FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have particular difficulty swallowing, you can use the tip of a spoon to crush the tablet.
Croatian: Ako imate posebnih poteškoća s gutanjem, tabletu možete smrviti vrhom žlice.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Tenofovir disoproxil Zentiva in adolescent patients are provided with a physician educational pack containing the Summary of Product Characteristics and an appropriate educational brochure, as detailed below:
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet osigurati će da svi liječnici za koje se očekuje da će propisivati/primjenjivati lijek Tenofovir disoproxil Zentiva adolescentnim bolesnicima dobiju edukacijski paket za liječnike, koji će sadržavati sažetak opisa svojstava lijeka i odgovarajuću edukacijsku brošuru, kako je opisano niže:
English: These renal transport proteins may be responsible for tubular secretion and in part, renal elimination of tenofovir and cidofovir.
Croatian: Ti bubrežni transportni proteini mogu biti odgovorni za tubularnu sekreciju i djelomično za bubrežnu eliminaciju tenofovira i cidofovira.
English: If you have a history of liver disease or chronic hepatitis B infection your doctor may conduct blood tests to monitor your liver function.
Croatian: Ako ste imali bolest jetre ili infekciju kroničnog hepatitisa B, liječnik će možda provesti krvne pretrage kako bi mogao pomno pratiti funkciju jetre.
English: Tenofovir disoproxil Zentiva with food and drink Take Tenofovir disoproxil Zentiva with food (for example, a meal or a snack).
Croatian: Tenofovir disoproxil Zentiva s hranom i pićem Uzimajte Tenofovir disoproxil Zentiva s hranom (na primjer, uz obrok ili užinu).
English: From both the genotypic and phenotypic analyses there was no evidence for other pathways of resistance to tenofovir.
Croatian: Ni genotipske ni fenotipske analize nisu pružile dokaze drugih putova razvoja rezistencije na tenofovir.
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Tenofovir disoproxil Zentiva.
Croatian: Neki su bolesnici imali krvne pretrage ili simptome koji su ukazivali na to da im se hepatitis pogoršao nakon prestanka liječenja lijekom Tenofovir disoproxil Zentiva.
English: This active substance is an antiretroviral or antiviral medicine which is used to treat HIV or HBV infection or both.
Croatian: Ta djelatna tvar je antiretrovirusni odnosno antivirusni lijek koji se primjenjuje za liječenje HIV-ili HBV-infekcije ili oboje.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Croatian: Zabilježeni su slučajevi osteonekroze, osobito u bolesnika s općepoznatim čimbenicima rizika, uznapredovalom HIV bolešću ili dugotrajnom izloženošću CART-u.
English: Subjects with a high baseline CPT score were at higher risk of developing serious adverse events (see section 4.4).
Croatian: Ispitanici s visokim početnim CPT rezultatom imali su veći rizik od razvoja ozbiljnih nuspojava(vidjeti dio 4.4).
English: Stopping treatment with Tenofovir disoproxil Zentiva may reduce the effectiveness of the treatment recommended by your doctor.
Croatian: Prestanak liječenja lijekom Tenofovir disoproxil Zentiva može smanjiti učinkovitost terapije koju Vam je preporučio liječnik.
English: Simulations suggest that the prolonged dose interval using Tenofovir disoproxil Zentiva 245 mg film-coated tablets is not optimal and could result in increased toxicity and possibly inadequate response.
Croatian: Simulacije navode na zaključak da produženi interval između doza Tenofovir disoproxil Zentiva 245 mg filmom obloženih tableta nije optimalan i može dovesti do povećane toksičnosti i eventualno do neadekvatnog odgovora.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Croatian: Iako se smatra da je etiologija multifaktorska (uključujući primjenu kortikosteroida, konzumaciju alkohola, tešku imunosupresiju, veći indeks tjelesne mase), zabilježeni su slučajevi osteonekroze osobito u bolesnika s uznapredovalom HIV-bolešću i/ili dugotrajnom izloženošću CART-u.
English: Refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.
Croatian: Pročitajte upute o lijeku drugih antiretrovirusnih lijekova, u kojima se nalaze smjernice o načinu uzimanja tih lijekova.
English: • Other medicines containing didanosine (for HIV infection): Taking Tenofovir disoproxil Zentiva with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Croatian: • Drugi lijekovi koji sadrže didanozin (za infekciju virusom HIV-a): Uzimanjem lijeka Tenofovir disoproxil Zentiva s drugim antivirusnim lijekovima koji sadrže didanozin može se povećati razina didanozina u krvi i smanjiti broj CD4 stanica.
English: Treatment discontinuation may also be considered after stable virological suppression is achieved (i.e. for at least 3 years) provided serum ALT and HBV DNA levels are followed regularly after treatment discontinuation to detect any late virological relapse.
Croatian: Prekid liječenja također se može razmotriti nakon što je postignuta stabilna virusna supresija (tj. najmanje 3 godine) pod uvjetom da se razine serumskog ALT-a i HBV DNK redovito prate nakon prekida liječenja kako bi se uočio svaki kasni virološki relaps.
English: Renal and bone effects in adult population
Croatian: Učinci na bubrege i kosti u odrasloj populaciji
English: • Talk to your doctor before you stop taking Tenofovir disoproxil Zentiva for any reason, particularly if you are experiencing any side effects or you have another illness.
Croatian: • Razgovarajte s liječnikom prije nego što iz bilo kojeg razloga prestanete uzimati lijek Tenofovir disoproxil Zentiva, osobito ako primijetite neke nuspojave ili dobijete neku drugu bolest.
English: Week 72
Croatian: 72. tjedan
English: Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic hepatitis B.
Croatian: Terapiju mora započeti liječnik s iskustvom u liječenju infekcije HIV-om i/ili u liječenju kroničnog hepatitisa B.
English: Age Pharmacokinetic studies have not been performed in the elderly (over 65 years of age).
Croatian: Dob Nisu provedena farmakokinetička ispitivanja u starijih osoba (starijih od 65 godina).
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Croatian: Znakovi osteonekroze su ukočenost zglobova, bolovi (osobito u kuku, koljenu i ramenu) te otežano kretanje.
English: If you notice any of these symptoms tell your doctor.
Croatian: Ako opazite primijetite bilo koji od tih simptoma, obavijestite liječnika.
English: If you notice signs of inflammation or infection, tell your doctor at once.
Croatian: Ako opazite znakove upale ili infekcije, odmah o tome obavijestite liječnika.
English: Overall, the data derived from this study are too limited to draw any definitive conclusions on the comparison of emtricitabine plus tenofovir disoproxil versus tenofovir disoproxil, (see Table 7 below).
Croatian: Ukupno gledano, podaci dobiveni iz ovog ispitivanja previše su ograničeni da bi se iz njih mogao izvući konačni zaključak o usporedbi emtricitabina u kombinaciji s tenofovirdizoproksilom nasuprot tenofovirdizoproksila (vidjeti Tablicu 7 niže).
English: As a general rule, it is recommended that HIV and HBV infected women do not breast-feed their infants in order to avoid transmission of HIV and HBV to the infant.
Croatian: Kao opće pravilo, preporučuje se da žene inficirane HIV-om i HBV-om ne doje svoju dojenčad, kako bi se izbjegao prijenos HIV-a ili prijenos HBV-a na dojenče.
English: The following side effects are uncommon (may affect up to 1 in 100 people): • breakdown of muscle, muscle pain or weakness.
Croatian: Sljedeće nuspojave su manje česte (mogu se javiti u do 1 na 100 osoba): • oštećenje mišića, bol ili slabost u mišićima
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (BMD) (rats and dogs).
Croatian: Toksičnost za kosti dijagnosticirana je kao osteomalacija (kod majmuna) i snižena mineralna gustoća kostiju (BMD) (kod štakora i pasa).
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactataemia, hyperlipasaemia).
Croatian: Glavne zabilježene nuspojave su hematološki poremećaji (anemija, neutropenija) i metabolički poremećaji (hiperlaktatemija, hiperlipazemija).
English: Although there are limited clinical data on the use of Tenofovir disoproxil Zentiva in pregnant women, it is not usually used unless absolutely necessary.
Croatian: Nema dovoljno kliničkih podataka o prmjeni lijeka Tenofovir disoproxil Zentiva u trudnica pa se on obično ne koristi osim ako to nije apsolutno potrebno.
English: k One patient in this group became HBsAg negative for the first time at the 240 week visit and was ongoing in the study at the time of the data cut-off.
Croatian: k Jedan bolesnik u ovoj skupini postao je HBsAg negativan prvi put na kontrolnom pregledu u 240.
English: The safety and efficacy of tenofovir disoproxil in HIV-1 infected children or children with chronic hepatitis B under 2 years of age have not been established.
Croatian: Sigurnost i djelotvornost tenofovirdizoproksila u djece s infekcijom virusom HIV-1 ili djece s kroničnim hepatitisom B mlađe od 2 godine nisu ustanovljene.
English: Tenofovir diphosphate is a weak inhibitor of cellular polymerases α, β, and γ.
Croatian: Tenofovir difosfat slabi je inhibitor staničnih polimeraza α, β, i γ.
English: Some adult patients with HIV taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Croatian: U nekih odraslih bolesnika s HIV om koji uzimaju kombiniranu antiretrovirusnu terapiju može se razviti koštana bolest koja se zove osteonekrozom (odumiranje koštanog tkiva uzrokovano gubitkom dovoda krvi u kost).
English: Open bottles by pressing the child proof cap down and turning it counter-clock wise.
Croatian: Otvorite bocu tako da potisnete zatvarač siguran za djecu i okrenete ga u smjeru suprotnom od kazaljke na satu.
English: - In HBeAg negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy.
Croatian: - Kod HBeAg negativnih bolesnika bez ciroze, liječenje se mora primjenjivati najmanje do pojave HBs serokonverzije ili do dokaza gubitka djelotvornosti.
English: Severe renal impairment: 245 mg tenofovir disoproxil may be administered every 72 - 96 hours (dosing twice a week).
Croatian: Teško oštećenje funkcije bubrega: 245 mg tenofovirdizoproksila može se primijeniti svakih 72 - 96 sati (doziranje dva puta na tjedan).
English: If you think that you may have lactic acidosis, contact your doctor immediately.
Croatian: Ukoliko sumnjate da možda imate laktacidozu, odmah se javite svom liječniku.
English: You must continue to take precautions to avoid this.
Croatian: Da biste to izbjegli, morate i dalje poduzimati mjere opreza.
English: In vitro studies have determined that neither tenofovir disoproxil nor tenofovir are substrates for the CYP450 enzymes.
Croatian: In vitroispitivanja dokazala su da ni tenofovirdizoproksil ni tenofovir nisu supstrati za CYP450 enzime.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Croatian: Bolesnici s otprije postojećim poremećajem funkcije jetre, uključujući kronični aktivni hepatitis, imaju povećani broj abnormalnosti funkcije jetre tijekom kombinirane antiretrovirusne terapije (combination antiretroviral therapy, CART), pa ih treba nadzirati u skladu sa standardnom praksom.
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: In vitro vezanje tenofovira za proteine plazme ili serumabilo je manje od 0,7% odnosno 7,2%, u rasponu koncentracija tenofovira od 0,01 do 25 µg/ml.
English: The K65R mutation occurred in a slightly higher percentage of patients in the tenofovir disoproxil group than the active control group (2.7% versus 0.7%).
Croatian: Mutacija K65R pojavila se u bolesnika u skupini koja je primala tenofovirdizoproksil u nešto višem postotku nego u skupini koja je primala aktivnu kontrolu (2,7% prema 0,7%).
English: Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP450 mediated interactions involving tenofovir with other medicinal products is low.
Croatian: Na temelju rezultata in vitro pokusa i s obzirom na poznati put izlučivanja tenofovira, potencijal za interakcije posredstvom CYP450, koje uključuju tenofovirdizoproksila s drugim lijekovima je nizak.
English: It is not known whether tenofovir can be removed by peritoneal dialysis.
Croatian: Nije poznato može li se tenofovir ukloniti peritonejskom dijalizom.
English: It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with tenofovir disoproxil and renal function (creatinine clearance and serum phosphate) is also monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors.
Croatian: Preporučuje se, prije nego se započne terapija tenofovirdizoproksilom, izračunati klirens kreatinina u svih bolesnika te također pratiti funkciju bubrega (klirens kreatinina i fosfat u serumu) nakon dva do četiri tjedna liječenja, nakon tri mjeseca liječenja i svakih tri do šest mjeseci nakon toga u bolesnika bez bubrežnih čimbenika rizika.
English: Due to limitations of the study, a benefit of tenofovir disoproxil over placebo was not demonstrated based on plasma HIV-1 RNA levels at week 24.
Croatian: Zbog ograničenja ispitivanja nije se dokazala korist od tenofovirdizoproksila u usporedbi s placebom na temelju razina HIV-1 RNK u plazmi u 24. tjednu.
English: Experience beyond 48 weeks in study GS-US-174-0108
Croatian: Iskustva nakon 48 tjedana u ispitivanju GS-US-174-0108
English: Appropriate precautions must continue to be used.
Croatian: Bolesnici moraju i dalje primjenjivati odgovarajuće mjere opreza.
English: Moreover, at concentrations substantially higher (approximately 300-fold) than those observed in vivo, tenofovir did not inhibit in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation (CYP3A4, CYP2D6, CYP2C9, CYP2E1, or CYP1A1/2).
Croatian: Štoviše, u koncentracijama koje su znatno više (približno 300 puta) od onih koje su opažene in vivo, tenofovir nije inhibirao in vitro metabolizam lijekova koji se odvija posredstvom bilo kojeg od glavnih humanih izooblika enzima CYP450 uključenih u biotransformaciju lijekova (CYP3A4, CYP2D6, CYP2C9, CYP2E1 ili CYP1A1/2).
English: Genotoxicity studies revealed positive results in the in vitro mouse lymphoma assay, equivocal results in one of the strains used in the Ames test, and weakly positive results in an UDS test in primary rat hepatocytes.
Croatian: Ispitivanja genotoksičnosti dala su pozitivne rezultate u in vitro testu mišjeg limfoma, nepouzdane rezultate u jednom soju upotrijebljenom u Amesovom testu i slabo pozitivne rezultate UDS testa (engl. unscheduled DNA synthesis, UDS,; test neplanirane DNK sinteze) na primarnim hepatocitima štakora.
English: (11 subjects)
Croatian: (11 ispitanika)
English: If this applies to you, tell your doctor immediately and do not take Tenofovir disoproxil Zentiva.
Croatian: Ako se ovo odnosi na Vas, odmah o tome obavijestite liječnika i nemojte uzeti lijek Tenofovir disoproxil Zentiva.
English: Following intravenous administration the steady-state volume of distribution of tenofovir was estimated to be approximately 800 ml/kg.
Croatian: Nakon intravensk primjene procijenjeno je da je volumen distribucije tenofovira u stanju dinamičke ravnoteže bio približno 800 ml/kg.
English: Resistance: No HBV mutations associated with tenofovir disoproxil resistance have been identified (see Clinical efficacy and safety).
Croatian: Rezistencija: Nisu zabilježene mutacije virusa HBV povezane s rezistencijom na tenofovirdizoproksil (vidjeti Klinička djelotvornost i sigurnost).
English: Approximately 1% of tenofovir disoproxil -treated adult patients discontinued treatment due to the gastrointestinal events.
Croatian: Približno 1% odraslih bolesnika koji su liječeni tenofovirdizoproksilom prekinulo je liječenje zbog gastrointestinalnih događaja.
English: Adequate dose adjustments cannot be applied with this product due to lack of alternative tablet strengths, therefore use in this group of patients is not recommended.
Croatian: Zbog nedostatka drugih jačina tableta, nije moguće provesti odgovarajuće prilagodbe doze ovog lijeka pa se stoga ne preporučuje primjena u ovoj skupini bolesnika.
English: Exacerbations of hepatitis during treatment
Croatian: Egzacerbacije hepatitisa tijekom liječenja
English: Comparisons between treatment groups beyond week 24 are difficult to interpret since investigators had the option to intensify treatment to open-label emtricitabine plus tenofovir disoproxil.
Croatian: Usporedbe između terapijskih skupina nakon 24. tjedna teško je protumačiti, jer su ispitivači imali mogućnost intenzivirati liječenje emtricitabinom u kombinaciji s tenofovirdizoproksilom na otvoren način.
English: However, the subject's HBsAg loss was ultimately confirmed at the subsequent visit.
Croatian: Međutim u tog ispitanika nestanak HBsAg bio je naposlijetku potvrđen na sljedećem kontrolnom pregledu.
English: The effects of tenofovir disoproxil -associated changes in BMD on long-term bone health and future fracture risk are currently unknown (see section 5.1).
Croatian: Učinci promjena BMD-a povezani s tenofovirdizoproksilom na dugoročno zdravlje kostiju i rizik od budućih prijeloma za sada nisu poznati (vidjeti dio 5.1).
English: Pharmacotherapeutic group: Antiviral for systemic use; nucleoside and nucleotide reverse transcriptase inhibitors,
Croatian: Farmakoterapijska skupina: Antivirusni lijek za sistemsku primjenu: nukleozidni i nukleotidni inhibitori reverzne transkriptaze,
English: Warnings and precautions Talk to your doctor or pharmacist before taking Tenofovir disoproxil Zentiva
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Tenofovir disoproxil Zentiva.
