FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism.
Maltese: L-użu ta' prodotti b'purità baxxa ta' fattur IX ġie assoċjat ma' każijiet ta' infart mijokardijaku, koagulazzjoni intravaskulari mifruxa, trombożi venuża u emboliżmu pulmonari.
English: < 6years (N=11)
Maltese: < 6 snin (N=11)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates and published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature not above 30°C.
Maltese: L-istabbilità kimika u fiżika waqt l-użu ntweriet għal 3 sigħat f'temperatura ta' mhux aktar minn 30°C.
English: • one vial of RIXUBIS 250, 500, 1000, 2000 or 3000 IU powder in a glass vial with a rubber stopper
Maltese: • kunjett wieħed ta' RIXUBIS 250, 500, 1000, 2000 jew 3000 IU trab f'kunjett tal-ħġieġ b'tapp tal-lastku
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Mean±SD Median (range)
Maltese: Medja±SD Medjan (medda)
English: Prophylaxis and control of bleeding in previously treated patients 12 years and older The efficacy of RIXUBIS has been evaluated in the open-label, uncontrolled part of a combined phase 1/3 study, in which a total of 73 male, previously treated patients (PTPs) between 12 and 59 years of age received RIXUBIS either for prophylaxis and/or for the treatment of bleeding episodes on an on-demand basis.
Maltese: Profilassi u kontroll ta' ħruġ ta' demm f'pazjenti kkurati fil-passat li jkollhom 12-il sena u aktar L-effikaċja ta' RIXUBIS ġiet evalwata fil-parti mhux ikkontrollata ta' studju open-label, kombinat, ta' fażi 1/3, li fih total ta' 73 pazjent irġiel, ikkurati fil-passat (PTPs), li kellhom bejn 12 u 59 sena, irċivew RIXUBIS jew għall-profilassi u/jew għall-kura ta' episodji ta' ħruġ ta' demm fuq bażi ta' kura fil-pront.
English: Intravenous use.
Maltese: Uża immedjatament.
English: Continuous infusion Do not administer RIXUBIS by continuous infusion.
Maltese: Infużjoni kontinwa Tagħtix RIXUBIS permezz ta' infużjoni kontinwa.
English: PK (ED 1) All (N=10)
Maltese: PK (ED 1) Kollha (N=10)
English: Median (range) Incremental recovery at Cmax (IU/dL:IU/kg)
Maltese: Medjan (medda) Irkuprar inkrementali fis-Cmax (IU/dL:IU/kg)b
English: Week 13 (N=68)
Maltese: Ġimgħa 13 (N=68)
English: The specific activity of RIXUBIS is approximately 200-390 IU/mg protein.
Maltese: L-attività speċifika ta' RIXUBIS hi ta' madwar 200-390
English: Exposure Day 1 (N=73)
Maltese: Jum 1 talEsponiment (N=73)
English: The mean (± SD) and median dose of RIXUBIS in the full analysis set (n=23) was 75.50 ± 3.016 and 75.25 IU/kg, respectively, with a range of 70.0 to 83.6 IU/kg.
Maltese: Id-doża medja (± SD) u d-doża medjana ta' RIXUBIS fis-sett sħiħ ta' analiżi (n=23) kienu ta' 75.50 ± 3.016 u 75.25
English: What RIXUBIS contains - The active substance is nonacog gamma (recombinant human coagulation Factor IX).
Maltese: X'fih RIXUBIS - Is-sustanza attiva nonacog gamma (Fattur IX tal-koagulazzjoni umana rikombinanti).
English: Contents: 1 powder vial, 1 solvent vial, 1 BAXJECT II device
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: 1 kunjett bit-trab, 1 kunjett bis-solvent, 1 tagħmir BAXJECT II
English: PK (ED 1) All (N=12)
Maltese: PK (ED 1) Kollha (N=12)
English: Administration Use Aseptic Technique
Maltese: Għoti Uża Teknika Asettika
English: PK (ED 1) All (N=22)
Maltese: PK (ED 1) Kollha (N=22)
English: These measures will help to protect the environment.
Maltese: IU/mg ta' proteina.
English: Incremental recovery for RIXUBIS 30 minutes after infusion, paediatric patients 6 to < 12 years:
Maltese: Irkuprar inkrementali għal RIXUBIS 30 minuta wara l-infużjoni, pazjenti pedjatriċi ta' minn 6 sa < 12-il sena:
English: It is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line.
Maltese: Hu magħmul minn teknoloġija ta' DNA rikombinanti fl-ovarju tal-ħamster Ċiniż (CHO).
English: Degree of haemorrhage/Type of surgical procedure
Maltese: Grad ta' emorraġija/Tip ta' proċedura kirurġika
English: Side effects with unknown frequency (frequency cannot be estimated from the available data) - allergic reactions (hypersensitivity).
Maltese: Effetti sekondarji bi frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli) - reazzjonijiet allerġiċi (sensittività eċċessiva).
English: Calculated as (C30min-baseline factor IX) divided by the dose in IU/kg, where C30min is the factor IX measurement 30 minutes after infusion.
Maltese: Ikkalkulat bħala (C30min fattur IX fil-linja bażi) diviża bid-doża f'IU/kg, fejn C30min hu l-kejl ta' fattur IX 30 minuta wara l-infużjoni.
English: Paediatric population (previously treated patients younger than 12 years)
Maltese: Popolazzjoni pedjatrika (pazjenti kkurati fil-passat li kellhom inqas minn 12-il sena)
English: The mean (± SD) and median dose of RIXUBIS in the per protocol analysis set (n=25) were 74.69±2.37 and 74.25 IU/kg, respectively, with a range of 71.27 to 79.38 IU/kg.
Maltese: Id-doża medja (± SD) u d-doża medjana ta' RIXUBIS fis-sett ta' analiżi skont il-protokoll (n=25) kienu ta' 74.69±2.37 u 74.25
English: Incremental recovery for RIXUBIS 30 minutes after infusion, paediatric patients < 6 years:
Maltese: Irkuprar inkrementali għal RIXUBIS 30 minuta wara l-infużjoni, pazjenti pedjatriċi ta' < 6 snin:
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors.
Maltese: Sindrome nefrotiku ġie rrappurtat wara attentat ta' induzzjoni ta' tolleranza immuni f'pazjenti b'emofilija B b'inibituri ta' fattur IX.
English: Frequency of doses (hours)/Duration of therapy (days)
Maltese: Frekwenza tad-dożi (sigħat)/ Dewmien tat-terapija (ġranet)
English: The per-protocol efficacy analysis includes 37 surgeries performed in 27 patients between 17 and 57 years of age undergoing major or minor surgical, dental or other surgical invasive procedures.
Maltese: L-analiżi tal-effikaċja skont il-protokoll tinkludi 37 operazzjoni mwettqa fuq 27 pazjent ta' bejn is-17 u 57 sena li kellhom proċeduri kirurġiċi maġġuri jew minuri, dentali jew proċeduri invażivi oħrajn.
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 rarely and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjodema, ħruq u tingiż fis-sit tal-infużjoni, tertir ta' bard, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, dardir, nuqqas ta' kwiet f'ġismek, takikardija, tagħfis tas-sider, tnemnim, rimettar, tħarħir) ġew osservati b'mod rari u jistgħu f'xi każijiet jaggravaw għal anafilassi severa (li tinkludi xokk).
English: The following side effects have been observed with RIXUBIS:
Maltese: L-effetti sekondarji li ġejjin ġew osservati b'RIXUBIS:
English: No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Maltese: Ma ġew irrappurtati l-ebda interazzjonijiet ta' prodotti li fihom fattur IX tal-koagulazzjoni umana (rDNA) ma' prodotti mediċinali oħrajn.
English: Incremental recovery 30 minutes after infusion was determined for all subjects in the combined phase 2/3 study at the initial pharmacokinetic evaluation (exposure day 1), at week 5, 13, and 26 visits, and at the time of study completion or termination, if it did not coincide with the week 26 visit.
Maltese: L-irkuprar inkrementali 30 minuta wara l-infużjoni ġie determinat għall-individwi kollha fl-istudju kombinat ta' fażi 2/3 fl-evalwazzjoni farmakokinetika inizjali (jum l tal-esponiment), fil-visti ta' ġimgħa 5, 13, u 26, u fil-ħin meta tlesta jew intemm l-istudju, jekk ma kienx jikkoinċidi mal-vista ta' ġimgħa 26.
English: • one BAXJECT II (needle-less reconstitution device)
Maltese: • BAXJECT II wieħed (tagħmir għar-rikostituzzjoni bla labra)
English: Incremental recovery for RIXUBIS 30 minutes after infusion, both paediatric age groups:
Maltese: Irkuprar inkrementali għal RIXUBIS 30 minuta wara l-infużjoni, għaż-żewġ gruppi ta' età pedjatriċi:
English: Repeat infusion every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30% to 60% (IU/dl).
Maltese: Irrepeti l-infużjoni kull 8 sa 24 siegħa sakemm jinkiseb fejqan adegwat tal-ferita, imbagħad kompli t-terapija għal mill-inqas 7 ijiem oħra biex iżżomm attività ta' fattur IX ta' 30% sa 60% (IU/dL).
English: Known allergic reaction to hamster protein.
Maltese: Reazzjoni allerġika magħrufa għal proteina tal-ħamster.
English: RIXUBIS 1000 IU powder for injection nonacog gamma
Maltese: RIXUBIS 1000 IU trab għal soluzzjoni għall-injezzjoni nonacog gamma
English: RIXUBIS was not thrombogenic at a dose of 750 IU/kg in a rabbit stasis model (Wessler-Test).
Maltese: IU/kg fil-mudell stasis tal-fniek (Wessler Test).
English: Other medicines and RIXUBIS
Maltese: Mediċini oħra u RIXUBIS
English: Reconstitution Use Aseptic Technique
Maltese: Rikostituzzjoni Uża Teknika Asettika
English: Such reactions may include burning sensations and stinging at the infusion site, chills, flushing, lethargy, restlessness, tingling, hives, itching and rash, low blood pressure, fast heart rate, tightness of the chest, wheezing, swelling of the throat, anaphylaxis (severe allergic reaction), headache, nausea and vomiting.
Maltese: Reazzjonijiet bħal dawn jistgħu jinkludu sensazzjonijiet ta' ħruq u tingiż fis-sit tal-infużjoni, tertir ta' bard, fwawar, telqa, nuqqas ta' kwiet f'ġismek, tingiż, ħorriqija, ħakk u raxx, pressjoni tad-demm baxxa, rata mgħaġġla ta' taħbit tal-qalb, tagħfis tas-sider, tħarħir, nefħa tal-gerżuma, anafilassi (reazzjoni allerġika severa), uġigħ ta' ras, dardir u rimettar.
English: The vacuum will draw the solvent into the RIXUBIS vial (Fig. c).
Maltese: Il-vakwu se jiġbed is-solvent ġol-kunjett b'RIXUBIS (Fig. ċ).
English: The recommended dose range for paediatric patients less than 12 years is 40 to 80 IU/kg at intervals of 3 to 4 days.
Maltese: Il-medda rakkomandata tad-doża għal pazjenti pedjatriċi li jkollhom inqas minn 12-il sena hi ta' 40 sa 80 IU/kg f'intervalli ta' 3 sa 4 ijiem.
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Maltese: Minħabba r-riskju potenzjali ta' kumplikazzjonijiet trombotiċi, sorveljanza klinika għal sinjali bikrija ta' koagulopatija trombotika u konsumattiva għandha tinbeda b'ittestjar bijoloġiku xieraq meta dan il-prodott jingħata lil pazjenti b'mard tal-fwied, lil pazjenti wara operazzjoni, lil trabi tat-twelid, jew lil pazjenti f'riskju ta' fenomeni trombotiċi jew DIC.
English: Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin.
Maltese: Fattur X attivat jikkonverti protrombin fi thrombin.
English: The median ABR was 2.0, for spontaneous bleeds 0.0 and for joint bleeds 0.0.
Maltese: L-ABR medjan kien ta' 2.0, għal ħruġ ta' demm spontanju 0.0, u għal ħruġ ta' demm konġunt 0.0.
English: The pharmacokinetic parameters were calculated from factor IX activitiy measurements in blood samples obtained up to 72 hours following each infusion.
Maltese: Il-parametri farmakokinetiċi ġew ikkalkulati minn kejl tal-attività ta' fattur IX fil-kampjuni tad-demm miksuba sa 72 siegħa wara kull infużjoni.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Maltese: B'mod partikulari, fil-każ ta' interventi kirurġiċi maġġuri, monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz ta' analiżi tal-koagulazzjoni (attività ta' fattur IX fil-plażma) hu indispensabbli.
English: A total of 249 bleeding episodes were treated with RIXUBIS, of which 197 were joint bleeds and 52 non-joint bleeds (soft tissue, muscle, body cavity, intracranial and other).
Maltese: Total ta' 249 episodju ta' ħruġ ta' demm ġew ikkurati b'RIXUBIS, li minnhom 197 kienu ħruġ ta' demm konġunt u 52 kienu ħruġ ta' demm mhux konġunt (tessut artab, muskoli, kavità tal-ġisem, intrakranjali u oħrajn).
English: If the product is stored in a refrigerator, take both the RIXUBIS powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 30°C).
Maltese: Jekk il-prodott ikun maħżun fi friġġ, ħu kemm it-trab RIXUBIS kif ukoll il-kunjetti bis-solvent minn ġol-friġġ u ħallihom jilħqu t-temperatura tal-kamra (bejn 15°C u 30°C).
English: Life-threatening haemorrhages.
Maltese: Uża s-soluzzjoni rikostitwita immedjatament.
English: RIXUBIS contains the active substance nonacog gamma and is a coagulation factor IX product.
Maltese: RIXUBIS fih is-sustanza attiva nonacog gamma u hu prodott ta' fattur IX.
English: Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Maltese: Emofilija B hi marda ereditarja tal-koagulazzjoni tad-demm marbuta mas-sess tal-persuna li tiġi kkawżata minn tnaqqis fil-livelli ta' fattur IX u tirriżulta fi ħruġ abbundanti ta' demm għal ġol-ġogi, muskoli jew organi interni, jew b'mod spontanju jew b'riżultat ta' trawma aċċidentali jew kirurġika.
English: After repeated treatment with human coagulation factor IX (rDNA) products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Maltese: Wara kura ripetuta bi prodotti li fihom fattur IX tal-koagulazzjoni umana (rDNA), il-pazjenti għandhom jiġu mmonitorjati għall-iżvilupp ta' antikorpi newtralizzanti (inibituri) li għandhom jiġu kkwantifikati f'Unitajiet Bethesda (BU) billi jintuża ttestjar bijoloġiku adattat.
English: The potency (IU) is determined using the European Pharmacopoeia one stage clotting assay.
Maltese: Il-potenza (IU) tiġi determinata bl-użu tal-assaġġ tat-tagħqid ta' stadju wieħed ta' Farmakopoeia Ewropea.
English: Kidney disorders (nephrotic syndrome) have been reported following high doses of Factor IX in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Maltese: Disturbi tal-kliewi (sindrome nefrotiku) ġie rrappurtat wara dożi għoljin ta' Fattur IX f'pazjenti b'emofilija B b'inibituri ta' fattur IX u storja ta' reazzjonijiet allerġiċi.
English: Dysgeusia
Maltese: L-Awstrija
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal- Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Maltese: Thrombin imbagħad jibdel fibrinogen f'fibrin u jinħoloq embolu.
English: RIXUBIS 1000 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Maltese: RIXUBIS 1000 IU trab u solvent għal soluzzjoni għall-injezzjoni nonacog gamma (fattur IX tal-koagulazzjoni umana rikombinanti)
English: RIXUBIS 250 IU powder and solvent for solution for injection RIXUBIS 500 IU powder and solvent for solution for injection RIXUBIS 1000 IU powder and solvent for solution for injection RIXUBIS 2000 IU powder and solvent for solution for injection RIXUBIS 3000 IU powder and solvent for solution for injection
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni RIXUBIS 1000 IU trab u solvent għal soluzzjoni għall-injezzjoni RIXUBIS 2000
English: Week 26 All (N=21)
Maltese: Ġimgħa 26 Kollha (N=21)
English: Repeat every 24 hours.
Maltese: Irrepeti kull 24 siegħa.
English: Incremental recovery 30 minutes after infusion was determined for all subjects in the combined phase 1/3 study at exposure day 1, at their week 5, 13, and 26 visits, and at the time of study completion or termination, if it did not coincide with the week 26 visit.
Maltese: L-irkuprar inkrementali 30 minuta wara l-infużjoni ġie determinat għall-individwi kollha fl-istudju kombinat ta' fażi 1/3 f'jum l tal-esponiment, fil-visti tagħhom ta' ġimgħa 5, 13, u 26, u fil-ħin meta tlesta jew intemm l-istudju, jekk ma kienx jikkoinċidi mal-vista ta' ġimgħa 26.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Maltese: Sindrome nefrotiku ġie rrappurtat wara attentat ta' induzzjoni ta' tolleranza immuni f'pazjenti b'emofilija B b'inibituri ta' fattur IX u storja ta' reazzjonijiet allerġiċi.
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, kura medika standard għal xokk għandha tiġi implimentata.
English: Stop your infusion and contact your doctor immediately or seek emergency medical care if you experience early signs of hypersensitivity/allergic reactions like hives, rash, tightness of the chest, wheezing, low blood pressure or anaphylaxis (severe allergic reaction that can cause difficulty in swallowing and/or breathing, red or swollen face and/or hands).
Maltese: Waqqaf l-infużjoni tiegħek u kkuntattja lit-tabib tiegħek immedjatament jew fittex kura medika ta' emerġenza jekk ikollok sinjali bikrija ta' sensittività eċċessiva/reazzjonijiet allerġiċi bħal ħorriqija, raxx, tagħfis tas-sider, tħarħir, pressjoni baxxa tad-demm jew anafilassi (reazzjoni allerġika severa li tista' tikkawża diffikultà biex tibla' u/jew biex tieħu n-nifs, wiċċ u/jew idejn minfuħin jew ħomor).
English: Area under the plasma concentration-time curve from time 0-72 hours post-infusion.
Maltese: Erja taħt il-kurva konċentrazzjoni-ħin 0-72 siegħa wara l-infużjoni.
English: Week 26 All (N=11)
Maltese: Ġimgħa 26 Kollha (N=11)
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Maltese: F'pazjenti b'fatturi ta' riskju kardjovaskulari eżistenti, it-terapija ta' sostituzzjoni b'FIX tista' żżid ir-riskju kardjovaskulari.
English: RIXUBIS 3000 IU powder and solvent for solution for injection One vial contains nominally 3000 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 600 IU/ml after reconstitution with 5 ml solvent.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Kunjett wieħed fih nominalment 3000 IU ta' nonacog gamma, fattur IX tal-koagulazzjoni umana rikombinanti (rDNA), li jikkorrispondu għal konċentrazzjoni ta' 600
English: Week 13 All (N=21)
Maltese: Ġimgħa 13 Kollha (N=21)
English: Factor IX level required (%) or (IU/dL)
Maltese: Livell ta' fattur IX meħtieġ (%) jew (IU/dL)
English: Week 26 All (N=10)
Maltese: Ġimgħa 26 Kollha (N=10)
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit factor IX per kg body weight raises the plasma factor IX activity by 0.9 IU/dL (range from 0.5 to 1.4 IU/dL) or 0.9% of normal activity in patients 12 years and older (further information see section 5.2).
Maltese: IU/dL) jew 0.9% tal-attività normali f'pazjenti li jkollhom 12-il sena u aktar (għal aktar informazzjoni ara sezzjoni 5.2).
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Maltese: Pazjenti b'emofilija B jistgħu jiżviluppaw antikorpi newtralizzanti (inibituri) għal fattur IX.
English: The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
Maltese: In-numru ta' unitajiet ta' fattur IX mogħtija hu espress f'Unitajiet Internazzjonali (IU), li huma relatati mal-istandard kurrenti tal-WHO għal prodotti ta' fattur IX.
English: One International Unit of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.
Maltese: Unità Internazzjonali waħda tal-attività ta' fattur IX hi ekwivalenti għal dik il-kwantità ta' fattur IX f'ml wieħed ta' plażma umana normali.
English: All 23 male subjects underwent an initial pharmacokinetic evaluation of RIXUBIS in a non-bleeding state as part of the combined phase 2/3 paediatric study.
Maltese: It-23 individwu rġiel kollha kellhom evalwazzjoni farmakokinetika inizjali ta' RIXUBIS fi stat li fih ma kellhomx ħruġ ta' demm, bħala parti mill-istudju pedjatriku kombinat ta' fażi 2/3.
English: A-2304 Orth an der Donau Austria
Maltese: A-2304
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor IX activity in patients' blood samples, plasma factor IX activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
Maltese: Minn aspett mikrobijoloġiku, ħlief jekk il-metodu tar-rikostituzzjoni jipprekludi r-riskju ta' kontaminazzjoni mikrobjali, il-prodott għandu jintuża immedjatament.
English: Week 13 All (N=10)
Maltese: Ġimgħa 13 Kollha (N=10)
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 tagħmir ta' aċċess ċentrali venuż (CVAD), ir-riskju ta' kumplikazzjonijiet relatati ma' CVAD li jinkludu infezzjonijiet lokali, batteremija u trombożi fis-sit tal-kateter, għandu jiġi kkunsidrat.
English: All (N=23)
Maltese: Kollha (N=23)
English: Grip the package at its edge and pull the package off BAXJECT II (Fig. b).
Maltese: Aqbad il-pakkett mit-tarf tiegħu u iġbed il-pakkettBAXJECT II (Fig. b).
English: Week 13 All (N=11)
Maltese: Ġimgħa 13 Kollha (N=11)
English: RIXUBIS was well tolerated in single dose and repeated dose toxicity studies conducted in mice, rats and cynomolgus monkeys up to doses of 7500 IU/kg (single dose) and 750 IU/kg (repeated application).
Maltese: RIXUBIS kien ittollerat tajjeb fi studji dwar it-tossiċità meta ngħatat doża waħda u dożi ripetuti, fi studji saru fuq il-ġrieden, firien u xadini cynomolgus, sa dożi ta' 7500
English: Median (range) Clearance (dL/(kg.hr)) Mean±SD
Maltese: Tneħħija (dL/(kg.hr)) Medja±SD Medjan (medda)
English: Calculated as (Cmax-baseline factor IX) divided by the dose in IU/kg, where Cmax is the maximal post-infusion factor IX measurement.
Maltese: Ikkalkulat bħala (Cmax-fattur IX fil-linja bażi) diviż bid-doża f'IU/kg, fejn C max hu l-kejl ta' fattur IX massimu wara l-infużjoni.