FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies, 10 mg/day to 30 mg/day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan).
Slovenian: V kliničnih študijah odmerki od 10 mg do 30 mg aripiprazola na dan niso pomembno vplivali na presnovo substratov CYP2D6 (razmerje dekstrometorfan/3-metoksimorfinan), CYP2C9 (varfarin), CYP2C19 (omeprazol) ali CYP3A4 (dekstrometorfan).
English: The safety profile in a 26-week open-label extension trial was similar to that observed in the shortterm, placebo-controlled trial.
Slovenian: podaljšanem preskušanju je bil profil varnosti podoben profilu varnosti v kratkotrajnem, s placebom nadzorovanem preskušanju.
English: • withdrawal symptoms in newborn babies in case of exposure during pregnancy,
Slovenian: • odtegnitveni simptomi pri novorojenčkih v primeru izpostavljenosti zdravilu v času nosečnosti, • dolgotrajna in/ali boleča erekcija,
English: Patients who have taken too much aripiprazole have experienced the following symptoms:
Slovenian: Bolniki, ki so vzeli večji odmerek aripiprazola, kot bi smeli, so imeli naslednje simptome:
English: Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
Slovenian: vzdrževanje ustreznega stanja dihal, oksigenacijo in ventilacijo ter obvladovanje simptomov.
English: Always take the tablet with water and swallow it whole.
Slovenian: Ni pomembno, ali tableto vzamete s hrano ali brez nje, vedno pa jo vzemite z vodo in jo pogoltnite celo.
English: Neuroleptic Malignant Syndrome Grand mal convulsion Serotonin syndrome Speech disorder
Slovenian: Bolezni živčevja akatizija ekstrapiramidne motnje tremor glavobol sedacija somnolenca omotica tardivna diskinezija distonija nevroleptični maligni sindrom generalizirana konvulzija serotoninski sindrom motnje govora
English: These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings.
Slovenian: kot so odvisnost od hazardiranja, čezmerno uživanje hrane ali trošenje denarja, nenormalno povečan libido ali preokupacija z mislimi na spolnost ali spolnimi občutki.
English: In clinical studies, oral doses of 10 mg/day to 30 mg/day of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan).
Slovenian: V kliničnih študijah peroralni odmerki od 10 mg do 30 mg aripiprazola na dan niso pomembno vplivali na presnovo substratov CYP2D6 (razmerje dekstrometorfan/3-metoksimorfinan), CYP2C9 (varfarin), CYP2C19 (omeprazol) ali CYP3A4 (dekstrometorfan).
English: All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to
Slovenian: Vsi neželeni učinki zdravila so našteti po organskih sistemih in pogostnosti: zelo pogosti (≥ 1/10),
English: Schizophrenia: in a long-term 52-week controlled trial, aripiprazole-treated patients had an overalllower incidence (25.8 %) of EPS including Parkinsonism, akathisia, dystonia and dyskinesia compared with those treated with haloperidol (57.3 %).
Slovenian: Shizofrenija: v dolgoročnem 52-tedenskem nadzorovanem preskušanju je bila celotna incidenca EPS (vključno s parkinsonizmom, akatizijo, distonijo in diskinezijo) manjša (25,8 %) pri bolnikih, ki so dobivali aripiprazol, kot pri tistih, ki so dobivali haloperidol (57,3 %).
English: Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia.
Slovenian: Pri bolnikih s tveganjem za aspiracijsko pljučnicoje treba aripiprazol uporabljati previdno.
English: A vial contains 9.75 mg (1.3 mL) aripiprazole.
Slovenian: Viala vsebuje 9,75 mg (1,3 ml) aripiprazola.
English: Aripiprazole group showed an improvement of 14.97 on TTS-YGTSS change from baseline to week 10 as compared with an improvement of 9.62 in the placebo group.
Slovenian: Pri skupini, ki je prejemala aripiprazol, je bilo 10. teden vidno izboljšanje za 14,97 točk po lestvici TTS-YGTSS od izhodiščne vrednosti, v primerjavi z izboljšanjem za 9,62 točke pri skupini, ki je prejemala placebo.
