natgillin/translations-raw huggingface dataset:
- 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.
- 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
akathisia c, sedation/somnolence, dystonia c, dizziness, dyskinesia c, tremor,
akatizija c, sedacija/somnolenca, distonija c, omotičnost, diskinezija c, tremor,
• incontinence (lack of control) of urine, frequent passing of urine, pain when passing urine
• uhajanje urina (nezmožnost nadzora), pogosto uriniranje, bolečine pri uriniranju
• increased liver transaminases in your blood
• povišane koncentracije jetrnih transaminaz v krvi
• restlessness, feeling sleepy, or less alert
• nemir, občutek zaspanosti ali zmanjšana pozornost
Conversely, on discontinuation of carbamazepine, the dose of Xeplion should be re-evaluated and decreased if necessary.
Ob prekinitvi karbamazepina je treba odmerek zdravila Xeplion ponovno oceniti in po potrebi zmanjšati.
Xeplion should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Pri sočasni uporabi zdravila Xeplion z zdravili, ki povečajo aktivnost centralnega živčnega sistema (psihostimulansi, kot je metilfenidat), je potrebna previdnost.
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).
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).
Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are metabolised by cytochrome P-450 isozymes.
Ni pričakovati, da bi paliperidon povzročil klinično pomembne farmakokinetične interakcije z zdravili, ki se presnavljajo preko citokroma P-450.
Discontinuation of antipsychotic medicinal products should be made in accordance with appropriate prescribing information.
Zdravljenje z antipsihotičnim zdravilom je treba prekiniti skladno z navodilom za predpisovanje zadevnega zdravila.
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.
Čeprav v kliničnih in epidemioloških študijah do zdaj niso ugotovili jasne povezave z uporabo antipsihotikov, pri bolnikih z ustrezno anamnezo priporočamo previdnost.
• sensation of spinning (vertigo), ringing in the ears, ear pain
• občutek vrtenja (vrtoglavica), zvonenje v ušesih, bolečina v ušesu
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.
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.
Also, the iris (the coloured part of the eye) may become floppy during surgery and that may lead to eye damage.
Tudi šarenica (obarvani del očesa) lahko med operacijo postane ohlapna in to lahko povzroči poškodbo očesa.
This interaction has not been studied with Xeplion.
Te interakcije z zdravilom Xeplion niso preučevali.
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.
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.
• leakage of milk from the breasts
• iztekanje mleka iz dojk
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.
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.
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).
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).
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.
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.
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.
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.
Dominating central serotonin antagonism may reduce the tendency of paliperidone to cause extrapyramidal side effects.
Dominantni antagonizem serotonina v osrednjem živčevju lahko zmanjša nagnjenost paliperidona k povzročanju ekstrapiramidnih neželenih učinkov.
• cough, stuffy nose
• kašelj, zamašen nos
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.
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.
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.
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.
The carcinogenic potential of intramuscularly injected paliperidone palmitate was assessed in rats.
Kancerogenost intramuskularno injiciranega paliperidonijevega palmitata so ocenili pri podganah.
Agranulocytosis has been reported very rarely (< 1/10,000 patients) during post-marketing surveillance.
O agranulocitozi, so v obdobju po pridobitvi dovoljenja za promet, poročali zelo redko (< 1/10.000 bolnikov).
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.
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.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
• an increase in body temperature
• povišanje telesne temperature
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).
Zaradi majhnega števila podatkov o zdravilu Xeplion pri preiskovancih z blago okvaro ledvic in farmakokinetičnih simulacij je priporočeno zmanjšanje odmerka (glejte poglavje 4.2).
If you notice any of these symptoms seek medical advice immediately.
Če opazite katerega od teh simptomov, takoj poiščite zdravniško pomoč.
In the case of acute overdose, the possibility of multiple drug involvement should be considered.
V primeru akutnega prevelikega odmerjanja je treba upoštevati možnost, da je bolnik hkrati zaužil več zdravil.
• a change in the way you walk
• sprememba v načinu hoje
• sleep disorder, elated mood (mania), decreased sexual drive, nervousness, nightmares
• motnje spanja, stanje vznesenosti (manija), zmanjšana spolna sla, nervoznost, nočne more
This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain medicinal products or of conditions such as intestinal obstruction, Reye's syndrome and brain tumour.
