FrancophonIA/ELRC3.0 huggingface dataset:
English: The available data showed that in many studies including the EUHASS registry (Iorio A, 20174; Fischer K, 20155) the frequency could be classified as “uncommon”.
Maltese: Id-dejta disponibbli wriet li f'ħafna studji inkluż ir-reġistru EUHASS (Iorio A, 20174;
English: For high-titre inhibitors, the hazard ratio was 1.69 (95% CI, 0.96 to 2.98).
Maltese: Għall-inibituri ta' titre għoli, il-proporzjon ta' riskju kien 1.69 (CI ta' 95%, 0.96 sa
English: Similar to RODIN/Pednet, the UKHCDO study found a significant increased risk of inhibitors (all and high titre) for Kogenate FS/Helixate NexGen (2nd generation rFVIII) compared to Advate (3rd generation rFVIII).
Maltese: Simili għal RODIN/Pednet, l-istudju UKHCDO sab riskju miżjud sinifikanti ta' inibituri (kollha u ta' titre għoli) għal Kogenate FS/Helixate NexGen (rFVIII tat-2ni ġenerazzjoni) meta mqabbel ma'
English: Expected factor VIII rise (% of normal) = 2 × administered IU
Maltese: Żieda mistennija ta' fattur VIII (% tan-normal)= 2 × IU mogħtija piż tal-ġisem (kg)
English: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Maltese: Factor VIII products and inhibitor development in severe hemophilia A.
English: This product is indicated for adults, adolescents and children of all ages.
Maltese: Dan il-prodott hu indikat għall-adulti, adolexxenti u tfal ta' kull età.
English: Although this could not have been prevented, an early termination of an open label trial raises the possibility of investigator bias and inflation of the probability of detecting an effect that is not present.
Maltese: Għalkemm dan ma setax jiġi evitat, terminazzjoni bikrija tal-prova open label tqajjem ilpossibbiltà ta' preġudizzju tal-investigatur u żieda tal-probabbiltà li jiġi identifikat effett li mhuwiex preżenti.
English: EXP (End of the 12 month period, if stored at room temperature): ........... Do not use after this date.
Maltese: EXP (Fi tmiem perjodu ta' 12-il xahar jekk maħżun f'temperatura ambjentali): ...........
English: This product is for single use only.
Maltese: prodotti individwali.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
Maltese: IgG, li jaġixxu kontra l-attività pro-koagulanti ta' fattur VIII, u jiġu mkejla f'Unitajiet Bethesda (BU- Bethesda Units) għal kull mL ta' plażma bl-użu tal-analiżi modifikata.
English: KOGENATE Bayer 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.
Maltese: IU fih (250 IU / 2.5 mL) = 100 IU octocog alfa f'kull mL wara rrikostituzzjoni.
English: Catheter-related complications
Maltese: Komplikazzjonijiet relatati mal-kateter
English: KOGENATE Bayer 1000 IU contains (1000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution.
Maltese: IU fih (1000 IU / 2.5 mL) = 400 IU octocog alfa f'kull mL wara rrikostituzzjoni.
English: • The PRAC considered the totality of the data submitted with regards to the risk of inhibitor development for the classes of recombinant and plasma derived FVIII products, in previously untreated patients (PUPs).
Maltese: • Il-PRAC ikkunsidra t-totalità tad-dejta ppreżentata fir-rigward tar-riskju ta' żvilupp talinibituri għall-klassijiet ta' prodotti FVIII rikombinanti u derivati mill-plażma, f'pazjenti li ġew ikkurati preċedentement (PUPs).
English: For most rFVIII products, newer and more relevant information from clinical trials in PUPs is available.
Maltese: Għal ħafna mill-prodotti rFVIII, hemm disponibbli informazzjoni aktar ġdida u aktar relevanti minn provi kliniċi f'PUPs.
English: Furthermore, the PRAC examined clinical trials and the scientific literature for de novo inhibitors in PTPs.
Maltese: Barra minn hekk, il-PRAC eżamina l-provi kliniċi u l-letteratura xjentifika għal inibituri de novo f'PTPs.
English: Each vial of KOGENATE Bayer contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa.
Maltese: Kull kunjett ta' KOGENATE Bayer fih ammont nominali ta' 250, 500, 1000, 2000 jew 3000
English: If the inhibitor is present at levels less than 10 Bethesda Units (BU) per mL, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer.
Maltese: Jekk inibitur huwa preżenti f'livelli inqas minn 10 Bethesda Units (BU) f'kull mL, l-għoti ta' aktar fattur VIII rikombinanti tal-koagulazzjoni għandu mnejn jinnewtralizza l-inibitur u jippermetti li titkompla terapija effettiva klinika b'KOGENATE Bayer.
English: Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 mL/h corresponding to 3.0 mL/h/kg (range 1.6-4.6 mL/h/kg).
Maltese: Tneħħija medja fil-linja bażi għal 14-il pazjent adult li kellhom interventi kirurġiċi maġġuri b'infużjoni kontinwa hija ta' 188 mL/siegħa li tikkorrispondi għal 3.0 mL/siegħa/kg (firxa 1.6-4.6 mL/siegħa/kg).
English: KOGENATE Bayer is used for treatment and prophylaxis of bleeding in adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Maltese: KOGENATE Bayer jintuża għat-trattament u l-profilassi ta' fsada f'adulti, adolexxenti u tfal ta' kull età li għandhom l-emofilja A (nuqqas konġenitali tal-fattur VIII).
English: Table 1: Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/
Maltese: Tabella 1: Gwida għal dożaġġ waqt episodji ta' fsada u kirurġija Qawwa tal-emorraġija/
English: KOGENATE Bayer 250 IU powder and solvent for solution for injection KOGENATE Bayer 500 IU powder and solvent for solution for injection KOGENATE Bayer 1000 IU powder and solvent for solution for injection KOGENATE Bayer 2000 IU powder and solvent for solution for injection KOGENATE Bayer 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni KOGENATE Bayer 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni Fattur VIII rikombinanti tal-koagulazzjoni (octocog alfa)
English: Systemic Hypersensitivit y reactions (including anaphylactic reaction, nausea, blood pressure abnormal and, dizziness)
Maltese: Reazzjonijiet sistemiċi ta' Sensittività Eċċessiva (li jinkludu reazzjoni anafilattika, tqalligħ, pressjoni taddemm mhux normali, u sturdament)
English: General Disorders and Administratio n Site
Maltese: Informazzjoni għall-utent
English: It found that patients treated with rFVIII products had an 87% higher incidence of all inhibitors than those treated with pdFVIII (which contained VWF) (hazard ratio, 1.87; 95% CI, 1.17 to 2.96).
Maltese: Din sabet li pazjenti kkurati bi prodotti rFVIII kellhom inċidenza ogħla ta' 87 % talinibituri kollha minn dawk ikkurati b'pdFVIII (li kien fih VWF) (proporzjon ta' periklu, 1.87; 95% CI, 1.17 sa 2.96).
English: How to store KOGENATE Bayer
Maltese: Tużax KOGENATE Bayer
English: Inhibitor rates in these studies range from 15 to 38% for all inhibitors and 9 to 22.6% for high titre inhibitors; i.e. within the range of ‘very common'.
Maltese: Ir-rati tal-inibituri f'dawn l-istudji jvarjaw minn 15 għal 38 % għall-inibituri kollha u 9 għal 22.6 % għall-inibituri ta' titre għoli; jiġifieri filmedda ta' “komuni ħafna”.
English: The product contains traces of mouse and hamster proteins and human proteins other than factor VIII (see section 5.1).
Maltese: Il-prodott fih traċċi ta' proteini tal-ġurdien u tal-ħamster u proteini umani oħra minbarra fattur VIII (ara sezzjoni 5.1).
