FrancophonIA/ELRC3.0 huggingface dataset:
English: Sometimes a single dose of adrenaline may not be sufficient to completely reverse the effects of a serious allergic reaction.
Maltese: Xi kultant doża waħda ta' adrenalina tista' ma tkunx biżżejjed biex tirriversja b'mod sħiħ l-effetti ta' reazzjoni allerġika serja.
English: It is recommended that your family members, carers or teachers are also instructed in the correct use of [Invented name].
Maltese: Huwa rakkomandat li l-membri tal-familja tiegħek, dawk li jipprovdu kura jew għalliema jingħataw istruzzjonijiet fl-użu korrett ta' [Isem ivvintat].
English: Section 4.4 - Special warnings and precautions for use [The section should be amended to reflect the following wording]
Maltese: Taqsima 4.4 - Twissijiet speċjali u prekawzjonijiet għall-użu [Din it-taqsima għandha tiġi emendata biex tirrifletti l-kliem li ġej]
English: If your symptoms have not improved or have deteriorated within 5-15 minutes after the first injection, either you or the person with you should give a second injection.
Maltese: Jekk is-sintomi tiegħek ma jkunux tjiebu jew ikunu marru għall-agħar fi żmien 5 minuti - 15-il minuta mill-ewwel injezzjoni, jew int jew il-persuna li qiegħed miegħek ikollu jagħtik ittieni injezzjoni.
English: The recommended dose for adults is 50 to 100 mg per m2 of body surface area for 5 days in a row or 100 to 120 mg/m2 on days 1, 3 and 5.
Maltese: Id-doża rrakkomandata għall-adulti hija ta' 50 sa 100 mg għal kull m2 tal-erja tas-superfiċje tal-ġisem għal 5 ijiem konsekuttivi jew ta' 100 sa 120 mg/m2 fil-jiem 1, 3 u 5.
English: EMA/251789/2017 Rev. 1 EMEA/H/A-30/1417
Maltese: 1 EMEA/H/A-30/1417
English: What is Etopophos?
Maltese: X'inhu Etopophos?
English: • acute myeloid leukaemia;
Maltese: • lewkimja majelojde akuta;
English: On 21 April 2017, the European Medicines Agency completed a review of Etopophos.
Maltese: Fil-21 ta' April 2017, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Etopophos.
English: • Hodgkin's and non-Hodgkin's lymphoma;
Maltese: • Limfoma ta' Hodgkin u mhux ta' Hodgkin;
English: The course of treatment may be repeated but not sooner than 21 days after the start of the first course.
Maltese: Il-kors tal-kura jista' jiġi ripetut iżda mhux qabel 21 jum wara li jkun inbeda lewwel kors.
English: Etopophos is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer, gestational trophoblastic neoplasia (a rare tumour of the womb that occurs during pregnancy) and cancers of the blood (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia).
Maltese: Etopophos huwa mediċina tal-kanċer li tintuża għall-kura ta': kanċer testikolari, kanċer tal-pulmun, kanċer tal-ovarji, neoplażija trofoblastika ġestazzjonali (tumur rari tal-ġuf li jseħħ waqt it-tqala) u kanċer tad-demm (linfoma ta' Hodgkin u mhux ta' Hodgkin u lewkimja majelojde akuta).
English: The company that markets these medicines is Bristol-Myers Squibb.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija Bristol-Myers Squibb.
English: The European Commission issued a decision on this opinion on 26/6/17.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fi 26/6/17.
English: • non-epithelial ovarian cancer.
Maltese: • kanċer epiteljali tal-ovarji.
English: Etopophos is authorised in the EU via national procedures.
Maltese: Etopophos huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: Etopophos contains the active substance etoposide (as etoposide phosphate) and is available as a powder to be made into a solution for infusion into a vein.
Maltese: Etopophos fih is-sustanza attiva etoposide (bħala fosfat tal-etoposide) u huwa disponibbli bħala trab li jitħallat biex issir soluzzjoni għal infużjoni ġo vina.
English: On 14 October 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Etopophos in the EU.
Maltese: Fl-14 ta' Ottubru 2015, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Etopophos fl-UE.
English: For blood cancers (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia), Etopophos is recommended for both adults and children, while its other uses are for adults only.
Maltese: Għal kanċers tad-demm (linfoma ta' Hodgkin u mhux ta' Hodgkin u lewkimja majelojde akuta), Etopophos huwa rakkomandat kemm għall-adulti kif ukoll għat-tfal, filwaqt li l-użi l-oħra tiegħu huma għall-adulti biss.
