natgillin/translations-raw huggingface dataset:
• serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing
• resna alergijska reakcija z otekanjem, vključno z grlom, ki lahko vodi v oteženo dihanje
Predefined secondary endpoints included the Personal and Social Performance (PSP) scale and the Clinical Global Impression - Severity (CGI-S) scale.
Vnaprej opredeljena sekundarna končna rezultata sta bila: ocena po lestvici osebnega in socialnega delovanja (Personal and Social Performance-PSP) in ocena po lestvici globalnega kliničnega vtisa glede resnosti (Clinical Global Impression for Severity-CGI-S).
Four metabolic pathways have been identified in vivo, none of which accounted for more than 6.5% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
In vivo so sicer ugotovili štiri presnovne poti, vendar se po nobeni od njih ne presnovi več kot 6,5% zaužitega odmerka: dealkilacija, hidroksilacija, dehidrogenacija in benzizoksazolska cepitev.
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 to a lesser extent than traditional neuroleptics.
Čeprav je močan antagonist D2 in menijo, da tako ublaži pozitivne simptome shizofrenije, povzroča manj katalepsije in oslabi motorične funkcije v manjši meri kot tradicionalni nevroleptiki.
A change in the time of administration of INVEGA may improve the impact of sedation on the patient.
Sprememba v času jemanja zdravila INVEGA lahko izboljša učinek sedacije na bolnika.
• leaking milk from the breasts in girls
• izločanje mleka iz prsi pri dekletih
• sensation of spinning (vertigo).
• občutek vrtenja (vertigo)
Patients should be informed to seek urgent medical care in case that priapism has not been resolved within 3-4 hours.
Bolnike je treba poučiti, da poiščejo zravniško pomoč, če priapizem ne izveni v 2-3 urah.
The 1-7 version of the PANSS was used.
Uporabljali so PANSS lestvico (verzije 1-7).
In clinical trials with some other atypical antipsychotics, increased risks of death and cerebrovascular accidents have been reported (see section 4.4).
V kliničnih preskušanjih z nekaterimi drugimi atipičnimi antipsihotiki so poročali o povečanem tveganju za smrt in cerebrovaskularne dogodke (glejte poglavje 4.4).
A population pharmacokinetic analysis showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Analiza populacijske farmakokinetike je pri kadilcih pokazala malo manjšo izpostavljenost paliperidonu v primerjavi z ne-kadilci.
Efficacy was evaluated using the PANSS.
Učinkovitost so ocenili z vprašalnikom PANSS.
This effect was not observed after discontinuation of treatment.
Po prenehanju zdravljenja učinka niso opažali.
• very low body temperature, a decrease in body temperature
• zelo nizka telesna temperatura, zvečana telesna temperatura
No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Ni podatkov o bolnikih s hudo okvaro jeter (razreda C po Child-Pughu).
The apparent clearance of paliperidone following INVEGA administration is approximately 19% lower in women than men.
Navidezni očistek paliperidona po jemanju zdravila INVEGA je pri ženskah za približno 19% manjši kot pri moških.
The population included subjects with schizoaffective bipolar and depressive types.
V populacijo so bili vključeni preiskovanci s shizoafektivno bipolarno in depresivno motnjo.
• decreased oxygen in parts of your body (because of decreased blood flow), flushing
• zmanjšanje kisika v delih telesa (zaradi zmanjšanega pretoka krvi), rdečica
Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Smrtnost pri bolnikih, zdravljenih z risperidonom, je bila 4%, v primerjavi s 3,1% pri placebu.
Paliperidone systemic exposure in adolescent subjects (15 years and older) was comparable to that in adults.
Sistemska izpostavljenost paliperidonu pri mladostnikih (starih 15 let in več) je bila primerljiva izpostavljenosti pri odraslih.
- if you have heart disease or heart disease treatment that makes you prone to low blood pressure.
- Če imate srčno bolezen ali se zdravite z zdravili za srčne bolezni in ste zato nagnjeni k nizkemu krvnemu tlaku.
Fertility There were no relevant effects observed in the non-clinical studies.
Plodnost V nekliničnih študijah niso opazili pomembnih učinkov.
• dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood
• nevarno majhno število določenih tipov belih krvnih celic, ki jih potrebujete za obrambo pred okužbo v krvi
The plasma concentrations of paliperidone are increased in patients with renal impairment and, therefore, dosage adjustment may be required in some patients (see sections 4.2 and 5.2).
