natgillin/translations-raw huggingface dataset:
Consequently, new-born infants should be monitored carefully (see section 4.8).
Zato je treba novorojenčke pozorno spremljati (glejte poglavje 4.8).
a Data were analysed using a mixed model repeated measures (MMRM) approach.
a Podatke so analizirali s pristopom mešanega modela ponovljivih meritev (MMRM).
Date of first authorisation: 15 November 2013 Date of latest renewal: 27 August 2018
Datum prve odobritve: 15. november 2013 Datum zadnjega podaljšanja:
Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.
Obvestite svojega zdravnika, če opazite katero od navedenih vedenjskih sprememb; z vami se bo pogovoril o načinih obvladovanja ali zmanjšanja simptomov.
(including so called QT prolongation seen with ECG monitoring).
(vključno s tako imenovanim podaljšanjem intervala QT, ki ga opazimo pri spremljanju EKG),
Patients should be closely monitored throughout this period.
Bolnike je treba ves čas skrbno spremljati.
• medicines that are known to prolong QT prolongation.
• zdravila, za katera je znano, da podaljšajo interval QT.
Numbers of Subjects at Risk
Število oseb s tveganjem
- if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na aripiprazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Fall: Although the available data did not provide sufficient evidence to support a clear causal relationship between aripiprazole and this ADR, 507 cases have been identified reporting 518 events of Fall associated with Abilify.
Padci: Čeprav razpoložljivi podatki niso zagotovili zadostnih dokazov v podporo jasni vzročni povezavi med aripiprazolom in tem neželenim učinkom, je bilo ugotovljenih 507 primerov, ki so poročali o 518 dogodkih padcev, povezanih z zdravilom Abilify.
• gastroesophageal reflux disease.
• gastroezofagealna refluksna bolezen.
e) Subsequently, remove the needle from the vial.
e) Nato iglo odstranite iz viale.
You may feel a little pain during the injection.
Med injiciranjem lahko začutite rahlo bolečino.
These could be signs of a condition called “tardive dyskinesia”.
To so lahko znaki stanja, imenovanega »tardivna diskinezija«;
The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g. work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours.
PSP je validirana lestvica, ki jo izpolni zdravnik, za merjenje osebnega in socialnega funkcioniranja na štirih področjih: socialno uporabne dejavnosti (npr. delo in študij), osebni in socialni odnosi, skrb zase ter moteče in agresivno vedenje.
The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known (frequency cannot be estimated from the available data):
Po trženju peroralnega aripiprazola so poročali o naslednjih neželenih učinkih, vendar njihova pogostnost ni znana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
• unable to keep still, difficulty sitting still
• nezmožnost biti pri miru, nezmožnost sedeti pri miru,
In this context, and given the seriousness of the consequences of falls, especially in elderly, the PRAC believes that an update of the Product Information with inclusion of a warning in section 4.4 of the SmPC is recommended.
Glede na to in na resnost posledic padcev, zlasti pri starejših, odbor PRAC meni, da je priporočilo o posodobitvi Informacij o zdravilu z vključitvijo opozorila v poglavju 4.4 Povzetka glavnih značilnosti zdravila utemeljeno.
• unusual movement mainly of the face or tongue, since your doctor may want to lower your dose.
• neobičajne gibe, posebej v mišicah obraza ali jezika, saj bo morda vaš zdravnik želel zmanjšati odmerek;
There are a further 154 cumulative spontaneous reports of eye movement disorder, of which 22 were serious.
Obstaja še skupaj 154 spontanih poročil o motnjah gibanja oči, od katerih je bilo
The injections will not be given intravenously.
Injekcije se ne daje intravensko.
• high blood sugar
• visok krvni sladkor,
The recommended and starting dose is 400 mg unless your doctor decided to give you a lower starting or follow up dose (300 mg, 200 mg or 160 mg).
Priporočeni začetni odmerek je 400 mg, razen če se zdravnik odloči, da vam bo dal manjši odmerek ob začetku zdravljenja ali ob spremljevalnem obisku (300 mg, 200 mg ali 160 mg).
P-value Treatment differenceb (95 % CI)
Razlika pri zdravljenjub (95-odstotni IZ)
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo.
Step 5: Procedures after injection
Korak 5: Postopki po injiciranju
The 95 % CI (-5.26, 3.99) for the difference in the estimated proportion of patients experiencing impending relapse by end of Week 26 excluded the predefined non-inferiority margin, 11.5 %.
95 % IZ (-5,26, 3,99) za razliko v ocenjenem razmerju bolnikov, pri katerih se do konca 26. tedna pojavijo znaki bližnjega relapsa bolezni, izključuje predhodno opredeljeno mejo neinferiornosti, ki znaša 11,5 %.
• kidney stones, sugar (glucose) in urine
• ledvični kamni, sladkor (glukoza) v urinu,
The safety and efficacy of Abilify Maintena in children and adolescents aged 0-17 years have not been established.
Varnost in učinkovitost zdravila Abilify Maintena pri otrocih in mladostnikih, starih od 0 do 17 let, še nista bili dokazani.
• difficulty sleeping (insomnia)
• težave s spanjem (nespečnost),
Less than 1 % of unchanged aripiprazole was excreted in the urine and approximately 18 % was recovered unchanged in the faeces.
aripiprazola se je nespremenjenega izločilo v urinu in približno 18 % ga je bilo mogoče nespremenjenega najti v blatu.
The highest non-tumorigenic exposure in female rats was approximately 7 times the human exposure at the recommended dose.
Največja netumorogena izpostavljenost samic podgan je bila 7-krat večja od izpostavljenosti človeka pri priporočenem odmerku.
• loss of strength
• izguba moči,
Personal and social functioning were evaluated using the Personal and Social Performance (PSP) scale.
Z lestvico osebne in socialne odličnosti (PSP) so ocenili osebno in socialno funkcioniranje.
Blood pressure-lowering medicines: Abilify Maintena may increase the effect of medicines used to lower the blood pressure.
Zdravila za zniževanje visokega krvnega tlaka: zdravilo Abilify Maintena lahko poveča učinek zdravil, ki se uporabljajo za zniževanje krvnega tlaka.
• akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly)
• akatizija (neprijeten občutek notranjega nemiru in nujna potreba po nenehnem gibanju),
The table is based on adverse reactions reported during clinical trials and/or post-marketing use.
Preglednica temelji na neželenih učinkih, o katerih so poročali med kliničnimi preskušanji in/ali med uporabo v obdobju trženja.
You should be given an injection every month but not before the 26 days has passed from the last injection.
Injekcijo bi morali prejeti vsak mesec, vendar ne prej kot 26 dni po zadnjem injiciranju.
Three hypodermic safety needles
Tri hipodermične varnostne igle
It should be noted that impulse-control symptoms can be associated with the underlying disorder; however, in some cases, urges were reported to have stopped when the dose was reduced or the medicinal productation was discontinued.
Upoštevati je treba, da je lahko motnja nadzora impulzov povezana z osnovno boleznijo, vendar so v nekaterih primerih poročali, da so impulzi izzveneli po zmanjšanju odmerka ali ukinitvi zdravila.
Look for signs or symptoms of inadvertent intravenous administration.
Bodite pozorni na znake ali simptome nenamernega intravenskega vbrizganja.
• dizziness when getting up from a lying or sitting position due to a drop in blood pressure
• omotičnost pri vstajanju iz ležečega ali sedeča položaja zaradi padca krvnega tlaka,
Interaction with receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of aripiprazole.
Medsebojni vpliv z drugimi receptorji, razen dopaminskih in serotoninskih podvrst, lahko razloži nekatere druge klinične učinke aripiprazola.
At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99 % bound to serum proteins, binding primarily to albumin.
terapevtskih koncentracijah sta aripiprazol in dehidroaripiprazol več kot 99 % vezana na beljakovine v serumu, predvsem na albumin.
Your doctor will make it into a suspension that will be given as an injection.
Vaš zdravnik ju bo uporabil za pripravo suspenzije, ki bo dana z injiciranjem.
All the other formulations only state in section 4.8 that dystonia is a class effect of this medication.
Za vse druge farmacevtske oblike je v poglavju 4.8 navedeno le, da je distonija neželeni učinek te skupine zdravil.
These effects gradually resolved with discontinuation of dosing.
Ti učinki so postopoma izzveneli po prekinitvi odmerjanja.
If you notice any of these symptoms seek medical advice immediately.
Če opazite katerega od teh simptomov, takoj poiščite zdravniško pomoč;
In addition, reports of accidental overdose with aripiprazole alone (up to 195 mg) in children have been received with no fatalities.
Opisani so tudi primeri naključnega prevelikega odmerjanja aripiprazola samega (do 195 mg) pri otrocih brez smrtnih primerov.
• fits (seizures) since your doctor may want to monitor you more closely
• epileptične krče (konvulzije), saj bo zdravnik v tem primeru morda želel natančneje spremljati vaše stanje,
The final efficacy analysis included 403 randomised patients and 80 exacerbations of psychotic symptoms/impending relapse events.
Končna analiza učinkovitosti je vključevala 403 randomiziranih bolnikov, pri čemer se je pri 80 bolnikih pojavilo poslabšanje psihotičnih simptomov/znaki bližnjega relapsa.
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from aripiprazole therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z aripiprazolom, pri čemer je treba upoštevati prednosti dojenja za otroka in prednosti zdravljenja za mater.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Do izboljšanja bolnikovega kliničnega stanja med antipsihotičnim zdravljenjem lahko mine od nekaj dni do več tednov.
Days from Randomization
Število dni od randomizacije
• difficulty controlling core body temperature or overheating
• težave z uravnavanjem jedrne telesne temperature ali pregrevanjem,
Step 4: Procedures after injection
Korak 4: Postopki po injiciranju
While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic medicinal products.
Ti simptomi se sicer lahko pojavijo že pri majhnih odmerkih, njihova pogostnost in resnost pa naraščata z močjo in z uporabo večjih odmerkov antipsihotikov prve generacije.
In patients who are known to be CYP2D6 poor metabolisers, the starting and maintenance dose should be 300 mg.
Pri bolnikih, za katere je znano, da slabo presnavljajo s CYP2D6, mora biti začetni in vzdrževalni odmerek 300 mg.
The injection should be administered as soon as possible and then the monthly injection schedule should be resumed.
Injekcijo je treba dati čimprej in nadaljevati z mesečnim režimom injiciranja.
They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis)
Lahko jih povzroči nenormalna razgradnja mišic, ki lahko ogroža življenje in povzroči težave z ledvicami (stanje, imenovano rabdomioliza),
Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
Med dejavniki tveganja, ki lahko povečajo bolnikovo nagnjenost k hudim zapletom, so debelost in družinska anamneza sladkorne bolezni.
deltoid gluteal
deltoidna glutealna
• heart problems or have a history of stroke, especially if you know that you have other risks factors for stroke
• težave s srcem ali anamneza možganske kapi, zlasti če veste, da imate druge dejavnike tveganja za možgansko kap,
Chemical and physical in-use stability has been demonstrated for 4 hours at 25 °C.
Zdravilo je med uporabo kemično in fizikalno stabilno 4 ure pri temperaturi 25 °C.
Oculogyric crisis: From post-marketing sources, there were 20 reports of oculogyric crisis during the interval (11 serious) and 244 reports cumulatively (92 serious).
Okulogirna kriza: Viri v obdobju trženja so v intervalu podali 20 poročil o okulogirni krizi (11 resnih) in skupaj 244 poročil (92 resnih).
• irregular heart beat or if someone else in your family has a history of irregular heart beat
• nepravilni srčni ritem ali če ima kdo drug v vaši družini anamnezo nepravilnega srčnega ritma
• weakness, loss of strength or extreme tiredness
• šibkost, izguba moči ali huda utrujenost,
• muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine.
• mišična oslabelost, občutljivost ali bolečina in še posebej, če se pojavita sočasno, se slabo počutite, imate visoko telesno temperaturo ali imate temen urin.
For all other aripiprazole products, oculogyric crisis is not listed.
Za vsa druga zdravila z aripiprazolom okulogirna kriza ni navedena.
Nevertheless, there were differences from what has been observed with maintenance use in the treatment of schizophrenia.
Vendar so kljub temu opazili razlike glede na uporabo vzdrževalnih odmerkov pri zdravljenju shizofrenije.
Given that dystonia is a well-known side effect of this drug and the large number of reported cases it seems likely that aripiprazole can cause oculogyric crisis.
Glede na to, da je distonija dobro znan neželeni učinek tega zdravila in da obstaja veliko poročil o primerih, se zdi verjetno, da lahko aripiprazol povzroči okulogirno krizo.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to zdravilo.
For oral aripiprazole, toxicologically significant effects were observed only at doses or exposures that were sufficiently in excess of the maximum human dose or exposure, indicating that these effects were limited or of no relevance to clinical use.
Za peroralni aripiprazol so toksikološko pomembne učinke opazili samo pri odmerkih ali izpostavljenosti, ki so močno presegali največje odmerke ali izpostavljenost pri človeku; to kaže, da so ti učinki za klinično uporabo le omejenega pomena ali celo nepomembni.
From a microbiological point of view, unless the method of opening/ reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Iz mikrobiološkega vidika je treba zdravilo uporabiti takoj, razen kadar način odpiranja/rekonstitucije preprečuje tveganje onesnaženja zdravila z mikrobi.
Patients must be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with aripiprazole.
Bolnicam je treba svetovati, da morajo obvestiti svojega zdravnika, če med zdravljenjem z aripiprazolom zanosijo ali nameravajo zanositi.
Do not inject into an area with signs of inflammation, skin damage, lumps and/or bruises.
Ne injicirajte na mestu, kjer so znaki vnetja, poškodbe kože, zatrdline in/ali odrgnine.
Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Zdravniku morate takoj povedati, če ste noseči oziroma mislite, da ste zanosili, ali če nameravate zanositi.
In three placebo-controlled trials of oral aripiprazole in elderly patients with psychosis associated with Alzheimer's disease (n = 938; mean age: 82.4 years; range: 56-99 years), patients treated with aripiprazole were at an increased risk of death compared to placebo.
V treh s placebom nadzorovanih preskušanjih peroralnega aripiprazola pri starejših bolnikih s psihozo, povezano z Alzheimerjevo boleznijo (n = 938; povprečna starost: 82,4 let; razpon: 56-99 let), je bilo tveganje smrti večje pri bolnikih, ki so dobivali aripiprazol, kot pri tistih, ki so dobivali placebo.
After plunger rod is at complete stop, middle stopper will be at the indicator line.
Ko se potiskalo bata povsem zaustavi, bo sredinska zaporka pri črtni oznaki.
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.