FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC considered the highly variable PK-profile of overdoses with MR paracetamol formulations, and the uncertainties related to the quantity and the formulation of the product that the patient has ingested, increase the challenges in effectively minimising the risk for paracetamol toxicity.
Maltese: • Il-PRAC ikkunsidra l-profil PK li jvarja ħafna ta' dożi eċċessivi b'formulazzjonijiet talparacetamol MR, u l-inċertezzi relatati mal-kwantità u mal-formulazzjoni tal-prodott li l-pazjent ikun inġesta, iż-żieda fl-isfidi sabiex ir-riskju ta' tossiċità bil-paracetamol jiġi minimizzat b'mod effettiv.
English: On 30 June 2016, Sweden triggered a procedure under Article 31 of Directive 2001/83/EC, and asked the PRAC to assess the impact of the above concerns on the benefit-risk balance of products with modified or prolonged release properties containing paracetamol and issue a recommendation on whether the marketing authorisation(s) of these products should be maintained, varied, suspended or revoked.
Maltese: Fit-30 ta' Ġunju 2016, l-Iżvezja tat bidu għal proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE u talbet lill-PRAC sabiex jivvaluta l-impatt tat-tħassib t'hawn fuq dwar il-bilanċ bejn il-benefiċċju u rriskju ta' prodotti b'karatteristiċi li jerħu l-mediċina b'mod modifikat jew prolungat li fihom ilparacetamol u sabiex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjoni(jiet) għat-tqegħid fis-suq ta' dawn il-prodotti għandhiex(għandhomx) tinżamm(jinżammu), tiġi(jiġu) varjata(i), sospiża(i) jew revokata(i).
English: The PRAC concluded that the treatment recommendations of overdoses based on standard paracetamol formulations, including use of the nomogram, are inadequate after intake of toxic doses of MR formulations.
Maltese: Il-PRAC ikkonkluda li rrakkomandazzjonijiet tal-kura tad-dożi eċċessivi bbażati fuq formulazzjonijiet standard talparacetamol, inkluż l-użu tan-nomogramma, mhumiex adegwati wara t-teħid ta' dożi tossiċi ta' formulazzjonijiet MR.
English: This translates into different PK profiles also at overdoses which is supported by available data including published case series.
Maltese: Dan isarraf fi profili PK differenti anki f'dożi eċċessivi li jiġu appoġġjati permezz ta' data disponibbli li tinkludi serje ta' każijiet ippubblikata.
English: Furthermore, the PRAC confirmed that despite the difference in the target population and the clinical settings, the fixed-dose combination of MR paracetamol/tramadol can result in overdoses that are severe in view of the risk of hepatotoxicity of paracetamol and the toxicity of tramadol (e.g. CNS effects including high risk of seizures, and renal failure).
Maltese: Barra minn dan, il-PRAC ikkonferma li minkejja d-differenza fil-grupp fil-mira u fis-sitwazzjonijiet kliniċi, il-kombinazzjoni ta' doża fissa tal-paracetamol/tat-tramadol MR tista' tirriżulta f'dożi eċċessivi li jkunu severi fid-dawl tar-riskju tal-epatossiċità tal-paracetamol u t-tossiċità tat-tramadol (eż. effetti tas-CNC li jinkludu riskju kbir ta' attakki ta' puplesija, u insuffiċjenza tal-kliewi).
English: The shortcomings of Rumack-Matthew nomogram have already been identified thus leading to different treatment protocols in case of co-ingestion of other products (particularly those who affect gastric motility) or in cases when no information can be obtained from the patients (e.g. time of ingestion is unknown).
Maltese: In-nuqqasijiet tan-nomogramma Rumack-Matthew diġà ġew identifikati, u b'hekk wasslu għal protokolli differenti ta' kura f'każ ta' koinġestjoni ta' prodotti oħrajn (b'mod partikolari dawk li jaffettwaw il-motilità gastrika) jew f'każijiet fejn l-ebda informazzjoni ma tkun tista' tinkiseb mill-pazjenti (eż. il-ħin tal-inġestjoni ma jkunx magħruf).
English: All MAHs proposed additional measures that would further minimise the risks associated with overdose with MR formulation for example updated package leaflet, communication to HCP (DHPC, education materials), prescription status, restriction of access to bottle packaging and large blister pack size for the patients.
Maltese: L-MAHs kollha pproponew miżuri addizzjonali li jkomplu jimminimizzaw ir-riskji assoċjati ma' doża eċċessiva b'formulazzjoni MR, pereżempju fuljett ta' tagħrif aġġornat, komunikazzjoni lil HCP (koproporfirja ereditarja) (DHPC, materjal edukattiv), l-istat tal-preskrizzjoni, ir-restrizzjoni tal-aċċess għall-imballaġġ fi fliexken u d-daqs kbir ta' pakkett blister għall-pazjenti.
English: An ad-hoc expert group meeting was held within this procedure with scientific and clinical experts in the management of poisoning.
Maltese: F'din il-proċedura saret laqgħa tal-grupp ta' esperti ad-hoc ma' esperti xjentifiċi u kliniċi fil-ġestjoni talavvelenament.
English: It was also noted that the FDA has recognised the dangers of the prescription combination of paracetamol and opioids and, in January 2014 implemented a fixed amount of paracetamol approved per dosage unit of combination.
Maltese: Ġie nnotat ukoll li l-FDA irrikonoxxiet il-perikli tal-preskrizzjoni tal-kombinazzjoni talparacetamol u tal-opjojdi u, f'Jannar 2014, din implimentat ammont fiss ta' paracetamol approvat għal kull unità ta' dożaġġ tal-kombinazzjoni.
English: • The PRAC also noted that in addition to the uncertainties on how to minimise the risk for paracetamol toxicity, the safety profile of tramadol was considered to present additional challenges for minimising the risks for toxicity (e.g. CNS effects, high-risk of seizures and renal failure) following an overdose with a prolonged release combination product of paracetamol and tramadol.
Maltese: • Il-PRAC innota wkoll li, minbarra l-inċertezzi dwar kif jiġi minimizzat ir-riskju ta' tossiċità bilparacetamol, il-profil tas-sikurezza tat-tramadol ġie kkunsidrat bħala li jippreżenta sfidi addizzjonali sabiex ir-riskji ta' tossiċità jiġu minimizzati (eż. effetti tas-CNS, riskju kbir ta' attakki ta' puplesija u insuffiċjenza tal-kliewi) wara doża eċċessiva bi prodott ikkombinat talparacetamol u tat-tramadol li jerħi l-mediċina b'mod prolungat.
English: Therefore, pursuant to Article 116 of Directive 2001/83/EC, the CMDh recommends the suspension of the marketing authorisations for products containing paracetamol, modified and prolonged release.
Maltese: Għalhekk, skont l-Artikolu 116 tad-Direttiva 2001/83/KE, is-CMDh jirrakkomanda s-sospensjoni talawtorizzazzjonijiet għat-tqegħid fis-suq tal-komunità għal prodotti li fihom il-paracetamol, li terħi lmediċina b'mod modifikat jew b'mod prolungat.
English: Out of these, six patients developed hepatotoxicity (ALT >1000 IU/L).
Maltese: Minn dawn, sitt pazjenti żviluppaw l-epatotossiċità (ALT >1000
English: During the re-examination a comparison of the effectiveness of revised treatment protocol to that of standard established treatment protocol used for the management of overdose with IR paracetamol in the prevention of paracetamol-related hepatotoxicity was made.
Maltese: Matul l-eżaminazzjoni mill-ġdid, sar paragun tal-effettività tal-protokoll tal-kura rivedut ma' dik talprotokoll tal-kura standard stabbilit li jintuża għall-ġestjoni ta' doża eċċessiva bil-paracetamol IR filprevenzjoni tal-epatossiċità relatata mal-paracetamol.
English: Paracetamol is the most commonly reported toxic ingestion of a medical substance in the UK and some other EEA countries (e.g. Sweden) and is the most common medicinal agent of intentional self-harm.
Maltese: Il-paracetamol hija l-aktar inġestjoni tossika ta' sustanza medika rrapportata b'mod komuni fir-Renju Unit u f'xi pajjiżi oħra taż-ŻEE (eż. l-Iżvezja) u hija l-aktar aġent mediċinali komuni ta' awtokorriment intenzjonat.
English: This was due to the safety profile of tramadol (e.g. convulsions, vomiting), which the group considered very likely to present additional challenges for handling an overdose with a prolonged release combination product of paracetamol and tramadol.
Maltese: Dan minħabba l-profil tas-sikurezza tat-tramadol (eż. konvulżjonijiet, remettar), li l-grupp ikkunsidra li kien hemm probabbiltà kbira li jippreżenta sfidi addizzjonali għallġestjoni ta' doża eċċessiva bi prodott ikkombinat tal-paracetamol u tat-tramadol li jerħi l-mediċina b'mod prolungat.
English: The PRAC considered the other risk minimisation measures proposed within the re-examination procedure (e.g. school programmes, restriction to pack type and size, educational materials and direct communication to HCPs) but concluded that these would neither be sufficient nor appropriate to adequately minimise the risk of intentional and unintentional overdose and consequential risk of hepatotoxicity.
Maltese: Il-PRAC ikkunsidra l-miżuri l-oħrajn tal-minimizzazzjoni tar-riskju proposti fil-proċedura tależaminazzjoni mill-ġdid (eż. programmi skolastiċi, restrizzjoni għat-tip u għad-daqs tal-pakkett, materjal edukattiv u komunikazzjoni diretta lill-HCPs), iżda kkonkluda li dawn la jkunu suffiċjenti biżżejjed u lanqas xierqa biżżejjed biex jimminimizzaw b'mod adegwat ir-riskju ta' doża eċċessiva intenzjonata u mhix intenzjonata u r-riskju konsegwenzjali tal-epatossiċità.
English: Further to the review of all data submitted related to the paracetamol MR and paracetamol/ tramadol MR products, in particular the risk of intentional and accidental overdoses related to their use, PRAC considered that the severe risk of hepatotoxicity related to overdoses, the complex PK profile of these products after an overdose, which makes the standard treatment protocol for paracetamol poisoning inadequate raises a serious risk to public health at Union level.
Maltese: Minbarra r-reviżjoni tad-data kollha ppreżentata relatata mal-paracetamol MR u ma' prodotti talparacetamol/tat-tramadol MR, b'mod partikolari r-riskju ta' dożi eċċessivi intenzjonati u aċċidentali relatati mal-użu tagħhom, il-PRAC ikkunsidra li r-riskju serju tal-epatossiċità relatata ma' dożi eċċessivi, il-profil PK kumpless ta' dawn il-prodotti wara doża eċċessiva, li jagħmel inadegwat ilprotokoll standard tal-kura għal avvelenament bil-paracetamol, iqajjem riskju serju għas-saħħa pubblika fil-livell tal-Unjoni.
English: However, study by Carroll and colleagues (2015) that investigated the influence of the change to UK overdose treatment guidelines showed that a proportion of patients is already being treated on a case by case basis, independently of existing UK treatment guidelines.
Maltese: Madankollu, studju minn Carroll u kollegi (2015) li investiga l-influwenza tal-bidla għal-linji gwida tar-Renju Unit dwar il-kura ta' doża eċċessiva wera li proporzjon ta' pazjenti diġà qegħdin jiġu kkurati fuq bażi ta' każ b'każ, indipendentement mil-linji gwida eżistenti tar-Renju Unit dwar il-kura.
English: The Rumack-Matthew nomogram was developed for single overdose with precise time of ingestion and cannot accurately assess risk after repeated overdoses, acute overdose of a sustained-release product, or when the time of ingestion is unknown or patients present beyond 24 hours.
Maltese: In-nomogramma Rumack-Matthew ġiet żviluppata għal doża eċċessiva waħda bil-ħin preċiż talinġestjoni u ma tistax tivvaluta b'mod preċiż ir-riskju wara dożi eċċessivi ripetuti, doża eċċessiva akuta ta' prodott li jerħi l-mediċina b'mod sostnut, jew meta l-ħin tal-inġestjoni ma jkunx magħruf jew il-ħin li jippreżentaw il-pazjenti jkun jaqbeż 24 siegħa.
English: Protocol based on a systematic treatment with NAC would also lead to a number of patients unnecessarily being treated or over-treated with NAC which is not proportionate and acceptable in view of the adverse reactions cutaneous like rash, itching, flushing and gastrointestinal like nausea, vomiting) associated with treatment with NAC.
Maltese: Protokoll ibbażat fuq kura sistematika bin-NAC iwassal għal numru ta' pazjenti li jiġu kkurati mingħajr bżonn jew li jiġu kkurati żżejjed bin-NAC, li ma jkunx proporzjonat u aċċettabbli fid-dawl tar-reazzjonijiet avversi kutanji (bħal raxx, ħakk, ħmura u dardir kważi gastrointestinali, remettar) assoċjati mal-kura bin-NAC.
English: The experts were of the same views as the PRAC regarding the complications both in assessment and treatment of poisoning by paracetamol MR and the subsequent related potential for severe harm and this is due to the unpredictable release profile of MR paracetamol, the PK profile and the difficulty in establishing and implementing an optimal treatment protocol MR paracetamol poisoning is associated with additional complications.
Maltese: L-esperti kellhom l-istess opinjonijiet bħall-PRAC fir-rigward tal-kumplikazzjonijiet kemm fil-valutazzjoni kif ukoll fil-kura tal-avvelenament bil-paracetamol MR u l-potenzjal sussegwenti relatat ma' korriment serju u dan minħabba li l-profil tar-rilaxx imprevedibbli tal-paracetamol MR, ilprofil PK u d-diffikultà fl-istabbiliment u fl-implimentazzjoni ta' protokoll ottimali tal-kura ta' avvelenament bil-paracetamol MR huma assoċjati ma' kumplikazzjonijiet addizzjonali.
English: It is considered that the serious and potentially fatal hepatic injury in case of overdose with paracetamol MR and paracetamol/tramadol MR formulations cannot be sufficiently minimised by effective risk minimisation measures to prevent this risk and to manage it once it occurs.
Maltese: Huwa kkunsidrat li l-korriment epatiku serju u potenzjalment fatali fil-każ ta' doża eċċessiva bilparacetamol MR u b'formulazzjonijiet MR tal-paracetamol/tat-tramadol ma jistgħux jiġu minimizzati b'mod suffiċjenti permezz ta' attivitajiet tal-minimizzar tar-riskju effettivi li jipprevjenu dan ir-riskju u li jimmaniġġjawh ladarba jseħħ.
English: The PRAC acknowledged the need for a better characterisation of the risk (relationship with the dose, the concentrations and the toxicity) as well as the need to address uncertainties on the handling of patients with MR paracetamol products overdose (e.g. the appropriate threshold to start NAC administration, the dose and duration of NAC treatment as well as the optimal number of paracetamol concentration that need to be determined).
Maltese: Il-PRAC irrikonoxxa l-ħtieġa għal karatterizzazzjoni aħjar tar-riskju (relazzjoni mad-doża, ilkonċentrazzjonijiet u t-tossiċità), kif ukoll il-ħtieġa li jiġu indirizzati l-inċertezzi dwar il-ġestjoni talpazjenti b'doża eċċessiva ta' prodotti tal-paracetamol MR (eż. il-limitu xieraq biex tinbeda amministrazzjoni tan-NAC, id-doża u t-tul ta' żmien tal-kura tan-NAC kif ukoll in-numru ideali ta' konċentrazzjoni tal-paracetamol li jeħtieġ li jiġu ddeterminati).
English: • The PRAC reviewed all the available data submitted with regard to overdose of the paracetamol containing MR products, including intentional and accidental overdose.
Maltese: • Il-PRAC irreveda d-data kollha disponibbli li ġiet ippreżentata fir-rigward ta' doża eċċessiva ta' prodotti MR li fihom il-paracetamol, inkluża doża eċċessiva intenzjonata u aċċidentali.
English: Tramadol/paracetamol MR tablets are indicated for treatment of moderate and severe pain conditions.
Maltese: Pilloli tat-tramadol/talparacetamol MR jiġu indikati għall-kura ta' kundizzjonijiet ta' wġigħ moderat u serju.
English: For the suspension of products containing paracetamol, modified and prolonged release to be lifted, the marketing authorisation holders shall provide evidence in support of proportionate, feasible and effective measures to prevent the risk of overdose and minimise the risk of hepatic injury following intentional or accidental overdoses with modified release paracetamol containing products.
Maltese: Sabiex titneħħa s-sospensjoni ta' prodotti li fihom il-paracetamol, li terħi l-mediċina b'mod modifikat u prolungat, id-detenturi tal-awtorizzazzjoni għat-tqegħid fuq is-suq għandhom jipprovdu evidenza li tappoġġja miżuri proporzjonati, fattibbli u effettivi għall-prevenzjoni tar-riskju ta' doża eċċessiva u sabiex jiġi minimizzat ir-riskju ta' korriment epatiku wara dożi eċċessivi intenzjonati jew aċċidentali bi prodotti li fihom il-paracetamol li terħi l-mediċina b'mod modifikat.
English: Products with modified or prolonged release properties containing paracetamol, which are intended to have a longer action, are available in several EU Member States.
Maltese: Prodotti b'karatteristiċi li jerħu l-mediċina b'mod modifikat jew prolungat li fihom il-paracetamol, li huma maħsuba li jkollhom azzjoni fit-tul, huma disponibbli f'diversi Stati Membri tal-UE.
English: The measures to improve the awareness on the risk of overdose (educational material, product information, labelling, DHPC) was not considered effective to prevent case of overdose, especially when intentional, as information to the patients and healthcare professionals is already extensive.
Maltese: Il-miżuri sabiex titjieb is-sensibilizzazzjoni dwar ir-riskju ta' doża eċċessiva (materjal edukattiv, informazzjoni dwar il-prodott, tikkettar, DHPC) ma tqisux bħala effettivi biex jipprevjenu każijiet ta' doża eċċessiva, speċjalment meta din tkun intenzjonata, peress li l-informazzjoni għall-pazjenti u għall-professjonisti tal-kura tas-saħħa diġà hija estensiva.
English: In conclusion, the complex PK profile after an overdose of paracetamol MR containing medicinal products, and the fact that the standard treatment protocol for paracetamol poisoning is inadequate for these products and the severe risk of hepatotoxicity related to overdose with paracetamol raises a serious risk to public health at Union level.
Maltese: Fl-aħħar nett, il-profil PK kumpless wara doża eċċessiva ta' prodotti mediċinali li jkun fihom paracetamol MR, u l-fatt li l-protokoll tal-kura standard għal avvelenament bil-paracetamol mhuwiex adegwat għal dawn il-prodotti u għar-riskju serju tal-epatossiċità relatat ma' doża eċċessiva bilparacetamol, iqajjem riskju serju dwar is-saħħa pubblika fil-livell tal-Unjoni.
English: Further, the feasibility of determining and implementing effective measures across EU Member States is questioned, due to the complexity of managing two specific protocols, a close monitoring (increased blood sampling) and the complexity due to the uncertainty on the ingested formulation that is prejudicial to the patient in view of the risk of not using an effective protocol and the safety concern related to the unnecessary administration of NAC.
Maltese: Barra minn dan, il-fattibbiltà tad-determinazzjoni u l-implimentazzjoni ta' miżuri effettivi fl-Istati Membri tal-UE titpoġġa f'dubju, minħabba l-kumplessità tal-ġestjoni ta' żewġ protokolli speċifiċi, monitoraġġ mill-qrib (kampjunar tad-demm miżjud) u l-kumplessità minħabba l-inċertezza fuq ilformulazzjoni li tkun ġiet inġestita li tkun ta' ħsara lill-pazjent fid-dawl tar-riskju li ma jintużax protokoll effettiv u t-tħassib dwar is-sikurezza relatat mal-amministrazzjoni mhux meħtieġa tan-NAC.
English: This included the responses submitted by the marketing authorisation holders (MAHs) in writing and during oral explanations, the grounds for the re-examination as submitted by the two concerned MAHs, as well as the advice from the two groups of experts in the management of poisoning, pain management and pharmacokinetics, published studies and spontaneous reports of overdose.
Maltese: Dan inkluda r-risposti ppreżentati mid-detenturi tal-awtorizzazzjoni għat-tqegħid fuq is-suq (MAHs) fl-ispjegazzjonijiet orali u bil-miktub, ir-raġunijiet għall-eżaminazzjoni mill-ġdid kif ippreżentata miż-żewġ MAHs ikkonċernati, kif ukoll il-parir miż-żewġ gruppi ta' esperti fil-ġestjoni talavvelenament, fil-ġestjoni tal-uġigħ u fil-farmakokinetika, studji ppubblikati u rapporti spontanji ta' doża eċċessiva.
English: Inherent PK characteristics of these MR products; with one part of the paracetamol content being released immediately, and one (larger) part with a delayed release, differ from the immediate release (IR) formulations.
Maltese: Il-karatteristiċi PK inerenti ta' dawn il-prodotti MR; fejn parti waħda tal-kontenut talparacetamol tintreħa b'mod immedjat, u parti waħda (akbar) tintreħa b'mod ittardjat, ivarjaw mirformulazzjonijiet ta' rilaxx immedjat (IR).
English: It is not considered that this safety concern of serious and potentially fatal hepatic injury in case of overdose with paracetamol MR formulations is sufficiently minimised by effective risk minimisation measures to prevent this risk and to manage it once it occurs.
Maltese: Dan it-tħassib dwar issikurezza ta' korriment epatiku serju u potenzjalment fatali fil-każ ta' doża eċċessiva b'formulazzjonijiet MR tal-paracetamol ma jitqiesx li huwa minimizzat b'mod suffiċjenti permezz ta' attivitajiet tal-minimizzar tar-riskju effettivi li jipprevjenu dan ir-riskju u li jimmaniġġjawh ladarba jseħħ.
English: The measurement of the effectiveness of a modified model or new guidelines for treatment of MR paracetamol overdose was discussed by the second ad-hoc expert group, however the sample size (100 patients) was not considered sufficient.
Maltese: Il-kejl tal-effikaċja ta' mudell modifikat jew ta' linji gwida ġodda għall-kura ta' doża eċċessiva tal-paracetamol MR ġie diskuss mit-tieni grupp ta' esperti ad-hoc, madankollu d-daqs tal-kampjun (100 pazjent) ma ġiex ikkunsidrat bħala suffiċjenti.
English: It has to also be taken into account that there could be a subgroup of tramadol abusers in which risk of suicidality is different.
Maltese: Għandu jiġi kkunsidrat ukoll li jista' jkun hemm sottogrupp ta' persuni li jabbużaw mit-tramadol li fih ir-riskju ta' suwiċidju jkun differenti.
English: The PRAC agreed with the outcome of an ad-hoc expert group meeting convened during the reexamination, where the experts concluded that it is not possible to extrapolate from a PK model developed for paracetamol as a single ingredient to the combination of paracetamol/tramadol.
Maltese: Il-PRAC qabel mar-riżultat tal-laqgħa tal-grupp ta' esperti ad-hoc li saret matul l-eżaminazzjoni millġdid, fejn l-esperti kkonkludew li mhuwiex possibbli li minn mudell PK żviluppat għall-paracetamol jiġi estrapolat bħala ingredjent wieħed għall-kombinazzjoni tal-paracetamol/tat-tramadol.
English: Although it was recognised that repeated, and patient-tailored plasma sampling for determination of paracetamol levels and liver enzymes together with tailored administration of NAC may be sufficient to avoid serious hepatic damage, if the patient presents to the medical emergency unit in time, it is currently not possible to determine an effective and proportionate overdose protocol for such overdose due to lack of evidence.
Maltese: Ir-restrizzjoni tad-daqs tal-pakkett, filwaqt li ma tiċħad l-ebda effett, ma tillimitax b'mod suffiċjenti l-aċċess għal dawn il-prodotti mediċinali u aktarx ma tipprevjenix doża eċċessiva, b'mod partikolari dawk intenzjonati.
English: To lift the suspension, the PRAC recommended that the MAHs should provide evidence of proportionate, feasible and effective measures to minimise the risk for hepatic injury following intentional or accidental overdoses with modified release paracetamol containing products.
Maltese: Sabiex titneħħa s-sospensjoni, il-PRAC irrakkomanda li l-MAHs għandhom jipprovdu evidenza ta' miżuri proporzjonati, fattibbli u effettivi sabiex jiġi minimizzat ir-riskju ta' korriment epatiku wara dożi eċċessivi intenzjonati jew aċċidentali bi prodotti li fihom il-paracetamol li terħi l-mediċina b'mod modifikat.
English: The high variability in PK-profile of an overdose with a MR paracetamol containing product, and the continuously present uncertainties related to what formulation (IR or MR paracetamol) and the dose the patient has ingested, leads to serious safety concern in managing paracetamol overdoses.
Maltese: Il-varjabbiltà għolja fil-profil PK ta' doża eċċessiva fi prodott li jkun fih il-paracetamol MR, u l-inċertezzi kontinwi preżenti relatati ma' liema formulazzjoni (paracetamol IR jew MR) u d-doża li l-pazjent ikun bela' jwasslu għal tħassib serju għas-sikurezza fil-ġestjoni ta' dożi eċċessivi tal-paracetamol.