FrancophonIA/ELRC3.0 huggingface dataset:
English: Retacrit is a ‘biosimilar' medicine.
Maltese: Retacrit huwa mediċina ‘bijosimili'.
English: It is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin zeta.
Maltese: Dan huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': hija magħmula minn ċellola li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l-epoetina zeta.
English: Retacrit was studied to show that it is comparable with the reference medicine, Eprex/Erypo, in experimental models and in humans.
Maltese: Retacrit ġie studjat biex juri li hu komparabbli mal-mediċina ta' referenza, Eprex/Erypo, f'mudelli sperimentali u fil-bniedem.
English: This document is a summary of the European Public Assessment Report (EPAR) for Retacrit.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Retacrit.
English: Therefore, the CHMP's view was that, as for Eprex/Erypo, the benefit outweighs the identified risks.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal f'Eprex/Erypo, il-benefiċċju huwa akbar mir-riskji identifikati.
English: Retacrit, injected into a vein, was compared with the reference medicine in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a technique for removing waste products from the blood).
Maltese: Retacrit, injettat fil-vina, ġie mqabbel mal-mediċina ta' referenza f'żewġ studji ewlenin li involvew 922 pazjent li kienu jbatu minn anemija assoċjata ma' insuffiċjenza kronika renali li kienu jeħtieġu emodijaliżi (teknika għat-tneħħija ta' prodotti ta' skart mid-demm).
English: The CHMP concluded that, in accordance with EU requirements, Retacrit has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
Maltese: Is-CHMP kkunsidra li, f'konformità mar-rekwiżiti tal-UE, Retacrit wera li għandu kwalità, sigurtà u effikaċja komparabbli ma' dawk ta' Eprex/Erypo.
English: For patients with chronic renal failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children).
Maltese: Fil-pazjenti li qegħdin ibatu minn mard kroniku renali jew li qed jirċievu l-kemoterapija, il-livelli talemoglobina għandhom jibqgħu l-istess u jżommu mar-rakkomandazzjoni varjabbli (bejn 10 grammi u 12-il gramma għal kull deċilitru fl-adulti u bejn 9.5 u 11 g/dl fit-tfal).
English: The company also presented the results of two studies looking at the effects of Retacrit injected under the skin: one involved 261 cancer patients receiving chemotherapy, and the other compared Retacrit with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' żewġ studju li jħarsu lejn l-effetti ta' Retacrit injettat taħt il-ġilda: wieħed involva '261 pazjent bil-kanċer li kienu qed jieħdu l-kemjoterapija u l-ieħor qabbel Retacrit ma' Eprex/Erypo f'462 pazjent bl-anemija kkawżata minn problemi fil-kliewi.
English: In the study of patients already being treated with an epoetin, haemoglobin levels were maintained at around 11.4 g/dl when the patients were receiving Retacrit and when they were receiving Eprex/Erypo.
Maltese: Fl-istudju ta' pazjenti li diġà kienu qed jingħataw epoetina, il-livelli tal-emoglobina nżammu għal madwar 11.4 g/dl meta l-pazjenti kienu qed jirċievu Retacrit u Eprex/Erypo.
English: The European Commission granted a marketing authorisation valid throughout the EU for Retacrit on 18 December 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Retacrit fit-18 ta' Diċembru 2007.
English: What is Retacrit?
Maltese: X'inhu Retacrit?
English: This means that Retacrit is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU), and contains a similar active substance to the reference medicine.
Maltese: Dan ifisser li Retacrit huwa simili għal mediċina bijoloġika li hija diġà awtorizzata fl-Unjoni Ewropea (UE) u li tinkludi l-istess sustanza attiva (magħrufa bħala ‘mediċina ta' referenza').
English: Retacrit was also as effective as the reference medicine in patients with kidney problems.
Maltese: Retacrit kien effikaċi wkoll bl-istess mod bħala mediċina ta' referenza f'pazjenti bi problemi tal-kliewi.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
Maltese: • it-trattament tal-anemija (nuqqas ta' ċelloli ħomor tad-demm) li fil-pazjenti qed tikkawża sintomi b''nuqqas kroniku renali' (tnaqqis progressiv u fit-tul fl-abbiltà tal-kliewi biex jaħdmu sew) jew problemi oħra fil-kliewi;
English: The active substance in Retacrit, epoetin zeta, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
Maltese: Is-sustanza attiva f'Retacrit, epoetina zeta, hija kopja tal-eritropojetina umana u taħdem bl-istess manjiera tal-ormon naturali sabiex tistimula l-produzzjoni taċ-ċelloli ħomor fid-demm.
English: The reference medicine for Retacrit is Eprex/Erypo, which contains epoetin alfa.
Maltese: Il-mediċina ta' referenza għal Retacrit hija Eprex/Erypo, li fiha l-epoetin alfa.
English: In the correction study, haemoglobin levels were around 11.6 g/dl during the last four weeks of the study, having risen from around 8.0 g/dl before treatment.
Maltese: Flistudju tal-korrezzjoni, il-livelli tal-emoglobina kienu madwar 11.6 g/dl waqt l-aħħar erba' ġimgħat talistudju, wara li żdied minn madwar 8.0 g/dl qabel it-trattament.
English: • to reduce the need for blood transfusions in patients with moderate anaemia about to undergo major bone surgery (such as a hip or knee replacement).
Maltese: • sabiex tonqos il-ħtieġa għal trasfużjonijiet tad-demm f'pazjenti li jbatu b'anemija moderata li waslu għal intervent kirurġiku (bħas-sostituzzjoni tal-irkoppa u l-ġenb).
English: What is the risk associated with Retacrit?
Maltese: X'inhu r-riskju assoċjat ma' Retacrit?
English: It must not be used in patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin, patients with hypertension (high blood pressure) that is not controlled, patients about to undergo surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke, or patients who cannot receive medicines to prevent blood clots.
Maltese: Retacrit ma għandux jintuża minn persuni li żviluppaw aplasija pura taċ-ċelloli tad-demm ħomor (tnaqqis jew twaqqif tal-produzzjoni taċ-ċelloli tad-demm ħomor) wara t-trattament bi xi eritropoietina, pazjenti bi pressjoni għolja li ma tkunx kontrollata, pazjenti li jkunu waslu biex jiġu operati li jkollhom problemi kardjovaskulari (fil-qalb u fl-arterji u l-vini) attakk tal-qalb jew puplesija reċenti, jew pazjenti li ma jistgħux jirċievu mediċini biex jipprevjenu l-emboli tad-demm.
English: For patients receiving chemotherapy, it must be injected under the skin, and for patients about to undergo surgery, it must be injected into a vein.
Maltese: Fil-pazjenti li qed jingħataw il-kemoterapija, din il-mediċina trid tiġi injettata taħt il-ġilda, u fil-pazjenti li ser jagħmlu intervent kirurġiku, il-mediċina tiġi injettata fil-vina.
English: Why has Retacrit been approved?
Maltese: Għaliex ġie approvat Retacrit?
English: The study in patients receiving chemotherapy showed that Retacrit brought about similar improvements in haemoglobin levels as those reported in the scientific literature for other epoetins.
Maltese: L-istudju f'pazjenti li jirċievu kemoterapija wera li Retacrit ġab titjib simili fil-livelli ta' emoglobina bħal dawk rappurtati fil-letteratura xjentifika ta' epoetini oħra.
English: How has Retacrit been studied?
Maltese: Kif ġie studjat Retacrit?
English: For the full list of all side effects reported with Retacrit, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrapportati b'Retacrit, ara lFuljett ta' Tagħrif.
English: The first study compared the effects of Retacrit with those of Eprex/Erypo in correcting red blood cell counts in 609 patients over 24 weeks.
Maltese: L-ewwel studju qabbel l-effetti ta' Retacrit ma' dawk ta' Eprex/Erypo fil-korrezzjoni ta' għadd ta' ċelloli ħomor f'609 pazjenti fuq medda ta' 24 ġimgħa.
English: Retacrit can also lead to skin rash and influenza (flu)-like symptoms.
Maltese: Retacrit jista' jwassal għal raxx filġilda u sintomi jixbhu lill-influwenza.
English: • to treat anaemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions;
Maltese: • it-trattament tal-anemija fl-adulti li jkunu qed jingħataw il-kemoterapija għal ċerti tipi ta' kanċer u sabiex titnaqqas il-ħtieġa għat-trasfużjonijiet tad-demm;
English: The full EPAR and risk management plan summary for Rixubis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Rixubis
Maltese: Informazzjoni oħra dwar Rixubis
English: In the first study, involving 73 patients aged 12 to 59 years, 249 bleeding episodes were treated with Rixubis.
Maltese: Fl-ewwel studju, li involva 73 pazjent ta' bejn 12 u 59 sena, 249 episodju ta' fsada ġew ikkurati b'Rixubis.
English: Rixubis contains the active substance nonacog gamma.
Maltese: Rixubis fih is-sustanza attiva nonacog gamma.
English: A second study involved 23 children aged from just under 2 to nearly 12 years of age, who experienced 26 bleeding episodes during the study: treatment of bleeding episodes was rated as excellent in 50% of cases and good in another 46%, and the average bleeding rate was reduced from 6.8 to 2.7 bleeds per year.
Maltese: It-tieni studju involva 23 tifel u tifla minn ftit taħt is-sentejn sa 12-il sena, li esperjenzaw 26 episodju ta' fsada waqt l-istudju: il-kura tal-episodji ta‘ fsada ġiet ikklassifikata bħala eċċellenti f'50% tal-każijiet u tajjeb fis-46% l-oħrajn, u r-rata medja tal-fsada tnaqqset minn 6.8 għal 2.7 fsada kull sena.
English: Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations.
Maltese: Reazzjonijiet ta' ipersensittività (allerġiċi) jistgħu jseħħu b'mod rari, u jistgħu jinkludu anġjoedema (nefħa tat-tessuti ta' taħt il-ġilda), ħruq u tingiż fis-sit tal-injezzjoni, tertir, fwawar, raxx bil-ħakk, uġigħ ta' ras, urtikarja, ipotensjoni (pressjoni baxxa), għejja jew irrekwitezza, dardir (tħossok ma tiflaħx) jew rimettar, takikardija (taħbit tal-qalb mgħaġġel), għafis fis-sider, tħarħir u sensazzjonijiet ta' tingiż.
English: This is a summary of the European public assessment report (EPAR) for Rixubis.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rixubis.
English: Why is Rixubis approved?
Maltese: Għaliex ġie approvat Rixubis?
English: Nonacog gamma is not extracted from human blood but is made by a method known as ‘recombinant DNA technology': it is made by hamster cells into which a gene (DNA) has been introduced that makes the cells able to produce the human clotting factor.
Maltese: Nonacog gamma ma jiġix estratt mid-demm tal-bniedem iżda jsir b'metodu magħruf bħala ”teknoloġija ta' DNA rekombinanti”: isir minn ċelloli tal-ħamsters li fihom jiġi introdott ġene (DNA) li jagħmel iċċelloli kapaċi jipproduċu l-fattur tal-għaqid tad-demm tal-bniedem.
English: This lack causes blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Maltese: Dan in-nuqqas jikkawża problemi fl-għaqid tad-demm, bħal fsada fil-ġogi, fil-muskoli jew fl-organi interni.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rixubis on 19 December 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rixubis fit-19 ta' Diċembru 2014.
English: The effect of treatment in stopping bleeding episodes was rated excellent in 41% of cases and good in a further 55%.
Maltese: L-effett tal-kura fit-twaqqif tal-episodji tal-fsada kien ikklassifikat bħala eċċellenti f'41% talkażijiet u tajjeb f'55% oħrajn.
English: The Committee considered that Rixubis had been shown to be effective in preventing and treating bleeding episodes in adults and children with haemophilia B, and was also effective in allowing them to undergo surgery safely.
Maltese: Il-Kumitat ikkunsidra li Rixubis intwera li huwa effettiv fil-prevenzjoni u fil-kura ta' episodji ta' fsada f'adulti u tfal b'emofilja B, u kien effettiv ukoll f'li jippermetti li jsirilhom intervent kirurġiku sigur.
English: With respect to prevention of bleeding, the average bleeding rate during treatment was 4.26 bleeds a year, compared with an average of about 17 per year before enrolment.
Maltese: Fir-rigward tal-prevenzjoni tal-fsada, ir-rata medja ta' fsada waqt il-kura kienet 4.26 fsada kull sena, meta mqabbel ma' medja ta' madwar 17-il fsada kull sena qabel irreġistrazzjoni.
English: What are the risks associated with Rixubis?
Maltese: X'inhuma r-riskji assoċjati ma' Rixubis?
English: The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs.
Maltese: L-effetti sekondarji l-aktar komuni b'Rixubis (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma disgewsja (disturbi fit-togħma) u uġigħ fir-riġlejn u d-dirgħajn.
English: For further information, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal iktar informazzjoni, ara s-sommarju tal-karatteristiċi talprodott (parti wkoll mill-EPAR).
English: Rixubis is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of factor IX.
Maltese: Rixubis huwa mediċina li tintuża fil-kura u fil-prevenzjoni ta' fsada f'pazjenti b'emofilja B, disturb ereditarju bi fsada kkawżat min-nuqqas ta' fattur IX.
English: In a third study, Rixubis was given to 14 patients undergoing surgery; treatment with Rixubis kept blood loss during the surgery to levels expected in patients without haemophilia B.
Maltese: Fit-tielet studju, Rixubis ingħata lil 14-il pazjent li kienu qegħdin jagħmlu intervent kirurġiku; kura b'Rixubis żammet it-telf tad-demm waqt il-kirurġija f'livelli mistennija f'pazjenti mingħajr emofilja B.
English: Rixubis is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Maltese: Rixubis huwa disponibbli bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni ġo vina.
English: The active substance in Rixubis, nonacog gamma, is a version of human factor IX and helps the blood to clot in the same way.
Maltese: Is-sustanza attiva f'Rixubis, nonacog gamma, hija verżjoni tal-fattur IX tal-bniedem u tgħin sabiex id-demm jagħqad bl-istess mod.
English: How is Rixubis used?
Maltese: Kif jaħdem Rixubis?
English: For the full list of all side effects with Rixubis see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Rixubis ara l-fuljett ta' tagħrif.
English: The benefits of Rixubis in treating and preventing bleeding episodes have been shown in three main studies involving patients with severe or moderately severe haemophilia B. None of the studies compared the effectiveness of Rixubis directly with another medicine.
Maltese: Il-benefiċċji ta' Rixubis fil-kura u l-prevenzjoni ta' episodji ta' fsada ntwerew fi tliet studji ewlenin li involvew pazjenti b'emofilja B severa jew moderatament severa.
English: The evaluation of these studies also indicated that Rixubis was distributed in the body similarly to another approved factor IX product.
Maltese: L-evalwazzjoni ta' dawn l-istudji indikat ukoll li Rixubis infirex fil-ġisem b'mod simili għal prodott ieħor tal-fattur IX approvat.
English: A risk management plan has been developed to ensure that Rixubis is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Rixubis jintuża bl-aktar mod sigur possibbli.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rixubis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Rixubis huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: 1 F. Peyvandi et al. “A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A” N Engl J Med. 2016 May
Maltese: 1 F. Peyvandi et al. “A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A” N Engl J Med. 2016
English: T, Mauser-Bunschoten E, Mingot-Castellano ME0, Ozdemir N1, Pabinger I, Parra R1, Pasi J, Peerlinck K, Rauch A6, RousselRobert V, Serban M, Tagliaferri A, Windyga J, Zanon E: Natural history and clinical characteristics of inhibitors in previously treated haemophilia A patients: a case series.
Maltese: T, Mauser-Bunschoten E, Mingot-Castellano ME0, Ozdemir N1, Pabinger I, Parra R1, Pasi J, Peerlinck K, Rauch A6, RousselRobert V, Serban M, Tagliaferri A, Windyga J, Zanon E:
English: - http://www.bloodjournal.org/content/121/20/4046.full.pdf
Maltese: Engl J Med 2013; 368: 231-9. - http://www.bloodjournal.org/content/121/20/4046.full.pdf
English: 2015 May;113(5):968-75. doi: 10.1160/TH14-100826.
Maltese: May;113(5):968-75. doi: 10.
English: For high-titre inhibitors, the hazard ratio was 1.69 (95% CI, 0.96 to 2.98).
Maltese: Għall-inibituri ta' titre għoli, il-proporzjon ta' riskju kien 1.69 (CI ta' 95%, 0.96 sa 2.98).
English: • Patient-related risk factors include type of F8 gene mutation, severity of haemophilia, ethnicity, family history of inhibitor development and possibly HLA-DR (Human Leukocyte Antigenantigen D Related) constitution.
Maltese: • Fatturi ta' riskju relatati mal-pazjent jinkludu t-tip ta' mutazzjoni tal-ġene F8, is-severità talemofilja, l-etniċità, storja familjari ta' żvilupp tal-inibituri u possibbilment il-kostituzzjoni ta' HLA-DR (Antiġen Lewkoċitarju tal-Bniedem - Relatat ma' antiġen D, Human Leukocyte Antigen - antigen D Related).
English: MAH-sponsored studies
Maltese: Studji sponsorjati minn MAH
English: The PRAC adopted a recommendation on 01 September 2017 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Fl-1 ta' Settembru 2017, il-PRAC adotta rakkomandazzjoni li dak iż-żmien ġiet ikkunsidrata mis-CHMP, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for human plasma derived and recombinant coagulation factor VIII containing medicinal products (see Annex I and Annex A).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE li tirriżulta minn dejta ta' farmakoviġilanza, għall-prodotti mediċinali li fihom il-fattur ta' koagulazzjoni VIII talbniedem derivat mill-plażma u rikombinanti (ara Anness I u Anness A).
English: The CANAL study2 found no evidence of a class difference, including pdFVIII products with considerable quantities of von Willebrand factor; for ‘clinically relevant' inhibitors the adjusted hazard ratio was 0.7 (95% CI 0.4-1.1), and for high titre inhibitors (≥5 BU) was 0.8 (95% CI 0.4-1.3).
Maltese: L-istudju CANAL2 ma sab l-ebda evidenza ta' differenza fil-klassi, inkluż prodotti pdFVIII bi kwantitajiet konsiderevoli tal-fattur von Willebrandl; għall-inibituri “klinikament relevanti” il-proporzjon ta' riskju aġġustat kien ta' 0.7 (95% CI 0.4-1.1), u għall-inibituri ta' titre għoli (≥5 BU) kien ta' 0.8 (95% CI
English: Having considered the abovementioned results from SIPPET, the published literature and all the information submitted by the MAHs, as well as the views expressed by experts expressed at the ad-hoc expert meeting, the PRAC concluded that:
Maltese: Meta jiġu kkunsidrati r-riżultati ta' hawn fuq minn SIPPET, il-letteratura ppublikata u l-informazzjoni kollha ppreżentata mill-MAHs, kif ukoll il-fehmiet espressi mill-esperti fil-laqgħa ta' esperti ad hoc, ilPRAC ikkonkluda li:
English: In Cox regression models for the primary end point of all inhibitors, rFVIII was associated with an 87% higher incidence than pdFVIII (hazard ratio, 1.87; 95% CI, 1.17 to 2.96).
Maltese: F'mudelli ta' rigressjoni Cox għall-end-point primarju tal-inibituri kollha, rFVIII ġie assoċjat ma' inċidenza ogħla ta' 87 % milli pdFVIII (proporzjon ta' riskju, 1.87; CI ta' 95%, 1.17 sa 2.96).
English: Similar to RODIN/Pednet, the UKHCDO study found a significant increased risk of inhibitors (all and high titre) for Kogenate FS/Helixate NexGen (2nd generation rFVIII) compared to Advate (3rd generation rFVIII).
Maltese: Simili għal RODIN/Pednet, l-istudju UKHCDO sab riskju miżjud sinifikanti ta' inibituri (kollha u ta' titre għoli) għal Kogenate FS/Helixate NexGen (rFVIII tat-2ni ġenerazzjoni) meta mqabbel ma' Advate (rFVIII tat-3et ġenerazzjoni).
English: The pdFVIII class consists of products with or without Von Willebrand Factor (VWF), and those with VWF contain a range of VWF levels.
Maltese: Il-klassi pdFVIII tikkonsisti minn prodotti bi jew mingħajr il-Fattur Von Willebrand (VWF, Von Willebrand Factor) u dawk b'VWF fihom medda ta' livelli VWF.
English: concentration<1%) with either the use of pdFVIII or rFVIII concentrates.
Maltese: FVIII derivat mill-plażma (pdFVIII) u rikombinanti (rFVIII).
English: • The PRAC considered the totality of the data submitted with regards to the risk of inhibitor development for the classes of recombinant and plasma derived FVIII products, in previously untreated patients (PUPs).
Maltese: • Il-PRAC ikkunsidra t-totalità tad-dejta ppreżentata fir-rigward tar-riskju ta' żvilupp tal-inibituri għall-klassijiet ta' prodotti FVIII rikombinanti u derivati mill-plażma, f'pazjenti li ġew ikkurati preċedentement (PUPs).
English: Although this could not have been prevented, an early termination of an open label trial raises the possibility of investigator bias and inflation of the probability of detecting an effect that is not present.
Maltese: Għalkemm dan ma setax jiġi evitat, terminazzjoni bikrija tal-prova open label tqajjem il-possibbiltà ta' preġudizzju talinvestigatur u żieda tal-probabbiltà li jiġi identifikat effett li mhuwiex preżenti.
English: The responses of MAHs referred to a range of published observational studies (the CANAL, RODIN, FranceCoag, UKHCDO, amongst others) which have sought to evaluate any differential risks of inhibitor development between the classes of pdFVIII and rFVIII, as well as any differential risk of inhibitor development between products within the rFVIII class.
Maltese: It-tweġibiet tal-MAHs irreferew għal medda ta' studji ta' osservazzjoni ppubblikati (il-CANAL, RODIN, FranceCoag, UKHCDO, fost oħrajn) li fittxew li jevalwaw kwalunkwe riskju differenzjali tal-iżvilupp talinibituri bejn il-klassijiet ta' pdFVIII u ta' rFVIII, kif ukoll kwalukwe riskju diferenzjali ta' żvilupp talinibituri bejn il-prodotti fil-klass rFVIII.
English: It found that patients treated with rFVIII products had an 87% higher incidence of all inhibitors than those treated with pdFVIII (which contained VWF) (hazard ratio, 1.87; 95% CI, 1.17 to 2.96).
Maltese: May pazjenti kkurati bi prodotti rFVIII kellhom inċidenza ogħla ta' 87 % tal-inibituri kollha minn dawk ikkurati b'pdFVIII (li kien fih VWF) (proporzjon ta' periklu, 1.87; 95% CI, 1.17 sa 2.96).