FrancophonIA/ELRC3.0 huggingface dataset:
English: Fertility No fertility studies have been performed with ingenol mebutate.
Maltese: Fertilità Ma saru l-ebda studji dwar il-fertilità b'ingenol mebutate.
English: Application site irritation
Maltese: Irritazzjoni fis-sit talapplikazzjoni
English: SCC in the treatment area was reported in no patients (0 of 184 patients previously treated with ingenol mebutate gel) in the three prospective, observational long term 1 year follow-up studies.
Maltese: SCC fiż-żona tal-kura ma ġiet irrapportata fl-ebda pazjent (0 minn 184 pazjent li fil-passat ġew ikkurati b'ingenol mebutate ġell) fi tliet studji prospettivi, osservazzjonali ta' follow-up fit-tul, li damu sena.
English: Application site ulcer
Maltese: Ulċera fis-sit tal-applikazzjoni
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar riskji).
English: Other possible side effects when treating the trunk and extremities: Common side effects, may affect up to 1 in 10 people:
Maltese: Effetti sekondarji komuni, jistgħu jaffettwaw sa persuna 1 minn kull 10 persuni:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Picato in all subsets of the paediatric population in actinic keratosis (see section 4.2 for information on paediatric use).
Maltese: Billi tirrapporta l effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din ilmediċina.
English: Periorbital oedema
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: At 12 months, the complete clearance rates in these groups were 31% and 19% respectively.
Maltese: Wara 12-il xahar, ir-rati ta' tneħħija kompleta f'dawn il-gruppi kienu ta' 31% u 19% rispettivament.
English: These results did not change the safety profile of Picato (see section 5.1).
Maltese: Dawn ir-riżultati ma bidlux il-profil tas-sigurtà ta' Picato (ara sezzjoni 5.1).
English: Actinic keratosis on the trunk and extremities in adults One tube of Picato 500 mcg/g gel (containing 235 mcg ingenol mebutate) should be applied once daily to the affected area for 2 consecutive days.
Maltese: Stoċċ wieħed ta' Picato 500 µg/g ġell (li fih 235 µg ta' ingenol mebutate) għandu jiġi applikat darba kuljum fuq iż-żona affettwata għal jumejn konsekuttivi.
English: Picato 150 mcg/g gel (n= 92)
Maltese: 150 µg/g ġell (n=92)
English: - Do not get Picato in your eyes.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni.
English: Eye lid oedema
Maltese: Risponsi lokali tal-ġilda
English: Each tube contains 70 mcg of ingenol mebutate in 0.47 g of gel.
Maltese: Kull stoċċ fih 70 µg ta' ingenol mebutate f'0.47 g ta' ġell.
English: METHOD OF ADMINISTRATION
Maltese: MANIFATTUR RESPONSABBLI
English: Interactions with systemically absorbed medicinal products are considered unlikely as Picato is not absorbed systemically.
Maltese: Interazzjonijiet ma' prodotti mediċinali assorbiti b'mod sistemiku huma kkunsidrati li mhumiex mistennija għax Picato ma jiġix assorbit b'mod sistemiku.
English: Following the application of ingenol mebutate, most patients (>95%) experienced one or more local skin response(s).
Maltese: Wara l-applikazzjoni ta' ingenol mebutate, il-biċċa l-kbira tal-pazjenti (>95%) kellhom rispons(i) lokali wieħed jew aktar tal-ġilda.
English: Uncommon Application site paraesthesia Uncommon
Maltese: Eritema fis-sit tal-applikazzjoni Komuni ħafna
English: Median % Reductionc a Complete clearance rate was defined as the proportion of patients with no (zero) clinically visible actinic keratosis lesions in the treatment area.
Maltese: Tnaqqis Medjan f'%ċ a Fejqan komplet ġie definit bħala l-proporzjon ta' pazjenti mingħajr ebda (żero) leżjonijiet ikkawżati minn keratożi aktinika klinikament viżibbli fiż-żona tal-kura.
