natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
Gel for NexoBrid 2 g
gel za zdravilo NexoBrid 2 g
UNIQUE IDENTIFIER - 2D BARCODE <Not applicable.>
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Navedba smiselno ni potrebna.>
How NexoBrid is used
Kako se uporablja zdravilo NexoBrid
Store upright to keep the gel at the bottom of the bottle and in the original package to protect from light.
Shranjujte pokončno, da ostane gel na dnu steklenice, in v originalni ovojnini za zagotovitev zaščite pred svetlobo.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
This usually requires mixing the NexoBrid powder and the gel for 1 to 2 minutes.
Običajno je treba zdravilo NexoBrid prašek in gel mešati 1 do 2 minuti.
• Within 15 minutes of mixing, NexoBrid must be applied topically to the moistened burn wound, at a thickness of 1.5 to 3 millimetres.
• Po mešanju morate v roku 15 minut zdravilo NexoBrid topikalno nanesti na navlaženo opeklinsko rano z debelino plasti 1,5 do 3 milimetre.
Children and adolescents NexoBrid is not for use in patients younger than 18 years.
Otroci in mladostniki Zdravilo NexoBrid ni primerno za uporabo pri bolnikih, mlajših od 18 let.
Avoid accidental eye exposure.
Preprečite nezgodno izpostavitev očes.
- If you get any side effects, talk to your doctor.
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
65428 Rüsselsheim Germany
65428 Rüsselsheim Nemčija
NexoBrid is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.
Zdravilo NexoBrid je indicirano za odstranitev eshar pri odraslih z globokimi dermalnimi in subdermalnimi termalnimi opeklinami.
*The endpoint can only be evaluated for deep partial-thickness wounds without full-thickness areas because full-thickness burns always require grafting.
*Ta končna točka je bila ocenjena le za globoke dermalne opekline, saj je treba pri subdermalnih opeklinah vedno uporabiti presadek.
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.
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.
Gel for NexoBrid 5 g
gel za zdravilo NexoBrid 5 g
In the NexoBrid group, the event was graded as mild, moderate or severe in 6.7%, 7.8% and 8.9% of patients, respectively.
V skupini z zdravilom NexoBrid so bili dogodki ocenjeni kot blagi pri 6,7 %, zmerni pri 7,8 % in hudi pri 8,9 % bolnikov.
Autografted wounds (ITT)
Rane z avtotransplantatom (ITT)
Gel for NexoBrid powder
Gel za zdravilo NexoBrid prašek
• Other medicines (such as silver sulfadiazine or povidone-iodine) will be removed from the wound area before NexoBrid is applied.
• Druga zdravila (kot sta srebrov sulfadiazin ali povidon-jod) vam bodo pred nanosom zdravila NexoBrid odstranili s predela rane.
• The powder is then transferred into the corresponding gel bottle.
• Prašek nato prenesite v ustrezno stekleničko z gelom.
NexoBrid was well tolerated when applied to intact mini-pig skin but caused severe irritation and pain when applied to damaged (abraded) skin.
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.
Excipients: Acetic acid, ammonium sulphate.
Pomožne snovi: ocetna kislina, amonijev sulfat.
- 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.
- 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.
In the other patients, dose-normalised Cmax ranged from 141-523 ng/ml per gram of NexoBrid.
Pri ostalih bolnikih je bil razpon Cmax, normaliziran na odmerek, od 141-523 ng/ml na gram zdravila NexoBrid.
• You will be given appropriate medicine to prevent and treat pain at least 15 minutes before NexoBrid is applied.
• Vsaj 15 minut pred nanosom zdravila NexoBrid boste prejeli ustrezna zdravila za preprečevanje in zdravljenje bolečine.
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.
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.
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).
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).
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).
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).
• The powder vial must be opened by carefully tearing off the aluminium cap and removing the rubber stopper.
• Vialo s praškom morate previdno odpreti, tako da odtrgate aluminijasto zaporko in odstranite gumijasti zamašek.
