FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 52-week, placebo-controlled trial, in patients with a current manic or mixed episode of Bipolar I Disorder who achieved sustained remission (Young Mania Rating Scale [YMRS] and MADRS with total scores ≤ 12) on aripiprazole (10 mg/day to 30 mg/day) adjunctive to lithium or valproate for 12 consecutive weeks, adjunctive aripiprazole demonstrated superiority over placebo with a 46 % decreased risk (hazard ratio of 0.54) in preventing bipolar recurrence and a 65 % decreased risk (hazard ratio of 0.35) in preventing recurrence into mania over adjunctive placebo but failed to demonstrate superiority over placebo in preventing recurrence into depression.
Slovenian: [YMRS] in MADRS), se je dodatno zdravljenje z aripiprazolom izkazalo za učinkovitejše od dodatka placeba, s 46 % zmanjšanjem tveganja (razmerje ogroženosti (RO) 0,54) za ponovitev bipolarne motnje in 65 % zmanjšanjem tveganja (razmerje ogroženosti (RO) 0,35) za ponovitev manične epizode, pri preprečevanju ponovitve depresivne epizode pa se dodatno zdravljenje z aripiprazolom ni izkazalo za boljše od placeba.
English: In clinical trials of treatment with oral aripiprazole, the incidence of QT prolongation was comparable to placebo.
Slovenian: Incidenca podaljšanja intervala QT je bila v kliničnih preskušanjih zdravljenj s peroralnim aripiprazolom primerljiva s placebom.
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: Manic episodes in Bipolar I Disorder: the recommended starting dose for ABILIFY is 15 mg (i.e. 15 mL solution/day) administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Slovenian: Največji dnevni odmerek ne sme preseči 30 mg. Manične epizode pri bipolarni motnji I: priporočeni začetni odmerek zdravila ABILIFY je 15 mg enkrat na dan (to je 15 ml raztopine/dan) ne glede na obroke hrane, in sicer kot samostojno zdravilo ali v sklopu kombiniranega zdravljenja (glejte poglavje 5.1).
English: ABILIFY 5 mg tablets Each tablet contains 5 mg of aripiprazole.
Slovenian: ABILIFY 5 mg tablete Ena tableta vsebuje 5 mg aripiprazola.
English: Aripiprazole administered intramuscularly as a single-dose to healthy subjects is well absorbed and has an absolute bioavailability of 100 %.
Slovenian: Po intramuskularni aplikaciji enega samega odmerka aripiprazola zdravim osebam je bila absorpcijadobra.
English: Rectangular and pink, engraved with "A-008" and "10" on one side.
Slovenian: Pravokotne oblike in roza barve z vrezano oznako “A-008” in “10” na eni strani.
English: OUTER CARTON AND BOTTLE LABEL
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: Pregnancy, puerperium and perinatal conditions
Slovenian: Motnje reprodukcije in dojk priapizem
English: ABILIFY 10 mg tablets are rectangular and pink, marked with ‘A-008' and ‘10' on one side.
Slovenian: Tablete ABILIFY 10 mg so pravokotne in roza, označene z 'A-008' in '10' na eni strani.
English: Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1 tablets.
Slovenian: Aluminijski perforirani pretisni omoti za enkratni odmerek v škatlah po 14 × 1, 28 × 1, 49 × 1 tableta.
English: Overall, 1.3 % of aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of placebo-treated patients in these trials.
Slovenian: 1,3 % bolnikov, zdravljenih z aripiprazolom, in pri 0,6 % bolnikov, ki so dobivali placebo.
English: ABILIFY 30 mg tablets
Slovenian: ABILIFY 30 mg tablete
English: ABILIFY 10 mg orodispersible tablets Each orodispersible tablet contains 10 mg of aripiprazole.
Slovenian: ABILIFY 10 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 10 mg aripiprazola.
