natgillin/translations-raw huggingface dataset:
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke.
Če ste starejša oseba in imate demenco (slabšanje spomina in drugih duševnih sposobnosti), morate vi ali vaš skrbnik/sorodnik zdravniku povedati, če ste kdaj imeli možgansko kap ali "malo" kap.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Med antipsihotičnim zdravljenjem lahko do izboljšanja bolnikovega kliničnega stanja mine od nekaj dni do več tednov.
• difficulty sleeping,
• težave s spanjem
If you forget to take your Aripiprazole Mylan Pharma If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.
Če ste pozabili vzeti zdravilo Aripiprazol Mylan Pharma Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite, vendar ne vzemite dveh odmerkov v enem dnevu.
In patients with severe hepatic impairment, the data available are insufficient to establish recommendations.
Pri bolnikih s hudo okvaro jeter ni dovolj podatkov, da bi lahko oblikovali priporočila.
14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets
14 tablet 28 tablet 56 tablet 98 tablet 28 x 1 tablet
Doses higher than 10 mg/day should therefore only be used in exceptional cases and with close clinical monitoring (see sections 4.4, 4.8 and 5.1).
Odmerke, večje od 10 mg/dan je zato treba uporabiti le v izjemnih primerih in ob strogem kliničnem nadzoru (glejte poglavja 4.4, 4.8 in 5.1).
It is not known if it is safe and effective in these patients.
Varnost in učinkovitost tega zdravila pri teh bolnikih nista znani.
Interaction with receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of aripiprazole.
Interakcija z drugimi receptorji razen dopaminskih in serotoninskih podvrst lahko razloži nekatere druge klinične učinke aripiprazola.
Blood pressure-lowering medicines: Aripiprazole Mylan Pharma may increase the effect of medicines used to lower the blood pressure.
Zdravila za zniževanje krvnega tlaka: zdravilo Aripiprazol Mylan Pharma lahko okrepi učinek zdravil, ki se uporabljajo za zniževanje krvnega tlaka.
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.
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.
Toksikološko pomembne učinke so opazili samo pri odmerkih ali izpostavljenosti, ki je močno presegla največje odmerke ali izpostavljenost pri človeku; to kaže, da so ti učinki za klinično uporabo le omejenega pomena ali celo nepomembni.
Try to take Aripiprazole Mylan Pharma at the same time each day.
Prizadevajte si vzeti zdravilo Aripiprazol Mylan Pharma vsak dan ob istem času.
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, sta debelost in družinska anamneza diabetesa.
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.
Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12
Farmakoterapevtska skupina: psiholeptiki, drugi antipsihotiki, oznaka ATC: N05AX12 Mehanizem delovanja
In subgroup 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.
V analizah podskupin je bila izračunana točka razmerja tveganja (HR) 0,495 za bolnike, stare 13 do 14 let, v primerjavi z 0,454 za bolnike, stare 15 do 17 let.
The total body clearance of aripiprazole is 0.7 ml/min/kg, which is primarily hepatic.
Celotni telesni očistek aripiprazola je 0,7 ml/min/kg in je v prvi vrsti hepatičen.
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).
• low levels of white blood cells,
• nizke ravni belih krvnih celic;
NMS is a potentially fatal symptom complex associated with antipsychotics.
MNS je potencialno usoden skupek simptomov, povezan z antipsihotiki.
• involuntary, irregular muscle movements, especially in the face
• imate nehotne, neredne gibe mišic, zlasti na obrazu,
The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day.
Odmerek lahko nato postopoma povečuje do priporočenega odmerka za mladostnike, ki je 10 mg enkrat na dan.
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,
• serotoninski sindrom (reakcija, ki lahko povzroči močan občutek sreče, omotico, okorelost,
Patients must be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with aripiprazole.
Bolnicam je treba naročiti, da morajo obvestiti svojega zdravnika, če med zdravljenjem z aripiprazolom zanosijo ali nameravajo zanositi.
The table is based on adverse events reported during clinical trials and/or postmarketing use.
Preglednica temelji na neželenih učinkih, o katerih so poročali med kliničnimi preskušanji in/ali med uporabo v obdobju trženja.
In a sub-analysis of the adolescent patients between the ages of 15 to 17 years, representing 74 % of the total enrolled population, maintenance of effect was observed over the 26-week open-label extension trial.
Pri analizi podskupine mladostnikov, starih od 15 do 17 let, ki je obsegala 74 % vseh vključenih bolnikov, se je učinek ohranil ves čas 26-tedenskega odprtega podaljšanega preskušanja.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Schizophrenia in adolescents
Shizofrenija pri mladostnikih
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.
Ker imajo bolniki, ki se zdravijo z antipsihotiki pogosto pridobljene dejavnike tveganja za VTE, je potrebno pred uvedbo zdravljenja in med zdravljenjem z aripiprazolom identificirati vse možne dejavnike tveganja za VTE in ustrezno preventivno ukrepati.
Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Mylan Pharma without first consulting your doctor.
Tudi če se počutite bolje, ne spreminjajte dnevnega odmerka in ne nehajte jemati zdravila Aripiprazol Mylan Pharma, ne da bi se prej posvetovali z zdravnikom.
Neuroleptic Malignant Syndrome (NMS)
Maligni nevroleptični sindrom (MNS)
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
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, vendar pa njihova pogostnost in resnost naraščata z močjo in z uporabo večjih odmerkov antipsihotikov prve generacije.
• yellowing of the skin and white part of eyes,
• porumenelost kože in očesnih beločnic,
Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation.
Aripiprazol se izdatno presnavlja v jetrih, v prvi vrsti po treh biotransformacijskih poteh: z dehidrogenacijo, hidroksilacijo in N-dealkilacijo.
• past experience with excessive gambling
• ste kdaj imeli težave s pretiranim hazardiranjem.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
• 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 pordelost noge), ki lahko potujejo po krvnih žilah v pljuča in povzročijo bolečino v prsih in težave z dihanjem (če opazite katerega od navedenih simptomov, nemudoma poiščite zdravniško pomoč),
The European Medicines Agency has deferred the obligation to submit the results of studies with aripiprazole 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 aripiprazolom 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).
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 trženja peroralne oblike aripiprazola; pogostnost pojavljanja le-teh pa ni znana:
Dizziness and vision problems may occur during treatment with this medicine (see section 4).
Med zdravljenjem s tem zdravilom se lahko pojavijo omotica in težave z vidom (glejte poglavje 4).
Impulse control disorders may result in harm to the patient and others if not recognised.
Neprepoznane motnje nadzora impulzov lahko vodijo v škodo za bolnika ali druge osebe.
Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41 % and AUC by about 51 %, suggesting that charcoal may be effective in the treatment of overdose.
Aktivno oglje (50 g), uporabljeno eno uro po aripiprazolu, je zmanjšalo Cmax aripiprazola za približno 41 % in AUC za približno 51 %, kar kaže, da bi bilo oglje lahko učinkovito za zdravljenje prevelikega odmerjanja.
A decision must be made whether to discontinue breast-feeding 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.
• accidental inhalation of food with risk of pneumonia (lung infection),
• naključno vdihanje hrane s tveganjem za pljučnico (okužba pljuč),
• involuntary loss of urine (incontinence),
• nehoteno uhajanje urina (inkontinenca),
If aripiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used.
Če aripiprazol uporabite sočasno z zdravili, za katera je znano, da podaljšajo interval QT ali povzročajo neravnovesje elektrolitov, morate biti previdni.
Aripiprazole undergoes minimal pre-systemic metabolism.
Aripiprazol je podvržen minimalni predsistemski presnovi.
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
• določene antibiotike, ki se uporabljajo za zdravljenje tuberkoloze (rifabutin, rifampicin).
This medicinal product may be started at a low dose with the oral solution (liquid) form.
Zdravnik lahko predpiše to zdravilo v majhnem začetnem odmerku v obliki peroralne raztopine (tekočine).
If you have the impression that the effect of Aripiprazole Mylan Pharma is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila Aripiprazol Mylan Pharma premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Aripiprazole is not indicated for the treatment of patients with dementia-related psychosis.
Aripiprazol ni indiciran za zdravljenje bolnikov s psihozo, povezano z demenco.
• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
• pojav sladkorne bolezni (diabetes) ali njeno poslabšanje, ketoacidoza (ketone v krvi ali v urinu) ali koma,
The point estimate of the hazard ratio (HR) was 0.461 (95% confidence interval, 0.242-0.879) in the full population.
Izračunana točka razmerja tveganja (HR) v celotni populaciji je bila 0,461 (95 % interval zaupanja, 0,242 - 0,879).
Stabilized patients were then randomised to continue the same mood stabilizer with double-blind aripiprazole or placebo.
Stabilizirane bolnike so nato randomizirali tako, da so nadaljevali zdravljenje z istim stabilizatorjem razpoloženja in dvojno slepo uporabo aripiprazola ali placeba.
Prolactin levels were evaluated in all trials of all doses of aripiprazole (n = 28,242).
V vseh preizkušanjih z vsemi odmerki aripiprazola so ocenili ravni prolaktina (n = 28.242).
Manic episodes in Bipolar I Disorder
Manične epizode pri bipolarni motnji I
At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99 % bound to serum proteins, binding primarily to albumin.
V terapevtskih koncentracijah je več kot 99 % aripiprazola in dehidroaripiprazola vezanega na beljakovine v serumu, predvsem na albumin.
Maternal toxicity occurred at doses similar to those eliciting developmental toxicity.
Učinki, toksični za mater, so se pojavili pri odmerkih, podobnih tistim, ki so izzvali razvojne toksične učinke.
However, the maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
Največji dnevni odmerek 30 mg je treba pri bolnikih s hudo okvaro jeter uporabljati previdno (glejte poglavje 5.2).
In the same trials, 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 so poročali o cerebrovaskularnih neželenih učinkih (npr. možganski kapi, prehodnem ishemičnem napadu), vključno s smrtnimi primeri (povprečna starost bolnikov: 84 let, razpon: 78-88 let).
Potential for aripiprazole to affect other medicinal products
Možnost vpliva aripiprazola na druga zdravila
• difficulty in passing urine,
• težave pri odvajanju urina,
Each tablet of 5, 10, 15, 30 mg containing 5, 10, 15, 30 mg of aripiprazole respectively.
Ena 5, 10, 15, 30 mg tableta vsebuje 5, 10, 15, 30 mg aripiprazola.
Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
Ukrepanje v primeru prevelikega odmerjanja mora biti osredotočeno na podporno zdravljenje, vzdrževanje ustreznega stanja dihal, oksigenacijo in ventilacijo ter obvladovanje simptomov.
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 izkušenj v obdobju trženja zdravila so ugotovili naključno ali namerno preveliko odmerjanje aripiprazola samega pri odraslih bolnikih z ocenjenimi odmerki do 1.260 mg brez smrtnih primerov.
In adults it also prevents this condition from returning in patients who have responded to the treatment with Aripiprazole Mylan Pharma.
Zdravilo tudi preprečuje ponovitve bolezni pri odraslih bolnikih, ki so se odzvali na zdravljenje z zdravilom Aripiprazol Mylan Pharma.
• feeling restless and unable to keep still, difficulty sitting still,
• občutek nemira in nezmožnost sedenja ali stanja pri miru,
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.
Če se pri bolniku pojavijo znaki in simptomi MNS-a ali ima nepojasnjeno zvišanje telesne temperature brez drugih kliničnih znakov MNS-a, je treba ukiniti vse antipsihotike, vključno z aripiprazolom.
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.
Other medicines and Aripiprazole Mylan Pharma Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Druga zdravila in zdravilo Aripiprazol Mylan Pharma Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili, ki ste jih dobili brez recepta.
A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
Zaviralec izločanja želodčne kisline, antagonist H2 famotidin, zmanjša hitrost absorpcije aripiprazola, vendar ta učinek ne velja za klinično pomembnega.
• feeling tired.
• utrujenost.
The overall completion rate was significantly higher for patients on aripiprazole (43 %) than for haloperidol (30 %).
Celotni delež dokončanja je bil pri bolnikih, ki so dobivali aripiprazol, značilno večji (43 %) kot pri tistih, ki so dobivali haloperidol (30 %).
Other urges, reported, include: increased sexual urges, compulsive shopping, binge or compulsive eating, and other impulsive and compulsive behaviours.
Drugi impulzi, o katerih poročajo, so: povečan spolni nagon, kompulzivno nakupovanje, kompulzivno prenajedanje in drugo impulzivno in kompulzivno vedenje.
Thus, aripiprazole is unlikely to cause clinically important medicinal product interactions mediated by these enzymes.
Zato ni verjetno, da bi aripiprazol povzročil klinično pomembno medsebojno delovanje prek teh encimov.
Valproate and lithium
Valproat in litij
It is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterised by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Uporablja se pri odraslih in mladostnikih, starih 15 let in več, za zdravljenje bolezni s simptomi, kakršni so slišanje, videnje ali občutenje stvari, ki jih v resnici ni, sumničavost, zmotna prepričanja, nepovezano govorjenje in vedenje ter čustvena praznost.
Aripiprazole Mylan Pharma with food, drink and alcohol This medicine can be taken regardless of meals.
Zdravilo Aripiprazol Mylan Pharma skupaj s hrano, pijačo in alkoholomTo zdravilo lahko jemljete ne glede na obroke.
In these patients dosing should be managed cautiously.
Pri teh bolnikih mora biti odmerjanje previdno.
Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls.
Aripiprazol lahko povzroči somnolenco, posturalno hipotenzijo, motorično in senzorično nestabilnost, ki lahko privedejo do padcev.
In a haloperidol-controlled trial, the proportion of responder patients maintaining response to medicinal product at 52-weeks was similar in both groups (aripiprazole 77 % and haloperidol 73 %).
V preskušanju, nadzorovanem s haloperidolom, je bil delež odzivnih bolnikov, pri katerih se je odziv na zdravilo ohranil po 52 tednih, v obeh skupinah podoben (aripiprazol 77 % in haloperidol 73 %).
The safety profile included weight gain and changes in prolactin levels.
Profil varnosti je vključeval podatke o povečanju telesne mase in spremembah vrednosti prolaktina.
The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
Med možnimi medicinsko resnimi znaki in simptomi so bili somnolenca, prehodna izguba zavesti in ekstrapiramidni simptomi.
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) and not known (cannot be estimated from the available data).
Vsi neželeni učinki zdravila so našteti po organskih sistemih in pogostnosti: zelo pogosti (≥ 1/10), 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).
It does not matter whether you take it with or without food.
Ni pomembno, ali jo vzamete s hrano ali brez nje, vedno pa jo vzemite z vodo in jo pogoltnite celo.
Sudden unexplained death Torsades de pointes QT prolongation Ventricular arrhythmias Cardiac arrest Bradycardia
Srčne bolezni tahikardija nenadna nepojasnjena smrt torsades de pointes podaljšanje intervala QT ventrikularna aritmija zastoj srca bradikardija
Aripiprazole is effective in maintaining the clinical improvement during continuation therapy in adult patients who have shown an initial treatment response.
Aripiprazol učinkovito vzdržuje klinično izboljšanje med nadaljevalnim zdravljenjem pri odraslih bolnikih, ki se uvodoma odzovejo na terapijo.
Based on results of a full range of standard genotoxicity tests, aripiprazole was considered nongenotoxic.
Na podlagi celotnega spektra standardnih preskusov genotoksičnosti je bilo ocenjeno, da aripiprazol ni genotoksičen.
Although the causes of deaths were varied, most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) or infectious (e.g. pneumonia) in nature (see section 4.8).
Čeprav so se vzroki smrti razlikovali, je bila večina vzrokov kardiovaskularnih (npr. srčno popuščanje, nenadna smrt) ali infekcijskih (npr. pljučnica) (glejte poglavje 4.8).
If you take more Aripiprazole Mylan Pharma than you should If you realise you have taken more Aripiprazole Mylan Pharma than your doctor has recommended (or if someone else has taken some of your Aripiprazole Mylan Pharma), contact your doctor right away.
Če ste vzeli večji odmerek zdravila Aripiprazol Mylan Pharma, kot bi smeli Če ugotovite, da ste vzeli več zdravila Aripiprazol Mylan Pharma, kot vam je priporočil zdravnik (ali če je vaše zdravilo Aripiprazol Mylan Pharma vzel kdo drug), se takoj posvetujte s svojim zdravnikom.
In this trial, patients were assigned by investigators with either open-label lithium or valproate monotherapy to determine partial non-response.
V tem preskušanju so raziskovalci bolnike najprej razporedili na odprto zdravljenje samo z litijem ali valproatom, da bi ugotovili delni neodziv.