FrancophonIA/ELRC3.0 huggingface dataset:
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Maltese: • Il-kumitat ikkunsidra r-riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE
English: Generally the infant dose stays below 0.5% of the maternal dose, often even lower.
Maltese: Ġeneralment, id-doża tat-tarbija tibqa' taħt 0.5% tad-doża materna, ħafna drabi saħansitra aktar baxxa.
English: Quetiapine is an atypical antipsychotic agent, which together with its active metabolitenorquetiapine - interacts with a broad range of neurotransmitter receptors including serotonin 5hydroxytryptophan type 2 (5HT2A), dopamine type 1 and type 2 (D1, D2), histamine and adrenergic receptors (greatly α1).
Maltese: Quetiapine huwa aġent antipsikotiku atipiku, li flimkien mal-metabolit attiv tiegħu - norquetiapinejinteraġixxi ma' firxa wiesgħa ta' riċetturi newrotrażmettituri inkluż serotonin5-hydroxytryptophan tattip 2 (5HT2A), dopamina tat-tip 1 u t-tip 2 (D1, D2), istamina u riċetturi adrenerġiċi (prinċipalment α1).
English: The limited available data does not indicate a risk for congenital abnormalities.
Maltese: Id-dejta limitata disponibbli ma tindikax riskju għal anormalitajiet konġenitali.
English: A simple extrapolation from schizophrenia trials to other psychosis is not encouraged by the Guideline on clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia (EMA/CHMP/40072/2010 Rev. 1).
Maltese: Estrapolazzjoni sempliċi mill-provi ta' skizofrenja għal psikożi oħra ma tiġix inkoraġġuta mil-Linja gwida dwar l-investigazzjoni klinika ta' prodotti mediċinali, inklużi preparati depot fil-kura ta' skizofrenja (EMA/CHMP/40072/2010
English: Based on the review of data the CHMP adopted a harmonised Module 3.
Maltese: Abbazi tar-reviżjoni tad-dejta, is-CHMP adotta Modulu 3 armonizzat.
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.
Maltese: Seroquel kien l-ewwel approvat fir-Renju Unit f'Lulju 1997 u huwa disponibbli f'25 mg, 100 mg, 150 mg, 200 mg u 300 mg bħala pilloli li jerħu l-mediċini b'mod immedjat.
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction
Maltese: Sezzjoni 4.5 - Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Other warnings of this section i.e. Extrapyramidal symptoms, Tardive Dyskinesia, Seizures, Interactions, Weight, Hyperglycaemia, Elderly patients with dementia-related psychosis and Dysphagia were also harmonised for minor divergences identified among the SmPC approved in the several MSs.
Maltese: Twissijiet oħra ta' din is-sezzjoni jiġifieri Sintomi ekstrapiramidali, Diskajneżja Tardiva, Aċċessjonijiet, Interazzjonijiet, Piż, Ipergliċemija, Pazjenti anzjani bi psikożi relatata mad-demenzja u Disfaġja ġew armonizzati wkoll għal diverġenzi minuri identifikati fost l-SmPC approvati fid-diversi Stati Membri.
English: The final harmonised wording addresses all the identified discrepancies e.g. differences in frequency of reported adverse events like rhinitis.
Maltese: Il-formulazzjoni armonizzata finali tindirizza d-diskrepanzi identifikati kollha eż. differenzi fil-frekwenza tal-avvenimenti avversi rrapportati bħal rinite.
English: Jaundice is a listed, rare adverse event with quetiapine (in section 4.8 of the SmPC).
Maltese: Is-suffejra hija avveniment elenkat rari bi quetiapine (fis-sezzjoni 4.8 tal-SmPC).
English: In four MSs the wording “moderate to severe” was missing in the therapeutic indication.
Maltese: F'erba' Stati Membri, il-formulazzjoni "moderata sa severa" kienet nieqsa fl-indikazzjoni terapewtika.
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.
Maltese: Seroquel XR jew XL ġie approvat l-ewwel fl-Istati Uniti f'Mejju 2007 u huwa disponibbli f'50 mg, 150 mg, 200 mg u 400 mg, u bħala pilloli li jerħu l-mediċina bil-mod fl-Istati Membri (MS) kollha tal-Unjoni Ewropea (UE), bleċċezzjoni tal-Bulgarija u l-Polonja.
English: A harmonised Module 3 was also adopted.
Maltese: Ġie adottat ukoll Modulu 3 armonizzat.
English: The indication “major depressive episodes” in the MRP SmPC was approved on November 2008 when the indication for bipolar depression was first approved.
Maltese: L-indikazzjoni "episodji depressivi qawwijin" fl-SmPC tal-MRP ġiet approvata f'Novembru 2008 meta lindikazzjoni għal depressjoni bipolari kienet approvata għall-ewwel darba.
English: The active metabolite, noraquetapine, shows greater affinity for 5HT2A receptor and is an inhibitor of the norepinephrine transporter.
Maltese: Il-metaboli attiv, noraquetapine, juri affinità akbar għar-riċettur 5HT2A, u huwa inibitur tattrasportatur ta' norepinephrine.
English: • treatment of bipolar disorder o for the treatment of moderate to severe manic episodes in bipolar disorder
Maltese: • kura ta' disturb bipolari o għall-kura ta' episodji moderati sa severi f'disturb bipolari
English: Seroquel XR is indicated as well as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy.
Maltese: Seroquel XR huwa indikat ukoll bħala kura ta' żieda ta' episodji depressivi qawwijin f'pazjenti b'Mard Depressiv Ewlieni (MDD) li kellhom rispons sotto-ottimali għal monoterapija b'antidipressanti.
English: Section 4.4 - Special warnings and precautions for use Metabolic risk
Maltese: Sezzjoni 4.4 - Twissijiet speċjali u prekawzjonijiet għall-użu Riskju metaboliku
English: Seroquel (quetiapine) and Seroquel XR (quetiapine prolonged released formulation) are used for the treatment of schizophrenia and bipolar disorder, being Seroquel XR also used as an add-on treatment in major depression.
Maltese: Seroquel (quetiapine) u Seroquel XR (formulazzjoni li terħi quetiapine bil-mod) jintużaw għall-kura ta' skizofrenjaskizofrenja u disturb bipolari, filwaqt li Seroquel XR jintuża wkoll bħala kura ta' żieda f'depressjoni qawwija.
English: Package Leaflet (PL)
Maltese: Fuljett ta' Tagħrif (PL)
English: Studies in animals as explained in section 5.3 of the SmPC have shown reproductive toxicity.
Maltese: Studji fuq l-annimali spjegati fis-sezzjoni 5.3 tal-SmPC urew tossiċità riproduttiva.
English: Common sources (Briggs et al., 2011; Reprotox Database) reviewed several case reports and some publications reporting on a limited series of pregnancies.
Maltese: Reprotox Database) irrivedew diversi rapporti ta' każijiet u xi pubblikazzjonijiet li rrapportaw dwar serje limitata ta' tqaliet.
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.
Maltese: It-test finali ntlaħaq ftehim dwaru f'din il-proċedura ta' armonizzazzjoni u ħa inkonsiderazzjoni l-gwida pprovduta fil-linja gwida dwar il-valutazzjoni tarriskju tal-prodotti mediċinali dwar ir-riproduzzjoni tal-bniedem u t-treddigħ: mid-dejta għat-tikkettjar (EMEA/CHMP/203927/2005), li ssemmi d-dejta disponibbli u n-nuqqas ta' effetti teratoġeniċi s'issa, iżda li wkoll tiddikjara li ma jistgħu jsiru l-ebda konklużjonijiet dwar ir-riskju.
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.
Maltese: Is-CHMP ikkummenta fuq il-formulazzjoni, jiġifieri fuq l-affinità għal serotonin 5HT1A u t-trasportatur ta' norepinephrine (NET) minħabba d-dejta limitata disponibbli bħalissa f'dan ir-rigward.
English: o for the treatment of major depressive episodes in bipolar disorder
Maltese: o għall-kura ta' episodji depressivi qawwijin f'disturb bipolari
English: Redundant text related to resolution of leucopenia and/or neutropenia following cessation of quetiapine treatment because recovery is implied later in the same paragraph i.e. “Patients should be observed for signs and symptoms of infection and neutrophil counts followed until they exceed 1.5 X 109/l” was removed.
Maltese: It-test żejjed relatat mar-riżoluzzjoni ta' lewkopenja u/jew newtropenija wara l-waqfien tal-kura bi quetiapine peress li aktar tard fl-istess paragrafu huwa implikat irkupru jiġifieri “Il-pazjenti għandhom jiġu osservati għal sinjali u sintomi ta' infezzjoni u l-għadd ta' newtrofili segwiti sakemm dawn jaqbżu 1.5 X 109/l" tneħħa.
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.
Maltese: Ġew ippubblikati diversi studji kliniċi matul l-aħħar snin (eż. Haberman et al 2013) li jindikaw li hemm riskju teratoġeniku kbir minħabba l-użu ta' antipsikotiċi atipiċi.
English: The CHMP addressed a list of questions to the MAH, pointing out the sections of the products SmPC where divergences existed.
Maltese: Is-CHMP indirizza lista ta' mistoqsijiet lill-MAH, fejn indika s-sezzjonijiet tal-SmPC tal-prodotti fejn jeżistu diverġenzi.
English: The harmonised wording for this indication is “Treatment of schizophrenia”.
Maltese: Il-formulazzjoni armonizzata għal din lindikazzjoni hija "Kura ta' skizofrenja".
English: In conclusion, based on the assessment of the MAH proposal and responses and following the discussions of the committee, the CHMP adopted harmonised sets of Product Information documents of Seroquel/Seroquel XR and associated names.
Maltese: Bħala konklużjoni, fuq il-bażi tal-valutazzjoni tal-proposta u r-risponsi tal-MAH u wara ddiskussjonijiet tal-kumitat, is-CHMP adotta settijiet armonizzati ta' dokumenti ta' Informazzjoni dwar il-Prodott ta' Seroquel/Seroquel XR u ismijiet assoċjati.
English: The CHMP supported the MAH decision that the harmonised wording for this indication would be aligned with the MRPapproved SmPC text i.e. separating the indications “Schizophrenia” and “Manic episodes in bipolar disorder”.
Maltese: approvat mill-MRP jiġifieri, is-separazzjoni tal-indikazzjonijiet "Skizofrenja" u "Episodji manijaċi f'disturb bipolari".
English: From all the EU MSs in which Seroquel is approved, only one had a different wording from the MRPapproved SmPC by having the following additional text: “treatment of acute and chronic psychosis, including schizophrenia and manic episodes associated with bipolar disorder”.
Maltese: Mill-Istati Membri kollha tal-UE fejn huwa approvat Seroquel, wieħed biss kellu formulazzjoni differenti mill-SmPC approvata mill-MRP hekk kif kellu t-test addizzjonali li ġej: "kura ta' psikosżi akuta u kronika, inkluż episodji manijaċi u ta' skizofrenija assoċjati ma' disturb bipolari".
English: Severe neutropenia and agranulocytosis
Maltese: Newtropenja u agranuloċitosi severa
English: In several MSs there were discrepancies in section 4.2 due to the differences in the indications.
Maltese: F'diversi Stati Mrembri ma kien hemm ebda diskrepanza fis-sezzjoni 4.2 minħabba d-differenzi flindikazzjonijiet.
English: The CHMP agreed that this warning included redundant information regarding orthostatic hypotension and related dizziness, since it repeated information already included under subheading on Cardiovascular (now Orthostatic hypotension).
Maltese: Is-CHMP qabel li din it-twissija tinkludi informazzjoni żejda dwar ipotensjoni ortostatika u sturdament relatat, peress li rrepetiet informazzjoni li hija diġà inkluża taħt is-sottointestatura dwar Kardjovaskulari (issa Ipotensjoni ortostatika).
English: However, divergent wording has been identified in seven MSs in which “major” was missing in the indication.
Maltese: Madankollu, ġiet identifikata formulazzjoni diverġenti f'seba' Stati Membri fejn "qawwijin" kienet nieqsa fl-indikazzjoni.
English: Seroquel and Seroquel XR are indicated for treatment of schizophrenia and bipolar disorder.
Maltese: Seroquel u Seroquel XR huma indikati għall-kura ta' skizofrenjaskizofrenja u disturb bipolari.
English: After a comparison of current section 4.5 Seroquel and Seroquel XR SmPCs approved nationally versus the most recent MRP-approved Seroquel and Seroquel XR SmPC, only few divergences were noted.
Maltese: Wara paragun tas-sezzjoni 4.5 attwali tal-SmPCs ta' Seroquel u Seroquel XR approvati nazzjonalment meta mqabbel mal-SmPC l-aktar riċenti ta' Seroquel u Seroquel XR approvat mill-MRP, ġew innotati xi ftit diverġenzi biss.
English: Seroquel XR wording was disharmonised by one MS in which the following text: “Treatment of Schizophrenia, including preventing relapse in stable schizophrenic patients who have been maintained on Seroquel XR” was omitted in comparison with the MRP SmPC.
Maltese: Il-formulazzjoni ta' Seroquel XR kellha nuqqas ta' armonizzazzjoni f'wieħed mill-Istati Membri fejn ittest li ġej: “Kura ta' Skizofrenja, inkluża l-prevenzjoni ta' rikaduta f'pazjenti skizofreniċi stabbli li kienu jieħdu Seroquel XR" kienet tħalliet barra meta mqabbel mal-SmPC tal-MRP.
English: The pivotal clinical studies for this indication were conducted in a patient population having moderate to severe manic episodes in bipolar disorder.
Maltese: L-istudji kliniċi pivotali għal din l-indikazzjoni twettqu f'popolazzjoni ta' pazjenti li għandhom episodji manijaċi moderati sa severi f'disturb bipolari.
English: All MSs have the same or similar wording in their Seroquel and Seroquel XR SmPCs with regards absorption, distribution, elimination, gender, elderly and renal impairment.
Maltese: L-Istati Membri kollha għandhom l-istess formulazzjoni jew simili fl-SmPCs ta' Seroquel u Seroquel XR tagħhom fir-rigward tal-assorbiment, id-distribuzzjoni, l-eliminazzjoni, is-sess, l-anzjani u lindeboliment tal-kliewi.
English: The warning on cardiomyopathy and myocarditis was included through a type II variation, which was finalised during the assessment of this referral procedure under Article 30 from Directive 2001/83/EC started.
Maltese: It-twissija fuq il-kardjomijopatija u mijokardite ġiet inkluża permezz ta' varjazzjoni tat-tip II, li kienet finalizzata matul il-valutazzjoni ta' din il-proċedura ta' riferiment taħt l-Artikolu 30 midDirettiva 2001/83/KE nbdiet.
English: The final agreed wording is part of the harmonised SmPCs for Seroquel and for Seroquel XR.
Maltese: Ilformulazzjoni miftiehma finali hija parti mill-SmPCs armonizzati għal Seroquel u għal Seroquel XR. Jekk jogħġbok ara Anness III.
English: This has now been harmonised.
Maltese: Bħala riżultat ta' din ilproċedura ta' armonizzazzjoni.
English: The wording on “Constipation and intestinal obstruction” was already harmonised.
Maltese: Il-formulazzjoni dwar l-"Istitikezza u ostruzzjoni intestinali" kienet diġà armonizzata.
English: The wording under review was provided within the MAH responses to the CHMP list of questions of this Article 30 harmonisation procedure.
Maltese: Il-formulazzjoni taħt reviżjoni ġiet ipprovduta fir-risponsi tal-MAH għal-lista tas-CHMP tal-mistoqsijiet ta' din il-proċedura ta' armonizzazzjoni tal-Artikolu 30.
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.
Maltese: Fl-aħħar nett, saret bidla amministrattiva fl-intestatura tas-sezzjoni, u l-frekwenza ta' newtropenija severa nbidlet biex tinżamm konsistenza mal-informazzjoni li tinsab attwalment fis-Sezzjoni 5.1 talSmPC.
English: This section was updated in format of the adverse reactions listed according to the QRD template.
Maltese: Din is-sezzjoni ġiet aġġornata fil-format tar-reazzjonijiet avversi elenkati skont il-mudell tal-QRD.
English: The wording under review in the variation procedure was provided within the MAH responses to the CHMP list of questions of this Article 30 harmonisation procedure.
Maltese: Il-formulazzjoni taħt reviżjoni fil-proċedura ta' varjazzjoni ġiet ipprovduta fir-risponsi tal-MAH għal-lista tas-CHMP tal-mistoqsijiet ta' din il-proċedura ta' armonizzazzjoni tal-Artikolu 30.
English: Furthermore, the recommendations for up-titration and for daily dose in some indications i.e. schizophrenia, moderate to severe episodes in bipolar disorder and major depressive episodes in bipolar disorder differed among MSs.
Maltese: Barra minn hekk, ir-rakkomandazzjonijiet għal titrazzjoni ‘l fuq u għad-doża ta' kuljum f'xi indikazzjonijiet jiġifieri skizofrenja, episodji moderati sa severi f'disturb bipolari u episodji depressivi qawwijin f'disturb bipolari kien ivarja fost l-Istati Membri.
English: Overall summary of the scientific evaluation of Seroquel/Seroquel XR and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Seroquel/Seroquel XR u ismijiet assoċjati (ara Anness I)
English: The proposed wording was fully endorsed by the CHMP.
Maltese: Ilformulazzjoni proposta kienet appoġġjata b'mod sħiħ mis-CHMP.
English: • The committee reviewed the data submitted by the MAH on the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the product information
Maltese: • Il-kumitat analizza d-dejta sottomessa mill-MAH dwar l-istudji kliniċi eżistenti, id-dejta dwar il-farmakoviġilanza u t-tagħrif ippubblikat li jiġġustifikaw l-armonizzazzjoni proposta tal-informazzjoni dwar il-prodott
English: The SmPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Maltese: L-armonizzazzjoni tal-SmPC qieset il-linji gwida terapewtiċi u regolatorji rilevanti kollha fl-UE.
English: Therefore this warning was reworded to clearly state that patients need to immediately report the appearance of symptoms consistent with agranulocitosys or infection, during Seroquel therapy and physicians to proceed to white blood cells (WBC) count and absolute neutrophil count (ANC) in the absence of predisposition factors.
Maltese: Għaldaqstant, din it-twissija ġiet ifformuluta mill-ġdid biex tiddikjara li l-pazjenti jeħtieġu li jirrapportaw id-dehra ta' sintomi konsistenti ma' agranuloċitożi jew infezzjoni, waqt it-terapija b'Seroquel u tobba biex jipproċedu għall-għadd taċ-ċelluli bojod tad-demm (WBC) u l-għadd assolut ta' newtrofili (ANC) fin-nuqqas ta' fatturi ta' predispożizzjoni.
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).
Maltese: Il-formulazzjoni proposta kienet f'konformità mal-gwida attwali u tista' ssir distinzjoni ċara bejn iddejta rilevanti għall-ewwel trimestru (potenzjal għal anormalitajiet konġenitali) u t-tielet trimestru (effetti ta' ritirar tat-twelid).
English: Divergent information was identified in one MS namely with regards to hepatic impairment and paediatric population.
Maltese: Ġiet identifikata informazzjoni diverġenti fi Stat Membru wieħed, jiġifieri firrigward tal-indeboliment tal-fwied u l-popolazzjoni pedjatrika.
English: The exact mechanism of action of quetiapine, similarly with other antipsychotics, is still unknown, but the combination of receptor antagonism with a higher selectivity for 5HT2 relative to D2 receptors may contribute to its psychotropic activity and mood stabilizing properties.
Maltese: Il-mekkaniżmu ta' azzjoni eżatt ta' quetiapine, b'mod simili għal antipsikotiċi oħra, għadu mhux magħruf, iżda l-kombinazzjoni ta' antagoniżmu tar-riċettur b'selettività għolja għal riċetturi 5HT2 relattivi għal D2 tista' tikkontribwixxi għall-attività psikotropika u l-proprjetajiet li jistabbilizzaw ilburdata.
English: Please see SmPC for Seroquel and Seroquel XR in Annex III.
Maltese: III għal Seroquel u Seroquel XR u ismijiet assoċjati (ara Anness I).
English: Three MSs had the following wording: “For the prevention of recurrence in patients with bipolar disorder, in patients whose manic, mixed or depressive episode has responded to quetiapine treatment”, while twenty other MSs had the current MRP-approved SmPC, without the word “mixed”.
Maltese: "Għall-prevenzjoni ta' rikorrenza fil-pazjenti b'disturb bipolari, f'pazjenti li l-episodju manijaku, imħallat jew depressiv tagħhom irrisponda għallkura bi quetiapine", filwaqt li għoxrin Stat Membru ieħor kellhom l-SmPC attwali approvat mill-MRP, mingħajr il-kelma "imħallat".
English: The harmonised wording for the SmPC and found in the majority of the EU MSs i.e. “moderate to severe” is considered appropriate and provides useful information for the prescribing physician as to the patient population that will benefit from taking Seroquel.
Maltese: Il-formulazzjoni armonizzata għall-SmPC u li tinsab filbiċċa l-kbira tal-Istati Membri tal-UE jiġifieri "moderata sa severa" mhijiex ikkunsidrata adegwata u tipprovdi informazzjoni utli għat-tabib li jikteb ir-riċetti fir-rigward tal-popolazzjoni ta' pazjenti li sejrin jibbenefikaw mit-teħid ta' Seroquel.
English: o for the prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment.
Maltese: o għall-prevenzjoni tar-rikorrenza ta' episodji manijaċi jew depressivi f'pazjenti b'disturb bipolari li preċedentement irrispondew għal kura b'qeutiapine.
English: The warning stated that “If jaundice develops, quetiapine should be discontinued”.
Maltese: It-twissija ddikjarat li "Jekk tiżviluppa suffejra, quetiapine għandu jitwaqqaf".
English: The manufacture and control of both the active substance and the finished product comply with CHMP/ICH guidelines.
Maltese: Il-manifattura u l-kontroll kemm tas-sustanza attiva kif ukoll tal-prodott finali jikkonformaw mal-linji gwida CHMP/ICH.
English: The MAH proposed the harmonised text as per MRP SmPC which reflects the current knowledge and data on Seroquel and Seroquel XR.
Maltese: L-MAH ippropona t-test armonizzat skont l-SmPC tal-MRP li jirrifletti l-għarfien attwali u d-dejta dwar Seroquel u Seroquel XR.
English: The wording approved by the variation as follows: “Cardiomyopathy and myocarditis have been reported in clinical trials and during the post-marketing experience, however, a causal relationship to quetiapine has not been established.
Maltese: Il-formulazzjoni approvata mill-varjazzjoni hija kif ġejja: “Ġew irrapportati kardjomijopatija u mijokardite fi provi kliniċi u matul l-esperjenza ta' wara t-tqegħid fissuq, madankollu, ma ġietx stabbilita relazzjoni każwali ma' quetiapine.
English: It was agreed that the harmonised wording related to section 4.5 is the already approved Seroquel and Seroquel XR MRP SmPC.
Maltese: Intlaħaq qbil li l-formulazzjoni armonizzata relatata mas-sezzjoni 4.5 hija l-SmPC tal-MRP diġà approvata ta' Seroquel u Seroquel XR. Jekk jogħġbok ara l-SmPC għal Seroquel u Seroquel XR fl-Anness
English: Mainly these regard missing information on children and adolescents who received valproate, quetiapine or both, and found a higher incidence of leucopenia and neutropenia in the combination group versus the monotherapy groups.
Maltese: Ġeneralment, dawn iqisu l-informazzjoni dwar it-tfal u l-adolexxenti li rċevew valproate, quetiapine jew it-tnejn, u sabu inċidenza ogħla ta' lewkopenja u newtropenja fil-grupp ta' kombinazzjoni meta mqabbel mal-gruppi ta' monoterapija.
English: The information in this section was mainly consistent in the SmPC of Seroquel and Seroquel XR across all MSs.
Maltese: L-informazzjoni f'din is-sezzjoni kienet prinċipalment konsistenti fl-SmPC ta' Seroquel u Seroquel XR madwar l-Istati Membri kollha.
English: In the heading referring to breastfeeding is stated that the degree of excretion in milk is not consistent.
Maltese: Fl-intestatura li tirreferi għat-treddigħ, huwa ddikjarat li l-grad ta' eliminazzjoni fil-ħalib mhuwiex konsistenti.