FrancophonIA/ELRC3.0 huggingface dataset:
English: Reporting suspected adverse reactions after authorisation of the medical product is important.
Slovenian: Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
English: Do not use Xeplion - if you are allergic to paliperidone or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Xeplion - če ste alergični na paliperidon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Xeplion can help alleviate the symptoms of your disease and stop your symptoms from coming back.
Slovenian: Zdravilo Xeplion pomaga lajšati simptome vaše bolezni in preprečuje, da bi se ponovno pojavili.
English: The release of the active substance starts as early as day 1 and lasts for at least 4 months.
Slovenian: Sproščanje zdravilne učinkovine se začne že 1. dan in traja vsaj 4 mesece.
English: Four metabolic pathways have been identified in vivo, none of which accounted for more than 6.5% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Slovenian: In vivo so odkrili štiri presovne poti, od katerih nobena ni predstavljala več kot 6,5% odmerka: dealkilacija, hidroksilacija, dehidrogenacija in cepitev benzizoksazola.
English: The relevance of these tumour findings in rodents in terms of human risk is unknown.
Slovenian: Pomen teh ugotovitev pri glodalcih za tveganje pri človeku ni znan.
English: For example, a person with schizophrenia may hear voices or see things that are not there (called hallucinations), believe things that are not true (called delusions), or feel unusually suspicious of others.
Slovenian: Na primer oseba s shizofrenijo sliši glasove ali vidi stvari, ki jih ni (halucinacije), verjame v stvari, ki niso resnične (blodnje) ali je nenavadno sumničava do drugih.
English: Each injection should be administered by a health care professional.
Slovenian: Vsako injiciranje mora opraviti zdravstveni delavec.
English: The following terms and frequencies are applied: 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).
Slovenian: Pri navajanju pogostnosti neželenih učinkov so uporabljeni naslednji izrazi in pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Because of the difference in median pharmacokinetic profiles between the two medicinal products, caution should be exercised when making a direct comparison of their pharmacokinetic properties.
Slovenian: Zaradi razlike v mediani farmakokinetičnih profilov med obema zdraviloma, je pri neposredni primerjavi njunih farmakokinetičnih lastnosti potrebna previdnost.
English: • inability to reach orgasm
Slovenian: • nezmožnost doseganja orgazma
English: After the injection is complete, use either thumb or finger of one hand (8a, 8b) or a flat surface (8c) to activate the needle protection system.
Slovenian: Ko je injiciranje končano, s palcem ali prstom ene roke (8a, 8b) ali plosko površino (8c) aktivirajte sistem za zaščito igle.
English: Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive by one dose level at the time of your scheduled monthly injection.
Slovenian: Glede na vaše simptome lahko zdravnik poveča ali zmanjša količino zdravila, ki jo boste prejeli ob naslednjem načrtovanem mesečnem injiciranju.
English: What you need to know before you use Xeplion
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Xeplion
English: If you have moderate or severe kidney problems this medicine should not be used.
Slovenian: Če pa imate zmerno ali hudo okvaro ledvic, tega zdravila ne smete uporabljati.
English: • decreased oxygen in parts of your body (because of decreased blood flow)
Slovenian: • zmanjšanje kisika v delih telesa (zaradi zmanjšanega pretoka krvi)
English: No in vivo data are available and the clinical relevance is unknown.
Slovenian: Podatkov in vivo ni, klinična pomembnost pa ni znana.
English: You should not use this medicine during pregnancy unless this has been discussed with your doctor.
Slovenian: Med nosečnostjo ne smete uporabljati tega zdravila, razen če ste se o tem pogovorili z zdravnikom.
English: Extrapyramidal symptoms (EPS)
Slovenian: Ekstrapiramidni simptomi (EPS)
English: Elderly patients with dementia
Slovenian: Starejši bolniki z demenco
English: The PSP is a validated clinician rated scale that measures personal and social functioning in four domains: socially useful activities (work and study), personal and social relationships, self-care and disturbing and aggressive behaviours.
Slovenian: PSP je validirana lestvica, ki jo izpolni zdravnik, meri pa osebno in socialno delovanje na štirih področjih: družbeno koristne dejavnosti (delo in študij), osebna in družbena razmerja, samooskrba ter moteče in agresivno vedenje.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xeplion in all subsets of the paediatric population in schizophrenia.
