natgillin/translations-raw huggingface dataset:
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
500 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172) 
500 mg: poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, žuti željezov oksid (E 172)
Levetiracetam oral solution is the preferred formulation for use in this population. 
Najprikladniji farmaceutski oblik za primjenu u toj populaciji je oralna otopina levetiracetama.
(2) A 10.5 mg /kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam. 
(2) Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 10,5 mg/kg (0,105 ml/kg).
For 250mg: 
Za 250 mg:
INFORMATION IN BRAILLE Levetiracetam Accord 750 mg 
Levetiracetam Accord 750 mg
250 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc 
250 mg: poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk
7 to 21 mg /kg (0.07 to 0.21 ml/kg) twice daily 
7 do 21 mg/kg (0,07 do 0,21 ml/kg) dva puta na dan
INFORMATION IN BRAILLE Levetiracetam Accord 250 mg 
Levetiracetam Accord 250 mg
NAME OF THE MEDICINAL PRODUCT Levetiracetam Accord 500 mg film-coated tablets Levetiracetam 
NAZIV GOTOVOG LIJEKA Levetiracetam Accord 500 mg filmom obložene tablete levetiracetam
The active ingredient is levetiracetam. 
Što Levetiracetam Accord sadrži Djelatna tvar je levetiracetam.
3.5 to 7 mg /kg (0.035 to 0.07 ml/kg) twice daily 
3,5 do 7 mg/kg (0,035 do 0,07 ml/kg) dva puta na dan
For 500mg: 
Za 500 mg:
For 750mg: 
Za 750 mg:
INFORMATION IN BRAILLE Levetiracetam Accord 500 mg 
Levetiracetam Accord 500 mg
Levetiracetam Accord 500 mg film-coated tablets Yellow coloured, oval, biconvex, debossed ‘L 65' and break line on one side and plain on the other side. 
Levetiracetam Accord 500 mg filmom obložene tablete Žuta, ovalna, bikonveksna s utisnutom oznakom „L 65” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
Levetiracetam Accord 1000 mg film-coated tablets White to off white, oval, biconvex, debossed ‘L 67' and break line on one side and plain on the other side. 
Levetiracetam Accord 1000 mg filmom obložene tablete Bijela do gotovo bijela, ovalna, bikonveksna s utisnutom oznakom „L 67” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
Hyponatraemia 
Monoterapija
Levetiracetam Accord 750 mg film-coated tablets Each film-coated tablet contains 750 mg levetiracetam 
Levetiracetam Accord 750 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 750 mg levetiracetama.
10 to 20 mg /kg (0.10 to 0.20 ml/kg) twice daily 
10 do 20 mg/kg (0,10 do 0,20 ml/kg) dva puta na dan
Levetiracetam Accord 750 mg film-coated tablets Levetiracetam 
Levetiracetam Accord 750 mg filmom obložene tablete levetiracetam
Levetiracetam Accord 500 mg film-coated tablets Each film-coated tablet contains 500 mg levetiracetam 
Levetiracetam Accord 500 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 500 mg levetiracetama.
5 to 15 mg /kg (0.05 to 0.15 ml/kg) twice daily 
5 do 15 mg/kg (0,05 do 0,15 ml/kg) dva puta na dan
10 to 30 mg /kg (0.10 to 0.30 ml/kg) twice daily 
10 do 30 mg/kg (0,10 do 0,30 ml/kg) dva puta na dan
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PVC-Al blister
7 to 14 mg /kg (0.07 to 0.14 ml/kg) twice daily 
7 do 14 mg/kg (0,07 do 0,14 ml/kg) dva puta na dan
MINIMUMPARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PVC/Al blister pakiranje
Levetiracetam Accord 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam 
Levetiracetam Accord 250 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 250 mg levetiracetama.
3.5 to 10.5 mg /kg (0.035 to 0.105 ml/kg) twice daily 
3,5 do 10,5 mg/kg (0,035 do 0,105 ml/kg) dva puta na dan
White to off white, oval, biconvex, film coated tablet, debossed ‘L 67' and break line on one side and plain on the other side. 
Bijela do gotovo bijela, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 67” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
5 to 10 mg /kg (0.05 to 0.10 ml/kg) twice daily 
5 do 10 mg/kg (0,05 do 0,10 ml/kg) dva puta na dan
Levetiracetam Accord 1000 mg film-coated tablet Levetiracetam 
Levetiracetam Accord 1000 mg filmom obložene tablete levetiracetam
- If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor - A small number of people being treated with anti-epileptics such as Levetiracetam Accord have had thoughts of harming or killing themselves. 
• ako primijetite usporen rast ili neočekivan razvoj djeteta u pubertetu, obavijestite svog liječnika.
White to off white, oval, biconvex, film coated tablet, debossed ‘L 64' and break line on one side and plain on the other side. 
