FrancophonIA/ELRC3.0 huggingface dataset:
English: These studies were: cross-over, openlabel, randomised treatment sequence bioequivalence studies carried out in healthy volunteers; they took into account the current guidelines and the pharmacological characteristics of pantoprazole, the prolonged T-max, the increased variability (especially Cmax), and the unaltered half-life under fed conditions.
Maltese: Dawn l-istudji kienu: studji cross-over, studji bit-tiketta mikxufa, studji ta' bijoekwivalenza ta' sekwenza ta' trattament randomizzati mwettqa f'voluntiera b'saħħithom; qiesu l-linji gwida attwali u l-karatteristiċi farmakoloġiċi ta' pantoprazole, it-T-max imtawwal, il-varjabbiltà miżjuda (b'mod speċjali Cmax), u l-half-life mhux mibdul taħt kundizzjonijiet wara ikla.
English: A period of 15 hours was consequently deemed to be suitable for quantification of at least 80 % of the total AUC, as recommended in the guidelines.
Maltese: Konsegwentament, perjodu ta' 15-il siegħa tqies li jkun xieraq għall-kwantifikazzjoni ta' millinqas 80% tal-AUC totali, kif rakkomandat fil-linji gwida.
English: The Applicant committed to update the Summary of Product Characteristics and Package Leaflet in accordance to the outcome of the ongoing SPC harmonisation procedure under Article 30 of Directive 2001/83/EC with the reference product Protium and associated names.
Maltese: L-Applikant impennja ruħu li jaġġorna s-Sommarju tal-Karatteristiċi tal-Prodott u l-Fuljett ta' Tagħrif skont ir-riżultat tal-proċedura ta' armonizzazzjoni tal-SPC li ma tieqafx skont l-Artikolu 30 tadDirettiva 2001/83/KE bil-prodott ta' referenza Protium u ismijiet assoċjati.
English: • The rate of outlying cases from the test formulation must be no greater than the reference + 20 %
Maltese: • Ir-rata tal-każijiet li ma jikkonformawx mal-formolazzjoni tat-test ma għandhiex tkun ikbar mir referenza + 20 % (imqarrba għall-eqreb valur sħiħ).
English: This kinetic alteration appears frequently with pantoprazole and is the basis as to why the Summary of Product Characteristics for Pantoprazole products in the EU state: ‘Swallow whole with water before a meal'.
Maltese: Dan it-tibdil kinetiku jidher frekwenti ma' pantoprazole u huwa l-bażi l-għala s-Sommarju tal-Karatteristiċi tal-Prodott għal prodotti ta' Pantoprazole fl-UE jiddikjara: ‘Ibla' sħiħ mal-ilma qabel ikla'.
English: The CHMP concluded that both formulations are equivalent and are therapeutically equivalent and that there is no risk to the clinical management of the patients.
Maltese: IsCHMP ikkonkluda li ż-żewġ formolazzjonijiet huma ekwivalenti u huma terapewtikament ekwivalenti u li ma hemm ebda riskju għall-ġestjoni klinika tal-pazjenti.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Maltese: TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, APPLIKANTI FL-ISTATI
English: The European Guidelines lay down the criteria for the design of bioavailability and bioequivalence studies (CPMP/EWP/QWP/1401/98).
Maltese: Il-Linji Gwida Ewropej jistabbilixxu l-kriterji għad-disinn tal-istudji tal-bijodisponibbiltà u talbijoekwivalenza (CPMP/EWP/QWP/1401/98).
English: It was demonstrated that the effect of such delays on the absorption of pantoprazole in terms of the drug efficacy, in individual patients is relevant for AUC, but not for the Cmax as AUC correlates with the degree of acid suppression [Hatlebakk, 1996; Thompson, 1997].
Maltese: Intwera li l-effett ta' dewmien bħal dan fuq l-assorbiment ta' pantoprazole f'termini tal-effikaċja talmediċina, f'pazjenti individwali huwa relevanti għall-AUC, iżda mhux għas-Cmax minħabba li l-AUC jikkorrelata mal-ammont ta' soppressjoni tal-aċidu [Hatlebakk, 1996;
English: The CHMP noted that the expansion of the stated confidence interval for Cmax was not prospectively defined in the study protocol.
Maltese: Is-CHMP innota li l-espansjoni tal-intervall ta' fiduċja ddikjarat għal Cmax ma ġiex definit prospettivament fil-protokoll tal-istudju.
English: The Applicant pointed out that in defined situations, as for pantoprazole, wider interval (75-133 %) for Cmax may be acceptable “if justified, addressing in particular any safety or efficacy concerns for patients switched between formulations”.
Maltese: L-Applikant indika li f'sitwazzjonijiet definiti, bħal fil-każ ta' pantoprazole, intervall usa' (75-133%) għal Cmax jista' jkun aċċettabbli “jekk iġġustifikat, li jindirizza b'mod partikolari kwalunkwe tħassib tassigurtà u l-effikaċja għal pazjenti li jinqelbu bejn formolazzjoni u oħra”.
English: The parameters determined, methods used for analysis, and success criteria appear to be standard and are considered acceptable; however the CHMP asked the Applicant to clarify the failed demonstration of bioequivalence regarding the parameter Cmax in the study report.
Maltese: Il-parametri, metodi użati għall-analiżi, u l-kriterji ta' suċċess stabbiliti jidhru li huma standard u huma meqjusin aċċettabbli; madankollu, is-CHMP talab lill-Applikant sabiex jiċċara nnuqqas ta' turija ta' bijoekwivalenza fir-rigward tal-parametru Cmax fir-rapport tal-istudju.
English: The findings from the food interaction study together with the demonstration of bioequivalence in the fasting state (the recommended method of dosing), and with the extensive in vitro dissolution data (designed to mimic the gastric “milieu” after food) were considered to adequately exclude a formulation difference in terms of the integrity of the enteric coating and the risk of dose dumping.
Maltese: It-tisjib mill-istudji ta' interazzjoni tal-ikel flimkien mat-turija tal-bijoekwivalenza fl-istat ta' sawm (il-metodu rrakkomandat tad-dożaġġ), u bid-dejta estensiva tad-dissoluzzjoni in vitro (imfassla sabiex timmimitizza l-“ambjent” gastriku wara l-ikel) tqiesu li jeskludu adegwatament differenza fil-formolazzjoni f'termini tal-integrità tal-kisja enterika u r-riskju ta' dumping tad-doża.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PANTOPRAZOLE OLINKA AND ASSOCIATED NAMES (SEE ANNEX I)
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' PANTOPRAZOLE OLINKA U ISMIJIET ASSOĊJATI (ARA L-ANNESS I)
English: In individual patients it was demonstrated that AUC, but not Cmax, correlates with the degree of acid suppression, which is known to correlate with the cure of acid-related diseases, and that there is no temporal association between the peak plasma concentration and the maximum acid suppression caused by the proton pump inhibitors [Hatlebakk, 1996].
Maltese: F'pazjenti individwali ntwera li AUC, iżda mhux Cmax, jikkorrelata mal-grad ta' soppressjoni tal-aċidi, li huwa magħruf li jikkorrelata malkura ta' mard relatat mal-aċidi, u li ma hemm ebda assoċjazzjoni temporanja bejn l-ogħla konċentrazzjoni tal-plasma u s-soppressjoni massima tal-aċidi kkawżata mill-inibituri tal-pompa tal-proton [Hatlebakk,
English: In the food-interaction study, the protocol set-out criteria for outliers based on pilot data that defined possible exclusions based on the following:
Maltese: Fl-istudju ta' interazzjoni tal-ikel, il-protokoll stabbixxa kriterji għal dawk li ma jikkonformawx ibbażati fuq id-dejta pilota li ddefiniet esklużjonijiet possibbli fuq il-bażi ta' dawn li ġejjin:
English: The following Potential Serious Risk to Public Health (PSRPH) concern was therefore referred to the CHMP: the Study PAN 2006/006 (fed bioequivalence) did not adequately evaluate the properties of the test formulation in relation to the intake of a meal and the possibility of a formulation difference between the test and the reference product has therefore not been sufficiently excluded.
Maltese: It-tħassib għar-Riskju Serju Potenzjali għas-Saħħa Pubblika (PSRPH) li ġej ġie għaldaqstant riferut lis-CHMP: l-Istudju PAN 2006/06 (bijoekwivalenza wara ikla) ma evalwax ilkaratteristiċi tal-formolazzjoni tat-test adegwatament fir-rigward tat-teħid ta' ikla u għaldaqstant, ilpossibbiltà ta' differenza fil-formolazzjoni bejn il-prodott tat-test u l-prodott ta' referenza ma ġietx eskluża b'mod suffiċjenti.
English: Parameters (units)
Maltese: Parametri (unitajiet)
English: MedDRA Standard System Organ Class
Maltese: Standard MedDRA Sistema tal-Klassifika tal-Organi
English: The primary efficacy variable was annualized bleed rate (ABR).
Maltese: (ABR - annualized bleed rate).
English: Adolescent population
Maltese: Popolazzjoni adolexxenti
English: Repeat injection every 24-48 hours.
Maltese: Irrepeti l-injezzjoni kull 24-48 siegħa.
English: Date of first authorisation: 22 November 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' Novembru 2018
English: Immune response to polyethylene glycol (PEG)
Maltese: Rispons immuni għal polyethylene glycol (PEG)
English: Total (≥ 12 years) N=145
Maltese: Total (≥ 12-il sena) N=145
English: Acetic acid, glacial (for pH adjustment)
Maltese: Acetic acid, glacial (għal aġġustament tal-pH)
English: There is limited experience in patients ≥ 65 years.
Maltese: Hemm esperjenza limitata f'pazjenti ta' ≥ 65 sena.
English: The maximum rate is 2.5 mL per minute.
Maltese: Ir-rata massima hija ta' 2.5 mL kull minuta.
English: AUC (IU*h/dL) AUC, norm (h*kg/dL) Cmax (IU/dL) t½ (h)
Maltese: AUC (IU*siegħa/dL) AUC, norm (siegħa*kg/dL) Cmax (IU/dL) t½ (siegħa)
English: ≥ 18 years N=133
Maltese: ≥ 18-il sena N=133
English: Jivi contains sodium
Maltese: Jivi fih sodium
English: • local infections
Maltese: • infezzjonijiet lokali
English: Damoctocog alfa pegol is a PEGylated form of rFVIII.
Maltese: Damoctocog alfa pegol huwa forma PEGilat ta' rFVIII.
English: MRTIV (h) Vss (dL/kg) CL (dL/h/kg)
Maltese: Vss (dL/kg) CL (dL/siegħa/kg)
English: INFORMATION IN BRAILLE Jivi 3000
Maltese: INFORMAZZJONI BIL-BRAILLE Jivi 3000
English: • one vial adapter (with integrated filter)
Maltese: • adapter tal-kunjett wieħed (b'filtru integrat)
English: The molecular weight of the protein is approximately 234 kDa.
Maltese: Il-piż molekulari tal-proteina huwa ta' madwar 234 kDa.
English: Jivi Patients ≥12 years n=22
Maltese: Jivi Pazjenti ta' ≥12-il sena N=22
English: A total of 20 major surgical procedures were performed and assessed in 17 patients.
Maltese: Total ta' 20 proċedura kirurġika maġġuri ġew imwettqa u evalwati fi 17-il pazjent.
English: Additional 34 minor surgeries were performed in 19 patients.
Maltese: Twettqu 34 kirurġija minuri oħra f'19-il pazjent.
English: Anti¬PEG antibodies
Maltese: Antikorpi anti-PEG
English: Table 2: Frequency of adverse drug reactions in clinical trials
Maltese: Tabella 2: Frekwenza ta' reazzjonijiet avversi għal mediċina fil-provi kliniċi
English: The median (range) dose per injection was 31.7 IU/kg (14; 62).
Maltese: Id-doża medjana (firxa) għal kull injezzjoni kienet ta' 31.7 IU/kg (14; 62).
English: In distribution and excretion studies in rats, the 60 kDa PEG moiety of Jivi was shown to be widely distributed to and eliminated from organs and tissues, and excreted in urine (68.4% up to day 231 after administration) and faeces (13.8% up to day 168 after administration).
Maltese: Fi studji dwar id-distribuzzjoni u t-tneħħija fil-firien, il-parti ta' 60 kDa PEG ta' Jivi intwera li kellha distribuzzjoni mifruxa għal u eliminazzjoni minn organi u tessuti, u tneħħija fl-awrina (68.4% sa jum 231 wara l-għoti) u l-ippurgar (13.8% sa jum 168 wara l-għoti).
English: The median (Q1; Q3) recovery was 2.6 (2.3; 3.0) by chromogenic assay.
Maltese: L-irkupru medjan (Q1; Q3) kien ta' 2.6 (2.3; 3.0) permezz ta' analiżi kromoġenika.
English: 12-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain factor VIII activity of 30-60% (IU/dL).
Maltese: Irrepeti d-doża kull 12-24 siegħa sakemm ikun hemm fejqan adegwat tal-ferita, u wara terapija għal mill-anqas 7 ijiem oħra biex tinżamm attività tal-fattur VIII ta' 30-60% (IU/dL).
English: CA
Maltese: JIS
English: The overall median (Q1; Q3) total ABR was 1.17 (0.0; 4.3) and 0.6 (0.0: 3.2) for spontaneous bleeds in the combined prophylaxis groups and total ABR was 33.0 in the on-demand group.
Maltese: B'mod globali l-ABR totali medjana (Q1; Q3) kienet ta' 1.17 (0.0; 4.3) u 0.6 (0.0: 3.2) għal fsad spontanju fil-gruppi ta' profilassi kkombinati u l-ABR totali kienet ta' 33.0 fil-grupp ta' trattament fil-pront.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: It-tabella ppreżentata hawn taħt hi skont is-sistema tal-klassifikazzjoni tal-organi MedDRA (SOC - system organ classification u l-Livell tat-Terminu Preferut).
English: • a vial adapter
Maltese: • adapter tal-kunjett
English: For prophylaxis the dose is 45-60 IU/kg every 5 days.
Maltese: Għall-profilassi d-doża hija ta' 45-60 IU/kg kull 5 ijiem.
English: The active substance, damoctocog alfa pegol, is a site specifically PEGylated B-domain deleted recombinant human coagulation factor VIII, produced in baby hamster kidney cells (BHK), with a 60 kDa branched polyethylene-glycol (two 30 kDa PEG) moiety.
Maltese: Is-sustanza attiva, damoctocog alfa pegol, hija fattur VIII tal-koagulazzjoni rikombinanti uman, speċifiku għas-sit, PEGilat, b'dominju B imħassar, magħmul f'ċelluli tal-kliewi ta' frieħ tal-ħamsters (BHK - baby hamster kidney cells), b'60 kDa branched polyethylene-glycol (żewġ 30 kDa PEG) moiety.
English: Immunogenicity was evaluated during clinical trials with Jivi in 159 (including surgery patients) previously treated adolescents (≥ 12 years of age) and adults diagnosed with severe haemophilia A (FVIII:C < 1%), and ≥ 150 previous exposure days.
Maltese: Immunoġeniċità ġiet evalwata waqt provi kliniċi b'Jivi f'159 (inklużi pazjenti li għamlu kirurġija) adolexxenti li kienu ttrattati qabel (≥ 12-il sena) u adulti dijanjostikati b'emofilja A severa (FVIII:C < 1%), u ≥ 150 jum ta' esponiment minn qabel.
English: The median dose for prophylaxis was 47.7 IU/kg.
Maltese: Id-doża medjana għall-profilassi kienet ta' 47.7 IU/kg.
English: During the extension, 942 bleeds were treated with Jivi and 92.3% were controlled with 1 or 2 injections, thereof 83% with 1 injection.
Maltese: Matul l-estensjoni, 942 fsada kienu ttrattati b'Jivi u 92.3% kienu kkontrollati b'injezzjoni waħda jew 2, 83% minnhom b'injezzjoni waħda.
English: 80-100 (pre- and post-operative)
Maltese: 80-100 (qabel u wara l-kirurġija)
English: Frequency of doses (hours) / Duration of therapy (days)
Maltese: Frekwenza tad-dożi (sigħat) / Tul tat-terapija (ġranet)
English: AUC (IU.h/dL)*
Maltese: AUC (IU.siegħa/dL)* 3341 (34.2)
English: Interactions of human coagulation factor VIII (rDNA) products with other medicinal products have not been reported.
Maltese: Ma ġewx irrapportati interazzjonijiet ta' prodotti li fihom il-fattur VIII tal-koagulazzjoni uman (rDNA) ma' prodotti mediċinali oħrajn.
English: Required units = body weight (kg) x desired factor VIII rise (% or IU/dL) x reciprocal of observed recovery (i.e. 0.5 for recovery of 2.0%).
Maltese: Unitajiet meħtieġa = piż tal-ġisem (kg) x żieda mixtieqa ta' fattur VIII (% jew IU/dL) x reċiproku talirkupru osservat (i.e. 0.5 għal irkupru ta' 2.0%).
English: AUC: area under the curve; AUC, norm: dose normalized AUC Cmax: maximum drug concentration; , t½: terminal half¬life; MRT IV : mean residence time after an intravenous administration; VSS: apparent volume distribution at steady¬state; CL: clearance
Maltese: AUC, norm: AUC normalizzata għad-doża; Cmax: konċentrazzjoni massima talmediċina; t½: half-life terminali;
English: Table 4: PK parameters (geometric mean [%CV]) based on population PK model, using chromogenic assay.
Maltese: Tabella 4: Parametri tal-PK (medja ġeometrika [% CV]) abbażi ta' mudell tal-PK talpopolazzjoni, bl-użu ta' analiżi kromoġenika.
English: Damoctocog alfa pegol does not contain von Willebrand factor.
Maltese: Damoctocog alfa pegol ma fihx il-fattur von Willebrand.
English: Forty-two out of 110 in the prophylaxis arms (38.2%) experienced no bleeding episode.
Maltese: Tnejn u erbgħin minn 110 fil-gruppi ta' profilassi (38.2%) ma kellhom l-ebda episodju ta' fsada.
English: No cross-reactivity of anti-PEG IgM antibodies with other unmodified factor VIII products was observed.
Maltese: Ma kienet osservata l-ebda reattività reċiproka ta' antikorpi anti-PEG IgM ma' prodotti oħra mhux modifikati ta' FVIII.
English: The total number of exposure days (ED) was 18432 with a median of 131 ED (range: 1 to 309) per subject; median time in study for paediatric patients < 12 years was 237 days with a total of 3219 ED and median of 53 ED (range 1-68) per subject.
Maltese: In-numru totali ta' ġranet ta' esponiment (ED - exposure days) kien ta' 18,432 b'medjan ta' 131 ED (medda: 1 sa 309) għal kull individwu; iż-żmien medjan fl-istudju għal pazjenti pedjatriċi b'età < 12-il snin kien ta' 237 ġurnata b'total ta' 3,219 ED u medjan ta' 53 ED (medda 1-68) għal kull individwu.
English: Hypersensitivity reactions could also be related to antibodies against PEG (see paragraph Immune response to polyethylene glycol (PEG)).
Maltese: Reazzjonijiet ta' sensittività eċċessiva jistgħu jkunu relatati wkoll ma' antikorpi kontra PEG (ara l-paragrafu Rispons immuni għal polyethylene glycol (PEG)).
English: Table 1: Guide for dosing in bleeding episodes and surgery for adolescents and adults
Maltese: Tabella 1: Gwida għad-dożaġġ waqt episodji ta' fsada u kirurġija għall-adolexxenti u l-adulti
English: A total of 121 subjects received treatment during the extension study with a median duration of 464 days.
Maltese: Total ta' 121 individwu rċevew trattament matul listudju ta' estensjoni b'tul medjan ta' 464 jum.
English: A total of 232 previously treated patients with severe haemophilia A have been exposed in the clinical trial program which included one phase I study and two phase II/III studies.
Maltese: Total ta' 232 pazjent ittrattati qabel b'emofilja A severa kienu esposti fil-programm ta' prova klinika li kien jinkludi studju wieħed ta' fażi I u żewġ studji ta' fażi II/III.
English: One-hundred and fifty nine (159) subjects were ≥ 12 years of age,
Maltese: Mija u disa' u ħamsin (159) individwu kellhom età ta' ≥ 12-il sena.
English: A total of 221 patients constituted the safety population from three pivotal Phase I and III studies [PROTECT VIII].
Maltese: Total ta' 221 pazjent ikkostitwixxew il-popolazzjoni tas-sigurtà minn tliet studji pivotali ta' Fażi I u III [PROTECT VIII].
English: A clinical immune response associated with anti-PEG antibodies, manifested as symptoms of acute hypersensitivity and/or loss of drug effect has been observed primarily within the first 4 exposure days.
Maltese: Rispons immuni kliniku assoċjat ma' antikorpi anti-PEG, li ġie manifestat bħala sintomi ta' sensittività eċċessiva akuta u/jew telf ta' effett tal-mediċina ġie osservat primarjament fl-ewwel 4 ijiem ta' esponiment.
English: The required dose of Jivi is determined using the following formula:
Maltese: Id-doża meħtieġa ta' Jivi hija determinata permezz ta' din il-formula:
English: 1 vial with powder, 1 pre-filled syringe with 2.5 mL water for injections, 1 vial adapter and 1 venipuncture set.
Maltese: Kunjett 1 bi trab, siringa 1 mimlija għal-lest b'2.5 mL ilma għall-injezzjonijiet, adapter tal-kunjett 1 u sett 1 biex ittaqqab il-vina.
English: The PEG-linker moiety was also tested in a standard set of in vivo and in vitro genotoxicity studies and they did not indicate a potential for genotoxicity.
Maltese: Il-frazzjoni PEG-linker ġiet ittestjata wkoll f'sett standard ta' studji in vivo u in vitro dwar ilġenotossiċità u ma indikawx potenzjal ta' ġenotossiċità.
English: The clinical effect of factor VIII is the most important element in evaluating the effectiveness of treatment.
Maltese: L-effett kliniku tal-fattur VIII huwa l-aktar element importanti fl-evalwazzjoni tal-effettività tattrattament.
English: 1 multipack with 30 single packs.
Maltese: Daqsijiet tal-Pakkett pakkett ta' wieħed. pakkett multiplu bi 30 pakkett ta' wieħed.
English: Table 3: Pharmacokinetic parameters (geometric mean (%CV) and arithmetic mean (SD)) for Jivi following a single 60 IU/kg dose based on chromogenic assay.
Maltese: Tabella 3: Parametri farmakokinetiċi (medja ġeometrika (%CV) u medja aritmetika (SD)) għal Jivi wara doża waħda ta' 60
English: Pharmacotherapeutic group: antihaemorrhagics: blood coagulation factor VIII, ATC code: B02BD02.
Maltese: Kategorija farmakoterapewtika: mediċini kontra emorraġija fattur VIII tal-koagulazzjoni tad-demm, Kodiċi ATC:
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedima, ħruq u tingiż fis-sit tal-injezzjoni,tertir ta' bard, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, dardir, nuqqas ta' kwiet, takikardija, għafis fis-sider, tnemnim, rimettar, tħarħir) ġew osservati u f'xi każijiet jistgħu jiżviluppaw f'anafilassi severa (li tinkludi xokk).
English: In 3 of 44 patients (7%), loss of drug effect was combined with hypersensitivity reactions (see section 4.4).
Maltese: Fi 3 minn 44 pazjent (7%), it-telf tal-effett tal-mediċina kien ikkombinat ma' reazzjonijiet ta' sensittività eċċessiva (ara sezzjoni 4.4).
English: Cough common
Maltese: Sogħla komuni
English: • 60 IU per kg body weight every 7 days or
Maltese: IU/kg u kull 7 ijiem 60
English: Site-specific PEGylation reduces clearance of factor VIII resulting in an extended half-life while maintaining the normal functions of the B-domain deleted rFVIII molecule (see section 5.2).
Maltese: PEGylation speċifika għas-sit tnaqqas ittneħħija tal-fattur VIII u twassal għal half-life itwal waqt li żżomm il-funzjonijiet normali tal-molekula rFVIII b'dominju B imħassar (ara sezzjoni 5.2).
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified Bethesda assay.
Maltese: IgG, li jaġixxu kontra l-attività prokoagulanti tal-fattur VIII, u jiġu mkejla f'Unitajiet Bethesda (BU - Bethesda Units) għal kull mL ta' plażma bl-użu tal-analiżi modifikata Bethesda.
English: Each vial of Jivi contains nominally 250 or 500 or 1000 or 2000 or 3000 IU damoctocog alfa pegol.
Maltese: Kull kunjett ta' Jivi fih mill-inqas 250 jew 500 jew 1,000 jew 2,000 jew 3,000 IU damoctocog alfa pegol.
English: Jivi 1000 IU contains 400 IU damoctocog alfa pegol per mL after reconstitution (1000 IU / 2.5 mL).
Maltese: IU fih 400 IU damoctocog alfa pegol f'kull mL wara r-rikostituzzjoni (1000 IU / 2.5 mL).
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta' min jinnota, li l-ABR mhix komparabbli bejn konċentrati ta' fatturi differenti u bejn studji kliniċi differenti.
English: The potency International Unit (IU) is determined using the European Pharmacopoeia chromogenic assay.
Maltese: L-Unità Internazzjonali (IU - International Unit) tal-qawwa hija stabbilita permezz ta' assay kromoġeniku tal-Farmakopea Ewropea.
English: Jivi 250 IU contains 100 IU damoctocog alfa pegol per mL after reconstitution (250 IU / 2.5 mL).
Maltese: IU fih 100 IU damoctocog alfa pegol f'kull mL wara r-rikostituzzjoni (250 IU / 2.5 mL).
English: A significant decrease in the risk of an immune response to PEG was observed with an increase in age.
Maltese: Ġie osservat tnaqqis sinifikanti fir-riskju ta' rispons immuni għal PEG b'żieda fl-età.
English: Sixty one subjects (83.6%) completed the main study and 59 patients continued in the optional extension study.
Maltese: Wieħed u sittin individwu (83.6%) lestew l-istudju prinċipali u 59 pazjent komplew flistudju ta' estensjoni mhux obbligatorju.