FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 4 Number and percent (95% CI) of subjects achieving complete and partial clearance at day 57 by anatomical location trunk and extremities
Maltese: Tabella 4 Numru u perċentwali (95% CI) ta' persuni li kisbu fejqan komplet u parzjali f'jum 57 skont il-post anatomiku fuq it-tronk u l-estremitajiet
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.
Maltese: Keratoacanthoma, karċinoma taċ-ċelloli bażali, marda ta' Bowen, karċinoma taċ-ċelloli skwamużi Rapporti ta' keratoacanthoma, karċinoma taċ-ċelloli bażali, marda ta' Bowen, karċinoma taċ-ċelloli skwamużi li jseħħu fiż-żona ta' kura, fejn iż-żmien qabel ma jibda jidher l-effett ivarja minn ġimgħat għal xhur wara l-użu ta' ingenol mebutate ġell, wasslu minn prova klinika ta' wara l-awtorizzazzjoni (ara sezzjoni 5.1) u wara t-tqegħid fis-suq.
English: Picato 500 micrograms/gram gel is used for actinic keratosis on the body, arms, hands and legs.
Maltese: Picato 500 mikrogramma/gramma ġell jintuża għal keratożi aktinika fuq il-ġisem, dirgħajn, idejn u riġlejn.
English: Chemical conjunctivitis, corneal burn**
Maltese: Konġuntivite kimika, ħruq tal kornea**
English: Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, other chemotherapeutics, ATC code: D06BX02.
Maltese: Antibijotiċi u mediċini kimoterapewtiċi għal użu dermatoloġiku, kimoterapewtiċi oħrajn, Kodiċi ATC:
English: As a precautionary measure, it is preferable to avoid the use of Picato during pregnancy.
Maltese: Bħala miżura ta' prekawzjoni, hu preferibbli li l-użu ta' Picato waqt tqala jiġi evitat.
English: Picato 150 micrograms/g gel ingenol mebutate
Maltese: Picato 150 mikrogramma/g ġell ingenol mebutate
English: Picato 500 micrograms/gram gel
Maltese: Picato 500 mikrogramma/gramma ġell
English: Lesion Based Recurrence Rateb 12 months
Maltese: Rata ta' Rikorrenza Bbażata fuq ilLeżjonijietb 12-il xahar
English: Animal studies showed slight embryo-fetal toxicity (see section 5.3).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża (ara sezzjoni 5.1).
English: Safety results from the study were comparable to the safety profile of Picato gel, 150 mcg/g as monotherapy
Maltese: Ir-riżultati tas-sigurtà mill-istudju kienu komparabbli mal-profil tas-sigurtà tal-ġell Picato, 150 µg/g bħala monoterapija.
English: Picato 150 micrograms/gram gel
Maltese: Picato 150 mikrogramma/gramma ġell
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.
Maltese: Lista f'tabella ta' reazzjonijiet avversi Tabella 1 tirrifletti l-esponiment għal Picato 150 µg/g jew 500 µg/g f'499 pazjent b'keratożi aktinika kkurati f'erba' studji ta' fażi 3 ikkontrollati bi plaċebo, li fihom kellhom irreġistrati total ta' 1002 pazjenti u rapporti ta' wara t-tqegħid fis-suq.
English: Headache
Maltese: Picato
English: Paediatric population There is no relevant use of Picato in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' Picato fil-popolazzjoni pedjatrika.
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.
Maltese: Fi studju double blind, ikkontrollat bi plaċebo, ingħataw sa żewġ korsijiet ta' kura ta' Picato 150 µg/g lil 450 pazjent b'4-8 AKs f'żona ta' kura ta' 25 cm2 fuq il-wiċċ jew il-qorriegħa.
English: Picato 150 mcg/g (n=277)
Maltese: Picato 150 µg/g (n=277 )
English: Picato 150 mcg/g (n=277 )
Maltese: Picato 150 µg/g (n=277)
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.
Maltese: L-istudju rreġistra pazjenti b'4 sa 8 leżjonijiet AK klinikament tipiċi, viżibbli, diskreti, mhux ipertrofiċi u mhux iperkeratotiċi f'żona kontigwa ta' kura ta' 25 cm2.
English: Picato 500 mcg/g gel Trunk and extremities
Maltese: - Uża Picato 500 mikrogramma/g ġell (it-tronk u l-estremitajiet)
English: Package leaflet: Information for the patient Picato 150 micrograms/gram gel ingenol mebutate This medicine is subject to additional monitoring.
Maltese: Informazzjoni għall-pazjent Picato 150 mikrogramma/gramma ġell ingenol mebutate Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: This medicine is used for topical (on the skin) treatment of actinic keratosis, also called solar keratosis, in adults.
Maltese: Din il-mediċina tintuża għall-kura topika (fuq il-ġilda) ta' keratożi aktinika, li tissejjaħ ukoll keratożi solari, fl-adulti.
English: Study patients ranged from 34 to 89 years of age (mean 64 and 66 years, respectively, for the two strengths) and 94% had Fitzpatrick skin type I, II, or III.
Maltese: Il-pazjenti fl-istudju kellhom minn 34 sa 89 sena (medja ta' 64 u 66 sena, rispettivament, għaż-żewġ qawwiet) u 94% kellhom tip I, II jew III ta' ġilda Fitzpatrick.
English: Swelling of the application site is very common (has been reported in more than 1 in 10 people).
Maltese: Nefħa fis-sit tal-applikazzjoni hi komuni ħafna (ġiet irrappurtata f'iktar minn 1 minn kull 10 persuni).
English: Picato 500 micrograms/g gel ingenol mebutate
Maltese: Picato 500 mikrogramma/g ġell ingenol mebutate
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.
Maltese: L-effikaċja u s-sigurtà ta' Picato 150 µg/g, applikat fuq il-wiċċ jew qorriegħa għal 3 ijiem konsekuttivi, ġiet studjata f'żewġ studji kliniċi, double-blind, ikkontrollati bi plaċebo, li kienu jinkludu 547 pazjent adulti.
English: Single-dose laminate tubes with inner layer of High Density Polyethylene (HDPE) and aluminium as the barrier layer.
Maltese: Stoċċijiet laminati b'doża waħda b'saff intern ta' Polyethylene b'Densità Għolja (HDPE) u aluminju bħala s-saff li jostakola.
English: c Of these, 38 subjects were previously treated in a vehicle controlled phase 3 study and 38 subjects were previously treated in an uncontrolled phase 3 study.
Maltese: ċ Minn dawn, 38 individwu ġew ikkurati fil-passat fi studju kkontrollat bi plaċebo ta' fażi 3 u 38 individwu ġew ikkurati fil-passat fi studju mhux ikkontrollat ta' fażi 3.
English: At end of study (day 57), the rate of squamous cell carcinoma (SCC) reported in the treatment area was comparable in patients treated with ingenol mebutate gel (0.3%, 3 of 1,165 patients) and in vehicle treated patients (0.3%, 2 of 632 patients) in the actinic keratosis clinical studies conducted with ingenol mebutate gel.
Maltese: Riskju ta' progressjoni għal karċinoma taċ-ċelloli skwamużi Fit-tmien tal-istudju (jum 57), ir-rata ta' karċinoma taċ-ċelloli skwamużi (SCC) irrapportata fiż-żona tal-kura kienet komparabbli f'pazjenti kkurati b'ingenol mebutate ġell (0.3%, 3 minn 1,165 pazjent) u f'pazjenti kkurati bi plaċebo (0.3%, 2 minn 632 pazjent) fi studji kliniċi dwar keratożi aktinika li saru b'ingenol mebutate ġell.
English: Other side effects: - Eye pain - Injury or irritation to the surface of the eye (cornea, conjunctiva) following accidental exposure
Maltese: Effetti sekondarji oħrajn: - Korriment jew irritazzjoni tal-wiċċ tal-għajn (kornea, konġuntiva) wara esponiment aċċidentali
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.
Maltese: - Il-kura ta' keratożi aktinika fuq il-ġisem, dirgħajn, idejn u riġlejn tikkonsisti minn stoċċ wieħed ta' Picato 500 mikrogramma/g ġell (li fih 235 mikrogramma ta' ingenol mebutate) darba kuljum għal jumejn konsekuttivi.
English: Picato 500 mcg/g was well tolerated when applied to a contiguous treatment area of 100 cm2 on the trunk and extremities.
Maltese: Picato 500 µg/g ġie ttollerat tajjeb meta applikat fuq żona kontigwa ta' kura ta' 100 cm2 fuq it-tronk u l-estremitajiet.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu
English: Picato 500 mcg/g (n=226 )
Maltese: Picato 500 µg/g (n=226)
English: Picato 500 mcg/g (n=226)
Maltese: Picato 500 µg/g (n=226 )
English: Each tube contains 235 micrograms of ingenol mebutate in 0.47 g of gel.
Maltese: Kull stoċċ fih 235 mikrogramma ta' ingenol mebutate f'0.47 g ta' ġell.
English: Vehicle (n=232 )
Maltese: (n=232)
English: Vehicle (n=232)
Maltese: (n=232 )
English: Vehicle (n=270 )
Maltese: (n=270)
English: Vehicle (n=270)
Maltese: (n=270 )
English: Table 2 Rates of subjects with complete and partial clearance and median percent (%) lesion reduction in actinic keratosis
Maltese: Tabella 2 Rati ta' individwi b'fejqan kompleta u parzjali u medjan ta' tnaqqis perċentwali (%) ta' leżjonijiet f'keratożi aktinika
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.
Maltese: Fi studju double-blind, ikkontrollat bi plaċebo, li sar biex jevalwa l-esponiment sistemiku, Picato 500 µg/g, minn 4 stoċċijiet, ġie applikat fuq żona kontigwa ta' kura ta' 100 cm2 kuljum għal jumejn konsekuttivi.
English: In vitro study results demonstrate that ingenol mebutate does not inhibit or induce human cytochrome P450 isoforms.
Maltese: Riżultati in vitro juru li ingenol mebutate ma jinibixxix jew jinduċi isoformi umani ta' ċitokrom P450.
English: - Avoid sunlight as much as possible (including sunlamps and tanning beds).
Maltese: - Evita kemm jista' jkun id-dawl tax-xemx (dan jinkludi sunlamps u tanning beds).
English: Ingestion
Maltese: Plaċebo
English: Efficacy, measured as complete and partial clearance rate, as well as median percent reduction, was assessed at day 57 (see table 2).
Maltese: tnaqqis perċentwali, ġiet evalwata f'jum 57 (ara t-tabella 2).
English: Table 3 Number and percent (95% CI) of subjects achieving complete and partial clearance at day 57 by anatomical location face and scalp
Maltese: Tabella 3 Numru u perċentwali (95% CI) ta' persuni li kisbu fejqan komplet u parzjali f'jum 57 skont il-post anatomiku fuq il-wiċċ u l-qorriegħa
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.
Maltese: Bl-istess mod, l-effikaċja u s-sigurtà ta' Picato 500 µg/g, applikat fuq it tronk u l-estremitajiet għal jumejn konsekuttivi, ġiet studjata f'żewġ studji kliniċi, double-blind, ikkontrollati bi plaċebo, li kienu jinkludu 458 pazjent adulti.
English: Picato is indicated for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults.
Maltese: Picato hu indikat għall-kura kutanea ta' keratożi mhux iperkeratotika u keratożi aktinika mhux ipertrofika f'adulti.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Maltese: F'kull kategorija ta' frekwenza, ir-reazzjonijiet avversi qed jiġu ppreżentati f'ordni ta' severità dejjem tonqos.
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).
Maltese: Punteġġi medji globali ogħla ta' sodisfazzjon tal-pazjenti, li jindikaw livell ogħla ta' sodisfazzjoni globali, ġew osservati fil-gruppi kkurati b'ingenol mebutate meta mqabbla mal-gruppo kkurati bi plaċebo (p<0.001) kif imkejla permezz tal-Kwestjonarju tas' Sodisfazzjon bil-Kura għal Medikazzjoni (TSQM - Treatment Satisfaction Questionnaire for Medication).
English: The systemic pharmacokinetic profile of ingenol mebutate and its metabolites has not been characterised in humans due to the absence of quantifiable whole blood levels following cutaneous administration.
Maltese: Il-profil farmakokinetiku sistemiku ta' ingenol mebutate u l-metaboliti tiegħu ma ġiex ikkaratterizzat fil-bnedmin minħabba n-nuqqas ta' livelli kwantifikabbli fid-demm sħiħ wara l-għoti fuq il-ġilda.
English: Management of actinic keratosis
Maltese: KONKLUŻJONIJIET XJENTIFIĊI
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.
Maltese: Il-pazjenti kellhom minn 4 sa 8 leżjonijiet ikkawżati minn keratożi aktinika klinikament tipiċi, viżibbli, diskreti, mhux iperkeratotiċi, mhux ipertrofiċi f'żona kontigwa ta' kura ta' 25 cm2 fuq il-wiċċ jew il-qorriegħa jew fuq it-tronk jew estremitajiet.
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.
Maltese: L-iktar reazzjonijiet avversi frekwenti li ġew irrapportati b'mod komuni kienu risponsi lokali tal-ġilda li jinkludu eritema, tqaxxir/il-ġilda titfarfar, qxur, nefħa, vesikulazzjoni/pustulazzjoni u erożjoni/ulċerazzjoni fis-sit tal-applikazzjoni ta' ingenol mebutate ġell, ara tabella 1 għat-termini
English: Uncommon side effects, may affect up to 1 in 100 people:
Maltese: Effetti sekondarji mhux komuni, jistgħu jaffettwaw sa persuna 1 minn kull 100 persuna:
English: Table 6 Complete clearancea of the field 8 weeks after randomisation and Month 12 Field recalcitrantc
Maltese: Tabella 6 Tneħħija kompletaa miż-żona ta' kura 8 ġimgħat wara l-għażla b'mod każwali u
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.
Maltese: 150 mikrogramma/g ġell (li fih 70 mikrogramma ta' ingenol mebutate) darba kuljum għal 3 ijiem konsekuttivi.
English: Application site vesicles
Maltese: Vexxikuli fis-sit talapplikazzjoni
English: Application site pigmentation changes
Maltese: .8 Effetti mhux mixtieqa
English: Picato 150 mcg/g gel (n=42)
Maltese: Picato 150 µg/g ġell (n=42)
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).
Maltese: Risponsi lokali tal-ġilda bħal eritema, tqaxxir/tfarfir tal-ġilda, u qxur għandhom jiġu mistennija li jseħħu wara l-applikazzjoni fuq il-ġilda ta' Picato (ara sezzjoni 4.8).
English: How to store Picato
Maltese: X'fih Picato
English: Complete Clearance
Maltese: Fejqan komplet
English: To be printed on the inside of the carton lid:
Maltese: Biex jiġi stampat fuq in-naħa ta' ġewwa tal-għatu tal-kartuna:
English: - Warmth
Maltese: Treddigħ
English: gel 2 tubes
Maltese: ġell 2 stoċċijiet
English: Each tube contains 70 micrograms of ingenol mebutate in 0.47 g of gel.
Maltese: Kull stoċċ fih 70 mikrogramma ta' ingenol mebutate f'0.47 g ta' ġell.
English: Application site exfoliation Very common
Maltese: Ċikatriċi fis-sit tal-applikazzjoni Rari
English: No systemic absorption was detected at or above the lower limit of detection (0.1 ng/mL) when Picato 500 mcg/g from 4 tubes was applied to an area of 100 cm2 on the dorsal forearm in actinic keratosis patients once daily for 2 consecutive days.
Maltese: Ma ġie osservat l-ebda assorbiment sistemiku fi jew 'il fuq mil-limitu l-aktar baxx ta'osservazzjoni (0.1 ng/mL) meta Picato 500 µg/g minn 4 stoċċijiet ġie applikat fuq żona ta' 100 cm2 fuq il-parti dorsali tad-driegħ mill-minkeb 'l isfel f'pazjenti b'keratożi aktinika darba kuljum għal jumejn konsekuttivi.
English: Chest
Maltese: Sentejn
English: Each gram of gel contains 150 micrograms of ingenol mebutate.
Maltese: Kull gramma ta' ġell fiha 150 mikrogramma ta' ingenol mebutate.
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.
Maltese: Fi studju double-blind ikkontrollat bi plaċebo, fuq pazjenti b'AK fuq it-tronk u l-estremitajiet, ġie applikat prodott fil-fażi ta' investigazzjoni b'ingenol mebutate ġell 600 µg/g darba kuljum, għal jumejn, tlitt ijiem jew erbat ijiem fuq erja tal-ġilda ta' 250 cm2.
English: Statistically significant differences in patient reported outcomes were observed in favour of patients receiving Picato compared to those receiving vehicle gel.
Maltese: Ġew osservati differenzi statistikament sinifikanti f'riżultati rrapportati mill-pazjenti favur pazjenti li kienu qed jirċievu Picato meta mqabbla ma' dawk li kienu qed jirċievu ġell plaċebo.
English: Picato 500 micrograms/g gel is clear and colourless and each carton contains 2 tubes with 0.47 g of gel each.
Maltese: Picato 500 mikrogramma/g ġell hu ċar u bla kulur u kull kartuna fiha 2 stoċċijiet b'0.47 g ta' ġell f'kull wieħed.
English: Picato 150 mcg/g gel is available in a carton containing 3 tubes with 0.47 g of gel each.
Maltese: Picato 150 mikrogramma/g ġell hu ċar u bla kulur u kull kartuna fiha 3 stoċċijiet b'0.47 g ta' ġell f'kull wieħed.
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.
Maltese: Fi studju li sar aktar tard, 450 pazjent ġew ikkurati inizjalment b'Picato 150 µg/g, minn dawn, 134 pazjent intgħażlu b'mod każwali għat-tieni kors b'Picato 150 µg/g, u l-pazjenti ġew segwiti għal sa 12-il xahar wara l-ewwel kura.
English: 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.
Maltese: Is-sigurtà tal-kura b'Picato 150 µg/g għal 3 ijiem jew kura b'Picato 500 µg/g għal jumejn, ġiet evalwata sa jum 57, il-maġġoranza tar-reazzjonijiet avversi rrappurtati u r-risponsi lokali tal-ġilda kienu minn ħfief sa moderati fl-intensità u kollha fiequ mingħajr ma reġgħu tfaċċaw.
English: Each tube contains 235 mcg of ingenol mebutate in 0.47 g of gel.
Maltese: Kull stoċċ fih 235 µg ta' ingenol mebutate f'0.47 g ta' ġell.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ingenol mebutate, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal ingenol mebutate, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Face Scalp
Maltese: DATA TA' SKADENZA
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.
Maltese: Sabiex tiġi investigata r-rata ta' tumuri malinni tal-ġilda (karċinoma taċ-ċelloli skwamużi, marda ta' Bowen, karċinoma taċ-ċelloli bażali, keratoacanthoma, melanoma malinna) f'pazjenti b'keratożi aktinika kkurati b'ingenol mebutate, lMAH għandu jwettaq u jippreżenta r-riżultati ta' studju dwar koorti li jqabbel ilpazjenti kkurati b'ingenol mebutate ma' pazjenti esposti għal kuri oħra ta' keratożi aktinika.
English: c Median percent (%) reduction in actinic keratosis lesions compared to baseline.
Maltese: ċ Tnaqqis medjan f'perċentwali (%) f'leżjonijiet ikkawżati minn keratożi aktinika mqabbla mal-linja bażi.
English: Severe local skin responses occurred with an incidence of 29% on the face and scalp and with an incidence of 17% on the trunk and extremities.
Maltese: Risponsi lokali severi tal-ġilda seħħew b'inċidenza ta' 29% fuq il-wiċċ u l-qorriegħa u b'inċidenza ta' 17% fuq it-tronk u l-estremitajiet.
English: Each gram of gel contains 500 micrograms of ingenol mebutate.
Maltese: Kull gramma ta' ġell fiha 500 mikrogramma ta' ingenol mebutate.
English: Non-invasive examination of the treated skin by reflectance confocal microscopy have shown that the skin changes induced by ingenol mebutate were reversible, with almost complete normalisation of all measured parameters on day 57 after treatment, which is supported also by clinical findings and studies in animals.
Maltese: Eżami mhux invażiv tal-ġilda kkurata permezz ta' mikroskopija konfokali ta' riflettanza wera li t tibdil fil-ġilda kkaġunat minn ingenol mebutate kien riversibbli, b'normalizzazzjoni kważi għal kollox tal-parametri kollha mkejla f'jum 57 wara l-kura, ħaġa li hija appoġġjata wkoll minn riżultati kliniċi u studji fuq l-annimali.
English: Taking into account the treatment purpose for actinic keratosis, which is prevention of skin malignancy, and considering the number of skin tumour cases reported to ingenol mebutate in clinical trials and post-marketing, the PRAC has serious concerns about the impact of the risk of skin tumours on the benefit risk balance of Picato.
Maltese: Meta jiġi kkunsidrat l-iskop ta' trattament għall-keratożi aktinika, li huwa l-prevenzjoni ta' tumuri malinni tal-ġilda, u meta jiġi kkunsidrat in-numru ta' każijiet ta' tumuri fil-ġilda rrappurtati għallingenol mebutate fi provi kliniċi u wara t-tqegħid fis-suq, il-PRAC għandu tħassib serju dwar l-impatt ta' riskju tat-tumuri fil-ġilda fuq il-bilanċ bejn il-benefiċċju u r-riskju ta' Picato.
English: The PRAC is of the opinion that a thorough review is needed of the impact of all available data related to skin malignancies, including the results of study LP0041-63, on the benefit risk balance of Picato.
Maltese: Il-PRAC huwa talopinjoni li hemm bżonn li titwettaq reviżjoni bir-reqqa tal-impatt tad-dejta kollha relatata mat-tumuri malinni tal-ġilda, inklużi r-riżultati tal-istudju LP0041-63, dwar il-bilanċ bejn il-benefiċċju u r-riskju ta' Picato.
English: - This medicine is intended to treat one area of 25 cm2 for two days.
Maltese: - Din il-mediċina hi intenzjonata biex tikkura żona waħda ta' 25 ċm2 għal tliet ijiem.
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).
Maltese: Il-medjan ta' tnaqqis perċentwali ta' leżjonijiet ikkawżati minn keratożi aktinika kien ogħla fil-grupp ikkurat b'ingenol mebutate meta mqabbel mal-grupp ikkurat bil-plaċebo (ara t-tabella 2).
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.
Maltese: Il-pazjenti rċivew kura fiż-żona (żona ta' 25 ċm2) b'Picato f'konċentrazzjonijiet ta' 150 µg/g jew 500 µg/g jew plaċebo darba kuljum għal 3 ijiem jew jumejn konsekuttivi rispettivament.
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.
Maltese: Keratożi Aktinika tal-Wiċċ u tal-Qorriegħa, l-użu sekwenzjali wara l-krijoterapija Fi studju b'żewġ partijiet, 329 pazjent adult b'AK fuq il-wiċċ jew il-qorriegħa, intgħażlu b'mod każwali għall-kura bil-ġell Picato, 150 µg/g jew plaċebo 3 ġimgħat wara l-krijoterapija tal-leżjonijiet kollha viżibbli fiż-żona tal-kura.
English: Drink plenty of water if you accidentally swallow this medicine and seek medical assistance.
Maltese: Ixrob ħafna ilma jekk tibla' aċċidentalment din il-mediċina u fittex assistenza medika.