FrancophonIA/ELRC3.0 huggingface dataset:
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: Following the second initiation dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle.
Croatian: Nakon druge početne doze, mjesečne doze održavanja mogu se primijeniti ili u deltoidni ili u glutealni mišić.
English: Body temperature regulation
Croatian: Regulacija tjelesne temperature
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: In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.
Croatian: U bolesnika s već postojećom šećernom bolesti, glukozu u krvi treba redovito nadzirati.
English: Peel the safety needle blister pouch half way open.
Croatian: Pokrovnu foliju blister pakiranja sigurnosne igle otvorite do pola.
English: Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Croatian: Dodatni klinički znakovi mogu uključivati mioglobinuriju (rabdomiolizu) i akutno zatajenje bubrega.
English: Paliperidone is not bound to cholinergic receptors.
Croatian: Paliperidon se ne veže na kolinergičke receptore.
English: Population pharmacokinetics analysis showed no evidence of age related pharmacokinetics differences.
Croatian: Analiza populacijske farmakokinetike nije ukazala na razlike u farmakokinetici povezane s dobi.
English: • problems with movement of your eyes, eye rolling, oversensitivity of the eyes to light, increased tears, redness of the eyes
Croatian: • problemi s pokretanjem očiju, okretanje očiju, preosjetljivost očiju na svjetlost, pojačano stvaranje suza, crvenilo očiju
English: Endocrine disorders hyperprolactinaemia inappropriate antidiuretic hormone secretion, glucose urine present
Croatian: Endokrini poremećaji hiperprolaktinemija neprimjerena sekrecija antidiuretskog hormona, prisutnost glukoze u urinu
English: In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone's known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms.
Croatian: Općenito, očekivani znakovi i simptomi su oni koji proizlaze iz prekomjerno izraženih poznatih farmakoloških učinaka paliperidona, tj. pospanost i sedacija, tahikardija i hipotenzija, produljenje QT intervala i ekstrapiramidni simptomi.
English: Your doctor may adjust your dose of this medicine based on your kidney function.
Croatian: Liječnik može regulirati dozu ovog lijeka na temelju procjene vaše bubrežne funkcije.
English: • a blockage in the bowels, lack of bowel muscle movement that causes blockage
Croatian: • blokada crijeva, nedostatak pokretanja mišića crijeva što uzrokuje blokadu
English: Administration should be in a single injection.
Croatian: Potrebno je primijeniti samo jednu injekciju.
English: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to End Point- LOCF for Studies R092670-SCH-201, R092670-PSY-3003, R092670-PSY-3004 and R092670-PSY-3007: Primary Efficacy Analysis Set Placebo
Croatian: Ljestvica pozitivnih i negativnih simptoma shizofrenije (PANSS) - ukupan rezultat - promjena od početnih do završnih vrijednosti s prijenosom zadnjeg opažanja (LOCF) za ispitivanja R092670-SCH201, R092670-PSY-3003, R092670-PSY-3004 i R092670-PSY-3007: niz primarnih analiza djelotvornosti
English: The recommended needle size for initial and maintenance administration of Xeplion into the deltoid muscle is determined by the patient's weight.
Croatian: Preporučena veličina igle za primjenu početnih i daljnjih doza lijeka Xeplion u deltoidni mišić određena je tjelesnom težinom bolesnika.
English: • blurry vision, eye infection or "pink eye", dry eye
Croatian: • zamagljen vid, infekcija oka ili „crveno oko”, suho oko
English: Elderly Your doctor may reduce your dose of this medicine if your kidney function is reduced.
Croatian: Starije osobe Liječnik Vam može dati nižu dozu ovog lijeka ako imate smanjenu funkciju bubrega.
English: Anaphylactic reactions in patients who have previously tolerated oral risperidone or oral paliperidone have been rarely reported during post-marketing experience (see sections 4.1 and 4.8).
Croatian: Anafilaktičke reakcije u bolesnika koji su prethodno podnosili oralni risperidon ili oralni paliperidon rijetko su prijavljivane tijekom postmarketinškog iskustva (vidjeti dijelove 4.1 i 4.8).
English: They were either derived from spontaneous post-marketing reports and frequency cannot be determined, or they were derived from risperidone (any formulation) or oral paliperidone clinical trials data and/or post-marketing reports.
