FrancophonIA/ELRC3.0 huggingface dataset:
English: Fertility There are no fertility data available.
Maltese: M'hemmx dejta disponibbli dwar il-fertilità.
English: • The other ingredients are sucrose, L-Histidine, mannitol, polysorbate 20, sodium hydroxide and hydrochloric acid.
Maltese: • Is-sustanzi l-oħra huma sucrose, L-histidine, mannitol, polysorbate 20, sodium hydroxide u hydrochloric acid.
English: Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: Tabella 2 ippreżentata hawn taħt hi skont is-sistema tal-klassifika tal-organi MedDRA (SOC u Livell ta' Terminu Ppreferut).
English: Solvent: 5 mL sodium chloride and water for injections.
Maltese: Solvent: 5 mL sodium chloride u ta' ilma għall-injezzjonijiet
English: ALPROLIX contains sodium
Maltese: ALPROLIX fih is-sodium
English: A total of 35 major surgical procedures were performed and assessed in 22 subjects (21 adults and adolescents, and 1 paediatric patient <12 years of age) in Study I and Study III.
Maltese: Twettqu total ta' 35 proċedura kirurġika maġġuri li ġew evalwati fi 22 individwu (21 adult u adolexxenti, u pazjent pedjatriku wieħed li kellu <12-il sena) fi Studju I u Studju III. Mill-35 operazzjoni maġġuri,
English: Pharmacokinetic parameters1
Maltese: IU/kg) Parametri farmakokinetiċi1
English: The elimination half-life of ALPROLIX (82 hours) is influenced by the Fc region, which in animal models was shown to be mediated by neonatal Fc receptor cycling pathways.
Maltese: Il-half-life ta' eliminazzjoni ta' ALPROLIX (82 siegħa) hija influwenzata mir-reġjun FC, li f'mudelli talannimali intwera li huwa medjat minn pathways ċikliċi tar-riċettur Fc neonatali.
English: Administration (Intravenous Injection):
Maltese: Għoti (Injezzjoni ġol-Vini):
English: H) 1 Gauze pad
Maltese: H) Pad tal-garża waħda
English: The median time on Study II+III was 2.88 years and median number of exposure days was 166.
Maltese: Iż-żmien medjan fuq Studju II+III kien ta' 2.88 sena u n-numru medjan ta' jiem ta' esponiment kien ta' 166.
English: Prophylaxis Individualised Regimen:
Maltese: Kors ta' Profilassi Individwalizzat:
English: The median dosing interval overall was 6.99 day (interquartile range, 6.94 to 7.03) with no difference in the median dosing interval between age cohorts.
Maltese: Globalment, l-intervall tad-dożaġġ medjan kien ta' 6.99 jiem (medda interkwartili, 6.94 sa 7.03), mingħajr ebda differenza fil-medjan tal-intervall tad-dożaġġ bejn il- gruppi (cohorts) tal-età.
English: The total number of exposure days was 26,106 with a median of 165 (range 1-528) exposure days persubject.
Maltese: In-numru totali ta' jiem ta' esponiment kien ta' 26,106 b'medjan ta' 165 (medda 1-528) jum ta' esponiment għal kull individwu.
English: Excipient with known effect: 0.3 mmol (6.4 mg) sodium per vial.
Maltese: 0.3 mmol (6.4 mg) ta' sodium f'kull kunjett.
English: ALPROLIX can be used for all age groups.
Maltese: ALPROLIX jista' jintuża għall-gruppi kollha ta' età.
English: Hypersensitivity to the active substance (recombinant human coagulation factor IX, and/or Fc domain) or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva (fattur tal-koagulazzjoni IX uman rikombinanti, u/jew dominju Fc) jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: 1 Pharmacokinetic parameters are presented in Geometric Mean (95% CI) 2 These pharmacokinetic parameters obtained from the compartmental analysis Abbreviations: CI = confidence interval; Cmax= maximum activity; AUC = area under the FIX activity time curve; t1/2 = terminal half-life; t½α = distribution half-life; t½β = elimination half-life; CL = clearance; Vss = volume of distribution at steady-state; MRT = mean residence time.
Maltese: CI = intervall ta' kunfidenza (confidence interval); Cmax = attività massima (maximum activity); AUC = erja taħt ilkurva ħin-attività ta' FIX (area under the FIX activity time curve); t½α = distribuzzjoni tal-half-life (distribution half-life); t½β = half-life tal-eliminazzjoni (elimination half-life); t½ = half-life terminali (terminal half-life); CL = tneħħija (clearance); Vss = volum ta' distribuzzjoni fl-istat fiss (volume of distribution at steady-state);
English: Pharmacokinetic parameters of ALPROLIX were determined for adolescents in study I (pharmacokinetic sampling was conducted pre-dose followed by assessment at multiple time points up to 336 hours (14 days) post-dose) and for children in study II (pharmacokinetic sampling was conducted pre-dose followed by assessment at 7 time points up to 168 hours (7 days) post-dose).
Maltese: Il-parametri farmakokinetiċi ta' ALPROLIX ġew stabbiliti għall-adolexxenti fi studju I (it-teħid ta' kampjuni farmakokinetiċi twettaq qabel id-doża, segwit minn evalwazzjoni f'punti multipli sa 336 siegħa (14-il jum) wara d-doża) u għat-tfal fi studju II (it-teħid ta' kampjuni farmakokinetiċi twettaq qabel iddoża, segwit minn evalwazzjoni f'7 punti ta' ħin sa 168 siegħa (7 ijiem) wara d-doża).
English: Other medicines and ALPROLIX
Maltese: Mediċini oħra u ALPROLIX
English: The specific activity of ALPROLIX is 55-84 IU/mg protein.
Maltese: L-attività speċifika ta' ALPROLIX hi ta' 55-84
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 li fihom fattur IX b'purità baxxa ġie assoċjat ma' episodji ta' infart mijokardijaku, koagulazzjoni intravaskulari mifruxa (disseminated intravascular coagulation), trombożi venuża u emboliżmu pulmonari.
English: L-histidine
Maltese: L-Iżvezja
English: There was a lower proportion of subjects in individualised interval prophylaxis with ≥1 target joint at baseline than in weekly prophylaxis (27.6% and 57.1%, respectively).
Maltese: Kien hemm proporzjon aktar baxx ta' individwi fi profilassi b'intervall individwalizzat b'mira magħquda ta' ≥1 fillinja bażi milli fi profilassi ta' kull ġimgħa (27.6% u 57.1%, rispettivament).
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: No bleeding episodes were experienced in 33% of paediatric subjects.
Maltese: Ma kien hemm l-ebda episodju ta' ħruġ ta' demm fi 33% tal-individwi pedjatriċi.
English: The safety, efficacy, and pharmacokinetics of ALPROLIX were evaluated in 2 multinational, open-label, pivotal studies; a phase 3 study in adults and adolescents, referred to as study I and a phase 3 paediatric study, referred to as study II (see Paediatric population).
Maltese: multinazzjonali u open-label; studju ta' fażi 3 f'adulti u adolexxenti, magħruf bħala studju I, u studju pedjatriku ta' fażi 3, magħruf bħala studju II (ara Popolazzjoni pedjatrika).
English: The median average dose per injection to maintain hemostasis during surgery was 94.7 IU/kg (range: 49 to 152 IU/kg).
Maltese: IU/kg (medda: 49 sa 152 IU/kg).
English: The estimate of CL of ALPROLIX for a typical 70 kg adult is 2.30 dL/h and steady-state volume of distribution of ALPROLIX is 194.8 dL, respectively.
Maltese: L-istima ta' CL (tneħħija) ta' ALPROLIX għal adult tipiku ta' 70 kg kienet ta' 2.30 dL/siegħa u l-volum ta' distribuzzjoni fl-istat fiss ta' ALPROLIX kien ta' 194.8 dL, rispettivament.
English: The total dose on the day of surgery ranged from 49 to 341 IU/kg and the total dose in the 14 day perioperative period ranged from 60 to 1947 IU/kg.
Maltese: Id-doża totali fil-jum tal-operazzjoni varjat minn 49 sa 341 IU/kg u d-doża totali fil-perjodu perioperattiv ta' 14-il jum varjat minn 60 sa 1947
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta' min jinnota li l-ABR mhuwiex komparabbli bejn konċentrati ta'fattur differenti u bejn studji kliniċi differenti.
English: ALPROLIX can be used in children and adolescents of all ages.
Maltese: ALPROLIX jista' jintuża fi tfal u adolexxenti ta' kull età.
English: A population pharmacokinetic model was developed based on FIX activity data from 161 subjects of all ages (2-76 years of age) weighing between 12.5 kg to 186.7 kg in three clinical studies (12 subjects in a phase 1/2a study, 123 subjects in study I and 26 subjects in study II).
Maltese: Mudell farmakokinetiku tal-popolazzjoni ġie żviluppat abbażi tad-dejta ta' attività FIX minn 161 individwu ta' kull età (minn sentejn sa 76 sena) li kienu jiżnu bejn 12.5 kg u 186.7 kg fit-tliet studji kliniċi (12-il individwu fi studju ta' fażi 1/2a studju, 123 individwu fi studju I u 26 individwu fi studju II).
English: B) 5 mL Solvent in pre-filled syringe C) 1 Plunger rod
Maltese: B) 5 mL ta' Solvent f'siringa mimlija għal lest
English: MRT (h)
Maltese: NUMRU(I)
English: The median average weekly dose of ALPROLIX was 59.40 IU/kg (interquartile range, 52.95 to 64.78 IU/kg) for subjects <6 years of age and 57.78 IU/kg (interquartile range, 51.67 to 65.01 IU/kg) for subjects 6 to <12 years of age.
Maltese: Il-medjan tad-doża medja fil-ġimgħa ta' ALPROLIX kien ta' 59.40 IU/kg u (medda interkwartili, 52.95 sa 64.78 IU/kg) għal individwi li kellhom <6 snin, u 57.78 IU/kg (medda interkwartili, 51.67 sa
English: Remove the plastic flip-top cap from the ALPROLIX vial
Maltese: Neħħi l-għatu flip-off tal plastik mill-kunjett ta' ALPROLIX.
English: Elderly population There is limited experience in patients ≥ 65 years.
Maltese: Hemm esperjenza limitata f'pazjenti li jkollhom ≥65 sena.
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Maltese: Mekkaniżmu ta' azzjoni Fattur IX hu glikoproteina b'katina waħda, b'piż molekulari ta' madwar 68,000 Dalton.
English: If you are on a controlled sodium diet, see section 2.
Maltese: Jekk qiegħed fuq dieta kkontrollata tas-sodium, ara sezzjoni 2.
English: ALPROLIX pack contains:
Maltese: Tużax ALPROLIX:
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: Sindrome nefrotika ġiet irrappurtata wara tentattiv ta' induzzjoni ta' tolleranza immuni f'pazjenti b'emofilja B b'inibituri ta' fattur IX u bi storja medika ta' reazzjonijiet allerġiċi.
English: t½α (h)2 t½β (h)2
Maltese: It-tabib tiegħek se jiddeċiedi d-doża tiegħek ta' ALPROLIX (f'Unitajiet
English: Treatment of bleeding: Of the 636 bleeding events observed during study I, 90.4 % were controlled with 1 injection and overall 97.3% with 2 or fewer injections.
Maltese: Mis-636 avveniment ta' ħruġ ta' demm osservati matul sudju I, 90.4% ġew ikkontrollati b'injezzjoni waħda, u globalment, 97.3% b'żewġ injezzjonijiet jew anqas.
English: For subjects in the individualised interval arm, the median dosing interval was 12.53 days (IQR: 10.4-13.4) in Study I. The corresponding median ABR was 1.38 (IQR: 0.00-3.43) and remained similar throughout Study III (1.85 (IQR: 0.76-4.0)).
Maltese: Il-medjan tal-ABR korrispondenti kien ta' 1.38 (IQR: 0.00-3.43) u baqa' simili matul Studju III (1.85 (IQR: 0.76-4.0)).
English: The study enrolled a total of 123 previously treated male patients (12 to 71 years of age) with severe haemophilia B (≤2% endogenous FIX activity).
Maltese: L-istudju rreġistra total ta' 123 pazjent raġel li ġew ikkurati fil-passat (minn 12 sa 71 sena) b'emofilja B severa (≤2% ta' attività FIX endoġena).
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX, ATC code: B02BD04
Maltese: Kategorija farmakoterapewtika: mediċini kontra l-emorraġiji; fattur IX tal-koagulazzjoni tad-demm,
English: The prepared product should be injected intravenously over several minutes.
Maltese: ALPROLIX għandu jiġi injettat ġol-vina fuq perjodu ta' diversi minuti.
English: 1PK parameters derived from noncompartmental analysis are presented in Geometric Mean (95% CI) Abbreviations: CI = confidence interval; IR = incremental recovery; AUC = area under the FIX activity time curve; t1/2 = terminal half-life; MRT = mean residence time; CL = clearance; Vss = volume of distribution at steady-state
Maltese: CI = intervall ta' kunfidenza (confidence interval); IR = irkupru inkrementali (incremental recovery); AUC = erja taħt il-kurva ħin-attività ta' FIX (area under the FIX activity time curve); t½ = half-life terminali (terminal half-life);
English: Prophylaxis fixed weekly and individualised intervals:
Maltese: Profilassi fissa darba fil-ġimgħa u intervall individwalizzat:
English: Pharmacokinetic samples were collected pre-dose and then subsequently at 11 time points up to 240 hours (10 days) post-dose.
Maltese: Il-kampjuni farmakokinetiċi nġabru qabel id-doża u mbagħad sussegwentement fi11-il punt ta' ħin sa 240 siegħa (10 ijiem) wara d-doża.
English: CL (mL/h/kg) t½ (h)
Maltese: CL (mL/siegħa/kg) t½ (sigħat) t½α (sigħat)2 t½β (sigħat)2 MRT (sigħat)
English: Frequency, type and severity of adverse reactions in children are expected to be similar as in adults.
Maltese: Il-frekwenza, it-tip u s-severità ta' reazzjonijiet avversi fit-tfal huma mistennija li jkunu simili għal dawk fl-adulti.
English: 1 In some patients and circumstances the dosing interval can be prolonged up to 48 hours (see section 5.2 for pharmacokinetic data).
Maltese: 1 F'xi pazjenti u ċirkustanzi, l-intervall tad-dożaġġ jista' jiġi mtawwal għal sa 48 siegħa (ara sezzjoni 5.2 għal dejta farmakokinetika).
English: Because of the potential risk of thrombotic complications with factor IX products, 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 newborn infants, or to patients at risk of thrombotic phenomena or disseminated intravascular coagulation (DIC).
Maltese: Minħabba r-riskju potenzjali ta' kumplikazzjonijiet trombotiċi bi prodotti ta' fattur IX, għandha tinbeda sorveljanza klinika għal sinjali bikrin ta' koagulopatija trombotika u konsumattiva b'testijiet bijoloġiċi adatti meta dan il-prodott jingħata lil pazjenti b'mard tal-fwied, lil pazjenti wara li jkunu għamlu xi operazzjoni, lil trabi tat-twelid, jew lil pazjenti li qegħdin f'riskju ta' fenomeni trombotiċi jew koagulazzjoni intravaskulari mifruxa (disseminated intravascular coagulation, (DIC)).
English: • There is a small chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ALPROLIX.
Maltese: • Hemm ċans żgħir li jista' jkollok reazzjoni anafilattika (reazzjoni allerġika severa, li tiġi f'daqqa) għal ALPROLIX.
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Maltese: Thrombin imbagħad jibdel fibrinogen għal fibrin, u b'hekk jifforma embolu.
English: Study I
Maltese: Studju I
English: Out of 123 subjects who completed Study I, 93 were enrolled in Study III (extension study) with median total follow-up time of 6.5 years.
Maltese: Minn 123 individwu li temmew Studju I, 93 ġew irreġistrati fi Studju III (studju ta' estensjoni) bi żmien totali medjan ta' segwitu ta' 6.5 snin.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodiumfree”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment “ħieles mis-sodium”.
English: The frequencies in the table below were observed in a total of 153 patients with severe haemophilia B in phase III clinical studies and an extension study.
Maltese: Il-frekwenzi fit-tabella hawn taħt ġew osservati f'total ta' 153 pazjent b'emofilja B severa fi studji kliniċi ta' fażi
English: In post-marketing experience, FIX inhibitor development and hypersensitivity (including anaphylaxis) have been observed.
Maltese: Fl-esperjenza ta' wara t-tqegħid fis-suq, kienu osservati żvilupp ta' inibitur ta' FIX u sensittività eċċessiva (inkluża anafilassi).
English: IR (IU/dL per IU/kg) AUC/Dose (IU*h/dL per IU/kg)
Maltese: AUC/Doża (IU*siegħa/dL kull IU/kg)
English: Median weekly dose for subjects in the fixed weekly arm was 45.17 IU/kg (interquartile range (IQR) 38.153.7) in Study I. The corresponding median Annualised Bleeding Rates (ABR) in subjects evaluable for efficacy were 2.95 (IQR: 1.01-4.35) and remained similar throughout Study III (1.85 (IQR: 0.76-4.0)).
Maltese: Ir-Rati Medjani Annwalizzati ta' Ħruġ ta' Demm (ABR, Annualised Bleeding Rates) korrispondenti f'individwi li setgħu jiġu evalwati għall-effikaċja kienu ta' 2.95 (IQR: 1.01-4.35) u baqgħu simili matul Studju III (1.85 (IQR: 0.76-4.0))
English: Sodium chloride Water for injections
Maltese: sodium chloride ilma għall-injezzjonijiet
English: Obstructive uropathy Haematuria Renal colic
Maltese: Eftrenonacog alfa (fattur tal-koagulazzjoni
English: Repeat injection every 24 to 48 hours until pain and acute disability are resolved.
Maltese: Irrepeti l-injezzjoni kull 24 sa 48 siegħa sakemm l-uġigħ u d-diżabilità akuta jkunu għaddew.
English: Out of 30 patients having completed Study II, 27 enrolled to Study III (extension study).
Maltese: Minn 30 pazjent li temmew Studju II, 27 irreġistraw fi Studju III (studju ta' estensjoni).
English: The median overall dose to treat a bleeding episode was 51.47 IU/kg (IQR: 35.21-61.73) in the weekly prophylaxis arm, 49.62 IU/kg (IQR: 35.71-94.82) in the individualised interval prophylaxis arm and 46.58 IU/kg (IQR: 33.
Maltese: Id-doża globali medjana għall-kura ta' episodju ta' ħruġ ta' demm kienet ta' 51.47 IU/kg (IQR: 35.21-61.73) fil-parti tal-istudju dwar profilassi ta' kull ġimgħa, 49.62
English: Solvent: sodium chloride, water for injections
Maltese: Solvent: sodium chloride ilma għall-injezzjonijiet
English: Study II enrolled a total of 30 previously treated male paediatric patients with severe hemophilia B (≤2% endogenous FIX activity).
Maltese: Studju II irreġistra total ta' 30 pazjent tfal subien li ġew ikkurati fil-passat, b'emofilija B severa (≤2% ta'
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Maltese: Kura u l-profilassi ta' ħruġ ta' demm f'pazjenti b'emofilija B (defiċjenza konġenitali ta' fattur IX).
English: ALPROLIX 500 IU powder and solvent for solution for injection ALPROLIX 1000 IU powder and solvent for solution for injection ALPROLIX 2000 IU powder and solvent for solution for injection ALPROLIX 3000 IU powder and solvent for solution for injection eftrenonacog alfa recombinant coagulation factor IX, Fc fusion protein This medicine is subject to additional monitoring.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni ALPROLIX 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni eftrenonacog alfa fattur tal-koagulazzjoni IX rikombinanti , proteina tal-fużjoni Fc,
English: ALPROLIX (eftrenonacog alfa) is a long-acting, fully recombinant, fusion protein comprising human coagulation factor IX covalently linked to the Fc domain of human immunoglobulin G1, and produced by recombinant DNA technology.
Maltese: ALPROLIX (eftrenonacog alfa) hu proteina tal-fużjoni totalment rikombinanti li taġixxi fit-tul, li tinkludi fattur tal-koagulazzjoni IX uman rikombinanti, marbut b'mod kovalenti mad-dominju Fc ta' immunoglobulina umana
English: Patients were less than 12 years of age (15 were <6 years of age and 15 were 6 to <12 years of age).
Maltese: Pazjenti kellhom inqas minn 12-il sena (15 kellhom <6 snin u 15 kellhom minn 6
English: This medicine contains less than 1 mmol sodium (23 mg) per vial after preparation, that is to say essentially “sodium free”..
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kunjett wara l-preparazzjoni, jiġifieri essenzjalment “ħielsa mis-sodium”.
English: Treatment of bleeding episodes: Of the 60 bleeding events observed during study II, 75% were controlled with 1 injection, and overall 91.7% of bleeding episodes were controlled with 2 or fewer injections.
Maltese: Mis-60 avveniment ta' ħruġ ta' demm osservati matul studju II, 75% ġew ikkontrollati b'injezzjoni waħda, u b'mod ġenerali, 91.7% tal-episodji ta' ħruġ ta' demm ġew ikkontrollati b' żewg injezzjonijiet jew inqas.
English: • 100 IU/kg once every 10 days, adjust interval based on individual response.
Maltese: • 100 IU/kg darba kull 10 ijiem, aġġusta l-intervall skont ir-rispons individwali.
English: Repeat injection every 8 to 24 hours as necessary until adequate wound healing, then therapy at least for another 7 days to maintain a factor IX activity of 30% to 60% (IU/dL).
Maltese: Irrepeti l-injezzjoni kull 8 sa 24 siegħa skont il-ħtieġa sakemm jinkiseb fejqan adegwat tal ferita, imbagħad kompli t-terapija għal mill inqas 7 ijiem biex iżżomm l-attività ta' fattur IX ta' 30% sa 60% (IU/dL).
English: Powder: lyophilised, white to off-white powder or cake.
Maltese: Trab: trab jew kejk lyophilised, minn abjad sa offwhite.
English: Pharmacokinetic properties were evaluated in 22 subjects (≥19 years) receiving ALPROLIX (rFIXFc).
Maltese: Il-propjetatiet farmakokinetiċi ġew evalwati fi 22 individwu (≥ 19-il sena) li kienu qed jirċievu
English: ALPROLIX 250 IU powder for injection ALPROLIX 500 IU powder for injection ALPROLIX 1000 IU powder for injection ALPROLIX 2000 IU powder for injection ALPROLIX 3000 IU powder for injection eftrenonacog alfa recombinant coagulation factor IX IV
Maltese: IU trab għall-injezzjoni ALPROLIX 1000 IU trab għall-injezzjoni ALPROLIX 2000
English: Polysorbate 20
Maltese: ALPROLIX 250
English: ALPROLIX 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU eftrenonacog alfa.
Maltese: Kull kunjett nominalment fih 3000 IU ta' eftrenonacog alfa.
English: Table 4: The Observed Mean (SD) FIX activity [IU/dL] following a single dose of ALPROLIX1 for patients
Maltese: Tabella 4: Il-Medja Osservata tal--attività ta' FIX [IU/dL] wara doża waħda ta' ALPROLIX1 għal pazjenti ≥12-il sena
English: Each pack of ALPROLIX contains 1 powder vial, 5 mL solvent in pre-filled syringe, 1plunger rod, 1vial adapter, 1 infusion set, 2 alcohol swabs, 2 plasters and 1 gauze pad
Maltese: Kull pakkett ta' ALPROLIX fih kunjett wieħed bit-trab, 5 mL ta' solvent f'siringa mimlija għal-lest, lasta tal-planġer waħda, adapter tal-kunjett wieħed, sett tal-infużjoni wieħed, 2 biċċiet bl-alkoħol, 2 stikek, pad tal-garża waħda.
English: The median overall dose to treat a bleeding episode was 68.22 IU/kg (interquartile range,
Maltese: Il-medjan taddoża totali biex jiġi kkurat episodju ta' ħruġ ta' demm kien ta' 68.22 IU/kg (medda interkwartili,
English: Allergic type hypersensitivity reactions have been reported with ALPROLIX.
Maltese: Reazzjonijiet ta' sensittività eċċessiva tat-tip allerġiku ġew irrappurtati b'ALPROLIX.
English: Content: 1 powder vial, 5 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 plasters, 1 gauze
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: kunjett wieħed bit-trab, 5 mL ta' solvent f'siringa mimlija għal-lest, lasta tal-planġer waħda, adapter tal-kunjett wieħed, sett tal-infużjoni wieħed, 2 biċċiet bl-alkoħol, 2 stikek, garża waħda
English: Minor surgery including tooth extraction
Maltese: Operazzjoni minuri li tinkludi estrazzjoni ta' sinna
English: For extent and age characterisation of the safety database in children see section 5.1.
Maltese: Għall-grad u l-karatterizzazzjoni tal-età tad-database tas-sigurtà fit-tfal, ara sezzjoni 5.1
English: ALPROLIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU eftrenonacog alfa.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni ALPROLIX 2000
English: Adverse reactions
Maltese: MedDRA Reazzjonijiet avversi
English: Dosing intervals and factor consumption remained similar in Study III compared to Study II.
Maltese: L-intervalli tad-dożaġġ u l-konsum tal-fattur baqgħu simili fi Studju III meta mqabbla ma' Studju II.