FrancophonIA/ELRC3.0 huggingface dataset:
English: See also section 4.2 and 4.8.
Maltese: Ara wkoll sezzjoni 4.2 u 4.8.
English: Coagulopathy
Maltese: Koagulopatija
English: NexoBrid, when absorbed, is an inhibitor of cytochrome P 450 2C8 (CYP2C8) and P450 2C9 (CYP2C9).
Maltese: NexoBrid, meta assorbit, hu inibitur ta' ċitokrom P 450 2C8 (CYP2C8) u P450 2C9 (CYP2C9).
English: SOC (Number of wounds)
Maltese: SOC (Numru ta' feriti)
English: Rare (1/10,000 to <1/1,000)
Maltese: Rari (1/10,000 sa <1/1,000)
English: Autografted wounds (ITT)
Maltese: Feriti awtotrapjantati (ITT)
English: See section 6.6 for instructions on NexoBrid gel preparation.
Maltese: Ara sezzjoni 6.6 għal istruzzjonijiet dwar il-preparazzjoni tal-ġell NexoBrid.
English: In 4 patients, having received a dose of 5, 9, 12 and 17 g, respectively, there were indications of markedly higher systemic absorption.
Maltese: F'4 pazjenti, wara li rċivew doża ta' 5, 9, 12 u 17 g, rispettivament, kien hemm indikazzjonijiet ta' assorbiment sistemiku li kien ogħla b'mod notevoli.
English: Bromelain may enhance the actions of fluorouracil and vincristine.
Maltese: Bromelain jista' jkabbar l-azzjonijiet ta' fluorouracil u vincristine.
English: MediWound Germany GmbH 65428 Rüsselsheim Germany
Maltese: MediWound Germany GmbH 65428 Rüsselsheim
English: Experience with NexoBrid in elderly patients (>65 years) is limited.
Maltese: Esperjenza b'NexoBrid f'pazjenti anzjani (>65 sena) hi limitata.
English: Date of first authorisation: 18.12.2012 Date of latest renewal: 10.11.2017
Maltese: Diċembru. 2012 Data tal-aħħar tiġdid: 10 Novembru. 2017
English: NexoBrid powder Ammonium sulphate Acetic acid
Maltese: NexoBrid trab Ammonium sulphate Acetic acid
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.
Maltese: L-AUC minn ħin żero sa 48 siegħa wara l-għoti (AUClast) kien ta' 43,400 ± 46,100 ngh/ml (medja ± SD) għall-grupp ta' 15-il pazjent, b'medda ta' 4560-167,000 ngh/ml.
English: Days (mean ± SD) (Number of wounds)
Maltese: Jiem (medja ± SD) (Numru ta' feriti)
English: Excipients: Acetic acid, ammonium sulphate.
Maltese: Eċċipjenti: Acetic acid, ammonium sulphate.
English: There is limited pharmacokinetic data in patients with TBSA of more than 15%.
Maltese: Hemm dejta farmakokinetika limitata f'pazjenti b'TBSA ta' iktar minn 15%.
English: D-48155 Münster Germany
Maltese: D-48155 Münster Il-Ġermanja
English: Local pain*
Maltese: Uġigħ lokali*
English: According to a literature report, in plasma, approximately 50% of bromelain binds to the human plasma antiproteinases α2-macroglobulin and α1-antichymotrypsin.
Maltese: Skont rapport fil-letteratura medika, fil-plażma, madwar 50% ta' bromelain jintrabat malantiprontineases α2-macroglobulin u α1-antichymotrypsin fil-plażma.
English: NexoBrid showed no genotoxic activity when investigated in the standard set of in vitro and in vivo studies.
Maltese: NexoBrid ma wera l-ebda attività ġenotossika meta ġie investigat fis-sett standard ta' studji in vitro u in vivo.
English: Pyrexia/hyperthermia*
Maltese: Deni/ipertermija*
English: NexoBrid (2 g/100 cm 2, corresponding to 0.02 g/cm 2) was used as described in section 4.2.
Maltese: NexoBrid (2 g/100 ċm2, li jikkorrispondu għal 0.02 g/ċm2) intuża kif deskritt f'sezzjoni 4.2.
English: - Signs of local and systemic inflammatory and infectious processes.
Maltese: - Sinjali ta' proċessi infjammatorji lokali u sistemiċi u proċessi infettivi.
English: NexoBrid serum concentrations were determined using a modified sandwich electrochemiluminescence (ECL) immunoassay.
Maltese: Il-konċentrazzjonijiet ta' NexoBrid fis-serum ġew stabbiliti bl-użu ta' immunoassaġġ modifikat ta' sandwich electrochemiluminescence (ECL).
English: The age range in the SOC group was 5.1 to 55.7 years.
Maltese: Il-medda ta' età fil-grupp SOC minn 5.1 sa 55.7 sena.
English: Size: % mean TBSA Depth: Superficial (%TBSA) DPT (% TBSA) FT (% TBSA) Incidence of autograft
Maltese: Superfiċjali (%TBSA) DPT (% TBSA)
English: NexoBrid powder (vial)
Maltese: NexoBrid trab (kunjett)
English: Pyrexia/hyperthermia
Maltese: Deni/ipertermija
English: 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).
Maltese: Dan għandu jiġi kkunsidrat jekk NexoBrid jintuża f'pazjenti li jkunu qed jirċievu substrati ta' CYP2C8 (li jinkludu amiodarone, amodiaquine, chloroquine, fluvastatin, paclitaxel, pioglitazone, repaglinide, rosiglitazone, sorafenib u torasemide) u substrati CYP2C9 (li jinkludu ibuprofen, tolbutamide, glipizide, losartan, celecoxib, warfarin, u phenytoin).
English: After applying NexoBrid
Maltese: Applikazzjoni ta' NexoBrid
English: Bromelain may increase drowsiness caused by some medicinal products (e.g., benzodiazepines, barbiturates, narcotics and antidepressants).
Maltese: Bromelain jista' jżid in-ngħas ikkawżat minn xi prodotti mediċinali (eż., benzodiazepines, barbiturates, narkotiċi u antidipressanti).
English: Concentrate of proteolytic enzymes enriched in bromelain
Maltese: Konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain
English: See also section 4.4.
Maltese: Ara wkoll sezzjoni 4.4.
English: Gel 20 g
Maltese: Ġell 20 g
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Maltese: <barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: • Sterile isotonic sodium chloride 9 mg/ml (0.9%) solution must be sprinkled on the burn wound.
Maltese: • Soluzzjoni sterilizzata ta' isotonic sodium chloride 9 mg/ml (0.9%) trid titferrex fuq il-ferita kkawżata minn ħruq.
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable.>
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: Uncommon (1/1,000 to <1/100)
Maltese: Mhux komuni (1/1,000 sa <1/100)
English: Deep Partial Thickness wounds
Maltese: Feriti bi Ħxuna Parzjali Profonda
English: Topically applied antibacterial medicinal products (e.g. silver sulfadiazine or povidone iodine) may decrease the efficacy of NexoBrid (see section 4.4).
Maltese: Prodotti mediċinali antibatteriċi applikati b'mod topiku (eż. silver sulfadiazine jew povidone iodine) jistgħu jnaqqsu l-effikaċja ta' NexoBrid (ara sezzjoni 4.4).
English: • The limitation of the total area than can be treated to 15% TBSA
Maltese: • Il-limitazzjoni tal-erja totali sa 15% TBSA li tista' tiġi kkurata
English: Cmax was 6020 ± 5020 ng/ml (mean ± SD) for the group of 15 patients, with a range of 888 to 15,700 ng/ml.
Maltese: Is-Cmax kienet 6020 ± 5020 ng/ml (medja ± SD) għall-grupp ta' 15-il pazjent, b'medda ta' 888 sa 15,700 ng/ml. Fl-4 pazjenti b'indikazzjonijiet ta' assorbiment ogħla, is-Cmax normalizzata għad-doża varjat minn 788-900 ng/ml għal kull gramma ta' NexoBrid.
English: Powder 2 g
Maltese: Trab 2 g
English: Risk Management Plan (RMP)
Maltese: Pjan tal-immaniġġar tar-riskju (RMP)
English: During clinical development, a total of 362 patients were treated with the concentrate of proteolytic enzymes enriched in bromelain.
Maltese: Matul l-iżvilupp kliniku, total ta' 362 pazjent ġew ikkurati bil-konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain.
English: Gel 50 g
Maltese: Ġell 50 g
English: Powder 5 g
Maltese: Trab 5 g
English: Hypersensitivity reactions, skin exposure
Maltese: Reazzjonijiet ta' sensittività eċċessiva, espożizzjoni tal-ġilda
English: • The wound assessment and the warning against any repeat treatment
Maltese: • L-evalwazzjoni tal-ferita u t-twissija kontra kwalunkwe kura ripetuta
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.
Maltese: Fil-grupp ta' NexoBrid, l-avveniment ġie kklassifikat bħala ħafif, moderat jew sever f'6.7%, 7.8%, u 8.9% tal-pazjenti, rispettivament.
English: Carbomer 980 disodium phosphate anhydrous Sodium hydroxide Water for injections
Maltese: Carbomer 980 disodium phosphate anhydrous Sodium hydroxide Ilma għall-injezzjonijiet
English: 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.
Maltese: Il-half-life terminali (stabbilita bl-użu ta' dejta minn 16 sa 48 siegħa wara d-doża għal 12-il pazjent) kienet ta' 11.7 ± 3.5 sigħat (medja ± SD), b'medda minn 8.5 sa 19.9 sigħat.
English: Gel for NexoBrid 5 g
Maltese: Ġell għal NexoBrid 5 g
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).
Maltese: Kura bil-konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain ippreparati fi proporzjon trab:ġell ta' 1:5 (0.16 g f'kull 1 g ta' ġell imħallat) f'pazjenti b'feriti profondi parzjali tal-ġilda u/jew tal-ħxuna sħiħa tal-ġilda kkawżati minn ħruq fil-qafas ta' studju kliniku, ma rriżultatx f'riżultati tas-sigurtà li kienu differenti b'mod sinifikanti meta mqabbla mal-kura b'konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain ippreparati fi proporzjon trab:ġell ta' 1:10 (0.09 g f'kull 1 g ta' ġell imħallat).
English: The age range in the group treated with NexoBrid was 4.4 to 55.7 years.
Maltese: Il-medda ta' età fil-grupp ikkurat b'NexoBrid kienet minn 4.4 sa 55.7 sena.
English: Gel for NexoBrid 2 g
Maltese: Ġell għal NexoBrid 2 g
English: NexoBrid may: - increase the effects of certain medicines that are inactivated by a liver enzyme called CYP2C8 and CYP2C9.
Maltese: NexoBrid jista': - iżid l-effetti ta' ċerti mediċini li jiġu ddiżattivati minn enzima tal-fwied imsejħa CYP2C8 u CYP2C9.
English: 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.
Maltese: Fil-pazjenti b'indikazzjonijiet ta' assorbiment ogħla, l-AUClast normalizzata għad-doża (għal kull gramma ta' NexoBrid) varjat minn 4,500-9,820 ngh/ml għal kull gramma ta' NexoBrid.
English: Excipients for the powder: Acetic acid, ammonium sulphate.
Maltese: Eċċipjenti għat-trab: Acetic acid, ammonium sulphate.
English: The proteolytic enzymes are a mixture of enzymes from the stem of Ananas comosus (pineapple plant).
Maltese: L-enzimi proteolitiċi huma taħlita ta' enzimi estratti mill-istemma ta' Ananas comosus (pjanta talananas).
English: Tmax for 10 of the 15 patients was 2 hours and in 5 patients Tmax was 4 hours.
Maltese: It-Tmax għal 10 mill-15-il pazjent kien ta' sagħtejn u f'5 pazjenti, it-Tmax kien ta' 4 sigħat.
English: 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.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għall-ananas jew papain, (ara wkoll sezzjoni 4.4), jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 30.0%, 5.6% and 1.1% of patients, respectively.
Maltese: Fil-grupp ta' NexoBrid, lavveniment ġie kklassifikat bħala ħafif, moderat jew sever fi 30.0%, 5.6%, u 1.1% tal-pazjenti, rispettivament.
English: - chemical burn wounds.
Maltese: - feriti kimiċi kkawżati minn ħruq.
English: In the other patients, dose-normalised AUClast ranged from 887-3930 ngh/ml per gram of NexoBrid.
Maltese: Fil-pazjenti l-oħra, lAUClast normalizzata għad-doża varjat minn 887-3930 ngh/ml għal kull gramma ta' NexoBrid.
English: In studies without antibacterial soaking, pyrexia or hyperthermia was reported in 35.6% of NexoBridtreated patients compared with 18.6% in control patients.
Maltese: Fi studji mingħajr tgħaddis antibatteriku, deni jew ipertermija ġew irrappurtati f'35.6% tal-pazjenti kkurati b'NexoBrid meta mqabbla ma' 18.6% fil-pazjenti tal-kontroll.
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.
Maltese: Sensittività inkroċjata bejn bromelain u papain kif ukoll proteini tal-latex (magħrufa bħala sindrome ta' latex-frott), velenu tan-naħal, u polline tas-siġra taż-żebbuġ, ġiet irrappurtata fil-letteratura.
English: NexoBrid 2 g powder
Maltese: NexoBrid 2 g trab
English: Concentrate of proteolytic enzymes enriched in bromelain: 0.09 g/g (or 5 g/55 g gel) after mixing.
Maltese: Konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain: 0.09 g/g (jew 5 g/55 g ta' gel) wara li jitħallat.
English: From these data it is expected that the overall safety profile in children 4 years of age and older and in adolescents is similar to the profile in adults.
Maltese: Minn din id-dejta hu mistenni li l-profil tas-sigurtà globali fit-tfal li għandhom 4 snin u aktar u fl-adolexxenti hu simili għall-profil f'persuni adulti.
English: • The risk of increased mortality in patients with cardiopulmonary diseases
Maltese: • Ir-riskju ta' żieda fil-mortalità f'pazjenti b'mard kardjopulmonari
English: However, maternal exposure levels were considerably lower than those maximally reported in clinical setting (10-500 times lower than human AUC, 3-50 times lower than the human Cmax).
Maltese: Madankollu, livelli ta' espożizzjoni materna kienu iktar baxxi b'mod konsiderevoli minn dawk massimi rrappurtati fi sfond kliniku (10-500 darba iktar baxxi mill-AUC umana, 3-50 darba iktar baxxi mis-Cmax umana).
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: NexoBrid should not be applied to more than 15% Total Body Surface Area (TBSA) (see also section 4.4, Coagulopathy).
Maltese: NexoBrid m'għandux jiġi applikat fuq iktar minn 15% tal-Erja Totali tas-Superfiċje tal-Ġisem (TBSA) (ara wkoll sezzjoni 4.4, Koagulopatija).
English: In the other patients, dose-normalised Cmax ranged from 141-523 ng/ml per gram of NexoBrid.
Maltese: Fil-pazjenti l-oħra, is-Cmax normalizzata għad-doża varjat minn 141-523 ng/ml għal kull gramma ta' NexoBrid.
English: Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 4.8 u 5.1 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: - Potential effects on haemostasis (see above).
Maltese: - Effetti potenzjali fuq l-emostasi (ara hawn fuq).
English: Gel
Maltese: JIS
English: Full Thickness wounds
Maltese: Feriti mħallta awtotrapjantati
English: NexoBrid 5 g powder
Maltese: NexoBrid 5 g trab
English: Due to safety considerations (see also section 4.4, Coagulopathy) NexoBrid should not be applied to more than 15%Total Body Surface Area (TBSA).
