FrancophonIA/ELRC3.0 huggingface dataset:
English: Wound infection
Slovenian: okužba rane
English: Powder 2 g
Slovenian: prašek 2 g
English: NexoBrid must be stored upright to keep the gel at the bottom of the bottle and in the original package to protect from light.
Slovenian: Zdravilo NexoBrid shranjujte pokončno, da ostane gel na dnu steklenice, in v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: • The need for wound cleansing and preparation before treatment with o Application of a dressing soaked with an antibacterial solution for two hours before NexoBrid application o Protection of surrounding skin areas
Slovenian: • Potreba po čiščenju rane in pripravi pred zdravljenjem z o nanosom obloge namočene v antibakterijsko raztopino za dve uri, pred nanosom zdravila Nexobrid o zaščito okoliških področij kože
English: • Within 15 minutes of mixing, NexoBrid must be applied topically to the burn wound, at a thickness of 1.5 to 3 millimetres.
Slovenian: • V roku 15 minut od mešanja morate zdravilo NexoBrid topikalno nanesti na opeklinsko rano z debelino plasti 1,5 do 3 milimetre.
English: NexoBrid powder Ammonium sulphate Acetic acid
Slovenian: NexoBrid prašek amonijev sulfat ocetna kislina
English: Direct contact of NexoBrid with the eyes should be avoided.
Slovenian: Preprečite neposredni stik zdravila NexoBrid z očmi.
English: Pack size of 1 vial of powder and 1 bottle of gel.
Slovenian: Velikost pakiranja 1 viala s praškom in 1 steklenička z gelom.
English: The paraffin layer must not come into contact with the area to be treated in order to avoid covering the eschar, thus isolating the eschar from direct contact with NexoBrid.
Slovenian: Parafinska plast ne sme priti v stik s predelom, ki ga želite zdraviti, da ne prekrije eshar in prepreči, da bi prišle v neposredni stik z zdravilom NexoBrid.
English: Preparation of patient and wound area
Slovenian: Priprava bolnika in predela rane
English: To prevent possible irritation of abraded skin by inadvertent contact with NexoBrid and possible bleeding from the wound bed, acute wound areas such as lacerations or escharotomy incisions should be protected by a layer of a sterile fatty ointment or fatty dressing (e.g. petrolatum gauze).
Slovenian: Da preprečite možno draženje odrgnjene kože zaradi nenamernega stika z zdravilom NexoBrid in morebitno krvavenje iz posteljice rane, je na rani akutna področja, kot so raztrganine ali esharotomne zareze, treba zaščititi s plastjo sterilnega mastnega mazila ali z mastno oblogo (npr. z gazo z vazelinom).
English: (mean ± SD) Time to complete wound closure (time from ICF**) Number of patients Days to closure of last wound (mean ± SD) Time to successful eschar removal Number of patients Days (mean ± SD) from injury Days (mean ± SD) from consent Patients not reported to have successful eschar removal Measured at first session, if there was more than one surgery session.
Slovenian: SD) Čas do popolnega zaprtja rane (čas od PRS**) Število bolnikov Dnevi do zaprtja zadnje rane (povprečje ± SD) Čas do uspešne odstranitve eshar Število bolnikov Dnevi (povprečje ± SD) od poškodbe Dnevi (povprečje ± SD) od prostovoljnega soglasja Bolniki, pri katerih niso poročali o uspešni odstranitvi eshar 1 Izmerjeno pri prvi obravnavi, če je bilo kirurških obravnav več.
English: In addition, a delayed-type allergic skin reaction (cheilitis) after longer-term dermal exposure (mouthwash) as well as suspected sensitisation following oral exposure and following repeated occupational airway exposure have been reported.
Slovenian: Poleg tega so poročali o zakasnelih alergijskih kožnih reakcijah (heilitis) po daljši dermalni izpostavljenosti (ustna voda) in o sumu na senzibilizacijo po peroralni izpostavitvi in po večkratni poklicni izpostavljenosti dihalnih poti.
English: Removal of NexoBrid
Slovenian: Odstranjevanje zdravila NexoBrid
English: In studies where analgesia was provided in NexoBrid-treated patients on an on-demand basis, local pain was reported in 23.3% of patients treated with NexoBrid and in 11.4% of the control patients.
