natgillin/translations-raw huggingface dataset:
CARDBOARD CARTON (150 mg PRE-FILLED SYRINGE, COMPONENT OF TREATMENT INITIATION PACK - WITHOUT BLUE BOX)
KARTONASTA ŠKATLA (150 mg NAPOLNJENA INJEKCIJSKA BRIZGA, KOMPLET ZA UVEDBO ZDRAVLJENJA - BREZ MODREGA OKENCA)
• experience a severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an ‘anaphylactic reaction').
• če se pojavi huda alergijska reakcija, za katero so značilni povišana telesna temperatura, otekanje ust, obraza, ustnic ali jezika, zasoplost, srbenje, kožni izpuščaj in včasih padec krvnega tlaka (posledica »anafilaktične reakcije«).
Caution is warranted in patients receiving both, psychostimulants (e.g., methylphenidate) and paliperidone concomitantly, as extrapyramidal symptoms could emerge when adjusting one or both medications.
Pri bolnikih, ki sočasno prejemajo psihostimulanse (metilfenidat) in paliperidon je potrebna previdnost, ker se ob prilagajanju enega ali obeh zdravil lahko pojavijo ekstrapiramidni simptomi.
Co-administration of oral paliperidone prolonged release tablets at steady-state (12 mg once daily) with divalproex sodium prolonged release tablets (500 mg to 2,000 mg once daily) did not affect the steady-state pharmacokinetics of valproate.
Sočasna uporaba peroralnih tablet paliperidona s podaljšanim sproščanjem v stanju dinamičnega ravnovesja (12 mg na dan) in tablet natrijevega valproata/valprojske kisline (divalproeks) s podaljšanim sproščanjem (500 mg do 2.000 mg enkrat na dan) ni vplivala na farmakokinetiko valproata v stanju dinamičnega ravnovesja.
Concomitant use of Xeplion with risperidone or with oral paliperidone
Sočasna uporaba zdravila Xeplion in risperidona ali peroralnega paliperidona
Endocrine disorders hyperprolactinaemia inappropriate antidiuretic hormone secretion, glucose urine present
Bolezni endokrinega sistema hiperprolaktinemija motnje v izločanju antidiuretičnega hormona, prisotnost glukoze v urinu
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotic medicinal products (frequency unknown).
Pri antipsihotikih so poročali o primerih venske trombembolije, vključno s primeri pljučne embolije in globoke venske tromboze (neznana pogostnost).
Co-administration of a single dose of an oral paliperidone prolonged release tablet 12 mg with divalproex sodium prolonged release tablets (two 500 mg tablets once daily) resulted in an increase of approximately 50% in the Cmax and AUC of paliperidone, likely as a result of increased oral absorption.
Sočasna uporaba enkratnega 12 mg odmerka peroralnega paliperidona s podaljšanim sproščanjem in tablet natrijevega divalproeksa s podaljšanim sproščanjem (dve tableti po 500 mg enkrat na dan) je za približno 50% povečala vrednosti Cmax in AUC paliperidona, kar je verjetno posledica povečane absorpcije.
In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Pri določenih bolnikih s shizofrenijo, ki so se v preteklosti odzvali na zdravljenje s peroralnim paliperidonom ali risperidonom, lahko zdravilo Xeplion uporabljamo brez predhodne stabilizacije s peroralnim zdravilom, če so psihotični simptomi blagi do zmerni in je potrebno zdravljenje z dolgodelujočim zdravilom.
De-aerate the syringe by moving the plunger rod carefully forward.
Zrak iz brizge odstranite tako, da bat previdno potiskate navzgor.
These tumours can be related to prolonged dopamine D2 antagonism and hyperprolactinemia.
Ti tumorji so lahko povezani s podaljšanim antagonističnim delovanjem na dopaminskih receptorjih D2 in hiperprolaktinemijo.
Body temperature regulation
Uravnavanje telesne temperature
• dyskinesia: This is a condition involving involuntary muscle movements, and can include repetitive, spastic or writhing movements, or twitching.
• diskinezija: to stanje vključuje nehotene mišične gibe, lahko vključuje ponavljajoče krče ali trzajoče gibe ali trzanje
The third dose should be administered one month after the second initiation dose.
Tretji odmerek (mesečni vzdrževalni odmerek) je treba injicirati en mesec po drugem začetnem odmerku.
Population pharmacokinetics analysis of data from studies with oral paliperidone revealed no evidence of race-related differences in the pharmacokinetics of paliperidone following Xeplion administration.
Analiza farmakokinetike populacije iz študij s peroralnim paliperidonom ne kaže na z raso povezane razlike v farmakokinetiki paliperidona po uporabi zdravila Xeplion.