English: Why was Etopophos reviewed?
Maltese: Għaliex ġie rieżaminat Etopophos?
English: Etopophos is marketed in the following EU member States: France, Germany, Sweden and the United Kingdom.
Maltese: Etopophos jitqiegħed fis-suq fl-Istati Membri tal-UE li ġejjin: Franza, il-Ġermanja, l-Iżvezja u r-Renju Unit.
English: Etopophos was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Etopophos ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Etopophos and associated names in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni tal-preskrizzjoni għal Etopophos u ismijiet assoċjati fl-Unjoni Ewropea (UE).
English: • high-risk gestational trophoblastic neoplasia as first- and second-line treatments;
Maltese: • neoplażija trofoblastika ġestazzjonali bħala kura tal-ewwel u tat-tieni linja;
English: The CHMP recommended that Etopophos should be used in combination with other cancer treatments to treat the following cancers:
Maltese: Is-CHMP irrakkomanda li Etopophos għandu jintuża f'kombinazzjoni ma' kuri oħra kontra l-kanċer għall-kura tal-kanċers li ġejjin:
English: Etopophos should not be administered during vaccination with yellow fever or other live vaccines in patients with weakened immune systems and should not be given to breast-feeding women.
Maltese: Etopophos ma għandux jingħata waqt tilqim bid-deni isfar jew b'vaċċini ħajjin oħra f'pazjenti b'sistemi immuni dgħajfa u ma għandux jingħata lil nisa li qegħdin ireddgħu.
English: In addition, the CHMP recommended Etopophos for treating epithelial ovarian cancer that is resistant to treatments with platinum-containing medicines, with no specification that it should be used in combination with other medicines.
Maltese: Barra minn hekk, is-CHMP irrakkomanda Etopophos għall-kura ta' kanċer epiteljali tal-ovarji li huwa reżistenti għal kuri b'mediċini li fihom il-platinu, bl-ebda speċifikazzjoni li għandu jintuża f'kombinazzjoni ma' mediċini oħra.
English: It is also available in the EU under the trade name Etopofos.
Maltese: Huwa disponibbli wkoll fl-UE bl-isem kummerċjali Etopofos.
English: Denmark Teva Denmark A/S, Parallelvej 10,
Maltese: Id-Danimarka Teva Denmark A/S, Parallelvej 10,
English: BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda.
Maltese: Il-Portugall BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda.
English: Netherlands Bayer BV Energieweg 1
Maltese: Bayer BV Energieweg 1
English: 4745-457 S. Mamede do Coronado Portugal
Maltese: 4745-457 S. Mamede do Coronado Il-Portugall
English: 2794-003 Carnaxide Portugal
Maltese: 2794-003 Carnaxide
English: 3641 RT Mijdrecht Nederland
Maltese: 3641 RT Mijdrecht L-Olanda
English: BN22 9AG East Sussex United Kingdom
Maltese: BN22 9AG East Sussex
English: Denmark Teva UK Limited Brampton Road
Maltese: Id-Danimarka Teva UK Limited Brampton Road
English: BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX France
Maltese: BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX Franza
English: Hungary Bayer Hungária Kft Alkotás ut.50
Maltese: L-Ungerija Bayer Hungária Kft Alkotás ut.50
English: RECORDATI ESPAÑA, SL Carretera De Zeneta, 149 30588 Beniel (Murcia) Spain
Maltese: ESPAÑA, SL Carretera De Zeneta, 149 30588 Beniel (Murcia) Spanja
English: Berkshire RG14 1JA United Kingdom
Maltese: Berkshire RG14 1JA
English: 15125 Maroussi - Athens Greece
Maltese: 15125 Maroussi - Athens
English: 151 25 Marousi - Athens Greece
Maltese: 151 25 Marousi - Athens
English: Viale Certosa, 130 20156 Milano Italy
Maltese: Viale Certosa, 130 20156 Milano I-Italja
English: Luxembourg Therabel Pharma 110 Rue Egide Van Ochem 1180 Bruxelles
Maltese: Il-Lussemburgu Therabel Pharma 110 Rue Egide Van Ochem 1180 Bruxelles
English: Luxembourg Bayer s.a.-n.v. Avenue Louise 143 Louizalaan 1050 Bruxelles
Maltese: Il-Lussemburgu Bayer s.a.-n.v. Avenue Louise 143 Louizalaan 1050 Bruxelles
English: Via M. Civitali, 1 20148 Milano Italy
Maltese: Civitali, 1 20148 Milano I-Italja
English: Belgium Therabel Pharma S.A. Rue Egide Van Ophem 108 1180 Bruxelles
Maltese: Il-Belġju Therabel Pharma S.A. Rue Egide Van Ophem 108 1180 Bruxelles
English: 2800 Kongens Lyngby Denmark
Maltese: Kongens Lyngby Id-Danimarka
English: À Av. da Siderurgia Nacional P.O.
