FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR and risk management plan summary for Olysio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Olysio is an antiviral medicine that contains the active substance simeprevir.
Maltese: Olysio huwa mediċina antivirali li fiha s-sustanza attiva simeprevir.
English: This is a summary of the European public assessment report (EPAR) for Olysio.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Olysio.
English: The active substance in Olysio, simeprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Maltese: Is-sustanza attiva f'Olysio, is-simeprevir, timblokka l-azzjoni ta' enzima msejħa ‘NS3/4A serine protease' fil-virus tal-epatite Ċ, li hija essenzjali sabiex il-virus jimmultiplika.
English: Three main studies involving 1,178 patients with hepatitis C virus of genotype 1 investigated the combination with peginterferon alfa and ribavirin.
Maltese: Tliet studji ewlenin li involvew 1,178 pazjent bil-virus tal-epatite Ċ ta' ġenotip 1 investigaw ilkombinazzjoni ma' peginterferon alfa u ribavirin.
English: Several varieties (genotypes) of hepatitis C virus exist and Olysio is recommended for patients with virus of genotypes 1 and 4.
Maltese: Jeżistu diversi varjetajiet (ġenotipi) tal-virus tal-epatite Ċ u Olysio huwa rrakkomandat għal pazjenti bil-virus tal-ġenotipi 1 u 4.
English: An analysis of these studies showed that Olysio was less effective in a sub-group of patients infected with hepatitis C virus genotype 1a that has the Q80K mutation.
Maltese: Analiżi ta' dawn l-istudji wriet li Olysio kien inqas effettiv f'subgrupp ta' pazjenti infettati bil-virus talepatite Ċ ġenotip 1a li għandu l-mutazzjoni Q80K.
English: In two of the studies, which involved previously untreated patients, around 80% (419 out of 521) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with 50% (132 out of 264) of patients on placebo.
Maltese: F'żewġ studji, li involvew pazjenti mhux ikkurati, madwar 80% (419 minn 521) tal-pazjenti li kienu qed jieħdu Olysio ttestjaw negattivi għall-epatite Ċ 12-il ġimgħa wara t-tmiem tal-kura, meta mqabbla ma' 50% (132 minn 264) tal-pazjenti fuq plaċebo.
English: How does Olysio work?
Maltese: Kif jaħdem Olysio?
English: In the third study, involving patients whose infections had come back following treatment with interferon-based therapy, around 80% (206 out of 260) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with around 37% (49 out of 133) of
Maltese: Fit-tielet studju, li involvew pazjenti li l-infezzjonijiet tagħhom reġgħu tfaċċaw wara kura b'terapija bbażata fuq interferon, madwar 80% (206 minn 260) tal-pazjenti li kienu qed jieħdu Olysio ttestjaw negattivi għall-epatite Ċ, 12-il ġimgħa wara t-tmiem tal-kura, meta mqabbla ma' madwar 37% (49
English: Additional studies of the combination with peginterferon alfa and ribavirin involving patients with hepatitis C virus of genotype 4 and patients with HIV co-infection showed results consistent with those in patients with genotype 1.
Maltese: Studji addizzjonali tal-kombinazzjoni ma' peginterferon alfa u ribavirin kienu jinvolvu pazjenti bil-virus tal-epatite Ċ tal-ġenotip 4 u pazjenti b'koinfezzjoni tal-HIV urew riżultati konsistenti ma' dawk f'pazjenti b'ġenotip 1.
English: Olysio must be used in combination with other medicines used to treat chronic hepatitis C, such as with peginterferon alfa and ribavirin or with sofosbuvir.
Maltese: Olysio għandu jintuża flimkien ma' mediċini oħrajn użati għall-kura talepatite Ċ kronika, bħal pereżempju ma' peginterferon alfa u ribavirin jew ma' sofosbuvir.
English: Several studies show that Olysio in combination with peginterferon alfa and ribavirin or with sofosbuvir is effective in clearing the hepatitis C virus from the blood after 12 or 24 weeks of treatment.
Maltese: Diversi studji wrew li Olysio flimkien ma' peginterferon alfa u ribavirin jew ma' sofosbuvir huwa effettiv fit-tneħħija tal-virus tal-epatite Ċ mid-demm 12 jew 24 ġimgħa wara l-kura.
English: The Agency also considered that the data available support the use of Olysio in combination with sofosbuvir.
Maltese: LAġenzija kkunsidrat ukoll li d-data disponibbli tappoġġa l-użu ta' Olysio flimkien ma' sofosbuvir.
English: In two additional studies of simeprevir in combination with sofosbuvir in 413 patients, patients without cirrhosis who were taking Olysio together with sofosbuvir had a clearance rate at 12 weeks of 97%, while patients with cirrhosis had a 12 weeks clearance rate of 83%.
Maltese: F'żewġ studji addizzjonali ta' simeprevir flimkien ma' sofosbuvir f'413-il pazjent, pazjenti mingħajr ċirrożi li kienu jieħdu Olysio flimkien ma' sofosbuvir kellhom rata ta' tneħħija ta' 97 % tal-virus wara 12-il ġimgħa, filwaqt li pazjenti b'ċirrożi kellhom rata ta' tneħħija ta' 97 % tal-virus għal 12-il ġimgħa.
English: It is used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.
Maltese: Olysio jintuża fil-kura ta' adulti b'epatite Ċ kronika (fit-tul), marda infettiva li taffettwa l-fwied, ikkawżata mill-virus tal-epatite Ċ.
English: Olysio taken together with sofosbuvir was investigated in a study involving 167 patients, which showed that the combination (with or without ribavirin) cleared infection with hepatitis C genotype 1 in around 90% of patients 12 weeks after the end of treatment.
Maltese: Olysio meħud flimkien ma' sofosbuvir ġie investigat fi studju wieħed li kien jinvolvi 167 pazjent, li wera li din il-kombinazzjoni (b'ribavirin jew mingħajru) neħħiet infezzjoni tal-epatite Ċ ġenotip 1 f'madwar 90% tal-pazjenti 12-il ġimgħa wara t-tmiem tal-kura.
English: The most common side effects during treatment with Olysio (which may affect more than 1 in 10 people) are nausea (feeling sick), rash, pruritus (itching) and dyspnoea (difficulty breathing).
Maltese: L-effetti sekondarji l-aktar komuni matul il-kura b'Olysio (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma nawżja (tħossok ma tiflaħx), raxx, prurite (ħakk), u dispnea (diffikultà fit-teħid tan-nifs).
English: Prolonging treatment to 24 weeks resulted in a clearance rate of above 90%.
Maltese: Il-kura mtawla għal 24 ġimgħa rriżultat f'rata ta' tneħħija ta' ‘l fuq minn 90% tal-virus.
English: Before starting treatment with Olysio, patients with genotypes 1a should have a blood test to check whether the virus they are infected with has a mutation (a change in the genetic material of the virus) called Q80K, as Olysio is known to be less effective in these patients.
Maltese: Qabel tibda l-kura b'Olysio, il-pazjenti bil-ġenotipi 1a għandhom jagħmlu test tad-demm biex jiċċekkjaw jekk il-virus li huma nfettati bih għandux mutazzjoni (bidla fil-materjal ġenetiku tal-virus) imsejjaħ Q80K, minħabba li Olysio huwa magħruf li għandu inqas effett f'dawn ilpazjenti.
English: The company that markets Olysio will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Olysio.
Maltese: Il-kumpanija li tpoġġi Olysio fis-suq ser twettaq studju f'pazjenti li fil-passat kellhom kanċer fil-fwied biex tivvaluta r-riskju li kanċer fil-fwied jerġa' jfeġġ wara l-kura b'antivirali li jaġixxu direttament bħallOlysio.
English: Regarding its safety, Olysio was well tolerated and the side effects were manageable.
Maltese: Firrigward tas-sigurtà tiegħu, Olysio kien ittollerat sew u l-effetti sekondarji kienu maniġġabbli.
English: Osmolality: 500 - 600 mOsm/kg
Maltese: Osmolalità: 500 - 600 mOsm/kg
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IU IDENTIFIKATUR UNIKU - BARCODE 2D
English: ATC code: B02BD02
Maltese: B02BD02
English: The active substance is:
Maltese: Is-sustanza attiva hija:
English: AFSTYLA contains sodium
Maltese: AFSTYLA fih sodium
English: MedDRA System Organ Class
Maltese: Sistema tal Klassifika ta' l Organi Standard MedDRA
English: FVIII inhibition uncommon (PTPs)* very common (PUPs)*
Maltese: Mhux komuni (PTPs)* komuni ħafna (PUPs)*
English: IR (IU/dl)/(IU/kg)
Maltese: IR (UI/dl)/(UI/kg)
English: AUC0-inf (IU*h/dl)
Maltese: AUC0-inf (UI*siegħa/dl)
English: Frequency of doses (hours) / Duration of therapy (days)
Maltese: Frekwenza tad-dożi (sigħat) / Tul ta' żmien tat-terapija (jiem)
English: Date of first authorisation: 04 January 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 04 ta' Jannar 2017
English: • Store in a refrigerator (2 °C to 8 °C).
Maltese: • Aħżen fi friġġ (2 °C sa 8 °C).
English: t1/2 (h)
Maltese: t1/2 (siegħa)
English: EU/1/16/1158/001 EU/1/16/1158/002 EU/1/16/1158/003 EU/1/16/1158/004 EU/1/16/1158/005 EU/1/16/1158/006 EU/1/16/1158/007
Maltese: EU/1/16/1158/001 EU/1/16/1158/002 EU/1/16/1158/003 EU/1/16/1158/004
English: The active substance in AFSTYLA is lonoctocog alfa.
Maltese: Is-sustanza attiva f'AFSTYLA hija lonoctocog alfa.
English: Prophylaxis: 146 subjects were assigned to a prophylaxis regimen (median ABR, 1.14 (interquartile range: 0.0, 4.2)), 79 (54%) were assigned a 3-times per week regimen and 47 (32%) a 2-times per week regimen.
Maltese: Profilassi: 146 individwu kienu assenjati għall-iskeda ta' għoti ta' profilassi (medjan ABR, 1.14 (firxa interkwartili: 0.0, 4.2)), 79 (54%) ġew assenjati skeda ta' għoti ta' 3 darbiet fil-ġimgħa u 47 (32%) skeda ta' għoti ta' darbtejn fil-ġimgħa.
English: Excipient with known effect:
Maltese: Profilassi individwalizzata:
English: AFSTYLA 1500, 2000, 2500 and 3000 IU (5 ml solvent) Each vial contains 35 mg (1.52 mmol) of sodium.
Maltese: AFSTYLA 1500, 2000, 2500 and 3000 UI (5 ml ta' solvent)
English: AFSTYLA 3000 IU
Maltese: AFSTYLA 3000
English: Powder: L-Histidine, Polysorbate 80, Calcium chloride dihydrate, Sodium chloride, Sucrose
Maltese: L-Histidine, Polysorbate 80, Calcium chloride dihydrate, Sodium chloride, Sucrose
English: AFSTYLA 1500 IU
Maltese: AFSTYLA 1500
English: AFSTYLA 250 IU
Maltese: AFSTYLA 250
English: L-Histidine, polysorbate 80, calcium chloride dihydrate, sodium chloride (see last paragraph of section 2), sucrose.
Maltese: L-Histidine, polysorbate 80, calcium chloride di-hydrate, sodium chloride (ara l-aħħar paragrafu ta' sezzjoni 2), sucrose.
English: Treatment of bleeding: Of the 848 bleeding events observed during Study 1001, 93.5% were controlled with 2 or fewer injections.
Maltese: Mit-848 episodju ta' avvenimenti ta' ħruġ ta' demm osservati waqt lIstudju 1001, 93.5% kienu kkontrollati b'2 injezzjonijiet jew anqas.
English: Individualised prophylaxis: Of the 81 patients on prophylaxis (median ABR 3.69 (interquartile range: 0.00, 7.20)), 43 (53%) were assigned to a 2-times weekly regimen and 25 (31%) to a 3-times per week regimen.
Maltese: Mill-81 pazjent fuq profilassi, (ABR medjan 3.69 (firxa interkwartili: 0.00, 7.20)), 43 (53%) ġew assenjati għal skeda ta' għoti tad-dożi darbtejn fil-ġimgħa u 25 (31%) ġew assenjati għal skeda ta' għoti tad-dożi 3 darbiet fil-ġimgħa.
English: Frequencies have been evaluated on a per patient basis 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 tittieħed stima mid-data disponibbli).
English: Dose (IU) = body weight (kg) x Desired factor VIII rise (IU/dl or % of normal) x 0.5 (IU/kg per IU/dl)
Maltese: Doża (UI) = il-piż tal-ġisem (kg) x Żieda mixtieqa fil-fattur VIII (UI/dl jew % tan-normal) x 0.5
English: May be stored at room temperature up to 25 °C for a single 3 months period.
Maltese: Jista' jinħażen f'temperatura ambjentali sa 25 °C għal perjodu wieħed ta' 3 xhur.
English: Paediatric population <12 years of age
Maltese: Popolazzjoni pedjatrika <12-il sena
English: AFSTYLA 2500 IU
Maltese: AFSTYLA 2500
English: Other ingredients: L-Histidine, Polysorbate 80, Calcium chloride dihydrate, Sodium chloride, Sucrose
Maltese: Sustanzi oħra: L-Histidine, Polysorbate 80, Calcium chloride dihydrate, Sodium chloride, Sucrose
English: IR = incremental recovery recorded at 30 minutes after injection; Cmax = maximum concentration, AUC0-inf = area under the factor VIII activity time curve extrapolated to infinity; t1/2 = half-life; MRT = mean residence time; CL = body weight adjusted clearance with N = 80; Vss = body weight adjusted volume of distribution at steady-state.
Maltese: IR (incremental recovery) =irkupru inkrementali mkejjel 30 minuta wara l-injezzjoni; Cmax (maximum concentration) = konċentrazzjoni massima, AUC0-inf (area under curve) = żona taħt il-kurva tal-attività tal-fattur VIII u l-ħin estrapolata sal-infinità; t1/2 (half-life) = ħin meħtieġ biex is-sustanza attiva fil-ġisem tonqos bin-nofs; MRT (mean residence time) = il-medja tal-ħin kemm is-sustanza ddum fil-ġisem; CL (clearance)= tneħħija aġġustata għall-piż tal-ġisem b'N = 80; Vss (volume of distribution at steady state) = volum ta' distribuzzjoni fl-istat fiss aġġustat għallpiż tal-ġisem.
English: VWF stabilizes factor VIII and protects it from degradation.
Maltese: VWF jistabilizza l-fattur VIII u jipproteġih middiżintegrazzjoni.
English: • tingling or numbness (paraesthesia)
Maltese: • tingiż jew titrix (parestesija)
English: Repeat injection every 8 to 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-injezzjoni kull 8 sigħat sa 24 siegħa sakemm ikun hemm fejqan xieraq tal-ġerħa, imbagħad terapija għal mill-inqas 7 ijiem oħra biex tinżamm l-attività ta' 30% sa 60% (UI/dl) tal-fattur VIII.
English: Repeat injection every 8 to 24 hours until threat is resolved.
Maltese: Irrepeti l-injezzjoni kull 8 sigħat sa 24 siegħa sakemm tgħaddi ttheddida.
English: 2.5 ml [for reconstitution of strengths 250/500/1000 IU] 5 ml [for reconstitution of strengths 1500/2000/2500/3000 IU]
Maltese: UI] 5 ml [għar-rikostituzzjoni tal-qawwiet 1500/2000/2500/3000
English: Factor VIII level required (%) (IU/dl)
Maltese: Livell ta' Fattur VIII meħtieġ (%) (UI/dl)
English: CSL Behring GmbH
Maltese: Latvija CSL Behring GmbH
English: AFSTYLA 1000 IU
Maltese: AFSTYLA 1000
English: AFSTYLA is a single-chain recombinant human factor VIII produced in Chinese hamster ovary (CHO) cells.
Maltese: AFSTYLA huwa fattur VIII uman b'katina waħda rikombinat magħmul f'ċelluli tal-ovarju talħamster Ċiniż (CHO - Chinese hamster ovary).
English: AFSTYLA (INN: lonoctocog alfa) is a recombinant human protein that replaces the missing coagulation factor VIII needed for effective hemostasis.
Maltese: AFSTYLA (INN: lonoctocog alfa) huwa proteina rikombinata tal-bniedem li tieħu post ilfattur VIII ta' koagulazzjoni li huwa nieqes u li huwa meħtieġ għal omeostasi effettiva.
English: Activated AFSTYLA has an amino acid sequence identical to endogenous FVIIIa.
Maltese: AFSTYLA attivat għandu s-sekwenza tal-aċidi amminiċi identika għall-FVIIIa endoġenu.
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 (SOC - system organ classification u l-Livell tat-Terminu Ppreferut).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 2.5 ml and 5 ml
Maltese: Tikketta tal-kunjett tas-solvent ta' 2.5 ml u 5 ml
English: IR = incremental recovery recorded at 30 minutes after injection for subjects 12 to < 18 years and at 60 minutes after injection for subjects 1 to < 12 years; Cmax = maximum concentration, AUC = area under the factor VIII activity time curve extrapolated to infinity; t1/2 = half-life; MRT = mean residence time; CL = body weight adjusted clearance; Vss = body weight adjusted volume of distribution at steady-state.
Maltese: IR (incremental recovery) =irkupru inkrementali mkejjel 30 minuta wara l-injezzjoni għal individwi li kellhom minn 12 sa < 18-il sena u 60 minuta wara l-injezzjoni għal individwi li kellhom minn 1 sa < 12-il sena; Cmax (maximum concentration) = konċentrazzjoni massima, AUC (area under curve)= żona taħt il-kurva tal-attività tal-fattur VIII u lħin estrapolata sal-infinità; t1/2 (half-life) = ħin meħtieġ biex is-sustanza attiva fil-ġisem tonqos bin-nofs; MRT (mean residence time) = il-medja tal-ħin kemm is-sustanza ddum fil-ġisem; CL (clearance)= tneħħija aġġustata għall-piż talġisem;
English: AFSTYLA 2000 IU
Maltese: AFSTYLA 2000
English: The study enrolled 175 previously treated patients (12 to 65 years of age) with severe haemophilia A (1 subject >60 years of age was enrolled) who accumulated a total of 14,306 EDs with rVIII-SingleChain.
Maltese: Fl-istudju ġew irreġistrati 175 pazjent (etajiet minn 12 sa 65 sena) b'emofilja A severa li kienu diġà ġew ittrattati qabel (ġie rreġistrat pazjent 1 li kellu >60 sena) li b'kollox akkumulaw total ta' 14,306 EDs b'rVIII b'Katina Waħda.
English: The specific activity of AFSTYLA is 7400 - 16000 IU/mg protein.
Maltese: L-attività speċifika ta' AFSTYLA hija 7,400 - 16,000
English: The study participants accumulated a total of 5,239 EDs with rVIIISingleChain.
Maltese: Il-parteċipanti fl-istudju akkumulaw total ta' 5,239 EDs b'rVIII b'Katina Waħda;
English: Elderly Clinical studies of AFSTYLA did not include subjects over 65 years of age.
Maltese: Anzjani Studji kliniċi ta' AFSTYLA ma nkludewx individwi li kellhom aktar minn 65 sena.
English: • Allergic (hypersensitivity) reactions are possible.
Maltese: • Huma possibbli reazzjonijiet allerġiċi (ta' sensittività eċċessiva).
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Maltese: Trombin imbagħad jibdel fibrinogen f'fibrin u jista' jiġi ffurmat tagħqid tad-demm.
English: Exp. date
Maltese: Data meta JIS
English: AFSTYLA 500 IU
Maltese: AFSTYLA 500
English: MRT (h)
Maltese: MRT (siegħa)
English: Lonoctocog alfa 2000 IU
Maltese: Lonoctocog alfa 2000
English: The pharmacokinetics (PK) of AFSTYLA were evaluated in 10 previously treated adolescents (12 to <18 years of age) and 39 previously treated children (0 to <12 years of age) following an intravenous injection of a single dose of 50 IU/kg.
Maltese: Il-farmakokinetika (PK) ta' AFSTYLA ġiet vvalutata f'10 adolexxenti li kienu diġà ġew ittrattati qabel (b'età minn 12 sa <18-il sena) u 39 tifel u tifla li kienu diġà ġew ittrattati qabel (b'età minn 0 sa <12-il sena) wara injezzjoni ta' doża waħda ta' 50
English: Lonoctocog alfa 250 IU
Maltese: Lonoctocog alfa 250
English: Dizziness common
Maltese: Parestesija komuni
English: Patients on prophylaxis 2- and 3-times per week were assigned median doses of 35 and 30 IU/kg per injection respectively with a median annual consumption across all prophylaxis regimens of 4,283 IU/kg year.
Maltese: Pazjenti fuq profilassi ta' darbtejn u 3 darbiet fil-ġimgħa ġew assenjati dożi medjani ta' 35 u 30 UI/kg f'kull injezzjoni rispettivament b'konsum annwali medjan tul l-iskedi ta' profilassi kollha ta' 4,283 IU/kg sena.
English: • you notice symptoms of allergic reactions Allergic reactions may include the following symptoms: hives, generalised urticaria (itchy rash), tightness of the chest, difficulty in breathing, wheezing, low blood pressure, dizziness, and anaphylaxis.
Maltese: • inti tinnota sintomi ta' reazzjonijiet allerġiċi Reazzjonijiet allerġiċi jistgħu jinkludu s-sintomi li ġejjin: ħorriqija, urtikarja mifruxa (raxx bil-ħakk), tagħfis fis-sider, diffikultà biex tieħu n-nifs, tħarħir, pressjoni baxxa, stordament u anafilassi.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely with the use of factor VIII products and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Reazzjonijiet ta' sensittività eċċessiva jew allerġiċi (li jistgħu jinkludu anġjoedima, ħruq u tingiż filpost 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) ġew osservati b'mod rari bl-użu ta' prodotti tal-fattur VIII u jistgħu f'xi każijiet jiżviluppaw f'anafilassi severa (inkuż xokk).
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 r-riskji ta' kumplikazzjonijiet marbuta ma' CVAD inkluż infezzjonijiet lokali, batterimja u trombożi fis-sit tal-kateter.
English: AFSTYLA 250, 500 and 1000 IU (2.5 ml solvent) Each vial contains 17.5 mg (0.76 mmol) of sodium.
Maltese: Kull kunjett fih 17.5 mg (0.76 mmol) ta' sodium.
English: Adult and adolescent population 12 - 65 years of age Study 1001 determined the efficacy and safety in the prevention of bleeding events in prophylaxis, hemostatic efficacy in the control of bleeding events and during perioperative management.
Maltese: Popolazzjoni adulta u adolexxenti ta' età minn 12 - 65 sena L-istudju 1001 ivvaluta l-effikaċja u s-sigurtà fil-prevenzjoni ta' avvenimenti ta' ħruġ ta' demm filprofilassi u l-effikaċja omeostatika fil-kontroll ta' avvenimenti ta' ħruġ ta' demm u matul limmaniġġjar ta' qabel u wara operazzjonijiet.
English: The pharmacokinetics (PK) of AFSTYLA was evaluated in 81 previously treated adult subjects who had been diagnosed with severe haemophilia A with <1% factor VIII and with age from 1860 years old, following an intravenous injection of 50 IU/kg.
Maltese: Il-farmakokinetika (PK, pharmacokinetics) ta' AFSTYLA ġiet ivvalutata f'81 individwu adult li kienu diġà ġew ittrattati qabel li kellhom dijanjosi ta' emofilja A severa b' <1% ta' fattur VIII u b'eta` minn 18-60 sena, wara injezzjoni minn ġol-vini ta' 50
English: • you notice that the medicine stops working properly (bleeding is not stopped) For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Maltese: • inti tinnota li l-mediċina tieqaf taħdem kif suppost (emorraġija ma tiqafx) Għal tfal li ma kinux ittrattati qabel b'mediċini li fihom il-Fattur VIII, antikorpi inibituri (ara sezzjoni 2) jistgħu jiffurmaw b'mod komuni ħafna (aktar minn pazjent wieħed minn kull 10); madankollu, pazjenti li jkunu rċivew trattament preċedenti bil-fattur VIII fil-passat (aktar minn 150 jum ta' trattament), ir-riskju huwa mhux komuni (inqas minn pazjent wieħed minn kull 100).
English: AFSTYLA can be used in children and adolescents of all ages.
Maltese: AFSTYLA jista' jintuża fit-tfal u adolexxenti ta' kull età.
English: No paediatric subjects <18 years of age were included in the surgery population.
Maltese: Ma ġew inklużi l-ebda individwi pedjatriċi b'età < 18-il sena fil-popolazzjoni kirurġika.
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 diretti lejn l attività prokoagulanti tal fattur VIII, li jiġu kwantifikati f'Unitajiet Bethesda (BU) għal kull ml ta' plażma billi tintuża l analiżi modifikata (modified assay).