FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13-17 years), presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Slovenian: Shizofrenija pri mladostnikih V 6-tedenskem s placebom nadzorovanem preskušanju, ki je vključevalo 302 mladostnika (13-17 let) s shizofrenijo s pozitivnimi in negativnimi simptomi, je bil aripiprazol povezan s statistično značilno večjim izboljšanjem psihotičnih simptomov v primerjavi s placebom.
English: Kaplan-Meier relapse rates at week 16 were 35 % for aripiprazole and 52 % for placebo; the hazard ratio for relapse within 16 weeks (aripiprazole/placebo) was 0.57 (non-statistically significant difference).
Slovenian: Razmerje ogroženosti za ponovitev v 16 tednih (aripiprazol/placebo) je bilo 0,57 (statistično nepomembna razlika).
English: Aripiprazole Accord 5 mg tablets Aripiprazole Accord 10 mg tablets Aripiprazole Accord 15 mg tablets Aripiprazole Accord 30 mg tablets aripiprazole
Slovenian: Aripiprazol Accord 5 mg tablete Aripiprazol Accord 10 mg tablete Aripiprazol Accord 15 mg tablete Aripiprazol Accord 30 mg tablete aripiprazol
English: Schizophrenia in adolescents aged 15 years and older: the recommended dose for Aripiprazole Accord is 10 mg/day administered on a once-a-day schedule without regard to meals.
Slovenian: Shizofrenija pri mladostnikih, starih 15 let in več: priporočeni odmerek zdravila Aripiprazol Accord je 10 mg enkrat na dan ne glede na obroke hrane.
English: When weak inhibitors of CYP3A4 (e.g., diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.
Slovenian: Med sočasno uporabo aripiprazola in šibkih zaviralcev CYP3A4 (npr. diltiazema) ali CYP2D6 (npr. escitaloprama) je mogoče pričakovati zmerno zvišanje koncentracije plazemskega aripiprazola.
English: EU/1/15/1045/017- 30 tablets EU/1/15/1045/018- 100 tablets
Slovenian: EU/1/15/1045/017- 30 tablet EU/1/15/1045/018- 100 tablet
English: EU/1/15/1045/011- 30 tablets EU/1/15/1045/012- 100 tablets
Slovenian: EU/1/15/1045/011- 30 tablet EU/1/15/1045/012- 100 tablet
English: In the pooled trials, the incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) in aripiprazole-treated patients was 27/46 (58.7 %) and 258/298 (86.6 %), respectively.
Slovenian: Podatki združenih preskušanj kažejo, da je bila pri zdravljenju z aripiprazolom pogostnost nizkih vrednosti prolaktina v serumu pri deklicah (< 3 ng/ml) 58,7 % (27/46), pri dečkih (< 2 ng/ml) pa 86,6 % (258/298).
English: What Aripiprazole Accord tablets looks like and contents of the pack
Slovenian: Izgled zdravila Aripiprazol Accord tablete in vsebina pakiranja
English: Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema,
Slovenian: Bolezni imunskega sistema alergijska reakcija (npr. anafilaksijska reakcija, angioedem, vključno z oteklino jezika, edem jezika, edem obraza, srbenje ali urtikarija)
English: Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors, may be expected to have similar effects and similar dose reductions should therefore be applied (see section 4.2).
Slovenian: Pričakovati je mogoče, da imajo drugi močni zaviralci CYP3A4, npr. itrakonazol in zaviralci proteaz HIV, podobne učinke, zato je treba odmerjanje podobno zmanjšati.
English: Manic episodes in Bipolar I Disorder in children and adolescents Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents (10-17 years), who met DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a Y-MRS score  20 at baseline.
Slovenian: Manične epizode pri bipolarni motnji I pri otrocih in mladostnikih Uporabo aripiprazola so raziskovali v 30-tedenskem s placebom nadzorovanem preskušanju, ki je vključevalo 296 otrok in mladostnikov (10-17 let), ki so ustrezali kriterijem DSM-IV za bipolarno motnjo I z maničnimi ali mešanimi epizodami s psihotičnimi lastnostmi ali brez njih, in so imeli v izhodišču oceno  20 po lestvici Y-MRS. Izmed bolnikov, ki so bili vključeni v primarno analizo učinkovitosti, je imelo 139 bolnikov sočasno tudi diagnozo motnje pomanjkanja pozornosti (ADHD - Attention deficit hyperactivity disorder).
English: In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of EPS was 18.2 % for aripiprazole-treated patients and 15.7 % for placebo-treated patients.
Slovenian: V dolgotrajni 26-tedenski vzdrževalni fazi s placebom nadzorovanega preskušanja je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 18,2 %, pri bolnikih, ki so prejemali placebo pa 15,7 %.
English: Aripiprazole Accord is for oral use.
Slovenian: Način uporabe Zdravilo Aripiprazol Accord je namenjeno za peroralno uporabo.
English: To allow the start of the treatment at a low dose you can use an alternative formulation (oral solutionliquid) more suitable than Aripiprazole Accord.The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day.
Slovenian: Da se omogoči začetek zdravljenja v majhnem odmerku, lahko uporabite drugo farmacevtsko obliko (peroralno raztopino − tekočino), ki je primernejša od zdravila Aripiprazol Accord.
English: Each 30 mg tablet contains 177 mg lactose (as monohydrate).
Slovenian: Pomožna(e) snov(i) z znanim učinkom Ena 30 mg tableta vsebuje 177 mg laktoze (v obliki monohidrata).
English: HDPE bottle pack should be used within 30 days after first opening.
Slovenian: HDPE vsebnik je treba uporabiti v 30 dneh po prvem odprtju (za pakiranje po 30 tablet).
English: Aripiprazole Accord with food, drink and alcohol
Slovenian: Zdravilo Aripiprazol Accord skupaj s hrano, pijačo in alkoholom To zdravilo lahko jemljete ne glede na obroke.
English: Each 15 mg tablet contains 88 mg lactose (as monohydrate).
Slovenian: Pomožna(e) snov(i) z znanim učinkom Ena 15 mg tableta vsebuje 88 mg laktoze (v obliki monohidrata).
English: The incidence of hypoprolactinaemia or decreased serum prolactin in patients treated with aripiprazole was 0.4 %, compared with 0.02 % for patients treated with placebo.
Slovenian: Pojavnost hiperprolaktinemije ali znižane ravni prolaktina v krvi pri bolnikih, zdravljenih z aripiprazolom, je bila 0,4 % v primerjavi s skupino s placebom (0,2 %).
English: These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ARIPIPRAZOLE ACCORD, you should see your doctor.
Slovenian: Če opazite kakršen koli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom Aripiprazol Accord, obiščite zdravnika.
English: Each 10 mg tablet contains 59 mg lactose (as monohydrate).
Slovenian: Pomožna(e) snov(i) z znanim učinkom Ena 10 mg tableta vsebuje 59 mg laktoze (v obliki monohidrata).
English: In two long term trials with adolescent (13-17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 37.0 % and 59.4 %, respectively.
Slovenian: Pri dveh dolgotrajnih preskušanjih pri mladostnikih s shizofrenijo in bipolarno motnjo (starosti od 13 do 17 let), ki so se zdravili z aripiprazolom, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah 37,0 % (< 3 ng/ml) in pri moških (< 2 ng/ml) 59,4 %.
