FrancophonIA/ELRC3.0 huggingface dataset:
English: The review concluded that a small increase in the absolute risk for hepatotoxic reactions associated with nimesulide cannot be excluded although the overall risk benefit/balance remains positive.
Maltese: Ir-reviżjoni kkonkludiet li żieda żgħira fir-riskju assolut għal reazzjonijiet epatotossiċi assoċjati ma' nimesulide ma setgħetx tiġi eskluża iżda l-bilanċ ġenerali bejn il-benefiċċji u r-riskji jibqa' wieħed pożittiv.
English: Conditions of the Marketing Authorisations are identified in Annex IV of this Opinion.
Maltese: IV ta' din id-Deċiżjoni.
English: Nimesulide was the subject of an Article 31 referral to the CHMP in 2002, following national suspension of its licence in Finland, and subsequently Spain, due to concerns regarding hepatotoxicity.
Maltese: Il-prodotti mediċinali li fihom Nimesulide jinsabu attwalment fis-suq f'iktar minn 50 pajjiż madwar id-dinja, b'mod partikolari ġewwa l-Ewropa u l-Amerka t'Isfel.
English: The CHMP agreed, that the risk minimisation measures adopted at the end of the first referral have been able to contain the incidence of the most serious liver injuries.
Maltese: - Id-deċiżjoni li jiġi preskritt nimesulide għandha tkun ibbażata fuq evalwazzjoni tar-riskji ġenerali relatati mal-pazjenti individwali.
English: Having reviewed all available data on hepatotoxicity, the CHMP concluded the following.
Maltese: Wara li rriveda d-dejta kollha disponibbli dwar l-epatotossiċità, is-CHMP ikkonkluda dan li ġej.
English: The CHMP considered the gastrointestinal toxicity profile of nimesulide as compared to other
Maltese: Nimesulide wera iktar każijiet minn kull prodott mediċinali ieħor.
English: For N-nitrosodimethylamine (NDMA) and N nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance: 1) Limits for NDMA and NDEA outlined below should be implemented for a transitional period of 2 years:
Maltese: Għal N-nitrosodimethylamine (NDMA) u N nitrosodiethylamine (NDEA) il-MAH għandu jintroduċi l-ispeċifikazzjonijiet li ġejjin għas-sustanza tal-mediċina:
English: For all N-nitrosamines the MAH must ensure a control strategy is in place in drug substance batches used for their drug products.
Maltese: Għan-N-nitrosamini kollha, il-MAH għandu jiżgura li tiġi stabbilita strateġija ta' kontroll f'lottijiet ta' sustanzi mediċinali użati għall-prodotti mediċinali tagħhom.
English: Conditions to the MA
Maltese: NDMA
English: Candesartan 32 * These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected.
Maltese: Candesartan 32 * Dawn il-limiti mhumiex applikabbli għal lottijiet fejn aktar minn wieħed mill
English: 1 pre-filled pen + 7 NovoFine needles
Maltese: Kontenut Daqs tal-pakkett pinna 1 mimlija għal-lest + 7 labar NovoFine pinna 1 mimlija għal-lest + 7 labar NovoTwist
English: 1 pre-filled pen + 7 NovoTwist needles
Maltese: Mnejn jingħata
English: Urokinase is used for the lysis of blood clots in the following conditions: thrombosed intravascular catheters and cannulae; extensive acute proximal deep vein thrombosis; acute massive pulmonary embolism and acute occlusive peripheral arterial disease with limb threatening ischemia.
Maltese: Urokinase jintuża għal-liżi ta' emboli tad-demm filkondizzjonijiet li ġejjin: kateters u kannuli intravaskulari trombozizzati; trombożi fil-vini fil-fond prossimali akuta estensiva; emboliżmu pulmonari massiv akut u marda arterjali periferali okklużiva akuta b'iskemija ta' periklu għad-dirgħajn/għar-riġlejn.
English: The UK therefore triggered a referral under Article 29(4) of Directive 2001/83/EC.
Maltese: Għalhekk ir-Renju Unit skatta riferiment skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE.
English: Urokinase is a serine protease that catalyses conversion of plasminogen to plasmin with resultant fibrinolytic and thrombolytic properties.
Maltese: Urokinase huwa proteażi serina li tikkatalizza l-konverżjoni ta' plasminoġen għall-plasmina bir-riżultat ta' karatteristiċi fibrinolitiċi u trombolitiċi.
English: Urokinase is considered to have a well-established use in the above indications within the European Union and on 29 September 2006, Syner-Kinase was granted a marketing authorisation in the UK according to Article 10(a) of Directive 2001/83/EC.
Maltese: Urokinase jitqies bħala li għandu użu stabbilit sew fl-indikazzjonijiet ta' hawn fuq fl-Unjoni Ewropea u fid-29 ta' Settembru 2006, Syner-Kinase ngħata awtorizzazzjoni għat-tqegħid fis-suq fir-Renju Unit skont l-Artikolu 10(a) tad-Direttiva 2001/83/KE.
English: In January 2018, Syner-Medica Ltd sumitted a mutual recognition application for Syner-Kinase 10,000 IU, 25,000 IU, 100,000 IU, 250,000 IU and 500,000 IU powder for solution for injection or infusion in France, Germany, Spain and the Netherlands with the United Kingdom as the reference Member State (RMS).
Maltese: IU u 500,000 IU trab għal soluzzjoni għall-injezzjoni jew infużjoni fi Franza, fil-Ġermanja, fi Spanja u fin-Netherlands bir-Renju Unit bħala l-Istat Membru ta' referenza (RMS).
English: The mutual recognition procedure was closed on day 90, with the four concerned Member States raising potential serious risk to public health (PSRPH) in relation to the lack of bridging data between the product applied for and the product(s) described in literature that was used to demonstrate the benefit/risk of Syner-Kinase, the adventitious agent safety with respect to viral and prion clearance and the lack of adequate quality of the process validation of the semi-purified urokinase and lifetime of columns used for urokinase purification.
Maltese: Il-proċedura ta' rikonoxximent reċiproku ngħalqet f'jum 90, bl-erba' Stati Membri kkonċernati li qajmu riskju serju potenzjali għas-saħħa tal-pubbliku (PSRPH) fir-rigward tan-nuqqas tal-konnessjoni taddata bejn il-prodott li saret l-applikazzjoni għalih u l-prodott(i) deskritt(i) fil-letteratura li ntuża biex juri l-benefiċċju/ir-riskju ta' Syner-Kinase, is-sigurtà tal-aġent adventiv fir-rigward ta' tneħħija virali u prijonika u n-nuqqas ta' kwalità adegwata tal-validazzjoni tal-proċess ta' urokinase semippurifikat u ttul ta' ħajja ta' kolonni użati għall-purifikazzjoni ta' urokinase.
English: • The Committee concluded that manufacture of the semi-purified urokinase is adequately validated and controlled, and that reassurance has been provided that this intermediate is manufactured at a site that complies with the principles and guidelines of Good Manufacturing Practice (GMP).
Maltese: • Il-Kumitat ikkonkluda li l-manifattura ta' urokinase semippurifikat hija validata u kkontrollata b'mod adegwat, u li l-assigurazzjoni mill-ġdid ġiet ipprovduta li dan l-intermedju huwa mmanifatturat f'sit li jikkonforma mal-prinċipji u l-linji gwida ta' Prassi Tajba ta' Manifattura (PTM).
English: • The Committee concluded that the purification process of the active substance is suitable for the removal of possible viral and prion impurities.
Maltese: impuritajiet virali u prijoniċi possibbli.
English: Based on the data provided, it is considered that the comparability of Syner-Kinase and urokinase products used in the literature studies cited in the submission has been sufficiently demonstrated.
Maltese: Abbażi tad-data pprovduta, jitqies li l-komparabbiltà ta' Syner-Kinase u prodotti ta' urokinase użati flistudji tal-letteratura kkwotati fil-preżentazzjoni ntweriet biżżejjed.
English: • The Committee considered the totality of the data submitted by the MAH/applicant in relation to the objections raised as potential serious risk to public health.
Maltese: • Il-Kumitat ikkunsidra t-totalità tad-data sottomessa mill-MAH/applikant fir-rigward tal oġġezzjonijiet li tqajmu bħala riskju serju potenzjali għas-saħħa pubblika.
English: The MAH/applicant has successfully demonstrated that the virus removal/inactivation steps are appropriately controlled and will provide the final reports of the virus and TSE removal studies and the updated risk assessment analysis by 31 May 2019 to the relevant national competent authorities.
Maltese: L-MAH/applikant wera b'suċċess li l-istadji tat-tneħħija/l-attivazzjoni tal-virus huma kkontrollati b'mod xieraq u ser jipprovdi r-rapporti finali tal-virus u tal-istudji tat-tneħħija ta' TSE u l-analiżi talvalutazzjoni tar-riskju aġġornata sal-31 ta' Mejju 2019 lill-awtoritajiet nazzjonali kompetenti rilevanti.
English: The MAH/applicant has provided relevant data to justify the extrapolation of the data available in the literature on the benefit and risks of urokinase in the indications applied for.
Maltese: L-MAH/applikant ipprovda data rilevanti biex jiġġustifika l-estrapolazzjoni tad-data disponibbli filletteratura dwar il-benefiċċju u r-riskji ta' urokinase fl-indikazzjonijiet li saret l-applikazzjoni għalihom.
English: Finally, evidence has been provided that the manufacture of semi-purified urokinase is adequately validated and controlled and in compliance with good manufacturing practices and all concerns raised over the quality and manufacturing of Syner-Kinase are considered solved.
Maltese: Finalment, ġiet ipprovduta evidenza li l-manifattura ta' urokinase semippurifikat hija vvalidata b'mod adegwat u kkontrollata u f'konformità ma' prassi tajba ta' manifattura u t-tħassib kollu li qam dwar ilkwalità u l-manifattura ta' Syner-Kinase jitqies solvut.
English: • The Committee concluded that Syner-Kinase is comparable to the urokinase products mentioned in the published literature, and that the data available are adequate to support its proposed use.
Maltese: • Il-Kumitat ikkonkluda li Syner-Kinase huwa komparabbli għall-prodotti ta' urokinase msemmija fil letteratura ppubblikata, u li d-data disponibbli hija adegwata biex tappoġġja l-użu propost tagħha.
English: Finally, the CHMP requested the MAH/applicant to provide further information to demonstrate that the manufacturing steps for semi-purified urokinase have been satisfactorily validated, and also that the control strategy for column lifetime during the manufacture of the active pharmaceutical ingredient is suitable.
Maltese: Finalment, is-CHMP talab lill-MAH/applikant biex jipprovdi aktar informazzjoni biex juri li l-istadji tal-manifattura għal urokinase semippurifikat ġew validati b'mod sodisfaċenti, u wkoll li listrateġija tal-kontroll għat-tul ta' ħajja tal-kolonna waqt il-manifattura tal-ingredjent farmaċewtiku attiv hija xierqa.
English: The MAH/applicant has provided further comparative studies between Syner-Kinase active ingredient (API) and the API's in the urokinase products used in the literature studies cited in the submission, as well as data demonstrating the consistency of the product overtime despite the changes made to the product during its lifecycle.
Maltese: L-MAH/applikant ipprovda aktar studji komparattivi bejn l-ingredjent attiv (API) ta' Syner-Kinase u lAPI's fil-prodotti ta' urokinase użati fl-istudji tal-letteratura kkwotati fil-preżentazzjoni, kif ukoll data li turi l-konsistenza tal-prodott maż-żmien minkejja t-tibdil li sar fil-prodott waqt iċ-ċiklu tal-ħajja tiegħu.
English: The CHMP considered, as a consequence, that the benefit-risk balance of Syner-Kinase is favourable.
Maltese: B'konsegwenza, is-CHMP ikkunsidra, li l-bilanċ bejn il-benefiċċju u r-riskju ta' Syner-Kinase huwa favorevoli.
English: Overall summary of the scientific evaluation by the CHMP
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika mis-CHMP
English: A referral was thus triggered at the CMD(h) but at D60 of the procedure, the PSRPH issues remained unresolved.
Maltese: Għalhekk ġie skattat riferiment fisCMD(h) iżda f'D60 tal-proċedura, il-kwistjonijiet ta' PSRPH baqgħu ma ġewx riżolti.
English: Article 34 of Directive 2001/82/EC, as amended
Maltese: Artikolu 34 tad-Direttiva 2001/82/KE, kif emendat
English: 1 September 2014
Maltese: 1 ta' Settembru 2014
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Maltese: Enrofloxacin huwa sustanza kimoterapewtika sintetika mill-klassi tad-derivati ta' fluoroquinolone carboxylic-acid.
English: Written explanations were provided by the marketing authorisation holders on 17 June 2013, 10 January 2014 and 12 March 2014.
Maltese: Ġew ipprovduti spjegazzjonijiet bil-miktub middetenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fis-17 ta' Ġunju 2013, l-10 ta' Jannar 2014 u t-12 ta' Marzu 2014.
English: The Committee appointed M. Holzhauser-Alberti as rapporteur and C. Muñoz Madero as co-rapporteur.
Maltese: Holzhauser-Alberti bħala relatur u lil C. Muñoz Madero bħala korelatur.
English: Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names are solutions for injection containing enrofloxacin at 25 mg/ml, 50 mg/ml and 100 mg/ml respectively.
Maltese: Baytril 2.5% injettabbli, Baytril 5% injettabbli u Baytril 10% injettabbli u l-ismijiet assoċjati tagħhom huma soluzzjonijiet għall-injezzjoni li fihom enrofloxacin f'25 mg/ml, 50 mg/ml u 100 mg/ml rispettivament.
English: It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Maltese: Għandha attività antibatterika kontra firxa wiesgħa ta' batterji Gram-negattivi u Grampożittivi. Enrofloxacin huwa għall-użu veterinarju biss.
English: Opinion following an Article 341 referral for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names
Maltese: għal Baytril 2.5% injettabbli, Baytril 5% injettabbli u Baytril 10%
English: Due to divergent national decisions taken by Member States with respect to target species, indications, posology and withdrawal periods concerning the authorisations of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names, on 26 October 2012 France referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve the divergence in the product information of nationally authorised products across the European Union.
Maltese: Fis-26 ta' Ottubru 2012, minħabba deċiżjonijiet diverġenti meħudin mill-Istati Membri fir-rigward talispeċi fil-mira, l-indikazzjonijiet, il-pożoloġija u l-perjodi ta' tiżmim li jikkonċernaw l-awtorizzazzjonijiet ta' Baytril 2.5% injettabbli, Baytril 5% injettabbli u Baytril 10% injettabbli u l-ismijiet assoċjati tagħhom, Franza rreferiet il-kwistjoni lis-CVMP skont l-Artikolu 34(1) tad-Direttiva 2001/82/KE, biex issolvi d-diverġenza fl-informazzjoni dwar il-prodott ta' prodotti awtorizzati b'mod nazzjonali madwar lUnjoni Ewropea.
English: Opinion following an Article 340F referral for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names EMA/538940/2014
Maltese: injettabbli u Baytril 10% injettabbli u l-ismijiet assoċjati tagħhom EMA/538940/2014
English: The referral procedure started on 7 November 2012.
Maltese: Il-proċedura ta' riferiment bdiet fis-7 ta' Novembru 2012.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names remains positive, subject to amendments in the product information.
Maltese: Skont evalwazzjoni tad-dejta disponibbli fil-preżent, is-CVMP ikkunsidra li l-profil tal-benefiċċju-riskju ta' Baytril 2.5% injettabbli, Baytril 5% injettabbli u Baytril 10% injettabbli u l-ismijiet assoċjati tagħhom jibqa' pożittiv, soġġett għal emendi fl-informazzjoni dwar il-prodott.
English: The Committee adopted a positive opinion by majority on 9 April 2014.
Maltese: Il-Kumitat adotta opinjoni pożittiva b'maġġoranza fid-9 ta' April 2014.
English: 4.5% (0 h 35 min) CI95% 0.93%, 7.97%
Maltese: 4.5% (0 sigħat 35 min) CI95% 0.93%, 7.97%
English: • The active substance is entacapone.
Maltese: • Is-sustanza attiva hi entacapone.
English: 28 months.
Maltese: 28 xahar.
English: Week 8-24 66.8±14.5
Maltese: Ġimgħa 8-24 66.8±14.5
English: Entacapone (n=85) Placebo (n=86)
Maltese: Entacapone (n=85) Plaċebo (n=86)
English: TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen Hungary
Maltese: TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen L-Ungerija
English: Date of first authorisation: 18/02/2011 Date of latest renewal: 19/11/2015
Maltese: Data tal-ewwel awtorizzazzjoni:18/02/2011 Data tal-aħħar tiġdid: 19/11/2015
English: EU/1/10/665/002 - 60 tablets EU/1/10/665/003 - 100 tablets EU/1/10/665/004 - 175 tablets
Maltese: EU/1/10/665/002 - 60 pilloli EU/1/10/665/003 - 100 pilloli EU/1/10/665/004 - 175 pilloli
English: EU/1/10/665/001 - 30 tablets EU/1/10/665/002 - 60 tablets EU/1/10/665/003 - 100 tablets EU/1/10/665/004 - 175 tablets
Maltese: EU/1/10/665/001 - 30 pilloli EU/1/10/665/002 - 60 pilloli EU/1/10/665/003 - 100 pilloli EU/1/10/665/004 - 175 pilloli
English: Mogilska 80, 31-546, Krakow Poland
Maltese: Mogilska 80, 31-546, Krakow Il-Polonja
English: Österreich ratiopharm Arzneimittel VertriebsGmbHTel: +43/1/97007-0
Maltese: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43/1/97007-0
English: Mogilska 80, 31-546, Krakow, Poland
Maltese: Mogilska 80, 31-546, Krakow, Il-Polonja
English: Cellulose, microcrystalline Povidone
Maltese: Il-qalba tal-pillola Cellulose, microcrystalline Povidone
English: The INR values increased on average by 13% [CI90 6-19%].
Maltese: Il-valuri ta' l-INR żdiedu b'medja ta' 13% [CI90 6-19%].
English: The substance is subject to extensive first-pass metabolism.
Maltese: Is-sustanza hija suġġetta għall-metaboliżmu first-pass estensiv.
English: For the characteristics of NMS see Section 4 Possible side effects.
Maltese: Għall-karatteristiċi ta' NMS ara Sessjoni 4 Effetti sekondarji possibbli.
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Maltese: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, Ir-Renju Unit
English: The (E)-isomer accounts for 95% of the AUC of entacapone.
Maltese: L-iżomer (E) jikkonstitwixxi 95% tal-AUC ta' entacapone.
English: Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19) (see section
Maltese: Entacapone wera ftit jew l-ebda inibizzjoni ta' tipi oħra ta' iżoenzimi P450 (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A u
English: Cardiac disorders**
Maltese: Disturbi fil-qalb**
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu
English: • The other ingredients in the tablet core are cellulose microcrystalline, povidone, starch pregelatinised, magnesium stearate and in the film-coating are poly(vinyl alcohol), talc, titanium dioxide (E171), macrogol, iron oxide yellow (E172), lecithin (soya), iron oxide red (E172).
Maltese: • Is-sustanzi l-oħra fil-qalba tal-pillola huma cellulose microcrystalline, povidone, starch pregelatinised, magnesium stearate u fil-kisja tar-rita huma poly(vinyl alcohol), talc, titanium dioxide (E171), macrogol, iron oxide isfar (E172), lecithin (soya), iron oxide aħmar (E172).
English: Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
Maltese: Entacapone (n=103) Plaċebo (n=102)
English: Ischemic heart disease events other than myocardial infarction (e.g. angina pectoris)
Maltese: Episodji ta' mard tal-qalb iskemiku apparti infart mijokardijaku (eż. angina pectoris)
English: Reporting of side effects
Maltese: Rappurtar ta 'effetti sekondarji
English: Approximately 92% of the dose is eliminated during ß-phase with a short elimination half-life of 30 minutes.
Maltese: Madwar 92% tad-doża tiġi eliminata matul ilfazi-ß b'half-life tal-eliminazzjoni ta' 30 minuta.
English: Insomnia, hallucinations, confusion, paroniria
Maltese: Nuqqas ta' rqad, alluċinazzjonijiet, konfużjoni, ħolm eċċessiv
English: Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations slightly (5-10%) more than from standard levodopa/carbidopa preparations.
Maltese: Entacapone iżid il-bijodisponibilità ta' levodopa minn sustanzi standard ta' levodopa/benserazide, ftit (5-10%) aktar minn preparazzjonijiet standard ta' levodopa/carbidopa.
English: Clinical studies
Maltese: Studji Kliniċi
English: • if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS).
Maltese: • jekk qatt kellek reazzjoni rari għall-mediċini antipsikotiċi msejħa sindrome newrolettiku malinn (NMS).
English: However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18 % [CI90 11-26%].
Maltese: Madanakollu, fi studju dwar l-interazzjonijiet, li sar f'volontiera b'saħħithom, entacapone ma biddilx il-livelli fil-plażma ta' S-warfarin, waqt li l-AUC għal R-warfarin żdied b'medja ta' 18% [CI90 1126%].
English: Other medicines and Entacapone Teva
Maltese: Mediċini oħra u Entacapone Teva
English: In clinical studies the most common adverse reactions leading to discontinuation of entacapone treatment have been gastrointestinal symptoms (e.g. diarrhoea, 2.5%) and increased dopaminergic adverse reactions of levodopa (e.g. dyskinesias, 1.7%).
Maltese: Fi studji kliniċi l-aktar reazzjonijiet avversi komuni li wasslu għat-twaqqif tal-kura b'entacapone, kienu sintomi gastrointestinali (eż. dijarea, 2.5%) u żieda fir-reazzjonijiet avversi dopaminerġiċi ta' levodopa (eż. diskineżja, 1.7%).
English: - Concomitant use of a selective MAO-A inhibitor plus a selective MAO-B inhibitor and entacapone (see section 4.5).
Maltese: - L-użu ta' inibitur selettiv ta' MAO-A flimkien ma' inibitur selettiv ta' MAO-B u entacapone (ara sezzjoni 4.5).
English: The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Entacapone Teva.
Maltese: Id-doża massima rrakkomandata hija ta' 10 pilloli kuljum, i.e. 2,000 mg ta' Entacapone Teva.
English: Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors.
Maltese: Entacapone jagħmel parti minn klassi ġdida terapewtika, inibituri ta' catechol -O- methyltransferase (COMT).
English: Due to its affinity to cytochrome P450 2C9 in vitro (see section 5.2), entacapone may potentially interfere with medicinal products with metabolism dependent on this isoenzyme, such as S-warfarin.
Maltese: Minħabba l-affinità tiegħu għal cytochrome P450 2C9 in vitro (ara sezzjoni 5.2), entacapone jista' potenzjalment jinterferixxi ma' prodotti mediċinali b'metaboliżmu dipendenti fuq din l-iżoenzima, bħalma huwa S-warfarin.
English: Clinical interaction studies with diazepam and non-steroidal antiinflammatory medicinal products have not been carried out.
Maltese: diazepam u prodotti mediċinali anti-infjammatorji mhux sterojdi.
English: Entacapone is extensively bound to plasma proteins, mainly to albumin.
Maltese: Entacapone jintrabat b'mod estensiv mal-proteini tal-plażma, prinċipalment mal-albumina.
English: Pharmacotherapeutic group: other dopaminergic agents, ATC code: N04BX02.
Maltese: Kategorija farmakoterapewtika: aġenti dopaminerġiċi oħra, Kodiċi ATC:
English: However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catecholstructured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine, and paroxetine) is still limited.
Maltese: Madanakollu, l-esperjenza bl-użu kliniku ta' entacapone ma' diversi prodotti mediċinali, inklużi l-inibituri MAO-A, antidipressanti triċikliċi, inibituri li jinibixxu l-assorbiment mill-ġdid ta' noradrenaline bħal desipramine, maprotiline u venlafaxine u prodotti mediċinali li jiġu metabolizzati b'COMT (eż. sustanzi bl-istruttura ta' catechol: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamina, dobutamine, alpha-methyldopa, apomorphine u paroxetine), għadha limitata.
English: See section 4 Possible side effects for the characteristics of NMS;
Maltese: Ara sezzjoni 4 Effetti sekondarji possibbli għall-karatteristiċi ta' NMS;