FrancophonIA/ELRC3.0 huggingface dataset:
English: For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period.
Slovenian: Na primer pri ženskah, starih od 50 do 54 let, ki ne uporabljajo HNZ, bodo v obdobju 5 let pri približno 2 ženskah izmed 2.000 odkrili raka jajčnikov.
English: • you notice signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, or difficulty in breathing.
Slovenian: • če opazite znake krvnega strdka, kot so boleče otekanje in rdečica nog, nenadna bolečina v prsnem košu ali težko dihanje.
English: After opening the blister pouch, use within 60 days.
Slovenian: Uporabite v 60 dneh po odprtju zaščitnega ovoja s pretisnim omotom.
English: - Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels (by radio-immunoassay).
Slovenian: - Estrogeni zvečajo koncentracijo globulina, ki veže ščitnične hormone (TBG - thyroid binding globulin), in tako zvišajo raven celotne količine ščitničnih hormonov v krvnem obtoku, merjenih z jodom, vezanim na beljakovine (PBI - protein-bound iodine), ravnjo
English: Very rare: may affect up to 1 in 10,000 people
Slovenian: Zelo redki: pojavijo se lahko pri največ 1 od 10.000 bolnic
English: Rare: may affect up to 1 in 1,000 people
Slovenian: Redki: pojavijo se lahko pri največ 1 od 1.000 bolnic
English: The effect of CE/BZA on the risk of dementia is unknown.
Slovenian: Vpliv CE/BZA na tveganje za demenco ni znan.
English: The additive effect of all sources of sorbitol from other concomitantly administered medicinal products and dietary sources should be taken into account.
Slovenian: Upoštevati je treba aditivni učinek sočasnega jemanja zdravil, ki vsebujejo sorbitol, in sorbitola, ki ga vnesemo s hrano.
English: Bazedoxifene undergoes little or no cytochrome P450 (CYP)-mediated metabolism.
Slovenian: K presnovi bazedoksifena le malo ali nič prispeva presnova, ki jo uravnava citokrom P450 (CYP).
English: Glucuronidation is the major metabolic pathway.
Slovenian: Glavna presnovna pot je glukuronidacija.
English: How to take DUAVIVE
Slovenian: Kako jemati zdravilo DUAVIVE
English: In one study, amenorrhea was reported in 97% of the women who received CE 0.45 mg/BZA 20 mg during months 10 to 12.
Slovenian: V eni študiji so o amenoreji poročali pri 97 % žensk, ki so prejemale kombinacijo 0,45 mg CE/20 mg BZA, med 10. in 12. mesecem zdravljenja.
English: Intolerance to contact lenses
Slovenian: Očesne bolezni neprenašanje kontaktnih leč
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS AND STRIPS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU IN DVOJNEM TRAKU
English: In rabbit studies with BZA, abortion and an increased incidence of heart (ventricular septal defect) and skeletal system (ossification delays, misshapen or misaligned bones, primarily of the spine and skull) anomalies in the fetuses were present at maternally toxic dosages of  0.5 mg/kg/day (1.5 times the human exposure).
Slovenian: V študijah BZA na kuncih so se pri odmerkih  0,5 mg/kg/dan (izpostavljenost, 1,5-krat večja od tiste pri človeku), ki so bili toksični za mater, pojavljali splav, pri plodovih pa zvečana incidenca anomalij srca (defekt prekatnega pretina) in skeleta (zapoznelo zakostenevanje skeleta, deformirane ali napačno razvrščene kosti, predvsem hrbtenice in lobanje).
English: Oestrogens may be poorly metabolised in women with impaired liver function.
Slovenian: Pri ženskah z okvarjenim delovanjem jeter se estrogeni lahko slabo presnavljajo.
English: - Known, past or suspected oestrogen-dependent malignant tumours (e.g., endometrial cancer).
Slovenian: - Znani, od estrogenov odvisni maligni tumorji (npr. rak endometrija), sum nanje ali od estrogenov odvisni maligni tumorji v anamnezi.
English: In another study, amenorrhea was reported in 96% of the women who received CE 0.45 mg/BZA 20 mg during months 10 to 12.
Slovenian: V drugi študiji so o amenoreji poročali pri 96 % žensk, ki so prejemale kombinacijo 0,45 mg CE/20 mg BZA, med 10. in 12. mesecem zdravljenja.
English: Additional cases per 1,000 never-users of HRT over a 5 year period*
Slovenian: Dodatni primeri na 1.000 žensk, ki niso nikoli uporabljale HNZ v obdobju 5 let*
English: If pregnancy occurs during treatment with CE/BZA, it should be withdrawn immediately.
Slovenian: Če ženska med zdravljenjem s CE/BZA zanosi, je treba uporabo zdravila takoj prekiniti.
English: You may experience breast tenderness, dizziness, abdominal pain, drowsiness/fatigue or experience a short period of vaginal bleeding.
Slovenian: Morda boste imeli občutljive dojke, lahko se pojavijo omotica, bolečine v trebuhu, dremavost/utrujenost ali kratkotrajne krvavitve iz nožnice.
English: If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe' (e.g., antithrombin, protein S, or protein C deficiencies or a combination of defects) hormone therapy is contraindicated.
Slovenian: Če se odkrije trombofilično okvaro, ki sovpada s trombozo pri družinskih članih, ali če je okvara »huda« (npr.
English: Modified-release tablet.
Slovenian: tableta s prirejenim sproščanjem
English: In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods.The reported increase in endometrial cancer risk among oestrogen-onlyusers varies from 2-to 12-fold greater compared with non-users, depending on duration of treatment and oestrogendose.After stopping treatment,risk may remain elevated for at least 10 years.
Slovenian: Zvečano tveganje za raka endometrija, o katerem so poročali pri ženskah, ki so uporabljale samo estrogen, je od 2- do 12-krat večje kot pri neuporabnicah, odvisno pa je od trajanja zdravljenja in odmerka estrogena.
English: • Breast pain, breast tenderness, swollen breasts
Slovenian: • bolečine v dojkah, občutljivost dojk, otekle dojke;
English: Hypromellose 2910 (3 mPa•s) (E464) Sucrose monopalmitate Ascorbic acid
Slovenian: Aktivna obloga iz bazedoksifena saharoza hipromeloza 2910 (3 mPa•s) (E464) saharoza monopalmitat askorbinska kislina
English: Do not take DUAVIVE
Slovenian: Ne jemljite zdravila DUAVIVE
English: In studies conducted in rabbits, bazedoxifene alone has shown reproductive toxicity (see section 5.3).
Slovenian: Študije na kuncih so pri samostojni uporabi bazedoksifena pokazale škodljiv vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: • Migraine
Slovenian: • migrena;
English: Randomised controlled data found no increased risk of coronary artery disease in hysterectomised women using oestrogen-only therapy.
Slovenian: Randomizirani nadzorovani podatki niso pokazali zvečanega tveganja bolezni koronarnih arterij pri ženskah z odstranjeno maternico, ki se zdravijo samo z estrogeni.
English: If VTE develops after initiating therapy, or is suspected, CE/BZA should be discontinued immediately.
Slovenian: Če se po uvedbi zdravljenja pojavi VTE ali sum nanjo, je treba zdravljenje s CE/BZA nemudoma prekiniti.
English: Polydextrose (E1200) (contains glycerol and glucose) Maltitol liquid
Slovenian: Prozorna obloga hidroksietilceluloza povidon (E1201) polidekstroza (E1200) (vsebuje glicerol in glukozo) tekoči maltitol poloksamer 188
English: • Thrush (vaginal yeast infection)
Slovenian: • kandidoza (glivična okužba nožnice);
English: There is no evidence from randomised controlled trials of protection against myocardial infarction in women with or without existing CAD who received oestrogen-only therapy.
Slovenian: Iz randomiziranih nadzorovanih kliničnih preskušanj pri ženskah z obstoječo KAB ali brez nje, ki so uporabljale zdravljenje samo z estrogenom, ni dokazov o zaščiti pred miokardnim infarktom.
English: Treatment of rats with BZA at maternally toxic dosages  1 mg/kg/day ( 0.4 times the human dose based on body surface area) resulted in reduced numbers of live foetuses and/or reductions in foetal body weights.
Slovenian: ( 0,4-kratni odmerek kot pri človeku glede na telesno površino), ki so bili toksični za mater, je povzročilo zmanjšanje števila živih plodov in/ali zmanjšanje telesne mase plodov.
English: Oestrogen dose proportionality was assessed in two studies of CE. Dose-proportional increases in both AUC and Cmax were observed across the dose range from 0.3 mg to 0.625 mg of CE for total (conjugated plus unconjugated) equilin, total estrone adjusted for baseline, and unconjugated estrone adjusted for baseline.
Slovenian: V razponu odmerkov od 0,3 mg do 0,625 mg CE so opazili od odmerka odvisno zvečanje vrednosti AUC in Cmax pri skupnem (konjugiranem in nekonjugiranem) ekvilinu, skupnem estronu, prilagojenem glede na izhodiščno vrednost, in nekonjugiranem estronu, prilagojenem glede na izhodiščno vrednost.
English: Reproductive toxicity and impairment of fertility studies with CE/BZA have not been conducted.
Slovenian: Študije vpliva na razmnoževanje in okvare plodnosti s kombinacijo CE/BZA niso bile izvedene.
English: • Signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain or difficulty in breathing.
Slovenian: • znaki krvnega strdka, kot so boleče otekanje ali rdečica nog, nenadna bolečina v prsnem košu ali težko dihanje;
English: • a high level of fat in your blood (triglycerides)
Slovenian: • zvišane ravni maščob (trigliceridov) v krvi;
English: • changes in the nipple
Slovenian: • spremembe na bradavicah;
English: However, it returns to normal within a few years (at most 5) after stopping treatment.
Slovenian: Dodatno tveganje postane očitno po nekaj letih uporabe, vendar se vrne na izhodiščno vrednost v nekaj (največ petih) letih po prekinitvi zdravljenja.
English: Adverse reactions that have been observed with CE monotherapy
Slovenian: Neželeni učinki, ki so jih opazili pri monoterapiji s CE
English: (see sections 4.6 and 5.3).
Slovenian: in 5.3).
English: A single 20 mg dose of BZA was administered to these subjects.
Slovenian: Tem preiskovankam so dali enkratni 20 mg odmerek BZA.
English: Randomised controlled data found no increased risk of CAD in hysterectomised women using oestrogen-only therapy.
Slovenian: V podatkih iz randomiziranih nadzorovanih študij niso ugotovili zvečanega tveganja za KAB pri ženskah s histerektomijo, ki so uporabljale zdravljenje samo z estrogenom.
English: Following multiple doses of CE 0.45 mg/BZA 20 mg, the mean steady state pharmacokinetic parameters for CE and bazedoxifene (baseline adjusted for total estrone) are summarised below.
Slovenian: Povprečni farmakokinetični parametri CE in bazedoksifena v stanju dinamičnega ravnovesja po večkratnih odmerkih 0,45 mg CE/20 mg BZA (izhodiščne vrednosti so bile prilagojene glede na skupni estron) so povzeti v preglednici spodaj.
English: Dry mouth
Slovenian: Bolezni prebavil suha usta
English: Should a VTE event occur or be suspected, CE/BZA should be discontinued immediately.
Slovenian: Če se pojavi VTE ali sum na njo, je treba zdravljenje s CE/BZA nemudoma prekiniti.
English: The effect of CE/BZA on the risk of breast cancer is unknown.
Slovenian: Vpliv CE/BZA na tveganje za raka dojke ni znan.
English: Common: may affect 1 in 10 people
Slovenian: Pogosti: pojavijo se lahko pri 1 od 10 bolnic
English: The metabolic disposition of CE and BZA, after administration of CE/BZA, has not been studied.
Slovenian: Presnove CE in BZA po uporabi kombinacije CE/BZA niso raziskovali.
English: Each tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene.
Slovenian: Ena tableta vsebuje 0,45 mg konjugiranih estrogenov in bazedoksifenacetat v količini, ki ustreza 20 mg bazedoksifena.
English: Use in this population is not recommended (see sections 4.2 and 5.2).
Slovenian: Uporaba pri tej skupini bolnic ni priporočljiva (glejte poglavji 4.2 in 5.2).
English: • Muscle spasms (including leg cramps)
Slovenian: • mišični krči (vključno s krči v nogah);
English: Each modified-release tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene.
Slovenian: Ena tableta s prirejenim sproščanjem vsebuje 0,45 mg konjugiranih estrogenov in bazedoksifenacetat v količini, ki ustreza 20 mg bazedoksifena.
English: Oral oestrogen-only*
Slovenian: Samo peroralni estrogen*
English: The pharmacokinetics of CE/BZA have not been evaluated in patients with renal impairment.
Slovenian: Farmakokinetike CE/BZA pri bolnicah z okvaro ledvic niso raziskovali.
English: • Hot flushes
Slovenian: • vročinski oblivi;
English: Colour coating
Slovenian: Okvara jeter
English: • getting older
Slovenian: • staranje;
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora poslabšanje astme
English: The effect of DUAVIVE on the risk of ovarian cancer is unknown.
Slovenian: Učinek zdravila DUAVIVE na tveganje za raka jajčnikov ni znan.
English: • seizures (epilepsy)
Slovenian: • epileptični napadi;
English: - Active or past history of venous thromboembolism (e.g., deep venous thrombosis,
Slovenian: - Aktivna venska trombembolija ali venska trombembolija v anamnezi (npr. globoka venska tromboza, pljučna embolija in tromboza mrežnične vene).
English: This may be accompanied by bone pain and abdominal pain.
Slovenian: Pomanjkanje kalcija lahko spremljajo bolečine v trebuhu in kosteh.
English: Hepatic impairment The pharmacokinetics of CE/BZA have not been evaluated in women with hepatic impairment.
Slovenian: Okvara jeter Farmakokinetike kombinacije CE/BZA pri bolnicah z okvaro jeter niso raziskovali.
English: Bazedoxifene elicited male rat-specific nephropathies (corticomedullar nephrocalcinosis and enhanced spontaneous chronic progressive nephropathy) and associated adenomas and carcinomas at exposure ratios of 0.05 to 4 times, and dose ratios, based on surface area (mg/m2), of approximately
Slovenian: Bazedoksifen je pri 0,05- do 4-kratnemu razmerju izpostavljenosti in približno 0,6- do 22-kratnemu razmerju odmerkov glede na površino (mg/m2) v primerjavi s kliničnim odmerkom 20 mg pri samcih podgan izzval za podgane značilne nefropatije (kortikomedularno nefrokalcinozo in okrepljeno spontano kronično progresivno nefropatijo) ter s tem povezane adenome in karcinome.
English: • Drowsiness
Slovenian: • dremavost;
English: The effect of DUAVIVE on the risk of breast cancer is unknown.
Slovenian: Učinek zdravila DUAVIVE na tveganje za raka dojke ni znan.
English: • Increase in hair growth
Slovenian: • intenzivnejša rast las oz. dlak;
English: • A heart attack - symptoms will usually include pain, including chest pain spreading to the jaw, neck and upper arm. You may feel sweaty, breathless, fatigued, nauseous and faint in addition to the pain
Slovenian: • srčna kap - simptomi navadno vključujejo bolečino, kot je bolečina v prsnem košu, ki se širi proti čeljusti in nadlahti.
English: Uncommon: may affect up to 1 in 100 people
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnic
English: - Patients with terminal renal insufficiency should be closely monitored, since it is expected that the level of circulating oestrogens components of CE/BZA will be increased.
Slovenian: - Pričakovati je, da bo raven estrogenskih komponent CE/BZA v obtoku zvišana, zato je treba bolnice s končnim stadijem ledvične insuficience pozorno spremljati.
English: stroke).
Slovenian: • srbenje.
English: • Vomiting
Slovenian: • bruhanje;
English: The effect of CE/BZA on the risk of ovarian cancer is unknown.
Slovenian: Učinek CE/BZA na tveganje za raka jajčnikov ni znan.
English: Abdominal pain Constipation; diarrhoea; nausea
Slovenian: Bolezni prebavil navzea pankreatitis, ishemični kolitis, bruhanje
English: The effect of DUAVIVE on the risk of stroke is unknown.
Slovenian: Učinek zdravila DUAVIVE na tveganje za možgansko kap ni znan.
English: Oestrous cycles and fertility were adversely affected in all bazedoxifene-treated female groups.
Slovenian: V vseh skupinah samic, ki so prejemale bazedoksifen, so opazili neželene učinke na estrusne cikle in plodnost.
English: A.
Slovenian: Po
English: How to store DUAVIVE
Slovenian: Shranjevanje zdravila DUAVIVE
English: - kidney problems - pre-existing high level of fat in your blood (triglycerides) - liver problems - asthma - seizures (epilepsy) - migraine - systemic lupus erythematosus (SLE - a rare disease of the immune system that affects many organs of the body) - fluid retention
Slovenian: - leiomiomi (maternični miomi) ali endometrioza; - dejavniki tveganja za trombembolične motnje (glejte spodaj); - dejavniki tveganja za nastanek od estrogenov odvisnih tumorjev, npr. dedno nagnjenje za raka dojke v 1. kolenu; - hipertenzija; - bolezni jeter (npr. adenom jeter); - sladkorna bolezen s prizadetostjo žilja ali brez nje; - holelitiaza; - migrena ali (hud) glavobol; - sistemski eritematozni lupus; - hiperplazija endometrija v anamnezi (glejte spodaj); - epilepsija; - astma; - otoskleroza.
English: The effect of CE/BZA on the risk of stroke is unknown.
Slovenian: Vpliv CE/BZA na tveganje za možgansko kap ni znan.
English: Hepatic impairment
Slovenian: Ishemična možganska kap
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije periferni edem
English: • diabetes
Slovenian: • sladkorna bolezen;
English: • Hives (urticaria)
Slovenian: • koprivnica (urtikarija);
English: Migraine; headache; dizziness; nervousness
Slovenian: Bolezni živčevja migrena, glavobol, omotica, nervoznost poslabšanje epilepsije poslabšanje horeje
English: Reproductive system and breast disorders
Slovenian: Infekcijske in parazitske bolezni vulvovaginalna kandidoza
English: Talk to your doctor if you have any concerns.
Slovenian: Če imate kakršnekoli skrbi, se posvetujte z zdravnikom.
English: Hypromellose 2208 (100,000 mPa•s) (E464) Magnesium stearate
Slovenian: Jedro tablete s konjugiranimi estrogeni laktoza monohidrat mikrokristalna celuloza celuloza v prahu hipromeloza 2208 (100.000 mPa•s) (E464) magnezijev stearat kalcijev fosfat
English: Glucose intolerance;
Slovenian: • žolčni kamni;
English: Metabolism and nutrition disorders
Slovenian: Infekcijske in parazitske bolezni vaginitis
English: Speak to your doctor if you think this dose is too strong or not strong enough.
Slovenian: Če menite, da je odmerek premočan ali prešibek, se posvetujte z zdravnikom.
English: DUAVIVE (CE/BZA) has not been studied in the treatment of premature menopause.
Slovenian: Zdravljenja prezgodnje menopavze z zdravilom DUAVIVE (CE/BZA) niso raziskovali.
English: • Diarrhoea
Slovenian: • driska;
English: Bazedoxifene-5-glucuronide is the major circulating metabolite.
Slovenian: Znakov presnove prek sistema citokroma P450 je malo ali pa jih ni. Glavni presnovek v obtoku je bazedoksifen-5-glukuronid.
English: • Dizziness
Slovenian: • omotica;
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Vsebnost pomožnih snovi
English: Calcium phosphate
Slovenian: Bolezni živčevja somnolenca
English: Risk ratio & 95%CI Additional cases per 1,000 HRT users over 5 years
Slovenian: Dodatni primeri na 1.000 uporabnic HNZ v obdobju 5 let
English: - CE/BZA must not be taken by women of childbearing potential, or breast-feeding women
Slovenian: - CE/BZA ne smejo jemati ženske v rodni dobi ali doječe matere (glejte poglavji 4.6
English: • Nausea (feeling sick)
Slovenian: • občutek siljenja na bruhanje (slabost);
English: Not known disorders
Slovenian: Preglednica neželenih učinkov
English: CE 0.45 mg/BZA 20 mg demonstrated similar changes in mammographic breast density compared to placebo over 1 year of treatment.
Slovenian: 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.
English: Clear coating
Slovenian: PRETISNI OMOT
English: Breast density
Slovenian: Gostota dojk
English: The mechanism of this interaction is unknown.
Slovenian: Mehanizem tega medsebojnega delovanja ni znan.
English: The doctor will prescribe a suitable dose for you.
Slovenian: Zdravnik vam bo predpisal primeren odmerek.
English: Body Surface Area (m
Slovenian: Površina telesa (m
English: 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.
Slovenian: 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.
English: Manufacturer Eisai Manufacturing Limited Mosquito Way Hatfield
Slovenian: Eisai Manufacturing Limited Mosquito Way Hatfield
English: They may notice these changes and help you identify any problems that you need to talk to your doctor about.
Slovenian: Oni lahko te spremembe opazijo in vam pomagajo odkriti morebitne težave, o katerih bi se morali pogovoriti z zdravnikom.
English: Carcinogenicity studies have not been conducted.
Slovenian: Študije kancerogenosti niso bile izvedene.
English: Hypothyroidism generally occurs 4-8 weeks after commencement of therapy.
Slovenian: Hipotiroidizem se običajno pojavi 4-8 tednov po začetku terapije.
English: Contains sorbitol.
Slovenian: Vsebuje sorbitol.
English: This is important as using more than one medicine at the same time can strengthen or weaken the effect of the medicines.
Slovenian: To je zelo pomembno, saj lahko sočasno jemanje različnih zdravil učinek zdravil poveča ali oslabi.
English: 60528 Frankfurt am Main Germany
Slovenian: 60528 Frankfurt am Main Nemčija
English: Ongoing systemic infection.
Slovenian: Stalna sistemska infekcija.
English: The standard dose should be used in the elderly.
Slovenian: Pri starejših ljudeh je treba uporabiti običajni odmerek.
English: Bexarotene is not genotoxic.
Slovenian: Beksaroten ni genotoksičen.
English: Patients should be monitored for signs of depression and referred for appropriate treatment if necessary.
Slovenian: Bolnike je treba spremljati glede znakov depresije in jih po potrebi napotiti na ustrezno zdravljenje.
English: Do not take more than 15,000 International Units of vitamin A supplements per day during treatment.
Slovenian: Ne vzemite več kot 15.000 mednarodnih enot (i.e.) dodatka vitamina A dnevno v času zdravljenja.
English: Hypervitaminosis A.
Slovenian: Hipervitaminoza A.
English: The recommended dose is generally 4 to 10 capsules to be taken once daily.
Slovenian: Priporočeni odmerek je na splošno med 4 in 10 kapsulami enkrat dnevno.
English: 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.
Slovenian: 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.
English: Treatment should be continued as long as the patient is deriving benefit.
Slovenian: Zdravljenje se mora nadaljevati, dokler je koristno za bolnika.
English: 60528 Frankfurt am Main Germany e-mail: medinfo_de@eisai.net
Slovenian: 60528 Frankfurt am Main Nemčija e-mail: medinfo_de@eisai.net
English: - if you have ever had any mental health problems including depression, aggressive tendencies or mood changes.
Slovenian: - če ste kadar koli imeli težave z duševnim zdravjem, vključno z depresijo, težnjami k agresivnemu vedenju ali spremembami v razpoloženju.
English: Sometimes it is necessary to adjust the dose or interrupt treatment.
Slovenian: Včasih je potrebno odmerek prilagoditi ali zdravljenje prekiniti.
English: Children and adolescents Targretin capsules should not be used in children or adolescents.
Slovenian: Otroci in mladostniki Targretin kapsule se ne smejo uporabljati za otroke ali mladostnike.