natgillin/translations-raw huggingface dataset:
In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic patients, presenting with positive or negative symptoms, oral aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Uporaba peroralnega aripiprazola pri shizofreniji: v treh kratkotrajnih (4 - do 6- tedenskih) s placebom nadzorovanih preskušanjih, ki sta vključevali 1. 228 shizofrenih bolnikov, ki so imeli pozitivne ali negativne simptome, je peroralni aripiprazol dosegel statistično značilno večje izboljšanje psihotičnih simptomov kot placebo.
ABILIFY is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Zdravilo ABILIFY učinkovito vzdržuje klinično izboljšanje med nadaljevalnim zdravljenjem bolnikov, ki se uvodoma odzovejo na terapijo.
In a haloperidol-controlled trial, the proportion of responder patients maintaining response to medicinal product at 52-weeks was similar in both groups (oral aripiprazole 77% and haloperidol 73%).
V preskušanju, nadzorovanim s haloperidolom, je bil delež odzivnih bolnikov, pri katerih se je odziv na zdravilo ohranil po 52 tednih, v obeh skupinah podoben (peroralni aripiprazol 77% in haloperidol 73%).
The overall completion rate was significantly higher for patients on oral aripiprazole (43%) than for oral haloperidol (30%).
Celotni delež dokončanja je bil pri bolnikih, ki so dobivali peroralni aripiprazol, značilno večji (43%) kot pri tistih, ki so dobivali peroralni haloperidol (30%).
Actual scores in rating scales used as secondary endpoints, including PANSS and the Montgomery-Asberg Depression Rating Scale showed a significant improvement over haloperidol.
Dejanske ocene po ocenjevalnih lestvicah (vključno s PANSS in lestvico Montgomery- Asberg Depression Rating Scale), ki so predstavljale sekundarne opazovane dogodke, so pokazale značilno izboljšanje v primerjavi s haloperidolom.
In a 26-week, placebo-controlled trial in stabilised patients with chronic schizophrenia, oral aripiprazole had significantly greater reduction in relapse rate, 34% in oral aripiprazole group and 57% in placebo.
V 26- tedenskem, s placebom nadzorovanem preskušanju stabiliziranih bolnikov s kronično shizofrenijo je peroralni aripiprazol značilno bolj zmanjšal delež recidivov: v skupini, ki je dobivala aripiprazol peroralno, jih je bilo 34%, v tisti, ki je dobivala placebo, pa 57%.
Weight gain: in clinical trials oral aripiprazole has not been shown to induce clinically relevant weight gain.
Izvedena je bila 26- tedenska z olanzapinom nadzorovana, dvojno slepa multinacionalna študija shizofrenije, ki je zajela 314 bolnikov; primarni opazovani dogodek pa je bil zvečanje telesne mase.
In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 patients and where the primary end-point 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 oral aripiprazole (N= 18, or 13% of evaluable patients), compared to oral olanzapine (N= 45, or 33% of evaluable patients).
V tej študiji je bilo zvečanje telesne mase za vsaj 7% nad izhodiščno (t. j. 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).
Manic episodes in Bipolar I Disorder with oral aripiprazole:
Uporaba peroralnega aripiprazola pri maničnih epizodah pri bipolarni motnji I:
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.
V dveh 3- tedenskih s placebom nadzorovanih preskušanjih samostojnega zdravljenja s fleksibilnim odmerkom pri bolnikih z manično ali mešano epizodo bipolarne motnje I se je po 3 tednih izkazalo, da
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.
V enem 3- tedenskem s placebom nadzorovanem preskušanju samostojnega zdravljenja s fiksnim odmerkom pri bolnikih z manično ali mešano epizodo bipolarne motnje I aripiprazol ni bil učinkovitejši od placeba.
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, 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.
102 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.
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 solution for injection administered intramuscularly as a single-dose to healthy subjects is well absorbed and has an absolute bioavailability of 100%.
Absolutna biološka uporabnost je 100- odstotna.
The aripiprazole AUC in the first 2 hours after an intramuscular injection was 90% greater than the AUC after the same dose as a tablet; systemic exposure was generally similar between the 2 formulations.
Sistemska izpostavljenost je na splošno enaka pri obeh farmacevtskih oblikah.
Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/ kg, indicating extensive extravascular distribution.
Aripiprazol se široko porazdeli po telesu in ima navidezni volumen porazdelitve 4, 9 l/ kg, kar kaže na izdatno zunajžilno porazdelitev.
Pharmacokinetics in special patient groups
109 Farmakokinetika pri posebnih skupinah bolnikov
103 Renal Disease:
Bolezen ledvic:
Administration of aripiprazole solution for injection was well tolerated and produced no direct target organ toxicity in rats or monkeys after repeated dosing at systemic exposures (AUC) that were 15 and 5 times, respectively, human exposure at the maximum recommended human dose of 30 mg intramuscular.
