FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: The metabolite NW-1153 is a substrate for OAT3 at clinically relevant concentrations.
Danish: Metabolit NW-1153 er substrat for OAT3 ved klinisk relevante koncentrationer.
English: System Organ Class
Danish: Systemorganklasse Meget almindelig
English: Eosinophilia, lymphopenia
Danish: Eosinofili, lymfopeni
English: - 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).
Danish: - 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).
English: The symptoms of an excessive MAO-B inhibition (increase in dopamine level) could include hypertension, postural hypotension, hallucinations, agitation, nausea, vomiting, and dyskinesia.
Danish: Symptomerne på en overdreven MAO-B-hæmning (forøgelse i dopamin-niveau), kan omfatte hypertension, postural hypotension, hallucinationer, agitation, kvalme, opkastning og dyskinesi.
English: Fertility studies in female rats showed reduced number of implantations and corpora lutea at exposures in excess of 3 times the anticipated human exposure.
Danish: Fertilitetsstudier med hunrotter viste reduceret antal implantationer og corpora lutea ved eksponeringer på over 3 gange den forventede humane eksponering.
English: Each tablet contains 50 mg or 100 mg of safinamide (as methansulfonate).
Danish: Hver tablet indeholder 50 mg eller 100 mg safinamid (som methansulfonat).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Male rats showed minor abnormal morphology and reduced speed of sperm cells at exposures in excess of 1.4 times the anticipated human exposure.
Danish: Hanrotter viste en moderat unormal morfologi og reduceret hastighed af sædceller ved eksponeringer over 1,4 gange den forventede humane eksponering.
English: 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):
Danish: 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):
English: NW-1153 is not an inhibitor of OCT2, MATE1, or MATE2-K up to concentrations of 5µM.
Danish: NW-1153 hæmmer ikke OCT2, MATE1 eller MATE2-K ved koncentrationer op til 5µM.
English: PD Duration (years) (b)
Danish: PD varighed (år) (b)
English: As this may be a class-effect, the concomitant administration of safinamide and pethidine is contraindicated (see section 4.3).
Danish: Da dette kan være en klasse-effekt, er samtidig administration af safinamid og petidin kontraindiceret (se pkt.
English: In vivo and in vitro pharmacodynamic drug interactions
Danish: In vivo og in vitro farmakodynamisk interaktion mellem lægemidler
English: 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.
Danish: 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.
English: There have been reports of medicinal product interactions with the concomitant use of dextromethorphan and non-selective MAO inhibitors.
Danish: Der har været indberetninger om lægemiddelinteraktioner ved samtidig brug af dextromethorphan og ikke-selektive MAO-hæmmere.
English: Hypertension, hypotension, varicose vein
Danish: Hypertension, hypotension, åreknuder
English: In vivo and in vitro pharmacokinetic drug interactions
Danish: In vivo og in vitro farmakokinetiske lægemiddelinteraktioner
English: Metabolite NW-1153 is not a substrate for OCT2, or OAT1, but it is substrate for OAT3.
Danish: Metabolit NW-1153 er ikke et substrat for OCT2 eller OAT1, men det er et substrat for OAT3.
English: - 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).
Danish: 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).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller skraldespanden..
English: 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.
Danish: Impulskontrolforstyrrelser: Ludomani, øget kønsdrift, hyperseksualitet, købetrang, overspisning og anden tvangsspisning kan opstå hos patienter behandlet med dopaminagonister og/eller andre dopaminerge behandlinger.
English: 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.
Danish: 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.
English: Safinamide should not be given to women of childbearing potential unless adequate contraception is practiced.
Danish: Safinamid bør ikke gives til fertile kvinder, medmindre der bruges tilstrækkelig prævention.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: Patienter bør derfor advares mod at betjene farlige maskiner herunder motorkøretøjer, indtil de er rimeligt sikre på, at safinamid ikke påvirker dem negativt.
English: Decreased appetite, hypertriglyceridaemia, increased appetite, hypercholesterolaemia, hyperglycaemia,
Danish: Nedsat appetit, hypertriglyceridæmi, øget appetit, hyperkolesterolemi, hyperglykæmi
English: In embryo-foetal developmental studies in rats and rabbits malformations were induced at safinamide exposures 2 and 3-fold above human clinical exposure, respectively.
Danish: I studier med embryoføtal udvikling hos rotter og kaniner induceredes misdannelser ved safinamid-eksponeringer hhv. 2 og 3 gange højere end humane kliniske eksponeringer.
English: Safinamide may transiently inhibit BCRP in vitro.
Danish: Safinamid kan hæmme BCRP forbigående in vitro.
English: Use in patients with albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy (see sections 4.4 and 5.3).
Danish: Bruges til patienter med albinisme, retinal degeneration, uveitis, arvelig retinopati eller alvorlig progressiv diabetisk retinopati (se pkt.
English: Xadago should not be used during breast-feeding.
Danish: Xadago bør ikke anvendes under amning.
English: Studies in mid- to late-stage PD patients
Danish: Undersøgelse af PD-patienter i mellemfasen eller den senere fase
English: With MAO-inhibitors there have been reports of drug interactions with concomitant use of sympathomimetic medicinal products.
Danish: Med MAOhæmmere er der blevet rapporteret om lægemiddelinteraktioner med samtidig anvendelse af sympatomimetiske lægemidler.
English: 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).
Danish: Endelig dannes ‘N-dealkyleret syre (NW-1689) ved oxidativ spaltning af aminbinding af enten safinamid (mindre) eller den primære safinamid syremetabolit (NW-1153) (større).
English: The systemic exposure of NW-1153 is low (1/10 of parent safinamide).
Danish: NW-1153 har en lav systemisk eksponering (1/10 af safinamid).
English: If you stop taking Xadago
Danish: Hvis du holder op med at tage Xadago
English: 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.
Danish: 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.
English: The principal pathway involves hydrolytic oxidation of the amide moiety leading to the primary metabolite ‘safinamide acid' (NW-1153).
Danish: Den primære vej involverer hydrolytisk oxidation af amiddelen, som fører til den primære metabolit 'safinamidsyre' (NW-1153).
English: Xadago should not be used during pregnancy or by women of childbearing potential not practicing adequate contraception.
Danish: Derfor bør Xadago ikke tages under graviditet eller af kvinder i den fødedygtige alder, der ikke anvender passende prævention.
English: If you forget to take Xadago
Danish: Hvis du har glemt at tage Xadago
English: Another pathway involves oxidative cleavage of the ether bond forming ‘O-debenzylated safinamide' (NW-1199).
Danish: Den anden vej involverer oxidativ spaltning af etherbindingen og danner ‘O-debenzyleret safinamid' (NW-1199).
English: 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.
Danish: 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.
English: ON time without troublesome dyskinesia (hrs) (c) Baseline (b)
Danish: ON tid uden generende dyskinesi (timer) (c)
English: What Xadago is and what it is used for What you need to know before you take Xadago How to take Xadago
Danish: Xadagos virkning og anvendelse Det skal du vide før du begynder at tage Xadago Sådan skal du tage Xadago Bivirkninger
English: Serious adverse reactions have been reported with the concomitant use of selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic/tetracyclic antidepressants and MAO inhibitors (see section 4.4).
Danish: Der har været indberettet alvorlige bivirkninger ved samtidig brug af selektive serotonin genoptagningshæmmere (SSRI), serotonin norepinefrin genoptagningshæmmere (serotonin norepinephrine reuptake inhibitors, SNRI), tricykliske/tetracykliske antidepressiva og MAO-hæmmere (se pkt.
English: Hypromellose Macrogol (6000) Titanium dioxide (E171) Iron oxide red (E172) Mica (E555)
Danish: Tabletovertræk: hypromellose, macrogol (6000), titandioxid (E171), jernoxid rød (E172), kaliumaluminiumsilikat (E555).
English: 4.4 Special warnings and precautions for use
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Generel advarsel
English: UPDRS III (c) Baseline (b)
Danish: UPDRS III (c) Udgangspunkt (b)
English: In view of the MAO inhibitory activity of safinamide, concomitant administration of safinamide and sympathomimetics, such as those present in nasal and oral decongestants or cold medicinal products containing ephedrine or pseudoephedrine, requires caution (see section 4.4).
Danish: I betragtning af den MAO-hæmmende virkning af safinamid skal der udvises forsigtighed ved samtidig administration af safinamid og sympatomimetika, som dem, der findes i nasale og orale dekongestanter eller lægemidler mod forkølelse, som indeholder efedrin eller pseudoefedrin (se pkt.
English: Randomized Age (years) (b)
Danish: Alder (år) (b)
English: Gambling
Danish: Hasardspil
English: Seek medical advice in case of hypertensive crisis (very high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, increase level of enzyme creatine kinase in your blood), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension.
Danish: Søg råd hos lægen i tilfælde af hypertensiv krise (meget højt blodtryk, kollaps), malignt neuroleptika syndrom (forvirring, svedtendens, muskelstivhed, forhøjet legemstemperatur, øget niveau af enzym kreatinin-kinase i blodet), serotoninsyndrom (forvirring, forhøjet blodtryk, muskelstivhed, hallucinationer) samt hypotension.
English: In vitro metabolism studies have indicated that there is no meaningful induction or inhibition of cytochrome P450, CYP2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A3/5 at concentrations which are relevant (Cmax of free safinamide 0.4 µM at 100 mg/day) in man.
Danish: CYP2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A3/5 ved relevante koncentrationer (Cmax af frit safinamid 0,4 µM ved 100 mg/dag) hos mennesker.
English: In view of the MAO inhibitory activity of safinamide, the concomitant administration of safinamide and dextromethorphan is not recommended, or if concomitant treatment is necessary, it should be used with caution (see section 4.4).
Danish: I betragtning af den MAO-hæmmende virkning af safinamid frarådes samtidig administration af safinamid og dextromethorphan, eller hvis samtidig behandling er nødvendig, skal der udvises forsigtighed (se pkt.
English: Arterial spasm, arteriosclerosis, hypertensive crisis
Danish: Arteriespasme, åreforkalkning, hypertensiv krise
English: Drug effect decreased, drug intolerance, feeling cold, malaise, pyrexia, xerosis
Danish: Nedsat lægemiddeleffekt, lægemiddeltolerance, kuldefølelse, utilpashed, pyreksi, xerose
English: Other medicines and Xadago
Danish: Brug af anden medicin sammen med Xadago
English: At least 7 days must elapse between discontinuation of safinamide and initiation of treatment with MAO inhibitors or pethidine (see section 4.3 and 4.5).
Danish: Der skal gå mindst 7 dage mellem seponering af safinamid og opstart af behandling med MAOhæmmere eller petidin (se pkt.
English: Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors, such as hypertensive crisis (high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, CPK increase), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension.
Danish: Alvorlige bivirkninger er kendt ved samtidig brug af SSRI´er, SNRI´er, tricykliske/tetracykliske antidepressiva og MAO-hæmmere, som hypertensiv krise (højt blodtryk, kollaps), malignt neuroleptika-syndrom (forvirring, svedtedens, muskelstivhed, hypertermi, øget CPK), serotoninsyndrom (forvirring, hypertension, muskelstivhed, hallucinationer), hypotension.
English: +) channels, and modulation of stimulated release of glutamate.
Danish: Safinamid er forbundet med tilstandsafhængig hæmning af spændingsstyrede natriumkanaler (Na+) og modulation af stimuleret frigivelse af glutamat.
English: Erectile dysfunction Benign prostatic hyperplasia, breast disorder, breast pain
Danish: Erektil dysfunktion Prostatahyperlapsi, brystlidelse, brystsmerter
English: Basal cell carcinoma
Danish: Basalcellekræft
English: What you need to know before you take Xadago
Danish: Det skal du vide, før du begynder at tage Xadago
English: There have been reports of medicinal product interactions with the concomitant use of MAO inhibitors and sympathomimetic medicinal products.
Danish: Der har været indberetninger om lægemiddelinteraktioner ved samtidig brug af MAO-hæmmere og sympatomimetiske lægemidler.
English: This interaction has the potential to reduce the clearance of NW1153 and increase its exposure; however the systemic exposure of NW-1153 is low (1/10 of parent safinamide), and as it is metabolised to secondary and tertiary metabolites, it is unlikely to be of any clinical relevance.
Danish: Den systemiske eksponering af NW-1153 er dog lav (1/10 af safinamid), og da det metaboliseres til sekundære og tertiære metabolitter, er det usandsynligt, at det har nogen klinisk relevans.
English: Male rat fertility is not affected (see section 5.3).
Danish: Fertiliteten hos hanrotter påvirkes ikke (se pkt.
English: C-safinamide accounted for approximately 30% of the total radioactivity AUC0-24h, indicative of an extensive metabolism.
Danish: Et massebalancestudie viste, at plasma AUC0-24t med uændret 14C-safinamid udgjorde ca. 30 % af den samlede radioaktivitet AUC0-24t, hvilket indikerer en omfattende metabolisme.
English: Secondary efficacy parameters included OFF Time, UPDRS II and III (Unified Parkinson's Disease Rating Scale - sections II and III), and CGI-C (Clinical Global Impression of Change)
Danish: Sekundær virkningsparameter inkluderer OFF tid, UPDRS ll og lll (Unified Parkinson's Disease Rating Scale (samlet vurderingsskema for Parkinson) - pkt.
English: Acrochordon, melanocytic naevus, seborrhoeic keratosis, skin papilloma
Danish: Acrochordon, melanocytisk nævus, basalcellepapillom, hudpapillom
English: Dyskinesia somnolence dizziness, headache, Parkinson's disease
Danish: Bevægeforst yrrelser, somnolens, svimmelhed, hovedpine, Parkinsons sygdom
English: Palpitations, tachycardia, sinus bradycardia, arrhythmia
Danish: Hjertebanken, takykardi, bradykardi, arytmi
English: Fatigue, asthenia, gait disturbance, oedema peripheral, pain, feeling hot
Danish: Træthed, asteni, gangforstyrrelser, perifert ødem, smerter, varmefølelse
English: No dose adjustment is required in patients with mild hepatic impairment.
Danish: Der kræves ingen dosisjustering hos patienter med let nedsat leverfunktion.
English: Microcrystalline cellulose Crospovidone type A Magnesium stearate Silica, colloidal anhydrous
Danish: Tabletkerne: Mikrokrystallinsk cellulose, crospovidon type A, magnesiumstearat, silica, kolloid vandfri
English: Safinamide transiently inhibits BCRP in the small intestine (see section 4.5).
Danish: Safinamid hæmmer BCRP i tyndtarmen midlertidigt (se pkt.
English: Safinamide treatment has not been associated with any increase in the appearance of ICDs.
Danish: Behandling med safinamid er ikke forbundet med øget forekomst af impulskontrolforstyrrelser.
English: 20091 Bresso (MI) - Italy Tel: +39 02 665241
Danish: 20091 Bresso (MI) - Italien tlf.: +39 02 665241 fax: +39 02 66501492:
English: What Xadago contains - The active substance is safinamide.
Danish: Pakningsstørrelser og yderligere oplysninger Xadago indeholder: - Aktivt stof: Safinamid.
English: Use in patients with severe hepatic impairment (see section 4.2).
Danish: Bruges til patienter med svært nedsat leverfunktion (se pkt.
English: Concomitant treatment with other monoamine oxidase (MAO) inhibitors (see sections 4.4 and 4.5).
Danish: Samtidig behandling med andre monoaminooxidasehæmmere (MAO-hæmmere) (se pkt.
English: Danmark/Norge/Suomi/Finland/Sverige Zambon Sweden, Filial of Zambon Nederland B.V. Tlf/Puh/Tel: + 47 815 300 30
Danish: Danmark/Norge/Suomi/Finland/Sverige Zambon Sweden, Filial of Zambon Nederland B.V.