FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of the fact that the Applicant/MAH proposed to support the efficacy of the P. multocida component with data from the field the Applicant/MAH was requested to clarify whether animals vaccinated with APPM Respipharm, competitor vaccine and unvaccinated controls had been housed together on each site, which could have allowed a valid comparison of the efficacy of the respective vaccines.
Maltese: Fid-dawl tal-fatt li l-Applikant/MAH ippropona li jsostni l-effikaċja tal-komponent ta' P. multocida b'informazzjoni mill-kamp, l-Applikant/MAH intalab jikkjarifika jekk l-annimali mlaqqma b'APPM Respipharm, vaċċin kompetitur jew kontrolli mhux imlaqqma kinux sistemati flimkien f'kull sit, li seta' jippermetti tqabbil validu tal-effikaċja tal-vaċċini rispettivi.
English: Whereas: - the CVMP considered that there are significant deficiencies in the data provided by the Applicant in support of the efficacy of the Pasteurella multocida serotype A component.
Maltese: Billi: - is-CVMP qies li hemm nuqqasijiet sinifikanti fl-informazzjoni pprovduta mill-Applikant b'appoġġ għall-effikaċja tal-komponent tal-Pasteurella multocida serotip A.
English: This was in part supported by the view that since P.multocida is a secondary infection that any possible benefits seen could equally well be attributed to a reduction of incidence of disease caused by the primary agent (A.pleuropneumoniae) afforded by vaccination against APP.
Maltese: Dan sa ċertu punt kien appoġġjat mill-fehma li billi lP.multocida hija infezzjoni sekondarja, kwalunkwe benefiċċju possibbli li deher seta' faċilment ikun attribwit għal tnaqqis fl-inċidenza tal-marda kkawżata mill-aġent primarju (A.pleuropneumoniae) faċilitat mit-tilqima kontra l-APP.
English: requirement was considered met by challenge studies with serotype 2 and 9.
Maltese: Eur. ġie kkunsidrat li ntlaħaq mill-istudji ta' sfida bis-serotipi 2 u 9.
English: The applicant provided field data, supplemented with bibliographical data, to indicate that P.multocida causes frequent co-infections with APP in pigs with respiratory disease.
Maltese: L-applikant ipprovda dejta prattika, issupplimentata b'informazzjoni biblijografika, biex juri li lP.multocida tikkawża ko-infezzjonijiet frekwenti bl-APP f'majjali li jkollhom mard respiratorju.
English: - the CVMP considered that these deficiencies are such that it is considered that no data have been provided in support of the efficacy of the P. multocida serotype A component.
Maltese: - is-CHMP qies li dawn in-nuqqasijiet huma tali li huwa kkunsidrat li ma ġiet ipprovduta l-ebda informazzjoni li tappoġġja l-effikaċja tal-komponent tal-P. multocida serotip A.
English: The Applicant/MAH provided the requested clarification, which confirmed the statistical analysis that had been applied.
Maltese: L-Applikant/MAH ipprovda l-kjarifika mitluba, li kkonfermat l-analiżi statistika li kienet ġiet applikata.
English: There were no details of the statistical methods used, nor were there full reports of the field trials.
Maltese: Ma kienx hemm dettalji tal-metodi statistiċi li ntużaw, u lanqas ma kien hemm rapporti tal-provi prattiċi.
English: There are two points for particular discussion, firstly that challenge has not been done with APP Serotype 11, and secondly that because efficacy of the P.multocida component is based principally on field data there are no information on the precise specifications of the batches used.
Maltese: Hemm żewġ punti għal diskussjoni partikolari, l-ewwel nett li l-isfida ma saritx bl-APP Serotip 11, u t-tieni peress li l-effikaċja tal-komponent tal-P.multocida hija bbażata prinċipalment fuq dejta prattika, m'hemm ebda informazzjoni dwar l-ispeċifikazzjonijiet eżatti tal-lottijiet użati.
English: The applicant has provided data which confirm that the APP serotypes contained within the product are present in the Member States involved.
Maltese: L-applikant ipprovda informazzjoni li tikkonferma li s-serotipi APP li hemm fil-prodott huma preżenti fl-Istati Membri involuti.
English: The Applicant/MAH provided information on the antigen content of the batches of vaccine used in the field studies.
Maltese: L-Applikant/MAH ipprovda informazzjoni dwar il-kontenut tal-antiġeni fil-lottijiet tal-vaċċin li ntużaw fl-istudji prattiċi.
English: The Note for Guidance on field trials with veterinary vaccines3 indicates “The environment in which the two groups of animals are housed shall be as equivalent as possible (i.e. same farm/barn/batch) or at least as similar as possible (e.g. same farm/different barn/same batch).” It was confirmed that according to the study protocol the groups of pigs vaccinated with the different vaccines had been housed at the same farm in different halls (barns) which is acceptable.
Maltese: In-Nota għal Gwida dwar provi prattiċi bil-vaċċini veterinarji3 tindika li “L-ambjent li fih jinżammu ż-żewġ gruppi ta' annimali għandu jkun ekwivalenti kemm jista' jkun (jiġifieri l-istess razzett/maqfel/lott) jew għallinqas simili kemm jista' jkun (eż. l-istess razzett/maqfel differenti/l-istess lott).”
English: It was noted that all three Apx toxigenic groups are represented in the vaccine.
Maltese: Ġie nnotat li t-tliet gruppi tossiġeniċi Apx kollha huma rappreżentati fil-vaċċin.
English: Consequently, there do not appear to be additional safety concerns relating to the levels of formaldehyde that may result from administration of product containing formaldehyde at the levels proposed.
Maltese: Għaldaqstant, ma jidhirx li hemm tħassib addizzjonali dwar is-sigurtà marbut mal-livelli ta' formaldehyde li jistgħu jirriżultaw mill-għoti ta' prodott li fih il-formaldehyde fil-livell proposti.
English: Strength
Maltese: Ir
English: The frequency of isolations of each organism in unvaccinated pigs provided some indication of the prevalence of the agent at the site and, taken in association with experience of pathology, could be considered to provide some support for the classification process.
Maltese: Il-frekwenza tal-iżolar ta' kull organiżmu f'majjali mhux imlaqqma pprovdiet xi indikazzjoni tal-prevalenza tal-aġent fil-post u, meqjusa flimkien mal-esperjenza tal-patoloġija, tista' tiġi kkunsidrata li tipprovdi xi appoġġ għallproċess ta' klassifikazzjoni.
English: The Applicant considers that the pathological changes seen in the lungs are different due to Actinobacillus pleuropneumoniae compared to Pasteurella multocida.
Maltese: L-Applikant iħoss li l-bidliet patoloġiċi li dehru fil-pulmuni huma differenti minħabba lActinobacillus pleuropneumoniae meta mqabbla mal-Pasteurella multocida.
English: Recommended dose
Maltese: Żero jiem
English: In particular the Applicant/MAH should clarify to what extent they could be considered to meet the criteria of minimum potency for P.multocida.
Maltese: B'mod partikolari, l-Applikant/MAH għandu jikkjarifika safejn dawn jistgħu jitqiesu li jissofisfaw il-kriterji tal-qawwa minima għall-P.multocida.
English: The analysis had looked at the frequency of mortality and lung confiscations at slaughter (indicative of the presence of lesions) caused by either APP or P.multocida in pigs vaccinated with APPM Respipharm.
Maltese: L-analiżi ħarset lejn il-frekwenza tal-mortalità u l-konfiska tal-pulmuni fil-mument tal-qatla (li tindika l-preżenza ta' leżjonijiet) kkawżati minn APP jew P.multocida f'majjali mlaqqma b'APPM Respipharm.
English: The Applicant/Marketing Authorisation Holder (MAH) had developed additional in-process tests to control antigen levels after inactivation.
Maltese: L-Applikant/Id-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq (MAH) kien żviluppa testijiet addizzjonali waqt il-proċess biex jikkontrolla l-livelli tal-antiġeni wara d-diżattivazzjoni.
English: The present referral follows an application for mutual recognition of the product in Poland and Spain.
Maltese: Irreferenza attwali ssegwi applikazzjoni għar-rikonoxximent reċiproku tal-prodott fil-Polonja u fi Spanja.
English: In addition, field data have been accumulated comparing the clinical outcome in pigs with respiratory disease on farms where APP and P.multocida are simultaneously present, and which have been vaccinated with either APPM Respipharm or a competitor product incorporating APP only.
Maltese: Barra minn hekk, ġiet akkumulata dejta prattika li pparagunat ir-riżultat kliniku f'majjali li kellhom mard respiratorju f'irziezet fejn l-APP u l-P.multocida huma preżenti fl-istess ħin, u li tlaqqmu jew b'APPM Respipharm jew bi prodott kompetitur li jinkorpora l-APP biss.
English: Concerning the absence of challenge with APP serotype 11, part of the applicant's view is that all three Apx groups are represented in the vaccine.
Maltese: Dwar in-nuqqas ta' sfida bl-APP serotip 11, parti mill-opinjoni tal-applikant hija li t-tliet gruppi
English: However, in view of the deficiencies in these data (see below) a justification for inclusion of PMA in the product could not be accepted.
Maltese: Madankollu, minħabba nnuqqasijiet f'din id-dejta (ara taħt), ġustifikazzjoni għall-inklużjoni ta' PMA fil-prodott ma setgħetx tiġi aċċettata.
English: Concerning the link to the efficacy of P.multocida the Applicant/MAH was requested to provide further information on the batches of vaccine used during the field studies and further clarification on the details of the studies sufficient to substantiate a claim for the efficacy of the P.multocida component.
Maltese: Minkejja r-riservi tal-kumitat rigward innuqqasijiet fl-istudji, ġie nnotat ukoll li l-Applikant/MAH ma kienx ipprovda informazzjoni li ssostni l-bidu u d-dewmien allegat tal-protezzjoni għal P. multocida.
English: This was considered important as pathological changes caused by P.multocida are not specific for infection with this organism.
Maltese: Dan tqies importanti billi l-bidliet patoloġiċi kkawżati minn P.multocida mhumiex speċifiċi għal infezzjoni b'dan l-organiżmu.
English: Date of first authorisation: 11 November 2013 Date of latest renewal: 8 June 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 11 ta' Novembru 2013 Data tal-aħħar tiġdid: 8 ġunju 2018
English: - The active substances of Corbilta are levodopa, carbidopa and entacapone.
Maltese: - Is-sustanzi attivi ta' Corbilta huma levodopa, carbidopa u entacapone.
English: Other medicines and Corbilta
Maltese: Mediċini oħra u Corbilta
English: Vascular disorders: Common:
Maltese: Disturbi vaskulari Komuni:
English: Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Corbilta may potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as S-warfarin.
Maltese: Minħabba l-affinità ta' entacapone għaċ-ċitokromju P450 2C9 in vitro (ara sezzjoni 5.2), Corbilta jista' potenzjalment jinterferixxi ma' sustanzi attivi bħal S-warfarin li l-metaboliżmu tagħhom jiddependi minn din l-iso-enzima.
English: Corbilta comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Maltese: Corbilta huwa disponibbli f'sitt daqsijiet ta' pakketti differenti (10, 30, 100, 130, 175 jew 250 pillola).
English: Corbilta contains sucrose
Maltese: Corbilta fih sucrose
English: Always leave at least an hour between Corbilta tablets, to avoid possible side effects.
Maltese: Dejjem ħalli mill-inqas siegħa bejn pilloli Corbilta, sabiex tevita effetti sekondarji possibbli.
English: corbilta 75/18.75/200 mg [carton only]
Maltese: corbilta 75/18.75/200 mg [kartuna biss]
English: - If you are taking Corbilta 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg,
Maltese: - Jekk qed tieħu pilloli ta' Corbilta 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg,
English: - Coadministration of Corbilta with non-selective monoamine oxidase (MAO-A and MAO-B)
Maltese: - Għoti fl-istess ħin ta' Corbilta ma' inibituri mhux selettivi ta' monoamine oxidase (MAO-A u
English: corbilta 125/31.25/200 mg [carton only]
Maltese: corbilta 125/31.25/200 mg [kartuna biss]
English: organizačná zložka Tel: +421 2 48 200 600
Maltese: Slovenská republika Sandoz d.d. organizačná zložka Tel: +421 2 48 200 600
English: Pyridoxine, however, is not effective in reversing the actions of Corbilta.
Maltese: Madankollu, Pyridoxine mhux effettiv biex jaqleb l-azzjonijiet ta' Corbilta.
English: corbilta 175/43.75/200 mg [carton only]
Maltese: corbilta 175/43.75/200 mg [kartuna biss]
English: corbilta 150/37.5/200 mg [carton only]
Maltese: corbilta 150/37.5/200 mg [kartuna biss]
English: The most frequently reported adverse reactions with Corbilta are dyskinesias occurring in approximately 19% of patients; gastrointestinal symptoms including nausea and diarrhoea occurring in approximately 15% and 12% of patients, respectively; muscle, musculoskeletal and connective tissue pain occurring in approximately 12% of patients; and harmless reddish-brown discolouration of urine (chromaturia) occurring in approximately 10% of patients.
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti b'Corbilta huma diskajneżji li jseħħu f'madwar 19% tal-pazjenti; sintomi gastro-intestinali inkluż tqalligħ u dijarea li jseħħu f'madwar 15% u 12% tal-pazjenti, rispettivament; uġigħ fil-muskoli, muskolu-skeletriku u tat-tessuti konnettivi li jseħħ f'madwar 12% tal-pazjenti; u bidla li ma tagħmilx ħsara fil-kulur tal-awrina għal lewn kannella fl-aħmar (kromaturja) li sseħħ f'madwar 10% tal-pazjenti.
English: corbilta 50/12.5/200 mg [carton only]
Maltese: corbilta 50/12.5/200 mg [kartuna biss]
English: - Corbilta may induce orthostatic hypotension.
Maltese: - Corbilta jista' jinduċi pressjoni ortostatika baxxa.
English: corbilta 100/25/200 mg [carton only]
Maltese: corbilta 100/25/200 mg [kartuna biss]
English: Corbilta 150 mg/37.5 mg/200 mg: brownish or greyish red, elongated-ellipse shaped, unscored filmcoated tablets marked with ‘LCE 150' on one side.
Maltese: Corbilta 150 mg/37.5 mg/200 mg: pilloli miskija b'rita, bla sinjal imnaqqax, ta' lewn aħmar fil-kannella jew fil-griż, b'forma ta' elissi mtawwla u mmarkati b'‘LCE 150' fuq naħa waħda.
English: Your doctor may take some regular laboratory tests during a long term treatment with Corbilta.
Maltese: It-tabib tiegħek jista' jagħmel xi testijiet tal-laboratorju regolari waqt kura fit-tul b'Corbilta.
English: Corbilta 50 mg/12.5 mg/200 mg film-coated tablets Corbilta 75 mg/18.75 mg/200 mg film-coated tablets Corbilta 100 mg/25 mg/200 mg film-coated tablets Corbilta 125 mg/31.25 mg/200 mg film-coated tablets Corbilta 150 mg/37.5 mg/200 mg film-coated tablets Corbilta 175 mg/43.75 mg/200 mg film-coated tablets Corbilta 200 mg/50 mg/200 mg film-coated tablets
Maltese: Corbilta 50 mg/12.5 mg/200 mg pilloli miksija b'rita Corbilta 75 mg/18.75 mg/200 mg pilloli miksija b'rita Corbilta 100 mg/25 mg/200 mg pilloli miksija b'rita Corbilta 125 mg/31.25 mg/200 mg pilloli miksija b'rita Corbilta 150 mg/37.5 mg/200 mg pilloli miksija b'rita Corbilta 175 mg/43.75 mg/200 mg pilloli miksija b'rita Corbilta 200 mg/50 mg/200 mg pilloli miksija b'rita
English: Tel: +386 1 580 21 11
Maltese: Lek Pharmaceuticals d.d. Tel: +386 1 580 21 11
English: corbilta 200/50/200 mg [carton only]
Maltese: corbilta 200/50/200 mg [kartuna biss]
English: Corbilta is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.
Maltese: Corbilta mhux irrakkomandat biex jintuża għall-kura ta' sintomi ekstrapiramidali (eż. movimenti involontarji, rogħda, riġidità tal-muskoli u kontrazzjonijiet tal-muskoli) ikkawżati minn mediċini oħra.
English: While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Corbilta strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg.
Maltese: Filwaqt li l-esperjenza b'doża totali ta' kuljum ta' aktar minn 200 mg carbidopa hija limitata, id-doża massima ta' entacapone rrakkomandata kuljum hija ta' 2,000 mg u għalhekk id-doża massima hija ta' 10 pilloli kuljum għall-qawwiet ta' Corbilta ta' 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg u 150 mg/37.5 mg/200 mg.
English: Corbilta is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Maltese: Corbilta huwa ndikat għall-kura ta' pazjenti adulti bil-marda ta' Parkinson u b'oxxillazzjonijiet motorji tat-tmiem tad-doża li mhumiex stabbilizzati fuq kura b'levodopa/inibitur ta' dopa decarboxylase (DDC).
English: Serious events of gastrointestinal haemorrhage (uncommon) and angioedema (rare) have been identified from the clinical trials with Corbilta or entacapone combined with levodopa/DDC inhibitor.
Maltese: Avvenimenti serji ta' emorraġija gastro-intestinali (mhux komuni) u anġjoedima (rari) kienu identifikati mill-provi kliniċi b'Corbilta jew entacapone flimkien ma' levodopa/inibitur ta' DDC.
English: Corbilta contains sucrose (1.89 mg/tablet).
Maltese: Corbilta fih sucrose (1.89 mg/pillola).
English: The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Corbilta or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the postmarketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor.
Maltese: Ir-reazzjonijiet avversi li ġejjin, elenkati f'Tabella 1, ġew akkumulati kemm minn data miġbura flimkien ta' ħdax-il prova klinika, double-blind li kienu jikkonsistu minn 3230 pazjent (1810 ikkurati b'Corbilta jew entacapone flimkien ma' levodopa/inibitur ta' DDC, u 1420 ikkurati b'plaċebo flimkien ma' levodopa/inibitur ta' DDC jew cabergoline flimkien ma' levodopa/inibitur ta' DDC), kif ukoll mid-data ta' wara t-tqegħid fis-suq wara l-introduzzjoni ta' entacapone fis-suq għall-użu flimkien ta' entacapone u levodopa/inibitur ta' DDC.
English: According to this daily carbidopa dose, the maximum recommended daily dose of Corbilta175 mg/43.75 mg/200 mg is 8 tablets per day and Corbilta 200 mg/50 mg/200 mg dose is 7 tablets per day.
Maltese: Skont din id-doża ta' kuljum ta' carbidopa, id-doża massima rrakkomandata kuljum ta' Corbilta 175 mg/43.75 mg/200 mg hija 8 pilloli kuljum u ta' Corbilta 200 mg/50 mg/200 mg hija 7 pilloli kuljum.
English: Corbilta 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Maltese: Pilloli Corbilta 75 mg/18.75 mg/200 mg huma disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130, jew 175 pillola).
English: Discontinuation of Corbilta therapy: If Corbilta treatment (levodopa/carbidopa/entacapone) is discontinued and the patient is transferred to levodopa/DDC inhibitor therapy without entacapone, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
Maltese: Jekk kura b'Corbilta (levodopa/carbidopa/entacapone) titwaqqaf u l-pazjent jiġi trasferit għal terapija b'levodopa/inibitur ta' DDC mingħajr entacapone, huwa neċessarju li d-dożaġġ ta' kull kura oħra kontra l-marda ta' Parkinson jiġi aġġustat, speċjalment levodopa, sabiex jintlaħaq livell ta' kontroll suffiċjenti tas-sintomi tal-marda ta' Parkinson.
English: Do not take Corbilta if you are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
Maltese: Tiħux Corbilta jekk qed tieħu ċertu mediċini biex tikkura d-depressjoni (taħlita ta' inibituri selettivi ta' MAO-A u MAO-B, jew inibituri mhux selettivi ta' MAO).
English: Corbilta 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Maltese: Corbilta 75 mg/18.75 mg/200 mg: pilloli ovali, ta' lewn aħmar fil-kannella ċar, immarkati b'‘LCE 75' fuq naħa waħda.
English: Corbilta 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175).
Maltese: Corbilta 200 mg/50 mg/200 mg huwa disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130, jew 175 pillola).
English: Corbilta contains sucrose (2.3 mg/tablet).
Maltese: Corbilta fih sucrose (2.3 mg/pillola).
English: Management of acute overdose with Corbilta therapy is similar to acute overdose with levodopa.
Maltese: L-immaniġġjar ta' doża eċċessiva akuta b'terapija ta' Corbilta hija simili għal doża eċċessiva b'levodopa.
English: - Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Corbilta.
Maltese: - Hija rrakkomandata evalwazzjoni perjodika tal-funzjoni epatika, emopoetika, kardjovaskulari u renali waqt terapija mtawwla b'Corbilta.
English: Corbilta 125 mg/31.25 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 125' on one side.
Maltese: Corbilta 125 mg/31.25 mg/200 mg: pilloli ovali, ta' lewn aħmar fil-kannella ċar, immarkati b'‘LCE 125' fuq naħa waħda.
English: Corbilta 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Maltese: Pilloli Corbilta 125 mg/31.25 mg/200 mg huma disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130 jew 175 pillola).
English: Corbilta may increase the effects and side effects of certain medicines.
Maltese: Corbilta jista' jżid l-effetti u l-effetti sekondarji ta' xi mediċini.
English: - Each Corbilta 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Corbilta 100 mg/25 mg/200 mg fiha 100 mg ta' levodopa, 25 mg ta'carbidopa u 200 mg ta' entacapone.
English: No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Corbilta therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
Maltese: Ma ġew irrappurtati l-ebda studji partikolari dwar il-farmakokinetika ta' levodopa u carbidopa f'pazjenti b'insuffiċjenza renali, għalhekk terapija b'Corbilta għandha tingħata b'kawtela lill-pazjenti b'insuffiċjenza renali severa inkluż dawk li qed jirċievu terapija b'dijalisi (ara sezzjoni 5.2).
English: - Each Corbilta 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Corbilta 125 mg/31.25 mg/200 mg fiha 125 mg ta' levodopa, 31.25 mg ta' carbidopa u 200 mg ta' entacapone.
English: Serious hepatitis with mainly cholestatic features, rhabdomyolysis and neuroleptic malignant syndrome may occur with Corbilta although no cases have been identified from the clinical trial data.
Maltese: B'Corbilta jistgħu jseħħu epatite serja l-aktar b'karatteristiċi kolestatiċi, rabdomijolisi u sindrome newrolettiku malinn għalkemm ma kienu identifikati l-ebda każijiet mid-data tal-prova klinika.
English: - Each Corbilta 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Corbilta 75 mg/18.75 mg/200 mg fiha 75 mg ta' levodopa, 18.75 mg ta' carbidopa u 200 mg ta' entacapone.
English: - Each Corbilta 150 mg/37.5 mg/200 mg tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Corbilta 150 mg/37.5 mg/200 mg fiha 150 mg ta' levodopa, 37.5 mg ta'carbidopa u 200 mg ta' entacapone.
English: - Each Corbilta 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Corbilta 175 mg/43.75 mg/200 mg fiha 175 mg ta' levodopa, 43.75 mg ta' carbidopa u 200 mg ta' entacapone.
English: Corbilta contains sucrose (1.9 mg/tablet).
Maltese: Corbilta fih sucrose (1.9 mg/pillola).
English: - Each Corbilta 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Corbilta 50 mg/12.5 mg/200 mg fiha 50 mg ta' levodopa, 12.5 mg ta'carbidopa u 200 mg ta' entacapone.