FrancophonIA/ELRC3.0 huggingface dataset:
English: - If you are allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Xtandi: hvis du er allergisk over for enzalutamid eller et af de øvrige indholdsstoffer i Xtandi (angivet i punkt 6).
English: Median PFS was 19.4 months (95% CI: 16.5, not reached) in the enzalutamide group versus 5.7 months (95% CI: 5.6, 8.1) in the bicalutamide group [HR = 0.24 (95% CI: 0.18, 0.32), p < 0.0001].
Danish: Median PFS var 19,4 måneder (95 % KI: 16,5, ikke nået) i enzalutamidgruppen mod 5,7 måneder (95 % KI: 5,6, 8,1) i bicalutamidgruppen [HR = 0,24 (95 % KI: 0,18, 0,32, p < 0,0001].
English: Astellas Pharma Puh/Tel: +358 (0)9 85606000
Danish: Suomi/Finland Astellas Pharma Puh/Tel: + 358 (0)9 85606000
English: In a phase 3 clinical trial (AFFIRM) of patients who failed prior chemotherapy with docetaxel, 54% of patients treated with enzalutamide, versus 1.5% of patients who received placebo, had at least a 50% decline from baseline in PSA levels.
Danish: I et klinisk fase 3-studie (AFFIRM) med patienter, som ikke havde gavn af tidligere kemoterapi med docetaxel, faldt PSA-niveauerne mindst 50 % i forhold til baseline hos 54 % af patienterne behandlet med enzalutamid i forhold til 1,5 % af patienterne på placebo.
English: MDV3100-09 (STRIVE) study (chemotherapy-naïve patients with non-metastatic/metastatic CRPC)
Danish: MDV3100-09 (STRIVE)-studiet (kemoterapi-naive patienter med non-metastatisk/metastatisk CRPC)
English: The median rPFS was not reached (95% CI: 13.8, not reached) in the enzalutamide-treated group and was 3.9 months (95% CI: 3.7, 5.4) in the placebotreated group (Figure 6).
Danish: Den mediane rPFS blev ikke nået (95 % KI: 13,8; ikke nået) i enzalutamidgruppen og var 3,9 måneder (95 % KI: 3,7; 5,4) i placebogruppen
English: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 14 film-coated tablets.
Danish: Paptegnebog indeholdende en PVC/PCTFE/aluminium-blister med 14 filmovertrukne tabletter.
English: Headache, fall, feeling anxious, dry skin, itching, difficulty remembering, blockage of the arteries in the heart (ischemic heart disease), breast enlargement in men (gynaecomastia), symptom of restless legs syndrome (an uncontrollable urge to move a part of the body, usually the leg), reduced concentration, forgetfulness
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer) Hovedpine, fald, ængstelse, tør hud, kløe, hukommelsesbesvær, blokering af arterierne i hjertet (iskæmisk hjertesygdom), brystforstørrelse hos mænd (gynækomasti), symptomer på ”restless legs”-syndrom eller uro i benene (en ukontrollabel trang til at bevæge en del af kroppen, sædvanligvis et ben), koncentrationsbesvær, glemsomhed
English: Tell your doctor if you are taking any of the medicines listed above.
Danish: Fortæl altid lægen, hvis du tager nogen af ovennævnte former for medicin.
English: This medicine may cause harm to the unborn child or potential loss of pregnancy if taken by women who are pregnant (see sections 4.3, 5.3, and 6.6).
Danish: Dette lægemiddel kan forårsage skade på det ufødte barn eller potentielt abort, hvis det tages af gravide kvinder (se pkt.
English: Taking Xtandi
Danish: Sådan tages Xtandi
English: - Xtandi soft capsules are white to off-white, oblong soft capsules (approximately 20 mm by
Danish: Xtandi bløde kapsler er hvide til offwhite, aflange, bløde kapsler (ca. 20 mm x 9 mm) præget med "ENZ" på den ene side.
English: A total of 1717 asymptomatic or mildly symptomatic chemotherapy-naïve patients were randomised 1:1 to receive either enzalutamide orally at a dose of 160 mg once daily (N = 872) or placebo orally once daily (N = 845).
Danish: I alt 1.717 kemoterapi-naive patienter, som var asymptomatiske eller havde lette symptomer, blev randomiseret 1:1 til at få enten 160 mg enzalutamid oralt én gang dagligt (N = 872) eller placebo oralt én gang dagligt (N = 845).
