FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Po rezultatih začetne analize podatkov ITT populacije je prišlo do statistično značilne razlike pri deležu bolnikov, ki so dosegli popolno remisijo (CR + CRp), pri čemer je bil delež teh bolnikov večji v skupini z zdravilom Dacogen (17,8% (43/242)) v primerjavi s tovrstnim deležem v skupini z izbranim zdravilom (7,8% (19/243)); razlika med njima pa je znašala 9,9% (95-odstotni IZ: 4,07; 15,83), vrednost p = 0,0011.
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.
Slovenian: Tako pripravljeno razredčeno raztopino je treba hraniti v hladilniku pri 2 °C - 8 °C, in sicer največ 3 ure, nato pa jo je pred uporabo mogoče največ 1 uro hraniti pri sobni temperaturi (20 °C - 25 °C).
English: After reconstitution, 1 ml concentrate contains 5 mg decitabine.
Slovenian: Po rekonstituciji vsebuje 1 ml koncentrata 5 mg decitabina.
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).
Slovenian: Po dodatnem 1 letu opazovanja (podatkov o preživetju po daljšem času opazovanja) so rezultati analize vpliva zdravila Dacogen na celokupno preživetje pokazali klinično izboljšanje v primerjavi s skupino z izbranim zdravilom (7,7 meseca v primerjavi s 5,0 meseca, razmerje tveganja = 0,82, 95odstotni IZ: 0,68, 0,99, nominalna vrednost p = 0,0373, slika 2).
English: The most commonly reported haematologic adverse drug reactions associated with Dacogen treatment included febrile neutropaenia, thrombocytopaenia, neutropaenia, anaemia and leukopaenia.
Slovenian: Hematološki neželeni učinki, ki so povezani z zdravilom Dacogen in o katerih so najbolj pogosto poročali, vključujejo febrilno nevtropenijo, trombocitopenijo, nevtropenijo, anemijo in levkopenijo.
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.
Slovenian: Raztopino je treba v 15 minutah po rekonstituciji dodatno razredčiti s hladno (2°C - 8°C) infuzijsko tekočino (9 mg/ml [0,9%] raztopino natrijevega klorida za injiciranje ali s 5-odstotno raztopino glukoze za injiciranje) do končne koncentracije od 0,15 do 1,0 mg/ml.
English: No formal clinical drug interaction studies with decitabine have been conducted.
Slovenian: Formalnih kliničnih študij medsebojnega delovanja z decitabinom niso izvedli.
English: Talk to your doctor if you are on a low salt diet.
Slovenian: Če ste na dieti z zmanjšanim vnosom soli, se pogovorite z zdravnikom.
English: It is supplied in a 20 ml glass vial containing 50 mg decitabine.
Slovenian: Na voljo je v 20-mililitrski stekleni viali, ki vsebuje 50 mg decitabina.
English: • Haemorrhage (gastrointestinal, genito-urinary, pulmonary with platelets < 25,000/µL or any central nervous system haemorrhage)
Slovenian: • krvavitev (gastrointestinalna krvavitev, krvavitev v urogenitalnem sistemu ali v pljučih s koncentracijo trombocitov < 25.000/µl ali kakršnakoli krvavitev v centralnem živčevju).
English: • red, raised painful patches on the skin, fever, an increase in white blood cells - these may be signs of ‘Acute Febrile Neutrophilic Dermatosis' or ‘Sweet's Syndrome'
Slovenian: zvečano število belih krvnih celic - so lahko znaki "akutne febrilne nevtrofilne dermatoze" ali
English: The time period following treatment with Dacogen where it is safe to become pregnant is unknown.
Slovenian: Ni znano, kdaj je po zaključku zdravljenja z zdravilom Dacogen varno zanositi.
English: • The other ingredients are potassium dihydrogen phosphate (E340), sodium hydroxide(E524), and hydrochloric acid (for pH-adjustment).
Slovenian: • Druge sestavine zdravila so kalijev dihidrogenfosfat(E340), natrijev hidroksid(E524) in klorovodikova kislina (za uravnavanje pH).
English: Common hypersensitivity including anaphylactic reaction
Slovenian: Bolezni imunskega sistema pogosti preobčutljivost, vključno z anafilaktično reakcijo
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.
Slovenian: Obravnava mielosupresije in z njo povezanih zapletov Do mielosupresije in z njo povezanih neželenih učinkov (trombocitopenije, anemije, nevtropenije in febrilne nevtropenije) pride pogosto tako pri zdravljenih kot pri nezdravljenih bolnikih z AML.
