FrancophonIA/ELRC3.0 huggingface dataset:
English: • Lung infection
Croatian: • Infekcija pluća
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib plus dexamethasone; OS = overall survival; mo = months; HR = hazard ratio; CI = confidence interval
Croatian: Kd = Kyprolis i deksametazon; Vd = bortezomib i deksametazon; OS = sveukupno preživljenje; mj = mjeseci; HR = omjer hazarda; CI = interval pouzdanosti
English: Stop Kyprolis for grade 3 and 4 dyspnoea until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see sections 4.2 and 4.8).
Croatian: Prekinite primjenu lijeka Kyprolis u slučaju dispneje 3. ili 4. stupnja do oporavka ili povratka na početno stanje i razmotrite ponovnu primjenu lijeka Kyprolis s obzirom na procjenu omjera koristi i rizika (vidjeti dijelove 4.2 i 4.8).
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion Kyprolis 30 mg powder for solution for infusion Kyprolis 60 mg powder for solution for infusion
Croatian: Kyprolis 10 mg prašak za otopinu za infuziju Kyprolis 30 mg prašak za otopinu za infuziju Kyprolis 60 mg prašak za otopinu za infuziju
English: No starting dose adjustment is recommended in patients with mild or moderate hepatic impairment based on available pharmacokinetic data.
Croatian: Na temelju dostupnih farmakokinetičkih podataka, ne preporučuje se prilagodba početne doze u bolesnika s blagim ili umjerenim oštećenjem jetre.
English: Pulmonary haemorrhage Interstitial lung disease
Croatian: Intersticijska bolest puća Pneumonitis
English: 25 mg daily a. Infusion time is 10 minutes and remains consistent throughout the regimen
Croatian: Trajanje infuzije je 10 minuta i ne mijenja se tijekom režima
English: • Cataract
Croatian: • Katarakta
English: Influenza like illness Malaise
Croatian: Reakcije na mjestu primjene infuzije Bolest slična gripi Malaksalost
English: In patients refractory to lenalidomide (25%), median PFS was 8.6 months in the Kd arm versus 6.6 months in the Vd arm (HR = 0.80, 95% CI: 0.57, 1.11), ORR was 61.9% versus 54.9%.
Croatian: PFS-a bio je 8,6 mjeseci za Kd skupinu naspram 6,6 mjeseci za Vd skupinu (HR = 0,80, 95% CI: 0,57, 1,11), vrijednost ORR bila je 61,9% naspram 54,9%.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10 mg of carfilzomib.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka bočica sadrži 10 mg karfilzomiba.
English: Summary of efficacy analysis in relapsed multiple myeloma study PX-171-009 KRd combination therapy KRd arma (N = 396)
Croatian: Tablica 6. Sažetak analize djelotvornosti u ispitivanju recidivirajućeg multiplog mijeloma PX-171-009
English: • Low platelets, which may cause easy bruising or bleeding (thrombocytopenia)
Croatian: • Niska razina trombocita, što može uzrokovati lako stvaranje modrica ili krvarenje
English: Patients in the KRd arm had a 21% reduction in the risk of death compared with those in the Rd arm (HR = 0.79; 95% CI: 0.67, 0.95; p value = 0.0045).
Croatian: Statistički značajna prednost u ukupnom preživljenju (OS) opažena je u skupini KRd u usporedbi sa skupinom Rd. Bolesnici uključeni u skupinu KRd imali su 21% smanjen rizik od smrti u usporedbi s onima uključenima u skupinu Rd (HR = 0,79; 95% CI: 0,67; 0,95; p-vrijednost = 0,0045).
English: Gastrointestinal disorders
Croatian: Gastrointestinalno krvarenje
English: Pulmonary hypertension has been reported in patients treated with Kyprolis.
Croatian: U bolesnika liječenih lijekom Kyprolis prijavljeni su slučajevi plućne hipertenzije.
English: See the end of section 4 for how to report side effects.
Croatian: Pogledajte 'Stanja na koja trebate obratiti pozornost' u dijelu 4.
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib plus dexamethasone; PFS = progression-free survival; mo = months; HR = hazard ratio; CI = confidence interval
Croatian: Kd = Kyprolis i deksametazon; Vd = bortezomib i deksametazon; PFS = preživljenje bez progresije bolesti; mj = mjeseci; HR = omjer hazarda; CI = interval pouzdanosti
English: Kyprolis 60 mg powder for solution for infusion
Croatian: Kyprolis 60 mg prašak za otopinu za infuziju
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 60 mg of carfilzomib.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka bočica sadrži 60 mg karfilzomiba.
English: • Blood clot in the lungs
Croatian: • Krvni ugrušci u plućima
English: Kyprolis in combination with dexamethasone
Croatian: Kyprolis u kombinaciji s deksametazonom
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib and dexamethasone; CI = confidence interval; NE = not estimable; HR = Hazard Ratio; ORR = overall response rate; CR = complete response; VGPR = very good partial response a. These endpoints were determined by an Independent Review Committee b. Statistically significant c. Overall response is defined as achieving a best overall response of PR, VGPR, CR, or sCR d. Statistically significant, 1-sided p value = 0.0005 e. Statistically significant, 1-sided p value = 0.0001
Croatian: Kd = Kyprolis i deksametazon; Vd = bortezomib i deksametazon; CI = interval pouzdanosti; NP = nije procjenjivo; HR = omjer hazarda; ORR = ukupna stopa odgovora; CR = potpuni odgovor; VGPR = vrlo dobar djelomični odgovor a.
English: In case of hypertensive crises, stop Kyprolis until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Croatian: U slučaju hipertenzivne krize, prekinite primjenu lijeka Kyprolis do oporavka ili povratka na početno stanje i razmotrite ponovnu primjenu lijeka Kyprolis s obzirom na procjenu omjera koristi i rizika (vidjeti dio 4.2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 30 mg of carfilzomib.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka bočica sadrži 30 mg karfilzomiba.
English: This is to check that you have enough blood cells and your liver and kidneys are working properly.
Croatian: Prije početka primjene i tijekom liječenja lijekom Kyprolis bit ćete podvrgnuti krvnim pretragama kako bi se provjerilo imate li dovoljno krvnih stanica i rade li Vaša jetra i bubrezi pravilno.
English: • Kidney problems, including kidney failure
Croatian: • Problemi s bubrezima, uključujući zatajenje bubrega
English: Kyprolis 10 mg powder for solution for infusion
Croatian: Kyprolis 10 mg prašak za otopinu za infuziju
English: Kyprolis 30 mg powder for solution for infusion
Croatian: Kyprolis 30 mg prašak za otopinu za infuziju
English: Cataract Blurred vision
Croatian: Katarakta Zamagljen vid
English: Stop Kyprolis for pulmonary hypertension until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Croatian: Prekinite primjenu lijeka Kyprolis u slučaju plućne hipertenzije do oporavka ili povratka na početno stanje i razmotrite ponovnu primjenu lijeka Kyprolis s obzirom na procjenu omjera koristi i rizika (vidjeti dio 4.2).
English: Oropharyngeal pain Dysphonia Wheezing
Croatian: Edem pluća Epistaksa Orofaringealna bol Disfonija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1060/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1060/001
English: Lung infection Influenza Herpes zoster* Urinary tract infection Bronchitis Gastroenteritis Viral infection Nasopharyngitis Rhinitis
Croatian: Herpes zoster* Infekcija mokraćnog sustava
English: The PL is updated accordingly.
Croatian: Informacije o lijeku ažurirane su u skladu s tim.
English: KRd = Kyprolis, lenalidomide and dexamethasone; Rd = lenalidomide and dexamethasone; OS = overall survival; HR = hazard ratio; CI = confidence interval; mo = months a. Study PX-171-009
Croatian: KRd = Kyprolis, lenalidomid i deksametazon; Rd = lenalidomid i deksametazon; OS = sveukupno preživljenje; HR = omjer hazarda; CI = interval pouzdanosti; mj = mjeseci a.
English: GRH0219EN v1
Croatian: GRH0208HR v1
English: Musculoskeletal pain Musculoskeletal chest pain
Croatian: Mišićno-koštana bol Mišićno-koštana bol u prsištu
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1060/003
English: There was an approximately 8%, 23% and 34% increase in the inhibition of LMP7, MECL1, and LMP2 subunits respectively at the dose of 56 mg/m2 compared to those at 15 to 20 mg/m2.
Croatian: Pri dozi od 56 mg/m2, u usporedbi s dozama od 15 do 20 mg/m2, povećanje inhibicije iznosilo je približno 8% za podjedinicu LMP7, 23% za podjedinicu MECL1 i 34% za podjedinicu LMP2.
English: The total volume of fluids may be adjusted as clinically indicated in patients with baseline cardiac failure or who are at risk for cardiac failure (see section 4.2).
Croatian: U bolesnika koji na početku terapije imaju zatajenje srca ili onih s rizikom od zatajenja srca, ukupni volumen tekućina može se podesiti kako je klinički indicirano (vidjeti dio 4.2).
English: The safety and efficacy of Kyprolis were evaluated in a randomised, open-label, multicentre study of 792 patients with relapsed multiple myeloma, which evaluated the combination of Kyprolis with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone, randomised 1:1.
Croatian: Sigurnost i djelotvornost lijeka Kyprolis procijenjene su u randomiziranom, otvorenom, multicentričnom ispitivanju na 792 bolesnika s recidivirajućim multiplim mijelomom.
English: Back pain Arthralgia Pain in extremity Muscle spasms
Croatian: Bol u leđima Artralgija Bol u ektremitetima
English: • Wheezing
Croatian: • Piskanje
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 60 mg powder for solution for infusion carfilzomib
Croatian: Kyprolis 60 mg prašak za otopinu za infuziju karfilzomib
English: Kyprolis, lenalidomide, and dexamethasone
Croatian: Kyprolis, lenalidomid i deksametazon
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion carfilzomib
Croatian: Kyprolis 10 mg prašak za otopinu za infuziju karfilzomib
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 30 mg powder for solution for infusion carfilzomib
Croatian: Kyprolis 30 mg prašak za otopinu za infuziju karfilzomib
English: The total volume of fluids may be adjusted as clinically indicated in patients with baseline cardiac failure or who are at risk for cardiac failure (see section 4.4).
Croatian: U bolesnika koji na početku terapije imaju zatajenje srca ili onih s rizikom od zatajenja srca, ukupni volumen tekućina može se prilagoditi kako je klinički indicirano (vidjeti dio 4.4).
English: Infusion site reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: For clinical management of cardiac disorders during Kyprolis treatment, see section 4.4.
Croatian: Za kliničko liječenje srčanih poremećaja tijekom primjene lijeka Kyprolis, vidjeti dio 4.4.
English: Gastrointestinal haemorrhage Dyspepsia Toothache
Croatian: Tablični prikaz nuspojava
English: Myalgia
Croatian: Zimica
English: Evaluate and stop Kyprolis until resolved and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Croatian: Procijenite bolesnika i prekinite primjenu lijeka Kyprolis do oporavka te razmotritie ponovnu primjenu lijeka Kyprolis s obzirom na procjenu omjera koristi i rizika (vidjeti dio 4.2).
English: • Nausea
Croatian: • Zimica
English: • Dizziness
Croatian: Dispneja
English: For clinical management of thrombocytopenia during Kyprolis treatment, see section 4.4.
Croatian: Za kliničko liječenje trombocitopenije tijekom primjene lijeka Kyprolis, vidjeti dio 4.4.
English: Dyspnoea was commonly reported in patients treated with Kyprolis.
Croatian: U bolesnika liječenih lijekom Kyprolis često su bili prijavljivani slučajevi dispneje.
English: For clinical management of hypertension during Kyprolis treatment, see section 4.4.
Croatian: Za kliničko liječenje hepatotoksičnosti tijekom primjene lijeka Kyprolis, vidjeti dio 4.4.
English: Cases of tumour lysis syndrome (TLS), including with fatal outcome, have been reported in patients who received Kyprolis.
Croatian: U bolesnika u kojih je primjenjivan lijek Kyprolis prijavljeni su slučajevi sindroma lize tumora (TLS, od engl. tumour lysis syndrome), uključujući one sa smrtnim ishodom.
English: Vomiting Diarrhoea Constipation Abdominal pain Nausea
Croatian: Konstipacija Bol u abdomenu Mučnina
English: Haemorrhage
Croatian: Dispneja Kašalj
English: • Anxiety
Croatian: Palpitacije
English: Drug hypersensitivity
Croatian: Hipokalijemija Hiperglikemija
English: Fatigue
Croatian: Piskanje
English: Hepatic failure Cholestasis
Croatian: Zatajenje jetre Kolestaza
English: Quality of the product is considered satisfactory.
Croatian: Kvaliteta proizvoda smatra se zadovoljavajućom.
English: QUALITY - MODULE 3
Croatian: KVALITETA - MODUL 3
English: Generally the infant dose stays below 0.5% of the maternal dose, often even lower.
Croatian: Načelno se doza dojenčadi zadržava ispod 0,5% majčine doze, a češće je i manje.
English: This has now been harmonised.
Croatian: Ovo je usklađeno.
English: Discussions held were mainly around the amount of data currently available for the first trimester.
Croatian: Održane rasprave odnosile su se uglavnom na količinu podataka koja je trenutno dostupna za prvo tromjesečje.
English: The SmPC in other MSs does not include this information.
Croatian: SPC u drugim državama članicama ne sadrži ovu informaciju.
English: It is approved via national, mutual recognition (MRP) or decentralised procedures (DCP).
Croatian: Odobren je putem nacionalnih postupaka međusobnog priznavanja (MRP-ova) ili decentraliziranih postupaka (DCP-ova).
English: No literature review to underpin that conclusion was provided.
Croatian: Nema pregleda literature kojim bi se podržao dostavljeni zaključak.
English: The SmPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Croatian: Tijekom usklađivanja SPC-a razmotrene su sve relevantne terapijske i regulatorne smjernice u EU.
English: The CHMP agreed that no definitive conclusion on the risk during pregnancy can be drawn based on the data available.
Croatian: CHMP je zaključio da se ne može donijeti konačni zaključak o riziku tijekom trudnoće na temelju dostupnih podataka.
English: The CHMP considered all available data which concerned more than 300 cases of exposure during pregnancy.
Croatian: CHMP je razmotrio sve dostupne podatke koji su obuhvatili više od 300 slučajeva izlaganja tijekom trudnoće.
English: Section 4.4 - Special warnings and precautions for use Metabolic risk
Croatian: Dio 4.4 - Posebna upozorenja i mjere opreza pri uporabi Metabolički rizik
English: Based on the review of data the CHMP adopted a harmonised Module 3.
Croatian: Na temelju pregleda ovih podataka, CHMP je usvojio usklađeni Modul 3.
English: In the heading referring to breastfeeding is stated that the degree of excretion in milk is not consistent.
Croatian: U naslovu koji se odnosi na dojenje navodi se da stupanj izlučivanja u mlijeko nije konzistentan.
English: • treatment of schizophrenia
Croatian: • liječenje shizofrenije
English: However, part of the information in this section has been moved from the heading “Somnolence” as explained above.
Croatian: No, dio informacija u ovom dijelu je premješten iz naslova „Somnolencija” kako je prethodno pojašnjeno.
English: Several clinical studies have been published during recent years (e.g. Haberman et al 2013) indicating that there is no major teratogenic risk due to the use of atypical antipsychotics.
Croatian: U posljednjih godina objavljeno je nekoliko kliničkih ispitivanja (primjerice Haberman et al 2013), čime se ukazuje da ne postoji veći teratogeni rizik uslijed primjene atipičnih antipsihotika.
English: Common sources (Briggs et al., 2011; Reprotox Database) reviewed several case reports and some publications reporting on a limited series of pregnancies.
Croatian: Uobičajeni izvori (Briggs et al., 2011; Reprotox baza podataka) pregledali su nekoliko izvještaja slučajeva, a pojedine publikacije prijavile su skromne serije trudnoća.
English: In two MSs the heading read “Somnolence” instead of “Somnolence and dizziness”.
Croatian: U dvije države članice naslov je glasio „Somnolencija” umjesto „Somnolencija i omaglica”.
English: The indication “major depressive episodes” in the MRP SmPC was approved on November 2008 when the indication for bipolar depression was first approved.
Croatian: Indikacija „velike depresivne epizode” u SPC-u MRP-a odobrena je u studenom 2008. godine kada je indikacija za bipolarnu depresiju i prvi put odobrena.
English: Section 4.6 - Fertility, pregnancy and lactation
Croatian: Dio 4.6 - Plodnost, trudnoća i dojenje
English: The limited available data on treatment of mixed episodes was not designed to investigate the efficacy/safety of quetiapine in mixed episodes and showed only a positive non-significant trend in this subgroup.
Croatian: Ograničeni dostupni podaci o liječenju miješanih epizoda nisu namijenjeni istraživanju učinkovitosti/ sigurnosti kvetiapina u slučaju miješanih epizoda i pokazali su da samo pozitivan neznačajan trend u ovoj podgrupi.
English: Hence, these medicinal products were included in the list of products for PI harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC.
Croatian: Stoga, ovi su lijekovi uključeni u popis proizvoda za usklađivanje PI-a kojeg je sastavio CMD(h) u skladu sa člankom 30.(2) Direktive 2001/83/EZ.
English: In several MSs there were discrepancies in section 4.2 due to the differences in the indications.
Croatian: U nekoliko država članica uočene su razlike u dijelu 4.2 uslijed razlika u indikacijama.
English: Severe neutropenia and agranulocytosis
Croatian: Teška neutropenija i agranulocitoza
English: Lastly, an administrative change has been made to the section heading, and the frequency of severe neutropenia has been changed to maintain consistency with the information currently contained in Section 5.1 of the SmPC.
Croatian: Naposljetku, izvršena je administrativna promjena u naslovu dijela, a učestalost teške neutropenije promijenjena je kako bi se održala konzistencija u informacijama koje su trenutno sadržane u Dijelu 5.1 SPC-a.
English: However, and since there were fatal post-marketing reports of agranulocytosis the harmonised wording reflects this information.
Croatian: No, budući da je bilo postmarketinških prijava o smrtnim slučajevima izazvanima agranulocitozom, usklađeni tekst prikazuje ove informacije.
English: Nevertheless, it was considered that the information on the risk of agranulocytosis was unclear.
Croatian: Bez obzira na to, zaključeno je da informacije o riziku od agranulocitoze nisu jasne.
English: Studies in animals as explained in section 5.3 of the SmPC have shown reproductive toxicity.
Croatian: Kako je objašnjeno u dijelu 5.3 SPC-a, ispitivanja provedena na životinjama pokazuju reproduktivnu toksičnost.
English: However, divergent wording has been identified in seven MSs in which “major” was missing in the indication.
Croatian: No, različiti tekstovi utvrđeni su u sedam država članica u kojima je nedostajala riječ „velikih” u indikaciji.
English: Seroquel XR or XL was first approved in the United States in May 2007 and it is available in 50 mg, 150 mg, 200 mg and 400 mg, and as prolonged released tablets in all European Union (EU) Member States (MS), with exception of Bulgaria and Poland.
Croatian: Seroquel XR ili XL je prvi put odobren u Sjedinjenim Američkim Državama u svibnju 2007. godine i dostupan je u tabletama od 50 mg, 150 mg, 200 mg i 400 mg, te u tabletama s produljenim otpuštanjem u svim državama članicama Europske unije (EU), uz iznimku Bugarske i Poljske.
English: The MAH submitted a proposal for harmonisation of the Quality module.
Croatian: Nositelj odobrenja dostavio je prijedlog za usklađivanje modula Kvaliteta.
English: Section 4.1 - Therapeutic Indications
Croatian: Dio 4.1 - Terapijske indikacije
English: Treatment with quetiapine should be reassessed in patients with suspected cardiomyopathy or myocarditis”.
Croatian: Liječenje kvetiapinom treba ponovno ocijeniti u bolesnika za koje se sumnja da imaju kardiomiopatiju ili miokarditis”.
English: A harmonised Module 3 was also adopted.
Croatian: Usvojen je i usklađeni Modul 3.
English: The proposed wording was in line with the current guidance and a clear distinction could be made between the data relevant for the first trimester (potential for congenital abnormalities) and the third trimester (neonatal withdrawal effects).
Croatian: Predloženi tekst bio je u skladu s aktualnom smjernicom i može se uočiti jasna razlika između relevantnih podataka za prvo tromjesečje (potencijali za prirođene abnormalnosti) i treće tromjesečje (neonatalno djelovanje ustezanja).
English: Discontinuing antipsychotic medication in stabilised patients is of particular concern, as well as the development of jaundice.
Croatian: Prekidanje uzimanja antipsihotika u stabiliziranih bolesnika je razlog za posebnu zabrinutost, kao i razvoj žutice.
English: The content was therefore reworded and harmonised across all MSs.
Croatian: Stoga je sadržaj ponovno sastavljen i usklađen na razini svih država članica.
English: Seroquel was first approved in the United Kingdom July 1997 and is available in 25 mg, 100 mg, 150 mg, 200 mg and 300 mg as immediate released tablets.
Croatian: Seroquel je prvi put odobren u Ujedinjenom Kraljevstvu u srpnju 1997. godine i dostupan je u tabletama s neposrednim otpuštanjem od 25 mg, 100 mg, 150 mg, 200 mg i 300 mg.
English: The final text was agreed within this harmonisation procedure and took into account the guidance provided in the guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (EMEA/CHMP/203927/2005), which mentions the available data and lack of teratogenic effects up to now, but also states that no conclusions on risk can be drawn.
Croatian: Konačan tekst je usuglašen u sklopu ovog postupka usklađivanja i uzeo je u obzir preporuku navedenu u smjernici o ocjeni rizika lijekova u ljudskoj reprodukciji i laktaciji: (EMEA/CHMP/203927/2005), koja navodi dostupne podatke i nedostatak teratogenog djelovanja do sada, no također ne koji se zaključci o riziku mogu donijeti.
English: The proposal presented by the MAH reflected the latest scientific information.
Croatian: Prijedlog kojeg je dostavio nositelj odobrenja sadržavao je samo posljednje znanstvene informacije.
English: Although there were no major divergences in the wording, a more concise text concerning cardiovascular to prevent redundancy was agreed aiming specific product information for the prescriber instead of common knowledge on symptoms and consequences of orthostatic hypotension.
Croatian: Iako nema značajnih odstupanja u tekstu, usuglašen je precizniji tekst u vezi s kardiovaskularnim bolestima kako bi se spriječilo ponavljanje, pri čemu su cilj bile specifične informacije o proizvodu za propisivača, umjesto općenitog znanja o simptomima i posljedicama ortostatične preosjetljivosti.
English: The warning stated that “If jaundice develops, quetiapine should be discontinued”.
Croatian: U upozorenju se navodi da „Ako dođe do razvoja žutice treba prekinuti liječenje kvetiapinom”.
English: The CHMP commented on the wording namely on the affinity for serotonin 5HT1A and for norepinephrine transporter (NET) due to the current limited available data in this regard.
Croatian: CHMP je komentirao tekst, i to u dijelu o afinitetu za serotonin 5HT1A i za prijenosnika norepinefrina (NET) uslijed trenutno ograničenih dostupnih podataka u ovom pogledu.
English: The proposed wording was fully endorsed by the CHMP.
Croatian: CHMP je potvrdio predloženi tekst u potpunosti.
English: However, the available data are very limited, and therefore it is recommended that a decision must be made whether to discontinue breast-feeding or to discontinue Seroquel therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the mother.
Croatian: No, dostupni su podaci vrlo ograničeni, te se stoga preporuča da se donese odluka o prekidu dojenja ili prekidu terapije lijekom Seroquel prilikom uzimanja u obzir koristi dojenja za dijete i koristi terapije za majku.