natgillin/translations-raw huggingface dataset:
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
15 (rabdomioliza) in akutna odpoved ledvic.
15 4.5 Interaction with other medicinal products and other forms of interaction
16 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
John's Wort) may be expected to have similar effects and similar dose increases should therefore be applied.
Pričakovati je mogoče, da imajo drugi močni induktorji CYP3A4 (npr. rifampicin, rifabutin, fenitoin, fenobarbital, primidon, efavirenz, nevirapin in šentjanževka) podobne učinke, zato je treba odmerjanje podobno zvečati.
Upon discontinuation of potent CYP3A4 inducers, the dosage of ABILIFY should be reduced to the recommended dose.
Po prenehanju uporabe močnih induktorjev CYP3A4 je treba odmerjanje zdravila ABILIFY zmanjšati na priporočeni odmerek.
16 When either valproate or lithium were administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations.
Med sočasno uporabo aripiprazola z litijem ali valproatom se koncentracija aripiprazola ni klinično pomembno spremenila.
Potential for ABILIFY to affect other medicinal products:
17 Možnost vpliva zdravila ABILIFY na druga zdravila:
17 Extrapyramidal symptoms (EPS):
Ekstrapiramidni simptomi (EPS):
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.
18 incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 19% in pri bolnikih, ki so dobivali placebo, 13, 1%.
Post-Marketing:
19 Pomarketinške izkušnje:
19 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 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
Učinkovitost aripiprazola pri shizofreniji in bipolarni I motnji je domnevno posledica kombinacije delnega agonizma na dopaminskih receptorjih D2 in serotoninskih receptorjih 5- HT1a ter antagonizma na serotoninskih receptorjih 5- HT2a.
Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors.
21 In vitro je imel aripiprazol veliko vezavno afiniteto za dopaminske receptorje D2 in D3 in za serotoninske receptorje 5- HT1a in 5- HT2a ter zmerno afiniteto za dopaminske receptorje D4, serotoninske receptorje 5- HT2c in 5- HT7, adrenergične receptorje alfa- 1 in histaminske receptorje H1.
20 In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who achieved remission on aripiprazole during a stabilization phase prior to randomization, aripiprazole demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into depression.
22 V 26- tedenskem s placebom nadzorovanem preskušanju, ki mu je sledil 74- tedenski podaljšek, je bil pri bolnikih z manijo, pri katerih je bila dosežena remisija z aripiprazolom med stabilizacijsko fazo pred randomizacijo, aripiprazol učinkovitejši od placeba pri preprečevanju ponovitve bipolarne motnje, predvsem pri preprečevanju ponovitve v manijo, pri preprečevanju v depresijo pa ni bil učinkovitejši od placeba.
21 Hepatic Disease:
23 Bolezen jeter:
Red iron oxide (E172)
Rdeč železov oksid (E172)
6.3 Shelf life
24 6. 3 Rok uporabnosti
22 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
57 mg lactose per tablet
57 mg laktoze na tableto.
Tablet Round and yellow, engraved with "A-009" and "15" on one side.
Okrogle oblike in rumene barve z vrezano oznako “ A- 009 ” in “ 15 ” na eni strani.
24 maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
Največji dnevni odmerek 30 mg je treba pri bolnikih s hudo okvaro jeter uporabljati previdno (glejte poglavje 5. 2).
Patients with renal impairment: no dosage adjustment is required in patients with renal impairment.
26 Bolniki z okvaro ledvic: pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
27 (rabdomioliza) in akutna odpoved ledvic.
26 4.5 Interaction with other medicinal products and other forms of interaction
28 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
27 When either valproate or lithium were administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations.
Med sočasno uporabo aripiprazola z litijem ali valproatom se koncentracija aripiprazola ni klinično pomembno spremenila.
Potential for ABILIFY to affect other medicinal products:
29 Možnost vpliva zdravila ABILIFY na druga zdravila:
28 Extrapyramidal symptoms (EPS):
Ekstrapiramidni simptomi (EPS):
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.
