FrancophonIA/ELRC3.0 huggingface dataset:
English: Protein binding/distribution: bexarotene is highly bound (>99%) to plasma proteins.
Croatian: Vezanje za proteine/distribucija: Beksaroten se u visokom postotku veže (>99%) za proteine plazme.
English: Effects on fertility cannot be excluded.
Croatian: Učinci na plodnost ne mogu se isključiti.
English: There are indications that bexarotene may induce CYP3A4.
Croatian: Postoje pokazatelji da beksaroten može inducirati CYP3A4.
English: Do not take Targretin:
Croatian: Nemojte uzimati Targretin:
English: The use of some retinoids has been associated with photosensitivity.
Croatian: Primjena nekih retinoida povezana je s fotoosjetljivošću.
English: Every attempt should be made to maintain triglyceride levels below 4.52 mmol/l in order to reduce the risk of clinical sequelae.
Croatian: Potrebno je na svaki način pokušati zadržati razine triglicerida ispod 4,52 mmol/l da bi se smanjio rizik od kliničkih posljedica.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX25
Croatian: Farmakoterapijska skupina: Ostali antineoplastici, ATK oznaka: L01XX25
English: In male dogs, some effects have been documented (see section 5.3).
Croatian: U mužjaka pasa, zabilježeni su neki učinci (vidjeti dio 5.3).
English: Absorption/dose proportionality: pharmacokinetics were linear up to a dose of 650 mg/m2.
Croatian: Apsorpcija/proporcionalnost doze: Farmakokinetika je bila linearna do doze od 650 mg/m
English: 100 soft capsules
Croatian: 100 mekih kapsula
English: Ongoing systemic infection.
Croatian: Prisutnost sistemske infekcije.
English: Carcinogenicity studies have not been conducted.
Croatian: Ispitivanja kancerogenosti nisu provedena.
English: Fertility studies have not been conducted; however, in sexually immature male dogs, reversible aspermatogenesis (28-day study) and testicular degeneration (91-day study) were seen.
Croatian: Ispitivanja učinaka na plodnost nisu provedena; međutim, u spolno nezrelih mužjaka pasa opažene su reverzibilna aspermatogeneza (28-dnevno ispitivanje) i testikularna degeneracija (91-dnevno ispitivanje).
English: What Targretin is and what it is used for
Croatian: Što je Targretin i za što se koristi
English: The overall response rate according to this composite assessment was 31% (19/61) with a clinical complete response rate of 7% (4/61).
Croatian: Ukupna stopa odgovora prema ovoj kompozitnoj ocjeni iznosila je 31% (19/61) uz stopu potpunog kliničkog odgovora od 7% (4/61).
English: It is not known whether Targretin has an effect on your ability to drive a car or operate machinery.
Croatian: Nije poznato utječe li Targretin na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: Because safety and efficacy data from clinical trials are based upon administration with food, it is recommended that Targretin capsules be administered with food.
Croatian: Budući da se podaci o sigurnosti i djelotvornosti iz kliničkih ispitivanja temelje na primjeni s hranom, preporučuje se primjenjivati Targretin kapsule s hranom.
English: Metabolism: bexarotene metabolites in plasma include 6- and 7-hydroxy-bexarotene and 6- and 7-oxo-bexarotene.
Croatian: Metaboliti beksarotena u plazmi uključuju 6- i 7-hidroksi-beksaroten i 6- i 7-oksobeksaroten.
English: Targretin is available as soft capsules for oral use in a white plastic bottle containing 100 capsules.
Croatian: Targretin je dostupan u obliku mekih kapsula za peroralnu primjenu u bijeloj plastičnoj bočici koja sadrži 100 kapsula.
English: Do not use this medicine after the expiry date which is stated on the label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici.
English: Targretin capsules should be taken as a single oral daily dose with a meal.
Croatian: Targretin kapsule uzimaju se kao jednokratna dnevna doza uz obrok.
English: It is recommended that two reliable forms of contraception be used together.
Croatian: Preporučuje se primjena dva pouzdana oblika kontracepcije istodobno.
