FrancophonIA/ELRC3.0 huggingface dataset:
English: The Phase III studies were blindly evaluated, prospective, intra-individually controlled, randomised, multicentre trials.
Croatian: Ispitivanja faze III bila su , prospektivna, intraindividualno kontrolirana, randomizirana, multicentrična ispitivanja procjenjivana na slijepo
English: See section 4.4 and 5.1 with respect to type of wounds studied.
Croatian: Vidjeti dio 4.4 i 5.1 u vezi s vrstom ispitivanih rana.
English: Other medicines and Episalvan
Croatian: Drugi lijekovi i Episalvan
English: The most frequently observed adverse reactions were wound complication (in 2.9% of patients), pain of skin (2.5%) and pruritus (1.3%).
Croatian: Najčešće primijećene nuspojave bile su komplikacije rane (u 2,9 % bolesnika), bol kože (2,5 %) i svrbež (1,3 %).
English: If you use more Episalvan than you should Episalvan is applied to the skin and the absorption into the body is minimal.
Croatian: Ako primijenite više Episalvana nego što ste trebali Episalvan se nanosi na kožu i njegova apsorpcija u tijelo je minimalna.
English: Median time to wound healing was 7.3 days.
Croatian: Srednje vrijeme cijeljenja rane iznosilo je 7,3 dana.
English: Other topical products should not be concomitantly used together with Episalvan but rather sequentially or alternatively depending on the clinical need.
Croatian: Drugi topikalni pripravci ne bi se smjeli upotrebljavati istodobno s Episalvanom, nego naknadno ili na neki drugi način ovisno o kliničkoj potrebi.
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.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja Episalvana u jednoj ili više podskupina pedijatrijske populacije za liječenje ozljeda kože.
English: • Once the single-use tube has been opened, use the gel immediately and discard the tube, even if there's some left.
Croatian: • Jednom kada se tuba za jednokratnu uporabu otvori, odmah upotrijebite gel i bacite tubu, čak i ako u njoj još uvijek ima gela.
English: Repeated critical assessment of burn depth and healing progression is needed.
Croatian: Potrebna je opetovana kritička procjena dubine opekline i napretka cijeljenja.
English: Interactions with topical products have not been investigated in clinical trials.
Croatian: Interakcije s topikalnim pripravcima nisu bile ispitivane u kliničkim ispitivanjima.
English: Once opened, the product should be used immediately and be discarded after use.
Croatian: Jednom kada se otvori, lijek treba odmah upotrijebiti i baciti nakon uporabe.
English: What Episalvan is and what it is used for 2.
Croatian: Što je Episalvan i za što se koristi 2.
English: Marketing Authorisation Holder and Manufacturer Amryt AG
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Amryt AG
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
Croatian: CI: interval pouzdanosti od 95 %; PVPK: prosječno vrijeme do promjene komprese; N: broj bolesnika u skupini za analizu; KPDD kožni presadak djelomične debljine
English: In consequence a substantial number of photographs were excluded and not presented in the primary blinded read because of apparent gel residues.
Croatian: Stoga je isključen znatan broj fotografija te nije prikazan u primarnom očitanju na slijepo zbog vidljivih ostataka gela.
English: In the case of infection, it is recommended to discontinue treatment with Episalvan.
Croatian: U slučaju infekcije, preporučuje se prekidanje liječenja Episalvanom.
English: Photographs of the wound were taken at each visit for the blinded evaluation.
Croatian: Fotografije rane snimljene su pri svakom posjetu za procjenu na slijepo.
English: See section 4.4 with respect to wound size and duration of treatment.
Croatian: Vidjeti dio 4.4 u vezi s veličinom rane i trajanjem liječenja.
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).
Croatian: Od bolesnika s razlikom između liječenja u cijeljenju rane (N = 35), postotak bolesnika kod kojih je došlo do ranijeg cijeljenja (primarni ishod) polovice rane liječene Episalvanom (85,7 % [95 % CI: 69,7 %, 95,2 %]) bio je veći nego postotak bolesnika kod kojih je došlo do ranijeg cijeljenja kontrolne polovice rane liječene standardnim postupcima (14,3 % [95 % CI: 4,8 %, 30,3 %]) (p < 0,0001, binomialni test).
