natgillin/translations-raw huggingface dataset:
Tid til PSA-progression baseret på PCWG2-kriterier: Mediantiden til PSA-progression var 33,2 måneder for patienter, der fik ZYTIGA, og 7,4 måneder for patienter, der fik placebo (HR = 0,299; 95 % KI: [0,255, 0,352], p < 0,0001). 
Time to PSA progression based on PCWG2 criteria: The median time to PSA progression was 33.2 months for patients receiving ZYTIGA and 7.4 months for patients receiving placebo (HR = 0.299; 95% CI: [0.255, 0.352], p <0.0001).
KARTON 500 mg 
CARTON 500 mg
Patienter på natrium- eller saltfattig diæt skal tage hensyn hertil. 
To be taken into consideration by patients on a controlled sodium diet.
Patienter med atrieflimren eller anden hjertearytmi, der kræver medicinsk behandling, blev ekskluderet fra studie 3011 og 302. 
In studies 3011 and 302, patients with atrial fibrillation, or other cardiac arrhythmia requiring medical therapy were excluded.
Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion (se pkt. 
No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Tiden indtil anvendelse af opiat mod cancersmerter: Mediantiden indtil brug af opiat mod prostatacancersmerter på tidspunktet for den endelige analyse var 33,4 måneder for patienter, der fik ZYTIGA, og 23,4 måneder for patienter, der fik placebo (HR =0,721; 95 % KI [0,614; 0,846], p < 0,0001). 
Time to opiate use for cancer pain: The median time to opiate use for prostate cancer pain at the time of final analysis was 33.4 months for patients receiving ZYTIGA and was 23.4 months for patients receiving placebo (HR = 0.721; 95% CI: [0.614; 0.846], p < 0.0001).
- Brug kondom for at beskytte fostret, hvis du har sex med en gravid kvinde. 
- If you are having sex with a pregnant woman, use a condom to protect the unborn child.
• Behandling af nydiagnosticeret, metastaserende hormonfølsom prostatacancer (mHSPC) med høj risiko hos voksne mænd i kombination med androgen deprivationsbehandling (ADT) (se pkt. 
(mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section
Knogler, led, muskler og bindevæv ikke almindelige: myopati, rabdomyolyse 
Musculoskeletal and connective tissue disorders uncommon: myopathy, rhabdomyolysis
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose (silicificeret), croscarmellosenatrium, hypromellose 2910 (15 mPa.S), lactosemonohydrat, magnesiumstearat, kolloid vandfri silica, natriumlaurilsulfat; (se ”ZYTIGA indeholder lactose og natrium” under punkt 2). 
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone (K29/K32), colloidal anhydrous silica, and sodium laurilsulfate (see section 2, “ZYTIGA contains lactose and sodium”).
Tid til efterfølgende behandling: På tidspunktet for interimanalysen var mediantiden til efterfølgende behandling ikke nået hos patienter, der fik ZYTIGA, og den var 21,6 måneder for patienter, der fik placebo (HR = 0,415; 95 % KI: [0,346, 0,497], p < 0,0001). 
Time to subsequent therapy: The median time to subsequent therapy at the time of interim analysis was not reached for patients receiving ZYTIGA and was 21.6 months for patients receiving placebo (HR = 0.415; 95% CI: [0.346, 0.497], p <0.0001).
I den aktive arm blev ZYTIGA administreret i en dosis på 1000 mg dagligt i kombination med lavdosis prednison 5 mg en gang dagligt udover ADT (LHRH-agonist eller orkiektomi), som var standardbehandlingen. 
In the active arm, ZYTIGA was administered at a dose of 1000 mg daily in combination with low dose prednisone 5 mg once daily in addition to ADT
70 % havde radiografisk dokumenteret sygdomsprogression med eller uden PSA-progression. 
Eleven percent of patients enrolled had an ECOG performance score of 2; 70% had radiographic evidence of disease progression with or without PSA progression; 70% had received one prior cytotoxic chemotherapy and 30% received two.
* p-værdi er beregnet fra en log-rank test stratificeret ved baseline-ECOG-score (0 eller 1) ** Hazard ratio < 1 indikere en fordel for ZYTIGA 
* p-value is derived from a log-rank test stratified by baseline ECOG score (0 or 1) ** Hazard ratio < 1 favours ZYTIGA
Tid til smerteprogression: Mediantiden til smerteprogression blev ikke nået for patienter, der fik ZYTIGA, og var 16,6 måneder for patienter, der fik placebo (HR = 0,695; 95 % KI: [0,583, 0,829], p < 0,0001). 
