natgillin/translations-raw huggingface dataset:
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.
Brug ikke lægemidlet efter den udløbsdato, der står på flaskens etiket og kartonen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the bottle label and carton.
- Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, majsstivelse, croscarmellosenatrium, hypromellose, magnesiumstearat, natriumlaurilsulfat og kolloid vandfri silica.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, hypromellose, magnesium stearate, sodium laurilsulfate and colloidal anhydrous silica.
Hjælpestoffer, som behandleren skal være opmærksom på: Hver ml oral suspension indeholder:
Each ml of oral suspension contains:
Behandlingen bør indledes med en daglig dosis på 400 mg (10 ml doseringssuspension, der gives som to 5 ml doser).
Treatment should be initiated at a daily dose of 400 mg (10 ml dosing suspension given as two 5 ml doses).
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Status epilepticus
4.4 Special warnings and precautions for use
Det skal du vide, før du begynder at tage inovelon
What you need to know before you take Inovelon
10 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 60 filmovertrukne tabletter 100 filmovertrukne tabletter 200 filmovertrukne tabletter
10 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 200 film-coated tablets
5 ml indeholder 200 mg rufinamid.
5 ml contains 200 mg rufinamide.
Infektioner: øreinfektion, influenza, stoppet næse, lungebetændelse.
Infections: ear infection, flu, nasal congestion, chest infection.
Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
- If you get any side effects, talk to the doctor or pharmacist.
Patienter, som får valproat:
Patients receiving valproate:
I kliniske forsøg blev rufinamid seponeret ved at reducere dosis med ca. 25 % hver anden dag (se pkt.
In clinical trials rufinamide discontinuation was achieved by reducing the dose by approximately 25% every two days (see section 4.4).
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).
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).
De mest almindeligt rapporterede bivirkninger på samlet plan var hovedpine, svimmelhed, træthed og døsighed.
The most commonly reported adverse reactions overall were headache, dizziness, fatigue, and somnolence.
Inovelon 40 mg/ml oral suspension Rufinamid
Inovelon 40 mg/ml oral suspension Rufinamide
10 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 60 filmovertrukne tabletter 100 filmovertrukne tabletter
10 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Andre associerede manifestationer omfattede lymfadenopati, abnorme leverfunktionsprøver og hæmaturi.
Other associated manifestations included lymphadenopathy, liver function tests abnormalities, and haematuria.
Hvis du får nogle af følgende bivirkninger, bør du fortælle det til lægen:
If you get any side effects, talk to your doctor.
Den anbefalede startdosis er 400 mg (10 ml) dagligt.
The recommended starting dose is 400 mg (10 ml) a day.
Den maksimalt anbefalede dosis til denne patientpopulation er 45 mg/kg/dag (1,125 ml/kg/dag).
For this patient population, the maximum recommended dose is 45 mg/kg/day (1.125 ml/kg/day).
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.
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.
Lactosemonohydrat Mikrokrystallinsk cellulose Majsstivelse
Lactose monohydrate Cellulose, microcrystalline Maize starch
INFORMATION I BRAILLESKRIFT Inovelon 40 mg/ml
INFORMATION IN BRAILLE Inovelon 40 mg/ml
Den anbefalede startdosis er 200 mg (5 ml) dagligt.
The recommended starting dose is 200 mg (5 ml) a day.
Dette lægemiddel bør ikke anvendes til patienter med hereditær fructoseintolerans.
Patients with rare, hereditary problems of fructose intolerance should not take this medicine.
Oligomenoré
Oligomenorrhoea
Brug af anden medicin sammen med Inovelon
Other medicines and Inovelon
Vend flasken om, og fjern injektionssprøjten.
Turn upright and remove the syringe
Fortæl lægen, hvis du tager hjertemedicinen digoxin.
Tell the doctor if you are taking digoxin (a medicine used to treat heart conditions).
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.
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.
Kvinder i den fertile alder skal anvende svangerskabsforebyggende midler under behandlingen med rufinamid.
Women of childbearing potential must use contraceptive measures during treatment with rufinamide.
Tremor Diplopi Sløret syn
Tremor Diplopia Vision blurred
Døsighed* Status epilepticus* Hovedpine Krampe Svimmelhed* Koordinationsanomali*
Somnolence* Status epilepticus* Convulsion
Patienter, som ikke får valproat:
Patients not receiving valproate:
Det er således usandsynligt, at der vil forekomme klinisk signifikante interaktioner, som medieres af rufinamids hæmning af cytokrom P450 systemet.
Thus, clinically significant interactions mediated through inhibition of cytochrome P450 system by rufinamide are unlikely to occur.
Brug ikke lægemidlet efter den udløbsdato, der står på blisterpakningen og æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the blister and carton.
Behandlingen bør indledes med en dosis på 10 mg/kg/dag administreret i to lige store doser med ca. 12 timers mellemrum.
Treatment should be initiated at a dose of 10 mg/kg/day administered in two equally divided doses separated by approximately 12 hours.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 January 2007
Doser på op til 3.600 mg/dag (90 ml/dag) er blevet undersøgt hos et begrænset antal patienter.
Doses of up to 3,600 mg/day (90 ml/day) have been studied in a limited number of patients.
Inovelon 100 mg filmovertrukne tabletter Inovelon 200 mg filmovertrukne tabletter Inovelon 400 mg filmovertrukne tabletter
Inovelon 100 mg film-coated tablets Inovelon 200 mg film-coated tablets Inovelon 400 mg film-coated tablets Rufinamide
De findes i pakninger med 10, 30, 50, 60, 100 og 200 filmovertrukne tabletter.
They are available as packs of 10, 30, 50, 60,100 and 200 film-coated tablets.
Hver ml indeholder 40 mg rufinamid.
Each millilitre contains 40 mg of rufinamide.
De findes i pakninger med 10, 30, 50, 60 og 100 filmovertrukne tabletter.
They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.
I hvilket omfang behandlingen og/eller sygdommen er ansvarlig, er imidlertid ikke blevet belyst.
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.
Den anbefalede startdosis er 10 mg for hvert kg legemsvægt, hver dag.
The recommended starting dose is 10 mg for each kilogram of body weight, each day.
Den maksimalt anbefalede dosis til denne patientpopulation er 30 mg/kg/dag (0,75 ml/kg/dag).
For this patient population, the maximum recommended dose is 30 mg/kg/day (0.75 ml/kg/day).
Rød jernoxid (E172).
Ferric oxide red (E172)
Børn på 4 år eller derover, som vejer under 30 kg
Children 4 years of age or older weighing less than 30 kg
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.
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.
Den maksimale daglige dosis, hvis du tager valproat, er 600 mg hver dag.
Maximum daily dose taking valproate is 600 mg each day.
Propylparahydroxybenzoat (E216)
Propyl parahydroxybenzoate (E216)
Den maksimale daglige dosis, hvis du tager valproat, er 600 mg (15 ml) hver dag.
Maximum daily dose taking valproate is 600 mg (15 ml) each day.
Rufinamid repræsenterende omkring 80 % af den totale radioaktivitet, og metabolitten CGP 47292 udgjorde kun omkring 15 %.
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%.
Den maksimale daglige dosis, hvis du ikke tager valproat, er 1.000 mg hver dag.
Maximum daily dose not taking valproate is 1,000 mg each day.
Den anbefalede startdosis er 10 mg (0,25 ml) for hvert kg legemsvægt, hver dag.
The recommended starting dose is 10 mg (0.25 ml) for each kilogram of body weight, each day.
5.2), er dosisjusteringer ikke påkrævet hos patienter over 65 år.
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.
Den maksimale daglige dosis, hvis du ikke tager valproat, er 1.000 mg (25 ml) hver dag.
Maximum daily dose not taking valproate is 1,000 mg (25 ml) each day.
LÆGEMIDLETS NAVN Inovelon 40 mg/ml oral suspension
NAME OF THE MEDICINAL PRODUCT Inovelon 40 mg/ml oral suspension
Døsighed* Status epilepticus* Hovedpine Kramper Svimmelhed* Koordinationsforstyrrelse* Nystagmus Psykomotorisk hyperaktivitet
Coordination Abnormal* Nystagmus Psychomotor hyperactivity disorders
Methylparahydroxybenzoat (E218)
Methyl parahydroxybenzoate (E218)
2.200 mg/dag eller 55 ml/dag
2,200 mg/day or 55 ml/day
Den maksimale daglige dosis, hvis du ikke tager valproat, er 45 mg (1,125 ml) for hvert kg legemsvægt, hver dag.
Maximum daily dose not taking valproate is 45 mg (1.125 ml) for each kilogram of body weight, each day.
Systemorgan-kla sse
System Organ Class
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml Inovelon oral suspension indeholder 40 mg rufinamid 1 flaske indeholder 18.400 mg rufinamid.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of Inovelon oral suspension contains 40 mg rufinamide.
Angst Insomni
Insomnia
Inovelon indeholder:
What Inovelon contains
1.800 mg/dag eller 45 ml/dag
1,800 mg/day or 45 ml/day
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.
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).
Anvendelse til patienter med nedsat leverfunktion frarådes.
Use in patients with severe hepatic impairment is not recommended.
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.
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).
3.200 mg/dag eller 80 ml/dag
3,200 mg/day or 80 ml/day
Brug den medfølgende injektionssprøjte og adapter til dosering.
For dosing, please use the syringe and adaptor provided.
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.
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.
Hver 200 mg filmovertrukket tablet indeholder 40 mg lactose (som monohydrat).
Each 200 mg film-coated tablet contains 40 mg lactose (as monohydrate).
Hver 100 mg filmovertrukket tablet indeholder 20 mg lactose (som monohydrat).
Each 100 mg film-coated tablet contains 20 mg lactose (as monohydrate).
2.400 mg/dag eller 60 ml/dag
2,400 mg/day or 60 ml/day
Kvinder, i den fødedygtige alder, skal anvende svangerskabsforebyggende midler under behandling med Inovelon.
Women of childbearing potential must use contraceptive measures during treatment with Inovelon.
Hver 400 mg filmovertrukket tablet indeholder 80 mg lactose (som monohydrat).
Each 400 mg film-coated tablet contains 80 mg lactose (as monohydrate).
1.200 mg/dag eller 30 ml/dag
1,200 mg/day or 30 ml/day
Nasogastrisk sonde (NG): Sonde af PVC (polyvinylchlorid) med en maksimal længde på 40 cm og en diameter på 1,67 mm (5 Fr).
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.
LÆGEMIDLETS NAVN Inovelon 40 mg/ml oral suspension Rufinamid
NAME OF THE MEDICINAL PRODUCT Inovelon 40 mg/ml oral suspension Rufinamide
Den maksimalt anbefalede dosis til denne patientpopulation er 30 mg/kg/dag.
For this patient population, the maximum recommended dose is 30 mg/kg/day.
Den maksimalt anbefalede dosis til denne patientpopulation er 45 mg/kg/dag.
For this patient population, the maximum recommended dose is 45 mg/kg/day.
Methylparahydroxybenzoat (E218) Propylparahydroxybenzoat (E216) Sorbitol (E420)
Also contains methyl parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) sorbitol (E420)
Den maksimale daglige dosis, hvis du tager valproat, er højst 2.200 mg (55 ml), afhængigt af din legemsvægt.
Maximum daily dose taking valproate is no more than 2,200 mg (55 ml), depending on body weight.
INFORMATION I BRAILLESKRIFT Inovelon 200 mg tabletter
INFORMATION IN BRAILLE Inovelon 200 mg tablets
Dosis kan efter klinisk respons og tolerance øges trinvist med 200 mg/dag så hyppigt som hver tredje dag, op til en maksimalt anbefalet dosis på 1.000 mg/dag (25 ml/dag).
According to clinical response and tolerability, the dose may be increased by 200 mg/day increments, as frequently as every third day, up to a maximum recommended dose of 1,000 mg/day (25 ml/day).
Den maksimale daglige dosis, hvis du tager valproat, er -30 mg (0,75 ml) for hvert kg legemsvægt, hver dag.
Maximum daily dose taking valproate is 30 mg (0.75 ml) for each kilogram of body weight, each day.
2.400 mg/dag
2,400 mg/day
1.800 mg/dag
1,800 mg/day
Den maksimale daglige dosis, hvis du ikke tager valproat er højst 3.200 mg (80 ml), afhængigt af din legemsvægt.
Maximum daily dose not taking valproate is no more than 3,200 mg (80 ml), depending on body weight.
Den maksimale daglige dosis, hvis du ikke tager valproat, er 45 mg for hvert kg legemsvægt, hver dag.
Maximum daily dose not taking valproate is 45 mg for each kilogram of body weight, each day.
Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
If you have been told by the doctor that you have an intolerance to some sugars, contact the doctor before taking this medicinal product.
Nedsat nyrefunktion
Constipation Dyspepsia
Den kan blive forhøjet med 200 mg hver tredje dag.
The dose will be calculated for you by the doctor and may be increased by 200 mg every third day.
1.600 mg/dag eller 40 ml/dag
1,600 mg/day or 40 ml/day
INFORMATION I BRAILLESKRIFT Inovelon 400 mg tabletter
INFORMATION IN BRAILLE Inovelon 400 mg tablets
Den maksimale daglige dosis, hvis du tager valproat, er 30 mg for hvert kg legemsvægt, hver dag.
Maximum daily dose taking valproate is 30 mg for each kilogram of body weight, each day.
INFORMATION I BRAILLESKRIFT Inovelon 100 mg tabletter
INFORMATION IN BRAILLE Inovelon 100 mg tablets
Den kan blive forhøjet med 400 mg (10 ml) hver anden dag.
The dose will be calculated for you by the doctor and may be increased by 400 mg (10 ml) every other day.
Patienter > 30 kg, som ikke får valproat:
Patients < 30 kg not receiving valproate:
Anvendelse hos børn på 4 år eller derover, som vejer under 30 kg
Use in children 4 years of age or older and less than 30 kg
Dosis kan efter klinisk respons og tolerance øges med op til 10 mg/kg/dag (0,25 ml/kg/dag) hver tredje dag til en måldosis på 45 mg/kg/dag (1,125 ml/kg/dag), som administreres i to lige store doser med ca. 12 timers mellemrum.
According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day (0.25 ml/kg/day) every third day to a target dose of 45 mg/kg/day (1.125 ml/kg/day) administered in two equally divided doses separated by approximately 12 hours.