FrancophonIA/ELRC3.0 huggingface dataset:
English: These reactions are usually mild to moderate gastrointestinal events.
Croatian: Te su reakcije obično blagi do umjereni gastrointestinalni događaji.
English: Wait and take the next dose at the regular time.
Croatian: Pričekajte, pa sljedeću dozu uzmite u uobičajeno vrijeme.
English: Keep the tablet bottle with you so that you can easily describe what you have taken.
Croatian: Sa sobom ponesite bočicu s tabletama kako bi lakše opisati što ste uzeli.
English: Benefit has also been demonstrated based on histological responses in compensated patients.
Croatian: Dobrobit je također dokazana na temelju histoloških odgovora u kompenziranih bolesnika.
English: 65926 Frankfurt am Main Germany
Croatian: 65926 Frankfurt am Main Njemačka
English: Response after addition of emtricitabine is excluded (total of 17 subjects across both studies).
Croatian: Odgovor nakon dodavanja emtricitabina bio je isključen (ukupno 17 ispitanika u oba ispitivanja).
English: These symptoms may indicate that your body's improved immune system is fighting infection.
Croatian: Ti simptomi mogu ukazivati na to da se poboljšani imunološki sustav Vašega tijela bori protiv infekcije.
English: Use within 60 days after first opening.
Croatian: Upotrijebiti unutar 60 dana nakon prvog otvaranja.
English: The clinical implications of this are unknown.
Croatian: Nisu poznate kliničke implikacije toga.
English: If Tenofovir disoproxil Zentiva has been prescribed for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).
Croatian: Ako je Tenofovir disoproxil Zentiva propisan Vašem djetetu, molimo obratite pozornost da se sve informacije u ovoj uputi odnose na Vaše dijete (u tom slučaju umjesto „Vi” čitajte „Vaše dijete”).
English: • Always take the dose recommended by your doctor.
Croatian: • Uvijek uzmajte onu dozu koju Vam je preporučio liječnik.
English: • Take care not to infect other people.
Croatian: • Pazite da ne zarazite druge osobe.
English: Study 174-0108
Croatian: Ispitivanje 174-0108
English: Histology Histological response (%)b
Croatian: Histologija Histološki odgovor (%)b
English: The tablets are suitable for:
Croatian: Tablete su pogodne u:
English: • Adults: One tablet each day with food (for example, a meal or a snack).
Croatian: • Odrasli: jedna tableta svaki dan s hranom (na primjer, s obrokom ili užinom).
English: • Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Croatian: • Liječnika odmah obavijestite o novim ili neuobičajenim simptomima nakon što se prestanete liječiti, osobito o simptomima koje dovodite u vezu s infekcijom hepatitisom B.
English: Staggered administration (12 hours apart) provided similar results.
Croatian: Primjena s vremenskim odmakom (u razmaku od 12 sati) dala je slične rezultate.
English: 102 37 Prague 10
Croatian: 102 37 Prag 10
English: • adolescents aged 12 to less than 18 years.
Croatian: • adolescenata u dobi od 12 do manje od 18 godina.
English: With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Croatian: Kod produženog liječenja dužeg od 2 godine, preporučuje se redovno ponavljati preglede, kako bi se potvrdilo da je nastavak izabrane terapije i dalje prikladan za bolesnika.
English: Serology (%)
Croatian: Serologija (%)
English: Treatment discontinuation may be considered as follows:
Croatian: Prekid liječenja može se razmotriti u sljedećim slučajevima:
English: BMD Z-scores were not adjusted for height and weight.
Croatian: BMD Z-rezultat nije bio prilagođen za tjelesnu visinu i težinu.
English: However, severe exacerbations, including fatalities, have been reported.
Croatian: Međutim, zabilježene su i teške egzacerbacije, uključujući smrtne slučajeve.
English: ATC code: J05AF07.
Croatian: ATK oznaka: J05AF07
English: Data pertaining to HIV
Croatian: Podaci koji se odnose na HIV
English: Tests may also show: • decreases in phosphate in the blood.
Croatian: Pretrage također mogu pokazati: • smanjenje fosfata u krvi
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: Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine
Croatian: Vaš će liječnik pažljivo razmotriti hoće li Vas liječiti kombinacijama tenofovira i didanozina.
English: 2 years Shelf-life after first opening is 60 days.
Croatian: 2 godine Rok valjanosti nakon prvog otvaranja je 60 dana.
English: You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.
Croatian: Isto tako možete HIV ili HBV prenijeti na druge pa je zbog toga važno poduzeti mjere opreza kako biste izbjegli inficiranje drugih osoba
English: • It is very important to tell your doctor if you are taking other medicines that may damage your kidneys.
Croatian: • Vrlo je važno da obavijestite liječnika ako uzimate druge lijekove koji mogu oštetiti bubrege.
English: Tests may also show:
Croatian: Pretrage također mogu pokazati:
English: • If it is more than 12 hours since you should have taken it, forget about the missed dose.
Croatian: • Ako je proteklo više od 12 sati od vremena kada ste je trebali uzeti, zaboravite na dozu koju ste propustili.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Croatian: Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) ili rijetko ( ≥ 1/10 000 i < 1/1000).
English: If you have hepatitis B infection, your doctor will carefully consider the best treatment for you.
Croatian: Ako ste zaraženi hepatitisom B, liječnik će pažljivo razmislit o najboljem liječenju za Vas.
English: The HIV and HBV adolescent educational brochures should contain the following key messages:
Croatian: Edukacijske brošure za adolescente s HIV-om i HBV-om trebaju sadržavati sljedeće ključne poruke:
English: • deep, rapid breathing,
Croatian: • duboko, brzo disanje
English: Non-clinical safety pharmacology studies reveal no special hazard for humans.
Croatian: Neklinička ispitivanja sigurnosne farmakologije ne ukazuju na poseban rizik za ljude.
English: Therefore, hepatobiliary and renal parameters should be closely monitored in this patient population.
Croatian: Stoga se moraju pomno nadzirati hepatobilijarni i bubrežni parametri u ovoj populaciji bolesnika.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 September 2016
Croatian: Datum prvog odobrenja: 15.rujna 2016.
English: *Generally, once weekly dosing assuming three haemodialysis sessions per week, each of approximately 4 hours duration or after 12 hours cumulative haemodialysis.
Croatian: *Općenito vrijedi: doziranje jedanput na tjedan pod pretpostavkom tri hemodijalize na tjedan, svaka u trajanju od približno 4 sata ili nakon 12 sati kumulativne hemodijalize.
English: If you are an adult, your doctor may advise you to take the tablets less often.
Croatian: Ako ste odrasla osoba, liječnik će Vam možda savjetovati da rjeđe uzimate tablete.
English: Autoimmune disorders may occur many months after the start of treatment.
Croatian: Autoimuni poremećaji mogu se pojaviti više mjeseci nakon početka liječenja.
English: If this is unavoidable, your doctor will monitor your kidney function once a week.
Croatian: Ako se to ne može izbjeći, liječnik će Vam jednom tjedno pratiti funkciju bubrega.
English: No further K65R development was observed up to week 144.
Croatian: Do 144. tjedna nije zapažen nikakav daljnji razvoj K65R.
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 virusna supresija antiretrovirusnom terapijom znatno smanjuje rizik od prijenosa bolesti spolnim putem, ne može se isključiti rezidualni rizik.
English: Other suitable formulations should be checked for their availability.
Croatian: Potrebno je provjeriti dostupnost drugih prikladnih formulacija ovog lijeka.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Croatian: HIV virus možete prenijeti čak i dok uzimate ovaj lijek, iako je tada rizik od prijenosa manji zbog učinkovite antiretrovirusne terapije.
English: Week
Croatian: Tjedan
English: Post-treatment exacerbations are usually associated with rising HBV DNA, and the majority appears to be self-limited.
Croatian: Egzacerbacije nakon liječenja obično su povezane s porastom razina HBV DNK i čini se da su većina njih samoograničavajuća.
English: In addition, 61% of patients had normal ALT at week 48.
Croatian: Osim toga, 61% bolesnika imalo je normalnu razinu ALT-a u 48. tjednu.
English: These dose interval adjustments have not been confirmed in clinical studies.
Croatian: Te prilagodbe intervala između doza nisu potvrđene kliničkim ispitivanjima.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik.
English: Triple therapy with nucleosides/nucleotides
Croatian: Trojna terapija nukleozidima/nukleotidima
English: Interaction with didanosine
Croatian: Interakcija s didanozinom
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Croatian: Ako uočite bilo koje simptome infekcije ili druge simptome poput slabosti mišića, slabosti koja počinje u šakama i stopalima i pomiče se prema trupu tijela, palpitacije tremora ili hiperaktivnosti, obavijestite svog liječnika odmah kako biste potražili liječničku pomoć.
English: • If it is less than 12 hours after it is usually taken, take it as soon as you can, and then take your next dose at its regular time.
Croatian: • Ako je proteklo manje od 12 sati od vremena kada je obično uzimate, uzmite dozu čim možete, a potom sljedeću dozu uzmite u uobičajeno vrijeme.
English: Efavirenz or lamivudine resistance either preceded or was coincident with the development of K65R in all cases.
Croatian: U svim je slučajevima otpornost na efavirenz ili lamivudin prethodila ili bila istovremena s razvojem K65R.
English: • At the request of the European Medicines Agency; • 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 (pharmacovigilance or risk minimisation) milestone being reached.
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: Ethnicity Pharmacokinetics have not been specifically studied in different ethnic groups.
Croatian: Etnička pripadnost Farmakokinetika nije posebno ispitivana u skupinama različite etničke pripadnosti.
English: • HIV adolescent educational brochure • HBV adolescent educational brochure
Croatian: • Edukacijsku brošuru za adolescente s HIV-om • Edukacijsku brošuru za adolescente s HBV-om
English: The following side effects may be signs of lactic acidosis:
Croatian: Sljedeće nuspojave mogu biti znakovi laktacidoze:
English: Therefore, a multidisciplinary approach is recommended to adequately weigh on a case by case basis the benefit/risk balance of treatment, decide the appropriate monitoring during treatment (including decision for treatment withdrawal) and consider the need for supplementation.
Croatian: Stoga se preporučuje multidisciplinarni pristup kako bi se u svakom pojedinom slučaju primjereno odredio omjer koristi i rizika liječenja, odlučilo o odgovarajućem praćenju tijekom liječenja (uključujući odluku o prekidu liječenja) i razmotrila potreba za nadomještanjem.
English: Histological response a,b a The population used for analysis of histology included only patients with available liver biopsy data (Missing = Excluded) by week 240.
Croatian: Histološki odgovora,b a Populacija koja se koristila za histološku analizu uključila je samo bolesnike s dostupnim podacima za biopsiju jetre (podaci nedostaju = isključeni) do 240. tjedna.
English: Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets.
Croatian: U svakoj se boci nalazi silikagel kao sredstvo za sušenje, koje se mora držati u boci radi zaštite tableta.
English: • Talk to your doctor or pharmacist if you have had kidney disease or if tests have shown problems with your kidneys.
Croatian: • Obavijestite liječnika ili ljekarnika ako ste imali bolest bubrega ili ako su testovi pretrage ukazivali na probleme s bubrezima.
English: Tenofovir is also active against HIV-1 subtypes A, C, D, E, F, G, and O and against HIVBaL in primary monocyte/macrophage cells.
Croatian: Tenofovir također djeluje na HIV-1 podtipove A, C, D, E, F, G, i O te na HIVBaL u primarnim stanicama monocita/makrofaga.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1127/001 30 film-coated tablets EU/1/16/1127/002 90 (3x30) film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1127/001 30 filmom obloženih tableta EU/1/16/1127/002 90 (3x30) filmom obloženih tableta
English: • If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of your antiretroviral therapy to you and your child.
Croatian: • Ako zatrudnite ili planirate trudnoću, obratite se liječniku kojiće vam objasniti koje su moguće koristi i rizici antiretrovirusne terapije za Vas i Vaše dijete.
English: All adverse reactions are presented in Table 2.
Croatian: Sve su nuspojave prikazane u Tablici 2.
English: Table 7: Safety and efficacy parameters in decompensated patients at week 48
Croatian: Tablica 7: Parametri sigurnosti i djelotvornosti u dekompenziranih bolesnika u 48. tjednu
English: Do not reduce the prescribed dose, unless your doctor has told you to do so.
