FrancophonIA/ELRC3.0 huggingface dataset:
English: Defitelio PK Parameters Mean ± SD
Maltese: Parametri PK ta' Defitelio Medja ± SD
English: 22079 Italy
Maltese: 22079 L-Italja
English: 200 mg/2.5 mL
Maltese: 2.5 mL
English: Summary of the Safety Profile
Maltese: Sommarju tal-Profil tas-Sigurtà
English: Piazza XX Settembre, 2 22079 Villa Guardia (Como) Italy
Maltese: Piazza XX Settembre, 2 22079 Villa Guardia (Como) L-Italja
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 October 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18 ta' Ottubru 2013
English: Date of latest renewal: 26 July 2018
Maltese: Data tal-aħħar tiġdid: 26 ta 'Lulju 2018
English: Frequencies are defined as: 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).
Maltese: Il-frekwenzi huma definiti bħala: 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).
English: Pharmaswiss Hellas A.E.
Maltese: Ελλάδα, Κύπρος Pharmaswiss Hellas A.E.
English: Defibrotide does not inhibit or induce CYP450s.
Maltese: Defibrotide ma jinibixxix u lanqas ma jinduċi CYP450s.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/878/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/878/001
English: *=Kaplan Meier estimates for time-to-event analysis by Day100
Maltese: *=Stimi ta' Kaplan Meier għal analiżi ħin sal-avveniment sa Jum+100
English: Tel: +385 1 6311 833 croatia.info@bauschhealth.com
Maltese: +385 1 6311 833 croatia.info@bauschhealth.com
English: Pulmonary haemorrhage Epistaxis
Maltese: Emorraġija pulmonari Epistassi
English: Volume of distribution is around 10 L. In vitro studies demonstrate that 93% of Defitelio is bound to plasma proteins.
Maltese: Studji in vitro juru li 93% ta' Defitelio jeħel malproteini tal-plasma.
English: Defitelio is a medicine that contains the active substance defibrotide.
Maltese: Defitelio huwa mediċina li fiha s-sustanza attiva defibrotide.
English: Coppell et al in 2010 reported data from a large meta-analysis of 235 patients with severe VOD showing a background mortality rate of severe VOD of 84.3% and that this mortality rate has remained constant over several decades.
Maltese: Coppell et al fl-2010 irrapporta dejta minn meta-analiżi kbira ta' 235 pazjent b'VOD severa u dan juri rata ta' mortalità fl-isfond ta' VOD severa ta' 84.
English: 2.5 mL vials (Type I clear glass), closed with a stopper (butyl rubber) and seal (aluminium).
Maltese: 2.5 mL kunjetti (Tip I ħġieġ ċar), magħluq b'tapp (gomma butyl) u b'siġill (aluminju).
English: Hypersensitivity Anaphylactic reaction
Maltese: Sensittività eċċessiva Reazzjoni anafilattika
English: Historically Controlled Trial (25mg/kg/day) Defibrotide treated group
Maltese: Prova Kkontrollata Storikament (25 mg/kg/jum) Grupp Ikkurat b'Defibrotide
English: Historical Control
Maltese: Kontroll Storiku
English: Outcome data available from 611 patients treated with Defitelio on a compassionate use basis for non-severe and severe VOD post-transplant, are consistent with the controlled clinical trials, with complete response rate 24% (51/212) and survival 37% (78/212) in the subset of patients with severe VOD.
Maltese: Dejta li rriżultat, disponibbli minn 611-il pazjent ikkurati b'Defitelio fuq bażi ta' użu b'kumpassjoni għal VOD wara t-trapjant, mhux severa u severa, hija konsistenti mal-provi kliniċi kkontrollati, b'rata ta' rispons komplet 24% (51/212) u 37% sopravivenza (78/212) fis-subsett ta' pazjenti b'VOD severa.
