natgillin/translations-raw huggingface dataset:
A dose adjustment of the concomitantly administered medicinal product may need to be considered.
Mogoče bo treba pretehtati možnost prilagoditve odmerka zdravila, ki ga bolnik sočasno jemlje.
Inovelon oral suspension must be taken twice every day, once in the morning and once in the evening.
Peroralno suspenzijo Inovelon morate jemati dvakrat na dan, zjutraj in zvečer.
See section 3 - ‘How to use Inovelon' for advice on taking Inovelon with food and drink.
Za nasvete o jemanju zdravila Inovelon skupaj s hrano in pijačo glejte poglavje 3 »Kako jemati zdravilo Inovelon«.
- 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.
- Druge sestavine zdravila so mikrokristalna celuloza in natrijev karmelozat, brezvodna citronska kislina, 30-odstotna simetikonska emulzija (vsebuje benzojsko kislino, ciklotetrasiloksan, dimetikon, glikol stearat in gliceril distearat, metilcelulozo, PEG-40 stearat [polietilen glikol stearat], polisorbat 65, silicijev dioksid, sorbinsko kislino, žveplovo kislino in vodo), poloksamer 188, hidroksietilcelulozo, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), kalijev sorbat, propilenglikol (E1520), sorbitol, tekoči (nekristalizirajoči), aromo pomaranče in vodo.
For dosing, please use the syringe and adaptor provided.
Za odmerjanje uporabite priloženo brizgo in nastavek.
- The active substance is rufinamide.
- Zdravilna učinkovina je rufinamid.
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).
Neželeni učinki zaradi zdravljenja, o katerih so najpogosteje poročali v skupini, zdravljeni z rufinamidom (pojavljali so se pri ≥10 % bolnikov), so bili okužbe zgornjih dihal in bruhanje (vsak po 28,0 %), pljučnica in somnolenca (vsak po 20,0 %), sinuzitis, vnetje srednjega ušesa, driska, kašelj in zvišana telesna temperatura (vsak po 16,0 %) in bronhitis, zaprtje, kongestija nosne sluznice, izpuščaj, razdražljivost in zmanjšan apetit (vsak po 12,0 %).
10 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 200 film-coated tablets
10 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet 200 filmsko obloženih tablet
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.
Simetikonska emulzija, 30-odstotna, ki vsebuje benzojsko kislino, ciklotetrasiloksan, dimetikon, glikol stearat in gliceril distearat, metilcelulozo, PEG-40 stearat (polietilen glikol stearat), polisorbat 65, silicijev dioksid, sorbinsko kislino, žveplovo kislino in vodo.
10 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
10 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet
Eating disorder Decreased appetite Anxiety
Presnovne in prehranske motnje motnja hranjenja zmanjšan apetit anksioznost nespečnost
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih kontuzije
No evidence of an associated risk was identified in the rat and monkey repeat dose toxicity studies.
V raziskavah toksičnosti ponavljajočih se odmerkov pri podganah in opicah niso ugotovili znakov nevarnosti, povezanih z zdravilom.
No data are available on the effects on fertility following treatment with rufinamide.
Podatki o vplivu zdravljenja z rufinamidom na plodnost niso na voljo.
Women of childbearing potential must use contraceptive measures during treatment with Inovelon.
Ženske v rodni dobi morajo med zdravljenjem z zdravilom Inovelon uporabljati kontracepcijo.
5 ml contains 200 mg rufinamide.
5 ml vsebuje 200 mg rufinamida.
For patients on Inovelon treatment who have administration of valproate initiated, significant increases in rufinamide plasma concentrations may occur.
Pri bolnikih, ki se zdravijo z zdravilom Inovelon in jim uvedejo še valproat, se lahko pomembno zviša plazemska koncentracija rufinamida.
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).
Ugotovili so signifikantno izboljšanje vseh treh primarnih spremenljivk: spremembe celotne pogostnosti epileptičnih napadov v odstotkih na 28 dni v vzdrževalni fazi glede na izhodišče (-35,8 % pri zdravilu Inovelon v primerjavi z -1,6 % pri placebu, p=0,0006), števila tonično-atoničnih napadov (-42,9 % pri zdravilu Inovelon v primerjavi z 2,2 % pri placebu, p=0,0002) in ocene teže epileptičnih napadov iz globalne ocene, ki jo je opravil eden od staršev ali skrbnik na koncu dvojno slepe faze (precejšnje ali zelo veliko izboljšanje pri 32,2 % pri zdravilu Inovelon v primerjavi s 14,5 % v kraku s placebom, p=0,0041).
Therefore, consideration should be given to a dose reduction of Inovelon in patients who are initiated on valproate therapy (see section 4.2).
Zato je treba pri bolnikih, ko jim uvedemo zdravljenje z valproatom, pretehtati možnost zmanjšanja odmerka zdravila Inovelon (glejte poglavje 4.2).
They are available as packs of 10, 30, 50, 60,100 and 200 film-coated tablets.
Na voljo so v škatlah, v katerih je po 10, 30, 50, 60,100 ali 200 filmsko obloženih tablet.
Inovelon 40 mg/ml oral suspension Rufinamide
Inovelon 40 mg/ml peroralna suspenzija rufinamid
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).
Pri bolnikih z okvarami jeter študij niso opravili, zato pri bolnikih s težkimi okvarami jeter zdravila Inovelon ne smemo uporabljati (glejte poglavje 4.2).
It comes in a bottle of 460 ml with two identical syringes and a push in bottle adaptor (PIBA).
Na voljo je v plastenkah po 460 ml z dvema identičnima brizgama in vtisljivim nastavkom (PIBA).
The oral dosing syringes are graduated in 0.5 ml increments.
Oznake na brizgi za peroralno odmerjanje naraščajo po 0,5 mililitra.
If you have any further questions on the use of this product, ask the doctor or pharmacist.
Če imate dodatna vprašanja o jemanju zdravila, se posvetujte z zdravnikom ali s farmacevtom.
Use in adults, adolescents and children 4 years of age or older of 30 kg or over
Uporaba pri odraslih, mladostnikih in otrocih, starih 4 leta ali starejših, ki tehtajo 30 kg ali več
For this patient population, the maximum recommended dose is 45 mg/kg/day (1.125 ml/kg/day).
Pri tej populaciji bolnikov je največji priporočeni odmerek 45 mg/kg/dan (1,125 ml/kg/dan).
Inovelon oral suspension and Inovelon film-coated tablets have been demonstrated to be bioequivalent.
Dokazano je bilo, da sta zdravilo Inovelon peroralna suspenzija in zdravilo Inovelon filmsko obložene tablete bioekvivalentna.
As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients being co-administered valproate.
Ker valproat bistveno zmanjša očistek rufinamida, je pri bolnikih, ki sočasno uporabljajo valproat, priporočljiv manjši maksimalni odmerek zdravila Inovelon.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, hypromellose, magnesium stearate, sodium laurilsulfate and colloidal anhydrous silica.
- Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza, koruzni škrob, premreženi natrijev karmezolat, hipromeloza, magnezijev stearat, natrijev lavrilsulfat in brezvodni koloidni silicijev dioksid.
INFORMATION IN BRAILLE Inovelon 40 mg/ml
PODATKI V BRAILLOVI PISAVI Inovelon 40 mg/ml
Inovelon contains lactose
Zdravilo Inovelon vsebuje laktozo
Other associated manifestations included lymphadenopathy, liver function tests abnormalities, and haematuria.
Med drugimi pojavi, povezanimi s tem sindromom, so bili limfadenopatija, nenormalnosti jetrnih funkcijskih testov in hematurija.
Rufinamide concentrations are not subject to clinically relevant changes on co-administration with known enzyme inducing antiepileptic medicinal products.
Spremembe koncentracije rufinamida pri sočasnem dajanju z antiepileptiki, za katere je znano, da inducirajo encim, niso klinično pomembne.
Doses of up to 3,600 mg/day have been studied in a limited number of patients.
Pri omejenem številu bolnikov so proučevali odmerke do 3.600 mg/dan.
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).
Zdravniki morajo poskusiti zagotoviti, da bolnice uporabljajo ustrezno kontracepcijo, in naj pri ocenjevanju, ali zadostujejo peroralni kontraceptivi oziroma odmerki posameznih sestavin v peroralnih kontraceptivih, uporabljajo klinično presojo na podlagi kliničnega položaja posameznih bolnic (glejte poglavji 4.5 in 4.6).
Rufinamide was not teratogenic in mice, rats or rabbits.
Pri miših, podganah in kuncih rufinamid ni bil teratogen.
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 4.4 and 4.5).