Maltese: Il-Portugall Bialfar - Produtos À Av. da Siderurgia Nacional P.O. Box 56
English: Bravničarjeva 13 1000 Ljubljana Slovenia
Maltese: 1000 Ljubljana
English: Ireland
Maltese: I-Irlanda
English: Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria
Maltese: L-Awstrija Bayer Austria GmbH Herbststraße 6-10
English: Iceland
Maltese: I-Islanda
English: QUÍMICA FARMACEUTICA BAYER, S. A. Av. Baix Llobregat, 3 y 5
Maltese: Baix Llobregat, 3 y 5
English: Belgium Bayer s.a.-n.v. Avenue Louise 143 Louizalaan B-1050 Bruxelles Belgium
Maltese: Il-Belġju Bayer s.a.-n.v. Avenue Louise 143 Louizalaan
English: Bayer Vital GmbH 51368 Leverkusen Germany
Maltese: Bayer Vital GmbH 51368 Leverkusen
English: Italy
Maltese: I-Italja
English: Bayer AG 51368 Leverkusen Germany
Maltese: Bayer AG 51368 Leverkusen
English: Bayer Health Care AG 51368 Leverkusen Germany
Maltese: Bayer Health Care AG 51368 Leverkusen
English: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Maltese: Sigma-Tau Industrie Farmaceutiche Riunite Moxifloxacin Actira
English: Box 56
Maltese: QUÍMICA FARMACEUTICA
English: Avalox 400 mg Filmtabletten 400 mg Film-coated tablet
Maltese: Avalox 400 mg Filmtabletten 400 mg Pillola miksija b'rita
English: Actira 400 mg film coated tablets400 mg Film-coated tablet
Maltese: Actira 400 mg film coated tablets400 mg Pillola miksija b'rita
English: Actira 400 mg - Filmtabletten 400 mg Film-coated tablet
Maltese: Actira 400 mg - Filmtabletten 400 mg Pillola miksija b'rita
English: Actimax 400 mg Filmtabletten 400 mg Film-coated tablet
Maltese: Actimax 400 mg Filmtabletten 400 mg Pillola miksija b'rita
English: Hungary
Maltese: Franza
English: Avelox 400 mg - Filmtabletten 400 mg Film-coated tablet
Maltese: Avelox 400 mg - Filmtabletten 400 mg Pillola miksija b'rita
English: Octegra 400 mg - Filmtabletten 400 mg Film-coated tablet
Maltese: Octegra 400 mg - Filmtabletten 400 mg Pillola miksija b'rita
English: Belgium Bayer AG 51368 Leverkusen Germany
Maltese: Il-Bulgarija Bayer AG 51368 Leverkusen
English: Netherlands Bayer HealthCare AG 51368 Leverkusen
Maltese: Il-Finlandja Bayer HealthCare AG 51368 Leverkusen
English: Luxembourg Bayer Healthcare AG 51368 Leverkusen
Maltese: Il-Lussemburgu Bayer Healthcare AG 51368 Leverkusen
English: Octegra 400 mg Filmtabletten 400 mg Film-coated tablet
Maltese: Octegra 400 mg Filmtabletten 400 mg Pillola miksija b'rita
English: Denmark Bayer HealthCare AG 51368 Leverkusen
Maltese: Id-Danimarka Bayer HealthCare AG 51368 Leverkusen
English: Actira 400 mg Filmtabletten 400 mg Film-coated tablet
Maltese: Actira 400 mg Filmtabletten 400 mg Pillola miksija b'rita
English: Sweden
Maltese: Wien
English: Member State EU/EEA
Maltese: Stat Membru UE/EEA
English: Absence of a Formulation Difference
Maltese: Nuqqas ta' Differenza bejn il-Formulazzjonijiet
English: Secondary Analysis
Maltese: Analiżi Sekondarja
English: According with Coupe A.J.
Maltese: Skont Coupe A.J. et al.