English: Each carton contains 112 film-coated tablets (4 wallets).
Danish: Hver æske indeholder 112 filmovertrukne tabletter (4 tegnebøger).
English: Radiographic progression-free survival as assessed by the investigator using RECIST v 1.1 for soft tissue and appearance of 2 or more bone lesions in bone scan was 8.3 months for patients treated with enzalutamide and 2.9 months for patients who received placebo [HR = 0.40 (95% CI: 0.35, 0.47), p < 0.0001].
Danish: Radiografisk progressionsfri overlevelse som vurderet af investigatoren ved anvendelse af RECIST v1.1 for bløddele og forekomst af 2 eller flere knoglelæsioner ved knoglescanning var 8,3 måneder for patienter behandlet med enzalutamid og 2,9 måneder for patienter, som modtog placebo [HR = 0,40 (95 % KI: 0,35, 0,47), p <0,0001].
English: Xtandi - 40 mg soft capsules Each soft capsule contains 40 mg of enzalutamide.
Danish: Xtandi - 40 mg bløde kapsler Hver blød kapsel indeholder 40 mg enzalutamid.
English: MDV3100-03 (PREVAIL) study (chemotherapy-naïve patients with metastatic CRPC)
Danish: MDV3100-03 (PREVAIL)-studiet (kemoterapi-naive patienter med metastatisk CRPC)
English: Median time to first use of new antineoplastic therapy was 39.6 months (95% CI: 37.7, NR) on the enzalutamide arm versus 17.7 months (95% CI: 16.2, 19.7) on the placebo arm.
Danish: Mediantid til første brug af ny antineoplastisk behandling var 39,6 måneder (95 % KI: 37,7, NR) i enzalutamidarmen mod 17,7 måneder (95 % KI: 16,2, 19,7) i placeboarmen.
English: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 28 film-coated tablets.
Danish: Paptegnebog indeholdende en PVC/PCTFE/aluminium-blister med 28 filmovertrukne tabletter.
English: Xtandi - 40 mg film-coated tablets Xtandi - 80 mg film-coated tablets
Danish: Xtandi - 40 mg filmovertrukne tabletter Xtandi - 80 mg filmovertrukne tabletter
English: Posology The recommended dose is 160 mg enzalutamide (four 40 mg soft capsules) as a single oral daily dose.
Danish: Den anbefalede dosering er 160 mg enzalutamid (fire 40 mg bløde kapsler) som en daglig oral enkeltdosis.
English: Enzalutamide demonstrated a statistically significant delay in the time to first use of new antineoplastic therapy compared to placebo [HR = 0.21 (95% CI: 0.17, 0.26), p < 0.0001].
Danish: Enzalutamid viste en statistisk signifikant forsinkelse i tiden til første brug af ny antineoplastisk behandling sammenlignet med placebo [HR = 0,21 (95 % KI: 0,17, 0,26, p < 0,0001].
English: The active substance is enzalutamide.
Danish: Aktivt stof: Enzalutamid.
English: There have been rare reports of PRES (may affect up to 1 in 1,000 people), a rare, reversible condition involving the brain, in patients treated with Xtandi.
Danish: Posteriort reversibelt encefalopati-syndrom (PRES) Der har været sjældne rapporter (kan forekomme hos 1 ud af 1.000 personer) om patienter i behandling med Xtandi, som har fået PRES, en sjælden, reversibel sygdom, der rammer hjernen.
English: Number of Events (%) Median, months (95% CI)1
Danish: Median, måneder (95 % KI)1
English: Figure 4: Kaplan-Meier curves of overall survival based on updated survival analysis in the PREVAIL study (intent-to-treat analysis)
Danish: Figur 4: Kaplan-Meier-kurver for samlet overlevelse baseret på opdateret overlevelsesanalyse i PREVAIL-studiet (intent-to-treat-analyse)
English: A total of 1199 patients were randomised 2:1 to receive either enzalutamide orally at a dose of 160 mg once daily (N = 800) or placebo once daily (N = 399).
Danish: I alt 1.199 patienter blev randomiseret i forholdet 2:1 til at modtage enten enzalutamid oralt i en dosis på 160 mg én gang dagligt (N = 800) eller placebo én gang dagligt (N = 399).
