FrancophonIA/ELRC3.0 huggingface dataset:
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Danish: Der er indberettet tilfælde af selvmordstanker og -adfærd hos patienter, som er behandlet med antiepileptika i forbindelse med en række indikationer.
English: White, slightly viscous suspension.
Danish: Hvid, let viskøs suspension.
English: Inovelon tablets must be taken twice daily with water, in the morning and in the evening.
Danish: Inovelon-tabletter skal tages to gange dagligt sammen med vand, om morgenen og om aftenen.
English: In addition, the study investigated the cognitive development, behaviour and language development of subjects treated with rufinamide compared to subjects receiving any-other-AED.
Danish: Desuden undersøgte studiet den kognitive udvikling, adfærd og sprogudvikling hos forsøgspersoner behandlet med rufinamid, sammenlignet med forsøgspersoner, der fik andre antiepileptika.
English: Alternatively, use the score line to break the tablet into two equal halves.
Danish: Alternativt kan delekærven bruges til at brække tabletten i to lige store halvdele.
English: Tell the doctor if you are taking the blood thinner - warfarin.
Danish: Fortæl lægen, hvis du tager det blodfortyndende middel warfarin.
English: Regarding the immunotoxic potential, small thymus and thymic involution were observed in dogs in a 13-week study with significant response at the high dose in male.
Danish: Med hensyn til immunotoksisk potentiale blev små thymi og thymusinvolution set hos hunde i et studie af 13 ugers varighed med signifikant respons ved den høje dosis hos handyr.
English: The film-coating consists of hypromellose, macrogols (8000), titanium dioxide (E171), talc and ferric oxide red (E172).
Danish: Filmovertrækket består af hypromellose, macrogol (8000), titandioxid (E171), talcum og rød jernoxid (E172).
English: When given twice daily at 12-hourly intervals, rufinamide accumulates to the extent predicted by its terminal half-life, indicating that the pharmacokinetics of rufinamide are time-independent (i.e. no autoinduction of metabolism).
Danish: Ved administration to gange dagligt med 12 timers intervaller, akkumuleres rufinamid i det omfang, der forudses ud fra dets terminale halveringstid, hvilket tyder på, at rufinamids farmakokinetik er tidsuafhængig (dvs. ingen autoinduktion af metabolismen).
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Danish: Patienter (og deres omsorgsgivere) bør gøres opmærksom på behovet for at søge lægehjælp, hvis der viser sig tegn på selvmordstanker eller -adfærd.
English: If you stop taking Inovelon
Danish: Hvis du holder op med at tage Inovelon
English: The antiepileptic drug (AED) hypersensitivity syndrome occurred in close temporal association to the initiation of rufinamide therapy and in the paediatric population.
Danish: Antiepileptikum-overfølsomhedssyndrom forekom i tæt tidsmæssig forbindelse med indledningen af rufinamidbehandling og i den pædiatriske population.
English: Treatment should be supportive and may include haemodialysis (see section 5.2).
Danish: Behandlingen bør være understøttende og kan omfatte hæmodialyse (se pkt.
English: A total of 12 patients received any-other AED at the investigator's discretion in the control arm.
Danish: I alt 12 patienter fik andre antiepileptika efter investigatorens skøn i kontrolarmen.
English: Depending on the individual sensitivity, rufinamide may have a minor to major influence on the ability to drive and use machines.
Danish: Afhængig af den individuelle følsomhed kan rufinamid påvirke evnen til at føre motorkøretøj og betjene maskiner i mindre til moderat grad.
English: After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
Danish: Efter en akut overdosis kan maven tømmes ved ventrikelskylning eller ved at fremkalde opkastning.
English: Common (more than 1 in a 100 patients) side effects of Inovelon are:
Danish: Almindelige (mere end 1 ud af 100 patienter) bivirkninger af Inovelon er:
English: The bioavailability of rufinamide is dependent on dose.
Danish: Rufinamids biotilgængelighed er dosisafhængig.
English: Due to the potential harmful effects for the breast-fed infant, breast-feeding should be avoided during maternal treatment with rufinamide.
Danish: På grund af de potentielt skadelige virkninger for det ammede barn, bør amningen undgås, så længe moderen er i behandling med rufinamid.
English: In this study, 25 patients were exposed to rufinamide as adjunctive therapy for 24 weeks at a dose of up to 45 mg/kg/day, in 2 divided doses.
Danish: I dette studie blev 25 patienter eksponeret over for rufinamid som tillægsbehandling i 24 uger ved en dosis på op til 45 mg/kg/dag, i 2 delte doser.
English: Studies in new-born infants or infants and toddlers under 1 year of age have not been conducted.
Danish: Der er ikke udført studier hos nyfødte eller spædbørn og børn under 1 år.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral suspension contains 40 mg rufinamide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml oral suspension indeholder 40 mg rufinamid.
English: Pneumonia Influenza Nasopharyngitis Ear infection Sinusitis
Danish: Pneumoni Influenza Nasopharyngitis Øreinfektion Sinuitis
English: Gait disturbance*
Danish: Gangforstyrrelser*
English: Rufinamide has demonstrated little or no significant capacity in -vitro to act as a competitive or mechanism-based inhibitor of the following human P450 enzymes: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 or CYP4A9/11-2.
Danish: Rufinamid har udvist lille eller ikke signifikant evne in -vitro til at virke som en kompetitiv eller mekanismebaseret hæmmer af følgende humane P450 enzymer: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 eller CYP4A9/11-2.
English: It is recommended that patients treated with substances that are metabolised by the CYP3A4 enzyme system are to be carefully monitored for two weeks at the start of, or after the end of treatment with rufinamide, or after any marked change in the dose.
Danish: Det anbefales, at patienter, der behandles med stoffer, som metaboliseres af CYP3A, monitoreres omhyggeligt i 2 uger ved starten eller efter afslutningen af behandlingen med rufinamid, eller efter enhver markant dosisændring.
English: If you are a woman of childbearing age, you must use contraceptive measures while taking Inovelon.
Danish: Hvis du er en kvinde i den fødedygtige alder, skal du anvende svangerskabsforebyggende midler, mens du tager Inovelon.
English: The pharmacokinetics of a single 400 mg dose of rufinamide were not altered in subjects with chronic and severe renal failure compared to healthy volunteers.
Danish: Farmakokinetikken af en enkelt dosis på 400 mg rufinamid var uændret hos patienter med kronisk og alvorligt nedsat nyrefunktion sammenlignet med raske forsøgspersoner.
English: Rufinamide is metabolised by hydrolysis, and is not metabolised to any notable degree by cytochrome P450 enzymes.
Danish: Rufinamid metaboliseres ved hydrolyse og metaboliseres ikke i nævneværdig grad af cytokrom P450 enzymer.
English: *Cross reference to section 4.4.
Danish: *Krydsreference til pkt.
English: Adverse reactions reported with an incidence greater than placebo, during the Lennox-Gastaut syndrome double-blind studies or in the overall rufinamide-exposed population, are listed in the table below by MedDRA preferred term, system organ class and by frequency.
Danish: De bivirkninger, der blev rapporteret med en hyppighed større end placebo under de dobbeltblinde studier med Lennox-Gastaut-syndrom eller i den samlede rufinamideksponerede population, er opført i nedenstående tabel i henhold til MedDRA-konventionen, systemorganklasse og hyppighed.
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlings-ko mplikationer
English: Environmental risk assessment studies have shown that rufinamide is very persistent in the environment (see section 6.6).
Danish: Miljørisikovurderingsstudier har vist, at rufinamid ikke nedbrydes ekstremt langsomt i miljøet (se pkt.
English: The Least Square mean change of the Child Behaviour Checklist (CBCL) Total Problems score after 2 years of treatment were 53.75 for the any other AED group and 56.35 for the rufinamide group (LS mean difference [95% CI] +2.60 [-10.5,15.7]; p=0.6928), and the difference between treatments was -2.776 (95% CI: -13.3, 7.8, p=0.5939).
Danish: Ændringer ved mindste kvadraters gennemsnit af Child Behaviour Checklist (CBCL) Total Problems-score efter 2 års behandling var 53,75 for gruppen med andre antiepileptika, og 56,35 for rufinamid gruppen (forskel i mindste kvadraters gennemsnit [95 % CI] +2,60 [-10,5;15,7], p=0,6928), og forskellen mellem behandlingerne var -2,776 (95 % CI: -13,3; 7,8, p=0,5939).
English: Potential for other medicinal products to affect rufinamide
Danish: Mulighed for at andre lægemidler påvirker rufinamid
English: A small number of people being treated with antiepileptics such as Inovelon have had thoughts of harming or killing themselves.
Danish: Et lille antal personer, som behandles med antiepileptika såsom Inovelon har overvejet selvbeskadigende adfærd/haft selvmordstanker.
English: The safety and efficacy of rufinamide in new-born infants or infants and toddlers aged less than 1 year have not been established.
Danish: Rufinamids sikkerhed og virkning hos nyfødte eller spædbørn og små børn i alderen under 1 år er ikke klarlagt.
English: An adverse effect not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to human use, was myelofibrosis of the bone marrow in the mouse carcinogenicity study.
Danish: En bivirkning, som ikke blev observeret i kliniske undersøgelser, men som blev set hos dyr ved en eksponering, der svarede til klinisk eksponering, og som havde mulig relevans for mennesker, var myelofibrose af knoglemarv i karcinogenicitetsstudie med mus.
English: Each carton contains one bottle, two identical calibrated oral dosing syringes and a press-in-bottle adapter (PIBA).
Danish: Hver æske indeholder en flaske, to identiske kalibrerede orale doseringssprøjter og en press-in-bottle adapter (PIBA).
English: Co-administration of rufinamide 800 mg twice daily and a combined oral contraceptive (ethinyloestradiol 35 μg and norethindrone 1 mg) for 14 days resulted in a mean decrease in the ethinyl estradiol AUC0-24 of 22% and in norethindrone AUC0-24 of 14%.
Danish: Samtidig administration af rufinamid 800 mg to gange dagligt og kombineret oral antikonception (ethinylestradiol 35 μg og norethindron 1 mg) i 14 dage medførte et gennemsnitligt fald i ethinylestradiols AUC024 på 22 % og for norethindrons AUC024 på 14 %.
English: Furthermore, rufinamide does not inhibit the activity of cytochrome P450 enzymes (see section 5.2).
Danish: Desuden hæmmer rufinamid ikke aktiviteten af cytokrom P450 enzymer (se pkt.
English: Rufinamide has been shown to induce the cytochrome P450 enzyme CYP3A4 and may therefore reduce the plasma concentrations of substances which are metabolised by this enzyme.
Danish: Det er blevet vist, at rufinamid inducerer CYP3A4 Rufinamid kan derfor reducere plasmakoncentrationerne af stoffer, der metaboliseres af dette enzym.
English: The suspension should be taken twice daily in the morning and in the evening, in two equally divided doses.
Danish: Suspensionen bør indtages to gange dagligt, om morgenen og om aftenen, delt i to lige store doser.
English: Propylene glycol (E1520).
Danish: Propylenglycol (E1520).
English: Inovelon contains lactose
Danish: Inovelon indeholder lactose
English: The mean CYP3A4 activity, assessed as clearance of triazolam, was increased by 55% after 11 days of treatment with rufinamide 400 mg twice daily.
Danish: Middelaktiviteten af CYP3A4, vurderet som triazolamclearance, blev forøget med 55 % efter 11 dages behandling med rufinamid 400 mg to gange dagligt.
English: Talk to your doctor or pharmacist if:
Danish: Kontakt lægen eller på apoteket:
English: In clinical studies discontinuation was achieved by reducing the dose by approximately 25% every two days.
Danish: I kliniske studier gennemførtes seponering ved at reducere dosis med ca. 25 % hver anden dag.
English: Aluminium/aluminium blisters, packs of 10, 30, 50, 60 and 100 film-coated tablets.
Danish: Aluminium/aluminium blister, pakninger med 10, 30, 50, 60 og 100 filmovertrukne tabletter.
English: The prescribed dose of Inovelon oral suspension can be administered via an enteral feeding tube.
Danish: Den foreskrevne dosis af Inovelon oral suspension kan indgives via enteral sonde.
English: Toxicities observed in dogs at levels similar to human exposure at the maximum recommended dose were liver changes, including bile thrombi, cholestasis and liver enzyme elevations thought to be related to increased bile secretion in this species.
Danish: De toksiske virkninger, der blev observeret hos hunde ved koncentrationer svarende til human eksponering ved den maksimalt anbefalede dosering, bestod i leverforandringer, herunder galdetromber, kolestase og leverenzymstigning, der anses for at være relateret til øget galdesekretion hos denne dyreart.
English: 1 bottle of 460 ml contains 18400 mg rufinamide.
Danish: 1 flaske med 460 ml indeholder 18.400 mg rufinamid.
English: Inovelon contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Inovelon indeholder lactose og bør derfor ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: If you forget to take Inovelon
Danish: Hvis du har glemt at tage Inovelon
English: Rufinamide concentrations are not subject to clinically relevant changes on co-administration with known enzyme inducing antiepileptic medicinal products.
Danish: Rufinamidkoncentrationen er ikke underlagt klinisk relevante ændringer ved indgivelse samtidig med kendte enzyminducerende antiepileptika.
English: In addition, patients have experienced: anxiety, insomnia, nose bleeds, acne, rash, back pain, infrequent periods, bruising, head injury (as a result of accidental injury during a seizure).
Danish: Herudover har patienter oplevet: Angst, søvnløshed, næseblod, akne, udslæt, rygsmerter, uregelmæssig menstruation, blå mærker, beskadigelse af hovedet (som følge af kvæstelser under et anfald).
English: Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older.
Danish: Inovelon er indiceret til supplerende behandling af anfald (epileptiske), som er associeret med Lennox-Gastaut-syndrom (LGS) hos patienter på 1 år og ældre.
English: Adults, adolescents and children weighing 30 kg or over
Danish: Voksne, unge og børn, der vejer 30 kg eller derover
English: However, plasma levels were reduced by approximately 30% when haemodialysis was applied after administration of rufinamide, suggesting that this may be a useful procedure in case of overdose (see sections 4.2 and 4.9).
Danish: Plasmakoncentrationen blev imidlertid reduceret med ca. 30 %, når der blev udført hæmodialyse efter indgivelse af rufinamid, hvilket tyder på, at dette kan være en brugbar procedure i tilfælde af overdosering (se pkt.
English: To ensure adequate dosing, after administration of the oral suspension, the enteral feeding tube must be flushed at least once with 1 ml of water.
Danish: For at sikre korrekt dosering skal den enterale sonde skylles mindst én gang med 1 ml vand efter indgivelse af den orale suspension.
English: Detailed information on this product is available on the European Medicines Agency website http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Potential for rufinamide to affect other medicinal products
Danish: Mulighed for at rufinamid påvirker andre lægemidler
English: Inovelon contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) These ingredients may cause allergic reactions (possibly delayed).
Danish: Inovelon indeholder methylparahydroxybenzoat (E218) og propylparahydroxybenzoat (E216): Disse indholdsstoffer kan forårsage allergiske reaktioner (kan optræde efter behandlingen).
English: Doses of up to 3,600 mg/day have been studied in a limited number of patients.
Danish: Doser på op til 3.600 mg/dag er blevet undersøgt hos et begrænset antal patienter.
English: A study in patients with severe renal impairment indicated that no dose adjustments are required for these patients (see section 5.2).
Danish: Et studie hos patienter med alvorligt nedsat nyrefunktion indikerede, at der ikke kræves dosisjustering hos disse patienter (se pkt.
English: Additionally, Inovelon (rufinamide oral suspension) was administered in a multicentre, open-label study comparing the addition of rufinamide to the addition of any other AED of the investigator's choice to the existing regimen of 1 to 3 AEDs in paediatric patients, 1 to less than 4 years of age with inadequately controlled LGS.
Danish: Desuden blev Inovelon (rufinamid oral suspension) administreret i et åbent multicenterstudie, der sammenlignede tilføjelsen af rufinamid med andre antiepileptika tilsat efter investigatorens valg til det eksisterende program med 1 til 3 antiepileptika hos pædiatriske patienter i alderen 1 år til under 4 år med utilstrækkeligt kontrolleret LGS.
English: Follow the manufacturer's instructions for the feeding tube to administer the medicine.
Danish: Følg sondeproducentens anvisninger ved indgivelse af medicinen.
English: Use in patients with hepatic impairment has not been studied.
Danish: Anvendelse hos patienter med nedsat leverfunktion er ikke undersøgt.
English: 1.2 mg methyl parahydroxybenzoate (E218), 0.3 mg propyl parahydroxybenzoate (E216), 250 mg sorbitol (E420)
Danish: 1,2 mg methylparahydroxybenzoat (E218), 0,3 mg propylparahydroxybenzoat (E216) 250 mg sorbitol (E420).
English: As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients < 30 kg being co-administered valproate.
Danish: Da valproat signifikant nedsætter clearance af rufinamid, anbefales en lavere maksimaldosis af Inovelon hos patienter < 30 kg, som samtidigt behandles med valproat.
English: Treatment should be initiated at a daily dose of 200 mg.
Danish: Behandlingen bør indledes med en daglig dosis på 200 mg.
English: The most common adverse reactions observed at a higher incidence than placebo in patients with Lennox-Gastaut syndrome were somnolence and vomiting.
Danish: De mest almindelige bivirkninger, som blev observeret med en højere hyppighed end ved placebo hos patienter med Lennox-Gastaut-syndrom, var døsighed og opkastning.
English: The adverse event profile was similar to that in children 4 years of age and older, adolescents, and adults.
Danish: Profilen over uønskede hændelser svarede til profilen hos børn i alderen 4 år og ældre, unge og voksne.
English: It comes in a bottle of 460 ml with two identical syringes and a push in bottle adaptor (PIBA).
Danish: Det leveres i en flaske med 460 ml med to identiske injektionssprøjter og en push-in-bottle adapter (PIBA).
English: Treatment should be initiated at a daily dose of 400 mg.
Danish: Behandlingen bør indledes med en daglig dosis på 400 mg.
English: The most common adverse reactions resulting in discontinuation from the rufinamide treatment group were rash and vomiting.
Danish: De mest almindelige bivirkninger, som medførte seponering i rufinamid-behandlingsgruppen, var udslæt og opkastning.
English: The oral dosing syringes are graduated in 0.5 ml increments.
Danish: De orale doseringssprøjter er graduerede med 0,5 ml trin.
English: There are insufficient data on the withdrawal of concomitant antiepileptic medicinal products once seizure control has been achieved with the addition of rufinamide.
Danish: Der findes ikke tilstrækkelige data om seponering af samtidige antiepileptika, når der først er opnået kontrol over anfaldene ved tillægsbehandling med rufinamid.
English: Treatment should be initiated at a daily dose of 200 mg (5 ml dosing suspension given as two 2.5 ml doses, one in the morning and one in the evening).
Danish: Behandlingen bør indledes med en daglig dosis på 200 mg (5 ml doseringssuspension, der gives som to 2,5 ml doser, en om morgenen og en om aftenen).
English: Simeticone emulsion, 30% containing benzoic acid, cyclotetrasiloxane, dimethicone, glycol stearate and glyceryl distearate, methylcellulose, PEG-40 stearate (polyethylene glycol stearate), polysorbate 65, silica gel, sorbic acid, sulphuric acid and water.
Danish: Simeticon-emulsion, 30 % indeholdende benzoesyre, cyclotetrasiloxan, dimeticon, glycolstearat og glyceryldistearat, methylcellulose, PEG-40 stearat (polyethylenglycolstearat), polysorbat 65, silicagel, sorbinsyre, svovlsyre og vand.
English: The tablet should be taken twice daily with water in the morning and in the evening, in two equally divided doses.
Danish: Tabletten bør indtages to gange dagligt med vand, om morgenen og om aftenen, delt i to lige store doser.
English: Potassium sorbate (E202)
Danish: Kaliumsorbat (E202)
English: A specific interaction study in healthy subjects revealed no influence of rufinamide at a dose of 400 mg twice daily on the pharmacokinetics of olanzapine, a CYP1A2 substrate.
Danish: Et specifikt interaktionsstudie hos raske forsøgspersoner afslørede ingen indflydelse af rufinamid på farmakokinetikken af olanzapin, et CYP1A2-substrat, ved en dosis på 400 mg to gange dagligt.
English: No significant changes in rufinamide concentration are observed following co-administration with lamotrigine, topiramate or benzodiazepines.
Danish: Der er ikke observeret signifikante ændringer i rufinamidkoncentrationen efter indgivelse samtidig med lamotrigin, topiramat eller benzodiazepiner.
English: In rats, decreased cellularity of the bone marrow and thymic atrophy were observed only in the carcinogenicity study.
Danish: Hos rotter blev der kun observeret nedsat cellularitet i knoglemarven og thymus-atrofi i karcinogenitetsstudiet.
English: Croscarmellose sodium Hypromellose Magnesium stearate Sodium laurilsulfate Silica colloidal, anhydrous
Danish: Croscarmellosenatrium Hypromellose Magnesiumstearat Natriumlaurilsulfat Silica, kolloid vandfri
English: Insert adaptor into the neck of the bottle until a tight seal is made Push plunger of syringe completely down
Danish: Adapteren indsættes i flaskehalsen, indtil der opstår en tæt forsegling.
English: A recent population PK analysis of rufinamide on data pooled from 139 subjects (115 LGS patients and 24 healthy subjects), including 83 paediatric LGS patients (10 patients aged 1 to < 2 years, 14 patients aged 2 to < 4 years, 14 patients aged 4 to < 8 years, 21 patients aged 8 to < 12 years and 24 patients aged 12 to < 18 years) indicated that when rufinamide is dosed on a mg/kg/day basis in LGS subjects aged 1 to < 4 years, comparable exposure to that in LGS patients aged ≥ 4 years, in which efficacy has been demostrated, is achieved.
Danish: En nylig farmakokinetisk populationsanalyse med rufinamid af samlede data fra 139 forsøgspersoner (115 LGS-patienter og 24 raske forsøgspersoner), herunder 83 pædiatriske LGS-patienter (10 patienter i alderen 1 til < 2 år, 14 patienter i alderen 2 til < 4 år, 14 patienter i alderen 4 til < 8 år, 21 patienter i alderen 8 til < 12 år og 24 patienter i alderen 12 til < 18 år) antydede, at når rufinamid doseres som mg/kg/dag til LGSforsøgspersoner i alderen 1 til < 4 år, opnås der en eksponering, der kan sammenlignes med den hos LGS-patienter i alderen ≥ 4 år, hvor der er påvist effekt.
English: The syringes are graduated in 0.5 ml increments.
Danish: Injektionssprøjterne er graduerede med 0,5 ml trin.
English: Citric acid, anhydrous (E330)
Danish: Citronsyre, vandfri (E330)