natgillin/translations-raw huggingface dataset:
Weight gain is commonly seen in schizophrenic patients due to use of antipsychotics known to cause weight gain, co-morbidities, poorly managed life-style and might lead to severe complications. 
Povečanje telesne mase je pri bolnikih s shizofrenijo pogosto zaradi uporabe antipsihotikov, za katere je znano, da povzročajo povečanje mase, komorbidnih stanj, neurejenega življenjskega sloga in lahko vodi do hudih zapletov.
The results of analysis of the primary efficacy endpoint, the estimated proportion of patients experiencing impending relapse by end of Week 26 of the Double-blind, Active-controlled Phase, showed that Abilify Maintena 400 mg/300 mg is non-inferior to aripiprazole oral tablets 10-30 mg. 
Rezultati analize primarne končne točke učinkovitosti in ocenjeno razmerje bolnikov, pri katerih se do konca 26. tedna dvojno slepe aktivno nadzorovane faze pojavijo znaki bližnjega relapsa bolezni, kažejo, da je zdravilo Abilify Maintena 400 mg/300 mg neinferiorno zdravilu aripiprazol v 10-30 mg peroralnih tabletah.
If your baby develops any of these symptoms you need to contact your doctor. 
Če se pri vašem otroku pojavi kateri od teh simptomov, se posvetujte z zdravnikom.
Concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided for more than 14 days because the blood levels of aripiprazole are decreased and may be below the effective levels (see section 4.5). 
Sočasni uporabi močnih induktorjev CYP3A4 in zdravila Abilify Maintena več kot 14 dni se je treba izogibati, saj se raven aripiprazola v krvi zniža in lahko pade pod učinkovito raven (glejte poglavje 4.5).
Deltoid injections should be alternated between the two deltoid muscles. 
Injiciranje v deltoidno mišico je treba izmenjevati med obema deltoidnima mišicama.
These included: dose-dependent adrenocortical toxicity in rats after 104 weeks of oral administration at approximately 3 to 10 times the mean steady-state AUC at the maximum recommended human dose and increased adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas in female rats at approximately 10 times the mean steady-state AUC at the maximum recommended human dose. 
adrenokortikalni toksični učinki pri podganah, odvisni od odmerka, po 104 tednih oralnega odmerjanja od 3- do 10-kratne srednje AUC ob največjem priporočenem odmerku za človeka ter povečana pogostnost adrenokortikalnih karcinomov in kombiniranih adrenokortikalnih adenomov/karcinomov pri podganjih samicah ob odmerjanju približno 10-kratno srednjo AUC v stanju dinamičnega ravnovesja ob največjem priporočenem odmerku za človeka.
Step 2: Reconstitution of the powder a) Remove the solvent and powder vial caps and wipe the tops with a sterile alcohol swab. 
Korak 2: Rekonstitucija praška a) Odstranite pokrovček viale z vehiklom in viale s praškom ter vrhnje dele obrišite s sterilno alkoholno blazinico.
In a single-dose study with oral administration of aripiprazole, the pharmacokinetic characteristics of aripiprazole and dehydro-aripiprazole were found to be similar in patients with severe renal disease compared to that in young healthy subjects. 
Ledvična okvara Študija z enim samim odmerkom oralnega aripiprazola kaže, da so farmakokinetične lastnosti aripiprazola in dehidroaripiprazola pri bolnikih s hudo boleznijo ledvic podobne kot pri mladih zdravih preiskovancih.
Receiving Abilify Maintena with some medicines may mean the doctor will need to change your dose of Abilify Maintena or the other medicines. 
Pri jemanju zdravila Abilify Maintena skupaj z nekaterimi drugimi zdravili bo morda treba spremeniti odmerek zdravila Abilify Maintena.
One vial of powder 
Ena viala s praškom
With intramuscular injection, however an inflammatory response was seen at the injection site, and consisted of granulomatous inflammation, foci (deposited drug), cellular infiltrates, oedema (swelling) and, in monkeys, fibrosis. 
Pri intramuskularnem injiciranju so opazili vnetno reakcijo na mestu injiciranja, ki je vključevala granulomatozno vnetje, žarišča (ostanke zdravila), celične infiltrate, edem (oteklino) in fibrozo pri opicah.
A number of symptoms of dystonia are then listed, including spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. 
Nato so navedeni številni simptomi distonije, vključno s krčem vratnih mišic, ki včasih napreduje v stiskanje žrela, težave pri požiranju, težave z dihanjem in/ali protruzijo jezika.
However, in one of these trials, a fixed-dose trial, there was a significant doseresponse 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 prejemali aripiprazol, za cerebrovaskularne neželene učinke obstajal pomemben odnos med odmerkom in odzivom (glejte poglavje 4.8).
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), rash 
• alergijska reakcija (npr. oteklost ust, jezika, obraza in žrela, srbenje, koprivnica), izpuščaj,
Step 1: Preparation prior to reconstitution of the powder Lay out and confirm that components listed below are provided: - Abilify Maintena package leaflet and instructions for healthcare professionals. 
Korak 1: Priprava pred rekonstitucijo praška Pripravite komponente in preverite, ali so prisotne vse naslednje: - navodila za uporabo zdravila Abilify Maintena in navodila za zdravstveno osebje, - viala s praškom, - viala z vehiklom 2 ml,
Proportion of subjects free of impending relapse 
Delež oseb brez tveganja za pojav skorajšnjega relapsa
The safety profile was consistent with that known to Abilify Maintena. 
Varnostni profil ustreza že znanemu profilu za zdravilo Abilify Maintena.
• thirstiness more than usual, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick, feel confused or your breath smells fruity, since this may be a sign of diabetes. 
• močnejšo žejo kot običajno, močnejšo potreba po uriniranju kot običajno, občutek močne lakote, občutek šibkosti ali utrujenosti, občutek slabosti, občutek zmedenosti ali zadah z vonjem po sadju, saj je to lahko znak sladkorne bolezni.
Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reduction should, therefore, be applied (see section 4.2). 
Pričakovati je mogoče, da imajo drugi močni zaviralci CYP2D6, npr. fluoksetin in paroksetin, podobne učinke, zato je treba odmerek zmanjšati v podobni meri (glejte poglavje 4.2).
The estimated relapse rate by end of Week 26 was 7.12 % for Abilify Maintena, and 7.76 % for oral aripiprazole tablets 10-30 mg, a difference of -0.64 %. 
Ocenjena stopnja relapsa bolezni do konca 26. tedna je bila 7,12 % pri zdravilu Abilify Maintena, in 7,76 % pri aripiprazolu v 10-30 mg peroralnih tabletah, z razliko −0,64 %.
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). 
Pričakovati je mogoče, da imajo drugi močni zaviralci CYP3A4, npr. itrakonazol in zaviralci proteaz HIV, podobne učinke, zato je treba odmerke zmanjšati v podobni meri (glejte poglavje 4.2).
If you are given more Abilify Maintena than you should 
Če ste dobili večji odmerek zdravila Abilify Maintena, kot bi smeli
- The active substance is aripiprazole. 
- Zdravilna učinkovina je aripiprazol.
• blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots 
• krvne strdke ali težave s krvnimi strdki v družini; antipsihotike namreč povezujejo z nastajanjem krvnih strdkov,
Pull e) Hold syringe upright and advance plunger rod slowly to expel the air. 
Povlecite e) Injekcijsko brizgo držite pokonci in počasi pritiskajte na potiskalo bata, da iztisnete zrak.
Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. 
Vialo močno stresajte vsaj 30 sekund, dokler suspenzija ni homogena.
The incidence of weight gain of ≥ 7 % from baseline to last visit (week 12) was 21.5 % for Abilify Maintena compared with the placebo group 8.5 %. 
