FrancophonIA/ELRC3.0 huggingface dataset:
English: A plant toxicity study based on OECD Guideline 208 but not conducted under GLP was provided.
Danish: Der blev fremlagt en undersøgelse af plantetoksiciteten baseret på OECD's retningslinje 208, som dog ikke blev gennemført i henhold til GLP-specifikationerne.
English: Using the data from the above study and the estimated PECsurface water values, all PEC/PNEC ratios were below 1, indicating a low risk for fish.
Danish: Anvendes data fra ovennævnte undersøgelse og de anslåede værdier for PECoverfladevand, var alle PEC/PNEC-forhold under 1, hvilket tyder på en lav risiko for fisk.
English: The data provided did not indicate a risk regarding soil invertebrates.
Danish: De fremlagte data tydede ikke på en risiko for hvirvelløse dyr i jorden.
English: Partial chlorosis, extensive chlorosis and extensive chlorosis with leaf wilt was seen with all plant species in at least one test concentration, however information on phytotoxicity was not presented for the controls, so it was concluded that this criterion was not met. As the results of the control seedlings were not reported it is not possible to conclude if the mean survival of emerged control seedlings is at least 90% for the duration of the study as required by the OECD guidance.
Danish: Delvis klorose, omfattende klorose og omfattende klorose med bladvisnen sås hos alle plantearter ved mindst en testkoncentration, men der blev ikke fremlagt information om fytotoksicitet for kontrolgruppen, så det blev konkluderet, at kriteriet ikke var opfyldt.
English: • In turkeys for the treatment and prevention of infectious sinusitis caused by Mycoplasma gallisepticum.
Danish: • Kalkuner: behandling og forebyggelse af smitsom sinusitis forårsaget af Mycoplasma gallisepticum.
English: Concentrations of tylosin in surface water and groundwater were estimated using methods described in the CVMP Revised Guideline on Environmental Impact Assessment for Veterinary Medicinal Products (EMEA/CVMP/ERA/418282/2005).
Danish: Pharmasin 100 % w/w vandopløseligt granulat blev vurderet ved hjælp af de modeller, der er udviklet af Forum for Co-ordination of Pesticide Models and their Use (FOCUS) som anbefalet i CVMP's "Revised Guideline on Environmental Impact Assessment for Veterinary Medicinal Products" (EMEA/CVMP/ERA/418282/2005).
English: 2.1 Risk to terrestrial compartment
Danish: 2.1 Risikoen for det terrestriske miljø
English: The other two acceptability criteria, seedlings not exhibiting visible phytotoxicity and identical environmental conditions were not met. From the information provided it cannot be shown that any of the required acceptance criteria for this type of study have been met.
Danish: De øvrige to acceptablitetskriterier, nemlig kimplanter, der ikke fremviser synlig fytotoksicitet, og identiske miljøforhold var ikke opfyldt.
English: Based on this EC50 value a PNEC of 4.2 μg/l was calculated (PNEC equal to EC50/100); the assessment factor of 100 is in line with the VICH GL38 guideline.
Danish: På grundlag af denne EC50-værdi blev der beregnet en PNEC på 4,2 μg/l (PNEC svarende til EC50/100).
English: The EC50 from this study was concluded to be greater than 100 mg/l and PNEC (EC50/1000) was concluded to be greater than 100 μg/l; the assessment factor of 1000 is in line with the VICH GL38 guideline.
Danish: Det konkluderedes, at EC50-værdien fra denne undersøgelse var højere end 100 mg/l, og PNECværdien (EC50/1000) konkluderedes at være højere end 100 μg/l.
English: The rate of nitrate production was not provided as required by the OECD guideline; instead the concentration of nitrate at each time point was given.
Danish: Nitratproduktionshastigheden blev ikke opgivet som krævet i OECD's retningslinje.
English: Using this approach Huvepharma NV concluded that the maximum predicted surface water concentration could be revised from 4.44 μg/l to 1.77 μg/l, leading to a TWA PEC/PNEC ratio of 0.42, indicating according to the applicant that Pharmasin 100% W/W Water Soluble Granules does not pose a risk for blue-green algae (cyanobacteria).
Danish: Ved hjælp af denne fremgangsmåde konkluderede Huvepharma NV, at den maksimale forventede koncentration i overfladevandet kunne ændres fra 4,44 μg/l til 1,77 μg/l, hvilket førte til et TWA PEC/PNEC-forhold på 0,42.
English: Using this data and the estimated PECsurface water values, all PEC/PNEC ratios were below 1, indicating a low risk for aquatic invertebrates.
Danish: På grundlag af disse data og de anslåede værdier for PECoverfladevand var PEC/PNEC-forholdet under 1, hvilket tyder på en lav risiko for hvirvelløse vanddyr.
English: • In pigs: for treatment and prevention of porcine intestinal adenomatosis (ileitis) associated with Lawsonia intracellularis and for the treatment and prevention of enzootic pneumonia caused by Mycoplasma hyopneumoniae and Mycoplasma hyorhinis;
Danish: Lawsonia intracellularis og behandling og forebyggelse af enzootisk lungebetændelse forårsaget af Mycoplasma hyopneumoni og Mycoplasma hyorhini
English: 2.2.3 Effects on aquatic invertebrates
Danish: 2.2.3 Virkninger på hvirvelløse vanddyr
English: There were some deviations from the OECD guideline: the biomass in the test soil was lower than required at day 0; it was not clear if the soil had been stored for more than 3 months before the study was carried out; the maximum water holding capacity was not provided so it was not possible to conclude if the soil complied with the requirements for moisture content during the study.
Danish: Der var visse afvigelser fra OECD's retningslinje: Biomassen i forsøgsjorden var lavere end krævet på dag 0.
English: (EC50/1000) was therefore concluded to be 680 μg/l; the assessment factor of 1000 is in line with the VICH GL38 guideline.
Danish: Vurderingsfaktoren på 1000 er i overensstemmelse med VICH's GL38 retningslinje.
English: 2.1.1 Effects on soil invertebrates
Danish: 2.1.1 Virkninger på hvirvelløse dyr i jorden
English: Products
Danish: Lægemiddelform
English: Intention-to-treat (ITT) data set.
Danish: Intention-to-treat (ITT) datasæt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1069/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1069/001
English: Email: info.de@amrytpharma.com
Danish: E-mail: info.de@amrytpharma.com
English: Do not use a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
English: OUTER CARTON and TUBE
Danish: YDERKARTON og TUBE
English: Do not stop using it without consulting your doctor or nurse.
Danish: Stop ikke med at bruge det uden at rådføre dig med lægen eller sygeplejersken.
English: This makes overdose very unlikely, even if applied to large skin areas and for a long period of time.
Danish: Dette gør overdosering meget usandsynlig, selv ved påføring på store hudområder og i lang tid.
English: Your doctor or nurse will tell you for how long you should use the gel.
Danish: Lægen eller sundhedspersonalet vil fortælle dig, hvor længe du skal bruge gelen.
English: The Phase III studies were blindly evaluated, prospective, intra-individually controlled, randomised, multicentre trials.
Danish: Fase III-undersøgelserne var blindevaluerede, prospektive, intraindividuelt kontrollerede, randomiserede multicenterforsøg.
English: Pharmacotherapeutic group: Preparation for treatment of wounds and ulcers; ATC code: D03AX13 .
Danish: Farmakoterapeutisk klassifikation: Præparat til behandling af sår og ulcus; ATC kode: D03AX13.
English: The active substance was not genotoxic in in vitro assays.
Danish: Det aktive stof var ikke genotoksisk i in vitro-assays.
English: Do not use Episalvan - if you are allergic to birch bark or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Episalvan - hvis du er allergisk over for birkebark eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Additional standard treatment may be required (see section 4.5).
Danish: Supplerende standardbehandling kan være nødvendig (se pkt.
English: Marketing Authorisation Holder and Manufacturer Amryt AG
Danish: Indehaver af markedsføringstilladelsen og fremstiller Amryt AG
English: Episalvan can be used during pregnancy.
Danish: Episalvan kan anvendes under graviditet.
English: Other topical products should not be concomitantly used together with Episalvan but rather sequentially or alternatively depending on the clinical need.
Danish: Andre topikale produkter må ikke anvendes samtidig med Episalvan, men i stedet sekventielt eller alternativt, afhængigt af det kliniske behov.
English: Date of first authorisation: 14 January 2016
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 14. januar 2016
English: No dose adjustment is required.
Danish: Dosisjustering er ikke påkrævet.
English: Other side effects include:
Danish: Andre bivirkninger er:
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningernes hyppighed defineres som følger: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Patients with deeper burn wounds (Grade 2b) were not included.
Danish: Der indgik ikke patienter med dybere brandsår (grad 2b).
English: Adverse reactions were administration site reactions only.
Danish: Bivirkningerne bestod udelukkende i reaktioner på administrationsstedet.
English: Episalvan gel is sterile.
Danish: Episalvan gel er steril.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cutaneous use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til kutan anvendelse.
English: Photographs of the wound were taken at each visit for the blinded evaluation.
Danish: Der blev taget fotos af såret ved hvert besøg til brug ved den blindede vurdering.
English: Repeated dose toxicity and local tolerance have been studied for up to 4 weeks.
Danish: Toksicitet ved gentagen dosering og lokal tolerance er undersøgt i indtil 4 uger.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Episalvan in one or more subsets of the paediatric population for the treatment of skin injuries.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Episalvan i en eller flere undergrupper af den pædiatriske population til behandling af hudskader.
English: Table 1: Adverse reactions reported in clinical trials System organ class
Danish: Tabel 1: Bivirkninger rapporteret i de kliniske forsøg Systemorganklasse
English: Table 2: Overview of Efficacy Results: Intra-patient difference in time to wound closure
Danish: Tabel 2: Oversigt over resultater vedrørende virkning: Intra-patient forskel i tid til lukning af såret
English: Since no biologically relevant levels of betulin were found in patients, no further studies related to distribution, biotransformation and elimination were performed.
Danish: Da der ikke fandtes relevante koncentrationer af betulin hos patienterne, blev der ikke udført yderligere forsøg vedrørende fordeling, biotransformation og elimination.
English: The safety and efficacy of Episalvan in children and adolescents under 18 years have not yet been established.
Danish: Episalvans sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: < PC: {number} SN: {number} NN: {number}>
Danish: SN: {nummer}
English: Episalvan should be used until the wound is healed or up to 4 weeks.
Danish: Episalvan skal anvendes, indtil såret er helet, eller i op til fire uger.
English: If you have an infection in the wound additional treatment may be required.
Danish: Hvis du får betændelse i såret, kan det være nødvendigt med supplerende behandling.
English: Treatment of partial thickness wounds in adults.
Danish: Behandling af delhudssår hos voksne.
English: Pregnancy No studies in pregnant women have been conducted.
Danish: Graviditet Der er ikke udført undersøgelser hos gravide.
English: In the following table, adverse reactions are listed by MedDRA system organ class and preferred term.
Danish: I nedenstående tabel er bivirkningerne opstillet efter MedDRA systemorganklasse og foretrukken betegnelse.
English: The single-use tube is packed in a cardboard box.
Danish: Engangstuben er pakket i en karton.
English: Difference in time to wound closure was set to 0 for photo series rated as ‘not evaluable'.
Danish: Forskellen i tid til lukning af et sår blev sat til 0 for serien af fotos bedømt som "ikke-evaluerbare".
English: Possible signs of a wound infection are that the wound begins to drain yellow or greenish fluid (pus), or that the skin around the wound becomes red, warm, swollen, or increasingly painful.
Danish: Mulige tegn på betændelse i såret er, at det begynder at afgive gul eller grønlig væske (pus), eller at huden omkring såret bliver rød, varm, hævet eller gør mere ondt.
English: The most frequently observed adverse reactions were wound complication (in 2.9% of patients), pain of skin (2.5%) and pruritus (1.3%).
Danish: De hyppigst iagttagne bivirkninger var sårkomplikationer (hos 2,9 % af patienterne), smerter i huden (2,5 %) og pruritus (1,3 %).
English: Interactions with topical products have not been investigated in clinical trials.
Danish: Interaktion med topikale produkter er ikke undersøgt i de kliniske studier.
English: Median time to wound healing was 7.3 days.
Danish: Mediantiden til heling af såret var 7,3 dage.
English: See section 4.2 for information on paediatric use.
Danish: 4.2 mht. oplysninger om pædiatrisk anvendelse.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, local tolerance, and phototoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, lokal tolerance og fototoksicitet.
English: In consequence a substantial number of photographs were excluded and not presented in the primary blinded read because of apparent gel residues.
Danish: I konsekvens heraf blev et betydeligt antal fotos ikke forelagt til primær blindet beskrivelse pga. synlige rester af gel.
English: Apply Episalvan at the next planned change of the wound dressing, continuing with your normal routine.
Danish: Påfør Episalvan ved næste planlagte skift af forbinding, og fortsæt som du plejer.
English: Carcinogenicity and reproductive and developmental toxicity studies have not been performed.
Danish: Der er ikke udført undersøgelser af karcinogenicitet, reproduktions- eller udviklingstoksicitet.
English: The secondary blinded read was conducted with all photographs presented to the blinded observers.
Danish: Ved den sekundære blindede beskrivelse blev alle fotos forelagt de blindede observatører.
English: Episalvan is safe to use for people who are allergic to birch pollen, as these allergens are not present in Episalvan.
Danish: Episalvan er sikkert at anvende for personer, der er allergiske for birkepollen, da disse allergener ikke findes i Episalvan.
English: CI: 95% confidence interval; MTWDC: mean time to wound dressing change; N: number of patients in the analysis set; STSG Split-thickness skin graft
Danish: SI: 95 % sikkerhedsinterval; MTWDC: Gennemsnitlig tid til skift af forbinding; N: Antal patienter i analysesæt; STSG: Delhudstransplantat
English: Once opened, the product should be used immediately and be discarded after use.
Danish: Efter åbning af emballagen skal produktet anvendes straks og kasseres efter brug.
English: ‘Less conservative calculation' differs from the ‘very conservative calculation' in one aspect: If wound closure was not observed in a wound half photo series, it was calculated to have occurred not one day, but approximately 3 days later (the mean time interval between wound dressing changes in the studies).
Danish: "Mindre forsigtig beregning" afviger fra "meget forsigtig beregning" i én henseende: Hvis der ikke blev iagttaget lukning af et sår i en serie fotos af sårhalvdele, blev dette fastlagt at have fundet sted ikke ét døgn, men ca. tre døgn senere (det gennemsnitlige tidsrum mellem skift af forbinding i forsøgene).
English: Warnings and precautions Talk to your doctor or nurse before using Episalvan.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før du bruger Episalvan.
English: Discard the tube after first use.
Danish: Kassér tuben efter første gangs brug.
English: In addition, there is one case report of contact dermatitis reported from a literature in a patient after prolonged use of a topical birch bark extract containing cosmetic product.
Danish: Derudover er der i litteraturen én case-rapport om kontaktdermatitis hos en patient efter langvarig anvendelse af et topikalt kosmetisk produkt indeholdende birkebarkekstrakt.
English: Episalvan is for single use only.
Danish: Episalvan er kun til engangsbrug.
English: See section 4.4 with respect to wound size and duration of treatment.
Danish: 4.4 vedrørende sårets størrelse og behandlingens varighed.
English: INFORMATION IN BRAILLE Episalvan gel (carton only)
Danish: INFORMATION I BRAILLESKRIFT Episalvan gel (kun karton)
English: No studies have been performed to establish whether Episalvan will interact with other medicines.
Danish: Der er ikke udført undersøgelser til fastlæggelse af, om Episalvan vil interagere med andre lægemidler.
English: Mechanism of action and pharmacodynamic effects The active substance accelerated re-epithelialization in an in vitro wound scratch assay using human primary keratinocytes at the dosage of 1 μg/ml, and in a porcine ex vivo wound healing model at the dosage of 10 µg/ml.
Danish: Virkningsmekanisme og farmakodynamiske virkninger Det aktive stof fremskyndede reepitelialiseringen ved et in vitro-sårskrabeassay, hvor der blev anvendt humane primære keratinocytter ved en dosering på 1 μg/ml, samt i en porcin ex vivo-sårhelingsmodel (studier med svin) med doseringen 10 µg/ml.
English: Fertility studies have not been conducted.
Danish: Der er ikke udført fertilitetsundersøgelser.
English: Based on data from three clinical studies with a total of 280 patients, application of Episalvan gel to open wounds did not lead to betulin plasma levels higher than natural background-levels originating e.g. from nutritional sources.
Danish: På grundlag af data fra tre kliniske studier med i alt 280 patienter medførte påføring af Episalvan gel på åbne sår ikke højere plasmakoncentration af betulin end det naturlige baggrundsniveau fra f.eks. ernæringen.
English: Wounds that are assessed as unable to heal within an acceptable time frame may need surgical measures (e.g., split-thickness skin grafting) to reduce the risk of hypertrophic scarring.
Danish: Sår, der ikke anses for at kunne hele inden for et acceptabelt tidsrum, kan kræve kirurgisk indgriben (f.eks. delhudstransplantat) for at mindske risikoen for hypertrofisk ardannelse.
