FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased risk of tumor lysis syndrome at the dose initiation and during the dose-titration phase (see section 4.5).
Maltese: Żieda fir-riskju tas-sindromu tal-lisi tattumur fil-bidu tad-doża u matul il-fażi tattitrazzjoni tad-doża (ara sezzjoni 4.5).
English: Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A like ritonavir (see sections 4.3 and 4.5).
Maltese: Ġew irrappurtati interazzjonijiet, ma' prodotti mediċinali oħra, li jistgħu jipperikolaw il-ħajja u oħrajn fatali, f'pazjenti kkurati b'colchicine u inibituri qawwija ta' CYP3A bħal ritonavir (ara sezzjonijiet 4.3 u 4.5).
English: Divalproex, lamotrigine, phenytoin Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent induces oxidation by CYP2C9 and glucuronidation and as a result is expected to decrease the plasma concentrations of anticonvulsants.
Maltese: L-għotja ta' ritonavir flimkien ma' dihydroergotamine, ergonovine, ergotamine, methylergonovine aktarx li twassal għal żieda filkonċentrazzjoni fil-plażma tad-derivattivi tal-ergotina, u għalhekk hija kontra-indikata (ara sezzjoni 4.3).
English: For additional information on the effect of ritonavir on co-administered protease inhibitor metabolism, see section 4.5 and refer to the Summary of Product Characteristics of the particular co-administered PIs.
Maltese: Għal aktar informazzjoni fuq l-effett ta' ritonavir fuq il metaboliżmu tal-impeditur protejaż li jingħata miegħu, ara sezzjoni 4.5 u irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott tal-PIs partikolari li jkunu ngħataw ma' ritonavir.
English: The following adverse reactions of moderate to severe intensity with possible or probable relationship to ritonavir have been reported.
Maltese: Ġew irrapportati l-effetti avversi segwenti b'relazzjoni possibbli jew probabbli ma' ritonavir, u li huma ta' intensità minn moderata sa severa.
English: ↑ 17-fold ↔ ND
Maltese: 1, doża waħda
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of dexamethasone.
Maltese: Ritonavir dożat biex iżid l-effett farmakokinetiku jew bħala aġent antiretrovirali jimpedixxi CYP3A, u għalhekk huwa mistenni li jżid ilkonċentrazzjoni fil-plażma ta' dexamethasone.
English: Nevirapine
Maltese: Anafilassi
English: Ritonavir dosed as a pharmacokinetic enhancer The interaction profiles of HIV-protease inhibitors, co-administered with low dose ritonavir, are dependent on the specific co-administered protease inhibitor.
Maltese: Peress li ritonavir jiġi fil-biċċa l-kbira tiegħu metabolizzat mill-fwied u jeħel ħafna mal-proteini tad-demm, probabilment id-dijalisi ma tkunx ta' benefiċċju fit-tneħħija sinifikanti tal-mediċina.
English: Dysgeusia, oral and peripheral paraesthesia, headache, dizziness, peripheral neuropathy
Maltese: Komuni ħafna Disġewżja, parasteżija periferali u madwar il-ħalq, uġigħ ta' ras, sturdament, newropatija periferali
English: Menorrhagia
Maltese: Raġuni
English: CYP3A4 inhibitors increase the exposure of lomitapide, with strong inhibitors increasing exposure approximately 27-fold.
Maltese: Impedituri ta' CYP3A4 iżidu l-esponiment ta' lomitapide, b'impedituri b'saħħithom ikabbru l-esponiment għal madwar 27 darba.
English: Co-administration of atazanavir with ritonavir at doses greater than 100 mg once daily has not been clinically evaluated.
Maltese: L-għoti flimkien ta' fosamprenavir u ritonavir f'dożi akbar minn 100 mg darba kuljum ma' ġiex evalwat klinikament.
English: The concomitant use of ritonavir is not recommended due to potential increase in riociguat exposure (see section 4.5).
Maltese: L-użu konkomitanti ta' ritonavir mhuwiex rakkomandat minħabba ż-żieda potenzjali fl-espożizzjoni ta' riociguat (ara sezzjoni 4.5).
English: Renal disease
Maltese: Mard Renali
English: The use of pethidine and ritonavir is contraindicated due to the increased concentrations of the metabolite, norpethidine, which has both analgesic and CNS stimulant activity.
Maltese: L-użu ta' pethidine u ritonavir huwa kontro-indikat minħabba ż-żieda filkonċentrazzjoni tal-metabolit norpethidine, li għandu attività analġesika, kif ukoll attività stimulanti fuq is-sistema nervuża (CNS).
English: UNITED KINGDOM
Maltese: Česká republika
English: Important information regarding medicinal product interactions when ritonavir is used a pharmacokinetic enhancer is also contained in the Summary of Product Characteristics of the co-administered protease inhibitor.
Maltese: Informazzjoni importanti dwar interazzjonijiet ta' prodotti mediċinali meta ritonavir jintuża biex iżid l-effett farmakokinetiku tinsab ukoll fis-Sommarju tal-Karatteristiċi tal-Prodott tal-impeditur protejaż li jkun ingħata ma' ritonavir.
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of buspirone.
Maltese: Ritonavir dożat biex iżid l-effett farmakokinetiku jew bħala aġent antiretrovirali jimpedixxi CYP3A, u għalhekk huwa mistenni li jżid ilkonċentrazxzjonijiet fil-plażma ta' buspirone.
English: More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.5 and refer to the bedaquiline Summary of Product Characteristics).
Maltese: Monitoraġġ aktar frekwenti b'elettrokardjogramma u l-monitoraġġ ta' transaminases huwa rakkomandat (ara sezzjoni 4.5 u irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' bedaquiline).
English: Decreased R-warfarin levels may lead to reduced anticoagulation, therefore it is recommended that anticoagulation parameters are monitored when warfarin is co-administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Maltese: Livelli mnaqqsa ta' R-warfarin jistgħu jwasslu għal tnaqqis fil-koagulazzjoni, għalhekk huwa rrakkomandat li meta warfarin jittieħed flimkien ma' ritonavir mogħti f'doża bħala aġent antiretrovirali jew biex iżid l-effett farmakokinetiku, jiġu monitorjati ilparametri ta' kontra l-koagulazzjoni.
English: Post-marketing cases have been reported indicating a potential interaction between ritonavir containing products and levothyroxine.
Maltese: Ġew irrappurtati każijiet ta' wara ttqegħid fis-suq li indikaw interazzjoni potenzjali bejn prodotti li fihom ritonavir u levothyroxine.
English: If the benefit is considered to outweigh the risk and ritonavir must be used, reduce the ibrutinib dose to 140 mg and monitor patient closely for toxicity.
Maltese: Jekk il-benefiċċju huwa meqjus li huwa akbar mir-riskju u ritonavir għandu jintuża, naqqas id-doża ta' ibrutinib għal 140 mg u mmonitorja mill-qrib il-pazjent għal tossiċità.
English: Other information about Dutrebis
Maltese: Informazzjoni oħra dwar Dutrebis
English: The full EPAR and risk management plan summary for Dutrebis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: One active substance, lamivudine, is a ‘nucleoside reverse transcriptase inhibitor' (NRTI).
Maltese: "inibitur ta' nucleoside reverse-transcriptase" (NRTI).
English: The other active substance, raltegravir, is an ‘integrase inhibitor'.
Maltese: Is-sustanza attiva l-oħra, raltegravir hija "inibitur integrase".
English: Dutrebis is a medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Maltese: Dutrebis jintuża fil-kura ta' pazjenti infettati bil-virus tal-immunodefiċjenza tal-bniedem tat-tip 1 (HIV1), virus li jikkawża s-sindrome mill-immunodefiċjenza akkwiżita (AIDS).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dutrebis on 26 March 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Dutrebis fis-26 ta' Marzu 2015.
English: The active substances in Dutrebis are already available in the European Union (EU) as singlecomponent medicines: lamivudine as Epivir since 1996, and raltegravir as Isentress since 2007.
Maltese: Is-sustanzi attivi f'Dutrebis huma diġà disponibbli fl-Unjoni Ewropea (UE) bħala mediċini b'komponent wieħed: lamivudine bħala Epivir mill-1996, u raltegravir bħala Isentress mill-2007.
