FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Croatian: • Čak i ako se osjećate bolje, tablete nemojte prestati uzimati sve dok Vam to ne preporuči liječnik.
English: These effects are related to elevated prolactin levels and not directly relevant to humans because of species differences in hormonal control of reproduction.
Croatian: Ovi učinci su povezani s povišenim razinama prolaktina i nisu direktno važni za ljude zbog razlika među vrstama u hormonalnoj kontroli reprodukcije.
English: • Body temperature decreased (hypothermia).
Croatian: • snižena temperatura tijela (hipotermija)
English: Hypersensitivity (including allergic skin reactions)
Croatian: (uključujući alergijske kožne reakcije)
English: Elderly people If you are elderly your doctor may change your dose.
Croatian: Ukoliko ste u starijoj životnoj dobi liječnik Vam može promijeniti dozu lijeka.
English: 12-October-2009
Croatian: 12. listopada 2009.
English: The incidence of reciprocal, potentially clinically significant shifts of both T3 or T4 and TSH in these trials were rare, and the observed changes in thyroid hormone levels were not associated with clinically symptomatic hypothyroidism.
Croatian: Incidencija recipročnih, potencijalno klinički značajnih pomaka za T3 ili T4 i TSH u ovim ispitivanjima je bila rijetka, i zapažene promjene u razinama hormona štitnjače nisu bile povezane s klinički simptomatskim hipotireoidizmom.
English: For about 2/3 of all cases, cessation of quetiapine treatment was associated with a reversal of the effects on total and free T4, irrespective of the duration of treatment.
Croatian: U oko 2/3 slučajeva, prestanak liječenja kvetiapinom je bio povezan sa obratom učinka na ukupni i slobodni T4, bez obzira na duljinu liječenja.
English: The safety and efficacy of doses greater than 800 mg/day have not been evaluated.
Croatian: Sigurnost i djelotvornost doza većih od 800 mg dnevno nisu ispitani.
English: Therefore, quetiapine should only be used during pregnancy if the benefits justify the potential risks.
Croatian: Stoga se kvetiapin u trudnoći smije primjenjivati samo ako koristi liječenja opravdavaju moguće rizike.
English: Mean change among patients who had this increase was 41.7 mg/dL (≥1.07 mmol/L).
Croatian: Srednja vrijednost promjene među bolesnicima koji su imali ovo povećanje je bila 41,7 mg/dL (≥ 1,07 mmol/L).
English: • Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad.
Croatian: • Bipolarna depresija i velike depresivne epizode u velikom depresivnom poremećaju: stanje u kojem ste tužni.
English: Less than 1% of patients had an increase to a prolactin level >100 ug/L.
Croatian: Manje od 1% bolesnika je imalo povećanje razine prolaktina > 100 µg/L.
English: For 3Day Starterpack pack size of 8 tablets is registered and for 4-Day Starterpack pack size of 10 tablets is registered.
Croatian: Za 3-dnevno početno pakiranje registirana je veličina pakiranja od 8 tableta, a za 4-dnevno početno pakiranje registirana je veličina pakiranja od 10 tableta.
English: Your doctor may suggest you reduce the dose gradually before stopping treatment.
Croatian: Liječnik Vam može savjetovati da postupno smanjujete dozu lijeka, sve do potpunog prestanka njegova uzimanja.
English: The incidences of ADRs associated with quetiapine therapy, are tabulated below (Table 1) according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group; 1995).
Croatian: Incidencija nuspojava, povezanih s liječenjem kvetiapinom, navedena je u sljedećoj tablici (Tablica 1) u obliku koji je preporučila radna skupina Council for International Organizations of Medical Sciences (CIOMS III Working Group) godine 1995.
English: For these patients, the mean maximum decrease in hemoglobin at any time was -1.50 g/dL.
Croatian: Kod ovih bolesnika, srednja vrijednost maksimalnog smanjenja hemoglobina u bilo kojem trenutku je bila -1.50 g/dL.
English: The maintenance dose (daily dose) will depend on your illness and needs but will usually be between 150 mg and 800 mg.
Croatian: Doza održavanja (dnevna doza) će ovisiti o Vašoj bolesti i potrebama, no obično će se kretati između 150 mg i 800 mg.
English: The reduction in total and free T4 was maximal within the first six weeks of quetiapine treatment, with no further reduction during long-term treatment.
Croatian: Smanjenje ukupnog i slobodnog T4 je bilo maksimalno unutar prvih šest tjedana liječenja kvetiapinom, bez daljnjeg smanjenja tijekom dugoročnog liječenja.
English: Doses greater than 300 mg should be initiated by physicians experienced in treating bipolar disorder.
Croatian: Doze veće od 300 mg mora započeti liječnik s iskustvom u liječenju bipolarnih poremećaja.
English: In comparison, a light meal had no significant effect on the Cmax or AUC of quetiapine.
Croatian: Usporedbe radi, lagani obrok nema značajnog učinka na Cmax, odnosno AUC kvetiapina.
English: • You can take your tablets with or without food.
Croatian: • Tablete možete uzimati uz obrok ili bez obroka.
English: Do not take Seroquel :
Croatian: Nemojte uzimati Seroquel:
English: An increase in LDL cholesterol of ≥30 mg/dL (≥0.769 mmol/L) has been very commonly observed.
Croatian: Povećanje LDL kolesterola od ≥ 30 mg/dL (≥ 0,769 mmol/L) bilo je vrlo često zabilježeno.
English: Patients with a history of suicide related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Croatian: Poznato je da su bolesnici s anamnezom događaja povezanih sa suicidom, ili oni koji prije početka liječenja pokazuju značajni stupanj suicidalnih misli izloženi većem riziku od suicidalnih misli ili pokušaja suicida te ih se mora pomno nadzirati tijekom liječenja.
English: Mechanism of action:
Croatian: Mehanizam djelovanja:
English: The need to increase the dose from 150 to 300 mg/day should be based on individual patient evaluation.
Croatian: Potreba za povećanjem doze sa 150 na 300 mg/dan treba se temeljiti prema procjeni pojedinog bolesnika.
English: Seroquel can be used to treat several illnesses, such as:
Croatian: Seroquel se može koristiti u liječenju različitih bolesti kao što su:
English: Always take Seroquel XR exactly as your doctor has told you.
Croatian: Uvijek uzmite Seroquel XR točno onako kako Vam je rekao Vaš liječnik.
English: Clinical trials have demonstrated that Seroquel is effective in schizophrenia and mania when given twice a day, although quetiapine has a pharmacokinetic half-life of approximately 7 hours.
Croatian: Klinička ispitivanja su pokazala da je Seroquel učinkovit u liječenju shizofrenije i manije kada se uzima dva puta dnevno, iako je farmakokinetičko poluvrijeme kvetiapina oko 7 sati.
English: • Severe rash, blisters, or red patches on the skin.
Croatian: • težak osip, mjehuri ili crvene mrlje na koži
English: Patients with intestinal obstruction/ileus should be managed with close monitoring and urgent care.
Croatian: Bolesnike s opstrukcijom crijeva/ileusom treba zbrinjavati pomnim nadziranjem i hitnim liječenjem.
English: • Unpleasant sensations in the legs (also called restless legs syndrome).
Croatian: • neugodan osjećaj u nogama (nazvan još i sindromom nemirnih nogu)
English: Prior to initiating treatment, clinicians should consider the safety profile of SEROQUEL XR (see Section
Croatian: Prije početka liječenja, kliničari moraju uzeti u obzir sigurnosni profil lijeka SEROQUEL XR (vidjeti dio 4.4)
English: Patients with preexisting severe cardiovascular disease may be at an increased risk of the effects of overdose.
Croatian: Bolesnici s postojećom teškom kardiovaskularnom bolesti mogu biti pod povećanim rizikom od učinaka predoziranja
English: Based on individual patient evaluation, if dose increase to 300 mg/day is required this should not be prior to Day 22 of treatment.
Croatian: S obzirom na procjenu pojedinog bolesnika, ukoliko je potrebno povećanje doze na 300 mg/dan, to se ne smije učiniti prije 22. dana liječenja.
English: No data are available on maintenance of effect or recurrence prevention in this age group.
Croatian: Nisu dostupni podaci o održanju učinka ili sprječavanju ponovnih pojava epizoda u ovoj dobnoj skupini.
English: Confirmation of questionable immunoassay screening results by an appropriate chromatographic technique is recommended.
Croatian: Preporučuje se potvrda upitnih rezultata probirnih imunotestova prikladnom kromatografskom tehnikom.
English: From Day 4 onwards, the dose should be titrated to the usual effective dose of 300 to 450 mg/day.
Croatian: Od četvrtoga dana nadalje, dozu je potrebno titrirati do uobičajene učinkovite doze od 300 do 450 mg dnevno.
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Croatian: Preporuča se odgovarajuće kliničko praćenje u skladu sa smjernicama za primjenu antipsihotika.
English: • Feeling more hungry
Croatian: • povećan osjećaj gladi
English: Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
Croatian: Daljnje prilagodbe doze do 800 mg dnevno do 6. dana potrebno je provesti uz povećanja ne veća od 200 mg dnevno.
English: • You, or someone in your family, have or have had any heart problems, for example heart rhythm problems, weakening of the heart muscle or inflammation of the heart or if you are taking any medicines that may have an impact on the way your heart beats.
Croatian: • ako Vi ili netko od članova Vaše obitelji, ima ili je imao bilo kakve srčane tegobe, primjerice poremećaje srčanog ritma, slabljenje srčanog mišića ili upalu srca, ili ako uzimate bilo kakve lijekove koji mogu utjecati na rad srca.
English: • Skin rash with irregular red spots (erythema multiforme)
Croatian: • kožni osip s nepravilnim crvenim mrljama (multiformni eritem)
English: Somnolence and dizziness:
Croatian: Somnolencija i omaglica:
English: A second study did not demonstrate an additive effect at week 6.
Croatian: Drugo ispitivanje nije pokazalo aditivni učinak u šestom tjednu.
English: Anaphylactic reaction5
Croatian: anafilaktička reakcija5
English: • Seroquel XR can be affected by food and you should therefore take your tablets at least one hour before a meal or prior to bedtime.
Croatian: • Hrana može utjecati na djelotvornost Seroquela XR, te stoga ovaj lijek morate uzimati najmanje jedan sat prije obroka ili prije spavanja.
English: Pharmacotherapeutic group: Antipsychotics ATC code: N05A H04
Croatian: Farmakoterapijska skupina: Antipsihotici ATK oznaka: N05A H04
English: Your doctor may continue to prescribe Seroquel even when you are feeling better.
Croatian: Liječnik Vam može nastaviti davati Seroquel, čak i kada se osjećate bolje.
English: • Medicines that have an impact on the way your heart beats, for example, drugs that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (water pills) or certain antibiotics (drugs to treat infections).
Croatian: • lijekove koji utječu na rad srca, npr. lijekovi koji mogu uzrokovati neravnotežu elektrolita (niske razine kalija ili magnezija) kao što su diuretici (lijekovi za izmokravanje) te određeni antibiotici
English: Most cases of severe neutropenia have occurred within a couple of months of starting therapy with quetiapine.
Croatian: U većini se slučajeva teška neutropenija javljala unutar nekoliko mjeseci od početka liječenja kvetiapinom.
English: Quetiapine and several of its metabolites (including norquetiapine) were found to be weak inhibitors of human cytochrome P450 1A2, 2C9, 2C19, 2D6 and 3A4 activities in vitro.
Croatian: Kvetiapin i nekoliko njegovih metabolita (uključujući norkvetiapin) pokazali su se kao slabi inhibitori humanog citokroma P450 1A2, 2C9, 2C19, 2D6 i 3A4 in vitro.
English: In addition, for 25 mg tablets pack size of 6 tablets is registered.
Croatian: Dodatno je za tablete od 25 mg registirana veličina pakiranja od 6 tableta.
English: You may find that you feel depressed, feel guilty, lack energy, lose your appetite or can't sleep.
Croatian: Isto tako, možete se osjećati potišteno, imati osjećaj krivnje, nedostatak energije, gubitak teka ili nesanicu.
English: Increases in the hormone prolactin could in rare cases lead to the following:
Croatian: Povećane količine hormona prolaktina mogu u rijetkim slučajevima uzrokovati sljedeće:
English: • You have diabetes or have a risk of getting diabetes.
Croatian: • ako bolujete od šećerne bolesti ili postoji rizik da od nje obolite.
English: Combined pack
Croatian: Kombinirano pakiranje
English: 25 mg tablets
Croatian: 25 mg tablete
English: Neuroleptic Malignant Syndrome:
Croatian: Neuroleptički maligni sindrom:
English: For maintenance therapy in schizophrenia no dosage adjustment is necessary.
Croatian: terapiji održavanja shizofrenije nije potrebna prilagodba doze.
English: Based on >7% increase in body weight from baseline.
Croatian: Temeljeno na > 7% povećanju tjelesne težine u odnosu na početnu vrijednost.
English: The recommended daily dose is 600 mg, however if clinically justified the dose may be increased to 800 mg daily.
Croatian: Preporučena dnevna doza je 600 mg, a ukoliko je to klinički opravdano može se povisiti do 800 mg dnevno.
English: • You have had a stroke, especially if you are elderly.
Croatian: • ako ste preboljeli moždani udar, posebice ukoliko ste u starijoj životnoj dobi.
English: Bipolar Disorder
Croatian: Bipolarni poremećaj
English: The data showed an additive effect at week 3.
Croatian: Podaci pokazuju aditivni učinak u trećem tjednu.
English: • Take your tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when.
Croatian: • Tablete uzimajte bez hrane (najmanje jedan sat prije obroka ili prije spavanja).
English: Effect on Urine Drug Screens
Croatian: Učinak na probirne testove na lijekove u urinu
English: • Yellowing of the skin and eyes (jaundice).
Croatian: • žutilo kože i očiju (žutica)
English: The following studies were conducted with Seroquel XR as monotherapy treatment, however Seroquel XR is only indicated for use as add-on therapy:
Croatian: Sljedeća ispitivanja provedena su sa Seroquelom XR kao monoterapijom, ali Seroquel XR je indiciran za uporabu samo kako dodatna terapija:
English: This includes fatal reports in patients who are at higher risk of intestinal obstruction, including those that are receiving multiple concomitant medications that decrease intestinal motility and/or may not report symptoms of constipation.
Croatian: To uključuje i prijave smrtnih slučajeva u bolesnika izloženih povećanom riziku za opstrukciju crijeva, uključujući one koji istodobno primaju više lijekova koji smanjuju pokretljivost crijeva i/ili one koji možda ne prijavljuju simptome konstipacije.
English: In a third short-term placebo-controlled monotherapy trial with Seroquel XR in children and adolescent patients (10-17 years of age) with bipolar depression, efficacy was not demonstrated.
Croatian: U trećem kratkoročnom, placebom kontroliranom ispitivanju monoterapije lijekom Seroquel XR u djece i adolescenata (u dobi od 10-17 godina) s bipolarnom depresijom, nije dokazana djelotvornost.
English: • The active substance is quetiapine.
Croatian: • Djelatna tvar je kvetiapin.
English: Your doctor may continue to prescribe Seroquel XR even when you feel better.
Croatian: Liječnik Vam može nastaviti davati Seroquel XR, čak i kada se osjećate bolje.
English: Toxic Epidermal Necrolysis, Erythema Multiforme
Croatian: toksična epidermalna nekroliza, multiformni eritem
English: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events).
Croatian: Depresija je povezana s povećanim rizikom od pojave suicidalnih misli, samoozljeđivanja i suicida (događaja povezanih sa suicidom).
English: • Decreases in the number of certain types of blood cells
Croatian: • smanjenja broja određenih vrsta krvnih stanica
English: Cardiomyopathy and Myocarditis
Croatian: Kardiomiopatija i miokarditis
English: Formal interaction studies with commonly used cardiovascular medicinal products have not been performed.
Croatian: Osnovna ispitivanja interakcija s često korištenim kardiovaskularnim lijekovima nisu provedena.
English: This could increase the occurrence of accidental injury (fall), especially in the elderly population.
Croatian: Ovo može povećati učestalost pojave ozljeda uslijed nezgoda (padovi), osobito kod starije populacije.
English: The rate of dose titration of Seroquel XR may need to be slower, and the daily therapeutic dose lower, than that used in younger patients.
Croatian: Brzina titriranja doze Seroquela XR možda će trebati biti sporija, a dnevna terapijska doza niža od one koja se primjenjuje mlađim bolesnicima.
English: Your doctor will decide on your starting dose.
Croatian: O početnoj dozi lijeka odlučit će Vaš liječnik.
English: • You have low blood pressure.
Croatian: • ako imate niski krvni tlak.
English: • Increase in blood pressure
Croatian: • povećanje krvnog tlaka
English: See text below 13.
Croatian: Vidjeti tekst niže.
English: If you take more Seroquel than you should
Croatian: Ako uzmete više Seroquela nego što ste trebali
English: Other medicines and Seroquel XR Tell your doctor if you are taking or have recently taken any other medicines .
Croatian: Drugi lijekovi i Seroquel XR Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove.
English: The incidence of these reactions had decreased significantly after 1 week postdiscontinuation.
Croatian: Incidencija ovih reakcija je značajno smanjena tjedan dana nakon prestanka uzimanja lijeka.
English: Whilst the prevention of absorption in overdose has not been investigated, gastric lavage can be indicated in severe poisonings and if possible to perform within one hour of ingestion.
Croatian: Premda prevencija apsorpcije u slučaju predoziranja nije ispitivana, ispiranje želuca u slučaju jakih trovanja može biti indicirano, te ga po mogućnosti valja obaviti unutar prvog sata od ingestije.
English: Tell your doctor if you are taking any of the following medicines:
Croatian: Obavijestite svog liječnika ako uzimate bilo koji od navedenih lijekova:
English: If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Croatian: Ako Vam se u bilo kojem trenutku jave misli o samoozljeđivanju ili samoubojstvu, odmah se javite svom liječniku ili otiđite u najbližu bolnicu.
English: It also blocks the action of dopamine agonists, measured either behaviourally or electrophysiologically, and elevates dopamine metabolite concentrations, a neurochemical index of D2-receptor blockade.
Croatian: Također blokira aktivnost dopaminskih agonista, što se određuje elektrofiziološki ili promjenama u ponašanju, te povisuje koncentraciju dopaminskih metabolita - neurokemijskih pokazatelja blokade D2 receptora.
English: It can affect the way the medicine works.
Croatian: Isti može utjecati na djelovanje lijeka u organizmu.
English: In addition, a 6-week placebo controlled study for the treatment of schizophrenia (n=222 patients, aged 13-17) was performed.
Croatian: Dodatno je provedeno 6-tjedno placebom kontrolirano ispitivanje u liječenju shizofrenije (n=222 bolesnika, 13-17 godina).
English: Keep the Seroquel tablets with you.
Croatian: Tablete Seroquela ponesite sa sobom.
English: Seroquel XR with food, drink and alcohol
Croatian: Seroquel XR s hranom, pićem i alkoholom
English: You should not take Seroquel XR during pregnancy unless this has been discussed with your doctor.
Croatian: Ne smijete uzimati Seroquel XR tijekom trudnoće ukoliko to prethodno nije raspravljeno s Vašim liječnikom.
English: • Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).
Croatian: • oštećenje mišićnih vlakana i bol u mišićima (rabdomioliza)
English: (For cataracts/lens opacities see section 5.1).
Croatian: (Za kataraktu/zamućenje leće vidjeti dio 5.1)
English: The pharmacokinetics of quetiapine were not significantly altered by co-administration of the antidepressants imipramine (a known CYP 2D6 inhibitor) or fluoxetine (a known CYP 3A4 and CYP 2D6 inhibitor).
Croatian: Farmakokinetika kvetiapina nije se znatnije promijenila kad se uzimao istodobno s antidepresivom imipraminom (poznati inhibitor CYP2D6) ili fluoksetinom (poznati inhibitor CYP3A4 i CYP2D6).
English: Note: The frequency is consistent to that observed in adults, but might be associated with different clinical implications in children and adolescents as compared to adults.
Croatian: Napomena: Učestalost je u skladu s onom primijećenom u odraslih, ali u djece i adolescenata nuspojave mogu biti povezane s drugačijim kliničkim implikacijama u usporedbi s odraslima.
English: Based on very limited data from published reports on quetiapine excretion into human breast milk, excretion of quetiapine at therapeutic doses appears to be inconsistent.
Croatian: Na temelju vrlo ograničenih podataka iz objavljenih izvješća o izlučivanju kvetiapina u majčino mlijeko, čini se da je izlučivanje kvetiapina nakon primjene terapijskih doza nedosljedno.
English: in elderly patients.
Croatian: Stariji bolesnici
English: • Swelling of breasts and unexpected production of breast milk (galactorrhoea).
Croatian: • oticanje dojki i neočekivano izlučivanje mlijeka iz dojki (galaktoreja)
English: When Seroquel XR is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another drug being used to treat this illness.
Croatian: Kada se Seroquel XR koristi za liječenje velikih depresivnih epizoda u velikom depresivnom poremećaju, on se uzima kao dodatna terapija uz drugi lijek za liječenje ove bolesti.
English: If you are having a urine drug screen, taking Seroquel may cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TCAs) when some test methods are used, even though you may not be taking methadone or TCAs.
Croatian: Ukoliko ste podvrgnuti probirnim testovima na lijekove u urinu, uzimanje Seroquela može uzrokovati pozitivne rezultate na metadon ili određene lijekove protiv depresije koji se zovu triciklički antidepresivi kada se koriste određenje metode testiranja, iako Vi možda ne uzimate metadon ili tricikličke antidepresive.
English: • Dizziness (may lead to falls), headache, dry mouth.
Croatian: • omaglica (može dovesti do padova), glavobolja, suhoća usta
English: QT Prolongation:
Croatian: QT prolongacija:
English: Depression in bipolar disorder is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events).
Croatian: Depresija u bipolarnom poremećaju je povezana s povećanim rizikom od pojave suicidalnih misli, samoozljeđivanja i suicida (događaja povezanih sa suicidom).
English: • Nefazodone (for depression).
Croatian: • nefazodon (za liječenje depresije).
English: Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: The mean dose of Seroquel XR during the randomised phase was 177 mg/day.
Croatian: Srednja doza Seroquela XR tijekom faze randomizacije bila je 177 mg/dnevno.
English: • Feeling like your heart is pounding, racing or has skipped beats.
Croatian: • osjećaj da Vaše srce lupa, vrlo brzo radi ili preskače otkucaje.
English: Other than the incidence of extrapyramidal symptoms (see section 4.8 and ‘Clinical Safety' below) the tolerability of Seroquel XR once daily in elderly patients was comparable to that seen in adults (aged 1865 years).
Croatian: Osim incidencije ekstrapiramidnih simptoma (vidjeti dio 4.8 i "Klinička sigurnost" niže), podnošljivost Seroquela XR primijenjenog jednom dnevno u starijih bolesnika usporediva je s onom uočenom kod odraslih (18 - 65 godina).
English: Distribution: Quetiapine is approximately 83% bound to plasma proteins.
Croatian: Distribucija: Oko 83% kvetiapina vezano je za proteine plazme.