FrancophonIA/ELRC3.0 huggingface dataset:
English: Range p value Hazard ratio (95% CI)
Slovenian: Vrednost p Razmerje tveganja (95% IZ)
English: The median radiographic progression-free survival was 5.6 months for patients treated with ZYTIGA and 3.6 months for patients who received placebo (HR = 0.673; 95% CI: [0.585; 0.776], p < 0.0001).
Slovenian: Mediani čas preživetja do radiološko potrjenega napredovanja bolezni je pri bolnikih, ki so prejemali zdravilo ZYTIGA, znašal 5,6 meseca v primerjavi s 3,6 meseca pri bolnikih, ki so prejemali placebo (razmerje tveganja = 0,673; 95% IZ: [0,585; 0,776], p < 0,0001).
English: C-abiraterone acetate 1,000 mg, approximately 88% of the radioactive dose is recovered in faeces and approximately 5% in urine.
Slovenian: C-abirateronacetata je v blatu mogoče prestreči približno 88%
English: - This medicine also contains approximately 27 mg of sodium in a two tablet daily dose.
Slovenian: - To zdravilo vsebuje tudi približno 27 mg natrija na odmerek na dan (v dveh tabletah), kar morajo upoštevati bolniki na dieti z nadzorovanim vnosom natrija.
English: A condom is required if the patient is engaged in sexual activity with a pregnant woman.
Slovenian: Če ima bolnik spolne odnose z nosečo žensko, mora uporabljati kondom.
English: 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).
Slovenian: Čas do zviševanja koncentracij PSA na podlagi kriterijev PCWG2: Mediani čas do zviševanja koncen je bil pri bolnikih, ki so prejemali zdravilo ZYTIGA 33,2 meseca, pri bolnikih, ki so prejemali placebo 7,4 meseca (razmerje tveganja = 0,299; 95% IZ: [0,255; 0,352], p = 0,0001).
English: Decreased bone density may occur in men with metastatic advanced prostate cancer.
Slovenian: Pri bolnikih z napredovalim metastatskim rakom prostate lahko pride do zmanjšanja kostne gostote.
English: This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood.
Slovenian: Med jemanjem tega zdravila vam bo zdravnik predpisal še eno zdravilo prednizon ali prednizolon, in sicer zato, da bi zmanjšal možnost za pojav visokega krvnega tlaka, zadrževanja prevelikih količin vode v telesu (zastajanja tekočin) ali znižanja koncentracije kalija v vašem telesu.
English: Each film-coated tablet contains 500 mg abiraterone acetate.
Slovenian: Ena filmsko obložena tableta vsebuje 500 mg abirateronacetata.
English: The Eastern Cooperative Oncology Group (ECOG) performance status was 0 for 76% of patients, and 1 for 24% of patients in both arms.
Slovenian: Šestinsedemdeset odstotkov vključenih bolnikov v obeh krakih je na lestvici ocenjevanja stanja zmogljivosti ECOG (Eastern Cooperative Oncology Group) doseglo oceno 0 in 24% oceno 1.
English: 120 tablets.
Slovenian: Ena plastenka vsebuje 120 tablet.
English: Skin and subcutaneous tissue disorders common: rash
Slovenian: Bolezni kože in podkožja pogosti: izpuščaj
English: A statistically significant improvement in OS in favor of AA-P plus ADT was observed with a 38% reduction in the risk of death compared to Placebo plus ADT (HR=0.621; 95% CI: 0.509, 0.756; p<0.0001), crossing the pre-specified boundary for OS at Interim Analysis 1 of 0.010 (see Table 3 and Figure 2).
Slovenian: Opažali statistično značilno izboljšanje v OS in 38% zmanjšanje tveganja za smrt v prid skupine, ki je prejemala AA-P skupaj z ADT kot v skupini, ki je prejemala placebo in ADT (HR=0,621; 95% IZ: 0,509; 0,756; p<0,0001); presežena je bila vnaprej določena meja za celokupno preživetje 0,010 iz vmesne analize 1 (glejte Preglednico 3 in Sliko 2).
English: Each film-coated tablet contains 500 mg of abiraterone acetate.
Slovenian: Ena filmsko obložena tablet vsebuje 500 mg abirateronacetata.
English: (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section
Slovenian: • za zdravljenje na novo diagnosticiranega hormonsko občutljivega metastatskega raka prostate z visokim tveganjem (mHSPC - Metastatic Hormone Sensitive Prostate Cancer) pri odraslih bolnikih v kombinaciji z zdravljenjem z deprivacijo androgenov (ADT - Androgen Deprivation Therapy) (glejte poglavje 5.1).
