FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no clinically relevant differences between genders in the pharmacokinetics of lurasidone in a population pharmacokinetic analysis in patients with schizophrenia.
Maltese: Ma kienx hemm differenzi klinikament rilevanti fil-farmakokinetika ta' lurasidone f'analiżi tal-farmakokinetika tal-popolazzjoni f'pazjenti bi skiżofrenja.
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to18.6 mg lurasidone.
Maltese: Kull pillola miksija b'rita fiha lurasidone hydrochloride ekwivalenti għal 18.6 mg lurasidone.
English: Venous thromboembolism
Maltese: emboli tad-demm
English: Dopamine and serotonin are neurotransmitters (substances that allow nerve cells to communicate with each other) that are involved in the symptoms of schizophrenia.
Maltese: Dopamine u serotonin huma newrotrażmettituri (sustanzi li jippermettu liċ-ċelloli nervużi jikkomunikaw ma' xulxin) li huma involuti fis-sintomi ta' l-iskiżofrenja.
English: Vomiting Dyspepsia Salivary hypersecretion Dry mouth Upper abdominal pain Stomach discomfort
Maltese: • tkabbir mhux normali tas-sider, uġigħ fis-sider, sekrezzjoni ta' ħalib mis-sider
English: The most common adverse drug reactions (ADRs) (≥ 10%) were akathisia and somnolence, which were dose-related up to
Maltese: L-aktar reazzjonijiet avversi tal-mediċina komuni (ADRs - adverse drug reactions) (≥ 10%) kienu akatisja u ngħas, li sa 111 mg kuljum.
English: EU/1/14/913/015-021
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/913/015-021
English: During antipsychotic treatment, improvement in the patient's clinical condition may take a few days to some weeks.
Maltese: Waqt kura antipsikotika, titjib fil-kondizzjoni klinika tal-pazjent jista' jieħu min ftit jiem sa xi ġimgħat.
English: The maximum daily dose should not exceed 148 mg.
Maltese: Id-doża massima ta' kuljum m'għandhiex taqbeż 148 mg.
English: Flatulence
Maltese: Letarġija
English: Medicinal products with dopamine receptor antagonistic properties have been associated with extrapyramidal adverse reactions including rigidity, tremors, mask-like face, dystonias, drooling of saliva, drooped posture and abnormal gait.
Maltese: Prodotti mediċinali bi kwalitajiet antagonistiċi għar-riċetturi ta' dopamine kienu assoċjati ma' reazzjonijiet avversi ekstrapiramidali inkluż riġidità, rogħda, wiċċ qisu maskra, distonija, nixxija ta' bżieq mill-ħalq, qagħda mħattba u mixja mhux normali.
English: Lurasidone and its active metabolite ID-14283 both contribute to the pharmacodynamic effect at the dopaminergic and serotonergic receptors.
Maltese: Lurasidone u l-metabolit attiv tiegħu ID-14283 it-tnejn jikkontribwixxu għall-effett farmakodinamiku fir-riċetturi dopaminerġiċi u serotonerġiċi.
English: Hyperglycaemia
Maltese: taħt il-ġilda
English: (IC50>5.9 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2B6, CYP2C8, CYP2C9,
Maltese: In vitro, lurasidone ma wera l-ebda inibizzjoni diretta, jew dgħajfa (diretta jew dipendenti mill-ħin) (IC50>5.9 μM) tal-enzimi taċ-ċitokromju P450 (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, u CYP3A4.
English: • abnormal breast enlargement, breast pain, milk secretion from breasts
Maltese: • diffikulta biex torqod, għeja, aġitazzjoni u ansjetà
English: • muscle aches
Maltese: • vista mċajpra
English: • rash and itching
Maltese: Rash Ħakk
English: Joint stiffness Myalgia Neck pain Back pain
Maltese: Kif għandek tieħu Latuda
English: Grapefruit juice inhibits CYP 3A4 and may increase the serum concentration of lurasidone.
Maltese: Meraq tal-grejpfrut jinibixxi CYP 3A4 u jista' jżid il-konċentrazzjoni ta' lurasidone fis-serum.
English: Venous thromboembolism: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs -Frequency unknown.
