FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant presented data from two main studies in 356 anaemic patients with myelodysplastic syndromes.
Maltese: L-applikant ippreżenta data minn żewġ studji prinċipali f'356 pazjent anemiku b'sindromi majelodisplastiċi.
English: • adults and children with ‘chronic renal failure' (long-term, progressive decrease in the ability of the kidneys to work properly);
Maltese: • adulti u tfal li jkollhom “indeboliment kroniku renali” (tnaqqis progressiv u fit-tul fl-abbiltà tal-kliewi biex jaħdmu sew);
English: On 21 February 2018, Amgen Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application to add treatment of anaemia in adult patients with myelodysplastic syndromes to the existing marketing authorisation.
Maltese: Fil-21 ta' Frar 2018, Amgen Europe B.V. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha biex tiżdied il-kura talanemija fil-pazjenti adulti b'sindromi majelodisplastiċi mal-awtorizzazzjoni eżistenti għat-tqegħid fissuq.
English: Aranesp has been authorised since June 2001.
Maltese: Aranesp ilu awtorizzat minn Ġunju 2001.
English: What was Aranesp expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Aranesp?
English: Aranesp was also expected to be used to treat anaemia in patients with myelodysplastic syndromes, a group of bone marrow disorders.
Maltese: Aranesp kien mistenni wkoll li jintuża biex jikkura l-anemija f'pazjenti b'sindromi majelodisplastiċi, grupp ta' disturbi tal-mudullun.
English: Aranesp is a medicine already used to treat anaemia (low red-blood-cell count) that is causing symptoms in the following groups of patients:
Maltese: Aranesp huwa mediċina li tintuża diġà biex tiġi kkurata l-anemija (għadd baxx ta' ċelloli ħomor taddemm) li qed tikkawża sintomi fil-gruppi ta' pazjenti li ġejjin:
English: • adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer not originating in the bone marrow).
Maltese: • adulti li qed jieħdu kimoterapija għall-kanċer “mhux majelojde” (kanċer li ma joriġinax fil mudullun).
English: This means that darbepoetin alfa has a longer duration of action, and can be given less often than natural erythropoietin.
Maltese: Dan ifisser li darbepoetina alfa għandha tul ta' azzjoni itwal, u tista' tingħata inqas spiss mill-eritropojetina naturali.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Aranesp could not have been approved for the treatment of anaemia in adult patients with myelodysplastic syndromes.
Maltese: Fuq il-bażi tar-rieżami tad-data, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-idea provviżorja li Aranesp ma setax jiġi approvat għall-kura ta' anemija f'pazjenti adulti b'sindromi majelodisplastiċi.
English: Aranesp, acts exactly like a natural hormone called erythropoietin that is made by the kidneys to stimulate red blood cell production, but it is very slightly different in its structure.
Maltese: Darbepoetina alfa, is-sustanza attiva f'Aranesp, taġixxi eżattament bħal ormon naturali bl-isem ta' eritropojetina li jsir mill-kliewi biex jistimula lproduzzjoni taċ-ċelloli ħomor tad-demm, iżda huwa ftit differenti fl-istruttura tiegħu.
English: The first study compared Aranesp with placebo (a dummy treatment) over 24 weeks.
Maltese: L-ewwel studju qabbel lil Aranesp ma' plaċebo (kura finta) fuq perjodu ta' 24 ġimgħa.
English: The medicine was to be used in patients who did not need frequent blood transfusions and who had a low or intermediate risk of their condition progressing to acute myeloid leukaemia (AML, a type of cancer affecting white blood cells).
Maltese: Il-mediċina kellha tintuża f'pazjenti li ma kellhomx bżonn ta' trasfużjonijiet frekwenti tad-demm u li kellhom riskju baxx jew intermedju li l-kundizzjoni tagħhom tiżviluppa f'lewkimja majelojde akuta (AML, tip ta' kanċer li jaffettwa ċ-ċelloli bojod tad-demm).
English: The company informed the Agency that there are no Amgen-sponsored ongoing clinical trials with Aranesp.
Maltese: Il-kumpanija infurmat lill-Aġenzija li ma hemm l-ebda prova klinika b'Aranesp sponsorjata minn Amgen li tinsab għaddejja.
English: AAP Publications Retired or Reaffirmed, October 2006.
Maltese: AAP Publications Retired or Reaffirmed, Ottubru 2006.
English: The children's age ranged from 17 days to 6 years.
Maltese: L-età tat-tfal kienet tvarja minn 17-il jum sa 6 snin.
English: 1 Article 31 pharmacovigilance referral for codeine used for management of pain in paediatric patients (EMA/H/A-31/1342) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Codeinecontaining_medicines/human_referral_prac_000008.jsp&mid=WC0b01ac05805c516f symptomatic treatment of cough and/or cold as current evidence does not find codeine to be more effective than placebo for acute cough in children.
Maltese: 1 Riferiment tal-farmakoviġilanza skont l-Artikolu 31 għall-kodeina użata għall-ġestjoni tal-uġigħ f'pazjenti pedjatriċi(EMA/H/A-31/1342) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Codeinecontaining_medicines/human_referral_prac_000008.jsp&mid=WC0b01ac05805c516f
English: The large majority of childhood respiratory infections with cough are caused by viral infections, which are self-limiting and only last for a few days whereas in the case of chronic cough, treatment should be directed at the underlying disease2,3 (American Academy of Paediatrics Committee on Drugs 1997, American Academy of Paediatrics, AAP publications retired or reaffirmed 2006).
Maltese: Il-maġġoranza l-kbira ta' infezzjonijiet respiratorji fit-tfal bis-sogħla huma kkawżati minn infezzjonijiet virali, li huma awtolimitanti u jdumu ftit jiem biss filwaqt li fil-każ ta' sogħla kronika, il-kura għandha tiġi diretta lejn il-marda sottostanti2,3 (American Academy of Paediatrics Committee on Drugs 1997, American Academy of Paediatrics, AAP publications retired or reaffirmed 2006).
English: Codeine is converted into morphine in the body by cytochrome P450 2D6 (CYP2D6), an enzyme which shows genetic polymorphism.
Maltese: Fil-ġisem, il-kodeina tiġi konvertita f'morfina miċ-ċitokromju P450 2D6 (CYP2D6), enzima li turi polimorfiżmu ġenetiku.
English: Individuals are normally classified as poor (PM), extensive (EM) or ultrarapid metabolisers (UM), depending on the activity of the enzyme.
Maltese: Normalment, individwi jiġu klassifikati bħala metabolizzaturi dgħajfa (PM), estensivi (EM) jew ultra-rapidi (UM), skont l-attività tal-enzima.
English: A randomised clinical trial (Jaffe G et al, 1983) and an epidemiological study (De Blasio F et al, 2012) did not show a significant effect of the treatment with codeine in cough and/or cold in children.
Maltese: Prova klinika randomizzata (Jaffe G et al, 1983) u studju epidemjoloġiku (De Blasio F et al, 2012) ma wrewx effett sinifikanti tal-kura bil-kodeina fis-sogħla u/jew f'riħ fit-tfal.
English: Data analyses from the Eudravigilance database identified a total of 50 case reports that could be related to opiate toxicity, of which 31 cases were in those younger than 6 years (including 4 fatal cases), 7 cases in older than 6 years and younger than 12 years (including 1 fatal case) and the remaining 12 cases were on those older than 12 and younger than 18 years (including 1 fatal case).
Maltese: Analiżi tad-data mill-bażi tad-data Eudravigilance identifikat total ta' 50 rapport ta' każijiet li jistgħu jkunu relatati ma' tossiċità bl-opjati, li minn dawn 31 każ kienu f'dawk iżgħar minn 6 snin (inkluż 4 każijiet fatali), 7 każijiet fi tfal ta' aktar minn 6 snin u iżgħar minn 12-il sena (inkluż każ fatali) u t-12-il każ li baqa' kienu fuq dawk li kellhom aktar minn 12-il sena u inqas minn 18-il sena (inkluż każ fatali wieħed).
English: In 2012, the Taylor et al study was included in a Cochrane review of non-prescription/over-the-counter (OTC) medications for acute cough in children and adults in ambulatory settings; this review additionally identified two randomised controlled trials where codeine was tested in adults (Eccles et al, 1992; Freestone C, 1997): codeine was found to be no more effective than placebo.
Maltese: Fl-2012, listudju ta' Taylor et al ġie inkluż f'rieżami ta' Cochrane ta' mediċini mingħajr preskrizzjoni medika/li jinxtraw mingħajr riċetta (OTC - over-the-counter) għal sogħla akuta fit-tfal u fl-adulti f'ambjenti ambulatorji; barra minn hekk dan ir-rieżami identifika żewġ provi kkontrollati u randomizzati fejn ilkodeina ġiet ittestjata fl-adulti (Eccles et al, 1992; Freestone C, 1997): il-kodeina nstabet li ma kinitx aktar effettiva mill-plaċebo.
English: Cough is a reflex response to mechanical, chemical, or inflammatory irritation of the tracheobronchial tree.
Maltese: Is-sogħla hija rispons awtomatiku (reflex) għal irritazzjoni mekkanika, kimika, jew infjammatorja talfergħa trakeobronkjali.
English: Two studies (Kelly et al, 1963 and Jaffe et al, 1983), which did not include a placebo control group, suggested that efficacy was no greater for codeine than the other antitussives but that the incidence of side effects in the codeine group was higher than in the comparator group.
Maltese: Żewġ studji (Kelly et al, 1963 u Jaffe et al, 1983), li ma inkludewx grupp ta' kontroll bi plaċebo, issuġġerixxew li l-kodeina ma kinitx aktar effikaċi minn antitussivi oħrajn iżda li l-inċidenza ta' effetti sekondarji fil-grupp tal-kodeina kienet ogħla milli filgrupp komparatur.
English: Overall, the majority (38/50) of the cases were in patients younger than 12 years of age and 6 were fatal cases.
Maltese: B'kollox, ilmaġġoranza (38/50) tal-każijiet kienu f'pazjenti iżgħar minn 12-il sena u 6 kienu każijiet fatali.
English: • The PRAC considered that there is limited evidence that support the efficacy of codeine in cough and cold and that these are generally self-limiting conditions.
Maltese: • Il-PRAC qies li hemm evidenza limitata li tappoġġja l-effikaċja tal-kodeina fis-sogħla u f'riħ u li ġeneralment dawn huma kundizzjonijiet awtolimitanti.
English: Whereas EMs or UMs are at risk of morphine toxicity, PMs may be at an increased risk of a lack of therapeutic effect.
Maltese: Filwaqt li EMs jew UMs huma f'riskju ta' tossiċità minħabba l-morfina, PMs jistgħu jkunu f'riskju akbar ta' nuqqas ta' effett terapewtiku.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for codeine containing medicinal products for the treatment of cough and/or cold in children.
Maltese: • Il-PRAC qies il-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE li rriżultat minn data ta' farmakoviġilanza għal prodotti mediċinali li fihom il-kodeina għall-kura ta' sogħla u/jew ta' riħ fit-tfal;
English: The PRAC reviewed all available data from different sources: clinical trials, observational studies, metaanalyses, post-marketing data and further published literature data on the use of codeine containing products in children for treatment of cough and/or cold.
Maltese: Il-PRAC irreveda d-data kollha disponibbli minn sorsi differenti: provi kliniċi, studji ta' osservazzjoni, meta-analiżi, data wara t-tqegħid fis-suq u data ulterjuri minn letteratura ppubblikata dwar l-użu ta' prodotti li fihom il-kodeina fit-tfal għall-kura ta' sogħla u/jew ta' riħ.
English: Codeine was subject of an Article 31 referral to the PRAC in 20131, when used for pain relief in the paediatric population (hereafter refer as “children”) due to concerns regarding opioid toxicity and the lack of consistent risk minimisation measures raised following cases described in the literature of fatal or life-threatening respiratory depression, when codeine was given to children after adenoidectomy/tonsillectomy for obstructive sleep apnoea.
Maltese: Fl-2013, il-kodeina kienet is-suġġett ta' riferiment skont l-Artikolu 31 lill-PRAC1, meta tintuża għasserħan mill-uġigħ fil-popolazzjoni pedjatrika (minn hawn ‘il quddiem imsejħa “tfal”) minħabba tħassib dwar tossiċità bl-opjojdi u n-nuqqas ta' miżuri konsistenti tal-imminimizzar tar-riskju li qamu wara każijiet deskritti fil-letteratura ta' dipressjoni respiratorja fatali jew ta' periklu għall-ħajja, meta lkodeina ngħatat lil tfal wara adenojdektomija/tneħħija kirurġika tat-tunsilli għal apnea ostruttiva waqt l-irqad.
English: Codeine, also known as methylmorphine, binds to µ-opioid receptors to produce analgesia and euphoria, as well as respiratory depression, miosis, and reduced gastric motility.
Maltese: Il-kodeina, magħrufa wkoll bħala methylmorphine, tintrabat mar-riċetturi μ-opjojdi biex tipproduċi analġeżija u ewforija, kif ukoll dipressjoni respiratorja, mijożi, u tnaqqis fil-motilità gastrika.
English: The PRAC took into account that the enzymatic systems responsible for the metabolism of codeine in children older than 12 years of age can be considered comparable to that of adults.
Maltese: Il-PRAC qies li s-sistemi enzimatiċi responsabbli għall-metaboliżmu tal-kodeina fi tfal ta' aktar minn 12il sena jistgħu jitqiesu bħala komparabbli ma' dawk tal-adulti.
English: The PRAC further concluded that codeine should be contraindicated in paediatric patients below 18 years of age undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome as well as in women during breast-feeding and in patients known to be CYP2D6 ultra-rapid metabolisers.
Maltese: Il-PRAC ikkonkluda wkoll li l-kodeina għandha tkun kontraindikata f'pazjenti pedjatriċi taħt it-18-il sena li tkun se ssirilhom tneħħija kirurġika tat-tunsilli u/jew adenojdektomija għal apnea ostruttiva waqt l-irqad kif ukoll f'nisa waqt li jkunu qed ireddgħu u f'pazjenti magħrufin li huma metabolizzaturi ultra-rapidi ta' CYP2D6.
English: A review of serious and fatal cases in paediatric patients from the literature, global pharmacovigilance databases and regulatory authorities suggests that the respiratory depressant effects of codeine may influence the occurrence of respiratory complications.
Maltese: Rieżami ta' każijiet serji u fatali f'pazjenti pedjatriċi mil-letteratura, mill-bażi tad-data globali ta' farmakoviġilanza u mill-awtoritajiet regolatorji jissuġġerixxi li l-effetti dipressanti respiratorji tal-kodeina jistgħu jinfluwenzaw l-okkorrenza ta' komplikazzjonijiet respiratorji.
English: • The PRAC having reviewed the available evidence and in particular the risk of serious adverse reactions of opioid toxicity in children, the nature of the condition and the views of clinical experts considered that the use of codeine containing medicinal products for the treatment of cough and/or cold in the paediatric population is not recommended.
Maltese: • Wara li qies l-evidenza disponibbli u b'mod partikolari r-riskju ta' reazzjonijiet avversi serji ta' tossiċità opjojdi fit-tfal, in-natura tal-kundizzjoni u l-fehmiet tal-esperti kliniċi, il-PRAC qies li lużu ta' prodotti mediċinali li fihom il-kodeina għall-kura ta' sogħla u/jew ta' riħ fil-popolazzjoni pedjatrika mhuwiex rakkomandat.
English: In addition, another randomised clinical trial (Taylor et al, 1993) in children with codeine, dextromethorphan as an active comparator, and a placebo group showed that neither codeine nor dextromethorphan were significantly better then placebo for the symptomatic treatment of cough in children under 12 years of age.
Maltese: Barra minn hekk, prova klinika randomizzata oħra (Taylor et al, 1993) fit-tfal bil-kodeina, b'dextromethorphan bħala komparatur attiv, u bi grupp ta' plaċebo wriet li la l-kodeina u lanqas dextromethorphan ma kienu ferm aħjar mill-plaċebo għall-kura sintomatiku ta' sogħla fit-tfal taħt it-12 sena.
English: The CMDh also considered that the risk of accidental overdose (four cases identified) could be minimised by the use of child resistant containers (CRC) for all oral liquid codeine containing medicinal products.
Maltese: Is-CMDh qies ukoll li r-riskju ta' doża eċċessiva aċċidentali (erba' każijiet identifikati) jista' jitnaqqas permezz tal-użu ta' kontenituri reżistenti għat-tfal (CRC) għall-prodotti mediċinali kollha li fihom ilkodeina f'forma likwida għall-użu orali.
English: The unpredictable and variable metabolism of codeine in children, governed by CYP2D6 polymorphism, may cause some children to exhibit morphine-related serious adverse events such as breathing difficulties or respiratory depression even within the recommended doses.
Maltese: Ilmetaboliżmu imprevedibbli u varjabbli tal-kodeina fit-tfal, irregolat mill-polimorfiżmu ta' CYP2D6, jista' jġiegħel lil xi tfal juru avvenimenti avversi serji relatati mal-morfina bħal diffikultà fit-teħid tan-nifs jew dipressjoni respiratorja anke fid-dożi rakkomandati.
English: The present referral under Article 31 of Directive 2001/83/EC concerns the use of codeine in paediatric patients for the cough and/or cold indications as triggered on 02 April 2014 by the German National Competent Authority (BfArM) due to the applicability of the above risk measures also to these indications.
Maltese: Ir-riferiment attwali skont l-Artikolu 31 tad-Direttiva 2001/83/KE jittratta l-użu tal-kodeina f'pazjenti pedjatriċi għall-indikazzjonijiet ta' sogħla u/jew ta' riħ kif inbeda fit-2 ta' April 2014 mill-Awtorità Nazzjonali Kompetenti Ġermaniża (BfArM) minħabba l-applikabbiltà tal-miżuri tar-riskji ta' hawn fuq għal dawn l-indikazzjonijiet ukoll.
English: • The PRAC, in line with the restrictions introduced during the codeine referral for pain relief in children, also concluded that all codeine containing medicinal products for the treatment of cough and/or cold should be contraindicated in women when breastfeeding, as well as in patients known to be CYP2D6 ultra-rapid metabolisers.
Maltese: • Il-PRAC, f'konformità mar-restrizzjonijiet introdotti waqt ir-riferiment tal-kodeina għal serħan mill-uġigħ fit-tfal, ikkonkluda wkoll li l-prodotti mediċinali kollha li fihom il-kodeina għall-kura ta' sogħla u/jew ta' riħ għandhom ikunu kontraindikati f'nisa waqt li jkunu qed ireddgħu, kif ukoll f'pazjenti magħrufin li huma metabolizzaturi ultrarapidi ta' CYP2D6.
English: The PRAC further considered that in children aged 12 years to 18 years for whom respiratory function might be compromised including those with neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures, codeine is not recommended as these conditions may worsen symptoms of morphine toxicity.
Maltese: Il-PRAC qies ukoll li fit-tfal ta' bejn it-12 sa 18-il sena li l-funzjoni respiratorja tagħhom tista' tkun kompromessa fosthom dawk b'disturbi newromuskolari, b'kundizzjonijiet kardijaċi jew respiratorji severi, b'infezzjonijiet fil-parti fil-parti respiratorja tan-naħa ta' fuq jew tal-pulmun, b'diversi trawmi jew bi proċeduri kirurġiċi estensivi, il-kodeina mhijiex rakkomandata peress li dawn ilkundizzjonijiet jistgħu jaggravaw is-sintomi ta' tossiċità minħabba l-morfina.
English: The PRAC also considered that the risk of accidental overdose (four cases identified) could be minimised by the use of child resistant containers (CRC).
Maltese: Il-PRAC qies ukoll li r-riskju ta' doża eċċessiva aċċidentali (erba' każijiet identifikati) jista' jitnaqqas permezz tal-użu ta' kontenituri reżistenti għat-tfal (CRC).
English: The PRAC also considered data from the European Pharmacovigilance database (Eudravigilance), a drug utilisation study of the patterns of prescription of codeine and performed a consultation with European healthcare professional organisations and with the Paediatric Committee (PDCO).
Maltese: Il-PRAC qies ukoll data mill-bażi tad-data tal-Farmakoviġilanza Ewropea (Eudravigilance), studju dwar l-użu tal-mediċina dwar ilmudelli ta' preskrizzjoni tal-kodeina u wettaq konsultazzjoni ma' organizzazzjonijiet professjonali Ewropej tal-kura tas-saħħa u mal-Kumitat Pedjatriku (PDCO).
English: Therefore, the PRAC recommends child resistant containers (CRC) for all oral liquid codeine containing medicinal products.
Maltese: Għalhekk, il-PRAC jirrakkomanda kontenituri reżistenti għat-tfal (CRC) għall-prodotti mediċinali kollha li fihom il-kodeina f'forma likwida għall-użu orali.
English: This included MAH responses, published literature data which became available since the initial granting of the marketing authorisations and consultation of healthcare professionals and other experts.
Maltese: Din kienet tinkludi t-tweġibiet tal-MAH, data minn letteratura ppubblikata li saret disponibbli millgħoti inizjali tal-awtorizzazzjonijiet għat-tqegħid fis-suq u konsultazzjoni mal-professjonisti talkura tas-saħħa u ma' esperti oħra
English: The symptoms of morphine toxicity may be increased in these settings.
Maltese: F'dawn is-sitwazzjonijiet is-sintomi ta' tossiċità minħabba l-morfina jistgħu jiżdiedu.
English: Treatment guidelines recommend treatment of persistent chronic cough in paediatric patients based on aetiology.
Maltese: Il-linji gwida ta' kura jirrakkomandaw li l-kura ta' sogħla kronika persistenti f'pazjenti pedjatriċi tkun abbażi tal-etjoloġija.
English: Similarly, it was not recommended to use codeine in children whose breathing could be compromised including children with neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
Maltese: Bl-istess mod, ma kienx rakkomandat li l-kodeina tintuża fit-tfal li n-nifs tagħhom jista' jkun kompromess fosthom tfal b'disturbi newromuskolari, b'kundizzjonijiet kardijaċi jew respiratorji severi, b'infezzjonijiet fil-parti fil-parti respiratorja tan-naħa ta' fuq jew tal-pulmun, b'diversi trawmi jew bi proċeduri kirurġiċi estensivi.
English: • The PRAC considered available data on the safety and the efficacy of the codeine containing medicinal products for the treatment of cough and/or cold in children in relation to the risk of opioid toxicity.
Maltese: • Il-PRAC qies id-data disponibbli dwar is-sigurtà u l-effikaċja tal-prodotti mediċinali li fihom ilkodeina għall-kura ta' sogħla u/jew ta' riħ fit-tfal fir-rigward tar-riskju ta' tossiċità opjojdi.
English: This included contraindication in patients of any age known to be CYP2D6 ultra-rapid metabolisers and in women of all ages who are breastfeeding.
Maltese: Dan kien jinkludi kontraindikazzjoni f'pazjenti ta' kwalunkwe età magħrufin li huma metabolizzaturi ultra-rapidi ta' CYP2D6 u f'nisa ta' kwalunkwe età li qed ireddgħu.
English: While acknowledging that uncertainties remain regarding the identification of particular paediatric populations at higher risk and the impact of age on codeine metabolism, the PRAC was of the opinion that neonates, toddlers and young children may be more vulnerable to opioid toxicity and therefore at special risk of life-threatening respiratory depression.
Maltese: Filwaqt li rrikonoxxa li għad fadal inċertezzi fir-rigward tal-identifikazzjoni ta' popolazzjonijiet pedjatriċi partikulari f'riskju ogħla u l-impatt tal-età fuq il-metaboliżmu tal-kodeina, il-PRAC kien tal-opinjoni li trabi tat-twelid, trabi li għadhom kemm telqu jimxu u tfal żgħar jistgħu jkunu aktar vulnerabbli għal tossiċità b'opjojdi u għalhekk qegħdin f'riskju speċjali ta' dipressjoni respiratorja ta' periklu għall-ħajja.
English: In total, fourteen reports of codeine intoxication in children related to the treatment of cough and respiratory infection were identified in the published literature.
Maltese: B'kollox, fil-letteratura ppubblikata ġew identifikati erbatax-il rapport ta' intossikazzjoni bil-kodeina fittfal relatati mal-kura ta' sogħla u ta' infezzjoni respiratorja.
English: The PRAC considered that children below 12 years are at special risk of life-threatening respiratory depression and therefore, contraindicated the use of codeine in children below 12 years.
Maltese: Il-PRAC qies li t-tfal taħt it-12-il sena huma f'riskju speċjali ta' dipressjoni respiratorja ta' periklu għall-ħajja u għalhekk, stabbilixxa li l-użu tal-kodeina huwa kontraindikat fit-tfal taħt it-12-il sena.