FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms reported following overdose of Rasagiline ratiopharm included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).
Danish: Rapporterede symptomer efter en overdosering af Rasagilin ratiopharm omfattede let eufori (let form for mani), ekstremt højt blodtryk og serotoninsyndrom (se punkt 4).
English: Rasagiline ratiopharm contains the active substance rasagiline and it is used for the treatment of Parkinson's disease in adults.
Danish: Rasagilin ratiopharm indeholder det aktive stof rasagilin og anvendes til behandling af Parkinsons sygdom hos voksne.
English: 7 tablets 10 tablets 28 tablets 30 tablets 100 tablets 112 tablets 10 x 1 tablets 30 x 1 tablets 100 x 1 tablets
Danish: 7 tabletter 10 tabletter 28 tabletter 30 tabletter 100 tabletter 112 tabletter 10 x 1 tabletter 30 x 1 tabletter 100 x 1 tabletter
English: The mean volume of distribution following a single intravenous dose of rasagiline is 243 l. Plasma protein binding following a single oral dose of 14C-labelled rasagiline is approximately 60 to 70%.
Danish: Gennemsnitlig distributionsvolumen efter en enkelt intravenøs dosis rasagilin er 243 l. Plasmaproteinbindingen efter en enkelt peroral 14C-mærket dosis rasagilin er ca. 60-70%.
English: In patients experiencing somnolence/sudden sleep episodes, rasagiline may have major influence on the ability to drive and use machines.
Danish: Hos patienter, der oplever somnolens/episoder med pludseligt opstået søvn, kan rasagilin i væsentlig grad påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: One case of hypersexuality was reported in monotherapy placebo-controlled study.
Danish: Der er rapporteret om et tilfælde af hyperseksualitet i monoterapi i et placebokontrolleret studie.
English: If you stop taking Rasagiline ratiopharm Do not stop taking Rasagiline ratiopharm without first talking to your doctor.
Danish: Hvis De holder op med at tage Rasagilin ratiopharm Hold ikke op med at tage Rasagilin ratiopharm uden først at have talt med Deres læge om det.
English: Rasagiline ratiopharm helps to increase and sustain levels of dopamine in the brain.
Danish: Rasagilin ratiopharm er med til at øge og opretholde dopaminniveauet i hjernen.
English: *See section description of selected adverse reactions
Danish: * Se punktet med beskrivelse af udvalgte bivirkninger
English: Agents that affect CYP1A2 activity
Danish: Midler, der indvirker på CYP1A2-aktivitet
English: Although many of these patients reported somnolence while on rasagiline with other dopaminergic medicinal products, some perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event.
Danish: Selvom mange af disse patienter rapporterede om somnolens, mens de var i behandling med rasagilin sammen med andre lægemidler med dopaminerg virkning, bemærkede nogle, at de ikke fik forvarsler, som f.eks. ekstrem døsighed og var af den opfattelse, at de var opmærksomme før hændelsen.
English: For further information please refer to section driving and using machines.
Danish: Se yderligere oplysninger i punktet om at føre motorkøretøj og betjene maskiner.
English: Age has little influence on rasagiline pharmacokinetics in the elderly (> 65 years) (see section 4.2)
Danish: Alder har kun ringe virkning på farmakokinetikken hos ældre patienter (> 65 år) (se pkt.
English: Do not use this medicine after the expiry date which is stated on the carton, bottle or blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken, beholderen eller blisterpakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Excessive daily sleepiness (hypersomnia, lethargy, sedation, sleep attacks, somnolence, sudden onset of sleep) can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Danish: Ekstrem daglig søvnighed (hypersomni, letargi, sedation, søvnanfald, somnolens, pludselig opstået søvn) kan forekomme hos patienter i behandling med dopaminagonister og/eller anden behandling med dopaminerg virkning.
English: - Elevated blood pressure - Excessive drowsiness - Sudden onset of sleep
Danish: - Forhøjet blodtryk - Overdreven døsighed - Pludselig indsovning
English: If you take more Rasagiline ratiopharm than you should If you think that you may have taken too many Rasagiline ratiopharm tablets, contact your doctor or pharmacist immediately.
Danish: Hvis De har taget for meget Rasagilin ratiopharm Hvis De mener, at De har taget for mange Rasagilin ratiopharm tabletter, skal De straks kontakte Deres læge eller apotekspersonalet.
