natgillin/translations-raw huggingface dataset:
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.
Na splošno so bili opisani znaki in simptomi posledica pretiranih znanih farmakoloških učinkov zdravilne učinkovine, tj. zaspanost in sedacija, tahikardija in hipotenzija.
For maintenance therapy in schizophrenia no dosage adjustment is necessary.
Za vzdrževalno zdravljenje shizofrenije odmerka ni treba spreminjati.
It is this combination of receptor antagonism with a higher selectivity for 5HT2 relative to D2- receptors, which is believed to contribute to the clinical antipsychotic properties and low extrapyramidal side effect (EPS) liability of Seroquel compared to typical antispychotics.
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) v primerjavi s tipičnimi antipsihotiki.
These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
Med takšnimi so težave z začenjanjem mišičnih gibov, tresenje, občutek nemira ali togost mišic, ki je ne spremljajo bolečine.
These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in your blood, increased liver enzymes, decreases in the number of certain types of blood cells, decrease in the amount of red blood cells, increased blood creatine phosphokinase (a substance in the muscles), decrease in the amount of sodium in the blood and increases in the amount of the hormone prolactin in the blood.
Vključno s spremembami določenih maščob (trigliceridov ali celokupnega holesterola), sladkorja v krvi, spremembami v koncentraciji ščitničnih hormonov v krvi, zvišanjem jetrnih encimov, zmanjšanjem števila določenih vrst krvnih celic, zmanjšanjem števila rdečih krvnih celic, zvišanjem kreatin-fosfokinaze (snov v mišicah) v krvi, znižanjem koncentracije natrija v krvi in zvišanjem koncentracije hormona imenovanega prolaktin v krvi.
As Seroquel has several indications, the safety profile should be considered with respect to the individual patient's diagnosis and the dose being administered.
Ker ima zdravilo Seroquel več indikacij, je treba varnostne značilnosti obravnavati glede na diagnozo posameznega bolnika in uporabljeni odmerek.
Based on public literature, patients with delerium and agitation and a clear anticholinergic syndrome may be treated with physostigmine, 1-2 mg (under continuous ECG monitoring).
Na podlagi objavljene literature se lahko bolnike z delirijem ali agitiranostjo in čistim antiholinergičnim sindromom, zdravi z uporabo fizostigmina 1-2 mg (med stalno kontrolo EKG).
PHARMACEUTICAL FORM AND CONTENTS 8 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 8 filmsko obloženih tablet kombinirano pakiranje
Cases of QT prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and torsades de pointes have been reported with the use of neuroleptics and are considered class effects.
Primeri podaljšanja QT intervala, ventrikularne aritmije, nenadne nepojasnjene smrti, kardialnega aresta in 'torsades de pointes' so bili poročani pri uporabi nevroleptikov in se vrednotijo kot razredni učinek.
• Dizziness (may lead to falls), headache, dry mouth.
• omotica (lahko povzroči padce), glavobol, suha usta,
Elderly patients with dementia-related psychosis Quetiapine is not approved for the treatment of dementia-related psychosis.
Starejši bolniki s psihozo, povezano z demenco Kvetiapin ni odobren za zdravljenje bolnikov s psihozo, povezano z demenco.
As quetiapine is extensively metabolised by the liver, elevated plasma levels are expected in the population with hepatic impairment.
Ker se kvetiapin izdatno presnovi v jetrih, je mogoče v populaciji z okvaro jeter pričakovati zvišano koncentracijo v plazmi.
Constipation along with persistent abdominal pain, or constipation which has not responded to treatment, as this may lead to a more serious blockage of the bowel.
• zaprtost in dolgotrajne bolečine v trebuhu, ali zaprtost, ki se ne odzove na zdravljenje; to namreč lahko povzroči resnejšo zaporo črevesa.
• Fainting (may lead to falls)
• omedlevica (lahko povzroči padce),
For 150 mg and 300 mg tablets pack sizes of 120, 180 and 240 tablets are registered.
Za jakosti 150 mg in 300 mg so registrirana tudi pakiranja po 120, 180 in 240 tablet.
In clinical studies of patients with MDD the incidence of suicide-related events observed in young adult patients (younger than 25 years of age) was 2.1% (3/144) for quetiapine and 1.3% (1/75) for placebo.
V kliničnih študijah bolnikov z depresijo (MDD) je bila incidenca s samomorom povezanih dogodkov, zabeleženih med mladimi odraslimi bolniki (mlajšimi od 25 let) 2,1 % (3/144) s kvetiapinom in 1,3 % (1/75) s placebom.
Side effects in children and adolescents The same side effects that may occur in adults may also occur in children and adolescents.
Neželeni učinki pri otrocih in mladostnikih Enaki neželeni učinki, ki se pojavijo pri odraslih, se lahko pojavijo tudi pri otrocih in mladostnikih.
• Swallow your tablets whole with a drink of water.
• Tablete zaužijte cele z vodo.
4-Day Starterpack
4-dnevno začetno pakiranje
Gender The kinetics of quetiapine do not differ between men and women.
Kinetika kvetiapina se med moškimi in ženskami ne razlikuje.
Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with quetiapine and preventive measures undertaken.
Ker so pri bolnikih zdravljenih z antipsihotiki pogosto prisotni dejavniki tveganja za vensko tromboembolijo, je potrebno opredeliti vse dejavnike tveganja za vensko tromboembolijo pred in med zdravljenjem s kvetiapinom, izvedejo pa naj se ustrezni preventivni ukrepi.
Norquetiapine is primarily formed and eliminated via CYP3A4.
Norkvetiapin v prvi vrsti nastaja in se odstranjuje s CYP3A4
(2) Somnolence may occur, usually during the first two weeks of treatment and generally resolves with the continued administration of quetiapine.
(2) Pojavi se lahko zaspanost, ponavadi v prvih dveh tednih zdravljenja, ki med nadaljnjo uporabo kvetiapina praviloma mine.
In an embryofetal toxicity study in rabbits the foetal incidence of carpal/tarsal flexure was increased.
V študiji embrio-fetalne toksičnosti pri kuncih se je povečala incidenca karpalne/tarzalne fleksure pri plodovih.
120 film-coated tablets (150 mg and 300 mg tablets only) 180 film-coated tablets (150 mg and 300 mg tablets only) 240 film-coated tablets (150 mg and 300 mg tablets only)
120 filmsko obloženih tablet (samo 150 mg in 300 mg tablete) 180 filmsko obloženih tablet (samo 150 mg in 300 mg tablete) 240 filmsko obloženih tablet (samo 150 mg in 300 mg tablete)
In patients receiving a hepatic enzyme inducer, initiation of quetiapine treatment should only occur if the physician considers that the benefits of quetiapine outweigh the risks of removing the hepatic enzyme inducer.
Pri bolnikih, ki prejemajo induktor jetrnih encimov, lahko zdravljenje s kvetiapinom uvedemo le, če zdravnik oceni, da so koristi zdravljenja s kvetiapinom večje kot tveganja pri prekinitvi zdravljenja z induktorjem jetrnih encimov.
• Abnormal muscle movements.
• nenormalni gibi mišic.
The lowest effective dose, starting from 50 mg/day should be used.
Uporabiti je treba najmanjši učinkoviti odmerek, začenši s 50 mg/dan.
The pharmacokinetics of quetiapine and norquetiapine are linear across the approved dosing range.
Farmakokinetika kvetiapina in norkvetiapina je v odobrenem razponu odmerkov linearna.
Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine (see section 4.8).
Pojav nevroleptičnega malignega sindroma povezujejo z antipsihotičnim zdravljenjem, vključno s kvetiapinom (glejte poglavje 4.8).
You should not take Seroquel XR during pregnancy unless this has been discussed with your doctor.
Ne jemljite zdravila Seroquel SR med nosečnostjo, razen če se o tem niste pogovorili s svojim zdravnikom.
The mean last week median dose of Seroquel in responders was approximately 600 mg/day and approximately 85% of the responders were in the dose range of 400 to 800 mg/day.
Povprečna mediana odmerka zdravila Seroquel v zadnjem tednu pri bolnikih, ki so se na zdravilo odzivali, je bila približno 600 mg/dan, približno 85 % teh bolnikov pa je bilo v območju odmerkov med 400 in 800 mg/dan.
Angioedema StevensJohnson syndrome5
Bolezni kože in podkožja angioedem StevensJohnsonov sindrom5
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.
Poleg tega morajo zdravniki, zaradi znanih dejavnikov tveganja pri zdravljeni bolezni, upoštevati možno tveganje s samomorom povezanih dogodkov po nenadni prekinitvi zdravljenja s kvetiapinom.
Neonates exposed to antipsychotics (including quetiapine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Pri novorojenčkih, ki so bili v tretjem trimesečju nosečnosti izpostavljeni antipsihotikom (tudi kvetiapinu) se lahko pojavijo neželeni učinki, vključno z ekstrapiramidnimi in/ali odtegnitvenimi simptomi, ki se lahko razlikujejo glede na resnost in trajanje po porodu.
