natgillin/translations-raw huggingface dataset:
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.
(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).
The oral solution should not be diluted with other liquids or mixed with any food prior to administration.
Peroralne raztopine pred uporabo ni dovoljeno mešati z drugimi tekočinami ali s hrano.
ABILIFY orodispersible tablets contain aspartame.
Orodisperzibilne tablete ABILIFY vsebujejo aspartam.
- binge eating (eating large amounts of food in a short time period) or compulsive eating
- 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.
ABILIFY 15 mg tablets are round and yellow, marked with ‘A-009' and ‘15' on one side.
Tablete ABILIFY 15 mg so okrogle in rumene, označene z 'A-009' in '15' na eni strani.
Population pharmacokinetic evaluation showed no evidence of race-related differences on the pharmacokinetics of aripiprazole.
Rasa Populacijska farmakokinetična analiza ni pokazala klinično pomembnih učinkov rase na farmakokinetiko aripiprazola.
Do not stop your treatment just because you feel better.
Čeprav se počutite bolje, zdravljenja ne smete prekiniti.
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.
cerebrovaskularno boleznijo ali stanji, ki ustvarjajo nagnjenost k hipotenziji (dehidracija, hipovolemija in zdravljenje z antihipertenzivi) ali hipertenziji, vključno s pospešeno in maligno hipertenzijo.
Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1, 56 × 1, 98 × 1 tablets.
Aluminijski perforirani pretisni omoti za enkratni odmerek v škatlah po 14 × 1, 28 × 1, 49 × 1, 56 × 1, 98 × 1 tablet.
ABILIFY 30 mg orodispersible tablets: This medicine contains 6 mg aspartame in each tablet.
ABILIFY 30 mg orodisperzibilne tablete: To zdravilo vsebuje 6 mg aspartama v tableti.
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.
Shizofrenija pri mladostnikih, starih 15 let in več: priporočeni odmerek zdravila ABILIFY je 10 mg enkrat na dan ne glede na obroke hrane.
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.
Ob ekvivalentnih odmerkih je bila največja koncentracija aripiprazola v plazmi (Cmax) pri uporabi raztopine nekoliko večja,
ABILIFY 15 mg orodispersible tablets 15 mg: Round and yellow, marked with "A" over "641" on one side and "15" on the other.
ABILIFY 15 mg orodisperzibilne tablete so okrogle oblike in rumene barve, označene z '"A" nad "641"' na eni strani in '15' na drugi.
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.
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.
However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.
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.
In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107 %, while Cmax was unchanged.
CYP2D6 (kinidin) zvečal AUC aripiprazola za 107 %, Cmax pa se ni spremenila.
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.
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 %.
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.
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 %.
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.
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.
ABILIFY 15 mg orodispersible tablets: This medicine contains 3 mg aspartame in each tablet.
ABILIFY 15 mg orodisperzibilne tablete: To zdravilo vsebuje 3 mg aspartama v tableti.
Rectangular and blue, engraved with "A-007" and "5" on one side.
Pravokotne oblike in modre barve z vrezano oznako “A-007” in “5” na eni strani.
Only take other medicines while you are on ABILIFY if your doctor tells you that you can.
Med uporabo zdravila ABILIFY smete druga zdravila uporabljati le, če vam to dovoli zdravnik.
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
Kaj je zdravilo ABILIFY in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ABILIFY Kako uporabljati zdravilo ABILIFY
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).
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.
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)
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)
Weight gain has been reported post-marketing among patients prescribed oral aripiprazole.
V obdobju po začetku trženja aripiprazola so pri bolnikih, ki so jim ga predpisali, poročali o povečanju telesne mase.
Do not use this medicine after the expiry date which is stated on the carton and on the vial after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake “Upor.
ABILIFY 10 mg orodispersible tablets: This medicine contains 2 mg aspartame in each tablet.
ABILIFY 10 mg orodisperzibilne tablete: To zdravilo vsebuje 2 mg aspartama v tableti.
Aripiprazole demonstrated statistically superior efficacy compared to placebo on the Aberrant Behaviour Checklist Irritability subscale.
Checklist Irritability subscale”) se je izkazalo, da je aripiprazol statistično učinkovitejši od placeba, vendar pa pomen te ugotovitve za klinično uporabo ostaja neznan.