Maltese: Każijiet ta' tromboemboliżmu fil-vini, inkluż każijiet ta' emboliżmu pulmonari u każijiet ta' trombożi fil-vini l-fondi kienu rrappurtati b'mediċini antipsikotċi -Frekwenza mhux magħrufa.
English: ul.
Maltese: Għeja
English: The pharmacokinetics of lurasidone in paediatric patients aged 6-17 years was generally comparable to those observed in adults.
Maltese: Ilfarmakokinetika ta' lurasidone f'pazjenti pedjatriċi b'età bejn 6-17-il sena kienet ġeneralment komparabbli ma' dawk osservati fl-adulti.
English: 0.1 mg/kg/day lurasidone hydrochloride, respectively, or on early embryonic development at an oral dose of 15 mg/kg/day lurasidone hydrochloride.
Maltese: Fil-firien, lurasidone ma kellu l-ebda effett fuq ir-riproduzzjoni maskili u femminili b'dożi orali ta' 150 u 0.1 mg/kg/kuljum ta' lurasidone hydrochloride, rispettivament, jew fuq l-iżvilupp bikri tal-embriju b'doża orali ta' 15 mg/kg/kuljum ta' lurasidone hydrochloride.
English: Lurasidone demonstrated superior efficacy compared with placebo across Phase 3 studies (see Table 2).
Maltese: Lurasidone wera effikaċja superjuri meta mqabbel mal-plaċebo tul l-istudji ta' Fażi 3 (ara Tabella 2).
English: Lurasidone does not impact concentrations of lithium.
Maltese: lurasidone hydrochloride.
English: N=121 N=116
Maltese: N=116
English: Statistically significant differences favouring lurasidone over placebo were shown for these endpoints for the total population studied, beginning at Week 2 and were maintained at each study visit through to the end of the study.
Maltese: Ġew murija differenzi statistikament sinifikanti li jiffavorixxu lurasidone fuq il-plaċebo għal dawn il-punti finali għal popolazzjoni totali li ġiet studjata, li bdew f'Ġimgħa 2 u ġew miżmuma f'kull viżta ta' studju sat-tmiem tal-istudju.
English: In this event, lurasidone, should be discontinued.
Maltese: F'dan il-każ, lurasidone, għandu jitwaqqaf.
English: In that study the rate of relapse over a 12-month period was 20% for lurasidone and 16% for risperidone.
Maltese: għall lurasidone u 16% għal risperidone.
English: Malta
Maltese: Wien
English: Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical involuntary movements, predominantly of the tongue and/or face.
Maltese: Prodotti mediċinali bi kwalitajiet antagonistiċi għar-riċetturi ta' dopamine kienu assoċjati mal-induzzjoni ta' diskajneżja ttardjata kkaratterizzata minn movimenti ritmiċi involuntarji, l-aktar tal-ilsien u/jew tal-wiċċ.
English: 37 mg 74 mg 111 mg 148 mg p-value
Maltese: Il-doża massima m'għandhiex taqbeż 148 mg darba kuljum.
English: • Latuda 37 mg film-coated tablets are white to off-white, film-coated round tablets debossed with “LB”
Maltese: • Latuda 37 mg pilloli miksija b'rita huma ta' lewn abjad sa abjad maħmuġ, pilloli tondi miksija b'rita, imnaqqxa b'"LB"
English: Concomitant administration of BCRP substrates may result in increases in the plasma concentrations of these substrates.
Maltese: Għoti konkomitanti ta' substrati BCRP jista' jirriżulta f'żidiet fil-konċentrazzjonijiet fil-plażma ta' dawn is-substrati.
English: Tardive dyskinesia
Maltese: Diskajneżja ttardjata
English: These effects were due to the hyperprolactinemia following lurasidone treatment, affecting the oestrous cycle and copulatory behaviour as well as the maintenance of corpus luteum of the female rats, resulting in a decrease in implantation and the number of live foetuses.
Maltese: Dawn l-effetti kienu kkawżati minn iperprolaktinimja wara kura b'lurasidone, li taffettwa ċ-ċiklu estrus u l-imġiba kopulatorja kif ukoll il-manteniment ta' korpus luteum tal-firien femminili, li wasslu għal tnaqqis fl-impjantazzjoni u fin-numru ta' feti ħajjin.
English: Tel: + 420 546 123 111
Maltese: Tel: + 420 546 123 111 info@angelini.cz
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with lurasidone and preventive measures undertaken.
Maltese: Peress li pazjenti kkurati b'antipsikotiċi ta' spiss ikollhom fatturi akkwistati ta' riskju għal VTE, il-fatturi possibbli kollha ta' riskju għal VTE għandhom jiġu identifikati qabel u waqt il-kura b'lurasidone u għandhom jittieħdu miżuri ta' prevenzjoni.
English: Latuda 18.5 mg film-coated tablets lurasidone
Maltese: Latuda 18.5 mg pilloli miksija b'rita lurasidone
English: Grapefruit juice inhibits CYP3A4 and may increase the serum concentration of lurasidone.
Maltese: Meraq tal-grejpfrut jinibixxi CYP3A4 u jista' jżid il-konċentrazzjoni ta' lurasidone fis-serum.
English: • are taking medicines which may affect the level of lurasidone in your blood such as: medicines for fungal infections such as itraconazole, ketoconazole (except as a shampoo), posaconazole or voriconazole medicines for an infection such as the antibiotic clarithromycin or telithromycin medicines for HIV infections such as cobicistat, indinavir, nelfinavir, ritonavir, and saquinavir boceprevir, and telaprevir (medicines for chronic hepatitis) nefazodone (a medicine for depression) rifampicin (a medicine for tuberculosis) carbamazepine, phenobarbital and phenytoin (medicines for seizures) St John's wort (Hypericum perforatum) (herbal medicine for depression).
Maltese: - boceprevir, u telaprevir (mediċini għall-epatite kronika) - nefazodone (mediċina għad-depressjoni) rifamicin (mediċina għat-tuberkulosi) carbamazepine, phenobarbital u phenytoin (mediċini għall-aċċessjonijiet) St John's wort (Hypericum perforatum) (mediċina mill-ħxejjex għad-depressjoni).
English: Latuda film-coated tablets are available in pack sizes containing 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1,
Maltese: Latuda pilloli miksija b'rita huma disponibbli f'daqsijiet ta' pakketti li fihom 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 jew 98 x 1 pillola miksija b'rita f'folji magħmulin minn aluminju/aluminju mtaqqab biex tkun tista' tinqata' doża waħda.
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to 74.5 mg lurasidone.
Maltese: Kull pillola miksija b'rita fiha lurasidone hydrochloride ekwivalenti għal 74.5 mg lurasidone.
English: This medicine is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Maltese: Din il-mediċina mhux irrakkomandata għal tfal u adolexxenti taħt 18 il sena minħabba nuqqas ta' dejta f'dawn il-pazjenti.
English: Baseline Mean (SD) LS Mean Change (SE) Treatment Difference vs. placebo
Maltese: 3 (1.08) Differenza fil-Kura vs plaċebo
English: However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see “Renal impairment” below).
Maltese: Madankollu, peress li pazjenti anzjani jista' jkollhom funzjoni renali mnaqqsa, aġġustamenti fid-doża jistgħu jkunu meħtieġa skont l-istat tal-funzjoni renali tagħhom (ara "Indeboliment renali" taħt).
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to 37.2 mg lurasidone.
Maltese: Kull pillola miksija b'rita fiha lurasidone hydrochloride ekwivalenti għal 37.2 mg lurasidone.
English: • problems with erections
Maltese: • problemi biex ikollok erezzjoni
English: Therefore, lurasidone can be coadministered with oral contraceptives.
Maltese: Għalhekk, lurasidone jista' jingħata flimkien ma' kontraċettivi orali.
English: Cardiovascular disorders/QT prolongation
Maltese: mestruwazzjoni (amenorrea) jew disfunzjoni erettili
English: Coadministration of lurasidone with lithium indicated that lithium had clinically negligible effects on the pharmacokinetics of lurasidone, therefore no dose adjustment of lurasidone is required when coadministered with lithium.
Maltese: Amministrazzjoni konkomitanti ta' lurasidone ma' lithium indika li lithium kellu effetti klinikament negliġibbli fuq il-farmakokinetika ta' lurasidone, għalhekk mhux meħtieġ aġġustament fid-doża ta' lurasidone meta jingħata flimkien ma' lithium.
