FrancophonIA/ELRC3.0 huggingface dataset:
English: Doses greater than 300 mg should be initiated by physicians experienced in treating bipolar disorder.
Slovenian: Posameznim bolnikom lahko koristi odmerek 600 mg. Odmerke višje od 300 mg lahko uvede zdravnik, ki ima izkušnje z zdravljenjem bipolarne motnje.
English: AT - Austria AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien
Slovenian: AstraZeneca Österreich GmbH Schwarzenbergplatz 7
English: Skin and subcutaneous tissue disorders Very rare:
Slovenian: Bolezni kože in podkožja Zelo redki:
English: In elderly patients with major depressive episodes in MDD, dosing should begin with 50 mg/day on Days 1-3, increasing to 100 mg/day on Day 4 and 150 mg/day on Day 8.
Slovenian: Pri starejših bolnikih z velikimi depresivnimi epizodami, je treba odmerjanje začeti s 50 mg/dan od 1. do 3. dne, nato je treba odmerek povečati na 100 mg/dan 4. dan in na 150 mg/dan 8. dan.
English: Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine (see section 4.8).
Slovenian: Maligni nevroleptični sindrom je bil povezan z uporabo antipsihotičnih zdravil, vključno s kvetiapinom (glejte poglavje 4.8).
English: C/ Serrano Galvache, 56Edificio Roble 28033 Madrid Spain
Slovenian: C/ Serrano Galvache, 56 - Edificio Roble
English: The estimated risks of relapse after 6 months treatments was 14.3% for the Seroquel XR treatment group compared to 68.2% for placebo.
Slovenian: Ocenjeno tveganje recidiva po 6 mesecih zdravljenja je bilo 14,3 % v skupini, ki je dobivala zdravilo Seroquel SR, in 68,2 % v skupini, ki je dobivala placebo.
English: • treatment of bipolar disorder : o For the treatment of moderate to severe manic episodes in bipolar disorder o For the treatment of major depressive episodes in bipolar disorder o For the prevention of recurrence in patients with bipolar disorder, in patients whose manic or depressive episode has responded to quetiapine treatment .
Slovenian: • zdravljenje bipolarne motnje: o za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji o za zdravljenje depresivnih epizod bipolarne motnje o za preprečevanje ponavljanja epizod pri bipolarni motnji, pri bolnikih, katerih manične ali depresivne epizode so bile odzivne na zdravljenje s kvetiapinom
English: IS - Iceland AstraZeneca A/S Roskildevej 22
Slovenian: AstraZeneca A/S Roskildevej 22
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.
Slovenian: Poleg tega morajo zdravniki zaradi znanih dejavnikov tveganja pri zdravljeni bolezni upoštevati možno tveganje s samomorom povezanih dogodkov po nenadni prekinitvi zdravljenja s kvetiapinom.
English: In nearly all cases, cessation of Seroquel treatment was associated with a reversal of the effects on total and free T4, irrespective of the duration of treatment.
Slovenian: V skoraj vseh primerih je učinek na celotni in prosti T4 po prenehanju zdravljenja z zdravilom Seroquel izginil, ne glede na trajanje zdravljenja.
English: • Do not use Seroquel XR after the expiry date which is stated on the container after EXP.
Slovenian: • Zdravila Seroquel SR ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli za: »Uporabno do«.
English: WHAT SEROQUEL XR IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO SEROQUEL SR IN ZA KAJ GA UPORABLJAMO
English: Children and adolescents under 18 years Seroquel XR should not be used by children and adolescents aged under 18 years.
Slovenian: Otroci in mladostniki Zdravilo Seroquel SR se ne priporoča za bolnike mlajše od 18 let.
English: What Seroquel XR is and what it is used for Before you take Seroquel XR How to take Seroquel XR Possible side effects
Slovenian: Kaj je zdravilo Seroquel SR in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Seroquel SR Kako jemati zdravilo Seroquel SR Možni neželeni učinki
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.
Slovenian: Na splošno so bili opisani znaki in simptomi posledica pretiranih znanih farmakoloških učinkov zdravila, tj. zaspanost in sedacija, tahikardija in hipotenzija.
English: • Increase in the amount of a hormone called prolactin, in the blood.
Slovenian: • Povečanje količine hormona prolaktina v krvi.
English: In a long-term study in stable schizophrenic patients who had been maintained on Seroquel XR for 16 weeks, Seroquel XR was more effective than placebo in preventing relapse.
Slovenian: V dolgoročni študiji stabilnih bolnikov s shizofrenijo, vzdrževanih na terapiji z zdravilom Seroquel SR 16 tednov, je zdravilo Seroquel SR recidive preprečil učinkoviteje kot placebo.
English: The mean plasma clearance of quetiapine was reduced by approximately 25% in subjects with severe renal impairment (creatinine clearance less than 30 ml/min/1.73 m2), but the individual clearance values are within the range for normal subjects.
Slovenian: Pri bolnikih s hudo okvaro ledvic se je povprečni plazemski očistek kvetiapina zmanjšal za približno 25 % (očistek kreatinina manj kot 30 ml/min/1,73 m2 oziroma 0,5 ml/sek), toda individualne vrednosti očistka so bile znotraj območja za normalne osebe.
English: In the relapse prevention study (monotherapy), also in unrestricted MDD population but after 14 to 26 weeks of open label treatment, responders were randomised to continuing quetiapine treatment or placebo for up to 52 weeks and showed significant and clinically relevant results in favour of active treatment.
Slovenian: V študiji preprečevanja ponovnega pojava bolezni (monoterapiji), tudi v omejeni populaciji z velikimi depresivnimi motnjami, toda po 14 do 26 tednih odprtega zdravljenja, so bili odzivni pacienti naključno razdeljeni v skupini, ki sta do 52 tednov prejemali kvetiapin ali placebo, pri tem pa so kazali pomembne in klinično relevantne rezultate v korist aktivnega zdravljenja.
English: For the treatment of schizophrenia and moderate to severe manic episodes in bipolar disorder Seroquel XR should be administrated at least one hour before a meal.
Slovenian: Za zdravljenje shizofrenije in zmernih do hudih maničnih epizod pri bipolarni motnji Zdravilo Seroquel SR je treba uporabiti vsaj eno uro pred obrokom.
English: Children and adolescents (10 to 17 years of age) The same ADRs described above for adults should be considered for children and adolescents.
Slovenian: Otroci in mladostniki (stari od 10 do 17 let) Isti neželeni učinki, ki se pojavijo pri odraslih, se lahko pojavijo tudi pri otrocih in mladostnikih.
English: Increases in blood pressure were reported in children and adolescents and increased appetite, extrapyramidal symptoms and elevations in serum prolactin were reported with higher frequency in children and adolescents than in adult patients (see sections 4.4 and 4.8).
Slovenian: Pri otrocih in mladostnikih so bila opisana zvišanja krvnega tlaka; večji apetit, ekstrapiramidni simptomi in zvišanje prolaktina v serumu pa so bili pri otrocih in mladostnikih opisani pogosteje kot pri odraslih bolnikih (glejte poglavji 4.4 in 4.8).
English: As Seroquel XR is indicated for the treatment of schizophrenia, bipolar disorder and add-on treatment of major depressive episodes in patients with MDD, the safety profile should be considered with respect to the individual patient's diagnosis and the dose being administered.
Slovenian: Ker je zdravilo Seroquel SR indicirano za zdravljenje shizofrenije, bipolarne motnje in kot dodatno zdravljenje velikih depresivnih epizod pri bolnikih z veliko depresivno motnjo, je treba njegove varnostne značilnosti upoštevati glede na diagnozo posameznega bolnika in uporabljeni odmerek.
English: A slower titration regimen could be considered in patients with underlying cardiovascular disease.
Slovenian: Počasnejše titriranje odmerkov pride v poštev tudi pri bolnikih s srčno-žilnimi boleznimi.
English: Severe Neutropenia:
Slovenian: Huda nevtropenija:
English: Clinical safety
Slovenian: Klinična varnost:
English: In clinical trials and use in accordance with the SPC, quetiapine was not associated with a persistent increase in absolute QT intervals.
Slovenian: Kvetiapin v kliničnih preskušanjih in med uporabo v skladu s povzetkom glavnih značilnosti ni bil povezan z dolgotrajnim podaljšanjem absolutnih intervalov QT.
English: Please tell your doctor if you are taking or have recently taken any other medicines because it may affect the way the medicines work.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, vključno z zdravili, ki se dobijo brez recepta in zdravili naravnega izvora, ker lahko vplivajo na delovanje zdravila Seroquel SR.
English: Children and adolescents (10 to 17 years of age) Pharmacokinetic data were sampled in 9 children aged 10-12 years old and 12 adolescents, who were on steady-state treatment with 400 mg quetiapine (Seroquel) twice daily.
Slovenian: Farmakokinetični podatki so bili zbrani pri 9 otrocih, starih od 10 do 12 let, in pri 12 mladostnikih, ki so dobivali 400 mg kvetiapina (Seroquel) dvakrat na dan in so bili s tem zdravljenjem v stanju dinamičnega ravnovesja.
English: Seroquel XR was dosed in the range of 400 to 800 mg/day and the mean dose was approximately 600 mg/day.
Slovenian: Zdravilo Seroquel SR so uporabljali v odmerkih od 400 do 800 mg/dan in povprečni odmerek je bil približno 600 mg/dan.
English: • treatment of moderate to severe manic episodes in bipolar disorder.
Slovenian: • zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji;
English: - The CHMP concluded that the Product Information of quetiapine should reflect the current lack of long-term data of quetiapine as add-on treatment of major depressive episodes in patients with major depressive disorder, who have had suboptimal response to initial antidepressant mono-therapy and therefore recommended the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet.
Slovenian: - je CHMP zaključil, da morajo informacije o zdravilu za kvetiapin odražati trenutno odsotnost dolgoročnih podatkov za kvetiapin kot dodatnega zdravljenja velikih depresivnih epizod pri bolnikih z veliko depresivno motnjo, ki so imeli suboptimalen odziv na začetno antidepresivno monoterapijo, in je zato priporočil dopolnilo zadevnih delov povzetka glavnih značilnosti zdravila in navodila za uporabo.
English: The daily dose at the start of therapy is 50 mg on Day 1 and 2, and 150 mg on Day 3 and 4.
Slovenian: Dnevni odmerek na začetku zdravljenja je 50 mg 1. in 2. dan ter 150 mg 3. in 4. dan.
English: 10 prolonged-release tablets 30 prolonged-release tablets 50 prolonged-release tablets 60 prolonged-relaease tablets 100 prolonged-release tablets
Slovenian: 10 tablet s podaljšanim sproščanjem 30 tablet s podaljšanim sproščanjem 50 tablet s podaljšanim sproščanjem 60 tablet s podaljšanim sproščanjem 100 tablet s podaljšanim sproščanjem
English: Keep the Seroquel XR tablets with you.
Slovenian: S seboj vzemite Seroquel SR tablete.
English: • treatment of Schizophrenia, including o preventing relapse in stable schizophrenic patients who have been maintained on Seroquel XR.
Slovenian: • zdravljenje shizofrenije, vključno s preprečevanjem ponovnega pojava bolezni pri stabilnih shizofreničnih bolnikih, ki se jih vzdržuje z zdravilom Seroquel XR;
English: At steady-state, the dosenormalized plasma levels of the parent compound, quetiapine, in children and adolescents (10-17 years of age) were in general similar to adults, though Cmax in children was at the higher end of the range observed in adults.
Slovenian: Za odmerek normalizirana koncentracija matične spojine, kvetiapina, je bila v stanju dinamičnega ravnovesja pri otrocih in mladostnikih (starih od 10 do 17 let) na splošno podobna kot pri odraslih, toda Cmax je bila pri otrocih v zgornjem delu razpona, ugotovljenega pri odraslih.
English: If you take more Seroquel XR than you should If you take more Seroquel XR than prescribed by your doctor, you may feel sleepy, feel dizzy and experience abnormal heart beats.
Slovenian: Če ste vzeli večji odmerek zdravila Seroquel SR, kot bi smeli Če ste vzeli večji odmerek zdravila Seroquel SR, kot vam ga je predpisal vaš zdravnik, boste lahko zaspani, omotični ali se vam bo pojavilo nepravilno bitje srca.
English: Possible risk factors for neutropenia include pre-existing low white cell count (WBC) and history of drug induced neutropenia.
Slovenian: Med možnimi dejavniki tveganja za nevtropenijo sta že prisotno manjše število levkocitov in anamneza nevtropenije, izzvane z zdravili.
English: • Take your tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when.
Slovenian: • Ne jemljite tablet sočasno s hrano (vzemite jih vsaj eno uro pred obrokom ali pred spanjem.
English: In such an event, Seroquel XR should be discontinued and appropriate medical treatment given.
Slovenian: Če se pojavi, je treba zdravljenje z zdravilom Seroquel SR prekiniti in poskrbeti za ustrezno terapijo.
English: On 22 May 2009, the MAH triggered a referral under Article 6(13) of Commission Regulation (EC) No 1084/2003, requesting the CHMP to consider whether it is appropriate to introduce Seroquel XR, at 50 - 300 mg/day dosage to a population of patients with major depressive disorders, excluding the use as initial treatment and used when patients cannot be appropriately managed on alternative antidepressant treatment.
Slovenian: Dne 22. maja 2009 je imetnik dovoljenja za promet z zdravilom sprožil postopek napotitve v skladu s členom 6(13) Uredbe Komisije (ES) št. 1084/2003 in zahteval, da Odbor za zdravila za uporabo v humani medicini (CHMP) prouči, ali je primerno uporabljati zdravilo Seroquel XR v odmerku 50-300 mg/dan pri bolnikih z velikimi depresivnimi motnjami, brez uporabe kot začetno zdravljenje in z vključitvijo uporabe, kadar bolnikov ni možno ustrezno zdraviti z alternativnimi antidepresivi.
English: However in two 10-week placebo controlled quetiapine studies in the same patient population (n=710; mean age: 83 years; range: 56-99 years) the incidence of mortality in quetiapine treated patients was 5.5% versus 3.2% in the placebo group.
Slovenian: Toda v dveh 10tedenskih s placebom kontroliranih študijah kvetiapina pri isti populaciji bolnikov (n = 710, povprečna starost 83 let, razpon 56-99 let) je bila incidenca umrljivosti med prejemniki kvetiapina 5,5 % in v skupini s placebom 3,2 %.
English: Extrapyramidal symptoms3
Slovenian: ekstrapiramidni simptomi3
English: Long-term efficacy and safety in patients with MDD has not been evaluated as add-on therapy, however long-term efficacy and safety has been evaluated in adult patients as monotherapy (see below).
Slovenian: Dolgoročna učinkovitost in varnost pri bolnikih z veliko depresivno motnjo nista ocenjeni pri uporabo kot dodatno zdravilo, vendar pa sta bili dolgoročna učinkovitost in varnost ocenjeni pri odraslih bolnikih v monoterapiji (glejte spodaj).
English: In the schizophrenia study, the difference in LS mean change from baseline in PANSS total score (active minus placebo) was -8.16 for Seroquel 400 mg/day and -9.29 for Seroquel 800 mg/day .
Slovenian: V študiji shizofrenije je bila razlika v povprečni spremembi po metodi najmanjših kvadratov celotnega seštevka PANSS v primerjavi z izhodiščem (učinkovina minus placebo) -8,16 za Seroquel 400 mg/dan in -9,29 za Seroquel 800 mg/dan.
English: The CHMP concluded that there is potential benefit in the use of quetiapine as an add-on treatment of major depressive episodes in patients with MDD who have sub-optimal response to antidepressant monotherapy.
