FrancophonIA/ELRC3.0 huggingface dataset:
English: Physicians should weigh the risks versus the benefits when prescribing TREVICTA 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.
Croatian: Liječnici trebaju procijeniti koliko korisni učinci nadilaze rizike pri propisivanju lijeka TREVICTA bolesnicima s Parkinsonovom bolešću ili demencijom s Lewyjevim tjelešcima budući da obje skupine bolesnika mogu imati povećan rizik razvoja malignog neuroleptičkog sindroma kao i povećanu osjetljivost na antipsihotike.
English: Full instructions for use and handling of TREVICTA are provided in the package leaflet (See Information intended for medical or health care professionals).
Croatian: Potpune upute za uporabu i rukovanje lijekom TREVICTA nalaze se u uputi o lijeku (vidjeti Informacije namijenjene liječnicima ili zdravstvenim radnicima).
English: 12 mg * All doses of once daily paliperidone prolonged release tablets should be individualised to the specific patient, taking into consideration variables such as reasons for switching, response to previous paliperidone treatment, severity of psychotic symptoms, and/or propensity for side effects.
Croatian: 12 mg * Sve doze paliperidona u obliku tableta s produljenim oslobađanjem jedanput dnevno trebaju biti individualno prilagođene pojedinom bolesniku, uzimajući u obzir varijable poput razloga za prijelaz, odgovora na prethodno liječenje paliperidonom, težine psihotičnih simptoma, i/ili sklonosti nuspojavama.
English: Consideration should be given to the long-acting nature of TREVICTA.
Croatian: Treba uzeti u obzir dugodjelujuću prirodu lijeka TREVICTA.
English: What you need to know before you use TREVICTA
Croatian: Što morate znati prije nego počnete primjenjivati lijek TREVICTA
English: If you have a history of seizures, this medicine may increase your chance of experiencing them.
Croatian: Ako ste skloni nastanku epileptičkih napadaja, ovaj lijek može povećati vjerojatnost da ih dobijete.
English: Elimination of paliperidone decreased with decreasing estimated creatinine clearance.
Croatian: Eliminacija paliperidona se smanjila sukladno smanjenju procijenjenog klirensa kreatinina.
English: • diabetes or worsening of diabetes, increased insulin (a hormone that controls blood sugar levels) in your blood
Croatian: • šećerna bolest ili pogoršanje postojeće šećerne bolesti, povišen inzulin (hormon koji kontrolira razinu šećera u krvi) u krvi
English: It must not be administered by any other route.
Croatian: Ne smije se primijeniti nijednim drugim putem.
English: Missed doses If scheduled dose is missed and the time since last injection is
Croatian: Ako je zakazana doza propuštena i vrijeme od zadnje injekcije iznosi
English: akathisia c, sedation/ somnolence, dystonia c,
Croatian: akatizija c, sedacija/somnole ncija, distonija c,
English: 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.
Croatian: U ispitivanju oralnog paliperidona u osoba s umjerenim oštećenjem jetrene funkcije (Child-Pugh stadij B), plazmatske koncentracije slobodnog paliperidona bile su slične kao u zdravih osoba.
English: If you have responded well to treatment with paliperidone palmitate injection given once a month, your doctor may start treatment with TREVICTA.
Croatian: Ako ste imali dobar odgovor na liječenje paliperidonpalmitatom u obliku injekcije primijenjene jednom mjesečno, Vaš liječnik može započeti s primjenom lijeka TREVICTA.
English: There were no potentially prolactin related adverse reactions among males in either group.
Croatian: Nije bilo nuspojava potencijalno vezanih uz prolaktin među muškarcima u niti jednoj skupini.
English: Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in patients treated with medicinal products with alpha 1a-adrenergic antagonist effect, such as TREVICTA (see section 4.8).
Croatian: Intraoperative Floppy Iris Syndrome; IFIS), primijećen je tijekom operacije katarakte u bolesnika liječenih lijekovima koji imaju učinak alfa 1a-adrenergičkih antagonista, poput lijeka TREVICTA (vidjeti dio 4.8).
English: Subject-rated injection site pain based on a visual analogue scale was low and decreased in intensity over time.
Croatian: Bol na mjestu primjene koju su ispitanici ocjenjivali vizualnom analognom skalom, bila je niska i s vremenom se njezin intenzitet smanjivao.
