FrancophonIA/ELRC3.0 huggingface dataset:
English: The study involved 148 patients with transfusion-dependent anaemia, low or intermediate (level 1) risk myelodysplastic syndromes and a deletion of part of chromosome 5 (‘5q deletion').
Maltese: L-istudju kien jinvolvi 148 pazjent b'anemija dipendenti fuq trasfużjoni, b'sindromi mjelodisplastiċi b'riskju baxx jew intermedju (livell 1) u tħassir ta' parti mill-kromosoma 5 (‘tħassir 5q').
English: The balance of benefits and risks for Revlimid remains unchanged.
Maltese: Il-bilanċ tal-benefiċċji u r-riskji għal Revlimid jibqa' l-istess.
English: What is Lenalidomide Celgene Europe?
Maltese: X'inhu Lenalidomide Celgene Europe?
English: On 30 May 2008, Celgene Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lenalidomide Celgene Europe, for the treatment of anaemia due to myelodysplastic syndromes.
Maltese: Fit-30 ta' Mejju 2008, Celgene Europe Limited uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Lenalidomide Celgene Europe, għat-trattament ta' anemija kkawżata minn sindromi mjelodisplastiċi (anaemia due to myelodysplastic syndromes).
English: This means that it affects the activity of the immune system (the body's natural defences).
Maltese: Dan ifisser li jaffettwa l-attività s-sistema immunitarja (id-difiżi naturali tal-ġisem).
English: The study looked at the effects of treatment with a daily dose of 10 mg Lenalidomide Celgene Europe either given continuously or as a repeated cycle of three weeks on treatment followed by one week off.
Maltese: L-istudju ħares lejn l-effetti ta' trattament b'doża ta' 10 mg kuljum ta' Lenalidomide Celgene Europe jew kontinwament jew li jingħata bħala ċiklu ripetut għal tliet ġimgħat bi trattament segwit b'ġimgħa mingħajr trattament.
English: The evaluation had finished and the CHMP had given a negative opinion, which had been confirmed following a re-examination procedure.
Maltese: L-evalwazzjoni kienet intemmet u s-CHMP kien ta opinjoni negattiva, li kienet ġiet ikkonfermata wara proċedura ta' evalwazzjoni mill-ġdid.
English: In particular, because the study did not compare the medicine to any other treatment, it was difficult to determine if treatment with Lenalidomide Celgene Europe increased the risk of progression to acute myeloid leukaemia.
Maltese: B'mod partikolari, minħabba li l-istudju ma qabbilx il-mediċina ma' l-ebda trattament ieħor, kien diffiċli li jiġi determinat jekk it-trattament b'Lenalidomide Celgene Europe żied ir-riskju ta' progressjoni għal lewċemija mjelojde akuta.
English: Its effectiveness was studied in one main study, carried out in a number of hospitals and clinics (‘sites') in the United States of America and Germany.
Maltese: L-effikaċja tiegħu kienet studjata fi studju ewlieni wieħed li twettaq f'għadd ta' sptarijiet u kliniċi (‘siti') fl-Istati Uniti ta' l-Amerka u fil-Ġermanja.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Lenalidomide Celgene Europe for the for the treatment of anaemia due to myelodysplastic syndromes.
Maltese: Skond l-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP fiżżmien l-irtirar, is-CHMP kien ta opinjoni negattiva u ma rrakkomandax li tingħata l-awtorizzazzjoni għat-tqegħid fis-suq għal Lenalidomide Celgene Europe għat-trattament ta' l-anemija kkawżata minn sindromi mjelodisplastiċi.
English: What is happening with Revlimid used for the treatment of multiple myeloma?
Maltese: X'isir b'Revlimid li jintuża fit-trattament ta' mjeloma multipla?
English: How is Lenalidomide Celgene Europe expected to work?
Maltese: Għal xiex kien mistenni li jintuża Lenalidomide Celgene Europe?
English: Lenalidomide Celgene Europe was to be used in patients who were dependent on receiving blood transfusions to treat their anaemia and whose myelodysplastic syndromes were associated with a specific genetic mutation (deletion of part of chromosome number 5), and with a low to intermediate risk of progressing to leukaemia or death.
Maltese: Lenalidomide Celgene Europe kellu jintuża f'pazjenti li kienu dipendenti fuq trasfużjonijiet tad-demm għat-trattament ta' l-anemija b'sindromi mjelodisplastiċi kienu assoċjati ma' tibdil ġenetiku speċifiku (tħassir ta' parti minn kromosoma numru 5), u b'riskju baxx jew intermedju għall-progressjoni għallewċemija jew il-mewt.
English: The effects of Lenalidomide Celgene Europe were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Lenalidomide Celgene Europe għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fil-bniedem.
English: Lenalidomide Celgene Europe was expected to be used to treat anaemia (low red blood cell counts) caused by myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Maltese: Lenalidomide Celgene Europe kien mistenni li jintuża fit-trattament ta' anemija (livelli baxxi ta' ċelluli ħomor tad-demm) ikkawżata minn sindromi mjelodisplastiċi, grupp ta' kundizzjonijiet fejn jkunu prodotti ftit ċelluli tad-demm fil-mudullun ta' l-għadam.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Lenalidomide Celgene Europe?
Maltese: X'inhuma l-konsegwenzi ta' l-irtirar għal dawk il-pazjenti li kienu involuti fi provi kliniċi jew programmi ta' użu b'kumpassjoni bl-użu ta' Lenalidomide Celgene Europe?
English: The exact way that lenalidomide works in myelodysplastic syndromes is not known, but it is thought that it blocks the growth of tumour cells in the bone marrow, while allowing the growth of normal bone marrow cells, including the cells that produce red blood cells.
Maltese: Il-mod eżatt kif jaħdem lenalidomide fis-sindromi mjelodisplastiċi mhuwiex magħruf, iżda hu maħsub li jimblokka t-tkabbir taċ-ċelluli tat-tumur fil-mudullun ta' l-għadam, filwaqt li jippermetti t-tkabbir taċ-ċelluli normali talmudullun ta' l-għadam, inklużi ċ-ċelluli li jipproduċu ċ-ċelluli ħomor tad-demm.
English: --1 Live attenuated Muscovy duck parvovirus ≥ 2.6 log10 CCID50 * * Cell culture infectious dose 50%
Maltese: --1 Parvovirus ħaj mdgħajjef tal-papra Muscovy 2.6 - 4.8 log10 CCID*50 Cell culture doża infettiva 50%
English: 1 bag + 1 trocar
Maltese: Borża + trocar
English: 1 vial
Maltese: Ippakkjar
English: 10 bags + 10 trocars
Maltese: 500 doża 10 kunjetti
English: Muscovy ducks
Maltese: Perjodu ta' Tiżmim
English: EU (MA) Number
Maltese: Numru ta' l-UE Isem kummerċjali
English: The full EPAR for Relistor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 12-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'12-2016.
English: The percentages of successful injections for the two groups were around 30% and 9%, respectively.
Maltese: Il-perċentwal ta' injezzjonijiet li rnexxew għaż-żewġ gruppi kien madwar 30% u 9%, rispettivament.
English: Relistor methylnaltrexone bromide
Maltese: Relistor bromur tal-metilnaltrekson
English: Other information about Relistor
Maltese: Informazzjoni oħra dwar Relistor
English: The active substance in Relistor, methylnaltrexone bromide, is a ‘mu-opioid receptor antagonist'.
Maltese: Is-sustanza attiva f'Relistor, il-bromur tal-metilnaltrekson, hija 'antagonista ta' riċettur mu-opjojde'.
English: Relistor contains the active substance methylnaltrexone bromide.
Maltese: Relistor fih is-sustanza attiva bromur tal-metilnaltrekson.
English: This is a summary of the European public assessment report (EPAR) for Relistor.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Relistor.
English: In the second study, 52% of the patients receiving Relistor had a bowel movement at least twice within four hours of the first four doses (32 out of 62), compared with 8% of those receiving placebo (6 out of 71).
Maltese: Fit-tieni studju, 52% tal-pazjenti li rċevew Relistor kellhom moviment fl-imsaren minn tal-inqas darbtejn fi żmien erba' sigħat mill-ewwel erba' dożi (32 minn 62), meta mqabbla ma' 8% ta' dawk li rċevew plaċebo (6 minn 71).
English: Relistor was shown to be more effective than placebo (a dummy treatment) at stimulating bowel movement in two main studies involving a total of 288 patients with an advanced illness and constipation caused by opioids.
Maltese: Intwera li Relistor kien aktar effettiv minn plaċebo (kura finta) biex jistimula l-moviment fl-imsaren f'żewġ studji ewlenin li fihom ħadu sehem total ta' 288 pazjent b'marda avvanzata u stitikezza kkawżata mill-opjojdi.
English: Why is Relistor approved?
Maltese: Għaliex ġie approvat Relistor?
English: Results showed that 34% of patients receiving Relistor (102 out of 298) had a bowel movement within four hours after the first injection, compared with 10% of those receiving placebo (16 out of 162).
Maltese: Ir-riżultati wrew li 34% tal-pazjenti li rċevew Relistor (102 minn 298) kellhom moviment fl-imsaren fi żmien erba' sigħat wara l-ewwel injezzjoni, meta mqabbla ma' 10% ta' dawk li rċevew plaċebo (16 minn 162).
English: The most common side effects with Relistor (seen in more than 1 patient in 10) are abdominal pain (stomach ache), nausea (feeling sick), diarrhoea and flatulence.
Maltese: L-effetti sekondarji l-aktar komuni b'Relistor (li jidhru f'aktar minn pazjent wieħed minn kull 10) huma wġigħ addominali (uġigħ ta' stonku), nawżja (dardir), dijarrea u flatulanza (gass).
English: Relistor has also been compared with placebo in a third study involving 496 patients with constipation caused by opioids, but no advanced illness.
Maltese: Relistor tqabbel ukoll ma' plaċebo fit-tielet studju li fih ħadu sehem 496 pazjent bi stitikezza kkawżata mill-opjojdi, iżda mhux minn marda avvanzata.
English: The dose of Relistor should be reduced in patients who have severe kidney problems.
Maltese: Id-doża ta' Relistor għandha titnaqqas f'pazjenti li għandhom problemi serji fil-kliewi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Relistor on 2 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Relistor fit-2 ta' Lulju 2008.
English: In patients not on palliative care, Relistor is given as an injection under the skin at a dose of 12 mg once a day, for at least 4 days per week and up to 7 days per week as needed; treatment with usual laxatives should be stopped when starting Relistor.
Maltese: F'pazjenti li mhux qed jirċievu kura palljativa, Relistor jingħata bħala injezzjoni taħt il-ġilda b'doża ta' 12 mg darba kuljum, għal minn tal-inqas erbat ijiem fil-ġimgħa u sa mhux aktar minn sebat ijiem fil-ġimgħa skont kif meħtieġ; il-kura bil-lassattivi tas-soltu għandha titwaqqaf meta jinbeda Relistor.
English: Relistor is not recommended for patients who have very severe kidney problems that require dialysis (a blood clearance technique).
Maltese: Relistor mhuwiex rakkomandat għal pazjenti li għandhom problemi serji fil-kliewi jew li jeħtieġu dijaliżi (teknika ta' tindif tad-demm).
English: Looking at the results of the two studies taken together, 55% of the patients receiving Relistor had a bowel movement within four hours of the first dose (91 out of 165), compared with 15% of the patients receiving placebo (18 out of 123).
Maltese: Ħarsa lejn ir-riżultati taż-żewġ studji meħudin flimkien, 55% tal-pazjenti li rċevew Relistor kellhom moviment fl-imsaren fi żmien erba' sigħat mill-ewwel doża (91 minn 165), meta mqabbla ma' 15% tal-pazjenti li rċevew plaċebo (18 minn 123).
English: For the full list of all side effects reported with Relistor, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Relistor, ara l-fuljett ta' tagħrif.
English: What are the risks associated with Relistor?
Maltese: X'inhuma r-riskji assoċjati ma' Relistor?
English: How does Relistor work?
Maltese: Kif jaħdem Relistor?
English: In patients who are receiving palliative care (treatment of the symptoms of a serious disease that is not intended to lead to cure), Relistor is given as an injection under the skin, once every two days, in addition to the usual laxative medicines.
Maltese: F'pazjenti li qed jirċievu kura palljativa (kura tas-sintomi ta' marda serja li mhix maħsuba li twassal għall-kura), Relistor jingħata bħala injezzjoni taħt il-ġilda, darba kull jumejn, flimkien mal-mediċini lassattivi tas-soltu.
English: Methylnaltrexone bromide is derived from naltrexone, a well-known substance that is used to block the action of opioids.
Maltese: Il-bromur talmetilnaltrekson tinkiseb minn naltrekson, sustanza magħrufa sewwa li tintuża biex timblokka l-azzjoni tal-opjojdi.
English: Relistor must not be used in patients whose bowel is blocked, who are at risk of recurrent bowel blockage or who have a condition that needs immediate bowel surgery.
Maltese: Relistor m'għandux jintuża f'pazjenti li l-imsaren tagħhom huma mblokkati, li qegħdin f'riskju ta' mblokk rikurrenti fl-imsaren jew li għandhom kundizzjoni li teħtieġ kirurġija immedjata fl-imsaren.
English: • Educational material
Maltese: • Materjal edukattiv
English: • Posology
Maltese: • Pożoloġija
English: • Information on the identified and potential risks.
Maltese: • Informazzjoni dwar ir-riskji identifikati u potenzjali.
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Maltese: • Sommarju tal-Karatteristiċi tal-Prodott (SPC) u Fuljett ta' Tagħrif u Tikketta
English: The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jiftiehem dwar id-dettalji ta' programm edukattiv mal-Awtoritajiet Kompetenti Nazzjonali u jrid jimplimenta dan il-programm b'mod nazzjonali biex jiżgura li, qabel ma jagħtu r-riċetta, it-tobba kollha jiġu pprovduti b'pakkett ta' tagħrif għall-professjonisti fil-qasam tal-kura tas-saħħa li jkun fih dan li ġej:
English: ANNEX
Maltese: ANNESS
English: • Information on gel depot formation and possible injections site reactions
Maltese: • Informazzjoni dwar il-formazzjoni ta' ġell depot u reazzjonijiet possibbli fis-sit tal-injezzjonijiet
English: Key elements to be included in the educational material
Maltese: Elementi ewlenin li jridu jkunu inklużi fil-materjal edukattiv
English: LEO Laboratories Ltd. 285 Cashel Road Crumlin, Dublin 12 Ireland
Maltese: LEO Laboratories Ltd. 285 Cashel Road Crumlin, Dublin 12 L-Irlanda
English: 285 Cashel Road, Crumlin, Dublin 12 Ireland
Maltese: 285 Cashel Road, Crumlin, Dublin 12 L-Irlanda
English: Date of first authorisation: 15 November 2012 Date of latest renewal: 13 July 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Novembru 2012 Data tal-aħħar tiġdid: 13 ta' Lulju 2017
English: Isopropyl alcohol Hydroxyethylcellulose Citric acid monohydrate Sodium citrate Benzyl alcohol Purified water
Maltese: Isopropyl alcohol Hydroxyethylcellulose Citric acid monohydrate Sodium citrate Benzyl alcohol Ilma ppurifikat
English: KM estimate (95% CI)a
Maltese: Rata ta' Rikorrenza 12-il xahar Stima KM (95% CI)a
English: - The active substance is ingenol mebutate.
Maltese: - Is-sustanza attiva hi ingenol mebutate.
English: Table 1 Adverse reactions by MedDRA System Organ Classification Frequency
Maltese: Tabella 1 Reazzjonijiet avversi skont is-Sistema tal-Klassifika tal-Organi fid-database MedDRA Frekwenza
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: - The other ingredients are isopropyl alcohol, hydroxyethylcellulose, citric acid monohydrate, sodium citrate, benzyl alcohol, purified water.
Maltese: - Is-sustanzi mhux attivi l-oħra huma isopropyl alcohol, hydroxyethylcellulose, citric acid monohydrate, sodium citrate, benzyl alcohol, ilma ppurifikat.
English: Hypersensitivity (including angioedema)
Maltese: Sensittività eċċessiva (li tinkludi anġjoedema)
English: The first treatment course, given open label, resulted in a complete clearance rate of 62% (277/450).
Maltese: L-ewwel kors ta' kura, mogħti open label, irriżulta f'rata ta' tneħħija kompleta ta' 62% (277/450).
English: Picato contains the active substance ingenol mebutate.
Maltese: Picato fih is-sustanza attiva ingenol mebutate.
English: d p<0.001; compared to vehicle by logistic regression with treatment, study and anatomical location.
Maltese: d p<0.001; imqabbla ma' plaċebo permezz ta' rigressjoni loġistika bil-kura, studju, u sit anatomiku.
English: Necrosis in the dermis was rarely observed.
Maltese: In nekrożi fid-dermis ġiet osservata b'mod rari.
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).
Maltese: Fil-firien, ingenol mebutate ma ġiex assoċjat ma' effetti ta' żvilupp fetali f'dożi IV sa 5 µg/kg/kuljum (30 µg/m2/kuljum).
English: Application site pain***
Maltese: Uġigħ fis-sit tal applikazzjoni***
English: b Cochran-Mantel-Haenszel test of Picato® gel 150 mcg/g compared to vehicle adjusted for anatomical location (face/scalp) and country.
Maltese: b Test ta' Cochran-Mantel-Haenszel ta' ġell Picato 150 µg/g imqabbel mal-plaċebo aġġustat għall-post anatomiku (wiċċ/qorriegħa) u l-pajjiż.
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%).
Maltese: L-inċidenza ta' risponsi lokali tal-ġilda li seħħew f'inċidenza ta' >1% kemm fil-‘wiċċ/qorriegħa' u fit‘tronk/estremitajiet', rispettivament huma: eritema fis-sit tal-applikazzjoni (94% u 92%), qxur fis-sit tal-applikazzjoni (85% u 90%), skorċa fis-sit tal-applikazzjoni (80% u 74%), nefħa fis-sit talapplikazzjoni (79% u 64%), vexxikuli fis-sit tal-applikazzjoni (13% u 20%), ponot fis-sit talapplikazzjoni (43% u 23%) u erożjoni fis-sit tal-applikazzjoni (31% u 25%).
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).
Maltese: Anormalitajiet fetali minuri jew varjanti ġew osservati f'feti ta' fniek nisa kkurati f'dożi ta' 1 µg/kg/kuljum (12 µg/m2/kuljum).
English: Rare side effects, may affect up to 1 in 1000 people:
Maltese: Effetti sekondarji rari, jistgħu jaffettwaw sa persuna 1 minn kull 1,000 persuna:
English: Trunk and extremities
Maltese: Tronk u estremitajiet
English: Picato 150 mcg/g
Maltese: Picato 150 µg/g
English: Vehicle (n=49)
Maltese: (n=49)
English: Partial clearance ( ≥ 75%)
Maltese: Fejqan Parzjali (≥75%)
English: Partial Clearance( ≥ 75%)
Maltese: Fejqan parzjali (≥75%)
English: Mean (SD) a The recurrence rate is the Kaplan-Meier (KM) estimate at the target study date of the visit expressed as a percentage (95% CI).
Maltese: Medja (SD) a Ir-rata ta' rikorrenza hi l-istima KaplanMeier (KM) fid-data fil-mira tal-istudju tal-vista, espressa bħala perċentwal (95% CI).
English: Vehicle (n=20)
Maltese: (n=20)
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%).
Maltese: L-inċidenza ta' risponsi severi lokali tal-ġilda li seħħew b'inċidenza ta' >1% kemm fil-‘wiċċ/qorriegħa' u t-‘tronk/estremitajiet', rispettivament huma: eritema fis-sit talapplikazzjoni (24% u 15%), qxur fis-sit tal-applikazzjoni (9% u 8%), skorċa fis-sit tal-applikazzjoni (6% u 4%), nefħa fis-sit tal-applikazzjoni (5% u 3%), u ponot fis-sit tal-applikazzjoni (5% u 1%).
English: Complete Clearance Ratea
Maltese: Rata ta' Fejqan Kompleta
English: Of the 1,165 patients treated with Picato in the actinic keratosis clinical studies conducted with ingenol mebutate gel, 656 patients (56%) were 65 years and older, while 241 patients (21%) were 75 years and older.
Maltese: Mill-1,165 pazjent ikkurati b'Picato fl-istudji kliniċi dwar keratożi aktinika li saru b'ingenol mebutate ġell, 656 pazjent (56%) kellhom 65 sena u aktar, filwaqt li 241 pazjent (21%) kellhom 75 sena u aktar.
English: Picato 500 mcg/g
Maltese: Picato 500 µg/g
English: The percent reduction of the AK count in the Picato group was 83% at 11 weeks and 57% at 12 months, where in the vehicle group it was 78% at 11 weeks and 42% at 12 months.
Maltese: It-tnaqqis perċentwali tal-għadd AK fil-grupp ta' Picato kien ta' 83% wara 11-il ġimgħa u 57% wara 12-il xahar, fejn fil-grupp tal-plaċebo kien ta' 78% wara 11-il ġimgħa u 42% wara 12-il xahar.
English: Caps of HDPE.
Maltese: Għotjien tal-HDPE.
English: Partial Clearance Rateb (≥ 75%)
Maltese: Rata ta' Fejqan Parzjalib (≥75%)
English: The mean number of AKs in the Picato group was 5.7 at baseline, 0.8 at week 11, and 0.9 at month 12 as opposed to 5.8, 1.0 and 1.2 in the vehicle group at these time points.
Maltese: 5.7 fil-linja bażi, 0.8 f'ġimgħa 11, u 0.9 f'xahar 12, meta mqabbel ma' 5.8, 1.0 u 1.2 fil-grupp talplaċebo f'dawn il-punti ta' żmien.
English: A total of 198 patients with complete clearance at day 57 (184 treated with Picato and 14 treated with vehicle) were followed for additionally 12 months.
Maltese: Total ta' 198 pazjent b'fejqan komplet f'jum 57 (184 ikkurati b'Picato u 14 ikkurati bi plaċebo) ġew segwiti għal 12-il xahar addizzjonali.
English: On the treatment area:
Maltese: Kategorija farmakoterapewtika:
English: In vivo and in vitro models have shown a dual mechanism of action for the effects of ingenol mebutate: 1) induction of local lesion cell death and 2) promoting an inflammatory response characterised by local production of proinflammatory cytokines and chemokines and infiltration of immunocompetent cells.
Maltese: Mudelli in vivo u in vitro wrew mekkaniżmu doppju ta' azzjoni għall-effetti ta' ingenol mebutate: 1) induzzjoni tal-mewt taċ-ċelloli tal-leżjoni lokali u 2) il-promozzjoni ta' rispons infjammatorju kkaratterizzat minn produzzjoni lokali ta' cytokines u chemokines proinfjammatorji u infiltrazzjoni ta' ċelloli immunokompetenti.
English: 12/163 subjects treated with an investigational product of ingenol mebutate reported 16 skin tumour events inside the treatment area (1 SCC, 1 Bowen's disease and 14 keratoacanthoma following centralised pathology review) compared to 0/61 in the vehicle group.
Maltese: 12 mill-163 individwu kkurati bi prodott fil-fażi ta' investigazzjoni ta' ingenol mebutate irrappurtaw 16-il każ ta' tumur fil-ġilda fiż-żona ta' kura (1 SCC, 1 marda ta' Bowen u 14-il keratoacanthoma wara reviżjoni tal-patoloġija ċentralizzata) meta mqabbel ma' 0/61 fil-grupp tal-plaċebo.
English: Clinical data on treatment in immunocompromised patients is not available, but systemic risks are not expected since ingenol mebutate is not absorbed systemically.
Maltese: Data klinika fuq il-kura f'pazjenti immunokompromessi mhijiex disponibbli, iżda riskji sistemiċi mhumiex mistennija għax ingenol mebutate ma jiġix assorbit b'mod sistemiku.