English: • hypersensitivity reactions including severe sudden allergic reaction (which may include hives, nausea, urticaria, angioedema, chills, flushing, headache, lethargy, wheezing or difficulty breathing, restlessness, tachycardia, tingling or anaphylactic shock, e.g. tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing)
Maltese: • reazzjonijiet ta' sensittività eċċessiva li jinkludu reazzjoni allerġika severa għal għarrieda (li tista' tinkludu ħorriqija, dardir, urtikarja, anġjoedima, tertir ta' bard, fwawar, uġigħ ta' ras, letarġija, tħarħir jew diffikultà biex tieħu nifs, irrekwitezza, takikardija, tnemnim jew xokk anafilattiku, eż. għafsa fis-sider/tħossok ma tiflaħx, sturdament u dardir u pressjoni tad-demm kemmxejn baxxa , li tista' tagħmlek sturdut waqt li tkun bil-wieqfa)
English: Children and adolescents The listed warnings and precautions apply to patients of all ages, adults and children.
Maltese: It-twissijiet u l-prekawzjonijiet elenkati japplikaw għall-pazjenti ta' kull età, adulti u tfal.
English: • One mL KOGENATE Bayer 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Maltese: IU fih madwar 100 IU (250 IU / 2.5 mL) ta' fattur VIII rikombinanti tal-koagulazzjoni umana (INN: octocog alfa) wara r-rikostituzzjoni b'ilma għallinjezzjonijiet.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Maltese: Filkaż ta' interventi kirurġiċi maġġuri, monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz ta' analiżi tal-koagulazzjoni (attività ta' fattur VIII fil-plażma) huwa indispensabbli.
English: Inhibitors developed in 76 patients, 50 of whom had high-titre inhibitors (≥5 BU).
Maltese: L-inibituri żviluppaw f'76 pazjent, 50 minnhom kellhom inibituri ta' titre għoli (≥5
English: KOGENATE Bayer 250 KOGENATE Bayer 500 KOGENATE Bayer 1000 KOGENATE Bayer 2000 KOGENATE Bayer 3000
Maltese: IU trab għal soluzzjoni għall-injezzjoni KOGENATE Bayer 2000
English: Rarely, inhibitors may develop after the first 100 exposure days.
Maltese: Rarament, wieħed jista' jiżviluppa inibituri wara l-ewwel 100 ġurnata ta' esponiment.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 August 2000
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: ta' 04 Awwissu 2000
English: Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.http://www.bloodjournal.org/content/121/20/4046.full.pdf study, the FranceCoag study also found no statistically significant increased risk for any rFVIII products vs Advate when French patients (also in the RODIN/Pednet study) were excluded.
Maltese: Bħall-istudju UKHCDO, l-istudju FranceCoag ukoll ma sab l-ebda riskju miżjud statistikament sinifikanti għal xi prodotti rFVIII vs Advate meta pazjenti Franċiżi (fl-istudju RODIN/Pednet ukoll) ġew esklużi.
English: Usually, the substitution therapy with KOGENATE Bayer is a life-time treatment.
Maltese: Ġeneralment, it-terapija ta' sostituzzjoni b'KOGENATE Bayer hija trattament tul il-ħajja kollha talpazjent.
English: Infusion rate (in IU/kg/h) = Clearance (in mL/h/kg) × desired factor VIII level (in IU/mL)
Maltese: Rata tal-infużjoni (f'IU/kg/siegħa) = Tneħħija (f'mL/siegħa /kg) × il-livell ta' fattur VIII mixtieq (f'IU/mL).
English: Determination of activated partial thromboplastin time (aPTT) is a conventional in vitro assay method for biological activity of factor VIII.
Maltese: Determinazzjoni tal-ħin ta' tromboplastin parzjali attivat (aPTT - activated partial thromboplastin time) huwa metodu konvenzjonali ta' assaġġ in vitro li jkejjel l-attività bijoloġika ta' fattur VIII. aPTT huwa itwal fil-pazjenti kollha li għandhom l-emofilja.
English: • One mL KOGENATE Bayer 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Maltese: IU fih madwar 400 IU (1000 IU / 2.5 mL) ta' fattur VIII rikombinanti tal-koagulazzjoni umana (INN: octocog alfa) wara r-rikostituzzjoni b'ilma għall-injezzjonijiet.
