FrancophonIA/ELRC3.0 huggingface dataset:
English: Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Levodopa/Carbidopa/Entacapone Orion (see section 4.4).
Maltese: Jista' jkun hemm logħob tal-ażżard patoloġiku, żieda fil-libido, ipersesswalità, infiq jew xiri kompulsiv, ikel bl-addoċċ u b'mod kompulsiv f'pazjenti mogħtija agonisti ta' dopamine u/jew trattamenti dopaminerġiċi oħrajn li fihom levodopa inkluż Levodopa/Carbidopa/Entacapone Orion (ara sezzjoni 4.4).
English: - Coadministration with a selective MAO-A inhibitor and a selective MAO-B inhibitor (see section 4.5).
Maltese: - Għoti flimkien ma' inibitur selettiv ta' MAO-A u inibitur selettiv ta' MAO-B (ara sezzjoni 4.5).
English: Renal and urinary disorders Very common:
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Komuni ħafna:
English: If required, appropriate anti-arrhythmic therapy should be given.
Maltese: Jekk hemm bżonn, għandha tingħata terapija anti-arritmika xierqa.
English: levodopa/carbidopa/entacapone orion 75/18.75/200 mg [carton only]
Maltese: levodopa/carbidopa/entacapone orion 75/18.75/200 mg [kartuna biss]
English: 100 mg/25 mg/200 mg Each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Maltese: 100 mg/25 mg/200 mg Kull pillola fiha 100 mg ta' levodopa, 25 mg ta' carbidopa u 200 mg ta' entacapone.
English: 50 mg/12.5 mg/200 mg Each tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
Maltese: 50 mg/12.5 mg/200 mg Kull pillola fiha 50 mg ta' levodopa, 12.5 mg ta' carbidopa u 200 mg ta' entacapone.
English: Other antiparkinsonian medicinal products: To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Levodopa/Carbidopa/Entacapone Orion therapy.
Maltese: Prodotti mediċinali kontra l-marda ta' Parkinson oħra: S'issa ma kienx hemm indikazzjoni ta' interazzjonijiet li ma jippermettux l-użu flimkien ta' prodotti mediċinali standard kontra l-marda ta' Parkinson ma' terapija b'Levodopa/Carbidopa/Entacapone Orion.
English: 125 mg/31.25 mg/200 mg Each tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Maltese: 125 mg/31.25 mg/200 mg Kull pillola fiha 125 mg ta' levodopa, 31.25 mg ta' carbidopa u 200 mg ta' entacapone.
English: Always leave at least an hour between Levodopa/Carbidopa/Entacapone Orion tablets, to avoid possible side effects.
Maltese: Dejjem ħalli mill-inqas siegħa bejn pilloli Levodopa/Carbidopa/Entacapone Orion, sabiex tevita effetti sekondarji possibbli.
English: 150 mg/37.5 mg/200 mg tablets, do not take more than 10 tablets each day.
Maltese: 150 mg/37.5 mg/200 mg, tiħux aktar minn 10 pilloli kuljum.
English: 150 mg/37.5 mg/200 mg Each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Maltese: 150 mg/37.5 mg/200 mg Kull pillola fiha 150 mg ta' levodopa, 37.5 mg ta' carbidopa u 200 mg ta' entacapone.
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 Levodopa/Carbidopa/Entacapone Orion 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' Levodopa/Carbidopa/Entacapone Orion 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
English: - If you are taking Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg,
Maltese: - Jekk qed tieħu pilloli ta' Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg,
English: Detailed information on this medicine is available on the European Medicine's Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: Patients receiving less than 70-100 mg carbidopa a day are more likely to experience nausea and vomiting.
Maltese: Pazjenti li qed jirċievu inqas minn 70-100 mg carbidopa kuljum huma aktar probabbli li jkollhom tqallih u rimettar.
English: - The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow iron oxide (E172).
Maltese: - Is-sustanzi fil-kisja b'rita huma glycerol (85 fil-mija) (E422), hypromellose, magnesium stearate, polysorbate 80, iron oxide aħmar (E172), sucrose, titanium dioxide (E171), u iron oxide isfar (E172).
