natgillin/translations-raw huggingface dataset:
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).
Za zbiranje primerjalnih podatkov o varnosti bo imetnik dovoljenja za promet z zdravilom zagotovil končno poročilo o klinični študiji in poročilo o primerjalnih podatkih o varnosti iz randomizirane adaptivne študije faze 3 (15-007) z zdravilom Defibrotide v primerjavi z najboljšo podporno oskrbo za preprečevanje jetrne venookluzivne bolezni pri odraslih in pediatričnih bolnikih s presaditvijo krvotvornih matičnih celic (PKMC).
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.
V sekundarnih analizah podskupine bolnikov, ki so prestajali alogensko presaditev, je bila profilaksa z zdravilom Defitelio prav tako povezana z manjšo incidenco akutne reakcije presadka proti gostitelju (aGvHD) in manjšim številom resnejših primerov (stopnje od 2 do 4) aGvHD do 100.+ dneva.
However, patients would not be expected to drive or operate machinery due to the nature of the underlying disease.
Kljub temu se od bolnikov pričakuje, da zaradi narave osnovne bolezni ne bodo vozili in upravljali s stroji.
In doses above the recommended dose of 25 mg/kg/day there was a higher proportion of patients with bleeding events in the high dose group but since many events occurred in the follow-up period, a clear relationship with defibrotide treatment could not be determined.
Pri odmerkih nad priporočenim odmerkom 25 mg/kg/dan so opazili večji delež bolnikov z dogodki krvavitve v skupini z velikim odmerkom, vendar se je mnogo dogodkov pojavilo v obdobju sledenja, zato jasne povezave z zdravljenjem z defibrotidom ni mogoče določiti.
This means that because of the rarity of this disease and for ethical reasons it has been impossible perform a placebo-controlled clinical trials and to get complete information on this medicine.
To pomeni, da zaradi redkosti bolezni in iz etičnih razlogov ni bilo mogoče opraviti s placebom nadzorovanih kliničnih preskušanj ter pridobiti vseh podatkov o zdravilu.
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).
V ključni študiji 3. faze (študiji 2005-01) je bila skupna pojavnost neželenih dogodkov podobna v skupini, ki se je zdravila z defibrotidom, in kontrolni skupini (zgodovinsko).
The recommended dose is 6.25 mg/kg body weight every 6 hours (25 mg/kg/day).
Priporočeni odmerek je 6,25 mg/kg telesne mase vsakih 6 ur (25 mg/kg/dan).
Other medicines and Defitelio
Druga zdravila in zdravilo Defitelio
After administration of the therapeutic dose (6.25 mg/kg) to healthy subjects, an average of 9.48% of the total dose administered is excreted in urine as unchanged defibrotide in 24 hours, with the majority excreted during the first collection interval of 0-4 hours (approximately 98%).
Po dajanju terapevtskega odmerka (6,25 mg/kg) zdravim osebam se je v povprečju 9,48 % celotnega odmerka v 24 urah izločilo z urinom v obliki nespremenjenega defibrotida, pri čemer se je večina izločila v prvem intervalu odvzema vzorcev od 0 do 4 h (približno 98 %).
Defitelio should not be used during pregnancy unless the clinical condition of the woman requires treatment with Defitelio.
Zdravilo Defitelio ne smete uporabljati med nosečnosti , razen če klinično stanje ženske zahteva zdravljenje z zdravilom Defitelio.
− 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).
− Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1; − sočasna uporaba trombolitične terapije (npr. t-PA) (glejte poglavje 4.5).
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).
Obvestite zdravnika, če jemljete zdravila za preprečevanje strjevanja krvi, kot so acetilsalicilna kislina, heparini, varfarin, dabigatran, rivaroksaban ali apiksaban, ali če jemljete protivnetna zdravila (npr. ibuprofen, naproksen, diklofenak ali druga nesteroidna protivnetna zdravila).
This medicine can be used in adults, and in adolescents, children and infants over one month of age.
To zdravilo se lahko uporablja pri odraslih in mladostnikih, otrocih ter dojenčkih, starejših od enega meseca.
Defitelio has no or negligible influence on the ability to drive and operate machines.
Zdravilo Defitelio nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Defitelio should not be used if the solution is cloudy or contains particles.
Zdravilo Defitelio se ne sme uporabljati, če je motno ali vsebuje delce.
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.
Zdravilo Defitelio je indicirano za zdravljenje hude jetrne venookluzivne bolezni (VOB), imenovane tudi sindrom obstrukcije sinusoidov (SOS), ki se pojavi pri zdravljenju s presaditvijo krvotvornih matičnih celic (PKMC).
Due to this maternal toxicity, no conclusion can be drawn regarding the effects of defibrotide on embryo-foetal development.
Zaradi toksičnosti za mater ni mogoče sklepati glede učinkov defibrotida na razvoj zarodka/ploda.
One carton contains 10 glass vials with 2.5 mL of concentrate each.
Škatla vsebuje 10 steklenih vial z 2,5 ml koncentrata.
The amount of defibrotide excreted in urine over 24 hrs was about 5% of the total dose administered in those with renal impairment versus about 12% in healthy subjects.
Količina defibrotida, ki se je izločila z urinom v 24 urah, je bila pri bolnikih z ledvično okvaro približno 5 % celotnega odmerka v primerjavi s približno 12 % pri zdravih osebah.
Do not use Defitelio
Ne uporabljajte zdravila Defitelio
No dose adjustment is therefore recommended but careful monitoring of patients should be undertaken (see section 5.2).
Prilagajanje odmerka zato ni potrebno, vendar pa je treba bolnike skrbno spremljati (glejte poglavje 5.2).
A bolus administration of Defitelio may cause flushing or a sensation of “generalised heat”.
Uporaba zdravila Defitelio v obliki bolusa lahko povzroči vročinske oblive ali občutek »splošnega pregrevanja«.
• haemothorax (accumulation of blood in the area between the heart and the lung)
• hemotoraks (kopičenje krvi v predelu med srcem in pljuči),
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.
Coppell in sodelavci so leta 2010 poročali o podatkih iz velike metaanalize 235 bolnikov s hudo VOB, pri čemer so pokazali, da je pričakovani delež umrljivosti pri hudi VOB 84,3 %.
In both species, the main findings were accumulation of vacuolated macrophages in liver of dogs and in liver, kidneys and lymph nodes of rats.
Glavna ugotovitev je bila kopičenje vakuoliziranih makrofagov v jetrih psov in jetrih, ledvicah ter bezgavkah podgan.
Defibrotide protects ECs from damage and promotes tissue homeostasis by decreasing fludarabine-mediated apoptosis of EC while maintaining its anti-leukemic effect and by inhibiting the expression of heparanase, shown in in vitro and in vivo studies respectively.
Defibrotid ščiti EC pred poškodbami in pospešuje tkivno homeostazo, tako da zmanjšuje apoptozo EC, ki jo posreduje fludarabin, medtem ko vzdržuje svoj učinek proti levkemiji, in zavira ekspresijo heparanaze, kot so pokazale študije in vitro in in vivo.
Defitelio might be considered free of proarrhythmic toxicity related to QT changes.
Zdravilo Defitelio ne povzroča proaritmične toksičnosti, povezane s spremembami intervala QT.
Like all medicines, Defitelio can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Defitelio neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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.
Podatki o izidih, na voljo za 611 bolnikov, zdravljenih z zdravilom Defitelio, na osnovi sočutne uporabe proti lažji ali hudi VOB po presaditvi so skladni z nadzorovanimi kliničnimi preskušanji, v katerih je bil pri bolnikih s hudo VOB delež popolnega odziva 24 % (51/212) in preživetja 37 %
US Registry data
Preglednica 2: Podatki iz registra ZDA
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.
V skupini, ki je prejemala profilakso z zdravilom Defitelio, so zabeležili 40-odstotno zmanjšanje skupne incidence VOB (od 19,9 % v kontrolni skupini do 12,2 % v skupini z zdravilom Defitelio).
In the Segment II reproductive studies in rats and rabbits, defibrotide has shown maternal toxicity by inducing a high rate of haemorrhagic abortion when infused intravenously over two hours at all dose levels tested including doses close to the human dose.
V študijah razmnoževanja 2. segmenta pri podganah in kuncih so pri defibrotidu pokazali toksičnost za mater, saj je povzročil velik delež abortusov s krvavitvijo, ko se je v dveh urah intravensko infundiral z vsemi preskušanimi ravnmi odmerkov, vključno z odmerki, ki so blizu odmerku pri človeku.
In addition, although in the defibrotide studies in VOD there have been no reports of hypersensitivity, cases of hypersensitivity including anaphylaxis were reported from a previously marketed formulation of defibrotide, consequently hypersensitivity is included as an ADR.
V študijah VOB z defibrotidom ni bilo nobenih poročil o preobčutljivosti, vendar so o primerih preobčutljivosti, vključno z anafilakso, poročali pri pripravku defibrotida, ki je bil predhodno na trgu, zato je preobčutljivost vključena kot neželeni učinek.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
Consideration should be given to discontinuation of Defitelio during use of such therapy.
Med takim zdravljenjem je treba razmisliti o prekinitvi uporabe zdravila Defitelio.
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.
V primerjavi z zdravimi kontrolnimi osebami so pri bolnikih z ledvično okvaro ugotovili 1,6-kratno povečanje vrednosti AUC in 1,4-kratno povečanje vrednosti Cmax, medtem ko je bil razpolovni čas približno dvakrat daljši kot pri zdravih osebah.
• if you are undergoing surgery
• če bodo pri vas opravili kirurški poseg;
Very Common (may affect more than 1 in 10 people )
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
Medicinal products that affect platelet aggregation (e.g. non-steroidal anti-inflammatory agents) should be administered with care, under close medical supervision, during Defitelio administration.
Zdravila, ki vplivajo na agregacijo trombocitov (npr. nesteroidna protivnetna zdravila), je treba med dajanjem zdravila Defitelio uporabljati previdno in pod strogim zdravniškim nadzorom.
No formal pharmacokinetic studies have been performed in hepatic impaired patients.
Pri bolnikih z jetrno okvaro niso opravili nobenih uradnih farmakokinetičnih študij.
It is indicated in adults and in adolescents, children and infants over 1 month of age.
Zdravilo je indicirano pri odraslih in mladostnikih, otrocih ter dojenčkih, starejših od 1 meseca.
Also contains: sodium citrate dihydrate, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections
Vsebuje tudi: natrijev citrat dihidrat, klorovodikovo kislino in natrijev hidroksid (za prilagajanje pH), vodo za injekcije
• 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').
• Druge sestavine zdravila so natrijev citrat dihidrat, klorovodikova kislina ter natrijev hidroksid (za prilagajanje pH) in voda za injekcije (glejte poglavje 2 »Zdravilo Defitelio vsebuje natrij«).
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).
Pri mišjem modelu trombembolije je rekombinantni t-PA okrepil antitrombotični učinek defibrotida, ko se je dajal intravensko, zato lahko sočasna uporaba pomeni povečano tveganje krvavitve in je kontraindicirana (glejte poglavje 4.3).
It is used to treat a condition called hepatic veno-occlusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots.
Uporablja se za zdravljenje jetrne venookluzivne bolezni, pri kateri se krvne žile v jetrih poškodujejo, ker jih zaprejo krvni strdki.
What Defitelio is and what it is used for What you need to know before you are administered Defitelio How you will be given Defitelio.
Kaj je zdravilo Defitelio in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Defitelio Kako boste prejeli zdravilo Defitelio Možni neželeni učinki
Do not use Defitelio if you are pregnant unless your disease requires treatment with Defitelio.
Če ste noseči, ne uporabljajte zdravila Defitelio, razen če bolezen zahteva zdravljenje z zdravilom Defitelio.
No formal pharmacokinetic studies have been performed in patients with hepatic impairment; however, the medicinal product has been used in clinical trials of patients developing hepatic impairment without dose adjustment with no safety issues identified.
Pri bolnikih z jetrno okvaro niso opravili uradnih farmakokinetičnih študij; vendar se je zdravilo uporabljalo v kliničnih preskušanjih pri bolnikih, pri katerih se je začela razvijati jetrna okvara, pri čemer niso ugotovili nobenih težav z varnostjo, čeprav odmerka niso prilagajali.
One mL of concentrate contains 80 mg defibrotide.
En ml koncentrata vsebuje 80 mg defibrotida.
The final concentration of Defitelio should be in the range of 4 mg/mL to 20 mg/mL.
Končna koncentracija zdravila Defitelio mora biti v razponu od 4 mg/ml do 20 mg/ml.
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.
Vendar pa so kemično in fizikalno stabilnost pokazali za 72 ur pri temperaturi 15-25 °C in razponu koncentracije od 4 mg/ml do 20 mg/ml v raztopini za infundiranje z natrijevem kloridom 9 mg/ml (0,9 %) ali 5-odstotno glukozo.
• bleeding in the lungs
• krvavitev v pljučih,
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).
In vitro defibrotid kaže protivnetne učinke, ki zmanjšujejo sproščanje in nastajanje vrst reaktivnega kisika in mediatorjev vnetja, na primer interlevkina 6, tromboksana A2, levkotriena B4 in tumorje nekrotizirajočega faktorja alfa (TNF-α).
The total volume of infusion should be determined based on the individual's patient weight.
Skupno prostornino infuzije je treba določiti na podlagi telesne mase posameznega bolnika.
Safety and efficacy in children aged less than 1 month have not yet been established.
Varnost in učinkovitost pri otrocih, starih manj kot 1 mesec, nista bili še dokazani.
Effective contraception is required for patients and partners of patients during exposure to Defitelio and for one week subsequent to discontinuation.
Bolniki in njihovi partnerji morajo med izpostavljenostjo zdravilu Defitelio in en teden po prekinitvi zdravljenja uporabljati učinkovito kontracepcijo.
Difference in exposure is not considered clinically relevant and so dose adjustment is not advised for patients with renal impairment (see section 4.2).
Razlika v izpostavljenosti ne velja za klinično pomembno, zato se za bolnike z ledvično okvaro ne priporoča prilagoditev odmerka (glejte poglavje 4.2).
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.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml koncentrata vsebuje 80 mg defibrotida*, kar ustreza količini 200 mg v 2,5-ml viali in koncentraciji v razponu od 4 mg/ml do 20 mg/ml po redčenju.
The solution for infusion should be mixed gently.
Raztopino za infundiranje je treba nežno premešati.
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).
Pomembno večji delež bolnikov v skupini, zdravljeni z zdravilom Defitelio, je dosegel popoln odziv, opredeljen kot skupna vrednost bilirubina manj kot 2 mg/dl in ozdravitev večorganske odpovedi; po 100. dnevu je bil popoln odziv pri zdravilu Defitelio 23,5-odstoten (24/102), pri zgodovinski kontroli pa 9,4-odstoten (3/32) (p = 0,013).
Blood and lymphatic system disorders Common
Bolezni krvi in limfatičnega sistema Pogosti koagulopatija
Defibrotide is not removed by dialysis (see section 5.2).
Defibrotid se z dializo ne odstrani (glejte poglavje 5.2).
The tabulated list of adverse reactions incorporates the ADRs observed in study 2005-01 [ADR = any event reported as possibly related on at least two occasions] and TEAEs observed in T-IND 2006-05 study [TEAE = any AE that started or worsened in severity after the first dose of defibrotide].
V preglednici neželenih učinkov so našteti neželeni učinki, opaženi v študiji 2005-01 [vsi neželeni učinki, o katerih so najmanj dvakrat poročali kot o morda povezanih z zdravljenjem], in novi/poslabšani neželeni učinki, opaženi v študiji T-IND 2006-05 [vsi neželeni učinki, ki so se pojavili ali poslabšali po prvem odmerku defibrotida].
Open Label Treatment IND (25mg/kg/day)
Odprto zdravljenje IND (25 mg/kg/dan)
The final concentration of Defitelio should be in the concentration range of 4 mg/mL - 20 mg/mL (see section 6.3).
Končna koncentracija zdravila Defitelio mora biti v razponu od 4 mg/ml do 20 mg/ml (glejte poglavje 6.3).
Historically Controlled Trial (25mg/kg/day) Defibrotide treated group
Zgodovinsko nadzorovano preskušanje (25 mg/kg/dan) Skupina, zdravljena z defibrotidom
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).
Študije in vitro in in vivo so pokazale, da defibrotid inhibira adhezijo levkocitov in trombocitov na endotelij, tako da: zavira P-selektin in žilno adhezijsko molekulo 1 (vascular cell adhesion molecule-1 - VCAM-1), ovira transmigracijo levkocitov, ki jo posreduje molekula medcelične adhezije z antigenom 1 (LFA-1-ICAM), povezana s funkcijo limfocitov; in zvečuje dušikov oksid (NO), prostaglandin I2 (PGI2) in prostaglandin E2 (PGE2).
From a microbiological point of view, after dilution, the reconstituted medicinal product should be used immediately.
Stabilnost po prvem odprtju in/ali redčenju: z mikrobiološkega stališča je treba rekonstituirano zdravilo uporabiti takoj po redčenju.
Non-defibrotide treated Defibrotide treated
Brez defibrotida Zdravljeni z defibrotidom
Defitelio is for single use only.
Zdravilo Defitelio je namenjeno samo enkratni uporabi.
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.
Defibrotid je pokazal antitrombotične in fibrinolitične učinke in vitro in in vivo, tako da: zvečuje ekspresijo sistemskega inhibitorja poti tkivnega faktorja (TFPI-tissue factor pathway inhibitor), tkivnega aktivatorja plazminogena (tissue plasminogen activator - t-PA) in trombomodulina (TM); zmanjšuje ekspresijo von Willebrandovega faktorja (vWF) in inhibitorja aktivatorja plazminogena 1 in zvečuje encimsko aktivnost plazmina za hidroliziranje fibrinskih strdkov.
Defitelio pharmacokinetic parameters after intravenous infusion of 6.25 mg/kg to healthy subjects.
Preglednica 3: Farmakokinetični parametri zdravila Defitelio po intravenskem infundiranju 6,25 mg/kg pri zdravih preskušancih.
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.
Najpogostejša neželena učinka, opažena med zdravljenjem jetrne VOB, sta krvavitev (ki med drugim vključuje gastrointestinalno krvavitev, pljučno krvavitev in epistakso) in hipotenzija.
In a sub-study it was shown that haemodialysis did not remove defibrotide (see section 4.2)
Podštudija je pokazala, da hemodializa ne odstrani defibrotida (glejte poglavje 4.2).
• bleeding from the eye
• krvavitev iz očesa,
STATEMENT OF ACTIVE SUBSTANCE(S)
Ugotavljanje odmerka (skupina s
• Data analysis from CIBMTR for patients treated and not treated with defibrotide
• analizo podatkov bolnikov, ki so se zdravili in se niso zdravili z defibrotidom, iz centra CIBMTR (Center for International Blood and Marrow Transplant Research).
Defitelio has been used in clinical trials in patients with hepatic impairment without dose adjustment with no major safety issues identified (see section 4.2).
Zdravilo Defitelio se je v kliničnih preskušanjih brez prilagajanja odmerka uporabljalo pri bolnikih z jetrno okvaro, pri čemer niso opazili nobenih težav z varnostjo (glejte poglavje 4.2).
The use of Defitelio in children aged less than one month is not recommended.
Uporaba zdravila Defitelio pri otrocih, mlajših od enega meseca, ni priporočljiva.
You must not be given a double dose to make up for a missed dose.
Če je bil odmerek izpuščen, ne smete prejeti dvojnega odmerka.
Each 2.5 mL vial contains 200 mg defibrotide.
Ena 2,5-mililitrska viala vsebuje 200 mg defibrotida.
A controlled randomised prophylaxis study (Study 2004-000592-33) was conducted in the paediatric patients undergoing HSCT.
Pri pediatričnih bolnikih, ki so prestajali PKMC, so opravili nadzorovano, randomizirano študijo profilakse (študijo 2004-000592-33).
The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary
Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo.
In 52 healthy volunteers, after a single 6.25 mg/kg dose of Defitelio given as a 2-hour infusion, the pharmacokinetic parameters were as follows:
Pri 52 zdravih prostovoljcih so bili farmakokinetični parametri po odmerku zdravila Defitelio 6,25 mg/kg naslednji: