natgillin/translations-raw huggingface dataset:
The European Medicines Agency has deferred the obligation to submit the results of studies with NexoBrid in one or more subsets of the paediatric population in the treatment of burns of external body surface (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom NexoBrid za eno ali več podskupin pediatrične populacije za zdravljenje opeklin zunanje površine telesa (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
NexoBrid showed no genotoxic activity when investigated in the standard set of in vitro and in vivo studies. 
Zdravilo NexoBrid ni pokazalo genotoksične aktivnosti pri raziskavah v standardnem nizu študij in vitro in in vivo.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V
This is to make it less likely that you develop an allergic reaction to NexoBrid. 
To je potrebno, da se zmanjša verjetnost razvoja alergijske reakcije na zdravilo NexoBrid.
- If you have any further questions, ask your doctor. 
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom.
Efficacy data generated in this study for all age groups combined as well as from a subgroup analysis for children and adolescents are summarised below. 
Podatki o učinkovitosti za to študijo za vse starostne skupine skupaj in za analize podskupin za otroke in mladostnike so povzeti spodaj.
The MAH should undertake a controlled distribution of NexoBrid to ensure that the product is not available for use at a centre until at least one surgeon at the centre has received formal training in the use of NexoBrid. 
Imetnik dovoljenja za promet z zdravilom mora za zdravilo NexoBrid izvajati sistem nadzorovane distribucije, da zagotovi, da zdravilo v centru ne bo na voljo, dokler vsaj en kirurg iz tega centra ne opravi formalnega izobraževanja o uporabi zdravila NexoBrid.
• The limitation of the total area than can be treated to 15% TBSA 
• Omejitev skupne površine, ki jo je dovoljeno zdraviti, je 15 % CPT
In several cases adequate healing did not occur and autografting was required at a later date, leading to significant delays in wound closure which is associated with increased risk of wound-related complications. 
V številnih primerih ni prišlo do ustrezne zacelitve, zato je bilo kasneje predel treba prekriti z avtotransplantatom, kar je znatno upočasnilo zapiranje rane, ki je povezano z večjim tveganjem za zaplete, povezane z rano.
After treatment with NexoBrid your doctor may check your blood coagulation levels. 
Po zdravljenju z zdravilom NexoBrid lahko vaš zdravnik preveri, kako se vaša kri strjuje.
The MAH shall conducts a study on enzymatic debridement in burns patients (children and adults): A comparison to standard of care (protocol MW2010-0302), based on a CHMP approved protocol. 
Imetnik dovoljenja za promet z zdravilom bo opravil študijo encimskega čiščenja ran pri bolnikih z opeklinami (otroci in odrasli): Primerjava s standardno nego (protokol MW2010-03-02), na podlagi protokola, ki ga je odobril CHMP.
Pharmacotherapeutic group: Preparations for treatment of wounds and ulcers, proteolytic enzymes; ATC code: D03BA03 
Farmakoterapevtska skupina: pripravki za zdravljenje ran in razjed, proteolitični encimi; oznaka ATC: D03BA03
NexoBrid powder (vial) 
NexoBrid prašek (viala)
The comparisons in mixed wounds should be interpreted with caution since they are based on groups that are not fully randomized and the mixed wounds treated by NexoBrid were overall larger and had a larger full thickness area. 
Primerjavo mešanih ran je treba razlagati previdno, saj temeljijo na skupinah, ki niso povsem randomizirane; mešane rane, zdravljene z zdravilom NexoBrid pa so bile na splošno večje in so imele večje prizadete subdermalne predele.
• The need for pain management 
• Potreba po protibolečinskemu zdravljenju
The potential of NexoBrid (a protein product) to cause sensitisation should be taken into account when re-exposing patients to bromelain-containing products at a later point in time. 
Potencial zdravila NexoBrid (beljakovinski izdelek), da povzroči senzibilizacijo, je treba upoštevati pri ponovni kasnejši izpostavitvi bolnikov izdelkom, ki vsebujejo bromelain.
This should be taken into account when dosing such products. 
To je treba upoštevati pri odmerjanju teh zdravil.