ABILIFY 1 mg/mL oral solution aripiprazole
ABILIFY 1 mg/ml peroralna raztopina aripiprazol
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).
Zdravilo ABILIFY je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I pri mladostnikih, starih 13 let in več.
Not known increased
Neznana pogostnost
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.
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.
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 %),
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
ABILIFY 7.5 mg/mL solution for injection aripiprazole
ABILIFY 7,5 mg/ml raztopina za injiciranje aripiprazol
• 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.
metilparahidroksibenzoat (E 218), propilenglikol, propilparahidroksibenzoat (E 216), natrijev hidroksid, saharoza, prečiščena voda in aroma pomaranče.
Photosensitivity reaction Alopecia
Bolezni kože in podkožja izpuščaj fotosenzibilnostna reakcija alopecija
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.
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.
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.
[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.
In clinical trials of treatment with oral aripiprazole, the incidence of QT prolongation was comparable to placebo.
Incidenca podaljšanja intervala QT je bila v kliničnih preskušanjih zdravljenj s peroralnim aripiprazolom primerljiva s placebom.
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
• imate srčnožilne bolezni (bolezni srca in ožilja), srčnožilne bolezni v družini, možgansko kap ali
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).
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).
ABILIFY 5 mg tablets Each tablet contains 5 mg of aripiprazole.
ABILIFY 5 mg tablete Ena tableta vsebuje 5 mg aripiprazola.
Aripiprazole administered intramuscularly as a single-dose to healthy subjects is well absorbed and has an absolute bioavailability of 100 %.
Po intramuskularni aplikaciji enega samega odmerka aripiprazola zdravim osebam je bila absorpcijadobra.
Rectangular and pink, engraved with "A-008" and "10" on one side.
Pravokotne oblike in roza barve z vrezano oznako “A-008” in “10” na eni strani.
OUTER CARTON AND BOTTLE LABEL
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
Pregnancy, puerperium and perinatal conditions
Motnje reprodukcije in dojk priapizem
ABILIFY 10 mg tablets are rectangular and pink, marked with ‘A-008' and ‘10' on one side.
Tablete ABILIFY 10 mg so pravokotne in roza, označene z 'A-008' in '10' na eni strani.
Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1 tablets.
Aluminijski perforirani pretisni omoti za enkratni odmerek v škatlah po 14 × 1, 28 × 1, 49 × 1 tableta.
Overall, 1.3 % of aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of placebo-treated patients in these trials.
1,3 % bolnikov, zdravljenih z aripiprazolom, in pri 0,6 % bolnikov, ki so dobivali placebo.
ABILIFY 10 mg orodispersible tablets Each orodispersible tablet contains 10 mg of aripiprazole.
ABILIFY 10 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 10 mg aripiprazola.
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.
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 %.
No cases of overdose associated with adverse reactions were reported in clinical studies with ABILIFY solution for injection.
V kliničnih študijah z zdravilom ABILIFY raztopina za injiciranje niso poročali o primerih prevelikega odmerjanja, povezanimi z neželenimi učinki.
ABILIFY orodispersible tablets contain lactose.
Orodisperzibilne tablete ABILIFY vsebujejo laktozo.
Each mL contains 1 mg of aripiprazole.
En mililiter vsebuje 1 mg aripiprazola.
ABILIFY 15 mg orodispersible tablets Each orodispersible tablet contains 15 mg of aripiprazole.
ABILIFY 15 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 15 mg aripiprazola.
The oral solution contains sodium.
Peroralna raztopina vsebuje natrij.
Excipient with known effect 62.18 mg lactose (as monohydrate) per tablet
62,18 mg laktoze (v obliki monohidrata) na tableto ABILIFY 15 mg tablete
ABILIFY solution for injection contains sodium.
Raztopina za injiciranje ABILIFY vsebuje natrij.
Rhabdomyolysis Myalgia
Peroralna raztopina
Package leaflet: Information for the user ABILIFY 7.5 mg/mL solution for injection aripiprazole
Navodilo za uporabo ABILIFY 7,5 mg/ml raztopina za injiciranje aripiprazol
Package leaflet: Information for the user ABILIFY 1 mg/mL oral solution aripiprazole
Navodilo za uporabo ABILIFY 1 mg/ml peroralna raztopina aripiprazol
Aripiprazole is well absorbed when administered orally as the solution.