Maltese: Minħabba konsiderazzjonijiet tas-sigurtà (ara wkoll sezzjoni 4.4, Koagulopatija) NexoBrid m'għandux jiġi applikat fuq iktar minn 15% ta' Erja Totali tas-Superfiċje tal-Ġisem (TBSA).
English: Concentrate of proteolytic enzymes enriched in bromelain is systemically absorbed from burn wound areas (see section 5.2).
Maltese: Konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain jiġi assorbit b'mod sistemiku minn żoni b'feriti kkawżati minn ħruq (ara sezzjoni 5.2).
English: 1 vial of 2 g powder 1 bottle of 20 g of gel
Maltese: 1 kunjett ta' 2 g ta' trab 1 flixkun ta' 20 g ta' ġell
English: Removal of topically applied antibacterial medicinal products before NexoBrid application
Maltese: It-tneħħija ta' prodotti mediċinali antibatterjali applikati b'mod topiku qabel l-applikazzjoni ta' NexoBrid
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).
Maltese: Dawn l-avvenimenti kienu jinkludu: il-ferita ssir aktar fonda jew tinxef (dekompożizzjoni) f'5 pazjenti (2.4%) b'NexoBrid u 0 b'SOC kif ukoll trapjant li ma jirnexxix (parzjali) f'6 pazjenti (2.9%) b'NexoBrid u 2 (1.6%) b'SOC (ara sezzjoni 4.4).
English: This usually requires mixing the powder and the gel for 1 to 2 minutes.
Maltese: Dan normalment jeħtieġ li tħallat NexoBrid trab u lġell għal minn 1 sa 2 minuti.
English: 1 vial of 5 g powder 1 bottle of 50 g of gel
Maltese: 1 kunjett ta' 5 g ta' trab 1 flixkun ta' 50 g ta' ġell
English: - Signs of local or systemic allergic reactions.
Maltese: - Sinjali ta' reazzjonijiet allerġiċi lokali jew sistemiċi.
English: Immune system disorders Not known:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna:
English: • The NexoBrid powder and gel are sterile.
Maltese: • NexoBrid trab u ġell huma sterilizzati.
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 0.9%, 0.9%, and 1.8% of patients, respectively.
Maltese: Fil-grupp ta' NexoBrid, l-avveniment ġie kklassifikat bħala ħafif, moderat jew sever f'0.9%, 0.9%, u 1.8% tal-pazjenti, rispettivament.
English: A total wound area of not more than 15% TBSA can be treated with NexoBrid (see also section 4.4, Coagulopathy).
Maltese: Żona totali ta' ferita ta' mhux iktar minn 15% TBSA tista' tiġi kkurata b'NexoBrid (ara wkoll sezzjoni 4.4, Koagulopatija).
English: • Healthcare Professional information pack
Maltese: • Pakkett ta' informazzjoni għall-professjonisti fil-qasam mediku
English: • 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
Maltese: • Ir-riskju ta' reazzjoni allerġika u ta' reattività inkroċjata u l-kontraindikazzjoni f'pazjenti li huma allerġiċi għall-ananas u l-papain jew għal applikazzjoni tal-prodott fil-passat
English: Concentrate of proteolytic enzymes enriched in bromelain: 0.09 g/g (or 2 g/22 g gel) after mixing.
Maltese: Konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain: 0.09 g/g (jew 2 g/22 g ta' ġell) wara li jitħallat.
English: 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.
Maltese: Il-grad ta' assorbiment sistemiku minn ferita kkawżata minn ħruq, Cmax, Tmax, AUC, u t½ ta' bromelain minn NexoBrid ġie investigat f'16-il pazjent li kellhom feriti termali kkawżati minn ħruq, ta' ħxuna parzjali tal-ġilda (feriti minn medji sa fondi fil-ġilda).
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.
Maltese: NexoBrid fih taħlita ta' enzimi, imsejħa “konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain”, li huwa prodott minn estratti mill-istemma tal-pjanta tal-ananas.
English: • The wound must be wiped thoroughly first with a large sterile dry gauze or napkin, followed by a sterile gauze or napkin that has been soaked with sterile isotonic sodium chloride 9 mg/ml (0.9%) solution.
Maltese: • Il-ferita trid tintmesaħ bir-reqqa l-ewwel, b'garża kbira xotta u sterilizzata jew napkin, segwita minn ġarża sterilizzata jew napkin li tkun ġiet imxarrba b'soluzzjoni isotonika ta' sodium chloride 9 mg/ml (0.9%).
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.
Maltese: L-effikaċja ta' NexoBrid fil-bnedmin ġiet evalwata, meta mqabbla ma' standard ta' kura, fi studju ta' fażi 3 li fih il-parteċipanti ntgħażlu b'mod każwali, multiċentriku, multinazzjonali, open-label, u konfermatorju, li sar fuq pazjenti rikoverati l-isptar li kellhom feriti termali profondi parzjali tal-ġilda u/jew tal-ħxuna sħiħa tal-ġilda kkawżati minn ħruq ta' 5 sa 30% tal-Erja Totali tas-Superfiċje talĠisem (TBSA), iżda b'feriti totali kkawżati minn ħruq ta' mhux iktar minn 30% tat-TBSA.
English: Skin and subcutaneous tissue disorders/ Common:
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda/ Komuni:
English: The range of total dose applied was 5 to 30 g concentrate of proteolytic enzymes enriched in bromelain from NexoBrid.
Maltese: Il-medda tad-doża totali applikati kienet minn 5 sa 30 g ta' konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain minn NexoBrid.
English: Posology 5 g NexoBrid powder in 50 g gel is applied to a burn wound area of 250 cm
Maltese: Pożoloġija 5 g NexoBrid trab f'50 g ta' ġell jiġi applikat fuq żona ta' ferita kkaġunata minn ħruq ta' 250 cm
English: Gel for NexoBrid powder
Maltese: Ġell għal NexoBrid trab
English: Excipients: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, water for injections.
Maltese: Eċċipjenti: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, ilma għallinjezzjonijiet.
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 9.1%, 9.1%, and 0% of patients, respectively.
Maltese: Filgrupp ta' NexoBrid, l-avveniment ġie kklassifikat bħala ħafif, moderat jew sever f'9.1%, 9.1%, u 0% tal-pazjenti, rispettivament.
English: The available data are limited and NexoBrid should not be used in patients younger than 18 years.
Maltese: Id-dejta disponibbli hi limitata u NexoBrid m'għandux jintuża f'pazjenti li għandhom inqas minn 18-il sena.
English: 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.
Maltese: Paragun ma' standard ta' kura (protokoll MW2010-03-02), ibbażat fuq protokoll approvat mis-CHMP.
English: The major constituent is stem bromelain.
Maltese: Il-kostitwent maġġuri hu stem bromelain.
English: Wound Type
Maltese: U LUŻU
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.
Maltese: • Fi żmien 15-il minuta minn x'ħin jitħallat, NexoBrid irid jiġi applikat b'mod topiku fuq il-ferita mxarrba kkawżata minn ħruq, bi ħxuna ta' 1.5 sa 3 millimetri.
English: • Appropriate preventive analgesia medicinal products must be administered.
Maltese: • Prodotti mediċinali adattati b'analġesija preventiva jridu jiġu applikati.
English: Patients should be monitored for possible signs of coagulation abnormalities.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali possibbli ta' anormalitajiet fil-koagulazzjoni.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/803/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/803/002
English: Cutaneous use.
Maltese: U KWANTITATTIVA
English: The safety and efficacy of NexoBrid in children and adolescents younger than 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' NexoBrid fit-tfal u adolexxenti li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
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.
Maltese: Injezzjonijiet ġol-vini ripetuti ta' dożi sa 12 mg/kg kull tielet jum fil-mini-pig kienu ttollerati tajjeb għall-ewwel tliet injezzjonijiet, iżda sinjali kliniċi severi ta' tossiċità (eż. emorraġiji f'diversi organi) ġew osservati wara t-tliet injezzjonijiet li kien fadal.