natgillin/translations-raw huggingface dataset:
In a 52-week, placebo-controlled trial, in patients with a current manic or mixed episode of Bipolar I Disorder who achieved sustained remission (Y-MRS and MADRS 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.
V 52-tedenskem, s placebom nadzorovanem preskušanju pri bolnikih s trenutno manično ali mešano epizodo bipolarne motnje I, pri katerih je bilo pri dodatnem zdravljenju z aripiprazolom (v odmerku od 10 mg/dan do 30 mg/dan) poleg litija ali valproata doseženo začasno izboljšanje zdravstvenega stanja, ki je trajalo 12 zaporednih tednov (skupna ocena 12 ali manj po lestvicah Y-MRS in MADRS), se je dodatno zdravljenje z aripiprazolom izkazalo za učinkovitejše od dodatka placeba, s 46 % zmanjšanjem tveganja (razmerje tveganja 0,54) za ponovitev bipolarne motnje in 65 % zmanjšanjem tveganja (razmerje tveganja 0,35) za ponovitev manične epizode, pri preprečevanju ponovitve depresivne epizode pa se dodatno zdravljenje z aripiprazolom ni izkazalo za boljše od placeba.
Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is administered in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as sedation (see section 4.8).
Glede na primarne učinke aripiprazola na osrednji živčni sistem je potrebna previdnost pri uporabi aripiprazola v kombinaciji z alkoholom ali drugimi zdravili, ki delujejo na osrednje živčevje in imajo podobne neželene učinke, npr. sedacijo (glejte poglavje 4.8).
When concomitant administration of ketoconazole with aripiprazole occurs, aripiprazole dose should be reduced to approximately one-half of its prescribed dose.
Če se ketokonazol uporabi sočasno z aripiprazolom, je treba odmerek aripiprazola zmanjšati na približno polovico predpisanega odmerka.
The incidence of hyperprolactinaemia or increased serum prolactin in patients treated with aripiprazole (0.3 %) was similar to that of placebo (0.2 %).
Pojavnost hiperprolaktinemije ali zvišane ravni prolaktina v serumu pri bolnikih, zdravljenih z aripiprazolom (0,3 %), je bila podobna tisti pri skupini s placebom (0,2 %).
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 (2-15 mg/day) and one fixed-dose (5, 10, or 15 mg/day)] and in one 52-week open-label trial.
Razdražljivost, povezana z avtistično motnjo, pri pediatričnih bolnikih (glejte poglavje 4.2) 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 do 15 mg/dan), v drugem pa z uporabo fiksnega odmerka (5, 10 ali 15 mg/dan)] in v enem 52-tedenskem odprtem preskušanju.
Aripiprazole doses ranging from 0.5 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.
S pozitronsko emisijsko tomografijo so pokazali, da je 2-tedenska uporaba odmerkov od 0,5 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.
However, in one of these trials, a fixed-dose trial, there was a significant dose response relationship for cerebrovascular adverse reactions in patients treated with aripiprazole (see section 4.8).
Toda v enem od teh preskušanj (preskušanje s fiksnim odmerkom) je pri bolnikih, ki so dobivali aripiprazol, za cerebrovaskularne neželene učinke obstajala značilna povezanost odmerka in odziva (glejte poglavje 4.8).
When either valproate or lithium was administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations and therefore no dose adjustment is necessary when either valproate or lithium is administered with aripiprazole.
Med sočasno uporabo aripiprazola z litijem ali valproatom se koncentracija aripiprazola ni klinično pomembno spremenila, zato prilagoditev odmerka pri sočasni uporabi aripiprazola z litijem ali valproatom ni potrebna.
Manic episodes in Bipolar I Disorder: the recommended starting dose for aripiprazole is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Manične epizode pri bipolarni motnji I: priporočeni začetni odmerek aripiprazola 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).
An elevated risk of acute dystonia is observed in males and younger age groups.
O večjem tveganju za pojav akutne distonije so poročali pri bolnikih moškega spola in bolnikih mlajših starostnih skupin.
When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should then be reduced to the recommended dose (see section 4.5).
Če se induktor CYP3A4 iz kombinacije opusti, je treba odmerek aripiprazola nato zmanjšati na priporočeni odmerek (glejte poglavje 4.5).
• decreased number of or difficulty making bowel movements,
• zmanjšano ali oteženo odvajanje blata,
Luxembourg/Luxemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
In paediatric clinical trials of aripiprazole akathisia and Parkinsonism were observed.
Pri kliničnih študijah aripiprazola pri pediatričnih bolnikih so opazili pojav akatizije in parkinsonizma.
According to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers (see section 4.5).
