FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC for Numeta G16%E;
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 107i tad-Direttiva 2001/83/KE għal Numeta G16%E;
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC for Numeta G13%E;
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 107i tad-Direttiva 2001/83/KE għal Numeta G13%E;
English: Numeta G16% Whereas,
Maltese: Numeta G16% Billi,
English: The kidney is the main regulatory organ of magnesium homeostasis and impaired renal function is the most common cause of hypermagnesemia in children (Ali et al, 2003).
Maltese: Il-kliewi huma l-organi regolatorji prinċipali tal-omeostasi tal-manjesju u funzjoni renali indebolita hija laktar kawża komuni ta' ipermagnesimja fit-tfal (Ali et al, 2003).
English: Magnesium also plays a critical role in maintaining normal nerve and muscle function, cardiac excitability, neuromuscular conduction, muscular contraction, vasomotor tone and for a balanced immune response (Brandao et al, 2013).
Maltese: Il-manjesju għandu wkoll rwol importanti ħafna fiżżamma tal-funzjonijiet normali tan-nervituri u l-muskoli, l-eċċitabbiltà kardijaka, il-konduzzjoni newromuskolari, il-kontrazzjoni muskolari, it-ton vażomotorili u għal rispons immuni bbilanċjat (Brandao et al, 2013).
English: Parenteral nutrition (PN) is the use of intravenous macronutrients, electrolytes, micronutrients and fluids to provide nutritional support in patients who cannot be fed by oral or enteral nutrition.
Maltese: Nutrizzjoni parenterali (PN) hija l-użu ta' makronutrijenti, elettroliti, mikronutrijenti u fluwidi ġol-vini biex jipprovdu appoġġ nutrizzjonali f'pazjenti li ma jistgħux jintemgħu b'nutrizzjoni orali jew enterali.
English: The safety concerns of Numeta products outlined in the initial application and risk management plan include drug administration errors, use of Numeta in patients with hypersensitivity to one of the components, use of Numeta in patients with severe metabolic disease, catheter-related infection and sepsis, re-feeding syndrome, use of Numeta in patients with certain organ impairment and extravasation and thrombophlebitis when peripherally administered.
Maltese: It-tħassib dwar is-sigurtà tal-prodotti Numeta deskritti fl-applikazzjoni inizjali u fil-pjan għall-ġestjoni tarriskju jinkludi żbalji fl-għoti tal-mediċina, l-użu ta' Numeta f'pazjenti b'sensittività eċċessiva għal xi wieħed mill-komponenti, l-użu ta' Numeta f'pazjenti b'mard metaboliku serju, infezzjonijiet u sepsis relatati malkateter, is-sindromu ta' tmigħ mill-ġdid, l-użu ta' Numeta f'pazjenti b'ċertu indeboliment tal-organi u estravażjoni u tromboflebite meta jingħata b'mod periferali.
English: In addition, recent data highlighted by the PDCO suggest paediatric reference ranges for magnesium may be higher than previously thought (Canadian Laboratory Initiative on PEdiatric Reference Intervals [CALIPER]1).
Maltese: Barra minn hekk, dejta riċenti enfasizzata mill-PDCO tissuġġerixxi li l-meded ta' referenzi pedjatriċi għall-manjesju jistgħu jkunu ogħla milli kien maħsub qabel (Canadian Laboratory Initiative on PEdiatric Reference Intervals (Inizjattiva tal-Laboratorju Kanadiż dwar l-Intervalli ta' Referenza Pedjatrika) [CALIPER]1).
English: Considering uncertainties regarding the appropriateness of the levels of magnesium in Numeta G13%E and the clinical consequences of this along with uncertainties regarding the availability of adequate alternatives across the EU member states, the Swedish competent authority notified the EMA, in accordance with Article 107i of Directive 2001/83/EC, of the urgency to undertake a review and requesting the PRAC to give a recommendation on the benefit-risk balance of Numeta G13%.
Maltese: Wara li kkunsidra l-inċertezzi dwar l-adegwatezza tal-livelli ta' manjesju f'Numeta G13%E u l-konsegwenzi kliniċi ta' dan flimkien mal-inċertezzi dwar id-disponibbiltà ta' alternattivi adegwati madwar l-Istati Membri tal-UE, l-awtorità kompetenti Svediża nnotifikat lill-EMA, skont l-Artikolu 107i tad-Direttiva 2001/83/KE, dwar l-urġenza biex twettaq reviżjoni u talbet lill-PRAC jagħti rakkomandazzjoni dwar il-bilanċ bejn ilbenefiċċju u r-riskju ta' Numeta G13%.