English: Patients were randomized to flexibly dosed lurasidone 18-74 mg once daily or placebo.
Maltese: Il-pazjenti kienu magħżula b'mod każwali għal lurasidone 18-74 mg li jingħata f'doża flessibbli darba kuljum jew għal plaċebo,
English: Limited data are available in elderly people treated with higher doses of lurasidone.
Maltese: Dejta limitata hija disponibbli f'persuni anzjani kkurati b'dożi ogħla ta' lurasidone.
English: Nasopharyngitis
Maltese: Tipjip
English: • nightmares
Maltese: • aċċessjonijiet
English: • enlarged breasts in male (gynecomastia), milky nipple discharge (galactorrhea), absence of menstruation (amenorrhea) or erectile dysfunction
Maltese: • livelli baxxi ta' sodium fid-demm li jistgħu jikkawżaw għeja u konfużjoni, movimenti involontarji tal-muskoli, aċċessjonijiet u koma (iponatremija).
English: The primary efficacy endpoint was defined as the mean change from baseline to Week 6 in Children's Depression Rating Scale, Revised (CDRS-R) Total Score.
Maltese: Il-punt finali primarju tal-effikaċja kien definit bħala l-bidla medja mil-linja bażi sa Ġimgħa 6 filPunteġġ Totali tal-Iskala tal-Klassifikazzjoni tad-Depressjoni fit-Tfal, Riveduta (CDRS-R, Children's
English: • medicines for Parkinson's disease and restless legs syndrome (e.g. levodopa) as this medicine can reduce their effects
Maltese: • mediċini għall-marda ta' Parkinson u għas-sindrome ta' riġlejn jiċċaqalqu (eż. levodopa) peress li din il-mediċina tista' tnaqqas l-effetti tagħhom
English: Lurasidone is a substrate of P-gp and BCRP in vitro and the in vivo relevance of this is unclear.
Maltese: Trasportaturi Lurasidone huwa sottostrat ta' P-gp u BCRP in vitro u r-rilevanza ta' dan in vivo mhix ċara.
English: You may experience sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats.
Maltese: Jista' jkollok ngħas, għeja, movimenti mhux normali tal-ġisem, problemi bil-wieqfa u biex timxi, sturdament ikkawżat minn pressjoni baxxa, u taħbit tal-qalb mhux normali.
English: • reduced appetite
Maltese: • aptit imnaqqas
English: Dysuria
Maltese: Disartrija
English: It also blocks α2c-adrenergic receptors and α2a-adrenergic receptors with a binding affinity of 10.8 and 40.7 nM respectively.
Maltese: Jimblokka wkoll ir-riċetturi α2c-adrenerġiċi u α2a-adrenerġiċi b'affinità ta' rbit ta' 10.
English: Caution should be exercised when treating patients ≥65 years of age with higher doses of lurasidone.
Maltese: Għandu jkun hemm attenzjoni meta jiġu kkurati pazjenti b'età ta' ≥65 sena b'dożi ogħla ta' lurasidone.
English: The
Maltese: ISEM
English: The maximum daily dose in moderate hepatic impairment patients should not exceed 74 mg and in severe hepatic impairment patients should not exceed 37 mg once daily.
Maltese: Id-doża massima ta' kuljum f'pazjenti b'indeboliment epatiku moderat m'għandhiex taqbeż 74 mg u f'pazjenti b'indeboliment epatiku sever m'għandhiex taqbeż 37 mg darba kuljum.
English: Contents of the pack and other information What Latuda contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Latuda
English: A starting dose of 18.5 mg is recommended and the maximum dose of lurasidone should not exceed 74 mg once daily in combination with moderate CYP3A4 inhibitors.
Maltese: Doża tal-bidu ta' 18.5 mg hija rrakkomandata u d-doża massima ta' lurasidone m'għandhiex taqbeż 74 mg darba kuljum meta flurasidone jinghata flimkien ma' inibituri moderati ta' CYP3A4.
English: • feeling of restlessness and inability to sit still • sleepiness.
Maltese: • sensazzjoni ta' aġitazzjoni u inabbiltà biex ma tiċċaqlaqx
English: These findings are common in rodents treated with antipsychotic medicinal products with dopamine D2 blocking activity and are considered to be rodent-specific.
Maltese: Dawn is-sejbiet huma komuni f'annimali gerriema kkurati bi prodotti mediċinali antipsikotiċi b'attività li timblokka dopamine D2 u huma kkunsidrati li huma speċifiċi għall-annimali gerriema.
English: In a dose range finding study in pregnant rats, 150 mg/kg/day lurasidone hydrochloride caused fetal growth retardation without signs of teratogenicity.
Maltese: Doża waħda ta' 10 mg/kg ta' lurasidone hydrochloride lill-firien tqal wasslet għall-esponiment fil-feti.
English: • Rhabdomyolysis which is the breakdown of muscle fibres that leads to the release of muscle fibre contents (myoglobin) into the bloodstream, seen as muscle pain, being sick, being confused, an abnormal heart rate and rhythm, and possibly dark urine
Maltese: • Rabdomijolisi li hija t-tifrik ta' fibri tal-muskoli li jwassal għar-rilaxx tal-kontenut tal-fibra tal-muskoli (mijoglobina) fiċ-ċirkolazzjoni tad-demm, osservat bħala uġigħ fil-muskoli, rimettar, tħossok konfuż, rata u ritmu tal-qalb mhux normali, u possibilment awrina skura
English: Hereford
Maltese: Treddigħ
English: 1 x 1 tablet (unit dose)
Maltese: Daqs tal-pakkett folja (alu/alu) 1 x 1 pillola (doża waħda)
English: MA (EU) Number Invented name Strength Pharmaceutical form Route of administration Immediate Packaging Package size
Maltese: (ivvintat) Qawwa Għamla farmaċewtika
English: Annex V
Maltese: Anness V
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder):
Maltese: Implimentazzjoni tal-ftehim mill-Istati Membri (sottomissjoni tal-varjazzjoni mid-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq):
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Maltese: Bgħit tat-traduzzjonijiet tal-annessi tal-ftehim lillAwtoritajiet Kompetenti Nazzjonali:
English: 20 February 2014
Maltese: 20 ta' Frar 2015
English: Adoption of CMDh agreement:
Maltese: Adozzjoni tal-ftehim tal-Grupp ta' koordinazzjoni għal proċedura tar-rikonoxximent reċiproku u lproċedura deċentralizzata - Bniedem (CMDhCoordination Group for Mutual Recognition and Decentralised Procedures - Human):
English: Ref. EMEA/CHMP/384879/2008
Maltese: EMEA/CHMP/554685/2008
English: London, 8 October 2008 Doc.
Maltese: Londra, 8 ta' Ottubru 2008 Dok. Ref.
English: The Marketing Authorisation Holder provided supplementary information on 28 January 2008 and 28 April 2008.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta informazzjoni supplimentari fit-28 ta' Jannar 2008 u fit-28 ta' April 2008.
English: Risperdal Consta and associated names is an anti-psychotic, indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics.
Maltese: Risperdal Consta u ismijiet assoċjati huwa antipsikotiku, indikat għat-trattament ta' manutenzjoni ta' skizofrenija f'pazjenti li fil-preżent huma stabbilizzati b'antipsikotiċi orali.
English: This medicinal product belongs to the list of products identified in 2007 for SPC harmonisation.
Maltese: Dan il-prodott mediċinali jappartjeni għal-lista ta' prodotti identifikati fl-2007 għall-armonizzazzjoni talSPC.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Risperdal Consta and associated names International Non-Proprietary Name (INN): risperidone
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA RIFERIMENT SKONT L-ARTIKOLU 30 GĦAL Risperdal Consta u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): risperidone
English: On 24 July 2007 the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Risperdal Consta and associated names.
Maltese: Fl-24 ta' Lulju 2007, il-Kummissjoni Ewropea ppreżentat riferiment lill-EMEA skont l-Artikolu 30 tadDirettiva 2001/83/KE, kif emendata, sabiex jiġu armonizzati s-Sommarji tal-Karatteristiċi tal-Prodott (SPC), it-Tikketta u l-Fuljett ta' Tagħrif awtorizzati fuq livell nazzjonali, tal-prodott mediċinali Risperdal Consta u ismijiet assoċjati.
English: The procedure started on 20 September 2007.
Maltese: Il-proċedura nbdiet fl-20 ta' Settembru 2007.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Risperdal Consta and associated names approved across EU Member States, with respect to the indication, the special warnings and precautions for use and the interaction with other medicinal products and other forms of interaction.
Maltese: Il-bażi għar-riferiment kien li kien hemm diverġenzi fis-Sommarji tal-Karatteristiċi tal-Prodott (SPC) ta' Risperdal Consta u ismijiet assoċjati approvati madwar l-Istati Membri tal-UE, fir-rigward talindikazzjoni, it-twissijiet speċjali u l-prekawzjonijiet għall-użu u l-interazzjoni ma' prodotti mediċinali oħrajn u ma' forom ta' interazzjoni oħrajn.
English: The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Risperdal Consta and associated names.
Maltese: Is-CHMP ta opinjoni pożittiva fl-24 ta' Lulju 2008 u rrakkomanda l-armonizzazzjoni tal-SPC, it-Tikketta u l-Fuljett ta' Tagħrif għal Risperdal Consta u l-ismijiet assoċjati.
English: During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Maltese: Matul il-laqgħa tiegħu ta' Lulju 2008, is-CHMP, fid-dawl tad-dejta ġenerali ppreżentata u tad-diskussjoni xjentifika fi ħdan il-Kumitat, kien tal-opinjoni li l-proposta għall-armonizzazzjoni tal-SPC, it-Tikketta u lFuljett ta' Tagħrif kienet waħda aċċettabbli u li dawn għandhom jiġu emendati.
English: It is available as prolonged release powder and solvent for suspension for intramuscular use.
Maltese: Jiġi bħala trab b'rilaxx prolungat u bħala solvent għal sospensjoni sabiex jingħata fil-muskoli.
English: A total of 34 grade III (14.4%) and 2 grade IV (0.8%) were reported.
Maltese: Total ta' 34 tal-grad III (14.4%) u 2 tal-grad IV (0.8%) ġew irrapportati.
English: Test dose
Maltese: Doża tat-test
English: The MAH reported that 25 events were related to ferrix carboxymaltose (20 grade I, 2 grade II, 2 grade III and 1 grade IV), 2 events were unlikely related to ferrix carboxymaltose (1 grade II and 1 grade IV), 9 events were not related to ferrix carboxymaltose (6 grade I, 1 grade II and 2 grade III).
Maltese: Il-MAH irrapporta li 25 avveniment kienu relatati ma' ferrix carboxymaltose (20 tal-grad I, 2 talgrad II, 2 tal-grad III u 1 tal-grad IV), 2 avvenimenti probabbilment ma kinux relatati ma' ferrix carboxymaltose (1 tal-grad II u 1 tal-grad IV), 9 avvenimenti ma kinux relatati ma' ferrix carboxymaltose (6 tal-grad I, 1 tal-grad II u 2 tal-grad III).
English: In conclusion the post-marketing data are in accordance with the known safety profile of ferric carboxymaltose.
Maltese: Bħala konklużjoni d-dejta wara t-tqegħid fis-suq hija skont il-profil tas-sigurtà magħruf ta' ferric carboxymaltose.
English: A total of 33 publications reporting on the safety of LMWID were identified.
Maltese: Kienu identifikati total ta' 33 pubblikazzjoni li rrapportaw dwar is-sigurtà ta' LMWID.
English: Since the time of authorisation until 29 February 2012, a total of 587 case reports have been received yielding an ADR reporting rate of 0.003 % (which corresponds to 1093 case reports for 100,000 patients-days).
Maltese: Sa minn żmien l-awtorizzazzjoni sad-29 ta' Frar 2012, kienu riċevuti total ta' 587 rapport ta' każijiet li taw rata ta' rapportar ta' ADRs ta' 0.003 % (li tikkorrispondi għal 1093 rapport ta' każijiet għal 100,000 pazjent-jiem).
English: Other control patients have been grouped into those receiving other IV iron preparations (N=3,364), oral iron (N=887), placebo (N=256) or standard medical care [(SMC), N=159].
Maltese: ħadid orali (N=887), plaċebo (N=256) jew kura medika standard [(SMC), N=159].
English: Risk minimisation measures and other pharmacovigilance activities
Maltese: Miżuri għall-minimizzazzjoni tar-riskji u attivitajiet oħra ta' farmakoviġilanza