qanastek/EMEA-V3 huggingface dataset:
The marketing authorisation was renewed on 29 September 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid- 29 ta ’ Settembru 2005.
The marketing authorisation holder is UCB Pharma SA.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq huwa UCB Pharma SA.
The full EPAR for Keppra is available here.
L- EPAR sħiħ għal Keppra jista ’ jinkiseb minn hawnhekk.
Keppra 250 mg film-coated tablets.
Keppra 250 mg pilloli miksija b' rita.
Each film-coated tablet contains 250 mg levetiracetam.
Kull pillola miksija b' rita fiha 250 mg levetiracetam.
For a full list of excipients, see section 6.1.
Għal lista sħiħa tas- sustanzi mhux attivi, ara sezzjoni 6. 1.
Blue, oblong, scored and debossed with the code “ ucb” and “ 250” on one side.
Blu, tawwalija, maqtuha minn nofs u mnaqqxa bil- kodiċi “ ucb ” u ” 250 ” fuq naħa waħda.
Keppra is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Keppra huwa indikat biex ikun użat bħala monoterapija fit- trattament ta 'aċċessjonijiet tat- tip parzjali kemm meta jkun hemm, kif ukoll meta ma jkunx hemm ġeneralizzazzjoni sekondarja f' pazjenti li għandhom minn 16 il- sena li għadhom kif ġew dijanjostikati b ’ epilessija.
Keppra is indicated as adjunctive therapy • in the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy. • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Keppra huwa indikat biex ikun użat bħala parti mit- terapija • fit- trattament ta 'aċċessjonijiet tat- tip parzjali kemm meta jkun hemm, kif ukoll meta ma jkunx hemm ġeneralizzazzjoni sekondarja f’ adulti u tfal minn 4 snin b’ epilessija. • fit- trattament ta ’ aċċessjonijiet tat- tip mijokloniċi f’ adulti u addoloxxenti minn 12 snin b’ epilessija tat- tip Mijoklonika li tibda fiż- żgħożija • Fit- trattament ta ’ aċċessjonijiet primarji u ġeneralizzati tat- tip tonic- clonic f’ adulti u addoloxxenti minn 12 il- sena b’ Epilessija Ġeneralizzata Idjopatika.
The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food.
Tiblaħhom ma biżżejjed ilma kemm ma 'l- ikel u kif ukoll fuq stonku vojt.
The daily dose is administered in two equally divided doses.
Id- doża ta 'kuljum tinqasam f' żewġ dożi indaqs.
• Monotherapy Adults and adolescents from 16 years of age
• Monoterapija Adulti u Adoloxxenti minn 16- il sena ‘ l fuq.
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.
Id- doża rikkmandata tal- bidu hi ta ’ 250 mg darbtejn kuljum li għandha tiżdied għal doża terapewtika iniżjali ta ’ 500mg darbtejn kuljum wara ġimgħatejn.
The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response.
Id- doża tista ’ tkompli tiżdied b ’ 250 mg darbtejn kuljum kull ġimagħtejn skond ir- rispons kliniku.
The maximum dose is 1500 mg twice daily.
Id- doża massima hi ta ’ 1500 mg darbtejn kuljum.
• Add-on therapy Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more
• Terapija miżjuda Adulti (≥18 sena) u addoloxxenti (12 sa 17 il- sena) li jiżnu iżjed minn 50 kg jew iżjed.
The initial therapeutic dose is 500 mg twice daily.
Id- doża tal- bidu hija ta '500 mg darbtejn kuljum.
This dose can be started on the first day of treatment.
Din id- doża tista 'tibda tittieħed mill- ewwel ġurnata tat- trattament.
Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily.
Id- doża ta 'kuljum tista' tiġi miżjuda jew mnaqqsa għal massimu ta '1, 500 mg darbtejn kuljum, skond ir- respons kliniku u skond kemm il- mediċina tkun indrat mill- pazjent.
Dose changes can be made in 500 mg twice daily increases or decreases every two to four weeks.
Tibdil fid- doża jista 'jsir kull ġimagħtejn sa erba' ġimgħat u tista 'tiżdied jew titnaqqas b’ 500 mg darbtejn kuljum.
Elderly (65 years and older)
Anzjani (65 sena u fuqhom)
2 Adjustment of the dose is recommended in elderly patients with compromised renal function (see “ Patients with renal impairment ” below).
2 Hu rrikkmandat li f 'pazjenti anzjani li għandhom funzjoni mnaqqsa tal- kliewi, tiġi aġġustata d- doża (ara “ Pazjenti b’ indeboliment tal- kliewi ” hawn taħt).
Children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg
Tfal ta ’ 4 sa 11 il- sena u addoloxxenti (12 sa 17 il- sena) li jiżnu inqas minn 50 kg
The initial therapeutic dose is 10 mg/ kg twice daily.
Id- doża terapewtika tal- bidu hija 10 mg/ kg darbtejn kuljum.
Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/ kg twice daily.
Id- doża ta 'kuljum tista' tiġi miżjuda jew mnaqqsa għal massimu ta '30 mg/ kg darbtejn kuljum, skond ir- respons kliniku u skond kemm il- mediċina tkun indrat mill- pazjent.
Dose changes should not exceed increases or decreases of 10 mg/ kg twice daily every two weeks.
Tibdil fid- doża ma jistgħux ikunu iżjed min żieda jew tnaqqis ta ’ 10 mg/ kg darbtejn kuljum kull ġimagħtejn.
The lowest effective dose should be used.
L- iżgħar doża effettiva għandha tintuża.
Dosage in children 50 kg or greater is the same as in adults.
Id- dożaġġ fit- tfal ta ’ 50 kg jew iżjed huma l- istess bħal dik fl- adulti.
The physician should prescribe the most appropriate pharmaceutical form and strength according to weight and dose.
It- tabib għandu jqis il- piż u d- doża, sabiex jikteb il - mediċina bl- aħjar għamla farmaċewtika u saħħa.
