natgillin/translations-raw huggingface dataset:
Rufinamid metaboliseres ved hydrolyse og metaboliseres ikke i nævneværdig grad af cytokrom P450 enzymer. 
Rufinamide is metabolised by hydrolysis, and is not metabolised to any notable degree by cytochrome P450 enzymes.
*Krydsreference til pkt. 
*Cross reference to section 4.4.
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. 
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.
Traumer, forgiftninger og behandlings-ko mplikationer 
Injury, poisoning and procedural complications
Miljørisikovurderingsstudier har vist, at rufinamid ikke nedbrydes ekstremt langsomt i miljøet (se pkt. 
Environmental risk assessment studies have shown that rufinamide is very persistent in the environment (see section 6.6).
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). 
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).
Mulighed for at andre lægemidler påvirker rufinamid 
Potential for other medicinal products to affect rufinamide
Et lille antal personer, som behandles med antiepileptika såsom Inovelon har overvejet selvbeskadigende adfærd/haft selvmordstanker. 
A small number of people being treated with antiepileptics such as Inovelon have had thoughts of harming or killing themselves.
Rufinamids sikkerhed og virkning hos nyfødte eller spædbørn og små børn i alderen under 1 år er ikke klarlagt. 
The safety and efficacy of rufinamide in new-born infants or infants and toddlers aged less than 1 year have not been established.
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. 
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.
Hver æske indeholder en flaske, to identiske kalibrerede orale doseringssprøjter og en press-in-bottle adapter (PIBA). 
Each carton contains one bottle, two identical calibrated oral dosing syringes and a press-in-bottle adapter (PIBA).
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 %. 
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%.
Desuden hæmmer rufinamid ikke aktiviteten af cytokrom P450 enzymer (se pkt. 
Furthermore, rufinamide does not inhibit the activity of cytochrome P450 enzymes (see section 5.2).
Det er blevet vist, at rufinamid inducerer CYP3A4 Rufinamid kan derfor reducere plasmakoncentrationerne af stoffer, der metaboliseres af dette enzym. 
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.
Suspensionen bør indtages to gange dagligt, om morgenen og om aftenen, delt i to lige store doser. 
The suspension should be taken twice daily in the morning and in the evening, in two equally divided doses.
Propylenglycol (E1520). 
Propylene glycol (E1520).
Inovelon indeholder lactose 
Inovelon contains lactose
Middelaktiviteten af CYP3A4, vurderet som triazolamclearance, blev forøget med 55 % efter 11 dages behandling med rufinamid 400 mg to gange dagligt. 
The mean CYP3A4 activity, assessed as clearance of triazolam, was increased by 55% after 11 days of treatment with rufinamide 400 mg twice daily.
Kontakt lægen eller på apoteket: 
Talk to your doctor or pharmacist if:
I kliniske studier gennemførtes seponering ved at reducere dosis med ca. 25 % hver anden dag. 
In clinical studies discontinuation was achieved by reducing the dose by approximately 25% every two days.
Aluminium/aluminium blister, pakninger med 10, 30, 50, 60 og 100 filmovertrukne tabletter. 
Aluminium/aluminium blisters, packs of 10, 30, 50, 60 and 100 film-coated tablets.
Den foreskrevne dosis af Inovelon oral suspension kan indgives via enteral sonde. 
The prescribed dose of Inovelon oral suspension can be administered via an enteral feeding tube.
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. 
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.
1 flaske med 460 ml indeholder 18.400 mg rufinamid. 
1 bottle of 460 ml contains 18400 mg rufinamide.
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. 
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.
Hvis du har glemt at tage Inovelon 
If you forget to take Inovelon
Rufinamidkoncentrationen er ikke underlagt klinisk relevante ændringer ved indgivelse samtidig med kendte enzyminducerende antiepileptika. 
Rufinamide concentrations are not subject to clinically relevant changes on co-administration with known enzyme inducing antiepileptic medicinal products.
Herudover har patienter oplevet: Angst, søvnløshed, næseblod, akne, udslæt, rygsmerter, uregelmæssig menstruation, blå mærker, beskadigelse af hovedet (som følge af kvæstelser under et anfald). 
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).
Inovelon er indiceret til supplerende behandling af anfald (epileptiske), som er associeret med Lennox-Gastaut-syndrom (LGS) hos patienter på 1 år og ældre. 
