FrancophonIA/ELRC3.0 huggingface dataset:
English: 3 Bradycardia, sometimes accompanied by orthostatic hypotension, has occurred in healthy volunteers at doses of Flolan greater than 5 nanograms/kg/min.
Maltese: 3 Bradikardija, xi kultant msieħba ma' pressjoni baxxa mal-waqqaf, seħħet f'voluntiera f'saħħithom b'dożi ta' Flolan ta' aktar minn 5 nanogrammi/kg/min.
English: The liquid does not contain a preservative.
Maltese: Illikkwidu ma fihx preservattiv.
English: 0.5 mg vial powder for solution for infusion, 1 vial of solvent and 1 filter unit 0.5 mg vial powder for solution for infusion, 2 vials of solvent and 1 filter unit
Maltese: Kunjett ta' trab ta' 0.5 mg għal soluzzjoni għall-infużjoni, kunjett 1 ta' solvent u komponent 1 biex jiffiltra Kunjett ta' trab ta' 0.5 mg għal soluzzjoni għall-infużjoni, 2 kunjetti ta' solvent u komponent 1 biex jiffiltra
English: Higher circulating doses of epoprostenol (20 nanograms/kg/min) disperse circulating platelet aggregates and increase by up to two fold the cutaneous bleeding time.
Maltese: Dożi ogħla ta' epoprostenol (20 nanogramma/kg/min) li jiċċirkulaw iferrxu aggregati tal-plejtlits li jiċċirkulaw u jżidu il-ħin tal-ħruġ tad-demm kutanju sa darbtejn aktar.
English: 1.5 mg vial powder for solution for infusion, 1 vial of solvent and 1 filter unit 1.5 mg vial powder for solution for infusion, 2 vials of solvent and 1 filter unit
Maltese: Kunjett ta' trab ta' 1.5 mg għal soluzzjoni għall-infużjoni, kunjett 1 ta' solvent u komponent 1 biex jiffiltra Kunjett ta' trab ta' 1.5 mg għal soluzzjoni għall-infużjoni, 2 kunjetti ta' solvent u komponent 1 biex jiffiltra
English: Breast-feeding should be discontinued during treatment with Flolan.
Maltese: It-treddigħ għandu jitwaqqaf waqt it-trattament bi Flolan.
English: • increase in sugar (glucose) in the blood
Maltese: • żieda fiz-zokkor (glucose) fid-demm
English: Sodium chloride 0.9% w/v solution must not be used when Flolan is to be used for the treatment of pulmonary arterial hypertension.
Maltese: Soluzzjoni ta' sodium chloride 0.9% w/v m'għandhiex tintuża meta Flolan ikun se jingħata għall-kura ta' pressjoni għolja fl-arterji tal-pulmun.
English: INFORMATION FOR HEALTHCARE PROFESSIONALS
Maltese: INFORMAZZJONI GĦALL-PROFESSJONISTI
English: Only the 0.5 mg pack is suitable for use in renal dialysis.
Maltese: Dijalisi tal-Kliewi Il-pakkett ta' 0.5 mg biss huwa adattat biex jintuża fid-dijalisi tal-kliewi.
English: Reconstituted solutions must not be administered over more than 12 hours when they are used at room temperature (between 15°C and 25°C).
Maltese: Soluzzjonijiet irrikostitwiti m'għandhomx jingħataw fuq perjodu itwal minn 12-il siegħa meta jintużaw f'temperatura tal-kamra (bejn 15-il°C u 25°C).
English: An abrupt interruption of therapy can induce a rebound of pulmonary arterial hypertension resulting in dizziness, asthenia, increase dyspnoea, and may lead to death (see section 4.2).
Maltese: Interruzzjoni f'daqqa tat-terapija tista' terġa' tikkaġuna pressjoni għolja fl-arterja tal-pulmun li twassal għal sturdament, astenja, żieda fil-qtugħ ta' nifs, u tista' twassal għall-mewt (ara sezzjoni 4.2).
English: Flow rates in mL/h b. Diluted: A commonly used dilution is:
Maltese: Iddilwit: Dilwizzjoni li tintuża b'mod komuni hija:
English: It is possible to refrigerate Flolan reconstituted solutions, before they are used at room temperature, ranging between 2°C and 8°C and without exceeding 40 hour storage.
