natgillin/translations-raw huggingface dataset:
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.
ekstrapiramidne motnje, tremorja, diskinezije, distonije, nemira, nehotnih mišičnih kontrakcij, psihomotorične hiperaktivnosti in mišične togosti) v nobeni terapevtski skupini presegla 4 %.
How to take Seroquel
Kako jemati zdravilo Seroquel
Very Common Common
Zelo pogosti Pogosti
Patients with hepatic impairment should be started on 50 mg/day.
Pri bolnikih z okvaro jeter je treba zdravljenje začeti s 50 mg/dan.
6 x 25 mg film-coated tablets 3 x 100 mg film-coated tablets 1 x 200 mg film-coated tablets
6 x 25 mg filmsko obloženih tablet 3 x 100 mg filmsko obloženih tablet 1 x 200 mg filmsko obloženih tablet
• A slower than normal heart rate which may occur when starting treatment and which may be associated with low blood pressure and fainting.
• nenormalno počasno bitje srca; pojavi se lahko na začetku zdravljenja in ga lahko spremljata nizek krvni tlak in omedlevica, • težave pri odvajanju urina,
This includes fatal reports in patients who are at higher risk of intestinal obstruction, including those that are receiving multiple concomitant medications that decrease intestinal motility and/or may not report symptoms of constipation.
To vključuje smrtne primere pri bolnikih z večjim tveganjem za zaporo črevesa, vključno s tistimi, ki sočasno prejemajo več zdravil, ki zmanjšujejo motiliteto črevesa; ti bolniki lahko navajajo simptome zaprtosti ali pa ne. Bolnike z zaporo črevesa/ileusom je treba obravnavati s skrbnim nadzorom in nujnim zdravljenjem.
<[To be completed nationally]>
<izpolni država članica>
If you take more Seroquel XR than prescribed by your doctor, you may feel sleepy, feel dizzy and experience abnormal heart beats.
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.
In 4 clinical trials with a duration of 8 weeks in patients with moderate to severe depressive episodes in bipolar I or bipolar II disorder, Seroquel IR 300 mg and 600 mg was significantly superior to placebo treated patients for the relevant outcome measures: mean improvement on the MADRS and for response defined as at least a 50% improvement in MADRS total score from baseline.
V štirih 8-tedenskih kliničnih preskušanjih pri bolnikih z zmernimi do hudimi depresivnimi epizodami v okviru bipolarne motnje I ali II, je bilo zdravilo Seroquel v odmerkih 300 mg in 600 mg statistično značilno boljše od placeba pri relevantnih merilih izida: povprečnem izboljšanju MADRS in odzivu, opredeljenem kot izboljšanje celotnega seštevka MADRS za vsaj 50 % v primerjavi z izhodiščem.
Seroquel XR contains lactose which is a type of sugar.
Zdravilo Seroquel SR vsebuje laktozo, ki je vrsta sladkorja.
Patients with known hepatic impairment should be started with 25 mg/day.
Pri bolnikih z okvaro jeter je treba zdravljenje začeti s 25 mg/dan.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 27 April 1998
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
6 tablets
6 tablet
This could increase the risk of accidental injury (fall)
To lahko poveča tveganje naključnih poškodb (padcev) pri starejših bolnikih,
INFORMATION IN BRAILLE Seroquel 100 mg (or 150 mg, or 200 mg or 300 mg)
PODATKI V BRAILLOVI PISAVI seroquel 100 mg (ali 150 mg ali 200 mg ali 300 mg)
Quetiapine is well absorbed and extensively metabolised following oral administration.
Kvetiapin se po peroralnem vnosu dobro absorbira in obsežno presnavlja.
• Feeling irritated
• občutek razdražljivosti,
For 100 mg, 150 mg, 200 mg and 300 mg tablets pack sizes of 10, 90 are registered.
Za jakosti 100 mg, 150 mg, 200 mg in 300 mg so registrirana tudi pakiranja po 10 in 90 tablet.
The pharmacokinetics of sodium valproate and quetiapine were not altered to a clinically relevant extent when co-administered.
Sočasno jemanje natrijevega valproata in kvetiapina ne spremeni njune farmakokinetike v klinično pomembnem obsegu.
1 blister of 6 tablets
1 pretisni omot po 6 tablet
Summary of product characteristics, labelling and package leaflet
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA
1 blister containing 6 x 25 mg and 2 x 100 mg tablets
1 pretisni omot, ki vsebuje 6 x 25 mg in 2 x 100 mg tableti
Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression.
Podatki iz kliničnih preskušanj kažejo, da pri mlajših odraslih (starih manj kot 25 let) z depresijo obstaja večje tveganje za pojav samomorilnih misli in/ali samomorilnega vedenja.
Seroquel XR was dosed in the range of 400 to 800 mg/day and the mean dose was approximately 600 mg/day.
Seroquel SR so uporabljali v odmerkih od 400 do 800 mg/dan in povprečni odmerek je bil približno
Tell your doctor if you are taking any of the following medicines:
Povejte svojemu zdravniku, če jemljete:
Quetiapine 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.
Kvetiapina ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker ni podatkov, ki bi podpirali njegovo uporabo v tej starostni skupini.
In three placebo-controlled clinical trials, in patients with schizophrenia, using variable doses of quetiapine, there were no differences between the Seroquel and placebo treatment groups in the incidence of EPS or concomitant use of anticholinergics.
Rezultati treh s placebom nadzorovanih kliničnih preskušanj pri bolnikih s shizofrenijo pri različnih odmerkih kvetiapina ne kažejo na razlike glede pogostnosti EPU ali sočasne uporabe antiholinergikov med skupino, ki je prejemala zdravilo Seroquel, in skupino, ki je prejemala placebo.
Seroquel contains a substance called quetiapine.
Zdravilo Seroquel vsebuje učinkovino imenovano kvetiapin.
In four placebo-controlled clinical trials, evaluating doses of Seroquel up to 800 mg/day for the treatment of moderate to severe manic episodes, two each in monotherapy and as combination therapy to lithium or divalproex, there were no differences between the Seroquel and placebo treatment groups in the incidence of EPS or concomitant use of anticholinergics.
V štirih s placebom nadzorovanih preskušanjih, od katerih so v dveh uporabili kvetiapin kot samostojno zdravljenje in v kombiniranem zdravljenju z litijem ali valproatom, so ocenjevali odmerke zdravila Seroquel do 800 mg/dan pri zdravljenju zmernih do hudih maničnih epizod; opazili niso nobenih razlik v pogostnosti EPU ali sočasne uporabe antiholinergikov med skupino, ki je prejemala zdravilo Seroquel, in skupino, ki je prejemala placebo.
1 blister containing 6 x 25mg, 3 x 100mg and 1 x 200mg tablets
1 pretisni omot, ki vsebuje 6 x 25 mg, 3 x 100 mg in 1 x 200 mg tableto
The rates of weight gain ≥ 7% of baseline body weight in the active arm vs. placebo were 17% vs. 2.5% in the schizophrenia and bipolar mania trials, and 12.5% vs. 6% in the bipolar depression trial.
Delež povečanja telesne mase za ≥ 7 % od izhodiščne je bil v preskušanjih pri shizofreniji in bipolarni maniji v kraku z učinkovino 17 % in v kraku s placebom 2,5 %, v preskušanju pri bipolarni depresiji pa 12,5 % (učinkovina) in 6 %
The need to increase the dose from 150 to 300 mg/day should be based on individual patient evaluation.
na 300 mg/dan mora temeljiti na oceni posameznega bolnika.
Talk to your doctor or pharmacist before taking Seroquel if:
Pred začetkom jemanja zdravila Seroquel se posvetujte z zdravnikom ali farmacevtom če:
Patients with a history of suicide related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Znano je, da je tveganje za pojav samomorilnih misli oz. za poskus samomora večje pri bolnikih z anamnezo dogodkov, povezanih s samomorom, in bolnikih, pri katerih je pred začetkom zdravljenja v veliki meri prisotno samomorilno razmišljanje.
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) and very rare (<1/10,000).
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).
(YMRS improvement ≥50%) were 64% for Seroquel 400 mg/day, 58% for 600 mg/day and 37% in the placebo arm.
so bili 64 % za zdravilo Seroquel 400 mg/dan, 58 % za 600 mg/dan in 37 % v kraku s placebom.
100 blisters of 1 tablet
100 pretisnih omotov po 1 tableto
In all clinical trials (placebo-controlled, open-label, active comparator) in patients with a baseline neutrophil count ≥1.5 X 109/L, the incidence of at least one occurrence of a shift to neutrophil count <1.5 x 109/L was 2.9% and to <0.5 X 109/L was 0.21% in patients treated with quetiapine.
V vseh kliničnih preskušanjih (s placebom kontroliranih, odprtih in s primerjalno učinkovino) pri bolnikih z izhodiščnim številom nevtrofilcev ≥ 1,5 x 109/l je bila incidenca vsaj ene spremembe števila nevtrofilcev na < 1,5 x 109/l med prejemniki kvetiapina, ki so imeli izhodiščno število nevtrofilcev ≥ 1,5 x 109/l 2,9 % in na < 0,5 x 109/l 0,21 % pri bolnikih, ki so prejemali kvetiapin.
Do not store above 30°C.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C.
In three out of four short term (up to 8 weeks) monotherapy studies, in patients with major depressive disorder, Seroquel XR 50 mg, 150 mg and 300 mg/day demonstrated superior efficacy to placebo in reducing depressive symptoms as measured by improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score (LS mean change vs. placebo of 2-4 points).
V treh od štirih kratkotrajnih (do 8 tednov) študij monoterapije je Seroquel SR 50 mg, 150 mg in 300 mg/dan pri bolnikih z MDD v primerjavi s placebom pokazal superiorno učinkovitost za zmanjšanje depresivnih simptomov, merjeno s celotno oceno po lestvici MADRS (Montgomery
The efficacy of Seroquel XR in the treatment of schizophrenia was demonstrated in one 6-week placebocontrolled trial in patients who met DSM-IV criteria for schizophrenia, and one active-controlled Seroquel immediate release-to-Seroquel XR switching study in clinically stable outpatients with schizophrenia.
Učinkovitost zdravila Seroquel SR za zdravljenje shizofrenije so dokazali v enem 6-tedenskem s placebom kontroliranem preskušanju pri bolnikih, ki so izpolnjevali merila za shizofrenijo po DSM
The incidence of somnolence was higher in the SEROQUEL XR with lithium add-on group (12.7%) compared to the SEROQUEL XR with the placebo add-on group (5.5%).
Incidenca zaspanosti je bila večja v skupini, ki je prejemala zdravilo Seroquel SR z dodatkom litija (12,7 %) kot v skupini, ki je prejemala zdravilo Seroquel SR z dodatkom placeba
• Stuffy nose.
• zamašen nos,
In short term, fixed dose (50mg/d to 800 mg/d), placebo-controlled studies (ranging from 3 to 8 weeks), the mean weight gain for quetiapine-treated patients ranged from 0.8 kg for the 50 mg daily dose to 1.4 kg for the 600 mg daily dose (with lower gain for the 800 mg daily dose), compared to 0.2 kg for the placebo treated patients.
V kratkotrajnih, s placebom kontroliranih študijah s stalnim odmerkom (od 50 do 800 mg/dan), ki so trajale od 3 do 8 tednov, se je bolnikom, ki so prejemali kvetiapin, telesna masa v povprečju povečala od 0,8 kg z dnevnim odmerkom 50 mg do 1,4 kg z dnevnim odmerkom 600 mg (z manjšim povečanjem z dnevnim odmerkom 800 mg); pri bolnikih, ki so prejemali placebo, je bilo to povečanje
Quetiapine is extensively metabolised by the liver, with parent compound accounting for less than 5% of unchanged drug-related material in the urine or faeces, following the administration of radiolabelled quetiapine.
Po uporabi radioaktivno označenega kvetiapina predstavlja matična spojina manj kot 5 % nespremenjene snovi v urinu ali blatu.
In the short-term pediatric trials with quetiapine described above, the rates of EPS in the active arm vs. placebo were 12.9% vs. 5.3% in the schizophrenia trial, 3.6% vs. 1.1% in the bipolar mania trial, and 1.1%
V kratkotrajnih pediatričnih preskušanjih s kvetiapinom, opisanih zgoraj, so bili deleži ekstrapiramidnih simptomov v preskušanju pri shizofreniji v kraku z učinkovino 12,9 % in v kraku s placebom 5,3 %, v preskušanju pri bipolarni maniji 3,6 % (učinkovina) in 1,1 % (placebo) ter v preskušanju pri bipolarni depresiji 1,1 % (učinkovina) in 0 % (placebo).
In the treatment of moderate to severe manic episodes, Seroquel demonstrated superior efficacy to placebo in reduction of manic symptoms at 3 and 12 weeks, in two monotherapy trials.
Bipolarna motnja Pri zdravljenju zmernih do hudih epizod manije je zdravilo Seroquel v dveh preskušanjih monoterapije po 3 in 12 tednih manične simptome zmanjšalo učinkoviteje kot placebo.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
Nadaljnje prilagajanje odmerka do 800 mg na dan do 6.
There were no additional safety findings associated with treatment with Seroquel XR for up to 9 months (median 7 months).
Seroquel SR v obdobju do 9 mesecev (mediano 7 mesecev) ni bilo dodatnih izsledkov povezanih z varno uporabo zdravila.
Calcium Hydrogen Phosphate Dihydrate Microcrystalline Cellulose Sodium Starch Glycolate Type A Lactose Monohydrate Magnesium Stearate
Jedro povidon kalcijev hidrogenfosfat dihidrat mikrokristalna celuloza natrijev karboksimetilškrob (vrste A) laktoza monohidrat magnezijev stearat
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva rabdomioliza
100 mg, 150 mg, 200 mg and 300 mg tablets
100 mg, 150 mg, 200 mg in 300 mg tablete
Patients should be advised to immediately report the appearance of signs/symptoms consistent with agranulocytosis or infection (e.g., fever, weakness, lethargy, or sore throat) at any time during Seroquel therapy.
Bolnikom je treba naročiti, da morajo nemudoma obvestiti zdravnika, če se jim kadar koli med zdravljenjem z zdravilom Seroquel pojavijo znaki ali simptomi, ki bi lahko bili posledica agranulocitoze ali okužbe (npr. zvišana telesna temperatura, šibkost, letargija ali vnetje žrela).
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs.
Pri uporabi antipsihotičnih zdravil so poročali o primerih venske tromboembolije.
The dosage should be increased daily with increments of 25-50 mg/day until an effective dosage, depending on the clinical response and tolerability of the individual patient.
Odmerek je mogoče povečevati za 25 do 50 mg/dan do učinkovitega odmerka, odvisno od bolnikovega individualnega kliničnega odziva in prenašanja.
The incidence of shifts to >0.5-<1.0 x 109/L was the same (0.2%) in patients treated with quetiapine as with placebo-treated patients.
Incidenca sprememb na > 0,5 do < 1,0 x 109/l je bila med prejemniki kvetiapina in placeba enaka
A 26-week open-label extension to the acute trials (n=380 patients), with Seroquel flexibly dosed at 400800 mg/day, provided additional safety data.
Dodatni podatki o varnosti izvirajo iz 26-tedenskega odprtega nadaljevanja akutnih preskušanj (n = 380 bolnikov), med katerim so zdravilo Seroquel uporabljali v prilagodljivih odmerkih od 400 do 800 mg na dan.
3-Day Starterpack (Combined pack)
ŠKATLA (3-dnevno začetno pakiranje)
The rates of suicide related events in the active arm vs. placebo were 1.4% vs. 1.3% in the schizophrenia trial, 1.0% vs. 0% in the bipolar mania trial, and 1.1% vs. 0% in the bipolar depression trial.
Delež s samomorom povezanih dogodkov je bil v preskušanju pri shizofreniji v kraku z učinkovino 1,4 % in v kraku s placebom 1,3 %, v preskušanju pri bipolarni maniji 1,0 % (učinkovina) in 0 % (placebo) in v preskušanju pri bipolarni depresiji 1,1 % (učinkovina) in 0 % (placebo).
• Swelling of breasts and unexpected production of breast milk (galactorrhoea).
• dolgotrajna in boleča erekcija (priapizem), • otečene prsi in nepričakovano izločanje mleka (galaktoreja),
If you do, your doctor may check your blood sugar levels while you are taking Seroquel.
vam bo zdravnik med jemanjem zdravila Seroquel preverjal koncentracijo sladkorja v krvi.
• Discontinuation symptoms (symptoms which occur when you stop taking Seroquel) include not being able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea, being sick (vomiting),
• odtegnitveni simptomi (simptomi, ki se pojavijo po prenehanju jemanja zdravila Seroquel ), ki vključujejo težave s spanjem (nespečnost), siljenje na bruhanje, glavobol, drisko, bruhanje, omotico in razdražljivost.
The following table summarises ADRs that occur in a higher frequency category in children and adolescents patients (10-17 years of age) than in the adult population or ADRs that have not been identified in the adult population.
(starih od 10 do 17 let) pojavljajo v višji kategoriji pogostnosti kot v odrasli populaciji, ali neželene učinke zdravila, ki niso bili ugotovljeni v odrasli populaciji.
Thoughts of suicide and worsening of your depression If you are depressed you may sometimes have thoughts of harming or killing yourself.
Če ste depresivni, se vam občasno lahko pojavijo misli na samopoškodovanje ali samomor.
Seroquel XR 50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets quetiapine
Seroquel SR 50 mg, 150 mg, 200 mg, 300 mg, 400 mg tablete s podaljšanim sproščanjem kvetiapin
Seroquel XR should be administered prior to bedtime.
Zdravilo Seroquel SR je treba vzeti pred spanjem.
50 mg, 150 mg 200 mg, 300 mg and 400 mg tablets
50 mg, 150 mg, 200 mg, 300 mg in 400 mg tablete
There is an increased risk of adverse events at higher doses.
Z večjimi odmerki obstaja večje tveganje neželenih učinkov.
The pharmacokinetics of quetiapine were not significantly altered by co-administration of the antidepressants imipramine (a known CYP 2D6 inhibitor) or fluoxetine (a known CYP 3A4 and CYP 2D6 inhibitor).
CYP 2D6) ali fluoksetinom (znanim zaviralcem CYP 3A4 in CYP 2D6) se farmakokinetika kvetiapina ne spremeni v znatni meri.
(26) Based on shift in neutrophils from >=1.5 x 10^9/L at baseline to <0.5 x 10^9/L at any time during treatment and based on patients with severe neutropenia (<0.5 x 109/L) and infection during all quetiapine clinical trials (See Section 4.4).
9/l kadar koli med zdravljenjem in na podlagi bolnikov s hudo nevtropenijo (<0,5 x 10 9/L) in okužbo tekom vseh kliničnih raziskav s kvetiapinom (glejte poglavje 4.4).
If you stop taking Seroquel XR
Če ste prenehali jemati zdravilo Seroquel SR
Major depressive episodes in MDD
Velike depresivne epizode pri veliki depresivni motnji
6.5 Nature and contents of container PVC/aluminium blisters Pack sizes
6.5 Vrsta ovojnine in vsebina PVC/aluminijasti pretisni omoti Pretisni omoti:
• Azole medicines (for fungal infections).
• nekatera zdravila proti glivičnim okužbam (iz skupine azolov),
Metabolic Risk
Presnovno tveganje
Elevations in serum alanine aminotransferas e (ALT)3, Elevatio ns in gammaGT levels3
žolčnika in žolčevodov zvišanje alaninaminotransfer aze (ALT) v serumu zvišanje gama-GT
INFORMATION IN BRAILLE Seroquel 25 mg, 100 mg and 200 mg
PODATKI V BRAILLOVI PISAVI seroquel 25 mg, 100 mg in 200 mg
The frequencies of adverse events are ranked according to the following: Very common (≥1/10), common
Pogostnosti neželenih učinkov je opredeljena kot sledi: zelo pogosti (> 1/10), pogosti (> 1/100 do <
• Increased blood creatine phosphokinase (a substance from the muscles
• zvišanje kreatin-fosfokinaze (snov v mišicah) v krvi.
An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled trials in the dementia population with some atypical antipsychotics.
V randomiziranih, s placebom kontroliranih preskušanjih so v populaciji dementnih bolnikov ob uporabi nekaterih atipičnih antipsihotičnih zdravil zabeležili približno 3-kratno povečanje tveganja za možgansko-žilne neželene učinke.
If you forget to take a dose of Seroquel XR
Če ste pozabili vzeti zdravilo Seroquel SR
Neuroleptic malignant syndrome hypothermia
Nevroleptični maligni sindrom
Seroquel 3-Day Starterpack (Combined pack) contains 6 tablets Seroquel 25 mg and 2 tablets Seroquel 100 mg
Seroquel 4-dnevno začetno pakiranje vsebuje 6 tablet zdravila Seroquel 25 mg, 3 tablete zdravila
In a short-term placebo-controlled monotherapy trial in elderly patients with major depressive disorder, the aggregated incidence of extrapyramidal symptoms was 9.0% for Seroquel XR and 2.3% for placebo.
V kratkotrajnem, s placebom kontroliranem kliničnem preskušanju monoterapije pri starejših bolnikih s hudo depresivno motnjo je bila skupna incidenca ekstrapiramidnih simptomov med uporabo zdravila Seroquel SR 9,0 % in med uporabo placeba 2,3 %.
It can affect the way the medicine works.
Grenivkin sok lahko vpliva na delovanje zdravila.
In short-term, placebocontrolled bipolar depression trials the aggregated incidence of extrapyramidal symptoms was 8.9% for quetiapine compared to 3.8% for placebo.
V kratkotrajnih, s placebom kontroliranih preskušanjih pri bipolarni depresiji je bila skupna incidenca ekstrapiramidnih simptomov med uporabo kvetiapina 8,9 % in med uporabo placeba 3,8 %.
Seroquel 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 ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker ni podatkov, ki bi podpirali njegovo uporabo v tej starostni skupini.
A 6-week, randomised, study of lithium and SEROQUEL XR versus placebo and SEROQUEL XR in adult patients with acute mania indicated that the combination of SEROQUEL XR with lithium leads to more adverse events (63% versus 48% in SEROQUEL XR in combination with placebo).
Seroquel SR pri odraslih bolnikih z akutno manijo je pokazala več neželenih učinkov s kombinacijo zdravila Seroquel SR in litija (63 % v primerjavi z 48 % z zdravilom Seroquel SR v kombinaciji s placebom).
INFORMATION IN BRAILLE Seroquel 25 mg and 100 mg
PODATKI V BRAILLOVI PISAVI seroquel 25 mg in 100 mg
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.
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.
• Decrease in the amount of sodium in the blood
• znižanje koncentracije natrija v krvi.
Renal Impairment
Okvara ledvic
Increases in the hormone prolactin could in rare cases lead to the following: o Boys and girls to have swelling of breasts and unexpectedly produce breast milk o Girls to have no monthly period or irregular periods
Zvišanje hormona prolaktina lahko v redkih primerih povzroči: o moškim in ženskam lahko otečejo prsi in začnejo nepričakovano izločati mleko,
The pharmacokinetics of quetiapine and norquetiapine are linear and dose-proportional for doses up to 800 mg administered once daily.
V odmerkih do 800 mg enkrat na dan je farmakokinetika kvetiapina in norkvetiapina linearna in sorazmerna odmerku.
Pancreatitis Intestinal obstruction/Ileus
pankreatitis1, zapora črevesa/ileus
• Decreases in the number of certain types of blood cells
• spremembe koncentracije ščitničnih hormonov v krvi, • zmanjšanje števila določenih vrst krvnih celic,
The bioavailability of quetiapine is not significantly affected by administration with food.
Jemanje zdravila s hrano na biološko uporabnost kvetiapina nima pomembnega vpliva.
The same ADRs described above for adults should be considered for children and adolescents.
Pri otrocih in mladostnikih je treba upoštevati iste neželene učinke zdravila, kot so zgoraj opisani za odrasle.
INFORMATION IN BRAILLE Seroquel 25 mg
PODATKI V BRAILLOVI PISAVI seroquel 25 mg