English: In all clinical trials, patients were instructed to take Targretin capsules with or immediately following a meal.
Croatian: U svim kliničkim ispitivanjima, bolesnici su dobili uputu da uzimaju Targretin kapsule uz obrok ili neposredno nakon obroka.
English: If you are capable of becoming pregnant, you must have a pregnancy test within one week before you start therapy, confirming you are not pregnant.
Croatian: Ako možete zatrudnjeti, morate napraviti test na trudnoću unutar tjedan dana prije početka terapije radi potvrde da niste trudni.
English: When bexarotene was administered for six months to sexually mature dogs, no testicular effects were seen.
Croatian: Kad se beksaroten primjenjivao šest mjeseci spolno zrelim psima, nisu bili opaženi učinci na testise.
English: Responses were also determined by a composite score of five clinical signs (surface area, erythema, plaque elevation, scaling and hypo/hyperpigmentation) which also considered all extracutaneous CTCL manifestations.
Croatian: Odgovori su također bili određeni prema kompozitnom broju bodova za pet kliničkih znakova (veličina površine, eritem, odignuće plaka, ljuskanje i hipo/hiperpigmentacija), koji su također uzeli u obzir sve druge manifestacije CTCL-a izvan kože.
English: What Targretin is and what it is used for What you need to know before you take Targretin How to take Targretin
Croatian: Što je Targretin i za što se koristi Što morate znati prije nego počnete uzimati Targretin Kako uzimati Targretin
English: Consideration should be given to a suspension or discontinuation of bexarotene if test results reach greater than three times the upper limit of normal values for SGOT/AST, SGPT/ALT, or bilirubin.
Croatian: Potrebno je razmotriti privremeni ili trajni prekid primjene beksarotena ako rezultati pretraga dosegnu vrijednosti koje su povišene više od tri puta iznad gornje granice normale za SGOT/AST, SGPT/ALT ili bilirubin.
English: Bexarotene is contraindicated in pregnancy (see section 4.3).
Croatian: Beksaroten je kontraindiciran u trudnoći (vidjeti dio 4.3).
English: If this medicinal product is used inadvertently during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be informed of the potential hazard to the foetus.
Croatian: Ako se ovaj lijek nehotično primijeni tijekom trudnoće ili ako bolesnica zatrudni za vrijeme uzimanja ovog lijeka, bolesnicu treba obavijestiti o mogućem riziku za fetus.
English: In vivo, bexarotene causes tumour regression in some animal models and prevents tumour induction in others.
Croatian: In vivo, beksaroten uzrokuje regresiju tumora u nekih životinjskih modela i sprječava indukciju tumora u drugih.
English: Name and address of the manufacturer responsible for batch release Eisai Manufacturing Limited
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Eisai Manufacturing Limited
English: Gender has no statistically significant effect on bexarotene pharmacokinetics.
Croatian: Spol nema statistički značajan učinak na farmakokinetiku beksarotena.
English: Based on the comparison of animal and patient exposures to bexarotene, a margin of safety for human teratogenicity has not been demonstrated (see section 5.3).
Croatian: Na temelju usporedba izloženosti životinja i bolesnika beksarotenu, nije dokazano da postoji granica sigurnosti u pogledu teratogenosti kod ljudi (vidjeti dio 5.3).
English: What Targretin looks like and contents of the pack
Croatian: Kako Targretin izgleda i sadržaj pakiranja
English: Awareness by family or friends may be useful to detect mental health deterioration.
Croatian: Poželjno je s navedenim problemima upoznati obitelj ili prijatelje kako bi oni mogli uočiti pogoršanje psihičkog zdravlja.
English: Bexarotene is a synthetic compound that exerts its biological action through selective binding and activation of the three RXRs: , , and .
Croatian: Beksaroten je sintetski spoj koji iskazuje svoje biološko djelovanje kroz selektivno vezanje i aktivaciju tri RXR-ova: , , i .
English: Based on data from ongoing clinical trials, elevation of LFTs resolved within one month in 80% of patients following a decrease in dose or discontinuation of therapy.
