FrancophonIA/ELRC3.0 huggingface dataset:
English: Risk mitigation measures
Maltese: Valutazzjoni tar-riskji
English: The CVMP does not accept these arguments, where the marketing authorisation holder's products have the same proportional risk for selecting antimicrobial resistant bacteria as zinc oxide mono-products.
Maltese: Is-CVMP ma jaċċettax dawn l-argumenti, fejn il-prodotti tad-detentur talawtorizzazzjoni għat-tqegħid fis-suq għandhom l-istess riskju proporzjonali għall-għażla ta' batterji reżistenti għall-antimikrobiċi bħal monoprodotti tal-ossidu taż-żingu.
English: 13 Metal bioavailability assessment tool (M-BAT) - link 14 Arche Consulting Soil PNEC calculator - link making a correction on the exposure assessment for bioavailability of metals in sediment systems (ECHA 2014)15.
Maltese: Iż-żingu jeħel sew mal-AVS u ma jibqax bijodisponibbli, u dan jippermetti korrezzjoni tal-valutazzjoni tal-esponiment għall-bijodisponibbiltà tal-metalli fis-sistemi tas-sedimenti (ECHA 2014)
English: In conclusion the combination of zinc oxide and sulfaguanidine is not justified.
Maltese: B'konklużjoni, it-taħlita tal-ossidu taż-żingu u sulfaguanidine mhijiex ġustifikata.
English: Overall, of the bibliographic references provided by the marketing authorisation holders there were issues with the study designs that preclude support of 2500 ppm zinc oxide in feed for 14 days post-weaning as described in the approved indications.
Maltese: B'mod ġenerali, mir-referenzi biblijografiċi pprovduti mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq kien hemm kwistjonijiet fit-tfassil tal-istudju li prekludew appoġġ ta' 2500 ppm ossidu taż-żingu fl-għalf għal 14-il jum wara l-ftim kif deskritt fil-indikazzjonijiet approvati.
English: For this referral procedure, and to support the risk assessment on zinc from its oral use as a veterinary medicinal product in food producing animals, Bak et al. (2015)22 analysed for a 28 year period following application of pig slurry.
Maltese: (2015)22 analizza perjodu ta' 28 sena wara applikazzjoni ta' demel likwidu tal-ħnieżer.
English: Benefit-risk assessment
Maltese: 3. Valutazzjoni benefiċċji/riskji
English: For this 30% contribution alone a risk is already identified for Danish soils.
Maltese: Għal dan il-kontribut ta' 30 % biss diġà hemm riskju identifikat għal ħamrija Daniża.
English: Consequently, the CVMP considers that in the light of overall data available, environmental risks identified by the continuous annual accumulation of zinc in soil from the spreading of manure in agricultural land cannot be effectively controlled through the application of the two risk mitigation measures presented above.
Maltese: Konsegwentement, is-CVMP jikkunsidra li fid-dawl tad-data globali disponibbli, ir-riskji ambjentali identifikati mill-akkumulazzjoni annwali kontinwa taż-żingu fil-ħamrija mit-tixrid ta' demel f'art agrikola ma jistgħux jiġu kkontrollati b'mod effettiv permezz tal-applikazzjoni taż-żewġ miżuri ta' mitigazzjoni tar-riskji ppreżentati hawn fuq.
English: The marketing authorisation holder Huvepharma presented a pragmatic approach on their exposure assessment on Gutal and considered the results from a model used by EFSA (the Intermediate Dynamic Model for Metal (IDMM) by Monteiro et al. (2010))19 for estimating the environmental exposure from the use of zinc oxide as feed additive.
Maltese: Dinamiku Intermedju għall-Metall (IDMM, Intermediate Dynamic Model for Metal) minn Monteiro et al.
English: Treatments consisted in a baseline diet of 100 ppm zinc in the form of zinc oxide or the same diet supplemented with 2400 ppm zinc (as zinc oxide).
Maltese: Il-kuri kienu jikkonsistu f'dieta tal-linja bażi ta' 100 ppm żingu fil-forma ta' ossidu taż-żingu jew l-istess dieta ssupplimentata b'2400 ppm żingu (bħala ossidu taż-żingu).
English: The CVMP recognises the importance of bioavailability when addressing toxicity of metals, and considers that while different models might take into consideration the bioavailable fraction of zinc oxide and conclude on a slight different timeframe for when (i.e., in which year) environmental risks are predicted to occur, none of the models support a prediction of no environmental risk from the use of zinc oxide as a veterinary medicinal product, nor that zinc in soil will not become bioavailable to soil, water or aquatic biota.
Maltese: Is-CVMP jirrikonoxxi l-importanza tal-bijodisponibbiltà meta jindirizza ttossiċità tal-metalli, u jikkunsidra li waqt li mudelli differenti jistgħu jikkunsidraw il-frazzjoni bijodisponibbli tal-ossidu taż-żingu u jikkonkludu dwar żmien propost xi ftit differenti għal meta (jiġifieri, f'liema sena) r-riskji ambjentali huma previsti li jseħħu, l-ebda wieħed mill-mudelli ma jappoġġja previżjoni tal-ebda riskju ambjentali mill-użu tal-ossidu taż-żingu bħala prodott mediċinali veterinarju, u lanqas li ż-żingu fil-ħamrija mhux se jsir bijodisponibbli fil-bijota tal-ħamrija, tal-ilma jew akkwatika.
English: The Metal Bioavailability Assessment Tool is based on the outputs from the zinc Biotic Ligand Models and the dataset used in the derivation of the Environmental Quality Standard for zinc, and only requires input data for water pH, dissolved organic carbon and dissolved calcium concentration, but does not take into account the presence of other ions that could affect zinc speciation and, hence, bioavailability.
Maltese: L-Għodda ta' Valutazzjoni tal-Bijodisponibbiltà tal-Metall hija bbażata fuq ir-riżultati mill-Mudell Biotic Ligand u s-sett ta' data użat fid-derivazzjoni tal-Istandard tal-Kwalità Ambjentali għaż-żingu, u teħtieġ biss data ta' input għall-pH tal-ilma, il-karbonju organiku dissolt u l-konċentrazzjoni ta' kalċju dissolt, iżda ma tqisx il-preżenza ta' jonji oħra li jistgħu jaffettaw l-ispeċjazzjoni taż-żingu u, għalhekk, il-bijodisponibbiltà.
English: However, and as noted above, the previously suggested risk mitigation measures would slow down the accumulation of zinc in each compartment, thus just delaying the total zinc accumulation in the environment (i.e. the time when PEC will exceed PNECs), but given the nature of zinc they cannot guarantee that they can effectively eliminate imminent and future environmental risks identified in the risk assessment.
Maltese: Madankollu, u kif innutat hawn fuq, il-miżuri ta' mitigazzjoni tar-riskji ssuġġeriti preċedentement imajnaw l-akkumulazzjoni tażżingu f'kull kompartiment, u għalhekk sempliċiment idewmu l-akkumulazzjoni totali taż-żingu flambjent (jiġifieri l-ħin meta l-PEC se taqbeż l-PNECs), iżda minħabba n-natura taż-żingu ma jistgħux jiggarantixxu li jistgħu jeliminaw b'mod effettiv riskji ambjentali imminenti u futuri identifikati filvalutazzjoni tar-riskji.
English: Several published studies demonstrated (during in vivo experiments or by investigating environmental isolates) a correlation between high doses of zinc supplementation in food and the prevalence of antimicrobial resistance.
Maltese: Diversi studji ppubblikati wrew (waqt esperimenti in vivo jew permezz ta' investigazzjoni ta' iżolati ambjentali) korrelazzjoni bejn dożi għoljin ta' supplimentazzjoni taż-żingu fl-ikel u l-prevalenza ta' reżistenza antimikrobika.