English: • liver disease,
Slovenian: • bolezen jeter,
English: After reconstitution with 10 ml of water for injections, each ml of concentrate contains 5 mg of decitabine.
Slovenian: Po rekonstituciji z 10 ml vode za injekcije en mililiter koncentrata vsebuje 5 mg decitabina.
English: • abnormal liver function
Slovenian: • nenornalne vrednosti preiskav delovanja jeter
English: Each vial contains 50 mg decitabine.
Slovenian: Ena viala vsebuje 50 mg decitabina.
English: After reconstitution and dilution of the solution for intravenous infusion, this medicine contains between 13.8 mg-138 mg (0.6-6 mmol) sodium per dose (depending on the infusion fluid for dilution), equivalent to 0.7-7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: Po rekonstituciji in razredčitvi raztopine za intravensko infundiranje to zdravilo vsebuje 13,8 mg-138 mg (0,6-6 mmol) natrija na odmerek, odvisno od infuzijske tekočine za razredčenje.
English: You may feel tired or weak after using Dacogen.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Po uporabi zdravila Dacogen boste morda utrujeni ali brez moči.
English: What you need to know before you are given Dacogen
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Dacogen
English: Serious bleeding-related adverse drug reactions, some of which lead to a fatal outcome, such as central nervous system (CNS) haemorrhage (2%) and gastrointestinal (GI) haemorrhage (2%), in the context of severe thrombocytopaenia, were reported in patients receiving decitabine.
Slovenian: Pri bolnikih, ki so prejemali decitabin, so poročali o resnih neželenih učinkih v povezavi s krvavitvami, od katerih so bili nekateri smrtni, na primer krvavitev v centralno živčevje (2%) in gastrointestinalna krvavitev (2%).
English: Myelosuppression and complications of myelosuppression, including infections and bleeding that occur in patients with AML may be exacerbated with Dacogen treatment.
Slovenian: Zdravljenje z zdravilom Dacogen lahko poslabša mielosupresijo in z njo povezane zaplete, vključno z okužbami in krvavitvami, ki se pojavljajo pri bolnikih z AML.
English: Eighty-one percent of subjects had significant comorbidities (e.g., infection, cardiac impairment, pulmonary impairment).
Slovenian: Enainosemdeset odstotkov preiskovancev je imelo sočasno še druge pomembne bolezni (na primer okužbo ali katero od bolezni srca ali pljuč).
English: Excipients: potassium dihydrogen phosphate (E340), sodium hydroxide (E524), and hydrochloric acid.
Slovenian: Pomožne snovi: kalijev dihidrogenfosfat (E340), natrijev hidroksid (E524) in klorovodikova kislina.
English: The median time to best response and median duration of best response in patients who achieved a CR or CRp were 4.3 months and 8.3 months, respectively.
Slovenian: Pri bolnikih, ki so dosegli popolno remisijo oziroma popolno remisijo z nepopolno normalizacijo vrednosti trombocitov, je bil mediani čas do največjega odziva 4,3 meseca, mediano trajanje največjega odziva pa je znašalo 8,3 meseca.
English: 9 subjects received cytarabine 1 g/m 2 and 8 subjects received cytarabine administered at the maximum tolerable dose of 2 g/m2.
Slovenian: V to študijo so skupno vključili 17 preiskovancev, ki so prejemali 20 mg/m zdravila Dacogen, med njimi je 9 preiskovancev prejemalo 1 g/m citarabina, 8 preiskovancev pa je prejemalo največji sprejemljivi odmerek citarabina 2 g/m2.
English: This is because it is not known if the medicine passes into the mother's milk.
Slovenian: • Če prejemate zdravilo Dacogen, ne smete dojiti, saj ni znano, ali zdravilo prehaja v materino mleko.
English: RECONSTITUTION
Slovenian: REKONSTITUCIJA
English: What Dacogen contains
Slovenian: Kaj vsebuje zdravilo Dacogen
English: • inflamed gut (enterocolitis, colitis and caecitis), with symptoms of abdominal pain, bloating, or diarrhoea.
Slovenian: • vnetje črevesa (tankega, debelega, slepega črevesa), s simptomi bolečine v trebuhu, napenjanja ali driske.
English: Use in patients with severe renal impairment has not been studied.
Slovenian: Uporabe zdravila pri bolnikih s hudo okvaro ledvic niso proučevali.
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.