Dosage recommendations for children and adolescents:
Dożaġġ rikkmandat għal tfal u addoloxxenti
Starting dose:
Doża tal- bidu:
10 mg/ kg twice daily
10 mg/ kg darbtejn kuljum
Maximum dose:
Doża Massima:
30 mg/ kg twice daily
450 mg darbtejn kuljum
15 kg (1) 20 kg (1) 25 kg From 50 kg (2) (1)
20 kg 25 kg Minn 50 kg (2) (1)
150 mg twice daily 200 mg twice daily 250 mg twice daily 500 mg twice daily
200 mg darbtejn kuljum 250 mg darbtejn kuljum 500 mg darbtejn kuljum
450 mg twice daily 600 mg twice daily 750 mg twice daily 1500 mg twice daily
600 mg darbtejn kuljum 750 mg darbtejn kuljum 1500 mg darbtejn kuljum
Children 20 kg or less should preferably start the treatment with Keppra 100 mg/ ml oral solution.
Tfal ta ’ 20 kg jew inqas għandhom preferabilment jibdew it- trattament b ’ Keppra 100 mg/ ml soluzzjoni orali.
(2) Dosage in children and adolescents 50 kg or more is the same as in adults.
(2) Id- dożaġġ fit- tfal u addoloxxenti ta ’ 50 kg jew iżjed hija l- istess bħal dik fl- adulti.
Infants and children less than 4 years
Trabi u tfal taħt l- 4 snin
Keppra is not recommended for use in children below 4 years of age due to insufficient data on safety and efficacy (see section 5.2).
Keppra mhux rikkmandat għall- użu fit- tfal taħt l- 4 snin minħabba li m’ hemmx biżżejjed tagħrif fuq is- sigurta` u l- effikaċja (ara sezzjoni 5. 2).
The daily dose must be individualised according to renal function.
Id- doża li tingħata kuljum tiddependi mill- funzjoni tal- kliewi ta 'kull pazjent individwali.
For adult patients, refer to the following table and adjust the dose as indicated.
Għal pazjenti adulti, imxi ma 'l- iskeda hawn taħt biex tkun tista' tagħmel tibdil fid- doża.
To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/ min is needed.
Biex tuża din l- iskeda hemm bzonn tkun taf l- estimu tar- rata li biha titneħħa il- krejatinina (CLcr) f 'ml/ min fil - pazjent.
The CLcr in ml/ min may be estimated from serum creatinine (mg/ dl) determination using the following formula:
Din ir- rata tista 'tigi kkalkulata mill- livell ta' krejatinina fis- serum (mg/ dl) billi tuża din il - formula:
[140-age (years)] x weight (kg) CLcr (ml/ min) = ----------------------------------------- 72 x serum creatinine (mg/ dl)
[140 - eta` (snin)] x piż (kg) Clcr (ml/ min) = ------------------------------------------------ (x 0. 85 għan- nisa) 72 x livell ta 'krejatinina fis- serum (mg/ dl)
Then CLcr is adjusted for body surface area (BSA) as follows:
Imbagħad, CLcr huwa aġġustat għall- erja tas- superfiċje tal- ġisem (BSA) bħal hawn taħt:
CLcr (ml/ min) CLcr (ml/ min/ 1.73 m2) = ---------------------------- x 1.73 BSA subject (m2)
CLcr (ml/ min) 2 CLcr (ml/ min/ 1. 73 m) = ---------------------------- x 1. 73 BSA pazjent (m2)
3 Dosing adjustment for adult patients with impaired renal function
3 Regolar tad- doża f' pazjenti adulti bi ħsara fil- kliewi
Creatinine clearance (ml/ min/ 1.73m2)
Rata ta 'tneħħija tal - krejatinina (ml/ min/ 1. 73m2)
Dosage and frequency
Doża u frekuenza
Normal Mild Moderate Severe End-stage renal disease patients Undergoing dialysis (1)
Normali
> 80 50-79 30-49 < 30 -
> 80 500 sa
500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 250 to 500 mg twice daily 500 to 1,000 mg once daily (2)
1, 500 mg darbtejn kuljum
(1) A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.
1, 000 mg darbtejn kuljum
(2) Following dialysis, a 250 to 500 mg supplemental dose is recommended.
(2) Wara id- dijaliżi, hija rrikkmandata doża supplimentari ta 'bejn 250 u 500 mg.
For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function.
F ’ tfal b’ indeboliment tal- kliewi, id- doża ta ’ levetiracetam għandha tiġi aġġustata skond il- funzjoni renali għaliex clearance ta ’ levetiracetam huwa marbut mal- funzjoni renali.
This recommendation is based on a study in adult renally impaired patients.
Din ir- rekkomandazzjoni hija bażata fuq studju li sar f’ pazjenti b’ indeboliment tal- kliewi.
Patients with hepatic impairment
Pazjenti b’ indeboliment tal- fwied
No dose adjustment is needed in patients with mild to moderate hepatic impairment.
M' hemmx għalfejn tibdil fid- doża ta 'pazjenti bi ħsara ħafifa għal moderata fil- fwied.
In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency.
F' pazjenti bi ħsara severa fil- fwied, r- rata li biha titneħħa l- krejatinina tista 'taħbi il- veru nuqqas fil- funzjoni tal - kliewi.
Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is < 70 ml/ min.
Għalhekk huwa rrikkmandat li meta r- rata li biha titneħħa l- krejatinina tkun < 70ml/ min, għandu jkun hemm tnaqqis ta '50% tad- doża ta' kuljum.
Hypersensitivity to levetiracetam or other pyrrolidone derivatives or any of the excipients.
Sensittività eċċessiva għal levetiracetam jew derivattivi oħrajn ta 'pyrrolidone, jew għal xi sustanzi mhux attivi.
In accordance with current clinical practice, if Keppra has to be discontinued it is recommended to withdraw it gradually (e. g. in adults:
Kif isir normalment fil- prattika klinika fil- present, jekk ikun ser jitwaqqaf it- trattament b 'Keppra, huwa rrikkmandat li dan isir bil- mod (ez.
500 mg decreases twice daily every two to four weeks; in children: dose decrease should not exceed 10 mg/ kg twice daily every two weeks).
F ’ adulti: tnaqqis ta '500 mg darbtejn kuljum kull ġimagħtejn sa erba' ġimgħat; f’ tfal: it- tnaqqis fid- doża m’ għandiex tkun iżjed minn 10 mg/ kg darbtejn kuljum kull ġimagħtejn).
An increase in seizure frequency of more than 25% was reported in 14% of levetiracetam treated adult and paediatric patients with partial onset seizures, whereas it was reported in 26% and 21% of placebo treated adult and paediatric patients, respectively.
Żieda fil- frekwenza ta ’ l- aċċessjonijiet ta 'iżjed minn 25% gie rapportat f' 14% tal- pazjenti adulti fuq levetiracetam u f ’ pazjenti pedjatriċi b’ aċċessjonijiet tat- tip parzjali, waqt li kienet rappurtata f '26% u 21% fil- pazjenti adulti u pedjatriċi rispettivament, li ngħataw plaċebo.
When Keppra was used to treat primary generalised tonic-clonic seizures in adults and adolescents with idiopathic generalised epilepsy, there was no effect on the frequency of absences.
Meta Keppra ntuża fit- trattament ta ’ aċċessjonijiet primarji tat- tip tonic- clonic f’ adulti u addoloxxenti b ’ epilessija ġeneralizzata idjopatika, ma kienx hemm effett fuq il- frekwenza ta ’ absences.
The administration of Keppra to patients with renal impairment may require dose adjustment.
Jista 'jkun hemm bżonn ta' tibdil fid- doża meta Keppra jingħata lil pazjenti bi ħsara fil- kliewi.
In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection (see section 4.2).
F 'każi fejn ikun hemm ħsara severa fil- fwied, huwa rrikkmandat li jsir eżami tal- funzjoni tal- kliewi qabel ma tiġi deċiża d- doża (ara sezzjoni 4. 2).
Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam).
Suwiċidju, attentat ta ’ suwiċidju, ħsibijiet u mġieba suwiċidali kienu rrappurtati f’ pazjenti trattati b ’ mediċini ta ’ kontra l- epilessija (inkluż levetiracetam).
A meta-analysis of randomized placebo-controlled trials of anti-epileptic drugs has shown a small increased risk of suicidal thoughts and behaviour.
Meta- analiżi ta ’ provi randomized u kkontrollati mill- plaċebo ta ’ mediċini ta ’ kontra l- epilessija juri żieda żgħira fil- ħsibijiet u mġieba suwiċidali.
The mechanism of this risk is not known.
Il - mekkaniżmu ta ’ dan ir- riskju mhux magħruf.
Therefore patients should be monitored for signs of depression and/ or suicidal ideation and behaviours and appropriate treatment should be considered.
Għalhekk il- pazjenti għandhom jiġu ċċekkjati għal sinjali ta ’ depressjoni u/ jew ħsibijiet u mġieba suwiċidali u għandu jitqies trattament xieraq.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/ or suicidal ideation or behaviour emerge.
Il- pazjenti (u dawk li jieħdu ħsieb il- pazjenti) għandhom jingħataw il- parir li jfittxu parir mediku jekk jitfaċċaw sinjali ta ’ depressjoni u/ jew ħsibijiet u mġieba suwiċidali.
Pre-marketing data from clinical studies conducted in adults indicate that Keppra did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of Keppra.
Tagħrif minn studji kliniċi f’ adulti li saru qabel ma ħareġ fis- suq, juri li Keppra ma kellu ebda effett fuq il- konċentrazzjonijiet ta 'mediċini eżistenti kontra l- epilessija (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin u primidone), u li dawn il- prodotti ma kellhom ebda effett fuq il- profil farmakokinetiku ta' Keppra.
As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/ kg/ day levetiracetam.
Bħal fl- adulti, m’ hemm ebda evidenza klinikament sinifikanti ta ’ effetti ta ’ mediċini oħra f ’ pazjenti pedjatriċi li jieħdu sa 60 mg/ kg/ ġurnata ta ’ levetiracetam.
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.
Studju retrospettiv ta ’ interazzjoni farmakokinetika fit- tfal u l- addoloxxenti b’ epilessija (4 sa 17 il - sena) ikkonferma li terapija miżjuda b ’ levetitacetam li jittieħed mill- ħalq ma kellux effett fuq konċentrazzjonijiet tas- serum fi stat fiss ta ’ carbamazepine u valproate li jingħataw fl- istess ħin.
Dosage adjustment is not required.
M’ hemmx bżonn aġġustament tad- doża.
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.
Ġie muri li probenecid li jwaqqaf il- passaġġ attiv ta 'ċerti sustanzi għal ġot- tubules tal- kliewi, f’ dożi ta’ 500 mg erba' darbiet kuljum, m' għandu ebda effett fuq levetiracetam.
Nevertheless, the concentration of this metabolite remains low.
Probenecid f' dawn id- dożi iwaqqaf it- tneħħija mill- kliewi tal- prodott ewlieni tal- metaboliżmu ta 'levetiracetam, imma madanakollu l- konċentrazzjoni tiegħu xorta tibqa' żgħira.
It is expected that other medicinal products excreted by active tubular secretion could also reduce the renal clearance of the metabolite.
Huwa mistenni li mediċini oħrajn li huma mneħħija mill- ġisem permezz ta 'passaġġ attiv mill- kliewi, jistgħu wkoll inaqqsu t- tneħħija ta' dan il - prodott tal- metaboliżmu mill- kliewi.
The effect of levetiracetam on probenecid was not studied and the effect of levetiracetam on other actively secreted medicinal products, e. g.
L- effett ta 'levetiracetam fuq probenecid ma kienx studjat.
NSAIDs, sulfonamides and methotrexate, is unknown.
Mhux magħruf ukoll l- effett ta 'levetiracetam fuq mediċini oħrajn li huma mneħħija mill- ġisem permezz ta' passaġġ attiv, eż. il- mediċini kontra l- infjammazzjoni mhux sterojdi, is- sulfonamidi u methotrexate.
Co-administration with digoxin, oral contraceptives and warfarin did not influence the pharmacokinetics of levetiracetam.
