FrancophonIA/ELRC3.0 huggingface dataset:
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Croatian: U nekim slučajevima, prijavljeno je prethodno povećanje tjelesne težine, što bi moglo biti predisponirajući čimbenik.
English: • sugar in the urine
Croatian: • šećer u urinu
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: Ukoliko je takva kombinacija neophodna, posebice u zadnjem stadiju Parkinsonove bolesti, treba propisati najnižu djelotvornu dozu svakog od lijekova.
English: Overall mortality
Croatian: Opća smrtnost
English: It takes 2-3 weeks for full induction to be achieved and upon discontinuation of the inducer the effect wears off over a similar time period.
Croatian: Potrebno je 2-3 tjedna za postizanje potpune indukcije, a po prestanku uzimanja induktora učinak nestaje tijekom sličnog razdoblja.
English: Since this medicine can lower blood pressure, care should be taken when this medicine is taken with other medicines that lower blood pressure.
Croatian: Budući da ovaj lijek može sniziti krvni tlak, potreban je oprez kad se ovaj lijek primjenjuje zajedno s drugim lijekovima koji snižavaju krvni tlak.
English: Talk to your doctor, pharmacist or nurse before taking INVEGA.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete INVEGU.
English: What you need to know before you take INVEGA
Croatian: Što morate znati prije nego počnete uzimati INVEGU
English: An examination of population subgroups did not reveal any evidence of differential responsiveness on the basis of gender, age, or geographic region.
Croatian: Pregled populacijskih podskupina nije otkrio ni jedan dokaz različitog odgovora na temelju spola, godina ili zemljopisne regije.
English: Antiemetic effect
Croatian: Antiemetički učinak
English: - if you have liver problems.
Croatian: - ako imate jetrene probleme.
English: Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to INVEGA is known.
Croatian: Stoga bolesnike treba savjetovati da ne voze ili ne upravljaju strojevima sve dok se ne utvrdi njihova osobna osjetljivost na lijek INVEGA.
English: Paliperidone is rapidly distributed.
Croatian: Paliperidon se distribuira vrlo brzo.
English: You should not take this medicine during pregnancy unless this has been discussed with your doctor.
Croatian: Ne smijete uzimati ovaj lijek tijekom trudnoće ako niste o tome razgovarali s Vašim liječnikom.
English: Subjects were 12-17 years of age and met DSM-IV criteria for schizophrenia.
Croatian: Ispitanici su imali 12-17 godina i zadovoljili su DSM-IV kriterije za shizofreniju.
English: Date of first authorisation: 25 June 2007 Date of latest renewal: 14 May 2012
Croatian: Datum posljednje obnove: 14. svibnja 2012.
English: - if you have prolonged and/or painful erection.
Croatian: - ako imate produljenu i/ili bolnu erekciju.
English: No in vivo data are available and the clinical relevance is unknown.
Croatian: In vivo podatci nisu dostupni i nije poznata klinička relevantnost.
English: - if you have difficulty controlling core body temperature or overheating.
Croatian: - ako imate poteškoća s reguliranjem osnovne tjelesne temperature ili pregrijavanjem.
English: This medicine must be taken by mouth, swallowed whole with water or other liquids.
Croatian: Ovaj lijek mora se uzeti kroz usta i treba ga progutati u cijelosti, s vodom ili drugom tekućinom.
English: In adolescents, weight gain should be assessed against that expected with normal growth.
Croatian: U adolescenata, povećana tjelesna težina mora se procijeniti u odnosu na očekivanu uz normalan rast.
English: - if you have heart disease or heart disease treatment that makes you prone to low blood pressure.
Croatian: - ako ste srčani bolesnik ili liječite srčanu bolest što Vas čini sklonim niskom krvnom tlaku.
English: What INVEGA is and what it is used for What you need to know before you take INVEGA How to take INVEGA
Croatian: Što je INVEGA i za što se koristi Što morate znati prije nego počnete uzimati INVEGU
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 i 11% u fecesu.
English: Note: Negative change in score indicates improvement.
Croatian: Napomena: Negativna promjena rezultata pokazuje poboljšanje.
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: There were insufficient data to explore differential effects based on race.
Croatian: Nije bilo dovoljno podataka za istraživanje različite djelotvornost vezane uz rasu.
