FrancophonIA/ELRC3.0 huggingface dataset:
English: • Reminder on the importance of strict adherence to the recommended dosing regimen
Croatian: • posjetnik o važnosti strogog pridržavanja preporučenog režima doziranja
English: The 144 week secondary endpoint data are also presented in Table 4.
Croatian: 4. Podaci sekundarne mjere ishoda nakon 144 tjedna također su prikazani u Tablici 4.
English: However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Croatian: No kao što se u toj populaciji pacijenata moglo očekivati, porast vrijednosti AST i ALT bio je češći nego u općoj populaciji zaraženoj HIV-om.
English: • Provides information on the possible side effects
Croatian: • pruža informacije o mogućim nuspojavama
English: Antiviral activity in vitro
Croatian: Antivirusno djelovanje in vitro
English: Whether such neurological disorders are transient or permanent is currently unknown.
Croatian: Trenutno nije poznato jesu li takvi neurološki poremećaji prolazni ili trajni.
English: It is thought that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Croatian: Smatra se da ti simptomi nastaju zbog poboljšanja imunološkog odgovora organizma, zbog čega je tijelo sposobno boriti se protiv infekcija koje mogu biti prisutne bez vidljivih simptoma.
English: Decreases in BMD of hip were significantly greater in this group until 96 weeks.
Croatian: Smanjenja BMD-a kuka bila su do 96. tjedna značajno veća u toj skupini.
English: In general, the pharmacokinetics of emtricitabine in infants, children and adolescents (aged 4 months up to 18 years) are similar to those seen in adults.
Croatian: Općenito, farmakokinetika emtricitabina u dojenčadi, djece i adolescenata (u dobi od 4 mjeseca do 18 godina) slična je onoj opaženoj u odraslih osoba.
English: Number with Tenofovir Detected/ Total Samples (%)
Croatian: Broj uzoraka s detektiranim tenofovirom / ukupni broj uzoraka (%)
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin with 90% confidence intervals if available (mechanism)
Croatian: Učinci na razinu lijekova Postotak prosječne promjene za AUC, Cmax, Cmin uz 90% intervale pouzdanosti ukoliko su dostupni (mehanizam)
English: Concomitant use not recommended
Croatian: Istovremena primjena koja se ne preporučuje
English: You must get tested to make sure that you do not already have HIV infection.
Croatian: Morate se testirati kako biste potvrdili da nemate HIV infekciju.
English: Do not take this medicine to reduce your risk unless you are confirmed to be HIV negative.
Croatian: Nemojte uzimati ovaj lijek da biste smanjili svoj rizik osim ako je potvrđeno da ste HIV negativni.
English: • interleukin-2 (to treat cancer)
Croatian: • interleukin-2 (za liječenje raka)
English: Each tablet contains 93.6 mg lactose monohydrate.
Croatian: Jedna tableta sadržava 93,6 mg laktoze hidrata.
English: The frequency of the following side effects is not known.
Croatian: Učestalost sljedećih nuspojava nije poznata.
English:  If you think you may have lactic acidosis, get medical help immediately.
Croatian: Ako mislite da možda imate laktacidozu, odmah potražite liječničku pomoć.
English: Immune Reactivation Syndrome
Croatian: Sindrom imunološke reaktivacije
English: • softening of the bones (with bone pain and sometimes resulting in fractures)
Croatian: • omekšavanje kostiju (uz bol u kostima i ponekad s posljedičnim prijelomima)
English: hepatic steatosis, hepatitis
Croatian: jetrena steatoza, hepatitis
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Croatian: Iako je dokazano da učinkovita supresija virusa antiretrovirusnom terapijom znatno smanjuje rizik od prijenosa spolnim putem, ne može se isključiti rezidualni rizik.
English: • No virus analysed contained the K65R or K70E mutation.
Croatian: • Nijedan analizirani virus nije sadržavao mutaciju K65R ili K70E.
English: 41 (4 to 79)
Croatian: 41 (4 do 79)
English: They may want to do more tests to make sure you are still HIV negative.
Croatian: Liječnik će možda htjeti provesti dodatne testove kako bi potvrdio da ste i dalje HIV-negativni.
English:  If you notice these or any symptoms of inflammation or infection, get medical help immediately.
Croatian: Ako primijetite ove simptome ili bilo koji simptom upale ili infekcije, odmah potražite liječničku pomoć.
English: URAI = unprotected receptive anal intercourse
Croatian: URAI (engl. unprotected receptive anal intercourse) = nezaštićeni receptivni analni spolni odnos
English: Signs of osteonecrosis are:
Croatian: Znakovi osteonekroze su:
English: Difference (95%CI)
Croatian: Razlika (95%CI)
English: insomnia, abnormal dreams
Croatian: nesanica, abnormalni snovi
English: Limited clinical study data suggest that the prolonged dose interval is not optimal and could result in increased toxicity and possibly inadequate response.
Croatian: Ograničeni podaci iz kliničkih ispitivanja ukazuju na to da produljeni interval doziranja nije optimalan i da može rezultirati povećanom toksičnošću i mogućim neadekvatnim odgovorom.
English: • anaemia (low red blood cell count)
Croatian: • anemija (nizak broj crvenih krvnih stanica)
English: • Although there are limited clinical data on the use of emtricitabine/Tenofovir disoproxil in pregnant women, it is not usually used unless absolutely necessary.
Croatian: • Iako postoje ograničeni klinički podaci o uporabi emtricitabin/tenofovirdizoproksil u trudnica, lijek se obično ne primjenjuje osim ako to nije apsolutno potrebno.
English: Married to study partner Years living with study partner
Croatian: U braku s partnerom u ispitivanju
English: If appropriate, resumption of hepatitis B therapy may be warranted.
Croatian: Ako je prikladno, nastavak terapije hepatitisa B može biti opravdan.
English: Not recommended because appropriate dose reductions cannot be achieved with the combination tablet.
Croatian: Ne preporučuje se jer se kombiniranom tabletom ne mogu postići prikladna smanjenja doze.
English: Discuss with your doctor the precautions needed to avoid infecting other people.
Croatian: Razgovarajte sa svojim liječnikom o mjerama opreza koje morate poduzeti kako ne biste zarazili druge osobe.
English: If available, 90% confidence intervals are shown in parentheses.
Croatian: U zagradama su prikazani 90%-tni intervali pouzdanosti, ako su dostupni.
English: Use for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status.
Croatian: Primjena za predekspozicijsku profilaksu u osoba s nepoznatim ili pozitivnim HIV-1 statusom.
English: Possible serious side effects:
Croatian: Moguće ozbiljne nuspojave:
English: The same recommendations apply as in adults (see Co-administration of other medicinal products below).
Croatian: Vrijede iste preporuke kao za odrasle (vidjeti dio Istovremena primjena drugih lijekova, u nastavku).
English: Tell your doctor if you have had kidney disease, or if tests have shown kidney problems.
Croatian: Obavijestite liječnika ako ste imali bolest bubrega ili ako su pretrage pokazale tegobe s bubrezima.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kartonskoj kutiji iza „EXP”.
English: • Do not share or re-use needles or other injection or drug equipment.
Croatian: • Nemojte s drugima dijeliti ili koristiti već upotrijebljene igle ili drugi pribor za injekcije ili ubrizgavanje droge.
English: See section 2 for a list of precautions to take against HIV infection.
Croatian: Pogledajte dio 2 za popis mjera opreza koje treba poduzeti za zaštitu od HIV-infekcije.
English: • Do not share personal items that can have blood or body fluids on them, such as toothbrushes and razor blades.
Croatian: • Nemojte s drugima dijeliti osobne predmete na kojima može biti krvi ili tjelesnih tekućina, kao što su četkice za zube i britvice za brijanje.
English: Lipid disorders should be managed as clinically appropriate.
Croatian: Poremećaje lipida potrebno je liječiti na klinički odgovarajući način.
English: Gender, N (%) Male
Croatian: Spol, N (%)
English: Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations.
Croatian: Farmakoterapijska skupina: Antivirusni lijek za sistemsku primjenu; antivirusni lijekovi za liječenje infekcije HIV-om, kombinacije.
English: • Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect.
Croatian: • Laktacidoza (prekomjerna količina mliječne kiseline u krvi) je rijetka ali životno ugrožavajuća nuspojava.
English: However, a benefit is expected for the adolescent population based on extrapolation of adult data and comparative pharmacokinetic data (see section
Croatian: Međutim, korist za adolescentsku populaciju očekuje se na temelju ekstrapolacije podataka za odrasle i usporednih farmakokinetičkih podataka (vidjeti dio 5.2).
English: Age (Yrs), Median (Q1, Q3)
Croatian: Dob (godine), medijan (Q1, Q3).
English: Then mix the powder with about 100 mL (half a glass) of water, orange juice or grape juice and drink immediately.
Croatian: Prašak onda pomiješajte s oko 100 ml (pola čaše) vode, soka od naranče ili soka od grožđa, pa odmah popijte.
English: If overdose occurs the individual must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
Croatian: U slučaju predoziranja osoba mora biti pod praćenjem zbog znakova toksičnosti (vidjeti dio 4.8) te mu se, prema potrebi, mora pružiti standardno potporno liječenje.
English: Lactic acidosis occurs more often in women, particularly if they are overweight, and in people with liver disease.
Croatian: Laktacidoza češće nastaje u žena, osobito ako imaju prekomjernu tjelesnu težinu, i u osoba s bolešću jetre.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Pacijenti s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: • If you think you were infected with HIV, tell your doctor straight away.
Croatian: • Ako mislite da ste bili zaraženi HIV-om, odmah obavijestite liječnika.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet
English: Please refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.
Croatian: Molimo da pročitate upute o lijeku drugih antiretrovirusnih lijekova radi smjernica o načinu uzimanja tih lijekova.
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: This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment.
Croatian: To je iz razloga da budete sigurni da je lijek koji uzimate potpuno djelotvoran te da smanjite rizik od razvoja otpornosti na liječenje.
English: As a general rule, it is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV to the infant.
Croatian: Kao opće pravilo, preporučuje se da žene zaražene HIV-om ni pod kojim okolnostima ne doje svoju dojenčad, kako bi se izbjegao prijenos virusa HIV-a na dojenče.
English: • low white blood cell count (a reduced white blood cell count can make you more prone to infection)
Croatian: • nizak broj bijelih krvnih stanica (zbog smanjenog broja bijelih krvnih stanica možete postati skloniji infekcijama)
English: People who are HIV positive can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Croatian: Osobe koje su HIV-pozitivne i dalje mogu prenijeti HIV drugima dok uzimaju ovaj lijek, iako učinkovita antiretrovirusna terapija smanjuje taj rizik.
English: This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Croatian: To je djelomično povezano s poboljšanjem zdravstvenog stanja i stila života, a u slučaju lipida u krvi ponekad sa samim lijekovima protiv HIV-a.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Svaki upalni simptom treba procijeniti i, kada je to potrebno, uvesti liječenje.
English: elevated serum aspartate aminotransferase (AST) and/or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia increased transaminases
Croatian: povišena aspartat aminotransferaza (AST) u serumu i/ili povišena alanin aminotransferaza (ALT) u serumu, hiperbilirubinemija povišene transaminaze
English:  If you notice any of these symptoms tell your doctor.
Croatian:  Ako primijetite bilo koji od ovih simptoma, obratite se liječniku.
English: Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease.
Croatian: Dugotrajno uzimanje ove vrste lijeka, uzimanje kortikosteroida, konzumiranje alkohola, jako oslabljen imunološki sustav i prekomjerna tjelesna težina mogu biti neki od mnogobrojnih čimbenika rizika za razvoj ove bolesti.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Emtricitabine: Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.
Croatian: Neklinički podaci o emtricitabinu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: Precautions to prevent transmission of HIV by infected individuals should be taken in accordance with national guidelines.
Croatian: Potrebno je primijeniti mjere opreza za sprječavanje prijenosa HIV-a od strane zaraženih osoba u skladu s nacionalnim smjernicama.
English: Key Couple Characteristics, N (%) or Median (Q1, Q3)
Croatian: Ključne značajke para, N (%) ili medijan (Q1, Q3)
English: Limited data from clinical studies support once daily dosing (see section 4.4).
Croatian: Ograničeni podaci iz kliničkih ispitivanja govore u prilog doziranju jedanput na dan (vidjeti dio 4.4).
English: Table 1: Dosing recommendations in adults with renal impairment
Croatian: Tablica 1: Preporuke za doziranje u odraslih osoba s oštećenjem funkcije bubrega
English: GS-01-934 Treatment for 144 weeks
Croatian: GS-01-934 Liječenje u trajanju od 144 tjedna
English: The following may be signs of lactic acidosis:
Croatian: Sljedeći simptomi mogu biti znakovi laktacidoze:
English: Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Croatian: Ispitivanja reproduktivne toksičnosti u štakora i kunića nisu pokazala učinke na parenje, plodnost, trudnoću ili fetalne parametre.
English: The HIV paediatric renal educational brochure should contain the following key messages:
Croatian: Edukacijska brošura o HIV-u i renalnoj funkciji u djece treba sadržavati sljedeće ključne poruke:
English: Mitochondrial dysfunction following exposure in utero
Croatian: Poremećaj funkcije mitohondrija nakon izloženosti in utero
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Croatian: Ti nalazi ne utječu na trenutno važeće nacionalne preporuke za primjenu antiretrovirusne terapije u trudnica u cilju sprječavanja vertikalnog prijenosa HIV-a.
English: • rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches
Croatian: • osipi (uključujući crvene točkice ili mrlje, katkada s pojavom mjehurića i oticanjem kože), koji mogu biti alergijske reakcije, svrbež, promjene boje kože, uključujući tamnjenje dijelova kože
English: In individuals without risk factors for renal disease, it is recommended that renal function (creatinine clearance and serum phosphate) is monitored after two to four weeks of use, after three months of use and every three to six months thereafter.
Croatian: U osoba bez čimbenika rizika za bolest bubrega, preporučuje se pratiti funkciju bubrega (klirens kreatinina i fosfati u serumu) nakon dva do četiri tjedna primjene, nakon tri mjeseca primjene te nakon toga svakih tri do šest mjeseci.
English: • It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at least 35 kg, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects.
Croatian: • Također se primjenjuje za liječenje HIV-a u adolescenata u dobi od 12 do navršenih 18 godina koji imaju najmanje 35 kg te su već liječeni drugim lijekovima za HIV koji više nisu učinkoviti ili su izazvali nuspojave.
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Croatian: 3 Ispitivanje provedeno s dodatnom dozom voksilaprevira od 100 mg kako bi se dosegle izloženosti voksilapreviru očekivane u bolesnika zaraženih HCV-om.
English: Taking Emtricitabine/Tenofovir disoproxil Mylan with other medicines that can damage your kidneys: it is especially important to tell your doctor if you are taking any of these medicines, including
Croatian: Uzimanje lijeka Emtricitabin/tenofovirdizoproksil Mylan s drugim lijekovima koji Vam mogu oštetiti bubrege: posebno je važno da liječnika obavijestite ako uzimate neki od tih lijekova, koji uključuju:
English: • changes to your urine Rare side effects
Croatian: • promjene mokraće Rijetke nuspojave
English: Pre-exposure prophylaxis (PrEP):
Croatian: Predekspozicijska profilaksa (PrEP):
English: Elderly: No dose adjustment is required (see section 5.2).
Croatian: Starije osobe: Nije potrebno prilagođavati dozu (vidjeti dio 5.2).
English: 4.6 Fertility, pregnancy and lactation Pregnancy
Croatian: 4.6 Plodnost, trudnoća i dojenje
English: GS-01-934 Treatment for 48 weeks
Croatian: GS-01-934 Liječenje u trajanju od 48 tjedana
English: The film-coated tablet can be disintegrated in approximately 100 mL of water, orange juice or grape juice and taken immediately.
Croatian: Filmom obložena tableta može se smrviti u približno 100 ml vode, soka od naranče ili soka od grožđa i odmah uzeti.
English: 2 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Croatian: 2 Anemija je bila česta, a promjena boje kože (povećana pigmentacija) vrlo česta kad se emtricitabin primjenjivao u pedijatrijskih pacijenata.
English: Both emtricitabine and tenofovir have activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus.
Croatian: I emtricitabin i tenofovir imaju aktivnost koja je specifična za humani virus imunodeficijencije (HIV-1 i HIV-2) i virus hepatitisa B.
English: Mylan Hungary Kft Mylan utca 1, Komárom, 2900, Hungary
Croatian: Mylan Hungary Kft Mylan utca 1, Komárom, 2900, Mađarska
English: • other allergic reactions, such as wheezing, swelling or feeling light-headed
Croatian: • druge alergijske reakcije, kao što su piskanje pri disanju, oticanje ili osjećaj omaglice
English: It is important not to stop taking emtricitabine/tenofovir disoproxil without talking to your doctor: see section 3, Do not stop taking
Croatian: Važno je da ne prestanete uzimati emtricitabin/tenofovirdizoproksil bez prethodnog razgovora s liječnikom; pogledajte dio 3, Nemojte prestati uzmati lijek
English: Do not store above 25˚C, store in the original container in order to protect from moisture.
Croatian: Ne čuvati na temperaturi iznad 25°C, čuvati u originalnom pakiranju radi zaštite od vlage.
English: Studies with emtricitabine
Croatian: Ispitivanja s emtricitabinom
English: • Recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment
Croatian: • Preporučuje se raspored praćenja funkcije bubrega s obzirom na prisutnost ili odsutnost dodatnih čimbenika rizika za oštećenje bubrega.
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, molimo da također pročitate važeći sažetak opisa svojstava lijeka za te lijekove.
English: • Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines to treat HIV infection.
Croatian: • Autoimuni poremećaji, kod kojih imunološki sustav napada zdravo tkivo u organizmu, također se mogu pojaviti nakon što počnete uzimati lijekove za liječenje infekcije virusom HIV-a.
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures)1,3, myopathy1
Croatian: osteomalacija (koja se očituje bolovima u kostima i rijetko pridonosi prijelomima)1,3, miopatija1
English: Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products are listed in Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.” and once daily as “q.d.”).
Croatian: Interakcije između emtricitabin/tenofovirdizoproksila ili njegovih pojedinačnih komponenti i drugih lijekova navedene su u sljedećoj Tablici 2 (povećanje je označeno kao „↑”, smanjenje kao „↓”, bez promjene kao „↔”, dvaput na dan kao „b.i.d.” i jedanput na dan kao „q.d.”).
English: Following intravenous administration, the volume of distribution of emtricitabine and tenofovir was approximately 1.4 L/kg and 800 mL/kg, respectively.
Croatian: Nakon intravenske primjene volumen distribucije emtricitabina i tenofovira bio je približno 1,4 l/kg odnosno 800 ml/kg.
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced (BMD) (rats and dogs).
Croatian: Toksičnost za kosti dijagnosticirana je kao osteomalacija (kod majmuna) i sniženi BMD (kod štakora i pasa).
English: • problems with digestion resulting in discomfort after meals, feeling bloated, flatulence
Croatian: • problemi s probavom koji dovode do nelagode nakon obroka, osjećaj napuhnutosti, flatulencija
English: These infections make it easier for HIV to infect you.
Croatian: Te infekcije olakšavaju dobivanje infekcije HIV-om.
English: Clinical data
Croatian: Klinički podaci
English: Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Croatian: Nakon peroralne primjene, poluvrijeme eliminacije tenofovira iznosi približno 12 do 18 sati.