- Signs of local or systemic allergic reactions.
driska), - znake lokalnih ali sistemskih alergijskih reakcij, - možnega učinka na hemostazo (glejte zgoraj).
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.
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.
Allergic reactions to bromelain include anaphylactic reactions and other immediate-type reactions with manifestations such as bronchospasm, angiooedema, urticaria, and mucosal and gastrointestinal reactions.
Alergijske reakcije na bromelain vključno anafilaktične reakcije in druge takojšnje reakcije s pojavnimi oblikami, kot so bronhospazem, angioedem, urtikarija in reakcije sluznice in prebavil.
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.
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.
• 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.
• Po odstranitvi zdravila NexoBrid in mrtvega tkiva z rane vam bodo na rano za 2 uri položili oblogo, namočeno z antibakterijsko raztopino.
No studies were performed to assess the effects of NexoBrid on fertility.
Študij za ocenitev učinka zdravila NexoBrid niso opravili.
1 vial of 2 g powder 1 bottle of 20 g of gel
prašek in gel za gel 1 viala z 2 g praška 1 steklenica z 20 g gela
Before it is applied to a burn wound, NexoBrid powder is mixed into a gel.
Preden se zdravilo NexoBrid prašek nanese na opeklinsko rano, se morate prašek zmešati v gel.
• 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
• 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
What NexoBrid is
Kaj je zdravilo NexoBrid
1 vial of 5 g powder 1 bottle of 50 g of gel
prašek in gel za gel 1 viala s 5 g praška 1 steklenica s 50 g gela
- you have a heart disease; - you have a lung disease; - your lung has been, or may have been damaged by inhalation of smoke;
- 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:
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.
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.
Mixed wounds (with partial and full-thickness area) autografted NexoBrid (Number of wounds)
Mešane rane (z dermalnimi in subdermalnimi predeli) z avtotransplantatom Zdravilo NexoBrid (število ran)
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).
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).
This should be considered when mixing NexoBrid powder with the gel.
To je treba upoštevati pri mešanju zdravila NexoBrid prašek z gelom.
Rare (1/10,000 to <1/1,000)
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)
NexoBrid is for use by specialists in burn clinics only.
Zdravilo NexoBrid lahko uporabljajo samo specialisti z izkušnjami pri zdravljenju opeklin.
A total wound area of not more than 15% TBSA can be treated with NexoBrid (see also section 4.4, Coagulopathy).
V enem postopku se lahko zdravilo NexoBrid nanese na največ 15 % CPT (glejte tudi poglavje 4.4, Koagulopatija).
What NexoBrid is used for
Za kaj se uporablja zdravilo NexoBrid
Excipients for the powder: Acetic acid, ammonium sulphate.
Pomožne snovi za prašek: ocetna kislina, amonijev sulfat.
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.
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.
There is no experience of the use of NexoBrid on: - perineal and genital burns.
Opekline, pri katerih je izkušenj malo oz. izkušenj ni Z uporabo zdravila NexoBrid ni izkušenj pri: - perinealnih in genitalnih opeklinah, - električnih opeklinah.
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.
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.
• Powder and gel must be mixed thoroughly until a uniform, slightly tan to slightly brown mixture is obtained.
• Prašek in gel morate dobro premešati, da dobite enakomerno, rahlo svetlorjavo do rjavkasto mešanico.
There is very limited information on the use of NexoBrid on areas where eschar remained after the first application.
Informacij o uporabi zdravila NexoBrid na predelih, kjer so eshare ostale po prvem nanosu, je malo.
In the 4 patients with indications of higher absorption, dose-normalised Cmax ranged from 788-900 ng/ml per gram of NexoBrid.
Pri 4 bolnikih z znaki večje absorpcije je bil Cmax, normaliziran na odmerek, v razponu 788-900 ng/ml na gram zdravila NexoBrid.
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.
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.
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.
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.
• Wounds with areas of full-thickness and deep burn should be autografted as soon as possible after NexoBrid debridement.
• Na rane s predeli globokih in subdermalnih opeklin je treba presaditi avtotransplantate takoj, ko je mogoče po čiščenju z zdravilom NexoBrid.
