natgillin/translations-raw huggingface dataset:
The possible side effects of an overdose of levetiracetam are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Pri prevelikem odmerjanju levetiracetama so opažali somnolenco, agitiranost, agresivnost, zmanjšano stopnjo zavesti, depresijo dihanja in komo.
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 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet 120 filmsko obloženih tablet 200 filmsko obloženih tablet 60 x 1 filmsko obloženih tablet
Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function
Prilagoditev odmerjanja pri odraslih in mladostnikih s telesno maso, večjo kot 50 kg, z okvarjenim delovanjem ledvic:
Take the number of tablets following your doctor´s instructions.
Vzemite toliko tablet, kot vam je predpisal zdravnik.
Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
Reykjavikurvegur 76-78 220 Hafnarfjordur Islandija
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Islandija
Nasopharyngitis
• nazofaringitis
- This medicine has been prescribed for you only.
− Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
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 1000 mg odmerku je največja koncentracija (Cmax) ponavadi 31 µg/ml, po ponavljajočih odmerkih 1000 mg dvakrat na dan pa 43 µg/ml.
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.
Z nadaljevanjem dolgotrajnega zdravljenja je bilo 28,6 % bolnikov brez miokloničnih napadov vsaj 6 mesecev, 21,0 % pa jih je bilo brez miokloničnih napadov vsaj 1 leto.
C.
Z
How to take Levetiracetam Actavis
Kako jemati zdravilo Levetiracetam Actavis
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 Actavis in drugimi snovmi oz. obratno.
30 film-coated tablets 100 film-coated tablets 200 film-coated tablets
30 filmsko obloženih tablet 100 filmsko obloženih tablet 200 filmsko obloženih tablet
Steady-state is achieved after two days of a twice daily administration schedule.
Ob uporabi dvakrat na dan dosežemo stanje dinamičnega ravnovesja v dveh dneh.
Following single oral dose administration (20 mg/kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
Otroci (od 4 do 12 let) Po uporabi posamičnega peroralnega odmerka (20 mg/kg) pri otrocih z epilepsijo (od 6 do 12 let) je bil razpolovni čas levetiracetama 6,0 ur.
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.
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.
Zdravilo Levetiracetam Actavis je indicirano za samostojno zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri odraslih in mladostnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo.
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 levetiracetama.
Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland
Reykjavikurvegur 76-78, 220 Hafnarfjordur, Islandija
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.
Pri nadaljnjem dolgotrajnem zdravljenju je bilo 8,6 % bolnikov brez napadov najmanj 6 mesecev in 7,8 % bolnikov najmanj 1 leto.
In this study, levetiracetam, dose was 3,000 mg/day given in 2 divided doses.
V tej študiji je bil odmerek levetiracetama 3000 mg na dan, razdeljen na dva odmerka.
500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily
500 do 1500 mg dvakrat na dan 500 do 1000 mg dvakrat na dan 250 do 750 mg dvakrat na dan huda ledvična okvara končna ledvična odpoved bolniki na dializi (1)
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 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet 120 filmsko obloženih tablet 200 filmsko obloženih tablet
Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Samostojno zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri bolnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo
The cumulative urinary excretion of levetiracetam and its primary metabolite accounted for 66 % and 24 % of the dose, respectively during the first 48 hours.
V prvih 48 urah se s kumulativnim izločanjem z urinom izloči 66 % odmerka levetiracetama ter 24 %
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišična oslabelost,
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).
V študijah pri novorojenčkih in mladičih živali so dokazali, da pri podganah in psih, pri odmerkih do 1800 mg/kg/dan (6-kratna do 17-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2) ni bilo neželenih učinkov na običajna obdobja razvoja in dozorevanja.
In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection (see section 4.2).
Pri bolnikih z okvarjenim delovanjem jeter je pred izbiro odmerka priporočljivo oceniti delovanje ledvic
Levetiracetam Actavis 750 mg tablets contain Sunset Yellow (E110)
Zdravilo Levetiracetam Actavis 750 mg tablete vsebuje barvilo sončno rumeno FCF (E110)
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
Dopolnilno zdravljenje za dojenčke, stare od 6 do 23 mesecev, otroke (od 2 do 11 let) in mladostnike
Each film-coated tablet contains 0.156 mg sunset yellow E110.
Pomožne snovi z znanim učinkom: Ena filmsko obložena tableta vsebuje 0,156 mg barvila sončno rumeno FCF (E110).
CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Višina (cm) x ks CLcr (ml/min/1,73 m2) =----------------------------------------------------------koncentracija kreatinina v serumu (mg/dl)
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).
široko razširjen izpuščaj z mehurčki in luščenjem kože, še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom) in hujša oblika, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza).
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.
nadaljevanjem dolgotrajnega zdravljenja je bilo 11,4 % bolnikov brez napada vsaj 6 mesecev, 7,2 % pa jih je bilo brez napada vsaj 1 leto.
Aluminium/PVC blister packs.
Pretisni omoti Al/PVC.
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.
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) enkrat na dan (3) (5)
A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate.
do 17 let) je potrdila, da dopolnilna terapija s peroralno vzetim levetiracetamom ni vplivala na koncentracije v serumu v stanju dinamičnega ravnovesja pri sočasnem dajanju karbamazepina in valproata.
Should your doctor decide to stop your Levetiracetam Actavis treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Actavis.
Actavis, vam bo dal napotke o postopni ukinitvi zdravila Levetiracetam Actavis.
Adverse reactions reported in clinical studies (adults, adolescents, children and infants >1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency.
starejši od 1 meseca) in v postmarketinškem obdobju, so navedeni v spodnji tabeli po organskih sistemih in pogostnosti.
One tablet of Levetiracetam Actavis 1,000 mg contains 1,000 mg of levetiracetam.
Ena tableta zdravila Levetiracetam Actavis 1000 mg vsebuje 1000 mg levetiracetama.
Levetiracetam Actavis 1,000 mg film-coated tablets Each film-coated tablet contains 1,000 mg levetiracetam.
Levetiracetam Actavis 1.000 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 1.000 mg levetiracetama.
The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food.
Način uporabe Filmsko obložene tablete se zaužijejo peroralno z dovolj tekočine.
Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m2.
Če je očistek kreatinina < 60 ml/min/1,73 m2, je priporočljivo zmanjšati dnevni vzdrževalni odmerek za
Excretion via faeces accounted for only 0.3 % of the dose.
Z blatom se izloči le 0,3 % odmerka.
One tablet of Levetiracetam Actavis 500 mg contains 500 mg of levetiracetam.
Ena tableta zdravila Levetiracetam Actavis 500 mg vsebuje 500 mg levetiracetama.
One tablet of Levetiracetam Actavis 250 mg contains 250 mg of levetiracetam.
Ena tableta zdravila Levetiracetam Actavis 250 mg vsebuje 250 mg levetiracetama.
250 to 500 mg twice daily
250 do 500 mg dvakrat na dan 500 do 1000 mg enkrat na dan(2)
Contact your doctor if you took more tablets than you should.
Če ste vzeli več tablet kot bi morali, se posvetujte s svojim zdravnikom.
• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Zdravilo Levetiracetam Actavis se uporablja: • za samostojno zdravljenje pri odraslih in mladostnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo, za zdravljenje določene oblike epilepsije.
Peak plasma concentration was observed 0.5 to 1.0 hour after dosing.
Največja plazemska koncentracija je bila dosežena med 0,5
Nervous system disorders
MedDRA organski sistem
No dose adjustment is needed in patients with mild to moderate hepatic impairment.
Bolniki z jetrno okvaro Pri bolnikih z blago do zmerno jetrno okvaro odmerka ni potrebno prilagajati.
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.
• 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).
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 (vrsta epilepsije, ki je genetskega izvora)
One tablet of Levetiracetam Actavis 750 mg contains 750 mg of levetiracetam.
Ena tableta zdravila Levetiracetam Actavis 750 mg vsebuje 750 mg levetiracetama.
The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighing 50 kg or more, using the following formula:
CLcr v ml/min je pri odraslih in mladostnikih, s telesno maso 50 kg in več, mogoče oceniti iz koncentracije kreatinina v serumu (mg/dl) po formuli: [140 - starost (leta)] x masa (kg) CLcr (ml/min) = ------------------------------------------------------------- (x 0,85 za ženske) 72 x koncentracija kreatinina v serumu (mg/dl) CLcr je prilagojen na telesno površino (BSA-»body surface area«) na sledeč način:
- If you get any side effects talk to your doctor or pharmacist.
− Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s 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
An oral solution is the formulation to use in infants.
Peroralna raztopina je farmacevtska oblika, ki je prilagojena za uporabo pri dojenčkih.
Each film-coated tablet contains 1,000 mg levetiracetam.
Ena filmsko obložena tableta vsebuje 1000 mg levetiracetama.
A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour.
Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih, s placebom nadzorovanih kliničnih preskušanj antiepileptikov.
The risk of anorexia is higher when levetiracetam is coadministered with topiramate.
Opis izbranih neželenih učinkov Tveganje za pojav anoreksije je večje pri sočasni uporabi levetiracetama in topiramata.
(2) Following dialysis, a 250 to 500 mg supplemental dose is recommended.
(1) Prvi dan zdravljenja z levetiracetamom je priporočljiv začetni odmerek 750 mg. (2) Po dializi je priporočljiv dodatni odmerek od 250 do 500 mg.
(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).
Levetiracetam Actavis 750 mg film-coated tablets Each film-coated tablet contains 750 mg levetiracetam.
Levetiracetam Actavis 750 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 750 mg levetiracetama.
Each tablet contains 1,000 mg levetiracetam.
Ena tableta vsebuje 1000 mg levetiracetama.
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) dvakrat na dan
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.
Levetiracetam Actavis 750 mg filmsko obložene tablete so: ovalne, oranžne, velike 19,0 x 9,3 mm z oznako “L” na eni strani in “750” na drugi strani.
CLcr (ml/min/1.73 m
(ml/min/1,73m2)
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) dvakrat na dan
Drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity (including angioedema and anaphylaxis)
preobčutljivost (vključno z angioedemom in anafilakso)
250 mg tablet: Indigo carmine (E132).
250 mg tableta: indigotin (E132) 500 mg tableta: rumeni železov oksid (E172), indigotin (E132)
Levetiracetam Actavis 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam.
Levetiracetam Actavis 250 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 250 mg levetiracetama.
• partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age;
• napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih,
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 filmsko obložene tablete Ovalne, oranžne, velike 19.0 x 9.3 mm z oznako “L” na eni strani in “750” na drugi strani.
Monotherapy for adults and adolescents from 16 years of age The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks.
Priporočeni začetni odmerek je 250 mg dvakrat na dan, ki ga po dveh tednih povečamo na začetni terapevtski odmerek 500 mg dvakrat na dan. Odmerek se lahko poveča za 250 mg dvakrat na dan vsaka dva tedna glede na klinični odziv.
Levetiracetam Actavis 500 mg film-coated tablets Each film-coated tablet contains 500 mg levetiracetam.
Levetiracetam Actavis 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg levetiracetama.
This is related to the decrease in renal function in this population (see section 4.2).
11 ur) (glejte poglavje 4.2).
Levetiracetam Actavis 250 mg film-coated tablets 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 filmsko obložene tablete Ovalne, svetlo modre, velike 13.6 x 6.4 mm z oznako “L” na eni strani in “250” na drugi 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 filmsko obložene tablete so: ovalne, svetlo modre, velike 13,6 x 6,4 mm z oznako “L” na eni strani in “250” na drugi strani.
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 1.000 mg filmsko obložene tablete Ovalne, bele, velike 19.0 x 10.0 mm z oznako “L” na eni strani in “1000” na drugi strani.
Each film-coated tablet contains 750 mg levetiracetam.
Ena filmsko obložena tableta vsebuje 750 mg levetiracetama.
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 filmsko obložene tablete Ovalne, rumene, velike 17.1 x 8.1 mm z oznako “L” na eni strani in “500” na drugi strani.
(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 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.
Levetiracetam Actavis 500 mg filmsko obložene tablete so: ovalne, rumene, velike 17,1 x 8,1 mm z oznako “L” na eni strani in “500” na drugi strani.
Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation
nespečnost, živčnost/razdražljivost poskus samomora, razmišljanje o samomoru, psihotične motnje, nenormalno vedenje, halucinacije, jeza, stanje zmedenosti,
Each tablet contains 500 mg levetiracetam.
Ena tableta vsebuje 500 mg levetiracetama.
basis) and 1,200 mg/kg/day for fetuses.
1800 mg/kg/dan.
Povidone
Odvajala
Levetiracetam Actavis 1,000 mg film-coated tablets
Levetiracetam Actavis 1.000 mg filmsko obložene tablete
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.
Levetiracetam Actavis 1000 mg filmsko obložene tablete so: ovalne, bele, velike 19,0 x 10,0 mm z oznako “L” na eni strani in “1000”na drugi strani.
Perforated unit dose blisters: EU/1/11/713/042 60 x 1 tablets
Perforiranem pretisnem omotu za enkratni odmerek: EU/1/11/713/042 60 x 1 tablet
Each tablet contains 250 mg levetiracetam.
Ena tableta vsebuje 250 mg levetiracetama.
Each film-coated tablet contains 500 mg levetiracetam.
Ena filmsko obložena tableta vsebuje 500 mg levetiracetama.
Perforated unit dose blisters: EU/1/11/713/043 60 x 1 tablets
Perforiranem pretisnem omotu za enkratni odmerek: EU/1/11/713/043 60 x 1 tablet
Contact your doctor if you have missed one or more doses.
Če ste pozabili vzeti zdravilo Levetiracetam Actavis Če pozabite vzeti enega ali več odmerkov, se posvetujte s svojim zdravnikom.
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,
Each film-coated tablet contains 250 mg levetiracetam.
Ena filmsko obložena tableta vsebuje 250 mg levetiracetama.
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 tablet EU/1/11/713/019 100 tablet EU/1/11/713/020 200 tablet
Perforated unit dose blisters: EU/1/11/713/041 60 x 1 tablets
Perforiranem pretisnem omotu za enkratni odmerek: EU/1/11/713/041 60 x 1 tablet
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 1,000 mg film-coated tablets in tablet containers
PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 1000 mg filmsko obložene tablete
Talk to your doctor before taking Levetiracetam Actavis
Pred začetkom jemanja zdravila Levetiracetam Actavis se posvetujte s svojim zdravnikom.
INFORMATION IN BRAILLE 17.
NAVODILA ZA UPORABO 16.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 750 mg film-coated tablets in tablet containers
PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 750 mg filmsko obložene tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 250 mg film-coated tablets in tablet containers
PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 250 mg filmsko obložene tablete
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 tablet EU/1/11/713/029 100 tablet EU/1/11/713/030 200 tablet
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 500 mg film-coated tablets in tablet containers
PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 500 mg filmsko obložene tablete
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 tablet EU/1/11/713/009 100 tablet EU/1/11/713/010 200 tablet
How to store Levetiracetam Actavis
Shranjevanje zdravila Levetiracetam Actavis
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 tablet EU/1/11/713/039 100 tablet EU/1/11/713/040 200 tablet
Levetiracetam Actavis 500 mg film-coated tablets
Levetiracetam Actavis 500 mg filmsko obložene tablete
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) enkrat na dan (2) (4)
Each tablet contains 750 mg levetiracetam.
Ena tabletavsebuje 750 mg levetiracetama.
- Keep this leaflet.
− Navodilo shranite.
Titanium dioxide (E171) Indigo carmine (E132) Sunset yellow (E110) Iron oxide red (E172)
sončno rumeno (E110) rdeči železov oksid (E172)
Levetiracetam Actavis 750 mg film-coated tablets
Levetiracetam Actavis 750 mg filmsko obložene tablete
72.2 % of the levetiracetam treated patients and 45.2 % of the patients on placebo had a 50 % or greater decrease in the frequency of PGTC seizures per week.
Pri 72,2 % bolnikov, ki so se zdravili z levetiracetamom, in 45,2 % bolnikov, ki so prejemali placebo,