English: Subjects who were considered clinically stable at the end of the 12-week stabilisation phase were then randomised 1:1 to TREVICTA or placebo in a variable duration double-blind phase (the dose of TREVICTA was the same as the last dose received during the stabilisation phase; this dose remained fixed throughout the double-blind phase).
Croatian: Ispitanici za koje se smatralo da su klinički stabilni na kraju 12. tjedna faze stabilizacije bili su randomizirani u omjeru 1:1 u TREVICTA ili placebo skupinu u različitom vremenskom trajanju dvostruko slijepe faze (doza lijeka TREVICTA bila je ista kao posljednja doza primljena tijekom faze stabilizacije; ova doza je ostala nepromijenjena kroz dvostruko slijepu fazu).
English: C-paliperidone, one week following administration of a single oral dose of 1 mg immediate release
Croatian: C-paliperidonom s trenutnim oslobađanjem, tjedan dana nakon primjene jednokratne peroralne doze od 1 mg
English: Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when TREVICTA is administered with other medicinal products that have this potential, e.g., other antipsychotics, tricyclics.
Croatian: Zbog svojeg potencijala da izazove ortostatsku hipotenziju (vidjeti dio 4.4), može se uočiti aditivan učinak kad se lijek TREVICTA primjenjuje zajedno s drugim lijekovima koji imaju takav potencijal, npr. drugim antipsihoticima ili tricikličkim antidepresivima.
English: Subjects received TREVICTA once every 3 months and received placebo-injectable medication for the other months to maintain the blind.
Croatian: Ispitanici su primili lijek TREVICTA jednom svaka 3 mjeseca te su primili injekciju placeba tijekom ostalih mjeseci kako bi se održala zaslijepljenost.
English: Slowly inject the entire contents of the syringe intramuscularly, deep into the selected deltoid or gluteal muscle.
Croatian: Polako injicirajte cijeli sadržaj štrcaljke intramuskularno, duboko u odabrani deltoidni ili glutealni mišić.
English: Patients with severe neutropenia (absolute neutrophil count
Croatian: Bolesnici s teškom neutropenijom (apsolutni broj neutrofila < 1 x 10
English: Paliperidone also blocks alpha 1-adrenergic receptors and slightly less, H1-histaminergic and alpha 2-adrenergic receptors.
Croatian: Paliperidon ujedno blokira i alfa-1 adrenergičke receptore te u nešto manjoj mjeri H1-histaminske i alfa-2 adrenergičke receptore.
English: Needles from the 1-monthly paliperidone palmitate injectable pack or other commercially available needles must not be used when administering TREVICTA (see Information intended for medical or health care professionals).
Croatian: Igle iz pakiranja paliperidonpalmitata u obliku 1-mjesečne injekcije ili druge komercijalno dostupne igle ne smiju se upotrebljavati kada se primjenjuje lijek TREVICTA (vidjeti Informacije namijenjene liječnicima ili zdravstvenim radnicima).
English: Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another.
Croatian: Paliperidon je aktivni metabolit risperidona, stoga je profil nuspojava ovih tvari (uključujući i oralne formulacije i one koje se primjenjuju injekcijom) međusobno povezan.
English: Prepare for injection
Croatian: Pripremite injekciju
English: • swelling of the face, mouth, eyes, or lips, swelling of the body, arms, or legs
Croatian: • oticanje lica, usta, očiju ili usana, oticanje tijela, ruku i nogu
English: 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.
Croatian: Iako u dosadašnjim kliničkim i epidemiološkim ispitivanjima nije ustanovljena jasna poveznica s primjenom antipsihotika, preporučuje se oprez u bolesnika s relevantnom povijesti bolesti.
English: TREVICTA should be administered by a healthcare professional as a single injection.
Croatian: Lijek TREVICTA treba primijeniti zdravstveni radnik kao jednokratnu injekciju.
English: One female (2.4%) in the TREVICTA group experienced an adverse reaction of amenorrhea, while no potentially prolactin related adverse reactions were noted among females in the placebo group.
Croatian: Jedna žena (2,4%) u TREVICTA skupini doživjela je nuspojavu amenoreje, dok nisu zabilježene nuspojave potencijalno vezane uz prolaktin među ženama u placebo skupini.
English: Concomitant use of TREVICTA with risperidone or oral paliperidone
Croatian: Istodobna primjena lijeka TREVICTA s risperidonom ili oralnim paliperidonom
English: In animals treated with paliperidone palmitate an inflammatory reaction was seen at the intramuscular injection site.
