FrancophonIA/ELRC3.0 huggingface dataset:
English: The Phase III studies were blindly evaluated, prospective, intra-individually controlled, randomised, multicentre trials.
Estonian: III faasi uuringud olid pimemeetodil hinnatud, prospektiivsed, isikusiseselt kontrollitud, randomiseeritud ja mitmekeskuselised uuringud.
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).
Estonian: Ärge kasutage Episalvani - kui olete kasetohu või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
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.
Estonian: Episalvani kasutamise kohta alla 18-aastastel lastel ja noorukitel ei ole piisavalt kogemusi, seetõttu ei tohi seda neil patsientidel kasutada.
English: Other topical products should not be concomitantly used together with Episalvan but rather sequentially or alternatively depending on the clinical need.
Estonian: Muid paikseid ravimeid ei tohi kasutada samal ajal koos Episalvaniga, vaid sõltuvalt kliinilisest vajadusest pigem järjestikku või alternatiivselt.
English: If you have an infection in the wound additional treatment may be required.
Estonian: Kui teil on haavainfektsioon, võib olla vajalik täiendav ravi.
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).
Estonian: Kõrvaltoimete esinemissagedused on määratletud järgmiselt: väga sage (≥ 1/10), sage (≥ 1/100 kuni < 1/10), aeg-ajalt (≥ 1/1000 kuni < 1/100), harv (≥ 1/10 000 kuni < 1/1000), väga harv (< 1/10 000), teadmata (ei saa hinnata olemasolevate andmete alusel).
English: Median time to wound healing was 14 days.
Estonian: Mediaanaeg haava paranemiseni oli 14 päeva.
English: In the case of infection, it is recommended to discontinue treatment with Episalvan.
Estonian: Infektsiooni korral soovitatakse ravi Episalvaniga katkestada.
English: 'Very conservative calculation' means that the first observation of wound closure was taken as time of wound closure.
Estonian: Väga konservatiivne arvutus tähendab, et esmakordset haava sulgumise vaatlust käsitleti haava sulgumise ajana.
English: Fertility studies have not been conducted.
Estonian: Fertiilsusuuringuid ei ole läbi viidud.
English: OUTER CARTON and TUBE
Estonian: VÄLISKARP ja TUUB
English: • Once the single-use tube has been opened, use the gel immediately and discard the tube, even if there's some left.
Estonian: • Pärast seda, kui ühekordselt kasutatav tuub on avatud, kasutage geeli kohe ja visake tuub minema, isegi kui osa geeli jääb alles.
English: Episalvan has no influence on the ability to drive and use machines.
Estonian: Episalvan ei mõjuta autojuhtimise ja masinate käsitsemise võimet.
English: Treatment of partial thickness wounds in adults.
Estonian: Pindmiste haavade ravi täiskasvanutel.
English: Patients with deeper burn wounds (Grade 2b) were not included.
Estonian: Uuringusse ei kaasatud sügavamate põletushaavadega (2b aste) patsiente.
English: Episalvan is for single use only.
Estonian: Episalvan on ette nähtud ainult ühekordseks kasutamiseks.
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
Estonian: Usaldusvahemik: 95% usaldusintervall; MTWDC: keskmine aeg haavasideme vahetamiseni; N: patsientide arv analüüsikomplektis; STSG: osaline nahasiirik
English: Since no biologically relevant levels of betulin were found in patients, no further studies related to distribution, biotransformation and elimination were performed.
Estonian: Et patsientidel ei avastatud bioloogiliselt olulisi betuliini kontsentratsioone, ei sooritatud edasisi jaotumise, biotransformatsiooni ega eritumise uuringuid.
English: The most frequently observed adverse reactions were wound complication (in 2.9% of patients), pain of skin (2.5%) and pruritus (1.3%).
Estonian: Kõige sagedamini täheldatud kõrvaltoimed olid haavatüsistused (2,9% patsientidest), nahavalu (2,5%) ja sügelus (1,3%).
English: Pregnancy No studies in pregnant women have been conducted.
Estonian: Rasedus Rasedatel ei ole uuringuid läbi viidud.
English: The active substance was not genotoxic in in vitro assays.
Estonian: Toimeaine ei olnud in vitro analüüsides genotoksiline.
