natgillin/translations-raw huggingface dataset:
Severe neutropenia (neutrophil count <0.5 X 109/L) has been reported in quetiapine clinical trials.
U kliničkim ispitivanjima kvetiapina prijavljena je teška neutropenija (broj neutrofila <0,5 x 109/L).
• 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.
• kombinaciju visoke tjelesne temperature (vrućice), teške ukočenosti mišića, znojenja ili smanjene razine svijesti (poremećaj koji se zove "neuroleptički maligni sindrom").
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.
Ne preporuča se primjena Seroquela XR u djece i adolescenata mlađih od 18 godina zbog nedostatka podataka koji bi poduprli primjenu u toj dobnoj skupini.
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.
Sve tablete s produljenim oslobađanjem su oblika kapsule s utisnutim oznakom “XR” i oznakom jačine.Tablete od 50 mg su boje breskve, tablete od 150 mg su bijele boje, tablete od 200 mg su žute boje, tablete od 300 mg su svijetložute boje, a tablete od 400 mg su bijele boje.
Triglycerides ≥200 mg/dL (≥2.258 mmol/L) (patients ≥18 years of age) or ≥150 mg/dL (≥1.694 mmol/L)
Barem jednom izmjerena vrijednost triglicerida ≥ 200 mg/dL (≥ 2,258 mmol/L) (bolesnici ≥ 18 godina starosti) ili ≥150 mg/dL (≥1,694 mmol/L) (bolesnici < 18 godina starosti).
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).
U placebom kontroliranim kliničkim ispitivanjima, u kojima su sudjelovala djeca i adolescenti, kvetiapin je bio povezan s povećanom incidencijom ekstrapiramidnih simptoma u usporedbi s placebom u bolesnika liječenih zbog shizofrenije, bipolarne manije i bipolarne depresije (vidjeti dio 4.8).
Inhibition of NET and partial agonist action at 5HT1A sites by norquetiapine may contribute to Seroquel XR's therapeutic efficacy as an antidepressant.
5HT1A receptora pridonosi terapijskoj djelotvornosti Seroquela XR kao antidepresiva.
1 blister of 6 tablets
1 blister sa 6 tableta
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 and major depressive disorder (see sections 4.8 and 5.1).
U placebom kontroliranim kliničkim ispitivanjima odraslih bolesnika kvetiapin je povezan s povećanom incidencijom ekstrapiramidnih simptoma (EPS) u usporedbi s placebom u bolesnika liječenih od velikih depresivnih epizoda u bipolarnom poremećaju i u velikom depresivnom poremećaju (vidjeti dio 4.8 i 5.1).
24 blisters of 10 tablets (150 mg and 300 mg tablets only)
24 blistera s 10 tablets (samo za tablete od 150 mg i 300 mg)
For the treatment of major depressive episodes in bipolar disorder Seroquel should be administered once daily at bedtime.
Za liječenje velikih depresivnih epizoda u bipolarnom poremećaju Seroquel je potrebno uzimati jednom dnevno prije spavanja.
Very rare side effects (may affect up to 1 in 10,000 people):
Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba):
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).
U placebom kontroliranim kliničkim ispitivanjima odraslih bolesnika, kvetiapin je povezan s povećanom incidencijom ekstrapiramidnih simptoma (EPS) u usporedbi s placebom u bolesnika liječenih od velikih depresivnih epizoda u bipolarnom poremećaju (vidjeti dijelove 4.8 i 5.1).
• Do not drink grapefruit juice while you are taking Seroquel XR.
• Tijekom liječenja Seroquelom XR nemojte piti sok od grejpa.
INFORMATION IN BRAILLE Seroquel 25 mg, 100 mg and 200 mg
16. PODACI NA BRAILLEOVOM PISMU Seroquel 25 mg, 100 mg i 200 mg
If you do, your doctor may check your blood sugar levels while you are taking Seroquel.
U tom slučaju, tijekom liječenja Seroquelom liječnik Vam može provjeravati razinu šećera u krvi.
In all short-term placebo-controlled monotherapy trials 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 1.9% in patients treated with quetiapine compared to 1.5% in placebo-treated patients.
