FrancophonIA/ELRC3.0 huggingface dataset:
English: Seroquel 25 mg film-coated tablets are peach coloured, round biconvex and engraved with SEROQUEL 25 on one side
Croatian: Seroquel 25 mg filmom obložene tablete su boje breskve, okrugle bikonveksne, a na jednoj njihovoj strani utisnuta je oznaka "SEROQUEL 25".
English: 10 film-coated tablets
Croatian: 10 filmom obloženih tableta
English: • Keep this medicine out of the reach and sight of children.
Croatian: Kako čuvati Seroquel • Ovaj lijek čuvajte izvan dohvata i pogleda djece.
English: • A long-lasting and painful erection (Priapism).
Croatian: • upala jetre (hepatitis) • dugotrajna i bolna erekcija (prijapizam)
English: 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
Croatian: Što je Seroquel XR i za što se koristi Seroquel XR sadrži djelatnu tvar kvetiapin.
English: NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg and 100 mg tablets quetiapine
Croatian: NAZIV LIJEKA Seroquel 25 mg i 100 mg tablete kvetiapin
English: 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.
Croatian: 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.
English: Film-coated tablet
Croatian: Filmom obložena tableta.
English: Seroquel 200 mg film-coated tablets are white, round biconvex and engraved with SEROQUEL 200 on one side
Croatian: Seroquel 200 mg filmom obložene tablete su bijele boje, okrugle bikonveksne, a na jednoj njihovoj strani utisnuta je oznaka "SEROQUEL 200".
English: • Difficulty in passing urine.
Croatian: • poteškoće s gutanjem
English: 1 blister of 10 tablets
Croatian: 1 blister s 10 tableta
English: 50 film-coated tablets
Croatian: 50 filmom obloženih tableta
English: Therefore, Seroquel should be used with caution in patients with known hepatic impairment, especially during the initial dosing period.
Croatian: 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.
English: Children and Adolescents Seroquel XR is not for use in children and adolescents below 18 years of age.
Croatian: Seroquel XR nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
English: <[See Annex I - To be completed nationally]> [For referral procedures, as appropriate] This leaflet was last approved in {MM/YYYY}.
Croatian: <[Vidjeti Dodatak I - Ispunjava država članica]>
English: (16) May lead to falls.
Croatian: Može uzrokovati padove.
English: Renal Impairment
Croatian: Jetrene tegobe
English: Seroquel 100 mg film-coated tablets are yellow, round biconvex and engraved with SEROQUEL 100 on one side
Croatian: Seroquel 100 mg filmom obložene tablete su žute boje, okrugle bikonveksne, a na jednoj njihovoj strani utisnuta je oznaka "SEROQUEL 100".
English: Seroquel 150 mg film-coated tablets are pale yellow, round biconvex and engraved with SEROQUEL 150 on one side
Croatian: Seroquel 150 mg filmom obložene tablete su svijetložute boje, okrugle bikonveksne, a na jednoj njihovoj strani utisnuta je oznaka "SEROQUEL 150".
English: Weight gain
Croatian: Tjelesna težina
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg (or 150 mg, or 200 mg or 300 mg) quetiapine (as fumarate)
Croatian: Jedna tableta sadrži 100 mg (ili 150 mg, ili 200 mg, ili 300 mg) kvetiapina (u obliku kvetiapinfumarata).
English: 10 blisters of 5 tablets
Croatian: 10 blistera s 5 tableta
English: Elevatio ns in gammaGT levels
Croatian: povećanja razine gamaGT
English: Ferric Oxide, Yellow (E172) 25 mg, 100 mg and 150 mg tablets) Ferric Oxide, Red (E172) (25 mg tablets)
Croatian: 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)
English: 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.
Croatian: 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.
English: INFORMATION IN BRAILLE Seroquel XR 200 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Seroquel XR 200 mg
English: Treatment with Seroquel was initiated at 50 mg/day and on day 2 increased to
Croatian: 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,
English: 5 blisters of 10 tablets
Croatian: 5 blistera s 10 tableta
English: INFORMATION IN BRAILLE Seroquel XR 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Seroquel XR 150 mg
English: Quetiapine is well absorbed following oral administration.
Croatian: Nakon peroralne primjene, kvetiapin se dobro apsorbira.
English: What Seroquel is and what it is used for What you need to know before you take Seroquel How to take Seroquel
Croatian: Što je Seroquel i za što se koristi Seroquel sadrži djelatnu tvar kvetiapin.
English: Thrombocytope nia, Anaemia, platelet count decreased
Croatian: povećana razina eozinofila trombocitopenija, anemija, smanjen broj trombocita agranulocitoza neutropenija
English: Do not take Seroquel if the above applies to you.
Croatian: Ako se bilo što od gore navedenoga odnosi na Vas, nemojte uzimati Seroquel.
English: Povidone
Croatian: Napadaji
English: Seroquel XR tablets contain 50 mg, 150 mg, 200 mg, 300 mg or
Croatian: Seroquel XR tablete sadrže 50 mg, 150 mg, 200 mg, 300 mg ili 400 mg kvetiapina (u obliku kvetiapinfumarata).
English: 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.
Croatian: 15. Razina prolaktina (bolesnici> 18 godina u bilo kojem trenutku): > 20µg/L (> 869,56 pmol/L) muškarci; >
English: 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%
Croatian: 12,9% naspram 5,3% u ispitivanju u shizofreniji, 3,6% naspram 1,1% u ispitivanju u bipolarnoj maniji te
English: NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg film-coated tablets quetiapine
Croatian: Seroquel 25 mg filmom obložene tablete kvetiapin
English: Priapism, galactorrhoea, breast swelling, menstrual disorder
Croatian: Poremećaji reproduktivnog sustava i dojki seksualna disfunkcija prijapizam, galaktoreja, oticanje dojki, menstrualni poremećaj
English: • Sexual dysfunction.
Croatian: • liječenje shizofrenije.
English: 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).
Croatian: 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).
English: 9 blisters of 10 tablets
Croatian: 9 blistera s 10 tableta
English: Use in children and adolescents Seroquel XR should not be used by children and adolescents aged under 18 years.
Croatian: Seroquel XR ne smiju koristiti djeca i adolescenti mlađi od 18 godina.
English: 2 blisters of 10 tablets
Croatian: 2 blistera s 10 tableta
English: Leucopenia decreased neutrophil count, eosinophils increased27
Croatian: leukopenija 28, smanjen broj neutrofila,
English: Each tablet contains 200 mg quetiapine (as fumarate)
Croatian: Jedna tableta sadrži 200 mg kvetiapina (u obliku kvetiapinfumarata).
English: Children and Adolescents Seroquel is not for use in children and adolescents below 18 years of age.
Croatian: Seroquel nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
English: NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg, 100 mg and 200 mg tablets quetiapine
Croatian: Seroquel 25 mg, 100 mg i 200 mg tablete kvetiapin
English: INFORMATION IN BRAILLE Seroquel XR 400 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Seroquel XR 400 mg
English: How to store Seroquel
Croatian: Moguće nuspojave Kako čuvati Seroquel
English: Dysarthria
Croatian: Disfagija
English: Each tablet contains 400 mg quetiapine (as fumarate)
Croatian: Jedna tableta sadrži 400 mg kvetiapina (u obliku kvetiapinfumarata).
English: INFORMATION IN BRAILLE Seroquel XR 50 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Seroquel XR 50 mg
English: Each tablet contains 300 mg quetiapine (as fumarate)
Croatian: Jedna tableta sadrži 300 mg kvetiapina (u obliku kvetiapinfumarata).
English: • A long-lasting and painful erection (priapism).
Croatian: • dugotrajnu i bolnu erekciju (prijapizam)
English: Drug withdrawal syndrome neonatal31
Croatian: babinje i perinatalno razdoblje sindrom ustezanja kod novorođenčadi31
English: 6 blisters of 10 tablets
Croatian: 6 blistera s 10 tableta
English: The 25 mg, 100 mg and 150 mg tablet also contain iron oxide yellow (E172) and the 25 mg contain iron oxide red (E172).
Croatian: 150 mg također sadrže žuti željezov oksid (E 172), a tablete od 25 mg sadrže i crveni željezov oksid
English: Each tablet contains 150 mg quetiapine (as fumarate)
Croatian: Jedna tableta sadrži 150 mg kvetiapina (u obliku kvetiapinfumarata).
English: (See also section 4.5)
Croatian: (vidjeti i dio 4.8).
English: Seroquel 150 mg contains 150 mg quetiapine (as quetiapine fumarate) Excipient : 29 mg lactose (anhydrous) per tablet
Croatian: Seroquel 150 mg sadržava 150 mg kvetiapina (u obliku kvetiapinfumarata).
English: Seroquel XR 150 mg and 300 mg/day, given as add-on treatment to ongoing antidepressant therapy (amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline or venlafaxine) demonstrated superiority over antidepressant therapy alone in reducing depressive symptoms as measured by improvement in MADRS total score (LS mean change vs. placebo of 2-3.3 points).
Croatian: Seroquel XR 150 mg i 300 mg/dnevno, primijenjen kao dodatna terapija uz postojeću terapiju antidepresivima (amitriptilin, bupropion, citalopram, duloksetin, escitalopram,
English: NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg, 100 mg and 200 mg film-coated tablets quetiapine
Croatian: Seroquel 25 mg, 100 mg i 200 mg filmom obložene tablete kvetiapin
English: • If you are taking any of the following medicines: - some medicines for HIV - azole medicines (for fungal infections) - erythromycin or clarithromycin (for infections) - nefazodone (for depression)
Croatian: - neke lijekove kojima se liječi HIV - lijekove iz skupine azola (za suzbijanje gljivičnih infekcija)
English: (13) Platelets ≤100 x 10
Croatian: 13. Barem jednom izmjerena vrijednost trombocita ≤ 100 x 109/L
English: • Bowel obstruction.
Croatian: • upala gušterače.
English: 10 blisters of 10 tablets
Croatian: 10 blistera s 10 tabletsa
English: For patients who were randomized to placebo, the mean weight gain during the open label period was 2.39 kg, and by week 48 of the randomized period the mean weight gain was 0.89 kg, compared to open label baseline.
Croatian: Za bolesnike koji su randomizirani u skupinu s placebom srednji dobitak na težini tijekom otvorenog razdoblja ispitivanja bio je 2,39 kg, a do
English: Iron oxide, yellow (E172) (50, 200 and 300 mg tablets) Iron oxide, red (E172) (50 mg tablets) 6.2 Incompatibilities
Croatian: Ovojnica hipromeloza 2910 makrogol 400 titanijev dioksid (E 171) željezov oksid, žuti (E 172) (tablete od 50 mg, 200 mg i 300 mg) željezov oksid, crveni (E 172) (tablete od 50 mg).
English: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension.
Croatian: Kvetiapin se mora davati s oprezom bolesnicima za koje je poznato da imaju kardiovaskularne bolesti,
English: Seroquel XR 200 mg prolonged-release tablets quetiapine
Croatian: Seroquel XR 200 mg tablete s produljenim oslobađanjem kvetiapin
English: Renal Impairment: Dosage adjustment is not necessary in patients with renal impairment.
Croatian: U bolesnika s oštećenom funkcijom bubrega nije potrebna prilagodba doze.
English: Reproductive system and breast disorders
Croatian: Poremećaji bubrega i mokraćnog sustava retencija mokraće
English: INFORMATION IN BRAILLE Seroquel XR 300 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Seroquel XR 300 mg
English: Use in children and adolescents Seroquel should not be used by children and adolescents aged under 18 years.
Croatian: Seroquel ne smiju koristiti djeca i adolescenti mlađi od 18 godina.
English: Seroquel 100 mg contains 100 mg quetiapine (as quetiapine fumarate) Excipient : 20 mg lactose (anhydrous) per tablet
Croatian: Seroquel 100 mg sadržava 100 mg kvetiapina (u obliku kvetiapinfumarata).
English: The frequencies of adverse events are ranked according to the following: Very common (≥1/10), common
Croatian: Nuspojave povezane s liječenjem kvetiapinom Učestalost nuspojava klasificirana je na sljedeći način: vrlo često (>1/10), često (>1/100 i <1/10),
English: Seroquel XR 150 mg prolonged-release tablets quetiapine
Croatian: Seroquel XR 150 mg tablete s produljenim oslobađanjem kvetiapin
English: Seroquel 200 mg contains 200 mg quetiapine (as quetiapine fumarate) Excipient : 39 mg lactose (anhydrous) per tablet
Croatian: Seroquel 200 mg sadržava 200 mg kvetiapina (u obliku kvetiapinfumarata).
English: Gradual withdrawal over a period of at least one to two weeks is advisable.
Croatian: Preporuča se postupno prekidanje uzimanja lijeka tijekom perioda od najmanje jednog do dva tjedna (vidjeti dio 4.8.).
English: Each tablet contains 50 mg quetiapine (as fumarate)
Croatian: Jedna tableta sadrži 50 mg kvetiapina (u obliku kvetiapinfumarata).
English: o Men and women to have swelling of breasts and unexpectedly produce breast milk.
Croatian: • oticanje dojki i neočekivano izlučivanje mlijeka iz dojki kod muškaraca i žena.
English: How to store Seroquel XR
Croatian: Moguće nuspojave Kako čuvati Seroquel XR
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL 3-Day starter pack
Croatian: FOLIJA BLISTERA 3-dnevno početno pakiranje
English: • If you get any side effects talk to your doctor or pharmacist.This includes any side effects not listed in this leaflet.
Croatian: Navedeni učinci se smatraju svojstvenima svim lijekovima ove farmakološke skupine (učinak klase), a ne nekom njezinom pojedinačnom predstavniku.
English: 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).
Croatian: Provedena su dva ispitivanja u kojima se procjenjivao kvetiapin korišten u kombinaciji sa stabilizatorima raspoloženja u svrhu sprječavanja ponovne pojave bolesti, u bolesnika s maničnim, depresivnim ili mješovitim epizodama.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL 4-Day starter pack
Croatian: FOLIJA BLISTERA 4-dnevno početno pakiranje
English: Seroquel XR 50 mg prolonged-release tablets quetiapine
Croatian: Seroquel XR 50 mg tablete s produljenim oslobađanjem kvetiapin
English: Seroquel XR 300 mg prolonged-release tablets quetiapine
Croatian: Seroquel XR 300 mg tablete s produljenim oslobađanjem kvetiapin
English: 3 blisters of 10 tablets
Croatian: 3 blistera s 10 tableta
English: Seizures:
Croatian: Spol:
English: Seroquel 300 mg contains 300 mg quetiapine (as quetiapine fumarate) Excipient : 59 mg lactose (anhydrous) per tablet
Croatian: Seroquel 300 mg sadržava 300 mg kvetiapina (u obliku kvetiapinfumarata).
English: Seroquel XR 400 mg prolonged-release tablets quetiapine
Croatian: Seroquel XR 400 mg tablete s produljenim oslobađanjem kvetiapin
English: Tardive Dyskinesia:
Croatian: ROK VALJANOSTI Rok valjanosti:
English: Cataracts/lens opacities
Croatian: Katarakta / zamućenje leće
English: If you take more Seroquel than prescribed by your doctor, you may feel sleepy, feel dizzy and experience abnormal heart beats.
Croatian: Vam je propisao liječnik, možete osjetiti pospanost, omaglicu i nepravilne otkucaje srca.
English: Agranulocytosis26
Croatian: povećanja razine TSH24
English: Seroquel tablets contain 25 mg, 100 mg, 150 mg, 200 mg or
Croatian: Seroquel tablete sadrže 25 mg, 100 mg, 150 mg,200 mg ili 300 mg kvetiapina (u obliku kvetiapinfumarata).
English: SOC
Croatian: U
English: At steady-state, the dosenormalized plasma levels of the parent compound, quetiapine, in children and adolescents (10-17 years of age) were in general similar to adults, though Cmax in children was at the higher end of the range observed in adults.
Croatian: (10-17 godina) uglavnom je bila slična onoj u odraslih, iako je Cmax u djece bio na gornjoj granici raspona zabilježenog u odraslih.
English: Macrogol 400
Croatian: P450.
English: NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg and 100 mg film-coated tablets quetiapine
Croatian: Seroquel 25 mg i 100 mg filmom obložene tablete kvetiapin
English: 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.
Croatian: 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 ljestvici i odgovoru definiranom kao najmanje 50% poboljšanja u ukupnom MADRS zbroju bodova u odnosu na početni rezultat.
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Croatian: Povećanje tjelesne težine je bilo prijavljeno kod bolesnika koji su liječeni kvetiapinom, i mora se nadzirati i zbrinjavati kako je klinički prikladno, u skladu sa smjernicama za primjenu antipsihotika (vidjeti dijelove
English: 4 See section 5.1
Croatian: 4.8 i 5.1).
English: Dizziness 4, 16, somnolence headache, Extrapyramidal symptoms1, 21
Croatian: Poremećaji živčanog sustava omaglica somnolencija2, 16, glavobolja, ekstrapiramidni simptomi dizartrija
English: • If you are taking any of the following medicines: o some medicines for HIV o azole medicines (for fungal infections) o erythromycin or clarithromycin (for infections) o nefazodone (for depression).
Croatian: • neke lijekove za liječenje HIV-a, • lijekove iz skupine azola (za suzbijanje gljivičnih infekcija),
English: 9/L on at least one occasion (14) Based on clinical trial adverse event reports of blood creatine phosphokinase increase not associated with neuroleptic malignant syndrome (15) 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.
Croatian: Opći poremećaji i reakcije na mjestu primjene razdražljivost3 Razina prolaktina (bolesnici < 18 godina) u bilo kojem trenutku: > 20 µg/L (> 869,56 pmol/L) muškarci; > 26
English: Endocrine disorders
Croatian: Organski sustav
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): • napadaji
English: Seroquel 300 mg film-coated tablets are white, capsule-shaped and engraved with SEROQUEL on one side and 300 on the other side
Croatian: Seroquel 300 mg filmom obložene tablete su bijele boje, u obliku kapsule.
English: Rhinitis
Croatian: Cipar
English: • Fits (seizures).
Croatian: Area Under Curve).
English: Renal and urinary disorders
Croatian: prsišta i sredoprsja rinitis
English: Seroquel Depot United Kingdom Seroquel XL
Croatian: Seroquel XL
English: Hyponatraemia 19, Diabetes Mellitus
Croatian: Krvožilni poremećaji ortostatska hipotenzija4, 16
English: Quetiapine exhibits minimal dystonic liability in haloperidol-sensitised or drug-naive Cebus monkeys after acute and chronic administration.
Croatian: Ograničeni su podaci o primjeni kvetiapina u kombinaciji s divalproeksom ili litijem u akutnom liječenju umjerenih do teških maničnih epizoda.
English: 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.
Croatian: godina) bila je 2,1% (3/144) za kvetiapin i 1,3% (1/75) za placebo.
English: The usual effective dose is in the range of 400 to 800 mg/day.
Croatian: Uobičajena učinkovita doza se kreće u rasponu od 400
English: The pharmacokinetics of quetiapine and norquetiapine are linear and dose-proportional for doses up to 800 mg administered once daily.
Croatian: Pri primjeni lijeka u jednokratnim dnevnim dozama do najviše 800 mg, farmakokinetika kvetiapina i norkvetiapina linearna je i razmjerna dozi.
English: Responder rates (YMRS improvement ≥50%) were 64% for Seroquel 400 mg/day, 58% for 600 mg/day and 37% in the placebo arm.
Croatian: Stopa odgovora (YMRS poboljšanje ≥ 50%) bila je 64% za Seroquel 400
English: This summary was last updated in 11-2014.
Croatian: Ovaj sažetak je posljednji put ažuriran u 11.2014.
English: In addition, Trulicity has the advantage of being given once a week.
Croatian: Nadalje, Trulicity ima prednost primjene jednom tjedno.
English: Trulicity dulaglutide
Croatian: Trulicity dulaglutid
English: Information from a sixth study that was submitted during the procedure was also considered.
Croatian: U obzir su uzete i informacije iz šestog ispitivanja koje su dostavljene tijekom postupka.
English: The full EPAR and risk management plan summary for Trulicity can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Trulicity nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trulicity on 21 November 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Trulicity na snazi u Europskoj uniji od 21. studenog 2014.
English: Other information about Trulicity
Croatian: Ostale informacije o lijeku Trulicity
English: This is a summary of the European public assessment report (EPAR) for Trulicity.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Trulicity.
English: With respect to safety, effects of longer term use and safety in vulnerable groups such as the very elderly would need to be monitored, but there were no specific areas of major concern and the risks were considered similar to those of other medicines in its class.
Croatian: Vezano uz sigurnu primjenu, djelovanje dugoročne primjene i sigurnost u osjetljivih skupina poput primjerice vrlo starih osoba potrebno je pratiti, no nema specifičnih područja veće zabrinutosti, a zaključeno je da su rizici slični onima drugih lijekova iste klase.
English: It is not intended to provide practical advice on how to use Trulicity.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Trulicity.
English: Why is Trulicity approved?
Croatian: Zašto je Trulicity odobren?