FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Maltese: Minħabba dan ir-riskju potenzjali ta' komplikazzjonijiet trombotiċi, għandu jkun hemm sorveljanza klinika għal sinjali bikrija ta' koagulopatija trombotika u li tikkonsma, permezz ta' testijiet bioloġiċi adattati, meta jingħata lill-pazjenti b'mard tal-fwied, lil pazjenti wara l-operazzjonijiet, lit-trabi tattwelid, jew lil pazjenti b'riskju ta' mard trombotiku jew DIC.
English: Nonafact can be administered to prevent and treat bleeding in patients suffering from haemophilia B (a congenital lack of active factor IX).
Maltese: Nonafact jista' jingħata sabiex jipprevjeni u jikkura l- fsada (ħruġ ta' demm) f'pazjenti li jbatu millemofilja B (nuqqas konġenitu ta' forma attiva ta' fattur IX).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) f'kull doża, jiġifieri għandu jitqies li hu essenzjalment ‘mingħajr sodju'.
English: For long-term prevention of bleeding in individuals with severe haemophilia B, the usual doses of 20 to 40 IU of factor IX per kilogram body weight should be given at intervals of 3 to 4 days.
Maltese: Għall-prevenzjoni fit-tul ta' fsada f'individwi b'emofilja B serja, għandhom jingħataw id-dożi tassoltu ta' 20 sa 40 IU ta' fattur IX għal kull kilogramma ta' piż tal-ġisem f'intervalli ta' bejn 3 u 4 ijiem.
English: For reconstitution of Nonafact.
Maltese: Għar-rikostituzzjoni ta' Nonafact.
English: Nonafact consists of a carton containing:
Maltese: Nonafact jikkonsisti f'pakkett tal-kartun li fih:
English: Posology and method of administration
Maltese: ANNESS I KARATTERISTIĊI
English: The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
Maltese: In-numru ta' unitajiet ta' fattur IX mogħtija huwa espress f'Unitajiet Internazzjonali (IU), li huma relatati ma' l-Istandard Internazzjonali kurrenti standard tal-WHO ta' prodotti ta' fattur IX.
English: VIAL OF POWDER 500 IU VIAL OF POWDER 1000 IU
Maltese: IU KUNJETT TA' TRAB TA' 1000
English: 60-100 Repeat infusion every 8 to 24 hours until threat is resolved.
Maltese: Irrepeti l-infużjoni kull 8 sa 24 siegħa sakemm ir-riskju jiġi kontrollat.
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Maltese: L-attivita' tal-fattur IX fil-plażma hija espressa jew bħala peċentwali (relattiva għall-plażma umana normali) jew f'Unitajiet Internazzjonali (relattiva għall-Istandard Internazzjonali għal fattur IX fil-plażma).
English: It is recommended that the rate of administration should not exceed 2 ml/min.
Maltese: Huwa rrakkmandat li r-rata tat-teħid ma tkunx aktar minn 2ml kull minuta.
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Maltese: Kura u profilassi ta' fsada (ħruġ ta' demm) f'pazjenti li jbatu mill-emofilja B (defiċjenza konġenitali tal-fattur IX)
English: One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of human plasma.
Maltese: Unità Internazzjonali waħda(IU) ta' l-attività ta' fattur IX hija ekwivalenti għal dik il-kwantità ta' fattur IX f'ml wieħed ta' plażma umana.
English: 1 vial of powder for solution for injection 1 vial water for injections 5 ml 1 vial water for injections 10 ml
Maltese: Kunjett ta' trab għal soluzzjoni għall-injezzjoni Kunjett ta' ilma għall-injezzjonijiet 5 ml Kunjett ta' ilma għall-injezzjonijiet 10 ml
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Maltese: Jekk tagħmir ta' aċċess venuż ċentrali (CVAD, central venous access device) ikun meħtieġ, ir-riskju ta' kumplikazzjonijiet relatati mas-CVAD li jinkludu infezzjonijiet lokali, batteremija u trombożi fissit tal-kateter, għandhom jiġu kkunsidrati.
English: Because of the risk of allergic reactions with factor IX products, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Maltese: Minħabba r-riskju ta' reazzjonijiet allerġiċi bi prodotti ta' fattur IX, l-għotjiet inizjali ta' fattur IX għandhom, skont il-ġudizzju tat-tabib kuranti, isiru taħt osservazzjoni medika fejn kura medika xierqa għal reazzjonijiet allerġiċi tkun tista' tiġi pprovduta.
English: No interactions of human coagulation factor IX products with other medicinal products have been reported.
Maltese: Mhux magħruf li hemm interazjoni ta' prodotti li fihom fattur IX tal-koagulazzjoni umana ma' prodotti mediċinali oħra ġew irrappurtati.
English: Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Maltese: Hija dovuta għal livelli mnaqqsa tal-fattur IX u tirriżulta fi fsada qawwija fil-ġogi, fil-muskoli jew fl-organi interni, b'effett spontanju jew bħala riżultat ta' trawma aċċidentali jew kirurġika.
English: In rare cases, Nonafact can give rise to a severe allergic reaction (anaphylactic shock).
Maltese: F'każijiet rari, Nonafact jista' jikkawża reazzjoni allerġika serja (xokk anafilattiku).
English: INFORMATION IN BRAIILE 17.
Maltese: INFORMAZZJONI BIL-BRAILLE
English: The following information is intended for healthcare professionals only:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq u l-Manifattur:
English: • A vial water for injections containing 5 ml or 10 ml
Maltese: • Kunjett ta' ilma għall-injezzjonijiet li fih 5 ml jew 10 ml
English: - The other ingredients are sodium chloride, sucrose, histidine and water for injections.
Maltese: - Is-sustanzi l-oħra huma l-kloru tas-sodju, s-sukrożju, histidine u ilma għall-injezzjonijiet.
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Maltese: F'pazjenti b'fatturi ta' riskju kardjovaskulari eżistenti, terapija ta' sostituzzjoni b'FIX tista' żżid irriskju kardjovaskulari.
English: Reconstitute with 10 ml of water for injections.
Maltese: Irrikostitwixxi b'10 ml ta' ilma għall-injezzjonijiet.
English: BOX VIAL OF POWDER 500 IU BOX VIAL OF POWDER 1000 IU
Maltese: KAXXA BI KUNJETT TA' TRAB TA' 500
English: More extensive haemarthrosis, muscle bleeding or haematoma
Maltese: Emartrożi aktar estensiva, fsada mill-muskolu jew ematoma
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 1.1 % of normal activity.
Maltese: Il-kalkolu tad-doża ta' fattur IX, meħtieġa huwa bbażat fuq is-sejba empiriku li Unità Internazzjonali (IU) waħda ta' fattur IX għal kull kilo ta' piż tal-ġisem tgħolli l-attività ta' fattur IX fil-plażma b'1.1% ta' l-attività normali.
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Maltese: Pazjenti b'emofilja B jistgħu jiżviluppaw anti-korpi newtralizzanti (inibituri) għall-fattur IX.
English: Nonafact contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Maltese: Nonafact fih inqas minn 1 mmol sodju (23 mg) f'kull doża, jiġifieri għandu jitqies li hu essenzjalment ‘mingħajr sodju'.
English: Reconstitute with 5 ml of water for injections.
Maltese: Irrikostitwixxi b'5 ml ta' ilma għall-injezzjonijiet.
English: Minor surgery including tooth extraction
Maltese: Kirurġija minuri inkluża l-qlugħ tas-snien
English: 1000 IU human coagulation factor IX (100 IU/ml after reconstitution).
Maltese: IU ta' fattur IX ta' koagulazzjoni umana (100 IU/ml wara r-rikostituzzjoni). 1000
English: Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu jitpoġġew fis-suq.
English: By replacement therapy the plasma level of factor IX is increased, thereby enabling a temporary correction of the factor IX deficiency and correction of the bleeding tendencies.
Maltese: Permezz ta' terapija ta' sostituzzjoni il-livelli ta' fattur IX fil-plażma jiżdied, u b'hekk ikun hemm korrezzjoni temporanja tan-nuqqas ta' fattur IX u tat-tendenza ta' fsada.
English: 30-60 Every 24 hours, at least 1 day, until healing is achieved.
Maltese: Kull 24 siegħa, mill-inqas ġurnata waħda, sakemm ikun hemm fejqan.
English: How to store Nonafact
Maltese: Jekk tinsa tuża Nonafact
English: The other (serious and non-serious) adverse reactions were received by spontaneous reporting.
Maltese: Ir-reazzjonijiet avversi l-oħrajn (serji u mhux serji) ġew riċevuti minn rappurtaġġ spontanju.
English: Individuals with haemophilia B who receive factor IX preparations, should be monitored for the development of neutralising antibodies against factor IX (inhibitors) (see Possible side effects).
Maltese: Individwi li jbatu minn emofilja B li qed jirċievu sustanzi ta' fattur IX, għandhom ikunu monitorjati għall-iżvilupp ta' anti-korpi newtralizzanti kontra l-fattur IX (inibituri) (ara Effetti oħra li jistgħu jinħassu).
English: Early haemarthrosis, muscle bleeding or oral bleeding
Maltese: Emartrożi bikrija, fsada millmuskolu jew orali
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Maltese: It-tabella li ġejja tista' tintuża bħala gwida għal dożi f'episodji ta' fsada u kirurġija:
English: Bleeding
Maltese: Sentejn
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TALUŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Nonafact 100 IU/ml powder for solution for injection Human coagulation factor IX for intravenous use
Maltese: Nonafact 100 IU/ml trab għal soluzzjoni għall-injezzjoni.
English: NAME OF THE MEDICINAL PRODUCT Nonafact 100 IU/ml powder and solvent for solution for injection.
Maltese: Nonafact 100 IU/ml trab u solvent għal soluzzjoni għall-injezzjoni.
English: Life threatening haemorrhages
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: Not known
Maltese: {numru}
English: 30-60 Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved.
Maltese: Irrepeti l-infużjoni kull 24 siegħa għal 3-4 ijiem jew aktar sakemm luġigħ u d-disabilità akuta jgħaddu.
English: The dose and duration of substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Maltese: Id-doża u t-tul tat-terapija ta' sostituzzjoni jiddependu mis-severità tad-defiċjenza tal-fattur IX, fuq ilpost u l-gravità ta' ħruġ ta' demm u fuq il-kondizzjoni klinika tal-pazjent.
English: The use of Nonafact may also produce an increase in body temperature in rare cases.
Maltese: L-użu ta' Nonafact jista' wkoll jipproduċi żieda fit-temperatura tal-ġisem f'każijiet rari.
English: What Nonafact looks like and contents of the pack
Maltese: Id-dehra ta' Nonafact u l-kontenut tal-pakkett
English: The specific activity of Nonafact is approximately 200 IU/mg protein.
Maltese: L-attività speċifika ta' Nonafact hija ta' madwar 200
English: No symptoms of overdose with human coagulation factor IX have been reported.
Maltese: IU ta' fattur IX tal-koagulazzjoni umana.
English: Major surgery
Maltese: Kirurġija maġġuri
English: 500 IU human coagulation factor IX (100 IU/ml after reconstitution).
Maltese: IU (100 IU/ml wara r-rikostituzzjoni).
English: Swirl the vial gently to completely dissolve the powder.
Maltese: Twissijiet speċjali u prekawzjonijiet għall-użu
English: Anaphylactic reaction
Maltese: Reazzjonijiet allerġiċi
English: (pre- and postoperative)
Maltese: (IU/dl)
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Maltese: Kien hemm rapporti fil-letteratura li wrew korrelazzjoni bejn l-okkorrenza ta' inibitur ta' fattur IX u reazzjonijiet allerġiċi.
English: Do not shake!
Maltese: IU KAXXA BI
English: 10 vials
Maltese: 10 kunjetti
English: 1 vial
Maltese: Daqs talpakkett kunjett 1
English: Two initial opinions were issued.
Maltese: Inħarġu żewġ opinjonijiet inizjali.
English: Enhancements of the affected line were proposed in order to prevent the occurrence of future biofilm/microbial contamination problems.
Maltese: Ġie propost titjib fil-linja affettwata sabiex jiġu evitati problemi ta' kontaminazzjoni minn biofilm/mikrobi fil-futur.
English: Products manufactured at the affected lines in Castlebar included peritoneal dialysis (PD) solutions Dianeal, Extraneal and Nutrineal; and Monosol and 0.9% sodium chloride for haemodialysis.
Maltese: Il-prodotti mmanifatturati fil-linji affettwati f'Castlebar kienu jinkludu s-soluzzjonijiet għaddijaliżi peritoneali (PD) Dianeal, Extraneal u Nutrineal; u Monosol u 0.9 % klorur tas-sodju għallemodijaliżi.
English: Although protein/biofilm were not found upon dismantling the line, Gram positive and Gram negative microorganisms were identified.
Maltese: Għalkemm ma nstabitx proteina/biofilm meta żżarmat il-linja, ġew identifikati mikroorganiżmi Gram pożittivi u Gram negattivi.
English: In addition to the programme of quality improvement, future assured supply steps were developed.
Maltese: Minbarra l-programm ta' titjib fil-kwalità, ġew żviluppati passi futuri ta' provvista assigurati.
English: The CHMP agreed with the proposed studies.
Maltese: Is-CHMP qabel malistudji proposti.
English: Additional risk minimisation activities focus on reporting of batch numbers, communication via a direct healthcare professional communication and an adverse event questionnaire in addition to quality risk minimisation activities.
Maltese: Attivitajiet oħrajn ta' tnaqqis tar-riskju jiffukaw fuq ir-rappurtar tan-numri tal-lottijiet, ilkomunikazzjoni permezz ta' komunikazzjoni professjonali diretta tal-kura tas-saħħa u kwestjonarju dwar l-avvenimenti avversi minbarra attivitajiet ta' tnaqqis tar-riskju tal-kwalità.
English: • The Committee agreed with the change management plan for development of the global corrective and preventive actions (CAPA) at Castlebar.
Maltese: • Il-Kumitat qabel mal-pjan ta' ġestjoni tal-bidla għall-iżvilupp ta' azzjonijiet globali korrettivi u preventivi (CAPA) f'Castlebar.
English: These dialysis solutions were thus imported from Canada, Singapore, Turkey and USA.
Maltese: Dawn is-soluzzjonijiet għad-dijaliżi għalhekk ġew impurtati mill-Kanada, Singapor, itTurkija u l-Istati Uniti tal-Amerika.
English: In view of severe supply limitations for Dianeal, Extraneal and Nutrineal and the risk of switching patients to alternative PD solutions or therapies, the CHMP considered that the use of comparable products produced by Baxter at alternative manufacturing sites outside the EEA (European Economic Area) should be prioritised, as these products were assessed to be therapeutically equivalent to the EU products, and there was sufficient reassurance regarding their quality.
Maltese: Minħabba l-limitazzjonijiet severi ta' provvista għal Dianeal, Extraneal u Nutrineal u r-riskju tal-qlib tal-pazjenti għal soluzzjonijiet jew terapiji alternattivi għall-PD, is-CHMP qies li l-użu ta' prodotti komparabbli magħmula minn Baxter f'siti alternattivi tal-manifattura barra miż-ŻEE (Żona Ekonomika Ewropea) għandu jingħata prijorità, peress li dawn il-prodotti kienu vvalutati bħala terapewtikament ekwivalenti għall-prodotti tal-UE, u kien hemm biżżejjed assigurazzjoni rigward ilkwalità tagħhom.
English: Monosol and 0.9% sodium chloride for haemodialysis solutions were promptly recalled from the market as alternatives were available.
Maltese: Il-monosol u 0.9 % klorur tas-sodju għas-soluzzjonijiet emodijaliżi tneħħew mis-suq minnufih minħabba li kien hemm alternattivi disponibbli.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for dialysis solutions from Baxter group of companies and associated companies produced at Castlebar (see annex I).
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE, għas-soluzzjonijiet għad-dijaliżi mill-grupp ta' kumpaniji Baxter u kumpaniji assoċjati prodotti f'Castlebar (ara Anness I).
English: Care should be taken to ensure consistency.
Maltese: Għandha tingħata attenzjoni għall-konsistenza.
English: Overall summary of the scientific evaluation of dialysis solutions from Baxter group of companies and associated companies produced at Castlebar (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika tas-soluzzjonijiet għad-dijaliżi mill-grupp ta' kumpaniji Baxter u kumpaniji assoċjati prodotti f'Castlebar (ara Anness I)
English: This heightened pharmacovigilance was applied to products from alternative sites supplying Europe.
Maltese: Din iż-żieda fil-farmakoviġilanza ġiet applikata għal prodotti minn siti alternattivi li jfornu lill-Ewropa.
English: For completeness, the CHMP considered that a pharmacovigilance inspection should be carried out.
Maltese: Għall-kompletezza, is-CHMP ikkunsidra li għandha ssir spezzjoni tal-farmakoviġilanza.
English: • The Committee considers that critical enhancements have been introduced, including the re-design of the affected lines, introduction of modern rapid microbial methods on site to raw materials, excipients and finished product, and a more sensitive method for endotoxin testing, with tightened limit of detection for both finished product and excipients.
Maltese: • Il-Kumitat jikkunsidra li ġie introdott tibdil kritiku, inkluż id-disinn mill-ġdid tal-linji affettwati, lintroduzzjoni ta' metodi moderni u rapidi kontra l-mikrobi fil-materja prima fuq is-sit, fl-eċċipjenti u fil-prodott lest, u metodu aktar sensittiv ta' ttestjar għall-endotossini, b'limitu ta' detezzjoni strett kemm għall-prodott lest kif ukoll għall-eċċipjenti.
English: • The Committee considers that the future supply programme submitted by the MAH adequate.
Maltese: • Il-Kumitat jikkunsidra li l-programm ta' provvista futura sottomess mill-MAH huwa adegwat.
English: Further to the replacement of the product from Castlebar, mostly completed in April 2011, a decline in the number of aseptic peritonitis cases reported was observed.
Maltese: Wara s-sostituzzjoni talprodott minn Castlebar, li l-parti l-kbira tagħha tlestiet f'April 2011, ġie osservat tnaqqis fl-għadd ta' każijiet ta' peritonite asettika rrappurtati.
English: This should allow early detection of low levels of endotoxin and trend analysis which should provide an early safety warning.
Maltese: Dan għandu jippermetti detezzjoni bikrija ta' livelli baxxi ta' endotossina u analiżi tat-tendenza li għandha tipprovdi twissija bikrija ta' sigurtà.
English: The first on the inclusion of the sites located in Canada, Poland and Turkey as additional manufacturing sites to the marketing authorisations of the respective peritoneal dialysis solutions was issued by the Committee in April 2011, and the corresponding decision from the Commission was issued on 12 May 2011.
Maltese: L-ewwel waħda dwar l-inklużjoni tas-siti li jinsabu fil-Kanada, ilPolonja u t-Turkija bħala siti addizzjonali ta' manifattura mal-awtorizzazzjonijiet għat-tqegħid fis-suq tas-soluzzjonijiet rispettivi għad-dijaliżi peritoneali nħarġet mill-Kumitat f'April 2011, u d-deċiżjoni korrispondenti tal-Kummissjoni nħarġet fit-12 ta' Mejju 2011.
English: Overall, a combination of factors may have played a role in the findings, such as inadequately designed equipment, mechanical failure of equipment (cracks having been detected in some tanks used in the affected lines), methods of microbial monitoring not applied routinely and not state of the art, including outdated methods for monitoring endotoxins, and an inadequate cleaning and sanitisation regimen.
Maltese: B'mod ġenerali, taħlita ta' diversi fatturi setgħu kellhom rwol fis-sejbiet, bħal tagħmir iddisinjat b'mod inadegwat, ħsara mekkanika fit-tagħmir (instabu xquq f'xi wħud mittankijiet użati fil-linji affettwati), metodi ta' monitoraġġ għall-mikrobi mhux applikati b'mod regolari u mhux avvanzati, inklużi metodi antikwati għall-monitoraġġ tal-endotossini, u sistema inadegwata ta' tindif u ta' ħarsien tas-saħħa.
English: During the article 31, several measures were put in place in order to monitor the risk of developing aseptic peritonitis, identified as the primary risk following the use of dialysis solutions manufactured at the affected manufacturing lines in Castlebar.
Maltese: Matul l-Artikolu 31, ġew stabbiliti diversi miżuri sabiex ikun issorveljat ir-riskju ta' żvilupp ta' peritonite asettika, identifikata bħala r-riskju prinċipali wara l-użu ta' soluzzjonijiet għad-dijaliżi mmanifatturati fil-linji ta' manifattura affettwati f'Castlebar.
English: • The Committee requires the MAH to perform the epidemiological studies agreed, the clinical audit and observational study, and other measures as detailed in the risk management plan.
Maltese: • Il-Kumitat jeżiġi li l-MAH iwettaq l-istudji epidemjoloġiċi miftiehma, il-verifika klinika u l-istudju ta' osservazzjoni, u miżuri oħrajn kif deskritt fil-pjan ta' ġestjoni tar-riskju.
English: The Singaporean manufacturing plant was only used once and no longer considered as an alternative.
Maltese: L-impjant tal-manifattura Singaporjan intuża darba biss u m'għadux meqjus bħala alternattiva.
English: An article 31 referral procedure of Directive 2001/83/EC was initiated by the European Commission (EC) following receipt of information from Baxter indicating that their manufacturing problem related to outof-specifications results for endotoxins in dialysis solutions produced at Castlebar was not resolved and the root cause had not been identified.
Maltese: Il-Kummissjoni Ewropea (KE) bdiet proċedura ta' riferiment skont l-Artikolu 31 tadDirettiva 2001/83/KE wara li rċeviet tagħrif mingħand Baxter li kien jindika li l-problema ta' manifattura tagħhom relatata mar-riżultati mhux fl-ispeċifikazzjonijiet għal endotossini fissoluzzjonijiet għad-dijaliżi prodotti f'Castlebar ma kinitx solvuta u li l-kawża ewlenija ma kinitx ġiet identifikata.
English: As an additional measure, a consolidated risk management plan (RMP) specific for the re-launch of dialysis solutions manufactured at the Castlebar lines affected by the endotoxin issue has been submitted.
Maltese: Bħala miżura addizzjonali, ġie ppreżentat pjan ta' ġestjoni tar-riskju (risk management plan - RMP) ikkonsolidat speċifiku għat-tnedija mill-ġdid tas-soluzzjonijiet għad-dijaliżi mmanifatturati fil-linji ta' Castlebar affettwati mill-kwistjoni tal-endotossina.
English: Focus should be given to the timeliness of communication of safety signals to healthcare professionals and competent authorities, and the accuracy and consistency of the systems in place to collect safety information and provide it to the regulatory networks.
Maltese: Għandha tingħata attenzjoni lill-puntwalità fil-komunikazzjoni tas-sinjali tas-sigurtà lill-professjonisti tal-kura tas-saħħa u lill-awtoritajiet kompetenti, u l-eżattezza u l-konsistenza tas-sistemi stabbiliti għall-ġbir tal-informazzjoni tas-sigurtà u t-twassil tagħha lin-netwerks regolatorji.
English: The MAH should submit the relevant data to national competent authorities for review, in line with the agreed milestones for evaluation and reporting as described in the RMP.
Maltese: Il-MAH għandu jissottometti d-dejta rilevanti lill-awtoritajiet nazzjonali kompetenti għall-analiżi, f'konformità mal-miri miftiehma għall-evalwazzjoni u r-rappurtar kif deskritt fl-RMP.