natgillin/translations-raw huggingface dataset:
An interaction was observed with benserazide, which may lead to increased levels of benserazide and its active metabolite.
Opažena je interakcija s benzerazidom, koja može voditi do povišenih razina benzerazida i njegovog aktivnog metabolita.
The maximum therapeutic dose of 200 mg three times daily should not be exceeded, as there is no evidence of additional efficacy at higher doses.
Maksimalna terapijska doza od 200 mg tri puta dnevno se ne smije prekoračiti jer ne postoje dokazi o dodatnoj djelotvornosti pri većim dozama.
Liver injury has occurred most often after 1 month and before 6 months.
Oštećenje jetre najčešće se javljalo nakon 1 mjeseca i prije 6 mjeseci.
However, it is generally believed that early detection of medicine-induced hepatic injury along with immediate withdrawal of the suspect medication enhances the likelihood for recovery.
Međutim, općenito se smatra da rano otkrivanje lijekovima izazvanog oštećenja jetre, zajedno s trenutnim ukidanjem suspektnog lijeka, povećava vjerojatnost oporavka.
- Impulse control disorders (inability to resist the impulse of an action that could be harmful).
- poremećaj kontrole impulsa (nemogućnost odupiranja impulse za neki postupak koji može biti štetan)
Tasmar is not recommended for use in children below the age of 18 due to insufficient data on safety or efficacy.
Ne preporučuje se primjena Tasmara u djece mlađe od 18 godina zbog nedostatka podataka o sigurnosti i učinkovitosti.
Do not use Tasmar if you notice that the tablets are damaged.
Tasmar se ne smije primijeniti ako primijetite da su tablete oštećene.
If you go to hospital or if you are prescribed a new medicine, you must tell your doctor that you are taking Tasmar.
Ako odlazite u bolnicu ili Vam je propisan novi lijek, morate reći Vašem liječniku da uzimate Tasmar.
Biotransformation/Elimination: Tolcapone is almost completely metabolised prior to excretion, with only a very small amount (0.5 % of dose) found unchanged in urine.
Biotransformacija/Eliminacija: tolkapon se gotovo potpuno metabolizira prije izlučivanja, a tek se mala količina (0,5 % doze) nađe nepromijenjena u urinu.
Tell your doctor if you experience any of these behaviours; these will discuss ways of managing or reducing the symptoms.
Obavijestite svog liječnika ili ljekarnika ako primijetite bilo koje od ovih ponašanja; oni će razmotriti načine zbrinjavanja ili smanjenja simptoma.
Tasmar may cause rare but potentially fatal liver injury.
Tasmar može prouzročiti rijetko, ali potencijalno smrtonosno oštećenje jetre.
In general, the average peak levodopa plasma concentration (Cmax) and the time of its occurrence (tmax) were unaffected.
Općenito, prosječne vršne koncentracije levodope u plazmi (Cmax) i vrijeme njihove pojave (tmax) bili su nepromijenjeni.
The reduction to a putative amine, as well as the subsequent N-acetylation, occurs to a minor extent.
Redukcija u putativni amin, kao i posljedična N-acetilacija, javlja se u manjem opsegu.
35-959 Rzeszów Poland
35-959 Rzeszów Poljska
Lactose intolerance: Tasmar contains lactose.
Intolerancija laktoze: Tasmar sadrži laktozu.
Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders.
Poremećaji kontrole impulsa: bolesnike treba redovito nadzirati zbog mogućeg razvoja poremećaja kontrole impulsa.
Isolated cases of either accidental or intentional overdose with tolcapone tablets have been reported.
Prijavljeni su izolirani slučajevi slučajnog ili namjernog predoziranja tabletama tolkapona.
There is no relevant indication for use in children and adolescents.
Nema relevantne indikacije za primjenu u djece i adolescenata.
Muscle injury can sometimes cause dark urine.
Oštećenje mišića može ponekad prouzročiti tamnu mokraću.
Tasmar should not be prescribed until there has been a complete informative discussion of the risks with the patient.
Tasmar se ne bi smio propisati prije cjelovitog informativnog razgovora s bolesnikom o rizicima.
Isolated cases consistent with NMS have been associated with Tasmar treatment.
Izolirani slučajevi konzistentni s NMS-om povezivani su s liječenjem Tasmarom.
Studies in healthy volunteers and parkinsonian patients have confirmed that the maximum effect occurs with 100 - 200 mg tolcapone.
Ispitivanja na zdravim dobrovoljcima i bolesnicima s Parkinsonovom bolešću potvrdila su da se maksimalni učinak javlja sa 100-200 mg tolkapona.
The following doses of Tasmar should be taken 6 and 12 hours later.
Sljedeće doze Tasmara trebali biste uzeti 6 i 12 sati kasnije.
It should also be noted that female patients may have a higher risk of liver injury.
Treba također napomenuti da ženski bolesnici imaju veći rizik od oštećenja jetre.
The safety of tolcapone in infants is unknown; therefore, women should not breast-feed during treatment with Tasmar.
Sigurnost tolkapona za dojenčad je nepoznata; stoga, žene ne bi smjele dojiti tijekom liječenja Tasmarom.
In vitro experiments have shown that tolcapone binds mainly to serum albumin.
In vitro pokusi pokazali su da se tolkapon vezuje uglavnom na serumski albumin.
After oral administration, 60 % of drug-related material is excreted into urine and 40 % into faeces.
Nakon peroralne primjene, 60 % tvari povezane s lijekom izlučuje se u urin, a 40 % u feces.
Your doctor will discuss the risks and benefits of taking Tasmar during pregnancy.
Vaš liječnik će razmotriti rizike i dobrobiti uzimanja Tasmara tijekom trudnoće.
This is due to a decrease in clearance in L-dopa resulting in a prolongation of the terminal elimination half-life (t1/2) of levodopa.
To je zbog smanjenja klirensa L-dope što rezultira produljenjem terminalnog poluvijeka eliminacije (t1/2) levodope.
The treatment with Tasmar may sometimes lead to disturbances in the way the liver works.
Liječenje Tasmarom ponekad može dovesti do poremećaja u načinu rada jetre.
The frequency of possible side effects listed below is defined using the following convention:
Učestalost mogućih nuspojava navedenih ispod definirana je koristeći se sljedećom konvencijom: Vrlo često:
if you develop persistent or severe diarrhoea
- ako razvijete dugotrajni ili teški proljev.
With 200 mg tolcapone, maximum inhibition of erythrocyte COMT activity is, on average, greater than 80 %.
S 200 mg tolkapona maksimalna inhibicija aktivnosti eritrocitnog COMT-a je prosječno bila veća od 80 %.
Furthermore a reduction of levodopa dose or termination of therapy may be considered.
Nadalje se može razmotriti smanjenje doze levodope ili prestanak terapije.
Tasmar has an effect on the symptoms of your Parkinson's disease.
Tasmar ima učinke na simptome Parkinsonove bolesti.
The main metabolic pathway of tolcapone is conjugation to its inactive glucuronide.
Glavni metabolički put tolkapona je konjugacija u njegov inaktivni glukuronid.
Before beginning treatment:
Prije početka liječenja:
Based on the physicochemical properties of the compound, hemodialysis is unlikely to be of benefit.
Na temelju fizikalno-kemijskih svojstava spoja, nije vjerojatno da će hemodijaliza biti od koristi.
Therefore, clinically relevant interactions involving cytochrome CYP2C9 appear unlikely.
Stoga se klinički značajne interakcije koje uključuju citokrom CYP2C9 ne čine vjerojatnima.
Do not stop Tasmar or any other Parkinson's medications without telling your doctor as this may increase the risk of NMS.
Nemojte prekidati liječenje Tasmarom ili bilo kojim drugim lijekom za Parkinsonovu bolest, a da to ne kažete svom liječniku, jer to može povećati rizik od NMS-a.
During dosing with Tasmar 200 mg three times daily, erythrocyte COMT inhibition at trough is 30 % to 45 %, with no development of tolerance.
Tijekom doziranja Tasmara od 200 mg tri puta dnevno, inhibicija eritrocitnog COMT-a bila je 30 % do 45 %, bez razvoja tolerancije.
Tell your doctor if you or your family/ carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Obavijestite svog liječnika ako Vi ili Vaša obitelj / njegovatelj primijeti da razvijate nagone ili želje da se ponašate na način koji nije uobičajen za Vas ili ne možete odoljeti impulsima, nagonima ili iskušenjima da izvodite određene aktivnosti koje bi mogle naškoditi Vama ili drugima.
The inhibition is closely related to plasma tolcapone concentration.
Inhibicija je blisko povezana s koncentracijama tolkapona u plazmi.
Tasmar blocks this enzyme and thus slows the breakdown of levodopa.
Tasmar blokira taj enzim te time usporava razgrađivanje levodope.
p value 95 % CI
95 % CI
However, no evidence of renal toxicity was observed in the low-dose group.
Međutim, nisu opaženi dokazi za renalnu toksičnost u skupini koja je primala nisku dozu.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Pretklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne toksičnosti.
Tolcapone markedly reduces the formation of 3-OMD.
Tolkapon značajno smanjuje stvaranje 3-OMD-a.
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 %.
Hrana odgađa i smanjuje apsorpciju tolkapona, ali je relativna bioraspoloživost doze tolkapona uzete s obrokom još uvijek 80 % do 90 %.
The absolute bioavailability of an oral administration is around 65 %.
Apsolutna bioraspoloživost oralne primjene je otprilike 65 %.
Therefore, Tasmar should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Stoga, Tasmar treba primjenjivati tijekom trudnoće samo ako potencijalna korist opravdava potencijalni rizik za fetus.
Furthermore a reduction of levodopa dose or termination of therapy may be considered (see section 4.7).
Nadalje se može razmotriti smanjenje doze levodope ili prestanak terapije (vidjeti dio 4.7).
Do not reduce or stop taking your medicine unless your doctor tells you.
Nemojte smanjivati dozu niti prekidati primjenu lijeka, osim ako Vam to kaže liječnik.
You should not start taking Tasmar until your doctor - has described the risks of treatment with Tasmar, - has explained the measures necessary to minimise those risks, - has answered any questions you may have.
Ne smijete početi uzimati Tasmar ako Vaš liječnik nije - opisao rizike liječenja Tasmarom, - objasnio mjere koje su potrebne da se ti rizici smanje, - odgovorio na sva pitanja koja ste imali.
Diarrhoea associated with Tasmar usually began 2 to 4 months after initiation of therapy.
Proljev povezan s Tasmarom je obično počinjao 2 do 4 mjeseca nakon početka terapije.
There are no adequate data from the use of tolcapone in pregnant women.
Nema odgovarajućih podataka o primjeni tolkapona u trudnica.
It should also be noted that female patients may have a higher risk of liver injury (see section 4.8).
Treba također napomenuti da ženski bolesnici možda imaju veći rizik od oštećenja jetre (vidjeti dio 4.8).
You should only receive Tasmar if your Parkinson's disease is not adequately controlled by the use of other therapies.
Smijete primati Tasmar samo ako Vaša Parkinsonova bolest nije odgovarajuće kontrolirana primjenom drugih terapija.
If you feel unwell, you should contact your doctor because you may need to take less levodopa.
Ako se osjećate loše, obratite se svom liječniku jer možda trebate uzimati manje levodope.
When Tasmar was given together with levodopa/carbidopa and desipramine, there was no significant change in blood pressure, pulse rate and plasma concentrations of desipramine.
Kada se Tasmar davao zajedno s levodopom/karbidopom i desipraminom, nije bilo značajne promjene u krvnom tlaku, brzini pulsa i plazmatskim koncentracijama desipramina.
However, the relationship of renal function and tolcapone pharmacokinetics has been investigated using population pharmacokinetics during clinical trials.
Međutim, povezanost između funkcije bubrega i farmakokinetike tolkapona bila je istražena pomoću populacijske farmakokinetike tijekom kliničkih ispitivanja.
The t1/2 of tolcapone is approximately 2 hours.
Tolkapon ima t1/2 od približno 2 sata.
if you are hypersensitive (allergic) to the active substance tolcapone or to any of the other ingredients of Tasmar.
- ako ste preosjetljivi (alergični) na djelatnu tvar tolkapon ili na bilo koji drugi sastojak Tasmara.
Elderly patients No dose adjustment of Tasmar is recommended for elderly patients.
Nije preporučena prilagodba doze Tasmara za starije bolesnike.
Levodopa has been associated with somnolence and episodes of sudden sleep onset.
Levodopa je povezivana sa somnolencijom i epizodama iznenadnog nastupa sna.
Pharmaco-therapeutic group: Anti-Parkinson drugs, other dopaminergic agents, ATC code: NO4BX01
Farmakoterapijska skupina: antiparkinsonici, ostali dopaminergici, ATK oznaka: NO4BX01
Your doctor should always begin your treatment with the standard dose of 3 times daily 1 tablet (100 mg (1 tablet)).
Vaš liječnik će uvijek početi liječenje standardnom dozom od 1 tablete (100 mg (1 tableta)) 3 puta dnevno.
Swallow Tasmar with 1 glass of water.
Progutajte Tasmar s 1 čašom vode.
Tasmar tablets are film-coated and should be swallowed whole because tolcapone has a bitter taste.
Tasmar tablete su obložene filmom i moraju se progutati cijele jer tolkapon ima gorak okus.
Hepatocellular injury
Hepatocelularno oštećenje
The onset of effect occurs after the first administration.
Nastup učinaka javlja se nakon prve primjene.
Patients receiving multiple medications with effects on different central nervous system (CNS) pathways (e.g. antidepressants, neuroleptics, anticholinergics) may be at greater risk of developing NMS.
Bolesnici koji primaju više lijekova s učincima na različite puteve središnjeg živčanog sustava (SŽS) (npr. antidepresivi, neuroleptici, antikolinergici) mogu imati veći rizik od razvoja NMS-a.
In addition, your doctor will stop Tasmar treatment if after 3 weeks you do not improve enough to justify the risks of continuing treatment.
Nadalje, Vaš će liječnik prekinuti liječenje Tasmarom ako se Vaše stanje nakon 3 tjedna ne poboljša dovoljno značajno da opravda rizike od nastavka liječenja.
Tasmar 100 mg (only applicable for the outer packaging
Tasmar 100 mg (primjenjivo samo na vanjsko pakiranje)
In clinical trials, more than 70 % of patients required a decrease in their daily levodopa dose if their daily dose of levodopa was >600 mg or if patients had moderate or severe dyskinesias before beginning treatment.
U kliničkim ispitivanjima je kod više od 70 % bolesnika bilo potrebno smanjiti njihovu dnevnu dozu levodope, ako im je dnevna doza levodope bila >600 mg ili ako su bolesnici imali umjerene do teške diskinezije prije početka liječenja.
High levels of plasma 3-OMD have been associated with poor response to levodopa in Parkinson's disease patients.
Visoke razine 3-OMD-a u plazmi povezivane su sa slabim odgovorom na levodopu u bolesnika s Parkinsonovom bolešću.
Do not break or crush the tablets.
Nemojte lomiti ili mrviti tablete.
If Tasmar is to be prescribed, the patient should be informed about the signs and symptoms which may indicate liver injury, and to contact the physician immediately.
Ako će se Tasmar propisati, bolesnik treba biti informiran o znakovima i simptomima koji mogu upućivati na oštećenje jetre i odmah se obrati liječniku.
For the remainder, when treatment was discontinued, transaminase levels returned to pre-treatment levels.
Za preostale, kad je liječenje prekinuto, razine transaminaza vratile su se na vrijednosti prije početka liječenja.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa.
Bolesnici moraju biti informirani o tome te im se mora savjetovati da budu oprezni prilikom upravljanja vozilima ili rada na strojevima tijekom liječenja levodopom.
Adverse Events
Štetni događaji
However, if taking the next dose should be directly ahead, do not make up for the forgotten dose.
Međutim, ako bi uzimanje sljedeće doze trebalo slijediti odmah nakon toga, nemojte nadoknađivati propuštenu dozu.
Under such a diagnosis Tasmar should be immediately discontinued and the patient should be followed up closely.
U slučaju takve dijagnoze, Tasmar treba trenutno ukinuti i bolesnika treba pomno nadzirati.
Mutagenesis: Tolcapone was shown not to be genotoxic in a complete series of mutagenicity studies.
Mutageneza: nije se pokazalo da je tolkapon genotoksičan u potpunoj seriji ispitivanja mutagenosti.
Symptoms have usually onset during Tasmar treatment or shortly after Tasmar has been discontinued.
Simptomi obično počnu tijekom liječenja Tasmarom ili kratko nakon ukidanja Tasmara.
Inform your doctor about all prescription and non-prescription medications as the risk of NMS may be increased if you are taking some specific medications.
Obavijestite svog liječnika o svim lijekovima koje uzimate, koje ste dobili na recept ili bez recepta, jer se rizik od NMS-a može povećati ako uzimate neke specifčne lijekove.
Evropská 2590/33C Prague 6 160 00
Česká republika Evropská 2590/33C Prague 6 160 00
To reduce the risk of NMS you should not use Tasmar if your doctor says you have severe involuntary movement (dyskinesia) or a previous illness that may have been NMS.
Radi smanjenja rizika od NMS-a, ne biste smjeli primjenjivati Tasmar ako Vaš liječnik kaže da imate teške nevoljne pokrete (diskineziju) ili prethodnu bolest koja je možda bila NMS.
Only in exceptional circumstances, when the anticipated incremental clinical benefit justifies the increased risk of hepatic reactions, should the dose be increased to 200 mg three times daily (see sections 4.4 and 4.8).
Samo u iznimnim okolnostima, kada očekivana inkrementalna klinička korist opravdava povećani rizik od jetrenih reakcija, doza smije biti povećana na 200 mg tri puta dnevno (vidjeti dijelove 4.4 i 4.8).
Before starting treatment: If liver function tests are abnormal or there are signs of impaired liver function, Tasmar should not be prescribed.
Prije početka liječenja: ako su testovi jetrene funkcije abnormalni ili postoje znakovi oštećene funkcije jetre, Tasmar se ne bi smio propisivati.
The first dose of the day of Tasmar should be taken together the first dose of the day of a levodopa preparation, and the subsequent doses should be given approximately 6 and 12 hours later.
Prva dnevna doza Tasmara treba se uzeti zajedno s prvom dnevnom dozom pripravka levodope, a sljedeće doze treba dati približno 6 i 12 sati kasnije.
Therefore, if symptoms occur after discontinuing Tasmar, physicians should consider increasing the patient's levodopa dose (see section 4.2).
Stoga, ako se simptomi jave nakon prestanka uzimanja Tasmara, liječnici bi trebali razmotriti povećanje bolesnikove doze levodope (vidjeti dio 4.2).
A double-blind trial compared Tasmar with entacapone in Parkinson's disease patients who had at least three hours of OFF time per day while receiving optimised levodopa therapy.
Dvostruko slijepo ispitivanje usporedilo je Tasmar s entakaponom u bolesnika s Parkinsonovom bolešću koji su imali najmanje tri sata dnevno u OFF vremenu dok su primali optimiziranu terapiju levodopom.
In rats and rabbits, embryo-foetal toxicity was observed after tolcapone administration (see section 5.3).
U štakora i kunića opažena je embriofetalna toksičnost nakon primjene tolkapona (vidjeti dio 5.3).
Tasmar is used when all other alternative medicines cannot stabilise your Parkinson's disease.
Tasmar se primjenjuje kada svi drugi lijekovi ne mogu stabilizirati Parkinsonovu bolest.
In addition, the compound is methylated by COMT to 3-O-methyl-tolcapone and metabolised by cytochromes P450 3A4 and P450 2A6 to a primary alcohol (hydroxylation of the methyl group), which is subsequently oxidised to the carboxylic acid.
Nadalje, spoj se metilira COMT-om u 3-O-metil-tolkapon i metabolizira se citokromima P450 3A4 i P450 2A6 u primarni alkohol (hidroksilacija metilne skupine), koji posljedično oksidira u karboksilnu kiselinu.
There were no similar renal findings in the mouse or dogs carcinogenicity studies.
Nije bilo sličnih bubrežnih otkrića u ispitivanjima kancerogenosti na miševima ili psima.
The highest dose of tolcapone administered to humans was 800 mg three times daily, with and without levodopa coadministration, in a one week study in healthy elderly volunteers.
Najviša doza tolkapona primijenjena u ljudi bila je 800 mg tri puta dnevno sa ili bez istodobno primijenjene levodope u jednotjednom ispitivanju na zdravim, starijim dobrovoljcima.
Toxicity to reproduction: Tolcapone, when administered alone, was shown to be neither teratogenic nor to have any relevant effects on fertility.
Reproduktivna toksičnost: pokazalo se da tolkapon, kada se primjenjuje sam, nije teratogen niti ima bilo kakve značajne učinke na plodnost.
Absorption: Tolcapone is rapidly absorbed with a tmax of approximately 2 hours.
Apsorpcija: tolkapon se brzo apsorbira sa tmax od približno 2 sata.
These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings.
Takva ponašanja se nazivaju poremećaji kontrole impulsa te mogu uključivati ovisničko kockanje, prekomjerno jedenje ili trošenje, nenormalno jak seksualni nagon ili preokupaciju s povećanjem seksualnih misli ili osjećaja.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovoga lijeka u promet:
The NMS consists of some or all of the following: severe muscle stiffness, jerking movements of muscles, arms or legs, and soreness of muscles.
NMS se sastoji od nekih ili svih od sljedećih simptoma: - jaka mišićna ukočenost, trzajni pokreti mišića, ruku ili nogu i bol mišića.
You should not breast-feed your infant during treatment with Tasmar.
Ne smijete dojiti dijete tijekom liječenja Tasmarom.
*: Adverse reactions for which no frequency could be derived from clinical studies (i.e. where a specific adverse reaction was not observed in clinical trials but was reported post-marketing only) are indicated by an asterisk (*), and the frequency category has been calculated according to EU Guideline.
: Nuspojave čija se učestalost nije mogla odrediti u kliničkim ispitivanjima (tj. kada specifične nuspojave nisu primjećene tijekom kliničkih ispitivanja već je izviješteno o njima samo nakon stavljanja lijeka u promet) označene su zvjezdicom (*), a kategorija učestalosti izračunana je prema EU smjernicama.
Inform your doctor also: - if you have any illnesses other than Parkinson's disease, - if you are allergic to other medicines, food and dyes, - if soon after beginning and during treatment with Tasmar you have symptoms which may be caused by levodopa such as involuntary movement (dyskinesia) and nausea.
Također obavijestite svog liječnika: - ako imate bilo koju drugu bolest pored Parkinsonove bolesti, - ako ste alergični na druge lijekove, hranu i boje, - ako ubrzo nakon početka te tijekom liječenja Tasmarom imate simptome koje je mogla prouzročiti levodopa, kao što su nevoljni pokreti (diskinezija) i mučnina.
However, a study in Parkinson's patients confirmed that after treatment discontinuation there was no significant change in levodopa pharmacokinetics or in patient response to levodopa compared to pretreatment levels.
Međutim, ispitivanje bolesnika s Parkinsonovom bolešću potvrdilo je da nakon prestanka liječenja nije bilo značajne promjene u farmakokinetici levodope ili u bolesnikovu odgovoru na levodopu, u odnosu na razine prije liječenja.
Liver injury:
Oštećenje jetre:
No dose adjustment of Tasmar is recommended for patients with mild or moderate renal impairment (creatinine clearance of 30 ml/min or greater).
Nije preporučena prilagodba doze Tasmara za bolesnike s blagim ili umjerenim oštećenjem bubrega (klirens kreatinina od 30 ml/min ili veći).