Pojavnost povečanja telesne mase za ≥ 7 % od izhodišča do zadnjega obiska (12. teden) je znašala 21,5 % za zdravilo Abilify Maintena v primerjavi z 8,5 % za placebo.
Step 3: Preparation prior to injection a) Remove the cover, but not the adapter from the package. 
Korak 3: Priprava pred injiciranjem a) S škatle odstranimo pokrov, nastavek pa pustimo v škatli.
Thus, superiority of Abilify Maintena over the aripiprazole Long-Acting Injectable 50 mg/25 mg was established and the validity of the trial design was confirmed. 
Posledično je bila ugotovljena superiornost zdravila Abilify Maintena v primerjavi z dolgodelujočim parantertalnim aripiprazolom 50 mg/25 mg in s tem potrjena veljavnost načrta preskušanja.
Gluteal injections should be alternated between the two gluteal muscles. 
Injiciranje v glutealno mišico je treba izmenjevati med obema glutealnima mišicama.
Care must be taken to avoid inadvertent injection into the blood vessel. 
Potrebna je previdnost, da ne pride do nenamernega injiciranja v krvno žilo.
Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) 
(vključno s pljučno embolijo in globoko vensko trombozo)
• grinding of teeth or clenching of the jaw 
• škrtanje z zobmi ali stiskanje čeljusti,
• low level of a specific type of white blood cells (neutropenia), low haemoglobin or red blood cell count, low level of blood platelets 
• nizka raven specifičnih belih krvničk (nevtropenija), nizka raven hemoglobina ali nizka raven rdečih krvničk, nizka raven trombocitov,
You should not be given Abilify Maintena if you are pregnant unless you have discussed this with your doctor. 
Če ste noseči, vam ne smejo dajati zdravila Abilify Maintena, razen če ste se tako dogovorili z zdravnikom.
Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. 
Učinek zdravil iz te skupine (»Class Effect«): v prvih nekaj dneh zdravljenja se lahko pri dovzetnih posameznikih pojavijo simptomi distonije, podaljšanega nenormalnega krčenja mišičnih skupin.
Abilify Maintena should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted. 
Zdravila Abilify Maintena ne smemo uporabljati, kadar je potreben takojšen nadzor simptomov pri akutno agitiranih ali zelo psihotičnih bolnikih.
Close supervision of high risk patients should accompany antipsychotic treatment. 
Med antipsihotičnim zdravljenjem je treba bolnike z visokim tveganjem skrbno nadzirati.
Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with aripiprazole. 
V nekaterih primerih je bila hiperglikemija zelo izrazita in povezana s ketoacidozo ali hiperosmolarno komo ali smrtjo.
If there are adverse reactions with the 400 mg dosage, reduction of the dose to 300 mg once monthly should be considered. 
Če so s 400 mg odmerkom povezane neželene reakcije, je treba razmisliti o zmanjšanju odmerka na
i) Do not store the reconstituted suspension in the syringe. 
i) Rekonstituirane suspenzije ne shranjujte v injekcijski brizgi.
• enlargement of breast in men, breast tenderness, vaginal dryness 
• povečanje prsi pri moških, občutljivost dojk, suhost nožnice,
In a short-term (12-week), randomised, double-blind, placebo-controlled trial with Abilify Maintena 400 mg/300 mg treated subjects the symptoms which had at least twice the incidence of placebo were increased weight and akathisia. 
(12-tedenskem), randomiziranem, dvojno slepem, s placebom nadzorovanem preskušanju so pri preiskovancih, zdravljenih z zdravilom Abilify Maintena 400 mg/300 mg, opazili simptoma povečane telesne mase in akatizije, za katera je bila značilna vsaj dvakrat večja pojavnost v primerjavi s placebom.
b) Using the syringe with pre-attached needle, withdraw the pre-determined solvent volume from the vial of the solvent into the syringe. 
b) Z injekcijsko brizgo s predhodno pritrjeno iglo izvlecite predhodno določeno količino vehikla iz viale v injekcijsko brizgo.
In clinical trials of treatment with oral aripiprazole, the incidence of QT prolongation was comparable to placebo. 
V kliničnih preskušanjih peroralnega aripiprazola je bila pojavnost podaljšanja intervala QT
Add 1.5 ml solvent to reconstitute the powder. 
Dodajte 1,5 ml vehikla, da rekonstituirate prašek.
Remember to rotate sites of injections between the two gluteal or deltoid muscles. 
Ne pozabite izmenjavati mesta injiciranja med obema glutealnima ali deltoidnima mišicama.
Similarly, there was no clinically relevant effect of gender in a population pharmacokinetic analysis of Abilify Maintena in clinical trials in patients with schizophrenia. 
Prav tako med spoloma ni bilo opaznih razlik v populacijski farmakokinetični analizi zdravila Abilify Maintena v kliničnih preskušanjih pri shizofrenih bolnikih.
If you see more than one doctor, be sure to tell them that you are receiving Abilify Maintena. 
Če obiskujete več zdravnikov, jih morate seznaniti s tem, da prejemate zdravilo Abilify
• jerky resistance to passive movement as muscles tense and relax, abnormally increased muscle tone, slow body movement 
• sunkovit upor pri pasivnih gibih, ko se mišice napenjajo in sproščajo, nenormalno povečanje napetosti mišic, počasno gibanje telesa,
• increased levels of insulin, a hormone regulating blood sugar levels 
• povišana raven hormona inzulina, ki uravnava sladkor v krvi,
After oral administration of aripiprazole, there are no differences in the pharmacokinetics of aripiprazole between healthy elderly and younger adult subjects. 
Po oralnem odmerku aripiprazola se farmakokinetika aripiprazola med zdravimi starejšimi in mlajšimi odraslimi preiskovanci ne razlikuje.
This trial consisted of a screening phase and 4 treatment phases: Conversion, Oral Stabilisation, Abilify Maintena Stabilisation, and Double-blind Placebo-controlled. 
To preskušanje so sestavljale presejalna faza in štiri faze zdravljenja: faza prehoda, faza peroralne stabilizacije, faza stabilizacije z zdravilom Abilify Maintena in dvojno slepa s placebom nadzorovana faza.
• swelling of hands, ankles or feet 
• zatekanje rok, gležnjev ali stopal,
Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. 
Zdravilo Abilify Maintena je indicirano za vzdrževalno zdravljenje shizofrenije pri odraslih bolnikih, stabiliziranih s peroralnim aripiprazolom.
Dose adjustments due to interactions with CYP2D6 and/or CYP3A4 inhibitors and/or CYP3A4 inducers 
Prilagajanje odmerka zaradi medsebojnega delovanja z zaviralci CYP2D6 in/ali CYP3A4 in/ali induktorji CYP3A4
The reconstituted suspension should be used immediately but may be stored below 25°C for up to 4 hours in the vial. 
Rekonstituirano suspenzijo je treba uporabiti takoj po rekonstituciji, vendar jo lahko za največ 4 ure shranite v viali pri temperaturi nižji od 25 °C.
• changes in your level of alertness, drowsiness 
• spremembe stanja zavesti, zaspanost,
It is important that you carry on receiving Abilify Maintena for as long as your doctor has told you to. 
Abilify Maintena nadaljujete tako dolgo, kot vam je svetoval zdravnik.
The SmPC for Abilify Maintena prolonged-release suspension for injection lists oculogyric crisis in section 4.8 and the PIL lists fixation of eye balls in one position as an uncommon side effect. 
Povzetek glavnih značilnosti zdravila Abilify Maintena suspenzija za injiciranje s podaljšanim sproščanjem okulogirno krizo navaja v poglavju 4.8, Navodilo za uporabo pa navaja fiksiranje očesnih zrkel kot občasni neželeni učinek.
• accidental inhalation of food with risk of pneumonia (lung infection) 
• krči mišic v grlu, • naključno vdihanje hrane s tveganjem za pljučnico (okužba pljuč),
Aripiprazole oral 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 peroralnega aripiprazola enkrat na dan pri zdravih preiskovancih povzročila od odmerka odvisno zmanjšanje vezave 11C-rakloprida, liganda receptorjev D2/D3, v nucleusu caudatusu in putamnu.
Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised during treatment with oral aripiprazole. 
Zdravilo Abilify Maintena je namenjeno odraslim bolnikom s shizofrenijo, ki so bili med zdravljenjem s peroralno obliko aripiprazola ustrezno stabilizirani.
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection EU/1/13/882/001 
Abilify Maintena 300 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem EU/1/13/882/001
Body type 
Telesna masa
Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalysed by CYP3A4. 
Na podlagi raziskav in vitro dehidrogenacijo in hidroksilacijo aripiprazola povzročajo encimi CYP3A4 in CYP2D6, N-dealkilacijo pa katalizira CYP3A4.
20 seconds c) Visually inspect the syringe for particulate matter and discoloration prior to administration. 
20 sekund c) Rekonstituirano suspenzijo pred dajanjem preglejte za delci in obarvanjem.
• sensitivity to light 
• izpuščaj, • občutljivost kože za svetlobo,
• a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness since this may be a sign of a condition called neuroleptic malignant syndrome (NMS). 
• kombinacijo zvišane telesne temperature, hitrega dihanja, znojenja, togosti mišic, zmanjšane stopnje zavesti ali zaspanosti, saj je to lahko znak stanja, ki se imenuje maligni nevroleptični sindrom (MNS);
Patients eligible for the Double-blind, Placebo-controlled Phase were randomly assigned in a 2:1 ratio to double-blind treatment with Abilify Maintena or placebo, respectively. 
Bolniki, ki so bili primerni za vključitev v dvojno slepo s placebom nadzorovano fazo, so bili v razmerju 2 : 1 randozimirano porazdeljeni v skupino, ki je prejemala dvojno slepo zdravljenje z zdravilom Abilify Maintena, ali skupino, ki je prejemala dvojno slepo zdravljenje s placebom.
In clinical trials and post-marketing experience, accidental or intentional acute overdose of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg (41 times highest recommended daily aripiprazole dose) with no fatalities. 
V kliničnih preskušanjih in iz izkušenj v obdobju trženja so ugotovili naključno ali namerno akutno preveliko odmerjanje aripiprazola samega pri odraslih bolnikih z ocenjenimi odmerki do 1.260 mg
• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital) 
• antikonvulzivi, ki se uporabljajo za zdravljenje epilepsije (kot so karbamazepin, fenitoin, fenobarbital),
Clear glass pre-filled syringe (type-I glass) with grey chlorobutyl stoppers (front-, middle- and end stopper), polypropylene front assembly, polypropylene finger grip, plunger rod, and silicone over-cap. 
Napolnjena injekcijska brizga iz prozornega stekla (steklo tipa I) s sivimi klorobutilnimi zamaški (sprednji, srednji in končni zamašek), polipropilenskim sprednjim sklopom, polipropilenskim oprijemom, potiskalom bata in silikonskim pokrovčkom.
• muscle problems 
• težave z mišicami,
Shelf-life after reconstitution: 4 hours below 25 °C Do not store the reconstituted suspension in the syringe. 
Rok uporabnosti po rekonstituciji: 4 ure pri temperaturi do 25 °C Rekonstituirane suspenzije ne shranjujte v injekcijski brizgi.
No dosage adjustment is required for patients with mild or moderate hepatic impairment. 
Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati.
Your doctor will give it to you as a single injection into the gluteal or deltoid muscle (buttock or shoulder) every month. 
Zdravnik vam bo zdravilo vsak mesec dal v obliki ene injekcijo v glutealno ali deltoidno mišico
• prolonged and/or painful erection 
• simptomi odtegnitve zdravila pri novorojenčku, • dolgotrajna in/ali boleča erekcija,
If it's not possible to advance plunger rod to expel the air, check that plunger rod is rotated to a complete stop. 
Če potiskala bata ni več mogoče potisniti naprej in iztisniti zraka, se prepričajte, ali potiskala bata ni mogoče več obračati.
Therefore, Abilify Maintena is non-inferior to aripiprazole oral tablets 10-30 mg. 
Zato je zdravilo Abilify Maintena neinferiorno zdravilu aripiprazol v 10-30 mg peroralnih tabletah.
Parkinsonism events followed in frequency of 6.9 % for Abilify Maintena, 4.15 % for oral aripiprazole 10-30 mg tablets and 3.0 % for placebo, respectively. 
Sledili so dogodki parkinsonizma, in sicer z naslednjo pogostnostjo: 6,9 % pri zdravilu Abilify Maintena, 4,15 % pri aripiprazolu v 10-30 mg peroralnih tabletah in 3,0 % pri placebu.
In a clinical trial of oral aripiprazole in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63 % and 37 %, respectively. 
V kliničnem preskušanju peroralnega aripiprazola pri zdravih preiskovancih je močan zaviralec CYP3A4 (ketokonazol) zvečal AUC aripiprazola za 63 %, njegov Cmax pa za 37 %.
The incidences of Abilify Maintena patients with prolactin levels > 1 time the upper limit of normal range (ULN) was 1.9 % compared to 7.1 % for placebo patients. 
Pojavnost bolnikov, zdravljenih z zdravilom Abilify Maintena in ravnmi prolaktina z > 1-kratno zgornjo mejo normalnih vrednosti (ULN), je znašala 1,9 % v primerjavi s 7,1 % bolnikov, ki so prejemali placebo.
Abilify Maintena 400 mg Vial 
Abilify Maintena 400 mg viala
*If there's resistance or difficulty expelling air, check that plunger rod is rotated to a complete stop. 
*Če začutite upor ali imate pri iztisu zraka težave, se prepričajte, da potiskala bata ni mogoče več obračati.
* 200 mg and 160 mg can be achieved via adjustment of the injection volume only by using Abilify Maintena powder and solvent for prolonged-release suspension for injection. 
* Prilagoditev odmerka na 200 mg in 160 mg je mogoča samo z uporabo zdravila Abilify Maintena prašek in vehikel za suspenzijo za injiciranje s podaljašnim sproščanjem.
The incidence of Abilify Maintena patients with prolactin levels > 1 time the upper limit of normal range (ULN) at any assessment was 5.4 % compared with 3.5 % of the patients on oral aripiprazole tablets 10-30 mg. 
Pojavnost bolnikov, zdravljenih z zdravilom Abilify Maintena in ravnmi prolaktina z > 1-kratno zgornjo mejo normalnih vrednosti (ULN), je po vseh ocenah znašala 5,4 %, v primerjavi s 3,5 % pri bolnikih, ki so prejemali aripiprazol v 10-30 mg peroralnih tabletah.
Male patients generally had a higher incidence than female patients in each treatment group. 
V posamezni preiskovani skupini je bila pojavnost v splošnem višja pri bolnikih kot pri bolnicah.
Quinidine and other strong CYP2D6 inhibitors 
Kinidin in drugi močni zaviralci CYP2D6
Non-clinical safety data for orally administered aripiprazole 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 za peroralno odmerjen aripiprazol na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja in razvoja niso pokazali posebnega tveganja za človeka.
Excess amount of gastric juice flowing back (refluxes) into the esophagus (gullet or the tube that goes from mouth to stomach through which food passes), 
Prekomerna količina želodčnega soka (refluksi) v požiralniku (požiralnik ali cev, ki gre iz ust v želodec, skozi katero potuje hrana), ki povzroča zgago in lahko poškoduje požiralnik.
Step 3: Injection procedure a) Twist and pull off Over-cap and Tip-cap. 
Korak 3: Postopek injiciranja a) Obrnite in snemite zunanji pokrov ter pokrovček konice.