FrancophonIA/ELRC3.0 huggingface dataset:
English: For a full list of all side effects reported with Ecoporc Shiga, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Ecoporc Shiga, ara l-fuljett ta' tagħrif.
English: Why has Ecoporc Shiga been approved?
Maltese: Għaliex ġie approvat Ecoporc Shiga?
English: How has Ecoporc Shiga been studied?
Maltese: Kif ġie studjat Ecoporc Shiga?
English: It is caused by a bacterial toxin (poison) known as Shiga toxin 2e (Stx2e) that is produced by certain strains of Escherichia coli.
Maltese: Dan id-dokument ma jistax jissostitwixxi diskussjoni wiċċ imb'wiċċ mal-veterinarju tiegħek.
English: 1 h 20 min
Maltese: siegħa u 20 min
English: • antidepressants including desipramine, maprotiline, venlafaxine, paroxetine;
Maltese: • antidepressanti inkluż desipramine, maprotiline, venlafaxine, paroxetine;
English: Polyvinyl alcohol, partly hydrolysed Talc
Maltese: Polyvinyl alcohol, parti hydrolysed Talc
English: Yellow iron oxide (E 172) Red iron oxide (E 172) Titanium dioxide (E 171)
Maltese: Iron oxide isfar (E 172) Iron oxide aħmar (E 172) Titanium Dioxide (E 171)
English: 30 tablets 60 tablets 100 tablets 175 tablets
Maltese: 30 pillola 60 pillola 100 pillola 175 pillola
English: Baseline Week 8-24 66.8±14.5
Maltese: Linja bażi Ġimgħa 8-24 66.8±14.5
English: CI95% 45 min, 1 h 56 min Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
Maltese: CI95% 45 min, siegħa u 56 min Studju II: Proporzjon ta' Ħin On kuljum (%) Entacapone (n=103) Plaċebo (n=102)
English: Study I: Daily On time (h) Entacapone (n=85) Placebo (n=86)
Maltese: Studju I: Ħin On kuljum (sigħat) Entacapone (n=85) Plaċebo (n=86)
English: Gastrointestinal disorders Very common:
Maltese: Disturbi gastrointestinali Komuni ħafna:
English: The INR values increased on average by 13% [CI90 6-19%].
Maltese: Il-valuri tal-INR żdiedu b'medja ta' 13% [CI90 6-19%].
English: PC: {number} SN: {number} < NN: {number} >
Maltese: {numru} NN: {numru}
English: Hepatic impairment See section 4.3.
Maltese: Indeboliment tal-fwied Ara sezzjoni 4.3.
English: General characteristics of the active substance
Maltese: Karatteristiċi ġenerali tas-sustanza attiva Assorbiment
English: Date of first authorisation: 18 August 2011 Date of latest renewal: 8 April 2016
Maltese: Data tal-aħħar tiġdid: 8 ta' April 2016
English: The (E)-isomer accounts for 95% of the AUC of entacapone.
Maltese: L-isomeru (E) jikkonstitwixxi 95% tal-AUC ta' entacapone.
English: Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19) (see section
Maltese: Entacapone wera ftit jew l-ebda inibizzjoni ta' tipi oħra ta' isoenzimi P450 (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A u CYP2C19) (ara sezzjoni 4.5).
English: What Entacapone Orion contains - The active substance is entacapone.
Maltese: X'fih Entacapone Orion - Is-sustanza attiva hi entacapone.
English: There are four different pack sizes (bottles containing 30, 60, 100 or 175 tablets).
Maltese: Hemm erba' daqsijiet differenti tal-pakkett (fliexken li fihom 30, 60, 100 jew 175 pillola).
English: • abdominal pain.
Maltese: • uġigħ addominali.
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jista' jaffettwa sa persuna waħda minn kull 1,000):
English: The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Entacapone Orion.
Maltese: Id-doża massima rrakkomandata hija ta' 10 pilloli kuljum, i.e. 2,000 mg ta' Entacapone Orion.
English: povidone and magnesium stearate.
Maltese: povidone u magnesium stearate.
English: However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11-26%].
Maltese: Madanakollu, fi studju dwar l-interazzjonijiet, li sar f'volontiera f'saħħithom, entacapone ma biddilx il-livelli fil-plażma ta' S-warfarin, waqt li l-AUC għal R-warfarin żdied b'medja ta' 18% [CI90 11-26%].
English: The (Z)-isomer and traces of other metabolites account for the remaining 5%.
Maltese: L-isomeru (Z) u traċċi ta' metaboliti oħra jikkonstitwixxu l-5% l-oħra.
English: - Phaeochromocytoma.
Maltese: - Fejokromoċitoma.
English: Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 4 µM).
Maltese: Dejta miġbura minn studji in vitro fejn ikunu ntużaw sustanzi mikrosomali ta' fwied uman, turi li entacapone jinibixxi ċ-ċitokromju P450 2C9 (IC50 4 µM).
English: Approximately 92 % of the dose is eliminated during ß-phase with a short elimination half-life of 30 minutes.
Maltese: Madwar 92% tad-doża tiġi eliminata matul ilfazi-ß b'half-life tal-eliminazzjoni ta' 30 minuta.
English: Weight decrease * Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli, peress li l-ebda stima valida ma tista' tinkiseb mill-provi kliniċi jew studji epidemjoloġiċi).
English: • nausea;
Maltese: • Aġitazzjoni;
English: Ischaemic heart disease events other than myocardial infarction (e.g. angina pectoris)
Maltese: Episodji ta' mard iskemiku tal-qalb apparti infart mijokardijaku (eż. angina pectoris)
English: Clinical interaction studies with diazepam and nonsteroidal anti-inflammatory medicinal products have not been carried out.
Maltese: Ma sarux studji kliniċi ta' interazzjoni ma' diazepam u prodotti mediċinali anti-infjammatorji mhux sterojdi.
English: • Rashes;
Maltese: • Raxx;
English: In doses of 1,400 to 2,000 mg per day, the following side effects are more common:
Maltese: Fil-każ ta' dożi ta' bejn 1,400 u 2,000 mg kuljum, l-effetti sekondarji li ġejjin huma aktar komuni:
English: Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations 5-10% more than from standard levodopa/carbidopa preparations.
Maltese: Entacapone iżid il-bijodisponibilità ta' levodopa minn preparazzjonijiet standard ta' levodopa/benserazide b'5-10% aktar minn preparazzjonijiet standard ta' levodopa/carbidopa.
English: 10-20% is excreted in urine.
Maltese: Madwar 10-20% titneħħa fl-awrina.
English: Due to its affinity to cytochrome P450 2C9 in vitro (see section 5.2), entacapone may potentially interfere with medicinal products with metabolism dependent on this isoenzyme, such as S-warfarin.
Maltese: Minħabba l-affinità tiegħu għaċ-ċitokromju P450 2C9 in vitro (ara sezzjoni 5.2), entacapone jista' potenzjalment jinterferixxi ma' prodotti mediċinali b'metaboliżmu dipendenti fuq din l-isoenzima, bħalma huwa S-warfarin.
English: [carton only]:
Maltese: [kartuna biss]
English: Entacapone Orion contains soya lecithin.
Maltese: Entacapone Orion fih soya lecithin.
English: Entacapone may aggravate levodopa-induced orthostatic hypotension.
Maltese: Entacapone jista' jaggrava l-ipotensjoni ortostatika kkawżata minn levodopa.
English: Entacapone Orion contains soya lecithin
Maltese: Entacapone Orion fih soya lecithin
English: entacapone orion 200 mg [carton only]
Maltese: entacapone orion 200 mg [kartuna biss]
English: Very rare (may affect up to 1 in 10,000 people):
Maltese: Rari ħafna (jista' jaffettwa sa persuna waħda minn kull 10,000):
English: Excipient with known effect Each film-coated tablet contains 0.53 mg soya lecithin.
Maltese: Eċċipjent b'effett magħruf Kull pillola miksija b'rita fiha 0.53 mg soya lecithin.
English: However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catechol structured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine,alpha-methyldopa, apomorphine, and paroxetine) is still limited.