English: Each tablet contains 250 mg abiraterone acetate.
Slovenian: Ena tableta vsebuje 250 mg abirateronacetata.
English: - This medicine also contains approximately 27 mg of sodium in a four tablet daily dose.
Slovenian: - To zdravilo vsebuje tudi približno 27 mg natrija na odmerek na dan (v štirih tabletah), kar morajo upoštevati bolniki na dieti z nadzorovanim vnosom natrija.
English: The tablets should be taken at least two hours after eating and no food should be eaten for at least one hour after taking the tablets.
Slovenian: Tablete je treba jemati najmanj dve uri po obroku.
English: 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).
Slovenian: Čas do naslednjega zdravljenja: Mediani čas do naslednjega zdravljenja v času vmesne analize pri bolnikih, ki so prejemali zdravilo ZYTIGA ni bil dosežen, pri bolnikih, ki so prejemali placebo pa je bil 21,6 meseca (razmerje tveganja = 0,415; 95% IZ: [0,346; 0,497], p = 0,0001).
English: How to store ZYTIGA
Slovenian: Shranjevanje zdravila ZYTIGA
English: Range p value Hazard ratio (95% CI) Note:+= censored observation, NE = not estimable.
Slovenian: Opomba: += krnjeno opažanje, NE=ocena ni mogoča (not estimable).
English: Hazard ratio (95% CI) Updated Survival Analysis Deaths (%) Median survival (months) (95% CI) Hazard ratio (95% CI)
Slovenian: Razmerje tveganja (95% IZ) Dodatna analiza preživetja Število smrti (%) Mediano preživetje (meseci) (95% IZ)
English: 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).
Slovenian: Čas do napredovanja bolečine: Mediani čas do napredovanja bolečine pri bolnikih, ki so prejemali zdravilo ZYTIGA ni bil dosežen, pri bolnikih, ki so prejamali placebo pa je bil 16,6 meseca (razmerje tveganja = 0,695; 95% IZ: [0,583; 0,829], p = 0,0001).
English: 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).
Slovenian: Čas do uvedbe kemoterapije: Mediani čas do uvedbe kemoterapije ni bil dosežen pri bolnikih, ki so prejemali zdravilo ZYTIGA, pri bolnikih, ki so prejemali placebo pa je bil 38,9 meseca (razmerje tveganja = 0,443; 95% IZ: [0,349; 0,561], p = 0,0001).
English: Bone density
Slovenian: Kostna gostota
English: CTCAE (version 4.0) Grade 4 urinary tract infection, alanine aminotransferase increased and/or aspartate aminotransferase increased, hypokalemia, cardiac failure, atrial fibrillation, and fractures occurred in < 1% of patients.
Slovenian: Do okužbe sečil, zvišane koncentracije alanin-aminotransferaze in/ali aspartat-aminotransferaze, hipokaliemije, srčnega popuščanja, atrijske fibrilacije in zlomov 4. stopnje po CTCAE (verzija 4.0) je prišlo pri manj kot 1% bolnikov.
English: ZYTIGA is for oral use.
Slovenian: Zdravilo ZYTIGA se jemlje peroralno.
English: - If you get any side effects talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Treatment with ZYTIGA decreases serum testosterone to undetectable levels (using commercial assays) when given with LHRH analogues (or orchiectomy).
Slovenian: Zdravljenje z zdravilom ZYTIGA ob sočasni uporabi analogov gonadorelina (ali skupaj z orhidektomijo) zniža koncentracijo testosterona v serumu na (s komercialnimi testi) nemerljive vrednosti.
English: Hepatotoxicity with elevated ALT, AST and total bilirubin has been reported in patients treated with abiraterone acetate.
Slovenian: Pri bolnikih, ki so prejemali abirateronacetat, so poročali o hepatotoksičnosti z zvečanimi koncentracijami ALT, AST in celokupnega bilirubina.
English: 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).
Slovenian: Mediani čas do zviševanja koncentracije PSA je bil pri bolnikih, ki so prejemali zdravilo ZYTIGA, 10,2 meseca v primerjavi s 6,6 meseca pri bolnikih, ki so prejemali placebo (razmerje tveganja = 0,580; 95% IZ: [0,462; 0,728], p < 0,0001).
