natgillin/translations-raw huggingface dataset:
Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinyl-estradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
Levetiracetam primijenjen u dozi od 1000 mg na dan nije utjecao na farmakokinetiku oralnih kontraceptiva (etinilestradiola i levonorgestrela); endokrini pokazatelji (luteinizirajući hormon i progesteron) ostali su nepromijenjeni.
United Kingdom
Ujedinjeno Kraljevtsvo
If you take more Levetiracetam Accord than you should The possible side effects of an overdose of Levetiracetam are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Ako uzmete više Levetiracetam Accord nego što ste trebali Moguće su nuspojave predoziranja levetiracetamom pospanost, uznemirenost, agresija, smanjena pozornost, smetnje disanja i koma.
Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg /kg bodyweight.
Uslijed potpune i linearne apsorpcije levetiracetama, moguće je na temelju oralne doze izražene u mg/kg tjelesne težine predvidjeti razinu lijeka u plazmi.
In this study, the patients received levetiracetam as a fixed dose of 60 mg /kg/day (with twice a day dosing).
Bolesnici su u toj studiji dobivali konstantnu dozu od 60 mg/kg/dan (doziranje dva puta na dan).
If stopping treatment, Levetiracetam Accord should be discontinued gradually to avoid an increase of seizures.
Ako prekidate liječenje Levetiracetam Accordom, prekid mora biti postupan kako bi se izbjeglo pojačanje napadaja.
Children and adolescents - Levetiracetam Accord is not indicated in children and adolescents below 16 years on its own
• U djece i adolescenata mlađih od 16 godina Levetiracetam Accord se ne primjenjuje samostalno
In this study, levetiracetam dose was 3000 mg /day for adults and adolescents or 60 mg /kg/day for children, given in 2 divided doses.
Doza levetiracetama u toj studiji bila je 3000 mg na dan za odrasle i adolescente a za djecu 60 mg/kg/dan, podjeljeno na dvije doze.
Unit dose pack (perforated unit dose blister) containing 30x1, 60x1 and 100x1 tablets.
Pakiranja djeljiva na jedinične doze (perforirani blister djeljiv na jedinične doze) sadrže 30x1, 60x1 i 100x1 tableta.
Box of 10, 20, 30, 50, 60, 100, 200 tablets
Kutija od 10, 20, 30, 50, 60, 100, 200 tableta
In this study, patients were prescribed 20 mg /kg, 25 mg /kg, 40 mg /kg or 50 mg /kg daily dose of oral solution based on their age titration schedule.
U toj je studiji bolesnicima propisana oralna otopina u dnevnoj dozi od 20 mg/kg, 25 mg/kg, 40 mg/kg ili 50 mg/kg prema shemi titriranja ovisnoj o dobi.
Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, non-inferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Djelotvornost levetiracetama za samostalno liječenje dokazana je kod paralelnih grupa u dvostrukoslijepoj usporedbi neinferiornosti s karbamazepinom s kontroliranim otpuštanjem (CR, controlled release) na 576 bolesnika u dobi od 16 godina ili starijih s novo- ili nedavno dijagnosticiranom epilepsijom.
Following single oral dose administration (20 mg /kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
Nakon primjene jedne oralne doze (20 mg/kg) u djece s epilepsijom (6 do 12 godina), poluvrijeme života levetiracetama bio je 6,0 sati.
Following repeated oral dose administration (20 to 60 mg /kg/day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed.
Nakon ponovljene primjene oralne doze (20 do 60 mg/kg/na dan) u djece s epilepsijom (4 do 12 godina), levetiracetam se brzo apsorbira.
The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50% reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Primarna mjera učinkovitosti bila je stopa bolesnika s odgovorom (postotak bolesnika u kojih je dnevna prosječna učestalost napadaja smanjena za ≥ 50% u odnosu na početno stanje) određena središnjim pregledavanjem 48-satnog video EEG-a od strane ocjenjivača koji nije znao tko je dobivao placebo, a tko lijek.
Each film-coated tablet contains 250 mg, 500 mg, 750 mg or 1000 mg of levetiracetam.
Jedna filmom obložena tableta sadrži 250 mg, 500 mg, 750 mg ili 1000 mg levetiracetama.
An oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50kg and when tablets don't allow accurate dosage.