In vitro CYP inhibition is observed only at concentrations approximately 5 to 50 fold higher than those observed at a dose range of 300 to 800 mg/day in humans.
In vitro je zavrtje CYP opazno le v koncentracijah, ki so približno 5- do 50-krat višje od koncentracij pri človeku, če je zdravilo uporabljeno v odmerkih od 300 do 800 mg/dan.
PHARMACEUTICAL FORM AND CONTENTS 10 prolonged-release tablets
FARMACEVTSKA OBLIKA IN VSEBINA 10 tablet s podaljšanim sproščanjem
(29) Based on adverse event reports of metabolic syndrome from all clinical trials with quetiapine.
(29) Na podlagi poročil o neželenih učinkih metabolnega sindroma iz vseh kliničnih raziskav s kvetiapinom.
Acute withdrawal symptoms such as insomnia, nausea, headache, diarrhoea, vomiting, dizziness, and irritability have been described after abrupt cessation of quetiapine.
Akutni odtegnitveni simptomi kot so nespečnost, slabost, glavobol, diareja, bruhanje, omotica in razdražljivost so bili opisani po takojšnjem prenehanju zdravljenja s kvetiapinom.
The following symptoms which can represent withdrawal may occur in newborn babies of mothers that have used Seroquel in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Naslednji simptomi, ki lahko predstavljajo odtegnitev, se lahko pojavijo pri novorojenčkih mater, ki so uporabljale zdravilo Seroquel v zadnjem trimesečju (zadnje tri mesece nosečnosti): tresenje, togost mišic in/ali oslabelost, zaspanost, nemir, težave z dihanjem in težave pri hranjenju.
If you are pregnant or breast feeding, think you may be pregnant or planning to have a baby ask your doctor for advice before taking Seroquel.
Če ste noseči ali dojite, menite da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Pack sizes of 10, 30, 50, 60 and 100 tablets are registered for all strengths.
Velikosti pakiranj po 10, 30, 50, 60 in 100 tablet so registrirane za vse jakosti.
In clinical trials, no additional benefit was seen in the 600 mg group compared to the 300 mg group (see section 5.1).
V kliničnih raziskavah pri skupini bolnikov, ki so prejemali odmerek 600 mg, niso zaznali dodatne koristi v primerjavi s skupino bolnikov, ki so prejemali odmerek 300 mg (glejte poglavje 5.1).
In a multiple dose trial in patients to assess the pharmacokinetics of quetiapine given before and during treatment with carbamazepine (a known hepatic enzyme inducer), co-administration of carbamazepine significantly increased the clearance of quetiapine.
V preskušanjih s ponavljajočimi odmerki za oceno farmakokinetike kvetiapina, uporabljenega pred in med zdravljenjem s karbamazepinom (znan induktor jetrnih encimov), so pri bolnikih ugotovili, da sočasna uporaba karbamazepina pomembno zviša očistek kvetiapina.
You may find that you feel depressed, feel guilty, lack energy, lose your appetite or can't sleep.
• bipolarne depresije: ko se lahko počutite žalostne ali depresivne, krive, brez energije, izgubite apetit ali ne morete spati.
Pack sizes of 20, 30, 50, 60 and 100 tablets are registered for all strengths.
Velikosti pakiranj po 20, 30, 50, 60 in 100 tablet so registrirane za vse jakosti.
Distribution Quetiapine is approximately 83% bound to plasma proteins.
Porazdelitev Približno 83% kvetiapina se veže na beljakovine v plazmi.
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.
Kvetiapin in več njegovih presnovkov (vključno z norkvetiapinom) in vitro rahlo zavirajo delovanje encimov 1A2, 2C9, 2C19, 2D6 in 3A4 humanega citokroma P450.
In a monotherapy relapse prevention study, patients with depressive episodes stabilised on open-label Seroquel XR treatment for at least 12 weeks were randomised to either Seroquel XR once daily or placebo for up to 52 weeks.
V študiji preprečevanja recidivov z monoterapijo so bolnike z obdobji depresije vsaj 12 tednov stabilizirane v odprti fazi zdravljenja z zdravilom Seroquel SR, randomizirali na Seroquel SR enkrat na dan ali na placebo za obdobje do 52 tednov.
Seroquel XR can be used to treat several illnesses, such as:
Zdravilo Seroquel SR se lahko uporablja za zdravljenje več bolezni, npr.:
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).
Pomembno je, da je vsaka sprememba v zdravljenju z induktorjem postopna, in če je treba, lahko induktor nadomestimo z zdravilom, ki ne inducira jetrnih encimov (npr. natrijevim valproatom) (glejte poglavje 4.4).
Rhinitis
rinitis
The incidences of shifts in TSH was 3.2 % for quetiapine versus 2.7 % for placebo.
Incidenca sprememb TSH je bila 3,2 % s kvetiapinom in 2,7 % s placebom.
In a specific interaction study in psychotic patients, however, no increase in the cytochrome P450 activity was found after administration of quetiapine.
Toda v specifični študiji medsebojnega delovanja pri psihotičnih bolnikih po uporabi kvetiapina niso ugotovili večje aktivnosti citokroma P450.
Elevations in blood creatine phosphokinase
Preiskave zvišanje kreatinfosfokinaze v krvi
Due to lack of robust data, a decision must be made whether to discontinue breast-feeding or to discontinue Seroquel therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Zaradi pomanjkanja zanesljivih podatkov se je treba odločiti bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Seroquel, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
• A long-lasting and painful erection (priapism).
• dolgotrajna ali boleča erekcija (priapizem).
Quetiapine treatment has been associated with orthostatic hypotension and related dizziness (see Section 4.8) which, like somnolence has onset usually during the initial dose-titration period.
Zdravljenje s kvetiapinom je bilo povezano z ortostatsko hipotenzijo in spremljajočo omotico (glejte poglavje 4.8), ki se po navadi pojavi med uvodnim obdobjem prilagajanja odmerka, tako kot zaspanost.
• You have low blood pressure.
• nizek krvni tlak stoje.
Quetiapine should be used with caution in patients at risk for aspiration pneumonia.
Kvetiapin je treba uporabljati previdno pri bolnikih z večjim tveganjem za aspiracijsko pljučnico.
In patients stabilised on Seroquel immediate release 400 mg to 800 mg, efficacy was maintained when patients were switched to an equivalent daily dose of Seroquel XR given once daily.
Pri bolnikih, stabiliziranih na 400 do 800 mg zdravila Seroquel, se je učinkovitost ohranila, ko so prešli na enak dnevni odmerek zdravila Seroquel SR enkrat na dan.
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.
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), toda individualne vrednosti očistka so bile znotraj območja za normalne osebe.
Co-administration of quetiapine and phenytoin (another microsomal enzyme inducer) caused a greatly increased clearance of quetiapine by approx. 450%.
Sočasno zdravljenje s kvetiapinom in fenitoinom (induktor mikrosomalnih encimov) povzroči izrazito povečanje očistka kvetiapina za približno 450 %.
Abnormal dreams and nightmares, Suicidal ideation and suicidal behaviour
Psihiatrične motnje nenormalne sanje in nočne more, samomorilno razmišljanje in samomorilno vedenje20
• Fits (seizures).
• napadi krčev (konvulzije).
On the basis of this, concomitant use of quetiapine with CYP3A4 inhibitors is contraindicated.
Sočasna uporaba kvetiapina z zaviralci CYP3A4 je zato kontraindicirana.
As Seroquel XR has several indications, the safety profile should be considered with respect to the individual patient's diagnosis and the dose being administered.
Ker ima zdravilo Seroquel SR več indikacij, je treba varnostne značilnosti obravnavati glede na diagnozo posameznega bolnika in uporabljeni odmerek.
Neuroleptic Malignant Syndrome:
Nevroleptični maligni sindrom:
Gender: The pharmacokinetics of quetiapine does not differ between men and women.
Farmakokinetika kvetiapina se med moškimi in ženskami ne razlikuje.
6 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
6 filmsko obloženih tablet 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet
Due to lack of robust data, a decision must be made whether to discontinue breast-feeding or to discontinue Seroquel XR therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Zaradi pomanjkanja zanesljivih podatkov se je treba odločiti bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Seroquel SR, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
Before you stop taking any of your medicines, please talk to your doctor first.
Preden nehate jemati katerokoli zdravilo, se morate posvetovati z zdravnikom.
Table 2 ADRs in children and adolescents associated with quetiapine therapy that occur in a higher frequency than adults, or not identified in the adult population
Preglednica 2 Neželeni učinki pri otrocih in mladostnikih, povezani z zdravljenjem s kvetiapinom in ki se pojavljajo z večjo pogostnostjo kot pri odraslih ali pri odraslih niso bili ugotovljeni
Constipation represents a risk factor for intestinal obstruction.
Zaprtost predstavlja dejavnik tveganja za zaporo črevesa.
In clinical trials for treatment of patients with bipolar depression and major depressive disorder, onset was usually within the first 3 days of treatment and was predominantly of mild to moderate intensity.
V kliničnih preskušanjih za zdravljenje bolnikov z bipolarno depresijo in veliko depresivno motnjo so se ponavadi pojavili v prvih 3 dneh zdravljenja in so bili pretežno blagi do zmerni.
In patients who responded to quetiapine, when comparing continued treatment with quetiapine to switching to lithium, the results indicated that a switch to lithium treatment does not appear to be associated with an increased time to recurrence of a mood event.
Pri bolnikih, ki so se odzvali na akutno zdravljenje s kvetiapinom, rezultati primerjave nadaljevalnega zdravljenja s kvetiapinom in prehoda na litij kažejo, da prehod na litij ni povezan s podaljšanjem časa do naslednjega recidiva motnje razpoloženja.
There was no evidence of genotoxicity in a series of in vitro and in vivo genotoxicity studies.
V vrsti študij genotoksičnosti in vitro in in vivo niso ugotovili genotoksičnih učinkov.
in elderly patients.
Starejši bolniki:
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 Section 5.1).
Dolgoročna učinkovitost in varnost pri bolnikih z veliko depresivno motnjo (MDD) nista ocenjeni v primeru, ko se uporabi kot dodatno zdravilo, vendar pa sta bili dolgoročna učinkovitost in varnost ocenjeni pri odraslih bolnikih v monoterapiji (glejte poglavje 5.1).
A retrospective study of children and adolescents who received valproate, quetiapine, or both, found a higher incidence of leucopenia and neutropenia in the combination group versus the monotherapy groups.
Retrospektivna študija otrok in mladostnikov, ki so prejemali valproat, kvetiapin ali oba, je ugotovila večjo incidenco levkopenije in nevtropenije v skupini, ki je prejemala kombinirano zdravljenje, kot v skupinah, ki sta prejemali monoterapijo.
The mean clearance of quetiapine in the elderly is approximately 30 to 50% lower than that seen in adults aged 18 to 65 years.
Pri starejših bolnikih je povprečni očistek kvetiapina za približno 30 do 50 % manjši kot pri odraslih bolnikih, starih od 18 do 65 let.
Dose reduction or more gradual titration should be considered if orthostatic hypotension occurs, especially in patients with underlying cardiovascular disease.
Če se pojavi ortostatska hipotenzija, pride v poštev zmanjšanje odmerka ali postopnejše titriranje, zlasti pri bolnikih s srčno žilnimi boleznimi.
The safety results showed a higher incidence of extrapyramidal symptoms reported in 16.8% of patients in the lithium add-on group and 6.6% in the placebo add-on group, the majority of which consisted of tremor, reported in 15.6% of the patients in the lithium add-on group and 4.9% in the placebo add-on group.
Rezultati o varnosti so pokazali večjo incidenco ekstrapiramidnih simptomov v skupini z dodatkom litija (16,8 %) kot v skupini z dodatkom placeba (6,6 %); večinoma je šlo za tremor opažali so ga pri 15,6 % bolnikov v skupini z dodatkom litija in pri 4,9 % bolnikov v skupini z dodatkom placeba.
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).
Dolgoročna učinkovitost in varnost pri bolnikih z veliko depresivno motnjo nista ocenjeni pri uporabi kot dodatno zdravilo, vendar pa sta bili dolgoročna učinkovitost in varnost ocenjeni pri odraslih bolnikih v monoterapiji (glejte spodaj).
Keep the Seroquel tablets with you.
S seboj vzemite tablete zdravila Seroquel.
Do not take Seroquel if you are taking any of the following medicines:
Ne jemljite zdravila Seroquel, če jemljete katero od naštetih zdravil:
• Feeling irritated.
• občutek razdražljivosti.
Clinical trials with quetiapine have shown that in addition to the known safety profile identified in adults (see section 4.8), certain adverse events occurred at a higher frequency in children and adolescents compared to adults (increased appetite, elevations in serum prolactin, vomiting, rhinitis and syncope), or may have different implications for children and adolescents (extrapyramidal symptoms and irritability) and one was identified that has not been previously seen in adult studies (increases in blood pressure).
Klinična preskušanja s kvetiapinom so pokazala, da so poleg znanih varnostnih značilnosti, ugotovljenih pri odraslih (glejte poglavje 4.8), nekateri neželeni učinki pri otrocih in mladostnikih pogostejši kot pri odraslih (večji apetit, zvišanje prolaktina v serumu, bruhanje, rinitis in sinkopa), ali pa imajo lahko za otroke in mladostnike drugačne implikacije (ekstrapiramidni simptomi in razdražljivost).