U svim kratkoročnim, placebo-kontroliranim kliničkim ispitivanjima u kojima je Seroquel primjenjivan kao monoterapija, incidencija najmanje jedne pojave pomaka do broja neutrofila nižeg od 1,5 X 109/L, kod bolesnika koji su prije početka liječenja imali broj neutrofila ≥ 1,5 X 109/L, je bila 1,9% u skupini bolesnika koji su liječeni kvetiapinom u usporedbi s 1,5% kod bolesnika liječenih placebom.
Day 4 morning evening 25 mg 2x25 mg 100 mg 200 mg
25 mg 2x25 mg 100 mg 200 mg
The efficacy of Seroquel XR was further demonstrated with significance versus placebo in an additional 3 week study.
U dodatnom trotjednom ispitivanju je Seroquel XR pokazao značajnu razliku u djelotvornosti u odnosu na placebo.
In a 6-week, randomised, study of lithium and SEROQUEL XR versus placebo and SEROQUEL XR in adult patients with acute mania, the difference in YMRS mean improvement between the lithium add-on group and the placebo add-on group was 2.8 points and the difference in % responders (defined as 50% improvement from baseline on the YMRS) was 11% (79% in the lithium add-on group vs. 68% in the placebo add-on group).
naspram placeba i lijeka Seroquel XR u odraslih bolesnika s akutnom manijom, razlika u srednjoj vrijednosti poboljšanja rezultata na YMRS (Young Mania Rating Scale) ljestvici između skupine kojoj je dodavan litij i skupine kojoj je dodavan placebo iznosila je 2,8 bodova, a razlika u postotku bolesnika koji su odgovorili na liječenje (što je definirano kao poboljšanje za 50% od početnog rezultata na YMRS
QUALITATIVE AND QUANTITATIVE COMPOSITION Seroquel 25 mg contains 25 mg quetiapine (as quetiapine fumarate) Excipient : 18 mg lactose (anhydrous) per tablet
KVALITATIVNI I KVANTITATIVNI SASTAV Seroquel 25 mg sadržava 25 mg kvetiapina (u obliku kvetiapinfumarata).
If you forget to take a dose of Seroquel
Ako ste zaboravili uzeti Seroquel
In placebo-controlled studies in elderly patients with dementia-related psychosis, the incidence of cerebrovascular adverse events per 100 patient years was not higher in quetiapine-treated patients than in placebo-treated patients.
incidencija cerebrovaskularnih štetnih događaja na 100 bolesnik-godina nije bila viša u bolesnika liječenih kvetiapinom u odnosu na bolesnike koji su dobivali placebo.
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.
Pri primjeni neuroleptika zabilježeni su slučajevi produljenja QT-intervala, ventrikularnih aritmija, iznenadne neobjašnjive smrti, srčanog zastoja i aritmije poznate pod nazivom "torsades de pointes".
Based on shifts from normal baseline to potentially clinically important value at anytime post-baseline in all trials.
Temeljeno na pomaku sa normalnih početnih vrijednosti na potencijalno klinički važne vrijednosti u bilo kojem trenutku tijekom primjene lijeka u svim ispitivanjima.
100 mg/day; subsequently the dose was titrated to a target dose (mania 400-600 mg/day; schizophrenia 400-800 mg/day) using increments of 100 mg/day given two or three times daily.
primijenjeno dva ili tri puta dnevno do ciljane doze (manija 400-600 mg dnevno; shizofrenija 400-800 mg dnevno).
(27) Based on shifts from normal baseline to potentially clinically important value at anytime post-baseline in all trials.
27. Temeljeno na pomaku sa normalnih početnih vrijednosti na potencijalno klinički važne vrijednosti u bilo kojem trenutku tijekom primjene lijeka u svim ispitivanjima.
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.
mg/dnevno prvi, drugi i treći dan, a doza se mogla povećati na 100 mg/dnevno četvrti dan, na 150 mg/dnevno osmi dan i do 300 mg/dnevno ovisno o kliničkom odgovoru i podnošljivosti.
Fasting blood glucose ≥126 mg/dL (≥7.0 mmol/L) or a non fasting blood glucose ≥200 mg/dL (≥11.1 mmol/L) on at least one occasion.
Barem jednom izmjerena vrijednost glukoze u krvi natašte ≥ 126 mg/dL (≥ 7,0 mmol/L), ili barem jednom izmjerena vrijednost glukoze u krvi nakon uzimanja obroka ≥ 200 mg /dL (≥ 11,1 mmol/L).
The dose can be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the individual patient.
Doza se može povećavati za 50 mg dnevno do postizanja učinkovite doze, ovisno o kliničkom odgovoru i podnošljivosti kod pojedinog bolesnika.
Day 3 morning evening 25 mg 2x25 mg 100 mg
25 mg 2x25 mg 100 mg
Patients with hepatic impairment should be started on 50 mg/day.
U bolesnika s oštećenom funkcijom jetre, liječenje se mora započeti dozom od 50 mg dnevno.
Increases in triglycerides, LDL and total cholesterol, and decreases in HDL cholesterol have been observed in clinical trials with quetiapine (see section 4.8).
U kliničkim ispitivanjima kvetiapina primijećen je porast razine triglicerida, LDL-a i ukupnog kolesterola, te smanjenje razine HDL-kolesterola (vidjeti dio 4.8).
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).
Jezgra tablete: povidon, kalcijev hidrogenfosfat dihidrat, mikrokristalična celuloza, natrijev škroboglikolat vrste A, laktoza hidrat, magnezijev stearat.
Also caution should be exercised when quetiapine is prescribed either with medicines known to increase QT interval, or with concomitant neuroleptics, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia (see section 4.5).
Također je nužan oprez pri propisivanju kvetiapina s lijekovima za koje je poznato da produžuju QT interval te pri istodobnoj primjeni neuroleptika, naročito u starijih, u bolesnika: s kongenitalnim sindromom produljenog QT intervala, kongestivnim srčanim zatajenjem, hipertrofijom srca,
18 blisters of 10 tablets (150 mg and 300 mg tablets only)
18 blistera s 10 tableta (samo za tablete od 150 mg i 300 mg)
The symptoms of tardive dyskinesia can worsen or even arise after discontinuation of treatment (see Section 4.8).
Simptomi tardivne diskinezije mogu se pogoršati ili čak pojaviti nakon prestanka terapije
The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4).
Ukupna dnevna doza za prva četiri dana terapije iznosi kako slijedi: 100 mg (prvi dan), 200 mg (drugi dan), 300 mg (treći dan) i 400 mg (četvrti dan).
NAME OF THE MEDICINAL PRODUCT Seroquel 100 (or 150 mg, or 200 mg or 300 mg) mg film-coated tablets quetiapine
Seroquel 100 mg (ili 150 mg, ili 200 mg, ili 300 mg) filmom obložene tablete kvetiapin
Dry mouth
• začepljen nos
Elevations in serum alanine aminotransferas e (ALT)3, Elevatio ns in gammaGT levels3
Poremećaji jetre i žući povećanja razine alanin aminotransfer aze (ALT) u serumu3,
Constipation and intestinal obstruction have been reported with quetiapine (see section 4.8 Undesirable effects).
Konstipacija i opstrukcija crijeva prijavljene su kod primjene kvetiapina (vidjeti dio 4.8 Nuspojave).
Dyspnoea 23
disfagija7
See leaflet for further information.
Za daljnje informacije vidjeti Uputu o lijeku.
• Shortness of breath.
• nedostatak zraka
INFORMATION IN BRAILLE Seroquel 25 mg and 100 mg
16. PODACI NA BRAILLEOVOM PISMU Seroquel 25 mg i 100 mg
Respiratory, thoracic and mediastinal disorder
Poremećaji dišnog sustava, prsišta i sredoprsja dispneja rinitis
The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4).
Ukupna dnevna doza za prva četiri dana liječenja iznosi 50 mg (prvi dan), 100 mg (drugi dan), 200 mg (treći dan) i 300 mg (četvrti dan).
12 blisters of 10 tablets (150 mg and 300 mg tablets only)
12 blistera s 10 tableta (samo za tablete od 150 mg i 300 mg)
• Inflammation of the pancreas
• razdražljivost Prijavljivanje nuspojava
INFORMATION IN BRAILLE Seroquel 25 mg
16. PODACI NA BRAILLEOVOM PISMU Seroquel 25 mg
Calcium Hydrogen Phosphate Dihydrate Microcrystalline Cellulose Sodium Starch Glycolate Type A Lactose Monohydrate Magnesium Stearate
Jezgra povidon kalcijev hidrogenfosfat dihidrat celuloza, mikrokristalična natrijev škroboglikolat, vrste A laktoza hidrat magnezijev stearat
Therefore, Seroquel XR should be used with caution in patients with known hepatic impairment, especially during the initial dosing period.
Kvetiapin se opsežno metabolizira u jetri te se stoga Seroquel XR mora s oprezom davati bolesnicima s poznatim oštećenjem funkcije jetre, naročito tijekom početnog razdoblja doziranja.
100 film-coated tablets
100 filmom obloženih tableta
Seroquel was administered twice-daily totalling 400 mg to 800 mg a day as combination therapy to lithium or valproate.
Seroquel je davan kao kombinirano liječenje s litijem ili valproatom dvaput dnevno u ukupnoj dozi od 400 mg do 800 mg na dan.
For the treatment of moderate to severe manic episodes in bipolar disorder For the treatment of manic episodes associated with bipolar disorder, Seroquel should be administered twice a day.
Za liječenje maničnih epizoda povezanih s bipolarnim poremećajem, Seroquel je potrebno uzimati dva puta dnevno.
If you do, your doctor may check your blood sugar levels while you are taking Seroquel XR.
U tom slučaju, tijekom liječenja Seroquelom XR liječnik Vam može provjeravati razinu šećera u krvi.
PACKAGE LEAFLET
Sadržaj pakiranja
Very Common side effects (may affect more than 1 in 10 people):
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava smanjena razina hemoglobina22
Platelets ≤100 x 109/L on at least one occasion 14.
13. Barem jednom izmjerena vrijednost trombocita ≤ 100 x 109/L 14.
Constipation and intestinal obstruction
Konstipacija i opstrukcija crijeva
Seroquel XR dose can be adjusted depending on clinical response and tolerability of the individual patient within the dose range of 300 mg to 800 mg/day.
Doza Seroquela XR se može prilagoditi u rasponu od 300 mg do 800 mg dnevno, ovisno o kliničkom odgovoru i podnošljivosti kod pojedinog bolesnika.
Treatment with quetiapine should be reassessed in patients with suspected cardiomyopathy or myocarditis.
U bolesnika u kojih se sumnja na kardiomiopatiju ili miokarditis treba ponovno procijeniti liječenje kvetiapinom.
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. Razina prolaktina (bolesnici > 18 godina) u bilo kojem trenutku: > 20µg/L (> 869,56 pmol/L) muškarci; >
Seroquel XR 50 mg prolonged-release tablets Seroquel XR 150 mg prolonged-release tablets Seroquel XR 200 mg prolonged-release tablets Seroquel XR 300 mg prolonged-release tablets Seroquel XR 400 mg prolonged-release tablets
Seroquel XR 50 mg tablete s produljenim oslobađanjem Seroquel XR 150 mg tablete s produljenim oslobađanjem Seroquel XR 200 mg tablete s produljenim oslobađanjem Seroquel XR 300 mg tablete s produljenim oslobađanjem Seroquel XR 400 mg tablete s produljenim oslobađanjem
Musculoskeletal and connective tissue disorders
Poremećaji mišićno koštanog sustava i vezivnog tkiva rabdomioliza
Quetiapine was administered twice-daily totalling 400 mg to 800 mg a day as combination therapy to lithium or valproate.
Kvetiapin je davan kao kombinirana terapija s litijem ili valproatom dvaput dnevno u ukupnoj dozi od 400 mg do 800 mg na dan.
Seroquel 25 mg film-coated tablets are peach coloured, round biconvex and engraved with SEROQUEL 25 on one side
Seroquel 25 mg filmom obložene tablete su boje breskve, okrugle bikonveksne, a na jednoj njihovoj strani utisnuta je oznaka "SEROQUEL 25".
10 film-coated tablets
10 filmom obloženih tableta
• Keep this medicine out of the reach and sight of children.
Kako čuvati Seroquel • Ovaj lijek čuvajte izvan dohvata i pogleda djece.
• A long-lasting and painful erection (Priapism).
• upala jetre (hepatitis) • dugotrajna i bolna erekcija (prijapizam)
What Seroquel XR is and what it is used for What you need to know before you take Seroquel XR How to take Seroquel XR
Što je Seroquel XR i za što se koristi Seroquel XR sadrži djelatnu tvar kvetiapin.
NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg and 100 mg tablets quetiapine
NAZIV LIJEKA Seroquel 25 mg i 100 mg tablete kvetiapin
In a clinical trial, in patients with depressive episodes in bipolar I or bipolar II disorder, 300 mg/day Seroquel XR showed superior efficacy to placebo in reduction of MADRS total score.
I poremećaju ili bipolarnom II poremećaju, dnevne doze od 300 mg Seroquela XR su pokazale superiornu djelotvornost u redukciji ukupnog MADRS (Montgomery Åsberg Depression Rating Scale) zbroja bodova u odnosu na placebo.
Film-coated tablet
Filmom obložena tableta.
Seroquel 200 mg film-coated tablets are white, round biconvex and engraved with SEROQUEL 200 on one side
Seroquel 200 mg filmom obložene tablete su bijele boje, okrugle bikonveksne, a na jednoj njihovoj strani utisnuta je oznaka "SEROQUEL 200".
• Difficulty in passing urine.
• poteškoće s gutanjem
1 blister of 10 tablets
1 blister s 10 tableta
50 film-coated tablets
50 filmom obloženih tableta
Therefore, Seroquel should be used with caution in patients with known hepatic impairment, especially during the initial dosing period.
Kvetiapin se opsežno metabolizira u jetri, te se stoga Seroquel mora s oprezom davati bolesnicima s poznatim oštećenjem funkcije jetre, naročito tijekom početnog razdoblja doziranja.
Children and Adolescents Seroquel XR is not for use in children and adolescents below 18 years of age.
Seroquel XR nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
<[See Annex I - To be completed nationally]> [For referral procedures, as appropriate] This leaflet was last approved in {MM/YYYY}.
<[Vidjeti Dodatak I - Ispunjava država članica]>
(16) May lead to falls.
Može uzrokovati padove.
Renal Impairment
Jetrene tegobe
Seroquel 100 mg film-coated tablets are yellow, round biconvex and engraved with SEROQUEL 100 on one side
Seroquel 100 mg filmom obložene tablete su žute boje, okrugle bikonveksne, a na jednoj njihovoj strani utisnuta je oznaka "SEROQUEL 100".
Seroquel 150 mg film-coated tablets are pale yellow, round biconvex and engraved with SEROQUEL 150 on one side
Seroquel 150 mg filmom obložene tablete su svijetložute boje, okrugle bikonveksne, a na jednoj njihovoj strani utisnuta je oznaka "SEROQUEL 150".
Weight gain
Tjelesna težina
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg (or 150 mg, or 200 mg or 300 mg) quetiapine (as fumarate)
Jedna tableta sadrži 100 mg (ili 150 mg, ili 200 mg, ili 300 mg) kvetiapina (u obliku kvetiapinfumarata).
10 blisters of 5 tablets
10 blistera s 5 tableta
Elevatio ns in gammaGT levels
povećanja razine gamaGT
Ferric Oxide, Yellow (E172) 25 mg, 100 mg and 150 mg tablets) Ferric Oxide, Red (E172) (25 mg tablets)
Ovojnica hipromeloza 2910 makrogol 400 titanijev dioksid (E 171) željezov oksid, žuti (E 172) (tablete od 25 mg, 100 mg i 150 mg) željezov oksid, crveni (E 172) (tablete od 25 mg)
In 4 additional clinical trials with quetiapine, 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.
I ili bipolarnom poremećaju tipa II, Seroquel tablete s trenutnim oslobađanjem od 300 mg i 600 mg su se pokazale značajno superiornije od placeba u relevantnim mjerama ishoda: srednjem poboljšanju na MADRS (Montgomery Åsberg Depression Rating Scale) ljestvici i odgovoru definiranom kao najmanje 50% poboljšanja u ukupnom MADRS zbroju bodova u odnosu na početni rezultat.
INFORMATION IN BRAILLE Seroquel XR 200 mg
16. PODACI NA BRAILLEOVOM PISMU Seroquel XR 200 mg
Treatment with Seroquel was initiated at 50 mg/day and on day 2 increased to
Liječenje Seroquelom započeto je dozom od 50 mg dnevno, drugi dan doza je povišena na 100 mg dnevno te je dalje titrirana povećanjem od 100 mg na dan,
5 blisters of 10 tablets
5 blistera s 10 tableta
INFORMATION IN BRAILLE Seroquel XR 150 mg
16. PODACI NA BRAILLEOVOM PISMU Seroquel XR 150 mg
Quetiapine is well absorbed following oral administration.
Nakon peroralne primjene, kvetiapin se dobro apsorbira.
What Seroquel is and what it is used for What you need to know before you take Seroquel How to take Seroquel
Što je Seroquel i za što se koristi Seroquel sadrži djelatnu tvar kvetiapin.
Thrombocytope nia, Anaemia, platelet count decreased
povećana razina eozinofila trombocitopenija, anemija, smanjen broj trombocita agranulocitoza neutropenija
Do not take Seroquel if the above applies to you.
Ako se bilo što od gore navedenoga odnosi na Vas, nemojte uzimati Seroquel.
Povidone
Napadaji
Seroquel XR tablets contain 50 mg, 150 mg, 200 mg, 300 mg or
Seroquel XR tablete sadrže 50 mg, 150 mg, 200 mg, 300 mg ili 400 mg kvetiapina (u obliku kvetiapinfumarata).
Prolactin levels (patients < 18 years of age): >20 ug/L (>869.56 pmol/L) males; >26 ug/L (>1130.428 pmol/L) females at any time.
15. Razina prolaktina (bolesnici> 18 godina u bilo kojem trenutku): > 20µg/L (> 869,56 pmol/L) muškarci; >
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%
12,9% naspram 5,3% u ispitivanju u shizofreniji, 3,6% naspram 1,1% u ispitivanju u bipolarnoj maniji te
NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg film-coated tablets quetiapine
Seroquel 25 mg filmom obložene tablete kvetiapin
Priapism, galactorrhoea, breast swelling, menstrual disorder
Poremećaji reproduktivnog sustava i dojki seksualna disfunkcija prijapizam, galaktoreja, oticanje dojki, menstrualni poremećaj
• Sexual dysfunction.
• liječenje shizofrenije.
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).
Kombinacija sa Seroquelom se pokazala superiornijom u odnosu na monoterapiju stabilizatorima raspoloženja u povećanju vremena do ponovnih pojava bilo koje epizode (manične, mješovite ili depresivne).
9 blisters of 10 tablets
9 blistera s 10 tableta
Use in children and adolescents Seroquel XR should not be used by children and adolescents aged under 18 years.
Seroquel XR ne smiju koristiti djeca i adolescenti mlađi od 18 godina.
2 blisters of 10 tablets
2 blistera s 10 tableta
Leucopenia decreased neutrophil count, eosinophils increased27
leukopenija 28, smanjen broj neutrofila,
Each tablet contains 200 mg quetiapine (as fumarate)
Jedna tableta sadrži 200 mg kvetiapina (u obliku kvetiapinfumarata).
Children and Adolescents Seroquel is not for use in children and adolescents below 18 years of age.
Seroquel nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg, 100 mg and 200 mg tablets quetiapine
Seroquel 25 mg, 100 mg i 200 mg tablete kvetiapin
INFORMATION IN BRAILLE Seroquel XR 400 mg
16. PODACI NA BRAILLEOVOM PISMU Seroquel XR 400 mg