30 incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 19% in pri bolnikih, ki so dobivali placebo, 13, 1%.
Post-Marketing:
31 Pomarketinške izkušnje:
30 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 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
Učinkovitost aripiprazola pri shizofreniji in bipolarni I motnji je domnevno posledica kombinacije delnega agonizma na dopaminskih receptorjih D2 in serotoninskih receptorjih 5- HT1a ter antagonizma na serotoninskih receptorjih 5- HT2a.
Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors.
33 In vitro je imel aripiprazol veliko vezavno afiniteto za dopaminske receptorje D2 in D3 in za serotoninske receptorje 5- HT1a in 5- HT2a ter zmerno afiniteto za dopaminske receptorje D4, serotoninske receptorje 5- HT2c in 5- HT7, adrenergične receptorje alfa- 1 in histaminske receptorje H1.
31 In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who achieved remission on aripiprazole during a stabilization phase prior to randomization, aripiprazole demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into depression.
34 V 26- tedenskem s placebom nadzorovanem preskušanju, ki mu je sledil 74- tedenski podaljšek, je bil pri bolnikih z manijo, pri katerih je bila dosežena remisija z aripiprazolom med stabilizacijsko fazo pred randomizacijo, aripiprazol učinkovitejši od placeba pri preprečevanju ponovitve bipolarne motnje, predvsem pri preprečevanju ponovitve v manijo, pri preprečevanju v depresijo pa ni bil učinkovitejši od placeba.
32 Hepatic Disease:
35 Bolezen jeter:
Yellow iron oxide (E172)
Rumen železov oksid (E172)
6.3 Shelf life
36 6. 3 Rok uporabnosti
33 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
186.54 mg lactose per tablet
186, 54 mg laktoze na tableto.
Tablet Round and pink, engraved with "A-011" and "30" on one side.
Okrogle oblike in roza barve z vrezano oznako “ A- 011 ” in “ 30 ” na eni strani.
35 maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
Največji dnevni odmerek 30 mg je treba pri bolnikih s hudo okvaro jeter uporabljati previdno (glejte poglavje 5. 2).
Patients with renal impairment: no dosage adjustment is required in patients with renal impairment.
38 Bolniki z okvaro ledvic: pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
39 (rabdomioliza) in akutna odpoved ledvic.
37 4.5 Interaction with other medicinal products and other forms of interaction
40 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
38 When either valproate or lithium were administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations.
Med sočasno uporabo aripiprazola z litijem ali valproatom se koncentracija aripiprazola ni klinično pomembno spremenila.
Potential for ABILIFY to affect other medicinal products:
41 Možnost vpliva zdravila ABILIFY na druga zdravila:
39 Extrapyramidal symptoms (EPS):
Ekstrapiramidni simptomi (EPS):
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.
42 incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 19% in pri bolnikih, ki so dobivali placebo, 13, 1%.
Post-Marketing:
43 Pomarketinške izkušnje:
41 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 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
Učinkovitost aripiprazola pri shizofreniji in bipolarni I motnji je domnevno posledica kombinacije delnega agonizma na dopaminskih receptorjih D2 in serotoninskih receptorjih 5- HT1a ter antagonizma na serotoninskih receptorjih 5- HT2a.
Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors.
45 In vitro je imel aripiprazol veliko vezavno afiniteto za dopaminske receptorje D2 in D3 in za serotoninske receptorje 5- HT1a in 5- HT2a ter zmerno afiniteto za dopaminske receptorje D4, serotoninske receptorje 5- HT2c in 5- HT7, adrenergične receptorje alfa- 1 in histaminske receptorje H1.
42 In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who achieved remission on aripiprazole during a stabilization phase prior to randomization, aripiprazole demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into depression.