English: In vitro and in vivo studies have demonstrated that defibrotide inhibits leukocyte and platelet adhesion to endothelium by: suppressing P-selectin and vascular cell adhesion molecule-1 (VCAM)-1; interfering with lymphocyte function-associated antigen 1-intercell adhesion molecule (LFA-1-ICAM) mediated leukocyte transmigration; and increasing nitric oxide (NO), Prostaglandin I2 (PGI2) and Prostaglandin E2 (PGE2).
Maltese: Studji in vitro u in vivo wrew li defibrotide jinibixxi l-adeżjoni tal-lewkoċiti u l-plejtlits mal-endotelju billi: jissopprimi l-molekula ta' adeżjoni P-selectin u taċ-ċellula vaskulari-1 (VCAM-1, vascular cell adhesion molecule); jinterferixxi mat-trasmigrazzjoni tal-lewkoċiti medjata mill-molekula tal-adeżjoni interċellulari-1 tal-antiġen b'funzjoni assoċjata mal-limfoċiti (LFA-1-ICAM, lymphocyte functionassociated antigen 1-intercell adhesion molecule); u jżid in-nitric oxide (NO), il-Prostaglandin I2 (PGI2) u l-Prostaglandin E2 (PGE2).
English: Concentrate for solution for infusion (sterile concentrate).
Maltese: Konċentrat għal soluzzjoni għal infużjoni (konċentrat sterili).
English: This is called an ‘intravenous infusion' or drip.
Maltese: Dan jissejjaħ 'infużjoni intravenuża' jew dripp.
English: Accumulation of defibrotide over 4 doses was not found.
Maltese: Ma nstabitx akkumulazzjoni ta' defibrotide fuq 4 dożi.
English: However, chemical and physical in-use stability has been demonstrated for 72 hours at 15-25°C for a concentration range of 4 mg/mL to 20 mg/mL in sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose solution for infusion at 15-25ºC for 72 hours.
Maltese: Madankollu, l-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 72 siegħa f'15-25°C għal medda ta' konċentrazzjoni ta' 4 mg/mL sa 20 mg/mL f'sodium chloride 9 mg/mL (0.9%) soluzzjoni għal infużjoni jew 5% glucose soluzzjoni għal infużjoni fi 15-25ºC għal 72 siegħa.
English: The final concentration of Defitelio should be in the range of 4 mg/mL to 20 mg/mL.
Maltese: Il-konċentrazzjoni finali ta' Defitelio għandha tkun fil-medda ta' 4 mg/mL sa 20 mg/mL.
English: In vitro defibrotide demonstrates anti-inflammatory effects that attenuate the release and production of reactive oxygen species and inflammatory mediators such as interleukin 6, thromboxane A2, leukotriene B4 and tumour necrosis factor-α (TNF-α).
Maltese: Defibrotide in vitro juri effetti anti-infjammatorji li jtaffu r-rilaxx u l-produzzjoni ta' speċi tal-ossiġnu reattivi u medjaturi infjammatorji bħal interleukin 6, thromboxane A2, leukotriene B4 u l-fattur-α tannekrożi tat-tumur (TNF-α).
English: Defitelio pharmacokinetic parameters after intravenous infusion of 6.25 mg/kg to healthy subjects.
Maltese: Il-parametri farmakokinetiċi ta' Defitelio wara infużjoni ġol-vini ta' 6.25 mg/kg f'suġġetti b'saħħithom.
English: Defibrotide has demonstrated antithrombotic and fibrinolytic effects in vitro and in vivo by: increasing systemic tissue factor pathway inhibitor (TFPI), tissue plasminogen activator (t-PA) and thrombomodulin (TM) expression; decreasing von Willebrand factor (vWF) and plasminogen activator inhibitor-1 (PAI-1) expression; and enhancing the enzymatic activity of plasmin to hydrolyse fibrin clots.