Croatian: Kod životinja liječenih paliperidonpalmitatom opažena je upalna reakcija na mjestu primjene intramuskularne injekcije.
English: Since no effect on the systemic clearance was observed, a clinically significant interaction would not be expected between divalproex sodium prolonged release tablets and TREVICTA intramuscular injection.
Croatian: Budući da nije opažen učinak na sustavni klirens, ne očekuju se klinički značajna interakcija između divalproeksnatrij tableta s produljenim oslobađanjem i TREVICTA intramuskularne injekcije.
English: Hold the syringe upright and tap gently to make any air bubbles rise to the top.
Croatian: Držite uspravno štrcaljku i lagano ju udarite kako bi se mjehurići zraka podigli na vrh.
English: Following a single intramuscular dose of TREVICTA, the plasma concentrations of paliperidone gradually rise to reach maximum plasma concentrations at a median Tmax of 30-33 days.
Croatian: Nakon jednokratne doze lijeka TREVICTA primijenjene intramuskularnom injekcijom, koncentracije paliperidona u plazmi postepeno rastu do postizanja maksimalnih plazmatskih koncentracija u medijanu Tmax od 30-33 dana.
English: Then administer TREVICTA (into deltoid a or gluteal muscle)
Croatian: Zatim primijeniti lijek TREVICTA (u deltoidni a ili glutealni mišić)
English: C-paliperidone, 59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised in the liver.
Croatian: C-paliperidona s trenutnim oslobađanjem, 59% doze izlučeno je u urinu u nepromijenjenom obliku, što upućuje na činjenicu da se paliperidon u jetri ne metabolizira u velikoj mjeri.
English: Effect of smoking on the pharmacokinetics of paliperidone was not studied with TREVICTA.
Croatian: Učinak pušenja na farmakokinetiku paliperdona nije ispitivan s lijekom TREVICTA.
English: A Kaplan Meier plot of time to relapse by treatment group is shown in Figure 1.
Croatian: Kaplan-Meierov dijagram vremena do relapsa prema skupini liječenja prikazan je na slici 1.
English: 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.
Croatian: Lijekovi koji imaju svojstva antagonista dopaminskih receptora povezani su s indukcijom tardivne diskinezije koju obilježavaju ritmički nevoljni pokreti, pretežno jezika i/ili lica.
English: These tumours can be related to prolonged dopamine D2-antagonism and hyperprolactinemia.
Croatian: Ovi tumori mogu biti povezani s produljenim antagonizmom dopamina D2 i hiperprolaktinemijom.
English: Overall incidence from all clinical trials was 0.65% in all subjects treated 1-monthly paliperidone palmitate injectable.
Croatian: Ukupna incidencija iz svih kliničkih ispitivanja bila je 0,65% kod svih ispitanika liječenih paliperidonpalmitatom u obliku 1mjesečne injekcije.
English: Therefore, you should not breast-feed when using this medicine.
Croatian: Stoga ne smijete dojiti dok primate ovaj lijek.
English: TREVICTA should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted.
Croatian: TREVICTA se ne smije primijeniti u zbrinjavanju stanja akutne agitacije ili teških psihotičnih stanja kada je potrebna trenutna kontrola simptoma.
English: The efficacy of TREVICTA in the maintenance treatment of schizophrenia in subjects who have been adequately treated for at least four months with 1-monthly paliperidone palmitate injectable and the last two doses of the same dosage strength was evaluated in one long-term randomised withdrawal double-blind, placebo-controlled study and one long-term double-blind, active-controlled, non-inferiority study.
Croatian: Djelotvornost lijeka TREVICTA u terapiji održavanja kod liječenja shizofrenije u ispitanika koji su odgovarajuće liječeni paliperidonpalmitatom u obliku 1-mjesečne injekcije tijekom najmanje četiri mjeseca i s posljednje dvije doze iste jačine, bila je procijenjena u dugotrajnom randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju povlačenja lijeka i dugotrajnom dvostruko slijepom, aktivno kontroliranom ispitivanju neinferiornosti.
English: If you stop using TREVICTA
Croatian: Ako prestanete primjenjivati lijek TREVICTA
English: Conversely, on discontinuation of carbamazepine, the dose of TREVICTA should be re-evaluated and decreased if necessary.
Croatian: Obrnuto, kad se karbamazepin ukida, dozu lijeka TREVICTA trebalo bi ponovno procijeniti i po potrebi sniziti.
English: TREVICTA contains the active substance paliperidone which belongs to the class of antipsychotic medicines and is used as a maintenance treatment for the symptoms of schizophrenia in adult patients.
Croatian: TREVICTA sadrži djelatnu tvar paliperidon koja pripada skupini antipsihotičkih lijekova i namijenjen je za terapiju održavanja kod simptoma shizofrenije u odraslih bolesnika.
English: Significant weight gain has been reported with TREVICTA use.
Croatian: Značajno povećanje težine prijavljeno je pri uzimanju lijeka TREVICTA.
English: TREVICTA should be administered within 5 minutes after shaking.
Croatian: Lijek TREVICTA treba primijeniti unutar 5 minuta nakon protresanja.
English: In case of severe extrapyramidal symptoms, anticholinergic agents should be administered.
Croatian: U slučaju teških ekstrapiramidnih simptoma treba primijeniti antikolinergičke lijekove.
English: In placebo-controlled trials, diabetes mellitus was reported in 0.32% in subjects treated with 1-monthly paliperidone palmitate injectable compared to a rate of 0.39% in placebo group.
Croatian: U placebo-kontroliranim ispitivanjima, dijabetes melitus je bio prijavljen u 0,32% ispitanika liječenih paliperidonpalmitatom u obliku 1-mjesečne injekcije u usporedbi sa stopom od 0,39% u placebo skupini.
English: Hypersensitivity reactions can occur even in patients who have previously tolerated oral risperidone or oral paliperidone (see section 4.8).
Croatian: Reakcije preosjetljivosti mogu se javiti čak i u bolesnika koji su prethodno podnosili oralni risperidon ili oralni paliperidon (vidjeti dio 4.8).
English: Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are metabolised by cytochrome P450 isozymes.
Croatian: Ne očekuje se da bi paliperidon izazivao klinički značajne farmakokinetičke interakcije s lijekovima koji se metaboliziraju putem izoenzima citokroma P450.
English: The most frequently observed adverse drug reactions reported in ≥ 5% of patients in two double-blind controlled clinical trials of TREVICTA were weight increased, upper respiratory tract infection, anxiety, headache, insomnia, and injection site reaction.
Croatian: Najčešće nuspojave zabilježene u ≥ 5% bolesnika u dva dvostruko slijepa, kontrolirana klinička ispitivanja lijeka TREVICTA bile su povećanje tjelesne težine, infekcija gornjih dišnih puteva, anksioznost, glavobolja, insomnija i reakcija na mjestu primjene injekcije.
English: What TREVICTA is and what it is used for What you need to know before you use TREVICTA How to use TREVICTA
Croatian: Što je TREVICTA i za što se koristi Što morate znati prije nego počnete primjenjivati lijek TREVICTA Kako primjenjivati lijek TREVICTA Moguće nuspojave
English: The specified needle for administration of TREVICTA into the deltoid muscle is determined by the patient's weight.
Croatian: Preporučena veličina igle za primjenu lijeka TREVICTA u deltoidni mišić određena je tjelesnom težinom bolesnika.
English: - if you are allergic to another antipsychotic medicine including the substance risperidone.
Croatian: - ako ste alergični na druge antipsihotičke lijekove koji sadrže tvar risperidon.
English: 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.
Croatian: Metaanaliza 17 kontroliranih kliničkih ispitivanja pokazala je da stariji bolesnici s demencijom koji su liječeni drugim atipičnim antipsihoticima, uključujući risperidon, aripiprazol, olanzapin i kvetiapin, imaju povećan rizik od smrti u odnosu na placebo.
English: The primary efficacy endpoint of the study was the percentage of subjects who had not relapsed at the end of the 48-week double-blind phase based on the Kaplan-Meier 48-week estimate (TREVICTA: 91.2%, 1-monthly paliperidone palmitate injectable: 90.0%).
Croatian: Primarna mjera ishoda za djelotvornost u ispitivanju bio je postotak ispitanika koji nisu imali relaps na kraju 48-tjedne dvostruko slijepe faze na temelju Kaplan-Meierove 48-tjedne procjene (TREVICTA: 91,2%, paliperidonpalmitat u obliku 1-mjesečne injekcije: 90,0%).
English: Shake vigorously
Croatian: Snažno protresti
English: As elderly patients may have reduced renal function, see Renal impairment below for dosing recommendations in patients with renal impairment.
Croatian: Budući da stariji bolesnici mogu imati oslabljenu bubrežnu funkciju, vidjeti odjeljak Oštećenje bubrega ispod za preporuke doziranja u bolesnika s oštećenjem bubrega.