Croatian: One su proizašle ili iz spontanih prijava nakon stavljanja lijeka u promet čija se učestalost ne može odrediti ili su proizašle iz podataka kliničkih ispitivanja s risperidonom (bilo kojom formulacijom) ili oralnim paliperidonom i/ili iz prijava nakon stavljanja lijeka u promet.
English: • increase in eosinophils (a type of white blood cell) in your blood
Croatian: • povišenje broja eozinofila (vrsta bijelih krvnih stanica) u krvi
English: Following a single intramuscular dose, the plasma concentrations of paliperidone gradually rise to reach maximum plasma concentrations at a median Tmax of 13 days.
Croatian: Nakon jednokratne intramuskularne doze koncentracije paliperidona u plazmi postupno rastu i dostižu najvišu koncentraciju za medijan Tmax od 13 dana.
English: This medicine is administered by your doctor or other health care professional.
Croatian: Injekciju ovog lijeka će Vam dati liječnik ili drugi zdravstveni radnik.
English: Some patients switching from higher paliperidone oral doses (e.g., 9-12 mg daily) to gluteal injections with Xeplion may have lower plasma exposure during the first 6 months after the switch.
Croatian: Neki bolesnici, koji prelaze s viših peroralnih doza paliperidona (npr., 9-12 mg dnevno) na glutealne injekcije lijeka Xeplion, mogu imati nižu izloženost u plazmi tijekom prvih 6 mjeseci nakon promjene lijeka.
English: In animals treated with paliperidone palmitate an inflammatory reaction was seen at the intramuscular injection site.
Croatian: Kod životinja kojima je primijenjen paliperidonpalmitat opažena je upalna reakcija na mjestu primjene intramuskularne injekcije.
English: • blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg).
Croatian: • krvni ugrušci u venama naročito u nogama (simptomi uključuju oticanje, bol i crvenilo noge).
English: On initiation of carbamazepine, the dose of Xeplion should be re-evaluated and increased if necessary.
Croatian: Kad se uvodi karbamazepin, dozu lijeka Xeplion trebalo bi ponovno procijeniti i po potrebi povisiti.
English: Inject the entire contents intramuscularly slowly, deep into the selected deltoid or gluteal muscle of the patient.
Croatian: Polako ubrizgajte cjelokupan sadržaj intramuskularno, duboko u odabrani deltoidni ili glutealni mišić bolesnika.
English: Xeplion should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted.
Croatian: Xeplion se ne smije koristiti u liječenju stanja akutne agitacije ili teških psihotičnih stanja kad je potrebna trenutna kontrola simptoma.
English: Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when Xeplion is administered with other therapeutic agents that have this potential, e.g., other antipsychotics, tricyclics.
Croatian: Zbog potencijala lijeka Xeplion da izazove ortostatsku hipotenziju (vidjeti dio 4.4), može se uočiti aditivan učinak kad se taj lijek primjenjuje zajedno s drugim lijekovima koji imaju takav potencijal, npr. drugim antipsihoticima ili tricikličkim antidepresivima.
English: This medicine has not been studied in elderly patients with dementia.
Croatian: Ovaj lijek nije ispitivan u starijih bolesnika s demencijom.
English: akathisia c, sedation/somnolence, dystonia c, dizziness, dyskinesia c, tremor,
Croatian: akatizija c, sedacija/somnolencija, distonija c, omaglica, diskinezija c, tremor,
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 se liječe drugim atipičnim antipsihoticima, uključujući risperidon, aripiprazol, olanzapin i kvetiapin imaju povećan rizik od smrti u odnosu na placebo.
English: Given the primary central nervous system (CNS) effects of paliperidone (see section 4.8), Xeplion should be used with caution in combination with other centrally acting medicinal products, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Croatian: S obzirom da paliperidon primarno utječe na središnji živčani sustav (SŽS) (vidjeti dio 4.8), Xeplion 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 third Xeplion injection of 75 mg in either the deltoid or gluteal muscles should be administered 5 weeks after the first injection (regardless of the timing of the second injection).
Croatian: Treću injekciju lijeka Xeplion od 75 mg u deltoidni ili glutealni mišić treba primijeniti 5 tjedana nakon prve injekcije (bez obzira na vrijeme primjene druge injekcije).
English: Xeplion has not been studied in elderly patients with dementia.
Croatian: Xeplion nije ispitivan u starijih bolesnika s demencijom.
