natgillin/translations-raw huggingface dataset:
Adverse effects not observed in clinical studies but seen in the rat and to a lesser extent in the mouse at exposure levels similar to human exposure levels and with possible relevance for clinical use were liver changes, indicating an adaptive response such as increased weight and centrilobular hypertrophy, fatty infiltration and increased liver enzymes in plasma.
Neželeni učinki, ki jih niso opažali v kliničnih študijah, opazili pa so jih pri podganah in v manjši meri pri miših ob izpostavljenosti, podobni izpostavljenosti pri človeku (in torej potencialno pomembni za klinično uporabo), so jetrne spremembe.
Levetiracetam Actavis Group contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, maltitol, propylene glycol and sodium.
Zdravilo Levetiracetam Actavis Group vsebuje metilparahidroksibenzoat, propilparahidroksibenzoat, maltitol, propilenglikol in natrij
General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg bodyweight of the child. (see table below for dose examples).
Običajni odmerek: zdravilo Levetiracetam Actavis Group se jemlje dvakrat na dan v dveh enakih odmerkih, pri čemer vsak posamezni odmerek znaša od 0,1 ml (10 mg) do 0,3 ml (30 mg) na kg telesne mase otroka (za primere odmerkov glejte spodnjo preglednico).
Depending upon the clinical response and tolerability, the dose can be increased up to 21 mg/kg twice daily.
Glede na klinični odziv in prenašanje je mogoče dnevni odmerek povečati do 21 mg/kg dvakrat na dan.
Dose in infants (1 month to less than 6 months):
Odmerek za dojenčke (od 1 meseca do manj kot 6 mesecev):
How to store Levetiracetam Actavis Group Contents of the pack and other information
Shranjevanje zdravila Levetiracetam Actavis Group Vsebina pakiranja in dodatne informacije
Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily.
Glede na klinični odziv in prenašanje je mogoče dnevni odmerek povečati do 30 mg/kg dvakrat na dan.
General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg bodyweight of the infant.
Splošen odmerek: zdravilo Levetiracetam Actavis Group se jemlje dvakrat na dan v dveh enakih odmerkih, pri čemer vsak posamezni odmerek znaša od 0,07 ml (7 mg) do 0,21 ml (21 mg) na kg telesne mase dojenčka (za primere odmerkov glejte spodnjo preglednico).
Dose recommendations for infants aged from 1 month to less than 6 months:
Priporočila za odmerjanje pri dojenčkih v starosti od 1 meseca do manj kot 6 mesecev:
• somnolence (sleepiness), headache.
• nazofaringitis • somnolenca (zaspanost), glavobol
49 mg (0.5 ml) twice daily 147 mg (1.5 ml) twice daily
49 mg (0,5 ml) dvakrat na dan 147 mg (1,5 ml) dvakrat na dan
Other medicines and Levetiracetam Actavis Group
Druga zdravila in zdravilo Levetiracetam Actavis Group
• vertigo (sensation of rotation);
• vrtoglavica (občutek vrtenja)
Wash the syringe with water after use and close the bottle with the plastic screw cap (Figure 10).
Po uporabi brizgo izperite z vodo in jo zaprite s plastičnim navojnim pokrovčkom (slika 10).
Dosing adjustment for infants, children and adolescent patients weighing less than 50 kg with impaired renal function:
Prilagoditev odmerka pri dojenčkih, otrocih in mladostnikih s telesno maso manj kot 50 kg in okvarjenim delovanjem ledvic Skupina
For children aged 1 month to less than 6 months.
Za otroke, stare od 1 meseca do manj kot 6 mesecev.
• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger,
• poskus samomora in razmišljanje o samomoru, duševne motnje, nenormalno vedenje,
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; po dveh tednih ga je treba povečati na uvodni terapevtski odmerek 500 mg dvakrat na dan. Odmerek je mogoče še naprej povečevati po 250 mg dvakrat na dan vsaka dva tedna, odvisno od kliničnega odziva.
Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.
Pri bolnikih, ki se sočasno zdravijo z obema učinkovinama, je potrebno skrbno spremljanje koncentracije metotreksata in levetiracetama v krvi.
Results related to behavioral 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).
standardizirano in sistematično merjenega z validiranim instrumentom (CBCL - Achenbach Child Behaviour Checklist).
Levetiracetam is rapidly absorbed after oral administration.
Levetiracetam se po peroralni uporabi hitro absorbira.
Steady-state is achieved after two days of a twice daily administration schedule.
Ob uporabi dvakrat na dan je stanje dinamičnega ravnovesja doseženo v dveh dneh.
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 epileptičnih napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti z epilepsijo:
Wash the syringe with water after use and close the bottle with the plastic screw cap (Figure 4).
Po uporabi brizgo izperite z vodo in jo zaprite s plastičnim navojnim pokrovčkom (slika 4).
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 kumulativno z izločanjem levetiracetama v urinu izloči 66 % odmerka in njegovega primarnega presnovka 24 % odmerka.
35 mg (0.35 ml) twice daily 105 mg (1.05 ml) twice daily
35 mg (0,35 ml) dvakrat na dan 105 mg (1,05 ml) dvakrat na dan
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, napad panike, čustvena labilnost/nihanja v razpoloženju, agitacija samomor, osebnostne motnje, motnje mišljenja, delirij
Maltitol liquid (E965) Acesulfame potassium (E950) Grape flavour (contains propylene glycol) Purified water
kalijev acesulfamat (E950) aroma grozdja (vsebuje polipropilenglikol)
In a pooled analysis, the percentage of patients who achieved 50% or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7%, 31.6% and 41.3% for patients on 1,000, 2,000 or 3,000 mg levetiracetam respectively and of 12.6% for patients on placebo.
Kumulativna analiza je pokazala, da je bil odstotek bolnikov, ki so dosegli zmanjšanje tedenske pogostnosti napadov parcialnega izvora v primerjavi z izhodiščem za 50 % ali več, ob stabilnih odmerkih (12/14 tednov) med prejemniki 1.000 mg levetiracetama 27,7 %,
Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Monoterapija za zdravljenje epileptičnih napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri bolnikih od 16. leta starosti z novoodkrito epilepsijo.
The initial therapeutic dose is 10 mg/kg twice daily.
Začetni terapevtski odmerek je 10 mg/kg dvakrat na dan.
• in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
• za zdravljenje primarno generaliziranih tonično-kloničnih napadov pri odraslih in mladostnikih od 12. leta starosti, ki imajo idiopatsko generalizirano epilepsijo.
(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).
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva mišična oslabelost,
If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
Če je vaš otrok mlajši od 4 tednov, se pred dajanjem zdravila posvetujte z zdravnikom ali farmacevtom.
You should not stop your treatment without discussing this with your doctor.A risk of birth defects for your unborn child cannot be completely excluded.
Tveganje za defekte še nerojenega otroka ni mogoče popolnoma izključiti.
As with all antiepileptic medicines, sudden discontinuation of levetiracetam should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible because therapy with multiple antiepileptic medicines AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.
Kot pri vseh drugih antiepileptikih se je treba nenadni prekinitvi uporabe levetiracetama izogniti, saj lahko to povzroči izbruh napadov, ki imajo lahko resne posledice za žensko in nerojenega otroka.
• suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
• samomor, osebnostne motnje (vedenjske motnje), motnje mišljenja (počasno razmišljanje,
300 ml oral solution
300 ml peroralna raztopina
for patients unable to swallow tablets or for the administration of doses below 250 mg.
Poleg tega je treba peroralno raztopino uporabiti za uvodno zdravljenje otrok, lažjih od 25 kg, bolnikov, ki ne morejo pogoltniti tablet, in za dajanje odmerkov, manjših od 250 mg.
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.
Med nadaljevalnim dolgoročnim zdravljenjem je bilo brez tonično-kloničnih napadov vsaj 6 mesecev 47,4 % bolnikov, vsaj 1 leto pa 31,5 % bolnikov.
The initial therapeutic dose is 7 mg/kg twice daily.
Začetni terapevtski odmerek je 7 mg/kg dvakrat na dan.
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.
Med nadaljevanjem dolgotrajnega zdravljenja je bilo 8,6 % bolnikov brez napadov vsaj 6 mesecev, 7,8 % pa jih je bilo brez napadov vsaj 1 leto.
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.
(starih od 4 do 17 let) je potrdila, da dopolnilno zdravljenje s peroralnim levetiracetamom ni vplivalo na koncentracijo sočasno uporabljenega karbamazepina in valproata v serumu v stanju dinamičnega ravnovesja.
Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinylestradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
(etinilestradiola in levonorgestrela); endokrini parametri (luteinizirajoči hormon in progesteron) se niso spremenili.
(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).
Turn the bottle upside down with the syringe still in place (Figure 4).
Obrnite stekleničko na glavo; brizga naj medtem ostane nameščena (slika 4).
Rare disorders headache disorder, dizziness, lethargy, tremor impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention dyskinesia, hyperkinesia, gait disturbance, encephalopathy
letargija, tremor koordinacija/ataksija, parestezija, motnje pozornosti hiperkinezija, motnje hoje, encefalopatija
180 mg (1.8 ml) twice daily
180 mg (1,8 ml) dvakrat na dan
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.
Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.
Ustrezen odmerek izmerite z uporabo 10-mililitrske brizge, vključene v pakiranje za bolnike, stare
Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Bolezni kože in podkožja izpuščaj alopecija, ekcem, pruritus toksična epidermalna nekroliza, StevensJohnsonov sindrom, multiformni eritem
Quincke's oedema [swelling of the face, lips, tongue and throat]);
Quinckejev edem [otekanje obraza, ustnic, jezika in žrela]) • znižana koncentracija natrija v krvi
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 (4 do 12 let) Po uporabi enega peroralnega odmerka (20 mg/kg) pri otrocih z epilepsijo (starih od 6 do 12 let) je bil razpolovni čas levetiracetama 6,0 ur.
With continued long-term treatment, 11.4% of the patients were seizure-free for at least 6 months and 7.2% were seizure-free for at least 1 year.
Med nadaljevanjem dolgotrajnega zdravljenja je bilo 11,4 % bolnikov brez napadov vsaj 6 mesecev, 7,2 % pa jih je bilo brez napadov vsaj 1 leto.
Citric acid monohydrate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Ammonium glycyrrhizate
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev citrat citronska kislina monohidrat metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) amonijev glicirizat glicerin glicerol (E422)
Treatment with levetiracetam should be reviewed when a woman is planning to become pregnant.
Če ženska načrtuje nosečnost, je treba ponovno pretehtati zdravljenje z levetiracetamom.
Pancreatitis
Kreatinin
Specialist advice should be given to women who are of childbearing potential.
Ženskam v rodni dobi mora svetovati zdravnik specialist.
A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 and 1,800 mg/kg/day.
Na podganah je bila opravljena študija peri- in postnatalnega razvoja z odmerki levetiracetama 70, 350
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.
Pogostnost PGTC-napadov na teden se je zmanjšala za 50 % ali več pri 72,2 % prejemnikov levetiracetama in pri 45,2 % prejemnikov placeba.
• in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
• za zdravljenje miokloničnih napadov pri odraslih in mladostnikih od 12. leta starosti, ki imajo juvenilno mioklonično epilepsijo.
- A 300 ml bottle with a 3 ml oral syringe (delivering up to 300 mg levetiracetam) graduated every 0.1 ml (corresponding to 10 mg).
- 300-ml steklenica s 3-ml peroralno brizgo (ki vsebuje do 300 mg levetiracetama) z odmernimi oznakami na 0,1 ml (to ustreza 10 mg).
58.3% of the levetiracetam treated patients and 23.3% of the patients on placebo had at least a 50% reduction in myoclonic seizure days per week.
Vsaj 50 % zmanjšanje dni z miokloničnimi napadi na teden so ugotovili pri 58,3 % prejemnikov levetiracetama in pri 23,3 % prejemnikov placeba.
The active substance is called levetiracetam.
Zdravilna učinkovina je levetiracetam.
300 ml oral solution with a 10 ml oral syringe.
300 ml peroralne raztopine z 10-ml peroralno brizgo.
Immune system disorders
MedDRA organski sistem
The volume of distribution of levetiracetam is approximately 0.5 to 0.7 l/kg, a value close to the total body water volume.
Ne levetiracetam ne njegov primarni presnovek nista pomembno vezana na beljakovine v plazmi (< 10 Volumen porazdelitve levetiracetama je približno 0,5 do 0,7 l/kg; ta vrednost je blizu celotni količini vode v telesu.
- A 300 ml bottle with a 1 ml oral syringe (delivering up to 100 mg levetiracetam) graduated every 0.05 ml (corresponding to 5 mg).
- 300-ml steklenica z 1-ml peroralno brizgo (ki vsebuje do 100 mg levetiracetama) z odmernimi oznakami na 0,05 ml (to ustreza 5 mg).
How to take Levetiracetam Actavis Group
Kako jemati zdravilo Levetiracetam Actavis Group
confusion, panic attack, emotional instability/mood swings, agitation;
halucinacije, jeza, zmedenost, napad panike, čustvena nestabilnost/nihanja v razpoloženju, agitacija (motorični nemir)
The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.
Varnost in učinkovitost monoterapije z levetiracetamom pri otrocih in mladostnikih, mlajših od 16. let,
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.
Use the 10 ml syringe included in the package.
Uporabite 10-ml peroralno brizgo, priloženo v pakiranju.
Add-on therapy for infants from 1 month to less than 6 months
Dodatno zdravilo za dojenčke od 1 meseca do manj kot 6 mesecev starosti
Bone marrow suppression was identified in some of the cases of pancytopenia.
Supresija kostnega mozga je bila identificirana v nekaterih primerih pancitopenije.
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.
Med nadaljevalnim dolgoročnim zdravljenjem je bilo brez miokloničnih napadov vsaj 6 mesecev 28,6 % bolnikov, vsaj 1 leto pa 21,0 % bolnikov.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj
If you forget to take Levetiracetam Actavis Group
Če ste pozabili vzeti zdravilo Levetiracetam Actavis Group:
The possible side effects of an overdose of Levetiracetam Actavis Group are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
V primerih prevelikega odmerjanja levetiracetama so opažali zaspanost, agitiranost, agresivnost, deprimirano raven zavesti, depresijo dihanja in komo.
Levetiracetam elimination is correlated to creatinine clearance.
Očistek levetiracetama korelira z očistkom kreatinina.
Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m2.
< 60 ml/min/1,73 m2, je zato priporočljivo 50 % zmanjšanje dnevnega vzdrževalnega odmerka.
The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerin, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour (contains propylene glycol), purified water.
(E218), propilparahidroksibenzoat (E216), amonijev glicirizat, glicerin, glicerol (E422), tekoči maltitol (E965), kalijev acesulfamat (E950), sroma grozdja (vsebuje propilenglikol), prečiščena voda.
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.
Zdravnik bo glede na starost, telesno maso in odmerek predpisal najprimernejšo farmacevtsko obliko levetiracetama.
Safety results in paediatric patients in placebo-controlled clinical studies were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults.
Pri pediatričnih bolnikih so bili podatki o varnosti iz s placebom nadzorovanih študij skladni z varnostnim profilom levetiracetama pri odraslih.
Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
Bolezni imunskega sistema reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS),
The renal clearance of levetiracetam and ucb L057 is 0.6 and 4.2 ml/min/kg respectively indicating that levetiracetam is excreted by glomerular filtration with subsequent tubular reabsorption and that the primary metabolite is also excreted by active tubular secretion in addition to glomerular filtration.
To kaže, da se levetiracetam izloča z glomerularno filtracijo, ki ji sledi tubularna reabsorpcija, izločanje primarnega presnovka pa poleg glomerularne filtracije obsega še aktivno tubularno sekrecijo.
60 mg (0.6 ml) twice daily
60 mg (0,6 ml) dvakrat na dan
For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
Za dojenčke, stare od 1 meseca do manj kot 6 mesecev, ustrezen odmerek izmerite z uporabo
(2) Following dialysis, a 250 to 500 mg supplemental dose is recommended.
(1) Prvi dan zdravljenja z levetiracetamom je priporočljiv polnilni odmerek 750 mg. (2) Po dializi je priporočljiv dodatni odmerek od 250 do 500 mg.
Tabulated list of adverse reactions
(anafilaktične) reakcije
What Levetiracetam Actavis Group looks like and contents of the pack
Izgled zdravila Levetiracetam Actavis Group in vsebina pakiranja
Pancytopenia, neutropenia, agranulocytosis
driska, dispepsija, bruhanje, navzeja pankreatitis
250 to 750 mg twice daily
250 do 750 mg dvakrat na dan
If you stop taking Levetiracetam Actavis Group
Če ste prenehali jemati zdravilo Levetiracetam Actavis Group:
Excretion via faeces accounted for only 0.3% of the dose.
V blatu se izloči le 0,3 % odmerka.
Levetiracetam Actavis Group 100 mg/ml oral solution contains maltitol liquid.
Zdravilo Levetiracetam Actavis Group 100 mg/ml peroralna raztopina vsebuje tekoči maltitol.
Dose in children 6 months and older:
Odmerek pri dojenčkih, starejših od 6 mesecev:
500 mg twice daily
500 mg dvakrat na dan
Depression, hostility/ aggression, anxiety, insomnia, nervousness/irritability
Psihiatrične motnje depresija, sovražnost/ agresivnost, anksioznost,
300 ml oral solution with a 3 ml oral syringe and an adaptor.
300 ml peroralne raztopine s 3-ml peroralno brizgo in nastavkom
• cough;
• kašelj
Maximum dose: 21 mg/kg twice daily
Največji odmerek: 21 mg/kg dvakrat na dan
Levetiracetam Actavis Group oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
in propilparahidroksibenzoat (E216), ki lahko povzročita alergijske reakcije (lahko zapoznele).
0.85 ml twice daily
0,85 ml dvakrat na dan
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• bolečina v trebuhu, driska, dispepsija (slaba prebava), bruhanje, slabost
If you get any side effects talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness.
Neželeni učinki, o katerih so najpogosteje poročali, so nazofaringitis, somnolenca (zaspanost),
Infants 6 to 23 months, children and adolescents weighing less than 50 kg
Odmerjanje pri otrocih, starih 6 mesecev in več, lažjih od 50 kg
500 to 1,000 mg twice daily
500 do 1.000 mg dvakrat na dan
500 to 1,500 mg twice daily
500 do 1.500 mg dvakrat na dan
Moderate
Zmerno
Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses.
vznemirjenost, agresivnost, poslabšanje pozornosti, zavrtje dihanja in koma.
Three presentations are available: - A 300 ml bottle with a 10 ml oral syringe (delivering up to 1,000 mg levetiracetam) graduated every 0.25 ml (corresponding to 25 mg).
- 300-ml steklenica z 10-ml peroralno brizgo (ki vsebuje do 1.000 mg levetiracetama) z odmernimi oznakami na 0,25 ml (to ustreza 25 mg).