English: The population included subjects with schizoaffective bipolar and depressive types.
Croatian: Populacija je uključivala shizoafektivne bipolarne i depresivne tipove ispitanika.
English: Your doctor will decide how much to give you.
Croatian: Vaš liječnik će odlučiti koliko lijeka ćete dobiti.
English: People with this disorder may also feel depressed, anxious, guilty, or tense.
Croatian: Ljudi koji boluju od ove bolesti također se mogu osjećati depresivno, tjeskobno, mogu imati osjećaj krivnje ili napetosti.
English: The terminal elimination half-life of paliperidone is about 23 hours.
Croatian: Terminalni poluvijek eliminacije paliperidona iznosi oko 23 sata.
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 nijednim nije prošlo više od 6,5% doze: dealkilacija, hidroksilacija, dehidrogenacija i razgradnja benzisoksazola.
English: Fertility There were no relevant effects observed in the non-clinical studies.
Croatian: Plodnost Nema relevantnih učinaka primijećenih u nekliničkim ispitivanjima.
English: The dose may be increased to 6 mg once daily based on clinical response and tolerability.
Croatian: Doza se može povećati na 6 mg jedanput na dan ovisno o kliničkom odgovoru i toleranciji.
English: Biotransformation and elimination One week following administration of a single oral dose of 1 mg immediate-release
Croatian: Biotransformacija i eliminacija Tjedan dana po uzimanju jedne oralne doze 1 mg
English: For specific posology recommendations in the paediatric population see section 4.2.
Croatian: Za specifične preporuke doziranja u pedijatrijskoj populaciji vidjeti dio 4.2.
English: • very low body temperature, a decrease in body temperature
Croatian: • vrlo niska tjelesna temperatura, sniženje tjelesne temperature
English: • loss of menstrual periods
Croatian: • gubitak menstrualnog ciklusa
English: INVEGA can help alleviate the symptoms of your disease and stop your symptoms from coming back.
Croatian: INVEGA vam može pomoći pri ublažavanju simptoma bolesti, te može spriječiti ponovnu pojavu simptoma.
English: At 2.5 mg/kg/day in females, an effect on learning and memory was observed.
Croatian: Pri dozama od 2,5 mg/kg/dan u ženki, bio je zapažen učinak na učenje i pamćenje.
English: Do not alternate between taking this medicine with breakfast one day and without having breakfast the next day.
Croatian: Nemojte izmjenjivati način uzimanja ovog lijeka i ne uzimajte ga jedan dan uz doručak, a drugi dan natašte.
English: • leaking milk from the breasts in girls
Croatian: • curenje mlijeka iz dojki kod djevojaka
English: Aripiprazole 5-15 mg N=114
Croatian: Aripiprazol 5-15 mg N=114
English: • trouble breathing during sleep (sleep apnea), fast, shallow breathing
Croatian: • poteškoće s disanjem tijekom spavanja (apneja tijekom spavanja), brzo, plitko disanje
English: The 3 mg tablet of this medicine contains lactose, a type of sugar.
Croatian: Tableta ovog lijeka od 3 mg sadrži laktozu, jednu vrstu šećera.
English: The safety profile of risperidone may be pertinent.
Croatian: Sigurnosni profil risperidona može biti primjenjiv.
English: Paliperidone was not teratogenic in animal studies, but other types of reproductive toxicity were observed (see section 5.3).
Croatian: U ispitivanjima na životinjama paliperidon nije bio teratogen, no uočene su druge vrste reproduktivne toksičnosti (vidjeti dio 5.3).
English: INVEGA contains a racemic mixture of (+)- and (-)-paliperidone.
Croatian: INVEGA sadrži racemičnu smjesu (+) i (-) paliperidona.
English: Patients should be informed to seek urgent medical care in case that priapism has not been resolved within 3-4 hours.
Croatian: Bolesnicima se savjetuje da potraže hitnu medicinsku pomoć u slučaju da prijapizam ne prođe unutar 3-4 sata.
English: Administration of activated charcoal together with a laxative should be considered.
Croatian: Treba razmotriti primjenu aktivnog ugljena zajedno s laksativom.
English: Association with ketoacidosis has been reported very rarely and rarely with diabetic coma.
