natgillin/translations-raw huggingface dataset:
• blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately),
• krvni strdki v venah, zlasti v venah nog (simptomi vključujejo oteklino, bolečino in rdečino noge), ki lahko potujejo po krvnih žilah v pljuča in povzročijo bolečino v prsih in težave z dihanjem (če opazite katerega od navedenih simptomov, takoj poiščite zdravniško pomoč),
Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Ker je orodisperzibilna tableta krhka, jo mora bolnik vzeti takoj, ko odpre pretisni omot.
The information below is obtained from studies with oral aripiprazole.
Spodnji podatki so pridobljeni iz študij s peroralnim aripiprazolom.
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 hitro razpadejo.
The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:
O naslednjih neželenih učinkih so poročali v obdobju od prihoda peroralnega aripiprazola na trg; pogostnost pojavljanja le-teh pa ni znana:
Simultaneous administration of injectable antipsychotics and parenteral benzodiazepine may be associated with excessive sedation and cardiorespiratory depression.
Sočasno dajanje antipsihotikov za injiciranje in parenteralnih benzodiazepinov je lahko povezano z močno sedacijo in kardiorespiratorno depresijo.
In adults it also prevents this condition from returning in patients who have responded to the treatment with ABILIFY.
Zdravilo tudi preprečuje ponovitve bolezni pri odraslih bolnikih, ki so se odzvali na zdravljenje z zdravilom ABILIFY.
Orodispersible tablets or oral solution may be used as an alternative to ABILIFY tablets for patients who have difficulty swallowing ABILIFY tablets (see section 5.2).
Orodisperzibilne tablete ali peroralna raztopina se lahko uporabijo kot alternativa tabletam ABILIFY pri bolnikih, ki tablete ABILIFY težko pogoltnejo (glejte poglavje 5.2).
Caution should be taken when treating patients at higher risk, and a lower starting dose should be considered (e.g., elderly or debilitated patients; see section 4.2).
Pri zdravljenju bolnikov z večjim tveganjem je potrebna previdnost, zato je treba razmisliti o nižjem začetnem odmerku (npr. pri starejših ali oslabljenih bolnikih; glejte poglavje 4.2).
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 with no fatalities.
V kliničnih preskušanjih in obdobju pomarketinških izkušenj so ugotovili naključno ali namerno preveliko odmerjanje aripiprazola samega pri odraslih bolnikih z ocenjenimi odmerki do 1.260 mg brez smrtnih primerov.
• The active substance is aripiprazole.
• Učinkovina je aripiprazol.
This medicine contains 200 mg of fructose and 400 mg of sucrose in each mL.
To zdravilo vsebuje 200 mg fruktoze in 400 mg saharoze na mililiter.
• increased diastolic blood pressure,
• zvišan diastolični krvni tlak,
Therefore, ABILIFY is not recommended for use in patients below 13 years of age (see sections 4.8 and 5.1).
Uporabe zdravila ABILIFY se zato pri bolnikih, mlajših od 13 let, ne priporoča (glejte poglavji 4.8 in 5.1).
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,
• serotoninski sindrom (reakcija, ki lahko povzroči močan občutek sreče, omotico, okornost,
Urinary incontinence Urinary retention
Bolezni sečil urinska inkontinenca retencija urina
Patients were 6 to 18 years and presented an average score of 29 on TTS-YGTSS at baseline.
Bolniki so bili stari od 6 do 18 let, njihov povprečni izhodiščni rezultat na lestvici TTS-YGTSS pa je bil 29.
Contains fructose, sucrose, E218, and E216.
Vsebuje fruktozo, saharozo, E 218 in E 216.
Extrapyramidal symptoms were mainly reported during the stabilisation phase in 17 % of patients, with tremor accounting for 6.5 %.
O ekstrapiramidnih simptomih so poročali predvsem med stabilizacijsko fazo, in sicer pri 17 % bolnikov, od tega je 6,5 %
The total dose of ABILIFY (all formulations) should not exceed 30 mg per day.
Skupni odmerek zdravila ABILIFY (vse farmacevtske oblike) ne sme preseči 30 mg na dan.
Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking aripiprazole.
Pri bolnikih se lahko poveča impulzivnost, zlasti želja po igrah na srečo, med jemanjem aripiprazola pa teh niso več sposobni nadzorovati.
Solution for injection 1 vial
Raztopina za injiciranje 1 viala
What ABILIFY is and what it is used for
Kaj je zdravilo ABILIFY in za kaj ga uporabljamo
Treatment with ABILIFY solution for injection should be discontinued as soon as clinically appropriate and the use of oral aripiprazole should be initiated.
Zdravljenje z zdravilom ABILIFY raztopina za injiciranje je treba prekiniti takoj, ko je to klinično primerno, in uvesti zdravljenje s peroralnimi oblikami aripiprazola.
To enhance absorption and minimise variability, injection into the deltoid or deep within the gluteus maximus muscle, avoiding adipose regions, is recommended.
Zaradi hitrejše absorpcije in zmanjšanja variabilnosti priporočamo injiciranje v deltoidno mišico ali globoko v veliko glutealno mišico, pri čemer se je treba izogibati adipoznih področij.
ABILIFY is used to treat quickly symptoms of agitation and distressing behaviour that may occur in a disease characterised by symptoms such as:
Zdravilo ABILIFY uporabljamo za hitro zdravljenje simptomov agitacije in vedenjskih sprememb, ki se lahko pojavijo pri bolezni, za katero so značilni simptomi, kot so:
However, the estimation of the HR for the younger (13 to 14 years) group was not precise, reflecting the smaller number of subjects in that group (aripiprazole, n = 29; placebo, n = 12), and the confidence interval for this estimation (ranging from 0.151 to 1.628) did not allow conclusions to be drawn on the presence of a treatment effect.
Vendar pa ocena razmerja ogroženosti pri skupini mlajših mladostnikov (13 do 14 let) ni bila točna zaradi manjšega števila preskušancev v tej skupini (aripiprazol, n = 29; placebo, n = 12), interval zaupanja za to oceno (ki je od 0,151 do 1,628)
It is not known if it is safe and effective in these patients.
Varnost in učinkovitost tega zdravila pri teh bolnikih nista znana.
Following any confirmed or suspected accidental overdose/inadvertent intravenous administration, close observation of the patient is needed and if any potentially medically serious sign or symptom develops, monitoring, which should include continuous electrocardiographic monitoring, is required.
Po vsakem potrjenem ali domnevno nenamernem prevelikem odmerjanju/nenamernem intravenskem dajanju zdravila, je potreben skrben zdravniški nadzor in, če se razvijejo morebitni zdravstveno resni znaki ali simptomi, je zahtevano spremljanje, ki mora vključevati elektrokardiografsko spremljanje.
After a 13 to 26-week stabilisation on aripiprazole (2 mg/day to 15 mg/day) patients with a stable response were either maintained on aripiprazole or substituted to placebo for further 16 weeks.
Po 13 do 26 tednih stabilizacije na aripiprazolu (2 mg/dan do 15 mg/dan) so bolniki s stabilnim odzivom nadaljnjih 16 tednov bodisi ostali na aripiprazolu ali pa so prešli na placebo.
Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3 to 5 hours after dosing.
Aripiprazol se dobro absorbira in doseže največjo koncentracijo v plazmi v 3 do 5 urah po uporabi.
In contrast the 95 % confidence interval for the HR in the older subgroup (aripiprazole, n = 69; placebo, n = 36) was 0.242 to 0.879 and hence a treatment effect could be concluded in the older patients.
V nasprotju s tem je bil 95-% interval zapanja za RO pri starejši podskupini (aripiprazol, n = 69; placebo, n = 36) od 0,242 do 0,879, tako da je pri starejših bolnikih mogoče sprejeti zaključek o učinkovitosti zdravljenja.
Removal of the intact orodispersible tablet from the mouth is difficult.
Orodisperzibilno tableto je iz ust težko vzeti nedotaknjeno.
In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56 to 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.
V treh s placebom nadzorovanih preskušanjih (n = 938, povprečna starost: 82,4 leta, razpon: 56 do 99 let) aripiprazola pri starejših bolnikih s psihozo, povezano z Alzheimerjevo boleznijo, je bilo tveganje smrti večje pri bolnikih, ki so dobivali aripiprazol, kot pri tistih, ki so dobivali placebo.
Patients treated with any antipsychotics, including aripiprazole, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control (see section 4.8).
Bolnike, ki dobivajo kateri koli antipsihotik, vključno z aripiprazolom, je treba opazovati glede znakov in simptomov hiperglikemije (npr. polidipsije, poliurije, polifagije in šibkosti); bolnike z diabetesom mellitusom ali dejavniki tveganja zanj pa je treba redno nadzirati, da bi odkrili poslabšanje urejenosti glukoze (glejte poglavje 4.8).
It can be taken with or without liquid.
Vzeti jih je mogoče s tekočino ali brez nje.
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.
Klinična pomembnost rezultatov za učinkovitost v obeh kratkih preskušanjih ni bila ugotovljena, zaradi magnitude učinka zdravila v primerjavi z velikim učinkom placeba in nejasnega vpliva na psihosocialno delovanje.
Aripiprazole has minor to moderate influence on the ability to drive and use machines due to potential nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia (see section 4.8).
Aripiprazol ima blag do zmeren vpliv na sposobnost vožnje in upravljanje s stroji zaradi morebitnega vpliva na živčni sistem in vid, kot je sedacija, somnolenca, sinkopa, zamegljen vid in diplopija (glejte poglavje 4.8).
The maximum daily dose of aripiprazole is 30 mg (including all formulations of ABILIFY).
Največji dnevni odmerek aripiprazola je 30 mg (vključno z vsemi ostalimi farmacevtskimi oblikami zdravila ABILIFY).
Other medicines and ABILIFY
Druga zdravila in zdravilo ABILIFY
Contents of the pack and other information What ABILIFY contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo ABILIFY
For single tablet removal, open the package and peel back the foil on the blister to expose the tablet.
Da boste iz omota vzeli eno samo tableto, odprite pakiranje in s pretisnega omota potegnite folijo, da boste razkrili tableto.
• reports of abnormal liver tests values,
• primeri nenormalnih izvidov laboratorijskih jetrnih preiskav,
Among the patients included in the primary efficacy analysis, 139 patients had a current co-morbid diagnosis of ADHD.
Izmed bolnikov, ki so bili vključeni v primarno analizo učinkovitosti, je imelo 139 bolnikov sočasno tudi diagnozo motnje pomanjkanja pozornosti (ADHD - Attention deficit hyperactivity disorder).
If you realise you have taken more ABILIFY than your doctor has recommended (or if someone else has taken some of your ABILIFY), contact your doctor right away.
Če ste vzeli večji odmerek zdravila ABILIFY, kot bi smeli Če ugotovite, da ste vzeli več zdravila ABILIFY, kot vam je priporočil zdravnik (ali če je vaše zdravilo ABILIFY vzel kdo drug), se takoj posvetujte s svojim zdravnikom.
Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 L/kg, indicating extensive extravascular distribution.
Aripiprazol se obsežno porazdeli po telesu in ima navidezni volumen porazdelitve 4,9 l/kg, kar kaže na izdatno zunajžilno porazdelitev.
Outer carton:
Zunanja ovojnina:
• selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
• selektivne zaviralce privzema serotonina (SSRI) (kot sta paroksetin in fluoksetin) uporabljamo za depresijo, OCD, paniko in anksioznost,
Excipients with known effect (per mL)
Pomožna(e) snov(i) z znanim učinkom (na ml):
If parenteral benzodiazepine therapy is deemed necessary in addition to aripiprazole solution for injection, patients should be monitored for excessive sedation and for orthostatic hypotension (see section 4.5).
Če se presodi, da je poleg aripiprazola v obliki raztopine za injiciranje potrebno tudi zdravljenje s parenteralnimi benzodiazepini, je treba bolnike nadzirati glede prekomerne sedacije in ortostatske hipotenzije (glejte poglavje 4.5).
Patients receiving ABILIFY solution for injection should be observed for orthostatic hypotension.
Bolnike, ki prejemajo zdravila ABILIFY raztopina za injiciranje, je treba nadzirati glede ortostatske hipotenzije.
• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
• pojav sladkorne bolezni (diabetesa) ali njeno poslabšanje, ketoacidoza (ketoni v krvi in urinu)
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
• alergijska reakcija (npr. oteklost ust, jezika, obraza in žrela, srbenje, izpuščaj),
ABILIFY contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
Zdravilo ABILIFY vsebuje učinkovino aripiprazol in spada v skupino zdravil, imenovanih antipsihotiki.
It may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Lahko škoduje ljudem, ki imajo fenilketonurijo, redko genetsko bolezen, pri kateri pride do kopičenja fenilalanina, ker se ne more ustrezno odstranjevati iz telesa.
Actual scores in rating scales used as secondary endpoints, including PANSS and the Montgomery-Åsberg Depression Rating Scale (MADRS) showed a significant improvement over haloperidol.
Dejanske ocene po ocenjevalnih lestvicah (vključno s PANSS in lestvico Montgomery-Åsberg Depression Rating Scale [MADRS]), ki so predstavljale sekundarne končne točke, so pokazale značilno izboljšanje v primerjavi s haloperidolom.
The European Medicines Agency has deferred the obligation to submit the results of studies with ABILIFY in one or more subsets of the paediatric population in the treatment of schizophrenia and in the treatment of bipolar affective disorder (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom ABILIFY za eno ali več podskupin pediatrične populacije pri zdravljenju shizofrenije in bipolarne afektivne motnje (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.
• okorelost mišic in omotičnost ali zaspanost, upočasnjeno dihanje, dušenje, visok ali nizek krvni tlak, motnje srčnega ritma.
The rate of death in aripiprazoletreated patients was 3.5 % compared to 1.7 % in the placebo group.
Delež smrti je bil v skupini z aripiprazolom 3,5 % in v skupini s placebom 1,7 %.
If continued treatment is indicated with oral aripiprazole, see the Summary of Product Characteristics for ABILIFY tablets, ABILIFY orodispersible tablets, or ABILIFY oral solution.
Če je indicirano nadaljevanje zdravljenja s peroralnimi oblikami aripiprazola, glejte povzetke glavnih značilnosti zdravila za zdravila ABILIFY tablete, ABILIFY orodisperzibilne tablete ali ABILIFY
Sudden death unexplained Torsades de pointes Ventricular arrhythmia Cardiac arrest Bradycardia
Srčne bolezni tahikardija nenadna nepojasnjena smrt torsades de pointes ventrikularna aritmija zastoj srca bradikardija
Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.
Aripiprazol deluje antagonistično na adrenergične receptorje α1, zato lahko stopnjuje učinek nekaterih antihipertenzivnih zdravil.
Aripiprazole/metabolites are excreted in human milk.
Aripiprazol/presnovki se izločajo v materino mleko.
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.
Učinkovitost aripiprazola pri shizofreniji in bipolarni motnji I je domnevno posledica kombinacije delnega agonizma na dopaminskih receptorjih D2 in serotoninskih receptorjih 5-HT1A ter antagonizma na serotoninskih receptorjih 5-HT2A.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo jemati tega zdravila.
The dose of ABILIFY must be measured using the calibrated cup or the 2 mL calibrated dropping pipette supplied in the carton.
Odmerek zdravila ABILIFY morate odmeriti z umerjeno odmerno čašo ali umerjeno 2 ml kapalko, ki sta priloženi v škatli.
The safety profile of a long-term, double-blind, placebo-controlled trial was also similar except for the following reactions that were reported more frequently than paediatric patients taking placebo: weight decreased, blood insulin increased, arrhythmia, and leukopenia were reported commonly (≥ 1/100,
Profil varnosti v dolgotrajnem dvojnoslepem, s placebom nadzorovanem kliničnem preskušanju je bil prav tako podoben, razen pri naslednjih reakcijah, o katerih so poročali pogosteje pri pediatričnih bolnikih, ki so jemali placebo: pogosto so navajali zmanjšanje telesne mase, zvišano vrednost inzulina v krvi, aritmijo in levkopenijo (≥ 1/100, < 1/10).
In a 60- to 89-week, randomised, double-blind, placebo-controlled trial in adolescent subjects (n = 146; ages 13 to 17 years) with schizophrenia, there was a statistically significant difference in the rate of relapse of psychotic symptoms between the aripiprazole (19.39 %) and placebo (37.50 %) groups.
V 60- do 89-tedenskem, randomiziranem, dvojnoslepem, s placebom kontroliranem preskušanju pri mladostnikih s shizofrenijo (n = 146; v starosti od 13 do 17 let) je bilo opaziti statistično značilno razliko v stopnji ponovitve psihotičnih simptomov med skupinama bolnikov, zdravljenih z aripiprazolom (19,39 %) in s placebom (37,50 %).