Kajenje Glede na presnovno pot aripiprazola odmerka pri kadilcih ni treba prilagajati (glejte poglavje 4.5).
PA/Alu/PVC- Aluminium foil perforated blisters (alu-alu blister) in cartons of 14, 28, 56 and 98 tablets and 28 x 1 tablets (unit dose)
PA/Alu/PVC-aluminijski perforirani pretisni omoti (alu-alu pretisni omot) v škatlah po 14, 28, 56, in 98 tablet in 28 x 1 tableto.
• other anti-depressants (such as venlafaxine and tryptophan) used in major depression
• druge antidepresive (kot sta venlafaksin in triptofan) uporabljamo za veliko depresijo,
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.
Predklinični podatki 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.
Aripiprazole 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).
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba aripiprazola pri bolnikih s shizofrenijo, mlajših od 15 let, ni priporočljiva (glejte poglavji 4.8 in 5.1).
Mean changes in body weight in adolescents with Bipolar I Disorder at 12 and 30 weeks for aripiprazole were 2.4 kg and 5.8 kg, and for placebo 0.2 kg and 2.3 kg, respectively.
Povprečne spremembe telesne mase pri mladostnikih z bipolarno motnjo I so po 12 tednih uporabe aripiprazola znašale 2,4 kg in po 30 tednih 5,8 kg.
In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13-17 years), presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
V 6-tedenskem s placebom nadzorovanem preskušanju, ki je vključevalo 302 mladostnika (13-17 let) s shizofrenijo s pozitivnimi in negativnimi simptomi, je bil aripiprazol povezan s statistično značilno večjim izboljšanjem psihotičnih simptomov v primerjavi s placebom.
Ketoconazole and other CYP3A4 inhibitors
Ketokonazol in drugi močni zaviralci CYP3A4
Upon discontinuation of strong CYP3A4 inducers, the dosage of aripiprazole should be reduced to the recommended dose.
Po prenehanju uporabe močnih induktorjev CYP3A4 je treba odmerjanje aripiprazola zmanjšati na priporočeni odmerek.
• in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.
• krvne preiskave: nihanje ravni sladkorja v krvi, zvišana raven glikoziliranega hemoglobina,
When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased (see section 4.5).
Če se zaviralec CYP3A4 ali CYP2D6 iz kombinacije opusti, je treba odmerek aripiprazola nato zvečati (glejte poglavje 4.5).
Aripiprazole is the predominant medicinal product moiety in systemic circulation.
Aripiprazol je glavna oblika zdravila v sistemskem obtoku.
Mylan S.A.S, 117, Allée des Parcs, 69800 Saint-Priest, France
Mylan S.A.S, 117, Allée des Parcs,
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema levkopenija nevtropenija trombocitopenija
• tricyclic's (such as clomipramine and amitriptyline) used for depressive illness
• triciklične antidepresive (kot sta klomipramin in amitriptilin) uporabljamo za depresijo,
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.
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 %.
In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult patients, presenting with positive or negative symptoms, 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 aripiprazol dosegel statistično značilno večje izboljšanje psihotičnih simptomov kot placebo.
Mean weight gain in the 30 weeks treatment-interval was 2.9 kg as compared to 0.98 kg in patients treated with placebo.
Po 30 tednih zdravljenja je bilo povprečno povečanje telesne mase 2,9 kg, pri bolnikih, ki so prejemali placebo pa 0,98 kg.
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Additional side effects in children and adolescents 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).
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 (pojavijo se lahko 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 (pojavijo se lahko pri več kot 1 od 100 bolnikov).
• heart attack,
• srčni infarkt,
Extrapyramidal symptoms (EPS) Schizophrenia: in a long term 52-week controlled trial, aripiprazoletreated patients had an overall-lower incidence (25.8 %) of EPS including Parkinsonism, akathisia, dystonia and dyskinesia compared with those treated with haloperidol (57.3 %).
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 %).
The AUC and Cmax of dehydroaripiprazole increased by 77 % and 43 %, respectively.
AUC dehidroaripiprazola se je zvečala za 77 %, njegova Cmax pa za 43 %.
There is no effect of a high fat meal on the pharmacokinetics of aripiprazole.
Zelo mastni obroki ne vplivajo na farmakokinetiko aripiprazola.
Česká republika Mylan Pharmaceuticals.s.r.o.
Mylan Pharmaceuticals.s.r.o.
Owing to the greater sensitivity of this population, a lower starting dose should be considered when clinical factors warrant (see section 4.4).
Če klinični dejavniki zahtevajo, je treba zaradi večje občutljivosti te skupine razmisliti o manjšem začetnem odmerku (glejte poglavje 4.4).
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, HDL and LDL.
Združena analiza vrednosti lipidov v s placebom nadzorovanih kliničnih preskušanjih pri odraslih ni pokazala, da bi aripiprazol klinično pomembno spremenil vrednosti skupnega holesterola, trigliceridov, lipoproteinov velike gostote (HDL) in lipoproteinov majhne gostote (LDL).
In repeat-dose studies in juvenile rats and dogs, the toxicity profile of aripiprazole was comparable to that observed in adult animals, and there was no evidence of neurotoxicity or adverse reactions on development.
Pri študijah s ponavljajočimi se odmerki pri mladih podganah in psih je bil profil toksičnosti aripiprazola primerljiv s profilom toksičnosti pri odraslih živalih.
Aripiprazole Mylan Pharma is for oral use.
Zdravilo Aripiprazol Mylan Pharma je namenjeno za peroralno uporabo.
Cardiovascular disorders
Srčnožilne bolezni
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.
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.
In clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
V kliničnih preskušanjih, ki so trajala eno leto ali manj, so med zdravljenjem z aripiprazolom občasno poročali o diskineziji, nastali med zdravljenjem.
Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
Tudi pri aripiprazolu se lahko pojavijo preobčutljivostne reakcije v obliki simptomov alergije (glejte poglavje 4.8).
In schizophrenia patients the incidence of akathisia was 6.2 % with aripiprazole and 3.0 % with placebo.
Pri bolnikih s shizofrenijo je bila pojavnost akatizije pri uporabi aripiprazola 6,2 %, pri uporabi placeba pa 3,0 %.
In a 6-week, placebo-controlled trial involving patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, who were partially non-responsive to lithium or valproate monotherapy for 2 weeks at therapeutic serum levels, the addition of aripiprazole as adjunctive therapy resulted in superior efficacy in reduction of manic symptoms than lithium or valproate monotherapy.
V 6-tedenskem s placebom nadzorovanem preskušanju pri bolnikih z manično ali mešano epizodo bipolarne motnje I s psihotičnimi simptomi ali brez njih, ki so bili po 2 tednih pri terapevtskih koncentracijah v serumu deloma neodzivni na samostojno zdravljenje z litijem ali valproatom, se je po uvedbi aripiprazola kot dodatnega zdravila povečala učinkovitost pri zmanjšanju maničnih simptomov v primerjavi s samostojnim zdravljenjem z litijem ali valproatom.
• uncontrollable twitching, jerking or writhing movements, restless legs,
• nenadzorovano trzanje ali sunkoviti gibi, nemirne noge,
Weight gain is commonly seen in schizophrenic and bipolar mania patients due to co-morbidities, use of antipsychotics known to cause weight gain, poorly managed life-style, and might lead to severe complications.
Pri bolnikih s shizofrenijo in bipolarno manijo je povečanje telesne mase pogosto, in sicer zaradi komorbidnih stanj, uporabe antipsihotikov, za katere je znano, da povzročajo povečanje mase, in zaradi neurejenega življenjskega sloga.
Aripiprazole did not impair fertility in reproductive toxicity studies.
V raziskavah reprodukcijskih toksičnih učinkov aripiprazol ni prizadel plodnosti.
Aripiprazole Mylan Pharma tablets contain maltose.
Tablete zdravila Aripiprazol Mylan Pharma vsebujejo maltozo.
Blood glucose increased Glycosylated haemoglobin increased Blood glucose fluctuation Increased creatine phosphokinase
Preiskave zvišana vrednost glukoze v krvi zvišana vrednost glikoziliranega hemoglobina nihanje vrednosti glukoze v krvi zvišana aktivnost keratinfosfokinaze
Younger patients are at increased risk of experiencing adverse events associated with aripiprazole.
Pri mlajših bolnikih je tveganje za pojav neželenih učinkov aripiprazola večje.
• not enough sodium in the blood,
• nezadostna koncentracija natrija v krvi,
Before treatment with Aripiprazole Mylan Pharma tell your doctor if you suffer from
Pred začetkom zdravljenja z zdravilom Aripiprazol Mylan Pharma morate obvestiti zdravnika, če:
What Aripiprazole Mylan Pharma is and what it is used for
Kaj je zdravilo Aripiprazol Mylan Pharma in za kaj ga uporabljamo
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.
Pri osebah, ki dobro presnavljajo s CYP2D6 je srednji razpolovni čas izločanja aripiprazola približno 75 ur, pri osebah, ki slabo presnavljajo pa približno 146 ur.
Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking aripiprazole.
Patološko hazardiranje in druge motnje nadzora impulzov Pri bolnikih se lahko poveča impulzivnost, zlasti želja po igrah na srečo, med jemanjem aripiprazola pa teh niso več sposobni nadzorovati.
