FrancophonIA/ELRC3.0 huggingface dataset:
English: • leakage of milk from the breasts
Croatian: • curenje mlijeka iz dojki
English: Concomitant use of Xeplion with psychostimulants
Croatian: Istodobna primjena lijeka Xeplion sa psihostimulansima
English: • breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
Croatian: • pucanje mišićnih vlakana i bol u mišićima (rabdomioliza)
English: No interaction study between Xeplion and lithium has been performed, however, a pharmacokinetic interaction is not likely to occur.
Croatian: Nisu provedena ispitivanja interakcija između lijeka Xeplion i litija; međutim, nije vjerojatna pojava farmakokinetičke interakcije.
English: Since this medicine may reduce your urge to vomit, there is a chance that it may mask the body's normal response to ingestion of toxic substances or other medical conditions.
Croatian: Budući da ovaj lijek može smanjiti nagon na povraćanje, postoji mogućnost da prikrije normalan odgovor organizma na unos otrovnih tvari ili druge bolesti.
English: The PSP is a validated clinician rated scale that measures personal and social functioning in four domains: socially useful activities (work and study), personal and social relationships, self-care and disturbing and aggressive behaviours.
Croatian: Ljestvica PSP je validirana ljestvica koju ispunjava liječnik, a koja mjeri osobno i društveno funkcioniranje u četiri područja: društveno korisne aktivnosti (rad i učenje), osobne i društvene veze, briga za sebe te disruptivno i agresivno ponašanje.
English: • inappropriate secretion of a hormone that controls urine volume
Croatian: • neprimjereno lučenje hormona koji kontrolira volumen mokraće
English: • priapism (a prolonged penile erection that may require surgical treatment)
Croatian: • prijapizam (produljena erekcija penisa koja može zahtijevati operativni zahvat)
English: • atrial fibrillation (an abnormal heart rhythm), irregular heart beat
Croatian: • atrijska fibrilacija (nenormalan srčani ritam), nepravilni otkucaji srca
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 može imati mali ili umjereni utjecaj 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: Xeplion should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Croatian: Xeplion se mora koristiti uz oprez s lijekovima koji povećavaju aktivnost središnjeg živčanog sustava (psihostimulansi, primjerice metilfenidat).
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including paliperidone, should be considered.
Croatian: Ako se pojave znakovi i simptomi tardivne diskinezije, treba razmotriti prekid primjene svih antipsihotika, uključujući i paliperidon.
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 uzrokovanja predoziranja većim brojem lijekova.
English: Use in patients who are in an acutely agitated or severely psychotic state
Croatian: Primjena u bolesnika u stanju akutne agitacije ili teškog psihotičnog stanja
English: Date of first authorisation: 04 March 2011 Date of latest renewal: 16 December 2015
Croatian: Datum zadnje obnove odobrenja: 16. prosinca 2015.
English: There were no relevant effects observed in the non-clinical studies.
Croatian: U nekliničkim ispitivanjima nisu opaženi relevantni učinci.
English: Xeplion is intended for intramuscular use only.
Croatian: Xeplion je namijenjen samo za intramuskularnu primjenu.
English: The pharmacological activity of the (+)- and (-)-paliperidone enantiomers are qualitatively and quantitatively similar.
Croatian: Farmakološko djelovanje (+) i (-) enantiomera paliperidona je kvalitativno i kvantitativno slično.
English: • a reaction at the injection site, including itching, pain or swelling.
Croatian: • reakcija na mjestu injekcije, uključujući svrbež, bol ili oticanje.
English: The primary efficacy endpoint was defined as a decrease in Positive and Negative Syndrome Scale (PANSS) total scores as shown in the table below.
Croatian: Primarna mjera ishoda djelotvornosti definirana je kao smanjenje rezultata na ljestvici pozitivnih i negativnih simptoma shizofrenije (Positive and Negative Syndrome Scale, PANSS), ukupan zbroj prikazan je u tablici ispod.
English: Physicians should weigh the risks versus the benefits when prescribing Xeplion 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 Xeplion bolesnicima s Parkinsonovom bolešću ili demencijom s Lewyjevim tjelešcima jer obje skupine mogu imati povećan rizik razvoja malignog neuroleptičkog sindroma kao i povećanu osjetljivost na antipsihotike.
English: • serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing
Croatian: • ozbiljna alergijska reakcija praćena oticanjem, koja može uključiti grlo i dovesti do otežanog disanja
English: This interaction has not been studied with Xeplion.
Croatian: Ova interakcija nije ispitivana s lijekom Xeplion.
English: Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents.
Croatian: Hipotenziju i cirkulatorni kolaps treba liječiti odgovarajućim mjerama kao što su intravenska nadoknada tekućine i/ili simpatomimetici.
English: Gradual withdrawal of stimulant treatment is recommended (see section 4.5).
Croatian: Preporučeno je postupno ukidanje liječenja psihostimulansima (vidjeti dio 4.5).
English: What Xeplion contains
Croatian: Što Xeplion sadrži
English: There is no specific antidote to paliperidone.
Croatian: Ne postoji specifični antidot za paliperidon.
English: This medicine may cause an electrocardiogram (ECG) abnormality demonstrating a long time for an electrical impulse to travel through a certain part of the heart (known as “QT prolongation”).
Croatian: Ovaj lijek može uzrokovati abnormalnost elektrokardiograma (EKG-a), koja se očituje produženim vremenom provođenja električnog impulsa kroz neke dijelove srca (naziva se „produljenje QT intervala”).
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 moguće vrućice ili drugih simptoma ili znakova infekcije, te ih hitno liječiti u slučaju pojave takvih simptoma ili znakova.
English: It is recommended that the second initiation dose of Xeplion be given one week after the first dose.
Croatian: Preporučuje se primijeniti drugu početnu dozu lijeka Xeplion tjedan dana nakon prve doze.
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, possible side effects).
Croatian: Međutim, kod starijih bolesnika s demencijom koji se liječe drugim sličnim lijekovima može biti povećan rizik od moždanog udara ili smrti (vidjeti dio 4. Moguće nuspojave).
English: When making dose adjustments, the prolonged release characteristics of Xeplion should be considered (see section 5.2), as the full effect of maintenance doses may not be evident for several months.
Croatian: Kod prilagodbe doze treba uzeti u obzir da je Xeplion lijek s produljenim oslobađanjem (vidjeti dio 5.2) te puni učinak doza održavanja možda neće biti vidljiv nekoliko mjeseci.
English: Paliperidone may antagonise the effect of levodopa and other dopamine agonists.
Croatian: Paliperidon može antagonizirati učinak levodope i drugih dopaminskih agonista.
English: However, because elderly patients may have diminished renal function, dose adjustment may be necessary (see Renal impairment below for dosing recommendations in patients with renal impairment).
Croatian: Međutim, budući da stariji bolesnici mogu imati oslabljenu bubrežnu funkciju, može biti potrebna prilagodba doze (vidjeti odjeljak Oštećenje bubrega ispod za preporuke o doziranju u bolesnika s oštećenjem bubrega).
English: One week following administration of a single oral dose of 1 mg immediate-release
Croatian: Tjedan dana po uzimanju jedne oralne doze od 1 mg
English: There are no adequate data from the use of paliperidone during pregnancy.
Croatian: Nema adekvatnih podataka o primjeni paliperidona u trudnoći.
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 ljestvica validirani je upitnik s više čestica koji se sastoji od pet faktora za procjenu pozitivnih simptoma, negativnih simptoma, neorganiziranih misli, nekontroliranog neprijateljskog ponašanja/uzbuđenja te anksioznosti/depresije.
English: In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicinal products 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: Elimination of paliperidone decreased with decreasing estimated creatinine clearance.
