natgillin/translations-raw huggingface dataset:
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. 
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).
Interactions with systemically absorbed medicinal products are considered unlikely as Picato is not absorbed systemically. 
Menijo, da interakcije s sistemsko absorbiranimi zdravili niso verjetne, saj se zdravilo Picato ne absorbira sistemsko.
- This medicine is intended to treat one area of 25 cm2 for two days. 
- To zdravilo je namenjeno zdravljenju enega mesta v velikosti 25 cm2 za dva dni.
In the event of accidental contact, remove the gel by rinsing with plenty of water and seek medical assistance as soon as possible. 
Če pride do nenamernega stika z očmi, gel odstranite z izpiranjem z velikimi količinami vode in čim prej poiščite zdravniško pomoč.
Table 2 Rates of subjects with complete and partial clearance and median percent (%) lesion reduction in actinic keratosis 
Preglednica 2 Delež oseb s popolno in delno ozdravitvijo lezij ter mediano odstotno zmanjšanje
Application site pigmentation changes 
- sprememba barve kože (pigmentacijska sprememba)
Picato should not be applied immediately after taking a shower or less than 2 hours before bedtime. 
Zdravila Picato ne nanašajte takoj po prhanju ali manj kot 2 uri pred spanjem.
Table 1 Adverse reactions by MedDRA System Organ Classification Frequency 
Preglednica 1 Neželeni učinki po organskih sistemih v skladu z MedDRA Pogostnost
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. 
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.
No effects on the breastfed newborn/infant are anticipated as Picato is not absorbed systemically. 
Učinkov na dojene novorojence/otroke se ne pričakuje, ker se zdravilo Picato ne absorbira sistemsko.
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. 
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.
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. 
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.
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. 
b Stopnja delne ozdravitve je bila opredeljena kot odstotek bolnikov, pri katerih je bilo ozdravljenih vsaj 75 %
The content of one tube covers a treatment area of 25 cm2 (e.g. 5 cm x 5 cm). 
Vsebina tube zadošča za zdravljenje površine 25 cm2 (npr. 5 cm x 5 cm).
- 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. 
- Najmanj 6 ur po nanosu gela se ne dotikajte zdravljenega mesta in ne dovolite, da bi se ga dotikale druge osebe ali živali.
Do not apply the 500 mcg/g gel on the face or scalp as this could lead to intense local skin responses. 
500 mikrogramov/g ne nanašajte na obraz ali lasišče, saj lahko povzroči močan lokalni odziv kože.
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. 
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.
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. 
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.
Picato 500 micrograms/gram gel is used for actinic keratosis on the body, arms, hands and legs. 
Zdravilo Picato 500 mikrogramov/gram gel se uporablja za zdravljenje aktinične keratoze na telesu po rokah in nogah.
Taking into account the PRAC Assessment Report on the PSUR(s) for ingenol mebutate, the scientific conclusions of CHMP are as follows: 
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:
Picato 150 micrograms/gram gel is used for actinic keratosis on the face and scalp. 
Zdravilo Picato 150 mikrogramov/gram gel se uporablja za zdravljenje aktinične keratoze na obrazu in lasišču.
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). 
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).
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. 
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.
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. 
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.
c Median percent (%) reduction in actinic keratosis lesions compared to baseline. 
c Mediano odstotno zmanjšanje (%) lezij zaradi aktinične keratoze v primerjavi z izhodiščem.
On the treatment area: - Tingling or numbness (paraesthesia) - Open sores (ulcer) - Change in skin colour (pigmentation change) 
Na zdravljenem mestu: - mravljinčenje ali otrplost (parestezije) - odprte rane (razjede) - sprememba barve kože (pigmentacijska sprememba)
- Make sure that your skin has healed from any other treatments or surgery before using this medicine. 
- Preden uporabite to zdravilo, se prepričajte, da se je koža po morebitnih prejšnjih oblikah zdravljenja ali kirurških posegih zacelila.
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. 
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.
Complete Clearance Ratea 
Stopnja popolne ozdravitvea
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. 
