FrancophonIA/ELRC3.0 huggingface dataset:
English: Physicians should weigh the risks versus the benefits when prescribing Xeplion to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotics.
Slovenian: Zdravnik mora pretehtati tveganja in koristi predpisovanja antipsihotikov, vključno z zdravilom Xeplion bolnikom s Parkinsonovo boleznijo ali demenco z Lewyevimi telesci (DLB), ker imata obe skupini lahko povečano tveganje za pojav nevroleptičnega malignega sindroma in tudi povečano občutljivost na antipsihotike.
English: • inappropriate secretion of a hormone that controls urine volume
Slovenian: • neustrezno sproščanje hormona, ki uravnava količino izločenega urina
English: This study included a 33-week open-label acute treatment and stabilisation phase, a randomised, double-blind placebo-controlled phase to observe for relapse, and a 52-week open-label extension period.
Slovenian: Ta študija je obsegala 33-tedensko odprto akutno zdravljenje in randomizirano, dvojno slepo, s placebom nadzorovano fazo stabilizacije, s čemer so opazovali relapse, ter 52-tedensko odprto podaljšano obdobje.
English: Xeplion is also available in a Treatment initiation pack which contains two pre-filled syringes (150 mg + 100 mg) and 2 additional safety needles.
Slovenian: Zdravilo Xeplion je na voljo tudi v pakiranju za uvedbo zdravljenja, ki vsebuje dve napolnjeni injekcijski brizgi (150 mg + 100 mg) in 2 dodatni varnostni igli.
English: MARKETING AUTHORISATION HOLDER
Slovenian: Authorisation Holder.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom.
English: Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Slovenian: Dodatna klinična znaka sta lahko mioglobinurija (rabdomioliza) in akutna ledvična odpoved.
English: The one-week initiation dosing regimen including the intramuscular injections (day 1 and 8, respectively) as described in section 4.2 above is not required.
Slovenian: Enotedensko uvajalno odmerjanje (intramuskularni injekciji ob dnevih 1 in 8), kot je opisano v poglavju 4.2, ni potrebno.
English: Xeplion should then be continued at monthly intervals.
Slovenian: Potem je treba nadaljevati z injiciranjem zdravila Xeplion v mesečnih presledkih.
English: Xeplion should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Xeplion ne smete uporabljati med nosečnostjo, če ni nujno.
English: Weight should be monitored regularly.
Slovenian: Telesno maso je treba redno spremljati.
English: • life threatening complications of uncontrolled diabetes
Slovenian: • življenjsko nevarni zapleti pri nenadzorovani sladkorni bolezni
English: • swelling of the face, mouth, eyes, or lips, swelling of the body, arms or legs
Slovenian: • otekanje obraza, ust, oči ali ustnic, otekline po telesu, rokah ali nogah
English: Do not store above 30°C.
Slovenian: Zdravilo shranjujte pri temperaturi do 30 °C.
English: While it can involve any part of the body (and may result in abnormal posture), dystonia often involves muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.
Slovenian: Čeprav lahko distonija vključuje kateri koli del telesa (lahko povzroči nenormalno telesno držo), se pogosto pojavi na mišicah obraza, vključno z nenormalnimi gibi očesa, ust, jezika ali čeljusti.
English: Venous thromboembolism
Slovenian: Venski trombembolizem
English: • atrial fibrillation (an abnormal heart rhythm), irregular heart beat
Slovenian: • atrijska fibrilacija (motnje srčnega ritma), nepravilen srčni utrip
English: • inability to pass urine
Slovenian: • nezmožnost odvajanja urina
English: Body mass index (BMI)/body weight
Slovenian: Indeks telesne mase (ITM)/telesna masa
English: Antiemetic effect
Slovenian: Antiemetično delovanje
English: Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face.
Slovenian: Svojega zdravnika takoj obvestite, če se pri vas pojavijo nehoteni ritmični gibi jezika, ust in obraza.
English: - if you are allergic to another antipsychotic medicine including the substance risperidone.
Slovenian: - če ste alergični na drugo antipsihotično zdravilo, ki vsebuje risperidon.
English: Potential for Xeplion to affect other medicines
Slovenian: Možnost, da bo zdravilo Xeplion vplivalo na druga zdravila
English: In vitro studies have shown that paliperidone is a P-gp substrate and a weak inhibitor of P-gp at high concentrations.
Slovenian: Študije in vitro so pokazale, da je paliperidon substrat P-gp in šibek zaviralec P-gp pri velikih koncentracijah.
English: EU/1/11/672/001 (25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg) EU/1/11/672/004 (100 mg)
Slovenian: EU/1/11/672/001(25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg)
English: Refer to ‘Extrapyramidal symptoms' below.
Slovenian: Glejte ‘ekstrapiramidni simptomi' spodaj.
English: The fixed doses of Xeplion in these studies were given on days 1, 8, and 36 in the 9-week study, and additionally on day 64 of the 13-week studies.
Slovenian: V teh študijah so fiksne odmerke zdravila Xeplion dajali 1., 8. in 36. dan v devettedenski študiji, v 13-tedenskih pa še 64. dan.
English: Pharmacokinetic studies with paliperidone palmitate have shown somewhat lower (10-20%) plasma concentrations of paliperidone in patients who are overweight or obese in comparison with normal weight patients (see section 4.2).
Slovenian: Farmakokinetične študije paliperidonijevega palmitata so pokazale nekoliko manjše (10-20%) koncentracije paliperidona v plazmi pri bolnikih s prekomerno telesno maso v primerjavi z bolniki z normalno telesno maso (glejte poglavje 4.2).
English: Leucopenia, neutropenia, and agranulocytosis
Slovenian: Levkopenija, nevtropenija in agranulocitoza
English: • are a man and experience prolonged or painful erection.
Slovenian: • ste moški in se pri vas pojavi boleča ali dolgotrajna erekcija, ki se imenuje priapizem.
English: Paliperidone binds strongly to serotonergic 5-HT2and dopaminergic D2-receptors.
Slovenian: Paliperidon se močno veže na serotoninske receptorje 5-HT2 in dopaminske receptorje D2.
English: They were either derived from spontaneous post-marketing reports and frequency cannot be determined, or they were derived from risperidone (any formulation) or oral paliperidone clinical trials data and/or post-marketing reports.
Slovenian: Izhajajo iz spontanih poročil v obdobju trženja in njihove pogostnosti ni mogoče določiti, ali iz podatkov kliničnih preskušanj in/ali poročil v obdobju trženja z risperidonomn (katera koli oblika) ali peroralnim paliperidonom.
English: Since no effect on the systemic clearance was observed, a clinically significant interaction would not be expected between divalproex sodium prolonged release tablets and Xeplion intramuscular injection.
Slovenian: Ker niso opazili nobenega učinka na sistemski očistek, ne pričakujejo klinično pomembne interakcije med tabletami natrijevega divalproeksa s podaljšanim sproščanjem in intramuskularno injiciranim zdravilom Xeplion.
English: How to use Xeplion
Slovenian: Kako uporabljati zdravilo Xeplion
English: See section 4.2 for information on paediatric use.
Slovenian: Za informacije o uporabi pri pediatrični populaciji glejte poglavje 4.2.
English: Paliperidone is a selective blocking agent of monoamine effects, whose pharmacological properties are different from that of traditional neuroleptics.
Slovenian: Paliperidon je selektiven zaviralec učinkov monoaminov in njegove farmakološke lastnosti se razlikujejo od lastnosti klasičnih nevroleptikov.
English: A population pharmacokinetic analysis based on data with oral paliperidone prolonged release tablets showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Slovenian: Analiza farmakokinetike populacije podatkov na osnovi peroralnega paliperidon v obliki tablet s podaljšanim sproščanjem je pokazala nekoliko manjšo izpostavljenost paliperidonu pri kadilcih kot pri nekadilcih.
English: The release profile and dosing regimen of Xeplion results in sustained therapeutic concentrations.
Slovenian: Mehanizem sproščanja in režim odmerjanja zdravila Xeplion zagotavljata vzdrževanje terapevtskih koncentracij.
English: • fast, shallow breathing, pneumonia caused by inhaling food, voice disorder
Slovenian: • hitro, plitvo dihanje, pljučnica, povzročena z vdihnjeno hrano, motnje glasu
English: Potential for other medicines to affect Xeplion
Slovenian: Možnost, da bodo druga zdravila vplivala na zdravilo Xeplion
English: • very low body temperature, chills, feeling thirsty
Slovenian: • zelo nizka telesna temperatura, mrazenje, občutek žeje
English: The potential benefit of stopping alpha 1 blocking therapy prior to cataract surgery has not been established and must be weighed against the risk of stopping the antipsychotic therapy.
Slovenian: Možnih koristi ukinitve zdravljenja z zaviralci receptorjev alfa-1 pred operacijo sive mrene niso ugotovili in jih je treba pretehtati glede na tveganja ob ukinitvi antipsihotičnega zdravljenja.
English: • coma due to uncontrolled diabetes
Slovenian: • koma zaradi neurejene sladkorne bolezni
English: Paliperidone also blocks alpha 1-adrenergic receptors and slightly less, H1-histaminergic and alpha 2-adrenergic receptors.
Slovenian: Paliperidon zavira tudi adrenergične receptorje alfa-1 in v manjši meri tudi histaminske receptorje H1 in adrenergične receptorje alfa-2.
English: • increase in eosinophils (a type of white blood cell) in your blood
Slovenian: • povečano število eozinofilcev (vrste belih krvnih celic) v krvi
English: On initiation of carbamazepine, the dose of Xeplion should be re-evaluated and increased if necessary.
Slovenian: Ob uvajanju karbamazepina je treba odmerek zdravila Xeplion ponovno oceniti in ga po potrebi povečati.
English: However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death (see section 4, possible side effects).
Slovenian: Pri starejših bolnikih z demenco, ki so jih zdravili s podobnimi zdravili, je tveganje za možgansko kap in smrt povečano (glejte poglavje 4, Možni neželeni učinki).
English: If hypersensitivity reactions occur, discontinue use of Xeplion; initiate general supportive measures as clinically appropriate and monitor the patient until signs and symptoms resolve (see sections 4.3 and
Slovenian: Če se pojavi anafilaktična reakcija je treba zdravljenje z zdravilom Xeplion prekiniti in uvesti klinično primerne splošne podporne ukrepe, bolnike pa skrbno spremljati dokler znaki in simptomi ne izzvenijo (glejte poglavji 4.3 in 4.8).
English: No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Slovenian: Podatkov o uporabi pri bolnikih s hudo okvaro jeter ni (razred C po Child-Pughovi lestvici).
English: Inject the entire contents intramuscularly slowly, deep into the selected deltoid or gluteal muscle of the patient.
Slovenian: Celotno vsebino intramuskularno injicirajte počasi, globoko v izbrano deltoidno ali glutealno mišico bolnika.
English: • are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
Slovenian: • če načrtujete operacijo na očesu, okulistu ne pozabite povedati, da prejemate to zdravilo.
English: Adverse reactions that may suggest increase in prolactin levels (e.g., amenorrhoea, galactorrhoea, menstrual disturbances, gynaecomastia) were reported overall in < 1% of subjects.
Slovenian: O neželenih pojavih, ki bi lahko bili povezani s prolaktinom (amenoreja, galaktoreja, motnje menstruacije, ginekomastija) pa so poročali pri skupaj < 1% preiskovancev.
English: Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur.
Slovenian: Pri bolnikih s klinično pomembno nevtropenijo je treba skrbno spremljati pojav povišane telesne temperature ali drugih simptomov in znakov okužbe in jih zdraviti takoj, ko se pojavijo.
English: • glaucoma (increased pressure within the eyeball)
Slovenian: • glavkom (povišan tlak v notranjosti očesa)
English: Administration should be made into the upper-outer quadrant of the gluteal area.
Slovenian: Zdravilo je treba injicirati v zgornji zunanji kvadrant glutealnega območja.
English: - if you have Parkinson's disease - if you have ever been diagnosed with a condition whose symptoms include high temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome) - if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia) - if you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines) - if you are diabetic or prone to diabetes - if you have had breast cancer or a tumour in the pituitary gland in your brain - if you have a heart disease or heart disease treatment that makes you prone to low blood pressure - if you have low blood pressure when you stand up or sit up suddenly - if you have epilepsy - if you have kidney problems - if you have liver problems - if you have prolonged and/or painful erection - if you have problems with controlling core body temperature or overheating - if you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour - if you or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.
Slovenian: - če imate Parkinsonovo bolezen - če so vam kdaj diagnosticirali stanje s simptomi kot sta povišana telesna temperatura in mišična okorelost (znano tudi kot nevroleptični maligni sindrom) - če so se pri vas kadar koli pojavili nenormalni gibi jezika in obraza (tardivna diskinezija) - če ste že imeli majhno število belih krvnih celic (ki bi jo lahko ali ne povzročilo drugo zdravilo) - če imate sladkorno bolezen ali ste nagnjeni k sladkorni bolezni - če ste imeli raka dojke ali tumor hipofize v možganih - če imate srčno bolezen ali se zdravite za srčne bolezni in ste zato nagnjeni k nizkemu krvnemu tlaku - če imate nizek krvni tlak, kadar nenadoma vstanete ali se usedete iz ležečega položaja - če imate epilepsijo - če imate težave z ledvicami - če imate težave z jetri - če imate podaljšano in/ali bolečo erekcijo - če imate težave z nadzorovanjem telesne temperature ali se hitro pregrejete - če imate nenormalno visoke koncentracije hormona prolaktina v krvi ali imate tumor, ki je odvisen od prolaktina - če ste imeli vi ali kdo drug v vaši družini krvne strdke, saj je jemanje antipsihotikov povezano z nastankom krvnih strdkov
English: akathisia c, sedation/somnolence, dystonia c, dizziness, dyskinesia c, tremor,
Slovenian: akatizija c, sedacija/somnolenca, distonija c, omotičnost, diskinezija c, tremor,
English: • incontinence (lack of control) of urine, frequent passing of urine, pain when passing urine
Slovenian: • uhajanje urina (nezmožnost nadzora), pogosto uriniranje, bolečine pri uriniranju
English: • increased liver transaminases in your blood
Slovenian: • povišane koncentracije jetrnih transaminaz v krvi
English: • restlessness, feeling sleepy, or less alert
Slovenian: • nemir, občutek zaspanosti ali zmanjšana pozornost
English: Conversely, on discontinuation of carbamazepine, the dose of Xeplion should be re-evaluated and decreased if necessary.
Slovenian: Ob prekinitvi karbamazepina je treba odmerek zdravila Xeplion ponovno oceniti in po potrebi zmanjšati.
English: Xeplion should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Slovenian: Pri sočasni uporabi zdravila Xeplion z zdravili, ki povečajo aktivnost centralnega živčnega sistema (psihostimulansi, kot je metilfenidat), je potrebna previdnost.
English: Intramuscularly injected paliperidone palmitate and orally administered paliperidone were not teratogenic in animal studies, but other types of reproductive toxicity were seen (see section 5.3).
Slovenian: V študijah na živalih intramuskularno injicirani paliperidonijev palmitat in peroralni paliperidon nista bila teratogena, opazili pa so druge vrste reprodukcijske toksičnosti (glejte poglavje 5.3).
English: Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are metabolised by cytochrome P-450 isozymes.
Slovenian: Ni pričakovati, da bi paliperidon povzročil klinično pomembne farmakokinetične interakcije z zdravili, ki se presnavljajo preko citokroma P-450.
English: Discontinuation of antipsychotic medicinal products should be made in accordance with appropriate prescribing information.
Slovenian: Zdravljenje z antipsihotičnim zdravilom je treba prekiniti skladno z navodilom za predpisovanje zadevnega zdravila.
English: Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.
Slovenian: Čeprav v kliničnih in epidemioloških študijah do zdaj niso ugotovili jasne povezave z uporabo antipsihotikov, pri bolnikih z ustrezno anamnezo priporočamo previdnost.
English: • sensation of spinning (vertigo), ringing in the ears, ear pain
Slovenian: • občutek vrtenja (vrtoglavica), zvonenje v ušesih, bolečina v ušesu
English: Patients who have been given too much paliperidone may experience the following symptoms: drowsiness or sedation, fast heart rate, low blood pressure, an abnormal electrocardiogram (electrical tracing of the heart), or slow or abnormal movements of the face, body, arms or legs.
Slovenian: Pri bolnikih, ki so jim dali prevelik odmerek paliperidona, se lahko pojavijo naslednji simptomi: zaspanost ali sedacija, hiter srčni utrip, nizek krvni tlak, nenormalen elektrokardiogram (električno spremljanje delovanja srca) ali počasno in nenormalno premikanje obraza, telesa, rok ali nog.
English: Also, the iris (the coloured part of the eye) may become floppy during surgery and that may lead to eye damage.
Slovenian: Tudi šarenica (obarvani del očesa) lahko med operacijo postane ohlapna in to lahko povzroči poškodbo očesa.
English: This interaction has not been studied with Xeplion.
Slovenian: Te interakcije z zdravilom Xeplion niso preučevali.
English: In a meta-analysis of 17 controlled clinical trials, elderly patients with dementia treated with other atypical antipsychotics, including risperidone, aripiprazole, olanzapine, and quetiapine had an increased risk of mortality compared to placebo.
Slovenian: V metaanalizi 17 nadzorovanih kliničnih preskušanj so pri starejših bolnikih z demenco, zdravljenih z drugimi atipičnimi antipsihotiki, vključno z risperidonom, aripiprazolom, olanzapinom in kvetiapinom, ugotovili povečano tveganje za smrt v primerjavi s placebom.
English: • leakage of milk from the breasts
Slovenian: • iztekanje mleka iz dojk
English: A total of 410 stabilised patients were randomised to either Xeplion (median duration 171 days [range 1 day to 407 days]) or to placebo (median duration 105 days [range 8 days to 441 days]) until they experienced a relapse of schizophrenia symptoms in the variable length double-blind phase.
Slovenian: Skupno 410 stabiliziranih bolnikov so naključno razporedili v skupino, ki je prejemala zdravilo Xeplion (mediana trajanja 171 dni [razpon od 1 dneva do 407 dni]), ali v skupino, ki je prejemala placebo (mediana trajanja 105 dni [razpon od 8 dni do 441 dni]), dokler ni prišlo do relapsa simptomov shizofrenije v različno dolgi dvojno slepi fazi.
English: However, because elderly patients may have diminished renal function, dose adjustment may be necessary (see Renal impairment below for dosing recommendations in patients with renal impairment).
Slovenian: Ker imajo lahko starejši bolniki poslabšano delovanje ledvic, bo morda treba prilagoditi odmerek (za priporočeno odmerjanje pri bolnikih s poslabšanim delovanjem ledvic glejte Ledvična okvara spodaj).
English: Caution should be exercised when paliperidone is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QT interval.
Slovenian: Pri predpisovanju paliperidona bolnikom z znano srčnožilno boleznijo ali s podaljšanjem intervala QT v družinski anamnezi ter pri njegovi sočasni uporabi z drugimi zdravili, ki tudi podaljšajo interval QT, je potrebna previdnost.
English: If the target date for the second Xeplion injection (day 8 ± 4 days) is missed, the recommended reinitiation depends on the length of time which has elapsed since the patient's first injection.
Slovenian: Če zamudimo ciljni datum za drugo injiciranje zdravila Xeplion (8. dan ± 4 dni), je priporočeno ponovno uvajanje odvisno od časa, ki je pretekel od prvega injiciranja.
English: Dominating central serotonin antagonism may reduce the tendency of paliperidone to cause extrapyramidal side effects.
Slovenian: Dominantni antagonizem serotonina v osrednjem živčevju lahko zmanjša nagnjenost paliperidona k povzročanju ekstrapiramidnih neželenih učinkov.
English: • cough, stuffy nose
Slovenian: • kašelj, zamašen nos
English: In a study with oral paliperidone in subjects with moderate hepatic impairment (Child-Pugh class B), the plasma concentrations of free paliperidone were similar to those of healthy subjects.
Slovenian: V študiji peroralnega paliperidona pri preizkušancih z zmerno okvaro jeter (razred B po Child-Pughovi lestvici) so bile koncentracije prostega paliperidona v plazmi podobne kot pri zdravih preizkušancih.
English: In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone's known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms.
Slovenian: Na splošno lahko pričakujemo znake in simptome, ki so posledica prekomernih farmakoloških učinkov paliperidona, to so zaspanost in sedacija, tahikardija, hipotenzija, podaljšanje intervala QT in ekstrapiramidni simptomi.
English: The carcinogenic potential of intramuscularly injected paliperidone palmitate was assessed in rats.
Slovenian: Kancerogenost intramuskularno injiciranega paliperidonijevega palmitata so ocenili pri podganah.
English: Agranulocytosis has been reported very rarely (< 1/10,000 patients) during post-marketing surveillance.
Slovenian: O agranulocitozi, so v obdobju po pridobitvi dovoljenja za promet, poročali zelo redko (< 1/10.000 bolnikov).
English: Some patients switching from higher paliperidone oral doses (e.g., 9-12 mg daily) to gluteal injections with Xeplion may have lower plasma exposure during the first 6 months after the switch.
Slovenian: Pri nekaterih bolnikih, ki preidejo z večjih odmerkov peroralnega paliperidona (tj. 9-12 mg na dan) na injiciranje zdravila Xeplion v glutealno mišico, lahko pride v prvih 6 mesecih po menjavi do manjše plazemske izpostavljenosti.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: • an increase in body temperature
Slovenian: • povišanje telesne temperature
English: Based on a limited number of observations with Xeplion in subjects with mild renal impairment and pharmacokinetic simulations, a reduced dose is recommended (see section 4.2).
Slovenian: Zaradi majhnega števila podatkov o zdravilu Xeplion pri preiskovancih z blago okvaro ledvic in farmakokinetičnih simulacij je priporočeno zmanjšanje odmerka (glejte poglavje 4.2).
English: If you notice any of these symptoms seek medical advice immediately.
Slovenian: Če opazite katerega od teh simptomov, takoj poiščite zdravniško pomoč.