FrancophonIA/ELRC3.0 huggingface dataset:
English: It is indicated in adults and in adolescents, children and infants over 1 month of age.
Croatian: Indiciran je u odraslih i adolescenata, djece i dojenčadi starije od 1 mjeseca.
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.
Croatian: Coppell i suradnici zabilježili su 2010. podatke iz velike metaanalize provedene na 235 bolesnika s teškom veno-okluzivnom bolešću, koji su pokazali osnovnu stopu smrtnosti zbog teške venookluzivne bolesti od 84,3% te da je ta stopa smrtnosti ostala konstantna tijekom nekoliko desetljeća.
English: • localized blood collection out of the vessel (hematoma) in the brain
Croatian: • lokalizirano nakupljanje krvi izvan žile (hematom) u mozgu
English: Only clear solutions without visible particles should be used.
Croatian: Smiju se primijeniti samo bistre otopine bez vidljivih čestica.
English: Defitelio should not be used during pregnancy unless the clinical condition of the woman requires treatment with Defitelio.
Croatian: Defitelio se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje lijekom Defitelio.
English: The recommended dose is 6.25 mg/kg body weight every 6 hours (25 mg/kg/day).
Croatian: Preporučena doza je 6,25 mg/kg tjelesne težine svakih 6 sati (25 mg/kg na dan).
English: Defibrotide does not inhibit or induce CYP450s.
Croatian: Defibrotid ne inhibira niti ne inducira enzime CYP450.
English: Once diluted for use the infusion storage should not exceed 24 hours at 2°C -8°C unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Nakon što je lijek razrijeđen za primjenu, vrijeme čuvanja infuzije ne smije prijeći 24 sata na temperaturi od 2°C do 8°C, osim kada je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
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.
Croatian: Koncentracija defibrotida u plazmi doseže maksimalnu vršnu vrijednost na kraju razdoblja infuzije, a nakon toga opada uz brzi klirens pa se većina uzoraka nije mogla detektirati 3,5 sata nakon početka infuzije.
English: The number of vials to be diluted should be determined based on the individual patient's weight (see section 4.2).
Croatian: Broj bočica koje treba razrijediti određuje se na temelju tjelesne težine svakog pojedinog bolesnika (vidjeti dio 4.2).
English: For adverse reactions reported in both studies, the highest frequency was used in the table below.
Croatian: Za nuspojave prijavljene u oba ispitivanja, najveća učestalost navedena je u tablici u nastavku.
English: Like all medicines, Defitelio can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: 2.5 mL vials (Type I clear glass), closed with a stopper (butyl rubber) and seal (aluminium).
Croatian: Bočice od 2,5 ml (prozirno staklo tip I), zatvorene čepom (butilna guma) i nepropusno zatvorene (aluminij) .
English: The required volume from the Defitelio vials should be withdrawn and combined.
Croatian: Potrebni volumen lijeka Defitelio treba izvući iz bočica i sjediniti.
English: Individual Studies
Croatian: Pojedinačna ispitivanja
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 10 vials
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 10 bočica
English: 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.
Croatian: Što je Defitelio i za što se koristi Što morate znati prije nego počnete primjenjivati Defitelio Kako će Vam primjenjivati Defitelio Moguće nuspojave
English: No dose adjustment is therefore recommended but careful monitoring of patients should be undertaken (see section 5.2).
Croatian: Stoga se ne preporučuje prilagodba doze, ali bolesnike treba pažljivo nadzirati (vidjeti dio 5.2).
English: Defitelio may be used during breastfeeding.
Croatian: Defitelio se može primjenjivati tijekom dojenja.
English: One carton contains 10 glass vials with 2.5 mL of concentrate each.
Croatian: Jedna kutija sadrži 10 staklenih bočica sa 2,5 ml koncentrata u svakoj.
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).
Croatian: Djelotvornost i sigurnost defibrotida u liječenju teške veno-okluzivne bolesti bile su ispitane u fazi 3 pivotalnog ispitivanja s povijesnom kontrolnom skupinom (2005-01).
