FrancophonIA/ELRC3.0 huggingface dataset:
English: Ciclosporin is contraindicated for some HMG-CoA reductase inhibitors (statins) due to the CYP3A4 and/or Pgp inhibitory potential of ciclosporin.
Maltese: Ciclosporin huwa kontraindikat għal xi inibituri ta' HMG-CoA reductase (statins) minħabba lpotenzjal inibitorju ta' CYP3A4 u/jew Pgp ta' ciclosporin.
English: The MAH confirmed that the storage conditions in the SmPCs of Sandimmun soft gelatin capsules and oral solutions are already aligned with the requirements set in the Guideline on Declaration of Storage Conditions (CPMP/QWP/609/96/Rev 2 dated 19 Nov 2007).
Maltese: Il-MAH ikkonferma li l-kundizzjonijiet għall-ħażna fl-SmPCs ta' Sandimmun kapsuli tal-ġelatina ratba u soluzzjonijiet orali huma diġà allinjati mar-rekwiżiti stabbiliti fil-Linja Gwida dwar idDikjarazzjoni ta' Kondizzjonijiet għall-Ħażna (CPMP/QWP/609/96/Rev 2 datata 19 ta' Nov 2007).
English: In October 2010, Sandimmun Neoral was included in the list of products for Summary of Product Characteristics (SmPC) harmonization, requested by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Maltese: F'Ottubru 2010, Sandimmun Neoral kien inkluż fil-lista ta' prodotti għall-armonizzazzjoni tasSommarju tal-Karatteristiċi tal-Prodott (SmPC), mitluba mis-CMD(h), skont l-Artikolu 30(2) tadDirettiva 2001/83/KE, kif emendata.
English: Sandimmun Neoral is available as Sandimmun Neoral soft gelatin capsules (10 mg, 25 mg, 50 mg and 100 mg) and Sandimmun Neoral oral solution, 100 mg/ml.
Maltese: Sandimmun Neoral huwa disponibbli bħala Sandimmun Neoral kapsuli tal-ġelatina ratba (10 mg, 25 mg, 50 mg u 100 mg) u Sandimmun Neoral soluzzjoni orali, 100 mg/ml.
English: The MAH confirmed that the stability studies have been performed at the long term conditions at 25°C/60%RH and accelerated conditions also at 40°C/75% RH.
Maltese: Il-MAH ikkonferma li l-istudji dwar l-istabbiltà kienu saru filkundizzjonijiet fit-tul f'25°C/60%RH u f'kundizzjonijiet aċċellerati wkoll f'40°C/75% RH.
English: The MAH proposed wordings for the sub-sections “Absorption, Distribution, Biotransformation and Elimination, Special populations and Paediatric population.” based on a harmonized text already approved in 13 EU countries.
Maltese: Il-MAH ippropona kliem għas-sottosezzjonijiet "Assorbiment, Distribuzzjoni, Bijotrasformazzjoni u Eliminazzjoni, Popolazzjonijiet speċjali u Popolazzjoni pedjatrika" abbażi ta' test armonizzat diġà approvat fi 13-il pajjiż tal-UE.
English: With regards to the paragraphs concerning Medical supervision, Lymphomas and other malignancies, Geriatrics, Hyperkalaemia, Hypomagnesemia and Hyperuricaemia, Special excipients, the MAH proposed the CSP wording as the harmonised SmPC text.
Maltese: Fir-rigward tal-paragrafi dwar Superviżjoni medika, Linfomi u tumuri malinni oħra, Ġerjatrija, Iperkalimja, Ipomagnesimja u Iperuriċemija, Eċċipjenti speċjali, il-MAH ippropona l-kliem tas-CSP bħala t-test armonizzat tal-SmPC.
English: However the CHMP considered that this paragraph should be complemented with recommendations for further controls to be made, e.g. of liver function, bilirubin, serum electrolytes and blood pressure and that it is preferred to use glomerular filtration rate determined by a reliable and reproducible method rather than serum creatinine.
Maltese: Madankollu s-CHMP qies li dan il-paragrafu għandu jiġi kkumplimentat b'rakkomandazzjonijiet biex isiru aktar kontrolli, eż. tal-funzjoni tal-fwied, tal-bilirubina, l-elettroliti fis-serum u l-pressjoni tad-demm u li preferibbilment tintuża rata ta' filtrazzjoni glomerulari determinata minn metodu affidabbli u riproduċibbli aktar milli bil-krejatinina fis-serum.
English: The MAH proposed wordings for the sub-sections “Food interactions, Drug interactions, Drugs that decrease ciclosporin levels, Drugs that increase ciclosporin levels, Other relevant drug interactions, Recommendations, Paediatric population and Other relevant drug interactions.”
Maltese: Il-MAH ippropona kliem għas-sottosezzjonijiet “Interazzjonijiet mal-ikel, Interazzjonijiet talmediċina, Mediċini li jnaqqsu l-livelli ta' ciclosporin, Mediċini li jżidu l-livelli ta' ciclosporin, Interazzjonijiet rilevanti oħra tal-mediċina, Rakkomandazzjonijiet, Popolazzjoni pedjatrika u Interazzjonijiet rilevanti oħra tal-mediċina.
English: European controlled double-blind trials used 5 mg/kg/d that allowed a downward titration to find the maximum tolerated dose.
Maltese: Provi bi blindaġġ doppju u kkontrollati Ewropej użaw 5 mg/kg/jum li ppermetta titrazzjoni ‘l isfel biex tinstab id-doża massima tollerata.
English: • Sandimmum and associated names 50mg/ml concentrate for solution for infusion
Maltese: • Sandimmum u ismijiet assoċjati 50mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: In comparison to Sandimmun (oil-based formulation of ciclosporin), Sandimmun Neoral (microemulsified formulation) provides improved dose linearity of ciclosporin exposure, a more consistent absorption profile and shows less influence from concomitant food intake and from diurnal rhythm.
Maltese: Meta mqabbel ma' Sandimmun (formulazzjoni ta' ciclosporin b'bażi ta' żejt), Sandimmun Neoral (formulazzjoni mikroemulsifikata) jipprovdi titjib fil-linearità tad-doża fl-espożizzjoni għal ciclosporin, profil ta' assorbiment aktar konsistenti u juri anqas influwenza mit-teħid konkomitanti talikel u mir-ritmu tal-ġurnata.
English: The CHMP therefore requested the MAH to justify the positive benefit risk for all nephrotic conditions except the primary minimal change glomerulonephritis, primary focal segmental glomerulosclerosis, or primary membranous glomerulonephritis.
Maltese: Għalhekk is-CHMP talab lill-MAH jiġġustifika l-benefiċċju-riskju pożittiv għall-kondizzjonijiet nefrotiċi kollha ħlief għal glomerulonefrite primarja b'tibdil minimu, glomerulosklerożi segmentali fokali primarja, jew glomerulonefrite membrana primarja.
English: The approach taken by the MAH to achieve a proposed harmonized SmPC with regard to the safety sections of the SmPC (sections 4.3 to 4.9) was to use as a basis the most recently updated MAH's Core Data Sheet (CDS) of Sandimmun Neoral, dated 13 February 2012 (as justified by a review of submitted legacy studies, and identified literature references) and the finalized Core Safety profile (CSP) from the last PSUR 13 work sharing (WS) procedure (EE/H/PSUR/0007/001).
Maltese: L-approċċ li ħa l-MAH sabiex jinkiseb SmPC armonizzat propost fir-rigward tas-sezzjonijiet talSmPC dwar is-sigurtà (sezzjonijiet 4.3 sa 4.9) kien li bħala bażi tintuża l-Iskeda tad-Dejta Ewlenija (CDS) tal-MAH aġġornata l-aħħar ta' Sandimmun Neoral, datata 13 ta' Frar 2012 (kif ġustifikata mirreviżjoni tal-istudji storiċi sottomessi, u r-referenzi identifikati fil-letteratura) u l-profil tas-Sigurtà Ewlenija (CSP) iffinalizzat mill-aħħar proċedura ta' qsim tax-xogħol (WS) 13 tal-PSUR (EE/H/PSUR/0007/001).
English: The control groups were either using placebo, or azathioprine, or D-penicillamine.
Maltese: Il-gruppi ta' kontroll kienu qed jużaw jew plaċebo, jew azathioprine, jew D-penicillamine.
English: The dossier of Sandimmun was used as a basis of the review as the dossier supporting the approval of the new ciclosporin formulation (Sandimmun Neoral) was based on pharmacokinetics evaluation that demonstrated equivalence between the 2 forms of ciclosporin (oil-based formulation versus microemulsified formulation).
Maltese: Id-dossier ta' Sandimmun intuża bħala bażi tar-reviżjoni peress li d-dossier li kien jappoġġja l-approvazzjoni talformulazzjoni l-ġdida ta' ciclosporin (Sandimmun Neoral) kien ibbażat fuq evalwazzjoni farmakokinetika li wriet ekwivalenza bejn iż-żewġ forom ta' ciclosporin (formulazzjoni b'bażi ta' żejt kontra formulazzjoni mikroemulsifikata).
English: This was confirmed within the framework of this article 30 procedure.
Maltese: Dan kien ikkonfermat fil-qafas ta' din il-proċedura skont l-artikolu 30.
English: Renal dysfunction above the critical threshold, defined as creatinine increased by 3050% over baseline, was less of a problem when starting with a dose of 2.5 mg/kg/day.
Maltese: Disfunzjoni renali 'l fuq mil-limitu kritiku, definita bħala żieda fil-krejatinina ta' 30-50% fuq il-linja bażi, kienet anqas ta' problema meta d-doża nbdiet b'2.5 mg/kg/jum.
English: Sandimmun Neoral was first registered in Germany in February 1993 and is available in the EU as 10 mg, 25 mg, 50 mg, 100 mg soft gelatin capsules and 100 mg/ml oral solution.
Maltese: Sandimmun Neoral ġie rreġistrat l-ewwel darba fil-Ġermanja fi Frar 1993 u huwa disponibbli fl-UE bħala kapsuli tal-ġelatina ratba ta' 10 mg, 25 mg, 50 mg, 100 mg u soluzzjoni orali ta' 100 mg/ml.
English: From the data provided and other published data the CHMP concluded that benefit-risk ratio for ciclosporin in treatment of endogenous refractory uveitis, including Behçet uveitis, is positive.
Maltese: Mid-dejta pprovduta u dejta oħra ppubblikata s-CHMP ikkonkluda li l-proporzjon tal-benefiċċju-riskju għal ciclosporin fil-kura ta' uveite refrattorja endoġena, inkluża l-uveite ta' Behçet, huwa pożittiv.
English: Regarding the sub-sections Doses/side effects, Infections and infestations and Neoplasms, Other ADRs from post-marketing experience, the MAH proposed align the harmonized SmPC text with the agreed CSP.
Maltese: Fir-rigward tas-sottosezzjonijiet Dożi/effetti sekondarji, Infezzjonijiet u infestazzjonijiet u Neoplażmi, ADRs oħra mill-esperjenza ta' wara t-tqegħid fis-suq, il-MAH ippropona li t-test armonizzat talSmPC jiġi armonizzat mas-CSP miftiehem.
English: However concerning HMG CoA reductase inhibitors (statins), the CHMP agreed that a strict contraindication may not be warranted, however, information in section 4.4 should be strengthened.
Maltese: Madankollu fir-rigward tal-inibituri ta' HMG CoA reductase (statins), is-CHMP qabel li jista' ma jkunx hemm ilħtieġa ta' kontraindikazzjoni stretta, madankollu, l-informazzjoni fis-sezzjoni 4.4 għandha tiġi msaħħa.
English: To achieve a harmonized SmPC, the MAH used the wording that is common to national SmPCs in the majority of MSs and the MAH's Core Data Sheet (CDS) for Sandimmun Neoral (dated 13 February 2012), as well as submitted legacy studies and literature references.
Maltese: Biex jinkiseb SmPC armonizzat, il-MAH uża l-kliem komuni għall-SmPCs nazzjonali fil-maġġoranza tal-Istati Membri (SM) u fl-Iskeda tad-Dejta Ewlenija (CDS) tal-MAH għal Sandimmun Neoral (datata 13 ta' Frar 2012), kif ukoll studji storiċi ppreżentati u referenzi għal-letteratura.
English: The MAH considered that the information included in the proposed harmonized label provided relevant information to the prescribing physician to optimize patient management.
Maltese: Il-MAH qies li l-informazzjoni inkluża fit-tikketta armonizzata proposta kienet tipprovdi informazzjoni rilevanti lit-tabib li jippreskrivi biex tiġi ottimizzata l-ġestjoni talpazjent.
English: Section 4.2 - Posology and method of administration
Maltese: Sezzjoni 4.6 - Tqala u Treddigħ
English: The MAH's proposed indication wording for nephritic syndrome is approved in 16 EU countries.
Maltese: Il-kliem tal-indikazzjoni propost mill-MAH għall-indikazzjoni tas-sindromu nefrotiku huwa approvat f'16-il pajjiż tal-UE.
English: Due to the divergent national decisions taken by Member States (MS) concerning the authorization of Sandimmun Neoral (and associated names), the European Commission (EC) notified the EMA/CHMP secretariat of an official referral under Article 30(2) of Directive 2001/83/EC as amended, to resolve divergences amongst the nationally authorised Sandimmun Neoral SmPCs across the EU/EEA region.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti li ttieħdu millIstati Membri (SM) dwar l-awtorizzazzjoni ta' Sandimmun Neoral (u ismijiet assoċjati), ilKummissjoni Ewropea (KE) innotifikat is-segretarjat tal-EMA/CHMP dwar riferiment uffiċjali skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE kif emendata, biex jiġu riżolti d-diverġenzi fost l-SmPCs ta' Sandimmun Neoral awtorizzati b'mod nazzjonali madwar ir-reġjun tal-UE/ŻEE.
English: Extensive information was provided by the MAH, including the dosages used in clinical studies that supported the approval of Sandimmun and Sandimmun Neoral in the bone marrow transplant indications.
Maltese: Il-MAH ipprovda informazzjoni estensiva, inkluż id-dożi użati fl-istudji kliniċi li appoġġaw lapprovazzjoni ta' Sandimmun u Sandimmun Neoral fl-indikazzjonijiet għal trapjant tal-mudullun.
English: In conclusion, based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon and adopted harmonised sets of PI documents for the various presentations of Sandimmun and associated names.
Maltese: Bħala konklużjoni, abbażi tal-valutazzjoni tal-proposta tal-MAH, it-tweġibiet għal-LoQ, il-LoOI u wara d-diskussjonijiet tal-kumitat, is-CHMP qabel dwar u adotta settijiet armonizzati ta' dokumenti tal-PI għad-diversi preżentazzjonijiet ta' Sandimmun u ismijiet assoċjati.
English: In addition, the CHMP requested the MAH to provide a clear rationale for having slightly different description of pharmacodynamic section in Sandimmun (both oral and injection) vs Sandimmun Neoral versions of SmPCs.
Maltese: Barra minn hekk, is-CHMP talab lill-MAH jipprovdi raġuni ċara għaliex kellu deskrizzjoni kemxejn differenti tas-sezzjoni tal-farmakodinamika f'Sandimmun (kemm orali kif ukoll injezzjoni) kontra lverżjonijiet tal-SmPCs ta' Sandimmun Neoral.
English: This approach was acceptable to the CHMP and final wordings in sections 4.2 and 4.4.were agreed accordingly.
Maltese: Dan l-approċċ kien aċċettabbli għas-CHMP u l-kliem finali fissezzjonijiet 4.2 u 4.4.kien maqbul kif xieraq.
English: The MAH proposed the following wording for this indication: “Sandimmun is indicated in patients with severe atopic dermatitis when systemic therapy is required.” The MAH's proposed indication wording for the Atopic dermatis is approved in 15 EU countries.
Maltese: Il-MAH ippropona l-kliem li ġej għal din l-indikazzjoni: “Sandimmun huwa indikat f'pazjenti b'dermatite atopika severa meta tkun meħtieġa terapija sistemika.”
English: As recorded in the minutes of the prereferral meeting held on 27 July 2011, regarding the approach to label harmonisation, the Agency agreed with the MAH's proposal to use the SmPC wording that is common in the majority of the Members States, the Sandimmun and Sandimmun Neoral CDSs as justified by the review of legacy studies and literature references.
Maltese: Kif irreġistrat fil-minuti tal-laqgħa ta' qabel ir-riferiment li saret fis-27 ta' Lulju 2011, dwar l-approċċ għall-armonizzazzjoni tat-tikketti, l-Aġenzija qablet mal-proposta tal-MAH li juża l-kliem fl-SmPC li huwa komuni fil-maġġoranza talIstati Membri, is-CDSs ta' Sandimmun u Sandimmun Neoral kif iġġustifikati mir-reviżjoni ta' studji storiċi u referenzi għal-letteratura.
English: As an outcome of this full review, both CDSs were finalized with a release date of 13 February 2012.
Maltese: B'riżultat ta' din ir-reviżjoni sħiħa, iż-żewġ CDSs ġew iffinalizzati b'data ta' rilaxx tat-13 ta' Frar 2012.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation
Maltese: Anness II Konklużjonijiet xjentifiċi u raġunijiet għall-varjazzjoni fit-termini talAwtorizzazzjoni għat-Tqegħid fis-Suq
English: In that context, a thorough comparison of the Feb 2011 agreed CSP information and the safety sections of the newly released CDSs was performed by the MAH.
Maltese: F'dak il-kuntest, il-MAH wettaq tqabbil bir-reqqa tal-informazzjoni maqbula tas-CSP ta' Frar 2011 u s-sezzjonijiet dwar is-sigurtà tas-CDSs li kienu għadhom kif ġew rilaxxati.
English: The MAH proposed a wording for recommendations related to the switch between Sandimmun and Sandimmun Neoral in accordance with the approved wording of 9 countries.
Maltese: Il-MAH ippropona kliem għal rakkomandazzjonijiet relatati mal-qalba bejn Sandimmun u Sandimmun Neoral skont il-kliem approvat ta' 9 pajjiżi.
English: The rationale given by the MAH for the proposed indication was based on the following data: the initial pilot study in active rheumatoid arthritis used a dose of 10 mg/kg/day, half the dose used in solid organ transplantation at that time.
Maltese: Ir-raġuni mogħtija mill-MAH għall-indikazzjoni proposta kienet ibbażata fuq id-dejta li ġejja: l-istudju pilota inizjali fl-artrite rewmatika attiva uża doża ta' 10 mg/kg/kuljum, nofs id-doża użata fi trapjant ta' organu solidu dak iż-żmien.
English: In addition, a clarification of the B/R of ciclosporin in prevention of graft rejection after nonmyloablative stem cell transplantation was also requested by the CHMP; the CHMP reviewed the MAH's position and considered unnecessary to specify myeloablative vs. non-myeloablative stem cell transplantation in the Ciclosporin indication.
