FrancophonIA/ELRC3.0 huggingface dataset:
English: Bexarotene has a different adverse reaction profile to other oral, non-retinoid X receptor (RXR)-selective retinoids.
Croatian: Beksaroten ima različit profil nuspojava od drugih peroralnih retinoida koji nisu selektivni za retinoidni X receptor (RXR).
English: The capsules also contain the other ingredients macrogol, polysorbate, povidone and butylated hydroxyanisole.
Croatian: Kapsule također sadrže druge sastojke kao što su makrogol, polisorbat, povidon i butilhidroksianizol.
English: Based on the in vitro binding and the retinoid receptor activation profile of the metabolites, and on the relative amounts of individual metabolites in plasma, the metabolites have little impact on the pharmacological profile of retinoid receptor activation by bexarotene.
Croatian: Na temelju vezanja in vitro i profila aktivacije retinoidnih receptora metabolita te na temelju relativnih količina pojedinih metabolita u plazmi, ti metaboliti malo utječu na farmakološki profil aktivacije retinoidnih receptora beksarotenom.
English: Proteins in urine, abnormal kidney function.
Croatian: Proteini u mokraći, abnormalna funkcija bubrega.
English: Following bexarotene treatment, some patients were observed to have previously undetected lens opacities or a change in pre-existing lens opacities unrelated to treatment duration or dose level of exposure.
Croatian: Nakon liječenja beksarotenom, opaženo je da su neki bolesnici imali prethodno neprimijećena zamućenja leće ili promjene već postojećih zamućenja leće koje nisu bile povezane s trajanjem liječenja ili razinom doze kojoj su bili izloženi.
English: Patients who experience dizziness or visual difficulties during therapy must not drive or operate machinery.
Croatian: Bolesnici koji osjete omaglicu ili poteškoće s vidom tijekom terapije ne smiju upravljati vozilima niti raditi sa strojevima.
English: In clinical trials, bexarotene was administered for up to 118 weeks to patients with CTCL.
Croatian: U kliničkim ispitivanjima, beksaroten se primjenjivao do 118 tjedana bolesnicima s CTCL.
English: No formal studies to evaluate interactions with bexarotene have been conducted.
Croatian: Nisu provedena službena ispitivanja procjene interakcija s beksarotenom.
English: Uncommon (can occur in up to 1 in 100 patients treated):
Croatian: Manje često (mogu nastati u do 1 na 100 liječenih bolesnika):
English: In all evaluated patients, the estimated renal clearance of bexarotene was less than 1 ml/minute.
Croatian: U svih ispitanih bolesnika, procijenjeni klirens beksarotena bio je manji od 1 ml/minuti.
English: You must use effective contraception (birth control) continuously starting one month before beginning therapy until one month after you stop taking Targretin.
Croatian: Morate neprekidno koristiti učinkovitu kontracepciju (metodu kontrole začeća) počevši mjesec dana prije početka terapije pa sve do mjesec dana nakon prestanka uzimanja Targretina.
English: Owing to its primarily RXR-binding activity, bexarotene is less likely to cause mucocutaneous, nail, and hair toxicities; arthralgia; and myalgia; which are frequently reported with retinoic acid receptor (RAR) -binding agents.
Croatian: Zahvaljujući primarno svojem vezanju za RXR, manja je vjerojatnost da će beksaroten prouzročiti toksične učinke na sluznice, nokte i kosu; artralgiju i mialgiju, koje su često zabilježene uz tvari koja se vežu za receptore retinoične kiseline (RAR).
English: The ability of the RXRs to form heterodimers with various receptor partners that are important in cellular function and in physiology indicates that the biological activities of bexarotene are more diverse than those of compounds that activate the RARs.
Croatian: Sposobnost RXR-ova da oblikuju heterodimere s raznim srodnim receptorima koji su važni za funkciju i fiziologiju stanice pokazuje da je biološko djelovanje beksarotena raznolikije od biološkog djelovanja spojeva koji aktiviraju RAR-ove.
English: Any patient treated with bexarotene who experiences visual difficulties should have an appropriate ophthalmologic examination.
Croatian: Svakog bolesnika liječenog beksarotenom koji opazi poteškoće s vidom treba primjereno oftalmološki pregledati.
English: • vitamin A supplements, protease inhibitors (used against viral infections),
Croatian: • nadomjesci vitamina A, inhibitori proteaze (primjenjuju se protiv virusnih infekcija),
English: If you are male and your partner is pregnant or capable of becoming pregnant, you must use condoms during sexual intercourse while taking bexarotene and for at least one month after the last dose.
Croatian: Ako ste muškarac i Vaša je partnerica trudna ili može zatrudnjeti, morate upotrebljavati kondome tijekom spolnog odnosa dok uzimate beksaroten te tijekom najmanje mjesec dana nakon posljednje doze.
English: Headache, fatigue, pain.
Croatian: Glavobolja, umor, bol.
English: Bexarotene capsules were evaluated in clinical trials of 193 patients with CTCL of whom 93 had advanced stage disease refractory to prior systemic therapy.
Croatian: Beksaroten kapsule bile su procijenjene u kliničkim ispitivanjima u 193 bolesnika s CTCL od kojih je 93 imalo uznapredovali stadij bolesti otporan na prethodnu sistemsku terapiju.
English: A population analysis of plasma bexarotene concentrations in patients with CTCL indicated that concomitant administration of gemfibrozil resulted in substantial increases in plasma concentrations of bexarotene.
Croatian: Populacijska analiza koncentracije beksarotena u plazmi u bolesnika s CTCL-om pokazala je da istodobna primjena gemfibrozila dovodi do znatnog povećanja koncentracija beksarotena u plazmi.
English: In vitro, bexarotene inhibits the growth of tumour cell lines of haematopoietic and squamous cell origin.
Croatian: In vitro, beksaroten inhibira rast tumorskih staničnih linija koje potječu od hematopoetskih i skvamoznih stanica.
English: No clinical instances of cross-reactivity have been noted.
Croatian: Nisu primijećeni klinički slučajevi križne preosjetljivosti.
English: CTCL is a condition in which certain cells of the body's lymph system called T-lymphocytes become cancerous and affect the skin.
Croatian: Kožni limfom T-stanica je stanje u kojem određene stanice limfnog sustava u tijelu, koje se zovu T-limfociti, postanu stanice raka i zahvate kožu.
English: The capsules should be swallowed whole and not chewed.
Croatian: Kapsule se moraju progutati cijele i bez žvakanja.
English: • ketoconazole and itraconazole (used against fungal infections),
Croatian: • ketokonazol i itrakonazol (primjenjuju se protiv gljivičnih infekcija),
English: Capsule content: macrogol polysorbate povidone butylated hydroxyanisole
Croatian: Sadržaj kapsule: makrogol polisorbat povidon butilhidroksianizol
English: Clinical pharmacokinetic data indicate that urinary elimination of bexarotene and its metabolites is a minor excretory pathway for bexarotene.
Croatian: Klinički farmakokinetički podaci pokazuju da je eliminacija beksarotena i njegovih metabolita putem mokraće manji put izlučivanja beksarotena.
English: Patients with CTCL having risk factors for pancreatitis (e.g., prior episodes of pancreatitis, uncontrolled hyperlipidaemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity) should not be treated with bexarotene, unless the potential benefit outweighs the risk.
Croatian: Bolesnici s CTCL-om koji imaju čimbenike rizika za pankreatitis (npr. prethodne epizode pankreatitisa, nekontroliranu hiperlipidemiju, prekomjerno konzumiranje alkohola, nekontroliran dijabetes melitus, bolest žučnih puteva i uzimanje lijekova za koje se zna da povećavaju razine triglicerida ili da su povezani s toksičnošću za gušteraču) ne smiju biti liječeni beksarotenom, osim ako je moguća korist veća od rizika.
English: It may be asymptomatic and responds to treatment with thyroxine and resolves upon withdrawal of treatment.
Croatian: Može biti asimptomatski i odgovara na liječenje tiroksinom te se povlači nakon prestanka liječenja.
English: No clinical experience with an overdose of Targretin has been reported.
Croatian: Nema zabilježenog kliničkog iskustva s preodoziranjem lijekom Targretin.
English: Elevation of liver enzymes, impaired kidney function, low protein in blood, weight gain.
Croatian: Povišenje jetrenih enzima, narušena funkcija bubrega, niski proteini u krvi, povećanje tjelesne težine.
English: Changes in thyroid function tests have been observed in patients receiving bexarotene, most often noted as a reversible reduction in thyroid hormone (total thyroxine [total T4]) and thyroid-stimulating hormone (TSH) levels.
Croatian: Promjene rezultata pretraga štitne žlijezde opažene su u bolesnika koji su primali beksaroten, najčešće kao reverzibilno sniženje hormona štitne žlijezde (razine ukupnog tiroksina [ukupni T4]) i hormona koji stimulira štitnu žlijezdu (TSH).
English: Uncontrolled hypercholesterolaemia.
Croatian: Nekontrolirana hiperkolesterolemija.
English: No formal studies have been conducted in patients with renal insufficiency.
Croatian: Nisu provedena službena ispitivanja u bolesnika s insuficijencijom bubrega.
English: Elevated bilirubin in the blood, impaired kidney function, gout, decreased HDL cholesterol.
Croatian: Povišen bilirubin u krvi, oštećena funkcija bubrega, giht, snižen HDL kolesterol.
English: Patients with diabetes mellitus
Croatian: Bolesnici s dijabetesom melitusom
English: There are no human data on the effect of bexarotene on fertility.
Croatian: Nema podataka za ljude o učinku beksarotena na plodnost.
English: Male patients with sexual partners who are pregnant, possibly pregnant, or may potentially become pregnant must use condoms during sexual intercourse while taking bexarotene and for at least one month after the last dose.
Croatian: Bolesnici muškog spola čije su spolne partnerice trudne, možda su trudne ili bi mogle zatrudnjeti moraju koristiti kondome tijekom spolnih odnosa za vrijeme uzimanja beksarotena i najmanje jedan mjesec nakon posljednje doze.
English: In one clinical study, plasma bexarotene AUC and Cmax values were substantially higher following the administration of a fat-containing meal versus those following the administration of a glucose solution.
Croatian: U jednom kliničkom ispitivanju, AUC i Cmax vrijednosti beksarotena u plazmi bile su znatno više nakon primjene obroka koji je sadržavao masti od onih nakon primjene otopine glukoze.
English: The safety of bexarotene has been examined in clinical studies of 193 patients with CTCL who received bexarotene for up to 118 weeks and in 420 non-CTCL cancer patients in other studies.
Croatian: Sigurnost beksarotena ispitana je u kliničkim ispitivanjima u 193 bolesnika s CTCL-om koji su primali beksaroten do najviše 118 tjedana i u 420 onkoloških bolesnika bez CTCL-a u drugim ispitivanjima.
English: Chills, abdominal pain, allergic reaction, infection.
Croatian: Zimice, bol u trbuhu, alergijska reakcija, infekcija.
English: Renal excretion is not a significant elimination pathway for bexarotene.
Croatian: Bubrežno izlučivanje nije značajan put eliminacije beksarotena.
English: Blood disorders, eosinophilia, leukocytosis, lymphocytosis, purpura, elevated and decreased numbers of blood platelets.
Croatian: Poremećaji krvi, eozinofilija, leukocitoza, limfocitoza, purpura, povišeni i sniženi broj krvnih pločica.
English: Bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestive contraceptives.
Croatian: Beksaroten može potencijalno inducirati metaboličke enzime i tako teoretski smanjiti djelotvornost estrogensko-progestagenske kontracepcije.
English: Elevations of serum cholesterol should be managed according to current medical practice.
Croatian: Povišenja serumskog kolesterola treba liječiti sukladno važećoj medicinskoj praksi.
English: Lowering of thyroid hormones level.
Croatian: Sniženje razine hormona štitne žlijezde.
English: There are no adequate data from the use of bexarotene in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni beksarotena u trudnica.
English: Effects of other substances on bexarotene
Croatian: Učinci drugih tvari na beksaroten
English: Women of childbearing potential must use adequate birth-control measures when bexarotene is used.
Croatian: Žene reproduktivne dobi moraju primjenjivati odgovarajuće mjere kontrole začeća kad uzimaju beksaroten.
English: Concomitant administration of gemfibrozil with bexarotene is not recommended.
Croatian: Ne preporučuje se istodobna primjena gemfibrozila s beksarotenom.
English: Bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestative contraceptives (see section 4.5).
Croatian: Beksaroten može potencijalno inducirati metaboličke enzime i tako teoretski smanjiti djelotvornost estrogensko-progestagenske kontracepcije (vidjeti dio 4.5).
English: If you stop taking Targretin
Croatian: Ako prestanete uzimati Targretin
English: In 109 patients with CTCL treated at the recommended initial dose of 300 mg/m2/day, the most commonly reported adverse reactions to Targretin were hyperlipaemia ((primarily elevated triglycerides) 74%), hypothyroidism (29%), hypercholesterolaemia (28%), headache (27%), leucopenia (20%), pruritus (20%), asthenia (19%), rash (16%), exfoliative dermatitis (15%), and pain
Croatian: U 109 bolesnika s CTCL-om liječenih preporučenom početnom dozom od 300 mg/m2 na dan, najčešće zabilježene nuspojave Targretina bile su hiperlipemija ((primarno povišeni trigliceridi) 74%), hipotiroidizam (29%), hiperkolesterolemija (28%), glavobolja (27%), leukopenija (20%), pruritus (20%), astenija (19%), osip (16%), eksfolijativni dermatitis (15%) i bol (12%).
English: Agitation, difficulties with balance, depression, increased skin sensation on touching, abnormal nerve sensations, vertigo.
Croatian: Uznemirenost, poteškoće s ravnotežom, depresija, pojačan osjet dodira na koži, abnormalni živčani osjeti, vrtoglavica.
English: Swelling, bleeding, high blood pressure, fast heart rate, visible vein enlargement, dilation of blood vessels.
Croatian: Oticanje, krvarenje, povišen krvni tlak, ubrzan rad srca, vidljivo povećanje vena, proširenje krvnih žila.
English: Women of child-bearing potential without effective birth-control measures.
Croatian: Žene reproduktivne dobi koje ne koriste učinkovite mjere kontrole začeća.
English: Your fasting blood lipid determinations may have to be performed before therapy is initiated and at weekly intervals afterwards, and then monthly while taking this medicine.
Croatian: Možda će Vam biti potrebno izmjeriti lipide u krvi natašte prije početka terapije i u tjednim razmacima nakon toga, a potom svakog mjeseca dok uzimate ovaj lijek.
English: Effects of bexarotene on other substances
Croatian: Učinci beksarotena na druge tvari
English: Skin reactions (Itching, redness, irritation, peeling).
Croatian: Kožne reakcije (svrbež, crvenilo, nadraženost, ljuštenje).
English: Generally, these resolved without sequelae on dose reduction or withdrawal of treatment.
Croatian: Općenito, ove su se nuspojave povukle bez posljedica na sniženje doze ili prekid liječenja.
English: Dry eyes, deafness, abnormal sensations of the eye including irritation and heaviness.
Croatian: Suhe oči, gluhoća, abnormalni osjeti u oku uključujući nadraženost i težinu.
English: Race: Based on the population pharmacokinetic analysis of data for 540 Caucasian and 44 Black patients, bexarotene pharmacokinetics are similar in Blacks and Caucasians.
Croatian: Rasa: Na temelju populacijske farmakokinetičke analize podataka za 540 bijelaca i 44 crnca, bijelci i crnci imaju sličnu farmakokinetiku beksarotena.
English: If you forget to take Targretin
Croatian: Ako ste zaboravili uzeti Targretin
English: Patients with symptomatic hypothyroidism on bexarotene therapy have been treated with thyroid hormone supplements with resolution of symptoms.
Croatian: Bolesnici sa simptomatskim hipotireoidizmom na terapiji beksarotenom liječeni su nadomjescima hormona štitne žlijezde uz povlačenje simptoma.
English: Butylated hydroxyanisole, an ingredient in Targretin, may cause irritation to the mucous membranes, therefore the capsules must be swallowed intact and not chewed.