English: levodopa/carbidopa/entacapone orion 175/43.75/200 mg [carton only]
Maltese: levodopa/carbidopa/entacapone orion 175/43.75/200 mg [kartuna biss]
English: Correspondingly, the decrease in daily OFF time was 24% in the entacapone group and 0% in the placebo group.
Maltese: B'hekk, it-tnaqqis tal-perjodu OFF ta' kuljum kien ta' 24% fil-grupp ta' entacapone u 0% fil-grupp tal-plaċebo.
English: Rash*, hyperhidrosis
Maltese: Raxx*, għaraq eċċessiv
English: Ten tablets of Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
Maltese: Għaxar pilloli ta' Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg huma ekwivalenti għal 375 mg ta' carbidopa kuljum.
English: levodopa/carbidopa/entacapone orion 125/31.25/200 mg [carton only]
Maltese: levodopa/carbidopa/entacapone orion 125/31.25/200 mg [kartuna biss]
English: Levodopa, carbidopa and entacapone together may cause dizziness and symptomatic orthostatism.
Maltese: Levodopa, carbidopa u entacapone flimkien jistgħu jikkawżaw sturdament u ortostatiżmu sintomatiku.
English: How to transfer patients taking levodopa/DDC inhibitor (carbidopa or benserazide) preparations and entacapone tablets to Levodopa/Carbidopa/Entacapone Orion a. Patients who are currently treated with entacapone and with standard release levodopa/carbidopa in doses equal to Levodopa/Carbidopa/Entacapone Orion tablet strengths can be directly transferred to corresponding Levodopa/Carbidopa/Entacapone Orion tablets.
Maltese: Kif taqleb pazjenti li qed jieħdu preparazzjonijiet ta' levodopa/inibitur ta' DDC (carbidopa jew benserazide) u pilloli entacapone għal Levodopa/Carbidopa/Entacapone Orion a.
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 Levodopa/Carbidopa/Entacapone Orion 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 post-marketing 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'Levodopa/Carbidopa/Entacapone Orion 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: - Each Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg fiha 100 mg ta' levodopa, 25 mg ta'carbidopa u 200 mg ta' entacapone.
English: Levodopa/Carbidopa/Entacapone Orion 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: Levodopa/Carbidopa/Entacapone Orion 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: 200 mg/50 mg/200 mg Each tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Maltese: 200 mg/50 mg/200 mg Kull pillola fiha 200 mg ta' levodopa, 50 mg ta' carbidopa u 200 mg ta' entacapone.
English: Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg: brownish or greyish red, elongatedellipse shaped, unscored film-coated tablets marked with ‘LCE 150' on one side.
Maltese: Levodopa/Carbidopa/Entacapone Orion 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: - The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).
Maltese: - Is-sustanzi fil-kisja b'rita huma glycerol (85 fil-mija) (E422), hypromellose, magnesium stearate, polysorbate 80, iron oxide aħmar (E172), sucrose u titanium dioxide (E171).
English: Cumulatively, dopamine dysregulation syndrome has been included in 10 reports.
Maltese: B'kollox, is-sindrome ta' indeboliment fir-regolazzjoni ta' dopamine ġie inkluż f'10 rapporti.
English: Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Maltese: Pilloli Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg huma disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130, jew 175 pillola).
English: Levodopa/Carbidopa/Entacapone Orion and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
Maltese: Għalhekk, Levodopa/Carbidopa/Entacapone Orion u preparazzjonijiet li fihom il-ħadid għandhom jittieħdu tal-inqas 2-3 sigħat bogħod minn xulxin (ara sezzjoni 4.8).
English: Pyridoxine, however, is not effective in reversing the actions of Levodopa/Carbidopa/Entacapone Orion.
Maltese: Madankollu, Pyridoxine mhux effettiv biex jaqleb l-azzjonijiet ta' Levodopa/Carbidopa/Entacapone Orion.
English: - Severe hepatic impairment.
Maltese: Indeboliment epatiku:
English: levodopa/carbidopa/entacapone orion 50/12.5/200 mg [carton only]
Maltese: levodopa/carbidopa/entacapone orion 50/12.5/200 mg [kartuna biss]
English: These include: - dopamine antagonists used to treat mental disorders, nausea and vomiting - phenytoin, used to prevent convulsions - papaverine used to relax the muscles.
Maltese: - antagonisti ta' dopamine użati għall-kura ta' disturbi mentali, tqalligħ u rimettar - phenytoin, użat biex jipprevjeni konvulżjonijiet - papaverine, użat biex jirrilassa l-muskoli.
English: levodopa/carbidopa/entacapone orion 150/37.5/200 mg [carton only]
Maltese: levodopa/carbidopa/entacapone orion 150/37.5/200 mg [kartuna biss]
English: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Maltese: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg huwa disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130, jew 175 pillola).
English: - Each Levodopa/Carbidopa/Entacapone Orion 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 Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg fiha 75 mg ta' levodopa, 18.75 mg ta' carbidopa u 200 mg ta' entacapone.
English: - Each Levodopa/Carbidopa/Entacapone Orion 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 Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg fiha 125 mg ta' levodopa, 31.25 mg ta' carbidopa u 200 mg ta' entacapone.
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.89 mg/tablet).
Maltese: Levodopa/Carbidopa/Entacapone Orion fih sucrose (1.89 mg/pillola).
English: - Each Levodopa/Carbidopa/Entacapone Orion 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 Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg fiha 175 mg ta' levodopa, 43.75 mg ta' carbidopa u 200 mg ta' entacapone.
English: Management of acute overdose with Levodopa/Carbidopa/Entacapone Orion therapy is similar to acute overdose with levodopa.
Maltese: L-immaniġġjar ta' doża eċċessiva akuta b'terapija ta' Levodopa/Carbidopa/Entacapone Orion hija simili għal doża eċċessiva b'levodopa.
English: Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
Maltese: Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg: pilloli ovali, ta' lewn aħmar fil-kannella ċar, mingħajr sinjal imnaqqax, immarkati b'‘LCE 175' fuq naħa waħda.
English: However, no interaction with carbidopa has been observed with the recommended treatment schedule (200 mg of entacapone up to 10 times daily).
Maltese: Iżda, ma kienet osservata l-ebda interazzjoni ma' carbidopa bil-programm ta' kura rrakkomandata (200 mg ta' entacapone sa 10 darbiet kuljum).
English: Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg: light brownish red, oval filmcoated tablets marked with ‘LCE 125' on one side.
Maltese: Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg: pilloli ovali, ta' lewn aħmar fil-kannella ċar, immarkati b'‘LCE 125' fuq naħa waħda.
English: levodopa/carbidopa/entacapone orion 100/25/200 mg [carton only]
Maltese: levodopa/carbidopa/entacapone orion 100/25/200 mg [kartuna biss]
English: - Each Levodopa/Carbidopa/Entacapone Orion 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 Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg fiha 50 mg ta' levodopa, 12.5 mg ta'carbidopa u 200 mg ta' entacapone.
English: Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Maltese: Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg: pilloli ovali, ta' lewn aħmar fil-kannella ċar, immarkati b'‘LCE 75' fuq naħa waħda.
English: - Each Levodopa/Carbidopa/Entacapone Orion 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 Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg fiha 150 mg ta' levodopa, 37.5 mg ta'carbidopa u 200 mg ta' entacapone.
English: - Levodopa/Carbidopa/Entacapone Orion therapy should be administered cautiously to patients with ischemic heart disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal or endocrine disease, history of peptic ulcer disease or history of convulsions.
Maltese: - Terapija b'Levodopa/Carbidopa/Entacapone Orion għandha tingħata b'attenzjoni lill-pazjenti b'mard iskemiku tal-qalb, mard kardjovaskulari jew pulmonari sever, ażżma fil-bronki, mard renali jew endokrinali, passat ta' mard ta' ulċera peptika jew passat ta' konvulżjonijiet.
English: Other medicines and Levodopa/Carbidopa/Entacapone Orion
Maltese: Mediċini oħra u Levodopa/Carbidopa/Entacapone Orion
English: Very common (may affect more than 1 in 10 people) - uncontrolled movements (dyskinesias) - feeling sick (nausea) - harmless reddish-brown discolouration of urine - muscle pain - diarrhoea
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) - movimenti mhux ikkontrollati (diskajneżji) - tħossok imdardar (tqallih) - l-awrina tibdel il-kulur u ssir kannella fl-aħmar bla effett ħażin - uġigħ fil-muskoli - dijarea
English: levodopa/carbidopa/entacapone orion 200/50/200 mg [carton only]
Maltese: levodopa/carbidopa/entacapone orion 200/50/200 mg [kartuna biss]
English: Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Maltese: Pilloli Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg huma disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130 jew 175 pillola).