Slovenian: V študijah, kjer so analgetike pri bolnikih, zdravljenih z zdravilom NexoBrid, uporabljali po potrebi, so o lokalni bolečini poročali pri 23,3 % bolnikov, zdravljenih z zdravilom NexoBrid in pri 11,4 % bolnikov iz kontrolne skupine.
English: The powder is off-white to light tan and the gel is clear and colourless.
Slovenian: Prašek je belkast do svetlorjav, gel je prozoren in brezbarven.
English: Breast-feeding should be discontinued at least 4 days from NexoBrid application initiation.
Slovenian: Od uvedbe zdravila NexoBrid je treba za vsaj 4 dni prenehati z dojenjem.
English: In case of skin exposure, NexoBrid must be rinsed off with water.
Slovenian: V primeru izpostavljenosti kože morate zdravilo NexoBrid izpirati z vodo.
English: There are no data from the use of NexoBrid in pregnant women.
Slovenian: Podatkov o uporabi zdravila NexoBrid pri nosečnicah ni.
English: NexoBrid should not be used in chemical burn wounds, contaminated wounds and wounds where NexoBrid could come in contact with foreign materials (for example, implants, pacemakers, and shunts) or large blood vessels, the eyes or other important body parts.
Slovenian: Zdravila NexoBrid ne uporabljajte pri kemičnih opeklinskih ranah, kontaminiranih ranah in ranah, pri katerih lahko zdravilo NexoBrid pride v stik s tujki (na primer vsadki, spodbujevalniki in šanti), velikimi žilami, očmi ali drugimi pomembnimi deli telesa.
English: Cross-sensitivity between bromelain and papain as well as latex proteins (known as latex-fruit syndrome), bee venom, and olive tree pollen has been reported in the literature.
Slovenian: V literaturi poročajo o križni senzibilizaciji med bromelainom in papainom ter beljakovinami lateksa (znan kot sindrom alergije na lateks in sadje), čebeljim strupom in pelodom oljke.
English: • Before application of the grafts or primary dressing, the debrided bed must be cleaned and refreshed by, e.g., brushing or scraping to allow dressing adherence.
Slovenian: • Pred nanosom presadka ali primarnega ovoja je treba očiščeno posteljico rane očistiti in osvežiti, npr. s ščetkanjem ali strganjem, da se obloga sprime.
English: Deep partial-thickness wounds autografted* Number of wounds % of wounds autografted % of wound area autografted (mean ± SD)
Slovenian: Globoke dermalne rane z avtotransplantatom* Število ran % ran z avtotransplantatom % predela ran z avtotransplantatom (povprečje ± SD)
English: Powder 5 g
Slovenian: prašek 5 g
English: As in the case of surgically debrided bed, in order to prevent desiccation and/or formation of pseudoeschar and/or infection, the debrided area should be covered immediately by temporary or permanent skin substitutes or dressings.
Slovenian: Kot pri kirurško čiščeni opeklinski rani je treba očiščeni predel za zaščito pred izsušitvijo in/ali nastankom psevdoeshar in/ali okužb takoj prekriti z začasnimi ali stalnimi kožnimi nadomestki ali oblogami.
English: NexoBrid should be used with caution in patients with disorders of coagulation, low platelet counts and increased risk of bleeding from other causes e.g. peptic ulcers and sepsis.
Slovenian: Zdravilo NexoBrid je treba pri bolnikih z motnjami koagulacije, nizkim številom trombocitov in povečanim tveganjem zaradi drugih razlogov, npr. želodčnih čirov in sepse, uporabljati previdno.
English: Gel for NexoBrid 2 g
Slovenian: gel za zdravilo NexoBrid 2 g
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable.>
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Navedba smiselno ni potrebna.>
English: How NexoBrid is used
Slovenian: Kako se uporablja zdravilo NexoBrid
English: Store upright to keep the gel at the bottom of the bottle and in the original package to protect from light.
Slovenian: Shranjujte pokončno, da ostane gel na dnu steklenice, in v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Cutaneous use.
Slovenian: Dermalna uporaba.
English: This usually requires mixing the NexoBrid powder and the gel for 1 to 2 minutes.
Slovenian: Običajno je treba zdravilo NexoBrid prašek in gel mešati 1 do 2 minuti.
English: • Within 15 minutes of mixing, NexoBrid must be applied topically to the moistened burn wound, at a thickness of 1.5 to 3 millimetres.