English: Patient demographics and baseline disease characteristics were balanced between the treatment arms.
Danish: Patientdemografi og sygdomskarakteristika ved baseline var afbalanceret mellem de 2 arme.
English: Tell your doctor if you are taking the following medicines.
Danish: Fortæl altid lægen, hvis du tager følgende former for medicin.
English: A pre-specified follow-up rPFS analysis based on the investigator assessment of radiographic progression demonstrated a statistically significant improvement between the treatment groups with a 69.3% reduction in risk of radiographic progression or death [HR = 0.31 (95% CI: 0.27, 0.35), p < 0.0001].
Danish: En forudspecificeret rPFSopfølgningsanalyse baseret på investigators vurdering af radiografisk progression viste en statistisk signifikant forbedring mellem behandlingsgrupperne med 69,3 % reduktion i risiko for radiografisk progression eller død [HR = 0,31 (95 % KI: 0,27; 0,35), p < 0,0001].
English: Following oral administration of the strong CYP3A4 inhibitor itraconazole (200 mg once daily) to healthy male subjects, the AUC of enzalutamide increased by 41% while Cmax was unchanged.
Danish: Efter oral administration af den kraftige CYP3A4-hæmmer itraconazol (200 mg én gang dagligt) til raske mandlige forsøgspersoner blev AUC for enzalutamid forøget med 41 %, mens Cmax var uændret.
English: Do not stop taking this medicine unless your doctor tells you to.
Danish: Hvis du holder op med at tage Xtandi Du må ikke holde op med at tage dette lægemiddel, medmindre lægen beder dig om det.
English: Following oral administration of the moderate CYP2C8 and strong CYP3A4 inducer rifampin (600 mg once daily) to healthy male subjects, the AUC of enzalutamide plus the active metabolite decreased by 37% while Cmax remained unchanged.
Danish: Efter oral administration af den moderate CYP2C8- og kraftige CYP3A4-induktor rifampin (600 mg én gang dagligt) til raske mandlige forsøgspersoner blev AUC af enzalutamid plus den aktive metabolit reduceret med 37 %, mens Cmax forblev uændret.
English: Each capsule contains 40 mg enzalutamide.
Danish: Hver kapsel indeholder 40 mg enzalutamid.
English: Baseline pain assessment was 0 - 1 (asymptomatic) in 67% of patients and 2 - 3 (mildly symptomatic) in 32% of patients as defined by the Brief Pain Inventory Short Form (worst pain over past 24 hours on a scale of 0 to 10).
Danish: Smerte vurderet ved hjælp af Brief Pain Inventory Short Form (værste smerte i løbet af de seneste 24 timer på en skala fra 0 til 10) var ved baseline 0-1 (asymptomatisk) hos 67 % af patienterne og 2-3 (let symptomatisk) hos 32 % af patienterne.
English: Patients receiving enzalutamide demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 78.0% versus 3.5% (difference = 74.5%, p < 0.0001).
Danish: Patienter, der fik enzalutamid, viste en signifikant højere total PSA-responsrate (defineret som ≥ 50 % reduktion fra baseline) sammenlignet med patienter, der fik placebo, 78,0 % versus 3,5 % (forskel = 74,5 %, p < 0,0001).
English: Not known (frequency cannot be estimated from the available data) Muscle pain, muscle spasms, muscular weakness, back pain, changes in ECG (QT prolongation), upset stomach including feeling sick (nausea), rash, being sick (vomiting), swelling of the face, lips, tongue and/or throat, reduction in blood platelets (which increases risk of bleeding or bruising), diarrhoea
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data) Muskelsmerter, muskelkramper, muskelsvaghed, rygsmerter, ændringer i EKG (QTforlængelse), maveproblemer herunder kvalme, udslæt, opkastning, hævelse af ansigtet, læber,
English: Median time to PSA progression was 37.2 months (95% CI: 33.1, NR) on the enzalutamide arm versus 3.9 months (95% CI: 3.8, 4.0) on the placebo arm.
Danish: Median tid til PSAprogression var 37,2 måneder (95 % KI: 33,1, NR) i enzalutamidarmen mod 3,9 måneder (95 % KI: 3,8, 4,0) i placeboarmen.