Posology 5 g NexoBrid powder in 50 g gel is applied to a burn wound area of 250 cm
Zdravilo NexoBrid 5 g prašek, vmešan 50 g gel se nanese na predel opeklinske rane površine 250 cm
In case of eye exposure, exposed eyes must be irrigated with copious amounts of water for at least 15 minutes.
Če pride do izpostavitve, morate izpostavljene oči vsaj 15 minut izpirati z veliko vode.
There is no information on the use of NexoBrid in patients with renal impairment.
Ni podatkov o uporabi zdravila NexoBrid pri bolnikih z okvaro ledvic.
Gentle pressing of the occlusive dressing at the area of contact with the adhesive barrier will ensure adherence between the occlusive film and the barrier and achieve complete containment of NexoBrid on the treatment area.
Z nežnim pritiskom na okluzivno oblogo na predelu stika z adhezivno pregrado je mogoče zagotoviti prileganje okluzivnega filma in pregrade in doseči, da ostane vso zdravilo NexoBrid znotraj zdravljenega predela.
Accidental eye exposure must be avoided.
Nezgodno izpostavitev očes morate preprečiti.
• Pain management must be used as commonly practiced for an extensive dressing change; it should be initiated at least 15 minutes prior to NexoBrid application.
• Pri obsežni menjavi oblog morate uporabiti običajen način obvladovanja bolečine, ki ga je treba bolniku dati vsaj 15 minut pred nanosom zdravila NexoBrid.
In the patients with indications of higher absorption, dose-normalised (per gram of NexoBrid) AUClast ranged from 4500-9820 ngh/ml per gram of NexoBrid.
Pri bolnikih z nakazano višjo absorpcijo je bil AUClast, normaliziran na odmerek (na gram zdravila NexoBrid), v razponu 4.500-9.820 ngh/ml na gram zdravila NexoBrid.
Removal of topically applied antibacterial medicinal products before NexoBrid application
Odstranite vseh topikalno nanesenih antibakterijskih zdravil pred nanosom zdravila NexoBrid
Concentrate of proteolytic enzymes enriched in bromelain: 0.09 g/g (or 5 g/55 g gel) after mixing.
Koncentrat proteolitičnih encimov, obogatenih z bromelainom: 0,09 g/g (ali 5 g/55 g gela) po mešanju.
• NexoBrid will be applied to a wound area that is clean, blister free, and moist.
• Zdravilo NexoBrid vam bo zdravnik nanesel na predel rane, ki je čist, brez mehurjev in vlažen.
NexoBrid is provided as a powder and gel for gel (powder in a vial (5 g) and gel in a bottle (50 g)), pack size of 1 (a pack contains one vial of powder and one bottle of gel.
Zdravilo NexoBrid je na voljo v obliki praška in gela za gel (prašek v viali (5 g) in gel v steklenički (50 g)), velikost pakiranja 1 (pakiranje vsebuje eno vialo s praškom in eno stekleničko z gelom).
e.g. urinary tract infections, viral infections) were reported more frequently in the NexoBrid group (0.147 events per patient) than in the group treated according to SOC (0.079 events per patient).
V kliničnih študijah 2. faze in 3. faze so o splošnih okužbah (nepovezano z rano, npr. okužbe sečil, virusne okužbe) pogosteje poročali v skupini, zdravljeni z zdravilom NexoBrid (0,147 dogodka na bolnika), kot v skupini, zdravljeni s standardno nego (0,079 dogodka na bolnika).
NexoBrid application
dermalna uporaba
SOC (Number of wounds)
Standardna nega (število ran)
• The NexoBrid powder vial must be opened by carefully tearing off the aluminium cap and removing the rubber stopper.
• Vialo s praškom zdravila NexoBrid morate previdno odpreti, tako da odtrgate aluminijasto zaporko in odstranite gumijasti zamašek.
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.
Kot o možnih neželenih učinkih po peroralnem dajanju bromelaina so v literaturi poročali o hitrejšem bitju srca (vključno s tahikardijo), zmanjšani agregaciji trombocitov in ravni fibrinogenov v plazmi ter zmernem povečanju delnega tromboplastinskega in protrombinskega časa.