M' hemmx ebda tagħrif fuq l- effett ta 'mediċini ta' kontra l- aċidu fl- istonku fuq l- assorbiment ta 'levetiracetam.
No data on the influence of antacids on the absorption of levetiracetam are available.
L- ikel ma kellu ebda effett fuq l- assorbiment ta 'levetiracetam, izda r- rata kienet ħarira mnaqqsa.
No data on the interaction of levetiracetam with alcohol are available.
M' hemmx tagħrif dwar jekk jaqbilx levetiracetam ma 'l- alkoħol.
There are no adequate data from the use of Keppra in pregnant women.
M' hemmx tagħrif xieraq fuq l- użu ta 'Keppra f' nisa tqal.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji f' annimali wrew tossiċità fuq is - sistema riproduttiva (ara sezzjoni 5. 3).
The potential risk for human is unknown.
Ir- riskju potenzjali għall- bniedem mhux magħruf.
Keppra should not be used during pregnancy unless clearly necessary.
Keppra m' għandux jintuża waqt it- tqala sakemm mhux veru neċessarju.
As with other antiepileptic drugs, physiological changes during pregnancy may affect levetiracetam concentration.
Bħal mediċini ta ’ kontra l- epilessija oħra, tibdil fiżjoloġiku waqt it- tqala jista ’ jkollu effett fuq il - konċentrazzjoni ta ’ levetiracetam.
Decrease in levetiracetam plasma concentrations has been observed during pregnancy.
Ġie osservat tnaqqis fil- konċentrazzjoni ta ’ levetiracetam fil- plażma waqt it- tqala.
This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy).
Dan it- tnaqqis kien akbar waqt it- tielet trimester (sa 60% tal- konċentrazzjoni tal- linja bażi qabel it- tqala).
Appropriate clinical management of pregnant women treated with levetiracetam should be ensured.
Irid jiġi assigurat immaniġġjar kliniku xieraq tan- nisa tqal trattati b’ levetiracetam.
Discontinuation of antiepileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus.
Meta jitwaqqaf it- trattament ta 'kontra l- epilessija, il- kundizzjoni medika tista' tmur għall- agħar u għalhekk tista ’ tkun ta 'ħsara għall- omm u l- fetu.
Therefore, breast-feeding is not recommended.
Levetiracetam jitneħħa fil- ħalib ta ’ l- omm, għalhekk l- irdigħ mhux irrikkmandat.
However, if levetiracetam treatment is needed during breastfeeding, the benefit/ risk of the treatment should be weighed considering the importance of breastfeeding.
Madanakollu, jekk ikun hemm bżonn trattament b’ levetiracetam waqt it- treddigħ, irid jitqies il - benefiċċju/ riskju tat- trattament peress li t- treddigħ huwa importanti.
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 5 increase.
Speċjalment fil- bidu tat - trattament jew wara żieda fid- doża, xi pazjenti li possibilment ikunu iżjed sensittivi, jistgħu jitħeddlu jew iħossu sintomi oħrajn relatati mas- sistema nervuża ċentrali.
Therefore, caution is recommended in those patients when performing skilled tasks, e. g. driving vehicles or operating machinery.
Għalhekk, attenzjoni speċjali hi rrikkmandata f' dawn il- pazjenti meta jkunu qed jagħmlu xogħolijiet ta 'ċertu ħila, ez. sewqan ta' vetturi jew tħaddim ta 'makkinarju.
Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
Il- pazjenti jingħataw parir biex ma jsuqux jew jużgħux magni sakemm ma jiġi stabbilit li mhux affetwat il- ħila tagħhom li jagħmlu dawn l- attivitajiet.
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.
Tagħrif dwar is- sigurtà li ġiet miġbura minn studji kliniċi li saru b ’ pazjenti adulti b’ aċċessjonijiet tat - tip parzjali fuq Keppra li jittieħed bil- ħalq, turi li 46. 4% tal- grupp ta ’ pazjenti fuq Keppra u 42. 2% tal - grupp ta ’ pazjenti fuq plaċebo, kellhom xi effetti mhux mixtieqa.
Serious undesirable effects were experienced in 2.4% of the patients in the Keppra and 2.0% of the patients in the placebo groups.
2. 4% tal- grupp ta ’ pazjenti fuq Keppra u 2. 0% tal- grupp ta ’ pazjenti fuq plaċebo kellhom effetti serji.
The most commonly reported undesirable effects were somnolence, asthenia and dizziness.
L- izjed effetti mhux mixtieqa li gew irraportati kienu ħedla, għajja, u sturdament.
In the pooled safety analysis, there was no clear dose-response relationship but incidence and severity of the central nervous system related undesirable effects decreased over time.
Analiżi ta ’ l- istudji dwar is- sigurta miġbura wrew li ma kien hemm ebda relazzjoni ċara bejn id- doża u l- effett, imma li n- numru u s- severità ta ’ l- effetti fuq is- sistema nervuża ċentrali naqsu maż- żmien.
In monotherapy 49.8% of the subjects experienced at least one drug related undesirable effect.
F’ monoterapija 49. 8% tal- pazjenti kellhom mill- inqas effett wieħed mhux mixtieq.
The most frequently reported undesirable effects were fatigue and somnolence.
L- aktar effetti mhux mixtieqa li ħew rappurtati spiss kienu għajj u nagħas.
A study conducted in paediatric patients (4 to 16 years) with partial onset seizures showed that 55.4% of the patients in the Keppra group and 40.2% of the patients in the placebo group experienced undesirable effects.
Studju li sar f’ pazjenti pedjatriċi (4 sa 16 il- sena) b ’ aċċessjonijiet tat- tip parzjali juru li 55. 4% tal - pazjenti fil- grupp ta ’ Keppra u 40. 2% tal- pazjenti fil- grupp tal- plaċebo kellhom effetti mhux mixtieqa.
Serious undesirable effects were experienced in 0.0% of the patients in the Keppra group and 1.0% of the patients in the placebo group.