English: The AFFIRM study excluded patients with medical conditions that may predispose them to seizures (see section 4.8) and medicinal products known to decrease the seizure threshold, as well as clinically significant cardiovascular disease such as uncontrolled hypertension, recent history of myocardial infarction or unstable angina, New York Heart Association class III or IV heart failure (unless ejection fraction was ≥ 45%), clinically significant ventricular arrhythmias or AV block (without permanent pacemaker).
Danish: 4.8) og anvendelse af lægemidler, der vides at sænke krampetærsklen, samt klinisk signifikant kardiovaskulær sygdom, såsom ukontrolleret hypertension, nyligt overstået myokardieinfarkt eller ustabil angina pectoris, hjerteinsufficiens i New York Heart Association-klasse III eller IV (medmindre ejektionsfraktionen var ≥45 %), klinisk signifikante ventrikulære arytmier eller AV-blok (uden permanent pacemaker), blev udelukket fra AFFIRM-studiet.
English: At the pre-specified rPFS analysis, a statistically significant improvement was demonstrated between the treatment groups with an 81.4% reduction in risk of radiographic progression or death [HR = 0.19 (95% CI: 0.15, 0.23), p < 0.0001].
Danish: Den forudspecificerede rPFS-analyse viste en statistisk signifikant forbedring mellem behandlingsgrupperne med en 81,4 % reduktion i risiko for radiografisk progression eller død [HR = 0,19 (95 % KI: 0,15, 0,23), p < 0,0001].
English: Xtandi contains sorbitol (E420).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder sorbitol (E 420).
English: What you need to know before you take Xtandi Do not take Xtandi:
Danish: Det skal du vide, før du begynder at tage Xtandi Sådan skal du tage Xtandi Bivirkninger
English: Food has no clinically significant effect on the extent of exposure to enzalutamide.
Danish: Virkningen af fødeindtagelse på enzalutamideksponeringen Mad har ingen klinisk signifikant virkning på graden af eksponering for enzalutamid.
English: Concomitant use of enzalutamide with medicinal products that are sensitive substrates of many metabolising enzymes or transporters (see section 4.5) should generally be avoided if their therapeutic effect is of large importance to the patient, and if dose adjustments cannot easily be performed based on monitoring of efficacy or plasma concentrations.
Danish: 4.5) bør generelt undgås, hvis den terapeutiske virkning har stor betydning for patienten og hvis der ikke nemt kan foretages dosisjusteringer på baggrund af monitorering af effekt eller plasmakoncentrationer.
English: Tell your doctor if you are taking any of the following medicines.
Danish: Fortæl altid lægen, hvis du tager nogen af følgende former for medicin.
English: Median MFS was 36.6 months (95% CI: 33.1, NR) on the enzalutamide arm versus 14.7 months (95% CI: 14.2, 15.0) on the placebo arm.
Danish: Median MFS var 36,6 måneder (95 % KI: 33,1, NR) i enzalutamidarmen mod 14,7 måneder (95 % KI: 14,2, 15,0) i placeboarmen.
English: Enzalutamide demonstrated a statistically significant 93% reduction in the relative risk of PSA progression compared to placebo [HR = 0.07 (95% CI: 0.05, 0.08), p < 0.0001].
Danish: Enzalutamid viste en statistisk signifikant reduktion på 93 % i den relative risiko for PSA-progression sammenlignet med placebo [HR = 0,07 (95 % KI: 0,05, 0,08), p < 0,0001].
English: Xtandi - 80 mg film-coated tablets Yellow oval - film-coated tablets, debossed with E 80.
Danish: Xtandi - 80 mg filmovertrukne tabletter Gule, ovale - filmovertrukne tabletter, præget med E 80.
English: Following oral administration of the strong CYP2C8 inhibitor gemfibrozil (600 mg twice daily) to healthy male subjects, the AUC of enzalutamide increased by 326% while Cmax of enzalutamide decreased by 18%.
Danish: Efter oral administration af den kraftige CYP2C8-hæmmer gemfibrozil (600 mg to gange dagligt) til raske mandlige forsøgspersoner blev AUC for enzalutamid forøget med 326 %, mens Cmax for enzalutamid faldt med 18 %.
English: Median PFS was 15.7 months for patients on enzalutamide versus 5.8 months for patients on bicalutamide [HR = 0.44 (95% CI: 0.34, 0.57), p < 0.0001].
Danish: Median PFS var 15,7 måneder for patienter behandlet med enzalutamid mod 5,8 måneder for patienter behandlet med bicalutamid [HR = 0,44 (95 % KI: 0,34; 0,57), p < 0,0001].
English: An increased half-life of enzalutamide has however been observed in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Der er imidlertid observeret en længere halveringstid for enzalutamid hos patienter med svært nedsat leverfunktion (se pkt.
English: Use of enzalutamide has been associated with seizure (see section 4.8).
Danish: Brug af enzalutamid har været forbundet med krampeanfald (se pkt.
English: Xtandi 40 mg film-coated tablets are yellow round film-coated tablets, debossed with E 40.
Danish: Xtandi 40 mg filmovertrukne tabletter er gule, runde, filmovertrukne tabletter, præget med E 40.
English: Figure 7: Kaplan-Meier curves of overall survival in the AFFIRM study (intent-to-treat analysis)
Danish: Figur 7: Kaplan-Meier-kurver for samlet overlevelse i AFFIRM-studiet (intent-to-treat-analyse)
English: In consideration of the long half-life of enzalutamide (5.8 days, see section 5.2), effects on enzymes may persist for one month or longer after stopping enzalutamide.
Danish: 5.2) kan virkninger på enzymer vare ved i en måned eller mere efter standsning af behandlingen med enzalutamid.
English: Enzalutamide demonstrated a statistically significant 71% reduction in the relative risk of radiographic progression or death compared to placebo [HR = 0.29 (95% CI: 0.24, 0.35), p < 0.0001].
Danish: Enzalutamid viste en statistisk signifikant reduktion på 71 % i den relative risiko for radiografisk progression eller død sammenlignet med placebo [HR = 0,29 (95 % KI: 0,24, 0,35), p < 0,0001].
English: Uncommon: leucopenia, neutropenia Not known*: thrombocytopenia
Danish: Blod og lymfesystem Ikke almindelig: Leukopeni, neutropeni Ikke kendt*: Trombocytopeni
English: Xtandi 40 mg soft capsules enzalutamide
Danish: Xtandi 40 mg bløde kapsler enzalutamid
English: Check with your doctor if you are not sure.
Danish: Spørg lægen, hvis der er noget, du er i tvivl om.
English: The median time to first skeletal-related event was 16.7 months for patients treated with enzalutamide and 13.3 months for patients who received placebo [HR = 0.69 (95% CI: 0.57, 0.84), p < 0.0001].
Danish: Mediantiden indtil første skeletrelaterede hændelse var 16,7 måneder for patienter behandlet med enzalutamid og 13,3 måneder for patienter, som modtog placebo [HR = 0,69 (95 % KI: 0,57, 0,84), p <0,0001].
English: In the MDV3100-09 clinical trial (STRIVE) of non-metastatic and metastatic CRPC, patients receiving enzalutamide demonstrated a significantly higher total confirmed PSA response rate (defined as a ≥ 50% reduction from baseline) compared with patients receiving bicalutamide, 81.3% versus 31.3% (difference = 50.0%, p < 0.0001).
Danish: I det kliniske studie MDV3100-009 (STRIVE) af ikke-metastatisk og metastatisk CRPC, viste patienter, der fik enzalutamid, en signifikant højere total bekræftet PSA-responsrate (defineret som ≥ 50 % reduktion fra baseline) sammenlignet med patienter, der fik bicalutamid, 81,3 % versus 31,3 % (forskel = 50,0 %, p < 0,0001).
English: In a phase 2 clinical trial (TERRAIN) in chemo-naïve patients, patients receiving enzalutamide demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving bicalutamide, 82.1% versus 20.9% (difference = 61.2%, p < 0.0001)
Danish: I et klinisk fase 2-studie (TERRAIN) med kemoterapi-naive patienter viste patienter, der fik enzalutamid, en signifikant højere total PSA-responsrate (defineret som ≥ 50 % reduktion fra baseline) sammenlignet med patienter, der fik bicalutamid, 82,1 % versus 20,9 % (forskel = 61,2 %, p < 0,0001).
English: Not known*: myalgia, muscle spasms, muscular weakness, back pain
Danish: Meget almindelig: Frakturer‡ Ikke kendt*: Myalgi, muskelkramper, muskelsvaghed, rygsmerter
English: Figure 6: Kaplan-Meier curves of radiographic progression-free survival in the PREVAIL study (intent-to-treat analysis)
Danish: Figur 6: Kaplan-Meier-kurver over radiografisk progressionsfri overlevelse i PREVAIL-studiet (intent-to-treat-analyse)
English: For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC and Cmax in subjects with mild impairment increased by 14% and 19%, respectively, the AUC and Cmax in subjects with moderate impairment increased by 14% and decreased by 17%, respectively, and the AUC and Cmax in subjects with severe hepatic impairment increased by 34% and decreased by 27%, respectively, compared to healthy control subjects.
Danish: For summen af ubundet enzalutamid plus den ubundne aktive metabolit steg AUC og Cmax hos forsøgspersoner med let nedsat leverfunktion med henholdsvis 14 % og 19 %, og AUC hos forsøgspersoner med moderat nedsat leverfunktion steg med 14 %, mens Cmax faldt med 17 %.
English: This includes certain medicines used to: - Lower cholesterol (e.g. gemfibrozil, atorvastatin, simvastatin) - Treat pain (e.g. fentanyl, tramadol) - Treat cancer (e.g. cabazitaxel) - Treat epilepsy (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid) - Treat certain psychiatric disorders such as severe anxiety or schizophrenia (e.g. diazepam,
Danish: Dette omfatter visse former for medicin, som anvendes til: sænkning af kolesterol (f.eks. gemfibrozil, atorvastatin, simvastatin) smertebehandling (f.eks. fentanyl, tramadol) kræftbehandling (f.eks. cabazitaxel) epilepsibehandling (f.eks. carbamazepin, clonazepam, phenytoin, primidon, valproinsyre) behandling af visse psykiatriske lidelser, som f.eks. svær angst eller skizofreni (f.eks. diazepam, midazolam, haloperidol)
English: In the MDV3100-14 clinical trial (PROSPER) of non-metastatic CRPC, patients receiving enzalutamide demonstrated a significantly higher confirmed PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 76.3% versus 2.4% (difference = 73.9%, p < 0.0001).
Danish: I det kliniske studie MDV3100-14 (PROSPER) af ikke-metastatisk CRPC, viste patienter, der fik enzalutamid, en signifikant højere bekræftet PSA-responsrate (defineret som ≥ 50 % reduktion fra baseline) sammenlignet med patienter, der fik placebo, 76,3 % versus 2,4 % (forskel = 73,9 %, p
English: Each soft capsule contains 40 mg of enzalutamide.
Danish: Hver blød kapsel indeholder 40 mg enzalutamid.
English: Deaths (%) Median survival (months) (95% CI)
Danish: Medianoverlevelse (måneder) (95 % KI)
English: Time to first use of new antineoplastic therapy
Danish: Tid til første brug af ny antineoplastisk behandling Antal hændelser ( %)
English: Talk to your doctor before taking Xtandi - If you are taking any medicines to prevent blood clots (e.g. warfarin, acenocoumarol,
Danish: Tal med lægen, inden du tager Xtandi hvis du tager medicin til forebyggelse af blodpropper (f.eks. warfarin, acenocoumarol, clopidogrel) hvis du får kemoterapi som f.eks. docetaxel hvis du har leverproblemer hvis du har nyreproblemer
English: If any of the above applies to you or you are not sure, talk to your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager dette lægemiddel, hvis noget af ovenstående gælder for dig, eller hvis du er usikker.
English: - Do not cut, crush or chew the tablets before swallowing.
Danish: Tabletterne må ikke deles, knuses eller tygges, før de synkes.
English: Children and adolescents
Danish: UTILGÆNGELIGT FOR BØRN
English: How to take Xtandi
Danish: Sådan skal du tage Xtandi
English: Enzalutamide is poorly water soluble.
Danish: Enzalutamid opløses ikke nemt i vand.
English: Hypersensitivity reactions manifested by symptoms including, but not limited to, rash, or face, tongue, lip, or pharyngeal oedema, have been observed with enzalutamide (see section 4.8).
Danish: Der er observeret overfølsomhedsreaktioner med enzalutamid, som viser sig ved symptomer, der omfatter, men ikke er begrænset til, udslæt eller ansigts-, tunge-, læbe- eller faryngealt ødem (se pkt.
English: Xtandi - 80 mg film-coated tablets Each film-coated tablet contains 80 mg of enzalutamide.
Danish: Xtandi - 80 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder indeholder 80 mg enzalutamid.