English: Censored
Slovenian: Odmerjanje
English: Overall Survival, Stratified Analysis; Intent-to-treat Population (Study PCR3011) AA-P
Slovenian: Preglednica 3: Celokupno preživetje, stratificirana analiza; populacija z namenom zdravljenja (študija PCR3011)
English: The Phase 3 studies conducted with ZYTIGA excluded patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class (NYHA) III or IV heart failure (study 301) or Class II to IV heart failure (studies 3011 and 302) or cardiac ejection fraction measurement of < 50%.
Slovenian: Bolniki z nenadzorovano hipertenzijo, klinično pomembno srčno boleznijo, kot so miokardni infarkt ali arterijski trombotični dogodki v zadnjih 6 mesecih, s hudo nestabilno angino pektoris, srčnim popuščanjem stopnje III ali IV (študija 301) ali srčnim popuščanjem razreda II do IV (študiji 3011 in 302) po klasifikaciji Newyorškega združenja za srce (NYHA - New York Heart Association) ali vrednostjo iztisnega deleža srca < 50%, niso bili vključeni v študije faze 3 z zdravilom ZYTIGA.
English: QT prolongation has been observed in patients experiencing hypokalaemia in association with ZYTIGA treatment.
Slovenian: Pri bolnikih s hipokaliemijo, povezano z zdravilom ZYTIGA, so poročali o podaljšanju intervala QT.
English: No dose adjustment is necessary for patients with pre-existing mild hepatic impairment.
Slovenian: Bolnikom z obstoječo blago okvaro jeter ni treba prilagajati odmerkov.
English: Not known (frequency cannot be estimated from the available data):
Slovenian: NE = ni ocenjeno (not estimated).
English: In the active treatment arm, ZYTIGA was administered at a dose of 1,000 mg daily in combination with low dose prednisone or prednisolone 5 mg twice daily.
Slovenian: Bolniki v skupini z aktivnim zdravljenjem so prejemali zdravilo ZYTIGA v odmerku 1.000 mg na dan v kombinaciji z nizkimi odmerki prednizona ali prednizolona 5 mg dvakrat na dan. Bolniki v kontrolni skupini so prejemali placebo in nizke odmerke prednizona ali prednizolona 5 mg dvakrat na dan.
English: 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)
Slovenian: Preglednica 4: Študija 302: Radiološko potrjeno preživetje brez napredovanja bolezni bolnikov, ki so prejemali bodisi zdravilo ZYTIGA bodisi placebo v kombinaciji s prednizonom ali prednizolonom ter z analogi LHRH oziroma so jih predhodno zdravili z orhidektomijo ZYTIGA (n=546)
English: ZYTIGA contains a medicine called abiraterone acetate.
Slovenian: Zdravilo ZYTIGA vsebuje učinkovino abirateronacetat.
English: Radiographic Progression-Free Survival - Stratified Analysis; Intent-to-treat Population (Study PCR3011)
Slovenian: Preglednica 2: Radiološko potrjeno preživetje brez napredovanja bolezni- -stratificirana analiza; populacija bolnikov z namenom zdravljenja Intent-to-treat Population (študija PCR3011)
English: Primary Survival Analysis Deaths (%) Median survival (months) (95% CI) p-value
Slovenian: Primarna analiza preživetja Število smrti (%) Mediano preživetje (meseci) (95% IZ)
English: BOTTLE LABEL 250 mg
Slovenian: NALEPKA NA PLASTENKI 250 mg
English: Systemic exposure to abiraterone after a single oral 1,000 mg dose increased by approximately 11% and 260% in subjects with mild and moderate pre-existing hepatic impairment,
Slovenian: Pri osebah s prisotno blago ali zmerno okvaro jeter je bila po enkratnem peroralnem odmerku 1.000 mg sistemska izpostavljenost abirateronu večja za 11% oziroma za 260%.
English: 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
Slovenian: NE=ni ocenjeno (Not Estimated) * Vrednost p je izračunana na osnovi log-rank testa, stratificiranega glede na začetno vrednost po lestvici ECOG (0 ali
English: Bone loss may occur in men treated for prostate cancer.
Slovenian: Pri bolnikih, ki se zdravijo za rakom prostate, lahko pride do zmanjšanja kostne gostote.
English: Study 301 (patients who had received prior chemotherapy) Study 301 enrolled patients who had received prior docetaxel.
Slovenian: V študijo 301 so bili vključeni bolniki, ki so predhodno prejemali docetaksel.