46 V 26- tedenskem s placebom nadzorovanem preskušanju, ki mu je sledil 74- tedenski podaljšek, je bil pri bolnikih z manijo, pri katerih je bila dosežena remisija z aripiprazolom med stabilizacijsko fazo pred randomizacijo, aripiprazol učinkovitejši od placeba pri preprečevanju ponovitve bipolarne motnje, predvsem pri preprečevanju ponovitve v manijo, pri preprečevanju v depresijo pa ni bil učinkovitejši od placeba.
43 Hepatic Disease:
47 Bolezen jeter:
6.3 Shelf life
48 6. 3 Rok uporabnosti
44 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
2 mg aspartame (E951) per orodispersible tablet
2 mg aspartama (E951) na orodisperzibilno tableto
Orodispersible tablet Round and pink, marked with "A" over "640" on one side and "10" on the other.
Orodisperzibilna tableta Okrogle oblike in roza barve, označene z "A" nad "640" na eni strani in 10 na drugi.
ABILIFY is effective in a dose range of 10 to 30 mg/ day.
Zdravilo ABILIFY je učinkovito v odmernem območju od 10 do 30 mg/ dan.
The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disperse in saliva.
Orodisperzibilne tablete mora bolnik položiti v usta na jezik, kjer v slini hitrorazpadejo.
46 The orodispersible tablets may be used as an alternative to ABILIFY tablets for patients who have difficulty to swallow ABILIFY tablets (see also section 5.2).
50 Orodisperzibilne tablete lahko kot zamenjavo za tablete ABILIFY uporabljajo bolniki, ki tablete ABILIFY težko pogoltnejo (glejte tudi poglavje 5. 2).
However, the maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
Največji dnevni odmerek 30 mg je treba pri bolnikih s hudo okvaro jeter uporabljati previdno (glejte poglavje 5. 2).
Patients with renal impairment: no dosage adjustment is required in patients with renal impairment.
Bolniki z okvaro ledvic: pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
Smoking status: 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).
47 Tardive Dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
Če se pri bolniku, ki dobiva
If signs and symptoms of tardive dyskinesia appear in a patient on ABILIFY, dose reduction or discontinuation should be considered.
51 ABILIFY, pojavijo znaki in simptomi zapoznele diskinezije, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Klinični znaki MNS so hiperpireksija, mišična rigidnost, spremenjeno duševno stanje in znaki avtonomne nestabilnosti (nereden srčni utrip ali krvni tlak, tahikardija, znojenje in motnje srčnega ritma).
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Med dodatnimi znaki so lahko zvišana kreatin- fosfokinaza, mioglobinurija (rabdomioliza) in akutna odpoved ledvic.
Hyperglycaemia and Diabetes Mellitus: hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotic agents, including ABILIFY.
Hiperglikemija in diabetes mellitus: pri bolnikih, zdravljenih z atipičnimi antipsihotiki, vključno z zdravilom ABILIFY, je bila opisana hiperglikemija.
48 Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
52 Disfagija: z uporabo antipsihotičnih zdravil, tudi zdravila ABILIFY, so bile povezane motnje motilitete požiralnika in aspiracija.
ABILIFY orodispersible tablets contain aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria.
Bolniki s fenilketonurijo: orodisperzibilne tablete ABILIFY vsebujejo aspartam; ta je vir fenilalanina, ki je lahko škodljiv za bolnike s fenilketonurijo.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
49 of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
Podobno je bila po sočasni uporabi karbamazepina geometrična sredina Cmax dehidroaripiprazola za 69% nižja, njegova AUC pa za 71% nižja kot po zdravljenju s samim aripiprazolom.
ABILIFY dose should be doubled when concomitant administration of ABILIFY occurs with carbamazepine.
53 Med sočasno uporabo zdravila ABILIFY s karbamazepinom je treba odmerek zdravila ABILIFY podvojiti.
Potential for ABILIFY to affect other medicinal products:
Možnost vpliva zdravila ABILIFY na druga zdravila:
50 Cardiac disorders Uncommon: tachycardia* Nervous System disorders Common: extrapyramidal disorder, akathisia, tremor, dizziness, somnolence, sedation, headache Eye disorders Common: blurred vision Gastrointestinal disorders Common: dyspepsia, vomiting, nausea, constipation, salivary hypersecretion Vascular disorders Uncommon: orthostatic hypotension* General disorders and administration site conditions Common: fatigue Psychiatric disorders Common: restlessness, insomnia, anxiety Uncommon: depression*
54 Srčne bolezni Občasni: tahikardija * Bolezni živčevja Pogosti: ekstrapiramidne motnje, akatizija, tremor, omotica, somnolenca, sedacija, glavobol Očesne bolezni Pogosti: zamegljen vid Bolezni prebavil Pogosti: dispepsija, bruhanje, navzea, zaprtost, močnejše izločanje sline Žilne bolezni Občasni: ortostatska hipotenzija * Splošne težave in spremembe na mestu aplikacije Pogosti: utrujenost Psihiatrične motnje Pogosti: nemir, nespečnost, anksioznost Občasni: depresija *
Extrapyramidal symptoms (EPS):
Ekstrapiramidni simptomi (EPS):
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.
V dolgoročnem 26- tedenskem s placebom kontroliranem preizkušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 19%, pri bolnikih, ki so dobivali placebo, pa 13, 1%.
Post-Marketing:
55 Pomarketinške izkušnje:
51 Nervous system disorders:
BOLEZNI ŽIVČEVJA:
52 Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41% and AUC by about 51%, suggesting that charcoal may be effective in the treatment of overdose.
Aktivno oglje (50 g), uporabljeno eno uro po aripiprazolu, je zmanjšalo Cmax aripiprazola za okrog 41% in AUC za okrog 51%, kar kaže, da bi bilo oglje lahko učinkovito za zdravljenje prevelikega odmerjanja.
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 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
Učinkovitost aripiprazola pri shizofreniji in bipolarni I motnji je domnevno posledica kombinacije delnega agonizma na dopaminskih receptorjih D2 in serotoninskih receptorjih 5- HT1a ter antagonizma na serotoninskih receptorjih 5- HT2a.
Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors.
In vitro je imel aripiprazol veliko vezavno afiniteto za dopaminske receptorje D2 in D3 in za
Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for muscarinic receptors.
57 serotoninske receptorje 5- HT1a in 5- HT2a ter zmerno afiniteto za dopaminske receptorje D4, serotoninske receptorje 5- HT2c in 5- HT7, adrenergične receptorje alfa- 1 in histaminske receptorje H1.
Interaction with receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of aripiprazole.
Aripiprazol je imel tudi zmerno vezavno afiniteto za mesta ponovnega prevzema serotonina in nobene opazne afinitete za muskarinske receptorje.
In a 26-week, placebo-controlled trial in stabilised patients with chronic schizophrenia, aripiprazole had significantly greater reduction in relapse rate, 34% in aripiprazole group and 57% in placebo.
V 26- tedenski s placebom kontrolirani raziskavi stabiliziranih bolnikov s kronično shizofrenijo je aripiprazol značilno bolj zmanjšal delež recidivov: v skupini, ki je dobivala aripiprazol, jih je bilo 34%, v tisti, ki je dobivala placebo, pa 57%.
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
V dveh 3- tedenskih s placebom nadzorovanih preskušanjih samostojnega zdravljenja s fleksibilnim odmerkom pri bolnikih z manično ali mešano epizodo bipolarne I motnje se je po 3 tednih izkazalo, da je aripiprazol pri zmanjšanju maničnih simptomov učinkovitejši od placeba.
In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who achieved remission on aripiprazole during a stabilization phase prior to randomization, aripiprazole demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into depression.
