natgillin/translations-raw huggingface dataset:
(SD), (c) analyse-population (mITT); MMRM model for forandring fra udgangspunkt til endepunkt inklusiv behandling, region og besøg som faste påvirkninger, og udgangspunktsværdi som en kovariant; (d) tilstræbt daglig dosis på 100 mg; (e) analyse-population (mITT): data er præsenteret som antallet (procentdel) af patienter i hver gruppe der opfylder respondent-definitionen, (f) chi-square test af sandsynlighedsratio hos behandlingsgruppen sammenlignet med placebo ved brug af en logistisk regressionsmodel med fastsat effekt for behandling og land.
(d) (a) Daily targeted dose, (b) Mean (SD), (c) analysis population (mITT); MMRM model for change from Baseline to Endpoint includes treatment, region, and visit as fixed effects, and baseline value as a covariate; (d) target dose of 100 mg/day; (e) analysis population (mITT); data are presented as the number (percentage) of patients in each group meeting the responder definition (f) chi-square test of the odds ratio of the treatment groups compared to placebo using a logistic regression model, with fixed effects for treatment and country.
Disse symptomer forsvandt ved seponering af lægemidlet, uden mén.
These symptoms resolved on discontinuing the medicinal product, without sequelae.
Der bør udvises forsigtighed, når behandling med safinamid initieres hos patienter med moderat nedsat leverfunktion.
Caution should be exercised when initiating treatment with safinamide in patients with moderate hepatic impairment.
Det forventede mønster af hændelser eller symptomer efter forsætlig eller utilsigtet overdosering med safinamid vil være dem, som relaterer til den farmakodynamiske profil: MAO-B-hæmning med aktivitetsafhængig hæmning af Na+-kanaler.
The expected pattern of events or symptoms following intentional or accidental overdose with Safinamide would be those related to its pharmacodynamic profile: MAO-B inhibition with activity-dependent inhibition of Na channels.
Kombinationen af safinamid med levodopa/carbidopa resulterede i yderligere effekter i studiet af embryo- og fosterudvikling med en højere incidens af føtale skeletabnormiteter end set med begge behandlinger alene.
The combination of safinamide with levodopa/carbidopa resulted in additive effects in the embryo-foetal development studies with a higher incidence of foetal skeletal abnormalities than seen with either treatment alone.
Tilgængelige farmakodynamiske/toksikologiske data fra dyr har vist udskillelse af safinamid i mælk (se pkt.
Available pharmacodynamic/toxicological data in animals have shown excretion of safinamide in milk (for details see 5.3).
Der observeredes ingen nethindedegeneration hos aber trods højere systemisk eksponering end hos gnavere eller hos patienter med maksimal human dosis.
No retinal degeneration was noted in monkeys despite higher systemic exposure than in rodents or in patients at the maximum human dose.
Safinamid udskilles næsten udelukkende via metabolisering, overvejende af amidaser med høj kapacitet, som endnu ikke er karakteriseret.
Safinamide is almost exclusively eliminated via metabolism, largely by high capacity amidases that have not yet been characterized.
Safinamids sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
The safety and efficacy of safinamide in children and adolescents under 18 years of age have not been established.
- Petidin (en stærk smertestillende medicin).
- Pethidine (a strong pain killer).
Ved koncentrationer på 50µM hæmmede safinamid OATP1A2 og OATP2P1.
At concentrations of 50µM, safinamide inhibited OATP1A2 and OATP2P1.
Generelt kan safinamid anvendes med selektive serotonin genoptagningshæmmere (selective serotonin re-uptake inhibitors, SSRI) ved den lavest effektive dosis med forsigtighed over for serotoninerge symptomer.
In general, safinamide may be used with selective serotonin re-uptake inhibitors (SSRIs) at the lowest effective dose, with caution for serotoninergic symptoms.
Dyrestudier viser, at behandling med safinamid er forbundet med bivirkninger på hunrotters reproduktive ydeevne og sædkvalitet.
Animal studies indicate that safinamide treatment is associated with adverse reactions on female rat reproductive performance and sperm quality.
14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Virkningen af safinamid som tillægsbehandling i mellemfasen eller den senere fase af PD (late-stage PD, LSPD) hos patienter med motoriske fluktuationer, der på nuværende tidspunkt behandles med Ldopa alene eller i kombination med andre PD-lægemiddelprodukter, blev evalueret i to dobbeltblindede placebo-kontrollerede studier: Studie SETTLE (studie 27919; 50-100 mg/dag i 24 uger) og studie 016/018 (50 og 100 mg/dag i 2 år, dobbeltblindet placebo-kontrolleret studier).
The efficacy of safinamide as add-on treatment in mid-to late-stage PD (LSPD) patients with motor fluctuations, currently receiving L-dopa alone or in combination with other PD medicinal products, was evaluated in two double-blind, placebo-controlled studies: Study SETTLE (Study 27919; 50-100 mg/day; 24 weeks), and Study 016/018 (50 and 100 mg/day; 2-year, double-blind, placebo-controlled study).
De opnåede resultater fra karcinogenicitetsstudier hos mus og rotter viste ingen tegn på tumorigent potentiale relateret til safinamid ved systemisk eksponering på op til 2,3 til 4,0 gange respektive den forventede systemiske eksponering hos patienter, der fik den maksimale terapeutiske dosis.
The results obtained from carcinogenicity studies in mice and rats showed no evidence of tumorigenic potential related to safinamide at systemic exposures up to 2.3 to 4.0 times respectively, the anticipated systemic exposure in patients given the maximal therapeutic dose.
Farmakokinetiske populationsmodeller udviklet fra studier med patienter med Parkinsons sygdom viser, at de farmakokinetiske og farmakodynamiske effekter af safinamid ikke var afhængige af alder, køn, vægt, nyrefunktion og eksponering for levodopa, hvilket indikerer, at der ikke kræves dosisjustering på baggrund af disse variable.
Population PK models developed from studies in patients with Parkinson's disease indicate that the pharmacokinetic and pharmacodynamics effects of safinamide were not dependent on age, gender, weight, renal function and exposure to levodopa, indicating that dose adjustments will not be required based on these variables.
Der blev kun observeret leverhypertrofi og ændringer i fedt i gnaveres lever ved eksponeringer svarende til mennesker.
Liver hypertrophy and fatty changes were seen only in rodent livers at exposures similar to humans.
Især bør samtidig brug af safinamid og fluoxetin eller fluvoxamin undgås eller, hvis samtidig behandling er nødvendig, bør disse lægemidler anvendes i lave doser (se pkt.
In particular, the concomitant use of safinamide and fluoxetine or fluvoxamine should be avoided, or if concomitant treatment is necessary these medicinal products should be used at low doses (see section 4.5).
Amning Xadago udskilles sandsynligvis i modermælk.
Breast Feeding Xadago is likely to be excreted in breast milk.
Hvis du lider af moderat nedsat leverfunktion, må du ikke tage mere end 50 mg om dagen.
If you suffer from moderately reduced liver function, you should not take more than 50 mg a day; your doctor will advise if this applies to you.
Moderat eller svært nedsat nyrefunktion ændrede ikke eksponeringen for safinamid sammenlignet med raske forsøgspersoner (se pkt.
Moderate or severe renal impairment did not alter the exposure to safinamide, compared to healthy subjects (see section 4.2).
‘DenN-dealkylerede syre' (NW-1689) gennemgår konjugation med glucuronsyre og giver acylglukuronid.
The ‘N-dealkylated acid' (NW-1689) undergoes conjugation with glucuronic acid yielding its acyl glucuronide.
I et præ- og postnatalt udviklingsstudie med rotter, observeredes dødelighed hos unger, manglende mælk i maven og neonatal hepatotoksicitet ved dosisniveauer svarende til den forventede kliniske eksponering.
In a pre- and postnatal developmental rat study, pup mortality, absence of milk in the stomach and neonatal hepatotoxicity were observed at dose levels similar to the anticipated clinical exposure.
Det anbefales at monitorere patienter, når safinamid tages sammen med lægemidler, som er BCRP-substrater (f.eks. rosuvastatin, pitavastatin, pravastatin, ciprofloxacin, methotrexat, topotecan, diclofenac og glibenclamid) og at henvise til deres produktresuméer for at afgøre, om en dosisjustering er nødvendig.
It is recommended to monitor patients when safinamide is taken with medicinal products that are BCRP substrates (e.g., rosuvastatin, pitavastatin, pravastatin, ciprofloxacin, methotrexate, topotecan, diclofenac or glyburide) and to refer to their SmPCs to determine if a dose adjustment is needed.
Hos mennesker elimineres safinamid næsten udelukkende via metabolisering (urinudskillelse af uforandret safinamid var <10 %) hovedsageligt formidlet gennem højkapacitet-amidase, som endnu ikke er karakteriseret.
In humans, safinamide is almost exclusively eliminated via metabolism (urinary excretion of unchanged safinamide was <10%) mediated principally through high capacity amidases, that have not yet been characterized.
Samlede analyseresultater af bivirkningsdata fra placebo-kontrollerede studier med patienter med Parkinsons sygdom tyder på, at samtidig administration af safinamid sammen med en bred kategori af almindeligt anvendte lægemidler i denne patientgruppe (antihypertensiva, beta-blokkere, kolesterolsænkende, ikke-steroide anti-inflammatoriske, protonpumpe-hæmmere, antidepressiva, etc.) ikke var forbundet med en øget risiko for bivirkninger.
Pooled analyses of adverse event data from placebo controlled studies in Parkinson's disease patients indicate that the concomitant administration of safinamide together with a broad category of commonly used medicinal products in this patient population (antihypertensive, beta-blockers cholesterol lowering, non-steroidal anti-inflammatory medicinal products, proton pump inhibitors, antidepressants, etc.) was not associated with an increased risk for adverse events.
Metabolit NW-1153 er substrat for OAT3 ved klinisk relevante koncentrationer.
The metabolite NW-1153 is a substrate for OAT3 at clinically relevant concentrations.
Systemorganklasse Meget almindelig
System Organ Class
Eosinofili, lymfopeni
Eosinophilia, lymphopenia
- hvis du tager nogen af følgende lægemidler: Monoaminooxidasehæmmere (MAO-hæmmere) såsom selegilin, rasagilin, moclobamid, phenelzin, isocarboxazid, tranylcypromin (f.eks. til behandling af Parkinsons sygdom eller depression, eller til behandling af en anden tilstand).
- If you are taking any of the following medicines: - Monoamine oxidase (MAO) inhibitors such as selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine (e.g. for treatment of Parkinson's disease or depression, or used for any other condition).
Symptomerne på en overdreven MAO-B-hæmning (forøgelse i dopamin-niveau), kan omfatte hypertension, postural hypotension, hallucinationer, agitation, kvalme, opkastning og dyskinesi.
The symptoms of an excessive MAO-B inhibition (increase in dopamine level) could include hypertension, postural hypotension, hallucinations, agitation, nausea, vomiting, and dyskinesia.
Fertilitetsstudier med hunrotter viste reduceret antal implantationer og corpora lutea ved eksponeringer på over 3 gange den forventede humane eksponering.
Fertility studies in female rats showed reduced number of implantations and corpora lutea at exposures in excess of 3 times the anticipated human exposure.
Hver tablet indeholder 50 mg eller 100 mg safinamid (som methansulfonat).
Each tablet contains 50 mg or 100 mg of safinamide (as methansulfonate).
Der blev observeret nethindedegeneration hos gnavere efter gentagne doseringer med safinamid, som resulterede i systemisk eksponering, som lå under den forventede systemiske eksponering hos patienter, der fik maksimal terapeutisk dosis.
Retinal degeneration was observed in rodents after repeated safinamide dosing resulting in systemic exposure below the anticipated systemic exposure in patients given the maximal therapeutic dose.
Xadago er indiceret til behandling af voksne patienter med idiopatisk Parkinsons sygdom (PD), som tillægsbehandling til en stabil dosis levodopa (L-dopa) alene eller i kombination med andre lægemidler mod PD hos fluktuerende patienter i mellemfasen eller den senere fase.
Xadago is indicated for the treatment of adult patients with idiopathic Parkinson's disease (PD) as addon therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.
Hanrotter viste en moderat unormal morfologi og reduceret hastighed af sædceller ved eksponeringer over 1,4 gange den forventede humane eksponering.
Male rats showed minor abnormal morphology and reduced speed of sperm cells at exposures in excess of 1.4 times the anticipated human exposure.
Der er indberettet følgende bivirkninger hos patienter i mellemfasen eller den senere fase af Parkinsons sygdom (patienter, der tog safinamid som tillægsbehandling til levodopa alene eller i kombination med andre lægemidler for Parkinsons sygdom):
The following side effects have been reported in patients at a mid- to late-stage of Parkinson's disease (patients taking safinamide as add-on to levodopa alone or in combination with other medicines for Parkinson's disease):
NW-1153 hæmmer ikke OCT2, MATE1 eller MATE2-K ved koncentrationer op til 5µM.
NW-1153 is not an inhibitor of OCT2, MATE1, or MATE2-K up to concentrations of 5µM.
PD varighed (år) (b)
PD Duration (years) (b)
Da dette kan være en klasse-effekt, er samtidig administration af safinamid og petidin kontraindiceret (se pkt.
As this may be a class-effect, the concomitant administration of safinamide and pethidine is contraindicated (see section 4.3).
In vivo og in vitro farmakodynamisk interaktion mellem lægemidler
In vivo and in vitro pharmacodynamic drug interactions
Dyskinesi var den mest almindelige bivirkning, der blev indrapporteret hos patienter behandlet med safinamid sammen med L-dopa alene eller sammen med andre PD-behandlinger.
Dyskinesia was the most common adverse reaction reported in safinamide patients when used in combination with L-dopa alone or in combination with other PD treatments.
Der har været indberetninger om lægemiddelinteraktioner ved samtidig brug af dextromethorphan og ikke-selektive MAO-hæmmere.
There have been reports of medicinal product interactions with the concomitant use of dextromethorphan and non-selective MAO inhibitors.
Hypertension, hypotension, åreknuder
Hypertension, hypotension, varicose vein
In vivo og in vitro farmakokinetiske lægemiddelinteraktioner
In vivo and in vitro pharmacokinetic drug interactions
Metabolit NW-1153 er ikke et substrat for OCT2 eller OAT1, men det er et substrat for OAT3.
Metabolite NW-1153 is not a substrate for OCT2, or OAT1, but it is substrate for OAT3.
hvis du har en alvorlig leverlidelse - hvis du har en øjenlidelse, som kan medføre, at du risikerer potentiel skade på din nethinde (de lysfølsomme lag i den bageste del af øjnene), f.eks. albinisme (pigmentmangel i hud og øjne), retinal degeneration (tab af celler fra det lysfølsomme lag bag i øjet) eller uveitis (inflammation inde i øjet), arvet retinopati (arvet øjenlidelse) eller alvorlig progressiv diabetisk retinopati (et progressivt synstab pga. diabetes).
- If you have been told that you have severe liver problems - If you have an eye condition which might put you at risk of potential damage to your retina (the light sensitive layers at the back of your eyes), e.g. albinism (lack of pigment in your skin and eyes), retinal degeneration (loss of cells from light sensitive layer at the back of the eye), or uveitis (inflammation inside of the eye), inherited retinopathy (inherited disorders of the vision), or severe progressive diabetic retinopathy (a progressive decrease of the vision due to diabetes).
Hos patienter i mellemfasen eller den senere fase, der oplever pludselige skift mellem ”on” perioder hvor de kan bevæge sig og ”off” perioder hvor de har problemer med at bevæge sig, tilføjes Xadago til en stabil dosis af lægemidlet kaldet levodopa, alene eller i kombination med andre lægemidler for Parkinsons sygdom.
In mid- to late-stage patients experiencing sudden switches between being “ON” and able to move and being “OFF” and having difficulties moving about, Xadago is added to a stable dose of the medicine called levodopa alone or in combination with other medicines for Parkinson's disease.
Du bør være forsigtig med at betjene farlige maskiner eller køre bil, indtil du er rimelig sikker på, at Xadago ikke påvirker dig på nogen måde.
Somnolence and dizziness may occur during safinamide treatment; you should be cautious about operating hazardous machines or driving, until you are reasonably certain that Xadago does not affect you in any way.
Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller skraldespanden..
Do not throw away any medicines via wastewater or household waste.
Impulskontrolforstyrrelser: Ludomani, øget kønsdrift, hyperseksualitet, købetrang, overspisning og anden tvangsspisning kan opstå hos patienter behandlet med dopaminagonister og/eller andre dopaminerge behandlinger.
Impulse control disorders; pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Patienter og plejere bør gøres opmærksomme på de adfærds-symptomer ved impulskontrolforstyrrelser, der er observeret hos patienter, der behandles med MAO-hæmmere, inklusive tilfælde af tvangshandlinger, tvangstanker, patologisk gambling, øget libido, hyperseksualitet, impulsiv opførsel og kompulsiv købe- eller forbrugsadfærd.
Patients and carers should be made aware of the behavioural symptoms of ICDs that were observed in patients treated with MAO-inhibitors, including cases of compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying.
Safinamid bør ikke gives til fertile kvinder, medmindre der bruges tilstrækkelig prævention.
Safinamide should not be given to women of childbearing potential unless adequate contraception is practiced.
Almindelig (kan påvirke op til 1 ud af 10 personer): søvnløshed, svært ved at foretage frivillige bevægelser, træthed, svimmelhed, hovedpine, forværring af Parkinsons sygdom, sløret øjenlinse, lavt blodtryk, når du rejser dig til stående stilling, kvalme, falden.
Common (may affect up to 1 in 10 people): insomnia, difficulty in performing voluntary movements, feeling sleepy, dizziness, headache, worsening of Parkinson's disease, clouding of the lens of the eye, fall in blood pressure when rising to a standing position, nausea, falling.
SE Standardfejl, SD standardafvigelse, LSM Least Square Mean, LS Diff. Least Square Difference vs placebo mITT population: undersøgelse 016/018 - placebo (n=212), safinamid 50 mg/dag (n=217) og 100 mg/dag (n=216), og SETTLE - placebo (n=270), safinamid 50-100 mg/dag (n=273).
Least Square Difference vs Placebo mITT Population: Study 016/018 - Placebo (n=212), safinamide 50 mg/day (n=217) and 100 mg/day (n=216), and SETTLE - Placebo (n=270), safinamide 50-100 mg/day (n=273).
Patienter bør derfor advares mod at betjene farlige maskiner herunder motorkøretøjer, indtil de er rimeligt sikre på, at safinamid ikke påvirker dem negativt.
Somnolence and dizziness may occur during safinamide treatment, therefore patients should be cautioned about using hazardous machines, including motor vehicles, until they are reasonably certain that safinamide does not affect them adversely.
Nedsat appetit, hypertriglyceridæmi, øget appetit, hyperkolesterolemi, hyperglykæmi
Decreased appetite, hypertriglyceridaemia, increased appetite, hypercholesterolaemia, hyperglycaemia,
I studier med embryoføtal udvikling hos rotter og kaniner induceredes misdannelser ved safinamid-eksponeringer hhv. 2 og 3 gange højere end humane kliniske eksponeringer.
In embryo-foetal developmental studies in rats and rabbits malformations were induced at safinamide exposures 2 and 3-fold above human clinical exposure, respectively.
Safinamid kan hæmme BCRP forbigående in vitro.
Safinamide may transiently inhibit BCRP in vitro.
Bruges til patienter med albinisme, retinal degeneration, uveitis, arvelig retinopati eller alvorlig progressiv diabetisk retinopati (se pkt.
Use in patients with albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy (see sections 4.4 and 5.3).
Xadago bør ikke anvendes under amning.
Xadago should not be used during breast-feeding.
Undersøgelse af PD-patienter i mellemfasen eller den senere fase
Studies in mid- to late-stage PD patients
Med MAOhæmmere er der blevet rapporteret om lægemiddelinteraktioner med samtidig anvendelse af sympatomimetiske lægemidler.
With MAO-inhibitors there have been reports of drug interactions with concomitant use of sympathomimetic medicinal products.
Endelig dannes ‘N-dealkyleret syre (NW-1689) ved oxidativ spaltning af aminbinding af enten safinamid (mindre) eller den primære safinamid syremetabolit (NW-1153) (større).
Finally the ‘N-dealkylated acid' (NW-1689) is formed by oxidative cleavage of the amine bond of either safinamide (minor) or the primary safinamide acid metabolite (NW-1153) (major).
NW-1153 har en lav systemisk eksponering (1/10 af safinamid).
The systemic exposure of NW-1153 is low (1/10 of parent safinamide).
Hvis du holder op med at tage Xadago
If you stop taking Xadago
Hvis du har taget for mange Xadago-tabletter, kan du udvikle forhøjet blodtryk, angst, forvirring, glemsomhed, søvnighed, svimmelhed, føle dig syg eller blive syg, udvidede pupiller eller få ukontrollerbar rysten.
If you have taken too many Xadago tablets, you may develop raised blood pressure, anxiety, confusion, forgetfulness, sleepiness, lightheadedness; feel sick or be sick; dilated pupils or develop involuntary jerky movements.
Den primære vej involverer hydrolytisk oxidation af amiddelen, som fører til den primære metabolit 'safinamidsyre' (NW-1153).
The principal pathway involves hydrolytic oxidation of the amide moiety leading to the primary metabolite ‘safinamide acid' (NW-1153).
Derfor bør Xadago ikke tages under graviditet eller af kvinder i den fødedygtige alder, der ikke anvender passende prævention.
Xadago should not be used during pregnancy or by women of childbearing potential not practicing adequate contraception.
Hvis du har glemt at tage Xadago
If you forget to take Xadago
Den anden vej involverer oxidativ spaltning af etherbindingen og danner ‘O-debenzyleret safinamid' (NW-1199).
Another pathway involves oxidative cleavage of the ether bond forming ‘O-debenzylated safinamide' (NW-1199).
Safinamid bør ikke gives til patienter med oftalmologisk historie, som kan medfører øget risiko for potentielle nethinde-effekter (f.eks. anamnese med arvelig nethindesygdom, eller historie med uveitis), se pkt.
Safinamide should not be administered to patients with ophthalmological history that would put them at increased risk for potential retinal effects (e.g., family history of hereditary retinal disease, or history of uveitis) see sections 4.3 and 5.3.
ON tid uden generende dyskinesi (timer) (c)
ON time without troublesome dyskinesia (hrs) (c) Baseline (b)
Xadagos virkning og anvendelse Det skal du vide før du begynder at tage Xadago Sådan skal du tage Xadago Bivirkninger
What Xadago is and what it is used for What you need to know before you take Xadago How to take Xadago