English: BLISTER 500 mg
Slovenian: PRETISNI OMOT 500 mg
English: Take the prednisone or prednisolone exactly as your doctor has told you.
Slovenian: Pri jemanju prednizona ali prednizolona natančno upoštevajte zdravnikova navodila.
English: 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
Slovenian: Kaplan Meierjevi krivulji preživetja bolnikov ki so prejemali bodisi zdravilo ZYTIGA bodisi placebo v kombinaciji s prednizonom ali prednizolonom ter z analogi LHRH oziroma so jih predhodno zdravili z orhidektomijo; končna analiza
English: th percentile was 7.4 months in the ZYTIGA group,
Slovenian: Vrednost 25. percentile časa do napredovanja bolečine je bila v skupini z zdravilom ZYTIGA 7,4 meseca v primerjavi s 4,7 meseca v skupini s placebom.
English: 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)
Slovenian: Preglednica 5: Študija 302: Radiološko potrjeno preživetje brez napredovanja bolezni bolnikov, ki so prejemali bodisi zdravilo ZYTIGA bodisi placebo v kombinaciji s prednizonom ali prednizolonom ter z analogi LHRH oziroma so jih predhodno zdravili z orhidektomijo (druga vmesna analiza celokupnega preživetja-ocena raziskovalca) ZYTIGA (n=546)
English: 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)
Slovenian: Kaplan-Meierjevi krivulji radiološko potrjenega preživetja brez napredovanja bolezni bolnikov, ki so prejemali bodisi zdravilo ZYTIGA bodisi placebo v kombinaciji s prednizonom ali prednizolonom ter z analogi LHRH oziroma so jih predhodno zdravili z orhidektomijo (druga vmesna analiza celokupnega preživetja-ocena raziskovalca)
English: CARTON 250 mg
Slovenian: ŠKATLA 250 mg
English: 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
Slovenian: Preglednica 6: Študija 302: Celokupno preživetje bolnikov, ki so prejemali bodisi zdravilo ZYTIGA bodisi placebo v kombinaciji s prednizonom ali prednizolonom ter analogi LHRH oziroma so jih predhodno zdravili z orhidektomijo ZYTIGA (n=546)
English: - The amount of prednisone or prednisolone you take may need to change if you have a medical emergency.
Slovenian: - V primeru nujnega medicinskega stanja boste morda morali jemati več prednizona ali prednizolona.
English: Always take this medicine exactly as your doctor has told you.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte zdravnikova navodila.
English: 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).
Slovenian: Poleg opaženega izboljšanja celokupnega preživetja in rPFS so vse primerjave pri sekundarnih ciljih opazovanja govorile v prid uporabe zdravila ZYTIGA v primerjavi s placebom Čas do zviševanja koncentracij PSA na podlagi kriterijev PCWG2: mediani čas do zviševanja koncentracij PSA je bil pri bolnikih, ki so prejemali zdravilo ZYTIGA, 11,1 meseca in pri bolnikih, ki so prejemali placebo, 5,6 meseca (razmerje tveganja=0,488; 95% IZ: [0,420; 0,568], p < 0,0001).
English: 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
Slovenian: V aktivni skupini so bolniki ob standardnem zdravljenju z ADT (agonisti LHRH ali orhidektomija) prejemali 1.000 mg zdravila ZYTIGA skupaj z majhnim, 5 mg odmerkom prednizona na dan. Bolniki v kontrolni skupini so prejemali ADT in placebo tako za zdravilo ZYTIGA kot za prednizon.
English: CARTON 500 mg
Slovenian: ŠKATLA 500 mg
English: Table 7: Overall survival of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy
Slovenian: Preglednica 7: Celokupno preživetje bolnikov, ki so prejemali bodisi zdravilo ZYTIGA bodisi placebo v kombinaciji s prednizonom ali prednizolonom ter analogi LHRH oziroma so jih predhodno zdravili z orhidektomijo ZYTIGA (n=797)
English: 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
Slovenian: Kaplan-Meierjevi krivulji radiološko potrjenega preživetja brez napredovanja bolezni bolnikov, ki so prejemali bodisi zdravilo ZYTIGA bodisi placebo v kombinaciji s prednizonom ali prednizolonom ter z analogi LHRH oziroma so jih predhodno zdravili z orhidektomijo
English: 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).
Slovenian: Zdravilo ZYTIGA lahko povzroča hipertenzijo, hipokaliemijo in zastajanje tekočin (glejte poglavje 4.8).