English: Frequencies have been defined according to the following convention:
Maltese: Il-frekwenzi ġew definiti skont il-konvenzjoni li ġejja:
English: At day 57, patients treated with Picato had higher complete and partial clearance rates than patients treated with vehicle gel (p<0.001).
Maltese: F'jum 57, il-pazjenti kkurati b'Picato kellhom rati ogħla ta' fejqan komplet u parzjali minn pazjenti li ġew ikkurati bil-ġell tal-plaċebo (p<0.
English: Do not use this medicine after the expiry date which is stated on the carton and tube after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna wara EXP u fuq l-istoċċ wara EXP.
English: Application site warmth
Maltese: Wara tal-Id Sider
English: gel 3 tubes
Maltese: ġell 3 stoċċijiet
English: Other side effects: - Swelling of the area around the eye (periorbital oedema) - Swelling (oedema) of your eye lid - Headache
Maltese: Effetti sekondarji oħrajn: - Uġigħ fl-għajnejn - Korriment jew irritazzjoni tal-wiċċ tal-għajn (kornea, konġuntiva) wara esponiment aċċidentali
English: This medicinal product is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Results from two clinical studies on biological effects of ingenol mebutate have shown that topical administration induced epidermal necrosis and a profound inflammatory response in both epidermis and the upper dermis of the treated skin, dominated by infiltrating T cells, neutrophils and macrophages.
Maltese: Ir-riżultati minn żewġ studji kliniċi fuq l-effetti bijoloġiċi ta' ingenol mebutate urew li l-għoti topiku kkaġuna nekrożi epidermali u rispons infjammatorju profond kemm fl-epidermis kif ukoll fin-naħa ta' fuq tad-dermis tal-ġilda kkurata, iddominati minn ċelluli T infiltranti, newtrofili u makrofaġi.
English: Picato 150 micrograms/gram gel is used for actinic keratosis on the face and scalp.
Maltese: Picato 150 mikrogramma/gramma ġell jintuża għal keratożi aktinika fuq il-wiċċ u l-qorriegħa.
English: Picato 500 mcg/g gel is available in a carton containing 2 tubes with 0.47 g of gel each.
Maltese: Picato 500 µg/g ġell hu disponibbli f'kartuna li jkun fiha 2 stoċċijiet b'0.47 g ta' ġell kull wieħed.
English: 29 August 2014
Maltese: 29 ta' Awwissu 2014
English: The MAH(s) should submit the core elements (including outline of DUS, PASS and educational materials) of a risk management plan in EU format.
Maltese: Il-MAH(s) għandu(hom) jippreżenta(w) l-elementi ewlenin (inkluż deskrizzjoni tad-DUS, PASS u materjal edukattiv) ta' pjan għallġestjoni tar-riskju fil-format tal-UE.
English: Annex IV Conditions to the marketing authorisations
Maltese: Anness IV Il-kondizzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq
English: The MAH(s) should submit the next PSUR by:
Maltese: Il-MAH(s) għandu(hom) jissottometti(u) l-PSUR li jmiss sa:
English: The MAH(s) should provide within the risk management plan submission, a protocol for the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Maltese: Il-MAH(s) għandu(hom) jipprovdi(u) fis-sottomissjoni tal-pjan għallġestjoni tar-riskju, protokoll għall-istudju dwar l-użu tal-mediċina sabiex jiġu kkaraterizzati l-prattiċi tal-preskrizzjoni għall-prodotti mediċinali matul użu kliniku tipiku fi gruppi rappreżentattivi ta' dawk li jippreskrivu u biex jiġu vvalutati r-raġunijiet ewlenin għallpreskrizzjoni.
English: Conditions to the marketing authorisations
Maltese: Il-kondizzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq
English: Outline of the education materials within 3 months after EC decision
Maltese: Deskrizzjoni tal-materjal edukattiv fi żmien 3 xhur wara d-deċiżjoni tal-KE
English: The MAH(s) should provide a protocol of a PASS within the risk management plan submission, to evaluate the effectiveness of the risk minimisation activities.