Croatian: Uklanjanje paliperidona se smanjilo sukladno smanjenju procijenjenog klirensa kreatinina.
English: • high blood sugar, weight gain, weight loss, decreased appetite
Croatian: • visok šećer u krvi, porast težine, gubitak težine, smanjen tek
English: • dangerously excessive intake of water
Croatian: • opasno prekomjerni unos vode
English: The suspension for injection is for single use only.
Croatian: Suspenzija za injekciju namijenjena je samo za jednokratnu primjenu.
English: • are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
Croatian: • planirate operaciju oka, svakako obavijestite svoga liječnika oftalmologa da uzimate ovaj lijek.
English: Since this medicine works primarily in the brain, interference from 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, utjecaj 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: Other injection site reactions were mostly mild in intensity and included induration (common), pruritus (uncommon) and nodules (rare).
Croatian: Druge reakcije na mjestu primjene bile su većinom blage, a obuhvaćale su induraciju (često), pruritus (manje često) i čvoriće (rijetko).
English: • yellowing of the skin and the eyes (jaundice)
Croatian: • žuta boja kože i očiju (žutica)
English: During an operation on the eye for cloudiness of the lens (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed.
Croatian: Tijekom operacije oka zbog zamućenja leće (katarakta), zjenica (crni krug u sredini oka) se možda neće proširiti onoliko koliko je potrebno.
English: • loss of appetite resulting in malnutrition and low body weight
Croatian: • gubitak teka koji za posljedicu ima pothranjenost i nisku tjelesnu težinu
English: • diabetes or worsening of diabetes, increased insulin (a hormone that controls blood sugar levels)
Croatian: • šećerna bolest ili pogoršanje postojeće šećerne bolesti, povišen inzulin (hormon koji kontrolira razinu šećera u krvi) u krvi
English: Following administration of paliperidone palmitate the (+) and (-) enantiomers of paliperidone interconvert, reaching an AUC (+) to (-) ratio of approximately 1.6-1.8.
Croatian: Nakon primjene paliperidonpalmitata (+) i (-) enantiomeri paliperidona se međusobno pretvaraju, tako da omjer AUC između (+) i (-) enantiomera iznosi otprilike 1,6-1,8.
English: • an increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes released with muscle breakdown
Croatian: • povišen CPK (kreatin fosfokinaza) u krvi, enzim koji se ponekad oslobađa prilikom pucanja mišića
English: Overall incidence from all clinical trials was 0.65% in all paliperidone palmitate -treated subjects
Croatian: Ukupna incidencija iz svih kliničkih ispitivanja bila je 0,65% kod svih ispitanika liječenih paliperidonpalmitatom
English: • coma due to uncontrolled diabetes
Croatian: • koma radi nekontrolirane šećerne bolesti
English: Occasionally abscess formation occurred.
Croatian: Ponekad je došlo do stvaranja apscesa.
English: Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face.
Croatian: Odmah obavijestite liječnika ako osjetite nevoljne ritmične pokrete jezika, usta ili lica.
English: Immediate medical treatment may be needed.
Croatian: Može biti potrebna neodgodiva medicinska pomoć.
English: • sleep disorder, elated mood (mania), decreased sexual drive, nervousness, nightmares
Croatian: • poremećaj spavanja, ushićeno raspoloženje (manija), smanjena spolna želja, nervoza, noćne more
English: Paliperidone is a selective blocking agent of monoamine effects, whose pharmacological properties are different from that of traditional neuroleptics.
Croatian: Paliperidon je selektivni blokator djelovanja monoamina, čija se farmakološka svojstva razlikuju od klasičnih neuroleptika.
English: The plasma protein binding of racemic paliperidone is 74%.
Croatian: Vezanje racemičnog paliperidona na proteine u plazmi iznosi 74%.
