FrancophonIA/ELRC3.0 huggingface dataset:
English: Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Croatian: Nakon peroralne primjene, poluvijek eliminacije emtricitabina je oko 10 sati.
English: If you have taken Emtricitabine/Tenofovir disoproxil Zentiva during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste uzimali Emtricitabine/Tenofovir disoproxil Zentiva tijekom trudnoće, liječnik će možda zatražiti redovito provođenje krvnih i drugih dijagnostičkih pretraga kako bi pratio razvoj djeteta.
English: 2D barcode carrying the unique identifier included.
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom.[samo vanjsko pakiranje]
English: Risk Estimate for HIV-1 Protection: Detection Versus No Detection of Tenofovir
Croatian: Procjena rizika za zaštitu od virusa HIV-1: Detektiran naspram nedetektiran tenofovir
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Croatian: U slučaju istovremene antivirusne terapije hepatitisa B ili C, pročitajte i sažetak opisa svojstava lijeka za te lijekove.
English: Age (Yrs), Median (Q1, Q3) Gender, N (%)
Croatian: Dob (godine), medijan (Q1, Q3) Spol, N (%)
English: • If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of therapy with Emtricitabine/Tenofovir disoproxil Zentiva to you and your child.
Croatian: • Ako zatrudnite ili planirate trudnoću, posavjetujte se s liječnikom o potencijalnim koristima i rizicima liječenja lijekom Emtricitabine/Tenofovir disoproxil Zentiva za Vas i dijete.
English: In general, emtricitabine pharmacokinetics in HBV infected subjects were similar to those in healthy subjects and in HIV infected patients.
Croatian: Općenito je farmakokinetika emtricitabina u osoba zaraženih HBV-om bila slična farmakokinetici u zdravih ispitanika i bolesnika zaraženih HIV-om.
English: ** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count.
Croatian: ** p-vrijednost se temeljila na Cochran-Mantel-Haenszelovu testu uslojenom prema početnom broju
English: Maximum emtricitabine and tenofovir concentrations are observed in serum within 0.5 to 3.0 h of dosing in the fasted state.
Croatian: Maksimalne koncentracije emtricitabina i tenofovira zapažaju se u serumu unutar 0,5 do 3,0 sata nakon doziranja natašte.
English: This is because the active substances in this medicine pass into human breast milk.
Croatian: Djelatne tvari iz ovog lijeka prelaze u majčino mlijeko.
English: 32 (9 to 55)
Croatian: 32 (9% do 55)
English: Physicians should refer to current HIV treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).
Croatian: Liječnici se trebaju pridržavati trenutno važećih smjernica za liječenje infekcije HIV-om u bolesnika koji su istovremeno zaraženi virusom hepatitisa B (HBV) ili virusom hepatitisa C (HCV).
English: Years living with study partner Years aware of discordant status
Croatian: Godine zajedničkog života s partnerom u ispitivanju
English: If you notice any of these symptoms tell your doctor.
Croatian: Ako primijetite bilo koji od tih simptoma, obratite se svom liječniku.
English: In vivo - pre-exposure prophylaxis
Croatian: In vivo - predekspozicijska profilaksa
English: In vitro studies have determined that neither tenofovir disoproxil nor tenofovir are substrates for the CYP450 enzymes.
Croatian: In vitro ispitivanja pokazala su da ni tenofovirdizoproksil ni tenofovir nisu supstrati za enzime CYP450.
English: b Relative risk reduction calculated for mITT based on incident seroconversion, ie, occurring post-baseline through first post-treatment visit (approximately 1 month after last study drug dispensation).
Croatian: b Smanjenje relativnog rizika izračunato za mITT na temelju incidentne serokonverzije, tj. one koja je nastupila u razdoblju nakon početka ispitivanja do prve kontrole nakon liječenja (približno 1 mjesec nakon zadnjeg izdavanja ispitivanog lijeka).
English: Patients infected with HBV who discontinue Emtricitabine/Tenofovir disoproxil Zentiva should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Croatian: Bolesnike zaražene HBV-om koji prestanu uzimati lijek Emtricitabine/Tenofovir disoproxil Zentiva treba pažljivo pratiti, uz kliničku i laboratorijsku kontrolu tijekom najmanje nekoliko mjeseci nakon prestanka liječenja.
English: The bone toxicity in young adult rats and dogs occurred at exposures ≥ 5-fold the exposure in paediatric or adult patients; bone toxicity occurred in juvenile infected monkeys at very high exposures following subcutaneous dosing (≥ 40-fold the exposure in patients).
Croatian: U mladih odraslih štakora i pasa toksičnost za kosti nastupila je pri izloženosti ≥ 5 puta većoj od izloženosti kod pedijatrijskih ili odraslih bolesnika; toksičnost za kosti pojavila se u mladih zaraženih majmuna pri vrlo visokim razinama izloženosti nakon supkutane primjene (≥ 40 puta veća izloženost nego u bolesnika).
English: If you notice any of the side effects listed above or if any of the side effects get serious, talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju od gore navedenih nuspojava ili ako neka od nuspojava postane ozbiljna, obratite se svom liječniku ili ljekarniku.
English: • decreases in phosphate in the blood,
Croatian: • smanjenu količinu fosfata u krvi
English: Blue, oval biconvex film-coated tablet without half-score with dimensions approx. 19.35 x 9.75 mm.
Croatian: Plava, ovalna, bikonveksna, filmom obložena tableta bez razdjelnog ureza, dimenzija približno 19,35 mm x 9,75 mm.
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „Rok valjanosti“.
English: • yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver,
Croatian: • žuta boja kože ili očiju, svrbež ili bol u trbuhu (abdomenu) uzrokovana upalom jetre
English: Immune system disorders Common allergic reaction
Croatian: Poremećaji imunološkog sustava Često alergijska reakcija
English: In individuals at risk for renal disease more frequent monitoring of renal function is required.
Croatian: U osoba s rizikom od bolesti bubrega potrebno je češće pratiti funkciju bubrega.
English: • That emtricitabine/tenofovir disoproxil may cause a reduction in BMD and the effects of emtricitabine/tenofovir disoproxil associated changes in BMD on long term bone health and future fracture risk are currently unknown in paediatric patients
Croatian: • Emtricitabin/tenofovirdizoproksil može izazvati smanjenje BMD-a, a učinci promjena BMD-a povezanih s lijekom Emtricitabine/Tenofovir disoproxil Zentiva na dugoročno zdravlje kosti i rizik od budućih lomova u pedijatrijskih bolesnika trenutno nisu poznati
English: • Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).
Croatian: • Tegobe s kostima (koje ponekad dovode do prijeloma) mogu se pojaviti i zbog oštećenja stanica bubrežnih tubula (vidjeti dio 4, Moguće nuspojave).
English: 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.
Croatian: No, obje su tvari općenito poznate kao nukleozidni inhibitori reverzne transkriptaze, a djeluju tako da ometaju normalan rad enzima (reverzne transkriptaze) koji je ključan za reprodukciju virusa.
English: If bone abnormalities are suspected then appropriate consultation should be obtained.
Croatian: U slučaju sumnje na abnormalnosti kosti potrebno je odgovarajuće se konzultirati.
English: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 ml/min/1.73 m2.
Croatian: Sedmero bolesnika imalo je procijenjenu brzinu glomerularne filtracije između 70 i 90 ml/min/1,73 m2.
English: Rare hepatic steatosis, hepatitis
Croatian: Rijetko hepatička steatoza,
English: Non-clinical safety pharmacology studies on tenofovir disoproxil reveal no special hazard for humans.
Croatian: Tenofovirdizoproksil Neklinička ispitivanja sigurnosne farmakologije tenofovirdizoproksila ne ukazuju na poseban rizik za ljude.
English: Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Croatian: Emtricitabin trifosfat i tenofovir difosfat kompetitivno inhibiraju reverznu transkriptazu virusa HIV-1, što rezultira prekidom lanca DNK.
English: Individuals over the age of 65 years are more likely to have decreased renal function, therefore caution should be exercised when administering Emtricitabine/Tenofovir disoproxil Zentiva to older people.
Croatian: Kod osoba starijih od 65 godina veća je vjerojatnost da imaju smanjenu funkciju bubrega, pa je stoga potreban oprez kad se Emtricitabine/Tenofovir disoproxil Zentiva primjenjuje kod starijih osoba.
English: The iPrEx study (CO-US-104-0288) evaluated emtricitabine/tenofovir disoproxil or placebo in 2,499 HIV uninfected men (or transgender women) who have sex with men and who were considered at high risk for HIV infection.
Croatian: Ispitivanje iPrEx (CO-US-104-0288) procijenilo je emtricitabin/tenofovirdizoproksil ili placebo u 2499 muškaraca (ili transrodnih žena) koji nisu bili zaraženi HIV-om koji su imali spolne odnose s muškarcima i za koje se smatralo da imaju visok rizik od infekcije HIV-om.
English: Limited data from clinical studies support once daily dosing in HIV-1 uninfected individuals with CrCl 60-80 ml/min.
Croatian: Ograničeni podaci iz kliničkih ispitivanja govore u prilog doziranju jedanput na dan u osoba koje nisu zaražene virusom HIV-1 i imaju CrCl 60-80 ml/min.
English: 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.
Croatian: Vezivanje tenofovira za proteine u plazmi i serumu in vitro bilo je manje od 0,7% odnosno 7,2%, u rasponu koncentracija tenofovira od 0,01 do 25 µg/ml.
English: • If you have hepatitis B, it is especially important not to stop your Emtricitabine/Tenofovir disoproxil Zentiva treatment without talking to your doctor first.
Croatian: • Ako imate hepatitis B, naročito je važno da se ne prestanete liječiti lijekom Emtricitabine/Tenofovir disoproxil Zentiva, a da prije toga niste razgovarali s liječnikom.
English: 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.
Croatian: U nekih bolesnika s uznapredovalom HIV-infekcijom (SIDA) i oportunističkim infekcijama u povijesti bolesti (infekcije koje nastaju u osoba s oslabljenim imunološkim sustavom), ubrzo nakon početka uzimanja lijekova za liječenje HIV-infekcije mogu se pojaviti znakovi i simptomi upale od prethodnih infekcija.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 μg/ml.
Croatian: Vezivanje emtricitabina za proteine u ljudskoj plazmi in vitro iznosilo je < 4% i nije ovisilo o koncentraciji u rasponu od 0,02 do 200 µg/ml.
English: • Lactic acidosis (see Possible serious side effects)
Croatian: • laktacidoza (pogledajte dio „Moguće ozbiljne nuspojave“)
English: Therefore, the same problems may be seen if Emtricitabine/Tenofovir disoproxil Zentiva is administered with a third nucleoside analogue.
Croatian: Stoga se mogu uočavati isti problemi ako se Emtricitabine/Tenofovir disoproxil Zentiva daje s nekim trećim analogom nukleozida.
English: Therefore the use of Emtricitabine/Tenofovir disoproxil Zentiva may be considered during pregnancy, if necessary.
Croatian: Stoga se može razmotriti primjena lijeka Emtricitabine/Tenofovir disoproxil Zentiva tijekom trudnoće, ako je neophodno.
English: If you accidentally take more than the recommended dose of Emtricitabine/Tenofovir disoproxil Zentiva, contact your doctor or nearest emergency department for advice.
Croatian: Ako slučajno uzmete veću dozu lijeka Emtricitabine/Tenofovir disoproxil Zentiva od preporučene, obratite se svom liječniku ili najbližoj hitnoj službi.
English: However, tenofovir disoproxil reduced the viability index and weight of pups in a peri and postnatal toxicity study at maternally toxic doses.
Croatian: Ipak, tenofovirdizoproksil smanjio je indeks preživljenja i težinu mladunčadi u perinatalnom i postnatalnom ispitivanju toksičnosti pri dozama toksičnima za majku.
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant cap and induction heat sealing (with aluminium foil) containing 30 film-coated tablets and a silica gel desiccant (in a HDPE container).
Croatian: Boca od polietilena visoke gustoće (HDPE) s polipropilenskim zatvaračem sigurnim za djecu i zalijepljenim zaštitnim pokrovom (s aluminijskom folijom) koja sadrži 30 filmom obloženih tableta i silika-gel kao sredstvo za sušenje (u HDPE spremniku).
English: Dose interval adjustments are recommended for HIV-1 infected patients with creatinine clearance 30-49 ml/min (see section 4.2).
Croatian: Preporučuje se prilagođavanje intervala doziranja kod bolesnika zaraženih virusom HIV-1 s klirensom kreatinina 30 - 49 ml/min (vidjeti dio 4.2).
English: Didanosine/emtricitabine
Croatian: Didanozin/emtricitabin
English: Hepatobiliary disorders Common elevated serum aspartate aminotransferase (AST) and/or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia increased transaminases
Croatian: Često povišene serumske vrijednosti aspartat aminotransferaze (AST) i/ili povišene serumske vrijednosti alanin aminotransferaze (ALT), hiperbilirubinemija povišene vrijednosti transaminaza
English: At baseline the randomised groups had similar median plasma HIV-1 RNA (5.02 and 5.00 log10 copies/ml) and CD4 counts (233 and 241 cells/mm3).
Croatian: Na početku su randomizirane skupine imale sličan medijan plazmatske vrijednosti HIV-1 RNK (5,02 i 5,00 log10 kopija/ml) i broja CD4 stanica (233 i 241 stanica/mm3).
English: While taking Emtricitabine/Tenofovir disoproxil Zentiva you may still develop infections or other illnesses associated with HIV infection.
Croatian: Dok uzimate Emtricitabine/Tenofovir disoproxil Zentiva i dalje možete razvijati infekcije ili druge bolesti koje su povezane s HIV-infekcijom.
English: Decreases in BMD of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil treatment group at 144 weeks.
Croatian: Smanjenja BMD-a kralježnice i promjene koštanih bioloških biljega od početne vrijednosti bila su značajno veća u skupini liječenoj tenofovirdizoproksilom u 144. tjednu.
English: However, in some HIV-1 infected patients, declines in creatinine clearance did not completely resolve despite tenofovir disoproxil discontinuation.
Croatian: Međutim, u nekih se bolesnika zaraženih virusom HIV-1 smanjenje klirensa kreatinina nije potpuno riješilo usprkos prekidu terapije tenofovirdizoproksilom.
English: Baseline characteristics are summarised in Table 8.
Croatian: Početne značajke sažeto su prikazane u tablici 8.
English: Missing doses may increase your risk of getting HIV infection.
Croatian: Propuštanje doza može povećati rizik od dobivanja HIV-infekcije.
English: Use is not recommended in HIV-1 uninfected individuals with CrCl < 60 ml/min as it has not been studied in this population (see sections 4.4 and 5.2).
Croatian: Primjena se ne preporučuje u osoba koje nisu zaražene virusom HIV-1 i imaju CrCl < 60 ml/min jer nije ispitana u ovoj populaciji (vidjeti dijelove 4.4 i 5.2).
English: Baseline characteristics are summarised in Table 5.
Croatian: Početne značajke sažeto su prikazane u tablici 5.
English: • Reminder on the risk of development of HIV-1 drug resistance in undiagnosed HIV-1-Infected individuals
Croatian: • podsjetnik o riziku od razvoja rezistencije virusa HIV-1 na lijekove u nedijagnosticiranih osoba zaraženih virusom HIV-1
English: In addition, the clinical response to treatment should be closely monitored in patients receiving Emtricitabine/Tenofovir disoproxil Zentiva at a prolonged dosing interval.
Croatian: Osim toga, klinički odgovor na liječenje treba pažljivo pratiti u bolesnika koji primaju Emtricitabine/Tenofovir disoproxil Zentiva u produljenom intervalu doziranja.
English: 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.
Croatian: Uzimanje emtricitabina/tenofovirdizoproksila s hranom rezultiralo je odgodom postizanja maksimalnih koncentracija tenofovira za približno tri četvrtine sata i porastom vrijednosti AUC i Cmax tenofovira za približno 35% odnosno 15%, kada je lijek uziman s obrokom bogatim mastima ili s laganim obrokom, u usporedbi s uzimanjem natašte.
English: Emtricitabine and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion.
Croatian: Emtricitabin i tenofovir primarno se izlučuju preko bubrega kombinacijom glomerularne filtracije i aktivne tubularne sekrecije.
English: 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.
Croatian: Te nalaze treba uzeti u obzir u svakog djeteta koje je i utero bilo izloženo analozima nukleozida i nukleotida, a koje je imalo tešku kliničku sliku nepoznate etiologije, osobito neurološke nalaze.
English: 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.
Croatian: Emtricitabin/tenofovirdizoproksil nije ispitana u osoba koje nisu zaražene virusom HIV-1 s klirensom kreatinina < 60 ml/min pa se stoga ne preporučuje njezina primjena u ovoj populaciji.
English: In vitro and clinical pharmacokinetic interaction studies have shown the potential for CYP450 mediated interactions involving emtricitabine and tenofovir disoproxil with other medicinal products is low.
Croatian: In vitro i klinička ispitivanja farmakokinetičkih interakcija pokazala su da je potencijal za interakcije emtricitabina i tenofovirdizoproksila s drugim lijekovima posredstvom CYP450 nizak.
English: Uncommon hypokalaemia1
Croatian: Manje često hipokalijemija1
English: Cmin: NC Tenofovir:
Croatian: Cmin: NI Tenofovir:
English: Film coating: polyvinyl alcohol, titanium dioxide, macrogol, talc, indigo carmine aluminum lake (E 132).
Croatian: Film ovojnica poli(vinilni) alkohol titanijev dioksid makrogol talk boja Indigo carmine aluminum lake (E 132)
English: Emtricitabine/Tenofovir disoproxil Zentiva is not always effective in preventing the acquisition of HIV-1.