Croatian: Na temelju podataka iz kliničkih ispitivanja koja su u tijeku, povišene vrijednosti jetrenih proba povukle bi se u roku od jednog mjeseca u 80% bolesnika nakon sniženja doze ili prekida terapije.
English: What Targretin contains
Croatian: Što Targretin sadrži
English: Once activated, these receptors function as transcription factors that regulate processes such as cellular differentiation and proliferation, apoptosis, and insulin sensitisation.
Croatian: Nakon aktivacije, ovi receptori funkcioniraju kao transkripcijski proteini koji reguliraju procese kao što su stanična diferencijacija i proliferacija, apoptoza i inzulinska senzibilizacija.
English: • gemfibrozil (used to reduce high levels of fats in the blood such as triglycerides and cholesterol),
Croatian: • gemfibrozil (primjenjuje se za sniženje povišenih razina masnoća u krvi kao što su trigliceridi i kolesterol),
English: Of these, liver failure, subsequently determined to be not related to bexarotene, was the only one to occur in a CTCL patient.
Croatian: Od njih je zatajenje jetre, za koje se kasnije ustanovilo da nije bilo povezano s beksarotenom, bila jedina koja se dogodila u bolesnika s CTCL-om.
English: The standard dose should be used in the elderly.
Croatian: U starijih bolesnika treba primijeniti standardnu dozu.
English: Patients should be advised to minimise exposure to sunlight and avoid sun lamps during therapy with bexarotene, as in vitro data indicate that bexarotene may potentially have a photosensitising effect.
Croatian: Bolesnicima treba savjetovati da smanje izlaganje sunčevom svjetlu i izbjegavaju svjetiljke za sunčanje za vrijeme terapije beksarotenom, jer podaci in vitro pokazuju da beksaroten može imati potencijalno fotosenzibilizirajući učinak.
English: Table 2 Adverse reactions reported in patients in clinical trials
Croatian: Tablica 2 Nuspojave zabilježene u bolesnika u kliničkim ispitivanjima
English: Excretion: neither bexarotene nor its metabolites are excreted in urine in any appreciable amounts.
Croatian: Izlučivanje: Niti beksaroten niti njegovi metaboliti ne izlučuju se mokraćom u nekim zamjetnim količinama.
English: Blood tests to evaluate the function of your liver and thyroid gland and to monitor your red blood cell and white blood cell counts will be obtained before therapy is started and will be monitored during therapy.
Croatian: Krvne pretrage za procjenu funkcije jetre i štitne žlijezde i za praćenje crvene i bijele krvne slike napravit će se prije nego što započne terapija, a nadzirat će se i tijekom terapije.
English: Swelling of legs and arms.
Croatian: Oticanje nogu i ruku.
English: The capsule should not be chewed.
Croatian: Kapsule se ne smiju žvakati.
English: Patients should be monitored for signs of depression and referred for appropriate treatment if necessary.
Croatian: Bolesnike treba nadzirati kako bi se uočili mogući znakovi depresije te ih prema potrebi uputiti na odgovarajuće liječenje.
English: Marketing Authorisation Holder Eisai GmbH
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Eisai GmbH
English: In view of the limited data, patients with renal insufficiency should be monitored carefully while on bexarotene therapy.
Croatian: S obzirom na ograničene podatke, bolesnike s insuficijencijom bubrega potrebno je pažljivo nadzirati dok su na terapiji beksarotenom.
English: Age: Based on the population pharmacokinetic analysis of data for 232 patients aged ≥ 65 years and 343 patients aged < 65 years, age has no statistically significant effect on bexarotene pharmacokinetics.
Croatian: Dob: Na temelju populacijske farmakokinetičke analize podataka prikupljenih u 232 bolesnika u dobi od ≥ 65 godina i 343 bolesnika u dobi od < 65 godina, dob nema statistički značajan učinak na farmakokinetiku beksarotena.
English: A negative, sensitive, pregnancy test (e.g. serum beta-human chorionic gonadotropin, beta-HCG) should be obtained within one week prior to bexarotene therapy.