Croatian: Povezanost s ketoacidozom prijavljena je vrlo rijetko, a rijetko s dijabetičkom komom.
English: All tested doses of INVEGA separated from placebo on day 4 (p < 0.05).
Croatian: Sve su se ispitivane doze INVEGE razlikovale od placeba na 4. dan (p < 0,05).
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 jasna povezanost s primjenom antipsihotika do sada nije bila pokazana u kliničkim i epidemiološkim ispitivanjima, preporučen je oprez kod bolesnika s relevantnom poviješću bolesti.
English: In the case of acute overdosage, the possibility of multiple medicinal product involvement should be considered.
Croatian: U slučaju akutnog predoziranja mora se uzeti u obzir mogućnost predoziranja većim brojem lijekova.
English: You should not stop this medicine unless told to do so by your doctor as your symptoms may return.
Croatian: Ne smijete prestati uzimati ovaj lijek, osim ako Vam to nije rekao liječnik, jer se simptomi bolesti mogu vratiti.
English: The pharmacological activity of the (+)- and (-)-paliperidone enantiomers are qualitatively and quantitatively similar.
Croatian: Farmakološka aktivnost (+) i (-) enantiomera paliperidona je kvalitativno i kvantitativno slična.
English: Blisters: Do not store above 30°C.
Croatian: Blisteri: Ne čuvati na temperaturi iznad 30°C.
English: • INVEGA can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
Croatian: • INVEGA može podići razinu hormona koji se zove „prolaktin” što se vidi u krvnim pretragama (što može ili ne mora uzrokovati simptome).
English: If your baby develops any of these symptoms you may need to contact your doctor.
Croatian: Ako se kod Vaše bebe pojavi neki od navedenih simptoma, možda ćete se morati javiti liječniku.
English: Only few subjects received the 3 mg dose in both studies and efficacy of this dose could not be established.
Croatian: Svega nekoliko ispitanika je primilo dozu od 3 mg u oba ispitivanja i djelotvornost ove doze se nije mogla ustanoviti.
English: Predefined secondary endpoints included the Personal and Social Performance (PSP) scale and the Clinical Global Impression - Severity (CGI-S) scale.
Croatian: Unaprijed definirane sekundarne mjere ishoda uključivale su skalu procjene osobnog i društvenog funkcioniranja (Personal and Social Performance PSP) i skalu procjene ozbiljnosti kliničkog stanja bolesti (Clinical Global Impressionseverity CGI-S).
English: If discontinuation during pregnancy is necessary, it should not be done abruptly.
Croatian: Ukoliko je potreban prekid liječenja tijekom trudnoće, ne smije se izvršiti naglo.
English: Take this medicine exactly as the doctor, pharmacist or nurse has told you to.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik, ljekarnik ili medicinska sestra.
English: Efficacy was evaluated using PANSS.
Croatian: Djelotvornost je procijenjena koristeći PANSS.
English: Eye problems during cataract surgery may also occur.
Croatian: Jednako tako može doći do problema s okom tijekom operacije katarakte.
English: The administration of INVEGA should be standardised in relation to food intake (see section 5.2).
Croatian: Uzimanje INVEGE treba biti standardizirano u odnosu na uzimanje hrane (vidjeti dio 5.2).
English: • loss of consciousness, balance disorder, abnormal coordination
Croatian: • gubitak svijesti, poremećaj ravnoteže, nenormalna koordinacija
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 opreacije oka zbog zamućenja leće (katarakta), zjenica (crni krug u sredini oka) se možda neće proširiti onoliko koliko je potrebno.
English: * Medium dose group: 3 mg for subjects < 51 kg, 6 mg for subjects ≥ 51 kg ** High dose group: 6 mg for subjects < 51 kg, 12 mg for subjects ≥ 51 kg
Croatian: *Skupina srednje doze: 3 mg za ispitanike < 51 kg, 6 mg za ispitanike ≥ 51 kg **Skupina visoke doze: 6 mg za ispitanike < 51 kg, 12 mg za ispitanike ≥ 51 kg
English: Parkinson's disease and dementia with Lewy bodies Physicians should weigh the risks versus the benefits when prescribing INVEGA 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: Parkinsonova bolest i demencija s Lewyjevim tjelešcima Liječnici trebaju procijeniti koliko korisni učinci nadilaze rizike pri propisivanju lijeka INVEGA bolesnicima s Parkinsonovom bolešću ili demencijom s Lewijevim tjelešcima (DLB) jer obje skupine mogu imati povećan rizik razvoja malignog neuroleptičkog sindroma kao i povećanu osjetljivost na antipsihotike.
English: LOCF = last observation carried forward.
Croatian: LOCF = (last observation carried forward) metoda prijenosa vrijednosti posljednjeg zapažanja dalje.
English: Bottles: Do not store above 30°C.
Croatian: Boce: Ne čuvati na temperaturi iznad 30°C.
English: This medicine can reduce the effect of medicines against Parkinson's disease and restless legs syndrome (e.g., levodopa).
Croatian: Ovaj lijek može smanjiti učinak lijekova za Parkinsonovu bolest i sindrom nemirnih nogu (npr. levodopa).
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 i čeljusti.
English: • increased insulin (a hormone that controls blood sugar levels) in your blood.
Croatian: • povišen inzulin (hormon koji kontrolira razinu šećera u krvi) u krvi.
English: Other medicines and INVEGA
Croatian: Drugi lijekovi i INVEGA
English: Dosage adjustment, if indicated, should occur only after clinical reassessment based on the individual need of the patient.
Croatian: Prilagodba doze, ukoliko je indicirana, mora se provesti samo nakon ponovne kliničke procjene na temelju individualne potrebe bolesnika.
English: Do not take INVEGA - if you are allergic to paliperidone, risperidone, or any of the other ingredients of this medicine
Croatian: Nemojte uzimati INVEGU - ako ste alergični na paliperidon, risperidon ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: • oversensitivity of the eyes to light, eye infection or "pink eye", dry eye
Croatian: • preosjetljivost očiju na svjetlost, infekcija oka ili „crveno oko”, suho oko
English: During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken INVEGA.
Croatian: Tijekom operacije katarakte, može doći do stanja oka nazvanog intraoperacijski sindrom meke šarenice (IFIS) ukoliko uzimate ili ste uzimali INVEGU.
English: A 15 mg dose was also included in Study R076477-SCH-305, but results are not presented since this is above the maximum recommended daily dose of 12 mg.
Croatian: U ispitivanje R076477SCH-305 je bila uključena i doza od 15 mg, no rezultati nisu prikazani budući je ta doza iznad maksimalne preporučene dnevne doze od 12 mg.
English: Potential for gastrointestinal obstruction
Croatian: Mogućnost gastrointestinalne opstrukcije
English: Paliperidone did not impair the neurobehavioural development in males at doses up to 2.5 mg/kg/day.
Croatian: Paliperidon nije oštetio neurobihevioralni razvoj u mužjaka pri dozama do 2,5 mg/kg/dan.
English: Schizophrenia (adults)
Croatian: Shizofrenija (odrasli)
English: The sedative effect of INVEGA should be closely monitored in this population.
Croatian: Sedativno djelovanje lijeka INVEGA potrebno je pažljivo nadzirati u ovoj populaciji.
English: Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in patients treated with medicines with alpha 1a-adrenergic antagonist effect, such as INVEGA (see section 4.8).
Croatian: Intraoperative floppy iris syndrome), primijećen je tijekom operacije katarakte u bolesnika liječenih lijekovima koji imaju učinak alfa 1a adrenergičkih antagonista, poput lijeka INVEGA (vidjeti dio 4.8).
English: The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
Croatian: Ovojnica tablete zajedno s netopivim sastojcima jezgre, eliminira se iz organizma; bolesnici se ne bi trebali zabrinuti ukoliko s vremena na vrijeme u stolici uoče nešto nalik na tabletu.
English: In addition, the difference in the percentage of patients demonstrating ≥ 20% improvement in PANSS total score at week 26 between the two treatment groups was numerically similar.
Croatian: Dodatno, razlika postotka bolesnika koji su pokazali poboljšanja ukupnog PANSS zbroja ≥ 20% u 26. tjednu za dvije liječene skupine bila je slična.
English: Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
Croatian: Zbog različitih farmakodinamičkih i farmakokinetičkih profila između antipsihotičkih lijekova, potreban je nadzor liječnika specijalista kad se prelazi na drugi antipsihotički lijek, koji se smatra medicinski opravdanim.
English: Patients with kidney problems Your doctor may adjust your dose of this medicine based upon your kidney function.
Croatian: Bolesnici s bubrežnim problemima Liječnik Vam može prilagoditi dozu ovog lijeka na temelju funkcije bubrega.
English: Since this medicine works primarily in the brain, interference from other medicines (or alcohol) that work in the brain could occur due to additive effect on brain function.
Croatian: Budući da ovaj lijek primarno djeluje na mozak, može doći do međusobnog djelovanja s drugim lijekovima (ili alkoholom) koji djeluju na mozak, te do njihovog zbirnog učinka na rad mozga.
English: Adolescents generally experienced side effects that were similar to those seen in adults except the following side effects were seen more commonly:
Croatian: Adolescenti su općenito doživjeli nuspojave slične onima koje su zabilježene u odraslih osim sljedećih nuspojava koje su zabilježene češće:
English: No interaction study between INVEGA and lithium has been performed, however, a pharmacokinetic interaction is unlikely to occur.
Croatian: Nisu provedena ispitivanja interakcija između lijeka INVEGA i litija, međutim, farmakokinetička interakcija nije vjerojatna.
English: It binds primarily to α1-acid glycoprotein and albumin.
Croatian: Pretežno se veže na α1-kiseli glikoprotein i albumin.
English: • elated mood (mania), irritability, depression, anxiety
Croatian: • ushićeno raspoloženje (manija), razdražljivost, depresija, tjeskoba
English: INVEGA should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Croatian: INVEGA se mora koristiti uz oprez s lijekovima koji povećavaju aktivnost središnjeg živčanog sustava (psihostimulansi, primjerice metilfenidat).
English: Paliperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8).
Croatian: Paliperidon može imati slab ili umjeren utjecaj na sposobnost upravljanja vozilima i rada sa strojevima zbog mogućih učinaka na živčani sustav i vid (vidjeti dio 4.8).
English: - if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia).
Croatian: - ako ste ikad imali nevoljne/nekontrolirane pokrete jezika ili lica (tardivna diskinezija).
English: • difficulty falling or staying asleep
Croatian: • poteškoće s uspavljivanjem ili ostankom u snu
English: • weight gain, increased appetite, weight loss, decreased appetite
Croatian: • porast težine, pojačan apetit, gubitak težine, smanjen apetit
English: Hypersensitivity to the active substance, risperidone, or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, risperidon ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Response defined as decrease from baseline in PANSS Total Score ≥ 20% Note: Negative change in score indicates improvement.
Croatian: Odgovor je definiran kao smanjenje u odnosu na početnu vrijednost u PANSS ukupnom rezultatu ≥ 20% Napomena: Negativna promjena rezultata ukazuje na poboljšanje.
English: The primary efficacy endpoint was defined as a decrease in total Positive and Negative Syndrome Scale (PANSS) scores as shown in the following table.
Croatian: Primarna mjera ishoda djelotvornosti bila je definirana kao smanjenje rezultata na ljestvici pozitivnih i negativnih simptoma (Positive and Negative Syndrome Scale PANSS) kao što je prikazano u sljedećoj tablici.
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 je intravenska nadoknada tekućine i/ili simpatomimetici.
English: Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias.
Croatian: Potrebno je odmah započeti s nadzorom kardiovaskularnih funkcija koji treba obuhvatiti i kontinuirano elektrokardiografsko praćenje zbog mogućih aritmija.
English: If you miss one dose, take your next dose on the day following the missed dose.
Croatian: Ako propustite jednu dozu, uzmite sljedeću u uobičajeno vrijeme.
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 tradicionalnih neuroleptika.
English: Keep the bottle tightly closed in order to protect from moisture.
Croatian: Bocu držite čvrsto zatvorenu radi zaštite od vlage.
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 to a lesser extent than traditional neuroleptics.
Croatian: Iako je paliperidon snažan D2-antagonist za koji se smatra da ublažava pozitivne simptome shizofrenije, on manje izaziva katalepsiju i manje utječe na smanjenje motoričke funkcije u odnosu na klasične neuroleptike.
English: There is no relevant use of INVEGA in children aged less than 12 years.
Croatian: Nema relevantne primjene lijeka INVEGA u djece mlađe od 12 godina.