natgillin/translations-raw huggingface dataset:
NeoSpect is a kit for preparing a radiolabelled medicine.
Zdravilo NeoSpect je komplet za pripravo radioaktivno označenega zdravila.
The outcome of the NeoSpect scan was compared to the actual diagnosis, based on the histology of the
Rezultate slikanja z uporabo zdravila NeoSpect so primerjali z dejansko diagnozo na podlagi histološke preiskave vozliča (pri kateri se tkivo operativno odstranjenega vozliča analizira pod mikroskopom).
The patients underwent a chest X-ray or a CT scan as well as a SPECT scan using radiolabelled NeoSpect.
Pri bolnikih so izvedli rentgensko slikanje prsnega koša ali računalniško
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2015
Datum prve odobritve: 16 november 2015
Try to take Aripiprazole Accord at the same time each day.
Prizadevajte si vzeti zdravilo Aripiprazol Accord vsak dan ob istem času.
Consequently, the frequency of these adverse events is qualified as “not known”
Zato je pogostnost teh neželenih učinkov opredeljena kot »neznana«.
This should be considered in cases where full alertness is required, e.g. when driving a car or handling machines.
To je treba upoštevati, ko je potrebna popolna zbranost, npr. pri vožnji avtomobila ali upravljanju strojev.
Even if you feel better, do not alter or discontinue the daily dose of this medicine without first consulting your doctor.
Tudi če se počutite bolje, ne spreminjajte dnevnega odmerka in ne nehajte jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom.
• binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
- 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),
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Blood pressure-lowering medicines: Aripiprazole Accord may increase the effect of medicines used to lower the blood pressure.
Zdravila za zniževanje krvnega tlaka: zdravilo Aripiprazol Accord lahko okrepi učinek zdravil, ki se uporabljajo za zniževanje krvnega tlaka.
In adults it also prevents this condition from returning in patients who have responded to the treatment with this medicine.
Zdravilo tudi preprečuje ponovitve bolezni pri odraslih bolnikih, ki so se odzvali na zdravljenje s tem zdravilom.
• rapid heartbeat, agitation/aggressiveness, problems with speech.
• hitro bitje srca, vznemirjenost/agresivnost, težave pri govoru;
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 Accord Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite, vendar ne vzemite dveh odmerkov na en dan.
• altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
- spremenjeno ali povečano spolno zanimanje in vedenje, ki vam ali drugim povzroča znatno zaskrbljenost, na primer povečan libido,
Based on results of a full range of standard genotoxicity tests, aripiprazole was considered non genotoxic.
Na podlagi celotnega spektra standardnih preskusov genotoksičnosti je bilo ocenjeno, da aripiprazol ni genotoksičen.
Prolactin levels were evaluated in all trials of all doses of aripiprazole (n = 28,242).
V vseh preizkušanjih so ocenili raven vseh odmerkov prolaktina (n = 28.242).
It is important that you carry on taking Aripiprazole Accord for as long as your doctor has told you to.
Pomembno je, da zdravljenje z zdravilom Aripiprazol Accord nadaljujete tako dolgo, kot vam je svetoval zdravnik.
The point estimate of the hazard ratio (HR) was 0.461 (95% confidence interval, 0.242-0.879) in the full population.
Ocenjena vrednost razmerja ogroženosti (RO) je bila 0,461 (95-% interval zaupanja, 0,242-0,879) pri celotni poulaciji.
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 zdravilom Aripiprazol Accord 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).
However, the estimation of the HR for the younger (13-14 years) group was not precise, reflecting the smaller number of subjects in that group (aripiprazole, n = 29; placebo, n = 12), and the confidence interval for this estimation (ranging from 0.151 to 1.628) did not allow conclusions to be drawn on the presence of a treatment effect.
Vendar pa ocena razmerja ogroženosti pri skupini mlajših mladostnikov (13-14 let) ni bila točna zaradi manjšega števila preskušancev v tej skupini (aripiprazol, n = 29; placebo, n = 12), interval zaupanja za to oceno (ki je od 0,151 do 1,628) pa ne omogoča zaključkov o prisotnosti učinka zdravljenja.
Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
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 Accord 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.
Aripiprazole Accord contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
Zdravilo Aripiprazol Accord vsebuje zdravilno učinkovino aripiprazol in spada v skupino zdravil, imenovanih antipsihotiki.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek tega zdravila premočan ali prešibak, se posvetujte z zdravnikom ali s farmacevtom.
Taking ARIPIPRAZOLE ACCORD with some medicines may mean the doctor will need to change your dose of ARIPIPRAZOLE ACCORD or the other medicines.
Če jemljete zdravilo Aripiprazol Accord z nekaterimi drugimi zdravili, bo morda zdravnik moral spremeniti vaš odmerek zdravila Aripiprazol Accord ali drugih zdravil.