English: There is no experience from long-term use of Episalvan for more than 4 weeks.
Estonian: Puudub kogemus Episalvani pikaajalise kasutamise kohta üle 4 nädala.
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.
Estonian: Kui haavapoole fotoseerias ei täheldatud haava sulgumist, märgiti, et see toimus üks päev pärast seeria viimast fotot.
English: Toxicity studies of longer duration than 4 weeks have not been performed.
Estonian: Üle 4 nädala kestvaid toksilisuse uuringuid ei ole läbi viidud.
English: INFORMATION IN BRAILLE Episalvan gel (carton only)
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Episalvan geel (ainult karp)
English: Do not use this medicine after the expiry date which is stated on the carton and tube after ‘EXP'.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja tuubil pärast märget „Kõlblik kuni:”.
English: Grade 2a burn wound study
Estonian: 2a astme põletushaavade uuring
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).
Estonian: Patsientidest, kellel oli haava paranemises ravimeetodite vahel erinevus (N = 35), oli rohkem neid, kelle haavapool paranes varem (esmane tulemusnäitaja) Episalvani ravi korral (85,7%) [95% usaldusvahemik: 69,7%, 95,2%], samas kui standardse ravi korral paranes haavapool varem vähematel patsientidel (14,3%) [95% usaldusvahemik: 4,8%, 30,3%]) (p < 0,0001, binoomtest).
English: Discard the tube after first use.
Estonian: Visake tuub pärast esimest kasutamiskorda minema.
English: Episalvan is safe to use for people who are allergic to birch pollen, as these allergens are not present in Episalvan.
Estonian: Episalvani on ohutu kasutada inimestel, kes on allergilised kaseõietolmu vastu, sest neid allergeene Episalvanis ei leidu.
English: Do not apply other products to the skin wound area at the same time of applying Episalvan.
Estonian: Ärge kandke muid ravimeid nahahaava piirkonda samal ajal, kui te kasutate Episalvani.
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).
Estonian: Viidi läbi kolm III faasi uuringut Episalvani efektiivsuse ja ohutuse hindamiseks naha pindmiste haavade ravis: kahes uuringus uuriti osalise nahasiiriku doonori haavakohti ja nendes osales 219 patsienti (ITT: N = 217) ja ühes edasises uuringus 61 patsiendil uuriti 2a astme põletushaavu (ITT: N = 57).
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.
Estonian: Järelkontrolli visiitidel 3 kuud ja 12 kuud pärast operatsiooni või põletusvigastuse päeva leiti, et enamikul juhtudel olid ravitud haava pooled võrdsed, arvestades regenereerunud epidermise pigmentatsiooni, punetust, tekstuuri ja karvakasvu.
English: Episalvan can be used during breast-feeding, unless the chest area is being treated.
Estonian: Episalvani võib kasutada imetamise ajal, välja arvatud juhul, kui ravitakse rinnapiirkonda.
English: Duration of use There is no information available on clinical use of Episalvan for more than 4 weeks.
Estonian: Kasutamise kestus Puudub teave Episalvani kliinilise kasutamise kohta üle 4 nädala.
English: The other ingredient is refined sunflower oil.
Estonian: Teine koostisosa on rafineeritud päevalilleõli.
English: In the following table, adverse reactions are listed by MedDRA system organ class and preferred term.
Estonian: Järgmises tabelis on kõrvaltoimed loetletud MedDRA organsüsteemide ja eelisterminite alusel.
English: Episalvan does not contain birch pollen, so it may be used by people with birch pollen allergy.
Estonian: Episalvan ei sisalda kase õietolmu, seega võib seda kasutada inimestel, kellel on kase õietolmu vastu allergia.
English: Repeated dose toxicity and local tolerance have been studied for up to 4 weeks.
Estonian: Korduvtoksilisust ja paikset taluvust on uuritud kuni 4 nädala jooksul.
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.
Estonian: Episalvani üleannustamine ei ole tõenäoline: patsientidel, kellel haavu suurusega >300 cm2 raviti korduvalt Episalvaniga, ei tuvastatud betuliini sisaldust plasmas.
English: Apply Episalvan at the next planned change of the wound dressing, continuing with your normal routine.
Estonian: Manustage Episalvani järgmisel plaanitud haavasideme vahetamisel ja jätkake tavapärase manustamisega.
English: This product is for single use only and once opened, the product should be used immediately.
Estonian: See ravim on ainult ühekordseks kasutamiseks ja pärast avamist tuleb ravimit kohe kasutada.
English: What Episalvan is and what it is used for
Estonian: Mis ravim on Episalvan ja milleks seda kasutatakse
English: However, wound infection is an important and serious complication that can occur during wound healing.
Estonian: Siiski on haavainfektsioon oluline ja raske tüsistus, mis võib tekkida haava paranemise ajal.
English: If you use more Episalvan than you should Episalvan is applied to the skin and the absorption into the body is minimal.
Estonian: Kui te kasutate Episalvani rohkem kui ette nähtud Episalvan kantakse nahale ja selle imendumine organismi on minimaalne.
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.
Estonian: Seda kasutatakse täiskasvanutel nahahaavade raviks, mille põhjuseks on näiteks 2a astme põletused või kirurgiline nahasiirikute siirdamine.
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.
Estonian: Toimemehhanism ja farmakodünaamilised toimed Toimeaine kiirendas reepiteliseerumist in vitro kriimustushaava testis, kus kasutati inimese esmaseid keratinotsüüte annuses 1 μg/ml ja sigade ex vivo haava paranemise mudelis annuses 10 µg/ml.
English: Observer-blinded photo assessment (blinded read), mean expert evaluation primary blinded read / very conservative calculation (primary endpoint for STSG studies)
Estonian: Vaatlejapime fotode hindamine (pimelugemine), keskmine eksperdihinnang esmane pimelugemine / väga konservatiivne arvutus (esmane tulemusnäitaja osalise nahasiiriku uuringute jaoks)
English: In consequence a substantial number of photographs were excluded and not presented in the primary blinded read because of apparent gel residues.
Estonian: Selle tulemusena välistati oluline hulk fotosid ja nähtavate geelijääkide tõttu ei esitatud neid esmaseks pimelugemiseks.
English: The precise mechanism of action of the active substance in wound healing in humans is not known.
Estonian: Toimeaine täpne toimemehhanism inimese haava paranemisele ei ole teada.
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.
Estonian: TEKSTI LÄBIVAATAMISE KUUPÄEV Täpne teave selle ravimpreparaadi kohta on Euroopa Ravimiameti kodulehel: http://www.ema.europa.eu.
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.
Estonian: Haavad, mida hinnatakse lubatud aja jooksul paranemisvõimetuteks, võivad vajada hüpertroofilise armistumise riski vähendamiseks kirurgilisi meetmeid (nt osaline nahasiirik).
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Estonian: AINULAADNE IDENTIFIKAATOR - INIMLOETAVAD ANDMED <PC: {number}
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.
Estonian: Lisaks on kirjanduses teade ühest kontaktdermatiidi juhust, mis tekkis kasetohuekstrakti sisaldanud kosmeetilise toote pikaajalise paikse kasutamise järel.
English: What you need to know before you use Episalvan
Estonian: Mida on vaja teada enne Episalvani kasutamist
English: Table 2: Overview of Efficacy Results: Intra-patient difference in time to wound closure
Estonian: Efektiivsustulemuste ülevaade: Patsiendisisene haava sulgumise ajaline erinevus
English: Difference in time to wound closure was set to 0 for photo series rated as ‘not evaluable'.
Estonian: Erinevus ajas kuni haava sulgumiseni määrati 0-ks fotoseeriate puhul, mida peeti mittehinnatavateks.
English: The secondary blinded read was conducted with all photographs presented to the blinded observers.
Estonian: Teisene pimelugemine viidi läbi nii, et pimemenetluse vaatlejatele esitati kõik fotod.
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.
Estonian: Haavainfektsiooni näitab see, kui haav hakkab eritama kollast või rohekat vedelikku (mäda) või et haavaümbruse nahk muutub punaseks, soojaks, turseliseks või väga valusaks.
English: Wound infection
Estonian: Haavainfektsioon
English: Episalvan gel is packed in white collapsible aluminium tubes.
Estonian: Episalvani geel on pakitud valgetesse kokkusurutavatesse alumiiniumtuubidesse.
English: Once opened, the product should be used immediately and be discarded after use.
Estonian: Pärast avamist tuleb ravimit kohe kasutada ja pärast kasutamist minema visata.
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.
Estonian: Kokku 280 patsiendil läbi viidud kolme kliinilise uuringu andmetel ei põhjustanud Episalvani geeli manustamine lahtistele haavadele betuliini plasmakontsentratsioone, mis ületaksid nt toiduainetest pärinevat looduslikku fooni.
English: 75223 Niefern-Öschelbronn Germany
Estonian: 75223 Niefern-Öschelbronn Saksamaa
English: 75223 Niefern-Öschelbronn GERMANY
Estonian: 75223 Niefern-Öschelbronn SAKSAMAA
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).
Estonian: Iga patseiendi sihthaava piirkond jagati kaheks ligikaudu sama suurusega ravipiirkonnaks; haava kahe poole ravi (distaalne vs. proksimaalne) määrati randomiseerimise teel (põletuste uuringus võidi kasutada kaht sarnast haava).
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).
Estonian: Episalvaniga ravitud haava pooled paranesid kiiremini kui standardraviga ravitud haava pooled (esmase tulemusnäitaja osas keskmiselt 1,1 päeva, p < 0,0001, kahepoolne paaris t-test).
English: The single-use tube is packed in a cardboard box.
Estonian: Ühekordseks kasutamiseks ette nähtud tuub on pakendatud kartongkarpi.
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.
Estonian: Ravimit kanti haavale igal haavasideme vahetamise korral igal kolmandal või neljandal päeval kuni haava täieliku sulgumiseni kuni 28 päeva jooksul osalise nahasiiriku haavade uuringutes ja igal teisel päeval kuni 21 päeva jooksul 2a astme põletushaavade uuringus.
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.
Estonian: Põletushaavade uuringus 61 patsiendiga oli keskmine uuringuhaava suurus 216 cm2; nende patsientide kogu põletusvigastus oli suurem ja haaras 5,8% nahapinnast.
English: ‘Primary' vs. ‘secondary' blinded read: In the primary blinded read evaluation a rigorous quality check was implemented to assure blinding of the observers.
Estonian: Esmane vs. teisene pimelugemine: Esmasel pimelugemisel rakendati ranget kvaliteedikontrolli, et tagada vaatlejate pimemenetlus.
English: Table 1: Adverse reactions reported in clinical trials System organ class
Estonian: Kliinilistes uuringutes täheldatud kõrvaltoimed Organsüsteemi klass
English: Pack size: 1 single-use tube containing 23.4 g gel.
Estonian: Pakendi suurus: üks ühekordselt kasutatav tuub, mis sisaldab 23,4 g geeli.
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.
Estonian: Kuivõrd organismi imenduv Episalvani kogus on siiski väga väike, ei ole oodata, et Episalvanil esineks koostoimeid teiste ravimitega.
English: Intention-to-treat (ITT) data set.
Estonian: Ravikavatsuslik (ITT) andmekomplekt.
English: How to store Episalvan 6.
Estonian: Kuidas Episalvani säilitada 6.
English: • Episalvan should be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile wound dressing.
Estonian: • Episalvan tuleb kanda haava pinnale umbes 1 mm paksuselt ja katta steriilse haavasidemega.
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.
Estonian: Haavatüsistuste kõrvaltoimed, näiteks haavainfektsioon ja haavanekroos, on pindmiste nahahaavade paranemise tüsistused ning need võivad olla rasked.
English: -1.1 days (CI: -1.5, -0.7) faster wound closure with Episalvan, p<0.0001a
Estonian: -1,1 päeva (usaldusvahemik: -1,5,0,7) kiirem haava sulgumine Episalvaniga, p < 0,0001a
English: Photographs of the wound were taken at each visit for the blinded evaluation.
Estonian: Igal visiidil tehti haavast foto pimemeetodil hindamiseks.
English: What Episalvan looks like and contents of the pack Episalvan is a colourless to slightly yellowish, opalescent gel.
Estonian: Kuidas Episalvan välja näeb ja pakendi sisu Episalvan on värvitu kuni kergelt kollakas hägune geel.
English: If you forget to use Episalvan
Estonian: Kui te unustate Episalvani kasutada
English: Wound infection is a serious complication that can occur during the healing process.
Estonian: Haavainfektsioon on raske tüsistus, mis võib tekkida paranemisprotsessi ajal.
English: Episalvan should be used as advised by your doctor or nurse.
Estonian: Episalvani tuleb kasutada nii, nagu arst või meditsiiniõde on teile selgitanud.
English: Discard after use.
Estonian: Pärast kasutamist minema visata.
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.
Estonian: Patsientide ühe alarühma korral näitas fotode pimemeetodil hindamine paremaid tulemusi Episalvaniga ravitud haavapoole kohta võrrelduna standardraviga (hinnati varasemate haavapiirkondade pigmentatsiooni, punetust ja tekstuuri).
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).
Estonian: Episalvaniga ravitud keskmine haava suurus kliinilistes uuringutes osalise nahasiiriku (split thickness skin grafting) doonori haavakohtadel oli 40,7 cm² (vahemik 8…300 cm²).
English: • If necessary, wounds should be cleansed using a suitable antiseptic solution prior to application of Episalvan
Estonian: • Vajaduse korral tuleb enne Episalvani manustamist haavad puhastada sobiva antiseptilise lahusega.
English: Rash pruritic Purpura
Estonian: Sügelev lööve Purpur
English: Wound size
Estonian: Haava suurus
English: Extraction solvent: n-Heptane
Estonian: Ekstraheerimislahusti: n-heptaan
English: Hypersensitivity to the active substance or to the excipient listed in section 6.1.
Estonian: Ülitundlikkus toimeaine või lõigus 6.1 loetletud mis tahes abiaine suhtes.
English: Extraction solvent: n-heptane.
Estonian: Ekstraheerimislahusti: n-heptaan.
English: Mean intra-patient difference in time to wound closure (95% epithelialisation)
Estonian: Keskmine patsiendisisene haava sulgumise (95% epitelisatsioon) ajaline erinevus
English: 75223 Niefern-Öschelbronn Germany tel +49 (0) 7233 9749 - 0 fax +49 (0) 7233 9749 - 210 Email: info.de@amrytpharma.com
Estonian: Faks +49 (0) 723 3974 9210 E-post info.de@amrytpharma.com
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.
Estonian: 2a astme põletushaavade uuringu esmane tulemusnäitaja oli varasema paranemisega (vähemalt 95% epitelisatsioon) patsientide protsent pimemeetodil fotode hindamiste alusel.
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
Estonian: Kõige sagedamini teatatud kõrvaltoimed Sageli esinevad kõrvaltoimed (võivad esineda kuni 1 inimesel 10-st): - naha valulikkus, - sügelus, - haava paranemisprotsessi tühistused.
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.
Estonian: Episalvani mõju viljakusele ei ole uuritud ja et seda ravimit imendub organismi väga vähe, ei ole oodata, et sellel oleks mõju teie viljakusele.
English: Since the systemic exposure of Episalvan following cutaneous application is negligible no interaction with systemic treatments is expected.
Estonian: Kuna nahale manustamise järgselt on Episalvani süsteemne ekspositsioon ebaoluline, ei ole oodata koostoimeid süsteemsete ravimitega.
English: Fresh wounds should achieve haemostasis prior to application of Episalvan.
Estonian: Värsketel haavadel tuleb enne Episalvani nahale kandmist saavutada hemostaas.
English: If you stop using Episalvan
Estonian: Kui te lõpetate Episalvani kasutamise
English: Pack size:1 tube of 23.4 g gel.
Estonian: Pkendi suurus: 1 tuub 23,4 g geeliga.
English: If necessary, wounds (accidental wounds) should be cleaned according to standard procedure, using e.g. wound antiseptic solution, prior to application of Episalvan.
Estonian: Vajadusel tuleb enne Episalvani nahale kandmist haavu (juhuslikke haavu) puhastada standardprotseduuri kohaselt, kasutades nt antiseptilist haavalahust.
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.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS 1 g geeli sisaldab: 100 mg kasetohuekstrakti (rafineeritud kuivekstraktina), mis pärineb Betula pendula Roth'ilt, Betula pubescens Ehrh.