natgillin/translations-raw huggingface dataset:
The average reduction in daily levodopa dose was about 30 % in those patients requiring a levodopa dose reduction.
Prosječno smanjenje dnevne doze levodope bilo je oko 30 % u onih bolesnika kojima je bilo potrebno smanjiti dozu lovodope.
In all cases, patients should be educated on the symptoms of levodopa under-dose and what to do if it occurs.
U svakom slučaju, bolesnici bi trebali biti educirani o simptomima premale doze levodope i što činiti ako do toga dođe.
Tasmar used with your other Parkinson medicines can cause excessive drowsiness (somnolence ) and sudden sleep onset episodes (you may suddenly fall asleep).
Tasmar primijenjen s drugim lijekovima za Parkinsonovu bolest može prouzročiti prekomjernu omamljenost (somnolenciju) i epizode iznenadnog nastupa sna (možete iznenada zaspati).
Tolcapone is an orally active, selective and reversible catechol-O-methyltransferase (COMT) inhibitor.
Tolkapon je oralno aktivni, selektivni i reverzibilni inhibitor katehol-O-metiltransferaze (COMT).
However patients should be advised that their ability to drive and operate machines may be compromised due to their Parkinson's disease symptoms.
Međutim, bolesnike treba upozoriti da njihova sposobnost upravljanja vozilima i rada sa strojevima može biti ugrožena zbog simptoma Parkinsonove bolesti.
No effects were seen on the pharmacokinetics of the COMT substrate carbidopa.
Nisu opaženi učinci na farmakokinetiku COMTovog supstrata karbidope.
In about half the cases, transaminase levels returned spontaneously to baseline values whilst patients continued Tasmar treatment.
U otprilike polovini slučajeva razine transaminaza su se spontano vratile na početne vrijednosti tijekom nastavka bolesnikova liječenja Tasmarom.
Possible side effects Like all medicines, this medicine can have side effects, although not everybody gets them.
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
However, in patients with moderate cirrhotic liver disease, clearance of unbound tolcapone was reduced by almost 50 %.
Međutim, u bolesnika s umjerenom cirotičnom bolešću jetre, klirens nevezanog tolkapona bio je smanjen za gotovo 50 %.
ICN Polfa Rzeszów S.A. ul.
ICN Polfa Rzeszów S.A. ul. Przemysłowa 2
Nausea, vomiting and dizziness were observed, particularly in combination with levodopa.
Opažene su mučnina, povraćanje i omaglica, osobito u kombinaciji s levodopom.
Phaeochromocytoma.
• Feokromocitom.
UNIQUE IDENTIFIER - HUMAN READABLE DATA
18. JEDINSTVENI IDENIFIKATOR- PODACI ČITLJIVI LJUDSKIM OKOM
Tasmar should be discontinued if substantial clinical benefits are not seen within 3 weeks of the initiation of the treatment regardless of dose.
Liječenje Tasmarom treba prekinuti ako se značajne kliničke koristi ne opaze unutar 3 tjedna od početka liječenja, neovisno o dozi.
Rarely, after abruptly reducing or stopping Tasmar or other antiparkinsonian drugs, you may experience severe symptoms of muscle stiffening, fever or mental confusion.
Rijetko, nakon naglog smanjenja ili prestanka liječenja Tasmarom ili drugim antiparkinsonicima, možete iskusiti teške simptome mišićne ukočenosti, vrućicu ili mentalnu smetenost.
In an interaction study, tolcapone did not change the pharmacokinetics of tolbutamide.
U ispitivanju interakcija tolkapon nije promijenio farmakokinetiku tolbutamida.
Do not use after the expiry date stated on the pack.
Ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
Urine discolouration: Tolcapone and its metabolites are yellow and can cause a harmless intensification in the colour of the patient's urine.
Diskoloracija urina: tolkapon i njegovi metaboliti su žuti i mogu prouzročiti neškodljivu intenzivniju boju urina kod bolesnika.
When Tasmar is administered together with levodopa, it increases the relative bioavailability (AUC) of levodopa approximately twofold.
Kada se Tasmar primjenjuje zajedno s levodopom, relativna bioraspoloživost (AUC) levodope povećava se približno dva puta.
The first tablet Tasmar is to be taken in the morning together with your other parkinsonian medicine ‘levodopa'.
Prvu tabletu Tasmara trebate uzeti ujutro zajedno s Vašim drugim lijekom za Parkinsonovu bolest ‘levodopom'.
The combination of MAO-A and MAO-B inhibitors is equivalent to non-selective MAO-inhibition, therefore they should not both be given concomitantly with Tasmar and levodopa preparations (see also section 4.5).
Kombinacija MAO-A i MAO-B inhibitora istovjetna je neselektivnoj MAO-inhibiciji, stoga se oba ne bi smjela davati istodobno s Tasmarom i pripravcima levodope (vidjeti također dio 4.5).
Symptoms of overdose may include nausea, vomiting, dizziness and breathing difficulties.
Simptomi predoziranja mogu uključivati mučninu, povraćanje, omaglicu i otežano disanje.
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).
Karcinogeneza, mutageneza: u ispitivanju kancerogenosti od 24 mjeseca pokazalo se da 3 % i 5 % štakora u skupinama srednjih, odnosno, visokih doza ima bubrežne epitelijalne tumore (adenome ili karcinome).
Number (proportion) with ≥1 hour ON time response 32 (43 %) 40 (53 %) p=0.191 -5.2;26.6 Secondary Outcome
Broj (udio) s odgovorom od ≥ 1 sat u ON vremenu 32 (43 %) 40 (53 %) p=0,191 -5,2;26,6 Sekundarni ishod
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
PODACI KOJE NAJMANJE MORA SADRŽAVATI BLISTER ILI STRIP PAKIRANJE
Soon after beginning and during your treatment with Tasmar, you may have symptoms caused by levodopa such as involuntary movement and nausea.
Ubrzo nakon početka te tijekom liječenja Tasmarom možda ćete imati simptome prouzročene levodopom kao što su nevoljni pokreti i mučnina.
Uncommon: liver injury, in rare cases with fatal outcome
Manje često: oštećenje jetre, u rijetkim slučajevima sa smrtnim ishodom
No studies on the effects of Tasmar on the ability to drive and use machines have been performed.
Nisu provedena ispitivanja učinaka Tasmara na sposobnost upravljanja vozilima i rada sa strojevima.
If you have been already treated with Tasmar and developed acute liver injury during treatment, Tasmar should not be re-introduced again.
Ako ste se već liječili Tasmarom i razvili akutno oštećenje jetre tijekom liječenja, ne biste se smjeli ponovno liječiti Tasmarom.
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).
Zbog rizika od potencijalno smrtonosnog, akutnog oštećenja jetre, Tasmar se ne smije razmatrati kao prva linija adjuvantne terapije levodopi/benzerazidu ili levodopi/karbidopi (vidjeti dijelove 4.4 i 4.8).
Studies in healthy volunteers have shown that tolcapone reversibly inhibits human erythrocyte COMT activity after oral administration.
Ispitivanja na zdravim dobrovoljcima pokazala su da tolkapon reverzibilno inhibira aktivnost COMT-a ljudskih eritrocita nakon peroralne primjene.
General supportive care is indicated.
Indicirana je opća suportivna njega.
During the day 1 film-coated tablet Tasmar Evening
Tijekom dana 1 filmom obložena tableta Tasmar Večer
The effects of Tasmar have not been studied in infants.
Učinci Tasmara nisu ispitivani u dojenčadi.
Selective MAO-B inhibitors should not be used at higher than recommended doses (e.g. selegiline 10 mg/day) when coadministered with Tasmar.
Selektivni MAO-B inhibitori ne smiju se uzimati u dozama većim od preporučenih (npr. selegilin 10 mg/dan) kada se primjenjuju istodobno s Tasmarom.
Tasmar contains lactose
Tasmar sadrži laktozu
Adjustments in levodopa are most likely to be required within 1-2 days of Tasmar discontinuation.
Prilagodbe levodope će najvjerojatnije biti potrebne untar 1-2 dana nakon prekida liječenja Tasmarom.
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.
Učinak tolkapona na farmakokinetiku drugih lijekova metaboliziranih COMTom, kao što su -metildopa, dobutamin, apomorfin, adrenalin i izoprenalin još nije procijenjen.
Benserazide interaction: Due to the interaction between high dose benserazide and tolcapone (resulting in increased levels of benserazide), the prescriber should, until more experience has been gained, be observant of dose-related adverse reactions (see section 4.5).
Interakcija s benzerazidom: zbog interakcije između visokih doza benzerazida i tolkapona (što rezultira povišenim razinama benzerazida), liječnik koji propisuje lijek treba paziti na nuspojave ovisne o dozi dok se ne stekne više iskustva (vidjeti dio 4.5).
Liver injury has most often occurred between 1 month and 6 months after starting treatment with Tasmar.
Oštećenje jetre se najčešće javljalo između 1 mjeseca i 6 mjeseci nakon početka liječenja Tasmarom.
Levodopa dose should not be decreased when Tasmar therapy is being discontinued due to side effects related to too much levodopa.
Dozu levodope se ne bi smjelo smanjiti pri prekidu terapije Tasmarom zbog nuspojava povezanih s previše levodope.
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).
Prije početka liječenja: radi smanjenja rizika od NMS-a, Tasmar ne treba propisivati bolesnicima s teškom diskinezijom ili s prethodnom anamnezom NMS-a, uključujući rabdomiolizu ili hipertermiju (vidjeti dio 4.3).
If you stop taking Tasmar
Ako prestanete uzimati Tasmar
Catechols and other drugs metabolised by catechol-O-methyltransferase (COMT): Tolcapone may influence the pharmacokinetics of drugs metabolised by COMT.
Kateholi i drugi lijekovi metabolizirani katehol-O-metiltransferazom (COMT): tolkapon može utjecati na farmakokinetiku lijekova metaboliziranih COMT-om.
Double blind placebo controlled clinical studies have shown a significant reduction of approximately 20 % to 30 % in OFF time and a similar increase in ON time, accompanied by reduced severity of symptoms in fluctuating patients receiving Tasmar.
Dvostruko slijepa placebom kontrolirana klinička ispitivanja pokazala su značajno smanjenje od otprilike 20 % do 30 % u OFF vremenu te slično povećanje u ON vremenu, popraćeno sa smanjenom težinom simptoma u fluktuirajućim bolesnicima koji su primali Tasmar.
Therefore, if you feel unwell, you should contact your doctor since you may need to have your levodopa dose changed.
Stoga, ako se osjećate loše, trebate se obratiti svom liječniku jer će možda biti potrebno promijeniti Vašu dozu levodope.
Tasmar treatment should also be discontinued if ALT (alanine amino transferase) and/or AST (aspartate amino transferase) exceed the upper limit of normal or symptoms or signs suggest the onset of hepatic failure (see section 4.4).
Liječenje Tasmarom treba prekinuti i ako ALT (alanin aminotransferaza) i/ili AST (aspartat aminotransferaza) premašuju gornju granicu normale ili ako simptomi ili znakovi upućuju na nastup zatajenja jetre (vidjeti dio 4.4).
If substantial clinical benefits are not seen within 3 weeks of the initiation of the treatment (regardless of dose) Tasmar should be discontinued.
Ako se značajna klinička korist ne opazi unutar 3 tjedna od početka liječenja (bez obzira na dozu), Tasmar treba ukinuti.
Do not break or crush tablet.
Nemojte lomiti ili drobiti tabletu.
Experience with Tasmar obtained in parallel placebo-controlled randomised studies in patients with Parkinson's disease is shown in the following table, which lists adverse reactions with a potential relationship to Tasmar.
Iskustvo s Tasmarom dobiveno u paralelnim randomiziranim placebom kontroliranim ispitivanjima u bolesnika s Parkinsonovom bolešću prikazano je u sljedećoj tablici koja navodi nuspojave potencijalno povezane s Tasmarom.
1 film-coated tablet Tasmar Together with the first daily dose ´levodopa'
1 filmom obložena tableta Tasmar Zajedno s prvom dnevnom dozom ´levodope'
If you have forgotten several doses, please inform your doctor and follow the advice given to you.
Ako ste zaboravili nekoliko doza, obavijestite svog liječnika te primijenite savjet koji ste dobili.
Before beginning treatment: To reduce the risk of liver injury you should not use Tasmar if you have a liver disease in case of elevated liver function tests in the blood test done before starting treatment (tests of alanine amino transferase (ALT) and aspartate amino transferase (AST)).
Kako bi se smanjio rizik od oštećenja jetre, ne biste smjeli uzimati Tasmar - ako imate bolest jetre - u slučaju povišenih jetrenih funkcija u krvnom nalazu učinjenom prije početka liječenja (testovi alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST)).
If you do not get better at the higher dose after a total of 3 weeks, your doctor should stop your treatment with Tasmar.
Ako Vam ne bude bolje nakon ukupno 3 tjedna pri većoj dozi, Vaš liječnik bi trebao prekinuti liječenje Tasmarom.
Administered concomitantly with levodopa and an aromatic amino acid decarboxylase inhibitor (AADC-I), it leads to more stable plasma levels of levodopa by reducing metabolism of levodopa to 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD).
Primijenjen istodobno s levodopom i inhibitorom dekarboksilaze aromatske aminokiseline (AADC-I), dovodi do stabilnijih razina levodope u plazmi reducirajući metabolizam levodope na 3-metoksi-4hidroksi-L-fenilalanin (3-OMD).
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.
Učinak tolkapona na metabolizam drugih lijekova: zbog njegova afiniteta za citokrom CYP2C9 in vitro, tolkapon može međudjelovati s lijekovima čiji je klirens ovisan o tom metaboličkom putu, kao što su tolbutamid i varfarin.
Patients being treated with Levodopa and presenting with somnolence and/or sudden sleep episodes must be informed 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 and somnolence have resolved (see also section
Bolesnici koji se liječe levodopom i razviju somnolenciju i/ili epizode iznenadnog sna moraju biti informirani da se suzdržavaju od upravljanja vozilima ili upuštanja u aktivnosti u kojima bi oštećena pozornost mogla predstavljati rizik od ozbiljne ozljede ili smrti za njih ili za druge osobe (npr. rad na strojevima) sve dok takve ponavljajuće epizode i somnolencija ne prestanu (vidjeti također dio 4.4).
There is no evidence from clinical studies that Tasmar adversely influences a patient's ability to drive and use machines.
Nema dokaza iz kliničkih ispitivanja da Tasmar štetno utječe na bolesnikovu sposobnost upravljanja vozilima i rada sa strojevima.
Neuroleptic Malignant Syndrome (NMS):
NMS (neuroleptički maligni sindrom):
Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Bolesnici koji su iskusili somnolenciju i/ili epizodu iznenadnog nastupa sna moraju se suzdržati od upravljanja vozilima ili rada na strojevima.
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.
S druge strane, nakon istodobne primjene tolkapona i benzerazida-50 mg/levodope, koncentracije benzerazida u plazmi mogu se povećati iznad razina uobičajeno opaženih samo s levodopom/benzerazidom.
The recommended dose of Tasmar is 100 mg three times daily, always as an adjunct to levodopa/benserazide or levodopa/carbidopa therapy.
Preporučena doza Tasmara je 100 mg tri puta dnevno, uvijek kao adjuvantna terapija levodopi/benzerazidu ili levodopi/karbidopi.
In animal studies, tolcapone was excreted into maternal milk.
U ispitivanjima na životinjama tolkapon se izlučivao u majčino mlijeko.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU I UNUTRAŠNJEM PAKIRANJU
Patients with hepatic impairment (see section 4.3) Tasmar is contraindicated for patients with liver disease or increased liver enzymes.
Bolesnici s oštećenjem jetre (vidjeti dio 4.3) Tasmar je kontraindiciran u bolesnika s bolešću jetre ili povišenim jetrenim enzimima.
Summary of potentially Tasmar-related adverse reactions, with crude incidence rates for the phase III placebo-controlled studies:
Sažetak nuspojava potencijalno povezanih s Tasmarom s grubim stopama učestalosti iz faze 3 placebom kontroliranih ispitivanja:
Since Tasmar should be used only in combination with levodopa/benserazide and levodopa/carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.
Budući da se Tasmar smije primjenjivati samo u kombinaciji s levodopom/benzerazidom i levodopom/karbidopom, informacije o propisivanju ovih pripravaka levodope su također primjenjive na njihovu istodobnu primjenu s Tasmarom.
Therefore, you should contact your doctor immediately if you experience symptoms such as nausea, vomiting, pain in your stomach (particulary over the liver in the right upper area), loss of appetite, weakness, fever, darkening of urine, jaundice (yellow skin or eyes) or if you tire more easily.
Stoga se trebate odmah obratiti liječniku ako iskusite simptome kao što su mučnina, povraćanje, bol u želucu (osobito kod jetre u gornjem desnom području), gubitak apetita, slabost, vrućica, tamnija mokraća, žutica (žuta koža ili oči) ili ako se lakše umorite.
if you have a special type of tumor in the adrenal medulla (Phaeochromocytoma) - if you take a certain medication to treat depression and anxiety, called non-selective mono amino oxidase (MAO) inhibitors
- ako imate posebnu vrstu tumora u srži nadbubrežne žlijezde (feokromocitom) - ako uzimate određene lijekove za liječenje depresije i tjeskobe, koji se zovu neselektivni inhibitori monoaminooksidaze (MAO).
To improve efficacy, your doctor should only increase the dose to the higher dose (200 mg three times a day) if the increase in how your Parkinson's disease symptoms are controlled outweighs the expected increase in side effects.
Kako bi poboljšao učinkovitost Vaš liječnik smije dozu povećati na veću dozu (200 mg tri puta dnevno), samo ako poboljšanje u kontroliranju simptoma Parkinsonove bolesti nadjačava očekivano pojačanje nuspojava.
NMS is characterised by motor symptoms (rigidity, myoclonus and tremor), mental status changes (agitation, confusion, stupor and coma), elevated temperature, autonomic dysfunction (labile blood pressure, tachycardia) and elevated serum creatine phosphokinase (CPK) which may be a consequence of myolysis.
NMS je karakteriziran motoričkim simptomima (rigidnost, mioklonus i tremor), promjenama mentalnog statusa (agitacija, konfuzija, stupor i koma), povišenom temperaturom, autonomnom disfunkcijom (labilni krvni tlak, tahikardija) i povišenom serumskom kreatin fosfokinazom (engl. creatine phosphokinase, (CPK), koja može biti posljedica miolize.
In clinical trials, patients receiving Tasmar/levodopa preparations reported a similar adverse reaction profile independent of whether or not they were also concomitantly administered selegiline (a MAO-B inhibitor).
U kliničkim ispitivanjima bolesnici koji su primali Tasmar/pripravke levodope prijavili su nuspojave sličnog profila neovisno o tome jesu li ili nisu istodobno uzimali selegilin (MAO-B inhibitor).
The administration of Tasmar is restricted to prescription and supervision by physicians experienced in the management of advanced Parkinson's disease.
Primjena Tasmara ograničena je na propisivanje i nadzor liječnika iskusnih u zbrinjavanju uznapredovale Parkinsonove bolesti.
If you have missed several doses, please inform your doctor and follow the advice given to you
Ako ste propustili nekoliko doza, obavijestite svog liječnika te primijenite savjet koji ste dobili.
However, when Tasmar therapy is being discontinued for reasons other than too much levodopa, levodopa dose may have to be increased to levels equal to or greater than before initiation of Tasmar therapy, especially if the patient had large decreases in levodopa when starting Tasmar.
Međutim, kada se prekida terapija Tasmarom zbog drugih razloga osim previše levodope, doza levodope će se možda morati povećati do razina jednakih ili većih od onih prije početka terapije Tasmarom, osobito ako je bolesnik imao velika smanjenja doze levodope pri početku liječenja Tasmarom.
Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines (see section 4.7).
Bolesnici koji su iskusili somnolenciju i/ili epizodu iznenadnog nastupa sna moraju se suzdržati od upravljanja vozilima ili rada na strojevima (vidjeti dio 4.7).
Hypokinesia Syncope
često hipokinezija sinkopa
Contact your doctor, pharmacist or hospital immediately as you may need urgent medical attention.
Vaš lijek, odmah se obratite liječniku ili bolnici jer će njoj ili njemu možda biti potrebna hitna medicinska pomoć.
When beginning Tasmar, all patients should be informed of the symptoms of excessive levodopa dose and what to do if it occurs.
Kad počinju liječenje Tasmarom svi bi bolesnici morali biti informirani o simptomima prevelike doze levodope te što činiti ako do toga dođe.
Overall, the frequency of adverse reactions increased slightly.
U cjelini, učestalost nuspojava povećala se neznatno.
Tolcapone is a low-extraction-ratio drug (extraction ratio = 0.15), with a moderate systemic clearance of about 7 L/h.
Tolkapon je lijek s niskim omjerom ekstrakcije (omjer ekstrakcije = 0,15), s umjerenim sistemskim klirensom od otprilike 7 l/h.
Drugs that increase catecholamines: Since tolcapone interferes with the metabolism of catecholamines, interactions with other drugs affecting catecholamine levels are theoretically possible.
Lijekovi koji povisuju kateholamine: budući da tolkapon međudjeluje s metabolizmom kateholamina, teoretski su moguće interakcije s drugim lijekovima koji utječu na razine kateholamina.
If you forget to take Tasmar
Ako ste zaboravili uzeti Tasmar
Tasmar therapy should only be initiated by physicians experienced in the management of advanced Parkinson's disease, to ensure an appropriate risk-benefit assessment.
Terapiju Tasmarom trebaju započeti jedino liječnici iskusnici u zbrinjavanju uznapredovale Parkinsonove bolesti, kako bi osigurali odgovarajuću procjenu rizika i koristi.
This could be explained by the fact that only a negligible amount of unchanged tolcapone is excreted in the urine, and the main metabolite, tolcapone-glucuronide, is excreted both in urine and in bile (faeces).
To se može objasniti činjenicom da se samo zanemariva količina nepromijenjenog tolkapona izlučuje u urinu te da se glavni metabolit, tolkapon-glukuronid, izlučuje i putem urina i žuči (feces).
Therefore, caution should be exercised when potent noradrenaline uptake inhibitors such as desipramine, maprotiline, or venlafaxine are administered to Parkinson's disease patients being treated with Tasmar and levodopa preparations.
Stoga treba biti oprezan kada se snažni inhibitori pohrane noradrenalina kao što su desipramin, maprotilin ili venlafaksin daju bolesnicima s Parkinsonovom bolešću koji se liječe Tasmarom i pripravcima levodope.
An increased incidence of uterine adenocarcinomas was seen in the high-dose group of the rat carcinogenicity study.
Opažena je povećana učestalost adenokarcinoma maternice u skupini štakora koja je primala visoke doze u ispitivanja kancerogenosti.
A study in patients with hepatic impairment has shown that moderate non-cirrhotic liver disease had no impact on the pharmacokinetics of tolcapone.
Ispitivanje bolesnika s oštećenjem jetre pokazalo je da umjerena necirotična bolest jetre nema utjecaja na farmakokinetiku tolkapona.