Maltese: Defibrotide wera effetti antitrombotiċi u fibrinolitiċi in vitro u in vivo billi: żied l-inibitur tal-passaġġ tal-fattur tat-tessut (TFPI, tissue factor pathway inhibitor) sistemiku, l-attivatur tal-plasminoġen tat-tip tat-tessut (t-PA) u l-espressjoni ta' trombomodulin (TM, thrombomodulin); naqqas il-fattur von Willebrand (vWF, von Willebrand factor); u tejjeb l-attività enzimatika tal-plasmin biex jidrolizza lemboli tal-fibrin.
English: Survival by Day+100
Maltese: Sopravivenza sa Jum+100
English: Also contains: sodium citrate dihydrate, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections
Maltese: Fih ukoll: sodium citrate dihydrate, hydrochloric acid and sodium hydroxide (għall-aġġustament talpH), ilma għall-injezzjonijiet
English: A significantly higher proportion of patients in the Defitelio treated group achieved a complete response defined as total bilirubin less than 2 mg/dL and resolution of MOF (multiple organ failure); Day+100 complete response was 23.5% (24/102) with Defitelio versus 9.4% (3/32) in the historical control (p=0.013).
Maltese: Proporzjon ferm akbar ta' pazjenti fil-grupp ikkurat b'Defitelio kiseb rispons sħiħ definit bħala bilirubin totali ta' inqas minn 2 mg/dL u riżoluzzjoni ta' MOF (kollass ta' aktar minn organu wieħed); Rispons sħiħ Jum+100 kien 23.5% (24/102) b'Defitelio mqabbel ma' 9.4% (3/32) fil-kontroll storiku (p=0.013).
English: Defibrotide is not removed by dialysis (see section 5.2).
Maltese: Defibrotide ma jitneħħiex b'dijaliżi (ara sezzjoni 5.2).
English: Six patients with an estimated glomerular filtration rate <30 mL/min/1.73m2 (calculated using the Modification of Diet in Renal Disease equation) and not currently on dialysis were compared to 6 healthy subjects with similar baseline demographics.
Maltese: Sitt pazjenti b'rata stmata ta' filtrazzjoni glomerulari ta' <30 mL/min/1.73 m² (ikkalkulata bl-użu talekwazzjoni tal-Modifika tad-Dieta fil-Mard tal-Kliewi - Modification of Diet in Renal Disease equation) ma kinux fuq id-dijalisi tqabblu ma' 6 individwi b'saħħithom b' demografiċi ta' linja bażi simili.
English: At an interim analysis of the on-going registry, data from 96 patients with severe VOD were available.
Maltese: F'analiżi interim tar-reġistru kontinwu, kien hemm dejta minn 96 pazjent b'VOD severa.
English: Renal impairment
Maltese: Tużax Defitelio
English: Each 2.5 mL vial contains 200 mg defibrotide and each mL solution contains 80 mg defibrotide.
Maltese: Kull kunjett ta' 2.5 mL fih 200 mg defibrotide u kull mL soluzzjoni fiha 80 mg defibrotide.
English: Pharmacotherapeutic group: other antithrombotic agents; ATC code: B01AX01.
Maltese: Sustanzi antitrombotiċi oħra; Kodiċi ATC:
English: Marketing Authorisation Holder and Manufacturer Gentium Srl
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Gentium Srl
English: Compared to healthy controls, subjects with renal impairment demonstrated 1.6- and 1.4-fold increases in AUC and Cmax, respectively and a half-life of about twice that of healthy subjects.
Maltese: Meta mqabbla ma' kontrolli b'saħħithom, l-individwi b'indeboliment tal-kliewi urew żieda ta' 1.6 u 1.4 drabi f'AUC u Cmax, rispettivament u half life ta' madwar darbtejn dik tal-individwi b'saħħithom.
English: The recommended dose is 6.25 mg/kg body weight every 6 hours (25 mg/kg/day).