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.
Voksne, unge og børn, der vejer 30 kg eller derover 
Adults, adolescents and children weighing 30 kg or over
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. 
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).
For at sikre korrekt dosering skal den enterale sonde skylles mindst én gang med 1 ml vand efter indgivelse af den orale suspension. 
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.
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu 
Detailed information on this product is available on the European Medicines Agency website http://www.ema.europa.eu
Mulighed for at rufinamid påvirker andre lægemidler 
Potential for rufinamide to affect other medicinal products
Inovelon indeholder methylparahydroxybenzoat (E218) og propylparahydroxybenzoat (E216): Disse indholdsstoffer kan forårsage allergiske reaktioner (kan optræde efter behandlingen). 
Inovelon contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) These ingredients may cause allergic reactions (possibly delayed).
Doser på op til 3.600 mg/dag er blevet undersøgt hos et begrænset antal patienter. 
Doses of up to 3,600 mg/day have been studied in a limited number of patients.
Et studie hos patienter med alvorligt nedsat nyrefunktion indikerede, at der ikke kræves dosisjustering hos disse patienter (se pkt. 
A study in patients with severe renal impairment indicated that no dose adjustments are required for these patients (see section 5.2).
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. 
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.
Følg sondeproducentens anvisninger ved indgivelse af medicinen. 
Follow the manufacturer's instructions for the feeding tube to administer the medicine.
Anvendelse hos patienter med nedsat leverfunktion er ikke undersøgt. 
Use in patients with hepatic impairment has not been studied.
1,2 mg methylparahydroxybenzoat (E218), 0,3 mg propylparahydroxybenzoat (E216) 250 mg sorbitol (E420). 
1.2 mg methyl parahydroxybenzoate (E218), 0.3 mg propyl parahydroxybenzoate (E216), 250 mg sorbitol (E420)
Da valproat signifikant nedsætter clearance af rufinamid, anbefales en lavere maksimaldosis af Inovelon hos patienter < 30 kg, som samtidigt behandles med valproat. 
As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients < 30 kg being co-administered valproate.
Behandlingen bør indledes med en daglig dosis på 200 mg. 
Treatment should be initiated at a daily dose of 200 mg.
De mest almindelige bivirkninger, som blev observeret med en højere hyppighed end ved placebo hos patienter med Lennox-Gastaut-syndrom, var døsighed og opkastning. 
The most common adverse reactions observed at a higher incidence than placebo in patients with Lennox-Gastaut syndrome were somnolence and vomiting.
Profilen over uønskede hændelser svarede til profilen hos børn i alderen 4 år og ældre, unge og voksne. 
The adverse event profile was similar to that in children 4 years of age and older, adolescents, and adults.
Det leveres i en flaske med 460 ml med to identiske injektionssprøjter og en push-in-bottle adapter (PIBA). 
It comes in a bottle of 460 ml with two identical syringes and a push in bottle adaptor (PIBA).
Behandlingen bør indledes med en daglig dosis på 400 mg. 
Treatment should be initiated at a daily dose of 400 mg.
De mest almindelige bivirkninger, som medførte seponering i rufinamid-behandlingsgruppen, var udslæt og opkastning. 
The most common adverse reactions resulting in discontinuation from the rufinamide treatment group were rash and vomiting.
De orale doseringssprøjter er graduerede med 0,5 ml trin. 
The oral dosing syringes are graduated in 0.5 ml increments.
Der findes ikke tilstrækkelige data om seponering af samtidige antiepileptika, når der først er opnået kontrol over anfaldene ved tillægsbehandling med rufinamid. 
There are insufficient data on the withdrawal of concomitant antiepileptic medicinal products once seizure control has been achieved with the addition of rufinamide.
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). 
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).
Simeticon-emulsion, 30 % indeholdende benzoesyre, cyclotetrasiloxan, dimeticon, glycolstearat og glyceryldistearat, methylcellulose, PEG-40 stearat (polyethylenglycolstearat), polysorbat 65, silicagel, sorbinsyre, svovlsyre og vand. 
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.
Tabletten bør indtages to gange dagligt med vand, om morgenen og om aftenen, delt i to lige store doser. 
The tablet should be taken twice daily with water in the morning and in the evening, in two equally divided doses.
Kaliumsorbat (E202) 
Potassium sorbate (E202)
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. 
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.
Der er ikke observeret signifikante ændringer i rufinamidkoncentrationen efter indgivelse samtidig med lamotrigin, topiramat eller benzodiazepiner. 
No significant changes in rufinamide concentration are observed following co-administration with lamotrigine, topiramate or benzodiazepines.
Hos rotter blev der kun observeret nedsat cellularitet i knoglemarven og thymus-atrofi i karcinogenitetsstudiet. 
In rats, decreased cellularity of the bone marrow and thymic atrophy were observed only in the carcinogenicity study.
Croscarmellosenatrium Hypromellose Magnesiumstearat Natriumlaurilsulfat Silica, kolloid vandfri 
Croscarmellose sodium Hypromellose Magnesium stearate Sodium laurilsulfate Silica colloidal, anhydrous
Adapteren indsættes i flaskehalsen, indtil der opstår en tæt forsegling. 
Insert adaptor into the neck of the bottle until a tight seal is made Push plunger of syringe completely down
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. 
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.
Injektionssprøjterne er graduerede med 0,5 ml trin. 
The syringes are graduated in 0.5 ml increments.
Citronsyre, vandfri (E330) 
Citric acid, anhydrous (E330)
Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig. 
Tell the doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Parahydroxybenzoat 
Parahydroxybenzoates
Der er ikke udført studier hos patienter med nedsat leverfunktion og derfor bør Inovelon ikke administreres til patienter med alvorligt nedsat leverfunktion (se pkt. 
No studies have been performed in patients with hepatic impairment and therefore Inovelon should not be administered to patients with severe hepatic impairment (see section 4.2).
Der blev set en signifikant forbedring i de tre primære variabler: Den procentuelle ændring i den totale anfaldshyppighed pr. 28 dage under vedligeholdelsesfasen i forhold til baseline (-35,8 % med Inovelon vs. -1,6 % med placebo, p=0,0006), antallet af toniske-atoniske anfald (-42.9 % med Inovelon vs. 2,2 % med placebo, p=0,0002), og sværhedsgraden af anfald ud fra den samlede evaluering udført af forældre/værge ved afslutningen af den dobbeltblinde fase (stor forbedring eller meget stor forbedring hos 32,2 % i Inovelongruppen vs. 14,5 % i placebogruppen, p=0,0041). 
A significant improvement was observed for all three primary variables: the percentage change in total seizure frequency per 28 days during the maintenance phase relative to baseline (-35.8% on Inovelon vs. -1.6% on placebo, p=0.0006), the number of tonic-atonic seizures (-42.9% on Inovelon vs. 2.2% on placebo, p=0.0002), and the seizure severity rating from the Global Evaluation performed by the parent/guardian at the end of the double-blind phase (much or very much improved in 32.2% on Inovelon vs. 14.5% on the placebo arm, p=0.0041).
Kvinder i den fødedygtige alder, der anvender hormonale antikonceptionsmidler rådes til at anvende en supplerende sikker og effektiv svangerskabsforebyggende metode (se pkt. 
Women of child-bearing potential using hormonal contraceptives are advised to use an additional safe and effective contraceptive method (see sections 4.4 and 4.6).
Er du i tvivl, så spørg lægen eller på apoteket. 
- If you have any further questions, ask the doctor or pharmacist.
Anvendelse hos voksne, unge og børn på 4 år eller ældre på 30 kg eller derover 
Use in adults, adolescents and children 4 years of age or older of 30 kg or over
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/ 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
I det 13 uger lange studie blev en lav forekomst af knoglemarvsforandringer og lymfoide forandringer rapporteret hos hundyr ved den høje dosis. 
In the 13-week study, female bone marrow and lymphoid changes are reported at the high dose with a weak incidence.
Hvis du har suspension tilbage i flasken 90 dage efter, den blev åbnet første gang, må du ikke bruge den. 
If you have any suspension left in the bottle more than 90 days after it was first opened, do not use it. Do not use the suspension if you notice that the appearance or smell of your medicine has changed.
Den maksimale koncentration (Cmax) og plasma AUC for rufinamid stiger mindre end proportionalt med doserne hos både fastende og ikke fastende raske forsøgspersoner og hos patienter. 
Peak concentration (Cmax) and plasma AUC of rufinamide increase less than proportionally with doses in both fasted and fed healthy subjects and in patients, probably due to dose-limited absorption behaviour.
Hvis du har taget mere Inovelon, end der står her eller er foreskrevet af lægen, skal du straks fortælle det til lægen eller på apoteket, eller du skal kontakte den nærmeste skadestue. 
If you may have taken more Inovelon than you should, tell the doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking the medicine with you.
Mandlige og kvindelige patienter (mellem 4 og 30 år) blev inkluderet, hvis de havde flere typer anfald i anamnesen, som skulle omfatte atypiske anfald af absencer og anfald med fald (dvs. tonisk-atoniske eller astatiske anfald), hvis de samtidigt blev behandlet med 1 til 3 antiepileptika med fast dosering, hvis de havde mindst 90 anfald i måneden før den 28dages basislinjeperiode, et EEG inden for 6 måneder før de indgik i studiet, der viste et mønster med langsomme spike-and-wave-komplekser (2,5 Hz), en vægt på mindst 18 kg og en CT- eller MR-scanning, der bekræftede, at der ikke var nogen progressiv læsion til stede. 
Male and female patients (between 4 and 30 years of age) were eligible if they had a history of multiple seizure types, which had to include atypical absence seizures and drop attacks (i.e., tonic-atonic or astatic seizures); were being treated with 1 to 3 concomitant fixed dose antiepileptic medicinal products; a minimum of 90 seizures in the month before the 28-day baseline period; an EEG within 6 months of study entry demonstrating a pattern of slow spike-and-wave complexes (2.5 Hz); a weight of at least 18 kg; and a CT scan or MRI study confirming the absence of a progressive lesion.
Overfølsomhed over for det aktive stof, triazolderivater eller over for et eller flere af hjælpestofferne anført i pkt. 
Hypersensitivity to the active substance, triazole derivatives or to any of the excipients listed in section 6.1.
Problemer i forbindelse med maven, herunder: Mavesmerter, forstoppelse, fordøjelsesbesvær, løs afføring (diaré), tab eller ændring af appetit, vægttab. 
Problems associated with the stomach including: stomach pain, constipation, indigestion, loose stools (diarrhoea), loss or change in appetite, weight loss.
Rufinamid synes ikke at have nogen klinisk relevant effekt på steady state koncentrationerne af carbamazepin, lamotrigin, phenobarbital, topiramat, phenytoin eller valproat. 
Rufinamide appears not to have a clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate, phenytoin or valproate steady state concentrations.
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose og carmellosenatrium, citronsyre vandfri, simeticon-emulsion 30 % (indeholdende benzoesyre, cyclotetrasiloxan, dimeticon, glycolstearat og glyceryldistearat, methylcellulose, PEG-40 stearat [polyethylenglycolstearat], polysorbat 65, silicagel, sorbinsyre, svovlsyre og vand), poloaxamer 188, hydroxyethylcellulose, methylparahydroxybenzoat (E218), propylparahydroxybenzoat (E216), kaliumsorbat, propylenglycol (E1520), sorbitol, flydende (ikke-krystalliserende), appelsinsmag og vand. 
- The other ingredients are microcrystalline cellulose and carmellose sodium, anhydrous citric acid, 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), poloxamer 188, hydroxyethylcellulose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), potassium sorbate, propylene glycol (E1520), sorbitol, liquid (non-crystallising), orange flavour and water.
Problemer i forbindelse med nerver omfatter: Gangbesvær, unormale bevægelser, kramper/anfald, usædvanlige øjenbevægelser, sløret syn, rysten. 
Problems associated with nerves including: difficulty walking, abnormal movement, convulsions/seizures, unusual eye movements, blurred vision, trembling.
Hos rotter og aber blev der ikke fundet evidens for en associeret risiko ved toksicitetsstudier med gentagne doser. 
No evidence of an associated risk was identified in the rat and monkey repeat dose toxicity studies.
Seponering af rufinamid 
Withdrawal of rufinamide
Da valproat signifikant nedsætter clearance af rufinamid, anbefales en lavere maksimaldosis af Inovelon hos patienter, som samtidigt behandles med valproat. 
As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients being co-administered valproate.