natgillin/translations-raw huggingface dataset:
The effect of CE/BZA on the risk of stroke is unknown.
Vpliv CE/BZA na tveganje za možgansko kap ni znan.
Hepatic impairment
Ishemična možganska kap
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije periferni edem
• diabetes
• sladkorna bolezen;
• Hives (urticaria)
• koprivnica (urtikarija);
Migraine; headache; dizziness; nervousness
Bolezni živčevja migrena, glavobol, omotica, nervoznost poslabšanje epilepsije poslabšanje horeje
Reproductive system and breast disorders
Infekcijske in parazitske bolezni vulvovaginalna kandidoza
Talk to your doctor if you have any concerns.
Če imate kakršnekoli skrbi, se posvetujte z zdravnikom.
Hypromellose 2208 (100,000 mPa•s) (E464) Magnesium stearate
Jedro tablete s konjugiranimi estrogeni laktoza monohidrat mikrokristalna celuloza celuloza v prahu hipromeloza 2208 (100.000 mPa•s) (E464) magnezijev stearat kalcijev fosfat
Glucose intolerance;
• žolčni kamni;
Metabolism and nutrition disorders
Infekcijske in parazitske bolezni vaginitis
Speak to your doctor if you think this dose is too strong or not strong enough.
Če menite, da je odmerek premočan ali prešibek, se posvetujte z zdravnikom.
DUAVIVE (CE/BZA) has not been studied in the treatment of premature menopause.
Zdravljenja prezgodnje menopavze z zdravilom DUAVIVE (CE/BZA) niso raziskovali.
• Diarrhoea
• driska;
Bazedoxifene-5-glucuronide is the major circulating metabolite.
Znakov presnove prek sistema citokroma P450 je malo ali pa jih ni. Glavni presnovek v obtoku je bazedoksifen-5-glukuronid.
• Dizziness
• omotica;
STATEMENT OF ACTIVE SUBSTANCE(S)
Vsebnost pomožnih snovi
Calcium phosphate
Bolezni živčevja somnolenca
Risk ratio & 95%CI Additional cases per 1,000 HRT users over 5 years
Dodatni primeri na 1.000 uporabnic HNZ v obdobju 5 let
- CE/BZA must not be taken by women of childbearing potential, or breast-feeding women
- CE/BZA ne smejo jemati ženske v rodni dobi ali doječe matere (glejte poglavji 4.6
• Nausea (feeling sick)
• občutek siljenja na bruhanje (slabost);
Not known disorders
Preglednica neželenih učinkov
CE 0.45 mg/BZA 20 mg demonstrated similar changes in mammographic breast density compared to placebo over 1 year of treatment.
Po 1 letu zdravljenja so bile spremembe v gostoti dojk, ugotovljeni z mamografijo, podobne pri kombinaciji 0,45 mg CE/20 mg BZA in placebu.
Clear coating
PRETISNI OMOT
Breast density
Gostota dojk
The mechanism of this interaction is unknown.
Mehanizem tega medsebojnega delovanja ni znan.
The doctor will prescribe a suitable dose for you.
Zdravnik vam bo predpisal primeren odmerek.
Body Surface Area (m
Površina telesa (m
You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that this medicine could affect your mood and behaviour.
Določenih sprememb v razpoloženju in vedenju morda ne boste sami opazili, zato je zelo pomembno, da poveste svojim prijateljem in družini, da to zdravilo lahko vpliva na vaše razpoloženje in vedenje.
They may notice these changes and help you identify any problems that you need to talk to your doctor about.
Oni lahko te spremembe opazijo in vam pomagajo odkriti morebitne težave, o katerih bi se morali pogovoriti z zdravnikom.
Carcinogenicity studies have not been conducted.
Študije kancerogenosti niso bile izvedene.
Hypothyroidism generally occurs 4-8 weeks after commencement of therapy.
Hipotiroidizem se običajno pojavi 4-8 tednov po začetku terapije.
Contains sorbitol.
Vsebuje sorbitol.
This is important as using more than one medicine at the same time can strengthen or weaken the effect of the medicines.
To je zelo pomembno, saj lahko sočasno jemanje različnih zdravil učinek zdravil poveča ali oslabi.
60528 Frankfurt am Main Germany
60528 Frankfurt am Main Nemčija
Ongoing systemic infection.
Stalna sistemska infekcija.
The standard dose should be used in the elderly.
Pri starejših ljudeh je treba uporabiti običajni odmerek.
Bexarotene is not genotoxic.
Beksaroten ni genotoksičen.
Patients should be monitored for signs of depression and referred for appropriate treatment if necessary.
Bolnike je treba spremljati glede znakov depresije in jih po potrebi napotiti na ustrezno zdravljenje.
Do not take more than 15,000 International Units of vitamin A supplements per day during treatment.
Ne vzemite več kot 15.000 mednarodnih enot (i.e.) dodatka vitamina A dnevno v času zdravljenja.
The recommended dose is generally 4 to 10 capsules to be taken once daily.
Priporočeni odmerek je na splošno med 4 in 10 kapsulami enkrat dnevno.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
Treatment should be continued as long as the patient is deriving benefit.
Zdravljenje se mora nadaljevati, dokler je koristno za bolnika.
60528 Frankfurt am Main Germany e-mail: medinfo_de@eisai.net
60528 Frankfurt am Main Nemčija e-mail: medinfo_de@eisai.net
- if you have ever had any mental health problems including depression, aggressive tendencies or mood changes.
- če ste kadar koli imeli težave z duševnim zdravjem, vključno z depresijo, težnjami k agresivnemu vedenju ali spremembami v razpoloženju.
Sometimes it is necessary to adjust the dose or interrupt treatment.
Včasih je potrebno odmerek prilagoditi ali zdravljenje prekiniti.
Children and adolescents Targretin capsules should not be used in children or adolescents.
Otroci in mladostniki Targretin kapsule se ne smejo uporabljati za otroke ali mladostnike.
Tell your doctor if you are taking, have recently taken or might take any other medicines, such as
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, npr.
Although some patients have improvement within the first several weeks, most patients require several months or more of treatment to improve.
Čeprav se pri nekaterih bolnikih izboljšanje pojavi že po nekaj tednih, je za izboljšanje zdravstvenega stanja pri večini bolnikov potrebno večmesečno zdravljenje.
Whenever contraception is required, it is recommended that two reliable forms of contraception be used simultaneously.
Kadarkoli je potrebna kontracepcija, je priporočljivo, da se uporabita dve zanesljivi obliki kontracepcije hkrati.
The frequencies of adverse reactions are classified as very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), and very rare (<1/10,000).
Neželeni učinki so glede na pogostnost pojavljanja razvrščeni kot: zelo pogosti (> 1/10), pogosti (> 1/100, < 1/10), občasni (> 1/1.000, < 1/100), redki (> 1/10.000, < 1/1.000) in zelo redki (< 1/10.000).
Effects on fertility cannot be excluded.
Učinkov na plodnost ni mogoče izključiti.
Mental health problems
Težave z duševnim zdravjem
Date of first authorisation: 29 March 2001.
Datum prve odobritve: 29. marec 2001 Datum zadnjega podaljšanja: 24. april 2006
Targretin contains a small amount of sorbitol, therefore patients with rare hereditary problems of fructose intolerance should not take this medicine.
Targretin vsebuje majhno količino sorbitola, zato bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
System Organ Class (MedDRA terminology
Organski sistem (terminologija po MedDRA
The safety and efficacy of bexarotene in children (aged below 18 years) have not been established.
Varnost in učinkovitost beksarotena pri otrocih (mlajših od 18 let) še nista bili dokazani.
Name and address of the manufacturer responsible for batch release Eisai Manufacturing Limited
Ime in naslov izdelovalca, odgovornega za sproščanje serij Eisai Manufacturing Limited
Your doctor will advise you on what to do.
Zdravnik vam bo svetoval glede nadaljnjih ukrepov.
Once activated, these receptors function as transcription factors that regulate processes such as cellular differentiation and proliferation, apoptosis, and insulin sensitisation.
Ko so aktivirani, delujejo ti receptorji kot transkripcijski faktorji, ki regulirajo procese, kot so diferenciacija in proliferacija celic, apoptoza in inzulinska senzibilizacija.
Particular care should be taken in patients with a history of depression.
Posebna skrb je potrebna pri bolnikih z anamnezo depresije.
The aetiology of this finding is unknown.
Etiologija te ugotovitve preiskave ni znana.
Metabolism: bexarotene metabolites in plasma include 6- and 7-hydroxy-bexarotene and 6- and 7-oxo-bexarotene.
Metabolizem: Metaboliti beksarotena v plazmi vključujejo 6- in 7-hidroksi-beksaroten ter 6- in 7-okso-beksaroten.
If you are taking a hormonal contraceptive (for example, birth control pills), you should discuss this with your doctor.
Če jemljete hormonsko kontracepcijsko sredstvo (na primer kontracepcijske tablete), se morate posvetovati z zdravnikom.
DO NOT use Targretin if you are pregnant or breast-feeding.
NE jemljite Targretina, če ste noseči ali če dojite.
Of the total number of patients with CTCL in clinical studies, 61% were 60 years or older, while 30% were 70 years or older.
Od skupnega števila vseh bolnikov s CTCL, ki so sodelovali v kliničnih študijah, je bilo 61 % starih 60 let ali več ter 30 % 70 let ali več.
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.
Študije o plodnosti niso bile izvedene, vendar pa so pri spolno nezrelih psih samcih opazili reverzibilno aspermatogenezo (28-dnevna študija) ter testikularno degeneracijo (91-dnevna študija).
The use of some retinoids has been associated with photosensitivity.
Uporabo nekaterih retinoidov so povezali z občutljivostjo za svetlobo.
It is recommended that two reliable forms of contraception be used together.
Priporočamo, da uporabite dve zanesljivi obliki kontracepcije hkrati.
No formal studies have been conducted in patients with renal insufficiency.
Formalnih študij pri bolnikih z ledvično insuficienco niso izvajali.
This is because taking Targretin may affect your mood.
Jemanje zdravila Targretin namreč lahko vpliva na vaše razpoloženje.
Table 2 Adverse reactions reported in patients in clinical trials
Preglednica 2 Neželeni učinki, o katerih so poročali pri bolnikih v kliničnih preskušanjih
The uptake of bexarotene by organs or tissues has not been evaluated.
Absorbcija beksarotena s strani organov ali tkiva še ni bila analizirana.
Minimise exposure to sunlight as much as possible and avoid exposure to sun lamps.
Zmanjšajte izpostavljenost sončni svetlobi kolikor se da ter se ne izpostavljajte ultravijolični svetlobi (solariji).
Protein binding/distribution: bexarotene is highly bound (>99%) to plasma proteins.
Vezava/porazdelitev proteinov: Beksaroten se v veliki meri (> 99 %) veže na plazemske proteine.
Total daily dose (mg/day)
Celokupni dnevni odmerek (mg/dan)
When toxicity is controlled, doses may be carefully readjusted upward.
Pri kontrolirani toksičnosti se lahko odmerki ponovno previdno zvišajo.
The overall response rate according to this composite assessment was 31% (19/61) with a clinical complete response rate of 7% (4/61).
Celokupna stopnja odziva skladno s to sestavljeno oceno je bila 31 % (19/61) s celotnim kliničnim odzivom v višini 7 % (4/61).
Paediatric population Targretin is not recommended in children (aged below 18 years).
Pediatrična populacija Zdravilo Targretin ni priporočljivo pri otrocih (mlajših od 18 let).
Targretin is available as soft capsules for oral use in a white plastic bottle containing 100 capsules.
Targretin je na razpolago v obliki mehki kapsul za peroralno uporabo v beli plastenki, ki vsebuje 100 kapsul.
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).
Na osnovi primerjave izpostavljenosti beksarotenu pri živalih in pri bolnikih ni bila demonstrirana meja varnosti glede na teratogenost pri ljudeh (glejte poglavje 5.3).
If you regularly consume grapefruit or grapefruit juice, please consult your doctor as these have the potential to alter your body's response to Targretin therapy.
Če redno uživate grenivke ali grenivkin sok, se prosimo posvetujte z zdravnikom, ker lahko to vpliva na odziv vašega telesa na terapijo s Targretinom.
No overall differences in safety were observed between patients 70 years or older and younger patients, but greater sensitivity of some older individuals to bexarotene cannot be ruled out.
Glede na varnost zdravila niso opazili razlik med 70 let starimi bolniki oz. starejšimi in mlajšimi bolniki, sicer pa se večja občutljivost pri nekaterih starejših posameznih bolnikih ne da izključiti.
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.
Poleg tega so odzive določili na osnovi sestavljene ocene petih kliničnih znakov (površina, eritem, povečanje števila plakov, luskavica in hipo/hiperpigmentacija), ki so prav tako upoštevali vse zunajkožne CTCL manifestacije.
In male dogs, some effects have been documented (see section 5.3).
Pri samcih psov so ugotovili nekaj učinkov (glejte poglavje 5.3).
Do not stop taking your medication until your doctor advises you to do so.
Ne prenehajte jemati zdravila, dokler vam zdravnik ne bo dal ustreznih navodil.
Patients receiving bexarotene should not donate blood for transfusion.
Bolniki, ki dobivajo beksaroten, ne smejo darovati krvi.
Do not take Targretin:
Ne jemljite zdravila Targretin:
Based on the known mechanism of action, bexarotene may potentially enhance the action of these agents, resulting in hypoglycaemia.
Na osnovi znanega mehanizma delovanja lahko beksaroten potencialno poveča delovanje teh učinkovin ter posledično povzroči hipoglikemijo.
Initial dose calculations according to body surface area are as follows:
Začetni odmerek, ki je odvisen od površine telesa, se določi po sledeči shemi:
How long you should take Targretin
Kako dolgo morate jemati Targretin
However, dizziness and visual difficulties have been reported in patients taking Targretin.
Vendar pa so poročali o omotici in motnjah vida pri bolnikih, ki so jemali Targretin.
Excretion: neither bexarotene nor its metabolites are excreted in urine in any appreciable amounts.
Izločanje: Niti beksaroten niti njegovi metaboliti se ne izločajo s sečem v znatnih količinah.
There are indications that bexarotene may induce CYP3A4.
Obstajajo znaki, da beksaroten lahko povzroči indukcijo CYP3A4.
If you take more Targretin than you should If you have taken more than the prescribed dose of Targretin, you must contact your doctor.
Če ste vzeli večji odmerek zdravila Targretin, kot bi smeli Če ste vzeli večji odmerek, kot je predpisano, se morate posvetovati z zdravnikom.
Soft capsule.
Mehka kapsula
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.
Na osnovi podatkov iz tekočih kliničnih preskušanj se lahko povečane vrednosti pri testiranju jetrne funkcije (LFT) odpravijo v roku enega meseca pri 80% bolnikov, in sicer z zmanjšanjem odmerka ali s prekinitvijo terapije.
The capsules can be taken immediately before, during or immediately after the course of the meal, if preferred.
Kapsule lahko, po želji, vzamete neposredno pred ali med jedjo ali neposredno po jedi.
100 soft capsules
100 mehkih kapsul.
Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX25
Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX25
Other medicines and Targretin
Druga zdravila in zdravilo Targretin
When bexarotene was administered for six months to sexually mature dogs, no testicular effects were seen.
Ko je bil beksaroten dan spolno zrelim psom v časovnem obdobju šestih mesecev, niso opazili testikularnih učinkov.
If you forget to take one dose, take your daily dose with your next meal on the same day, then take your usual dose as normal, the following day.
Če ste pozabili vzeti en odmerek, vzemite dnevni odmerek skupaj z naslednjim obrokom istega dne.
Bexarotene is a synthetic compound that exerts its biological action through selective binding and activation of the three RXRs: , , and .
Beksaroten je sintetična spojina, ki svoj biološki način delovanja razvije na osnovi selektivne vezave in aktiviranja treh RXR: , in .
Bexarotene has a different adverse reaction profile to other oral, non-retinoid X receptor (RXR)-selective retinoids.
Beksaroten ima drugačen profil neželenih učinkov kot druga peroralna za ne-retinoidni X receptor (RXR, non-retinoid X receptor) - selektivna retinoidna zdravila.
Elevations of serum cholesterol should be managed according to current medical practice.
Zvišane vrednosti serumskega holesterola je treba uravnavati v skladu s trenutno prakso v zdravstvu.
Targretin contains sorbitol and butylated hydroxyanisole Targretin contains a small amount of sorbitol (a type of sugar).
Zdravilo Targretin vsebuje sorbitol in butilhidroksianizol Targretin vsebuje majhno količino sorbitola (vrsta sladkorja).
In vivo, bexarotene causes tumour regression in some animal models and prevents tumour induction in others.
In vivo, beksaroten povzroča regresijo tumorja pri nekaterih živalskih modelih ter preprečuje nastajanje tumorja pri drugih.
Bexarotene is contraindicated in pregnancy (see section 4.3).
Beksaroten je kontraindiciran med nosečnostjo (glejte poglavje 4.3).
However, the exact mechanism of action of bexarotene in the treatment of cutaneous T-cell lymphoma (CTCL) is unknown.
Vendar pa natančen mehanizem delovanja beksarotena pri zdravljenju kutanega T-celičnega limfoma (CTCL) ni znan.
There are no adequate data from the use of bexarotene in pregnant women.
Ni zadostnih podatkov o uporabi beksarotena pri nosečnicah.
Awareness by family or friends may be useful to detect mental health deterioration.
Pri zaznavanju poslabšanja duševnega zdravja je lahko dobrodošla pozornost družine ali prijateljev.
Periodic eye exams may be needed if you experience visual difficulties while taking this medicine.
Občasne preiskave oči so potrebne, če se pojavijo motnje vida v času jemanja tega zdravila.
Because safety and efficacy data from clinical trials are based upon administration with food, it is recommended that Targretin capsules be administered with food.
Ker podatki o varnosti in učinkovitosti temeljijo na kliničnih študijah, v katerih so bolniki zdravilo jemali pri jedi, je priporočljivo, da se Targretin kapsule zaužijejo skupaj s hrano.
CTCL is a condition in which certain cells of the body's lymph system called T-lymphocytes become cancerous and affect the skin.
CTCL je stanje, v katerem določene celice telesnega limfnega sistema, znane kot T-limfociti, postanejo rakaste in prizadenejo kožo.
The recommended initial dose is 300 mg/m 2/day.
Priporočen začetni odmerek je 300 mg/m 2/dan.
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 za tvorjenje heterodimerov z različnimi receptorskimi partnerji, ki so pomembni za celično delovanje in fiziologijo, kaže, da je biološko delovanje beksarotena bolj raznoliko v primerjavi s spojinami, ki aktivirajo RAR.
If you have an intolerance to some sugars, speak to your doctor before taking this medicinal product.
Če imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte z zdravnikom.
Gender has no statistically significant effect on bexarotene pharmacokinetics.
Spol ne vpliva statistično značilno na farmakokinetiko beksarotena.
Food interactions
Medsebojno delovanje s hrano
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 osnovi in vitro vezave in profila aktivacije retinoidnih receptorjev ter relativne količine posameznih metabolitov v plazmi imajo metaboliti le majhen vpliv na farmakološki profil aktiviranja retinoidnih receptorjev zaradi beksarotena.
Marketing Authorisation Holder Eisai GmbH
Imetnik dovoljenja za promet z zdravilom Eisai GmbH
The majority of cases resolved after dose reduction or discontinuation of treatment.
Večino primerov so uspešno odpravili z zmanjšanjem odmerka ali prekinitvijo zdravljenja.
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.
Spremembe pri testiranju delovanja ščitnice so opazili pri bolnikih, ki so jemali beksaroten, spremembe so bile najpogosteje vidne kot reverzibilna redukcija hormona ščitnice (skupni nivo tiroksina [skupno T4]) in tiroksin-stimulirajočega hormona (TSH).
In view of the limited data, patients with renal insufficiency should be monitored carefully while on bexarotene therapy.
Zaradi omejenih podatkov o bolnikih z ledvično insuficienco je treba le-te v času terapije z beksarotenom skrbno nadzorovati.
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.
Pri ponavljanju dajanja odmerka enkrat dnevno  230 mg/m2 sta bila Cmax in AUC pri nekaterih bolnikih nižja kot pri ustreznih vrednostih enkratnega odmerka.
Renal excretion is not a significant elimination pathway for bexarotene.
Izločanje preko ledvic ni pomembna pot izločanja za beksaroten.
• erythromycin, clarithromycin and rifampicin (used against bacterial infections),
• eritromicin, klaritromicin in rifampicin (za zdravljenje bakterijskih infekcij),
Bexarotene therapy should only be initiated and maintained by physicians experienced in the treatment of patients with CTCL.
Terapijo z beksarotenom naj predpiše in nadzoruje le zdravnik specialist, ki ima izkušnje z zdravljenjem bolnikov s CTCL.
Take your prescribed number of capsules at the same time each day with a meal.
Vzemite predpisano število kapsul vsak dan ob isti uri pri jedi.
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).
Od skupnega števila 810 bolnikov, ki so jih zdravili z beksarotenom, vključno s tistimi brez malignosti, so trije bolniki doživeli hude neželene učinke s smrtnim izidom (akutni pankreatitis, subduralni hematom in odpoved jeter).
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.
Iz tega razloga lahko večkratno dajanje beksarotena povzroči samoindukcijo lastnega metabolizma in (še posebej pri odmerkih, ki presegajo 300 mg/m2/dan) poveča stopnjo metabolizma ter zmanjša koncentracije drugih snovi v plazmi, katere presnavlja citokrom P450 3A4, kot je npr. tamoksifen.
In all clinical trials, patients were instructed to take Targretin capsules with or immediately following a meal.
V vseh kliničnih preskušanjih je bilo bolnikom dano navodilo, da vzamejo Targretin kapsule pri jedi oz. nemudoma po jedi.