FrancophonIA/ELRC3.0 huggingface dataset:
English: 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%).
Croatian: Teške lokalne kožne reakcije koje su se pojavile pri incidenciji od >1% na “licu/vlasištu”, odnosno na “trupu/udovima” bile su: eritem na mjestu primjene (24% i 15%), ljuštenje na mjestu primjene (9% i 8%), krasta na mjestu primjene (6% i 4%), oticanje na mjestu primjene (5% i 3%) i gnojni mjehurići na mjestu primjene (5% i 1%).
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.
Croatian: Tablica s popisom nuspojava Tablica 1 odražava izloženost lijeku Picato 150 µg/g ili 500 µg/g kod 499 bolesnika s aktiničkom keratozom u četiri podlogom kontrolirana ispitivanja faze 3 u koje su bila uključena ukupno 1002 bolesnika i izvješća nakon odobrenja za stavljanje lijeka u promet.
English: This side effect is uncommon.
Croatian: Ta je nuspojava manje česta.
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.
Croatian: Jedno ispitivanje uključivalo je bolesnike liječene lijekom Picato 150 µg/g na licu ili vlasištu tijekom 3 dana, a dva su ispitivanja uključivala bolesnike liječene lijekom Picato 500 µg/g na trupu ili udovima tijekom 2 dana.
English: 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.
Croatian: U dvostruko slijepom ispitivanju kontroliranom podlogom, primijenjeno je do dva ciklusa liječenja lijekom Picato 150 µg/g u 450 bolesnika sa 4-8 aktiničkih keratoza u liječenom području od 25 cm2 na licu i vlasištu.
English: Vehicle (n=49)
Croatian: Podloga (n=49)
English: Application site pain***
Croatian: Bol na mjestu primjene***
English: If treating the hands, only the fingertip which is used for applying the gel should be washed.
Croatian: Ako se liječe ruke, potrebno je oprati samo vrh prsta kojim se nanosi gel.
English: The PRAC also agreed that a DHPC is needed in order to mitigate this risk.
Croatian: PRAC je također suglasan kako je za minimizaciju ovog rizika potrebno uputiti i pismo zdravstvenim radnicima.
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.
Croatian: **: Slučajna izloženost oka: nakon odobrenja za stavljanje lijeka u promet primljena su izvješća o kemijskom konjunktivitisu i opeklinama rožnice povezanima sa slučajnom izloženosti oka (vidjeti dijelove 4.2 i 4.4 za prevenciju izloženosti oka)
English: Local skin responses such as erythema, flaking/scaling, and crusting should be expected to occur after cutaneous application of Picato (see section 4.8).
Croatian: Treba očekivati pojavu lokalnih kožnih reakcija kao što su eritem, ljuskanje/ljuštenje i krastanje nakon nanošenja lijeka Picato na kožu (vidjeti dio 4.8).
English: - Apply the content of one tube to one area of 25 cm2 (e.g. 5 cm x 5 cm).
Croatian: - Nanesite sadržaj jedne tube na jednu površinu od 25 cm2 (npr. 5 cm x 5 cm).
English: Interactions with systemically absorbed medicinal products are considered unlikely as Picato is not absorbed systemically.
Croatian: Interakcije s lijekovima koji se sistemski apsorbiraju smatraju se malo vjerojatnima budući da se Picato ne apsorbira sistemski.
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.
Croatian: Bolesnici su primali lokalnu terapiju (područje od 25 cm2) lijekom Picato u koncentraciji od 150 µg/g ili 500 µg/g ili podlogu jedanput na dan tijekom 3 ili 2 uzastopna dana.
English: Periorbital oedema
Croatian: Periorbitalni edem
English: Picato 500 mcg/g was well tolerated when applied to a contiguous treatment area of 100 cm2 on the trunk and extremities.
Croatian: Picato 500 µg/g dobro se podnosio pri primjeni na okolno liječeno područje od 100 cm2 na trupu i udovima.
English: Application site erosion
Croatian: Erozija na mjestu primjene
English: Table 4 Number and percent (95% CI) of subjects achieving complete and partial clearance at day 57 by anatomical location trunk and extremities
Croatian: Tablica 4 Broj i postotak (95%-tni CI) ispitanika koji su ostvarili potpuni i djelomični nestanak lezija u 57. danu prema anatomskoj lokaciji trupa i udova
English: Risks to humans receiving cutaneous treatment with ingenol mebutate are considered unlikely as Picato is not absorbed systemically.
Croatian: Rizici za ljude koji primaju kožnu terapiju ingenol mebutatom smatraju se malo vjerojatnima budući da se Picato ne apsorbira sistemski.
English: Minor fetal abnormalities or variants were observed in the fetuses of treated dams at doses of 1 mcg/kg/day (12 mcg/m2/day).
Croatian: Manje abnormalnosti fetusa ili odstupanja primijećeni su kod fetusa ženki liječenih dozama od 1 µg/kg/dan (12 µg/m2/dan).
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.
Croatian: Medijan % smanjenjac a Stopa potpunog nestanka definirana je kao udio bolesnika s nijednom (nula) klinički vidljivom lezijom aktiničke keratoze u liječenom području.
English: Do not apply the 500 mcg/g gel on the face or scalp as this could lead to intense local skin responses.
Croatian: 500 mikrograma/g na licu ili vlasištu jer bi to moglo dovesti do jakih lokalnih kožnih reakcija.
English: PHARMA-COS LTD Tel: +356 2144 1870
Croatian: LTD Tel: +356 2144 1870
English: If you are breast-feeding, avoid physical contact between the baby and the treated area for 6 hours after application of this medicine.
Croatian: Ako dojite, izbjegavajte fizički doticaj djeteta s liječenim područjem tijekom 6 sati nakon nanošenja ovog lijeka.
English: - Treatment of actinic keratosis on the face and scalp is one tube of Picato 150 micrograms/g gel (containing 70 micrograms of ingenol mebutate) once a day for 3 days in a row.
Croatian: Za liječenje aktiničke keratoze na licu i vlasištu nanosite jednu tubu Picato 150 mikrograma/g gela (koji sadrži 70 mikrograma ingenol mebutata) jedanput na dan 3 dana zaredom.
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.
Croatian: Ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet: radi dodatnog istraživanja incidencije maligniteta kože na liječenom području, osobito karcinoma pločastih stanica, nositelj odobrenja mora provesti randomizirano, dvostruko slijepo ispitivanje u bolesnika liječenih ingenol mebutatom u usporedbi s podlogom kao kontrolom, tijekom najmanje 18 mjeseci praćenja, te dostaviti rezultate navedenog ispitivanja.
English: Other side effects: - Injury or irritation to the surface of the eye (cornea, conjunctiva) following accidental exposure
Croatian: Druge nuspojave: - Ozljeda ili iritacija površine oka (rožnice, spojnice) nakon slučajne izloženosti
English: 149 patients in the Picato group and 140 in the vehicle group were followed for 12 months.
Croatian: 140 u skupini podloge praćeno je tijekom 12 mjeseci.
English: Picato 500 micrograms/gram gel
Croatian: Picato 500 mikrograma/gram gel
English: Vehicle (n=20)
Croatian: Podloga (n=20)
English: a Complete clearance rate is defined as the proportion of patients with no (zero) clinically visible actinic keratosis lesions in the treatment area.
Croatian: a Stopa potpunog nestanka definirana je kao udio bolesnika s nijednom (nula) klinički vidljivom lezijom aktiničke keratoze u liječenom području.
English: Drink plenty of water if you accidentally swallow this medicine and seek medical assistance.
Croatian: Ako slučajno progutate ovaj lijek, popijte mnogo vode i potražite liječničku pomoć.
English: 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.
Croatian: Jednu tubu Picato 150 µg/g gela (koja sadrži 70 µg ingenol mebutata) treba nanijeti jedanput dnevno na zahvaćeno područje tijekom 3 uzastopna dana.
English: Complete Clearance Ratea
Croatian: Stopa potpunog nestankaa
English: In the event of accidental contact, remove the gel by rinsing with plenty of water and seek medical assistance as soon as possible.
Croatian: Ako dođe do slučajnog doticaja s očima, uklonite gel ispirući ga velikim količinama vode i što prije potražite liječničku pomoć.
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.