Wessling Hungary, Anonymus u. 6., Budapest, 1045, Hungary
Wessling Hungary, Anonymus u. 6., Budapest, 1045, Madžarska
What Aripiprazole Accord is and what it is used for
Kaj je zdravilo Aripiprazol Accord in za kaj ga uporabljamo
Do not use this medicine after the expiry date which is stated on the blister or label and on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu ali nalepki in na škatli poleg oznake “EXP:” ali “Uporabno do:”.
Therefore, Aripiprazole Accord is not recommended for use in patients below 13 years of age (see sections 4.8 and 5.1).
Uporabe zdravila Aripiprazol Accord se zato pri bolnikih, mlajših od 13 let, ne priporoča (glejte poglavji 4.8 in 5.1).
Extrapyramidal symptoms were mainly reported during the stabilisation phase in 17 % of patients, with tremor accounting for 6.5 %.
O ekstrapiramidnih simptomih so poročali predvsem med stabilizacijsko fazo, in sicer pri 17 % bolnikov, od tega je 6,5 % predstavljal tremor.
• strong impulse to gamble excessively despite serious personal or family consequences
- močna želja po čezmernem hazardiranju ne glede na posledice za vas ali za družino,
• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
• akutno zmedenost, krče (epilepsijo), komo, kombinacijo zvišane telesne temperature, hitrega dihanja, znojenja;
Increased mortality
Povečanje telesne mase
Patients treated with any antipsychotics, including aripiprazole, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control (see section 4.8).
Bolnike, ki dobivajo kateri koli antipsihotik, vključno z aripiprazolom, je treba opazovati glede znakov in simptomov hiperglikemije (npr. polidipsije, poliurije, polifagije in šibkosti); bolnike z diabetesom mellitusom ali dejavniki tveganja zanj pa je treba redno nadzirati, da bi odkrili poslabšanje urejenosti glukoze (glejte poglavje 4.8) .
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 upravljanja s stroji zaradi morebitnega vpliva na živčni sistem in vid, kot je sedacija, somnolenca, sinkopa, zamegljen vid in diplopija (glejte poglavje 4.8).
CARTON FOR BOTTLE AND BOTTLE LABEL
ŠKATLA ZA VSEBNIK IN NALEPKA
Developmentaltoxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were observed in rats at doses resulting in subtherapeutic exposures (based on AUC) and in rabbits at doses resulting in exposures 3 and 11 times the mean steady-state AUC at the maximum recommended clinical dose.
Razvojne toksične učinke, vključno z od odmerka odvisno zapoznelo fetalno osifikacijo in možnimi teratogenimi učinki, so pri podganah opažali v odmerkih, ki so povzročili subterapevtsko izpostavljenost (na podlagi AUC), in pri kuncih v odmerkih, ki so povzročili izpostavljenost 3- in 11kratne srednje AUC v stanju dinamičnega ravnovesja ob največjem priporočenem kliničnem odmerku.
Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Zdravilo Aripiprazol Accord je indicirano za zdravljenje shizofrenije pri odraslih in mladostnikih, starih 15 let in več.
Aripiprazole Accord is effective in a dose range of 10 to 30 mg/day.
Aripiprazol je učinkovit v razponu odmerkov od 10 do 30 mg/dan.
Medicines that increase the level of serotonin are typically used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine and pain:
Zdravila, ki povečajo raven serotonina, navadno uporabljamo za bolezni, ki vključujejo depresijo, generalizirano anksiozno motnjo, obsesivno-kompulzivno motnjo (OCD- obsessive compulsive disorder) in socialno fobijo, kot tudi za migrene in bolečine:
If you realise you have taken more Aripiprazole Accord than your doctor has recommended (or if someone else has taken some of your Aripiprazole Accord), contact your doctor right away.
Če ste vzeli večji odmerek zdravila Aripiprazol Accord, kot bi smeli Če ugotovite, da ste vzeli več zdravila Aripiprazol Accord, kot vam je priporočil zdravnik (ali če je vaše zdravilo Aripiprazol Accord vzel kdo drug), se takoj posvetujte s svojim zdravnikom.
Irritability associated with autistic disorder: the safety and efficacy of Aripiprazole Accord in children and adolescents aged below 18 years have not yet been established.
Razdražljivost, povezana z avtistično motnjo: varnost in učinkovitost zdravila Aripiprazol Accord pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of Aripiprazole Accord in the treatment of schizophrenia or manic episodes inBipolar I Disorder in patients aged 65 years and older has not been established.
Varnost in učinkovitost zdravila Aripiprazol Accord nista ugotovljeni pri zdravljenju shizofrenije ali maničnih epizod bipolarne motnje I pri bolnikih, starih 65 let in starejših.
Concomitant administration of aripiprazole and other stronginducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects and similar dose increases should therefore be applied.
Pri sočasni uporabi aripiprazola in drugih induktorjev CYP3A4 (npr. rifampicin, rifabutin, fenitoin, fenobarbital, primidon, efavirenz, nevirapin in šentjanževka) je mogoče pričakovati, da imajo podobne učinke, zato je treba odmerjanje podobno zvečati.
It has been proposed that aripiprazole's efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
Učinkovitost aripiprazola pri shizofreniji in bipolarni motnji I je domnevno posledica kombinacije delnega agonizma na dopaminskih receptorjih D2 in serotoninskih receptorjih 5-HT1a ter antagonizma na serotoninskih receptorjih 5-HT2a.
What Aripiprazole Accord is and what it is used for What you need to know before you take Aripiprazole Accord How to take Aripiprazole Accord Possible side effects 5 How to store Aripiprazole Accord Contents of the pack and other information
Kaj je zdravilo Aripiprazol Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Aripiprazol Accord Kako jemati zdravilo Aripiprazol Accord Možni neželeni učinki
Potential for aripiprazole to affect other medicinal products In clinical studies, 10-30 mg/day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan).
V kliničnih študijah odmerki od 10 do 30 mg aripiprazola na dan niso pomembno vplivali na presnovo substratov CYP2D6 (razmerje dekstrometorfan/3-metoksimorfinan), CYP2C9 (varfarin), CYP2C19 (omeprazol) ali CYP3A4 (dekstrometorfan).
The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:
O naslednjih neželenih učinkih so poročali v obdobju od prihoda zdravila aripiprazol v obliki peroralne raztopine na trg; pogostnost pojavljanja le-teh pa ni znana:
• The other ingredients are lactose monohydrate, cellulose microcrystalline,maize starch, hydroxypropylcellulose , magnesium stearate, and indigo carmine aluminium lake (E132) (for 5 mg) or iron oxide red (E172) (for 10 mg and 30 mg) or iron oxide yellow (E172) (for 15 mg).
• Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, hidroksipropilceluloza, magnezijev stearat, in indigotin (E 132) (za 5 mg), rdeč železov oksid (E 172) (za 10 mg and 30 mg), rumen železov oksid (E 172) (za 15 mg).
LIST OF EXCIPIENTS Contains lactose monohydrate.
SEZNAM POMOŽNIH SNOVI Vsebuje laktoza monohidrat.
This medicine is used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
To zdravilo uporabljamo za zdravljenje odraslih in mladostnikov, starih 13 let in več, ki imajo težave s simptomi, kot so evforično razpoloženje, pretirana energija, zmanjšana potreba po spanju, hitro govorjenje s prehitevajočimi mislimi in občasno huda razdražljivost.
A, aripiprazole should be used with caution in patients with a family history of QT prolongation (see section 4.8).
Aripiprazol je treba uporabljati previdno pri bolnikih z družinsko anamnezo podaljšanja intervala QT (glejte poglavje 4.8).
Tics associated with Tourette's disorder: the safety and efficacy of Aripiprazole Accord in children and adolescents 6 to 18 years of age have not yet been established.
Trzaji, povezani s Tourettovim sindromom: varnost in učinkovitost zdravila Aripiprazol Accord pri otrocih in mladostnikih, starih od 6 do 18 let, še ni bila dokazana.
In a 60- to 89-week, randomised, double-blind, placebo-controlled trial in adolescent subjects (n = 146; ages 13-17 years) with schizophrenia, there was a statistically significant difference in the rate of relapse of psychotic symptoms between the aripiprazole (19.39%) and placebo (37.50%) groups.
V 60- do 89-tedenskem, randomiziranem, dvojnoslepem, s placebom kontroliranem preskušanju pri mladostnikih s shizofrenijo (n = 146; v starosti od 13 do 17 let) je bilo opaziti statistično značilno razliko v stopnji ponovitve psihotičnih simptomov med skupinama bolnikov, zdravljenih z aripiprazolom (19,39 %) in s placebom (37,50 %).
(for 100's count) Do not throw away any medicines via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
• uncontrollable excessive shopping
- čezmerno nakupovanje, ki ga ne morete nadzorovati,
The safety profile of a long-term, double-blind placebo controlled trial was also similar except for the following reactions that were reported more frequently than paediatric patients taking placebo: weight decreased, blood insulin increased, arrhythmia, and leukopenia were reported commonly (≥ 1/100, <
Profil varnosti v dolgotrajnem dvojnoslepem, s placebom nadzorovanem kliničnem preskušanju je bil prav tako podoben, razen pri naslednjih reakcijah, o katerih so poročali pogosteje pri pediatričnih bolnikih, ki so jemali placebo: pogosto so navajali zmanjšanje telesne mase, zvišano vrednost inzulina v krvi, aritmijo in levkopenijo (≥ 1/100, < 1/10).
If you are taking ARIPIPRAZOLE ACCORD, your doctor will discuss with you whether you should breast-feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding.
Če prejemate zdravilo Aripiprazol Accord, vam bo zdravnik pomagal pri odločitvi glede dojenja z upoštevanjem prednosti dojenja za otroka in prednosti zdravljenja za vas.
• in blood tests: fluctuating blood sugar, increased glycosylated haemoglobin.
• krvne preiskave: nihanje ravni sladkorja v krvi, zvišana raven glikoziliranega hemoglobina,
Aripiprazole Accord 5/10/15 mg tablets are available in HDPE bottle with PPCRC closure containing 30 or 100 tablets.
Aripiprazol Accord 5/10/15 mg tablete so na voljo v HDPE vsebniku z zapiranjem PPCRC v pakiranju po 30 ali 100 tablet.
Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).
Zdravilo Aripiprazol Accord je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I ter za preprečevanje novih maničnih epizod pri odraslih bolnikih, ki so doživljali pretežno manične epizode, ki so bile odzivne na zdravljenje z aripiprazolom (glejte poglavje 5.1).
It is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole.
Pomembno je, da zdravniki, ki zdravilo predpišejo, bolnike ali njihove skrbnike posebej vprašajo, ali se je pri njih med zdravljenjem z apriprazolom pojavila ali povečala želja po hazardiranju, spolni nagon, kompulzivno nakupovanje, kompulzivno prenajedanje ali drugi impulzi.
Aripiprazole showed an improvement on TTS-YGTSS change from baseline to week 8 of 13.35,for the low dose group (5 mg or 10 mg) and 16.94 for the high dose group (10 mg or 20 mg) as compared with an improvement of 7.09 in the placebo group.
Po jemanju aripiprazola je bilo 8. teden vidno izboljšanje s spremembo od izhodiščne vrednosti rezultata TTS-YGTSS za 13,35 točk pri skupini z nizkim odmerkom (5 ali 10 mg) in za 16,94 točk pri skupini z visokim odmerkom (10 ali 20 mg) v primerjavi z izboljšanjem za 7,09 točk pri skupini, ki je prejemala placebo.
For patients receiving aripiprazole, the median time to onset was 30 days and median duration was 194 days.
Mediana časa do pojava je bila za bolnike, ki so prejemali aripiprazol, 30 tednov, mediana trajanja pa 194 dni.
- 30 day (for HDPE 30's count) - 100 day (for HDPE 100's count)
Rok uporabnosti po prvem odpiranju; - 30 dni (za HDPE vsebnike s 30 tabletami) - 100 dni (za HDPE vsebnike s 100 tabletami)
Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
Učinek zdravil iz te skupine (“Class effect”) - V prvih nekaj dneh zdravljenja se lahko pri dovzetnih posameznikih pojavijo simptomi distonije, podaljšane nenormalne kontrakcije mišičnih skupin.
Pathological gambling and other impulse control disorders Pathological gambling, hypersexuality, compulsive shopping and binge or compulsive eating can occur in patients treated with aripiprazole (see section 4.4).
Patološko hazardiranje in druge motnje nadzora impulzov Pri bolnikih, ki se zdravijo z apriprazolom, se lahko pojavijo patološko hazardiraje, povečan spolni nagon, kompulzivno nakupovanje in kompulzivno prenajedanje (glejte poglavje 4.4).
• Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.
Z vami se bo pogovoril o načinih obvladovanja ali zmanjšanja simptomov.
Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
The following symptoms may occur in newborn babies, of mothers that have used this medicine in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti uporabljale to zdravilo, se lahko pojavijo naslednji simptomi: tresenje, okornost ali šibkost mišic, zaspanost, nemir, težave z dihanjem in motnje hranjenja.
Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax and AUC for aripiprazole were 68 % and 73 % lower, respectively, compared to when aripiprazole (30 mg) was administered alone.
Po sočasni uporabi karbamazepina, močnega induktorja CYP3A4, in peroralnega aripiprazola pri bolnikih s shizofrenijo shizoafektivno motnjo je bila geometrična sredina Cmax za 68 % nižja, AUC pa za 73 % nižja kot po uporabi samega aripiprazola (30 mg).
An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of hydroxy metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 to 125 mg/kg/day (1 to 3 times the mean steady-state AUC at the maximum recommended clinical dose or 16 to 81 times the maximum recommended human dose based on mg/m2).
Dodaten izsledek je bila holelitiaza zaradi precipitacije sulfatnih konjugatov hidroksipresnovkov aripiprazola v žolču opic po ponavljajočem odmerjanju od 25 do 125 mg/kg/dan (1- do 3-kratna srednja AUC v stanju dinamičnega ravnovesja ob največjem priporočenem kliničnem odmerku ali 16- do 81-kratni največji priporočeni odmerek za človeka glede na mg/m2).