FrancophonIA/ELRC3.0 huggingface dataset:
English: Volume of distribution is around 10 L. In vitro studies demonstrate that 93% of Defitelio is bound to plasma proteins.
Slovenian: Prostornina porazdelitve je približno 10 l. Študije in vitro so pokazale, da se 93 % zdravila Defitelio veže na beljakovine v plazmi.
English: Marketing Authorisation Holder and Manufacturer Gentium Srl
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Gentium Srl
English: Use of medicinal products that increase the risk of haemorrhage within 24 hours of Defitelio administration (within 12 hours in the case of unfractionated heparin) is not recommended.
Slovenian: Uporaba zdravil, ki povečajo tveganje krvavitve, v 24 urah po uporabi zdravila Defitelio (v 12 urah pri nefrakcioniranem heparinu) ni priporočljiva.
English: The treatment with Defitelio can be initiated and continuously supervised only by an experienced doctor in a hospital or in a specialised centre for stem cells transplantation.
Slovenian: Zdravljenje z zdravilom Defitelio lahko uvede in stalno nadzoruje samo izkušen zdravnik v bolnišnici ali specializiranem centru za presaditev matičnih celic.
English: Median length of therapy in those treated with Defitelio was 22 days.
Slovenian: Mediana trajanja zdravljenja bolnikov, zdravljenih z zdravilom Defitelio, je bila 22 dni.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 10 vials
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 10 vial
English: There is no specific antidote for overdose and treatment should be symptomatic.
Slovenian: Za preveliko odmerjanje ni posebnega antidota, zato mora biti zdravljenje simptomatsko.
English: Macrophages are considered the main target organ.
Slovenian: Domnevajo, da so makrofagi glavni tarčni organ.
English: However, if used, in exceptional cases, caution should be exercised by closely monitoring the coagulation parameters (see section 4.4).
Slovenian: Če pa se sočasno uporabljajo v izjemnih primerih, je treba biti previden in skrbno spremljati parametre koagulacije (glejte poglavje 4.4).
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).
Slovenian: Učinkovitost in varnost defibrotida pri zdravljenju hude VOB so preučevali v ključni, zgodovinsko nadzorovani študiji 3. faze (2005-1).
English: * produced from porcine intestinal mucosa.
Slovenian: * Izdelanega iz prašičje črevesne sluznice.
English: • if you have heavy bleeding and need a blood transfusion
Slovenian: • če imate močno krvavitev, ki zahteva transfuzijo krvi;
English: Preparation of Defitelio (use aseptic technique):
Slovenian: Priprava zdravila Defitelio (z aseptično tehniko):
English: For adverse reactions reported in both studies, the highest frequency was used in the table below.
Slovenian: Za neželene učinke, o katerih so poročali v obeh študijah, je v spodnji preglednici uporabljena njihova največja pogostnost.
English: The treatment should be administered for a minimum of 21 days and continued until the symptoms and signs of severe VOD resolve.
Slovenian: Zdravilo je treba uporabljati najmanj 21 dni, zdravljenje pa mora trajati, dokler simptomi in znaki hude VOB ne izginejo.
English: • coagulopathy (disturbance of blood clotting)
Slovenian: • koagulopatija (motnja strjevanja krvi),
English: It is not known whether defibrotide is excreted in human milk.
Slovenian: Ni znano, ali se defibrotid izloča v materino mleko.
English: The concentrate solution for infusion has to be diluted using aseptic technique.
Slovenian: Koncentrat za raztopino za infundiranje je treba razredčiti z aseptično tehniko.
English: These data are from an open label registry and the subjects were not randomised.
Slovenian: Ti podatki izhajajo iz odprtega registra, pri katerem preskušanci niso bili naključno razporejeni.
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.
Slovenian: Po redčenju za uporabo čas shranjevanja infuzije ne sme preseči 24 ur pri temperaturi 2-8 °C, razen če je bilo redčenje opravljeno pri nadzorovanih in validiranih aseptičnih pogojih.
English: Pack size of 10 vials.
Slovenian: Velikost pakiranja: 10 vial.
English: The frequency nature and severity of adverse reactions in children are otherwise the same as in adults.
Slovenian: Pogostnost in resnost neželenih učinkov pri otrocih sta enaki kot pri odraslih.
English: Defibrotide does not inhibit or induce CYP450s.
Slovenian: Defibrotid ne zavira in ne inducira encimov CYP450.
English: Pharmacotherapeutic group: other antithrombotic agents; ATC code: B01AX01.