The incidence of hypoprolactinaemia or decreased serum prolactin in patients treated with aripiprazole was 0.4 %, compared with 0.02 % for patients treated with placebo.
Pojavnost hipoprolaktinemije ali znižane ravni prolaktina v serumu pri bolnikih, zdravljenih z aripiprazolom, je bila 0,4 % v primerjavi s skupino s placebom (0,02 %).
Warnings and precautions Talk to your doctor before taking Aripiprazole Mylan Pharma
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Aripiprazol Mylan Pharma se posvetujte z zdravnikom.
In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
V kliničnih preskušanjih so med zdravljenjem z aripiprazolom poročali o redkih primerih MNS-a.
The AUC and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively.
AUC aktivnega presnovka dehidroaripiprazola se je zmanjšala za 32 %, njegova Cmax pa za 47 %.
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose for aripiprazole is 10 mg/day administered on a once-a-day schedule without regard to meals.
Manične epizode pri bipolarni motnji I pri mladostnikih, starih 13 let in več: priporočeni odmerek aripiprazola je 10 mg enkrat na dan ne glede na obrok hrane.
In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1 % with aripiprazole and 3.2 % with placebo.
V s placebom nadzorovanih preskušanjih je bila pojavnost akatizije pri bolnikih z bipolarno motnjo pri uporabi aripiprazola 12,1 %, pri uporabi placeba pa 3,2 %.
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 0,57 (statistično nepomembna razlika).
Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Znaki in simptomi serotoninskega sindroma se lahko pojavijo še posebej pri sočasni uporabi z drugimi serotoninergičnimi zdravili, kot so selektivni zaviralci privzema serotonina/selektivni zaviralci privzema serotonina in noradrenalina ali z zdravili, ki zvišujejo koncentracijo aripiprazola (glejte poglavje 4.8).
Manic episodes in Bipolar I Disorder in children and adolescents Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents (10-17 years), who met DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a Y-MRS score ≥ 20 at baseline.
Manične epizode pri bipolarni motnji I pri otrocih in mladostnikih Uporabo aripiprazola so raziskovali v 30-tedenskem s placebom nadzorovanem preskušanju, ki je vključevalo 296 otrok in mladostnikov (10-17 let), ki so ustrezali kriterijem DSM-IV za bipolarno motnjo I z maničnimi ali mešanimi epizodami s psihotičnimi lastnostmi ali brez njih, in so imeli v izhodišču oceno ≥ 20 po lestvici Y-MRS. Izmed bolnikov, ki so bili vključeni v primarno analizo učinkovitosti, je imelo 139 bolnikov sočasno tudi diagnozo motnje pomanjkanja pozornosti (ADHD‘Attention deficit hyperactivity disorder').
In another 12-week trial, the incidence of EPS was 26.6 % for patients treated with aripiprazole and 17.6 % for those treated with lithium.
V drugem 12-tedenskem preskušanju je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 26,6 %, pri bolnikih, ki so se zdravili z litijem pa 17,6 %.
A single-dose study in subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, and C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole and dehydro-aripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which is insufficient to draw conclusions on their metabolic capacity.
Raziskava z enim samim odmerkom pri preiskovancih z različno stopnjo jetrne ciroze (razredi A, B in C po Child-Pughu) ni pokazala pomembnega učinka okvare jeter na farmakokinetiko aripiprazola in dehidroaripiprazola.
Following a single oral dose of [14C]-labelled aripiprazole, approximately 27% of the administered radioactivity was recovered in the urine and approximately 60 % in the faeces.
Po enem samem peroralnem odmerku aripiprazola, označenega s [14C], se je približno 27 %
Talk to your doctor about the best way to feed your baby if you are taking this medicine.
Če prejemate to zdravilo, se z zdravnikom posvetujte o najprimernejših načinih hranjenja otroka.
Population pharmacokinetic evaluation showed no evidence of race-related differences on the pharmacokinetics of aripiprazole.
Populacijska farmakokinetična analiza ni pokazala klinično pomembnih učinkov rase na farmakokinetiko aripiprazola.
• nervousness,
• živčnost,
Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Pri uporabi antipsihotikov so poročali o primerih venske trombembolije (VTE).
However, the estimation of the HR for the younger (13-14 years) group was not precise, reflecting the smaller number of subjects in that group (aripiprazole, n = 29; placebo, n = 12), and the confidence interval for this estimation (ranging from 0.151 to 1.628) did not allow conclusions to be drawn on the presence of a treatment effect.
Vendar pa izračun razmerja tveganja za mlajšo skupino (13 do 14 let) ni bil natančen zaradi manjšega števila bolnikov v tej skupini (aripiprazol, n = 29; placebo, n = 12).