natgillin/translations-raw huggingface dataset:
For clinical trials, the frequency is defined as follows: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports.
(≥1/ 10); pogosti:
Data from post-marketing experience are insufficient to support an estimate of their incidence in the population to be treated.
(≥1/ 10, 000, < 1/ 1, 000); zelo redki:
- General disorders and administration site conditions
(< 1/ 10, 000), vključno s posameznimi primeri.
Very common: asthenia/ fatigue.
− Splošne težave in spremembe na mestu aplikacije Zelo pogosti: astenija/ utrujenost
Post-marketing experience: paraesthesia
− Bolezni živčevja Zelo pogosti: somnolenca Pogosti: amnezija, ataksija, konvulzije, omotica, glavobol, hiperkinezija, tremor, motnje ravnotežja, motnje pozornosti, oslabljen spomin Postmarketinške izkušnje: parestezija
Common: agitation, depression, emotional lability / mood swings, hostility/ aggression, insomnia, nervousness/ irritability, personality disorders, thinking abnormal Post-marketing experience: abnormal behaviour, anger, anxiety, confusion, hallucination, psychotic disorder, suicide, suicide attempt and suicidal ideation
− Psihiatrične motnje Pogosti: agitiranost, depresija, čustvena labilnost/ nihanja v razpoloženju, sovražnost/ agresivnost, nespečnost, živčnost/ razdražljivost, osebnostne motnje, motnje mišljenja Postmarketinške izkušnje: nenormalno vedenje, jeza, anksioznost, zmedenost, halucinacije, psihotične motnje, samomor, poskus samomora in razmišljanje o samomoru
Common: abdominal pain, diarrhoea, dyspepsia, nausea, vomiting Post-marketing experience: pancreatitis
− Bolezni prebavil Pogosti: bolečina v trebuhu, driska, dispepsija, navzea, bruhanje Postmarketinške izkušnje: pankreatitis
Post-marketing experience: hepatic failure, hepatitis, liver function test abnormal
− Bolezni jeter, žolčnika in žolčevodov Postmarketinške izkušnje: odpoved jeter, hepatitis, nenormalne vrednosti testov jetrnih funkcij
- Metabolism and nutrition disorders
− Presnovne in prehranske motnje Pogosti: anoreksija, povečanje telesne mase.
The risk of anorexia is higher when topiramate is coadministered with levetiracetam.
Tveganje za pojav anoreksije je večje pri sočasni uporabi topiramata in levetiracetama.
Common: diplopia, vision blurred
18 Postmarketinške izkušnje: zmanjšanje telesne mase
- Musculoskeletal and connective tissue disorders
− Ušesne bolezni, vključno z motnjami labirinta Pogosti: vrtoglavica
- Injury, poisoning and procedural complications
− Očesne bolezni Pogosti: diplopija, zamegljen vid
Common: accidental injury
− Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosti: mialgija
Common: rash, eczema, pruritus Post-marketing experience: alopecia: in several cases, recovery was observed when Keppra was discontinued.
− Bolezni kože in podkožja Pogosti: izpuščaj, ekcem, pruritus.
- Blood and lymphatic system disorders
Postmarketinške izkušnje: alopecija: v nekaterih primerih so po prekinitvi zdravljenja s Keppro opazili izboljšanje.
19 Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Keppra overdoses.
Pri prevelikem odmerjanju Keppre so opažali zaspanost, agitiranost, agresivnost, zmanjšano stopnjo zavesti, depresijo dihanja in komo.
The mechanism of action of levetiracetam still remains to be fully elucidated but appears to be different from the mechanisms of current antiepileptic medicinal products.
19 Mehanizem delovanja levetiracetama še vedno ni popolnoma pojasnjen, vendar kaže, da je drugačen od mehanizmov drugih protiepileptičnih zdravil.
20 In pediatric patients (4 to 16 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 198 patients and had a treatment duration of 14 weeks.
Pri otrocih (od 4 do 16 let) je bila učinkovitost levetiracetama dokazana v dvojno slepi, s placebom nadzorovani študiji, ki je vključevala 198 bolnikov in trajala 14 tednov.
44.6% of the levetiracetam treated patients and 19.6% of the patients on placebo had a 50% or greater reduction from baseline in the partial onset seizure frequency per week.
Pri 44, 6% bolnikov, ki so se zdravili z levetiracetamom, in 19, 6% bolnikov, ki so prejemali placebo, je bilo 50 ali več odstotno zmanjšanje pogostnosti napadov parcialnega izvora na teden.
The patients were randomized to carbamazepine CR 400 – 1200 mg/ day or levetiracetam 1000 – 3000 mg/ day, the duration of the treatment was up to 121 weeks depending on the response.
Bolniki so randomizirano prejemali 400- 1200 mg karbamazepina z nadzorovanim sproščanje (CR) na dan ali 1000- 3000 mg levetiracetama na dan, trajanje zdravljenja pa je bilo do 121 tednov oziroma odvisno od odziva.
More than half of the subjects remained seizure free for 12 months (56.6% and 58.5% of subjects on levetiracetam and on carbamazepine CR respectively).
20 12 mesecev ni imela napadov (56, 6% preiskovancev, ki so prejemali levetiracetam, in 58, 5% preiskovancev, ki so prejemali karbamazepin z nadzorovanim sproščanjem).
Levetiracetam efficacy was established in a 24-week double-blind, placebo-controlled study, which included adults, adolescents and a limited number of children suffering from idiopathic generalized epilepsy with primary generalized tonic-clonic (PGTC) seizures in different syndromes (juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening).
Učinkovitost levetiracetama je bila dokazana v 24- tedenski dvojno slepi, s placebom nadzorovani študiji, ki je vključevala odrasle, mladostnike in omejeno število otrok z idiopatsko generalizirano epilepsijo s primarno generaliziranimi tonično- kloničnimi (PGTC) napadi pri različnih sindromih (juvenilna mioklonična epilepsija, juvenilna epilepsija z absencami, otroška epilepsija z absencami ali epilepsija z grand mal napadi pri prebujanju).
21 Levetiracetam is a highly soluble and permeable compound.
Levetiracetam je zelo lahko topna in permeabilna snov.
The extent of absorption is dose-independent and is not altered by food.
21 Obseg absorpcije ni odvisen od odmerka; hrana ga ne spremeni.
In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 and UGT1A6) and epoxide hydroxylase activities.
In vitro so pokazali, da levetiracetam in njegov primarni presnovek ne zavirata aktivnosti glavnih izooblik človeškega jetrnega citokroma P450 (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 in 1A2), glukuronil- transferaze (UGT1A1 in UGT1A6) in epoksid- hidroksilaze.
The in vitro data and in vivo interaction data on oral contraceptives, digoxin and warfarin indicate that no significant enzyme
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 Keppro in drugimi snovmi oz. obratno.
Following single oral dose administration (20 mg/ kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
22 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.
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 corresponding to 30 times the maximum recommended human dose.
V študijah pri novojorenčih in mladičih živali so dokazali, da pri podganah in psih, pri odmerkih do 1800 mg/ kg/ dan, ki ustrezajo 30- kratnemu največjemu priporočenemu odmerku pri ljudeh, ni bilo neželenih učinkov na običajna obdobja razvoja in dozorevanja,
Sodium croscarmellose Macrogol 6000 Colloidal anhydrous silica Magnesium stearate
23 Jedro: premreženi natrijev karmelozat, makrogol 6000, brezvodni koloidni silicijev dioksid, magnezijev stearat
Polyvinyl alcohol-part. hydrolyzed Titanium dioxide (E171) Macrogol 3350 Talc Iron oxide yellow (E172)
Filmska obloga Opadry 85F32004: delno hidroliziran polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec rumeni železov oksid (E172).
24 Keppra 500 mg film-coated tablets are packaged in aluminium/ PVC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Keppra 500 mg filmsko obložene tablete so pakirane v pretisnih omotih aluminij/ PVC, v kartonskih škatlah po 10, 20, 30, 50, 60, 100, 120 in 200 filmsko obloženih tablet.
Keppra 750 mg film-coated tablets.
Keppra 750 mg filmsko obložene tablete
Each film-coated tablet contains 750 mg levetiracetam Excipient: colouring agent E110.
Pomožna snov: barvilo E110.
Orange, oblong, scored and debossed with the code “ ucb” and “ 750” on one side.
Oranžna, podolgovata, z zarezo tableta z vtisnjeno oznako “ ucb˝ in ˝750 ” na eni strani.
26 Elderly (65 years and older)
Starejši (65 let in starejši)
Adjustment of the dose is recommended in elderly patients with compromised renal function (see “ Patients with renal impairment ” below).
Pri starejših bolnikih z okvarjenim delovanjem ledvic je priporočljiva prilagoditev odmerka (glejte spodaj “ Bolniki z ledvično okvaro ”).
Children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg
26 Otroci, stari med 4. in 11. letom, in mladostniki (od 12 do 17 let), težki manj kot 50 kg
The initial therapeutic dose is 10 mg/ kg twice daily.
Začetni terapevtski odmerek je 10 mg/ kg dvakrat na dan.
15 kg (1) 20 kg (1) 25 kg From 50 kg (2) (1)
20 kg 25 kg nad 50 kg (2) (1)
150 mg twice daily 200 mg twice daily 250 mg twice daily 500 mg twice daily
200 mg dvakrat na dan 250 mg dvakrat na dan 500 mg dvakrat na dan
450 mg twice daily 600 mg twice daily 750 mg twice daily 1500 mg twice daily
600 mg dvakrat na dan 750 mg dvakrat na dan 1500 mg dvakrat na dan
27 Dosing adjustment for adult patients with impaired renal function
27 Prilagoditev odmerjanja pri odraslih bolnikih z okvarjenim delovanjem ledvic
Dosage and frequency
odmerjanje in pogostnost
28 Therefore patients should be monitored for signs of depression and/ or suicidal ideation and behaviours and appropriate treatment should be considered.
Zato je treba bolnike med zdravljenjem nadzirati glede znakov depresije in/ ali samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
Keppra 750 mg film-coated tablets contain E110 colouring agent (see section 4.8).
28 Keppra 750 mg filmsko obložene tablete vsebujejo barvilo E110 (glejte poglavje 4. 8).
Therefore, breast-feeding is not recommended.
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
However, if levetiracetam treatment is needed during breastfeeding, the benefit/ risk of the treatment should be weighed considering the importance of breastfeeding.
Ti bolniki morajo biti zato previdni pri izvajanju zahtevnih opravil, npr. pri vožnji
29 4.7 Effects on ability to drive and use machines
29 vozil ali upravljanju strojev.
No studies on the effects on the ability to drive and use machines have been performed.
Bolnikom svetujemo, naj ne vozijo ali upravljajo s stroji, dokler ni potrjeno, da ni vpliva na njihovo sposobnost izvajanja dejavnosti.
Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
4. 8 Neželeni učinki
Pooled safety data from clinical studies conducted with Keppra oral formulations in adult patients with partial onset seizures showed that 46.4% of the patients in the Keppra group and 42.2% of the patients in the placebo group experienced undesirable effects.
Kumulativni varnostni podatki iz kliničnih študij izvedenih na odraslih bolnikih z napadi parcialnega izvora, ki so prejemali peroralne oblike Keppre, kažejo, da so se neželeni učinki pojavili pri 46, 4% bolnikov, ki so prejemali Keppro, in 42, 2% bolnikov, ki so prejemali placebo.
In monotherapy 49.8% of the subjects experienced at least one drug related undesirable effect.
Pri monoterapiji je 49, 8% bolnikov doživelo vsaj en neželeni učinek, povezan z zdravilom.
Common: agitation, depression, emotional lability/ mood swings, hostility/ aggression, insomnia, nervousness/ irritability, personality disorders, thinking abnormal Post-marketing experience: abnormal behaviour, anger, anxiety, confusion, hallucination, psychotic disorder, suicide, suicide attempt and suicidal ideation
− Psihiatrične motnje Pogosti: agitiranost, depresija, čustvena labilnost/ nihanja v razpoloženju, sovražnost/ agresivnost, nespečnost, živčnost/ razdražljivost, osebnostne motnje, motnje mišljenja
Common: abdominal pain, diarrhoea, dyspepsia, nausea, vomiting Post-marketing experience: pancreatitis
30 Postmarketinške izkušnje: nenormalno vedenje, jeza, anksioznost, zmedenost, halucinacije, psihotične motnje, samomor, poskus samomora in razmišljanje o samomoru
- Hepatobiliary disorders:
− Bolezni prebavil Pogosti: bolečina v trebuhu, driska, dispepsija, navzea, bruhanje Postmarketinške izkušnje: pankreatitis
Post-marketing experience: hepatic failure, hepatitis, liver function test abnormal
– Bolezni jeter, žolčnika in žolčevodov Postmarketinške izkušnje: odpoved jeter, hepatitis, nenormalne vrednosti testov jetrnih funkcij
Post-marketing experience: weight loss
Postmarketinške izkušnje: zmanjšanje telesne mase
- Ear and labyrinth disorders
− Ušesne bolezni, vključno z motnjami labirinta Pogosti: vrtoglavica
Common: vertigo
− Očesne bolezni Pogosti: diplopija, zamegljen vid
Common: diplopia, vision blurred
− Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosti: mialgija
- Musculoskeletal and connective tissue disorders
− Poškodbe, zastrupitve in zapleti pri posegih Pogosti: naključna poškodba
Common: myalgia
− Infekcijske in parazitske bolezni Pogosti: okužba, nazofaringitis
- Injury, poisoning and procedural complications
− Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti: okrepljen kašelj
- Infections and infestations
− Bolezni kože in podkožja Pogosti: izpuščaj, ekcem, pruritus Postmarketinške izkušnje: alopecija: v nekaterih primerih so po prekinitvi zdravljenja s Keppro opazili izboljšanje.
Common: infection, nasopharyngitis
− Bolezni krvi in limfatičnega sistema Pogosti: trombocitopenija Postmarketinške izkušnje: levkopenija, nevtropenija, pancitopenija (s supresijo kostnega mozga v posameznih primerih)
- Respiratory, thoracic and mediastinal disorders
Barvilo E110 lahko povzroči alergijske reakcije.
Common: cough increased
4. 9 Preveliko odmerjanje
- Skin and subcutaneous tissue disorders
Simptomi
Common: rash, eczema, pruritus Post-marketing experience: alopecia: in several cases, recovery was observed when Keppra was discontinued.
Pri prevelikem odmerjanju Keppre so opažali zaspanost, agitiranost, agresivnost, zmanjšano stopnjo zavesti, depresijo dihanja in komo.
- Blood and lymphatic system disorders
Obvladovanje prevelikega odmerjanja
Common: thrombocytopenia Post-marketing experience: leukopenia, neutropenia, pancytopenia (with bone marrow suppression identified in some of the cases)
Specifičnega antidota za levetiracetam ni.
E 110 coloring agent may cause allergic reactions.
Zdravljenje prevelikega odmerjanja je simptomatsko in
31 Symptoms
31 lahko vključuje hemodializo.
The mechanism of action of levetiracetam still remains to be fully elucidated but appears to be different from the mechanisms of current antiepileptic medicinal products.
Mehanizem delovanja levetiracetama še vedno ni popolnoma pojasnjen, vendar kaže, da je drugačen od mehanizmov drugih protiepileptičnih zdravil.
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%,
Delež bolnikov iz zbranih analiz, pri katerih je bilo doseženo 50 ali več odstotno zmanjšanje pogostnosti napadov parcialnega izvora na teden pri stalnem odmerku (12/ 14 tednov), je bil 27, 7% pri bolnikih, ki so prejemali 1000 mg, 31, 6% pri bolnikih, ki so prejemali 2000 mg in 41, 3% pri bolnikih, ki so prejemali 3000 mg levetiracetama, ter 12, 6% pri bolnikih, ki so prejemali placebo.
Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
32 Samostojno zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri bolnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo
Six-month seizure freedom was achieved in 73.0% of levetiracetam-treated patients and 72.8% of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2% (95% CI: -7.8 8.2).
7, 8- 8, 2).
More than half of the subjects remained seizure free for 12 months (56.6% and 58.5% of subjects on levetiracetam and on carbamazepine CR respectively).
Več kot polovica preiskovancev 12 mesecev ni imela napadov (56, 6% preiskovancev, ki so prejemali levetiracetam, in 58, 5% preiskovancev, ki so prejemali karbamazepin z nadzorovanim sproščanjem).
With continued long-term treatment, 47.4% of
Pri 72, 2% bolnikov, ki so se zdravili z levetiracetamom, in 45, 2% bolnikov, ki so prejemali placebo, je bilo 50 ali več odstotno zmanjšanje pogostnosti PGTC napadov na teden.
33 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.
Z nadaljevanjem dolgotrajnega zdravljenja je bilo 47, 4% bolnikov brez tonično- kloničnih napadov vsaj 6 mesecev, 31, 5% pa jih je bilo brez tonično- kloničnih napadov vsaj 1 leto.
A significant correlation between saliva and plasma concentrations has been shown in adults and children (ratio of saliva/ plasma concentrations ranged from 1 to 1.7 for oral tablet formulation and after 4 hours post-dose for oral solution formulation).
33 Pri odraslih in otrocih so pokazali pomembno povezavo med koncentracijo v plazmi in slini (razmerje koncentracij slina/ plazma se giblje med 1 in 1, 7 za tableto in peroralno raztopino 4 ure po odmerku).
34 In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1.
V kulturi človeških hepatocitov je imel levetiracetam majhen učinek ali pa ni imel učinka na CYP1A2, SULT1E1 ali UGT1A1.
Therefore, the interaction of Keppra with other substances, or vice versa, is unlikely.
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 Keppro in drugimi snovmi oz. obratno.
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.
34 Ledvični očistek levetiracetama 0, 6 ml/ min/ kg in njegovega primarnega presnovka ucb L057 4, 2 ml/ min/ kg kažeta na to, da se levetiracetam izloča z glomerulno filtracijo, ki ji sledi tubularna reabsorpcija, primarni presnovek pa se poleg glomerulne filtracije izloča tudi z aktivno tubularno sekrecijo.
Following single oral dose administration (20 mg/ kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
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.
35 Hepatic impairment
Jetrna okvara
In reproductive toxicity studies in the rat, levetiracetam induced developmental toxicity (increase in skeletal variations/ minor anomalies, retarded growth, increased pup mortality) at exposure levels similar to or greater than the human exposure.
Pri kuncih so v
In the rabbit foetal effects (embryonic death, increased skeletal anomalies, and increased malformations) were observed in the presence of maternal toxicity.
35 primeru toksičnosti pri materi opažali učinke na plod (smrt zarodkov, številnejše anomalije okostja in številnejše malformacije).
Magnesium stearate
Jedro: premreženi natrijev karmelozat, makrogol 6000, brezvodni koloidni silicijev dioksid, magnezijev stearat
Polyvinyl alcohol-part. hydrolyzed Titanium dioxide (E171) Macrogol 3350 Talc Sunset yellow FCF aluminium lake (E110) Iron oxide red (E172)
Filmska obloga Opadry 85F23452: delno hidroliziran polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec, rdeči železov oksid (E172) oranžno FCF (E110)
36 No special precautions for storage.
Za shranjevanje ni posebnih navodil.
Keppra 750 mg film-coated tablets are packaged in aluminium/ PVC blisters placed into cardboard boxes containing 20, 30, 50, 60, 80, 100 and 200 film-coated tablets.
Keppra 750 mg filmsko obložene tablete so pakirane v pretisnih omotih aluminij/ PVC, v kartonskih škatlah po 20, 30, 50, 60, 80, 100 in 200 filmsko obloženih tablet.
Keppra 1000 mg film-coated tablets.
Keppra 1000 mg filmsko obložene tablete
Each film-coated tablet contains 1,000 mg levetiracetam.
Ena filmsko obložena tableta vsebuje 1. 000 mg levetiracetama.
For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglevje 6. 1.
White, oblong, scored and debossed with the code “ ucb” and “ 1000” on one side.
Bela, podolgovata, z zarezo tableta z vtisnjeno oznako “ ucb˝in ˝1000 ” na eni strani.
• Monotherapy Adults and adolescents from 16 years of age
• Monoterapija Odrasli in mladostniki od 16. leta starosti
38 Adjustment of the dose is recommended in elderly patients with compromised renal function (see “ Patients with renal impairment ” below).
Pri starejših bolnikih z okvarjenim delovanjem ledvic je priporočljiva prilagoditev odmerka (glejte spodaj “ Bolniki z ledvično okvaro ”).
The initial therapeutic dose is 10 mg/ kg twice daily.
38 Začetni terapevtski odmerek je 10 mg/ kg dvakrat na dan.
20 kg 25 kg From 50 kg (2) (1)
15 kg (1) 20 kg (1) 25 kg nad 50 kg (2) (1)
200 mg twice daily 250 mg twice daily 500 mg twice daily
150 mg dvakrat na dan 200 mg dvakrat na dan 250 mg dvakrat na dan 500 mg dvakrat na dan
600 mg twice daily 750 mg twice daily 1500 mg twice daily
450 mg dvakrat na dan 600 mg dvakrat na dan 750 mg dvakrat na dan 1500 mg dvakrat na dan
[140-age( years)] x weight (kg) CLcr (ml/ min) = ----------------------------------------- 72 x serum creatinine (mg/ dl)
[140 – starost (leta)] x masa (kg) CLcr (ml/ min) = ------------------------------------------------------------- (x 0, 85 za ženske) 72 x koncentracija kreatinina v serumu (mg/ dl)
39 Dosing adjustment for adult patients with impaired renal function
Prilagoditev odmerjanja pri odraslih bolnikih z okvarjenim delovanjem ledvic
For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function.
39 Pri otrocih z ledvično okvaro je treba odmerek levetiracetama prilagoditi glede na delovanje ledvic, kajti z njihovim delovanjem je povezan tudi očistek levetiracetama.
40 Therefore patients should be monitored for signs of depression and/ or suicidal ideation and behaviours and appropriate treatment should be considered.
Zatoje treba bolnike med zdravljenjem nadzirati glede znakov depresije in/ ali samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite but not of levetiracetam.
40 Ugotovili so, da probenecid (500 mg štirikrat na dan), ki blokira ledvično tubularno sekrecijo, zavre ledvični očistek primarnega presnovka, ne pa levetiracetama.
41 No studies on the effects on the ability to drive and use machines have been performed.
Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.