English: (for 100's count) Open date:
Slovenian: Datum odprtja:
English: Hydroxypropylcellulose Magnesium stearate Indigo carmine aluminium lake (E132)
Slovenian: Aripiprazol Accord 5 mg tablete laktoza monohidrat mikrokristalna celuloza koruzni škrob hidroksipropilceluloza magnezijev stearat indigotin (E 132)
English: Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n = 99, placebo: n = 44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Slovenian: Trzaji, povezani s Tourettovim sindromom, pri pediatričnih bolnikih (glejte poglavje 4.2) Učinkovitost aripiprazola je bila raziskana pri pediatrični populaciji s Tourettovo motnjo (aripiprazol: n = 99, placebo: n = 44) v 8-tedenski randomizirani, dvojno slepi, s placebom nadzorovani študiji, zasnovani z zdravljenimi skupinami, ki so prejemale nespremenjen odmerek glede na telesno maso posameznika v razponu od 5 mg/dan do 20 mg/dan, z začetnim odmerkom 2 mg. Bolniki so bili stari od 7 do 17 let, izhodiščni rezultat njihovega števila trzajev po skupni oceni resnosti trzajev na lestvici TTS-YYGTSS (angl. Total Tic Severity Score - Yale Global Tic Severity Scale) pa je bil 30.
English: Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain
Slovenian: Splošne težave in spremembe na mestu aplikacije izčrpanost motnje uravnavanja telesne temperature (npr. hipotermija, pireksija) bolečine v prsih periferni edemi
English: • cardiovascular diseases (diseases of the heart and circulation),, family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
Slovenian: • imate srčnožilne bolezni (bolezni srca in ožilja), srčnožilne bolezni v družini, možgansko kap ali
English: In the adolescent (13-17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (<3 ng/ml) and males (< 2 ng/ml) was 25.6 % and 45.0 %, respectively.
Slovenian: Pri populaciji mladostnikov (starosti od 13 do 17 let) s shizofrenijo, ki so največ 72 mesecev izpostavljeni apriprazolu 5 do 30 mg, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah (< 3 ng/ml) 25,6 % in pri moških (< 2 ng/ml) 45,0 %.
English: Each 5 mg tablet contains 63 mg lactose (as monohydrate).
Slovenian: Pomožna(e) snov(i) z znanim učinkom Ena 5 mg tableta vsebuje 63 mg laktoze (v obliki monohidrata).
English: Aripiprazole Accord 15 mg tablets are yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Slovenian: Aripiprazol Accord 15 mg tablete so rumene, okrogle, bikonveksne, neobložene tablete z zaobljenim robom, dolžine približno 7,14 mm, z vtisnjeno oznako “A15” na eni strani in brez oznake na drugi strani.
English: INFORMATION IN BRAILLE Aripiprazole Accord 30 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Aripiprazol Accord 30 mg
English: (for 30's count) HDPE bottle pack should be used within 100 days after first opening.
Slovenian: HDPE vsebnik je treba uporabiti v 100 dneh po prvem odprtju (za pakiranje po 100 tablet).
English: Aripiprazole Accord 30 mg tablets
Slovenian: Aripiprazol Accord 30 mg tablete
English: In the pooled adolescent schizophrenia population (13-17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (<3 ng/ml) and males (< 2 ng/ml) was 29.5 % and 48.3 %, respectively.
Slovenian: V populaciji mladostnikov s shizofrenijo (13-17 let), ki so se zdravili do 2 leti, je bila pogostnost nizke ravni prolaktina v serumu pri ženskah (< 3 ng/ml) 29,5 % in pri moških (< 2 ng/ml) 48,3 %.
English: Grand mal convulsion Serotonin syndrome Speech disorder
Slovenian: Bolezni živčevja akatizija ekstrapiramidne motnje tremor glavobol sedacija somnolenca omotica tardivna diskinezija distonija maligni nevroleptični sindrom (MNS) generalizirana konvulzija serotoninski sindrom motnje govora
English: In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary end-point was weight gain, significantly less patients had at least 7 % weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg) on aripiprazole (n = 18, or 13 % of evaluable patients), compared to olanzapine (n = 45, or 33 % of evaluable patients).
Slovenian: za vsaj 5,6 kg pri povprečni izhodiščni masi ~ 80,5 kg) značilno redkejše pri bolnikih, ki so dobivali aripiprazol, (n = 18 ali 13 % ocenljivih bolnikov) kot pri tistih, ki so dobivali olanzapin (n = 45 ali 33 % ocenljivih bolnikov).
English: INFORMATION IN BRAILLE Aripiprazole Accord 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Aripiprazol Accord 5 mg
English: INFORMATION IN BRAILLE Aripiprazole Accord 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Aripiprazol Accord 10 mg
English: Hydroxypropylcellulose Magnesium stearate Iron oxide yellow (E172)
Slovenian: Aripiprazol Accord 15 mg tablete laktoza monohidrat mikrokristalna celuloza koruzni škrob hidroksipropilceluloza magnezijev stearat rumen železov oksid (E 172)
English: Aripiprazole Accord 10 mg tablets
Slovenian: Aripiprazol Accord 10 mg tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1045/005- 30 tablets EU/1/15/1045/006- 100 tablets
Slovenian: EU/1/15/1045/005- 30 tablet EU/1/15/1045/006- 100 tablet
English: These medicines may increase the risk of side effects or reduce the effect of ARIPIPRAZOLE ACCORD; if you get any unusual symptom taking any of these medicines together with ARIPIPRAZOLE ACCORD you should see your doctor.
Slovenian: Ta zdravila lahko povečajo tveganje za neželene učinke ali zmanjšajo učinek zdravila Aripiprazol Accord.
English: Aripiprazole Accord 30 mg tablets: each tablet contains 30 mg of aripiprazole.
Slovenian: Aripiprazol Accord 30 mg tablete : Ena tableta vsebuje 30 mg aripiprazola.
English: Aripiprazole Accord 30 mg tablets Each tablet contains 30 mg of aripiprazole.
Slovenian: Aripiprazol Accord 30 mg tablete Ena tableta vsebuje 30 mg aripiprazola.
English: In CYP2D6 poor metabolisers, concomitant use of potent inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.When considering concomitant administration of ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient.
Slovenian: Pri osebah, ki slabo presnavljajo s CYP2D6 lahko sočasna uporaba z močnimi zaviralci CYP3A4 povzroči večjo koncentracijo aripiprazola v plazmi kot pri osebah, ki dobro presnavljajo s CYP2D6.
English: Other medicines and Aripiprazole Accord
Slovenian: Shranjevanje zdravila Aripiprazol Accord
English: Aripiprazole Accord 5 mg tablets are blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Slovenian: Aripiprazol Accord 5 mg tablete so modre, bikonveksne, neobložene pravokotniku podobne tablete, dolžine približno 8,1 mm in širine 4,6 mm, z vtisnjeno oznako “A5” na eni strani in brez oznake na drugi strani.
English: Aripiprazole Accord 15 mg tablets
Slovenian: Aripiprazol Accord 15 mg tablete
English: Aripiprazole Accord 5 mg tablets
Slovenian: Aripiprazol Accord 5 mg tablete
English: Aripiprazole Accord 10 mg tablets are pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Slovenian: Aripiprazol Accord 10 mg tablete so roza, bikonveksne, neobložene pravokotniku podobne tablete, dolžine približno 8,1 mm in širine 4,6 mm, z vtisnjeno oznako “A10” na eni strani in brez oznake na drugi strani.
English: Aripiprazole Accord 15 mg tablets Each tablet contains 15 mg of aripiprazole.
Slovenian: Aripiprazol Accord 15 mg tablete Ena tableta vsebuje 15 mg aripiprazola.
English: Aripiprazole Accord 10 mg tablets Each tablet contains 10 mg of aripiprazole.
Slovenian: Aripiprazol Accord 10 mg tablete Ena tableta vsebuje 10 mg aripiprazola.
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 30 mg tablets aripiprazole
Slovenian: IME ZDRAVILA Aripiprazol Accord 30 mg tablete aripiprazol
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Accord 5 mg tablets Each tablet contains 5 mg of aripiprazole.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Aripiprazol Accord 5 mg tablete
English: Aripiprazole Accord 10 mg tablets: each tablet contains 10 mg of aripiprazole.
Slovenian: Aripiprazol Accord 10 mg tablete : Ena tableta vsebuje 10 mg aripiprazola.
English: Aripiprazole Accord 5 mg tablets: each tablet contains 5 mg of aripiprazole.
Slovenian: Aripiprazol Accord 5 mg tablete : Ena tableta vsebuje 5 mg aripiprazola.
English: Pink colored, approximately 9.1 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A30” on one side and another side is plain.
Slovenian: Roza, okrogle, bikonveksne, neobložene tablete z zaobljenim robom, dolžine približno 9,1 mm, z vtisnjeno oznako “A30” na eni strani in brez oznake na drugi strani.
English: Aripiprazole Accord 15 mg tablets: each tablet contains 15 mg of aripiprazole.
Slovenian: Aripiprazol Accord 15 mg tablete : Ena tableta vsebuje 15 mg aripiprazola.
English: Yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Slovenian: Rumene, okrogle, bikonveksne, neobložene tablete z zaobljenim robom, dolžine približno 7,14 mm, z vtisnjeno oznako “A15” na eni strani in brez oznake na drugi strani.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM/ALUMINIUM BLISTERS
Slovenian: ALUMINIJ/ALUMINIJASTI PRETISNI OMOTI
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 10 mg tablets aripiprazole
Slovenian: IME ZDRAVILA Aripiprazol Accord 10 mg tablete aripiprazol
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 15 mg tablets aripiprazole
Slovenian: IME ZDRAVILA Aripiprazol Accord 15 mg tablete aripiprazol
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 5 mg tablets aripiprazole
Slovenian: IME ZDRAVILA Aripiprazol Accord 5 mg tablete aripiprazol
English: • a tendency to wander away.
Slovenian: - nagnjenost k tavanju.
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če imate kateri koli zgoraj omenjeni simptom, se takoj obrnite na zdravnika ali bolnišnico.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of aripiprazole.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 10 mg aripiprazola.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of aripiprazole.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 5 mg aripiprazola.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 15 mg aripiprazola.
English: Jaundice
Slovenian: Distonija
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 30 mg aripiprazola.
English: In two 12-week, placebo- and active-controlled monotherapy trials in patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, aripiprazole demonstrated superior efficacy to placebo at week 3 and a maintenance of effect comparable to lithium or haloperidol at week 12.
Slovenian: V dveh 12-tedenskih s placebom in zdravilno učinkovino nadzorovanih preskušanjih samostojnega zdravljenja pri bolnikih z manično ali mešano epizodo pri bipolarni motnji I s psihotičnimi simptomi ali brez njih se je po 3 tednih izkazalo, da je aripiprazol učinkovitejši od placeba.
English: Hydroxypropylcellulose Magnesium stearate Iron oxide red (E172)
Slovenian: Aripiprazol Accord 10 mg/30 mg tablete laktoza monohidrat mikrokristalna celuloza koruzni škrob hidroksipropilceluloza magnezijev stearat rdeč železov oksid (E 172)
English: INFORMATION IN BRAILLE Aripiprazole Accord 15 mg 17.
Slovenian: PODATKI V BRAILLOVI PISAVI Aripiprazol Accord 15 mg
English: EU/1/15/1045/019 14x1 tablets EU/1/15/1045/020 28x1 tablets EU/1/15/1045/026 49x1 tablets EU/1/15/1045/021 56x1 tablets EU/1/15/1045/022 98x1 tablets
Slovenian: EU/1/15/1045/019 14x1 tableta EU/1/15/1045/020 28x1 tableta EU/1/15/1045/026 49x1 tableta EU/1/15/1045/021 56x1 tableta EU/1/15/1045/022 98x1 tableta
English: EU/1/15/1045/001 14x1 tablets EU/1/15/1045/002 28x1 tablets EU/1/15/1045/023 49x1 tablets EU/1/15/1045/003 56x1 tablets EU/1/15/1045/004 98x1 tablets
Slovenian: EU/1/15/1045/001 14x1 tableta EU/1/15/1045/002 28x1 tableta EU/1/15/1045/023 49x1 tableta EU/1/15/1045/003 56x1 tableta EU/1/15/1045/004 98x1 tableta
English: EU/1/15/1045/013 14x1 tablets EU/1/15/1045/014 28x1 tablets EU/1/15/1045/025 49x1 tablets EU/1/15/1045/015 56x1 tablets EU/1/15/1045/016 98x1 tablets
Slovenian: EU/1/15/1045/013 14x1 tableta EU/1/15/1045/014 28x1 tableta EU/1/15/1045/025 49x1 tableta EU/1/15/1045/015 56x1 tableta EU/1/15/1045/016 98x1 tableta
English: Drug withdrawal syndrome neonatal (see section 4.6)
Slovenian: Motnje v času nosečnosti, puerperija in perinatalnem obdobju sindrom odtegnitve zdravila pri novorojenčku (glejte poglavje 4.6)
English: EU/1/15/1045/007 14x1 tablets EU/1/15/1045/008 28x1 tablets EU/1/15/1045/024 49x1 tablets EU/1/15/1045/009 56x1 tablets EU/1/15/1045/010 98x1 tablets
Slovenian: EU/1/15/1045/007 14x1 tableta EU/1/15/1045/008 28x1 tableta EU/1/15/1045/024 49x1 tableta EU/1/15/1045/009 56x1 tableta EU/1/15/1045/010 98x1 tableta
English: Leukopenia Neutropenia Thrombocytopenia
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva rabdomioliza mialgija togost
English: Pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Slovenian: Roza, bikonveksne, neobložene pravokotniku podobne tablete, dolžine približno 8,1 mm in širine 4,6 mm, z vtisnjeno oznako “A10” na eni strani in brez oznake na drugi strani.
English: In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56-99 years) of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, patients treated with aripiprazole were at increased risk of death compared to placebo.
Slovenian: Večja umrljivost V treh s placebom nadzorovanih preskušanjih (n = 938, povprečna starost: 82,4 leta, razpon: 56-99 let)
English: Blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Slovenian: Modre, bikonveksne, neobložene pravokotniku podobne tablete, dolžine približno 8,1 mm in širine 4,6 mm, z vtisnjeno oznako “A5” na eni strani in brez oznake na drugi strani.
English: The application was withdrawn after ‘day 90'.
Slovenian: Vloga je bila umaknjena po „90.
English: EMEA/H/C/000169/WS/132/G
Slovenian: EMEA/H/C/000169/WS/132/G EMEA/H/C/000255/WS/132/G
English: This means that the CHMP had eval documentation provided by the company and formulated lists of questions.
Slovenian: To pomeni, da je CHMP ocenil dokumentacijo, ki mu jo je družba predložila, in oblikoval sezname vprašanj.
English: a clinical trial and need more information about your treatment, contact the doctor who is
Slovenian: Če ste vključeni v klinično preskušanje in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: About half of the patients took the capsule, and half were tre for 76 weeks.
Slovenian: 76 tednov je približno polovica bolnikov jemala kapsule, polovica pa jih je bila zdravljenih z obliži.
English: What was the recommendation of the CHMP at that tim
Slovenian: Kakšno je bilo takrat priporočilo CHMP?
English: The Committee therefore considered that the pharmacokinetic data were not sufficient to draw conclusions on the effectiveness of the patch and that additional data would be required.
Slovenian: Zato je menil, da farmakokinetični podatki niso bili zadostni za sklepanje o učinkovitosti obliža in da so potrebni dodatni podatki.
English: es this withdrawal have for patients in clinical trials?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih?
English: indications?
Slovenian: dnevu“.