FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell the doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Parahydroxybenzoates
Danish: Parahydroxybenzoat
English: 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).
Danish: Der er ikke udført studier hos patienter med nedsat leverfunktion og derfor bør Inovelon ikke administreres til patienter med alvorligt nedsat leverfunktion (se pkt.
English: 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).
Danish: 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).
English: 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).
Danish: Kvinder i den fødedygtige alder, der anvender hormonale antikonceptionsmidler rådes til at anvende en supplerende sikker og effektiv svangerskabsforebyggende metode (se pkt.
English: - If you have any further questions, ask the doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Use in adults, adolescents and children 4 years of age or older of 30 kg or over
Danish: Anvendelse hos voksne, unge og børn på 4 år eller ældre på 30 kg eller derover
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency 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: In the 13-week study, female bone marrow and lymphoid changes are reported at the high dose with a weak incidence.
Danish: I det 13 uger lange studie blev en lav forekomst af knoglemarvsforandringer og lymfoide forandringer rapporteret hos hundyr ved den høje dosis.
English: 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.
Danish: Hvis du har suspension tilbage i flasken 90 dage efter, den blev åbnet første gang, må du ikke bruge den.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Hypersensitivity to the active substance, triazole derivatives or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, triazolderivater eller over for et eller flere af hjælpestofferne anført i pkt.
English: Problems associated with the stomach including: stomach pain, constipation, indigestion, loose stools (diarrhoea), loss or change in appetite, weight loss.
Danish: Problemer i forbindelse med maven, herunder: Mavesmerter, forstoppelse, fordøjelsesbesvær, løs afføring (diaré), tab eller ændring af appetit, vægttab.
English: Rufinamide appears not to have a clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate, phenytoin or valproate steady state concentrations.
Danish: Rufinamid synes ikke at have nogen klinisk relevant effekt på steady state koncentrationerne af carbamazepin, lamotrigin, phenobarbital, topiramat, phenytoin eller valproat.
English: - 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.
Danish: - 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.
English: Problems associated with nerves including: difficulty walking, abnormal movement, convulsions/seizures, unusual eye movements, blurred vision, trembling.
Danish: Problemer i forbindelse med nerver omfatter: Gangbesvær, unormale bevægelser, kramper/anfald, usædvanlige øjenbevægelser, sløret syn, rysten.
English: No evidence of an associated risk was identified in the rat and monkey repeat dose toxicity studies.
Danish: Hos rotter og aber blev der ikke fundet evidens for en associeret risiko ved toksicitetsstudier med gentagne doser.
English: Withdrawal of rufinamide
Danish: Seponering af rufinamid
English: As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients being co-administered valproate.
Danish: Da valproat signifikant nedsætter clearance af rufinamid, anbefales en lavere maksimaldosis af Inovelon hos patienter, som samtidigt behandles med valproat.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flaskens etiket og kartonen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, hypromellose, magnesium stearate, sodium laurilsulfate and colloidal anhydrous silica.
Danish: - Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, majsstivelse, croscarmellosenatrium, hypromellose, magnesiumstearat, natriumlaurilsulfat og kolloid vandfri silica.
English: Each ml of oral suspension contains:
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver ml oral suspension indeholder:
English: Treatment should be initiated at a daily dose of 400 mg (10 ml dosing suspension given as two 5 ml doses).
Danish: Behandlingen bør indledes med en daglig dosis på 400 mg (10 ml doseringssuspension, der gives som to 5 ml doser).
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Status epilepticus
English: What you need to know before you take Inovelon
Danish: Det skal du vide, før du begynder at tage inovelon
English: 10 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 200 film-coated tablets
Danish: 10 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 60 filmovertrukne tabletter 100 filmovertrukne tabletter 200 filmovertrukne tabletter
English: 5 ml contains 200 mg rufinamide.
Danish: 5 ml indeholder 200 mg rufinamid.
English: Infections: ear infection, flu, nasal congestion, chest infection.
Danish: Infektioner: øreinfektion, influenza, stoppet næse, lungebetændelse.
English: - If you get any side effects, talk to the doctor or pharmacist.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: Patients receiving valproate:
Danish: Patienter, som får valproat:
English: In clinical trials rufinamide discontinuation was achieved by reducing the dose by approximately 25% every two days (see section 4.4).
Danish: I kliniske forsøg blev rufinamid seponeret ved at reducere dosis med ca. 25 % hver anden dag (se pkt.
English: The most frequently reported TEAEs in the rufinamide treatment group (occurring in ≥ 10% of subjects) were upper respiratory tract infection and vomiting (28.0% each), pneumonia and somnolence (20.0% each), sinusitis, otitis media, diarrhoea, cough and pyrexia (16.0% each), and bronchitis, constipation, nasal congestion, rash, irritability and decreased appetite (12.0% each).
Danish: De hyppigst rapporterede uønskede hændelser, der opstod under behandlingen (treatment emergent adverse events, TEAE'er) i gruppen behandlet med rufinamid (forekom hos ≥ 10 % af forsøgspersonerne) var infektion i de øvre luftveje og opkastning (28,0 % hver), pneumoni og somnolens (20,0 % hver), sinuitis, otitis media, diarré, hoste og pyreksi (16,0 % hver), og bronkitis, forstoppelse, stoppet næse, udslæt, irritabilitet og nedsat appetit (12,0 % hver).
English: The most commonly reported adverse reactions overall were headache, dizziness, fatigue, and somnolence.
Danish: De mest almindeligt rapporterede bivirkninger på samlet plan var hovedpine, svimmelhed, træthed og døsighed.
English: Inovelon 40 mg/ml oral suspension Rufinamide
Danish: Inovelon 40 mg/ml oral suspension Rufinamid
English: 10 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Danish: 10 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 60 filmovertrukne tabletter 100 filmovertrukne tabletter
English: Other associated manifestations included lymphadenopathy, liver function tests abnormalities, and haematuria.
Danish: Andre associerede manifestationer omfattede lymfadenopati, abnorme leverfunktionsprøver og hæmaturi.
English: If you get any side effects, talk to your doctor.
Danish: Hvis du får nogle af følgende bivirkninger, bør du fortælle det til lægen:
English: The recommended starting dose is 400 mg (10 ml) a day.
Danish: Den anbefalede startdosis er 400 mg (10 ml) dagligt.
English: For this patient population, the maximum recommended dose is 45 mg/kg/day (1.125 ml/kg/day).
Danish: Den maksimalt anbefalede dosis til denne patientpopulation er 45 mg/kg/dag (1,125 ml/kg/dag).
English: Doses of up to 4,000 mg/day (100 ml/day) in the 30 -50 kg range or 4,800 mg/day (120 ml/day) in the over 50 kg category have been studied in a limited number of patients.
Danish: Doser på op til 4.000 mg/dag (100 ml/dag) i 30-50 kg intervallet eller 4.800 mg/dag (120 ml/dag) i kategorien over 50 kg er blevet undersøgt hos et begrænset antal patienter.
English: Lactose monohydrate Cellulose, microcrystalline Maize starch
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Majsstivelse
English: INFORMATION IN BRAILLE Inovelon 40 mg/ml
Danish: INFORMATION I BRAILLESKRIFT Inovelon 40 mg/ml
English: The recommended starting dose is 200 mg (5 ml) a day.
Danish: Den anbefalede startdosis er 200 mg (5 ml) dagligt.
English: Patients with rare, hereditary problems of fructose intolerance should not take this medicine.
Danish: Dette lægemiddel bør ikke anvendes til patienter med hereditær fructoseintolerans.
English: Oligomenorrhoea
Danish: Oligomenoré
English: Other medicines and Inovelon
Danish: Brug af anden medicin sammen med Inovelon
English: Tel: + 31 (0) 900 575 3340
Danish: Tél/Tel: + 31 (0) 900 575 3340
English: Turn upright and remove the syringe
Danish: Vend flasken om, og fjern injektionssprøjten.
English: Tell the doctor if you are taking digoxin (a medicine used to treat heart conditions).
Danish: Fortæl lægen, hvis du tager hjertemedicinen digoxin.
English: Doses of up to 4,000 mg/day (in the 30 - -50 kg range) or 4,800 mg/day (in the over 50 kg) have been studied in a limited number of patients.
Danish: Doser på op til 4.000 mg/dag (i 30-50 kg intervallet) eller 4.800 mg/dag (for over 50 kg) er blevet undersøgt hos et begrænset antal patienter.
English: Women of childbearing potential must use contraceptive measures during treatment with rufinamide.
Danish: Kvinder i den fertile alder skal anvende svangerskabsforebyggende midler under behandlingen med rufinamid.
English: Tremor Diplopia Vision blurred
Danish: Tremor Diplopi Sløret syn
English: Somnolence* Status epilepticus* Convulsion
Danish: Døsighed* Status epilepticus* Hovedpine Krampe Svimmelhed* Koordinationsanomali*
English: Patients not receiving valproate:
Danish: Patienter, som ikke får valproat:
English: Thus, clinically significant interactions mediated through inhibition of cytochrome P450 system by rufinamide are unlikely to occur.