If there is a risk of eye contact, the patient's eyes should be protected with fatty ophthalmic ointment. 
Če obstaja tveganje za stik z očmi, morate bolnikove oči zaščititi z mastnim oftalmičnim mazilom.
The age range in the group treated with NexoBrid was 4.4 to 55.7 years. 
Razpon starosti v skupini, zdravljeni z zdravilom NexoBrid, je bil 4,4 do 55,7 let.
Bromelain may increase drowsiness caused by some medicinal products (e.g., benzodiazepines, barbiturates, narcotics and antidepressants). 
Bromelain lahko poveča zaspanost, ki jo povzročijo nekatera zdravila (npr. benzodiazepini, barbiturati, narkotiki in antidepresivi).
NexoBrid serum concentrations were determined using a modified sandwich electrochemiluminescence (ECL) immunoassay. 
Koncentracije zdravila NexoBrid v serumu so določali z modificiranim elektrokemiluminescentnim (ECL) sendvič-imunotestom.
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP). 
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Hypersensitivity to the active substance, to pineapples or papain (see also section 4.4), or to any of the excipients listed in section 6.1. 
Preobčutljivost na zdravilno učinkovino, ananas ali papain (glejte tudi poglavje 4.4), ali katero koli pomožno snov, navedeno v poglavju 6.1.
NexoBrid, when absorbed, is an inhibitor of cytochrome P 450 2C8 (CYP2C8) and P450 2C9 (CYP2C9). 
Ko se zdravilo NexoBrid absorbira, je zaviralec citokroma P 450 2C8 (CYP2C8) in P 450 2C9 (CYP2C9).
• The risk of allergic reaction and of cross reactivity and the contraindication in patients allergic to pineapple and papain or to previous application of the product 
• Tveganje za pojav alergijskih reakcij in navzkrižnih reakcij ter kontraindikacije pri bolnikih, alergičnih na ananas in papain ali na predhodni nanos zdravila
During the clinical development of NexoBrid, there was no indication of an increased bleeding tendency or bleeding at the site of debridement. 
Med kliničnim razvojem zdravila NexoBrid ni bilo znakov povečane nagnjenosti h krvavitvam ali krvavitve na mestu čiščenja.
Powder and gel to be mixed before application. 
Prašek in gel je treba pred uporabo premešati.
What you need to know before NexoBrid is used 
Kaj morate vedeti, preden se uporabi zdravilo NexoBrid
A Cmax of 40µg/ml may be possible in humans administered NexoBrid under licensed conditions, when it is considered that PK has only been evaluated in patients with largely superficial burns, receiving half the maximum dose. 
Cmax 40 µg/ml je lahko mogoč pri osebah, ki prejmejo zdravilo NexoBrid v okviru pogojev odobrene uporabe, pri čemer se upošteva, da je bila farmakokinetika ocenjena le pri bolnikih z velikimi površinskimi opeklinami, ki so prejeli polovični največji odmerek.
What NexoBrid is and what it is used for 
Kaj je zdravilo NexoBrid in za kaj ga uporabljamo
According to a literature report, in plasma, approximately 50% of bromelain binds to the human plasma antiproteinases α2-macroglobulin and α1-antichymotrypsin. 
V literaturi poročajo, da se v plazmi približno 50 % bromelaina veže na antiproteazi α2-makroglobulin in α1-antihimotripsin v plazmi pri človeku.
During clinical development, a total of 362 patients were treated with the concentrate of proteolytic enzymes enriched in bromelain. 
Med kliničnim razvojem so skupaj 362 bolnikov zdravili s koncentratom proteolitičnih encimov, obogatenih z bromelainom.
This is because NexoBrid can be absorbed from the burn wound into the blood stream. 
To je zato, ker se lahko zdravilo NexoBrid absorbira iz opeklin v krvni obtok.
PHARMACEUTICAL FORM AND CONTENT 
FARMACEVTSKA OBLIKA IN VSEBINA
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation is in place and functioning before and whilst the medicinal product is on the market. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The extent of systemic absorption from a burn wound, Cmax, Tmax, AUC, and t½ of bromelain from NexoBrid have been investigated in 16 burn patients with partial-thickness (mid- and deep-dermal) thermal burns. 
