FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC in accordance with Article 107j(3) of Directive 2001/83/EC, recommended by majority that a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study, as well as a drug utilisation study (see Annex IV - Conditions of marketing Authorisations); b. the marketing authorisation holders should implement risk minimisation measures; c. the marketing authorisations of the cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products (see Annex I) should be varied (in accordance with changes to the product information as set out in Annex III).
Maltese: Il-PRAC skont l-Artikolu 107j(3) tad-Direttiva 2001/83/KE, irrakkomanda b'maġġoranza li a. id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom jisponsorjaw studju flimkien mal-valutazzjoni ta' segwitu tar-riżultati ta' dak l-istudju, kif ukoll studju dwar l-użu talmediċina (ara Anness IV - Kundizzjonijiet tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq); b. id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom jimplimentaw miżuri għallminimizzazzjoni tar-riskji; c. l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali li fihom cyproterone acetate/ethinylestradiol (2mg/0.
English: French assessment report February 2013 Rationale for the triggering of procedure under Article 107i of Directive 2001/83/EC on cyproterone/ethinylestradiol (2mg/0.035mg) presented by ANSM, France history of VTE before prescribing EE-containing medicinal products (e.g. combined oral contraceptives (COC)) is, therefore, recommended in the product information of the products.
Maltese: Rapport ta' valutazzjoni Franċiż Frar 2013 Raġuni għall-attivazzjoni tal-proċedura skont l-Artikolu 107i tadDirettiva 2001/83/KE dwar cyproterone / ethinylestradiol (2mg/0.
English: The wording agreed by the PhVWP is entirely implemented only in 11 Member States.
Maltese: Il-kitba miftiehma mill-PhVWP hija totalment implimentata fi 11-il Stat Membru biss.
English: This translates into a global spontaneous reporting rate of 1.2 non-fatal TE reports per 100,000 women-years with CPA/EE (2mg/0.035mg).
Maltese: Dan isarraf f'rata globali ta' rapportar spontanju ta' 1.2 rapport mhux fatali ta' TE għal kull 100,000 mara-snin b'CPA/EE (2mg/0.
English: The calculations met the precision requirements of the Guideline on clinical investigation of steroid contraceptives in women2.
Maltese: Il-kalkoli laħqu r-rekwiżiti ta' preċiżjoni tal-Linja Gwida dwar l-investigazzjoni klinika ta' kontraċettivi sterojdi fin-nisa2.
English: Seborrhoea has mainly been evaluated in the context of acne.
Maltese: Is-seborrea ġiet prinċipalment evalwata fil-kuntest tal-akne.
English: Patients were between 13 and 63 years old (mean 27 years, median 25 years) at the time of the event.
Maltese: Il-pazjenti kienu bejn it-13 u s-63 sena (medja ta' 27 sena, medjan ta' 25 sena) fil-ħin tal-avveniment.
English: In addition the contraceptive effect of CPA/EE (2mg/0.035mg) was investigated in a European Active Surveillance (EURAS) study.
Maltese: 035mg) kien investigat fi studju Ewropew ta' Sorveljanza Attiva (EURAS).
English: The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience on the safety of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products, as well as stakeholders' submissions in particular with regards to the thromboembolic events.
Maltese: Il-PRAC irreveda d-dejta kollha disponibbli minn studji kliniċi, studji farmakoepidemjoloġiċi, milletteratura pubblika, l-esperjenza ta' wara t-tqegħid fis-suq dwar is-sigurtà ta' prodotti mediċinali li fihom cyproterone acetate/ethinylestradiol (2mg/0.
English: In this study almost 67% of women prescribed CPA-containing preparations remembered after the discussion with their healthcare professional that their individual prescription was written for acne and/or PCOS, indicating that the skin condition was discussed during the counselling and was mentioned as the main reason to prescribe CPA/EE (2mg/0.035mg).