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: • white blood cell count decreased, decrease in the type of white blood cells that help to protect you against infection, decrease in platelets (blood cells that help you stop bleeding), anaemia
Croatian: • smanjen broj bijelih krvnih stanica, smanjen broj vrste bijelih krvnih stanica koje pomažu u borbi protiv infekcije, smanjen broj trombocita (krvne stanice koje pomažu pri zaustavljanju krvarenja), anemija
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: Paliperidone binds strongly to serotonergic 5-HT2and dopaminergic D2-receptors.
Croatian: Paliperidon se snažno veže na serotoninske 5-HT2 i dopaminske D2 receptore.
English: Xeplion injection
Croatian: Injekcija lijeka Xeplion
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 promjenu u mentalnom stanju ili iznenadnu slabost ili obamrlost lica, ruku ili nogu, naročito jedne strane, ili nerazumljivo pričate, čak i kratko vrijeme.
English: Smoking status
Croatian: Pušački status
English: If hypersensitivity reactions occur, discontinue use of Xeplion; initiate general supportive measures as clinically appropriate and monitor the patient until signs and symptoms resolve (see sections 4.3 and
Croatian: Ako se pojave reakcije preosjetljivosti, primjenu lijeka Xeplion treba prekinuti; započeti opće suportivne mjere kako je klinički prikladno i pratiti bolesnika dok se znakovi i simptomi ne povuku (vidjeti dijelove 4.3 i 4.8).
English: If you have mild kidney problems your doctor may give you a lower dose.
Croatian: Ako imate blago oštećenje bubrega, liječnik Vam može dati nižu dozu lijeka.
English: The carcinogenic potential of intramuscularly injected paliperidone palmitate was assessed in rats.
Croatian: Kancerogeni potencijal intramuskularno primijenjenog paliperidonpalmitata istražen je na štakorima.
English: In clinical trials, median increases in serum prolactin were observed in subjects of both genders who received Xeplion.
Croatian: U kliničkim ispitivanjima zabilježen je porast medijana razine serumskog prolaktina u ispitanika oba spola koji su primali Xeplion.
English: • life threatening complications of uncontrolled diabetes
Croatian: • po život opasne komplikacije nekontrolirane šećerne bolesti
English: Xeplion is also available in a Treatment initiation pack which contains two pre-filled syringes (150 mg + 100 mg) and 2 additional safety needles.
Croatian: Xeplion je dostupan i u pakiranju za početak liječenja koje sadrži dvije napunjene štrcaljke (150 mg + 100 mg) i 2 dodatne sigurnosne igle.
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 Xeplion (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 Xeplion (vidjeti dio 4.8).
English: Hypersensitivity to the active substance, to risperidone or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, na risperidon ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Croatian: Savjetuje se odgovarajuće kliničko praćenje, sukladno uobičajenim smjernicama primjene antipsihotika.
English: • very low body temperature, chills, feeling thirsty
Croatian: • vrlo niska tjelesna temperatura, zimica, osjećaj žeđi
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 (ChildPugh stadij B), plazmatske koncentracije slobodnog paliperidona bile su slične kao u zdravih osoba.
English: You will receive the first injection (150 mg) and second injection (100 mg) of this medicine in the upper arm approximately one week apart.
Croatian: Prvu injekciju (150 mg) i drugu injekciju (100 mg) ovog lijeka primit ćete u nadlakticu, u razmaku od oko tjedan dana.
English: For instructions for use and handling of Xeplion, see package leaflet (information intended for medical or healthcare professionals).
Croatian: Upute za primjenu i rukovanje lijekom Xeplion navedene su u Uputi o lijeku (informacije namijenjene samo zdravstvenim radnicima).
English: • experience fever, muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”).
Croatian: • osjetite vrućicu, ukočenost mišića, znojenje ili smanjenu razinu svijesti (poremećaj koji se naziva „neuroleptički maligni sindrom”).
English: To avoid a missed monthly dose, patients may be given the injection up to 7 days before or after the monthly time point.
