natgillin/translations-raw huggingface dataset:
Doses of risperidone long acting injection and Xeplion needed to attain similar paliperidone exposure at steady-state
Odmerki dolgodelujočega injiciranega risperidona in zdravila Xeplion, potrebni za doseganje podobne izpostavljenosti paliperidonu v stanju dinamičnega ravnovesja
Paliperidone should be used with caution in patients with a pre-existing tumour that may be prolactin-dependent.
Pri bolnikih s predhodno prisotnimi tumorji, ki bi lahko bili odvisni od prolaktina je treba paliperidon uporabljati previdno.
Xeplion is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min) (see section 4.4).
Pri bolnikih z zmerno ali hudo okvaro ledvic (očistek kreatinina < 50 ml/min) ne priporočamo uporabe zdravila Xeplion (glejte poglavje 4.4).
The Xeplion maintenance doses needed to attain similar steady-state exposure are shown as follows:
Vzdrževalni odmerki zdravila Xeplion, potrebni za doseganje podobne izpostavljenosti v stanju dinamičnega ravnovesja, so:
Blood and lymphatic system disorders white blood cell count decreased, thrombocytopenia, anaemia neutropenia, eosinophil count increased agranulocytosis
Bolezni krvi in limfatičnega sistema zmanjšano število levkocitov, trombocitopenija, anemija nevtropenija, povečano število eozinofilcev agranulocitoza
Elderly Your doctor may reduce your dose of this medicine if your kidney function is reduced.
Starejši Če imate zmanjšano ledvično funkcijo, vam bo zdravnik morda zmanjšal odmerek tega zdravila.
Missed second initiation dose (4-7 weeks from first injection) If 4 to 7 weeks have elapsed since the first injection of Xeplion, resume dosing with two injections of 100 mg in the following manner: a deltoid injection as soon as possible another deltoid injection one week later resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy.
Spuščen drugi uvajalni odmerek (4-7 tednov od prvega injiciranja) Če je od prvega injiciranja zdravila Xeplion preteklo od 4 do 7 tednov, nadaljujte odmerjanje z dvema injiciranjema 100 mg na naslednji način: čim prejšnje injiciranje v deltoidno mišico, ponovno injiciranje v deltoidno mišico po enem tednu, vzpostavite normalen mesečni cikel injiciranja vzdrževalnih odmerkov od 25 do 150 mg v deltoidno ali glutealno mišico.
Metabolism and nutrition disorders hyperglycaemia, weight increased, weight decreased, decreased appetite diabetes mellitus d, hyperinsulinaemia, increased appetite, anorexia, blood triglycerides increased, blood cholesterol increased diabetic ketoacidosis, hypoglycaemia, polydipsia water intoxication
Presnovne in prehranske motnje hiperglikemija, povečanje telesne mase, zmanjšanje telesne mase, zmanjšan apetit sladkorna bolezen d, hiperinsulinemija, povečan apetit, anoreksija, povečana koncentracija trigliceridov v krvi, povečana koncentracija holesterola v krvi diabetična ketoacidoza e, hipoglikemija, polidipsija zastrupitev z vodo
Patients previously stabilised on different doses of risperidone long acting injection can attain similar paliperidone steady-state exposure during maintenance treatment with Xeplion monthly doses according to the following:
Bolniki, stabilizirani na različnih odmerkih dolgodelujoče injekcije risperidona, lahko med vzdrževalnim zdravljenjem z mesečnimi odmerki zdravila Xeplion dosežejo podobno izpostavljenost paliperidonu v stanju dinamičnega ravnovesja, pri čemer je treba upoštevati naslednje:
Paliperidone is not extensively metabolised in the liver.
Paliperidon se v jetrih presnavlja v manjšem obsegu.
Hyperglycaemia, diabetes mellitus, and exacerbation of pre-existing diabetes including diabetic coma and ketoacidosis, have been reported during treatment with paliperidone.
Med zdravljenjem s paliperidonom so poročali o hiperglikemiji, sladkorni bolezni in poslabšanju že predhodno prisotne sladkorne bolezni, vključno z diabetično komo in ketoacidozo.
Patients with kidney problems
Bolniki z okvaro ledvic
Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Poleg ekstrapiramidnih simptomov lahko med znake povečane občutljivosti sodijo zmedenost, otopelost in nestabilna drža s pogostimi padci.
Xeplion 150 mg and Xeplion 100 mg prolonged release suspension for injection
Xeplion 150 mg in Xeplion 100 mg suspenzija za injiciranje s podaljšanim sproščanjem
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth,
• neprijeten občutek v trebuhu, okužba želodca ali črevesja, oteženo požiranje, suha usta
EU/1/11/672/005 (150 mg)
EU/1/11/672/004 (100 mg) EU/1/11/672/005 (150 mg)
Anaphylactic reactions in patients who have previously tolerated oral risperidone or oral paliperidone have been rarely reported during post-marketing experience (see sections 4.1 and 4.8).
V obdobju trženja so pri bolnikih, ki so dobro prenašali peroralni risperidon ali peroralni paliperidon, poročali o redkih primerih anafilaktične reakcije (glejte poglavji 4.1 in 4.8).
Consideration should be given to the prolonged release nature of the medicinal product and the long elimination half-life of paliperidone when assessing treatment needs and recovery.
Pri oceni potrebe po zdravljenju in bolnikovega okrevanja je treba upoštevati podaljšano sproščanje zdravila in dolg razpolovni čas paliperidona.
Pre-filled syringe (cyclic-olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm).
Napolnjena injekcijska brizga (kopolimer cikloolefina) z batom in vrhnjo zaporko (iz bromobutilne gume) ter varnostna igla velikosti 0,72 mm x 38,1 mm (1½ palca, velikost 22) in varnostna igla velikosti 0,64 mm x 25,4 mm (1 palec, velikost 23).
The recommended needle size for maintenance administration of Xeplion into the gluteal muscle is the 1½-inch, 22 gauge needle (38.1 mm x 0.72 mm).
Priporočena velikost igle za vzdrževalno injiciranje zdravila Xeplion v glutealno mišico je 38,1 mm x 0,72 mm (1½ palca, velikost 22).
12 mg daily
12 mg na dan
Each pack contains 2 pre-filled syringes:
Ena škatla vsebuje 2 napolnjeni injekcijski brizgi.
No embryotoxicity or malformations were observed following intramuscular administration of paliperidone palmitate to pregnant rats up to the highest dose (160 mg/kg/day) corresponding to 4.1 times the exposure level in humans at the maximum recommended dose of 150 mg. Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring.
Po intramuskularnem injiciranju paliperidonijevega palmitata brejim podganam, pri čemer je bil največji odmerek (160 mg/kg/dan), kar ustreza 4,1-kratni izpostavljenosti pri največjem priporočenem odmerku (150 mg) pri človeku, niso opazili toksičnosti za zarodek ali malformacij.
Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leucopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of Xeplion should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Bolnike, ki so že imeli klinično pomembno nizko število levkocitov (WBC) ali z zdravilom izzvano levkopenijo/nevtropenijo je treba skrbno spremljati prve mesece zdravljenja.
PRE-FILLED SYRINGE
Sindrom ohlapne šarenice
Peel the safety needle blister pouch half way open.
Pretisni omot z varnostno iglo odprite napol.
Deltoid injections should be alternated between the two deltoid muscles.
Oba odmerka se injicirata v deltoidno mišico.
The suspension is white to off-white.
suspenzija za injiciranje s podaljšanim sproščanjem Suspenzija je bela do sivkastobela.
Infections and infestations upper respiratory tract infection, urinary tract infection, influenza pneumonia, bronchitis, respiratory tract infection, sinusitis, cystitis, ear infection, tonsillitis, onychomycosis, cellulitis eye infection, acarodermatitis, subcutaneous abscess
Infekcijske in parazitske bolezni okužba zgornjih dihal, okužba sečil, gripa pljučnica, bronhitis, okužba dihal, sinuzitis, cistitis, okužba ušesa, tonzilitis, onihomikoza, celulitis okužba očesa, akarodermatitis, podkožni absces
Caution is advised if paliperidone is combined with other medicinal products known to lower the seizure threshold (i.e., phenothiazines or butyrophenones, tricyclics or SSRIs, tramadol, mefloquine, etc.).
Če se paliperidon uporablja sočasno z zdravili, ki znižajo prag za epileptične napade (ko so fenotiazini ali butirofenoni, triciklični antidepresivi ali selektivni zaviralci ponovnega privzema serotonina (SSRI), tramadol meflokin itd.), je potrebna previdnost.
Based on experience with oral paliperidone, no dose adjustment is required in patients with mild or moderate hepatic impairment.
Na podlagi izkušenj s peroralnim paliperidonom pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati.
Priapism
Priapizem
Subject evaluations of injection site pain based on a visual analogue scale tended to lessen in frequency and intensity over time in all Phase 2 and 3 studies with Xeplion.
V vseh študijah faze 2 in 3 z zdravilom Xeplion se je pogostnost in intenzivnost bolečine na mestu injiciranja, ki so jo ocenjevali z vizualno analogno skalo (VAS), sčasoma zmanjšala.
Although in vitro studies suggested a role for CYP2D6 and CYP3A4 in the metabolism of paliperidone, there is no evidence in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Čeprav študije in vitro kažejo da pri presnovi paliperidona sodelujeta tudi encima CYP2D6 in CYP3A4, in vivo ni dokazov, da bi ta dva izoencima imela pomembno vlogo pri presnovi paliperidona.
• inflammation of the pancreas, swollen tongue, stool incontinence, very hard stool
• vnetje trebušne slinavke, otečen jezik, nezmožnost zadrževanja blata, zelo trdo blato
• shortness of breath, congestion of breathing passages, wheezing, sore throat, nosebleeds
• zadihanost, zapora dihalnih poti, piskajoče dihanje, vnetje grla, krvavitev iz nosu
Hepatobiliary disorders transaminases increased gammaglutamyltransferase increased, hepatic enzyme increased jaundice
povečana koncentracija gamaglutamil transferaze, zvičaane koncentracije jetrnih encimov zlatenica
The adverse drug reactions (ADRs) most frequently reported in clinical trials were insomnia, headache, anxiety, upper respiratory tract infection, injection site reaction, parkinsonism, weight increased, akathisia, agitation, sedation/somnolence, nausea, constipation, dizziness, musculoskeletal pain, tachycardia, tremor, abdominal pain, vomiting, diarrhoea, fatigue, and dystonia.
Najpogostejši neželeni učinki, o katerih so poročali v kliničnih preskušanjih, so bili nespečnost, glavobol, anksioznost, okužba zgornjih dihal, reakcija na mestu injiciranja, parkinsonizem, povečana telesna masa, akatizija, agitacija, sedacija/somnolenca, navzea, obstipacija, omotica, mišično-skeletna bolečina, tahikardija, tremor, bolečina v trebuhu, bruhanje, driska, utrujenost in distonija.
While holding the syringe upright, remove the rubber tip cap with a twisting motion.
Brizgo držite pokončno, gumijasto vrhnjo zaporko odstranite tako, da jo odvijete.
Missed doses
Spuščeni odmerki
Insomnia includes: initial insomnia, middle insomnia; Convulsion includes: grand mal convulsion; Oedema includes: generalised oedema, oedema peripheral, pitting oedema.
Nespečnost vključuje: težave ob uspavanju, prebujanje ponoči; Konvulzije vključujejo: konvulzije tipa grand mal; Edem vključuje: generaliziran edem, periferni edem, testasti edem; Motnje menstruacije vključujejo:zapoznelo menstruacijo, neredne menstruacije, oligomenorejo.
The frequency of these adverse reactions is qualified as “not known” because they were not observed in paliperidone palmitate clinical trials.
O pogostnosti naslednjih neželenih učinkov paliperidona so poročali v kliničnih preskušanjih paliperidonijevega palmitata.
If the patient is being switched from risperidone long acting injection to Xeplion, the first injection of Xeplion (ranging from 25 mg to 150 mg) can be administered in either the DELTOID or GLUTEAL muscle using the appropriate needle for the injection site at the time of the next scheduled injection.
Če bolnik preide z dolgodelujoče injekcije risperidona na zdravilo Xeplion, lahko ob naslednjem načrtovanem injiciranju prejme prvo injekcijo zdravila Xeplion (v odmerkih od 25 mg do 150 mg) v DELTOIDNO ali v GLUTEALNO mišico, pri čemer je treba uporabiti pravo iglo za mesto injiciranja.
Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in patients treated with medicinal products with alpha 1a-adrenergic antagonist effect, such as Xeplion (see section 4.8).
Pri bolnikih, zdravljenih z zdravili z antagonističnim učinkom na receptorje alfa-1a, kakršno je tudi zdravilo Xeplion (glejte poglavje 4.8), so med operacijo sive mrene opazili sindrom ohlapne šarenice (IFIS).
• high blood sugar, weight gain, weight loss, decreased appetite
• visoka koncentracija sladkorja v krvi, povečanje telesne mase, zmanjšanje telesne mase,
• chest pain, chest discomfort, feeling unwell
• bolečina v prsnem košu, neprijeten občutek v prsnem košu, slabo počutje
• severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure
obraza, ustnic ali jezika, zasoplost, srbenje, kožni izpuščaj in včasih padec krvnega tlaka
Uncommon side effects: may affect up to 1 in 100 people
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
Pull the needle sheath away from the needle with a straight pull.
Pokrovček igle potegnite z igle.
Renal and urinary disorders urinary incontinence, pollakiuria, dysuria urinary retention
Bolezni sečil inkontinenca urina, polakiuria, disurija zastoj urina
Each Xeplion 100 mg pre-filled syringe contains 156 mg paliperidone palmitate.
Ena 100 mg napolnjena injekcijska brizga zdravila Xeplion vsebuje 156 mg paliperidonijevega palmitata.
No additional oral antipsychotic supplementation was needed during the acute treatment of schizophrenia with Xeplion.
Med akutnim zdravljenjem shizofrenije z zdravilom Xeplion ni bilo treba dodajati drugih peroralnih antipsihotikov.
During post-marketing surveillance, priapism has also been reported with oral paliperidone, which is the active metabolite of risperidone.
O pojavu priapizma so poročali tudi v postmarketinški uporabi peroralnega paliperidona.
These may be signs of a stroke.
To so lahko znaki možganske kapi.
The pack contains a pre-filled syringe and 2 safety needles (a 1½-inch 22 gauge needle [38.1 mm x 0.72 mm] and a 1-inch 23 gauge needle [25.4 mm x 0.64 mm]) for intramuscular injection.
Pakiranje vsebuje napolnjeno injekcijsko brizgo in 2 varnostni igli (velikosti 38,1 mm x 0,72 mm (1½ palca, velikost 22) in velikosti 25,4 mm x 0,64 mm (1 palec, velikost 23)) za intramuskularno injiciranje.
Administration should be in a single injection.
Opravi naj se kot enkratno injiciranje.
Significant weight gain has been reported with Xeplion use.
Pri uporabi zdravila Xeplion so poročali o pomembnem povečanju telesne mase.
Each Xeplion 150 mg pre-filled syringe contains 234 mg paliperidone palmitate.
Ena 150 mg napolnjena injekcijska brizga zdravila Xeplion vsebuje 234 mg paliperidonijevega palmitata.
9 mg daily
9 mg na dan
It should be inspected visually for foreign matter before administration.
Pred uporabo jo je treba pregledati in preveriti, ali so v njej tujki.
Previous risperidone long acting injection dose
Predhodni odmerek injiciranega dolgodelujočega risperidona
An approximately 3-fold increased risk of cerebrovascular adverse reactions has been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics, including risperidone, aripiprazole, and olanzapine.
V randomiziranih, s placebom nadzorovanih kliničnih preskušanjih populacije z demenco, zdravljene z nekaterimi atipičnimi antipsihotiki, vključno z risperidonom, aripiprazolom in olanzapinom, so opazili približno 3-krat povečanje tveganja za možganskožilne neželene učinke.
Skin and subcutaneous tissue disorders urticaria, pruritus, rash, alopecia, eczema, dry skin, erythema, acne drug eruption, hyperkeratosis, dandruff angioedema, skin discolouration, seborrhoeic dermatitis
Bolezni kože in podkožja urtikarija, srbenje, izpuščaj, alopecija, ekcem, suha koža, eritem, akne medikamentozni izpuščaj, hiperkeratoza, prhljaj angioedem, sprememba barve kože, seboreični dermatitis
During monthly maintenance treatment with Xeplion, patients previously stabilised on different doses of paliperidone prolonged release tablets can attain similar paliperdone steady-state exposure by injection.
Bolniki, ki so bili predhodno stabilizirani z različnimi odmerki tablet paliperidona s podaljšanim sproščanjem, lahko z mesečnim vzdrževalnim zdravljenjem z injekcijo zdravila Xeplion dosežejo podobno izpostavljenost paliperidonu v stanju dinamičnega ravnovesja.
Musculoskeletal and connective tissue disorders musculoskeletal pain, back pain, arthralgia blood creatine phosphokinase increased, muscle spasms, joint stiffness, muscular weakness, neck pain rhabdomyolysis, joint swelling posture abnormal
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišično-skeletna bolečina, bolečine v hrbtu, artralgija povečana koncentracija kreatin fosfokinaze v krvi, mišični krči, otrdelost sklepov, šibkost mišic, bolečine v vratu rabdiomioliza, otekanje sklepov nenormalna telesna drža
Since paliperidone is the major active metabolite of risperidone, caution should be exercised when Xeplion is co-administered with risperidone or with oral paliperidone for extended periods of time.
Paliperidon je glavni aktivni presnovek risperidona, zato je pri daljši sočasni uporabi zdravila Xeplion in risperidona ali peroralnega paliperidona potrebna previdnost.
Common side effects: may affect up to 1 in 10 people
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
Deltoid muscle administration
Injiciranje v deltoidno mišico
Xeplion should be used with caution in elderly patients with dementia with risk factors for stroke.
Pri starejših bolnikih z demenco in dejavniki tveganja za možgansko kap je treba zdravilo Xeplion uporabljati previdno.
Each Xeplion 75 mg pre-filled syringe contains 117 mg paliperidone palmitate.
Ena 75 mg napolnjena injekcijska brizga zdravila Xeplion vsebuje 117 mg paliperidonijevega palmitata.
Xeplion should not be used while breast-feeding.
Med dojenjem matere ne smejo jemati zdravila Xeplion.
Switching from oral prolonged release paliperidone or oral risperidone to Xeplion Xeplion should be initiated as described at the beginning of section 4.2 above.
Zdravilo Xeplion je treba uvesti, kot je opisano zgoraj, na začetku poglavja 4.2.
• sleep walking
• hoja med spanjem
Respiratory, thoracic and mediastinal disorders cough, nasal congestion dyspnoea, respiratory tract congestion, wheezing, pharyngolaryngeal pain, epistaxis sleep apnoea syndrome, pulmonary congestion, rales hyperventilation, pneumonia aspiration, dysphonia
Bolezni dihal, prsnega koša in mediastinalneg a prostora kašelj, kongestija nosne sluznice dispneja, kongestija dihalnih poti, sopihanje, faringolaringealna bolečina, epistaksa sindrom apneje v spanju, pljučna kongestija, piskajoče dihanje hiperventilacija, aspiracijska pljučnica, disfonija
Avoiding missed doses
Preprečevanje spuščenih odmerkov
For patients stabilised with 150 mg a deltoid injection as soon as possible at the 100 mg dose another deltoid injection one week later (day 8) at the 100 mg dose resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy.
Za bolnike, stabilizirane z odmerkom 150 mg čim prejšnje injiciranje odmerka 100 mg v deltoidno mišico, drugo injiciranje 100 mg v deltoidno mišico po enem tednu (8. dan), vzpostavitev normalnega mesečnega injiciranja vzdrževalnih odmerkov od 25 do 150 mg v deltoidno ali glutealno mišico.
In the 13-week study involving the 150 mg initiation dosing, the proportion of subjects with an abnormal weight increase ≥ 7% showed a dose-related trend, with a 5% incidence rate in the placebo group compared with rates of 6%, 8% and 13% in the Xeplion 25 mg, 100 mg, and 150 mg groups, respectively.
Incidenca povečanja telesne mase v skupini, ki je prejemala placebo je bila 5% ter 6, 8 in 13% v skupinah, ki so prejemale zdravilo Xeplion v odmerku 25, 100 oziroma 150 mg.
The mean steady-state peak:trough ratio for a Xeplion dose of 100 mg was 1.8 following gluteal administration and 2.2 following deltoid administration.
Povprečno razmerje med najvišjo in najnižjo koncentracijo v stanju dinamičnega ravnovesja pri 100 mg odmerku zdravila Xeplion je bilo po injiciranju v glutealno mišico 1,8, v deltoidno pa 2,2.
Each pre-filled syringe contains 234 mg paliperidone palmitate equivalent to 150 mg paliperidone.
Ena napolnjena injekcijska brizga vsebuje 234 mg paliperidonijevega palmitata v količini, ki ustreza 150 mg paliperidona.
Xeplion 150 mg: Each pre-filled syringe contains paliperidone palmitate equivalent to 150 mg paliperidone.
Xeplion 150 mg: Ena napolnjena injekcijska brizga vsebuje paliperidonijev palmitat v količini, ki ustreza 150 mg paliperidona.
Each pre-filled syringe contains 156 mg paliperidone palmitate equivalent to 100 mg paliperidone.
Ena napolnjena injekcijska brizga vsebuje 156 mg paliperidonijevega palmitata v količini, ki ustreza 100 mg paliperidona.
Do not use if the syringe is not visually free of foreign matter.
Ne uporabite, če brizga vsebuje tujke.
Xeplion 100 mg: Each pre-filled syringe contains paliperidone palmitate equivalent to 100 mg paliperidone.
Xeplion 100 mg: Ena napolnjena injekcijska brizga vsebuje paliperidonijev palmitat v količini, ki ustreza 100 mg paliperidona.
Doses of paliperidone prolonged release tablets and Xeplion needed to attain similar steadystate paliperidone exposure during maintenance treatment Previous paliperidone prolonged release tablet dose
Odmerki tablet paliperidona s podaljšanim sproščanjem in zdravila Xeplion, potrebni za doseganje podobne izpostavljenosti paliperidonu v stanju dinamičnega ravnovesja, med vzdrževalnim zdravljenjem
Attach the safety needle to the luer connection of the syringe with an easy clockwise twisting motion.
Varnostno iglo priključite na luer nastavek na brizge tako, da jo zavrtite v smeri urinega kazalca.
Subjects initially received flexible doses (25-100 mg) of Xeplion during a 9-week transition period, followed by a 24-week maintenance period, where subjects were required to have a PANSS score of ≤ 75.
Preizkušanci so v 9-tedenskem prehodnem obdobju prejemali fleksibilne odmerke (25-100 mg) zdravila Xeplion.
Each Xeplion 25 mg pre-filled syringe contains 39 mg paliperidone palmitate.
Ena 25 mg napolnjena injekcijska brizga zdravila Xeplion vsebuje 39 mg paliperidonijevega palmitata.
headache tardive dyskinesia, syncope, psychomotor hyperactivity, dizziness postural, disturbance in attention, dysarthria, dysgeusia, hypoaesthesia, paraesthesia neuroleptic malignant syndrome, cerebral ischaemia, unresponsive to stimuli, loss of consciousness, depressed level of consciousness, convulsion e, balance disorder, coordination abnormal diabetic coma, head titubation
glavobol tardivna diskinezija, sinkopa, psihomotorična hiperaktivnost, posturalna omotica, motnje pozornosti, disartrija, disgevzija, hipestezija, parestezija nevroleptični maligni sindrom, možganska ishemija, neodzivnost na dražljaje, izguba zavesti, zmanjšana stopnja zavesti, konvulzije e,
• hives (or "nettle rash"), itching, rash, hair loss, eczema, dry skin, skin redness, acne
• urtikarija (koprivnica), srbenje, izpuščaj, izpadanje las, ekcem, suha koža, pordelost kože, akne
Each Xeplion 50 mg pre-filled syringe contains 78 mg paliperidone palmitate.
Ena 50 mg napolnjena injekcijska brizga zdravila Xeplion vsebuje 78 mg paliperidonijevega palmitata.