FrancophonIA/ELRC3.0 huggingface dataset:
English: With regards to the risk of hepatitis B reactivation, since chronic hepatitis B infection (HbsAg+) was generally considered an exclusion criterion and the collection of data regarding HBV serology and DNA was not mandatory in the development programme of DAAs agents, there is limited information on hepatitis B reactivation obtainable from the completed clinical trials.
Danish: Med hensyn til risikoen for hepatitis B-reaktivering findes der kun begrænsede oplysninger om hepatitis B-reaktivering fra de gennemførte kliniske forsøg, da kronisk hepatitis B infektion (HbsAg+) generelt blev betragtet som et eksklusionskriterium, og indsamlingen af data mht. HBV-serologi og DNA ikke var obligatorisk i udviklingsprogrammet for DAA-lægemidler.
English: The reactivation may occur mostly in subjects with detectable HBsAg and active HBV replication of any level, as evaluated by measurable levels of HBV-DNA, but may also occur in subjects without detectable HBsAg though with detectable anti-HBc antibody, of which a small percentage may also present with variable levels of active HBV replication.
Danish: De tilgængelige data giver bevis for, at reaktiveringen af HBV-replikation kan forekomme i forbindelse med behandling af kronisk, aktiv HCV-infektion med en hvilken som helst effektiv behandling hos patienter co-inficeret med HBV og HCV. Reaktiveringen kan hovedsageligt forekomme hos patienter med påviseligt HBsAg og aktiv HBV-replikation uanset niveau, vurderet ud fra påviselige niveauer af HBV-DNA, men kan også forekomme hos patienter uden påviseligt HBsAg, dog med påviseligt antiHBc-antistof, og hvor en lille procentdel også kan have aktiv HBV-replikation på forskelligt niveau.
English: Still, it was considered that the impact of DAAs therapies on the incidence and type of de novo HCC should be further investigated by the MAHs through a prospective cohort study to be conducted in HCV infected patients with compensated cirrhosis (CPT-A) without history of HCC and treated with DAAs.
Danish: Alligevel fandtes det, at DAA-behandlingernes indvirkning på incidensen og typen af de novo HCC skal undersøges nærmere af indehaverne af markedsføringstilladelserne gennem en prospektiv kohorte-undersøgelse.
English: Such effects could still be seen after the recovery period of 2 weeks.
Danish: Sådanne virkninger kunne stadig ses efter rekonvalescensperioden på 2 uger.
English: This is in addition to the educational material which all potential users should receive.
Danish: Dette er i tillæg til det uddannelsesmateriale, som alle potentielle brugere bør få udleveret.
English: The specific components responsible for this effect have not been identified.
Danish: De specifikke komponenter, der er ansvarlige for denne virkning, er ikke blevet identificeret.
English: You may be checked regularly for these conditions.
Danish: Du kan blive kontrolleret regelmæssigt for disse reaktioner.
English: Average TBSA was 10%.
Danish: I gennemsnit var TBSA 10 %.
English: Burns for which there is limited or no experience
Danish: Forbrændinger, hvor der er begrænset eller ingen erfaring
English: Immune system disorders Not known:
Danish: Immunsystemet Ikke kendt:
English: Allergic reactions can be severe and require medical treatment.
Danish: Allergiske reaktioner kan være svære og kræve medicinsk behandling.
English: It will be prepared directly before use and applied by a doctor or another healthcare professional.
Danish: Det vil forberedes umiddelbart før brug og appliceres af en læge eller andet sundhedspersonale.
English: The educational pack should contain the following:
Danish: Uddannelsespakken skal indeholde det følgende:
English: The wound must be kept moist during the application procedure.
Danish: Såret skal holdes fugtigt i løbet af applikationsproceduren.
English: Very common side effects (may affect more than 1 in 10 people) - Fever
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - Feber
English: *These comparisons should be interpreted with caution since they are based on groups that are not fully randomized.
Danish: *Disse sammenligninger bør fortolkes med forsigtighed, da der er baseret på grupper, som ikke er helt randomiserede.
English: Preparation and administration
Danish: Forberedelse og administration
English: A second and subsequent application is not recommended.
Danish: En anden og efterfølgende applikation anbefales ikke.
English: ** Informed Consent Form
Danish: ** Informeret samtykkeerklæring
English: There is limited pharmacokinetic data in patients with TBSA of more than 15%.
Danish: Der er begrænsede farmakokinetiske data hos patienter med et TBSA på over 15 %.
English: Experience with NexoBrid in elderly patients (>65 years) is limited.
Danish: Erfaring med NexoBrid hos ældre patienter (>65 år) er begrænset.
English: The following table shows results in mixed wounds.
Danish: Den følgende tabel viser resultater for blandede sår.
English: You may receive medicines to prevent or treat infections.
Danish: Du kan få medicin for at forebygge og behandle infektioner.
English: Paediatric population Pharmacokinetic parameters and the extent of absorption have not been studied in children.
Danish: Pædiatrisk population Farmakokinetiske parametre og absorptionsgraden er ikke blevet undersøgt hos børn.
English: - chemical burn wounds.
Danish: - kemiske brandsår.
English: Since NexoBrid was poorly tolerated by the parent animals, these studies are not considered relevant for human risk assessment.
Danish: Da NexoBrid blev tolereret dårligt af parentaldyrene, anses disse studier ikke for at være relevante for human risikovurdering.
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.
Danish: Fra disse data forventes det, at den samlede sikkerhedsprofil hos børn i alderen 4 år og derover og hos unge er sammenlignelig med profilen hos voksne.
English: - Signs of local or systemic allergic reactions.
Danish: - Tegn på lokale eller systemiske allergiske reaktioner.
English: The following definitions apply to the frequency terminology used hereafter: Very common (≥1/10)
Danish: De følgende definitioner gælder for hyppighedsterminologien, som herefter anvendes: Meget almindelig (≥ 1/10)
English: These patients should be carefully monitored.
Danish: Disse patienter skal overvåges nøje.
English: See section 6.6 for instructions on NexoBrid gel preparation.
Danish: 6.6 for instruktioner i forberedelse af NexoBrid gel.
English: All wounds (ITT
Danish: Alle sår (ITT
English: There is only limited safety data from the use in the paediatric population.
Danish: Der er kun begrænsede sikkerhedsdata fra brugen i den pædiatriske population.
English: The Healthcare Professional information pack should be a step by step treatment guide that includes information on the following key elements:
Danish: Informationspakken til sundhedspersonale er en trinvis behandlingsguide, der indeholder information om de følgende nøgleelementer:
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}.>
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
English: • The risk of increased mortality in patients with cardiopulmonary diseases
Danish: • Risikoen for øget mortalitet hos patienter med hjerte-lunge-sygdomme
English: This is to make it less likely that you develop an allergic reaction to NexoBrid.
Danish: Dette er for at gøre det mindre sandsynligt, at du udvikler en allergisk reaktion over for NexoBrid.
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).
Danish: Fra et mikrobiologisk synspunkt og da den enzymatiske aktivitet af præparatet reduceres progressivt efter blanding, skal det rekonstituerede præparat anvendes umiddelbart efter forberedelse (i løbet af 15 minutter).
English: The frequency of pain and pyrexia/hyperthermia was higher without these precautionary measures (see below).
Danish: Hyppigheden af smerter og pyreksi/hypertermi var større uden disse forholdsregler (se nedenfor).
English: Tmax for 10 of the 15 patients was 2 hours and in 5 patients Tmax was 4 hours.
Danish: Tmax for 10 ud af de 15 patienter var 2 timer og hos 5 patienter var Tmax 4 timer.
English: • Appropriate preventive analgesia medicinal products must be administered.
Danish: • Passende analgetiske lægemidler skal administreres.
English: If you are not sure whether you are taking any of the medicines mentioned above, ask your doctor before NexoBrid is used.
Danish: Hvis du ikke er sikker på, om du tager nogle af de ovenfor nævnte lægemidler, skal du spørge lægen, før NexoBrid bruges.
English: An asterisk (*) indicates that additional information on the respective adverse reaction is provided below the list of adverse reactions.
Danish: En stjerne (*) indikerer, at yderligere information om de respektive bivirkninger gives nedenunder listen over bivirkninger.
English: It should be used within 15 minutes after mixing.
Danish: Det bør anvendes i løbet af 15 minutter efter blanding.
English: 48 wounds
Danish: 48 sår
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.
Danish: - sår, der er forurenet med radioaktive og andre farlige stoffer, for at undgå uforudsete reaktioner med præparatet, og en øget risiko for at sprede det skadelige stof.
English: The age range in the SOC group was 5.1 to 55.7 years.
Danish: Aldersintervallet i SOC-gruppen var 5,1 til 55,7 år.
English: • The need for pain management
Danish: • Behovet for smertebehandling
English: The powder should not be inhaled.
Danish: Pulveret må ikke indåndes.
English: No dose adjustment is required.
Danish: En dosisjustering er ikke nødvendig.
English: Prior to launch in each Member State, the Marketing Authorisation Holder MAH shall agree the content and format of the educational programme with the national competent authority.
Danish: Før markedsføring i hvert medlemsland, skal indehaveren af markedsføringstilladelsen (MAH) nå til enighed om indholdet og formatet af uddannelsesprogrammet med den nationale kompetente myndighed.
English: Serious allergic reactions including anaphylaxis
Danish: Alvorlige allergiske reaktioner, herunder anafylakse
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).
Danish: Maternale eksponeringsniveauer var imidlertid betydeligt lavere end de maksimalt rapporterede i klinisk regi (10-500 gange lavere end human AUC, 3-50 gange lavere end human Cmax).
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.
Danish: Anvisninger i forberedelse af NexoBrid gel gives sidst i denne indlægsseddel i det afsnit, der er tiltænkt læger og sundhedspersonale.
English: The following table shows the time to complete wound closure from start of debridement.
Danish: Den følgende tabel viser tiden til fuldstændig sårlukning fra debrideringen påbegyndes.
English: NexoBrid must be used with caution in such patients.
Danish: NexoBrid bør anvendes med forsigtighed hos sådanne patienter.
English: Date of first authorisation: 18.12.2012 Date of latest renewal: 10.11.2017
Danish: Dato for første markedsføringstilladelse: 18 December 2012 Dato for seneste fornyelse: 10. November 2017
English: Preparation of patient and wound area
Danish: Forberedelse af patient og sårområde
English: NexoBrid serum concentrations were determined using a modified sandwich electrochemiluminescence (ECL) immunoassay.
Danish: NexoBrid serum-koncentrationerne blev bestemt ved hjælp af en modificeret sandwich electrochemiluminescence (ECL) immunoassay.
English: 60 wounds
Danish: 60 sår
English: • The wound assessment and the warning against any repeat treatment
Danish: • Vurdering af såret og advarsel mod gentagen behandling
English: All randomised patients for whom data for complete wound closure were available.
Danish: Alle randomiserede patienter, hvor der er tilgængelige data om fuldstændig sårlukning.
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.
Danish: Disse resultater for Cmax og AUClast indikerer, at systemisk absorption både kan afhænge af den applicerede NexoBrid-dosis (proportional med det dækkede sårområde) og andre patientspecifikke faktorer.
English: Benefit/risk assessment should include consideration of the greater frequency of concomitant disease or other medicinal product therapy in the elderly.
Danish: En vurdering af risk/benefitforholdet skal tage den større hyppighed af samtidig sygdom eller anden lægemiddelbehandling hos ældre i betragtning.
English: In 4 patients, having received a dose of 5, 9, 12 and 17 g, respectively, there were indications of markedly higher systemic absorption.
Danish: Hos 4 patienter, der fik en dosis på hhv. 5, 9, 12 og 17 g, var der indikationer for markant højere systemisk absorption.
English: Sensitisation may have occurred due to inhalation of bromelain powder.
Danish: Sensibiliseringen kan have opstået på grund af indånding af bromelain-pulver.
English: See also section 4.2 and 4.8.
Danish: 4.2 og 4.8.