English: This is a summary of the European public assessment report (EPAR) for Dutrebis.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Dutrebis.
English: Because lamivudine and raltegravir are already approved individually to treat HIV infection, the company presented data from the studies used to approve these medicines, including a study involving 160 patients given raltegravir with lamivudine (plus another HIV medicine, tenofovir) for a total of 240 weeks.
Maltese: Peress li lamivudine u raltegravir huma diġà approvati b'mod individwali biex jikkuraw infezzjoni talHIV, il-kumpanija ppreżentat data mill-istudji użati biex jiġu approvati dawn il-mediċini, inkluż studju li jinvolvi 160 pazjent li ngħataw raltegravir ma' lamivudine (flimkien ma' mediċina tal-HIV oħra, tenofovir) għal total ta' 240 ġimgħa.
English: What are the risks associated with Dutrebis?
Maltese: X'inhuma r-riskji assoċjati ma' Dutrebis?
English: Dutrebis is available as tablets containing 150 mg of lamivudine and 300 mg of raltegravir, and the recommended dose is one tablet twice a day.
Maltese: Dutrebis jiġi bħala pilloli li fihom 150 mg ta' lamivudine u 300 mg ta' raltegravir, u d-doża rakkomandata hija pillola waħda darbtejn kuljum.
English: Other common side effects with lamivudine are malaise (feeling generally unwell), tiredness, nasal signs and symptoms, diarrhoea and cough.
Maltese: Effetti sekondarji komuni oħrajn b'lamivudine huma telqa (tħossok ma tiflaħx b'mod ġenerali), għeja, sinjali u sintomi fl
English: It blocks an enzyme called integrase that is needed for the subsequent stage of virus replication.
Maltese: Timblokka enzima msejħa integrase li hija meħtieġa għall-istadju sussegwenti ta' replikazzjoni talvirus.
English: The results of the studies showed that Dutrebis produced similar levels lamivudine in the body to lamivudine taken separately; although the levels of raltegravir were slightly different, Dutrebis was shown to produce levels of raltegravir that were similarly effective in controlling the virus.
Maltese: Ir-riżultati tal-istudji wrew li Dutrebis ipproduċa livelli simili fil-ġisem bħal meta lamivudine ttieħed b'mod separat, għalkemm il-livelli ta' raltegravir kienu kemxejn differenti, Dutrebis intwera li jipproduċi livelli ta' raltegravir li kienu effikaċi bl-istess
English: A risk management plan has been developed to ensure that Dutrebis is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Dutrebis jintuża bl-aktar mod sigur possibbli.
English: It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell.
Maltese: Din taħdem billi timblokka l-attività ta' reverse transcriptase, enzima meħtieġa mill-HIV biex tipproduċi l-istruzzjonijiet ġenetiċi biex tagħmel aktar virusijiet ladarba tkun infettat iċ-ċellola.
English: For the full list of all side effects and restrictions with Dutrebis, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Dutrebis, ara l-fuljett ta' tagħrif.
English: Dutrebis can only be obtained with a prescription and treatment should be prescribed by a doctor who is experienced in managing HIV infections.
Maltese: Dutrebis jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tiġi preskritta minn tabib esperjenzat filġestjoni ta' infezzjonijiet tal-HIV.
English: Dutrebis contains the active substances lamivudine and raltegravir and is only for use in patients whose infection is not resistant to these medicines or certain related antiviral medicines.
Maltese: Dutrebis fih is-sustanzi attivi lamivudine u raltegravir u għandu jintuża biss f'pazjenti li l-infezzjoni tagħhom mhijiex reżistenti għal dawn il-mediċini jew għal ċerti mediċini antivirali relatati.
English: The main measure of effectiveness was the proportion of patients with a reduction of the levels of virus in the blood (viral load) to fewer than 50 copies of HIV RNA per ml, which was 68.8%.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-proporzjon ta' pazjenti bi tnaqqis fil-livelli ta' virus fid-demm (tagħbija virali) għal inqas minn 50 kopja ta' HIV RNA għal kull ml, li kien
English: The PRAC adopted a recommendation on 30 November 2017 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Fit-30 ta' Novembru 2017, il-PRAC adotta rakkomandazzjoni, li mbagħad ġiet ikkunsidrata mis-CMDh, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
English: Late crossing of the standard treatment nomogram were seen in 19% of the cases.
Maltese: L-inkroċjar tard tan-nomogramma tal-kura standard deher fi 19% tal-każijiet.
English: If the patient presents to emergency medical care in time following an overdose, there is an effective antidote available - N-acetylcysteine (NAC).
Maltese: Jekk il-pazjent jiġi ammess għal kura medika ta' emerġenza fil-ħin wara doża eċċessiva, hemm antidotu effettiv disponibbli - N-acetylcysteine (NAC).
English: There were 5 fatal cases reported out of the 319 cases.
Maltese: Mit-319il każ, ġew irrappurtat 5 każijiet fatali.
English: Eleven patients (21%) had a serum alanine aminotransferase (ALT), above the reference range (ALT >50 IU/L) at 24 h or later.
Maltese: Ħdax-il pazjent (21%) kellhom alanina aminotransferażi (ALT) fis-seru, li taqbeż il-limiti ta' referenza (ALT >50
English: B. Tramadol/paracetamol prolonged release tablets
Maltese: B. Pilloli tat-tramadol/tal-paracetamol li jerħu l-mediċina b'mod prolungat
English: Of these 319 cases, almost all (98%) are from Sweden (67%) and Australia (31%).
Maltese: Minn dawn it319-il każ, kważi kollha (98%) ġejjin mill-Iżvezja (67%) u mill-Awstralja (31%).
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for modified release paracetamol containing medicinal products (see Annex I).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali li fihom il-paracetamol li terħi l-mediċina b'mod modifikat (ara l-Anness I).
English: Data published by the Swedish Poison Centre described a series of 53 patients with reported overdose with paracetamol 665mg MR (range 10-166 g).
Maltese: Data ppubblikata miċ-Ċentru tal-Avvelenament Żvediż iddeskriviet sensiela ta' 53 pazjent b'dożi eċċessivi rrapportati bil-paracetamol 665mg MR (firxa ta' 10-166 g).
English: Diliban retard is not yet placed in the EU market.
Maltese: Diliban retard għadha ma tpoġġietx fis-suq tal-UE.
English: These include products with paracetamol as a single ingredient; namely modified release (MR) tablets containing 500 mg, 665 mg or 1000 mg paracetamol, and paracetamol 500 mg prolonged release tablet.
Maltese: Dawn jinkludu prodotti bil-paracetamol bħala ingredjent wieħed; prinċipalment pilloli li jerħu l-mediċina b'mod modifikat (MR, modified release) li fihom il-paracetamol ta' 500 mg, 665 mg jew 1000 mg, u pillola talparacetamol ta' 500 mg li terħi l-mediċina b'mod prolungat.
English: Furthermore, there are prolonged-release combination products containing tramadol/paracetamol 75 mg/650 mg.
Maltese: Barra minn dan, hemm prodotti kkombinati li jerħu l-mediċina b'mod prolungat li fihom it-tramadol/il-paracetamol ta' 75 mg/650 mg.
English: This unpredictability was not sufficiently mitigated by the modelling and simulation measures submitted by the MAH GSK Consumer Healthcare.
Maltese: Din limprevedibbiltà ma ġietx mitigata biżżejjed permezz tal-miżuri tal-immudellar u tas-simulazzjoni li ġew ippreżentati mill-MAH GSK Consumer Healthcare.
English: PRAC was in agreement with the experts views.
Maltese: Tlaqqgħet it-tieni laqgħa tal-grupp ta' esperti.
English: The MAH referred to the limited number of overdoses reported with the fixed-dose combination are limited.
Maltese: L-MAH irrefera li n-numru limitat ta' dożi eċċessivi rrapportati mal-kombinazzjoni ta' doża fissa huwa limitat.
English: The MAH submitted a literature review to justify the clinical benefit of the tramadol/paracetamol MR combination in pain management.
Maltese: L-MAH ippreżenta riċensjoni ("literature review") sabiex jiġġustifika l-benefiċċju kliniku talkombinazzjoni tat-tramadol/tal-paracetamol MR fil-ġestjoni tal-uġigħ.
English: For paracetamol MR tablets 319 spontaneous adverse event reports of overdose (OD) were identified since marketing authorisation.