English: In the pooled adolescent schizophrenia population (13 to 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 do 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: No cases of overdose associated with adverse reactions were reported in clinical studies with ABILIFY solution for injection.
Slovenian: V kliničnih študijah z zdravilom ABILIFY raztopina za injiciranje niso poročali o primerih prevelikega odmerjanja, povezanimi z neželenimi učinki.
English: ABILIFY orodispersible tablets contain lactose.
Slovenian: Orodisperzibilne tablete ABILIFY vsebujejo laktozo.
English: ABILIFY 10 mg tablets:
Slovenian: ABILIFY 10 mg tablete:
English: Each mL contains 1 mg of aripiprazole.
Slovenian: En mililiter vsebuje 1 mg aripiprazola.
English: ABILIFY 15 mg orodispersible tablets Each orodispersible tablet contains 15 mg of aripiprazole.
Slovenian: ABILIFY 15 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 15 mg aripiprazola.
English: The oral solution contains sodium.
Slovenian: Peroralna raztopina vsebuje natrij.
English: ABILIFY 10 mg tablets
Slovenian: ABILIFY 10 mg tablete
English: Excipient with known effect 62.18 mg lactose (as monohydrate) per tablet
Slovenian: 62,18 mg laktoze (v obliki monohidrata) na tableto ABILIFY 15 mg tablete
English: ABILIFY solution for injection contains sodium.
Slovenian: Raztopina za injiciranje ABILIFY vsebuje natrij.
English: ABILIFY 15 mg tablets:
Slovenian: ABILIFY 15 mg tablete:
English: Rhabdomyolysis Myalgia
Slovenian: Peroralna raztopina
English: Package leaflet: Information for the user ABILIFY 7.5 mg/mL solution for injection aripiprazole
Slovenian: Navodilo za uporabo ABILIFY 7,5 mg/ml raztopina za injiciranje aripiprazol
English: Package leaflet: Information for the user ABILIFY 1 mg/mL oral solution aripiprazole
Slovenian: Navodilo za uporabo ABILIFY 1 mg/ml peroralna raztopina aripiprazol
English: ABILIFY 15 mg tablets
Slovenian: ABILIFY 15 mg tablete
English: ABILIFY 5 mg tablets:
Slovenian: ABILIFY 5 mg tablete:
English: Aripiprazole is well absorbed when administered orally as the solution.
Slovenian: Peroralno uporabljeni aripiprazol v obliki raztopine se dobro absorbira.
English: ABILIFY contains lactose
Slovenian: Zdravilo ABILIFY vsebuje laktozo
English: Solution for injection Clear, colourless, aqueous solution.
Slovenian: Bistra, brezbarvna, vodna raztopina.
English: Medicines that increase the level of serotonin are typically used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine and pain:
Slovenian: Zdravila, ki povečajo raven serotonina, navadno uporabljamo za bolezni, vključno z depresijo,
English: Aspiration pneumonia Laryngospasm Oropharyngeal spasm
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kolcanje aspiracijska pljučnica laringospazem orofaringealni spazem
English: Mouth dry
Slovenian: Okvara jeter
English: ABILIFY 30 mg tablets aripiprazole
Slovenian: ABILIFY 30 mg tablete aripiprazol
English: Each orodispersible tablet contains 30 mg of aripiprazole.
Slovenian: Ena orodisperzibilna tableta vsebuje 30 mg aripiprazola.
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
English: Each tablet contains 30 mg of aripiprazole.
Slovenian: Ena tableta vsebuje 30 mg aripiprazola.
English: Each tablet contains 5 mg of aripiprazole.
Slovenian: Ena tableta vsebuje 5 mg aripiprazola.
English: The recommended dose for adults is 15 mL solution (corresponding to 15 mg aripiprazole) once a day.
Slovenian: Priporočeni odmerek za odrasle je 15 ml raztopine (kar ustreza 15 mg aripiprazola) enkrat na dan, toda vaš zdravnik vam lahko predpiše odmerek, ki je manjši ali večji, do največ 30 mg (tj. 30 ml)
English: Hepatic failure Hepatitis Jaundice
Slovenian: žolčnika in žolčevodov odpoved jeter hepatitis zlatenica
English: ABILIFY 5 mg tablets
Slovenian: ABILIFY 5 mg tablete
English: EU/1/04/276/030 (30 mg, 14 × 1 orodispersible tablets) EU/1/04/276/031 (30 mg, 28 × 1 orodispersible tablets) EU/1/04/276/032 (30 mg, 49 × 1 orodispersible tablets)
Slovenian: EU/1/04/276/030 (30 mg, 14 × 1 orodisperzibilna tableta) EU/1/04/276/031 (30 mg, 28 × 1 orodisperzibilna tableta) EU/1/04/276/032 (30 mg, 49 × 1 orodisperzibilna tableta)
English: EU/1/04/276/016 (30 mg, 14 × 1 tablets) EU/1/04/276/017 (30 mg, 28 × 1 tablets) EU/1/04/276/018 (30 mg, 49 × 1 tablets) EU/1/04/276/019 (30 mg, 56 × 1 tablets) EU/1/04/276/020 (30 mg, 98 × 1 tablets)
Slovenian: EU/1/04/276/016 (30 mg, 14 × 1 tableta) EU/1/04/276/017 (30 mg, 28 × 1 tableta) EU/1/04/276/018 (30 mg, 49 × 1 tableta) EU/1/04/276/019 (30 mg, 56 × 1 tableta) EU/1/04/276/020 (30 mg, 98 × 1 tableta)
English: These medicines may increase the risk of side effects or reduce the effect of ABILIFY; if you get any unusual symptom taking any of these medicines together with ABILIFY you should see your doctor.
Slovenian: Ta zdravila lahko povečajo tveganje za neželene učinke ali zmanjšajo učinek zdravila ABILIFY.
English: Each orodispersible tablet contains 15 mg of aripiprazole.
Slovenian: Ena orodisperzibilna tableta vsebuje 15 mg aripiprazola.
English: Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Slovenian: Tel: +31 (0) 20 85 46 555
English: ABILIFY 10 mg tablets aripiprazole
Slovenian: ABILIFY 10 mg tablete aripiprazol
English: Each orodispersible tablet contains 10 mg of aripiprazole.
Slovenian: Ena orodisperzibilna tableta vsebuje 10 mg aripiprazola.
English: • diabetes mellitus,
Slovenian: • epileptični krči,
English: 3 mg aspartame (E 951) and 0.1125 mg lactose per orodispersible tablet
Slovenian: 3 mg aspartama (E 951) in 0,1125 mg laktoze na orodisperzibilno tableto ABILIFY 30 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 30 mg aripiprazola.
English: In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary endpoint 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 peroralni aripiprazol, (n = 18 ali 13 % ocenljivih bolnikov) kot pri tistih, ki so dobivali peroralni olanzapin (n = 45 ali 33 % ocenljivih bolnikov).
English: In the paediatric bipolar population (10 to 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 28.0 % and 53.3 %,
Slovenian: V pediatrični populaciji z bipolarno motnjo (10 do 17 let), ki so se zdravili do 30 tednov, je bila pogostnost nizke ravni prolaktina v serumu pri deklicah (< 3 ng/ml) 28,0 %, pri dečkih (< 2 ng/ml) pa
English: ABILIFY 5 mg tablets aripiprazole
Slovenian: ABILIFY 5 mg tablete aripiprazol
English: It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Slovenian: Lahko vam škoduje, če imate fenilketonurijo, redko genetsko bolezen,
English: EU/1/04/276/024 (10 mg, 14 × 1 orodispersible tablets) EU/1/04/276/025 (10 mg, 28 × 1 orodispersible tablets) EU/1/04/276/026 (10 mg, 49 × 1 orodispersible tablets)
Slovenian: EU/1/04/276/024 (10 mg, 14 × 1 orodisperzibilna tableta) EU/1/04/276/025 (10 mg, 28 × 1 orodisperzibilna tableta) EU/1/04/276/026 (10 mg, 49 × 1 orodisperzibilna tableta)
English: ABILIFY orodispersible tablets are supplied in perforated unit dose blisters packed in cartons containing 14 × 1, 28 × 1, or 49 × 1 orodispersible tablets.
Slovenian: ABILIFY na voljo so v perforiranih pretisnih omotih v škatlah, ki vsebujejo po 14 × 1, 28 × 1 ali
English: The mean elimination half-lives for aripiprazole are approximately 75 hours in extensive metabolisers of CYP2D6 and approximately 146 hours in poor metabolisers of CYP2D6.
Slovenian: Izločanje Pri osebah, ki dobro presnavljajo s CYP2D6 je srednji razpolovni čas izločanja aripiprazola približno
English: Disodium edetate
Slovenian: PRETISNI OMOTI
English: ABILIFY 10 mg orodispersible tablets aripiprazole
Slovenian: ABILIFY 10 mg orodisperzibilne tablete aripiprazol
English: ABILIFY 15 mg tablets aripiprazole
Slovenian: ABILIFY 15 mg tablete aripiprazol
English: Each tablet contains 15 mg of aripiprazole.
Slovenian: Ena tableta vsebuje 15 mg aripiprazola.
English: ABILIFY orodispersible tablets contain sodium.
Slovenian: Orodisperzibilne tablete ABILIFY vsebujejo natrij.
English: EU/1/04/276/011 (15 mg, 14 × 1 tablets) EU/1/04/276/012 (15 mg, 28 × 1 tablets) EU/1/04/276/013 (15 mg, 49 × 1 tablets) EU/1/04/276/014 (15 mg, 56 × 1 tablets) EU/1/04/276/015 (15 mg, 98 × 1 tablets)
Slovenian: EU/1/04/276/011 (15 mg, 14 × 1 tableta) EU/1/04/276/012 (15 mg, 28 × 1 tableta) EU/1/04/276/013 (15 mg, 49 × 1 tableta) EU/1/04/276/014 (15 mg, 56 × 1 tableta) EU/1/04/276/015 (15 mg, 98 × 1 tableta)
English: Each tablet contains 10 mg of aripiprazole.
Slovenian: Ena tableta vsebuje 10 mg aripiprazola.
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: 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, povprečni 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
English: EU/1/04/276/006 (10 mg, 14 × 1 tablets) EU/1/04/276/007 (10 mg, 28 × 1 tablets) EU/1/04/276/008 (10 mg, 49 × 1 tablets) EU/1/04/276/009 (10 mg, 56 × 1 tablets) EU/1/04/276/010 (10 mg, 98 × 1 tablets)
Slovenian: EU/1/04/276/006 (10 mg, 14 × 1 tableta) EU/1/04/276/007 (10 mg, 28 × 1 tableta) EU/1/04/276/008 (10 mg, 49 × 1 tableta) EU/1/04/276/009 (10 mg, 56 × 1 tableta) EU/1/04/276/010 (10 mg, 98 × 1 tableta)
English: EU/1/04/276/027 (15 mg, 14 × 1 orodispersible tablets) EU/1/04/276/028 (15 mg, 28 × 1 orodispersible tablets) EU/1/04/276/029 (15 mg, 49 × 1 orodispersible tablets)
Slovenian: EU/1/04/276/027 (15 mg, 14 × 1 orodisperzibilna tableta) EU/1/04/276/028 (15 mg, 28 × 1 orodisperzibilna tableta) EU/1/04/276/029 (15 mg, 49 × 1 orodisperzibilna tableta)
English: ABILIFY 15 mg orodispersible tablets aripiprazole
Slovenian: ABILIFY 15 mg orodisperzibilne tablete aripiprazol
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI BESEDILO NA ŠKATLI IN PLASTENKI
English: In a pooled analysis on lipid parameters from placebo controlled clinical trials in adults, aripiprazole has not been shown to induce clinically relevant alterations in levels of total cholesterol, triglycerides, High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL).
Slovenian: Vrednosti lipidov Združena analiza vrednosti lipidov v s placebom nadzorovanih kliničnih preskušanjih pri odraslih ni pokazala, da bi aripiprazol klinično pomembno spremenil vrednosti skupnega holesterola,
English: ABILIFY 10 mg orodispersible tablets 10 mg: Round and pink, marked with "A" over "640" on one side and "10" on the other.
Slovenian: ABILIFY 10 mg orodisperzibilne tablete so okrogle oblike in roza barve, označene z '"A" nad "640"'
English: ABILIFY 1 mg/mL oral solution
Slovenian: ABILIFY 1 mg/ml peroralna raztopina
English: EU/1/04/276/001 (5 mg, 14 × 1 tablets) EU/1/04/276/002 (5 mg, 28 × 1 tablets) EU/1/04/276/003 (5 mg, 49 × 1 tablets) EU/1/04/276/004 (5 mg, 56 × 1 tablets) EU/1/04/276/005 (5 mg, 98 × 1 tablets)
Slovenian: EU/1/04/276/001 (5 mg, 14 × 1 tableta) EU/1/04/276/002 (5 mg, 28 × 1 tableta) EU/1/04/276/003 (5 mg, 49 × 1 tableta) EU/1/04/276/004 (5 mg, 56 × 1 tableta) EU/1/04/276/005 (5 mg, 98 × 1 tableta)
English: ABILIFY 10 mg tablets Red iron oxide (E 172)
Slovenian: ABILIFY 10 mg tablete rdeči železov oksid (E 172)
English: ABILIFY 30 mg orodispersible tablets aripiprazole
Slovenian: ABILIFY 30 mg orodisperzibilne tablete aripiprazol
English: ABILIFY contains parahydroxybenzoates
Slovenian: Zdravilo ABILIFY vsebuje parahidroksibenzoate
English: ABILIFY 30 mg orodispersible tablets Red iron oxide (E 172)
Slovenian: ABILIFY 30 mg orodisperzibilne tablete rdeči železov oksid (E 172)
English: How to store ABILIFY
Slovenian: Shranjevanje zdravila ABILIFY
English: 6 mg aspartame (E 951) and 0.225 mg lactose per orodispersible tablet
Slovenian: 6 mg aspartama (E 951) in 0,225 mg laktoze na orodisperzibilno tableto Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: ABILIFY 10 mg orodispersible tablets Red iron oxide (E 172)
Slovenian: ABILIFY 10 mg orodisperzibilne tablete rdeči železov oksid (E 172)
English: In intravenous reproductive toxicity studies, no new safety concerns were observed at maternal exposures up to 15 (rat) and 29 (rabbit) times human exposure at 30 mg.
Slovenian: Pri izpostavljenosti mater, ki je bila 15krat (podgane) in 29-krat (kunčice) večja od izpostavljenosti človeka pri 30 mg odmerku pri študijah vplivov na sposobnost razmnoževanja po intravenskem dajanju niso ugotovili dodatnih težav glede varnosti.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva rabdomioliza mialgija togost
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 %), 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: 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 30 mg tablets Red iron oxide (E 172)
Slovenian: ABILIFY 30 mg tablete rdeči železov oksid (E 172)
English: Potential for other medicinal products to affect ABILIFY solution for injection
Slovenian: Možnost vpliva drugih zdravil na ABILIFY raztopina za injiciranje Sočasna uporaba lorazepama v obliki raztopine za injiciranje ne vpliva na farmakokinetiko ABILIFY
English: The most commonly reported adverse reactions in placebo-controlled trials were nausea, dizziness and somnolence each occurring in more than 3 % of patients treated with aripiprazole solution for injection.
Slovenian: Vsak se je pojavil pri več kot 3 % bolnikov, ki so se zdravili z aripiprazolom v obliki raztopine za injiciranje.
English: ABILIFY 1 mg/mL oral solution is a clear, colourless to light yellow liquid supplied in bottles with polypropylene child-resistant closure containing 50 mL, 150 mL or 480 mL per bottle.
Slovenian: Na voljo je v plastenkah, ki imajo za otroke varno zaporko iz polipropilena in vsebujejo 50 ml, 150 ml ali 480 ml.
English: ABILIFY 15 mg orodispersible tablets Yellow iron oxide (E 172)
Slovenian: ABILIFY 15 mg orodisperzibilne tablete rumeni železov oksid (E 172)
English: ABILIFY 30 mg orodispersible tablets 30 mg: Round and pink, marked with "A" over "643" on one side and "30" on the other.
Slovenian: ABILIFY 30 mg orodisperzibilne tablete so okrogle oblike in roza barve, označene z '"A" nad "643"'
English: • tiredness,
Slovenian: • driska,
English: • low levels of blood platelets,
Slovenian: • nizke ravni trombocitov,
English: Excipient with known effect 186.54 mg lactose (as monohydrate) per tablet
Slovenian: 186,54 mg laktoze (v obliki monohidrata) na tableto Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: ABILIFY contains the active substance aripiprazole and belong to a group of medicines called antipsychotics.
Slovenian: Raztopina za injiciranje ABILIFY vsebuje učinkovino aripiprazol in spada v skupino zdravil,
English: Water for injections
Slovenian: Raztopina za injiciranje.
English: Peripheral oedema
Slovenian: peroralna raztopina
English: In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain.
Slovenian: Zvečanje telesne mase Klinična preskušanja niso pokazala, da bi aripiprazol povzročil klinično pomembno zvečanje telesne mase.
English: ABILIFY 10 mg orodispersible tablets
Slovenian: ABILIFY 10 mg orodisperzibilne tablete
English: Magnesium stearate
Slovenian: OVOJNINAH NALEPKA VIALE
English: • high blood pressure,
Slovenian: • visok krvni tlak, • izguba zavesti,
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)
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)
English: ABILIFY 30 mg orodispersible tablets
Slovenian: ABILIFY 30 mg orodisperzibilne tablete
English: Tablet coat
Slovenian: • kolcanje.
English: • inflammation of the liver,
Slovenian: • vnetje trebušne slinavke,
English: Aripiprazole was superior to placebo in change from baseline at week 4 and at week 12 on the Y-MRS total score.
Slovenian: Aripiprazol se je v 4. tednu in v 12. tednu pri spremembi skupne ocene po lestvici YMRS od izhodišča izkazal za boljšega od placeba.
English: It is important that you carry on receiving ABILIFY solution for injection for as long as your doctor has told you to.
Slovenian: Odmerek ABILIFY raztopine za injiciranje in trajanje zdravljenja bo določil zdravnik.
English: Methyl parahydroxybenzoate (E 218) Propylene glycol
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi dinatrijev edetat fruktoza glicerol mlečna kislina metilparahidroksibenzoat (E 218) propilenglikol propilparahidroksibenzoat (E 216) natrijev hidroksid saharoza prečiščena voda aroma pomaranče
English: ABILIFY 15 mg orodispersible tablets
Slovenian: ABILIFY 15 mg orodisperzibilne tablete
English: Schizophrenia with oral aripiprazole
Slovenian: Uporaba peroralnega aripiprazola pri shizofreniji
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:
English: • slower heartbeat,
Slovenian: • kolcanje, • suha usta.
English: ABILIFY 15 mg orodispersible tablets are round and yellow, marked with ‘"A" over "641"' on one side and ‘15' on the other.
Slovenian: Okrogle oblike in rumene barve, označene z "A" nad "641" na eni strani in 15 na drugi.