natgillin/translations-raw huggingface dataset:
Som helhed øgedes frekvensen af bivirkninger imidlertid let.
Overall, the frequency of adverse events increased slightly.
Disse bivirkninger var forudsigelige med kendskab til bivirkningerne af hvert af de tre lægemidler.
These adverse events were predictable based on the known adverse reactions to each of the three drugs individually.
Derfor bør der udvises forsigtighed, når potente noradrenalin- uptake - hæmmere som f. eks. desipramin, maprotilin eller venlafaxin administreres til parkinsonpatienter i behandling med Tasmar og levodopapræparater.
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.
I kliniske undersøgelser var den rapporterede bivirkningsprofil næsten den samme for patienter, der behandledes med Tasmar/ levodopa- præparater, uafhængigt af om de også samtidigt fik selegilin (en MAO- B- hæmmer) eller ej.
In clinical trials, patients receiving Tasmar/ levodopa preparations reported a similar adverse event profile independent of whether or not they were also concomitantly administered selegiline (a MAO-B inhibitor).
Der er observeret embryoføtal toksicitet hos rotter og kaniner efter indgift af tolcapon (se 5. 3).
In rats and rabbits, embryo-foetal toxicity was observed after tolcapone administration (see 5.3).
6 Der foreligger ikke tilstrækkelig data om brugen af tolcapon hos gravide kvinder.
There are no adequate data from the use of tolcapone in pregnant women.
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
6 4.7 Effects on ability to drive and use machines
Der er intet fra kliniske undersøgelser som tyder på, at Tasmar har en negativ indflydelse på en patients evne til at føre bil eller betjene maskiner.
There is no evidence from clinical studies that Tasmar adversely influences a patient’ s ability to drive and use machines.
Imidlertid bør patienterne gøres opmærksom på, at deres evne til at føre bil eller betjene maskiner kan være forringet på grund af symptomerne af deres Parkinsons sygdom.
However patients should be advised that their ability to drive and operate machines may be compromised due to their Parkinson’ s disease symptoms.
Tasmar er, som en COMT hæmmer, kendt for at øge biotilgængeligheden af det co- administrerede levodopa.
Tasmar, as a COMT inhibitor, is known to increase the bioavailability of the co-adminstered levodopa.
Den efterfølgende stigning i dopaminerg stimulation kan medføre de dopaminerge bivirkninger, som er observeret efter behandling med COMT- hæmmere.
The consequent increase in dopaminergic stimulation can lead to the dopaminergic side effects observed after treatment with COMT inhibitors.
Dette gælder så længe gentagne episoder og somnolens optræder (se også afsnit 4. 4).
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 4.4)
De mest almindeligt observerede bivirkninger relateret til anvendelsen af Tasmar, som forekommer hyppigere end hos placebobehandlede patienter fremgår af nedenstående tabel.
The most commonly observed adverse events associated with the use of Tasmar, occurring more frequently than in placebo-treated patients are listed in the table below.
Da Tasmar er en COMT- hæmmer, kan det øge biotilgængeligheden af samtidigt administreret levodopa.
However, Tasmar, as a COMT inhibitor, is known to increase the bioavailability of the co-adminstered levodopa.
Den heraf følgende øgning i dopaminerg stimulation kan medføre de dopaminerge bivirkninger, som ses efter behandling med COMT- hæmmere.
The consequent increase in dopaminergic stimulation can lead to the dopaminergic side effects observed after treatment with COMT inhibitors.
De almindeligste af disse bivirkninger er øgede dyskinesier, kvalme, opkastning, abdominalsmerter, besvimelsesanfald, ortostatiske klager, obstipation, søvnforstyrrelser, søvnighed og hallucinationer.
The most common of these are increased dyskinesia, nausea, vomiting, abdominal pain, syncope, orthostatic complains, constipation, sleep disorders, somnolence, hallucination.
Den eneste bivirkning, der ofte medførte seponering af Tasmar i kliniske undersøgelser, var diarré (se 4. 4).
The only adverse event commonly leading to discontinuation of Tasmar in clinical trials was diarrhoea (see 4.4).
Forhøjelser til mere end tre gange den øvre referencegrænse for alaninaminotransferase (ALAT) forekom hos 1% af patienter i behandling med Tasmar 100 mg tre gange daglig og hos 3% af patienter i behandling med 200 mg tre gange daglig.
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.
I ca. halvdelen af tilfældene faldt transaminaseværdierne spontant til udgangsværdierne, medens patienterne fortsat var i Tasmar - behandling.
In about half the cases, transaminase levels returned spontaneously to baseline values whilst patients continued Tasmar treatment.
Efter markedsføringen er der i sjældne tilfælde rapporteret om svær hepato- cellulær skade resulterende i død (se 4. 4).
Rare cases of severe hepatocellular injury resulting in death have been reported during marketed use (see 4.4).
Der er i isolerede tilfælde rapporteret om patienter med symptomer på malignt neuroleptikasyndrom (se 4. 4) efter reduktion eller seponering af Tasmar og efter påbegyndelse af Tasmar efter signifikant reduktion af andre samtidige dopaminerge lægemidler.
Isolated cases of patients with symptoms suggestive of Neuroleptic Malignant Syndrome Symptom Complex (see 4.4) have been reported following reduction or discontinuation of Tasmar and following introduction of Tasmar when this was accompanied by a significant reduction in other concomitant dopaminergic medications.
Misfarvning af urinen:
Urine discolouration:
Tolcapon og dets metabolitter er gule og kan medføre en uskadelig intensivering af farven af patientens urin.
Tolcapone and its metabolites are yellow and can cause a harmless intensification in the colour of the patient’ s urine.
7 Erfaringer med Tasmar fra parallelle, placebo- kontrollerede, randomiserede studier hos patienter med Parkinsons sygdom er vist i den nedenstående tabel, som angiver uønskede virkninger med en potentiel forbindelse med Tasmar.
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.
Resumé af incidensrater for potentielle Tasmarbivirkninger fra fase III placebokontrollerede undersøgelser:
Summary of potentially Tasmar-related adverse reactions, with crude incidence rates for the phase III placebo-controlled studies:
Hyppighed *
Incidence*
Tolcapon Tolcapon tre gange tre gange daglig daglig N=296 N=298 (%) (%)
Tolcapone N=296 (%)
Gastrointestinale sygdomme
Tolcapone N=298 (%)
Meget almindelig
Gastrointestinal disorders Very common Nausea Anorexia Diarrhoea Common Vomiting Constipation Xerostomia
18, 9 22, 8 15, 5 18, 1
17.8 12.8 7.7 3.7 5.0 2.3
Almindelig
30.4 18.9 15.5 8.4 6.4 4.7
Almindelig
34.9 22.8 18.1 9.7 8.4 6.4
Smerter i brystet
Abdominal pain 2.7 Dyspepsia 1.7
3, 4 1, 0
4.7 4.1
Almindelig
5.7 3.0
Infektion i de øvre luftveje
General disorders and administration site conditions
4, 7 7, 4
Common
Meget almindelig
Chest pain 1.3
19, 8
3.4
41, 9 51, 3
1.0
Dystoni Hovedpine Svimmelhed
Infections and infestations
17, 1 7, 4 9, 7
Common
18, 6 22, 1 9, 8 11, 4 13, 2 6, 4
Upper 3.4 respiratory tract infection
Hypokinesi
4.7
0, 7
7.4
0, 7 2, 7
Nervous system disorders Very common Dyskinesia Dystonia Headache Dizziness Common Hypokinesia Psychiatric disorders Very common Sleep disorder Excessive dreaming
Psykiske lidelser
19.8 17.1 7.4 9.7 0.7 18.1 17.1
Meget almindelig
41.9 18.6 9.8 13.2 0.7 23.6 21.3
Søvnløshed
51.3 22.1 11.4 6.4 2.7 24.8 16.4
Drømmer meget Somnolens Konfusion Hallucinationer
Somnolence Confusion Hallucination Renal and urinary Common Urine disorders discoloration
17, 1 13, 4 8, 7 5, 4
13.4 8.7 5.4 0.7
Almindelig
17.9 10.5 8.4 2.4
Misfarvet urin
14.4 10.4 10.4 7.4
Sygdomme i åndedrætsorganer, brysthule og mediastinum
Respiratory, thoracic and Common Influenza mediastinal disorders
Influenza
1.7
1, 7
3.0
3, 0 4, 0
4.0
Sygdomme i hud og subkutane væv
Skin and subcutaneous Common Sweating tissue disorders increased
Meget almindelig
Vascular disorders Very common Orthostatic complaints
13, 8
13.8
Almindelig
Common Syncope
* Meget almindelig (> 1/ 10); almindelig (> 1/ 100, < 1/ 10); usædvanlig (> 1/ 1, 000 < 1/ 100); sjælden (> 1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000)
* Very common (> 1/ 10); common (> 1/ 100< 1/10), uncommon (> 1/1,000 < 1/ 100); rare (1/10,000 < 1/ 1,000); very rare (< 1/10,000)
100 mg og 200 mg tolcapon tre gange daglig).
The peak plasma concentrations of tolcapone at this dose were on average 30 µg/ ml (compared to 3 and 6 µg/ ml with 100 mg tid and 200 mg tid of tolcapone respectively).
Behandling af overdosis:
8 Management of overdose:
Hospitalisering anbefales.
Hospitalisation is advised.
På grund af stoffets fysisk- kemiske egenskaber kan hæmodialyse ikke forventes at være af værdi.
Based on the physicochemical properties of the compound, hemodialysis is unlikely to be of benefit.
Tolcapon er en oral aktiv, selektiv og reversibel catechol- O- methyltransferase (COMT- hæmmer).
Tolcapone is an orally active, selective and reversible catechol-O-methyltransferase (COMT) inhibitor.
Når det administreres samtidig med levodopa og en aromatisk decarboxylasehæmmer (AADC- I) medfører det mere stabile plasmaniveauer af levodopa, idet metaboliseringen af levodopa til 3- methoxy- 4 - hydroxy- l- phenylalanin (3- OMD) reduceres.
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).
Høje 3- OMD- plasmakoncentrationer er sat i forbindelse med dårligt respons på levodopa hos parkinsonpatienter.
High levels of plasma 3-OMD have been associated with poor response to levodopa in Parkinson’ s disease patients.
Tolcapon reducerer dannelsen af 3- OMD betydeligt.
Tolcapone markedly reduces the formation of 3-OMD.
Antiparkinsonmidler, ATC- kode:
Anti-Parkinson drug, ATC code:
Klinisk farmakologi
Clinical pharmacology
Undersøgelse med raske frivillige har vist, at tolcapon reversibelt hæmmer erytrocyt- COMT- aktivitet efter oral administration.
Studies in healthy volunteers have shown that tolcapone reversibly inhibits human erythrocyte COMT activity after oral administration.
Med 200 mg tolcapon er den maksismale hæmning af erytrocyt- COMT- aktiviteten i gennemsnit større end 80%.
With 200 mg tolcapone, maximum inhibition of erythrocyte COMT activity is, on average, greater than 80%.
Ved anvendelse af 200 mg tolcapon tre gange daglig er erytrocyt- COMT- hæmningen ved laveste niveau 30% til 45%, uden udvikling af tolerance.
During dosing with Tasmar 200 mg three times daily, erythrocyte COMT inhibition at trough is 30% to 45%, with no development of tolerance.
Der er set forbigående forhøjelse af erytrocyt- COMT- aktivitet til over præ- behandlingsniveauer efter seponering af tolcapon.
Transient elevation above pretreatment levels of erythrocyte COMT activity was observed after withdrawal of tolcapone.
En undersøgelse af parkinsonpatienter bekræftede imidlertid, at der efter seponering af behandlingen ikke forekom nogen signifikant ændring af levodopas farmakokinetik eller af patientens respons på levodopa sammenlignet med niveauerne før behandlingen.
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.
Dette skyldes en nedsættelse af clearance af L- dopa, som medfører en forlængelse af levodopas terminale eliminationshalveringstid (t½).
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.
Undersøgelser på raske frivillige og på parkinsonpatienter har bekræftet, at den maksimale effekt forekommer efter 100- 200 mg tolcapon.
Studies in healthy volunteers and parkinsonian patients have confirmed that the maximum effect occurs with 100 – 200 mg tolcapone.
Plasmaniveuaet af 3- OMD blev klart og dosisafhængigt nedsat af tolcapon, når det blev indgivet med levodopa/ AADC- I (aromatisk decarboxylasehæmmer) (benserazid eller carbidopa).
Plasma levels of 3- OMD were markedly and dose-dependently decreased by tolcapone when given with levodopa/ AADC-I (aromatic amino acid decarboxylase - inhibitor) (benserazide or carbidopa).
Tolcapons effekt på levodopas farmakokinetik er den samme med alle lægemiddelformer af levodopa/ benserazid og levodopa/ carbidopa; den er uafhængig af levodopadosis, forholdet mellem levodopa og AADC- I (benserazid eller carbidopa) og anvendelse af depotformuleringer.
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.
9 Kliniske undersøgelser
Clinical studies
20% til 30% i OFF- tid og en tilsvarende forlængelse af ON- tid efterfulgt af nedsat symptomsværhedsgrad hos fluktuerende patienter, der fik Tasmar.
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.
Forskernes globale vurderinger af effekt viste også signifikant forbedring.
Investigator’ s global assessments of efficacy also showed significant improvement.
Et dobbelt- blindet studie sammenlignede Tasmar med entakapon hos patienter med Parkinsons sygdom, som havde mindst 3 timers OFF- time pr. dag, mens de fik optimeret behandling med levodopa.
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.
Det primære resultat var procentdelen af patienter med en stigning i ON- tiden på 1 eller flere timer (se tabel 1).
The primary outcome was the proportion of patients with a 1 or more hour increase in ON time (see Table 1).
Tab.
9 Tab.
1 Primær og sekundær resultat af dobbelt- blindet studie Primært resultat
1 Primary and Secondary Outcome of double-blind Trial Primary Outcome
Tolcapon N=75
Tolcapon e N=75
95% konfidens - interval
95% CI
Antallet (procentdelen) med ≥1 times ON- tid respons Sekundært resultat Antallet (procentdelen) med
Number (proportion) with ≥ 1 hour ON time response Secondary Outcome
moderat eller markant forbedring
Number (proportion) with moderate or marked improvement
Indenfor det terapeutiske område er tolcapons farmakokinetik lineær og uafhængig af samtidig administration af levodopa/ AADC- I (benserazid eller carbidopa).
In the therapeutic range, tolcapone pharmacokinetics are linear and independent of levodopa/ AADC-I (benserazide or carbidopa) coadministration.
Absorbtion:
Absorption:
2 timer.
Tolcapone is rapidly absorbed with a tmax of approximately 2 hours.
65%.
The absolute bioavailability of an oral administration is around 65%.
6 µg/ ml.
At these doses, Cmax is approximately 3 and 6 µg/ ml, respectively.
Mad forsinker og nedsætter absorbtionen af tolcapon, men den relative biotilgængelighed af en dosis tolcapon indtaget sammen med mad er stadig 80% til 90%.
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%.
Tolcapons distributionsvolumen (Vss) er lille (9 l).
The volume of distribution (Vss) of tolcapone is small (9 l).
Tolcapon er ikke vidt fordelt i vævene på grund af sin høje plasmaproteinbinding (> 99, 9%).
Tolcapone does not distribute widely into tissues due to its high plasma protein binding (> 99.9%).
In vitro forsøg har vist, at tolcapon hovedsageligt bindes til serum- albumin.
In vitro experiments have shown that tolcapone binds mainly to serum albumin.
Metabolisme/ elimination:
Metabolism/ Elimination:
Tolcapon metaboliseres næsten fuldstændigt før udskillelse og kun en mindre del (0, 5% af dosis) genfindes uomdannet i urinen.
Tolcapone is almost completely metabolised prior to excretion, with only a very small amount (0.5% of dose) found unchanged in urine.
Derudover methyleres stoffet af COMT til 3- O- methyltolcapon og metaboliseres af cytochrom P450 3A4 og P450 2A6 til en primær alkohol (hydroxylering af methylgruppen), som derefter oxideres til carboxylsyren.
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.
I mindre udstrækning forekommer reduktion, formentlig til en amin, og efterfølgende N- acetylering.
The reduction to a putative amine, as well as the subsequent N-acetylation, occurs to a minor extent.
Efter oral indgift udskilles 60% af lægemiddelrelateret substans i urinen og 40% i fæces.
After oral administration, 60% of drug-related material is excreted into urine and 40% into faeces.
Tolcapon er et low- extraction- ratio lægemiddel (ekstraktionsratio = 0, 15) med en moderat systemisk clearance på ca.
Tolcapone is a low-extraction-ratio drug (extraction ratio = 0.15), with a moderate systemic clearance of about 7 L/ h.
2 timer.
The t1/ 2 of tolcapone is approximately 2 hours.
På grund af risikoen for leverskade, som er observeret under anvendelse efter markedsføringen, er Tasmar kontraindiceret til patienter med leversygdom eller forhøjede leverenzymer.
Because of the risk of liver injury observed during post-marketing use, Tasmar is contraindicated in patients with liver disease or increased liver enzymes.
Hos patienter med moderat
A study in patients with hepatic impairment has shown that moderate non-cirrhotic liver disease had no impact on the pharmacokinetics of tolcapone.
10 cirrhotisk leverlidelse reduceredes clearance af ubundet tolcapon imidlertid med næsten 50%.
However, in patients with moderate cirrhotic liver disease, clearance of unbound tolcapone was reduced by almost 50%.
Tolcapons farmakokinetik er ikke blevet undersøgt på patienter med nedsat nyrefunktion.
The pharmacokinetics of tolcapone have not been investigated in patients with renal impairment.
Data fra flere end 400 patienter har bekræftet, at tolcapons farmakokinetik er upåvirket af nyrefunktionen over et bredt område af kreatininclearance (30 – 130 ml/ min).
The data of more than 400 patients have confirmed that over a wide range of creatinine clearance values (30-130 mL/ min) the pharmacokinetics of tolcapone are unaffected by renal function.
Dette kan forklares ved, at kun en ubetydelig del af uomdannet tolcapon udskilles i urinen og hovedmetabolitten, tolcapon- glucuronid, udskilles både i urin og i galde (fæces).
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).
Baseret på traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenicitet og toksicitet i forbindelse med reproduktion tyder de prækliniske data ikke på særlig fare for mennesker.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Carcinogenese, mutagenese:
Carcinogenesis, mutagenesis:
3% og 5% af rotter i middel - og højdosisgrupperne renale epitelcelletumorer (adenomer og carcinomer).
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).
Mutagenese:
Mutagenesis:
I en tilendebragt række af mutagenicitetsundersøgelser viste tolcapon sig ikke at være genotoksisk.
Tolcapone was shown not to be genotoxic in a complete series of mutagenicity studies.
Reproduktionstoksicitet:
Toxicity to reproduction:
Det blev påvist, at tolcapon, indgivet alene, hverken er teratogent eller har nogen relevant indflydelse på fertilitet.
Tolcapone, when administered alone, was shown to be neither teratogenic nor to have any relevant effects on fertility.
Calciumhydrogenphosphat (vandfrit) Cellulose, mikrokrystallinsk Polyvidon K30 Natriumstivelsesglycolat Lactosemonohydrat Talcum Magnesiumstearat
Calcium hydrogen phosphate (anhydrous) Microcrystalline cellulose Polyvidone K30 Sodium starch glycollate Lactose monohydrate Talc Magnesium stearate.
Methylhydroxypropylcellulose Talcum Gul jernoxid (E 172) Ethylcellulose Titandioxid (E 171) Triacetin Natriumlaurylsulfat
Methylhydroxypropylcellulose, Talc Yellow iron oxide (E 172) Ethylcellulose Titanium dioxide (E 171) Triacetin Sodium lauryl sulfate
Tasmar findes i PVC/ PE/ PVDC- blisterpakninger (pakningsstørrelser på 30 og 60 filmovertrukne tabletter) og i tabletglas (pakningsstørrelse på 30, 60 og 100 filmovertrukne tabletter).
Tasmar is available in PVC/ PE/ PVDC blisters (pack sizes of 30 and 60 film-coated tablets) and in glass bottles (pack sizes of 30, 60 and 100 film-coated tablets).
6. 6 Eventuelle instruktioner vedrørende anvendelse og håndtering samt bortskaffelse
11 6.6 Instructions for use and handling and disposal
Cedarwood, Chineham Business Park Crockford Lane Basingstoke Hampshire, RG24 8WD Storbritannien
Cedarwood, Chineham Business Park Crockford Lane Basingstoke Hampshire, RG24 8WD
Tasmar 100 mg tabletter:
Tasmar 100 mg tablets:
27. august 1997 / 31 august 2004
27 August 1997 / 31 october2004
Tasmar 200 mg filmovertrukne tabletter.
Tasmar 200 mg film coated tablets.
Tasmar 200 mg er en orange- gul til brun- gul, hexagonal, bikonveks filmovertrukken tablet. ” TASMAR ” og ” 200 ” er præget på den ene side.
Tasmar 200 mg is an orange yellow to brown yellow, hexagonal, biconvex, film-coated tablet. “ TASMAR” and “ 200” are engraved on one side.
Justering af levodopa under Tasmar- behandlingen:
13 Levodopa adjustments during Tasmar treatment:
13 behøvede over 70% af patienterne en reduktion af deres daglige levodopadosis, hvis den daglige levodopadosis var > 600 mg, eller hvis patienterne havde moderate eller svære dyskinesier før behandlingen blev påbegyndt.
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.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
14 4.4 Special warnings and special precautions for use
14 Tasmar skal seponeres, hvis der ikke ses væsentlig klinisk bedring senest 3 uger efter behandlingens påbegyndelse uanset dosis.
Tasmar should be discontinued if substantial clinical benefits are not seen within 3 weeks of the initiation of the treatment regardless of dose.
15 Dyskinesier, kvalme og andre levodopa- relaterede bivirkninger:
Dyskinesia, nausea and other levodopa-associated adverse reactions:
Proteinbinding:
Protein binding:
16 metabolit.
16 Catechols and other drugs metabolised by catechol-O-methyltransferase (COMT):
17 4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
17 4.7 Effects on ability to drive and use machines