FrancophonIA/ELRC3.0 huggingface dataset:
English: Duration of use There is no information available on clinical use of Episalvan for more than 4 weeks.
Danish: Anvendelsens varighed Der findes ingen oplysninger om klinisk anvendelse af Episalvan i længere end 4 uger.
English: It is used in adults for the treatment of skin wounds, resulting for example from grade 2a burn wounds or from surgical skin graft transplantation.
Danish: Det anvendes hos voksne til behandling af sår, f.eks. brandsår af grad 2a eller sår fra hudtransplantationer.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA <PC: {nummer}
English: There is no experience from long-term use of Episalvan for more than 4 weeks.
Danish: Der er ingen erfaringer med langtidsbrug af Episalvan ud over 4 uger.
English: Wound complication adverse reactions such as wound infection and wound necrosis are complications of healing of partial thickness skin wounds and can be serious.
Danish: Sårkomplikationer såsom sårinfektion og sårnekrose er komplikationer til heling af delhudssår og kan være alvorlige.
English: Episalvan gel is administered topically to skin wounds and shows poor absorbtion.
Danish: Episalvan gel administreres topikalt på sår og udviser ringe absorption.
English: Overdosing with Episalvan is unlikely: in patients in which wound sizes >300 cm were repeatedly treated with Episalvan, no betulin plasma levels could be detected.
Danish: Overdosering med Episalvan er usandsynlig: Ved gentagne behandlinger af patienter med sårstørrelse >300 cm2 kunne der ikke påvises betulin i plasma.
English: Since the systemic exposure of Episalvan following cutaneous application is negligible no interaction with systemic treatments is expected.
Danish: Da den systemiske eksponering fra Episalvan efter kutan påføring er ubetydelig, forventes ingen interaktion med systemisk behandling.
English: Sunflower oil, refined.
Danish: Solsikkeolie, renset.
English: What you need to know before you use Episalvan 3.
Danish: Det skal du vide, før du begynder at bruge Episalvan 3.
English: Rash pruritic Purpura
Danish: Kløende udslæt Purpura
English: Do not use this medicine after the expiry date which is stated on the carton and tube after ‘EXP'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på kartonen og blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The precise mechanism of action of the active substance in wound healing in humans is not known.
Danish: Det aktive stofs nøjagtige virkningsmekanisme ved sårheling hos mennesker kendes ikke.
English: Episalvan gel is a herbal medicinal product which contains dry extract from birch bark.
Danish: Episalvan gel er et plantelægemiddel, der indeholder tørret ekstrakt af birkebark.
English: Toxicity studies of longer duration than 4 weeks have not been performed.
Danish: Der er ikke udført toksicitetsundersøgelser af længere varighed end fire uger.
English: If your wound shows no signs of improvement over time, talk to your doctor or nurse.
Danish: Viser såret ikke tegn på bedring efter et stykke tid, skal du sige det til lægen eller sundhedspersonalet.
English: ‘Primary' vs. ‘secondary' blinded read: In the primary blinded read evaluation a rigorous quality check was implemented to assure blinding of the observers.
Danish: "Primær" kontra "sekundær" blindet beskrivelse: Ved den primære blindede beskrivelse blev blinding af iagttagerne sikret ved streng kvalitetskontrol.
English: The target wound area of each patient was divided into two treatment areas of approximately the same size; the treatment allocation to the two halves of the wound (distal vs. proximal) was determined by randomization (in the burn trial, two similar wounds could be used).
Danish: Sårarealet for hver patient bliver opdelt i to behandlingsområder, som har omtrent samme størrelse; behandlingens allokering til de to halvdele af såret (distalt eller proksimalt) blev fastlagt ved randomisering (i undersøgelsen af brandsår kunne 2 ”ens” sår anvendes).
English: Wound halves treated with Episalvan healed faster than the wound halves treated with standard of care (mean 1.1 days according to primary endpoints, p<0.0001, two-sided paired t-test).
Danish: De sårhalvdele, der blev behandlet med Episalvan, helede hurtigere end de sårhalvdele, der blev behandlet med standardbehandling (i gennemsnit 1,1 døgn i henhold til primære endepunkter (p <0,0001, tosidet parret t-test).
English: If you forget to use Episalvan
Danish: Hvis du har glemt at bruge Episalvan
English: Episalvan gel is packed in white collapsible aluminium tubes.
Danish: Episalvan gel er emballeret i hvide sammenpresselige aluminiumstuber.
English: See section 4.4 and 5.1 with respect to type of wounds studied.
Danish: 4.4 og 5.1 vedrørende sårtyper omfattet af forsøgene.