Maltese: Għall-pilloli tal-paracetamol MR, ġew identifikati 319-il rapport ta' avveniment avvers spontanju ta' doża eċċessiva (OD, overdose) mill-awtorizzazzjoni għat-tqegħid fis-suq tal-komunità.
English: The CMDh considered the documentation submitted by one MAH (KRKA d.d., Novo mesto) in support of their product and concluded that it did not affect the conclusions of the PRAC.
Maltese: Is-CMDh ikkunsidra d-dokumenazzjoni li ġiet ippreżentata minn MAH wieħed (KRKA d.d., Novo mesto) bħala appoġġ għall-prodott tagħhom u kkonkluda li dan ma affettwax il-konklużjonijiet tal-PRAC.
English: The vast majority of the serious cases reported with paracetamol MR formulation happened in overdoses with more than 30 g of paracetamol (considered a massive overdose by Marks et al, 2017).
Maltese: Il-maġġoranza kbira tal-każijiet serji rrapportati b'formulazzjoni MR tal-paracetamol seħħew f'dożi eċċessivi b'aktar minn 30 g ta' paracetamol (li titqies bħala doża eċċessiva enormi minn Marks et al, 2017).
English: A. Paracetamol modified release tablets
Maltese: Pilloli tal-paracetamol li jerħu l-mediċina b'mod modifikat
English: Paracetamol is used in various pain types such as headache, migraine, dysmenorrhoea, sore throat, musculoskeletal pain, pain after dental procedures/tooth extraction, toothache and the pain of osteoarthritis and for fever.
Maltese: Il-paracetamol tintuża f'diversi tipi ta' wġigħ bħall-uġigħ ta' ras, l-emigranja, id-diżmenorrea, l-uġigħ fil-griżmejn, l-uġigħ muskoloskeletali, l-uġigħ wara proċeduri dentali/il-qlugħ tas-snien, l-uġigħ fis-snien u l-uġigħ talosteoartrite u għad-deni.
English: Data from the study by Chiew and colleagues (2017) indicates that rate of hepatotoxicity declines when either activated charcoal or increased NAC dose are administered to patients.
Maltese: Data mill-istudju minn Chiew u kollegi (2017) tindika li r-rata tal-epatossiċità tonqos meta jingħataw jew karbonju attiv jew doża akbar ta' NAC lillpazjenti.
English: Dose is an important factor when interpreting poisoning data with paracetamol.
Maltese: Id-doża hija fattur importanti fl-interpretazzjoni ta' data ta' avvelenament bilparacetamol.
English: Under normal conditions of use, it has an established favourable benefit/risk profile.
Maltese: Taħt kundizzjonijiet ta' użu normali, hija stabbilixxiet profil favorevoli talbenefiċċji u tar-riskji.
English: To address uncertainties in the management of overdose cases with the MR formulation of paracetamol, a mechanistic model would be required taking into account other relevant parameters (e.g. solubility of paracetamol, kinetics of the toxic metabolite (NAPQUI) and of NAC administered as antidote).
Maltese: MR tal-paracetamol, se jkun meħtieġ mudell mekkanistiku li jikkunsidra parametri rilevanti oħrajn (eż. is-solubbiltà tal-paracetamol, il-kinetika talmetabolit tossiku (NAPQUI) u tan-NAC li jingħata bħala antidotu).
English: The proposed risks minimisations by the MAHs are not considered feasible, effective and proportionate by the PRAC.
Maltese: Il-minimizzazzjonijiet tar-riskji proposti mill-MAHs ma ġewx ikkunsidrati bħala fattibbli, effettivi u proporzjonati mill-PRAC.
English: Following the adoption of the PRAC recommendation in September 2017, two MAHs (GSKCH and KRKA d.d., Novo mesto) have requested the re-examination of the recommendation and submitted detailed grounds for the re-examination.
Maltese: Wara l-adozzjoni tar-rakkomandazzjoni tal-PRAC f'Settembru 2017, żewġ MAHs (GSKCH and KRKA d.d., Novo mesto) talbu l-eżaminazzjoni mill-ġdid tar-rakkomandazzjoni u ppreżentaw raġunijiet dettaljati għall-eżaminazzjoni mill-ġdid.
English: From the literature review two publications were the most relevant where Lasko and colleagues (2012) investigated the efficacy of MR tramadol/paracetamol formulation for acute low back pain, while Lee and colleagues (2013) for chronic low back pain.
Maltese: Mill-ħarsa analitika, żewġ pubblikazzjonijiet kienu l-aktar rilevanti, fejn Lasko u kollegi (2012) investigaw leffikaċja tal-formulazzjoni MR tat-tramadol/tal-paracetamol għal uġigħ akut fil-parti t'isfel tad-dahar, filwaqt li Lee u kollegi (2013) investigawha għal uġigħ kroniku fil-parti t'isfel tad-dahar.
English: Overall summary of the scientific evaluation by the PRAC Paracetamol is one of the most commonly utilised compounds worldwide; its use as an anti-pyretic or analgesic drug has been predominant since 1955.
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika mill-PRAC Il-paracetamol hija waħda mill-aktar komposti li tintuża b'mod komuni madwar id-dinja; l-użu tagħha bħala mediċina antipirjetika jew analġeżika ilu predominanti mill-1955.
English: In addition, publications describing case series of overdose with modified-release paracetamol from Australia, such as Graudins and colleagues (2010, 2014) have been assessed as providing experience on the treatment protocol with NAC and supportive information regarding PK of paracetamol in cases of overdose with MR formulation.
Maltese: Barra minn hekk, il-pubblikazzjonijiet li jiddeskrivu serje ta' każijiet ta' doża eċċessiva b'paracetamol li terħi l-mediċina b'mod modifikat mill-Awstralja, bħal Graudins u kollegi (2010, 2014) ġew ivvalutati bħala li jipprovdu esperjenza dwar il-protokoll ta' kura bin-NAC u informazzjoni ta' appoġġ rigward ilPK tal-paracetamol f'każijiet ta' doża eċċessiva b'formulazzjoni MR.
English: Due to the difference in the severity of conditions, there is a possibility of difference in the risk of suicidality between these two populations of patients using this fixed-dose combination with tramadol versus the MR paracetamol as monocomponent.
Maltese: Minħabba d-differenza fis-severità tal-kundizzjonijiet, hemm il-possibbiltà ta' differenza fir-riskju ta' suwiċidju bejn iż-żewġ gruppi ta' pazjenti li jużaw din il-kombinazzjoni ta' doża fissa bit-tramadol kontra l-paracetamol MR bħala l-monokomponent.
English: The PRAC noted the claimed specific benefits of the MR formulations related to a reduction of daily tablet intake; from 4 to 3 times daily dosing for the single ingredient products, and the simplified regimen of 2 from 4 tablets for the combination products.
Maltese: Il-PRAC innota l-benefiċċji speċifiċi ddikjarati tal-formulazzjonijiet MR relatati ma' tnaqqis fid-doża talpilloli ta' kuljum; minn 4 darbiet għal 3 darbiet ta' doża kuljum għall-prodotti b'ingredjent wieħed, u r-reġim simplifikat ta' 2 pilloli minn 4 għall-prodotti kkombinati.
English: Other risk minimisation measures proposed by the MAH to address the risk associated with overdose of the combination were considered by PRAC such as update of the product information to include stronger warnings related to at-risk patients and concomitant use with other paracetamol-containing products, DHPC and restriction of availability of certain type of packaging (i.e. bottles) and restriction of available pack size (max. 48 tablets).
Maltese: Il-PRAC ikkunsidra attivitajiet oħra tal-minimizzar tar-riskju proposti mill-MAH sabiex jiġi indirizzat irriskju assoċjat ma' doża eċċessiva tal-kombinazzjoni, bħall-aġġornament tal-informazzjoni dwar ilprodott sabiex jiġu inklużi twissijiet aktar qawwijin relatati ma' pazjenti li jinsabu f'riskju u l-użu simultanju ma' prodotti oħra li fihom il-paracetamol, id-DHPC u r-restrizzjoni tad-disponibbiltà ta' ċertu tip ta' imballaġġ (jiġifieri fliexken) u r-restrizzjoni tad-daqs tal-pakkett disponibbli (mass.