English: Safety results
Maltese: Riżultati tas-sigurtà
English: Confirmatory Pharmacokinetic Study (study code: 2009-2106)
Maltese: Studju Farmakokinetiku Konfermatorju (kodiċi ta' studju: 2009-2106)
English: 20 mg and 40 mg
Maltese: 20 mg 40 mg
English: The wash-out phase was 7 days.
Maltese: Il-fażi ta' wash-out kienet ta' 7 ijiem.
English: The mean ratio “test over reference” was calculated as 85.6 with 90 % confidence intervals of 77.6-95.6 %.
Maltese: Il-proporzjon medju “test fuq referenza” ġie kkalkolat bħala 85.6 b'90% intervalli ta' fiduċja ta' 77.6-95.6 %.
English: The Applicant showed that the ‘predefinition' of outliers was consistent with the current guidance on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 and in EMEA/CHMP/EWP/40326/2006).
Maltese: L-Applikant wera li l-‘predefinizzjoni' ta' dawk li ma jikkonformawx kienet konsistenti mal-gwida attwali dwar l-investigazzjoni ta' bijoekwivalenza (CPMP/EWP/QWP/1401/98 u f'EMEA/CHMP/EWP/40326/2006).
English: The originator medicinal product used in the bioequivalence studies was Pantecta 40 mg developed by Altana Pharma AG, Spain.
Maltese: Il-prodott mediċinali oriġinatur użat fl-istudji ta' bijoekwivalenza kien Pantecta 40 mg żviluppat minn Altana Pharma AG, Spanja.
English: The primary analysis was conducted on AUClast and Cmax, using the log-transformed ratios and 90 % Confidence Intervals (CIs).
Maltese: L-analiżi primarja twettqet fuq AUClast u Cmax, bl-użu ta' proporzjonijiet log-trasformati u 90% Intervalli ta' Fiduċja (Confidence Intervals - CIs).
English: Confirmatory Food Interaction Study -2009-2106
Maltese: Studju Konfermatorju dwar l-Interazzjoni mal-Ikel -2009-2106
English: Population studied
Maltese: Popolazzjoni studjata
English: The manufacturer was Altana for studies Pan 2006/006 and Pan 2006/007, and Nycomed for study 2009-2106.
Maltese: Il-manifattur għall-istudji Pan 2006/006 u Pan 2006/007 kien Altana, u għall-istudju 2009
English: Pantoprazole is a proton pump inhibitor (PPI), indicated for the treatment of gastrointestinal diseases associated with acid hypersecretion as gastric and duodenal ulcer, reflux oesophagitis (treatment and prevention of relapse) treatment of non-erosive gastroesophageal reflux disease (GERD), prevention non steroid anti-inflammatory drugs (NSAIDs) related ulcers, Zollinger-Ellison-Syndrome and eradication of H. pylori.
Maltese: Pantoprazole huwa inibitur ta' pompa tal-proton (PPI), indikat għall-kura ta' mard gastrointestinali assoċjat ma' ipersekrezzjoni ta' aċidi bħala kura għal ulċeri gastriċi u duodenali, esofaġite ta' rifluss (kura u prevenzjoni ta' rikaduta) ta' mard ta' rifluss gastroesofogeali (GERD), mediċini anti-infjammatorji mhux sterojdi ta' prevenzjoni (NSAIDs) relatati ma' ulċeri, is-Sindromu Zollinger-Ellison, il-Qerda ta' H. pylori.
English: Furthermore, an increase in T-max from 1-4 hours under fasting conditions to between 5 and 12 hours (attributed to delayed absorption with food) was published by the FDA in their Summary of Approval of the originator, Protonix 20 mg and Protonix 40 mg. [US FDA Summary of Approval Protonix 20 mg and Protonix 40 mg].
Maltese: Barra minn hekk, żieda fit-T-max minn 1-4 sigħat taħt kundizzjonijiet ta' sawm għal bejn 5 u 12-il siegħa (attribwita għal assorbiment imdewwem mal-ikel) ġiet ippubblikata mill-FDA fis-Sommarju ta' Approvazzjoni tal-oriġinatur tagħhom, Protonix 20 mg u Protonix 40 mg. [US FDA Sommarju ta' Approvazzjoni Protonix 20 mg u Protonix 40 mg].
English: GROUNDS FOR POSITIVE OPINION
Maltese: U RAĠUNIJIET GĦAL OPINJONI POŻITTIVA
English: Analytical Methods and Pharmacokinetic Variables
Maltese: Metodi Analitiċi u Varjabbli Farmakokinetiċi
English: For Cmax the confidence interval is 77.6-95.6% which is slightly below the acceptance interval (80-125) but the intraindividual variability (2 period 2 sequence design) is higher than 30% (36%), similar to the data reported in the literature for pantoprazole.
Maltese: Fil-każ tasCmax, l-intervall ta' fiduċja huwa ta' 77.6-95.6% li huwa xi ftit taħt l-intervall ta' aċċettazzjoni (80-125) iżda lvarjabbiltà individwali (disinn ta' 2 perijodi 2 sekwenzi) huwa ogħla minn 30% (36%), simili għad-dejta rrappurtata fil-letteratura għal pantoprazole.
English: The documentation of the analytical methods comprised an Analytical Report and a Re-validation report.
Maltese: Id-dokumentazzjoni tal-metodi analitiċi kienet tinkludi Rapport Analitiku u rapport ta' Validazzjoni mill-Ġdid.
English: The response to the third part (iii) has been provided separately.
Maltese: Ir-rispons għat-tielet parti (iii) ingħata separatament.
English: It included the requested data about long-term stability of human plasma samples along with long-term stability data of stock solutions (749 days at -25°C) and auto-sampler stability (122.5 hours at 5°C).
Maltese: Dan kien jinkludi d-dejta mitluba dwar l-istabbiltà fit-tul ta' kampjuni ta' plażma umana flimkien ma' dejta dwar l-istabbiltà fit-tul ta' soluzzjonijiet tal-istokk (749 jum f'temperatura ta' -25°C) u l-istabbiltà ta' auto-sampler (122.5 sigħat f'temperatura ta' 5°C).
English: Fleisher et al, 1996 and de Campos et al. 2007, described that BCS class III drugs present a highly variable pharmacokinetic disposition when taken with a meal due to a reduction of the absorption by simple physical barriers.
Maltese: Fleisher et al, 1996 u de Campos et al. 2007, iddeskrivew li mediċini ta' klassi
English: There were laboratory abnormalities in the post-study laboratory evaluations for altogether 11 subjects.
Maltese: Kien hemm anormalitajiet tal-laboratorju flevalwazzjonijiet tal-laboratorju ta' wara l-istudju għall-11-il suġġett kollha.
English: The samples were immediately stored at -25°C and transferred to the analytical facility.
Maltese: Il-kampjuni nħażnu minnufih f'-25°C u ġew trasferiti għall-faċilità analitika.
English: The Applicant submitted an additional validation study.
Maltese: L-Applikant issottometta studju addizzjonali ta' validazzjoni.
English: Introduction to the Study - PAN-2006-006, Food Interaction The Applicant presented the main analysis of the plasma samples excluding outliers in study PAN-2006/006 and also the analysis of the whole sample including all cases.
Maltese: Introduzzjoni għall-Istudju - PAN-2006-006, Interazzjoni mal-Ikel L-Applikant ippreżenta l-analiżi ewlenija tal-kampjuni tal-plażma minbarra dawk li ma jikkonformawx, flistudju PAN-2006/006 u wkoll l-analiżi tal-kampjun sħiħ inklużi l-każijiet kollha.
English: Bluefish Pharmaceuticals AB submitted two bioequivalence studies which compared the proposed 40 mg formulation to the reference product, Pantecta 40 mg gastro-resistant tablets; one study was conducted under fasting conditions [PAN-2006/007] and the other study under the fed condition [PAN-2006/006].
Maltese: Bluefish Pharmaceuticals AB ssottomettiet żewġ studji ta' bijoekwivalenza li qabblu l-formolazzjoni proposta ta' 40 mg mal-prodott ta' referenza, Pantecta 40 mg pilloli gastro-reżistenti; studju wieħed twettaq taħt kundizzjonijiet ta' sawm [PAN2006/007] u l-istudju l-ieħor twettaq taħt kundizzjoni wara ikla [PAN-2006/006].
English: The CHMP acknowledged that in and exclusion criteria, as well as subjects included, number and type of protocol deviations were considered acceptable.
Maltese: Is-CHMP għaraf li fi kriterji ta' approvazzjoni u esklużjoni, apparti s-suġġetti inklużi, numru u tipi ta' devjazzjonijiet għall-protokoll tqiesu aċċettabbli.
English: Pharmacokinetic Variables
Maltese: Varjabbli Farmakokinetiċi
English: The basis of Pantoprazole Bluefish application is the establishment of bioequivalence between the proposed generic formulation and the originator (Pantecta 40 mg by Altana Pharma AG, Spain).
