FrancophonIA/ELRC3.0 huggingface dataset:
English: Diarrhoea: In clinical trials, diarrhoea developed in 16 % and 18 % of patients receiving Tasmar 100 mg tid and 200 mg tid respectively, compared to 8 % of patients receiving placebo.
Maltese: Fi provi kliniċi, żviluppat dijarrea f'16% u 18% tal-pazjenti li kienu qegħdin jingħataw Tasmar 100 mg tid u 200 mg tid rispettivament, imqabbla mat-8% tal-pazjenti li kienu qegħdin jingħataw plaċebo.
English: Tasmar should not be prescribed until there has been a complete informative discussion of the risks with the patient.
Maltese: Tasmar m'għandux jiġi preskritt sakemm ma tkun saret diskussjoni informattiva kompleta dwar ir-riskji mal-pazjent.
English: In an interaction study, tolcapone did not change the pharmacokinetics of tolbutamide.
Maltese: Fi studju dwar l-interazzjonijiet, tolcapone ma bidilx il-farmakokinetiċi ta' tolbutamide.
English: Increases to more than three times the upper limit of normal (ULN) in alanine aminotransferase (ALT)occurred in 1 % of patients receiving Tasmar 100 mg three times daily, and 3 % of patients at 200 mg three times daily.
Maltese: Żjidiet għal aktar minn tliet darbiet daqs il-limitu massimu tan-normal (ULN) fl-alanine aminotransferase (ALT) dehru f'1% tal-pazjenti li ngħataw Tasmar 100 mg tliet darbiet kuljum, u fi 3% tal-pazjenti fuq 200 mg tliet darbiet kuljum.
English: During dosing with Tasmar 200 mg three times daily, erythrocyte COMT inhibition at trough is 30 % to 45 %, with no development of tolerance.
Maltese: Waqt id-doża ta' Tasmar 200 mg tliet darbiet kuljum, l-inibizzjoni ta' eritroċit COMT fil-kontenitur hija ta' 30% sa 45%, mingħajr żvilupp ta' tolleranza.
English: Patients with renal impairment (see section 5.2)
Maltese: Pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2)
English: However, the relationship of renal function and tolcapone pharmacokinetics has been investigated using population pharmacokinetics during clinical trials.
Maltese: Madanakollu, ir-relazzjoni bejn il-funzjoni tal-kliewi u l-farmakokinetiċi ta'tolcapone ġiet investigata fuq farmakokinetiċi tal-popolazzjoni waqt provi kliniċi.
English: No effects were seen on the pharmacokinetics of the COMT substrate carbidopa.
Maltese: Ma dehru l-ebda effetti fuq ilfarmakokinetiċi ta' carbidopa substrata tal-COMT.
English: “TASMAR” and “100” are engraved on one side.
Maltese: Fuq naħa waħda hemm imnaqqxa “TASMAR” u “100”.
English: Plasma levels of 3OMD were markedly and dose-dependently decreased by tolcapone when given with levodopa/AADC-I (aromatic amino acid decarboxylase - inhibitor) (benserazide or carbidopa).
Maltese: Il-livelli ta' plażma ta' 3-OMD tnaqqsu, b'mod evidenti u indipendentement mid-doża, b'tolcapone meta dan kien mogħti ma' levodopa/AADC-I (aromatic amino acid decarboxylase - inhibitor) (benserazide jew carbidopa).
English: Therefore, clinically relevant interactions involving cytochrome CYP2C9 appear unlikely.
Maltese: Għalhekk, m'humiex probabbli interazzjonijiet klinikament relevanti li jinvolvu ċ-ċitokromju CYP2C9.
English: Hypokinesia
Maltese: Ipokinessija
English: When Tasmar is administered together with levodopa, it increases the relative bioavailability (AUC) of levodopa approximately twofold.
Maltese: Meta Tasmar tingħata flimkien ma' levodopa, iżżid il-biodisponibilità (AUC) relattiva ta' levodopa b'madwar id-doppju.
English: Tasmar can be combined with all pharmaceutical formulations of levodopa/benserazide and levodopa/carbidopa (see also section 4.5).
Maltese: Tasmar jista' jittieħed mal-formulazzjonijiet farmaċewtiċi kollha ta' levodopa/benserazide u levodopa/carbidopa (ara ukoll sezzjoni 4.5).
English: The t1/2 of tolcapone is approximately 2 hours.
Maltese: Il- t1/2 ta'tolcapone huwa ta' madwar sagħtejn.
English: Tasmar is available in PVC/PE/PVDC blisters (pack sizes of 30 and 60 film-coated tablets) and in amber glass bottles without desiccant (pack sizes of 30, 60,100 and 200 film-coated tablets).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Tasmar hija disponibbli f'folji PVC/PE/PVDC (daqsijiet tal-pakkett ta' 30 u ta' 60 pillola miksija b'rita) u fi fliexken tal-ħġieġ ambra mingħajr dessikant (daqsijiet tal-pakkett ta' 30, 60, 100 u 200 pillola miksija b'rita).
English: Levodopa adjustments during Tasmar treatment:
Maltese: Aġġustamenti fil-levodopa waqt trattament b'Tasmar:
English: In the therapeutic range, tolcapone pharmacokinetics are linear and independent of levodopa/AADC-I (benserazide or carbidopa) coadministration.
Maltese: Fil-firxa terapewtika, il-farmakokinetika ta'tolcapone hija linejari u indipendenti millamministrazzjoni flimkien mal-levodopa/AADC-I (benserazide jew carbidopa).
English: This may include: o
Maltese: NUMRU(I)
English: Each film-coated tablet contains 200 mg tolcapone tolcapone 200 mg
Maltese: Kull pillola miksija b'rita fiha 200mg tolcapone Tolcapone 200 mg
English: EU/1/97/044/004 30 tablets EU/1/97/044/005 60 tablets
Maltese: EU/1/97/044/004 30 pillola EU/1/97/044/005 60 pillola
English: MAO inhibitors: Tasmar should not be given in conjunction with non-selective monoamine oxidase (MAO) inhibitors (e.g. phenelzine and tranylcypromine).
Maltese: Tasmar ma għandux jingħata flimkien ma' monoamine oxidase mhux selettiv (MAO) inibituri (eż. phenelzine u tranylcypromine).
English: In vitro experiments have shown that tolcapone binds mainly to serum albumin.
Maltese: Esperimenti in vitro urew li tolcapone jorbot l-aktar ma' l-albumin tas-serum.
English: The only adverse reaction commonly leading to discontinuation of Tasmar in clinical trials was diarrhoea (see section 4.4).
Maltese: L-unika reazzjoni avversa li normalment twassal għall-waqfien ta' Tasmar fi provi kliniċi kienet iddijarrea (ara sezzjoni 4.4).
English: Date of first authorisation: 27 August 1997 Renewal of the authorisation: 31 August 2004 Date of latest renewal: 21 July2014
Maltese: Tiġdid tal-awtorizzazzjoni: 31 ta' Awwissu 2004
English: EU/1/97/044/001 30 tablets EU/1/97/044/002 60 tablets
Maltese: EU/1/97/044/001 30 pillola EU/1/97/044/002 60 pillola
English: Tolcapone is a low-extraction-ratio drug (extraction ratio = 0.15), with a moderate systemic clearance of about 7 L/h.
Maltese: Tolcapone hija mediċina bi proporzjon ta' estrazzjoni baxx (proporzjon ta' estrazzjoni = 0.15), bi tneħħija sistemika moderata ta' madwar 7 L/h.
English: Tasmar 100 mg (only applicable for the outer packaging
Maltese: Tasmar 100mg (applikabli biss għall-pakketti ta' barra)
English: It is available in blisters in pack sizes of 30 and 60 tablets and in glass bottles in pack sizes of 30, 60 ,100 and 200 filmcoated tablets.
Maltese: Huwa disponibbli f'folji f'pakketti ta' 30 u 60 pillola u fi flixkien tal-ħġieġ f'pakketti ta' 30, 60, 100 u 200 pillola miksija b'rita.
English: Carcinogenesis, mutagenesis: 3 % and 5 % of rats in the mid- and high- dose groups, respectively, of the 24-month carcinogenicity study were shown to have renal epithelial tumours (adenomas or carcinomas).
Maltese: Karċinoġenesi, mutaġenesi: 3% u 5% tal-firien fil-gruppi ta' doża moderata u dik għolja, rispettivament, fl-istudju fuq 24 xahar dwar il-karċinoġeniċità dehru li għandhom tumuri epitelijali filkliewi (adenoma jew karċinoma).
English: Warfarin: Since clinical information is limited regarding the combination of warfarin and tolcapone, coagulation parameters should be monitored when these drugs are co-administered.
Maltese: Minħabba l-limitazzjoni fl-informazzjoni klinika dwar l-interazzjoni ta' warfarina u tolcapone, meta dawn il-mediċini jingħataw f'daqqa, il-parametri ta' koagulazzjoni għandhom ikunu monitorati.
English: Treatment with non-selective mono amino oxidase (MAO) inhibitors
Maltese: • Trattament flimkien mal-inhibituri mhux selettivi tal-mono amino ossidażi (MAOI)
English: Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a firstline adjunct therapy to levodopa/benserazide or levodopa/carbidopa (see sections 4.4 and 4.8).
Maltese: Minħabba r-riskju potenzjalment fatali ta' dannu akut fil-fwied, Tasmar m'għandux jiġi kkunsidrat bħala l-ewwel terapija aġġunta għal-levodopa/benserazide jew levodopa/carbidopa (ara sezzjoni 4.4 u 4.8).
English: With 200 mg tolcapone, maximum inhibition of erythrocyte COMT activity is, on average, greater than 80 %.
Maltese: B'200 mg ta' tolcapone, l-inibizzjoni massima ta' l-attività ta' l-eritroċit COMT tkun, bħala medja, aktar minn 80%.
English: Tasmar may cause rare but potentially fatal liver injury.
Maltese: Tasmar jista' jikkawża ħsara rari iżda potenzjalment fatali fil-fwied.
English: Tolcapone's effect on levodopa pharmacokinetics is similar with all pharmaceutical formulations of levodopa/benserazide and levodopa/carbidopa; it is independent of levodopa dose, levodopa/AADC-I (benserazide or carbidopa) ratio and the use of sustained-release formulations.
Maltese: L-effett ta'tolcapone fuq il-farmakokinetiċi ta' levodopa huwa simili fuq il-formulazzjonijiet farmaċewtiċi kollha ta' levodopa/benserazide u levodopa/karbidopa; huwa indipendenti mid-doża ta' levodopa, il-proporzjon levodopa/AADC-I (benserazide jew karbidopa) u l-użu ta' formulazzjonijiet li jerħu il-mediċina b'mod modifikat..
English: Treatment should be immediately discontinued if ALT and/or AST exceed the upper limit of normal or if symptoms or signs suggesting the onset of hepatic failure (persistent nausea, fatigue, lethargy, anorexia, jaundice, dark urine, pruritus, right upper quadrant tenderness) develop.
Maltese: It-trattament għandu jitwaqqaf immedjatament jekk l-ALT u/jew l-AST jeċċedu l-limitu ta' fuq għan-normal jew jekk jiżviluppaw sintomi jew sinjali li jissuġġerixxu nuqqas epatiku (nawżea persistenti, għeja, letarġija, anoressija, suffejra, urina skura, ħakk, u rtubija fil-kwadrant lemini tal-parti ta' fuq).
English: The following suggestions are based on pharmacological considerations and have not been evaluated in clinical trials.
Maltese: Is-suġġerimenti segwenti huma bbażati fuq konsiderazzjonijiet farmakoloġiċi u ma ġewx evalwati fi provi kliniċi.
English: However, Tasmar, as a COMT inhibitor, is known to increase the bioavailability of the co-administered levodopa.
Maltese: Tasmar, bħala inibitur ta' COMT, huwa magħruf li jżid il-bio-disponabilitá tal-levodopa koamministrata.
English: Outer Carton and blister packs, 30 and 60 film-coated tablets
Maltese: Kartuna ta' barra u pakketti b'folji, 30 u 60 pillola miksija b'rita
English: Food delays and decreases the absorption of tolcapone, but the relative bioavailability of a dose of tolcapone taken with a meal is still 80 % to 90 %.
Maltese: L-ikel jista' jdewwem jew jnaqqas l-assorbiment tat-tolcapone, iżda l-biodisponibilità relattiva ta' doża ta' tolcapone meħuda ma' l-ikel xorta hija ta' 80% sa 90%.
English: For the treatment of Parkinson´s disease, Tasmar is used together with the medicinal product levodopa (as levodopa/benserazide or levodopa/carbidopa).
Maltese: Għall-kura tal-marda ta' Parkinson, Tasmar jintuża flimkien mal-prodott mediċinali levodopa (bħala levodopa/benserazide jew levodopa/carbidopa).
English: Via Felice Casati, 20 20124 Milano Tel: +39 039 73901
Maltese: Milano Tel: +39 039 73901
English: Tasmar 200 mg film-coated tablets Tolcapone
Maltese: Tasmar 200 mg pilloli miksija b'rita Tolcapone
English: Studies in healthy volunteers have shown that tolcapone reversibly inhibits human erythrocyte COMT activity after oral administration.
Maltese: Studji fuq voluntiera b'saħħithom urew li wara l-amministrazzjoni orali tolcapone jinibixxi riversibilment l-attività ta' eritroċit COMT uman.
English: Tasmar is available in PVC/PE/PVDC blisters (pack sizes of 30 and 60 film-coated tablets) and in amber glass bottles without desiccant (pack sizes of 100 film-coated tablets).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Tasmar hija disponibbli f'folji PVC/PE/PVDC (daqsijiet tal-pakkett ta' 30 u ta' 60 pillola miksija b'rita) u fi fliexken tal-ħġieġ ambra mingħajr dessikant (daqsijiet tal-pakkett ta' 100 pillola miksija b'rita).
English: Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti b'problemi ta' intolleranza tal-galactose ereditarja, d-defiċjenza tal-Lapp lactose jew malassorbazzjoni tal-glucose-galactose ma għandhomx jieħdu din il-mediċina.
English: Tasmar 100 mg film-coated tablets Tolcapone
Maltese: Tasmar 100 mg pilloli miksija b'rita Tolcapone
English: 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets 200 film-coated tablets
Maltese: 30 pillola miksija b'rita 60 pillola miksija b'rita 100 pillola miksija b'rita 200 pillola miksija b'rita
English: Tasmar therapy should only be initiated by physicians experienced in the management of advanced Parkinson's disease, to ensure an appropriate risk-benefit assessment.
Maltese: It-terapija Tasmar għandha tinbeda biss minn tobba b'esperjenza fil-kontroll tal-marda Parkinson's avvanzata, sabiex tiġi assigurata evalwazzjoni xierqa tar-riskji u l-benefiċċji.
English: Studies in healthy volunteers and parkinsonian patients have confirmed that the maximum effect occurs with 100 - 200 mg tolcapone.
Maltese: Studji fuq voluntiera b'saħħithom u fuq pazjenti jsofru mill-marda ta' Parkinson ikkonfermaw li l-effett massimu jidher b'100 - 200 mg ta' tolcapone.
English: Reducing the dose of levodopa (see section 4.2) may often mitigate these adverse reactions.
Maltese: It-tnaqqis fid-doża ta' levodopa (ara sezzjoni 4.2) spiss jista' jnaqqas dawn ir-reazzjonijiet avversi.
English: In Parkinson`s patients, NMS tends to occur when discontinuing or stopping dopaminergic-enhancing medications.
Maltese: F'pazjenti tal-Parkinsons, hemm tendenza li sseħħ NMS meta mediċini li jtejbu dopaminerġikament, jitnaqqsu jew jitwaqqfu.
English: Tasmar 100 mg (only applicable for the outer carton)
Maltese: Tasmar 100mg (applikabbli biss għall-kartuna ta' barra)
English: Dyskinesia Dystonia Headache Dizziness
Maltese: Diskinesija Distonija Uġigħ ta' ras Sturdament Ħedla ta' ngħas Ilmenti ortostatiċi
English: Very common: involuntary movement (dyskinesia), nausea, decreased appetite, diarrhoea, headache, dizziness sleep problems, somnolence, feeling lightheaded while you stand, (orthostatic complaints), mental confusion and hallucinations, movement disorder with involuntary muscle spasms or malpositions (dystonia).
Maltese: Komuni ħafna: - moviment involontarju (diskinesja), - tqalligħ, tnaqqis fl-aptit, dijarea, - uġigħ ta' ras, sturdament, - problemi fl-irqad, ngħas, - tħossok ħa tistordi waqt li tkun bil-wiefqa, (ilmenti ortostatiċi), - konfużjoni mentali u alluċinazzjonijiet, - disturb fil-moviment bi spażmi involontarji tal-muskoli jew pożizzjonijiet ħżiena (distonja).
English: Furthermore a reduction of levodopa dose or termination of therapy may be considered (see section 4.7).
Maltese: Barra minn dan tnaqqis taddoża ta' levodopa jew terminazzjoni tat-terapija jista' jkun kkunsidrat (ara sezzjoni 4.7).
English: On the other hand, after co-administration of tolcapone and benserazide-50 mg/levodopa the benserazide plasma concentrations could be increased above the levels usually observed with levodopa/benserazide alone.
Maltese: Min-naħa l-oħra, wara l-amministrazzjoni f'daqqa ta' tolcapone u benserazide-50 mg/levodopa il-konċentrazzjonijiet ta' plażma ta' benserazide setgħu jiżdiedu aktar mil-livelli normalment osservati b' levodopa/benserazide waħedhom.
English: Biotransformation/Elimination: Tolcapone is almost completely metabolised prior to excretion, with only a very small amount (0.5 % of dose) found unchanged in urine.
Maltese: Tolcapone jiġi kważi kompletament metabolizzat qabel leskrezzjoni, b'ammont żgħir ħafna biss (0.5% tad-doża) li jibqa' mhux mibdul fl-urina.
English: Very rare (<1/10,000), not known (cannot be estimated from the available data)
Maltese: Rari ħafna (< 1/10,000), mhux magħrufa (ma jistgħux jkunu estimati mill-informazzjoni provduta)
English: Excipients with known effect: Each tablet contains 7.5 mg lactose For the full list of excipients, see section 6.1.
Maltese: Kull pillola fiha 7.5mg lactose Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: EU/1/97/044/001-3, 7, 8, 10
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/044/001-3, 7, 8, 10
English: Upper respiratory tract infection
Maltese: Infezzjoni fil-Parti Respiratorja ta' Fuq
English: A previous history of Neuroleptic Malignant Syndrome (NMS) Symptom Complex and /or non-traumatic Rhabdomyolysis or Hyperthermia.
Maltese: • Passat ta' Kumpless Sintomatiku tas-Sindromu Malinn Newroleptiku (NMS) u/jew
English: Renal and urinary disorders
Maltese: Indeboliment renali:
English: Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders.
Maltese: Il-pazjenti għandhom jiġu ssorveljati b'mod regolari għall-iżvilupp ta' disturbi fil-kontroll tal-impuls.
English: The plasma concentrations of benserazide observed after co-administration of tolcapone and benserazide-25 mg/levodopa were still within the range of values observed with levodopa/benserazide alone.
Maltese: Il-konċentrazzjonijiet ta' plażma ta' benserazide osservati wara lamministrazzjoni f'daqqa ta'tolcapone u benserazide-25 mg/levodopa xorta waħda kienu fil-medda ta' valuri osservati b'levodopa/benserazide waħdu.
English: While receiving treatment: During treatment, blood tests will be done in the following time intervals: every 2 weeks during the first 12 months of therapy, every 4 weeks during the following 6 months of therapy, every 8 weeks during further treatment.
Maltese: Waqt il-kura, testijiet tad-demm se jsiru fl-intervlli ta' żmien li ġejjin: - kull ġimagħtejn waqt l-ewwel 12-il xahar ta' terapija, - kull 4 ġimgħat waqt is-6 xhur ta' terapija ta' wara, - kull 8 ġimgħat waqt aktar kura.
English: Tasmar is indicated in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-o-methyltransferase (COMT) inhibitors (see section 5.1).
Maltese: Tasmar jiġi indikat flimkien ma' levodopa/benserazide jew levodopa/carbidopa għall-użu f'pazjenti bil-marda Parkinson idjopatika u li tirrispondi għal-levodopa u b'varjazzjonijiet tal-movimenti, li ma jittollerawx jew li naqsu milli jirrispondu għal inibituri catechol-O-methyltransferase (COMT) oħrajn (ara sezzjoni 5.1).
English: Neuroleptic Malignant Syndrome Symptom Complex (see section 4.4)
Maltese: Kumpless ta' Sintomi tasSindrome Newrolettiku Malinn (ara sezzjoni 4.4)
English: It is available in blisters in pack sizes of 30 and 60 tablets and in glass bottles in pack sizes of 100 tablets.
Maltese: Huwa disponibbli f'folji f'pakketti ta' 30 u 60 pillola u fi flixkien tal-ħġieġ f'pakketti ta' 100 pillola.
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 Tasmar in association with Levedopa (see section 4.4 `special warnings and precautions for use´).
Maltese: Disturbi fil-kontroll tal-impuls: Logħob tal-azzard patoloġiku, żjieda fil-libido, ipersesswalità, xiri jew bejgħ koerċittiv, teħid ta' ammonti kbar ta' ikel b'mod frekwenti u teħid ta' ikel b'mod koerċittiv jistgħu jseħħu f'pazjenti kkurati b'agonisti ta' dopamine u/jew kura dopaminerġika oħra bħal Tasmar f'assoċjazzjoni ma' levodopa (ara sezzjoni 4.4 “Twissijiet speċjali u prekawzjonijiet għall-użu”).
English: Please inform your doctor about all other medicines you are taking especially: antidepressants, alpha-methyldopa (used to treat increased blood pressure), apomorphine (used for Parkinson's disease), dobutamine (used for the chronic heart disease), adrenaline and isoprenaline (both used for heart attacks), anticoagulants of the warfarin type (that prevent blood clotting).
Maltese: Jekk jogħġbok għarraf lit-tabib tiegħek b'kull mediċina oħra li qiegħed tieħu speċjalment: - antidipressanti, - alpha-methyldopa (użata għall pressjoni għolja), - apomorphine (użata għall-marda ta' Parkinson), - dobutamine (użata fil-kontroll tal-ħsara konġestiva fil-qalb), - adrenalina u isoprenaline (it-tnejn użati għall-attakki tal-qalb), - sustanzi kontra il-koagulazzjoni tad-demm tat-tip ta' warfarin (li jipprevjenu t-tgħaqid taddemm).
English: This leaflet was last revised in:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq:
English: Drugs that increase catecholamines: Since tolcapone interferes with the metabolism of catecholamines, interactions with other drugs affecting catecholamine levels are theoretically possible.
Maltese: Minħabba li tolcapone jinterferi mal-metaboliżmu tal-katekolamini, interazzjoni ma' mediċini oħra li jaffetwaw il-livelli ta' katekolamina huwa teoretikament possibbli.
English: Rarely, after abruptly reducing or stopping Tasmar or other antiparkinsonian drugs, you may experience severe symptoms of muscle stiffening, fever or mental confusion.
Maltese: Rari ħafna, wara li Tasmar jew mediċini oħrajn kontra l-marda ta' Parkinson jitnaqqsu f'daqqa jew jitwaqqfu, jista' jkollok esperjenza ta' sintomi severi ta' ebusija tal-muskoli, deni jew konfużjoni mentali.
English: The effect of tolcapone on the pharmacokinetics of other drugs metabolised by COMT such as -methyldopa, dobutamine, apomorphine, adrenaline and isoprenaline have not been evaluated.
Maltese: L-effett ta' tolcapone fuq il-farmakokinetiċi ta' mediċini oħrajn metabolizzati bil-COMT bħall- -methyldopa, dobutamina, apomorphine, adrenalina u isoprenaline ma' ġiex evalwat.
English: Isolated cases consistent with NMS have been associated with Tasmar treatment.
Maltese: Każi iżolati li huma konsistenti ma' NMS kienu assoċjati ma' trattament ta' Tasmar.
English: CLINICAL PARTICULARS
Maltese: Inibituri selettivi
English: Effect of tolcapone on the metabolism of other drugs: Due to its affinity for cytochrome CYP2C9 in vitro, tolcapone may interfere with drugs whose clearance is dependent on this metabolic pathway, such as tolbutamide and warfarin.
Maltese: L-effett ta' tolcapone fuq il-metaboliżmu ta' mediċini oħrajn: Minħabba l-affinità tiegħu maċċitokromju CYP2C9 in vitro, tolcapone jista' jinterferi ma' mediċini li t-tneħħija tagħhom tiddependi fuq dan il-passaġġ metaboliku, bħal tolbutamide u warfarina.
English: Each film-coated tablet contains 100 mg tolcapone.
Maltese: Kull pillola miksija b'rita fiha 100 mg tolcapone.
English: However, in patients with moderate cirrhotic liver disease, clearance of unbound tolcapone was reduced by almost 50 %.
Maltese: Madanakollu, f'pazjenti b'marda tal-fwied ċirrotika moderata, it-tneħħija ta' tolcapone mhux marbut kienet imnaqqsa bi kważi 50 %.
English: Before starting treatment: To reduce the risk of NMS, Tasmar should not be prescribed for patients with severe dyskinesia or a previous history of NMS including rhabdomyolysis or hyperthermia (see section 4.3).
Maltese: Sabiex jitnaqqas ir-riskju ta' NMS, Tasmar m'għandux jiġi preskritt għal pazjenti b'diskinesija severa jew b'passat ta' NMS inkluża rhabdomyolysis jew ipertermija (ara sezzjoni 4.3).
English: Strong impulse to gamble excessively despite serious personal or family consequences.
Maltese: o Impuls qawwi li tilgħab logħob tal-azzard b'mod eċċessiv minkejja konsegwenzi personali jew familjari serji.
English: Hepatobiliary disorders
Maltese: Indeboliment epatiku:
English: The main metabolic pathway of tolcapone is conjugation to its inactive glucuronide.
Maltese: Il-mod metaboliku prinċipali ta' tolcapone huwa l-konjugazzjoni ma' l-glukuronid inattiv tiegħu.
English: Renal impairment: The pharmacokinetics of tolcapone have not been investigated in patients with renal impairment.
Maltese: Il-farmakokinetiċi ta'tolcapone għadhom ma ġewx investigati f'pazjenti b'indeboliment renali.