Croatian: Emtricitabine/Tenofovir disoproxil Zentiva nije uvijek djelotvoran u sprječavanju dobivanja virusa HIV-1.
English: Tenofovir disoproxil 245 mg (n = 1,584)
Croatian: Tenofovirdizoproksil 245 mg (n = 1584)
English: • breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells.
Croatian: • propadanje mišića, bolovi u mišićima ili slabost mišića, koji mogu nastati zbog oštećenja stanica bubrežnih kanalića
English: Lamivudine/ zidovudine/ efavirenz
Croatian: Lamivudin/ zidovudin/ efavirenz
English: 13% of the emtricitabine dose was recovered in urine as three metabolites.
Croatian: Trinaest posto doze emtricitabina izolirano je u mokraći u obliku triju metabolita.
English: The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 ml/min; mild impairment with CrCl = 50 - 79 ml/min; moderate impairment with CrCl = 30 - 49 ml/min and severe impairment with CrCl = 10 - 29 ml/min).
Croatian: Stupanj oštećenja funkcije bubrega definiran je prema početnom klirensu kreatinina (CrCl) (normalna funkcija bubrega kada je CrCl > 80 ml/min; blago oštećenje uz CrCl = 50 - 79 ml/min; umjereno oštećenje uz CrCl = 30 - 49 ml/min i teško oštećenje uz CrCl = 10 - 29 ml/min).
English: • Genotypic resistance to efavirenz, predominantly the K103N mutation, developed in virus from 13/19 (68%) patients in the emtricitabine/tenofovir disoproxil/efavirenz group and in virus from 21/29 (72%) patients in the comparative group.
Croatian: • Genotipska rezistencija na efavirenz, pretežno mutacija K103N, razvila se kod virusa prikupljenima u 13/19 (68%) bolesnika iz skupine koja je primala emtricitabin/tenofovirdizoproksil/efavirenz te kod virusa prikupljenima u 21/29 (72%) bolesnika u usporednoj skupini.
English: The mean changes in CD4 cell count from baseline were +185 cells/mm3 and +196 cells/mm3, respectively.
Croatian: Srednja vrijednost promjene broja CD4 stanica od početne vrijednosti bila je +185 stanica/mm3 odnosno +196 stanica/mm3.
English: ANTI-INFECTIVES Antiretrovirals
Croatian: Antiretrovirusni lijekovi
English: However, individuals should be informed that dizziness has been reported during treatment with both emtricitabine and tenofovir disoproxil.
Croatian: Međutim, osobe je potrebno obavijestiti da je zabilježena omaglica tijekom liječenja i emtricitabinom i tenofovirdizoproksilom.
English: Some patients taking combination antiretroviral medicines such as Emtricitabine /Tenofovir disoproxil Zentiva may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Croatian: U nekih se bolesnika koji uzimaju kombiniranu antiretrovirusnu terapiju kao što je Emtricitabine/Tenofovir disoproxil Zentiva može razviti koštana bolest koja se naziva osteonekrozom (odumiranje koštanog tkiva uzrokovano gubitkom opskrbe kosti krvlju).
English: Repeated dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use include renal and bone toxicity and a decrease in serum phosphate concentration.
Croatian: Ispitivanja toksičnosti ponovljenih doza provedena na štakorima, psima i majmunima pri razinama izloženosti višima ili jednakima kliničkim razinama izloženosti te s mogućim značajem za kliničku upotrebu, uključuju toksičnost za bubrege i kosti i smanjenje koncentracije fosfata u serumu.
English: In HIV-1 infected adolescents (aged 12 to < 18 years), the BMD Z-scores observed in subjects who received tenofovir disoproxil were lower than those observed in subjects who received placebo.
Croatian: U adolescenata (u dobi od 12 do < 18 godina) zaraženih virusom HIV-1, z-vrijednosti BMD-a zabilježene u ispitanika koji su primali tenofovirdizoproksil bile su niže nego u ispitanika koji su dobili placebo.
English: 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 studies and the expanded access program (n = 7,319).
Croatian: Kategorija učestalosti procijenjena je statističkim izračunom na temelju ukupnog broja bolesnika izloženih emtricitabinu u randomiziranim kontroliranim kliničkim ispitivanjima (n = 1563) ili tenofovirdizoproksilu u randomiziranim kontroliranim kliničkim ispitivanjima i programu proširenog pristupa liječenju (n = 7319).