natgillin/translations-raw huggingface dataset:
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(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged zaužije peroralno.
Tolcapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catechol-O-methyl transferase (COMT).
Tolkapon blokira encim, ki sodeluje pri razgradnji levodope v telesu in se imenuje katehol- O- metiltransferaza (COMT).
This helps to improve the signs and symptoms of Parkinson’ s disease, such as stiffness and slowness of movement.
To pripomore k izboljšanju znakov in simptomov Parkinsonove bolezni, kot sta okorelost in upočasnjeno izvajanje gibov.
Tasmar was originally studied in a total of 594 patients, in two 13-week studies and one six-week study.
Zdravilo Tasmar so prvotno preučili pri skupno 594 bolnikih v dveh 13- tedenskih študijah in eni šesttedenski študiji.
All of the studies compared the effectiveness of adding Tasmar with that of adding placebo (a dummy treatment) to the patient ’ s existing medication (levodopa and either carbidopa or benserazide).
V vseh študijah so učinkovitost dodajanja zdravila Tasmar primerjali z učinkovitostjo dodajanja placeba (zdravila brez zdravilne učinkovine) k zdravilom, ki jih je bolnik že jemal dotlej (levodopa bodisi skupaj s karbidopo ali z benserazidom).
The main measure of effectiveness was the time spent in the ‘ off’ or in the ‘ on’ state (the time when levodopa is not [off] or is [on] controlling the symptoms of Parkinson’ s disease).
Glavno merilo učinkovitosti je bil čas, ki so ga bolniki preživeli v “ izklopljenem ” ali v “ vklopljenem ” stanju (čas, ko levodopa ne more [izklopljeno] ali lahko [vklopljeno] nadzoruje simptome Parkinsonove bolezni).
Tasmar has been further studied in a ‘ switch’ study in 150 patients.
Zdravilo Tasmar je bilo nadalje raziskano v študiji “ prehoda ” pri 150 bolnikih.
These patients were already receiving a combination of levodopa and entacapone (another medicine that blocks COMT).
Ti bolniki so že prejemali kombinacijo levodope in entakapona (drugega zdravila, ki blokira encim COMT).
The study compared the effectiveness of continuing with entacapone or switching to Tasmar.
V tej študiji so učinkovitost nadaljevanja zdravljenja z entakaponom primerjali s prehodom na zdravljenje z zdravilom Tasmar.
The main measure of effectiveness was the proportion of patients with an increase in ‘ on ’ time of one hour or more, over the three weeks following the switch.
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih se je v časovnem obdobju treh tednov po prehodu na novo zdravilo “ vklopljeno ” stanje podaljšalo za eno uro ali več.
The initial studies showed that Tasmar was more effective than placebo.
Začetne študije so pokazale, da je zdravilo Tasmar učinkovitejše od placeba.
There was a reduction of about 20 to 30% in ‘ off ’ time in patients taking Tasmar.
Pri bolnikih, ki so jemali zdravilo Tasmar, se je čas, ki so ga preživeli v “ izklopljenem ” stanju, skrajšal za približno 20– 30%.
In the switch study, there were more patients who responded to treatment with Tasmar (53%) than to treatment with entacapone (43%).
V študiji “ prehoda ” se je na zdravljenje z zdravilom Tasmar odzvalo več bolnikov (53%) kot pri zdravljenju z entakaponom (43%).
The most common side effects with Tasmar (seen in more than 1 patient in 10) are nausea (feeling sick), anorexia (loss of appetite), diarrhoea, dyskinesia (uncontrollable movements), dystonia (muscle spasms), headache, dizziness, sleep disorders, excessive dreaming, somnolence (sleepiness), confusion, hallucination (seeing things that are not there) and orthostatic complaints (dizziness on standing).
Najpogostejši neželeni učinki zdravila Tasmar (opaženi pri več kot 1 izmed 10 bolnikov) so navzeja (slabost), anoreksija (izguba teka), diareja, diskinezija (nenadzorovani gibi), distonija (mišični krči), glavobol, omotica, spalne motnje, prekomerne sanje, somnolenca (zaspanost), zmedenost, halucinacije (bolnik vidi stvari, ki jih ni) in ortostatične motnje (vrtoglavica v stoječem položaju).
Tasmar can cause liver injury, which can rarely be fatal, and doctors should monitor patients very carefully during treatment.
Zdravilo Tasmar lahko povzroči poškodbe jeter, ki so lahko v redkih primerih usodne, tako da morajo zdravniki med zdravljenjem bolnike pozorno spremljati.
For the full list of all side effects reported with Tasmar, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tasmar, glejte Navodilo za uporabo.
Tasmar should not be used in patients who may be hypersensitive (allergic) to tolcapone or any of the other ingredients.
Zdravila Tasmar ne smejo uporabljati bolniki, ki utegnejo biti preobčutljivi za (alergični na) tolkapon ali katerokoli drugo sestavino zdravila.
It should not be used in patients with: • signs of liver disease or increased liver enzymes, • phaeochromocytoma (a tumour of the adrenal gland), • a history of neuroleptic malignant syndrome (a dangerous nervous disorder usually caused by antipsychotic medicines), rhabdomyolysis (breakdown of muscle fibres) or hyperthermia (heat stroke), • severe dyskinesia.
Zdravilo se ne sme uporabljati pri bolnikih z: • znaki jetrne bolezni ali povišano ravnjo jetrnih encimov, • feokromocitomom (tumorjem nadledvične žleze), • anamnezo malignega neuroleptičnega sindroma (nevarno boleznijo živčnega sistema, ki jo navadno povzročijo antipsihotična zdravila), rabdomiolize (razpadanja mišičnih vlaken) ali hipertermije (vročinskega udara), • hudo diskinezijo.
The Committee for Medicinal products for Human Use (CHMP) decided that Tasmar’ s benefits are greater than its risks 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 COMT inhibitors.
Odbor za zdravila za uporabo v humani medicini (CHMP) je mnenja, da so koristni učinki zdravila Tasmar v kombinaciji z levodopo/ benserazidom ali levodopo/ karbidopo za uporabo pri bolnikih z idiopatsko Parkinsonovo boleznijo, odzivno na levodopo, in motoričnimi fluktuacijami, ki se niso odzvali na druge zaviralce encima COMT ali pa jih ne prenašajo, večji od z njim povezanih tveganj.
The Committee recommended that Tasmar be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Tasmar.
Other information about Tasmar:
Druge informacije o zdravilu Tasmar:
Because of reports of fatal liver injury, the marketing authorisation was suspended on 11 December 1998.
Zaradi poročil o usodnih poškodbah jeter je bilo dovoljenje za promet z zdravilom dne 11. decembra 1998 začasno preklicano.
The suspension was lifted on 31 August 2004.
Preklic je bil umaknjen dne 31. avgusta 2004.
The marketing authorisation holder is Valeant Pharmaceuticals Ltd.
Imetnik dovoljenja za promet z zdravilom je družba Valeant Pharmaceuticals Ltd.
The full EPAR for Tasmar is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tasmar je na voljo tukaj.
Invented name Tasmar Tasmar Tasmar Tasmar Tasmar Tasmar Tasmar Tasmar
Tasmar Tasmar Tasmar Tasmar Tasmar Tasmar Tasmar Tasmar
Strength 100 mg 100 mg 100 mg 200 mg 200 mg 200 mg 100 mg 100 mg
100 mg 100 mg 100 mg 200 mg 200 mg 200 mg 100 mg 100 mg
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
Packaging blister (PVC/ PE/ PVDC) blister (PVC/ PE/ PVDC) bottle (glass) blister (PVC/ PE/ PVDC) blister (PVC/ PE/ PVDC) bottle (glass) bottle (glass) bottle (glass)
pretisni omot (PVC/ PE/ PVDC) pretisni omot (PVC/ PE/ PVDC) stekleničkah pretisni omot (PVC/ PE/ PVDC) pretisni omot (PVC/ PE/ PVDC) stekleničkah stekleničkah stekleničkah
Tasmar 100 mg film-coated tablets.
Tasmar 100 mg filmsko obložena tableta
For excipients, see section 6.1
Za pomožne snovi glejte poglavje 6. 1.
Tasmar 100 mg is a pale to light yellow, hexagonal, biconvex, film-coated tablet. “ TASMAR” and “ 100” are engraved on one side.
Na eni strani tablete je vgravirano “ TASMAR ” in “ 100 ”.
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.
Ker se zdravilo Tasmar uporablja zgolj v kombinaciji z levodopo/ benserazidom in levodopo/ karbidopo, so navodila za predpisovanje omenjenih pripravkov z levodopo uporabna tudi za sočasno zdravljenje z zdravilom Tasmar.
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 COMT inhibitors (see 5.1).
Zdravilo Tasmar se uporablja v kombinaciji z levodopo/ benserazidom ali levodopo/ karbidopo pri bolnikih z na levodopo odzivno idiopatsko Parkinsonovo boleznijo in motoričnimi fluktuacijami, ki se niso odzvali na ostale zaviralce katehol- O- metiltransferaze (COMT), ali pa jih ne prenašajo (glejte 5. 1).
Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa/ benserazide or levodopa/ carbidopa (see 4.4 and 4.8).
Zaradi tveganja za nastanek potencialno smrtne, akutne poškodbe jeter, zdravila Tasmar ne uporabljamo za dodatno zdravljenje prve izbire pri terapiji z levodopo/ benserazidom ali levodopo/ karbidopo (glejte 4. 4 in 4. 8).
If substantial clinical benefits are not seen within 3 weeks of the initiation of the treatment, Tasmar should be discontinued.
Če v treh tednih po začetku zdravljenja z zdravilom Tasmar ne opazimo bistvenih kliničnih koristi, je treba zdravljenje z zdravilom Tasmar prekiniti.
The administration of Tasmar is restricted to prescription and supervision by physicians experienced in the management of advanced Parkinson's disease.
Zdravilo Tasmar lahko predpišejo in zdravljenje spremljajo le zdravniki, izkušeni v zdravljenju napredovale Parkinsonove bolezni.
Posology The recommended dose of Tasmar is 100 mg three times daily, always as an adjunct to levodopa/ benserazide or levodopa/ carbidopa therapy.
Odmerjanje Priporočeni odmerek zdravila Tasmar je 100 mg trikrat na dan, vedno kot dodatek zdravljenja z levodopo/ benserazidom ali levodopo/ karbidopo.
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.
Samo v izjemnih primerih, ko pričakovane zvečane klinične koristi upravičujejo povečano tveganje za jetrne poškodbe, naj se odmerek poveča na 200 mg trikrat na dan (glejte 4. 4 in 4. 8).
If the dose is increased to 200 mg tid, liver enzyme monitoring should take place before increasing the dose and then be reinitiated following the same sequence of frequencies as above (See 4.4 and 4.8).
Če odmerek povečamo na 200 mg trikrat na dan, moramo pred tem kontrolirati jetrne encime in spremljanje nadaljevati z enako pogostnostjo, kot je navedeno zgoraj (glejte 4. 4 in 4. 8).
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 4.4).
Zdravljenje z zdravilom Tasmar moramo prav tako prekiniti, če vrednosti ALT (alanin - aminotransferaza) in/ ali AST (aspartat- aminotransferaza) presežejo zgornje referenčne vrednosti, ali če simptomi ali znaki kažejo na začetek jetrne okvare (glejte 4. 4)
As Tasmar decreases the breakdown of levodopa in the body, side effects due to increased levodopa concentrations may occur when beginning Tasmar treatment.
2 Prilagajanje odmerka levodope med zdravljenjem z zdravilom Tasmar Ker zdravilo Tasmar zmanjša razgradnjo levodope v telesu, se lahko ob začetku zdravljenja z zdravilom Tasmar zaradi zvišanih koncentracij levodope pojavijo neželeni učinki.
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.
V kliničnih preskušanjih je več kot 70% bolnikov potrebovala zmanjšanje dnevnega odmerka levodope, če so jemali več kot 600 mg levodope na dan ali pa so pred začetkom zdravljenja imeli zmerno ali hudo diskinezijo.
The average reduction in daily levodopa dose was about 30% in those patients requiring a levodopa dose reduction.
Bolnikom, ki so potrebovali zmanjšanje odmerka, so dnevne odmerke levodope v povprečju zmanjšali za okoli 30%.
When beginning Tasmar, all patients should be informed of the symptoms of excessive levodopa dosage and what to do if it occurs.
Vse bolnike je ob začetku zdravljenja z zdravilom Tasmar treba seznaniti s simptomi presežka levodope in potrebnimi ukrepi, če do tega pride.
However, when Tasmar therapy is being discontinued for reasons other than too much levodopa, levodopa dosage 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.
Kadar pa terapijo z zdravilom Tasmar prekinemo zaradi razlogov, drugačnih kot je presežek levodope, bo odmerek levodope verjetno treba zvečati na enak ali večji kot pred uvedbo terapije z zdravilom Tasmar, še posebno, če so bolniku odmerek levodope po uvedbi zdravila Tasmar močno zmanjšali.
In all cases, patients should be educated on the symptoms of levodopa underdosage and what to do if it occurs.
V vseh primerih je treba bolnike poučiti o simptomih pomanjkanja levodope in ukrepih ob njegovem morebitnem pojavu.
No dose adjustment of Tasmar is recommended for patients with mild or moderate renal impairment (creatinine clearance of 30 ml/ min or greater).
Bolniki z okvarjeno ledvično funkcijo (glejte 5. 2): bolnikom z blažjo ali zmerno okvaro ledvične funkcije (kreatininski očistek 30 ml/ min ali več) ni treba prilagajati odmerkov zdravila Tasmar.
Tasmar is contraindicated for patients with liver disease or increased liver enzymes.
Bolniki z jetrno okvaro (glejte 4. 3): zdravilo Tasmar je kontraindicirano pri bolnikih z jetrno boleznijo ali povišanimi jetrnimi encimi.
No dose adjustment of Tasmar is recommended for elderly patients.
Starejši bolniki: odmerkov zdravila Tasmar pri starejših bolnikih ni treba prilagajati.
Tasmar should not be used in children as there are no data available.
Otroci: zdravila Tasmar pri otrocih ne uporabljamo, saj podatkov ni na voljo.
There is no identified potential use of tolcapone in paediatric patients.
Možne uporabe tolkapona pri otrocih niso ugotovili.
Method of administration Tasmar is administered orally three times daily.
Način uporabe Zdravilo Tasmar se jemlje peroralno trikrat na dan.
The first dose of the day of Tasmar should be taken together with the first dose of the day of a levodopa preparation, and the subsequent doses should be given approximately 6 and 12 hours later.
Prvi dnevni odmerek zdravila Tasmar je treba vzeti skupaj s prvim dnevnim odmerkom pripravka z levodopo, naslednja odmerka pa naj se vzameta približno 6 in 12 ur pozneje.
Tasmar may be taken with or without food (see 5.2).
Zdravilo Tasmar se lahko jemlje s hrano ali brez nje (glejte 5. 2).
Tasmar can be combined with all pharmaceutical formulations of levodopa/ benserazide and levodopa/ carbidopa (see also 4.5).
Zdravilo Tasmar lahko kombiniramo z vsemi farmacevtskimi formulacijami levodope/ benserazida in levodope/ karbidope (glejte 4. 5).
Tasmar is contraindicated in patients with:
Zdravilo Tasmar je kontraindicirano pri bolnikih z:
• Evidence of liver disease or increased liver enzymes • Severe dyskinesia • A previous history of Neuroleptic Malignant Syndrome Symptom Complex (NMS) and / or non- traumatic Rhabdomyolysis or Hyperthermia. • Hypersensitivity to tolcapone or any of its other ingredients. • Phaeochromocytoma.
• znaki jetrne bolezni ali povišanimi jetrnimi encimi, • hudo diskinezijo, • anamnezo malignega nevroleptičnega sindroma s kompleksom simptomov (NMS) in/ ali netravmatsko rabdomiolizo ali hipertermijo, • preobčutljivostjo za tolkapon ali katerokoli pomožno snov, • feokromocitomom.
3 4.4 Special warnings and special precautions for use
3 4. 4 Posebna opozorila in previdnostni ukrepi
Tasmar therapy should only be initiated by physicians experienced in the management of advanced Parkinson’ s disease, to ensure an appropriate risk-benefit assessment.
Zdravljenje z zdravilom Tasmar naj uvedejo le zdravniki, izkušeni v zdravljenju napredovale Parkinsonove bolezni, da je zagotovljena primerna ocena razmerja med tveganjem in koristjo zdravljenja.
Tasmar should not be prescribed until there has been a complete informative discussion of the risks with the patient.
Zdravilo Tasmar se ne sme predpisati, dokler ni popolne poučne obravnave tveganja z bolnikom.
Liver Injury:
Poškodbe jeter
Because of the risk of rare but potentially fatal acute liver injury, Tasmar is only indicated for use in patients with levodopa-responsive idiopathic Parkinson’ s disease and motor fluctuations, who failed to respond to or are intolerant of other COMT inhibitors.
Zaradi tveganja za nastanek redke, a potencialno smrtne akutne poškodbe jeter, je zdravilo Tasmar indicirano le pri bolnikih z na levodopo odzivno idiopatsko Parkinsonovo boleznijo in motoričnimi fluktuacijami, ki niso odgovorili na zdravljenje z ostalimi zaviralci COMT ali jih ne prenašajo.
Periodic monitoring of liver enzymes cannot reliably predict the occurrence of fulminant hepatitis.
S periodičnim spremljanjem jetrnih encimov ne moremo zanesljivo napovedati nastanka fulminantnega hepatitisa.
However, it is generally believed that early detection of medication-induced hepatic injury along with immediate withdrawal of the suspect medication enhances the likelihood for recovery.
Toda, v splošnem smatramo, da zgodnje odkritje z zdravili povzročene jetrne poškodbe skupaj s takojšnjo ukinitvijo osumljenega zdravila, poveča možnost okrevanja.
Liver injury has most often occurred between 1 month and 6 months after starting treatment with Tasmar.
Jetrna poškodba se je največkrat pojavila med 1. in 6. mesecem zdravljenja z zdravilom Tasmar.
Additionally late onset hepatitis after approximately 18 months of treatment has been reported rarely.
Poredkoma se pojavi kasnejša jetrna poškodba po približno 18 mesecih zdravljenja.
It should also be noted that female patients may have a higher risk of liver injury (see 4.8).
Prav tako je treba omeniti, da utegne biti tveganje za jetrne poškodbe večje pri ženskah (glejte 4. 8).
If liver function tests are abnormal or there are signs of impaired liver function, Tasmar should not be prescribed.
Pred začetkom zdravljenja: če jetrni testi niso normalni ali obstajajo znaki jetrne okvare, se zdravila Tasmar ne sme predpisati.
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.
Če zdravilo Tasmar nameravamo predpisati, mora biti bolnik obveščen o znakih in simptomih, ki lahko kažejo na jetrno poškodbo in o tem, da nemudoma obvesti zdravnika.
Liver function should be monitored every 2 weeks for the first year of therapy, every 4 weeks for the next 6 months and every 8 weeks thereafter.
Med zdravljenjem: delovanje jeter je treba kontrolirati vsaka 2 tedna v prvem letu zdravljenja, vsake 4 tedne naslednjih 6 mesecev in vsakih 8 tednov za tem.
If the dose is increased to 200 mg tid, liver enzyme monitoring should take place before increasing the dose and then be re-initiated following the sequence of frequencies as above.
Če odmerek povečamo na 200 mg trikrat na dan, moramo jetrne encime kontrolirati pred tem in nadaljevati z enako pogostnostjo, kot je navedeno zgoraj.
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.
Zdravljenje se mora takoj prekiniti, če vrednosti ALT in/ ali AST presežejo zgornjo referenčno vrednost, ali če se razvijejo simptomi ali znaki, ki kažejo na začetek jetrne okvare (nenehna slabost, utrujenost, letargija, anoreksija, zlatenica, temen urin, pruritus, občutljivost zgornjega desnega kvadranta).
Patients who show evidence of acute liver injury while on Tasmar and are withdrawn from the drug may be at increased risk for liver injury if Tasmar is re- introduced.
Če zdravljenje prekinemo: bolniki, ki med zdravljenjem z zdravilom Tasmar kažejo znake akutne jetrne poškodbe in jim zdravilo ukinemo, so verjetno izpostavljeni večjemu tveganju za poškodbo jeter, če zdravilo Tasmar ponovno uvedemo.
Neuroleptic Malignant Syndrome (NMS):
Maligni nevroleptični sindrom (NMS)
In Parkinson`s patients, NMS tends to occur when discontinuing or stopping dopaminergic- enhancing medications.
Pri bolnikih s Parkinsonovo boleznijo se NMS pojavi predvsem takrat, ko prekinjamo ali ukinjamo dopaminergike.
Therefore, if symptoms occur after discontinuing Tasmar, physicians should consider increasing the patient’ s levodopa dose (see 4.2).
Če se simptomi pojavijo po prekinitvi zdravljenja z zdravilom Tasmar, naj zdravniki razmislijo o zvečanju bolnikovega odmerka levodope (glejte 4. 2).
Isolated cases consistent with NMS have been associated with Tasmar treatment.
Posamezni primeri skladni z NMS so bili povezani z zdravljenjem z zdravilom Tasmar.
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 opredeljen z motoričnimi simptomi (togost, mioklonus in tremor), spremembami v mentalnem statusu (agitacija, zmedenost, stupor in koma), zvišano telesno temperaturo, avtonomno disfunkcijo (nestabilen krvni tlak, tahikardija) in povišano serumsko kreatin - fosfokinazo (CPK), ki je lahko posledica miolize.
A diagnosis of NMS should be considered even if not all the above findings are present.
Tudi brez vseh zgoraj naštetih pojavov je potrebno pretehtati diagnozo NMS.
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
4 Pred začetkom zdravljenja: da bi zmanjšali tveganje za NMS, bolnikom s hudo diskinezijo in anamnezo NMS, vključno z rabdomiolizo ali hipertermijo, zdravila Tasmar ne predpisujemo (glejte 4. 3).
Patients receiving multiple medications with effects on different CNS pathways (e. g. antidepressants, neuroleptics, anticholinergics) may be at greater risk of developing NMS.
Bolniki, ki jemljejo več zdravil z učinki na različne poti v osrednjem živčnem sistemu (npr. antidepresive, nevroleptike, antiholinergike), so verjetno izpostavljeni večjemu tveganju za razvoj NMS.
Patients may experience an increase in levodopa-associated adverse reactions.
Diskinezija, slabost in drugi neželeni učinki, povezani z levodopo: bolniki lahko izkusijo več neželenih učinkov povezanih z levodopo.