FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Farmakokinetika pri posebnih skupinah bolnikov Starost: na podlagi populacijske farmakokinetične analize podatkov za 232 bolnikov, starih ≥ 65 let, in 343 bolnikov, starih < 65 let, starost ne vpliva statistično značilno na farmakokinetiko beksarotena.
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.
Slovenian: Populacijska analiza plazemskih koncentracij beksarotena pri bolnikih s CTCL kaže, da je sočasno dajanje gemfibrozila povzročilo bistveno povečanje koncentracije beksarotena v plazmi.
English: Dose modification guidelines The 300 mg/m 2/day dose level may be adjusted to 200 mg/m 2/day then to 100 mg/m 2/day, or temporarily suspended, if necessitated by toxicity.
Slovenian: Odmerek v višini 300 mg/m 2/dan se lahko zmanjša na 200 mg/m 2/dan in nato na 100 mg/m 2/dan oz. zdravljenje se lahko začasno prekine, če je to potrebno zaradi toksičnosti.
English: Patients who experience dizziness or visual difficulties during therapy must not drive or operate machinery.
Slovenian: Bolniki, pri katerih se pojavijo omotice ali motnje vida med terapijo, ne smejo voziti ali upravljati strojev.
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.
Slovenian: Med kliničnimi študijami so poročali o sledečih neželenih učinkih pri bolnikih s CTCL (N=109), ki so se zdravili s priporočenim začetnim odmerkom 300 mg/m2/dan.
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%.
Slovenian: Pri 61 bolnikih, ki so dobivali začetni odmerek 300 mg/m2/dan, je bila skupna stopnja odziva po globalni oceni zdravnika 51 % (31/61).
English: Vitamin A supplementation
Slovenian: Vitaminski dodatki - Vitamin A
English: Doses greater than 650 mg/m 2/day have not been evaluated in patients with CTCL.
Slovenian: Odmerki, ki presegajo 650 mg/m2/dan, še niso bili preučevani pri CTCL bolnikih.
English: The estimated renal clearance of bexarotene is less than 1 ml/minute.
Slovenian: Ocenjeno čiščenje beksarotena preko ledvic je ocenjeno na manj kot 1 ml/minuta.
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.
Slovenian: Če se potemtakem plodne ženske nameravajo zdraviti z beksarotenom, je potrebna zanesljiva, nehormonska oblika kontracepcije, saj spada beksaroten v terapevtsko skupino, pri kateri obstaja veliko tveganje za razvojne nepravilnosti zarodka.
English: Capsule content: macrogol polysorbate povidone butylated hydroxyanisole
Slovenian: Kapsula vsebuje: makrogol polisorbat povidon butilhidroksianizol
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.
Slovenian: Varnost beksarotena so analizirali v kliničnih študijah s 193 bolniki s CTCL, ki so dobivali beksaroten v času do 118 tednov ter v drugih študijah, v katerih je sodelovalo 420 bolnikov brez CTCL-a.
English: The capsule should not be chewed.
Slovenian: Kapsul ni dovoljeno žvečiti.
English: Any overdose should be treated with supportive care for the signs and symptoms exhibited by the patient.
Slovenian: Morebitno preveliko odmerjanje je treba zdraviti s pomožno terapijo, ki je odvisna od znakov in simptomov bolnika.
English: Oral contraceptives
Slovenian: Peroralna kontracepcijska sredstva
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.
Slovenian: In vitro raziskave nakazujejo glukuronidacijo kot metabolno pot, ter da je citokrom P450 3A4 glavni izoencim citokroma P450, ki je odgovoren za tvorjenje oksidativnih metabolitov.
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.
Slovenian: Bolnike je treba obvestiti, da morajo zmanjšati izpostavljenost sončni svetlobi ter ultravijolični svetlobi (solarij) kolikor se da, ker in vitro podatki kažejo na to, da beksaroten lahko povzroča preobčutljivost na svetlobo.
English: There are no human data on the effect of bexarotene on fertility.
Slovenian: Pri ljudeh ni podatkov o učinku beksarotena na plodnost.
English: If you experience dizziness or problems with your vision during therapy, do not drive or operate machinery.
Slovenian: Če v času terapije postanete omotični ali če se pojavijo motnje vida, ne vozite in ne upravljajte s stroji.
English: For example bexarotene may reduce the efficacy of oral contraceptives (see sections 4.4 and 4.6).
Slovenian: Beksaroten lahko na primer zmanjša učinkovitost peroralnih kontracepcijskih sredstev (glejte poglavje 4.4 in
English: It is unknown whether bexarotene is excreted in human milk.
Slovenian: Ni znano, ali se beksaroten izloča v materino mleko.
English: What Targretin looks like and contents of the pack
Slovenian: Izgled zdravila Targretin in vsebina pakiranja
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.
Slovenian: Kot večina retinoidov je tudi beksaroten v poskusih na živalih pokazal teratogenost in embriotoksičnost pri sistemskih izpostavljenostih, ki se lahko klinično dosežejo tudi pri ljudeh.
English: Clinical pharmacokinetic data indicate that urinary elimination of bexarotene and its metabolites is a minor excretory pathway for bexarotene.
Slovenian: Klinični farmakokintečni podatki kažejo, da izločanje beksarotena in njegovih metabolitov s sečem predstavlja le manjši del izločanja beksarotena.
English: What you need to know before you take Targretin
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Targretin
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.
Slovenian: Beksaroten kapsule so ovrednotili v kliničnih preskušanjih, v katerih je sodelovalo 193 bolnikov s CTCL, od katerih je 93 bolnikov imelo bolezen v razvitem stadiju in se ni odzvalo na predhodno sistemsko terapijo.
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.
Slovenian: Če ste moški in če je vaša partnerica noseča oz. če lahko zanosi, morate v času jemanja beksarotena med spolnim odnosom uporabiti kondome, in sicer najmanj za čas enega meseca po zadnjem odmerku.
English: The capsules should be swallowed whole and not chewed.
Slovenian: Kapsule morate pogoltniti cele in jih ne smete žvečiti.
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.
Slovenian: V eni klinični študiji so bile vrednosti beksarotena AUC in Cmaks v plazmi po jedi, ki je bila bogata z maščobo, bistveno višje v primerjavi z vrednostmi, merjenimi po dajanju raztopine glukoze.
English: The majority of adverse reactions were noted at a higher incidence at doses greater than 300 mg/m2/day.
Slovenian: Večina neželenih učinkov se je pojavila pogosteje pri odmerkih višjih od 300 mg/m2/dan.
English: Your doctor should determine how long you should take Targretin, and when treatment may be stopped.
Slovenian: Če ste prenehali jemati zdravilo Targretin Vaš zdravnik bo določil, kako dolgo boste morali jemati zdravilo Targretin in kdaj boste zdravljenje lahko prekinili.
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):
Slovenian: Dodatna opažanja neželenih učinkov pri uporabi izven priporočenega obsega odmerkov ali za druge indikacije (npr. uporaba pri CCTL z začetnim odmerkom >300 mg/m2/dan ali za indikacije, ki niso CTCL):
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.
Slovenian: Pri nekaterih bolnikih so po zdravljenju z beksarotenom opazili poprej neopažene motnosti očesne leče oz. spremembe že obstoječe motnosti očesne leče, ki pa niso bile povezane s trajanjem zdravljenja ali višino odmerka.
English: Because of the relationship of bexarotene to vitamin A, patients should be advised to limit vitamin A supplements to 15,000 IU/day to avoid potential additive toxic effects.
Slovenian: Zaradi sorodnosti beksarotena in vitamina A morajo biti bolniki obveščeni, da vitaminske dodatke vitamina A omejijo na  15.000 i.e./dan.
English: Targretin should be taken with food (see section 3).
Slovenian: Zdravilo Targretin skupaj s hrano in pijačo Targretin vzemite pri jedi (glejte poglavje 3).
English: If you forget to take Targretin
Slovenian: Če ste pozabili vzeti zdravilo Targretin
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.
Slovenian: Teden pred začetkom terapije je treba opraviti občutljiv test za ugotavljanje nosečnosti (npr. serumski beta-humani horionski gonadotropin, beta-HCG), ki mora biti negativen.
English: Rare fatal side effects are acute inflammation of the pancreas, bleeding in the head, and liver failure.
Slovenian: Redki življenjsko nevarni neželeni učinki so akutno vnetje pankreasa, krvavitve v glavi in odpoved jeter.
English: In all evaluated patients, the estimated renal clearance of bexarotene was less than 1 ml/minute.
Slovenian: Pri vseh pregledanih bolnikih je bilo ocenjeno izločanje beksarotena preko ledvic manjše kot 1 ml/minuta.
English: Bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestative contraceptives (see section 4.5).
Slovenian: Beksaroten lahko potencialno inducira metabolične encime in na ta način zmanjša učinkovitost estroprogestativnih kontracepcijskih sredstev (glejte poglavje 4.5).
English: Uncontrolled hypercholesterolaemia.
Slovenian: Nekontrolirana hiperholesterolemija.
English: Hepatic insufficiency.
Slovenian: Jetrna insuficienca.
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
Slovenian: 109 bolnikov s CTCL, zdravljenih s priporočenim začetnim odmerkom 300 mg/m2/dan, je najpogosteje poročalo o sledečih neželenih učinkih: hiperlipemija ((na začetku zvišani trigliceridi) 74 %), hipotiroidizem (29 %), hiperholesterolemija (28 %), glavobol (27 %), levkopenija (20 %), pruritus (20 %), astenija (19 %), izpuščaji (16 %), eksfoliativni dermatitis (15 %) in bolečina (12 %).
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.
Slovenian: Moški bolniki s spolno partnerico, ki je noseča, eventualno noseča oz. lahko zanosi, morajo za koitus uporabiti kondom v času jemanja beksarotena, in sicer za čas najmanj enega meseca po zadnjem odmerku.
English: • insulin, agents enhancing insulin secretion, or insulin-sensitisers (used against diabetes mellitus).
Slovenian: • insulin, zdravila, ki zvečajo sekrecijo insulina, ali zdravila, ki zvečajo občutljivost za insulin (uporabljajo se pri sladkorni bolezni).
English: • ketoconazole and itraconazole (used against fungal infections),
Slovenian: • ketokonazol in itrakonazol (za zdravljenje glivičnih obolenj),
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.
Slovenian: Zdravilo Targretin je namenjeno zdravljenju kožnih manifestacij pri odraslih bolnikih s kožnim T-celičnim limfomom (CTCL - cutaneous T-cell lymphoma) v razvitem stadiju, ki se ni odzval na najmanj eno sistemsko zdravljenje.
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.
Slovenian: Zaradi visoke frekvence pojava ter naravnega nivoja nastanka očesne mrene pri skupini starejših bolnikov, ki je sodelovala v kliničnih študijah, ni bila ugotovljena povezanost med pogostostjo pojava motnosti očesne leče in dajanjem beksarotena.
English: Liver Function Test (LFT) abnormalities
Slovenian: Anomalije pri testiranju jetrne funkcije (LFT)
English: Table 1 Recommended initial dose Initial dose level (300 mg/m2/day)
Slovenian: Priporočeni začetni odmerek Višina začetnega odmerka (300 mg/m2/dan)
English: An adverse effect of long-term bexarotene treatment on cataract formation in humans has not been excluded.
Slovenian: Neželene učinke pri dolgoročnem zdravljenju z beksarotenom glede na nastanek katarakt pri ljudeh niso izključili.
English: It is not known whether Targretin has an effect on your ability to drive a car or operate machinery.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni znano, ali Targretin vpliva na sposobnost upravljanja vozil in strojev.
English: Targretin capsules are used by patients with advanced stage cutaneous T-cell lymphoma (CTCL) whose disease has not responded to other therapies.
Slovenian: Targretin kapsule so namenjene bolnikom s subkutanim T-celičnim limfomom (CTCL) v razvitem stadiju, katerih bolezen se ni odzvala na druge terapije.
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.
Slovenian: Na osnovi svoje primarne RXR-vezavne aktivnosti je manj verjetno, da beksaroten povzroča mukokutano toksičnost ali toksičnost za nohte in lase, artralgijo in mialgijo, katerih pojav je pogost pri učinkovinah, ki se vežejo na receptorje retinojske kisline (RAR, retinoic acid receptor).
English: Effects of bexarotene on other substances
Slovenian: Učinki beksarotena na druge snovi
English: In clinical trials, bexarotene was administered for up to 118 weeks to patients with CTCL.
Slovenian: V kliničnih preskušanjih so bolniki s CTCL do 118 tednov prejemali beksaroten.
English: Do not take a double dose in one day to make up for a forgotten dose the previous day.
Slovenian: Nato pa nadaljujte z običajnim odmerkom naslednji dan. Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: No clinical instances of cross-reactivity have been noted.
Slovenian: O navzkrižnih reakcijah v kliničnih primerih niso poročali.
English: Patients with symptomatic hypothyroidism on bexarotene therapy have been treated with thyroid hormone supplements with resolution of symptoms.
Slovenian: Bolnikom s simptomatičnimi znaki hipotiroidizma v času terapije z beksarotenom so odpravili simptome s komplementarnimi sredstvi za hormon ščitnice.
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.
Slovenian: Če lahko zanosite, morate teden dni pred začetkom terapije opraviti test za ugotavljanje nosečnosti, ki mora biti negativen.
English: No evidence of prolonged accumulation was observed.
Slovenian: Znake dolgoročnega kopičenja niso opazili.
English: Any patient treated with bexarotene who experiences visual difficulties should have an appropriate ophthalmologic examination.
Slovenian: Bolniki, ki se zdravijo z beksarotenom ter opazijo težave z očmi, morajo opraviti oftalmološki pregled.
English: Baseline LFTs should be obtained, and LFTs should be carefully monitored weekly during the first month and then monthly thereafter.
Slovenian: Potrebna je določitev temeljnih vrednosti pri testiranju jetrne funkcije (Baseline LFTs), ki pa jih je treba skrbno spremljati tedensko v prvem mesecu in nato vsaj enkrat na mesec.
English: With appropriate clinical monitoring, individual patients may benefit from doses above 300 mg/m 2/day.
Slovenian: Pri ustreznem kliničnem spremljanju lahko odmerki nad 300 mg/m 2/dan ugodno vplivajo na posamezne bolnike.
English: Thus, if treatment with bexarotene is intended in a woman with childbearing potential, a reliable, non-hormonal contraceptive method is also recommended.
Slovenian: Če se potemtakem plodne ženske nameravajo zdraviti z beksarotenom, je potrebna dodatna, nehormonska oblika kontracepcije.
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.
Slovenian: Na osnovi oksidativne presnove beksarotena zaradi citokroma P450 3A4 lahko sok grenivke teoretično povzroči povečanje koncentracije beksarotena v plazmi.
English: Laboratory test interactions CA125 assay values in patients with ovarian cancer may be accentuated with bexarotene therapy.
Slovenian: Vpliv na laboratorijske preiskave - medsebojno delovanje Vrednosti CA125 v testih pri bolnikih z rakom jajčnikov so lahko izrazitejše.
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.
Slovenian: Na osnovi oksidativnega metabolizma beksarotena zaradi citokroma P450 3A4 (CYP3A4) vodi sočasna uporaba CYP3A4 substratov, kot so ketokonazol, itrakonazol, proteazni inhibitorji, klaritromicin in eritromicin, teoretično do povečanja koncentracije beksarotena v plazmi.
English: • phenytoin and phenobarbital (used against seizures),
Slovenian: • fenitoin in fenobarbital (za zdravljenje napadov),
English: Butylated hydroxyanisole, an ingredient in Targretin, may cause irritation to the mucous membranes, therefore the capsules must be swallowed intact and not chewed.
Slovenian: Butilhidroksianizol, sestavina zdravila Targretin, lahko draži sluznice, zato morate kapsule pogoltniti cele in jih ne smete žvečiti.
English: Concomitant administration of gemfibrozil with bexarotene is not recommended.
Slovenian: Sočasno dajanje gemfibrozila pri terapiji z beksarotenom ni priporočljivo.
English: Uncontrolled hypertriglyceridaemia.
Slovenian: Nekontrolirana hipertrigliceridemija.
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.
Slovenian: Pred začetkom jemanja zdravila bo morda potrebno določiti vaše krvne lipide (na tešče), nato pa tedensko in pozneje enkrat na mesec v času jemanja zdravila.
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.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Targretin se posvetujte z zdravnikom - če imate znano preobčutljivost za retinoide (sorodni vitaminu A), če ste bolni na jetrih, če imate visoke vrednosti krvnih lipidov ali če jemljete zdravila, ki lahko povečajo vrednosti krvnih lipidov, če imate nekontroliran diabetes mellitus (sladkorno bolezen), če ste bili bolni na žolčniku ali žolčevodu ali če uživate prekomerne količine alkohola.
English: Targretin capsules should be taken as a single oral daily dose with a meal.
Slovenian: Kapsule zdravila Targretin naj se jemljejo enkrat dnevno peroralno pri jedi.
English: OUTER CARTON TEXT AND BOTTLE LABEL TEXT
Slovenian: BESEDILO NA ZUNANJI OVOJNINI IN NALEPKI PLASTENKE
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.
Slovenian: V primeru, da so trigliceridi (na tešče) zvišani ali če se vrednost trigliceridov v času zdravljenja poveča, je priporočena antilipidna terapija ali po potrebi tudi zmanjšanje odmerka (iz 300 mg/m2/dan beksarotena na
English: Bexarotene may potentially enhance the action of insulin, agents enhancing insulin secretion (e.g. sulfonylureas), or insulin-sensitisers (e.g. thiazolidinediones), resulting in hypoglycaemia (see section
Slovenian: Beksaroten lahko zveča delovanje insulina, učinkovin, ki zvečajo izločanje insulina (npr. sulfonilurej) ali učinkovin, ki zvečajo občutljivost za insulin (npr. tiazolidindionov), kar ima za posledico hipoglikemijo (glejte poglavje 4.4).
English: Data from clinical studies indicate that bexarotene concentrations were not affected by concomitant administration of atorvastatin.
Slovenian: Podatki iz kliničnih študij kažejo, da sočasno dajanje atorvastatina ni imelo vpliva na koncentracije beksarotena.
English: Photosensitivity
Slovenian: Občutljivost za svetlobo
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.
Slovenian: Od trenutka negativnega testa za ugotavljanje nosečnosti do začetka terapije, v času terapije ter za čas najmanj enega meseca po prenehanju terapije, morajo bolníce poskrbeti za učinkovito kontracepcijo.
English: Absorption/dose proportionality: pharmacokinetics were linear up to a dose of 650 mg/m2.
Slovenian: Absorpcija/sorazmernost odmerka: Farmakokinetika je bila linearna do odmerka 650 mg/m Razpolovna doba končnega izločanja je bila običajno med eno in tremi urami.
English: Patients with renal impairment
Slovenian: Bolniki z ledvičnimi okvarami
English: Women of child-bearing potential without effective birth-control measures.
Slovenian: Plodne ženske, ki ne uporabljajo učinkovitih kontracepcijskih sredstev.
English: Uncontrolled thyroid disease.
Slovenian: Nekontrolirane bolezni ščitnice.
English: Ataxia Neuropathy Vertigo Hyperaesthesia Depression Agitation
Slovenian: Omotica Hipestezija nespečnost ataksija nevropatija vrtoglavica hiperestezija depresija agitacija