FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use physostigmine in case of dysrhythmias, any degree of heart block or QRS-widening.
Croatian: Fizostigmin se ne smije primjenjivati u slučaju disritmija, bilo kojeg stupnja srčanog bloka ili proširenja QRS intervala.
English: May occur at or near initiation of treatment and be associated with hypotension and/or syncope.
Croatian: Može se javiti na početku ili ubrzo nakon početka liječenja i biti praćena hipotenzijom i/ili sinkopom.
English: Patients experiencing somnolence of severe intensity may require more frequent contact for a minimum of 2 weeks from onset of somnolence, or until symptoms improve and treatment discontinuation may need to be considered.
Croatian: Bolesnicima koji osjete somnolenciju jačeg intenziteta može biti potreban češći nadzor tijekom minimalno 2 tjedna od nastupa somnolencije ili dok se simptomi ne poboljšaju.
English: These data do not establish a causal relationship between quetiapine treatment and death in elderly patients with dementia.
Croatian: Ovi podaci nisu ustanovili uzročno-posljedičnu vezu između liječenja kvetiapinom i smrti kod starijih bolesnika s demencijom.
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Croatian: Prijavljeni su agitacija, hipertonija, hipotonija, tremor, somnolencija, respiratorni distres, ili poremećaj hranjenja.
English: It is recommended that Seroquel XR is taken once daily without food.
Croatian: Seroquel XR uzimati jednom dnevno bez hrane.
English: Longer term relapse prevention trials had an open label period (ranging from 4 to 36 weeks) during which patients were treated with quetiapine, followed by a randomized withdrawal period during which patients were randomized to quetiapine or placebo.
Croatian: Dugoročnija ispitivanja za prevenciju relapsa imala su i razdoblje otvorenog tipa (u rasponu od 4 do 36 tjedana) tijekom kojeg su bolesnici liječeni kvetiapinom, nakon čega je slijedilo razdoblje randomiziranog povlačenja u kojem su ispitanici randomizirani u skupine s kvetiapinom ili placebom.
English: Neutropenia should be considered in patients presenting with infection or fever, particularly in the absence of obvious predisposing factor(s), and should be managed as clinically appropriate.
Croatian: Na neutropeniju je potrebno posumnjati u bolesnika koji imaju infekciju ili vrućicu, osobito u odsutnosti očitih predisponirajućih faktora, te ju je potrebno liječiti kako je klinički prikladno.
English: • Thioridazine or Lithium (other anti-psychotic medicines).
Croatian: • tioridazin ili litij (također antipsihotici),
English: Overdose could lead to QT-prolongation, seizures, status epilepticus, rhabdomyolysis, respiratory depression, urinary retention, confusion, delirium and/or agitation, coma and death.
Croatian: Predoziranje može dovesti do produljenja QT-intervala, napadaja, stanja status epilepticus, rabdomiolize, respiratorne depresije, retencije urina, konfuzije, delirija, i/ili agitacije, kome i smrti.
English: It is this combination of receptor antagonism with a higher selectivity for 5HT2 relative to D2- receptors, which is believed to contribute to the clinical antipsychotic properties and low extrapyramidal side effect (EPS) liability of Seroquel compared to typical antispychotics.
Croatian: Upravo ta kombinacija antagonizma između receptora, s većom selektivnosti prema 5HT2 naspram D2 receptora, vjeruje se, pridonosi kliničkim antipsihotičnim svojstvima i slabijim ekstrapiramidnim nuspojavama (EPS) Seroquela u usporedbi s tipičnim antipsihoticima.
English: Long-term implications for cognitive and behavioural development are not known.
Croatian: Učinak dugotrajnog liječenja na kognitivni i bihevioralni razvoj nije poznat.
English: Do not take Seroquel if you are taking any of the following medicines:
Croatian: Nemojte uzimati Seroquel ukoliko uzimate bilo koji od sljedećih lijekova:
English: Patients should be observed for signs and symptoms of infection and neutrophil counts followed (until they exceed 1.5 X 109/L) (see section 5.1).
