FrancophonIA/ELRC3.0 huggingface dataset:
English: For 53 patients who completed the main study, the median (Q1; Q3) annualised bleeding rate was 2.87 (1.1; 6.1) and the spontaneous ABR was 0.0 (0.0; 2.6).
Maltese: Għal 53 pazjent li temmew l-istudju prinċipali, ir-rata annwali medjana (Q1; Q3) ta' fsada kienet ta' 2.87 (1.1; 6.1) u l-ABR spontanja kienet ta' 0.0
English: Degree of haemorrhage/Type of surgical procedure
Maltese: Qawwa tal-emorraġija/ Tip ta' proċedura kirurġika
English: A total of 73 previously treated pediatric patients (44 subjects < 6 years and 29 subjects 6 to <12 years) received prophylaxis treatment twice weekly, every 5 days or every 7 days in the phase III study.
Maltese: Total ta' 73 pazjent pedjatriku li kienu ttrattati qabel (44 individwu < 6 snin u 29 individwu6 sa <12-il sena) rċevew trattament ta' profilassi darbtejn fil-ġimgħa, kull 5 ijiem jew kull 7 ijiem flistudju ta' fażi
English: • allergic to damoctocog alfa pegol or any of the other ingredients of this medicine (listed in section 6).
Maltese: • allerġiku għal damoctocog alfa pegol jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6).
English: Paediatric population < 12 years of age
Maltese: Popolazzjoni pedjatrika b'età ta' < 12-il sena
English: This is of importance when monitoring the factor VIII activity of Jivi, and when changing laboratory and/or reagents used in the assay.
Maltese: Dan huwa ta' importanza waqt il-monitoraġġ tal-attività tal-fattur VIII ta' Jivi, u meta jinbidel il-laboratorju u/jew ir-reaġenti użati fl-analiżi.
English: During the extension study, 24 patients were treated 2x/week, 37 patients every 5-days, 29 patients every 7 days and 17 patients changed treatment regimen.
Maltese: Matul l-istudju ta' estensjoni, 24 pazjent ġew ittrattati 2x/ġimgħa, 37 pazjent kull 5 ijiem, 29 pazjent kull 7 ijiem u 17-il pazjent bidlu l-kors tat-trattament.
English: • nettle¬rash, flushing
Maltese: • raxx b'ħorriqija, fwawar
English: Repeat injection every 8 to 24 hours until threat is resolved.
Maltese: Irrepeti l-injezzjoni kull 8 sa 24 siegħa sakemm tgħaddi t-theddida.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Jivi (see section 5.1).
Maltese: L-iżvilupp ta' antikorpi newtralizzanti (inibituri) jista' jseħħ f'pazjenti bl-emofilja A ttrattati bilfattur VIII, inkluż b'Jivi (ara sezzjoni 5.1).
English: Dizziness common
Maltese: Disgewżja mhux komuni
English: Hemostasis during 20 major surgeries in 17 patients was evaluated in the surgery part.
Maltese: Emostażi waqt 20 kirurġija maġġuri fi 17il pazjent kienet evalwata fil-parti tal-kirurġija.
English: Headache very common
Maltese: Ħakk mhux komuni
English: In 10 of 44 patients (23%) in the age group of younger than 6 years of age loss of drug effect due to neutralising anti-PEG antibodies during the first 4 exposure days was observed.
Maltese: F'10 minn 44 pazjent (23%) fil-grupp ta' età iżgħar minn 6 snin, ġie osservat telf tal-effett tal-mediċina minħabba antikorpi newtralizzanti anti-PEG matul l-ewwel 4 ijiem ta' esponiment.
English: Manufacturer Bayer AG
Maltese: Il-Manifattur Bayer AG
English: The PK data (based on chromogenic assay) indicated that Jivi has a reduced clearance (CL), resulting in a terminal half-life that is 1.4-fold longer and a dose normalized AUC which is 1.4-fold higher, as compared to the comparative factor VIII product.
Maltese: Id-data tal-PK (ibbażata fuq analiżi kromoġenika) indikat li Jivi għandu tneħħija (CL - clearance), imnaqqsa li twassal għal half-life terminali li hija 1.4 darbiet itwal u AUC li hija normalizzata b'doża li hija 1.4 darbiet ogħla meta mqabbla mal-prodott ta' paragun li fih fattur VIII. Żidiet proporzjonali mad-doża kienu osservati bejn id-dożi ta' 25 u 60
English: Dose proportional increases were observed between the doses of 25 and 60 IU/kg indicating dose linearity between 25 IU/kg and 60 IU/kg.
Maltese: IU/kg li jindikaw linearità tad-doża bejn 25 IU/kg u 60
English: • 45-60 IU per kg body weight every 5 days or
Maltese: IU/kg, kull 5 ijiem 45-60
English: The immune response was accompanied by a clinical hypersensitivity reaction after 4 injections of Jivi.
Maltese: Ir-rispons immuni kien akkumpanjat minn reazzjoni klinika ta' sensittività eċċessiva wara 4 injezzjonijiet ta' Jivi.
English: May be stored at temperatures up to 25 °C for up to 6 months within the expiry date indicated on the label.
Maltese: Jista' jinħażen f'temperaturi sa 25°C għal perjodu sa 6 xhur sad-data ta' skadenza indikata fuq ittikketta.
English: Solvent: clear solution.
Maltese: Solvent: soluzzjoni ċara.
English: The median total dose for major surgeries was 219 IU/kg (range: 50-1500 IU/kg, including postoperative period up to 3 weeks).
Maltese: Id-doża totali medjana għal kirurġiji maġġuri kienet ta' 219 IU/kg (firxa: 50-1500
English: The use of Jivi in children below 12 years is not indicated (see section 4.2, for information on paediatric use).
Maltese: L-użu ta' Jivi mhuwiex indikat fit-tfal b'età ta' inqas minn 12-il sena (ara sezzjoni 4.2, għal informazzjoni dwar l-użu pedjatriku).
English: Remove the protective cap from the vial (A).
Maltese: Neħħi l-għatu protettiv mill-kunjett (A).
English: Data show that in the affected subjects, following discontinuation of Jivi, the anti-PEG IgM antibodies decreased in titre and became undetectable over time .
Maltese: Data turi li f'individwi affettwati, wara t-twaqqif ta' Jivi, l-antikorpi anti-PEG IgM, naqsu fit-titre u maż-żmien ma baqgħux jiġu osservati.
English: In completed clinical studies with 73 paediatric PTPs < 12 years (44 PTPs < 6 years, 29 PTPs 6¬<12 years), adverse reactions due to immune response to PEG were observed in children less than
Maltese: PTPs < 6 snin, 29 PTPs 6-< 12-il sena), reazzjonijiet avversi minħabba rispons immuni għal PEG kienu osservati fit-tfal b'età ta' inqas minn 6 snin.
English: Jivi is used to treat and prevent bleeding in previously treated adults and adolescents aged from 12 years with haemophilia A (hereditary factor VIII deficiency).
Maltese: Jivi jintuża biex jittratta u jipprevjeni fsada f'adulti u adolexxenti ttrattati minn qabel b'età minn 12-il sena 'l fuq bl-emofilja A (defiċjenza ereditarja tal-fattur VIII).
English: *AUC calculated for a dose of 60 IU/kg
Maltese: *AUC ikkalkulata għal doża ta' 60
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Maltese: Il-kumpless tal-fattur VIII/fattur von Willebrand huwa magħmul minn żewġ molekuli (fattur VIII u lfattur von Willebrand) li għandhom funzjonijiet fiżjoloġiċi differenti.
English: The median (range) dose was 37.3 (18; 66) IU/kg/injection.
Maltese: Id-doża medjana (firxa) kienet ta' 37.3 (18; 66)
English: Injection site reactions **, Pyrexia common * Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A. PTPs = previously-treated patients” **includes injection site pruritus, injection site rash and vessel puncture site pruritus ***includes erythema and erythema multiforme ****includes rash and rash papular
Maltese: PTPs = pazjenti ttrattati qabel **jinkludu ħakk fis-sit tal-injezzjoni, raxx fis-sit tal-injezzjoni u ħakk fis-sit fejn ittaqbet il-vina ***tinkludi eritema u eritema multiforme ****jinkludi raxx u raxx bl-infafet
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Maltese: Jekk strument ta' aċċess venuż ċentrali (CVAD - central venous access device) ikun meħtieġ, ir-riskju ta' komplikazzjonijiet relatati ma' CVAD inkluż infezzjonijiet lokali, batteremija u trombożi fis-sit talkateter, għandu jiġi kkunsidrat.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 1.5-2.5 % of normal activity.
Maltese: IU waħda ta' fattur VIII għal kull kg ta' piż tal-ġisem, tgħolli l-attività ta' fattur VIII fil-plażma b'1.5 sa 2.5% talattività normali.
English: During the main study period subjects were assigned to prophylaxis 2x/week (n=24), or randomized to every 5 days (n=43) or every 7 days (n=43) or received on-demand treatment (n=20) with Jivi.
Maltese: Matul il-perjodu tal-istudju prinċipali l-individwi ġew assenjati għal profilassi 2x/ġimgħa (n=24), jew randomised għal kull 5 ijiem (n=43) jew kull 7 ijiem (n=43) jew irċevew trattament fil-pront (n=20) b'Jivi.
English: Jivi 1000 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 400 IU (1000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Wara r-rikostituzzjoni bis-solvent ipprovdut, mL wieħed ta' soluzzjoni fih madwar 400 IU (1000 IU/2.5 mL) ta' fattur VIII tal-koagulazzjoni uman, damoctocog alfa pegol.
English: Phase III (Paediatric): Pharmacokinetics, safety, and efficacy of Jivi for three prophylaxis regimens (twice weekly, every 5 and every 7 days) and treatment of breakthrough bleeds were evaluated in a multi-national, uncontrolled, open-label trial in 73 paediatric patients (<12 years of age) during a period of 50 EDs and at least 6 months.
Maltese: Il-farmakokinetika, is-sigurtà u l-effikaċja ta' Jivi għal tliet korsijiet ta' profilassi (darbtejn fil-ġimgħa, kull 5 ijiem u kull 7 ijiem) u t-trattament ta' fsad li jseħħ minkejja trattament kienu evalwati fi prova multi-nazzjonali, mhux ikkontrollata, open-label fi 73 pazjent pedjatriku (età ta' <12-il sena) matul perjodu ta' 50 ED u għal mill-inqas 6 xhur.
English: PK parameter(unit) 12-<18 years N=12
Maltese: 12-<18-il sena N=12
English: • stomach pain
Maltese: • batterji fid-demm
English: One hundred and thirty four male PTPs received at least one injection of Jivi (including 13 subjects aged 12 to 17 years of age) for prophylaxis (n=114) or on-demand treatment (n=20) for a period of 36 weeks.
Maltese: Mija u erbgħa u tletin PTPs irġiel irċevew mill-inqas injezzjoni waħda ta' Jivi (inklużi 13-il individwu b'età ta' 12 sa 17-il sena) għal profilassi (n=114) jew trattament fil-pront (n=20) għal perjodu ta' 36 ġimgħa.
English: The active substance is PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol).
Maltese: Is-sustanza attiva hi fattur VIII tal-koagulazzjoni rikombinanti uman, PEGilat, b'dominju B imħassar (damoctocog alfa pegol).
English: PC SN NN
Maltese: Jekk tinsa tuża Jivi
English: For patients who have received previous treatment with factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients).
Maltese: Għal pazjenti li rċevew trattament minn qabel bil-fattur VIII (aktar minn 150 jum ta' trattament) jistgħu jiffurmaw antikorpi inibituri (ara sezzjoni 2) b'mod mhux komuni (inqas minn wieħed minn kull 100 pazjent).
English: EU/1/18/1324/006 - 30 x (Jivi 250 IU)
Maltese: EU/1/18/1324/006 - 30 x (Jivi 250
English: PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Maltese: Fattur VIII tal-koagulazzjoni rikombinanti uman, PEGilat, b'dominju B imħassar (damoctocog alfa pegol)
English: Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Jivi 2,000 IU trab u solvent għal soluzzjoni għall-injezzjoni Jivi 3,000 IU trab u solvent għal soluzzjoni għall-injezzjoni
English: Other medicines and Jivi
Maltese: Mediċini oħra u Jivi
English: In the repeat dose systemic toxicity studies in rats and rabbits with Jivi, treatment related effects on male reproductive organs were not seen (see section 5.3).
Maltese: Fi studji dwar tossiċità sistemika minn dożi ripetuti fil-firien u l-fniek b'Jivi, ma kinux osservati effetti relatati mat-trattament fuq l-organi riproduttivi maskili (ara sezzjoni 5.3). L-effett fuq il-fertilità filbnedmin mhux magħruf.
English: • one pre-filled syringe with 2.5 mL solvent (clear type 1 glass cylinder syringe with grey bromobutyl rubber blend stopper)
Maltese: • siringa waħda mimlija għal-lest b'2.5 mL ta' solvent (siringa ċilindru trasparenti ta' tip 1
English: Median time on study was 713 days with a median of 131 exposure days (range: 1 to 309 days).
Maltese: Iż-żmien medjan fl-istudju kien ta' 713-il ġurnata b'medjan ta' 131 jum ta' esponiment (firxa: 1 sa 309 ijiem).
English: EU/1/18/1324/009 - 30 x (Jivi 2000 IU)
Maltese: EU/1/18/1324/009 - 30 x (Jivi 2000
English: These may be signs of a rare severe sudden allergic reaction to this medicine.
Maltese: Dawn jistgħu jkunu sinjali ta' reazzjoni allerġika rari, severa f'daqqa għal din il-mediċina.
English: EU/1/18/1324/004 -1 x ( Jivi 2000 IU)
Maltese: EU/1/18/1324/004 - 1 x (Jivi 2000
English: INSTRUCTIONS ON USE
Maltese: Inibituri ta' FVIII
English: EU/1/18/1324/007 - 30 x (Jivi 500 IU)
Maltese: EU/1/18/1324/007 - 30 x (Jivi 500
English: It is not for use in children younger than 12 years of age.
Maltese: Tfal Jivi mhux għal użu fit-tfal ta' età iżgħar minn 12-il sena.
English: EU/1/18/1324/008 - 30 x (Jivi 1000 IU)
Maltese: EU/1/18/1324/008 - 30 x (Jivi 1000
English: EU/1/18/1324/001 - 1 x (Jivi 250 IU)
Maltese: EU/1/18/1324/001 - 1 x (Jivi 250
English: Repeat injection every 24-48 hours for 3 to 4 days or more until pain and acute disability are resolved.
Maltese: Irrepeti l-injezzjoni kull 24-48 siegħa għal 3 sa 4 ijiem jew aktar, sakemm jgħaddu l-uġigħ u d-diżabilità akuta.
English: • itching
Maltese: • sturdament
English: Jivi 3000 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Maltese: Jivi 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni Fattur VIII tal-koagulazzjoni rikombinanti uman, PEGilat, b'dominju B imħassar (damoctocog alfa pegol)
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Maltese: Hu indispensabbli li fil-każ ta' interventi kirurġiċi maġġuri, ikun hemm monitoraġġ preċiż tat-terapija ta' sostituzzjoni, permezz tal-analiżi talkoagulazzjoni (l-attivà tal-fattur VIII fil-plażma).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: • one syringe plunger rod
Maltese: • is-severità tal-emofilja A tiegħek
English: Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection
Maltese: Jivi 2,000 IU trab u solvent għal soluzzjoni għall-injezzjoni Jivi 3,000 IU trab u solvent għal soluzzjoni għall-injezzjoni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/006 - 30 x (Jivi 250 IU)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1324/006 - 30 x (Jivi 250
English: The median (Q1; Q3) ABR during prophylaxis was 2.09 (0.0; 6.1) for all bleeds and 0.0 (0;0 4.2) for spontaneous bleeds as compared to 23.4 (18; 37) total bleeds in the on-demand group.
Maltese: (0.0; 4.2) għall-fsadiet spontanji meta mqabbel ma' 23.4 (18; 37) fsadiet totali fil-grupp ta' trattament fil-pront.
English: EU/1/18/1324/002 - 1 x (Jivi 500 IU)
Maltese: EU/1/18/1324/002 - 1 x (Jivi 500
English: Children Jivi is not for use in children younger than 12 years of age.
Maltese: Dan mhuwiex għal użu fi tfal ta' età iżgħar minn 12-il sena.
English: EU/1/18/1324/003 - 1 x (Jivi 1000 IU)
Maltese: EU/1/18/1324/003 - 1 x (Jivi 1000
English: For Jivi some silica-based one-stage assays (e.g., APTT-SP, STA-PTT) may underestimate the factor VIII activity of Jivi in plasma samples; some reagents, e.g. with kaolin-based activators, have the potential for overestimation.
Maltese: Għal Jivi xi testijiet ibbażati fuq is-silika ta' fażi waħda (eż., APTT-SP, STA-PTT) jistgħu jissottovalutaw l-attività talfattur VIII ta' Jivi f'kampjuni tal-plażma; xi reaġenti, eż. b'attivaturi bbażati fuq kaolin għandhom ilpotenzjal ta' stima żejda.
English: Jivi is not known to influence or be influenced by other medicines.
Maltese: Jivi mhux magħruf li jinfluwenza jew jiġi influwenzat minn mediċini oħra.
English: • one vial with powder (10 mL clear type 1 glass vial with grey bromobutyl rubber blend stopper and aluminium seal)
Maltese: • kunjett wieħed bit-trab (kunjett tat-tip 1 magħmul minn ħġieġ trasparenti ta' 10 mL b'tapp griż magħmul minn taħlita ta' gomma bromobutyl u siġill tal-aluminju)
English: The pharmacokinetics (PK) of Jivi was compared to that of factor VIII in a crossover Phase I study.
Maltese: Il-farmakokinetika (PK - pharmacokinetics) ta' Jivi kienet imqabbla ma' dik tal-fattur VIII fi studju crossover ta' Fażi I.
English: PHARMACEUTICAL FORM AND CONTENTS powder and solvent for solution for injection.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT trab u solvent għal soluzzjoni għall-injezzjoni.
English: Pack sizes 1 single pack.
Maltese: Kull pakkett ta' wieħed ta' Jivi fih
English: Post Authorisation Safety Study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a noninterventional post-authorisation safety study according to an agreed protocol.
Maltese: Sabiex jiġu investigati leffetti potenzjali tal-akkumulazzjoni ta' PEG fil-plexus korojdali tal-moħħ u ta' tessuti/organi oħra, l-MAH għandu jwettaq u jissottometti r-riżultati ta' studju mhux intervenzjonali dwar is-sigurta wara l-awtorizzazzjoni skont protokoll miftiehem.
English: • allergic reactions (may present as hives, generalized urticaria, tightness of the chest, wheezing,
Maltese: • reazzjonijiet allerġiċi (jistgħu jidrhu bħala urtikarja, urtikarja ġeneralizzata, tagħfis tas-sider,
English: A single unconfirmed positive result of a low titre of factor VIII inhibitor (1.7 BU/mL) was reported in one adult patient following a surgery.
Maltese: Riżultat pożittiv wieħed mhux ikkonfermat ta' titru baxx ta' inibitur ta' FVIII (1.7 BU/mL) kien irrappurtat f'pazjent adult wieħed wara kirurġija.
English: • feeling sick (nausea)
Maltese: MRTIV (siegħa)
English: • a separate plunger rod
Maltese: • il-piż tiegħek
English: Low post-injection factor VIII levels in the absence of detectable factor VIII inhibitors indicate that loss of drug effect is likely due to anti-PEG antibodies; in such cases Jivi should be discontinued and patients switched to a previously effective factor VIII product.
Maltese: Livelli baxxi ta' FVIII wara l-injezzjoni fin-nuqqas ta' inibituri ta' FVIII li jistgħu jiġu osservati jindikaw li t-telf tal-effett tal-mediċina x'aktarx huwa dovut għal antikorpi anti-PEG; f'każijiet bħal dawn Jivi għandu jitwaqqaf u l-pazjenti għandhom jinqalbu għal prodott ta' FVIII li qabel kien effettiv.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/007 - 30 x (Jivi 500 IU)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1324/007 - 30 x (Jivi 500
English: Allergic type hypersensitivity reactions are possible with Jivi.
Maltese: L-aktar effetti sekondarji serji huma reazzjonijiet allerġiċi jew reazzjoni allerġika severa.
English: Immunogenicity against PEG with development of specific IgM anti-PEG antibodies was observed in one patient.
Maltese: IgM anti-PEG speċifiċi ġiet osservata f'pazjent wieħed.
English: • tightness in the chest, fall in blood pressure (often shown by feeling dizzy when getting up quickly), itchy nettle-rash, wheezing, feeling sick or faint.
Maltese: • reazzjonijiet lokali fis-sit tal-injezzjoni bħal fsada taħt il-ġilda, ħakk intens, nefħa, sensazzjoni ta' ħruq, ħmura temporanja
English: A population PK model was developed based on all available factor VIII measurements (from dense PK sampling and all recovery samples) throughout the 3 clinical studies allowing calculation of PK parameters for subjects in the various studies.
Maltese: B'mod ġenerali l-pazjenti kollha ttrattati bi prodotti tal-koagulazzjoni li fihom il-fattur VIII, għandhom jiġu ssorveljati bir-reqqa għall-iżvilupp ta' inibituri permezz ta' osservazzjonijiet kliniċi u testijiet tal-laboratorju xierqa.
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Maltese: F'pazjenti b'fatturi ta' riskju kardjovaskulari eżistenti, terapija ta' sostituzzjoni b'FVIII tista' żżid irriskju kardjovaskulari.
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Maltese: Ir-rilevanza klinika tal-iżvilupp tal-inibituri se tiddependi fuq it-titru tal-inibitur, b'inibituri ta' titru baxx ikollhom inqas riskju ta' rispons kliniku insuffiċjenti minn inibituri b'titru għoli.
English: • a pre-filled syringe of solvent
Maltese: • siringa mimlija għal-lest tas-solvent
English: Jivi 2000 IU contains 800 IU damoctocog alfa pegol per mL after reconstitution (2000 IU / 2.5 mL).
Maltese: IU fih 800 IU damoctocog alfa pegol f'kull mL wara r-rikostituzzjoni (2000
English: The protein in damoctocog alfa pegol has been modified (pegylated) to prolong its action in the body.
Maltese: Ilproteina f'damoctocog alfa pegol ġiet modifikata (pegilata) biex titwal l-azzjoni tagħha fil-ġisem.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in IU (relative to an International Standard for factor VIII in plasma).
Maltese: L-attività tal-fattur VIII fil-plażma hija mfissra bħala persentaġġ (imqabbla ma' plażma normali tal-bniedem), jew preferibbilment bħala IU (imqabbla ma' Standard Internazzjonali għal fattur VIII fil-plażma).
English: • bleeding that is not being controlled with your usual dose of this medicine.
Maltese: • fsada li ma tkunx qed tiġi kkontrollata bid-doża tiegħek tas-soltu ta' din il-mediċina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/008 - 30 x (Jivi 1000 IU)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1324/008 - 30 x (Jivi 1000
English: Table 3 summarizes the PK parameters after single dose of 60 IU/kg from the Phase II/III study where PK was evaluated in 22 subjects.
Maltese: II/III fejn il-PK ġiet evalwata fi 22 individwu.
English: Jivi powder should only be reconstituted with the supplied solvent (2.5 mL water for injections) in the prefilled-syringe and the vial adapter.
Maltese: Trab ta' Jivi għandu jiġi rikostitwit biss bis-solvent ipprovdut (2.5 mL ta' ilma għall-injezzjonijiet) fis-siringa mimlija għal-lest u l-adapter tal-kunjett.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU (damoctocog alfa pegol).
Maltese: IU/2.5 mL) ta' fattur VIII tal-koagulazzjoni uman, damoctocog alfa pegol.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Jivi 500 IU powder for solution for injection
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Jivi 500
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI 2.5 mL
English: Jivi 500 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Fattur VIII tal-koagulazzjoni rikombinanti uman, PEGilat, b'dominju B imħassar (damoctocog alfa pegol)