English: Episalvan should be used as advised by your doctor or nurse.
Croatian: Episalvan je potrebno primjenjivati u skladu sa savjetima svojeg liječnika ili medicinske sestre.
English: What Episalvan is and what it is used for
Croatian: Što je Episalvan i za što se koristi
English: What you need to know before you use Episalvan 3.
Croatian: Što morate znati prije nego počnete primjenjivati Episalvan 3.
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.
Croatian: Iskustva primjene Episalvana u djece i adolescenata u dobi do 18 godina nisu dostatna, pa se stoga ne smije primjenjivati u tih bolesnika.
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.
Croatian: Mogući su znakovi infekcije rane ako iz nje počne istjecati žuta ili zelenkasta tekućina (gnoj) ili ako koža oko rane postane crvena, topla, otečena ili pojačano bolna.
English: Episalvan has no influence on the ability to drive and use machines.
Croatian: Episalvan ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment, see section 5.2.
Croatian: Nisu predviđena prilagodba doze ili posebna razmatranja za bolesnike s oštećenjem funkcije bubrega ili jetre, vidjeti dio 5.2.
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.
Croatian: Rane za koje se procijeni da ne mogu zacijeliti unutar prihvatljivog vremenskog okvira mogu zahtijevati kirurške mjere (npr. pokrivanje kožnim presadcima djelomične debljine) kako bi se smanjila mogućnost nastanka hipertrofičnog ožiljka.
English: Episalvan should be used until the wound is healed or up to 4 weeks.
Croatian: Episalvan je potrebno primjenjivati dok rana ne zacijeli ili najviše do 4 tjedna.
English: Episalvan gel is packed in white collapsible aluminium tubes.
Croatian: Episalvan gel zapakiran je u bijele savitljive aluminijske tube.
English: No data are available on possible interaction between Episalvan and other medicines applied to the skin.
Croatian: Nisu dostupni podaci o mogućoj interakciji između Episalvana i drugih lijekova koji se nanose na kožu.
English: Duration of use There is no information available on clinical use of Episalvan for more than 4 weeks.
Croatian: Trajanje uporabe Nema dostupnih informacija o kliničkoj uporabi Episalvana dulje od 4 tjedna.
English: Do not apply other products to the skin wound area at the same time of applying Episalvan.
Croatian: Nemojte nanositi druge pripravke na područje kože s ranom istovremeno s nanošenjem Episalvana.
English: Table 1: Adverse reactions reported in clinical trials System organ class
Croatian: Tablica 1.: Nuspojave prijavljene u kliničkim ispitivanjima Klasifikacija organskih sustava Često
English: Wound infection
Croatian: Infekcija rane
English: The precise mechanism of action of the active substance in wound healing in humans is not known.
Croatian: Točan mehanizam djelovanja djelatne tvari na cijeljenje rana u ljudi nije poznat.
English: The active substance was not genotoxic in in vitro assays.
Croatian: Djelatna tvar nije bila genotoksična u in vitro testovima.
English: OUTER CARTON and TUBE
Croatian: VANJSKA KUTIJA i TUBA
English: The secondary blinded read was conducted with all photographs presented to the blinded observers.
Croatian: Sekundarno očitanje na slijepo provedeno je prikazivanjem svih fotografija zaslijepljenim promatračima.
English: 75223 Niefern-Öschelbronn Germany tel +49 (0) 7233 9749 - 0 fax +49 (0) 7233 9749 - 210 Email: info.de@amrytpharma.com
Croatian: +49 (0) 7233 9749 - 0 telefaks +49 (0) 7233 9749 - 210 E-pošta: 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.
Croatian: Na kontrolnim posjetima tri i 12 mjeseci nakon dana operacije ili ozljede izazvane opeklinama, pokazalo se da su liječene polovice rana u većine bolesnika bile jednake s obzirom na pigmentaciju, crvenilo, teksturu i rast dlačica regeneriranog epidermisa.
English: The other ingredient is refined sunflower oil.
Croatian: Drugi je sastojak rafinirano suncokretovo ulje.
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.
Croatian: Na temelju podataka iz triju kliničkih ispitivanja u kojima je sudjelovalo ukupno 280 bolesnika, nanošenje Episalvana na otvorene rane nije dovelo do razina betulina u plazmi koje su veće od prirodnih temeljnih razina koje primjerice potječu iz nutritivnih izvora.
English: Mean intra-patient difference in time to wound closure (95% epithelialisation)
Croatian: Prosječne intraindividualne razlike u vremenu do zatvaranja rane (95 % epitelizacije)
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.
Croatian: Mehanizam djelovanja i farmakodinamički učinci Djelatna tvar ubrzala je ponovnu epitelizaciju kod in vitro testa grebanjem rane uporabom ljudskih primarnih keratinocita u dozi od 1 μg/ml te kod svinjskoga ex vivo modela cijeljenja rane u dozi od 10 µg/ml.
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.
Croatian: Komplikacije rane* * Komplikacije rane obuhvaćaju različite oblike lokalnih komplikacija, kao što su komplikacije nakon zahvata, nekroza rane, sekrecija iz rane, usporeno cijeljenje ili upala rane.
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.
Croatian: Međutim, budući da je količina Episalvana koja se apsorbira u tijelo iznimno niska, ne očekuje se interakcija Episalvana s drugim lijekovima.
English: Median time to wound healing was 14 days.
Croatian: Srednje vrijeme do cijeljenja rane iznosilo je 14 dana.
English: Adverse reactions were administration site reactions only.
Croatian: Nuspojave su se pojavile samo kao reakcije na mjestu primjene.
English: What Episalvan looks like and contents of the pack Episalvan is a colourless to slightly yellowish, opalescent gel.
Croatian: Kako Episalvan izgleda i sadržaj pakiranja Episalvan je bezbojan do blago žućkast, opalescentan gel.
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.
Croatian: Osim toga, u literaturi je zabilježen jedan prikaz slučaja kontaktnog dermatitisa u bolesnika nakon produljene uporabe kozmetičkog proizvoda koji sadrži ekstrakt brezove kore za topikalnu primjenu.
English: However, wound infection is an important and serious complication that can occur during wound healing.
Croatian: Međutim, infekcija rane predstavlja važnu i ozbiljnu komplikaciju koja se može pojaviti tijekom cijeljenja rane.
English: INFORMATION IN BRAILLE Episalvan gel (carton only)
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Episalvan gel (samo na kutiji)
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).
Croatian: . Ciljno područje rane svakog bolesnika podijeljeno je na dva područja liječenja približno jednake veličine; raspodjela liječenja na dvije polovice rane (distalna naspram proksimalna) određena je randomizacijom (kod ispitivanja opeklina mogle su se upotrijebiti dvije slične rane).
English: Discard after use.
Croatian: Baciti nakon uporabe.
English: Observer-blinded photo assessment (blinded read), mean expert evaluation primary blinded read / very conservative calculation (primary endpoint for STSG studies)
Croatian: Procjena fotografija od strane zaslijepljenog promatrača (očitanje na slijepo), prosječna stručna procjena primarno očitanje na slijepo / vrlo konzervativan izračun (primarni ishod za ispitivanja kožnih presadaka djelomične debljine)
English: Hypersensitivity to the active substance or to the excipient listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili pomoćnu tvar navedenu u dijelu 6.1.
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).
Croatian: Ako zatvaranje rane nije opaženo u seriji fotografija polovice rane, računalo se da se zatvaranje dogodilo jedan dan nakon posljednje fotografije u seriji. „Manje konzervativan izračun” razlikuje se od „vrlo konzervativnog izračuna” u jednom aspektu: ako zatvaranje rane nije opaženo u seriji fotografija polovice rane, računalo se da se zatvaranje dogodilo ne jedan dan poslije, nego oko 3 dana poslije (prosječni vremenski interval između promjene komprese u ispitivanjima).
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).
Croatian: Polovice rana liječenih Episalvanom zacijelile su brže nego polovice rana liječenih standardnim postupcima (prosječno 1,1 dan prema primarnim ishodima, p < 0,0001, dvostrani upareni t-test).
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.
Croatian: Nuspojave povezane s komplikacijama rane, kao što su infekcija rane i nekroza rane, predstavljaju komplikacije cijeljenja rana koje zahvaćaju djelomičnu debljinu kože i mogu biti ozbiljne.
English: Treatment of partial thickness wounds in adults.
Croatian: Liječenje rana koje zahvaćaju djelomičnu debljinu kože u odraslih.
English: Episalvan is safe to use for people who are allergic to birch pollen, as these allergens are not present in Episalvan.
Croatian: Episalvan je siguran za primjenu u osoba alergičnih na polen breze, jer Episalvan ne sadrži te alergene.
English: Pack size: 1 single-use tube containing 23.4 g gel.
Croatian: Veličina pakiranja: 1 tuba za jednokratnu uporabu s 23,4 g gela.
English: Wound infection is a serious complication that can occur during the healing process.
Croatian: Infekcija rane predstavlja ozbiljnu komplikaciju koja se može pojaviti tijekom postupka cijeljenja.
English: There is no experience from long-term use of Episalvan for more than 4 weeks.
Croatian: Ne postoje iskustva o dugotrajnoj uporabi Episalvana dulje od 4 tjedna.
English: Since the systemic exposure of Episalvan following cutaneous application is negligible no interaction with systemic treatments is expected.
Croatian: Budući da je sistemska izloženost Episalvanu nakon primjene na koži zanemariva, ne očekuju se interakcije sa sistemskim liječenjem.
English: -1.1 days (CI: -1.5, -0.7) faster wound closure with Episalvan, p<0.0001a
Croatian: -1,1 dan (CI: -1,5, -0,7) brže zatvaranje rane s Episalvanom, p < 0,0001a
English: This product is for single use only and once opened, the product should be used immediately.
Croatian: Ovaj lijek isključivo je za jednokratnu uporabu i treba ga upotrijebiti odmah nakon otvaranja.
English: Episalvan does not contain birch pollen, so it may be used by people with birch pollen allergy.
Croatian: Episalvan ne sadrži polen breze, pa ga mogu upotrebljavati osobe alergične na polen breze.
English: • Re-apply the gel each time the dressing is changed, until the wound is healed.
Croatian: • Ponovno nanesite gel pri svakoj promjeni komprese sve dok rana ne zacijeli.
English: NAME OF THE MEDICINAL PRODUCT Episalvan gel
Croatian: NAZIV LIJEKA Episalvan gel
English: The gel should be re-applied at each wound dressing change, until the wound is healed, for up to 4 weeks.
Croatian: Gel je potrebno ponovno nanijeti pri svakoj promjeni komprese, sve dok rana ne zacijeli, najviše do 4 tjedna.
English: Pain of skin
Croatian: Bol kože
English: Colourless to slightly yellowish, opalescent.
Croatian: Bezbojan do blago žućkast, opalescentan.
English: Extraction solvent: n-heptane.
Croatian: Otapalo za ekstrakciju: n-heptan.
English: Birch pollen allergy
Croatian: Alergija na polen breze
English: 75223 Niefern-Öschelbronn Germany tel +49 (0) 7233 9749 - 0 fax+49 (0) 7233 9749 - 210
Croatian: +49 (0) 7233 9749 - 0 telefaks +49 (0) 7233 9749 - 210
English: What you need to know before you use Episalvan
Croatian: Što morate znati prije nego počnete primjenjivati Episalvan
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.
Croatian: podskupini bolesnika procjena fotografija na slijepo pokazala je bolje rezultate za polovice rana liječenih Episalvanom u usporedbi sa standardnim postupcima s obzirom na pigmentaciju, crvenilo i teksturu područja prijašnjih rana.
English: In the following table, adverse reactions are listed by MedDRA system organ class and preferred term.
Croatian: Nuspojave su u sljedećoj tablici navedene prema MedDRA-inoj klasifikaciji organskih sustava i preporučenom izrazu.
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.
Croatian: Primjenjuje se u odraslih za liječenje rana na koži, koje su nastale primjerice zbog opeklina 2.a stupnja ili kirurške transplantacije kožnog presatka.
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
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): - infekcija rane - alergijska reakcija (preosjetljivost) - iritacija kože (dermatitis) - osip praćen svrbežom - osip ljubičaste boje - bol
English: Episalvan gel is a herbal medicinal product which contains dry extract from birch bark.
Croatian: Episalvan gel je biljni lijek koji sadrži suhi ekstrakt iz brezove kore.
English: If necessary, wounds (accidental wounds) should be cleaned according to standard procedure, using e.g. wound antiseptic solution, prior to application of Episalvan.
Croatian: Ako je potrebno, rane (slučajne rane) treba očistiti u skladu sa standardnim postupkom, uporabom npr. antiseptičke otopine za rane, prije nanošenja Episalvana.
English: Toxicity studies of longer duration than 4 weeks have not been performed.
Croatian: Nisu provedena ispitivanja toksičnosti u trajanju duljem od 4 tjedna.
English: Wound size
Croatian: Veličina rane
English: • If necessary, wounds should be cleansed using a suitable antiseptic solution prior to application of Episalvan
Croatian: • Ako je potrebno rane treba očistiti uporabom odgovarajuće antiseptičke otopine prije nanošenja Episalvana
English: Breast-feeding No data are available to evaluate whether Episalvan is excreted into human milk.
Croatian: Dojenje Nema dostupnih podataka za procjenu izlučuje li se Episalvan u majčino mlijeko.
English: Pack size:1 tube of 23.4 g gel.
Croatian: Veličina pakiranja: 1 tuba s 23,4 g gela.
English: Episalvan gel is administered topically to skin wounds and shows poor absorbtion.
Croatian: Episalvan gel primjenjuje se topikalno na rane na koži te pokazuje slabu apsorpciju.
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.
Croatian: Gel se nanosio pri svakoj promjeni komprese svaka tri do četiri dana sve do potpunog zatvaranja rane najviše do 28 dana u ispitivanjima kožnih presadaka djelomične debljine te svaka dva dana najviše do 21 dan u ispitivanju opeklina 2.a stupnja.
English: • Episalvan should be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile wound dressing.
Croatian: • Episalvan je potrebno nanijeti na površinu rane u sloju od oko 1 mm i prekriti sterilnom kompresom.
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.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
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).
Croatian: Srednja vrijednost površine rane liječene Episalvanom u kliničkim ispitivanjima rana donorskog mjesta kožnog presatka djelomične debljine iznosila je 40,7 cm² (raspon 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.
Croatian: Nije poznato prelazi li Episalvan u majčino mlijeko, ali s obzirom na to da je apsorpcija ovog lijeka u tijelo minimalna, rizik za dijete je zanemariv.
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.
Croatian: Primarni ishod dvaju ispitivanja kožnih presadaka djelomične debljine bila je intraindividualna razlika u vremenu zatvaranja rane (najmanje 95 % epitelizacije) na temelju procjena fotografija na slijepo.
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.
Croatian: Primarni ishod ispitivanja rana izazvanih opeklinama 2.a stupnja bio je postotak bolesnika s ranijim cijeljenjem (najmanje 95 % epitelizacije) na temelju procjena fotografija na slijepo.
English: No effects on human fertility are anticipated, since the systemic exposure is negligible.
Croatian: Ne očekuju se učinci na ljudsku plodnost jer je sistemska izloženost zanemariva.
English: LIST OF EXCIPIENTS Excipient: Sunflower oil.
Croatian: POPIS POMOĆNIH TVARI Pomoćna tvar: suncokretovo ulje.
English: No data have been generated to study the effect of accidental ingestion of Episalvan.
Croatian: Ne postoje podaci za ispitivanje učinka slučajnog gutanja Episalvana.