Maltese: Il-MAH(s) għandu(hom) jipprovdi(u) protokoll ta' PASS fissottomissjoni tal-pjan għall-ġestjoni tar-riskju, biex tiġi evalwata leffikaċja tal-attivitajiet tal-minimizzazzjoni tar-riskji.
English: This will be included in the risk management plan, highlighting the risks and warnings of thromboembolism (by e.g. a checklist, to be implemented at national level).
Maltese: Dan se jiġi inkluż fil-pjan għall-ġestjoni tar-riskju, u jenfasizza r-riskji u ttwissijiet ta' tromboemboliżmu (pereżempju permezz ta' checklist, li għandu jiġi implimentat fuq livell nazzjonali).
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-awtoritajiet nazzjonali kompetenti tal-Istat(i) Membru(i) jew l-Istat(i) Membru(i) ta' referenza jekk applikabbli, għandhom jiżguraw li l-kondizzjonijiet li ġejjin jiġu sodisfatti mill-MAH(s):
English: The MAH(s) should provide within the risk management plan Educational material for prescribers and patients.
Maltese: Il-MAH(s) għandu(hom) jipprovdi(u) fil-pjan għall-ġestjoni tar-riskju materjal edukattiv għal min jippreskrivi u għall-pazjenti.
English: dinutuximab beta
Maltese: Qarziba dinutuximab beta
English: The full EPAR for Qarziba 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: The summary of the opinion of the Committee for Orphan Medicinal Products for Qarziba 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 Qarziba jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The medicine contains the active substance dinutuximab beta.
Maltese: Il-mediċina fiha s-sustanza attiva dinutuximab beta.
English: The name of the product was changed to Dinutuximab beta EUSA on 4 August 2017 and to Qarziba on 27 November 2017.
Maltese: L-isem tal-prodott inbidel għal Dinutuximab beta EUSA fl-4 ta' Awwissu 2017 u għal Qarziba fis-27 ta' Novembru 2017.
English: This summary was last updated on 12-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'12-2017.
English: Each course of treatment with the medicine is given for 5 or 10 days every 35 days.
Maltese: Kull kors ta' kura bil-mediċina jingħata għal 5 jew 10 ijiem kull 35 jum.
English: Of the patients who had some sign of neuroblastoma, 63% of those given interleukin-2 were still alive 3 years after treatment compared with 54% of patients who did not receive interleukin-2.
Maltese: Mill-pazjenti li kellhom xi sinjal ta' newroblastoma, 63 % ta' dawk li ngħataw interleukin-2 kienu għadhom ħajjin 3 snin wara l-kura meta mqabbel ma' 54 % tal-pazjenti li ma rċivewx interleukin-2.
English: Because the number of patients with neuroblastoma is low, the disease is considered ‘rare', and Qarziba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 November 2012.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn newroblastoma huwa baxx, il-marda hija kkunsidrata ‘rari', u Qarziba ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit8 ta' Novembru 2012.
English: This is a summary of the European public assessment report (EPAR) for Qarziba.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta᾿ valutazzjoni (EPAR) għal Qarziba.
English: (allergy), vomiting, diarrhoea, capillary leak syndrome (leakage of fluid from blood vessels that can cause swelling and a drop in blood pressure) and hypotension (low blood pressure).
Maltese: Effetti sekondarji oħrajn (li jistgħu jaffettwaw aktar minn 3 minn kull 10) huma sensittività eċċessiva (allerġija), rimettar, dijarea, sindrome ta᾽ tnixxija kapillari (tnixxija ta' fluwidu minn vini tad-demm żgħar li tista' tikkawża nefħa u tnaqqis rapidu fil-pressjoni tad-demm) u pressjoni baxxa (pressjoni tad-demm baxxa).
English: Why is Qarziba approved?
Maltese: Għaliex ġie approvat Qarziba?
English: In a third study, 370 children with high-risk neuroblastoma that had improved after other treatments were given Qarziba and isotretinoin with or without interleukin-2.
Maltese: Fit-tielet studju, 370 wild b'riskju għoli ta' newroblastoma li tjiebu wara kuri oħrajn ingħataw Qarziba u isotretinoin bi jew mingħajr interleukin-2.
