FrancophonIA/ELRC3.0 huggingface dataset:
English: However, some cases occurred in patients without pre-existing risk factors.
Slovenian: Vendar pa so se nekateri primeri pojavili tudi pri bolnikih brez obstoječih dejavnikov tveganja.
English: Consequently, newborns should be monitored carefully.
Slovenian: Zato je treba novorojenčke skrbno spremljati.
English: This risk persists until significant remission occurs.
Slovenian: Takšno tveganje obstaja, vse dokler ne pride do znatnega umika bolezni.
English: The average dose was 669 mg.
Slovenian: Povprečni odmerek je bil 669 mg.
English: You and your doctor should check your weight regularly.
Slovenian: Vi sami in vaš zdravnik morate redno kontrolirati vašo telesno maso.
English: (16) May lead to falls.
Slovenian: (16) Lahko povzroči padce.
English: (12) See text below
Slovenian: (12) Glejte besedilo spodaj.
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.
Slovenian: Prosite ga lahko tudi, da naj vas opozori, če meni, da se je depresija poslabšala ali ga skrbijo spremembe v vašem vedenju.
English: Decreases in free T3
Slovenian: znižanje prostega T3
English: This belongs to a group of medicines called antipsychotics.
Slovenian: Spada v skupino zdravil, ki jih imenujemo antipsihotiki.
English: Gradual withdrawal over a period of at least 1 to 2 weeks is advisable.
Slovenian: Priporočljiva je postopna opustitev v obdobju vsaj 1 do 2 tednov.
English: Two short-term (6 week) studies enrolled patients who had shown an inadequate response to at least one antidepressant.
Slovenian: Dve kratkotrajni (6-tedenski) študiji sta vključili bolnike, ki so se neustrezno odzvali na vsaj en antidepresiv.
English: • Disturbance in speech and language.
Slovenian: • motnje pri govoru, jeziku,
English: These thoughts may also be increased if you suddenly stop taking your medication.
Slovenian: Takšne misli lahko postanejo hujše, če nenadno prenehate z jemanjem vašega zdravila.
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Slovenian: V nekaterih primerih so ugotovili predhodno povečanje telesne mase, kar bi lahko bil predispozicijski dejavnik.
English: • Change in electrical activity of the heart seen on ECG (QT prolongation)
Slovenian: • sprememba v električni aktivnosti srca, ki se vidi na EKG (podaljšanje intervala QT),
English: It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition.
Slovenian: Zato je treba zagotoviti, da bolniki dobijo jasne informacije o ustreznem odmerjanju za njihovo bolezen.
English: You may be more likely to think like this if you are a young adult.
Slovenian: Pojav takšnih misli se vam verjetneje pojavi, če ste mladi odrasli.
English: • You will take your tablets once a day, at bedtime or twice a day, depending on your illness
Slovenian: • Tablete boste jemali enkrat na dan pred spanjem ali dvakrat na dan, odvisno od vaše bolezni.
English: Close medical supervision and monitoring should be continued until the patient recovers.
Slovenian: Natančen zdravniški nadzor in spremljanje sta potrebna, dokler si bolnik ne opomore.
English: • You have problems with your liver.
Slovenian: • imate težave z jetri,
English: If your baby develops any of these symptoms you may need to contact your doctor.
Slovenian: Če vaš otrok razvije katerega koli od teh simptomov, se boste morda morali posvetovati s svojim zdravnikom.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Slovenian: Splošne klinične izkušnje kažejo, da se tveganje za samomor v zgodnji fazi izboljšanja lahko poveča.
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.
Slovenian: • imate vi ali kdo v vaši družini zgodovino nastanka krvnih strdkov, saj so ta zdravila povezana z nastankom krvnih strdkov.
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.
Slovenian: Zmeren obseg objavljenih podatkov o izpostavljenih nosečnostih (med 300-1000 izidov nosečnosti), vključno s posameznimi poročili in nekaj opazovalnimi študijami, ne kaže povečanega tveganja za pojav malformacij zaradi zdravljenja.
English: There was no apparent dose relationship.
Slovenian: Očitne povezanosti z odmerkom ni bilo.
English: Therefore, quetiapine should only be used during pregnancy if the benefits justify the potential risks.
Slovenian: Kvetiapin se sme zato uporabljati med nosečnostjo le, če koristi zdravljenja upravičujejo možna tveganja.
English: No data are available on maintenance of effect or recurrence prevention in this age group.
Slovenian: Podatkov o vzdrževanju učinka ali preprečevanju ponovitve za to starostno skupino ni.
