FrancophonIA/ELRC3.0 huggingface dataset:
English: In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m2 immediately followed by cisplatin 75 mg/m2 over 30-60 minutes.
Maltese: F'pazjenti li qatt ma ħadu l-kimoterapija qabel u li qed jiġu ikkurati għall-kanċer tal-pulmun li mhux ta' ċelluli żgħar, is-sistema tad-dożi irrakkomandata hija docetaxel 75 mg/m2 segwit immedjatament b'cisplatin 75 mg/m2 fuq perjodu ta' bejn 30 u 60 minuta.
English: Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%);
Maltese: Deni (G3/4: 3.6%); Żamm tal-fluwidu (G3/4: 1.2%);
English: Prophylactic G-CSF should be used to mitigate the risk of haematological toxicities (see also Dose adjustments during treatment).
Maltese: Il-profilassi bil-G-CSF għandha tintuża biex tnaqqas ir-riskju ta' effetti tossiċi ematoloġiċi (Ara ukoll l-aġġustamenti fid-Doża waqt it-trattament).
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Maltese: TUŻAX oħra mediċina ta' docetaxel li fihom zewġ kunjetti (konċentrat u solvent) ma' dan ilmediċina (DOCETAXEL KABI 80 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni, li jkun fih biss kunjett wieħed).
English: Ref. EMEA/CHMP/466849/2009 EMEA/H/A-30/1003
Maltese: EMEA/714046/2009 EMEA/H/A-30/1003
English: Co-rapporteur(s):
Maltese: Co-Rapporteur:
English: It contains the active substance meropenem.
Maltese: Fih is-sustanza attiva meropenem.
English: London, 23 July 2009 Doc.
Maltese: Londra, 19 ta' Ottubru 2009 Dok. ta' Ref.
English: The CHMP agreed on a harmonised list of contra-indications.
Maltese: Is-CHMP qabel fuq lista armonizzata ta' kontra-indikazzjonijiet.
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Maltese: L-Artikolu 30 tad-Direttiva 2001/83/KE kif emendata, referenza fuq il-bażi ta' deċiżjonijiet diverġenti adottati mill-Istati Membri.
English: • pneumonia (infection of the lungs);
Maltese: • pnewmonja (infezzjoni tal-pulmuni);
English: The review was carried out under an ‘Article 30' referral1.
Maltese: Ir-reviżjoni twettqet skont referenza tal-‘Artikolu 29'1.
English: The active substance in Meronem, meropenem, is an antibiotic that belongs to the group ‘carbapenems'.
Maltese: Is-sustanza attiva f'Meronem, meropenem, hija antibijotiku li jappartjeni għall-grupp ‘carbapenems'.
English: • for pneumonia, complicated urinary tract infections, complicated intra-abdominal infections, intraand post-partum infections and complicated skin and soft tissue infections, the recommended dose in adults and children weighing more than 50 kg should 500 mg or 1 g every eight hours, while children aged from three months to 11 years and those weighing less than 50 kg should be given 10 or 20 mg/kg every eight hours.
Maltese: • għal pnewmonja, infezzjonijiet ikkumplikati tal-passaġġ tal-awrina, infezzjonijiet ikkumplikati intra-addominali, infezzjonijiet fi u wara t-twelid u infezzjonijiet ikkumplikati tal-ġilda u tattessuti rotob, id-doża rakkomandata fl-adulti u fit-tfal li jiżnu iktar minn 50 kg għandha tkun 500 mg jew 1 g kull tmien sigħat, filwaqt li tfal ta' bejn it-tliet xhur u l-11-il sena u dawk li jiżnu inqas minn 50 kg għandhom jingħataw 10 jew 20 mg/kg kull tmien sigħat.
English: • broncho-pulmonary infections in patients with cystic fibrosis;
Maltese: • infezzjonijiet bronko-pulmonari f'pazjenti b'fibrożi ċistika;
English: 23 July 2009
Maltese: 23 ta' Lulju 2009
English: What is Meronem?
Maltese: X'inhu Meronem?
English: Meronem has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Meronem ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproċi u Deċentralizzati - Umani (CMD(h)).
English: • for broncho-pulmonary infections in cystic fibrosis and acute bacterial meningitis, the CHMP recommended a dose of 2 g every eight hours in adults and children weighing over 50 kg, and 40 mg/kg every eight hours in children aged from three months to 11 years and those weighing less than 50 kg.
Maltese: • għal infezzjonijiet bronko-pulmonari f'fibrożi ċistika u f'meninġite batterjali akuta, is-CHMP irrakkomanda doża ta' 2 g kull tmien sigħat fl-adulti u fi tfal li jiżnu iktar minn 50 kg, u 40 mg/kg kull tmien sigħat fi tfal ta' bejn it-tliet xhur u l-11-il xahar u dawk li jiżnu inqas minn 50 kg.
English: Questions and answers on the referral for Meronem and associated names meropenem powder for solution for injection or infusion 500 mg and 1 g
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Meronem u ismijiet assoċjati meropenem trab għal soluzzjoni għal injezzjoni jew infużjoni 500 mg u 1 g
English: Meronem is used to treat various bacterial infections including infections of the lungs, urinary tract (structures that carry urine), the abdomen, skin, the female reproductive system and brain.
Maltese: Meronem jintuża biex jittratta infezzjonijiet batterjali varji nkluż infezzjonijiet tal-pulmuni, talpassaġġ tal-awrina (strutturi li jġorru l-awrina), tal-addome, tal-ġilda, tas-sistema riproduttiva tal-mara u tal-moħħ.
English: Why was Meronem reviewed?
Maltese: Għaliex ġie rivedut Meronem?
English: At the start of the referral, some Member States did not include hypersensitivity (allergy) to carbapenems, penicillins or other beta-lactam antibiotics as contra-indications (situations where the medicine must not be used) and some Member States included hypersensitivity to excipients (other ingredients in the medicine).
Maltese: Fil-bidu tar-referenza, xi Stati Membri ma nkludewx l-ipersensittività (allerġija) għal carbapenems, peniċillini jew antibijotiċi beta-lactam oħrajn bħala kontra-indikazzjonijiet (sitwazzjonijiet fejn ilmediċina ma għandhiex tintuża) u xi Stati Membri nkludew l-ipersensittività għal sustanzi mhux attivi (ingredjenti oħrajn fil-mediċina).
English: The CHMP harmonised the SPC section on special warnings and retained warnings about convulsions and hepatic reactions.
Maltese: Is-CHMP armonizza s-sezzjoni tal-SPC dwar twissijiet speċjali u żamm it-twissijiet dwar konvulżjonijiet u reazzjonijiet tal-fwied.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
Maltese: Is-CHMP, fid-dawl tad-dejta ppreżentata u tad-diskussjoni xjentifika fi ħdan il-Kumitat, kien talopinjoni li l-SPCs, it-tikketti u l-fuljetti ta' tagħrif għandhom jiġu armonizzati fl-UE kollha.
English: • acute bacterial meningitis (inflammation of the membranes that surround the brain and spine).
Maltese: • meninġite batterjali akuta (infjammazzjoni tal-membrani li jiċċirkondaw il-moħħ u l-ispina).
English: The company that markets Meronem is AstraZeneca.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet studju ta' Meronem u ismijiet assoċjati.
English: On 1 October 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Meronem and associated names in the EU.
Maltese: Fl-1 ta' Ottubru 2008, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP sabiex tarmonizza lawtorizzazzjonijiet ta' tqegħid fis-suq għal Meronem u ismijiet assoċjati fl-UE.
English: • complicated skin and soft tissue infections;
Maltese: • infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti tal-ġilda;
English: Meronem and associated names are authorised in the EU via national procedures.
Maltese: Meronem u ismijiet assoċjati huma awtorizzati fl-UE permezz ta' proċeduri nazzjonali.
English: The Committee recommended that Meronem should not be used in patients who are hypersensitive to any carbapenem medicine or in patients who have severe hypersensitivity to any type of beta-lactam anti-bacterial medicines such as penicillins or cephalosporins.
