natgillin/translations-raw huggingface dataset:
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.
Tikovi povezani s Touretteovim poremećajem u pedijatrijskih bolesnika (vidjeti dio 4.2) Djelotvornost aripiprazola bila je ispitana u pedijatrijskih ispitanika s Touretteovim sindromom (aripiprazol: n = 99, placebo: n = 44) u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 8 tjedana u kojem su terapijske skupine primale fiksne doze na temelju tjelesne težine u rasponu od 5 mg na dan do 20 mg na dan, uz početnu dozu od 2 mg.
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.
Pojava hipoprolaktinemije ili smanjenog prolaktina u serumu u bolesnika liječenih aripiprazolom je 0,4 % u usporedbi s 0,02 % za bolesnike liječene placebom.
Additionally, aripiprazole and dehydroaripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro.
Osim toga, aripiprazol i dehidro-aripiprazol in vitro nisu pokazali potencijal da mijenjaju metabolizam posredovan enzimom CYP1A2 pa stoga nije vjerojatno da će aripiprazol prouzročiti klinički važne interakcije s drugim lijekovima koji se metaboliziraju putem navedenih enzima.
It has been proposed that aripiprazole's efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism of serotonin 5-HT2A receptors.
I jest da je ono posredovano kombinacijom djelomičnog agonizma s dopaminskim D2 i serotoninskim 5HT1A receptorima i antagonizma sa serotoninskim 5HT2A receptorima.
Hyperglycaemia and diabetes mellitus
Hiperglikemija i šećerna bolest
In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1 % with aripiprazole and 3.2 % with placebo.
U placebom kontroliranim ispitivanjima, incidencija akatizije u bipolarnih bolesnika bila je 12,1 % uz aripiprazol i 3,2 % uz placebo.
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.
U tri kratkotrajna (4-6 tjedana), placebom kontrolirana ispitivanja koja su uključila 1228 odraslih bolesnika s pozitivnim ili negativnim simptomima shizofrenije, aripiprazol je bio povezan sa statistički značajno većim poboljšanjima psihotičnih simptoma u usporedbi s placebom.
In clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
U kliničkim ispitivanjima u trajanju od jedne godine ili kraće, diskinezija povezana s liječenjem je manje često prijavljena nuspojava tijekom liječenja aripiprazolom.
Patients were 7 - 17 years of age and presented an average score of 30 on Total Tic Score on the Yale Global Tic Severity Scale (TTS-YGTSS) at baseline.
Bolesnici su bili u dobi od 7 do 17 godina i imali su prosječno 30 bodova na početku ispitivanja za ukupni zbroj tikova na Yaleovoj općoj ljestvici težine tikova (engl.
In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain.
U kliničkim se ispitivanjima nije pokazalo da aripiprazol inducira klinički značajno povećanje tjelesne težine.
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.
I i ADHD-a, dostupno je vrlo malo podataka o sigurnosti istodobne primjene aripiprazola i stimulansa; stoga je potreban izniman oprez kod istodobne primjene tih dvaju lijekova.
Four mood stabilizer subgroups were assessed in the randomised phase: aripiprazole + lithium; aripiprazole + valproate; placebo + lithium; placebo + valproate.
+ litij, aripiprazol + valproat, placebo + litij, placebo + valproat.
Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reductions should therefore be applied.
Slični učinci mogu se očekivati i od drugih jakih inhibitora enzima CYP2D6, kao što su fluoksetin i paroksetin pa se stoga moraju provesti slična smanjenja doze.
Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13-17 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): Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10).
Shizofrenija u adolescenata u dobi od 15 godina i starijih U kratkotrajnom placebom kontroliranom kliničkom ispitivanju u kojem su sudjelovala 302 adolescenta (13-17 godina) sa shizofrenijom, učestalost i vrsta nuspojava bile su slične onima u odraslih, osim što su sljedeće nuspojave bile prijavljene češće u adolescenata koji su primali aripiprazol nego u odraslih koji su primali aripiprazol (i češće nego uz placebo): Somnolencija/sedacija i ekstrapiramidni poremećaji bili su prijavljeni vrlo često (≥ 1/10), dok su često bili prijavljeni suha usta, pojačan apetit i ortostatska hipotenzija (≥ 1/100, < 1/10).Sigurnosni profil u
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.
U objedinjenim je ispitivanjima incidencija niske razine prolaktina u serumu u djevojčica (< 3 ng/ml) liječenih aripiprazolom iznosila 27/46 (58,7 %), a u dječaka (< 2 ng/ml) 258/298 (86,6 %).
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava leukopenija neutropenija trombocitopenija
Aripiprazole Mylan Pharma tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Aripirazol Mylan Pharma tablete sadrže manje od 1 mmol natrija (23 mg) po tableti, tj. zanemarive količine natrija.
Urinary incontinence Urinary retention
Poremećaji bubrega i mokraćnog sustava urinarna inkontinencija urinarna retencija
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 u bipolarnom poremećaju tipa I: u kontroliranom ispitivanju u trajanju od 12 tjedana, incidencija EPS-a bila je 23,5 % u bolesnika liječenih aripiprazolom i 53,3 % u bolesnika liječenih haloperidolom.
If signs and symptoms of tardive dyskinesia appear in a patient on aripiprazole, dose reduction or discontinuation should be considered (see section 4.8).
Ako se u bolesnika koji uzima aripiprazolpojave znakovi i simptomi tardivne diskinezije, mora se razmotriti smanjenje doze ili prekid terapije (vidjeti dio 4.8).
The mean weight gain over the stabilisation phase (up to 26 weeks) on aripiprazole was 3.2 kg, and a further mean increase of 2.2 kg for aripiprazole as compared to 0.6 kg for placebo was observed in the second phase (16 weeks) of the trial.
Srednje povećanje tjelesne težine bolesnika tijekom faze stabilizacije (najviše 26 tjedana) u ispitanika na aripiprazolu iznosilo je 3,2 kg, a u drugoj fazi ispitivanja (16 tjedana) zabilježeno je dodatno srednje povećanje od 2,2 kg u usporedbi s 0,6 kg u bolesnika koji su primali placebo.
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.
Nakon prekida primjene inhibitora CYP2D6 ili CYP3A4, dozu aripiprazola mora se povisiti na razinu kakva je bila prije započinjanja istodobne terapije tim lijekovima.
In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56-99 years) of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, patients treated with aripiprazole were at increased risk of death compared to placebo.
82,4 godine; raspon: 56-99 godina) s psihozom koja je bila povezana s Alzheimerovom bolešću, bolesnici liječeni aripiprazolom imali su povišen rizik od smrti u odnosu na bolesnike koji su primali placebo.
There is no effect of a high fat meal on the pharmacokinetics of aripiprazole.
Obrok bogat mastima nema učinka na farmakokinetiku aripiprazola.
• if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati lijek Aripiprazole Mylan Pharma ako ste alergični na aripiprazol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
Overall, 1.3 % of aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of placebo-treated patients in these trials.
Cerebrovaskularne nuspojave bile su prijavljene u ukupno 1,3 % bolesnika liječenih aripiprazolom u usporedbi s 0,6 % bolesnika koji su u tim ispitivanjima primali placebo.
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.
U šestotjednom, placebom kontroliranom ispitivanju u koje su bila uključena 302 adolescentna bolesnika sa shizofrenijom (u dobi od 13 do 17 godina) i prisutnim pozitivnim ili negativnim simptomima, aripiprazol je bio povezan sa statistički značajno većim poboljšanjem psihotičnih simptoma u usporedbi s placebom.
Pathological gambling and other impulse control disorders Pathological gambling, hypersexuality, compulsive shopping and binge or compulsive eating can occur in patients treated with aripiprazole (see section 4.4).
U bolesnika liječenih aripiprazolom mogu se razviti patološko kockanje, hiperseksualnost, kompulzivno kupovanje i kompulzivno prejedanje (vidjeti dio 4.4)
Aripiprazole is metabolised by multiple pathways involving the CYP2D6 and CYP3A4 enzymes but not CYP1A enzymes.
Aripiprazol se metabolizira kroz više putova, uključujući enzime CYP2D6 i CYP3A4, ali ne i enzime CYP1A pa stoga nije potrebno prilagoditi dozu u pušača.
Upon discontinuation of strong CYP3A4 inducers, the dosage of aripiprazole should be reduced to the recommended dose.
Nakon prekida primjene jakih induktora CYP3A4, doza aripiprazola mora se smanjiti na preporučenu dozu.
Aripiprazole Mylan Pharma 5 mg tablets Aripiprazole Mylan Pharma 10 mg tablets Aripiprazole Mylan Pharma 15 mg tablets Aripiprazole Mylan Pharma 30 mg tablets aripiprazole
Aripiprazole Mylan Pharma 5 mg tablete Aripiprazole Mylan Pharma 10 mg tablete Aripiprazole Mylan Pharma 15 mg tablete Aripiprazole Mylan Pharma 30 mg tablete
Aripiprazole also demonstrated a comparable proportion of patients in symptomatic remission from mania as lithium or haloperidol at week 12.
Sličan udio bolesnika imao je simptomatsku remisiju manije uz aripiprazol kao i uz litij ili haloperidol u 12. tjednu.
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.
U drugom ispitivanju od 12 tjedana, incidencija EPS-a bila je 26,6 % u bolesnika liječenih aripiprazolom i 17,6 % u onih liječenih litijem.
Aripiprazole Mylan Pharma is for oral use.
Aripiprazole Mylan Pharma je namijenjen za peroralnu primjenu.
In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107 %, while Cmax was unchanged.
Kinidin i drugi inhibitori CYP2D6 U kliničkom ispitivanju sa zdravim ispitanicima, jaki inhibitor CYP2D6 (kinidin) povećao je površinu ispod krivulje (AUC) aripiprazola za 107 %, dok je maksimalna koncentracija (Cmax) ostala neizmijenjena.
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).
Kad se prekida primjena induktora enzima CYP3A4 u sklopu kombinirane terapije, onda se mora smanjiti doza aripiprazola na preporučenu dozu (vidjeti dio 4.5).
Akathisia
Akatizija
Aripiprazole Mylan Pharma with food, drink and alcohol This medicine can be taken regardless of meals.
Aripiprazole Mylan Pharma s hranom, pićem i alkoholom
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.
Djelotvornost aripiprazola također je bila procijenjena u fleksibilnom rasponu doza od 2 mg na dan do 20 mg na dan uz početnu dozu od 2 mg u pedijatrijskih ispitanika s Touretteovim sindromom (aripiprazol: n = 32, placebo: n = 29) u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 10 tjedana provedenom u Južnoj Koreji.
• The other ingredients for 5 mg are crystalline maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, indigo carmine (E132) and magnesium stearate.
• Drugi sastojci za 5 mg kristalinična maltoza, mikrokristalnu celulozu, preželatinizirani škrob, natrij kroskarmeloza, indigo karmin (E132) i magnezijev stearat.
In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of EPS was 18.2 % for aripiprazole-treated patients and 15.7 % for placebo-treated patients.
U dugotrajnoj fazi terapije održavanja u trajanju od 26 tjedana u sklopu jednog placebom kontroliranog ispitivanja, incidencija EPS-a bila je 18,2 % u bolesnika liječenih aripiprazolom i 15,7 % u bolesnika koji su primali placebo.
Haemodialysis
Hemodijaliza
Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69 % and 71 % lower, respectively, than those following treatment with aripiprazole alone.
Slično tome, geometrijski određena srednja vrijednost Cmax dehidro-aripiprazola nakon zajedničke primjene s karbamazepinom bila je manja za 69 %, a AUC-a za
Reproductive system and breast disorders
Poremećaji reproduktivnog sustava i dojki prijapizam
Tablet coat
Ovojnica tablete
NAME OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S
Nositelj odobrenja za stavljanje lijeka u promet Mylan S.A.S,
The incidences of the Adverse Drug Reactions (ADRs) associated with aripiprazole therapy are tabulated below.
Incidencija nuspojava povezanih s terapijom aripiprazolom prikazana je u tablici niže.
When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased (see section 4.5).
Kad se prestane s primjenom inhibitora enzima CYP3A4 ili CYP2D6 u sklopu kombinirane terapije, onda se doza aripiprazola mora povisiti (vidjeti dio 4.5).
In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
U dva trotjedna, placebom kontrolirana ispitivanja monoterapije fleksibilnom dozom u bolesnika s maničnim ili miješanim epizodama bipolarnog poremećaja tipa I, aripiprazol je pokazao nadmoćnu djelotvornost u odnosu na placebo u smanjenju maničnih simptoma tijekom 3 tjedna.
In a long term 26-week placebo-controlled trial, the incidence of EPS was 19 % for aripiprazole-treated patients and 13.1 % for placebo-treated patients.
U dugotrajnom placebom kontroliranom ispitivanju u trajanju od 26 tjedana, incidencija EPS-a bila je 19 % u bolesnika liječenih aripiprazolom i 13,1 % u bolesnika koji su primali placebo.
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: u dugotrajnom kontroliranom ispitivanju u trajanju od 52 tjedna, bolesnici liječeni aripiprazolom imali su nižu ukupnu incidenciju (25,8 %) EPS-a uključujući parkinsonizam, akatiziju,
When concomitant administration of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, the aripiprazole dose should be reduced.
Kad se istodobno s aripiprazolom primjenjuju jaki inhibitori CYP3A4 ili CYP2D6, mora se smanjiti doza aripiprazola.
Aggression
Napadaji
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.
I u djece i adolescenata Aripiprazol se ispitivao u 30-tjednom placebom kontroliranom ispitivanju u kojem je sudjelovalo 296 djece i adolescenata (10-17 godina) koji su zadovoljavali DSM-IV kriterije za bipolarni poremećaj tipa
• The other ingredients for 10, 30 mg are crystalline maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, iron oxide red (E172) and magnesium stearate.
Drugi sastojci za 10, 30 mg kristalinična maltoza, mikrokristalnu celulozu, preželatinizirani škrob, natrij kroskarmeloza, željezni crveni oksid (E172) i magnezijev stearat.
In another long-term 26-week controlled trial, the incidence of EPS was 14.8 % for aripiprazole-treated patients and 15.1 % for olanzapine-treated patients.
U drugom dugotrajnom kontroliranom ispitivanju od 26 tjedana, incidencija EPS-a bila je 14,8 % u bolesnika liječenih aripiprazolom i 15,1 % u bolesnika liječenih olanzapinom.
Schizophrenia in adolescents aged 15 years and older: the recommended dose for aripiprazole is 10 mg/day administered on a once-a-day schedule without regard to meals.
Shizofrenija u adolescenata u dobi od 15 i više godina: preporučena doza za Aripiprazole Mylan Pharma je 10 mg/dan primijenjena jedanput dnevno neovisno o obroku.
Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).
I te za prevenciju nove manične epizode u odraslih osoba s pretežno maničnim epizodama u kojih su prethodne manične epizode odgovorile na liječenje aripiprazolom (vidjeti dio 5.1).
In both of these short term trials, the clinical relevance of the efficacy findings has not been established, considering the magnitude of treatment effect compared to the large placebo effect and the unclear effects regarding psycho-social functioning.
S obzirom na veličinu terapijskog učinka u odnosu na veliki učinak placeba i nejasne učinke u pogledu psihosocijalnog funkcioniranja, u ova dva kratkotrajna ispitivanja nije ustanovljena klinička važnost pronađene djelotvornosti.
The AUC and Cmax of dehydroaripiprazole increased by 77 % and 43 %, respectively.
AUC dehidro-aripiprazola povisio se za 77 %, a Cmax za
• The other ingredients for 15 mg are crystalline maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, iron oxide yellow (E172) and magnesium stearate.
• Drugi sastojci za 15 mg kristalinična maltoza, mikrokristalnu celulozu, preželatinizirani škrob, natrij kroskarmeloza, žuti željezov oksid (E172) i magnezijev stearat.
Aripiprazole Mylan Pharma 30 mg tablets
Aripiprazole Mylan Pharma 30 mg tablete
Pink, oval and biconvex tablets of 17.1 mm in length, 8.1 mm in width, engraved with “30” on one side
Pink, ovalni i bikonveksne tablete 17.1mm duljine, širine 8.1mm u i "30" na jednoj strani.
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.
I sa ili bez psihotičnih značajki i djelomičnim nedostatkom odgovora na monoterapiju litijem ili valproatom tijekom 2 tjedna pri terapijskim razinama tih lijekova u serumu, dodatak aripiprazola kao adjuvantne terapije pokazao je nadmoćnu djelotvornost u smanjenju maničnih simptoma u odnosu na monoterapiju litijem ili valproatom.
In two long term trials with adolescent (13-17 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.
U dva dugotrajna ispitivanja adolescentnih bolesnika (u dobi od 13 do 17 godina) sa shizofrenijom i bipolarnim poremećajem liječenih aripiprazolom, incidencija niskih razina prolaktina u serumu u djevojaka (< 3 ng/ml) iznosila je 37,0 %, a u mladića (< 2 ng/ml) 59,4 %.
LIST OF EXCIPIENTS Contains maltose.
Sadrži maltoza.
• muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.
Drugi simptomi mogu uključivati: akutnu smetenost, napadaje (epilepsiju), komu, kombinaciju vrućice, ubrzanog disanja, znojenja, ukočenosti mišića i omamljenosti ili pospanosti, usporeno disanje, gušenje, visok ili nizak krvni tlak, abnormalni srčani ritam.
When concomitant administration of strong CYP3A4 inducers with aripiprazole occurs, the aripiprazole dose should be increased.
Kad se istodobno s aripiprazolom primjenjuju jaki induktori CYP3A4, doza aripiprazola mora se povisiti.
Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
Kao i ostali lijekovi, i aripiprazol može izazvati reakcije preosjetljivosti, čije su značajke alergijski simptomi (vidjeti dio 4.8).
Aripiprazole Mylan Pharma 30 mg tablets are pink, oval and biconvex of 17.1mm in length, 8.1 mm in width, engraved with ‘30' on one side.
Aripiprazol Mylan Pharma 30 mg tablete su ružičaste, ovalne i bikonveksan od 17.1mm duljine, širine 8.1mm u, s ugraviranim "30" na jednoj strani.
Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors, may be expected to have similar effects and similar dose reductions should therefore be applied (see section 4.2).
Slični učinci mogu se očekivati i od drugih jakih inhibitora CYP3A4, kao što su itrakonazol i inhibitori HIV proteaze pa se stoga moraju provesti slična smanjenja doze.
What Aripiprazole Mylan Pharma contains
Što lijek Aripiprazole Mylan Pharma sadrži
In the adolescent (13-17 years) schizophrenia population with aripiprazole exposure of 5 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.
17 godina) sa shizofrenijom koji su bili izloženi aripiprazolu u dozi od 5 do 30 mg do 72 mjeseca, incidencija niskih razina prolaktina u serumu u djevojaka (< 3 ng/ml) iznosila je 25,6 %, a u mladića (< 2 ng/ml) 45,0 %.
Excipient with known effect 168 mg of maltose per tablet
Pomoćna tvar s poznatim učinkom 168 mg na maltozu po tableti
In one 3-week, fixed-dose, placebo-controlled monotherapy trial involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole failed to demonstrate superior efficacy to placebo.
U jednom trotjednom, placebom kontroliranom ispitivanju monoterapije fiksnom dozom koje je uključilo bolesnike s maničnom ili miješanom epizodom bipolarnog poremećaja tipa I, aripiprazol se nije pokazao djelotvornijim od placeba.
Nervousness
Preosjetljivost
USE C.
U PROMET D.