FrancophonIA/ELRC3.0 huggingface dataset:
English: A Cmax of 40µg/ml may be possible in humans administered NexoBrid under licensed conditions, when it is considered that PK has only been evaluated in patients with largely superficial burns, receiving half the maximum dose.
Maltese: Cmax ta' 40 µg/ml jista' jkun possibbli f'nies li jingħataw NexoBrid taħt il-kundizzjonijiet liċenzjati, meta jiġi kkunsidrat li l-PK ġiet evalwata biss f'pazjenti li fil-biċċa l-kbira tagħhom kellhom ħruq superfiċjali, li kienu qed jirċievu nofs id-doża massima.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Fi żmien 60 jum minn meta jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskju);
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).
Maltese: - paclitaxel u sorafenib (jintużaw għall-kura tal-kanċer), - torasemide (jintuża biex iżid il-fluss tal-awrina), - ibuprofen (jintuża għal kura ta' deni, uġigħ u xi forom ta' infjammazzjoni), - losartan (jintuża għal kura ta' pressjoni tad-demm għolja), - celecoxib (jintuża għal kura ta' xi forom ta' infjammazzjoni), - warfarin (jintuża biex inaqqas il-koagulazzjoni tad-demm), u - phenytoin (jintuża għal kura tal-epilessija). - jintensifika r-reazzjoni tiegħek għall-mediċini kontra l-kanċer fluorouracil u vincristine. - jikkawża tnaqqis mhux mixtieq fil-pressjoni tad-demm meta tiġi kkurat b'mediċini msejħa inibituri ACE, li jintuża għall-kura ta' pressjoni tad-demm għolja u kundizzjonijiet oħrajn. - iżid in-ngħas meta jintuża fl-istess ħin ma' mediċini li jistgħu jikkawżaw in-ngħas.
English: 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).
Maltese: 5 g trab f'kunjett (ħġieġ ta' tip II) issiġillat b'tapp tal-lastku (bromobutyl), tapp u miksi b'għatu (aluminju), u 50 g ġell fi flixkun (borosilicate, ħġieġ ta' tip I), issiġillat b'tapp tal-lastku u miksi b'għatu bil-kamin (polypropylene li ma jistax isir tbagħbis fih).
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.
Maltese: Fi studji fejn il-kors b'NexoBrid kien jinkludi analġesija preventiva rakkomandata kif ippratikata regolarment għal tibdil estensiv ta' faxex f'pazjenti b'feriti kkawżati minn ħruq (ara sezzjoni 4.2) uġigħ lokali ġie rrappurtat fi 3.6% ta' pazjenti kkurati b'NexoBrid u f'4.0% tal-pazjenti tal-kontroll ikkurati skont standard ta' kura.
English: The other ingredients are: for the powder: ammonium sulphate and acetic acid and for the gel carbomer 980, disodium phosphate anhydrous, sodium hydroxide, and water for injections.
Maltese: Is-sustanzi l-oħra huma: għat-trab: ammonium sulphate u acetic acid u għal ġell carbomer 980, disodium phosphate anhydrous, sodium hydroxide, u ilma għal-injezzjonijiet.
English: % of wounds requiring surgery
Maltese: % taż-żona ta' feriti awtotrapjantati
English: • 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.
Maltese: • Inti se tingħata mediċina adattata biex tipprevjeni u tikkura l-uġigħ mill-inqas 15-il minuta qabel NexoBrid jiġi applikat.
English: Animal studies are insufficient to properly assess the potential of NexoBrid to interfere with embryonal/foetal development (see section 5.3).
Maltese: Studji f'annimali mhux biżżejjed biex jevalwaw kif suppost il-potenzjal ta' NexoBrid li jinterferixxi mal-iżvilupp embrijonali/tal-fetu (ara sezzjoni 5.3).
English: NexoBrid 2 g powder and gel for gel Concentrate of proteolytic enzymes enriched in bromelain
Maltese: NexoBrid 2 g trab u ġell għal ġell Konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain
English: 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).
Maltese: 2 g trab f'kunjett (ħġieġ ta' tip II) issiġillat b'tapp tal-lastku (bromobutyl), tapp u miksi b'għatu (aluminju), u 20 g ġell fi flixkun (borosilicate, ħġieġ ta' tip I), issiġillat b'tapp tal-lastku u miksi b'għatu bil-kamin (polypropylene li ma jistax isir tbagħbis fih).
English: • NexoBrid should not be applied to more than 15% (one eighth) of the total body surface.
Maltese: • NexoBrid m'għandux jiġi applikat fuq iktar minn 15% (wieħed minn tmienja) tas-superfiċje totali tal-ġisem.
English: • Other medicines (such as silver sulfadiazine or povidone-iodine) will be removed from the wound area before NexoBrid is applied.
Maltese: • Mediċini oħrajn (bħal silver sulfadiazine jew povidone-iodine) se jitneħħew miż-żona tal-ferita qabel ma NexoBrid jiġi applikat.
English: One vial contains 2 g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (or 2 g/22 g gel).
Maltese: Kunjett wieħed fih 2 g ta' konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain, li jikkorrispondu għal 0.09 g/g ta' konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain wara li jitħallat (jew 2 g/22 g ta' ġell).
English: • All topically applied antibacterial medicinal products must be removed before applying NexoBrid.
Maltese: • Il-prodotti mediċinali antibatterjali kollha applikati b'mod topiku jridu jitneħħew qabel ma tapplika NexoBrid.
English: Wound infection
Maltese: Infezzjonijiet u infestazzjonijiet
English: % wound area autografted 55.5% (n=48)
Maltese: 55.5% (n=48)
English: Store and transport refrigerated (2C-8C).
Maltese: Żommu kiesaħ waqt il-ħażna u l-ġarr (2C-8C).
English: NexoBrid 5 g powder and gel for gel Concentrate of proteolytic enzymes enriched in bromelain
Maltese: NexoBrid 5 g trab u ġell għal ġell Konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain
English: Cross-sensitivity
Maltese: Sensittività inkroċjata
English: NexoBrid was well tolerated when applied to intact mini-pig skin but caused severe irritation and pain when applied to damaged (abraded) skin.
Maltese: NexoBrid kien ittollerat tajjeb meta applikat fuq ġilda intatta tal-mini-pig, iżda kkawża irritazzjoni severa u wġigħ meta ġie applikat fuq ġilda bil-ħsara (misluħa).
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..
Maltese: Flimkien ma' dan, reazzjoni talġilda allerġika ta' tip li jittardja (keilite) wara esponiment tal-ġilda għal tul akbar ta' żmien (mouthwash) kif ukoll sensibilizzazzjoni ssuspettata wara espożizzjoni orali u wara espożizzjoni ripetuta tal-passaġġ tan-nifs fuq il-post tax-xogħol.
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.
Maltese: Fi studji fejn l-analġesija ġiet ipprovduta lil pazjenti kkurati b'NexoBrid fuq bażi li tingħatalhom meta jitolbuha, uġigħ lokali ġie rrappurtat fi 23.3% tal-pazjenti kkurati b'NexoBrid u fi 11.4% tal-pazjenti tal-kontroll.
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.
Maltese: Reazzjonijiet allerġiċi għal bromelain jinkludu reazzjonijiet anafilattiċi u reazzjonijiet oħrajn tat-tip immedjat b'manifestazzjonijiet bħal bronkospażmu, anġjoedema, urtikarja, u reazzjonijiet tal-mukuża u gastrointestinali.
English: What NexoBrid contains - The active substance (in the powder in the vial) is a concentrate of proteolytic enzymes enriched in bromelain: 5 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
Maltese: X'fih NexoBrid - Is-sustanza attiva (fit-trab fil-kunjett) hu konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain: 5 g, li jikkorrispondu għal 0.09 g/g ta' konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain wara li jitħallat.
English: Excipients for the gel: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, water for injections.
Maltese: Eċċipjenti għall-ġell: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, ilma għallinjezzjonijiet.
English: In embryo-foetal development studies in rats and rabbits, intravenously administered NexoBrid revealed no evidence of indirect and direct toxicity to the developing embryo/foetus.
Maltese: Fi studji dwar l-iżvilupp embrijofetali fil-firien u l-fniek, NexoBrid mogħti ġol-vini ma żvela l-ebda evidenza ta' tossiċità indiretta u diretta lill-embriju/fetu li kien qed jiżviluppa.
English: • NexoBrid will be applied to a wound area that is clean, blister free, and moist.
Maltese: • NexoBrid se jiġi applikat fuq żona ta' feriti li tkun nadifa, bla infafet, u umda.
English: 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.
Maltese: NexoBrid hu pprovdut bħala trab u ġell għal ġell (trab f'kunjett (5 g) u ġell fi flixkun (50 g)), daqs talpakkett ta' 1 (pakkett ikun fih kunjett wieħed ta' trab u flixkun wieħed ta' ġell).
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.
Maltese: Tnaqqis fl-aggregazzjoni tal-plejtlits u livelli ta' fibrinoġen fil-plażma u żieda moderata fil-ħinijiet ta' tromboplastin parzjali u ta' protrombin ġew irrappurtati bħala effetti possibbli wara l-għoti orali ta' bromelain.
English: 5 g NexoBrid powder mixed in 50 g gel is applied to a burn wound area of 250 cm It should be left for 4 hours, and then be removed.
Maltese: 5 g NexoBrid trab imħallat f'50 g ta' ġell jiġi applikat fuq żona ta' ferita kkaġunata minn ħruq ta' 250 cm
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).
Maltese: Fi studji kliniċi ta' fażi 2 u fażi 3, ċerti tipi ta' kumplikazzjonijiet ta' feriti ġew irrappurtati b'mod iktar frekwenti fil-grupp ta' NexoBrid milli fil-grupp ikkurat skont is-siti tal-istudju Standard of Care (SOC).
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.
Maltese: Infużjoni fil-vini waħda ta' soluzzjoni ippreparata minn NexoBrid trab fil-mini-pig kienet ittollerata tajjeb f'livelli ta' doża sa 12 mg/kg (li kisbu livelli ta' plażma ta' 2.5 darbiet tal-livell fil-plażma talbniedem wara l-applikazzjoni tad-dożaġġ kliniku propost għal 15% ta' TBSA), iżda dożi ogħla kienu tossiċi b'mod ċar, u kkawżaw emorraġija f'ħafna tessuti.
English: In NexoBrid studies wounds with visible dermal remnants were allowed to heal by spontaneous epithelialisation.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA < PC: {number}
Maltese: DATA TA' REVIŻJONI TAT-TEST
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).
Maltese: Reazzjonijiet allerġiċi għal bromelain ġew rapportati fil-letteratura medika (li jinkludu reazzjonijiet anafilattiċi u reazzjonijiet oħra tat-tip immedjat b'manifestazzjonijiet bħal bronkospażmu, anġjoedema, urtikarja, u reazzjonijiet fil-mukuża u gastrointestinali).
English: One vial contains 5 g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (or 5 g/55 g gel).
Maltese: Kunjett wieħed fih 5 g ta' konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain, li jikkorrispondu għal 0.09 g/g ta' konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain wara li jitħallat (jew 5 g/55 g ta' ġell).
English: • The method of preparation of NexoBrid and of its application to wound area
Maltese: • Il-metodu ta' preparazzjoni ta' NexoBrid u tal-applikazzjoni tiegħu fuq iż-żona tal-ferita
English: If so, you may also experience allergic reactions to NexoBrid;
Maltese: jista' jkollok ukoll reazzjonijiet allerġiċi għal NexoBrid;
English: Posology 2 g NexoBrid powder in 20 g gel is applied to a burn wound area of 100 cm
Maltese: 2 g NexoBrid trab imħallta f'20 g ta' ġell jiġi applikat fuq żona ta' ferita kkaġunata minn ħruq ta' 100 cm
English: Children and adolescents NexoBrid is not for use in patients younger than 18 years.
Maltese: Tfal u adolexxenti NexoBrid mhuwiex għall-użu f'pazjenti li għandhom inqas minn 18-il sena.
English: Mixed wounds (with partial and full-thickness area) autografted NexoBrid (Number of wounds)
Maltese: Feriti mħallta (bi ħxuna parzjali u ħxuna sħiħa) awtotrapjantati NexoBrid (Numru ta' feriti)
English: Avoid accidental eye exposure.
Maltese: Evita espożizzjoni aċċidentali fl-għajnejn.
English: Store upright.
Maltese: Użu għall-ġilda.
English: 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).
Maltese: Fi studji kliniċi ta' fażi 2 u fażi 3, infezzjonijiet ġenerali (mhux assoċjati ma' feriti. eż. infezzjonijiet fl-apparat urinarju, infezzjonijiet virali) kienu rrappurtati iktar b'mod frekwenti fil-grupp ta' NexoBrid (0.147 avvenimenti għal kull pazjent) milli fil-grupp ikkurati skont SOC (0.079 avvenimenti għal kull pazjent).
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.
Maltese: Standard ta' kura kien jikkonsisti minn qtugħ kirurġiku primarju u/jew tneħħija mhux kirurġika ta' tessut mejjet bl-użu ta' prodotti mediċinali topiċi biex jikkaġuna maċerazzjoni u awtolisi ta' tessut mejjet skont il-prattika standard ta' kull sit tal-istudju.
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.
Maltese: Żieda fir-rata ta' taħbit tal-qalb (li jinkludi takikardija), tnaqqis fl-aggregazzjoni tal-plejtlits u livelli ta' fibrinoġen fil-plażma u żieda moderata fil-ħinijiet ta' tromboplastin parzjali u ta' protrombin ġew irrappurtati fil-letteratura bħala effetti possibbli wara l-għoti orali ta' bromelain.
English: General Infections
Maltese: Infezzjonijiet ġenerali
English: General infections
Maltese: Infezzjonijiet Ġenerali
English: What NexoBrid looks like and contents of the pack NexoBrid is provided as a powder and gel for gel (powder in a vial (2 g) and gel in a bottle (20 g)), pack size of 1 (a pack contains one vial of powder and one bottle of gel)
Maltese: NexoBrid hu pprovdut bħala trab u ġell għal ġell (trab f'kunjett (2 g) u ġell fi flixkun (20 g)), daqs talpakkett ta' 1 (pakkett ikun fih kunjett wieħed ta' trab u flixkun wieħed ta' ġell).
English: • A total wound area of not more than 15% TBSA can be treated by NexoBrid.
Maltese: • Żona totali ta' ferita ta' mhux iktar minn 15% TBSA tista' tiġi kkurata b'NexoBrid.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Maltese: It-tieni applikazzjoni u applikazzjonijiet sussegwenti mhumiex rakkomandati.
English: Removal of NexoBrid
Maltese: Kif jintuża NexoBrid
English: • The fact that patients should be monitored for signs and symptoms of wound and systemic infections
Maltese: • Il-fatt li l-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' infezzjonijiet talferita u infezzjonijiet sistemiċi
English: It is not known if NexoBrid application has any clinically relevant effect on haemostasis.
Maltese: Mhux magħruf jekk l-applikazzjoni ta' NexoBrid għandhiex kwalunkwe effett klinikament rilevanti fuq l-emostasi.
English: Mixed wounds (deep partial and full thickness) Non-autografted mixed wounds
Maltese: Feriti mħallta (feriti bi ħxuna parzjali profonda u bi ħxuna sħiħa)
English: Bromelain may enhance the hypotensive effect of ACE inhibitors, causing larger decreases in blood pressure than expected.
Maltese: Bromelain jista' jkabbar l-effett ipotensiv ta' inibituri ACE, li jikkawża tnaqqis fil-pressjoni taddemm aktar milli mistenni.
English: - wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance.
Maltese: - feriti kontaminati b'sustanzi radjuattivi u sustanzi perikolużi oħrajn biex jiġu evitati reazzjonijiet mal-prodott li ma jistgħux jiġu mbassra u żieda fir-riskju ta' firxa tas-sustanza tossika.
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.
Maltese: Flimkien ma' monitoraġġ ta' rutina għal pazjenti b'feriti kkawżati minn ħruq (eż., sinjali vitali, volum/ilma/stat tal-elettroliti, għadd sħiħ tad-demm, tal-albumina fis-serum u tal-livelli tal-enzimi talfwied), il-pazjenti kkurati b'NexoBrid għandhom jiġu mmonitorjati għal: - Żieda fit-temperatura tal-ġisem.
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)..
Maltese: Biex tiġi evitata irritazzjoni possibbli ta' ġilda mibruxa minn kuntatt involontarju ma' NexoBrid u ħruġ ta' demm possibbli miż-żona tal-ferita, iż-żoni tal-feriti akuti bħal tiċrit tallaħam jew inċiżjonijiet ta' ħruq għandhom jiġu protetti minn saff sterilizzat ta' ingwent jew garżi li jkun fihom ix-xaħam (eż. garża bil-petrolatum).
English: - electrical burns.
Maltese: Aħżen f'pożizzjoni vertikali.
English: In case of eye exposure, exposed eyes must be irrigated with copious amounts of water for at least 15 minutes.
Maltese: Jekk NexoBrid jidħol f'għajnejk, aħsilhom b'ħafna ilma għal mill-inqas 15-il minuta.
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.
Maltese: L-iktar reazzjonijiet avversi tal-użu ta' NexoBrid irrappurtati b'mod komuni huma wġigħ lokali u deni/ipertermija temporanji. Meta NexoBrid intuża f'kors li inkluda analġesija preventiva rakkomandata kif ipprattikat regolarment għal tibdil estensiv ta' garżi f'pazjenti b'feriti kkawżati minn ħruq kif ukoll tgħaddis antibatteriku taż-żona tal-kura qabel u wara l-applikazzjoni ta' NexoBrid (ara sezzjoni 4.2), uġigħ lokali kien irrappurtat fi 3.6% tal-pazjenti, deni/ipertermija kienu rrappurtati f'19.
English: Remaining antibacterial medicinal products may interfere with the activity of NexoBrid by decreasing its efficacy.
Maltese: Il-bqija tal-prodotti mediċinali antibatteriċi jistgħu jinterferixxu mal-attività ta' NexoBrid billi jnaqqsu l-effikaċja tiegħu.
English: Benefit/risk assessment should include consideration of the greater frequency of concomitant disease or other medicinal product therapy in the elderly.
Maltese: Evalwazzjoni tal-benefiċċju/riskju għandha tinkludi konsiderazzjoni tal-frekwenza akbar ta' mard ieħor li l-pazjent ikollu fl-istess ħin jew terapija oħra bi prodotti mediċinali fl-anzjani.
English: There are reports of occupational exposure to bromelain leading to sensitisation.
Maltese: Hemm rapporti ta' espożizzjoni fuq il-post tax-xogħol għal bromelain, li wasslet għal sensibilizzazzjoni.
English: The mixture of enzymes in NexoBrid dissolves burn wound eschar.
Maltese: Ma sarux studji biex jevalwaw l-effetti ta' NexoBrid fuq il-fertilità.
English: All topically applied antibacterial medicinal products must be removed before applying NexoBrid.
Maltese: Il-prodotti mediċinali antibatterjali kollha applikati b'mod topiku jridu jitneħħew qabel ma tapplika NexoBrid.
English: Paediatric population Pharmacokinetic parameters and the extent of absorption have not been studied in children.
Maltese: Il-parametri farmakokinetiċi u l-grad ta' assorbiment ma ġewx studjati fit-tfal.
English: NexoBrid gel preparation (mixing powder with gel)
Maltese: Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)
English: Pain
Maltese: Uġigħ
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).
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet ta' farmakovigilanza kif deskrit fil-Pjan ta' Farmakoviġilanza kif inhu maqbul fil-RMP ppreżentat f'Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti talRMP kif maqbul mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP).
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.
Maltese: Mhux magħruf jekk konċentrat ta' enzimi proteolitiċi arrikkiti fi bromelain jew il-metaboliti tiegħu huma eliminati fil-ħalib tas-sider tal-bniedem.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata bir-riċetta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: Topically applied medicinal products (such as silver sulfadiazine or povidone-iodine) at the wound site must be removed and the wound cleansed prior to NexoBrid application.
Maltese: Prodotti mediċinali applikati b'mod topiku (bħal silver sulfadiazine jew povidone-iodine) fis-sit talferita, iridu jitneħħew u l-ferita trid titnaddaf qabel l-applikazzjoni ta' NexoBrid.
English: Mixed wounds (with partial and full-thickness area) requiring excision/dermabrasion (surgery) NexoBrid
Maltese: valur p Feriti bi ħxuna parzjali profonda li jeħtieġu qtugħ/brix tal-ġilda (operazzjoni)