English: Consequently, the CVMP considered that the PNECs proposed by the marketing authorisation holder Huvepharma can be used for the characterisation of risks (calculation of risk quotients (RQs)) of veterinary products containing zinc oxide to be used orally in food producing animals.
Maltese: Konsegwentament, is-CVMP ikkunsidra li l-PNECs proposti mid-detentur tal-awtorizzazzjoni għattqegħid fis-suq Huvepharma jistgħu jintużaw għall-karaterizzazzjoni tar-riskji (kalkolu tal-kwozjenti ta' riskju (RQs, risk quotients)) ta' prodotti veterinarji li fihom l-ossidu taż-żingu li għandhom jintużaw b'mod orali f'annimali li jipproduċu l-ikel.
English: Regarding the risk mitigation measure for compliance with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to prevent direct entry to water courses, but would not affect the zinc reaching surface water and drinking water by leaching and run-off processes.
Maltese: Rigward il-potenzjal għal tnaqqis ta' riskju meta jkun hemm konformità mar-regoli lokali jew nazzjonali għad-distanza minima minn ilma mikxuf li fih għandu jinxtered id-demel, is-CVMP ikkunsidra li dan ikun applikabbli biss biex jipprevjeni dħul dirett f'kanali tal-ilma, iżda ma jaffettwax iżżingu li jilħaq l-ilma tal-wiċċ permezz ta' proċessi ta' lissija u ta' skol.
English: A reduction in the use of antimicrobials to treat post-weaning diarrhoea in piglets is likely to reduce the selective pressure for antimicrobial resistance development.
Maltese: Tnaqqis fl-użu ta' antimikrobiċi fil-kura ta' dijarea wara l-ftim fil-qżieqeż aktarx tnaqqas il-pressjoni selettiva għal żvilupp ta' reżistenza antimikrobika.
English: 2745-663 Barcarena Portugal
Maltese: 2745-663 Barcarena
English: {Name and Address} <{tel}> <{fax}>
Maltese: {Isem u indirizz} <{telefon}> <{fax}> <{e-mail}>
English: Rua Humberto Madeira, 7 Valejas
Maltese: Rua Humberto Madeira, 7
English: Irritability4
Maltese: Irritabilità4
English: (21) See Section 5.1
Maltese: (21) Ara Sezzjoni 5.1
English: Hyperprolactinemia16
Maltese: Iperprolaktinemija16
English: IE - Ireland AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU
Maltese: IE - L-Irlanda AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU
English: Angioedema6, Stevens-Johnson syndrome6
Maltese: Anġjoedema 6, Sindrome Stevens-Johnson
English: Tablet coating: hypromellose, macrogol, titanium dioxide (E171).
Maltese: Kisi tal-pillola: hypromellose, macrogol, titanium dioxide (E171).
English: ES- Spain
Maltese: ES- Spanja
English: • Abnormal muscle movements.
Maltese: • Movimenti abnormali tal-muskoli.
English: 0319 Oslo, Norway
Maltese: (PO Box 200), 0319 Oslo, Norway
English: Mild asthenia, peripheral oedema, irritability
Maltese: Astenija ħafifa, edema periferali, irritabilità
English: SE - Sweden AstraZeneca AB AstraZeneca Sverige SE-151 85 Södertälje Sweden
Maltese: SE - L-Isvezja AstraZeneca AB AstraZeneca Sverige SE-151 85 Södertälje
English: AstraZeneca Produtos Farmacêuticos, Lda.
Maltese: PT - Il-Portugall AstraZeneca Produtos Farmacêuticos, Lda.
English: FI - Finland AstraZeneca Oy Luomanportti 3
Maltese: FI - Il-Finlandja AstraZeneca Oy Luomanportti 3
English: DE - Germany AstraZeneca GmbH, Tinsdaler Weg 183, 22880 Wedel,
Maltese: AstraZeneca GmbH, Tinsdaler Weg 183, 22880
English: Priapism, Galactorrhoea
Maltese: Prijapiżmu, Galaktorreja
English: IS - Iceland AstraZeneca A/S Roskildevej 22
Maltese: IS - L-Islanda AstraZeneca A/S Roskildevej 22
English: Tablet core: microcrystalline cellulose, sodium citrate, lactose monohydrate, magnesium stearate, hypromellose.