Croatian: Osjetljiv test na trudnoću (npr. određivanje beta-humanog korionskog gonadotropina, beta-HCG, u serumu) treba biti negativan unutar jednog tjedna prije terapije beksarotenom.
English: This is because taking Targretin may affect your mood.
Croatian: Naime, Targretin može utjecati na raspoloženje.
English: Based on the known mechanism of action, bexarotene may potentially enhance the action of these agents, resulting in hypoglycaemia.
Croatian: Na temelju poznatog mehanizma djelovanja, beksaroten može potencijalno pojačati djelovanje ovih lijekova, što može rezultirati hipoglikemijom.
English: Among the 61 patients treated at an initial dose of 300 mg/m2/day, the overall response rate, according to a global assessment by the physician, was 51% (31/61) with a clinical complete response rate of 3%.
Croatian: Kod 61 bolesnika liječenih početnom dozom od 300 mg/m2 na dan, ukupna stopa odgovora, prema općoj procjeni liječnika, iznosila je 51% (31/61) uz stopu potpunog kliničkog odgovora od 3%.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su prikazane redoslijedom prema sve manjoj ozbiljnosti.
English: Body Weight and Gender: Based on the population pharmacokinetics analysis of data for 614 patients with a weight range of 26 to 145 kg, the bexarotene apparent clearance increases with increasing body weight.
Croatian: Tjelesna težina i spol: Na temelju populacijske farmakokinetičke analize podataka prikupljenih u 614 bolesnika tjelesne težine u rasponu od 26 do 145 kg, prividni klirens beksarotena povećava se s povećanjem tjelesne težine.
English: The majority of cases resolved after dose reduction or discontinuation of treatment.
Croatian: Većina slučajeva riješila se nakon sniženja doze ili prekida liječenja.
English: No evidence of prolonged accumulation was observed.
Croatian: Nije bilo opaženih dokaza produljenog nakupljanja.
English: OUTER CARTON TEXT AND BOTTLE LABEL TEXT
Croatian: TEKST NA KUTIJI I TEKST NA NALJEPNICI BOČICE
English: Bexarotene, in common with the majority of retinoids, was teratogenic and embryotoxic in an animal test species at systemic exposures that are achievable clinically in humans.
Croatian: Beksaroten je, kao i većina retinoida, bio teratogen i embriotoksičan u životinjskih ispitnih vrsta pri sistemskoj izloženosti koja se klinički može postići u ljudi.
English: The active substance in Targretin, bexarotene, belongs to a group of medicines known as retinoids, which are related to vitamin A.
Croatian: Djelatna tvar u Targretinu, beksaroten, pripada skupini lijekova koji se zovu retinoidi i slični su vitaminu A.
English: Common (can occur in up to 1 in 10 patients treated):
Croatian: Često (mogu nastati u do 1 na 10 liječenih bolesnika):
English: However, the exact mechanism of action of bexarotene in the treatment of cutaneous T-cell lymphoma (CTCL) is unknown.
Croatian: Međutim, točan mehanizam djelovanja beksarotena u liječenju kožnog limfoma T-stanica (CTCL) nije poznat.
English: There are insufficient data to evaluate potential differences in the pharmacokinetics of bexarotene for other races.
Croatian: Nema dovoljno podataka da bi se mogle procijeniti razlike u farmakokinetici beksarotena kod drugih rasa.
English: Particular care should be taken in patients with a history of depression.
Croatian: Potreban je poseban oprez u bolesnika s depresijom u anamnezi.
English: Elevation of blood fats (triglycerides and cholesterol).
Croatian: Povišenje masnoća u krvi (triglicerida i kolesterola).
English: High-density polyethylene bottles with child-resistant closures containing 100 capsules.
Croatian: Bočice od polietilena visoke gustoće sa sigurnosnim zatvaračem za djecu koje sadrže 100 kapsula.
English: Thus, if treatment with bexarotene is intended in a woman with childbearing potential, a reliable, non-hormonal contraceptive method is also recommended.
Croatian: Stoga, ako se planira liječenje beksarotenom u žene reproduktivne dobi, preporučuje se i pouzdana, nehormonska metoda kontracepcije.
English: Following repeat once daily dose administration at dose levels  230 mg/m2, Cmax and AUC in some patients were less than respective single dose values.
Croatian: Nakon ponovljene primjene doze jedanput dnevno u veličini od  230 mg/m2, Cmax i AUC u nekih su bolesnika bile manje od onih nakon jednokratne doze.
English: Fasting blood lipid determinations (triglycerides and cholesterol) should be performed before bexarotene therapy is initiated and at weekly intervals until the lipid response to bexarotene is established, which usually occurs within two to four weeks, and then at intervals no less than monthly thereafter.
Croatian: Lipide u krvi natašte (trigliceride i kolesterol) potrebno je odrediti prije uvođenja terapije beksarotenom te svakih tjedan dana sve dok se ne ustanovi odgovor lipida na beksaroten, što se obično dogodi unutar dva do četiri tjedna, a zatim u vremenskim razmacima od najmanje mjesec dana.
English: Pregnancy and lactation.
Croatian: Trudnoća i dojenje.
English: With appropriate clinical monitoring, individual patients may benefit from doses above 300 mg/m 2/day.
Croatian: Uz odgovarajući klinički nadzor, pojedini bolesnici mogu imati koristi i od doza viših od 300 mg/m2 na dan.
English: However, among a total of 810 patients, including those without malignancy, treated with bexarotene, there were three serious adverse reactions with fatal outcome (acute pancreatitis, subdural haematoma and liver failure).
Croatian: Međutim, u 810 bolesnika liječenih beksarotenom, uključujući one bez zloćudne bolesti, zabilježene su tri ozbiljne nuspojave sa smrtnim ishodom (akutni pankreatitis, subduralni hematom i zatajenje jetre).
English: Given the high prevalence and natural rate of cataract formation in the older patient population represented in the clinical studies, there was no apparent association between the incidence of lens opacity formation and bexarotene administration.
Croatian: S obzirom na visoku prevalenciju i prirodnu stopu stvaranja katarakte u populaciji starijih bolesnika zastupljenih u kliničkim ispitivanjima, nije bilo vidljive povezanosti između incidencije nastanka zamućenja leće i primjene beksarotena.
English: If fasting triglycerides are elevated or become elevated during treatment, institution of antilipaemic therapy is recommended, and if necessary, dose reductions (from 300 mg/m2/day of bexarotene to 200 mg/m2/day, and if necessary to 100 mg/m2/day) or treatment discontinuation.
Croatian: Ako su trigliceridi natašte povišeni ili postanu povišeni tijekom liječenja, preporučuje se uvesti terapiju antilipemicima, a po potrebi i sniziti dozu beksarotena (s 300 mg/m2 na dan na 200 mg/m2 na dan, a po potrebi i na 100 mg/m2 dan) ili prekinuti liječenje.
English: • tamoxifen (used against some forms of cancer),
Croatian: • tamoksifen (primjenjuje se protiv nekih oblika raka),
English: • erythromycin, clarithromycin and rifampicin (used against bacterial infections),
Croatian: • eritromicin, klaritromicin i rifampicin (primjenjuju se protiv bakterijskih infekcija),
English: Off-white capsule, containing a liquid suspension and imprinted with “Targretin”.
Croatian: Gotovo bijela kapsula koja sadrži tekuću suspenziju i otisnutu oznaku “Targretin”.
English: Targretin capsules should be used with caution in patients with a known hypersensitivity to retinoids.
Croatian: Targretin kapsule treba primjenjivati s oprezom u bolesnika s poznatom preosjetljivošću na retinoide.
English: Thus, if treatment with bexarotene is intended in a woman of childbearing potential, a reliable, non-hormonal form of contraception is also required, because bexarotene belongs to a therapeutic class for which the human malformative risk is high.
Croatian: Stoga, ako se planira liječenje beksarotenom u žena reproduktivne dobi, potreban je i pouzdan, nehormonski oblik kontracepcije, zato što beksaroten pripada terapijskoj skupini s visokim rizikom od uzrokovanja malformacija u ljudi.
