FrancophonIA/ELRC3.0 huggingface dataset:
English: In drug-drug-interaction studies in human, a weak interaction was observed with rosuvastatin (AUC increase between 1.25 and 2.00 fold) but no significant interaction was found with diclofenac.
Danish: I lægemiddelinteraktionsstudier hos mennesker observeredes en svag interaktion med rosuvastatin (stigning i AUC mellem 1,25 og 2,00 gange), men der blev ikke fundet nogen signifikant interaktion med diclofenac.
English: Skip the missed dose and take the next dose at the time you normally take it.
Danish: Spring den glemte dosis over, og tag den næste dosis på det tidspunkt, du normalt tager den.
English: Xadago may be taken with or without food.
Danish: Xadago kan tages med eller uden mad.
English: The lower dose of 50 mg/day is recommended for patients with moderate hepatic impairment.
Danish: Den lavere dosis på 50 mg/dag anbefales til patienter med moderat nedsat leverfunktion.
English: The relevant plasma concentrations of safinamide are substantially lower, therefore a clinically relevant interaction with co-administered substrates of these transporters is unlikely.
Danish: Safinamids relevante plasmakoncentrationer er betydeligt lavere, og det er derfor usandsynligt, at en interaktion med samtidigt administration af substrater af disse transportører vil have klinisk relevans.
English: Experience of use of safinamide in patients over 75 years of age is limited.
Danish: Der er begrænset erfaring med brug af safinamid hos patienter over 75 år.
English: Total clearance was determined to be 4.6 L/h classifying safinamide as a low clearance substance.
Danish: Total clearance blev bestemt til at være 4,6 l/t og klassificerer safinamid som en substans med lav clearance.
English: It acts to increase the level of a substance called dopamine in the brain, which is involved in the control of movement and is present in reduced amounts in the brain of patients with Parkinson's disease.
Danish: Det virker ved at øge niveauet af et stof kaldet dopamin i hjernen, som har med kontrol af bevægelser at gøre, og det er reduceret hos patienter med Parkinsons sygdom.
English: Safinamide exposure in patients with mild hepatic disease increased marginally (30% in AUC), while in patients with moderate hepatic impairment exposure increased by approximately 80% (see section
Danish: Safinamid-eksponering hos patienter med mild leversygdom steg marginalt (30 % i AUC), mens eksponering for patienter med moderat nedsat leverfunktion steg med cirka 80 % (se pkt.
English: In one patient suspected of consuming more than the daily prescribed dose of 100 mg for one month, symptoms of confusion, sleepiness, forgetfulness and dilated pupils were reported.
Danish: Hos en patient, der mistænkes for at have taget mere end den daglige ordinerede dosis på 100 mg i en måned, blev der indberettet symptomer på forvirring, søvnighed, glemsomhed og forstørrede pupiller.
English: Safinamide does not appear to significantly induce or inhibit enzymes at clinically relevant systemic concentrations.
Danish: Safinamid ser ikke ud til signifikant at inducere eller hæmme enzymer ved klinisk relevante systemiske koncentrationer.
English: - Uncontrollable jerky movements may occur or worsen when Xadago is used together with levodopa.
Danish: Ukontrollerbar rysten kan forekomme eller forværres, når Xadago tages sammen med levodopa.
English: Safinamide did not present genotoxic potential in in vivo and in several in vitro systems using bacteria or mammalian cells.
Danish: Safinamid viste ikke genotoksisk potentiale i in vivo og i adskillige in vitro-systemer med bakterier eller pattedyrceller.
English: Xadago is not recommended for use in children and adolescents, below 18 years old due to the lack of data on safety and efficacy in this population.
Danish: Xadago anbefales ikke til brug hos børn og unge under 18 år, da der ikke er nogen dokumentation for dets sikkerhed og virkning blandt denne population.
English: Impulse control disorders can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Danish: Der kan opstå impuls-kontrolforstyrrelser hos patienter, der behandles med dopamin-agonister og/eller dopaminerge behandlinger.
English: Safinamide is eliminated mainly in the urine.
Danish: Safinamid udskilles hovedsagelig i urinen.
English: The pharmacokinetics of safinamide are linear after single and repeated doses.
Danish: Safinamids farmakokinetiske profil er lineær efter enkle og gentagne doser.
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Amidase present in blood, plasma, serum, simulated gastric fluid and simulated intestinal fluid as well as human carboxylesterases hCE-1 and hCE-2 are not responsible for the biotransformation of safinamide to NW-1153.
Danish: Amidase i blod, plasma, serum, simulerede gastriske væsker, simulerede intestinale væsker samt humant carboxyleterase hCE-1 og hCE-2 er ikke ansvarlig for biotransformationen af safinamid til NW-1153.
English: Xadago is a medicine that contains the active substance safinamide.
Danish: Xadago er et lægemiddel, der indeholder det aktive stof safinamid.
English: In view of the selective and reversible MAO-B inhibitory activity of safinamide, antidepressants may be administered but used at the lowest doses necessary.
Danish: I betragtning af den selektive og reversible MAO-B-hæmmende aktivitet af safinamid, kan antidepressiva administreres, men bør anvendes ved den laveste nødvendige dosis.
English: PVC/PVDC/Aluminium blister packs of 14, 28, 30, 90 and 100 tablets.
Danish: Emballagetype og pakningsstørrelser PVC/PVDC/Aluminium blisterpakning med 14, 28, 30, 90 og 100 tabletter.
English: Safinamide may be taken with or without food.
Danish: Safinamid kan tages med eller uden mad.
English: Safinamide's metabolism is not dependent on Cytochrome P450 (CYP) based enzymes.
Danish: Safinamids metabolisme afhænger ikke af cytochrom P450 (CYP)baserede enzymer.
English: The recommended starting dose of Xadago is one 50 mg tablet that may be increased to one 100 mg tablet, taken once daily preferably in the morning by mouth with water.
Danish: Den sædvanlige startdosis Xadago er en 50 mg tablet, der muligvis kan øges til en 100 mg tablet, som tages via munden én gang om dagen, helst om morgenen, med vand.
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i /benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Safinamide acts through both dopaminergic and non-dopaminergic mechanisms of action.
Danish: Safinamid virker gennem både dopaminerge og ikke-dopaminerge virkningsmekanismer.
English: Elderly No change in dose is required for elderly patients.
Danish: Der kræves ingen dosisændring til ældre patienter.
English: Change LSM (SE)
Danish: LSM forandring (SE)
English: Safinamide used as an adjunct to levodopa may potentiate the side effects of levodopa, and preexisting dyskinesia may be exacerbated, requiring a decrease of levodopa.
Danish: Safinamid anvendt som et supplement til levodopa kan forstærke bivirkningerne ved levodopa, og præ-eksisterende dyskinesi kan forværres, hvilket kan kræve nedsættelse af levodopa.
English: A washout period corresponding to 5 half-lives of the SSRI used previously should be considered prior to initiating treatment with safinamide.
Danish: En udvaskningsperiode svarende til 5 halveringstider af tidligere anvend SSRI bør overvejes før opstart af behandling med safinamid.
English: Metabolite structure elucidation revealed three metabolic pathways of safinamide.
Danish: Klarlæggelse af metabolitstrukturer afslørede tre metaboliseringsveje for safinamid.
English: Toxic effects on the liver and accompanying symptoms as yellow/orange skin and skull, in pups exposed to safinamide during lactation are mediated mainly via in utero exposure, whereas exposure via the mother's milk had only a minor influence.
Danish: Toksiske effekter på leveren og ledsagende symptomer som gul/orange hud og kranium i unger udsat for safinamid under amning, er hovedsagelig medieret via in utero eksponering, men eksponering via modermælken har kun mindre betydning.
English: This potential increase is most likely of no clinical relevance as NW-1153, the first product in the metabolic pathway, is further transformed to secondary and tertiary metabolites.
Danish: Denne potentielle øgning er højst sandsynligt ikke klinisk relevant, da NW-1153, det første produkt i metaboliseringsvejen, omdannes yderligere til sekundære og tertiære metabolitter.
English: Both the SETTLE and 016/018 studies indicated significant superiority of safinamide, compared to placebo, at the target doses of 50 and 100 mg/day for the primary, and selected secondary, efficacy variables, as summarized in the table below.
Danish: Både SETTLE- og 016/018-studierne viste signifikant bedre resultater med safinamid sammenlignet med placebo, med måldosis på 50 og 100 mg/dag for den primære og de valgte sekundære virkningsvariable, som opsummeret i tabellen nedenfor.
English: Safinamide is a highly selective and reversible MAO-B inhibitor causing an increase in extracellular levels of dopamine in the striatum.
Danish: Safinamid er en højst selektiv og reversibel MAO-B-hæmmer, der forårsager en stigning i ekstracellulære niveauer af dopamin i striatum.
English: Phospholipidosis was seen mainly in the lungs in rodents (at exposures similar to humans) and monkeys (at exposures greater than 12 fold higher than human).
Danish: Phospholipider blev hovedsageligt set i lunger hos gnavere (ved en eksponering svarende til mennesker) og aber (ved en eksponering 12 gange højere end hos mennesker).
English: D-73614 Schorndorf Germany
Danish: D-73614 Schorndorf, Tyskland
English: Potential for retinal degeneration in patients with prior history of retinal disease
Danish: Risiko for nethindedegeneration hos patienter med tidligere nethindesygdom
English: (SETTLE) (24 weeks)
Danish: 27919 (SETTLE) (24 uger)
English: Safinamide absorption is rapid after single and multiple oral dosing, reaching Tmax in the time range 1.82.8 h after dosing under fasting conditions.
Danish: Safinamid absorption er hurtig efter enkelt eller multipel oral dosering og nåede tmax i tidsintervallet 1,8- 2,8 timer efter dosering under faste.
English: Safinamide must not be administered along with other MAO inhibitors (including moclobemide) as there may be a risk of non-selective MAO inhibition that may lead to a hypertensive crisis (see section 4.3).
Danish: Safinamid må ikke gives sammen med andre MAO-hæmmere (herunder moclobemid), da der kan være risiko for ikke-selektiv MAO-hæmning, der kan føre til en hypertensiv krise (se pkt.
English: In vitro experiments indicated that inhibition of amidases in human hepatocytes led to complete suppression of the NW-1153 formation.
Danish: In vitro-eksperimenter indikerer, at amidaser i humane hepatocytter førte til fuldstændig suppression af dannelsen af NW-1153.
English: Therefore, caution is necessary when safinamide is taken concomitantly with medicinal products that are OCT1 substrates and have a tmax similar to safinamide (2 hours) (e.g. metformin, aciclovir, ganciclovir) as exposure to these substrates might be increased as a consequence.
Danish: Derfor er forsigtighed nødvendig når safinamide indtages samtidig med lægemidler som er OTC1 substrater, og som har en tmax sammenlignelig med safinamide (2 timer) (f.eks. metformin, aciclovir, ganciclovir), da det kan øge eksponeringen for disse substrater.
English: You must wait at least 7 days after stopping Xadago treatment before starting treatment with MAO inhibitors or pethidine.
Danish: Du skal vente i mindst 7 dage efter at have stoppet behandling med Xadago før du starter behandling med MAO-hæmmere eller petidin.
English: Safinamide inhibits OCT1 in vitro at clinically relevant portal vein concentrations.
Danish: Safinamide hæmmer OCT1 in vitro ved klinisk relevante portal vene koncentrationer.
English: The tabulation below includes all adverse reactions in clinical trials where adverse reactions were considered related.
Danish: Nedenstående tabel inkluderer alle bivirkninger i kliniske studier, hvor bivirkningerne anses for at være relaterede.
English: In human liver microsomes (HLM), the N-dealkylation step appears to be catalysed by CYP3A4, as safinamide clearance in HLM was inhibited by ketoconazole by 90%.
Danish: I humane levermikrosomer (HLM) synes N-dealkyliseringstrinnet at blive katalyseret af CYP3A4, da safinamidclearance i HLM blev hæmmet 90 % af ketoconazol.
English: When safinamide is co-administered with products that are BCRP substrates, please refer to the SmPC for that particular medicinal product.
Danish: Når safinamid administreres samtidig med produkter, der er BCRP-substrater, henvises der til produktresuméet for det specifikke lægemiddel
English: Preliminary in vitro studies have shown that safinamide is not a substrate for the transporters P-gp, BCRP, OAT1B1, OAT1B3, OATP1A2 or OAT2P1.
Danish: Indledende in vitro-studier har påvist, at safinamid ikke er et substrat for transportørerne P-gp, BCRP, OAT1B1, OAT1B3, OATP1A2 eller OAT2P1.
English: Xadago is supplied in packs containing 14, 28, 30, 90 or 100 film coated tablets.
Danish: Xadago kommer i pakninger med 14, 28, 30, 90 eller 100 filmovertrukne tabletter.
English: Dedicated drug-drug interaction studies performed with ketoconazole, L-dopa and CYP1A2 and CYP3A4 substrates (caffeine and midazolam), did not detect any clinically significant effects on the pharmacokinetics of safinamide, or L-dopa, caffeine and midazolam.
Danish: Dedikerede lægemiddelinteraktionsstudier udført med ketoconazol, L-dopa og CYP1A2- og CYP3A4-substrater (koffein og midazolam), afslørede ingen klinisk signifikant effekt på farmakokinetikken af safinamid, eller L-dopa, koffein og midazolam.
English: (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.
Danish: (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.
English: These symptoms resolved on discontinuing the medicinal product, without sequelae.
Danish: Disse symptomer forsvandt ved seponering af lægemidlet, uden mén.
English: Caution should be exercised when initiating treatment with safinamide in patients with moderate hepatic impairment.
Danish: Der bør udvises forsigtighed, når behandling med safinamid initieres hos patienter med moderat nedsat leverfunktion.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of safinamide in milk (for details see 5.3).
Danish: Tilgængelige farmakodynamiske/toksikologiske data fra dyr har vist udskillelse af safinamid i mælk (se pkt.
English: No retinal degeneration was noted in monkeys despite higher systemic exposure than in rodents or in patients at the maximum human dose.
Danish: Der observeredes ingen nethindedegeneration hos aber trods højere systemisk eksponering end hos gnavere eller hos patienter med maksimal human dosis.
English: Safinamide is almost exclusively eliminated via metabolism, largely by high capacity amidases that have not yet been characterized.
Danish: Safinamid udskilles næsten udelukkende via metabolisering, overvejende af amidaser med høj kapacitet, som endnu ikke er karakteriseret.
English: The safety and efficacy of safinamide in children and adolescents under 18 years of age have not been established.
Danish: Safinamids sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: - Pethidine (a strong pain killer).
Danish: - Petidin (en stærk smertestillende medicin).
English: At concentrations of 50µM, safinamide inhibited OATP1A2 and OATP2P1.
Danish: Ved koncentrationer på 50µM hæmmede safinamid OATP1A2 og OATP2P1.
English: In general, safinamide may be used with selective serotonin re-uptake inhibitors (SSRIs) at the lowest effective dose, with caution for serotoninergic symptoms.
Danish: 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.
English: Animal studies indicate that safinamide treatment is associated with adverse reactions on female rat reproductive performance and sperm quality.
Danish: Dyrestudier viser, at behandling med safinamid er forbundet med bivirkninger på hunrotters reproduktive ydeevne og sædkvalitet.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Liver hypertrophy and fatty changes were seen only in rodent livers at exposures similar to humans.
Danish: Der blev kun observeret leverhypertrofi og ændringer i fedt i gnaveres lever ved eksponeringer svarende til mennesker.
English: 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).
Danish: 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.
English: Breast Feeding Xadago is likely to be excreted in breast milk.
Danish: Amning Xadago udskilles sandsynligvis i modermælk.
English: 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.
Danish: Hvis du lider af moderat nedsat leverfunktion, må du ikke tage mere end 50 mg om dagen.
English: Moderate or severe renal impairment did not alter the exposure to safinamide, compared to healthy subjects (see section 4.2).
Danish: Moderat eller svært nedsat nyrefunktion ændrede ikke eksponeringen for safinamid sammenlignet med raske forsøgspersoner (se pkt.
English: The ‘N-dealkylated acid' (NW-1689) undergoes conjugation with glucuronic acid yielding its acyl glucuronide.
Danish: ‘DenN-dealkylerede syre' (NW-1689) gennemgår konjugation med glucuronsyre og giver acylglukuronid.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: Hos mennesker elimineres safinamid næsten udelukkende via metabolisering (urinudskillelse af uforandret safinamid var <10 %) hovedsageligt formidlet gennem højkapacitet-amidase, som endnu ikke er karakteriseret.