English: Median time to wound healing was 14 days.
Danish: Mediantiden til heling af såret var 14 dage.
English: Of the patients with a between-treatment difference in wound healing (N=35), the percentage of patients who showed earlier healing (primary endpoint) of their Episalvan treated wound half (85.7% [95% CI: 69.7%, 95.2%]) was higher than those who showed earlier healing of their standard of care control treated wound half (14.3% [95% CI: 4.8%, 30.3%]) (p < 0.0001, binomial test).
Danish: Af de patienter, der havde behandlingsrelaterede forskelle i sårheling (N= 35), var der en højere procentdel, der udviste tidligere heling (det primære endepunkt) af den sårhalvdel, der var behandlet med Episalvan, (85,7 %, 95 % SI: [69,7 %; 95,2 %]) end af dem, der udviste tidligere heling af den sårhalvdel, der var behandlet med standardbehandling (14,3 %, 95 % SI: [4,8 %; 30.3 %]) (p < 0,0001, binomialtest).
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 formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V*
English: Mean intra-patient difference in time to wound closure (95% epithelialisation)
Danish: Gennemsnitlig intra-patient forskel i tid til lukning af såret (95 % epitelialisering)
English: Do not apply other products to the skin wound area at the same time of applying Episalvan.
Danish: Påfør ikke andre produkter på sårområdet samtidig med Episalvan.
English: Three Phase III studies were conducted to assess the efficacy and safety of Episalvan in the treatment of partial thickness wounds of the skin: two studies which investigated split-thickness skin graft donor site wounds, which included a total of 219 patients (ITT: N=217), and one further study in 61 patients with Grade 2a burn wounds (ITT: N=57).
Danish: Der er udført tre fase-III undersøgelser til vurdering af Episalvans virkning og sikkerhed ved behandling af delhudssår: to forsøg, hvor man undersøgte sår på donorstedet for delhudstransplantater, og hvori der indgik i alt 219 patienter (ITT: N=217), og desuden en hovedundersøgelse hos 61 patienter med brandsår af grad 2a (ITT: N=57).
English: If wound closure was not observed in a wound half photo series, it was calculated to have occurred one day after the last photograph in the series.
Danish: Hvis der ikke iagttoges lukning af et sår i en serie fotos af sårhalvdele, blev dette fastlagt at have fundet sted et døgn efter sidste foto i serien.
English: • Once the single-use tube has been opened, use the gel immediately and discard the tube, even if there's some left.
Danish: • Når engangstuben er åbnet, skal gelen bruges straks og tuben kasseres, selv om der er noget tilbage i den.
English: 'Very conservative calculation' means that the first observation of wound closure was taken as time of wound closure.
Danish: Ved "meget forsigtig beregning" forstås, at den første iagttagelse af lukning af et sår fandt sted på tidspunktet for lukning af såret.
English: DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Detaljeret information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Episalvan has no influence on the ability to drive and use machines.
Danish: Episalvan påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: • Re-apply the gel each time the dressing is changed, until the wound is healed.
Danish: • Påføringen af gelen gentages hver gang forbindingen skiftes, indtil såret er helet.
English: No data are available on possible interaction between Episalvan and other medicines applied to the skin.
Danish: Der foreligger ingen oplysninger om eventuel interaktion mellem Episalvan og andre lægemidler til påføring på huden.
English: 75223 Niefern-Öschelbronn Germany tel +49 (0) 7233 9749 - 0 fax +49 (0) 7233 9749 - 210 Email: info.de@amrytpharma.com
Danish: 75223 Niefern-Öschelbronn Tyskland tlf. +49 (0) 7233 9749 - 0 fax +49 (0) 7233 9749 - 210 E-mail: info.de@amrytpharma.com
English: In follow-up visits at 3 months and 12 months after the day of surgery or of burn injury the treated wound halves were found to be equal in the majority of patients with regard to pigmentation, redness, texture and hair growth of the regenerated epidermis.
Danish: Ved de opfølgende besøg 3 måneder og 12 måneder efter operationsdagen eller efter forbrændingen fandtes de behandlede sårhalvdele at svare til hinanden hos størstedelen af patienterne hvad angår pigmentering, rødme, og hårvækst af den regenererede epidermis.
English: Duration of use
Danish: Anvendelsens varighed