FrancophonIA/ELRC3.0 huggingface dataset:
English: What Dacogen looks like and contents of the pack Dacogen is a white to almost white powder for concentrate for solution for infusion.
Croatian: Dacogen je bijeli do gotovo bijeli prašak za koncentrat za otopinu za infuziju.
English: White to almost white lyophilized powder.
Croatian: Liofilizirani prašak bijele do gotovo bijele boje.
English: Cases of cardiomyopathy with cardiac decompensation, in some cases reversible after treatment discontinuation, dose reduction or corrective treatment, have been reported in the postmarketing setting.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi kardiomiopatije sa srčanom dekompenzacijom, koja je u nekim slučajevima bila reverzibilna nakon prekida liječenja, smanjenja doze ili korektivnog liječenja.
English: This prepared diluted solution can be stored refrigerated at 2°C - 8°C for up to a maximum of 3 hours, followed by up to 1 hour at room temperature (20°C - 25°C) before administration.
Croatian: Tako pripremljenu razrijeđenu otopinu može se čuvati u hladnjaku na temperaturi 2°C - 8°C maksimalno 3 sata, a nakon toga do 1 sat na sobnoj temperaturi (20°C - 25°C) prije primjene.
English: How to store Dacogen
Croatian: Kako primjenjivati Dacogen
English: Powder for concentrate for solution for infusion (powder for infusion).
Croatian: Prašak za koncentrat za otopinu za infuziju (prašak za infuziju).
English: The population PK analysis on the limited decitabine data indicated no significant PK parameter dependencies on normalized creatinine clearance, an indicator of renal function.
Croatian: Analiza populacijske farmakokinetike na ograničenim podacima za decitabin nije pokazala značajne ovisnosti farmakokinetičkih parametara o normaliziranom klirensu kreatinina, pokazatelju bubrežne funkcije.
English: • bleeding or bruising more easily - these may be signs of a drop in the number of blood platelets
Croatian: • krvarenje ili lako nastajanje modrica - to mogu biti znakovi pada broja krvnih pločica
English: Caution should be exercised in the administration of Dacogen to patients with severe renal impairment (Creatinine Clearance [CrCl] < 30 ml/min).
Croatian: Kad se Dacogen primjenjuje u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina [CrCl] < 30 ml/min) potrebno je postupati s oprezom.
English: The most commonly reported haematologic adverse drug reactions associated with Dacogen treatment included febrile neutropaenia, thrombocytopaenia, neutropaenia, anaemia and leukopaenia.
Croatian: Najčešće opisane hematološke nuspojave vezane uz liječenje Dacogenom uključuju febrilnu neutropeniju, trombocitopeniju, neutropeniju, anemiju i leukopeniju.
English: Very common febrile neutropaenia* neutropaenia* thrombocytopaenia*
Croatian: Vrlo često febrilna neutropenija neutropenija trombocitopenija
English: Based on the initial analysis in the ITT population, a statistically significant difference in complete remission rate (CR + CRp) was achieved in favour of subjects in the Dacogen arm, 17.8% (43/242) compared to the TC arm, 7.8% (19/243); treatment difference 9.9% (95% CI: 4.07; 15.83), p = 0.0011.
Croatian: Na temelju početne analize u ITT populaciji, statistički značajna razlika u stopi potpune remisije (CR + CRp) postignuta je u prilog ispitanika iz skupine koja je primala Dacogen, 17,8% (43/242) u usporedbi s TC skupinom, 7,8% (19/243); razlika liječenja 9,9% (95% CI: 4,07; 15,83), p = 0,0011.
English: This prepared diluted solution for intravenous infusion can be stored at 2°C - 8°C for up to a maximum of 3 hours, followed by up to 1 hour at room temperature (20°C - 25°C) before administration.
Croatian: Tako pripremljenu razrijeđenu otopinu za intravensku infuziju mora se čuvati na temperaturi 2°C - 8°C do najviše 3 sata, a nakon toga do 1 sat na sobnoj temperaturi (20°C - 25°C) prije primjene.
English: What Dacogen is used for
Croatian: Za što se Dacogen koristi
English: This is because it is not known if the medicine passes into the mother's milk.
Croatian: • Nemojte dojiti ako primate Dacogen, zato što nije poznato prelazi li ovaj lijek u majčino mlijeko.
English: Description of selected adverse drug reactions
Croatian: Opis izabranih nuspojava
English: • abnormal liver function
Croatian: • poremećaj funkcije jetre
English: • The active substance is decitabine.
Croatian: • Djelatna tvar je decitabin.
English: In an analysis with an additional 1 year of mature survival data, the effect of Dacogen on overall survival demonstrated a clinical improvement compared to the TC arm (7.7 months vs. 5.0 months, respectively, hazard ratio = 0.82, 95% CI: 0.68, 0.99, nominal p-value = 0.0373, Figure 2).
Croatian: U analizi razrađenih podataka preživljenja s dodanom 1 godinom, učinak Dacogena na sveukupno preživljenje pokazao je kliničko poboljšanje u usporedbi sa skupinom s izborom liječenja (TC) (7,7 mjeseci u usporedbi s 5,0 mjeseci, omjer hazarda (HR) = 0,82, 95% CI: 0,68; 0,99, nominalna p-vrijednost = 0,0373, slika 2).
English: • sore or runny nose, sore sinuses
Croatian: • bol u nosu ili curenje nosa, bolni sinusi
English: Within 15 minutes of reconstitution, the solution must be further diluted with cold infusion fluids (sodium chloride 9 mg/ml [0.9%] solution for injection or 5% glucose solution for injection) to a final concentration of 0.15 to 1.0 mg/ml.
Croatian: Unutar 15 minuta od rekonstitucije, otopinu se mora dalje razrijediti s hladnom infuzijskom otopinom, (9 mg/ml [ 0,9%-tnom] otopinom natrijevog klorida za injekcije ili s 5%-tnom otopinom glukoze za injekcije), do konačne koncentracije od 0,15 do 1,0 mg/ml.
English: Management of myelosuppression and associated complications Myelosuppression and adverse events related to myelosuppression (thrombocytopaenia, anaemia, neutropaenia, and febrile neutropaenia) are common in both treated and untreated patients with AML.
Croatian: Mijelosupresija i štetni događaji povezani s mijelosupresijom (trombocitopenija, anemija, neutropenija i febrilna neutropenija), česti su i kod liječenih i kod neliječenih bolesnika s AML.
English: After reconstitution with 10 ml of water for injections, each ml of concentrate contains 5 mg of decitabine.
Croatian: Nakon rekonstitucije s 10 ml vode za injekcije, jedan ml koncentrata sadrži 5 mg decitabina.
English: Within 15 minutes of reconstitution, the solution must be further diluted with cold (2C - 8C) infusion fluids (sodium chloride 9 mg/ml [0.9%] solution for injection or 5% glucose solution for injection) to a final concentration of 0.15 to 1.0 mg/ml.
Croatian: Unutar 15 minuta od rekonstitucije, otopinu se mora dalje razrijediti s hladnom(2°C - 8°C) infuzijskom otopinom (9 mg/ml [0,9%-tnom] otopinom natrijevog klorida za injekcije ili 5%-tnom otopinom glukoze za injekcije), do konačne koncentracije od 0,15 do 1,0 mg/ml.
English: Dacogen should not be used in children with AML aged < 18 years, because efficacy was not established.
Croatian: < 18 godina, jer djelotvornost nije ustanovljena.
English: Dacogen 50 mg powder for concentrate for solution for infusion.
Croatian: Dacogen 50 mg prašak za koncentrat za otopinu za infuziju.
English: Liver function tests should be performed prior to initiation of therapy and prior to each treatment cycle, and as clinically indicated (see sections 4.2 and 5.2).
Croatian: Prije započinjanja liječenja i prije svakog ciklusa liječenja, te ako je klinički indicirano, potrebno je napraviti pretrage funkcije jetre (vidjeti dijelove 4.2 i 5.2).
English: The most common adverse drug reactions (≥ 35%) reported are pyrexia, anaemia and thrombocytopaenia.
Croatian: Sažetak profila sigurnosti primjene Najčešće prijavljene nuspojave (≥ 35%) bile su pireksija, anemija i trombocitopenija.
English: Including preferred terms hypersensitivity, drug hypersensitivity, anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock.
Croatian: Uključuje standardne izraze: preosjetljivost, preosjetljivost na lijek, anafilaktička reakcija, anafilaktički šok, anafilaktoidna reakcija, anafilaktoidni šok.
English: • This medicine contains 0.5 mmol potassium in each vial.
Croatian: • Ovaj lijek sadrži 0,5 mmola kalija u jednoj bočici.
English: Very common epistaxis Not known interstitial lung disease
Croatian: Nepoznato intersticijska bolest pluća Nepoznato Nepoznato
English: For the shelf-life and the precautions for storage after reconstitution, see section 5 of the leaflet.
Croatian: Za rok valjanosti i mjere opreza pri čuvanju nakon rekonstitucije, vidjeti dio 5 u uputi o lijeku.
English: Progression-free survival was significantly longer for subjects in the Dacogen arm, 3.7 months (95% CI: 2.7, 4.6) compared with subjects in the TC arm, 2.1 months (95% CI: 1.9, 3.1); hazard ratio 0.75 (95% CI: 0.62, 0.91), p = 0.0031.
Croatian: Preživljenje bez progresije bolesti bilo je značajno dulje u ispitanika iz skupine koja je primala Dacogen, 3,7 mjeseci (95% CI: 2,7; 4,6) u usporedbi s ispitanicima u TC skupini, 2,1 mjesec (95% CI: 1,9; 3,1); omjer hazarda 0,75 (95% CI: 0,62; 0,91), p = 0,0031.
English: The adverse drug reactions are listed by frequency category.
Croatian: Nuspojave su navedene prema kategorijama učestalosti.
English: The median overall survival in the --ITT population was 7.7 months in subjects treated with Dacogen compared to 5.0 months for subjects in the TC arm (hazard ratio 0.85; 95% CI: 0.69, 1.04, p = 0.1079).
Croatian: Medijan ukupnog preživljenja u ITT populaciji bio je 7,7 mjeseci u ispitanika liječenih Dacogenom u usporedbi s 5,0 mjeseci kod ispitanika u skupini s izborom liječenja (TC) (omjer hazarda 0,85; 95% CI: 0,69; 1,04, p = 0,1079).
English: Very common pneumonia* urinary tract infection* All other infections (viral, bacterial, fungal)*
Croatian: Sve druge infekcije (virusne, bakterijske, gljivične)
English: • inflamed gut (enterocolitis, colitis and caecitis), with symptoms of abdominal pain, bloating, or diarrhoea.
Croatian: • upala crijeva (enterokolitis, kolitis i upala slijepog crijeva), sa simptomima boli u trbuhu, nadutosti ili proljeva.
English: Potassium dihydrogen phosphate (E340) Sodium hydroxide (E524) Hydrochloric acid (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari kalijev dihidrogenfosfat (E340) natrijev hidroksid (E524) kloridna kiselina (za podešavanje pH)
English: Excipients: potassium dihydrogen phosphate (E340), sodium hydroxide (E524), and hydrochloric acid.
Croatian: Pomoćne tvari: kalijev dihidrogenfosfat (E340), natrijev hidroksid (E524) i kloridna kiselina.
English: Dacogen 50 mg powder for infusion decitabine
Croatian: Dacogen 50 mg prašak za infuziju decitabin i.v.
English: For the shelf-life and the precaution for storage after reconstitution, see section 6.3.
Croatian: Za rok valjanosti i mjere opreza pri čuvanju nakon rekonstitucije vidjeti dio 6.3.
English: • urine infection
Croatian: • infekcija mokraćnog sustava
English: Recommendations for safe handling
Croatian: Preporuke za sigurno rukovanje lijekom
English: Dacogen 50 mg powder for concentrate for solution for infusion decitabine
Croatian: Dacogen 50 mg prašak za koncentrat za otopinu za infuziju decitabin
English: The PK of decitabine have not been formally studied in patients with hepatic impairment.
Croatian: Farmakokinetika decitabina nije službeno ispitivana u bolesnika s bubrežnom insuficijencijom.
English: You may feel tired or weak after using Dacogen.
Croatian: Nakon primjene Dacogena, možete osjećati umor ili slabost.
English: • Your doctor, nurse or pharmacist is responsible for storing Dacogen.
Croatian: • Za čuvanje Dacogena odgovoran je Vaš liječnik, medicinska sestra ili ljekarnik.
English: Based on these negative results, Dacogen should not be used in children with AML aged < 18 years, because efficacy was not established (see section 4.2).
Croatian: < 18 godina, jer nije ustanovljena djelotvornost (vidjeti dio 4.2).
English: Renal function tests should be performed prior to initiation of therapy and prior to each treatment cycle, and as clinically indicated (see section 4.2).
Croatian: Prije započinjanja liječenja i prije svakog ciklusa liječenja, te ako je klinički indicirano, potrebno je napraviti pretrage funkcije bubrega (vidjeti dio 4.2).
English: 9 subjects received cytarabine 1 g/m 2 and 8 subjects received cytarabine administered at the maximum tolerable dose of 2 g/m2.
Croatian: Bilo je uključeno ukupno 17 ispitanika koji su u ovom ispitivanju primili 20 mg/m2 lijeka Dacogen, od kojih je 9 ispitanika primilo 1 g/m2 citarabina, a 8 ispitanika je primilo citarabin primijenjen u maksimalnoj dozi koja se podnosi od 2 g/m2.
English: Caution should be exercised in the administration of Dacogen to patients with hepatic impairment and in patients who develop signs or symptoms of hepatic impairment.
Croatian: Kad se Dacogen primjenjuje u bolesnika s oštećenom funkcijom jetre i u bolesnika kod kojih se razviju znakovi ili simptomi oštećenja funkcije jetre potrebno je postupati s oprezom.
English: Cases of interstitial lung disease (ILD) (including pulmonary infiltrates, organising pneumonia and pulmonary fibrosis) without signs of infectious aetiology have been reported in patients receiving decitabine.
Croatian: U bolesnika koji primaju decitabin bili su prijavljeni slučajevi intersticijske bolesti pluća (IBP) (uključujući plućne infiltrate, organizirajuću pneumoniju i plućnu fibrozu) bez znakova infektivne etiologije.
English: Progression-free survival and Event-free survival were tertiary endpoints.
Croatian: Mjere tercijarnih ishoda bili su preživljenje bez progresije bolesti i preživljenje bez pojave događaja.
English: • The other ingredients are potassium dihydrogen phosphate (E340), sodium hydroxide(E524), and hydrochloric acid (for pH-adjustment).
Croatian: • Drugi sastojci su kalijev dihidrogenfosfat (E 340), natrijev hidroksid (E524) i kloridna kiselina
English: Each vial contains 50 mg decitabine.
Croatian: Jedna bočica sadrži 50 mg decitabina.
English: RECONSTITUTION
Croatian: REKONSTITUCIJA
English: This includes medicines obtained without a prescription and herbal medicines.
Croatian: To uključuje lijekove koji se kupuju bez recepta i biljne lijekove, zbog toga što Dacogen može utjecati na djelovanje drugih lijekova.
English: Each vial of powder for concentrate for solution for infusion contains 50 mg decitabine.
Croatian: Jedna bočica praška za koncentrat za otopinu za infuziju sadrži 50 mg decitabina.
English: Neurobehavioural development and reproductive capacity were unaffected when neonatal/juvenile rats were treated at dose levels inducing myelosuppression.
Croatian: Prilikom liječenja novorođenih/mladih štakora dozama koje izazivaju mijelosupresiju, nije bilo utjecaja na neurobihevioralni razvoj i reproduktivni kapacitet.
English: • feeling tired or looking pale - these may be signs of a drop in the number of red blood cells
Croatian: • osjećaj umora ili bljedilo - to mogu biti znakovi pada broja crvenih krvnih stanica (anemija)
English: Thus, decitabine exposure is not likely to be affected in patients with impaired hepatic function.
Croatian: Stoga nije vjerojatno da u bolesnika s oštećenom funkcijom jetre postoji utjecaj na izloženost decitabinu.
English: 95% confidence intervals
Croatian: - = ne može se procijeniti navedeno kao medijan mjeseci 95% intervali pouzdanosti
English: Very common hepatic function abnormal Common hyperbilirubinaemia
Croatian: Često hiperbilirubinemija
English: Each vial of powder contains 50 mg decitabine.
Croatian: Jedna bočica praška sadrži 50 mg decitabina.
English: Occurrences of enterocolitis, including neutropaenic colitis, caecitis have been reported during treatment with decitabine.
Croatian: Tijekom liječenja decitabinom bili su prijavljeni enterokolitis, uključujući neutropenijski kolitis i upala slijepog crijeva.
English: Thus, decitabine exposure is not likely to be affected in patients with impaired renal function.
Croatian: Stoga nije vjerojatno da u bolesnika s oštećenom funkcijom bubrega postoji utjecaj na izloženost decitabinu.
English: This medicine contains 0.5 mmol potassium per vial.
Croatian: Ovaj lijek sadrži 0,5 mmola kalija u jednoj bočici.
English: Use in patients with severe renal impairment has not been studied.
Croatian: Primjena u bolesnika s teškim oštećenjem funkcije bubrega nije ispitana.
English: Infections and infestations adverse drug reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: Studies in patients with hepatic impairment have not been conducted.
Croatian: Nisu provedena ispitivanja u bolesnika s oštećenom funkcijom bubrega.
English: Thirty-six percent of subjects had poor-risk cytogenetics at baseline.
Croatian: Trideset i šest posto ispitanika imalo je citogenetski nalaz nepovoljne prognoze prije početka liječenja.
English: Very common diarrhoea vomiting nausea Common stomatitis Not known enterocolitis, including neutropaenic colitis, caecitis*
Croatian: Nepoznato enterokolitis, uključujući neutropenijski kolitis, upala slijepog crijeva*
English: ADMINISTRATION
Croatian: Učestalost
English: If you get side effects, talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Elderly
Croatian: Ishodi
English: • Your doctor, nurse or pharmacist is responsible for disposing of any unused Dacogen correctly.
Croatian: • Za pravilno zbrinjavanje neupotrijebljenog Dacogena odgovorni su Vaš liječnik, medicinska sestra ili ljekarnik.
English: Parameter
Croatian: Stupnjevi
English: NA
Croatian: Nuspojava
English: 8 MARKETING AUTHORISATION NUMBER
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Frequency (all Grades) Adverse Drug Reaction
Croatian: Vrlo često dijareja povraćanje mučnina
English: Reported as median months
Croatian: 4 tjedna Parametar
English: • Difficulty breathing, swelling of the lips, itching or rash: This may be due to an allergic (hypersensitivity) reaction (common).
Croatian: To može biti zbog alergijske reakcije (preosjetljivost) (često).
English: Use in patients with hepatic impairment has not been established.
Croatian: Primjena u bolesnika s oštećenjem funkcije jetre nije ispitana.
English: (body surface area).
Croatian: (za podešavanje pH).
English: The usual dose is 160 mg once a day, at about the same time each day.
Croatian: Preporučena doza iznosi 160 mg jednom dnevno, otprilike u isto vrijeme svakog dana.
English: Xtandi (enzalutamide)
Croatian: Xtandi (enzalutamid)
English: Further information on Xtandi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Xtandi.
Croatian: Više informacija o lijeku Xtandi nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Xtandi.
English: Xtandi is not for use in women and must not be given to women who are or who may be pregnant.
Croatian: Xtandi nije za primjenu u žena i ne smije se davati ženama koje su trudne ili bi mogle biti trudne.
English: What measures are being taken to ensure the safe and effective use of Xtandi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xtandi?
English: Xtandi is available as capsules (40 mg) and tablets (40 and 80 mg) and can only be obtained with a prescription.
Croatian: Lijek Xtandi dostupan je u obliku kapsula (40 mg) i tableta (40 i 80 mg), a izdaje se samo na liječnički recept.
English: Why is Xtandi authorised in the EU?
Croatian: Zašto je Xtandi odobren u EU-u?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xtandi have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Xtandi također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: • hormone therapy has not worked, and the patient has either no symptoms or mild symptoms and does not yet require chemotherapy (another type of cancer treatment).
Croatian: • kad hormonska terapije nije djelovala, a bolesnik nema simptome ili ima blage simptome te mu još nije potrebna kemoterapija (druga vrsta terapije protiv raka).
English: It is used when the cancer is metastatic (has spread to other parts of the body), castration resistant (worsens despite treatment to lower production of testosterone or after surgical removal of the testes) and when either:
Croatian: Primjenjuje se kad je rak metastatski (proširio se u druge dijelove tijela), rezistentan na kastraciju (pogoršava se usprkos terapiji za smanjenu proizvodnju testosterona ili nakon kirurškog uklanjanja testisa) i kad bilo:
English: In addition, seizures (fits) can occur in around 4 patients in 1,000.
Croatian: Nadalje, u oko 4 bolesnika na 1000 mogu se pojaviti napadaji.
English: Because prostate cancer needs testosterone and other male hormones to survive and grow, by blocking the effects of these hormones, enzalutamide slows down the growth of the prostate cancer.
Croatian: Budući da je raku prostate potreban testosteron i drugi muški hormoni za preživljenje i rast, blokiranjem učinaka tih hormona enzalutamid usporava razvoj raka prostate.
English: What is Xtandi and what is it used for?
Croatian: Što je Xtandi i za što se primjenjuje?
English: The active substance in Xtandi, enzalutamide, works by blocking the action of the male hormone testosterone and other male hormones known as androgens.
Croatian: Djelatna tvar u lijeku Xtandi, enzalutamid, djeluje blokiranjem aktivnosti muškog hormona testosterona i drugih muških hormona poznatih kao androgeni.
English: • treatment with docetaxel (a cancer medicine) has not worked or no longer works; or
Croatian: • liječenje docetakselom (lijekom protiv raka) nije djelovalo, odnosno više ne djeluje, ili
English: Other important side effects include falls, cognitive disorder (problems with thinking, learning and memory), and neutropenia (low levels of neutrophils, a type of white blood cells).
Croatian: Druge važne nuspojave uključuju padove, kognitivne poremećaje (teškoće u prosuđivanju, učenju i pamćenju) i neutropeniju (niske razine neutrofila, vrste bijelih krvnih stanica).
English: The European Medicines Agency considered that the anticancer effects of Xtandi had been clearly demonstrated and that its benefit in prolonging life for patients with metastatic disease is important for patients.
Croatian: Europska agencija za lijekove smatrala je da su učinci lijeka Xtandi protiv raka jasno utvrđeni i da su njegove koristi u produljenju života važne za bolesnike s metastatskom bolešću.
English: The most common side effects with Xtandi (which may affect more than 1 in 10 people) are tiredness, fractures (broken bones), hot flushes and hypertension (high blood pressure).
Croatian: Najčešće su nuspojave lijeka Xtandi (mogu se javiti u više od 1 na 10 osoba) umor, frakture (lomovi kostiju), navale vrućine i hipertenzija (visoki krvni tlak).
English: Enzalutamide does this by blocking the receptors to which these hormones attach.
Croatian: Enzalutamid blokira receptore na koje se ti hormoni vežu.
English: Xtandi has also been shown to delay the development of metastatic disease.
Croatian: Xtandi se također pokazao djelotvornim u odgodi metastatske bolesti.
English: Regarding its safety, the side effects with Xtandi were generally mild and could be managed appropriately.
Croatian: U pogledu sigurnosti, nuspojave lijeka Xtandi bile su uglavnom blage i moglo ih se uspješno kontrolirati.
English: An overview of Xtandi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Xtandi i zašto je odobren u EU-u
English: The medicine contains the active substance enzalutamide.
Croatian: Lijek sadrži djelatnu tvar enzalutamid.
English: Side effects reported with Xtandi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Xtandi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Xtandi can also be used for castration-resistant prostate cancer that is not metastatic (has not yet spread) but is at high risk of doing so.
Croatian: Xtandi se također može primjenjivati za rak prostate rezistentan na kastraciju koji nije metastatski (još se nije proširio), međutim postoji visok rizik od njegova širenja.