FrancophonIA/ELRC3.0 huggingface dataset:
English: Significant recommendations for approval in 2010 Public-health benefits of medicines for human use recommended for approval in 2010
Maltese: Rakkomandazzjonijiet sinifikanti għall-approvazzjoni fl-2010 Benefiċċji għas-saħħa pubblika ta' mediċini għall-użu mill-bniedem rakkomandati għall-approvazzjoni fl-2010
English: Veterinary medicines
Maltese: Mediċini għall-użu veterinarju
English: Initial applications (by medicinal product) Initial applications (by active substance)
Maltese: Applikazzjonijiet inizjali (skont il-prodott mediċinali) Applikazzjonijiet inizjali (skont is-sustanza attiva)
English: • EMA strengthens rules on conflicts of interests for its scientific experts.
Maltese: • EMA ssaħħaħ ir-regoli dwar kunflitti ta' interess għall-esperti xjentifiċi tagħha.
English: • EMA adopts first opinion on compassionate use, for oseltamivir, to treat patients with a life threatening condition due to pandemic or seasonal flu.
Maltese: • L-EMA tadotta l-ewwel opinjoni dwar l-użu b'kompassjoni, għal oseltamivir, sabiex jiġu kkurati pazjenti b'kundizzjoni ta' theddida għall-ħajja minħabba l-influwenza pandemika jew dik staġjonali.
English: • EMA and European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP)
Maltese: • L-EMA u n-Netwerk Ewropew ta' Ċentri għall-Farmakoepidemjoloġija u Farmakoviġilanza (ENCePP) iniedu 'l-istudji tal-ENCePP' - siġill għal studji avvanzati u trasparenti dwar is-sigurtà
English: Herbal monographs List entries
Maltese: Applikazzjonijiet ghal evalwazzjoni inizjali
English: Initial-evaluation applications received
Maltese: Applikazzjonijiet għal evalwazzjoni inizjali riċevuti
English: • Committee for Advanced Therapies gives first certification opinion for an advanced therapy medicinal product.
Maltese: • Il-Kumitat għal Terapiji Avvanzati jagħti l-ewwel opinjoni ta' ċertifikazzjoni għal prodott mediċinali ta' terapija avvanzata.
English: This includes the management of suspected ADRs in the pre- and post-authorisation phase, periodic safety-update reports (PSURs), risk-management plans (RMPs) and post-authorisation safety and efficacy/effectiveness studies.
Maltese: Dan jinkludi l-ġestjoni ta' ADRs suspetti fil-fażi ta' qabel u ta' wara l-awtorizzazzjoni, rappurtar ta' aġġornament perjodiku dwar is-sikurezza (PSURs), pjanijiet ta' ġestjoni tar-riskju (RMPs) u studji dwar is-sikurezza wara l-awtorizzazzjoni u l-effiċjenza/ effikaċja.
English: The Agency establishes maximum residue limits (MRLs) for pharmacologically active substances used to treat animals, to provide for the safe use of foodstuffs of animal origin, including meat, fish, milk, eggs and honey.
Maltese: L-Aġenzija tistabbilixxi limiti massimi ta' residwi (MRLs) għal sustanzi farmakoloġikament attivi użati fit-trattament tal-annimali, biex tipprovdi għall-użu sikur ta' ikel li joriġina mill-annimali, inkluż il-laħam, il-ħut, il-ħalib, il-bajd u l-għasel.
English: EEA and non-EEA adverse-drug-reaction reports received
Maltese: Punti ewlenin tar-rapport annwali
English: The total number of inspections was 20% above the forecast, mainly due to an unexpected increase in the number of good-clinical-practice (GCP) inspections requested.
Maltese: In-numru totali ta' spezzjonijiet kien ta' 20% iktar mill-previżjoni, l-aktar minħabba żieda mhux mistennija fl-għadd ta' spezzjonijiet għal prattika klinika tajba (GCP) mitluba.
English: Scientific Advice
Maltese: Parir xjentifiku
English: • EMA launches SME database to facilitate interaction between small and medium-sized enterprises.
Maltese: • L-EMA tniedi bażi ta' dejta għall-SMEs biex tiffaċilità l-interazzjoni bejn intrapriżi żgħar u medji.
English: • A medicinal product intended for the treatment of a musculoskeletal condition known as Dupuytren's contracture, presenting a non-surgical alternative.
Maltese: • Prodott mediċinali maħsub għall-kura ta' kundizzjoni muskuloskeletali magħrufa bħala lkontrazzjoni ta' Dupuytren, jippreżenta alternattiva mhux kirurġika.
English: CAP EEA ADRs CAP non-EEA ADRs Non-CAP EEA ADRs non-CAP non-EEA ADRs EEA = European Economic Area.
Maltese: • L-Aġenzija Ewropea għall-Mediċini (EMA) tniedi konsultazzjoni dwar il-'Pjan direzzjonali għall-2015' tagħha.
English: Number of inspections
Maltese: Numru ta' spezzjonijiet
English: Initial evaluation covers activities relating to the processing of marketing authorisation applications for medicines, from pre-submission discussion with future applicants, through evaluation by the CHMP, to the granting of a marketing authorisation by the European Commission.
Maltese: Evalwazzjoni inizjali tkopri attivitajiet relatati mal-ipproċessar tal-applikazzjonijiet tal-awtorizzazzjoni għat-tqegħid fis-suq għall-mediċini, minn diskussjoni ta' qabel is-sottomissjoni ma' applikanti futuri, permezz ta' evalwazzjoni min-naħa tas-CHMP, għall-għoti ta' awtorizzazzjoni għat-tqegħid fis-suq millKummissjoni Ewropea
English: International non-proprietary name (inn): doramectin
Maltese: Denominazzjoni internazzjonali komuni (inn): doramectin
English: The Committee appointed Mr G. J. Schefferlie as rapporteur and Dr B. Kolar as co-rapporteur.
Maltese: Il-Kumitat ħatar lis-Sur G. J. Schefferlie bħala rapporteur u lidDr B. Kolar bħala co-rapporteur.
English: The referral started on 12 April 2012.
Maltese: Ir-riferiment beda fit-12 ta' April 2012.
English: Opinion following an Article 350F referral for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species
Maltese: Opinjoni wara referenza skont l-Artikolu 3510F għall-mediċinali veterinarji injettabbli u għat-tferrigħ kollha li fihom doramectin u li huma maħsubin biex jintużaw fi speċi mammali li jipproduċu l-ikel
English: Written explanations were provided by the applicants and marketing authorisation holders on 17 September 2012, 3 January 2013 and 9 May 2013.
Maltese: Fis-17 ta' Settembru 2012, it-3 ta' Jannar 2013 u d-9 ta' Mejju 2013, ġew ipprovduti spjegazzjonijiet bil-miktub mill-applikanti u d-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: On 22 March 2012, the Netherlands presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species.
Maltese: Fit-22 ta' Marzu 2012, il-Pajjiżi l-Baxxi ppreżentaw lill-Aġenzija Ewropea għall-Mediċini notifika ta' riferiment skont l-Artikolu 35 tad-Direttiva 2001/82/KE għall-prodotti mediċinali veterinarji injettabbli u għat-tferrigħ kollha li fihom doramectin li huma maħsubin sabiex jintużaw fi speċi mammali li jipproduċu l-ikel.
English: The CVMP was requested to give its opinion regarding the adequacy and consumer safety of the withdrawal periods for all injectable and pour-on veterinary medicinal products containing doramectin and whether there is a risk to the environment and the need for risk mitigation measures following use of the products concerned.
Maltese: Is-CVMP intalab jagħti l-opinjoni tiegħu dwar l-adegwatezza u s-sigurtà talkonsumatur tal-perjodi ta' tiżmim għall-prodotti mediċinali veterinarji injettabbli u għat-tferrigħ kollha li fihom doramection u jekk hemmx riskju għall-ambjent u l-ħtieġa ta' miżuri ta' mitigazzjoni wara lużu tal-prodott ikkonċernat.
English: Therefore, the Committee adopted a positive opinion on 12 June 2013, recommending variations to the terms of the marketing authorisations for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species.
Maltese: Għalhekk, il-Kummissjoni adottat opinjoni pożittiva fit-12 ta' Ġunju 2013, li tirrakkomanda varjazzjonijiet fit-termini tal-awtorizzazzjonijiet għattqegħid fis-suq għall-prodotti mediċinali veterinarji injettabbli u għat-tferrigħ li fihom doramecton li huma maħsubin sabiex jintużaw fi speċi mammali li jipproduċu l-ikel.
English: 6 September 2013
Maltese: EMA/372468/2013
English: The final opinion was converted into a Decision by the European Commission on 6 September 2013.
Maltese: L-opinjoni finali ġiet mibdula f'Deċiżjoni mill-Kummissjoni Ewropea fid-6 ta' Settembru 2013.
English: Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to changes of the product information related to harmonisation of the withdrawal periods, inclusion of warning sentences concerning the use in dairy animals and environmental risk mitigation measures.
Maltese: Abbażi tal-evalwazzjoni tad-dejta disponibbli attwalment, is-CVMP ikkunsidra li l-profil tal-benefiċċju u r-riskju għal dawn il-prodotti baqa' wieħed pożittiv soġġett għal bidliet fl-informazzjoni dwar il-prodott relatata mal-armonizzazzjoni tal-perjodi ta' tiżmim, inkluż is-sentenzi ta' twissija dwar l-użu fl-annimali li jipproduċu l-ħalib miżuri ta' mitigazzjoni ambjentali.
English: ≥ 2 points on a 0-4 IGA scale.
Maltese: punti fuq skala IGA 0-4.
English: Regeneron Ireland Unlimited Company (U.C.)
Maltese: Regeneron Ireland Unlimited Company (U.C.) Ballycummin
English: PRO Treatment
Maltese: PRO Trattament
English: The injection can take up to 20 seconds.
Maltese: L-injezzjoni tista' tieħu sa 20 sekonda.
English: Life Quality Index (CDLQI) was 13.6.
Maltese: Dermatology Life Quality Index) kien ta' 13.6.
English: Step 4: Wait 45 minutes
Maltese: Pass 4: Stenna 45 minuta
English: Eczema herpeticum
Maltese: Ekżema herpeticum
English: Industriepark Hoechst 65926 FRANKFURT AM MAIN GERMANY
Maltese: Industriepark Hoechst 65926 FRANKFURT AM
English: SANOFI WINTHROP INDUSTRIE 1051 Boulevard Industriel, 76580 LE TRAIT, FRANCE
Maltese: SANOFI WINTHROP INDUSTRIE 1051 Boulevard Industriel, 76580 LE TRAIT, FRANZA
English: Placebo 232 0.18 (12.4) Dupilumab
Maltese: Plaċebo 232 0.18 (12.4) Dupilumab
English: Placebo 127 0.09 (4.36) QUEST study
Maltese: Plaċebo 127 0.09 (4.36) Studju QUEST
English: Parasitic (intestinal parasites) infection
Maltese: Infezzjoni b'parassiti (parassiti intestinali)
English: SANOFI BULGARIA EOOD Тел.
Maltese: SANOFI BULGARIA EOOD
English: A: Prepare A1.
Maltese: Ipprepara A1.
English: Step 4: Wait 30 minutes
Maltese: Pass 4: Stenna 30 minuta
English: • a puncture-resistant container* (See Step 12)
Maltese: • kontenitur li ma jittaqqabx* (Ara Pass 12)
English: 2 years.
Maltese: 2 snin.
English: Mean age (years) (SD) % Female % White
Maltese: Età medja (snin) (SD) % Nisa % Bojod
English: Adolescents
Maltese: Adolexxenti
English: Note: You may see an air bubble; this is normal.
Maltese: Nota: Tista' tara bużżieqa tal-arja; dan huwa normali.
English: Step 8: Pinch
Maltese: Pass 8: Oqros
English: Name and address of the manufacturer(s) responsible for batch release SANOFI WINTHROP INDUSTRIE 1051 Boulevard Industriel,
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott SANOFI WINTHROP INDUSTRIE 1051 Boulevard Industriel,
English: Sanofi Belgium
Maltese: Sanofi Malta
English: Treatment-emergent ADA: QW: 1.2%; Q2W: 4.3%; Q4W: 6.0%; Q8W:
Maltese: QW: 1.2%; Q2W: 4.3%; Q4W: 6.0%; Q8W: 11.7%.