English: Observer-blinded photo assessment (blinded read), mean expert evaluation primary blinded read / very conservative calculation (primary endpoint for STSG studies)
Danish: Observatørblindet beskrivelse af fotos (blindet beskrivelse), gennemsnit af ekspertbeskrivelse Primær blindet beskrivelse / meget forsigtig beregning (primære endepunkt for delhudstransplantat-forsøgene)
English: No formal studies have been conducted with Episalvan in patients with renal or hepatic impairment.
Danish: Der er ikke udført formelle studier med Episalvan hos patienter med nedsat nyre- eller leverfunktion.
English: For a subset of patients blinded photo-evaluation indicated better results for Episalvan treated wound halves compared to standard of care in pigmentation, redness and texture of the former wound areas.
Danish: For en undergruppe af patienter viste den blindede beskrivelse af fotos bedre resultater for de sårhalvdele, der var behandlet med Episalvan, end med standardbehandling, hvad angår pigmentering, rødme og struktur af de tidligere sårområder.
English: No effects on human fertility are anticipated, since the systemic exposure is negligible.
Danish: Der forventes ingen virkning på den humane fertilitet, da den systemiske eksponering er ubetydelig.
English: Pack size: 1 single-use tube containing 23.4 g gel.
Danish: Pakningsstørrelse: 1 engangstube indeholdende 23,4 g gel.
English: Wound complication* * Wound complication comprises different kinds of local complications such as post-procedural complications, wound necrosis, wound secretion, impaired healing, or inflammation of wound.
Danish: * Sårkomplikationer omfatter forskellige former for lokale komplikationer såsom komplikationer efter indgreb, sårnekrose, væskeafgivelse fra såret, mangelfuld heling eller inflammation af såret.
English: Wound size
Danish: Sårets størrelse
English: Pack size:1 tube of 23.4 g gel.
Danish: Pakningsstørrelse: 1 tube med 23,4 g gel.
English: NAME OF THE MEDICINAL PRODUCT Episalvan gel
Danish: LÆGEMIDLETS NAVN Episalvan gel
English: Wound infection is a serious complication that can occur during the healing process.
Danish: Betændelse i et sår er en alvorlig komplikation, der kan forekomme under helingen.
English: This product is for single use only and once opened, the product should be used immediately.
Danish: Dette lægemiddel er kun til engangsbrug og skal bruges straks efter at emballagen er åbnet.
English: Fresh wounds should achieve haemostasis prior to application of Episalvan.
Danish: Friske sår skal opnå hæmostase før påføring af Episalvan.
English: -1.1 days (CI: -1.5, -0.7) faster wound closure with Episalvan, p<0.0001a
Danish: -1,1 døgn (SI: [-1.5; -0.7]) hurtigere lukning af sår med Episalvan, p <0,0001a
English: In the case of infection, it is recommended to discontinue treatment with Episalvan.
Danish: Ved infektion anbefales det at seponere Episalvan.
English: In the Grade 2a burn wound study an octenidine containing antiseptic wound gel and fatty gauze dressing were used as control.
Danish: I forsøget med brandsår af grad 2a anvendtes en antiseptisk octenidingel og en fedtholdig gazeforbinding som kontrol.
English: 75223 Niefern-Öschelbronn Germany tel +49 (0) 7233 9749 - 0 fax+49 (0) 7233 9749 - 210
Danish: Tyskland tlf. +49 (0) 7233 9749 - 0 fax +49 (0) 7233 9749 - 210
English: Repeated critical assessment of burn depth and healing progression is needed.
Danish: Forbrændingens dybde og helingens forløb kræver gentagen kritisk vurdering.
English: However, since the amount of Episalvan absorbed into the body is extremely low it is not expected that Episalvan will interact with other medicines.
Danish: Da det kun er en yderst ringe mængde af Episalvan, der optages i kroppen, forventes Episalvan ikke at interagere med andre lægemidler.
English: Extraction solvent: n-Heptane
Danish: Første ekstraktionsmiddel: n-heptan
English: Discard after use.
Danish: Kasseres efter brug.
English: The primary endpoint for the Grade 2a burn wound trial was the percentage of patients with earlier healing (at least 95% epithelialisation) based on blinded photo evaluations.
Danish: Det primære endepunkt for forsøget med brandsår af grad 2a var den procentdel af patienterne, der fik tidligere heling (mindst 95 % epitelialisering) på basis af den blindede beskrivelse af fotos.
English: In the Grade 2a burn wound study, the mean wound size treated with Episalvan was 108 cm² (range 23-395 cm²).
Danish: I forsøget med brandsår af grad 2a havde sår behandlet med Episalvan en gennemsnitlig størrelse på 108 cm² (variationsbredde 23-395 cm²).
English: The primary endpoint for the two split-thickness skin graft trials was the intra-individual difference in time to wound closure (at least 95% epithelialisation) based on blinded photo evaluations.
Danish: Det primære endepunkt for de to forsøg med delhudstransplantat var den intraindividuelle forskel i tiden til lukning af såret (mindst 95 % epitelialisering) baseret på blindet beskrivelse af fotos.
English: The effect of Episalvan on fertility has not been studied, but since the absorption of this medicine into the body is extremely low, it is not expected to have an effect on your fertility.
Danish: Virkningen af Episalvan på frugtbarheden er ikke undersøgt, men da optagelsen af dette lægemiddel i kroppen er meget lav, forventes det ikke at have nogen virkning på frugtbarheden.
English: No data have been generated to study the effect of accidental ingestion of Episalvan.
Danish: Der er ikke indsamlet data til undersøgelse af virkningen af utilsigtet indtagelse af Episalvan.
English: LIST OF EXCIPIENTS Excipient: Sunflower oil.
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestof: Solsikkeolie.
English: Application was at each wound dressing change every third to fourth day until full wound closure up to 28 days for the splitthickness skin graft trials, and every other day up to 21 days for the Grade 2a burn trial.
Danish: I forsøgene med delhudstransplantat fandt påføring sted ved hvert skift af forbinding hver 3.-4. dag indtil fuld lukning af såret i op til 28 dage, og i forsøget med brandsår af grad 2a hver anden dag i indtil 21 dage.
English: The mean wound size treated with Episalvan in clinical studies in split-thickness skin graft donor site wounds was 40.7 cm² (range 8-300 cm²).
Danish: Sår behandlet med Episalvan i de kliniske forsøg med sår på donorstedet for delhudstransplantater var i gennemsnit 40,7 cm² (variationsbredde 8-300 cm²).
English: It is not known whether Episalvan passes into human breast milk, but since the absorption of this medicine into the body is minimal, the risk to the baby is negligible.
Danish: Det vides ikke, om Episalvan går over i modermælken, men da optagelsen af dette lægemiddel i kroppen er minimal, er risikoen for barnet ubetydelig.
English: Always use this medicine exactly as your doctor or nurse has told you.
Danish: Brug altid dette lægemiddel medicin nøjagtigt efter lægens eller sundhedspersonalets anvisning.
English: The gel should be re-applied at each wound dressing change, until the wound is healed, for up to 4 weeks.
Danish: Gelen påføres igen ved hvert skift af forbinding indtil såret er helet, i indtil 4 uger.
English: • If necessary, wounds should be cleansed using a suitable antiseptic solution prior to application of Episalvan
Danish: • Administration (påføring)Om nødvendigt renses såret med en passende antiseptisk opløsning før påføring af Episalvan.
English: There is no clinical experience from use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers, venous leg ulcers or wounds in patients with epidermolysis bullosa.
Danish: Der er ingen klinisk erfaring med brug af Episalvan til behandling af kroniske sår, f.eks. diabetiske fodsår, venøse bensår ellers sår ved epidermolysis bullosa.
English: Hypersensitivity to the active substance or to the excipient listed in section 6.1.
Danish: Overfølsomhed for det aktive stof eller for hjælpestoffet anført i pkt.
English: No effects during pregnancy are anticipated, since systemic exposure to Episalvan is negligible.
Danish: Der forventes ingen virkning under graviditet, da den systemiske eksponering for Episalvan er ubetydelig.
English: Episalvan can be used during breast-feeding, unless the chest area is subject to treatment.
Danish: Episalvan kan anvendes under amning, medmindre brystkasseområdet er omfattet af behandlingen.
English: If necessary, wounds (accidental wounds) should be cleaned according to standard procedure, using e.g. wound antiseptic solution, prior to application of Episalvan.
Danish: Om nødvendigt skal sårene (accidentelle sår) renses på sædvanlig måde, f.eks. med antiseptisk opløsning, før Episalvan påføres.
English: Breast-feeding No data are available to evaluate whether Episalvan is excreted into human milk.
Danish: Amning Der foreligger ingen data til vurdering af, om Episalvan udskilles i brystmælk.
English: Episalvan should be used as advised by your doctor or nurse.
Danish: Hvis du holder op med at bruge Episalvan Episalvan skal bruges som anvist af lægen eller sygeplejersken.
English: No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment, see section 5.2.
Danish: Der forventes ingen dosisjustering eller særlig hensyntagen til patienter med nedsat nyre- eller leverfunktion, se pkt.
English: Uncommon side effects (may affect up to 1 in 100 people): - wound infection - allergic reaction (hypersensitivity) - skin irritation (dermatitis) - itchy rash - purple coloured rash - pain
Danish: Ikke almindelige bivirkninger (forekommer hos indtil 1 ud af 100 personer): - betændelse i såret - overfølsomhed (allergisk reaktion) - hudirritation (dermatitis) - kløende udslæt - blårødt udslæt - smerter
English: In the burn wound study with 61 patients, the mean study wound area was 216 cm2; the total burn injury of these patients was larger and affected 5.8% of the total body surface area.
Danish: I forsøget med år, og størrelsen af såret på donorstedet var i gennemsnit 81,5 cm brandsår med 61 patienter var sårarealet i gennemsnit 216 cm2; det samlede forbrændte areal hos disse patienter var større og svarede til 5,8 % af hele legemsoverfladen.
English: There is insufficient experience of the use of Episalvan in children and adolescents under 18 years of age, therefore it should not be used in these patients.
Danish: Der er ikke tilstrækkelige erfaringer med brug af Episalvan hos børn og unge under 18 år.
English: • Episalvan should be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile wound dressing.
Danish: • Episalvan påføres såroverfladen i et ca. 1 mm tykt lag og dækkes med en steril forbinding.
English: There is no experience of the use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers or venous leg ulcers.
Danish: Der er ingen erfaring med brug af Episalvan til behandling af kroniske sår, f.eks. diabetiske fodsår eller venøse bensår.
English: No studies have been done on the effects of Episalvan on pregnant women, but since the absorption of this medicine into the body is extremely low, the risk to the unborn baby is negligible.
Danish: Der er ikke udført undersøgelser af virkningerne af Episalvan på gravide kvinder, men da lægemidlets optagelse i kroppen er yderst lav, er risikoen for det ufødte barn ubetydelig.
English: Episalvan can be used during breast-feeding, unless the chest area is being treated.
Danish: Episalvan kan anvendes under amning, medmindre brystkasseområdet er under behandling.
English: <2D barcode carrying the unique identifier included.>
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
English: If you use more Episalvan than you should Episalvan is applied to the skin and the absorption into the body is minimal.
Danish: Episalvan påføres på huden, og optagelsen i kroppen er minimal.
English: The tubes are closed with a tamper-evident aluminium membrane and fitted with a white polypropylene screw cap.
Danish: Tuben er lukket med aluminiumforsegling og har hvidt skruelåg af polypropylen.
English: Episalvan gel Birch bark extract
Danish: Episalvan gel Birkebark-ekstrakt
English: Check with your doctor or nurse if you are not sure.
Danish: Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: 75223 Niefern-Öschelbronn Germany
Danish: 75223 Niefern-Öschelbronn Tyskland
English: The most frequently reported side effects are: Common side effects (may affect up to 1 in 10 people): - painful skin - itching - complications in the wound healing process
Danish: Almindelige bivirkninger (forekommer hos indtil 1 ud af 10 personer): - smerter i huden - kløe - komplikationer ved sårhelingen
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1g gel contains: 100 mg extract (as dry extract, refined) from birch bark from Betula pendula Roth, Betula pubescens Ehrh.
Danish: 1 g gel indeholder 100 mg ekstrakt (som tørekstrakt, raffineret) af Betula pendula Roth., Betula pubescens Ehrh.
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: Du kan også indberette bivirkninger via det nationale rapporteringssystem anført i Appendiks V*
English: What you need to know before you use Episalvan
Danish: Det skal du vide, før du begynder at bruge Episalvan
English: Birch pollen allergy
Danish: Allergi over for birkepollen
English: 75223 Niefern-Öschelbronn GERMANY
Danish: 75223 Niefern-Öschelbronn
English: Other wound types
Danish: Andre sårtyper
English: The gel should be applied to the wound surface at a thickness of approximately 1 mm and covered by sterile wound dressing.
Danish: Gelen påføres såroverfladen i en tykkelse på ca. 1 mm og dækkes med en steril forbinding.
English: Colourless to slightly yellowish, opalescent.
Danish: Farveløs til let gullig, mælkeagtig.
English: Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Episalvan Fortæl det altid til lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har brugt det for nylig.
English: How to store Episalvan 6.
Danish: Sådan skal du bruge Episalvan 4.
English: Episalvan plus wound dressing was applied to half of the wound area, and the same kind of non-adhesive wound dressing alone was applied to the other half as the control in the split-thickness skin graft donor site studies.
Danish: I forsøgene med delhudstransplantater på donorstedet blev Episalvan plus forbinding påført på halvdelen af sårets overflade, og samme type ikke-klæbende forbinding blev påført som kontrol på den anden halvdel.
English: as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), corresponding to 72-88 mg betulin.
Danish: eller hybrider heraf, cortex (birkebark) svarende til 0,5-1 g birkebark, svarende til 72-88 mg betulin.
English: Grade 2a burn wound study
Danish: Forsøget med brandsår af grad 2a
English: How to use Episalvan
Danish: Sådan skal du bruge Episalvan
English: - If you get any side effects, talk to your doctor or nurse.
Danish: - Hvis du får bivirkninger, skal du sige det til lægen eller sundhedspersonalet.
English: If you get any side effects, talk to your doctor or nurse.
Danish: Hvis du får bivirkninger, skal du sige det til lægen eller sundhedspersonalet.
English: 1 g gel contains: 100 mg extract (as dry extract, refined) from birch bark from Betula pendula, Betula pubescens as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), corresponding to 72-88 mg betulin.
Danish: 1 g gel indeholder: 100 mg birkebark-ekstrakt (som tør ekstrakt, raffineret), fra Betula pendula/Betula pubescens, svarende til 0,5-1 g birkebark, svarende til 72-88 mg betulin.
English: However, wound infection is an important and serious complication that can occur during wound healing.
Danish: Sårinfektion kan imidlertid forekomme under heling af såret som en vigtig og alvorlig komplikation.
English: - If you have any further questions, ask your doctor or nurse.
Danish: Er du i tvivl, så spørg lægen eller sundhedspersonalet.
English: What Episalvan looks like and contents of the pack Episalvan is a colourless to slightly yellowish, opalescent gel.
Danish: Episalvan er en klar til let gullig, mælkeagtig gel.
English: The 219 patients with split-thickness skin graft donor site wounds had a mean age of 53 years; their donor site mean wound size was 81.5 cm2.
Danish: De 219 patienter med sår på donorstedet for delhudstransplantater var i gennemsnit 53
English: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Episalvan is negligible.
Danish: Der forventes ingen påvirkning af nyfødte/spædbørn, som ammes af mødre i behandling med Episalvan, da den systemiske eksponering er ubetydelig.
English: For cutaneous application.
Danish: Til kutan påføring.
English: -1.0 days (CI: -1.4, -0.6) faster wound closure with Episalvan, p<0.0001a
Danish: -1,0 døgn (SI: [-1.4;0.6]) hurtigere lukning af sår med Episalvan, p <0,0001a a Baseret på 2-sidet parret t-test
English: White collapsible aluminium tube, interior lacquered with epoxy phenolic coating, and with a sealing compound in the fold.
Danish: 6.5 Emballagetype og pakningsstørrelser Hvid sammenpresselig aluminiumtube med indvendig epoxyfenolbelægning og tætningsmasse i falsen.
English: Episalvan does not contain birch pollen, so it may be used by people with birch pollen allergy.
Danish: Det kan bruges af personer med birkepollenallergi.
English: If you stop using Episalvan
Danish: Hvis du har brugt for meget Episalvan
English: Partial thickness burn wounds
Danish: Smerter i huden Dermatitis Puritus
English: Pruritus
Danish: Dosering
English: Extraction solvent: n-heptane.
Danish: Ekstraktionsmiddel: n-heptan 95% w/w.
English: Driving and using machines Your ability to drive and use machines will not be affected by this medicine.
Danish: Trafik- og arbejdssikkerhed Episalvan påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: What Episalvan is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: Contents of the pack and other information What Episalvan contains The active substance is a dry extract from birch bark.
Danish: Det aktive stof er tørret ekstrakt af birkebark.
English: This summary was last updated in September 2011.
Danish: Dette sammendrag blev sidst ajourført i 09-2011.
English: The vaccine is given just behind the ear.
Danish: Vaccinen gives lige bag øret.
English: If someone is accidentally injected with this product, they should seek immediate medical advice immediately.
Danish: Hvis en person ved et uheld injiceres med dette produkt, skal vedkommende omgående søge lægehjælp.
English: The Package Leaflet should be taken to the doctor.
Danish: Indlægssedlen skal tages med til lægen.
English: The vaccine was generally well tolerated and shown to be safe.
Danish: Vaccinen tåltes overvejende godt, og lægemidlets sikkerhed blev påvist.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Danish: Benefit/riskforholdet fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: This bacterium is often present with Pasteurella multocida and makes the disease worse.
Danish: Denne bakterie optræder ofte sammen med Pasteurella multocida og forværrer sygdommen.