English: Manic episodes in Bipolar I Disorder: in a 12-week controlled trial, the incidence of EPS was 23.5 % for aripiprazole-treated patients and 53.3 % for haloperidol-treated patients.
Slovenian: Manične epizode pri bipolarni motnji I: v 12-tedenskem nadzorovanem preskušanju je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 23,5 %, pri bolnikih, ki so se zdravili s haloperidolom pa 53,3 %.
English: No specific interaction studies have been performed with ABILIFY solution for injection.
Slovenian: Študij medsebojnega delovanja z zdravilom ABILIFY raztopina za injiciranje niso izvedli.
English: Upon discontinuation of the CYP2D6 or CYP3A4 inhibitor, the dosage of aripiprazole should be increased to the level prior to the initiation of the concomitant therapy.
Slovenian: Po prenehanju zdravljenja z zaviralcem CYP2D6 ali CYP3A4 je treba odmerjanje aripiprazola zvečati na raven, kakršna je bila pred uvedbo sočasne terapije.
English: 14 × 1 orodispersible tablets 28 × 1 orodispersible tablets 49 × 1 orodispersible tablets
Slovenian: 14 × 1 orodisperzibilna tableta 28 × 1 orodisperzibilna tableta 49 × 1 orodisperzibilna tableta
English: An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of hydroxy metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 mg/kg/day to 125 mg/kg/day (1 to 3 times the mean steady-state AUC at the maximum recommended clinical dose or 16 to 81 times the maximum recommended human dose based on mg/m2).
Slovenian: Dodaten izsledek je bila holelitiaza zaradi precipitacije sulfatnih konjugatov hidroksipresnovkov aripiprazola v žolču opic po ponavljajočem odmerjanju od 25 mg/kg/dan do 125 mg/kg/dan (1- do 3kratna srednja AUC v stanju dinamičnega ravnovesja ob največjem priporočenem kliničnem odmerku ali 16- do 81-kratni največji priporočeni odmerek za človeka glede na mg/m2).
English: Immediately upon opening the blister, using dry hands, remove the tablet and place the entire orodispersible tablet on the tongue.
Slovenian: Takoj ko odprete omot, orodisperzibilno tableto s suhimi rokami primite in celo položite na jezik.
English: Each carton contains one single-use type I glass vial with a rubber butyl stopper and a "tear-off" aluminium seal.
Slovenian: Ena škatla vsebuje 1 vialo za enkratno uporabo iz stekla tipa I, zaprto z zamaškom iz butilne gume in aluminijasto odtržno zaporko.
English: Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalysed by CYP3A4.
Slovenian: Na podlagi raziskav in vitro so za dehidrogenacijo in hidroksilacijo aripiprazola odgovorni encimi CYP3A4 in CYP2D6, N-dealkilacijo pa katalizira
English: ABILIFY is not recommended for use in patients with schizophrenia below 15 years of age due to insufficient data on safety and efficacy (see sections 4.8 and 5.1).
Slovenian: Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila ABILIFY pri bolnikih s shizofrenijo, mlajših od 15 let, ni priporočljiva (glejte poglavji 4.8 in 5.1).
English: Dosing in these trials was initiated at 2 mg/day, increased to 5 mg/day after one week, and increased by 5 mg/day in weekly increments to the target dose.
Slovenian: Odmerek so po enem tednu povečali do 5 mg/dan, nato pa so ga do ciljnega odmerka povečevali za
English: • The other ingredients are calcium silicate, croscarmellose sodium, crospovidone, silicon dioxide, xylitol, microcrystalline cellulose, aspartame, acesulfame potassium, vanilla flavour (contains lactose), tartaric acid and magnesium stearate.
Slovenian: • Druge sestavine zdravila so kalcijev silikat, premreženi natrijev karmelozat, krospovidon, silicijev dioksid, ksilitol, mikrokristalna celuloza, aspartam, kalcijev acesulfamat, aroma vanilije (vsebuje laktozo), vinska kislina, magnezijev stearat.
English: Patients with attention deficit hyperactivity disorder (ADHD) comorbidity Despite the high comorbidity frequency of Bipolar I Disorder and ADHD, very limited safety data are available on concomitant use of aripiprazole and stimulants; therefore, extreme caution should be taken when these medicinal products are co-administered.
Slovenian: Bolniki s sočasno motnjo pomanjkanja pozornosti (ADHD - Attention deficit hyperactivity disorder) Kljub pogosti sočasni obolevnosti za bipolarno motnjo I in motnjo pomanjkanja pozornosti je na voljo zelo malo podatkov o sočasni uporabi aripiprazola in stimulansov.
English: • antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine,
Slovenian: • antidepresive ali pripravke rastlinskega izvora proti depresiji in tesnobnosti (kot so fluoksetin,
English: • Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include: strong impulse to gamble excessively despite serious personal or family consequences altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive uncontrollable excessive shopping binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) a tendency to wander away.
Slovenian: - močna želja po čezmernem hazardiranju ne glede na posledice za vas ali za družino, - spremenjeno ali povečano spolno zanimanje in vedenje, ki vam ali drugim povzroča znatno zaskrbljenost, na primer povečan libido, - čezmerno nakupovanje ali trošenje denarja, ki ju ne morete nadzorovati, - 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: Oral solution 50 mL oral solution 150 mL oral solution 480 mL oral solution
Slovenian: Peroralna raztopina 50 ml peroralne raztopine 150 ml peroralne raztopine 480 ml peroralne raztopine
English: What ABILIFY is and what it is used for What you need to know before you take ABILIFY How to take ABILIFY
Slovenian: Kaj je zdravilo ABILIFY in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ABILIFY Kako jemati zdravilo ABILIFY
English: Intramuscular use.
Slovenian: intramuskularna uporaba
English: The oral solution contains fructose and sucrose.
Slovenian: Peroralna raztopina vsebuje fruktozo in saharozo.
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželenih učinkov Odrasli
English: • sudden unexplained death,
Slovenian: • nenadna nepojasnjena smrt, • nepravilno bitje srca, ki lahko ogrozi življenje,
English: Irritability associated with autistic disorder in paediatric patients (see section 4.2) Aripiprazole was studied in patients aged 6 to 17 years in two 8-week, placebo-controlled trials [one flexible-dose (2 mg/day to 15 mg/day) and one fixed-dose (5 mg/day, 10 mg/day, or 15 mg/day)] and in one 52-week open-label trial.
Slovenian: Uporabo aripiprazola so pri bolnikih, starih od 6 do 17 let, raziskovali v dveh 8-tedenskih, s placebom nadzorovanih preskušanjih [v enem z uporabo fleksibilnega odmerka (od 2 mg/dan do 15 mg/dan), v drugem pa z uporabo fiksnega odmerka (5 mg/dan, 10 mg/dan ali 15 mg/dan)] in v enem 52tedenskem odprtem preskušanju.
English: Oral solution Clear, colourless to light yellow liquid solution.
Slovenian: Bistra, brezbarvna do rumenkasta tekočina.
English: • accidental inhalation of food with risk of pneumonia (lung infection),
Slovenian: • naključno vdihanje hrane s tveganjem za pljučnico (okužba pljuč), • krči mišic v grlu,
English: A second injection may be administered 2 hours after the first injection, on the basis of individual clinical status and no more than three injections should be given in any 24-hour period.
Slovenian: Na osnovi individualnega kliničnega statusa lahko bolnik prejme drugo injekcijo 2 uri po prvi.
English: Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate
Slovenian: Jedro tablete laktoza monohidrat koruzni škrob mikrokristalna celuloza hidroksipropilceluloza magnezijev stearat
English: Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13 to 17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo):
Slovenian: V kratkotrajnem, s placebom nadzorovanem kliničnem preskušanju, ki je vključevalo 302 mladostnika (13 do 17 let) s shizofrenijo, so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih neželenih učinkov, ki so bili pri mladostnikih, ki so prejemali aripiprazol, pogostejši kot pri odraslih, ki so prejemali aripiprazol (in pogostejši kot pri placebu):
English: This medicine can be given regardless of meals.
Slovenian: Zdravilo ABILIFY se lahko daje ne glede na obroke.