English: Recommendations for safe handling
Danish: Anbefalinger til sikker håndtering
English: • The fact that patients should be monitored for signs and symptoms of wound and systemic infections
Danish: • Det faktum, at patienterne skal overvåges for tegn og symptomer på sårinfektion og systemisk infektion
English: Local pain*
Danish: Lokale smerter*
English: Direct contact with the eyes should be avoided.
Danish: Direkte kontakt med øjnene bør undgås.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor or pharmacist before this medicine is used.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du bruger dette lægemiddel.
English: - Signs of local and systemic inflammatory and infectious processes.
Danish: - Tegn på lokale og systemiske inflammatoriske og infektiøse processer.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: In vitro and animal data suggest that bromelain can also promote fibrinolysis.
Danish: In vitro-data og data fra dyrestudier tyder på, at bromelain også kan fremme fibrinolyse.
English: - Potential effects on haemostasis (see above).
Danish: - Mulig påvirkning af hæmostasen (se ovenfor).
English: Warnings and precautions Talk to your doctor or nurse before NexoBrid is used if
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før NexoBrid bruges, hvis
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.
Danish: Sammenligninger for blandede sår bør fortolkes med forsigtighed, da de er baseret på grupper, som ikke er helt randomiserede, og de blandede sår, der blev behandlet med NexoBrid, var generelt større og havde større områder af fuld tykkelse.
English: (mean ± SD)
Danish: SD)
English: These medicines include, for example, sleep medications, so-called tranquilizers, some pain medications and antidepressants.
Danish: Disse lægemidler omfatter f.eks. sovemedicin, såkaldte beroligende midler, nogle smertelindrende midler og antidepressiva.
English: Patients should be monitored for increased toxicity.
Danish: Patienterne skal overvåges for øget toksicitet.
English: Pyrexia/hyperthermia
Danish: Pyreksi/hypertermi
English: SOC (Number of wounds)
Danish: SOC (antal sår)
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
Danish: • Det faktum, at NexoBrid kan forårsage en allergisk reaktion, en øget tendens til blødning og svær lokal irritation, og at patienterne skal overvåges for sådanne tegn og symptomer
English: No interaction studies with NexoBrid have been performed.
Danish: Der er ikke udført interaktionsstudier med NexoBrid.
English: Bromelain may enhance the hypotensive effect of ACE inhibitors, causing larger decreases in blood pressure than expected.
Danish: Bromelain kan forstærke den hypotensive virkning af ACE-hæmmere, og forårsage større sænkninger af blodtrykket end forventet.
English: Monitoring
Danish: Overvågning
English: Caution and monitoring is therefore needed when prescribing concomitant medicinal products that affect coagulation.
Danish: Det er derfor nødvendigt at udvise forsigtighed og udføre kontroller, når der ordineres samtidige lægemidler, der påvirker koagulationen.
English: If too much NexoBrid is used If too much NexoBrid gel is applied on a burn wound, excess gel may be wiped off.
Danish: Hvis der bruges for meget NexoBrid Hvis der appliceres for meget NexoBrid på et brandsår, kan den overskydende gel tørres af.
English: - increase drowsiness when used at the same time with medicines that can cause drowsiness.
Danish: - Øge døsighed, når de anvendes på samme tid som medicin, der kan forårsage døsighed.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Danish: Læger og sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: After treatment with NexoBrid your doctor may check your blood coagulation levels.
Danish: Efter behandling med NexoBrid kan din læge kontrollere dit blods størkningsevne.
English: The age range in the group treated with NexoBrid was 4.4 to 55.7 years.
Danish: Aldersintervallet i gruppen, der blev behandlet med NexoBrid, var 4,4 til 55,7 år.
English: The gel is clear and colourless.
Danish: Gelen er klar og farveløs.
English: This should be taken into account when dosing such products.
Danish: Dette bør overvejes, når sådanne præparater doseres.
English: 60% of the treated wounds area was partial thickness and/or full thickness.
Danish: 60 % af det behandlede sårområde var af delvis tykkelse og/eller af fuld tykkelse.
English: NexoBrid was well tolerated when applied to intact mini-pig skin but caused severe irritation and pain when applied to damaged (abraded) skin.
Danish: NexoBrid var veltolereret efter applikation på intakt mini-grisehud, men forårsagede svær irritation og smerter efter applikation på beskadiget (afskrabet) hud.
English: Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Danish: 4.8 og 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
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.
Danish: I embryoføtale udviklingsstudier med rotter og kaniner viste intravenøst administreret NexoBrid ingen evidens for indirekte eller direkte toksicitet på det udviklende embryo/fostret.
English: • The limitation of the total area than can be treated to 15% TBSA
Danish: • Begrænsningen i det totale område, der kan behandles, er 15 % TBSA
English: The PSUR cycle for the medicinal product should follow the standard requirements until otherwise agreed by the CHMP.
Danish: PSUR'er Lægemidlets PSUR-cyklus skal følge standardbestemmelserne, indtil andet aftales med CHMP.
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.
Danish: Hvis sikringsringen allerede var separeret fra låget før åbning, skal flasken med gel kasseres, og en ny flaske med gel anvendes.
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).
Danish: NexoBrid må ikke bruges: - hvis du er allergisk over for bromelain - hvis du er allergisk over for ananas - hvis du er allergisk over for papain - hvis du er allergisk over for et af de øvrige indholdsstoffer i pulveret eller gelen (angivet i punkt 6).
English: There is very limited information on the use of NexoBrid on areas where eschar remained after the first application.
Danish: Der er meget begrænset information om brugen af NexoBrid på områder, hvor der er sårskorpe tilbage efter den første applikation.
English: Using NexoBrid may reduce the need for, or the extent of, surgical removal of burnt tissue and/or skin transplantation.
Danish: Brug af NexoBrid kan nedsætte behovet for, eller omfanget af, kirurgisk fjernelse af brændt væv og/eller hudtransplantation.
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.
Danish: I flere tilfælde opstod der ikke tilstrækkelig heling, og en autotransplantation var nødvendig på et senere tidspunkt, hvilket førte til betydelige forsinkelser i sårlukning, som forbindes med en øget risiko for sårrelaterede komplikationer.
English: • NexoBrid should not be applied to more than 15% (one eighth) of the total body surface.
Danish: • NexoBrid bør ikke appliceres på over 15 % (en ottendedel) af den samlede kropsoverflade.
English: Efficacy data generated in this study for all age groups combined as well as from a subgroup analysis for children and adolescents are summarised below.
Danish: Data for virkning, der blev genereret i dette studie for alle kombinerede aldersgrupper samt fra en undergruppeanalyse for børn og unge er opsummeret nedenfor.
English: Since the safe use of NexoBrid during pregnancy has not yet been established, NexoBrid is not recommended during pregnancy.
Danish: Da en sikker anvendelse af NexoBrid i løbet af graviditeten endnu ikke er klarlagt, bør NexoBrid ikke anvendes under graviditeten.
English: During the clinical development of NexoBrid, there was no indication of an increased bleeding tendency or bleeding at the site of debridement.
Danish: I løbet af den kliniske udvikling af NexoBrid var der ingen indikation for en øget blødningstendens eller blødning på området med débridement.
English: The potential of NexoBrid (a protein product) to cause sensitisation should be taken into account when re-exposing patients to bromelain-containing products at a later point in time.
Danish: Muligheden for, at NexoBrid (et proteinprodukt) forårsager sensibilisering skal tages med i overvejelserne, når patienterne igen eksponeres over for bromelain-holdige præparater på et senere tidspunkt.
English: Patients should be monitored for possible signs of coagulation abnormalities.
Danish: Patienterne bør overvåges for mulige tegn på koagulationsforstyrrelser.
English: NexoBrid showed no genotoxic activity when investigated in the standard set of in vitro and in vivo studies.
Danish: NexoBrid viste ingen genotoksisk aktivitet efter undersøgelse af standardsættet i in vitro- og in vivo-studier.
English: Eyes should be carefully protected during treatment of facial burns using adhesive barrier petroleum ointment.
Danish: Øjnene skal nøje beskyttes under behandling af ansigtsforbrændinger med en klæbende barriere af petroleumssalve.