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Slovenian: Priporočljivo je ustrezno klinično spremljanje v skladu z uporabljanimi smernicami za antipsihotike.
English: This is not recommended as standard treatment, because of potential negative effect of physostigmine on cardiac conductance.
Slovenian: To ni priporočljivo kot standardno zdravljenje in sicer zaradi potencialnega negativnega učinka fizostigmina na prevodnost srca.
English: • Dizziness or a severe sense of feeling sleepy.
Slovenian: • omotica ali občutek hude zaspanosti.
English: Formal interaction studies with commonly used cardiovascular medicinal products have not been performed.
Slovenian: Formalne študije medsebojnega delovanja s pogosto uporabljanimi srčno-žilnimi zdravili niso bile izvedene.
English: Your doctor may suggest you reduce the dose gradually before stopping treatment.
Slovenian: Zdravnik vam bo morda svetoval, da pred opustitvijo zdravila odmerek zmanjšujete postopoma.
English: An increased risk cannot be excluded for other antipsychotics or other patient populations.
Slovenian: Večjega tveganja ni mogoče izključiti za druga antipsihotična zdravila ali druge populacije bolnikov.
English: • You have had a stroke, especially if you are elderly
Slovenian: • ste imeli možgansko kap, zlasti če ste starejši,
English: The available evidence from placebo-controlled clinical trials is presented in sections 4.4, 4.8, 5.1 and 5.2.
Slovenian: Ugotovitve s placebom kontroliranih kliničnih preskušanj so predstavljene v poglavjih 4.4, 4.8, 5.1 in 5.2.
English: Your doctor may ask you to have blood tests from time to time.
Slovenian: Zdravnik vas bo zato morda občasno napotil na preiskavo krvi.
English: Lipid changes should be managed as clinically appropriate.
Slovenian: Spremembe lipidov naj bodo zdravljene, kot je klinično primerno.
English: These conditions can be caused by this type of medicine.
Slovenian: Te znake lahko povzroči ta skupina zdravil.
English: Efficacy and safety has not been evaluated in patients over 65 years with depressive episodes in the framework of bipolar disorder.
Slovenian: Učinkovitost in varnost nista ocenjeni pri bolnikih, starejših od 65 let, z depresivnimi epizodami v okviru bipolarne motnje.
English: Approximately 73% of the radioactivity is excreted in the urine and 21% in the faeces.
Slovenian: Približno 73 % radioaktivnosti se izloči v urinu in 21 % v blatu.
English: For these patients, the mean maximum decrease in hemoglobin at any time was -1.50 g/dL.
Slovenian: Pri teh bolnikih, je bilo povprečno največje znižanje hemoglobina kadarkoli -1,50 g/dl.
English: • Some medicines for HIV.
Slovenian: • nekatera zdravila za zdravljenje HIV,
English: • Feeling more hungry
Slovenian: • občutek večje lakote,
English: Some side effects are only seen when a blood test is taken.
Slovenian: Nekateri neželeni učinki se lahko odkrijejo le s preiskavo krvi.
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Slovenian: Ta Povzetek glavnih značilnosti zdravila, Ovojnina in Navodilo za uporabo so rezultat napotitvenega postopka, s katerim je povezana odločitev Komisije.
English: The recommended daily dose is 300 mg.
Slovenian: Priporočeni dnevni odmerek je 300 mg.
English: Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.
Slovenian: Zato je treba bolnikom naročiti, naj bodo previdni, dokler ne spoznajo možnih učinkov zdravila.
English: Contact your doctor or nearest hospital straight away.
Slovenian: Takoj pojdite do svojega zdravnika ali v najbližjo bolnišnico.
English: • Increased appetite
Slovenian: • povečan apetit,
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Slovenian: Bolnikom, ki se jim pojavijo ti simptomi, lahko povečanje odmerka škoduje.
English: There is no specific antidote to quetiapine.
Slovenian: Specifičnega antidota za kvetiapin ni.
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.
Slovenian: • shizofrenije: ko lahko slišite ali zaznavate stvari, ki jih ni, verjamete v stvari, ki niso resnične ali se počutite nenavadno sumničave, zaskrbljene, zmedene, krive, napete ali depresivne.
English: You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.
Slovenian: Morda bi bilo koristno, če za težave z depresijo poveste sorodniku ali dobremu prijatelju, in ga prosite, da prebere to navodilo.
English: The maintenance dose (daily dose) will depend on your illness and needs but will usually be between 150 mg and 800 mg.
Slovenian: Vzdrževalni odmerek (dnevni odmerek) bo odvisen od vaše bolezni in potreb, a praviloma je odmerek med 150 mg in 800 mg.
English: All prolonged-release tablets are capsule shaped and marked with XR and the strength.
Slovenian: Vse tablete s podaljšanim sproščanjem so kapsulaste oblike in označene z oznako »XR« in jakostjo.
English: There are no data from long-term studies to demonstrate Seroquel's effectiveness in preventing subsequent manic or depressive episodes.
Slovenian: Ni podatkov iz dolgotrajnih študij, ki bi pokazali učinkovitost zdravila Seroquel pri preprečevanju poznejših maničnih ali depresivnih epizod.
English: Individual patients may benefit from a 600 mg dose.
Slovenian: Posameznim bolnikom lahko koristi odmerek 600 mg.
English: • You can take your tablets with or without food.
Slovenian: • Tablete lahko jemljete s hrano ali brez.
English: In laboratory animals at a clinically relevant exposure level the following deviations were seen, which as yet have not been confirmed in long-term clinical research:
Slovenian: Pri laboratorijskih živalih so ob klinično pomembni ravni izpostavljenosti opažali naslednje odklone, ki pa v dolgoročnih kliničnih raziskavah doslej še niso bili potrjeni:
English: Quetiapine is an atypical antipsychotic agent.
Slovenian: Kvetiapin je atipični antipsihotik.
English: If you notice any of these symptoms seek medical advice immediately.
Slovenian: Če opazite katerega od teh simptomov nemudoma poiščite zdravniško pomoč.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Slovenian: Ker se prvih nekaj tednov zdravljenja ali dlje zdravstveno stanje morda še ne bo izboljšalo, je potrebno bolnike skrbno nadzirati, vse dokler ne pride do izboljšanja.
English: Do not drive or use any tools or machines until you know how the tablets affect you.
Slovenian: Ne vozite in ne upravljajte strojev, dokler ne veste, kako te tablete vplivajo na vas.
English: An increase in LDL cholesterol of ≥30 mg/dL
Slovenian: Povečanje LDL holesterola ≥ 30 mg/dl
English: Mechanism of action:
Slovenian: Mehanizem delovanja:
English: Physostigmine may be used if there are no ECG aberrations.
Slovenian: Fizostigmin se lahko uporablja le, če ni nobenih motenj EKG.
English: Most cases of severe neutropenia have occurred within a couple of months of starting therapy with quetiapine.
Slovenian: Večina primerov hude nevtropenije se je pojavila v nekaj mesecih po začetku zdravljenja s kvetiapinom.
English: CARTON AND LABEL FOR BOTTLE
Slovenian: ŠKATLA IN NALEPKA ZA PLASTENKO
English: However, based on all available data, a definite conclusion cannot be drawn.
Slovenian: Kljub temu dokončnega sklepa, na podlagi vseh podatkov ki so na voljo, ni mogoče narediti.
English: Therefore, patients should be advised not to drive or operate machinery, until individual susceptibility to this is known.
Slovenian: Zato je potrebno bolnikom svetovati, da ne vozijo ali upravljajo s stroji, dokler ni znana njihova individualna dovzetnost za ta učinek.
English: Mean change among patients who had this increase was 41.7 mg/dL (≥1.07 mmol/L).
Slovenian: Povprečna sprememba pri bolnikih, ki imajo to povečanje je bila 41,7 mg/dl (≥ 1,07 mmol/l).
English: (8) Based on >7% increase in body weight from baseline.
Slovenian: (8) Na podlagi >7 % povečanja telesne mase v primerjavi z izhodiščem.
English: Dose adjustments may be necessary in these patients (see section 4.2).
Slovenian: Pri teh bolnikih utegnejo biti potrebne prilagoditve odmerka (glejte poglavje 4.2).
English: It is important that the lowest effective dose is used for maintenance therapy.
Slovenian: Pomembno je, da za vzdrževalno zdravljenje uporabimo najnižji še učinkovit odmerek zdravila.
English: As a consequence of this interaction, lower plasma concentrations can occur, which could affect the efficacy of quetiapine therapy.
Slovenian: Kot posledica tega medsebojnega delovanja lahko pride do nižjih plazemskih koncentracij, kar lahko vpliva na učinkovitost zdravljenja s kvetiapinom.
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.
Slovenian: Na podlagi zelo omejenih podatkov iz objavljenih poročil o izločanju kvetiapina v materino mleko pri človeku kaže, da je izločanje kvetiapina v terapevtskih odmerkih nekonsistentno.
English: • Walking, talking , eating or other activities while you are asleep.
Slovenian: • hoja, govorjenje, uživanje hrane ali druge dejavnosti med spanjem,
English: Metabolic syndrome29
Slovenian: metabolični sindrom29
English: In both studies, patients with known lack of response to Seroquel were excluded.
Slovenian: Iz obeh študij so bili izključeni bolniki, za katere je bilo znano, da se ne odzovejo na zdravilo Seroquel.
English: Occurs predominantly during the early weeks of treatment in adults.
Slovenian: Pojavi se pretežno v prvih tednih zdravljenja pri odraslih.
English: This pack contains:
Slovenian: To pakiranje vsebuje:
English: For 3Day Starterpack pack size of 8 tablets is registered and for 4-Day Starterpack pack size of 10 tablets is registered.
Slovenian: Za 3-dnevno začetno pakiranje je registrirano pakiranje po 8 tablet in za 4-dnevno začetno pakiranje je registrirano pakiranje po 10 tablet.
English: (≥0.769 mmol/L) has been very commonly observed.
Slovenian: (≥ 0,769 mmol/l) je bilo opisano v zelo pogostih primerih.
English: Neutropenia 1
Slovenian: nevtropenija 1
English: • Body temperature decreased (hypothermia).
Slovenian: • znižana telesna temperatura (hipotermija),
English: Worsening in these parameters should be managed as clinically appropriate (see also section 4.8).
Slovenian: Poslabšanje teh parametrov je treba obravnavati, kot je klinično ustrezno (glejte tudi poglavje 4.8).
English: • Menstrual disorder.
Slovenian: • menstruacijske motnje,
English: In cases of quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents.
Slovenian: V primerih prevelikega odmerjanja kvetiapina je treba refraktarno hipotenzijo zdraviti z ustreznimi ukrepi, npr. intravenskimi tekočinami in/ali simpatikomimetičnimi zdravili.
English: The administration of activated charcoal should be considered.
Slovenian: Lahko razmislimo tudi o uporabi aktivnega oglja.
English: The proportion of randomized patients over 75 years of age was 19%.
Slovenian: Delež randomiziranih bolnikov, starejših od 75 let, je bil
English: The following side effects have been seen more often in children and adolescents or have not been seen in adults:
Slovenian: Naslednji neželeni učinki so bili pri otrocih in mladostnikih pogostejši ali pri odraslih niso bili ugotovljeni:
English: Quetiapine is active in tests for antipsychotic activity, such as conditioned avoidance.
Slovenian: Kvetiapin je aktiven v testih antipsihotičnega delovanja, npr. pogojevanem izogibanju.
English: • Medicines that can cause constipation.
Slovenian: • zdravila, ki lahko povzročijo zaprtost.
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.
Slovenian: To dodatno podpirajo podatki študije s pozitronsko emisijsko tomografijo (PET), kjer so ugotovili, da so receptorji 5HT2 in D2 zasedeni s kvetiapinom do 12 ur.
English: These effects were apparent at maternal exposure levels similar or slightly above those in humans at the maximal therapeutic dose.
Slovenian: Ti učinki so bili opazni pri izpostavljenosti samic-mater, ki je bila podobna ali rahlo večja od izpostavljenosti pri človeku ob največjem terapevtskem odmerku.
English: (25) Based upon the increased rate of vomiting in elderly patients (≥65 years of age).
Slovenian: (25) Na podlagi večje pogostnosti bruhanja med starejšimi bolniki (starimi ≥ 65 let).
English: These elevations were usually reversible on continued quetiapine treatment.
Slovenian: Ta zvišanja so bila med nadaljevanjem zdravljenja s kvetiapinom ponavadi reverzibilna.
English: • Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
Slovenian: • hitro otekanje kože, običajno okoli oči, ustnic in grla (angioedem),
English: Pharmacotherapeutic group: Antipsychotics ATC code: N05A H04
Slovenian: Farmakoterapevtska skupina: antipsihotiki Oznaka ATC: N05A H04
English: • Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Slovenian: • Tudi če se počutite bolje, ne nehajte jemati tablet razen, če vam tega ne naroči zdravnik.
English: • Thoughts of suicide and worsening of your depression.
Slovenian: • razmišljanje o samomoru ali poslabšanje depresije,
English: The efficacy and safety of Seroquel was studied in a 3-week placebo controlled study for the treatment of mania (n= 284 patients from the US, aged 10-17).
Slovenian: Učinkovitost in varnost zdravila Seroquel so raziskali v 3-tedenski, s placebom kontrolirani študiji za zdravljenje manije (n = 284 bolnikov v ZDA, starih od 10 do 17 let).
English: Other psychiatric conditions for which quetiapine is prescribed can also be associated with an increased risk of suicide related events.
Slovenian: Druga psihiatrična stanja za katere se predpisuje kvetiapin so lahko tudi povezana s povečanjem tveganja za dogodke, povezane s samomorom.
English: The incidence of these reactions had decreased significantly after 1 week post-discontinuation.
Slovenian: Incidenca simptomov se je signifikantno zmanjšala po enem tednu po odtegnitvi.
English: There was no difference in magnitude of effect between the patients who received 300 mg Seroquel IR and those who received 600 mg dose.
Slovenian: Velikost učinka se ni razlikovala med bolniki, ki so dobivali 300 mg zdravila Seroquel, in tistimi, ki so dobivali odmerek 600 mg.
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.
Slovenian: Opomba: Pogostnost se ujema z ugotovljeno pri odraslih, toda pri otrocih in mladostnikih ima lahko drugačne klinične posledice kot pri odraslih.
English: • Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
Slovenian: • manije: ko se lahko počutite vzhičene, pretirano vesele, polne zanosa, entuziazma, ste hiperaktivni ali zmožni slabe presoje, vključno z agresivnostjo ali razdražljivostjo.
English: • Changes in the amount of certain fats (triglycerides and total cholesterol)
Slovenian: • spremembe koncentracije določenih maščob v krvi (trigliceridov in celokupnega holesterola).
English: The long-term efficacy of Seroquel IR in prevention of schizophrenic relapses has not been verified in blinded clinical trials.
Slovenian: Dolgoročna učinkovitost zdravila Seroquel za preprečevanje recidivov shizofrenije ni preverjena v slepljenih kliničnih preskušanjih.
English: Your doctor will decide on your starting dose.
Slovenian: Zdravnik bo odločil, kolikšen začetni odmerek potrebujete.
English: The effects of quetiapine on human fertility have not been assessed.
Slovenian: Učinki kvetiapina na plodnost pri človeku niso ugotovljeni.
English: Hypersensitivity (including allergic skin reactions)
Slovenian: Bolezni imunskega sistema preobčutljivost (vključno z alergijskimi kožnimi reakcijami)
English: These effects are related to elevated prolactin levels and not directly relevant to humans because of species differences in hormonal control of reproduction.
Slovenian: Ti učinki so povezani z zvišano koncentracijo prolaktina in za človeka niso neposredno pomembni zaradi razlik v hormonskem nadzoru reprodukcije med vrstama.
English: • Decrease in the amount of red blood cells
Slovenian: • zmanjšanje števila rdečih krvnih celic,
English: Confirmation of questionable immunoassay screening results by an appropriate chromatographic technique is recommended.
Slovenian: Priporoča se potrditev rezultatov encimskih preiskav s primerno kromatografsko tehniko.
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.
Slovenian: Če je na podlagi ocene posameznega bolnika odmerek treba povečati na 300 mg/dan, se tega ne sme narediti prej kot 22. dan zdravljenja.
English: Given the primary central nervous system effects of quetiapine, quetiapine should be used with caution in combination with other centrally acting medicinal products and alcohol.
Slovenian: Glede na primarne učinke kvetiapina na osrednji živčni sistem moramo biti previdni pri uporabi kvetiapina v kombinaciji z drugimi zdravili s centralnim delovanjem in pitjem alkohola.
English: • treatment of bipolar disorder:
Slovenian: • zdravljenje bipolarne motnje:
English: 25 mg tablets
Slovenian: 25 mg tablete
English: • Vomiting (mainly in the elderly).
Slovenian: • bruhanje (predvsem pri starejših),
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.
Slovenian: Incidenca recipročnih, potencialno klinično pomembnih sprememb T3 ali T4 in TSH je bila v teh preskušanjih majhna in opažene spremembe koncentracije ščitničnih hormonov niso bile povezane s klinično simptomatskim hipotiroidizmom.
English: This is most likely to occur within the first few weeks of treatment.
Slovenian: Pojav tega je najverjetnejši v prvih tednih zdravljenja.
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.
Slovenian: Klinična preskušanja so pokazala, da je zdravilo Seroquel pri shizofreniji in maniji učinkovito pri uporabi dvakrat na dan, čeprav je farmakokinetična razpolovna doba kvetiapina približno 7 ur.
English: In addition, for 25 mg tablets pack size of 6 tablets is registered.
Slovenian: Dodatno je za jakost 25 mg registrirano tudi pakiranje po 6 tablet.