Time to pain progression: The median time to pain progression was not reached for patients receiving ZYTIGA and was 16.6 months for patients receiving placebo (HR = 0.695; 95% CI: [0.583, 0.829], p <0.0001).
Median tid til PSA-progression var 10,2 måneder for patienter, der blev behandlet med ZYTIGA, og 6,6 måneder for patienter, der fik placebo (HR=0,580; 95 % KI: [0,462; 0,728]; p < 0,0001). 
The median time to PSA progression was 10.2 months for patients treated with ZYTIGA and 6.6 months for patients treated with placebo (HR = 0.580; 95% CI: [0.462; 0.728], p < 0.0001).
Almindelige (kan berøre op til 1 ud af 10 behandlede): 
Common (may affect up to 1 in 10 people):
Tid til påbegyndelse af kemoterapi: Mediantiden til påbegyndelse af kemoterapi blev ikke nået for patienter, der fik ZYTIGA, og var 38,9 måneder for patienter, der fik placebo (HR = 0,443; 95 % KI: [0,349, 0,561], p < 0,0001). 
Time to initiation of chemotherapy: The median time to initiation of chemotherapy was not reached for patients receiving ZYTIGA and was 38.9 months for patients receiving placebo (HR = 0.443; 95% CI: [0.349, 0.561], p < 0.0001).
Tid til PSA-progression baseret på PCWG-kriterier: Mediantiden til PSA-progression var 11,1 måneder for patienter, der fik ZYTIGA, og 5,6 måneder for patienter, der fik placebo (HR=0,488; 95 % KI: [0,420; 0,568], p < 0,0001). 
Time to PSA progression based on PCWG2 criteria: The median time to PSA progression was 11.1 months for patients receiving ZYTIGA and 5.6 months for patients receiving placebo (HR = 0.488; 95% CI: [0.420; 0.568], p < 0.0001).
Tiden indtil påbegyndelse af cytotoksisk kemoterapi: Mediantiden indtil påbegyndelse af cytotoksisk kemoterapi var 25,2 måneder for patienter, der fik ZYTIGA, og 16,8 måneder for patienter, der fik placebo (HR=0,580; 95 % KI: [0,487; 0,69], p < 0,0001). 
Time to initiation of cytotoxic chemotherapy: The median time to initiation of cytotoxic chemotherapy was 25.2 months for patients receiving ZYTIGA and 16.8 months for patients receiving placebo (HR = 0.580; 95% CI: [0.487; 0.691], p < 0.0001).
NE= Ikke estimeret * p-værdi er beregnet fra en log-rank test stratificeret ved baseline-ECOG-score (0 eller 1) ** Hazard ratio < 1 indikere en fordel for ZYTIGA 
NE = Not estimated * p-value is derived from a log-rank test stratified by baseline ECOG score (0 or 1) ** Hazard ratio < 1 favours ZYTIGA
- Svært nedsat leverfunktion [Child--Pugh-klasse C (se pkt. 
- Severe hepatic impairment [Child-Pugh Class C (see sections 4.2, 4.4 and 5.2)].
Abirateronacetat bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt. 
abiraterone acetate should not be used in patients with severe hepatic impairment (see sections 4.2, 4.3 and 4.4).
Det skal du vide, før du begynder at tage ZYTIGA Sådan skal du tage ZYTIGA Bivirkninger 
What ZYTIGA is and what it is used for What you need to know before you take ZYTIGA How to take ZYTIGA
Ikke almindelige (kan berøre op til 1 ud af 100 patienter): 
Uncommon (may affect up to 1 in 100 people):
Tabel 3: Samlet overlevelse, stratificeret analyse; intent-to-treat-population (studie PCR3011) 
Overall Survival, Stratified Analysis; Intent-to-treat Population (Study PCR3011) AA-P
Knoglerelaterede hændelser 
Skeletal-related events
Tabel 4: Studie 302: Radiografisk progressionsfri overlevelse hos patienter behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi ZYTIGA (N=546) 
Table 4: Study 302: Radiographic progression-free survival of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy ZYTIGA (N = 546)
Hver tablet indeholder 250 mg abirateronacetat. 
Each tablet contains 250 mg of abiraterone acetate.
Note: += Censureret observation, NE= ikke evaluerbar. 
b 0.466 (0.394, 0.550) Note: += censored observation, NE=not estimable.
I fertilitetsstudier med både han- og hunrotter reducerede abirateronacetat fertiliteten. 
In fertility studies in both male and female rats, abiraterone acetate reduced fertility, which was completely reversible in 4 to 16 weeks after abiraterone acetate was stopped.
Tabletterne skal sluges hele med vand. 
Swallow the tablets whole with water.
ZYTIGA bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt. 
ZYTIGA should not be used in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Hver filmovertrukken tablet indeholder 500 mg abirateronacetat. 
Each film-coated tablet contains 500 mg of abiraterone acetate.
Figur 4: Kaplan Meier-kurver af radiografiske progressionsfri overlevelse hos patienter behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi (ved den anden interimanalyse af OS-investigators vurdering) 
Figure 4: Kaplan Meier curves of radiographic progression-free survival in patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy (At second interim analysis of OS-Investigator Review)
Figur 5: Kaplan Meier overlevelseskurver for patienter behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi, endelig analyse 
Figure 5: Kaplan Meier survival curves of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy, final analysis
Tabel 5: Studie 302: Radiografisk progressionsfri overlevelse hos patienter behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi (ved den anden interimanalyse af OSinvestigators vurdering) 
Table 5: Study 302: Radiographic progression-free survival of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy (At second interim analysis of OS-Investigator Review)
p-værdi* Hazard ratio** (95 % KI) Endelig overlevelsesanalyse Dødsfald (%) Median samlet overlevelse (i måneder) (95 % KI) p-værdi* Hazard ratio** (95 % KI) 
Final survival analysis Deaths Median overall survival in months (95% CI) p-value* Hazard ratio** (95% CI)
Figur 3: Kaplan Meier kurver af radiografisk progressionsfri overlevelse hos patienter, der er behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analoger eller tidligere orkiektomi 
Figure 3: Kaplan Meier curves of radiographic progression-free survival in patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy
Tabel 7: Samlet overlevelse hos patienter i behandling med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog- eller tidligere orkiektomi 
Table 7: Overall survival of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy
Tabel 6: Studie 302: Samlet overlevelse hos patienter behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi. 
Table 6: Study 302: Overall survival of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy
- Kontakt straks lægen, hvis du har glemt at tage ZYTIGA, prednison eller prednisolon i mere end en dag. 
- If you forget to take ZYTIGA or prednisone or prednisolone for more than one day, talk to your doctor without delay.
ZYTIGA må derfor ikke indtages i forbindelse med et måltid, men indtages mindst to timer efter fødeindtagelse, og føde må ikke indtages i mindst én time efter indtagelse af ZYTIGA. 
It should be taken at least two hours after eating and no food should be eaten for at least one hour after taking ZYTIGA.
En filmovertrukken tablet indeholder 500 mg abirateronacetat. 
Each film-coated tablet contains 500 mg abiraterone acetate.
Tiden til smerteprogression ved den 25. percentil var 7,4 måneder i ZYTIGA-gruppen versus 4,7 måneder i placebo-gruppen. 
versus 4.7 months in the placebo group.
- Opbevar lægemidlet utilgængeligt for børn. 
- Keep this medicine out of the sight and reach of children.
Figur 6: Kaplan Meier-overlevelseskurver for patienter, der fik enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi 
Figure 6: Kaplan Meier survival curves of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy
Nyrer og urinveje almindelige: hæmaturi 
Renal and urinary disorders common: haematuria
Magnesiumstearat 
Tablet core
HR=hazard ratio; NE=ikke evaluerbar. 
Range p value Hazard ratio (95% CI) Note:+= censored observation, NE = not estimable.
Gravide kvinder eller kvinder, som kan være gravide, bør ikke håndtere det uden at anvende sikkerhedsudstyr, f.eks. handsker. 
Based on its mechanism of action, this medicinal product may harm a developing foetus; therefore, women who are pregnant or may be pregnant should not handle it without protection, e.g., gloves.
Efter oral administration af 1.000 mg 
Following oral administration of
Forsøgspersoner med risiko 
Patients with elevations of ALT or
I tilfælde af et klinisk signifikant fald i hjertefunktionen bør det overvejes at seponere ZYTIGA (se pkt. 
Assess cardiac function as clinically indicated, institute appropriate management and consider discontinuation of this treatment if there is a clinically significant decrease in cardiac function (see section 4.2).
4.8) som følge af de forhøjede mineralokortikoidniveauer forårsaget af CYP17-hæmning (se pkt. 
Hypertension, hypokalaemia, fluid retention and cardiac failure due to mineralocorticoid excess ZYTIGA may cause hypertension, hypokalaemia and fluid retention (see section 4.8) as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition (see section 5.1).
Hos patienter med let nedsat leverfunktion er dosisjustering ikke nødvendig. 
No dose adjustment is necessary for patients with pre-existing mild hepatic impairment.
Frågor och svar 
Questions and answers
Sida 2/2 
Page 2/2
Vad har företaget lämnat in som stöd för sin ansökan? 
What did the company present to support its application?
Ungefär en femtedel av patienterna var i åldern 13 och 14 år. 
Around a fifth of the patients were aged 13 and 14 years.
Vilka är följderna för patienter i kliniska prövningar? 
What are the consequences for patients in clinical trials?
Mer information om Abilify finns på EMA:s webbplats. 
More information about Abilify is available on EMA's website.
Om du deltar i en klinisk prövning och vill få mer information om din behandling kan du kontakta den läkare som ger dig läkemedlet. 
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Dess exakta verkningsmekanism är okänd, men det anses verka via flera olika receptorer i hjärnan, där det partiellt härmar eller blockerar verkan av neurotransmittorerna dopamin och 5-hydroxytryptamin (även kallat serotonin). 
Its exact mechanism of action is unknown, but it is believed to work through several different receptors in the brain, where it partially mimics or blocks the action of the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
I studien undersöktes hur effektivt Abilify förhindrade ett återfall av deras symtom. 
The study investigated how effectively Abilify prevented a relapse of their symptoms.
Även om återfallsfrekvensen med Abilify hos 13- och 14-åringar var likartad med frekvensen hos äldre barn (21 procent respektive 19 procent), var antalet patienter i huvudstudien för litet för att man skulle kunna dra några definitiva slutsatser i den yngre gruppen. 
Although the relapse rate with Abilify in 13 and 14 year olds was similar to the rate in older children (21% and 19% respectively), the number of patients in the main study was too small to draw firm conclusions in the younger group.
CHMP ansåg inte att de data som lämnats in som stöd för ansökan var tillräckliga för att rekommendera en utvidgning av läkemedlets användning. 
The CHMP did not consider the data supporting the application sufficient to recommend extending the medicine's use.
Eftersom dessa neurotransmittorer medverkar vid schizofreni och bipolär sjukdom kan aripiprazol bidra till att normalisera deras verkan på hjärnan, vilket minskar de psykotiska eller maniska symtomen och hindrar dem från att återkomma. 
Because these neurotransmitters are involved in schizophrenia and bipolar disorder, aripiprazole can help to normalise their activity in the brain, reducing psychotic or manic symptoms and preventing them from returning.
Vad händer med Abilify vid behandling av andra sjukdomar? 
What is happening with Abilify for the treatment of other diseases?
För schizofreni är det för närvarande godkänt endast för patienter som är 15 år och äldre. 
For schizophrenia it is currently approved only for patients aged 15 years and over.
Kommittén ansåg emellertid att dessa data kunde vara viktiga för hälso- och sjukvårdspersonal och rekommenderade att de skulle inkluderas i produktinformationen för Abilify. 
However, the Committee considered that the data could be important for healthcare professionals and recommended their inclusion in Abilify's product information.
Vad har CHMP kommit fram till? 
What was the conclusion of the CHMP?
Den aktiva substansen i Abilify, aripiprazol, är ett antipsykotiskt läkemedel. 
The active substance in Abilify, aripiprazole, is an antipsychotic medicine.
Vad är Abilify? 
What is Abilify?
Resultatet av denna ansökan får inga följder för patienter som för närvarande deltar i eller som kommer att delta i kliniska prövningar med Abilify. 
There are no consequences of the outcome of this application on patients currently in or who may be joining clinical trials with Abilify.
CHMP konstaterade emellertid att schizofreni är sällsynt hos yngre patienter och att införandet av dessa data i produktinformationen för Abilify skulle kunna hjälpa hälso- och sjukvårdspersonalen som behandlar dem. 
However, the CHMP noted that schizophrenia is rare in younger patients and that including the data in Abilify's product information could help the healthcare professionals who manage them.
Den 15 september 2016 avslutade kommittén för humanläkemedel (CHMP) granskningen av en ansökan om att utvidga användningen av Abilify vid schizofreni till ungdomar i åldern 13 och 14 år. 
On 15 September 2016, the Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of Abilify in schizophrenia to adolescents aged 13 and 14 years.
Vad skulle Abilify användas för? 
What was Abilify expected to be used for?
Abilify är ett läkemedel för behandling av schizofreni och bipolär sjukdom. 
Abilify is a medicine for treating schizophrenia and bipolar disorder.
Därför kom CHMP fram till att Abilify inte kunde godkännas för schizofreni hos 13- och 14-åringar på basis av dessa data. 
The CHMP therefore concluded that Abilify could not be approved for schizophrenia in 13 and 14 year olds on the basis of these data.
Det blir inga följder för användningen av Abilify vid bipolär sjukdom eller dess för närvarande godkända användning för patienter med schizofreni som är 15 år och äldre. 
There are no consequences on the use of Abilify in bipolar disorder or its currently approved use in patients with schizophrenia aged 15 years and over.
Det innehåller den aktiva substansen aripiprazol. 
Abilify contains the active substance aripiprazole.
Ansökan om att utvidga användningen av Abilify vid schizofreni till 13- och 14-åringar 
Application to extend use of Abilify in schizophrenia to 13 and 14 year olds
Företaget som marknadsför Abilify ansökte om att det skulle användas för att behandla schizofreni hos patienter som är 13 år och äldre. 
The company that markets Abilify applied for it to be used to treat schizophrenia in patients aged 13 years and over.
Företaget presenterade data från en huvudstudie som omfattade 146 ungdomar med stabila symtom på schizofreni. 
The company presented data from a main study in which 146 adolescents with schizophrenia whose symptoms were stable received either Abilify or placebo (a dummy treatment) for one year.
Hur verkar Abilify? 
How does Abilify work?
Den anbefalede dosis afhænger af patientens legemsvægt og gives én gang om ugen de første fire uger og derefter hver anden uge. 
The recommended dose depends on the patient's body weight and is given once a week for the first 4 weeks and then every 2 weeks.
Virkningen er klinisk relevant i betragtning af, at patienterne har begrænsede behandlingsmuligheder. 
Effects are clinically relevant considering that patients have limited treatment options.
Som for alle lægemidler bliver data vedrørende brug af Poteligeo løbende overvåget. 
As for all medicines, data on the use of Poteligeo are continuously monitored.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Poteligeo? 
What measures are being taken to ensure the safe and effective use of Poteligeo?
For mere information om brug af Poteligeo, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about using Poteligeo, see the package leaflet or contact your doctor or pharmacist.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Poteligeo opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency therefore decided that Poteligeo's benefits are greater than its risks and it can be authorised for use in the EU.
Andre oplysninger om Poteligeo 
Other information about Poteligeo
Lægemidlet gives som infusion (drop) i en blodåre over mindst 1 time. 
The medicine is given as an infusion (drip) into a vein lasting at least 1 hour.
Yderligere information om Poteligeo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Further information on Poteligeo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Bivirkninger rapporteret for Poteligeo vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Poteligeo are carefully evaluated and any necessary action taken to protect patients.
Patienterne bør overvåges for visse infusionsrelaterede bivirkninger under og efter infusionen. 
Patients should be monitored during and after the infusion for certain side effects related to the infusion.
For at minimere risikoen kan patienterne få andre lægemidler, som f.eks. et feberstillende lægemiddel og et antihistamin (mod allergiske reaktioner), før eller under behandlingen med Poteligeo. 
To reduce this risk, patients may be given other medicines such as an antipyretic (medicine that reduces fever) and an antihistamine (for treating allergic reactions) before or during treatment with Poteligeo.
Yderligere oplysninger om lægemidler til sjældne sygdomme findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation 
Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
De hyppigst indberettede alvorlige bivirkninger er lungebetændelse, feber, infusionsrelaterede reaktioner og cellulitis (betændelse af det dybereliggende væv i huden). 
The most commonly reported serious reactions are pneumonia (infection of the lungs), fever, infusion-related reactions and cellulitis (inflammation of the deep skin tissue).
En oversigt over Poteligeo, og hvorfor det er godkendt i EU 
An overview of Poteligeo and why it is authorised in the EU