Croatian: Nemojte snižavati propisanu dozu, osim ako Vam je tako rekao liječnik.
English: However, a benefit is expected for the adolescent population based on extrapolation of adult data and comparative pharmacokinetic data (see section 5.2).
Croatian: Međutim, korist se očekuje u adolescentskoj populaciji na temelju ekstrapolacije rezultata za odrasle i usporedivih farmakokinetičkih podataka (vidjeti dio 5.2).
English: Decreases in BMD of hip were significantly greater in this group until 96 weeks.
Croatian: Smanjenja BMD-a kuka bila su 96. tjedna značajno veća u toj skupini.
English: • If you have taken 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 lijek Tenofovir disoproxil Zentiva tijekom trudnoće, postoji mogućnost da liječnik zatraži redovito provođenje krvnih i drugih dijagnostičkih pretraga kako bi pratio razvoj Vašeg djeteta.
English: • Recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment
Croatian: • Preporučeni raspored praćenja funkcije bubrega s obzirom na prisutnost ili odsutnost dodatnih čimbenika rizika za oštećenje funkcije bubrega.
English: Duration of therapy in adult and adolescent patients with chronic hepatitis B
Croatian: Trajanje liječenja u odraslih i adolescentnih bolesnika s kroničnim hepatitisom B
English: Week 192
Croatian: 192. tjedan
English: • increased creatinine in your blood,
Croatian: • povišenu razinu kreatinina u krvi
English: • Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day with food (for example, a meal or a snack).
Croatian: • Adolescenti u dobi od 12 do manje od 18 godina tjelesne težine od najmanje 35 kg: jedna tableta svaki dan s hranom (na primjer, s obrokom ili užinom).
English: Entecavir (0.5 mg or 1 mg) n = 22
Croatian: Entekavir (0,5 mg ili 1 mg) n = 22
English: • You must not take Tenofovir disoproxil Zentiva during pregnancy unless specifically discussed with your doctor.
Croatian: • Tenofovir disoproxil Zentiva ne smijete uzimati tijekom trudnoće, osim ako o tome niste izričito razgovarali s liječnikom.
English: The silica gel desiccant is contained in a separate container and should not be swallowed.
Croatian: Silikagel se nalazi u posebnom spremniku i ne smije se progutati.
English: Data pertaining to HBV
Croatian: Podaci koji se odnose na HBV
English: Magnesium stearate
Croatian: magnezijev stearat.
English: Co-administration and risk of renal toxicity The same recommendations apply as in adults (see above).
Croatian: Istovremena primjena i rizik od bubrežne toksičnosti Vrijede iste preporuke kao i za odrasle (vidjeti gore).
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 poboljšanim zdravljem i stilom života, dok je u slučaju lipida u krvi katkad povezano i sa samim lijekovima za liječenje HIV-a.
English: Interactions between tenofovir disoproxil and other medicinal products are listed in Table 1 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 tenofovirdizoproksila i drugih lijekova navedene su u sljedećoj Tablici 1 (povećanje je označeno kao „↑”, smanjenje kao „↓”, bez promjene kao „↔”, dvaput na dan kao „b.i.d.“ i jedanput na dan kao „q.d.“).
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Croatian: U djece čije su majke tijekom trudnoće uzimale NRTI-je prevagnula je korist od zaštite protiv HIV-a u odnosu na rizike od nuspojava.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see sections 4.8 and 5.3), and standard supportive treatment applied as necessary.
Croatian: U slučaju predoziranja bolesnik mora biti pod nadzorom zbog znakova toksičnosti (vidjeti dio 4.8 i 5.3) te mu se, prema potrebi, mora pružiti standardno potporno liječenje.
English: Renal function (creatinine clearance and serum phosphate) should be evaluated prior to treatment, and monitored during treatment as in adults (see above).
Croatian: Funkciju bubrega (klirens kreatinina i fosfat u serumu) treba procijeniti prije početka liječenja i pratiti tijekom liječenja kao u odraslih (vidjeti gore).
English: If appropriate, resumption of hepatitis B therapy may be warranted.
Croatian: Ako je to prikladno, nastavak terapije za hepatitis B može biti opravdan.
English: increased transaminases
Croatian: povišene transaminaze
English: The majority of subjects were either genotypes C (43.8%) or D (41.6%) with a lower and similar frequency of genotypes A and B (6.7% each).
Croatian: Većina je ispitanika bila genotipa C (43,8%) ili D (41,6%) uz manju i sličnu učestalost genotipova A i B (6,7% svaki).
English: Complete response (%)a
Croatian: Potpuni odgovor (%)a
English: Excipient with known effect: Each tablet contains 214.5 mg lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 214,5 mg laktoze hidrata.
English: Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.
Croatian: Bolesnici s bolešću jetre, uključujući kronični hepatitis B ili C, koji se liječe antiretrovirusnim lijekovima, izloženi su većem riziku od teških i potencijalno fatalnih jetrenih komplikacija.
English: No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 4.4).
Croatian: Ne postoje podaci na osnovi kojih bi se mogla preporučiti doza za bolesnike starije od 65 godina (vidjeti dio 4.4).
English: The decision to treat paediatric patients (adolescents) should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information.
Croatian: Odluka o liječenju pedijatrijskih bolesnika (adolescenata) treba se temeljiti na pažljivom razmatranju potreba pojedinog bolesnika te se trebaju uzeti u obzir trenutne smjernice za liječenje pedijatrijskih bolesnika, uključujući početnu vrijednost histoloških značajki.
English: Reproductive 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 iili fetalne parametre.
English: At concentrations of up to 300 µmol/l, tenofovir has also shown no effect on the synthesis of mitochondrial DNA or the production of lactic acid in in vitro assays.
Croatian: U koncentracijama do 300 µmol/l tenofovir nije pokazao učinak na sintezu mitohondrijske DNK ili na stvaranje mliječne kiseline u in vitro analizama.
English: With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.
Croatian: U pogledu odluke o uvođenju liječenja u pedijatrijskih bolesnika, vidjeti dijelove 4.2, 4.4, 4.8 i 5.1.
English: At weeks 96, 144, 192, 240, 288 and 384, viral suppression, biochemical and serological responses were maintained with continued tenofovir disoproxil treatment (see Tables 4 and 5 below).
Croatian: U 96., 144., 192., 240., 288. i 384. tjednu supresija virusa, i biokemijski i serološki odgovori bili su održani uz nastavak liječenja tenofovirdizoproksilom (vidjeti Tablice 4 i 5 niže).
English: U Kabelovny 130 102 37 Prague 10 Czech Republic
Croatian: U Kabelovny 130 102 37 Prag 10
English: Tests may also show: • liver problems.
Croatian: Pretrage također mogu pokazati: • tegobe s jetrom
English: Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Croatian: Jetrenu funkciju treba pratiti u ponovljenim intervalima s kliničkim i laboratorijskim kontrolama najmanje šest mjeseci nakon prekida terapije hepatitisa B.
English: Tenofovir can be removed by haemodialysis; the median haemodialysis clearance of tenofovir is 134 ml/min.
Croatian: Tenofovir se može ukloniti hemodijalizom; medijan klirensa tenofovira hemodijalizom jest 134 ml/min.
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with tenofovir disoproxil.
Croatian: Opsežni podaci (više od 1000 trudnoća) ne ukazuju na postojanje malformacija ili feto/neonatalno toksičnog učinka povezanog s tenofovirdizoproksilom.
English: Following oral administration the terminal half-life of tenofovir is approximately 12 to 18 hours.
Croatian: Nakon peroralne primjene, terminalni poluvijek eliminacije tenofovira iznosi približno 12 - 18 sati.
English: The following pack sizes are available: Outer cartons containing 1 bottle of 30 film-coated tablets and 3 bottles of 30 film-coated tablets.
Croatian: Dostupne su sljedeće veličine pakiranja: Kutije koje sadrže 1 bocu s 30 filmom obloženih tableta i 3 boce s 30 filmom obloženih tableta.
English: • If you have HBV your doctor may offer you an HIV test to see if you have both HBV and HIV.
Croatian: • Ako ste inficirani HBV-om, Vaš liječnik Vas može uputiti na testiranje infekcije HIV-om kako bi se utvrdilo jeste li istodobno zaraženi i HBV-om i HIV-om.