Če se to pojavi pri človeku, lahko prikrije znake in simptome prevelikega odmerjanja nekaterih zdravil ali stanj, kot so ileus, Reyev sindrom in možganski tumor.
Other signs of parkinsonism include a slow shuffling walk, a tremor while at rest, increased saliva and/or drooling, and a loss of expression on the face.
Drugi znaki parkinsonizma vključujejo počasne, negotove korake, tresenje med počivanjem, povečano izločanje sline in/ali slinjenje in brezizraznost obraza.
Your doctor may adjust your dose of this medicine based on your kidney function.
Zdravnik vam bo morda moral prilagoditi odmerek tega zdravila glede na delovanje ledvic.
Other medicines that have this effect include some medicines used to treat depression or to treat infection, and other antipsychotics.
Med druga zdravila s takim učinkom sodijo nekatera zdravila za zdravljenje depresije, nekatera zdravila za zdravljenje okužb in drugi antipsihotiki.
Maintaining symptom control and delaying relapse of schizophrenia The efficacy of Xeplion in maintaining symptomatic control and delaying relapse of schizophrenia was established in a longer-term double-blind, placebo-controlled, flexible-dose study involving 849 non-elderly adult subjects who met DSM-IV criteria for schizophrenia.
Vzdrževanje nadzora simptomov in zakasnitev relapsa shizofrenije Učinkovitost zdravila Xeplion pri vzdrževanju nadzora simptomov in zakasnitvi relapsa shizofrenije so ugotovili v dolgotrajni, dvojno slepi, s placebom nadzorovani študiji s spremenljivim odmerkom, v kateri je sodelovalo 849 odraslih (starostniki niso bili vključeni), ki so izpolnjevali merila za shizofrenijo DSM-IV.
If less than 6 weeks have elapsed since the last injection, then the previously stabilised dose should be administered as soon as possible, followed by injections at monthly intervals.
Če je od zadnjega injiciranja preteklo manj kot 6 tednov, je treba zadnji uporabljeni odmerek injicirati čim prej, nato pa zdravilo injicirati v mesečnih presledkih.
Based on in vitro studies utilising human liver enzymes, paliperidone is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of paliperidone.
Na podlagi študij in vitro, v katerih so uporabili humane jetrne encime, so ugotovili, da paliperidon ni substrat za encim CYP1A2, zato kajenje ne bi smelo vplivati na farmakokinetiko paliperidona.
• blurry vision, eye infection or "pink eye", dry eye
• zamegljen vid, okužba oči ali "rdeče oko", suhe oči
Xeplion should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Zdravilo Xeplion je treba uporabljati previdno pri bolnikih z epileptičnimi napadi v anamnezi ali z drugimi stanji, ki lahko znižajo prag za epileptični napad.
The experience from risperidone cited below is considered valid also for paliperidone.
Spodaj navedene izkušnje z risperidonom veljajo tudi za paliperidon.
Paliperidone is excreted in the breast milk to such an extent that effects on the breast-fed infant are likely if therapeutic doses are administered to breast-feeding women.
Paliperidon se izloča v materino mleko v tolikšni meri, da bi verjetno vplival na dojenčka, če bi doječa mati jemala terapevtske odmerke zdravila.
You will receive the first injection (150 mg) and second injection (100 mg) of this medicine in the upper arm approximately one week apart.
Prvo (150 mg) in drugo (100 mg) injekcijo tega zdravila boste prejeli v zgornji del roke v razmiku približno enega tedna.
Withdrawal of this medicine may be needed.
Morda bo potrebno prekiniti zdravljenje s tem zdravilom.
If Xeplion is discontinued, its prolonged release characteristics must be considered.
Če prekinemo zdravljenje z zdravilom Xeplion, je treba upoštevati njegovo podaljšano sproščanje.
A third Xeplion injection of 75 mg in either the deltoid or gluteal muscles should be administered 5 weeks after the first injection (regardless of the timing of the second injection).
Tretje injiciranje zdravila Xeplion v odmerku 75 mg v deltoidno ali glutealno mišico je treba opraviti 5 tednov po prvem injiciranju (ne glede na čas drugega injiciranja).
