FrancophonIA/ELRC3.0 huggingface dataset:
English: Men should use effective contraceptive measures and be advised to not father a child while receiving Dacogen, and for 3 months following completion of treatment (see section 5.3).
Danish: Mænd bør anvende sikker kontraception, og de bør rådes til ikke at gøre en kvinde gravid, mens de får Dacogen og i op til 3 måneder efter afsluttet behandling (se pkt.
English: Dacogen was administered as a 1-hour intravenous infusion of 20 mg/m2 once daily for 5 consecutive days repeated every 4 weeks.
Danish: Dacogen blev administreret over 1 time som intravenøs infusion af 20 mg/m2 en gang dagligt 5 dage i træk hver 4. uge.
English: After preparing the medicine, it contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium- free'.
Danish: Efter klargøring af lægemidlet indeholder det mindre end 1 mmol (39 mg) kalium pr. dosis, dvs. det kan anses som værende ”kaliumfrit”.
English: Dacogen is contraindicated during breast-feeding; therefore, if treatment with this medicine is required, breast-feeding must be discontinued (see section 4.3).
Danish: Dacogen er kontraindiceret under amning, og hvis behandling med dette lægemiddel skønnes nødvendig, bør amningen ophøre (se pkt.
English: Skin contact with the solution should be avoided and protective gloves must be worn.
Danish: Undgå, at huden kommer i kontakt med opløsningen - anvend beskyttelseshandsker.
English: How Dacogen is given The solution is given into a vein (as an infusion).
Danish: Sådan gives Dacogen Opløsningen gives som drop (infusion) i en vene.
English: After reconstitution and dilution of the solution for intravenous infusion, this medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium- free'.
Danish: Efter rekonstitution og fortynding af opløsningen til intravenøs infusion indeholder dette lægemiddel mindre end 1 mmol (39 mg) kalium pr. dosis, dvs. det kan anses som værende ”kaliumfrit”.
English: HR (95% CI): 0.85 (0.69, 1.04) Logrank p-value: 0.1079
Danish: HR (95 % CI): 0,85 (0,69, 1,04) Logrank p-værdi: 0,1079
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (kan berøre op til 1 ud af 10 personer):
English: Complete blood and platelet counts should be performed regularly, as clinically indicated and prior to each treatment cycle.
Danish: Fuld blodstatus og trombocyttal bør bestemmes regelmæssigt i henhold til klinisk behov og før hver behandlingscyklus.
English: In non-clinical animal studies, decitabine alters male fertility and is mutagenic.
Danish: I prækliniske dyrestudier påvirkede decitabin fertiliteten hos handyr og var mutagent.
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.
Danish: Efter markedsføring er der rapporteret om kardiomyopati med hjertedekompensation, som i nogle tilfælde var reversibel efter seponering af behandlingen, reduktion af dosis eller korrigerende behandling.
English: Unopened vial: Do not store above 25C.
Danish: Uåbnet hætteglas: Må ikke opbevares ved temperaturer over 25 °C.
English: Posology In a treatment cycle, Dacogen is administered at a dose of 20 mg/m body surface area by intravenous infusion over 1 hour repeated daily for 5 consecutive days (i.e., a total of 5 doses per treatment cycle).
Danish: Dosering I en behandlingscyklus administreres Dacogen i en dosis på 20 mg/m2 legemsoverflade som intravenøs infusion over 1 time, hvilket gentages dagligt 5 dage i træk (dvs. i alt 5 doser pr. behandlingscyklus).
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.
Danish: Behandling af myelosuppression og tilstødende komplikationer Myelosuppression og bivirkninger relateret til myelosuppression (trombocytopeni, anæmi, neutropeni og febril neutropeni) ses hyppigt hos både behandlede og ubehandlede patienter med AML.
English: HR (95% CI): 0.82 (0.68, 0.99) Logrank p-value: 0.0373
Danish: HR (95 % CI): 0,82 (0,68, 0,99) Logrank p-værdi: 0,0373
English: Uncommon acute febrile neutrophilic dermatosis (Sweet's syndrome)
Danish: Hud og subkutane væv Ikke almindelig akut febril neutrofil dermatose (Sweets syndrom)
English: Including preferred terms hypersensitivity, drug hypersensitivity, anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock.
Danish: Inklusive foretrukne termer for overfølsomhed, lægemiddeloverfølsomhed, anafylaktisk reaktion, anafylaktisk chok, anafylaktoid reaktion, anafylaktoidt chok.
English: Excipients with known effect Each vial contains 0.5 mmol potassium (E340) and 0.29 mmol sodium (E524).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hvert hætteglas indeholder 0,5 mmol kalium (E340) og 0,29 mmol natrium (E524).
English: The time period following treatment with Dacogen where it is safe to become pregnant is unknown.
Danish: Det vides ikke, hvor længe der bør gå efter behandling med Dacogen, før det er sikkert at blive gravid.
English: • Haemorrhage (gastrointestinal, genito-urinary, pulmonary with platelets < 25,000/µL or any central nervous system haemorrhage)
Danish: • Blødning (gastrointestinal, urogenital eller pulmonal blødning med trombocyttal < 25.000/µl eller en blødning i centralnervesystemet)
English: Overall survival (ITT population).
Danish: Figur 1 Samlet overlevelse (ITT-populationen)
English: For a typical patient (weight 70 kg/body surface area 1.73 m2) the decitabine pharmacokinetic parameters are listed in the Table 3 below.
Danish: Decitabins PK parametre for en typisk patient (vægt 70 kg/legemsoverflade 1,73 m2) fremgår af tabel 3 nedenfor.
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.
Danish: Der er blevet indberettet tilfælde af interstitiel lungesygdom (ILS) (herunder lungeinfiltrater, organiserende pneumoni og lungefibrose) uden tegn på infektiøs ætiologi hos patienter, der får decitabin.
English: No formal clinical drug interaction studies with decitabine have been conducted.
Danish: Der er ikke udført formelle kliniske interaktionsstudier med decitabin.
English: (body surface area).
Danish: (legemsoverflade).
English: Other side effects of Dacogen include
Danish: Andre bivirkninger ved Dacogen:
English: The most common Grade 3/4 adverse drug reactions (≥ 20%) included pneumonia, thrombocytopaenia, neutropaenia, febrile neutropaenia and anaemia.
Danish: De mest almindelige bivirkninger af grad 3/4 (≥ 20 %) omfattede pneumoni, trombocytopeni, neutropeni, febril neutropeni og anæmi.
English: This medicine contains 0.5 mmol potassium per vial.
Danish: Dette lægemiddel indeholder 0,5 mmol kalium pr. hætteglas.
English: Thus; CYP-mediated metabolic drug interactions are not anticipated, and decitabine is unlikely to interact with agents metabolized through these pathways.
Danish: CYP-medierede lægemiddelinteraktioner forventes derfor ikke, og det er usandsynligt, at der vil forekomme interaktion mellem decitabin og lægemidler, der omdannes via dette system.
English: • The active substance is decitabine.
Danish: • Aktivt stof: decitabin.
English: • a serious kidney disorder,
Danish: • har en alvorlig nyresygdom,
English: Tell your doctor or nurse immediately if you notice any of the serious side effects above.
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis du bemærker en af disse alvorlige bivirkninger.
English: • This medicine contains 0.5 mmol potassium in each vial.
Danish: • Dette lægemiddel indeholder 0,5 mmol kalium i hvert hætteglas.
English: • abnormal liver function
Danish: • unormal leverfunktion.
English: The adverse drug reactions are listed by frequency category.
Danish: Bivirkningerne er opstillet efter hyppighed.
English: Uncommon Cardiomyopathy
Danish: Ikke almindelig kardiomyopati
English: After reconstitution, 1 ml concentrate contains 5 mg decitabine.
Danish: Efter rekonstitution indeholder 1 ml koncentrat 5 mg decitabin.
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.
Danish: Den tilberedte og fortyndede opløsning til intravenøs infusion kan maksimalt opbevares i 3 timer ved 2 °C - 8 °C efterfulgt af op til 1 time ved stuetemperatur (20 °C - 25 °C) før administration.
English: The need for dose adjustment in patients with hepatic impairment has not been evaluated.
Danish: Behovet for dosisjustering hos patienter med nedsat leverfunktion er ikke evalueret.
English: Male and female fertility and contraception
Danish: Frugtbarhed og prævention til mænd og kvinder
English: Powder for concentrate for solution for infusion (powder for infusion).
Danish: Pulver til koncentrat til infusionsvæske, opløsning (pulver til infusionsvæske).
English: 9 subjects received cytarabine 1 g/m 2 and 8 subjects received cytarabine administered at the maximum tolerable dose of 2 g/m2.
Danish: I dette studie blev der sammenlagt inkluderet 17 forsøgspersoner, som fik Dacogen 20 mg/m hvoraf 9 forsøgspersoner fik cytarabin 1 g/m2 og 8 forsøgspersoner fik den maksimalt tolererede dosis på 2 g/m2 cytarabin.
English: Adverse drug reactions reported in 293 AML patients treated with Dacogen are summarised in Table 1.
Danish: Tabel 1 viser de bivirkninger, der forekom hos 293 patienter med AML under behandling med Dacogen.
English: Other medicines and Dacogen
Danish: Brug af anden medicin sammen med Dacogen
English: It is supplied in a 20 ml glass vial containing 50 mg decitabine.
Danish: Det udleveres i et 20 ml hætteglas, der indeholder 50 mg decitabin.
English: Janssen-Cilag AB Tel: +46 8 626 50 00
Danish: Janssen-Cilag AB Tfn: +46 8 626 50 00
English: Population PK analysis of decitabine showed that after accounting for body size, there is no difference between decitabine PK parameters in paediatric AML patients versus adults with AML or MDS.
Danish: Populationsfarmakokinetisk analyse af decitabin påviste, at der ikke er nogen forskelle i decitabins farmakokinetiske parametre for pædiatriske patienter med AML kontra voksne med AML eller MDS, når der er taget højde for legemsstørrelse.
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.
Danish: Progressionsfri overlevelse var signifikant længere hos forsøgspersoner i Dacogen-gruppen: 3,7 måneder (95 % CI: 2,7; 4.6) sammenlignet med forsøgspersoner i TC-gruppen: 2,1 måneder (95 % CI: 1,9; 3,1); hazard ratio 0,75 (95 % CI: 0,62, 0,91), p = 0,0031.
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).
Danish: Der skal udføres nyrefunktionstest inden påbegyndelse af behandlingen og inden de enkelte behandlingscyklusser samt som klinisk indiceret (se pkt.
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.
Danish: Inden for 15 minutter efter rekonstitution skal opløsningen fortyndes yderligere med kold infusionsvæske (9 mg/ml [0,9 %] natriumchlorid injektionsvæske eller 5 % glukoseopløsning til injektion) til en endelig koncentration på 0,15 til 1,0 mg/ml.
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.
Danish: Den fremstillede, fortyndede opløsning kan opbevares i køleskab (2 °C - 8 °C) i op til maksimalt 3 timer efterfulgt af op til 1 time ved stuetemperatur (20 °C - 25 °C) før anvendelse.
English: After reconstitution with 10 ml of water for injections, each ml of concentrate contains 5 mg of decitabine.
Danish: Efter rekonstitution med 10 ml vand til injektionsvæsker indeholder 1 ml koncentrat 5 mg decitabin.
English: All subjects discontinued the study treatment.
Danish: Forsøgsbehandlingen blev seponeret hos alle forsøgspersoner.
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.
Danish: Inden for 15 minutter efter rekonstitutionen skal opløsningen fortyndes yderligere med kold (2 °C - 8 °C) infusionsvæske (natriumchlorid 9 mg/ml [0,9 %] injektionsvæske eller 5 % glukoseopløsning til injektion) til en endelig koncentration på 0,15 til 1,0 mg/ml.
English: The need for dose adjustment in patients with renal impairment has not been evaluated (see section 4.4 and 5.2).
Danish: Behovet for dosisjustering hos patienter med nedsat nyrefunktion er ikke evalueret (se pkt.
English: What Dacogen looks like and contents of the pack Dacogen is a white to almost white powder for concentrate for solution for infusion.
Danish: Dacogen er et hvidt til næsten hvidt pulver til koncentrat til infusionsvæske, opløsning.
English: Very common diarrhoea vomiting nausea Common stomatitis Not known enterocolitis, including neutropaenic colitis, caecitis*
Danish: Ikke kendt enterocolitis, herunder neutropen colitis, caecitis*
English: How to use Dacogen
Danish: Sådan skal du bruge Dacogen
English: Potassium dihydrogen phosphate (E340) Sodium hydroxide (E524) Hydrochloric acid (for pH adjustment)
Danish: Kaliumdihydrogenphosphat (E340) Natriumhydroxid (E524) Saltsyre (til justering af pH)
English: This is because it is not known if the medicine passes into the mother's milk.
Danish: • Du må ikke amme, mens du får Dacogen, da det ikke vides, om medicinen går over i modermælken.
English: The most commonly reported haematologic adverse drug reactions associated with Dacogen treatment included febrile neutropaenia, thrombocytopaenia, neutropaenia, anaemia and leukopaenia.
Danish: De hyppigst indberettede hæmatologiske bivirkninger forbundet med Dacogen-behandling omfattede febril neutropeni, trombocytopeni, neutropeni, anæmi og leukopeni.
English: What Dacogen contains
Danish: Dacogen indeholder:
English: • mouth or tongue ulcers
Danish: • sår i munden eller på tungen
English: Reconstitution procedure
Danish: Rekonstitutionsmetode
English: The most common adverse drug reactions (≥ 35%) reported are pyrexia, anaemia and thrombocytopaenia.
Danish: Resumé af sikkerhedsprofilen De mest almindelige bivirkninger (≥ 35 %), som er rapporteret, er pyreksi, anæmi og trombocytopeni.
English: The PK of decitabine have not been formally studied in patients with renal insufficiency.
Danish: Decitabins PK er ikke formelt undersøgt hos patienter med nedsat nyrefunktion.
English: Uncommon pancytopaenia*
Danish: Ikke almindelig pancytopeni
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).
Danish: Der skal udføres leverfunktionstest inden påbegyndelse af behandlingen og inden de enkelte behandlingscyklusser samt som klinisk indiceret (se pkt.
English: The PK of decitabine have not been formally studied in patients with hepatic impairment.
Danish: Decitabins PK er ikke formelt undersøgt hos patienter med nedsat leverfunktion.
English: Frequency All Grades
Danish: Alle grader
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).
Danish: Median samlet overlevelse i ITT-populationen var 7,7 måneder hos forsøgspersoner, der fik Dacogen, sammenlignet med 5,0 måneder hos forsøgspersoner i TC-gruppen (hazard ratio 0,85; 95 % CI: 0,69, 1,04, p = 0,1079).
English: Hypersensitivity to decitabine or to any of the excipients, listed in section 6.1.
Danish: Overfølsomhed over for decitabin eller over for et eller flere af hjælpestofferne anført i pkt.
English: Decitabine administration to neonatal/juvenile rats showed a comparable general toxicity profile as in older rats.
Danish: Generel toksicitet efter administration af decitabin var sammenlignelig hos neonatale/juvenile rotter og ældre rotter.
English: • liver disease,
Danish: • har en leversygdom,
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.
Danish: Ud fra den indledende analyse af ITT-populationen blev der opnået en statistisk signifikant forskel i komplet remission (CR + CRp) til fordel for forsøgspersonerne i Dacogen-gruppen, 17,8 % (43/242) sammenlignet med TC-gruppen, 7,8 % (19/243).
English: You will have blood tests before you start treatment with Dacogen and at the start of each treatment cycle.
Danish: Før du begynder på behandling med Dacogen og ved starten på hver cyklus, skal du have udført en række blodprøver.
English: What Dacogen is and what it is used for What you need to know before you use Dacogen How to use Dacogen
Danish: Det skal du vide, før du begynder at bruge Dacogen Sådan skal du bruge Dacogen Bivirkninger
English: • The other ingredients are potassium dihydrogen phosphate (E340), sodium hydroxide(E524), and hydrochloric acid (for pH-adjustment).
Danish: • Øvrige indholdsstoffer: kaliumdihydrogenphosphat (E340), natriumhydroxid (E524) og saltsyre (til pH-justering).
English: • your liver and kidneys are working properly.
Danish: • at din lever- og nyrefunktion er i orden.
English: Dacogen 50 mg powder for infusion decitabine
Danish: Dacogen 50 mg pulver til infusionsvæske decitabin i.v.
English: Excipients: potassium dihydrogen phosphate (E340), sodium hydroxide (E524), and hydrochloric acid.
Danish: Hjælpestoffer: kaliumdihydrogenphosphat (E340), natriumhydroxid (E524) og saltsyre.
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, pyrimidine analogues; ATC Code: L01BC08
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, antimetabolitter, pyrimidinanaloger.
English: • sore or runny nose, sore sinuses
Danish: • ømhed i næsen eller snue, ømhed i bihulerne
English: Very common epistaxis Not known interstitial lung disease
Danish: Ikke kendt interstitiel lungesygdom Ikke kendt
English: Very common febrile neutropaenia* neutropaenia* thrombocytopaenia*
Danish: Blod og lymfesystem Meget almindelig febril neutropeni neutropeni trombocytopeni
English: Decitabine Vdss in cancer patients is large indicating distribution into peripheral tissues.
Danish: hvilket indikerer fordeling til perifere væv.
English: This may be a sign of bleeding in the stomach or gut (common).
Danish: Det kan være tegn på blødning i mave eller tarm (almindelig).
English: Thus, decitabine exposure is not likely to be affected in patients with impaired hepatic function.
Danish: Eksponeringen for decitabin vil således næppe være påvirket hos patienter med nedsat leverfunktion.
English: Serious infection-related adverse drug reactions, with potentially fatal outcome, such as septic shock, sepsis, pneumonia, and other infections (viral, bacterial and fungal) were reported in patients receiving decitabine.
Danish: Bivirkninger i form af infektioner og parasitære sygdomme Hos patienter, der fik decitabin, er der rapporteret om alvorlige bivirkninger forbundet med infektioner, der potentielt kan være fatale, så som septisk chok, sepsis, pneumoni og andre infektioner (af viral, bakteriel eller mykotisk oprindelse).
English: Dacogen 50 mg powder for concentrate for solution for infusion decitabine
Danish: Dacogen 50 mg pulver til koncentrat til infusionsvæske, opløsning decitabin
English: What you need to know before you are given Dacogen
Danish: Det skal du vide, før du begynder at bruge Dacogen
English: Dacogen 50 mg powder for concentrate for solution for infusion.
Danish: Dacogen 50 mg pulver til koncentrat til infusionsvæske, opløsning.
English: RECONSTITUTION
Danish: REKONSTITUTION
English: Each vial contains 50 mg decitabine.
Danish: Et hætteglas indeholder 50 mg decitabin.
English: Very common hyperglycaemia
Danish: Metabolisme og ernæring Meget almindelig hyperglykæmi
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution og fortynding af lægemidlet, se pkt.
English: Thus, decitabine exposure is not likely to be affected in patients with impaired renal function.
Danish: Eksponeringen for decitabin vil således næppe være påvirket hos patienter med nedsat nyrefunktion.
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.
Danish: Efter klargøring af lægemidlet indeholder det mellem 13,8 mg og 138 mg natrium pr. dosis.
English: Studies in patients with renal impairment have not been conducted.
Danish: Der er ikke udført studier af patienter med nedsat leverfunktion.
English: Each vial of powder for concentrate for solution for infusion contains 50 mg decitabine.
Danish: Et hætteglas med pulver til koncentrat til infusionsvæske, opløsning indeholder 50 mg decitabin.
English: Each vial of powder contains 50 mg decitabine.
Danish: Et hætteglas med pulver indeholder 50 mg decitabin.
English: Use in patients with severe renal impairment has not been studied.
Danish: Anvendelse til patienter med svært nedsat nyrefunktion er ikke klarlagt.
English: Cardiac disease
Danish: Mave-tarmsygdomme
English: This is because Dacogen can affect the way some other medicines work.
Danish: Dacogen kan påvirke behandlingen med anden medicin, og/eller anden medicin kan påvirke behandlingen med Dacogen.
English: Very common hepatic function abnormal Common hyperbilirubinaemia
Danish: Almindelig hyperbilirubinæmi
English: For the shelf-life and the precautions for storage after reconstitution, see section 5 of the leaflet.
Danish: Se opbevaringsbetingelser og opbevaringstid efter rekonstitution i pkt.
English: Studies in patients with hepatic impairment have not been conducted.
Danish: Der er ikke udført studier af patienter med nedsat nyrefunktion.
English: • feeling tired or looking pale - these may be signs of a drop in the number of red blood cells
Danish: Det kan være tegn på et fald i antallet af røde blodlegemer
English: • bleeding or bruising more easily - these may be signs of a drop in the number of blood platelets
Danish: Det kan være tegn på et fald i antallet af blodplader
English: Use in patients with hepatic impairment has not been established.
Danish: Anvendelse til patienter med nedsat leverfunktion er ikke klarlagt.
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).
Danish: I en analyse med yderligere 1 års modne overlevelsesdata viste Dacogens påvirkning af den samlede overlevelse en klinisk forbedring sammenlignet med TC-gruppen (henholdsvis 7,7 måneder vs.
English: No. of Subjects at Risk DACOGEN Total TC
Danish: Antal forsøgspersoner i risikogruppen DACOGEN
English: • an infection of the blood caused by bacteria - this may be a sign of a low level of white blood cells
Danish: Det kan være tegn på et lavt antal hvide blodlegemer.
English: Renal impairment
Danish: Almindelig stomatit
English: Xtandi received a marketing authorisation valid throughout the EU on 21 June 2013.
Danish: Xtandi fik en markedsføringstilladelse med gyldighed i hele EU den 21. juni 2013.