natgillin/translations-raw huggingface dataset:
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)
When considering concomitant administration of ketoconazole or other potent CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient.
Pri odločanju o sočasni uporabi ketokonazola ali drugih močnih zaviralcev CYP3A4 z aripiprazolom morajo morebitne koristi odtehtati morebitna tveganja za bolnika.
What you need to know before you are given Abilify Maintena Do not use Abilify Maintena:
Kaj morate vedeti, preden boste doblili zdravilo Abilify Maintena Ne uporabljajte zdravila Abilify Maintena:
MM/YYYY
MM/LLL
Oral aripiprazole 10-30 mg/day (n = 266)
Peroralni aripiprazol 10-30 mg/dan (n = 266)
In the placebo group 39.6 % of the patients had progressed to impending relapse, whilst in the Abilify Maintena group impending relapse occurred in 10 % of the patients; thus patients in the placebo group had a 5.03-fold greater risk of experiencing impending relapse.
Iz skupine s placebom je 39,6 % bolnikov napredovalo v skupino z znaki bližnjega relapsa, medtem ko so se v skupini z zdravilom Abilify Maintena znaki bližnjega relapsa pojavili pri 10 % bolnikov, zato je pri bolnikih iz skupine s placebom obstajalo 5,03-krat večje tveganje za znake bližnjega relapsa.
When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary adenoma.
Če se pojavi, se ponavadi pojavi pri bolnikih s pomembnimi dejavniki tveganja, npr. anamnezo sladkorne bolezni, motnjami ščitnice ali adenomom hipofize.
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, zaspanost, sinkopa, zamegljen vid in diplopija (glejte poglavje 4.8).
Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69 % and 71 % lower, respectively, than those following treatment with oral aripiprazole alone.
Podobno je bila po sočasni uporabi karbamazepina geometrična sredina Cmax dehidroaripiprazola za 69 % nižja, njegov AUC pa za 71 % nižji kot po zdravljenju s samo peroralnim aripiprazolom.
• severe liver problems.
• hude težave z jetri.
b: Only patients having both baseline and at least one post baseline were included.
b: vključeni so bili samo bolniki, za katere je bila znana izhodiščna vrednost in vsaj ena nadaljnja vrednost.
A simulation of dose dumping showed that the predicted median aripiprazole concentration reaches a peak of 4,500 ng/ml or approximately 9 times the upper therapeutic range.
Simulacija sprostitve celotnega odmerka hkrati je pokazala, da predvidena mediana koncentracije aripiprazola doseže najvišjo vrednost 4.500 ng/ml ali približno 9-kratno zgornjo mejo terapevtskega območja.
The reconstituted product suspension should appear to be a uniform, homogeneous suspension that is opaque and milky-white in colour.
Rekonstituirano zdravilo mora biti na videz homogena, neprosojna in mlečno bela suspenzija.
New-born infants exposed to antipsychotics (including aripiprazole) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Pri novorojenčkih, ki so bili v tretjem trimesečju nosečnosti izpostavljeni antipsihotikom (vključno z aripiprazolom), obstaja tveganje za pojav neželenih učinkov, vključno z ekstrapiramidnimi in/ali odtegnitvenimi simptomi, ki se lahko razlikujejo glede na jakost in čas trajanja po porodu.
Needle cap d) Then pull needle-cap straight up.
Pokrovček igle d) Nato pokrovček igle povlecite naravnost navzgor.
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).
zato je treba razmisliti o nižjem začetnem odmerku (npr. pri starejših ali oslabljenih bolnikih; glejte poglavje 4.2).
- higher amounts of gamma-glutamyl transferase
- zvišane količine gama-glutamil-transferaze,
Solvent for Abilify Maintena Water for injections
Vehikel za zdravilo Abilify Maintena voda za injekcije
It has been proposed that aripiprazole's efficacy in schizophrenia is mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism at serotonin 5-HT2A receptors.
Učinkovitost aripiprazola pri shizofreniji je domnevno posledica kombinacije delnega agonizma na dopaminskih receptorjih D2 in serotoninskih receptorjih 5-HT1A ter antagonizma na serotoninskih receptorjih 5-HT2A.
g) Slowly withdraw the recommended volume from the vial into the luer lock syringe to allow for injection.
g) Priporočeno količino izvlecite iz viale v injekcijsko brizgo z nastavkom Luer Lock, da omogočite injiciranje.
Twist + Pull Off
Obrnite + snemite
Figure 1 Kaplan-Meier Product Limit Plot for Time to Exacerbation of Psychotic Symptoms/Impending Relapse
Slika 1 Analiza funkcije preživetja Kaplan-Meier za čas do poslabšanja psihotičnih simptomov/pojava znakov bližnjega relapsa
Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately.
Vialo, nastavek, injekcijsko brizgo, igle, neporabljeno suspenzijo ali vodo za injiciranje ustrezno zavrzite.
Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including accelerated or malignant.
Aripiprazol je treba previdno uporabljati pri bolnikih z znano srčnožilno boleznijo (anamnezo srčnega infarkta ali ishemično boleznijo srca, srčnim popuščanjem ali prevodnimi motnjami), cerebrovaskularno boleznijo ali stanji, ki povzročajo nagnjenost k hipotenziji (dehidracija, hipovolemija, zdravljenje z antihipertenzivi) ali hipertenziji, vključno s pospešeno in maligno hipertenzijo.
• pain at the injection site, hardening of the skin at the injection site
• bolečina na mestu injiciranja, otrdelost kože na mestu injiciranja,
Multipack Bundle pack of 3 single packs.
Skupno pakiranje 3 posameznih pakiranj.
f) Place and hold the vial of the reconstituted suspension on a hard surface.
f) Vialo z rekonstituirano suspenzijo položimo in pridržimo ob trdi površini.
Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Pri bolnikih, ki jemljejo aripiprazol, so poročali o primerih serotoninskega sindroma, morebitni znaki in simptomi tega stanja pa se lahko pojavijo zlasti ob sočasnem jemanju z drugimi serotonergičnimi zdravili, kot so selektivni zaviralci prevzema serotonina (SSRI) selektivni zaviralci prevzema noradrenalina (SNRI), ali drugimi zdravili, ki dokazano zvišujejo koncentracijo aripiprazola (glejte poglavje 4.8).