Slovenian: CHMP je zaključil, da obstaja morebitna korist uporabe kvetiapina kot dodatnega zdravljenja velikih depresivnih epizod pri bolnikih z MDD, ki imajo suboptimalen odziv na monoterapijo z antidepresivi.
English: Based on these in vitro results, it is unlikely that coadministration of quetiapine with other drugs will result in clinically significant drug inhibition of cytochrome P450 mediated metabolism of the other drug.
Slovenian: Na podlagi teh rezultatov in vitro ni verjetno, da bi sočasna uporaba kvetiapina z drugimi zdravili klinično pomembno zavirala presnovo drugih zdravil s citokromom P450.
English: Uncommon (affects less than 1 in 100 people):
Slovenian: Občasni neželeni učinki (pojavijo se pri manj kot 1 od 100 oseb):
English: Weight gain has been reported in patients who have been treated with quetiapine, and should be monitored and managed as clinically appropriate as in accordance with utilised antipsychotic guidelines (see Sections 4.8 and 5.1).
Slovenian: Zato je te bolnike treba kontrolirati in jih voditi, kot je klinično primerno in v skladu z uporabljanimi smernicami za antipsihotike (poglavji 4.8 in 5.1).
English: Quetiapine and norquetiapine also have high affinity at histaminergic and adrenergic α1 receptors, with a lower affinity at adrenergic α2- and serotonin 5HT1A receptors.
Slovenian: Kvetiapin in norkvetiapin imata tudi veliko afiniteto za histaminske receptorje in adrenergične receptorje α1, manjšo afiniteto pa za adrenergične receptorje α2.
English: In short-term, placebo-controlled clinical trials in schizophrenia and bipolar mania the aggregated incidence of extrapyramidal symptoms was similar to placebo (schizophrenia: 7.8% for quetiapine and 8.0% for placebo; bipolar mania: 11.2% for quetiapine and 11.4% for placebo).
Slovenian: V kratkotrajnih, s placebom kontroliranih kliničnih preskušanjih pri shizofreniji in bipolarni maniji je bila skupna incidenca ekstrapiramidnih simptomov podobna kot pri placebu (shizofrenija: 7,8 % s kvetiapinom, 8,0 % s placebom; bipolarna manija: 11,2 % s kvetiapinom in 11,4 % s placebom).
English: Efficacy Six studies in monotherapy and two add-on treatment studies were submitted by the MAH.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil šest študij monoterapije in dve študiji dopolnilnega zdravljenja.
English: 50 mg tablets are peach coloured; 150 mg tablets are white coloured, 200 mg tablets are yellow coloured; 300 mg tablets are pale yellow coloured and 400 mg tablets are white coloured.
Slovenian: 50 mg tablete so marelične barve, 150 mg tablete so bele barve, 200 mg tablete so rumene barve, 300 mg tablete so bledorumene barve, 400 mg tablete so bele barve.
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 undesirable effect (EPS) liability of Seroquel compared to typical antispychotics.
Slovenian: Domnevno ta kombinacija antagonističnega delovanja na receptorje in večja selektivnost za receptorje 5HT2 v primerjavi z receptorji D2 prispeva h kliničnim antipsihotičnim lastnostim zdravila Seroquel in majhni nagnjenosti k ekstrapiramidnim neželenim učinkom (EPU).
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.
Slovenian: Incidenca posameznih neželenih dogodkov pri bipolarni depresiji in MDD (npr. akatizije, ekstrapiramidne motnje, tremorja, diskinezije, distonije, nemira, nehotnega krčenja mišic, psihomotorične hiperaktivnosti in togosti mišic) v nobeni terapevtski skupini ni presegla 4 %.
English: Concomitant administration of cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin and nefazodone, is contraindicated.
Slovenian: Sočasna uporaba zaviralcev citokroma P450 3A4, npr. zaviralcev proteaz HIV, azolskih antimikotikov, eritromicina, klaritromicina in nefazodona je kontraindicirana (glejte poglavje 4.5).
English: • treatment of schizophrenia including preventing relapses in stable schizophrenic patients who have been maintained on Seroquel XR.
