FrancophonIA/ELRC3.0 huggingface dataset:
English: Finally, the dosing regimen used1 was the previously approved posology for Levonelle, which was amended to a single 1500mcg dose following demonstration that the AUC0-∞ resulted in identical exposure and that there were no differences between the effectiveness or safety of LNG 2 x 750 mcg tablets (12 hour interval) and LNG 1500 mcg tablet administered as a single dose.
Maltese: Finalment, il-kors tad-dożaġġ użat1 kien il-pożoloġija approvata minn qabel għal Levonelle, li ġie emendat għal doża waħda ta' 1500 mcg wara li ntwera li l-AUC0-∞ irriżulta f'esponiment identiku u li ma kienx hemm differenzi bejn l-effettività jew is-sigurtà tal-pilloli LNG 2 x 750 mcg (intervall ta' 12il siegħa) u pillola LNG 1500 mcg mogħtija bħala doża waħda.
English: • The Committee considered the referral under Article 13(2) of Regulation No 1234/2008.
Maltese: • Il-Kumitat ikkunsidra r-referenza taħt l-Artikolu 13(2) tar-Regolament Nru 1234/2008.
English: Despite some variabilities overall, the data show consistent and marked reduction by about half of the plasma LNG levels during concomitant administration of efavirenz, with decreases in LNG AUC0-12 of >40% observed in 90% of the women.
Maltese: Minkejja xi varjabilitajiet b'mod ġenerali, id-data turi tnaqqis konsistenti u sostanzjali b'madwar nofs il-livelli tal-LNG fil-plażma waqt lgħoti konkomittanti ta' efavirenz, bi tnaqqis f'LNG AUC0-12 ta' >40 % osservat f'90 % tan-nisa.
English: Two parallel group studies examined contraceptive efficacy with lower doses of LNG: one study with 361 women observed similar crude pregnancy rates when LNG tablets were taken 8 hours after unprotected sexual intercourse (UPSI) using two formulations of 750mcg LNG tablets which were not bioequivalent.
Maltese: Żewġ gruppi ta' studju paralleli eżaminaw l-effikaċja tal-kontraċettivi b'dożi aktar baxxi ta' LNG: studju wieħed bi 361 mara osserva rati grossi ta' tqala simili meta l-pilloli tal-LNG ittieħdu 8 sigħat wara li kellhom x'jaqsmu sesswalment mingħajr protezzjoni (UPSI) bl-użu ta' żewġ formulazzjonijiet ta' pilloli tal-LNG ta' 750 mcg li ma kinux bijoekwivalenti.
English: The applied variation was to add efavirenz to the list of medicines interacting with levonorgestrel (LNG) to the summary of product characteristics (SmPC) and package leaflet (PL) for Levonelle 1500 microgram (mcg) tablets.
Maltese: Il-varjazzjoni applikata kienet sabiex iżżid efavirenz mal-lista ta' mediċini li jinteraġixxu ma' levonorgestrel (LNG) mas-sommarju tal-karatteristiċi tal-prodott (SmPC) u fuljett ta' tagħrif (PL) għallpilloli ta' Levonelle 1500 mikrogramma (mcg).
English: Cu-IUDs can be used up to 5 days following UPSI but this may not be an option for all women on medical grounds (e.g. following recent expulsion or perforation, recurrent vaginal infections, and increased risk of bleeding is undesirable for female HIV patients), due to access issues (lack of availability of appropriately skilled HCPs) or due to personal choice (e.g. for women not in long term relationships at the time of UPSI).
Maltese: UPSI imma dan mhux dejjem ikun possibbli għan-nisa kollha fuq bażi medika (eż. wara espulsjoni jew perforazzjoni riċenti, infezzjonijiet vaġinali rikorrenti, u żieda fir-riskju ta' fsada mhux mixtieqa għal pazjenti nisa bl-HIV), minħabba problemi ta' aċċess (nuqqas ta' disponibilità ta' HCPs bil-ħiliet xierqa) jew minħabba għażla personali (eż. għal nisa li mhumiex f'relazzjonijiet fit-tul fiż-żmien ta' UPSI).
English: The study of Carten et al. (2012)1, used a cross-over design, a clinically relevant dose of efavirenz and the size was reasonable for a drug-drug interaction (DDI) study.
Maltese: (2012)1, uża disinn komuni, doża ta' efavirenz klinikament rilevanti u d-daqs kien raġonevoli għal studju ta' interazzjoni bejn il-mediċini (DDI).
English: • The Committee reviewed all available data from clinical studies, published literature, postmarketing experience, including responses submitted by the marketing authorisation holder (MAH), in support of the efficacy and the safety of Levonelle 1500mcg and associated names in relation to the interaction with efavirenz.
Maltese: • Il-Kumitat irreveda d-data disponibbli kollha minn studji kliniċi, letteratura ppubblikata, esperjenza ta' wara t-tqegħid fis-suq, inkluż ir-risponsi ppreżentati mid-detentur talawtorizzazzjoni għat-tqegħid fis-suq (MAH), bħala appoġġ għall-effikaċja u s-sigurtà ta' Levonelle 1500 mcg u ismijiet assoċjati fir-rigward tal-interazzjoni ma' efavirenz.
English: Notably, there were 3 unintended pregnancies amongst efavirenz users in a 48 week study with LNG implants and the MAH has 6 post-marketing reports on their database of contraceptive failure with St John's wort, another enzyme inducer.
Maltese: B'mod partikolari, kien hemm 3 każijiet ta' tqala mhux intenzjonati fost l-utenti ta' efavirenz fi studju ta' 48 ġimgħa b'impjanti tal-LNG u l-MAH kellu 6 rapporti ta' wara t-tqegħid fissuq fil-bażi tad-data tiegħu ta' falliment tal-kontraċettiv b'St John's wort, induttur tal-enzima ieħor.
English: 3 Croxatto HB, Brache V, Pavez M, Cochon L, Forcelledo ML, Alvarez F, et al. (2004) Pituitary ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75-mg dose given on the days preceding ovulation.
Maltese: (2004) Pituitary ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75-mg dose given on the days preceding ovulation. Contraception 70(6):442-50
English: The type II variation started on 17 September 2014.
Maltese: Il-varjazzjoni tat-tip II bdiet fis-17 ta' Settembru 2014.
English: Furthermore the Committee discussed data regarding other hepatic enzyme inducers including barbiturates and other medicines to treat epilepsy, medicines used to treat tuberculosis like rifampicin and herbal medicines containing Saint John's wort.
Maltese: Barra minn hekk il-Kumitat iddiskuta data rigward indutturi tal-enzima tal-fwied oħrajn inkluż barbiturati u mediċini oħrajn għall-kura tal-epilessija, mediċini użati għall-kura tat-tuberkulożi bħal rifampicin u mediċini mill-ħxejjex li fihom Saint John's wort.
English: The recent study with LNG-containing emergency contraception1 showed that concomitant administration of efavirenz reduces plasma levels of LNG (AUC) by around 50%.
Maltese: L-istudju riċenti dwar kontraċezzjoni ta' emerġenza li fiha l-LNG1 wera li l-għoti konkomittanti ta' efavirenz inaqqas il-livelli tal-LNG fil-plażma (AUC) b'madwar 50 %.
English: Currently two other forms of emergency contraception are available, ulipristal acetate and Cu-IUDs.
Maltese: Bħalissa huma disponibbli żewġ forom oħra ta' kontraċezzjoni ta' emerġenza, ulipristal acetate u Cu-IUDs.
English: The CHMP agreed that plasma exposure levels of LNG vary between women, but data from studies with combined hormonal contraceptives have indicated that plasma LNG levels are consistently reduced by concomitant use of liver enzyme inducers, mainly inducers of CYP3A4 enzymes.
Maltese: Is-CHMP qabel li l-livelli tal-esponiment tal-LNG fil-plażma jvarjaw bejn in-nisa, imma d-data minn studji b'kontraċettivi ormonali kombinati indikaw li l-livelli tal-LNG fil-plażma jitnaqqsu b'mod konsistenti permezz tal-użu konkomittanti tal-indutturi tal-enzima tal-fwied, prinċipalment indutturi talenzimi CYP3A4.
English: Although there are few adverse drug reaction (ADR) reports of contraceptive failure during concomitant use of enzyme inducers with LNG EHC, and none with efavirenz specifically, this is likely linked to significant under-reporting for loss of efficacy in general when expected contraceptive failure rates and widespread use of LNG EHC are considered.
Maltese: Għalkemm kien hemm ftit rapporti ta' reazzjoni avversa tal-mediċina (ADR) waqt l-użu konkomittanti tal-indutturi tal-enzima b'LNG EHC, u l-ebda wieħed speċifikament b'efavirenz, dan x'aktarx huwa marbut ma' nuqqas ta' rappurtar sinifikanti għal telf tal-effikaċja b'mod ġenerali meta jiġu kkunsidrati rati ta' falliment tal-kontraċettivi mistennija u l-użu mifrux ta' LNG EHC.
English: The SmPCs for regular contraception products containing LNG advise using additional or alternative methods of contraception, depending on the duration of use of the enzyme inducer.
Maltese: L-SmPCs għal prodotti ta' kontraċezzjoni regolari li fihom l-LNG jagħtu l-parir biex jintużaw metodi ta' kontraċezzjoni addizzjonali jew alternattivi, skont it-tul ta' żmien tal-użu tal-induttur tal-enzima.
English: This is important as contraceptive efficacy of LNG EHC diminishes with time since UPSI: from 95% within 24 hours to 58% if started between 48 and 72 hours.
Maltese: Dan huwa importanti minħabba li l-effikaċja talkontraċettivi ta' LNG EHC tonqos maż-żmien minn UPSI: minn 95 % fi żmien 24 siegħa għal 58 % jekk jinbeda bejn 48 u 72 siegħa.
English: The CHMP was requested to give its opinion on whether a double dose of LNG 1500 mcg would be a suitable form of emergency contraception for patients taking concomitant hepatic enzyme inducers after unprotected intercourse or failure of a contraceptive method, in particular women who are unwilling or unable to use non-hormonal methods, such as a copper-based intra-uterine device (Cu IUD).
Maltese: Is-CHMP kien mitlub jagħti l-opinjoni tiegħu dwar jekk doża doppja ta' LNG 1500 mcg tkunx forma xierqa ta' kontraċezzjoni ta' emerġenza għal pazjenti li jieħdu indutturi tal-enzimi tal-fwied konkomittanti wara li jkollhom x'jaqsmu sesswalment mingħajr protezzjoni jew falliment ta' metodu kontraċettiv, b'mod partikolari nisa li mhumiex lesti jew ma jistgħux jużaw metodi mhux ormonali, bħall-apparat ta' ġewwa l-utru bbażat fuq ir-ram (Cu IUD).
English: Limited data with a 6mg dose of LNG shows higher Cmax than seen with 1.5mg, suggesting that saturation of LNG uptake does not occur at the standard EHC dose.
Maltese: Data limitata b'doża ta' 6 mg ta' LNG turi Cmax ogħla milli muri b'1.5 mg, u dan jissuġġerixxi li s-saturazzjoni tal-assorbiment ta' LNG ma jseħħx bid-doża standard ta' EHC.
English: Currently the SmPC and PL for Levonelle 1500mcg and associated names list a number of enzyme inducers which may affect contraceptive efficacy but do not provide any information on the magnitude of the effect or advice on appropriate management of the interaction, other than for the woman to tell her doctor.
Maltese: Bħalissa l-SmPC u l-PL ta' Levonelle 1500 mcg u ismijiet assoċjati jelenkaw numru ta' indutturi ta' enzimi li jistgħu jaffettwaw l-effikaċja tal-kontraċettivi imma ma jipprovdux informazzjoni dwar id-daqs tal-effett jew parir dwar l-immaniġġjar xieraq tal-interazzjoni, ħlief għall-mara li tgħid lit-tabib tagħha.
English: On 1 October 2015, the United Kingdom (UK) as RMS triggered a referral under Article 13(2) of the Commission Regulation (EC) No 1234/2008.
Maltese: Fl-1 ta' Ottubru 2015, ir-Renju Unit (UK) bħala RMS ta bidu għal riferiment skont l-Artikolu 13(2) tarRegolament tal-Kummissjoni (KE) Nru 1234/2008.
English: Therefore the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - human (CMDh), under Article 13(1), paragraph 1 of Regulation EC No 1234/2008 by UK on 17 June 2015.
Maltese: Għaldaqstant il-proċedura kienet riferuta lill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh), skont l-Artikolu 13(1), paragrafu 1 tar-Regolament KE Nru 1234/2008 mir-Renju Unit fis17 ta' Ġunju 2015.
English: This is recognised in clinical guidance and in the product information of hormonal contraceptives which advise use of additional or alternative contraception.
Maltese: Dan huwa rikonoxxut fi gwida klinika u fl-informazzjoni tal-prodott ta' kontraċettivi ormonali li tagħti l-parir għall-użu ta' kontraċezzjoni addizzjonali jew alternattiva.