Maltese: Il-bażi tal-applikazzjoni ta' Pantoprazole Bluefish hija l-istabbiliment ta' bijoekwivalenza bejn il-formolazzjoni ġenerika proposta u l-oriġinatur (Pantecta 40 mg minn Altana Pharma AG, Spanja).
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 0.80-1.25.
Maltese: Intużaw kriterji standard għall-bijoekwivalenza, jiġifieri 90% CI għallAUC u proporzjonijiet Cmax għandhom ikunu fi ħdan il-medda aċċettata ta' 0.80-1.25.
English: During the course of the study, 80 adverse events were reported.
Maltese: Matul il-kors tal-istudju, ġew irrapportati 80 episodju avvers.
English: The Applicant answered that a less strict requirement may apply for pantoprazole and submitted a report on the expected clinical relevance of the delayed absorption of pantoprazole observed in the study 2009-2106.
Maltese: L-Applikant wieġeb li jista' japplika rekwiżit inqas strett għal pantoprazole u ssottometta rapport dwar irrelevanza klinika mistennija tal-assorbiment imdewwem ta' pantoprazole osservat fl-istudju 2009-2106.
English: Given the main analysis results, the probability for bioinequivalency was evaluated by the Applicant and it resulted to be less than 1 % for Cmax and 0.02 % for AUClast.
Maltese: Mir-riżultati tal-analiżi prinċipali, il-probabbiltà għal bijoinekwivalenza ġiet evalwata mill-Applikant u rriżultat li kienet inqas minn 1% għal Cmax u 0.02 % għal AUClast.
English: For long-term stability a reduction was seen in pantoprazole content of between 6-8% of the nominal content, which was considered acceptable.
Maltese: Fil-każ tal-istabbiltà fit-tul deher tnaqqis fil-kontenut ta' pantoprazole ta' bejn is-6-8% tal-kontenut nominali, li kien meqjus aċċettabbli.
English: The Applicant justified the highly variable pharmacokinetics of pantoprazole, after food administration, referring to the biopharmaceutical classification system (BCS).
Maltese: L-Applikant iġġustifika l-farmakokinetiċi varjabbli ħafna ta' pantoprazole, wara l-amministrazzjoni tal-ikel, billi rrefera għas-sistema ta' klassifikazzjoni bijofarmaċewtika (biopharmaceutical classification system - BCS).
English: The Applicant presented the results of a further confirmatory fed study, with a final sampling point of 30 hours.
Maltese: L-Applikant ippreżenta r-riżultati ta' studju konfermatorju addizzjonali ta' tmigħ, b'punt finali ta' teħid ta' kampjuni ta' 30 siegħa.
English: Then the expert referred to two newer studies (De Campos DR et al: Drug Res 2007; Filipe A et al. Drug Res 2008; and Mendes Drug Res 2008) which revealed that administration of pantoprazole with food can provoke decreases in Cmax and AUC and markedly delay the absorption.
Maltese: Drug Res 2008; u Mendes Drug Res 2008) li kixfu li l-għoti ta' pantoprazole mal-ikel jista' jipprovoka tnaqqis fis-Cmax u fl-AUC u dewmien importanti fl-assorbiment.
English: In individual patients it was demonstrated that AUC, but not Cmax, correlates with the degree of acid suppression, which is known to correlate with the cure of acid-related diseases, and that there is no temporal association between the peak plasma concentration and the maximum acid suppression caused by the proton pump inhibitors [Hatlebakk, 1996].
Maltese: F'pazjenti individwali ntwera li AUC, iżda mhux Cmax, jikkorrelata mal-grad ta' soppressjoni tal-aċidi, li huwa magħruf li jikkorrelata mal-kura ta' mard relatat mal-aċidi, u li ma hemm ebda assoċjazzjoni temporanja bejn l-ogħla konċentrazzjoni tal-plasma u s-soppressjoni massima tal-aċidi kkawżata mill-inibituri tal-pompa tal-proton [Hatlebakk, 1996].
English: (iii) The results of additional dissolution testing, designed to mimic the gastric environment under fed conditions, and the further support provided by these data together with the discussion of the possible clinical relevance/applicability.
Maltese: (iii) Ir-riżultati ta' provi ta' dissoluzzjoni addizzjonali, imfasslin sabiex jimmimetizzaw l-ambjent gastriku taħt kundizzjonijiet ta' tmigħ, u l-appoġġ ulterjuri pprovdut minn din id-dejta flimkien mad-diskussjoni tar-relevanza klinika possibbli/applikabbiltà.