Maltese: Huwa possibbli li tpoġġi soluzzjonijet rikostitwiti ta' Flolan fil-friġġ, qabel ma' dawn jintużaw f'temperatura tal-kamra, f'temperatura li tvarja bejn 2°C u 8°C u mingħajr ma jinqabżu 40 siegħa ta' ħażna.
English: Visible clotting (not necessitating intervention) was reported in another 31% of epoprostenol dialyses and 5% of heparin dialyses.
Maltese: Tagħqid tad-demm li jidher (li ma kienx jeħtieġ intervent) ġie rrappurtat f'31% oħra ta' dijalisi b'epoprostenol u f'5% oħra ta' dijalisi b'heparin.
English: Keep dry.
Maltese: Tqala u treddigħ
English: If you are being given Flolan using an infusion pump, a ‘cold pouch' may be used to maintain the temperature of the solution.
Maltese: Jekk qed tingħata Flolan permezz ta' pompa tal-infużjoni, tista' tintuża ‘borża kiesħa' biex tinżamm it-temperatura tassoluzzjoni.
English: How to take Flolan
Maltese: X'fih Flolan
English: Flolan contains the active substance epoprostenol which belongs to a group of medicines called prostaglandin, which stops blood from clotting and widens the blood vessels.
Maltese: Flolan fih is-sustanza attiva epoprostenol li tagħmel parti minn grupp ta' mediċini msejħa prostaglandin, li jwaqqaf d-demm milli jagħqad u jwessa' l-kanali tad-demm.
English: • 10,000 nanogram/mL - Two vials containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
Maltese: • 10,000 nanogramma/mL - Żewġ kunjetti li fihom 0.5 mg ta' Flolan irrikostitwit u ddilwit fis-solvent għall-volum totali ta' 100 mL.
English: Independent of technical difficulties which occurred rarely with either treatment, major dialysis-limiting clotting did not occur in 93% of all epoprostenol dialyses and 99% of all heparin dialyses.
Maltese: Meta wieħed ma jqisx id-diffikultajiet tekniċi li seħħew b'mod rari b'kull waħda miż-żewġ kuri, tagħqid taddemm kbir li jillimita d-dijalisi ma seħħx f'93% tad-dijalisi kollha b'epoprostenol u f'99% tad-dijalisi kollha b'heparin.
English: 4.5 Interaction with other medicinal products and other forms of interaction When Flolan is administered to patients receiving concomitant anticoagulants standard anticoagulant monitoring is advisable.
Maltese: Meta Flolan jingħata lill-pazjenti li qed jirċievu antikoagulanti oħra fl-istess ħin, huwa rrakkomandat monitoraġġ standard tal-antikoagulanti.
English: To establish that renal dialysis patients at increased risk of haemorrhage bleed less frequently with epoprostenol than heparin, 2 major prospectively controlled studies were conducted.
Maltese: Biex jiġi stabbilit li pazjenti fuq dijalisi tal-kliewi li qegħdin f'riskju akbar ta' emorraġija ikollhom ħruġ ta' demm anqas frekwenti b'epoprostenol milli b'heparin, saru 2 studji kbar ikkontrollati b'mod prospettiv.
English: Severity of bleeding in those patients was improved more frequently with epoprostenol the day prior to dialysis and on dialysis day (predialysis: N=4/8; dialysis: N=6/16) than with heparin (predialysis: N=4/13; dialysis:
Maltese: Ilqawwa tal-ħruġ tad-demm f'dawk il-pazjenti tjiebet b'mod aktar frekwenti b'epoprostenol fil-jum ta' qabel id-dijalisi u fil-jum tad-dijalisi (qabel id-dijalisi: N=4/8; dijalisi: N=6/16) milli b'heparin (qabel id-dijalisi: N=4/13; dijalisi: N=4/25).
English: The hypotensive effect of Flolan may be enhanced by the use of acetate buffer in the dialysis bath during renal dialysis.
Maltese: Is-solvent ipprovdut biss jista' jintuża għal aktar dilwizzjoni ta' Flolan irrikostitwit.
English: A risk to the breastfeeding child cannot be excluded.
Maltese: Irriskju gћat-trabi tat-twelid mhux eskluż.
English: The median baseline value for the conventional therapy group and epoprostenol plus conventional therapy group was 240 meters and 270 meters, respectively.
Maltese: L-iskop finali primarju taleffikaċja tal-istudju kien titjib fis-6MWT. Il-valur medjan fil-linja bażi għall-grupp ta' terapija konvenzjonali u l-grupp ta' epoprostenol mogħti flimkien ma' terapija konvenzjonali kien ta' 240 metru u 270 metru, rispettivament.
English: Elevated cAMP levels regulate intracellular calcium concentrations by stimulating calcium removal, and thus platelet aggregation is ultimately inhibited by the reduction of cytoplasmic calcium, upon which platelet shape change, aggregation and the release reaction depends.
Maltese: Livelli għolja ta' cAMP jirregolaw il-konċentrazzjonijiet intraċellulari tal-kalċju billi jistimulaw it-tneħħija tal-kalċju, u b'hekk fl-aħħarnett l-aggregazzjoni tal-plejtlits tkun impedita permezz ta' tnaqqis fil-kalċju taċ-ċitoplażma, li fuqu jiddependu t-tibdil tal-forma, l-aggregazzjoni u r-reazzjoni ta' ħelsien tal-plejtlits.
English: This leaflet was last revised in {MM/YYYY}.
Maltese: Dan jista' jkun segwit bi nfafet u taqxir tal-ġilda.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON box for powder vials and solvent vials:
Maltese: Hemm pakkett wieħed biss disponibbl biex jintuża fid-dijalisi tal-kliewi:
English: Flolan 0.5 mg powder for solution for infusion Flolan 1.5 mg powder for solution for infusion Intravenous use
Maltese: Flolan 0.5 mg Trab u Solvent għal Soluzzjoni għall-Infużjoni Flolan 1.5 mg Trab u Solvent għal Soluzzjoni għall-Infużjoni
English: If the initial infusion rate of 2 nanograms/kg/min is not tolerated, a lower dose which is tolerated by the patient should be identified.
Maltese: Jekk ir-rata tal-bidu ta' 2 nanogrammi/kg/min ma tkunx ittollerata, għandha tiġi identifikata doża aktar baxxa li hija ttollerata mill-pazjent.
English: The safety and efficacy of epoprostenol in children younger than 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' epoprostenol fi tfal li għandhom anqas minn 18-il sena ma ġewx determinati s'issa.
English: Adverse events are listed below by system organ class and frequency.
Maltese: Il-każijiet avversi huma elenkati hawn taħt skont il-klassi tas-sistemi u tal-organi u l-frekwenza.
English: Freshly prepared epoprostenol solutions for the treatment of pulmonary arterial hypertension should be used within 12 hours at 25°C, or stored for up to 40 hours at between 2 to 8°C and then used within 8 hours at
Maltese: Soluzzjonijiet ta' epoprostenol ippreparati friski għall-kura ta' pressjoni għolja fl-arterji tal-pulmun għandhom jintużaw fi żmien 12-il siegħa f'temperatura ta' 25°C, jew jinħażnu għal 40 siegħa f'temperatura bejn 2 u 8°C u imbagħad jintużaw fi żmien 8 sigħat f'temperatura ta' 25°C.
English: Brestfeeding
Maltese: Treddigħ
English: Powder for solution for infusion: Mannitol
Maltese: Formuli tar-rati tal-infużjoni - eżempji
English: Increases in exercise capacity were accompanied by statistically significant improvements in dyspnoea, as measured by the Borg Dyspnea Index.
Maltese: Żidiet fil-ħila għall-eżerċizzju kienu akkumpanjati minn itjib sinifikanti b'mod statistiku fil-qtugħ ta' nifs, kif imkejjel permezz tal-Indiċi talQtugħ ta' nifs Borg (Borg Dyspnea Index).
English: General Disorders and Administration Site Conditions Very common Pain (unspecified) Common
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna Uġigħ (mhux speċidfikat) Komuni
English: Skin and Subcutaneous Tissue Disorders Common
Maltese: FIS-SUQ [Biex timtela mill-pajjiż partikolari]
English: Pregnancy and breast-feeding
Maltese: • infezzjoni fis-sit tal-injezzjoni
English: This medicinal product contains sodium, which should be taken into consideration by patients on a controlled sodium diet.
Maltese: Dan il-prodott mediċinali fih sodium, li għandu jitqies minn pazjenti li qegħdin fuq dieta b'ammont ikkontrollat ta' sodium.
English: T. 2018 Apr;43(4):191-248.
Maltese: Apr;43(4):191-248.
English: 2 Grissinger M. Severe Harm and Death Associated With Errors and Drug Interactions Involving Low-Dose Methotrexate.
Maltese: Severe Harm and Death Associated With Errors and Drug Interactions Involving Low-Dose Methotrexate.
English: Systematic review by Saedder and colleagues (2014)1 revealed that 47% of all serious medication errors were caused by only seven drug classes, with methotrexate topping the list in percentage of incidents.
Maltese: Ir-rieżami sistematiku minn Saedder and colleagues (2014)1 żvela li 47 % tal-iżbalji serji kollha fil-medikazzjoni kienu kkawżati minn seba' klassijiet ta' mediċini biss, b'methotrexate fuq quddiem nett tal-lista f'perċentwali ta' inċidenti.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for medicinal products containing methotrexate;
Maltese: • Il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal prodotti mediċinali li fihom methotrexate;
English: The PRAC adopted a recommendation on 11 July 2019 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Il-PRAC adotta rakkomandazzjoni fil-11 ta' Lulju 2019 li mbagħad ġiet ikkunsidrata mis-CHMP, skont lArtikolu 107k tad-Direttiva 2001/83/KE.
English: It is indicated in the treatment of cancers such as acute lymphoblastic leukaemia (ALL) and various inflammatory conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, and psoriatic arthritis and as steroid sparing adjunctive therapy in Crohn's disease.
Maltese: Huwa indikat fit-trattament tal-kanċers bħalma huma l-lewkimja limfoblastika akuta (ALL) kif ukoll diversi kundizzjonijiet infjammatorji, inklużi l-artrite rewmatika, l-artrite idjopatika ġuvenili, il-psorijażi, u l-artrite psorjatika u bħala terapija aġġuntiva li tiskarta l-użu tal-isterojdi fil-marda ta' Crohn.
English: Furthermore, of the 74 articles that met the review's inclusion criteria, 73 contained information about a serious adverse reaction caused by methotrexate-related medication error (found in the FDA Adverse Event Reporting System).
Maltese: Barra minn hekk, mill-74 artikolu li ssodisfaw il-kriterji ta' inklużjoni tar-rieżami, 73 kien fihom informazzjoni dwar reazzjoni avversa serja kkawżata minn żball fil-medikazzjoni relatat ma' methotrexate (misjuba fis-Sistema ta' Rapportar ta' Avvenimenti Avversi tal-FDA).
English: Since early 1996, harmful or fatal errors with low dose oral methotrexate have been reported to the Institute for Safe Medication Practices (ISMP) and published in more than 50 of its newsletters, but in spite of this and numerous risk minimization measures, methotrexate continues to be subject in documented serious medication errors (Grissinger, 20182).
Maltese: minimizzazzjoni tar-riskju, methotrexate jkompli jkun soġġett fi żbalji serji fil-medikazzjoni ddokumentati (Grissinger, 20182).
English: In order to assess the root causes and the impact of the risk of medication errors due to inadvertent daily dosing instead of weekly dosing, the PRAC considered the analyses of cases report of inadvertent daily instead of weekly usage of methotrexate-containing products, including reports without adverse events, for the period 1 January 2013 until 31 March 2018 from the EudraVigilance database as well as from the data provided by the MAHs of methotrexate-containing products which included analyses of the medication error case reports from the companies' pharmacovigilance databases and in the literature.
Maltese: Sabiex jiġu vvalutati l-kawżi ewlenin u l-impatt tar-riskju ta' żbalji fil-medikazzjoni minħabba dożaġġ b'mod mhux intenzjonat ta' kuljum minflok ta' kull ġimgħa, il-PRAC ikkunsidra lanaliżi tar-rapport ta' każijiet ta' prodotti li fihom methotrexate b'użu, b'mod mhux intenzjonat, kuljum minflok kull ġimgħa, inklużi rapporti mingħajr avvenimenti avversi, għall-perjodu mill1 ta' Jannar 2013 sal-31 ta' Marzu 2018 mill-bażi tad-data EudraVigilance, kif ukoll mid-data pprovduta mill-MAHs ta' prodotti li fihom methotrexate li kienet tinkludi analiżi tar-rapporti tal-każijiet ta' żbalji fil-medikazzjoni mill-bażijiet ta' data tal-farmakoviġilanza tal-kumpaniji, kif ukoll fil-letteratura.
English: On 22 March 2018 Spain therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the root causes and the impact of the risk of medication errors on the benefit-risk balance of oral formulation of methotrexate and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Għalhekk, fit-22 ta' Marzu 2018, Spanja tat bidu għal riferiment skont l-Artikolu 31 tadDirettiva 2001/83/KE bħala riżultat ta' data tal-farmakoviġilanza, u talbet lill-PRAC biex jivvaluta lkawżi ewlenin u l-impatt tar-riskju ta' żbalji fil-medikazzjoni fuq il-bilanċ bejn il-benefiċċju u r-riskju ta' formulazzjoni orali ta' methotrexate u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq rilevanti għandhomx jinżammu, jiġu varjati, sospiżi jew revokati.
English: To increase awareness and remind healthcare professionals and patients of the weekly dosing schedule required for the treatment of some conditions, the MAHs for oral methotrexate-containing products with at least an indication requiring dosing once a week had been requested, as outcome of the PSUSA (EMEA/H/C/PSUSA/00002014/201706), to implement a visual reminder on the outer and immediate packaging to warn patients to take the product once a week for those indications requiring dosing once a week.
Maltese: fihom methotrexate li fihom tal-inqas indikazzjoni li teħtieġ dożaġġ darba fil-ġimgħa kienu mitluba, bħala riżultat tal-PSUSA (EMEA/H/C/PSUSA/00002014/201706), biex jimplimentaw tfakkira viżwali fuq in-naħa ta' barra u li tmiss mal-imballaġġ, biex twissi lill-pazjenti biex jieħdu l-prodott darba fil-ġimgħa għal dawk l-indikazzjonijiet li jeħtieġu dożaġġ darba fil-ġimgħa.
English: Each group of indications has a different administration schedule:
Maltese: Kull grupp ta' indikazzjonijiet għandu skeda ta' għoti differenti:
English: • For the treatment of cancer, various administration schedules including daily dosage may be used;
Maltese: • Għat-trattament tal-kanċer, jistgħu jintużaw diversi skedi amministrattivi li jinkludu dożaġġ ta' kuljum;
English: • The PRAC considered the totality of the data submitted for methotrexate-containing products with regard to the important identified risk of medication errors when methotrexate intended for once weekly use is taken daily by mistake, the root causes for this risk and the effectiveness of the risk minimisation measures in place.
Maltese: • Il-PRAC ikkunsidra t-totalità tad-data ppreżentata għal prodotti li fihom methotrexate firrigward tar-riskju ta' importanza identifikat ta' żbalji fil-medikazzjoni meta methotrexate intiż li jittieħed darba fil-ġimgħa jittieħed kuljum b'mod mhux intenzjonat, il-kawżi ewlenin għal dan ir-riskju u l-effettività tal-miżuri fis-seħħ ta' minimizzazzjoni tar-riskju.
English: The risk of medication errors due to inadvertent daily instead of once weekly dosing is an important identified risk and all methotrexate-containing products for which additional risk minimisation measures are required to address this risk (i.e. replacement of bottles/tubes by blisters, implementation of educational material and patient card), should have a risk management plan (RMP) in place listing all pharmacovigilance activities and risk minimisation measures agreed.
Maltese: Ir-riskju ta' żbalji fil-medikazzjoni minħabba dożaġġ ta' kuljum minflok ta' darba fil-ġimgħa b'mod mhux intenzjonat huwa riskju identifikat importanti u l-prodotti kollha li fihom methotrexate li għalihom huma meħtieġa miżuri addizzjonali għall-minimizzazzjoni tar-riskju biex jiġi indirizzat dan irriskju (jiġifieri sostituzzjoni ta' fliexken/tubi b'folji, implimentazzjoni ta' materjal edukattiv u kard talpazjent), għandu jkollhom fis-seħħ pjan tal-ġestjoni tar-riskju (RMP) li jelenka l-attivitajiet kollha ta' farmakoviġilanza u l-miżuri għat-tnaqqis tar-riskju maqbula.
English: P
Maltese: P T. 2018
English: • For the treatment of autoimmune diseases, which require immunosuppressive therapy like rheumatoid arthritis, psoriasis, Crohn's disease and other autoimmune diseases, it is prescribed as a single low-dose, once a week.
Maltese: • Għat-trattament ta' mard awtoimmuni, li jeħtieġ terapija immunosoppressiva bħall-artrite rewmatika, il-psorijażi, il-marda ta' Crohn u mard awtoimmuni ieħor, huwa preskritt bħala doża waħda baxxa, darba fil-ġimgħa.
English: Taking into account that such replacement may require several technical changes and not to jeopardize the availability of methotrexate formulations in some Member States, the PRAC agreed to an implementation period of up to 4 years after finalisation of this procedure.
Maltese: Meta jitqies li tali sostituzzjoni tista' teħtieġ diversi bidliet tekniċi u ma tipperikolax id-disponibbiltà ta' formulazzjonijiet ta' methotrexate f'xi Stati Membri, il-PRAC qabel ma' perijodu ta' implimentazzjoni sa 4 snin wara li din il-proċedura tiġi finalizzata.
English: Admission to hospital and transfer of care between institutions and physicians was also noted as a root cause due to poor or a lack of communication between patient/physician, physician/physician, physician/nurse.
Maltese: Id-dħul fl-isptar u t-trasferiment talkura bejn l-istituzzjonijiet u t-tobba ġew innotati wkoll bħala kawża ewlenija minħabba lkomunikazzjoni batuta jew in-nuqqas ta' komunikazzjoni bejn il-pazjent/it-tabib, it-tabib/it-tabib, ittabib/l-infermier.
English: For this reason, the PRAC was of the view that the visual reminder agreed for the outer packaging of the oral formulations of methotrexate should also be implemented on the outer packaging of the parenteral formulations of methotrexate with at least one indication requiring once weekly dosing, and that the shorter warning agreed for the immediate packaging of the oral formulations should be implemented on the intermediate (where applicable) and immediate packaging of the parenteral formulations.
Maltese: Filwaqt li użu ta' kuljum minflok ta' darba fil-ġimgħa ta' methotrexate kien irrappurtat prinċipalment f'forom ta' dożaġġ orali f'indikazzjonijiet mhux onkoloġiċi, b'mod predominanti l-artrite rewmatika u l-psorijażi, kien hemm ukoll każijiet bl-użu ta' formulazzjonijiet parenterali, kif ukoll ħafna rapporti li ma speċifikawx imnejn jingħata.
English: It was noted that many different wordings and styles of warnings have been implemented, from very small information on one side of the packaging in black to large red framed information on several sides of the outer packaging, inclusion of a calendar or place to mark the day of intake as well as different texts for the warning.
Maltese: Ġie nnutat li kienu implimentati ħafna formulazzjonijiet ta' kliem u stili ta' twissija differenti, minn informazzjoni qasira ħafna b'tipa sewda fuq naħa waħda tal-imballaġġ għal informazzjoni b'tipa ħamra kbira fuq id-diversi naħat ta' barra talimballaġġ, l-inklużjoni ta' kalendarju jew post biex jiġi mmarkat il-jum tat-teħid, kif ukoll testi differenti għat-twissija.
English: To increase awareness of HCPs on the risk of medication errors and their possible consequences, it was considered that for methotrexate oral formulations, educational materials for healthcare professionals should be developed or updated, if already in place, to inform them on the potential for fatal overdose due to medication errors (ME), including daily instead of once weekly use, highlight the need to inform patients and relatives/carers about the once weekly dosing, and provide information on the importance to fill in prescriptions with clear instructions about once weekly dosing, defined day of intake, and to not use abbreviations.
Maltese: Barra minn hekk, għalkemm l-għadd ta' każijiet li jirrappurtaw żbalji fil-medikazzjoni b'formulazzjonijiet parenterali kien iżgħar minn dak b'formulazzjonijiet orali, ir-riskju ta' żball fil-medikazzjoni minħabba t-teħid/l-użu ta' kuljum minflok ta' darba fil-ġimgħa jitqies bħala problema ġenerali għall-prodotti kollha li fihom methotrexate b'tal-inqas indikazzjoni waħda li teħtieġ dożaġġ ta' darba fil-ġimgħa.
English: • A direct healthcare professionals communication was also agreed, together with a communication plan;
Maltese: • Intlaħaq qbil ukoll dwar komunikazzjoni diretta għall-professjonisti fil-qasam tal-kura tassaħħa, flimkien ma' pjan ta' komunikazzjoni;