English: Two studies analysed data from 88 children and adults with neuroblastoma that had not improved with other cancer treatments or had come back.
Maltese: Żewġ studji analizzaw data minn 88 wild u adult bin-newroblastoma li ma tjibux b'kuri oħrajn tal-kanċer jew li rritornat.
English: Qarziba is given as an infusion (drip) into a vein.
Maltese: Qarziba jingħata bħala infużjoni (dripp) ġol-vina.
English: Qarziba is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a structure called GD2 that is present in high amounts on the surface of neuroblastoma cells, but not normal cells.
Maltese: Qarziba huwa antikorp monoklonali (tip ta' proteina) li tfassal biex jirrikonoxxi u jeħel ma' struttura msejħa GD2 li hija preżenti f'ammonti għoljin fil-wiċċ taċ-ċelluli tan-newroblastoma, iżda mhux fiċċelluli normali.
English: Of the patients with neuroblastoma that had come back, 42% and 69% were still alive 2 years after treatment.
Maltese: Mill-pazjenti b'newroblastoma li rritornat, 42 % u 69 % kienu għadhom ħajjin sentejn wara l-kura.
English: What are the risks associated with Qarziba?
Maltese: X'inhuma r-riskji assoċjati ma' Qarziba?
English: Of the patients who had no sign of neuroblastoma, 71% were still alive 3 years after treatment and the results were similar whether the treatment included interleukin-2 or not.
Maltese: Mill-pazjenti li ma kellhom lebda sinjal ta' newroblastoma, 71 % kienu għadhom ħajjin wara 3 snin ta' kura u r-riżultati kienu simili irrilevanti mill-fatt jekk il-kura kinitx tinkludi interleukin-2 jew le.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dinutuximab beta Apeiron on 8 May 2017.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Dinutuximab beta Apeiron fit-8 ta' Mejju 2017.
English: Taken together, data on outcomes with Qarziba show that the medicine is effective.
Maltese: Meta tittieħed flimkien, id-data dwar ir-riżultati b'Qarziba turi li l-mediċina hija effettiva.
English: As dinutuximab is a recommended treatment for high-risk neuroblastoma, it would not be ethical to carry out a trial in which some patients were given placebo (a dummy treatment).
Maltese: Peress li dinutuximab huwa kura rakkomandata għal newroblastoma ta' riskju għoli, mhuwiex etiku li titwettaq prova li fiha xi pazjenti jingħataw il-plaċebo (kura finta).
English: Other information about Qarziba
Maltese: Kif jintuża Qarziba?
English: What information is still awaited for Qarziba?
Maltese: Liema informazzjoni għadha mistennija għal Qarziba?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted the lack of treatment options to prevent high-risk neuroblastoma from coming back.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) innota n-nuqqas ta' għażliet ta' kura għall-prevenzjoni ta' newroblastoma ta' riskju għoli milli tirritorna.
English: Therefore the CHMP decided that Qarziba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għaldaqstant, is-CHMP iddeċieda li l-benefiċċji ta' Qarziba huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: In these studies, 70% and 78% of the patients whose neuroblastoma had not improved with other treatments were still alive 2 years after treatment.
Maltese: F'dawn l-istudji, 70 % u 78 % tal-pazjenti li n-newroblastoma tagħhom ma tjibitx b'kuri oħrajn kienu għadhom ħajjin sentejn wara l-kura.
English: Although treatment with Qarziba can cause serious side effects, the safety of the medicine is considered acceptable.
Maltese: Għalkemm il-kura b'Qarziba tista' tikkawża effetti sekondarji serji, is-sigurtà tal-mediċina hija kkunsidrata aċċettabbli.
English: Previously known as Dinutuximab beta Apeiron and Dinutuximab beta EUSA.
Maltese: L-EPAR sħiħ għal Qarziba jinstab fis-sit elettroniku tal-Aġenzija:
English: This is because it has not been possible to obtain complete information about Qarziba for ethical reasons.
Maltese: Dan minħabba li ma kienx possibbli li tinkiseb informazzjoni kompluta dwar Qarziba minħabba raġunijiet etiċi.
English: Patients were treated with Qarziba plus interleukin-2 and another medicine called isotretinoin.
Maltese: Id-doża rakkomandata tiddependi fuq il-piż u t-tul tal-pazjent.
English: Qarziba is a cancer medicine used to treat neuroblastoma, a cancer of nerve cells, in patients over 1 year of age.
Maltese: Qarziba huwa mediċina kontra l-kanċer li jintuża biex jikkura n-newroblastoma, kanċer fiċ-ċelluli tannervituri, f'pazjenti akbar minn sena.
English: Since Qarziba has been approved under exceptional circumstances, the company that markets Qarziba will monitor the safety of the medicine using a patient registry and provide yearly updates.
Maltese: Minħabba li Qarziba ġie approvat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed Qarziba fissuq se timmonitorja s-sigurtà tal-mediċina bl-użu ta' reġistru tal-pazjenti u se tipprovdi aġġornamenti fis-sena.
English: For the full list of all side effects and restrictions with Qarziba, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Qarziba, ara l-fuljett ta' tagħrif.
English: The most common side effects with Qarziba (which may affect more than 7 in 10 people) are pyrexia (fever) and pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Qarziba (li jistgħu jaffettwaw aktar minn 7 minn kull 10) huma deni u uġigħ.
English: It is used in 2 groups of patients who have high-risk neuroblastoma (which has a high chance of coming back):
Maltese: Dan jintuża f'2 gruppi ta' pazjenti li għandhom riskju għoli ta' newroblastoma (li għandha probabbiltà għolja li tirritorna):
English: It must be given in hospital by a doctor or nurse who can manage severe allergic reactions and who has full resuscitation services immediately available if needed.
Maltese: Din għandha tingħata fi sptar minn tabib jew infermier li jista' jimmaniġġja reazzjonijiet allerġiċi severi u li jkollu servizzi ta' risuxxitazzjoni sħiħa disponibbli immedjatament jekk ikunu meħtieġa.
English: Qarziba is used together with another medicine called interleukin-2 (aldesleukin) in some cases where previous treatments have not worked well enough.
Maltese: Qarziba jintuża flimkien ma' mediċina oħra msejħa interleukin-2 (aldesleukin) f'xi każijiet meta kuri preċedenti ma jkunux ħadmu tajjeb biżżejjed.
English: Treatment with Qarziba should not be started unless the patient has satisfactory results in certain blood tests of liver, lung, kidney and bone marrow function.
Maltese: Il-kura b'Qarziba m'għandhiex tinbeda sakemm il-pazjent ikollu riżultati sodisfaċenti f'ċerti testijiet taddemm tal-fwied, tal-pulmun, tal-kliewi u tal-funzjoni tal-mudullun.
English: Conditions to be fulfilled by the MAH:
Maltese: Kundizzjonijiet li għandhom jiġu sodisfati mill-MAH:
English: The MAH shall submit to the national competent authorities, at the time of the next Periodic Safety Update Report (PSUR), a risk management plan (RMP) for all affected products using the agreed consolidated RMP, version 2.0 of 21 September 2011, which describes the products' safety concerns (cloudy effluent/aseptic peritonitis with peritoneal dialysis solutions and endotoxin induced systemic inflammatory response with haemodialysis solutions) and their risk minimisation which includes a direct healthcare professional communication and quality activities.
Maltese: Il-MAH għandu jissottometti lill-awtoritajiet nazzjonali kompetenti, fiż-żmien tar-Rapport Perjodiku li jmiss dwar l-Aġġornament tas-Sigurtà (PSUR), pjan ta' ġestjoni tar-riskju (RMP) għall-prodotti kollha affettwati permezz tal-RMP ikkonsolidat miftiehem, verżjoni 2.0 tal-21 ta' Settembru 2011, li jiddeskrivi t-tħassib dwar is-sigurtà tal-prodotti (likwidu mdardar/peritonite asettika fil-każ tas-soluzzjonijiet għad-dijaliżi tal-peritonew u reazzjoni infjammatorja sistemika kkawżata mill-endotossini fil-każ tas-soluzzjonijiet għad-dijaliżi tad-demm) u t-tnaqqis tarriskju tagħhom li jinkludi komunikazzjoni diretta mal-professjonisti tal-kura tas-saħħa u attivitajiet ta' kwalità.
English: The MAH shall draw up global corrective and preventive actions (CAPA) and use them to prevent endotoxin contamination at other sites producing dialysis solutions.
Maltese: Il-MAH għandu jfassal azzjonijiet globali korrettivi u preventivi (CAPA) u jużahom għallprevenzjoni ta' kontaminazzjoni minn endotossini f'siti oħrajn li jipproduċu s-soluzzjonijiet għad-dijaliżi.
English: A pharmacovigilance inspection shall be carried out by the competent authority by end of September 2012.
Maltese: Għandha ssir spezzjoni tal-farmakoviġilanza mill-awtorità kompetenti sal-aħħar ta' Settembru 2012.
English: The MAH shall perform a 12 month monitoring after site qualification by the supervisory authority (IMB) in Castlebar.
Maltese: Il-MAH għandu jwettaq monitoraġġ fuq 12-il xahar wara l-kwalifikazzjoni tas-sit mill-awtorità superviżorja (IMB) f'Castlebar.
English: Annex III Conditions of the marketing authorisations
Maltese: Anness III Kondizzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq
English: The MAH shall perform epidemiological studies consisting of a clinical audit that will collect data on the number of peritonitis events in the EU in 2010 and 2011 and an observational study to assess the nature of peritonitis and non-peritonitis cases (including fatal outcomes) and their outcome, in accordance with the milestones for evaluation and reporting described in the consolidated RMP.
Maltese: Il-MAH għandu jwettaq studji epidemjoloġiċi li jikkonsistu f'verifika klinika li tiġbor dejta dwar lgħadd ta' każijiet ta' peritonite fl-UE fl-2010 u fl-2011 u studju ta' osservazzjoni sabiex jevalwa n-natura tal-każijiet ta' peritonite u mhux ta' peritonite (inklużi eżiti fatali) u l-eżitu tagħhom, f'konformità mal-miri miftiehma għall-evalwazzjoni u r-rappurtar kif deskritt fl-RMP ikkonsolidat.
English: This RMP shall follow the EU RMP template (as referenced in Volume 9a of The Rules Governing Medicinal Products in the European Union) and shall include the measures to assess the effectiveness of the risk minimisation in the agreed consolidated RMP.
Maltese: Dan l-RMP għandu jsegwi l-mudell ta' RMP tal-UE (kif imsemmi fil-Volum 9a tar-Regoli li jirregolaw il-Prodotti Mediċinali fl-Unjoni Ewropea)u għandu jinkludi l-miżuri għall-evalwazzjoni tal-effikaċja tat-tnaqqis tar-riskju fl-RMP ikkonsolidat miftiehem.
English: Within 90 days of the finalisation of said monitoring period, a change management plan shall be submitted to the national competent authorities.
Maltese: Fi żmien 90 jum mill-finalizzazzjoni tal-perjodu ta' monitoraġġ imsemmi, għandu jiġi sottomess pjan ta' ġestjoni ta' bidla lill-awtoritajiet kompetenti nazzjonali.
English: The MAH shall update the marketing authorisations of the affected dialysis solutions with the improved microbiological analytical methodologies and inclusion of new sites for increasing the diversity of supply in accordance with the change management plan and its timelines.
Maltese: Il-MAH għandu jaġġorna l-awtorizzazzjonijiet għat-tqegħid fis-suq tas-soluzzjonijiet għaddijaliżi affettwati bil-metodoloġiji mikrobijoloġiċi analitiċi mtejba u jinkludi s-siti l-ġodda għażżieda fid-diversità tal-provvista skont il-pjan ta' ġestjoni tal-bidla u l-iskadenzi tiegħu.