FrancophonIA/ELRC3.0 huggingface dataset:
English: The suspension should appear uniform and milky white in colour.
Croatian: Suspenzija treba izgledati jednolično i biti mliječno bijele boje.
English: For both studies, the primary outcome was based on relapse.
Croatian: Kod oba ispitivanja, primarni ishod temeljio se na replasu.
English: Information intended for medical or health care professionals
Croatian: Informacije namijenjene liječnicima ili zdravstvenim radnicima
English: Time(days) since Randomization
Croatian: Vrijeme (dani) od randomizacije
English: Estimated Percent of Subjects Without Relapse
Croatian: Procijenjen postotak ispitanika bez relapsa
English: If you stop receiving your injections, your symptoms of schizophrenia may get worse.
Croatian: Ako prestanete primati injekcije, simptomi shizofrenije mogu se pogoršati.
English: DO NOT divide dose into multiple injections.
Croatian: Doza se NE SMIJE podijeliti u višestruke injekcije.
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 neko od navedenih stanja, recite to svojem liječniku, jer će Vam možda htjeti prilagoditi dozu ili Vas neko vrijeme nadzirati.
English: Body mass index (BMI)/body weight
Croatian: Indeks tjelesne težine (BMI)/tjelesna težina
English: The following terms and frequencies are applied: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Croatian: Za učestalost pojavljivanja korištena je sljedeća klasifikacija: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Do not remove the pouch until the syringe and needle are securely attached.
Croatian: Nemojte ukloniti vrećicu sve dok štrcaljka i igla nisu sigurno pričvršćene.
English: The study was terminated on the basis of a pre-planned interim analysis conducted when 283 subjects had been randomised and 42 relapse events had been observed.
Croatian: Ispitivanje je bilo završeno temeljem unaprijed planirane interim analize koja je provedena nakon što je 283 ispitanika randomizirano i nakon što su zabilježena 42 događaja relapsa.
English: If patient weighs: Less than 90 kg pink hub
Croatian: Ako bolesnik ima: Manje od 90 kg ružičasti vrh
English: > 9 months
Croatian: > 9 mjeseci
English: TREVICTA should not be used during pregnancy unless clearly necessary.
Croatian: TREVICTA se ne smije primjenjivati tijekom trudnoće osim ako nije nužno potrebno.
English: Extrapyramidal symptoms (EPS)
Croatian: Extrapiramidni simptomi (EPS)
English: Since this medicine can lower blood pressure, care should be taken when this medicine is used with other medicines that lower blood pressure.
Croatian: Budući da ovaj lijek može sniziti krvni tlak, potreban je oprez kad se primjenjuje zajedno s drugim lijekovima koji snižavaju krvni tlak.
English: There was a significant difference (p < 0.0001) between the two treatment groups in the time to relapse in favour of TREVICTA.
Croatian: Postojala je značajna razlika (p < 0,0001) u vremenu do relapsa između dvije skupine liječenja u korist lijeka TREVICTA.
English: Do not save for future use.
Croatian: Nemojte čuvati za buduću primjenu.
English: The difference (95% CI) between the treatment groups was 1.2% (-2.7%, 5.1%), meeting non-inferiority criterion based on a margin of -10%.
Croatian: Razlika (95% CI) između skupina liječenja bila je 1,2% (-2,7%, 5,1%), čime se postigao kriterij neinferiornosti na temelju granice od -10%.
English: Unused needle should be discarded and not saved for future use.
Croatian: Neiskorištenu iglu treba baciti, a ne spremiti za buduću uporabu.
English: Recommended re-initiation regimen after missing 4 months to 9 months of TREVICTA
Croatian: Preporučeni režim ponovnog započinjanja liječenja nakon propuštanja lijeka TREVICTA od 4 do 9 mjeseci
English: Each injection must be administered only by a health care professional giving the full dose in a single injection.
Croatian: Svaku injekciju smije primijeniti isključivo zdravstveni radnik dajući punu dozu u jednoj injekciji.
English: However, in the event of an incompletely injected dose, the dose remaining in the syringe should not be re-injected and another dose should not be given since it is difficult to estimate the proportion of the dose actually administered.
Croatian: Međutim, u slučaju nepotpuno injicirane doze, preostalu dozu u štrcaljki ne smije se ponovo injicirati te se ne smije dati druga doza lijeka, budući da je teško procijeniti količinu doista primijenjene doze.
English: Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to TREVICTA is known.
Croatian: Stoga bolesnicima treba savjetovati da ne voze i ne upravljaju strojevima dok se ne ustanovi njihova osobna osjetljivost na lijek TREVICTA.
English: You should not stop using this medicine unless told to do so by your doctor.
Croatian: Ne smijete prestati koristiti ovaj lijek osim ako Vam to nije rekao Vaš liječnik.
English: Taking this medicine with carbamazepine (an anti-epileptic and mood stabiliser) may require a change to your dose of this medicine.
Croatian: Uzimanje ovog lijeka s karbamazepinom (antiepileptik i stabilizator raspoloženja) može zahtijevati promjenu doze ovog lijeka.
English: 4 months to 9 months
Croatian: 4 mjeseca do 9 mjeseci
English: Four metabolic pathways have been identified in vivo, none of which accounted for more than 10% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Croatian: In vivo su utvrđena četiri metabolička puta, od kojih niti jedan ne predstavlja više od 10% doze: dealkilacija, hidroksilacija, dehidrogenacija i razgradnja benzisoksazola.
English: Read complete instructions prior to use.
Croatian: Pročitajte cijelu uputu prije uporabe.
English: If the patient remains symptomatic, they should be managed according to clinical practice.
Croatian: Ako bolesnik i dalje ostane simptomatski, potrebno ga je zbrinuti sukladno kliničkoj praksi.
English: Approximately 80% of the administered radioactivity was recovered in urine and 11% in the faeces.
Croatian: Otprilike 80% primijenjene radioaktivne doze pronađeno je u urinu, a 11% u fecesu.
English: If the last dose of TREVICTA was
Croatian: Ako je posljednja doza lijeka TREVICTA bila
English: Do not use TREVICTA - if you are allergic to paliperidone or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati lijek TREVICTA - ako ste alergični na paliperidon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Elderly Your doctor will determine your dose of this medicine if your kidney function is reduced.
Croatian: Starije osobe Liječnik će Vam odrediti dozu ovog lijeka ako imate smanjenu funkciju bubrega.
English: This medicine is administered by your doctor or other health care professional.
Croatian: Ovaj lijek primijenit će Vam liječnik ili drugi zdravstveni radnik.
English: Last TREVICTA dose (Week 0)
Croatian: Posljednja doza lijeka TREVICTA (tjedan 0)
English: The time to relapse of the placebo group (median 395 days) was significantly shorter than for the TREVICTA group (the median could not be estimated due to the low percentage of subjects with relapse [8.8%]).
Croatian: Vrijeme do relapsa u placebo skupini (medijan 395 dana) bilo je značajno kraće od onog u TREVICTA skupini (medijan se nije mogao procijeniti zbog niskog postotka ispitanika s relapsom [8,8%]).
English: Figure 1: Kaplan-Meier plot of time to relapse - Final analysis
Croatian: Slika 1: Kaplan-Meierov dijagram vremena do relapsa - završna analiza
English: The injection should be administered as soon as possible and then resume the 3-monthly injection schedule.
Croatian: Injekciju treba primijeniti što je prije moguće i zatim nastaviti s rasporedom 3-mjesečne primjene injekcije
English: TREVICTA contains a racemic mixture of (+)- and (-)-paliperidone.
Croatian: TREVICTA sadrži racemičnu smjesu (+) i (-) paliperidona.
English: The safety and efficacy of TREVICTA in children and adolescents < 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost primjene lijeka TREVICTA u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Day 8
Croatian: 8. dan
English: No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Croatian: Nema dostupnih podataka za bolesnike s teškim oštećenjem jetre (Child-Pugh stadij C).
English: If you are given more TREVICTA than needed
Croatian: Ako primite više lijeka TREVICTA nego što ste trebali
English: See also Information intended for medical or healthcare professionals for deltoid injection needle selection based on body weight.
Croatian: Također vidjeti Informacije namijenjene liječnicima ili zdravstvenim radnicima za odabir igle za deltoidnu injekciju na temelju tjelesne težine.
English: Dispose properly
Croatian: Prikladno zbrinite
English: The median time to relapse in either group could not be estimated due to low percentage of subjects with relapse.
Croatian: Medijan vremena do relapsa nije se mogao procijeniti u niti jednoj skupini zbog niskog postotka ispitanika s relapsom.
English: The release profile and dosing regimen of TREVICTA results in sustained therapeutic concentrations.
Croatian: Profil oslobađanja i režim doziranja lijeka TREVICTA rezultiraju održanim terapijskim koncentracijama.
English: Date of first authorisation: 05 December 2014 Date of latest renewal:
Croatian: Datum prvog odobrenja: 05. prosinca 2014.
English: However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death (see section 4).
Croatian: Međutim, stariji bolesnici s demencijom koji se liječe s drugim sličnim lijekovima mogu imati povećan rizik od moždanog udara ili smrti (vidjeti dio 4).
English: Patients should be informed to seek urgent medical care in case that priapism has not been resolved within 4 hours.
Croatian: Bolesnike treba uputiti da potraže hitnu liječničku pomoć u slučaju da prijapizam ne prođe unutar 4 sata.
English: Week number after last TREVICTA dose Week 12 to Week 18, inclusive
Croatian: Broj tjedana nakon posljednje doze lijeka TREVICTA 12. do uključivo 18. tjedan
English: Based on the investigators' ratings, induration, redness, and swelling were absent or mild in ≥ 95% of the assessments.
Croatian: Na temelju ocjene ispitivača induracija, crevnilo i oticanje izostali su ili su bili blagi u ≥ 95% procjena.
English: Safety data involving concomitant use of TREVICTA with other antipsychotics is limited.
Croatian: Sigurnosni podaci koji uključuju istodobnu primjenu lijeka TREVICTA s drugim antipsihoticima su ograničeni.
English: • TREVICTA can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
Croatian: • TREVICTA može podići razinu hormona koji se zove „prolaktin”, što se može vidjeti u krvnim pretragama (što može ili ne mora uzrokovati simptome).
English: What TREVICTA contains
Croatian: Što TREVICTA sadrži
English: The data presented in this paragraph are based on a population pharmacokinetic analysis.
Croatian: Podaci prikazani u ovom odjeljku temelje se na analizi populacijske farmakokinetike.
English: After the injection is complete, use your thumb or a flat surface to secure the needle in the safety mechanism.
Croatian: Nakon završetka injiciranja, uz pomoć Vašeg palca ili ravne površine učvrstite iglu u sigurnosni mehanizam.
English: 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.
Croatian: Odmah zatražite medicinsku pomoć ako Vam se pojavi osip, oticanje grla, svrbež ili problemi s disanjem, jer to mogu biti znakovi ozbiljne alergijske reakcije.
English: Inject slowly, deep into the muscle taking care to avoid injection into a blood vessel.
Croatian: Injicirajte polako, duboko u mišić, pazeći da izbjegnete injiciranje u krvnu žilu.
English: Improvements in functioning, as measured by the Personal and Social Performance scale (PSP), which was observed during the open-label stabilisation phase were maintained during the double-blind phase for both treatment groups.
Croatian: Personal and Social Performance scale, PSP), koja su zabilježena tijekom otvorene faze stabilizacije bila su održana i tijekom dvostruko slijepe faze za obje skupine liječenja.
English: Due to the long-acting nature of TREVICTA, the patient's response to an adjusted dose may not be apparent for several months (see section 5.2).
Croatian: Zbog dugodjelujuće prirode lijeka TREVICTA, bolesnikov odgovor na prilagođenu dozu možda neće biti vidljiv nekoliko mjeseci (vidjeti dio 5.2).
English: Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias.
Croatian: Potrebno je odmah započeti s nadzorom kardiovaskularne funkcije koji treba obuhvatiti kontinuirano elektrokardiografsko praćenje kako bi se uočile moguće aritmije.
English: No interaction study between TREVICTA and lithium has been performed, however, a pharmacokinetic interaction is not likely to occur.
Croatian: Nisu provedena ispitivanja interakcija između lijeka TREVICTA i litija; međutim, nije vjerojatna pojava farmakokinetičke interakcije.
English: Based on the final analysis (N = 305), 42 subjects (29.0%) in the placebo group and 14 subjects (8.8%) in the TREVICTA group had experienced a relapse event during the double blind phase.
Croatian: Temeljem završne analize (N = 305), 42 ispitanika (29,0%) u placebo skupini i 14 ispitanika (8,8%) u TREVICTA skupini doživjelo je relaps tijekom dvostruko slijepe faze.
English: 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.
Croatian: Bolesnike s klinički značajnom neutropenijom treba pažljivo pratiti zbog vrućice ili drugih simptoma ili znakova infekcije, te ih hitno liječiti u slučaju pojave takvih simptoma ili znakova.
English: In this period, 305 symptomatically stable subjects were randomised to continue treatment with TREVICTA (n = 160) or placebo (n = 145) until relapse, early withdrawal, or the end of study.
Croatian: U tom razdoblju, 305 simptomatski stabilnih ispitanika bilo je randomizirano da nastave liječenje lijekom TREVICTA (n = 160) ili placebom (n = 145) do relapsa, ranijeg povlačenja lijeka, ili kraja ispitivanja.
English: Do not administer by any other route.
Croatian: Ne primjenjujte niti jednim drugim putem.
English: Use in patients who are in an acutely agitated or severely psychotic state
Croatian: Primjena u bolesnika u stanju akutne agitacije ili teškom psihotičnom stanju
English: The following information is intended for medical or healthcare professionals only and should be read by the medical or healthcare professional in conjunction with the full prescribing information (Summary of Product Characteristics).
Croatian: Sljedeće informacije namijenjene su samo liječnicima ili zdravstvenim radnicima koji ih moraju pročitati zajedno sa potpunim informacijama o propisivanju lijeka (sažetak opisa svojstava lijeka).
English: In the clinical trials of TREVICTA, akathisia, dyskinesia, dystonia, parkinsonism, and tremor were reported in 3.9%, 0.8%, 0.9%, 3.6%, and 1.4% of subjects, respectively.
Croatian: U kliničkim ispitivanjima lijeka TREVICTA, akatizija, diskinezija, distonija, parkinsonizam i tremor bili su prijavljeni u 3,9%, 0,8%, 0,9%, 3,6%, odnosno 1,4% ispitanika.
English: Following the initial TREVICTA dose, TREVICTA should be administered by intramuscular injection once every 3 months (± 2 weeks, see also Missed dose section).
Croatian: Nakon početne doze lijeka TREVICTA, lijek TREVICTA treba primjenjivati putem intramuskularne injekcije jedanput svaka 3 mjeseca (± 2 tjedna, također vidjeti dio Propuštene doze).
English: After injection
Croatian: Nakon injekcije
English: TREVICTA is not recommended to treat elderly patients with dementia due to increased risk of overall mortality and cerebrovascular adverse reactions.
Croatian: TREVICTA se ne preporučuje za liječenje starijih bolesnika s demencijom zbog povećanog rizika od ukupnog mortaliteta i cerebrovaskularnih nuspojava.
English: Remove air bubbles
Croatian: Uklonite mjehuriće zraka
English: Regardless of patient weight: yellow hub
Croatian: Neovisno o tjelesnoj težini bolesnika: žuti vrh
English: Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive at the time of your next scheduled injection.
Croatian: Ovisno o simptomima, liječnik Vam kod sljedeće zakazane injekcije može povisiti ili sniziti količinu lijeka koju primate.
English: If needed, dose adjustment of TREVICTA can be made every 3 months in increments within the range of 175 mg to 525 mg based on individual patient tolerability and/or efficacy.
Croatian: Ako je potrebno, prilagodba doze lijeka TREVICTA može se napraviti svaka 3 mjeseca s povećanjem doze unutar raspona od 175 mg do 525 mg na temelju na individualne podnošljivosti bolesnika i/ili djelotvornosti.
English: The hazard ratio was 3.81 (95% CI: 2.08, 6.99) indicating a 74% decrease in relapse risk with TREVICTA compared to placebo.
Croatian: Omjer hazarda je bio 3,81 (95% CI: 2,08; 6,99) ukazujući na 74%-tno smanjenje rizika relapsa s lijekom TREVICTA u usporedbi s placebom.
English: TREVICTA should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Croatian: TREVICTA se mora koristiti uz oprez s lijekovima koji povećavaju aktivnost središnjeg živčanog sustava (psihostimulansi, primjerice metilfenidat).
English: Care must be taken to avoid inadvertent injection of TREVICTA into a blood vessel.
Croatian: Treba paziti da se izbjegne nehotično injiciranje lijeka TREVICTA u krvnu žilu.
English: The European Medicines Agency has waived the obligation to submit the results of studies with TREVICTA in all subsets of the paediatric population in schizophrenia.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka TREVICTA u svim podskupinama pedijatrijske populacije sa shizofrenijom.
English: The dose could be adjusted (i.e., 50 mg, 75 mg, 100 mg, or 150 mg) at the week 5 and 9 injections and the injection site could be deltoid or gluteal.
Croatian: Doza se mogla prilagoditi (tj. 50 mg, 75 mg, 100 mg, ili 150 mg) u 5. i 9. tjednu injekcija, a mjesto primjene injekcije moglo je biti deltoidni ili glutealni mišić.
English: To avoid a missed dose of TREVICTA patients may be given the injection up to 2 weeks before or after the 3-month time point.
Croatian: Kako bi se izbjeglo propuštanje doze lijeka TREVICTA bolesnicima se injekcija može primijeniti do 2 tjedna prije ili poslije 3-mjesečne vremenske točke.
English: In the case of acute overdose, the possibility of multiple drug involvement should be considered.
Croatian: U slučaju akutnog predoziranja mora se uzeti u obzir mogućnost predoziranja s većim brojem lijekova.
English: In general, recommended dosing of TREVICTA for elderly patients with normal renal function is the same as for younger adult patients with normal renal function.
Croatian: Općenito, preporučene doze lijeka TREVICTA za starije bolesnike s normalnom bubrežnom funkcijom iste su kao i za mlađe odrasle bolesnike s normalnom bubrežnom funkcijom.
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 izoenzimi citokroma P450, uključujući CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4 i CYP3A5.
English: • loss of menstrual periods, leakage of milk from the breasts
Croatian: • izostanak menstruacije, curenje mlijeka iz dojki
English: Other medicines and TREVICTA Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Then, holding the syringe upright, twist and pull the rubber cap to remove.
Croatian: Zatim, držeći štrcaljku uspravno, odvrnite i povucite gumeni čep kako biste ga uklonili.
English: Since this medicine works primarily in the brain, using other medicines that work in the brain can cause an exaggeration of side effects such as sleepiness or other effects on the brain such as other psychiatric medications, opioids, antihistamines and sleep medication.
Croatian: Budući da ovaj lijek prvenstveno djeluje u mozgu, primjena drugih lijekova koji djeluju u mozgu može izazvati prekomjerno izražene nuspojave poput pospanosti ili druge učinke na mozak poput drugih psihijatrijskih lijekova, opioida, antihistaminika i lijekova za spavanje.
English: A population pharmacokinetic analysis based on data with oral paliperidone prolonged release tablets showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Croatian: Analiza populacijske farmakokinetike temeljena na podacima s oralnim paliperidon tabletama s produljenim oslobađanjem pokazala je nešto nižu izloženost paliperidonu u pušača u usporedbi s nepušačima.
English: The patient should be closely monitored and managed as clinically appropriate until the next scheduled 3-monthly injection of TREVICTA.
Croatian: Potrebno je pažljivo pratiti bolesnika i zbrinuti ga kao što je klinički prikladno do sljedeće zakazane 3mjesečne injekcije lijeka TREVICTA.
English: After shaking the syringe for at least 15 seconds, check the appearance of the suspension in the viewing window.
Croatian: Nakon protresanja štrcaljke tijekom najmanje 15 sekundi, provjerite izgled suspenzije u prozorčiću za pregled suspenzije.
English: 9/L) should discontinue TREVICTA and have their WBC followed until recovery.
Croatian: 9/l) trebaju prestati liječenje lijekom TREVICTA, te im je potrebno pratiti leukocite do oporavka.
English: What TREVICTA looks like and contents of the pack TREVICTA is a white to off-white prolonged release suspension for injection in a pre-filled syringe that your doctor or nurse will shake vigorously to resuspend the suspension before it is given as an injection.
Croatian: Kako TREVICTA izgleda i sadržaj pakiranja TREVICTA je bijela do gotovo bijela suspenzija za injekciju s produljenim oslobađanjem u napunjenoj štrcaljki koju će Vaš liječnik ili medicinska sestra snažno protresti kako bi ju resuspendirali prije primjene u obliku injekcije.
English: Paliperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred (see section 4.8).
Croatian: Paliperidon malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog mogućih učinaka na živčani sustav i vid, poput sedacije, somnolencije, sinkope i zamagljenog vida (vidjeti dio 4.8).
English: Following administration of TREVICTA, the (+) and (-) enantiomers of paliperidone interconvert, reaching an AUC (+) to (-) ratio of approximately 1.7-1.8.
Croatian: Nakon primjene lijeka TREVICTA, (+) i (-) enantiomeri paliperidona se međusobno pretvaraju, tako da omjer AUC između (+) i (-) enantiomera iznosi otprilike 1,7-1,8.
English: Concomitant use of TREVICTA with psychostimulants
Croatian: Istodobna primjena lijeka TREVICTA sa psihostimulansima