0. 0% mill- pazjenti fil- grupp ta ’ Keppra u 1. 0% ta ’ pazjenti fil- grupp ta ’ plaċebo kellhom effetti mhux mixtieqa serji.
The most commonly reported undesirable effects were somnolence, hostility, nervousness, emotional lability, agitation, anorexia, asthenia and headache in the paediatric population.
L- iżjed effetti mhux mixtieqa serji fil- popolazzjoni pedjatrika, kienu nagħas, ostilita`, nervożiżmu, instabbilta` emozzjonali, aġitazzjoni, anoressija, astenja u uġigħ ta ’ ras.
Safety results in paediatric patients were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse events which were more common in children than in adults (38.6% versus 18.6%).
Risultati dwar sigurta` f’ pazjenti pedjatriċi kienu konsistenti mal- profil ta ’ sigurta` ta ’ levetiracetam f’ adulti minn barra minn effetti mhux mixtieqa fl- aġir u psikjatriċi li keinu iżjed komuni fit- tfal minn fl- adulti (3806% versus 18. 6%).
However, the relative risk was similar in children as compared to adults.
Iżda, ir- riskju relattiv kien simili fit- tfal meta mqabbel ma ’ l- adulti.
A study conducted in adults and adolescents with myoclonic seizures (12 to 65 years) showed that 33.3% of the patients in the Keppra group and 30.0% of the patients in the placebo group experienced undesirable effects that were judged to be related to treatment.
Studju li sar f’ adulti u addoloxxenti b’ aċċessjonijiet mijokloniċi (12 sa 65 sena) wera li 33. 3% tal – pazjenti fil- grupp tal- Keppra u 30. 0% fil- grupp tal- plaċebo kellhom effetti mhux mixtieqa meqjusa li kellhom x’ jaqsmu mat- trattament.
The most commonly reported undesirable effects were headache and somnolence.
L- iżjed effetti mhux mixtieqa li ġew rappurtati kienu uġigħ ta ’ ras u nagħas.
The incidence of undesirable effects in patients with myoclonic seizures was lower than that in adult patients with partial onset seizures (33.3% versus 46.4%).
L- inċidenza ta ’ effetti mhux mixtieqa f’ pazjenti b’ aċċessjonijiet mijokloniċi kien iżgħar minn dak f’ pazjenti b’ aċċessjonijiet tat- tip parzjali (33. 3% versus 46. 4%).
A study conducted in adults and children (4 to 65 years) with idiopathic generalised epilepsy with primary generalised tonic-clonic seizures showed that 39.2% of the patients in the Keppra group and 29.8% of the patients in the placebo group experienced undesirable effects that were judged to be related to treatment.
Studju li sar f’ adulti u tfal b’ epilessija ġeneralizzata idjopatika b’ aċċessjonijiet primarji ġeneralizzati tat- tip tonic- clonic wera li 39. 2% tal – pazjenti fil- grupp tal- Keppra u 29. 8% fil- grupp tal- plaċebo kellhom effetti mhux mixtieqa meqjusa li kellhom x’ jaqsmu mat- trattament.
The most commonly reported undesirable effect was fatigue.
L- iżjed effett mhux mixtieq li ġie rappurtat kien għajja.
Undesirable effects reported in clinical studies (adults and children) or from post-marketing experience are listed in the following table per System Organ Class and per frequency.
Fl- iskeda hawn taħt hawn il- lista ta ’ l- effetti mhux mixtieqa li gew rapportati fi studji kliniċi (adulti u tfal) u wara l- użu tal- prodott fis- suq.
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, 000), jinkludi rapporti iżolati.
Data from post-marketing experience are insufficient to support an estimate of their incidence in the population to be treated.
M' hemmx biżżejjed tagħrif dwar l- użu tal- prodott fis- suq biex issir estimu fuq l- inċidenza ta ’ l- effetti fil- popolazzjoni.
- General disorders and administration site conditions
- Mard ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Very common: asthenia/ fatigue
Komuni ħafna: astenja/ għajja.
- Nervous system disorders
- Mard tas- sistema nervuża
Very common: somnolence Common: amnesia, ataxia, convulsion, dizziness, headache, hyperkinesia, tremor, balance disorder, disturbance in attention, memory impairment.
Komuni ħafna: ħedla Komuni: amneżija, ataksja (movimenti mhux ko- ordinati), aċċessjoni, sturdament, uġigħ ta 'ras, iperkineżja, rogħda, mard tal- bilanċ, disturbi fl- attenzjoni u telf ta ’ memorja.
Post-marketing experience: paraesthesia
Esperjenza wara li l- użu tal- prodott fis- suq: para- astenja
- Psychiatric disorders
- Mard psikjatriku
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
Komuni: aġitazzjoni, depressjoni, disturbi emozzjonali, tibdil fil- burdata, ostilità / aggressjoni, nuqqas ta 'rqad, nervożita` / irritabilita`, disturbi fil- personalita`, ħsieb mhux normali Esperjenza wara l- użu fis- suq: mġieba mhux normali, rabja, ansjetà, konfużjoni, alluċinazzjonijiet, disturbi psikotiċi, attentati ta’ suwiċidju u ħsieb ta ’ suwiċidju
- Gastrointestinal disorders
- Mard gastro- intestinali
Common: abdominal pain, diarrhoea, dyspepsia, nausea, vomiting Post-marketing experience: pancreatitis
6 Komuni: uġigħ fl- addomenu, dijarrea, indiġestjoni, dardir, rimettar Esperjenza wara li l- użu tal- prodott fis- suq: pankreatite
- Hepatobiliary disorders:
- Mard tal- fwied u tal- marrara
Post-marketing experience: hepatic failure, hepatitis, liver function test abnormal
Esperjenza wara li l- użu tal- prodott fis- suq: insuffiċjenza tal- fwied, epatite, riżultat abnormali tat- test tal- funzjoni epatika
- Metabolism and nutrition disorders
- Mard fil- metaboliżmu u fin- nutrizzjoni
The risk of anorexia is higher when topiramate is coadministered with levetiracetam.
komuni: anoressija, żieda fil- piz Ir- riskju ta ’ anoressija huwa iżjed meta jingħata topiramate ma ’ levetiracetam.
Post-marketing experience: weight loss
Esperjenza wara li l- użu tal- prodott fis- suq: telf ta ’ piz
- Ear and labyrinth disorders
- Mard fil- widna u labirintika
Common: vertigo
Komuni: vertigo
- Eye disorders
- Mard fl- għajn
Common: diplopia, vision blurred
Komuni: viżjoni doppja, viżjoni mċajpra
- Musculoskeletal and connective tissue disorders
- Mard muskolu- skeltrali u tal- connective tissue
Common: myalgia
Komuni: majalġja
- Injury, poisoning and procedural complications
- Korriment, avvelenament u kumplikazzjonijiet proċedurali
Common: accidental injury
Komuni: korriment aċċidentali
- Infections and infestations
- Infezzjonijiet u infestazzjonijiet
Common: infection, nasopharyngitis
Komuni: infezzjoni, nażo- farinġite
- Respiratory, thoracic and mediastinal disorders
- Mard respiratorju, toraċiku u medjastinali
Common: cough increased
Komuni: żieda fis- sogħla
- Skin and subcutaneous tissue disorders
- Mard tal- ġilda jew tat- tessut ta 'taħt il- ġilda
Common: rash, eczema, pruritus Post-marketing experience: alopecia: in several cases, recovery was observed when Keppra was discontinued.
Komuni: raxx, ekżema, ħakk Esperjenza wara li l- użu tal- prodott fis- suq: alopeċja: f’ ħafna każi, irkupraw meta twaqqaf Keppra
- Blood and lymphatic system disorders
- Mard tad- demm u fis- sistema limfatika
Common: thrombocytopenia Post-marketing experience: leukopenia, neutropenia, pancytopenia (with bone marrow suppression identified in some of the cases)
Esperjenza wara l- użu fis- suq: lukopenja, nutropenja, panċitopenja (b ’ soppressjoni tal- mudullun identifikat f’ xi każi)
Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Keppra overdoses.
Sintomi Wara dożi eċċessivi ta 'Keppra, ġew osservati effetti ta' ħedla, aġitazzjoni, aggressjoni, tnaqqisfil- livell ta 'kuxjenza, livell baxx tar- rifless respiratorju, u koma.
7 After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
X' għandek tagħmel f' każ ta 'doża eċċessiva Wara doża eċċessiva akuta, l- istonku jista' jiġi mbattal permezz ta 'ħasil ta ’ l- istonku jew billi l- pazjent jinġiegħel jirremetti.
There is no specific antidote for levetiracetam.
M' hemmx antidotu speċifiku għal levetiracetam.
Treatment of an overdose will be symptomatic and may include haemodialysis.
Dan jista 'jinvolvi anke id- dijaliżi tad- demm.
The dialyser extraction efficiency is 60% for levetiracetam and 74% for the primary metabolite.
L- effiċjenza ta ’ l- estrazzjoni tad- dijaliżi hija ta '60% għal levetiracetam u ta' 74% għall- prodott ewlieni tal- metaboliżmu.
Pharmacotherapeutic group: antiepileptics, ATC code:
Kategorija farmakoterapewtika: mediċini għall- kontra l- epilessija, Kodiċi ATC:
The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α -ethyl-2-oxo-1- pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
7 Is- sustanza attiva, levetiracetam hija derivattiva ta 'pyrrolidone (S- enantiomer ta ’ α- ethyl- 2- oxo- 1 - pyrrolidine acetamide), u ma jixbahx kimikament lil sustanzi attivi oħrajn li jintużaw kontra l - epilessija.
Mechanism of action
Il- Mod kif jaħdem
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.
Il- mod kif jaħdem levetiracetam għadu jrid jiġi ċċarat, imma jidher li huwa differenti mill- mod kif jaħdmu mediċini oħrajn ta ’ kontra l- epilessija li jintużaw.
In vitro and in vivo experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission.
Esperimenti li saru in vitro u in vivo jgħatu x' nifhmu li levetiracetam ma jibdilx il- karatteristiċi taċ- ċelloli basiċi u n- newrotrasmissjoni normali.
In vitro studies show that levetiracetam affects intraneuronal Ca2+ levels by partial inhibition of N- type Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores.
Studji in vitro juru li levetiracetam jaffetwa livelli ta ’ Ca2+ intranewronali billi jinibixxi parzjalment il - kurrenti ta ’ Ca2+ tat- tip N u billi jnaqqas kemm jintreħa Ca2+ mill- ħażniet intranewronali.
In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β - carbolines.
Huwa wkoll jaqleb parzjalment it- tnaqqis f’ kurrenti gated b ’ GABA u glycine indotti b ’ żingu u ß- carbolines.
Furthermore, levetiracetam has been shown in in vitro studies to bind to a specific site in rodent brain tissue.
Barra minn dan, levetiracetam kien ukoll muri f ’ studji in vitro li jeħel ma post speċifiku fit- tessut tal- moħħ tal- ġrieden u annimali gerriema.
This binding site is the synaptic vesicle protein 2A, believed to be involved in vesicle fusion and neurotransmitter exocytosis.
Dan il- post fejn jeħel huwa l- proteina tal- bużżieqa tas- sinapsi 2A, li hu magħruf li hu involut fil- fużjoni tal- bużżieqa u exositożi ta ’ neurotransmitter.
Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Levetiracetam u sustanzi relatati oħra juru affinita` li jeħlu mal- proteina tal- bużżieqa tas- sinapsi 2A b’ rata li tikkorralata mal- qawwa tal- protezzjoni li jagħtu kontra l- aċċessjonijiet fil- mudell ta ’ l- epilessija awdjoġeniku fil- ġurdien.
This finding suggests that the interaction between levetiracetam and the synaptic vesicle protein 2A seems to contribute to the antiepileptic mechanism of action of the medicinal product.
Dan it- tagħrif jissuġġerixxi li l- interazzjoni bejn levtiracetam u l- proteina tal - bużżieqa tas- sinapsi 2A donnhom jikkontribwixxu għall- mekkaniżmu t’ azzjoni kontra l- epilessija tal - prodott mediċinali.
Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect.
Levetiracetam jgħati protezzjoni kontra aċċessjonijiet kemm tat- tip parzjali kif ukoll tat- tip primarji ġeneralizzati f' firxa wiesgħa ta 'mudelli f' annimali.
The primary metabolite is inactive.
Il- prodott ewlieni tal- metaboliżmu m' huwiex attiv.
In man, an activity in both partial and generalised epilepsy conditions (epileptiform discharge/ photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of levetiracetam.
Il- profil farmakoloġiku wiesa ’ ta ’ levetiracetam ġie ikkomfermat permezz ta ’ l- azzjoni fil- bniedem fuq l- epilessija kemm dik tat- tip parzjali u kemm dik ġeneralizzata (l- attività elettrika tipika fl- epilessija / r- rispons fotoparoksiżimali).
Clinical experience
Esperjenza klinika
Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy:
Terapija miżjuda fit- trattament ta ’ aċċessjonijiet tat- tip parzjali kemm b’ ġeneralizazzjoni sekondarja kif ukoll mingħajr f’ adilti u tfal minn 4 snin b’ epilessija.
In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1000 mg, 2000 mg, or 3000 mg/ day, given in 2 divided doses, with a treatment duration of up to 18 weeks.
F’ adulti, l- effiċjenza ta ’ levetiracetam kiem muri fi 3 studji double- blind ikkontrollati minn plaċebo f dożi ta ’ 1000 mg, 2000mg, jew 3000 mg / kuljum, mogħtija f ’ 2 dożi separati, b’ trattament li dam sa 18 il- ġimgħa.
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 1000, 2000 or 3000 mg levetiracetam respectively and of 12.6% for patients on placebo.
F’ analisi miġbur, il- perċentaġġ ta ’ pazjenti li laħqu tnaqqis ta ’ 50% jew iżjed mill- linja bażi fil- frekwenza fil- ġimgħa ta ’ aċċessjonijiet tat- tip parzjali b’ doża stabli (12/ 14 ġimgħa), kien ta ’ 27. 7%, 31. 6% u 41. 3% għal pazjenti fuq 1000, 2000, jew 3000 mg ta ’ levetiracetam rispettivament u ta ’ 12. 6% għal pazjenti fuq il- plaċebo.
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.
F’ pazjenti pedjatriċi (4 sa 16 il- sena), l- effiċjenza ta ’ levetiracetam kiem muri f ’ studju double- blind ikkontrollat minn plaċebo li inkluda 198 pazjent b’ trattament li dam 14 il- ġimgħa.
In this study, the patients received levetiracetam as a fixed dose of 60 mg/ kg/ day (with twice a day dosing).
F’ dan l- istudju, il - pazjenti ħadu levetiracetam bħala doża fissa ta ’ 60 mg/ kg/ ġurnata (maqsuma f’ darbtejn kuljum).
8 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.
44. 6% ta ’ pazjenti fuq levetiracetam u 19. 6% ta ’ pazjenti fuq il- plaċebo kellhom tnaqqis ta ’ 50% jew iżjed mill- linja bażi fil- frekwenza fil- ġimgħa ta ’ aċċessjonijiet tat- tip parzjali.
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.
Bi trattament li jikompla fit- tul, 11. 4% tal- pazjenti ma kellhomx aċċessjonijiet għal mill- inqas 6 xhur u 7. 2% ma kellhomx aċċessjonijiet għal mill- inqas sena.
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 fit- trattament ta ’ aċċessjonijiet tat- tip parzjali kemm b’ ġeneralizazzjoni sekondarja kif ukoll mingħajr f’ pazjenti minn 16 il - sena li għadhom kif ġew dijanjostikati b ’ epilessija.
Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, non- inferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
L- effikaċja ta ’ levetitacetam bħala monoterapija ġiet stabbilita f’ studju li qabblu b’ mod double- blind, parallel group, non- inferiority ma ’ carbamazepine f ’ għamla li jintreħa b ’ mod kontrollat (CR) f’ 576 pazjenti ta ’ 16 il- sena jew iżjed li għadhom kif ġew dijanjostikati b ’ epilessija.
The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Il- pazjenti kellhom jippreżentaw ruħhom b’ aċċessjonijiet parzjali mhux provokati jew b’ aċċessjonijiet ġeneralizzati tat- tip tonic- clonic biss.
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.
8 carbamazepine CR 400- 1200 mg/ ġurnata jew levetiracetam 1000- 3000 mg/ ġurnata, b’ trattament li dam sa 121 ġimgħa skond kemm kien ir- rispons.
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).
Kien hemm 73. 0% tal- pazjenti li ġew trattati b ’ levetiracetam u 72. 8% ta ’ pazjenti li ġew trattati b ’ carbamazepine- CR li damu sitt xhur mingħajr aċċessjonijiet; id- differenza assoluta aġġustata bejn it - trattamenti kienet ta ’ 0. 2% (95% CI: - 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).
Iżjed minn nofs il- pazjenti baqaw mingħajr aċċessjonijet għal 12 il- xahar (56. 6% u 58. 5% tal- pazjenti fuq levetiracetam u fuq carbamazepine CR rispettivament).
In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of 69).
Fi studju li jirrifletti l- prattika klinika, l- mediċini ta ’ kontra l- epilessija li ingħataw fl- istess ħin setgħu jiġu mwaqqfa f’ numru limitat ta ’ pazjenti li rrispondew għal terapija miżjuda b ’ levetiracetam (36 pazjent minn 69).
Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Terapija miżjuda fit- trattament ta ’ aċċessjonijiet mijokloniċi f’ adulti u addoloxxenti min 12 il- sena b’ epilessija mijoklonika li tibda fiż- żgħożija.
Levetiracetam efficacy was established in a double-blind, placebo-controlled study of 16 weeks duration, in patients 12 years of age and older suffering from idiopathic generalized epilepsy with myoclonic seizures in different syndromes.
L- effiċjenza ta ’ levetiracetam kien muri f ’ studju double- blind ikkontrollati minn plaċebo f i studju li dam 16 il- ġimgħa, f’ pazjenti ta ’ 12 il- sena jew iżjed li jbagħtu minn epilessija ġeneralizzata idjopatika b’ aċċessjonijiet mijokloniċi b’ sindromi differenti.
The majority of patients presented with juvenile myoclonic epilepsy.
Il- maġġoranza ta ’ pazjenti ppreżentaw b ’ epilessija tat- tip mijoklonika li tibda fiż- żgħożija.
In this study, levetiracetam, dose was 3000 mg/ day given in 2 divided doses.
F’ dan l- istudju, levetiracetam ingħata f’ doza ta ’ 3000 mg/ ġurnata f’ żewġt dożi separati.
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.
58. 3% tal- pazjenti trattati b ’ levetiracetam u 23. 3% tal- pazjenti fuq plaċebo kellhom mill- inqas 50% ta ’ tnaqqis fil- ġranet b’ aċċessjonijiet mijokloniċi fil- ġimgħa.
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.
B’ trattament li jitkompla fit- tul, 28. 6% tal- pazjenti ma kellhomx aċċessjonjiet mijokloniċi għal mill- inqas 6 xhur u 21. 0% ma kellhomx aċċessjonjiet mijokloniċi għal mill- inqas sena.
Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Terapija miżjuda fit- trattament ta ’ aċċessjonijiet ġeneraliżżati primarji tat- tip tonic- clonic f ’ adulti u addoloxxenti minn 12 il- sena b’ epilessija ġeneralizzata idjopatika.
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).
L- effikaċja ta ’ levetiracetam kienet stabbilita f’ studju double- blind, ikkontrollat minn plaċebo ta ’ 24 ġimgħa, li inkludiet adulti, addoloxxenti u numru limitat ta ’ tfal b ’ epilessija tat- tip ġeneralizzata idjopatika b’ aċċessjonijiet ġeneralizzati primarji tat- tip tonic- clonic (PGTC) f’ sindromi (epilessija mijoklonika li tibda fiż- żgħożija, epilessija tat- tip absence li tibda fiż- żgħożija, epilessija tat- tip absence fit- tfal, jew epilessija b’ aċċessjonijiet Grand Mal meta jqumu).
In this study, levetiracetam dose was 3000 mg/ day for adults and adolescents or 60 mg/ kg/ day for children, given in 2 divided doses.
F’ dan l- istudju, id- doża ta ’ levetiracetam kienet ta ’ 3000 mg/ ġurnata fl- adulti u l- addoloxxenti jew 60 mg/ kg/ ġurnata fit- tfal, li ingħataw f’ 2 dożi separati.
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.
72. 2% ta ’ pazjenti fuq levetiracetam u 45. 2% tal- pazjenti fuq plaċebo kellhom tnaqqis ta ’ 50% jew aktar fil- frekwenza ta ’ aċċessjonijiet PGTC fil- ġimgħa.
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.
B’ trattament li jitkompla fit- tul, 47. 4% tal - pazjenti ma kellhomx aċċessjonijiet tat- tip tonic- clonic għal mill- inqas 6 xhur u 31. 5% ma kellhomx aċċessjonijiet tat- tip tonic- clonic għal mill- inqas sena.
Levetiracetam is a highly soluble and permeable compound.
Levetiracetam għandu solubilità għolja u huwa permejabbli.
The pharmacokinetic profile is linear with low intra- and inter-subject variability.
Il- profil farmakokinetiku huwa linejari bi ftit varjazzjoni bejn pazjenti differenti u fl- istess pazjenti infishom.
There is no modification of the clearance after repeated
M' hemm ebda differenza fir- rata li biha jitneħħa mill- ġisem wara li jingħata ripetutament.
There is no evidence for any relevant gender, race or circadian variability.
Xejn ma juri li hemm xi varjabilità rilevanti f' pazjenti ta 'sess, razza jew ritmu ċirkadjan differenti.
The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy.
Il- profil farmakokinetiku f' voluntiera f' saħħithom jixbah lil dak f' pazjenti bl- epilessija.
Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg/ kg bodyweight.
Minħabba li jiġi assorbit kompletament u linejarment, il- livell fil- plażma jista 'jiġi kkalkulat minn qabel mid- doża ta ’ levetiracetam meta meħudha bħala mg / kg piż tal- pazjent.
Therefore there is no need for plasma level monitoring of levetiracetam.
M' hemmx għalfejn jiġi eżaminat il- livell ta 'levetiracetam fil- plażma.
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).
Intwera korrelazzjoni sinifikanti bejn il- konċentrazzjonijiet fil- bżieq u fil- plażma fl- adulti u fit- tfal (proporzjon ta ’ konċentrazzjonijiet fil- bżieq / plażma kienu f’ medda ta ’ bejn 1 sa 1. 7 b ’ pillola orali u wara 4 siegħat wara d- doża b’ soluzzjoni orali).
Adults and adolescents
Adulti u addoloxxenti
Absorption
9 Assorbiment
Levetiracetam is rapidly absorbed after oral administration.
Levetiracetam huwa assorbit malajr wara li jittieħed mill- ħalq.
Oral absolute bioavailability is close to 100%.
Wara li jittieħed mill- ħalq jinfirex kwazi kollu (100%) fil- gisem.
Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing.
Jintlaħqu il- konċentrazzjonijiet massimi (Cmax) 1. 3 sigħat wara li tittieħed id- doża.
Steady-state is achieved after two days of a twice daily administration schedule.
Il- livell fiss jintlaħaq wara jumejn fejn jittieħdu żewġ dożi kuljum.
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.
Il- livelli massimi (Cmax) huma ssoltu 31μg/ ml wara doża waħda ta '1, 000 mg u 43 μg/ ml wara doża ripetuta ta' 1, 000 mg darbtejn kuljum.
The extent of absorption is dose-independent and is not altered by food.
Kemm id- doża kif ukoll l- ikel ma għandhomx effett fuq kemm jiġi assorbit.
No tissue distribution data are available in humans.
M' hemmx tagħrif fuq id- distribuzzjoni fit- tessut tal- bniedem.