The safety and efficacy of ABILIFY solution for injection in children and adolescents aged 0 to 17 years have not been established.
Varnost in učinkovitost zdravila ABILIFY pri otrocih in mladostnikih, starih od 0 do 17 let, še nista bili dokazani.
Outer carton: abilify 1 mg/mL
Zunanja ovojnina: abilify 1 mg/ml
Gender No dosage adjustment is required for female patients as compared to male patients (see section 5.2).
Pri bolnicah v primerjavi z bolniki odmerka ni treba prilagajati (glejte poglavje 5.2).
• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
• akutno zmedenost, krče (epilepsijo), komo, kombinacijo zvišane telesne temperature, hitrega dihanja, znojenja,
Aripiprazole showed an improvement on TTS-YGTSS change from baseline to week 8 of 13.35, for the low dose group (5 mg or 10 mg) and 16.94 for the high dose group (10 mg or 20 mg) as compared with an improvement of 7.09 in the placebo group.
Po jemanju aripiprazola je bilo 8. teden vidno izboljšanje s spremembo od izhodiščne vrednosti rezultata TTS-YGTSS za 13,35 točk pri skupini z nizkim odmerkom (5 mg ali 10 mg) in za 16,94 točk pri skupini z visokim odmerkom (10 mg ali 20 mg) v primerjavi z izboljšanjem za 7,09 točk pri skupini, ki je prejemala placebo.
At steady state, dehydro-aripiprazole, the active metabolite, represents about 40 % of aripiprazole AUC in plasma.
V stanju dinamičnega ravnovesja predstavlja aktivni presnovek dehidroaripiprazol okrog 40 % AUC aripiprazola v plazmi.
In sub-group analyses the point estimate of the HR was 0.495 for subjects 13 to 14 years of age compared to 0.454 for subjects 15 to 17 years of age.
Pri analizi podskupin je bila ocenjena vrednost RO pri preskušancih, starih od 13 do 14 let, 0,495 v primerjavi s preskušanci, starimi od 15 do 17 let, pri katerih je razmerje bilo 0,454.
Irritability associated with autistic disorder: the safety and efficacy of ABILIFY in children and adolescents aged below 18 years have not yet been established.
Razdražljivost, povezana z avtistično motnjo: varnost in učinkovitost zdravila ABILIFY pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
Each carton contains 1 bottle and both a calibrated polypropylene measuring cup with a graduation interval of 2.5 mL and a calibrated polypropylene low-density polyethylene dropping pipette with a graduation interval of 0.5 mL.
Ena škatla vsebuje 1 plastenko, umerjeno odmerno čašo iz polipropilena z graduacijskim intervalom2,5 ml in umerjeno kapalko iz polipropilena in polietilena majhne gostote z graduacijskim intervalom 0,5 ml.
If you miss an injection of ABILIFY
Če ste izpustili injekcijo zdravila ABILIFY
Tablet disintegration occurs rapidly in saliva.
Tableta v slini hitro razpade.
The ABILIFY solution for injection is a clear, colourless, aqueous solution.
Raztopina za injiciranje ABILIFY je bistra, brezbarvna, vodna raztopina.
Sucrose may be harmful to the teeth.
Saharoza lahko škoduje zobem.
• combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• kombinacija zvišane telesne temperature, togosti mišic, hitrega dihanja, znojenja, zmanjšane stopnje zavesti in nenadne spremembe krvnega tlaka ter hitrosti srčnega utripa, omedlevica (nevroleptični maligni sindrom),
It is important that you carry on taking ABILIFY for as long as your doctor has told you to.
ABILIFY nadaljujete tako dolgo, kot vam je svetoval zdravnik.
ABILIFY 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).
Zdravilo ABILIFY je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I ter za preprečevanje novih maničnih epizod pri odraslih bolnikih, ki so doživljali pretežno manične epizode, ki so bile odzivne na zdravljenje z aripiprazolom (glejte poglavje 5.1).
paroxetine, venlafaxine, St. John's Wort)
paroksetin, venlafaksin, šentjanževka),
According to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers (see section 4.5).
Glede na presnovno pot aripiprazola odmerka pri kadilcih ni treba prilagajati (glejte poglavje 4.5).
ABILIFY is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Zdravilo ABILIFY je indicirano za zdravljenje shizofrenije pri odraslih in mladostnikih, starih 15 let in več.