FrancophonIA/ELRC3.0 huggingface dataset:
English: During its 13-15 October 2009 meeting, the Committee agreed on a request from one marketing authorisation holder to provide an oral explanation to the CVMP which was subsequently withdrawn by the marketing authorisation holder.
Maltese: Matul il-laqgħa tiegħu tat-13-15 ta' Ottubru 2009, il-Kumitat ftihem dwar talba mingħand detentur talawtorizzazzjoni għat-tqegħid fis-suq wieħed sabiex jipprovdi spjegazzjoni orali lis-CVMP li kienet sussegwentament irtirata mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: The water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water, are used for treatment of respiratory and gastrointestinal infections caused by different bacterial pathogens susceptible to doxycycline.
Maltese: It-trab li jinħall fl-ilma u s-soluzzjonijiet orali li fihom doxycycline hyclate indikati għall-użu fit-tjur u maħsubin biex jingħataw permezz tal-ilma tax-xorb, jintużaw għall-kura ta' infezzjonijiet respiratorji u gastrointestinali ikkawżati minn patoġeni batteriċi differenti suxxettibbli għal doxycycline.
English: Due to concerns that the differences in the posology, dose range, duration of treatment and withdrawal periods established across the European Union for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water may present a potential serious risk to public and animal health, the United Kingdom referred the matter to the Agency on 11 February 2009, under Article 35 of Directive 2001/82/EC.
Maltese: Minħabba tħassib dwar id-differenzi fil-pożoloġija, il-firxa tad-doża, it-tul tal-kura u l-perjodi ta' tiżmim stabbiliti madwar l-Unjoni Ewropea għall-qawwiet kollha tat-trab li jinħall fl-ilma u solzzjonijiet orali li fihom doxycycline hyclate indikati għall-użu fit-tjur u maħsubin biex jingħataw permezz tal-ilma taxxorb jistgħu jippreżentaw riskju serju għas-saħħa pubblika u għas-saħħa tal-annimali, ir-Renju Unit irrefera l-kwistjoni lill-Aġenzija fil-11 ta' Frar 2009 skont l-Artikolu 35 tad-Direttiva 2001/82/KE.
English: The referral procedure started on 11 February 2009.
Maltese: Il-proċedura ta' referenza bdiet fil-11 ta' Frar 2009.
English: referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water
Maltese: għallqawwiet kollha tat-trab li jinħall fl-ilma u soluzzjonijiet orali li fihom doxycycline hyclate indikat għall-użu fit-tjur u maħsub biex jingħata permezz tal-ilma tax-xorb
English: The final opinion was converted into a Decision by the European Commission on 14 June 2010.
Maltese: L-opinjoni finali inqelbet għal Deċiżjoni mill-Kummissjoni Ewropea fl-14 ta' Ġunju 2010.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP did not identify emerging risks to human or animal health arising as a result of differences in the posology, dose range, duration of treatment and withdrawal periods established across the European Union and did not therefore recommend changes to these aspects of the summary of the product characteristics (SPC), labelling and package leaflet.
Maltese: Fuq il-bażi tal-istima tar-rapporteurs tad-data disponibbli dak iż-żmien, is-CVMP ma identifikax riskji emerġenti għas-saħħa tal-bniedem jew tal-annimali b'konsegwenza tad-differenza fil-pożoloġija, il-firxa tad-doża, it-tul tal-kura u l-perjodi ta' tiżmim stabbiliti madwar l-Unjoni Ewropea u għalhekk ma rrakkomandax tibdiliet f'dawn l-aspetti tas-sommarju tal-karatteristiċi tal-prodott (SPC), tikketta u fuljett ta' tagħrif.
English: Ref. EMEA/651597/2008
Maltese: EMEA/651597/2008
English: London, 19 December 2008 Doc.
Maltese: Londra, 19 ta' Diċembru 2008 Dok ta' Ref.
English: International non-proprietary name (INN): nimotuzumab
Maltese: Denominazzjoni Internazzjonali Komuni (INN): nimotuzumab
English: What is Theraloc?
Maltese: X'inhu Theraloc?
English: Theraloc was designated as an orphan medicinal product on 2 September 2004.
Maltese: Theraloc ġie innominat bħala prodott mediċinali orfni fit-2 ta' Settembru 2004.
English: The active substance in Theraloc, nimotuzumab, is a monoclonal antibody.
Maltese: Is-sostanza attiva f'Theraloc, nimotuzumab, hija antikorp monoklonali.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Maltese: Normalment is-CHMP idum sa jum 210 biex jevalwa applikazzjoni ġdida.
English: It contains the active substance nimotuzumab.
Maltese: Fih is-sustanza attiva nimotuzumab.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: Ladarba l-kumpanija tkun ipprovdiet it-tweġibiet tagħha għall-mistoqsijiet imressqa, isCHMP jirrevedihom u jista', qabel ma jagħti opinjoni, jistaqsi mistoqsijiet oħra fil-jum 180.
English: Nimotuzumab binds to an antigen called epidermal growth factor receptor (EGFR), a protein that can be found on the surface of certain tumour cells.
Maltese: Nimotuzumab jingħaqad ma' antiġen imsejjaħ riċettur tal-fattur tattkabbir epidermali (epidermal growth factor receptor - EGFR), proteina li tista' tinstab fuq il-wiċċ ta' ċerti ċelloli ta' tumuri.
English: On 1 December 2008, Oncoscience AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Theraloc, for the treatment of children and adolescents with resistant or recurrent high-grade glioma.
Maltese: Fl-1 ta' Diċembru 2008, Oncoscience AG innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Theraloc, għall-kura tat-tfal u adolexxenti li għandhom glijoma ta' grad għoli reżistenti jew rikorrenti.
English: No information was provided on whether the body would produce antibodies against the medicine and there was a high rate of serious side effects.
Maltese: Ma ġiet ipprovduta ebda informazzjoni dwar jekk il-ġisem jipproduċix antikorpi kontra l-mediċina u kien hemm rata għolja ta' effetti sekondarji serji.
English: Theraloc has been studied in one main study involving 47 children and adolescents with glioma who had no treatments available that could cure their disease.
Maltese: Theraloc ġie studjat fi studju ewlieni wieħed li kien jinvolvi 47 tifel u tifla u adolexxenti bi glijoma li ma kellhomx kuri disponibbli għalihom li setgħu jfejqu l-marda tagħhom.
English: How is Theraloc expected to work?
Maltese: Kif inhuwa mistenni li jaħdem Theraloc?
English: By blocking EGFR, nimotuzumab was expected to slow down the progression of glioma.
Maltese: Billi jimblokka l-EGFR, nimotuzumab kien mistenni li jittardja l-iżvilupp tal-glijoma.
English: Theraloc is a concentrate that is made up into a solution for infusion (drip into a vein).
Maltese: Theraloc huwa konċentrat li jiġi magħmul f'soluzzjoni għall-infużjoni (dripp ġol-vina).
English: The effects of Theraloc were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Theraloc l-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Questions and answers on the withdrawal of the marketing application for Theraloc
Maltese: Mistoqsijiet u tweġibiet dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Theraloc
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Fuq il-bażi tar-reviżjoni tad-dokumentazzjoni inizjali, is-CHMP iħejji lista ta' mistoqsijiet fil-jum 120, li tintbagħat lillkumpanija.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Theraloc could not have been approved for the treatment of children and adolescents with recurrent high-grade glioma.
Maltese: Fuq il-bażi tal-reviżjoni tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tasCHMP fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Theraloc ma setax jiġi approvat għall-kura ta' tfal u adolexxenti bi glijoma rikorrenti ta' grad għoli.
English: Theraloc was to be used when the glioma was ‘resistant' (it did not respond to other treatments) or ‘recurrent' (it had come back after previous treatment).
Maltese: Theraloc kellu jintuża meta l-glijoma tkun ‘reżistenti' (ma wrietx reazzjoni għal kuri oħra) jew ‘rikorrenti' (reġgħet feġġet wara kura preċedenti).
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li tfassal biex jagħraf u jingħaqad ma' struttura speċifika (li tissejjaħ antiġen) li tinsab fuq ċerti ċelloli fil-ġisem.
English: The application was at day 173 when the company withdrew.
Maltese: L-applikazzjoni kienet waslet f'jum 173 meta l-kumpanija rtiratha.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Maltese: Wara li s-CHMP kien ivvaluta ttweġibiet tal-kumpanija għal lista ta' mistoqsijiet, kien għad hemm xi kwistjonijiet mhux solvuti.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Theraloc.
Maltese: Il-kumpanija għarrfet lis-CHMP li ma kienx hemm konsegwenzi għall-pazjenti li jkunu inklużi fi provi kliniċi jew fi programmi ta' użu b'kumpassjoni bi Theraloc.
English: Theraloc was expected to be used to treat adolescents and children from the age of three years with high-grade glioma.
Maltese: Theraloc kien mistenni li jintuża għall-kura ta' adolexxenti u tfal mill-età ta' tliet snin bi glijoma ta' grad għoli.
English: Uferstrasse 15
Maltese: Uferstraße 15
English: Tel: +44(0)1256 894 959 e-mail: medinfoEMEA@shire.com
Maltese: Tel: +44(0)1256 894 959 e-mail: http://www.ema.europa.eu/
English: Mean (95% CI) SD
Maltese: Medja (95% CI) SD
English: ATC code: B02BD10
Maltese: B02BD10
English: 50 to 80 IU/kg
Maltese: 50 sa 80 IU/kg
English: MedDRA System Organ Class (SOC)
Maltese: Sistema tal-Klassifika tal-Organi fid-database MedDRA (SOC, System Organ Class)
English: Note:
Maltese: NOTA:
English: (N=80) n (%)
Maltese: (N=80)
English: Manufacturer Baxter AG Industriestraße 67 A-1221 Vienna Austria
Maltese: Manifattur Baxter AG Industriestraße 67 A-1221 Vienna L-Awstrija
English: Neutralizing antibodies (Inhibitors)
Maltese: Antikorpi newtralizzanti (Inibituri)
English: Clb IR at Cmax c
Maltese: IR fis-Cmax c
English: Type of Surgery
Maltese: Tip ta' Operazzjoni
English: Adverse Reaction by Preferred Term (PT)
Maltese: Reazzjoni Avversa bit-Terminu Preferut (PT, Preferred Term)
English: Do not store above 30°C.
Maltese: Aħżen f'temperatura taħt 30°C.
English: Generally, 1 IU/kg (VWF:RCo/VEYVONDI/vonicog alfa) raises the plasma VWF:RCo by 0.02 IU/mL (2%).
Maltese: Ġeneralment, 1 IU/kg ta' (VWF:RCo/VEYVONDI/vonicog alfa) iżid il-VWF:RCo fil-plażma b'0.02 IU/mL (2%).
English: See section 2 “VEYVONDI contains sodium”.
Maltese: Ara sezzjoni 2 “VEYVONDI fih is-sodium”.
English: Table 5 Pharmacokinetic Assessment of VWF:RCo f
Maltese: Evalwazzjoni Farmakokinetika ta' VWF:RCo f
English: INFORMATION IN BRAILLE VEYVONDI 1300 IU
Maltese: INFORMAZZJONI BIL-BRAILLE VEYVONDI 1300
English: Minimum Duration of treatment
Maltese: Tul Minimu ta' trattament
English: INFORMATION IN BRAILLE VEYVONDI 650 IU
Maltese: INFORMAZZJONI BIL-BRAILLE VEYVONDI 650
English: A total of 92 unique subjects (80 unique subjects with VWD in studies 070701, 071001 and 071101 and 12 subjects with Haemophilia A in study 071104) were exposed to VEYVONDI during clinical development.
Maltese: Total ta' 92 individwu uniku (80 individwu uniku b'VWD fi studji 070701, 071001 u 071101 u 12-il individwu b'Emofilija A fi studju 071104) ġew esposti għal VEYVONDI matul l-iżvilupp kliniku.
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti skont il-konvenzjonijiet li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Surgery PK50 VEYVONDI (Study 071101)
Maltese: Operazzjoni PK50 VEYVONDI (Studju 071101)
English: The clinical safety, efficacy and PK data were assessed in 3 completed trials, (070701, 071001 and 071101) which enrolled patients with VWD.
Maltese: Id-dejta klinika tas-sigurtà, tal-effikaċja u tal-PK ġiet evalwata fi 3 provi li tlestew (070701, 071001 u 071101) li rreġistraw pazjenti b'VWD.
English: Subsequent infusions:
Maltese: Infużjonijiet sussegwenti:
English: Specific activity: approx. 110 IU VWF:RCo/mg protein
Maltese: Attività speċifika: madwar 110 IU VWF:RCo/mg ta' proteina
English: Unopened vial 3 years.
Maltese: Kunjett mhux miftuħ 3 snin.
English: Table 4 Summary of Adverse Reactions reported in Clinical Trials with VEYVONDI in von Willebrand Disease
Maltese: Tabella 4 Sommarju tar-Reazzjonijiet Avversi rrappurtati fil-Provi Kliniċi b'VEYVONDI fil-Marda ta' von Willebrand
English: The mean duration of infusion was 16.5 minutes (SD ± 3.51 minutes) for 50 IU/kg (PK50) and 11.8 minutes (± 2.86 minutes) for 80 IU/kg VWF:RCo (PK80).
Maltese: IU/kg (PK50) u 11.8 minuti (± 2.86 minuti) għal infużjoni ta' 80 IU/kg VWF:RCo (PK80).
English: (IU VWF:RCo/kg body weight)
Maltese: (IU VWF:RCo/kg ta' piż tal-ġisem)
English: Sodium citrate, glycine, trehalose dihydrate, mannitol, polysorbate 80 and water for injections.
Maltese: Sodium citrate, glycine, trehalose dihydrate, mannitol, polysorbate 80, u ilma għall-injezzjonijiet.
English: The recommended minimum target levels are 0.4 IU/mL for minor and oral surgery and 0.8 IU/mL for major surgery.
Maltese: Il-livelli fil-mira minimi rakkomandati huma 0.4 IU/mL għal operazzjoni minuri u orali, u 0.8 IU/mL għal operazzjoni maġġuri.
English: You can have an allergic reaction to VEYVONDI.
Maltese: Jista' jkollok reazzjoni allerġika għal VEYVONDI.
English: VEYVONDI contains trace amounts of mouse immunoglobulin G (MuIgG) and Hamster proteins (less than or equal to 2 ng/IU VEYVONDI).
Maltese: VEYVONDI fih traċċi ta' immunoglobulina G tal-ġrieden (MuIgG) u proteini tal-ħamster (inqas minn jew ugwali għal 2 ng/IU ta' VEYVONDI).
English: Minor ≥ 0.30 IU/mL
Maltese: ≥ 0.30 IU/mL
English: An exploratory analysis of combined data from studies 070701 and 071001 indicated a statistically significantly (at the 5% level) longer mean residence time, a statistically significantly (at the 5% level) longer terminal half-life and statistically significantly (at the 5% level) larger AUC0-inf regarding VWF:RCo following administration with VEYVONDI (50 IU/kg VWF:RCo) and combined administration of VEYVONDI and octocog alfa (50 IU/kg VWF:RCo and 38.5 IU/kg rFVIII) than after administration of pdVWF and pdFVIII (50 IU/kg pdVWF:RCo and 38.5 IU/kg pdFVIII).
Maltese: Analiżi esploratorja ta' data kkombinata minn studji 070701 u 071001 indikat ħin statistikament sinifikanti (fil-livell ta' 5%) ta' residenza medju itwal, half-life terminali itwal statistikament sinifikanti (fil-livell ta' 5%) u AUC0-inf itwal statistikament sinifikanti (fil-livell ta' 5%) rigward VWF:RCo wara l-għoti ta' VEYVONDI (50
English: A combination with a FVIII product containing VWF would pose an additional risk of thrombotic events.
Maltese: Kombinazzjoni bi prodott b'FVIII li fih VWF tista' tippreżenta riskju addizzjonali ta' episodji trombotiċi.
English: The most common post-marketing ADRs reported in association with rVWF/vonicog alfa treatment include “infusion-related reaction” (IRR) clinically manifested by the following symptoms: tachycardia, flushing, rash, dyspnea, and blurred vision.
Maltese: L-ADRs wara t-tqegħid fis-suq l-aktar komuni rrappurtati f'assoċjazzjoni mat-trattament b'rVWF/vonicog alfa jinkludu “reazzjoni relatata mal-infużjoni” (IRR, infusion-related reaction) manifestata klinikament bis-sintomi li ġejjin: takikardija, fwawar, raxx, dispnea, u viżjoni mċajpra.
English: (e.g. severe or refractory epistaxis, menorrhagia, gastrointestinal bleeding, central nervous system trauma, haemarthrosis, or traumatic haemorrhage)
Maltese: (eż. epistassi severa jew refrattarja, menorraġija, ħruġ ta' demm gastro-intestinali, trawma fis-sistema nervuża ċentrali, emartrożi, jew emorraġija trawmatika)
English: Calculating dose VEYVONDI dose [IU] = dose [IU/kg] x weight [kg]
Maltese: Doża ta' VEYVONDI [IU] = doża [IU/kg] x piż [kg]
English: The pharmacokinetics (PK) of VEYVONDI were determined in three clinical studies by assessing the plasma levels of VWF:RCo, von Willebrand Factor Antigen (VWF:Ag), and von Willebrand Collagen Binding Activity (VWF:CB).
Maltese: Il-farmakokinetika (PK) ta' VEYVONDI ġiet determinata fi tliet studji kliniċi billi ġew evalwati l-livelli fil-plażma ta' VWF:RCo, tal-Fattur Antiġenu von Willebrand (VWF:Ag), u tal-Attività li Tgħaqqad il-Kollagen ta' von Willebrand (VWF:CB).
English: Marketing Authorisation Holder Baxalta Innovations GmbH Industriestraße 67
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Baxalta Innovations GmbH Industriestraße 67
English: Phase 3 PK50 VEYVONDI (Study 071001)
Maltese: Fażi 3 PK50 VEYVO NDI (Studju 071001)
English: VEYVONDI contains trace amounts of recombinant coagulation factor VIII.
Maltese: VEYVONDI fih traċċi ta' fattur VIII koagulatorju rikombinanti.
English: Table 6 summarizes the PK of VEYVONDI after 50 IU/kg VWR:RCo (PK50) or 80 IU/kg VWF:RCo (PK80) infusions .
Maltese: IU/kg VWF:RCo (PK50) jew 80 IU/kg VWF:RCo (PK80).
English: Phase 1 PK50 VEYVONDI with octocog alfag
Maltese: Parametru Fażi 1 PK50 VEYVO NDI ma' octocog alfa g
English: Baxalta Manufacturing Sarl Route de Pierre-a-Bot 111 CH-2000 Neuchatel SWITZERLAND
Maltese: Route de Pierre-a-Bot 111
English: Do not infuse any faster than 4 mL per minute.
Maltese: Tagħtix l-infużjoni b'rata mgħaġġla ta' aktar minn 4 mL kull minuta.
English: Δ = Target peak plasma VWF:RCo - baseline plasma VWF:RCo cIR = Incremental Recovery as measured in the subject.
Maltese: Δ = Livell massimu fil-mira ta' VWF:RCo fil-plażma - livell fil-linja bażi ta' VWF:RCo fil-plażma c IR (Incremental Recovery) = Irupru Inkrementali kif imkejjel fl-individwu.
English: The immunogenicity of VEYVONDI was assessed in clinical trials by monitoring the development of neutralizing antibodies against VWF and FVIII, as well as binding antibodies against VWF, Furin, Chinese Hamster Ovary (CHO) protein and mouse IgG.
Maltese: L-immunoġeniċità ta' VEYVONDI ġiet evalwata fil-provi kliniċi permezz tal-monitoraġġ tal-iżvilupp ta' antikorpi newtralizzanti kontra VWF u FVIII, kif ukoll antikorpi li jeħlu kontra VWF, Furin, proteini tal-Ovarju tal-Ħamster Ċiniż (CHO, Chinese Hamster Ovary) u IgG tal-ġrieden.
English: VEYVONDI 1300 IU powder and solvent for solution for injection Each vial of powder contains nominally 1300 International Units (IU) vonicog alfa.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett ta' trab nominalment fih 1300 Unità Internazzjonali (IU, International Units) ta' vonicog alfa.
English: Electrocardiogram T wave inversion
Maltese: Inverżjoni tat-T wave fuq l-elettrokardjogramma
English: - Do not mix vonicog alfa with other medicinal products except for rFVIII.
Maltese: - Tħallatx vonicog alfa ma' prodotti mediċinali oħra, ħlief rFVIII.
English: Up to 72 hours post surgery
Maltese: Sa 72 siegħa wara l-operazzjoni
English: - Do not refrigerate the solution after preparation.
Maltese: - Tpoġġix is-soluzzjoni fi friġġ wara l-preparazzjoni.
English: There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors for thrombosis including low ADAMTS13 levels.
Maltese: Hemm riskju ta' okkorrenza ta' avvenimenti trombotiċi, partikularment f'pazjenti b'fatturi ta' riskju kliniku jew tal-laboratorju magħrufa għal trombożi, li jinkludu livelli baxxi ta' ADAMTS13.
English: The product contains only trace amounts of human recombinant coagulation factor VIII (≤ 0.01 IU FVIII / IU VWF: RCo) as determined using the European Pharmacopoeia chromogenic assay for factor VIII (FVIII).
Maltese: Il-prodott fih biss traċċi ta' fattur VIII tal-koagulazzjoni rikombinanti umana (≤ 0.01 IU FVIII / IU VWF: RCo) kif determinat bl-użu tal-assaġġ kromoġeniku tal-Farmakopea Ewropea għal fattur VIII (FVIII).
English: The specific activity of VEYVONDI is approximately 110 IU VWF:RCo/mg protein.
Maltese: L-attività speċifika ta' VEYVONDI hija ta' madwar 110 IU VWF:RCo/mg ta' proteina.
English: Be careful not to touch the clear plastic spike.
Maltese: Oqgħod attent biex ma tmissx il-ponta trasparenti tal-plastik.
English: During treatment with VEYVONDI the following adverse reactions may occur: Hypersensitivity or allergic reactions, thromboembolic events, inhibitor formation against VWF.
Maltese: Waqt it-trattament b'VEYVONDI jistgħu jseħħu r-reazzjonijiet avversi li ġejjin: Sensittività eċċessiva jew reazzjonijiet allerġiċi, avvenimenti tromboemboliċi, formazzjoni ta' inibituri kontra l-VWF.
English: Minor (e.g. epistaxis, oral bleeding, menorrhagia)
Maltese: Minuri (eż. epistassi, ħruġ ta' demm orali, menorraġija)
English: Replacement levels of VWF:RCo > 0.6 IU/mL (60%) and FVIII:C > 0.4 IU/mL (40%) should be achieved.
Maltese: IU/mL (60%) u FVIII:C > 0.4
English: VEYVONDI is usually infused into a vein (intravenously) by your doctor or nurse.
Maltese: VEYVONDI normalment jiġi infuż ġo vina (b'mod intravenuż) mit-tabib jew mill-infermier tiegħek.
English: (Study 070701)
Maltese: (Studju 070701) Medja (95% CI) SD
English: FVIII:C Target Peak Plasma
Maltese: Livell Massimu ta' Plażma fil-Mira FVIII:C
English: 40 to 50 IU/kg
Maltese: 40 sa 50
English: This is equivalent to 2.2% of the recommended maximum daily dietary intake of sodium for an adult, assuming 70 kg body weight and 80 IU/kg body weight.
Maltese: Dan huwa ekwivalenti għal 2.2% tad-doża massima ta' kuljum rakkomandata ta' sodium għal adult, jekk wieħed jassumi piż tal-ġisem ta' 70 kg u doża ta' 80 IU/kg piż tal-ġisem.
English: 72 hours Every 12-24 hrs / every other day
Maltese: IU/mL 72 siegħa Kull 12-24 siegħa/ kull jumejn
English: e[(h*IU/dL)/(IU VWF:RCo/kg)] f[VWF:RCo assays with different sensitivity and working ranges were used: Phase 1: automated assay 0.081.50 IU/mL and sensitive manual assay 0.01 - 0.08 IU/mL; Phase 3: automated assay 0.08 - 1.50 IU/mL g This trial was done using ADVATE, a recombinant factor VIII
Maltese: IU/mL u assaġġ manwali sensittiv 0.01 - 0.08 IU/mL; Fażi 3: assaġġ awtomizzat 0.08 - 1.50
English: In patients requiring frequent doses of VEYVONDI in combination with recombinant factor VIII, plasma levels for FVIII:C activity should be monitored to avoid sustained excessive FVIII:C plasma levels, which may increase the risk of thrombotic events.
Maltese: F'pazjenti li jeħtieġu dożi frekwenti ta' VEYVONDI flimkien ma' fattur VIII rikombinanti, il-livelli fil-plażma għal attività ta' FVIII:C għandhom jiġu mmonitorjati sabiex jiġu evitati livelli sostnuti eċċessivi ta' FVIII fil-plażma, li jistgħu jżidu r-riskju ta' avvenimenti trombotiċi.
English: VEYVONDI contains sodium
Maltese: VEYVONDI fih is-sodium
English: The ristocetin cofactor activity of recombinant human von Willebrand factor was determined against the International Standard for von Willebrand factor concentrate (WHO).
Maltese: L-attività tal-kofattur ristocetin tal-fattur von Willebrand uman rikombinanti ġiet iddeterminata kontra l-Istandard Internazzjonali għall-konċentrat tal-fattur von Willebrand (WHO).