FrancophonIA/ELRC3.0 huggingface dataset:
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: - uncontrollable excessive shopping
Slovenian: - čezmerno nakupovanje ali trošenje denarja, ki ju ne morete nadzorovati,
English: In a clinical trial of oral aripiprazole in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63 % and 37 %, respectively.
Slovenian: V kliničnem preskušanju s peroralnim aripiprazolom pri zdravih preiskovancih je močan zaviralec CYP3A4 (ketokonazol) zvečal AUC aripiprazola za 63 % in Cmax za 37 %.
English: How to take ABILIFY
Slovenian: Kako jemati zdravilo ABILIFY
English: Based on results from trials with oral administration of aripiprazole, aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 L/kg, indicating extensive extravascular distribution.
Slovenian: Porazdelitev Aripiprazol se obsežno porazdeli po telesu in ima navidezni volumen porazdelitve 4,9 l/kg, kar kaže na izdatno zunajžilno porazdelitev.
English: Blood glucose fluctuation Creatine phosphokinase increased
Slovenian: Neznana pogostnost hemoglobina nihanje vrednosti glukoze v krvi zvišana aktivnost kreatinfosfokinaze
English: What you need to know before you are given ABILIFY Do not use ABILIFY
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo ABILIFY Ne uporabljajte zdravila ABILIFY
English: The AUC and Cmax of dehydroaripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively.
Slovenian: AUC aktivnega presnovka dehidroaripiprazola se je zmanjšala za 32 %, njegova Cmax pa za 47 %.
English: In a long-term 26-week placebo-controlled trial, the incidence of EPS was 19 % for aripiprazole-treated patients and 13.1 % for placebo-treated patients.
Slovenian: V dolgoročnem 26-tedenskem s placebom nadzorovanem preskušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 19 % in pri bolnikih, ki so dobivali placebo, 13,1 %.
English: Round and pink, engraved with "A-011" and "30" on one side.
Slovenian: Okrogle oblike in roza barve z vrezano oznako “A-011” in “30” na eni strani.
English: Manic episodes in Bipolar I Disorder: the recommended starting dose for ABILIFY is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Slovenian: Manične epizode pri bipolarni motnji I: priporočeni začetni odmerek zdravila ABILIFY je 15 mg enkrat na dan ne glede na obroke hrane, in sicer kot samostojno zdravilo ali v sklopu kombiniranega zdravljenja (glejte poglavje 5.1).
English: Population pharmacokinetic evaluation of oral aripiprazole has revealed no evidence of clinically relevant effects from smoking on the pharmacokinetics of aripiprazole.
Slovenian: Kajenje Populacijska farmakokinetična raziskava peroralnega aripiprazola ni pokazala klinično pomembnih vplivov kajenja na farmakokinetiko aripiprazola.
English: No dosage adjustment is required for patients with mild to moderate hepatic impairment.
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter odmerka ni treba prilagajati.
English: Each vial contains 9.75 mg aripiprazole.
Slovenian: Ena viala vsebuje 9,75 mg aripiprazola.
English: Renal impairment No dosage adjustment is required in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose for ABILIFY is 10 mg/day administered on a once-a-day schedule without regard to meals.
Slovenian: Manične epizode pri bipolarni motnji I pri mladostnikih, starih 13 let in več: priporočeni odmerek zdravila ABILIFY je 10 mg enkrat na dan ne glede na obrok hrane.
English: Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus allergic, or urticaria)
Slovenian: vključno z oteklino jezika, edem jezika, edem obraza, alergijsko srbenje ali urtikarija)
English: In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13 to 17 years), presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Slovenian: V 6-tedenskem s placebom nadzorovanem preskušanju, ki je vključevalo 302 mladostnika (13 do 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: When concomitant administration of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, the aripiprazole dose should be reduced.
Slovenian: Pri sočasni uporabi močnih zaviralcev CYP3A4 ali CYP2D6 in aripiprazola je treba odmerek aripiprazola zmanjšati.
English: In one short-term (24-hour) placebo-controlled trial involving 291 patients with bipolar disorder presenting with agitation and disturbed behaviours, ABILIFY solution for injection was associated with statistically significant greater improvements in agitation/behavioural symptoms compared to placebo and was similar to the reference arm lorazepam.
