natgillin/translations-raw huggingface dataset:
For dosing, please use the syringe and adaptor provided.
Za doziranje uporabite priloženu štrcaljku i nastavak.
You may experience the following side effects with this medicine.
Uz ovaj lijek možete osjetiti sljedeće nuspojave.
Rufinamide appears not to have a clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate, phenytoin or valproate steady state concentrations.
Čini se da rufinamid nema klinički važan učinak na koncentracije karbamazepina, lamotrigina, fenobarbitala, topiramata, fenitoina ili valproata u stanju dinamičke ravnoteže.
Status epilepticus
Epileptički status
If you forget to take Inovelon
Ako ste zaboravili uzeti Inovelon
A study in patients with severe renal impairment indicated that no dose adjustments are required for these patients (see section 5.2).
Ispitivanje u bolesnika s teškim oštećenjem funkcije bubrega pokazalo je da nije potrebna prilagodba doze u ovih bolesnika (vidjeti dio 5.2).
The film-coating consists of hypromellose, macrogols (8000), titanium dioxide (E171), talc and ferric oxide red (E172).
Film-ovojnica sastoji se od hipromeloze, makrogola (8000), titanijevog dioksida (E171), talka i crvenog željezovog oksida (E172).
Thus, clinically significant interactions mediated through inhibition of cytochrome P450 system by rufinamide are unlikely to occur.
Stoga nije vjerojatno da će nastupiti klinički značajne interakcije posredovane inhibicijom sustava citokroma P450 izazvanom rufinamidom.
Problems associated with the stomach including: stomach pain, constipation, indigestion, loose stools (diarrhoea), loss or change in appetite, weight loss.
Tegobe povezane sa želucem, uključujući: bol u želucu, zatvor, probavne smetnje, mekane stolice (proljev), gubitak ili promjena apetita, gubitak na tjelesnoj težini.
Inovelon oral suspension and Inovelon film-coated tablets may be interchanged at equal doses.
Inovelon oralna suspenzija i Inovelon filmom obložene tablete međusobno su zamjenjive u jednakim dozama.
There are insufficient data on the withdrawal of concomitant antiepileptic medicinal products once seizure control has been achieved with the addition of rufinamide.
Nema dovoljno podataka o prestanku primjene istodobno davanih antiepileptičkih lijekova nakon što se jednom postigla kontrola napadaja uz dodavanje 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).
Značajno poboljšanje bilo je opaženo u sve tri primarne varijable: u postotku promjene ukupne učestalosti napadaja u 28 dana tijekom faze održavanja u odnosu na početnu vrijednost (-35,8% za Inovelon nasuprot -1,6% za placebo, p=0,0006), broju toničko-atoničkih napadaja (-42,9% za Inovelon nasuprot 2,2% za placebo, p=0,0002) i ocjeni roditelja/skrbnika na temelju ljestvice za opću procjenu težine napadaja na kraju dvostruko slijepe faze (jako ili vrlo jako poboljšanje u 32,2% ispitanika u skupini koja je primala Inovelon nasuprot 14,5% u skupini koja je primala placebo, p=0,0041).
Renal excretion was the predominant route of elimination for active substance related material, accounting for 84.7% of the dose.
Izlučivanje putem bubrega bilo je glavni put eliminacije tvari povezanih s djelatnom tvari, čineći 84,7% doze.
AED treatment during pregnancy should be carefully discussed with the treating physician.
O liječenju antiepileptičkim lijekovima tijekom trudnoće potrebno je detaljno razgovarati s nadležnim liječnikom.
*Cross reference to section 4.4.
*Vidjeti također dio 4.4.
In rats, decreased cellularity of the bone marrow and thymic atrophy were observed only in the carcinogenicity study.
U štakora su smanjena celularnost koštane srži i atrofija timusa bile opažene samo u ispitivanju kancerogenosti.
Adverse reactions were usually mild to moderate in severity.
Nuspojave su obično bile blage do umjereno teške.
Patients receiving valproate:
Bolesnici koji primaju valproat:
It is not known if rufinamide is excreted in human breast milk.
Nije poznato izlučuje li se rufinamid u majčino mlijeko u ljudi.
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.
Bolesnici muškog i ženskog spola (u dobi od 4 do 30 godina) bili su uključeni ako su u povijesti bolesti imali više vrsta napadaja, koje su morale uključivati atipične apsans napadaje i astatičke napadaje (tj. toničko-atoničke ili astatičke napadaje); istodobno su bili liječeni s 1 do 3 antiepiletička lijeka u fiksnoj dozi; imali su najmanje 90 napadaja u mjesecu prije 28-dnevnog početnog razdoblja; EEG unutar 6 mjeseci od ulaska u ispitivanje koji je pokazao obrazac sporih šiljak-val kompleksa (2,5 Hz); tjelesnu težinu od najmanje 18 kg; i CT nalaz ili MR snimka kojima se potvrdila odsutnost progresivne lezije.
Tremor Diplopia Vision blurred
Tremor diplopija zamagljen vid
See section 6.6 for further details.
Za dodatne informacije vidjeti dio 6.6.
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.
Inovelon je indiciran kao dodatna terapija u liječenju napadaja povezanih s Lennox-Gastautovim sindromom u bolesnika u dobi od 1 ili više godina.
Each carton contains 1 bottle, 2 syringes and 1 press-in-bottle adapter (PIBA).
Jedna kutija sadrži 1 bocu, 2 štrcaljke i 1 nastavak za bocu (PIBA).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral suspension contains 40 mg rufinamide.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml oralne suspenzije sadrži 40 mg rufinamida.
Do not use this medicine after the expiry date which is stated on the blister and carton.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji.
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.
Dodatno, Inovelon (oralna suspenzija rufinamida) je bio primijenjen u multicentričnom otvorenom ispitivanju u kojem se dodavanje rufinamida uspoređivalo s dodavanjem nekog drugog antiepileptičkog lijeka po izboru ispitivača postojećem režimu koji se sastojao od 1 do 3 antiepileptička lijeka u pedijatrijskih bolesnika u dobi od 1 do manje od 4 godine s neodgovarajuće kontroliranim Lennox-Gastautovim sindromom.
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.
Nuspojava koja nije bila opažena u kliničkim ispitivanjima, ali je bila primijećena kod životinja pri razinama izloženosti koje su bile slične kliničkoj razini izloženosti i možda važna za primjenu u ljudi, bila je mijelofibroza koštane srži u ispitivanju kancerogenosti u miša.
For patients on Inovelon treatment who have administration of valproate initiated, significant increases in rufinamide plasma concentrations may occur.
U bolesnika liječenih Inovelonom, u kojih se započne s primjenom valproata, može doći do značajnog povećanja koncentracije rufinamida u plazmi.
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.
Inovelon sadrži laktozu; stoga ovaj lijek ne smiju uzimati bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze.
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).
Nisu provedena ispitivanja u bolesnika s oštećenjem funkcije jetre pa se stoga Inovelon ne smije primjenjivati u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dio 4.2).
Potential for other medicinal products to affect rufinamide
Mogućnost utjecaja drugih lijekova na rufinamid
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.
Preporučuje se pažljivo pratiti bolesnike liječene tvarima koje metabolizira sustav enzima CYP3A4, u razdoblju od dva tjedna nakon početka ili prestanka liječenja rufinamidom ili nakon bilo koje izrazitije promjene doze.
This indicates minimal risk of drug-drug interactions by displacement from binding sites during concomitant administration of other substances.
To pokazuje da, tijekom istodobne primjene, postoji minimalni rizik od interakcija s drugim lijekovima putem istiskivanja s mjesta vezanja.
If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest whole 100 mg tablet.
Ukoliko se preporučena izračunata doza Inovelona ne može postići, potrebno je dati dozu zaokruženu na najbliži višekratnik doze od 100 mg.
Taken in two equal doses, half in the morning and the other half in the evening.
Uzima se podijeljeno u dvije jednake doze, pola doze ujutro i pola navečer.
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).
Najčešće zabilježene nuspojave opažene tijekom liječenja u skupini liječenoj rufinamidom (koje su nastale u ≥ 10% ispitanika) bile su infekcije gornjih dišnih putova i povraćanje (svaka u 28,0%), pneumonija i somnolencija (svaka u 20,0%), sinusitis, upala srednjeg uha, proljev, kašalj i pireksija (svaka u 16,0%) te bronhitis, zatvor, kongestija nosa, osip, razdražljivost i smanjeni apetit (svaka u 12,0%).
Insert the syringe into the opening of the adaptor as far as possible.
Umetnite štrcaljku u otvor na nastavku što dublje.
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.
U multicentričnom otvorenom ispitivanju u kojem se uspoređivalo dodavanje rufinamida s dodavanjem nekog drugog antiepileptičkog lijeka po izboru ispitivača postojećem režimu koji se sastojao od 1 do 3 antiepileptička lijeka u pedijatrijskih bolesnika u dobi od 1 do manje od 4 godine s neodgovarajuće kontroliranim Lennox-Gastautovim sindromom, 25 bolesnika, od kojih je 10 bilo u dobi od 1 do 2 godine, bilo je izloženo rufinamidu kao dodatnoj terapiji tijekom 24 tjedna u dozi do 45 mg/kg na dan podijeljenoj u dvije doze.
It comes in a bottle of 460 ml with two identical syringes and a push in bottle adaptor (PIBA).
Dolazi u boci od 460 ml s dvije jednake štrcaljke i nastavkom koji se utisne u otvor boce.
Each carton contains one bottle, two identical calibrated oral dosing syringes and a press-in-bottle adapter (PIBA).
Jedna kartonska kutija sadrži jednu bocu, dvije jednake kalibrirane štrcaljke za oralno doziranje i nastavak koji se utisne u otvor boce (PIBA).
No evidence of an associated risk was identified in the rat and monkey repeat dose toxicity studies.
U ispitivanjima toksičnosti ponovljene doze u štakora i majmuna nije pronađen nikakav dokaz s time povezanog rizika.
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).
Liječenje treba započeti dnevnom dozom od 200 mg (5 ml doze suspenzije koja se daje podijeljena u dvije doze od 2,5 ml, jedna ujutro i druga navečer).
Adults, adolescents and children weighing 30 kg or over
Odrasli, adolescenti i djeca tjelesne težine od 30 kg ili više
The antiepileptic drug (AED) hypersensitivity syndrome occurred in close temporal association to the initiation of rufinamide therapy and in the paediatric population.
Nastanak sindroma preosjetljivosti na antiepileptičke lijekove usko je vremenski povezan s početkom terapije rufinamidom te s pedijatrijskom populacijom.
If you have any further questions on the use of this product, ask the doctor or pharmacist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
Inovelon 40 mg/ml oral suspension Rufinamide
Inovelon 40 mg/ml oralna suspenzija rufinamid
Regarding the immunotoxic potential, small thymus and thymic involution were observed in dogs in a 13-week study with significant response at the high dose in male.
U pogledu imunotoksičnog potencijala, u 13-tjednom ispitivanju u pasa opaženi su mali timus i involucija timusa, sa značajnim odgovorom pri visokim dozama u mužjaka.
The suspension should be taken twice daily in the morning and in the evening, in two equally divided doses.
Suspenziju treba uzimati dvaput na dan, ujutro i navečer, tako da je ukupna dnevna doza razdijeljena u dvije jednake doze.
The dosing syringe should be inserted into the PIBA and the dose withdrawn from the inverted bottle.
Štrcaljku za doziranje treba uvesti u nastavak i iz boce okrenute naopako izvući dozu lijeka.
The most common adverse reactions resulting in discontinuation from the rufinamide treatment group were rash and vomiting.
Najčešće nuspojave, koje su rezultirale prekidom u skupini liječenoj rufinamidom bile su osip i povraćanje.
Rufinamide is for oral use.