English: The product information for ulipristal acetate advises to avoid use with concurrent enzyme inducers due to enhanced metabolism.
Maltese: L-informazzjoni tal-prodott għal ulipristal acetate tagħti lparir sabiex jiġi evitat użu ma' indutturi tal-enzima konkomittanti minħabba l-metaboliżmu msaħħaħ.
English: Currently the minimally effective dose for LNG EHC is not known.
Maltese: Bħalissa d-doża effettiva minima għal LNG EHC mhux magħrufa.
English: For non-emergency forms of LNG-containing contraception, the decreased efficacy resulting from reduced plasma levels are considered to lead to in an increased risk of pregnancy.
Maltese: Għal kontraċettivi li fihom forom mhux ta' emerġenza ta' LNG, in-nuqqas tal-effikaċja li jirriżulta minn tnaqqis fil-livelli tal-plażma hu kkunsidrat li jwassal għal żieda fir-riskju ta' tqala.
English: To the extent that other 750mcg and 1500mcg LNG-containing medicinal products indicated in emergency contraception not included in this assessment but are currently authorised in the EU, or are subject to future authorisation procedures by the Member States, the CHMP recommends that the concerned member states take due consideration of these scientific conclusions.
Maltese: F'każ li prodotti mediċinali oħrajn ta' 750 mcg u 1500 mcg li fihom l-LNG indikati fil-kontraċezzjoni ta' emerġenza mhux inklużi f'din il-valutazzjoni imma li bħalissa huma awtorizzati fl-UE, jew huma soġġetti għal proċeduri ta' awtorizzazzjoni fil-futur mill-Istati Membri, is-CHMP jirrakkomanda li l-Istati Membri kkonċernati jqisu dawn il-konklużjonijiet kif xieraq.
English: Part of this advice to women is for a dose adjustment to counteract reduced plasma LNG levels when EFV and the other enzyme inducing medicines are used.
Maltese: Parti minn dan il-parir għan-nisa huwa għal aġġustament fid-doża sabiex jikkontrobatti t-tnaqqis fillivelli tal-LNG fil-plażma meta jintużaw EFV u l-mediċini l-oħrajn li jinduċu l-enzima.
English: Non-clinical data, a prospective cohort study investigating human pregnancy outcomes after LNG EHC failure, and data from post-marketing reports of overdose all suggest that overdosing (on a one-off or occasional basis) does not cause severe adverse reactions and no new safety concerns were raised.
Maltese: Id-data mhux klinika, l-istudju tal-koorti prospettiv li jinvestiga r-riżultati ta' tqala tal-bniedem wara l-falliment ta' LNG EHC, u d-data minn rapporti ta' wara t-tqegħid fis-suq ta' doża eċċessiva kollha jissuġġerixxu li doża eċċessiva (fuq bażi ta' darba jew ta' kultant) ma tikkawżax reazzjonijiet avversi serji u ma tqajjimx tħassib ġdid dwar is-sigurtà.
English: • The CHMP concluded that in view of the available data for Levonelle 1500mcg and associated names, information should be available on the effect of efavirenz and other hepatic enzyme inducers when taken concomitantly, or for 4 weeks after cessation of treatment with all enzyme inducers.
Maltese: • Is-CHMP ikkonkluda li fid-dawl tad-data disponibbli għal Levonelle 1500 mcg u ismijiet assoċjati, għandha tkun disponibbli informazzjoni dwar l-effett ta' efavirenz u indutturi talenzima tal-fwied oħrajn meta jittieħdu b'mod konkomittanti, jew għal 4 ġimgħat wara t-twaqqif tal-kura bl-indutturi tal-enzima kollha.
English: The CHMP reviewed all data available from clinical studies, published literature, post-marketing experience, including responses submitted by the MAH in writing, as well as the results of a written consultation with patients and consumers, and healthcare professionals across the EU.
Maltese: Is-CHMP irreveda d-data disponibbli kollha minn studji kliniċi, letteratura ppubblikata, esperjenza wara t-tqegħid fis-suq, inkluż risponsi ppreżentati mill-MAH bil-miktub, kif ukoll riżultati ta' konsultazzjoni bil-miktub ma' pazjenti u konsumaturi, u professjonisti tal-kura tas-saħħa madwar l-UE.
English: A relevant summary of the conclusions is presented below.
Maltese: Sommarju rilevanti tal-konklużjonijiet huwa ppreżentat hawn taħt.
English: Conversely, a double dose may over compensate the effects of less strong enzyme inducers.
Maltese: Bil-kontra, doża doppja tista' tikkumpensa żżejjed l-effetti ta' indutturi tal-enzima anqas b'saħħithom.
English: (‘microheterogeneity').
Maltese: (“mikroeteroġenità”).
English: Insulin 5,808 daltons
Maltese: Insulina 5,808 daltons
English: European Commission: What I need to know about biosimilar medicines.
Maltese: What I need to know about biosimilar medicines.
English: Substitution
Maltese: Sostituzzjoni
English: European Medicines Agency: Immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use.
Maltese: Immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use.
English: European Medicines Agency: Guideline on good pharmacovigilance practices (GVP), Product- or Population-Specific Considerations II: Biological medicinal products.
Maltese: L-Aġenzija Ewropea tal-Mediċini: Guideline on good pharmacovigilance practices (GVP), Product- or Population-Specific Considerations II: Biological medicinal products.
English: Determining factor
Maltese: Fattur determinanti
English: Monoclonal antibody 150,000 daltons
Maltese: Antikorp monoklonali 150,000 daltons
English: Usually produced by chemical synthesis
Maltese: Normalment prodotta b'sinteżi kimika
English: European Medicines Agency: Immunogenicity assessment of biotechnology-derived therapeutic proteins.
Maltese: Immunogenicity assessment of biotechnologyderived therapeutic proteins.
English: Comparability
Maltese: Komparabbiltà
English: European Medicines Agency: ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products.
Maltese: L-Aġenzija Ewropea tal-Mediċini: ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products.
English: EMA/CHMP/BMWP/86289/2010.
Maltese: EMA/CHMP/BMWP/86289/2010. http://www.
English: Pharmacokinetic/pharmacodynamic Efficacy + safety + immunogenicity
Maltese: Studji kliniċi komparattivi Farmakokinetiċi/farmakodinamiċi Effikaċja + sikurezza + immunoġeniċità
English: Foreword by Prof. Guido Rasi EMA Executive Director
Maltese: Guido Rasi, Direttur Eżekuttiv tal-EMA
English: Biosimilar approved in the EU (as at October 2019)
Maltese: Bijosimili approvata l-UE (09/2019)
English: Insulin glargine Somatropin (growth hormone) Teriparatide
Maltese: Follitropin alfa Insulin glargine Somatropin (ormon tat-tkabbir) Teriparatide;
English: Definitions
Maltese: Definizzjonijiet
English: IMS Health, The impact of biosimilar competition, June 2016. http://ec.europa.eu/ growth/tools-databases/newsroom/cf/itemdetail.
Maltese: IMS Health, The impact of biosimilar competition, June 2016. http://ec.europa. eu/growth/tools-databases/newsroom/cf/ itemdetail.cfm?item_id=8854.
English: Growth hormone 22,000 daltons
Maltese: Ormon tat-tkabbir 22,000 daltons
English: Food and Drug Administration (the US medicines regulatory authority)
Maltese: Food and Drug Administration (l-awtorità regolatorja tal-Istati Uniti għall-mediċini)
English: Large molecular structure
Maltese: Struttura molekulari kbira
English: Accessed on 6 March 2017.
Maltese: Aċċessat fis-6 ta' Marzu 2017.
English: Contributors
Maltese: Kontributuri
English: European Medicines Agency: Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues.
Maltese: L-Aġenzija Ewropea tal-Mediċini: Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues.
English: Biomanufacturing strictly regulated
Maltese: Il-bijomanifattura regolata strettament
English: Comparative quality studies Analytical: physical + chemical properties Functional: biological/pharmacological activity
Maltese: Studji tal-kwalità komparattivi Analitiċi: proprjetajiet fiżiċi + kimiċi Funzjonali: attività bijoloġika/farmakoloġika
English: Glossary
Maltese: Glossarju
English: Weise M, Bielsky MC, De Smet K, et al. Biosimilars: what clinicians should know.
Maltese: Weise M, Bielsky MC, De Smet K, et al.
English: Accessed on 10 April 2017.
Maltese: Aċċessat fl-10 ta' April 2017.
English: http://www.ema.
Maltese: Rev. 1. http://www.
English: Similar biotherapeutic products (WHO term for biosimilars)
Maltese: Prodotti bijoterapewtiċi simili (terminu tad-WHO għall-bijosimili)
English: Kurki P, van Aerts L, Wolff-Holz E, et al. Interchangeability of biosimilars: a European perspective.
Maltese: Kurki P, van Aerts L, Wolff-Holz E, et al.
English: Comprehensive physicochemical and functional in vitro studies
Maltese: Studji fiżikokimiċi u funzjonali in vitro komprensivi
English: * The definitions included in this document and in the glossary are descriptions, not regulatory definitions.
Maltese: * Id-definizzjonijiet inklużi f'dan id-dokument u fil-glossarju huma deskrizzjonijiet, mhux definizzjonijiet regolatorji.
English: Step 1 Comparative quality studies
Maltese: Stadju 1 Studji komparattivi tal-kwalità
English: Biosimilar medicines: definition and features
Maltese: Mediċini bijosimili: definizzjoni u karatteristiċi
English: A robust regulatory framework to protect patients' safety
Maltese: Qafas regolatorju robust għall-protezzjoni tassikurezza tal-pazjenti
English: Over 50 biosimilars have been approved through EMA for use in the EU as at April 2017.
Maltese: Ġew approvati iktar minn 50 bijosimili permezz talEMA għall-użu fl-UE sa April 2017.
English: Weise M, Kurki P, Wolff-Holz E, et al. Biosimilars: the science of extrapolation.
Maltese: Weise M, Kurki P, Wolff-Holz E, et al.
English: Epoetin Filgrastim Pegfilgrastim
Maltese: Pegfilgrastim
English: Potential immunogenicity
Maltese: Immunoġeniċità potenzjali
English: Deoxyribonucleic acid
Maltese: Aċidu deossiribonuklejiku
English: Approval of medicines in the EU relies on a solid legal framework, which in 2004 introduced a dedicated route for the approval of biosimilars.
Maltese: L-approvazzjoni tal-mediċini fl-UE hi bbażata fuq qafas legali solidu, li fl-2004 introduċa rotta ddedikata għall-approvazzjoni tal-bijosimili.
English: Biotechnology
Maltese: Bijoteknoloġija
English: Post-translational change
Maltese: Tibdil posttraduzzjonali
English: PD endpoints are usually based on laboratory tests.
Maltese: Il-punti ta' tmiem PD normalment ikunu bbażati fuq testijiet tal-laboratorju.
English: Reference medicine Biosimilar medicine
Maltese: Mediċina ta' referenza Mediċina bijosimili
English: Additional monitoring and black triangle
Maltese: Monitoraġġ addizzjonali u triangolu iswed
English: Step 3 Comparative clinical studies
Maltese: Stadju 3 Studji kliniċi komparattivi
English: Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands
Maltese: 1083 HS Amsterdam
English: Summary
Maltese: Sommarju
English: “This medicinal product is subject to additional monitoring”
Maltese: “Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali”
English: Anti-drug antibody Antibodies produced by the body's immune system against an active substance (particularly a large molecule, such as a protein).
Maltese: Antikorpi prodotti mis-sistema immunitarja tal-ġisem kontra sustanza attiva (b'mod partikolari molekula kbira, bħal proteina).
English: Accessed on 14 March 2017.
Maltese: Aċċessat fl-14 ta' Marzu 2017.
English: European Medicines Agency: Similar biological medicinal products containing biotechnologyderived proteins as active substance: non-clinical and clinical issues.
Maltese: L-Aġenzija Ewropea tal-Mediċini: Similar biological medicinal products containing biotechnology- derived proteins as active substance: non-clinical and clinical issues. EMEA/ CHMP/BMWP/42832/2005
English: Examples of types of proteins in biological medicines approved in the EU
Maltese: Eżempji ta' tipi ta' proteini f'mediċini bijoloġiċi approvati fl-UE
English: Extrapolation across different clinical settings
Maltese: Estrapolazzjoni fost kuntesti kliniċi differenti
English: Comparative clinical studies Safety and efficacy PK/PD
Maltese: Studji kliniċi komparattivi Sikurezza u effikaċja PK/PD
English: Anti-drug antibody
Maltese: Antikorp kontra d-droga
English: Adverse reactions of an immune nature (e.g. infusion-related reactions or injection-site reactions) are normally not severe.
Maltese: Ir-reazzjonijiet avversi ta' natura immuni (eż. reazzjonijiet relatati mal-infużjoni jew reazzjonijiet fis-sit tal-injezzjoni) normalment ma jkunux severi.
English: Batch 2
Maltese: Lott 2