Danish: Det er således usandsynligt, at der vil forekomme klinisk signifikante interaktioner, som medieres af rufinamids hæmning af cytokrom P450 systemet.
English: Do not use this medicine after the expiry date which is stated on the blister and carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterpakningen og æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Treatment should be initiated at a dose of 10 mg/kg/day administered in two equally divided doses separated by approximately 12 hours.
Danish: Behandlingen bør indledes med en dosis på 10 mg/kg/dag administreret i to lige store doser med ca. 12 timers mellemrum.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 January 2007
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Doses of up to 3,600 mg/day (90 ml/day) have been studied in a limited number of patients.
Danish: Doser på op til 3.600 mg/dag (90 ml/dag) er blevet undersøgt hos et begrænset antal patienter.
English: Inovelon 100 mg film-coated tablets Inovelon 200 mg film-coated tablets Inovelon 400 mg film-coated tablets Rufinamide
Danish: Inovelon 100 mg filmovertrukne tabletter Inovelon 200 mg filmovertrukne tabletter Inovelon 400 mg filmovertrukne tabletter
English: They are available as packs of 10, 30, 50, 60,100 and 200 film-coated tablets.
Danish: De findes i pakninger med 10, 30, 50, 60, 100 og 200 filmovertrukne tabletter.
English: Each millilitre contains 40 mg of rufinamide.
Danish: Hver ml indeholder 40 mg rufinamid.
English: They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.
Danish: De findes i pakninger med 10, 30, 50, 60 og 100 filmovertrukne tabletter.
English: In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/or the illness is responsible has not been elucidated.
Danish: I hvilket omfang behandlingen og/eller sygdommen er ansvarlig, er imidlertid ikke blevet belyst.
English: The recommended starting dose is 10 mg for each kilogram of body weight, each day.
Danish: Den anbefalede startdosis er 10 mg for hvert kg legemsvægt, hver dag.
English: For this patient population, the maximum recommended dose is 30 mg/kg/day (0.75 ml/kg/day).
Danish: Den maksimalt anbefalede dosis til denne patientpopulation er 30 mg/kg/dag (0,75 ml/kg/dag).
English: Ferric oxide red (E172)
Danish: Rød jernoxid (E172).
English: Children 4 years of age or older weighing less than 30 kg
Danish: Børn på 4 år eller derover, som vejer under 30 kg
English: Treatment should be initiated at a dose of 10 mg/kg/day (0.25 ml/kg/day) administered in two equally divided doses separated by approximately 12 hours.
Danish: Behandlingen bør indledes med en dosis på 10 mg/kg/dag (0,25 ml/kg/dag) administreret i to lige store doser med ca. 12 timers mellemrum.
English: Maximum daily dose taking valproate is 600 mg each day.
Danish: Den maksimale daglige dosis, hvis du tager valproat, er 600 mg hver dag.
English: Propyl parahydroxybenzoate (E216)
Danish: Propylparahydroxybenzoat (E216)
English: Maximum daily dose taking valproate is 600 mg (15 ml) each day.
Danish: Den maksimale daglige dosis, hvis du tager valproat, er 600 mg (15 ml) hver dag.
English: In a radiotracer study in three healthy volunteers, the parent compound (rufinamide) was the main radioactive component in plasma, representing about 80% of the total radioactivity, and the metabolite CGP 47292 constituting only about 15%.
Danish: Rufinamid repræsenterende omkring 80 % af den totale radioaktivitet, og metabolitten CGP 47292 udgjorde kun omkring 15 %.
English: Maximum daily dose not taking valproate is 1,000 mg each day.
Danish: Den maksimale daglige dosis, hvis du ikke tager valproat, er 1.000 mg hver dag.
English: The recommended starting dose is 10 mg (0.25 ml) for each kilogram of body weight, each day.
Danish: Den anbefalede startdosis er 10 mg (0,25 ml) for hvert kg legemsvægt, hver dag.
English: Since the pharmacokinetics of rufinamide are not altered in older people (see section 5.2), dosage adjustment is not required in patients over 65 years of age.
Danish: 5.2), er dosisjusteringer ikke påkrævet hos patienter over 65 år.
English: Maximum daily dose not taking valproate is 1,000 mg (25 ml) each day.
Danish: Den maksimale daglige dosis, hvis du ikke tager valproat, er 1.000 mg (25 ml) hver dag.
English: NAME OF THE MEDICINAL PRODUCT Inovelon 40 mg/ml oral suspension
Danish: LÆGEMIDLETS NAVN Inovelon 40 mg/ml oral suspension
English: Coordination Abnormal* Nystagmus Psychomotor hyperactivity disorders
Danish: Døsighed* Status epilepticus* Hovedpine Kramper Svimmelhed* Koordinationsforstyrrelse* Nystagmus Psykomotorisk hyperaktivitet
English: Methyl parahydroxybenzoate (E218)
Danish: Methylparahydroxybenzoat (E218)
English: 2,200 mg/day or 55 ml/day
Danish: 2.200 mg/dag eller 55 ml/dag
English: Maximum daily dose not taking valproate is 45 mg (1.125 ml) for each kilogram of body weight, each day.
Danish: Den maksimale daglige dosis, hvis du ikke tager valproat, er 45 mg (1,125 ml) for hvert kg legemsvægt, hver dag.
English: System Organ Class
Danish: Systemorgan-kla sse
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of Inovelon oral suspension contains 40 mg rufinamide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml Inovelon oral suspension indeholder 40 mg rufinamid 1 flaske indeholder 18.400 mg rufinamid.
English: Insomnia
Danish: Angst Insomni
English: What Inovelon contains
Danish: Inovelon indeholder:
English: 1,800 mg/day or 45 ml/day
Danish: 1.800 mg/dag eller 45 ml/dag
English: Inovelon (rufinamide tablets) was administered in a double blind, placebo-controlled study, at doses of up to 45 mg/kg/day for 84 days, to 139 patients with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (including both atypical absence seizures and drop attacks).
Danish: Inovelon (rufinamid-tabletter) blev administreret i et dobbeltblindt, placebokontrolleret studie i doser på op til 45 mg/kg/dag i 84 dage til 139 patienter.
English: Use in patients with severe hepatic impairment is not recommended.
Danish: Anvendelse til patienter med nedsat leverfunktion frarådes.
English: Physicians should try to ensure that appropriate contraception is used, and should use clinical judgement when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate, based on the individual patients clinical situation (see sections 4.5 and 4.6).
Danish: Baseret på den individuelle patients kliniske situation bør lægerne forsøge at sikre, at der bliver anvendt passende antikonception, og de bør anvende klinisk skøn ved vurderingen af, hvorvidt oral antikonception eller dosen af den orale antikonceptions komponenter er tilstrækkelig (se pkt.
English: 3,200 mg/day or 80 ml/day
Danish: 3.200 mg/dag eller 80 ml/dag
English: For dosing, please use the syringe and adaptor provided.
Danish: Brug den medfølgende injektionssprøjte og adapter til dosering.
English: According to clinical response and tolerability, the dose may be increased by 400 mg/day increments, as frequently as every other day, up to a maximum recommended dose as indicated in the table below.
Danish: Dosis kan i henhold til klinisk respons og tolerance øges trinvist med 400 mg/dag, så hyppigt som hver anden dag, op til en maksimalt anbefalet dosis som angivet i nedenstående tabel.
English: Each 200 mg film-coated tablet contains 40 mg lactose (as monohydrate).
Danish: Hver 200 mg filmovertrukket tablet indeholder 40 mg lactose (som monohydrat).
English: Each 100 mg film-coated tablet contains 20 mg lactose (as monohydrate).
Danish: Hver 100 mg filmovertrukket tablet indeholder 20 mg lactose (som monohydrat).
English: 2,400 mg/day or 60 ml/day
Danish: 2.400 mg/dag eller 60 ml/dag
English: Women of childbearing potential must use contraceptive measures during treatment with Inovelon.
Danish: Kvinder, i den fødedygtige alder, skal anvende svangerskabsforebyggende midler under behandling med Inovelon.
English: Each 400 mg film-coated tablet contains 80 mg lactose (as monohydrate).
Danish: Hver 400 mg filmovertrukket tablet indeholder 80 mg lactose (som monohydrat).
English: 1,200 mg/day or 30 ml/day
Danish: 1.200 mg/dag eller 30 ml/dag
English: Nasogastric tube (NG): Polyvinyl chloride (PVC) tube of not greater than 40 cm in length and diameter of tube 5 Fr. 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: Nasogastrisk sonde (NG): Sonde af PVC (polyvinylchlorid) med en maksimal længde på 40 cm og en diameter på 1,67 mm (5 Fr).
English: NAME OF THE MEDICINAL PRODUCT Inovelon 40 mg/ml oral suspension Rufinamide
Danish: LÆGEMIDLETS NAVN Inovelon 40 mg/ml oral suspension Rufinamid
English: For this patient population, the maximum recommended dose is 30 mg/kg/day.
Danish: Den maksimalt anbefalede dosis til denne patientpopulation er 30 mg/kg/dag.