Slovenian: Farmakoterapevtska skupina: Druge antitrombotične učinkovine, oznaka ATC: B01AX01 Mehanizem delovanja
English: Do not use Defitelio after the expiry date which is stated on the carton and vial label after EXP.
Slovenian: Zdravila Defitelio ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznake »EXP«.
English: It primarily acts through reducing excessive endothelial cell (EC) activation (endothelial dysfunction), modulating endothelial homeostasis as well as restoring thrombo-fibrinolytic balance.
Slovenian: Primarno deluje tako, da zmanjša pretirano aktivacijo endotelijskih celic (EC) (endotelijska disfunkcija), modulira endotelijsko hemostazo, pa tudi obnavlja trombo-fibrinolitično ravnovesje.
English: Vials are intended for a single use and unused solution from a single dose must be discarded (see section 6.6)
Slovenian: Viale so namenjene enkratni uporabi, zato je treba neporabljeno raztopino iz enkratnega odmerka zavreči (glejte poglavje 6.6).
English: Adverse reactions observed are listed below, by system organ class and frequency.
Slovenian: Spodaj so navedeni opaženi neželeni učinki glede na organski sistem in pogostnost.
English: *=Kaplan Meier estimates for time-to-event analysis by Day100
Slovenian: * Kaplan-Meierjeve ocene za analizo časa do dogodka do 100.+ dneva.
English: OTHER 200 mg/2.5 mL Gentium Srl
Slovenian: DRUGI PODATKI 200 mg/2.5 mL Gentium Srl
English: The safety data from the pivotal study are supported and confirmed with data from the completed Treatment-IND study.
Slovenian: Podatke o varnosti iz ključne študije podpirajo in potrjujejo podatki iz končane študije T-IND.
English: Defitelio should always be diluted prior to use.
Slovenian: Zdravilo Defitelio je treba pred uporabo vedno razredčiti.
English: Defibrotide works by protecting the cells of the blood vessels and preventing or breaking down the blood clots.
Slovenian: Defibrotid deluje tako, da zaščiti celice krvnih žil in prepreči ali razgradi krvne strdke.
English: 2.5 mL vials (Type I clear glass), closed with a stopper (butyl rubber) and seal (aluminium).
Slovenian: 2,5-mililitrske viale (prozorno steklo tipa I), zaprte z zamaškom (butilna guma) in tesnilom (aluminij).
English: Accumulation of defibrotide over 4 doses was not found.
Slovenian: Kopičenja defibrotida po 4 odmerkih niso ugotovili.
English: The required volume from the Defitelio vials should be withdrawn and combined.
Slovenian: Izvleči je treba potrebno prostornino zdravila Defitelio in jo združiti.
English: There are no studies investigating the effects of defibrotide on human fertility.
Slovenian: Študij o učinkih defibrotida na plodnost pri človeku ni.
English: Therefore, the use of defibrotide with antithrombotic/fibrinolytic medicinal products is not recommended.
Slovenian: Uporaba defibrotida z antitrombotičnimi/fibrinolitičnimi zdravili zato ni priporočljiva.
English: It is administered by intravenous infusion, over two hours.
Slovenian: Daje se z intravenskim infundiranjem, ki traja dve uri.
English: The use of Defitelio rescue treatment for all patients who developed VOD meant that the study was not designed to assess any survival advantage and none was seen in this study.
Slovenian: Uporaba reševalnega zdravljenja z zdravilom Defitelio pri vseh bolnikih, pri katerih se je razvila VOB, pomeni, da študija ni bila zasnovana za ocenjevanje kakršne koli prednosti pri preživetju, česar tudi niso opazili.
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.
Slovenian: Umrljivost zaradi vseh vzrokov pri bolnikih s hudo VOB, ki se niso zdravili z defibrotidom, je bila 100.+ dan 69-odstotna, pri bolnikih, ki so prejemali defibrotid, pa 61-odstotna.
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.
Slovenian: Podatke o učinkovitosti iz te ključne študije podpirajo in potrjujejo podatki iz študije za ugotavljanje odmerka (skupina s 25 mg/kg) in podatki iz odprte študije zdravljenja IND, kot je predstavljeno v preglednici 1.
English: • The active substance is defibrotide.
Slovenian: • Učinkovina je defibrotid.
English: Administration of defibrotide to patients who have haemodynamic instability, defined as inability to maintain mean arterial pressure with single pressor support, is not recommended.
Slovenian: Uporaba defibrotida pri bolnikih s hemodinamsko nestabilnostjo, opredeljeno kot nezmožnost vzdrževanja povprečnega arterijskega tlaka ob podpori z enim presorjem, ni priporočljiva.
English: Defitelio may be used during breastfeeding.
Slovenian: Zdravilo Defitelio se lahko uporablja med dojenjem.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be expected to exceed 24 hours at 2-8°C.
Slovenian: Če se zdravilo ne porabi takoj, je uporabnik odgovoren za čas in pogoje shranjevanja pred uporabo, to pa ne bi smelo trajati dlje kot 24 ur pri temperaturi 2-8 C.
English: Only clear solutions without visible particles should be used.
Slovenian: Uporabiti smete samo prozorno raztopino brez vidnih delcev.
English: For patients treated with Defitelio the following side effects were reported.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Defitelio, so poročali o naslednjih neželenih učinkih.
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.
Slovenian: Na podlagi rezultatov študije QTc, opravljene pri zdravih preskušancih s terapevtskimi in supraterapevtskimi odmerki, lahko sklepamo, da zdravilo Defitelio nima statistično ali klinično pomembnega potenciala za podaljšanje QTc pri odmerkih, do 4-krat večjih od terapevtsko indiciranih.
English: In patients who have or develop clinically significant acute bleeding requiring blood transfusion, Defitelio is not recommended or should be discontinued.
Slovenian: Pri bolnikih, ki imajo klinično pomembno akutno krvavitev, ki zahteva krvno transfuzijo, zdravilo Defitelio ni priporočljivo ali pa je treba njegovo uporabo prekiniti.
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.
Slovenian: Morebitne interakcije z antitrombotičnimi fibrinolitičnimi učinkovinami Defibrotid ima profibrinolitičen učinek (glejte poglavje 5.1), kar lahko okrepi delovanje antitrombotičnih/fibrinolitičnih zdravil.
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.
Slovenian: Štiriinštirideset otrok in 58 odraslih bolnikov s hudo VOB po PKMC so zdravili z zdravilom Defitelio v odmerku 25 mg/kg/dan, danim intravensko z infundiranjem, potem pa so jih primerjali z 32 zgodovinskimi kontrolnimi bolniki.
English: What you need to know before you take Defitelio
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Defitelio
English: It is recommended that the diluted Defitelio solution be administered to patients using an infusion set equipped with a 0.2 μm in-line filter.
Slovenian: Priporočljivo je, da razredčeno raztopino zdravila Defitelio bolnikom aplicirate s kompletom za infundiranje, opremljenim z vgrajenim 0,2-μm filtrom.
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.
Slovenian: To pomeni, da zaradi redkosti bolezni in iz etičnih razlogov, ki so preprečili izvajanje s placebom nadzorovane študije, ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: The number of vials to be diluted should be determined based on the individual patient's weight (see section 4.2).
Slovenian: Število vial, ki jih je treba razredčiti, je treba določiti na podlagi posameznikove telesne mase (glejte poglavje 4.2).
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).
Slovenian: Poleg tega se je po 100.+ dnevu izboljšal delež preživetja v skupini z zdravilom Defitelio, v kateri je preživelo 38,2 % bolnikov (39/102), v primerjavi z zgodovinsko kontrolno skupino z deležem 25,0 % (8/32) (p = 0,034).
English: Patients (n=356) were randomised to receive 25 mg/kg/day from the start of conditioning or were randomised to receive no prophylaxis.
Slovenian: Bolniki (n = 356) so bili naključno razporejeni v skupino, ki je prejemala 25 mg/kg/dan od začetka priprav, ali v skupino brez profilakse.
English: Defitelio must be prescribed and administered to patients by specialised physicians experienced in the diagnosis and treatment of complications of HSCT.
Slovenian: Zdravilo Defitelio mora bolnikom predpisati in dajati specialist z izkušnjami z diagnosticiranjem ter zdravljenjem zapletov PKMC.
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.
Slovenian: V pediatrični preventivni študiji z odmerkom 25 mg/kg/dan so opazili povečano pojavnost katerih koli dogodkov krvavitve v skupini z defibrotidom v primerjavi s skupino, ki se je zdravila.
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.
Slovenian: Priporočeni odmerek pri otrocih, starih od 1 meseca do 18 let, je enak odmerku na osnovi mg/kg kot pri odraslih, tj. 6,25 mg/kg telesne mase vsakih 6 ur.
English: Defitelio is for intravenous use.
Slovenian: Zdravilo Defitelio je za intravensko uporabo.
English: • localized blood collection out of the vessel (hematoma) in the brain
Slovenian: • lokalizirano nabiranje krvi zunaj žile (hematom) v možganih,
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.
Slovenian: Sočasno zdravljenje s sistemskimi antikoagulanti (npr. heparinom, varfarinom, direktnimi zaviralci trombina in direktnimi zaviralci faktorja Xa) (glejte poglavje 4.5), z izjemo rednega vzdrževanja ali vnovičnega odpiranja centralne venske linije, zahteva skrbno spremljanje.
English: Side effects in children (1 month to 18 years old) are expected to be similar in type, severity and frequency and no other special precautions are needed.
Slovenian: Pričakovano je, da bodo vrsta, resnost in pogostnost neželenih učinkov pri otrocih (od 1 meseca do 18 let) podobni kot pri odraslih, zato niso potrebni nobeni drugi posebni previdnostni ukrepi.
English: Defibrotide is an oligonucleotide mixture with demonstrated antithrombotic, fibrinolytic, anti-adhesive and anti-inflammatory actions.
Slovenian: Defibrotid je mešanica oligonukleotidov z dokazanim antitrombotičnim, fibrinolitičnim, antiadhezivnim in protivnetnim delovanjem.
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).
Slovenian: 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).
English: Piazza XX Settembre, 2 22079 Villa Guardia (Como) Italy
Slovenian: Piazza XX Settembre, 2 22079 Villa Guardia (Como) Italija
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.
Slovenian: 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.
English: However, patients would not be expected to drive or operate machinery due to the nature of the underlying disease.
Slovenian: Kljub temu se od bolnikov pričakuje, da zaradi narave osnovne bolezni ne bodo vozili in upravljali s stroji.
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.
Slovenian: 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.
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.
Slovenian: 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.
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).
Slovenian: 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).
English: The recommended dose is 6.25 mg/kg body weight every 6 hours (25 mg/kg/day).
Slovenian: Priporočeni odmerek je 6,25 mg/kg telesne mase vsakih 6 ur (25 mg/kg/dan).
English: Other medicines and Defitelio
Slovenian: Druga zdravila in zdravilo Defitelio
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%).
Slovenian: 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 %).
English: Defitelio should not be used during pregnancy unless the clinical condition of the woman requires treatment with Defitelio.
Slovenian: Zdravilo Defitelio ne smete uporabljati med nosečnosti , razen če klinično stanje ženske zahteva zdravljenje z zdravilom Defitelio.
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).
Slovenian: − Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1; − sočasna uporaba trombolitične terapije (npr. t-PA) (glejte poglavje 4.5).
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).
Slovenian: 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).
English: This medicine can be used in adults, and in adolescents, children and infants over one month of age.
Slovenian: To zdravilo se lahko uporablja pri odraslih in mladostnikih, otrocih ter dojenčkih, starejših od enega meseca.
English: Defitelio has no or negligible influence on the ability to drive and operate machines.
Slovenian: Zdravilo Defitelio nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Defitelio should not be used if the solution is cloudy or contains particles.
Slovenian: Zdravilo Defitelio se ne sme uporabljati, če je motno ali vsebuje delce.
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.
Slovenian: 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).
English: Due to this maternal toxicity, no conclusion can be drawn regarding the effects of defibrotide on embryo-foetal development.
Slovenian: Zaradi toksičnosti za mater ni mogoče sklepati glede učinkov defibrotida na razvoj zarodka/ploda.
English: One carton contains 10 glass vials with 2.5 mL of concentrate each.
Slovenian: Škatla vsebuje 10 steklenih vial z 2,5 ml koncentrata.
English: 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.
Slovenian: 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.
English: Do not use Defitelio
Slovenian: Ne uporabljajte zdravila Defitelio
English: No dose adjustment is therefore recommended but careful monitoring of patients should be undertaken (see section 5.2).
Slovenian: Prilagajanje odmerka zato ni potrebno, vendar pa je treba bolnike skrbno spremljati (glejte poglavje 5.2).
English: A bolus administration of Defitelio may cause flushing or a sensation of “generalised heat”.
Slovenian: Uporaba zdravila Defitelio v obliki bolusa lahko povzroči vročinske oblive ali občutek »splošnega pregrevanja«.
English: • haemothorax (accumulation of blood in the area between the heart and the lung)
Slovenian: • hemotoraks (kopičenje krvi v predelu med srcem in pljuči),