FrancophonIA/ELRC3.0 huggingface dataset:
English: The (Z)-isomer and traces of other metabolites account for the remaining 5%.
Maltese: L-iżomer (Z) u traċċi ta' metaboli oħra jikkonstitwixxu l-5% l-oħra.
English: Entacapone may aggravate levodopa-induced orthostatic hypotension.
Maltese: Entacapone jista' jiggrava l-ipotensjoni ortostatika kkawżata minn levodopa.
English: methyl transferase (COMT), e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine,dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
Maltese: noradrenaline, dopamine, dobutamine, alpha-methyldopa u apomorphine (ara wkoll sezzjoni 4.5).
English: Entacapone Teva is available in HDPE tablet containers with polypropylene screw caps with desiccant insert containing 30, 60, 100 or 175 film-coated tablets.
Maltese: Entacapone Teva hu disponibbli f'kontenituri tal-pilloli tal-HDPE b'għatjien bil-kamini tal-polypropylene, b'desiccant insert, li jkun fihom 30, 60, 100 jew 175 pilloli miksija b'rita.
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 ta' l-albumina umana, ma' fejn jeħlu wkoll diversi prodotti mediċinali oħrajn li jinkludu diazepam u ibuprofen.
English: After absorption from the gastrointestinal tract, entacapone is rapidly distributed to the peripheral tissues with a distribution volume of 20 litres at steady state (Vdss).
Maltese: Wara l-assorbiment mill-passaġġ gastrointestinali, entacapone jinfirex malajr fit-tessuti periferali b'volum ta' distribuzzjoni ta' 20 litru fi stat fiss (Vdss).
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Hija tippermetti monitoraġġ kontinwu tal-bilanċ tal-benefiċċju / riskju tal-prodott mediċinali.
English: Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 ~4 μM).
Maltese: turi li entacapone jinibixxi ċ-ċitokromju P450 2C9 (IC50 ∼4 µM).
English: (≥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'
English: HDPE tablet containers with polypropylene screw caps with desiccant insert containing 30, 60, 100 or 175 film-coated tablets.
Maltese: Kontenituri tal-pilloli tal-HDPE b'għotjien bil-kamini tal-polyethylene b'desiccant inserit li jkun fih 30, 60, 100 jew 175 pillola miksija b'rita.
English: Approximately 10-20% is excreted in urine.
Maltese: Madwar 10-20% titneħħa fl-awrina.
English: How to store Entacapone Teva Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Patients with hepatic impairment See section 4.3.
Maltese: Pazjenti b'indeboliment tal-fwied Ara sezzjoni 4.3.
English: Patients should be regularly monitored for the development of impulse control disorders.
Maltese: Il-pazjenti għandhom ikunu mmonitorati regolarment għal żvilupp ta' disturbi tal-kontroll tal-impulsi.
English: Entacapone Teva film-coated tablets are light brown, biconvex ellipse-shaped with approximately 18 mm length and 10 mm width, embossed with “E200” on one side and plain on the other side.
Maltese: Pilloli miksija b'rita ta' lewn kannella ċar, mżaqqin, b'forma elliptika, b'tul ta' madwar 18 mm u wisa' ta' 10 mm, imnaqqxa b'‘E200' fuq naħa waħda, u xejn fuq in-naħa l-oħra.
English: The % change from baseline in OFF time was -24% in the entacapone group and 0% in the placebo group in study I. The corresponding figures in study II were -18% and -5%.
Maltese: Il-figuri korrispondenti fi Studju II kienu -18% u -5%.
English: The major part (95%) of the product excreted in urine is conjugated with glucuronic acid.
Maltese: Il-parti l-kbira (95%) tal-prodott imneħħi fl-awrina huwa mgħaqqad ma' glucuronic acid.
English: Absorption There are large intra- and interindividual variations in the absorption of entacapone.
Maltese: Assorbiment Hemm differenzi intra u interindividwali kbar fl-assorbiment ta' entacapone.
English: Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Entacapone Teva 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 Teva u mediċini oħrajn biex jikkuraw il-marda ta' Parkinson jitwaqqfu ħesrem jew id-doża titnaqqas f'daqqa.
English: The total clearance of entacapone is about 800 ml/min.
Maltese: It-tneħħija totali ta' entacapone mill-ġisem hija ta' madwar 800 ml/min.