Rufinamid je namijenjen za peroralnu primjenu.
1 bottle contains 18400 mg rufinamide.
1 boca sadrži 18 400 mg rufinamida.
5 ml contains 200 mg rufinamide.
5 ml sadrži 200 mg rufinamida.
1 bottle of 460 ml contains 18400 mg rufinamide.
Jedna boca od 460 ml sadrži 18 400 mg rufinamida.
They are available as packs of 10, 30, 50, 60,100 and 200 film-coated tablets.
Dostupne su u pakiranjima od 10, 30, 50, 60,100 i 200 filmom obloženih tableta.
Treatment should be initiated at a daily dose of 400 mg.
Liječenje treba započeti dnevnom dozom od 400 mg.
Treatment should be initiated at a daily dose of 400 mg (10 ml dosing suspension given as two 5 ml doses).
Liječenje treba započeti dnevnom dozom od 400 mg (10 ml suspenzije koja se daje podijeljena u dvije doze od 5 ml).
Patients not receiving valproate:
Bolesnici koji ne primaju valproat:
Treatment should be initiated at a daily dose of 200 mg.
Liječenje treba započeti dnevnom dozom od 200 mg.
Use in patients with severe hepatic impairment is not recommended.
Ne preporučuje se primjena u bolesnika s teškim oštećenjem jetre.
- 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.
- Ostali sastojci su mikrokristalična celuloza i karmelozanatrij, bezvodna citratna kiselina, 30% -tna simetikon emulzija (koja sadrži benzoatnu kiselinu, ciklotetrasiloksan, dimetikon, glikolstearat i glicerildistearat, metilcelulozu, PEG-40 stearat [polietilenglikolstearat], polisorbat 65, gel silicijevog dioksida, sorbatnu kiselinu, sulfatnu kiselinu i vodu), poloksamer 188, hidroksietilceluloza, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), kalijev sorbat (E202), propilenglikol (E1520), sorbitol tekući (nekristalizirajući), aroma naranče i voda.
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.
Nuspojave za koje je zabilježena incidencija veća od one uz placebo, u dvostruko slijepim ispitivanjima u bolesnika s Lennox-Gastautovim sindromom i ukupnoj populaciji izloženoj rufinamidu, navedene su u sljedećoj tablici, prema MedDRA standardnim izrazima, klasifikaciji organskih sustava i učestalosti.
Also contains methyl parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) sorbitol (E420)
Također sadrži metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) sorbitol (E420)
Withdrawal of rufinamide
Prestanak primjene rufinamida
For rufinamide, no clinical data on exposed pregnancies are available.
Nema dostupnih kliničkih podataka o izloženosti rufinamidu u trudnoći.
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 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta 200 filmom obloženih tableta
Nervous system Somnolence* Status epilepticus*
Psihijatrijski poremećaji somnolencija* epileptički status* glavobolja
10 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
10 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta
Turn upright and remove the syringe
Okrenite bocu uspravno i izvucite štrcaljku.
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.
Nedavna populacijska farmakokinetička analiza rufinamida, napravljana na podacima prikupljenim od 139 ispitanika (115 bolesnika s Lennox-Gastautovim sindromom i 24 zdrava ispitanika), uključujući 83 pedijatrijska bolesnika s Lennox-Gastautovim sindromom (10 bolesnika u dobi od 1 do < 2 godine, 14 bolesnika u dobi od 2 to < 4 godine, 14 bolesnika u dobi od 4 to < 8 godina, 21 bolesnik u dobi od 8 do < 12 godina i 24 bolesnika u dobi od 12 do < 18 godina), pokazala je da se uz doziranje rufinamida po principu mg/kg/dan, u bolesnika s Lennox-Gastautovim sindromom u dobi od 1 do < 4 godine postiže izloženost usporediva s onom u bolesnika s Lennox-Gastautovim sindromom u dobi ≥ 4 godine, a u kojih je djelotvornost već ustanovljena.
Inovelon is used with other medicines to treat seizures associated with Lennox-Gastaut syndrome in adults, adolescents and children from 1 year of age.
Inovelon se primjenjuje s drugim lijekovima za liječenje odraslih, adolescenata i djece od navršene 1 godine koji imaju napadaje povezane s Lennox-Gastautovim sindromom.
For this patient population, the maximum recommended dose is 45 mg/kg/day (1.125 ml/kg/day).
Za ovu populaciju bolesnika, maksimalna preporučena doza je 45 mg/kg na dan (1,125 ml/kg na dan).
Discontinuation of rufinamide
Prekid primjene rufinamida
The tablet should be taken twice daily with water in the morning and in the evening, in two equally divided doses.
Tabletu treba uzimati dvaput na dan s vodom, ujutro i navečer, tako da je ukupna dnevna doza razdijeljena u dvije jednake doze.
Doses of up to 3,600 mg/day have been studied in a limited number of patients.
Doze do 3600 mg na dan ispitane su na ograničenom broju bolesnika.
INFORMATION IN BRAILLE Inovelon 40 mg/ml
16. PODACI NA BRAILLEOVOM PISMU Inovelon 40 mg/ml
If you are a woman of childbearing age, you must use contraceptive measures while taking Inovelon.
Ako ste žena koja može zatrudnjeti, za vrijeme uzimanja Inovelona morate koristiti kontracepcijske metode.
The recommended starting dose is 400 mg (10 ml) a day.
Preporučena početna doza je 400 mg (10 ml) na dan.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of Inovelon oral suspension contains 40 mg rufinamide.
NAVOĐENJE DJELATNE(IH) TVARI 1 ml Inovelon oralne suspenzije sadrži 40 mg rufinamida.
Each millilitre contains 40 mg of rufinamide.
Jedan mililitar sadrži 40 mg rufinamida.
Rufinamide concentrations are not subject to clinically relevant changes on co-administration with known enzyme inducing antiepileptic medicinal products.
Ne dolazi do klinički važnih promjena koncentracije rufinamida kod istodobne primjene antiepileptičkih lijekova za koje se zna da induciraju enzime.
They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.
Dostupne su u pakiranjima od 10, 30, 50, 60 i 100 filmom obloženih tableta.
Conventional safety pharmacology studies revealed no special hazards at clinically relevant doses.
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije pri klinički važnim dozama.
For this patient population, the maximum recommended dose is 30 mg/kg/day (0.75 ml/kg/day).
Za ovu populaciju bolesnika, maksimalna preporučena doza je 30 mg/kg na dan (0,75 ml/kg na dan).
The recommended starting dose is 200 mg (5 ml) a day.
Preporučena početna doza je 200 mg (5 ml) na dan.
Use in adults, adolescents and children 4 years of age or older of 30 kg or over
Primjena u odraslih, adolescenata i djece u dobi od 4 ili više godina tjelesne težine od 30 kg ili više
Eating disorder Decreased appetite Anxiety
Poremećaji metabolizma i prehrane poremećaj prehrane smanjen apetit anksioznost Nesanica
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.
Doze do 4000 mg na dan (100ml na dan) u rasponu tjelesne težine od 30 - 50 kg ili 4800 mg na dan (120 ml na dan) u kategoriji tjelesne težine veće od 50 kg ispitane su na ograničenom broju bolesnika.
A total of 12 patients received any-other AED at the investigator's discretion in the control arm.
Ukupno je 12 bolesnika u kontrolnoj skupini primalo neki drugi antiepileptički lijek po izboru ispitivača.
Women of childbearing potential
Žene koje mogu zatrudnjeti
Women of childbearing potential must use contraceptive measures during treatment with Inovelon.
Žene reproduktivne dobi moraju primjenjivati kontracepcijske mjere tijekom liječenja Inovelonom.
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.
Doze do 4000 mg na dan (u rasponu tjelesne težine od 30- - 50 kg) ili 4800 mg na dan (kod tjelesne težine veće od 50 kg) ispitane su na ograničenom broju bolesnika.
How to use Inovelon
Kako uzimati Inovelon