FrancophonIA/ELRC3.0 huggingface dataset:
English: Pantoprazole is also known to exhibit delayed absorption and increased pharmacokinetic variability when taken with food in some individuals, though the extent of absorption [AUC] is generally considered not to be affected (Radhofer-Welte, 1999, and Fitton and Wiseman and 1996 Andersson).
Maltese: Pantoprazole huwa magħruf ukoll li jesebixxi assorbiment imdewwem u żieda fil-varjabbiltà farmakokinetika meta jittieħed mal-ikel f'xi individwi, għalkemm il-firxa tal-assorbiment [AUC] hija meqjusa ġeneralment bħala li mhijiex affettwata (Radhofer-Welte, 1999, u Fitton u Wiseman u 1996 Andersson).
English: The CHMP considered that the drug intake after breakfast (30 minutes) was sufficiently short.
Maltese: Is-CHMP qies li t-teħid tal-mediċina wara l-kolazzjon (30 minuta) kien qasir biżżejjed.
English: The wider acceptance interval (75-133 %) for bioequivalence is considered justified, since pantoprazole is found to be highly variable under fed conditions.
Maltese: L-intervall ta' aċċettazzjoni usa' (75-133 %) għallbijoekwivalenza huwa kkunsidrat iġġustifikat, minħabba li pantoprazole jinstab li huwa varjabbli ħafna taħt kundizzjonijiet wara ikla.
English: Because different batches were used in the previous bioequivalence studies and in the confirmatory one, the Applicant presented comparative dissolution studies at pH 6 and 6.8 for these different batches.
Maltese: Minħabba li ntużaw lottijiet differenti fl-istudji ta' bijoekwivalenza preċedenti u f'dak konfermatorju, lApplikant ippreżenta studji ta' dissoluzzjoni komparattivi f'pH 6 u 6.8 għal dawn il-lottijiet differenti.
English: LoOI - Q3: The Applicant was requested to submit additional PK evaluations for test and reference product for the new bioequivalence study as the Lag-times and the % extrapolated AUC.
Maltese: LoOI - Q3: L-Applikant intalab jissottometti evalwazzjonijiet PK addizzjonali għall-prodott tat-test u għallprodott ta' referenza għall-istudju ta' bijoekwivalenza l-ġdid bħala l-ħinijiet ta' Lag u l-% ta' AUC estrapolat.
English: The Applicant pointed out that in defined situations, as for pantoprazole, wider interval (75-133 %) for Cmax may be acceptable “if justified, addressing in particular any safety or efficacy concerns for patients switched between formulations”.
Maltese: LApplikant indika li f'sitwazzjonijiet definiti, bħal fil-każ ta' pantoprazole, intervall usa' (75-133%) għal Cmax jista' jkun aċċettabbli “jekk iġġustifikat, li jindirizza b'mod partikolari kwalunkwe tħassib tas-sigurtà u leffikaċja għal pazjenti li jinqelbu bejn formolazzjoni u oħra”.
English: The Applicant committed to update the Summary of Product Characteristics and Package Leaflet in accordance to the outcome of the ongoing SPC harmonisation procedure under Article 30 of Directive 2001/83/EC with the reference product Protium and associated names.
Maltese: L-Applikant impennja ruħu li jaġġorna s-Sommarju tal-Karatteristiċi tal-Prodott u l-Fuljett ta' Tagħrif skont irriżultat tal-proċedura ta' armonizzazzjoni tal-SPC li ma tieqafx skont l-Artikolu 30 tad-Direttiva 2001/83/KE bilprodott ta' referenza Protium u ismijiet assoċjati.
English: The Reference Member State (RMS) for the decentralised procedure for Pantoprazole Bluefish application was Sweden and the Concerned Member States (CMS) were: Austria, Germany, Denmark, Spain, Finland, France, Hungary, Ireland, Italy, The Netherlands, Norway, Poland and Portugal.
Maltese: L-Istat Membru ta' Referenza (RMS) għall-proċedura deċentralizzata għal applikazzjoni ta' Pantoprazole Bluefish kien ir-Renju Unit u l-Istati Membri Kkonċernati (CMS) kienu: ir-Repubblika Ċeka, il-Ġermanja, ilPolonja u r-Repubblika Slovakka.
English: The CHMP, in the adopted List of Questions, requested the Applicant to discuss the design and results of the fed bioequivalence study, in the following key aspects: (i) The justification for the design of the study, particularly the 15 h sampling schedule and the rationale for pre-defining outliers based on the well-characterised and anticipated delayed absorption of pantoprazole with food in a small proportion of subjects - this should be discussed with reference to the current guidelines and in terms of the ability of the evaluable data to exclude a formulation difference under fed conditions.
Maltese: Il-ġustifikazzjoni għad-disinn tal-istudju, b'mod partikolari l-iskeda ta' teħid ta' kampjuni ta' 15-il siegħa u liskeda għal dawk li ma jikkonformawx pre-definiti, ibbażata fuq l-assorbiment imdewwem ikkaratterizzat sewwa u mistenni ta' pantoprazole mal-ikel fi proporzjon żgħir ta' suġġetti - dan għandu jiġi diskuss b'referenza għal-linji gwida attwali u fit-termini tal-abbiltà tad-dejta evalwabbli sabiex tiġi eskluża differenza filformolazzjoni taħt kundizzjonijiet wara ikla.
English: • The rate of outlying cases from the test formulation must be no greater than the reference + 20 %
Maltese: • Ir-rata tal-każijiet li ma jikkonformawx mal-formolazzjoni tat-test ma għandhiex tkun ikbar mir-referenza +
English: Furthermore, the in vitro gastro-resistance and in vitro dissolution data presented and discussed in this response support bioequivalence conclusion.
Maltese: Barra minn hekk, id-dejta dwar il-gastro-reżistenza in vitro u dwar ix-xoljiment in vitro ppreżentata u diskussa f'dan ir-rispons tappoġġja konklużjoni ta' bijoekwivalenza.
English: The Applicant presented several literature references to justify the PK variability of pantoprazole.
Maltese: L-Applikant ippreżenta bosta referenzi tal-litteratura sabiex jiġġustifika l-varjabbiltà tal-PK ta' pantoprazole.
English: The Applicant considered that the design of both of these bioequivalence studies took into account the requirements of the current bioequivalence guidelines (CPMP/EWP/QWP/1401/98), the known pharmacokinetic characteristics of pantoprazole, and the stated administration instructions as detailed in the SmPC (“swallow whole with water before a meal”).
Maltese: L-Applikant qies li d-disinn ta' dawn iż-żewġ studji ta' bijoekwivalenza kkunsidra r-rekwiżiti tal-linji gwida ta' bijoekwivalenza attwali (CPMP/EWP/QWP/1401/98), il-karatteristiċi farmakokinetiċi magħrufin ta' pantoprazole, u l-istruzzjonijiet ta' amministrazzjoni mogħtija kif dettaljati fl-SmPC (“ibla' sħiħ mal-ilma qabel ikla”).
English: A period of 15 hours was consequently deemed to be suitable for quantification of at least 80 % of the total AUC, as recommended in the guidelines.
Maltese: Konsegwentament, perjodu ta' 15-il siegħa tqies li jkun xieraq għall-kwantifikazzjoni ta' mill-inqas 80% tal-AUC totali, kif rakkomandat fil-linji gwida.
English: In this study, the AUC met the required acceptance interval for bioequivalence (80-125).
Maltese: F'dan l-istudju, l-AUC laħaq l-intervall ta' aċċettazzjoni meħtieġ għall-bijoekwivalenza (80-125).
English: These studies were: cross-over, openlabel, randomised treatment sequence bioequivalence studies carried out in healthy volunteers; they took into account the current guidelines and the pharmacological characteristics of pantoprazole, the prolonged T-max, the increased variability (especially Cmax), and the unaltered half-life under fed conditions.
Maltese: Dawn l-istudji kienu: studji cross-over, studji bit-tiketta mikxufa, studji ta' bijoekwivalenza ta' sekwenza ta' trattament randomizzati mwettqa f'voluntiera b'saħħithom; qiesu l-linji gwida attwali u l-karatteristiċi farmakoloġiċi ta' pantoprazole, itT-max imtawwal, il-varjabbiltà miżjuda (b'mod speċjali Cmax), u l-half-life mhux mibdul taħt kundizzjonijiet wara ikla.
English: Usual in- and exclusion criteria for studies in healthy volunteers were applied in order to exclude subjects with relevant illness.
Maltese: Ġew applikati kriterji normali ta' approvazzjoni u esklużjoni għall-istudji f'voluntiera b'saħħithom sabiex jiġu esklużi suġġetti b'mard relevanti.
English: The CHMP, considering the data reported, concluded that there was no formulation difference of any clinical significance.
Maltese: Is-CHMP, waqt li kkunsidra d-dejta rrappurtata, ikkonkluda li ma kien hemm l-ebda differenza ta' formulazzjoni ta' xi sinifikat kliniku.
English: Standard criteria for bioequivalence were used i.e. the 90 % CI for the AUC and Cmax ratios must lie within the accepted range of 80.00-125.00.
Maltese: Intużaw kriterji standard għall-bijoekwivalenza, jiġifieri s-CI ta' 90% għall-proporzjonijiet tal-AUC u tas-Cmax għandhom ikunu fi ħdan il-medda aċċettata ta' 80.
English: During the DCP a CMS raised major objections concerning the bioequivalence with the originator under fed conditions.
Maltese: Matul DCP, CMS qajmu objezzjonijiet maġġuri fir-rigward tal-bijoekwivalenza mal-oriġinatur taħt kundizzjonijiet wara ikla.
English: The Applicant determined the sampling schedule in the study undertaken taking into account the general information from the available published references which in general supported a gastric emptying time range of less than 1 hour to approximately 5 hours where varying intakes of food were involved.
Maltese: L-Applikant stabbilixxa l-iskeda ta' teħid ta' kampjuni fl-istudju mwettaq filwaqt li qies l-informazzjoni ġenerali mir-referenzi ppubblikati disponibbli li b'mod ġenerali kienu jappoġġjaw medda ta' ħin ta' tbattil gastriku ta' inqas minn siegħa għal madwar 5 sigħat fejn kien involut teħid li jvarja tal-ikel.
English: et al. (1991) food may delay gastric emptying up to 10-11 hours and thus can influence the timing of the absorption of orally administered drugs.
Maltese: (1991) l-ikel jista' jdewwem it-tbattil gastriku sa 10-11-il siegħa u b'hekk jista' jinfluwenza l-ħin tal-assorbiment ta' mediċini li jingħataw oralment.
English: The CHMP concluded that both formulations are equivalent and are therapeutically equivalent and that there is no risk to the clinical management of the patients.
Maltese: Is-CHMP ikkonkluda li ż-żewġ formolazzjonijiet huma ekwivalenti u huma terapewtikament ekwivalenti u li ma hemm ebda riskju għall-ġestjoni klinika tal-pazjenti.
English: Pharmaceutical Form Route of administration
Maltese: Pillola gastro-reżistenti
English: The CHMP noted that the difference in the Cmax between the test and the originator has no clinical significance.
Maltese: Is-CHMP innota li d-differenza fis-Cmax bejn it-test u l-oriġinatur ma kellha ebda sinifikat kliniku.
English: • A case will be considered to be an outlier if at least one of the following conditions apply: - There is complete or almost complete lack of absorption of the drug (AUClast is less than 10 % of the mean values of the corresponding formulation) - If T-max is >12 h
Maltese: • Każ jitqies li jkun ma jikkonformax, jekk tkun tapplika għallinqas kundizzjoni waħda minn dawn li ġejjin - Hemm nuqqas ta' assorbiment sħiħ jew kważi sħiħ tal-mediċina (AUClast hija inqas minn 10% tal-valuri medji tal-formolazzjoni korrespondenti) - Jekk T-max huwa >12 h
English: This kinetic alteration appears frequently with pantoprazole and is the basis as to why the Summary of Product Characteristics for Pantoprazole products in the EU state: ‘Swallow whole with water before a meal'.
Maltese: Dan it-tibdil kinetiku jidher frekwenti ma' pantoprazole u huwa l-bażi l-għala s-Sommarju tal-Karatteristiċi talProdott għal prodotti ta' Pantoprazole fl-UE jiddikjara: ‘Ibla' sħiħ mal-ilma qabel ikla'.
English: Strength
Maltese: Studji
English: The European Guidelines lay down the criteria for the design of bioavailability and bioequivalence studies (CPMP/EWP/QWP/1401/98).
Maltese: Il-Linji Gwida Ewropej jistabbilixxu l-kriterji għad-disinn tal-istudji tal-bijodisponibbiltà u tal-bijoekwivalenza (CPMP/EWP/QWP/1401/98).
English: The parameters determined, methods used for analysis, and success criteria appear to be standard and are considered acceptable; however the CHMP asked the Applicant to clarify the failed demonstration of bioequivalence regarding the parameter Cmax in the study report.
Maltese: Il-parametri, metodi użati għall-analiżi, u l-kriterji ta' suċċess stabbiliti jidhru li huma standard u huma meqjusin aċċettabbli; madankollu, is-CHMP talab lill-Applikant sabiex jiċċara n-nuqqas ta' turija ta' bijoekwivalenza fir-rigward tal-parametru Cmax fir-rapport tal-istudju.
English: The Applicant presented the results of two bioequivalence studies at a single oral dose of 40 mg, in healthy volunteers: PAN-2006/007 (fast study), PAN-2006/006 (fed study).
Maltese: PAN-2006/007 (studju f'sawm), PAN-2006/006 (studju wara ikla).
English: It was demonstrated that the effect of such delays on the absorption of pantoprazole in terms of the drug efficacy, in individual patients is relevant for AUC, but not for the Cmax as AUC correlates with the degree of acid suppression [Hatlebakk, 1996; Thompson, 1997].
Maltese: Intwera li l-effett ta' dewmien bħal dan fuq l-assorbiment ta' pantoprazole f'termini tal-effikaċja tal-mediċina, f'pazjenti individwali huwa relevanti għall-AUC, iżda mhux għas-Cmax minħabba li l-AUC jikkorrelata malammont ta' soppressjoni tal-aċidu [Hatlebakk, 1996;
English: The Applicant provided the evaluation of lag-times and % extrapolated AUC.
Maltese: L-Applikant ipprovda l-evalwazzjoni tal-ħinijiet ta' lag u l-% tal-AUC estrapolat.
English: In its first part the expert report displays the basic facts on pantoprazole PK and PD: the previously known properties of pantoprazole of a 77% bioavailability, an only modest delay of absorption, increased variability, but unaltered rate and extent of absorption when given with food.
Maltese: Flewwel parti tiegħu, ir-rapport tal-esperti juri l-fatti bażiċi dwar pantoprazole PK u PD: il-karatteristiċi magħrufin preċedentament ta' pantoprazole ta' bijodisponibbiltà ta' 77%, dewmien modest biss ta' assorbiment, varjabbiltà miżjuda, iżda rati u firxiet mhux mibdulin ta' assorbiment meta mogħti mal-ikel.
English: Initial Bioequivalence Studies
Maltese: Inizjali tal-Bijoekwivalenza
English: The CHMP noted that the expansion of the stated confidence interval for Cmax was not prospectively defined in the study protocol.
Maltese: Is-CHMP innota li l-espansjoni tal-intervall ta' fiduċja ddikjarat għal Cmax ma ġiex definit prospettivament filprotokoll tal-istudju.
English: Denmark Bluefish Pharmaceuticals AB Torsgatan 11
Maltese: Id-Danimarka Bluefish Pharmaceuticals AB Torsgatan 11
English: This, in general, is achieved if the AUC derived from measurements is at least 80 % of the AUC extrapolated to infinity.
Maltese: B'mod ġenerali, dan jintlaħaq jekk l-AUC miksub mill-kejl ikun għallinqas 80% tal-AUC estrapolat għallinfinità.
English: The Applicant submitted analytical reports for the studies.
Maltese: L-Applikant issottometta rapporti analitiċi għall-istudji.
English: According to this, pantoprazole is classified as a provisional BCS class III, i.e. a high solubility-low permeability drug.
Maltese: III provviżorja, jiġifieri mediċina ta' permeabilità għolja ta' solubilità baxxa.
English: LoOI-Q2: The Applicant was requested to state the batch size of the batch used for the new bioequivalence study for the test product.
Maltese: LoOI-Q2: L-Applikant intalab jiddikjara d-daqs tal-lott użat għall-istudju ta' bijoekwivalenza l-ġdid għallprodott tat-test.
English: Netherlands Bluefish Pharmaceuticals AB Torsgatan 11
Maltese: Il-Finlandja Bluefish Pharmaceuticals AB Torsgatan 11
English: The findings from the food interaction study together with the demonstration of bioequivalence in the fasting state (the recommended method of dosing), and with the extensive in vitro dissolution data (designed to mimic the gastric “milieu” after food) were considered to adequately exclude a formulation difference in terms of the integrity of the enteric coating and the risk of dose dumping.
Maltese: It-tisjib mill-istudji ta' interazzjoni tal-ikel flimkien mat-turija tal-bijoekwivalenza fl-istat ta' sawm (ilmetodu rrakkomandat tad-dożaġġ), u bid-dejta estensiva tad-dissoluzzjoni in vitro (imfassla sabiex timmimitizza l-“ambjent” gastriku wara l-ikel) tqiesu li jeskludu adegwatament differenza fil-formolazzjoni f'termini talintegrità tal-kisja enterika u r-riskju ta' dumping tad-doża.
English: It was anticipated that outliers would occur with both study groups (test and originator groups) in the fed study.
Maltese: Ġie antiċipat li dawk li ma jikkonformawx iseħħu biż-żewġ gruppi ta' studju (grupp tat-test u l-grupp oriġinatur) fl-istudju wara l-ikel.
English: ANNEX IV
Maltese: IV.
English: In addition, data on the PK parameters from study 2009-2106 were provided.
Maltese: Barra minn hekk, ġiet ipprovduta d-dejta fuq il-parametri tal-PK mill-istudju 2009-2016.
English: Bluefish Pharmaceuticals AB Torsgatan 11
Maltese: Il-Ġermanja Bluefish Pharmaceuticals AB Torsgatan 11
English: Hungary
Maltese: L-Olanda
English: The following Potential Serious Risk to Public Health (PSRPH) concern was therefore referred to the CHMP: the Study PAN 2006/006 (fed bioequivalence) did not adequately evaluate the properties of the test formulation in relation to the intake of a meal and the possibility of a formulation difference between the test and the reference product has therefore not been sufficiently excluded.
Maltese: It-tħassib għar-Riskju Serju Potenzjali għas-Saħħa Pubblika (PSRPH) li ġej ġie għaldaqstant riferut lis-CHMP: l-Istudju PAN 2006/06 (bijoekwivalenza wara ikla) ma evalwax il-karatteristiċi tal-formolazzjoni tat-test adegwatament fir-rigward tat-teħid ta' ikla u għaldaqstant, il-possibbiltà ta' differenza fil-formolazzjoni bejn il-prodott tat-test u l-prodott ta' referenza ma ġietx eskluża b'mod suffiċjenti.
English: The Applicant showed that the number of patients with an increased % of extrapolated AUC was very low and the variability in both parameters of interest was very high.
Maltese: L-Applikant wera li n-numru ta' pazjenti b'% miżjud ta' AUC estrapolat kien wieħed baxx ħafna u l-varjabbiltà fiż-żewġ parametri ta' interess kienet għolja ħafna.
English: ANNEX I
Maltese: L-Isvezja
English: The CHMP considered this issue resolved.
Maltese: Is-CHMP qies li din il-kwistjoni ġiet solvuta.
English: Based on a terminal elimination half-life of approximately 1 hour, three times the half-life was considered sufficient to cover the elimination of 83 % of the drug, and five times the half-life was considered to allow for almost complete elimination.
Maltese: Fuq il-bażi ta' half-life ta' eliminazzjoni terminali ta' madwar siegħa, tliet darbiet il-half-life ġie kkunsidrat biżżejjed biex ikopri leliminazzjoni ta' 83% tal-mediċina, u ħames darbiet il-half-life tqies li jippermetti eliminazzjoni kważi kompleta.
English: 150 mg Powder for concentrate for solution for infusion
Maltese: 150 mg Trab għal konċentrat għal soluzzjoni għallinfużjoni
English: 600 mg Solution for injection
Maltese: 600 mg Soluzzjoni għallinjezzjoni
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Maltese: Numru tal-MA (EU)
English: Subcutaneous use Vial (glass)
Maltese: Użu għal taħt ilġilda kunjett (ħġieġ) 5 ml
English: Pliva Ljubljana d.o.o.
Maltese: Pliva Hrvatska d.o.o.
English: OPA/Alu/PVC - Aluminium blisters.
Maltese: Folji OPA/Alu/PVC - Aluminju.
English: Leflunomide Teva contains lactose.
Maltese: Leflunomide Teva fih lactose.
English: hepatitis, jaundice/cholestasis
Maltese: epatite, suffejra/kolestasi
English: tenosynovitis
Maltese: tenosinovite
English: leucopenia (leucocytes > 2 G/l)
Maltese: lewkopenija (lewkoċiti > 2 G/l)
English: Teva Pharmaceutical Works Private Limited Company
Maltese: TEVA Pharmaceutical Works Private Limited Company Pallagi út 13
English: Classification of expected frequencies:
Maltese: bilirubin)) Klassifika tal-frekwenzi mistennija:
English: • Tablet core: lactose monohydrate, povidone, crospovidone type A, pregelatinized starch
Maltese: • Il-qalba tal-pillola: lactose monohydrate, povidone, crospovidone tip A, pregelatinized starch
English: • Tablet coating: titanium dioxide, hypromellose, macrogol 400, iron oxide yellow, polysorbate, quinoline yellow aluminium lake and indigo carmine aluminium Lake.
Maltese: • Il-kisi tal-pillola: titanium dioxide, hypromellose, macrogol 400, iron oxide yellow, polysorbate, quinoline yellow aluminium lake u indigo carmine aluminium Lake.
English: Immune system disorders Common:
Maltese: Disturbi tas-sistema immuni Komuni:
English: (maize), talc, anhydrous colloidal silica, lactose anhydrous and magnesium stearate.
Maltese: (qamħirrun), talc, anhydrous colloidal silica, lactose anidru u magnesium stearate.
English: • Tablet coating: titanium dioxide, polydextrose, hypromellose, triethyl citrate and macrogol
Maltese: • Il-kisi tal-pillola: titanium dioxide, polydextrose, hypromellose, triethyl citrate u macrogol
English: No difference was observed between leflunomide and sulphasalazine (study MN301).
Maltese: Ma dehret ebda differenza bejn leflunomide u sulphasalazine (studju MN301).
English: Teva UK Limited
Maltese: TEVA UK Ltd
English: Suomi/Finland ratiopharm Oy
Maltese: Suomi/Finland ratiopharm Oy Puh/Tel:
English: Each tablet contains 97.25 mg of lactose monohydrate and 3.125 mg anhydrous lactose.
Maltese: Kull pillola fiha 97.25 mg ta' lactose monohydrate u 3.125 mg lactose anidru.
English: In vitro studies indicate that A771726 inhibits cytochrome P4502C9 (CYP2C9) activity.
Maltese: Studji in vitro indikaw li l-A771726 jinibixxi l-attività taċ-ċitokromju P4502C9 (CYP2C9).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 March 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 10 ta' Marzu 2011
English: After stopping treatment with leflunomide:
Maltese: Wara li jitwaqqaf it-trattament ta' leflunomide:
English: - An increase of lactate dehydrogenase (a blood enzyme).
Maltese: - Żieda f'lactate dehydrogenase (enzima tad-demm).
English: This metabolite is responsible for essentially all the in vivo activity of leflunomide.
Maltese: Dan il-metabolit huwa essenzjalment responsabbli għall-attività kollha in vivo ta' leflunomide.
English: The risk of tuberculosis should be considered.
Maltese: Ir-riskju ta' tuberkolosi għandu jiġi meqjus.
English: - Dizziness.
Maltese: - Ekżema.
English: Each tablet contains 194.5 mg of lactose monohydrate and 6.25 mg anhydrous lactose.
Maltese: Kull pillola fiha 194.5 mg ta' lactose monohydrate u 6.25 mg lactose anidru.
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Uncommon:
Maltese: Komuni:
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day vs. placebo were 54.6 % vs. 28.6 % (study MN301), and 49.4 % vs. 26.3 % (study US301).After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3 % (studies MN301/303), 50.5 % (study MN302) and 49.4 % (study US301), compared to 53.8 % (studies MN301/303) in sulphasalazine patients, 64.8 % (study MN302), and 43.9 % (study US301) in methotrexate patients.
Maltese: Wara 12-il xahar ta' kura attiva, ir-rati ta' rispons ta' ACR fil-pazjenti fuq leflunomide kienu 52.3 % (studji MN301/303), 50.5 % (studju MN302) u 49.4 % (studju US301), meta mqabbla ma' 53.8 % (studji MN301/303) f'pazjenti fuq sulphasalazine, 64.8 % (studju MN302), u 43.9 % (studju US301) f'pazjenti fuq methotrexate.
English: Colestyramine 8 g is administered 3 times daily.
Maltese: Għandu jingħata 8 g ta' colestyramine 3 darbiet kuljum.
English: The ACR (American College of Rheumatology) response rates in study YU203 were 27.7 % for placebo, 31.9 % for 5 mg, 50.5 % for 10 mg and
Maltese: Ir-rati ta' rispons tal-ACR (American College of Rheumatology) fl-istudju YU203 kienu 27.7 % għal plaċebo, 31.9 % għal 5 mg, 50.5 % għal 10 mg u 54.5 % għal 25 mg/jum.