English: • uncontrollable twitching, jerking or writhing movements, restless legs,
Slovenian: • neobvladljivo trzanje, krčeviti gibi, nemirne noge,
English: ABILIFY 5 mg tablets Indigo carmine aluminium lake (E 132)
Slovenian: ABILIFY 5 mg tablete indigotin (E 132)
English: Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater than 1 in 100 patients).
Slovenian: Neželeni učinki pri mladostnikih, starih 13 let in starejših, so bili po pogostnosti in vrsti podobni neželenim učinkom pri odraslih, z izjemo naslednjih: zaspanost, nenadzorovani trzaji ali nehotni gibi, nemirnost in utrujenost, ki so bili zelo pogosti (prisotni pri več kot 1 od 10 bolnikov), ter bolečina v zgornjem predelu trebuha, suha usta, hiter srčni utrip, povečanje telesne mase, povečan apetit, trzanje mišic, nenadzorovano gibanje udov in omotica, še posebej pri vstajanju iz ležečega ali sedečega položaja, ki so bili pogosti (prisotni pri več kot 1 od 100 bolnikov).
English: If you forget to take ABILIFY
Slovenian: Če ste pozabili vzeti zdravilo ABILIFY
English: These included: dose-dependent adrenocortical toxicity (lipofuscin pigment accumulation and/or parenchymal cell loss) in rats after 104 weeks at 20 mg/kg/day to 60 mg/kg/day (3 to 10 times the mean steady-state AUC at the maximum recommended human dose) and increased adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas in female rats at 60 mg/kg/day (10 times the mean steady-state AUC at the maximum recommended human dose).
Slovenian: 104 tednih odmerjanja od 20 mg/kg/dan do 60 mg/kg/dan (od 3- do 10-kratna srednja AUC v stanju dinamičnega ravnovesja ob največjem priporočenem odmerku za človeka) ter zvečana pogostnost adrenokortikalnih karcinomov in kombiniranih adrenokortikalnih adenomov/karcinomov pri podganjih samicah ob odmerjanju 60 mg/kg/dan (10-kratna srednja AUC v stanju dinamičnega ravnovesja ob največjem priporočenem odmerku za človeka).
English: What you need to know before you take ABILIFY Do not take ABILIFY
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo ABILIFY Ne jemljite zdravila ABILIFY
English: ABILIFY solution for injection is for intramuscular use.
Slovenian: Raztopina za injiciranje zdravila ABILIFY je namenjena za intramuskularno uporabo.
English: If you are taking ABILIFY, your doctor will discuss with you whether you should breast-feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding.
Slovenian: Če prejemate zdravilo ABILIFY, vam bo zdravnik pomagal pri odločitvi glede dojenja z upoštevanjem prednosti dojenja za otroka in prednosti zdravljenja za vas.
English: ABILIFY contains fructose and sucrose
Slovenian: Zdravilo ABILIFY vsebuje fruktozo in saharozo
English: Red iron oxide (E 172)
Slovenian: rdeči železov oksid (E 172)
English: Patients who have been given too much aripiprazole have experienced the following symptoms:
Slovenian: Bolniki, ki so prejeli večji odmerek aripiprazola, kot bi smeli, so imeli naslednje simptome:
English: Before treatment with ABILIFY, tell your doctor if you suffer from
Slovenian: Pred začetkom zdravljenja z zdravilom ABILIFY morate obvestiti zdravnika, če:
English: ABILIFY is effective in a dose range of 10 mg/day to 30 mg/day (i.e. 10 mL to 30 mL solution/day).
Slovenian: Zdravilo ABILIFY je učinkovito v razponu odmerkov od 10 mg/dan do 30 mg/dan (tj. od
English: The recommended initial dose for ABILIFY solution for injection is 9.75 mg (1.3 mL), administered as a single intramuscular injection.
Slovenian: Priporočeni začetni odmerek zdravilom ABILIFY raztopina za injiciranje je 9,75 mg (1,3 ml).
English: Aripiprazole doses ranging from 0.5 mg to 30 mg administered once a day to healthy subjects for 2 weeks produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor ligand, to the caudate and putamen detected by positron emission tomography.
Slovenian: S pozitronsko emisijsko tomografijo so pokazali, da je 2-tedenska uporaba odmerkov od 0,5 mg do 30 mg aripiprazola enkrat na dan pri zdravih preiskovancih povzročila od odmerka odvisno zmanjšanje vezave 11C-rakloprida, liganda receptorjev D2/D3, v nucleusu caudatusu in putamnu.
English: • The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose and magnesium stearate.
Slovenian: • Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, hidroksipropilceluloza, magnezijev stearat.
English: • The other ingredients are sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injections.
Slovenian: • Druge sestavine zdravila so sulfobutileter betaciklodekstrin (SBECD), vinska kislina, natrijev hidroksid in voda za injekcije.
English: If you stop taking ABILIFY
Slovenian: Če prenehate jemati zdravilo ABILIFY
English: The efficacy of aripiprazole in paediatric subjects with Tourette's syndrome (aripiprazole: n = 32, placebo: n = 29) was also evaluated over a flexible dose range of 2 mg/day to 20 mg/day and a starting dose of 2 mg, in a 10 week, randomised, double blind, placebo-controlled study conducted in SouthKorea.
Slovenian: n = 29) je bila ocenjena tudi s prilagodljivim odmerkom v razponu od 2 mg/dan do 20 mg/dan in začetnim odmerkom 2 mg v 10-tedenski randomizirani, dvojno slepi, s placebom nadzorovani študiji, izvedeni v Južni Koreji.
English: In a 26-week, placebo-controlled trial in adult stabilised patients with chronic schizophrenia, aripiprazole had significantly greater reduction in relapse rate, 34 % in aripiprazole group and 57 % in placebo.
Slovenian: V 26-tedenskem, s placebom nadzorovanem preskušanju stabiliziranih odraslih bolnikov s kronično shizofrenijo je peroralni aripiprazol značilno bolj zmanjšal delež recidivov: v skupini, ki je dobivala aripiprazol peroralno, jih je bilo 34 %, v tisti, ki je dobivala placebo, pa 57 %.
English: These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ABILIFY, you should see your doctor.
Slovenian: Če opazite kakršen koli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom ABILIFY, obiščite zdravnika.
English: Yellow iron oxide (E 172)
Slovenian: rumeni železov oksid (E 172)
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: Other urges, reported, include: increased sexual urges, compulsive shopping, binge or compulsive eating, and other impulsive and compulsive behaviours.
Slovenian: kompulzivno nakupovanje, kompulzivno prenajedanje in drugo impulzivno in kompulzivno vedenje.
English: • abnormal muscle breakdown which can lead to kidney problems,
Slovenian: • nenormalna razgradnja mišic, ki lahko povzroči težave z ledvicami, • bolečine v mišicah,
English: Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
Slovenian: Preobčutljivost Tudi pri aripiprazolu se lahko pojavijo preobčutljivostne reakcije v obliki simptomov alergije (glejte poglavje 4.8).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Slovenian: Predklinični podatki o varnosti na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: However, the clinical relevance of this finding has not been established.
Slovenian: vendar ta učinek ne velja za klinično pomembnega.
English: However, the oral solution should not be diluted with other liquids or mixed with any food prior to administration.
Slovenian: Vendar peroralne raztopine pred zaužitjem ne smete redčiti z drugimi tekočinami ali mešati s hrano.
English: Non-clinical data reveal no special hazard for humans based on conventional oral aripiprazole studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Slovenian: Predklinični podatki o varnosti peroralnega aripiprazola na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
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 intensity of sedation was greater with the combination as compared to that observed with aripiprazole 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 aripiprazola samega.
English: Round and yellow, engraved with "A-009" and "15" on one side.
Slovenian: Okrogle oblike in rumene barve z vrezano oznako “A-009” in “15” na eni strani.
English: • difficulty sleeping,
Slovenian: • sladkorna bolezen, • težave s spanjem,
English: - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
Slovenian: - močna želja po čezmernem hazardiranju ne glede na posledice za vas ali za družino, - spremenjeno ali povečano spolno zanimanje in vedenje, ki vam ali drugim povzroča znatno zaskrbljenost, na primer povečan libido,
English: Drug withdrawal syndrome neonatal (see section 4.6)
Slovenian: puerperija in perinatalnem obdobju sindrom odtegnitve zdravila pri novorojenčku (glejte poglavje 4.6)