50 mg every 2 weeks
50 mg vsaka 2 tedna
1 pre-filled syringe of paliperidone 150 mg and 2 needles 1 pre-filled syringe of paliperidone 100 mg and 2 needles
1 napolnjena injekcijska brizga s 150 mg paliperidona in 2 igli 1 napolnjena injekcijska brizga s 100 mg paliperidona in 2 igli
If you have any of these conditions, please talk to your doctor as he/she may want to adjust your dose or monitor you for a while.
Morda bo želel spremeniti odmerek, ki ga jemljete, ali nekaj časa spremljati vaše zdravljenje.
Co-administration of oral paliperidone prolonged release once daily with carbamazepine 200 mg twice daily caused a decrease of approximately 37% in the mean steady-state Cmax and AUC of paliperidone.
Sočasna uporaba peroralnega paliperidona s podaljšanim sproščanjem enkrat na dan in 200 mg karbamazepina dvakrat na dan je zmanjšala povprečje vrednosti Cmax in AUC paliperidona v stanju dinamičnega ravnovesja za približno 37%.
In vitro studies indicate that CYP2D6 and CYP3A4 may be minimally involved in paliperidone metabolism, but there are no indications in vitro nor in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Študije in vitro kažejo, da sta encima CYP2D6 in CYP3A4 minimalno vključena v presnovo paliperidona, vendar ni in vitro in in vivo znakov, da imata ta dva izoencima pomembno vlogo pri presnovi paliperidona.
• pneumonia, infection of the chest (bronchitis), infection of the breathing passages, sinus infection, bladder infection, ear infection, fungal infection of the nails, tonsillitis, infection of the skin
• pljučnica, okužba v prsnem košu (bronhitis), okužba dihalnih poti, okužba obnosnih votlin (sinusov), okužba mehurja, okužba ušes, glivična okužba nohtov, tonzilitis (vnetje mandljev), okužba kože
Treatment initiation pack: Each pack contains 1 pack of Xeplion 150 mg and 1 pack of Xeplion 100 mg.
Pakiranje za uvajanje zdravljenja: Ena škatla vsebuje 1 škatlo s 150 mg in 1 škatlo s 100 mg zdravila Xeplion.
• accumulation of pus caused by infection at injection site, deep skin infection, a cyst at injection site, bruising at injection site.
• kopičenje gnoja zaradi okužbe na mestu injiciranja, globoka okužba kože, cista na mestu injiciranja, modrica na mestu injiciranja
Xeplion should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted.
Zdravila Xeplion ne smemo uporabljati, kadar je potreben takojšen nadzor simptomov pri akutno agitiranih ali zelo psihotičnih bolnikih.
The first initiation dose of Xeplion (150 mg) is to be administered on Day 1 in the DELTOID muscle using the needle for DELTOID injection.
Prvi uvajalni odmerek zdravila Xeplion (150 mg) se injicira na dan 1 v DELTOIDNO mišico in uporabi iglo za injiciranje v DELTOIDNO mišico.
ATC code: N05AX13
Farmakoterapevtska skupina: psiholeptiki, drugi antipsihotiki, oznaka ATC: N05AX13
• neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness), blood vessel problems in the brain, including sudden loss of blood supply to brain (stroke or "mini" stroke), unresponsive to stimuli, loss of consciousness, low level of consciousness, convulsion (fits), balance disorder
• nevroleptični maligni sindrom (zmedenost, zmanjšana stopnja zavesti ali nezavest, visoka telesna temperatura, in huda okorelost mišic), težave s krvnimi žilami v možganih, vključno z nenadno prekinitvijo prekrvavitve možganov (kap ali "mini" kap), neodzivnost na dražljaje,
Overall incidence from all clinical trials was 0.65% in all paliperidone palmitate -treated subjects
V kliničnih preskušanjih je bila skupna pojavnost pri bolnikih, zdravljenih s paliperidonijevim palmitatom 0,65%.
For that reason, it is important to discuss with your doctor any of the following conditions which can potentially worsen during treatment with this medicine:
Nekateri neželeni učinki tega zdravila lahko poslabšajo simptome drugih bolezni, zato je pomembno, da se pogovorite z zdravnikom o morebitnih stanjih, ki se lahko poslabšajo med zdravljenjem s tem zdravilom:
25 mg every 2 weeks
25 mg vsaka 2 tedna
Antipsychotic medicinal products (including risperidone) with alpha-adrenergic blocking effects have been reported to induce priapism.
Poročali so, da antipsihotiki z zaviralnim delovanjem na adrenergične receptorje alfa (vključno z risperidonom) povzročajo priapizem.
Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when Xeplion is administered with other therapeutic agents that have this potential, e.g., other antipsychotics, tricyclics.
Zdravilo Xeplion lahko povzroči ortostatsko hipotenzijo (glejte poglavje 4.4), zato lahko pri sočasni uporabi zdravila Xeplion in drugih zdravil z enakim delovanjem, kot so drugi antipsihotiki, triciklični antidepresivi, mogoče opaziti aditivni učinek.
QT prolongation, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia), sudden unexplained death, cardiac arrest, and Torsade de pointes may occur with antipsychotics.
Pri uporabi antipsihotikov lahko pride do podaljšanja intervala QT, ventrikularnih aritmij (ventrikularna fibrilacija, ventrikularna tahikardija), nenadne nepojasnjene smrti, srčnega zastoja in polimorfne ventrikularne tahikardije (torsade de pointes).
• an interruption in conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval from your heart, rapid heartbeat upon standing, slow heart rate, abnormal electrical tracing of the heart (electrocardiogram or ECG), a fluttering or pounding feeling in your chest (palpitations)
• motnje prevajanja med zgornjimi in spodnjimi deli srca, nenormalna električna prevodnost v srca, podaljšanje intervala QT v zapisu aktivnosti srca, hiter srčni utrip pri vstajanju, počasen srčni utrip, nepravilnosti v spremljanju električne aktivnosti srca (elektrokardiogram ali EKG),
If you are prone to develop convulsions, this medicine may increase your chance of experiencing them.
Če ste že kdaj imeli epileptične napade, lahko to zdravilo poveča tveganje za ponovitev napadov.
Excipients: Polysorbate 20, Polyethylene glycol 4000, Citric acid monohydrate, Disodium hydrogen phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, Sodium hydroxide, Water for injections.
Pomožne snovi: polisorbat 20, polietilenglikol 4000, citronska kislina monohidrat, brezvodni natrijev hidrogenfosfat, natrijev dihidrogenfosfat monohidrat, natrijev hidroksid, voda za injekcije.
The second initiation dose of Xeplion (100 mg) is to also be administered in the DELTOID muscle one week later (Day 8) using the needle for DELTOID injection.
Drugi uvajalni odmerek zdravila Xeplion (100 mg) se prav tako injicira v DELTOIDNO mišico čez en teden (dan 8) in uporabi iglo za injiciranje v DELTOIDNO mišico.
Similarly, the third and subsequent injections after the initiation regimen are recommended to be given monthly.
Prav tako se priporoča, da se tretji odmerek in vsi nadaljnji odmerki ki sledijo uvajanju, injicirajo enkrat na mesec.
Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Xeplion and preventative measures undertaken.
Zato je pred in med zdravljenjem z zdravilom Xeplion treba preveriti vse dejavnike tveganja za VTE in uvesti preventivne ukrepe.
Caution is advised when prescribing Xeplion with medicinal products known to prolong the QT interval, e.g. class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g. amiodarone, sotalol), some antihistaminics, some other antipsychotics and some antimalarials (e.g. mefloquine).
Pri sočasnem predpisovanju zdravila Xeplion z zdravili, za katere je znano, da podaljšajo interval QT, npr. antiaritmiki razreda IA (npr. kinidin, dizopiramid), antiaritmiki razreda III (npr. amiodaron, sotalol), nekateri antihistaminiki, nekateri drugi antipsihotiki in nekateri antimalariki (npr. meflokin), morate biti previdni.
The following symptoms may occur in newborn babies of mothers that have used paliperidone 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 paliperidon, se lahko pojavijo naslednji simptomi: tresenje, okornost ali šibkost mišic, zaspanost, nemir, težave z dihanjem in motnje hranjenja.
For patients with mild renal impairment (creatinine clearance ≥ 50 to < 80 mL/min), recommended initiation of Xeplion is with a dose of 100 mg on treatment day 1 and 75 mg one week later, both administered in the deltoid muscle.
Pri bolnikih z blago okvaro ledvic (očistek kreatinina ≥ 50 do < 80 ml/min) priporočamo uvajanje zdravila Xeplion z odmerkoma 100 mg na prvi dan zdravljenja in 75 mg po enem tednu.
Pack sizes: Pack contains 1 pre-filled syringe and 2 needles.
Velikosti pakiranj: Ena škatla vsebuje 1 napolnjeno injekcijsko brizgo in 2 igli.
Following the second initiation dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle.
Po drugem začetnem odmerku lahko mesečni vzdrževalni odmerek dajemo v deltoidno ali glutealno mišico.
Neuroleptic Malignant Syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated serum creatine phosphokinase levels has been reported to occur with paliperidone.
Poročali so, da se pri uporabi paliperidona lahko pojavi nevroleptični maligni sindrom (NMS), za katerega so značilni hipertermija, mišična rigidnost, avtonomna nestabilnost, spremenjeno stanje zavesti in povišane ravni kreatinin-fosfokinaze v serumu.
Bring the syringe with the attached needle in upright position to de-aerate.
Brizgo z iglo postavite v pokončen položaj, da odstranite zrak.
EPS included a pooled analysis of the following terms: parkinsonism (includes salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, glabellar reflex abnormal, and parkinsonian rest tremor), akathisia (includes akathisia, restlessness, hyperkinesia, and restless leg syndrome), dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia (includes dystonia, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus), and tremor.
EPS so vključevali združeno analizo naslednjih terminov: parkinsonizem (vključuje prekomerno izločanje sline, otrdelost mišic in skeleta, parkinsonizem, slinjenje, rigidnost zobatega kolesa, bradikinezijo, hipokinezijo, obraz maske, mišična napetost, akinezija, okorel vrat, rigidnost mišic, parkinsonska drža in nenormalni grabelarni refleks, parkinsonski tremor v mirovanju); akatizija (vključuje akatizijo, nemir, hiperkinezijo, sindrom nemirnih nog); diskinezija (vključuje diskinezijo, trzanje mišic, horeoatetozo, atetozo, in mioklonus); distonija (vključuje distonijo, hipertonijo, tortikolis, nenadzorovano krčenje mišic, krčenje mišic, blefarospazem, okulogiracijo, paralizo jezika, obrazne krče, laringospazem, miotonijo, opistotonus, orofaringealne krče, plevrototonus, krč jezika in trizmus) in tremor.
What Xeplion contains
Kaj vsebuje zdravilo Xeplion
25-50 mg monthly
25-50 mg na mesec
Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another.
Paliperidon je aktivni presnovek risperidona, zato sta njuna profila neželenih učinkov (peroralne oblike in injekcije) povezana.
When symptoms of high prolactin occur, they may include (in men) breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction;
Če se pojavijo simptomi visokih koncentracij prolaktina, lahko vključujejo: (pri moških) otekanje prsi, težave pri doseganju erekcije ali vzdrževanju erekcije, ali drugo spolno disfunkcijo, (pri ženskah) nelagodje v dojkah, iztekanje mleka iz dojk, izostanek menstruacije ali druge menstruacijske težave.
Undesirable effects noted with risperidone formulations
Neželeni učinki, opaženi pri zdravilih z risperidonom
Each pack contains 1 pre-filled syringe and 2 needles.
Eno pakiranje vsebuje 1 napolnjeno injekcijsko brizgo in 2 igli.
The two initial deltoid intramuscular injections of 150 mg on day 1 and 100 mg on day 8 help attain therapeutic concentrations rapidly.
Uvajalni intramuskularni injiciranji v deltoidno mišico (150 mg prvi dan in 100 mg osmi dan) omogočata hitro doseganje terapevtske koncentracije.
• fever, weakness, fatigue (tiredness)
• vročina, šibkost, utrujenost
• blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg).
• krvni strdki v venah, največkrat v venah nog (simptomi so oteklina, bolečina in rdečina noge).
Since this medicine works primarily in the brain, interference from other medicines that work in the brain can cause an exaggeration of side effects such as sleepiness or other effects on the brain such as other psychiatric medications, opioids, antihistamines and sleep medication.
To zdravilo deluje predvsem na možgane, zato uporaba drugih zdravil (kot so druga psihiatrična zdravila, opioidi, antihistaminiki in zdravila za spanje), ki tudi delujejo na možgane, lahko povzroči prekomerno izraženost neželenih učinkov kot je zaspanost, ali druge učinke na možgane.
Larger decreases in plasma concentrations of paliperidone could occur with higher doses of carbamazepine.
Pri večjih odmerkih karbamazepina se lahko pojavi večje zmanjšanje koncentracij paliperidona v plazmi.
Caution is recommended if paliperidone is used in such patients.
Če paliperidon uporabljamo pri takih bolnikih, je potrebna previdnost.
Cardiac disorders tachycardia atrioventricular block, conduction disorder, electrocardiogram QT prolonged, postural orthostatic tachycardia syndrome, bradycardia, electrocardiogram abnormal, palpitations atrial fibrillation, sinus arrhythmia
Srčne bolezni tahikardija atrioventrikularni blok, motnje prevajanja, podaljšan interval QT na elektrokardiogramu, sindrom posturalne ortostatske tahikardije, bradikardija, nenormalen elektrokardiogram, palpitacije atrijska fibrilacija, sinusna aritmija
Even if you have previously tolerated oral risperidone or oral paliperidone, rarely allergic reactions occur after receiving injections of paliperidone.
Tudi če ste dobro prenašali peroralni risperidon ali peroralni paliperidon, se redko lahko po injiciranju paliperidona pojavijo alergijske reakcije.
Psychiatric disorders insomnia e agitation, depression, anxiety sleep disorder, mania, libido decreased, nervousness, nightmare catatonia, confusional state, somnambulism, blunted affect, anorgasmia sleep-related eating disorder
Psihiatrične motnje nespečnost agitacija, depresija, anksioznost motnje spanja, manija, zmanjšan libido, nervoznost, nočne more katatonija, stanje zmedenosti, somnambulizem, čustvena otopelost, anorgazmija s spanjem povezane motnje hranjenja
• hardening of the skin
• otrdelost kože
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA): http://www.ema.europa.eu/.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING TREATMENT INITIATION PACK OUTER LABEL (WITH BLUE BOX)
PODATKI NA ZUNANJI OVOJNINI KOMPLET ZA UVEDBO ZDRAVLJENJA ZUNANJA OVOJNINA (Z MODRIM OKENCEM)
• Xeplion can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
• Zdravilo Xeplion lahko poviša nivo hormona, ki ga imenujemo "prolaktin" v krvnih preiskavah
Paliperidone may induce orthostatic hypotension in some patients based on its alpha-blocking activity.
Paliperidon lahko pri nekaterih bolnikih povzroči ortostatsko hipotenzijo, ker zavira adrenergične receptorje alfa.
Dizziness, extreme tiredness and vision problems may occur during treatment with this medicine (see section 4).
Vpliv na sposobnost upravljanja vozil in strojev Med zdravljenjem s tem zdravilom se lahko pojavijo omotica, izčrpanost in težave z vidom (glejte poglavje 4).
• dead skin cells at the injection site and an ulcer at the injection site.
• odmrle kožne celice in razjede na mestu injiciranja
Population pharmacokinetics analysis showed no evidence of age related pharmacokinetics differences.
Populacijske farmakokinetične analize niso pokazale nobenih razlik v famakokinetiki zdravila pri uporabi v različnih starostnih skupinah.
In a 13-week study (n = 636) comparing three fixed doses of Xeplion (initial deltoid injection of 150 mg followed by 3 gluteal or deltoid doses of either 25 mg/4 weeks, 100 mg/4 weeks or 150 mg/4 weeks) to placebo, all three doses of Xeplion were superior to placebo in improving the PANSS total score.
V 13-tedenski študiji (n = 636) so primerjali tri fiksne odmerke zdravila Xeplion (uvajalno injiciranje 150 mg v deltoidno mišico, ki so mu sledili trije odmerki, injicirani v glutealno ali deltoidno mišico po 25 mg/4 tedne, 100 mg/4 tedne ali 150 mg/4 tedne) s placebom.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V.
• erectile dysfunction, ejaculation disorder, missed menstrual periods or other problems with your cycle (females), development of breasts in men, sexual dysfunction, breast pain
izostanek menstruacije ali druge motnje menstrualnega cikla (ženske), nastanek dojk pri moških, motnje v spolnosti, bolečina v dojkah
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
Xeplion injection
NAPOLNJENA INJEKCIJSKA BRIZGA
For DELTOID injection, if the patient weighs < 90 kg, use the 1-inch, 23 gauge needle (25.4 mm x 0.64 mm) (needle with blue coloured hub); if the patient weighs ≥ 90 kg, use the 1½-inch, 22 gauge needle (38.1 mm x 0.72 mm) (needle with grey coloured hub).
Če bolnik tehta < 90 kg, za injiciranje v DELTOIDNO mišico uporabite iglo velikosti 25,4 mm x 0,64 mm (1 palec, 23 G) (igla z modrim nastavkom); če bolnik tehta  90 kg, pa uporabite iglo velikosti 38,1 mm x 0,72 mm (1½- palca, 22 G) (igla s sivim nastavkom).
The active substance is paliperidone.
Učinkovina je paliperidon.
Even if you have previously tolerated oral paliperidone or risperidone, rarely allergic reactions occur after receiving injections of Xeplion.
Tudi če ste dobro prenašali peroralni paliperidon ali peroralni risperidon, se lahko po injiciranju zdravila Xeplion redko pojavijo alergijske reakcije.