Croatian: Bolesnike se mora promatrati kako bi se uočili znakovi i simptomi infekcije, te kontrolirati broj neutrofila (dok ne premaše broj od 1,5 X 109/L) (vidjeti dio 5.1).
English: In general, reported signs and symptoms were those resulting from an exaggeration of the active substance's known pharmacological effects, ie, drowsiness and sedation, tachycardia and hypotension.
Croatian: Općenito, prijavljeni znaci i simptomi su bili rezultat prenaglašenih poznatih farmakoloških učinaka djelatne tvari, tj. omamljenost i sedacija, tahikardija i hipotenzija.
English: The elimination half lives of quetiapine and norquetiapine are approximately 7 and 12 hours, respectively.
Croatian: Poluvrijeme eliminacije kvetiapina i norkvetiapina su približno 7 odnosno 12 sati.
English: These thoughts may also be increased if you suddenly stop taking your medication.
Croatian: Ove misli mogu biti češće i pri naglom prestanku uzimanja lijeka.
English: In a fertility study in rats, marginal reduction in male fertility and pseudopregnancy, protracted periods of diestrus, increased precoital interval and reduced pregnancy rate were seen.
Croatian: U ispitivanju plodnosti kod štakora, uočeni su marginalno smanjenje muške plodnosti i lažna trudnoća, produljeno razdoblje diestrusa, produljeni prekoitalni interval i smanjena stopa trudnoća.
English: The effect size of the 600 mg and 800 mg doses was greater than that of the 400 mg dose.
Croatian: Učinak s primijenjenim dozama od 600 i 800 mg lijeka, bio je veći nego kod primjene doze od 400 mg.
English: Quetiapine and the active human plasma metabolite, norquetiapine interact with a broad range of neurotransmitter receptors.
Croatian: Kvetiapin i aktivni metabolit u ljudskoj plazmi, norkvetiapin, djeluju na široki raspon neurotransmiterskih receptora.
English: Hypersensitivity to the active substance or to any of the excipients of this product.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari ovog lijeka.
English: The incidences of shifts in TSH was 3.2 % for quetiapine versus 2.7 % for placebo.
Croatian: Incidencije pomaka u TSH su bile 3,2% za kvetiapin te 2,7% za placebo.
English: Given its primary central nervous system effects, quetiapine may interfere with activities requiring mental alertness.
Croatian: Obzirom na primarni učinak kvetiapina na središnji živčani sustav, kvetiapin može ometati aktivnosti koje zahtijevaju mentalnu pozornost.
English: The effects of quetiapine on human fertility have not been assessed.
Croatian: Učinci kvetiapina na plodnost ljudi nisu ocijenjeni.
English: Caution should be exercised when quetiapine is used concomitantly with medicinal products known to cause electrolyte imbalance or to increase QT interval.
Croatian: Oprez je nužan kada se kvetiapin primjenjuje istodobno s lijekovima za koje je poznato da uzrokuju neravnotežu elektrolita ili produljenje QT intervala.
English: The number of patients with a mood event was 91 (22.5%) in the quetiapine group, 208 (51.5%) in the placebo group and 95 (26.1%) in the lithium treatment groups respectively.
Croatian: Broj bolesnika s epizodom poremećaja raspoloženja iznosio je 91 (22,5%) u kvetiapin skupini, 208 (51,5%) u placebo skupini i 95 (26,1%) u skupini koja je liječena litijem.
English: Close medical supervision and monitoring should be continued until the patient recovers.
Croatian: Bolesnika se mora pažljivo i stalno nadzirati do njegova oporavka.
English: The mean clearance of quetiapine in the elderly is approximately 30 to 50% lower than that seen in adults aged 18 to 65 years.
Croatian: Srednja vrijednost klirensa kvetiapina u starijih je osoba oko 30 do 50% manja negoli u odraslih osoba u dobi 18 do 65 godina.
English: • Medicines that can cause constipation.
Croatian: • lijekove koji mogu uzrokovati zatvor (konstipaciju)
English: Pharmacodynamic effects:
Croatian: Farmakodinamički učinci:
English: In pre-clinical tests predictive of EPS, quetiapine is unlike typical antipsychotics and has an atypical profile.
Croatian: U nekliničkim ispitivanjima prediktivnim za ekstrapiramidne simptome (EPS), kvetiapin za razliku od tipičnih antipsihotika ima atipični profil.
English: Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatine phosphokinase.
Croatian: Klinički znaci obuhvaćaju: hipertermiju, promijenjen mentalni status, ukočenost mišića, nestabilnost autonomnog sustava i povišenu kreatin-fosfokinazu.
English: Pharmacotherapeutic group: Antipsychotics; Diazepines, oxazepines and thiazepines ATC code: N05A H04
Croatian: Farmakoterapijska skupina: Antipsihotici; diazepini, oksazepini i tiazepini ATK oznaka: N05A H04
English: No information is available for Seroquel XR in children and adolescents.
Croatian: Nisu dostupni podaci za Seroquel XR u djece i adolescenata.
English: What you need to know before you take Seroquel
Croatian: Što morate znati prije nego počnete uzimati Seroquel
English: Tachycardia Palpitations23
Croatian: Srčani poremećaji tahikardija palpitacije23
English: For preventing recurrence in bipolar disorder
Croatian: Za sprječavanje ponovne pojave epizoda bolesti u bipolarnom poremećaju
English: In individual patients, in the event of tolerance concerns, clinical trials have indicated that dose reduction to a minimum of 200 mg could be considered.
Croatian: Klinička ispitivanja su ukazala da se kod pojedinih bolesnika, u slučaju zabrinutosti oko podnošljivosti lijeka, može razmotriti smanjenje doze na minimum od 200 mg.
English: The long-term efficacy of Seroquel IR in prevention of schizophrenic relapses has not been verified in blinded clinical trials.
Croatian: Dugotrajna djelotvornost Seroquel tablete s trenutnim oslobađanjem u prevenciji relapsa shizofrenije nije bila potvrđena u slijepim kliničkim ispitivanjima.
English: • Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
Croatian: • alergijske reakcije koje mogu uključiti pojavu odignutih kvržica (koprivnjača) na koži, oticanje kože i oticanje područja oko usta
English: The lowest effective dose, starting from 50 mg/day should be used.
Croatian: Mora se koristiti najniža učinkovita doza, počevši od 50 mg/dan.
English: In vitro CYP inhibition is observed only at concentrations approximately 5 to 50 fold higher than those observed at a dose range of 300 to 800 mg/day in humans.
Croatian: Inhibicija CYP-a in vitro zabilježena je samo kod koncentracija oko 5 do 50 puta većih od onih zabilježenih u rasponu doza od 300 do 800 mg dnevno u ljudi.
English: In addition, a higher percentage of patients treated in the lithium add-on group (8.0%) had weight gain (≥7%) at the end of treatment compared to patients in the placebo add-on group (4.7%).
Croatian: Osim toga, veći postotak bolesnika u skupini kojoj je dodavan litij (8,0%) imao je povećanje tjelesne težine (≥ 7%) na kraju liječenja u usporedbi s bolesnicima u skupini kojoj je dodavan placebo (4,7%).
English: Clinical efficacy:
Croatian: Klinička djelotvornost:
English: Quetiapine and norquetiapine have no appreciable affinity at benzodiazepine receptors but high affinity at histaminergic and adrenergic alpha1 receptors, moderate affinity at adrenergic alpha2 receptors and moderate to high affinity at several muscarinic receptors.
Croatian: Kvetiapin i norkvetiapin nemaju značajnijeg afiniteta za receptore benzodiazepina, ali pokazuju visok afinitet za histaminergičke i adrenergičke α1-receptore, umjeren afinitet za adrenergičke α2-receptore te umjeren do visok afinitet za nekoliko muskarinskih receptora.
English: Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression.
Croatian: Podaci iz kliničkih ispitivanja su pokazali povećani rizik od pojave misli o samoubojstvu i/ili suicidalnog ponašanja u odraslih osoba mlađih od 25 godina, koje boluju od depresije.
English: This may make you feel dizzy or faint (may lead to falls).
Croatian: Ovo može biti razlogom da osjećate omaglicu ili nesvjesticu (može dovesti do padova)
English: Patients should be advised to immediately report the appearance of signs/symptoms consistent with agranulocytosis or infection (e.g., fever, weakness, lethargy, or sore throat) at any time during Seroquel therapy.
Croatian: Bolesnicima treba savjetovati da odmah prijave pojavu znakova/simptoma koji odgovaraju agranulocitozi ili infekciji (npr. vrućicu, slabost, letargiju ili grlobolju) u bilo kojem trenutku tijekom terapije
English: Seroquel XR can be used to treat several illnesses, such as:
Croatian: Seroquel XR se može koristiti u liječenju različitih bolesti kao što su:
English: Neonates exposed to antipsychotics (including quetiapine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Croatian: Kod novorođenčadi izložene antipsihoticima (uključujući i kvetiapin) tijekom trećeg trimestra trudnoće postoji rizik od nuspojava uključujući ekstrapiramidne i/ili simptome ustezanja koji mogu varirati u težini i trajanju nakon poroda.
English: As Seroquel has several indications, the safety profile should be considered with respect to the individual patient's diagnosis and the dose being administered.
Croatian: Budući da Seroquel ima nekoliko indikacija, sigurnosni profil lijeka potrebno je razmotriti uzimajući u obzir dijagnozu pojedinog bolesnika i dozu koja se primjenjuje.
English: Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.
Croatian: Bolesnici, naročito oni izloženi visokom riziku moraju se uz terapiju lijekovima pomno nadzirati, naročito u ranom liječenju i nakon promjena doze.
English: An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled trials in the dementia population with some atypical antipsychotics.
Croatian: Približno trostruko povećanje rizika od nastanka cerebrovaskularnih štetnih događaja zabilježeno je u placebom kontroliranim randomiziranim ispitivanjima u populaciji oboljeloj od demencije, uz neke atipične antipsihotike.
English: Increased appetite, blood glucose increased to hyperglycaemic levels 6, 30
Croatian: pojačan apetit, povećanje razine glukoze u krvi do hiperglikemijs kih razina6, 30
English: Therefore, patients should be advised not to drive or operate machinery, until individual susceptibility to this is known.
Croatian: Stoga se bolesnicima ne savjetuje upravljanje vozilima ili rad sa strojevima, prije nego što se ustanovi individualna podložnost lijeku.
English: Shifts in eosinophils are defined as >1x 10^9 cells/L at any time.
Croatian: Pomaci u eozinofilima su definirani kao >1 x 10^9 stanica/L u bilo kojem trenutku.
English: Based on these in vitro results, it is unlikely that co-administration of quetiapine with other drugs will result in clinically significant drug inhibition of cytochrome P450 mediated metabolism of the other drug.
Croatian: Na osnovu ovih in vitro rezultata, nije vjerojatno da će istodobna primjena kvetiapina s drugim lijekovima izazvati klinički značajnu inhibiciju citokrom P450 posredovanog metabolizma tog drugog lijeka.
English: As a consequence of this interaction, lower plasma concentrations can occur, which could affect the efficacy of quetiapine therapy.
Croatian: Kao posljedica te interakcije, može doći do smanjenja koncentracije kvetiapina u plazmi, što može utjecati na djelotvornost liječenja kvetiapinom.
English: This is further supported by the data from a positron emission tomography (PET) study, which identified that for quetiapine, 5HT2- and D2-receptor occupancy are maintained for up to 12 hours.
Croatian: Ovo potvrđuju rezultati ispitivanja u kojima je korištena pozitronska emisijska tomografija (PET), koji su pokazali da kvetiapin ostaje vezan za 5HT2- i D2-receptore do 12 sati.
English: For the treatment of schizophrenia, Seroquel should be administered twice a day.
Croatian: Za liječenje shizofrenije Seroquel je potrebno uzimati dva puta dnevno.
English: Quetiapine treatment has been associated with orthostatic hypotension and related dizziness (see Section 4.8) which, like somnolence has onset usually during the initial dose-titration period.
Croatian: Liječenje kvetiapinom je povezano s ortostatskom hipotenzijom i, posljedično, omaglicom (vidjeti dio 4.8) koja se, poput somnolencije, obično pojavljuje tijekom početnog razdoblja titracije doze.
English: Effects related to elevated prolactin levels were seen in rats, although these are not directly relevant to humans (see section 5.3 preclinical data).
Croatian: U štakora su primijećeni učinci povezani s povećanim razinama prolaktina, ali oni nemaju izravnog značaja za ljude (vidjeti dio 5.3 Neklinički podaci o sigurnosti primjene).
English: Changes in thyroid function tests have also been observed in children and adolescents.
Croatian: Primijećene su i promjene u vrijednostima dobivenim testovima funkcije štitne žlijezde u djece i adolescenata.
English: • Symptoms of withdrawal may occur in newborn babies of mothers that have used Seroquel during their pregnancy.
Croatian: • simptomi ustezanja (prekida primjene lijeka) mogu nastupiti u novorođenčadi čije su majke uzimale Seroquel tijekom trudnoće
English: Concomitant use of quetiapine with a strong hepatic enzyme inducer such as carbamazepine or phenytoin substantially decreases quetiapine plasma concentrations, which could affect the efficacy of quetiapine therapy.
Croatian: Istodobna primjena kvetiapina sa snažnim induktorima jetrenih enzima, kao što su karbamazepin ili fenitoin, znatno smanjuje koncentraciju kvetiapina u plazmi, što može utjecati na djelotvornost liječenja kvetiapinom.
English: (20) Cases of suicidal ideation and suicidal behaviours have been reported during quetiapine therapy or early after treatment discontinuation (see Sections 4.4 and 5.1).
Croatian: 20. Slučajevi suicidalnih misli i suicidalnog ponašanja su prijavljeni za vrijeme terapije kvetiapinom ili ubrzo nakon prestanka liječenja (vidjeti dijelove 4.4 i 5.1).
English: The use of quetiapine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Croatian: Upotreba kvetiapina povezuje se s razvojem akatizije, koju karakterizira nemir uz subjektivni osjećaj neugode ili uznemirenosti i potreba za kretanjem koje često prati nemogućnost mirnog sjedenja ili stajanja.
English: Liver problems If you have liver problems your doctor may change your dose.
Croatian: Ukoliko imate jetrenih tegoba liječnik Vam može promijeniti dozu lijeka.
English: • Erythromycin or clarithromycin (for infections).
Croatian: • eritromicin ili klaritromicin (za suzbijanje infekcija),
English: 240 tablets
Croatian: 240 tableta
English: vs. 0% in the bipolar depression trial.
Croatian: 1,1% naspram 0% u ispitivanju u bipolarnoj depresiji.
English: Based on shifts above clinically significant thresholds (adapted from the National Institutes of Health criteria) or increases >20 mmHg for systolic or >10 mmHg for diastolic blood pressure at any time in two acute (3-6 weeks) placebo-controlled trials in children and adolescents.
Croatian: Temeljeno na pomacima iznad klinički značajnog praga (preuzeto iz „National Institutes of Health criteria“) ili povećanju od > 20 mmHg za sistolički ili > 10 mmHg za dijastolički krvni tlak u bilo koje vrijeme u dva akutna (3-6 tjedana) placebom kontrolirana klinička ispitivanja u djece i adolescenata.
English: • Feeling weak.
Croatian: • osjećaj slabosti
English: In both bipolar depression and MDD, the incidence of the individual adverse events (eg, akathisia, extrapyramidal disorder, tremor, dyskinesia, dystonia, restlessness, muscle contractions involuntary, psychomotor hyperactivity and muscle rigidity) did not exceed 4% in any treatment group.
Croatian: I u bipolarnoj depresiji i velikom depresivnom poremećaju incidencija pojedinih štetnih događaja (npr. akatizija, ekstrapiramidni poremećaj, tremor, diskinezija, distonija, nemir, nevoljne mišićne kontrakcije, psihomotorna hiperaktivnost i mišićna rigidnost) nisu prelazile 4% niti u jednoj terapijskoj skupini.
English: The same side effects that may occur in adults may also occur in children and adolescents.
Croatian: Iste nuspojave koje se mogu pojaviti u odraslih mogu se također pojaviti u djece i adolescenata.
English: 6.5 Nature and contents of container PVC/aluminium blisters Pack sizes
Croatian: 6.5 Vrsta i sadržaj spremnika PVC/aluminij blisteri.
English: In cases of quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents.
Croatian: U slučaju predoziranja kvetiapinom, refraktornu hipotenziju potrebno je liječiti prikladnim mjerama, kao što su davanje tekućine intravenski i/ili simpatomimetika.
English: It is important that any change in the inducer is gradual, and if required, replaced with a non-inducer (e.g. sodium valproate).
Croatian: Važno je da se bilo kakva promjena u doziranju induktora provodi postupno, te ako je neophodno, zamjeni s ne-induktorom (npr. natrijev valproat).
English: For 150 mg and 300 mg tablets pack sizes of 120, 180 and 240 tablets are registered.
Croatian: Za tablete od 150 mg i 300 mg registrirane su veličine pakiranja od 120, 180 i 240 tableta.
English: • Serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
Croatian: • ozbiljna, iznenadna alergijska reakcija sa simptomima kao što su vrućica, mjehuri na koži i ljuštenje kože (toksična epidermalna nekroliza)
English: • A condition (called “metabolic syndrome”) where you may have a combination of 3 or more of the following: an increase in fat around your abdomen, a decrease in “good cholesterol” (HDL-C), an increase in a type of fat in your blood called triglycerides, high blood pressure and an increase in your blood sugar.
Croatian: • stanje koje se naziva „metaboličkim sindromom“, kod kojega možete imati kombinaciju 3 ili više od sljedećih faktora: povećanje masnog tkiva oko trbuha, smanjenje razine „dobrog“ (HDL) kolesterola, povišenje razine jedne vrste masnoća u krvi (triglicerida), visok krvni tlak i povišenje razine šećera u krvi.
English: • Feeling irritated
Croatian: • osjećaj razdražljivosti
English: Gradual withdrawal over a period of at least 1 to 2 weeks is advisable.
Croatian: Preporuča se postupno prekidanje uzimanja lijeka u periodu od najmanje 1 do 2 tjedna.
English: • Fainting (may lead to falls)
Croatian: • nesvjestica (može dovesti do padova)
English: Quetiapine does not produce dopamine D2-receptor supersensitivity after chronic administration.
Croatian: Kvetiapin ne dovodi do preosjetljivosti dopaminskih D2 receptora nakon kronične primjene.
English: Do not take Seroquel XR:
Croatian: Nemojte uzimati Seroquel XR :
English: Gender The kinetics of quetiapine do not differ between men and women.
Croatian: Spol Kinetika kvetiapina se ne razlikuje kod muškaraca i žena.
English: Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
Croatian: Hiperglikemija i/ili razvoj ili egzacerbacija dijabetesa povremeno praćena ketoacidozom ili komom su rijetko prijavljivani, uključujući i neke fatalne slučajeve (vidjeti dio 4.8).
English: Like all medicines, Seroquel XR can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, Seroquel XR može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Reporting of suspected adverse reactions:
Croatian: Reakcije ustezanja: