FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Levodopa/Carbidopa/Entacapone Orion 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), Levodopa/Carbidopa/Entacapone Orion jista' potenzjalment jinterferixxi ma' sustanzi attivi bħal S-warfarin li l-metaboliżmu tagħhom jiddependi minn din l-iso-enzima.
English: Biotransformation and elimination: Levodopa is extensively metabolised to various metabolites: decarboxylation by dopa decarboxylase (DDC) and O-methylation by catechol-O-methyltransferase (COMT) being the most important pathways.
Maltese: Levodopa huwa metabolizzat b'mod estensiv f'bosta metaboliti: l-aktar metodi importanti huma decarboxylation minn dopa decarboxylase (DDC) u O-methylation minn catechol-O-methyltransferase (COMT).
English: Parkinsonism aggravated (e.g. bradykinesia)*, tremor, on and off phenomenon, dystonia, mental impairment (e.g. memory impairment, dementia), somnolence, dizziness*, headache
Maltese: Il-marda ta' Parkinson aggravata (eż. bradikajneżja)*, rogħda, fenomenu ‘on-off', distonja, indeboliment mentali (eż. nuqqas ta' memorja, dimenzja), ngħas, sturdament*, uġigħ ta' ras
English: With inhibition of the decarboxylase by a DDC inhibitor, catechol-O-methyltransferase (COMT) becomes the major peripheral metabolic pathway catalyzing the conversion of levodopa to 3-Omethyldopa (3-OMD), a potentially harmful metabolite of levodopa.
Maltese: Bl-inibizzjoni ta' decarboxylase minn inibitur ta' DDC, catechol-O-methyltransferase (COMT) isir il-metodu ta' metabolizzazzjoni periferali maġġuri li jikkatalizza il-konversjoni ta' levodopa għal 3-O-methyldopa (3-OMD), metabolita ta' levodopa li jista' jkun ta' ħsara.
English: Label 10 tablets 30 tablets 100 tablets 130 tablets 175 tablets
Maltese: Tikketta 10 pilloli 30 pillola 100 pillola 130 pillola 175 pillola
English: Pack sizes of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg: 10, 30, 100, 130, 175 and 250 tablets.
Maltese: Daqsijiet tal-pakkett ta' 50/12.5/200 mg, 100/25/200 mg u 150/37.5/200 mg: 10, 30, 100, 130, 175 u 250 pillola.
English: Renal impairment: Renal impairment does not affect the pharmacokinetics of entacapone.
Maltese: Indeboliment renali ma jaffettwax il-farmakokinetika ta' entacapone.
English: The distribution volume of both levodopa (Vd 0.36-1.6 l/kg) and entacapone (Vdss 0.27 l/kg) is moderately small while no data for carbidopa are available.
Maltese: Il-volum ta' distribuzzjoni kemm ta' levodopa (Vd 0.36-1.6 l/kg) kif ukoll ta' entacapone (Vdss 0.27 l/kg) huwa moderatament żgħir waqt li m'hemmx data disponibbli dwar carbidopa.
English: Tablet core:
Maltese: Data in vitro:
English: - Coadministration of Levodopa/Carbidopa/Entacapone Orion with non-selective monoamine oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine, tranylcypromine).
Maltese: monoamine oxidase (MAO-A u MAO-B) (eż. phenelzine, tranylcypromine).
English: - The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421) and povidone (E1201).
Maltese: - Is-sustanzi l-oħra fil-qalba tal-pillola huma croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421) u povidone (E1201).
English: These include: - medicines used to treat depression such as moclobemide, amitriptyline, desipramine,
Maltese: Dawn jinkludu: - mediċini wżati għall-kura tad-depressjoni bħal moclobemide, amitriptyline, desipramine,
English: A significant number of Parkinson's disease patients have been treated with the combination of levodopa, carbidopa and entacapone with several active substances 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. catechol-structured compounds, paroxetine).
Maltese: Numru sinifikanti ta' pazjenti bil-marda ta' Parkinson ġew ikkurati bit-taħlita ta' levodopa, carbidopa u entacapone ma' bosta sustanzi attivi inkluż inibituri MAO-A, antidepressanti triċikliċi, inibituri tat-teħid mill-ġdid ta' noradrenaline bħal desipramine, maprotiline u venlafaxine u prodotti mediċinali li huma metabolizzati minn COMT (eż. prodotti li għandhom struttura ta' catechol, paroxetine).
English: In vitro data: Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Maltese: Entacapone jeħel mas-sit ta' twaħħil II tal-albumina umana fejn jeħlu wkoll bosta prodotti mediċinali oħrajn, inkluż diazepam u ibuprofen.
English: Common (may affect up to 1 in 10 people) - light-headedness or fainting due to low blood pressure, high blood pressure - worsening of Parkinson`s symptoms, dizziness, drowsiness - vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation - inability to sleep, hallucinations, confusion, abnormal dreams (including nightmares), tiredness - mental changes - including problems with memory, anxiety and depression (possibly with thoughts of suicide) - heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm - more frequent falling - shortness of breath - increased sweating, rashes - muscle cramps, swelling of legs - blurred vision - anaemia - decreased appetite, decreased weight - headache, joint pain - urinary tract infection
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - tħossok mifxul jew ikollok ħass ħażin minħabba pressjoni tad-demm baxxa, pressjoni għolja - sintomi tal-marda ta' Parkinson imorru għal agħar, sturdament, ngħas - rimettar, uġigħ u skomdu addominali, ħruq ta' stonku, ħalq xott, stitikezza - inabbiltà biex torqod, alluċinazzjonijiet, konfużjoni, ħolm mhux normali (inkluż inkubi), għeja - bidliet mentali - inkluż problemi bil-memorja, ansjetà u depressjoni (possibilment bi ħsibijiet ta' suwiċidju) - avvenimenti ta' mard tal-qalb jew tal-arterji (eż. uġigħ fis-sider), rata jew ritmu tal-qalb irregolari - waqgħat aktar frekwenti - qtugħ ta' nifs - żjieda fl-għaraq, raxx - bugħawwieġ fil-muskoli, nefħa fis-saqajn - tara mċajpar - anemija - tnaqqis fl-aptit, tnaqqis fil-piż - uġigħ ta' ras, uġigħ fil-ġogi - infezzjoni fl-apparat tal-awrina
English: - Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson's disease.
Maltese: - Rabdomijolisi sekondarja għal diskinesja severa jew sindrome newrolettiku malinn (NMS) kienet osservata b'mod rari f'pazjenti bil-marda ta' Parkinson.
English: c.
Maltese: A.
English: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets
Maltese: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg pilloli miksija b'rita Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg pilloli miksija b'rita Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg pilloli miksija b'rita Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg pilloli miksija b'rita Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg pilloli miksija b'rita Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg pilloli miksija b'rita Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg pilloli miksija b'rita
English: Film-coating of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg: Glycerol (85 per cent) (E422)
Maltese: Kisja b'rita ta' 50/12.5/200 mg, 100/25/200 mg u 150/37.5/200 mg: Glycerol (85 fil-mija) (E422)
English: According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Maltese: Skont studji in vitro, mhux mistenni sostituzzjoni sinifikanti f'konċentrazzjonijiet terapewtiċi tal-prodotti mediċinali.
English: The daily dose should be preferably optimised using one of the seven available tablet strengths (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, 150 mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg levodopa/carbidopa/entacapone).
Maltese: Id-doża ta' kuljum għandha preferibilment tiġi ottimizzata bl-użu ta' waħda mis-seba' qawwiet ta' pilloli disponibbli (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, 150 mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg jew 200 mg/50 mg/200 mg levodopa/carbidopa/entacapone).
English: Serious events of gastrointestinal haemorrhage (uncommon) and angioedema (rare) have been identified from the clinical trials with Levodopa/Carbidopa/Entacapone Orion 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'Levodopa/Carbidopa/Entacapone Orion jew entacapone flimkien ma' levodopa/inibitur ta' DDC.
English: A syndrome resembling the neuroleptic malignant syndrome including muscular rigidity, elevated body temperature, mental changes and increased serum creatine phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents.
Maltese: Sindrome li jixbaħ is-sindrome newrolettiku malinn inkluż riġidità fil-muskoli, temperatura tal-ġisem elevata, bidliet mentali u żjieda tal-creatine phosphokinase fis-serum kien irrappurtat mal-waqfien f'daqqa ta' sustanzi kontra l-marda ta' Parkinson.
English: The most frequently reported adverse reactions with Levodopa/Carbidopa/Entacapone Orion 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'Levodopa/Carbidopa/Entacapone Orion 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, muskoluskeletriku 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: The acute symptoms and signs in these cases of overdose included agitation, confusional state, coma, bradycardia, ventricular tachycardia, Cheyne-Stokes respiration, discolourations of skin, tongue and conjunctiva, and chromaturia.
Maltese: Is-sintomi u s-sinjali akuti ta' dawn il-każijiet ta' doża eċċessiva kienu jinkludu aġitazzjoni, stat konfuż, koma, bradikardija, takikardija ventrikulari, respirazzjoni Cheyne-Stokes, bidla fil-kulur tal-ġilda, ilsien u konġuntiva, u kromaturja.
English: The main metabolic pathway is glucuronidation of entacapone and its active metabolite, the cis-isomer, which accounts for about 5% of plasma total amount.
Maltese: Ir-rotta metabolika prinċipali hija l-glucuronidation ta' entacapone u tal-metabolita attiv tiegħu, cis-isomer, li jikkonstitwixxi madwar 5% tal-kwantità totali fil-plażma.
English: Levodopa/Carbidopa/Entacapone Orion 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: Levodopa/Carbidopa/Entacapone Orion 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: Pack sizes of 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg and 200/50/200 mg: 10, 30, 100, 130 and 175 tablets.
Maltese: Daqsijiet tal-pakkett ta' 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg u 200/50/200 mg: 10, 30, 100, 130 u 175 pillola.
English: Film-coating of 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg and 200/50/200 mg: Glycerol (85 per cent) (E422)
Maltese: Kisja b'rita ta' 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg u 200/50/200 mg: Glycerol (85 fil-mija) (E422)
English: Suicidal behaviour, Dopamine dysregulation syndrome
Maltese: Mġiba ta' suwiċidju, sindrome ta' indeboliment fir-regolazzjoni ta' dopamine
English: Interactions between entacapone and imipramine and between entacapone and moclobemide have been investigated in single dose studies in healthy volunteers.
Maltese: Interazzjonijiet bejn entacapone u imipramine u bejn entacapone u moclobemide ġew investigati fi studji b'doża waħda f'voluntiera f'saħħithom.
English: Levodopa is bound to plasma protein only to a minor extent of about 10-30% and carbidopa is bound approximately 36%, while entacapone is extensively bound to plasma proteins (about 98%) -mainly to serum albumin.
Maltese: Levodopa jeħel mal-proteini fil-plażma b'mod minimu biss, ta' madwar 10-30% u carbidopa jeħel b'madwar 36%, filwaqt li entacapone jeħel b'mod estensiv mal-proteini fil-plażma (madwar 98%), primarjament mal-albumina fis-serum.
English: Total clearance for levodopa is in the range of 0.55-1.38 l/kg/h and for entacapone is in the range of 0.70 l/kg/h.
Maltese: It-tneħħija totali ta' levodopa hija fil-firxa ta' 0.55-1.38 l/kg/h u ta' entacapone hija fil-firxa ta' 0.70 l/kg/h.
English: Orion Pharma AB Tel: +46 8 623 6440
Maltese: Tel: +46 8 623 6440
English: Dyskinesia*
Maltese: Diskajneżja*
English: - Levodopa/Carbidopa/Entacapone Orion may induce orthostatic hypotension.
Maltese: - Levodopa/Carbidopa/Entacapone Orion jista' jinduċi pressjoni ortostatika baxxa.
English: Levodopa/Carbidopa/Entacapone Orion comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Maltese: Levodopa/Carbidopa/Entacapone Orion huwa disponibbli f'sitt daqsijiet ta' pakketti differenti (10, 30, 100, 130, 175 jew 250 pillola).
English: Contains sucrose.
Maltese: Fih sucrose.
English: According to the current understanding, the symptoms of Parkinson's disease are related to depletion of dopamine in the corpus striatum.
Maltese: Skont fehim kurrenti, is-sintomi tal-marda ta' Parkinson huma relatati ma' tnaqqis ta' dopamine fil-corpus striatum.
English: MAO-B inhibitors, or non-selective MAO-inhibitors) - have ever had neuroleptic malignant syndrome (NMS - this is a rare reaction to medicines used to treat severe mental disorders) - have ever had non-traumatic rhabdomyolysis (a rare muscle disorder) - have a severe liver disease.
Maltese: MAO-B, jew inibituri mhux selettivi ta' MAO) - qatt kellek sindrome newrolettiku malinn (NMS - dan huwa reazzjoni rari għall-mediċini użati fil-kura ta' disturbi mentali) - qatt kellek rabdomijolisi mhux trawmatika (disturb muskolari rari) - għandek mard sever tal-fwied.
English: The elimination-half life is (t1/2) is 0.6-1.3 hours for levodopa, 2-3 hours for carbidopa and 0.4-0.7 hours for entacapone, each given separately.
Maltese: Meta kull wieħed jingħata b'mod separat, il-half-life tal-eliminazzjoni (t1/2) hija 0.6-1.3 sigħat għal levodopa, 2-3 sigħat għal carbidopa u 0.4-0.7 sigħat għal entacapone.
English: There are no significant differences in the AUC of carbidopa or entacapone between younger (45-64 years) and elderly (65-75 years).
Maltese: Ma hemm l-ebda differenzi sinifikanti fl-AUC ta' carbidopa jew entacapone bejn individwi iżgħar (45-64 sena) u dawk anzjani (65-75 sena).
English: Dopamine dysregulation syndrome (DDS) is described as a compulsive pattern of dopaminergic misuse above doses adequate to control motor symptoms.
Maltese: Is-sindrome ta' indeboliment fir-regolazzjoni ta' dopamine (DDS, Dopamine Dysregulation Syndrome) huwa deskritt bħala mod kompulsiv ta' użu ħażin ta' sustanzi dopaminerġiċi aktar middożi li huma biżżejjed biex jikkontrollaw is-sintomi motorji.
English: The post-marketing data includes isolated cases of overdose in which the reported highest daily doses of levodopa and entacapone have been at least 10,000 mg and 40,000 mg, respectively.
Maltese: Data wara t-tqegħid fis-suq tinkludi każijiet iżolati ta' doża eċċessiva fejn l-ogħla dożi rrappurtati kuljum ta' levodopa u entacapone kienu mill-inqas 10,000 mg u 40,000 mg, rispettivament.
English: Hepatic impairment: The metabolism of entacapone is slowed in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B) leading to an increased plasma concentration of entacapone both in the absorption and elimination phases (see sections 4.2 and 4.3).
Maltese: Il-metaboliżmu ta' entacapone huwa aktar bil-mod f'pazjenti b'indeboliment epatiku ħafif għal moderata (Child-Pugh Klassi A u B) li jwassal għal żjieda fil-konċentrazzjoni ta' entacapone fil-plażma kemm fil-fażi ta' assorbiment kif ukoll f'dik ta' eliminazzjoni (ara sezzjonijiet 4.2 u 4.3).
English: This corresponded to an 8.3% increase in the proportion of daily ON time.
Maltese: Dan kien jikkorrispondi għal żjieda ta' 8.3% fil-proporzjon tal-perjodu ON ta' kuljum.
English: Entacapone slows the clearance of levodopa from the bloodstream resulting in an increased area under the curve (AUC) in the pharmacokinetic profile of levodopa.
Maltese: Entacapone inaqqas ir-rata tat-tneħħija ta' levodopa mid-demm u jwassal għal żjieda fl-erja taħt il-kurva (AUC - area under the curve) fil-profil farmakokinetiku ta' levodopa.
English: Antidepressants: Rarely, reactions including hypertension and dyskinesia have been reported with the concomitant use of tricyclic antidepressants and levodopa/carbidopa.
Maltese: Rarament, reazzjonijiet inkluż pressjoni għolja u diskinesja ġew irrappurtati bl-użu fl-istess ħin ta' antidepressanti triċikliċi u levodopa/carbidopa.
English: maprotiline, venlafaxine and paroxetine - rimiterole and isoprenaline, used to treat respiratory diseases - adrenaline, used for severe allergic reactions - noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure - alpha-methyldopa, used to treat high blood pressure - apomorphine, which is used to treat Parkinson's disease.
Maltese: maprotiline, venlafaxine u paroxetine - rimiterole u isoprenaline, użati għall-kura ta' mard respiratorju - adrenaline, użat għall-reazzjonijiet allerġiċi severi - noradrenaline, dopamine u dobutamine, użati għall-kura ta' mard tal-qalb u pressjoni tad-demm baxxa - alpha-methyldopa, użat għall-kura ta' pressjoni tad-demm għolja - apomorphine, li jintuża għall-kura tal-marda ta' Parkinson.
English: Other active substances: Dopamine receptor antagonists (e.g. some antipsychotics and antiemetics), phenytoin and papaverine may reduce the therapeutic effect of levodopa.
Maltese: Sustanzi attivi oħra: Antagonisti tar-riċetturi ta' dopamine (eż. ċertu antipsikotiċi u anti-emetiċi), phenytoin u papaverine jistgħu jnaqqsu l-effett terapewtiku ta' levodopa.
English: Other adverse reactions with an asterisk in Table 1, section 4.8b are marked based on either their more frequent occurring (by the frequency difference of at least 1%) in the clinical trial data with entacapone than levodopa/DDCI alone or the individual case safety reports received after the introduction of entacapone into the market.
Maltese: Reazzjonijiet avversi oħra immarkati b'asterisk f'Tabella 1, sezzjoni 4.8b huma mmarkati peress li seħħu b'mod aktar frekwenti (b'differenza fil-frekwenza ta' mill-inqas 1%) fid-data tal-prova klinika b'entacapone milli b'levodopa/DDCI waħdu jew minħabba rapporti ta' sigurtà tal-każ individwali li waslu wara l-introduzzjoni ta' entacapone fis-suq.
English: Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with carbidopa/levodopa.
Maltese: Sindrome ta' Indeboliment fir-Regolazzjoni ta' Dopamine (DDS - Dopamine Dysregulation Syndrome) huwa disturb ta' dipendenza osservat f'xi pazjenti ttrattati b'carbidopa/ levodopa.
English: Rhabdomyolysis*
Maltese: Mhux magħruf: Rabdomijolisi*
English: 75 mg/18.75 mg/200 mg Each tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
Maltese: 75 mg/18.75 mg/200 mg Kull pillola fiha 75 mg ta' levodopa, 18.75 mg ta' carbidopa u 200 mg ta' entacapone.
English: - Patients should be regularly monitored for the development of impulse control disorders.
Maltese: - Il-pazjenti għandhom ikunu mmonitorjati regolarment għal żvilupp ta' disturbi tal-kontroll tal-impulsi.
English: - Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Levodopa/Carbidopa/Entacapone Orion.
Maltese: - Hija rrakkomandata evalwazzjoni perjodika tal-funzjoni epatika, emopoetika, kardjovaskulari u renali waqt terapija mtawwla b'Levodopa/Carbidopa/Entacapone Orion.
English: Discontinuation of Levodopa/Carbidopa/Entacapone Orion therapy: If Levodopa/Carbidopa/Entacapone Orion 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'Levodopa/Carbidopa/Entacapone Orion (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: Carbidopa and benserazide are peripheral DDC inhibitors which reduce the peripheral metabolism of levodopa to dopamine, and thus, more levodopa is available to the brain.
Maltese: Carbidopa u benserazide huma inibituri ta' DDC periferali li jnaqqsu il-metaboliżmu periferali ta' levodopa għal dopamine, u b'hekk, aktar levodopa jkun disponibbli għall-moħħ.
English: **The incidence rates of myocardial infarction and other ischemic heart disease events (0.43% and 1.54%, respectively) are derived from an analysis of 13 double-blind studies involving 2082 patients with end-of-dose motor fluctuations receiving entacapone.
Maltese: 43% u 1.54%, rispettivament) huma derivati minn analiżi ta' 13-il studju double-blind li kienu jinvolvu 2082 pazjent b'varjazzjonijiet motorji tal-aħħar tad-doża li kienu qed jirċievu entacapone.
English: When given separately without the two other active substances, the bioavailability for levodopa is 15-33%, for carbidopa 40-70% and for entacapone 35% after a 200 mg oral dose.
Maltese: Meta jingħata separatament mingħajr iż-żewġ sustanzi attiv l-oħra, il-bijodisponibiltà għal levodopa hija 15-33%, għal carbidopa 40-70% u għal entacapone 35% wara doża orali ta' 200 mg.
English: Do not take Levodopa/Carbidopa/Entacapone Orion 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 Levodopa/Carbidopa/Entacapone Orion 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: - Entacapone in association with levodopa has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson's disease and caution should therefore be exercised when driving or operating machines (see section 4.7).
Maltese: - Entacapone flimkien ma' levodopa kien assoċjat ma' ngħas u episodji ta' attakki ta' ngħas f'daqqa f'pazjenti bil-marda ta' Parkinson u għalhekk għandu jkun hemm kawtela waqt is-sewqan jew tħaddim ta' magni (ara sezzjoni 4.7).
English: 175 mg/43.75 mg/200 mg Each tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Maltese: 175 mg/43.75 mg/200 mg Kull pillola fiha 175 mg ta' levodopa, 43.75 mg ta' carbidopa u 200 mg ta' entacapone.