Maltese: Il-Kumitat irrakkomanda li Meronem ma għandux jintuża f'pazjenti li huma ipersensittivi għal xi mediċina ta' carbapenem jew f'pazjenti li għandhom ipersensittività qawwija għal xi tip ta' mediċina anti-batterjali beta lactam bħall-peniċillini jew cephalosporins.
English: • complicated infections in the abdomen;
Maltese: • infezzjonijiet ikkumplikati fl-addome;
English: • complicated urinary tract infections;
Maltese: • infezzjonijiet ikkumplikati tal-passaġġ tal-awrina;
English: Because the recommended dose for both adults and children differed among Member States, the CHMP recommended harmonised dosage schedules:
Maltese: Minħabba li d-doża rakkomandata kemm għall-adulti kif ukoll għat-tfal kienet differenti fost l-Istati Membri, is-CHMP irrakkomanda skedi ta' dożaġġ armonizzati:
English: At the start of the referral, some of the indications such as skin and skin tissue infections and urinary tract infections or infections of the female reproductive system were not approved in all Member States.
Maltese: Fil-bidu tar-referenza, uħud mill-indikazzjoni bħal infezzjonijiet tal-ġilda u tat-tessut tal-ġilda u infezzjonijiet tal-passaġġ tal-awrina jew infezzjonijiet tas-sistema riproduttiva tal-mara ma ġewx
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Meronem and associated names in the European Union (EU).
Maltese: Il-Kumitat talAġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) kkonkluda li hemm bżonn li linformazzjoni tal-preskrizzjoni tiġi armonizzata għal Meronem u ismijiet assoċjati fl-Unjoni Ewropea (UE).
English: The active substance in Clopidogrel Acino Pharma GmbH, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Clopidogrel Acino Pharma GmbH, clopidogrel, hu inibitur tal-aggregazzjoni talplatelets.
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet ta' CHMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: This means that Clopidogrel Acino Pharma GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: GmbH huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: clopidogrel EPAR summary for the public
Maltese: clopidogrel Sommarju tal-EPAR għall-pubbliku
English: Because Clopidogrel Acino Pharma GmbH is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: GmbH huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries); The medicine can only be obtained with a prescription.
Maltese: • pazjenti b'mard fl-arterji periferiku (problemi bil-fluss tad-demm fl-arterji);
English: Clopidogrel Acino Pharma GmbH is a medicine that contains the active substance clopidogrel.
Maltese: GmbH huwa mediċina li fiha s-sustanza attiva clopidogrel.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument mistoqsija-u-tweġiba hawn.
English: Clopidogrel Acino Pharma GmbH is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: GmbH jintuża f'adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis tal-arterji). Clopidogrel Acino Pharma
English: What are the benefit and risk of Clopidogrel Acino Pharma GmbH?
Maltese: Għaliex ġie approvat Clopidogrel Acino Pharma GmbH?
English: Because Clopidogrel Acino Pharma GmbH is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: GmbH huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċju u r-riskju tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: This summary was last updated in 07-2009.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 07-2009.
English: The standard dose of Clopidogrel Acino Pharma GmbH is one 75 mg tablet once a day, taken with or without food.
Maltese: Id-doża standard ta' Clopidogrel Acino Pharma GmbH hija ta' pillola waħda ta' 75 mg darba kuljum, mal-ikel jew fuq stonku vojt.
English: Sleep 2011; 34: A199.
Maltese: 34: A199.
English: Oxynal 10mg/5mg, 20mg/10mg prolonged-release tablets and Targin 5mg/2.5mg, 10mg/5mg, 20mg/10mg, 40mg/20mg prolonged-release tablets and associated names (OXN PR) are fixed combination products of oxycodone hydrochloride and naloxone hydrochloride.
Maltese: Oxynal 10mg/5mg, 20mg/10mg pilloli ta' rilaxx fit-tul u Targin 5mg/2.5mg, 10mg/5mg, 20mg/10mg, 40mg/20mg pilloli ta' rilaxx fit-tul u ismijiet assoċjati (OXN PR) huma prodotti ta' kombinazzjoni fissa ta' oxycodone hydrochloride u naloxone hydrochloride.
English: • The Committee considered the referral under Article 13(2) of Regulation No 1234/2008.
Maltese: • Il-Kumitat ikkunsidra r-riferiment skont l-Artikolu 13(2) tar-Regolament Nru 1234/2008.
English: The CHMP also took note of the risks of iatrogenic drug dependence, drug abuse or misuse, augmentation, tolerance, and psychological dependence associated with Oxynal and Targin and associated names.
Maltese: Is-CHMP ta kas ukoll tar-riskji ta' dipendenza jatroġenika tal-mediċini, abbuż jew użu ħażin tal-mediċina, awmentazzjoni, tolleranza, u dipendenza psikoloġika assoċjati ma' Oxynal u Targin u ismijiet assoċjati.
English: No case of augmentation, tolerance, psychological dependence (addiction), abuse or misuse was reported in the studies OXN3502/S.
Maltese: Ebda kas ta' awmentazzjoni, tolleranza, dipendenza psikoloġika (vizzju), abbuż jew użu ħażin ma ġie rrappurtati fl-istudji OXN3502/S.
English: The frequency of adverse events and related adverse events was mostly comparable for both study phases (OXN3502/S) and points to a better tolerability of OXN PR in the extension phase.
Maltese: Il-frekwenza ta' avvenimenti avversi u avvenimenti avversi relatati ġeneralment kienet komparabbli għaż-żewġ fażijiet ta' studju (OXN3502/S) u turi tollerabilità aħjar għal OXN PR fil-fażi ta' estensjoni.
English: No convincing scientific evidence has been provided in the perspective of public health that the benefit of the fixed dose combination of oxycodone/naloxone in the treatment of idiopathic restless leg syndrome (IRLS) outweighs the expected adverse effects that are associated with the use of strongopioids in doses equipotent to doses up to 90 mg of oral morphine; dependence, withdrawal, augmentation, misuse and abuse.
Maltese: Ma ġiet ipprovduta ebda evidenza xjentifika konvinċenti fil-perspettiva tas-saħħa pubblika li lbenefiċċju ta' kombinazzjoni b'doża fissa ta' oxycodone/naloxone fil-kura ta' sindromu ta' riġlejn irrekwieti idjopatiku (IRLS) jegħleb l-effetti avversi mistennija li huma assoċjati mal-użu ta' opjojdi qawwijin f'dożi ekwipotenti għal dożi sa 90 mg ta' morfina orali; dipendenza, irtirar, awmentazzjoni, użu ħażin u abbuż.
English: There were no notable differences in the frequency of adverse events, severe adverse events and serious adverse events (overall and treatment-related) for young vs. elderly subjects as well as for females vs. males.
Maltese: Ma kienx hemm differenzi notevoli fil-frekwenza ta' avvenimenti avversi, avvenimenti avversi severi u avvenimenti avversi serji (ġenerali jew relatati mal-kura) għal suġġetti żgħażagħ vs. anzjani kif ukoll għal nisa vs. irġiel.
English: Further 10 patients out of 176 reported signs of physical dependence as a result of a specific follow-up visit 4 weeks after the end of the extension phase.
Maltese: 10 pazjenti oħrajn minn 176 irrappurtaw sinjali ta' dipendenza fiżika minħabba viżta għal follow-up speċifiku 4 ġimgħat wara t-tmiem tal-fażi ta' estensjoni.
English: Even using a very conservative statistical approach, the magnitude of effect (decrease in mean IRLS of 5.9 points compared to placebo) was in line with or even slightly better than the results found in the placebo-controlled studies with dopamine agonists approved as first line treatment.
Maltese: Anki bl-użu ta' metodu statistiku konservattiv ħafna, id-daqs tal-effett (tnaqqis fil-medja ta' IRLS ta' 5.9 punti meta mqabbel ma' plaċebo) kien konformi ma' jew anki ftit aħjar mir-riżltati misjuba fl-istudji kkontrollati bi plaċebo b'agonisti ta' dopamina approvati bħala kura tal-ewwel linja.
English: During the CMD(h) referral procedure, the proposed restless legs syndrome indication was restricted to “second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy".
Maltese: Waqt il-proċedura ta' riferenza CMD(h), lindikazzjoni proposta ta' sindromu ta' riġlejn irrekwieti ġiet ristretta għal “kura tat-tieni linja ta' pazjenti b'sindromu ta' riġlejn irrekwieti sever sa sever ħafna wara falliment ta' terapija dopaminerġika".
English: On 31 August 2012, the MAH submitted a type II variation via the mutual recognition procedure (MRP) for Oxynal and Targin and associated names, to request the inclusion of “symptomatic treatment of patients with moderate to severe idiopathic restless legs syndrome insufficiently treated with dopaminergic therapy”.
Maltese: Fil-31 ta' Awwissu 2012, id-detentur ippreżenta varjazzjoni ta' tip II permezz tal-proċedura ta' rikonoxximent reċiproku (MRP) għal Oxynal u Targin u ismijiet assoċjati, biex jitlob l-inklużjoni ta' “kura sintomatika ta' pazjenti b'sindromu idjopatiku ta' riġlejn irrekwieti moderat sa sever li ma ġewx ikkurati b'mod suffiċjenti b'terapija dopaminerġika”.
English: The CHMP acknowledged the methodological limitations of the open label study however the CHMP considered that reasonable justifications for maintenance of effect up to 52 weeks of treatment were provided by the MAH.
Maltese: Is-CHMP għaraf il-limitazzjonijiet metodoloġiċi tal-istudju open label, madankollu is-CHMP ikkunsidra li d-detentur ipprovda ġustifikazzjonijiet raġonevoli għaż-żamma tal-effett sa 52 ġimgħa ta' kura.
English: • The Committee considered that the amendments to the product information are appropriate to mitigate the risks of iatrogenic drug dependence, drug abuse or misuse, augmentation, tolerance and psychological dependence.
Maltese: • Il-Kumitat ikkunsidra li l-emendi lill-informazzjoni tal-prodott hija xierqa biex tnaqqas ir-riskji ta' dipendenza jatroġenika fuq il-mediċini, abbuż jew użu ħażin ta' mediċini, awmentazzjoni, tolleranza u dipendenza psikoloġika.
English: Further caution is included in the section 4.4 of the SmPC when OXN PR is administered to elderly irrespective of the indication.
Maltese: Aktar kawtela hija inkluża f'sezzjoni 4.4 tal-SmPC meta OXN PR jingħata lill-anzjani irrispettivament mill-indikazzjoni.
English: Warning regarding somnolence/sleep attacks and ability to drive/operating machinery has been added to the product information in accordance with the information given in the respective product information of dopaminergic substances approved in the RLS indication.
Maltese: Twissija fir-rigward ta' somnolenza/attakki ta' rqad u kapaċità ta' sewqan/tħaddim ta' makkinarju ġiet miżjuda malinformazzjoni tal-prodott skont l-informazzjoni li ngħatat fl-informazzjoni tal-prodott rispettiva ta' sustanzi dopaminerġiċi approvat fl-indikazzjoni tal-RLS.
English: The CHMP noted that the mean daily dose of OXN PR used in the extension phase was almost identical (and even slightly lower) compared to the mean daily dose used in the double-blind phase (18.12 mg vs. 22.62 mg), with no difference in mean doses in the extension phase between the subgroups previously treated with OXN PR or placebo.
Maltese: Is-CHMP innota li d-doża medja ta' kuljum ta' OXN PR użata fil-fażi ta' estensjoni kienet kważi identika (u saħansitra iktar baxxa) meta mqabbla mad-doża medja ta' kuljum użata fil-fażi double-blind (18.12 mg vs. 22.62 mg), b'ebda differenza fid-dożi medji fil-fażi ta' estensjoni bejn is-sottogruppi li ġew ikkurati qabel b'OXN PR jew bi plaċebo.
English: A detailed review of safety data from both the double-blind phase and extension phase (OXN3502/S) was conducted.
Maltese: Twettqet reviżjoni dettaljata tad-dejta ta' sigurtà kemm mill-fażi double-blind kif ukoll mill-fażi ta' estensjoni (OXN3502/S).
English: Overall, the CHMP considered that benefits of Oxynal and Targin and associated names in the sought indication outweigh the risks, taking into account the additional risk minimisations measures which had already been agreed at CMD(h) and the changes recommended to the product information.
Maltese: B'mod ġenerali, is-CHMP ikkunsidra li l-benefiċċji ta' Oxynal u Targin u ismijiet assoċjati fl-indikazzjoni mixtieqa jegħlbu r-riskji, filwaqt li jitqiesu l-miżuri addizzjonali ta' minimizzazzjoni tar-riskji li kien diġà sar qbil fuqhom f'CMD(h) u t-tibdiliet rakkomandati fl-informazzjoni tal-prodott.
English: The CHMP is of the opinion that the mean daily dose of 20mg/10mg oxycodone hydrochloride/naloxone used in the pivotal trial and being considerably lower than the doses needed in the pain indication should be mentioned in the SmPC to guide dosing.
Maltese: Is-CHMP huwa tal-opinjoni li d-doża medja ta' kuljum ta' 20mg/10mg oxycodone hydrochloride/naloxone użata fil-prova pivotali u billi hija ħafna aktar baxxa mid-dożi neċessarji fl-indikazzjoni tal-uġigħ, għandha tissemma' fl-SmPC biex tiggwida ddożaġġ.
English: As requested during the CMDh procedure, the applicant has further made a commitment to perform a drug utilisation study (DUS) and to update the risk management plan (RMP) subsequently to approval of the DUS in order to address concerns based on uncertainties that data of the clinical study including the long-term extension might not fully characterise a possible risk of tolerance, dependence and drug abuse in long-term use in IRLS.
Maltese: Kif mitlub waqt il-proċedura tas-CMDh, l-applikant għamel ukoll impenn li jwettaq studju tal-użu talmediċina (DUS) u li jaġġorna l-pjan ta' ġestjoni tar-riskju (RMP) wara approvazzjoni tad-DUS sabiex jiġi indirizzat it-tħassib ibbażat fuq inċertezzi li dejta tal-istudju kliniku inkluż l-estensjoni fit-tul jista' jkun ma jikkaratterizzawx għal kollox riskju possibbli ta' tolleranza, dipendenza u abbuż tal-mediċina fl-użu fit-tul f'IRLS.
English: Overall summary of the scientific evaluation of Oxynal and Targin and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Oxynal u Targin u ismijiet assoċjati (ara Anness I)
English: In addition, in order to further increase safety and appropriate use of OXN PR in the IRLS indication, the maximum daily dose has been limited to 60 mg/day.
Maltese: Barra minn hekk, sabiex ikomplu jiżdiedu s-sigurtà u l-użu xieraq ta' OXN PR fl-indikazzjoni IRLS, iddoża massima ta' kuljum ġiet limitata għal 60 mg/ġurnata.
English: OXN PR is currently indicated in “severe pain, which can be adequately managed only with opioid analgesics”.
Maltese: OXN PR bħalissa huwa indikat għal “uġigħ qawwi, li jista' jiġi ġestit b'mod adegwat b'analġeżiċi opjojdi biss”.
English: The CHMP considered that the data provided by the MAH are sufficient to support the use of Oxynal and Targin and associated names in the second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.
Maltese: Sejjer isir ukoll studju tal-użu tal-mediċina biex ikompli jikkaratterizza riskju possibbli ta' tolleranza, dipendenza u abbuż ta' mediċina f'użu fit-tul għal sindromu ta' riġlejn irrekwieti idjopatiku.
English: The review of ‘opioid dependence' revealed that during the extension phase two reports of withdrawal symptoms were obtained as part of the standard adverse event reporting procedures.
Maltese: Ir-reviżoni ta' ‘dipendenza b'opjojdi' żvelat li waqt il-fażi ta' estensjoni, inkisbu żewġ rapporti ta' sintomi ta' rtirar bħala parti minn proċedura ta' rappurtar standard ta' avvenimenti avversi.