The efficacy of Xeplion in the acute treatment of schizophrenia was established in four short-term (one 9-week and three 13-week) double-blind, randomised, placebo-controlled, fixed-dose studies of acutely relapsed adult inpatients who met DSM-IV criteria for schizophrenia.
Učinkovitost zdravila Xeplion pri zdravljenju akutne shizofrenije so ugotavljali v štirih (eni 9-tedenski in treh 13-tedenskih) kratkotrajnih, dvojno slepih, randomiziranih, s placebom nadzorovanih študijah s fiksnim odmerkom pri hospitaliziranih odraslih bolnikih z akutnim relapsom, ki so ustrezali merilom za shizofrenijo DSM-IV.
Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/or face.
Zdravila z antagonističnim delovanjem na dopaminske receptorje, so povezana z razvojem tardivne diskinezije, za katero so značilni ritmični, nehoteni gibi, predvsem jezika in/ali obraza.
Male rats showed a statistically significant increase in mammary gland adenomas and carcinomas at 30 and 60 mg/kg/month which is 1.2 and 2.2 times the exposure level at the maximum recommended human 150 mg dose.
Pri podganjih samcih so ugotovili statistično značilno povečanje pojavnosti adenomov in karcinomov mlečnih žlez, in sicer pri odmerkih 30 in 60 mg/kg/mesec, kar je enako 1,2-oziroma 2,2-kratni izpostavljenosti največjemu priporočenemu odmerku pri človeku (150 mg).
The day 1 and day 8 initiation doses must each be administered in the deltoid muscle in order to attain therapeutic concentrations rapidly (see section 5.2).
Odmerka na prvi in osmi dan je treba injicirati v deltoidno mišico, da hitro dosežemo terapevtske koncentracije (glejte poglavje 5.2).
The recommended monthly maintenance dose is 75 mg; some patients may benefit from lower or higher doses within the recommended range of 25 to 150 mg based on individual patient tolerability and/or efficacy.
Priporočeni mesečni vzdrževalni odmerek je 75 mg; nekaterim bolnikom koristijo manjši ali večji odmerki, ki so v priporočenem razponu odmerkov od 25 do 150 mg. Odmerek je odvisen od prenašanja zdravila in/ali učinkovitosti pri posameznem bolniku.
Patients treated with Xeplion should be monitored for symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus should be monitored regularly for worsening of glucose control.
Bolnike, ki prejemajo zdravilo Xeplion, je treba spremljati glede simptomov hiperglikemije (kot so polidipsija, poliurija in šibkost) ter redno spremljati bolnike s sladkorno boleznijo glede poslabšanja nadzora koncentracije glukoze v krvi.
In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.
Pri bolnikih z obstoječo sladkorno boleznijo je treba redno spremljati koncentracije sladkorja v krvi.
• have dementia and experience a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time.
• imate demenco in opazite nenadne spremembe svojega duševnega stanja, šibkost ali odrevenelost (največkrat ene strani) obraza, rok ali nog ali nerazločnost govora, četudi samo za kratek čas.
Based on pooled data from the three placebo-controlled, 6-week, fixed-dose trials with oral paliperidone prolonged release tablets (3, 6, 9, and 12 mg), orthostatic hypotension was reported by 2.5% of subjects treated with oral paliperidone compared with 0.8% of subjects treated with placebo.
Po zbranih podatkih iz treh s placebom nadzorovanih, šest-tedenskih, preskušanj peroralnih tablet paliperidona s podaljšanim sproščanjem s stalnimi odmerki (3, 6, 9 in 12 mg) je o ortostatski hipotenziji poročalo 2,5% preiskovancev, ki so se zdravili s peroralnim paliperidonom, v primerjavi z 0,8% preiskovancev, ki so prejemali placebo.
• dystonia: This is a condition involving slow or sustained involuntary contraction of muscles.
• distonija: stanje, ki vključuje počasno in neprekinjeno krčenje mišic.
Seek medical attention right away if you experience a rash, swelling of your throat, itching, or problems breathing as these may be signs of a serious allergic reaction.
Če opazite izpuščaj, vam oteče grlo, vas srbi ali imate težave z dihanjem, takoj poiščite zdravniško pomoč, ker so to lahki znaki hude alergijske reakcije.
• increased GGT (a liver enzyme called gamma-glutamyltransferase) in your blood, increased liver enzymes in your blood
• povečana koncentracija GGT (jetrnega encima, ki ga imenujemo gama glutamil transferaza) v krvi, povečana koncentracija jetrnih encimov v krvi
Occasionally abscess formation occurred.
V nekaterih primerih se je pojavil absces.
The disposition of a single oral dose paliperidone 3 mg prolonged release tablet was studied in subjects with varying degrees of renal function.
Izločanje enkratnega odmerka 3 mg paliperidona v obliki tablet s podaljšanim sproščanjem so preučevali pri preizkušancih z različnimi stopnjami delovanja ledvic.
• problems with movement of your eyes, eye rolling, oversensitivity of the eyes to light, increased tears, redness of the eyes
• težave pri premikanju oči, zavijanje z očmi, preobčutljivost na svetlobo, povečano solzenje,
Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Študije tkivnih kultur so pokazale, da prolaktin lahko spodbuja celično rast v tumorjih dojke pri ljudeh.
Xeplion has not been studied in elderly patients with dementia.
Zdravila Xeplion niso preučevali pri starejših bolnikih z demenco.
Repeat-dose toxicity studies of intramuscularly injected paliperidone palmitate (the 1-month formulation) and orally administered paliperidone in rat and dog showed mainly pharmacological effects, such as sedation and prolactin-mediated effects on mammary glands and genitals.
Študije toksičnosti z večkratnimi odmerki intramuskularno injiciranega paliperidonijevega palmitata ( v obliki 1-mesečnih injekcij) in peroralnega paliperidona na podganah in psih so večinoma pokazale farmakološke učinke, kot so sedacija ter učinki prolaktina na mlečne žleze in spolovila.
Given the primary central nervous system (CNS) effects of paliperidone (see section 4.8), Xeplion should be used with caution in combination with other centrally acting medicinal products, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Ker paliperidon primarno deluje na osrednje živčevje (glejte poglavje 4.8), je treba zdravilo Xeplion uporabljati previdno v kombinaciji z drugimi zdravili, ki tudi delujejo na osrednje živčevje, kot so anksiolitiki, večina antipsihotikov, uspavala, opioidi in podobno ali z alkoholom.
In animals treated with paliperidone palmitate an inflammatory reaction was seen at the intramuscular injection site.
Pri živalih, ki jim aplicirali paliperidonijev palmitat, so opazili vnetno reakcijo na mestu intramuskularnega injiciranja.
• tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue,
• tardivna diskinezija (nenadzorovano trzanje ali sunkoviti gibi, ki jih ne morete nadzorovati, na obrazu, jeziku ali drugih delih telesa).
CARDBOARD CARTON
KARTONASTA ŠKATLA
The need for continuing existing extrapyramidal symptoms (EPS) medicine should be re-evaluated periodically.
Potrebo po zdravilih proti ekstrapiramidnim simptomom je treba redno spremljati.
In placebo-controlled trials, diabetes mellitus was reported in 0.32% in Xeplion-treated subjects compared to a rate of 0.39% in placebo group.
V s placebom nadzorovanih preskušanjih so pri bolnikih, zdravljenih z zdravilom Xeplion poročali o sladkorni bolezni pri 0,32% bolnikov v primerjavi s 0,39% bolnikov v skupini, ki je prejemala placebo.
• a decrease in body temperature
• znižanje telesne temperature
The use of the Xeplion initiation regimen allowed patients to stay in this exposure window of 6-12 mg prolonged release oral paliperidone even on trough pre-dose days (day 8 and day 36).
Uporaba uvajalnega režima zdravila Xeplion je omogočila, da so plazemske koncentracije pri bolnikih ostale znotraj razpona izpostavitve 6-12 mg peroralnega paliperidona s podaljšanim sproščanjem, tudi v dnevih pred naslednjim odmerkom (8. in 36. dan).
37.5 mg every 2 weeks
37,5 mg vsaka 2 tedna
To avoid a missed monthly dose, patients may be given the injection up to 7 days before or after the monthly time point.
Da preprečite spuščanje mesečnega odmerka, lahko zdravilo injicirate do 7 dni pred mesečnim časovnim rokom ali 7 dni po njem.