxil Krka is not recommended in patients with severe renal impairment (creatinine clearance < 30 mL/min) and in patients who require haemodialysis since appropriate dose reductions cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
Croatian: Primjena lijeka Emtricitabine/Tenofovir disoproxil Krka se ne preporučuje bolesnicima s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 mL/min) i bolesnicima kojima je potrebna hemodijaliza, jer se kombiniranom tabletom ne može postići odgovarajuće smanjenje doze (vidjeti dijelove 4.2 i 5.2).
English: The combination should be used with caution with frequent renal monitoring (see section 4.4).
Croatian: Kombinacija se mora primjenjivati s oprezom uz često praćenje bubrežne funkcije (vidjeti dio 4.4).
English: Administration every 48 hours is recommended based on modelling of single-dose pharmacokinetic data for emtricitabine and tenofovir disoproxil in non-HIV infected subjects with varying degrees of renal impairment (see section
Croatian: Primjena svakih 48 sati preporučuje se na temelju modela farmakokinetičkih podataka za pojedinačnu dozu emtricitabina i tenofovirdizoproksila u ispitanika koji nisu zaraženi virusom HIV-a, s različitim stupnjevima oštećenja funkcije bubrega (vidjeti dio 4.4).
English: Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine.
Croatian: Istovremena primjena tenofovirdizoproksila i didanozina u dozi od 400 mg na dan povezana je sa značajnim smanjenjem broja CD4 stanica, moguće zbog intracelularne interakcije koja povećava fosforilirani (tj. aktivni) didanozin.
English: * Patients receiving emtricitabine, tenofovir disoproxil and efavirenz were given emtricitabine/tenofovir disoproxil plus efavirenz from week 96 to 144.
Croatian: * Bolesnicima koji su primali emtricitabin, tenofovirdizoproksil i efavirenz, davan je emtricitabin/tenofovirdizoproksil plus efavirenz od 96. do 144. tjedna.
English: - Emtricitabine/Tenofovir disoproxil Krka should always be used combined with other medicines to treat HIV infection.
Croatian: - Emtricitabine/Tenofovir disoproxil Krka se uvijek mora uzimati u kombinaciji s drugim lijekovima za liječenje HIV infekcije.
English: Lamivudine and
Croatian: Lamivudin i
English: If you take Emtricitabine/Tenofovir disoproxil Krka for treatment of HIV infection, stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Croatian: - Ako uzimate Emtricitabine/Tenofovir disoproxil Krka radi liječenja infekcije virusom HIV-a, prestanak uzimanja tableta može smanjiti učinkovitost terapije protiv HIV-a koju Vam je preporučio liječnik.
English: The rate of HIV-1 seroconversion in males was 0.24/100 person-years of emtricitabine/tenofovir disoproxil exposure and the rate of HIV-1 seroconversion in females was 0.95/100 person-years of emtricitabine/tenofovir disoproxil exposure.
Croatian: Incidencija serokonverzije HIV-a prikazana je u Tablici 9. Stopa serokonverzije HIV-1 u muškaraca iznosila je 0,24/100 osoba-godina izloženosti emtricitabin/tenofovirdizoproksilu, a stopa serokonverzije HIV-a u žena iznosila je 0,95/100 osoba-godina izloženosti emtricitabin/tenofovirdizoproksilu.
English: Pack sizes: 30 film coated tablets (1x30) and 90 film-coated tablets (3x30).
Croatian: Veličine pakiranja: 30 filmom obloženih tableta (1 x 30) i 90 filmom obloženih tableta (3 x 30).
English: If you have kidney problems, your doctor may advise you to stop taking Emtricitabine/Tenofovir disoproxil Krka or, if you already have HIV, to take Emtricitabine/Tenofovir disoproxil Krka less frequently.
Croatian: Ako imate tegobe s bubrezima, liječnik Vam može savjetovati da prestanete uzimati lijek Emtricitabine/Tenofovir disoproxil Krka ili, ako već imate HIV, da rjeđe uzimate Emtricitabine/Tenofovir disoproxil Krka.
English: How to store Emtricitabine/Tenofovir disoproxil Krka Contents of the pack and other information
Croatian: Kako čuvati Emtricitabine/Tenofovir disoproxil Krka Sadržaj pakiranja i druge informacije
English: If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine/Tenofovir disoproxil Krka, whether or not you also have HIV.
Croatian: Ako imate HBV, postoji ozbiljan rizik od tegoba s jetrom kada prestanete uzimati Emtricitabine/Tenofovir disoproxil Krka, bez obzira na to imate li i HIV.
English: Whenever possible, Emtricitabine/Tenofovir disoproxil Krka should be taken with food.
Croatian: Kad god je to moguće, lijek Emtricitabine/Tenofovir disoproxil Krka treba uzimati s hranom.
English: The effectiveness of Emtricitabine/Tenofovir disoproxil Krka in reducing the risk of acquiring HIV-1 is strongly correlated with adherence as demonstrated by measurable drug levels in blood (see section 5.1).
Croatian: Učinkovitost lijeka Emtricitabine/Tenofovir disoproxil Krka u smanjivanju rizika od dobivanja virusa HIV-1 tijesno je povezana s pridržavanjem terapije, kako je dokazano mjerljivim razinama lijeka u krvi (vidjeti dio 5.1).
English: HIV-1 uninfected individuals should be counselled at frequent intervals to strictly adhere to the recommended Emtricitabine/Tenofovir disoproxil Krka dosing schedule.
Croatian: Osobama koje nisu zaražene virusom HIV-1 treba u čestim razmacima savjetovati da se strogo pridržavaju preporučenog dnevnog rasporeda doziranja lijeka Emtricitabine/Tenofovir disoproxil Krka.
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: Patients in the emtricitabine and tenofovir disoproxil group were given emtricitabine/tenofovir disoproxil and efavirenz from week 96 to week 144.
Croatian: Bolesnicima u skupini emtricitabin i tenofovirdizoproksil davan je emtricitabin/tenofovirdizoproksil i efavirenz od 96. do 144. tjedna.
English: The risk of HIV-1 infection should be balanced against the potential for renal and bone effects with long-term use of emtricitabine/tenofovir.
Croatian: Rizik od infekcije virusom HIV-1 treba razmotriti u odnosu na potencijalne učinke dugoročne primjene emtricitabina/tenofovira na bubrege i kosti.
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 emtricitabine/tenofovirdizoproksila za predekspozicijsku profilaksu u bolesnika s infekcijom HBV-om ili HCV-om nije ustanovljena.
English: Do not take Emtricitabine/Tenofovir disoproxil Krka to treat HIV or to reduce the risk of getting HIV if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Emtricitabine/Tenofovir disoproxil Krka za liječenje HIV-a ili smanjenje rizika od dobivanja HIV-a ako ste alergični na emtricitabin, tenofovir, tenofovirdizoproksil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
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: Treatment of HIV-1 infection: In an open-label randomised clinical study (GS-01-934), antiretroviralnaïve HIV-1 infected adult patients received either a once daily regimen of emtricitabine, tenofovir disoproxil and efavirenz (n = 255) or a fixed combination of lamivudine and zidovudineadministered twice daily and efavirenz once daily (n = 254).
Croatian: Liječenje infekcije virusom HIV-1: U otvorenom randomiziranom kliničkom ispitivanju (GS-01-934), odrasli bolesnici zaraženi s HIV-1 koji prije nisu bili liječeni antiretrovirusnom terapijom primali su ili emtricitabin, tenofovirdizoproksil i efavirenz (n = 255) po režimu doziranja jedanput na dan, ili fiksnu kombinaciju lamivudina i zidovudina davanu dva puta na dan te efavirenz jedanput na dan (n = 254).
English: ANTI-INFECTIVES Hepatitis B virus (HBV) antiviral agents Adefovir dipivoxil /Tenofovir disoproxil
Croatian: Antivirusni lijekovi za virus hepatitisa B (HBV) Adefovirdipivoksil/Tenofovirdizoproksil
English: Five subjects (5.6%) had laboratory findings clinically consistent with proximal renal tubulopathy, 4 of whom discontinued tenofovir disoproxil therapy (median tenofovir disoproxil exposure 331 weeks).
Croatian: Pet ispitanika (5,6%) imalo je laboratorijske nalaze koji klinički odgovaraju proksimalnoj bubrežnoj tubulopatiji, od koji je njih 4 prekinulo liječenje tenofovirdizoproksilom (medijan izlaganja tenofovirdizoproksilu: 331 tjedan).
English: See section 2 "Emtricitabine/Tenofovir disoproxil Krka contains lactose", "Emtricitabine/Tenofovir disoproxil Krka contains sodium".
Croatian: Vidjeti dio 2 "Emtricitabine/Tenofovir disoproxil Krka sadrži laktozu", "Emtricitabine/Tenofovir disoproxil Krka sadrži natrij".
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) ukazuju da emtricitabin i tenofovirdizoproksil ne uzrokuju malformacije i da nemaju feto/neonatalni toksični učinak.
English: In 3 of 10 subjects who had acute HIV infection at study enrollment, M184I and M184V mutations were detected in the HIV of 2 of 2 subjects in the emtricitabine/tenofovir disoproxil group and 1 of 8 subjects in the placebo group.
Croatian: U 3 od 10 ispitanika koji su pri uključenju u ispitivanje imali akutnu HIV-infekciju, mutacije M184I i M184V bile su otkrivene u virusu HIV-a u 2 od 2 ispitanika u skupini koja je primala emtricitabin/tenofovirdizoproksil i 1 od 8 ispitanika u skupini koja je primala placebo.
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, prekid liječenja se ne preporučuje jer egzacerbacija hepatitisa nakon liječenja može dovesti do dekompenzacije jetre.
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: If a dose of Emtricitabine/Tenofovir disoproxil Krka 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 se propustilo uzeti dozu lijeka Emtricitabine/Tenofovir disoproxil Krka u roku duljem od 12 sati a već je blizu vrijeme za uzimanje sljedeće doze, propuštenu dozu ne treba uzeti nego jednostavno treba nastaviti uzimati lijek prema uobičajenom rasporedu.
English: Secondary efficacy analyses over 144 weeks included the proportion of patients with HIV-1 RNA concentrations < 400 or < 50 copies/mL, and change from baseline in CD4 cell count.
Croatian: Sekundarne su analize djelotvornosti tijekom 144 tjedna uključivale udio bolesnika s HIV-1 RNK koncentracijama < 400 ili < 50 kopija/mL te promjenu broja CD4 stanica od početne vrijednosti.
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: Blood and lymphatic system disorders: Common:
Croatian: Poremećaji krvi i limfnog sustava: Često:
English: The bioequivalence of one emtricitabine/tenofovir disoproxil 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 emtricitabin/tenofovirdizoproksila s jednom tvrdom kapsulom emtricitabina od 200 mg i jednom filmom obloženom tabletom tenofovirdizoproksila od 245 mg, utvrđena je nakon primjene jednostruke doze u zdravih ispitanika natašte.
English: Cmin: ↑ 63% (↑ 45 to ↑ 84) Ritonavir:
Croatian: Cmin: ↑ 63% (↑ 45 do ↑ 84) Ritonavir:
English: Emtricitabine/Tenofovir disoproxil Krka is not for use in children under 12 years of age.
Croatian: Emtricitabine/Tenofovir disoproxil Krka nije namijenjen za primjenu u djece mlađe od 12 godina.
English: Emtricitabine/Tenofovir disoproxil Krka film coated tablets are blue, oval, biconvex tablets, of dimensions 20 mm x 10 mm.
Croatian: Emtricitabine/Tenofovir disoproxil Krka filmom obložene tablete su plave, ovalne, bikonveksne tablete veličine 20 mm x 10 mm.
English: Emtricitabine/Tenofovir disoproxil Krka is indicated in combination with safer sex practices for preexposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).
Croatian: Emtricitabine/Tenofovir disoproxil Krka je indiciran u kombinaciji s provođenjem mjera sigurnijeg spolnog odnosa za predekspozicijsku profilaksu kako bi se smanjio rizik od infekcije virusom HIV-1 prenesene spolnim putem u odraslih osoba i adolescenata s visokim rizikom (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Emtricitabine/Tenofovir disoproxil Krka with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Croatian: Lijekovi koji se eliminiraju bubrezima: Kako se emtricitabin i tenofovir primarno eliminiraju putem bubrega, istovremena primjena lijeka Emtricitabine/Tenofovir disoproxil Krka i lijekova koji smanjuju funkciju bubrega ili se natječu za aktivnu tubularnu sekreciju (npr. cidofovir) može povećati serumske koncentracije emtricitabina, tenofovira i/ili istovremeno primijenjenih lijekova.
English: Paediatric population: 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: Sigurnost i djelotvornost primjene emtricitabin/tenofovirdizoproksila u djece mlađe od 12 godina nisu ustanovljene (vidjeti dio 5.2).
English: Very common side effects (may affect more than 1 in 10 people) diarrhoea, being sick (vomiting), feeling sick (nausea) dizziness, headache rash feeling weak
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - proljev, povraćanje, mučnina - omaglica, glavobolja - osip - osjećaj slabosti
English: Emtricitabine/Tenofovir disoproxil Krka is used to treat Human Immunodeficiency Virus 1 (HIV-1) infection in adults.
Croatian: - Emtricitabine/Tenofovir disoproxil Krka se primjenjuje za liječenje infekcije virusom humane imunodeficijencije tipa 1 (HIV-1) u odraslih.