Croatian: Butilhidroksianizol, sastojak u Targretinu, može prouzročiti nadraženost sluznica pa se stoga kapsule moraju progutati cijele i ne smiju se žvakati.
English: Fasting triglycerides should be normal or normalised with appropriate intervention prior to bexarotene therapy.
Croatian: Prije terapije beksarotenom, trigliceridi natašte trebaju biti normalni ili normalizirani odgovarajućom intervencijom.
English: Targretin contains sorbitol and butylated hydroxyanisole Targretin contains a small amount of sorbitol (a type of sugar).
Croatian: Targretin sadrži malu količinu sorbitola (vrsta šećera).
English: In vitro studies suggest glucuronidation as a metabolic pathway, and that cytochrome P450 3A4 is the major cytochrome P450 isozyme responsible for formation of the oxidative metabolites.
Croatian: In vitro ispitivanja ukazuju na glukuronidaciju kao metabolički put te da je citokrom P450 3A4 glavni izoenzim citokroma P450 odgovoran za stvaranje oksidativnih metabolita.
English: Additional adverse reactions observed when used outside of the recommended dose and indication (i.e. used in CTCL at an initial dose >300mg/m2/day or in non-CTCL cancer indications):
Croatian: Dodatne nuspojave opažene kod primjene doza izvan preporučenih razina i indikacije (tj. primijenjenih kod CTCL-a u početnoj dozi od >300 mg/m2 na dan ili onkoloških indikacija bez CTCL-a):
English: Rare fatal side effects are acute inflammation of the pancreas, bleeding in the head, and liver failure.
Croatian: Rijetke nuspojave sa smrtnim ishodom su akutna upala gušterače, krvarenje u glavi i zatajenje jetre.
English: Caution is advised in case of combination with CYP3A4 substrates having a narrow therapeutic margin i.e. immunosuppressive agents (cyclosporine, tacrolimus, sirolimus) as well as CYP3A4-metabolised cytotoxics, i.e. cyclophosphamide, etoposide, finasteride, ifosfamide, tamoxifen, vinca-alcaloids.
Croatian: Savjetuje se oprez u slučaju kombinacije sa supstratima CYP3A4 koji imaju uzak terapijski raspon, tj. imunosupresivima (ciklosporinom, takrolimusom, sirolimusom) kao i citotoksičnim lijekovima koje metabolizira CYP3A4, tj. ciklofosfamidom, etoposidom, finasteridom, ifosfamidom, tamoksifenom i vinka alkaloidima.
English: Uncontrolled hypertriglyceridaemia.
Croatian: Nekontrolirana hipertrigliceridemija.
English: On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4), coadministration with other CYP3A4 substrates such as ketoconazole, itraconazole, protease inhibitors, clarithromycin and erythromycin may theoretically lead to an increase in plasma bexarotene concentrations.
Croatian: Na temelju oksidativnog metabolizma beksarotena putem citokroma P450 3A4 (CYP3A4), istodobna primjena s drugim supstratima CYP3A4 kao što su ketokonazol, itrakonazol, inhibitori proteaze, klaritromicin i eritromicin, može teoretski dovesti do povećanja koncentracije beksarotena u plazmi.
English: Low red blood cell count, enlarged lymph nodes, worsening of lymphoma.
Croatian: Nizak broj crvenih krvnih stanica, povećani limfni čvorovi, pogoršanje limfoma.
English: Irreversible cataracts involving the posterior area of the lens occurred in rats and dogs treated with bexarotene at systemic exposures that are achievable clinically in humans.
Croatian: Ireverzibilna katarakta koja zahvaća stražnju stranu leće nastala je u štakora i pasa liječenih beksarotenom pri sistemskoj izloženosti koja se može postići u ljudi.
English: Targretin is indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) in adult patients refractory to at least one systemic treatment.
Croatian: Targretin je indiciran za liječenje kožnih promjena u odraslih bolesnika s uznapredovalim stadijem kožnog limfoma T-stanica refraktornog na najmanje jedno sistemsko liječenje.
English: History of pancreatitis.
Croatian: Pankreatitis u povijesti bolesti.
English: Muscle weakness.
Croatian: Mišićna slabost.
English: Talk to your doctor before taking Targretin - if you have a known hypersensitivity to retinoids (related to vitamin A), suffer from liver disease, have high blood lipids or take medicines which may cause high blood lipids, have uncontrolled diabetes mellitus (sugar diabetes), have had gall bladder or biliary tract disease, or consume excessive amounts of alcohol.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Targretin - ako imate dokazanu preosjetljivost na retinoide (povezane s vitaminom A), bolujete od jetrene bolesti, imate visoke lipide u krvi ili uzimate lijekove koji mogu uzrokovati povišenje lipida u krvi, imate nekontroliranu šećernu bolest (dijabetes), imali ste bolest žučnog mjehura ili žučnih puteva ili konzumirate prekomjerne količine alkohola.
English: On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4, grapefruit juice may theoretically lead to an increase in plasma bexarotene concentrations.
Croatian: Na temelju oksidativnog metabolizma beksarotena putem citokroma P450 3A4, sok od grejpa može teoretski dovesti do povećanja koncentracije beksarotena u plazmi.
English: Laboratory test interactions CA125 assay values in patients with ovarian cancer may be accentuated with bexarotene therapy.
Croatian: Vrijednosti testa CA125 u bolesnica s karcinomom jajnika mogu biti izražene kod terapije beksarotenom.
English: The majority of adverse reactions were noted at a higher incidence at doses greater than 300 mg/m2/day.
Croatian: Većina nuspojava bila je zabilježena većom incidencijom pri dozama većima od 300 mg/m2 na dan.
English: Baseline thyroid function tests should be obtained and then monitored at least monthly during treatment and as indicated by the emergence of symptoms consistent with hypothyroidism.
Croatian: Potrebno je napraviti pretrage funkcije štitne žlijezde na početku, a potom ih pratiti barem jedanput mjesečno tijekom liječenja i u slučaju indikacije u obliku pojave simptoma sukladnih hipotireoidizmu.
English: Targretin capsules are used by patients with advanced stage cutaneous T-cell lymphoma (CTCL) whose disease has not responded to other therapies.
Croatian: Targretin kapsule uzimaju bolesnici s kožnim limfomom T-stanica u uznapredovalom stadiju, čija bolest nije reagirala na druge terapije.
English: Single doses of 1500 mg/kg (9000 mg/m 2) and 720 mg/kg (14,400 mg/m 2) were tolerated without significant toxicity in rats and dogs, respectively.
Croatian: 720 mg/kg (14 400 mg/m 2) bez značajne toksičnosti.
English: Data from clinical studies indicate that bexarotene concentrations were not affected by concomitant administration of atorvastatin.
Croatian: Podaci iz kliničkih ispitivanja pokazuju da na koncentracije beksarotena nije utjecala istodobna primjena atorvastatina.
English: Do not store above 30
Croatian: Ne čuvati na temperaturi iznad 30°C.
English: • phenytoin and phenobarbital (used against seizures),
Croatian: • fenitoin i fenobarbital (primjenjuju se protiv napadaja),
English: The estimated renal clearance of bexarotene is less than 1 ml/minute.
Croatian: Procijenjeni bubrežni klirens beksarotena iznosi manje od 1 ml/minuti.
English: Bexarotene therapy should only be initiated and maintained by physicians experienced in the treatment of patients with CTCL.
Croatian: Terapiju beksarotenom smiju započeti i provoditi samo liječnici s iskustvom u liječenju bolesnika s kožnim limfomom T-stanica (engl. cutaneous T-cell lymphoma, CTCL).
English: How to take Targretin
Croatian: Kako uzimati Targretin
English: No cases of hypoglycaemia associated with the use of bexarotene as monotherapy have been reported.
Croatian: Nije zabilježen nijedan slučaj hipoglikemije povezane s primjenom beksarotena kao monoterapije.
English: An adverse effect of long-term bexarotene treatment on cataract formation in humans has not been excluded.
Croatian: Nuspojava dugotrajnog liječenja beksarotenom na stvaranje katarakte u ljudi nije isključena.