English: Since rasagiline potentiates the effects of levodopa, the adverse reactions of levodopa may be increased and pre-existing dyskinesia exacerbated.
Danish: Eftersom rasagilin forstærker virkningen af levodopa, kan levodopas bivirkninger øges og allerede eksisterende dyskinesi forværres.
English: Rasagiline ratiopharm may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson's disease).
Danish: Rasagilin ratiopharm kan forårsage døsighed, og at du pludselig falder i søvn under daglige aktiviteter, især hvis du tager andre dopaminerge lægemidler (anvendes til behandling af Parkinsons sygdom).
English: There is no relevant use of Rasagiline ratiopharm in children and adolescents.
Danish: Der er ingen relevant brug af Rasagilin ratiopharm til børn og unge.
English: Rasagiline was not carcinogenic in rats at systemic exposure, 84 - 339 times the expected plasma exposures in humans at 1 mg/day.
Danish: Rasagilin var ikke carcinogen i rotter ved systemisk koncentration, som var 84-339 gange højere end det forventede plasmaniveau hos mennesker, som får 1 mg/dagligt.
English: The recommended dose of rasagiline is 1 mg (one tablet of Rasagiline ratiopharm) once daily, to be taken with or without levodopa.
Danish: Den anbefalede dosis rasagilin er 1 mg (en tablet Rasagilin ratiopharm) én gang dagligt til indtagelse med eller uden levodopa.
English: Aluminium/aluminium blister packs of 7, 10, 28, 30, 100 or 112 tablets.
Danish: Aluminium/aluminiumblisterpakninger med 7, 10, 28, 30, 100 eller 112 tabletter.
English: Patients being treated with rasagiline and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until they have gained sufficient experience with rasagiline and other dopaminergic medications to gauge whether or not it affects their mental and/or motor performance adversely.
Danish: Patienter, der behandles med rasagilin og udviser somnolens og/eller episoder med pludselig opstået søvn, skal undlade at føre motorkøretøj eller foretage aktiviteter, hvor nedsat årvågenhed kan udsætte dem selv eller andre for risiko for alvorlige kvæstelser eller død (f.eks. betjening af maskiner), indtil de har opnået tilstrækkelig erfaring med rasagilin og andre dopaminerge lægemidler til at vurdere, om lægemidlerne forringer deres mentale og/eller motoriske funktionsevne.
English: The efficacy of rasagiline was established in three studies: as monotherapy treatment in study I and as adjunct therapy to levodopa in the studies II and III.
Danish: Rasagilins virkning blev påvist i tre undersøgelser: som monoterapi i undersøgelse I og som kombinationsbehandling med levodopa i undersøgelse II og III.
English: In mice, increased incidences of combined bronchiolar/alveolar adenoma and/or carcinoma were observed at systemic exposures, 144 - 213 times the expected plasma exposure in humans at 1 mg/day.
Danish: Hos mus sås et øget antal tilfælde af kombinerede bronchiolære/alveolære adenomer og/eller carcinomer ved systemisk koncentration, som var 144-213 gange højere end det forventede plasmaniveau hos mennesker, som får 1 mg/dagligt.
English: Rasagiline ratiopharm is indicated in adults for the treatment of idiopathic Parkinson's disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Danish: Rasagilin ratiopharm er indiceret hos voksne ved behandling af idiopatisk Parkinsons sygdom som monoterapi (uden levodopa) eller som kombinationsbehandling (med levodopa) hos patienter med end-of-dose fluktuationer.
English: No human data on the effect of rasagiline on fertility are available.
Danish: Der foreligger ingen humane data om virkningen af rasagilin på fertiliteten.
English: No special precautions are required in patients with renal impairment.
Danish: Der er ingen særlige forholdsregler for patienter med nedsat nyrefunktion.
English: Rasagiline's pharmacokinetics characteristics in subjects with mild (CLcr 50-80 ml/min) and moderate (CLcr 30-49 ml/min) renal impairment were similar to healthy subjects.
Danish: Rasagilins farmakokinetiske egenskaber hos forsøgspersoner med let (CLcr 50-80 ml/min) og moderat (CLcr 30-49 ml/min) nedsat nyrefunktion var de samme, som sås hos raske forsøgspersoner.
English: Musculoskeletal pain,
Danish: Muskuloskeletale smerter
English: These results indicate that rasagiline's therapeutic concentrations are unlikely to cause any clinically significant interference with substrates of these enzymes (see section 5.3).
Danish: Disse resultater tyder på, at terapeutiske koncentrationer af rasagilin sandsynligvis ikke giver anledning til klinisk relevant påvirkning af substrater for disse enzymer (se pkt.
English: Patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that rasagiline does not affect them adversely.
Danish: Patienter bør tilrådes forsigtighed ved betjening af maskiner, herunder også bilkørsel eller motorcykelkørsel, indtil de er forholdsvis sikre på, at rasagilin ikke påvirker dem ugunstigt.
English: Ex vivo and in vitro experiments demonstrate that rasagiline is neither inhibitor nor inducer of major CYP450 enzymes (see section 4.5).
Danish: Studier ex vivo og in vitro påviser, at rasagilin hverken er hæmmer eller induktor af vigtige CYP450-enzymer (se pkt.
English: If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking Rasagiline ratiopharm do not drive or operate machinery (see section 2).
Danish: Hvis De har oplevet søvnighed og/eller episoder med pludseligt opstået søvn før, eller mens De tager Rasagilin ratiopharm, skal De undlade at køre bil eller betjene maskiner (se punkt 2).
English: Cerebrovascular accident
Danish: Cerebrovaskulært tilfælde
English: Do not store above 30oC.
Danish: Må ikke opbevares ved temperaturer over 30 oC.
English: White to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.
Danish: Hvide til grålighvide, runde, flade tabletter med skrå kant præget på den ene side med ”GIL” og nedenunder ”1” og uden præg på den anden side.
English: Incidence of skin melanoma in placebo-controlled clinical studies was 2/380 (0.5%) in rasagiline 1 mg as adjacent to levodopa therapy group vs. 1/388 (0.3%) incidence in placebo group.
Danish: Incidensen af hudmelanom i placebokontrollerede kliniske studier var 2/380 (0,5 %) i gruppen, der blev behandlet med 1 mg rasagalin i kombination med levodopa vs. incidensen på 1/388 (0,3 %) i placebogruppen.
English: Patients should be cautioned about possible additive effects of sedating medicinal products, alcohol, or other central nervous system depressants (e.g. benzodiazepines, antipsychotics, antidepressants) in combination with rasagiline, or when taking concomitant medications that increase plasma levels of rasagiline (e.g. ciprofloxacin) (see section 4.4).
Danish: Patienterne skal advares om mulige additive effekter af sederende lægemidler, alkohol eller andre sedativer, der indvirker på centralnervesystemet (f.eks. benzodiazepiner, antipsykotika, antidepressiva) i kombination med rasagilin, eller om samtidig indgift af lægemidler, der øger rasagilins plasmakoncentration (f.eks. ciprofloxacin) (se pkt.
English: Talk to your doctor before taking Rasagiline ratiopharm - If you have any liver problems - You should speak with your doctor about any suspicious skin changes.
Danish: Kontakt lægen, før De tager Rasagilin ratiopharm - hvis De har leverproblemer - hvis De får mistænkelige hudforandringer, skal De tale med Deres læge
English: Pregelatinised maize starch Colloidal anhydrous silica Stearic acid
Danish: Prægelatineret majsstivelse Kolloid vandfri silica Stearinsyre
English: ICDs can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Danish: Impulskontrolforstyrrelser kan forekomme hos patienter i behandling med dopaminagonister og/eller anden behandling med dopaminerg virkning.
English: Cases of patients, treated with rasagiline and other dopaminergic medicinal products, falling asleep while engaged in activities of daily living have been reported.
Danish: Der er rapporteret om tilfælde med patienter, der blev behandlet med rasagilin og andre lægemidler med dopaminerg virkning, der faldt i søvn, mens de udførte daglige aktiviteter.
English: You may need urgent medical advice or treatment: - If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).
Danish: De kan have behov for akut lægehjælp eller -behandling: - Hvis De udvikler usædvanlig adfærd som f.eks. tvangshandlinger, tvangstanker, ludomani, uhæmmet, umådeholdent indkøb eller forbrug, impulshandlinger og en unormalt stor sexlyst eller en stigning i seksuelle tanker (impulskontrolforstyrrelser) (se punkt 2).
English: The following were reported during post-marketing exposure with unknown frequency: compulsions, compulsive shopping, dermatillomania, dopamine dysregulation syndrome, impulse-control disorder, impulsive behaviour, kleptomania, theft, obsessive thoughts, obsessive-compulsive disorder, stereotypy, gambling, pathological gambling, libido increased, hypersexuality, psychosexual disorder, sexually inappropriate behaviour.
Danish: Følgende blev rapporteret efter markedsføringen med ukendt hyppighed: tvangshandlinger, overdrevent indkøbsmønster, dermatillomani, dopamin-dysreguleringssyndrom, impulskontrolforstyrrelser, impulsiv adfærd, kleptomani, tyveri, tvangstanker, obsessiv-kompulsiv tilstand, stereotypi, gambling, ludomani, øget libido, hyperseksualitet, psykoseksuel lidelse, upassende seksuel adfærd.
English: Decreasing the dose of levodopa may ameliorate this adverse reaction.
Danish: Dosisreduktion af levodopa kan reducere denne bivirkning.
English: In the post-marketing period, cases of potentially life-threating serotonin syndrome associated with agitation, confusion, rigidity, pyrexia and myoclonus have been reported by patients treated with antidepressants, meperidine, tramadol, methadone, or propoxyphene concomitantly with rasagiline.
Danish: Efter markedsføringen er der rapporteret om tilfælde af potentielt livstruende serotoninsyndrom, som forbindes med agitation, forvirring, rigiditet, pyreksi og myoklonus af patienter, der var i behandling med antidepressiva, meperidin, tramadol, methadon eller propoxyphen samtidig med rasagilin.
English: Non-clinical data indicate that rasagiline has no effect on fertility.
Danish: Prækliniske data indikerer, at rasagilin ikke har nogen virkning på fertiliteten.
English: Take the Rasagiline ratiopharm carton/ blister or bottle with you to show the doctor or pharmacist.
Danish: Medbring Rasagilin ratiopharm æsken/blisterpakningen eller beholderen, når De opsøger Deres læge/skadestue eller apotekspersonalet.
English: Results of five tyramine challenge studies (in volunteers and Parkinson's disease patients), together with results of home monitoring of blood pressure after meals (of 464 patients treated with 0.5 or 1 mg/day of rasagiline or placebo as adjunct therapy to levodopa for six months without tyramine restrictions), and the fact that there were no reports of tyramine/rasagiline interaction in clinical studies conducted without tyramine restriction, indicate that rasagiline can be used safely without dietary tyramine restrictions.
Danish: Resultater fra fem undersøgelser, hvor raske frivillige og patienter med Parkinsons sygdom fik en testdosis af tyramin, og resultaterne af hjemmeblodtryksmåling efter måltider (med 464 patienter i behandling med 0,5 eller 1 mg rasagilin dagligt eller placebo i kombinationsbehandling med levodopa i seks måneder uden restriktioner i patienternes tyraminindtagelse) samt det faktum, at der ikke sås tyramin/rasagilin-interaktion i kliniske undersøgelser gennemført uden restriktioner i tyraminindtagelse, indikerer, at det er sikkert at tage rasagilin uden at begrænse indtagelsen af tyramin i kosten.
English: - The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid, talc.
Danish: - Øvrige indholdsstoffer: Mannitol, kolloid vandfri silica, majsstivelse, prægelatineret majsstivelse, stearinsyre, talkum.
English: Very common Common
Danish: Systemorganklasse Meget almindelig Almindelig
English: In post-marketing experience, these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.
Danish: Efter markedsføring er disse symptomer også set hos patienter i behandling med rasagilin for Parkinsons syge.
English: Levodopa and other Parkinson's disease medicinal products In Parkinson's disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Danish: Levodopa og andre lægemidler mod Parkinsons sygdom Hos patienter med Parkinsons sygdom, der fik rasagilin i kombination med vedvarende behandling med levodopa sås ingen klinisk signifikant virkning af levodopa-behandlingen på rasagilin clearance.
English: The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets, in perforated unit dose blister packs of 10 x 1, 30 x 1 and 100 x 1 tablets or in a bottle containing 30 tablets.
Danish: Tabletterne findes i blisterpakninger med 7, 10, 28, 30, 100 og 112 tabletter, i perforerede enkeltdosisblisterpakninger med 10 x 1, 30 x 1 og 100 x 1 tabletter eller i en beholder med 30 tabletter.
English: Rasagiline clinical trials did not allow concomitant use of fluoxetine or fluvoxamine with rasagiline, but the following antidepressants and doses were allowed in the rasagiline trials: amitriptyline ≤ 50 mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100 mg/daily, and paroxetine ≤ 30 mg/daily (see section 4.5).
Danish: I de kliniske undersøgelser med rasagilin var samtidig brug af fluoxetin eller fluvoxamin ikke tilladt, men det var tilladt at anvende følgende antidepressiva og doser: amitriptylin ≤ 50 mg dagligt, trazodon ≤ 100 mg dagligt, citalopram ≤ 20 mg dagligt, sertralin ≤ 100 mg dagligt og paroxetin ≤ 30 mg dagligt (se pkt.
English: CYP1A2 inducers
Danish: CYP1A2-induktorer
English: The difference between the mean change from baseline to week 26/termination (LOCF, Last Observation Carried Forward) was statistically significant (UPDRS, parts I-III: for rasagiline 1 mg compared to placebo -4.2, 95% CI [-5.7, -2.7]; p<0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p<0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p<0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
Danish: (UPDRS, del I-III: forskellen mellem rasagilin 1 mg sammenlignet med placebo var 4,2, 95% CI [5,7; 2,7]; p<0,0001; forskellen mellem rasagilin 2 mg sammenlignet med placebo var 3,6, 95% CI [5,0; 2,1]; p<0,0001, UPDRS Motor, del II: forskellen mellem rasagilin 1 mg sammenlignet med placebo var 2,7; 95% CI [3,87; 1,55], p<0,0001; forskellen mellem rasagilin 2 mg sammenlignet med placebo var 1,68; 95% CI [2,85; 0,51], p=0,0050).
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer
English: No change in dose is required for elderly patients (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines (see section 4.7).
Danish: Patienter, som har oplevet somnolens og/eller en episode med pludselig opstået søvn, skal undlade at føre motorkøretøj eller betjene maskiner (se pkt.
English: Orthostatic hypotension*
Danish: Ortostatisk hypotension*
English: In blinded placebo-controlled studies (monotherapy and adjunct) severe hypertension was not reported in any subjects in the rasagiline arm.
Danish: I blindede placebokontrollerede studier (mono- og kombinationsterapi) blev der ikke rapporteret om alvorlig ortostatisk hypotension hos nogen forsøgspersoner i rasagilin-armen.
English: Rasagiline is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Rasagilin er kontraindiceret til patienter med alvorligt nedsat leverfunktion (se pkt.
English: Concomitant use of rasagiline and levodopa
Danish: Samtidig behandling med rasagilin og levodopa
English: A similar pattern of excessive daily sleepiness has been reported post-marketing with rasagiline.
Danish: Der er rapporteret om et lignende mønster med ekstrem daglig søvnighed med rasagilin efter markedsføringen.
English: Do not take Rasagiline ratiopharm - If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Rasagilin ratiopharm - hvis De er allergisk over for rasagilin eller et af de øvrige indholdsstoffer i dette lægemiddel
English: The safety and efficacy of Rasagiline ratiopharm in children and adolescents have not been established.
Danish: Rasagilin ratiopharms sikkerhed og virkning hos børn og unge er ikke klarlagt.
English: Other medicines and Rasagiline ratiopharm Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Rasagilin ratiopharm Fortæl det altid til lægen eller apotekspersonalet, hvis De bruger anden medicin eller har brugt det for nylig.
English: In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain as back and neck pain, and arthralgia in both regimens.
Danish: I kliniske studier af patienter med Parkinsons sygdom var de hyppigst rapporterede bivirkninger: hovedpine, depression, vertigo og influenza (influenza og rhinitis) i monoterapi; dyskinesi, ortostatisk hypotension, fald, mavesmerter, kvalme og opkastning samt tør mund ved supplerende behandling med levodopa; smerter i knogler, led og muskler som ryg- og halssmerter og artralgi i begge regimener.
English: In subjects with mild hepatic impairment, AUC and Cmax were increased by 80% and 38%, respectively.
Danish: Hos forsøgspersoner med let nedsat leverfunktion blev AUC og Cmax øget med hhv. 80% og 38%.
English: Non-clinical data indicate that rasagiline inhibits prolactin secretion and thus, may inhibit lactation.
Danish: Prækliniske data indikerer, at rasagilin hæmmer prolaktinsekretionen og derfor kan hæmme mælkedannelsen.
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest ændret måned/ÅÅÅÅ.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/977/001-010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/977/001-010
English: Pethidine
Danish: Pethidin