natgillin/translations-raw huggingface dataset:
However, the exact mechanism of action of bexarotene in the treatment of cutaneous T-cell lymphoma (CTCL) is unknown. 
Međutim, točan mehanizam djelovanja beksarotena u liječenju kožnog limfoma T-stanica (CTCL) nije poznat.
There are insufficient data to evaluate potential differences in the pharmacokinetics of bexarotene for other races. 
Nema dovoljno podataka da bi se mogle procijeniti razlike u farmakokinetici beksarotena kod drugih rasa.
Particular care should be taken in patients with a history of depression. 
Potreban je poseban oprez u bolesnika s depresijom u anamnezi.
Elevation of blood fats (triglycerides and cholesterol). 
Povišenje masnoća u krvi (triglicerida i kolesterola).
High-density polyethylene bottles with child-resistant closures containing 100 capsules. 
Bočice od polietilena visoke gustoće sa sigurnosnim zatvaračem za djecu koje sadrže 100 kapsula.
Thus, if treatment with bexarotene is intended in a woman with childbearing potential, a reliable, non-hormonal contraceptive method is also recommended. 
Stoga, ako se planira liječenje beksarotenom u žene reproduktivne dobi, preporučuje se i pouzdana, nehormonska metoda kontracepcije.
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. 
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.
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. 
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.
Pregnancy and lactation. 
Trudnoća i dojenje.
With appropriate clinical monitoring, individual patients may benefit from doses above 300 mg/m 2/day. 
Uz odgovarajući klinički nadzor, pojedini bolesnici mogu imati koristi i od doza viših od 300 mg/m2 na dan.
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). 
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).
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. 
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.
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. 
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.
• tamoxifen (used against some forms of cancer), 
• tamoksifen (primjenjuje se protiv nekih oblika raka),
• erythromycin, clarithromycin and rifampicin (used against bacterial infections), 
• eritromicin, klaritromicin i rifampicin (primjenjuju se protiv bakterijskih infekcija),
Off-white capsule, containing a liquid suspension and imprinted with “Targretin”. 
Gotovo bijela kapsula koja sadrži tekuću suspenziju i otisnutu oznaku “Targretin”.
Targretin capsules should be used with caution in patients with a known hypersensitivity to retinoids. 
Targretin kapsule treba primjenjivati s oprezom u bolesnika s poznatom preosjetljivošću na retinoide.
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. 
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.
If you experience dizziness or problems with your vision during therapy, do not drive or operate machinery. 
Ako osjetite omaglicu ili tegobe s vidom tijekom terapije, nemojte upravljati vozilima niti raditi sa strojevima.
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). 
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).
If you have an intolerance to some sugars, speak to your doctor before taking this medicinal product. 
Ako ne podnosite neke šećere, obratite se liječniku prije nego što uzmete ovaj lijek.
Doses greater than 650 mg/m 2/day have not been evaluated in patients with CTCL. 
Doze veće od 650 mg/m2 na dan nisu ispitane u bolesnika s CTCL.
The recommended initial dose is 300 mg/m 2/day. 
Preporučena početna doza je 300 mg/m 2 na dan.
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. 
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.
Table 1 Recommended initial dose Initial dose level (300 mg/m2/day) 
Tablica 1 Preporučena početna doza Razina početne doze (300 mg/m2 na dan)
How long you should take Targretin 
Koliko dugo trebate uzimati Targretin
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. 
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.
If you take more Targretin than you should If you have taken more than the prescribed dose of Targretin, you must contact your doctor. 
Ako ste uzeli više od propisane doze Targretin, morate se obratiti liječniku.
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. 
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.
For example bexarotene may reduce the efficacy of oral contraceptives (see sections 4.4 and 4.6). 
Na primjer, beksaroten može smanjiti djelotvornost oralnih kontraceptiva (vidjeti dijelove 4.4 i
What you need to know before you take Targretin 
Što morate znati prije nego počnete uzimati Targretin
Doses up to 1000 mg/m 2/day of bexarotene have been administered in clinical studies with no acute toxic effects. 
Doze beksarotena do 1000 mg/m 2 na dan primijenjene su u kliničkim ispitivanjima bez akutnih toksičnih učinaka.
At the recommended initial daily-dose level (300 mg/m2), single-dose and repeated daily-dose bexarotene pharmacokinetic parameters were similar. 
Na razini preporučene početne dnevne doze (300 mg/m2), farmakokinetički parametri beksarotena nakon jednokratne primjene i ponovljene dnevne doze bili su slični.
Bexarotene has a different adverse reaction profile to other oral, non-retinoid X receptor (RXR)-selective retinoids. 
Beksaroten ima različit profil nuspojava od drugih peroralnih retinoida koji nisu selektivni za retinoidni X receptor (RXR).
The capsules also contain the other ingredients macrogol, polysorbate, povidone and butylated hydroxyanisole. 
Kapsule također sadrže druge sastojke kao što su makrogol, polisorbat, povidon i butilhidroksianizol.
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. 
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.
Proteins in urine, abnormal kidney function. 
Proteini u mokraći, abnormalna funkcija bubrega.
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. 
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.
Patients who experience dizziness or visual difficulties during therapy must not drive or operate machinery. 
Bolesnici koji osjete omaglicu ili poteškoće s vidom tijekom terapije ne smiju upravljati vozilima niti raditi sa strojevima.
In clinical trials, bexarotene was administered for up to 118 weeks to patients with CTCL. 
U kliničkim ispitivanjima, beksaroten se primjenjivao do 118 tjedana bolesnicima s CTCL.
No formal studies to evaluate interactions with bexarotene have been conducted. 
Nisu provedena službena ispitivanja procjene interakcija s beksarotenom.
Uncommon (can occur in up to 1 in 100 patients treated): 
Manje često (mogu nastati u do 1 na 100 liječenih bolesnika):
In all evaluated patients, the estimated renal clearance of bexarotene was less than 1 ml/minute. 
U svih ispitanih bolesnika, procijenjeni klirens beksarotena bio je manji od 1 ml/minuti.
You must use effective contraception (birth control) continuously starting one month before beginning therapy until one month after you stop taking Targretin. 
Morate neprekidno koristiti učinkovitu kontracepciju (metodu kontrole začeća) počevši mjesec dana prije početka terapije pa sve do mjesec dana nakon prestanka uzimanja Targretina.
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. 
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).
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. 
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.
Any patient treated with bexarotene who experiences visual difficulties should have an appropriate ophthalmologic examination. 
Svakog bolesnika liječenog beksarotenom koji opazi poteškoće s vidom treba primjereno oftalmološki pregledati.
• vitamin A supplements, protease inhibitors (used against viral infections), 
• nadomjesci vitamina A, inhibitori proteaze (primjenjuju se protiv virusnih infekcija),
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. 
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.
Headache, fatigue, pain. 
Glavobolja, umor, bol.
Bexarotene capsules were evaluated in clinical trials of 193 patients with CTCL of whom 93 had advanced stage disease refractory to prior systemic therapy. 
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.
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. 
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.
In vitro, bexarotene inhibits the growth of tumour cell lines of haematopoietic and squamous cell origin. 
In vitro, beksaroten inhibira rast tumorskih staničnih linija koje potječu od hematopoetskih i skvamoznih stanica.
No clinical instances of cross-reactivity have been noted. 
Nisu primijećeni klinički slučajevi križne preosjetljivosti.
CTCL is a condition in which certain cells of the body's lymph system called T-lymphocytes become cancerous and affect the skin. 
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.
The capsules should be swallowed whole and not chewed. 
Kapsule se moraju progutati cijele i bez žvakanja.
• ketoconazole and itraconazole (used against fungal infections), 
• ketokonazol i itrakonazol (primjenjuju se protiv gljivičnih infekcija),
Capsule content: macrogol polysorbate povidone butylated hydroxyanisole 
Sadržaj kapsule: makrogol polisorbat povidon butilhidroksianizol
Clinical pharmacokinetic data indicate that urinary elimination of bexarotene and its metabolites is a minor excretory pathway for bexarotene. 
Klinički farmakokinetički podaci pokazuju da je eliminacija beksarotena i njegovih metabolita putem mokraće manji put izlučivanja beksarotena.
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. 
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.
It may be asymptomatic and responds to treatment with thyroxine and resolves upon withdrawal of treatment. 
Može biti asimptomatski i odgovara na liječenje tiroksinom te se povlači nakon prestanka liječenja.
No clinical experience with an overdose of Targretin has been reported. 
Nema zabilježenog kliničkog iskustva s preodoziranjem lijekom Targretin.
Elevation of liver enzymes, impaired kidney function, low protein in blood, weight gain. 
Povišenje jetrenih enzima, narušena funkcija bubrega, niski proteini u krvi, povećanje tjelesne težine.
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. 
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).
Uncontrolled hypercholesterolaemia. 
Nekontrolirana hiperkolesterolemija.
No formal studies have been conducted in patients with renal insufficiency. 
Nisu provedena službena ispitivanja u bolesnika s insuficijencijom bubrega.
Elevated bilirubin in the blood, impaired kidney function, gout, decreased HDL cholesterol. 
Povišen bilirubin u krvi, oštećena funkcija bubrega, giht, snižen HDL kolesterol.
Patients with diabetes mellitus 
Bolesnici s dijabetesom melitusom
There are no human data on the effect of bexarotene on fertility. 
Nema podataka za ljude o učinku beksarotena na plodnost.
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. 
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.
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. 
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.
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. 
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.
Chills, abdominal pain, allergic reaction, infection. 
Zimice, bol u trbuhu, alergijska reakcija, infekcija.
Renal excretion is not a significant elimination pathway for bexarotene. 
Bubrežno izlučivanje nije značajan put eliminacije beksarotena.
Blood disorders, eosinophilia, leukocytosis, lymphocytosis, purpura, elevated and decreased numbers of blood platelets. 
Poremećaji krvi, eozinofilija, leukocitoza, limfocitoza, purpura, povišeni i sniženi broj krvnih pločica.
Bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestive contraceptives. 
Beksaroten može potencijalno inducirati metaboličke enzime i tako teoretski smanjiti djelotvornost estrogensko-progestagenske kontracepcije.
Elevations of serum cholesterol should be managed according to current medical practice. 
Povišenja serumskog kolesterola treba liječiti sukladno važećoj medicinskoj praksi.
Lowering of thyroid hormones level. 
Sniženje razine hormona štitne žlijezde.
There are no adequate data from the use of bexarotene in pregnant women. 
Nema odgovarajućih podataka o primjeni beksarotena u trudnica.
Effects of other substances on bexarotene 
Učinci drugih tvari na beksaroten
Women of childbearing potential must use adequate birth-control measures when bexarotene is used. 
Žene reproduktivne dobi moraju primjenjivati odgovarajuće mjere kontrole začeća kad uzimaju beksaroten.
Concomitant administration of gemfibrozil with bexarotene is not recommended. 
Ne preporučuje se istodobna primjena gemfibrozila s beksarotenom.
Bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestative contraceptives (see section 4.5). 
Beksaroten može potencijalno inducirati metaboličke enzime i tako teoretski smanjiti djelotvornost estrogensko-progestagenske kontracepcije (vidjeti dio 4.5).
If you stop taking Targretin 
Ako prestanete uzimati Targretin
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 
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%).
Agitation, difficulties with balance, depression, increased skin sensation on touching, abnormal nerve sensations, vertigo. 
Uznemirenost, poteškoće s ravnotežom, depresija, pojačan osjet dodira na koži, abnormalni živčani osjeti, vrtoglavica.
Swelling, bleeding, high blood pressure, fast heart rate, visible vein enlargement, dilation of blood vessels. 
Oticanje, krvarenje, povišen krvni tlak, ubrzan rad srca, vidljivo povećanje vena, proširenje krvnih žila.
Women of child-bearing potential without effective birth-control measures. 
Žene reproduktivne dobi koje ne koriste učinkovite mjere kontrole začeća.
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. 
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.
Effects of bexarotene on other substances 
Učinci beksarotena na druge tvari
Skin reactions (Itching, redness, irritation, peeling). 
Kožne reakcije (svrbež, crvenilo, nadraženost, ljuštenje).
Generally, these resolved without sequelae on dose reduction or withdrawal of treatment. 
Općenito, ove su se nuspojave povukle bez posljedica na sniženje doze ili prekid liječenja.
Dry eyes, deafness, abnormal sensations of the eye including irritation and heaviness. 
Suhe oči, gluhoća, abnormalni osjeti u oku uključujući nadraženost i težinu.
Race: Based on the population pharmacokinetic analysis of data for 540 Caucasian and 44 Black patients, bexarotene pharmacokinetics are similar in Blacks and Caucasians. 
Rasa: Na temelju populacijske farmakokinetičke analize podataka za 540 bijelaca i 44 crnca, bijelci i crnci imaju sličnu farmakokinetiku beksarotena.
If you forget to take Targretin 
Ako ste zaboravili uzeti Targretin
Patients with symptomatic hypothyroidism on bexarotene therapy have been treated with thyroid hormone supplements with resolution of symptoms. 
Bolesnici sa simptomatskim hipotireoidizmom na terapiji beksarotenom liječeni su nadomjescima hormona štitne žlijezde uz povlačenje simptoma.
Butylated hydroxyanisole, an ingredient in Targretin, may cause irritation to the mucous membranes, therefore the capsules must be swallowed intact and not chewed. 
Butilhidroksianizol, sastojak u Targretinu, može prouzročiti nadraženost sluznica pa se stoga kapsule moraju progutati cijele i ne smiju se žvakati.
Fasting triglycerides should be normal or normalised with appropriate intervention prior to bexarotene therapy. 
Prije terapije beksarotenom, trigliceridi natašte trebaju biti normalni ili normalizirani odgovarajućom intervencijom.
Targretin contains sorbitol and butylated hydroxyanisole Targretin contains a small amount of sorbitol (a type of sugar). 
Targretin sadrži malu količinu sorbitola (vrsta šećera).