Croatian: Kako bi se spriječilo propuštanje mjesečne doze, bolesniku se injekcija može dati do 7 dana prije ili nakon roka od mjesec dana.
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 studijama nije ustanovljena jasna poveznica s primjenom antipsihotika, preporučuje se oprez u bolesnika s relevantnom poviješću bolesti.
English: In placebo-controlled trials, diabetes mellitus was reported in 0.32% in Xeplion-treated subjects 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 lijekom Xeplion u usporedbi sa stopom od 0,39% u placebo skupini.
English: Conversely, on discontinuation of carbamazepine, the dose of Xeplion should be re-evaluated and decreased if necessary.
Croatian: Obrnuto, kad se karbamazepin ukida, dozu lijeka Xeplion trebalo bi ponovno procijeniti i po potrebi sniziti.
English: • increased liver transaminases in your blood
Croatian: • povišene jetrene transaminaze u krvi
English: The frequency of these adverse reactions is qualified as “not known” because they were not observed in paliperidone palmitate clinical trials.
Croatian: Učestalost ovih nuspojava je određena kao „nepoznato” jer nisu bile zabilježene u kliničkim ispitivanjima s paliperidonpalmitatom.
English: To avoid a missed dose, patients may be given the second dose 4 days before or after the one-week (day 8) time point.
Croatian: Kako bi se spriječilo propuštanje doze, bolesniku se druga doza može dati 4 dana prije ili 4 dana nakon roka od jednog tjedna (8. dana).
English: • sensation of spinning (vertigo), ringing in the ears, ear pain
Croatian: • osjećaj vrtnje (vertigo), zvonjenje u ušima, bol u uhu
English: Pharmacokinetic studies with paliperidone palmitate have shown somewhat lower (10-20%) plasma concentrations of paliperidone in patients who are overweight or obese in comparison with normal weight patients (see section 4.2).
Croatian: Farmakokinetička ispitivanja paliperidonpalmitata pokazala su nešto niže (10-20%) plazmatske koncentracije paliperidona u bolesnika s povećanom tjelesnom težinom i pretilih bolesnika u usporedbi s bolesnicima normalne tjelesne težine (vidjeti dio 4.2).
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 oralne formulacije i one koje se primjenjuju injekcijom) međusobno povezan.
English: Refer to ‘Hyperprolactinaemia' below.
Croatian: Vidjeti „Hiperprolaktinemija” niže.
English: Due to its extremely low water solubility, paliperidone palmitate dissolves slowly after intramuscular injection before being hydrolysed to paliperidone and absorbed into the systemic circulation.
Croatian: Zbog izuzetno slabe topljivosti u vodi, paliperidonpalmitat se nakon intramuskularne injekcije sporo otapa prije nego se hidrolizira u paliperidon i apsorbira u sistemsku cirkulaciju.
English: Potential for other medicines to affect Xeplion
Croatian: Mogućnost djelovanja drugih lijekova na Xeplion
English: Undesirable effects noted with risperidone formulations
Croatian: Nuspojave zabilježene s formulacijama risperidona
English: • high blood triglycerides (a fat), increased cholesterol in your blood
Croatian: • visoki trigliceridi u krvi (masnoća), povišen kolesterol u krvi
English: In this study, doses of Xeplion included 25, 50, 75, and 100 mg administered monthly; the 75 mg dose was allowed only in the 52-week open-label extension.
Croatian: U ispitivanju su korištene doze lijeka Xeplion od 25, 50, 75 i 100 mg, koje su primijenjene mjesečno; doza od 75 mg bila je dozvoljena samo u 52-tjednom otvorenom nastavku ispitivanja.
English: Refer to ‘Extrapyramidal symptoms' below.
Croatian: Vidjeti „Ekstrapiramidni simptomi” niže.
English: If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
Croatian: Ukoliko imate u planu operaciju oka, svakako obavijestite svoga liječnika oftalmologa da uzimate ovaj lijek.