English: Maximum tenofovir concentrations are observed in serum within one hour of dosing in the fasted state and within two hours when taken with food.
Croatian: Maksimalne se koncentracije tenofovira zapažaju u serumu unutar jednog sata nakon doziranja natašte te unutar dva sata kada se uzima s hranom.
English: If you have hepatitis B or HIV and hepatitis B together (co-infection), it is very important not to stop your Tenofovir disoproxil Zentiva treatment without talking to your doctor first.
Croatian: Ako imate hepatitis B ili istodobno i HIV infekciju i hepatitis B, vrlo je važno da se ne prestanete liječiti lijekom Tenofovir disoproxil Zentiva a da prije toga niste razgovarali s liječnikom.
English: If no alternative treatment is available, prolonged dose intervals using the 245 mg film-coated tablets may be used as follows:
Croatian: Ako nije dostupno alternativno liječenje, mogu se produljiti intervali između doza 245 mg filmom obloženih tableta, kako slijedi:
English: Late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Croatian: Rijetko su zabilježeni neurološki poremećaji s kasnim nastupom (hipertonija, konvulzija, abnormalno ponašanje).
English: Table 6: Histological response (%) in compensated HBeAg negative and HBeAg positive subjects at week 240 compared to baseline
Croatian: Tablica 6: Histološki odgovor (%) u kompenziranih HBeAg-negativnih i HBeAg-pozitivnih ispitanika u 240. tjednu u usporedbi s početnim stanjem
English: Mean (± SD) Cmax and AUCtau are 0.38 ± 0.13 μg/ml and 3.39 ± 1.22 μg h/ml, respectively.
Croatian: Srednja vrijednost (±SD) Cmax i AUCtau iznosi 0,38 ± 0,13 μg/ml odnosno 3,39 ± 1,22 μg·h/ml.
English: Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system with approximately 70 - 80% of the dose excreted unchanged in urine following intravenous administration.
Croatian: Tenofovir se prvenstveno izlučuje putem bubrega, filtracijom i aktivnim tubularnim transportnim sustavom, pri čemu se oko 70 - 80% doze izlučuje u nepromijenjenom obliku u mokraći nakon intravenske primjene.
English: However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Croatian: No tijekom 144 tjedna nije bilo povećanog rizika od prijeloma ili znakova klinički važnih abnormalnosti kosti.
English: increased creatinine, proximal renal tubulopathy (including Fanconi syndrome)
Croatian: povišen kreatinin, proksimalna bubrežna tubulopatija (uključujući Fanconijev sindrom)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with tenofovir disoproxil in one or more subsets of the paediatric population in HIV and chronic hepatitis B (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Tenofovir disoproxil Zentiva u jednoj ili više podskupina pedijatrijske populacije s HIV-om i kroničnim hepatitisom B (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Unless clearly necessary, concomitant use of these medicinal products which are secreted by the same renal pathway is not recommended, but if such use is unavoidable, renal function should be monitored weekly (see section 4.5).
Croatian: Osim kada je to jasno potrebno, ne preporučuje se istovremena primjena lijekova s istim bubrežnim putem sekrecije, ali ako se takva primjena ne može izbjeći, funkcija bubrega mora se pratiti jedanput na tjedan (vidjeti dio 4.5).
English: Tenofovir disoproxil Zentiva does not reduce the risk of passing on HBV to others through sexual contact or blood contamination.
Croatian: Tenofovir disoproxil Zentiva ne smanjuje rizik od prijenosa HBV-a na druge seksualnim kontaktom ili kontaminacijom krvlju.
English: HIV-1 and hepatitis B:
Croatian: HIV-1 i hepatitis B:
English: Hepatitis B: Approximately one quarter of patients can be expected to experience adverse reactions following treatment with tenofovir disoproxil, most of which are mild.
Croatian: Hepatitis B: Može se očekivati da će približno jedna četvrtina bolesnika razviti nuspojave nakon liječenja tenofovirdizoproksilom, većina koji su blage.
English: However, in some patients, declines in creatinine clearance did not completely resolve despite tenofovir disoproxil discontinuation.
Croatian: Međutim, u nekih se bolesnika smanjenje klirensa kreatinina nije potpuno riješilo usprkos prekidu terapije tenofovirdizoproksilom.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Croatian: Poredoportunističkih infekcija, autoimuni poremećaji (stanje koje se javlja kada imunološki sustav napada zdravo tkivo organizma) može se dogoditi nakon početka uzimanja lijekova za liječenje infekcije HIV-om.