FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma levels increase linearly with the dose and the pharmacokinetic profile is dose-independent.
Maltese: Illivelli fil-plażma żdiedu linearment skond id-doża, u l-komportament farmakokinetiku kien indipendenti mid-doża wżata.
English: Increased alanine aminotransferase usually appeared within 3 months after the start of therapy with riluzole; they were usually transient and levels returned to below twice the ULN after 2 to 6 months while treatment was continued.
Maltese: Żieda fil-livell ta' alanine aminotransferase normalment tfaċċat fi żmien 3 xhur mill-bidu tat-terapija b'riluzole; dawn normalment għaddew u l-livelli ġew anqas minn darbtejn il-ULN wara perijodu ta' minn 2 sa 6 xhur, waqt li tkompliet il-kura.
English: In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section
Maltese: Minn studji kliniċi, f'pazjenti (n=20) fejn kien hemm żidiet fil-ALT għal iżjed minn 5 darbiet il-ULN, ittrattament ġie mwaqqaf u f'ħafna drabi l-livelli ġew anqas minn darbtejn il-ULN f'perjodu ta' 2 sa 4 xhur (ara sezzjoni 4.4).
English: In a dose-ranging trial, 959 patients with ALS were randomised to one of four treatment groups: riluzole 50, 100, 200 mg/day, or placebo and were followed-up for 18 months.
Maltese: Fi prova fejn kienet investigata l-firxa tad-dożaġġi, 959 pazjent bl-ALS tqassmu, mingħajr għażla, f'wieħed minn erba' gruppi ta' kura: riluzole 50, 100, 200 mg/jum, jew plaċebo u kienu segwiti għal 18-il xahar.
English: If you are less than 18 years of age, the use of RILUTEK is not recommended because there is no information available in this population.
Maltese: Jekk inti għandek inqas minn 18-il sena, l-użu ta' RILUTEK m'huwiex rakkomandat minħabba li m'hemmx informazzjoni disponibbli f'din il-popolazzjoni.
English: Very common side effects (may affect more than 1 in 10 people) of RILUTEK are: tiredness feeling sick increased blood levels of some enzymes of the liver (transaminases).
Maltese: Effetti sekondarji mhux komuni (jistgħu jolqtu sa persuna 1 minn kull 100) ta' RILUTEK huma: - anemija - reazzjonijiet allerġiċi - infjammazzjoni tal-frixa (pankreatite)
English: Common side effects (may affect up to 1 in 10 people) of RILUTEK are: dizziness numbness or tingling of the mouth vomiting sleepiness increase in heart beat diarrhoea headache abdominal pain pain
Maltese: Effetti sekondarji komuni (jistgħu jolqtu sa persuna 1 minn kull 10 ) ta' RILUTEK huma: sturdament ħalq imtarrax jew mnemnem rimettar ngħas żieda fit-tħabbit tal-qalb dijarrea uġigħ ta' ras uġigħ addominali uġigħ
English: Warnings and precautions Talk to your doctor before taking RILUTEK: if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick if your kidneys are not working very well if you have any fever: it may be due to a low number of white blood cells which can cause an increased risk of infection If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.
Maltese: M'hemm l-ebda evidenza li RILUTEK jeżerċita effett terapewtiku fuq il-movimenti tal-persuna, ilfunzjoni tal-pulmuni, kontrazzjonijiet involontarji tal-muskoli, s-saħħa tal-muskoli jew sintomi riferibbli għall-moviment. RILUTEK ma ntweriex li kien effettiv fi stadji avanzati ta' ALS.
English: Film-coated tablet
Maltese: Fil-qalba tal-pillola:
English: B. PACKAGE LEAFLET
Maltese: MANIFATTUR(I) RISPONSABBLI
English: EU/1/96/010/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/010/001
English: Liver impairment
Maltese: Bijotrasformazzjoni
English: Clinical trials have demonstrated that RILUTEK extends survival for patients with ALS (see section 5.1).
Maltese: Studji kliniċi wrew li RILUTEK itawwal il-ħajja ta' pazjenti bl-ALS (ara sezzjoni 5.1).
English: RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS).
Maltese: RILUTEK jintuża f'pazjenti bl-atrofija tal-muskoli dovuta għall-isklerożi laterali (ALS).
English: RILUTEK 50 mg film-coated tablets Riluzole
Maltese: IL-PRODOTT MEDIĊINALI RILUTEK 50 mg pilloli miksija b'rita
English: NAME OF THE MEDICINAL PRODUCT RILUTEK 50 mg film-coated tablets riluzole
Maltese: TAL-PRODOTT MEDIĊINALI RILUTEK 50 mg pilloli miksija b'rita riluzole ISEM
English: The median survival time approached 16.5 months versus 13.5 months for riluzole 100 mg/day and placebo, respectively.
Maltese: Iż-żmien medjan ta' sopravivenza laħaq is-16.5 xhur kontra it13.5 xhur, għal riluzole 100 mg/jum u l-paċebo, rispettivament.
English: In vitro studies using human liver microsomal preparations suggest that CYP 1A2 is the principal isozyme involved in the initial oxidative metabolism of riluzole.
Maltese: Studji in vitro, fejn intużaw preparati ta' mikrożomi mill-fwied tal-bniedem, jindikaw li l-CYP 1A2 hija l-iżożima prinċipali involuta fil-metaboliżmu ossidattiv inizjali ta' riluzole.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ALUMINIUM BLISTER
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Pilloli ppakkjati fi strixxi ta' folji opaki tal-pvc/aluminju.
English: Renal impairment Studies at repeated doses have not been conducted in patients with impaired renal function (see section
Maltese: Indeboliment renali Studji b'dożi repetuti ma sarux f'pazjenti b'indeboliment fil-funzjoni renali (ara sezzjoni 4.2).
English: In a double-blind placebo-controlled trial designed to assess the efficacy and safety of riluzole in Japanese patients, 204 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 18 months.
Maltese: Fi studji ikkontrollati permezz tal-plaċebo, tat-tip double-blind, li sar biex jassessja l-effikaċja u ssigurtà ta' riluzole f'pazjenti Ġappuniżi, 204 pazjent kienu mqassmin, mingħajr għażla, biex jieħdu jew riluzole 100 mg/jum (50 mg darbtejn kuljum) jew il-plaċebo, u dawn kienu segwiti għal 18-il xahar.
English: There have been no clinical studies to evaluate the interactions of riluzole with other medicinal products.
Maltese: Ma sarux studji kliniċi biex jevalwaw l-interazzjonijiet ta' riluzole ma' prodotti mediċinali oħra.
English: Coating:
Maltese: Sími:
English: RILUTEK is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4).
Maltese: RILUTEK mhux irrakkomandat f'pazjenti li għandhom indeboliment renali, peress li qatt ma saru studji b'dożi repetuti f'dawn il-pazjenti (ara sezzjoni 4.4).
English: Pregnancy, breast-feeding and fertility
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: Method of administration Oral use
Maltese: Mhux applikabbli
English: Member State EU/EEA
Maltese: Stat Membru (UE/ŻEE)
English: Fasting Point estimate (%) for test / reference (90% CI)
Maltese: Stima lokali (%) għat-test / referenza (90% CI)
English: 25 mg capsule
Maltese: 25 mg kapsula
English: -The safety profile of ciclosporin is also critical.
Maltese: - Il-profil tas-sigurtà ta' ciclosporin huwa kritiku wkoll.
English: The MAH quoted a publication from The National Kidney Foundation of 1999 raising inequivalence concerns for transplant organ immunosuppressants and introduced the term “critical-dose drug”.
Maltese: Il-MAH ikkwota pubblikazzjoni minn The National Kidney Foundation (Fondazzjoni Nazzjonali talKliewi) tal-1999 li tqajjem tħassib dwar in-nuqqas ta' ekwivalenza għall-immunosoppressivi għattrapjant tal-organi u introduċiet it-terminu “mediċina ta' doża kritika” (critical-dose drug).
English: Benefit/risk assessment
Maltese: Valutazzjoni tal-benefiċċji/riskji
English: drug.
Maltese: NTI.
English: Ciclosporin is indicated in transplantation (e.g. prevention or treatment of rejection of solid organ transplantation, bone marrow transplantation, graft-versus-host-disease) and auto-immune diseases (e.g nephrotic syndrome, rheumatoid arthritis, psoriasis, atopic dermatitis).
Maltese: Ciclosporin huwa inibitur ta' calcineurin u bħala tali huwa mediċina immunosoppressiva. Ciclosporin huwa indikat fit-trapjanti (pereżempju il-prevenzjoni jew it-trattament ta' rifjut ta' trapjant ta' organi solidi, it-trapjant tal-mudullun, il-marda graft-versus-host) u l-mard awto-immuni (pereżempju ssindrome nefrotiku, l-artrite rewmatojde, il-psorjażi, id-dermatite atopika).
English: The SPC for Sandimmun Optoral allows administration regardless of food, indicating that the known food effect for ciclosporin (approximately 26% reduction of Cmax and 15% reduction of AUC) is considered not clinically relevant.
Maltese: L-SPC għal Sandimmun Optoral jippermetti l-amministrazzjoni irrispettivament mill-ikel, li jindika li l-effett tal-ikel magħruf għal ciclosporin (tnaqqis ta' madwar 26% ta' Cmax u tnaqqis ta' 15% ta' AUC) huwa meqjus bħala mhux klinikament rilevanti.
English: The Reference medicinal product authorised in Germany is: Sandimmun Optoral 25 mg Kapseln.
Maltese: Il-prodott mediċinali ta' Referenza awtorizzat fil-Ġermanja huwa: Sandimmun Optoral 25 mg Kapseln.
English: The MAH answered that there doesn't seem to be a convincing reason why the range (80-125%) should be different for Cmax and AUC.
Maltese: Il-MAH wieġeb li ma jidhirx li hemm raġuni konvinċenti għaliex il-firxa (80-125%) għandha tkun differenti għal Cmax u AUC.
English: Variable
Maltese: Varjabbli
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Maltese: TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, APPLIKANTI / DETENTURI TALAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: The MAH divided its argumentation into 2 parts: bioequivalence and safe switch, and pharmaceutical properties of Sandimmune Optoral and Ciclosporin IDL micro emulsions
Maltese: Il-MAH qasam l-argumentazzjoni tiegħu f'2 partijiet: il-bijoekwivalenza u l-bidla sigura, u lkaratteristiċi farmaċewtiċi tal-mikro emulsjonijiet ta' Sandimmune Optoral u Ciclosporin IDL
English: In view of the MAH, from the data generated by the bioequivalence studies, the ciclosporin test product is in the range 90%-111% for the AUC and less than 111% of the reference for the Cmax in the fasted conditions study which reflects the pharmacokinetic parameters without any interaction.
Maltese: Fl-opinjoni tal-MAH, mid-dejta ġġenerata mill-istudji ta' bijoekwivalenza, il-prodott ta' prova ta' ciclosporin huwa fil-firxa ta' 90%-111% għall-AUC u inqas minn 111% tar-referenza għas-Cmax flistudju taħt kundizzjonijiet ta' sawm li jirrifletti l-parametri farmakokinetiċi mingħajr l-ebda interazzjoni.
English: The CHMP addressed a list of questions to the Marketing Authorisation Holder and to the Efficacy Working Party PK expert group for consultation on the following points:
Maltese: Is-CHMP indirizza lista ta' mistoqsijiet lill-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u lillgrupp ta' esperti PK għall-Ħidma dwar l-Effikaċja (Efficacy Working Party) għall-konsultazzjoni dwar il-punti li ġejjin:
English: Pharmaceutical properties of Sandimmune Optoral and Ciclosporin IDL micro emulsions
Maltese: Karatteristiċi farmaċewtiċi ta' mikro emulsjonijiet ta' Sandimmune Optoral u Ciclosporin IDL
English: In the MRP procedure (NL/H/1402/001-003/MR) potential serious risk for public health concern was raised on the following grounds: bioequivalence has not been sufficiently demonstrated.
Maltese: Fil-proċedura MRP (NL/H/1402/001-003/MR) it-tħassib ta' riskju potenzjali serju għas-saħħa pubblika tqajjem minħabba r-raġunijiet li ġejjin: il-bijoekwivalenza ma ntweritx biżżejjed.
English: Thus the CHMP retains its opinion and assessment report dated 23 April 2009 that the bioequivalence to the originator has not been shown and the benefit/risk ratio of Ciclosporin IDL is considered to be negative.
Maltese: Għalhekk is-CHMP iżomm l-opinjoni u r-rapport ta' valutazzjoni datat it-23 ta' April 2009 tiegħu li lbijoekwivalenza mal-oriġinatur ma ntwerietx u l-proporzjon tal-benefiċċji/riskji ta' Ciclosporin IDL huwa meqjus bħala negattiv.
English: RE-EXAMINATION OF THE CHMP OPINION ADOPTED ON 23 APRIL 2009
Maltese: FIT23 TA' APRIL 2009
English: Taking this into account, the question was whether a reduced effect of food on generic ciclosporin pharmacokinetics could be considered acceptable for a ‘generic application', even in case that this results in a failure to comply with the predefined acceptance criteria (e.g. 80-125%) for concluding bioequivalence under fed conditions (in this case with a 90% CI for Cmax of 1.09-1.37).
Maltese: Filwaqt tqies dan kollu, il-kwistjoni kienet jekk effett imnaqqas tal-ikel fuq il-farmakokinetiċi ta' ciclosporin ġeneriku jistax jiġu kkunsidrat aċċettabbli għal ‘applikazzjoni ġenerika', anki fil-każ li dan jirriżulta f'nuqqas ta' konformità malkriterji ta' aċċettazzjoni predefiniti (pereżempju 80-125%) għall-konklużjoni tal-bijoekwivalenza f'kundizzjonijiet ta' tmigħ (f'dan il-każ b'IF ta' 90% għal Cmax ta' 1.09-1.37).
English: For ciclosporin IDL, it was argued that because the differences observed between test and reference products under fed conditions were not due to the test product, but to the very profound effect of food on the blood levels of the reference product, no safety concern arose and the upper 90% confidence limit for comparison of Cmax (137%) was acceptable (see 4 below).
Maltese: Għal ciclosporin IDL, ġie argumentat li minħabba li d-differenzi osservati bejn il-prodotti ta' prova u ta' referenza taħt kundizzjonijiet ta' tmigħ ma kinux dovuti għall-prodott ta' prova, iżda għall-effett profond ħafna tal-ikel fuq il-livelli fiddemm tal-prodott ta' referenza, ma tqajjem l-ebda tħassib għas-sigurtà u l-ogħla limitu ta' fiduċja ta' 90% għat-tqabbil ta' Cmax (137%) kien aċċettabbli (ara 4 hawn taħt).
English: The CHMP adopted a final negative opinion recommending the refusal of the Marketing Authorisation in the Concerned Member States and the suspension of the Marketing Authorisation where the product is currently authorised.
Maltese: Is-CHMP adotta opinjoni negattiva finali li tirrakkomanda r-rifjut tal-Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Istati Membri Kkonċernati u s-sospensjoni tal-Awtorizzazzjoni għat-Tqegħid fis-Suq fejn ilprodott huwa awtorizzat bħalissa.
English: In the ‘fasting' bioequivalence trial presented, the 90% confidence interval for Cmax does not meet the tighter 90-111% acceptance criteria.
Maltese: Fil-prova ta' bijoekwivalenza bis-‘sawm' ippreżentata, l-intervall tal-fiduċja 90% għal Cmax ma jissodisfax il-kriterji ta' aċċettazzjoni aktar stretti ta' 90-111%.
English: In the case of Ciclosporin IDL, the MAH argued that bioequivalence has been proven in the fasting state in CI (80-125%).
Maltese: Fil-każ ta' Ciclosporin IDL, il-MAH sahaq illi l-bijoekwivalenza ġiet ippruvata fl-istat ta' sawm fl-IF (80-125%).
English: Ciclosporin is considered a ‘critical dose drug' with narrow therapeutic index.
Maltese: Ciclosporin huwa kkunsidrat bħala ‘mediċina ta' doża kritika' b'indiċi terapewtiku dejjaq.
English: The data submitted showed that the 90% CI for Cmax fell outside the standard (80-125%) acceptance range in the fed state and outside a narrowed (90-111%) acceptance range in the fasted state and the respective value for AUC exceeds the narrowed acceptance range in the fed state.
Maltese: Id-dejta sottomessa uriet li l-IF ta' 90% għal Cmax kien barra mill-firxa ta' aċċettazzjoni rikonoxxuta (80-125%) fl-istat mitmugħ u barra firxa ta' aċċettazzjoni idjaq (90-111%) fl-istat ta' sawm u l-valur rispettiv għal AUC jaqbeż il-firxa ta' aċċettazzjoni idjaq fl-istat mitmugħ.
English: In the MAH view even if Ciclosporin was to be considered a NTI drug, the normal 80-125% acceptance range should be used.
Maltese: Fil-fehma tal-MAH anki jekk Ciclosporin kellu jiġi meqjus bħala mediċina NTI, għandha tintuża lfirxa ta' aċċettazzjoni normali ta' 80-125%.
English: - the Scope of the Referral was about the bioequivalence (BE) of the generic Ciclosporin IDL to the originator.
Maltese: - l-Ambitu ta' Referenza kien dwar il-bijoekwivalenza (BE) ta' Ciclosporin IDL ġeneriku maloriġinatur.
English: 1) The first issue raised by the CHMP was whether a normal (80-125%) or narrowed (90-111%) acceptance range should be applied for assessing bioequivalence under fasting conditions, considering ciclosporin is to be regarded a 'highly variable drug' with a Narrow Therapeutic Range.
Maltese: 1) L-ewwel kwistjoni mqajma mis-CHMP kienet jekk għandhiex tiġi applikata firxa ta' aċċettazzjoni normali (80-125%) jew imdejqa (90-111%) għall-evalwazzjoni tal-bijoekwivalenza taħt kundizzjonijiet ta' sawm, meta jitqies li ciclosporin għandu jiġi kkunsidrat bħala ‘mediċina varjabbli ħafna' b'Firxa Terapewtika Dejqa.
English: There is emerging data indeed to suggest that appropriate therapeutic monitoring may radically reduce the incidence of acute rejection in de-novo recipients and ameliorate chronic rejection and secondary effects in maintenance transplant patients, as for ciclosporin, the patients inter and intra-variability is actually more problematic than the therapeutic index.
Maltese: Huwa minnu li hemm dejta emerġenti li tissuġġerixxi li monitoraġġ terapewtiku xieraq jista' jnaqqas radikalment l-inċidenza ta' rifjut akut fir-reċipjenti de-novo u jtejjeb rifjut kroniku u effetti sekondarji f'pazjenti ta' trapjant ta' manutenzjoni, bħal fil-każ ta' ciclosporin, l-inter u intra-varjabilità talpazjenti hija fil-fatt aktar problematika mill-indiċi terapewtiku.
English: This may result in major swings in blood concentrations, since it has been shown that the intake of food has a very negative effect on absorption (up to about 30% reduction of Cmax and 15% reduction in AUC) of the reference product.
Maltese: Dan jista' jwassal għal varjazzjonijiet kbar filkonċentrazzjonijiet tad-demm, minħabba li ntwera li t-teħid tal-ikel għandu effett negattiv ħafna fuq lassorbiment (sa madwar tnaqqis ta' 30% ta' Cmax u tnaqqis ta' 15% fl-AUC) tal-prodott ta' referenza.
English: The MAH summarized previous studies showing that the size of the emulsion droplets and concomitant food intake have an effect on the absorption of ciclosporin from the small intestine when orally administered, which may have an influence on the drugs' pharmacokinetic parameters The MAH compared Neoral and 3 batches of Ciclosporin IDL.
Maltese: Il-MAH ġabar fil-qosor studji preċedenti li juru li d-daqs tal-qtar tal-emulsjoni u teħid konkomittanti tal-ikel għandhom effett fuq l-assorbiment ta' ciclosporin mill-musrana ż-żgħira meta jingħata b'mod orali, li jista' jkollu influwenza fuq il-parametri farmakokinetiċi tal-mediċini.
English: The CHMP agreed with the EWP PK expert group position that if ciclosporin is considered a narrow therapeutic index drug, a narrowed (90-111%) acceptance range should be applied for AUC.
Maltese: Is-CHMP qabel mal-pożizzjoni tal-grupp ta' esperti EWP PK li jekk ciclosporin jitqies bħala mediċina b'indiċi terapewtiku dejjaq, għandha tiġi applikata firxa ta' aċċettazzjoni mdejqa (90-111%) għall-AUC.
English: The upper 90% interval confidence limit for Cmax, which should be considered for safety issues, is below the accepted limit (111%) for NTI products.
Maltese: Il-limitu massimu tal-intervall ta' fiduċja ta' 90% għal Cmax, li għandu jiġu kkunsidrat għall-kwistjonijiet ta' sigurtà, huwa taħt il-limitu aċċettat, (111%) għall-prodotti NTI.
English: ANNEX III CONDITION FOR THE LIFTING OF THE MARKETING AUTHORISATIONS SUSPENSION
Maltese: ANNESS III KUNDIZZJONIJIET GĦAT-TNEĦĦIJA TAS-SOSPENSJONI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: The evidence for bioequivalence, which meets narrow (90-111%) acceptance criteria for AUC under fasting conditions, meets standard (80-125%) acceptance criteria for Cmax in the fasted state, and fails to meet even standard acceptance criteria the fed state, is regarded as inadequate to support a conclusion of bioequivalence.
Maltese: L-evidenza għall-bijoekwivalenza, li tissodisfa l-kriterji ta' aċċettazzjoni dojoq (90-111%) għal AUC taħt kundizzjonijiet ta' sawm, tissodisfa l-kriterji ta' aċċettazzjoni standard (80-125%) għal Cmax fl-istat sajjem, u tonqos milli jissodisfa anke l-kriterji ta' aċċettazzjoni standard fl-istat ta' tmigħ, hija kkunsidrata bħala mhux xierqa sabiex tappoġġa konklużjoni ta' bijoekwivalenza.
English: Marketing Authorisation Holder
Maltese: ANNESS I LISTA
English: The CHMP considered that as ciclosporin is NTI drug, narrowing the Confidence Interval (CI) range to 90-111%, would minimize the risk of over or under exposure.
Maltese: Is-CHMP ikkunsidra li minħabba li ciclosporin huwa mediċina NTI, it-tidjiq tal-firxa tal-Intervall ta' Fiduċja (IF) sa 90-111%, jimminimizza r-riskju ta' espożizzjoni żejda jew nieqsa.
English: It is essential the therapeutic monitoring of renal, liver functions and blood pressure as adverse events are reported as very common and in a transplant population can be clinically devastating.
Maltese: Huwa essenzjali li l-monitoraġġ terapewtiku tal-funzjonijiet tal-kliewi u tal-fwied u l-pressjoni tad-demm bħala avvenimenti avversi jiġu rrappurtati bħala komuni ħafna u f'popolazzjoni tat-trapjanti jistgħu jkunu klinikament devastanti.
English: Ciclosporin IDL 100 mg 100 mg capsule, soft
Maltese: Ciclosporin IDL 100 mg 100 mg kapsula, ratba
English: The Efficacy Working Party PK expert group, consulted by the CHMP, understood that in clinical practice, ciclosporin is often recommended to be taken in a standardised way in relation to food.
Maltese: Il-grupp ta' esperti PK għall-Ħidma dwar l-Effikaċja, ikkonsultat mis-CHMP, fehem li fil-prattika klinika, huwa ta' spiss rakkomandat li ciclosporin jittieħed b'mod standardizzat fir-rigward tal-ikel.
English: The CHMP considered that the size of the particles is not a relevant argument for accepting wider bioequivalence range for ciclosporin.
Maltese: Is-CHMP ikkunsidra li d-daqs tal-partikoli mhuwiex argument rilevanti għall-aċċettazzjoni ta' firxa usa ta' bijoekwivalenza għal ciclosporin.
English: Ciclosporin IDL 50 mg 50 mg capsule, soft
Maltese: Ciclosporin IDL 50 mg 50 mg kapsula, ratba
English: In addition, in the Transplant Patient Guide (University of Southern California-Cardiothoracic Surgery and Pancreas Transplant Program), it is recommended to take ciclosporin before meals, for better absorption by the stomach.
Maltese: Barra minn hekk, fil-Gwida għallPazjenti ta' Trapjant (Università tan-Nofisinhar ta' Kalifornja-Programm tal-Kirurġija Kardjotoraċika u tat-Trapjant tal-Frixa), huwa rakkomandat li ciclosporin jittieħed qabel l-ikel, għal assorbiment aħjar mill-istonku.
English: Ciclosporina IDL 100 mg 100 mg capsule
Maltese: FRANZA Ciclosporin IDL 100 mg100 mg kapsula
English: Ciclosporin IDL 25 mg 25 mg capsule, soft
Maltese: Ciclosporin IDL 25 mg 25 mg kapsula, ratba
English: The MAH answered that ciclosporin, in spite of being highly variable drug, is not to be considered a Narrow Therapeutic Index (NTI) drug because the clinical evidence for such a classification is lacking.
Maltese: Il-MAH wieġeb li ciclosporin, minkejja li huwa mediċina varjabbli ħafna, m'għandux jiġi kkunsidrat bħala mediċina b'Indiċi Terapewtiku Dejjaq (Narrow Therapeutic Index - NTI) minħabba li levidenza klinika għal tali klassifikazzjoni hija nieqsa.
English: The CHMP concluded that bioequivalence has not been satisfactorily demonstrated, the benefit/risk ratio is considered negative and Ciclosporin IDL cannot be recommended for approval.
Maltese: Is-CHMP ikkonkluda li, l-bijoekwivalenza ma ntwerietx b'mod sodisfaċenti, il- proporzjon talbenefiċċji/riskji huwa meqjus bħala negattiv u Ciclosporin IDL ma jistax jiġi rrakkomandat għal approvazzjoni.
English: The Marketing Authorisation Holder should conduct a new fasting and fed bioequivalence study showing the bioequivalence of Ciclosporin IDL under a tightened acceptance range (90-111%) for the 90% CI.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jagħmel studju ta' bijoekwivalenza ġdid f'kundizzjonijiet ta' stonku vojt u stonku mimli li juri l-bijoekwivalenza ta' Ciclosporin IDL taħt medda ta' aċċettazzjoni ristretta (90-111%) għas-CI ta' 90%.