Slovenian: • Po mešanju morate v roku 15 minut zdravilo NexoBrid topikalno nanesti na navlaženo opeklinsko rano z debelino plasti 1,5 do 3 milimetre.
English: Children and adolescents NexoBrid is not for use in patients younger than 18 years.
Slovenian: Otroci in mladostniki Zdravilo NexoBrid ni primerno za uporabo pri bolnikih, mlajših od 18 let.
English: Avoid accidental eye exposure.
Slovenian: Preprečite nezgodno izpostavitev očes.
English: - If you get any side effects, talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
English: 65428 Rüsselsheim Germany
Slovenian: 65428 Rüsselsheim Nemčija
English: NexoBrid is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.
Slovenian: Zdravilo NexoBrid je indicirano za odstranitev eshar pri odraslih z globokimi dermalnimi in subdermalnimi termalnimi opeklinami.
English: *The endpoint can only be evaluated for deep partial-thickness wounds without full-thickness areas because full-thickness burns always require grafting.
Slovenian: *Ta končna točka je bila ocenjena le za globoke dermalne opekline, saj je treba pri subdermalnih opeklinah vedno uporabiti presadek.
English: Allergic reactions can cause, for example, breathing difficulties, swelling of the skin, hives, other skin reactions, redness of the skin, low blood pressure, fast heart rate and abdominal discomfort, or a combination of such effects.
Slovenian: Alergijske reakcije lahko na primer povzročijo težave z dihanjem, kožne otekline, koprivnico, druge kožne reakcije, rdečino kože, nizek krvni tlak, hitro bitje srca in nelagodje v trebuhu ali kombinacijo teh učinkov.
English: Gel for NexoBrid 5 g
Slovenian: gel za zdravilo NexoBrid 5 g
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 6.7%, 7.8% and 8.9% of patients, respectively.
Slovenian: V skupini z zdravilom NexoBrid so bili dogodki ocenjeni kot blagi pri 6,7 %, zmerni pri 7,8 % in hudi pri 8,9 % bolnikov.
English: Autografted wounds (ITT)
Slovenian: Rane z avtotransplantatom (ITT)
English: Gel for NexoBrid powder
Slovenian: Gel za zdravilo NexoBrid prašek
English: • Other medicines (such as silver sulfadiazine or povidone-iodine) will be removed from the wound area before NexoBrid is applied.
Slovenian: • Druga zdravila (kot sta srebrov sulfadiazin ali povidon-jod) vam bodo pred nanosom zdravila NexoBrid odstranili s predela rane.
English: • The powder is then transferred into the corresponding gel bottle.
Slovenian: • Prašek nato prenesite v ustrezno stekleničko z gelom.
English: NexoBrid was well tolerated when applied to intact mini-pig skin but caused severe irritation and pain when applied to damaged (abraded) skin.
Slovenian: Pri nanosu zdravila NexoBrid na nepoškodovano kožo mini-prašičkov so zdravilo dobro prenašali, vendar je pri nanosu na poškodovano (abradirano) kožo povzročilo hudo draženje in bolečine.
English: Excipients: Acetic acid, ammonium sulphate.
Slovenian: Pomožne snovi: ocetna kislina, amonijev sulfat.
English: - cause an unwanted drop in blood pressure when you are treated with medicines called ACE inhibitors, which are used to treat high blood pressure and other conditions.
Slovenian: - okrepi vašo reakcijo na zdravili proti raku fluorouracilu in vinkristinu, - povzroči neželen padec krvnega tlaka, če se zdravite z zdravili, imenovanimi zaviralci ACE, ki se uporabljajo za zdravljenje visokega krvnega tlaka in drugih bolezni.
English: In the other patients, dose-normalised Cmax ranged from 141-523 ng/ml per gram of NexoBrid.
Slovenian: Pri ostalih bolnikih je bil razpon Cmax, normaliziran na odmerek, od 141-523 ng/ml na gram zdravila NexoBrid.
English: • You will be given appropriate medicine to prevent and treat pain at least 15 minutes before NexoBrid is applied.
Slovenian: • Vsaj 15 minut pred nanosom zdravila NexoBrid boste prejeli ustrezna zdravila za preprečevanje in zdravljenje bolečine.
English: Allergic reactions to NexoBrid can occur and can cause, for example, breathing difficulties, swelling of the skin, hives, redness of the skin, low blood pressure, fast heart rate and sickness/vomiting/stomach cramp, or a combination of such effects.
Slovenian: Alergijske reakcije na zdravilo NexoBrid lahko na primer povzročijo težave z dihanjem, kožne otekline, koprivnico, rdečino kože, nizek krvni tlak, hitro bitje srca in siljenje na bruhanje/bruhanje/trebušne krče ali kombinacijo teh učinkov.
English: These events included: Wound deepening or desiccation (decomposition) in 5 patients (2.4%) with NexoBrid and 0 with SOC as well as (partial) graft failure in 6 patients (2.9%) with NexoBrid and 2 (1.6%) with SOC (see section 4.4).
Slovenian: Ti dogodki so vključevali: Poglobitev ali izsušitev (dekompozicija) rane pri 5 bolnikih (2,4 %) z zdravilom NexoBrid in 0 s standardno nego ter (delno) odpoved presadka pri 6 bolnikih (2,9 %) z zdravilom NexoBrid ter 2 (1,6 %) s standardno nego (glejte poglavje 4.4).
English: These events included: wound deepening or desiccation (decomposition) in 5 patients (2.4%) with NexoBrid and 0 with SOC as well as (partial) graft failure in 6 patients (2.9%) with NexoBrid and 2 (1.6%) with SOC (see section 4.4).
Slovenian: Ti dogodki so vključevali: poglobitev ali izsušitev (dekompozicija) rane pri 5 bolnikih (2,4 %) z zdravilom NexoBrid in 0 s standardno nego ter (delno) odpoved presadka pri 6 bolnikih (2,9 %) z zdravilom NexoBrid ter 2 (1,6 %) s standardno nego (glejte poglavje 4.4).
English: • The powder vial must be opened by carefully tearing off the aluminium cap and removing the rubber stopper.
Slovenian: • Vialo s praškom morate previdno odpreti, tako da odtrgate aluminijasto zaporko in odstranite gumijasti zamašek.
English: - Signs of local or systemic allergic reactions.
Slovenian: driska), - znake lokalnih ali sistemskih alergijskih reakcij, - možnega učinka na hemostazo (glejte zgoraj).
English: The co-primary endpoints for the efficacy analysis were: - the percentage of deep partial thickness wounds requiring excision or dermabrasion, and - the percentage of deep partial thickness wounds autografted.
Slovenian: Sočasni opazovani dogodki za analizo učinkovitosti so bili: - odstotek globokih dermalnih ran, ki jih je bilo treba naknadno čistiti z ekscizijo ali dermabrazijo, in - odstotek globokih dermalnih ran, oskrbljenih z avtotransplantati.
English: Allergic reactions to bromelain include anaphylactic reactions and other immediate-type reactions with manifestations such as bronchospasm, angiooedema, urticaria, and mucosal and gastrointestinal reactions.
Slovenian: Alergijske reakcije na bromelain vključno anafilaktične reakcije in druge takojšnje reakcije s pojavnimi oblikami, kot so bronhospazem, angioedem, urtikarija in reakcije sluznice in prebavil.
English: Use in patients with cardiopulmonary and pulmonary disease NexoBrid should be used with caution in patients with cardiopulmonary and pulmonary disease, including pulmonary burn trauma and suspected pulmonary burn trauma.
Slovenian: Zdravilo NexoBrid je treba pri bolnikih z boleznijo src in pljuč ali boleznijo pljuč, vključno s poškodbami pljuč zaradi opeklin in sumom na poškodbe pljuč zaradi opeklin uporabiti previdno.
English: • After NexoBrid and the dead tissue have been removed from the wound, a dressing soaked with an antibacterial solution will be applied for an additional 2 hours.
Slovenian: • Po odstranitvi zdravila NexoBrid in mrtvega tkiva z rane vam bodo na rano za 2 uri položili oblogo, namočeno z antibakterijsko raztopino.
English: No studies were performed to assess the effects of NexoBrid on fertility.
Slovenian: Študij za ocenitev učinka zdravila NexoBrid niso opravili.
English: 1 vial of 2 g powder 1 bottle of 20 g of gel
Slovenian: prašek in gel za gel 1 viala z 2 g praška 1 steklenica z 20 g gela
English: Before it is applied to a burn wound, NexoBrid powder is mixed into a gel.
Slovenian: Preden se zdravilo NexoBrid prašek nanese na opeklinsko rano, se morate prašek zmešati v gel.
English: • The wound management after NexoBrid treatment with o Application of a dressing soaked with an antibacterial solution for two hours o Performance of grafting procedures as soon as possible after debridement
Slovenian: • Oskrba rane po zdravljenju z zdravilom NexoBrid z o nanosom obloge, namočene v antibakterijsko raztopino za dve uri o izvedba postopka avtotransplantacije takoj, ko je možno po čiščenju
English: What NexoBrid is
Slovenian: Kaj je zdravilo NexoBrid
English: 1 vial of 5 g powder 1 bottle of 50 g of gel
Slovenian: prašek in gel za gel 1 viala s 5 g praška 1 steklenica s 50 g gela
English: - you have a heart disease; - you have a lung disease; - your lung has been, or may have been damaged by inhalation of smoke;
Slovenian: - če imate bolezen srca; - če imate bolezen pljuč; - če so vaša pljuča poškodovana ali so morda bila poškodovana zaradi vdihavanja dima; - če že imate alergijo na lateks, čebelji pik ali pelod oljke, boste morda imeli alergijsko reakcijo na zdravilo NexoBrid:
English: Gentle pressing of the occlusive dressing at the area of contact with the adhesive barrier will ensure adherence between the occlusive film and the sterile adhesive barrier and achieve complete containment of NexoBrid on the treatment area.
Slovenian: Z nežnim pritiskom na okluzivno oblogo na predelu stika z adhezivno pregrado je mogoče zagotoviti prileganje okluzivnega filma in sterilne adhezivne pregrade in doseči, da ostane vso zdravilo NexoBrid znotraj zdravljenega predela.
English: Mixed wounds (with partial and full-thickness area) autografted NexoBrid (Number of wounds)
Slovenian: Mešane rane (z dermalnimi in subdermalnimi predeli) z avtotransplantatom Zdravilo NexoBrid (število ran)
English: Allergic reactions to bromelain have been reported in the literature (including anaphylactic reactions and other immediate-type reactions with manifestations such as bronchospasm, angiooedema, urticaria, and mucosal and gastrointestinal reactions).
Slovenian: V literaturi poročajo o alergijskih reakcijah na bromelain (vključno z anafilaktičnimi reakcijami in drugimi takojšnjimi reakcijami s pojavnimi oblikami, kot so bronhospazem, angioedem, urtikarija in reakcije sluznice in prebavil).
English: This should be considered when mixing NexoBrid powder with the gel.
Slovenian: To je treba upoštevati pri mešanju zdravila NexoBrid prašek z gelom.
English: Rare (1/10,000 to <1/1,000)
Slovenian: V nadaljevanju se uporabljajo naslednje navedbe pogostnosti: zelo pogosti (≥ 1/10) pogosti (≥ 1/100 do < 1/10) občasni ( 1/1.000 do < 1/100) redki ( 1/10.000 do < 1/1.000) zelo redki (< 1/10.000) neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: NexoBrid is for use by specialists in burn clinics only.
Slovenian: Zdravilo NexoBrid lahko uporabljajo samo specialisti z izkušnjami pri zdravljenju opeklin.
English: A total wound area of not more than 15% TBSA can be treated with NexoBrid (see also section 4.4, Coagulopathy).
Slovenian: V enem postopku se lahko zdravilo NexoBrid nanese na največ 15 % CPT (glejte tudi poglavje 4.4, Koagulopatija).
English: What NexoBrid is used for
Slovenian: Za kaj se uporablja zdravilo NexoBrid
English: Excipients for the powder: Acetic acid, ammonium sulphate.
Slovenian: Pomožne snovi za prašek: ocetna kislina, amonijev sulfat.
English: When NexoBrid was used in a regimen which included recommended preventive analgesia as routinely practiced for extensive dressing changes in burn patients as well as antibacterial soaking of the treatment area before and after NexoBrid application (see section 4.2), pain was reported in 3.6% of patients, pyrexia/hyperthermia in 19.1% of patients.
Slovenian: Ko so zdravilo NexoBrid uporabljali na način, ki je vključeval priporočene preventivne analgetike, kot je rutinska praksa pri obširni menjavi oblog pri bolnikih z opeklinami in namakanje zdravljenega predela s protibakterijskimi učinkovinami pred nanosom zdravila NexoBrid in po njem (glejte poglavje 4.2), so pri 3,6 % bolnikov poročali o lokalni bolečini, in o pireksiji/hipertermiji pri 19,1 % bolnikov.
English: There is no experience of the use of NexoBrid on: - perineal and genital burns.
Slovenian: Opekline, pri katerih je izkušenj malo oz. izkušenj ni Z uporabo zdravila NexoBrid ni izkušenj pri: - perinealnih in genitalnih opeklinah, - električnih opeklinah.
English: Reduction of platelet aggregation and plasma fibrinogen levels and a moderate increase in partial thromboplastin and prothrombin times have been reported as possible effects following oral administration of bromelain.
Slovenian: Kot o možnih neželenih učinkih po peroralnem dajanju bromelaina so poročali o zmanjšani agregaciji trombocitov in ravni fibrinogenov v plazmi ter zmernem povečanju delnega tromboplastinskega in protrombinskega časa.
English: • Powder and gel must be mixed thoroughly until a uniform, slightly tan to slightly brown mixture is obtained.
Slovenian: • Prašek in gel morate dobro premešati, da dobite enakomerno, rahlo svetlorjavo do rjavkasto mešanico.
English: There is very limited information on the use of NexoBrid on areas where eschar remained after the first application.
Slovenian: Informacij o uporabi zdravila NexoBrid na predelih, kjer so eshare ostale po prvem nanosu, je malo.
English: In the 4 patients with indications of higher absorption, dose-normalised Cmax ranged from 788-900 ng/ml per gram of NexoBrid.
Slovenian: Pri 4 bolnikih z znaki večje absorpcije je bil Cmax, normaliziran na odmerek, v razponu 788-900 ng/ml na gram zdravila NexoBrid.
English: In addition to routine monitoring for burn patients (e.g., vital signs, volume/water/electrolyte status, complete blood count, serum albumin and hepatic enzyme levels), patients treated with NexoBrid should be monitored for: - Rise in body temperature.
Slovenian: Poleg rutinskega spremljanja bolnikov z opeklinami (npr. vitalni znaki, status prostornine/vode/elektrolitov, celotna krvna slika, ravni albumina v serum in jetrnega encima), je treba bolnike, ki se zdravijo z zdravilom NexoBrid, spremljati tudi za: - povečanje telesne temperature, - znake lokalnih in sistemskih vnetnih in kužnih procesov, - stanja, ki bi jih lahko povzročilo ali poslabšalo premediciranje z analgetiki (npr. dilatacija želodca, navzea in tveganje nenadnega bruhanja, zaprtost) ali antibiotična profilaksa (npr.
English: In studies where the NexoBrid regimen included recommended preventive analgesia as routinely practiced for extensive dressing changes in burn patients (see section 4.2) local pain was reported in 3.6% of patients treated with NexoBrid and in 4.0% of the control patients treated according to standard of care.
Slovenian: V študijah, kjer je način uporabe zdravila NexoBrid vključeval priporočene preventivne analgetike, ki se pri menjavi velikih površin oblog pri bolnikih z opeklinami uporabljajo rutinsko (glejte poglavje 4.2), so pri 3,6 % bolnikov, zdravljenih z zdravilom NexoBrid, in pri 4,0 % bolnikov iz kontrolne skupine, zdravljenih s standardno nego, poročali o lokalni bolečini.
English: • Wounds with areas of full-thickness and deep burn should be autografted as soon as possible after NexoBrid debridement.
Slovenian: • Na rane s predeli globokih in subdermalnih opeklin je treba presaditi avtotransplantate takoj, ko je mogoče po čiščenju z zdravilom NexoBrid.
English: Posology 5 g NexoBrid powder in 50 g gel is applied to a burn wound area of 250 cm
Slovenian: Zdravilo NexoBrid 5 g prašek, vmešan 50 g gel se nanese na predel opeklinske rane površine 250 cm
English: In case of eye exposure, exposed eyes must be irrigated with copious amounts of water for at least 15 minutes.
Slovenian: Če pride do izpostavitve, morate izpostavljene oči vsaj 15 minut izpirati z veliko vode.
English: There is no information on the use of NexoBrid in patients with renal impairment.
Slovenian: Ni podatkov o uporabi zdravila NexoBrid pri bolnikih z okvaro ledvic.