English: Significant weight gain has been reported with Xeplion use.
Croatian: Značajno povećanje težine prijavljeno je pri uzimanju lijeka Xeplion.
English: How to store Xeplion
Croatian: Kako čuvati Xeplion
English: Dominating central serotonin antagonism may reduce the tendency of paliperidone to cause extrapyramidal side effects.
Croatian: Dominantni središnji antagonizam serotonina može umanjiti svojstvo paliperidona da uzrokuje ekstrapiramidne nuspojave.
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 istraživanjima na životinjama paliperidonpalmitat injiciran intramuskularno i paliperidon primijenjen peroralno nisu bili teratogeni, ali su opaženi drugi oblici reproduktivne toksičnosti (vidjeti dio 5.3).
English: • fast, shallow breathing, pneumonia caused by inhaling food, voice disorder
Croatian: • brzo, plitko disanje, upala pluća uzrokovana udisanjem hrane, poremećaj glasa
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 Xeplion intramuscular injection.
Croatian: Budući da nije opažen učinak na sustavni klirens, ne očekuju se klinički značajne interakcije između divalproeksnatrij tableta s produljenim oslobađanjem i Xeplion intramuskularne injekcije.
English: Concomitant use of Xeplion with risperidone or with oral paliperidone
Croatian: Istodobna primjena lijeka Xeplion s risperidonom ili oralnim paliperidonom
English: Concomitant administration of oral paliperidone with paroxetine, a potent CYP2D6 inhibitor, showed no clinically significant effect on the pharmacokinetics of paliperidone.
Croatian: Istodobna primjena oralnog oblika paliperidona s paroksetinom, snažnim inhibitorom CYP2D6, nije imala klinički značajan učinak na farmakokinetiku paliperidona.
English: Potential for Xeplion to affect other medicines
Croatian: Mogućnost djelovanja lijeka Xeplion na druge lijekove
English: Paliperidone is not extensively metabolised in the liver.
Croatian: Paliperidon se u jetri ne metabolizira u velikoj mjeri.
English: - if you have Parkinson's disease - if you have ever been diagnosed with a condition whose symptoms include high temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome) - if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia) - if you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines) - if you are diabetic or prone to diabetes - if you have had breast cancer or a tumour in the pituitary gland in your brain - if you have a heart disease or heart disease treatment that makes you prone to low blood pressure - if you have low blood pressure when you stand up or sit up suddenly - if you have epilepsy - if you have kidney problems - if you have liver problems - if you have prolonged and/or painful erection - if you have problems with controlling core body temperature or overheating - if you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour - if you or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.
Croatian: (poznate i pod nazivom maligni neuroleptički sindrom) - ako ste ikada doživjeli abnormalne pokrete jezika ili lica (tardivna diskinezija) - ako znate da ste ikada u prošlosti imali nisku razinu bijelih krvnih stanica (koja je mogla biti uzrokovana drugim lijekovima ili na nju nisu utjecali drugi lijekovi) - ako imate šećernu bolest ili sklonost za šećernu bolest - ako ste imali rak dojke ili tumor hipofize (žlijezde koja se nalazi u mozgu) - ako bolujete od srčane bolesti ili uzimate lijekove za srce zbog kojih ste skloni niskom krvnom tlaku - ako imate nizak krvni tlak kada se iznenada ustanete ili sjednete - ako imate epilepsiju - ako imate poteškoće s bubrezima - ako imate poteškoće s jetrom - ako imate produljenu i/ili bolnu erekciju - ako imate poteškoća s kontrolom unutarnje tjelesne temperature ili pregrijavanjem - ako imate abnormalno visoku razinu hormona prolaktina u krvi ili potencijalno imate o prolaktinu ovisan tumor - ako ste Vi ili netko u Vašoj obitelji imali krvne ugruške, jer su antipsihotici povezani s nastankom krvnih ugrušaka.
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: To sniženje je u znatnoj mjeri uzrokovano 35%-tnim porastom bubrežnog klirensa paliperidona, koji je vjerojatno rezultat indukcije bubrežnog P-glikoproteina karbamazepinom.
English: Agranulocytosis has been reported very rarely (< 1/10,000 patients) during post-marketing surveillance.
Croatian: Tijekom postmarketinškog praćenja, agranulocitoza je bila prijavljena vrlo rijetko (< 1/10 000 bolesnika).
English: The day 1 and day 8 initiation doses must each be administered in the deltoid muscle in order to attain therapeutic concentrations rapidly (see section 5.2).
Croatian: Doze koje se daju 1. i 8. dana moraju se primijeniti u deltoidni mišić kako bi se brzo postigle terapijske koncentracije lijeka (vidjeti dio 5.2).
English: The two initial deltoid intramuscular injections of 150 mg on day 1 and 100 mg on day 8 help attain therapeutic concentrations rapidly.
Croatian: Dvije inicijalne intramuskularne injekcije od 150 mg 1. dana i 100 mg 8. dana omogućavaju brzo postizanje terapijske koncentracije.
English: Close supervision and monitoring should continue until the patient recovers.
Croatian: Bolesnika je potrebno strogo nadzirati i pratiti sve do oporavka.
English: The following symptoms may occur in newborn babies of mothers that have used paliperidone in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Croatian: Sljedeći simptomi mogu se javiti u novorođenčadi čije su majke uzimale paliperidon u posljednjem tromjesečju (posljednja tri mjeseca trudnoće): drhtavica, ukočenost i/ili slabost mišića, pospanost, uznemirenost, problemi s disanjem i poteškoće pri hranjenju.
English: This study included a 33-week open-label acute treatment and stabilisation phase, a randomised, double-blind placebo-controlled phase to observe for relapse, and a 52-week open-label extension period.
Croatian: Ispitivanje je obuhvaćalo 33-tjednu otvorenu fazu akutnog liječenja i stabilizacije, randomiziranu, dvostruko slijepu, placebo-kontroliranu fazu praćenja kako bi se uočio relaps, te otvoreni nastavak ispitivanja u trajanju od 52 tjedna.
English: If less than 6 weeks have elapsed since the last injection, then the previously stabilised dose should be administered as soon as possible, followed by injections at monthly intervals.
Croatian: Ako je od posljednje injekcije prošlo manje od 6 tjedana, tada što je prije moguće treba primijeniti dozu na kojoj je bolesnik prethodno stabiliziran, a zatim nastaviti s injekcijama u mjesečnim intervalima.
English: This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain medicinal products or of conditions such as intestinal obstruction, Reye's syndrome and brain tumour.
Croatian: Ako se javi u ljudi, taj učinak može prikriti znakove i simptome predoziranja nekim lijekovima ili stanja poput opstrukcije crijeva, Reyevog sindroma i tumora mozga.
English: • common cold symptoms, urinary tract infection, feeling like you have the flu
Croatian: • uobičajeni simptomi prehlade, infekcija mokraćnih puteva, osjećaj kao da imate gripu
English: • restlessness, feeling sleepy, or less alert
Croatian: • nemir, osjećaj pospanosti ili smanjena pozornost
English: • parkinsonism: This condition may include slow or impaired movement, sensation of stiffness or tightness of the muscles (making your movements jerky), and sometimes even a sensation of movement "freezing up" and then restarting.
Croatian: • parkinsonizam: ovo stanje može uključiti sporost pri kretanju ili oštećeno kretanje, osjećaj krutosti ili stegnutosti mišića (što uzrokuje trzajne pokrete), a ponekad i „zamrzavanje” pokreta te ponovno pokretanje.
English: Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are metabolised by cytochrome P-450 isozymes.
Croatian: Ne očekuje se da bi paliperidon izazivao klinički značajne farmakokinetičke interakcije s lijekovima koji se metaboliziraju putem izoenzima citokroma P450.
English: Thereafter, the monthly maintenance injections can be administered in either the DELTOID or GLUTEAL muscle using the appropriate needle for the injection site.
Croatian: Nakon toga, mjesečne injekcije za održavanje mogu se primijeniti ili u DELTOIDNI ili u GLUTEALNI mišić, pomoću igle pomoću igle prikladne za mjesto primjene injekcije.
English: The fixed doses of Xeplion in these studies were given on days 1, 8, and 36 in the 9-week study, and additionally on day 64 of the 13-week studies.
Croatian: Fiksne doze lijeka Xeplion u tim su ispitivanjima primijenjene 1., 8. i 36. dana u 9-tjednom ispitivanju te dodatno i 64. dana u 13tjednom ispitivanju.
English: • experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing.
Croatian: • se pojave krvni ugrušci u venama, naročito u nogama (simptomi uključuju oticanje, bol i crvenilo noge), koji mogu putovati kroz krvne žile prema plućima i uzrokovati bol u prsištu i teškoće s disanjem.
English: If the target date for the second Xeplion injection (day 8 ± 4 days) is missed, the recommended reinitiation depends on the length of time which has elapsed since the patient's first injection.
Croatian: Ako se propusti rok za drugu injekciju lijeka Xeplion (8. dan ± 4 dana), preporuke za ponovno započinjanje doziranja ovise o vremenskom razdoblju koje je prošlo od prve injekcije.
English: Based on in vitro studies utilising human liver enzymes, paliperidone is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of paliperidone.
Croatian: Temeljem in vitro ispitivanja u kojima su korišteni enzimi ljudske jetre, paliperidon nije supstrat za CYP1A2; pušenje stoga ne bi trebalo utjecati na farmakokinetiku paliperidona.
English: Tardive dyskinesia/extrapyramidal symptoms
Croatian: Tardivna diskinezija/ekstrapiramidni simptomi
English: Based on a limited number of observations with Xeplion in subjects with mild renal impairment and pharmacokinetic simulations, a reduced dose is recommended (see section 4.2).
Croatian: Na temelju ograničenog broja podataka o lijeku Xeplion u ispitanika s blagim oštećenjem bubrega i farmakokinetičkih simulacija, preporučuje se smanjenje doze (vidjeti dio 4.2).
English: Maintaining symptom control and delaying relapse of schizophrenia The efficacy of Xeplion in maintaining symptomatic control and delaying relapse of schizophrenia was established in a longer-term double-blind, placebo-controlled, flexible-dose study involving 849 non-elderly adult subjects who met DSM-IV criteria for schizophrenia.
Croatian: Održavanje kontrole simptoma i odgađanje relapsa shizofrenije Djelotvornost lijeka Xeplion u održavanju kontrole simptoma i odgađanju ponovnog nastupa shizofrenije utvrđena je u dugotrajnom, dvostruko slijepom, placebo-kontroliranom kliničkom ispitivanju s fleksibilnom dozom lijeka, u koje je bilo uključeno 849 odraslih bolesnika koji su ispunili DSM-IV kriterije za shizofreniju i nisu bili starije dobi.
English: Patients treated with Xeplion should be monitored for symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus should be monitored regularly for worsening of glucose control.
Croatian: Bolesnike koji se liječe lijekom Xeplion, treba pratiti zbog simptoma hiperglikemije (kao što su polidipsija, poliurija, polifagija i slabost), a bolesnike s dijabetes melitusom treba redovito pratiti zbog mogućeg pogoršanja kontrole glukoze.
English: In general, overall initiation plasma levels with Xeplion were within the exposure range observed with 6-12 mg prolonged release oral paliperidone.
Croatian: Općenito, ukupne razine lijeka Xeplion u plazmi u uvodnom razdoblju bile su unutar granica izloženosti opaženog pri dozama od 6-12 mg oralnog oblika paliperidona s produljenim oslobađanjem.
English: In rat reproduction studies with oral risperidone, which is extensively converted to paliperidone in rats and humans, adverse effects were seen on the birth weight and survival of the offspring.
Croatian: U ispitivanjima reprodukcije na štakorima s peroralno primijenjenim risperidonom koji se u velikoj mjeri pretvara u paliperidon i u štakora i ljudi, uočeni su štetni učinci na porođajnu težinu i preživljavanje mladunčadi.
English: Effect of smoking on the pharmacokinetics of paliperidone was not studied with Xeplion.
Croatian: Učinak pušenja na farmakokinetiku paliperidona nije ispitivan s lijekom Xeplion.
English: Of these, akathisia and sedation/somnolence appeared to be dose-related.
Croatian: Od navedenih nuspojava, pokazalo se da su akatizija i sedacija/somnolencija ovisne o dozi.
English: In case of severe extrapyramidal symptoms, anticholinergic agents should be administered.
Croatian: U slučaju jakih ekstrapiramidnih simptoma treba primijeniti antikolinergičke lijekove.
English: • are aware of having dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood.
Croatian: • ste svijesni da imate opasno nizak broj određene vrste bijelih krvnih stanica koja je potrebna za borbu protiv infekcije u krvi.
English: • sugar in the urine
Croatian: • šećer u mokraći