Slovenian: Preživetje brez napredovanja bolezni je bilo statistično značilno daljše v skupini bolnikov z zdravilom Dacogen 3,7 meseca, (95-odstotni IZ: 2,7; 4,6) v primerjavi s skupino z izbranim zdravilom, v kateri je znašalo 2,1 meseca (95-odstotni IZ: 1,9; 3,1); razmerje tveganja 0,75 (95-odstotni IZ: 0,62; 0,91), p = 0,0031.
English: After preparing the medicine, it contains between 13.8 mg-138 mg sodium per dose , equivalent to 0.7-7% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: Po pripravi zdravilo vsebuje med 13,8 mg in 138 mg natrija na odmerek.
English: Predicted Value
Slovenian: 4 tedne parameter napovedana vrednost
English: • a heart disorder.
Slovenian: • bolezen srca.
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).
Slovenian: V ITT populaciji je bila pri bolnikih, ki so prejemali zdravilo Dacogen, mediana vrednost celokupnega preživetja 7,7 mesecev v primerjavi s 5,0 mesecev pri bolnikih iz skupine z izbranim zdravilom (razmerje tveganja 0,85; 95-odstotni IZ: 0,69, 1,04, p = 0,1079).
English: Treatment for overdose should be supportive.
Slovenian: Zdravljenje v primeru prevelikega odmerjanja je uvedba podpornih ukrepov.
English: Dacogen 50 mg powder for concentrate for solution for infusion decitabine
Slovenian: Dacogen 50 mg prašek za koncentrat za raztopino za infundiranje
English: Infections and infestations adverse drug reactions
Slovenian: Infekcijski in parazitski neželeni učinki
English: • feeling tired or looking pale - these may be signs of a drop in the number of red blood cells
Slovenian: • utrujenost ali bledica - sta lahko znaka zmanjšanega števila rdečih krvnih celic (anemije)
English: Neurobehavioural development and reproductive capacity were unaffected when neonatal/juvenile rats were treated at dose levels inducing myelosuppression.
Slovenian: Nevrovedenjski razvoj in sposobnost razmnoževanja pri neonatalnih/juvenilnih podganah, zdravljenih z odmerki, ki inducirajo mielosupresijo, nista bila prizadeta (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Potassium dihydrogen phosphate (E340) Sodium hydroxide (E524) Hydrochloric acid (for pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi kalijev dihidrogenfosfat (E340) natrijev hidroksid (E524) klorovodikova kislina (za uravnavanje pH)
English: Each vial of powder for concentrate for solution for infusion contains 50 mg decitabine.
Slovenian: Ena viala s praškom za koncentrat za raztopino za infundiranje vsebuje 50 mg decitabina.
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji in razredčevanju zdravila glejte poglavje 6.3.
English: In the ITT analysis, a CR rate of 23.6% (95% CI: 13.2, 37) was observed in 13/55 subjects treated with Dacogen.
Slovenian: V ITT populaciji je bil pri bolnikih, ki so prejemali Dacogen, delež tistih, ki so dosegli popolno remisijo, 23,6% (95-odstotni IZ: 13,2; 37)(13/55).
English: • Your doctor, nurse or pharmacist is responsible for disposing of any unused Dacogen correctly.
Slovenian: • Za ustrezno odstranjevanje morebitnega neuporabljenega zdravila Dacogen je odgovoren vaš zdravnik, medicinska sestra ali farmacevt.
English: Haematologic adverse drug reactions
Slovenian: Hematološki neželeni učinki
English: Danmark Janssen-Cilag A/S Tlf: +45 4594 8282
Slovenian: Janssen-Cilag A/S Tlf: +45 45 94 82 82
English: However, the population pharmacokinetic analysis of decitabine indicated that race had no apparent effect on the exposure to decitabine.
Slovenian: Bolniki v študijah so bili večinoma belci, vendar rezultati analize populacijske farmakokinetike decitabina kažejo, da rasna pripadnosti nima očitnega vpliva na izpostavljenost decitabinu.
English: Thus; CYP-mediated metabolic drug interactions are not anticipated, and decitabine is unlikely to interact with agents metabolized through these pathways.
Slovenian: Zato ni pričakovati presnovnih interakcij v povezavi z encimskim sistemom CYP oziroma medsebojnega delovanja s snovmi, ki se presnavljajo po tej poti.
English: Uncommon Cardiomyopathy
Slovenian: Srčne bolezni občasni kardiomiopatija
English: Very common hepatic function abnormal Common hyperbilirubinaemia
Slovenian: Bolezni jeter, žolčnika in žolčevodov zelo pogosti nenormalno delovanje jeter pogosti hiperbilirubinemija
English: Dacogen 50 mg powder for infusion decitabine
Slovenian: Dacogen 50 mg prašek za koncentrat za raztopino za infundiranje decitabin
English: Progression-free survival and Event-free survival were tertiary endpoints.
Slovenian: Terciarna cilja opazovanja pa sta bila preživetje brez napredovanja bolezni in preživetje brez dogodkov.
English: • urine infection
Slovenian: • okužba sečil
English: The most common adverse drug reactions (≥ 35%) reported are pyrexia, anaemia and thrombocytopaenia.
Slovenian: Najpogosteje poročani neželeni učinki (≥ 35%), so zvišana telesna temperatura, anemija in trombocitopenija.
English: Each vial of powder contains 50 mg decitabine.
Slovenian: Ena viala s praškom vsebuje 50 mg decitabina.
English: Talk to your doctor, pharmacist or nurse before using Dacogen if you have
Slovenian: Pred začetkom uporabe zdravila Dacogen se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate:
English: Studies in patients with renal impairment have not been conducted.
Slovenian: Študij pri bolnikih z okvaro ledvic niso izvedli.
English: Very common headache
Slovenian: Bolezni živčevja zelo pogosti glavobol
English: For the shelf-life and the precautions for storage after reconstitution, see section 5 of the leaflet.
Slovenian: Za rok uporabnosti in previdnostne ukrepe pri shranjevanju rekonstituiranega zdravila glejte poglavje 5 v navodilu za uporabo zdravila.
English: Talk to your doctor or nurse if you have any questions about how Dacogen works or why this medicine has been prescribed for you.
Slovenian: Če vas zanima, kako zdravilo Dacogen deluje ali zakaj so vam predpisali to zdravilo, se obrnite na svojega zdravnika ali medicinsko sestro.
English: Use in patients with hepatic impairment has not been established.
Slovenian: Uporabe zdravila pri bolnikih z okvaro jeter niso določili.
English: • bleeding or bruising more easily - these may be signs of a drop in the number of blood platelets
Slovenian: • krvavitve ali podplutbe brez posebnega vzroka - so lahko znaki zmanjšanega števila krvnih ploščic (trombocitopenije)
English: Thirty-six percent of subjects had poor-risk cytogenetics at baseline.
Slovenian: Šestintrideset odstotkov preiskovancev je imelo ob izhodišču nizko citogenetsko stopnjo tveganja, preostali preiskovanci pa so imeli srednjo citogenetsko stopnjo tveganja.
English: What Dacogen is used for
Slovenian: Za kaj uporabljamo zdravilo Dacogen
English: How to store Dacogen
Slovenian: Shranjevanje zdravila Dacogen
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.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pri bolnikih, ki so prejemali decitabin so poročali o primerih intersticijske bolezni pljuč (ILDInterstitial Lung Disease) (vključno s pljučnimi infiltrati, organizirano pljučnico in pljučno fibrozo) brez znakov infekcijske etiologije.
English: Cases of interstitial lung disease (including pulmonary infiltrates, organising pneumonia and pulmonary fibrosis) without signs of infectious aetiology have been reported in patients receiving decitabine.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pri bolnikih, ki so prejemali decitabin so poročali o primerih intersticijske bolezni pljuč (vključno s pljučnimi infiltrati, organizirano pljučnico in pljučno fibrozo) brez znakov infekcijske etiologije.
English: Thus, decitabine exposure is not likely to be affected in patients with impaired renal function.
Slovenian: Okvara jeter torej verjetno ne vpliva na izpostavljenost decitabinu.
English: Occurrences of enterocolitis, including neutropaenic colitis, caecitis have been reported during treatment with decitabine.
Slovenian: Med zdravljenjem z decitabinom so poročali o pojavu enterokolitisa, vključno z nevtropeničnim kolitisom in vnetjem slepega črevesa.
English: If you get side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Including preferred terms hypersensitivity, drug hypersensitivity, anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock.
Slovenian: vključuje infekcijski enterokolitis vključuje krvavitve, ki so povezane s trombocitopenijo, vključno s smrtnimi primeri vključuje prednostne izraze: preobčutljivost, preobčutljivost na zdravilo, anafilaktična reakcija, anafilaktični šok, anafilaktoidna reakcija in anafilaktoidni šok
English: The PK of decitabine have not been formally studied in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro ledvic niso formalno proučevali farmakokinetike decitabina.
English: This may be a sign of bleeding in the stomach or gut (common).
Slovenian: • Krvavitev: mednje sodi tudi prisotnost krvi v blatu, ki je lahko znak krvavitve v želodcu ali črevesju (pogosto).
English: Tell your doctor immediately if you become pregnant during treatment with Dacogen.
Slovenian: Če med zdravljenjem z zdravilom Dacogen zanosite, takoj obvestite zdravnika.
English: This is because for this medicine to be as effective as possible, it is important to follow the dosing schedule.
Slovenian: Za uspešno zdravljenje je zelo pomembno, da pridete na vsak dogovorjeni obisk.
English: Studies in patients with hepatic impairment have not been conducted.
Slovenian: Študij pri bolnikih z okvaro jeter niso izvedli.
English: Very common diarrhoea vomiting nausea Common stomatitis Not known enterocolitis, including neutropaenic colitis, caecitis*
Slovenian: Bolezni prebavil zelo pogosti driska bruhanje navzea pogosti stomatitis neznana pogostnost enterokolitis, vključno z nevtropeničnim kolitisom, vnetjem slepega črevesa neznana neznana
English: Very common febrile neutropaenia* neutropaenia* thrombocytopaenia*
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti febrilna nevtropenija nevtropenija trombocitopenija
English: Very common hyperglycaemia
Slovenian: Presnovne in prehranske motnje zelo pogosti hiperglikemija
English: , e anaemia leukopaenia
Slovenian: *, e anemija levkopenija občasni pancitopenija
English: Excipients
Slovenian: citotoksično
English: • Your doctor will work out your dose of Dacogen.
Slovenian: • Zdravnik bo izračunal, kolikšen odmerek zdravila Dacogen potrebujete, kar je odvisno od vaše telesne višine in mase (oziroma od telesne površine).
English: • nose bleeds
Slovenian: • krvavitve iz nosu
English: Tell your doctor or nurse immediately if you notice any of the following serious side effects
Slovenian: Če opazite katerega od naslednjih resnih neželenih učinkov, takoj obvestite zdravnika ali medicinsko sestro
English: No. of Subjects at Risk DACOGEN Total TC
Slovenian: Št. ogroženih preiskovancev DACOGEN izbr.
English: The usual dose is 160 mg once a day, at about the same time each day.
Slovenian: Običajni odmerek je 160 mg enkrat na dan vedno ob istem času.
English: Xtandi (enzalutamide)
Slovenian: Xtandi (enzalutamid)
English: Further information on Xtandi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Xtandi.
Slovenian: Nadaljnje informacije o zdravilu Xtandi so na voljo na spletni strani 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.
Slovenian: Zdravilo Xtandi ni namenjeno uporabi pri ženskah in se ne sme dajati ženskam, ki so ali bi lahko bile noseče.
English: What measures are being taken to ensure the safe and effective use of Xtandi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xtandi?
English: Xtandi received a marketing authorisation valid throughout the EU on 21 June 2013.
Slovenian: Za zdravilo Xtandi je bilo 21. junija 2013 izdano dovoljenje za promet, veljavno po vsej EU.
English: The Agency therefore concluded that Xtandi's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Agencija je zato zaključila, da so koristi zdravila Xtandi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Xtandi is available as capsules (40 mg) and tablets (40 and 80 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Xtandi je na voljo v obliki kapsul (40 mg) in tablet (40 mg in 80 mg), njegovo predpisovanje in izdaja pa je le na recept.
English: • treatment with docetaxel (a cancer medicine) has not worked or no longer works; or
Slovenian: • zdravljenje z docetakselom (zdravilom proti raku) ni delovalo ali ne deluje več ali
English: Why is Xtandi authorised in the EU?
Slovenian: Zakaj je zdravilo Xtandi odobreno v EU?
English: As for all medicines, data on the use of Xtandi are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Xtandi stalno spremljajo.
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.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Xtandi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
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).
Slovenian: Drugi pomembni neželeni učinki so padci, kognitivna motnja (težave z razmišljanjem, učenjem in spominom) in nevtropenija (nizke ravni nevtrofilcev, vrste belih krvnih celic).
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).
Slovenian: Najpogostejši neželeni učinki zdravila Xtandi (ki lahko prizadenejo več kot 1 osebo od 10) so utrujenost, zlomi kosti, vročinski oblivi in hipertenzija (visok krvni tlak).
English: An overview of Xtandi and why it is authorised in the EU
Slovenian: Pregled zdravila Xtandi in zakaj je odobreno v EU