English: Initiate TREVICTA at the following dose
Croatian: Započeti liječenje lijekom TREVICTA u sljedećoj dozi
English: Patients treated with TREVICTA 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.
Croatian: Bolesnike koji se liječe lijekom TREVICTA, treba pratiti zbog simptoma hiperglikemije (kao što su polidipsija, poliurija, polifagija i slabost), a bolesnike s dijabetes melitusom treba redovito pratiti zbog pogoršanja kontrole glukoze.
English: Endocrine disorders hyperprolactinaemia inappropriate antidiuretic hormone secretion, glucose urine present
Croatian: Endokrini poremećaji hiperprolaktinem ija neprimjerena sekrecija antidiuretskog hormona, prisutnost glukoze u urinu
English: Pack sizes: Pack contains 1 pre-filled syringe and 2 needles
Croatian: Veličine pakiranja: Pakiranje sadrži 1 napunjenu štrcaljku i 2 igle.
English: 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.
Croatian: Bolesnici koji prime previše paliperidona mogu imati sljedeće simptome: omamljenost ili sedacija, ubrzano kucanje srca, nizak krvni tlak, abnormalni nalaz EKG-a (električno snimanje rada srca) te spore ili abnormalne pokrete lica, tijela, ruku ili nogu.
English: 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).
Croatian: U ispitivanjima na životinjama paliperidonpalmitat injiciran intramuskularno i paliperidon primijenjen peroralno nisu bili teratogeni, ali su opaženi drugi oblici reproduktivne toksičnosti (vidjeti dio 5.3).
English: This interaction has not been studied with TREVICTA.
Croatian: Ova interakcija nije ispitivana s lijekom TREVICTA.
English: First, open needle pouch by peeling the cover back half way.
Croatian: Prvo otvorite vrećicu s iglom otvarajući omot do polovice.
English: The frequency of adverse reactions is qualified as “not known” because they were not observed in paliperidone palmitate clinical trials.
Croatian: Učestalost nuspojava je određena kao „nepoznato” jer nisu bile zabilježene u kliničkim ispitivanjima s paliperidonpalmitatom.
English: Given the primary central nervous system (CNS) effects of paliperidone (see section 4.8), TREVICTA should be used with caution in combination with other centrally acting medicinal products, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Croatian: S obzirom da paliperidon primarno utječe na središnji živčani sustav (SŽS) (vidjeti dio 4.8), lijek TREVICTA treba primjenjivati uz oprez u kombinaciji s drugim lijekovima s centralnim djelovanjem, npr. anksioliticima, većinom antipsihotika, hipnoticima, opijatima i sl., ili s alkoholom.
English: A total of 379 subjects then received a single dose of TREVICTA in either the deltoid or gluteal muscle in the open-label stabilisation phase (dose was a 3.5 multiple of the last dose of 1-monthly paliperidone palmitate).
Croatian: Zatim je ukupno 379 ispitanika primilo jednu dozu lijeka TREVICTA ili u deltoidni ili u glutealni mišić u otvorenoj fazi stabilizacije (doza je bila 3,5 puta veća od posljednje doze paliperidonpalmitata u obliku 1-mjesečne injekcije).
English: On initiation of carbamazepine, the dose of TREVICTA should be re-evaluated and increased if necessary.
Croatian: Kad se uvodi karbamazepin, dozu lijeka TREVICTA trebalo bi ponovno procijeniti i po potrebi povisiti.
English: Appropriate care is advised when prescribing TREVICTA to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medicinal products with anticholinergic activity or being subject to dehydration.
Croatian: Preporučuje se odgovarajuća skrb kad se TREVICTA propisuje bolesnicima koji će biti izloženi uvjetima koji mogu pridonijeti povišenju osnovne tjelesne temperature, npr. intenzivnom vježbanju, ekstremnim vrućinama, istodobnom uzimanju lijekova s antikolinergičkim djelovanjem ili uvjetima dehidracije.
English: TREVICTA is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min).
Croatian: TREVICTA se ne preporučuje u bolesnika s umjerenim ili teškim oštećenjem bubrega (klirens kreatinina < 50 ml/min).
English: You will receive an injection of TREVICTA in the upper arm or buttocks once every 3 months.
Croatian: Injekciju lijeka TREVICTA primit ćete u nadlakticu ili stražnjicu jednom u svaka 3 mjeseca.