FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Preparation for treatment of wounds and ulcers; ATC code: D03AX13 .
Slovenian: Farmakoterapevtska skupina: Zdravila za oskrbo ran in razjed oznaka, oznaka ATC: D03AX13.
English: Episalvan can be used during pregnancy.
Slovenian: Zdravilo Episalvan se lahko uporablja med nosečnostjo.
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
Slovenian: CI: 95-odstotni interval zaupanja; MTWDC: povprečen čas med zamenjavo povoja rane; N: število bolnikov, vključenih v nabor za analizo; STSG: presadek delne debeline kože.
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).
Slovenian: Zdravila Episalvan ne uporabljajte - če ste alergični na skorjo breze ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30°C.
English: In consequence a substantial number of photographs were excluded and not presented in the primary blinded read because of apparent gel residues.
Slovenian: Tako so veliko število fotografij izključili in jih niso preložili v primarnem slepem branju, saj so bili na njih vidni očitni ostanki gela.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1069/001
Slovenian: EU/1/15/1069/001
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.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Episalvan za eno ali več podskupin pediatrične populacije za zdravljenje poškodb kože.
English: The most frequently observed adverse reactions were wound complication (in 2.9% of patients), pain of skin (2.5%) and pruritus (1.3%).
Slovenian: Najpogosteje zabeleženi neželeni učinki so bili zapleti pri rani (pri 2,9 % bolnikov), boleča koža (2,5 %) in pruritus (1,3 %).
English: Table 1: Adverse reactions reported in clinical trials System organ class
Slovenian: Preglednica 1: Neželeni učinki, o katerih so poročali v kliničnih preskušanjih Razvrstitev po organskih sistemih
English: Median time to wound healing was 7.3 days.
Slovenian: Mediana časa do zacelitve rane je bila 7,3 dneva.
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).
Slovenian: „Manj konzervativen izračun“ se razlikuje od „zelo konzervativnega izračuna“ v enem pogledu: Če zaprtje rane ni bilo zabeleženo v seriji fotografij polovice rane, so izračunali, da je do zaprtja ni prišlo en dan po zadnji fotografiji v seriji, temveč 3 dni kasneje (povprečni časovni interval med zamenjavo povoja rane v študijah).
English: Other topical products should not be concomitantly used together with Episalvan but rather sequentially or alternatively depending on the clinical need.
Slovenian: Drugih zdravil za topikalno uporabo se ne sme uporabljati skupaj z zdravilom Episalvan, ampak naj bo uporaba zaporedna ali izmenična, odvisno od klinične potrebe.
English: The secondary blinded read was conducted with all photographs presented to the blinded observers.
Slovenian: Sekundarno slepo ocenjevanje so izvedli tako, da so slepim opazovalcem predložili vse fotografije.
English: Episalvan gel is packed in white collapsible aluminium tubes.
Slovenian: Episalvan gel je pakiran v belih upogljivih aluminijastih tubah.
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.
Slovenian: Z uporabo zdravila Episalvan pri otrocih in mladostnikih, mlajših od 18 let, ni dovolj izkušenj, zato se zdravilo pri teh bolnikih ne sme uporabljati.
English: 'Very conservative calculation' means that the first observation of wound closure was taken as time of wound closure.
Slovenian: „Zelo konzervativen izračun“ pomeni, da je bilo prvo zaprtje rane zabeleženo ob zaprtju rane.
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).
Slovenian: Od bolnikov, pri katerih so opazili razliko v celjenju rane med zdravljenjem (N = 35), je bil odstotek bolnikov, pri katerih so ugotovili prejšnje celjenje (primarni cilj) polovice rane, zdravljene z zdravilom Episalvan (85,7 % [95 % CI: 69,7 %, 95,2 %]), višji od odstotka tistih bolnikov, pri katerih so ugotovili prejšnje celjenje kontrolne polovice rane, ki so jo zdravili s standardno oskrbo (14,3 % [95 % CI: 4,8 %, 30,3 %]) (p < 0,0001, binomialni test).
English: Episalvan has no influence on the ability to drive and use machines.
Slovenian: Zdravilo Episalvan nima vpliva na sposobnost vožnje in upravljanja strojev.
English: Median time to wound healing was 14 days.
Slovenian: Mediana časa do zacelitve rane je bila 14 dni.
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.
Slovenian: Možni znaki okužbe rane so izločanje rumene ali zelene tekočine iz rane (gnoj) ali pa da postane koža okoli rane rdeča, topla, zatečena ali bolj boleča.
English: ‘Primary' vs. ‘secondary' blinded read: In the primary blinded read evaluation a rigorous quality check was implemented to assure blinding of the observers.
Slovenian: "Primarno" vs. "sekundarno" slepo ocenjevanje: Pri primarnem slepem ocenjevanju so za zagotovitev slepote opazovalcev opravili strog nadzor kakovosti.
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.
Slovenian: Če zaprtje rane ni bilo zabeleženo v seriji fotografij polovice rane, so izračunali, da je do zaprtja prišlo en dan po zadnji fotografiji v seriji.
English: Observer-blinded photo assessment (blinded read), mean expert evaluation primary blinded read / very conservative calculation (primary endpoint for STSG studies)
Slovenian: Ocenjevanje fotografij s slepim opazovalcem (slepo ocenjevanje), povprečna strokovna ocena primarno slepo ocenjevanje / zelo konzervativen izračun (primaren cilj za študiji STSG)
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.
Slovenian: Poleg tega so v enem primeru iz literature poročali o kontaktnem dermatitisu pri bolniku po dolgotrajni uporabi ekstrakta skorje breze za topikalno uporabo, ki ga je vseboval kozmetični izdelek.
English: If you have an infection in the wound additional treatment may be required.
Slovenian: Če je vaša rana okužena, boste morda potrebovali dodatno zdravljenje.
English: The other ingredient is refined sunflower oil.
Slovenian: Druga sestavina je rafinirano sončnično olje.
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.
Slovenian: Rane, za katere se oceni, da se ne bodo mogle zaceliti v sprejemljivem časovnem obdobju, je morda treba kirurško oskrbeti (npr. presadek delne debeline kože) za zmanjšanje tveganja prekomernega brazgotinjenja.
English: Grade 2a burn wound study
Slovenian: Študija opeklin stopnje 2a
English: Marketing Authorisation Holder and Manufacturer Amryt AG
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Amryt AG
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.
Slovenian: Uporablja se pri odraslih za zdravljenje kožnih ran, ki so na primer posledica opeklin stopnje 2a ali kirurške odstranitve kože za presaditev.
English: Toxicity studies of longer duration than 4 weeks have not been performed.
Slovenian: Študij toksičnosti za obdobje, daljše od 4 tednov, niso izvedli.
English: • Once the single-use tube has been opened, use the gel immediately and discard the tube, even if there's some left.
Slovenian: • Po odprtju tube za enkratno uporabo nemudoma uporabite gel in tubo zavrzite, tudi če niste porabili celotne vsebine.
English: Do not use this medicine after the expiry date which is stated on the carton and tube after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in tubi poleg oznake „Uporabno do“.
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).
Slovenian: Izvedli so tri študije faze III za oceno učinkovitosti in varnosti zdravila Episalvan pri zdravljenju ran delne debeline kože: dve študiji, ki sta preiskovali mesto odvzema presadka delne debeline kože, ki je vključevala skupno 219 bolnikov (ITT: N = 217), in eno nadaljnjo študijo na 61 bolnikih z opeklinami stopnje 2a (ITT: N = 57).
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.
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: INFORMATION IN BRAILLE Episalvan gel (carton only)
Slovenian: PODATKI V BRAILLOVI PISAVI Episalvan gel (samo na škatli)
English: Repeated dose toxicity and local tolerance have been studied for up to 4 weeks.
Slovenian: Toksičnost pri ponavljajočih se odmerkih in lokalno prenašanje sta bila raziskovana za obdobje do 4 tednov.
English: Photographs of the wound were taken at each visit for the blinded evaluation.
Slovenian: Rano so fotografirali ob vsakem obisku za slepo oceno.
English: Do not stop using it without consulting your doctor or nurse.
Slovenian: Ne prenehajte ga uporabljati brez posveta s svojim zdravnikom ali medicinsko sestro.
English: Interactions with topical products have not been investigated in clinical trials.
Slovenian: Medsebojnega delovanja z zdravili za topikalno uporabo niso raziskali v kliničnih študijah.
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.
Slovenian: Mehanizem delovanja in farmakodinamični učinki Zdravilna učinkovina je pospešila reepitelizacijo pri preizkusu in vitro s praskanjem rane z uporabo humanih primarnih keratinocitov z odmerkom 1 μg/ml in pri modelu celjenja rane ex vivo pri prašičih z odmerkom 10 µg/ml.
English: What Episalvan is and what it is used for 2.
Slovenian: Kaj je zdravilo Episalvan in za kaj ga uporabljamo 2.
English: What you need to know before you use Episalvan 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Episalvan 3.
English: Wound infection
Slovenian: Okužbe ran
English: Episalvan is safe to use for people who are allergic to birch pollen, as these allergens are not present in Episalvan.
Slovenian: Zdravilo Episalvan je varno za uporabo pri ljudeh, alergičnih na cvetni prah breze, saj ti alergeni v zdravilu Episalvan niso prisotni.
English: However, wound infection is an important and serious complication that can occur during wound healing.
Slovenian: Vendar pa so okužbe ran pomemben in resen zaplet, ki se lahko pojavi med celjenjem rane.
English: No data are available on possible interaction between Episalvan and other medicines applied to the skin.
Slovenian: Podatkov o možnih medsebojnih delovanjih zdravila Episalvan in drugih zdravil, ki se jih nanaša na kožo, ni na voljo.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: In the following table, adverse reactions are listed by MedDRA system organ class and preferred term.
Slovenian: V naslednji preglednici so neželeni učinki razvrščeni v skladu s klasifikacijo organov v sistemu MedDRA in najustreznejšimi izrazi.
English: Rash pruritic Purpura
Slovenian: Pruritus pruritusni izpuščaj purpura
English: The precise mechanism of action of the active substance in wound healing in humans is not known.
Slovenian: Točen mehanizem delovanja zdravilne učinkovine pri celjenju rane pri ljudeh ni znan.
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.
Slovenian: Pri kontrolnih pregledih po 3 in 12 mesecih po operaciji ali opeklini so ugotovili, da so pri večini bolnikov obe polovici rane enaki kar zadeva pigmentacijo, pordelost, teksturo in poraščenost regeneriranega epidermisa.
English: Pack size: 1 single-use tube containing 23.4 g gel.
Slovenian: Velikost pakiranja: 1 tuba za enkratno uporabo, ki vsebuje 23,4 g gela.
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).
Slovenian: Ciljna površina rane vsakega bolnika je bila razdeljena na dve približno enako veliki področji zdravljenja; razdelitev zdravljenja na dve polovici rane (distalno vs. proksimalno) je bila določena naključno (pri študiji opeklin so lahko uporabili dve podobni rani).
English: If you use more Episalvan than you should Episalvan is applied to the skin and the absorption into the body is minimal.
Slovenian: Če ste uporabili večji odmerek zdravila Episalvan, kot bi smeli Zdravilo Episalvan se nanese na kožo in njegova absorpcija v telo je minimalna.
English: Hypersensitivity to the active substance or to the excipient listed in section 6.1.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: 75223 Niefern-Öschelbronn Germany tel +49 (0) 7233 9749 - 0 fax +49 (0) 7233 9749 - 210 Email: info.de@amrytpharma.com
Slovenian: Tel.: +49 (0) 7233 9749 - 0 Faks: +49 (0) 7233 9749 - 210 E-pošta: info.de@amrytpharma.com
English: Episalvan is for single use only.
Slovenian: Zdravilo Episalvan je samo za enkratno uporabo.
English: -1.1 days (CI: -1.5, -0.7) faster wound closure with Episalvan, p<0.0001a
Slovenian: -1,1 dneva (CI: -1,5, -0,7) hitrejše zapiranje rane z zdravilom Episalvan, p < 0,0001a
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).
Slovenian: Polovice ran, zdravljene z zdravilom Episalvan, so se celile hitreje kot polovice ran, zdravljene z običajno oskrbo (povprečno 1,1 dneva glede na primarne cilje, p < 0,0001, dvostranski parni t-test).
English: Mean intra-patient difference in time to wound closure (95% epithelialisation)
Slovenian: Povprečna razlika v času do zaprtja rane med bolniki (95-odstotna epitelizacija)
English: Once opened, the product should be used immediately and be discarded after use.
Slovenian: Po odprtju je treba zdravilo nemudoma uporabiti in ga po uporabi zavreči.
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.
Slovenian: Na podlagi podatkov iz treh kliničnih študij, ki so skupaj vključevale 280 bolnikov, nanos zdravila Episalvan gel na odprte rane ni povečalo naravno prisotne ravni betulina v plazmi, ki izhaja iz prehranskih virov.
English: What Episalvan looks like and contents of the pack Episalvan is a colourless to slightly yellowish, opalescent gel.
Slovenian: Izgled zdravila Episalvan in vsebina pakiranja Zdravilo Episalvan je brezbarven do rahlo rumenkast, opalescenten gel.
English: Other medicines and Episalvan
Slovenian: Druga zdravila in zdravilo Episalvan
English: Colourless to slightly yellowish, opalescent.
Slovenian: gel brezbarven do rahlo rumenkast, opalescenten
English: In the case of infection, it is recommended to discontinue treatment with Episalvan.
Slovenian: V tem primeru se priporoča prekinitev zdravljenja z zdravilom Episalvan.
English: Wound size
Slovenian: Velikost rane
English: • Re-apply the gel each time the dressing is changed, until the wound is healed.
Slovenian: • Gel ponovno nanesite ob vsaki menjavi povoja, dokler ni rana zaceljena.
English: Apply Episalvan at the next planned change of the wound dressing, continuing with your normal routine.
Slovenian: Zdravilo Episalvan nanesite ob naslednji predvideni menjavi povoja in nadaljujte z običajnim postopkom nanosa.
English: No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment, see section 5.2.
Slovenian: Pri bolnikih z okvaro ledvic ali jeter ni treba prilagajati odmerka ali biti posebno pozoren, glejte poglavje 5.2.
English: Do not apply other products to the skin wound area at the same time of applying Episalvan.
Slovenian: Ne nanašajte drugih zdravil sočasno na območje kože, na katerega nanašate zdravilo Episalvan.
English: The gel should be re-applied at each wound dressing change, until the wound is healed, for up to 4 weeks.
Slovenian: Gel je treba ponovno nanesti pri vsakem previjanju rane, dokler ni rana zaceljena, do 4 tedne.
English: Fertility studies have not been conducted.
Slovenian: Študij plodnosti niso izvedli.
English: Extraction solvent: n-heptane.
Slovenian: Ekstrakcijsko topilo: n-heptan.
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.
Slovenian: Neželeni učinki, povezani z zapleti pri ranah, kot sta okužba in nekroza rane, so zapleti pri celjenju ran delne debeline kože in so lahko resni.
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
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri do 1 osebi od 100): - okužbe ran - alergijska reakcija (preobčutljivost) - draženje kože (dermatitis) - srbeč izpuščaj - izpuščaj vijolične barve - bolečina
English: Episalvan should be used until the wound is healed or up to 4 weeks.
Slovenian: Zdravilo Episalvan uporabljajte, dokler se rana ne zaceli ali do 4 tedne.
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.
Slovenian: Ni znano, ali zdravilo Episalvan prehaja v materino mleko, ker pa je absorpcija tega zdravila v telo minimalna, je tveganje za otroka zanemarljivo.
English: Intention-to-treat (ITT) data set.
Slovenian: Nabor podatkov namen zdraviti (ITT).
English: Pack size:1 tube of 23.4 g gel.
Slovenian: Velikost pakiranja: 1 tuba s 23,4 g gela.
English: Episalvan gel is a herbal medicinal product which contains dry extract from birch bark.
Slovenian: Episalvan gel je zdravilo rastlinskega izvora, ki vsebuje suh ekstrakt skorje breze.
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.
Slovenian: * Zapleti pri rani obsegajo različne vrste lokalnih zapletov, kot so na primer zapleti po posegih, nekroza rane, izcedek iz rane, slabše celjenje ali vnetje rane.
English: Treatment of partial thickness wounds in adults.
Slovenian: Za zdravljenje ran delne debeline kože pri odraslih.
English: What Episalvan is and what it is used for
Slovenian: Kaj je zdravilo Episalvan in za kaj ga uporabljamo
English: as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), corresponding to 72-88 mg betulin.
Slovenian: ter tudi hibridov obeh vrst (enakovrednega 0,5-1,0 g skorje breze), kar ustreza 72-88 mg betulina.
English: In the Grade 2a burn wound study, the mean wound size treated with Episalvan was 108 cm² (range 23-395 cm²).
Slovenian: Pri študiji ran opeklin stopnje 2a je bila povprečna velikost rane, zdravljene z zdravilom Episalvan, 108 cm² (razpon 23-395 cm²).
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.
Slovenian: Preveliko odmerjanje je pri zdravilu Episalvan malo verjetno: pri bolnikih, pri katerih je velikost rane > 300 cm2 in so bili večkrat zdravljeni z zdravilom Episalvan, v plazmi betulina niso zaznali.
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.
Slovenian: Primaren cilj pri obeh študijah na ranah na mestu odvzema presadka delne debeline kože je bila intraindividualna razlika pri času do zaprtja rane (vsaj 95-odstotna epitelizacija) na podlagi slepih ocen fotografij.
English: Since the systemic exposure of Episalvan following cutaneous application is negligible no interaction with systemic treatments is expected.
Slovenian: Ker je sistemska izpostavljenost zdravilu Episalvan po dermalnem nanosu zanemarljiva, se ne pričakuje medsebojnega delovanja s sistemskimi zdravljenji.
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.
Slovenian: Primaren cilj študije na opeklinah stopnje 2a je bil ugotovitev odstotka bolnikov s prejšnjim celjenjem (najmanj 95-odstotna epitelizacija) na podlagi slepega ocenjevanja fotografij.
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.
Slovenian: Ker pa je količina zdravila Episalvan, ki se absorbira v telo izjemno majhna, se medsebojnega delovanja zdravila Episalvan z drugimi zdravili ne pričakuje.
English: What you need to know before you use Episalvan
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Episalvan
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: The active substance was not genotoxic in in vitro assays.
Slovenian: Zdravilna učinkovina pri preskusih in vitro ni bila genotoksična.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, local tolerance, and phototoxicity.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, lokalnega prenašanja in fototoksičnosti ne kažejo posebnega tveganja za človeka.