FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinically significant differences were observed between men and women.
Croatian: Nisu opažene klinički značajne razlike između muškaraca i žena.
English: For that reason, it is important to discuss with your doctor any of the following conditions which can potentially worsen during treatment with this medicine:
Croatian: Stoga je važno da sa svojim liječnikom porazgovarate o sljedećim bolestima koje se možda mogu pogoršati tijekom liječenja ovim lijekom:
English: This medicine will be given to you under medical supervision; it is, therefore, unlikely that you will be given too much.
Croatian: Ovaj ćete lijek primiti pod medicinskim nadzorom; stoga je malo vjerojatno da ćete dobiti preveliku dozu.
English: Schizophrenia is a disease with “positive” and “negative” symptoms.
Croatian: Shizofrenija je bolest s „pozitivnim” i „negativnim” simptomima.
English: Your doctor should regularly measure your body weight.
Croatian: Liječnik Vam redovito mora mjeriti tjelesnu težinu.
English: Overall mortality
Croatian: Ukupni mortalitet
English: The release of the active substance starts as early as day 1 and lasts for at least 4 months.
Croatian: Oslobađanje djelatne tvari počinje već prvog dana i traje najmanje 4 mjeseca.
English: • lack of emotion
Croatian: • nedostatak emocija
English: Dosing adjustments were only allowed in the first 12 weeks of the maintenance period.
Croatian: Prilagodba doze bila je dozvoljena samo u prvih 12 tjedana razdoblja održavanja.
English: Injury, poisoning and procedural complications fall
Croatian: Ozljede, trovanja i proceduralne komplikacije pad
English: If you are given more Xeplion than needed
Croatian: Ako primite više lijeka Xeplion nego što ste trebali
English: Elderly Efficacy and safety in elderly > 65 years have not been established.
Croatian: Starije osobe Djelotvornost i sigurnost primjene u osoba starijih od 65 godina nisu ustanovljene.
English: • high blood pressure
Croatian: • visoki krvni tlak
English: Shake the syringe vigorously for a minimum of 10 seconds to ensure a homogeneous suspension.
Croatian: Štrcaljku snažno tresite najmanje 10 sekundi kako biste dobili homogenu suspenziju.
English: Negative means a lack of behaviours or feelings that are normally present.
Croatian: Negativno znači izostanak ponašanja i osjećaja koji su normalno prisutni.
English: • tremor (shaking)
Croatian: • tremor (drhtanje)
English: General supportive measures should be employed.
Croatian: Potrebno je primijeniti opće potporne mjere.
English: Some patients may benefit from gradual withdrawal.
Croatian: Neki bolesnici mogu imati korist od postepenog prekida liječenja.
English: The difference is unlikely to be of clinical relevance.
Croatian: Ta razlika vjerojatno nije klinički relevantna.
English: ATC code: N05AX13
Croatian: ATK oznaka: N05AX13
English: Parkinson's disease and dementia with Lewy bodies
Croatian: Parkinsonova bolest i demencija s Lewyjevim tjelešcima
English: What Xeplion is and what it is used for
Croatian: Što je Xeplion i za što se koristi
English: If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.
Croatian: Ako je takva kombinacija neophodna, naročito u krajnjem stadiju Parkinsonove bolesti, trebalo bi propisati najnižu djelotvornu dozu svakog od lijekova.
English: Elderly patients with dementia
Croatian: Stariji bolesnici s demencijom
English: Patients with severe neutropenia (absolute neutrophil count < 1 x 10
Croatian: Bolesnici s teškom neutropenijom (apsolutni broj neutrofila < 1 x 10
English: This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
Croatian: To treba uzeti u obzir pri aktivnostima u kojima je potrebna puna budnost, npr. u vožnji ili upravljanju strojevima.
English: B-2340 Beerse Belgium
Croatian: B-2340 Beerse Belgija
English: Adjustment of the maintenance dose may be made monthly.
Croatian: Doza održavanja može se prilagođavati mjesečno.
English: Select the appropriate needle.
Croatian: Odaberite odgovarajuću iglu.
English: People with this disease may also feel depressed, anxious, guilty, or tense.
Croatian: Osobe koje boluju od ove bolesti također mogu biti depresivne, tjeskobne, napete ili osjećati krivnju.
English: You should not stop using this medicine unless told to do so by your doctor as your symptoms may return.
Croatian: Ne smijete prestati koristiti ovaj lijek osim ako Vam to nije rekao liječnik, jer se simptomi bolesti mogu vratiti.
English: Xeplion should then be continued at monthly intervals.
Croatian: Nakon toga Xeplion treba nastaviti primjenjivati u mjesečnim intervalima.
English: • excessive passing of gas or wind
Croatian: • prekomjerno izlaženje zraka ili vjetrovi
English: Each injection should be administered by a health care professional.
Croatian: Svaku injekciju treba primijeniti zdravstveni radnik.
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 zahtjevati promjenu Vaše doze ovog lijeka.
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 liječniku, jer će Vam možda htjeti prilagoditi dozu ili Vas neko vrijeme nadzirati.
English: Antiemetic effect
Croatian: Antiemetski učinak
English: This medicine may cause you to gain weight.
Croatian: Ovaj lijek može uzrokovati povećanje težine.
English: Children and adolescents This medicine is not for people who are under 18 years old.
Croatian: Ovaj lijek nije namijenjen za ljude mlađe od 18 godina.
English: Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to Xeplion is known.
Croatian: Stoga bolesnicima treba savjetovati da ne voze i ne upravljaju strojevima dok se ne ustanovi njihova osobna osjetljivost na Xeplion.
English: Nervous system disorders parkinsonism c,
Croatian: Poremećaji živčanog sustava parkinsonizam c,
English: The majority of these reactions were reported to be of mild to moderate severity.
Croatian: Većinom su te reakcije bile blage do umjerene.
English: The suspension is white to off-white.
Croatian: Suspenzija je bijele do gotovo bijele boje.
English: Similarly, the third and subsequent injections after the initiation regimen are recommended to be given monthly.
Croatian: Slično tome, preporučuje se da se treća i sljedeće injekcije nakon uvodnog režima doziranja primjenjuju mjesečno.
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: You should not use this medicine during pregnancy unless this has been discussed with your doctor.
Croatian: Ne smijete uzimati ovaj lijek u trudnoći ako o tome niste razgovarali sa svojim liječnikom.
English: It is important not to miss your scheduled dose.
Croatian: Važno je da ne propustite zakazanu dozu.
English: EU/1/11/672/001 (25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg) EU/1/11/672/004 (100 mg)
Croatian: EU/1/11/672/001 (25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg) EU/1/11/672/004 (100 mg) EU/1/11/672/005 (150 mg)
English: The relevance of these tumour findings in rodents in terms of human risk is unknown.
Croatian: Značaj ovih tumorskih nalaza kod glodavaca u smislu rizika za ljude nije poznat.
English: After the injection is complete, use either thumb or finger of one hand (8a, 8b) or a flat surface (8c) to activate the needle protection system.
Croatian: Nakon završetka injiciranja, palcem ili prstom jedne ruke (8a, 8b) ili ravnom površinom (8c) aktivirajte zaštitni sustav igle.
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics.
Croatian: Farmakoterapijska skupina: Psiholeptici, drugi antipsihotici.
English: For example, a person with schizophrenia may hear voices or see things that are not there (called hallucinations), believe things that are not true (called delusions), or feel unusually suspicious of others.
Croatian: Na primjer, osoba koja boluje od shizofrenije može čuti glasove ili vidjeti stvari koje nisu prisutne (to su halucinacije), vjerovati u stvari koje nisu istinite (to su deluzije), ili biti neobično sumnjičava prema drugima.
English: What you need to know before you use Xeplion
Croatian: Što morate znati prije nego počnete primjenjivati Xeplion
English: • abnormal coordination
Croatian: • nenormalna koordinacija
English: Safety data involving concomitant use of Xeplion with other antipsychotics is limited.
Croatian: Sigurnosni podaci koji uključuju istodobnu primjenu lijeka Xeplion s drugim antipsihoticima su ograničeni.
English: Xeplion should not be used during pregnancy unless clearly necessary.
Croatian: Xeplion se ne smije primjenjivati u trudnoći, osim ako to nije neophodno.