Oralna otopina je prikladniji farmaceutski oblik za primjenu u dojenčadi i djece mlađe od 6 godina, djece i adolescenata (6-17 godina) tjelesne težine manje od 50 kg te kada se tabletama ne može postići točno doziranje.
Four embryo-foetal development studies were performed in rabbits covering doses of 200, 600, 800, 1200 and 1800 mg /kg/day.
Četiri studije embrio-fetalnog razvoja provedene su u kunića s dozama od 200, 600, 800, 1200 i 1800 mg/kg/dan.
Levetiracetam efficacy was established in a 24-week double-blind, placebo-controlled study which included adults, adolescents and a limited number of children suffering from idiopathic generalized epilepsy with primary generalized tonic-clonic (PGTC) seizures in different syndromes (juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening).
Djelotvornost levetiracetama dokazana je u dvostruko-slijepoj i placebom kontroliranoj studiji u trajanju od 24 tjedna, koja je uključivala odrasle, adolescente i ograničeni broj djece s idiopatskom generaliziranom epilepsijom s primarno generaliziranim toničko-kloničkim (PGTK) napadajima kod različitih sindroma (juvenilna mioklonična epilepsija, epilepsija s apsansima dječje i juvenilne dobi ili epilepsija s grand mal napadajima kod buđenja).
• decreased blood sodium concentrations
• snižena koncentracija natrija u krvi;
In children and adolescents aged 4 to 16 years, vomiting (very common, 11.2%), agitation (common, 3.4%), mood swings (common, 2.1%), affect lability (common, 1.7%), aggression (common, 8.2%), abnormal behaviour (common, 5.6%), and lethargy (common, 3.9%) were reported more frequently than in other age ranges or in the overall safety profile.
U djece i adolescenata u dobi 4 do 16 godina povraćanje (vrlo često, 11,2%), agitacija (često, 3,4%), promjene raspoloženja (često, 2,1%), labilnost afekta (često, 1,7%), agresija (često, 8,2%), poremećaj ponašanja
A dose of 20 mg /kg/day titrating to 40 mg /kg/day for infants one month to less than six months and a dose of 25 mg /kg/day titrating to 50 mg /kg/day for infants and children 6 months to less than 4 years old, was use in this study.
Doza od 20 mg/kg/dan titrirana je do 40 mg/kg/dan u dojenčadi u dobi od jednog do manje od 6 mjeseci, a doza od 25 mg/kg/dan titrirana je do 50 mg/kg/dan u dojenčadi i djece u dobi od 6 mjeseci do manje od 4 godine.
Levetiracetam Accord 750 mg film-coated tablets contains sunset yellow (E110) which may cause allergic reactions.
Levetiracetam Accord 750 mg filmom obložene tablete sadrže bojilo sunset yellow (E110) koje može uzrokovati alergijske reakcije.
For children 6 years and above, Levetiracetam oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
U djece od 6 godina i starije, Levetiracetam oralnu otopinu treba primijenjivati za doze ispod 250 mg, doze koje nisu višekratnici od 250 mg, odnosno kada preporučeno doziranje ne može biti postignuto uzimanjem većeg broja tableta te u bolesnika koji ne mogu gutati tablete.
Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination,anger, confusional state, panic attack, affect lability/mood swings, agitation
Pokušaj samoubojstva, suicidalne misli, psihotični poremećaj, poremećaj ponašanja, halucinacije, srditost, konfuzno stanje, napadaj panike, labilnost afekta/promjene raspoloženja, agitacija
[140-age (years)] x weight (kg) CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
CLcr (ml/min) = ----------------------------------------------- (x 0,85 za žene) 72 x kreatinin u serumu (mg/dl)
Following single dose administration (20 mg /kg) of a 100 mg /ml oral solution to epileptic children (1 month to 4 years), levetiracetam was rapidly absorbed and peak plasma concentrations were observed approximately 1 hour after dosing.
Nakon primjene jedne doze (20 mg/kg) 100 mg/ml oralne otopine u djece s epilepsijom (1 mjesec do 4 godine), levetiracetam se brzo apsorbira te je vršna koncentracija u plazmi postignuta približno 1 sat nakon uzimanja lijeka.
The tablet core ingredients are: croscarmellose sodium, povidone K-30, colloidal anhydrous silica, magnesium stearate (E470b)
Sastojci u jezgri tablete su: umrežena karmelozanatrij, povidon K-30, bezvodni koloidni silicijev dioksid, magnezijev stearat (E470b).
Infections and infestations
Infekcije i infestacije Nazofaringiti s
Duration of treatment - Levetiracetam Accord is used as a chronic treatment.
• Levetiracetam Accord se koristi za kronično liječenje.
Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function
Prilagođavanje doze za odrasle bolesnike i adolescente tjelesne težine više od 50 kg s oštećenom bubrežnom funkcijom:
Swallow Levetiracetam Accord with a sufficient quantity of liquid (e.g. a glass of water).
Progutajte Levetiracetam Accord tablete s dovoljnom količinom tekućine (npr. s čašom vode).
Warnings and precautions Talk to your doctor before taking Levetiracetam Accord - If you suffer from kidney problems, follow your doctor's instructions.
Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Levetiracetam Accord
Do not take Levetiracetam Accord - If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na levetiracetam, derivate pirolidona ili neki drugi sastojak ovog lijeka
Levetiracetam has been given to you by your doctor to reduce the number of fits.
Vaš liječnik Vam je propisao levetiracetam kako bi se smanjio broj napadaja
What Levetiracetam Accord contains:
Levetiracetam Accord se koristi:
• suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking,
• samoubojstvo, poremećaj osobnosti (problemi u ponašanju), poremećaj mišljenja (sporo razmišljanje, nemogućnost koncentriranja);
Two embryo-foetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg /kg/day.
Provedene su dvije studije embrio-fetalnog razvoja (engl. embryo-fetal development, EFD) u štakora s dozama od 400, 1200 i 3600 mg/kg/dan.
Levetiracetam Accord film-coated tablets 250 mg, 500 mg, 750 mg and 1000 mg are packed in PVC-Alu blister pack.
Levetiracetam Accord filmom obložene tablete 250 mg, 500 mg, 750 mg i 1000 mg se pakiraju u PVC-Al blister pakiranja.
Six-month seizure freedom was achieved in 73.0% of levetiracetam-treated patients and 72.8% of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2%
73,0% bolesnika liječenih levetiracetamom i 72,8% bolesnika liječenih karbamazepinom s kontroliranim otpuštanjem (CR) bilo je šest mjeseci bez napadaja: prilagođena apsolutna razlika između liječenja bila je 0,2% (95% CI: -7,8 8,2).
In paediatric patients (1 month to less than 4 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 116 patients and had a treatment duration of 5days.
U pedijatrijskih bolesnika (1 mjesec do manje od 4 godine života), djelotvornost levetiracetama dokazana je dvostruko-slijepom i placebom kontroliranom studijom u 116 bolesnika, koji su lijek dobivali 5 dana.
• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination,
• pokušaj samoubojstva i suicidalne misli, mentalni poremećaj, poremećaj ponašanja,
Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia,disturbance in attention
Amnezija, smetnje pamćenja, poremećaji koordinacije/ataksija, parestezija, smetnje u koncentraciji
Acute Kidney injury
Akutno oštećenje bubrega
Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/kg/day (x6-17 the MRHD on a mg/m2 basis).
Neonatalne i juvenilne studije na štakorima i psima pokazale su da nema nuspojava u uobičajenim mjerama ishoda razvoja ili sazrijevanja kod primjene doza do 1800 mg/kg/dan (6-erostruka do 17erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m2).
In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1000 mg, 2000 mg, or 3000 mg /day, given in 2 divided doses, with a treatment duration of up to 18 weeks.
Djelotvornost levetiracetama dokazana je u odraslih u 3 dvostruko slijepe i placebom kontrolirane studije gdje su bolesnici tokom liječenja 18 tjedana dobivali 1000 mg, 2000 mg ili 3000 mg/dan, podjeljeno na dvije doze.
In paediatric patients (4 to 16 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 198 patients and had a treatment duration of 14 weeks.
U pedijatrijskih bolesnika (4. do 16. godina života) djelotvornost levetiracetama dokazana je u dvostruko-slijepoj i placebom kontroliranoj studiji koja je trajala 14 dana i uključivala 198 bolesnika.
• in the treatment of partial onset seizures with or without secondary generalisation in adults,adolescents, children and infants from 1 month of age with epilepsy.
• u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od 1. mjeseca života s epilepsijom.
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
• puno teži oblik osipa koji uzrokuje ljuštenje kože u više od 30 % površine tijela (toksična epidermalna nekroliza)znakove ozbiljnih mentalnih promjena ili ako netko oko vas primijeti kod vas znakove smetenosti, izrazitu pospanost, amneziju (gubitak pamćenja), slabljenje pamćenja (zaboravljivost), abnormalno ponašanje ili druge neurološke znakove uključujući nevoljne ili nekontrolirane pokrete.
Depression, hostility/ aggression, anxiety, insomnia, nervousness/irritabi lity
Depresija, netrpeljivost/ agresivnost, anksioznost, nesanica, nervoza/razdražljivost
Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Dodatna terapija za odrasle (≥18 godina) i adolescente (12 do 17 godina) tjelesne težine 50 kg ili više
43.6% of the levetiracetam treated patients and 19.6% of the patients on placebo were considered as responders.
Ocijenjeno je da je na liječenje odgovorilo 43,6% bolesnika koji su uzimali levetiracetam i 19,6% onih koji su uzimali placebo.
44.6% of the levetiracetam treated patients and 19.6% of the patients on placebo had a 50% or greater reduction from baseline in the partial onset seizure frequency per week.
U 44,6% bolesnika liječenih levetiracetamom i 19,6% bolesnika, koji su dobivali placebo zapaženo je 50 %-tno ili više smanjenje od početne učestalosti parcijalnih napadaja tjedno.
Levetiracetam is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Levetiracetam je indiciran kao monoterapija u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih i adolescenata od 16. godine života s novodijagnosticiranom epilepsijom.
Single pack containing 10, 20, 30, 50, 60, 100, 200 tablets.
Jedno pakiranje sadrži 10, 20, 30, 50, 60, 100, 200 tableta.
You should continue Levetiracetam Accord treatment for as long as your doctor has told you.
Accordom onoliko dugo koliko je liječnik odredio.
The NOAEL was ≥ 1800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis).
NOAEL je iznosila ≥ 1800 mg/kg/dan za F0 ženke te za preživljenje, rast i razvoj za F1 potomstvo do odbića (6-erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m2).
How to take Levetiracetam Accord
Kako uzimati Levetiracetam Accord
The blisters are further packed in to carton with leaflet in pack size of 10, 20, 30, 50, 60, 100 and 200 tablets per pack.
Blisteri se dalje pakiraju u kutije s Uputama o lijeku te sadrže 10, 20, 30, 50, 60, 100 i 200 tableta po pakiranju.
Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
• Doza u dojenčadi (1 mjesec do 23 mjeseca), djece (2 do 11 godina) i adolescenata (12 do 17 godina) koji imaju manje od 50 kg
As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg /kg/day levetiracetam.
Kako ni u odraslih, tako ni u pedijatrijskih bolesnika koji su dobivali do 60 mg/kg/dan levetiracetama, nema dokaza o klinički značajnim interakcijama s lijekovima.
Completed suicide,personality disorder, thinking abnormal, delirium
Počinjeno samoubojstvo, poremećaj osobnosti, poremećaj mišljenja, delirij
(4) Following dialysis, a 3.5 to 7 mg /kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
(4) Nakon dijalize preporučuje se dodatna doza od 3,5 do 7 mg/kg (0,035 do 0,07 ml/kg).
The NOAEL was <200 mg/kg/day for the dams and 200 mg/kg/day for the foetuses (equal to the MRHD on a mg/m2 basis).
NOAEL je za gravidne ženke iznosila <200 mg/kg/dan, a za fetuse 200 mg/kg/dan (što je jednako MRHD-u, Maximum Recommended Human Dose, izraženom u mg/m2).
Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
Reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS),
In several cases of alopecia, recovery was observed when levetiracetam was discontinued.Bone marrow suppression was identified in some of the cases of pancytopenia.
U nekoliko slučajeva alopecije utvrđen je oporavak nakon što je levetiracetam ukinut.
Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy
Dodatna terapija u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od 1. mjeseca života s epilepsijom.
Levetiracetam oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Oralna otopina levetiracetama je najprikladniji farmaceutski oblik za primjenu u dojenčadi i djece mlađe od 6 godina.
anger, confusion, panic attack,emotional instability/mood swings, agitation;
halucinacije, srditost, smetenost, napadaj panike, emocionalna nestabilnost/promjene raspoloženja, uznemirenost;
In vitro and in vivo experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission.
Mehanizam djelovanja levetiracetama nije u potpunosti razriješen.Eksperimenti in vitro i in vivo pokazuju da levetiracetam ne utječe na osnovna svojstva stanica i normalnu neurotransmisiju.
Levetiracetam Accord 250 mg film-coated tablets Levetiracetam Accord 500 mg film-coated tablets Levetiracetam Accord 750 mg film-coated tablets Levetiracetam Accord 1000 mg film-coated tablets
Levetiracetam Accord 250 mg filmom obložene tablete Levetiracetam Accord 500 mg filmom obložene tablete Levetiracetam Accord 750 mg filmom obložene tablete Levetiracetam Accord 1000 mg filmom obložene tablete
(5) Following dialysis, a 5 to 10 mg /kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
(5) Nakon dijalize preporučuje se dodatna doza od 5 do 10 mg/kg (0,05 do 0,10 ml/kg).
Iron oxide yellow (E172)
500 mg željezov oksid, žuti (E172)
Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Levetiracetam overdoses.
Kod predoziranja levetiracetama primijećena je somnolencija, agitacija, agresivnost, smanjena razina svijesti, depresija disanja i koma.
Choreoathetosis,d yskinesia, hyperkinesia, gait disturbance,
Koreoatetoza, diskinezija, hiperkinezija, poremećaji hodanja, encefalopatija
Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Film ovojnica polivinilni alkohol titanijev dioksid (E171) makrogol talk
750 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), sunset yellow FCF(E110)
poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, crveni željezov oksid (E 172), sunset yellow FCF (E110)
The NOAEL (No Observed Adverse Effect Level) was 3600 mg /kg/day for pregnant female rats (x 12 the MRHD on a mg/m2basis) and 1200 mg /kg/day for fetuses.
NOAEL (No Observed Adverse Effect Level, razina pri kojoj se ne uočava štetni učinak) za gravidne štakorice iznosila je 3600 mg/kg/dan, a za fetuse 1200 mg/kg/dan (12-erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m2).
In this study, levetiracetam, dose was 3000 mg /day given in 2 divided doses.
Primijenjena doza kod studije bila je 3000 mg/dan podjeljeno na dvije doze.
Add-on therapy for infants aged from 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
Dodatna terapija za dojenčad u dobi od 6. do 23. mjeseca, djecu (2 do 11 godina) i adolescente (12 do 17 godina) s manje od 50 kg tjelesne težine.
No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Kod mužjaka i ženki štakora roditeljske i F1 generacije nisu primijećene nuspojave na plodnost ili na reprodukciju u dozama do 1800 mg/kg/dan (6-erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m2 ili na osnovnu izloženosti).
How to store Levetiracetam Accord
Kako čuvati Levetiracetam Accord
With continued long-term treatment, 8.6% of the patients were seizure-free for at least 6 months and 7.8% were seizure-free for at least 1 year.
Dugoročno je liječenje pokazalo da 8,6% bolesnika nije imalo napadaje tijekom najmanje 6 mjeseci, a njih 7,8% nije imalo napadaje tijekom najmanje 1 godine.
Muscular weakness, myalgia Rhabdomyolysis and blood creatine tissue disorders phosphokinase increased*
Rabdomioliza i povišena kreatin fosfokinaza u krvi*
Colloidal anhydrous silica Magnesium Stearate (E470b)
Jezgra tablete karmelozanatrij, umrežena povidon K-30 silicijev dioksid, koloidni, bezvodni magnezijev stearat (E470b)
(3) A 15 mg /kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
(3) Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 15 mg/kg (0,15 ml/kg).
INFORMATION IN BRAILLE Levetiracetam Accord 1000 mg
Levetiracetam Accord 1000 mg
Accord Healthcare Limited Sage house, 319 Pinner road North Harrow HA1 4HF
Sage house, 319 Pinner Road,
For 1000mg:
Za 1000 mg:
Dose in adults and adolescents (from 16 years of age) General dose: between 1000 mg and 3,000 mg each day.
Uobičajena doza: između 1000 mg i 3000 mg svaki dan.
Levetiracetam Accord 750 mg film-coated tablets Pink coloured, oval, biconvex, debossed ‘L 66' and break line on one side and plain on the other side.
Levetiracetam Accord 750 mg filmom obložene tablete Ružičasta, ovalna, bikonveksna s utisnutom oznakom „L 66” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
Thrombocytopenia, leukopenia Pancytopenia, neutropenia, agranulocytosis
Trombocitopenija, leukopenija
1000 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc
1000 mg: poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk