natgillin/translations-raw huggingface dataset:
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.
To zmanjšanje je, v veliki meri, povzročeno s 35% povečanjem ledvičnega očistka paliperidona, verjetno zaradi indukcije ledvičnega P-gp s karbamazepinom.
• 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
• 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)
Safety data involving concomitant use of Xeplion with other antipsychotics is limited.
Podatki o varnosti sočasne uporabe zdravila Xeplion in drugih antipsihotikov so omejeni.
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”).
To zdravilo lahko povzroči nepravilnosti na elektrokardiogramu (EKG), ki se kaže kot podaljšano potovanje impulza skozi določen del srca (imenovano tudi »podaljšanje intervala QT«).
• yellowing of the skin and the eyes (jaundice)
• porumenelost kože in oči (zlatenica)
• breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
• razgradnja mišičnih vlaken in bolečine v mišicah (rabdomioliza)
Taking this medicine with carbamazepine (an anti-epileptic and mood stabiliser) may require a change to your dose of this medicine.
Sočasno jemanje tega zdravila s karbamazepinom (ki je zdravilo proti epilepsiji in stabilizator razpoloženja) bo morda treba prilagoditi odmerjanje tega zdravila.
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
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
This list is indicative and not exhaustive.
Ta seznam je okviren in ne vsebuje vseh učinkovin.
Patients with severe neutropenia (absolute neutrophil count < 1 x 10
Pri bolnikih s hudo nevtropenijo (absolutno število nevtrofilcev < 1 x 10
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.
Priporočeno odmerjanje zdravila Xeplion pri starejših bolnikih z normalnim delovanjem ledvic je enako kot pri mlajših odraslih bolnikih z normalnim delovanjem ledvic.
This medicine can reduce the effect of medicines against Parkinson's disease and restless legs syndrome (e.g., levodopa).
To zdravilo lahko zmanjša učinke zdravil za zdravljenje Parkinsonove bolezni in sindroma nemirnih nog (npr. levodope).
The pharmacological activity of the (+)- and (-)-paliperidone enantiomers are qualitatively and quantitatively similar.
Farmakološko delovanje (+) in (-) enantiomera paliperidona je kvalitativno in kvantitativno podobno.
Hypersensitivity to the active substance, to risperidone or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino, risperidon ali katero koli pomožno snov, navedeno v poglavju 6.1.
For instructions for use and handling of Xeplion, see package leaflet (information intended for medical or healthcare professionals).
Za navodila za pripravo in ravnanje z zdravilom Xeplion glejte navodilo za uporabo (informacije za zdravstveno osebje).
If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including paliperidone, should be considered.
Če se pojavijo znaki in simptomi tardivne diskinezije, je treba razmisliti o prekinitvi uporabe vseh antipsihotikov, vključno s paliperidonom.
Injury, poisoning and procedural complications fall
Poškodbe in zastrupitve in zapleti pri posegih padci
Refer to ‘Hyperprolactinaemia' below.
Glejte ‘hiperprolaktinemija' spodaj.
There are no adequate data from the use of paliperidone during pregnancy.
O uporabi paliperidona med nosečnostjo ni zadostnih podatkov.
Following administration of paliperidone palmitate the (+) and (-) enantiomers of paliperidone interconvert, reaching an AUC (+) to (-) ratio of approximately 1.6-1.8.
Po injiciranju paliperidonijevega palmitata se (+) in (-) enantiomera medseboj pretvorita tako, da je razmerje AUC med (+) in (-) enantiomerom približno 1,6-1,8.
There is no specific antidote to paliperidone.
Specifičnega antidota za paliperidon ni.
• serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing
• resna alergijska reakcija z otekanjem, ki lahko zajame grlo in povzroči oteženo dihanje
If a patient develops signs or symptoms indicative of NMS, paliperidone should be discontinued.
Če se pri bolniku pojavijo znaki ali simptomi, ki kažejo na NMS, je treba paliperidon ukiniti.
• excessive drinking of water
• prekomerno pitje vode
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).
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).
• low blood sugar
• nizka koncentracija sladkorja v krvi
The safety and efficacy of Xeplion in children and adolescents < 18 years of age have not been established.
Varnost in učinkovitost zdravila Xeplion pri otrocih, mlajših od 18 let, nista ugotovljeni.
Concomitant use of Xeplion with psychostimulants
Sočasna uporaba zdravila Xeplion in psihostimulansov
• trouble breathing during sleep (sleep apnoea)
• težko dihanje med spanjem (začasno prenehanje dihanja med spanjem)
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.
To zdravilo lahko zmanjša potrebo po bruhanju, zato lahko prikrije normalen odziv telesa na zaužitje strupenih snovi ali druga zdravstvena stanja.
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.
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.
• not moving or responding while awake (catatonia)
• negibnost ali neodzivnost v budnem stanju (katatonija)
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.
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.
The suspension for injection is for single use only.
Suspenzija za injiciranje je namenjena samo eni uporabi.
* 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.
* 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.
Other medicines and Xeplion Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
• 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)
• 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)
If you stop receiving your injections, you will lose the effects of the medicine.
Če ste prenehali uporabljati zdravilo Xeplion Če prenehate prejemati injekcije, bodo učinki zdravila izginili.
Xeplion is intended for intramuscular use only.
Zdravilo Xeplion je namenjeno samo intramuskularni uporabi.
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.
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.
This medicine has not been studied in elderly patients with dementia.
Tega zdravila niso preučevali pri starejših bolnikih z demenco.
Paliperidone palmitate and paliperidone were not genotoxic.
Paliperidonijev palmitat in paliperidon nista bila genotoksična.
Elimination of paliperidone decreased with decreasing estimated creatinine clearance.
Izločanje paliperidona se je zmanjšalo skladno z oceno zmanjševanja očistka kreatinina.
Xeplion contains a racemic mixture of (+)- and (-)-paliperidone.
Zdravilo Xeplion vsebuje racemat (+) in (-) paliperidona.
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.
Če ne morete priti na naročeno injiciranje, takoj pokličite zdravnika, da vas čim prej naroči na drug termin.
Paliperidone is not bound to cholinergic receptors.
Paliperidon se ne veže na holinergične receptorje.
The most commonly reported injection site related adverse reaction was pain.
Najpogostejši neželeni učinek, povezan z mestom injiciranja, je bila bolečina.
One week following administration of a single oral dose of 1 mg immediate-release
En teden po uporabi enkratnega peroralnega odmerka 1 mg
• dangerously excessive intake of water
• nevarno prekomerno pitje vode
Very common side effects: may affect more than 1 in 10 people • difficulty falling or staying asleep.
Zelo pogosti: pojavijo se lahko pri vsaj 1 od 10 bolnikov • težave z uspavanjem ali vzdrževanjem spanca
What Xeplion is and what it is used for What you need to know before you use Xeplion How to use Xeplion
Kaj je zdravilo Xeplion in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Xeplion Kako uporabljati zdravilo Xeplion Možni neželeni učinki
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.
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.
• inappropriate secretion of a hormone that controls urine volume
• neustrezno sproščanje hormona, ki uravnava količino izločenega urina
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.
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.
Xeplion is also available in a Treatment initiation pack which contains two pre-filled syringes (150 mg + 100 mg) and 2 additional safety needles.
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.
MARKETING AUTHORISATION HOLDER
Authorisation Holder.
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.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom.
Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Dodatna klinična znaka sta lahko mioglobinurija (rabdomioliza) in akutna ledvična odpoved.
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.
Enotedensko uvajalno odmerjanje (intramuskularni injekciji ob dnevih 1 in 8), kot je opisano v poglavju 4.2, ni potrebno.
Xeplion should then be continued at monthly intervals.
Potem je treba nadaljevati z injiciranjem zdravila Xeplion v mesečnih presledkih.
Xeplion should not be used during pregnancy unless clearly necessary.
Zdravila Xeplion ne smete uporabljati med nosečnostjo, če ni nujno.
Weight should be monitored regularly.
Telesno maso je treba redno spremljati.
• life threatening complications of uncontrolled diabetes
• življenjsko nevarni zapleti pri nenadzorovani sladkorni bolezni
• swelling of the face, mouth, eyes, or lips, swelling of the body, arms or legs
• otekanje obraza, ust, oči ali ustnic, otekline po telesu, rokah ali nogah
Do not store above 30°C.
Zdravilo shranjujte pri temperaturi do 30 °C.
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.
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.
Venous thromboembolism
Venski trombembolizem
• atrial fibrillation (an abnormal heart rhythm), irregular heart beat
• atrijska fibrilacija (motnje srčnega ritma), nepravilen srčni utrip
• inability to pass urine
• nezmožnost odvajanja urina
Body mass index (BMI)/body weight
Indeks telesne mase (ITM)/telesna masa
Antiemetic effect
Antiemetično delovanje
Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face.
Svojega zdravnika takoj obvestite, če se pri vas pojavijo nehoteni ritmični gibi jezika, ust in obraza.
- if you are allergic to another antipsychotic medicine including the substance risperidone.
- če ste alergični na drugo antipsihotično zdravilo, ki vsebuje risperidon.
Potential for Xeplion to affect other medicines
Možnost, da bo zdravilo Xeplion vplivalo na druga zdravila
In vitro studies have shown that paliperidone is a P-gp substrate and a weak inhibitor of P-gp at high concentrations.
Študije in vitro so pokazale, da je paliperidon substrat P-gp in šibek zaviralec P-gp pri velikih koncentracijah.
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)
EU/1/11/672/001(25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg)
Refer to ‘Extrapyramidal symptoms' below.
Glejte ‘ekstrapiramidni simptomi' spodaj.
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.
V teh študijah so fiksne odmerke zdravila Xeplion dajali 1., 8. in 36. dan v devettedenski študiji, v 13-tedenskih pa še 64. dan.
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).
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).
Leucopenia, neutropenia, and agranulocytosis
Levkopenija, nevtropenija in agranulocitoza
• are a man and experience prolonged or painful erection.
• ste moški in se pri vas pojavi boleča ali dolgotrajna erekcija, ki se imenuje priapizem.
Paliperidone binds strongly to serotonergic 5-HT2and dopaminergic D2-receptors.
Paliperidon se močno veže na serotoninske receptorje 5-HT2 in dopaminske receptorje D2.
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.
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.
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.
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.
How to use Xeplion
Kako uporabljati zdravilo Xeplion
See section 4.2 for information on paediatric use.
Za informacije o uporabi pri pediatrični populaciji glejte poglavje 4.2.
Paliperidone is a selective blocking agent of monoamine effects, whose pharmacological properties are different from that of traditional neuroleptics.
Paliperidon je selektiven zaviralec učinkov monoaminov in njegove farmakološke lastnosti se razlikujejo od lastnosti klasičnih nevroleptikov.
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.
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.
The release profile and dosing regimen of Xeplion results in sustained therapeutic concentrations.
Mehanizem sproščanja in režim odmerjanja zdravila Xeplion zagotavljata vzdrževanje terapevtskih koncentracij.
• fast, shallow breathing, pneumonia caused by inhaling food, voice disorder
• hitro, plitvo dihanje, pljučnica, povzročena z vdihnjeno hrano, motnje glasu
Potential for other medicines to affect Xeplion
Možnost, da bodo druga zdravila vplivala na zdravilo Xeplion
• very low body temperature, chills, feeling thirsty
• zelo nizka telesna temperatura, mrazenje, občutek žeje
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.
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.
• coma due to uncontrolled diabetes
• koma zaradi neurejene sladkorne bolezni
Paliperidone also blocks alpha 1-adrenergic receptors and slightly less, H1-histaminergic and alpha 2-adrenergic receptors.
Paliperidon zavira tudi adrenergične receptorje alfa-1 in v manjši meri tudi histaminske receptorje H1 in adrenergične receptorje alfa-2.
• increase in eosinophils (a type of white blood cell) in your blood
• povečano število eozinofilcev (vrste belih krvnih celic) v krvi
On initiation of carbamazepine, the dose of Xeplion should be re-evaluated and increased if necessary.
Ob uvajanju karbamazepina je treba odmerek zdravila Xeplion ponovno oceniti in ga po potrebi povečati.
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).
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).
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
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).
No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Podatkov o uporabi pri bolnikih s hudo okvaro jeter ni (razred C po Child-Pughovi lestvici).
Inject the entire contents intramuscularly slowly, deep into the selected deltoid or gluteal muscle of the patient.
Celotno vsebino intramuskularno injicirajte počasi, globoko v izbrano deltoidno ali glutealno mišico bolnika.
• are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
• če načrtujete operacijo na očesu, okulistu ne pozabite povedati, da prejemate to zdravilo.
Adverse reactions that may suggest increase in prolactin levels (e.g., amenorrhoea, galactorrhoea, menstrual disturbances, gynaecomastia) were reported overall in < 1% of subjects.
O neželenih pojavih, ki bi lahko bili povezani s prolaktinom (amenoreja, galaktoreja, motnje menstruacije, ginekomastija) pa so poročali pri skupaj < 1% preiskovancev.
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.
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.
• glaucoma (increased pressure within the eyeball)
• glavkom (povišan tlak v notranjosti očesa)
Administration should be made into the upper-outer quadrant of the gluteal area.
Zdravilo je treba injicirati v zgornji zunanji kvadrant glutealnega območja.