FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical discussion
Maltese: Diskussjoni klinika
English: Table 3: Frequency of adverse drug reactions MedDRA
Maltese: Tabella 3: Frekwenza ta' reazzjonijiet avversi tal-mediċina Frekwenza
English: FVIII Inhibition (PTPs)*
Maltese: Inibizzjoni ta' FVIII (PTPs)*
English: Nervous System Disorders
Maltese: Disturbi fissistema nervuża
English: Distribution and elimination
Maltese: Distribuzzjoni u eliminazzjoni
English: Date of latest renewal: 06 August 2010
Maltese: Data tal-aħħar tiġdid: 06 ta' Awwissu 2010
English: Apply a tourniquet.
Maltese: Applika turnikett.
English: 2 plasters
Maltese: 2 stikek
English: FVIII Inhibition (PUPs)*
Maltese: Inibizzjoni ta' FVIII (PUPs)*
English: Other possible side effects:
Maltese: Effetti sekondarji possibbli oħra:
English: Immune System Disorders
Maltese: Disturbi fissistema immuni
English: 4 Iorio A, Barbara AM, Makris M, Fischer K, Castaman G, Catarino C, Gilman E, Kavakli K, Lambert T, Lassila R, Lissitchkov T, Mauser-Bunschoten E, Mingot-Castellano ME0, Ozdemir N1, Pabinger I, Parra R1, Pasi J, Peerlinck K, Rauch A6, Roussel-Robert V, Serban M, Tagliaferri A, Windyga J, Zanon E: Natural history and clinical characteristics of inhibitors in previously treated haemophilia A patients: a case series.
Maltese: Iorio A, Barbara AM, Makris M, Fischer K, Castaman G, Catarino C, Gilman E, Kavakli K, Lambert T, Lassila R, Lissitchkov T, Mauser-Bunschoten E, Mingot-Castellano ME0, Ozdemir N1, Pabinger I, Parra R1, Pasi J, Peerlinck K, Rauch A6, Roussel-Robert V, Serban M, Tagliaferri A, Windyga J, Zanon E:
English: Epub 2015 Jan 8.
Maltese: Epub 2015
English: The specific activity of KOGENATE Bayer is approximately 4000 IU/mg protein.
Maltese: L-attività speċifika ta' KOGENATE Bayer hija madwar 4000 IU/mg ta' proteina.
English: The cumulative incidence of all inhibitors was 26.8% (95% confidence interval [CI], 18.4 to 35.2) with pdFVIII and 44.5% (95% CI, 34.7 to 54.3) with rFVIII; the cumulative incidence of high-titre inhibitors was 18.6% (95% CI, 11.2 to 26.0) and 28.4% (95% CI, 19.6 to 37.2), respectively.
Maltese: 8% (intervall ta' kunfidenza [CI, confidence interval] ta' 95 %, 18.4 sa 35.2) b'pdFVIII u 44.5 % (CI ta' 95%, 34.7 sa 54.3) b'rFVIII; l-inċidenza kumulattiva ta' inibituri ta' titre għoli kienet 18.6 % (CI ta' 95%, 11.2 sa 26.0) u 28.4 % (CI ta' 95%, 19.6 sa 37.2), rispettivament.
English: Recombinant coagulation factor VIII (octocog alfa)
Maltese: Fattur VIII rikombinanti tal-koagulazzjoni (octocog alfa)
English: • Risk Management plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: 60 % (0.6 IU/mL) 1.8 40 % (0.4 IU/mL) 1.2
Maltese: IU/mL) 1.8 40% (0.4
English: OTHER Bayer-Logo
Maltese: OĦRAJN Bayer-Logo
English: Each vial contains nominally 250/500/1000/2000/3000 IU human coagulation factor VIII (INN: octocog alfa).
Maltese: Kull kunjett nominalment fih 250/500/1000/2000/3000 IU ta' fattur VIII tal-koagulazzjoni umana (INN: octocog alfa).
English: LIST OF EXCIPIENTS Glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, sucrose.
Maltese: TA' EĊĊIPJENTI Glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, sucrose.
English: KOGENATE Bayer contains the active substance human recombinant coagulation factor VIII (octocog alfa).
Maltese: KOGENATE Bayer fih is-sustanza attiva Fattur VIII rikombinanti tal-koagulazzjoni uman (octocog alfa).
English: Factor VIII level required (%) (IU/dl)
Maltese: Livell ta'Fattur VIII meħtieġ (%) (IU/dl)
English: 1 F. Peyvandi et al. “A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A” N Engl J Med. 2016 May 26;374(21):2054-64)
Maltese: 1 F. Peyvandi et al. “A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A” N Engl J Med. 2016
English: The PRAC also considered interim results submitted by the MAHs from ongoing studies from CSL (CRD019_5001) and Bayer (Leopold KIDS, 13400, part B.).
Maltese: Il-PRAC ikkunsidra wkoll riżultati interim ippreżentati mill-MAHs minn studji li għadhom għaddejjin minn CSL (CRD019_5001) u Bayer (Leopold KIDS, 13400, parti B.).
English: KOGENATE Bayer can be infused by continuous infusion.
Maltese: KOGENATE Bayer jista' jiġi infuż permezz ta' infużjoni kontinwa.
English: 2017 Mar;23(2):255-263. doi: 10.1111/hae.13167.
Maltese: Haemophilia. 2017 Mar;23(2):255-263. doi: 10.
English: PRAC conclusions
Maltese: Konklużjonijiet tal-PRAC
English: Concentrations of rFVIII solution 100 IU/mL 200 IU/mL 400 IU/mL
Maltese: Konċentrazzjonijiet tas-soluzzjoni ta' rFVIII 100 IU/mL 200 IU/mL 400 IU/mL
English: Name and address of the manufacturer(s) of the biological active substance
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza bijoloġika attiva
English: Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5 II.
Maltese: IU meħtieġa = piż tal-ġisem (kg) × żieda mixtieqa ta' fattur VIII (% tan-normal) × 0.5
English: Infusion rate for 75 kg patient mL/h
Maltese: Rata ta' infużjoni għal pazjent ta' 75 kg f'mL/siegħa
English: The RODIN/Pednet study3 also found no evidence of a class difference in inhibitor risk between all pdFVIII vs all rFVIII; for ‘clinically relevant' inhibitors the adjusted hazard ratio was 0.96 (95% CI 0.62-1.49), and for high titre inhibitors (≥5 BU/ml) was 0.95 (95% CI 0.56-1.61).
Maltese: L-istudju RODIN/Pednet3 ukoll ma sab l-ebda evidenza ta' differenza fil-klassi fir-riskju ta' inibituri bejn pdFVIII kollha vs rFVIII kollha; għall-inibituri “klinikament relevanti” il-proporzjon ta' riskju aġġustat kien ta' 0.96 (95% CI 0.62-1.49), u għall-inibituri ta' titre għoli (≥5 BU/ml) kien ta' 0.95 (95% CI 0.56-1.61).
English: Frequencies have been evaluated according to the following convention: very common: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi ġew evalwati 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-dejta disponibbli).
English: Continuous infusion
Maltese: Infużjoni Kontinwa
English: MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany
Maltese: Bayer AG 51368 Leverkusen
English: Additional pharmacokinetic parameters for KOGENATE Bayer for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 mL/h.
Maltese: Aktar parametri farmakokinetiċi ta' KOGENATE Bayer għall-injezzjoni bolus huma: żmien medju residenzjali [MRT (0-48)] ta' madwar 22 siegħa, u tneħħija ta' madwar 160 mL/siegħa.
English: Rare / not known
Maltese: Rari ħafna / mhux magħruf
English: Clearance: 3 mL/h/kg
Maltese: Tneħħija: 3 mL/siegħa/kg
English: Frequency of doses (hours)/ Duration of therapy (days)
Maltese: Frekwenza tad-dożi (sigħat)/ Tul tat-terapija (ġranet)
English: Vial adapter:
Maltese: Adattatur tal-kunjett:
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: It-tabella ppreżentata hawn taħt hi skont il-klassifika tas-sistemi u tal-organi MedDRA (SOC - system organ classification, u Livell ta' Terminu Preferut).
English: Ad hoc expert group meeting
Maltese: Laqgħa ta' grupp ta' esperti ad hoc
English: In May 2016, an open-label, randomised controlled trial aimed at addressing the incidence of inhibitors between the two classes (pdFVIII vs. rFVIII products) was published in the New England Journal of Medicine1.
Maltese: F'Mejju 2016, prova open-label, randomizzata kkontrollata bl-għan li tindirizza l-inċidenza ta' inibituri bejn iż-żewġ klassijiet (prodotti pdFVIII vs. rFVIII) ġiet ippubblikata fin-New England Journal of Medicine1.
English: Data show that KOGENATE Bayer has been used to induce immune tolerance.
Maltese: Id-dejta turi li KOGENATE Bayer intuża biex jinduċi tolleranza immuni.
English: The PRAC considered the views expressed by experts during an ad-hoc meeting.
Maltese: Il-PRAC ikkunsidra l-fehmiet espressi mill-esperti waqt laqgħa ad hoc.
English: EU/1/00/143/007 - KOGENATE Bayer 250 IU EU/1/00/143/008 - KOGENATE Bayer 500 IU EU/1/00/143/009 - KOGENATE Bayer 1000 IU EU/1/00/143/011 - KOGENATE Bayer 2000 IU EU/1/00/143/013 - KOGENATE Bayer 3000 IU
Maltese: IU EU/1/00/143/009 - KOGENATE Bayer 1000 IU EU/1/00/143/011 - KOGENATE Bayer 2000
English: EU/1/00/143/004 - KOGENATE Bayer 250 IU EU/1/00/143/005 - KOGENATE Bayer 500 IU EU/1/00/143/006 - KOGENATE Bayer 1000 IU EU/1/00/143/010 - KOGENATE Bayer 2000 IU EU/1/00/143/012 - KOGENATE Bayer 3000 IU
Maltese: IU EU/1/00/143/006 - KOGENATE Bayer 1000 IU EU/1/00/143/010 - KOGENATE Bayer 2000
English: • Patient-related risk factors include type of F8 gene mutation, severity of haemophilia, ethnicity, family history of inhibitor development and possibly HLA-DR (Human Leukocyte Antigen - antigen D Related) constitution.
Maltese: • Fatturi ta' riskju relatati mal-pazjent jinkludu t-tip ta' mutazzjoni tal-ġene F8, is-severità talemofilja, l-etniċità, storja familjari ta' żvilupp tal-inibituri u possibbilment il-kostituzzjoni ta' HLA-DR (Antiġen Lewkoċitarju tal-Bniedem - Relatat ma' antiġen D, Human Leukocyte Antigen - antigen D Related).
English: KOGENATE Bayer contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials.
Maltese: KOGENATE Bayer fih livell baxx ta' polysorbate-80 bħala sustanza mhux attiva li hu magħruf li jżid ir-rata ta' estrazzjoni ta' di-(2-ethylhexyl)phthalate (DEHP) minn materjali magħmula minn polyvinyl chloride (PVC).
English: • There were also deviations from the final protocol and statistical analysis plan.
Maltese: • Kien hemm ukoll devjazzjonijiet mill-protokoll finali u mill-pjan ta' analiżi statistika.
English: Apply a tourniquet to your arm 13.
Maltese: Applika turnikett ma dirgħajk 13.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection (Bio-Set System).
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni (Sistema Bio-Set).
English: Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code B02BD02.
Maltese: Kategorija farmakoterapewtika: mediċini kontra emorraġija: fattur VIII tal-koagulazzjoni tad-demm, Kodiċi ATC:
English: The CANAL study2 found no evidence of a class difference, including pdFVIII products with considerable quantities of von Willebrand factor; for ‘clinically relevant' inhibitors the adjusted hazard ratio was 0.7 (95% CI 0.4-1.1), and for high titre inhibitors (≥5 BU) was 0.8 (95% CI 0.4
Maltese: L-istudju CANAL2 ma sab l-ebda evidenza ta' differenza fil-klassi, inkluż prodotti pdFVIII bi kwantitajiet konsiderevoli tal-fattur von Willebrandl; għall-inibituri “klinikament relevanti” ilproporzjon ta' riskju aġġustat kien ta' 0.7 (95% CI 0.4-1.1), u għall-inibituri ta' titre għoli (≥5 BU) kien ta' 0.8 (95% CI 0.4-1.3).
English: A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Maltese: Imbagħad thrombin ibiddel fibrinogen għal fibrin u b'hekk id-demm ikun jista' jagħqad.
English: a) By bolus infusions Repeat infusion every 8 - 24 hours until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Maltese: a) Permezz ta' infużjonijiet bolus Irrepeti l-infużjoni kull 8 - 24 siegħa sakemm ikun hemm fejqan adegwat tal-ferita, u wara kompli bit-terapija għal mill-anqas 7 ijiem oħra biex tinżamm attività ta' fattur VIII ta' 30% sa 60% (IU/dl).
English: • local reactions where you injected the medication (e.g. burning sensation, temporary redness)
Maltese: • reazzjonijiet lokali fil-post fejn tkun injettajt il-mediċina (eż. sensazzjoni ta' ħruq, ħmura temporanja)
English: Infusion rate IU/h/kg
Maltese: Rata ta' infużjoni IU/siegħa/kg
English: Annex IV Scientific conclusions
Maltese: Anness IV Konklużjonijiet xjentifiċi
English: 3000 IU (octocog alfa) (600 IU/mL after reconstitution).
Maltese: 3000 IU (octocog alfa) (600 IU/mL wara r-rikostituzzjoni).
English: The PRAC adopted a recommendation on 01 September 2017 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Fl-1 ta' Settembru 2017, il-PRAC adotta rakkomandazzjoni li dak iż-żmien ġiet ikkunsidrata misCHMP, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
English: Every 24 hours, at least 1 day, until healing is achieved.
Maltese: Kull 24 siegħa, għal mill-anqas ġurnata, sa meta jkun hemm fejqan.
English: • rash/itchy rash
Maltese: • raxx/raxx bil-ħakk
English: Differences between products in each FVIII class and consequently differential risks between individual products, are biologically plausible.
Maltese: Id-differenzi bejn il-prodotti f'kull klassi FVIII u konsegwentement riskji differenzjali bejn prodotti individwali, huma bijoloġikament plawżibbli.
English: Having considered the abovementioned results from SIPPET, the published literature and all the information submitted by the MAHs, as well as the views expressed by experts expressed at the ad-hoc expert meeting, the PRAC concluded that:
Maltese: Meta jiġu kkunsidrati r-riżultati ta' hawn fuq minn SIPPET, il-letteratura ppublikata u linformazzjoni kollha ppreżentata mill-MAHs, kif ukoll il-fehmiet espressi mill-esperti fil-laqgħa ta' esperti ad hoc, il-PRAC ikkonkluda li:
English: A retrospective review has been done on 40 patients, and 39 patients were included in a prospective investigator-initiated clinical study.
Maltese: Saret analiżi retrospettiva fuq 40 pazjent, u 39 pazjent ġew inklużi fi studju kliniku prospettiv li nbeda mill-investigatur.
English: For continuous infusion, clinical and in vitro stability has been demonstrated using ambulatory pumps with a PVC reservoir.
Maltese: Għall-infużjoni kontinwa, stabbilità klinika u in vitro ġiet murija permezz ta' pompi ambulatorji b'kompartiment tal-PVC.
English: KOGENATE Bayer should be injected intravenously over 2 to 5 minutes.
Maltese: KOGENATE Bayer għandu jiġi injettat fil-vini fuq medda ta' 2 sa 5 minuti.
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously untreated patients
Maltese: PTPs = pazjenti kkurati qabel, PUPs (previously untreated patients) = pazjenti li ma ġewx ittrattati filpassat
English: The primary and secondary outcomes assessed in the study were the incidence of all inhibitors (≥0.4 BU/ml) and the incidence of high-titre inhibitors (≥5 BU/ml), respectively.
Maltese: BU/ml) u l-inċidenza ta' inibituri ta' titre għoli (≥5 BU/ml), rispettivament.
English: In Cox regression models for the primary end point of all inhibitors, rFVIII was associated with an 87% higher incidence than pdFVIII (hazard ratio, 1.87; 95% CI, 1.17 to 2.96).
Maltese: F'mudelli ta' rigressjoni Cox għall-end-point primarju talinibituri kollha, rFVIII ġie assoċjat ma' inċidenza ogħla ta' 87 % milli pdFVIII (proporzjon ta' riskju, 1.87; CI ta' 95%, 1.17 sa 2.96).
English: The active substance is human coagulation factor VIII (octocog alfa) produced by recombinant DNA technology.
Maltese: Is-sustanza attiva hi l-Fattur VIII tal-koagulazzjoni umana (octocog alfa) magħmul permezz ta' teknoloġija tat-tfassil tad-DNA.
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, għandu jiġi mplimentat trattament mediku standard għal xokk.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for human plasma derived and recombinant coagulation factor VIII containing medicinal products (see Annex I and Annex A).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE li tirriżulta minn dejta ta' farmakoviġilanza, għall-prodotti mediċinali li fihom il-fattur ta' koagulazzjoni VIII tal-bniedem derivat mill-plażma u rikombinanti (ara Anness I u Anness A).
English: For calculation of mL/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/mL).
Maltese: Għal kalkulazzjoni ta' mL/siegħa, immultiplika r-rata tal-infużjoni f'IU/siegħa/kg b'kg/bw/konċentrazzjoni tas-soluzzjoni (IU/mL).
English: • you require a central venous access device (CVAD) for the administration of KOGENATE Bayer.
Maltese: • teħtieġ tagħmir ta' aċċess venuż ċentrali (CVAD - central venous access device) għall-għoti ta' KOGENATE Bayer.
English: Rare (may affect up to 1 in 1,000 users):
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda li qed tużah minn kull 1,000):
English: However, despite the lack of robust evidence to support differential risks between rFVIII products, differential risks cannot be excluded, as this is a heterogeneous product class with differences in composition and formulations.
Maltese: Madankollu, minkejja n-nuqqas ta' evidenza robusta biex tappoġġja riskji differenzjali bejn prodotti rFVIII, ma jistgħux jiġu esklużi riskji differenzjali, peress li din hija klassi tal-prodott eteroġena b'differenzi fil-kompożizzjoni u fil-formulazzjonijiet.
English: Type of surgical procedure
Maltese: Tip ta' proċedura kirurġika
English: Other medicines and KOGENATE Bayer
Maltese: Mediċini oħra u KOGENATE Bayer
English: The PRAC consulted an ad-hoc expert meeting on some of the aspects that formed part of the detailed grounds submitted by LFB Biomedicaments.
Maltese: Il-PRAC ikkunsidra laqgħa tal-esperti ad hoc dwar xi aspetti li jiffurmaw parti mir-raġunijiet iddettaljati ppreżentati minn LFB Biomedicaments.
English: The SIPPET study was an open-label, randomized, multi-centre, multi-national trial investigating the incidence of neutralising allo-antibodies in patients with severe congenital haemophilia A (plasma FVIII concentration<1%) with either the use of pdFVIII or rFVIII concentrates.
Maltese: L-istudju SIPPET kien prova open-label, randomizzata, multiċentrika, multinazzjonali li tinvestiga linċidenza ta' allo-antikorpi newtralizzanti f'pazjenti b'emofilja A konġenitali severa (konċentrazzjoni ta' FVIII fil-plażma ta' <1%) b'jew l-użu ta' konċentrati pdFVIII jew rFVIII.
English: However, the study found evidence of an increased risk of inhibitors (all and high titre) for 2nd generation rFVIII octocog alfa (Kogenate FS/Helixate NexGen) compared with 3rd generation rFVIII octocog alfa (which was driven solely by data for Advate).
Maltese: Madankollu, l-istudju sab evidenza ta' riskju miżjud ta' inibituri (kollha u ta' titre għoli) għat-2niġenerazzjoni rFVIII octocog alfa (Kogenate FS/Helixate NexGen) meta mqabbel mat-3et ġenerazzjoni rFVIII octocog alfa (li kien xprunat biss minn dejta għal Advate).
English: There are no fertility data available.
Maltese: M'hemmx dejta disponibbli dwar il-fertilità.
English: Remove tourniquet!
Maltese: Neħħi t-turnikett!
English: The other ingredients are glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, and sucrose (see end of section 2).
Maltese: Is-sustanzi l-oħra huma glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, u sucrose (ara t-tmiem ta' sezzjoni 2).
English: These compatible filters are luer adaptor-type of Polyacrylic housing with integrated filter element of a Polyamide screen of 5 - 20 micrometer mesh size.
Maltese: Dawn il-filtri kompatibbli huma tat-tip luer adaptor magħmula minn qafas ta' Polyacrylic b'element għall-iffiltrar integrat magħmul minn xibka ta' Polyamide b'daqs tal-malja ta' 5-20 mikrometru.
English: Following the adoption of the PRAC recommendation during the May 2017 PRAC meeting, the MAH LFB Biomedicaments expressed their disagreement with the initial PRAC recommendation.
Maltese: Wara l-adozzjoni tar-rakkomandazzjoni tal-PRAC matul il-laqgħa tal-PRAC ta' Mejju 2017, il-MAH LFB Biomedicaments esprima n-nuqqas ta' qbil tiegħu mar-rakkomandazzjoni inizjali tal-PRAC.
English: The safety and efficacy of KOGENATE Bayer in children of all ages have been established.
Maltese: Is-sigurtà u l-effikaċja ta' KOGENATE Bayer fit-tfal ta' kull età ġew determinati.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment “ħieles mis-sodium”.
English: • Inhibitor development is an identified risk with both pdFVIII and rFVIII products.
Maltese: • L-iżvilupp tal-inibituri huwa riskju identifikat kemm fi prodotti pdFVIII kif ukoll fi prodotti rFVIII.
English: The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions.
Maltese: Il-kumpless tal-fattur VIII/fattur von Willebrand (vWF - von Willebrand factor) huwa magħmul minn żewġ molekuli (fattur VIII u vWF) li għandhom funzjonijiet fiżjoloġiċi differenti.
English: However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion.
Maltese: Madankollu, waqt studji in vitro, l-istabbilità kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 30°C f'boroż tal-PVC għall-infużjoni kontinwa.
English: No interactions of KOGENATE Bayer with other medicinal products have been reported.
Maltese: Ma ġiet irrappurtata l-ebda interazzjoni ta' KOGENATE Bayer ma' prodotti mediċinali oħra.
English: The pdFVIII class consists of products with or without Von Willebrand Factor (VWF), and those with VWF contain a range of VWF levels.
Maltese: Ilklassi pdFVIII tikkonsisti minn prodotti bi jew mingħajr il-Fattur Von Willebrand (VWF, Von Willebrand Factor) u dawk b'VWF fihom medda ta' livelli VWF.
English: Inhibitors developed in 29 of the 125 patients treated with pdFVIII (20 patients had high-titre inhibitors) and in 47 of the 126 patients treated with rFVIII (30 patients had high-titre inhibitors).
Maltese: L-inibituri żviluppaw f'29 mill-125 pazjent ikkurati b'pdFVIII (20 pazjent kellhom inibituri ta' titre għoli) u f'47 mill-126 pazjent ikkurati b'rFVIII (30 pazjent kellhom inibituri ta' titre għoli).
English: FVIII replacement therapy can be generally categorised into two broad classes of products; plasma derived (pdFVIII) and recombinant (rFVIII) FVIII.
Maltese: FVIII derivat mill-plażma (pdFVIII) u rikombinanti (rFVIII).
English: Skin associated hypersensitivity reactions, (pruritus, urticaria and rash)
Maltese: Reazzjonijiet ta' sensittività eċċessiva marbuta malġilda, (ħakk, urtikarja u raxx)
English: KOGENATE Bayer contains sodium
Maltese: KOGENATE Bayer fih is-sodium
English: • syringe plunger rod
Maltese: • is-severità tal-emofilja tiegħek
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Bayer AG 51368 Leverkusen
English: 6 Peyvandi F, Mannucci PM, Garagiola I, et al. A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A. The New England journal of medicine 2016 May 26;374(21):2054-64
Maltese: A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A. The New England journal of medicine 2016
English: Data on Immune Tolerance Induction have been collected in patients with haemophilia A who had developed inhibitors to FVIII.
Maltese: Natural history and clinical characteristics of inhibitors in previously treated haemophilia A patients: a case series.
English: • if you are allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6 and end of section 2).
Maltese: • jekk inti allerġiku għal octocog alfa jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6 u t-tmiem ta' sezzjoni 2).
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3