qanastek/EMEA-V3 huggingface dataset:
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 adulti u tfal minn 4 snin b’ epilessija. • fit- trattament ta ’ aċċessjonijiet tat- tip mijoklonika adulti u addoloxxenti minn 12 snin b’ epilessija tat- tip Mijoklonika li tibda fiż- zgħożija • Fit- trattament ta ’ aċċessjonijiet primarji u ġeneralizzati tat- tip tonic- clonic f’ adulti u addoloxxenti minn 12 il- sena b’ Epilessija Ġeneralizzata Idjopatika.
Keppra concentrate is an alternative for patients when oral administration is temporarily not feasible.
Il- konċentrat Keppra huwa alternattiva għal pazjenti li temporanjament ma ’ jistgħux jieħdu mediċina mill- ħalq.
Keppra therapy can be initiated with either intravenous or oral administration.
It- terapija b’ Keppra tista ’ tinbeda jew billi tingħata ġol- vini jew bil- ħalq.
Conversion to or from oral to intravenous administration can be done directly without titration.
It- tibdil minn użu minn ġol - ħalq għal minn ġol- vina jew viċi versa jista ’ jsir direttament mingħajr titrazzjoni.
The total daily dose and frequency of administration should be maintained.
Id- doża totali ta ’ kuljum u l- freqwenza ta ’ kif jittieħed għandhom jinżammu.
Keppra concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Il- konċentrat Keppra huwa għal- użu ġol - vina biss u d- doża rikkmandata għandha tiġi dilwita f ’ mill- inqas 100ml ta ’ dilwent kompattibli u għandu jingħata minn ġol- vina bħala infużjoni ġol- vina ta ’ 15 il- minuta.
There is no experience with administration of intravenous levetiracetam for longer period than 4 days.
M’ hemmx esperjenza bl- użu ta ’ levetiracetam minn ġol- vina għal perjodi itwal minn 4 ijiem.
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 ġimagħtejn.
62 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.
62 Id- doża tal- bidu hija ta '500 mg darbtejn kuljum.
A Keppra concentrate vial contains 500 mg levetiracetam in 5 ml (corresponding to 100 mg/ ml).
Vjala tal- konċentrat Keppra fiha 500 mg levetiracetam ġo 5 ml (jikkorrespondi għal 100 mg/ ml).
63 CLcr (ml/ min) CLcr (ml/ min/ 1.73 m2) = ---------------------------- x 1.73 BSA subject (m2)
63 CLcr (ml/ min) CLcr (ml/ min/ 1. 73 m2) = ---------------------------- x 1. 73 BSA pazjent (m2)
Dosing adjustment for adult patients with impaired renal function
Regolar tad- doża f' pazjenti adulti bi ħsara fil- kliewi
> 80 50-79 30-49 < 30 -
500 sa > 80
500 500 250 250 500
1, 500 mg darbtejn kuljum
to 1,500 mg twice daily to 1,000 mg twice daily to 750 mg twice daily to 500 mg twice daily to 1,000 mg once daily (2)
500 sa 50- 79
A meta-analysis of randomized placebo-controlled
Meta- analiżi ta ’ provi randomized u kkontrollati mill- plaċebo ta ’ mediċini ta ’ kontra l- epilessija juri żieda żgħira fil- ħsibijiet u mġieba suwiċidali.
Therefore patients should be monitored for signs of depression and/ or suicidal ideation and behaviours and appropriate treatment should be considered.
64 Għalhekk il- pazjenti għandhom jiġu ċċekkjati għal sinjali ta ’ depressjoni u/ jew ħsibijiet u mġieba suwiċidali u għandu jitqies trattament xieraq.
This medicinal product contains 0.313 mmol (or 7.196 mg) of sodium per vial.
Din il- mediċina fiha 0. 313 mmol (jew 7. 196 mg) ta ’ sodju f’ kull vjala.
To be taken into consideration by patients on a controlled sodium diet.
Dan għandu jitqies minn pazjenti fuq dieta nieqsa mis- sodju.
Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinyl- estradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
Levetiracetam 1, 000 mg me kellu ebda effett fuq il- farmakokinetika ta ’ kontraċettivi orali (ethinyl - estradiol u levonorgestrel); parametric endokrinarji (luteinizing hormone u progesterone). ma kienux mibdulin.
Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified.
Levetiracetam 2, 000 mg kuljum ma kellux effett fuq il- farmakokinetika ta ’ digoxin u warfarin; ma kienux mibdulin il- prothrombin times.
Co-administration with digoxin, oral contraceptives and warfarin did not influence the pharmacokinetics of levetiracetam.
Ma kien hemmx tibdil fil - farmakokinetika ta ’ levetiracetam meta ittieħed flimkien ma ’ digoxin, kontraċettivi orali u warfarin.
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- għar u għalhekk tista ’ tkun ta 'ħsara għall- omm u l- fetu.
65 4.7 Effects on ability to drive and use machines
65 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Undesirable effects that resulted from Keppra intravenous use are similar to those associated with Keppra oral use.
Effetii mhux mixtieqa li rrizultaw minn Keppra b’ użu ġol- vini kienu simili minn dawk assoċjati ma ’ l - użu ta ’ Keppra mill- ħalq.
The most frequently reported adverse reactions were dizziness, somnolence, headache and postural dizziness.
L- izjed effetti mhux mixtieqa li gew irraportati kienu sturdament, nagħas, uġigħ ta ’ ras u sturdament meta tqum minn mindud.
Since there was limited exposure for Keppra intravenous use and since oral and intravenous formulations are bioequivalent, the safety information of Keppra intravenous will rely on Keppra oral use.
Għaliex kien hemm espożizzjoni limitata ta ’ Keppra b’ użu minn ġol- vina u ukoll għaliex l- għamla li tittieħed minn ġol- vina u dik orali huma bijoekwivalenti, it- tagħrif ta ’ sigurta` ta ’ Keppra li jittieħed minn ġol- vina huwa bbażat fuq dak ta ’ Keppra orali.
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.
Huma maqsumin skond l- organu jew sistema u skond il - frekwenza.
For clinical trials, the frequency is defined as follows: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon:
(> 1/ 100, ≤1/ 10); mhux komuni:
(≥ 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.
66
66 Komuni ħafna: astenja/ għajja.
Common: amnesia, ataxia, convulsion, dizziness, headache, hyperkinesia, tremor, balance disorder, disturbance in attention, memory impairment Post-marketing experience: paraesthesia
Esperjenza wara li l- użu tal- prodott fis- suq: para- astenja
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
Post-marketing experience: pancreatitis
Komuni: uġigħ fl- addomenu, dijarrea, indiġestjoni, dardir, rimettar Esperjenza wara li l- użu tal- prodott fis- suq: pankreatite
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
67 4.9 Overdose
67 Wara dożi eċċessivi ta 'Keppra, ġew osservati effetti ta' ħedla, aġitazzjoni, aggressjoni, tnaqqisfil- livell ta 'kuxjenza, livell baxx tar- rifless respiratorju, u koma.
Management of overdose
X' għandek tagħmel f' każ ta 'doża eċċessiva
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.
Is- sustanza attiva, levetiracetam hija derivattiva ta 'pyrrolidone (S- enantiomer ta ’ α- ethyl- 2- oxo- 1 - pyrrolidine acetamide), u ma jixbaħx kimikament lil sustanzi attivi oħrajn li jintużaw kontra l - epilessija.
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.
Levetiracetam and related analogues 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.
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 68 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 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.
68 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.
69 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.
The pharmacokinetic profile has been characterized following oral administration.
69 Il- profil farmakokinetiku ġie muri wara l- użu mill- ħalq.
A single dose of 1500 mg levetiracetam diluted in 100 ml of a compatible diluent and infused intravenously over 15 minutes is bioequivalent to 1500 mg levetiracetam oral intake, given as three 500 mg tablets.
Doża waħda ta ’ 1500 mg ta ’ levetiracetam miżjud b ’ 100 ml ta ’ dilwent kompattibli u li jittieħed b’ infużjoni minn ġol- vina f ’ 15 il- minuta hija bijoekwivalenti għal 1500 mg ta ’ levetiracetam li tittieħed mill- ħalq, u li tingħata bħala tlett pilloli ta ’ 500mg.
The intravenous administration of doses up to 4000 mg diluted in 100 ml of 0.9% sodium chloride infused over 15 minutes and doses up to 2500 mg diluted in 100 ml of 0.9% sodium chloride infused over 5 minutes was evaluated.
Kienu evalwati, it- teħid minn ġol- vina ta ’ dożi sa 4000 mg miżjudin b ’ 100 ml ta ’ 0. 9% sodium chloride b’ infużjoni f ’ 15 il- minuta u dożi sa 2500 mg miżjudin b ’ 100 ml ta ’ 0. 9% sodium chloride b’ infużjoni f ’ 5 minuti.
The pharmacokinetic and safety profiles did not identify any safety concerns.
Il- profil farmakokinetiku u ta ’ sigurta` ma wrew ebda problemi ta ’ sigurta`.
Levetiracetam is a highly soluble and permeable compound.
Levetiracetam għandu solubilità u permejabilta` għolja.
The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1500 mg intravenous infusion for 4 days with b. i. d dosing.
Il- profil farmakokinetiku li huwa indipendenti mill- ħin kien ikkonfermat wkoll wara infużjoni minn ġol- vina ta ’ 1500 mg għal 4 ijiem b ’ doża b. i. d.
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.
Peak plasma concentration (Cmax) observed in 17 subjects following a single intravenous dose of 1500 mg infused over 15 minutes was 51 ± 19 µg/ mL (arithmetic average ± standard deviation).
L- ogħla konċentrazzjoni fil- plażma (C max) osservati f ’ 17 il- pazjent wara doża waħda ta ’ 1500 mg li ittieħded b’ infużjoni minn ġol- vina f ’ 15 il- minuta kienet ta ’ 51 ± 19 µg/ ml (il- medja aritmatika ± standard deviation).
The in vitro data and in
Levitiracetam ikkawża induzzjoni ħafifa ta ’ CYP2B6 u CYP3A4.
Therefore, the interaction of Keppra with other substances, or vice versa, is unlikely.
Tagħrif in vitro u tagħrif dwar l- interazzjoni in vivo fuq kontraċettivi orali, digoxin u warfarina jindika li mhux mistenni li jkun hemm induzzjoni sinifikanti ta ’ l- enżimi. Għalhekk hija improbabli li Keppra ma jaqbilx ma 'sustanzi oħra b ’ mod klinikament sinifikanti, u viċe versa.
Elimination
70 Eliminazzjoni
The pharmacokinetics in paediatric patients has not been investigated after intravenous administration.
Il- farmakokinetika f ’ pazjenti pedjatriċi ma kienx investigat wara l- użu minn ġol- vina.
However, based on the pharmacokinetic characteristics of levetiracetam, the pharmacokinetics in adults after intravenous administration and the pharmacokinetics in children after oral administration, the exposure (AUC) of levetiracetam is expected to be similar in paediatric patients aged 4 to 12 years after intravenous and oral administration.
Imma bbażat fuq il- karatteristiċi farmakokinetiċi ta ’ levetiracetam, il- farmakokinetika fl- adulti wara li jingħata minn ġol- vina u l- farmakokinetika fit- tfal wara amministrazzjoni orali, l- esponiment (AUC) ta ’ levetiracetam huwa mistenni li jkun l- istess fil- pażjenti pedjatriċi ta ’ eta` minn 4 sa 12 snin wara li jittieħed minn ġol- vina u minn ġol- ħalq.
Following single oral dose administration (20 mg/ kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
Wara li ngħatat doża orali waħda li tammonta għal 20 mg/ kg lil tfal bl- epilessija (6 sa 12 il- sena), il - half life ta ’ levetiracetam kienet ta ’ 6. 0 sigħat.
71 In subjects with mild and moderate hepatic impairment, there was no relevant modification of the clearance of levetiracetam.
M' hemmx differenzi fir- rata ta 'tneħħija ta' levetiracetam f 'pazjenti b' mard hafif u moderat tal- fwied.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenicity.
71 Tagħrif mhux fuq l- użu kliniku meħud minn studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku fuq il- ġeni, u riskju ta ’ kanċer, ma ’ turi l- ebda periklu speċjali għall- bnedmin.
Sodium acetate Glacial acetic acid Sodium chloride Water for injection
Sodium acetate Glacial acetic acid Sodium chloride Ilma għall- injezzjoni
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6. 2 Inkompatibiltajiet
6.3 Shelf life Finished product:
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
From a microbiological point of view, the product should be used immediately after dilution.
Mill- lat mikrobijoloġoku, il- prodott għandu jintuża immedjatament wara li jiġi jilwit.
If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Dan m’ għandux ikun iżjed minn 24 siegħa f ’ 2 sa 8ºC, sakemm ma ġiex dilwit f’ post b ’ kundizzjonijiet mhux settiċi ikkontrollati u kkonfermati.
No special precautions for storage.
M’ hemmx struzzjonijiet dwar ħażna speċjali.
For storage conditions of the diluted medicinal product, see section 6.3.
Għal sruzzjonijiet speċjali dwar il- ħażna tal- prodott mediċinali dilwit ara sezzjoni 6. 3.
Keppra concentrate is packed in glass vials (type I) with Teflon faced stoppers and sealed with an aluminium/ polypropylene flip off cap.
Il- konċentrat Keppra issibu ppakkjat fi vjali tal- ħġieġ (tip I) b' għatu b’ wiċċ tat- Teflon u ssiġillati b’ tap li jinqala tal- aluminjum / polypropylene.
The vials are placed into cartons of 10 vials.
Il- vjali issibhom f’ kaxxi ta ’ 10 vjali.
Each vial contains 5 ml of concentrate.
Kull vjali fiha 5 ml ta ’ konċentrat.
72 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
One vial of Keppra concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ ml).
Vjala waħda ta ’ Keppra fiha 500 mg ta ’ levetiracetam (5 ml ta ’ konċentrat ta ’ 100 mg/ ml).
See Table 1 for the recommended preparation and administration of Keppra concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg, or 3000 mg in two divided doses.
Ara iskeda 1 għall- preparazzjoni rikkmandata kif ukoll il- metodu rikmandat ta ’ kif jingħata l - konċentrat Keppra biex tilħaq doża totali ta ’ 500mg, 1000 mg, 2000 mg, jew 3000 mg kuljum, f’ żewġt dożi separati.
Table 1.
Skeda 1.
Preparation and administration of Keppra concentrate
L- metodu ta ’ preparazzjoni u ta ’ kif jingħata rikkmandat bil- konċentrat ta ’ Keppra
Withdrawal Volume
Volum li jinġibed
Volume of Diluent
ta ’ dilwent
Infusion Time
infużjoni
Frequency of administration
2. 5 ml (nofs vjala ta ’ 5 ml)
Total Daily Dose
500 mg/ ġurnata
2.5 ml (half 5 ml vial) 5 ml (one 5 ml vial) 10 ml (two 5 ml vials) 15 ml (three 5 ml vials)
5 ml (vjala waħda ta ’ 5 ml)
15 minutes 15 minutes 15 minutes 15 minutes
15 minuti
Twice daily Twice daily Twice daily Twice daily
10 ml (żewġt vjali ta ’ 5 ml) 100 ml
500 mg/ day 1000 mg/ day 2000 mg/ day 3000 mg/ day
3000 mg / ġurnata
This medicinal product is for single use only, any unused solution should be discarded.
Xi soluzzjoni li ma tintużax trid tintrema.
Keppra concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15- 25°C.
Il- konċentrat Keppra instab li kien fiżikament kompattibli u kimikament stabli meta mħallat ma ’ dawn id- dilwenti għal mill- inqas 24 siegħa u meta maħżuna f ’ basktijiet tal- PVC f’ temperatura ta ’ l- ambjent kontrollata ta ’ 15- 25°C.
Diluents: • Sodium chloride (0.9%) injection • Lactated Ringer’ s injection • Dextrose 5% injection
Dilwenti: • injezzjoni ta ’ sodium chloride (0. 9%) • injezzjoni ta ’ Lactated Ringer • injezzjoni ta ’ Dextrose 5%
Product with particulate matter or discoloration should not be used.
Prodott li fih il- frak jew li tilef il- kulur m’ għandux jintuża.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT B.
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturers responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott.
UCB Pharma SA Chemin du Foriest B-1420 Braine l’ Alleud Belgium
UCB Pharma SA Chemin du Foriest B- 1420 Braine l’ Alleud Belġju
Via Praglia, 15 I-10044 Pianezza Italy
Via Praglia, 15 I- 10044 Pianezza Italja
Oral Solution
Soluzzjoni Orali
NextPharma SAS 17, Route de Meulan F-78520 Limay France
NextPharma SAS 17, Route de Meulan F- 78520 Limay Franza
The MAH will submit PSURs on an annual basis until the next renewal.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq ser jagħti PSURs kull sena sa tiġdid li jmiss.
Subsequent PSURs will be submitted in accordance to the legislation, unless otherwise specified.
Il- PSURs ta ’ wara ser jingħataw skond il- liġijiet, sakemm ma jiġiex avżat mod ieħor.
BOX of 20, 30, 50, 60, 100, 200
KAXXA ta '20, 30, 50, 60, 100, 200
Keppra 250 mg film-coated tablets Levetiracetam
Keppra 250 mg pilloli miksija b 'rita Levetiracetam
Each film-coated tablet contains 250 mg levetiracetam.
Kull pillola miksija b' rita fiha 250 mg ta 'levetiracetam
20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 200 film-coated tablets
20 pillola miksija b' rita 30 pillola miksija b' rita 50 pillola miksija b' rita 60 pillola miksija b' rita 100 pillola miksija b' rita 200 pillola miksija b' rita
Exp:
JIS:
{MM-YYYY}
[XX/ SSSS]
Allée de la Recherche 60 B-1070 Bruxelles BELGIUM
Sid tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq UCB Pharma SA Allée de la Recherche 60 B- 1070 Bruxelles Belġju
EU/ 1/ 00/ 146/ 001 20 tablets EU/ 1/ 00/ 146/ 002 30 tablets EU/ 1/ 00/ 146/ 003 50 tablets EU/ 1/ 00/ 146/ 004 60 tablets EU/ 1/ 00/ 146/ 005 100 tablets EU/ 1/ 00/ 146/ 029 200 tablets
EU/ 1/ 00/ 146/ 001 20 pillola EU/ 1/ 00/ 146/ 002 30 pillola EU/ 1/ 00/ 146/ 003 50 pillola EU/ 1/ 00/ 146/ 004 60 pillola EU/ 1/ 00/ 146/ 005 100 pillola EU/ 1/ 00/ 146/ 029 200 pillola
{number}
[numru]
79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate packaging containing 100 tablets for box of 200 tablets
Pakkett intermedjarju li fih 100 pillola għal kaxxa ta ’ 200 pillola
Film-coated tablets
pilloli miksija b' rita
81 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
81 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
{MM-YYYY}
JIS: {XX/ SSSS}
82 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
82 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Box of 10, 20, 30, 50, 60, 100, 120, 200
KAXXA ta '10, 20, 30, 50, 60, 100, 120, 200
Keppra 500 mg film-coated tablets Levetiracetam
Keppra 500 mg pilloli miksija b 'rita Levetiracetam
Each film-coated tablet contains 500 mg levetiracetam.
Kull pillola miksija b' rita fiha 500 mg ta 'levetiracetam
10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 120 film-coated tablets 200 film-coated tablets
10 pillola miksija b' rita 20 pillola miksija b' rita 30 pillola miksija b' rita 50 pillola miksija b' rita 60 pillola miksija b' rita 100 pillola miksija b' rita 120 pillola miksija b' rita 200 pillola miksija b' rita
EU/ 1/ 00/ 146/ 006 10 tablets EU/ 1/ 00/ 146/ 007 20 tablets EU/ 1/ 00/ 146/ 008 30 tablets EU/ 1/ 00/ 146/ 009 50 tablets EU/ 1/ 00/ 146/ 010 60 tablets EU/ 1/ 00/ 146/ 011 100 tablets EU/ 1/ 00/ 146/ 012 120 tablets EU/ 1/ 00/ 146/ 013 200 tablets
EU/ 1/ 00/ 146/ 006 10 pillola EU/ 1/ 00/ 146/ 007 20 pillola EU/ 1/ 00/ 146/ 008 30 pillola EU/ 1/ 00/ 146/ 009 50 pillola EU/ 1/ 00/ 146/ 010 60 pillola EU/ 1/ 00/ 146/ 011 100 pillola EU/ 1/ 00/ 146/ 012 120 pillola EU/ 1/ 00/ 146/ 013 200 pillola
84 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate packaging containing 100 tablets for box of 200 tablets
Pakkett intermedjarju li fih 100 pillola għal kaxxa ta ’ 200 pillola
86 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
86 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
87 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
87 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Box of 20, 30, 50, 60, 80, 100, 200
KAXXA ta '20, 30, 50, 60, 80, 100, 200
Keppra 750 mg film-coated tablets Levetiracetam
Keppra 750 mg pilloli miksija b 'rita Levetiracetam
Each film-coated tablet contains 750 mg levetiracetam.
Kull pillola miksija b' rita fiha 750 mg ta 'levetiracetam
Product excipients include E 110.
Wieħed mis- sustanzi mhux attivi huwa E 110.
20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 80 film-coated tablets 100 film-coated tablets 200 film-coated tablets
20 pillola miksija b' rita 30 pillola miksija b' rita 50 pillola miksija b' rita 60 pillola miksija b' rita 80 pillola miksija b’ rita 100 pillola miksija b' rita 200 pillola miksija b' rita
EU/ 1/ 00/ 146/ 014 20 tablets EU/ 1/ 00/ 146/ 015 30 tablets EU/ 1/ 00/ 146/ 016 50 tablets EU/ 1/ 00/ 146/ 017 60 tablets EU/ 1/ 00/ 146/ 018 80 tablets EU/ 1/ 00/ 146/ 019 100 tablets EU/ 1/ 00/ 146/ 028 200 tablets
EU/ 1/ 00/ 146/ 014 20 pillola EU/ 1/ 00/ 146/ 015 30 pillola EU/ 1/ 00/ 146/ 016 50 pillola EU/ 1/ 00/ 146/ 017 60 pillola EU/ 1/ 00/ 146/ 018 80 pillola EU/ 1/ 00/ 146/ 019 100 pillola EU/ 1/ 00/ 146/ 028 200 pillola
Intermediate packaging containing 100 tablets for box of 200 tablets
Pakkett intermedjarju li fih 100 pillola għal kaxxa ta ’ 200 pillola
91 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
91 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
92 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
92 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Box of 10, 20, 30, 50, 60, 100, 200
KAXXA ta '10, 20, 30, 50, 60, 100, 200
Keppra 1000 mg film-coated tablets Levetiracetam
Keppra 1000 mg pilloli miksija b 'rita Levetiracetam
Each film-coated tablet contains 1,000 mg levetiracetam.
Kull pillola miksija b' rita fiha 1000 mg ta 'levetiracetam
10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 200 film-coated tablets
10 pillola miksija b’ rita 20 pillola miksija b' rita 30 pillola miksija b' rita 50 pillola miksija b' rita 60 pillola miksija b' rita 100 pillola miksija b' rita 200 pillola miksija b' rita
EU/ 1/ 00/ 146/ 020 10 tablets EU/ 1/ 00/ 146/ 021 20 tablets EU/ 1/ 00/ 146/ 022 30 tablets EU/ 1/ 00/ 146/ 023 50 tablets EU/ 1/ 00/ 146/ 024 60 tablets EU/ 1/ 00/ 146/ 025 100 tablets EU/ 1/ 00/ 146/ 026 200 tablets
EU/ 1/ 00/ 146/ 020 10 pillola EU/ 1/ 00/ 146/ 021 20 pillola EU/ 1/ 00/ 146/ 022 30 pillola EU/ 1/ 00/ 146/ 023 50 pillola EU/ 1/ 00/ 146/ 024 60 pillola EU/ 1/ 00/ 146/ 025 100 pillola EU/ 1/ 00/ 146/ 026 200 pillola
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
94 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each film-coated tablet contains 1,000 mg levetiracetam.
Kull pillola miksija b' rita fiha 1, 000 mg ta 'levetiracetam
96 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
96 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
97 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE of 300 ml
Flixkun ta ’ 300 ml
Keppra 100 mg/ ml oral solution Levetiracetam
Keppra 100 mg/ ml soluzzjoni orali Levetiracetam
Each ml contains 100 mg levetiracetam.
Kull ml fih 100 mg ta 'levetiracetam
Other ingredients include E216, E218 and maltitol.
Is- sustanzi mhux attivi jinkludu E216, E218 u maltitol.
Bottle of 300 ml.
Flixkun ta ’ 300 ml.
{MM-YYYY} Do not use after 2 months of first opening the bottle
[XX/ SSSS] Tużax wara xagħrejn wara li l- ewwel tiftaħ il- flixkun.
99 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
99 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Box of 10 vials
KAXXA ta '10 vjali
Keppra 100 mg/ ml concentrate for solution for infusion Levetiracetam
Keppra 100 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Levetiracetam
One vial contains 500 mg/ 5 ml levetiracetam.
Vjala waħda fiha 500 mg / 5 ml levitiracetam.
Other ingredients include sodium acetate, glacial acetic acid, sodium chloride, water for injection
Sustanzi mhux attivi jinkludu sodium acetate, glacial acetic acid, sodiun chloride, ilma għall- injezzjoni
10 vials of concentrate for solution for infusion
10 vjali ta ’ konċentrat għal soluzzjoni għall- infużjoni
Intravenous use
Jittieħed minn ġol- vina
{MM-YYYY} Use immediatly after dilution.
[XX/ SSSS] Uża immedjatament wara li jiġi dilwit.
101 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
101 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
vial of 5 ml
vjala ta ’ 5 ml
Keppra 100 mg/ ml concentrate for solution for infusion Levetiracetam Intravenous administration
Keppra 100 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Levetiracetam Użu minn ġol- vina
103 PACKAGE LEAFLET:
103 FULJETT TA ’ TAGĦRIF:
Levetiracetam
Keppra 250mg pilloli miksija b’ rita Levetiracetam
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew spiżjar tiegħek.
Do not pass it on to others.
oħra.
What Keppra is and what it is used for 2.
X’ inhu Keppra u għalxiex jintuża 2.
Before you take Keppra 3.
Qabel ma ’ tieħu Keppra 3.
How to take Keppra 4.
Kif għandek tieħu Keppra 4.
How to store Keppra 6.
Kif taħżen Keppra 6.
WHAT KEPPRA IS AND WHAT IT IS USED FOR
X’ INHU KEPPRA U GĦALXIEX JINTUŻA
Keppra 250 mg film-coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Keppra 250 mg pilloli miksija b 'rita hija mediċina għal kontra l- epilessija (użata biex tittratta l - aċċessjonijiet f- epilessija).
Keppra is used alone in the treatment of partial seizures in patients from 16 years of age.
Keppra huwa wżat waħdu fit- trattament ta 'aċċessjonijiet tat- tip parzjali f' pazjenti minn 16 il- sena.
Keppra is used in patients who are already taking another antiepileptic medicine • in the treatment of partial seizures in adults and children from 4 years age • in the treatment of myoclonic seizures in patients 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
Keppra huwa wżat f ’ pazjenti li diga ’ ikunu qiegħdin jieħdu mediċini oħra għal kontra l- epilessija • fit- trattament ta 'aċċessjonijiet tat- tip parzjali f ’ adulti u tfal minn 4 snin. • fit- trattament ta ’ aċċessjonijiet tat- tip mijokloniċi f ’ pazjenti 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
BEFORE YOU TAKE KEPPRA
QABEL MA ’ TIEĦU KEPPRA
Keppra is used in adults and children over 4 years of age.
Keppra tintuża f' adulti u tfal ta '' l fuq minn 4 snin.
It is not recommended for children less than 4 years old.
M' huwiex irrikkmandat għall- użu fit- tfal ta 'taħt l - 4 snin.
Do not take Keppra: • if you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of Keppra.
Tieħux Keppra • jekk tbati minn allerġija (sensittività eċċessiva) għal levetiracetam jew sustanzi oħra ta ’ Keppra.
Take special care with Keppra: • if you suffer from kidney problems, follow your doctor’ s instructions.
Oqgħod attent ħafna b’ Keppra • jekk int tbati minn problemi fil- kliewi, oqgħod fuq li jgħidlek it- tabib.
He/ she may decide if your dose should be adjusted. • No impact on growth and puberty were noticed in children who have taken Keppra.
Dan/ din jista 'jiddeċiedi li jbidillek id- doża. • Ma deherx li kien hemm xi effett fuq il- kobor u l- puberta` fit- tfal li ħadu Keppra.
However, there is limited experience on long term effects in children. • If you notice an increase in seizure severity (e. g. increased number), please contact your doctor. • A small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming or killing themselves.
Madanakollu, hemm esperjenza limitata fl- effetti fit- tul fuq it- tfal. • Jekk tinnota xi żieda fis- severita` ta ’ l- aċċessjonijiet (ez. żieda fin - numru), jekk jogħġbok, għarraf lit- tabib tiegħek. • Numru żgħir ta ’ nies fuq trattament b’ mediċini ta ’ kontra l- epilessija bħal Keppra kellhom ħsibijiet li jweġġgħu jew joqtlu lilhom infushom.
If you have any symptoms of depression and/ or suicidal ideation, please contact your doctor.
Jekk għandek xi sintomi ta ’ depressjoni u/ jew ħsibijiet ta ’ suwiċidju, jekk jogħġbok għarraf lit- tabib tiegħek.
104 Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
104 Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
You may take Keppra with or without food.
Meta tieħu Keppra ma ’ l- ikel u max- xorb Tista 'tieħu Keppra kemm fuq l- ikel u kemm fuq stonku vojt.
As a safety precaution, do not take Keppra with alcohol.
Bħala prekawzjoni għas- sigurta`, tixrobx alkoħol meta tieħu Keppra.
Ask your doctor or pharmacist for advice before taking any medicine.
Tqala u t- treddigħ Itlob għall- parir tat- tabib jew spiżjar tiegħek qabel tieħu xi mediċina.
If you are pregnant or if you think you may be pregnant, please inform your doctor.
Jekk jogħġbok għarraf lit- tabib tiegħek jekk inti tqila jew taħseb li inti tqila.
The potential risk to your unborn child is unknown.
Ir- riskju li jista ’ jkun hemm għat- tarbija ġol- guf mhux magħruf.
Keppra has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.
Keppra kellu effetti mhux mixtieqa fuq ir- riproduzzjoni, fi studji li saru fuq l- annimali b’ dożi li huma ogħla minn dawk li għandek bżonn biex tikkontrolla l- aċċessjonijiet.
Breast-feeding is not recommended during treatment.
Mhux irrikkmandat t- treddigħ waqt it- trattament.
Keppra may impair your ability to drive or operate any tools or machinery, as Keppra may make you feel sleepy.
Sewqan u tħaddim ta ’ magni Għaliex Keppra jista 'jħeddlek, jista ’ jkollu effett fuq l- ħila tiegħek li ssuq jew tagħmel użu minn għodda jew tħaddem magni,.
This is more likely at the beginning of treatment or after an increase in the dose.
Dan jista 'jiġri l- iżjed fil- bidu tat- trattament jew wara żieda fid- doża.
You should not drive or use machines until it is established that your ability to perform such activities is not affected.
M’ għandekx issuq jew tuża 'magni sakemm ma jiġi stabbilit li ma jaffettwax il- ħila tiegħek li tagħmel dawn l- attivitajiet.
HOW TO TAKE KEPPRA
KIF GĦANDEK TIEĦU KEPPRA
Dosage in adults and adolescents (12 to 17 years) weighing 50 kg or more:
Dożaġġ f’ adulti u addoloxxenti (12 sa 17 il- sena) li jiżnu 50 kg jew iżjed:
Take the number of tablets following your doctor’ s instructions. • General dose: between 1,000 mg (4 tablets) and 3,000 mg (12 tablets) each day. • Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Eżempju:
Example: if your daily dose is 1,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.
Jekk id- doża tiegħek hija 1, 000 mg kuljum, trid tieħu 2 pilloli filgħodu u 2 pilloli filgħaxija.
Dosage in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Dożaġġ fit- tfal (4 sa 11 il- sena) u addoloxxenti (12 sa 17 il- sena) li jiżnu inqas minn 50 kg:
Give to your child the number of tablets following your doctor’ s instructions. • General dose: between 20 mg/ kg and 60 mg/ kg each day. • Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Għati lit- tifla/ tifel tiegħek in- numru ta 'pilloli kif jgħidlek it- tabib. • Doża normali: bejn 20 mg/ kg u 60 mg/ kg kuljum. • Keppra trid tittieħed darbtejn kuljum, darba filgħodu u darba filgħaxija, bejn wieħed u ieħor fl - istess ħin kuljum.
Swallow Keppra tablets with a sufficient quantity of liquid (e. g. a glass of water).
Kif jittieħed Ibla il- pilloli Keppra ma ’ ammont xieraq ta 'likwidu (ez. tazza ilma).
Duration of treatment: • Keppra is used as a chronic treatment.
Kemm għandu jdum it- trattament • Keppra huwa wżat bħala trattament għal marda kronika.
You should continue Keppra treatment for as long as your doctor has told you. • Do not stop your treatment without your doctor’ s advice as this could increase your seizures.
Trid tibqa 'tieħu Keppra sakemm jgħidlek it- tabib tiegħek. • Twaqqafx it- trattament jekk ma jgħidlekx it- tabib għax dan jista ’ jżidlek l- aċċessjonijiet.
Should your doctor decide to stop your Keppra treatment, he/ she will instruct you about the gradual withdrawal of Keppra.
Jekk it- tabib jiddeċidi li jwaqqaf it- trattament tiegħek b’ Keppra, huwa/ hija jgħidlek kif għandek tnaqqas il- pilloli bil- mod.
Contact your doctor if you took more tablets than you should.
Jekk tieħu Keppra aktar milli suppost għandek Għarraf lit- tabib tiegħek jekk ħadt iżjed Keppra milli jmissek.
Contact your doctor if you have missed one or more doses.
Jekk tinsa tieħu Keppra Għarraf it- tabib tiegħek jekk insejt tieħu doża waħda jew iżjed.
Do not take a double dose to make up for a forgotten tablet.
M’ għandekx tieħu doża doppja biex tpatti għal xi pillola li tkun insejt tieħu.
If you stop taking Keppra:
Jekk tieqaf tieħu Keppra
105 If stopping treatment, as with other antiepileptic medicines, Keppra should be discontinued gradually to avoid an increase of seizures.
105 Bħal ma jsir b' mediċini oħra kontra l- epilessija, jekk tkun ser twaqqaf it- trattament, għandek tnaqqas Keppra bil- mod biex ma jkunx hemm żieda fl- aċċessjonijiet.
Like all medicines, Keppra can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, Keppra jista ’ jkollu effetti oħra, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor if you have any of the following and they worry you.
Għarraf lit- tabib tiegħek jekk għandek xi effetti minn dawn u qed jinkwetawk:
Very common side effects (> 10%) reported with Keppra are: • somnolence (sleepiness); • asthenia/ fatigue (tiredness).
L- effetti mhux mixtieqa komuni ħafna (> 10%) li ġew rappurtati b’ Keppra huma: ħedla ta ’ ngħas; astenja (għajja).
Common side effects (> 1% - 10%) reported with Keppra are: • nervous system disorders: dizziness (sensation of unsteadiness), convulsion, headache, hyperkinesia (hyperactivity), ataxia (impaired coordinated movements), tremor (involuntary trembling), amnesia (loss of memory), balance disorder (equilibrium disorder), disturbance in attention (loss of concentration), memory impairment (forgetfulness); • psychiatric disorders: agitation, depression, emotional instability/ mood swings, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems), thinking abnormal (slow thinking, unable to concentrate); • digestive disorders: abdominal pain, nausea, dyspepsia (indigestion), diarrhoea, vomiting; • nutrition disorders: anorexia (loss of appetite), weight increase • ear and labyrinth disorders: vertigo (sensation of rotation); • eye disorders: diplopia (double vision), vision blurred; • musculoskeletal and connective tissue disorders: myalgia (muscle pain); • injury: accidental injury; • infections: infection, nasopharyngitis; • respiratory disorders: cough (increase of pre-existing cough); • skin disorders: rash, eczema, pruritus; • blood disorders: decreased number of blood platelets.
Effetti komuni (> 1% - 10%) mhux mixtieqa li ġew rappurtati b’ Keppra huma: • Mard fis- sistema nervuża: sturdament (sensazzjoni li ser taqa '), aċċessjoni, uġigħ ta' ras, iperkinesja (iperattivita`), ataksja (movimenti mhux ko- ordinati), rogħda, amneżija (telf ta 'memorja), telf tal- bilanċ (mard ta ’ l- ekwilibriju), disturbi f’ attenzjoni (telf ta ’ konċentrazzjoni), telf ta ’ memorja (nisi); • Mard psikjatriċi: aġitazzjoni, depressjoni, instabilità emozzjonali / tibdil fil- burdata, ostilità jew aggressjoni, nuqqas ta' rqad, nervożiżmu jew irritabilità, disturbi fil- personalita`, (problemi fl - imġieba), ħsieb abnormali (ħsieb bil- mod, ma tistax tikkonċentra); • Mard gastro- intestinali: uġigħ f’ addomenu, dardir, indiġestjoni, dijarrea, rimettar; • Mard fin- nutrizzjoni: anoressija (telf t' aptit); żieda fil- piz • Mard fil- widna u fil- parti ta 'ġewwa tal- widna: vertigo (tħoss kollox idur bik); • Mard fil- għajn: viżjoni doppja, viżjoni mċajpra; • Mard muskolu- skeltrali u tal- connective tissue: majalġja (uġigħ fil- muskoli) • Korriment: korriment aċċidentali; • Infezzjonijiet: nażo- farinġite • Mard respiratorju: żieda fis- sogħla • Mard tal- ġilda: raxx, ekżema, ħakk. • Mard fid- demm: livell baxx ta' plejtlets fid- demm.
Other side effects reported with Keppra are: • nervous system disorders: paraesthesia (tingling); • psychiatric disorders: abnormal behaviour, anger, anxiety, confusion, hallucination, mental disorder, suicide, suicide attempt and suicidal ideation; • digestive disorders: pancreatitis, hepatic failure, hepatitis, liver function test abnormal; • nutrition disorders: weight loss; • skin disorders: hair loss; • blood disorders: decreased number of red blood cells, and/ or white blood cells.
Effetti mhux mixtieqa oħra huma: • Mard fis- sistema nervuża: parastesja (tingis); • Mard psikjatriċi: mġieba mhux normali, rabja, ansjetà, konfużjoni, depressjoni, alluċinazzjoniji, mard mentali, suwiċidju, attentat ta ’ suwiċidju u ħsibijiet ta ’ suwiċidju; • Mard diġestivi: pankreatite, insuffiċjenza tal- fwied, epatite, test tal- funzjoni tal- fwied abnormali; • Mard marbut man- nutrizzjoni: telf ta ’ piz; Xi effetti mhux mixtieqa bħal tħeddil, għajja u sturdament jistgħu jkunu iżjed komuni fil- bidu tat - trattament u meta tiżdied id- doża.
These effects should however decrease over time.
Madanakollu dawn l- effetti għandhom jonqsu maż- żmien.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok kellem lit- tabib jew spiżjar tiegħek.
HOW TO STORE KEPPRA
KIF TAĦŻEN KEPPRA
• Keep out of the reach and sight of children. • This medicinal product does not require any special storage conditions.
• Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Dan il- prodott mediċinali m’ għandux bżonn ebda ħtiġijiet speċjali għall- ħażna.
Do not use after the expiry date stated on the carton box and blister after EXP:.
M’ għandekx tuża wara d- data ta ’ skadenza li tidher fuq il- kaxxa u l- folja, wara JIS:.
What Keppra contains • The active substance is called levetiracetam.
106 X’ fih Keppra: • Is- sustanza attiva hi levetiracetam.
The other ingredients are:
Sustanzi oħra jinkludu:
Tablet core:
Il- qalba:
Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate.
Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate.
Film-coating:
Il- kisja tar- rita:
Opadry 85F20694 (Polyvinyl alcohol-part. hydrolyzed, Titanium dioxide (E171), Macrogol 3350, Talc, Indigo carmine aluminium lake (E132)).
Opadry 85F20694 (Polyvinyl alcohol- part. hydrolyzed, Titanium dioxide (E171), Macrogol 3350, Talc, indigo carmine aluminium lake (E 132)).
Keppra film-coated tablets are packed in blisters in cardboard boxes.
Keppra pilloli miksija b 'rita huma ppakkjati f' folji f' kaxxi tal- kartun.
Each tablet contains 250 mg of levetiracetam.
Kull pillola fiha 250 mg ta 'levetiracetam.
What Keppra looks like and contents of the pack The film-coated tablets are blue, oblong, scored and debossed with the code “ ucb” and “ 250” on one side.
Id- Dehra tal- prodott u d- daqs tal- pakkett: l- pilloli miksija b' rita huma blu, tawwalin, maqtuha minn nofs u mnaqqxa bil- kodiċi “ ucb ” u “ 250 ” fuq naħa waħda.
The cardboard boxes contain 20, 30, 50, 60, 100 and 200 film-coated tablets.
Il- kaxxi tal- kartun fihom 20, 30, 50, 60 u 100 pillola miksija b' rita.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
UCB Pharma S. A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
UCB Pharma SA, Allée de la Recherche 60, B- 1070 Bruxelles, Belġju.
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’ Alleud, Belgium.
UCB Pharma SA, Chemin du Foriest, B- 1420 Braine- l- Alleud, Belġju.
Local representatives For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Ir- rappreżentanti Lokali Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
Nederland UCB Pharma B. V.
Nederland Danmark UCB Pharma B. V.
Eesti UCB Pharma Oy Finland Tel: +358 9 229 0100
Eesti UCB Pharma Oy Finland Tel: +358- 9 2290 100
Tel: + 34 / 91 570 34 44
107 Tel: + 34 / 91 570 34 44
Suomi/ Finland UCB Pharma Oy Finland Puh/ Tel: + 358 9-229 0100
Suomi/ Finland UCB Pharma Oy Finland Puh/ Tel: + 358 / 9- 2290 100
Latvija UCB Pharma Oy Finland Tel: + 358 9 229 0100
Latvija UCB Pharma Oy Finland Tel: + 358- 9 2290 100
Lietuva UCB Pharma Oy Finland Tel: +358 9 229 0100
Lietuva UCB Pharma Oy Finland Tel: +358 - 9 2290 100
This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ [data]
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
108 PACKAGE LEAFLET:
108 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
INFORMATION FOR THE USER
Keppra 500mg pilloli miksija b’ rita Levetiracetam
Keppra 500 mg film-coated tablets.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
Levetiracetam
- Żomm dan il- fuljett.
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew spiżjar tiegħek.
You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you.
- Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lil persuni
Keppra 500 mg film-coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Keppra 500 mg pilloli miksija b 'rita hija mediċina għal kontra l- epilessija (użata biex tittratta l - aċċessjonijiet f- epilessija).
Keppra is used alone in the treatment of partial seizures in patients from 16 years of age
Keppra huwa wżat waħdu fit- trattament ta 'aċċessjonijiet tat- tip parzjali f' pazjenti minn 16 il- sena.
Keppra is used in patients who are already taking another antiepileptic medicine. • in the treatment of partial seizures in adults and children from 4 years age • in the treatment of myoclonic seizures in patients 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
Keppra huwa wżat f ’ pazjenti li diga ’ ikunu qiegħdin jieħdu mediċini oħra għal kontra l- epilessija • fit- trattament ta 'aċċessjonijiet tat- tip parzjali f ’ adulti u tfal minn 4 snin. • fit- trattament ta ’ aċċessjonijiet tat- tip mijokloniċi f ’ pazjenti 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
• Take special care with Keppra: • if you suffer from kidney problems, follow your doctor’ s instructions.
Oqgħod attent ħafna b’ Keppra • jekk int tbati minn problemi fil- kliewi, oqgħod fuq li jgħidlek it- tabib.