FrancophonIA/ELRC3.0 huggingface dataset:
English: This depends on how well the medicine works for you.
Croatian: To ovisi o tome kako će lijek djelovati na Vas.
English: The PANSS is a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganised thoughts, uncontrolled hostility/excitement, and anxiety/depression.
Croatian: PANSS je validirani upitnik s više postavki koji se sastoji od 5 čimbenika za procjenu pozitivnih simptoma, negativnihsimptoma, dezorganiziranih misli, nekontroliranog neprijateljskog ponašanja/uzbuđenja te anksioznosti/depresije.
English: Elderly Your doctor may reduce your dose of medicine if your kidney function is reduced.
Croatian: Starije osobe Liječnik Vam može smanjiti dozu lijeka ako imate smanjenu funkciju bubrega.
English: INVEGA should not be used during pregnancy unless clearly necessary.
Croatian: INVEGA se ne bi trebala primjenjivati u trudnoći osim ako to nije neophodno.
English: Paliperidone also blocks alfa1-adrenergic receptors and blocks, to a lesser extent, H1-histaminergic and alfa2-adrenergic receptors.
Croatian: Paliperidon ujedno blokira alfa1-adrenergičke receptore te u nešto manjoj mjeri H1-histaminske i alfa2-adrenergičke receptore.
English: INVEGA Flexible Dose (3-12 mg)
Croatian: INVEGA fleksibilna doza (3-12 mg)
English: 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.
Croatian: Zbog potencijalnih učinaka produljene hiperprolaktinemije na rast i spolno sazrijevanje u adolescenata, u obzir se mora uzeti redovita klinička procjena endokrinološkog statusa, uključujući mjerenje visine, težine, spolnog sazrijevanja, praćenje menstruacijskog statusa i ostalih potencijalnih učinaka povezanih s prolaktinom.
English: 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.
Croatian: Ako imate bilo koje od ovih stanja, molimo Vas da se obratite svom liječniku, kako bi mogao prilagoditi dozu lijeka ili nadzirati Vaše stanje.
English: 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.
Croatian: U ispitivanjima na ispitanicima s umjerenim oštećenjem jetre (Child-Pugh stadij B) koncentracije slobodnog paliperidona u plazmi bile su slične onima kod zdravih ispitanika.
English: 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).
Croatian: Nadalje, u ukupnoj populaciji INVEGA nije bila učinkovita s obzirom na psihotične simptome kod bolesnika koji su istovremeno primali stabilizatore raspoloženja i antidepresive, ali ova je populacija bila mala (30 ispitanika s terapijskim odgovorom u skupini s paliperidonom i 20 ispitanika s terapijskim odgovorom u placebo skupini).
English: 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.
Croatian: In vitro ispitivanja na mikrosomima ljudske jetre pokazala su kako paliperidon ne inhibira značajno metabolizam lijekova koje metaboliziraju izozimi citokroma P450, uključujući CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1 CYP3A4 i CYP3A5.
English: A change in the time of administration of INVEGA may improve the impact of sedation on the patient.
Croatian: Promjena vremena primjene lijeka INVEGA može pojačati utjecaj sedacije na bolesnika.
English: Dosing recommendations for elderly patients with normal renal function (≥ 80 mL/min) are the same as for adults with normal renal function.
Croatian: Preporuke za doziranje za starije bolesnike s normalnom bubrežnom funkcijom (≥ 80 ml/min) jednake su kao za odrasle s normalnom bubrežnom funkcijom.
English: • dangerously excessive intake of water, low blood sugar, excessive drinking of water, increased cholesterol in your blood
Croatian: • opasno prekomjerni unos vode, nizak šećer u krvi, prekomjerno pijenje vode, povišen kolesterol u krvi
English: Other special populations No dose adjustment for INVEGA is recommended based on gender, race, or smoking status.
Croatian: Druge posebne populacije Nema posebnih preporuka o prilagodbi doze lijeka INVEGA vezano uz spol, rasu ili pušački status.
English: Paliperidone binds strongly to serotonergic 5-HT2and dopaminergic D2-receptors.
Croatian: Paliperidon se snažno veže na serotoninske 5-HT2- i dopaminske D2receptore.
English: It must not be chewed, broken, or crushed.