Maltese: Madanakollu, l-esperjenza bl-użu kliniku ta' entacapone ma' diversi prodotti mediċinali, inklużi l-inibituri MAO-A, antidepressanti triċikliċi, inibituri li jinibixxu l-assorbiment mill-ġdid ta' noradrenaline bħal desipramine, maprotiline u venlafaxine u prodotti mediċinali li jiġu metabolizzati b'COMT (eż. sustanzi bl-istruttura ta' catechol: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamina, dobutamine, alpha-methyldopa, apomorphine u paroxetine), għadha limitata.
English: Parkinsonism aggravated, dizziness, dystonia, hyperkinesia
Maltese: Marda ta' Parkinson taggrava, sturdament, distonja, iperkineżja
English: Pharmacotherapeutic group: other dopaminergic agents, ATC code: N04BX02.
Maltese: Kategorija farmakoterapewtika: sustanzi dopaminerġiċi oħra, Kodiċi ATC:
English: See Section 2 Warnings and precautions.
Maltese: Ara sezzjoni 2 Twissijiet u prekawzjonijiet.
English: • Uncontrollable movements;
Maltese: • Movimenti mhux kontrollabbli;
English: Adverse drug reactions*
Maltese: Reazzjonijiet avversi tal-mediċina*
English: • Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias);
Maltese: • Moviment mhux kontrollabbli b'diffikultà fit-twettiq ta' movimenti volontarji (diskineżji);
English: Do not take Entacapone Orion
Maltese: Tiħux Entacapone Orion
English: • if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS).
Maltese: • jekk qatt kellek reazzjoni rari għall-mediċini antipsikotiċi msejħa sindrome newrolettiku malinn (NMS - neuroleptic malignant syndrome).
English: NMS, including rhabdomyolysis and hyperthermia, is characterised by motor symptoms (rigidity, myoclonus, tremor), mental status changes (e.g. agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase.
Maltese: NMS, inkluż rabdomijolisi u ipertermija, huwa kkaratterizzat b'sintomi ta' diffikultajiet fiċ-ċaqliq (riġidità, majoklonus, tregħid), bidliet fl-istat mentali (eż. aġitazzjoni, konfużjoni, koma), ipertermija, disfunzjoni awtonomika (takikardija, pressjoni tad-demm mhux stabbli) u żieda fil-livell ta' creatinine phosphokinase fis-serum.
English: Thus, entacapone should be administered cautiously to patients being treated with medicinal products metabolised by catechol-Omethyl transferase (COMT), e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
Maltese: Għalhekk entacapone għandu jingħata b'kawtela lil dawk il-pazjenti li jkunu qed jiġu kkurati bi prodotti mediċinali li jiġu metabolizzati permezz ta' catechol-O-methyl transferase (COMT), eż. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa u apomorphine (ara wkoll sezzjoni 4.5).
English: 2D barcode carrying the unique identifier included [carton only]
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: • hallucinations (seeing/hearing/feeling/smelling things that are not really there), sleeplessness,
Maltese: • alluċinazzjonijiet (tara/tisma'/tħoss/ixxomm affarijiet li mhux vera qegħdin hemm), nuqqas ta'
English: - The other ingredients in the tablet core are microcrystalline cellulose, croscarmellose sodium,
Maltese: - Is-sustanzi l-oħra fil-qalba tal-pillola huma microcrystalline cellulose, croscarmellose sodium,
English: Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Maltese: Entacapone jintrabat mas-sit II tal-għaqda tal-albumina umana, ma' fejn jeħlu wkoll diversi prodotti mediċinali oħrajn li jinkludu diazepam u ibuprofen.
English: ORION PHARMA HELLAS Μ.Ε.Π.Ε Tηλ: + 30 210 9803355
Maltese: Tηλ: + 30 210 9803355
English: Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Entacapone Orion and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Maltese: Is-Sindrome Newrolettiku Malinn (NMS) huwa reazzjoni serja imma rari għal ċerti mediċini, u jista' jseħħ speċjalment meta Entacapone Orion u mediċini oħrajn biex jikkuraw il-marda ta' Parkinson jitwaqqfu ħesrem jew id-doża titnaqqas f'daqqa.
English: Orion Pharma AS Tlf.
Maltese: ORION PHARMA HELLAS Μ.Ε.Π.Ε
English: Usually side effects caused by Entacapone Orion are mild to moderate.
Maltese: Ġeneralment effetti sekondarji kkawżati b'Entacapone Orion ikunu minn ħfief għal moderati.
English: Other medicines and Entacapone Orion
Maltese: Mediċini oħra u Entacapone Orion
English: A small amount of entacapone, the (E)-isomer, is converted to its (Z)-isomer.
Maltese: Ammont żgħir ta' entacapone, l-isomeru (E), jinbidel fl-isomeru (Z) tiegħu.
English: It is characterised by stiffness, muscle twitching, shaking, agitation and confusion, coma, high body temperature, increased heart rate, and unstable blood pressure;
Maltese: muskoli, tregħid u aġitazzjoni, konfużjoni, koma, temperatura għolja tal-ġisem, żieda fir-rata tal-qalb u pressjoni tad-demm mhux stabbli;
English: Each film-coated tablet contains 200 mg entacapone.
Maltese: Kull pillola fiha 200 mg entacapone.
English: yellow iron oxide (E 172), red iron oxide (E 172) and titanium dioxide (E 171).
Maltese: - Il-kisja b'rita fiha polyvinyl alcohol parzjalment idrolizzat, talc, macrogol, soya lecithin, iron oxide isfar (E 172), iron oxide aħmar (E 172) u titanium dioxide (E 171).
English: • abnormal results in liver function test.
Maltese: • testijiet tal-funzjoni tal-fwied jiġu anormali.
English: In two phase III double-blind studies in a total of 376 patients with Parkinson's disease and end-ofdose motor fluctuations, entacapone or placebo was given with each levodopa/dopa decarboxylase inhibitor dose.
Maltese: III, f'total ta' 376 pazjent li jbatu bil-marda ta' Parkinson u b'tibdil fil-moviment fi tmiem it-teħid tad-doża, entacapone jew plaċebo ngħataw flimkien ma' kull doża ta' levodopa/inibitur ta' dopa decarboxylase.
English: Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson's disease.
Maltese: Rabdomijolisi konsegwenza ta' diskineżja severa jew sindrome newroleptiku malinn (NMS) ġew osservati f'każijiet rari f'pazjenti li jsofru bil-marda ta' Parkinson.
English: What Entacapone Orion looks like and contents of the pack Entacapone Orion 200 mg film-coated tablets are brownish-orange, oval tablets with "COMT" engraved on one side.
Maltese: Kif jidher Entacapone Orion u l-kontenut tal-pakkett Entacapone Orion 200 mg pilloli miksija b'rita huma pilloli ovali ta' kulur oranġjo jagħti fil-kannella, b' "COMT" imnaqqxa fuq naħa waħda.
English: - Concomitant use of entacapone and non-selective monoamine oxidase (MAO-A and MAO-B)
Maltese: - L-użu ta' entacapone flimkien ma' inibituri mhux selettivi ta' monoamine oxidase (MAO-A u
English: Erythematous or maculopapular rash
Maltese: Raxx bi ħmura jew makulopapulari
English: Orion Pharma Poland Sp. z o.o.
Maltese: Orion Pharma AB
English: Entacapone may form chelates with iron in the gastrointestinal tract.
Maltese: Entacapone jista' jifforma kelejts mal-ħadid fil-passaġġ gastrointestinali.
English: - A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Maltese: - Passat mediku tas-sindrome newroleptiku malinn (NMS - neuroleptic malignant syndrome)
English: Each tablet contains 200 mg of entacapone,
Maltese: Kull pillola fiha 200 mg ta' entacapone,
English: Entacapone decreases the metabolic loss of levodopa to 3-O-methyldopa (3-OMD) by inhibiting the COMT enzyme.
Maltese: Entacapone inaqqas it-telf metaboliku ta' levodopa għal 3-O-methyldopa (3-OMD) billi jinibixxi l-enzima COMT. Dan iwassal għal AUC ta' levodopa ogħla.
English: Psychiatric disorders Common:
Maltese: Disturbi psikjatriċi Komuni
English: • Neuroleptic Malignant Syndrome (NMS) is a rare severe reaction to medicines used to treat disorders of the nervous system.
Maltese: • Is-Sindrome Newrolettiku Malinn (NMS) huwa reazzjoni serja imma rari għal mediċini użati biex jikkuraw disturbi tas-sistema nervuża.
English: Baseline Week 8-24 10.7±2.2
Maltese: Linja bażi Ġimgħa 8-24 10.
English: Absorption There are large intra- and interindividual variations in the absorption of entacapone.
Maltese: Hemm differenzi intra u interindividwali kbar fl-assorbiment ta' entacapone.
English: ** The incidence rates of myocardial infarction and other ischaemic heart disease events (0.43% and 1.54%, respectively) are derived from an analysis of 13 double-blind studies involving 2,082 patients with end-of-dose motor fluctuations receiving entacapone.
Maltese: 43% u 1.54%, rispettivament) ġejjin minn analiżi ta' 13-il studju double-blind li kienu jinvolvu 2,082 pazjent b'tibdil fil-moviment fi tmiem it-teħid tad-doża mogħtija entacapone.
English: Daily ON time (Mean ±SD)
Maltese: Ħin ON kuljum (Medja ± SD)
English: Entacapone Orion aids levodopa in relieving the symptoms of Parkinson's disease.
Maltese: Entacapone Orion jgħin lil levodopa fis-serħan tas-sintomi tal-marda ta' Parkinson.
English: CARTON AND BOTTLE LABEL
Maltese: KARTUNA U TIKKETTA TAL-FLIXKUN
English: • heart or artery disease events (e.g. chest pain).
Maltese: • episodji ta' mard tal-qalb jew tal-arterji (eż. uġigħ fis-sider).
English: Entacapone is administered orally and simultaneously with each levodopa/carbidopa or levodopa/benserazide dose.
Maltese: Entacapone jittieħed mill-ħalq fl-istess ħin ma' kull doża ta' levodopa/carbidopa jew levodopa/benserazide.
English: • a rare severe muscle disorder (rhabdomyolysis) which causes pain, tenderness and weakness of the muscles and may lead to kidney problems.
Maltese: • disturb rari u gravi fil-muskolu (rabdomijolisi) li jwassal għal uġigħ, sensibbiltà u dgħjufija tal-muskoli u jista' jwassal għal problemi fil-kliewi.
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 such as Entacapone Orion in association with levodopa (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 bħal Entacapone Orion flimkien ma' levodopa (ara sezzjoni 4.4).
English: Entacapone may be used with selegiline (a selective MAO-B inhibitor), but the daily dose of selegiline should not exceed 10 mg.
Maltese: Entacapone jista' jintuża ma' selegiline (inibitur selettiv ta' MAO-B), iżda d-doża ta' kuljum ta' selegiline m'għandhiex taqbeż l-10 mg.
English: • iron supplements.
Maltese: • ħorriqija.
English: • if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Entacapone Orion);
Maltese: • jekk int qed tieħu ċerti mediċini kontra d-depressjoni (saqsi lit-tabib jew lill-ispiżjar tiegħek jekk il-mediċina tiegħek ta' kontra d-depressjoni tistax tittieħed flimkien ma' Entacapone Orion);
English: The metabolism of the medicinal product is slowed in patients with mild to moderate liver insufficiency (Child-Pugh Class A and B), which leads to an increased plasma concentration of entacapone in both the absorption and elimination phases (see section 4.3).
Maltese: Il-metaboliżmu tal-prodott mediċinali jonqos f'pazjenti li għandhom insuffiċjenza minn ħafifa għal moderata tal-fwied (Klassi Child-Pugh A u B), li jagħti lok għal żieda fil-konċentrazzjoni ta' entacapone fil-plażma kemm fil-fażijiet tal-assorbiment kif ukoll f'dawk tal-eliminazzjoni (ara sezzjoni 4.3).