Maltese: F'dan l-istudju kważi 67% tan-nisa li ġew preskritti preparazzjonijiet li fihom CPA ftakru wara ddiskussjoni mal-professjonist tal-kura tas-saħħa tagħhom li l-preskrizzjoni individwali tagħhom kienet inkitbet għall-akne u/jew PCOS, li jindika li l-kundizzjoni tal-ġilda kienet ġiet diskussa matul ilkonsulenza u ssemmiet bħala r-raġuni ewlenija biex CPA/EE (2mg/0.035mg) jiġi preskritt.
English: The CMDh having considered the PRAC recommendation dated 16 May 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC reached a position on the variation to the terms of the marketing authorisations of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Maltese: Is-CMDh wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata s-16 ta' Mejju 2013 skont lArtikolu 107k(1) u (2) tad-Direttiva 2001/83/KE laħaq pożizzjoni dwar il-varjazzjoni lit-termini talawtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali li fihom cyproterone acetate/ ethinylestradiol (2mg/0.
English: Cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products are known to increase risk of thromboembolic events (TE).
Maltese: 035mg) huma magħrufa li jżidu r-riskju ta' avvenimenti tromboemboliċi (TE).
English: It also reduces androgen synthesis by a negative feedback effect on the hypothalamo-pituitary-ovarian axis.
Maltese: Inaqqas ukoll is-sintesi tal-androġeni permezz ta' effett ta' feedback negattiv fuq l-assi ipotalamikapitwitarja-ovarja.
English: • For the condition of alopecia in view of the overall available safety data, in particular in relation to the risk of serious thromboembolic events, and very limited efficacy data, the PRAC concluded in accordance with Article 116 of Directive 2001/83/EC that the risk-benefit balance is not favourable and therefore these medicinal products should no longer be indicated in this therapeutic indication.
Maltese: • Għall-kundizzjoni tal-alopeċja fid-dawl tad-dejta globali disponibbli dwar is-sigurtà, b'mod partikulari fir-rigward tar-riskju ta' avvenimenti tromboemboliċi serji, u dejta limitata ħafna dwar leffikaċja, il-PRAC ikkonkluda skont l-Artikolu 116 tad-Direttiva 2001/83/KE li l-bilanċ talbenefiċċju-riskju mhuwiex favorevoli u għalhekk dawn il-prodotti mediċinali m'għandhomx jibqgħu jiġu indikati f'din l-indikazzjoni terapewtika.
English: The primary outcomes of interest are cardiovascular events, in particular the incidence of VTE and ATE, during oral contraception use.
Maltese: Ir-riżultati primarji ta' interess huma avvenimenti kardjovaskulari, b'mod partikulari l-inċidenza ta' VTE u ATE, matul l-użu tal-kontraċezzjoni orali.
English: The PRAC considered that a Direct Healthcare Professional Communication (DHPC) was needed to communicate the outcome of the present review.
Maltese: Il-PRAC ikkunsidra li kien hemm il-ħtieġa ta' Komunikazzjoni Diretta lill-Professjonisti tal-Kura tasSaħħa (DHPC) biex tikkomunika r-riżultat tar-reviżjoni attwali.
English: The effects on hirsutism and seborrhoea have mainly been studied in the context of treatment of acne and/or polycystic ovary syndrome (PCOS).
Maltese: L-effetti fuq lirsutiżmu u s-seborrea ġew prinċipalment studjati fil-kuntest tal-kura tal-akne u/jew is-sindromu talovarji poliċistiċi (PCOS).
English: No comparative safety data vs products that are registered for the treatment for acne/hirsutism/PCOS are presented.
Maltese: Ma ġiet ippreżentata l-ebda dejta komparattiva dwar is-sigurtà kontra prodotti rreġistrati għall-kura tal-akne/irsutiżmu/PCOS.
English: Overall summary of the scientific evaluation of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal product(s) by PRAC
Maltese: Prodotti mediċinali li fihom cyproterone acetate/ethinylestradiol (2mg/0.
English: For 879 (90.8%) of 968 TE cases, CPA/EE (2mg/0.035mg) was the only suspected drug.
Maltese: 8%) minn 968 każ ta' TE, CPA/EE (2mg/0.
English: In general, cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products are authorised for treatment of androgenic symptoms in women, such as pronounced forms of acne, seborrhoea, and mild forms of hirsutism.
Maltese: 035mg) huma awtorizzati għall-kura ta' sintomi androġenċi fin-nisa, bħal forom evidenti ta' akne, seborrea, u forom ħfief ta' irsutiżmu.
English: In this study, around 60% of women prescribed a CPA/EE-containing preparation specifically reported in the baseline questionnaire that their CPA/EE (2mg/0.035mg) prescription was due to acne and/or polycystic ovary syndrome (PCOS).
Maltese: F'dan l-istudju, madwar 60% tan-nisa li ġew preskritti preparazzjoni li fiha CPA/EE fil-kwestjonarju tallinja bażi speċifikament irrapportaw li l-preskrizzjoni tagħhom ta' CPA/EE (2mg/0.035mg) kienet minħabba l-akne u/jew is-sindromu tal-ovarji poliċistiċi (PCOS).
English: • The PRAC also noted the available data concerning the hormonal contraceptive effect of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products.
Maltese: • Il-PRAC ikkonferma r-riskju magħruf ta' tromboemboliżmu ta' prodotti mediċinali li fihom cyproterone acetate/ ethinylestradiol (2mg/0.
English: For the treatment of acne, topical therapies are applied for mild to moderate acne without hyperandrogenic state.
Maltese: Għall-kura tal-akne, għall-akne minn ħafifa sa moderata mingħajr stat iperandroġeniku jiġu applikati terapiji topiċi.
English: The CMDh, having considered the PRAC recommendation dated 16 May 2013 with regards to the cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products, agrees with the recommendation therein as stated below:
Maltese: Is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata s-16 ta' Mejju 2013 fir-rigward ta' prodotti mediċinali li fihom cyproterone acetate/ethinylestradiol (2mg/0.
English: The off-label use was defined according to the therapeutic indications for CPA/EE (2mg/0.035mg) as SmPC indication statements differ from country to country on the basis of national responses of health authorities to the EMA Pharmacovigilance Working Party (PhVWP) review of the product conducted in
Maltese: 035mg) peress li d-dikjarazzjonijiet dwar l-indikazzjoni fl-SmPC ivarjaw minn pajjiż għall-ieħor abbażi tattweġibiet nazzjonali tal-awtoritajiet tas-saħħa għar-reviżjoni tal-prodott tal-Grupp ta' Ħidma ta' Farmakoviġilanza (PhVWP) tal-EMA li saret fl-2002.
English: In January 2013 the French medicines agency (ANSM) took the decision to suspend cyproterone acetate/ethinylestradiol (CPA/EE) (2mg/0.035mg) containing medicinal products in France within three months.
Maltese: F'Jannar 2013 l-awtorità tal-mediċini Franċiża (ANSM) ħadet id-deċiżjoni li tissospendi prodotti mediċinali li fihom cyproterone acetate/ethinylestradiol (CPA/EE) (2mg/0.
English: The combination of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) acts simultaneously as a hormonal contraceptive.
Maltese: 030mg ethinylestradiol) u ta' kontraċettivi orali u CPA/EE (2mg/0.035mg), li sar f'6 pajjiżi Ewropej u fl-Istati Uniti.
English: It has to be noted that Polycystic ovarian syndrome (PCOS) mentioned by HCPs as an indication reflects the use of CPA/EE for the treatment of androgen related symptoms of PCOS such as acne or hirsutism.
Maltese: Barra minn hekk il-PRAC innota li dawn il-prodotti mediċinali għandhom effetti ta' kontraċettivi ormonali u bħala tali l-użu konkomitanti ma' kontraċettivi ormonali oħra huwa kontraindikat.