% of wounds requiring surgery % of wound area excised or dermabraded
Število ran % ran, ki jih je treba operirati % predela ran z ekscizijo ali dermabrazijo
Concentrate of proteolytic enzymes enriched in bromelain: 0.09 g/g (or 2 g/22 g gel) after mixing.
Koncentrat proteolitičnih encimov, obogatenih z bromelainom: 0,09 g (ali 2 g/22 g gela) po mešanju.
5 g powder in a vial (glass type II) sealed with a rubber (bromobutyl), stopper and covered with a cap (aluminium), and 50 g gel in a bottle (borosilicate, glass type I), sealed with a rubber stopper and covered with a screw cap (tamper-proof polypropylene).
5 g praška v viali (steklo tipa II), zamašeni z gumijastim (bromobutilnim) zamaškom, prekriti z zaporko (aluminij), in 50 g gela v steklenički (borosilikat iz stekla tipa I), zamašeni z gumijastim zamaškom in prekriti z varnostno navojno zaporko (polipropilen, ki se poškoduje ob odpiranju).
2 g powder in a vial (glass type II) sealed with a rubber (bromobutyl), stopper and covered with a cap (aluminium), and 20 g gel in a bottle (borosilicate, glass type I), sealed with a rubber stopper and covered with a screw cap (tamper-proof polypropylene).
2 g praška v viali (steklo tipa II), zamašeni z gumijastim (bromobutilnim) zamaškom, prekriti z zaporko (aluminij), in 20 g gela v steklenički (borosilikat iz stekla tipa I), zamašeni z gumijastim zamaškom in prekriti z varnostno navojno zaporko (polipropilen, ki se poškoduje ob odpiranju).
Mixed wounds (with partial and full-thickness area) requiring excision/dermabrasion (surgery) NexoBrid
Mešane rane (z dermalnimi in subdermalnimi predeli), ki potrebujejo ekscizijo/dermabrazijo (operativni poseg)
NexoBrid 2 g powder and gel for gel
NexoBrid 2 g prašek in gel za gel
There is no information on the use of NexoBrid in patients with hepatic impairment.
Ni podatkov o uporabi zdravila NexoBrid pri bolnikih z okvaro jeter.
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).
- torazemid (uporablja se za povečanje izločanja urina), - ibuprofen (uporablja se za zdravljenje povišane telesne temperature, bolečine in nekaterih oblik vnetja), - losartan (uporablja se za zdravljenje visokega krvnega tlaka), - celekoksib (uporablja se za zdravljenje nekaterih vrst vnetja), - varfarin (uporablja se za zmanjšanje strjevanja krvi) in - fenitoin (uporablja se za zdravljenje epilepsije).
In the other patients, dose-normalised AUClast ranged from 887-3930 ngh/ml per gram of NexoBrid.
Pri ostalih bolnikih je bil razpon AUClast, normaliziran na odmerek, od 8873.930 ng/ml na gram zdravila NexoBrid.
• Appropriate preventive analgesia medicinal products must be administered.
• Bolniku morate dati ustrezen analgetik.
Carbomer 980 disodium phosphate anhydrous Sodium hydroxide Water for injections
Gel karbomer 980 brezvodni natrijev hidrogenfosfat natrijev hidroksid voda za injekcije
Posology 2 g NexoBrid powder in 20 g gel is applied to a burn wound area of 100 cm
Zdravilo NexoBrid 2 g prašek, vmešan v 20 g gel se nanese na predel opeklinske rane površine 100 cm
NexoBrid should be applied to a clean, keratin-free (blisters removed), and moist wound area.
Zdravilo NexoBrid se nanese na čist in vlažen predel ranjene kože, na katerem ni keratina (mehurji so odstranjeni).
All topically applied antibacterial medicinal products must be removed before applying NexoBrid.
Pred nanosom zdravila NexoBrid je treba odstraniti vsa topikalno nanesena antibakterijska zdravila.