Maltese: Id-doża rakkomandata hija 6.25 mg/kg piż tal-ġisem kull 6 sigħat (25 mg/kg/jum).
English: Potential interactions with antithrombotic fibrinolytic agents Defibrotide has a profibrinolytic effect (see section 5.1) and this may potentially enhance the activity of antithrombotic/fibrinolytic medicinal products.
Maltese: Defibrotide għandu effett profibrinolitiku (ara sezzjoni 5.1) u dan jista' potenzjalment issaħħaħ lattività ta' prodotti mediċinali antitrombotiċi/fibrinolitiċi.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 10 vials
Maltese: U KONTENUT Konċentrat għal soluzzjoni għal infużjoni 10 kunjetti
English: Defibrotide is an oligonucleotide mixture with demonstrated antithrombotic, fibrinolytic, anti-adhesive and anti-inflammatory actions.
Maltese: Defibrotide huwa taħlita ta' oligonukleotide b'azzjonijiet murija antitrombotiċi, fibrinolitiċi, ta' kontra l-adeżjoni u anti-infjammatorji.
English: Complete Response by Day+100
Maltese: Rispons Sħiħ sa Jum+100
English: A controlled randomised prophylaxis study (Study 2004-000592-33) was conducted in the paediatric patients undergoing HSCT.
Maltese: Studju ta' profilassi randomizzata kkontrollat (Studju 2004-000592-33) twettaq fuq pazjenti pedjatriċi li kienu qegħdin jagħmlu HSCT.
English: In order to collect comparative safety data, the MAH will provide the final CSR and a report of comparative safety data from the Phase 3, randomised, adaptive study (15-007) of Defibrotide vs best supportive care in the prevention of hepatic venoocclusive disease in adult and paediatric patients undergoing hematopoietic stem cell transplant (HSCT).
Maltese: Sabiex tinġabar dejta tas-sigurtà komparattiva, il-MAH ser jipprovdi s-CSR finali u rapport ta' dejta tas-sigurtà komparattiva mill-istudju ta' Fażi 3, randomised, adattiv (15007) ta' defibrotide kontra l-aħjar kura ta' sostenn fil-prevenzjoni ta' marda venookklussiva epatika f'pazjenti adulti u f'pazjenti pedjatriċi li jkunu qegħdin jagħmlu trapjant taċ-ċelloli staminali ematopojetiċi (HSCT).
English: • coagulopathy (disturbance of blood clotting)
Maltese: • koagulopatija (disturbi fl-għaqid tad-demm)
English: Pregnancy and breast-feeding
Maltese: Żvilupp embriju-fetali
English: Juvenile toxicity
Maltese: Tossiċità ġuvenili
English: In the Phase 3 pivotal treatment study (2005-01 Study), the overall incidence of adverse events was similar in the defibrotide treatment group and in the control group (historical).
Maltese: Fi studju pivotali tal-kura ta' Fażi 3 (Studju 2005-01), l-inċidenza ġenerali tal-avvenimenti avversi kienet simili fil-grupp ta' kura ta' defibrotide u fil-grupp ta' kontroll (storiku).
English: A 40% reduction in the overall incidence of VOD in the Defitelio prophylaxis arm (from 19.9% in the control arm to 12.2% in the Defitelio arm), has been shown.
Maltese: Intwera tnaqqis ta' 40% fl-inċidenza totali ta' VOD fil-fergħa tal-profilassi ta' Defitelio (minn 19.9% fil-fergħa ta' kontroll għal 12.2% fil-fergħa ta' Defitelio).
English: The combined volumes of Defitelio should be added to the sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion.
Maltese: Il-volumi kkombinati ta' Deitelio għandhom jiżdiedu mas-soluzzjoni ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għal infużjoni jew glucose 5% soluzzjoni għal infużjoni.
English: Defitelio should be diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose solution for infusion (see section 6.3 for concentration range and stability of the diluted solution) to a suitable concentration to permit 2 hours infusion time (see section 4.2).
Maltese: Defitelio għandu jiġi dilwit ma' sodium chloride 9 mg/mL (0.9%) soluzzjoni għal infużjoni jew 5% glucose soluzzjoni għal infużjoni (ara sezzjoni 6.3 għal medda ta' konċentrazzjoni u stabbilita' tassoluzzjoni dilwita) għal konċentrazzjoni stabbli sabiex ikun hemm ħin ta' infużjoni ta' sagħtejn (ara sezzjoni 4.2).
English: Data derived from an independent US registry have shown a beneficial effect of Defitelio in routine clinical practice.
Maltese: Dejta miksuba minn reġistru indipendenti tal-US uriet effett ta' benefiċċju ta' Defitelio fil-prattika klinika ta' rutina.
English: Potential interactions with other medicinal products Defibrotide does not inhibit or induce CYP450s (see section 5.2).
Maltese: Defitelio ma jinibixxix u lanqas ma jinduċi CYP450s (ara sezzjoni 5.2).
English: Open Label Treatment IND (25mg/kg/day)
Maltese: Tfittxija tad-Doża (Fergħa 25 mg/kg/jum)
English: In a sub-study it was shown that haemodialysis did not remove defibrotide (see section 4.2)
Maltese: F'sottostudju ntwera li l-emodijalisi ma neħħietx defibrotide (ara sezzjoni 4.2).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) f'kull doża, jiġifieri huwa essenzjalment ‘ħieles mis-sodium'.
English: The most frequent adverse reactions observed during the treatment of hepatic VOD are haemorrhage (including but not limited to gastrointestinal haemorrhage, pulmonary haemorrhage and epistaxis) and hypotension.
Maltese: L-aktar reazzjonijiet avversi frekwenti osservati matul il-kura ta' VOD epatika huma emorraġija (inkluż iżda mhux limitat għal emorraġija gastro-intestinali, emorraġija pulmonari u epistassi) u pressjoni għolja.
English: In secondary analyses on the subset of patients undergoing allogeneic transplants, Defitelio prophylaxis was also associated with a lower incidence and less Grade 2 to 4 severity of acute graft versus host disease (aGvHD) by Day+100.
Maltese: F'analiżi sekondarja fuq is-subsett ta' pazjenti li kienu qegħdin jagħmlu trapjanti alloġeneiċi, profilassi ta' Defitelio kienet assoċjata wkoll ma' inċidenza iktar baxxa u ma' inqas każijiet b'severità ta' Grad 2 sa 4 ta' marda akuta ta' graft versus host (aGvHD) sa Jum+100.
English: Concomitant systemic anticoagulant therapy (e.g. heparin, warfarin, direct thrombin inhibitors and direct factor Xa inhibitors) (see section 4.5), except for routine maintenance or reopening of central venous line, requires careful monitoring.
Maltese: L-użu fl-istess ħin ta' terapija antikoagulanti sistemika (eż. eparina, warfarina, inibituri tat-trombin diretti u inibituri tal-fattur Xa diretti) (ara sezzjoni 4.5), għajr linja ta' manutenzjoni ta' rutina jew ftuħ mill-ġdid ta' linja venuża ċentrali, jeħtieġ monitoraġġ attent.
English: Phone: +39 031 5373200 Fax: +39 031 5373241 info@gentium.it
Maltese: Fax: +39 031 5373241 info@gentium.it
English: The efficacy and safety of defibrotide in the treatment of severe VOD were studied in a pivotal Phase 3 historical-controlled study (2005-01).
Maltese: L-effikaċja u s-sigurtà ta' defibrotide fil-kura ta' VOD severa ġew studjati fi studju kkontrollat blistorja ta' Fażi-3 pivotali (2005-01).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of concentrate contains defibrotide* 80 mg corresponding to a quantity of 200 mg in 2.5 mL in a vial, and corresponding to a concentration in the range of 4 mg/mL to 20 mg/mL after dilution.