Peroralno uporabljeni aripiprazol v obliki raztopine se dobro absorbira.
ABILIFY contains lactose
Zdravilo ABILIFY vsebuje laktozo
Solution for injection Clear, colourless, aqueous solution.
Bistra, brezbarvna, vodna raztopina.
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:
Zdravila, ki povečajo raven serotonina, navadno uporabljamo za bolezni, vključno z depresijo,
Aspiration pneumonia Laryngospasm Oropharyngeal spasm
Bolezni dihal, prsnega koša in mediastinalnega prostora kolcanje aspiracijska pljučnica laringospazem orofaringealni spazem
Mouth dry
Okvara jeter
Each orodispersible tablet contains 30 mg of aripiprazole.
Ena orodisperzibilna tableta vsebuje 30 mg aripiprazola.
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).
Razmerje ogroženosti za ponovitev v 16 tednih (aripiprazol/placebo) je bilo
Each tablet contains 30 mg of aripiprazole.
Ena tableta vsebuje 30 mg aripiprazola.
Each tablet contains 5 mg of aripiprazole.
Ena tableta vsebuje 5 mg aripiprazola.
The recommended dose for adults is 15 mL solution (corresponding to 15 mg aripiprazole) once a day.
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)
Hepatic failure Hepatitis Jaundice
žolčnika in žolčevodov odpoved jeter hepatitis zlatenica
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)
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)
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.
Ta zdravila lahko povečajo tveganje za neželene učinke ali zmanjšajo učinek zdravila ABILIFY.
Each orodispersible tablet contains 15 mg of aripiprazole.
Ena orodisperzibilna tableta vsebuje 15 mg aripiprazola.
Each orodispersible tablet contains 10 mg of aripiprazole.
Ena orodisperzibilna tableta vsebuje 10 mg aripiprazola.
• diabetes mellitus,
• epileptični krči,
3 mg aspartame (E 951) and 0.1125 mg lactose per orodispersible tablet
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.
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).
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).
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 %,
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
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.
Lahko vam škoduje, če imate fenilketonurijo, redko genetsko bolezen,
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)
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)
ABILIFY orodispersible tablets are supplied in perforated unit dose blisters packed in cartons containing 14 × 1, 28 × 1, or 49 × 1 orodispersible tablets.
ABILIFY na voljo so v perforiranih pretisnih omotih v škatlah, ki vsebujejo po 14 × 1, 28 × 1 ali
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.
Izločanje Pri osebah, ki dobro presnavljajo s CYP2D6 je srednji razpolovni čas izločanja aripiprazola približno
Disodium edetate
PRETISNI OMOTI
ABILIFY 10 mg orodispersible tablets aripiprazole
ABILIFY 10 mg orodisperzibilne tablete aripiprazol
Each tablet contains 15 mg of aripiprazole.
Ena tableta vsebuje 15 mg aripiprazola.
ABILIFY orodispersible tablets contain sodium.
Orodisperzibilne tablete ABILIFY vsebujejo natrij.
Each tablet contains 10 mg of aripiprazole.
Ena tableta vsebuje 10 mg aripiprazola.
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.
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
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)
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)
ABILIFY 15 mg orodispersible tablets aripiprazole
ABILIFY 15 mg orodisperzibilne tablete aripiprazol
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI BESEDILO NA ŠKATLI IN PLASTENKI
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).
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,
ABILIFY 10 mg orodispersible tablets 10 mg: Round and pink, marked with "A" over "640" on one side and "10" on the other.
ABILIFY 10 mg orodisperzibilne tablete so okrogle oblike in roza barve, označene z '"A" nad "640"'
ABILIFY 1 mg/mL oral solution
ABILIFY 1 mg/ml peroralna raztopina
ABILIFY 10 mg tablets Red iron oxide (E 172)
ABILIFY 10 mg tablete rdeči železov oksid (E 172)
ABILIFY 30 mg orodispersible tablets aripiprazole
ABILIFY 30 mg orodisperzibilne tablete aripiprazol
ABILIFY contains parahydroxybenzoates
Zdravilo ABILIFY vsebuje parahidroksibenzoate
ABILIFY 30 mg orodispersible tablets Red iron oxide (E 172)
ABILIFY 30 mg orodisperzibilne tablete rdeči železov oksid (E 172)