Zdravniki morajo poskusiti zagotoviti, da bolnice uporabljajo ustrezno kontracepcijo, in naj pri ocenjevanju, ali zadostujejo peroralni kontraceptivi oziroma odmerki posameznih sestavin v peroralnih kontraceptivih, uporabljajo klinično presojo na podlagi kliničnega položaja posameznih bolnic (glejte poglavje 4.4 in 4.5).
Each millilitre contains 40 mg of rufinamide.
En mililiter vsebuje 40 mg rufinamida.
Each carton contains one bottle, two identical calibrated oral dosing syringes and a press-in-bottle adapter (PIBA).
Ena škatla vsebuje eno plastenko, dve identični umerjeni brizgi za peroralno odmerjanje in vtisljivi nastavek PIBA.
For this patient population, the maximum recommended dose is 30 mg/kg/day (0.75 ml/kg/day).
Pri tej populaciji bolnikov je največji priporočeni odmerek 30 mg/kg/dan (0,75 ml/kg/dan).
Problems associated with the stomach including: stomach pain, constipation, indigestion, loose stools (diarrhoea), loss or change in appetite, weight loss.
težave, povezane z želodcem, med drugim: bolečine v želodcu, zaprtje, prebavne motnje, redko blato (driska), izguba ali sprememba teka, izguba telesne mase.
How to store Inovelon
Kako jemati zdravilo Inovelon
Adults, adolescents and children weighing 30 kg or over
Odrasli, mladostniki in otroci s telesno maso 30 kg ali več
They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.
Na voljo so v škatlah, v katerih je po 10, 30, 50, 60 ali 100 filmsko obloženih tablet.
Caution and careful dose titration is recommended when treating patients with mild to moderate hepatic impairment.
Pri zdravljenju bolnikov z blago do zmerno okvaro jeter priporočamo previdnost in skrbno titriranje odmerka.
Oligomenorrhoea
Okvara ledvic
Rufinamide is metabolised by hydrolysis, and is not metabolised to any notable degree by cytochrome P450 enzymes.
Rufinamid se presnavlja s hidrolizo, encimi s citokromom P450 pa ga ne presnavljajo v znatnejši meri.
Treatment should be initiated at a daily dose of 400 mg (10 ml dosing suspension given as two 5 ml doses).
Zdravljenje je treba začeti z dnevnim odmerkom 400 mg (odmerek 10 ml suspenzije v obliki dveh 5 ml odmerkov).
Rufinamide is almost exclusively eliminated by metabolism.
Rufinamid se odstranjuje iz telesa skoraj samo s presnovo.
Tell the doctor if you are taking the blood thinner - warfarin.
Obvestite svojega zdravnika, če jemljete zdravilo za redčenje krvi varfarin.
Maximum daily dose taking valproate is 600 mg each day.
Največji dnevni odmerek, če jemljete valproat, je 600 mg na dan.
In a multicentre, open-label study comparing the addition of rufinamide to 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, 25 patients, of which 10 subjects were aged 1 to 2 years, were exposed to rufinamide as adjunctive therapy for 24 weeks at a dose of up to 45 mg/kg/day, in 2 divided doses.
Pediatrična populacija (starost od 1 do manj kot 4 leta) V multicentrični, odprti študiji, v kateri so primerjali dodatek rufinamida s katerim koli drugim antiepileptičnim zdravilom po presoji raziskovalca obstoječi shemi 1 do 3 antiepileptičnih zdravil pri pediatričnih bolnikih, starih od 1 do manj kot 4 leta, z nezadostno kontroliranim LGS, je bilo 25 bolnikov, od katerih je bilo 10 bolnikov starih 1 do 2 leti, 24 tednov izpostavljenih rufinamidu kot adjuvantnemu zdravilu v odmerku do 45 mg/kg/dan v 2 razdeljenih odmerkih.
Maximum daily dose not taking valproate is 45 mg (1.125 ml) for each kilogram of body weight, each day.
Največji dnevni odmerek, če ne jemljete valproata, je 45 mg (1,125 ml) na kilogram telesne mase vsak dan.
Treatment should be initiated at a dose of 10 mg/kg/day administered in two equally divided doses separated by approximately 12 hours.
Zdravljenje je treba začeti z odmerkom 10 mg/kg/dan, ki ga dajemo v dveh enakomerno razdeljenih odmerkih s presledkom približno 12 ur.
In the 13-week study, female bone marrow and lymphoid changes are reported at the high dose with a weak incidence.
V 13-tedenski študiji so pri visokih odmerkih z nizko incidenco poročali o spremembah kostnega mozga pri ženskih osebkih in o limfoidnih spremembah.
Maximum daily dose taking valproate is 30 mg (0.75 ml) for each kilogram of body weight, each day.
Največji dnevni odmerek, če jemljete valproat, je 30 mg (0,75 ml) na kilogram telesne mase vsak dan.
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.
V primerjavi z zdravimi prostovoljci se pri osebah s kronično in težko ledvično odpovedjo farmakokinetika enkratnega 400-miligramskega odmerka rufinamida ni spremenila.
NAME OF THE MEDICINAL PRODUCT Inovelon 40 mg/ml oral suspension
IME ZDRAVILA Inovelon 40 mg/ml peroralna suspenzija
STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of Inovelon oral suspension contains 40 mg rufinamide.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml peroralne suspenzije zdravila Inovelon vsebuje 40 mg rufinamida.
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.
Zdravljenje je treba začeti z odmerkom 10 mg/kg/dan (0,25 ml/kg/dan), ki ga dajemo v dveh enakomerno razdeljenih odmerkih s presledkom približno 12 ur.
Hypromellose Macrogols (8000) Titanium dioxide (E171) Talc
Filmska obloga hipromeloza makrogoli (8000) titanov dioksid (E171) smukec rdeči železov oksid (E172)
Maximum daily dose taking valproate is 600 mg (15 ml) each day.
Največji dnevni odmerek, če jemljete valproat, je 600 mg (15 ml) na dan.
EU/1/06/378/011-016
EU/1/06/378/001-005 EU/1/06/378/006-010 EU/1/06/378/011-016
Turn upright and remove the syringe
Plastenko obrnite v navpičen položaj in izvlecite brizgo.
Warnings and precautions Talk to your doctor or pharmacist if: - you have Congenital Short QT Syndrome or a family history of such a syndrome (electrical disturbance of the heart), as taking rufinamide could make it worse.
Posvetujte se z zdravnikom ali farmacevtom, če: - imate sindrom prirojenega kratkega intervala QT ali družinsko anamnezo tega sindroma
For this patient population, the maximum recommended dose is 30 mg/kg/day.
Pri tej populaciji bolnikov je največji priporočeni odmerek 30 mg/kg/dan.
Alternatively, use the score line to break the tablet into two equal halves.
Druga možnost je razdelitev tablete na zarezi na enaki polovici.
- If you get any side effects, talk to the doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Maximum daily dose not taking valproate is 1,000 mg each day.
Največji dnevni odmerek, če ne jemljete valproata, je 1.000 mg na dan.
1 bottle contains 18400 mg rufinamide.
1 plastenka vsebuje 18.400 mg rufinamida.
Doses of up to 3,600 mg/day (90 ml/day) have been studied in a limited number of patients.
Pri omejenem številu bolnikov so proučevali odmerke do 3.600 mg/dan (90 ml/dan).
The dose will be calculated for you by the doctor and may be increased by 400 mg every other day.
Odmerek bo izračunal zdravnik in ga lahko vsak drugi dan poveča v korakih po 400 mg.
Maximum daily dose not taking valproate is 1,000 mg (25 ml) each day.
Največji dnevni odmerek, če ne jemljete valproata, je 1.000 mg (25 ml) na dan.
What Inovelon contains
Kaj vsebuje zdravilo Inovelon
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.
Pri omejenem številu bolnikov so proučevali odmerke do 4.000 mg/dan (v razponu telesne mase 30 - 50 kg) oziroma do 4.800 mg/dan (preko 50 kg).
The dose will be calculated for you by the doctor and may be increased by 10 mg (0.25 ml) for each kilogram of body weight, every third day.
Odmerek bo izračunal zdravnik in ga lahko vsak tretji dan poveča v korakih po 10 mg (0,25 ml) na kilogram telesne mase.
As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients < 30 kg being co-administered valproate.
Ker valproat signifikantno zmanjša očistek rufinamida, priporočamo bolnikom s telesno maso, manjšo od 30 kg, ki sočasno jemljejo valproat, manjši maksimalni odmerek zdravila Inovelon.
Inovelon 100 mg film-coated tablets Inovelon 200 mg film-coated tablets Inovelon 400 mg film-coated tablets Rufinamide
Inovelon 100 mg filmsko obložene tablete Inovelon 200 mg filmsko obložene tablete Inovelon 400 mg filmsko obložene tablete rufinamid
The cap should be replaced after each use.
Po vsaki uporabi ponovno namestite zaporko.