Pri bolnikih z okvaro ledvic je plazemska koncentracija paliperidona povečana, zato je lahko pri nekaterih od njih potrebna prilagoditev odmerjanja (glejte poglavji 4.2 in 5.2).
- if you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour.
- Če imate nenormalno visoke koncentracije hormona prolaktina v krvi ali imate tumor, ki je odvisen od prolaktina.
Approximately 80% of the administered radioactivity was recovered in urine and 11% in the faeces.
Približno 80% zaužite količine radioaktivnosti so izmerili v seču in 11% v blatu.
Maximum mean increases of serum prolactin concentrations were generally observed on day 15 of treatment, but remained above baseline levels at study endpoint.
Največje srednje povečanje serumske koncentracije prolaktina so na splošno opazili na 15. dan zdravljenja, vendar so vrednosti ostale nad začetnimi tudi ob koncu študije.
Since this medicine works primarily in the brain, interference from other medicines (or alcohol) that work in the brain could occur due to additive effect on brain function.
To zdravilo deluje predvsem na možgane, zato druga zdravila (ali alkohol), ki tudi delujejo na možgane, lahko povečajo učinek na delovanje možgan.
There were insufficient data to explore differential effects based on race.
Podatkov za raziskave razlik glede na raso ni bilo dovolj.
• INVEGA can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
• Zdravilo INVEGA lahko zviša nivo hormona, ki ga imenujemo "prolaktin" in ga najdemo na krvnih izvidih (ki lahko ali pa ne povzroči simptomov).
Across all adolescent studies, EPS was more common in adolescents than in adults for each INVEGA dose.
V vseh študijah pri mladostnikih so bili EPS pogostejši pri mladostnikih kot pri odraslih za vsak odmerek zdravila INVEGA.
• erectile dysfunction, ejaculation disorder
• erektilna disfunkcija, motnje ejakulacije
Paliperidone also blocks alfa1-adrenergic receptors and blocks, to a lesser extent, H1-histaminergic and alfa2-adrenergic receptors.
Paliperidon zavira tudi adrenergične receptorje alfa-1 in v manjši meri, tudi histaminske receptorje H1 in adrenergične receptorje alfa-2.
• tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body).
• tardivna diskinezija (nenadzorovano trzanje ali sunkoviti gibi, ki jih ne morete nadzorovati, na obrazu, jeziku ali drugih delih telesa).
Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Ob upoštevanju primarnih učinkov paliperidona na CŽS (glejte poglavje 4.8) je treba zdravilo INVEGA uporabljati previdno v kombinaciji z drugimi zdravili, ki delujejo na osrednje živčevje npr.: anksiolitiki, večina antipsihotikov, hipnotiki, opioidi itd. ali alkoholom.
Only few subjects received the 3 mg dose in both studies and efficacy of this dose could not be established.
V obeh študijah je 3-miligramski odmerek prejelo le nekaj preiskovancev, zato učinkovitosti tega odmerka ni bilo mogoče ugotoviti.
In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5.
Študije in vitro na mikrosomih človeških jeter pa so pokazale, da paliperidon bistveno ne zavira presnove zdravil, ki se presnavljajo z izoencimi citokroma P450, na primer s CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4 in CYP3A5.
In one of these trials, efficacy was assessed in 211 subjects who received flexible doses of INVEGA (3-12 mg once daily).
V enem izmed teh preskušanj so ocenili učinkovitost pri 211 preiskovancih, ki so prejemali prilagodljive odmerke zdravila INVEGA (od 3 do 12 mg enkrat na dan).
Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
Zaradi različnih farmakodinamičnih in farmakokinetičnih profilov antipsihotičnih zdravil je zdravniški nadzor pri prehodu bolnika na drug antipsihotik medicinsko upravičen.
Due to the controlled-release design of the dosage form, INVEGA should only be used in patients who are able to swallow the tablet whole.
Zaradi odmerne oblike z nadzorovanim sproščanjem smete zdravilo INVEGA uporabljati le pri bolnikih, ki lahko pogoltnejo celo tableto.
dry mouth, toothache
suha usta, zobobol
* Medium dose group: 3 mg for subjects < 51 kg, 6 mg for subjects ≥ 51 kg ** High dose group: 6 mg for subjects < 51 kg, 12 mg for subjects ≥ 51 kg
*Skupina s srednjim odmerkom: 3 mg za preiskovance < 51 kg, 6 mg za preiskovance ≥ 51 kg **Skupina z velikim odmerkom: 6 mg za preiskovance < 51 kg, 12 mg za preiskovance ≥ 51 kg
Paliperidone was not teratogenic in rat and rabbit.
Paliperidon ni bil teratogen pri podganah in kuncih.
In the other study, efficacy was assessed in 203 subjects who were assigned to one of two dose levels of INVEGA: 6 mg with the option to reduce to 3 mg (n = 105) or 12 mg with the option to reduce to 9 mg (n = 98) once daily.
V drugi študiji so učinkovitost ocenili pri 203 preiskovancih, ki so prejemali eno izmed dveh ravni odmerka zdravila INVEGA: 6 mg z možnostjo zmanjšanja na 3 mg (n = 105) ali 12 mg z možnostjo zmanjšanja na 9 mg (n = 98) enkrat na dan.
Additional side effects in adolescents
Dodatni neželeni učinki pri mladostnikih
• decrease in the type of white blood cells that help to protect you against infection, increase in eosinophils (a type of white blood cell) in your blood
• zmanjšanje števila tistih belih krvnih celic, ki vas pomagajo varovati pred okužbami, povečanje števila eozinofilcev (tip belih krvnih celic) v krvi
If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
- This medicine has not been studied in elderly patients with dementia.
- Tega zdravila niso preučevali pri starejših bolnikih z demenco.
• trouble breathing during sleep (sleep apnea), fast, shallow breathing
• težko dihanje med spanjem (začasno prenehanje dihanja med spanjem), hitro, plitvo dihanje
Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents.
Hipotenzijo in kolaps krvnega obtoka zdravite z ustreznimi ukrepi, na primer z intravenskim dajanjem tekočin in/ali simpatikomimetikov.
Do not alternate between taking this medicine with breakfast one day and without having breakfast the next day.
Zdravila ne smete en dan vzeti z zajtrkom, naslednji dan pa brez zajtrka.
In one short-term and two longer-term studies with paliperidone prolonged-release tablets conducted in adolescents 12 years and older with schizophrenia, the overall safety profile was similar to that seen in adults.
V eni kratkotrajni študiji in dveh dolgotrajnih študijah s tabletami paliperidona s podaljšanim sproščanjem pri mladostnikih s shizofrenijo, starih 12 let in več, je bil celokupni varnostni profil podoben varnostnemu profilu pri odraslih.
- if you have difficulty controlling core body temperature or overheating.
- Če imate težave z vzdrževanjem telesne temperature oz. se hitro pregrejete.
• increased liver transaminases in your blood
• zvišane koncentracija jetrnih transaminaz v krvi
• atrial fibrillation (an abnormal heart rhythm), rapid heartbeat upon standing
• atrijska fibrilacija (nenormalen srčni ritem), pohitren srčni utrip ob vstajanju
In a study 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 pri preiskovancih z zmerno okvaro jeter (razreda B po Child-Pughu) so bile plazemske koncentracije prostega paliperidona podobne tistim pri zdravih preiskovancih.
At 2.5 mg/kg/day in females, an effect on learning and memory was observed.
Pri odmerku 2,5 mg/kg/dan pa so pri samicah podganjih mladičev opažali vpliv na učenje in spomin.
The relevance of these tumour findings in rodents in terms of human risk is unknown.
Pomembnost najdbe tumorjev pri glodalcih za oceno tveganja pri človeku pa ni znana.
Because of the potential effects of prolonged hyperprolactinemia on growth and sexual maturation in adolescents, regular clinical evaluation of endocrinological status should be considered, including measurements of height, weight, sexual maturation, monitoring of menstrual functioning, and other potential prolactin-related effects.
Zaradi možnega vpliva podaljšane hiperprolaktinemije na rast in spolno dozorevanje pri mladostnikih, je potrebno redno klinično preverjanje endokrinološkega statusa, vključno z meritvami višine, telesne mase, spolnega zorenja, spremljanje menstrualne funkcije in možnih drugih učinkov, povezanih s prolaktinom.
The following side effects have been seen with the use of another medicine called risperidone that is very similar to paliperidone, so these can also be expected with INVEGA: sleep-related eating disorder, other types of blood vessel problems in the brain and crackly lung sounds.
Naslednji neželeni učinki so se pojavili pri uporabi drugega zdravila, ki ga imenujemo risperidon in je zelo podobno paliperidonu, zato lahko te neželene učinke pričakujemo tudi pri jemanju zdravila INVEGA: s spanjem povezane motnje hranjenja, druge oblike okvar krvnih žil v možganih in prasketanje v pljučih.
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 tradicionalnih nevroleptikov.
Hypersensitivity to the active substance, risperidone, or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino, risperidon ali kater okoli pomožno snov, navedeno v poglavju 6.1.
In adolescents, weight gain should be assessed against that expected with normal growth.
Pridobivanje telesne mase je treba pri mladostnikih primerjati s telesno maso, pričakovano pri normalni rasti.
For specific posology recommendations in the paediatric population see section 4.2.
Za posebna navodila za odmerjenje pri pediatrični populaciji glejte poglavje 4. 2.
• sleep disorder, confusion, decreased sexual drive, inability to reach orgasm, nervousness, nightmares
• motnje spanja, zmedenost, zmanjšana spolna sla, nezmožnost doseganja orgazma, živčnost, nočne more
An effect of INVEGA on depressive symptoms was not demonstrated in these studies, but has been demonstrated in a long-term study with the long-acting injectable formulation of paliperidone (described further down in this section).
Učinka zdravila INVEGA na depresivne simptome v teh raziskavah niso dokazali, dokazali pa so ga v dolgotrajni raziskavi z injekcijami paliperidona s podaljšanim sproščanjem (opisano v nadaljevanju spodaj).
In the long-term 2-year study, the subjects who were exposed to INVEGA during both the double-blind and open-label studies reported a modest weight gain (4.9 kg).
V dolgotrajni, 2-letni študiji, so pri bolnikih, ki so bili izpostavljeni zdravilu INVEGA med dvojno slepo in odprto fazo študije, poročali o zmernem povečanju telesne mase (4,9 kg).
The release characteristics of INVEGA result in minimal peak-trough fluctuations as compared to those observed with immediate-release risperidone (fluctuation index 38% versus 125%).
Zaradi značilnosti sproščanja zdravila INVEGA pride do minimalnih nihanj od največje do najmanjše koncentracije v primerjavi s koncentracijami, ugotovljenimi pri risperidonu s takojšnjim sproščanjem (indeks nihanja koncentracij 38% v primerjavi s 125%).
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 zvišane telesne temperature ali drugih simptomov in znakov okužbe in jih zdraviti takoj, ko se pojavijo.
This study demonstrated the efficacy of INVEGA of the medium dose group in adolescent subjects with schizophrenia.
Študija je dokazala učinkovitost srednjega odmerka zdravila INVEGA pri mladostnikih s shizofrenijo.
Other medicinal products or herbals which are inducers, e.g., rifampicin and St John´s wort (Hypericum perforatum) may have similar effects on paliperidone.
Ostala zdravila ali zelišča, ki so induktorji, npr. rifampicin in šentjanževka (Hypericum perforatum) imajo lahko podoben učinek na paliperidon.
Efficacy was also evaluated by calculation of treatment response (defined as decrease in PANSS Total Score ≥ 30% and CGI-C Score ≤ 2) as a secondary endpoint.
Učinkovitost so ocenili tudi z izračunom odziva na zdravljenje (opredeljen kot zmanjšanje skupnega rezultata PANSS za ≥ 30 % in rezultata CGI-C za ≤ 2) kot sekundarnih končnih ciljev.
If a patient develops signs or symptoms indicative of NMS, all antipsychotics, including INVEGA, should be discontinued.
Če se pri bolniku pojavijo znaki ali simptomi, ki kažejo na NMS, je treba ukiniti vse antipsihotike, vključno z zdravilom INVEGA.
• 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, slow heart rate, rapid heart rate
• motnje prevajanja med zgornjimi in spodnjimi deli srca, nenormalna električna prevodnost v srcu, podaljšanje QT intervala vašega srca, počasen srčni utrip, pohitren srčni utrip
If you forget to take INVEGA
Če ste pozabili vzeti zdravilo INVEGA
Moreover, in the pooled population, INVEGA was not efficacious in patients concomitantly receiving mood stabiliser and antidepressants in regard to the psychotic symptoms, but this population was small (30 responders in the paliperidone group and 20 responders in the placebo group).
V združeni populaciji zdravilo INVEGA ni imelo učinka na psihotične simptome pri bolnikih, ki so sočasno prejemali tudi stabilizatorje razpoloženja in antidepresive, vendar je bila ta populacija majhna (30 bolnikov z odzivom v skupini, ki je prejemala paliperidon in 20 bolnikov z odzivom v skupini, ki je prejemala placebo).
• ear infection
• okužba ušesa
Data from a pharmacokinetic study in elderly subjects (≥ 65 years of age, n = 26) indicated that the apparent steady-state clearance of paliperidone following INVEGA administration was 20% lower compared to that of adult subjects (18-45 years of age, n = 28).
Podatki iz farmakokinetične študije pri starejših preiskovancih (starost ≥ 65 let, n=26) so pokazali, da je bil navidezni očistek paliperidona v stanju dinamičnega ravnovesja po jemanju zdravila INVEGA za 20% manjši kot pri odraslih preiskovancih (starost od 18 do 45 let, n=28).
This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain medicines 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 določenih zdravil ali stanj, kot so obstrukcija črevesja, Reyev sindrom in možganski tumorji.
• tremor (shaking)
• tremor (tresavica)
Do not take INVEGA - if you are allergic to paliperidone, risperidone, or any of the other ingredients of this medicine
Ne jemljite zdravila INVEGA - če ste alergični na paliperidon, risperidon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Dose dependence for EPS was seen with the two higher doses of INVEGA (9 and 12 mg).
Odvisnost EPS od odmerka so opazili pri dveh večjih odmerkih zdravila INVEGA (9 mg in 12 mg).
• oversensitivity of the eyes to light, eye infection or "pink eye", dry eye
• preobčutljivost na dnevno svetlobo, okužba oči ali "rdeče oko", suhe oči
Dosing was in the morning without regard to meals.
Zdravilo so jemali zjutraj ne glede na obroke.
The administration of INVEGA should be standardised in relation to food intake (see section 5.2).
Uporaba zdravila INVEGA mora biti standardizirana glede na uživanje hrane (glejte poglavje 5.2).
In rat reproduction studies using risperidone, which is extensively converted to paliperidone in rats and humans, a reduction was observed in the birth weight and survival of the offspring.
V študijah reprodukcije pri podganah z uporabo risperidona, ki se obsežno pretvori v paliperidon tako pri podganah kot pri človeku, so opazili zmanjšanje porodne teže in stopnje preživetja mladičev.
• feeling sleepy or less alert
• občutek zaspanosti ali zmanjšana pozornost
Enrolled subjects 1) met DSM-IV criteria for schizoaffective disorder, as confirmed by the Structured Clinical Interview for DSM-IV Disorders, 2) had a Positive and Negative Syndrome Scale (PANSS) total score of at least 60, and 3) had prominent mood symptoms as confirmed by a score of at least 16 on the Young Mania Rating Scale (YMRS) and/or Hamilton Rating Scale 21 for Depression (HAM-D 21).
Sodelujoči preiskovanci so: 1. izpolnjevali merila DSM-IV za shizoafektivno motnjo, potrjeno s strukturiranim kliničnim pogovorom za motnje DSM-IV; 2. imeli skupni rezultat na lestvici pozitivnih in negativnih simptomov (Positive and Negative Syndrome Scale - PANSS) vsaj 60 ter 3. imeli izrazite razpoloženjske simptome, potrjene z rezultatom vsaj 16 na Youngovi lestvici manije (Young Mania Rating Scale - YMRS) in/ali Hamiltonovi lestvici depresije (Hamilton Rating Scale for Depression - HAM-D 21).
Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Dodatna klinična znaka sta lahko še mioglobinurija (rabdomioliza) in akutna ledvična odpoved.
No interaction study between INVEGA and lithium has been performed, however, a pharmacokinetic interaction is unlikely to occur.
Študij interakcij med zdravilom INVEGA in litijem niso izvedli, vendar farmakokinetične interakcije niso verjetne.
• stomach or intestinal infection
• okužba želodca ali črevesja
The study showed a significantly longer time to relapse in patients treated with the long-acting injectable formulation of paliperidone compared to placebo (p < 0.001).
Študija je pokazala pomembno daljši čas do ponovitve simptomov pri bolnikih zdravljenih z injekcijami paliperidona s podaljšanim sproščanjem v primerjavi s placebom (p<0,001).
• increased insulin (a hormone that controls blood sugar levels) in your blood.
• zvišanje koncentracije insulina (hormon, ki uravnava sladkor v krvi) v krvi
• white blood cell count decreased, decrease in platelets (blood cells that help you stop bleeding), anaemia, decrease in red blood cells
• zmanjšanje števila belih krvnih celic, zmanjšanje števila krvnih ploščic (krvne celice, ki pomagajo zaustaviti krvavitev), anemija, zmanjšanje števila rdečih krvnih celic