FrancophonIA/ELRC3.0 huggingface dataset:
English: Clopidogrel/Acetylsalicylic acid Zentiva clopidogrel / acetylsalicylic acid
Croatian: klopidogrel/acetilsalicilna kiselina
English: Why has Clopidogrel/Acetylsalicylic acid Zentiva been approved?
Croatian: Zašto je lijek Klopidogrel/acetilsalicilna kiselina Zentiva odobren?
English: What is Clopidogrel/Acetylsalicylic acid Zentiva?
Croatian: Što je Klopidogrel/acetilsalicilna kiselina Zentiva?
English: What is Clopidogrel/Acetylsalicylic acid Zentiva used for?
Croatian: Za što se Klopidogrel/acetilsalicilna kiselina Zentiva koristi?
English: How is Clopidogrel/Acetylsalicylic acid Zentiva used?
Croatian: Kako se Klopidogrel/acetilsalicilna kiselina Zentiva koristi?
English: How does Clopidogrel/Acetylsalicylic acid Zentiva work?
Croatian: Kako djeluje Klopidogrel/acetilsalicilna kiselina Zentiva?
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Croatian: {Ime i adresa} <{tel}> <{fax}> <{e-mail}>
English: • Be careful how much alcohol you drink.
Croatian: • Budite oprezni s količinom alkohola koju konzumirate.
English: However, based on all available data, a definite conclusion cannot be drawn.
Croatian: Međutim, na temelju svih dostupnih podataka ne može se donijeti konačan zaključak.
English: You may be more likely to think like this if you are a young adult.
Croatian: Također, vjerojatnije je da ćete tako misliti ako ste mlađa odrasla osoba.
English: If this happens, a more specific test can be performed.
Croatian: Ukoliko se ovo dogodi, može se koristiti test koji je više specifičan.
English: The mechanism for this increased risk is not known.
Croatian: Mehanizam ovog povećanog rizika nije poznat.
English: It may harm them, even if their symptoms are the same as yours.
Croatian: Može im štetiti, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: • This medicine has been prescribed for you.
Croatian: • Ovaj je lijek propisan Vama.
English: The patients in these trials died from a variety of causes that were consistent with expectations for this population.
Croatian: U ovim ispitivanjima bolesnici su umrli od različitih uzroka koji su bili u skladu s očekivanjima za tu populaciju.
English: You and your doctor should check your weight regularly.
Croatian: Vi i Vaš liječnik trebate redovito provjeravati Vašu tjelesnu težinu.
English: • Disturbance in speech and language.
Croatian: • poremećaji u govoru i jeziku
English: • You will take your tablets once a day.
Croatian: • Svoje tablete uzimat ćete jednom dnevno.
English: This risk persists until significant remission occurs.
Croatian: Rizik je prisutan sve dok se ne postigne značajna remisija.
English: Very Rare Not known
Croatian: Vrlo rijetko Nepoznato
English: If you forget to take a dose, take it as soon as you remember.
Croatian: Zaboravite li uzeti dozu lijeka, uzmite je čim se sjetite.
English: An increased risk cannot be excluded for other antipsychotics or other patient populations.
Croatian: Povećanje rizika ne može se isključiti za druge antipsihotike ili druge populacije bolesnika.
English: • Abnormal dreams and nightmares
Croatian: • abnormalni snovi i noćne more
English: • Barbiturates (for difficulty sleeping).
Croatian: • barbiturate (zbog poteškoća sa spavanjem),
English: • Thoughts of suicide and worsening of your depression.
Croatian: • razmišljanje o samoubojstvu i pogoršanje Vaše depresije.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 27 April 1998
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA 27. travnja 1998.
English: The relevance of this finding for humans is unknown.
Croatian: Važnost ovog nalaza za ljude nije poznata.
English: This belongs to a group of medicines called antipsychotics.
Croatian: Ista pripada skupini lijekova koji se zovu antipsihotici.
English: You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Croatian: Također, možete ih i zamoliti da Vam kažu da li misle da se Vaša depresija pogoršava te da li su zabrinuti zbog promjena u Vašem ponašanju.
English: About 45% of the patient population had an additional diagnosis of ADHD.
Croatian: Otprilike 45% populacije bolesnika je imalo dodatno dijagnosticiran ADHD.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Informacije o lijeku mogu biti naknadno ažurirane od strane nadležnih tijela država članica, u dogovoru s referentnom državom članicom, ukoliko je prikladno, u skladu s postupcima navedenima u poglavlju 4 pod glavom III Direktive 2001/83/EC.
English: The proportion of randomized patients over 75 years of age was 19%.
