FrancophonIA/ELRC3.0 huggingface dataset:
English: In order to further investigate the incidence of treatment area skin malignancy, particularly squamous cell carcinoma, the MAH should conduct and submit the results of a randomised, double-blind, trial in patients treated with ingenol mebutate compared with vehicle control, over at least 18 months of follow-up.
Slovenian: Za nadaljnjo preučitev incidence malignih obolenj kože na zdravljenem predelu, zlasti skvamoznega karcinoma, mora imetnik dovoljenja za promet z zdravilom izvesti randomizirano, dvojno slepo preskušanje pri bolnikih, zdravljenih z ingenolmebutatom, v primerjavi s kontrolno skupino, zdravljeno z vehiklom, z vsaj 18-mesečnim spremljanjem, in predložiti rezultate preskušanja.
English: Within each location the complete and partial clearance rates were higher in the group treated with ingenol mebutate compared to the vehicle group (see table 3 and 4).
Slovenian: Znotraj vsake anatomske lokacije so bile popolne in delne stopnje ozdravitve višje v skupini, zdravljeni z ingenolmebutatom, kot v skupini z vehiklom (glejte preglednici 3 in 4).
English: Fertility No fertility studies have been performed with ingenol mebutate.
Slovenian: Plodnost Študij plodnosti z ingenolmebutatom niso izvedli.
English: Higher mean patient global satisfaction scores, indicating a higher level of overall satisfaction, were seen in the ingenol mebutate groups compared to the vehicle groups (p<0.001) as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM).
Slovenian: Višje povprečne rezultate splošnega zadovoljstva bolnikov, ki nakazujejo na višjo stopnjo splošnega zadovoljstva, so glede na rezultate vprašalnika o zadovoljstvu z zdravljenjem z zdravilom (TSQMTreatment Satisfaction Questionnaire for Medication) dosegali bolniki v skupini z ingenolmebutatom v primerjavi s skupino z vehiklom (p < 0,001).
English: The content of one tube should be used for one treatment area of 25 cm2.
Slovenian: Vsebino ene tube lahko uporabite za zdravljenje enega mesta v velikosti 25 cm2.
English: Recurrence was defined as any identified actinic keratosis lesion in the previously treated area for patients who achieved complete clearance at day 57 in the previous phase 3 studies.
Slovenian: Ponovitev je bila opredeljena kot vsaka lezija aktinične keratoze, zaznana na predhodno zdravljenem mestu, pri bolnikih, ki so 57. dan prejšnjih študij
English: Care should be exercised not to apply the Picato 500 mcg/g gel on the face or scalp as this could lead to a higher incidence of local skin responses.
Slovenian: Paziti je treba, da se na obraz ali lasišče ne nanaša gela Picato z jakostjo 500 µg/g, ker to lahko privede do večje incidence lokalnih odzivov kože.
English: Safety results from the study were comparable to the safety profile of Picato gel, 150 mcg/g as monotherapy
Slovenian: Varnostni rezultati, pridobljeni v tej študiji, so bili primerljivi z varnostnim profilom za gel Picato 150 µg/g pri samostojnem zdravljenju.
English: If treating the hands, only the fingertip which is used for applying the gel should be washed.
Slovenian: Če se zdravi roke, je treba umiti samo prst, s katerim se je nanesel gel.
English: Patients had 4 to 8 clinically typical, visible, discrete, non-hyperkeratotic, non-hypertrophic, actinic keratosis lesions within a contiguous 25 cm2 treatment area on the face or scalp or on the trunk or extremities.
Slovenian: Bolniki so imeli od 4 do 8 klinično tipičnih, vidnih, diskretnih, nehiperkeratotičnih, nehipertrofičnih lezij zaradi aktinične keratoze znotraj sklenjenega območja obraza ali lasišča ali trupa ali okončin, ki je merilo 25 cm2.
English: Patients, in whom a first treatment course did not lead to complete clearance of all AKs in the treatment area after 8 weeks, were randomised to another treatment course with Picato or vehicle.
Slovenian: Bolniki, pri katerih s prvim krogom zdravljenja po 8 tednih niso dosegli popolne ozdravitve vseh aktiničnih keratoz na zdravljenem predelu, so bili randomizirani na dodaten krog zdravljenja z zdravilom Picato ali vehiklom.
English: Infection of the skin in the treatment area can occur (has been reported as a common side effect, which may affect up to 1 in 10 people, when treating the face and scalp).
Slovenian: Lahko se pojavijo okužbe kože na zdravljenem mestu (navedene kot pogost neželeni učinek pri zdravljenju obraza in lasišča, ki se lahko pojavi pri do 1 od 10 bolnikov).
English: Picato contains the active substance ingenol mebutate.
Slovenian: Zdravilo Picato vsebuje učinkovino ingenolmebutat.
English: - Apply the content of one tube to one area of 25 cm2 (e.g. 5 cm x 5 cm).
Slovenian: - Vsebino ene tube nanestite na eno površino velikosti 25 cm2 (npr. 5 cm x 5 cm).
English: Results from two clinical studies on biological effects of ingenol mebutate have shown that topical administration induced epidermal necrosis and a profound inflammatory response in both epidermis and the upper dermis of the treated skin, dominated by infiltrating T cells, neutrophils and macrophages.
Slovenian: Rezultati dveh kliničnih študij o bioloških učinkih ingenolmebutata so pokazali, da je topični nanos povzročil nastanek epidermalne nekroze in znaten vnetni odziv v pokožnici in zgornji usnjici zdravljene kože, pri čemer je prevladovala infiltracija limfocitov T, nevtrofilcev in makrofagov.
English: Patients should wash their hands thoroughly after applying the gel and following any contact with the treated area, to avoid inadvertent transfer of the gel to the eyes.
Slovenian: Bolniki si morajo po nanosu gela in po vsakem stiku z zdravljenim predelom temeljito umiti roke, da preprečijo nenamerni prenos gela z rok ali zdravljenega predela v oči.
English: The most frequently reported adverse reactions are local skin responses including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration at the application site of ingenol mebutate gel, see table 1 for MedDRA terms.
Slovenian: prhljajem/luščenjem, krastami, otekanjem, vezikulacijo/pustulacijo in erozijo/ulceracijo na mestu uporabe gela z ingenolmebutatom; glejte preglednico 1 za izraze po MedDRA.
English: Rare *: Application site swelling on the face or scalp may gravitate to the eye area **: Accidental eye exposure: Post-marketing reports of chemical conjunctivitis and corneal burn in connection with accidental eye exposure have been received (see sections 4.2 and 4.4 for prevention of eye exposure) ***: Including application site burning.
Slovenian: *: Oteklina na mestu nanosa na obrazu ali lasišču se lahko razširi na predel oči **: Nenamerna izpostavljenost oči: po začetku trženja zdravila so poročali o kemično povzročenem vnetju očesne veznice in opeklinah roženice v povezavi z nenamerno izpostavljenostjo oči (glejte poglavji 4.2 in 4.4 o preprečevanju izpostavljenosti oči) ***: Vključno s pekočim občutkom na mestu nanosa.
English: Table 3 Number and percent (95% CI) of subjects achieving complete and partial clearance at day 57 by anatomical location face and scalp
Slovenian: Preglednica 3 Število in odstotek (95-% IZ) oseb, ki so 57. dan dosegli popolno in delno stopnjo ozdravitve glede na anatomske lokacije na obrazu in lasišču
English: If accidental ingestion occurs the patient should drink plenty of water and seek medical care.
Slovenian: Če pride do nenamernega zaužitja, naj bolnik spije veliko vode in poišče zdravniško pomoč.
English: The median percent reduction in actinic keratosis lesions was higher in the group treated with ingenol mebutate compared to the vehicle group (see table 2).
Slovenian: Mediano odstotno zmanjšanje lezij zaradi aktinične keratoze je bilo večje v skupini bolnikov, zdravljenih z ingenolmebutatom, kot v skupini, zdravljeni z vehiklom (glejte preglednico 2).
English: The PRAC also agreed that a DHPC is needed in order to mitigate this risk.
Slovenian: Odbor PRAC se je strinjal tudi, da je za zmanjšanje tveganja potrebno neposredno obvestilo za zdravstvene delavce.
English: Actinic keratosis on the face and scalp in adults
Slovenian: Aktinična keratoza na obrazu in lasišču pri odraslih bolnikih
English: c Patients, in whom the first treatment course did not lead to complete clearance of all AKs in the treatment area.
Slovenian: c Bolniki, pri katerih v prvem ciklu zdravljenja niso dosegli popolne ozdravitve vseh aktiničnih keratoz na zdravljenem predelu.
English: At day 57, patients treated with Picato had higher complete and partial clearance rates than patients treated with vehicle gel (p<0.001).
Slovenian: 57. dan je bil odstotek popolne in delne ozdravitve lezij večji pri bolnikih, zdravljenih z zdravilom Picato, kot pri bolnikih, zdravljenih z gelom z vehiklom (p < 0,001).
English: - This medicine is intended to treat one area of 25 cm2 for three days.
Slovenian: - To zdravilo je namenjeno zdravljenju enega mesta v velikosti 25 cm2 za tri dni.
English: Application site swelling on the face or scalp may gravitate to the eye area.
Slovenian: Oteklina na mestu nanosa na obrazu ali lasišču se lahko razširi na predel oči.
English: - Do not get Picato in your eyes.
Slovenian: - Pazite, da vam zdravilo Picato ne zaide v oči.
English: The efficacy and safety of Picato 150 mcg/g, administered on the face or scalp for 3 consecutive days was studied in two double-blind, vehicle-controlled, clinical studies including 547 adult patients.
Slovenian: Učinkovitost in varnost zdravila Picato 150 µg/g, ki se je 3 zaporedne dni uporabljalo na obrazu ali lasišču, so proučili v dveh dvojno slepih kliničnih študijah, nadzorovanih z vehiklom, ki sta vključili 547 odraslih bolnikov.
English: The incidence of local skin responses that occurred at an incidence >1% in both the ‘face/scalp' and the ‘trunk/extremities', respectively are: application site erythema (94% and 92%), application site exfoliation (85% and 90%), application site scab (80% and 74%), application site swelling (79% and 64%), application site vesicles (13% and 20%), application site pustules (43% and 23%) and application site erosion (31% and 25%).
Slovenian: Opis izbranih neželenih učinkov Lokalni kožni odzivi pri zdravljenju »obraza/lasišča« oziroma »trupa/okončin«, pri katerih je bila incidenca > 1-odstotna, so: eritem na mestu uporabe (94 % oz. 92 %), luščenje kože na mestu uporabe (85 % oz. 90 %), krasta na mestu uporabe (80 % oz. 74 %), oteklina na mestu uporabe (79 % oz. 64 %), vezikule na mestu uporabe (13 % oz. 20 %), pustule na mestu uporabe (43 % oz. 23 %) in erozija mesta uporabe (31 % oz. 25 %).
English: Statistically significant differences in patient reported outcomes were observed in favour of patients receiving Picato compared to those receiving vehicle gel.
Slovenian: Pri izidih, o katerih so poročali bolniki, so opazili statistično pomembne razlike v korist bolnikov,
English: - You should expect to get local skin reactions, such as reddening and swelling, after treatment with this medicine (see section 4).
Slovenian: - Po zdravljenju s tem zdravilom lahko pričakujete lokalne kožne reakcije, kot sta rdečina in otekanje (glejte poglavje 4).
English: Localised skin responses typically resolve within 2 weeks of treatment initiation when treating areas on the face and scalp and within 4 weeks of treatment initiation when treating areas on the trunk and extremities.
Slovenian: Pri zdravljenju obraza in lasišča lokalizirani kožni odzivi običajno izzvenijo v 2 tednih od začetka zdravljenja, pri zdravljenju predelov na trupu in okončinah pa v 4 tednih.
English: The study enrolled patients with 4 to 8 clinically typical, visible, discrete non-hypertrophic and nonhyperkeratotic AK lesions within a 25 cm2 contiguous treatment area.
Slovenian: Študija je vključevala bolnike s 4 do 8 klinično tipičnimi, vidnimi, ločenimi nehipertrofičnimi in nehiperkeratoznimi lezijami zaradi aktinične keratoze na neprekinjenem predelu v velikosti 25 cm2.
English: Table 4 Number and percent (95% CI) of subjects achieving complete and partial clearance at day 57 by anatomical location trunk and extremities
Slovenian: Preglednica 4 Število in odstotek (95-% IZ) preskušancev, ki so 57. dan dosegli popolno in delno stopnjo ozdravitve glede na anatomske lokacije na trupu in okončinah
English: Post-Authorisation safety study:
Slovenian: Študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom:
English: Eye disorders*
Slovenian: Očesne bolezni*
English: Vehicle (n=49)
Slovenian: Vehikel (n = 49)
English: - Treatment of actinic keratosis on the body, arms, hands and legs is one tube of Picato 500 micrograms/g gel (containing 235 micrograms of ingenol mebutate) once a day for 2 days in a row.
Slovenian: - Za zdravljenje aktinične keratoze na telesu, rokah in nogah nanesite eno tubo zdravila Picato 500 mikrogramov/g gel (ki vsebuje 235 mikrogramov ingenolmebutata) enkrat na dan v 2 zaporednih dneh.
English: The non-clinical safety studies demonstrate that cutaneous administration of ingenol mebutate gel is well tolerated with any skin irritation being reversible and a negligible risk of systemic toxicity under the recommended conditions of use.
Slovenian: Predklinične varnostne študije so pokazale, da nanos gela z ingenolmebutatom na kožo bolniki dobro prenašajo in da je vsako draženje kože reverzibilno, tveganje za sistemsko toksičnost pa pri pogojih priporočene uporabe zanemarljivo.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Picato Vsebina pakiranja in dodatne informacije
English: Keratoacanthoma, basal cell carcinoma, Bowen's disease, squamous cell carcinoma Reports of keratoacanthoma, basal cell carcinoma, Bowen's disease, squamous cell carcinoma occurring within the treatment area with a time to onset ranging from weeks to months following use of ingenol mebutate gel have been received from a post-authorisation clinical trial (see section 5.1) and post-marketing.
Slovenian: Keratoakantom, bazalnocelični karcinom, morbus Bowen, skvamozni karcinom V kliničnem preskušanju po pridobitvi dovoljenja za promet in v obdobju trženja so poročali o pojavu keratoakantoma, bazalnoceličnega karcinoma, morbus Bowen, skvamoznega karcinoma na zdravljenem mestu, ki so nastali od nekaj tednov do nekaj mesecev po uporabi gela z ingenolmebutatom (glejte poglavje 5.1).
English: Interactions with systemically absorbed medicinal products are considered unlikely as Picato is not absorbed systemically.
Slovenian: Menijo, da interakcije s sistemsko absorbiranimi zdravili niso verjetne, saj se zdravilo Picato ne absorbira sistemsko.
English: - This medicine is intended to treat one area of 25 cm2 for two days.
Slovenian: - To zdravilo je namenjeno zdravljenju enega mesta v velikosti 25 cm2 za dva dni.
English: In the event of accidental contact, remove the gel by rinsing with plenty of water and seek medical assistance as soon as possible.
Slovenian: Če pride do nenamernega stika z očmi, gel odstranite z izpiranjem z velikimi količinami vode in čim prej poiščite zdravniško pomoč.
English: Table 2 Rates of subjects with complete and partial clearance and median percent (%) lesion reduction in actinic keratosis
Slovenian: Preglednica 2 Delež oseb s popolno in delno ozdravitvijo lezij ter mediano odstotno zmanjšanje
English: Application site pigmentation changes
Slovenian: - sprememba barve kože (pigmentacijska sprememba)
English: Picato should not be applied immediately after taking a shower or less than 2 hours before bedtime.
Slovenian: Zdravila Picato ne nanašajte takoj po prhanju ali manj kot 2 uri pred spanjem.
English: Table 1 Adverse reactions by MedDRA System Organ Classification Frequency
Slovenian: Preglednica 1 Neželeni učinki po organskih sistemih v skladu z MedDRA Pogostnost
English: A repeat treatment course of Picato can be given if an incomplete response is seen at a follow-up examination after 8 weeks or if lesions that are cleared at this examination recur in subsequent examinations.
Slovenian: Če se pri kontrolnem pregledu po 8 tednih ugotovi nepopoln učinek ali če se lezije, ki so ob tem pregledu ozdravljene, ponovijo pri naslednjih kontrolnih pregledih, se lahko uporabi ponoven cikel zdravljenja z zdravilom Picato.
English: No effects on the breastfed newborn/infant are anticipated as Picato is not absorbed systemically.
Slovenian: Učinkov na dojene novorojence/otroke se ne pričakuje, ker se zdravilo Picato ne absorbira sistemsko.
English: One study included patients treated with Picato 150 mcg/g on the face or scalp for 3 days and two studies included patients treated with Picato 500 mcg/g on the trunk or extremities for 2 days.
Slovenian: Ena od študij je vključevala bolnike, ki so bili 3 dni zdravljeni z zdravilom Picato 150 µg/g na obrazu ali lasišču, dve študiji pa sta vključevali bolnike, ki so bili 2 dneva zdravljeni z zdravilom Picato 500 µg/g na trupu ali okončinah.
English: In a later study 450 patients were initially treated with Picato 150 mcg/g, of these 134 patients were randomised to a second treatment course of Picato 150 mcg/g and the patients followed for up to 12 months after the first treatment.
Slovenian: V poznejši študiji so 450 bolnikov najprej zdravili z zdravilom Picato 150 µg/g, nato so 134 od teh bolnikov randomizirali na še en cikel zdravljenja z zdravilom Picato 150 µg/g.
English: b Partial clearance rate was defined as the percentage of patients in whom 75% or more of the number of baseline actinic keratosis lesions were cleared.
Slovenian: b Stopnja delne ozdravitve je bila opredeljena kot odstotek bolnikov, pri katerih je bilo ozdravljenih vsaj 75 %
English: The content of one tube covers a treatment area of 25 cm2 (e.g. 5 cm x 5 cm).
Slovenian: Vsebina tube zadošča za zdravljenje površine 25 cm2 (npr. 5 cm x 5 cm).
English: - Do not wash the areas where you applied the gel for at least 6 hours after you apply it. - Do not touch the treatment area yourself or allow anyone or any pets to touch the treatment area for a period of 6 hours after applying the gel.
Slovenian: - Najmanj 6 ur po nanosu gela se ne dotikajte zdravljenega mesta in ne dovolite, da bi se ga dotikale druge osebe ali živali.
English: Do not apply the 500 mcg/g gel on the face or scalp as this could lead to intense local skin responses.
Slovenian: 500 mikrogramov/g ne nanašajte na obraz ali lasišče, saj lahko povzroči močan lokalni odziv kože.
English: Patients received field treatment (area of 25 cm2) with Picato at concentrations of 150 mcg/g or 500 mcg/g or vehicle once daily for 3 or 2 consecutive days respectively.
Slovenian: Bolniki so enkrat dnevno prejemali lokalno zdravljenje (površine 25 cm2) z zdravilom Picato v koncentraciji 150 µg/g 3 zaporedne dni ali 500 µg/g 2 zaporedna dneva ali lokalno zdravljenje z vehiklom.
English: Actinic Keratosis of the Face and Scalp, sequential use after cryotherapy In a two-arm study, 329 adult patients with AK on the face or scalp were randomised to treatment with Picato gel, 150 mcg/g or vehicle 3 weeks after cryotherapy of all visible lesions in the treatment area.
Slovenian: Aktinična keratoza obraza in lasišča, sekvenčno zdravljenje po krioterapiji V študiji z dvema krakoma so 329 odraslih bolnikov z aktinično keratozo na obrazu in lasišču randomizirali na zdravljenje z gelom Picato 150 µg/g ali vehiklom 3 tedne po krioterapiji vseh vidnih lezij na zdravljenem predelu.
English: Picato 500 micrograms/gram gel is used for actinic keratosis on the body, arms, hands and legs.
Slovenian: Zdravilo Picato 500 mikrogramov/gram gel se uporablja za zdravljenje aktinične keratoze na telesu po rokah in nogah.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ingenol mebutate, the scientific conclusions of CHMP are as follows:
Slovenian: Znanstveni zaključki Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za ingenolmebutat je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Picato 150 micrograms/gram gel is used for actinic keratosis on the face and scalp.
Slovenian: Zdravilo Picato 150 mikrogramov/gram gel se uporablja za zdravljenje aktinične keratoze na obrazu in lasišču.
English: Eye disorders such as eye pain, eyelid oedema and periorbital oedema should be expected to occur after accidental eye exposure of Picato (see section 4.8).
Slovenian: Pričakovati je da se bodo v primeru nenamerne izpostavitve oči zdravilu Picato pojavile težave z očmi, kot so bolečina očesa, edem vek in periorbitalni edem (glejte poglavje 4.8).
English: Table 1 reflects exposure to Picato 150 mcg/g or 500 mcg/g in 499 patients with actinic keratosis treated in four vehicle controlled phase 3 studies enrolling a total of 1,002 patients and post-marketing reports.
Slovenian: V preglednici 1 so zajeti podatki izpostavitev 499 bolnikov z aktinično keratozo zdravilu Picato 150 µg/g ali 500 µg/g v štirih z vehiklom nadzorovanih študijah 3. faze, v katere sta bila skupaj vključena 1002 bolnika, in poročil iz obdobja trženja.
English: Median % Reductionc a Complete clearance rate was defined as the proportion of patients with no (zero) clinically visible actinic keratosis lesions in the treatment area.
Slovenian: Mediano odstotno zmanjšanje (%)c a Stopnja popolne ozdravitve je bila opredeljena kot odstotek bolnikov brez (z nič) klinično vidnih lezij zaradi aktinične keratoze na zdravljenem mestu.
English: c Median percent (%) reduction in actinic keratosis lesions compared to baseline.
Slovenian: c Mediano odstotno zmanjšanje (%) lezij zaradi aktinične keratoze v primerjavi z izhodiščem.
English: On the treatment area: - Tingling or numbness (paraesthesia) - Open sores (ulcer) - Change in skin colour (pigmentation change)
Slovenian: Na zdravljenem mestu: - mravljinčenje ali otrplost (parestezije) - odprte rane (razjede) - sprememba barve kože (pigmentacijska sprememba)
English: - Make sure that your skin has healed from any other treatments or surgery before using this medicine.
Slovenian: - Preden uporabite to zdravilo, se prepričajte, da se je koža po morebitnih prejšnjih oblikah zdravljenja ali kirurških posegih zacelila.
English: Bowen's disease, basal cell carcinoma, keratoacanthoma, malignant melanoma) in patients with actinic keratosis treated with ingenol mebutate, the MAH should conduct and submit the results of a cohort study comparing patients treated with ingenol mebutate with patients exposed to other actinic keratosis treatments.
Slovenian: Za preučitev stopnje malignih obolenj kože (skvamoznega karcinoma, morbus Bowen, bazalnoceličnega karcinoma, keratoakantoma, malignega melanoma) pri bolnikih z aktinično keratozo, zdravljenih z ingenolmebutatom, mora imetnik dovoljenja za promet z zdravilom izvesti kohortno študijo, v kateri bo primerjal bolnike, zdravljene z ingenolmebutatom, in bolnike, izpostavljene drugim zdravilom za zdravljenje aktinične keratoze, ter predložiti rezultate študije.
English: Complete Clearance Ratea
Slovenian: Stopnja popolne ozdravitvea
English: In another study, 329 patients who were initially treated with cryotherapy on the face/scalp were randomised after three weeks to either Picato 150 mcg/g (n=158) or vehicle (n=150) for 3 days in the same area.
Slovenian: V drugi študiji so 329 bolnikov, ki so se najprej zdravili s krioterapijo obraza/lasišča, po 3 tednih randomizirali na 3-dnevno zdravljenje istega predela z zdravilom Picato 150 µg/g (n = 158) ali vehiklom (n = 150).
English: a Complete clearance rate is defined as the proportion of patients with no (zero) clinically visible actinic keratosis lesions in the treatment area.
Slovenian: a Stopnja popolne ozdravitve je opredeljena kot delež bolnikov brez (tj. z nič) klinično vidnih lezij zaradi aktinične keratoze na zdravljenem predelu.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: After using this medicine the skin where you apply it is likely to get red, peel and have scabs.
Slovenian: Po uporabi tega zdravila obstaja verjetnost, da se na mestu nanosa pojavijo rdečina, luščenje ali kraste.
English: - The active substance is ingenol mebutate.
Slovenian: - Učinkovina je ingenolmebutat.