English: Dyskinesia
Maltese: Aġitazzjoni
English: Entacapone Orion 200 mg film-coated tablets entacapone
Maltese: Entacapone Orion 200 mg pilloli miksija b'rita entacapone
English: The maximum recommended dose is 200 mg ten times daily, i.e. 2,000 mg of entacapone.
Maltese: Id-doża massima rrakkomandata hija ta' 200 mg għaxar darbiet kuljum, jiġifieri 2,000 mg ta' entacapone.
English: Caution should be exercised when these medicinal products are used concomitantly with entacapone (see also sections 4.3 and 4.4).
Maltese: Wieħed għandu joqgħod attent meta dawn il-prodotti mediċinali jintużaw flimkien ma' entacapone (ara wkoll sezzjonijiet 4.3 u 4.4).
English: Film-coated tablet (tablet)
Maltese: Disturbi fil-qalb** Komuni
English: • Excessive movements (hyperkinesias), worsening of symptoms of Parkinson´s disease,
Maltese: • Moviment eċċessiv (iperkineżji), is-sintomi tal-marda ta' Parkinson imorru għall-agħar,
English: Entacapone Orion is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Maltese: Entacapone Orion jittieħed flimkien ma' mediċini li fihom levodopa (taħlitiet ta' levodopa/carbidopa jew taħlitiet ta' levodopa/benserazide).
English: • Inability to resist the impulse to perform an action that could be harmful, which may include:
Maltese: • Nuqqas ta' ħila li tirreżisti l-impuls li twettaq azzjoni li tista' tkun ta' ħsara, li tista' tinkludi:
English: • if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure);
Maltese: • jekk għandek tumur fil-glandola adrenali (magħruf bħala fejokromoċitoma; dan jista' jżid irriskju ta' żieda fil-pressjoni tad-demm b'mod sever);
English: According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Maltese: Skont studji in vitro mhuwiex antiċipat li jkun hemm spostament sinifikanti f'konċentrazzjonijiet terapewtiċi tal-prodotti mediċinali.
English: • Inflammation of the colon (colitis), inflammation of the liver (hepatitis) with yellowing of the skin and whites of the eyes;
Maltese: • Infjammazzjoni tal-musrana (kolite), infjammazzjoni tal-fwied (epatite) li twassal biex il-ġilda u l-abjad tal-għajnejn jisfaru;
English: Film-coating:
Maltese: Mhux magħruf:
English: Suddenly stopping Entacapone Orion and other medicines to treat Parkinson´s disease may result in unwanted side effects.
Maltese: Jekk tieqaf ħesrem tieħu Entacapone Orion u mediċini oħrajn biex jikkuraw il-marda ta' Parkinson jista' jwassal għal effetti sekondarji mhux mixtieqa.
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħruf (ma tistax tingħata stima tal-frekwenza mid-dejta disponibbli):
English: Urine discoloration General disorders and administration site conditions Common:
Maltese: Bidla fil-kulur tal-awrina Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni:
English: To reduce levodopa-related dopaminergic adverse reactions, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment, according to the clinical condition of the patient (see sections 4.2 and 4.8).
Maltese: Sabiex jitnaqqsu effetti avversi dopaminerġiċi relatati ma' levodopa, ħafna drabi jkun hemm bżonn li jitbiddel id-dożaġġ ta' levodopa fl-ewwel ġranet jew fl-ewwel ġimgħat talkura b'entacapone, skont il-kondizzjoni klinika tal-pazjent (ara sezzjonijiet 4.2 u 4.8).
English: Skin and subcutaneous tissue disorders Rare:
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Rari:
English: In addition, Entacapone Orion taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep.
Maltese: Allura, tiħux Entacapone Orion u supplimenti ta' ħadid fl-istess ħin.
English: If you experience such effects at the start of treatment with Entacapone Orion you should contact your doctor who may decide to adjust your dosage of levodopa.
Maltese: Għaldaqstant, l-użu ta' Entacapone Orion fit-tfal jew adolexxenti ma jistax ikun irrakkomandat.