Slovenian: • zdravljenje shizofrenije, vključno s o preprečevanjem relapsa pri shizofrenih bolnikih v stabilni remisiji, ki so na vzdrževalnem zdravljenju z zdravilom Seroquel SR
English: Seizure 1, Restless legs syndrome, Tardive dyskinesia 1, 6
Slovenian: konvulzije1, sindrom nemirnih nog, zapoznela diskinezija
English: In patients receiving a hepatic enzyme inducer, initiation of Seroquel XR treatment should only occur if the physician considers that the benefits of Seroquel XR outweigh the risks of removing the hepatic enzyme inducer.
Slovenian: Pri bolnikih, ki dobivajo induktor jetrnih encimov, naj bi zdravljenje z zdravilom Seroquel SR uvedli le, če koristi terapije z zdravilom Seroquel SR po zdravnikovi presoji odtehtajo tveganja zaradi opustitve induktorja jetrnih encimov.
English: • Do not split, chew or crush the tablets.
Slovenian: • Tablet ne lomite, ne žvečite in ne drobite.
English: If you are, Seroquel XR should not be taken because the group of medicines that Seroquel XR belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
Slovenian: Če ste, ne smete jemati zdravila Seroquel SR, kajti skupina zdravil, v katero spada Seroquel SR, lahko starejšim osebam z demenco poveča tveganje možganske kapi in v nekaterih primerih tveganje smrti,imate vi ali kdo v vaši družini zgodovino nastanka krvnih strdkov, saj so ta zdravila povezana z nastankom krvnih strdkov.
English: Not all pack sizes may be marketed.
Slovenian: Vseh navedenih pakiranj ni na trgu.
English: • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
Slovenian: • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”).
Slovenian: Zdravniku morate nemudoma povedati, če se vam pojavijo: zvišana telesna temperatura, huda togost mišic, znojenje ali poslabšanje zavesti (to je motnja, ki jo imenujemo “maligni nevroleptični sindrom”).
English: Seroquel XR 150 mg and 300 mg/day, given as add-on treatment to ongoing antidepressant therapy (amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline or venlafaxine) demonstrated superiority over antidepressant therapy alone in reducing depressive symptoms as measured by improvement in MADRS total score (LS mean change vs. placebo of 2-3.3 points).
Slovenian: Seroquel SR 150 mg in 300 mg/dan kot dodatek že potekajočemu antidepresivnemu zdravljenju (amitriptilin, bupropion, citalopram, duloksetin, escitalopram, fluoksetin, paroksetin, sertralin ali venlafaksin) je v primerjavi z antidepresivno terapijo samo superiorno zmanjšal depresivne simptome; kot merilo je bilo uporabljeno izboljšanje celotnega seštevka po MADRS (povprečna sprememba po metodi najmanjših kvadratov 2 do 3,3 točke v primerjavi s placebom).
English: Elevations in blood creatine phosphokinase15
Slovenian: zvišane vrednosti kreatin-fosfokinaze
English: It is important that any change in the inducer is gradual, and if required, replaced with a non-inducer (e.g. sodium valproate) (see section 4.4).
Slovenian: Če je potrebno, ga je treba nadomestiti z neinduktorjem (npr. natrijevim valproatom) (glejte poglavje 4.4).
English: In short-term clinical trials with Seroquel in paediatric patients (10-17 years of age), 17% of quetiapine treated patients and 2.5% of placebo treated patients gained ≥7% of their body weight.
Slovenian: V kratkotrajnih kliničnih preskušanjih zdravila Seroquel pri pediatričnih bolnikih (starih od 10 do 17 let) se je telesna masa povečala za ≥ 7 % pri 17 % bolnikov, zdravljenih s kvetiapinom, in pri 2,5 % bolnikov, ki so dobivali placebo.
English: In a long-term open label study with Seroquel of schizophrenia and bipolar mania, the aggregated incidence of treatment-emergent EPS was 10%.
Slovenian: Med dolgotrajno odprto študijo Seroquela pri shizofreniji in bipolarni maniji je bila skupna incidenca med zdravljenjem nastalih ekstrapiramidnih simptomov 10 %.