FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals in specialist burn centres who are expected to use and/or prescribe NexoBrid receive a specific training and are provided with an Educational pack.
Croatian: Nositelj odobrenja za stavljanje lijeka će osigurati da prilikom stavljanja lijeka u promet svi zdravstveni djelatnici u specijaliziranim centrima za opekline za koje se očekuje da će koristiti/ili propisivati NexoBrid budu obučeni te će im isporučiti edukacijski paket.
English: Preparation of patient and wound area
Croatian: Priprema bolesnika i područja rane
English: Instructions for the preparation of the NexoBrid gel are given at the end of this leaflet in the section intended for medical or healthcare professionals.
Croatian: Upute za pripremu gela NexoBrid nalaze se na kraju ove upute u dijelu namijenjenom samo zdravstvenim radnicima.
English: Other medicines and NexoBrid Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • The fact that NexoBrid may cause an allergic reaction, an increased tendency to bleed and severe local irritation and that patients should be monitored for signs or symptoms of these
Croatian: • Činjenica da NexoBrid može uzrokovati alergijsku reakciju, povećanu sklonost krvarenju i jaku lokalnu iritaciju te da bolesnike treba nadzirati na znakove ili simptome tih stanja
English: NexoBrid must not be used: - if you are allergic to bromelain - if you are allergic to pineapples - if you are allergic to papain - if you are allergic to any of the other ingredients of the powder or gel (listed in section 6).
Croatian: NexoBrid se ne smije primjenjivati: - ako ste alergični na bromelain - ako ste alergični na ananas - ako ste alergični na papain - ako ste alergični na neki drugi sastojak ovog praška ili gela (naveden u dijelu 6).
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Croatian: Prema smjernicama CHMP-a za Sustave upravljanja rizicima za lijekove za humanu uporabu, dopunjeni RMP mora se podnijeti istovremeno uz sljedeće Periodičko izvješće o neškodljivosti lijeka (PSUR).
English: NexoBrid should be left in contact with the burn for a duration of 4 hours.
Croatian: NexoBrid treba ostati u dodiru s opeklinom 4 sata.
English: After treatment with NexoBrid your doctor may check your blood coagulation levels.
Croatian: Nakon liječenja NexoBridom, liječnik Vam može provjeriti sposobnost zgrušavanja krvi.
English: What NexoBrid is and what it is used for What you need to know before NexoBrid is used How NexoBrid is used
Croatian: Što je NexoBrid i za što se koristi Što morate znati prije nego počnete primjenjivati NexoBrid Kako primjenjivati NexoBrid
English: • You will be given appropriate medicine to prevent and treat pain at least 15 minutes before NexoBrid is applied.
Croatian: • Dobit ćete odgovarajuće lijekove za sprječavanje i liječenje bola najmanje 15 minuta prije primjene NexoBrida.
English: NexoBrid serum concentrations were determined using a modified sandwich electrochemiluminescence (ECL) immunoassay.
Croatian: Koncentracije NexoBrida u serumu utvrdile su se pomoću modificirane sendvič-metode elektrokemiluminiscentnog (ECL) imunološkog određivanja.
English: Patients should be monitored for possible signs of coagulation abnormalities.
Croatian: Bolesnike treba pratiti zbog mogućih znakova poremećaja koagulacije.
English: All randomised patients for whom data for complete wound closure were available.
Croatian: Svi randomizirani bolesnici s dostupnim podacima o potpunom zatvaranju rane.
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).
Croatian: Zbog sigurnosnih pitanja (vidjeti također dio 4.4, Koagulopatija) NexoBrid se ne smije primjenjivati na više od 15% cjelokupne površine tijela (TBSA).
English: - increase drowsiness when used at the same time with medicines that can cause drowsiness.
Croatian: - pojačati omamljenost kad se koristi istovremeno s lijekovima koji mogu prouzročiti omamljenost.
English: According to a literature report, in plasma, approximately 50% of bromelain binds to the human plasma antiproteinases α2-macroglobulin and α1-antichymotrypsin.
Croatian: Prema podacima u literaturi približno se 50% bromelaina u plazmi veže za ljudske antiproteinaze α2-makroglobulin i α1-antikimotripsin u plazmi.
English: No interaction studies with NexoBrid have been performed.
Croatian: Nisu provedena ispitivanja interakcija s NexoBridom.
English: If so, you may also experience allergic reactions to NexoBrid;
Croatian: U tom slučaju možete dobiti i alergijsku reakciju na NexoBrid.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with NexoBrid in one or more subsets of the paediatric population in the treatment of burns of external body surface (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka NexoBrid u jednoj ili više podskupina pedijatrijske populacije u liječenju opeklina vanjske površine tijela (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable.>
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Nije primjenjivo.
English: The most commonly reported adverse reactions of the use of NexoBrid are local pain and transient pyrexia/hyperthermia.
Croatian: Najčešće zabilježene nuspojave primjene NexoBrida su lokalna bol i prolazna pireksija/hipertermija.
English: (mean ± SD)
Croatian: (srednja vrijednost ± SD)
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.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će provesti ispitivanje enzimatskog debridmana u bolesnika s opeklinama (djece i odraslih): Usporedba sa standardnim protokolom skrbi (protokol MW2010-03-03), na temelju protokola koji je odobrio CHMP.
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.
Croatian: Preosjetljivost na djelatnu tvar, ananas ili papain (vidjeti također dio 4.4) ili na neku od pomoćnih tvari navedenih u dijelu 6.1.
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
Croatian: • Rizik od alergijske reakcije i križne reaktivnosti te kontraindikacije u bolesnika alergičnih na ananas i papain ili na prethodnu primjenu lijeka
English: Serious allergic reactions including anaphylaxis
Croatian: ozbiljne alergijske reakcije uključujući anafilaksiju
English: Caution and monitoring is therefore needed when prescribing concomitant medicinal products that affect coagulation.
Croatian: Stoga je potreban oprez i praćenje bolesnika kad se istovremeno propisuju lijekovi koji utječu na koagulaciju.
English: • The method of preparation of NexoBrid and of its application to wound area
Croatian: • Način pripreme NexoBrida i njegova primjena na područje rane
English: Using NexoBrid may reduce the need for, or the extent of, surgical removal of burnt tissue and/or skin transplantation.
Croatian: Primjena NexoBrida može smanjiti potrebu ili opseg kirurškog uklanjanja opečenog tkiva i/ili transplantacije kože.
English: Animal studies are insufficient to properly assess the potential of NexoBrid to interfere with embryonal/foetal development (see section 5.3).
Croatian: Ispitivanja na životinjama su nedostatna da bi se ispravno procijenila mogućnost utjecaja NexoBrida na embrionalni/fetalni razvoj (vidjeti dio 5.3).
English: Pharmacotherapeutic group: Preparations for treatment of wounds and ulcers, proteolytic enzymes; ATC code: D03BA03
Croatian: Farmakoterapijska skupina: pripravci za liječenje rana i čireva, proteolitički enzimi; ATK oznaka: D03BA03
English: There is limited pharmacokinetic data in patients with TBSA of more than 15%.
Croatian: Postoje ograničeni farmakokinetički podaci u bolesnika s opečenom ukupnom površinom tijela većom od 15%.
English: The following table shows the time to complete wound closure from start of debridement.
Croatian: Sljedeća tablica pokazuje vrijeme potrebno za potpuno zatvaranje rane od početka debridmana.*
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.
Croatian: Opseg sustavne apsorpcije iz opekline, Cmax, Tmax, AUC i t½ bromelaina iz NexoBrida ispitani su u 16 bolesnika s termičkim opeklinama djelomične debljine kože (srednje i duboke dermalne opekline).
English: An asterisk (*) indicates that additional information on the respective adverse reaction is provided below the list of adverse reactions.
Croatian: Zvjezdica (*) znači da su za tu nuspojavu navedene dodatne informacije ispod popisa nuspojava.
English: If the tamper-evident ring was already separated from the cap before opening, the gel bottle must be discarded and another, new gel bottle used.
Croatian: Ako je sigurnosni prsten već bio odvojen od zatvarača prije otvaranja, bocu s gelom morate baciti i upotrijebiti drugu, novu bocu s gelom.
English: It is not known if NexoBrid application has any clinically relevant effect on haemostasis.
Croatian: Nije poznato ima li primjena NexoBrida ikakav klinički važan učinak na hemostazu.
English: These results for Cmax and AUClast indicate that systemic absorption may depend both on the applied NexoBrid dose (proportional to the covered wound area) and other, patient-specific factors.
Croatian: Ovi rezultati za Cmax i AUCzadnji pokazuju da sustavna apsorpcija može ovisiti i o primijenjenoj dozi NexoBrida (proporcionalno pokrivenoj površini rane) i drugim čimbenicima svojstvenima bolesniku.
English: NexoBrid should be used within 15 minutes after mixing the powder with the gel.
Croatian: NexoBrid treba primijeniti u roku od 15 minuta nakon miješanja praška s gelom.
English: The age range in the group treated with NexoBrid was 4.4 to 55.7 years.
Croatian: Raspon dobi bolesnika u skupini liječenoj NexoBridom iznosio je 4,4 do 55,7 godina.
English: • OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES The MAH shall complete, within the stated timeframe, the following measures:
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog okvira, ispuniti sljedeće mjere:
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation is in place and functioning before and whilst the medicinal product is on the market.
Croatian: Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav prikazan u Modulu 1.8.1 odobrenja za stavljanje gotovog lijeka u promet, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
English: This usually requires mixing the powder and the gel for 1 to 2 minutes.
Croatian: Za to je obično potrebno miješati prašak i gel 1 do 2 minute.
English: This should be taken into account when dosing such products.
Croatian: Ovo treba uzeti u obzir prilikom doziranja tih lijekova.
English: NexoBrid (2 g/100 cm 2, corresponding to 0.02 g/cm 2) was used as described in section 4.2.
Croatian: 2, što odgovara 0,02 g/cm2) se primijenio onako kao je opisano u dijelu 4.2.
English: In several cases adequate healing did not occur and autografting was required at a later date, leading to significant delays in wound closure which is associated with increased risk of wound-related complications.
Croatian: U nekoliko slučajeva nije došlo do odgovarajućeg cijeljenja te je kasnije bilo potrebno presađivanje vlastite kože, što je dovelo do znatno kasnijeg zatvaranja rane koje je povezano s povećanim rizikom od komplikacija rane.
English: Blood pressure should be monitored in patients receiving ACE inhibitors
Croatian: Treba pratiti krvni tlak u bolesnika koji uzimaju ACE inhibitore.
English: NexoBrid was well tolerated when applied to intact mini-pig skin but caused severe irritation and pain when applied to damaged (abraded) skin.
Croatian: NexoBrid se dobro podnosio kod primjene na intaktnu kožu patuljaste svinje, ali je izazvao tešku nadraženost i bol kad se primijenio na oštećenu (abradiranu) kožu.
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.
Croatian: Cmax bio je 6020 ± 5020 ng/ml (srednja vrijednost ± SD) za skupinu od 15 bolesnika, u rasponu od 888 do 15 700 ng/ml.
English: Very rare (<1/10,000)
Croatian: Vrlo rijetko (<1/10 000)
English: Coagulopathy
Croatian: Koagulopatija
English: ITT (Intent To Treat population): all randomized patients The difference in time to complete wound closure is mainly related to the wound care strategy applied by the physician, where an attempt to minimise grafting and allow for spontaneous epithelialisation of the wound areas that still have dermis may prolong time to first autograft (time to autograft: NexoBrid: 14.7 days vs. SOC: 5.9 days) and hence prolong complete wound closure.
Croatian: ITT (populacija planirana za liječenje): svi randomizirani bolesnici Razlika u vremenu do potpunog zatvaranja rane uglavnom je povezana sa strategijom liječenja rane koju je liječnik primijenio, gdje pokušaj da se minimalizira presađivanje i omogući spontana epitelizacija područja rane u kojoj je još prisutan dermis može produljiti vrijeme do prvog presađivanja vlastite kože (vrijeme do presađivanja vlastite kože: NexoBrid: 14,7 dana nasuprot standardnom liječenju: 5,9 dana) i tako produljiti vrijeme do potpunog zatvaranja rane.
English: Bromelain may increase drowsiness caused by some medicinal products (e.g., benzodiazepines, barbiturates, narcotics and antidepressants).
Croatian: Bromelain može povećati omamljenost prouzročenu nekim lijekovima (npr. benzodiazepinima, barbituratima, narkoticima i antidepresivima).
English: NexoBrid may reduce the ability of your blood to form clots, which increases the risk of bleeding.
Croatian: NexoBrid može smanjiti sposobnost zgrušavanja krvi što povećava rizik od krvarenja.
English: This includes proper wound cover for the exposed tissue.
Croatian: To uključuje ispravno pokrivanje tkiva otvorene rane.
English: From a microbiological point of view and as the enzymatic activity of the product decreases progressively following mixing, the reconstituted product should be used immediately after preparation (within 15 minutes).
Croatian: S mikrobiološkog stajališta i s obzirom na to da enzimatsko djelovanje lijeka progresivno slabi nakon miješanja, pripremljeni lijek treba primijeniti odmah nakon pripreme (u roku od 15 minuta).
English: Concentrate of proteolytic enzymes enriched in bromelain is systemically absorbed from burn wound areas (see section 5.2).
Croatian: Koncentrat proteolitičkih enzima obogaćenih bromelainom sistemski se apsorbira iz područja opeklinskih rana (vidjeti dio 5.2).
English: The powder is off-white to light tan and the gel is clear and colourless.
Croatian: Prašak je bjelkaste do svijetlo bež boje, a gel je proziran i bezbojan.
English: The MAH should undertake a controlled distribution of NexoBrid to ensure that the product is not available for use at a centre until at least one surgeon at the centre has received formal training in the use of NexoBrid.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet treba provoditi kontroliranu distirbuciju lijeka NeoxBrid kako bi osigurao da proizvod nije dostupan u centru sve dok barem jedan kirurg u centru nije prošao službenu obuku u primjeni NexoBrida.
English: The use of NexoBrid to remove burnt tissue may lead to fever, to wound inflammation or wound infection, and possibly to general infection.
Croatian: Primjena NexoBrida za uklanjanje opečenog tkiva može dovesti do vrućice, upale ili infekcije rane, a postoji i mogućnost generalizirane infekcije.
English: This is because NexoBrid can be absorbed from the burn wound into the blood stream.
Croatian: To je zato što se NexoBrid može apsorbirati iz opekline u krvotok.
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.
Croatian: U ispitivanjima utjecaja intravenski primijenjenog NexoBrida na embriofetalni razvoj u štakora i kunića nije bilo dokaza neizravnih ili izravnih toksičnih učinaka na razvoj embrija/fetusa.
English: Direct contact of NexoBrid with the eyes should be avoided.
Croatian: Treba izbjegavati izravni dodir NexoBrida s očima.
English: The treated area must be rubbed until the appearance of a pinkish surface with bleeding points or a whitish tissue.
Croatian: Liječeno područje mora se trljati sve dok se ne pojavi ružičasta površina s točkastim krvarenjem ili bjeličasto tkivo.
English: Elimination:
Croatian: Eliminacija:
English: Do not use NexoBrid after the expiry date which is stated on the label of the vial, bottle, and box after “EXP”.
Croatian: NexoBrid se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice, boce i kutije nakon “Rok valjanosti”.
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.
Croatian: Cmax od 40 µg/ml može se postići u ljudi nakon primjene NexoBrida prema uvjetima odobrenja, kad se uzme u obzir da je farmakokinetika bila procijenjena samo u bolesnika s pretežno površinskim opeklinama koji su primili polovicu maksimalne doze.
English: If too much NexoBrid is used If too much NexoBrid gel is applied on a burn wound, excess gel may be wiped off.
Croatian: Ako se nanese previše gela NexoBrid na opeklinsku ranu, suvišak gela može se obrisati.
English: The available data are limited and NexoBrid should not be used in patients younger than 18 years.
Croatian: Dostupni podaci su ograničeni te Nexobrid ne treba koristiti u bolesnika mlađih od 18 godina.
English: As a precautionary measure, you should not breast-feed for at least 4 days after NexoBrid application.
Croatian: Kao mjeru opreza, ne biste smjeli dojiti tijekom najmanje 4 dana nakon primjene NexoBrida.
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Priprema i primjena
English: No studies were performed to assess the effects of NexoBrid on fertility.
Croatian: Nisu provedena ispitivanja procjene učinaka NexoBrida na plodnost.
English: There is very limited information on the use of NexoBrid on areas where eschar remained after the first application.
Croatian: Podaci o primjeni NexoBrida na područja na kojima je eshar ostao nakon prve primjene vrlo su ograničeni.
English: Breast-feeding should be discontinued at least 4 days from NexoBrid application initiation.
Croatian: Dojenje treba prekinuti na najmanje 4 dana od početka primjene NexoBrida.
English: NexoBrid may: - increase the effects of certain medicines that are inactivated by a liver enzyme called CYP2C8 and CYP2C9.
Croatian: NexoBrid može: - pojačati učinke određenih lijekova koje razgrađuju enzimi jetre koji se zovu CYP2C8 i CYP2C9.
English: In vitro and animal data suggest that bromelain can also promote fibrinolysis.
Croatian: In vitro podaci i podaci iz ispitivanja na životinjama pokazuju da bromelain može poticati i fibrinolizu.
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.
Croatian: Terminalni poluvijek (određen iz podataka za razdoblje od 16 do 48 sati nakon doze u 12 bolesnika) iznosio je 11,7 ± 3,5 sati (srednja vrijednost ± SD), uz raspon od 8,5 do 19,9 sati.
English: This usually requires mixing the NexoBrid powder and the gel for 1 to 2 minutes.
Croatian: Za to je obično potrebno miješati prašak NexoBrid i gel 1 do 2 minute.
English: • The limitation of the total area than can be treated to 15% TBSA
Croatian: • Ograničenje ukupnog područja koje se može liječiti na 15% cjelokupne površine tijela
English: In NexoBrid studies wounds with visible dermal remnants were allowed to heal by spontaneous epithelialisation.
Croatian: U ispitivanjima NexoBrida ranama s vidljivim ostacima kože omogućilo se cijeljenje spontanom epitelizacijom.
English: During clinical development, a total of 362 patients were treated with the concentrate of proteolytic enzymes enriched in bromelain.
Croatian: Tijekom kliničkog razvoja ukupno je 362 bolesnika bilo liječeno koncentratom proteolitičkih enzima obogaćenih bromelainom.
English: Common side effects (may affect up to 1 in 10 people) - Pain (even if medicines are used to prevent or lessen pain caused by the removal of burnt tissue) - Infection of the burn wound - Complications of the wound including; wound opening, wounds drying out and breaking down and failure of skin grafts to heal properly
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - bol (čak i ako se primijene lijekovi za sprječavanje ili ublažavanje bolova prouzročenih uklanjanjem opečenog tkiva) infekcija opekline - komplikacije rane uključuju: otvaranje rane, sušenje rane i pucanje te nepravilno cijeljenje presadaka kože.
English: The comparisons in mixed wounds should be interpreted with caution since they are based on groups that are not fully randomized and the mixed wounds treated by NexoBrid were overall larger and had a larger full thickness area.
Croatian: Usporedbe u mješovitih rana treba interpretirati s oprezom jer se temelje na skupinama koje nisu potpuno randomizirane, a mješovite su rane liječene Nexobridom bile ukupno veće i imale su veće područje zahvaćanja pune debljine kože.
English: There is no experience of the use of NexoBrid on: - perineal and genital burns.
Croatian: Ne postoji iskustvo s primjenom NexoBrida na: - opekline u perinealnom i genitalnom području. - električne opekline.
English: The PSUR cycle for the medicinal product should follow the standard requirements until otherwise agreed by the CHMP.
Croatian: Podnošenje PSUR-a za lijek trebalo bi pratiti standardne zahtjeve do drugačije dogovorenog od strane CHMP-a.
English: There are reports of occupational exposure to bromelain leading to sensitisation.
Croatian: Zabilježeno je profesionalno izlaganje bromelainu koje je dovelo do senzibilizacije.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: Recommendations for safe handling
Croatian: Preporuke za sigurno rukovanje
English: What NexoBrid is
Croatian: Što je NexoBrid
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).
Croatian: To treba uzeti u obzir ako se NexoBrid primjenjuje u bolesnika koji primaju supstrate CYP2C8 (uključujući amiodaron, amodiakvin, klorokin, fluvastatin, paklitaksel, pioglitazon, repaglinid, roziglitazon, sorafenib i torasemid) i supstrate CYP2C9 (uključujući ibuprofen, tolbutamid, glipizid, losartan, celekoksib, varfarin i fenitoin).