FrancophonIA/ELRC3.0 huggingface dataset:
English: Both studies compared the effects of Fuzeon, in combination with ‘optimised background therapy' (a combination of other antiviral medicines chosen for each patient as they had the best chances of reducing the levels of HIV in the blood), compared with optimised background therapy without Fuzeon.
Maltese: Iż-żewġ studji qabblu l-effetti ta' Fuzeon, mogħti flimkien ma' ‘terapija ta' sfond ottimizzata' (kombinazzjoni ta' mediċini antivirali oħra magħżula għal kull pazjent għax kellhom l-ikbar ċans li jnaqqsu l-livelli ta' HIV fid-demm), meta imqabbla ma' terapija ta' sfond ottimizzata mingħajr Fuzeon.
English: The most common side effects with Fuzeon (seen in more than 1 patient in 10) are injection site reactions (pain and inflammation at the site of injection), peripheral neuropathy (damage to the nerves in the extremities causing tingling or numbness in the hands and feet) and weight loss.
Maltese: L-iktar effetti sekondarji komuni b'Fuzeon (li dehru f'iktar minn pazjent wieħed minn kull 10) huma reazzjonijiet fis-sit ta' l-injezzjoni (ugigħ u infjammazzjoni fis-sit ta' l-injezzjoni), newropatija periferali (ħsara lin-nervituri fl-estremitajiet li jikkawża tnemnim fl-idejn u s-saqajn) u telfien fil-piż.
English: How has Fuzeon been studied?
Maltese: Kif ġie studjat Fuzeon?
English: Fuzeon binds to a protein on the surface of HIV.
Maltese: Fuzeon jeħel ma' proteina fuq il-wiċċ ta' l-HIV.
English: Fuzeon does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Fuzeon ma jfejjaqx l-infezzjoni bl-HIV jew lAIDS, iżda jista' jbiegħed il-ħsara lis-sistema immunoloġika u l-iżvilupp ta' infezzjonijiet u mardiet marbutin ma' l-AIDS.
English: What benefit has Fuzeon shown during the studies?
Maltese: X'benefiċċji ta' Fuzeon ħarġu mill-istudji?
English: In clinical studies, injection site reactions have been reported in 98% of patients, mostly occurring within the first week of treatment.
Maltese: Fl-istudji kliniċi kienu rappurtati reazzjonijiet fis-sit ta' l-injezzjoni fi 98% tal-pazjenti, u ħafna minnhom dehru fl-ewwel ġimgħa tat-trattament.
English: In adults, it is given as one 90-mg injection twice a day, injected under the skin of the upper arm, upper thigh or abdomen (tummy).
Maltese: Huwa jispjega kif il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ivvaluta l-istudji mwettqin, biex jissodisfa ir-rakkomandazzjonijiet tagħhom dwar kif tintuża l-mediċina.
English: Pharmaceutical Form Route of Administration Packaging
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: EU-Number
Maltese: Mnejn jingħata
English: 2 vials + 2 vials
Maltese: 2 kunjetti 2 kunjetti
English: 1 vial + 1 vial
Maltese: 1 kunjett 1 kunjett
English: Strength Pharmaceutical Form Route of Administration
Maltese: Għamla farmaċewtika
English: Osmolality: 590 mOsmol/kg.
Maltese: Osmolalità: 590 mOsmol/kg.
English: Prophylaxis in adults/adolescents
Maltese: Profilassi fl-adulti/adolexxenti
English: * PTPs: Previously-treated patients.
Maltese: * PTPs: Pazjenti ttrattati preċedentement.
English: Protective paper
Maltese: Karta protettiva
English: b Calculation based on 67 profiles.
Maltese: b Kalkolu bbażat fuq 67 profil.
English: PK Parameter N=No.
Maltese: Parametru PK N=Nr. ta' pazjenti
English: Novo Nordisk US Bio Production Inc. 9 Technology Drive West Lebanon
Maltese: 9 Technology Drive West Lebanon
English: Pharmacokinetic parameters
Maltese: Parametri farmakokinetiċi
English: (IU*hour/dL) CL (mL/hour/kg) Vss (mL/kg) MRT (hours)
Maltese: (UI*siegħa/dL) CL (mL/siegħa/kg) Vss (mL/kg) MRT (sigħat)
English: • rash.
Maltese: • raxx.
English: Factor VIII level required (%) (IU/dL)a
Maltese: Fattur VIII (%) (UI/dL)a
English: IR (IU/dL) per (IU/kg)a
Maltese: IR (UI/dL) kull UI/kg)a
English: Maximum factor VIII activity (IU/dL)a t1/2 (hours)
Maltese: Attività massima tal-fattur VIII (UI/dL)a t1/2 (sigħat)
English: EU/1/19/1374/001 EU/1/19/1374/002 EU/1/19/1374/003 EU/1/19/1374/004 EU/1/19/1374/005
Maltese: EU/1/19/1374/001 EU/1/19/1374/002 EU/1/19/1374/003 EU/1/19/1374/004
English: Of the 175 adults/adolescents on prophylaxis, 70 (40%) did not have any bleeds.
Maltese: Mill175 adult/adolexxent fuq profilassi, 70 (40%) ma kellhomx fsada.
English: Solvent for Esperoct Sodium chloride 9 mg/mL
Maltese: Sodium chloride 9 mg/mL
English: Anti-PEG antibodies
Maltese: Antikorpi kontra PEG
English: ANNEX II
Maltese: Tabella 3
English: Powder: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid
Maltese: Trab: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid
English: Number of profiles
Maltese: Numru ta' profili
English: • itching (pruritus)
Maltese: • ħakk (prurite)
English: Contents
Maltese: Kontenut
English: Of the total 1,126 bleeds, 86.9% were effectively treated with 1 injection and 96.8% were effectively treated with 1-2 injections of Esperoct.
Maltese: Minn total ta' 1,126 episodju ta' fsada, 86.9% kienu ttrattati effettivament b'injezzjoni waħda u 96.8% kienu ttrattati effettivament b'injezzjoni waħda jew tnejn ta' Esperoct.
English: The mean annual consumption for prophylaxis was 4641 IU/kg.
Maltese: Il-konsum annwali medju ta' profilassi kien ta' 4641 UI/kg.
English: • allergic reactions (hypersensitivity).
Maltese: • reazzjonijiet allerġiċi (sensittività eċċessiva).
English: 0 to below 6 years N=13
Maltese: 0 sa inqas minn 6 snin N=13
English: Each vial of Esperoct contains nominally 500, 1000, 1500, 2000 or 3000 IU turoctocog alfa pegol.
Maltese: Kull kunjett ta' Esperoct nominalment fih 500, 1000, 1500, 2000 jew 3000 UI turoctocog alfa pegol.
English: No difference in the safety profile was observed between previously treated adolescents (12-18 years) and adult patients.
Maltese: Ma kienet osservata l-ebda differenza fil-profil ta' sigurtà bejn pazjenti adolexxenti (12-18-il sena) u adulti ttrattati preċedentement.
English: Esperoct contains sodium
Maltese: Esperoct fih sodium
English: Table 3 Frequency of adverse reactions in clinical trials for PTPs* MedDRA System Organ Class
Maltese: Frekwenza tar-reazzjonijiet avversi fil-provi kliniċi għal PTPs* Sistema tal-Klassifika tal-Organi tal
English: Always use an aseptic technique.
Maltese: Dejjem uża teknika asettika.
English: The mean annual consumption for prophylaxis was 6475 IU/kg.
Maltese: Il-konsum annwali medju ta' profilassi kien ta' 6475 UI/kg.
English: Allergic reactions (hypersensitivity)
Maltese: Reazzjonijiet allerġiċi (sensittività eċċessiva)
English: Development of ‘FVIII inhibitors' (antibodies)
Maltese: Żvilupp ta' “inibituri tal-FVIII” (antikorpi)
English: Each reconstituted vial contains 30.5 mg of sodium (see section 4.4).
Maltese: Kull kunjett rikostitwit fih 30.5 mg ta' sodium (ara sezzjoni 4.4).
English: • sterile alcohol swabs
Maltese: • mselħiet sterili bl-alkoħol
English: Turoctocog alfa pegol is a purified recombinant human factor VIII (rFVIII) product with a 40 kDa polyethylene-glycol (PEG) conjugated to the protein.
Maltese: Turoctocog alfa pegol hu prodott ippurifikat ta' fattur VIII uman rikombinanti (rFVIII) b'40 kDa polyethylene-glycol (PEG) ikkonjugat mal-proteina.
English: Calcium chloride dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Maltese: Calcium chloride dihydrate Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH)
English: 1500 IU
Maltese: UI, 1500
English: • The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide and hydrochloric acid.
Maltese: • Is-sustanzi mhux attivi l-oħra huma L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide u hydrochloric acid.
English: In total, 129 single-dose pharmacokinetic (PK) profiles of Esperoct were evaluated in 86 patients (including 24 paediatric patients of 0 to below 12 years).
Maltese: Bħala total, ġew evalwati 129 profil farmakokinetiku (PK, pharmacokinetic) wara doża waħda ta' Esperoct f'86 pazjent (inkluż 24 pazjent pedjatriku f'età minn 0 sa inqas minn 12-il sena).
English: The specific activity of turoctocog alfa pegol is approximately 9500 IU/mg protein.
Maltese: L-attività speċifika ta' turoctocog alfa pegol hija madwar 9500 UI/mg ta' proteina.
English: Frequency of doses (hours)
Maltese: Frekwenza tad-dożi (sigħat)
English: 6 to below 12 years N=11
Maltese: 6 snin sa inqas minn 12-il sena N=11
English: The active substance turoctocog alfa pegol is a covalent conjugate of the protein turoctocog alfa* with a 40 kDa polyethylene-glycol (PEG).
Maltese: Is-sustanza attiva turoctocog alfa pegol hija konjugat kovalenti tal-proteina turoctocog alfa* b'40 kDa polyethylene-glycol (PEG).
English: 12 to below18 years N=3
Maltese: 12 sa inqas minn 18-il sena N=3
English: 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 stmati 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 magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: 18 years and above N=42
Maltese: 18-il sena u ikbar N=42
English: Abbreviations: AUC = area under the factor VIII activity time profile; t1/2 = terminal half-life; MRT = mean residence time; CL = clearance; Vss = volume of distribution at steady-state; IR = Incremental recovery.
Maltese: AUC = erja taħt il-kurva tal-profil tal-ħin tal-attività tal-fattur VIII; t1/2 = : half-life terminali;
English: The ABR for randomised patients was 1.77 (0.59; 5.32) for treatment every 4 days and 3.57 (2.13; 6.00) for once weekly prophylaxis.
Maltese: L-ABR għall-pazjenti li ntgħażlu b'mod arbitrarju kien ta' 1.77 (0.59; 5.32) għal trattament kull 4 ijiem u 3.57 (2.13; 6.00) għal profilassi darba fil-ġimgħa.
English: Duration of therapy
Maltese: Tul tat-terapija
English: The median annualised bleeding rate (ABR) in adults and adolescents receiving Esperoct was 1.18 (Interquartile range IQR: 0.00;4.25), whereas the spontaneous ABR was 0.00 (IQR: 0.00;1.82), traumatic ABR was 0.00 (IQR: 0.00;1.74) and joint ABR was 0.85 (IQR: 0.00;2.84).
Maltese: Ir-rata medjana ta' fsada f'sena (ABR, annualised bleeding rate) f'adulti u adolexxenti li kienu qed jirċievu Esperoct kienet ta' 1.18 (Interquartile range IQR: 0.00;4.25), filwaqt li l-ABR spontanja kienet 0.00
English: The median and estimated mean annualised bleeding rate in children below 12 years receiving Esperoct twice weekly was 1.95 and 2.13 (95% CI: 1.48;3.06), whereas the spontaneous ABR was 0.00 and 0.58 (95% CI: 0.24;1.40), traumatic ABR was 0.00 and 1.52 (95% CI: 1.07;2.17) and joint ABR was 0.00 and 1.03 (95% CI: 0.59;1.81), respectively.
Maltese: 58 (CI ta' 95%: 0.24;1.40), l-ABR trawmatika kienet 0.00 u 1.52 (CI ta' 95%: 1.07;2.17) u l-ABR konġunta kienet 0.00 u 1.03 (CI ta' 95%: 0.59;1.81).
English: • The active substance is turoctocog alfa pegol (pegylated human coagulation factor VIII (rDNA)).
Maltese: • Is-sustanza attiva hi turoctocog alfa pegol (fattur VIII tal-koagulazzjoni tal-bniedem (rDNA) pegilat).
English: Consider to continue therapy for another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL)
Maltese: Ikkunsidra li tkompli bit-terapija għal 7 ijiem oħra biex iżżomm attività tal-fattur VIII ta' 30% sa 60% (UI/dL)
English: Esperoct was effective in maintaining haemostasis during major surgery with a success rate of 95.6% in all major surgeries performed (43 out of 45 had the effect rated as ‘excellent‘ or ‘good‘).
Maltese: Esperoct kien effettiv fiż-żamma ta' emostasi waqt operazzjoni maġġuri b'rata ta' suċċess ta' 95.6% fl-operazzjonijiet maġġuri kollha mwettqa (43 minn 45 kellhom l-effett evalwat bħala “eċċellenti” jew “tajjeb”).
English: See “Development of ‘FVIII inhibitors' (antibodies)” in section 2.
Maltese: Ara “Żvilupp ta' ‘inibituri ta' FVIII' (antikorpi)” f'sezzjoni 2.
English: Esperoct should be administered by intravenous injection (over approximately 2 minutes) after reconstitution of the powder with 4 mL supplied solvent (sodium chloride 9 mg/mL (0.9%) solution for injection).
Maltese: Esperoct għandu jingħata permezz ta' injezzjoni minn ġol-vini (li ddum madwar 2 minuti) wara rrikostituzzjoni tat-trab b'4 mL tas-solvent ipprovdut (soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride).
English: The overall success rate for the treatment of bleeds was 87.7% and 94.4% of all bleeds treated with 1-2 injections.
Maltese: Ir-rata ta' suċċess in ġenerali għat-trattament ta' episodji ta' fsada kienet ta' 87.7% u 94.4% talepisodji kollha ta' fsada ttrattati b'injezzjoni waħda jew tnejn.
English: Pharmacotherapeutic group: antihemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Maltese: Kategorija farmakoterapewtika: antiemorraġiċi, fattur VIII tal-koagulazzjoni tad-demm, Kodiċi ATC:
English: The mechanism of action of turoctocog alfa pegol is based on the replacement of the deficient or absent factor VIII in patients with haemophilia A. When turoctocog alfa pegol is activated by thrombin at the site of injury, the B-domain containing the PEG moiety and the a3-region are cleaved off, thus generating activated recombinant factor VIII (rFVIIIa) which is similar in structure to native factor VIIIa.
Maltese: Meta turoctocog alfa pegol jiġi attivat mit-thrombin fis-sit tal-korriment, il-B-domain li fih il-parti talPEG u r-reġjun-a3 jiġu separati, b'hekk jiġi ġġenerat il-fattur VIII rikombinat attivat (rFVIIIa, activated recombinant factor VIII) li huwa simili fl-istruttura tiegħu għall-fattur VIIIa nattiv.
English: The medicinal product contains 30.5 mg sodium per reconstituted vial, equivalent to 1.5% of the WHO recommended maximum daily intake of 2.0 g sodium for an adult.
Maltese: Il-prodott mediċinali fih 30.5 mg sodium f'kull kunjett rikostitwit, li huwa ekwivalenti għal 1.5% talkonsum massimu ta' kuljum rrakkomandat mid-WHO li għal adult huwa ta' 2.0 g ta' sodium.
English: A total of 55 of the 120 eligible patients chose to be randomised (17 to the every 4 days dosing and 38 to the 75 IU every 7 days).
Maltese: Total ta'55 mill120 pazjent eliġibbli għażlu li jiġu magħżula b'mod arbitrarju (17 għad-dożaġġ ta' kull 4 ijiem u 38 għal 75 UI kull 7 ijiem).
English: Vial adapter Protective cap
Maltese: Adapter tal-kunjett Għatu protettiv
English: In 12 patients above 18 years of age, 1,126 bleedings were treated among patients receiving on-demand treatment with an average treatment dose of 38.1 IU/kg with a mean annual consumption of 1457 IU/kg.
Maltese: Fi 12-il pazjent ta' età ikbar minn 18-il sena, 1,126 episodju ta' fsada kienu ttrattati fost pazjenti li qed jirċievu trattament skont il-bżonn b'doża medja ta' trattament ta' 38.1 UI/kg b'konsum medju annwali ta' 1457 UI/kg.
English: This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1.5% tal-konsum massimu djetetiku rakkomandat ta' kuljum ta' sodium għal adult.
English: A total of 108 single dose pharmacokinetic profiles at 50 IU/kg Esperoct were evaluated in 69 patients.
Maltese: Ġew evalwati total ta' 108 profili farmakokinetiċi wara doża waħda ta' 50
English: Solvent: sodium chloride, water for injections
Maltese: Solvent: sodium chloride, ilma għall-injezzjonijiet
English: • an infusion set (butterfly needle with tubing)
Maltese: • sett tal-infużjoni (labra butterfly b'pajp irqiq)
English: The single dose pharmacokinetic parameters determined after 28 weeks of prophylactic treatment with Esperoct were consistent with the initial pharmacokinetic parameters.
Maltese: Il-parametri farmakokinetiċi wara doża waħda ddeterminati wara 28 ġimgħa ta' trattament profilattika b'Esperoct kienu konsistenti mal-parametri farmakokinetiċi tal-bidu.
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 pro-coagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Maltese: IgG immirati kontra l-attività favur il-koagulazzjoni tal-fattur VIII, li huma kkwantifikati f'Unitajiet Bethesda (BU - Bethesda Units) f'kull mL ta' plażma bl-użu tal-assaġġ modifikat.
English: After reconstitution with the supplied solvent (sodium chloride 9 mg/mL (0.9%) solution for injection), the prepared solution for injection contains 125, 250, 375, 500 or 750 IU turoctocog alfa pegol per mL, respectively (based on the strength of turoctocog alfa pegol, i.e. 500, 1000, 1500, 2000 or 3000 IU).
Maltese: Wara r-rikostituzzjoni bis-solvent fornut (soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride) is-soluzzjoni għall-injezzjoni ppreparata jkun fiha 125, 250, 375, 500, jew 750
English: Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).
Maltese: Trattament u profilassi ta' fsada f'pazjenti ta' 12-il sena u 'l fuq b'emofilja A (defiċjenza konġenitali tal-fattur VIII).
English: Clinical efficacy of Esperoct during major surgery
Maltese: L-effikaċja klinika ta' Esperoct waqt operazzjoni maġġuri
English: The following side effects have been observed with Esperoct
Maltese: L-effetti sekondarji li ġejjin kienu osservati b'Esperoct
English: 500 IU
Maltese: INDIVIDWALI 500
English: The solvent is a sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Is-solvent huwa soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride.
English: Plunger rod
Maltese: Għatu tassiringa
English: 1000 IU
Maltese: UI, 1000
English: ** Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A. *** Preferred terms included in injection site reactions: Injection site reaction, Vessel puncture site haematoma, Infusion site reaction, Injection site erythema, Injection site rash, Vessel puncture site pain, and Injection site swelling.
Maltese: ** Il-frekwenza hija bbażata fuq studji magħmula fuq il-prodotti kollha ta' fattur VIII li inkludew pazjenti b'emofilja A qawwija. *** Termini ppreferuti inklużi fir-reazzjonijiet fis-sit tal-injezzjoni: Reazzjoni fis-sit tal-injezzjoni, Ematoma fis-sit tat-titqib tal-vina, Reazzjoni fis-sit tal-infużjoni, Eritema fis-sit tal-injezzjoni, Raxx fis-sit tal-injezzjoni, Uġigħ fis-sit tat-titqib tal-vina, u Nefħa fis-sit talinjezzjoni.
English: No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported.
Maltese: Ma kienu rrappurtati l-ebda interazzjonijiet bejn il-fattur VIII uman ta' koagulazzjoni (rDNA) u prodotti mediċinali oħra.
English: Adults/adolescents who had a low bleeding rate of 0-2 bleeding episodes during the last 6 months and had obtained at least 50 doses of Esperoct had the option of being randomised to prophylaxis treatment every 7 days (75 IU/kg every 7 days) or every 4 days (50 IU/kg every 4 days).
Maltese: Adulti/adolexxenti li kellhom rata ta' fsada baxxa ta' 0-2 episodji ta' fsada matul l-aħħar 6 xhur u li kisbu mill-inqas 50 doża ta' Esperoct kellhom l-għażla li b'mod arbitrarju jingħataw trattament ta' profilassi kull 7 ijiem (75 UI/kg kull 7 ijiem) jew kull 4 ijiem (50
English: The required dose is determined using the following formula: Required units (IU) = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL).
Maltese: Unitajiet meħtieġa (UI) = il-piż tal-ġisem (kg) x kemm hu meħtieġ jogħla l-fattur VIII (%) (UI/dL) x 0.5 (UI/kg għal kull UI/dL).
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: MANIFATTUR TAS-SUSTANZA/I)
English: The PEG is attached to the O-linked glycan in the truncated B-domain of rFVIII (turoctocog alfa).
Maltese: Il-PEG huwa marbut mal-O-linked glycan filB-domain imnaqqsa tal-rFVIII (turoctocog alfa).
English: The mean trough plasma factor VIII activity levels at steady-state during prophylactic treatment with Esperoct dosed with 50 IU/kg every 4 days is 3.0 IU/dL (95% CI: 2.6;3.4) in patients 12 years and above.
Maltese: UI/kg kull 4 ijiem huwa ta' 3.0 IU/dL (95% CI: 2.6;3.4) f'pazjenti ta' 12-il sena u 'l fuq.
English: Vial with Esperoct powder
Maltese: X'fih Esperoct
English: • Take out the number of Esperoct packages you need.
Maltese: • Oħroġ in-numru ta' pakketti ta' Esperoct li għandek bżonn.
English: The vast majority of bleeds treated with Esperoct were of mild/moderate severity.
Maltese: Ilmaġġoranza tal-episodji ta' fsada ttrattati b'Esperoct kienu ta' severità ħafifa/moderata.
English: • Check the expiry date.
Maltese: • Iċċekkja d-data ta' skadenza.
English: Of the 68 children below 12 years on prophylaxis, 29 (42.6%) did not have any bleeds.
Maltese: Mit-68 tifel u tifla f'età taħt it-12-il sena fuq profilassi, 29 (42.6%) ma kellhomx fsada.
English: After reconstitution, 1 mL of solution contains approximately 125 IU turoctocog alfa pegol.
Maltese: Wara r-rikostituzzjoni, 1 mL ta' soluzzjoni jkun fiha madwar 125 UI ta' turoctocog alfa pegol.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Maltese: Thrombin imbagħad jibdel fibrinogen f'fibrin u jista' jiġi ffurmat koagulu.
English: The efficacy of Esperoct in the treatment of bleeding episodes was demonstrated in all age groups.
Maltese: L-effikaċja ta' Esperoct fit-trattament ta' episodiji ta' fsada ntweriet fil-gruppi kollha ta' età.
English: Traceability
Maltese: Profilassi
English: Catheter-related problems
Maltese: Problemi marbuta mal-kateter
English: *Human factor VIII, produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cells line, and no additives of human or animal origin are used in the cell culture, purification, conjugation or formulation of Esperoct.
Maltese: *Il-fattur uman VIII, prodott bit-teknoloġija tad-DNA rikombinati f'linja ta' ċelluli tal-Ovarju talĦamster Ċiniż (CHO, Chinese Hamster Ovary), u mingħajr l-użu ta' kwalunkwe addittiv miksub millbniedem jew l-annimali fil-proċess tal-koltura taċ-ċelluli, fil-purifikazzjoni, fil-konjugazzjoni jew filformulazzjoni ta' Esperoct.
English: The single dose pharmacokinetic parameters are comparable between young children (0 to below 6 years) and older children (6 to below 12 years), and between adolescents (12 to17 years) and adults (18 years and above).
Maltese: Il-parametri farmakokinetiċi wara doża waħda huma komparabbli bejn tfal żgħar (età minn 0 sa inqas minn 6 snin) u tfal ikbar (minn 6 snin sa inqas minn 12-il sena), u bejn l-adolexxenti (12 sa 17-il sena) u l-adulti (18-il sena u ikbar).
English: • The ingredients in the solvent are sodium chloride 9 mg/mL (0.9%) solution for injection and water for injections.
Maltese: • Is-sustanzi fis-solvent huma soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride u ilma għall-injezzjonijiet.
English: (pre- and post-operative)
Maltese: (qabel u wara l-operazzjoni)
English: Esperoct contains the active substance turoctocog alfa pegol and is a long-acting recombinant coagulation factor VIII product.
Maltese: Esperoct fih is-sustanza attiva turoctocog alfa pegol u huwa prodott tal-fattur VIII rikombinanti ta' koagulazzjoni li jaħdem fit-tul.
English: After reconstitution, 1 mL of solution contains approximately 375 IU turoctocog alfa pegol.
Maltese: Wara r-rikostituzzjoni, 1 mL ta' soluzzjoni jkun fiha madwar 375 UI ta' turoctocog alfa pegol.
English: This medicine contains 30.5 mg sodium (main component of cooking/table salt) per reconstituted vial.
Maltese: Din il-mediċina fiha 30.5 mg sodium (il-komponent ewlieni tal-melħ tat-tisjir/tal-mejda) f'kull kunjett rikostitwit.
English: There is a risk that you may experience a severe and sudden allergic reaction (e.g. anaphylactic reaction) to Esperoct.
Maltese: Hemm riskju li inti jista' jkollok reazzjoni allerġika f'daqqa u severa (eż. reazzjoni anafilattika) għal Esperoct.
English: More extensive haemarthrosis, muscle bleeding, haematoma
Maltese: Emartrożi aktar estensiva, fsada mill-muskolu,