English: May be stored at temperatures up to 25°C for up to 12 months within the expiry date indicated on the label.
Maltese: Jista' jinħażen f'temperaturi sa 25°C sa 12-il xahar sad-data ta' skadenza indikata fuq it-tikketta.
English: No studies were performed on the mutagenic potential of KOGENATE Bayer, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of KOGENATE Bayer.
Maltese: Ma sarux studji dwar il-potenzjal mutaġeniku ta' KOGENATE Bayer peress li ma seta jiġi osservat lebda potenzjal mutaġeniku in vitro jew in vivo għall-prodott predeċessur ta' KOGENATE Bayer.
English: • The SIPPET study was not designed to evaluate the risk of inhibitor development for individual products, and included a limited number of FVIII products.
Maltese: • L-istudju SIPPET ma tfassalx biex jevalwa r-riskju ta' żvilupp tal-inibituri għal prodotti indivdwali, u inkluda numru limitat ta' prodotti FVIII.
English: Conditions
Maltese: Inibituri
English: • The FVIII products are heterogenous, and the plausibility of different rates of inhibitor development between individual products cannot be excluded.
Maltese: • Il-prodotti FVIII huma eteroġeni, u l-plawżibbiltà ta' rati differenti ta' żvilupp tal-inibituri bejn prodotti individwali ma tistax tiġi eskluża.
English: MAH-sponsored studies
Maltese: TAL-PRODOTT MEDIĊINALI
English: This included published literature (SIPPET study6), data generated in individual clinical trials and a range of observational studies submitted by the marketing authorisation holders, including the data generated in large multicentre cohort studies, data submitted by the national competent authorities of the EU Member States as well as responses provided by the Authors of the SIPPET study.
Maltese: Din inkludiet letteratura ppubblikata (l-istudju SIPPET6), dejta ġġenerata fi provi kliniċi individwali u medda ta' studji ta' osservazzjoni ppreżentati mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq, inkluż id-dejta ġġenerata fi studji ta' koorti multiċentriċi kbar, dejta ppreżentata mill-awtoritajiet nazzjonali kompetenti tal-Istati Membri tal-UE kif ukoll it-tweġibiet ipprovduti mill-Awturi tal-istudju SIPPET.
English: • Finally, the PRAC noted that to date most studies evaluating a differential risk of inhibitor development between classes of FVIII products suffer from a variety of potential methodological limitations and based on the available data considered there is no clear and consistent evidence to suggest differences in relative risk between classes of FVIII products.
Maltese: • Finalment, il-PRAC innota li s'issa ħafna mill-istudji li jevalwaw riskju differenzjali tal-iżvilupp tal-inibituri bejn il-klassijiet ta' prodotti FVIII huma affettwati minn varjetà ta' limitazzjonijiet metodoloġiċi potenzjali u abbażi tad-dejta disponibbli kkunsidra li m'hemm l-ebda evidenza ċara u konsistenti biex tissuġġerixxi differenzi fir-riskju relattiv bejn il klassijiet ta' prodotti FVIII.
English: The responses of MAHs referred to a range of published observational studies (the CANAL, RODIN, FranceCoag, UKHCDO, amongst others) which have sought to evaluate any differential risks of inhibitor development between the classes of pdFVIII and rFVIII, as well as any differential risk of inhibitor development between products within the rFVIII class.
Maltese: It-tweġibiet tal-MAHs irreferew għal medda ta' studji ta' osservazzjoni ppubblikati (il-CANAL, RODIN, FranceCoag, UKHCDO, fost oħrajn) li fittxew li jevalwaw kwalunkwe riskju differenzjali taliżvilupp tal-inibituri bejn il-klassijiet ta' pdFVIII u ta' rFVIII, kif ukoll kwalukwe riskju diferenzjali ta' żvilupp tal-inibituri bejn il-prodotti fil-klass rFVIII.
English: This indicates that the system is activated (D).
Maltese: Dan jindika li s-sistema hija attivata (D).
English: 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: Għal tfal li ma kinux ikkurati qabel b'mediċini li fihom Fattur VIII, antikorpi inibituri (ara sezzjoni 2) jistgħu jiffurmaw b'mod komuni ħafna (aktar minn pazjent 1 minn kull 10); madankollu, pazjenti li jkunu rċivew kura b'Fattur VIII fil-passat (aktar minn 150 jum ta' kura), ir-riskju huwa mhux komuni (inqas minn pazjent 1 minn kull 100).
English: Package Leaflet: Information for the user
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Inhibitors are less likely to occur in previously-treated patients (PTPs).
Maltese: L-inibituri għandhom inqas probabbiltà li jidhru f'pazjenti li jkunu ġew ikkurati preċedentement (PTPs).
English: When you must withdraw blood before an infusion, use an administration set without a filter, then infuse this medicine through an injection filter.
Maltese: Meta jkollok tiġbed id-demm qabel infużjoni, uża sett għall-għoti mingħajr filtru, imbagħad infuża din il-mediċina minn ġewwa filtru tal-injezzjoni.
English: In 2016, PRAC had considered the findings of meta-analysis of all three studies (RODIN/Pednet, UKHCDO and FranceCoag studies), and again concluded that the currently available evidence does not confirm that Kogenate Bayer/Helixate NexGen is associated with an increased risk of factor VIII inhibitors, compared with other recombinant factor VIII products in PUPs.
Maltese: Fl-2016, il-PRAC kien ikkunsidra s-sejbiet tal-metaanaliżi tat-tliet studji kollha (l-istudji RODIN/Pednet, UKHCDO u FranceCoag) u għal darb'oħra kkonkluda li l-evidenza li hemm disponibbli attwalment ma tikkonfermax li Kogenate Bayer/Helixate NexGen huwa assoċjat ma' riskju miżjud ta' inibituri talfattur VIII, meta mqabbel ma' prodotti tal-fattur VIII rikombinanti oħra f'PUPs.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL [for reconstitution of strengths 250/500/1000 IU] 5 mL [for reconstitution of strengths 2000/3000 IU]
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI 2.5 mL [għar-rikostituzzjoni tal-qawwiet 250/500/1000
English: Allergic type hypersensitivity reactions are possible with KOGENATE Bayer.
Maltese: Reazzjonijiet ta' sensittività eċċessiva tat-tip li jikkaġunaw allerġiji huma possibbli b'KOGENATE Bayer.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteremia and catheter site thrombosis should be considered.
Maltese: Jekk tagħmir ta' aċċess venuż ċentrali (CVAD - central venous access device) ikun meħtieġ, ir-riskju ta' komplikazzjonijiet relatati ma' CVAD inkluż infezzjonijiet lokali, batterimja u trombożi fis-sit talkateter, għandu jiġi kkunsidrat.
English: 500 IU (octocog alfa) (200 IU/mL after reconstitution).
Maltese: IU (octocog alfa) (200
English: Data have been obtained from clinical studies in 61 children under 6 years of age and non-interventional studies in children of all ages.
Maltese: Dejta ġiet miksuba minn studji kliniċi f'61 tifel u tifla b'età inqas minn 6 snin u minn studji tal-ebda intervent fi tfal ta' kull età.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% to 2.5% of normal activity.
Maltese: Il-kalkulazzjoni tad-doża meħtieġa ta' fattur VIII hija bbażata fuq sejbiet empiriċi li Unità Internazzjonali (IU - International Unit) waħda ta' fattur VIII għal kull kg ta' piż tal-ġisem, tgħolli lattività tal-fattur VIII fil-plażma b'1.5% sa 2.5% tal-attività normali.
English: Therefore, there is a high degree of uncertainty around extrapolating the SIPPET findings to the entire rFVIII class, particularly for more recentlyauthorised rFVIII products which were not included in the SIPPET trial.
Maltese: għall-klassi kollha rFVIII, partikolarment għal prodotti rFVIII awtorizzati aktar riċentement li ma ġewx inklużi fi-prova SIPPET.
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 with recombinant factor VIII products and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedima, ħruq u tingiż fis-sit tal-infużjoni, tertir ta' bard, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, dardir, nuqqas ta' kwiet, takikardija, għafis tas-sider, tnemnim, rimettar, tħarħir) ġew osservati bi prodotti ta' fattur VIII rikombinanti u f'xi każijiet jistgħu jiżviluppaw f'anafilassi severa (li tinkludi xokk).
English: In 2013, PRAC had concluded that the RODIN/Pednet findings were not sufficiently robust to support a conclusion that Kogenate FS/Helixate NexGen was associated with an increased risk of developing factor VIII inhibitors compared with other products.
Maltese: Fl-2013, il-PRAC kien ikkonkluda li s-sejbiet ta' RODIN/Pednet ma kinux robusti biżżejjed biex jappoġġjaw konklużjoni li Kogenate FS/Helixate NexGen ġie assoċjat ma' riskju miżjud li jiżviluppa inibituri tal-fattur VIII meta mqabbel ma' prodotti oħra.
English: KOGENATE Bayer should be reconstituted and administered with the components provided with each package.
Maltese: KOGENATE Bayer għandu jiġi rikostitwit u mogħti permezz tal-komponenti pprovduti ma' kull pakkett.
English: • With regards to sections 4.8 and 5.1 of the SmPC, the PRAC noted that several FVIII products currently include reference to data from study results which do not allow for a definite conclusion on the inhibitor risk for individual products.
Maltese: • Fir-rigward tas-sezzjonijiet 4.8 u 5.1 tal-SmPC, il-PRAC innota li diversi prodotti FVIII bħalissa jinkludu referenza għal dejta minn riżultati tal-istudju li ma jippermettux li tinstilet konklużjoni definita dwar ir-riskju ta' inibituri għal prodotti individwali.
English: The findings from the SIPPET study, as well as those from the individual clinical trials and observational studies, are not sufficient to confirm any consistent statistically and clinically meaningful differences in inhibitor risk between the rFVIII and pdFVIII product classes.
Maltese: Is-sejbiet mill-istudju SIPPET, kif ukoll dawk mill-provi kliniċi individwali u mill-istudji ta' osservazzjoni, mhumiex biżżejjed biex jikkonfermaw xi differenza statistikament konsistenti u klinikament sinifikanti fir-riskju ta' inibituri bejn klassijiet tal-prodotti rFVIII u pdFVIII.
English: This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Maltese: Din il-preparazzjoni ma fihiex il-fattur von Willebrand u għalhekk mhux indikata fil-marda ta' von Willebrand.
English: 250 IU (octocog alfa) (100 IU/mL after reconstitution).
Maltese: IU (octocog alfa) (100 IU/mL wara r-rikostituzzjoni). 500
English: Treatment with both pdFVIII and rFVIII can lead to development of inhibitors (tested with the Nijmegen method of the Bethesda assay and defined as ≥0.6 Bethesda units (BU) for “a low titre” inhibitor and >5 BU for a “high-titre” inhibitor).
Maltese: Il-kura b'kemm pdFVIII kif ukoll b'rFVIII tista' twassal għall-iżvilupp tal-inibituri (ittestjat bilmetodu ta' Nijmegen tal-assaġġ Bethesda u definit bħala ≥0.6 unitajiet Bethesda (BU, Bethesda units) għal inibitur ta' “titre baxx” u >5 BU għal inibitur ta' “titre għoli”).
English: 1000 IU (octocog alfa) (400 IU/mL after reconstitution).
Maltese: IU (octocog alfa) (400
English: During clinical studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation.
Maltese: Waqt l-istudji, l-ebda pazjent ma żviluppa titres ta' antikorpi ta' rilevanza klinika kontra l-ammonti żgħar ħafna ta' proteini mill-ġrieden u mill-ħamster preżenti fil-preparazzjoni.