FrancophonIA/ELRC3.0 huggingface dataset:
English: Consequently the use of altrenogest in mares is not considered to pose a risk to the environment when used as specified in the SPCs given the minimal environmental exposure associated with this use, and the environmental risk assessment presented below is based on the use of altrenogest in gilts.
Maltese: Konsegwentement, l-użu ta' altrenogest fid-dwieb mhuwiex ikkunsidrat li jkun ta' riskju għall-ambjent meta użat kif speċifikat fl-SPCs minħabba lesponiment ambjentali minimu assoċjat ma' dan l-użu, u l-valutazzjoni tar-riskju ambjentali ppreżentata hawn taħt hija bbażata fuq l-użu ta' altrenogest fil-qżieqeż nisa żgħar.
English: Risk mitigation measures
Maltese: Miżuri ta' mitigazzjoni tar-riskji
English: The environmental risk assessment is focused on the risk to the environment as a result of the zootechnical use of veterinary medicinal products containing altrenogest in gilts.
Maltese: Il-valutazzjoni tar-riskju ambjentali hija ffokata fuq ir-riskju għall-ambjent bħala riżultat tal-użu żootekniku tal-prodotti mediċinali veterinarji li fihom altrenogest fil-qżieqeż nisa żgħar.
English: EU/1/07/416/002 Ecalta
Maltese: EU/1/07/416/002
English: 100 mg Powder for concentrate for solution for infusion
Maltese: 100 mg Tab għal konċentrat għal soluzzjoni għallinfużjoni
English: MA (EU) number Name Strength Pharmaceutical Form
Maltese: Numru tal-MA (EU) Isem (inventat) Qawwa Għamla farmaċewtika
English: Pack size
Maltese: Ecalta
English: Intravenous use vial (glass)
Maltese: Kunjett (ħġieġ)
English: EU Number
Maltese: Numru ta' EU
English: (Invented) name
Maltese: (Ivvintat) Isem
English: Intravenous use vial (glass)
Maltese: Użu għal ġol-vini kunjett (talħġieġ)
English: European Medicines Agency Veterinary Medicines
Maltese: European Medicines Agency
English: EMEA/V/C/157
Maltese: EMEA/V/C/157 RAPPORT TA' VALUTAZZJONI
English: Zero days
Maltese: L
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) GRIPOVAC 3 EPAR summary for the public
Maltese: PUBBLIKA EWROPEW (EPAR) GRIPOVAC 3 Sommarju tal-EPAR għall-pubbliku
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Gripovac 3 exceed the risks for the vaccination of pigs from the age of 56 days onwards inluding pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection and recommended that Gripovac 3 be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Gripovac 3 huma akbar mir-riskji għat-tilqim ta' ħnieżer mill-età ta' 56 ġurnata 'il quddiem inkluż fil-każ ta' ħnieżer nisa tqal kontra l-influwenza tal-ħnieżer ikkawżata minn sottotipi H1N1, H3N2 u H1N2, biex inaqqas is-sinjali kliniċi u l-ammont ta' virus fil-pulmun wara infezzjoni u rrakkomanda li Gripovac 3 jingħata awtorizzazzjoni għal tqegħid fis-suq.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il bilanċ bejn il-benefiċċju-riskju jista' jinstab fil-modulu 6 ta' dan l-EPAR.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: Gripovac 3 is a suspension for injection.
Maltese: Gripovac 3 huwa sospensjoni għall-injezzjoni.
English: Gripovac 3 is a vaccine that contains 3 different strains of swine influenza A virus which have been inactivated (killed).
Maltese: Gripovac 3 huwa vaċċin li fih 3 razez differenti tal-virus tal-influwenza A tal-ħnieżer li kienu ġew inattivati (maqtula).
English: What is Gripovac 3?
Maltese: X'inhu Gripovac 3?
English: Gripovac 3 is a vaccine.
Maltese: Gripovac 3 huwa vaċċin.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Gripovac 3 to Merial on 14.01.2010.
Maltese: Informazzjoni oħra dwar Gripovac 3: Il-Kummissjoni Ewropea tat awtorizzazzjoni għal tqegħid fis-suq valida mal-Unjoni Ewropea kollha, għal Gripovac 3 lil Merial fil-14.01.2010.
English: Why has Gripovac 3 been approved?
Maltese: Għaliex ġie approvat Gripovac 3?
English: This protects the pigs against the disease.
Maltese: Dan jipproteġi l-ħnieżer kontra l-marda.
English: Gripovac 3 contains small amounts of a modified and then killed form of the pig's influenza virus that causes lesions and illness.
Maltese: Gripovac 3 fih ammonti żgħar ta' forma modifikata u mbagħad maqtula tal-virus tal-influwenza tal-ħnieżer li jista' jikkawża feriti u mard.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi ‘jgħallmu' lis-sistema immuni (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra marda.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: Informazzjoni dwar l-istatus talpreskrizzjoni ta' dan il-prodott tinsab fuq it-tikketta/il-pakkett ta' barra.
English: The effectiveness of Gripovac 3 has been studied in animals 56 days of age and older and in sows before and during pregnancy and these studies document that the vaccine protects against swine influenza.
Maltese: Kif ġie studjat Gripovac 3? L-effikaċja ta' Gripovac 3 ġiet studjata f'annimali ta' 56 ġurnata jew akbar u fi ħnieżer nisa qabel u wara t-tqala u dawn l-istudji jiddokumentaw li l-vaċċin jipproteġi kontra l-influwenza tal-ħnieżer.
English: Use of the Gripovac 3 in pigs reduces clinical signs and reduces the amount of virus in the lungs after infection caused by swine influenza A virus.
Maltese: L-użu ta' Gripovac 3 fil-ħnieżer inaqqas is-sinjali kliniċi u jnaqqas l-ammont tal-virus fil pulmuni wara l-infezzjoni kkawżata mill-virus tal-influwenza A tal-ħnieżer.
English: What is the risk associated with Gripovac 3?
Maltese: X'inhu r-riskju assoċjat ma' Gripovac 3?
English: Other information about Gripovac 3:
Maltese: Kif jaħdem Gripovac 3?
English: Gripovac 3 is used to vaccinate pigs including pregnant sows over the age of 56 days against swine influenza in order to help them clinically but also to reduce the amount of virus present in the lungs.
Maltese: Gripovac 3 jintuża għat-tlaqqim ta' ħnieżer inklużi l-ħnieżer nisa tqal ta' iktar minn 56 ġurnata kontra l-influwenza tal-majjali biex jiġu mgħejunin klinikiament iżda wkoll biex jitnaqqas lammont tal-virus preżenti fil-pulmuni.
English: How does Gripovac 3 work?
Maltese: Liema benefiċċju wera Gripovac 3 waqt l-istudji?
English: Oral use Oral use Oral use Oral use blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu)
Maltese: Użu orali Użu orali Użu orali Użu orali folja (OPA/alu/PVC/alu) folja (OPA/alu/PVC/alu) folja (OPA/alu/PVC/alu) folja (OPA/alu/PVC/alu)
English: 84 tablets 10 tablets 30 tablets 100 tablets
Maltese: 84 pilloli 10 pilloli 30 pilloli 100 pilloli
English: Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Maltese: Pillola miksija b'rita Pillola miksija b'rita Pillola miksija b'rita Pillola miksija b'rita
English: ATC code: V03AB38
Maltese: Kodiċi ATC: V03AB38
English: Portola Netherlands B.V. Prins Bernhardplein 200 1097 JB Amsterdam Netherlands
Maltese: Portola Netherlands B.V. Prins Bernhardplein 200 1097 JB Amsterdam in-Netherlands
English: System organ class/ Preferred term
Maltese: Sistema tal-klassifika tal-organi/ Terminu ppreferut
English: PK/PD modelling
Maltese: Mudellar PK/PD
English: • Calculated number of vials as given in table 1.
Maltese: • Numru kkalkulat ta' kunjetti kif ipprovdut f'tabella 1.
English: 8 mg/min for 120 minutes (960 mg)
Maltese: 8 mg/min għal 120 minuta (960 mg)
English: Name and address of the manufacturer of the biological active substance Lonza Biologics Porrino, S.L.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Lonza Biologics Porrino, S.L.
English: • Calculated number of vials (see section 4.2).
Maltese: • Numru kkalkulat ta' kunjetti (ara sezzjoni 4.2).
English: 4 mg/min for 120 minutes (480 mg)
Maltese: 4 mg/min għal 120 minuta (480 mg)
English: Reduction in anti-FXa activity
Maltese: Tnaqqis fl-attività anti-FXa
English: Administration using a syringe pump 1.
Maltese: L-għoti bl-użu ta' pompa tas-siringa 1.
English: Diphenhydramine may be administered.
Maltese: Jista' jingħata diphenhydramine.
English: Excipients: Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose, mannitol, polysorbate 80
Maltese: Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose, mannitol, polysorbate 80
English: Thrombotic events have been reported following treatment with andexanet alfa (see sections 4.8 and 5.1).
Maltese: Ġew irrappurtati avvenimenti trombotiċi wara t-trattament b'andexanet alfa (ara sezzjonijiet 4.8 u 5.1).
English: In the ANNEXA-4 study, 36 (10.3%) patients experienced a total of 42 thromboembolic events: cerebrovascular accident (CVA) (15/42; 35.7%), deep venous thrombosis (13/42; 33.1%), acute myocardial infarction (8/42; 19.0%), pulmonary embolism (5/42; 11.9%), and transient ischaemic attack (1/42; 2.4%).
Maltese: Fl-istudju ANNEXA-4 36 (10.3%) pazjent kellhom total ta' 42 avveniment tromboemboliku: aċċident ċerebrovaskulari (CVA, cerebrovascular accident) (15/42; 35.7 %), trombożi tal-vini profondi (13/42; 33.1%), infart mijokardiku akut (8/42; 19.0%); emboliżmu pulmonari (5/42; 11.9%) u attakk iskemiku temporanju (1/42; 2.4%).
English: Date of first authorisation: 26 April 2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26 t'April 2019
English: List of possible side effects
Maltese: Lista ta' effetti sekondarji possibbli
English: Transient elevations of D-dimer and F1+2 fragments very common
Maltese: Investigazzjonijiet Żidiet temporanji fil-livelli tal-frammenti D-dimer u F1+2 komuni ħafna
English: * Andexanet alfa is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
Maltese: *Andexanet alfa huwa magħmul minn teknoloġija ta' DNA rikombinanti f'ċelluli tal-Ovarju talĦamster Ċiniż (CHO, Chinese Hamster Ovary).
English: Thromboembolic events
Maltese: Avvenimenti trombo-emboliċi
English: Continuous intravenous infusion
Maltese: Infużjoni ġol-vini kontinwa
English: The adverse reactions are classified by system organ class (SOC) and frequency, using 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); or not known (cannot be estimated from available data).
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont is-Sistema tal-Klassifika tal-Organi (SOC) u l-frekwenza, bl-użu tal-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); u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Table 1: Dosing regimens
Maltese: Tabella 1: Korsijiet tad-dożaġġ
English: Change in anti-FXa activity (ng/mL) in healthy subjects anticoagulated with apixaban (A) and rivaroxaban (B)
Maltese: Bidla f'attività anti-FXa (ng/mL) f'individwi b'saħħithom antikoagulati b'apixaban (A) u rivaroxaban (B)
English: Non-cardiovascular deaths (n=27) included: respiratory failure (n=5), infection/sepsis (n=5), accident/trauma (n=2), cancer (n=1), and other/non-vascular cause (n=14).
Maltese: Imwiet mhux kardjovaskulari (n = 27) kienu jinkludu: falliment respiratorju (n = 5), infezzjoni/sepsi (n = 5), aċċident/trawma (n = 2), kanċer (n = 1), u kawża oħra/mhux vaskulari (n = 14).
English: Ondexxya contains the active ingredient andexanet alfa.
Maltese: Ondexxya fih is-sustanza attiva andexanet alfa.
English: In ANNEXA-4, intracranial haemorrhage (ICH) patients (GCS > 7 and haematoma volume < 60 mL) have been included.
Maltese: Il-pazjenti b'emorraġija intrakranjali (ICH, Intracranial Haemorrhage) (GCS > 7 u volum tal-ematoma < 60 mL) ġew inklużi fl-ANNEXA-4.
English: Thirty-six of 352 patients with complete 30-day safety follow up (10.3%) had thrombotic events, including venous thromboembolism (VTE), myocardial infarction (MI), and stroke.
Maltese: Sitta u tletin mit-352 pazjent b'segwitu għas-sigurtà komplet ta' 30 jum (10.3%) kellhom avvenimenti trombotiċi, inkluż tromboemboliżmu ġol-vini (VTE, venous thromboembolism), infart mijokardijaku (MI, myocardial infarction), u puplesija.
English: • Alcohol swabs.
Maltese: • Tajjar bl-alkoħol.
English: Palpitations common
Maltese: Palpitazzjonijiet komuni
English: Initial intravenous bolus
Maltese: Bolus ġol-vini inizjali
English: In an updated interim analysis, data of 352 patients were evaluated.
Maltese: F'analiżi interim aġġornata, id-data ta' 352 pazjent ġiet evalwata.
English: At the time of the event 10/36 (27.8%) patients were on antithrombotic therapy.
Maltese: Fiż-żmien meta seħħ l-avveniment 10/36 (27.8%) pazjenti kienu fuq terapija antitrombotika.
English: Powder for solution for infusion 4 x 1 vial of 200 mg
Maltese: U KONTENUT Trab għal soluzzjoni għall-infużjoni 4 x 1 kunjett ta' 200 mg
English: Pulmonary embolism uncommon
Maltese: Emboliżmu pulmonari mhux komuni
English: • dry mouth
Maltese: Sess tal-persuna
English: Most patients had previously received either apixaban (194/352; 55.1%) or rivaroxaban (128/352; 36.4%), and experienced either an ICH (230/352; 65.3%) or a gastrointestinal (GI) bleed (94/352; 26.7%).
Maltese: Il-maġġoranza tal-pazjenti kienu rċivew minn qabel apixaban (194/352; 55.1%) jew rivaroxaban (128/352; 36.4%), u kellhom ICH (intracranial haemorrhage) (230/352; 65.3%) jew ħruġ ta' demm gastrointestinali (GI) (94/352; 26.
English: The antiFXa activity thresholds for normalization of thrombin generation (defined by mean ETP and standard deviations) were estimated to be 44.2 ng/mL (within one standard deviation of normal ETP) based on pooled data from Studies 14-503 and 14-504, as indicated in the figure.
Maltese: Illimiti tal-attività anti-FXa għan-normalizzazzjoni tal-ġenerazzjoni tat-thrombina (definiti permezz ta' ETP medju u devjazzjonijiet standard) kienu stmati li kienu 44.2 ng/mL (fi ħdan devjazzjoni standard waħda ta' ETP normali) abbażi ta' data miġbura minn Studji 14-503 u 14-504, kif indikat fil-figura.
English: ≥ 8 hours
Maltese: ≥ 8 sigħat
English: In the ANNEXA-4 study, of the patients in the safety population completing 30-day follow up (N=351), 54 patients (15.4%) died.
Maltese: Fl-istudju ANNEXA-4, mill-pazjenti fil-popolazzjoni ta' sigurtà li lestew is-segwitu ta' 30 jum (N = 351), 54 pazjent (15.4%) mietu.
English: Other medicines and Ondexxya
Maltese: Mediċini oħra u Ondexxya
English: Ondexxya 200 mg powder for solution for infusion andexanet alfa
Maltese: Ondexxya 200 mg trab għal soluzzjoni għall-infużjoni andexanet alfa
English: Clearance (L/hr) for andexanet alfa is 4.4 ± 1.2 L/hr with low renal elimination.
Maltese: It-tneħħija (L/siegħa) għal andexanet alfa hija ta' madwar 4.4 ± 1.2 L/siegħa b'eliminazzjoni renali baxxa.
English: Pack size of four vials.
Maltese: Kull pakkett fih erba' kunjetti.
English: A total of 33.3% of patients with thromboembolic events (12/36) experienced the thromboembolic event during the first three days.
Maltese: Total ta' 33.3% talpazjenti b'avvenimenti tromboemboliċi (12/36) kellhom l-avveniment tromboemboliku matul l-ewwel tlett ijiem.
English: Cardiovascular causes of death (n=27) included: haemorrhagic stroke (n=6), ischaemic stroke (n=5), sudden cardiac death (including unwitnessed) (n=5), cardiomechanical/pump failure (n=4), myocardial infarction (n=2), bleeding other than haemorrhagic stroke (n=1), and other cardiovascular causes (n=4).
Maltese: Kawżi kardjovaskulari ta' mewt (n = 27) kienu jinkludu: puplesija bl-emorraġija (n = 6), puplesija iskemika (n = 5), mewt kardijaka għal għarrieda (inklużi dawk li ma kienx hemm xhieda) (n = 5), falliment kardjomekkaniku/tal-pompa (n = 4), infart mijokardiku (n = 2), ħruġ ta' demm apparti l-puplesija blemorraġija (n = 1), u kawżi kardjovaskulari oħra (n = 4).
English: Distribution The Vd for andexanet alfa is 5.3 ± 2.6 L, approximately equivalent to the blood volume.
Maltese: Distribuzzjoni Il-Vd għal andexanet alfa huwa 5.3 ± 2.6 L, bejn wieħed u ieħor ekwivalenti għal volum tad-demm.
English: In order to further confirm the efficacy and safety, the MAH should submit an updated PK/PD model using all previously incorporated data (from studies 11-501, 12-502, 14503, 14-504, and 14-506) as well as newly incorporated data from study 16-512 (PKPD study of Generation 2 andexanet versus Generation 1), study 16-508 (PK-PD study of andexanet in individuals of Japanese ethnicity), and study 14-505 (ANNEXA-4).
Maltese: Sabiex ikomplu jiġu kkonfermati l-effikaċja u s-sigurtà, l-MAH għandu jippreżenta mudell tal-PK/PD aġġornat bl-użu tad-data kollha inkorporata preċedentament (minn studji 11-501, 12-502, 14-503, 14-504, u 14-506) kif ukoll data inkorporata mill-ġdid għal studju 16-512 (studju tal-PK-PD ta' andexanet tal-Ġenerazzjoni 2 kontra Ġenerazzjoni 1), studju 16-508 (studju tal-PK-PD ta' andexanet f'individwi ta' etniċità Ġappuniża), u studju 14-505 (ANNEXA-4).
English: Median change from baseline to nadir in anti-FXa activity was -93.4% (95% CI -94.3%, -92.4%) for apixaban, and -92.5% (95% CI -94.2%, -90.3%) for rivaroxaban.
Maltese: Il-bidla medjana mil-linja bażi għall-aktar punt baxx fl-attività anti-FXa kienet ta' -93.4% (95% CI -94.3%, -92.4%) għal apixaban, u -92.5% (95% CI -94.2%, -90.
English: Of the 209 patients who were re-anticoagulated prior to a thrombotic event, 10 (4.8%) patients experienced a thromboembolic event.
Maltese: Mill-209 pazjent li ġew antikoagulati mill-ġdid qabel avveniment trombotiku, 10 (4.8%) pazjenti esperjenzaw avveniment tromboemboliku.
English: In a similar study, subjects with a median age of 57 years on rivaroxaban 20 mg daily received andexanet alfa (n=26) administered as an 800 mg IV bolus immediately followed by an 8 mg per minute IV infusion for 120 minutes (960 mg) or placebo (n=13).
Maltese: Fi studju simili, individwi b'età medjana ta' 57 sena fuq doża ta' rivaroxaban 20 mg kuljum irċivew andexanet alfa (n = 26) li ngħata bħala bolus ġol-vini ta' 800 mg segwit immedjatament minn infużjoni ġol-vini ta' 8 mg kull minuta għal 120 minuta (960 mg) jew plaċebo (n = 13).
English: Ondexxya 200 mg powder for solution for infusion
Maltese: Ondexxya 200 mg trab għal soluzzjoni għall-infużjoni
English: Of 352 enrolled patients, 249 (70.7%) were included in the efficacy-analysis.
Maltese: Minn 352 pazjent irreġistrat, 249 (70.
English: Powder in a 20 mL vial (Type I glass) with a stopper (butyl rubber).
Maltese: Trab f'kunjett ta' 20 mL (ħġieg tat-Tip I) b'tapp (lastku tal-butyl).
English: Restarting antithrombotic therapy
Maltese: Kif terġa' tinbeda t-terapija antitrombotika
English: In a study comparing andexanet alfa pharmacokinetics in elderly (65-69 years) and younger (26-42 years) healthy subjects who had received apixaban, the pharmacokinetics of andexanet alfa in the elderly subjects were not statistically different than those in the younger subjects.
Maltese: Fi studju li jqabbel il-farmakokinetika ta' andexanet alfa f'individwi b'saħħithom anzjani (65-69 sena) u ta' età aktar żgħira (26-42 sena) li kienu rċivew apixaban, il-farmakokinetika ta' andexanet alfa f'individwi anzjani ma kinitx statistikament differenti minn dik f'individwi ta' età aktar żgħira.
English: • Large (60 mL or larger) sterile syringe.
Maltese: • Siringi sterili kbar (60 mL jew akbar).
English: The safety and efficacy have not been studied in patients with hepatic impairment (see section 5.2).
Maltese: Is-sigurtà u l-effikaċja ma ġewx studjati f'pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: Andexanet alfa will not reverse the effects of non-FXa inhibitors (see section 5.1).
Maltese: Andexanet alfa mhux se jreġġa' lura l-effetti ta' inibituri li mhumiex FXa (ara sezzjoni 5.1).
English: Chemical and physical in-use stability have been demonstrated for 16 hours at 2°C to 8°C in the primary packaging vial.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 16-il siegħa f'temperatura ta' minn 2 sa 8 °C filkunjett tal-pakkett primarju.
English: In order to 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 a global randomised controlled clinical trial to investigate the use of andexanet versus standard of care treatment in patients with intracranial haemorrhage (ICH) taking apixaban, rivaroxaban, or edoxaban (study 18-513).
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' prova klinika globali, ikkontrollata, fejn il-pazjenti ntgħażlu b'mod każwali biex jiġi investigat l-użu ta' andexanet kontra trattament ta' standard tal-kura f'pazjenti b'emorraġija intrakranjali (ICH) li jkunu qed jieħdu apixaban, rivaroxaban, jew edoxaban (studju 18-513).
English: Bolus strengths of andexanet alfa being necessary to achieve mean unbound apixaban (400 mg bolus) and unbound rivaroxaban concentrations (800 mg bolus) below the anticipated respective threshold for no anticoagulant effect were twice as high for rivaroxaban (20 mg QD) compared to apixaban (5 mg BID), due to the differential PK characteristics and dose levels of respective FXa inhibitor.
Maltese: Il-qawwiet tal-bolus ta' andexanet alfa li huma meħtieġa biex jinkisbu konċentrazzjonijiet medji ta' apixaban mhux marbut (400 mg bolus) u rivaroxaban mhux marbut (800 mg bolus) taħt il-limitu antiċipat rispettiv għall-ebda effett antikoagulanti kienu darbtejn aktar għoljin għal rivaroxaban (20 mg QD) meta mqabbel ma' apixaban (5 mg BID), minħabba l-karatteristiċi PK u livelli tad-doża differenzjali tal-inibitur ta' FXa rispettiv.
English: In healthy volunteers, dose-dependent increases in coagulation markers F1+2, TAT, and D-dimer after administration of andexanet alfa were observed, but no thromboembolic events were reported.
Maltese: F'voluntiera b'saħħithom, kienu osservati żidiet dipendenti fuq id-doża fil-markers tal-koagulazzjoni F1+2, TAT u D-dimer wara l-għoti ta' andexanet alfa, iżda ma kienu rrappurtati l-ebda avvenimenti tromboemboliċi.
English: Reversal of rivaroxaban
Maltese: 3%) għal rivaroxaban.
English: The occurrence of thromboembolic events was generally comparable between patients > 75 years (11.0%; 24/219) and those ≤ 75 years of age (9.1%; 12/132).
Maltese: L-okkorrenza ta' avvenimenti tromboemboliċi kienet ġeneralment kumparabbli bejn il-pazjenti li kellhom > 75 sena (11.0%: 24/219) u dawk li kellhom ≤ 75 sena (9.1%: 12/132).
English: Approximately half of the patients were male, and the mean age was 77.4 years.
Maltese: Madwar nofs il-pazjenti kienu rġiel, u l-età medja kienet ta' 77.4 snin.
English: Andexanet alfa reverses the anticoagulant effect of direct factor Xa (FXa) inhibitor products (apixaban, rivaroxaban) only.
Maltese: Andexanet alfa jreġġa' lura l-effett antikoagulanti tal-prodotti li jkun fihom inibituri diretti tal-fattur Xa (FXa) (apixaban, rivaroxaban) biss.
English: Andexanet alfa is not suitable for pre-treatment of urgent surgery.
Maltese: Andexanet alfa mhux adegwat għal trattament minn qabel ta' kirurġija urġenti.
English: Among the apixaban-treated subjects in Study 14-503, the percent change in anti-FXa activity was -92.34% (± 2.809%) for the andexanet alfa group and -32.70% (± 5.578%) for the placebo group (p < 0.0001), the latter reflecting the intrinsic clearance of the anticoagulant.
Maltese: Fost l-individwi ttrattati b'apixaban fl-Istudju 14-503, il-bidla perċentwali fl-attività anti-FXa kienet ta' -92.34% (± 2.809%) għall-grupp ta' andexanet alfa u -32.70% (± 5.578%) għall-grupp tal-plaċebo (p < 0.0001), tal-aħħar jirrifletti t-tneħħija intrinsika tal-antikoagulant.