FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Kod ponavljane primjene doze do 12 mg/kg intravenskom injekcijom svakog trećeg dana, patuljaste svinje dobro su podnijele prve tri injekcije, ali nakon sljedeće tri injekcije opaženi su klinički znakovi teške toksičnosti (npr. krvarenje u nekoliko organa).
English: Efficacy data generated in this study from a subgroup analysis for children and adolescents are summarised below.
Croatian: Podaci o djelotvornosti dobiveni iz ovog ispitivanja iz analiza podskupina za djecu i adoelscente sažeti su u nastavku.
English: PHARMACEUTICAL FORM AND CONTENT
Croatian: OBLIK I SADRŽAJ
English: 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).
Croatian: Nositelj odobrenja će provoditi ispitivanja i dodatne aktivnosti predviđene Farmakovigilancijskim planom, kako je dogovoreno RMP-om prikazanim u Modulu 1.8.2 odobrenja za stavljanje gotovog lijeka u promet te sve daljnje dopune RMP-a dogovorene od strane Povjerenstva za humane lijekove (CHMP).
English: Removal of topically applied antibacterial medicinal products before NexoBrid application
Croatian: Uklanjanje topikalno primijenjenih antibakterijskih lijekova prije primjene NexoBrida
English: • NexoBrid gel should be prepared at the patient's bedside.
Croatian: • Gel NexoBrid se mora pripremiti uz krevet bolesnika.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/803/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/803/002
English: 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.
Croatian: Utjecaj vremena na uklanjanje eshara procijenio se u bolesnika u kojih se eshar uspješno uklonio (s najmanje 90% eshara uklonjenog iz svih opeklinskih rana zajedno) određivanjem razdoblja koje je proteklo od ozljede i od informiranog pristanka do uspješnog uklanjanja.
English: • The removal of NexoBrid and of dissolved eschar
Croatian: • Uklanjanje NexoBrida i otopljenog eshara
English: Topically applied antibacterial medicinal products (e.g. silver sulfadiazine or povidone iodine) may decrease the efficacy of NexoBrid (see section 4.4).
Croatian: Topikalno primjenjeni antibakterijski lijekovi (npr. srebro sulfadiazin ili povidon jodid) mogu smanjiti djelotvornost NexoBrida (vidjeti dio 4.4).
English: NexoBrid, when absorbed, is an inhibitor of cytochrome P 450 2C8 (CYP2C8) and P450 2C9 (CYP2C9).
Croatian: P 450 2C8 (CYP2C8) i P450 2C9 (CYP2C9).
English: NexoBrid contains a mixture of enzymes called “concentrate of proteolytic enzymes enriched in bromelain”, which is produced from an extract from the stem of the pineapple plant.
Croatian: NexoBrid sadrži mješavinu enzima zvanih „koncentrat proteolitičkih enzima obogaćenih bromelainom“ koji se proizvodi od ekstrakta stabljike biljke ananasa.
English: Days (mean ± SD) (Number of wounds)
Croatian: Dani (srednja vrijednost ± SD) (broj rana)
English: To prevent wound-healing problems, the treated burn wound will be covered as soon as possible by temporary or permanent skin substitutes or dressings.
Croatian: Za sprječavanje tegoba s cijeljenjem rane, liječena opeklinska rana će se čim prije pokriti privremenim ili trajnim presatkom kože ili povojima.
English: Gel for NexoBrid powder
Croatian: Gel za prašak NexoBrid
English: The proteolytic enzymes are a mixture of enzymes from the stem of Ananas comosus (pineapple plant).
Croatian: Proteolitički enzimi su mješavina enzima ekstrahiranih iz stabljike biljke Ananas comosus (ananasa).
English: There are no data from the use of NexoBrid in pregnant women.
Croatian: Nema podataka o primjeni NexoBrida u trudnica.
English: • 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).
Croatian: • Rana se potom mora prekriti sterilnim okluzivnim filmskim povojem koji prianja za sterilni adhezivni materijal koji se nanio kao barijera prema gornjim uputama (vidjeti Priprema bolesnika i područja rane).
English: NexoBrid is used in adult patients to remove burnt tissue from deep or partially deep burn wounds of the skin.
Croatian: NexoBrid se primjenjuje u odraslih bolesnika za uklanjanje opečenog tkiva iz dubokih ili djelomično dubokih opeklinskih rana kože.
English: 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.
Croatian: AUC u razdoblju od nula do 48 sati nakon primjene (AUCzadnji) iznosio je 43 400 ± 46 100 ngh/ml (srednja vrijednost ± SD) za skupinu od 15 bolesnika, uz raspon od 4560 do 167 000 ngh/ml.
English: 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.
Croatian: Sposobnost NexoBrida (proteinski lijek) da izazove alergijsku senzibilizaciju treba uzeti u obzir kod ponovne kasnije izloženosti bolesnika proizvodima koji sadrže bromelain.
English: In studies without antibacterial soaking, pyrexia or hyperthermia was reported in 35.6% of NexoBridtreated patients compared with 18.6% in control patients.
Croatian: U ispitivanjima bez antibakterijskih obloga pireksija ili hipertermija zabilježena je u 35,6% bolesnika liječenih NexoBridom u usporedbi s 18,6% kontrolnih ispitanika.
English: Eyes should be carefully protected during treatment of facial burns using adhesive barrier petroleum ointment.
Croatian: Tijekom liječenja opeklina lica, oči trebaju biti pažljivo zaštićene koristeći kao adhezivnu barijeru mast na bazi petroleja.
English: 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.
Croatian: NexoBrid treba koristiti oprezno ako imate opću sklonost krvarenju, čir želuca, sepsu ili drugo stanje koje bi moglo uzrokovati krvarenje.
English: INSTRUCTIONS FOR USE
Croatian: 15. UPUTE ZA UPORABU
English: 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.
Croatian: Djelotvornost NexoBrida u ljudi procijenila se u odnosu na standardnu skrb u fazi III randomiziranog, multicentričnog, multinacionalnog potvrdnog ispitivanja otvorenog tipa u hospitaliziranih bolesnika s dubokim termičkim opeklinama djelomične i/ili pune debljine kože koje su zahvaćale 5% do 30% cjelokupne površine tijela, s time da ukupno opečeno područje nije zahvaćalo više od 30% cjelokupne površine tijela.
English: Rubbing will not remove adhering undissolved eschar in areas where the eschar still remains.
Croatian: Trljanjem se neće ukloniti prianjajući, neotopljeni eshar u područjima u kojima će i ostati.
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
Croatian: • Potreba za čišćenjem rane i pripremom prije liječenja o Primjenom zavoja namočenog u otopinu antibakterijskog sredstva tijekom dva sata prije primjene NexoBrida o Zaštita okolnog područja kože
English: The mixture of enzymes in NexoBrid dissolves burn wound eschar.
Croatian: Mješavina enzima u NexoBridu otapa eshar u opeklini.
English: NexoBrid was applied once to the burn wound at a dose of 2 g NexoBrid Powder/20 g gel/100 cm of skin.
Croatian: NexoBrid se primijenio jedanput na opeklinsku ranu u dozi od 2 g NexoBrid praška/20 g gela/100 cm kože.
English: • NexoBrid will be applied to a wound area that is clean, blister free, and moist.
Croatian: • NexoBrid će se nanijeti na područje rane koje je čisto, vlažno i bez mjehura.
English: D-48155 Münster Germany
Croatian: D-48155 Münster Njemačka
English: Deep Partial Thickness wounds
Croatian: Duboke rane djelomične debljine kože
English: Concentrate of proteolytic enzymes enriched in bromelain is a debriding agent, applied topically for removal of eschar in deep partial- and full-thickness burns.
Croatian: Koncentrat proteolitičkih enzima obogaćenih bromelainom topikalno je sredstvo za debridman koje se primjenjuje za uklanjanje eshara u dubokim opeklinama djelomične i/ili pune debljine kože.
English: NexoBrid should only be applied by trained healthcare professionals in specialist burn centres.
Croatian: NexoBrid smiju primjenjivati samo stručni zdravstveni radnici na specijaliziranim odjelima za liječenje opeklina.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA <Not applicable.>
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM Nije primjenjivo.
English: What you need to know before NexoBrid is used
Croatian: Što morate znati prije nego počnete primjenjivati NexoBrid
English: • The vial containing NexoBrid powder, gel bottle, and the prepared NexoBrid gel should only be used for one patient.
Croatian: • Bočica s praškom NexoBrid, boca s gelom i pripremljeni gel NexoBrid smiju se primijeniti samo u jednog bolesnika.
English: • The gel should be prepared at the patient's bedside.
Croatian: • Gel se mora pripremiti uz krevet bolesnika.
English: If NexoBrid goes into the eyes, wash them with lots of water for at least 15 minutes.
Croatian: Ako NexoBrid uđe u oči, ispirite ih obilnom količinom vode najmanje 15 minuta.
English: 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.
Croatian: Standardna skrb sastojala se od primarne kirurške ekscizije i/ili nekirurškog debridementa pomoću topikalnih lijekova kako bi se izazvala maceracija i autoliza eshara, ovisno o standardnoj praksi na pojedinom mjestu ispitivanja.
English: NexoBrid must be used with caution in such patients.
Croatian: U takvih se bolesnika NexoBrid mora primjenjivati s oprezom.
English: 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.
Croatian: Niže su sažeto prikazani podaci o djelotvornosti prikupljeni u ovom ispitivanju u svih dobnih skupina zajedno, kao i analiza podskupina djece i adolescenata.
English: - Signs of local or systemic allergic reactions.
Croatian: - znakova lokalne ili sustavne alergijske reakcije. - mogućih učinaka na hemostazu (vidjeti gore).
English: Gel for NexoBrid 5 g
Croatian: Gel za NexoBrid 5 g
English: A single intravenous infusion of a solution prepared from NexoBrid powder in the mini-pig was well tolerated at dose levels of up to 12 mg/kg (achieving plasma levels 2.5fold of the human plasma level after application of the clinical proposed dosage to 15% TBSA) but higher doses were overtly toxic, causing haemorrhage in several tissues.
Croatian: Patuljaste svinje dobro su podnijele jednokratnu intravensku infuziju otopine pripremljene od praška NexoBrid u dozi do razine od 12 mg/kg (postigavši razine u plazmi 2,5 puta više od razina u ljudskoj plazmi nakon primjene klinički predložene doze na 15% cjelokupne površine tijela), ali više doze bile su očigledno toksične, uzrokujući krvarenje u nekoliko tkiva.
English: Before it is applied to a burn wound, NexoBrid powder is mixed into a gel.
Croatian: Prije nego što se nanese na opeklinu, NexoBrid prašak mora se umiješati u gel.
English: NexoBrid is not indicated for use in patients younger than 18 years.
Croatian: NexoBrid nije indiciran za primjenu u bolesnika mlađih od 18 godina.
English: • After 4 hours of NexoBrid treatment, the occlusive dressing must be removed using aseptic techniques.
Croatian: • Nakon 4 sata liječenja NexoBridom okluzivni povoj mora se ukloniti pomoću aseptičke tehnike.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
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.
Croatian: U literaturi je zabilježena križna osjetljivost između bromelaina i papaina, kao i proteina lateksa (poznata kao sindrom alergije na lateks i voće), pčelinjeg otrova i peludi maslinovog drveta.
English: Gel for NexoBrid 2 g
Croatian: Gel za NexoBrid 2 g
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.
Croatian: Alergijska reakcija može prouzročiti, na primjer, otežano disanje, oticanje kože, koprivnjaču, druge kožne reakcije, crvenilo kože, niski krvni tlak, povećanu brzinu otkucaja srca i nelagodu u trbuhu ili kombinaciju takvih učinaka.
English: NexoBrid gel preparation (mixing powder with gel)
Croatian: Priprema gela NexoBrid (miješanje praška s gelom)
English: MediWound Germany GmbH 65428 Rüsselsheim Germany
Croatian: MediWound Germany GmbH 65428 Rüsselsheim Njemačka
English: • The wound must be cleaned thoroughly and the superficial keratin layer or blisters removed from the wound area, as the keratin will isolate the eschar from direct contact with NexoBrid and prevent eschar removal by NexoBrid.
Croatian: • Rana se mora temeljito očistiti i površinski keratinski sloj ili mjehuri ukloniti s područja rane jer keratin izolira eshar i tako sprječava izravni kontakt s NexoBridom i uklanjanje eshara NexoBridom.
English: There have been reports of serious allergic reactions including anaphylaxis (with manifestations such as rash, erythema, hypotension, tachycardia) in patients undergoing debridement with NexoBrid.
Croatian: Postoje izvješća o ozbiljnim alergijskim reakcijama uključujući anafilaksiju (sa znakovima kao što su osip, eritem, hipotenzija, tahikardija) kod bolesnika koji su podvrgnuti debridmanu s NexoBridom.
English: 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).
Croatian: U fazi II i fazi III kliničkih ispitivanja određene vrste komplikacija rane češće su zabilježene u skupini liječenoj NexoBridom nego u skupini liječenoj prema standardnoj skrbi kakva se primjenjuje na mjestu ispitivanja.
English: The range of total dose applied was 5 to 30 g concentrate of proteolytic enzymes enriched in bromelain from NexoBrid.
Croatian: Ukupna primijenjena doza bila je u rasponu od 5 do 30 g koncentrata proteolitičkih enzima obogaćenih bromelainom iz NexoBrida.
English: It is unknown whether concentrate of proteolytic enzymes enriched in bromelain or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se koncentrat proteolitičkih enzima obogaćen bromelainom ili njegovi metaboliti u majčino mlijeko.
English: Before use, the powder must be mixed with the gel producing a uniform gel.
Croatian: Prije primjene prašak se mora pomiješati s gelom i napraviti jednolični gel.
English: The frequencies of the adverse reactions presented below reflect the use of NexoBrid to remove eschar from deep partial- or full-thickness burns in a regimen with local antibacterial prophylaxis, recommended analgesia, as well as coverage of the wound area after application of NexoBrid for 4 hours with an occlusive dressing for containment of NexoBrid on the wound.
Croatian: Učestalosti niže navedenih nuspojava temelje se na primjeni NexoBrida za uklanjanje eshara iz dubokih opeklina koje zahvaćaju djelomičnu ili punu debljinu kože zajedno s lokalnom antibakterijskom profilaksom, preporučenom analgezijom, kao i pokrivanjem područja rane nakon primjene NexoBrida tijekom 4 sata okluzivnim povojem kako bi se NexoBrid zadržao na rani.
English: Treatment with concentrate of proteolytic enzymes enriched in bromelain prepared in a powder:gel ratio of 1:5 (0.16g per g of mixed gel) in patients with deep partial- and/or full-thickness burns within the framework of a clinical study did not result in significantly different safety findings when compared to treatment with concentrate of proteolytic enzymes enriched in bromelain prepared in a powder:gel ratio of 1:10 (0.09 g per 1g of mixed gel).
Croatian: Liječenje bolesnika s dubokim opeklinama koje zahvaćaju djelomičnu i/ili punu debljinu kože pomoću koncentrata proteolitičkih enzima obogaćenih bromelainom pripremljenima u omjeru praška i gela od 1:5 (0,16 g po gramu zamiješanog gela) u sklopu ispitivanja nije imalo značajno različite rezultate u pogledu sigurnosti primjene u usporedbi s liječenjem koncentratom proteolitičkih enzima obogaćenih bromelainom pripremljenima u omjeru praška i gela od 1:10 (0,09 g po 1 gramu zamiješanog gela).
English: An increase in heart rate (including tachycardia), reduction of platelet aggregation and plasma fibrinogen levels and a moderate increase in partial thromboplastin and prothrombin times have been reported in the literature as possible effects following oral administration of bromelain.
Croatian: Povećana frekvencija srca (uključujući tahikardiju), smanjena agregacija trombocita i snižena razina fibrinogena u plazmi te umjereno produženo parcijalno tromboplastinsko i protrombinsko vrijeme zabilježeni su u literaturi kao mogući učinci nakon peroralne primjene bromelaina.
English: There is limited information on the use of NexoBrid on facial burn wounds.
Croatian: Postoje ograničeni podaci o primjeni NexoBrida na opekline lica.
English: General infections
Croatian: Opće infekcije
English: NexoBrid is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.
Croatian: NexoBrid je indiciran za uklanjanje eshara u odraslih s dubokim termičkim opeklinama djelomične i pune debljine kože.
English: Wound infection
Croatian: infekcija rane
English: Examples of such medicines are: - amiodarone (used to treat certain forms of irregular heartbeat), - amodiaquine and chloroquine (used to treat malaria and some forms of inflammation), - fluvastatin (used to treat high cholesterol), - pioglitazone, rosiglitazone, repaglinide, tolbutamide and glipizide (used to treat diabetes), - paclitaxel and sorafenib (used to treat cancer), - torasemide (used to increase urine flow), - ibuprofen ( used to treat fever, pain and some forms of inflammation), - losartan (used to treat high blood pressure), - celecoxib (used to treat some forms of inflammation), - warfarin (used to reduce blood coagulation), and - phenytoin (used to treat epilepsy).
Croatian: Primjeri takvih lijekova su: - amiodaron (koristi se za liječenje određenih oblika nepravilnog srčanog ritma), - amodiakin i klorokin (koristi se za liječenje malarije i nekih oblika upale), - fluvastatin (koristi se za liječenje visokog kolesterola), - pioglitazon, roziglitazon, repaglinid, tolbutamid i glizipid (koriste se za liječenje šećerne bolesti), - paklitaksel i sorafenib (koristi se za liječenje raka), - torasemid (koristi se za pojačano mokrenje), - ibuprofen (koristi se za liječenje vrućice, boli i nekih oblika upale), - losartan (za liječenje visokog krvnog tlaka), - celekoksib (koristi se za liječenje nekih oblika upale), - varfarin (koristi se za smanjivanje zgrušavanja krvi) i - fenitoin (koristi se za liječenje epilepsije). - pojačati Vašu reakciju na lijekove protiv raka, fluorouracil i vinkristin.
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.
Croatian: Mogu nastati alergijske reakcije na NexoBrid i prouzročiti, na primjer, poteškoće s disanjem, oticanje kože, koprivnjaču, crvenilo kože, niski krvni tlak, povećanu brzinu otkucaja srca i mučninu/povraćanje/grčeve u trbuhu ili kombinaciju takvih učinaka.
English: Removal of NexoBrid
Croatian: Uklanjanje NexoBrida
English: • 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.
Croatian: • Područje opekline se nakon debridmana mora odmah pokriti privremenom ili trajnom zamjenskom kožom ili povojima kako bi se spriječilo sušenje i/ili stvaranje pseudoeshara i/ili infekcije.
English: 60% of the treated wounds area was partial thickness and/or full thickness.
Croatian: Prosječna cjelokupna površina tijela iznosila je 10%, 60% područja liječenih opeklinskih rana zahvaćalo je djelomičnu i/ili punu debljinu kože.
English: • When opening the gel bottle, it must be confirmed that the tamper-evident ring is separating from the bottle's cap.
Croatian: • Prilikom otvaranja boce s gelom, morate provjeriti odvaja li se sigurnosni prsten od zatvarača boce.
English: The gel is clear and colourless.
Croatian: Gel je proziran i bezbojan.
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).
Croatian: Za sprječavanje moguće iritacije oštećene kože nenamjernim kontaktom s NexoBridom i mogućeg krvarenja iz rane, područja akutne rane kao što su laceracije ili esharotomijski rezovi treba zaštititi slojem sterilne masti ili masnim povojem (npr. vazelinskom gazom).
English: NexoBrid powder (vial)
Croatian: Prašak NexoBrid (bočica)
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.
Croatian: Uz rutinsko praćenje kakvo se provodi u bolesnika s opeklinama (npr. vitalni znakovi, status volumena/vode/elektrolita, kompletna krvna slika, razine serumskog albumina i jetrenih enzima), kod bolesnika liječenih NexoBridom treba pratiti pojavu: - povišenja tjelesne temperature.
English: Avoid accidental eye exposure.
Croatian: Izbjegavajte slučajno izlaganje očiju.
English: The use of NexoBrid during pregnancy is not recommended.
Croatian: Ne preporučuje se primjenjivati NexoBrid tijekom trudnoće.
English: Powder 5 g
Croatian: Prašak 5 g
English: • The powder is then transferred into the corresponding gel bottle.
Croatian: • Prenesite prašak u odgovarajuću bocu s gelom.
English: p-value
Croatian: Standardna skrb p-vrijednost
English: Powder 2 g
Croatian: Prašak 2 g
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.
Croatian: • Nakon što se s rane uklone NexoBrid i odumrlo tkivo, stavit će se povoj natopljen antibakterijskom otopinom i ostaviti ga još 2 sata.
English: Pack size of 1 vial of powder and 1 bottle of gel.
Croatian: Veličina pakiranja: 1 bočica praška i 1 boca gela.
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.
Croatian: NexoBrid treba primjenjivati s oprezom u bolesnika s poremećajima koagulacije, niskim brojem trombocita i povećanim rizikom od krvarenja zbog drugih uzroka, npr., peptičkog ulkusa i sepse.