FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Frequency of adverse drug reactions in clinical trials MedDRA Standard
Maltese: Tabella 2: Frekwenza ta' reazzjonijiet avversi għall-mediċina fil-provi kliniċi Standard MedDRA
English: Remove tourniquet.
Maltese: Neħħi t-turnikett.
English: Abdominal pain, abdominal discomfort, dyspepsia common
Maltese: Uġigħ addominali, skonfort addominali, dispepsja komuni
English: Apply a tourniquet to your arm. 14.
Maltese: 13. Applika turnikett fi driegħek. 14.
English: The specific activity of Iblias is approximately 4000 IU/mg protein.
Maltese: L-attività speċifika ta' Iblias hija madwar 4,000 IU/mg ta' proteina.
English: Each vial contains nominally 250/500/1000/2000/3000 IU human coagulation factor VIII.
Maltese: Kull kunjett nominalment fih 250/500/1,000/2,000/3,000 IU ta' fattur VIII tal-koagulazzjoni umana.
English: Each vial of Iblias contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa.
Maltese: Kull kunjett ta' Iblias fih nominalment 250, 500, 1,000, 2,000 jew 3,000 IU octocog alfa.
English: Table 4: PK parameters (geometric mean (%CV)) based on chromogenic assay.
Maltese: Tabella 4: Parametri PK (medja ġeometrika (%CV)) ibbażati fuq assaġġ kromoġeniku.
English: LIST OF EXCIPIENTS Sucrose, histidine, glycine, sodium chloride, calcium chloride, polysorbate 80.
Maltese: TA' EĊĊIPJENTI Sucrose, histidine, glycine, sodium chloride, calcium chloride, polysorbate 80.
English: The active substance is human coagulation factor VIII (octocog alfa).
Maltese: Is-sustanza attiva hi l-fattur VIII rikombinanti tal-koagulazzjoni umana (octocog alfa).
English: Factor VIII level required (%) (IU/dL)
Maltese: Livell ta'fattur VIII meħtieġ (%) (IU/dL)
English: 12-<18 years N=23
Maltese: 12-< 18-il sena N=23
English: Consistent results were determined for both products.
Maltese: Riżultati konsistenti ġew determinati għaż-żewġ prodotti.
English: Repeat infusion every 8 to 24 hours until threat is resolved
Maltese: Irrepeti l-infużjoni kull 8 sa 24 siegħa sakemm tieqaf ittheddida.
English: Iblias can be used for all age groups.
Maltese: Iblias jista' jintuża għall-gruppi kollha ta' età.
English: 0-<6 years N=24
Maltese: 0-< 6-il sena N=24
English: Q1 first quartile; Q3 third quartile
Maltese: Q3 it-tielet quartile
English: 6-<12 years N=27
Maltese: 6-< 12-il sena N=27
English: (Also FVIII is an intrinsic protein and not known to cause any reproductive or carcinogenic effects.)
Maltese: (Ukoll, FVIII hi proteina intrinsika u mhix magħrufa li tikkawża kwalunkwe effetti riproduttivi jew karċinoġeniċi.)
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-klassifika tal-organi MedDRA (SOC u Livell ta' Terminu Preferut).
English: Chromogenic assay results Median; (Q1; Q3) (IU/dL / IU/kg) One-stage assay results Median; (Q1; Q3) (IU/dL / IU/kg)
Maltese: Q3) (IU/dL / IU/kg) Riżultati tal-assaġġ bi stadju wieħed Medjan; (Q1; Q3) (IU/dL / IU/kg)
English: 1 F. Peyvandi et al. “A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A” N Engl J Med. 2016 May 26;374(21):2054-64)
Maltese: Peyvandi et al. “A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A” N Engl J Med. 2016
English: Frequencies have been evaluated according to the following convention: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-frekwenzi ġew evalwati skont il-konvenzjoni li ġejja: komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100).
English: 4 Iorio A, Barbara AM, Makris M, Fischer K, Castaman G, Catarino C, Gilman E, Kavakli K, Lambert T, Lassila R, Lissitchkov T, Mauser-Bunschoten E, Mingot-Castellano ME0, Ozdemir N1, Pabinger I, Parra R1, Pasi J, Peerlinck K, Rauch A6, Roussel-Robert 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: R, Lissitchkov T, Mauser-Bunschoten E, Mingot-Castellano ME0, Ozdemir N1, Pabinger I, Parra R1, Pasi J, Peerlinck K, Rauch A6, Roussel-Robert V, Serban M, Tagliaferri A, Windyga J, Zanon E:
English: For 2000/3000 IU strength:
Maltese: Għall-qawwa ta' 2,000/3,000 IU:
English: Palpitation, sinus tachycardia common
Maltese: Palpitazzjoni, takikardija tas-sinus komuni
English: The RODIN/Pednet study3 also found no evidence of a class difference in inhibitor risk between all pdFVIII vs all rFVIII; for ‘clinically relevant' inhibitors the adjusted hazard ratio was 0.96 (95% CI 0.62-1.49), and for high titre inhibitors (≥5 BU/ml) was 0.95 (95% CI 0.56-1.61).
Maltese: L-istudju RODIN/Pednet ukoll ma sab l-ebda evidenza ta' differenza fil-klassi fir-riskju ta' inibituri bejn pdFVIII kollha vs rFVIII kollha; għall-inibituri “klinikament relevanti” il-proporzjon ta' riskju aġġustat kien ta' 0.96 (95% CI 0.62-1.49), u għall-inibituri ta' titre għoli (≥5 BU/ml) kien ta' 0.95 (95% CI 0.56-1.61).
English: T1/2 (h) AUC (IU.h/dL)** CL (dL/h/kg) Vss (dL/kg) * Based on population PK estimates **AUC calculated for a dose of 50 IU/kg
Maltese: AUC (IU.h/dL) CL (dL/h/kg) Vss (dL/kg)
English: ABR - all bleeds (median, Q1,Q3)
Maltese: ABR - il-ħruġ ta' demm kollu (medjan, Q1,Q3)
English: Skin and subcutaneous tissue disorders Pruritus, rash***, dermatitis allergic common
Maltese: Ħakk, raxx***, dermatite allerġika komuni
English: Determination of aPTT is a conventional in vitro assay for biological activity of factor VIII.
Maltese: Determinazzjoni ta' aPTT hu assaġġ konvenzjonali in vitro li jkejjel l-attività bijoloġika ta' fattur VIII.
English: Repeat infusion every 8 - 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).
Maltese: Irrepeti l-infużjoni kull 8 - 24 siegħa sa fejqan adegwat tal-ferita, u wara terapija għal mill-anqas 7 ijiem oħra biex tinżamm attività ta' fattur VIII ta' 30% sa 60% (IU/dL).
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Maltese: Thrombin ibiddel fibrinogen għal fibrin u b'hekk id-demm ikun jista' jagħqad.
English: The other ingredients are sucrose, histidine, glycine, sodium chloride, calcium chloride, polysorbate 80 (see end of section 2).
Maltese: Is-sustanzi l-oħra huma sucrose, histidine, glycine, sodium chloride, calcium chloride, polysorbate 80 (ara fit-tmiem ta' sezzjoni 2).
English: For 250/500/1000 IU strength:
Maltese: Għall-qawwa ta' 250/500/1,000 IU:
English: Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code: B02BD02
Maltese: Kategorija farmakoterapewtika: mediċini kontra emorraġija, fattur VIII tal-koagulazzjoni tad-demm, Kodiċi ATC:
English: 1 vial with powder.
Maltese: Kunjett wieħed bi trab.
English: Frequency of doses (hours)/ Duration of therapy (days)
Maltese: Frekwenza tad-dożi (sigħat)/ Dewmien tat-terapija (ġranet)
English: EU/1/15/1077/001 - Iblias 250 IU EU/1/15/1077/002 - Iblias 500 IU EU/1/15/1077/003 - Iblias 1000 IU EU/1/15/1077/004 - Iblias 2000 IU EU/1/15/1077/005 - Iblias 3000 IU
Maltese: IU EU/1/15/1077/004 - Iblias 2000
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
Maltese: ma sab l-ebda evidenza ta' differenza fil-klassi, inkluż prodotti pdFVIII bi kwantitajiet konsiderevoli tal-fattur von Willebrandl; għall-inibituri “klinikament relevanti” ilproporzjon 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 0.4-1.3).
English: • dysgeusia (strange taste)
Maltese: • disgewżja (togħma stramba)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 February 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18 ta' Frar 2016
English: 1 vial with 2.5 mL water for injections.
Maltese: Kunjett wieħed b'2.5 mL ilma għall-injezzjonijiet.
English: • an additional package with: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 mL syringe - 2 alcohol swabs for single use
Maltese: • pakkett addizzjonali b': - 1 tagħmir tat-trasferiment tal-filtru 20/20
English: Other medicines and Iblias
Maltese: Mediċini oħra u Iblias
English: • one vial with solvent (6 mL clear glass type 1 vial with grey chlorobutyl rubber blend stopper and aluminium seal)
Maltese: • kunjett wieħed bis-solvent (kunjett ta' 6 mL ta' ħġieġ trasparenti ta' tip 1 b'tapp blend griż talgomma tal-chlorobutyl u siġill tal-aluminju)
English: Since Iblias is a replacement protein of endogenous factor VIII, no adverse effects on fertility are expected.
Maltese: Billi Iblias hu proteina ta' sostituzzjoni ta' fattur VIII endoġenu, mhuma mistennija l-ebda effetti avversi fuq il-fertilità.
English: Iblias contains sodium
Maltese: Iblias fih is-sodium
English: • urticaria (itchy rash)
Maltese: • urtikarja (raxx bill-ħakk)
English: EXP (End of the 12 month period, if stored up to 25 °C): ........... Do not use after this date.
Maltese: EXP (Fi tmiem perijodu ta' 12-il xahar jekk maħżun f'temperatura sa 25°C): ...........
English: Iblias does not contain von Willebrand factor.
Maltese: Iblias ma fihx il-fattur von Willebrand.
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-2
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 żjieda mixtieqa ta' fattur VIII (% jew IU/dL) x reċiproku talirkupru osservat (i.e. 0.5 għal irkupru ta' 2.0%).
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, għandha tiġi mplimentata kura medika standard għal xokk.
English: In May 2016, an open-label, randomised controlled trial aimed at addressing the incidence of inhibitors between the two classes (pdFVIII vs. rFVIII products) was published in the New England Journal of Medicine1.
Maltese: F'Mejju 2016, prova open-label, randomizzata kkontrollata bl-għan li tindirizza l-inċidenza ta' inibituri bejn iż-żewġ klassijiet (prodotti pdFVIII vs. rFVIII) ġiet ippubblikata fin-New England
English: • one vial with powder (10 mL clear glass type 1 vial with grey halogenobutyl rubber blend stopper and aluminium seal)
Maltese: • kunjett wieħed bit-trab (kunjett ta' 10 mL ta' ħġieġ trasparenti ta' tip 1 b'tapp blend għatu griż tal-gomma tal-bromobutajl u siġill tal-aluminju).
English: Consequently, patients should be evaluated for cardiac risk factors.
Maltese: B'konsegwenza ta' dan, il-pazjenti għandhom jiġu evalwati għal fatturi ta' riskju kardijaċi.
English: (plasma FVIII concentration<1%) with either the use of pdFVIII or rFVIII concentrates.
Maltese: FVIII derivat mill-plażma (pdFVIII) u rikombinanti (rFVIII).
English: Iblias 250 Iblias 500 Iblias 1000 Iblias 2000 Iblias 3000
Maltese: IU EU/1/15/1077/005- Iblias 3000 IU
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL [for reconstitution of strengths 250/500/1000 IU] 5 mL [for reconstitution of strengths 2000/3000 IU]
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI 2.5 mL [għar-rikostituzzjoni tal-qawwiet 250/500/1,000 IU] 5 mL [għar-rikostituzzjoni tal-qawwiet 2,000/3,000 IU]
English: 1 vial with 5 mL water for injections.
Maltese: Kunjett wieħed b'5 mL ilma għall-injezzjonijiet.
English: Rarely, inhibitors may develop after the first 100 exposure days.
Maltese: Rarement, wieħed jista' jiżviluppa inibituri wara l-ewwel 100 ġurnata ta' esponiment.
English: Detailed instructions for reconstitution and administration of Iblias using the Mix2Vial adapter:
Maltese: Istruzzjonijiet dettaljati għar-rikostituzzjoni u l-għoti ta' Iblias permezz tal-adattatur talMix2Vial:
English: Each package of Iblias contains:
Maltese: Kull pakkett ta' Iblias fih:
English: • allergic reactions including severe sudden allergic reaction
Maltese: • reazzjonijiet allergiċi li jinkludu reazzjoni allerġika severa għal għarrieda
English: Pyrexia, chest discomfort, injection site reactions **
Maltese: Deni, skonfort fis-sider, reazzjonijiet fis-sit talinjezzjoni **
English: 3000 IU (octocog alfa) (600 IU/mL after reconstitution).
Maltese: 3,000 IU (octocog alfa) (600 IU/mL wara r-rikostituzzjoni).
English: ≥ 18 years N=109
Maltese: * Parametru tal-PK ≥ 18-il sena N=109
English: Minor surgery including tooth extraction
Maltese: Kirurġija minuri inkluż qlugħ ta' snien
English: Study 1 Study 2 2 x/week dosing
Maltese: Dożaġġ ta' 2 x/ġimg ħa
English: In an international study involving 41 clinical laboratories, the performance of Iblias in FVIII:C assays was evaluated and compared to a marketed full length rFVIII product.
Maltese: Fi studju internazzjonali li kien jinvolvi 41 laboratorju kliniku, il-prestazzjoni ta' Iblias f'assaġġi FVIII:C ġiet evalwata u mqabbla ma' prodott rFVIII b'tul sħiħ li kien imqiegħed fis-suq.
English: Iblias powder should only be reconstituted with the supplied solvent (2.5 mL or 5 mL water for injections) using the supplied sterile vial filter transfer device.
Maltese: It-trab ta' Iblias għandu jiġi rrikostitwit biss bis-solvent ipprovdut (2,5 mL jew 5 mL ilma għallinjezzjonijiet) bl-użu tat-tagħmir tal-filtru tal-kunjett sterili fornut.
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 kienu kkurati qabel b'Fattur VIII (aktar minn 150 jum ta' kura), antikorpi inibituri (ara sezzjoni 2) jistgħu jiffurmaw b'mod mhux komuni (inqas minn pazjent 1 minn kull 100).
English: Iblias is used for treatment and prevention of bleeding in adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Maltese: Iblias huwa intiż għal kura u l-prevenzjoni ta' fsada f'adulti, adolexxenti u tfal ta' kull età li għandhom l-emofilja A (nuqqas konġenitali tal-fattur VIII).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Iblias is a medicine that contains the active substance human recombinant coagulation factor VIII, also called octocog alfa.
Maltese: Iblias hu mediċina li fiha is-sustanza attiva fattur VIII tal-koagulazzjoni humana rikombinanti, imsejħa wkoll octagon alpha.
English: • the severity of your haemophilia
Maltese: • is-severità tal-emofilja
English: How to use Iblias
Maltese: Tużax Iblias
English: Iblias should be reconstituted and administered with the components (vial adapter, vial with water for injections, disposable syringe, venipuncture set) provided with each package.
Maltese: Iblias għandu jiġi rikostitwit u mogħti permezz tal-komponenti (adapter tal-kunjett, kunjett bl-ilma għall-injezzjonijiet, siringa li tintrema wara li tintuża, sett għat-titqib tal-vina) ipprovduti ma' kull pakkett.
English: In completed clinical studies with 71 paediatric previously treated patients, the frequency, type and severity of adverse reactions in children were found to be similar to those in adults.
Maltese: Fi studji kliniċi li tlestew b'71 pazjent pedjatriku li ġew ikkurati fil-passat, instab li l-frekwenza, it-tip u s-severità tar-reazzjonijiet avversi fit-tfal kienu simili għal dawk fl-adulti.
English: Warm both unopened vials in your hands to a comfortable temperature (do not exceed 37 °C).
Maltese: Saħħan iż-żewġ kunjetti mhux miftuħin f'idejk sakemm jilħqu temperatura komda (taqbiżx 37°C).
English: CSL Behring S.p.A. Tel: +39-02-34964200
Maltese: Tel: +39-02-34964200
English: The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions.
Maltese: Il-kumpless tal-fattur VIII/fattur von Willebrand (vWF) huwa magħmul minn żewġ molekuli (fattur VIII u vWF) li għandhom funzjonijiet fiżjoloġiċi differenti.
English: The known risk factors for inhibitor development can be grouped into patient and treatment-related factors:
Maltese: Natural history and clinical characteristics of inhibitors in previously treated haemophilia A patients: a case series.
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients **includes injection site extravasation, hematoma, infusion site pain, pruritus, swelling *** rash, rash erythematous, rash pruritic
Maltese: PTPs = pazjenti kkurati qabel ** jinkludi ħruġ ta' fluwidu mis-sit tal-injezzjoni, ematoma, uġigħ fis-sit tal-infużjoni, ħakk, nefħa *** raxx, raxx eritematuż, raxx pruritiku
English: May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the label.
Maltese: Jista' jinħażen f'temperaturi sa 25°C għal sa 12-il xahar sad-data ta' skadenza indikata fuq it-tikketta.
English: 1 vial: 3000 IU octocog alfa (600 IU/mL after reconstitution).
Maltese: 3,000 IU octocog alfa (600 IU/mL wara r-rikostituzzjoni).
English: One device pack containing: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 mL syringe - 2 alcohol swabs for single use
Maltese: [Mix2Vial] - 1 sett biex ittaqab il-vina - 1 siringa ta' 5 mL li tintrema wara li tintuża - 2 biċċiet bl-alkoħol li jintużaw darba biss
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 assay.
Maltese: IgG, li jaġixxu kontra l-attività pro-koagulanti ta' fattur VIII, u jiġu mkejla f'Unitajiet Bethesda (BU) għal kull mL ta' plażma bl-użu tal-analiżi modifikata.
English: This trial, known as the SIPPET study (“Survey of Inhibitors in Plasma-Product Exposed Toddlers”) was conducted to evaluate the relative risk of inhibitors in patients treated with pdFVIII compared to rFVIII.
Maltese: Journal of Medicine telqu jimxu Esposti għal Prodotti tal-Plażma, Survey of Inhibitors in Plasma-Product Exposed Toddlers”) saret biex tevalwa r-riskju relattiv tal-inibituri f'pazjenti kkurati b'pdFVIII meta mqabbel ma' rFVIII.
English: Like the UKHCDO study, the FranceCoag study also found no statistically significant increased risk for any rFVIII products vs Advate when French patients (also in the RODIN/Pednet study) were excluded.
Maltese: Bħall-istudju UKHCDO, l-istudju FranceCoag ukoll ma sab l-ebda riskju miżjud statistikament sinifikanti għal xi prodotti rFVIII vs Advate meta pazjenti Franċiżi (fl-istudju RODIN/Pednet ukoll) ġew esklużi.
English: Urticaria uncommon
Maltese: Limfadenopatija komuni
English: Study 2 3 x/week dosing
Maltese: Dożaġġ ta' 3 x/ġimg ħa
English: Iblias can be used in children of all ages.
Maltese: Iblias jista' jintuża fi tfal ta' kull età.
English: BW: Body weight *Success rate defined as % of bleeds treated successfully with =/< 2 infusions
Maltese: BW: Piż tal-ġisem * Ir-rata ta' suċċess definit bħala % tal-ħruġ ta' demm ikkurat b'suċċess b'=/< 2 infużjonijiet
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Ma ġew irrappurtati l-ebda interazzjonijiet ta' prodotti li fihom fattur VIII ta' koagulazzjoni umana (rDNA) ma' prodotti mediċinali oħrajn.
English: Repeated PK measurements after 6 to 12 months of prophylaxis treatment with Iblias did not indicate any relevant changes in PK characteristics after long-term treatment.
Maltese: Kejl ripetut tal-PK wara minn 6 sa 12-il xahar ta' kura ta' profilassi b'Iblias ma indika l-ebda tibdil rilevanti fil-karatteristiċi PK wara kura fit-tul.
English: The potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Maltese: Il-qawwa (IU) hija stabbilita permezz ta' assaġġ kromoġeniku tal-Farmakopea Ewropea.
English: Hypersensitivity uncommon
Maltese: Sensittività eċċessiva mhux komuni
English: OTHER
Maltese: Inibituri
English: The FVIII:C of Iblias can be measured in plasma with a one-stage coagulation assay as well as with a chromogenic assay using the routine methods of the laboratory.
Maltese: L-FVIII:C ta' Iblias jista' jitkejjel fil-plażma b'assaġġ tal-koagulazzjoni ta' stadju wieħed kif ukoll b'assaġġ kromoġeniku permezz tal-metodi ta' rutina tallaboratorju.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% to 2.5% of normal activity.
Maltese: Il-kalkulazzjoni tad-doża meħtieġa ta' fattur VIII hija bbażata fuq sejbiet empiriċi li Unità Internazzjonali (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% ta' attività normali.
English: • One mL Iblias 3000 IU contains approximately 600 IU (3000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Maltese: IU (3,000 IU / 5 mL) ta' fattur VIII tal-koagulazzjoni umana rikombinanti (INN: octocog alfa) wara r-rikostituzzjoni b'ilma għall-injezzjonijiet.
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Maltese: Armi l-kunjett tas-solvent bl-adattatur il-blu talMix2Vial imwaħħal.
English: Two multi-center, open-label, cross-over, uncontrolled, randomized studies in previously treated adults/adolescents with severe haemophilia A (< 1%) and one multicenter, open label, uncontrolled study in previously treated children < 12 years with severe haemophilia A were conducted.
Maltese: Żewġ studji multiċentriċi, open-label, cross-over, mhux ikkontrollati, li fihom il-parteċipanti ntgħażlu b'mod każwali, li saru f'adulti/adolexxenti emofilja A severa (< 1%) li ġew ikkurati fil-passat qabel, u studju wieħed multiċentriku, open label, mhux ikkontrollat, li twettaq fi tfal li ġew ikkurati fil-passat, li kellhom < 12-il sena, b'emofilja A severa.
English: There was no relevant change over the 6-12 months treatment period.
Maltese: Ma kien hemm ebda bidla rilevanti matul ilperjodu ta' kura ta' 6-12-il xahar.
English: Iblias 250 IU powder for solution for injection Iblias 500 IU powder for solution for injection Iblias 1000 IU powder for solution for injection Iblias 2000 IU powder for solution for injection Iblias 3000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Maltese: IU trab għal soluzzjoni għall-injezzjoni Iblias 3000 IU trab għal soluzzjoni għall-injezzjoni fattur VIII rikombinanti uman tal-koagulazzjoni (octocog alfa) Użu għal ġol-vini.
English: After reconstitution this medicinal product contains 0.156 mmol sodium per vial of reconstituted solution (corresponding to 3.59 mg per vial).
Maltese: Wara r-rikostituzzjoni, dan il-prodott mediċinali ikun fih 0.156 mmol ta' sodium f'kull kunjett ta' soluzzjoni rikostitwita (li jikkorrispondi għal 3.59 mg f'kull kunjett).
English: Treatment with both pdFVIII and rFVIII can lead to development of inhibitors (tested with the Nijmegen method of the Bethesda assay and defined as ≥ 0.6 Bethesda units (BU) for “a low titre” inhibitor and >5 BU for a “high-titre” inhibitor).
Maltese: Il-kura b'kemm pdFVIII kif ukoll b'rFVIII tista' twassal għall-iżvilupp tal-inibituri (ittestjat bilmetodu ta' Nijmegen tal-assaġġ Bethesda u definit bħala ≥0.6 unitajiet Bethesda (BU, Bethesda units) għal inibitur ta' “titre baxx” u >5 BU għal inibitur ta' “titre għoli”).