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).
a Complete clearance rate is defined as the proportion of patients with no (zero) clinically visible actinic keratosis lesions in the treatment area. 
a Stopnja popolne ozdravitve je opredeljena kot delež bolnikov brez (tj. z nič) klinično vidnih lezij zaradi aktinične keratoze na zdravljenem predelu.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and genotoxicity. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
After using this medicine the skin where you apply it is likely to get red, peel and have scabs. 
Po uporabi tega zdravila obstaja verjetnost, da se na mestu nanosa pojavijo rdečina, luščenje ali kraste.
- The active substance is ingenol mebutate. 
- Učinkovina je ingenolmebutat.
Local skin responses such as erythema, flaking/scaling, and crusting should be expected to occur after cutaneous application of Picato (see section 4.8). 
Pričakuje se, da se bodo po nanosu zdravila Picato na koži pojavili lokalni odzivi, kot so eritem, prhljaj/luščenje in nastajanje krast (glejte poglavje 4.8).
Picato 500 micrograms/gram gel 
Picato 500 mikrogramov/gram gel
The incidence of severe local skin responses that occurred at an incidence >1% in both the ‘face/scalp' and the ‘trunk/extremities', respectively are: application site erythema (24% and 15%), application site exfoliation (9% and 8%), application site scab (6% and 4%), application site swelling (5% and 3%) and application site pustules (5% and 1%). 
Hudi lokalni odzivi na koži pri zdravljenju »obraza/lasišča« oziroma »trupa/okončin«, pri katerih je bila incidenca > 1-odstotna, so: eritem na mestu uporabe (24 % oz. 15 %), luščenje kože na mestu uporabe (9 % oz. 8 %), krasta na mestu uporabe (6 % oz. 4 %), oteklina mesta uporabe (5 % oz. 3 %) in pustule na mestu uporabe (5 % oz. 1 %).
In a double-blind, vehicle-controlled study to evaluate systemic exposure, Picato 500 mcg/g, from 4 tubes, was applied to a 100 cm2 contiguous treatment area daily for 2 consecutive days. 
V dvojno slepi, z vehiklom nadzorovani študiji za ocenitev sistemske izpostavljenosti so zdravilo Picato 500 µg/g iz 4 tub 2 zaporedna dneva nanašali na sklenjeno zdravljeno mesto velikosti 100 cm2.
Risks to humans receiving cutaneous treatment with ingenol mebutate are considered unlikely as Picato is not absorbed systemically. 
Tveganja za ljudi, ki prejemajo kožno zdravljenje z ingenolmebutatom, so malo verjetna, saj se zdravilo Picato ne absorbira sistemsko.
Rare side effects, may affect up to 1 in 1000 people: 
Redki neželeni učinki se lahko pojavijo pri največ 1 od 1.000 bolnikov:
On the treatment area: - Scarring 
Na zdravljenem mestu: - brazgotinjenje
Nervous system disorders 
Bolezni živčevja glavobol pogosti
Cutaneous use 
Dermalna uporaba
Patients in whom the first treatment course led to complete clearance were seen at 26 and 44 weeks and randomised to a second treatment course if they had a recurrence in the field. 
Bolnike, pri katerih so s prvim krogom zdravljenja dosegli popolno ozdravitev, so ponovno pregledali v 26. in 44. tednu ter jih randomizirali na dodaten krog zdravljenja,
SCC in the treatment area was reported in no patients (0 of 184 patients previously treated with ingenol mebutate gel) in the three prospective, observational long term 1 year follow-up studies. 
V treh prospektivnih, opazovalnih dolgotrajnih študijah z 1-letnim spremljanjem niso pri nobenem od bolnikov opazili skvamoznega karcinoma (0 od 184 bolnikov, predhodno zdravljenih z gelom z ingenolmebutatom).
Administration of Picato is not recommended until the skin is healed from treatment with any previous medicinal product or surgical treatment and should not be applied to open wounds or damaged skin where the skin barrier is compromised. 
Nanašanje gela Picato se ne priporoča, dokler koža, zdravljena s predhodnimi zdravili ali kirurško, ni zaceljena.
Package leaflet: Information for the patient Picato 500 micrograms/gram gel ingenol mebutate This medicine is subject to additional monitoring. 
Navodilo za uporabo Picato 500 mikrogramov/gram gel ingenolmebutat (ingenoli mebutas) Za to zdravilo se izvaja dodatno spremljanje varnosti.
If more than half of the treatment area is located in the lower part of the neck, Picato 500 mcg/g gel should be used at the posology for trunk and extremities. 
Če je več kot polovica zdravljenega mesta na spodnjem delu vratu, je treba uporabiti gel Picato 500 µg/g v odmerku za trup in okončine.
d Patients in whom the first treatment course did lead to complete clearance and who had a recurrence in the treatment area at either week 26 or 44. 
d Bolniki, pri katerih so v prvem krogu zdravljenja dosegli popolno ozdravitev, vendar so v 26. ali 44. tednu ugotovili ponovitev bolezni.
Package leaflet: Information for the patient Picato 150 micrograms/gram gel ingenol mebutate This medicine is subject to additional monitoring. 
Navodilo za uporabo Picato 150 mikrogramov/gram gel ingenolmebutat (ingenoli mebutas) Za to zdravilo se izvaja dodatno spremljanje varnosti.
Uncommon side effects, may affect up to 1 in 100 people: 
Občasni neželeni učinki se lahko pojavijo pri največ 1 od 100 bolnikov:
Patients continued in the studies for an 8 week follow-up period during which they returned for clinical observations and safety monitoring. 
tedenskim spremljanjem, med katerim so bili klinično opazovani, in spremljani glede varnosti.
Patients should be instructed to wash their hands with soap and water, immediately after applying Picato, and between topical applications if two different areas require different strengths. 
Bolnikom naročite, naj si po nanosu zdravila Picato in med lokalnimi nanosi, če je treba na dveh različnih mestih uporabiti različne jakosti gela, nemudoma umijejo roke z milom in vodo.
This side effect is uncommon. 
Ta neželeni učinek se pojavlja občasno.
Picato 150 micrograms/gram gel 
Picato 150 mikrogramov/gram gel
Other side effects: - Swelling of the area around the eye (periorbital oedema) - Swelling (oedema) of your eye lid - Headache 
Drugi neželeni učinki: - otekline v predelu okoli oči (periorbitalni edem) - otekanje (edem) očesnih vek
Safety of Picato 150 mcg/g treatment for 3 days or Picato 500 mcg/g treatment for 2 days was assessed up to day 57, the majority of the reported adverse reactions and local skin responses were mild to moderate in intensity and all resolved without sequelae. 
Picato 500 µg/g so proučevali 57 dni, pri čemer je bilo ugotovljeno, da je večina poročanih neželenih učinkov in lokalnih reakcij na koži blage ali zmerne intenzivnosti ter, da so izzveneli brez posledic.
- Do not cover the treated area with air- or water-tight bandages after you have applied this medicine. 
- Zdravljenega mesta, na katerega ste nanesli to zdravilo, ne prekrivajte z obliži, neprepustnimi za zrak ali vodo.
Vehicle (n=20) 
Vehikel (n = 20)
In a double-blind, vehicle-controlled study in patients with AK on trunk and extremities, an investigational product with ingenol mebutate gel 600 mcg/g was applied once daily for 2, 3, or 4 days to a skin area of 250 cm2. 
V dvojno slepi, z vehiklom nadzorovani študiji, so pri bolnikih z aktinično keratozo na trupu in okončinah preiskovano zdravilo, gel z ingenolmebutatom 600 µg/g, nanašali 2, 3 ali 4 dni na predel kože velikosti 250 cm2.
One tube of Picato 150 mcg/g gel (containing 70 mcg ingenol mebutate) should be applied once daily to the affected area for 3 consecutive days. 
Eno tubo zdravila Picato 150 µg/g gel (ki vsebuje 70 µg ingenolmebutata) je treba enkrat dnevno nanesti na prizadeti predel in postopek ponavljati 3 zaporedne dni.
If you are treating your hands you should only wash the fingertip which you used for applying the gel. 
Če izvajate zdravljenje na rokah, umijte samo blazinico prsta, s katerim ste nanašali gel.
If you are breast-feeding, avoid physical contact between the baby and the treated area for 6 hours after application of this medicine. 
Če dojite, 6 ur po nanosu tega zdravila preprečite telesni stik dojenčka z mestom zdravljenja.
Other side effects: - Eye pain - Injury or irritation to the surface of the eye (cornea, conjunctiva) following accidental exposure 
Drugi neželeni učinki: - bolečina v očesu - poškodba ali draženje površine očesa (roženice, veznice) po nenamerni izpostavljenosti
Drink plenty of water if you accidentally swallow this medicine and seek medical assistance. 
Ob nenamernem zaužitju pijte veliko vode in poiščite zdravniško pomoč.
Complete Clearance 
Popolna ozdravitev
Talk to your doctor or pharmacist before using Picato. 
Pred začetkom uporabe zdravila Picato se posvetujte z zdravnikom ali farmacevtom.
Picato 500 micrograms/g gel ingenol mebutate 
Picato 500 mikrogramov/g gel ingenoli mebutas
Vehicle (n=270) 
Vehikel (n = 270)
Vehicle (n=232 ) 
Vehikel (n = 232)
Picato 150 mcg/g gel is available in a carton containing 3 tubes with 0.47 g of gel each. 
Zdravilo Picato 150 µg/g gel je pakirano v škatli s 3 tubami, od katerih vsaka vsebuje 0,47 g gela.
Picato 150 mcg/g (n=277 ) 
Zdravilo Picato 150 µg/g (n = 277)
In a double blind, vehicle-controlled study, up to two treatment courses of Picato 150 mcg/g were administered to 450 patients with 4-8 AKs in a 25 cm2 treatment area on the face or scalp. 
V dvojno slepi, z vehiklom nadzorovani študiji je 450 bolnikov s 4-8 aktiničnimi keratozami na predelu obraza in lasišča v velikosti 25 cm2 prejelo do dva cikla zdravljenja z zdravilom Picato 150 µg/g.
Picato 150 micrograms/g gel ingenol mebutate 
Picato 150 mikrogramov/g gel ingenoli mebutas
Picato 500 mcg/g (n=226 ) 
Zdravilo Picato 500 µg/g (n = 226)
Long-term follow up 
Dolgotrajno sledenje
Picato 500 mcg/g gel is available in a carton containing 2 tubes with 0.47 g of gel each. 
Zdravilo Picato 500 µg/g gel je pakirano v škatli z 2 tubama, od katerih vsaka vsebuje 0,47 g gela.
ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S) 
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO
Scientific conclusions 
KLINIČNI PODATKI
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 500 mcg/g GEL 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA S TUBAMI 500 mikrogramov/g GEL
On the treatment area: - Itching (pruritus) - Irritation 
Na zdravljenem mestu: - srbenje (pruritus) - draženje
- Warmth 
- draženje
Picato 150 mcg/g gel (n= 92) 
Picato 150 µg/g gel (n = 92)
On the treatment area: - Tingling or numbness (paraesthesia) - Open sores (ulcer) - Discharge (secretion) of fluid - Change in skin colour (pigmentation change) 
- odprte rane (razjede) - izloček (sekrecija) - sprememba barve kože (pigmentacijska sprememba)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 150 mcg/g GEL 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA S TUBAMI 150 mikrogramov/g GEL
Likewise the efficacy and safety of Picato 500 mcg/g, administered on the trunk and extremities for 2 consecutive days was studied in two double-blind, vehicle-controlled, clinical studies including 458 adult patients. 
Tudi učinkovitost in varnost zdravila Picato 500 µg/g, ki se je 2 zaporedna dneva uporabljalo na trupu ali okončinah, so proučili v dveh dvojno slepih kliničnih študijah,
Trunk and extremities 
Trup in okončine
Avoid touching the treatment area for 6 hours after applying your medicine. 
6 ur po nanosu zdravila se ne dotikajte zdravljenega mesta, na katerega ste nanesli zdravilo.
Wash your hands again if you happen to touch the area where you applied the gel. 
Če se za tem dotaknete predela, na katerega ste nanesli gel, si znova umijte roke.
Other possible side effects when treating the trunk and extremities: Common side effects, may affect up to 1 in 10 people: 
Drugi možni neželeni učinki ob zdravljenju trupa in okončin: Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov:
Wash your hands thoroughly after you have applied the gel. 
Po nanašnju gela si temeljito umijte roke.
On the treatment area: - Some of the outer layer of your skin may wear away (erosion) - Blisters (vesicles, pustules) - Peeling (exfoliation) - Scabs - Redness due to widening of the small blood vessels (erythema) 
Na zdravljenem mestu: - lahko se odlušči del vrhnje plasti kože (erozija) - mehurji (vezikule in pustule)
Headache 
- glavobol
- Gently rub the gel onto the treatment area. 
- Gel nežno vtrite v prizadeto mesto.
Infection at the application site has been reported when treating face and scalp. 
Pri zdravljenju obraza in lasišča so poročali o okužbi na mestu nanosa.
Each tube contains 235 micrograms of ingenol mebutate in 0.47 g of gel. 
Vsaka tuba vsebuje 235 mikrogramov ingenolmebutata v 0,47 g gela.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Picato 150 mcg/g gel (n=42) 
Picato 150 µg/g gel (n = 42)
Picato 500 mcg/g was well tolerated when applied to a contiguous treatment area of 100 cm2 on the trunk and extremities. 
Zdravilo Picato 500 µg/g so bolniki pri nanosu na sklenjeno prizadeto mesto velikosti 100 cm2 na trupu in okončinah dobro prenašali.
Name and address of the manufacturer responsible for batch release LEO Laboratories Ltd. 
Ime in naslov izdelovalca, odgovornega za sproščanje serij
These side effects most often occur within one day after applying this medicine. 
Ti neželeni učinki se navadno pojavijo 1. dan po nanosu zdravila.
Each tube contains 70 micrograms of ingenol mebutate in 0.47 g of gel. 
Vsaka tuba vsebuje 70 mikrogramov ingenolmebutata v 0,47 g gela.
Application site erosion 
Stopnja delne ozdravitveb
Other possible side effects when treating the face and scalp: Common side effects, may affect up to 1 in 10 people: 
Drugi možni neželeni učinki ob zdravljenju na obrazu in lasišču: Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov:
Posology 
Obraz
Lesion Based Recurrence Rateb 12 months 
Stopnja ponovitve pri 12 mesecih ocena KM (95-odstotni IZ)a Stopnja ponovitve lezijb 12 mesecev
Each tube contains 70 mcg of ingenol mebutate in 0.47 g of gel. 
Vsaka tuba vsebuje 70 µg ingenolmebutata (ingenoli mebutas) v 0,47 g gela.
Each gram of gel contains 150 micrograms of ingenol mebutate. 
En gram gela vsebuje 150 mikrogramov ingenolmebutata.
Each gram of gel contains 500 micrograms of ingenol mebutate. 
En gram gela vsebuje 500 mikrogramov ingenolmebutata.
Each tube contains 235 mcg of ingenol mebutate in 0.47 g of gel. 
Vsaka tuba vsebuje 235 µg ingenolmebutata (ingenoli mebutas) v 0,47 g gela.
Please contact your doctor or pharmacist if you forget to use Picato. 
Če ste pozabili uporabiti zdravilo Picato Če ste pozabili uporabiti zdravilo Picato, se posvetujte s svojim zdravnikom ali farmacevtom.
LIST OF EXCIPIENTS 
- izloček (sekrecija)