English: Dupilumab 200 mg (<60 kg) and
Maltese: Dupilumab 200 mg (<60 kg) u
English: Endpoints
Maltese: Punti finali
English: Name and address of the manufacturer(s) of the biological active substance(s) REGENERON PHARMACEUTICALS INC.
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i) REGENERON PHARMACEUTICALS INC.
English: Maintenance and Durability of Response (SOLO CONTINUE study)
Maltese: Manteniment u Tul tar-Rispons (studju SOLO CONTINUE)
English: The data gathered from this study did not indicate clinically relevant effects of dupilumab on CYP1A2, CYP3A, CYP2C19, CYP2D6, or CYP2C9 activity.
Maltese: Id-data miġbura minn dan l-istudju ma indikatx effetti klinikament rilevanti ta' dupilumab fuq l-attività ta' CYP1A2, CYP3A, CYP2C19, CYP2D6, jew CYP2C9.
English: Conjunctivitis Oral herpes
Maltese: Herpes orali
English: • a puncture-resistant container* (See Step D)
Maltese: • kontenitur li ma jittaqqabx* (Ara Pass D)
English: Placebo N=69
Maltese: Plaċebo N=69
English: Dupixent contains sodium
Maltese: Dupixent fih sodium
English: LS = least squares; SE= standard error a Full analysis set (FAS) includes all patients randomized.
Maltese: LS = least squares; SE= standard error a Sett ta' Analiżi Kompluta (FAS - full analysis set) jinkludi l-pazjenti kollha randomised.
English: Pruritus NRS (>4-point improvement), % respondersc
Maltese: Pruritus NRS (>4-punti ta' titjib), % li rrispondewc c
English: N LS Mean Δ
Maltese: N Medja ta' LS Δ
English: Placebo N=41
Maltese: Plaċebo N=41
English: IGA 0 or 1b, % respondersc
Maltese: IGA 0 jew 1b, % li rrispondewc
English: Placebo N=57
Maltese: Plaċebo N=57
English: 60 kg or more
Maltese: 60 kg jew iżjed
English: ADA responses lasting more than 12 weeks: QW: 0.0%; Q2W: 1.4%; Q4W: 0.0%; Q8W:
Maltese: QW: 0.0%; Q2W: 1.4%; Q4W: 0.0%; Q8W: 2.6%.
English: DRI12544 was a 24-week dose-ranging study which included 776 patients (18 years of age and older).
Maltese: DRI12544 kien studju ta' 24 ġimgħa ta' ttestjar ta' firxa ta' dożi li inkluda 776 pazjent (età ta' 18-il sena u aktar).
English: Week 16 (FAS)b
Maltese: Ġimgħa 16 (FAS)b
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients arginine hydrochloride histidine polysorbate 80 sodium acetate trihydrate glacial acetic acid sucrose water for injections
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti arginine hydrochloride histidine polysorbate 80 sodium acetate trihydrate glacial acetic acid sucrose ilma għall-injezzjonijiet
English: Genzyme Flanders BVBA Cipalstraat 8, B-2440 Geel
Maltese: Genzyme Flanders BVBA Cipalstraat 8
English: In a clinical study of AD patients, the effects of dupilumab on the pharmacokinetics (PK) of CYP substrates were evaluated.
Maltese: Fi studju kliniku ta' pazjenti b'AD, ġew evalwati l-effetti ta' dupilumab fuq il-farmakokinetika (PK) ta' sottostrati ta' CYP.
English: CDLQI, (≥6-point improvement), % responders POEM, LS mean change from baseline (+/- SE)
Maltese: CDLQI, (≥6- punti ta' titjib), % li rrispondew POEM, LS bidla medja mil-linja bażi (+/- SE)
English: A reduction of lactate dehydrogenase (LDH), a biomarker associated with AD disease activity and severity, was observed with dupilumab treatment.
Maltese: Kien osservat tnaqqis ta' lactate dehydrogenase (LDH), biomarkatur assoċjat mal-attività u s-severità tal-marda ta' AD, bi trattament ta' dupilumab.
English: Step 12: Dispose
Maltese: Pass 12: Armi
English: C5.
Maltese: Ċ5.
English: CHRONOS enrolled 740 patients (315 to placebo + topical corticosteroid (TCS), 106 to dupilumab 300 mg Q2W + TCS, and 319 to dupilumab 300 mg QW + TCS) and had a treatment period of 52 weeks.
Maltese: CHRONOS irreġistra 740 pazjent (315 għal plaċebo + kortikosterojdi topiċi (TCS - topical corticosteroid), 106 għal dupilumab 300 mg Q2W + TCS, u 319 għal dupilumab 300 mg QW + TCS) u kellu perjodu ta' trattament ta' 52 ġimgħa.
English: Open here
Maltese: OĦRA TAL
English: A total of 2,888 adult and adolescent patients with moderate-to-severe asthma were evaluated in 3 randomised, placebo-controlled, multicentre trials of 24 to 52 weeks duration (DRI12544, QUEST, and VENTURE).
Maltese: Total ta' 2,888 pazjent adult u adolexxenti b'ażżma minn moderata sa severa ġew evalwati fi tliet studji b'ħafna ċentri, arbitrarji, kkontrollati bi laċebo li damu minn 24 sa 52 ġimgħa (DRI12544, QUEST, u VENTURE).
English: Placebo + TCS
Maltese: Plaċebo + TCS
English: Table 8: Additional secondary endpoint results of dupilumab monotherapy at Week 16
Maltese: Tabella 8: Riżultati ta' punti finali sekondarji addizjonali ta' monoterapija b'dupilumab f'Ġimgħa 16
English: The responder rate was defined as an improvement in score of 0.5 or more (scale range 0-6 for ACQ-5 and 1-7 for AQLQ(S)).
Maltese: Ir-rata ta' persuni li rrispondew ġiet definita bħala titjib fil-punteġġ ta' 0.5 jew aktar (skala fuq firxa ta' 0-6 għal ACQ-5 u 1-7 għal AQLQ(S)).
English: QUEST was a 52-week confirmatory study which included 1,902 patients (12 years of age and older).
Maltese: QUEST kien studju konfermatorju ta' 52 ġimgħa li kien jinkludi 1,902 pazjenti (età ta' 12-il sena u aktar).
English: The absolute bioavailability of dupilumab following a SC dose is similar between AD and asthma patients, ranging between 61% and 64 %, as determined by a population pharmacokinetics (PK) analysis.
Maltese: Il-bijodisponibilità assoluta ta' dupilumab wara doża SC tixxiebah bejn pazjenti b'AD u bl-ażżma, li tvarja bejn 61% u 64 %, kif determinat minn analiżi tal-farmakokinetika (PK - pharmakokinetics) tal-popolazzjoni.
English: Week 52 (FAS Week 52)b
Maltese: Ġimgħa 52 (FAS Ġimgħa 52)b
English: Pharmacotherapeutic group: Other dermatological preparations, agents for dermatitis, excluding corticosteroids, ATC code: D11AH05
Maltese: Kategorija farmakoterapewtika: Preparazzjonijiet dermatoloġiċi oħra, sustanzi għad-dermatite, li mhumiex kortikosterojdi, Kodiċi ATC:
English: Elderly patients (≥ 65 years)
Maltese: Pazjenti anzjani (≥65 sena)
English: Very rarely, Dupixent can cause serious side effects, including allergic (hypersensitivity) reactions and anaphylactic reaction.
Maltese: Rari ħafna, Dupixent jista' jikkawża effetti sekondarji serji, inklużi reazzjonijiet allerġiċi (sensittività eċċessiva) u reazzjoni anafilattika.
English: Treatment-emergent eosinophilia (≥ 5,000 cells/mcL) was reported in < 2 % of dupilumab-treated patients and < 0.5 % in placebo-treated patients.
Maltese: Eosinofilja li feġġet minħabba t-trattament (≥ 5,000 ċellula/mcL) ġiet irrappurtata f'< 2 % tal-pazjenti ttrattati b'dupilumab u < 0.5 % f'pazjenti ttrattati bi plaċebo.
English: N Responder rate (%)
Maltese: L (%)
English: - The active substance is dupilumab.
Maltese: - Is-sustanza attiva hi dupilumab.
English: Dupilumab inhibits IL-4 signaling via the Type I receptor (IL-4Rα/γc), and both IL-4 and IL-13 signaling through the Type II receptor (IL-4Rα/IL-13Rα).
Maltese: Dupilumab jinibixxi s-sinjalar ta' IL-4 permezz tar-riċettur tat-Tip I (IL-4Rα/γc), u ssinjalar ta' IL-4 kif ukoll ta' IL-13 permezz tar-riċettur tat-Tip II (IL-4Rα/IL-13Rα).
English: Table 6: Results of the primary and secondary endpoints in CAFE study Placebo + TCS
Maltese: Tabella 6: Riżultati tal-punti finali primarji u sekondarji fl-istudju CAFÉ
English: Placebo ap-value = 0.0003, bp-value = 0.0001, cp-value = 0.0116, dp-value = 0.0024, ep-value <0.0001
Maltese: Plaċebo avalur p = 0.0003, bvalur p = 0.0001, cvalur p = 0.0116, dvalur p = 0.0024, evalur p <0.
English: Across clinical trials, the mean ±SD steady-state trough concentrations ranged from 60.3±35.1 mcg/mL to 79.9±41.4 mcg/mL for 300 mg dose and from 29.2±18.7 to 36.5±22.2 mcg/mL for 200 mg dose administered every other week.
Maltese: Tul il-provi kliniċi, il-medja ±SD tal-konċentrazzjonijiet l-aktar baxxi fi stat fiss varjat minn 60.3±35.1 mcg/mL u minn 29.2±18.7 sa 36.5±22.2 mcg/mL għad-doża ta' 200 mg mogħtija darba kull ġimagħtejn.
English: Treatment effects in subgroups (weight, age, gender, race, and background treatment, including immunosuppressants) in SOLO 1 and SOLO 2 were consistent with the results in the overall study population.
Maltese: L-effetti tat-trattamenti f'sottogruppi (piż, età, sess, razza, u trattament ieħor fl-istess waqt, inklużi immunosoppressanti) f'SOLO 1 u SOLO 2 kienu konsistenti mar-riżultati fil-popolazzjoni globali talistudju.
English: N Responder rate %
Maltese: Rata ta' Persuni li Rrisponde w %
English: Dupixent 300 mg injection dupilumab
Maltese: Dupixent 300 mg injezzjoni dupilumab
English: Dupixent 200 mg injection dupilumab
Maltese: Dupixent 200 mg injezzjoni dupilumab
English: Treatment effects in subgroups (weight, age, gender, race, and background treatment, including immunosuppressants) in CHRONOS were consistent with the results in the overall study population.
Maltese: L-effetti ta' trattamenti f'sottogruppi (piż, età, sess, razza, u trattament ieħor fl-istess waqt, inklużi immunosoppressanti) fi CHRONOS kienu konsistenti mar-riżultati fil-popolazzjoni globali tal-istudju.
English: In DRI12544 and QUEST, the pre-specified subgroup analyses included blood eosinophils ≥ 150 and ≥ 300 cells/mcL, FeNO ≥ 25 and ≥ 50 ppb.
Maltese: F'DRI12544 u QUEST, l-analiżi speċifikati minn qabel ta' sottogrupp kienu jinkludu eosinofili fid-demm ≥ 150 u ≥ 300 ċelluli/mcL, FeNO ≥ 25 u ≥ 50 ppb.
English: SOLO 1 enrolled 671 patients (224 to placebo, 224 to dupilumab 300 mg Q2W, and 223 to dupilumab 300 mg QW) and had a treatment period of 16 weeks.
Maltese: SOLO 1 irreġistra 671 pazjent (224 għall-plaċebo, 224 għal dupilumab t 300 mg Q2W, u 223 għal dupilumab 300 mg QW) u kellu perjodu ta' trattament ta' 16-il ġimgħa.
English: • There will be a “click” when the injection starts.
Maltese: • Se jkun hemm “klikk” meta l-injezzjoni tibda..
English: D. Dispose
Maltese: D: Armi
English: Other medicines and Dupixent
Maltese: Mediċini oħra u Dupixent
English: Date of first authorisation: 26 September 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 26 ta' Settembru 2017
English: Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with dupilumab.
Maltese: Immunoġeniċità Bħal ma' bil-proteini terapewtiċi kollha, hemm potenzjal ta' immunoġeniċità b'dupilumab.
English: The safety of dupilumab was assessed in a study of 250 patients 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD-1526).
Maltese: Is-sigurtà ta' dupilumab ġiet evalwata f'studju ta' 250 pazjent ta' età minn 12 sa 17-il sena b'dermatite atopika moderata għal severa (AD-1526).
English: Do not store above 25°C.
Maltese: 25°C.
English: The most common adverse reactions were injection site reactions, conjunctivitis, blepharitis, and oral herpes.
Maltese: L-aktar reazzjonijiet avversi komuni kienu reazzjonijiet fil-post tal-injezzjoni, konġuntivite, blefarite, u herpes orali.
English: The medium ICS dose was defined as equal to 500 mcg fluticasone or equivalent per day.
Maltese: Iddoża medja ta' ICS ġiet definita bħala ugwali għal 500 mcg fluticasone jew ekwivalenti kuljum.
English: In atopic dermatitis clinical trials, treatment with dupilumab was associated with decreases from baseline in concentrations of type 2 immunity biomarkers, such as thymus and activation-regulated chemokine (TARC/CCL17), total serum IgE and allergen-specific IgE in serum.
Maltese: Fi provi kliniċi tad-dermatite atopika, trattament b'dupilumab kien assoċjat ma' tnaqqis mil-linja bażi fil-konċentrazzjonijiet ta' bijomarkaturi tal-immunità tat-tip 2, bħal kimokina regolata mit-timu u minn attivazzjoni (TARC - thymus and activation-regulated chemokine/CCL17), IgE totali fis-serum u IgE speċifika għall-allerġeni fis-serum.
English: Endpoints were assessed at weeks 51 or 52.
Maltese: Il-punti finali kienu evalwati f'ġimgħat 51 jew 52.
English: Conjunctivitis related events
Maltese: Avvenimenti relatati mal-konġuntivite
English: 16-Week Monotherapy Studies (SOLO 1 and SOLO 2)
Maltese: Studji ta' Monoterapija (SOLO 1 u SOLO 2) ta' 16-il Ġimgħa
English: Figure 1: Mean percent change from baseline in EASI in SOLO 1a and SOLO 2a (FAS)b
Maltese: Figura 1: Bidla perċentwali medja mil-linja bażi f'EASI f'SOLO 1a u SOLO 2a (FAS)b
English: In the concomitant TCS study (CHRONOS), across all treatment groups, the mean age was 37.1, the mean weight was 74.5 kg, 39.7 % were female, 66.2 % were white, 27.2 % were Asian, and 4.6 % were black.
Maltese: Fl-istudju ta' TCS konkomitanti (CHRONOS), fil-gruppi kollha ta' trattament, l-età medja kienet 37.1, il-piż medju kien 74.5 kg, 39.7 % kienu nisa, 66.2 % kienu bojod, 27.2 % kienu Asjatiċi, u 4.6 %
English: N Rate (95% CI)
Maltese: N Rata (95% CI)
English: Dupilumab is a monoclonal antibody (a type of specialised protein) that blocks the action of proteins called IL-4 and IL-13.
Maltese: Dupilumab huwa antikorp monoklonali (tip ta' proteina speċjalizzata) li jimblokka l-azzjoni ta' proteini msejħa IL-4 u IL-13.
English: Clinical efficacy and safety in atopic dermatitis
Maltese: Effikaċja klinika u sigurtà fid-dermatite atopika
English: LS = least squares; SE = standard error a p-value < 0.0001 b p-value < 0.001 c p-value < 0.05
Maltese: SE = standard error a valur p < 0.0001 b valur p < 0.001 c valur p < 0.05