2,200 mg/day or 55 ml/day
2.200 mg/dan ali 55 ml/dan
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Pri bolnikih, zdravljenih z antiepileptiki, so za številne indikacije poročali o samomorilnih mislih in vedenju.
The dose will be calculated for you by the doctor and may be increased by 200 mg every third day.
Odmerek bo izračunal zdravnik in ga lahko vsak tretji dan poveča v korakih po 200 mg.
For this patient population, the maximum recommended dose is 45 mg/kg/day.
Pri tej populaciji bolnikov je največji priporočeni odmerek 45 mg/kg/dan.
Very common (more than 1 in 10 patients) side effects of Inovelon are:
Obvestite svojega zdravnika, če opazite katerega od spodaj navedenih neželenih učinkov: Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov) zdravila Inovelon so:
Musculoskeletal and connective tissue and bone disorders
Bolezni mišično-skeletne ga sistema, vezivnega tkiva in kosti bolečina v hrbtu
1,800 mg/day or 45 ml/day
1.800 mg/dan ali 45 ml/dan
Also contains methyl parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) sorbitol (E420)
Vsebuje tudi metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), sorbitol (E420).
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.
Glede na klinični odziv in prenašanje zdravila lahko odmerek postopoma povečujemo po 400 mg/dan celo vsak drugi dan do največjega priporočenega odmerka, navedenega v spodnji preglednici.
Maximum daily dose taking valproate is no more than 2,200 mg (55 ml), depending on body weight.
Največji dnevni odmerek, če jemljete valproat, je 2.200 mg (55 ml), odvisno od vaše telesne mase.
Children 4 years of age or older weighing less than 30 kg
Otroci, stari 4 leta ali več, s telesno maso manjšo od 30 kg
2,400 mg/day or 60 ml/day
2.400 mg/dan ali 60 ml/dan
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).
Glede na klinični odziv in prenašanje zdravila lahko odmerek postopoma povečujemo po 200 mg/dan celo vsak tretji dan do največjega priporočenega odmerka 1.000 mg/dan (25 ml/dan).
Conventional safety pharmacology studies revealed no special hazards at clinically relevant doses.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti ne kažejo posebnega tveganja za človeka.
Maximum daily dose not taking valproate is no more than 3,200 mg (80 ml), depending on body weight.
Največji dnevni odmerek, če ne jemljete valproata, je 3.200 mg (80 ml), odvisno od vaše telesne mase.
Maximum daily dose taking valproate is 30 mg for each kilogram of body weight, each day.
Največji dnevni odmerek, če jemljete valproat, je 30 mg na kilogram telesne mase vsak dan.
3,200 mg/day or 80 ml/day
3.200 mg/dan ali 80 ml/dan
1,800 mg/day
1.800 mg/dan
The dose will be calculated for you by the doctor and may be increased by 10 mg for each kilogram of body weight, every third day.
Odmerek bo izračunal zdravnik in ga lahko vsak tretji dan poveča v korakih po 10 mg na kilogram telesne mase.
Each 200 mg film-coated tablet contains 40 mg lactose (as monohydrate).
Ena 200-miligramska filmsko obložena tableta vsebuje 40 mg laktoze (v obliki monohidrata).
Each 100 mg film-coated tablet contains 20 mg lactose (as monohydrate).
Ena 100-miligramska filmsko obložena tableta vsebuje 20 mg laktoze (v obliki monohidrata).
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.
Priporočamo, da v začetku in po koncu zdravljenja z rufinamidom ter po vsaki večji spremembi odmerka dva tedna skrbno spremljate bolnike, zdravljene z učinkovinami, ki jih presnavlja encimski sistem CYP3A4.
Maximum daily dose not taking valproate is 45 mg for each kilogram of body weight, each day.
Največji dnevni odmerek, če ne jemljete valproata, je 45 mg na kilogram telesne mase vsak dan.
Each 400 mg film-coated tablet contains 80 mg lactose (as monohydrate).
Ena 400-miligramska filmsko obložena tableta vsebuje 80 mg laktoze (v obliki monohidrata).
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.
Pri omejenem številu bolnikov so proučevali odmerke do 4.000 mg/dan (100 ml/dan) pri bolnikih z razponom telesne mase 30 - 50 kg oziroma do 4.800 mg/dan (120 ml/dan) pri bolnikih s telesno maso več kot 50 kg.
1,200 mg/day or 30 ml/day
1.200 mg/dan ali 30 ml/dan