Croatian: Ne smije se žvakati, lomiti ili usitnjavati.
English: During treatment with INVEGA regular examination for extrapyramidal symptoms and other movement disorders should also be conducted.
Croatian: Tijekom liječenja lijekom INVEGA također se moraju provoditi redoviti pregledi na ekstrapiramidne simptome i druge poremećaje pokreta.
English: 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).
Croatian: Učinak lijeka INVEGA na depresivne simptome nije pokazan u ovim ispitivanjima, ali je bio pokazan u dugotrajnom ispitivanju s dugodjelujućom formulacijom paliperidona u obliku injekcije (opisano niže u ovom poglavlju).
English: If you notice any of these symptoms seek medical advice immediately
Croatian: Ako primjetite bilo koji od ovih simptoma odmah potražite medicinsku pomoć
English: - Blisters: The tablets are supplied in blisters packed in cartons of 14, 28, 30, 49, 56, and 98 tablets.
Croatian: - Blisteri: Tablete se isporučuju u blisterima pakiranima u kutije po 14, 28, 30, 49, 56 i 98 tableta.
English: A population pharmacokinetic analysis showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Croatian: Analiza populacijske farmakokinetike je pokazala nešto nižu izloženost paliperidonu u pušača u usporedbi s nepušačima.
English: Each bottle contains two silica gel pouches which are provided to absorb moisture and keep the tablets dry.
Croatian: Jedna boca sadrži dvije vrećice sa silika gelom, koje su priložene da bi upile vlagu i održale tablete suhima.
English: 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.
Croatian: Ovo sniženje je u znatnoj mjeri uzrokovano 35 %-tnim povećanjem bubrežnog klirensa paliperidona, vjerojatno kao rezultat indukcije bubrežnog P-gp karbamazepinom.
English: The changes in PANSS total scores from baseline to week 8 and week 26 were numerically similar between the INVEGA and aripiprazole treatment groups.
Croatian: Promjene ukupnog PANSS zbroja u odnosu na početne u 8. tjednu i 26. tjednu bile su slične u skupinama liječenima lijekom INVEGA i aripiprazolom.
English: Caution is recommended if paliperidone is used in such patients.
Croatian: Preporučuje se oprez ukoliko se paliperidon primjenjuje u tih bolesnika.
English: Additionally, in study SCA-3001 in the ITT population the effect on psychotic symptoms measured by PANSS was clearly less pronounced and not reaching statistical significance for patients receiving concomitantly mood stabilisers and/or antidepressants.
Croatian: Osim toga, u ispitivanju SCA-3001 u ITT populaciji učinak na psihotične simptome mjeren PANSS skalom bio je manje izražen te nije dosezao statističku značajnost kod bolesnika koji su istovremeno primali stabilizatore raspoloženja i/ili antidepresive.
English: 9/L) should discontinue INVEGA and have their WBC followed until recovery.
Croatian: 9/l) trebaju prestati uzimati INVEGU, te im je potrebno pratiti leukocite pratiti do opravka.
English: The absolute oral bioavailability of paliperidone following INVEGA administration is 28% (90% CI of 23%-33%).
Croatian: Apsolutna bioraspoloživost paliperidona pri peroralnoj primjeni nakon uzimanja lijeka INVEGA iznosi 28% (90% CI od 23-33%).
English: 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).
Croatian: U dugotrajnom 2-godišnjem ispitivanju, kod ispitanika koji su bili izloženi lijeku INVEGA i tijekom dvostruko slijepih i tijekom otvorenih ispitivanja prijavili su umjereno dobivanje na težini (4,9 kg).
English: Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Croatian: U skupini bolesnika liječenih risperidonom, smrtnost je iznosila 4% u usporedbi s 3,1% za placebo.
English: Paliperidone systemic exposure in adolescent subjects (15 years and older) was comparable to that in adults.
Croatian: Sistemska izloženost paliperidonu u ispitanika adolescenata (od 15 godina i starijih) bila je usporediva s onom u odraslih.
English: 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).
Croatian: Uključeni ispitanici su: 1) zadovoljili DSM-IV kriterije za shizoafektivni poremećaj, što je potvrđeno Strukturiranim kliničkim intervjuom za DSM-IV poremećaje, 2) imali skalu pozitivnih i negativnih simptoma (PANSS) ukupnog rezultata od najmanje 60, i 3) imali izražene simptome raspoloženja što je potvrđeno rezultatom od najmanje 16 na Youngovoj ocjenskoj ljestvici za maniju (YMRS) i/ili Hamiltonovoj ocjenskoj ljestvici 21 za depresiju (HAM-D 21).
English: 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.
Croatian: U jednom kratkotrajnom i dva duža ispitivanja tableta paliperidona s produljenim oslobađanjem, provedenom u adolescenata dobi od 12 godina i starijih sa shizofrenijom, ukupni sigurnosni profil je bio sličan zapaženom i kod odraslih.
English: However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see Renal impairment below).
Croatian: Ipak, budući da stariji bolesnici mogu imati oslabljenu bubrežnu funkciju možda će biti potrebna prilagodba doze sukladno statusu njihove bubrežne funkcije (vidjeti odjeljak niže, Oštećenje bubrega).
English: Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring.
Croatian: Drugi antagonisti dopamina koji se daju skotnim životinjama imali su negativne učinke na učenje i razvoj motorike kod potomaka.
English: Do not stop taking this medicine since you will lose the effects of the medicine.
Croatian: Nemojte prestati uzimati ovaj lijek jer će prestati njegovo djelovanje.
English: 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%).
Croatian: Svojstva otpuštanja lijeka INVEGA rezultiraju minimalnim fluktuacijama vršnih koncentracija u usporedbi s onima koje su uočene kod risperidona trenutnog otpuštanja (indeks fluktuacije 38% naspram 125%).
English: Pregnancy There are no adequate data from the use of paliperidone during pregnancy.
Croatian: Nema adekvatnih podataka o primjeni paliperidona za vrijeme trudnoće.
English: How to take INVEGA
Croatian: Kako uzimati INVEGU
English: In the up to 2-year, open-label treatment study of INVEGA in adolescents with schizophrenia, incidence of elevated serum prolactin levels occurred in 48% of females and 60% of males.
Croatian: U otvorenom ispitivanju u trajanju do 2 godine, u kojem su adolescenti sa shizofrenijom liječeni lijekom INVEGA, incidencija povišenih razina prolaktina u serumu pojavila se u 48% žena i 60% muškaraca.
English: Weight gain
Croatian: Povećana težina
English: Following a single dose, INVEGA exhibits a gradual ascending release rate, allowing the plasma concentrations of paliperidone to steadily rise to reach peak plasma concentration (Cmax) approximately 24 hours after dosing.
Croatian: Nakon primjene jedne doze, INVEGA razvija postupnu uzlaznu brzinu otpuštanja, omogućavajući da koncentracije paliperidona u plazmi postupno rastu sve dok ne ostvare vršnu koncentraciju u plazmi (Cmax) otprilike 24 sata nakon uzimanja.
English: • 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.
Croatian: • imate demenciju (senilnost) i osjetite iznenadnu promijenu u mentalnom stanju ili iznenenadnu slabost ili obamrlost lica, ruku ili nogu, naročito jedne strane, ili nerazumljivo pričate, čak i kratko vrijeme.
English: • stomach or intestinal infection
Croatian: • infekcija želuca ili crijeva
English: In one of these trials, efficacy was assessed in 211 subjects who received flexible doses of INVEGA (3-12 mg once daily).
Croatian: U jednom od ovih ispitivanja, djelotvornost je procijenjena kod 211 ispitanika koji su primili promjenjive doze lijeka INVEGA (3-12 mg jednom dnevno).
English: • 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
Croatian: • prekid provođenja između gornjih i donjih dijelova srca, abnormalno električno provođenje u srcu, produljenje srčanog QT intervala, spori srčani ritam, brzi srčani ritam
English: Statistically superior improvements in manic symptoms as measured by YMRS (secondary efficacy scale) were observed in patients from the flexible-dose study and the INVEGA higher dose in the second study.
Croatian: Statistički superiorna poboljšanja maničnih simptoma mjereno po YMRS (ljestvica sekundarne djelotvornosti) primjećena su kod bolesnika u ispitivanju s fleksibilnom dozom i višom dozom INVEGE u drugom ispitivanju.
English: Endocrine disorders hyperprolactinaemia inappropriate antidiuretic hormone secretion c, glucose urine present
Croatian: Endokrini poremećaji hiperprolaktinemija neadekvatna sekrecija antidiuretskog hormona c, prisutnost glukoze u urinu
English: Weight gain Significant weight gain has been reported with INVEGA use.
Croatian: Značajno povećanje težine prijavljeno je pri uzimanju INVEGE.
English: 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).
Croatian: Plazma koncentracije paliperidona povećane su kod bolesnika s oštećenjem bubrega stoga će kod nekih bolesnika biti potrebno prilagoditi dozu (vidjeti dijelove 4.2 i 5.2).
English: The European Medicines Agency has waived the obligation to submit the results of studies with INVEGA in all subsets of the paediatric population in the treatment of schizoaffective disorders.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka INVEGA u svim podskupinama pedijatrijske populacije sa shizoafektivnim poremećajima.
English: Other medicinal products or herbals which are inducers, e.g., rifampicin and St John´s wort (Hypericum perforatum) may have similar effects on paliperidone.
Croatian: Drugi lijekovi ili biljni pripravci koji su induktori, npr., rifampicin i gospina trava (Hypericum Perforatum) mogu imati sličan učinak na paliperidon.
English: 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.
Croatian: Ukoliko se taj učinak pojavi kod ljudi, može prikriti znakove i simptome predoziranja nekim lijekovima ili stanja poput opstrukcije crijeva, Reyevog sindroma i tumora mozga.
English: The active substance is contained within a non-absorbable shell designed to release the active substance at a controlled rate.
Croatian: Djelatna tvar nalazi se unutar ovojnice koja se ne resorbira, a dizajnirana je za kontrolirano oslobađanje djelatne tvari.
English: In clinical trials with some other atypical antipsychotics, increased risks of death and cerebrovascular accidents have been reported (see section 4.4).
Croatian: U kliničkim ispitivanjima s nekim drugim atipičnim antipsihoticima zabilježen je povećani rizik od smrti i cerebrovaskularnih događaja (vidjeti dio 4.4).
English: Dose dependence for EPS was seen with the two higher doses of INVEGA (9 and 12 mg).
Croatian: Ovisnost EPS o dozi opažena je uz dvije više doze lijeka INVEGA (9 mg i 12 mg).
English: It must be swallowed whole with liquid, and must not be chewed, divided, or crushed.
Croatian: Mora ju se progutati cijelu uz tekućinu i ne smije se žvakati, lomiti niti drobiti.
English: This difference is largely explained by differences in lean body mass and creatinine clearance between men and women.
Croatian: Ta se razlika može objasniti razlikama u nemasnoj tjelesnoj masi i klirensu keratinina kod žena i muškaraca.
English: Medicines 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.
Croatian: Lijekovi koji imaju svojstva antagonista dopaminskih receptora povezani su s indukcijom tardivne diskinezije, koja se očituje ritmičkim nevoljnim pokretima, pretežno jezika i/ili lica.
English: The apparent clearance of paliperidone following INVEGA administration is approximately 19% lower in women than men.
Croatian: Prividni klirens paliperidona nakon uzimanja lijeka INVEGA je otprilike 19% niži kod žena nego kod muškaraca.
English: Paliperidone is the active metabolite of risperidone.
Croatian: Paliperidon je aktivni metabolit risperidona.
English: When symptoms of high prolactin occur, they may include: (in men) breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction, (in women) breast discomfort, leakage of milk from the breasts, missed menstrual periods, or other problems with your cycle.
Croatian: Kada se pojave simptomi visokog prolaktina, oni mogu uključiti: (u muškaraca) oticanje dojki, poteškoće s postizanjem ili održavanjem erekcija ili druge spolne disfunkcije, (u žena) nelagodu u dojkama, curenje mlijeka iz dojki, izostanak menstruacije ili druge probleme s ciklusom.
English: 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.
Croatian: U drugom ispitivanju, djelotvornost je procijenjena kod 203 ispitanika koji su dodijeljeni u jednu od dvije skupine prema jačini doze lijeka INVEGA: 6 mg s mogućnošću smanjenja na 3 mg (n = 105) ili 12 mg s mogućnošću smanjenja na 9 mg (n = 98), jednom dnevno.
English: • neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness)
Croatian: • maligni neuroleptički sindrom (zbunjenost, smanjenje ili gubitak svijesti, visoka temperatura i teška ukočenost mišića)
English: In vitro studies indicate that paliperidone is not an inducer of CYP1A2 activity.
Croatian: In vitro ispitivanja pokazuju da paliperidon nije induktor aktivnosti CYP1A2.
English: For all 3 studies, an active control (olanzapine at a dose of 10 mg) was included.
Croatian: U sva 3 ispitivanja kao aktivna kontrola bio je uključen olanzapin u dozi od 10 mg.
English: • a sensation of spinning (vertigo), ringing in the ears, ear pain
Croatian: • osjećaj vrtoglavice (vertigo), zvonjenje u ušima, bol u uhu
English: 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).
Croatian: Podaci iz farmakokinetičkih ispitivanja na starijim ispitanicima (≥ 65 godina života, n = 26) ukazuju na to da je prividni klirens u stanju dinamičke ravnoteže paliperidona nakon uzimanja lijeka INVEGA bio 20% niži nego kod drugih odraslih ispitanika (18-45 godina, n = 28).
English: Secondary by dose analysis demonstrated the efficacy of 3 mg, 6 mg, and 12 mg dose given once daily.
Croatian: Sekundarna analiza po dozi pokazala je djelotvornost za doze od 3 mg, 6 mg i 12 mg primjenjene jedanput na dan.
English: In case of severe extrapyramidal symptoms, anticholinergic agents should be administered.
Croatian: U slučaju jakih ekstrapiramidalnih simptoma, treba primijeniti antikolinergičke lijekove.
English: 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.
Croatian: Slijedeće nuspojave primijećene su uz primjenu drugog lijeka, jako sličnog paliperidonu, a zove se risperidon, tako da se one mogu očekivati i s INVEGOM: poremećaj hranjenja povezan sa spavanjem, ostali problem s krvnim žilama u mozgu i zvuk pucketanja u plućima.
English: Elimination of paliperidone decreased with decreasing renal function.
Croatian: Eliminacija paliperidona smanjuje se ukoliko je smanjena funkcija bubrega.
English: • sleep disorder, confusion, decreased sexual drive, inability to reach orgasm, nervousness, nightmares
Croatian: • poremećaj spavanja, zbunjenost, smanjena spolna želja, nemogućnost postizanja orgazma, nervoza, noćne more.
English: What INVEGA contains
Croatian: Što INVEGA sadrži
English: • irregular heartbeat, abnormal electrical tracing of the heart (electrocardiogram or ECG), a fluttering or pounding feeling in your chest (palpitations)
Croatian: • nepravilni otkucaji srca, abnormalan električni zapis srca (elektrokardiogram ili EKG), treperenje ili osjećaj udaranja u prsima (palpitacije)
English: You should not breastfeed when taking this medicine.
Croatian: Nemojte dojiti dok uzimate ovaj lijek.
English: On initiation of carbamazepine, the dose of INVEGA should be re-evaluated and increased if necessary.
Croatian: Kad se uvodi karbamazepin, dozu lijeka INVEGA trebalo bi se ponovno procijeniti i po potrebi povećati.
English: - This medicine has not been studied in elderly patients with dementia.
Croatian: - ovaj lijek nije ispitan u starijih bolesnika s demencijom.
English: Paliperidone may antagonise the effect of levodopa and other dopamine agonists.
Croatian: Paliperidon može antagonistički djelovati na učinak levodope i drugih dopaminskih agonista.
English: • erectile dysfunction, ejaculation disorder
Croatian: • erektilni poremećaj, poremećaj ejakulacije
English: 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.
Croatian: Zbog kontroliranog oslobađanja, INVEGA se smije davati samo bolesnicima koji mogu progutati cijelu tabletu.
English: The experience from risperidone is considered valid also for paliperidone.
Croatian: Smatra se da iskustvo iz ispitivanja risperidona vrijedi i za paliperidon.
English: INVEGA Higher Dose (9-12 mg)
Croatian: INVEGA viša doza (9-12 mg)