Slovenian: 291 bolnikov z bipolarno motnjo, pri katerih je bila prisotna agitacija in vedenjske motnje, je bilo zdravilo ABILIFY raztopina za injiciranje ABILIFY povezano s statistično pomembnim izboljšanjem agitacije/vedenjskih simptomov v primerjavi s placebom in primerljiv z lorazepamom.
English: EU/1/04/276/033 - 50 mL bottle EU/1/04/276/034 - 150 mL bottle EU/1/04/276/035 - 480 mL bottle
Slovenian: EU/1/04/276/033 - 50-ml plastenka EU/1/04/276/034 - 150-ml plastenka EU/1/04/276/035 - 480-ml plastenka
English: ABILIFY 5 mg tablets are rectangular and blue, marked with ‘A-007' and ‘5' on one side.
Slovenian: Tablete ABILIFY 5 mg so pravokotne in modre, označene z 'A-007' in '5' na eni strani.
English: Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in na škatli poleg oznake “Upor.
English: Talk to your doctor about the best way to feed your baby if you are receiving this medicine.
Slovenian: Če prejemate to zdravilo, se z zdravnikom posvetujte o najprimernejših načinih hranjenja otroka.
English: ABILIFY is for oral use.
Slovenian: Zdravilo ABILIFY je namenjeno za peroralno uporabo.
English: Population pharmacokinetic evaluation has revealed no evidence of clinically significant effects from smoking on the pharmacokinetics of aripiprazole.
Slovenian: Kajenje Populacijska farmakokinetična analiza ni pokazala klinično pomembnih učinkov kajenja na farmakokinetiko apiprazola.
English: ABILIFY 30 mg tablets are round and pink, marked with ‘A-011' and ‘30' on one side.
Slovenian: Tablete ABILIFY 30 mg so okrogle in roza, označene z 'A-011' in '30' na eni strani.
English: The administration of ABILIFY solution for injection had no effect on the pharmacokinetics of lorazepam solution for injection when administered concomitantly.
Slovenian: Pri sočasni uporabi zdravila ABILIFY raztopina za injiciranje ne vpliva na farmakokinetiko lorazepama v obliki raztopine za injiciranje.
English: Each mL contains 7.5 mg of aripiprazole.
Slovenian: En ml vsebuje 7,5 mg aripiprazola.
English: Administration of ABILIFY solution for injection was well tolerated and produced no direct target organ toxicity in rats or monkeys after repeated dosing at systemic exposures (AUC) that were 15 and 5 times, respectively, human exposure at the maximum recommended human dose of 30 mg intramuscular.
Slovenian: Podgane in opice so ponavljajoče se odmerke aripiprazola v obliki raztopine za injiciranje dobro prenašale (sistemska izpostavljenost (AUC) je bila pri podganah za 15-krat, pri opicah pa za 5-krat večja od izpostavljenosti človeka po največjem priporočenem intramuskularnem odmerku pri človeku (30 mg)).
English: In another long-term 26-week controlled trial, the incidence of EPS was 14.8 % for aripiprazole-treated patients and 15.1 % for olanzapine-treated patients.
Slovenian: V drugem dolgoročnem 26-tedenskem nadzorovanem preskušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 14,8 % in pri bolnikih, zdravljenih z olanzapinom, 15,1 %.
English: Schizophrenia: the recommended starting dose for ABILIFY is 10 mg/day or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals.
Slovenian: Shizofrenija: priporočeni začetni odmerek zdravila ABILIFY je 10 mg/dan ali 15 mg/dan, vzdrževalni odmerek pa 15 mg/dan, uporabljen enkrat na dan ne glede na obroke.
English: A lower dose of 5.25 mg (0.7 mL) may be given, on the basis of individual clinical status, which should also include consideration of medicinal products already administered either for maintenance or acute treatment (see section 4.5).
Slovenian: ABILIFY v obliki raztopine za injiciranje je pri enkratnem injiciranju učinkovit pri odmerkih v razponu od 5,25 mg do 15 mg. Na osnovi individualnega kliničnega statusa, pri čemer je treba upoštevati tudi že dana zdravila, bodisi zaradi vzdrževalnega bodisi akutnega zdravljenja (glejte poglavje 4.5), lahko bolnik prejme tudi odmerek,
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na enoto odmerka, kar v bistvu pomeni ‘brez natrija'.
English: Aspartame (E 951)
Slovenian: indigotin (E 132)
English: Do not use this medicine after the expiry date which is stated on the bottle and on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in na škatli poleg oznake “Upor.
English: Each carton contains one bottle and both a calibrated polypropylene measuring cup and a calibrated polypropylene low-density polyethylene dropping pipette.
Slovenian: Ena škatla vsebuje 1 plastenko, umerjeno odmerno čašo iz polipropilena in umerjeno kapalko iz polipropilena in polietilena majhne gostote.
English: However, you should not dilute with other liquids or mix with other food prior to taking ABILIFY oral solution.
Slovenian: Vendar pa zdravila ABILIFY pred zaužitjem ne smete redčiti z drugimi tekočinami ali mešati s hrano.
English: ABILIFY tablets contain lactose.
Slovenian: Tablete ABILIFY vsebujejo laktozo.
English: The recommended dose is 9.75 mg (1.3 mL) for the first injection.
Slovenian: Priporočeni odmerek pri prvem injiciranju je 9,75 mg (1,3 ml).
English: However, in a single-dose, intramuscular study of aripiprazole (dose 15 mg) in healthy subjects, administered simultaneously with intramuscular lorazepam (dose 2 mg), the orthostatic hypotension observed was greater with the combination as compared to that observed with lorazepam alone.
Slovenian: Vendar pa je v študiji pri zdravih osebah, ki so prejele enkratni intramuskularni odmerek aripiprazola (15 mg) skupaj z enkratnim intramuskularnim odmerkom lorazepama (2 mg), bila stopnja sedacije pri uporabi kombinacije večja kot pri uporabi lorazepama samega.
English: ABILIFY 7.5 mg/mL solution for injection
Slovenian: ABILIFY 7,5 mg/ml raztopina za injiciranje
English: ABILIFY contains aspartame
Slovenian: Zdravilo ABILIFY vsebuje aspartam
English: Use in children and adolescents The recommended dose for adolescents is 10 mL solution (corresponding to 10 mg aripiprazole)
Slovenian: Uporaba pri otrocih in mladostnikih Priporočeni odmerek za mladostnike je 10 ml raztopine (kar ustreza 10 mg aripiprazola) enkrat na dan, toda vaš zdravnik vam lahko predpiše odmerek, ki je manjši ali večji, do največ 30 ml (tj.
English: extrapyramidal disorder (18.4 %), akathisia (16.0 %), and fatigue (11.8 %); and commonly (≥ 1/100, < 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia.
Slovenian: (16,0 %) in utrujenosti (11,8 %), ki so bili zelo pogosti (≥ 1/10), ter bolečine v zgornjem predelu trebuha, hitrejšega srčnega utripa, povečanja telesne mase, povečanega apetita, trzanja mišic in diskinezije, ki so bili pogosti (≥ 1/100, < 1/10).
English: The oral solution should not be diluted with other liquids or mixed with any food prior to administration.
Slovenian: Peroralne raztopine pred uporabo ni dovoljeno mešati z drugimi tekočinami ali s hrano.
English: ABILIFY orodispersible tablets contain aspartame.
Slovenian: Orodisperzibilne tablete ABILIFY vsebujejo aspartam.
English: - binge eating (eating large amounts of food in a short time period) or compulsive eating
Slovenian: - prenajedanje (uživanje velikih količin hrane v kratkem obdobju) ali kompulzivno uživanje hrane (uživanje večjih količin hrane od normalnih in več, kot je potrebno za potešitev lakote), - nagnjenost k tavanju.
English: ABILIFY 15 mg tablets are round and yellow, marked with ‘A-009' and ‘15' on one side.
Slovenian: Tablete ABILIFY 15 mg so okrogle in rumene, označene z 'A-009' in '15' na eni strani.
English: Population pharmacokinetic evaluation showed no evidence of race-related differences on the pharmacokinetics of aripiprazole.
Slovenian: Rasa Populacijska farmakokinetična analiza ni pokazala klinično pomembnih učinkov rase na farmakokinetiko aripiprazola.
English: Do not stop your treatment just because you feel better.
Slovenian: Čeprav se počutite bolje, zdravljenja ne smete prekiniti.
English: Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including accelerated or malignant.
Slovenian: cerebrovaskularno boleznijo ali stanji, ki ustvarjajo nagnjenost k hipotenziji (dehidracija, hipovolemija in zdravljenje z antihipertenzivi) ali hipertenziji, vključno s pospešeno in maligno hipertenzijo.
English: Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1, 56 × 1, 98 × 1 tablets.
Slovenian: Aluminijski perforirani pretisni omoti za enkratni odmerek v škatlah po 14 × 1, 28 × 1, 49 × 1, 56 × 1, 98 × 1 tablet.
English: ABILIFY 30 mg orodispersible tablets: This medicine contains 6 mg aspartame in each tablet.
Slovenian: ABILIFY 30 mg orodisperzibilne tablete: To zdravilo vsebuje 6 mg aspartama v tableti.
English: Schizophrenia in adolescents aged 15 years and older: the recommended dose for ABILIFY 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 ABILIFY je 10 mg enkrat na dan ne glede na obroke hrane.
English: At equivalent doses, the peak plasma concentrations of aripiprazole (Cmax) from the solution were somewhat higher but the systemic exposure (AUC) was equivalent to tablets.
Slovenian: Ob ekvivalentnih odmerkih je bila največja koncentracija aripiprazola v plazmi (Cmax) pri uporabi raztopine nekoliko večja,
English: ABILIFY 15 mg orodispersible tablets 15 mg: Round and yellow, marked with "A" over "641" on one side and "15" on the other.
Slovenian: ABILIFY 15 mg orodisperzibilne tablete so okrogle oblike in rumene barve, označene z '"A" nad "641"' na eni strani in '15' na drugi.
English: ABILIFY tablets are supplied in perforated unit dose blisters packed in cartons containing 14 × 1, 28 × 1, 49 × 1, 56 × 1, or 98 × 1 tablets.
Slovenian: Zdravilo ABILIFY tablete je na voljo v perforiranih pretisnih omotih v škatlah, ki vsebujejo po 14 × 1, 28 × 1, 49 × 1, 56 × 1 ali 98 × 1 tableto.
English: However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.
Slovenian: Priporočeni odmerek za odrasle je 15 mg enkrat na dan, toda vaš zdravnik vam lahko predpiše odmerek, ki je manjši ali večji, do največ 30 mg enkrat na dan.
English: In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107 %, while Cmax was unchanged.
Slovenian: CYP2D6 (kinidin) zvečal AUC aripiprazola za 107 %, Cmax pa se ni spremenila.
English: In two long-term trials with adolescent (13 to 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: In the adolescent (13 to 17 years) schizophrenia population with aripiprazole exposure of 5 mg 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 mg 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: Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.
Slovenian: Če se pojavi togost ali neprožnost mišic z zvišano telesno temperaturo, znojenje, sprememba duševnega stanja ali zelo hiter ali nepravilen srčni utrip, o tem nemudoma obvestite svojega zdravnika.
English: ABILIFY 15 mg orodispersible tablets: This medicine contains 3 mg aspartame in each tablet.
Slovenian: ABILIFY 15 mg orodisperzibilne tablete: To zdravilo vsebuje 3 mg aspartama v tableti.
English: Rectangular and blue, engraved with "A-007" and "5" on one side.
Slovenian: Pravokotne oblike in modre barve z vrezano oznako “A-007” in “5” na eni strani.
English: Only take other medicines while you are on ABILIFY if your doctor tells you that you can.
Slovenian: Med uporabo zdravila ABILIFY smete druga zdravila uporabljati le, če vam to dovoli zdravnik.
English: What ABILIFY is and what it is used for What you need to know before you take ABILIFY How to take ABILIFY Possible side effects 5 How to store ABILIFY Contents of the pack and other information
Slovenian: Kaj je zdravilo ABILIFY in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ABILIFY Kako uporabljati zdravilo ABILIFY
English: ABILIFY 5 mg tablets ABILIFY 10 mg tablets ABILIFY 15 mg tablets ABILIFY 30 mg tablets
Slovenian: ABILIFY 5 mg tablete ABILIFY 10 mg tablete ABILIFY 15 mg tablete ABILIFY 30 mg tablete
English: The safety and efficacy of ABILIFY solution for injection has not been evaluated in patients with alcohol or medicinal product intoxication (either with prescribed or illicit medicinal products).
Slovenian: Pri bolnikih, ki so se zastrupili z alkoholom ali zdravili (bodisi predpisanimi bodisi nedovoljenimi), varnost in učinkovitost zdravila ABILIFY raztopina za injiciranje nista bili ovrednoteni.