English: In repeated dose toxicity studies, anaemia most likely due to iron chelating properties of entacapone was observed.
Maltese: Fi studji dwar it-tossiċità minn dożi ripetuti, ġiet innutata anemija, probabbilment dovuta għall-kelazzjoni ta' entacapone mal-ħadid.
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: F'żewġ studji tal-Fażi III double-blind, f'total ta' 376 pazjent li jbatu bil-marda ta' Parkinson u b'tibdil fil-moviment fi tmiem it-teħid tad-doża, l-entacapone jew il-plaċebo ngħataw flimkien ma' kull doża ta' levodopa/inibitur tad-dopa decarboxylase.
English: One 200 mg tablet is taken with each levodopa/dopa decarboxylase inhibitor dose.
Maltese: Pillola waħda ta' 200 mg għandha tittieħed ma' kull doża ta' levodopa/inibitur ta' dopa decarboxylase.
English: - A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Maltese: - Passat mediku tas-sindrome newroleptiku malinn (NMS) u/jew rabdomajoliżi mhux trawmatika. 4.4
English: Entacapone Teva 200 mg film-coated tablets entacapone oral use
Maltese: Entacapone Teva 200 mg pilloli miksija b'rita entacapone użu orali
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 (magħrufa bħala fejokromoċitoma, din tista' żżid ir riskju ta' żieda fil-pressjoni tad-demm b'mod sever);
English: Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson's disease.
Maltese: Twissijiet speċjali u prekawzjonijiet għall-użu Rabdomajoliżi konsegwenza ta' diskineżja severa jew sindrome newroleptiku malinn (NMS) ġew osservati f'każijiet rari f'pazjenti li jsofru bil-marda ta' Parkinson.
English: Entacapone decreases the metabolic loss of levodopa to 3O-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: 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 tal-MAO-B), iżda d-doża ta' kuljum ta' selegiline m'għandhiex taqbeż l-10 mg.
English: Erythematous or maculopapular rash
Maltese: Awrina titlef il-kulur
English: Diarrhoea, abdominal pain, dry mouth, constipation, vomiting
Maltese: • antidipressanti: desipramine, maprotiline, venlafaxine, paroxetine;
English: Dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
Maltese: F'informazzjoni miġbura minn studji kliniċi li involvew 406 pazjenti li kienu qed jieħdu l-prodott mediċinali u 296 pazjent li kienu qed jieħdu plaċebo, irriżulta li diskineżja (27%), dardir (11%), dijarea (8%), uġigħ fl-addome (7%) u nixfa fil-ħalq (4.2%), ġew irrappurtati bi frekwenza sostanzjalment akbar meta ntuża entacapone milli meta ntuża plaċebo.
English: prolonged muscle cramps (dystonia); - being sick (vomiting), diarrhoea, abdominal pain, constipation, dry mouth; - dizziness, tiredness, increased sweating, fall; - hallucinations (seeing/hearing/feeling/smelling things that are not really there), sleeplessness,
Maltese: bugħawwieġ għal tul ta' ħin (distonja); - tkun imqalla' (tirremetti), dijarea, uġigħ addominali, stitikezza, ħalq xott; - sturdament, għeja, żieda fl-għaraq, taqa'; - alluċinazzjonijiet (tara/tisma'/tħoss/ixxomm affarijiet li mhux vera qegħdin hemm), nuqqas ta'
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (30, 60, 100 or 175 film-coated tablets)
Maltese: KARTUNA TA' BARRA (30, 60, 100 jew 175 pillola miksija b'rita)
English: 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets 175 film-coated tablets
Maltese: 30 pillola miksija b'rita 60 pillola miksija b'rita 100 pillola miksija b'rita 175 pillola miksija b'rita
English: Management of acute overdose is symptomatic.
Maltese: Doża eċċessiva akuta tiġi ttrattata skont is-sintomi.
English: The post-marketing data include isolated cases of overdose in which the reported highest daily dose of entacapone has been 16,000 mg.
Maltese: Minn tagħrif miksub wara t-tqegħid tal-mediċina fis-suq kien hemm każijiet iżolati ta' doża eċċessiva fejn l-ogħla doża ta' entacapone kuljum kienet ta' 16,000 mg.
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: Very rare (may affect up to 1 in 10,000 people): - Agitation; - decreased appetite, weight loss; - hives.
Maltese: Rari ħafna (jista' jaffettwa sa persuna waħda minn kull 10,000) - Aġitazzjoni;
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) ġejjin minn analiżi ta' 13-il studju double-blind li kienu jinvolvu 2082 pazjent mogħtija entacapone b'tibdil fil-moviment fi tmiem it-teħid tad-doża.
English: Usually side effects caused by Entacapone Teva are mild to moderate.
Maltese: Ġeneralment effetti oħra kkawżati b'Entacapone Teva ikunu minn ħfief għal moderati.
English: The pharmacokinetic properties of entacapone are similar in both young and elderly adults.
Maltese: Il-karatteristiċi farmakokinetiċi ta' entacapone huma simili kemm fiż-żgħażagħ kif ukoll fl-adulti.
English: Entacapone enhances the effects of levodopa.
Maltese: Entacapone ikattar l-effetti ta' levodopa.
English: Each tablet contains 200 mg of entacapone
Maltese: Kull pillola fiha 200 mg ta' entacapone
English: Film-coating
Maltese: Karatteristiċi fil-pazjenti
English: Consequently, adverse dopaminergic reactions may be more frequent when entacapone is added to levodopa/benserazide treatment (see also section 4.8).
Maltese: Għalhekk reazzjonijiet dopaminerġiċi mhux mixtieqa jistgħu jkunu aktar spissi meta jiżdied entacapone mal-kura b'levodopa/benserazide (ara wkoll sezzjoni 4.8).
English: How to take Entacapone Teva
Maltese: X'fih Entacapone Teva
English: Daily ON time (Mean ±SD) Study I: Daily On time (h)
Maltese: Tabella 2: Ħin ON kuljum (Medja ± SD) Studju I: Ħin ON kuljum (sigħat)
English: Usually the adverse reactions caused by entacapone are mild to moderate.
Maltese: Normalment ir-reazzjonijiet avversi kkawżati b'entacapone ivarjaw minn ħfief għal moderati.
English: 60 film-coated tablets 100 film-coated tablets 175 film-coated tablets
Maltese: 60 pillola miksija b'rita 100 pillola miksija b'rita 175 pillola miksija b'rita
English: Uncommon:
Maltese: Komuni ħafna:
English: Entacapone inhibits the COMT enzyme mainly in peripheral tissues.
Maltese: Entacapone jinibixxi l-enzima COMT prinċipalment fit-tessuti periferali.
English: It is characterised by stiffness, muscle twitching, shaking, agitation and confusion, coma, high body temperature, increased heart rate and unstable blood pressure; - a rare severe muscle disorder (rhabdomyolysis) which causes pain, tenderness and weakness of the muscles and may lead to kidney problems.
Maltese: Il-karatteristiċi tiegħu huma riġidità, ġbid ta' muskoli, tregħid, aġitazzjoni u konfużjoni, koma, temperatura għolja tal-ġisem, żieda fir-rata tal-qalb u pressjoni tad-demm mhux stabbli;
English: Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Maltese: Entacapone huwa indikat biex jittieħed flimkien ma' sustanzi standard ta' levodopa/benserazide jew levodopa/carbidopa li jintużaw f'pazjenti adulti li għandhom il-marda ta' Parkinson jew tibdil filmoviment fit-tmiem tat-teħid tad-dożi mediċinali, li ma jistgħux jiġu kkontrollati b'dawk is-sustanzi kkombinati.
English: Very common (may affect more than 1 in 10 people): - Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias); - feeling sick (nausea); - harmless reddish-brown discoloration of urine.
Maltese: Komuni ħafna (jista' jaffettwa aktar minn persuna waħda minn kull 10) - Moviment mhux kontrollabbli b'diffikultà fit-twettiq ta' movimenti volontarji (diskineżji); - tħossok imqalla' (dardir); - tibdil fil-kulur tal-awrina għal kannella jagħti fl-aħmar li ma jagħmilx ħsara
English: Entacapone Teva 200 mg film-coated tablets entacapone
Maltese: Entacapone Teva 200 mg pilloli miksijin b'rita entacapone
English: Do not use this medicine after the expiry date which is stated on the carton and tablet container label after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq it-tikketta talkontenitur tal-pilloli wara EXP.
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%
English: According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Maltese: Skond studji in vitro mhuwiex antiċipat li jkun hemm spostament sinifikanti f'konċentrazzjonijiet terapewtiċi tal-prodotti mediċinali.
English: If entacapone treatment is discontinued, 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 il-kura b'entacapone titwaqqaf, ikun hemm bżonn li jinbidel id-dożaġġ ta' trattamenti oħra għal kontra l-marda ta' Parkinson, speċjalment ta' levodopa, sabiex jintlaħaq livell suffiċjenti ta' kontroll tas-sintomi ta' Parkinson.
English: Entacapone Teva aids levodopa in relieving the symptoms of Parkinson's disease.
Maltese: Entacapone Teva jgħin lil levodopa fis-serħan tas-sintomi tal-marda ta' Parkinson.
English: Entacapone is administered orally and simultaneously with each levodopa/carbidopa or levodopa/benserazide dose.
Maltese: Metodu ta' kif għandu jingħata Entacapone jittieħed mill-ħalq fl-istess ħin ma' kull doża ta' levodopa/carbidopa jew levodopa/benserazide.
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 also section 4.7).
Maltese: L-użu ta' entacapone flimkien ma' levodopa ġie assoċjat man-ngħas u episodji ta' rqad f'daqqa f'pazjenti li jbatu bil-marda ta' Parkinson u għalhekk għandha tintuża kawtela meta wieħed ikun qed isuq jew iħaddem magni (ara wkoll sezzjoni 4.7).
English: In doses of 1,400 to 2,000 mg per day, the following side effects are more common: - Uncontrollable movements; - nausea; - abdominal pain.
Maltese: Fil-każ ta' dożi ta' bejn 1,400 u 2,000 mg kuljum, l-effetti sekondarji li ġejjin huma aktar komuni:
English: Each film-coated tablet contains 200 mg of entacapone.
Maltese: Kull pillola miksija b'rita fiha 200 mg ta' entacapone.
English: Parkinsonism aggravated, dizziness, dystonia, hyperkinesia
Maltese: Dijarea, uġigħ fl-addome, ħalq xott, stitikezza, rimettar
English: Patients being treated with entacapone in association with levodopa and presenting with somnolence and/or sudden sleep onset episodes must be instructed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes have resolved (see also section 4.4).
Maltese: Pazjenti li jkunu qed jiġu kkurati b'entacapone flimkien ma' levodopa u li jaqbadhom in-ngħas u/jew episodji ta' rqad għal għarrieda, għandhom jingħataw istruzzjonijiet biex ma jsuqux u ma jagħmlux attivitajiet fejn nuqqas ta' viġilanza jista' jpoġġi lilhom jew lill-oħrajn f'riskju ta' korriment serju jew mewt (eż. tħaddim ta' magni), sakemm dawn l-episodji rikorrenti jgħaddu (ara wkoll sezzjoni 4.4).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Maltese: Professjonisti tas-saħħa huma mitluba li jirrappurtaw kwalunkwe reazzjoni avversa ħażina suspettata permezz tas-sistema ta 'rappurtar nazzjonali elenkata elenkati fl-Appendiċi V
English: It is estimated that 80-90% of the dose is excreted in faeces, although this has not been confirmed in man.
Maltese: Huwa stmat li minn 80 sa 90% tad-doża titneħħa mal-ippurgar, għalkemm din l istatistika ma ġietx ikkonfermata fil-bniedem.
English: Baseline
Maltese: iperkineżja
English: Of the metabolites found in urine only about 1% have been formed through oxidation.
Maltese: Mill-metaboli misjuba fl-awrina madwar 1% biss ikunu ġew iffurmati permezz tal-ossidazzjoni.
English: Renal impairment does not affect the pharmacokinetics of entacapone.
Maltese: Indeboliment tal-kliewi ma jaffettwax il-farmakokinetika ta' entacapone.
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, b'rabdomajoliżi u ipertermja, hija kkaratterizzata b'sintomi ta' diffikultajiet fiċ-ċaqliq (riġidità, majoklonus, tregħid), bidliet fl-istat mentali (eż. aġitazzjoni, konfużjoni, koma), ipertermija,
English: Characteristics in patients
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: - Keep this leaflet.
Maltese: - ħorriqija.
English: - Hepatic impairment.
Maltese: - uġigħ addominali.
English: Talk to your doctor or pharmacist before taking Entacapone Teva: if you have ever had a heart attack or any other diseases of the heart; if you are taking a medicine which may cause dizziness or light-headedness (low blood pressure) when rising from a chair or bed; if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon; if you experience diarrhoea, monitoring of your weight is recommended in order to avoid potentially excessive weight loss;
Maltese: Minn meta tqiegħed fis-suq, ġew irrappurtati każijiet rari ta' NMS speċjalment meta endacopone u prodotti mediċinali dopaminerġiċi oħra li kienu qed jittieħdu flimkien miegħu, twaqqfu għal għarrieda.
English: Hepatitis with mainly cholestatic features (see section 4.4.)
Maltese: CYP2C19) (ara sezzjoni 4.5). Eliminazzjoni
English: 1 h 20 min CI95% 45 min, 1 h 56 min
Maltese: CI95% 45 min, siegħa u 56 min Studju II: Proporzjon ta' Ħin ON kuljum (%)
English: Adverse drug reactions* Psychiatric disorders
Maltese: Tabella 1* - Reazzjonijiet avversi tal-mediċina
English: Urine discoloration
Maltese: Diskineżja
English: Nervous system disorders
Maltese: Disturbi psikjatriċi
English: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tél/Tel: +49 731 402 02
Maltese: Luxembourg/Luxemburg ratiopharm GmbH .
English: A small amount of entacapone, the (E)-isomer, is converted to its (Z)-isomer.
Maltese: Ammont żgħir ta' entacapone, l-iżomer (E), jinbidel fl-iżomer (Z) tiegħu.
English: Common (may affect up to 1 in 10 people): - Excessive movements (hyperkinesias), worsening of symptoms of Parkinson´s disease,
Maltese: Komuni (jista' jaffettwa sa persuna waħda minn kull 10) - Moviment eċċessiv (iperkineżji), is-sintomi tal-marda ta' Parkinson imorru għall-agħar,
English: Entacapone Teva 200 mg film-coated tablets
Maltese: Entacapone Teva 200 mg pilloli miksijin b'rita
English: Neither NMS nor rhabdomyolysis have been reported in association with entacapone treatment from controlled trials in which entacapone was discontinued abruptly.
Maltese: Ir-rappurtar ta 'reazzjonijiet suspettati mhux mixtieqa Ir-rappurtar ta'reazzjonijiet avversi ssuspettati wara awtorizzazzjoni tal-prodott mediċinali huwa importanti.
English: - Concomitant use of entacapone and non-selective monoamine oxidase (MAO-A and MAO-B)
Maltese: - Fejokromoċitoma - L-użu ta' entacapone flimkien ma' inibituri mhux selettivi ta' monoamine oxidase (MAO-A u
English: Hepatic function tests abnormal
Maltese: Testijiet tal-funzjoni tal-fwied jiġu anormali
English: The peak concentration (Cmax) in plasma is usually reached about one hour after ingestion of a 200 mg entacapone tablet.
Maltese: Il-konċentrazzjoni massima (Cmax) fil-plażma ġeneralment tintlaħaq madwar siegħa wara li wieħed ikun ħa pillola ta' entacapone ta' 200 mg.
English: Caution should be exercised when these medicinal products are used concomitantly with entacapone (see also sections 4.3 and 4.4).
Maltese: (ara wkoll sezzjonijiet 4.3 u 4.4).
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1. - Indeboliment tal-fwied
English: Entacapone should only be used in combination with levodopa/benserazide or levodopa/carbidopa.
Maltese: aktar minn preparazzjonijiet standard ta' levodopa/carbidopa.
English: In clinical studies, adverse dopaminergic 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, irriżulta li reazzjonijiet dopaminerġiċi avversi (eż. diskineżja) kienu aktar komuni f'pazjenti li ħadu entacapone u agonisti ta' dopamine (bħal bromocriptine), selegiline jew amantadine, milli f'dawk il-pazjenti li rċevew plaċebo ma' din it-taħlita ta' mediċini.
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 titbiddel id-doża ta' levodopa fl-ewwel ġranet jew fl-ewwel ġimgħat tal kura b'levodopa, skont il-kundizzjoni klinika tal-pazjent (ara sezzjoni 4.2 u 4.8).