FrancophonIA/ELRC3.0 huggingface dataset:
English: What Emtricitabine/Tenofovir disoproxil Zentiva looks like and contents of the pack
Croatian: Kako Emtricitabine/Tenofovir disoproxil Zentiva izgleda i sadržaj pakiranja
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Croatian: Metabolički parametri Tijekom antiretrovirusne terapije mogu se povećati tjelesna težina i povisiti razina lipida i glukoze u krvi (vidjeti dio 4.4).
English: See also under Co-administration of other medicinal products below.
Croatian: Vidjeti i dio „Istovremena primjena drugih lijekova“ u nastavku.
English: Use of Emtricitabine/Tenofovir disoproxil Zentiva should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
Croatian: Potrebno je izbjegavati primjenu lijeka Emtricitabine/Tenofovir disoproxil Zentiva uz istovremenu ili nedavnu primjenu nefrotoksičnihg lijekova (vidjeti dio 4.5).
English: In study GS-US-104-0321, 87 HIV-1 infected treatment-experienced patients 12 to < 18 years of age were treated with tenofovir disoproxil (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
Croatian: U ispitivanju GS-US-104-0321, 87 prethodno liječenih bolesnika u dobi od 12 do < 18 godina zaraženih virusom HIV-1 primalo je tenofovirdizoproksil (n = 45) ili placebo (n = 42) u kombinaciji s optimiziranom osnovnom terapijom tijekom 48 tjedana.
English: Involved in Transactional Sex Last 6 Month, N (%) Known HIV+ Partner Last 6 Months, N (%) Syphilis Seroreactivity, N (%) Serum Herpes Simplex Virus Type 2 Infection, N (%) Urine Leukocyte Esterase Positive, N (%) URAI = unprotected receptive anal intercourse
Croatian: Poznati HIV+ partner u zadnjih 6 mjeseci, N (%) Seroreaktivnost na sifilis, N (%)
English: A subgroup of patients with baseline creatinine clearance between 50 and 60 ml/min, receiving once daily dosing, had a 2 - 4-fold increase in tenofovir exposure and worsening renal function.
Croatian: 50 i 60 ml/min, koji su primali dozu jedanput na dan, imala je 2-4 puta veću izloženost tenofoviru i pogoršanje funkcije bubrega.
English: The Partners PrEP clinical study (CO-US-104-0380) evaluated emtricitabine/tenofovir disoproxil, tenofovir disoproxil 245 mg, or placebo in 4,758 HIV-uninfected subjects from Kenya or Uganda in serodiscordant heterosexual couples.
Croatian: Kliničko ispitivanje Partners PrEP (CO-US-104-0380) procijenilo je emtricitabin/tenofovirdizoproksil, tenofovirdizoproksil u dozi od 245 mg ili placebo u 4758 ispitanika koji nisu bili zaraženi HIV-om iz
English: • If you take Emtricitabine/Tenofovir disoproxil Zentiva for treatment of HIV infection, stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Croatian: Nemojte prestati uzimati Emtricitabine/Tenofovir disoproxil Zentiva • Ako uzimate lijek Emtricitabine/Tenofovir disoproxil Zentiva radi liječenja infekcije virusom HIV-a, prestanak uzimanja tableta može smanjiti učinkovitost terapije protiv HIV-a koju Vam je preporučio liječnik.
English: Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Croatian: sofosbuvirom/velpatasvirom ili sofosbuvirom, velpatasvirom i voksilaprevirom povećava koncentraciju tenofovira u plazmi, osobito kad se primjenjuje zajedno s režimom za liječenje HIV-a koji sadrži tenofovirdizoproksil i farmakokinetički pojačivač (ritonavir ili kobicistat).
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Croatian: generalizirane i/ili žarišne mikobakterijske infekcije te upala pluća uzrokovana s Pneumocystis jirovecii.
English: No new adverse reactions to emtricitabine/tenofovir disoproxil were identified from two randomised placebo-controlled studies (iPrEx, Partners PrEP) in which 2,830 HIV-1 uninfected adults received emtricitabine/tenofovir disoproxil once daily for pre-exposure prophylaxis.
Croatian: U dva randomizirana, placebom kontrolirana ispitivanja (iPrEx, Partners PrEP) u kojima je 2830 odraslih koji nisu bili zaraženi virusom HIV 1 primalo emtricitabin/tenofovirdizoproksil jedanput na dan za predekspozicijsku profilaksu nisu bile utvrđene nove nuspojave emtricitabina/tenofovirdizoproksila.
English: Patients in the emtricitabine and tenofovir disoproxil group were given emtricitabine/tenofovir disoproxil and efavirenz from week 96 to week 144.
Croatian: Bolesnici u skupini koja je primala emtricitabin i tenofovirdizoproksil dobivali su od 96. do 144. tjedna kombinaciju emtricitabin/tenofovirdizoproksil i efavirenz.
English: If clinical symptoms consistent with acute viral infection are present and recent (< 1 month) exposures to HIV-1 are suspected, use of Emtricitabine/Tenofovir disoproxil Zentiva should be delayed for at least one month and HIV-1 status reconfirmed before starting Emtricitabine/Tenofovir disoproxil Zentiva for pre-exposure prophylaxis.
Croatian: (< 1 mjeseca) izloženost virusu HIV-1, primjenu lijeka Emtricitabine/Tenofovir disoproxil Zentiva treba odgoditi za najmanje mjesec dana i ponovno provjeriti HIV-1 status prije početka primjene lijeka Emtricitabine/Tenofovir disoproxil Zentiva za predekspozicijsku profilaksu.
English: Emtricitabine/ tenofovir disoproxil/ efavirenz*
Croatian: Emtricitabin / tenofovirdizoproksil / efavirenz*
English: Emtricitabine/Tenofovir disoproxil Zentiva should not be administered concomitantly with adefovir dipivoxil.
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva ne smije se primjenjivati istovremeno s adefovirdipivoksilom.
English: No dose adjustment is recommended.
Croatian: Ne preporučuje se prilagodba doze
English: Emtricitabine/Tenofovir disoproxil Zentiva should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide or other cytidine analogues, such as lamivudine (see section 4.4).
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva ne smije se primjenjivati istovremeno s drugim lijekovima koji sadrže emtricitabin, tenofovirdizoproksil, tenofoviralafenamid ili druge analoge citidina, kao što je lamivudin (vidjeti dio 4.4).
English: Antimycobacterials Rifampicin/tenofovir disoproxil
Croatian: Antimikobakterijski lijekovi Rifampicin/tenofovirdizoproksil
English: • joint aches and pains (especially of the hip, knee and shoulder)
Croatian: Znakovi osteonekroze su: ukočenost zglobova bol u zglobovima (osobito u kuku, koljenu i ramenu) otežana pokretljivost
English: • aminoglycosides (for bacterial infection).
Croatian: • aminoglikozide (za bakterijsku infekciju)
English: It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil Zentiva.
Croatian: Važno je da ne propustite uzeti dozu lijeka Emtricitabine/Tenofovir disoproxil Zentiva.
English: Emtricitabine/Tenofovir disoproxil Zentiva should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or other cytidine analogues, such as lamivudine (see section 4.5).
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva ne smije se primjenjivati istovremeno s drugim lijekovima koji sadrže emtricitabin, tenofovirdizoproksil, tenofoviralafenamid ili drugim analozima citidina, kao što je lamivudin (vidjeti dio 4.5).
English: • PrEP educational brochure for prescribers entitled ‘Important Safety Information for Prescribers
Croatian: • Edukacijska brošura o predekspozicijskoj profilaksi za propisivače, s naslovom „Važne informacije za propisivače o sigurnosti primjene lijeka Emtricitabine/Tenofovir disoproxil
English: Tell your doctor about any flu-like illness - either in the month before starting
Croatian: Obavijestite svog liječnika o svakoj bolesti nalik gripi - bilo u mjesecu prije početka ili bilo kada tijekom uzimanja lijeka Emtricitabine/Tenofovir disoproxil Zentiva.
English: If a dose of Emtricitabine/Tenofovir disoproxil Zentiva is missed within 12 hours of the time it is usually taken, Emtricitabine/Tenofovir disoproxil Zentiva should be taken as soon as possible and the normal dosing schedule should be resumed.
Croatian: Ako bolesnik propusti uzeti dozu lijeka Emtricitabine/Tenofovir disoproxil Zentiva, a prošlo je manje od 12 sati od uobičajenog vremena uzimanja, Emtricitabine/Tenofovir disoproxil Zentiva treba uzeti što prije i zatim nastaviti uzimati lijek prema uobičajenom rasporedu.
English: • ganciclovir (for viral infection).
Croatian: • ganciklovir (za virusnu infekciju)
English: If vomiting occurs more than 1 hour after taking Emtricitabine/Tenofovir disoproxil Zentiva a second dose should not be taken.
Croatian: Ako povraćanje nastupi nakon više od 1 sata od uzimanja lijeka Emtricitabine/Tenofovir disoproxil Zentiva, nije potrebno uzeti drugu dozu.
English: Table 6: Efficacy in study CO-US-104-0288 (iPrEx)
Croatian: Tablica 6: Djelotvornost u ispitivanju CO-US-104-0288 (iPrEx) Placebo
English: Renal function (creatinine clearance and serum phosphate) should be evaluated prior to initiating Emtricitabine/Tenofovir disoproxil Zentiva for treatment of HIV-1 or for pre-exposure prophylaxis, and should be monitored during use as in adults (see above).
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva za liječenje infekcije virusom HIV-1 ili predekspozicijsku profilaksu i treba je pratiti tijekom primjene kao u odraslih osoba (vidjeti gore).
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/Tenofovir disoproxil Zentiva use.
Croatian: Ako se posumnja na abnormalnosti funkcije bubrega ili ih se otkrije, potrebno je konzultirati se s nefrologom o mogućnosti prekida liječenja lijekom Emtricitabine/Tenofovir disoproxil
English: • Provides information on how to store Emtricitabine/Tenofovir disoproxil Zentiva.
Croatian: • pruža informacije o tome kako čuvati lijek Emtricitabine/Tenofovir disoproxil Zentiva.
English: No dose adjustment of tacrolimus is required.
Croatian: Nije potrebna prilagodba doze takrolimusa.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Emtricitabine/Tenofovir disoproxil Zentiva in either adolescent patients for the treatment of HIV-1 infection or in adults and adolescents for PrEP are provided with a physician educational pack containing the Summary of Product Characteristics and an appropriate educational brochure, as detailed below:
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva, bilo adolescentnim bolesnicima za liječenje infekcije virusom HIV 1, bilo odraslim osobama i adolescentima za predekspozicijsku profilaksu, dobiju edukacijski paket za liječnike koji sadrži sažetak opisa svojstava lijeka i odgovarajuće edukacijske brošure, kako je detaljno opisano niže: • Edukacijska brošura o HIV-u i renalnoj funkciji u djece
English: Tenofovir disoproxil 245 mg + Emtricitabine/ tenofovir disoproxil
Croatian: Tenofovirdizoproksil u dozi od 245 mg + emtricitabin/tenofovir dizoproksil
English: • That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving tenofovir disoproxil, renal function should be re-evaluated within one week.
Croatian: • Ako su u bilo kojeg pedijatrijskog bolesnika koji prima tenofovirdizoproksil fosfati u serumu <3,0 mg/dL (0,96 mmol/L), unutar jednoga tjedna treba ponovno procijeniti funkciju bubrega.
English: • dizziness, headache,
Croatian: • omaglica, glavobolja • osip
English: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg / 245 mg film-coated tablets
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg/245 mg filmom obložene tablete
English: AUC: ↓ 12% (↓ 16 to ↓ 8) Cmax: ↓ 16% (↓ 22 to ↓ 10) Cmin: ↓ 15% (↓ 12 to ↓ 9)
Croatian: AUC: ↓ 12% (↓ 16 - ↓ Cmax: ↓ 16% (↓ 22 - ↓ Cmin: ↓ 15% (↓ 12 - ↓
English: HIV-1 expressing three or more thymidine analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced susceptibility to tenofovir disoproxil.
Croatian: HIV-1 koji je eksprimirao tri ili više mutacija povezanih s analogom timidina (engl. thymidine analoque associated mutations, TAMs) koje su uključivale mutaciju reverzne transkriptaze M41L ili
English: * Patients receiving emtricitabine, tenofovir disoproxil and efavirenz were given emtricitabine/tenofovir disoproxil plus efavirenz from week 96 to 144.
Croatian: 41 (4% do 79) * Bolesnici koji su primali emtricitabin, tenofovirdizoproksil i efavirenz dobivali su od 96. do 144. tjedna kombinaciju emtricitabina/tenofovirdizoproksila plus efavirenz.
English: • Do not breast-feed during treatment with Emtricitabine/Tenofovir disoproxil Zentiva.
Croatian: • Nemojte dojiti tijekom liječenja lijekom Emtricitabine/Tenofovir disoproxil Zentiva.
English: • inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney tubule cells.
Croatian: • upala bubrega, mokrenje velikih količina mokraće i osjećaj žeđi, zatajenje bubrega, oštećenje stanica bubrežnih kanalića
English: In an open-label randomised clinical study (GS-01-934), antiretroviral-naïve 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 zidovudine administered twice daily and efavirenz once daily (n = 254).
Croatian: tenofovirdizoproksil i efavirenz po režimu doziranja jedanput na dan (n = 255) ili fiksnu kombinaciju lamivudina i zidovudina dvaput na dan uz efavirenz jedanput na dan (n = 254).
English: • That use of Emtricitabine/Tenofovir disoproxil Zentiva should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Croatian: Treba izbjegavati primjenu lijeka Emtricitabine/Tenofovir disoproxil Zentiva istovremeno s primjenom ili nakon nedavne primjene nefrotoksičnih lijekova.
English: • foscarnet (for viral infection).
Croatian: • foskarnet (za virusnu infekciju)
English: Seroconversions / Nb a ‘Case' = HIV seroconverter; ‘Cohort' = 100 randomly selected subjects from each of the tenofovir disoproxil 245 mg and emtricitabine/tenofovir disoproxil groups.
Croatian: = osoba sa serokonverzijom HIV-a; ‘Kohorta = 100 nasumično odabranih ispitanika iz skupine koja je primala tenofovirdizoproksil u dozi od 245 mg i skupine koja je primala emtricitabin/tenofovirdizoproksil.
English: • drowsiness,
Croatian: mučnina proljev,
English: Moreover, the reversibility of renal toxicity after cessation of tenofovir disoproxil for treatment of HIV-1 or after cessation of emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis cannot be fully ascertained.
Croatian: HIV-1 ili nakon prestanka primjene emtricitabina/tenofovirdizoproksila za predekspozicijsku profilaksu ne može se sa sigurnošću utvrditi.
English: • fatty liver,
Croatian: • masna jetra
English: Cmin: ↑ 29% (↑ 15 to ↑ 44)
Croatian: Cmin: ↑ 29% (↑ 15
English: AUC: ↑ 6% (↓ 1 to ↑ 13) Cmax: ↑13% (↑ 1 to ↑ 27)
Croatian: AUC: ↑ 6% (↓ 1 - ↑ 13) Cmax: ↑13% (↑ 1 - ↑ 27)
English: GS-01-934 Treatment for 144 weeks
Croatian: GS-01-934
English: Female
Croatian: Muški Ženski
English: Emtricitabine/ tenofovir disoproxil/ efavirenz
Croatian: Emtricitabin / tenofovirdizoproksil / efavirenz
English: • weakness beginning in the hands and feet and moving up towards the trunk of the body,
Croatian: mišićne slabosti slabosti koja počinje u šakama i stopalima i napreduje prema trupu osjećaja lupanja srca, nevoljnog drhtanja ili hiperaktivnosti
English: How to store Emtricitabine/Tenofovir disoproxil Zentiva
Croatian: Kako uzimati Emtricitabine/Tenofovir disoproxil Zentiva
English: • pain in the abdomen (tummy) caused by inflammation of the pancreas,
Croatian: • bol u trbuhu uzrokovana upalom gušterače
English: • Children commonly experienced low red blood cell count (anaemia).
Croatian: • Djeca su često imala nizak broj crvenih krvnih zrnaca (anemija), zbog čega mogu biti umorna i osjećati nedostatak zraka
English: Adefovir dipivoxil and Emtricitabine/Tenofovir disoproxil Zentiva should not be administered concomitantly (see section 4.4).
Croatian: Adefovirdipivoksil i Emtricitabine/Tenofovir disoproxil Zentiva ne smiju se primjenjivati istovremeno (vidjeti dio 4.4).
English: No dose adjustment of efavirenz is required.
Croatian: Nije potrebna prilagodba doze efavirenza.
English: If Emtricitabine/Tenofovir disoproxil Zentiva is coadministered with an NSAID, renal function should be monitored adequately.
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva primjenjuje istovremeno s NSAIL-om, potrebno je na odgovarajući način kontrolirati funkciju bubrega.
English: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg/245 mg film-coated tablets Emtricitabine/tenofovir disoproxil
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg/245 mg filmom obložene tablete emtricitabin/tenofovirdizoproksil
English: • increased creatinine in your blood,
Croatian: • smanjenu razinu kalija u krvi • povišenu razinu kreatinina u krvi
English: Emtricitabine/Tenofovir disoproxil Zentiva contains sodium
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva sadrži natrij
English: AUC: ↓ 4% (↓ 9 to ↑ 0) Cmax: ↓ 6% (↓ 13 to ↑ 0) Cmin: ↓ 2% (↓ 9 to ↑ 6)
Croatian: AUC: ↓ 4% (↓ 9 - ↑ 0) Cmax: ↓ 6% (↓ 13 - ↑ 0) Cmin: ↓ 2% (↓ 9 - ↑ 6)
English: • swelling of the face, lips, tongue or throat,
Croatian: • oticanje lica, usana, jezika ili grla • anemija (nizak broj crvenih krvnih stanica)
English: Neither emtricitabine nor tenofovir inhibited in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation.
Croatian: Ni emtricitabin ni tenofovir in vitro nisu inhibirali metabolizam lijekova posredovan bilo kojim od glavnih humanih
English: The use of emtricitabine/tenofovir disoproxil is not recommended in individuals under the age of 18 years with renal impairment (see section 4.2).
Croatian: Ne preporučuje se primjena lijeka Emtricitabine/Tenofovir disoproxil Zentiva u osoba s oštećenjem bubrega mlađih od 18 godina (vidjeti dio 4.2).
English: AUC: ↓ 27% (↓ 35 to ↓ 18) Cmax: ↓ 37% (↓ 48 to ↓ 25)
Croatian: AUC: ↓ 27% (↓ 35 - ↓ Cmax: ↓ 37% (↓ 48 - ↓
English: Renal and urinary disorders Uncommon increased creatinine, proteinuria, proximal renal tubulopathy including Fanconi syndrome
Croatian: Manje često povišene vrijednosti kreatinina, proteinurija, proksimalna bubrežna tubulopatija uključujući Fanconijev sindrom
English: HIV-1 RNA < 400 copies/ml (TLOVR)
Croatian: HIV-1 RNK < 400 kopija/ml (TLOVR) p-vrijednost % razlike (95% CI)
English: AUC: ↑ 4% (↓ 3 to ↑ 11) Cmax: ↑ 3% (↓ 3 to ↑ 9)
Croatian: AUC: ↑ 4% (↓ 3 - ↑ 11) Cmax: ↑ 3% (↓ 3 - ↑ 9)
English: the BMD Z-scores observed in subjects who switched to tenofovir disoproxil were lower than those observed in subjects who remained on their stavudine- or zidovudine-containing regimen (see sections 4.4 and 5.1).
Croatian: U djece (u dobi od 2 do 15 godina) zaražene virusom HIV-1, z-vrijednosti BMD-a bile su niže u ispitanika koji su prešli na liječenje tenofovirdizoproksilom nego u ispitanika koji su ostali na režimu liječenja stavudinom ili zidovudinom (vidjeti dijelove 4.4 i 5.1).
English: • Provides information on how to take Emtricitabine/Tenofovir disoproxil Zentiva
Croatian: • pruža informacije o tome kako uzimati lijek Emtricitabine/Tenofovir disoproxil Zentiva
English: Cmin: NC Ethinyl oestradiol:
Croatian: Cmin: NI Etinilestradiol:
English: Ribavirin/tenofovir disoproxil
Croatian: Ribavirin/tenofovirdizoproksil
English: AUC: ↑96% (↑74 to ↑121) Cmax: ↑68% (↑54 to ↑84) Cmin: ↑118% (↑91 to ↑150)
Croatian: AUC: ↑96% (↑74Cmax: ↑68% (↑54 - ↑84) Cmin: ↑118% (↑91
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14)
Croatian: AUC: ↑ 5% (↓ 2 - ↑ 13) Cmax: ↑ 5% (↓ 3 - ↑ 14)
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24)
Croatian: AUC: ↓ 34% (↓ 41 - ↓ Cmax: ↓ 34% (↓ 41 - ↑ Cmin: ↓ 34% (↓ 43 - ↑
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10)
Croatian: AUC: ↓ 25% (↓ 42 - ↓ Cmax: ↓ 28% (↓ 50 - ↑ Cmin: ↓ 26% (↓ 46 - ↑
English: Cmin: ↑ 39% (↑ 20 to ↑ 61)
Croatian: Cmin: ↑ 39% (↑ 20
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosinerelated adverse reactions.
Croatian: Istovremena primjena tenofovirdizoproksila i didanozina rezultira 40 - 60%-tnim povećanjem sistemske izloženosti didanozinu,
English: AUC: ↑ 40% (↑ 34 to ↑ 45) Cmax: ↑ 46% (↑ 39 to ↑ 54) Cmin: ↑ 70% (↑ 61 to ↑ 79)
Croatian: AUC:↑40% (↑34 - ↑45) Cmax:↑46% (↑ 39 - ↑54) Cmin: ↑70% (↑61 - ↑79)
English: Recommendation concerning co-administration with Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Croatian: Preporuka za istovremenu primjenu s lijekom Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabin 200 mg, tenofovirdizoproksil 245 mg)
English: AUC: ↑ 32% (↑ 25 to ↑ 38) Cmax: ↔
Croatian: AUC: ↑ 32% (↑ 25 - ↑ Cmax: ↔
English: Mixed/Other
Croatian: Miješani/drugi Azijati
English: Age (Yrs), Mean (SD)
Croatian: Dob (godine), srednja vrijednost (SD) Rasa, N (%)
English: The adverse reactions considered at least possibly related to treatment with the components of emtricitabine/tenofovir disoproxil from clinical study and post-marketing experience in HIV-1 infected patients are listed in Table 3, below, by body system organ class and frequency.
Croatian: Nuspojave za koje se na temelju kliničkog ispitivanja i iskustva nakon stavljanja lijeka u promet u bolesnika zaraženih virusom HIV-1 smatra da su barem moguće povezane s liječenjem komponentama emtricitabinom i tenofovirdizoproksilom navedene su u sljedećoj tablici 3 po organskim sustavima i učestalosti.
English: AUC: ↔ Cmax: ↓ 19% (↓ 40 to ↑ 10)
Croatian: AUC: ↔ Cmax: ↓ 19% (↓ 40 - ↑
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108)
Croatian: AUC: ↓ 4% (↓ 15 - ↑ 8) Cmax: ↑ 102% (↓ 96 - ↑
English: AUC: ↑ 142% (↑ 123 to ↑ 164) Cmax: ↑ 55% (↑ 41 to ↑ 71) Cmin: ↑ 301% (↑ 257 to ↑ 350)
Croatian: AUC: ↑ 142% (↑ 123Cmax: ↑ 55% (↑ 41Cmin: ↑ 301% (↑ 257
English: Emtricitabine/ tenofovir disoproxil (n = 1,579)
Croatian: Emtricitabi n/ tenofovirdiz oproksil (n = 1579)
English: AUC: ↑ 40% (↑ 31 to ↑ 50) Cmax: ↔
Croatian: AUC: ↑40% (↑ 31 - ↑ Cmax: ↔
English: AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0)
Croatian: AUC: ↓ 11% (↓ 14 - ↓ Cmax: ↓ 7% (↓ 13 - ↓ 0)
English: Emtricitabine/Tenofovir disoproxil Zentiva should not be given to adolescents with existing kidney problems.
Croatian: Lijek Emtricitabine/Tenofovir disoproxil Zentiva se ne smije propisati adolescentima koji imaju tegobe s bubrezima.
English: Consideration should be given to interrupting treatment with Emtricitabine/Tenofovir disoproxil Zentiva in patients with creatinine clearance decreased to < 50 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l).
Croatian: Treba razmotriti mogućnost prekida liječenja lijekom Emtricitabine/Tenofovir disoproxil Zentiva u bolesnika u kojih je klirens kreatinina smanjen na < 50 ml/min ili im je vrijednost fosfata u serumu snižena na < 1,0 mg/dl
English: The mean (%CV) tenofovir drug exposure increased from 2,185 (12%) ng·h/ml in subjects with normal renal function, to 3,064 (30%) ng·h/ml, 6,009 (42%) ng·h/ml and 15,985 (45%) ng·h/ml, in subjects with mild, moderate and severe renal impairment, respectively.
Croatian: Srednja vrijednost (% CV) izloženosti tenofoviru porasla je s 2185 (12%) ng•h/ml u ispitanika s normalnom bubrežnom funkcijom na 3064 (30%) ng•h/ml, 6009 (42%) ng•h/ml te