Neposredne toksičnosti za ciljne organe niso opazili.
In intravenous reproductive toxicity studies, no new safety concerns were observed at maternal exposures up to 15 (rat) and 29 (rabbit) times human exposure at 30 mg.
Pri izpostavljenosti mater, ki je bila 15 - krat (podgane) in 29- krat (kunčice) večja od izpostavljenosti človeka pri 30 mg odmerku pri študijah vplivov na sposobnost razmnoževanja po intravenskem dajanju niso ugotovili dodatnih težav glede varnosti.
Non-clinical safety data revealed no special hazard for humans based on conventional oral aripiprazole studies of safety pharmacology, repeat-dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Predklinični podatki o varnosti peroralnega aripiprazola na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Toxicologically significant effects were observed only at doses or exposures that were sufficiently in excess of the maximum human dose or exposure, indicating that these effects were limited or of no relevance to clinical use.
Toksikološko pomembne učinke so opazili le pri odmerkih ali izpostavljenosti, ki so/ je močno presegali/ presegla največje odmerke ali izpostavljenost pri človeku; kar kaže, da so ti učinki za klinično uporabo le omejenega pomena ali celo nepomembni.
An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of hydroxy metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 to 125 mg/ kg/ day (1 to 3 times the mean steady-state AUC at the maximum recommended clinical dose 2 or 16 to 81 times the maximum recommended human dose based on mg/ m).
Dodaten izsledek je bila holelitiaza zaradi precipitacije sulfatnih konjugatov hidroksipresnovkov aripiprazola v žolču opic po ponavljajočem odmerjanju od 25 do 125 mg/ kg/ dan (1 - do 3- kratna srednja AUC v stanju dinamičnega ravnovesja ob največjem priporočenem kliničnem odmerku ali 16 - do 81- kratni največji priporočeni odmerek za človeka glede na mg/ m2).
However, the concentrations of the sulphate conjugates of hydroxy aripiprazole in human bile at the highest dose proposed, 30 mg per day, were no more than 6% of the bile concentrations found in the monkeys in the 39-week study and are well below (6%) their limits of in vitro solubility.
Vendar je bila koncentracija sulfatnih konjugatov hidroksiaripiprazola v človeškem žolču v 39- tedenski raziskavi ob
Based on results of a full range of standard genotoxicity tests, aripiprazole was considered non-genotoxic.
110 največjem priporočenem odmerku 30 mg na dan le 6% koncentracije v žolču pri opicah ter je bila bistveno pod mejo (6%) njihove topnosti in vitro.
Aripiprazole did not impair fertility in reproductive toxicity studies.
Na podlagi celotnega spektra standardnih preizkusov genotoksičnosti je bilo ocenjeno, da aripiprazol ni genotoksičen.
Sulfobutylether β -cyclodextrin (SBECD) Tartaric acid Sodium hydroxide Water for injection
sulfobutileter betaciklodekstrin (SBECD) vinska kislina natrijev hidroksid voda za injekcije
104 6.2 Incompatibilities
6. 2 Inkompatibilnosti
18 months Use product immediately after opening and discard any unused amount.
Neporabljeno količino zdravila zavrzite.
Each carton contains one single-use type I glass vial with a rubber butyl stopper and a "flip-off" aluminium seal.
Vsaka škatla vsebuje eno vialo za enkratno uporabo iz stekla tipa I, zaprto z zamaškom iz butilne gume in aluminijasto zaporko » flip- off «..
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
105 ANNEX II
112 DODATEK II
A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
B CONDITIONS OF THE MARKETING AUTHORISATION
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
106 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Bristol-Myers Squibb Srl Contrada Fontana Del Ceraso I-03012 Anagni-Frosinone Italy
Contrada Fontana del Ceraso I- 03012 Anagni- Frosinone Italija
Otsuka Pharmaceutical Europe Ltd commits to provide a PSUR at 6 monthly intervals unless otherwise decided by the CHMP.
Otsuka Pharmaceutical Europe Ltd se obvezuje, da bo periodična poročila o varnosti zdravila (PSUR) predajal v 6- mesečnih presledkih, če Odbor za zdravila za uporabo v humani medicini (CHMP) ne odloči drugače.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora pred začetkom trženja zdravila vzpostaviti sistem farmakovigilance, kot je opisan v različici 1. 0 v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, in ga vzdrževati ves čas trženja zdravila.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici 3. 0 načrta za obvladovanje tveganja (RMP) v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vse naknadne dopolnitve načrta za obvladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami Odbora za zdravila za uporabo v humani medicini za sisteme obvladovanja tveganja za zdravila za uporabo v humani medicini je treba dopolnjen načrt za obvladovanje tveganja predložiti sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA
Poleg tega je dopolnjen načrt za obvladovanje tveganja treba predložiti ko se pridobijo novi podatki, ki lahko vplivajo na trenutne podatke o varnosti, načrt farmakovigilance ali aktivnosti za zmanjševanje tveganja. v 60 dneh po pomembnem novem spoznanju (farmakovigilančnem ali povezanem z zmanjševanjem tveganja). na zahtevo Evropske agencije za zdravila (EMEA).
107 ANNEX III
114 DODATEK III
108 A.
115 A.
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
116 PODATKI NA ZUNANJI OVOJNINI
METHOD AND ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT( I) UPORABE ZDRAVILA
EXP
Uporabno do:
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
111 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
118 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAK
112 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
119 PODATKI NA ZUNANJI OVOJNINI
113 10.
120 10.
114 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
121 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAK
115 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
122 PODATKI NA ZUNANJI OVOJNINI
116 10.
123 10.
117 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
124 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAK
118 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
125 PODATKI NA ZUNANJI OVOJNINI
119 10.
126 10.
120 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
127 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAK
121 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
128 PODATKI NA ZUNANJI OVOJNINI
14 x 1 orodispersible tablets 28 x 1 orodispersible tablets 49 x 1 orodispersible tablets
14 x 1 orodisperzibilna tableta 28 x 1 orodisperzibilna tableta 49 x 1 orodisperzibilna tableta
EU/ 1/ 04/ 276/ 024 14 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 025 28 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 026 49 x 1 orodispersible tablets
EU/ 1/ 04/ 276/ 024 14 x 1 orodisperzibilna tableta EU/ 1/ 04/ 276/ 025 28 x 1 orodisperzibilna tableta EU/ 1/ 04/ 276/ 026 49 x 1 orodisperzibilna tableta
123 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
130 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
124 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
131 PODATKI NA ZUNANJI OVOJNINI
125 9.
132 9.
EU/ 1/ 04/ 276/ 027 14 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 028 28 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 029 49 x 1 orodispersible tablets
EU/ 1/ 04/ 276/ 027 14 x 1 orodisperzibilna tableta EU/ 1/ 04/ 276/ 028 28 x 1 orodisperzibilna tableta EU/ 1/ 04/ 276/ 029 49 x 1 orodisperzibilna tableta
126 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
133 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
127 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
134 PODATKI NA ZUNANJI OVOJNINI
128 9.
135 9.
EU/ 1/ 04/ 276/ 030 14 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 031 28 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 032 49 x 1 orodispersible tablets
EU/ 1/ 04/ 276/ 030 14 x 1 orodisperzibilna tableta EU/ 1/ 04/ 276/ 031 28 x 1 orodisperzibilna tableta EU/ 1/ 04/ 276/ 032 49 x 1 orodisperzibilna tableta
129 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
136 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
130 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
137 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
ABILIFY 1 mg/ ml oral solution aripiprazole
ABILIFY 1 mg/ ml peroralna raztopina aripiprazol
Contains fructose, sucrose, E218, and E216.
Vsebuje fruktozo, saharozo, E218 in E216.
50 ml oral solution 150 ml oral solution 480 ml oral solution
50 ml peroralne raztopine 150 ml peroralne raztopine 480 ml peroralne raztopine
EXP Use within 6 months after first opening.
Porabite v 6 mesecih po prvem odprtju.
Hunton House Highbridge Business Park, Oxford Road Uxbridge - Middlesex UB8 1HU - United Kingdom
Hunton House Highbridge Business Park, Oxford Road Uxbridge - Middlesex UB8 1HU - Velika Britanija
EU/ 1/ 04/ 276/ 033 - 50 ml bottle EU/ 1/ 04/ 276/ 034 - 150 ml bottle EU/ 1/ 04/ 276/ 035 - 480 ml bottle
EU/ 1/ 04/ 276/ 033 - 50- ml plastenka EU/ 1/ 04/ 276/ 034 - 150- ml plastenka EU/ 1/ 04/ 276/ 035 - 480- ml plastenka
132 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
139 PODATKI NA ZUNANJI OVOJNINI
ABILIFY 7.5 mg/ ml solution for injection aripiprazole
ABILIFY 7, 5 mg/ ml raztopina za injiciranje aripiprazol
A vial provides 9.75 mg in 1.3 ml
Viala vsebuje 9, 75 mg v 1, 3 ml.
Also contains sulfobutylether b-cyclodextrin, tartaric acid, sodium hydroxide, and water for injection.
Vsebuje tudi sulfobutileter betaciklodekstrin, vinsko kislino, natrijev hidroksid in vodo za injekcije.
Solution for injection 1 vial
1 viala
Intramuscular use Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo.
133 10.
140 10.
MANUFACTURER’ S BATCH NUMBER
ŠTEVILKA SERIJE
As ABILIFY 7.5 mg/ ml solution for injection is only intended for administration by health care professionals, no information will be included in Braille.
Zdravilo ABILIFY 7, 5 mg/ ml raztopina za injiciranje bo uporabljalo le zdravstveno osebje, zato podatki v Braillovi pisavi ne bodo vključeni.
134 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
141 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA IN POT( I) UPORABE
ABILIFY 7.5 mg/ ml solution for injection aripiprazole Intramuscular use
ABILIFY 7, 5 mg/ ml raztopina za injiciranje aripiprazol Intramuskularna uporaba.
135 B.
142 B.
INFORMATION FOR THE USER
143 NAVODILO ZA UPORABO
What ABILIFY is and what it is used for 2.
Kaj je zdravilo ABILIFY in za kaj ga uporabljamo 2.
Before you take ABILIFY 3.
Kaj morate vedeti, preden boste vzeli zdravilo ABILIFY 3.
How to take ABILIFY 4.
Kako jemati zdravilo ABILIFY 4.
Possible side effects 5 How to store ABILIFY 6.
Shranjevanje zdravila ABILIFY 6.
WHAT ABILIFY IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ABILIFY IN ZA KAJ GA UPORABLJAMO
ABILIFY is one of a group of medicines called antipsychotics.
ABILIFY spada v skupino zdravil, imenovanih antipsihotiki.
It is used to treat adults who suffer from a disease characterised by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Uporablja se pri odraslih za zdravljenje bolezni s simptomi, kakršni so slišanje, videnje ali občutenje stvari, ki jih ni, sumničavost, zmotna prepričanja, nepovezano govorjenje in vedenje ter čustvena praznost.
ABILIFY is used to treat adults who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Zdravilo ABILIFY uporabljamo za zdravljenje odraslih, ki imajo težave s simptomi, kot so "privzdignjeno" razpoloženje, pretirana energija, zmanjšana potreba po spanju, hitro govorjenje s prehitevajočimi mislimi in občasno hujša razdražljivost.
It also prevents this condition from returning in patients who have responded to the treatment with ABILIFY.
Zdravilo tudi preprečuje ponovitve pri bolnikih, ki so se odzvali na zdravljenje z zdravilom ABILIFY.
BEFORE YOU TAKE ABILIFY
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ABILIFY
Do not take ABILIFY if you are allergic (hypersensitive) to aripiprazole or any of the other ingredients of ABILIFY.
Ne jemljite zdravila ABILIFY če ste alergični na (preobčutljivi za) aripiprazol ali katero koli sestavino zdravila ABILIFY.
Take special care with ABILIFY Before treatment with ABILIFY, tell your doctor if you suffer from High blood sugar or family history of diabetes Seizure Involuntary, irregular muscle movements, especially in the face Cardiovascular diseases, family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
Bodite posebno pozorni pri jemanju zdravila ABILIFY Pred začetkom zdravljenja z zdravilom ABILIFY morate obvestiti svojega zdravnika: če imate visok krvni sladkor ali sladkorno bolezen v družini, če imate napade krčev, če imate nehotne, neredne gibe mišic, zlasti na obrazu, če imate srčnožilne bolezni, srčnožilne bolezni v družini, možgansko kap ali "malo" kap, nenormalen krvni tlak.
If you notice you are gaining weight, experience any difficulty in swallowing or allergic symptoms, please tell your doctor.
Če opazite povečevanje telesne mase, težave s požiranjem ali znake alergije, o tem obvestite svojega zdravnika.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/ relative should tell your doctor if you have ever had a stroke or "mini" stroke.
Če ste starejša oseba in imate demenco (slabšanje spomina in drugih duševnih sposobnosti), morate vi ali vaš skrbnik/ sorodnik zdravniku povedati, če ste kdaj imeli možgansko kap ali "malo" kap.
137 Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
144 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.
Children and adolescents ABILIFY is not for use in children and adolescents as it has not been studied in patients under 18 years.
Otroci in mladostniki Zdravilo ABILIFY ni raziskano pri bolnikih, mlajših od 18 let, zato ni namenjeno za uporabo pri otrocih in mladostnikih.
Ask your doctor or pharmacist for advice before taking ABILIFY.
Pred uporabo zdravila ABILIFY vprašajte za nasvet zdravnika ali farmacevta.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.