FrancophonIA/ELRC3.0 huggingface dataset:
English: Xeljanz was more effective than placebo at reducing the symptoms of ulcerative colitis in three main studies.
Maltese: Xeljanz kien aktar effettiv mill-plaċebo biex inaqqas is-sintomi ta' kolite ulċerattiva fi tliet studji ewlenin.
English: Xeljanz is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints, and psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints).
Maltese: Xeljanz huwa mediċina għall-kura ta' adulti b'artrite rewmatika moderata sa severa, marda li tikkawża infjammazzjoni tal-ġogi, u artrite poritika (irqajja' ħomor bil-qoxra fuq il-ġilda b'infjammazzjoni talġogi).
English: The most common side effects with Xeljanz (seen in between 1 and 10 patients in 100) are headache, infection and inflammation of the nose and throat, diarrhoea, nausea (feeling sick), joint pain and hypertension (high blood pressure).
Maltese: L-effetti sekondarji l-aktar komuni b'Xeljanz (li dehru f'madwar 1 u 10 pazjenti minn kull 100) huma wġigħ ta' ras, infezzjoni u infjammazzjoni tal-imnieħer u tal-griżmejn, dijarea, nawsja (tħossok ma tiflaħx), uġigħ fil-ġogi u ipertensjoni (pressjoni tad-demm għolja).
English: In the first study symptoms improved substantially in 50 and 52% respectively of patients taking Xeljanz and adalimumab for 3 months, compared with 33% of those receiving placebo; patients given Xeljanz or adalimumab also showed a greater improvement in their ability to perform everyday activities.
Maltese: Fl-ewwel studju, is-sintomi tjiebu sostanzjalment f'50 u fi 52 % rispettivament tal-pazjenti li ħadu Xeljanz u adalimumab għal 3 xhur, meta mqabbel ma' 33 % ta' dawk li rċevew il-plaċebo; pazjenti li ngħataw Xeljanz jew adalimumab urew ukoll titjib akbar fil-ħila tagħhom li jagħmlu attivitajiet ta' kuljum.
English: For the treatment of ulcerative colitis, the recommended dose is 10 mg twice a day for the first 8 weeks and then 5 mg twice a day.
Maltese: Għall-kura ta' kolite ulċerattiva, id-doża rakkomandata hija 10 mg darbtejn kuljum għall-ewwel 8 ġimgħat imbagħad 5 mg darbtejn kuljum.
English: Xeljanz, in combination with methotrexate, was shown to be effective at improving symptoms of psoriatic arthritis in 3 main studies.
Maltese: Xeljanz, flimkien ma' metotressat, intwera li huwa effettiv fit-titjib tas-sintomi ta' artrite psorjatika fi 3 studji ewlenin.
English: How does Xeljanz work?
Maltese: Kif jintuża Xeljanz?
English: In general, the risks with Xeljanz were similar to those of other medicines of its class.
Maltese: B'mod ġenerali, ir-riskji b'Xeljanz kienu simili għal dawk ta' mediċini oħra tal-klassifika tiegħu.
English: Xeljanz is available as tablet (5 and 10 mg) to be taken by mouth.
Maltese: Xeljanz jiġi bħala pillola (5 u 10 mg) li għandha tittieħed mill-ħalq.
English: For the treatment of rheumatoid arthritis and psoriatic arthritis, the recommended dose is 5 mg taken twice a day.
Maltese: Għall-kura tal-artrite rewmatika u tal-artrite psorjatika, id-doża rakkomandata hija 5 mg li tittieħed darbtejn kuljum.
English: These enzymes play an important role in the process of inflammation that occur in rheumatoid and psoriatic arthritis, and ulcerative colitis.
Maltese: Dawn l-enzimi għandhom rwol importanti fil-proċess ta' infjammazzjoni li jseħħu flartrite rewmatika u psorjatika, u kolite ulċerattiva.
English: Similarly, in a second study with 547 patients, after 8 weeks of treatment 17% of patients treated with Xeljanz had mild or no symptoms compared with 4% of placebo-treated patients.
Maltese: Bl-istess mod, fit-tieni studju b'547 pazjent, wara 8 ġimgħat ta' kura, 17 % tal-pazjenti kkurati b'Xeljanz kellhom sintomi ħfief jew l-ebda sintomu meta mqabbel ma' 4 % tal-pazjenti kkurati bil-plaċebo.
English: Why is Xeljanz authorised in the EU?
Maltese: Għaliex Xeljanz ġie awtorizzat fl-UE?
English: The second study compared Xeljanz with placebo in 395 patients.
Maltese: It-tieni studju qabbel Xeljanz ma' plaċebo fi 395 pazjent.
English: Xeljanz is used together with methotrexate after treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects.
Maltese: Xeljanz jintuża flimkien ma' metotressat meta kura b'mediċina waħda jew aktar magħrufa bħala mediċini antirewmatiċi li jimmodifikaw il-marda (DMARDs) ma tkunx ħadmet tajjeb biżżejjed jew tkun wasslet għal effetti sekondarji inkwetanti.
English: Xeljanz is also used to treat adults with moderate to severe ulcerative colitis, a disease causing inflammation and ulcers in the lining of the gut, after treatment with other medicines has not worked well, has stopped working or has led to troublesome side effects.
Maltese: Xeljanz jintuża wkoll biex jikkura adulti b'kolite ulċerattiva moderata sa severa, marda li tikkawża infjammazzjoni u ulċeri fil-kisja tal-musrana, wara kura b'mediċini oħra ma tkunx ħadmet tajjeb, tkun waqfet taħdem jew tkun wasslet għal effetti sekondarji inkwetanti.
English: Date of first authorisation: 11 May 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 11 ta' Mejju 2016
English: ATC code: B02BD04
Maltese: B02BD04
English: IDELVION (50 (IU/kg)) (N=22)
Maltese: IDELVION (50 (UI/kg)) (N=22)
English: Osmolality:
Maltese: Osmolalità:
English: Immune tolerance induction
Maltese: Induzzjoni ta' tolleranza immuni
English: 50 - 80 (initial level)
Maltese: 50 - 80 (livell inizjali)
English: Elimination t1/2 (h)
Maltese: Eliminazzjoni t1/2 (siegħa)
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA ATTIVA BIJOLOĠIKA U MANIFATTUR(I) RESPONSABBLI
English: Frequency of doses (hours) / Duration of therapy (days)
Maltese: Frekwenza tad-dożi (sigħat) /Tul ta' żmien tat-terapija (jiem)
English: • Allergic reactions (Hypersensitivity)
Maltese: • Reazzjonijiet allerġiċi (Sensittività eċċessiva)
English: IR (IU/dl)/(IU/kg)
Maltese: IR (UI/dl)/(IU/kg)
English: Cmax (IU/dl)
Maltese: Cmax (UI/dl)
English: 1 to <6 years (N=12)
Maltese: 1 sa <6 snin (N=12)
English: Other ingredients: Tri-sodium citrate dihydrate, Polysorbate 80, Mannitol, Sucrose, HCl
Maltese: Sustanzi oħra: Tri-sodium citrate dihydrate, Polysorbate 80, Mannitol, Sucrose, HCl
English: IDELVION contains sodium
Maltese: IDELVION fih sodium
English: Up to 25.8 mg (1.13 mmol) sodium per dose (bodyweight 70 kg).
Maltese: Sa 25.8 mg (1.13 mmol) sodium f'kull doża (piż tal-ġisem 70 kg).
English: Frequencies have been evaluated 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-frekwenzi ġew ivvalutati skont il-konvenzjoni li ġejja: 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 magħrufa (ma tistax tiġi stmata mid-data disponibbli).
English: The active substance is:
Maltese: Is-sutanza attiva hija:
English: The recombinant factor IX portion is identical to the Thr148 allelic form of plasmaderived factor IX.
Maltese: Il-porzjon rikombinanti tal-fattur IX huwa identiku għallforma allelika Thr148 tal-fattur IX miksub mill-plażma.
English: IR = incremental recovery; AUC = area under the factor IX activity time curve; CL = body weight adjusted clearance; Elimination t1/2 = Elimination half-life
Maltese: IR = żieda regolari fl-irkupru (incremental recovery); AUC = erja taħt il-kurva tal-attivita tal-fattur IX u l-ħin; CL = tneħħija aġġustata skont il-piż tal-ġisem; Eliminazzjoni t1/2 = Half life ta' eliminazzjoni
English: What is IDELVION?
Maltese: IDELVION?
English: IDELVION 250 IU
Maltese: IDELVION 250
English: The pharmacokinetics (PK) of IDELVION were evaluated following an intravenous injection of a single dose of 25, 50 and 75 IU/kg.
Maltese: Il-farmakokinetika (PK - pharmacokinetics) ta' IDELVION ġiet ivvalutata wara injezzjoni fil-vini ta' doża waħda ta' 25, 50 u 75 UI/kg.
English: AUC0-inf (h*IU/dl)
Maltese: AUC0-inf (siegħa*UI/dl)
English: The safety and efficacy in the perioperative setting was evaluated in two pivotal Phase 3 studies (Study 3001 and 3002) and the on-going Phase 3 safety extension study (Study 3003).
Maltese: Is-sigurtà u l-effikaċja fl-ambjent ta' qabel u wara operazzjoni ġie vvalutat f'żewġ studji pivitali ta' Fażi 3 (Studju 3001 u 3002) u fl-istudju ta' estensjoni tas-sigurtà ta' Fażi 3 li għadu għaddej (Studju 3003).
English: Of the 106 bleeding episodes, the majority (94; 88.7%) was treated with single injection, 103; 97.2% were treated with 1-2 injections.
Maltese: Mill-106 episodji ta' ħruġ ta' demm, il-maġġoranza (94; 88.7%) ġew ittrattati b'injezzjoni waħda, 103; 97.2% ġew ittrattati b'injezzjoni waħda sa 2.
English: CL (ml/h/kg)
Maltese: CL (ml/siegħa/kg)
English: 12 to <18 years (N=5)
Maltese: 12 sa <18-il sena (N=5)
English: • Dizziness
Maltese: • Ekżema
English: IDELVION 250 IU powder and solvent for solution for injection 175 - 215 mOsm/kg.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni 175 - 215 mOsm/kg.
English: A dose of 2000 IUs of IDELVION, administered to a 80 kg patient, should be expected to result in a peak post-injection factor IX increase of 2000 IUs x 1.3 (IU/dl per IU/kg) /80 kg = 32.5 IU/dl (32.5 % of normal).
Maltese: UI ta' IDELVION, mogħtija lill-pazjent ta' 80 kg, għandha tkun mistennija li wara l-injezzjoni twassal għall-ogħla żieda fil-fattur IX ta' 2000 UI x 1.3 (UI/dl għal kull UI/kg)/80 kg = 32.5 UI/dl (32.5 % tan-normal).
English: • The formation of inhibitors (neutralising antibodies) is a known complication that has been reported during treatment with IDELVION, which stops the treatment from working properly.
Maltese: • Il-formazzjoni ta' inibituri (antikorpi li jinnewtralizzaw) huwa magħruf bħala kumplikazzjoni li ġiet irrappurtata matul it-trattament b'IDELVION, li twaqqaf it-trattament milli jaħdem sewwa.
English: Inhibitors
Maltese: Inhibituri
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għall-preżentazzjoni tar-rapporti perjodiċi aġġornati għal dan il-prodott mediċinali huma stabbiliti fil-lista ta' dati ta 'referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c (7) tadDirettiva 2001/83 / KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il Ewropew mediċini web-portal.
English: The mean factor IX activity at day 7 and day 14 was 13.76% and 6.10%, respectively, after a single dose of 50 IU/kg IDELVION.
Maltese: Il-medja tal-attività tal-fattur IX f'jum 7 u jum 14 kienu 13.76% u 6.10 %, rispettivament, wara doża waħda ta' 50
English: (initial level)
Maltese: (livell inizjali)
English: One pack with 250, 500 or 1000 IU containing: 1 vial with powder
Maltese: Pakkett wieħed ta' 250, 500 jew 1,000 UI li fih:
English: Albutrepenonacog alfa 2000 IU
Maltese: Albutrepenonacog alfa 2000 UI
English: Tri-sodium citrate dihydrate, polysorbate 80, mannitol, sucrose, and HCl (for pH adjustment) See last paragraph of section 2.
Maltese: Tri-sodium citrate dihydrate, polysorbate 80, mannitol, sucrose, u HCl (għall-aġġustament tal-pH) Ara l-aħħar paragrafu ta' sezzjoni 2.
English: Trough levels of 5-10% have been targeted in clinical trials for achieving bleeding control while on prophylaxis.
Maltese: Fi provi kliniċi kienu mmirati livelli baxxi ta' 5-10% biex jinkiseb kontroll tal-ħruġ ta' demm waqt li wieħed ikun fuq profilassi.
English: 6 to <12 years (N=15)
Maltese: 6 snin sa <12-il sena (N=15)
English: IDELVION 2000 IU powder and solvent for solution for injection 260 - 300 mOsm/kg.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni 260 - 300 mOsm/kg.
English: Comparison of Pharmacokinetic Parameters of IDELVION by Age Category (Median (min, max)) Following a Single Injection of 50 IU/kg IDELVION
Maltese: Tqabbil tal-Parametri Farmakokinetiċi ta' IDELVION skont il-Kategorija tal-Età (Medjan (min, max)) Wara Injezzjoni Waħda ta' 50
English: 50 IU/kg.
Maltese: UI/kg.
English: Exp. date
Maltese: Data meta Jis
English: Powder: Tri-sodium citrate dihydrate, Polysorbate 80, Mannitol, Sucrose, HCl (for pH adjustment).
Maltese: Tri-sodium citrate dihydrate, Polysorbate 80, Mannitol, Sucrose, HCL (għall-aġġustament tal-pH).
English: MedDRA Standard System Organ Class Adverse reactions
Maltese: Klassi tas-Sistemi u tal-Organi
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Maltese: B'mod rari ġew osservati reazzjonijiet ta' sensittività eċċessiva jew allerġiċi (li jistgħu jinkludu anġjoedima, ħruq u tingiż fil-post tal-injezzjoni, tkexkix ta' bard, fwawar, urtikarja mifruxa, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, nawsja, nuqqas ta' kwiet, takikardija, tagħfis fis-sider, tingiż, rimettar, tħarħir) li f'xi każijiet jistgħu javvanzaw għal anafilassi severa (inkluż xokk).
English: Pharmacokinetic (PK) parameters of IDELVION were evaluated in adolescents (12 to <18 years of age) and children (1 to <12 years of age) following an intravenous injection of a single dose of
Maltese: Il-parametri farmakokinetiċi (PK) ta' IDELVION ġew ivvalutati f'adolexxenti (età ta' 12 sa <18-il sena) u tfal (età ta' 1 sa <12-il sena) wara injezzjoni fil-vini ta' doża waħda ta' 50
English: Albutrepenonacog alfa 500 IU
Maltese: Albutrepenonacog alfa 500
English: IDELVION 500 IU
Maltese: IDELVION 500
English: There is no information on the effects of factor IX on fertility.
Maltese: Ma hemm l-ebda informazzjoni dwar l-effetti ta' fattur IX fuq il-fertilità.
English: Median Annualised Bleeding Rate (ABR) on 7 day prophylaxis with IDELVION for all bleeds was 0.0 (range 0-6) and on 14 day-prophylaxis it was 1.08 (range 0-9.1).
Maltese: (medda 0-6) u fl-14il jum profilassi dan kien 1.08 (medda 0-9.1).
English: Albumin is a natural, inert carrier protein in plasma with a half-life of approximately 20 days.
Maltese: L-albumina hija proteina naturali, ġarriera, inerti fil-plażma b'half-life ta' madwar 20 jum.
English: IDELVION 1000 IU
Maltese: IDELVION 1000
English: Albutrepenonacog alfa 1000 IU
Maltese: Albutrepenonacog alfa 1000 UI
English: Allergic type hypersensitivity reactions are possible with IDELVION.
Maltese: Huma possibbli reazzjonijiet ta' sensittività eċċessiva tat-tip allerġiku b'IDELVION.
English: Required dose (IU) = body weight (kg) x desired factor IX rise (% of normal or IU/dl) x {reciprocal of observed recovery (IU/kg per IU/dl)}
Maltese: Doża meħtieġa (UI) = piż tal-ġisem (kg) x żieda mixtieqa fil-fattur IX (% tan-normal jew UI/dl) x {reċiproku tal-irkupru osservat (UI/kg għal kull UI/dl)}
English: Factor IX level required (%) (IU/dl)
Maltese: Livell ta' Fattur IX meħtieġ (%) (UI/dl)
English: From those subjects, 8 (38%) experienced at least one bleeding during the 14 day-prophylaxis, while they had no bleeding events during once weekly prophylaxis.
Maltese: Minn dawn issuġġetti, 8 (38%) esperjenzaw mill-inqas fsada waħda matul l-14-il jum ta' profilassi, filwaqt li ma kellhom l-ebda avvenimenti ta' fsada matul il-profilassi ta' darba fil-ġimgħa.
English: Albutrepenonacog alfa 250 IU
Maltese: Albutrepenonacog alfa 250 UI
English: The active substance in IDELVION is albutrepenonacog alfa (recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)).
Maltese: Is-sustanza attiva f'IDELVION hija albutrepenonacog alfa (proteina rikombinanti ta' fużjoni li tagħqqad il-fattur IX ta' koagulazzjoni mal-albumina (rIX-FP)).
English: Genetic fusion of recombinant coagulation factor IX with albumin extends the half-life of factor IX (see section 5.2).
Maltese: Fużjoni ġenetika tal-fattur IX rikombinanti ta' koagulazzjoni mal-albumina ittawwal il-halflife tal-fattur IX (ara sezzjoni 5.2).
English: 1 disposable 10 ml syringe 1 venipuncture set 2 alcohol swabs
Maltese: Siringa 1 ta' 10 ml li tintrema wara li tintuża Sett 1 biex ittaqqab il-vina 2 imselħiet bl-alkoħol
English: IDELVION 2000 IU
Maltese: IDELVION 2000
English: After reconstitution the chemical and physical in-use stability has been demonstrated for 8 hours at 2-25 °C).
Maltese: Wara r-rikostituzzjoni l-istabbilità kimika u fiżika waqt l-użu intweriet għal 8 sigħat f'temperatura ta' 2-25
English: Repeat PK assessment for up to 30 weeks demonstrated a stable pharmacokinetic profile and incremental recovery was consistent over time.
Maltese: Valutazzjoni ripetuta tal-PK sa 30 ġimgħa uriet profil farmakokinetiku stabbli u ż-żieda regolari fl-irkupru kienet konsistenti matul iż-żmien.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: It-tabella ppreżentata taħt qegħda skont il-klassifikazzjoni tas-sistemi u tal-organi MedDRA (SOCsystem organ classification u l-Livell tat-Terminu Ppreferut).
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Maltese: Trombin, imbagħad ibiddel il-fibrinogin f'fibrin u jkun jista' jifforma tagħqid tad-demm.
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Maltese: Minħabba r-riskju possibbli ta' kumplikazzjonijiet trombotiċi, għandha tinbeda sorveljanza klinika għal sintomi bikrin ta' koagulopatija trombotika u li tikkonsma b'ittestjar bijoloġiku xieraq meta wieħed jagħti dan il-prodott lill-pazjenti b'mard tal-fwied, lill-pazjenti wara operazzjonijiet, lit-trabi tat-twelid jew lill-pazjenti li qegħdin f'riskju ta' fenomeni trombotiċi jew DIC.
English: • Allergic-type hypersensitivity reactions are possible and may include the following symptoms: hives, skin rashes (generalised urticaria), tightness of the chest, wheezing, low blood pressure (hypotension) and anaphylaxis (a serious reaction that causes severe difficulty in breathing or dizziness).
Maltese: • Reazzjonijiet ta' sensittività eċċessiva tat-tip allerġiċi huma possibbli u jistgħu jinkludu issintomi li ġejjin: ħorriqija, raxx fil-ġilda (urtikarja mifruxa), tagħfis fis-sider, tħarħir, pressjoni baxxa (ipotensjoni) u anafilassi (reazzjoni serja li tikkawża diffikultà severa bit-teħid tan-nifs jew sturdament).
English: Expected factor IX rise (IU/dl or % of normal) = Dose (IU) x Recovery (IU/dl per IU/kg)/body weight (kg)
Maltese: Żieda mistennija fil-fattur IX (UI/dl jew % tan-normal) = Doża (UI) x Irkupru (UI/dl għal kull UI/kg)/piż tal-ġisem (kg)
English: Bring the solvent to room temperature (below 25 °C).
Maltese: Taħżinx f'temperatura 'l fuq minn 25 °C.
English: CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg Germany
Maltese: CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg IL-ĠERMANJA
English: Hypersensitivity to the active substance (recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)) or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva (proteina rikombinanti ta' fużjoni li tgħaqqad il-fattur IX ta' koagulazzjoni mal-albumina (rIX-FP)) jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Germany
Maltese: CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Il-Ġermanja
English: The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism.
Maltese: L-użu ta' prodotti ta' fattur IX li jkollhom purità baxxa kien assoċjat ma' każijiet partikulari ta' infart mijokardijaku, koagulazzjoni intravaskulari mifruxa, trombożi fil-vini u emboliżmu fil-pulmuni.
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Maltese: Trattament u profilassi għal ħruġ ta' demm f'pazjenti b'emofilja B (defiċjenza konġenitali talfattur IX).
English: CSL Behring GmbH Emil-von-Behring-Str. 76 35041 Marburg Germany
Maltese: CSL Behring GmbH Emil-von-Behring-Str. 76 35041 Marburg Il-Ġermanja
English: IDELVION (INN: albutrepenonacog alfa) is a recombinant coagulation factor IX.
Maltese: IDELVION (INN: albutrepenonacog alfa) huwa fattur IX rikombinanti ta' koagulazzjoni.
English: IDELVION 250 IU powder and solvent for solution for injection Powder (250 IU) in a 6 ml vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Trab (250 IU) f'kunjett ta' 6 ml (ħġieġ tat-tip I), b'tapp (tal-lastku) ċirku (tal-plastik) u għatu (talaluminju).
English: Do not use IDELVION
Maltese: Tużax IDELVION
English: The efficacy of IDELVION has been evaluated in the open-label, uncontrolled part of a phase 2/3 study, in which a total of 63 male, previously treated patients (PTPs) between 12 and 61 years of age received IDELVION either for prophylaxis once every 7-, 10- and/or 14-day intervals and/or for the treatment of bleeding episodes on an on-demand basis.
Maltese: L-effikaċja ta' IDELVION ġiet ivvalutata fil-parti mhux ikkontrollata tal-istudju ta' fażi 2/3, fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża, li fih total ta' 63 pazjent tas-sess maskili ttrattati qabel (PTPs - previously treated patients) bejn l-etajiet ta' 12-il sena u 61 sena rċivew IDELVION jew għall-profilassi f'intervalli ta' darba kull 7 ijiem, 10 ijiem u/jew 14-il jum u/jew għat-trattament ta' episodji ta' ħruġ ta' demm skont il-ħtieġa.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Maltese: Ġie rrappurtat sindrom nefrotiku wara prova ta' induzzjoni ta' tolleranza immuni f'pazjenti b'emofilja B b'inibituri ta' fattur IX u storja ta' reazzjoni allerġika.
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 ikun meħtieġ apparat ta' aċċess dirett għal vina ċentrali (CVAD - central venous access device), għandhom jitqiesu ir-riskji ta' kumplikazzjonjiet marbuta ma' CVAD inkluż infezzjonijiet lokali, batterimja u trombożi fis-sit tal-kateter.
English: For an incremental recovery of 1.3 IU/dl per 1 IU/kg, the dose is calculated as follows: Dose (IU) = body weight (kg) x desired factor IX increase (IU/dl) x 0.77 dl/kg
Maltese: Għal irkupru b'żieda regolari ta' 1.3 UI/dl għal kull 1 UI/kg, id-doża tiġi kkalkulata kif ġej: Doża (UI) = piż tal-ġisem (kg) x żieda mixtieqa fil-fattur IX (UI/dl) x 0.77 dl/kg
English: IDELVION 1000 IU powder and solvent for solution for injection Powder (1000 IU) in a 6 ml vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Trab (1000 IU) f'kunjett ta' 6 ml (ħġieġ tat-tip I), b'tapp (tal-lastku) ċirku (tal-plastik) u għatu (talaluminju).
English: Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanze attiva bijoloġika
English: IDELVION contains up to 25.8 mg (1.13 mmol) sodium per dose (bodyweight 70 kg) if the maximal dose (15 ml = 6000 IU) is applied.
Maltese: 8 mg (1.13 mmol) sodium f'kull doża (piż tal-ġisem 70 kg) jekk tingħata d-doża massima (15 ml = 6000
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, għandu jkun hemm implimentazzjoni tat-trattament mediku standard għal xokk.