Maltese: mL wieħed ta' konċentrat fih defibrotide* 80 mg li jikkorrespondi għal kwantità ta' 200 mg f'2.5 mL f'kunjett, u jikkorrespondi għal konċentrazzjoni fil-medda ta' 4 mg/mL sa 20 mg/mL wara ddilwizzjoni. * prodott minn mukoża intestinali tal-majjali.
English: In addition, Day+100 survival rate was improved in the Defitelio group with 38.2% (39/102) of the patients surviving versus 25.0% (8/32) in the historical control group (p=0.034).
Maltese: Barra minn hekk, rata ta' sopravivenza ta' Jum+100 tjiebet fil-grupp ta' Defitelio bi 38.2% (39/102) tal-pazjenti jibqgħu jgħixu meta mqabbel ma' 25.
English: The Day+100 all-cause mortality in patients with severe VOD who were not treated with defibrotide was 69%, and 61% in those patients who received defibrotide.
Maltese: Il-mortalita' b'kull kawża sa Jum+100 f'pazjenti b'VOD severa li ma ġewx ikkurati b'defibrotide kienet 69%, u 61% f'dawk il-pazjenti li rċievew defibrotide.
English: Maximum plasma concentrations peaked at the end of the infusion period and declined thereafter with a rapid clearance and most of samples were undetectable 3.5 hours after the start of the infusion.
Maltese: Konċentrazzjonijiet massimi fil-plasma laħqu massimu fit-tmiem tal-perjodu ta' infużjoni u naqsu wara b'eliminazzjoni rapida u ħafna mill-kampjuni ma baqgħux jiġu rilevati 3.5 sigħat wara l-bidu talinfużjoni.
English: Rash Pruritus Petechiae
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Tell your doctor if you are taking medicines to prevent blood clotting such as acetylsalicylic acid, heparins, warfarin, dabigatran, rivaroxaban or apixaban or if you are taking anti-inflammatory medicines (e.g., ibuprofen, naproxen, diclofenac and other non-steroidal anti-inflammatory medicines).
Maltese: Għid lit-tabib tiegħek jekk qed tieħu mediċini sabiex jimpedixxu għaqid tad-demm bħal acetylsalicylic acid, ħeparini, warfarin, dabigatran, rivaroxaban jew apixaban jew jekk qed tieħu mediċini antiinfjammatorji (eż., ibuprofen, naproxen, diclofenac u mediċini anti-infjammatorji, mhux sterojdali oħrajn).
English: As you will be given this medicine by a doctor or a nurse it is unlikely that a dose will be missed.
Maltese: Minħabba li inti se tirċievi din il-mediċina minn tabib jew infermier, mhuwiex probabbli li se taqbeż id-doża.
English: − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 − Concomitant use of thrombolytic therapy (e.g. t-PA) (see section 4.5).
Maltese: − Użu fl-istess ħin ta' terapija trombolitika (eż. t-PA) (ara sezzjoni 4.5).
English: Piazza XX Settembre 2 Villa Guardia 22079 Italy
Maltese: Piazza XX Settembre 2 Villa Guardia
English: • The other ingredients are sodium citrate dihydrate, hydrochloric acid and sodium hydroxide (both for pH-adjustment) and water for injections (see section 2 ‘Defitelio contains Sodium').
Maltese: • Is-sustanzi mhux attivi l-oħra huma sodium citrate dihydrate, hydrochloric acid u sodium hydroxide (it-tnejn li huma għall-aġġustament tal-pH) u ilma għall-injezzjonijiet (ara sezzjoni 2 “Defitelio fih Sodju”).
English: Embryo-foetal developmental toxicology studies in pregnant rats and rabbits of defibrotide doses close to the recommended therapeutic human dose, revealed a high rate of haemorrhagic abortion (see section 5.3).
Maltese: Studji dwar effett tossiku fuq l-iżvilupp embrijofetali f'firien u fi fniek tqal ta' dożi ta' defibrotide qrib id-doża umana terapewtika rakkomandata, urew rata għolja ta' abort emorraġiku (ara sezzjoni 5.3).
English: In the paediatric prevention study at 25 mg/kg/day there was an increased incidence of any bleeding events in the defibrotide group compared with the treatment group.
Maltese: Fl-istudju ta' prevenzjoni pedjatrika b'25 mg/kg/jum, kien hemm inċidenza miżjuda ta' kwalunkwe episodju ta' fsada fil-grupp ta' defibrotide meta mqabbel malgrupp tal-kura.
English: Defitelio 80 mg/mL concentrate for solution for infusion defibrotide
Maltese: Defitelio 80 mg/mL konċentrat għal soluzzjoni għal infużjoni defibrotide
English: • Data analysis from CIBMTR for patients treated and not treated with defibrotide
Maltese: • Analiżi tad-dejta minn CIBMTR għal pazjenti kkurati u mhux ikkurati b'defibrotide
English: One mL of concentrate contains 80 mg defibrotide.
Maltese: ATTIVA(I) mL wieħed ta' konċentrat fih 80 mg defibrotide.
English: Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.
Maltese: Defitelio huwa indikat għall-kura ta' marda veno-okklussiva epatika (VOD - veno-occlusive disease) severa, magħrufa wkoll bħala sindrome ostruzzjoni sinusojdali (SOS - sinusoidal obstruction syndrome) f'kura li tinvolvi trapjant taċ-ċelloli staminali ematopojetiċi (HSCT - haematopoietic stemcell transplantation).
English: PAI-2 is known to be uniquely up-regulated in the placenta.
Maltese: PAI-2 huwa magħruf li huwa regolat 'l fuq b'mod uniku fil-plaċenta.
English: In a mouse model of thromboembolism, recombinant t-PA potentiated the antithrombotic effect of defibrotide when given intravenously and thus co-administration may present an increased risk of haemorrhage and is contraindicated (see section 4.3).
Maltese: F'mudell fuq ġurdien ta' tromboemboliżmu, t-PA rikombinanti saħħaħ l-effett antitrombotiku ta' defibrotide meta mogħti ġol-vini u b'hekk, l-għoti fl-istess ħin jista' jippreżenta riskju miżjud ta' emorraġija u huwa kontraindikat (ara sezzjoni 4.3).
English: In each of the clinical trials performed in the treatment of VOD, over 50% of patients were under the age of 18 years.
Maltese: F'kull waħda mill-provi kliniċi mwettqa fil-kura ta' VOD, aktar minn 50% tal-pazjenti kellhom inqas minn 18-il sena.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Defitelio 80 mg/mL sterile concentrate defibrotide
Maltese: U MNEJN GĦANDU JINGĦATA Defitelio 80 mg/mL konċentrat sterili defibrotide
English: Each 2.5 mL vial contains 200 mg defibrotide.
Maltese: Kull kunjett ta' 2.5 mL fih 200 mg defibrotide. 200 mg/2.5 mL
English: Haematuria
Maltese: Miżura
English: Gastrointestinal haemorrhage Vomiting
Maltese: Emorraġija gastro-intestinali
English: • haemothorax (accumulation of blood in the area between the heart and the lung)
Maltese: • ematoraċe (akkumulazzjoni ta' demm fiż-żona ta' bejn il-qalb u l-pulmun)
English: Defitelio might be considered free of proarrhythmic toxicity related to QT changes.
Maltese: Defitelio jista jintuża waqt it-treddigħ.
English: Macrophages are considered the main target organ.
Maltese: Il-makrofaġi huma meqjusin bħala l-organu prinċipali filmira.
English: Gastrointestinal disorders: Common
Maltese: Disturbi gastro-intestinali Komuni