FrancophonIA/ELRC3.0 huggingface dataset:
English: Suspension of the marketing authorisations should be lifted when bioequivalence to an EU Reference Medicinal Product has been established based on a bioequivalence study conducted visà-vis the EU Reference Medicinal Product.
Maltese: Is-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għandha titneħħa meta tkun ġiet stabbilita l-bijoekwivalenza ma' Prodott Mediċinali ta' Referenza tal-UE fuq il-ba¿i ta' studju ta' bijoekwivalenza mwettaq fir-rigward tal-Prodott Mediċinali ta' Referenza tal-UE.
English: The National Competent Authorities of Member States or Reference Member States if applicable, shall ensure that the following condition is fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istati Membri jew tal-Istati Membri ta' Referenza, jekk ikun applikabbli, għandhom ji¿guraw li l-MAH(s) jissodisfaw il-kundizzjonijiet li ġejjin:
English: Annex III Condition for lifting the suspension of the Marketing Authorisations
Maltese: Kundizzjoni għat-tneħħija tas-sospensjoni tal-Awtorizzazzjonijiet għatTqegħid fis-Suq
English: The full EPAR for Zinplava 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: Zinplava EMA/201086/2017
Maltese: EMA/201028/2017
English: In the second study, figures were 16% (62 out of 395) for Zinplava and 26% (97 out of 378) for placebo.
Maltese: Fit-tieni studju, il-figuri kienu ta' 16 % (62 minn 395) għal Zinplava u 26 % (97 minn 378) għallplaċebo.
English: The recommended dose is 10 mg per kilogram bodyweight.
Maltese: mg għal kull kilogramma tal-ġisem.
English: A new episode of diarrhoea was defined as 3 or more loose stools in 24 or fewer hours.
Maltese: Episodju ġdid ta' dijarea kien definit bħala 3 ippurgar maħlul jew aktar f'24 siegħa jew anqas.
English: Why is Zinplava approved?
Maltese: Għaliex ġie approvat Zinplava?
English: Other information about Zinplava
Maltese: Informazzjoni oħra dwar Zinplava
English: Zinplava has been shown to be effective at preventing recurrence of C. difficile infection, particularly in patients at high risk of the infection coming back (which occurs in about 15 to 35% of cases and is particularly difficult to treat).
Maltese: Intwera li Zinplava huwa effettiv biex jipprevjeni r-rikorrenza ta' infezzjoni b'C. difficile, partikolarment f'pazjenti li jinsabu f'riskju għoli li tirritorna l-infezzjoni (li sseħħ f'madwar 15 sa 35 % tal-każijiet u li hi partikolarment diffiċli biex tiġi kkurata).
English: Zinplava given during antibiotic treatment was shown to be more effective than placebo (a dummy treatment) at preventing a new episode of diarrhoea caused by C. difficile infection in 2 main studies involving a total of 2,655 patients.
Maltese: F'2 studji ewlenin li involvew total ta' 2,655 pazjent, intwera li Zinplava mogħti matul kura antibijotika huwa aktar effettiv mill-plaċebo (kura finta) biex jipprevjeni episodju ġdid ta' dijarea kkawżat minn infezzjoni bi C. difficile.
English: Zinplava bezlotoxumab
Maltese: Sommarju tal-EPAR għall-pubbliku bezlotoxumab
English: In the first study, 17% of patients given Zinplava (67 out of 386) had a new episode of diarrhoea in the 12 weeks after treatment compared with 28% of patients given placebo (109 out of 395).
Maltese: Fl-ewwel studju, 17 % tal-pazjenti li ngħataw Zinplava (67 minn 386) kellhom episodju ġdid ta' dijarea fit-12-il ġimgħa wara l-kura, meta mqabbel ma' 28 % tal-pazjenti li ngħataw il-plaċebo (109 minn 395).
English: Bezlotoxumab is a monoclonal
Maltese: Bezlotoxumab huwa antikorp monoklonali (tip ta
English: The most common side effects with Zinplava (seen in more than 4 in 100 patients) are nausea (feeling sick), diarrhoea, fever and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Zinplava (li dehru f'aktar minn 4 minn kull 100 pazjent) huma dardir (tħossok ma tiflaħx), dijarea, deni u uġigħ ta' ras.
English: Zinplava is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Maltese: Zinplava jiġi bħala konċentrat biex isir soluzzjoni għall-infużjoni (dripp) ġo vina.
English: Zinplava is generally well tolerated with side effects similar to those observed in patients on placebo.
Maltese: Zinplava ġeneralment jiġi ttollerat tajjeb b'effetti sekondarji simili għal dawk li ġew osservati f'pazjenti fuq il-plaċebo.
English: Zinplava is a medicine used in adults who have infections due to bacteria called Clostridium difficile that cause severe diarrhoea.
Maltese: Zinplava huwa mediċina li jintuża fl-adulti li jkollhom infezzjonijiet minħabba batterji msejħa Clostridium difficile li jikkawżaw dijarea severa.
English: Similar effects have been seen in patients on placebo.
Maltese: F'pazjenti fuq il-plaċebo, dehru effetti simili.
English: What are the risks associated with Zinplava?
Maltese: X'inhuma r-riskji assoċjati ma' Zinplava?
English: For the full list of all side effects and restrictions with Zinplava, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Zinplava, ara l-fuljett ta' tagħrif.
English: This is a summary of the European public assessment report (EPAR) for Zinplava.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta
English: How does Zinplava work?
Maltese: Kif jintuża Zinplava?
English: The effect was mainly seen in patients at higher risk of C. difficile infection coming back (such as older patients or those with a weakened immune system).
Maltese: L-effett deher primarjament f'pazjenti li jinsabu f'riskju ogħla li tirritorna infezzjoni bi C. difficile (bħal pazjenti ikbar fl-età jew dawk b'sistema immuni li ddgħajfet).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Zinplava's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għaldaqstant, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Zinplava huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: C. difficile bacteria produce toxins that damage the lining of the gut causing diarrhoea which may be severe.
Maltese: -batterji (spori) jistgħu jippersistu filġisem u eventwalment jipproduċu aktar tossini, u b'hekk jikkawżaw li jirritornaw is-sintomi.
English: 21 October 2010
Maltese: 21 ta' Ottubru 2010
English: The full European Public Assessment Report for Intrinsa can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Il-verżjoni sħiħa tar-Rapport ta' Valutazzjoni Pubblika Ewropew għal Intrinsa tinsab fuq is-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The patch releases 300 micrograms of the active substance testosterone over 24 hours.
Maltese: Ir-roqgħa terħi 300 mikrogramma tas-sustanza attiva testosteronu tul 24 siegħa.
English: The application was withdrawn after ‘day 90'.
Maltese: L-applikazzjoni ġiet irtirata wara l-‘jum 90'.
English: What is Intrinsa?
Maltese: X'inhu Intrinsa?
English: Intrinsa has been authorised since July 2006.
Maltese: Intrinsa ilu awtorizzat minn Lulju 2006.
English: The company presented results of four studies in a total of 2,245 women with HSDD.
Maltese: Il-kumpanija ppreżentat ir-riżultat ta' erba' studji li saru f'total ta' 2,245 mara bid-disturb HSDD.
English: The active substance in Intrinsa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Maltese: Is-sustanza attiva f'Intrinsa, it-testosteronu, hija ormon sesswali naturali prodott fl-irġiel u, sa ċertu punt, fin-nisa.
English: On 22 September 2010, Warner Chilcott Pharmaceuticals UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Intrinsa, to extend treatment to all postmenopausal women with hypoactive sexual desire disorder.
Maltese: Warner Chilcott Pharmaceuticals UK Limited innotifikat uffiċjalment lillKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal bidla fl-awtorizzazzjoni għat-tqegħid fis-suq għal Intrinsa sabiex testendi t-trattament għan-nisa kollha li kienu diġà għaddew il-menopawża u li jbatu mid-disturb ta' xewqa sesswali ipoattiva.
English: They were given either Intrinsa or placebo (a dummy treatment).
Maltese: Huma ngħataw Intrinsa jew plaċebo (trattament finta).
English: In postmenopausal women, Intrinsa was expected to release testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before the menopause.
Maltese: F'nisa li diġà għaddew il-menopawża, Intrinsa kien mistenni jerħi t-testosteronu mill-ġilda filfluss tad-demm sabiex jipproduċi livelli ta' testosteronu li jaqblu mal-livelli li kien hemm qabel ilmenopawża.
English: Intrinsa is a transdermal patch (a patch that delivers a medicine across the skin).
Maltese: Intrinsa huwa roqgħa trasdermika (roqgħa li tagħti l-mediċina minn ġol-ġilda).
English: What is happening with Intrinsa for its existing indication?
Maltese: Għal xiex kien mistenni jintuża Intrinsa?
English: How far into the evaluation was the application when it was withdrawn?
Maltese: F'xiex kienet waslet il-valutazzjoni meta ġiet irtirata?
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Maltese: L-ittra mill-kumpanija li tinnotifika lill-Aġenzija bl-irtirar tal-applikazzjoni hija disponibbli taħt it-tab ‘Iddokumenti kollha'.
English: What was the recommendation of the CHMP at that time?
Maltese: X'kien irrakkomanda s-CHMP dak iż-żmien?
English: These women will also be receiving treatment with an oestrogen (a female sex hormone).
Maltese: Dawn in-nisa ser jirċievu wkoll kura bl-estroġenu (ormon sesswali femminili).
English: It is already used to treat women with hypoactive sexual desire disorder (HSDD, a lack of sexual thoughts and sexual desire) who have had their womb and both ovaries surgically removed.
Maltese: Dan diġà qed jintuża biex jikkura nisa li jbatu mid-disturb ta' xewqa sesswali ipoattiva (HSDD, nuqqas ta' ħsibijiet u ta' xewqat sesswali) u li tneħħewlhom il-ġuf u żżewġ ovarji b'intervent kirurġiku.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated two lists of questions.
Maltese: Dan ifisser li s-CHMP ivvaluta d-dokumentazzjoni pprovduta mill-kumpanija u fassal żewġ listi ta' mistoqsijiet.
English: Based on the review of the data and the company's response to the CHMP's lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Intrinsa could not have been approved for use in all postmenopausal women who have HSDD.
Maltese: Abażi tal-valutazzjoni tad-dejta u tar-risposti li tat il-kumpanija għal-listi ta' mistoqsijiet mis-CHMP, fi żmien l-irtirar is-CHMP kellu xi tħassib u kien tal-opinjoni proviżorja li Intrinsa ma setax jiġi approvat sabiex jintuża fin-nisa kollha bl-HSDD li għaddew mill-menopawża.
English: Low testosterone levels have been linked to low sexual desire and to reduced sexual thoughts and arousal.
Maltese: Ġie rrikonoxxut li livelli baxxi ta' testosteronu jikkawżaw xewqa sesswali baxxa u tnaqqis fil-ħsibijiet u fl-eċċitament sesswali.
English: Ref. EMEA/CHMP/191900/2009 EMEA/H/A-29/1096
Maltese: EMEA/189577/2009 EMEA/H/A-29/1096
English: London, 17 March 2009 Doc.
Maltese: Londra, 17 ta' Marzu 2009 Dok ta' Ref.
English: 1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Maltese: 1 Artikolu 29 tad-Direttiva 2001/83/KE kif emendat, referenza abbażi ta' riskju potenzjali serju għas-saħħa pubblika
English: The company wanted the authorisation to be granted in Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Estonia, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovakia, Slovenia and Spain (the concerned Member States).
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni tingħata flAwstrija, fil-Belġju, fil-Bulgarija, fir-Repubblika Ċeka, fid-Danimarka, fl-Estonja, fi Franza, filĠermanja, fl-Italja, fil-Latvja, fil-Litwanja, fil-Lussemburgu, fin-Norveġja, fil-Polonja, fil-Portugall, fis-Slovakkja, fis-Slovenja u fi Spanja (l-Istati Membri kkonċernati).
English: What is Bleomycin?
Maltese: X'inhu Bleomycin?
English: The review was carried out under an ‘Article 29' referral1 procedure.
Maltese: Ir-reviżjoni saret skont proċedura ta' referenza tal-‘Artikolu 29'1.
English: Pharmachemie BV submitted a Marketing Authorisation Application for Bleomycin powder for solution for injection 15 U/vial in the decentralised procedure on 10 July 2007, the Netherlands acting as the reference member state.
Maltese: Pharmachemie BV issottomettiet Applikazzjoni għat-Tqegħid fis-Suq għal Bleomycin trab għal soluzzjoni għall-injezzjoni 15 U/kunjett fil-proċedura deċentralizzata fl-10 ta' Lulju 2007, bl-Olanda taġixxi bħala l-Istat Membru ta' referenza.
English: Why was Bleomycin reviewed?
Maltese: Għaliex ġie rivedut Bleomycin?
English: Questions and answers on the referral for Bleomycin, powder for solution for injection, 15 U/Vial, from Pharmachemie BV
Maltese: Mistoqsija u tweġiba dwar ir-referenza għal Bleomycin, trab għal soluzzjoni għall-injezzjoni, 15 U/Kunjett, minn Pharmachemie BV
English: On 3 November 2008, the Netherlands medicines regulatory agency, the Medicines Evaluation Board, referred the matter to the CHMP.
Maltese: Fit-3 ta' Novembru 2008, l-aġenzija regulatorja tal-mediċini Olandiża, il-Bord tal-Evalwazzjoni tal-Mediċini, irreferiet il-kwistjoni lis-CHMP.
English: Bleomycin is an anti-cancer medicine used to treat certain forms of cancer of the head or the neck, cervix (the neck of the womb) and external sexual organs; certain forms of lymphoma (cancer of the lymphatic system) such as Hodgkin's disease; and to treat cancer of the testicles.
Maltese: Bleomycin huwa mediċina kontra l-kanċer użat għat-trattament ta' ċerti forom ta' kanċer tar-ras jew tal-għonq, taċ-ċerviċi (l-għonq tal-utru) u tal-organi sesswali esterni; ċerti forom ta' linfoma (kanċer tas-sistema linfatika) bħalma hija l-marda ta' Hodgkin; u għat-trattament tal-kanċer tat-testikoli. Bleomycin jista' jintuża wkoll permezz ta' injezzjoni direttament ġol-kavità tas-sider għat-trattament talakkumulu ta' fluwidu fil-pulmun dovut għal kanċer.
English: Based on evaluation of the currently available data, including published literature and current treatment guidelines, and the scientific discussion within the Committee, the CHMP concluded that the benefits of Bleomycin injection, from Pharmachemie BV, outweigh its risks, and therefore the marketing authorisation for Bleomycin should be granted in all concerned member states.
Maltese: Abbażi tal-evalwazzjoni tad-dejta disponibbli fil-preżent, inkluż letteratura ppubblikata u l-linji gwida ta' trattament attwali, u d-diskussjoni xjentifika fi ħdan il-Kumitat, is-CHMP kkonkluda li l-benefiċċji ta' Bleomycin injezzjoni, minn Pharmachemie BV, huma akbar mir-riskji tiegħu, u għaldaqstant lawtorizzazzjoni għat-tqegħid fis-suq għal Bleomycin għandha tingħata fl-Istati Membri kkonċernati kollha.
English: The European Commission issued a decision on 12 March 2009.
Maltese: Il-Kummissjoni Ewropea adottat deċiżjoni fit-12 ta' Marzu 2009.
English: The CHMP assessed the available data in order to establish whether the two indications can be supported.
Maltese: Is-CHMP vvaluta d-dejta disponibbli sabiex jistabbilixxi jekk jistgħux jiġu sostnuti ż-żewġ indikazzjonijiet.
English: The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Bleomycin injection, from Pharmachemie BV.
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMEA) temmet proċedura ta' referenza wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea fir-rigward tal-awtorizzazzjoni tal-mediċina Bleomycin injezzjoni, minn Pharmachemie BV.
English: The indications ‘head and neck carcinoma' and ‘epidermoid carcinoma of external genitalia such as penile carcinoma, or cervix' had been deleted from the authorised indications for all bleomycin-containing products in Germany because the balance of benefit/risk for bleomycin in these indications was considered negative.
Maltese: L-indikazzjonijiet ‘karċinoma tar-ras u tal-għonq' u ‘karċinoma epidermojde talġenitali esterni bħall-karċinoma tal-pene jew taċ-ċerviċi' kienu tneħħew mill-indikazzjonijiet awtorizzati għall-prodotti kollha li fihom bleomycin fil-Ġermanja minħabba li l-bilanċ ta' benefiċċju/riskju għal bleomycin f'dawn l-indikazzjonijiet kien ikkunsidrat bħala wieħed negattiv.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Bleomycin injection, from Pharmachemie BV, outweigh its risks, and the marketing authorisation can be granted in the Member States of the European Union and the European Economic Area.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) talAġenzija kkonkluda li l-benefiċċji ta' Bleomycin injezzjoni, minn Pharmachemie BV, huma akbar mir-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fl-Istati Membri tal-Unjoni Ewropea u fiż-Żona Ekonomika Ewropea.
English: Bleomycin can also be used by injection directly inside the chest cavity to treat fluid accumulation in the lungs as a result of cancer.
Maltese: Bleomycin jintuża kważi dejjem f'kombinazzjoni ma' pilloli kontra l-kanċer jew f'kombinazzjoni marradjazzjoni.
English: London, September 2008 EMEA/436209/2008
Maltese: Londra, 26 ta' Settembru 2008 EMEA/436209/2008
English: EMEA/436209/2008
Maltese: EMEA/436209/2008-MT
English: Oral explanations were provided on 15 July 2008 and the CVMP Opinion was adopted on 16 July 2008.
Maltese: Ingħataw spjegazzjonijiet orali fil-15 ta' Lulju 2008 u l-Opinjoni tas-CVMP kienet adottata fis-16 ta' Lulju 2008.
English: The CVMP Opinion was adopted on 16 July 2008 and the subsequent Commission Decision adopted on 26 September 2008.
Maltese: L-opinjoni tas-CVMP ġiet adottata fis-16 ta' Lulju 2008 u d-Deċiżjoni sussegwenti tal-Kummissjoni ġiet adottata fis-26 ta' Settembru 2008.
English: SOLACYL 100 %, powder for oral solution for calves and pigs 4.2 Indications for use, specifying the target species Calves: supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g. anti-infective) therapy if necessary.
Maltese: SOLACYL 100 %, trab għal soluzzjoni orali għall-għoġiela u l-ħnieżer 4.2 Indikazzjonijiet għall-użu tal-prodott li jispeċifikaw l-ispeċi li fuqhom se jintuża l-prodott Għoġiela: trattament ta' appoġġ għal deni f'mard respiratorju akut, f'kombinazzjoni ma' terapija (ngħidu aħna anti-infettiva) addattata jekk meħtieġa.
English: OPINION FOLLOWING AN ARTICLE 35 REFERRAL FOR SODIUM SALICYLATE
Maltese: GĦALL-UŻU VETERINARJU OPINJONI WARA RIFERIMENT GĦALL-ARTIKOLU 35 KIF EMENDAT GĦAL SALIĊILAT TAS-SODJU
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Maltese: KUMITAT GĦALL-PRODOTTI MEDIĊINALI
English: The dosage required for calves is however 40 mg/kg bodyweight.
Maltese: Id-dożaġġ meħtieġ għall-għoġiela madankollu huwa 40 mg/kg piż tal-ġisem.
English: • The benefit/risk balance of the product was shown to be positive, however in young animals, the summary of Product Characteristics should state that the product is not to be used in neonates or very young calves of less than 2 weeks of age nor in piglets of less than 4 weeks of age.
Maltese: • Il-bilanċ ta' riskju/benefiċċju tal-prodott intwera li huwa pożittiv, madankollu f'annimali ta' età żgħira, is-Sommarju tal-Karatteristiċi tal-Prodott għandu jiddikjara li l-prodott la għandu jintuża fi frieħ li jkunu għadhom kif twieldu jew f'għoġiela ta' età żgħar ħafna ta' età inqas minn ġimagħtejn u lanqas fi driefeġ iżgħar minn 4 ġimgħat.
English: • Therapeutic concentrations are established and maintained following oral use of sodium salicylate in calves and pigs.
Maltese: • il-konċentrazzjonijiet terapewtiċi huma stabbiliti u miżmumin wara l-użu orali tas-saliċilat tassodju fl-għoġiela u l-ħnieżer.
English: • The efficacy of sodium salicylate as supportive treatment when given to calves and pigs was demonstrated in respiratory infections and the usefulness of this compound was clear for the treatment of inflammation in combination with concurrent antibiotic therapy.
Maltese: • L-effikaċja tas-saliċilat tas-sodju bħala trattament ta' appoġġ meta mogħti lill-għoġiela u l-ħnieżer intweriet f'infezzjonijiet respiratorji u l-utilità ta' din it-taħlita kienet ċara għat-trattament ta' infjammazzjoni f'kombinazzjoni ma' terapija antibijotika fl-istess ħin.
English: --1Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56 104.7 - 6.5 CCID50* *Cell culture infectious dose 50%
Maltese: --1 Virus sinktjali respiratorju bovin ħaj attenwat (BRSV, Bovine Respiratory Syncytial Virus - Virus Sinktjali Respiratorju Bovin), razza Lym-56 104.7 - 6.5 CCID50* *Doża infettuża tal-kultura taċ-ċelloli 50%
English: 20 mg
Maltese: 20 mg kunjett 1
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru tal-UE Isem (ivvintat) Qawwa Għamla Farmaċewtika Mod ta᾽ kif għandu jingħata
English: Intravenous use vial (glass)
Maltese: Għall-użu ġol vina kunjett (ħġieġ)
English: General characteristics of the active substance Absorption
Maltese: Karatteristiċi ġenerali tas-sustanza attiva Assorbiment
English: Date of first authorisation: 16 September 1998 Date of latest renewal: 3 September 2008
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Settembru 1998 Data tal-aħħar tiġdid: 3 ta' Settembru 2008
English: EU/1/98/082/001 30 film-coated tablets EU/1/98/082/002 60 film-coated tablets EU/1/98/082/003 100 film-coated tablets EU/1/98/082/005 175 film-coated tablets
Maltese: EU/1/98/082/001 30 pillola miksija b'rita EU/1/98/082/002 60 pillola miksija b'rita EU/1/98/082/003 100 pillola miksija b'rita EU/1/98/082/005 175 pillola miksija b'rita
English: What Comtess contains - The active substance is entacapone.
Maltese: X'fih Comtess - Is-sustanza attiva hi entacapone.
English: The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtess.
Maltese: Id-doża massima rrakkomandata hija ta' 10 pilloli kuljum, i.e. 2,000 mg ta' Comtess.
English: Yellow iron oxide (E 172) Red iron oxide (E 172) Titanium dioxide (E 171)
Maltese: Iron oxide isfar (E172) Iron oxide aħmar (E172) Titanium Dioxide (E171)
English: Do not take Comtess
Maltese: Tiħux Comtess
English: Other medicines and Comtess
Maltese: Mediċini oħra u Comtess
English: comtess 200 mg [carton only]
Maltese: comtess 200 mg [kartuna biss]
English: Comtess contains soya lecithin Comtess contains soya lecithin.
Maltese: Comtess fih soya lecithin Comtess fih soya lecithin.
English: Comtess contains soya lecithin.
Maltese: Comtess fih soya lecithin.
English: White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP) closures containing 30, 60, 100 or 175 tablets.
Maltese: Fliexken bojod magħmulin minn polyethylene ta' densità għolja (HDPE - high-density polyethylene) b'tappijiet bojod tal-polypropylene (PP) reżistenti għat-tbagħbis li jkun fihom 30, 60, 100 jew 175 pillola.
English: Comtess aids levodopa in relieving the symptoms of Parkinson's disease.
Maltese: Comtess jgħin lil levodopa fis-serħan tas-sintomi tal-marda ta' Parkinson.
English: There are large intra- and interindividual variations in the absorption of entacapone.
Maltese: Hemm differenzi intra u interindividwali kbar fl-assorbiment ta' entacapone.