English: EU/1/04/276/033 (1 mg/mL, 50 mL per bottle) EU/1/04/276/034 (1 mg/mL, 150 mL per bottle) EU/1/04/276/035 (1 mg/mL, 480 mL per bottle)
Slovenian: EU/1/04/276/033 (1 mg/ml, 50-ml plastenka) EU/1/04/276/034 (1 mg/ml, 150-ml plastenka) EU/1/04/276/035 (1 mg/ml, 480-ml plastenka)
English: Weight gain has been reported post-marketing among patients prescribed oral aripiprazole.
Slovenian: V obdobju po začetku trženja aripiprazola so pri bolnikih, ki so jim ga predpisali, poročali o povečanju telesne mase.
English: Do not use this medicine after the expiry date which is stated on the carton and on the vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake “Upor.
English: ABILIFY 10 mg orodispersible tablets: This medicine contains 2 mg aspartame in each tablet.
Slovenian: ABILIFY 10 mg orodisperzibilne tablete: To zdravilo vsebuje 2 mg aspartama v tableti.
English: ABILIFY 5 mg tablets ABILIFY 10 mg tablets ABILIFY 15 mg tablets ABILIFY 30 mg tablets aripiprazole
Slovenian: ABILIFY 5 mg tablete ABILIFY 10 mg tablete ABILIFY 15 mg tablete ABILIFY 30 mg tablete aripiprazol
English: Aripiprazole demonstrated statistically superior efficacy compared to placebo on the Aberrant Behaviour Checklist Irritability subscale.
Slovenian: Checklist Irritability subscale”) se je izkazalo, da je aripiprazol statistično učinkovitejši od placeba, vendar pa pomen te ugotovitve za klinično uporabo ostaja neznan.
English: ABILIFY 1 mg/mL oral solution aripiprazole
Slovenian: ABILIFY 1 mg/ml peroralna raztopina aripiprazol
English: ABILIFY is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
Slovenian: Zdravilo ABILIFY je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I pri mladostnikih, starih 13 let in več.
English: Not known increased
Slovenian: Neznana pogostnost
English: Agitation in schizophrenia and Bipolar I Disorder with ABILIFY solution for injection In two short- term (24-hour) placebo-controlled trials involving 554 schizophrenic adult patients presenting with agitation and disturbed behaviours, ABILIFYsolution for injection was associated with statistically significant greater improvements in agitation/behavioural symptoms compared to placebo and was similar to haloperidol.
Slovenian: V dveh kratkotrajnih (24-urnih) s placebom nadzorovanih preskušanjih, ki sta vključevali 554 odraslih bolnikov s shizofrenijo, pri katerih je bila prisotna agitacija in vedenjske motnje, je bilo zdravilo ABILIFY raztopina za injiciranje povezano s statistično pomembnim izboljšanjem agitacije/vedenjskih simptomov v primerjavi s placebom in primerljiv s haloperidolom.
English: ABILIFY 30 mg tablets:
Slovenian: ABILIFY 30 mg tablete:
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0 %),
Slovenian: Manične epizode pri bipolarni motnji I pri mladostnikih, starih 13 let in več Pri mladostnikih z bipolarno motnjo I so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih: somnolence (23,0 %), ekstrapiramidnih motenj (18,4 %), akatizije
English: ABILIFY 7.5 mg/mL solution for injection aripiprazole
Slovenian: ABILIFY 7,5 mg/ml raztopina za injiciranje aripiprazol
English: • The other ingredients are disodium edetate, fructose, glycerin, lactic acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sucrose, purified water, and orange flavour.
Slovenian: metilparahidroksibenzoat (E 218), propilenglikol, propilparahidroksibenzoat (E 216), natrijev hidroksid, saharoza, prečiščena voda in aroma pomaranče.
English: Photosensitivity reaction Alopecia
Slovenian: Bolezni kože in podkožja izpuščaj fotosenzibilnostna reakcija alopecija
English: In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult patients, presenting with positive or negative symptoms, oral aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Slovenian: V treh kratkotrajnih (4- do 6-tedenskih) s placebom nadzorovanih preskušanjih pri 1.228 shizofrenih odraslih bolnikih, ki so imeli pozitivne ali negativne simptome, je peroralni aripiprazol dosegel statistično značilno večje izboljšanje psihotičnih simptomov kot placebo.