natgillin/translations-raw huggingface dataset:
Seroquel XR is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group.
Zdravila Seroquel SR ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker ni podatkov, ki bi podpirali njegovo uporabo v tej starostni skupini.
Tablet core : povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycollate Type A, lactose monohydrate, magnesium stearate Tablet coating: hypromellose, macrogol, titanium dioxide (E171).
Jedro tablete: povidon, kalcijev hidrogenfosfat dihidrat, mikrokristalna celuloza (E 460), natrijev karboksimetilškrob (vrsta A), laktoza monohidrat, magnezijev stearat (E 572).
Carton (pack) contents
Vsebina škatle (pakiranja)
Increases in blood pressure2
Žilne bolezni zvišanje krvnega tlaka2
Seroquel tablets contain 25 mg, 100 mg, 150 mg, 200 mg or
Tablete zdravila Seroquel vsebujejo 25 mg, 100 mg, 150 mg
The frequencies of adverse events are ranked according to the following: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100, rare (≥1/10,000, <1/1000), very rare (<1/10,000), and not known
Pogostnost neželenih učinkov je opredeljena kot sledi: zelo pogosti (> 1/10), pogosti (> 1/100 do < 1/10), občasni (> 1/1.000 do < 1/100), redki (> 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg (or 150 mg, or 200 mg or 300 mg) quetiapine (as fumarate)
Ena tableta vsebuje 100 mg (ali 150 mg ali 200 mg ali 300 mg) kvetiapina (v obliki fumarata).
Respiratory, thoracic and mediastinal disorder
Bolezni dihal, prsnega koša in mediastinalnega prostora rinitis
Hypromellose 2910
hipotiroidize m21
Priapism, galactorrhoea, breast swelling, menstrual disorder
Motnje reprodukcije in dojk spolna disfunkcija priapizem, galaktoreja, oteklost dojk, menstruacijske motnje
For add-on treatment of major depressive episodes in MDD:
Kot dodatno zdravljenje velikih depresivnih epizod pri veliki depresivni motnji
Weight gain
zvišanje gama
Talk to your doctor or pharmacist before taking Seroquel XR if:
Pred začetkom jemanja zdravila Seroquel SR se posvetujte z zdravnikom ali farmacevtom če:
As with other antipsychotics, Seroquel should be used with caution in the elderly, especially during the initial dosing period.
Starejši bolniki: Tako kot druge antipsihotike, moramo tudi zdravilo Seroquel pri starejših bolnikih uporabljati previdno, zlasti v začetnem obdobju odmerjanja zdravila.
• Shortness of breath.
• hitro bitje srca,
4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients of this product.
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Contents of the pack and other information
Shranjevanje zdravila Seroquel Vsebina pakiranja in dodatne informacije
Rare side effects (may affect up to 1 in 1,000 people):
Redki neželeni učinki: pojavijo se lahko pri največ 1 od 1.000 bolnikov
Pharmacodynamic effects:
Farmakodinamični učinki
18 blisters of 10 tablets (150 mg and 300 mg tablets only)
18 pretisnih omotov po 10 tablet (samo 150 mg in 300 mg tablete)
24 blisters of 10 tablets (150 mg and 300 mg tablets only)
24 pretisnih omotov po 10 tablet (samo 150 mg in 300 mg tablete)
Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events).
samopoškodovanja in samomorilnosti (s samomorom povezani dogodki).
Women to have no monthly period or irregular periods.
o izostanek menstruacij ali neredne menstruacije pri ženskah.
Uncommon side effects (may affect up to 1 in 100 people):
Občasni neželeni učinki: pojavijo se lahko pri največ 1 od 100 bolnikov
Seroquel 25 mg film-coated tablets Seroquel 100 mg film-coated tablets Seroquel 150 mg film-coated tablets Seroquel 200 mg film-coated tablets Seroquel 300 mg film-coated tablets Seroquel 3-Day Starterpack (Combined pack) Seroquel 4-Day Starterpack
Seroquel 25 mg filmsko obložene tablete Seroquel 100 mg filmsko obložene tablete Seroquel 150 mg filmsko obložene tablete Seroquel 200 mg filmsko obložene tablete Seroquel 300 mg filmsko obložene tablete
Very rare side effects (may affect up to 1 in 10,000 people):
Zelo redki neželeni učinki: pojavijo se lahko pri največ 1 od 10.000 bolnikov
100 film-coated tablets
100 filmsko obloženih tablet
(≥1/100, <1/10), uncommon (≥1/1000, <1/100, rare (≥1/10,000, <1/1000), very rare (<1/10,000), and not known
1/10), občasni (> 1/1000 do < 1/100), redki (> 1/10.000 do < 1/1000) in zelo redki (< 1/10.000).
What you need to know before you take Seroquel
Kaj morate vedeti, preden boste vzeli zdravilo Seroquel Ne jemljite zdravila Seroquel
(24) Based on shifts from normal baseline to potentially clinically important value at anytime post-baseline in all trials.
(24) Na podlagi sprememb od normalne izhodiščne do potencialno klinično pomembne vrednosti kadarkoli po izhodišču v vseh preskušanjih.
Thrombocytope nia, Anaemia, platelet count decreased
trombocitopen ija, anemija, zmanjšano število trombocitov13
For preventing recurrence of manic, mixed or depressive episodes in bipolar disorder, patients who have responded to Seroquel XR for acute treatment of bipolar disorder should continue on Seroquel XR at the same dose administered at bedtime.
Pri bolnikih, ki so se odzvali na akutno zdravljenje bipolarne motnje z zdravilom Seroquel SR za preprečevanje recidivov maničnih, depresivnih ali mešanih epizod je priporočljivo zdravljenje nadaljevati z enakim odmerkom zdravila Seroquel SR pred spanjem.
50 prolonged-release tablets
50 tablet s podaljšanim sproščanjem
Third trimester
Tretje trimesečje
NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg film-coated tablets quetiapine
IME ZDRAVILA Seroquel 25 mg filmsko obložene tablete kvetiapin
NAME OF THE MEDICINAL PRODUCT Seroquel 100 (or 150 mg, or 200 mg or 300 mg) mg film-coated tablets quetiapine
Seroquel 100 mg (ali 150 mg ali 200 mg ali 300 mg) filmsko obložene tablete kvetiapin
For the treatment of major depressive episodes in bipolar disorder Seroquel should be administered once daily at bedtime.
Za zdravljenje depresivnih epizod pri bipolarni motnji Zdravilo Seroquel se jemlje 1x dnevno pred spanjem.
Platelets ≤100 x 109/L on at least one occasion 14.
(13) Število trombocitov ob enkratni priložnosti ≤100 x 109/L.
Prolactin levels (patients>18 years of age): >20 µg/L (>869.56 pmol/L) males; >30 µg/L (>1304.34 pmol/L) females at any time 16.
(15) Koncentracija prolaktina (bolniki v starosti ≥ 18 let): > 20 µg/l moški (>869.56 pmol/L), > 30 µg/l
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.
16 tednov, je zdravilo Seroquel SR recidive preprečil učinkoviteje kot placebo.
For preventing recurrence of manic, mixed or depressive episodes in bipolar disorder, patients who have responded to quetiapine for acute treatment of bipolar disorder should continue therapy at the same dose.
Pri bolnikih, ki so se odzvali na akutno zdravljenje bipolarne motnje s kvetiapinom, je priporočljivo za preprečevanje recidivov maničnih, depresivnih ali mešanih epizod pri bipolarni motnji terapijo nadaljevati z enakim odmerkom.
Inhibition of NET and partial agonist action at 5HT1A sites by norquetiapine may contribute to Seroquel's therapeutic efficacy as an antidepressant.
K terapevski antidepresivni učinkovitosti zdravila Seroquel morda pripomore norkvetiapin z zavrtjem NET in delnim agonističnim delovanjem na mestih 5HT1A.
1 blister of 10 tablets
1 pretisni omot po 10 tablet
Elevations in serum alanine aminotransferas e (ALT)
žolčnika in žolčevodov zvišanje alaninaminotransferaz e (ALT) v serumu3,
Inhibition of NET and partial agonist action at 5HT1A sites by norquetiapine may contribute to Seroquel XR's therapeutic efficacy as an antidepressant.
K terapevski antidepresivni učinkovitosti zdravila Seroquel SR morda pripomore norkvetiapin z zavrtjem NET in delnim agonističnim delovanjem na mestih 5HT1A.
• Erythromycin or clarithromycin (for infections).
• eritromicin, klaritromicin (zdravila proti okužbam), • nefazodon (zdravila proti depresiji).
Therefore, Seroquel should be used with caution in patients with known hepatic impairment, especially during the initial dosing period.
Seroquel uporabljati previdno, še posebej v začetnem obdobju zdravljenja.
Weight gain has been seen in patients taking Seroquel.
Povečanje telesne mase Pri bolnikih, ki so prejemali zdravilo Seroquel, so opazili povečanje telesne mase.
Severe neutropenia (neutrophil count <0.5 X 109/L) has been reported in quetiapine clinical trials.
V kliničnih preskušanjih s kvetiapinom so poročali o hudi nevtropeniji (število nevtrofilcev < 0,5 x 109/l).
12 blisters of 10 tablets (150 mg and 300 mg tablets only)
12 pretisnih omotov po 10 tablet (samo 150 mg in 300 mg tablete)
• Increased levels of sugar in the blood.
• zvišan sladkor v krvi, • zamegljen vid,
First trimester
Prvo trimesečje
• A combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome).” Immediate medical treatment may be needed.
• kombinacija zvišane telesne temperature (vročina), znojenja, togosti mišic, občutka hude zaspanosti ali omedlevice (to motnjo imenujemo "nevroleptični maligni sindrom"),
Seroquel 25 mg tablets are peach coloured, round biconvex and engraved with SEROQUEL 25 on one side
Seroquel 25 mg tablete so breskove barve, okrogle, bikonveksne in z vtisnjeno oznako SEROQUEL 25 na eni strani.
What you need to know before you take Seroquel XR
Kaj morate vedeti, preden boste vzeli zdravilo Seroquel SR Ne jemljite zdravila Seroquel SR
Quetiapine should be discontinued in patients with a neutrophil count <1.0 X 109/L.
Pri bolnikih s številom nevtrofilcev < 1,0 x 109/l je treba uporabo kvetiapina prekiniti.
In this study patients randomised to Seroquel XR received 50 mg/day on Days 1-3, the dose could be increased to 100 mg/day on Day 4, 150 mg/day on Day 8 and up to 300 mg/day depending on clinical response and tolerability.
Odmerek je bilo mogoče 4. dan povečati na 100 mg/dan, 8. dan na 150 mg/dan in potem do 300 mg/dan, odvisno od kliničnega odziva in prenašanja.
In a fertility study in rats, marginal reduction in male fertility and pseudopregnancy, protracted periods of diestrus, increased precoital interval and reduced pregnancy rate were seen.
V študiji plodnosti pri podganah so opažali mejno zmanjšanje plodnosti samcev in psevdobrejost,
Quetiapine exhibits minimal dystonic liability in haloperidol-sensitised or drug-naive Cebus monkeys after acute and chronic administration.
Pri opicah vrste Cebus, senzibiliziranih s haloperidolom ali naivnih za zdravila,
In a 6-week, randomised, study of lithium and SEROQUEL XR versus placebo and SEROQUEL XR in adult patients with acute mania, a higher incidence of extrapyramidal related events (in particular tremor), somnolence, and weight gain were observed in the lithium add-on group compared to the placebo add-on group (see section 5.1).
Seroquel SR, pri odraslih bolnikih z akutno manijo, so v skupini z dodatkom litija opažali večjo incidenco ekstrapiramidnih povezanih dogodkov (zlasti tremorja), zaspanosti in povečanja telesne mase kot v skupini z dodatkom placeba (glejte poglavje 5.1).
In addition, a 6-week placebo controlled study for the treatment of schizophrenia (n=222 patients, aged 13-17) was performed.
Poleg tega je bila opravljena 6-tedenska, s placebom kontrolirana študija za zdravljenje shizofrenije
• Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad.
• bipolarne depresije in velike depresivne epizode pri veliki depresivni motnji: ko se lahko počutite žalostne ali depresivne, krive, brez energije, izgubite apetit ali ne morete spati.
Tardive Dyskinesia:
Presnovno tveganje:
In placebo controlled clinical trials of adult patients quetiapine was associated with an increased incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for major depressive episodes in bipolar disorder(see sections 4.8 and 5.1).
V kliničnih, s placebom kontroliranih preskušanjih pri odraslih bolnikih je bil kvetiapin med zdravljenjem hudih obdobij depresije pri bolnikih z bipolarno motnjo povezan z večjo incidenco ekstrapiramidnih simptomov (EPS) kot placebo (glejte poglavji 4.8 in 5.1).
In particular, reports of adverse events related to EPS and weight gain did not increase with longer-term treatment with Seroquel XR.
Še zlasti med dolgotrajnim zdravljenjem z zdravilom Seroquel SR niso zabeležili več z EPU povezanih neželenih dogodkov in povečanja telesne mase.
How to take Seroquel XR
Kako jemati zdravilo Seroquel SR
• Inappropriate secretion of a hormone that controls urine volume.
• neustrezno izločanje antidiuretičnega hormona,
Quetiapine produces only weak catalepsy at effective dopamine D2-receptor blocking doses.
Ob odmerkih, ki učinkovito blokirajo dopaminske receptorje D2, povzroči kvetiapin le šibko katalepsijo.
2 blisters of 10 tablets
2 pretisna omota po 10 tablet
Use in children and adolescents Seroquel should not be used by children and adolescents aged under 18 years.
Uporaba pri otrocih in mladostnikih Zdravilo Seroquel se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
(28) Based on shifts from normal baseline to potentially clinically important value at anytime post-baseline in all trials.
(28) Na podlagi odklonov od normalnih izhodiščnih vrednosti do potencialno klinično pomembnih vrednost kadarkoli v kliničnih raziskavah.
Therefore, Seroquel XR should be used with caution in patients with known hepatic impairment, especially during the initial dosing period.
Seroquel SR uporabljati previdno, še posebej v začetnem obdobju zdravljenja.
Seroquel XR should be administered once daily, without food.
Zdravilo Seroquel SR je treba jemati enkrat na dan, brez hrane (vsaj eno uro pred obrokom).
Seroquel contains lactose
Zdravilo Seroquel vsebuje laktozo
INFORMATION IN BRAILLE Seroquel XR 200 mg
PODATKI V BRAILLOVI PISAVI seroquel sr 200 mg
Seroquel 300 mg film-coated tablets are white, capsule-shaped and engraved with SEROQUEL on one side and 300 on the other side
Seroquel 300 mg filmsko obložene tablete so bele barve, kapsulaste oblike in z vtisnjeno oznako SEROQUEL 300 na eni strani.
• Serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
• huda, nenadna alergijska reakcija s simptomi, kot so zvišana telesna temperatura in mehurji na koži ter luščenje kože (toksična epidermalna nekroliza), • odtegnitveni simptomi se lahko pojavijo novorojenčkom mater, ki so med nosečnostjo jemale zdravilo Seroquel.
The recommended daily dose is 600 mg, however if clinically justified the dose may be increased to 800 mg daily.
Dnevni odmerek na začetku zdravljenja je 300 mg 1. dan in 600 mg 2. dan. Priporočeni dnevni odmerek je 600 mg, vendar se lahko, če je klinično upravičeno, odmerek poveča do 800 mg. Odmerek je treba prilagoditi v učinkovitem razponu odmerkov od 400 mg do 800 mg na dan, odvisno od kliničnega odziva in bolnikovega prenašanja.
Use in children and adolescents Seroquel XR should not be used by children and adolescents aged under 18 years.
Uporaba pri otrocih in mladostnikih Zdravilo Seroquel SR se ne sme uporabljati pri otrocih in mladostnikih mlajših od 18 let.
Quetiapine is extensively metabolised by the liver.
Biotransformacija: Kvetiapin se izdatno presnovi v jetrih.
INFORMATION IN BRAILLE Seroquel XR 150 mg
PODATKI V BRAILLOVI PISAVI seroquel sr 150 mg
In short-term, placebo-controlled monotherapy clinical trials in major depressive disorder the aggregated incidence of extrapyramidal symptoms was 5.4% for Seroquel XR and 3.2% for placebo.
V kratkotrajnih, s placebom kontroliranih kliničnih preskušanjih monoterapije pri hudi depresivni motnji je bila skupna incidenca ekstrapiramidnih simptomov med uporabo zdravila Seroquel SR 5,4 %
(27) Based on shifts from normal baseline to potentially clinically important value at anytime post-baseline in all trials.
(27) Na podlagi odklonov od normalnih izhodiščnih vrednosti do potencialno klinično pomembnih vrednosti kadarkoli v kliničnih raziskavah.
5 blisters of 10 tablets
5 pretisnih omotov po 10 tablet
(13) Platelets ≤100 x 10
Premiki so opredeljeni kot ≤ 3 x 10
Weight gain has been seen in patients taking Seroquel XR.
Povečanje telesne mase Pri bolnikih, ki so prejemali zdravilo Seroquel SR, so opazili povečanje telesne mase.
In a short-term (9 week) study non-demented elderly patients (aged 66 to 89 years) with major depressive disorder, Seroquel XR dosed flexibly in the range of 50 mg to 300 mg/day demonstrated superior efficacy to placebo in reducing depressive symptoms as measured by improvement in MADRS total score (LS mean change vs placebo -7.54).
V kratkotrajni (9-tedenski) študiji nedementnih starejših bolnikov (starih od 66 do 89 let) z MDD, je bila učinkovitost zdravila Seroquel SR (prilagodljivo odmerjanega v razponu od 50 mg do
10 blisters of 5 tablets
10 pretisnih omotov po 5 tablet
The daily dose at the start of therapy is 50 mg on Day 1 and 2, and 150 mg on Day 3 and 4.
50 mg 1. in 2. dan ter 150 mg 3. in 4. dan.
Ferric Oxide, Yellow (E172) 25 mg, 100 mg and 150 mg tablets) Ferric Oxide, Red (E172) (25 mg tablets)
Filmska obloga tablete: hipromeloza (E 464), makrogol 400, titanov dioksid (E 171), rumeni železov oksid (E 172) (25-mg, 100-mg in 150-mg tablete), rdeči železov oksid (E 172) (25-mg tablete).
Each tablet contains 200 mg quetiapine (as fumarate)
Ena tableta vsebuje 200 mg kvetiapina (v obliki fumarata).
• Vomiting
• bruhanje,
In two recurrence prevention studies evaluating Seroquel in combination with mood stabilizers, in patients with manic, depressed or mixed mood episodes, the combination with Seroquel was superior to mood stabilizers monotherapy in increasing the time to recurrence of any mood event (manic, mixed or depressed).
V dveh študijah preprečevanja recidivov so ocenjevali zdravilo Seroquel v kombinaciji s stabilizatorji razpoloženja pri bolnikih z maničnimi, depresivnimi ali mešanimi epizodami razpoloženja.
300mg of quetiapine (as quetiapine fumarate).
200 mg ali 300 mg kvetiapina (v obliki kvetiapinijevega fumarata).
Antidepressant effect was seen at 150 and 300 mg/day in shortterm trials as add-on therapy (with amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline and venlafaxine - see Section 5.1) and at 50 mg/day in short-term monotherapy trials.
paroksetinom, sertralinom in venlafaksinom - glejte poglavje 5.1) je bil antidepresivni učinek opazen pri 150 in 300 mg/dan in pri 50 mg/dan v kratkotrajnih preskušanjih monoterapije.
Quetiapine should be used with caution in patients with risk factors for stroke.
Pri bolnikih z dejavniki tveganja za možgansko kap je treba kvetiapin uporabljati previdno.
Elimination
Odtegnitev
The pharmacokinetics of quetiapine were not significantly altered by co-administration of the antipsychotics risperidone or haloperidol.
Pri sočasnem jemanju kvetiapina z antipsihotikom risperidonom ali haloperidolom se farmakokinetika kvetiapina ne spremeni v znatni meri.
Very common side effects (may affect more than 1 in 10 people):
Zelo pogosti neželeni učinki: pojavijo se lahko pri več kot 1 od 10 bolnikov
Seroquel 200 mg film-coated tablets are white, round biconvex and engraved with SEROQUEL 200 on one side
Seroquel 200 mg filmsko obložene tablete so bele barve, okrogle, bikonveksne in z vtisnjeno oznako SEROQUEL 200 na eni strani.
Angioedema5, StevensJohnson syndrome
Bolezni kože in podkožja angioedem5, StevensJohnsonov sindrom toksična epidermal na nekroliza, multiform ni eritem
In two recurrence prevention studies evaluating quetiapine in combination with mood stabilizers, in patients with manic, depressed or mixed mood episodes, the combination with quetiapine was superior to mood stabilizers monotherapy in increasing the time to recurrence of any mood event (manic, mixed or depressed).
V dveh študijah preprečevanja recidivov so ocenjevali kvetiapin v kombinaciji s stabilizatorji razpoloženja pri bolnikih z maničnimi, depresivnimi ali mešanimi epizodami razpoloženja.
INFORMATION IN BRAILLE Seroquel XR 400 mg
PODATKI V BRAILLOVI PISAVI seroquel sr 400 mg
NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg, 100 mg and 200 mg tablets quetiapine
IME ZDRAVILA Seroquel 25 mg, 100 mg in 200 mg tablete kvetiapin
• Keep this medicine out of the reach and sight of children.
• Zdravilo shranjujte nedosegljivo otrokom!
• A long-lasting and painful erection (Priapism).
• napadi krčev (konvulzije), • dolgotrajna ali boleča erekcija (priapizem).
Cardiac disorders
Zapoznela diskinezija
Seroquel 150 mg film-coated tablets are pale yellow, round biconvex and engraved with SEROQUEL 150 on one side
Seroquel 150 mg filmsko obložene tablete so bledorumene, okrogle, bikonveksne in z vtisnjeno oznako SEROQUEL 150 na eni strani.
The efficacy of Seroquel XR was further demonstrated with significance versus placebo in an additional 3 week study.
Seroquel SR, v primerjavi s placebom, se je ohranil vse do konca 3-tedenskega preskušanja.
How to store Seroquel
Shranjevanje zdravila Seroquel
Elevations in serum aspartate aminotransferas e (AST)
zvišanje aspartataminotransfer aze (AST) v serumu zlatenica hepatitis
Each tablet contains 300 mg quetiapine (as fumarate)
Ena tableta vsebuje 300 mg kvetiapina (v obliki fumarata).
• Diabetes
• sladkorna bolezen,
Day 3
(4. dan).
Each tablet contains 400 mg quetiapine (as fumarate)
Ena tableta vsebuje 400 mg kvetiapina (v obliki fumarata).
Neutropenia
Konvulzije
Seroquel 100 mg film-coated tablets are yellow, round biconvex and engraved with SEROQUEL 100 on one side
Seroquel 100 mg filmsko obložene tablete so rumene barve, okrogle, bikonveksne in z vtisnjeno oznako SEROQUEL 100 na eni strani.
Seroquel should not be taken if you are breast-feeding.
Zdravila Seroquel ne jemljite v času dojenja.
QUALITATIVE AND QUANTITATIVE COMPOSITION Seroquel 25 mg contains 25 mg quetiapine (as quetiapine fumarate) Excipient : 18 mg lactose (anhydrous) per tablet
Zdravilo Seroquel 25 mg vsebuje 25 mg kvetiapina (v obliki kvetiapinijevega fumarata).
NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg, 100 mg and 200 mg film-coated tablets quetiapine
IME ZDRAVILA Seroquel 25 mg, 100 mg in 200 mg filmsko obložene tablete kvetiapin
Each tablet contains 150 mg quetiapine (as fumarate)
Ena tableta vsebuje 150 mg kvetiapina (v obliki fumarata).
Seroquel XR should not be taken if you are breast-feeding.
Zdravila Seroquel SR ne jemljite v času dojenja.
9 blisters of 10 tablets
9 pretisnih omotov po 10 tablet
6.5 Nature and contents of container Polychlorotrifluoroethylene and polyvinylchloride with aluminium blister
6.5 Vrsta ovojnine in vsebina Pretisni omoti iz PVC+PCTFE/aluminija.
6 blisters of 10 tablets
6 pretisnih omotov po 10 tablet
INFORMATION IN BRAILLE Seroquel XR 300 mg
PODATKI V BRAILLOVI PISAVI seroquel sr 300 mg
For the treatment of major depressive episodes in bipolar disorder Seroquel XR should be administered at bedtime.
Za zdravljenje velikih depresivnih epizod pri bipolarni motnji Zdravilo Seroquel SR se jemlje 1x dnevno, pred spanjem.
In placebo-controlled clinical trials with children and adolescent patients, quetiapine was associated with an increased incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for schizophrenia, bipolar mania, and bipolar depression (see section 4.8).
V kliničnih, s placebom kontroliranih preskušanjih zdravljenja shizofrenije, bipolarne manije in bipolarne depresije pri otrocih in mladostnikih, je kvetiapin spremljala večja incidenca ekstrapiramidnih simptomov (EPS) kot placebo (glejte poglavje 4.8).
NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg and 100 mg tablets quetiapine
IME ZDRAVILA Seroquel 25 mg in 100 mg tablete kvetiapin
• If you get any side effects talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
This leaflet was last approved in {MM/YYYY}.
Seroquel Navodilo je bilo nazadnje revidirano dne {MM/LLLL}.