English: The PRAC is of the opinion that the benefits of CPA/EE (2mg/0.035mg) containing medicinal products continue to outweigh the risks in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age.
Maltese: 035mg) ikomplu jegħlbu r-riskji fil-kura ta' akne moderata sa severa relatata ma' sensittività għall-androġeni (bi jew mingħajr seborrea) u/jew irsutiżmu, f'nisa ta' età riproduttiva.
English: These studies investigate the safety of the combined oral contraceptives YAZ (3 mg drospirenone/0.020mg ethinylestradiol) and Qlaira (dienogest/estradiol valerate, step down dose regimen) respectively.
Maltese: 020mg ethinylestradiol) u Qlaira (dienogest/estradiol valerate, reġim ta' tnaqqis fiddoża) rispettivament.
English: 1 Article 35 of Directive 2001/82/EC
Maltese: 1 Artikolu 35 tad-Direttiva 2001/82/KE
English: 1 July 2010
Maltese: fl-1 ta' Lulju 2010
English: The rapporteur and co-rapporteur appointed were: Mrs R. Kearsley and Dr J.G.
Maltese: Ir-rapporteur u l-ko-rapporteur maħtura kienu: is-Sinjura R. Kearsley u t-Tabib J.G. Beechinor, rispettivament.
English: The referral procedure started on 13 May 2009.
Maltese: Il-proċedura ta' referenza bdiet fit-13 ta' Mejju 2009.
English: On 23 November 2009, Ascor Chimici s.r.l., and on 3 December 2009, Ceva Santé Animale notified the Agency of their intention to request the re-examination of the CVMP opinion adopted on 11 November
Maltese: Fit-23 ta' Novembru 2009, Ascor Chimici s.r.l., u fit-3 ta' Diċembru 2009, Ceva Santé Animale innotifikaw lill-Aġenzija bl-intenzjoni tagħhom li jitolbu l-eżami mill-ġdid tal-opinjoni tas-CVMP adottata fil-11 ta' Novembru 2009.
English: On 9 March 2010 the CVMP adopted a final opinion confirming the recommendation, included in its opinion of 11 November 2009, that variations are necessary to the terms of the marketing authorisations for veterinary medicinal products containing (fluoro)quinolones intended for foodproducing species where it has been identified that the SPC and package leaflet have not been updated in line with the precautionary phrases in the CVMP “Reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance” (EMEA/CVMP/416168/2006).
Maltese: Fid-9 ta' Marzu 2010, is-CVMP adotta opinjoni finali li tikkonferma r-rakkomandazzjoni, inkluża flopinjoni tiegħu tal-11 ta' Novembru 2009, li hemm bżonn ta' varjazzjonijiet għat-termini talawtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali veterinarji li fihom (fluoro)quinolones maħsubin għall-ispeċi li jipproduċu l-ikel fejn ġie identifikat li l-SPC u l-fuljett ta' tagħrif ma ġewx aġġornati skont il-frażijiet ta' prekawzjoni fil-“Karta ta' riflessjoni dwar l-użu ta' fluoroquinolones flannimali li jipproduċu l-ikel - Prekawzjonijiet għall-użu fl-SPC rigward il-gwida għall-użu prudenti” tasCVMP (EMEA/CVMP/416168/2006).
English: Opinion following an Article 35F F referral for all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species
Maltese: Opinjoni wara referenza skont l-Artikolu 35F F għall-prodotti veterinarji mediċinali kollha li fihom quinolones inklużi fluoroquinolones intenzjonati għall-użu fl-ispeċi li jipproduċu l-ikel
English: On 15 May 2009 the European Commission submitted a revised notification to the Agency, in which it agreed to the CVMP proposal to take a step-wise approach to achieve the aim mentioned above and to limit the scope of the current referral procedure to the harmonisation of the warnings on prudent use included in the Summary of Product Characteristics (SPCs) for these classes of veterinary medicinal product in line with those recommended in the CVMP document “Reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)”.
Maltese: Fil-15 ta' Mejju 2009, il-Kummissjoni Ewropea ssottomettiet notifika riveduta lill-Aġenzija, li fiha qablet mal-proposta tas-CVMP li jittieħed approċċ pass, pass biex jintlaħaq l-għan imsemmi hawn fuq u biex jiġi limitat l-iskop tal-proċedura ta' referenza attwali għall-armonizzazzjoni tat-twissijiet dwar l-użu prudenti inklużi fis-Sommarju tal-Karatteristiċi tal-Prodott (SPCs) għal dawn il-klassijiet ta' prodott mediċinali veterinarju b'mod konformi ma' dawk rakkomandati fid-dokument tas-CVMP “Karta ta' riflessjoni dwar l-użu ta' fluoroquinolones fl-annimali li jipproduċu l-ikel - Prekawzjonijiet għall-użu flSPC rigward il-gwida għall-użu prudenti (EMEA/CVMP/416168/2006)”.
English: On 28 April 2009, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC, regarding all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species.
Maltese: Fit-28 ta' April 2009, il-Kummissjoni Ewropea ppreżentat lill-Aġenzija notifika ta' referenza skont lArtikolu 35 tad-Direttiva 2001/82/KE, fir-rigward tal-prodotti mediċinali veterinarji kollha li fihom quinolones inklużi fluoroquinolones maħsubin għall-użu fl-ispeċi li jipproduċu l-ikel.
English: referral for all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species
Maltese: għall-prodotti veterinarji mediċinali kollha li fihom quinolones inklużi fluoroquinolones intenzjonati għall-użu fl-ispeċi li jipproduċu l-ikel
English: Written explanations were provided by the applicants/marketing authorisation holders on 18 August 2009.
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti mill-applikanti/detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fit-18 ta' Awwissu 2009.
English: During its meeting of 8-10 December 2009 the CVMP appointed Dr J. Hederová as the rapporteur and Dr J. Bureš as the co-rapporteur for the re-examination procedure.
Maltese: Matul il-laqgħa tiegħu tat-8-10 ta' Diċembru 2009, is-CVMP ħatar lit-tabib J.
English: The CVMP conclusions relating to the specific products that were the focus of the re-examination procedure are reflected in Annex II (Scientific conclusions) of the CVMP opinion.
Maltese: Il-konklużjonijiet tas-CVMP dwar il-prodotti speċifiċi li kienu l-fokus tal-proċedura tal-eżami mill-ġdid huma riflessi fl-Anness II (Konklużjonijiet xjentifiċi) tal-opinjoni tas-CVMP.
English: Based on the rapporteurs' assessment of the available data, the CVMP adopted, on 11 November 2009, an opinion recommending variations of the marketing authorisations for medicinal products containing (fluoro)quinolones intended for food-producing species in order to amend the SPCs and package leaflets in those cases where these were not in line with the prudent use warnings recommended in the CVMP reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance.
Maltese: Fuq il-bażi tal-valutazzjoni tar-rapporteurs tad-dejta disponibbli bħalissa, is-CVMP adotta, fil-11 ta' Novembru 2009, opinjoni li tirrakkomanda varjazzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji li fihom (fluoro)quinolones maħsubin għall-ispeċi li jipproduċu l-ikel sabiex jiġu emendati l-SPCs u l-fuljett ta' tagħrif f'dawk il-każijiet fejn dawn ma kinux konformi mat-twissijiet għall-użu prudenti rakkomandati fil-Karta ta' riflessjoni dwar l-użu ta' fluoroquinolones fl-annimali li jipproduċu l-ikel - Prekawzjonijiet għall-użu fl-SPC rigward il-gwida għall-użu prudenti tas-CVMP.
English: Dose and frequency (1)
Maltese: Doża u frekwenza (1)
English: 30 tablets 100 tablets 200 tablets
Maltese: 30 pilloli 100 pilloli 200 pilloli
English: Liver function test abnormal
Maltese: Test tal-funzjoni talfwied abnormali
English: 2D barcode carrying the unique identifier included.
Maltese: Barcode 2D b'identifikatur uniku inkluż
English: CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73 BSA subject (m2)
Maltese: CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73 BSA pazjent (m2)
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Maltese: Clcr (ml/min) = ------------------------------------------------ (x 0.85 għan-nisa) 72 x livell ta' krejatinina fis-serum (mg/dl)
English: Crospovidon, povidone, silica colloidal anhydrous, magnesium stearate, polyvinyl alcohol-part. hydrolyzed, macrogol 4000, talc, titanium dioxide (E171), colourants*.
Maltese: Crospovidone, povidone, silica colloidal anhydrous, magnesium stearate, polyvinyl acohol part. hydrolyzed, macrogol 4000, talc, titanium dioxide (E171), sustanza li jagħtu l-kulur*.
English: 31-546 Kraków
Maltese: 31-546 Krakow, Il Polonja
English: Silica colloidal anhydrous Magnesium stearate Polyvinyl alcohol - part. hydrolyzed Macrogol 4000
Maltese: Polyvinyl alcohol - part. hydrolyzed Macrogol 4000
English: Date of first authorisation: 03 October 2011 Date of latest renewal:08 September 2016
Maltese: Data tal-aħħar tiġdid: 8 ta' Settembru 2016
English: OTHER
Maltese: II
English: Depression, hostility/ aggression, anxiety, insomnia, nervousness/irritability
Maltese: Depressjoni, ostilita`/ aggressjoni, anzjeta`, insomnja,
English: <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Maltese: (≥1/10,000 sa ≤1/1,000) u rari ħafna: (≤1/10,000).
English: 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).
Maltese: 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).
English: Specifar S.A 1, 28 Octovriou str. 123 51 Ag. Varvara Athens
Maltese: Specifar S.A. 1, 28 Triq Octovriou, 123 51 Ag.
English: The active substance is called levetiracetam.
Maltese: Is-sustanza attiva jisimha levetiracetam.
English: • pancreatitis;
Maltese: pankreatite;
English: In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 AND UGT1A6]) and epoxide hydroxylase activities.
Maltese: In vitro, kemm levetiracetam u kemm il-prodott ewlieni tal-metabolożmu ma fixklux l-iżoformi taċċitokromju P450 fil-fwied ( CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 u 1A2), glucuronyl transferase
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Maltese: impediment talmemorja, koordinazzjoni abnormali/ataxja, paraestesija, disturbi fl-attenzjoni
English: 500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily
Maltese: 500 sa 1,000 mg darbtejn kuljum250 sa 750 mg darbtejn kuljum
English: In a pooled analysis, the percentage of patients who achieved 50 % or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7 %, 31.6 % and 41.3 % for patients on 1,000, 2,000 or 3,000 mg levetiracetam respectively and of 12.6 % for patients on placebo.
Maltese: F'analiżi miġbur, il-perċentaġġ ta' pazjenti li laħqu tnaqqis ta' 50 % jew iżjed milllinja 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 1,000, 2,000, jew 3,000 mg ta' levetiracetam rispettivament u ta' 12.6 % għal pazjenti fuq il-plaċebo.
English: Contains colouring agent sunset yellow (E110).
Maltese: Fih kolorant sunset yellow (E110).
English: 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.
Maltese: 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.
English: Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland
Maltese: Reykjavikurvegur 76-78, 220
English: An oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Maltese: Soluzzjoni orali hija l-formulazzjoni preferita għall-użu fit-trabi u tfal taħt l-età ta' 6 snin.
English: In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study.
Maltese: Barra minn hekk, 101 trabi b'età inqas minn 12-il xahar ġew esposti fi studju tas-sikurezza wara l awtorizzazzjoni.