natgillin/translations-raw huggingface dataset:
Based on the available data, this condition should be listed in all aripiprazole containing products formulations. 
Na podlagi razpoložljivih podatkov je treba to stanje navesti pri vseh farmacevtskih oblikah zdravil, ki vsebujejo aripiprazol.
Any excess should be discarded. 
Vsak presežek vehikla morate zavreči.
If aripiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used. 
Pri sočasni uporabi aripiprazola z zdravili, za katera je znano, da podaljšajo interval QT ali povzročajo neravnovesje elektrolitov, je potrebna previdnost.
What Abilify Maintena is and what it is used for 
Kaj je zdravilo Abilify Maintena in za kaj ga uporabljamo
The second trial was a 52-week, randomised, withdrawal, double-blind, trial conducted in US adult patients with a current diagnosis of schizophrenia. 
Drugo preskušanje je bilo 52-tedensko randomizirano odtegnitveno dvojno slepo preskušanje, izvedeno pri odraslih bolnikih v ZDA s trenutno diagnozo shizofrenije.
> 5 weeks 
> 5 tednov
• abnormal hair loss 
• nenormalna izguba las,
It is likely that healthcare professionals would be able to diagnose oculogyric crisis as dystonia and therefore attribute this symptom to aripiprazole, however it is unlikely that patients would be able to link the eye movements to any of the side effects listed in the PIL. 
Verjetno je, da zdravstveni delavci diagnosticirajo okulogirno krizo kot distonijo in ta simptom zato pripišejo aripiprazolu, vendar je malo verjetno, da bi bolniki sami lahko povezali gibanje oči s katerim od neželenih učinkov, navedenih v Navodilu za uporabo.
The side effects listed below may also occur after receiving Abilify Maintena. 
Spodaj navedeni neželeni učinki se tudi lahko pojavijo po dajanju zdravila Abilify Maintena.
Step 4: Injection procedure a) Detach the luer lock syringe containing the recommended volume of reconstituted Abilify Maintena suspension from the vial. 
Korak 4: Postopek injiciranja a) Z viale snemite injekcijsko brizgo z nastavkom Luer Lock, ki vsebuje priporočeno količino rekonstituirane suspenzije zdravila Abilify Maintena.
If not used immediately, in-use storage times and conditions are the responsibility of user. 
Če se zdravilo ne uporabi takoj, je za čas uporabe raztopine in pogoje shranjevanja pred uporabo odgovoren uporabnik.
Abilify Maintena also showed statistically significant improvement in symptoms represented by CGIS score change from baseline to week 10. 
Zdravilo Abilify Maintena kaže statistično pomembno izboljšanje v simptomih, predstavljenih v spremembi ocene CGIS od izhodišča do 10. tedna.
On the basis of the scientific conclusions for aripiprazole the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing aripiprazole is unchanged subject to the proposed changes to the product information. 
Na podlagi znanstvenih zaključkov za zdravilo aripiprazol odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) učinkovino aripiprazol, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Additionally, from the EudraVigilance database, at least one case is retrieved with a positive rechallenge, which conveys a probable causal association of aripiprazole use with oculogyric crisis. 
Poleg tega je iz podatkovne zbirke EudraVigilance pridobljen vsaj en primer, v katerem je po ponovni uvedbi zdravila prišlo do ponovnih pojavov simptomov, kar kaže na verjetno vzročno povezavo uporabe aripiprazola z okulogirno krizo.
The safety and efficacy of Abilify Maintena in the treatment of schizophrenia in patients 65 years of age or older has not been established (see section 4.4). 
Varnost in učinkovitost zdravila Abilify Maintena za zdravljenje shizofrenije pri bolnikih, starejših od 65 let, še nista bili dokazani (glejte poglavje 4.4).
For patients who have never taken aripiprazole, tolerability with oral aripiprazole must occur prior to initiating treatment with Abilify Maintena. 
Pri bolnikih, ki še nikoli niso jemali aripiprazola je treba pred začetkom zdravljenja z zdravilom Abilify Maintena doseči toleranco na peroralni aripiprazol.
d) Withdraw air to equalise the pressure in the vial by pulling back slightly on the plunger. 
d) Za izenačitev tlaka v viali spustite zrak, tako da bat rahlo potegnete nazaj.
Akathisia was the most frequently observed EPS symptom (Abilify Maintena 11.4 % and placebo group 3.5 %). 
Akatazija je najpogosteje opažen simptom EPS (Abilify Maintena 11,4 % in placebo 3,5 %).
Based on results of a full range of standard genotoxicity tests, aripiprazole was considered nongenotoxic. 
Na podlagi rezultatov celotnega spektra standardnih preizkusov genotoksičnosti je bilo ocenjeno, da aripiprazol ni genotoksičen.
The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms. 
Med morebitnimi medicinsko resnimi znaki in simptomi so bili somnolenca, prehodna izguba zavesti in ekstrapiramidni simptomi.
> 4 weeks and < 6 weeks 
> 4 tedne in < 6 tednov
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin) 
• določene antibiotike, ki se uporabljajo za zdravljenje tuberkoloze (rifabutin, rifampicin),
Do not use this medicine after the expiry date which is stated on the carton and the vial. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali.
Other atypical antipsychotics already have a warning in EU SmPC. 
Drugi atipični antipsihotiki že imajo opozorilo v povzetku glavnih značilnosti zdravila v EU.
Component of a multipack, can't be sold separately. 
Komponenta bolnišničnega pakiranja; ločena prodaja ni dovoljena.
Steady state concentrations for the typical subject were attained by the fourth dose for both sites of administration. 
Koncentracije v stanju dinamičnega ravnovesja pri tipični osebi so bile dosežene do četrtega odmerka na obeh mestih za odmerjanje.
• muscle movements that you cannot control such as grimacing, lip-smacking and tongue movements. 
• gibi mišic, ki jih ni mogoče nadzorovati, kot so premiki obraznih mišic, zgibki ustnic in jezika.
• involuntary loss of urine (incontinence) 
• nehotno uhajanje urina (inkontinenca),
> 6 weeks 
> 6 tednov
Sodium Abilify Maintena contains less than 1 mmol of sodium (23 mg) per dose. 
Zdravilo Abilify Maintena vsebuje manj kot 1 mmol natrija (23 mg) na odmerek.
The possibility of multiple medicinal product involvement should be considered. 
Upoštevati je treba možnost, da je stanje povzročilo več zdravil.
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 intravenoznem 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 that, treatment is given with injections of Abilify Maintena unless your doctor tells you otherwise. 
Nato se zdravljenje nadaljuje z injiciranjem zdravila Abilify Maintena, razen če zdravnik določi drugače.
All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) 
pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Abilify Maintena is only intended for intramuscular use and should not be administered intravenously or subcutaneously. 
Zdravilo Abilify Maintena je namenjeno samo intramuskularni uporabi in ga ni dovoljeno dajati intravensko ali subkutano.
It should be administered once monthly as a single injection (no sooner than 26 days after the previous injection). 
Zdravilo damo enkrat na mesec v obliki enkratne injekcije (26. dan po prejšnji injekciji in nič prej).
Further, the non-inferiority of Abilify Maintena compared to oral aripiprazole 10-30 mg is supported by the results of the analysis of the Positive and Negative Syndrome Scale score (PANSS). 
Neinferiornost zdravila Abilify Maintena v primerjavi z peroralnim aripiprazolom 10-30 mg podpirajo tudi rezultati lestvice pozitivnih in negativnih simptomov (PANSS).
• jaundice (yellowing of the skin and white part of eyes) 
• zlatenica (porumenelost kože in beločnic),
In the same trials with oral aripiprazole, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78-88 years). 
V istih preskušanjih peroralnega aripiprazola so poročali o cerebrovaskularnih neželenih učinkih (npr. možganski kapi, prehodnem ishemičnem napadu), vključno s smrtnimi primeri (povprečna starost: 84 let, razpon: 78-88 let).
• state of indifference with lack of emotion, feelings of emotional and mental discomfort 
• čustvena labilnost, • stanje ravnodušnosti z motnjami čustvovanja, občutki čustvenega in duševnega nelagodja,
Maternal toxicity occurred at doses similar to those eliciting developmental toxicity. 
Učinki, toksični za mater, so se pojavili pri odmerkih, podobnih tistim, ki so povzročili razvojne toksične učinke.
The analysis included only subjects who were randomly assigned to treatment, given at least one injection, had baseline and at least one post-baseline efficacy assessment. 
Analiza je zajela samo preiskovance, ki so bili randomizirani za zdravljenje, so prejeli vsaj eno injekcijo in pri katerih je bila opravljena ocena učinkovitosti v izhodišču ter vsaj enkrat po njem.
The PIL for these products have similar warnings regarding muscle spasms, swallowing difficulty and breathing difficulty but again no mention of eye movement disorders. 
Navodilo za uporabo teh zdravil navaja podobna opozorila glede mišičnih krčev, težav pri požiranju in težav z dihanjem, motnje gibanja oči pa spet niso omenjene.
Following multiple intramuscular doses, the plasma concentrations of aripiprazole gradually rise to a maximum plasma concentration at a median tmax of 7 days for the gluteal muscle and 4 days for the deltoid muscle. 
Po večkratnem intramuskularnem odmerjanju se koncentracije aripiprazola v plazmi postopoma dvignejo in v stanju dinamičnega ravnovesja dosežejo najvišje koncentracije v plazmi pri mediani tmax 7 dni za glutealne mišice in 4 dni za deltoidne mišice.
Water c) Slowly inject the solvent into the vial containing the powder. 
Voda c) Vehikel počasi injicirajte v vialo s praškom.
• mental disorder characterized by defective or lost contact with reality 
• duševne motnje z značilno delno ali popolno izgubo stika z realnostjo,
P-values were derived from comparison for change from baseline within analysis of covariance model with treatment as term and baseline as covariate. 
Vrednosti P temeljijo na primerjavi spremembe od izhodiščne vrednosti v modelu za analizo kovariance, pri čemer je zdravljenje spremenljivka, osnovna vrednost pa kovariat.
Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with aripiprazole and preventive measures undertaken (see section 4.8). 
Ker imajo bolniki, ki se zdravijo z antipsihotiki, pogosto pridobljene dejavnike tveganja za VTE, je treba pred in med zdravljenjem z aripiprazolom identificirati vse mogoče dejavnike tveganja za VTE in ustrezno preventivno ukrepati (glejte poglavje 4.8).
• spontaneous flow of milk from the breasts (galactorrhoea) 
• spontano izločanje mleka iz prsi (galaktoreja),
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. 
Koncentracija sulfatnih konjugatov hidroksiaripiprazola v človeškem žolču v 39-tedenski študiji ob največjem priporočenem odmerku 30 mg na dan pa je znašala le 6 % koncentracije v žolču pri opicah ter je bila bistveno nižja od meje (6 %) njihove topnosti in vitro.
In this PSUR, there are 15 spontaneous reports of oculogyric crisis (8 serious) in the interval and 223 cumulatively (78 serious) for the oral formulations, comparing to 5 spontaneous reports of oculogyric crisis (3 serious) in the interval and 21 cumulatively (14 serious) for the prolonged-release suspension for injection. 
V tem poročilu PSUR je za peroralne farmacevtske oblike v intervalu omenjenih 15 spontanih poročil o okulogirni krizi (8 resnih), skupaj 223 poročil (78 resnih), v primerjavi s 5 omenjenimi spontanimi poročili o okulogirni krizi (3 resnimi) v intervalu, skupaj 21 poročil (14 resnih) za suspenzijo za injiciranje s podaljšanim sproščanjem.
The toxicological profile for aripiprazole administered to experimental animals by intramuscular injection is generally similar to that seen following oral administration at comparable plasma levels. 
Toksikološki profil aripiprazola, danega poskusnim živalim z intramuskularnim injiciranjem, je v osnovi podoben toksikološkemu profilu po peroralni administraciji pri primerljivih plazemskih koncentracijah.
strong impulse to gamble excessively despite serious personal or family consequences altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive uncontrollable excessive shopping binge eating (eating large amounts of food in a short time period) or compulsive eating 
močna želja po čezmernem hazardiranju ne glede na posledice za vas ali za družino, spremenjeno ali povečano spolno zanimanje in vedenje, ki vam ali drugim povzroča znatno zaskrbljenost, na primer povečan libido, čezmerno nakupovanje ali trošenje denarja, ki ju ne morete nadzorovati, prenajedanje (uživanje velikih količin hrane v kratkem obdobju) ali kompulzivno uživanje hrane (uživanje večjih količin hrane od normalnih in več, kot je potrebno za potešitev lakote), nagnjenost k tavanju.
87 cases had medical history of confounding risk factors such as balance disorders, loss of consciousness, syncope, somnolence, extrapyramidal disorder, femoral fracture, alcohol abuse, bundle branch block, osteoporosis, knee arthroplasty, spinal fusion surgery, road traffic accident, fall, transient ischemic attack, cerebrovascular accident, head injury and dementia with Lewy bodies and concomitant therapy with risperidone, quetiapine fumarate, clonazepam, Latuda, valium was a confounding factor in 172 cases. 
87 primerov je imelo anamnezo motečih dejavnikov tveganja, kot so motnje ravnovesja, izguba zavesti, sinkopa, somnolenca, ekstrapiramidna motnja, zlom stegnenice, zloraba alkohola, kračni blok, osteoporoza, artroplastika kolena, operacija hrbtenične fuzije, prometna nesreča, padec, prehodni ishemični napad, srčno-žilni dogodek, poškodba glave in demenca z Lewyjevimi telesci, sočasno zdravljenje z risperidonom, kvetiapin fumaratom, klonazepamom, Latudo, valiumom pa je moteče dejavnike izzvalo v
Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties of dopaminergic hypoactivity. 
Aripiprazol je deloval antagonistično v živalskih modelih dopaminergične hiperaktivnosti in agonistično v modelu dopaminergične hipoaktivnosti.
In these patients dosing should be managed cautiously. 
Pri teh bolnikih je treba zdravilo odmerjati previdno.
Two sterile syringes, one with needle for reconstitution Three hypodermic safety needles One vial adapter 
Dve sterilni injekcijski brizgi, ena z iglo za rekonstitucijo Tri hipodermične varnostne igle En nastavek viale
While overdose is less likely with parenteral than oral medicinal products, reference information for oral aripiprazole overdose is presented below. 
Čeprav je preveliko odmerjanje manj verjetno pri parenteralnem kot pri peroralnem zdravljenju, so spodaj podani referenčni podatki za preveliko odmerjanje peroralnega aripiprazola.
• shaking or trembling 
• tresenje ali trepetanje,
What Abilify Maintena is and what it is used for What you need to know before you are given Abilify Maintena How Abilify Maintena is given 
Kaj je zdravilo Abilify Maintena in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Abilify Maintena Kako dobite zdravilo Abilify Maintena
Abilify Maintena comes as a powder which your doctor or nurse will make into a suspension. 
Zdravilo Abilify Maintena je na voljo kot prašek, ki ga zdravnik ali medicinska sestra pripravi v suspenzijo.
During the double-blind, controlled phases of the two long-term trials, injection site reactions were observed; those seen were generally mild to moderate in severity, and resolved over time. 
Med dvojno slepima nadzorovanima fazama dveh dolgotrajnih preskušanj so opazili reakcije na mestu injiciranja, ki so bile navadno blage do zmerne in so sčasoma izzvenele.
• triptans (such as sumatriptan and zolmitripitan) used for treating migraine. 
• triptane (kot sta sumatriptan in zolmitriptan) uporabljamo za zdravljenje migrene.
It is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. 
Uporabljamo ga za zdravljenje shizofrenije, t. j. bolezni s simptomi, kot so prisluhi, prividi ali občutenje stvari, ki jih v resnici ni, sumničavost, zmotna prepričanja, nepovezano govorjenje in vedenje ter čustvena praznost.
If you notice you are gaining weight, develop unusual movements, experience sleepiness that interferes with normal daily activities, any difficulty in swallowing or have allergic symptoms, please talk to your doctor immediately. 
Če opazite povečevanje telesne mase, pojav neobičajnih gibov, pretirano zaspanost, ki vpliva na običajne dnevne dejavnosti, težave s požiranjem ali znake alergije, o tem nemudoma obvestite zdravnika.
Patients fulfilling the oral stabilisation requirement in the Oral Stabilisation Phase were assigned to receive, in a single-blind fashion, Abilify Maintena and began an Abilify Maintena Stabilisation Phase for a minimum of 12 weeks and a maximum of 36 weeks. 
Bolnikom, ki so izpolnjevali zahteve za peroralno stabilizacijo v fazi peroralne stabilizacije, je bilo na enojno slepi način predpisano zdravilo Abilify Maintena, nato so začeli s fazo stabilizacije z zdravilom Abilify Maintena za obdobje najmanj 12 in največ 36 tednov.
Following any confirmed or suspected overdose with aripiprazole, close medical supervision and monitoring should continue until the patient recovers. 
Po vsakem potrjenem prevelikem odmerjanju ali sumu prevelikega odmerjanja aripiprazola je potreben natančen medicinski nadzor in spremljanje, dokler si bolnik ne opomore.
After the first injection, treatment with 10 mg to 20 mg oral aripiprazole per day should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy. 
Po prvem injiciranju je treba zdravljenje štirinajst zaporednih dni nadaljevati s peroralnim aripiprazolom 10 mg do 20 mg na dan, da bi vzdrževali terapevtske koncentracije aripiprazola na začetku zdravljenja.
Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for cholinergic muscarinic receptors. 
Aripiprazol je imel tudi zmerno vezavno afiniteto za mesta ponovnega prevzema serotonina in nobene opazne afinitete za holinergične muskarinske receptorje.
If 2nd or 3rd dose is missed and time since last injection is: 
Izpuščeni odmerki Če ste izpustili 2. ali 3. odmerek in je od zadnjega injiciranja preteklo:
The primary endpoint (change in PANSS total score from baseline to week 10) showed superiority of Abilify Maintena (n = 167) over placebo (n = 172). 
Primarna končna točka (sprememba v skupni oceni PANSS od izhodišča do 10. tedna) kaže, da je zdravilo Abilify Maintena (n = 167) superiorno placebu (n = 172).
• loss of appetite (anorexia), difficulty in swallowing 
• izguba apetita (anoreksija), težave pri požiranju,
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotics, including aripiprazole, must be discontinued (see section 4.8). 
Če se pri bolniku pojavijo znaki in simptomi MNS ali ima nepojasnjeno zvišano telesno temperaturo brez drugih kliničnih znakov MNS, je treba ukiniti vse antipsihotike, tudi zdravilo aripiprazol (glejte poglavje 4.8).
- The other ingredients are 
- Druge sestavine zdravila so:
• difficulty in passing urine 
• težave pri odvajanju urina,
• low levels of white blood cells 
• nizka raven belih krvničk,
The rate of death in oral aripiprazole-treated patients was 3.5 % compared to 1.7 % in placebo. 
Delež smrti je bil v skupini s peroralnim aripiprazolom 3,5 % v primerjavi z 1,7 % pri placebu.
Akathisia was the most frequently observed symptom (8.2 %) and typically started around day 10 after first injection, and lasted a median of 56 days. 
Najpogostejši simptom je bila akatizija (8,2 %), ki se je običajno začela približno 10. dan po prvem injiciranju in trajala povprečno 56 dni.
Neutropenia has been reported in the clinical program with Abilify Maintena and typically started around day 16 after first injection, and lasted a median of 18 days. 
Levkopenija V kliničnem programu z zdravilom Abilify Maintena so poročali o pojavu nevtropenije, ki se je običajno pojavila okoli 16. dne po prvem injiciranju in trajala povprečno 18 dni.
> 4 weeks and < 5 weeks 
> 4 tedne in < 5 tednov
Aripiprazole is not indicated for the treatment of patients with dementia-related psychosis. 
Aripiprazol ni indiciran za zdravljenje psihoze, povezane z demenco.
After multiple dose administration of Abilify Maintena, dehydro-aripiprazole, the active metabolite, represents about 29.1-32.5 % of aripiprazole AUC in plasma. 
Po večkratnem odmerjanju zdravila Abilify Maintena aktivni presnovek dehidroaripiprazol v stanju dinamičnega ravnovesja predstavlja približno 29,1-32,5 % AUC aripiprazola v plazmi.
In trials in stable patients with schizophrenia, Abilify Maintena was associated with a higher frequency of EPS symptoms (18.4 %) than oral aripiprazole treatment (11.7 %). 
V preskušanjih stabilnih bolnikov s shizofrenijo je bilo zdravilo Abilify Maintena povezano z večjo pogostnostjo ekstrapiramidnih simptomov (EPS) (18,4 %) kot pri zdravljenju s peroralnim aripiprazolom (11,7 %).
In case of dose dumping, aripiprazole concentrations are predicted to descend rapidly to the upper limit of the therapeutic window after approximately 3 days. 
V primeru sprostitve celotnega odmerka naenkrat naj bi koncentracije aripiprazola predvidoma po treh dneh hitro upadle na zgornjo mejo terapevtskega okna.
If 4th or subsequent doses are missed (i.e., after attainment of steady state) and time since last injection is: 
Če ste izpustili 4. odmerek ali katerega od nadaljnjih odmerkov (npr. po dosegu dinamičnega ravnovesja) in je od zadnjega injiciranja preteklo:
Less often substances such as propranolol and benzodiazepines (clonazepam and diazepam) were administered to control akathisia. 
Za nadzorovanje akatizije so bile manj pogosto dane snovi, kot sta propranolol in benzodiazepini (klonazepam in diazepam).
0.8 ml e) Wipe the top of the vial of the reconstituted suspension with a sterile alcohol swab. 
0,8 ml e) Vrhnji del viale z rekonstituirano suspenzijo obrišemo s sterilno alkoholno blazinico.
• past experience with excessive gambling 
• če ste kdaj imeli težave s pretiranim hazardiranjem,
Aripiprazole Long-Acting Injectable 50 mg/25 mg (n = 131) 
Dolgodelujoči parantertalni aripiprazol 50 mg/25 mg (n = 131)