English: The SmPC section 4.4 and 4.8 are being updated to add Dopamine Dysregulation Syndrome (DDS) with a frequency “not known” and to add further explanation with regards to DDS to section 4.8 to increase awareness and understanding on the pathology and add a warning to section 4.4 to recommend relevant precautions.
Maltese: Is-sezzjoni SmPC 4.4 u 4.8 qed jiġu aġġornati biex jiżdied is-Sindromu ta 'Dopregolazzjoni Dysamina (DDS) bi frekwenza' mhux magħruf 'u biex tiżdied aktar spjegazzjoni fir-rigward tad-DDS fit-taqsima 4.8 biex tiżdied l-għarfien u l-fehim dwar il-patoloġija u tiżdied twissija mat-taqsima 4.4 biex tirrakkomanda prekawzjonijiet relevanti.
English: - Each Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola ta' Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg fiha 200 mg ta' levodopa, 50 mg ta'carbidopa u 200 mg ta' entacapone.
English: However, caution should be exercised when these medicinal products are used concomitantly with Levodopa/Carbidopa/Entacapone Orion (see sections 4.3 and 4.4).
Maltese: Iżda, għandha tintuża kawtela meta dawn il-prodotti mediċinali jintużaw flimkien ma' Levodopa/Carbidopa/Entacapone Orion (ara sezzjonijiet 4.3 u 4.4).
English: Excipient with known effect: Each tablet contains 2.3 mg of sucrose.
Maltese: Kull pillola fiha 2.3 mg ta' sucrose.
English: Excipient with known effect: Each tablet contains 1.9 mg of sucrose.
Maltese: Kull pillola fiha 1.9 mg ta' sucrose.
English: Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Maltese: Pilloli Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg huma disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130 jew 175 pillola).
English: Entacapone enhances the effects of levodopa.
Maltese: Entacapone issaħħaħ l-effetti ta' levodopa.
English: No pharmacodynamic interactions were observed.
Maltese: Ma ġew osservati l-ebda interazzjonijiet farmakodinamiċi.
English: For example, a patient taking one tablet of 50 mg/12.5 mg of levodopa/carbidopa with one tablet of entacapone 200 mg four times daily can take one 50 mg/12.5 mg/200 mg Levodopa/Carbidopa/Entacapone Orion tablet four times daily in place of their usual levodopa/carbidopa and entacapone doses.
Maltese: Per eżempju, pazjent li qed jieħu pillola waħda ta' 50 mg/12.5 mg ta' levodopa/carbidopa ma' pillola waħda ta' entacapone 200 mg erba' darbiet kuljum jista' jieħu pillola waħda ta' 50 mg/12.5 mg/200 mg Levodopa/Carbidopa/Entacapone Orion erba' darbiet kuljum flok id-dożi tas-soltu ta' levodopa/carbidopa u entacapone.
English: EU/1/11/706/034 10 film-coated tablets EU/1/11/706/035 30 film-coated tablets EU/1/11/706/036 100 film-coated tablets EU/1/11/706/037 130 film-coated tablets EU/1/11/706/038 175 film-coated tablets
Maltese: EU/1/11/706/034 10 pilloli miksija b'rita EU/1/11/706/035 30 pillola miksija b'rita EU/1/11/706/036 100 pillola miksija b'rita EU/1/11/706/037 130 pillola miksija b'rita EU/1/11/706/038 175 pillola miksija b'rita
English: Dyspnoea
Maltese: Pożoloġija
English: These can be symptoms of neuroleptic malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare severe muscle disorder).
Maltese: Dawn jistgħu jkunu sintomi tas-sindrome newrolettiku malinn (NMS, reazzjoni severa u rari għall-mediċini wżati għall-kura ta' disturbi tas-sistema nervuża ċentrali) jew rabdomijolisi (disturb tal-muskolu rari u sever).
English: 125 mg/31.25 mg/200 mg Light brownish red, oval film-coated tablets marked with ‘LCE 125' on one side.
Maltese: 125 mg/31.25 mg/200 mg Pilloli miskija b'rita, ta' lewn aħmar fil-kannella ċar, ovali, immarkati b'‘LCE 125' fuq naħa waħda.
English: Orthostatic hypotension, hypertension
Maltese: Pressjoni ortostatika baxxa, pressjoni għolja
English: b. When initiating Levodopa/Carbidopa/Entacapone Orion therapy for patients currently treated with entacapone and levodopa/carbidopa in doses not equal to Levodopa/Carbidopa/Entacapone Orion tablets (50 mg/12.5 mg/200 mg or 75 mg/18.75 mg/200 mg or 100 mg/25 mg/200 mg or 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg or 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg), Levodopa/Carbidopa/Entacapone Orion dosing should be carefully titrated for optimal clinical response.
Maltese: Meta tinbeda terapija b'Levodopa/Carbidopa/Entacapone Orion għall-pazjenti li bħalissa qed jiġu kkurati b'entacapone u b'levodopa/carbidopa f'dożi mhux ugwali għall-pilloli Levodopa/Carbidopa/Entacapone Orion (50 mg/12.5 mg/200 mg, jew 75 mg/18.75 mg/200 mg jew 100 mg/25 mg/200 mg jew 125 mg/31.25 mg/200 mg jew 150 mg/37.5 mg/200 mg jew 175 mg/43.75 mg/200 mg jew 200 mg/50 mg/200 mg), l-iddożar ta' Levodopa/Carbidopa/Entacapone Orion għandu jiġi ttitrat b'kawtela għal respons kliniku ottimali. Levodopa/Carbidopa/Entacapone Orion għandu jiġi aġġustat biex jikkorrispondi b'mod viċin kemm jista' jkun għad-doża totali ta' kuljum ta' levodopa li tkun qed tintuża f'dak il-ħin.
English: 75 mg/18.75 mg/200 mg Light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Maltese: 75 mg/18.75 mg/200 mg Pilloli miskija b'rita, ta' lewn aħmar fil-kannella ċar, ovali, immarkati b'‘LCE 75' fuq naħa waħda.
English: *Adverse reactions that are mainly attributable to entacapone or are more frequent (by the frequency difference of at least 1% in the clinical trial data) with entacapone than levodopa/DDC inhibitor alone.
Maltese: *Ir-reazzjonijiet avversi li huma fil-biċċa l-kbira attribwiti għal entacapone jew li huma aktar frekwenti (b'differenza fil-frekwenza ta' mill-anqas 1% fid-data tal-prova klinika) b'entacapone milli b'levodopa/inibitur ta' DDC waħdu.
English: - In clinical studies, dopaminergic adverse reactions, e.g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
Maltese: - Fi studji kliniċi, reazzjonijiet dopaminerġiċi avversi, eż. diskinesja, kienu aktar komuni f'pazjenti li rċevew entacapone u agonisti ta' dopamine (bħal bromocriptine), selegiline jew amantadine meta mqabbel ma' dawk li rċevew plaċebo ma' din it-taħlita.
English: The following side effects have also been reported: - hepatitis (inflammation of the liver) - itching
Maltese: Kienu rrapportati wkoll l-effetti sekondarji li ġejjin: - epatite (infjammazzjoni tal-fwied) - ħakk
English: Interactions between entacapone and selegiline have been investigated in repeated dose studies in Parkinson's disease patients treated with levodopa/DDC inhibitor and no interaction was observed.
Maltese: Interazzjonijiet bejn entacapone u selegiline ġew investigati fi studji b'dożi ripetuti f'pazjenti bil-marda ta' Parkinson ikkurati b'levodopa/inibitur ta' DDC u ma kienet osservata l-ebda interazzjoni.
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (2.3 mg/tablet).
Maltese: Levodopa/Carbidopa/Entacapone Orion fih sucrose (2.3 mg/pillola).
English: After taking one of them, wait at least 2 to 3 hours before taking the other.
Maltese: Wara li tieħu wieħed minnhom, stenna mill-inqas 2 sa 3 sigħat qabel ma tieħu l-ieħor.