English: If you experience dizziness or problems with your vision during therapy, do not drive or operate machinery.
Croatian: Ako osjetite omaglicu ili tegobe s vidom tijekom terapije, nemojte upravljati vozilima niti raditi sa strojevima.
English: However, concomitant administration of gemfibrozil resulted in substantial increases in plasma concentrations of bexarotene and therefore, concomitant administration of gemfibrozil with bexarotene is not recommended (see section 4.5).
Croatian: Međutim, istodobna primjena gemfibrozila rezultirala je znatnim povišenjima koncentracija beksarotena u plazmi pa se stoga ne preporučuje istodobna primjena gemfibrozila i beksarotena (vidjeti dio 4.5).
English: If you have an intolerance to some sugars, speak to your doctor before taking this medicinal product.
Croatian: Ako ne podnosite neke šećere, obratite se liječniku prije nego što uzmete ovaj lijek.
English: Doses greater than 650 mg/m 2/day have not been evaluated in patients with CTCL.
Croatian: Doze veće od 650 mg/m2 na dan nisu ispitane u bolesnika s CTCL.
English: The recommended initial dose is 300 mg/m 2/day.
Croatian: Preporučena početna doza je 300 mg/m 2 na dan.
English: The following Targretin-related adverse reactions were reported during clinical studies in patients with CTCL (N=109) treated at the recommended initial dose of 300 mg/m2/day.
Croatian: Sljedeće nuspojave povezane s Targretinom bile su zabilježene tijekom kliničkih ispitivanja u bolesnika s CTCL (N=109) liječenih preporučenom početnom dozom od 300 mg/m2 na dan.
English: Table 1 Recommended initial dose Initial dose level (300 mg/m2/day)
Croatian: Tablica 1 Preporučena početna doza Razina početne doze (300 mg/m2 na dan)
English: How long you should take Targretin
Croatian: Koliko dugo trebate uzimati Targretin
English: Therefore, repeated administration of bexarotene may result in an auto-induction of its own metabolism and, particularly at dose levels greater than 300 mg/m2/day, may increase the rate of metabolism and reduce plasma concentrations of other substances metabolised by cytochrome P450 3A4, such as tamoxifen.
Croatian: Stoga ponovljena primjena beksarotena može rezultirati autoindukcijom njegovog vlastitog metabolizma te, osobito pri razinama doza višima od 300 mg/m2 na dan, povećati brzinu metabolizma i smanjiti koncentracije u plazmi drugih tvari koje metabolizira citokrom P450 3A4, kao što je tamoksifen.
English: If you take more Targretin than you should If you have taken more than the prescribed dose of Targretin, you must contact your doctor.
Croatian: Ako ste uzeli više od propisane doze Targretin, morate se obratiti liječniku.
English: Effective contraception must be used from the time of the negative pregnancy test through the initiation of therapy, during therapy and for at least one month following discontinuation of therapy.
Croatian: Nužno je koristiti učinkovitu kontracepciju od vremena negativnog rezultata testa na trudnoću pa tijekom početka terapije, njezina trajanja i najmanje jedan mjesec nakon prestanka terapije.
English: For example bexarotene may reduce the efficacy of oral contraceptives (see sections 4.4 and 4.6).
Croatian: Na primjer, beksaroten može smanjiti djelotvornost oralnih kontraceptiva (vidjeti dijelove 4.4 i
English: What you need to know before you take Targretin
Croatian: Što morate znati prije nego počnete uzimati Targretin
English: Doses up to 1000 mg/m 2/day of bexarotene have been administered in clinical studies with no acute toxic effects.
Croatian: Doze beksarotena do 1000 mg/m 2 na dan primijenjene su u kliničkim ispitivanjima bez akutnih toksičnih učinaka.
English: At the recommended initial daily-dose level (300 mg/m2), single-dose and repeated daily-dose bexarotene pharmacokinetic parameters were similar.
Croatian: Na razini preporučene početne dnevne doze (300 mg/m2), farmakokinetički parametri beksarotena nakon jednokratne primjene i ponovljene dnevne doze bili su slični.