Slovenian: Evropska agencija za zdravila (EMA) je odstopila od obveznosti predložitve rezultatov študij zdravila Xeplion pri vseh podskupinah pediatrične populacije s shizofrenijo.
English: Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias.
Slovenian: Takoj je treba začeti spremljanje srca in ožilja, ki mora vključevati neprekinjeno elektrokardiografsko spremljanje zaradi morebitnih aritmij.
English: • sugar in the urine
Slovenian: • prisotnost sladkorja v urinu
English: Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents.
Slovenian: Hipotenzijo in cirkulatorni kolaps je treba zdraviti z ustreznimi ukrepi, kot so dajanje intravenskih tekočin in/ali simpatikomimetikov.
English: The results of the other studies yielded statistically significant results in favour of Xeplion, except for the 50 mg dose in one study (see table below).
Slovenian: Druge študije so pokazale statistično pomembne rezultate v korist zdravila Xeplion, razen v eni študiji pri odmerku 50 mg (glejte spodnjo preglednico).
English: For example, a person with schizophrenia may appear withdrawn and may not respond at all emotionally or may have trouble speaking in a clear and logical way.
Slovenian: Na primer oseba s shizofrenijo je otopela in se čustveno ne odziva ali ima težave pri jasnem in logičnem govorjenju.
English: Patients should be informed to seek urgent medical care in case that priapism has not been resolved within 4 hours.
Slovenian: Bolnike je treba poučiti, da poiščejo zdravniško pomoč, če priapizem ne izveni v 4 urah.
English: There were no relevant effects observed in the non-clinical studies.
Slovenian: V nekliničnih študijah niso opazili pomembnih učinkov.
English: Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Slovenian: Pri tistih, ki so jih zdravili z risperidonom, je bila smrtnost 4%, v primerjavi s 3,1% pri placebu.
English: Do not use this medicine after the expiry date which is stated on the carton.
Slovenian: Tega zdravila ne smete uporabljati po izteku roka uporabnosti, ki je naveden na škatli.
English: You should not stop using this medicine unless told to do so by your doctor as your symptoms may return.
Slovenian: Uporabe tega zdravila ne smete prekiniti, razen če vam je to naročil zdravnik, saj se lahko znova pojavijo simptomi bolezni.
English: • loss of appetite resulting in malnutrition and low body weight
Slovenian: • izguba apetita, ki vodi v nezadostno prehranjenost in majhno telesno maso
English: Use in patients who are in an acutely agitated or severely psychotic state
Slovenian: Uporaba pri bolnikih v akutno agitiranem ali zelo psihotičnem stanju
English: Negative means a lack of behaviours or feelings that are normally present.
Slovenian: Negativni odražajo pomanjkanje normalnih občutkov ali vedenj.
English: The PANSS is a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganised thoughts, uncontrolled hostility/excitement and anxiety/depression.
Slovenian: Lestvica PANSS je validiran vprašalnik z več postavkami, sestavljen iz petih dejavnikov za ocenjevanje pozitivnih simptomov, negativnih simptomov, neorganiziranih misli, nenadzorovane sovražnosti/razburjenja in tesnobe/depresije.
English: Since this medicine can lower blood pressure, care should be taken when this medicine is used with other medicines that lower blood pressure.
Slovenian: To zdravilo lahko zniža krvni tlak, zato morate biti previdni, če ga uporabljate skupaj z drugimi zdravili, ki tudi znižujejo krvni tlak.
English: • symptoms of drug withdrawal
Slovenian: • simptomi odtegnitve zdravila
English: Gradual withdrawal of stimulant treatment is recommended (see section 4.5).
Slovenian: Priporočljiva je postopna ukinitev zdravljenja s stimulansi (glejte poglavje 4.5).
English: Nervous system disorders parkinsonism c,
Slovenian: Bolezni živčevja parkinsonizem c,
English: Log-rank test, P-value<0.0001
Slovenian: test log-rank, vrednost p < 0,0001
English: When making dose adjustments, the prolonged release characteristics of Xeplion should be considered (see section 5.2), as the full effect of maintenance doses may not be evident for several months.
Slovenian: Pri prilagajanju odmerka je treba upoštevati podaljšano sproščanje zdravila Xeplion (glejte poglavje 5.2), saj se celotni učinek vzdrževalnih odmerkov lahko razvije po več mesecih.
English: The following information is intended for medical or healthcare professionals only and should be read by the medical or healthcare professional in conjunction with the full prescribing information (Summary of Product Characteristics).
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju, ki jih mora prebrati skupaj z informacijami za predpisovanje (Povzetek glavnih značilnosti zdravila).
English: Figure 1: Kaplan-Meier Plot of Time to Relapse - Interim Analysis (Intent-to-Treat Interim Analysis Set)
Slovenian: Slika 1: Kaplan-Meierjeva ocena časa do relapsa - vmesna analiza (niz vmesnih analiz pri populaciji, ki so jo nameravali zdraviti)
English: The primary efficacy endpoint was defined as a decrease in Positive and Negative Syndrome Scale (PANSS) total scores as shown in the table below.
Slovenian: Primarni končni cilj učinkovitosti je bil skupna vrednost lestvice pozitivnih in negativnih sindromov (PANSS - Positive and Negative Syndrome Scale), kot je prikazano v spodnji preglednici.
English: Functioning was evaluated using the Personal and Social Performance (PSP) scale.
Slovenian: Funkcioniranje bolnikov so ocenjevali z lestvico za oceno osebnostnega in socialnega delovanja (PSP - Personal and Social Performance).
English: This medicine is administered by your doctor or other health care professional.
Slovenian: To zdravilo vam bo injiciral zdravnik ali drug zdravstveni delavec.
English: Do not administer intravascularly or subcutaneously.
Slovenian: Ne injicirajte intravaskularno ali subkutano.
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Slovenian: Priporoča se ustrezno klinično spremljanje v skladu z veljavnimi priporočili za antipsihotike.
English: Acute treatment of schizophrenia
Slovenian: Akutno zdravljenje shizofrenije
English: No interaction study between Xeplion and lithium has been performed, however, a pharmacokinetic interaction is not likely to occur.
Slovenian: Študij medsebojnega delovanja zdravila Xeplion in litija niso izvedli, vendar ni verjetno, da bo prišlo do farmakokinetične interakcije.
English: This decrease is caused, to a substantial degree, by a 35% increase in renal clearance of paliperidone likely as a result of induction of renal P-gp by carbamazepine.
Slovenian: To zmanjšanje je, v veliki meri, povzročeno s 35% povečanjem ledvičnega očistka paliperidona, verjetno zaradi indukcije ledvičnega P-gp s karbamazepinom.
English: • white blood cell count decreased, decrease in the type of white blood cells that help to protect you against infection, decrease in platelets (blood cells that help you stop bleeding), anaemia
Slovenian: • zmanjšano število belih krvnih celic, zmanjšano število vrste belih krvnih celic, ki vas pomagajo varovati pred okužbami, zmanjšanje števila krvnih ploščic (krvne celice, ki pomagajo zaustaviti krvavitev), slabokrvnost (anemija)
English: Safety data involving concomitant use of Xeplion with other antipsychotics is limited.
Slovenian: Podatki o varnosti sočasne uporabe zdravila Xeplion in drugih antipsihotikov so omejeni.
English: This medicine may cause an electrocardiogram (ECG) abnormality demonstrating a long time for an electrical impulse to travel through a certain part of the heart (known as “QT prolongation”).
Slovenian: To zdravilo lahko povzroči nepravilnosti na elektrokardiogramu (EKG), ki se kaže kot podaljšano potovanje impulza skozi določen del srca (imenovano tudi »podaljšanje intervala QT«).
English: • yellowing of the skin and the eyes (jaundice)
Slovenian: • porumenelost kože in oči (zlatenica)
English: • breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
Slovenian: • razgradnja mišičnih vlaken in bolečine v mišicah (rabdomioliza)
English: Taking this medicine with carbamazepine (an anti-epileptic and mood stabiliser) may require a change to your dose of this medicine.
Slovenian: Sočasno jemanje tega zdravila s karbamazepinom (ki je zdravilo proti epilepsiji in stabilizator razpoloženja) bo morda treba prilagoditi odmerjanje tega zdravila.
English: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to End Point- LOCF for Studies R092670-SCH-201, R092670-PSY-3003, R092670-PSY-3004 and R092670-PSY-3007: Primary Efficacy Analysis Set Placebo
Slovenian: Skupna vrednost lestvice pozitivnih in negativnih sindromov shizofrenije (PANSS) - sprememba od izhodišča do končne točke - s prenosom zadnjega opažanja (LOCF) pri študijah R092670-SCH-201, R092670-PSY-3003, R092670-PSY-3004 in R092670-PSY-3007: niz primarnih analiz učinkovitosti Placebo
English: This list is indicative and not exhaustive.
Slovenian: Ta seznam je okviren in ne vsebuje vseh učinkovin.
English: Patients with severe neutropenia (absolute neutrophil count < 1 x 10
Slovenian: Pri bolnikih s hudo nevtropenijo (absolutno število nevtrofilcev < 1 x 10
English: In general, recommended dosing of Xeplion for elderly patients with normal renal function is the same as for younger adult patients with normal renal function.
Slovenian: Priporočeno odmerjanje zdravila Xeplion pri starejših bolnikih z normalnim delovanjem ledvic je enako kot pri mlajših odraslih bolnikih z normalnim delovanjem ledvic.
English: This medicine can reduce the effect of medicines against Parkinson's disease and restless legs syndrome (e.g., levodopa).
Slovenian: To zdravilo lahko zmanjša učinke zdravil za zdravljenje Parkinsonove bolezni in sindroma nemirnih nog (npr. levodope).
English: The pharmacological activity of the (+)- and (-)-paliperidone enantiomers are qualitatively and quantitatively similar.
Slovenian: Farmakološko delovanje (+) in (-) enantiomera paliperidona je kvalitativno in kvantitativno podobno.
English: Hypersensitivity to the active substance, to risperidone or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino, risperidon ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: For instructions for use and handling of Xeplion, see package leaflet (information intended for medical or healthcare professionals).
Slovenian: Za navodila za pripravo in ravnanje z zdravilom Xeplion glejte navodilo za uporabo (informacije za zdravstveno osebje).
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including paliperidone, should be considered.
Slovenian: Če se pojavijo znaki in simptomi tardivne diskinezije, je treba razmisliti o prekinitvi uporabe vseh antipsihotikov, vključno s paliperidonom.
English: Injury, poisoning and procedural complications fall
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih padci
English: Refer to ‘Hyperprolactinaemia' below.
Slovenian: Glejte ‘hiperprolaktinemija' spodaj.
English: There are no adequate data from the use of paliperidone during pregnancy.
Slovenian: O uporabi paliperidona med nosečnostjo ni zadostnih podatkov.
English: Following administration of paliperidone palmitate the (+) and (-) enantiomers of paliperidone interconvert, reaching an AUC (+) to (-) ratio of approximately 1.6-1.8.
Slovenian: Po injiciranju paliperidonijevega palmitata se (+) in (-) enantiomera medseboj pretvorita tako, da je razmerje AUC med (+) in (-) enantiomerom približno 1,6-1,8.
English: There is no specific antidote to paliperidone.
Slovenian: Specifičnega antidota za paliperidon ni.
English: • serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing
Slovenian: • resna alergijska reakcija z otekanjem, ki lahko zajame grlo in povzroči oteženo dihanje
English: If a patient develops signs or symptoms indicative of NMS, paliperidone should be discontinued.
Slovenian: Če se pri bolniku pojavijo znaki ali simptomi, ki kažejo na NMS, je treba paliperidon ukiniti.
English: • excessive drinking of water
Slovenian: • prekomerno pitje vode
English: Paliperidone can have minor or 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 (see section 4.8).
Slovenian: Paliperidon ima lahko blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji zaradi možnega delovanja na živčevje in vid, kot so sedacija, somnolenca, sinkopa in zamegljen vid (glejte poglavje 4.8).
English: • low blood sugar
Slovenian: • nizka koncentracija sladkorja v krvi
English: The safety and efficacy of Xeplion in children and adolescents < 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Xeplion pri otrocih, mlajših od 18 let, nista ugotovljeni.
English: Concomitant use of Xeplion with psychostimulants
Slovenian: Sočasna uporaba zdravila Xeplion in psihostimulansov
English: • trouble breathing during sleep (sleep apnoea)
Slovenian: • težko dihanje med spanjem (začasno prenehanje dihanja med spanjem)
English: Since this medicine may reduce your urge to vomit, there is a chance that it may mask the body's normal response to ingestion of toxic substances or other medical conditions.
Slovenian: To zdravilo lahko zmanjša potrebo po bruhanju, zato lahko prikrije normalen odziv telesa na zaužitje strupenih snovi ali druga zdravstvena stanja.
English: In this study, doses of Xeplion included 25, 50, 75, and 100 mg administered monthly; the 75 mg dose was allowed only in the 52-week open-label extension.
Slovenian: V tej študiji so zdravilo Xeplion dajali v odmerkih 25, 50, 75 in 100 mg enkrat na mesec; odmerek 75 mg je bil dovoljen samo v 52-tedenskem odprtem podaljšku.
English: • not moving or responding while awake (catatonia)
Slovenian: • negibnost ali neodzivnost v budnem stanju (katatonija)
English: Even though paliperidone is a strong D2-antagonist, which is believed to relieve the positive symptoms of schizophrenia, it causes less catalepsy and decreases motor functions less than traditional neuroleptics.
Slovenian: Čeprav je paliperidon močan antagonist D2 in menijo, da tako ublaži pozitivne simptome shizofrenije, v primerjavi s klasičnimi nevroleptiki povzroči manj katalepsije in manj oslabi motorično funkcijo.
English: The suspension for injection is for single use only.
Slovenian: Suspenzija za injiciranje je namenjena samo eni uporabi.
English: * For Study R092670-PSY-3007 an initiation dose of 150 mg was given to all subjects in the Xeplion treatment groups on day 1 followed by the assigned dose afterwards.
Slovenian: * V študiji R092670-PSY-3007 so uvajalni odmerek 150 mg prvi dan dali vsem preizkušancem v skupinah, ki so jih zdravili z zdravilom Xeplion, nato je sledil dodeljeni odmerek.
English: Other medicines and Xeplion Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: • low blood pressure, low blood pressure upon standing (consequently, some people taking this medicine may feel faint, dizzy, or may pass out when they stand up or sit up suddenly)
Slovenian: • nizek krvni tlak, nizek krvni tlak, ko vstanete (zato lahko nekateri ljudje, ki prejemajo to zdravilo, občutijo omedlevico, omotico ali pa se ob hitrem vstajanju ali usedanju iz ležečega položaja zgrudijo)
English: If you stop receiving your injections, you will lose the effects of the medicine.
Slovenian: Če ste prenehali uporabljati zdravilo Xeplion Če prenehate prejemati injekcije, bodo učinki zdravila izginili.
English: Xeplion is intended for intramuscular use only.
Slovenian: Zdravilo Xeplion je namenjeno samo intramuskularni uporabi.
English: In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicinal products metabolised by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5.
Slovenian: Študije in vitro na človeških jetrnih mikrosomih so pokazale, da paliperidon bistveno ne zavira presnove zdravil, ki se presnavljajo z izoencimi citokroma P450, vključno s CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4 in CYP3A5.
English: This medicine has not been studied in elderly patients with dementia.
Slovenian: Tega zdravila niso preučevali pri starejših bolnikih z demenco.
English: Paliperidone palmitate and paliperidone were not genotoxic.
Slovenian: Paliperidonijev palmitat in paliperidon nista bila genotoksična.
English: Elimination of paliperidone decreased with decreasing estimated creatinine clearance.
Slovenian: Izločanje paliperidona se je zmanjšalo skladno z oceno zmanjševanja očistka kreatinina.
English: Xeplion contains a racemic mixture of (+)- and (-)-paliperidone.
Slovenian: Zdravilo Xeplion vsebuje racemat (+) in (-) paliperidona.
English: If you cannot keep your appointment with the doctor, make sure you call him right away so another appointment can be made as soon as possible.
Slovenian: Če ne morete priti na naročeno injiciranje, takoj pokličite zdravnika, da vas čim prej naroči na drug termin.
English: Paliperidone is not bound to cholinergic receptors.
Slovenian: Paliperidon se ne veže na holinergične receptorje.
English: The most commonly reported injection site related adverse reaction was pain.
Slovenian: Najpogostejši neželeni učinek, povezan z mestom injiciranja, je bila bolečina.
English: One week following administration of a single oral dose of 1 mg immediate-release
Slovenian: En teden po uporabi enkratnega peroralnega odmerka 1 mg
English: • dangerously excessive intake of water
Slovenian: • nevarno prekomerno pitje vode
English: Very common side effects: may affect more than 1 in 10 people • difficulty falling or staying asleep.
Slovenian: Zelo pogosti: pojavijo se lahko pri vsaj 1 od 10 bolnikov • težave z uspavanjem ali vzdrževanjem spanca
English: What Xeplion is and what it is used for What you need to know before you use Xeplion How to use Xeplion
Slovenian: Kaj je zdravilo Xeplion in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Xeplion Kako uporabljati zdravilo Xeplion Možni neželeni učinki