Maltese: Qalba tal-pillola: microcrystalline cellulos, sodium citrate, lactose monohydrate, magnesium stearate, hypromellose.
English: Epilepsy medicines (like phenytoin or carbamazepine).
Maltese: - Mediċini għall-epilessija (bħal phenytoin u carbamazepine).
English: Dysphagia8
Maltese: Disfaġja8
English: BE - Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussel
Maltese: BE - Il-Belġju NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussel
English: Iron oxide, yellow (E172) (50, 200 and 300 mg tablets) Iron oxide, red (E172) (50 mg tablets) 6.2 Incompatibilities
Maltese: Iron oxide, yellow (E172) (pilloli ta' 50, 200 u 300 mg) Iron oxide, red (E172) (pilloli ta' 50 mg) 6.2 Inkompatibilitajiet
English: • treatment of major depressive episodes in bipolar disorder.
Maltese: • trattament ta' episodji depressivi maġġuri fid-disturb bipolari.
English: Venous Thromboembolism (VTE):
Maltese: Tromboemboliżmu fil-Vini (VTE):
English: Children and adolescents (10 to 17 years of age)
Maltese: Tfal u adolexxenti (10 sa 17-il sena)
English: Seizure 1, Restless legs syndrome, Tardive dyskinesia 1, 6
Maltese: Aċċessjoni 1, Sindrome tas-saqajn irrikwieti, Diskajniżja Tardiva 1, 6
English: Metabolic Risk
Maltese: Riskju metaboliku:
English: C/ Serrano Galvache, 56Edificio Roble 28033 Madrid Spain
Maltese: AstraZeneca Farmacéutica Spain, S.A. C/ Serrano Galvache, 56 - Edificio Roble 28033 Madrid
English: Distribution: Quetiapine is approximately 83% bound to plasma proteins.
Maltese: Quetiapine jintrabat madwar 83% mal-proteini tal-plażma.
English: Interactions: See also section 4.5.
Maltese: Ara wkoll sezzjoni 4.5.
English: PL - Poland AstraZeneca UK Limited, 15 Stanhope Gate,
Maltese: PL - Il-Polonja AstraZeneca UK Limited, 15
English: Bipolar Disorder
Maltese: Disturb Bipolari
English: <{e-mail}>
Maltese: {XX/SSSS}
English: Carton (pack) contents Blisters
Maltese: Kontenuti tal-kartuna (pakkett)
English: AT - Austria AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien
Maltese: AT - L-Awstrija AstraZeneca Österreich GmbH Schwarzenbergplatz 7
English: Dizziness4, 17, somnolence 2, 17, headache
Maltese: Sturdament4, 17, ngħas 2, 17, uġigħ ta' ras
English: NO- Norway AstraZeneca AS, Hoffsveien 70B, (PO Box 200),
Maltese: AstraZeneca AS, Hoffsveien 70B,
English: Quetiapine and several of its metabolites (including norquetiapine) were found to be weak inhibitors of human cytochrome P450 1A2, 2C9, 2C19, 2D6 and 3A4 activities in vitro.
Maltese: Quetiapine u ħafna mill-metaboli tiegħu (inkluż norquetiapine) instab li huma inibituri dgħajfa ta' lattivitajiet ta' cytochrome uman P450 1A2, 2C9, 2C19, 2D6 u 3A4 in vitro.
English: Responder rates (YMRS improvement ≥50%) were 64% for Seroquel 400 mg/day, 58% for 600 mg/day and 37% in the placebo arm.
Maltese: Rati ta' rispondituri (Titjib YMRS ≥50%) kienu 64% għal Seroquel 400 mg/jum, 58% għal 600 mg/jum u 37% fil-fergħa tal-plaċebo.
English: Pack sizes of 10, 30, 50, 60 and 100 tablets are registered for all strengths.
Maltese: Daqsijiet tal-pakkett ta' 10, 30, 50, 60 u 100 pillola huma reġistrati għall-qawwiet kollha.
English: Orthostatic hypotension 4, 17 Venous thromboembolism1 Respiratory, thoracic and mediastinal disorder Common:
Maltese: Pressjoni titbaxxa mal-pożizzjoni 4, 17 Tromboemboliżmu fil-vini1 Disturbi respiratorji, toraċiċi u medjastinali Komuni:
English: CY - Cyprus AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA,
Maltese: AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, United Kingdom
English: An increase in LDL cholesterol of ≥30 mg/dL ( 0.769 mmol/L) has been very commonly observed.
Maltese: Żieda fil-kolesterol LDL ta' ≥30 mg/dL ( 0.769 mmol/L) kien osservat b'mod komuni ħafna.
English: • The active substance is quetiapine.
Maltese: • Is-sustanza attttva hija quetiapine.
English: Major depressive episodes in MDD
Maltese: Episodji depressivi kbar f'MDD
English: Eosinophilia, Thrombocytopenia
Maltese: Eżinofilja, Tromboċitopenija
English: ¾Swedish Record Linkage Study (SE-RLS) in accordance with an agreed protocol.
Maltese: ¾ Studju dwar is-Swedish Record Linkage (SE-RLS) f'konformità ma' protokoll miftiehem.
English: Reproductive system and breast disorders Rare:
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Rari:
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.
Maltese: Livelli tal-prolaktin (pazjenti < 18-il sena): >20 μg/L (>869.56 pmol/L) irġiel; >26 μg/L (>1130.428 pmol/L) nisa fi kwalunkwe ħin.
English: Dysphagia (See section 4.8 Undesirable effects) has been reported with quetiapine.
Maltese: Disfaġja (Ara sezzjoni 4.8 Effetti mhux mixtieqa) kienet irrappurtata b'quetiapine.
English: The AUC and Cmax for the active metabolite, norquetiapine, were higher, approximately 62% and 49% in children (10-12 years), respectively and 28% and 14% in adolescents (13-17 years), respectively, compared to adults.
Maltese: L-AUC u s-Cmax tal-metabolu attiv, norquetiapine, kienu ogħla, madwar 62% u 49% fi tfal (10-12-il sena), rispettivament u 28% u 14% fl-adolexxenti (13-17-il sena), rispettivament meta mqabbla ma' l-adulti.
English: Seroquel XR 50 mg contains 50 mg quetiapine (as quetiapine fumarate) Excipient : 119 mg lactose (anhydrous) per tablet Seroquel XR 150 mg contains 150 mg quetiapine (as quetiapine fumarate) Excipient : 71 mg lactose (anhydrous) per tablet Seroquel XR 200 mg contains 200 mg quetiapine (as quetiapine fumarate) Excipient : 50 mg lactose (anhydrous) per tablet Seroquel XR 300 mg contains 300 mg quetiapine (as quetiapine fumarate) Excipient : 47 mg lactose (anhydrous) per tablet Seroquel XR 400 mg contains 400 mg quetiapine (as quetiapine fumarate) Excipient : 15 mg lactose (anhydrous) per tablet
Maltese: Seroquel XR 50 mg fih 50 mg quetiapine (bħala quetiapine fumarate) Sustanza mhux attiva: 119 mg lactose (anidrat) għal kull pillola Seroquel XR 150 mg fih 150 mg quetiapine (bħala quetiapine fumarate) Sustanza mhux attiva: 71 mg lactose (anidrat) għal kull pillola Seroquel XR 200 mg fih 200 mg quetiapine (bħala quetiapine fumarate) Sustanza mhux attiva: 50 mg lactose (anidrat) għal kull pillola Seroquel XR 300 mg fih 300 mg quetiapine (bħala quetiapine fumarate) Sustanza mhux attiva: 47 mg lactose (anidrat) għal kull pillola Seroquel XR 50 mg fih 400 mg quetiapine (bħala quetiapine fumarate) Sustanza mhux attiva: 15 mg lactose (anidrat) għal kull pillola
English: Formal interaction studies with commonly used cardiovascular medicinal products have not been performed.
Maltese: Studji formali dwar l-interazzjoni ma' prodotti mediċinali kardjovaskulari ma sarux.
English: Additionally, norequetiapine has high affinity for the norepinephrine transporter (NET).
Maltese: Minbarra hekk, norequetiapine għandu affinità għolja għat-trasportatur ta' norepinephrine (NET).
English: Note: The frequency is consistent to that observed in adults, but irritability might be associated with different clinical implications in children and adolescents as compared to adults.
Maltese: Nota: Il-frekwenza hija konsistenti ma' dik li dehret fl-adulti, iżda l-irritabilità tista' tkun assoċjata ma' implikazzjonijiet differenti bejn it-tfal u adolexxenti meta mqabbla ma' l-adulti.
English: (18) HDL cholesterol: <40 mg/dL (1.025 mmol/L) males; <50 mg/dL (1.282 mmol/L) females at any time.
Maltese: (17) Jista' jikkawża waqat (18) Kolesterol HDL: <40 mg/dL (1.025 mmol/L) irġiel; <50 mg/dL (1.282 mmol/L) nisa f'kull ħin.
English: Seroquel XR 400 mg/day, 600 mg/day and 800 mg/day were associated with statistically significant improvements in psychotic symptoms compared to placebo.
Maltese: Seroquel XR 400 mg/jum, 600 mg/jum u 800 mg/jum kienu assoċjati ma' titjib statistikament sinifikanti fis-sintomi psikotiċi mqabbla mal-plaċebo.
English: Quetiapine and norquetiapine exhibit affinity for brain serotonin (5HT2) and dopamine D1- and D2- receptors.
Maltese: Quetiapine u norquetiapine juru affinità għal serotonin fil-moħħ (5HT2) u riċetturi-D1 u -D2 ta' dopamine.
English: • treatment of moderate to severe manic episodes in bipolar disorder.
Maltese: • trattament ta' episodji moderati sa severi ta' manija fid-disturb bipolari.
English: The available evidence from placebo-controlled clinical trials with Seroquel is presented in sections 4.4, 4.8, 5.1 and 5.2..
Maltese: L-evidenza li hemm minn provi ikkontrollati bi plaċebo b'Seroquel qed tingħata f'sezzjonijiet 4.4, 4.8, 5.1 u 5
English: The number of patients with a mood event was 91 (22.5%) in the quetiapine group, 208 (51.5%) in the placebo group and 95 (26.1%) in the lithium treatment groups respectively.
Maltese: In-numru ta' pazjenti li kellhom każ relatat mal-burdata kien 91 (22.5%) fil-grupp fuq quetiapine, 208 (51.5%) fil-grupp fuq plaċebo u 95 (26.1%) fil-grupp ta' kura b'lithium rispettivament.
English: The efficacy and safety of Seroquel was studied in a 3-week placebo controlled study for the treatment of mania (n= 284 patients from the US, aged 10-17).
Maltese: L-effikaċja u s-sigurtà ta' Seroquel kienet studjata fi studju ta' 3 ġimgħat kontrollat bi plaċebo għallkura ta' manija (n=284 pazjent mill-US, età 10-17).
English: The overall safety profile in the elderly patients was similar to that in younger adult patients; however a higher frequency of somnolence, dizziness and extrapyramidal symptoms (EPS) was observed.
Maltese: Il-profil ta' sigurtà globali fil-pazjenti aktar anzjani kien simili għal dak f'pazjenti adulti iżgħar; madankollu ġiet osservata frekwenza ogħla ta' sonnolenza, sturdament u sintomi ekstrapiramidali (EPS).
English: Contains lactose monohydrate.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Fih lactose monohydrate.
English: Cytochrome P450 (CYP) 3A4 is the enzyme that is primarily responsible for the cytochrome P450 mediated metabolism of quetiapine.
Maltese: Cytochrome P450 (CYP) 3A4 hija enzima li hija responsabbli l-aktar għall-metaboliżmu ta' quetiapine permezz ta' cytochrome P450.
English: EL - Greece AstraZeneca S.A. 4 Theotokopoulou & Astronafton 151 25
Maltese: Theotokopoulou & Astronafton 151 25
English: Severe neutropenia (neutrophil count <0.5 X 109/L) has been uncommonly reported in quetiapine clinical trials.
Maltese: Newtropenija severa (għadd tan-newtrofili <0.5 X 109/L) kienet irrappurtata b'mod mhux komuni b'quetiapine fil-provi kliniċi.
English: The average dose was 669 mg.
Maltese: Id-doża medja kienet 669 mg.
English: Extrapyramidal symptoms3
Maltese: Sintomi ekstrapiramidali3
English: Quetiapine is an atypical antipsychotic agent.
Maltese: Quetiapine huwa sustanza antipsikotika mhux tipika.
English: The frequencies of adverse events are ranked according to the following: Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare
Maltese: Komuni ħafna (>1/10), komuni (>1/100, <1/10), mhux komuni (>1/1000, <1/100, rari (>1/10,000, <1/1000) u rari ħafna (<1/10,000).
English: Antidepressant effect was seen at 150 and 300 mg/day in short-term trials as add-on therapy (with amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline and venlafaxine - see Section 5.1) and at 50 mg/day in short-term monotherapy trials.
Maltese: L-effett kontra d-depressjoni deher b'150 mg u 300 mg/jum fi provi qosra bħala terapija miżjuda (ma' amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline u venlafaxine - ara Sezzjoni 5.1) u 50 mg/kuljum fi provi qosra ta' monoterapija.
English: ¾Perform new EU Multi-Country Drug Utilisation Study (EU DUS) in accordance with an agreed protocol.
Maltese: ¾ Isir Studju ġdid dwar l-Użu tal-Mediċina minn Diversi Pajjiżi tal-UE (EU Multi-Country Drug Utilisation Study - EU DUS) f'konformità ma' protokoll miftiehem.
English: However in two 10-week placebo controlled quetiapine studies in the same patient population (n=710; mean age: 83 years; range: 56-99 years) the incidence of mortality in quetiapine treated patients was 5.5% versus 3.2% in the placebo group.
Maltese: Madankollu fi studji ta' 10 ġimgħat ikkontrollati bi plaċebo fl-istess popolazzjoni ta' pazjenti (n=710; età medja: 83 sena; medda: 56-99 sena) il-frekwenza ta' mortalità tal-pazjenti ikkurati b'quetiapine kienet 5.5% kontra 3.2% fil-grupp tal-plaċebo.
English: Concomitant administration of cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin and nefazodone, is contraindicated.
Maltese: L-għotja ta' impedituri ta' cytochrome P450, bħal impedituri ta' HIV-protease, sustanzi azole kontra lfungu, erythromycin, clarithromycin u nefazodone hija kontra-indikata (ara Sezzjoni 4.5).
English: Diabetes Mellitus 1,5,6, Psychiatric disorders Common:
Maltese: Dijabete Mellitus 1,5,6,
English: QT Prolongation:
Maltese: Titwil QT:
English: The 50 mg, 200 mg and 300 mg tablets also contain iron oxide yellow (E172) and the 50 mg tablets contain iron oxide red (E172).
Maltese: Il-pilloli ta' 50 mg, 200 mg, u 300 mg fihom ukoll iron oxide yellow (E172) u il-pilloli ta' 50 mg fihom iron oxide red (E172)
English: 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).
Maltese: Id-doża totali għall-ewwel erbat ijiem tat-terapija hija 50 mg (Jum 1), 100 mg (Jum 2), 200 mg (Jum 3) u 300 mg (Jum 4).
English: MT - Malta AstraZeneca UK Ltd Silk Road Business Park Macclesfield
Maltese: AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom