FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint was disease-free survival, defined as the interval between randomisation and the earliest occurrence of loco-regional recurrence, distant metastasis, or contralateral breast cancer.
Maltese: L-endpoint primarju kien is-sopravivenza mingħajr mard, iddefinit bħala l-intervall bejn irrandomizzazzjoni u l-aktar dehra bikrija ta' rikorrenza lokoreġjonali, metastasi distanti, jew kanċer tas-sider kontralaterali.
English: Ritemvia (rituximab)
Maltese: Ritemvia (rituksimab)
English: The full EPAR for Ritemvia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ritemvia
Maltese: ema.europa.eu/medicines/human/EPAR/ritemvia
English: Other information about Ritemvia
Maltese: Informazzjoni oħra dwar Ritemvia
English: Ritemvia received a marketing authorisation valid throughout the EU on 13 July 2017.
Maltese: Ritemvia rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-13 ta' Lulju 2017.
English: Ritemvia is a ‘biosimilar medicine'.
Maltese: Ritemvia huwa ‘mediċina bijosimili'.
English: The study showed that Ritemvia and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Ritemvia and 73% (43 of 59 patients) with MabThera.
Maltese: L-istudju wera li Ritemvia u MabThera kellhom effetti komparabbli fuq is-sintomi tal-artrite: wara 24 ġimgħa, il-proporzjon ta' pazjenti li kellhom titjib ta' 20 % fil-punteġġ tas-sintomi (imsejjaħ ACR20) kien ta' 74 % (114 minn 155 pazjent) b'Ritemvia u ta' 73 % (43 minn 59 pazjent) b'MabThera.
English: Ritemvia contains the active substance rituximab.
Maltese: Ritemvia fih is-sustanza attiva rituksimab.
English: The reference medicine for Ritemvia is MabThera.
Maltese: Il-mediċina ta' referenza għal Ritemvia hija MabThera.
English: In this study improvement was seen in 96% of cases (67 of 70 patients) with Ritemvia and 90% (63 of 70 patients) with Rituxan.
Maltese: F'dan l-istudju deher titjib f'96 % tal-każijiet (67 minn 70 pazjent) b'Ritemvia u 90 % (63 minn 70 pazjent) b'Rituxan.
English: Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare and severe brain infection known as progressive multifocal leukoencephalopathy (PML).
Maltese: Effetti sekondarji serji oħra jinkludu riattivazzjoni tal-epatite B (ir-ritorn ta' infezzjoni attiva preċedenti fil-fwied bil-virus tal-epatite B) u infezzjoni fil-moħħ rari u severa magħrufa bħala lewkoenċefalopatija multifokali progressiva (PML).
English: Further evidence came from supportive studies including one involving 121 patients with advanced follicular lymphoma, where adding Ritemvia to chemotherapy medicines was at least as effective as adding Rituxan, the US version of MabThera.
Maltese: Evidenza ulterjuri ġiet minn studji ta' sostenn inkluż wieħed li involva 121 pazjent b'linfoma follikulari avvanzata, fejn iż-żieda ta' Ritemvia mal-mediċini ta' kimoterapija kienet tal-inqas effettiva daqs iżżieda ta' Rituxan, il-verżjoni Amerikana ta' MabThera.
English: Laboratory studies comparing Ritemvia with MabThera have shown that the active substance in Ritemvia is highly similar to that in MabThera in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Ritemvia ma' MabThera wrew li s-sustanza attiva f'Ritemvia hija simili ħafna għal dik f'MabThera f'termini ta' struttura, purità u attività bijoloġika.
English: The active substance in Ritemvia, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B cells (types of white blood cells).
Maltese: Is-sustanza attiva f'Ritemvia, ir-rituksimab, hija antikorp monoklonali (tip ta' proteina) imfassal biex jagħraf u jeħel ma' proteina msejħa CD20 preżenti fuq il-wiċċ taċ-ċelloli B (tipi ta' ċelloli bojod taddemm).
English: What are the risks associated with Ritemvia?
Maltese: X'inhuma r-riskji assoċjati ma' Ritemvia?
English: The company that markets Ritemvia will provide doctors and patients using the medicine for noncancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Maltese: Il-kumpanija li tqiegħed Ritemvia fis-suq ser tipprovdi lit-tobba u lill-pazjenti li jużaw il-mediċina għal kondizzjonijiet mhux tal-kanċer b'materjal edukattiv inkluż informazzjoni dwar il-ħtieġa li l-mediċina tingħata fejn ikun hemm disponibbli faċilitajiet għar-risuxxitazzjoni u dwar ir-riskju ta' infezzjoni, inkluż PML.
English: The most common serious side effects are infusion reactions, infections and, in cancer patients, heart-related problems.
Maltese: L-effetti sekondarji serji l-aktar komuni huma reazzjonijiet relatati mal-infużjoni, infezzjonijiet u, f'pazjenti bil-kanċer problemi relatati mal-qalb.
English: In addition, a study comparing Ritemvia to MabThera in patients with rheumatoid arthritis (which can support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are similarly effective, and a supportive study in follicular lymphoma showed effectiveness in cancer.
Maltese: Barra minn hekk studju li jqabbel Ritemvia ma' MabThera f'pazjenti b'artrite rewmatojde (li jista' jappoġġja l-użu tiegħu f'disturbi infjammatorji oħra bħal GPA u MPA) wera li ż-żewġ mediċini huma effettivi b'mod simili, u studju ta' sostenn dwar linfoma follikulari wera leffettività fil-kanċer.
English: This means that Ritemvia is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Ritemvia huwa simili ħafna għal mediċina bijoloġika oħra (il-‘mediċina ta' referenza') li diġà hija awtorizzata fl-UE.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ritemvia has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Ritemvia għandu struttura, purità u attività bijoloġika simili ħafna għal MabThera u jiġi distribwit fil-ġisem bl-istess mod.
English: Studies have also shown that giving Ritemvia produces similar levels of the active substance in the body to giving MabThera.
Maltese: L-istudji wrew wkoll li lgħoti ta' Ritemvia jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' MabThera.
English: The safety of Ritemvia has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Maltese: Is-sigurtà ta' Ritemvia ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza MabThera.
English: When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL, where B cells have become cancerous.
Maltese: Meta r-rituksimab teħel ma' CD20, tikkawża l-mewt taċ-ċelloli B, li jgħin fil-linfoma u fis-CLL, fejn iċ-ċelloli B ikunu saru kanċerużi.
English: How does Ritemvia work?
Maltese: Kif jintuża Ritemvia?
English: For the full list of side effects of Ritemvia, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Ritemvia, ara l-fuljett ta' tagħrif.
English: As for all medicines, data on the use of Ritemvia are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ritemvia hija ssorveljata kontinwament.
English: All these data were considered sufficient to conclude that Ritemvia will behave in the same way as MabThera in terms of its effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha tqieset biżżejjed sabiex jiġi konkluż li Ritemvia ser jaġixxi bl-istess mod bħal MabThera f'termini ta' effikaċja u sigurtà fl-użu approvat tiegħu.
English: In addition, Ritemvia has been compared with MabThera given into a vein in a main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease).
Maltese: 372 pazjent bl-artrite rewmatojde attiva (marda infjammatorja)
English: How is Ritemvia used?
Maltese: Ritemvia?
English: Doctors prescribing Ritemvia for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.
Maltese: Ilpazjenti jistgħu jirċievu wkoll mediċini oħra, skont il-kondizzjoni li tkun qed tiġi kkurata.
English: Depending on the condition it is used to treat, Ritemvia may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids).
Maltese: Skont il-kondizzjoni li jintuża biex jikkura, Ritemvia jista' jingħata mal-kimoterapija (mediċini oħra kontra l-kanċer) jew ma' mediċini li jintużaw għal disturbi infjammatorji (kortikosterojdi).
English: Strength Pharmaceutical form Route of administration Packaging Package size EU/1/09/536/001 Topotecan Actavis 1 mg l t o r
Maltese: Mnejn jingħata Il-pakkett
English: Accord Healthcare Limited Sage house, 319 Pinner road North Harrow HA1 4HF
Maltese: Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow HA1 4HF, Middlesex , IrRenju Unit
English: Contains sunset yellow (E110).
Maltese: TA' EĊĊIPJENTI Fih sunset yellow (E110).
English: North Harrow, Middlesex HA1 4HF United Kingdom
Maltese: North Harrow, Middx HA1 4HF Ir-Renju Unit
English: • amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia
Maltese: • amneżija (telf ta' memorja),impediment tal- memorja (tinsa), ko-ordinazzjoni abnormali/ataxja
English: Date of first authorisation: 03rd October 2011 Date of latest renewal: 22nd July 2016
Maltese: Data tal-aħħar tiġdid: 22 Lul 2016
English: The active ingredient is levetiracetam.
Maltese: Is-sustanza attiva hija levetiracetam.
English: CLcr (ml/min) CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73 BSA subject (m2)
Maltese: CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73
English: Creatinine clearance (ml/min/1.73m2)
Maltese: (ml/min/1.73 m2)
English: 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.
Maltese: Levitiracetam 1,000 mg kuljum ma kellux effett fuq il-farmakokinetika ta' kontraċettivi orali (ethinylestradiol u levonorgestrel); il-parametri endokrinali (luteinizing hormone u progesterone) ma kienux modifikat.
English: The tablet core ingredients are: croscarmellose sodium, povidone K-30, colloidal anhydrous silica, magnesium stearate (E470b)
Maltese: Is-sustanzi tal-qalba tal-pillola huma: croscarmellose sodium, povidone K-30, colloidal anhydrous silica, magnesium stearate (E470b)
English: 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)
Maltese: 500 sa 1,500 mg darbtejn kuljum 500 sa 1,000 mg darbtejn kuljum 250 sa 750 mg darbtejn kuljum 250 sa 500 mg darbtejn kuljum
English: Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified.
Maltese: Levitiracetam 2,000 mg kuljum ma kellux effett fuq il-farmakokinetika ta' digoxin u warfarin; il-prothrombin times ma kienux modifikat.
English: Metabolism and nutrition disorders
Maltese: Disturbi fil metaboliżmu u nutrizzjoni
English: 43.6% of the levetiracetam treated patients and 19.6% of the patients on placebo were considered as responders.
Maltese: 43.6 % tal-pazjenti trattati b'levetiracetam u 19.6 % talpazjenti fuq plaċebo kienu kkonsidratai bħala li rrispondew.
English: • severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);
Maltese: • reazzjonijiet allerġiċi serji (DRESS, reazzjoni anafillattika [reazzjoni severa u importanti], edima ta' Quincke [nefħa fil-wiċċ, xofftejn u griżmejn]);
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Maltese: Polyvinyl alcohol Titanium dioxide (E171)
English: 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 30 X 1 film-coated tablet 60 X 1 film-coated tablet 100 X 1 film-coated tablet
Maltese: 100 pillola miksija b'rita 200 pillola miksija b'rita 30 X 1 pillola miksija b'rita 60 X 1 pillola miksija b'rita 100 X 1 pillola miksija b'rita
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji toraċiċi u
English: With continued long-term treatment, 8.6% of the patients were seizure-free for at least 6 months and 7.8% were seizure-free for at least 1 year.
Maltese: B'trattament kontinwu fit-tul, 8.6 % tal-pazjenti kienu mingħajr aċċessjonijiet għal mill-inqas 6 xhur u 7.8 % kienu mingħajr aċċessjonijiet għal mill-inqas sena.
English: Alopecia,eczema, pruritus,
Maltese: Alopacja, ekzema,
English: 10 to 20 mg /kg (0.10 to
Maltese: 10 sa 20 mg/kg (0.10 sa
English: 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%
Maltese: 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 ittrattamenti kienet ta' 0.2 %(95 % CI:-7.8 8.2).
English: Depression, hostility/ aggression, anxiety, insomnia, nervousness/irritabi lity
Maltese: Depressjoni, ostilita`/ aggressjoni, anzjeta`, insomnja,
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Maltese: Ir-reazzjonijiet avversi kienu ppreżentati f'ordni ta' gravita` minn ħafna għal ftit u il-frekwenza huma mfissra kif ġejjin: komuni hafna (≥1/10); komuni: (>1/100 sa ≤1/10); mhux komuni: (>1/1,000 sa ≤1/100) u rari:
English: • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Maltese: • Fit-trattament ta' aċċessjonijiet primarji u ġeneralizzati tat-tip tonic-clonic f'adulti u addoloxxenti minn 12-il sena b'Epilessija Ġeneralizzata Idjopatika.
English: Four embryo-foetal development studies were performed in rabbits covering doses of 200, 600, 800, 1200 and 1800 mg /kg/day.
Maltese: Erba' studji dwar l-iżvillup tal-embriju u l-fetu saru fil-fniek li koprew dożi ta' 200, 600, 800, 1200 u 1800 mg/kg/ġurnata.
English: 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.
Maltese: Is-sustanza attiva, levetiracetam hija derivattiva ta' pyrrolidone (S-enantiomer ta' α-ethyl-2-oxo-1pyrrolidine acetamide), u ma jixbahx kimikament lil sustanzi attivi oħrajn li jintużaw kontra l epilessija.
English: Levetiracetam Accord film-coated tablets 250 mg, 500 mg, 750 mg and 1000 mg are packed in PVC-Alu blister pack.
Maltese: Levetiracetam Accord pilloli miksija b'rita 250 mg, 500 mg, 750 mg u 1000 mg huma ppakkjati f'pakkett tal-folji tal-PVC-Alu.
English: The NOAEL (No Observed Adverse Effect Level) was 3600 mg /kg/day for pregnant female rats (x 12 the MRHD on a mg/m2basis) and 1200 mg /kg/day for fetuses.
Maltese: The NAOEL (Livell ta'Ebda Effett Avvers Osservat) kien ta' 3600 mg/kg/ġurnata għal firien feminili tqal ( x12 ilMRHD fuq bażi ta' mg/m2) u 1200 mg/kg/ġurnata għal feti.
English: Thrombocytopenia, leukopenia Pancytopenia, neutropenia, agranulocytosis
Maltese: Trombositopinja, lukopinja
English: anger, confusion, panic attack,emotional instability/mood swings, agitation;
Maltese: konfużjoni, attakk ta' paniku, instabilta` emozzjonali/tibdil fil-burdati, agitazzjoni;
English: Single pack containing 10, 20, 30, 50, 60, 100, 200 tablets.
Maltese: Pakkett waħdieni li fih 10, 20, 30, 50, 60, 100, 200 pillola.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
Maltese: Reazzjoni għall-mediċina b' esinofilja u sintomi sistemiċi (DRESS), Ipersensittivita` (li jinkludi anġjoedema u anafillassi))
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics ATC code: N03AX14.
Maltese: Kategorija farmakoterapewtika: mediċini għall-kontra l-epilessija, mediċini għall-kontra l-epilessija oħra, Kodiċi ATC:
English: The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination, for young adolescents,children and infants, using the following formula (Schwartz formula):
Maltese: Il-CLcr f' ml/min/1.73 m2 tista' tigi kkalkulata mill-livell ta' krejatinina fis-serum (mg/dl), għal addoloxenti żgħar, tfal u trabi, billi tuża din il-formula (formula Schwartz):
English: Height (cm) x ks CLcr (ml/min/1.73 m2) = ----------------------------------Serum Creatinine (mg/dl)
Maltese: CLcr (ml/min/1.73 m2) = -------------------------------Kreatinina fis-serum (mg/dl)
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviuor as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behavior Checklist).
Maltese: Riżultati li għandhom x'jaqsmu mal-funzjoni talimġiba u dik emozjonali juru aggravament fil-pazjenti trattati b' Levetiracetam f'imġiba aggressiva kif imkejjel b'mod standardizzat u sistematiku bl-użu ta' strument validat (CBCL - Achenbach Child Behavior Checklist).
English: 7 to 21 mg /kg (0.07 to 0.21 ml/kg) twice daily
Maltese: 7 sa 21 mg/kg (0.07 sa 0.21 ml/kg) darbtejn kuljum
English: 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.
Maltese: F'adulti, l-effiċjenza ta' levetiracetam kiem muri fi 3 studji double-blind ikkontrollati minn plaċebo f dożi ta' 1000 mg, 2000 mg, jew 3000 mg/ kuljum, mogħtija f' 2 dożi separati, b'trattament li dam sa 18 il-ġimgħa.
English: A dose of 20 mg /kg/day titrating to 40 mg /kg/day for infants one month to less than six months and a dose of 25 mg /kg/day titrating to 50 mg /kg/day for infants and children 6 months to less than 4 years old, was use in this study.
Maltese: Doża ta' 20 mg/kg/ġurnata sa 40 mg/kg/ġurnata għal trabi ta' xahar sa inqas minn sitt xhur u doża ta' 25 mg/kg/ġurnata sa 50 mg/kg/ġurnata għal trabi u tfal minn 6 xhur sa inqas minn 4snin t'eta`, kienu wżati f'dan l-istudju.
English: Following single oral dose administration (20 mg /kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
Maltese: Wara li ngħatat doża orali waħda li tammonta għal 20 mg/kg lil tfal bl-epilessija (6 sa 12 il-sena), ilhalf life ta' levetiracetam kienet 6.0 sigħat.
English: As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg /kg/day levetiracetam.
Maltese: 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.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Maltese: sindromu ta' StevensJohnson,
English: Each film-coated tablet contains 250 mg, 500 mg, 750 mg or 1000 mg of levetiracetam.
Maltese: Kull pillola miksija b'rita fiha 250 mg, 500 mg, 750 mg jew 1000 mg ta' levetiracetam.
English: Additionally, the tablets are also available in unit dose blister for the pack size of 30x1, 60x1 and 100x1 tablets.
Maltese: Barra minn hekk, il-pilloli huma disponibbli wkoll f'folja ta' doża waħda għad-daqs tal-pakkett ta' 30x1, 60x1 u 100x1 pillola.
English: What Levetiracetam Accord contains:
Maltese: Jekk tinsa tieħu Levetiracetam Accord:
English: INFORMATION IN BRAILLE Levetiracetam Accord 1000 mg
Maltese: Levetiracetam Accord 1000 mg
English: 250 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc
Maltese: 250 mg: polyvinyl alco hol, titanium dioxide (E171), macrogol, talc
English: Levetiracetam Accord 250 mg film-coated tablets Levetiracetam Accord 500 mg film-coated tablets Levetiracetam Accord 750 mg film-coated tablets Levetiracetam Accord 1000 mg film-coated tablets
Maltese: Levetiracetam Accord 250 mg pilloli miksija b'rita Levetiracetam Accord 500 mg pilloli miksija b'rita Levetiracetam Accord 750 mg pilloli miksija b'rita Levetiracetam Accord 1000 mg pilloli miksija b'rita
English: The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
Maltese: L-effiċjenza ta' l-estrazzjoni taddijaliżi hija ta' 60 % għal levetiracetam u ta' 74 % għall-prodott ewlieni tal-metaboliżmu.
English: (3) A 15 mg /kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Maltese: (3) Doża kbira ta' 15 mg/kg (0.15 ml/kg) hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
English: Dose and frequency(1) Infants 1 to less than 6 months
Maltese: Doża u frekuenza (1) Trabi ta' bejn xahar sa inqas minn 6 xhur
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination,anger, confusional state, panic attack, affect lability/mood swings, agitation
Maltese: Attenta ta' suwiċidju, ħsibijiet ta' suwiċidju,mard psikotiċi, mġieba abnormali, alluċinazzjonijiet, rabja, stat konfużjonali , attakk ta' paniku, tibdil flemozzjonijiet/tibdil fil-burdati,
English: 750 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), sunset yellow FCF(E110)
Maltese: 500 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172) 750 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), sunset yellow
English: Levetiracetam oral solution is the preferred formulation for use in this population.
Maltese: Levetiracetam soluzzjoni orali hija l-formulazzjoni preferita għall-użu f'din il-popolazzjoni.
English: Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Maltese: Terapija miżjuda għal adulti (≥18-il sena ) u addoloxxenti (12 sa 17-il sena) li jiżnu iżjed minn 50 kg jew iżjed.
English: INFORMATION IN BRAILLE Levetiracetam Accord 750 mg
Maltese: Levetiracetam Accord 750 mg
English: Gastrointestinal disorders
Maltese: Sogħla medjastinali Disturbi gastrointestinali
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew derivattivi oħrajn ta' pyrrolidone, jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: 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.
Maltese: 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.
English: INFORMATION IN BRAILLE Levetiracetam Accord 250 mg
Maltese: Levetiracetam Accord 250 mg
English: The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50% reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Maltese: Il-kejl primarju ta' effettivita` kienet ir-rata ta' pazjenti li rrispondew (persentaġġ tal-pazjenti b' ≥ 50 % tnaqqis mill-linja bażi fil-frekwenza tal-medda ta' aċċessjonijiet tat-tip partial onset f'ġurnata) mkejla b' blinded central reader bl'użu ta' vidjo EEG ta' 48 siegħa.