natgillin/translations-raw huggingface dataset:
The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness.
Najčešće prijavljene nuspojave su nazofaringitis, somnolencija (pospanost), glavobolja, umor i omaglica.
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 do 23 mjeseca), djece (2 do 11 godina) i adolescenata (12 do 17 godina) koji imaju manje od 50 kg:
Levetiracetam Actavis 750 mg tablets contain Sunset Yellow (E110)
Levetiracetam Actavis 750 mg tablete sadrže sunset yellow (E110)
Levetiracetam Actavis 250 mg, 500 mg and 1,000 mg film-coated tablets Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Levetiracetam Actavis 250 mg, 500 mg i 1000 mg filmom obložene tablete Blisteri: 20, 30, 50, 60, 100, 120 i 200 filmom obloženih tableta.
• If you suffer from kidney problems, follow your doctor's instructions.
• Ako patite od bubrežnih problema, slijedite upute svog liječnika koji će odlučiti treba li prilagoditi Vašu dozu.
Dosing adjustment for infants, children and adolescents patients weighing less than 50 kg with impaired renal function
Prilagođavanje doze kod dojenčadi, djece i adolescenata s manje od 50 kg tjelesne težine s oštećenom bubrežnom funkcijom
Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Veličine pakiranja: Blisteri: 20, 30, 50, 60, 100, 120 i 200 filmom obloženih tableta.
With continued long-term treatment, 47.4 % of the patients were free of tonic-clonic seizures for at least 6 months and 31.5 % were free of tonic-clonic seizures for at least 1 year.
S nastavkom dugotrajnog liječenja 47,4% bolesnika bilo je barem 6 mjeseci i 31,5% barem 1 godinu bez toničko-kloničkih napadaja.
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 1,800 mg/kg/day (x 6 - 17 the MRHD on a mg/m2 basis).
Neonatalna i juvenilna ispitivanja na štakorima i psima pokazala 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).
• partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age;
parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od prvog mjeseca života;
Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Amnezija, smetnje pamćenja, poremećaji koordinacije/ataksija, parestezije, smetnje u koncentraciji
(1) An 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.
(1) Za doze ispod 250 mg i za višestruke doze od 250 mg kada se preporuka o doziranju ne postiže uzimanjem više tableta i kod bolesnika koji ne mogu gutati tablete treba koristiti oralnu otopinu.
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
Oral absolute bioavailability is close to Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing.
Vršna koncentracija u plazmi (Cmax) postiže se 1,3 sata nakon uzimanja lijeka.
Contains colouring agent sunset yellow (E110).
Sadrži bojilo sunset yellow (E 110).
Crospovidon, povidone, silica colloidal anhydrous, magnesium stearate, polyvinyl alcohol-part. hydrolyzed, macrogol 4000, talc, titanium dioxide (E171), colourants*.
Drugi sastojci su: krospovidon, povidon, bezvodni koloidni silicijev dioksid, magnezijev stearat, djelomično hidrolizirani polivinilni alkohol, makrogol 4000, talk, titanijev dioksid (E171), bojila*.
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function;
• simptome kao što je smanjen volumen mokraće, umor, mučninu, povraćanje, smetenost i oticanje u nogama, gležnjevima ili stopalima jer to može biti znak naglog smanjenja bubrežne funkcije • kožni osip koji može tvoriti mjehure i izgledati poput malih meta (središnje tamne mrlje okružene svijetlim područjem, s tamnim prstenom oko ruba) (multiformni eritem)
How to take Levetiracetam Actavis
Kako uzimati Levetiracetam Actavis
Levetiracetam Actavis 750 mg film-coated tablets Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Levetiracetam Actavis 750 mg filmom obložene tablete Blisteri: 20, 30, 50, 60, 100, 120 i 200 filmom obloženih tableta.
20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 120 film-coated tablets 200 film-coated tablets 60 x 1 film-coated tablets
20 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta 120 filmom obloženih tableta 200 filmom obloženih tableta 60 x 1 filmom obloženih tableta
With continued longterm treatment, 11.4 % of the patients were seizure-free for at least 6 months and 7.2 % were seizurefree for at least 1 year.
S nastavkom dugotrajnog liječenja 11,4% bolesnika bilo je barem 6 mjeseci, a 7,2% barem 1 godinu bez napadaja.
An oral solution is the preferred formulation for use in this population.
Najprikladniji farmaceutski oblik za primjenu u toj populaciji je oralna otopina.
In both population pharmacokinetic analyses, there was about a 20 % increase of apparent clearance of levetiracetam when it was co-administered with an enzyme-inducing antiepileptic medicinal product.
U obje farmakokinetičke analize populacije prividni klirens levetiracetama se povećao za oko 20%
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, engl.
Quincke's oedema [swelling of the face, lips, tongue and throat]);
Quinckeov edem [oticanje lica, usana, jezika i grla]); • snižena koncentracija natrija u krvi;
30 film-coated tablets 100 film-coated tablets 200 film-coated tablets
30 filmom obloženih tableta 100 filmom obloženih tableta 200 filmom obloženih tableta
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 djelomičnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od 1. mjeseca života nadalje koji pate od epilepsije.
Levetiracetam Actavis 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 Actavis 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.
750 mg tablet: Indigo carmine (E132), sunset yellow (E110), iron oxide red (E172).
500 mg tableta: žuti željezov oksid (E172), indigo carmine (E132). 750 mg tableta: indigo carmine (E132), sunset yellow (E110), crveni željezov oksid (E 172).
With continued long-term treatment, 8.6 % of the patients were seizurefree 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.
An oral solution is the formulation to use in infants.
Oralna otopina je oblik za primjenu kod dojenčadi.
Weight decreased, weight increase
povećanje tjelesne težine
20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 120 film-coated tablets 200 film-coated tablets
20 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta 120 filmom obloženih tableta 200 filmom obloženih tableta
• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
• konvulzije, poremećaj ravnoteže, omaglica (osjećaj nestabilnosti), bezvoljnost (gubitak energije i entuzijazma), tremor (nevoljno drhtanje);
(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)
In the elderly, the half-life is increased by about 40 % (10 to 11 hours).
U starijih osoba poluvijek u plazmi povećano je za oko 40% (10 do 11 sati), što je u svezi sa smanjenjem bubrežne funkcije unutar te populacije (vidjeti dio 4.2).
One tablet of Levetiracetam Actavis 1,000 mg contains 1,000 mg of levetiracetam.
Jedna tableta Levetiracetama Actavis 1000 mg sadrži 1000 mg levetiracetama.
How to store Levetiracetam Actavis
Kako čuvati Levetiracetam Actavis
in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
• u liječenju miokloničkih napadaja u odraslih i adolescenata od 12. godine života s juvenilnom miokloničnom epilepsijom.
(4) Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
Nakon dijalize preporučuje se dodatna doza od 3,5 do 7 mg/kg (0,035 do 0,07 ml/kg)
Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behaviour Checklist).
Rezultati ocjene funkcioniranja ponašanja i emocionalnog funkcioniranja uputili su na pogoršanje u smislu agresivnijeg ponašanja u skupini koja je uzimala levetiracetam, ocijenjenog validiranim instrumentom
One tablet of Levetiracetam Actavis 250 mg contains 250 mg of levetiracetam.
Jedna tableta Levetiracetama Actavis 250 mg sadrži 250 mg levetiracetama.
One tablet of Levetiracetam Actavis 500 mg contains 500 mg of levetiracetam.
Jedna tableta Levetiracetama Actavis 500 mg sadrži 500 mg levetiracetama.
Normal Mild Moderate
Blago oštećenje Umjereno oštećenje
10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily (3) (5)
10 do 20 mg/kg (0,10 do 0,20 ml/kg) jednaput na dan (3) (5)
With continued long-term treatment, 28.6% of the patients were free of myoclonic seizures for at least 6 months and 21.0 % were free of myoclonic seizures for at least 1 year.
28,6% bolesnika bilo je barem 6 mjeseci i 21,0% barem 1 godinu bez miokloničkih napadaja.
One tablet of Levetiracetam Actavis 750 mg contains 750 mg of levetiracetam.
Jedna tableta Levetiracetama Actavis 750 mg sadrži 750 mg levetiracetama.
Levetiracetam Actavis 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam.
Levetiracetam Actavis 250 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 250 mg levetiracetama.
The NOAEL (No Observed Adverse Effect Level) was 3,600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2
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).
Each film-coated tablet contains 1,000 mg levetiracetam.
Jedna filmom obložena tableta sadrži 1000 mg levetiracetama.
Swallow Levetiracetam Actavis tablets with a sufficient quantity of liquid (e.g. a glass of water).
Način primjene Progutajte Levetiracetam Actavis tablete s dovoljnom količinom tekućine (npr. s čašom vode).Levetiracetam Actavis možete uzeti s hranom ili bez nje.
Islande / Island Tel: +354 550 3300
Actavis Group PTC ehf. Islande / Island Tel: +354 550 3300
The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Ti podaci dopunjeni su podacima iz odgovarajućih ispitivanja otvorenog produžetka o primjeni levetiracetama, kao i postmarketinškim iskustvima Sigurnosni profil levetiracetama uglavnom je sličan u svim starosnim skupinama (odrasli i pedijatrijski bolesnici) i u svim odobrenim indikacijama epilepsije.
Levetiracetam Actavis 500 mg film-coated tablets Oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side.
Levetiracetam Actavis 500 mg filmom obložene tablete su ovalne, žute tablete, veličine 17,1 x 8,1 mm s oznakom „L” na jednoj strani i „500“ na drugoj strani.
Levetiracetam Actavis 250 mg film-coated tablets are oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and “250” on the other side.
Levetiracetam Actavis 250 mg filmom obložene tablete su ovalne, svijetloplave tablete, veličine 13,6 x 6,4 mm, s oznakom „L” na jednoj strani i „250“ na drugoj strani.
Levetiracetam Actavis 750 mg film-coated tablets Oval, orange 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side.
Levetiracetam Actavis 750 mg filmom obložene tablete su ovalne, narančaste tablete, veličine 19,0 x 9,3 mm s oznakom „L” na jednoj strani i „750“ na drugoj strani.
Each tablet contains 1,000 mg levetiracetam.
Jedna tableta sadrži 1000 mg levetiracetama.
Ca currents and by reducing the release of Ca from intraneuronal stores.
N-tip protoka Ca2+ i smanjuje otpuštanje Ca2+ iz skladišta u neuronima.
The patients were randomized to carbamazepine CR 400--1,200 mg/day or levetiracetam 1,000--3,000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Bolesnici su randomizirani za dobivanje 400 do 1200 mg karbamazepina s kontroliranim otpuštanjem (CR) na dan ili 1000 do 3000 mg levetiracetama na dan,
Perforated unit dose blisters: EU/1/11/713/043 60 x 1 tablets
Perforirani blisteri djeljivi na jedinične doze: EU/1/11/713/043 60 x 1 tableta
Levetiracetam Actavis 1,000 mg film-coated tablets Oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side.
Levetiracetam Actavis 1000 mg filmom obložene tablete su ovalne, bijele tablete, veličine 19,0 x 10,0 mm s oznakom „L” na jednoj strani i „1000“ na drugoj strani.
Levetiracetam Actavis 1,000 mg tablets Levetiracetam
Levetiracetam Actavis 1000 mg tablete levetiracetam
Perforated unit dose blisters: EU/1/11/713/042 60 x 1 tablets
Perforirani blisteri djeljivi na jedinične doze: EU/1/11/713/042 60 x 1 tableta
Each tablet contains 750 mg levetiracetam.
Jedna tableta sadrži 750 mg levetiracetama.
Levetiracetam Actavis 1,000 mg film-coated tablets
Levetiracetam Actavis 1 000 mg filmom obložene tablete
The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily.
mg dva puta na dan uz maksimalnu dozu od 750 mg dva puta na dan.
250 to 500 mg twice daily
250 do 500 mg dva puta na dan 500 do 1000 mg jedanput na dan (2)
Each film-coated tablet contains 750 mg levetiracetam.
Jedna filmom obložena tableta sadrži 750 mg levetiracetama.
Perforated unit dose blisters: EU/1/11/713/041 60 x 1 tablets
Perforirani blisteri djeljivi na jedinične doze: EU/1/11/713/041 60 x 1 tableta
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 1,000 mg film-coated tablets
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blisteri za filmom obložene tablete od 1000 mg
Each tablet contains 500 mg levetiracetam.
Jedna tableta sadrži 500 mg levetiracetama.
Levetiracetam Actavis 1,000 mg tablets are oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side.
Ovalna, bijela tableta, veličine 19,0 x 10,0 mm s oznakom „L” na jednoj strani i „1000“ na drugoj strani.
Levetiracetam Actavis 250 mg tablets Levetiracetam
Levetiracetam Actavis 250 mg tablete levetiracetam
Excretion via faeces accounted for only 0.3 % of the dose.
Samo 0,3% doze izlučuje se fecesom.
EU/1/11/713/018 30 tablets EU/1/11/713/019 100 tablets EU/1/11/713/020 200 tablets
EU/1/11/713/018 30 tableta EU/1/11/713/019 100 tableta EU/1/11/713/020 200 tableta
Each tablet contains 250 mg levetiracetam.
Jedna tableta sadrži 250 mg levetiracetama.
Levetiracetam Actavis 750 mg tablets Levetiracetam
Levetiracetam Actavis 750 mg tablete levetiracetam
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 750 mg film-coated tablets
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blisteri za filmom obložene tablete od 750 mg
Each film-coated tablet contains 500 mg levetiracetam.
Jedna filmom obložena tableta sadrži 500 mg levetiracetama.
Each film-coated tablet contains 250 mg levetiracetam.
Jedna filmom obložena tableta sadrži 250 mg levetiracetama.
Levetiracetam Actavis 500 mg tablets Levetiracetam
Levetiracetam Actavis 500 mg tablete levetiracetam
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 250 mg film-coated tablets
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blisteri za filmom obložene tablete od 250 mg
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.
Levetiracetam Actavis 750 mg tablets are oval, orange, 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side.
Ovalna, narančasta tableta, veličine 19,0 x 9,3 mm s oznakom „L” na jednoj strani i „750“ na drugoj strani.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 500 mg film-coated tablets
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blisteri za filmom obložene tablete od 500 mg
EU/1/11/713/008 30 tablets EU/1/11/713/009 100 tablets EU/1/11/713/010 200 tablets
EU/1/11/713/008 30 tableta EU/1/11/713/009 100 tableta EU/1/11/713/010 200 tableta
EU/1/11/713/028 30 tablets EU/1/11/713/029 100 tablets EU/1/11/713/030 200 tablets
EU/1/11/713/028 30 tableta EU/1/11/713/029 100 tableta EU/1/11/713/030 200 tableta
Levetiracetam Actavis 500 mg tablets are oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side.
Ovalna, žuta tableta, veličine 17,1 x 8,1 mm s oznakom „L” na jednoj strani i „500“ na drugoj strani.
Infants 6 to 23 months, children and adolescents weighing less than 50 kg
djeca i adolescenti teški manje od 50 kg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 1,000 mg film-coated tablets in tablet containers
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za spremnike s filmom obloženim tabletama od 1000 mg
EU/1/11/713/038 30 tablets EU/1/11/713/039 100 tablets EU/1/11/713/040 200 tablets
EU/1/11/713/038 30 tableta EU/1/11/713/039 100 tableta EU/1/11/713/040 200 tableta
Levetiracetam Actavis 750 mg film-coated tablets
Levetiracetam Actavis 750 mg filmom obložene tablete
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 1,000 mg film-coated tablets in tablet containers
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na spremnicima s filmom obloženim tabletama od 1000 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 250 mg film-coated tablets in tablet containers
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za spremnike s filmom obloženim tabletama od 250 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 750 mg film-coated tablets in tablet containers
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za spremnike s filmom obloženim tabletama od 750 mg
Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment.
Opisani su rijetki slučajevi smanjenog broja krvnih stanica (neutropenija, agranulocitoza, leukopenija,
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 750 mg film-coated tablets in tablet containers
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na spremnicima s filmom obloženim tabletama od 750 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 500 mg film-coated tablets in tablet containers
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za spremnike s filmom obloženim tabletama od 500 mg
EU/1/11/713/001 20 tablets EU/1/11/713/002 30 tablets EU/1/11/713/003 50 tablets EU/1/11/713/004 60 tablets EU/1/11/713/005 100 tablets EU/1/11/713/006 120 tablets EU/1/11/713/007 200 tablets
EU/1/11/713/001 20 tableta EU/1/11/713/002 30 tableta EU/1/11/713/003 50 tableta EU/1/11/713/004 60 tableta EU/1/11/713/005 100 tableta EU/1/11/713/006 120 tableta EU/1/11/713/007 200 tableta
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 250 mg film-coated tablets in tablet containers
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na spremnicima s filmom obloženim tabletama od 250 mg
Levetiracetam Actavis 500 mg film-coated tablets
Levetiracetam Actavis 500 mg filmom obložene tablete
Silica colloidal anhydrous Magnesium stearate Polyvinyl alcohol - part. hydrolyzed Macrogol 4000
Levetiracetam Actavis 1,000 mg filmom obložene tablete krospovidon povidon silicijev dioksid, koloidni, bezvodni magnezijev stearat polivinilni alkohol - djelomično hidroliziran makrogol 4000 talk titanijev dioksid (E171)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 500 mg film-coated tablets in tablet containers
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na spremnicima s filmom obloženim tabletama od 500 mg
EU/1/11/713/021 20 tablets EU/1/11/713/022 30 tablets EU/1/11/713/023 50 tablets EU/1/11/713/024 60 tablets EU/1/11/713/025 100 tablets EU/1/11/713/026 120 tablets EU/1/11/713/027 200 tablets
EU/1/11/713/021 20 tableta EU/1/11/713/022 30 tableta EU/1/11/713/023 50 tableta EU/1/11/713/024 60 tableta EU/1/11/713/025 100 tableta EU/1/11/713/026 120 tableta EU/1/11/713/027 200 tableta
Levetiracetam Actavis 1,000 mg film-coated tablets Levetiracetam
Levetiracetam Actavis 1000 mg filmom obložene tablete levetiracetam
EU/1/11/713/011 20 tablets EU/1/11/713/012 30 tablets EU/1/11/713/013 50 tablets EU/1/11/713/014 60 tablets EU/1/11/713/015 100 tablets EU/1/11/713/016 120 tablets EU/1/11/713/017 200 tablets
EU/1/11/713/011 20 tableta EU/1/11/713/012 30 tableta EU/1/11/713/013 50 tableta EU/1/11/713/014 60 tableta EU/1/11/713/015 100 tableta EU/1/11/713/016 120 tableta EU/1/11/713/017 200 tableta
EU/1/11/713/031 20 tablets EU/1/11/713/032 30 tablets EU/1/11/713/033 50 tablets EU/1/11/713/034 60 tablets EU/1/11/713/035 100 tablets EU/1/11/713/036 120 tablets EU/1/11/713/037 200 tablets
EU/1/11/713/031 20 tableta EU/1/11/713/032 30 tableta EU/1/11/713/033 50 tableta EU/1/11/713/034 60 tableta EU/1/11/713/035 100 tableta EU/1/11/713/036 120 tableta EU/1/11/713/037 200 tableta
Description of selected adverse reactions
Opći poremećaji i reakcije na mjestu primjene
in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
• u liječenju primarno generaliziranih toničko-kloničkih napadaja u odraslih i adolescenata od 12.
Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam
Levetiracetam Actavis 500 mg filmom obložene tablete levetiracetam
Serum Creatinine (mg/dl)
Maximum Recommended Human Dose, izraženom u mg/m2).
България Актавис ЕАД
Varvara Atena
Titanium dioxide (E171) Indigo carmine (E132) Sunset yellow (E110) Iron oxide red (E172)
Levetiracetam Actavis 750 mg filmom obložene tablete krospovidon povidon silicijev dioksid, koloidni, bezvodni magnezijev stearat polivinilni alkohol - djelomično hidroliziran makrogol 4000 talk titanijev dioksid (E171) indigo carmine (E132) sunset yellow (E110) crveni željezov oksid (E172)
7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily
7 do 14 mg/kg (0,07 do 0,14 ml/kg) jedanput na dan (2) (4)
Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam
Levetiracetam Actavis 750 mg filmom obložene tablete levetiracetam