English: In view of the safety concerns in relation to hypermagnesemia in the vulnerable indicated patient population (preterm neonates) arising from the magnesium content in the current formulation of Numeta G13%E and taking account of the reported cases and the available evidence from literature and guidelines, the PRAC concluded that pursuant to Article 116 of Directive 2001/83/EC the benefitrisk balance of Numeta G13%E as parenteral nutrition for preterm newborn infants for whom oral or enteral nutrition is not possible, insufficient or contraindicated is no longer favourable.
Maltese: Fid-dawl tat-tħassib dwar is-sigurtà fir-rigward ta' ipermagnesimja fil-popolazzjoni vulnerabbli ta' pazjenti indikata (trabi tat-twelid li jitwieldu qabel iż-żmien) bħala riżultat tal-kontenut ta' manjesju filformulazzjoni attwali ta' Numeta G13%E u b'kunsiderazzjoni tal-każijiet irrapportata u l-evidenza disponibbli mid-dokumentazzjoni u l-linji gwida, il-PRAC ikkonkluda li skont l-Artikolu 116 tadDirettiva 2001/83/KE l-bilanċ bejn il-benefiċċju u r-riskju ta' Numeta G13%E bħala nutrizzjoni parenterali għat-trabi tat-twelid li jitwieldu qabel iż-żmien li għalihom in-nutrizzjoni orali jew enterali ma tkunx possibbli, biżżejjed jew tkun kontraindikata ma għadux favorevoli.
English: Numeta has been registered through the decentralised procedure (DCP) in Europe in 18 countries.
Maltese: Numeta ġie rreġistrat permezz tal-proċedura deċentralizzata (DCP) fl-Ewropa fi 18-il pajjiż.
English: The CMDh, having considered the PRAC recommendation dated 5 September 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the suspension of the marketing authorisations for Numeta G13%E.
Maltese: Is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata l-5 ta' Settembru 2013 skont lArtikolu 107k(1) u (2) tad-Direttiva 2001/83/KE, laħaq ftehim dwar is-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal Numeta G13%E.
English: Neonatal hypermagnesemia can also be caused by increased magnesium load such as with maternal magnesium sulphate administration for preeclampsia, newborn magnesium therapy, or decreased renal magnesium excretion due to prematurity and asphyxia (Hyun et al, 2011).
Maltese: L-ipermagnesimja fit-trabi tat-twelid tista' wkoll tkun ikkawżata minn żieda fit-tagħbija ta' manjesju bħall-għoti ta' sulfat tal-manjesju lill-omm għal preeklampsja, terapija b'manjesju fit-trabi tat-twelid, jew tnaqqis fl-eliminazzjoni renali tal-manjesju minħabba prematurità u asfissija (Hyun et al, 2011).
English: Severe hypomagnesemia is uncommon but can cause seizures, drowsiness, cardiac ventricular defibrillation, hypokalemia and hypocalcemia (Whang et al, 1994).
Maltese: L-ipomagnesimja severa mhijiex komuni, iżda tista' tikkawża aċċessjonijiet, ngħas, defibrillazzjoni ventrikulari tal-qalb, ipokalimja u ipokalċimja (Whang et al, 1994).
English: PN solutions are delivered through a peripheral or central venous catheter.
Maltese: Soluzzjonijiet PN jitwasslu permezz ta' kateter periferali jew ċentrali ġol-vina.
English: Numeta G16%E Having considered the overall submitted data provided by the MAH in writing, the stakeholder's submission and the PDCO advice, the PRAC concluded that: a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study; b. the marketing authorisation holders should implement risk minimisation measures; c. the marketing authorisations should be varied.
Maltese: Numeta G16%E Wara li kkunsidra d-dejta kollha sottomessa pprovduta mill-MAH bil-miktub, is-sottomissjoni tal-parti interessata u l-parir tal-PDCO, il-PRAC ikkonkluda li: a. id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom jisponsorjaw studju dwar is-sigurtà wara l-awtorizzazzjoni flimkien mal-valutazzjoni ta' segwitu tar-riżultati ta' dak l-istudju; b. id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom jimplimentaw miżuri għallminimizzazzjoni tar-riskji; c. l-awtorizzazzjonijiet għat-tqegħid fis-suq għandhom jiġu varjati.
English: Considering the number of cases of hypermagnesemia reported with Numeta G13%, the vulnerability of the patient population, difficulties in recognising clinical symptoms of hypermagnesaemia in this patient population and the content of Magnesium in Numeta G13%E in the context of relevant recommendations for magnesium intake in guidelines and literature, the MAH identified the need for reformulation the product.
Maltese: Minħabba l-għadd ta' każijiet ta' ipermagnesimja rrapportata b'Numeta G13%, il-vulnerabbiltà talpopolazzjoni ta' pazjenti, id-diffikultajiet biex is-sintomi kliniċi tal-ipermagnesimja jiġu rikonoxxuti f'din ilpopolazzjoni ta' pazjenti u l-kontenut ta' Manjesju f'Numeta G13%E fil-kuntest ta' rakkomandazzjonijiet rilevanti għat-teħid tal-manjesju fil-linji gwida u d-dokumentazzjoni, l-MAH identifika l-ħtieġa għal riformulazzjoni tal-prodott.
English: The ESPEN/ESPGHAN guideline recommends a lower magnesium intake of 0.2mmol/kg/d for infants of 0-12 months of age and 0.1mmol/kg/d for children between 1 to 13 years of age.
Maltese: Il-linja gwida tal-ESPEN/ESPGHAN tirrakkomanda teħid aktar baxx ta' manjesju ta' 0.2mmol/kg/d għal trabi ta' 0-12-il xahar u ta'0.1mmol/kg/d għal tfal bejn is-1 sa 13-il sena.
English: To date there has been only one report of hypermagnesaemia received for Numeta G16%E (magnesium level 1.14 mmol/L) but this report was confounded because Numeta G16% E was supplemented with additional magnesium administration and no associated adverse events were reported.
Maltese: Sal-lum kien hemm rapport wieħed biss ta' ipermagnesimja riċevut għal Numeta G16%E (livell ta' manjesju ta' 1.14 mmol/L) iżda dan ir-rapport kien imfixkel minħabba li Numeta G16% E kien issupplimentat bl-għoti ta' manjesju addizzjonali u ma kienu rrapportati l-ebda avvenimenti avversi assoċjati.
English: The CMDh, having considered the PRAC recommendation dated 5 September 2013 with regards to Numeta G13%E and Numeta G16%E agrees with the overall PRAC scientific conclusions and grounds for the conclusions therein as stated below:
Maltese: Konklużjonijiet xjentifiċi u r-raġunijiet għall-konklużjonijiet Is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata l-5 ta' Settembru 2013 fir-rigward ta' Numeta G13%E u Numeta G16%E jaqbel mal-konklużjonijiet xjentifiċi ġenerali tal-PRAC u r-raġunijiet għall-konklużjonijiet li hemm fiha kif iddikjarat hawn taħt:
English: • The PRAC reviewed all available data from clinical studies, published literature, post-marketing experience on the safety and efficacy of Numeta G13%E in particular with regards to the risk of hypermagnesemia, as well as the stakeholder's submission and the PDCO advice;
Maltese: • Il-PRAC irreveda d-dejta kollha disponibbli minn studji kliniċi, mid-dokumentazzjoni ppubblikata, lesperjenza wara t-tqegħid fis-suq dwar is-sigurtà u l-effikaċja ta' Numeta G13%E b'mod partikolari firrigward tar-riskju ta' ipermagnesimja, kif ukoll is-sottomissjoni tal-parti interessata u l-parir tal-PDCO;
English: the first few months after birth and the immature kidney has limited adaptability in case of excess administrations of electrolytes, monitoring of serum magnesium levels should mitigate the potential risk, with initial monitoring at baseline and frequency of follow-up monitoring determined by the clinical circumstances and routine clinical practice.
Maltese: ewwel ftit xhur wara t-twelid u l-kliewi immaturi għandhom adattabbiltà limitata fil-każ tal-għoti eċċessiv ta' elettroliti, il-monitoraġġ tal-livelli ta' manjesju fis-serum għandu jtaffi r-riskju potenzjali, b'monitoraġġ inizjali fil-linja bażi u l-frekwenza tal-monitoraġġ ta' segwitu tiġi ddeterminata miċ-ċirkostanzi kliniċi u lprattika klinika ta' rutina.
English: The PRAC, considering all evidence available, including the PDCO advice, concluded that the risk of hypermagnesaemia is enhanced by both the clinical complexity of identifying the symptoms in this patient population and the fact that renal clearance of magnesium is decreased in neonates leading to the potential for persistence of increased magnesium levels (Mittendorf et al, 2001).
Maltese: Il-PRAC, wara li kkunsidra l-evidenza kollha disponibbli, inkluż il-parir tal-PDCO, ikkonkluda li r-riskju ta' ipermagnesimja jiżdied kemm bil-kumplessità klinika li jiġu identifikati s-sintomi f'din il-popolazzjoni ta' pazjenti u l-fatt li t-tneħħija tal-manjesju mill-kliewi hija mnaqqsa fit-trabi tat-twelid li jwassal għallpotenzjal għall-persistenza ta' żieda fil-livelli ta' manjesju (Mittendorf et al, 2001).
English: In order to receive on the third day 4g amino acids/kg/d, the preterm infant would receive 127.7 ml/kg/d or 0.55 mmol/kg/d of magnesium.
Maltese: Sabiex fit-tielet ġurnata t-tarbija li twieldet qabel iż-żmien tirċievi 4g ta' aċidi amminiċi/kg/d, għandha tirċievi 127.7 ml/kg/d jew 0.55 mmol/kg/d ta' manjesju.
English: Scientific conclusions and grounds for the conclusions
Maltese: Konklużjonijiet xjentifiċi u r-raġunijiet għall-konklużjonijiet
English: A DHPC was agreed, together with the timelines for distribution;
Maltese: Ġiet miftiehma DHPC, flimkien ma' skeda għaddistribuzzjoni;
English: The MAH identified 14 case reports of hypermagnesaemia or increased magnesium associated with Numeta G13%E in their global safety database and 1 case associated with Numeta G16%.
Maltese: Il-MAH identifika 14-il rapport ta' każijiet ta' ipermagnesimja jew ta' żieda fil-manjesju marbuta ma' Numeta G13%E fid-database dwar is-sigurtà globali tagħhom u każ 1 marbut ma' Numeta G16%.
English: The PRAC in accordance with Article 107j(3) of Directive 2001/83/EC, recommends by consensus that a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study (see Annex V - Conditions of marketing Authorisations);
Maltese: Il-PRAC skont l-Artikolu 107j(3) tad-Direttiva 2001/83/KE, jirrakkomanda b'kunsens li a. id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom jisponsorjaw studju wara lawtorizzazzjoni dwar is-sigurtà flimkien ma' valutazzjoni ta' segwitu tar-riżultati ta' dak l-istudju (ara l-Anness V - Kondizzjonijiet tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq);
English: • The PRAC concluded that there is a risk for hypermagnesaemia when Numeta G13%E is administered to preterm newborn infants.
Maltese: • Il-PRAC ikkonkluda li hemm riskju ta' ipermagnesimja meta Numeta G13%E jingħata lit-trabi tat-twelid li jitwieldu qabel iż-żmien.
English: These risks are considered to be complications of PN use in general as outlined in the joint paper on paediatric PN the European society of paediatric gastroenterology, hepatology and nutrition (ESPGHAN) and the European society for clinical nutrition and metabolism (ESPEN).
Maltese: Dawn ir-riskji huma meqjusa komplikazzjonijiet tal-użu ta' PN in ġenerali kif deskritt fid-dokument konġunt dwar il-PN pedjatrika tassoċjetà Ewropea tal-gastroenteroloġija, l-epatoloġija u n-nutrizzjoni pedjatrika (ESPGHAN) u s-soċjetà Ewropea għan-nutrizzjoni u l-metaboliżmu kliniku (ESPEN).
English: • The PRAC is of the opinion that there is a potential risk for hypermagnesaemia when Numeta G16%E is administered to term newborn infants and children up to two years, particularly in patients with reduced renal function, and newborn infants of mothers who were receiving supplemental magnesium prior to delivery;
Maltese: • Il-PRAC huwa tal-opinjoni li hemm riskju potenzjali ta' ipermagnesimja meta Numeta G16%E jingħata lil trabi tat-twelid li jitwieldu wara 37 ġimgħa ta' ġestazzjoni u lil tfal sa sentejn, b'mod partikolari f'pazjenti b'funzjoni renali mnaqqsa, u lil trabi tat-twelid li l-omm kienet qed tirċievi manjesju supplementari qabel il-ħlas;
English: Based on the currently available information, the benefit-risk balance of Numeta G16%E is considered to remain favourable subject to the warnings, additional pharmacovigilance activities and additional risk minimisation measures agreed.
Maltese: Abbażi tal-informazzjoni attwalment disponibbli, il-bilanċ bejn il-benefiċċju u r-riskju ta' Numeta G16%E huwa meqjus li għadu favorevoli soġġett għat-twissijiet, l-attivitajiet addizzjonali ta' farmakoviġilanza u lmiżuri addizzjonali għall-minimizzazzjoni tar-riskji miftiehma.
English: Overall summary of the scientific evaluation of Numeta G13%E and Numeta G16%E by PRAC
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' Numeta G13%E u Numeta G16%E mill-PRAC
English: The risk of hypermagnesemia and all measures considered necessary to mitigate this risk (i.e. agreed additional pharmacovigilance activities, as listed above and risk minimisation activities such as direct healthcare professional communication (DHPC), changes to the product information) should be reflected in a revised risk management plan (RMP), which should also include proposals for evaluating the effectiveness of the risk minimisation activities.
Maltese: Ir-riskju ta' ipermagnesimja u l-miżuri kollha meqjusa neċessarji biex dan ir-riskju jittaffa (jiġifieri lattivitajiet addizzjonali ta' farmakoviġilanza miftiehma, kif elenkati hawn fuq u l-attivitajiet għallminimizzazzjoni tar-riskji bħal komunikazzjoni diretta lill-professjonisti tal-kura tas-saħħa (DHPC), tibdil flinformazzjoni dwar il-prodott) għandhom ikunu riflessi fi pjan rivedut għall-ġestjoni tar-riskju (RMP), li għandu jinkludi wkoll proposti għall-valutazzjoni tal-effikaċja tal-attivitajiet għall-minimizzazzjoni tar-riskji.
English: Consequently there is a potential risk for hypermagnesemia particularly in patients with reduced renal function.
Maltese: Konsegwentement hemm riskju potenzjali ta' ipermagnesimja partikolarment f'pazjenti b'funzjoni renali mnaqqsa.
English: Additionally, the PRAC took account of differences in the indicated population for Numeta G16%E versus Numeta G13%E and that full term neonates and children up to two years have further progressed in terms of nephrogenic development.
Maltese: Barra minn hekk, il-PRAC ħa kont tad-differenzi fil-popolazzjoni indikata għal Numeta G16%E kontra Numeta G13%E u li trabi tat-twelid li jitwieldu wara 37 ġimgħa ta' ġestazzjoni u tfal sa sentejn komplew jipprogressaw f'termini ta' żvilupp nefroġeniku.
English: The PRAC concluded that the benefit-risk balance of Numeta G16%E for parenteral nutrition in term newborn infants and children up to two years when oral or enteral nutrition is not possible, insufficient or contraindicated remains favourable subject to the warnings, additional pharmacovigilance activities and additional risk minimisation measures agreed.
Maltese: Il-PRAC ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju ta' Numeta G16%E għan-nutrizzjoni parenterali fi trabi tat-twelid li jitwieldu wara 37 ġimgħa ta' ġestazzjoni u fi tfal sa sentejn meta n-nutrizzjoni orali jew enterali ma tkunx possibbli, biżżejjed jew tkun kontraindikata jibqa' favorevoli soġġett għat-twissijiet, lattivitajiet addizzjonali ta' farmakoviġilanza u l-miżuri addizzjonali għall-minimizzazzjoni tar-riskji miftiehma.
English: Most patients with hypomagnesemia show no acute symptoms but it can still lead to osteoporosis and is correlated to increased inflammation and metabolic syndrome.
Maltese: Ħafna mill-pazjenti b'ipomagnesimja ma juru l-ebda sintomi akuti iżda xorta jista' jwassal għall-osteoporożi u huwa korrelatat ma' żieda fl-infjammazzjoni u s-sindrome metaboliku.
English: • The PRAC also concluded that there was need for further risk minimisation measures such as information to healthcare professionals.
Maltese: • Il-PRAC ikkonkluda wkoll li kien hemm il-ħtieġa ta' aktar miżuri għall-minimizzazzjoni tar-riskji bħal informazzjoni lill-professjonisti tal-kura tas-saħħa.
English: Hypermagnesaemia is a serious clinical condition which can lead to generalised weakness, respiratory failure, hypotension, arrhythmias (especially if not otherwise explained by the clinical condition of the infant/child).
Maltese: L-ipermagnesimja hija kundizzjoni klinika serja li tista' twassal għal dgħjufija ġeneralizzata, insuffiċjenża respiratorju, pressjoni baxxa, arritmiji (speċjalment jekk ma jkunux spjegati b'mod ieħor mill-kondizzjoni klinika tat-trabi/tfal).
English: Having considered the overall submitted data provided by the MAH in writing, the stakeholder's submission and the PDCO advice, the PRAC concluded that the benefit-risk balance of Numeta G13%E for parenteral nutrition in preterm newborn infants when oral or enteral nutrition is not possible, insufficient or contraindicated is no longer favourable.
Maltese: Wara li kkunsidra d-dejta kollha sottomessa pprovduta mill-MAH bil-miktub, is-sottomissjoni tal-parti interessata u l-parir tal-PDCO, il-PRAC ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju ta' Numeta G13%E għan-nutrizzjoni parenterali fit-trabi tat-twelid li jitwieldu qabel iż-żmien meta n-nutrizzjoni orali jew enterali ma tkunx possibbli, biżżejjed jew tkun kontraindikata ma għadux favorevoli.
English: • The PRAC also concluded that a prospective non-interventional post-authorisation safety study should be conducted to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated with Numeta G16%E in routine clinical practice.
Maltese: • Il-PRAC ikkonkluda wkoll li għandu jsir studju prospettiv mhux ta' intervent wara l-awtorizzazzjoni dwar is-sigurtà biex ikomplu jiġu vvalutati l-livelli ta' manjesju osservati fit-trabi tat-twelid li jitwieldu wara 37 ġimgħa ta' ġestazzjoni u fit-tfal sa sentejn li jirċievu kura b'Numeta G16%E fil-prattika klinika ta' rutina.
English: The PRAC therefore recommended the suspension of the marketing authorisation for Numeta G13%E.
Maltese: Il-PRAC għalhekk irrakkomanda s-sospensjoni tal-awtorizzazzjoni għat-tqegħid fis-suq għal Numeta G13%E.
English: A prospective non-interventional post-authorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated with Numeta G16%E in routine clinical practice should be conducted.
Maltese: Għandu jsir studju prospettiv mhux ta' intervent wara l-awtorizzazzjoni dwar is-sigurtà biex ikomplujiġu vvalutati l-livelli ta' manjesju osservati fit-trabi tat-twelid li jitwieldu wara 37 ġimgħa ta' ġestazzjoni u fi tfal sa sentejn li qed jirċievu kura b'Numeta G16%E fil-prattika klinika ta' rutina.
English: Although no reports had been received for Numeta G16%E, the PRAC decided at its June 2013 meeting that this product would also be included in the scope of the referral because of its magnesium content and because of its use in neonates and infants/toddlers up to the age of 2 years, who may also be at risk of developing hypermagnesaemia.
Maltese: Għalkemm ma wasslu l-ebda rapporti għal Numeta G16%E, waqt il-laqgħa tiegħu ta' Ġunju 2013 il-PRAC iddeċieda li dan il-prodott kien ser jiġi inkluż ukoll fil-kamp ta' applikazzjoni tar-riferiment minħabba lkontenut ta' manjesju tiegħu u minħabba l-użu tiegħu fi trabi tat-twelid u fi trabi/tfal żgħar sa sentejn, li jistgħu ukoll ikunu f'riskju li jiżviluppaw ipermagnesimja.
English: Therefore, following the provisions under Article 107j(3) of Directive 2001/83/EC, the PRAC recommends the suspension of the marketing authorisations for Numeta G13%E.
Maltese: Għalhekk, skont id-dispożizzjonijiet li jinsabu fl-Artikolu 107j(3) tad-Direttiva 2001/83/KE, il-PRAC jirrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal Numeta G13%E.