Bijela do gotovo bijela, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 64” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
Add-on therapy for infants aged from 1 month to less than 6 months The oral solution is the formulation to use in infants. 
Dodatna terapija za dojenčad u dobi od 1 mjeseca do manje od 6 mjeseci
Yellow coloured, oval, biconvex, film coated tablet, debossed ‘L 65' and break line on one side and plain on the other side. 
Žuta, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 65” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
Pink coloured, oval, biconvex, film coated tablet, debossed ‘L 66' and break line on one side and plain on the other side. 
Ružičasta, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 66” i razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.
7 to 14 mg /kg (0.07 to 0.14 ml/kg)once daily (2) 
7 do 14 mg/kg (0,07 do 0,14 ml/kg) jedanput na dan
Levetiracetam Accord 1000 mg film-coated tablets Each film-coated tablet contains 1000 mg levetiracetam 
Levetiracetam Accord 1000 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 1000 mg levetiracetama.
Levetiracetam Accord 500 mg film-coated tablet Levetiracetam 
Levetiracetam Accord 500 mg filmom obložene tablete levetiracetam
Musculoskeletal and connective 
Poremećaji mišićnokoštanog sustava i vezivnog tkiva
EU/1/11/712/001-007 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/029-031(30/60/100 tablets in Unit dose Blister) 
EU/1/11/712/001-007 (10/20/30/50/60/100/200 tableta u PVC/Al blisteru) EU/1/11/712/029-031 (30/60/100 tableta u blisteru djeljivom na jedinične doze)
Levetiracetam Accord 250 mg film-coated tablets Levetiracetam 
Levetiracetam Accord 250 mg filmom obložena tableta levetiracetam
EU/1/11/712/015-021 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/035-037 (30/60/100tablets in Unit dose Blister) 
EU/1/11/712/015-021 (10/20/30/50/60/100/200 tableta u PVC/Al blisteru) EU/1/11/712/035-037 (30/60/100 tableta u blisteru djeljivom na jedinične doze)
EU/1/11/712/008-014 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/032-034 (30/60/100tablets in Unit dose Blister) 
EU/1/11/712/008-014 (10/20/30/50/60/100/200 tableta u PVC/Al blisteru) EU/1/11/712/032-034 (30/60/100 tableta u blisteru djeljivom na jedinične doze)
EU/1/11/712/022-028 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/038-040(30/60/100tablets in Unit dose Blister) 
EU/1/11/712/022-028 (10/20/30/50/60/100/200 tableta u PVC/Al blisteru) EU/1/11/712/038-040 (30/60/100 tableta u blisteru djeljivom na jedinične doze)
Levetiracetam Accord may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. 
Ako vozite ili upravljate alatima ili vozilima potreban je oprez jer se pri uzimanju lijeka Levetiracetam Accord može javiti osjećaj pospanosti.
Iron oxide red (E172) Sunset yellow FCF (E110) 6.2 Incompatibilities Not applicable. 
sunset yellow FCF (E110)
Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more General dose: between 1,000 mg and 3,000 mg each day. 
• Doza u odraslih i adolescenata (12 do 17 godina) koji imaju 50 kg ili više:
Levetiracetam Accord 250 mg film-coated tablets 
Levetiracetam Accord 250 mg filmom obložene tablete levetiracetam
10 to 20 mg /kg (0.10 to 
10 do 20 mg/kg (0,10 do 0,20 ml/kg) jednaput na dan
--1 Live attenuated avian infectious bronchitis virus (IBV), variant strain 4-91: ≥3.6 log10 EID50* per dose * EID50: 50% embryo infective dose - the virus titre required to produce infection in 50% of the embryos inoculated. 
--1 Živi, atenuirani virus zaraznog bronhitisa kokoši (ZBK), varijantni soj 4-91: ≥ 3,6 log 10 EID50 po dozi * EID50 = 50% Embrijo infektivna doza: titar virusa koji prouzroci infekciju u 50% virusom inokuliranih embrija
1 Bottle 
1 bočica
3 Bottles 
3 bočice
MA (EU) number (Invented) name Strength Pharmaceutical Form 
Zaštićeno ime Doza Farmaceutski oblik
If so, treatment should be stopped immediately. 
Ako se to dogodi, liječenje treba odmah prekinuti.
After 3 weeks a break of at least 2 weeks is required. 
Nakon 3 tjedna primjene potrebna je pauza od najmanje 2 tjedna.
This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU. 
To znači da postoje bibliografski podaci koji pružaju znanstvene dokaze o njihovoj učinkovitosti i sigurnoj uporabi kada se koriste na opisani način, tijekom razdoblja od najmanje 10 godina u EU-u.
In rare cases allergic skin reactions can occur. 
U rijetkim slučajevima mogu nastupiti alergijske reakcije kože.