natgillin/translations-raw huggingface dataset:
- Det anbefales jævnligt at vurdere den hepatiske -, hæmatopoietiske -, kardiovaskulære - og renale
- Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is
funktion ved forlænget behandling med Stalevo.
recommended during extended therapy with Stalevo.
-. Hos patienter, der får diarré, anbefales opfølgende kontrol af vægten for at undgå et usædvanlig
- For patients experiencing diarrhoea, a follow-up of weight is recommended in order to avoid
stort vægttab
potential excessive weight decrease.
- Der er rapporter om patologisk spillelyst, forøget libido og hyperseksualitet hos Parkinson
- Pathological gambling, increased libido and hypersexuality have been reported in Parkinson’ s
Stalevo.
disease patients treated with dopamine agonists and other dopaminergic treatments such as Stalevo.
- Hvis patienten oplever progressiv anoreksi, asteni og vægttab inden for relativt kort tid, bør det
- For patients who experience progressive anorexia, asthenia and weight decrease within a
overvejes at udføre en generel medicinsk evaluering inklusive undersøgelse af leverfunktionen.
relatively short period of time, a general medical evaluation including liver function should be considered.
- Stalevo indeholder saccharose, og bør ikke anvendes til patienter med arvelig fructoseintolerans,
- Stalevo contains sucrose, and therefore patients with rare hereditary problems of fructose
glucose/ galactosemalabsorption og sucrase- isomaltasemangel.
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Andre antiparkinsonmidler:
Other antiparkinsonian medicinal products:
Indtil nu har der ikke været tegn på interaktioner, der vil udelukke samtidig brug af standard- antiparkinson- lægemidler med Stalevobehandling.
To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Stalevo therapy.
Entakapon i høje doser kan påvirke absorptionen af carbidopa.
Entacapone in high doses may affect the absorption of carbidopa.
Der er imidlertid ikke observeret interaktioner med carbidopa i det anbefalede doseringsskema (200 mg entakapon op til 10 gange dagligt).
However, no interaction with carbidopa has been observed with the recommended treatment schedule (200 mg of entacapone up to 10 times daily).
Der er ikke observeret interaktioner mellem entakapon og seligilin i studier med gentagen dosering hos patienter med Parkinsons sygdom, som blev behandlet med levodopa/ DDC- hæmmer.
Interactions between entacapone and selegiline have been investigated in repeated dose studies in Parkinson's disease patients treated with levodopa/ DDC inhibitor and no interaction was observed.
Antihypersentiva:
Antihypertensives:
Symptomatisk postural hypotension kan opstå, når patienter, som allerede anvender antihypertensiva, får levodopa i tillæg.
Symptomatic postural hypotension may occur when levodopa is added to the treatment of patients already receiving antihypertensives.
Dosisjustering af antihypersentivt lægemiddel kan være nødvendigt.
Dosage adjustment of the antihypertensive agent may be required.
Antidepressiva:
Antidepressants:
Reaktioner, inklusive hypertension og dyskinesier, er i sjældne tilfælde rapporteret ved samtidig indgift af tricykliske antidepressiva og levodopa/ carbidopa.
Rarely, reactions including hypertension and dyskinesia have been reported with the concomitant use of tricyclic antidepressants and levodopa/ carbidopa.
Interaktioner mellem entakapon og imipramin og mellem entakapon og moclobemid har været undersøgt i enkeltdosisstudier hos raske frivillige.
Interactions between entacapone and imipramine and between entacapone and moclobemide have been investigated in single dose studies in healthy volunteers.
MAO- A- hæmmere, tricykliske antidepressiva, noradrenalin- reuptake- hæmmere som f. eks. desipramin, maprotilin og venlafaxin og lægemidler, som metaboliseres via COMT (f. eks. katekollignende forbindelser, paroxetin).
A significant number of Parkinson's disease patients have been treated with the combination of levodopa, carbidopa and entacapone with several active substances including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine and medicinal products that are metabolised by COMT (e. g. catechol-structured compounds, paroxetine).
4. 3 og 4. 4).
However, caution should be exercised when these medicinal products are used concomitantly with Stalevo (see sections 4.3 and 4.4).
Andre lægemidler:
Other active substances:
Dopaminreceptor- antagonister (f. eks. nogle antipsykotika og antiemetika), phenytoin og papaverin kan reducere levodopas terapeutiske virkning.
Patients taking these
Patienter, der anvender disse lægemidler samtidig med Stalevo, bør nøje overvåges med henblik på reduceret terapeutisk respons.
5 medicinal products with Stalevo should be carefully observed for loss of therapeutic response.
S- warfarin.
Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Stalevo may potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as S-warfarin.
I et interaktionsstudie hos raske, frivillige forsøgspersoner ændrede entakapon imidlertid ikke plasmaniveauerne for S- warfarin, mens AUC for R- warfarin øgedes i gennemsnit med 18% [CI90 11 - 26%].
However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11- 26%].
INR- værdierne øgedes i gennemsnit med 13% [CI90 6- 19%].
The INR values increased on average by 13% [CI90 6-19%].
Andre former for interaktioner:
Other forms of interactions:
Levodopa konkurrerer med visse aminosyrer, og absorptionen af Stalevo kan derfor være nedsat hos patienter på proteinrig kost.
Since levodopa competes with certain amino acids, the absorption of Stalevo may be impaired in some patients on high protein diet.
Levodopa og entakapon kan danne chelater med jern i mave- tarmkanalen.
Levodopa and entacapone may form chelates with iron in the gastrointestinal tract.
4. 8).
Therefore, Stalevo and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
In- vitro data:
In vitro data:
Entakapon bindes til humant albumin – bindingssted II, der også binder flere andre lægemidler, inklusive diazepam og ibuprofen.
Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Til dags dato er der derfor ingen tegn på sådanne interaktioner.
Accordingly, to date there has been no indication of such interactions.
Der foreligger ikke tilstrækkelig data fra brug af kombinationen levodopa/ carbidopa/ entakapon hos gravide kvinder.
There are no adequate data from the use of the combination of levodopa/ carbidopa/ entacapone in pregnant women.
5. 3).
Studies in animals have shown reproductive toxicity of the separate compounds (see section 5.3).
Levodopa udskilles i modermælk.
Levodopa is excreted in human breast milk.
Der er set laktationshæmning under behandling med levodopa.
There is evidence that lactation is suppressed during treatment with levodopa.
Carbidopa og entakapon udskilles i mælken hos dyr, men det vides ikke om stofferne udskilles i modermælk hos mennesker.
Carbidopa and entacapone were excreted in milk in animals but is not known whether they are excreted in human breast milk.
Sikkerheden af levodopa, carbidopa eller entakapon hos nyfødte er ikke kendt.
The safety of levodopa, carbidopa or entacapone in the infant is not known.
Stalevo kan i væsentlig grad påvirke evnen til at føre motorkøretøj eller betjene maskiner.
Stalevo may have major influence on the ability to drive and use machines.
Levodopa, carbidopa og entakapon kan sammen forårsage svimmelhed og symptomatisk ortostatisme.
Levodopa, carbidopa and entacapone together may cause dizziness and symptomatic orthostatism.
4. 4).
Patients being treated with Stalevo and presenting with somnolence and/ or sudden sleep onset episodes must be instructed 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 have resolved (see section 4.4).
Følgende afsnit beskriver de bivirkninger, der er rapporteret for levodopa/ carbidopa og for entakapon i kombination med levodopa/ DDC- hæmmer.
The following section describes the undesirable effects reported for levodopa/ carbidopa and for entacapone used in combination with levodopa/ DDC inhibitor.
Levodopa/ carbidopa
Levodopa / carbidopa
De bivirkninger, der hyppigst opstår i forbindelse med levodopa/ carbidopa, skyldes den centrale neurofarmakologiske aktivitet af dopamin.
Adverse reactions that occur frequently with levodopa/ carbidopa are those due to central neuropharmacological activity of dopamine.
Disse reaktioner kan sædvanligvis formindskes ved levodopa- dosisreduktion.
These reactions can usually be diminished by levodopa dosage reduction.
De hyppigst forekommende bivirkninger er dyskinesier, omfattende chorea, dystoni og andre ufrivillige bevægelser.
The most common adverse reactions are dyskinesias including choreiform, dystonic and other involuntary movements.
Muskeltrækninger og blepharospasmer bør tages som tidligt tegn på overvejelse af levodopa- dosisreduktion.
Muscle twitching and blepharospasm may be taken as early signs to consider levodopa dosage reduction.
Kvalme, der også skyldes den øgede centrale dopaminerge aktivitet, er en almindelig bivirkning forårsaget af levodopa/ carbidopa.
Nausea, also related to enhanced central dopaminergic activity, is a common adverse reaction of levodopa/ carbidopa.
6 Andre bivirkninger forbundet med levodopa/ carbidopa- behandling er mentale forandringer inklusive paranoia og psykotiske episoder, depression, med eller uden udvikling af suicidale tendenser, og kognitiv dysfunktion.
6 Other adverse reactions associated with levodopa/ carbidopa therapy are mental changes, including paranoid ideation and psychotic episodes; depression, with or without development of suicidal tendencies; and cognitive dysfunction.
Tilførsel af entakapon til behandling med levodopa/ DDC- hæmmer (carbidopa og benserazid) f. eks. start af Stalevo- behandling hos patienter, der ikke før har fået entakapon, kan forstærke flere af disse mentale forstyrrelser.
Adding of entacapone to levodopa/ DDC inhibitor therapy (carbidopa or benserazide), i. e. initiation of Stalevo treatment in an entacapone naive patient, may aggravate some of these mental changes.
Mindre hyppige bivirkninger ved levodopa/ carbidopa- behandling er uregelmæssig hjerterytme og/ eller palpitationer, ortostatisk hypotensive episoder, bradykinetiske episoder (on- off- fænomen), anoreksi, opkastning, svimmelhed og somnolens.
Less frequent adverse reactions of levodopa/ carbidopa therapy are irregular heart rhythm and/ or palpitations, orthostatic hypotensive episodes, bradykinetic episodes (the'on-off 'phenomenon), anorexia, vomiting, dizziness, and somnolence.
Der er sjældent rapporteret om tilfælde af gastrointestinale blødninger, udvikling af duodenalulcus, hypertension, phlebitis, leukopeni, hæmolytisk og ikke- hæmolytisk anæmi, trombocytopeni, agranulocytose, brystsmerter, dyspnø og paræstesier ved behandling med levodopa/ carbidopa.
Gastrointestinal bleeding, development of duodenal ulcer, hypertension, phlebitis, leucopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis, chest pain, dyspnoea and paraesthesia have occurred rarely with levodopa/ carbidopa.
Der er sjældent rapporteret om kramper med levodopa/ carbidopa, men der er imidlertid ikke fundet årsagssammenhæng med behandling med levodopa/ carbidopa.
Convulsions have occurred rarely with levodopa/ carbidopa; however a causal relationship to levodopa/ carbidopa therapy has not been established.
Dette er som regel reversibelt ved reduktion af dosis eller ophør af behandling.
Parkinson’ s disease patients treated with dopamine agonists and other dopaminergic treatments such as Stalevo, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Andre bivirkninger, der er rapporteret med levodopa, og som derfor også kan være mulige bivirkninger ved Stalevo, omfatter:
Other adverse reactions that have been reported with levodopa and may, therefore, be potential adverse reactions of Stalevo as well, include:
Ataksi, følelsesløshed, øget håndtremor, muskeltrækninger, muskelkrampe, trismus, aktivering af latent Horners syndrom.
Ataxia, numbness, increased hand tremor, muscle twitching, muscle cramp, trismus, activation of latent Horner's syndrome.
Fald og gangforstyrrelser optræder også som mulige uønskede virkninger.
Also falling and gait abnormalities are potential undesirable effects.
Diplopi, tågesyn, udvidede pupiller, okulogyre kriser.
Diplopia, blurred vision, dilated pupils, oculogyric crises.
Mundtørhed, bitter smag, sialorrhoea, dysfagi, bruksisme, hikke, mavesmerter og – uro, obstipation, diarré, flatulens, brændende følelse på tungen.
Dry mouth, bitter taste, sialorrhoea, dysphagia, bruxism, hiccups, abdominal pain and distress, constipation, diarrhoea, flatulence, burning sensation of the tongue.
Urinretention, urininkontinens, mørkfarvet urin, priapisme.
Urinary retention, urinary incontinence, dark urine, priapism.
Rødmen, øget svedtendens, mørkfarvet sved, udslæt, hårtab.
Flushing, increased sweating, dark sweat, rash, hair loss.
Vægtøgning eller vægttab, ødemer.
Weight gain or loss, oedema.
Forvirring, insomnia, mareridt, hallucinationer, vrangforestillinger, agitation, angst og eufori.
Confusion, insomnia, nightmares, hallucinations, delusions, agitation, anxiety, euphoria.
Andre forstyrrelser:
Miscellaneous:
Svaghed, besvimelse, træthed, hovedpine, hæshed, utilpashed, hedestigninger, følelse af stimulering, mærkelige vejrtrækningsmønstre, malignt neuroleptikasyndrom, malignt melanom.
Weakness, faintness, fatigue, headache, hoarseness, malaise, hot flushes, sense of stimulation, bizarre breathing patterns, neuroleptic malignant syndrome, malignant melanoma.
De hyppigste bivirkninger forårsaget af entakapon skyldes den øgede dopaminerge aktivitet og optræder sædvanligvis i begyndelsen af behandlingen.
The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of the treatment.
Reduktion af levodopadosis mindsker reaktionens sværhedsgrad og hyppighed.
Reduction of levodopa dosage decreases the severity and frequency of the reactions.
Den anden hovedgruppe af bivirkninger er gastrointestinale symptomer, inklusive kvalme, opkastning, mavesmerter, obstipation og diarré.
The other major class of adverse reactions are gastrointestinal symptoms, including nausea, vomiting, abdominal pain, constipations and diarrhoea.
Urinen kan misfarves rødbrun af entakapon, men dette er et harmløst fænomen.
Urine may be discoloured reddish-brown by entacapone, but this is a harmless phenomenon.
Nervesystemet Meget almindelig:
The following adverse reactions, listed in Table 1, have been accumulated both from clinical studies
Dyskinesier, forværring af Parkinsons sygdom Almindelig:
7 with entacapone and since the introduction of entacapone into the market for the combination use of entacapone with levodopa/ DDC inhibitor.
Svimmelhed, dystoni, hyperkinesi
Adverse reactions
Mave- tarm- kanalen
Nervous system disorders Very common:
Kvalme Diarré, mavesmerter, mundtørhed, obstipation, opkastning Anoreksi Colitis
Nausea Diarrhoea, abdominal pain, dry mouth, constipation, vomiting Anorexia Colitis
Misfarvning af urin
Urine discolouration
Meget sjælden:
Erythematous or maculopapular rash Very rare:
Erytematøs eller makulopapulært udslæt Urticaria Misfarvning af hud, hår, skæg og negle
Urticaria Skin, hair, beard and nail discolorations
Lever og galdeveje Sjælden:
Hepatobiliary disorders Rare:
Ikke kendt:
Hepatic function tests abnormal Not known:
Påvirkede levertal Leverbetændelse hovedsaglig med galdeophobning (se pkt. 4. 4)
Hepatitis with mainly cholestatic features (see section 4.4)
Insomnia, hallucinationer, forvirring, mareridt, agitation
Insomnia, hallucinations, confusion, nightmares, agitation
* Bivirkningerne er
*Adverse reactions
opdelt efter hyppighed med de mest hyppige først og efterfølgende betegnelser:
are ranked under headings of frequency, the most frequent first, using the
Meget almindelig (≥1/ 10), almindelig (≥1/ 100 til < 1/ 10), ikke almindelig (≥1/ 1. 000 til < 1/ 100), sjælden (≥1/ 10. 000 til < 1/ 1. 000), meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra tilgængelige data, da ingen valide estimater har kunnet opnås i kliniske og epidemiologiske studier).
Very common (≥ 1/ 10); common (1≥ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
Entakapon sammen med levodopa er blevet forbundet med enkeltstående tilfælde af udtalt somnolens i dagtimerne og pludselig indsættende søvnanfald.
Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
Enkeltstående tilfælde af MNS har været rapporteret i forbindelse med pludselig reducering eller afbrydelse af behandlingen med entakapon og andre dopaminerge behandlinger.
Isolated cases of NMS have been reported following the abrupt reduction or discontinuation of entacapone and other dopaminergic treatments.
Enkeltstående tilfælde af rhabdomyolyse har været rapporteret.
Isolated cases of rhabdomyolysis have been reported.
Undersøgelser:
Laboratory tests:
Følgende ændrede laboratorieværdier er rapporteret med levodopa/ carbidopa- behandling, og bør derfor kendes, når der behandles med Stalevo:
The following laboratory abnormalities have been reported with levodopa/ carbidopa treatment and should, therefore, be acknowledged when treating patients with Stalevo:
Sædvanligvis er niveauerne af carbamid, kreatinin og urinsyre lavere ved behandling med levodopa/ carbidopa end ved levodopabehandling alene.
Commonly, levels of blood urea nitrogen, creatinine, and uric acid are lower during administration of levodopa/ carbidopa than with levodopa alone.
Forbigående ændringer indbefatter forhøjede værdier af carbamid, ASAT, ALAT, LDH, bilirubin og alkalisk fosfatase.
Transient abnormalities include elevated values of blood urea, AST (SGOT), ALT (SGPT), LDH, bilirubin, and alkaline phosphatase.
8 Reduceret hæmoglobin, hæmatokrit, øgning i serum glukose og hvide blodlegemer, bakterier og blod i urinen har været rapporteret.
8 Decreased haemoglobin, haematocrit, elevated serum glucose and white blood cells, bacteria and blood in the urine have been reported.
Positiv Coombs test er rapporteret, både for levodopa/ carbidopa og for levodopa alene, men hæmolytisk anæmi er ekstremt sjælden.
Positive Coombs' tests have been reported, both for levodopa/ carbidopa and for levodopa alone, but haemolytic anaemia is extremely rare.
Levodopa/ carbidopa kan forårsage falsk positive resultater, når teststrimler benyttes til undersøgelse af ketonstoffer i urinen, og denne reaktion ændres ikke efter kogning af urinprøven.
Levodopa/ carbidopa may cause false positive result when a dipstick is used to test for urinary ketone and this reaction is not altered by boiling the urine sample.
Brug af glukoseoxidasemetoder kan give falsk negative resultater for glykosuri.
The use of glucose oxidase methods may give false negative results for glycosuria.
Post- marketing data omfatter isolerede tilfælde af overdosis, hvor den største daglige dosis af levodopa og entakapon har været henholdsvis 10. 000 mg og 40. 000 mg.
The post-marketing data includes isolated cases of overdose in which the reported highest daily doses of levodopa and entacapone have been at least 10,000 mg and 40,000 mg, respectively.
I disse tilfælde af en overdosis var de akutte symptomer og tegn: agitation, tilstand af forvirring, koma, bradykardi, ventrikulær takykardi, Cheyne- Stokes respiration, misfarvning af hud, tunge og konjunktiva og kromaturi.
The acute symptoms and signs in these cases of overdose included agitation, confusional state, coma, bradycardia, ventricular tachycardia, Cheyne-Stokes respiration, discolourations of skin, tongue and conjunctiva, and chromaturia.
Behandling af akut overdosering med Stalevo er den samme som ved akut overdosering med levodopa.
Management of acute overdosage with Stalevo therapy is similar to acute overdosage with levodopa.
Dette kan specielt øge eliminationen af entakapon ved at reducere absorptionen/ reabsorptionen fra mave- tarmkanalen.
This may hasten the elimination of entacapone in particular by decreasing its absorption/ reabsorption from the GI tract.
EKG- overvågning bør igangsættes, og patienten bør følges nøje for mulig udvikling af arytmier.
ECG monitoring should be started and the patient carefully monitored for the possible development of arrhythmias.
Behandling med antiarytmika bør indgives ved behov.
If required, appropriate, anti-arrhythmic therapy should be given.
Effekten af dialysebehandling ved overdosering er ukendt.
The value of dialysis in the treatment of overdosage is not known.
Dopa og dopa- derivater,
Pharmacotherapeutic group: dopa and dopa derivatives, ATC code:
I henhold til gældende opfattelse er symptomer ved Parkinsons sygdom knyttet til manglen på dopamin i corpus striatum.
According to the current understanding, the symptoms of Parkinson’ s disease are related to depletion of dopamine in the corpus striatum.
Levodopa metaboliseres i høj grad perifert, og kun en lille del af indgivet dosis når derfor centralnervesystemet, hvis levodopa administreres uden hæmmere af de metaboliske enzymer.
As levodopa is extensively metabolised in the periphery only a small portion of a given dose reaches the central nervous system when levodopa is administered without metabolic enzyme inhibitors.
Carbidopa og benzerazid er perifere DDC- hæmmere, der reducerer den perifere metabolisme af levodopa til dopamin ved at gøre mere levodopa tilgængelig for hjernen.
Carbidopa and benserazide are peripheral DDC inhibitors which reduce the peripheral metabolism of levodopa to dopamine and, thus, more levodopa is available to the brain.
Når decarboxyleringen af levodopa reduceres ved samtidig administration af en DDC- hæmmer, kan en lavere dosis af levodopa benyttes, og forekomsten af uønskede virkninger så som kvalme reduceres.
When decarboxylation of levodopa is reduced with the co-administration of a DDC inhibitor, a lower dose of levodopa can be used and the incidence of undesirable effects such as nausea is reduced.
Ved at hæmme decarboxylase med en DDC- hæmmer bliver COMT hovedmetaboliseringsvejen for levodopa perifert og katalyserer omdannelsen af levodopa til 3- O- methyldopa (3- OMD), en potentiel skadelig metabolit af levodopa.
With inhibition of the decarboxylase by a DDC inhibitor, COMT becomes the major peripheral metabolic pathway catalyzing the conversion of levodopa to 3-O-methyldopa (3-OMD), a potentially harmful metabolite of levodopa.
Entakapon er en reversibel, specifik og hovedsagelig perifert virkende COMT- hæmmer, beregnet til samtidig administrering med levodopa.
Entacapone is a reversible, specific and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa.
Entakapon reducerer clearance af levodopa fra blodet og fører til øget AUC i levodopas farmakokinetiske profil.
Entacapone slows the clearance of levodopa from the bloodstream resulting in an increased area under the curve (AUC) in the pharmacokinetic profile of levodopa.
Daglig ” on- tid ” (timer) med eller uden
The evidence of the therapeutic effects of Stalevo is based on two phase III double-blind studies, in which 376 Parkinson’ s disease patients with end-of-dose motor fluctuations received either