English: For patients being re-treated, serum transaminases should be monitored at a minimum of every two weeks for three months and monthly thereafter.
Slovenian: Pri teh bolnikih je treba najmanj vsaka dva tedna v naslednjih treh mesecih, nato pa mesečno spremljati koncentracije serumskih aminotransferaz.
English: 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
Slovenian: Kaplan-Meierjevi krivulji preživetja bolnikov, ki so prejemali bodisi zdravilo ZYTIGA bodisi placebo v kombinaciji s prednizonom ali prednizolonom ter agonisti LHRH oziroma so jih predhodno zdravili z orhidektomijo
English: No dose adjustment is necessary for patients with pre-existing mild hepatic impairment, Child-Pugh Class A.
Slovenian: Okvara jeter Bolnikom z blago okvaro jeter Child-Pugh razreda A ni treba prilagajati odmerkov.
English: Tablet core
Slovenian: PODATKI NA PRIMARNI OVOJNINI
English: Final survival analysis Deaths Median overall survival in months (95% CI) p-value* Hazard ratio** (95% CI)
Slovenian: Mediano celokupno preživetje v mesecih (95% IZ) Vrednost p*
English: 6.6 Special precautions for disposal
Slovenian: 6.6 Posebni varnostni ukrepi za ravnanje z zdravilom
English: Tabulated list of adverse reactions
Slovenian: Seznam neželenih učinkov zdravila
English: AST > 20 x ULN were not re-treated.
Slovenian: Bolnikov z zvišanjem koncentracije ALT ali AST na > 20-kratnik zgornje meje normalnih vrednosti niso začeli ponovno zdraviti.
English: Around a fifth of the patients were aged 13 and 14 years.
Slovenian: Približno petina bolnikov je bila stara 13 ali 14 let.
English: What was the conclusion of the CHMP?
Slovenian: Kakšen je zaključek odbora CHMP?
English: What are the consequences for patients in clinical trials?
Slovenian: Kakšne so posledice za bolnike, ki sodelujejo v kliničnih preskušanjih?
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če ste vključeni v klinično preskušanje in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: More information about Abilify is available on EMA's website.
Slovenian: Več informacij o zdravilu Abilify je na voljo na spletni strani agencije EMA.
English: 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.
Slovenian: Ker ta živčna prenašalca sodelujeta pri shizofreniji in bipolarni motnji, lahko aripiprazol pomaga normalizirati njuno delovanje v možganih ter tako zmanjšati psihotične ali manične simptome in preprečiti njihov ponoven pojav.
English: 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.
Slovenian: Čeprav je bila stopnja ponovitve z zdravilom Abilify pri 13- in 14-letnikih podobna kot pri starejših otrocih (21 % oziroma 19 %), je bilo število bolnikov v glavni študiji premajhno, da bi lahko za mlajšo skupino sprejeli trdne zaključke.
English: 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).
Slovenian: Natančen mehanizem njegovega delovanja ni znan, vendar naj bi deloval prek več receptorjev v možganih, v katerih delno posnema ali zavira delovanje živčnih prenašalcev dopamina in 5-hidroksitriptamina (imenovanega tudi serotonin).
English: 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.
Slovenian: Družba je predstavila podatke iz glavne študije, v kateri je 146 mladostnikov s shizofrenijo s stabilnimi simptomi eno leto prejemalo zdravilo Abilify ali placebo (zdravilo brez zdravilne učinkovine).
English: For schizophrenia it is currently approved only for patients aged 15 years and over.
Slovenian: Pri shizofreniji je trenutno odobreno le za bolnike, starejše od 15 let.
English: The CHMP did not consider the data supporting the application sufficient to recommend extending the medicine's use.
Slovenian: Presodil je, da podatki, predloženi v podporo vlogi, niso zadostni, da bi lahko priporočil razširitev uporabe zdravila.
English: The study investigated how effectively Abilify prevented a relapse of their symptoms.
Slovenian: S študijo so proučevali, kako učinkovito je bilo zdravilo Abilify pri preprečevanju ponovnega pojava simptomov.
English: However, the Committee considered that the data could be important for healthcare professionals and recommended their inclusion in Abilify's product information.
Slovenian: Vendar pa je menil, da utegnejo biti podatki pomembni za zdravstvene delavce, in priporočil, da se ti vključijo v informacije o zdravilu Abilify.
English: Abilify is a medicine for treating schizophrenia and bipolar disorder.
Slovenian: Abilify je zdravilo za zdravljenje shizofrenije in bipolarne motnje.