English: If you stop using Xeplion
Croatian: Ako prestanete primjenjivati Xeplion
English: What Xeplion is and what it is used for What you need to know before you use Xeplion How to use Xeplion
Croatian: Što je Xeplion i za što se koristi Što morate znati prije nego počnete primjenjivati Xeplion
English: The safety and efficacy of Xeplion in children and adolescents < 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Xeplion u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: • trouble breathing during sleep (sleep apnoea)
Croatian: • poteškoće s disanjem tijekom spavanja (apneja tijekom spavanja)
English: • eye infection
Croatian: • infekcija oka
English: Four metabolic pathways have been identified in vivo, none of which accounted for more than 6.5% 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 6,5% doze: dealkilacija, hidroksilacija, dehidrogenacija i razgradnja benzisoksazola.
English: • excessive drinking of water
Croatian: • prekomjerno pijenje vode
English: • decreased oxygen in parts of your body (because of decreased blood flow)
Croatian: • smanjenje kisika u dijelovima tijela (zbog smanjenja protoka krvi)
English: Very common side effects: may affect more than 1 in 10 people • difficulty falling or staying asleep.
Croatian: Vrlo česte nuspojave: mogu se pojaviti u više od 1 na 10 osoba • poteškoće s uspavljivanjem ili održavanjem sna.
English: • are a man and experience prolonged or painful erection.
Croatian: • ste muškarac i osjećate produljenu i bolnu erekciju.
English: The dose should not be given in divided injections.
Croatian: Doza se ne smije davati podijeljena na više injekcija.
English: • irritability, depression, anxiety
Croatian: • razdražljivost, depresija, tjeskoba
English: All medicines have side effects and some of the side effects of this medicine can worsen the symptoms of other medical conditions.
Croatian: Svi lijekovi imaju nuspojave, a neke od nuspojava ovog lijeka mogu pogoršati simptome drugih bolesti.
English: Because of the difference in median pharmacokinetic profiles between the two medicinal products, caution should be exercised when making a direct comparison of their pharmacokinetic properties.
Croatian: Zbog razlike u medijanima farmakokinetičkih profila dvaju lijekova, potreban je oprez kad se izravno uspoređuju njihova farmakokinetička svojstva.
English: If you stop receiving your injections, you will lose the effects of the medicine.
Croatian: Ako prestanete primati injekcije, djelovanje lijeka će se izgubiti.
English: Positive means an excess of symptoms that are not normally present.
Croatian: Pozitivno znači da su pretjerano izraženi simptomi koji normalno nisu prisutni.
English: • loss of menstrual periods
Croatian: • izostanak menstruacije
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 za 4 sata.
English: Extrapyramidal symptoms (EPS)
Croatian: Ekstrapiramidni simptomi (EPS)
English: The release profile and dosing regimen of Xeplion results in sustained therapeutic concentrations.
Croatian: Profil oslobađanja i režim doziranja lijeka Xeplion rezultiraju održanim terapijskim koncentracijama.
English: For example, a person with schizophrenia may appear withdrawn and may not respond at all emotionally or may have trouble speaking in a clear and logical way.
Croatian: Na primjer, osoba koja boluje od shizofrenije može se činiti povučenom i ne iskazivati nikakve emocionalne reakcije, ili može imati poteškoća da se jasno i logično izrazi.
English: It is also recommended to alternate between left and right sides (see below).
Croatian: Također se preporučuje primjenjivati lijek naizmjence u lijevu i desnu stranu (vidjeti u nastavku).
English: If your baby develops any of these symptoms you may need to contact your doctor.
Croatian: Ako kod djeteta primijetite pojavu bilo kojeg od ovih simptoma, možda ćete trebati kontaktirati liječnika.
English: No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Croatian: Nema podataka za bolesnike s teškim oštećenjem jetre (Child-Pugh stadij C).
English: Day 1
Croatian: 1. dan
English: If you are prone to develop convulsions, this medicine may increase your chance of experiencing them.
Croatian: Ako ste skloni nastanku konvulzija, ovaj lijek može povećati vjerojatnost da ih dobijete.
English: • low blood sugar
Croatian: • nizak šećer u krvi
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Xeplion.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Xeplion.
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 oko 11% u fecesu.
English: This medicine can pass from mother to baby through breast milk and may harm the baby.
Croatian: Ovaj se lijek kroz majčino mlijeko može prenijeti s majke na dojenče i naštetiti mu.
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: Ovaj lijek može sniziti krvni tlak, stoga je potreban oprez kad se primjenjuje zajedno s drugim lijekovima koji snižavaju krvni tlak.
English: It should be noted that a broader spectrum of symptoms are included that do not necessarily have an extrapyramidal origin.
Croatian: Potrebno je napomenuti da je uključen širi spektar simptoma koji ne moraju nužno biti ekstrapiramidnog porijekla.
English: Care must be taken to avoid inadvertent injection of Xeplion into a blood vessel.
Croatian: Treba paziti da se izbjegne nehotično injiciranje lijeka Xeplion u krvnu žilu.
English: Xeplion contains a racemic mixture of (+)- and (-)-paliperidone.
Croatian: Xeplion sadrži racemičnu smjesu (+) i (-) paliperidona.
English: • glaucoma (increased pressure within the eyeball)
Croatian: • glaukom (povišen tlak u očnoj jabučici)
English: Functioning was evaluated using the Personal and Social Performance (PSP) scale.
Croatian: Funkcioniranje bolesnika ocijenjeno je pomoću ljestvice osobnog i društvenog funkcioniranja (Personal and Social Performance, PSP).
English: The most commonly reported injection site related adverse reaction was pain.
Croatian: Najčešće zabilježena nuspojava povezana s mjestom primjene injekcije bila je bol.
English: Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
Croatian: Treba uspostaviti i održavati prohodnost dišnih puteva te osigurati odgovarajuću oksigenaciju i ventilaciju.
English: • sleep-related eating disorder
Croatian: • poremećaj hranjenja povezan sa spavanjem
English: • not moving or responding while awake (catatonia)
Croatian: • izostanak pokreta ili odgovora na poticaje u budnom stanju (katatonija)
English: Withdrawal of this medicine may be needed.
Croatian: Može biti potreban prestanak uzimanja ovog lijeka.
English: • Xeplion can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
Croatian: • Xeplion može podići razinu hormona koji se zove „prolaktin”, što se može vidjeti u krvnim pretragama (što može ili ne mora uzrokovati simptome).
English: Body mass index (BMI)/body weight
Croatian: Indeks tjelesne mase (ITM)/tjelesna težina
English: If you cannot keep your appointment with the doctor, make sure you call him right away so another appointment can be made as soon as possible.
Croatian: Ako ne možete doći u dogovoreno vrijeme, svakako odmah nazovite liječnika da što prije ugovorite novi termin.
English: Missed monthly maintenance dose (> 6 months)
Croatian: Propuštanje mjesečne doze održavanja (> 6 tjedana do 6 mjeseci)
English: The results of the other studies yielded statistically significant results in favour of Xeplion, except for the 50 mg dose in one study (see table below).
Croatian: Druga ispitivanja također su pokazala statistički značajne rezultate u korist lijeka Xeplion, osim za dozu od 50 mg u jednom ispitivanju (vidjeti donju tablicu).
English: The potential benefit of stopping alpha 1 blocking therapy prior to cataract surgery has not been established and must be weighed against the risk of stopping the antipsychotic therapy.
Croatian: Potencijalna korist od prekida liječenja alfa 1 blokatorima prije operacije katarakte nije utvrđena, te mora biti procijenjena u odnosu na rizik vezan uz prekid antipsihotičkog liječenja.
English: Paliperidone palmitate and paliperidone were not genotoxic.
Croatian: Paliperidonpalmitat i paliperidon nisu bili genotoksični.
English: Even though paliperidone is a strong D2-antagonist, which is believed to relieve the positive symptoms of schizophrenia, it causes less catalepsy and decreases motor functions less than traditional neuroleptics.
Croatian: Iako je paliperidon snažan antagonist D2-receptora, za koji se vjeruje da ublažava pozitivne simptome shizofrenije, on uzrokuje manju katalepsiju i manje smanjuje motoričke funkcije nego klasični neuroleptici.
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, otok grla, svrbež ili problemi s disanjem, jer to mogu biti znakovi ozbiljne alergijske reakcije.
English: If you have moderate or severe kidney problems this medicine should not be used.
Croatian: Ako imate umjereno ili teško oštećenje bubrega, ne biste smjeli dobivati ovaj lijek.
English: • inability to reach orgasm
Croatian: • nemogućnost postizanja orgazma
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xeplion in all subsets of the paediatric population in schizophrenia.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Xeplion u svim podskupinama pedijatrijske populacije sa shizofrenijom.
English: Other medicines and Xeplion 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: Adverse reactions that may suggest increase in prolactin levels (e.g., amenorrhoea, galactorrhoea, menstrual disturbances, gynaecomastia) were reported overall in < 1% of subjects.
Croatian: Nuspojave koje mogu ukazivati na porast razine prolaktina (npr. amenoreja, galaktoreja, poremećaj menstruacije i ginekomastija) ukupno su zabilježene u < 1% ispitanika.
English: While it can involve any part of the body (and may result in abnormal posture), dystonia often involves muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.
Croatian: Iako može uključiti bilo koji dio tijela (te može dovesti do nenormalnog držanja), distonija često uključuje mišiće lica, uz nenormalne pokrete očiju, usta, jezika ili čeljusti.
English: Therefore, alternatively, it could be considered to give deltoid injections for the first 6 months.
Croatian: Stoga se, alternativno, u obzir može uzeti primjena deltoidnih injekcija tijekom prvih 6 mjeseci.
English: The third dose should be administered one month after the second initiation dose.
Croatian: Treća doza mora se primijeniti mjesec dana nakon druge početne doze.
English: This medicine can reduce the effect of medicines against Parkinson's disease and restless legs syndrome (e.g., levodopa).
Croatian: Ovaj lijek može umanjiti djelovanje lijekova protiv Parkinsonove bolesti i sindroma nemirnih nogu (npr. levodope).
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 i zdravstvenim radnicima koji ih moraju pročitati zajedno sa potpunim podacima za propisivanje lijeka (sažetak opisa svojstava lijeka).
English: In general, recommended dosing of Xeplion for elderly patients with normal renal function is the same as for younger adult patients with normal renal function.
Croatian: Općenito, preporučene doze lijeka Xeplion za starije bolesnike s normalnom bubrežnom funkcijom iste su kao i za mlađe odrasle bolesnike s normalnom bubrežnom funkcijom.
English: Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive by one dose level at the time of your scheduled monthly injection.
Croatian: Ovisno o simptomima, liječnik Vam kod sljedeće mjesečne injekcije može povisiti ili sniziti količinu lijeka koji primate za jednu jačinu doze.
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 i kontinuirano elektrokardiografsko praćenje kako bi se uočile moguće aritmije.
English: Figure 1: Kaplan-Meier Plot of Time to Relapse - Interim Analysis (Intent-to-Treat Interim Analysis Set)
Croatian: Slika 1:Kaplan-Meierova procjena vremena do ponovnog relapsa - interim analiza (niz interim analiza u populaciji koja se namjeravala liječiti)
English: Leucopenia, neutropenia, and agranulocytosis
Croatian: Leukopenija, neutropenija i agranulocitoza
English: • low blood pressure, low blood pressure upon standing (consequently, some people taking this medicine may feel faint, dizzy, or may pass out when they stand up or sit up suddenly)
Croatian: • nizak krvni tlak, nizak krvni tlak nakon ustajanja (kao posljedica toga, neki ljudi koji uzimaju ovaj lijek mogu osjećati nesvjesticu, omaglicu ili se mogu onesvijestiti nakon što iznenada ustanu ili sjednu)
English: There was a statistically significant increase in mammary gland adenocarcinomas in female rats at 10, 30 and 60 mg/kg/month.
Croatian: Utvrđen je statistički značajan porast broja adenokarcinoma mliječnih žlijezda u ženki štakora pri dozama od 10, 30 i 60 mg/kg/mjesec.
English: Acute treatment of schizophrenia
Croatian: Akutno liječenje shizofrenije
English: Caution is recommended if paliperidone is used in such patients.
Croatian: Preporučuje se oprez ako se paliperidon primjenjuje u takvih bolesnika.
English: Therefore, you should not breastfeed when using this medicine.
Croatian: Stoga ne smijete dojiti dok primate ovaj lijek.
English: No in vivo data are available and the clinical relevance is unknown.
Croatian: Nisu dostupni podaci in vivo i nije utvrđena klinička relevantnost.