Croatian: Keratoakantom, karcinom bazalnih stanica, Bowenova bolest, karcinom pločastih stanica Iz kliničkog ispitivanja provedenog nakon davanja odobrenja za stavljanje lijeka u promet te u razdoblju nakon stavljanja lijeka u promet zaprimljena su izvješća o pojavi keratoakantoma, karcinoma bazalnih stanica, Bowenove bolesti i karcinoma pločastih stanica na liječenom području, s vremenom do pojavljivanja u rasponu od nekoliko tjedana do nekoliko mjeseci nakon primjene ingenol mebutat gela (vidjeti dio 5.1).
English: - Do not get Picato in your eyes.
Croatian: - Pripazite da Vam lijek Picato ne dođe u oči.
English: Uncommon side effects, may affect up to 1 in 100 people:
Croatian: Manje česte nuspojave, mogu zahvatiti do 1 na 100 osoba:
English: Vehicle (n=232 )
Croatian: Podloga (n=232)
English: Table 2 Rates of subjects with complete and partial clearance and median percent (%) lesion reduction in actinic keratosis
Croatian: Tablica 2 Stope potpunog i djelomičnog nestanka kod ispitanika i medijan postotka (%)
English: Vehicle (n=270)
Croatian: Podloga (n=270)
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.
Croatian: U ispitivanju s dvije skupine bolesnika, 329 odraslih bolesnika s aktiničkom keratozom na licu ili vlasištu bilo je randomizirano za liječenje lijekom Picato gel, 150 µg/g ili podlogom 3 tjedna nakon krioterapije svih vidljivih lezija na liječenom području.
English: Picato 150 micrograms/gram gel
Croatian: Picato 150 mikrograma/gram gel
English: 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.
Croatian: U dvostruko slijepom, podlogom kontroliranom ispitivanju radi procjene sistemske izloženosti, Picato 500 µg/g iz 4 tube svaki se dan nanosio na okolno liječeno područje od 100 cm2 tijekom 2 uzastopna dana.
English: Face Scalp
Croatian: - Ožiljak
English: Complete clearance
Croatian: Potpuni nestanak
English: Picato 150 mcg/g (n=277)
Croatian: Picato 150 µg/g (n=277)
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.
Croatian: Nemojte sami dirati liječeno područje ni dopustiti nekom drugom ili kućnim ljubimcima da diraju liječeno područje tijekom razdoblja od 6 sati nakon nanošenja gela.
English: LEO Pharma s.r.o.
Croatian: LEO Pharma B.V.
English: Picato 500 mcg/g (n=226 )
Croatian: Picato 500 µg/g (n=226)
English: Wash your hands again if you happen to touch the area where you applied the gel.
Croatian: Ako slučajno dodirnete područje na koje ste nanijeli gel, ponovo operite ruke.
English: Application site ulcer
Croatian: Ulkus na mjestu primjene
English: For single use only Read the package leaflet before use.
Croatian: Prije uporabe pročitajte uputu o lijeku.
English: If you are treating your hands you should only wash the fingertip which you used for applying the gel.
Croatian: Ako liječite ruke, operite samo vrh prsta kojim ste nanijeli gel.
English: Arm
Croatian: Ruka
English: Picato 500 micrograms/g gel ingenol mebutate
Croatian: Picato 500 mikrograma/g gel ingenoli mebutas
English: Picato 500 micrograms/g gel is clear and colourless and each carton contains 2 tubes with 0.47 g of gel each.
Croatian: Picato 500 mikrograma/g gel je bistar i bezbojan, a svako kartonsko pakiranje sadrži 2 tube od kojih svaka sadrži 0,47 g gela.
English: Picato 150 micrograms/g gel is clear and colourless and each carton contains 3 tubes with 0.47 g of gel each.
Croatian: Picato 150 mikrograma/g gel je bistar i bezbojan, a svako kartonsko pakiranje sadrži 3 tube od kojih svaka sadrži 0,47 g gela.
English: 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.
Croatian: bolesnika prethodno liječenih ingenol mebutat gelom) u tri prospektivna, opservacijska dugoročna jednogodišnja kontrolna ispitivanja.
English: Other side effects: - Swelling of the area around the eye (periorbital oedema) - Swelling (oedema) of your eye lid - Headache
Croatian: - Oticanje područja oko oka (periorbitalni edem) - Oticanje (edem) očnog kapka
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 150 mcg/g GEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA OD 150 µg/g GELA
English: - 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) - Pain (including application site burning)
Croatian: - Ljuštenje (eksfolijacija) - Kraste - Crvenilo zbog proširenja malih krvnih žila (eritem) - Bol (uključujući žarenje na mjestu primjene)
English: On the treatment area: - Itching (pruritus) - Irritation
Croatian: - Svrbež (pruritus) - Iritacija
English: Application site irritation
Croatian: Iritacija na mjestu primjene
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.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet: radi ispitivanja stope maligniteta kože (karcinom pločastih stanica, Bowenova bolest, karcinom bazalnih stanica, keratoakantom, maligni melanom) u bolesnika s aktiničkom keratozom liječenom ingenol mebutatom, nositelj odobrenja mora provesti kohortno ispitivanje u kojem se uspoređuju bolesnici liječeni ingenol mebutatom i bolesnici izloženi drugim terapijama aktiničke keratoze, te dostaviti rezultate navedenog ispitivanja.
English: If more than half of the treatment area is located in the upper part of the neck, Picato 150 mcg/g gel should be used at the posology for face and scalp.
Croatian: Ako se više od polovice liječenog područja nalazi na gornjem dijelu vrata, treba primijeniti Picato 150 µg/g gel u dozi za lice i vlasište.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 500 mcg/g GEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA OD 500 µg/g GELA
English: - Be vigilant for any new scaly red patches, open sores, elevated or warty growths within the treatment area.
Croatian: - Pratite pojavljuju li se na liječenom području nova ljuskasta crvena mjesta, otvorene rane,
English: You should avoid the use of Picato if you are pregnant.
Croatian: Picato ako ste trudni.
English: - Wash your hands with soap and water immediately after applying the gel, and also in between administrations if prescribed two different strengths for two different areas.
Croatian: - Operite ruke sapunom i vodom neposredno nakon nanošenja gela te između nanošenja ako su
English: The most frequently occurring side effects when treating the face and scalp: Very common side effects on the treatment area, may affect more than 1 in 10 people:
Croatian: Najčešće nuspojave koje se javljaju pri liječenju lica i vlasišta: Vrlo česte nuspojave na liječenom području, mogu zahvatiti više od 1 na 10 osoba: Na liječenom području:
English: Picato 150 micrograms/g gel ingenol mebutate
Croatian: Picato 150 mikrograma/g gel ingenoli mebutas
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.
Croatian: U drugom ispitivanju, 329 bolesnika koji su u početku liječeni krioterapijom na licu ili vlasištu randomizirani su nakon tri tjedna na Picato 150 µg/g
English: Name and address of the manufacturer responsible for batch release LEO Laboratories Ltd.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: In rats, ingenol mebutate was not associated with fetal developmental effects at IV doses up to 5 mcg/kg/day (30 mcg/m2/day).
Croatian: U štakora ingenol mebutat nije bio povezan s učincima na razvoj fetusa pri i.v. primjeni doze do
English: The most frequently occurring side effects when treating the trunk and extremities: Very common side effects on the treatment area, may affect more than 1 in 10 people:
Croatian: Najčešće nuspojave koje se javljaju pri liječenju trupa i udova: Vrlo česte nuspojave na liječenom području, mogu zahvatiti više od 1 na 10 osoba: Na liječenom području:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TUBE 150 mcg/g GEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TUBA SA 150 µg/g GELA
English: Lesion Based Recurrence Rateb 12 months
Croatian: Stopa povrata za pojedinačne lezijeb 12 mjeseci Aritmetička sredina (SD)
English: 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.
Croatian: Ako se više od polovice liječenog područja nalazi na donjem dijelu vrata, treba primijeniti Picato 500 µg/g gel u dozi za trup i udove.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TUBE 500 mcg/g GEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TUBA SA 500 µg/g GELA
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).
Croatian: Viša aritmetička sredina rezultata općeg zadovoljstva bolesnika, koja upućuje na višu razinu ukupnog zadovoljstva, uočena je u skupinama koje su primale ingenol mebutat u usporedbi sa skupinama koje su primale podlogu
English: 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.
Croatian: Isto tako, djelotvornost i sigurnost lijeka Picato 500 µg/g, primjenjivanog na trupu i udovima tijekom 2 uzastopna dana ispitivane su u dva dvostruko slijepa,
English: Picato 150 mcg/g gel (n= 92)
Croatian: Picato 150 µg/g gel (n=92)
English: Picato 150 mcg/g gel is available in a carton containing 3 tubes with 0.47 g of gel each.
Croatian: Picato 150 µg/g gel dostupan je u kartonskom pakiranju s 3 tube od kojih svaka sadrži 0,47 g gela.
English: Picato 500 mcg/g gel is available in a carton containing 2 tubes with 0.47 g of gel each.
Croatian: Picato 500 µg/g gel dostupan je u kartonskom pakiranju s 2 tube od kojih svaka sadrži 0,47 g gela.
English: Other possible side effects when treating the face and scalp: Common side effects, may affect up to 1 in 10 people:
Croatian: Druge moguće nuspojave koje se javljaju pri liječenju lica i vlasišta: Česte nuspojave, mogu zahvatiti do 1 na 10 osoba: Na liječenom području:
English: KM estimate (95% CI)a
Croatian: Stopa povrata 12 mjeseci Kaplan-Meierova (KM) procjena (95%-tni CI)a
English: If more than half of the treatment area is located in the upper part of the neck: - Use Picato 150 mcg/g gel (face and scalp) If more than half of the treatment area is located in the lower part of the neck: - Use Picato 500 mcg/g gel (trunk and extremities)
Croatian: Ako se više od polovice liječenog područja nalazi u donjem dijelu vrata: - primijenite Picato 500 mikrograma/g gel (trup i udovi)
English: Each tube contains 235 micrograms of ingenol mebutate in 0.47 g of gel.
Croatian: Svaka tuba sadrži 235 mikrograma ingenol mebutata u 0,47 g gela.
English: 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.
Croatian: U dvostruko slijepom, podlogom kontroliranom ispitivanju kod bolesnika s aktiničkom keratozom na trupu i udovima, ispitivani lijek s gelom ingenol mebutata 600 µg/g primijenjen je jednom dnevno 2,
English: Each tube contains 70 micrograms of ingenol mebutate in 0.47 g of gel.
Croatian: Svaka tuba sadrži 70 mikrograma ingenol mebutata u 0,47 g gela.
English: Each gram of gel contains 150 micrograms of ingenol mebutate.
Croatian: Jedan gram gela sadrži 150 mikrograma ingenol mebutata.
English: Other possible side effects when treating the trunk and extremities: Common side effects, may affect up to 1 in 10 people:
Croatian: Druge moguće nuspojave koje se javljaju pri liječenju trupa i udova: Česte nuspojave, mogu zahvatiti do 1 na 10 osoba: Na liječenom području:
English: Each gram of gel contains 500 micrograms of ingenol mebutate.
Croatian: Jedan gram gela sadrži 500 mikrograma ingenol mebutata.
English: Actinic keratosis on the trunk and extremities in adults One tube of Picato 500 mcg/g gel (containing 235 mcg ingenol mebutate) should be applied once daily to the affected area for 2 consecutive days.
Croatian: Jednu tubu Picato 500 µg/g gela (koja sadrži 235 µg ingenol mebutata) treba nanijeti jedanput dnevno na zahvaćeno područje tijekom 2 uzastopna dana.
English: Application site pustules
Croatian: Pustule na mjestu primjene
English: Application site erythema
Croatian: Eritem na mjestu primjene
English: Each tube contains 235 mcg of ingenol mebutate in 0.47 g of gel.
Croatian: Svaka tuba sadrži 235 µg ingenol mebutata u 0,47 g gela.
English: Eye lid oedema
Croatian: Edem kapka
English: Picato 150 mcg/g gel (n=42)
Croatian: Picato 150 µg/g gel (n=42)
English: Each tube contains 70 mcg of ingenol mebutate in 0.47 g of gel.
Croatian: Svaka tuba sadrži 70 µg ingenol mebutata u 0,47 g gela.
English: On the treatment area: - Tingling or numbness (paraesthesia) - Open sores (ulcer) - Change in skin colour (pigmentation change)
Croatian: - Promjena boje kože (promjena u pigmentaciji) Druge nuspojave: - Bol u oku