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).
Croatian: Osim toga, stopa preživljenja na dan+100 poboljšala se u skupini koja je primala Defitelio sa 38,2% (39/102) bolesnika s preživljenjem naspram 25,0% (8/32) u povijesnoj kontrolnoj skupini (p=0,034).
English: Vials are intended for a single use and unused solution from a single dose must be discarded (see section 6.6)
Croatian: Bočice su namijenjene za jednokratnu uporabu, a neupotrijebljena otopina preostala od jedne doze mora se baciti (vidjeti dio 6.6).
English: Based on the results of the QTc study, conducted in healthy subjects at therapeutic and supra-therapeutic doses, it can be concluded that Defitelio has no significant or clinically relevant QTc-prolonging potential at doses up to 4 times higher than therapeutically indicated.
Croatian: Na temelju rezultata ispitivanja QTc provedenog u zdravih ispitanika pri terapijskim i supraterapijskim dozama, može se zaključiti da Defitelio nema značajni ili klinički važan učinak na produljenje QTc-intervala pri dozama do 4 puta višim od terapijski indiciranih doza.
English: 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.
Croatian: Osim toga, iako u ispitivanjima s defibrotidom u veno-okluzivnoj bolesti nisu bile prijavljene reakcije preosjetljivosti, slučajevi preosjetljivosti uključujući anafilaksiju zabilježeni su za prethodnu formulaciju defibrotida koja se nalazila na tržištu, pa je posljedično tome preosjetljivost uključena kao jedna od nuspojava.
English: The recommended dose for children aged 1 month to 18 years is the same mg/kg dose as for adults i.e. 6.25 mg/kg body weight every 6 hours.
Croatian: Preporučena doza za djecu u dobi od 1 mjeseca do 18 godina ista je mg/kg doza kao i za odrasle, tj. 6,25 mg po kilogramu tjelesne težine svakih 6 sati.
English: 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.
Croatian: To znači da zbog male učestalosti ove bolesti i zbog etičkih razloga nije bilo moguće provesti placebom kontrolirana klinička ispitivanja i dobiti potpune informacije o ovom lijeku.
English: A controlled randomised prophylaxis study (Study 2004-000592-33) was conducted in the paediatric patients undergoing HSCT.
Croatian: Kontrolirano randomizirano ispitivanje profilaktičke primjene (ispitivanje 2004-000592-33) provedeno je u pedijatrijskih bolesnika podvrgnutih transplantaciji hematopoetskih matičnih stanica.
English: • haemothorax (accumulation of blood in the area between the heart and the lung)
Croatian: • hemotoraks (nakupljanje krvi u predjelu između srca i pluća)
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.
Croatian: Istodobna sistemska antikoagulacijska terapija (npr. heparin, varfarin, izravni inhibitori trombina i izravni inhibitori faktora Xa) (vidjeti dio 4.5), osim za rutinsko održavanje ili ponovno otvaranje središnje venske linije, zahtijeva pažljivo nadziranje.
English: • bleeding from the infusion line
Croatian: • krvarenje iz linije za infuziju
English: Patients (n=356) were randomised to receive 25 mg/kg/day from the start of conditioning or were randomised to receive no prophylaxis.
Croatian: Bolesnici (n=356) su bili randomizirani u skupinu koja je primala 25 mg/kg na dan od početka liječenja ili u skupinu koja nije primala profilaksu.
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).
Croatian: U pivotalnom ispitivanju liječenja faze 3 (ispitivanje 2005-01), sveukupna incidencija štetnih događaja bila je slična u skupini liječenoj defibrotidom i u kontrolnoj skupini (na temelju povijesnih kontrola).
English: 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%).
Croatian: Nakon primjene terapijske doze (6,25 mg/kg) u zdravih ispitanika, u prosjeku 9,48% ukupne primijenjene doze izlučuje se u urinu kao defibrotid u neizmijenjenom obliku u roku od 24 sata, a veći dio se izlučio tijekom prvog razdoblja prikupljanja uzorka od 0-4 sata (približno 98%).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 October 2013
Croatian: Datum prvog odobrenja: 18. listopada 2013.
English: There are no studies investigating the effects of defibrotide on human fertility.
Croatian: Nisu provedena ispitivanja o učinku defibrotida na plodnost u ljudi.
English: A bolus administration of Defitelio may cause flushing or a sensation of “generalised heat”.
Croatian: Primjena lijeka Defitelio u bolusu može izazvati navale crvenila ili osjećaj “generalizirane vrućine”.
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.
Croatian: U sekundarnim analizama na podskupini bolesnika koji su bili podvrgnuti alogenetskim transplantacijama, profilaksa lijekom Defitelio bila je također povezana s nižom incidencijom i manje slučajeva stupnja težine 2 do 4 akutne reakcije presatka protiv primatelja (aGvHD) do dana+100.
English: 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.
Croatian: Pri dozama višim od preporučene doze od 25 mg/kg na dan, udio bolesnika s krvarenjima bio je veći u skupini koja je primala visoku dozu, ali budući da su se mnogi štetni događaji dogodili u razdoblju praćenja, jasna povezanost s liječenjem defibrotidom nije se mogla ustanoviti.
English: Do not use Defitelio
Croatian: Nemojte primjenjivati Defitelio
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).
Croatian: Radi prikupljanja usporednih sigurnosnih podataka, nositelj odobrenja dostavit će završno Izvješće o kliničkom ispitivanju i Izvješće o usporednim sigurnosnim podacima iz prilagodljivog randomiziranog ispitivanja faze 3 (15-007) defibrotida u odnosu na najbolje potporne mjere u prevenciji venookluzivne bolesti jetre u odraslih i pedijatrijskih bolesnika koji se podvrgavaju transplantaciji hematopoetskih matičnih stanica.
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').
Croatian: • Drugi sastojci su natrijev citrat dihidrat, kloridna kiselina i natrijev hidroksid (oboje za podešavanje pH) i voda za injekcije (vidjeti dio 2 „Defitelio sadrži natrij”).
English: 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.
Croatian: Koristi se za liječenje stanja koje se naziva veno-okluzivna bolest jetre, a koja nastaje kada krvne žile u jetri postaju oštećene i začepljene krvnim ugrušcima.
English: Forty-four children and 58 adult patients with severe VOD post-HSCT, were treated with Defitelio 25 mg/kg/day intravenous by infusion, and compared with 32 historical control patients.
Croatian: Četrdeset i četvero djece i 58 odraslih bolesnika s teškom veno-okluzivnom bolešću nakon transplantacije hematopoetskih matičnih stanica, liječeni su intravenskom infuzijom lijeka Defitelio 25 mg/kg na dan i uspoređeni su sa 32 povijesne kontrole.
English: If a dose of Defitelio has been forgotten
Croatian: Ako je zaboravljena doza lijeka Defitelio:
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.
Croatian: Podaci o ishodima za 611 transplantiranih bolesnika s ne-teškom i teškom veno-okluzivnom bolesti koji su liječeni lijekom Defitelio na osnovi milosrdne primjene lijeka u skladu su s podacima iz kontroliranih kliničkih ispitivanja, uz stopu potpunih odgovora od 24% (51/212) i preživljenje od 37% (78/212) u podskupini bolesnika s teškom veno-okluzivnom bolešću.
English: Defibrotide is an oligonucleotide mixture with demonstrated antithrombotic, fibrinolytic, anti-adhesive and anti-inflammatory actions.
Croatian: Defibrotid je mješavina oligonukleotida s dokazanim antitrombotskim, fibrinolitičkim, antiadhezivnim i protuupalnim djelovanjem.
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).
Croatian: Obavijestite svog liječnika ako uzimate lijekove za sprječavanje nastanka krvnih ugrušaka, kao što su acetilsalicilatna kiselina, heparini, varfarin, dabigatran, rivaroksaban ili apiksaban ili ako uzimate lijekove protiv upale (npr. ibuprofen, naproksen, diklofenak i druge nesteroidne protuupalne lijekove).
English: Defitelio has no or negligible influence on the ability to drive and operate machines.
Croatian: Defitelio ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: This medicine can be used in adults, and in adolescents, children and infants over one month of age.
Croatian: Ovaj lijek se može koristiti u odraslih i adolescenata, u djece te dojenčadi starije od mjesec dana.
English: 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:
Croatian: Nakon jednokratne doze lijeka Defitelio od 6,25 mg/kg primijenjene u 52 zdrava dobrovoljca u obliku infuzije tijekom 2 sata, farmakokinetički parametri bili su sljedeći:
English: There are no studies using defibrotide in pregnant women.
Croatian: Nisu provedena ispitivanja s primjenom defibrotida u trudnica.
English: This means that due to the rarity of the disease and for ethical reasons preventing to perform a placebo-controlled study, it has not been possible to obtain complete information on this medicinal product.
Croatian: To znači da s obzirom na malu učestalost bolesti i zbog etičkih razloga koji sprječavaju provedbu placebom kontroliranog ispitivanja nije bilo moguće doći do potpunih informacija o ovom lijeku.
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.
Croatian: Najčešće nuspojave opažene tijekom primjene lijeka zbog veno-okluzivne bolesti jetre bile su hemoragija (uključujući ali ne ograničavajući se samo na gastrointestinalnu hemoragiju, plućnu hemoragiju i epistaksu) i hipotenzija.
English: Pharmacokinetic modelling simulation analysis showed that Defitelio plasma concentrations do not accumulate upon multiple dose administration and with doses up to 4-fold the therapeutic dose.
Croatian: Analiza simulacije farmakokinetičkog modeliranja pokazala je da se koncentracije lijeka Defitelio ne akumuliraju u plazmi pri višestrukim dozama te dozama do 4 puta većim od terapijske doze.
English: • bleeding in general
Croatian: • krvarenje općenito
English: Defitelio should not be used if the solution is cloudy or contains particles.
Croatian: Defitelio se ne smije primjenjivati ako je otopina zamućena ili sadrži čestice.
English: 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.
Croatian: U ispitivanjima reprodukcije Segment II u štakora i kunića, defibrotid je pokazao maternalnu toksičnost uzrokujući visoku stopu hemoragijskih pobačaja kada je davan intravenskom infuzijom tijekom dva sata pri svim testiranim dozama, uključujući one slične ljudskoj dozi.
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.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadrži 80 mg defibrotida* što odgovara količini od 200 mg u bočici od 2,5 ml te koncentraciji u rasponu od 4 mg/ml do 20 mg/ml nakon razrjeđivanja.
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).
Croatian: Značajno veći udio bolesnika u skupini liječenoj lijekom Defitelio postigao je potpuni odgovor definiran kao ukupni bilirubin manji od 2 mg/dl i prestanak multiorganskog zatajenja; potpuni odgovor na dan+100 iznosio je 23,5% (24/102) uz Defitelio naspram 9,4% (3/32) u povijesnoj kontrolnoj skupini (p=0,013).
English: • bleeding at the site of injection
Croatian: • krvarenje na mjestu primjene injekcije
English: One mL of concentrate contains 80 mg defibrotide.
Croatian: Jedan ml koncentrata sadrži 80 mg defibrotida.
English: Also contains: sodium citrate dihydrate, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections
Croatian: Sadrži također: natrijev citrat dihidrat, kloridnu kiselinu i natrijev hidroksid (za podešavanje pH), vodu za injekcije
English: 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.
Croatian: Lijekove koji utječu na agregaciju trombocita (npr. nestereoidni protuupalni lijekovi), treba za vrijeme primjene lijeka Defitelio primjenjivati pažljivo i pod pomnim medicinskim nadzorom.
English: Accumulation of defibrotide over 4 doses was not found.
Croatian: Nije bilo nakupljanja defibrotida tijekom 4 doze.
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.
Croatian: Međutim, dokazana je kemijska i fizikalna stabilnost lijeka u primjeni od 72 sata pri temperaturi od 15 do 25°C za raspon koncentracija od 4 mg/ml do 20 mg/ml u 0,9%-tnoj otopini natrijeva klorida (9 mg/ml) za infuziju ili 5%-tnoj otopini glukoze za infuziju pri temperaturi od 15 do 25ºC u trajanju od 72 sata.
English: • The active substance is defibrotide.
Croatian: • Djelatna tvar je defibrotid.
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.
Croatian: Pokazalo se smanjenje od 40% u sveukupnoj incidenciji veno-okluzivne bolesti u skupini koja je primala profilaksu lijekom Defitelio (od 19,9% u kontrolnoj skupini do 12,2% u skupini koja je primala Defitelio).
English: Survival by Day+100
Croatian: Preživljenje na dan+100
English: Piazza XX Settembre, 2 22079 Villa Guardia (Como) Italy
Croatian: Piazza XX Settembre, 2 22079 Villa Guardia (Como) Italija
English: * produced from porcine intestinal mucosa.
Croatian: * proizvedeno iz crijevne mukoze svinja
English: It is not known whether defibrotide is excreted in human milk.
Croatian: Nije poznato izlučuje li se defibrotid u majčino mlijeko.
English: Complete Response by Day+100
Croatian: Potpuni odgovor do dana+100
English: It primarily acts through reducing excessive endothelial cell (EC) activation (endothelial dysfunction), modulating endothelial homeostasis as well as restoring thrombo-fibrinolytic balance.
Croatian: Defibrotid prvenstveno djeluje putem smanjenja prekomjerne aktivacije endotelnih stanica (endotelne disfunkcije), mijenjanja endotelne homeostaze i ponovne uspostave trombo-fibrinolitičke ravnoteže.
English: Defitelio is for intravenous use.
Croatian: Defitelio je namijenjen za intravensku primjenu.
English: Adverse reactions observed are listed below, by system organ class and frequency.
Croatian: Opažene nuspojave navedene su u nastavku, razvrstane prema klasifikaciji organskih sustava i učestalosti.
English: The efficacy data from this pivotal study are supported and confirmed with data from a dose-finding study (25 mg/kg arm) and the Open Label Treatment-IND study, as presented in Tables 1.
Croatian: Podaci o djelotvornosti iz tog pivotalnog ispitivanja poduprti su i potvrđeni podacima ispitivanja u svrhu određivanja optimalne doze (skupina liječena sa 25 mg/kg) te otvorenog ispitivanja liječenja novim lijekom (IND), kao što je prikazano u tablici 1.
English: Defibrotide works by protecting the cells of the blood vessels and preventing or breaking down the blood clots.
Croatian: Defibrotid djeluje tako da štiti stanice krvnih žila i sprječava nastanak krvnih ugrušaka ili razgrađuje krvne ugruške.
English: Defibrotide is not removed by dialysis (see section 5.2).
Croatian: Defibrotid se ne uklanja dijalizom (vidjeti dio 5.2).
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).
Croatian: Na mišjem modelu tromboembolije, rekombinantni t-PA pojačao je antitrombotski učinak defibrotida kada je davan intravenski pa stoga istodobna primjena može predstavljati povećani rizik od hemoragije te je kontraindicirana (vidjeti dio 4.3).
English: How you will be given Defitelio
Croatian: Kako će Vam primjenjivati Defitelio
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).
Croatian: In vitro, defibrotid pokazuje protuupalne učinke koji smanjuju oslobađanje i stvaranje reaktivnih kisikovih radikala i upalnih medijatora, kao što su interleukin 6, tromboksan A2, leukotrien B4 i faktor nekroze tumora α (TNF-α).