Maltese: Ciclosporin ġie studjat b'mod estensiv f'diversi provi kliniċi fuq pazjenti bl-artrite rewmatika li għalihom terapija konvenzjonali mhijiex effettiva jew mhux adatta, kif ukoll f'ħafna studji ppubblikati li rrapportaw lużu ta' ciclosporin f'din l-indikazzjoni.
English: Switching from Sandimmun to Sandimmun Neoral
Maltese: III għal Sandimmum u ismijiet assoċjati (ara Anness I).
English: The CHMP also raised questions regarding the risk of aggravation of the neurological manifestations of Behcet's disease by Ciclosporin.
Maltese: Is-CHMP qajjem ukoll tħassib dwar ir-riskju ta' aggravar tal-manifestazzjonijiet newroloġiċi talmarda ta' Behcet b'Ciclosporin.
English: The MAH explained that shelf life periods were not harmonised and proposed to follow the safest approach to Sandimmun (to fix 36 months period) and the last reduced period for Sandimmun Neoral that is approved in EU countries via variation procedure.
Maltese: Il-MAH spjega li l-perjodi ta' kemm idum tajjeb il-prodott mediċinali ma kinux armonizzati u ppropona li jiġi segwit l-aktar approċċ sigur għal Sandimmun (biex jiġi ffissat għal perjodu ta' 36 xahar) u l-aħħar perjodu mnaqqas għal Sandimmun Neoral approvat fil-pajjiżi tal-UE permezz ta' proċedura ta' varjazzjoni.
English: Lastly, based on the fact that ciclosporin is a potent active substance associated with serious safety concerns, the CHMP was of the opinion that the posology section should clearly state that Sandimmun/Sandimmun Neoral is a product to be handled by specialists within the respective therapeutic area; a general wording was agreed and included accordingly in section 4.2.
Maltese: Fl-aħħar nett, abbażi tal-fatt li ciclosporin huwa sustanza attiva qawwija assoċjata ma' tħassib serju dwar is-sigurtà, is-CHMP kien tal-opinjoni li s-sezzjoni tal-pożoloġija għandha tiddikjara b'mod ċar li Sandimmun/Sandimmun Neoral huwa prodott li jrid jiġi mmaniġġjat minn speċjalisti fil-qasam terapewtiku rispettiv; il-kliem ġenerali ġie maqbul u inkluż kif xieraq fis-sezzjoni 4.2.
English: Ciclosporin is also used in a variety of conditions that are known, or may be considered, to be of autoimmune origin (endogenous uveitis, nephrotic syndrome, rheumatoid arthritis, psoriasis and atopic dermatitis).
Maltese: Ciclosporin huwa sustanza immunosoppressiva qawwija li tintuża fi trapjanti ta' organi solidi umani u tal-mudullun biex jiġi evitat rifjut tat-trapjant u f'Mard tal-GVHD. Ciclosporin jintuża wkoll f'varjetà ta' kundizzjonijiet magħrufa, jew li jistgħu jiġu meqjusa, li huma ta' oriġini awtoimmuni (uveite endoġena, sindromu nefrotiku, artrite rewmatika, psorjasi u dermatite atopika).
English: Based on the above the CHMP considers the benefit/risk ratio of Sandimmun to be favourable and the harmonised PI to be approvable.
Maltese: Abbażi ta' dan ta' hawn fuq is-CHMP iqis li l-proporzjon tal-benefiċċju/riskju ta' Sandimmun huwa favorevoli u l-PI armonizzat jista' jiġi approvat.
English: The CHMP therefore agreed with the approach taken by the MAH.
Maltese: Dan il-kliem kien approvat mis-CHMP.
English: The registration of Sandimmun Neoral was based on efficacy and safety data from clinical studies performed with the oil-based formulation (Sandimmun), first registered in Switzerland in December 1982.
Maltese: Irreġistrazzjoni ta' Sandimmun Neoral kienet ibbażata fuq dejta dwar l-effikaċja u s-sigurtà minn studji kliniċi li saru bil-formulazzjoni b'bażi ta' żejt (Sandimmun), irreġistrata l-ewwel darba fl-Isvizzera f'Diċembru 1982.
English: Sandimmun is an oil-based formulation of ciclosporin.
Maltese: Sandimmun huwa formulazzjoni ta' ciclosporin b'bażi ta' żejt.
English: Section 6.3 - Shelf life
Maltese: Sezzjoni 5.3 - Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà
English: The MAH discussed the need of a contraindication of statins for cyclosporin and the need of further contraindications for other medicinal products/herbals.
Maltese: Il-MAH iddiskuta l-ħtieġa ta' kontraindikazzjoni tal-istatins għal cyclosporin u l-ħtieġa ta' kontraindikazzjonijiet ulterjuri għal prodotti mediċinali/erbali oħra.
English: Crysvita contains the active substance burosumab.
Maltese: Crysvita fih is-sustanza attiva burosumab.
English: Crysvita has been given ‘conditional approval'.
Maltese: Crysvita ngħata ‘approvazzjoni kondizzjonali'.
English: The full EPAR for Crysvita can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Side effects with Crysvita (which may affect more than 1 in 10 people) are injection site reactions (such as skin redness, itching, rash, pain and bruising), headache, pain in arms and legs, decreased vitamin D level, rash, toothache, tooth abscess, muscle pain and dizziness.
Maltese: Effetti sekondarji bi Crysvita (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10 persuni) huma reazzjonijiet fil-post tal-injezzjoni (bħal ħmura fil-ġilda, ħakk, raxx, uġigħ u tbenġil), uġigħ ta' ras, uġigħ fl-idejn u s-saqajn, tnaqqis fil-livell ta' vitamina D, raxx, uġigħ fis-snien, infezzjoni tas-snien, uġigħ fil-muskoli u sturdament.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Crysvita can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Crysvita jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The medicine was assessed in one main ongoing study in 52 children aged between 5 and 12 years.
Maltese: Il-mediċina ġiet ivvalutata fi studju wieħed prinċipali kontinwu fi 52 tifel u tifla ta' bejn 5 snin u 12-il sena.
English: This is a summary of the European public assessment report (EPAR) for Crysvita.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Crysvita.
English: Other information about Crysvita
Maltese: Informazzjoni oħra dwar Crysvita
English: The maximum dose is 90 mg every two weeks.
Maltese: Id-doża massima hija ta' 90 mg kull ġimagħtejn.
English: The average score before treatment was 1.9 points in those given Crysvita every 2 weeks, and this fell by 1.0 point after 64 weeks of treatment; in those given the medicine every 4 weeks the baseline score of 1.7 fell by 0.8 point.
Maltese: Il-punteġġ medju qabel il-kura kien 1.9 punti f'dawk mogħtija Crysvita kull ġimagħtejn, u dan naqas b'1.0 punti wara 64 ġimgħa ta' kura; f'dawk li ngħataw ilmediċina kull 4 ġimgħat il-punteġġ bażiku ta' 1.7 naqas b'0.8 punt.
English: Crysvita is a monoclonal antibody (a type of protein) designed to recognise and attach to the FGF23 protein.
Maltese: Crysvita huwa antikorp monoklonali (tip ta' proteina) iddisinjat biex jirrikonoxxi u jingħaqad malproteina FGF23.
English: The main measure of effectiveness was a reduction in the severity of rickets (bone deformities) in the wrist and knee measured on a scale from 0 (normal) to 10 (severe).
Maltese: Il-kejl ewlieni tal-effikaċja kien tnaqqis fis-severità tar-rakitiżmu (deformitajiet tal-għadam) fil-polz u fl-irkoppa mkejla fuq skala minn 0 (normali) sa 10 (severa).