natgillin/translations-raw huggingface dataset:
Add-on therapy for infants aged from 1 month to less than 6 months The oral solution is the formulation to use in infants.
Dopolnilno zdravljenje za dojenčke stare od 1 do manj kot 6 mesecev Farmacevtska oblika, ki je prilagojena za uporabo pri tej skupini, je peroralna raztopina.
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.
Za otroke, stare 6 let in več, se mora pri odmerkih, manjših od 250 mg, pri odmerkih, ki niso večkratniki od 250 mg in zato priporočenega odmerjanja ni mogoče doseči z več tabletami in pri bolnikih, ki ne morejo požirati tablet, uporabiti zdravilo Levetiracetam v obliki peroralne raztopine.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJE
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.
V tej študiji so pri dojenčkih, od 1. meseca do manj kot 6. meseca starosti, uporabljali odmerek 20 mg/kg/dan titriran do 40 mg/kg/dan, za dojenčke in otroke, od 6. meseca do manj kot 4. leta starosti, pa odmerek 25 mg/kg/dan, titriran do 50 mg/kg/dan.
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.
Zdravilo Levetiracetam Accord je indicirano za samostojno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih in mladostnikih od 16. leta starosti z na novo diagnosticirano epilepsijo.
Contains sunset yellow (E110).
SEZNAM POMOŽNIH SNOVI Vsebuje sončno rumena (E110).
Duration of treatment - Levetiracetam Accord is used as a chronic treatment.
• Zdravilo Levetiracetam Accord se uporablja za dolgotrajno zdravljenje.
Colloidal anhydrous silica Magnesium Stearate (E470b)
premreženi natrijev karmelozat povidon K-30 brezvodni koloidni silicij magnezijev stearat (E470b)
What you need to know before you take Levetiracetam Accord
Kaj morate vedeti, preden boste vzeli zdravilo Levetiracetam Accord Ne jemljite zdravila Levetiracetam Accord
Levetiracetam is indicated as adjunctive therapy
Zdravilo Levetiracetam Accord je indicirano za dopolnilno zdravljenje:
Unit dose pack (perforated unit dose blister) containing 30x1, 60x1 and 100x1 tablets.
Enoodmerna pakiranja (v perforiranih enoodmernih pretisnih omotih), ki vsebujejo po 30x1, 60x1 in
Peak concentrations (Cmax) are typically 31 and 43 μg/ml following a single 1,000 mg dose and repeated 1,000 mg twice daily dose, respectively.
Po posamičnem odmerku 1.000 mg je največja koncentracija (Cmax) običajno 31 µg/ml, po ponavljajočih se odmerkih 1.000 mg dvakrat na dan pa 43 µg/ml.
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 filmsko obložene tablete Levetiracetam Accord 500 mg filmsko obložene tablete Levetiracetam Accord 750 mg filmsko obložene tablete Levetiracetam Accord 1.000 mg filmsko obložene tablete
Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
Odmerjanje pri dojenčkih (od 1 do 23 mesecev), otrocih (od 2 do 11 let) in mladostnikih (od 12 do 17 let), lažjih od 50 kg
The daily dose is administered in two equally divided doses.
Tableto lahko razdelimo na dva enaka odmerka.
• as an add-on to other antiepileptic medicines to treat: - partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age; - myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy - primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
miokloničnih napadov (kratki, nenadni trzaji mišice ali skupine mišic) pri odraslih in mladostnikih od 12. leta starosti z juvenilno mioklonično epilepsijo; primarno generaliziranih tonično-kloničnih napadov (veliki napadi, vključno z izgubo zavesti) pri odraslih in mladostnikih od 12. leta starosti z idiopatsko generalizirano epilepsijo (oblika epilepsije, za katero se domneva, da je genetskega izvora).
Muscular weakness, myalgia Rhabdomyolysis and blood creatine tissue disorders phosphokinase increased*
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišična oslabelost, mialgija rabdomioliza in zvišanje kreatin fosfokinaze v krvi*
MINIMUMPARTICULARS TO APPEAR ON BLISTERS OR STRIPS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Thrombocytopenia, leukopenia Pancytopenia, neutropenia, agranulocytosis
Bolezni krvi in limfatičnega sistema trombocitopenija levkopenija pancitopenija, nevtropenija, agranulocitoza
How to take Levetiracetam Accord
Kako jemati zdravilo Levetiracetam Accord
anger, confusion, panic attack,emotional instability/mood swings, agitation;
halucinacije, jeza, zmedenost, napadi panike, čustvena nestabilnost/nihanja v razpoloženju,
The in vitro data and in vivo interaction data on oral contraceptives, digoxin and warfarin indicate that no significant enzyme induction is expected in vivo.
In vitro podatki in in vivo podatki medsebojnega delovanja peroralnih kontraceptivov, digoksina in varfarina kažejo, da ni pričakovati pomembne in vivo encimske indukcije, zato je malo možnosti za interakcije med zdravilom Levetiracetam in drugimi snovmi oz. obratno.
• 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.
• parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti, z epilepsijo
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
Dopolnilno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti, z epilepsijo
In this study, levetiracetam, dose was 3000 mg /day given in 2 divided doses.
V tej študiji je bil odmerek levetiracetama 3.000 mg na dan, razdeljen na dva odmerka.
Single pack containing 10, 20, 30, 50, 60, 100, 200 tablets.
Eno pakiranje vsebuje po 10, 20, 30, 50, 60, 100 in 200 tablet.
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.
V tej študiji so bolnikom glede na njihovo starost predpisali shemo titriranja dnevnega odmerka peroralne raztopine po 20 mg/kg, 25 mg/kg, 40 mg/kg ali 50 mg/kg.
10 to 20 mg /kg (0.10 to
10 do 20 mg/kg (0,10 do
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.
Pri nadaljnjem dolgotrajnem zdravljenju je bilo 8,6 % bolnikov brez napadov najmanj 6 mesecev in 7,8 % bolnikov najmanj 1 leto.
Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Dopolnilno zdravljenje primarno generaliziranih tonično-kloničnih napadov pri odraslih in mladostnikih od 12. leta starosti, z idiopatsko generalizirano epilepsijo
Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination,anger, confusional state, panic attack, affect lability/mood swings, agitation
Psihiatrične motnje depresija, sovražnost/ agresivnost, anksioznost, nespečnost, živčnost/razdražljivost poskus samomora, razmišljanje o samomoru, psihotične motnje, nenormalno vedenje, halucinacije, jeza, stanje zmedenosti, napadi panike, čustvena labilnost/nihanja v razpoloženju, agitacija samomor,
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).
Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bil < 200 mg/kg/dan za samice in 200 mg/kg/dan za plodove (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg/m2).
(5) Following dialysis, a 5 to 10 mg /kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
(5) Po dializi je priporočljiv dodatni odmerek od 5 do 10 mg/kg (0,05 do 0,10 ml/kg).
(4) Following dialysis, a 3.5 to 7 mg /kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
(4) Po dializi je priporočljiv dodatni odmerek od 3,5 do 7 mg/kg (0,035 do 0,07 ml/kg).
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).
Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL) je bil ≥ 1.800 mg/kg/dan tako F0 samice kot za preživetje, rast in razvoj F1 mladičev do prenehanja dojenja (6-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2).
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.
Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bil pri brejih podganah 3.600 mg/kg/dan (12-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2) in pri plodovih 1.200 mg/kg/dan.
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).
V študijah pri novoskotenih živalih in mladičih živali so dokazali, da pri podganah in psih pri odmerkih do 1.800 mg/kg/dan (6-kratna do 17-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2) ni bilo neželenih učinkov na standardne parametre razvoja in dozorevanja.
250 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc
250 mg: polivinilalkohol, titanov dioksid (E171), makrogol, smukec
• in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
• miokloničnih napadov pri odraslih in mladostnikih od 12. leta starosti, z juvenilno mioklonično epilepsijo
• in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
• primarno generaliziranih tonično-kloničnih napadov pri odraslih in mladostnikih, od 12. leta starosti z idiopatsko generalizirano epilepsijo
If you get any side effects talk to your doctor or pharmacist.
− Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
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) dvakrat na dan
Polyvinyl alcohol Titanium dioxide (E171) Macrogol
polivinilalkohol titanov dioksid (E171)
Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Dopolnilno zdravljenje miokloničnih napadov pri odraslih in mladostnikih od 12. leta starosti, z juvenilno mioklonično epilepsijo
Completed suicide,personality disorder, thinking abnormal, delirium
osebnostne motnje, motnje mišljenja, delirij
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serije Accord Healthcare Ltd.
Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea
Bolezni prebavil bolečina v trebuhu, driska, dispepsija, bruhanje, slabost
Iron oxide yellow (E172)
500 mg železov oksid, rumena (E172)
For 1000mg:
Za 1.000 mg:
Children and adolescents - Levetiracetam Accord is not indicated in children and adolescents below 16 years on its own
• Zdravilo Levetiracetam Accord pri otrocih in mladostnikih, mlajših od 16 let, ni indicirano za samostojno zdravljenje (monoterapija).
Film-coated tablet The tablet can be divided into equal halves
Po peroralnem dajanju se lahko okusi grenak okus levetiracetama.Dnevni odmerek se daje razdeljen v dva enaka odmerka.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 10, 20, 30, 50, 60, 100, 200 tablets
PODATKI NA ZUNANJI OVOJNINI Škatla z 10, 20, 30, 50, 60, 100 in 200 tabletami
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) dvakrat na dan blaga ledvična okvara
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.
Zdravnik vam bo glede na starost, telesno maso in odmerek predpisal najprimernejšo farmacevtsko obliko zdravila Levetiracetam Accord.
(3) A 15 mg /kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
(3) Prvi dan zdravljenja z levetiracetamom je priporočljiv začetni odmerek 15 mg/kg (0,15 ml/kg).
Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73m2.
Če je očistek kreatinina < 60 ml/min/1,73 m2, je priporočljivo zmanjšati dnevni vzdrževalni odmerek za 50 %.
Levetiracetam Accord film-coated tablets 250 mg, 500 mg, 750 mg and 1000 mg are packed in PVC-Alu blister pack.
Levetiracetam Accord filmsko obložene tablete 250 mg, 500 mg, 750 mg in 1.000 mg so pakirane v
INFORMATION IN BRAILLE Levetiracetam Accord 1000 mg
Levetiracetam Accord 1.000 mg
750 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), sunset yellow FCF(E110)
polivinilalkohol, titanov dioksid (E171), makrogol, smukec, rumeni železov oksid (E172) 750 mg: polivinilalkohol, titanov dioksid (E171), makrogol, smukec, rdeč železov oksid (E172), oranžna FCF
Levetiracetam Accord 750 mg film-coated tablets Each film-coated tablet contains 750 mg levetiracetam
Levetiracetam Accord 750 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 750 mg levetiracetama.
Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
preobčutljivost (vključno z angioedemom in anafilakso)
(2) A 10.5 mg /kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
(2) Prvi dan zdravljenja z levetiracetamom je priporočljiv začetni odmerek 10,5 mg/kg (0,105 ml/kg).
Levetiracetam Accord 500 mg film-coated tablets Each film-coated tablet contains 500 mg levetiracetam
Levetiracetam Accord 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg levetiracetama.
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 filmsko obložene tablete Rožnate, podolgovate, bikonveksne tablete, z vtisnjeno oznako ‘L 66' in zarezo na eni strani ter brez oznak na drugi strani.
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.
Pretisni omoti so pakirani v škatlice po 10, 20, 30, 50, 60, 100 in 200 tablet.
In several cases of alopecia, recovery was observed when levetiracetam was discontinued.Bone marrow suppression was identified in some of the cases of pancytopenia.
V nekaterih primerih alopecije so po prekinitvi zdravljenja z levetiracetamom opazili izboljšanje.
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 filmsko obložene tablete Rumene, podolgovate, bikonveksne tablete, z vtisnjeno oznako ‘L 65' in zarezo na eni strani ter brez oznak na drugi strani.
Then CLcr is adjusted for body surface area (BSA) as follows:
72 x koncentracija kreatinina v serumu (mg/dl) CLcr je prilagojen na telesno površino (BSA -»body surface area«) na sledeč način: CLcr (ml/min)
Levetiracetam Accord 750 mg film-coated tablets Levetiracetam
Levetiracetam Accord 750 mg filmsko obložene tablete levetiracetam
Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents including levetiracetam.
Pri bolnikih, ki so se zdravili z antiepileptiki (vključno z levetiracetamom), so poročali o samomoru, poskusu samomora, samomorilnem razmišljanju in vedenju.
- 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.
• če ste pri otroku opazili počasnejšo rast ali nepričakovan razvoj v puberteti, se posvetujte z zdravnikom.
0.20 ml/kg) once daily (3) (5) (1) 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.
(1) Pri odmerkih, manjših od 250 mg, pri odmerkih, ki niso večkratniki 250 mg in priporočenega odmerjanja zato ni mogoče doseči z več tabletami, in pri bolnikih, ki ne morejo požirati tablet, je treba uporabiti levetiracetam v obliki peroralne raztopine.
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)
Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia,disturbance in attention
glavobol konvulzije, motnje ravnotežja, omotica, letargija, tremor amnezija, oslabljen spomin, poslabšana koordinacija/ataksija, parestezija, motnje pozornosti horeoatetoza, diskinezija, hiperkinezija, motnje hoje, encefalopatija
Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Levetiracetam overdoses.
Pri prevelikem odmerjanju zdravila Levetiracetam Accord so opažali somnolenco, agitiranost, agresivnost, zmanjšano stopnjo zavesti, depresijo dihanja in komo.
PVC-Alu blister
makrogol smukec
Levetiracetam Accord 1000 mg film-coated tablets Each film-coated tablet contains 1000 mg levetiracetam
Levetiracetam Accord 1.000 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 1.000 mg levetiracetama.
This medicine has been prescribed for you only.
− Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
What Levetiracetam Accord contains:
Zdravilo Levetiracetam Accord se uporablja:
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.
Za dojenčke in otroke, mlajše od 6 let, za otroke in mladostnike (od 6 do 17 let), lažjih od 50 kg in kadar s tabletami ne moremo zagotoviti natančnega odmerjanja je zdravilo Levetiracetam Accord 100 mg/ml peroralna raztopina primernejša farmacevtska oblika.
1000 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc
polivinilalkohol, titanov dioksid (E171), makrogol, smukec
Levetiracetam oral solution is the preferred formulation for use in this population.
Pri tej populaciji je najprimernejša farmacevtska oblika za uporabo zdravila levetiracetam peroralna raztopina.
Yellow coloured, oval, biconvex, film coated tablet, debossed ‘L 65' and break line on one side and plain on the other side.
Rumene, podolgovate, bikonveksne, filmsko obložene tablete z vtisnjeno oznako ‘L 65' in zarezo na eni strani ter brez oznak na drugi strani.
Nervous system disorders
Bolezni živčevja somnolenca,
Blood and lymphatic system disorders
Aluminijast/PVC pretisni omot
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 1.000 mg filmsko obložene tablete Bele ali umazano bele, podolgovate, bikonveksne tablete, z vtisnjeno oznako ‘L 67' in zarezo na eni strani ter brez oznak na drugi strani.
NAME OF THE MEDICINAL PRODUCT Levetiracetam Accord 500 mg film-coated tablets Levetiracetam
Levetiracetam Accord 500 mg filmsko obložene tablete levetiracetam
Levetiracetam Accord 250 mg film-coated tablets Levetiracetam
Levetiracetam Accord 250 mg filmsko obložene tablete levetiracetam
Pink coloured, oval, biconvex, film coated tablet, debossed ‘L 66' and break line on one side and plain on the other side.
Rožnate, podolgovate, bikonveksne, filmsko obložene tablete z vtisnjeno oznako ‘L 66' in zarezo na eni strani ter brez oznak na drugi strani.
Mild
MedDRA
7 to 14 mg /kg (0.07 to 0.14 ml/kg)once daily (2)
0,14 ml/kg) enkrat na dan (2) (4)
7 to 21 mg /kg (0.07 to 0.21 ml/kg) twice daily
7 do 21 mg/kg (0,07 do
STATEMENT OF ACTIVE SUBSTANCE (S) Each film-coated tablet contains 500 mg levetiracetam.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 500 mg levetiracetama.
Levetiracetam Accord 1000 mg film-coated tablet Levetiracetam
Levetiracetam Accord 1.000 mg filmsko obložene tablete 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 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/035-037 (30/60/100 tablet v enoodmernih pretisnih omotih)
Levetiracetam Accord 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam
KAKOVOSTNA IN KOLIČINSKA SESTAVA Levetiracetam Accord 250 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 250 mg levetiracetama.
How to store Levetiracetam Accord
Shranjevanje zdravila Levetiracetam Accord
White to off white, oval, biconvex, film coated tablet, debossed ‘L 67' and break line on one side and plain on the other side.
Bele ali umazano bele, podolgovate, bikonveksnefilmsko obložene tablete z vtisnjeno oznako ‘L 67' in zarezo na eni strani ter brez oznak na drugi strani.
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 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/029-031(30/60/100 tablet v enoodmernih pretisnih omotih)
5 to 15 mg /kg (0.05 to 0.15 ml/kg) twice daily
5 do 15 mg/kg (0,05 do
White to off white, oval, biconvex, film coated tablet, debossed ‘L 64' and break line on one side and plain on the other side.
Bele ali pastel bele barve, podolgovate, bikonveksne, filmsko obložene tablete, z vtisnjeno oznako ‘L 64' in zarezo na eni strani ter brez oznak na drugi strani.
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 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/032-034 (30/60/100 tablet v enoodmernih pretisnih omotih)
Each film-coated tablet contains 250 mg levetiracetam.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 250 mg levetiracetama.
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 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/038-040 (30/60/100 tablet v enoodmernih pretisnih omotih)
7 to 14 mg /kg (0.07 to 0.14 ml/kg) twice daily
7 do 14 mg/kg (0,07 do
MARKETING AUTHORISATION NUMBER(S) 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)
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/712/015-021 (10/20/30/50/60/100/200 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/035-037 (30/60/100 tablet v enoodmernih pretisnih omotih)
PVC/Alu blister pack:
Zdravilo je na voljo v pretisnih omotih iz PVC-ja/aluminija: