FrancophonIA/ELRC3.0 huggingface dataset:
English: The 30-day mortality rates were 16.2% (37/229) in patients presenting with ICH, 12.8% (12/94) with GI bleeding, and 17.9% (5/28) with other types of bleeding.
Maltese: Ir-rati ta' mortalità ta' 30 jum kienu 16.2% (37/229) f'pazjenti li kellhom ICH, 12.8% (12/94) bi ħruġ ta' demm gastrointestinali, u 17.9% (5/28) b'tipi oħra ta' ħruġ ta' demm.
English: Compared with patients recruited in North America, EU patients were significantly older (79.0 years vs. 76.3 years), more frequently had ICH as index event (72.9% vs. 59.0%) and more ICHs were intraparenchymal (54.9% vs. 34.4%).
Maltese: Meta mqabbla ma' pazjenti li ġew mill-Amerika ta' Fuq, il-pazjenti tal-UE kienu b'mod sinifikanti akbar fl-età (79.0 sena kontra 76.3 snin), kellhom ICH bħala avveniment indiċi b'mod aktar frekwenti (72.9% kontra 59.0%) u aktar ICHs kienu intraparenkimali (54.9% kontra 34.4%).
English: Plasma TFPI activity has been shown to be inhibited for 10 to 20 hours following andexanet alfa administration.
Maltese: Attività ta' TFPI fil-plażma ġiet murija li tiġi inibita għal 10 sa 20 siegħa wara li jingħata andexanet alfa.
English: Haemostatic efficacy was good or excellent in 81.9% of 249 patients.
Maltese: L-effikaċja emostatika kienet tajba jew eċċellenti f'81.9% minn 249 pazjent.
English: 400 mg at a target rate of 30 mg/min
Maltese: 400 mg f'doża fil-mira ta' 30 mg/min
English: Peripheral coldness common
Maltese: Kesħa periferali komuni
English: Reversal of anticoagulation in healthy subjects aged 50-75 (Studies 14-503 and 14-504) In a prospective, randomized, placebo-controlled study, healthy subjects with a median age of 56.5 years on apixaban 5 mg twice daily received andexanet alfa (n=24) administered as a 400 mg IV bolus immediately followed by a 4 mg per minute IV infusion for 120 minutes (480 mg) or placebo (n=8).
Maltese: Fi studju prospettiv, fejn il-pazjenti ntgħażlu b'mod każwali, ikkontrollat bil-plaċebo, individwi b'saħħithom b'età medjana ta' 56.5 snin fuq doża ta' apixaban 5 mg darbtejn kuljum irċivew andexanet alfa (n = 24) li ngħata bħala bolus ġol-vini ta' 400 mg segwit immedjatament minn infużjoni ġol-vini ta' 4 mg kull minuta għal 120 minuta (480 mg) jew plaċebo (n = 8).
English: The volume of distribution at steady state (Vdss) and volume of distribution (Vd) at sub-therapeutic levels decreased with dose, consistent with the saturation of a high-affinity compartment, likely to reflect binding to endothelial cell bound TFPI, the only endogenous molecule known to bind andexanet alfa.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss (Vdss, volume of distribution at steady state) u l-volum ta' distribuzzjoni (Vd, volume of distribution) f'livelli sottoterapewtiċi naqsu mad-doża, konsistenti massaturazzjoni ta' kompartiment b'affinità għolja, li x'aktarx jirrifletti l-irbit ma' TFPI marbuta ma' ċellola endoteljali, l-unika molekula endoġena magħrufa li torbot andexanet alfa.
English: Total number of 200 mg vials needed
Maltese: Numru totali ta' kunjetti ta' 200 mg meħtieġa
English: Among the rivaroxaban-treated subjects in Study 14-504, the percent change in anti-FXa activity was -96.72% (± 1.838%) for the andexanet alfa group and -44.75% (± 11.749%) for the placebo group (p < 0.0001 ), the latter reflecting the intrinsic clearance of the anticoagulant.
Maltese: 72% (± 1.838%) għall-grupp ta' andexanet alfa u -44.75% (± 11.749%) għall-grupp talplaċebo (p < 0.0001), tal-aħħar jirrifletti t-tneħħija intrinsika tal-antikoagulant.
English: PK comparability with andexanet alfa in Ondexxya (Generation 2) has not yet been proven.
Maltese: Il-komparabbilità tal-PK ma' andexanet alfa f'Ondexxya (Ġenerazzjoni 2) għadha ma ġietx ipprovata.
English: In both, Study 14-503 and Study 14-504, treatment with andexanet alfa also resulted in a statistically significant increase in thrombin generation in healthy subjects anticoagulated with apixaban or rivaroxaban versus placebo (p < 0.0001).
Maltese: Kemm fi Studju 14-503 kif ukoll fi Studju 14-504, it-trattament b'andexanet alfa rriżulta wkoll f'żieda statistikament sinifikanti fil-ġenerazzjoni tat-thrombin f'individwi b'saħħithom antikoagulati b'apixaban jew rivaroxaban kontra plaċebo (p < 0.0001).
English: 800 mg at a target rate of 30 mg/min
Maltese: 800 mg f'doża fil-mira ta' 30 mg/min
English: Each vial contains 200 mg of andexanet alfa*.
Maltese: Kull kunjett fih 200 mg ta' andexanet alfa*.
English: > 5 mg/ Unknown
Maltese: > 5 mg/ Mhux magħruf
English: After an appropriate number of vials of Ondexxya has been reconstituted, the reconstituted solution (10 mg/mL) is transferred to a suitable empty intravenous bag comprised of polyolefin (PO) or polyvinyl chloride (PVC) material without further dilution (see section 6.6) prior to administration by IV infusion using a 0.2 or 0.22 micron in-line polyethersulfone (PES) or equivalent low proteinbinding filter.
Maltese: Wara li numru adegwat ta' kunjetti ta' Ondexxya jiġu rikostitwiti, is-soluzzjoni rikostitwita (10 mg/mL) tiġi ttrasferita f'borża għall-użu għal ġol-vini vojta u adegwata li tkun magħmula minn materjal ta' polyolefin (PO) jew polyvinyl chloride (PVC) mingħajr aktar dilwizzjoni (ara sezzjoni 6.6) qabel l-għoti permezz ta' infużjoni ġol-vini (IV) bl-użu ta' filtru in-line talpolyethersulfone (PES) ta' 0.2 jew 0.22 micron jew filtru ekwivalenti b'livell baxx ta' rbit malproteini.
English: In addition, independent pro-thrombotic effect of andexanet alfa cannot be ruled out.
Maltese: Barra minn hekk, ma jistax jiġi eskluż l-effett protrombotiku indipendenti ta' andexanet alfa.
English: Limitations of use
Maltese: Limitazzjonijiet tal-użu
English: Treatment-emergent, non-neutralizing antibodies to andexanet alfa were detected in approximately 10% (35/345).
Maltese: Antikorpi għal andexanet alfa mhux newtralizzanti kkawżati mit-trattament kienu identifikati f'madwar 10% (35/345).
English: No trials have been conducted to investigate the pharmacokinetics of andexanet alfa in renally impaired patients.
Maltese: Ma twettqux provi biex tiġi investigata l-farmakokinetika ta' andexanet alfa f'pazjenti b'indeboliment renali.
English: Table 3: Summary of dosing for reversal of rivaroxaban
Maltese: Tabella 3: Sommarju tad-dożaġġ għat-treġġigħ lura ta' rivaroxaban
English: > 10 mg/ Unknown
Maltese: > 10 mg/ Mhux magħruf
English: Hypersensitivity to the active substance or to any other ingredients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: The second column provides the list of adverse reactions from the interim results of the Phase IIIb/IV ANNEXA-4 study, including 352 patients with acute major bleeding treated with andexanet alfa.
Maltese: IIIb/IV ANNEXA-4, li jinkludu 352 pazjent bi ħruġ tad-demm maġġuri akut ittrattati b'andexanet alfa.
English: Attach ancillary equipment (i.e., extension tubing, air filters, syringe driver) in preparation for administration.
Maltese: Waħħal apparat anċillari (jiġifieri, tubu tal-estensjoni, filtri tal-arja, driver tas-siringa) bħala preparazzjoni għall-għoti.
English: Andexanet alfa is a recombinant form of human FXa protein that has been modified to lack FXa enzymatic activity.
Maltese: Andexanet alfa huwa forma rikombinanti tal-proteina umana tal-FXa li ġiet immodifikata biex ma jkollhiex l-attività enzimatika ta' FXa.
English: Last dose
Maltese: Tqala u treddigħ
English: The 30-day mortality rates were 20.1% (44/219) in patients aged > 75 years old and 7.6% (10/132) in patients aged ≤ 75 years.
Maltese: 1% (44/219) għal pazjenti li kellhom > 75 sena, u 7.6% (10/132) għal pazjenti li kellhom ≤ 75 sena.
English: The effects of andexanet alfa can be measured through pharmacodynamic markers, including anti-FXa activity, and free fraction of available FXa inhibitor as well as through restoration of thrombin generation.
Maltese: L-effetti ta' andexanet alfa jistgħu jiġu mkejla permezz tal-markers farmakodinamiċi, li jinkludu attività anti-FXa u frazzjoni ħielsa ta' inibitur ta' FXa disponibbli, kif ukoll permezz tat-treġġigħ lura tal-ġenerazzjoni tat-thrombin.
English: In order to further confirm the posology of Ondexxya, the MAH should submit the results of a comparative PK study with Generation 1, process 3, and Generation 2 material (study 19-514).
Maltese: Sabiex tkompli tiġi kkonfermata l-pożoloġija ta' Ondexxya, l-MAH għandu jippreżenta r-riżultati ta' studju tal-PK komparattiv b'materjali ta' Ġenerazzjoni 1 proċess 3, u Ġenerazzjoni 2 (studju 19-514).
English: Andexanet alfa is to be reconstituted and the 10 mg/mL solution then transferred to a suitable IV bag comprised of polyolefin (PO) or polyvinyl chloride (PVC) material without further dilution prior to administration by IV infusion using a 0.2 or 0.22 micron in-line polyethersulfone (PES) or equivalent low protein-binding filter.
Maltese: Andexanet alfa għandu jiġi rikostitwit u mbagħad is-soluzzjoni rikostitwita ta' 10 mg/mL tiġi ttrasferita għal borża għal infużjoni ġol-vini adegwata li tkun magħmula minn materjal ta' polyolefin (PO) jew polyvinyl chloride (PVC) mingħajr aktar dilwizzjoni qabel l-għoti permezz ta' infużjoni ġolvini bl-użu ta' filtru in-line tal-polyethersulfone (PES) ta' 0.2 jew 0.22 micron jew filtru ekwivalenti b'livell baxx ta' rbit mal-proteini.
English: Reduction in anti-FXa activity correlates with restoration of thrombin generation.
Maltese: It-tnaqqis fl-attività anti-FXa jikkorrela mat-treġġigħ lura tal-ġenerazzjoni tat-thrombin.
English: FXa inhibitors did not affect andexanet alfa pharmacokinetics at therapeutic levels.
Maltese: L-inibituri ta' FXa m'affettwawx il-farmakokinetika ta' andexanet alfa f'livelli terapewtiċi.
English: After treatment with Ondexxya, your doctor will decide when to restart anticoagulant therapy.
Maltese: Wara t-trattament b'Ondexxya, it-tabib tiegħek se jiddeċiedi meta għandha terġa' tinbeda t-terapija antikoagulanti.
English: Table 4 provides the list of adverse reactions from clinical studies of healthy subjects treated with andexanet alfa.
Maltese: Tabella 4 tipprovdi lista ta' reazzjonijiet avversi minn provi kliniċi li saru fuq individwi b'saħħithom ittrattati b'andexanet alfa.
English: No thromboembolic events were observed in 223 healthy volunteers who received FXa inhibitors and were treated with andexanet alfa.
Maltese: Ma kienu osservati l-ebda avvenimenti tromboemboliċi fil-223 voluntiera b'saħħithom li rċivew inibituri ta' FXa u kienu ttrattati b'andexanet alfa.
English: Pharmacotherapeutic group: All other therapeutic products, antidotes.
Maltese: Kull prodott terapewtiku ieħor, antidoti.
English: Administration of andexanet alfa as a bolus followed by continuous infusion resulted in a sustained decrease in anti-FXa activity.
Maltese: L-għoti ta' andexanet alfa bħala bolus segwit minn infużjoni kontinwa rriżulta fi tnaqqis sostnut fl-attività anti-FXa.
English: Reversing the effect of a factor Xa inhibitor with Ondexxya may increase the risk of blood clots.
Maltese: Ladarba jiġi rikostitwit, Ondexxya hu intenzjonat għal użu immedjat.
English: Reversal of apixaban
Maltese: Popolazzjoni pedjatrika
English: The primary endpoint for both Study 14-503 (apixaban) and Study 14-504 (rivaroxaban) was the percent change in anti-FXa activity from baseline to post-infusion nadir.
Maltese: Il-punt ta' tmiem primarju kemm għal Studju 14-503 (apixaban) u għal Studju 14-504 (rivaroxaban) kien il-bidla perċentwali fl-attività anti-FXa mil-linja bażi għall-punt l-aktar baxx ta' wara l-infużjoni.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Infart ċerebrali mhux komuni
English: Antithrombotic therapy can be re-initiated as soon as medically indicated following treatment if the patient is clinically stable and adequate haemostasis has been achieved.
Maltese: It-terapija antitrombotika tista' terġa' tinbeda hekk kif jiġi indikat medikament wara t-trattament jekk il-pazjent ikun klinikament stabbli u tkun inkisbet emostasi adegwata.
English: Vial (unopened) Two years stored at 2°C to 8°C.
Maltese: Kunjett (mhux miftuħ) Sentejn maħżun f'temperatura ta' 2 °C sa 8 °C.
English: Each vial contains 200 mg of andexanet alfa.
Maltese: Kull kunjett fih 200 mg ta' andexanet alfa.
English: FXa inhibitor
Maltese: Tmiem tal-Infużjoni
English: Reversal of the effects of other FXa inhibitors (e.g., fondaparinux, unfractionated heparin) with andexanet alfa has not been studied in humans.
Maltese: It-treġġigħ lura tal-effetti ta' inibituri ta' FXa oħra (eż., fondaparinux, eparina mhux frazzjonata) b'andexanet alfa ma ġiex studjat fil-bnedmin.
English: Laboratory parameters as antiFXa activity, endogenous thrombotic potential (ETP), or markers of thrombosis might not be reliable for guidance.
Maltese: Il-parametri tal-laboratorju bħal attività anti-FXa, potenzjal trombotiku endoġenu
English: Change from baseline in free FXa inhibitor concentration at nadir The mean unbound concentrations of apixaban and rivaroxaban were < 3.5 ng/mL and 4 ng/mL, respectively, after bolus andexanet alfa administration and were maintained throughout the continuous infusion.
Maltese: Bidla mil-linja bażi fil-konċentrazzjoni ta' inibituri ta' FXa ħielsa fl-aktar punt baxx Il-konċentrazzjonijiet medji mhux marbuta ta' apixaban u rivaroxaban kienu ta' < 3.5 ng/mL u 4 ng/mL, rispettivament, wara għoti ta' andexanet alfa permezz ta' bolus u kienu sostnuti matul linfużjoni kontinwa kollha.
English: The two co-primary endpoints are: a) percent change in anti-FXa activity from baseline to the nadir between five minutes after the end of the bolus until the end of the infusion, and; b) rate of good or excellent (compared to poor or none) haemostatic efficacy within 12 hours after infusion, as rated by an independent endpoint adjudication committee .
Maltese: Iż-żewġ punti ta' tmiem ko-primarji huma: a) bidla perċentwali fl-attività anti-FXa mil-linja bażi għall-aktar punt baxx bejn ħames minuti wara t-tmiem tal-bolus sa meta tintemm l-infużjoni, u; b) ir-rata ta' effikaċja emostatika tajba jew eċċellenti (imqabbla ma' baxxa jew l-ebda) fi żmien 12il siegħa wara l-infużjoni, kif ikklassifikata minn kumitat tal-aġġudikazzjoni tal-punt tat-tmiem indipendenti.
English: No dose-limiting toxicities have been observed during clinical trials.
Maltese: L­ebda tossiċità li tillimita d­doża ma ġiet osservata matul il-provi kliniċi.
English: Ten of 36 (27.8%) patients had restarted antithrombotic therapy at the time of the event, and all 36 patients had been anticoagulated for a prior history of VTE and/or atrial fibrillation at the time of receiving andexanet alfa (see sections 4.4 and 5.1).
Maltese: Għaxra mis36 (27.8%) pazjent kienu reġgħu bdew it-terapija kontra t-trombożi fl-istess żmien tal-avveniment, u s-36 pazjent kollha kienu ġew antikoagulati għal storja medika preċedenti ta' VTE u/jew fibrillazzjoni atrijali fiż-żmien li kienu qed jirċievu andexanet alfa (ara sezzjonijiet 4.4 u 5.1).
English: Reversal of FXa inhibitor anticoagulation in patients with acute major bleeding In Study 14-505 (ANNEXA-4), a Phase IIIb/IV multinational, prospective, single-arm, open-label study, Ondexxya was administered to 352 patients on FXa inhibitors who presented with acute major bleeding.
Maltese: IIIb/IV, multinazzjonali, prospettiv, ta' fergħa waħda u openlabel, Ondexxya ngħata lil 352 pazjent li kienu fuq inibituri ta' FXa li kellhom ħruġ ta' demm akut maġġuri.
English: DO NOT SHAKE the vials, as this can lead to foaming.
Maltese: Mhux se jreġġa' lura l-effetti ta' inibituri mhux FXa.
English: Phase II studies of andexanet alfa in the presence of direct FXa inhibitors demonstrated the same dose proportional pharmacokinetics over the intended therapeutic dose range evaluated for both Cmax and area under the curve (AUC) with an effective half-life of approximately one hour.
Maltese: II ta' andexanet alfa fil-preżenza ta' inibituri diretti ta' FXa wrew l-istess farmakokinetika proporzjonali għad-doża fuq il-medda tad-doża terapewtika intenzjonata evalwata għal kemm is-Cmax u l-erja taħt il-kurva (AUC, area under the curve) b'half-life effettiva ta' madwar siegħa.
English: The time courses of anti-FXa activity before and after andexanet alfa administration are shown in Figure 1.
Maltese: Il-perjodi ta' ħin tal-attività anti-FXa qabel u wara l-għoti ta' andexanet alfa huma murija f'Figura 1.
English: Abdominal discomfort common
Maltese: Disturbi gastro-intestinali Skonfort addominali komuni
English: • The other ingredients are Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose,
Maltese: - Is-sustanzi mhux attivi l-oħra huma Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose, mannitol, u polysorbate 80.
English: Reconstituted medicinal product
Maltese: IL-PRODOTT MEDIĊINALI
English: The European Medicines Agency has deferred the obligation to submit the results of studies with andexanet alfa in one or more subsets of the paediatric population in treatment and prevention of FXa inhibitor-associated haemorrhages (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'andexanet alfa f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fit-trattament u l-prevenzjoni ta' emorraġiji assoċjati mal-inibitur ta' FXa (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: • muscle spasms
Maltese: Tmiem tal-Bolus
English: Use andexanet alfa within eight hours after reconstitution when stored at room temperature.
Maltese: Uża andexanet alfa fi żmien tmien sigħat wara r-rikostituzzjoni meta jkun maħżun f'temperatura tal-kamra.
English: Iliac artery occlusion uncommon
Maltese: Okklużjoni tal-arterja ilijaka mhux komuni
English: Andexanet alfa binds direct FXa inhibitors with high affinity, making them unavailable to exert their anticoagulant effects.
Maltese: Andexanet alfa jorbot inibituri ta' FXa diretti b'affinità għolja, u b'hekk ma jibqgħux jeżerċitaw l-effetti antikoagulanti tagħhom.
English: Musculoskeletal and connective tissue disorders
Maltese: Spażmi tal-muskoli komuni
English: Package Leaflet: Information for the patient and user Ondexxya 200 mg powder for solution for infusion andexanet alfa
Maltese: Informazzjoni għall-pazjent u għall-utent Ondexxya 200 mg trab għal soluzzjoni għall-infużjoni andexanet alfa
English: 297/352 patients (84.4%) received the low-dose regimen of andexanet, while 55 patients (15.6%) received the high-dose regimen.
Maltese: 7%). 297/352 pazjent (84.4%) irċivew kors ta' doża baxxa ta' andexanet, filwaqt li 55 pazjent (15.
English: Muscle spasms common
Maltese: Skumdità fis-sider komuni
English: Biliary and/or faeces elimination of protein therapeutics is not a known route of protein elimination.
Maltese: L-eliminazzjoni biljari u/jew fl-ippurgar tat-terapewtiċi tal-proteini mhix rotta magħrufa għall-eliminazzjoni tal-proteini.
English: Administration using a syringe pump
Maltese: L-għoti bl-użu ta' pompa tas-siringa
English: In order to further substantiate correlation of the biomarker (antiFXa-activity) with haemostatic efficacy and clarify the risk of thromboses and thromboembolic events, the MAH should submit the results of ANNEXA-4, an interventional non-randomized, multicentre, prospective, open-label, single-group study in patients with acute major bleeding.
Maltese: Sabiex tkompli tiġi ssostanzjata l-korrelazzjoni tal-bijomarkatur (attività antiFXa) maleffikaċja emostatika u jiġi ċċarat ir-riskju ta' trombożi u ta' avvenimenti tromboemboliċi, l-MAH għandu jippreżenta r-riżultati ta' ANNEXA-4, studju intervenzjonali, fejn il-pazjenti ma ntgħażlux b'mod każwali, multi-ċentriku, prospettiv, open-label, bi grupp wieħed f'pazjenti bi ħruġ ta' demm maġġuri akut.
English: Attach ancillary equipment (i.e., extension tubing, air filters, IV pump) in preparation for administration.
Maltese: Waħħal apparat anċillari (jiġifieri, tubu tal-estensjoni, filtri tal-arja, pompa għall-użu għal ġolvini) bħala preparazzjoni għall-għoti.
English: Low dose
Maltese: Doża baxxa
English: Ondexxya is administered as an IV bolus at a target rate of approximately 30 mg/min over 15 to 30 minutes, followed by administration of a continuous infusion of 4 mg (low dose) or 8 mg (high dose) per minute for 120 minutes (see table 1).
Maltese: Ondexxya jingħata bħala bolus ġol-vini (IV) b'rata fil-mira ta' madwar 30 mg/min għal 15 sa 30 minuta, segwita minn għoti ta' infużjoni kontinwa ta' 4 mg (doża baxxa) jew 8 mg (doża għolja) kull minuta għal 120 minuta (ara tabella 1).
English: The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin, and the gamma-carboxyglutamic acid (Gla) domain was removed to eliminate the ability of the protein to assemble into the prothrombinase complex, thus removing any anti-coagulant effects.
Maltese: Is-sit attiv serine ġie issostitwit b'alanine, u b'hekk il-molekula ma setgħetx tifred u tattiva l-protrombina, u d-dominju tal-gamma-carboxyglutamic acid (Gla) ġie mneħħi biex tiġi eliminata l-abilità tal-proteina li tingħaqad fil-kumpess tal-prothrombinase, u b'hekk jitneħħew kwalunkwe effetti antikoagulanti.
English: Andexanet alfa is administered as an intravenous bolus at a target rate of approximately 30 mg/min over 15 minutes (low dose) or 30 minutes (high dose), followed by administration of a continuous infusion of 4 mg/min (low dose) or 8 mg/min (high dose) for 120 minutes (see table 1).
Maltese: Andexanet alfa jingħata bħala bolus ġol-vini b'rata fil-mira ta' madwar 30 mg/min għal 15-il minuta (doża baxxa) jew 30 minuta (doża għolja), segwita minn għoti ta' infużjoni kontinwa ta' 4 mg/min (doża baxxa) jew 8 mg/min (doża għolja) għal 120 minuta (ara tabella 1).
English: Use aseptic technique during the reconstitution procedure.
Maltese: Uża teknika axxettika matul il-proċedura tar-rikostituzzjoni.
English: The maximal reversal of anti-FXa activity was achieved within two minutes of completing the bolus administration.
Maltese: It-treġġigħ lura massimu ta' attività anti-FXa inkiseb fi żmien żewġ minuti wara li l-għoti tal-bolus tlesta.
English: Submission of the final CSR by 30
Maltese: Sottomissjoni tas-CSR finali sat-30 ta' Settembru
English: Dose-dependent increases in coagulation markers F1+2, TAT, and D-dimers after administration of andexanet alfa were observed, but these markers were not measured in patients enrolled in the ANNEXA-4 study, and their relevance in bleeding patients is not known.
Maltese: Kienu osservati żidiet dipendenti fuq id-doża filmarkers tal-koagulazzjoni F1+2, TAT u D-dimers wara l-għoti ta' andexanet alfa, iżda dawn ilmarkers ma kinux imkejla f'pazjenti rreġistrati fl-istudju ANNEXA-4, u r-rilevanza tagħhom f'pazjenti bi ħruġ ta' demm mhix magħrufa.
English: Gastrointestinal disorders
Maltese: Il-prodott mediċinali rikostitwit
English: For these patients, median anti-FXa activity at baseline was 149.7 ng/mL for patients taking apixaban, and 211.8 ng/mL for patients taking rivaroxaban.
Maltese: Għal dawn ilpazjenti, l-attività medjana ta' anti-FXa fil-linja bażi kienet ta' 149.7 ng/mL għal pazjenti li kienu qed jieħdu apixaban, u 211.
English: • Same number of 20 mL (or larger) solvent syringes equipped with a 20 gauge (or larger) needle.
Maltese: • L-istess numru ta' siringi tas-solvent ta' 20 mL (jew akbar) mgħammra b'labra ta' gauge ta' 20 (jew akbar).
English: Ischaemic stroke common
Maltese: .8 Effetti mhux mixtieqa
English: What Ondexxya looks like and contents of the pack
Maltese: Kif jidher Ondexxya u l-kontenut tal-pakkett
English: • Intravenous PO or PVC bag (150 mL or larger) to contain the final volume of reconstituted product (if administration is performed with an IV bag).
Maltese: • Borża għall-użu għal ġol-vini tal-PO jew PVC (150 mL jew akbar) biex iżżomm il-volum finali tal-prodott rikostitwit (jekk tuża borża għall-użu għal ġol-vini għall-għoti).
English: Patients being treated with FXa inhibitor therapy have underlying disease states that predispose them to thromboembolic events.
Maltese: Il-pazjenti ttrattati b'terapija tal-inibitur FXa għandhom stati tal-mard sottostanti li jippredisponuhom għal avvenimenti tromboemboliċi.