58 V 26- tedenskem s placebom nadzorovanem preskušanju, ki mu je sledil 74- tedenski podaljšek, je bil pri bolnikih z manijo, pri katerih je bila dosežena remisija z aripiprazolom med stabilizacijsko fazo pred randomizacijo, aripiprazol učinkovitejši od placeba pri preprečevanju ponovitve bipolarne motnje, predvsem pri preprečevanju ponovitve v manijo, pri preprečevanju v depresijo pa ni bil učinkovitejši od placeba.
Aripiprazole orodispersible tablet is bioequivalent to aripiprazole tablets, with a similar rate and extent of absorption.
Absorbirajo se podobno hitro in v podobni meri.
Aripiprazole orodispersible tablets may be used as an alternative to aripiprazole tablets.
Orodisperzibilne tablete aripiprazola je mogoče uporabiti kot zamenjavo za tablete aripiprazola.
54 Pharmacokinetics in special patient groups
Farmakokinetika v posebnih skupinah bolnikov
Renal Disease:
59 Bolezen ledvic:
Hepatic Disease:
Bolezen jeter:
Calcium silicate Croscarmellose sodium Crospovidone Silicon dioxide Xylitol Microcrystalline cellulose Aspartame (E951) Acesulfame potassium Vanilla flavour (including vanillin and ethyl vanillin) Tartaric acid Magnesium stearate
kalcijev silikat premreženi natrijev karmelozat krospovidon silicijev dioksid ksilitol mikrokristalna celuloza aspartam (E951) kalijev acesulfamat
6.3 Shelf life
6. 3 Rok uporabnosti
6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
Carton of 14 x 1 tablets in cold-formed aluminium perforated unit dose blisters.
Škatla s 14 x 1 tableto v perforiranem pretisnem omotu za enkratni odmerek iz hladno oblikovanega aluminija.
Carton of 28 x 1 tablets in cold-formed aluminium perforated unit dose blisters.
Škatla z 28 x 1 tableto v perforiranem pretisnem omotu za enkratni odmerek iz hladno oblikovanega aluminija.
Carton of 49 x 1 tablets in cold-formed aluminium perforated unit dose blisters.
Škatla z 49 x 1 tableto v perforiranem pretisnem omotu za enkratni odmerek iz hladno oblikovanega aluminija.
56 Date of first authorisation:
Datum pridobitve dovoljenja za promet:
3 mg aspartame (E951) per orodispersible tablet
3 mg aspartama (E951) na orodisperzibilno tableto
Orodispersible tablet Round and yellow, marked with "A" over "641" on one side and "15" on the other.
Orodisperzibilna tableta Okrogle oblike in rumene barve, označene z "A" nad "641" na eni strani in 15 na drugi.
58 The orodispersible tablets may be used as an alternative to ABILIFY tablets for patients who have difficulty to swallow ABILIFY tablets (see also section 5.2).
62 Orodisperzibilne tablete lahko kot zamenjavo za tablete ABILIFY uporabljajo bolniki, ki tablete ABILIFY težko pogoltnejo (glejte tudi poglavje 5. 2).
59 Tardive Dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
Če se pri bolniku, ki dobiva
If signs and symptoms of tardive dyskinesia appear in a patient on ABILIFY, dose reduction or discontinuation should be considered.
63 ABILIFY, pojavijo znaki in simptomi zapoznele diskinezije, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.
60 Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
64 Disfagija: z uporabo antipsihotičnih zdravil, tudi zdravila ABILIFY, so bile povezane motnje motilitete požiralnika in aspiracija.
61 of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
Podobno je bila po sočasni uporabi karbamazepina geometrična sredina Cmax dehidroaripiprazola za 69% nižja, njegova AUC pa za 71% nižja kot po zdravljenju s samim aripiprazolom.
ABILIFY dose should be doubled when concomitant administration of ABILIFY occurs with carbamazepine.
65 Med sočasno uporabo zdravila ABILIFY s karbamazepinom je treba odmerek zdravila ABILIFY podvojiti.