Croatian: Udio randomiziranih bolesnika starijih od 75 godina bio je 19%.
English: The administration of activated charcoal should be considered.
Croatian: Potrebno je razmotriti i primjenu aktivnog ugljena.
English: • Uncontrollable movements, mainly of your face or tongue.
Croatian: • nekontrolirane kretnje, posebice Vašeg lica ili jezika.
English: It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition.
Croatian: Stoga se mora osigurati da bolesnici dobiju jasnu informaciju o prikladnom doziranju za njihovo stanje.
English: Metabolic Risk
Croatian: Metabolički rizik
English: • Abnormal muscle movements.
Croatian: • abnormalni pokreti mišića.
English: You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.
Croatian: Možda će Vam biti od pomoći ako kažete rođaku ili bliskom prijatelju da ste depresivni te ih zamolite da pročitaju ovu uputu.
English: Contact your doctor or nearest hospital straight away.
Croatian: Odmah se obratite svome liječniku ili u najbližu bolnicu.
English: These conditions can be caused by this type of medicine.
Croatian: Navedena stanja mogu biti uzrokovana ovom skupinom lijekova.
English: This leaflet was last approved in {MM/YYYY}.
Croatian: Ova uputa je zadnji puta odobrena u {MM/YYYY}.
English: Two short-term (6 week) studies enrolled patients who had shown an inadequate response to at least one antidepressant.
Croatian: Dva kratkoročna ispitivanja (6 tjedana) su uključivala bolesnike koji su pokazali neodgovarajući odgovor na najmanje jedan antidepresiv.
English: This is not recommended as standard treatment, because of potential negative effect of physostigmine on cardiac conductance.
Croatian: To se ne preporučuje kao standardno liječenje, zbog potencijalnog negativnog učinka fizostigmina na srčanu provodljivost.
English: • Inappropriate secretion of a hormone that controls urine volume.
Croatian: • neodgovarajuće izlučivanje hormona koji kontrolira volumen urina
English: There is an increased risk of adverse events at higher doses.
Croatian: Postoji povećan rizik od štetnih događaja pri višim dozama.
English: Different dosing schedules exist for each indication.
Croatian: Za svaku indikaciju postoji drugačiji raspored doziranja.
English: This pack contains:
Croatian: Ovo pakiranje sadrži:
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Croatian: Općenito, kliničko iskustvo je pokazalo da se rizik od suicida može povećati u ranim fazama oporavka.
English: Consequently, newborns should be monitored carefully.
Croatian: Stoga se novorođenčad mora pomno nadzirati.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Croatian: UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
English: It is important that the lowest effective dose is used for maintenance therapy.
Croatian: Važno je koristiti najnižu učinkovitu dozu lijeka u terapiji održavanja.
English: • You will take your tablets once a day, at bedtime or twice a day, depending on your illness
Croatian: • Svoje tablete uzimat ćete jednom dnevno prije spavanja ili dva puta dnevno, ovisno o Vašoj bolesti.
English: • Changes in the amount of certain fats (triglycerides and total cholesterol)
Croatian: • promjene u količini određenih masnoća (triglicerida i ukupnog kolesterola)
English: Weight should be monitored regularly.
Croatian: Tjelesna težina mora se redovito kontrolirati.
English: • Some medicines for HIV.
Croatian: • neke lijekove za liječenje HIV,
English: • Swallow your tablets whole with a drink of water.
Croatian: • Tablete progutajte cijele, s nešto vode.
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka):
English: • You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
Croatian: • ako ste u prošlosti imali niske razine bijelih krvnih stanica (koje su mogle ili nisu morale biti uzrokovane uzimanjem drugih lijekova).
English: CARTON AND LABEL FOR BOTTLE
Croatian: KUTIJA I NALJEPNICA BOCE
English: Individual dosage adjustments may be necessary.
Croatian: Pri tome može biti potrebna individualna prilagodba doze.
English: Your doctor may ask you to have blood tests from time to time.
Croatian: Vaš liječnik može zatražiti da se povremeno podvrgnete pretragama krvi.
English: If it is almost time to take the next dose, wait until then.
Croatian: Ukoliko se bliži vrijeme uobičajenog uzimanja sljedeće doze, pričekajte do tada.
English: This is most likely to occur within the first few weeks of treatment.
Croatian: Ovo će se najvjerojatnije pojaviti u prvih nekoliko tjedana liječenja.
English: Severe Neutropenia and agranulocytosis:
Croatian: Teška neutropenija i agranulocitoza:
English: • Do not store above 30°C.
Croatian: • Ne čuvati na temperaturi iznad 30°C.
English: There is no specific antidote to quetiapine.
Croatian: Nema specifičnog antidota za kvetiapin.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Croatian: Obzirom da se poboljšanje ne mora javiti tijekom prvih nekoliko tjedana liječenja ili duže, bolesnike se mora pomno nadzirati sve dok ne dođe do takvog poboljšanja.
English: • Walking, talking , eating or other activities while you are asleep.
Croatian: • hodanje, govor, jedenje ili druge aktivnosti za vrijeme trajanja
English: Warnings and Precautions
Croatian: Upozorenja i mjere opreza
English: Some side effects are only seen when a blood test is taken.
Croatian: Neke nuspojave mogu se uočiti samo ukoliko se učine krvne pretrage.
English: • Vomiting (mainly in the elderly).
Croatian: • povraćanje (uglavnom kod starijih osoba)
English: During post-marketing experience, some cases were fatal.
Croatian: Tijekom primjene nakon stavljanja lijeka u promet, neki slučajevi su bili fatalni.
English: Physostigmine may be used if there are no ECG aberrations.
Croatian: Fizostigmin se može primijeniti ukoliko nema EKG aberacija.
English: Before you stop taking any of your medicines, please talk to your doctor first.
Croatian: Prije nego što prestanete uzimati bilo koji od lijekova koje inače uzimate, prvo razgovarajte sa svojim liječnikom.
English: Tell your doctor as soon as possible if you have:
Croatian: Što prije obavijestite svog liječnika ako imate:
English: It is also not recommended to consume grapefruit juice while on quetiapine therapy.
Croatian: Također se ne preporuča konzumiranje soka od grejpa tijekom liječenja kvetiapinom.
English: • Bipolar depression: where you feel sad.
Croatian: • Bipolarna depresija: stanje u kojem ste tužni.
English: Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.
Croatian: Stoga se bolesnicima mora savjetovati oprez dok ne budu upoznati s mogućim učincima lijeka.
English: Metabolic syndrome29
Croatian: metabolički sindrom29
English: Approximately 73% of the radioactivity is excreted in the urine and 21% in the faeces.
Croatian: Približno 73% radioaktivnosti se izlučuje u urinu i 21% u fecesu.
English: In addition, these conditions may be co-morbid with major depressive episodes.
Croatian: Dodatno, ova stanja mogu biti komorbiditet uz velike depresivne epizode.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Croatian: Istraživanja na životinjama ukazala su na reproduktivnu toksičnost (vidjeti dio 5.3).
English: The recommended daily dose is 300 mg.
Croatian: Preporučena dnevna doza je 300 mg.
English: There were no additional safety findings associated with treatment with Seroquel XR for up to 9 months (median 7 months).
Croatian: Nije bilo dodatnih sigurnosnih pitanja povezanih s liječenjem Seroquelom XR u trajanju do 9 mjeseci (medijan 7 mjeseci).
English: If you notice any of these symptoms seek medical advice immediately.
Croatian: Ako primijetite bilo koji od navedenih simptoma odmah potražite liječničku pomoć.
English: • Menstrual disorder.
Croatian: • menstrualni poremećaj
English: Always take Seroquel exactly as your doctor has told you.
Croatian: Uvijek uzmite Seroquel točno onako kako Vam je rekao Vaš liječnik.
English: Suicide/suicidal thoughts or clinical worsening:
Croatian: Suicid/suicidalne misli ili kliničko pogoršanje:
English: • You or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Croatian: • ako Vi ili netko od članova Vaše obitelji u povijesti bolesti ima krvne ugruške, obzirom da su lijekovi poput ovog povezani s nastajanjem krvnih ugrušaka.
English: The moderate amount of published data from exposed pregnancies (i.e. between 300-1000 pregnancy outcomes), including individual reports and some observational studies do not suggest an increased risk of malformations due to treatment.
Croatian: Umjerena količina objavljenih podataka o izloženim trudnoćama (tj. između 300 i 1000 ishoda trudnoće), uključujući pojedinačne prijave i neka opservacijska ispitivanja, ne ukazuju na povećan rizik od malformacija uzrokovanih liječenjem.
English: However, some cases occurred in patients without pre-existing risk factors.
Croatian: bilo je slučajeva pojave kod bolesnika bez prethodno postojećih faktora rizika.
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Croatian: U bolesnika kod kojih se pojave ovi simptomi povećanje doze može biti štetno.
English: In addition, physicians should consider the potential risk of suicide-related events after abrupt cessation of quetiapine treatment, due to the known risk factors for the disease being treated.
Croatian: Dodatno, liječnik mora razmotriti mogući rizik od događaja povezanih sa suicidom nakon naglog prekida liječenja kvetiapinom, zbog poznatih faktora rizika bolesti koja se liječi.
English: Somnambulism and related reactions such as sleep talking and sleep related eating disorder
Croatian: somnambulizam i srodne reakcije poput govora u snu i poremećaja prehrane povezanog sa spavanjem
English: There are no data from long-term studies to demonstrate Seroquel's effectiveness in preventing subsequent manic or depressive episodes.
Croatian: Ne postoje podaci iz dugoročnih ispitivanja koji dokazuju učinkovitost Seroquela u sprječavanju naknadnih maničnih ili depresivnih epizoda.
English: Quetiapine is active in tests for antipsychotic activity, such as conditioned avoidance.
Croatian: Kvetiapin je aktivan u testovima za antipsihotičku aktivnost, npr. u uvjetovanom izbjegavanju.
English: Dose adjustments may be necessary in these patients (see section 4.2).
Croatian: U tih bolesnika može biti potrebna prilagodba doze (vidjeti dio 4.2).
English: The average dose was 669 mg.
Croatian: Prosječna terapijska doza lijeka iznosila je 669 mg.
English: In both studies, patients with known lack of response to Seroquel were excluded.
Croatian: U oba ispitivanja, isključeni su bolesnici s poznatim nedostatkom odgovora na Seroquel.
English: • Dizziness or a severe sense of feeling sleepy.
Croatian: • omaglicu ili jaki osjećaj pospanosti.
English: • Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
Croatian: • Manija: stanje u kojem se možete osjećati vrlo uzbuđeno, ushićeno, uznemireno, entuzijastično ili hiperaktivno; ili možete biti u stanju poremećene prosudbe koje uključuje agresivno ili razorno ponašanje.
English: The following side effects have been seen more often in children and adolescents or have not been seen in adults:
Croatian: Sljedeće nuspojave su uočene češće u djece i adolescenata, ili nisu bile uočene kod odraslih:
English: Quetiapine is an atypical antipsychotic agent.
Croatian: Kvetiapin je atipični antipsihotik.
English: • Seroquel XR does not require any special storage conditions.
Croatian: • Seroquel XR ne zahtijeva posebne uvjete čuvanja.
English: Seroquel with food, drink and alcohol
Croatian: Seroquel s hranom, pićem i alkoholom
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Croatian: Ovaj sažetak opisa svojstava lijeka, označavanje i uputa o lijeku su ishod arbitražnog postupka na koji se odnosi ova odluka Komisije.
English: Do not drive or use any tools or machines until you know how the tablets affect you.
Croatian: Nemojte voziti i nemojte koristiti alate niti strojeve sve dok ne utvrdite kako ove tablete utječu na Vas.
English: This effect occurred in the presence of overt maternal effects such as reduced body weight gain.
Croatian: Ovaj učinak se pojavljivao u prisutnosti očiglednih učinaka na majku kao što je smanjen porast tjelesne težine.
English: • Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.
Croatian: • Shizofrenija: stanje u kojem možete čuti ili osjećati nešto što ne postoji, vjerovati u nešto što nije istinito ili osjećati neobičnu sumnjičavost, tjeskobu, smetenost, krivnju, napetost ili potištenost.
English: • A slower than normal heart rate which may occur when starting treatment and which may be associated with low blood pressure and fainting.
Croatian: • sporiji puls (srčana frekvencija) nego obično, što se može javiti na početku liječenja i može biti povezano s niskim krvnim tlakom i nesvjesticom
English: • Increased appetite
Croatian: • povećani apetit
English: • Low blood pressure when standing up.
Croatian: • nizak krvni tlak pri ustajanju.
English: Based upon the increased rate of vomiting in elderly patients (≥65 years of age).
Croatian: Temeljeno na povećanoj stopi povraćanja kod starijih bolesnika (≥65 godina).
English: Efficacy and safety has not been evaluated in patients over 65 years with depressive episodes in the framework of bipolar disorder.
Croatian: Djelotvornost i sigurnost nije procijenjena u bolesnika starijih od 65 godina koji pate od depresivnih epizoda u okviru bipolarnog poremećaja.
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 može biti predisponirajući faktor.
English: Individual patients may benefit from a 600 mg dose.
Croatian: Pojedini bolesnici mogu imati koristi od primjene doze od 600 mg.
English: Shifts in total T4, free T4, total T3 and free T3 are defined as <0.8 x LLN (pmol/L) and shift in TSH is > 5 mIU/L at any time.
Croatian: Pomaci u ukupnom T4, slobodnom T4, ukupnom T3 i slobodnom T3 su definirani kao <0,8 x LLN (pmol/L), i pomak u TSH je >5 mIU/L u bilo kojem trenutku.
English: These may be increased when first starting treatment, since these medicines all take time to work, usually about two weeks but sometimes longer.
Croatian: Do pojave takvih misli može češće doći na početku liječenja, s obzirom da ovoj skupini lijekova treba određeno vrijeme, obično oko dva tjedna, ali ponekad i dulje, da počnu djelovati.
English: Norquetiapine is primarily formed and eliminated via CYP3A4.
Croatian: Norkvetiapin se uglavnom stvara i eliminira putem CYP3A4.
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Croatian: Bolesnike (i njihove skrbnike) se mora upozoriti da je potrebno pratiti bilo kakvo kliničko pogoršanje, suicidalno ponašanje ili misli i neobične promjene ponašanja te da odmah potraže liječnički savjet ukoliko su ovi simptomi prisutni.
English: Other psychiatric conditions for which quetiapine is prescribed can also be associated with an increased risk of suicide related events.
Croatian: Druga psihijatrijska stanja za koja se propisuje kvetiapin mogu također biti povezana s povećanim rizikom od događaja povezanih sa suicidom.
English: If your baby develops any of these symptoms you may need to contact your doctor.
Croatian: Ukoliko Vaše dijete ima bilo koji od ovih simptoma, morate se javiti liječniku.
English: • A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock.
Croatian: • teška alergijska reakcija (nazvana anafilaksija), koja može uzrokovati otežano disanje ili izazvati šok
English: You should not take Seroquel during pregnancy unless this has been discussed with your doctor.
Croatian: Ne smijete uzimati Seroquel tijekom trudnoće ukoliko to prethodno nije raspravljeno s Vašim liječnikom.
English: • Epilepsy medicines (like phenytoin or carbamazepine).
Croatian: • lijekove za epilepsiju (kao što su fenitoin ili karbamazepin),
English: The tablets should be swallowed whole and not split, chewed or crushed.
Croatian: Tablete se moraju progutati cijele, ne smije ih se prepoloviti, žvakati ili smrviti.
English: Furthermore, the long-term safety implications of treatment with quetiapine on growth and maturation have not been studied beyond 26 weeks.
Croatian: Nadalje, sigurnost dugotrajnog liječenja kvetiapinom i njegov utjecaj na rast i razvoj nisu ispitivani dulje od 26 tjedana.
English: Epinephrine and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of quetiapine-induced alpha blockade.
Croatian: Adrenalin i dopamin moraju se izbjegavati, budući da beta stimulacija može pogoršati hipotenziju u uvjetima alfa blokade uzrokovane kvetiapinom.
English: These effects were apparent at maternal exposure levels similar or slightly above those in humans at the maximal therapeutic dose.
Croatian: Ovi učinci su bili vidljivi pri razinama izloženosti majke koje su bile slične ili neznatno veće od izloženosti kod ljudi pri maksimalnoj terapijskoj dozi.
English: There have been reports of false positive results in enzyme immunoassays for methadone and tricyclic antidepressants in patients who have taken quetiapine.
Croatian: Prijavljeni su lažno pozitivni rezultati u enzimskim imunotestovima na metadon i tricikličke antidepresive kod bolesnika koji su uzimali kvetiapin.
English: (See section 4.4, Orthostatic hypotension ).
Croatian: (vidjeti dio 4.4, Ortostatska hipotenzija).
English: Biotransformation:
Croatian: Biotransformacija:
English: • You are an elderly person with dementia (loss of brain function).
Croatian: • ako ste u starijoj životnoj dobi i bolujete od demencije (smanjenje moždane funkcije).
English: The AUC and Cmax for the active metabolite, norquetiapine, were higher, approximately 62% and 49% in children (10-12 years), respectively and 28% and 14% in adolescents (13-17 years), respectively, compared to adults.
Croatian: AUC i Cmax za aktivni metabolit, norkvetiapin, bili su viši, približno 62% i 49% u djece (10-12 godina) te 28% i 14% u adolescenata (13-17 godina) u usporedbi s odraslima.
English: Occurs predominantly during the early weeks of treatment in adults.
Croatian: Pojavljuje se naročito u prvim tjednima liječenja u odraslih.
English: • Change in electrical activity of the heart seen on ECG (QT prolongation)
Croatian: • promjena električne aktivnosti srca vidljive na EKG-u (produljenje QT intervala)