Obseg sistemske absorpcije iz opeklinske rane, Cmax, Tmax, AUC in t½ bromelaina iz zdravila NexoBrid so raziskali pri 16 bolnikih z dermalnimi (srednjimi in globokimi) opeklinskimi ranami.
48 wounds 
48 ran
• The dressing must remain in place for 4 hours. 
• Obloga mora ostati na rani 4 ure.
60 wounds 
60 ran
Therefore, wounds with areas of full-thickness and deep burn should be autografted as soon as possible after NexoBrid debridement (see section 5.1 for study results). 
Zato je treba subdermalne in globoke opekline po čiščenju z zdravilom NexoBrid prekriti z avtotransplantatom takoj, ko je možno (za rezultate študije glejte poglavje 5.1).
Concentrate of proteolytic enzymes enriched in bromelain is systemically absorbed from burn wound areas (see section 5.2). 
Koncentrat proteolitičnih encimov, obogaten z bromelainom, se sistemsko absorbira iz območja opeklinske rane (glejte poglavje 5.2).
Terminal half-life (determined using data from 16 to 48 hours post-dose for 12 patients) was 11.7 ± 3.5 hours (mean ± SD), with a range from 8.5 to 19.9 hours. 
Končni razpolovni čas (ugotovljen s podatki iz 16 do 48 ur po odmerku za 12 bolnikov) je bil 11,7 ± 3,5 ure (povprečje ± SD), z razponom od 8,5 do 19,9 ure.
D-48155 Münster Germany 
D-48155 Münster Nemčija
General Infections 
Splošne okužbe
<Not applicable.> 
<Navedba smiselno ni potrebna.>
Standard of care consisted of primary surgical excision and/or nonsurgical debridement using topical medicinal products to induce maceration and autolysis of eschar according to each study site's standard practice. 
Standardna nega je bila primarna kirurška ekscizija in/ali nekirurško čiščenje s topikalnimi zdravili za induciranje maceracije in avtolize eshar v skladu s standardno prakso vsake lokacije študije.
Repeated intravenous injections of doses up to 12 mg/kg every third day in the mini-pig were well tolerated for the first three injections but severe clinical signs of toxicity (e.g. haemorrhages in several organs) were observed following the remaining three injections. 
Ponavljajoče se intravensko injiciranje odmerkov do 12 mg/kg vsak tretji dan so mini-prašički dobro prenašali prve tri injekcije, nato pa so pri ostalih treh injekcijah opazili hude klinične znake toksičnosti (npr. krvavitev številnih organov).
• The wound must then be covered with a sterile occlusive film dressing that adheres to the sterile adhesive barrier material applied as per the instruction above (see Preparation of patient and wound area). 
• Rano morate nato prekriti s sterilno okluzivno filmsko oblogo, ki se zalepi na sterilni adhezivni pregradni material, nanesen v skladu z navodili zgoraj (glejte Priprava bolnika in predela rane).
The effect on the timing of eschar removal was evaluated in patients with successful eschar removal (with at least 90% eschar removal in all wounds of a patient combined), by determining the time from injury as well as from informed consent to successful removal. 
Učinek na čas odstranitve eshar so ocenili pri bolnikih z uspešno odstranitvijo eshar (z vsaj 90odstotno odstranitvijo eshar v vseh ranah bolnika skupaj), z določitvijo časa od poškodbe in od zavestnega soglasja za uspešno odstranitev.
Serious allergic reactions including anaphylaxis 
resne alergijske reakcije, vključno z anafilakso
NexoBrid gel preparation (mixing powder with gel) 
Priprava zdravila NexoBrid gel (mešanje praška z gelom)
The proteolytic enzymes are a mixture of enzymes from the stem of Ananas comosus (pineapple plant). 
Proteolitični encimi so mešanica encimov iz stebla rastline Ananas comosus (rastlina ananasa).
Immune system disorders Not known: 
lokalna bolečina* Bolezni imunskega sistema Neznana:
What NexoBrid is and what it is used for What you need to know before NexoBrid is used How NexoBrid is used 
Kaj je zdravilo NexoBrid in za kaj ga uporabljamo Kaj morate vedeti, preden se uporabi zdravilo NexoBrid Kako se uporablja zdravilo NexoBrid Možni neželeni učinki
This usually requires mixing the powder and the gel for 1 to 2 minutes. 
Običajno je treba prašek in gel mešati 1 do 2 minuti.
This should be taken into account if NexoBrid is used in patients receiving CYP2C8 substrates (including amiodarone, amodiaquine, chloroquine, fluvastatin, paclitaxel, pioglitazone, repaglinide, rosiglitazone, sorafenib and torasemide) and CYP2C9 substrates (including ibuprofen, tolbutamide, glipizide, losartan, celecoxib, warfarin, and phenytoin). 
To je treba upoštevati, če se zdravilo NexoBrid uporablja pri bolnikih, ki prejemajo substrate CYP2C8 (vključno z amiodaronom, amodiakinom, klorokvinom, fluvastatinom, paklitakselom, pioglitazonom, repaglinidom, rosiglitazonom, sorafenibom in torazemidom) in substrati CYP2C9 (vključno z ibuprofenom, tolbutamidom, glipizidom, losartanom, celekoksibom, varfarinom in fenitoinom).
• The removal of NexoBrid and of dissolved eschar 
• Odstranitev zdravila NexoBrid in odpuščenih eshar
ITT (Intent To Treat population): all randomized patients The difference in time to complete wound closure is mainly related to the wound care strategy applied by the physician, where an attempt to minimise grafting and allow for spontaneous epithelialisation of the wound areas that still have dermis may prolong time to first autograft (time to autograft: NexoBrid: 14.7 days vs. SOC: 5.9 days) and hence prolong complete wound closure. 
ITT (populacija z namenom zdravljenja (Intent To Treat population)): vsi randomizirani bolniki Razlika v času do popolnega zaprtja rane je v glavnem povezana s strategijo nege rane, ki jo uporabi zdravnik, pri čemer lahko poskus zmanjšanja presaditev in omogočenja spontane epitelializacije predela rane s kožo podaljša čas do prvega avtotransplantata (čas do avtotransplantata: zdravilo NexoBrid: 14,7 dni v primerjavi s standardno nego: 5,9 dni) in s tem podaljša popolno zaprtje rane.
Due to safety considerations (see also section 4.4, Coagulopathy) NexoBrid should not be applied to more than 15%Total Body Surface Area (TBSA). 
Zaradi varnostnih pomislekov (glejte tudi poglavje 4.4, Koagulopatija) zdravila NexoBrid ne nanašajte na več kot 15 % celotne površine telesa (CPT).
Days (mean ± SD) (Number of wounds) 
Število dni (povprečje ± SD) (število ran)
The use of NexoBrid in subsequent burn injury is not recommended. 
Kasnejše uporabe zdravila NexoBrid za nadaljnje opeklinske rane se ne priporoča.
The use of NexoBrid to remove burnt tissue may lead to fever, to wound inflammation or wound infection, and possibly to general infection. 
Uporaba zdravila NexoBrid za odstranjevanje opečenega tkiva lahko povzroči povišano telesno temperaturo, vnetje rane ali okužbo rane, morda pa tudi splošno okužbo.
Animal studies are insufficient to properly assess the potential of NexoBrid to interfere with embryonal/foetal development (see section 5.3). 
Ni dovolj študij na živalih za pravilno oceno možnosti vpliva zdravila NexoBrid na razvoj zarodka ali plodu (glejte poglavje 5.3).
60% of the treated wounds area was partial thickness and/or full thickness. 
60 % zdravljenih predelov so bile dermalne in/ali subdermalne opeklinske rane.
Other medicines and NexoBrid Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero katero koli drugo zdravilo.
Topically applied antibacterial medicinal products (e.g. silver sulfadiazine or povidone iodine) may decrease the efficacy of NexoBrid (see section 4.4). 
Topikalno nanesena protibakterijska zdravila (kot sta srebrov sulfadiazin ali povidon-jod) lahko zmanjšajo učinkovitost zdravila NexoBrid (glejte poglavje 4.4).
Store and transport refrigerated (2C-8C). 
Zdravilo shranjujte in prevažajte v hladnem (2 C - 8 C).
• The vial containing NexoBrid powder, gel bottle, and the prepared NexoBrid gel should only be used for one patient. 
• Vialo, ki vsebuje zdravilo NexoBrid prašek, stekleničko z gelom in pripravljeno zdravilo NexoBrid gel, lahko zdravnik uporabi samo za enega bolnika.
• After 4 hours of NexoBrid treatment, the occlusive dressing must be removed using aseptic techniques. 
• Po 4 urah zdravljenja z zdravilom NexoBrid morate okluzivno oblogo odstraniti z aseptično tehniko.
Cmax was 6020 ± 5020 ng/ml (mean ± SD) for the group of 15 patients, with a range of 888 to 15,700 ng/ml. 
Cmax je bil 6.020 ± 5.020 ng/ml (povprečje ± SD) za skupino 15 bolnikov, z razponom 888 do 15.700 ng/ml.
Common side effects (may affect up to 1 in 10 people) - Pain (even if medicines are used to prevent or lessen pain caused by the removal of burnt tissue) - Infection of the burn wound - Complications of the wound including; wound opening, wounds drying out and breaking down and failure of skin grafts to heal properly 
Pogosti neželeni učinki (prizadenejo lahko največ 1 od 10 bolnikov) - bolečina (tudi ob uporabi zdravil za preprečevanje ali blaženje bolečine, ki jo povzroči odstranjevanje opečenega tkiva) - okužba opeklinske rane - zapleti z rano, vključno z odprtjem rane, izsušitvijo rane in raztrganjem ali neustreznim celjenjem kožnih presadkov
There is limited pharmacokinetic data in patients with TBSA of more than 15%. 
Pri bolnikih z opeklinami na več kot 15 % CPT so farmakokinetični podatki omejeni.
• The gel should be prepared at the patient's bedside. 
• Gel morate pripraviti ob bolnikovi postelji.
To prevent wound-healing problems, the treated burn wound will be covered as soon as possible by temporary or permanent skin substitutes or dressings. 
Da preprečite težave s celjenjem rane, bo obdelana opeklinska rana takoj, ko je mogoče, prekrita z začasnim ali stalnim kožnim nadomestkom ali oblogo.
The AUC from time zero to 48 hours after administration (AUClast) was 43,400 ± 46,100 ngh/ml (mean ± SD) for the group of 15 patients, with a range of 4560-167,000 ngh/ml. 
AUC od časa nič do 48 ur po uporabi (AUClast) je bil 43.400 ± 46.100 ngh/ml (povprečje ± SD) za skupino 16 bolnikov, z razponom 4.560-167.000 ngh/ml.
Each NexoBrid vial, gel, or reconstituted gel should be used for a single patient only. 
Vsako vialo zdravila NexoBrid gel ali rekonstituiranega gela uporabite samo za enega bolnika.
• When opening the gel bottle, it must be confirmed that the tamper-evident ring is separating from the bottle's cap. 
• Pri odpiranju stekleničke z gelom morate preveriti, da se je varnostni obroček ločil od zaporke steklenice.
Rubbing will not remove adhering undissolved eschar in areas where the eschar still remains. 
Z drgnjenjem ne boste odstranili neodluščenih eshar na predelih, kjer so ostale.
• The NexoBrid powder and gel are sterile. 
• Zdravilo NexoBrid prašek in gel sta sterilna.
If the tamper-evident ring was already separated from the cap before opening, the gel bottle must be discarded and another, new gel bottle used. 
Če je bil varnostni obroček že odtrgan od zaporke, preden ste jo odprli, morate steklenico z gelom zavreči in uporabite drugo, novo steklenico z gelom.
Cross-sensitivity 
Križna senzibilizacija
Benefit/risk assessment should include consideration of the greater frequency of concomitant disease or other medicinal product therapy in the elderly. 
Pri oceni razmerja med koristmi in tveganjem je treba upoštevati, da je pri starejših bolnikih pogostnost sočasnih obolenj ali sočasnega zdravljenja z drugimi zdravili večja.
NexoBrid may reduce the ability of your blood to form clots, which increases the risk of bleeding. 
Zdravilo NexoBrid lahko zmanjša sposobnost strjevanja krvi in s tem poveča tveganje za krvavitev.
NexoBrid should be used with caution if you have a general tendency to bleed, a stomach ulcer, blood poisoning, or another condition that could cause you to bleed. 
Zdravilo NexoBrid je treba uporabljati previdno, če ste na splošno nagnjeni h krvavitvam, razjedi želodca, zastrupitvi krvi ali drugim stanjem, ki lahko povzročijo krvavitev.
It is unknown whether concentrate of proteolytic enzymes enriched in bromelain or its metabolites are excreted in human milk. 
Ni znano, ali se koncentrat proteolitičnih encimov, obogaten z bromelainom, ali njegovi presnovki izločajo v materino mleko.
NexoBrid may: - increase the effects of certain medicines that are inactivated by a liver enzyme called CYP2C8 and CYP2C9. 
Zdravilo NexoBrid lahko: - poveča učinke nekaterih zdravil, ki jih jetrna encima, imenovana CYP2C8 in CYP2C9, deaktivirata.
Since the safe use of NexoBrid during pregnancy has not yet been established, NexoBrid is not recommended during pregnancy. 
Ker varnosti uporabe zdravila NexoBrid med nosečnostjo še niso dokazali, zdravila NexoBrid ne uporabljajte pri nosečnicah.
No interaction studies with NexoBrid have been performed. 
Študij medsebojnega delovanja z zdravilom NexoBrid niso izvedli.
In NexoBrid studies wounds with visible dermal remnants were allowed to heal by spontaneous epithelialisation. 
V študijah z zdravilom NexoBrid so pustili, da so se rane z vidnimi ostanki kože zacelile s spontano epitelializacijo.
The gel is clear and colourless. 
Gel je prozoren in brezbarven.
• The debrided area must be covered immediately by temporary or permanent skin substitutes or dressings to prevent desiccation and/or formation of pseudoeschar and/or infection. 
• Očiščen predel morate takoj prekriti z začasnim kožnim nadomestkom ali stalnim kožnim presadkom ali oblogo, da se ne osuši in/ali ne nastanejo psevdoeshare in/ali okužbe.
In studies without antibacterial soaking, pyrexia or hyperthermia was reported in 35.6% of NexoBridtreated patients compared with 18.6% in control patients. 
V študijah brez antibakterijskega namakanja so o pireksiji ali hipertermiji poročali pri 35,6 % bolnikov, zdravljenih z zdravilom NexoBrid, v primerjavi z 18,6 % bolnikov iz kontrolne skupine.
The efficacy of NexoBrid in humans was evaluated, compared to standard of care, in a randomised, multi-centre, multi-national, open-label, confirmatory phase 3 study in hospitalised patients with deep partial- and/or full-thickness thermal burns of 5 to 30% Total Body Surface Area (TBSA), but with total burn wounds of no more than 30% TBSA. 
Učinkovitost zdravila NexoBrid pri ljudeh je bila ocenjena glede na standardno nego v randomizirani, multicentričini, multinacionalni, odprti, potrditveni študiji 3. faze pri hospitaliziranih bolnikih z globokimi dermalnimi in subdermalnimi opeklinami 5 do 30 % celotne površine telesa (CPT) in s skupnimi opeklinskimi ranami do 30 % CPT.
Non-autografted wounds (ITT) 
Rane brez avtotransplantata (ITT)
In phase 2 and phase 3 clinical studies, certain types of wound complications were reported more frequently in the NexoBrid group than in the group treated according to the study sites' Standard of Care (SOC). 
V kliničnih študijah 2. in 3. faze so o nekaterih vrstah zapletov z rano poročali pogosteje v skupini z zdravilom NexoBrid, kot pri skupini, zdravljeni v skladu s standardno terapijo.