FrancophonIA/ELRC3.0 huggingface dataset:
English: Methyl hydroxybenzoate (E 218) 2.0 mg/g cream Propyl hydroxybenzoate (E 216) 0.2 mg/g cream Cetyl alcohol 22.0 mg/g cream Stearyl alcohol 31.0 mg/g cream Benzyl alcohol 20.0 mg/g cream
Maltese: Methyl hydroxybenzoate (E218) 2.0 mg/g ta' krema Propyl hydroxybenzoate (E216) 0.2 mg/g ta' krema Cetyl alcohol 0.2 mg/g ta' krema Stearyl alcohol 31.0 mg/g ta' krema Benzyl alcohol 20.
English: Date of first authorisation: 18/09/1998 Date of last renewal: 03/09/2008
Maltese: Data tal-ewwel awtorizzazzjoni: 18/09/1998 Data tal-aħħar tiġdid: 03/09/2008
English: Vulval disorder
Maltese: Disturb vulvali
English: 12 sachets.
Maltese: 12-il qartas.
English: The recurrence rate for individual lesions was 5.6% (41/737).
Maltese: Ir-rata ta' rikorrenza għal leżjonijiet individwali kienet ta' 5.6% (41/737).
English: Cream
Maltese: Krema
English: Rectal tenesmus
Maltese: Tenesmus tar-rektum
English: Paraesthesia
Maltese: Paraestesja
English: Meda Pharma SIA Žalgirio str. 92, #2 Vilnius LT-09303 Tel. + 370 52059367
Maltese: Žalgirio str. 92, #2 Vilnius LT-09303 Tel.
English: (3x/wk, 4 or 8 wks) N = 252
Maltese: (3x/ ġmgħ,16ġmgħ) N = 2292
English: External genital warts in adults:
Maltese: Sinjali esterni ta' felul fl-adulti:
English: Some systemic adverse reactions, including headache (3.7%), influenza-like symptoms (1.1%), and myalgia (1.5%) were also reported.
Maltese: Xi reazzjonijiet sistemiċi avversi, li jinkludu uġigħ ta' ras (3.7%), sintomi ta' linfluwenza (1.1%), u milaġja (1.5) ġew rapportati wkoll.
English: Methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed).
Maltese: Methyl hydroxybenzoate (E218) u propyl hydroxybenzoate (E216) jistgħu jikkawżaw reazzjonijiet allerġiċi (possibilment tardjati).
English: Superficial basal cell carcinoma (5x/wk, 6 wks) N = 185
Maltese: Karċinoma superfiċjali taċċellola bażali (5x/ġmgħ, 6 ġmgħ)
English: Increases in systemic levels of alpha interferon and other cytokines following topical application of imiquimod were demonstrated in a pharmacokinetic study.
Maltese: Żidied fil-livelli sistematiċi t'alpha interferon u ċitokoni oħra wara applikazzjoni topikali ta' imiquimod ġew murija fi studju farmakokinetiku.
English: 75008 Paris Tél: +33 (0)1 56 64 10 70
Maltese: Tél: +33 (0)1 56 64 10 70
English: Each sachet contains 250 mg cream (100 mg cream contains 5 mg imiquimod).
Maltese: Kull qartas fih 250 mg krema (100 mg krema fiha 5 mg imiquimod).
English: • Warts (condylomata acuminata) on the surface of the genitals (sexual organs) and around the anus (back passage)
Maltese: • Felul (condylomata acuminata) fuq il-wiċċ tal-ġenitali (organi sesswali) u madwar l-anus (ilpassaġġ ta' wara)
English: Pharmacotherapeutic group: Chemotherapeutics for topical use, antivirals, ATC Code: D06BB10
Maltese: Kemoterapewtiċi għall-użu topiku, antivirali, Kodiċi ATC:
English: Five -year data from a long-term open-label uncontrolled study indicate that an estimated 77.9% [95% CI (71.9%, 83.8%)] of all the subjects who initially received treatment became clinically clear and remained clear at 60 months.
Maltese: Dejta ta hames snin minn studju mingħajr kontrolli b'tikketta li tidher tindika stima ta' 77.9% [95% CI (71.9%, 83.8%)] tal-pazjenti kollha li inizjalment bdew it-trattament saru klinikament ċari u baqgħu ċari wara 60 xahar.
English: Excipients: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E 218), propyl hydroxybenzoate (E 216), xanthan gum, purified water.
Maltese: Eċċipjenti: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E 218), propyl hydroxybenzoate (E 216), xanthan gum, ilma ppurifikat.
English: In 119 imiquimod-treated female patients, the combined total clearance rate was 60% as compared to 20% in 105 vehicle-treated patients (95% CI for rate difference: 20% to 61%, p<0.001).
Maltese: F'119-il pazjent mara ttrattati bl-imiquimod, ir-rata totali kkombinata ta' eliminazzjoni kienet ta' 60% meta mqabbla ma 20% f'105 pazjenti trattati bil-vettura (95% CI ghad-differenza tar-rata: 20% sa 61%, p<0.001).
English: 3.3%); and 66.7% (84 of 126 patients) for a treatment with imiquimod and 73.8% (62 of 84 patients) for topical diclofenac until month 36, a difference of -7.1% (95% CI: -19.0% to 5.7%).
Maltese: 3% (CI ta' 95%: -23.6% sa 3.3%); u 66.7% (84 minn 126 pazjent) għal trattament b'imiquimod u 73.8% (62 minn 84 pazjent) għal diclofenac topiku sa xahar 36, differenza ta' -7.
English: Regarding the primary endpoint, histological progression, overall 13 of 242 patients (5.4%) of the imiquimod group and 26 of 237 patients (11.0%) of the diclofenac group were found to have a histological progression to in situ or invasive SCC within 3 years, a difference of -5.6% (95% CI: -10.7% to -0.7%).
Maltese: Rigward il-punt finali primarju, il-progressjoni istoloġika, b'kollox 13 minn 242 pazjent (5.4%) talgrupp ta' imiquimod u 26 minn 237 pazjent (11.0%) tal-grupp ta' diclofenac instabu li kellhom progressjoni istoloġika għal SCC in situ jew invażiva fi żmien 3 snin, differenza ta' -5.6% (CI ta' 95%: -10.7% sa -0.7%).
English: Marketing Authorisation Holder Meda AB
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Meda AB
English: Imiquimod cream is indicated for the topical treatment of:
Maltese: Il-krema imiquimod hi indikata għat-trattament topiku ta':
English: Superficial basal cell carcinoma in adults:
Maltese: Karċinoma superfiċjali taċ-ċellula bażali f'adulti:
English: These protocol mandated clinical sign assessments indicate that local skin reactions including erythema (61%), erosion (30%), excoriation/flaking/scaling (23%) and oedema (14%) were common in these placebo controlled clinical trials with imiquimod cream applied three times weekly (see section 4.4).
Maltese: Dawn l-istimi tas-sinjali kliniċi obbligati bi protokoll jindikaw li r-reazzjonijiet lokali fuq il-ġilda li jinkludu eritema (61%), tnawwir (30%), sliħ/sfoll/qxur (23%) u edema (14%) kienu komuni f'dawn il-provi kliniċi kontrollati bi plaċebo bil-krema imiquimod applikata tliet darbiet fil-ġimgħa (ara sezzjoni 4.4).
English: Data from an open label clinical trial suggest that large tumours (>7.25 cm 2) are less likely to respond to imiquimod therapy.
Maltese: Dejta minn prova klinikika b'tikketta tidher tissuġerixxi li tumuri kbar (>7.25 ċm2) probabbli li jirrispondu inqas għal terapija b' imiquimod.
English: Local skin reactions, such as erythema, are probably an extension of the pharmacologic effects of imiquimod cream.
Maltese: Reazzjonijiet tal-ġilda lokali, bħal eritema, huma probabilment estensjoni ta' l-effetti farmakoloġiċi tal-krema imiquimod.
English: • External genital and perianal warts (condylomata acuminata) in adults.
Maltese: • Felul li jinsab fil-parti esterna tal-partijiet ġenitali u madwar il-parti anali (condylomata acuminata) f'adulti.
English: Commonly some patients (4% or less) have experienced headache, uncommonly fevers and flu like symptoms joint and muscle pains; prolapse of the womb; pain on intercourse in females; erection difficulties; increase in sweating; feeling sick; stomach and bowel symptoms; ringing in the ears; flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; loss of appetite; swollen glands; bacterial, viral and fungal infections (e.g. cold sores); vaginal infection including thrush; cough and colds with sore throat.
Maltese: Huwa komuni li xi pazjenti (4% jew inqas) kellhom uġigħ ta' ras, deni, uġigħ tal-ġogi u l-muskoli f'sintomi bħal ta' l-influwenza; prolass tal-ġuf; uġigħ waqt l-att fin-nisa; impotenza; żieda fl-għaraq; tħossok ma tiflaħx, sintomi ta' l-istonku u ta' l-imsaren, ċenċil fil-widnejn; għejja; sturdamenti, migranja; tingiż u labar; nuqqas ta' rqad; dipressjoni; nuqqas t'aptit; glandoli minfuħa, infezzjonijiet batteriċi, virali u fungali (e.g. ponot); infezzjoni vaġinali li tinkludi thrush; sogħla u irjaħat fl-uġigħ fil-griżmejn.
English: Serious skin reactions reported from postmarketing experience include erythema multiforme, Stevens Johnson syndrome and cutaneous lupus erythematosus.
Maltese: Kien hemm rapporti ta' reazzjonijiet serji tal-ġilda millesperjenza ta' wara t-tqegħid fis-suq dwar erythema multiforme, is-sindromu ta' Stevens Johnson u lupus eritematosi kutanea.
English: Systemic exposure (percutaneous penetration) was calculated from recovery of carbon-14 from 14C imiquimod in urine and faeces.
Maltese: Espożizzjoni sistemika (penetrazzjoni perkutanea) ġiet ikkalkulata bl-irkupru ta' karbonju-14 14C imiquimod fl-urina u l-ippurgar.
English: België/Belgique/Belgien Mylan EPD bvba/sprl Terhulpsesteenweg, 6A B-1560 Hoeilaart Tél/Tel: +32 2 658 61 00
Maltese: België/Belgique/Belgien Mylan EPD bvba/sprl Terhulpsesteenweg, 6A
English: In 157 imiquimod-treated male patients, the combined total clearance rate was 23% as compared to 5% in 161 vehicle-treated patients (95%CI for rate difference: 3% to 36%, p<0.001).
Maltese: F'157 pazjent raġel ittrattat bl-imiquimod, ir-rata totali kkombinata ta' tneħhija kienet ta' 23% meta mqabbla ma 5% f'161 pazjent trattat bil-vettura (95% CI ghad-differenza tar-rata: 3% sa 36%, p<0.001).
English: b) Tabular Listing of adverse events:
Maltese: b) Każijiet avversi elenkati f'tabella:
English: Peak serum drug concentrations at the end of week 16 were observed between 9 and 12 hours and were 0.1, 0.2, and 1.6 ng/mL for the applications to face (12.5 mg, 1 single-use sachet), scalp (25 mg, 2 sachets) and hands/arms (75 mg, 6 sachets), respectively.
Maltese: L-ogħla konċentrazzjonijiet tal-mediċina fis-sirum fl-aħħar ta' ġimgħa 16 kienu osservati bejn 9 u 12-il siegħa wara u kienu 0.1, 0.2, u 1.6 ng/mL għall-applikazzjonijiet fuq il-wiċċ (12.5 mg, qartas 1 li jintuża darba), il-qorriegħa (25 mg, 2 qratas) u l-idejn/dirgħajn (75 mg, 6 qratas), rispettivament.
English: d) Adverse events applicable to all indications:
Maltese: d) Reazzjonijiet avversi applikabbli għall-indikazzjonijiet kollha:
English: Aldara 5% cream Imiquimod
Maltese: Aldara 5% krema Imiquimod
English: Aldara 5% cream imiquimod
Maltese: ALDARA 5% krema Imiquimod
English: The pharmacokinetic properties of imiquimod following single and multiple topical application in paediatric patients with molluscum contagiosum (MC) have been investigated.
Maltese: Il-karatteristici tal-farmakokinetika ta` “imiquimod” f`pazjenti pedjatrici bill-molluskum kontagjosum (MK) gew investigati.
English: Thereof 4 of 242 patients (1.7%) of the imiquimod and 7 of 237 patients (3.0%) of the diclofenac group were found to have a histological progression to invasive SCC within the 3-year period.
Maltese: Minn dawn 4 minn 242 pazjent (1.7%) mill-grupp ta' imiquimod u 7 minn 237 pazjent (3.0%) mill-grupp ta' diclofenac instabu li kellhom progressjoni istoloġika għal SCC invażiva fil-perjodu ta' 3 snin.
English: (approx. 4 square inches).
Maltese: (madwar 4 pulzieri kwadri).
English: - The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E 218), propyl hydroxybenzoate (E 216), xanthan gum, purified water (see also section 2 “Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol”).
Maltese: - Is-sustanzi l-oħra huma isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E 218), propyl hydroxybenzoate (E 216), xanthan gum, ilma purifikat (ara wkoll sezzjoni 2 “Il-krema Aldara fiha methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol u benzyl alcohol”).
English: Luxembourg/Luxemburg Mylan EPD bvba/sprl Terhulpsesteenweg, 6A B-1560 Hoeilaart Tél/Tel: +32 2 658 61 00
Maltese: Luxembourg/Luxemburg Mylan EPD bvba/sprl Terhulpsesteenweg, 6A
English: Remote site skin reactions, mainly erythema (44%), were also reported in the placebo controlled trials.
Maltese: Reazzjonijiet tal-ġilda f'sit remot, prinċipalment eritema (44%), kienu wkoll rapportati fi provi kliniċi kontrollati bi plaċebo.
English: For imiquimod no clinical data on exposed pregnancies are available.
Maltese: Għal imiquimod m'hemmx dejta klinika fuq tqalat esposti.
English: Interactions with systemic drugs would be limited by the minimal percutaneous absorption of imiquimod cream.
Maltese: Dawn linterazzjonijiet mal-mediċini sistemiċi jkunu limitati bl-assorbiment perkutaneju minimu tal-krema imiquimod.
English: 6.1 List of excipients isostearic acid benzyl alcohol cetyl alcohol stearyl alcohol white soft paraffin polysorbate 60 sorbitan stearate glycerol methyl hydroxybenzoate (E 218) propyl hydroxybenzoate (E 216) xanthan gum purified water.
Maltese: 6.1 Lista ta' eċċipjenti isostearic acid benzyl alcohol cetyl alcohol stearyl alcohol white soft paraffin polysorbate 60 sorbitan stearate glycerol methyl hydroxybenzoate (E 218) propyl hydroxybenzoate (E 216) xanthan gum ilma ppurifikat
English: Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Maltese: Cetyl alcohol u stearyl alcohol jistgħu jikkaġunaw reazzjonijiet lokali tal-ġilda (eż. dermatite tal-kuntatt).
English: Aldara Cream has been evaluated in four randomised, vehicle controlled, double-blind trials in children aged 2 to 15 years with molluscum contagiosum (imiquimod n = 576, vehicle n = 313).
Maltese: Il-krema Aldara giet evalwata f`erbgha studji ikkontrollati bla ghazla, “vehicle controlled” “double blind” fuq tfal bejn is- 2-15 il-sena bil molluskum kontagjosum (imiquimod n=576, vettura n=313).
English: Patient reported adverse reactions from 2292 patients treated with imiquimod cream in placebo controlled and open clinical studies are presented below.
Maltese: Reazzjonijiet avversi rapportati mill-pazjenti minn 2292 pazjenti trattati bil-krema imiquimod fi studji kontrollati bi plaċebo u studji kliniċi miftuħa huma preżentati hawn isfel.
English: Face oedema
Maltese: Ħedla
English: Imiquimod cream was evaluated in a photocarcinogenicity bioassay in albino hairless mice exposed to simulated solar ultraviolet radiation (UVR).
Maltese: Il-krema imiquimod kienet evalwata b'bijoassaġġ ta' fotokarsinoġeniċità fi ġriedem albino mingħajr xagħar li ġew esposti għal radjazzjoni ultravjola solari (UVR).
English: Bacterial infection
Maltese: Infezzjoni batterika
English: Information applicable to all indications:
Maltese: Informazzjoni applikabbli għall-indikazzjonijiet kollha:
English: Lethargy
Maltese: Tqallih
English: Frequencies are defined as Very common (1/10), Common (1/100 to <1/10) and Uncommon (1/1,000 to <1/100).
Maltese: Il-frekwenzi huma mfissra bħala Komuni ħafna (≥ 1/10), Komuni (≥1/100 sa <1/10) u Mhux komuni (≥1/1,000 sa <1/100).
English: Other medicines and Aldara cream
Maltese: Mediċini oħra u krema Aldara
English: A different therapy is recommended if the treated lesion(s) shows insufficient response to Aldara.
Maltese: Hija rakkomandata terapija differenti jekk il-leżjoni(jiet) ittrattata(i) turi(juru) rispons insuffiċjenti għal Aldara.
English: Vaginitis
Maltese: Astenja
English: In a follow-up of 162 patients five years after treatment for sBCC a mild hypopigmentation was observed in 37% of the patients and a moderate hypopigmentation was observed in 6% of the patients.
Maltese: Tkomplija ta` studju fuq 162 pazjent hames snin wara trattament ghal sBCC ipopigmentazzjoni mhux severa gew osservati fi 37% tal-pazjenti w ipopigmentazzjoni moderata giet osservata f` 6% tal-pazjenti. 56% tal-pazjenti ma urewx ipopigmentazzjoni, iperpigmentazzjoni ma gietx irrapotata.
English: There is clinical experience from 90 patients who got 3 or more imiquimod treatment cycles, 80 patients received 5 or more courses of imiquimod treatment over the 3-year study period.
Maltese: Hemm esperjenza klinika minn 90 pazjent li rċevew 3 ċikli jew aktar ta' trattament b'imiquimod, 80 pazjent li rċevew 5 ċikli jew aktar ta' trattament b'imiquimod matul il-perjodu ta' studju ta' 3 snin.
English: White to slightly yellow cream.
Maltese: Krema Krema bajda li tkanġi fl-isfar.
English: Uncommon Common
Maltese: Komuni ħafna Komuni
English: Actinic keratosis:
Maltese: Disturbi psikjatriċi:
English: In a pooled analysis of these two studies, histological clearance was noted in 82% (152/185) of patients.
Maltese: F'analiżi puljata ta' dawn l-istudji, it-tneħħija istoloġika ġiet innotata fi 82% (152/185) ta' pazjenti.
English: The efficacy of imiquimod 5 times per week for 6 weeks was studied in two double-blind vehicle controlled clinical trials.
Maltese: L-effikaċja ta' imiquimod li jingħata 5 darbiet fil-ġimgħa għal 6 ġimgħat kien studjat f'żewġ provi kliniċi double blind kontrollati.
English: See package leaflet for further information.
Maltese: Ara l-fuljett għal aktar informazzjoni.
English: Metabolism and nutrition disorders: Anorexia
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni:
English: Some systemic adverse reactions, including back pain (1.1%) and influenza-like symptoms (0.5%) were reported by imiquimod cream patients.
Maltese: Xi reazzjonijiet sistematiċi avversi, li jinkludu uġigħ fid-dahar (1.1%) u sintomi bħal ta' l-influwenza (0.5%) ġew rapportati f'pazjenti li użaw il-krema imiquimod.
English: Application site warmth
Maltese: Mhux applikabbli
English: Boxes of 12 or 24 single-use polyester/aluminium foil sachets, containing 250 mg of cream.
Maltese: Kaxxi ta' 12-il jew 24-il qartas li kull wieħed jintuża darba biss magħmul minn fojl talpolyester/aluminju, li fih hemm 250 mg ta' krema.
English: Slovenská republika MEDA Pharma spol.
Maltese: Slovenská republika MEDA Pharma spol. s. r.o.
English: The complete clearance rate (imiquimod minus placebo) for the combined trials was 46.1% (CI 39.0%,
Maltese: 4-8 leżjonijiet ta' kertosi aktinika ġew trattati.Ir-rata ta' tneħħija kompluta (imiquimod nieqes il-plaċebo) għal provi kombinati kienet ta' 46.1% (CI 39.0%, 53.1%).
English: Leave Aldara cream on the warts for 6 to 10 hours.
Maltese: Ħalli l-krema Aldara fuq il-felul għal bejn 6 sa 10 sigħat.
English: Eye disorders Conjunctival irritation
Maltese: Disturbi fl-għajnejn Irritazzjoni konġunktivali
English: Uncommonly some patients experience changes at the application site (bleeding, inflammation, discharge, sensitivity, swelling, small swollen areas in the skin, pins and needles, scabbing, scarring, ulceration or a feeling of warmth or discomfort), or inflammation of the lining of the nose, stuffy nose, flu or flu-like symptoms, depression, eye irritation, swelling of the eyelid, throat pain, diarrhoea, actinic keratosis, redness, swelling of the face, ulcers, pain in extremity, fever, weakness or shivering.
Maltese: Mhux komuni li xi pazjenti jħossu bidliet fis-sit t'applikazzjoni (fsada, infjammazzjoni, tisfija, sensitività, tinfiħ, tinfiħ żgħir f'partijiet tal-ġilda, tingiż u labar, sfoll, ċikatriċ, ulċerazzjoni jew sensazzjoni ta' sħana jew skonfort), jew infjammazzjoni tar-riti ta' l-imnieħer, imnieħer miżdud, influwenza jew sintomi bħal ta' l-influwenza, dipressjoni, irritazzjoni ta' l-għajnejn, tinfiħ tal-kappell ta' l-għajn, uġigħ tal-griżmejn, dijarea, keratosi aktinika, ħmura, tinfiħ tal-wiċċ, ulċeri, uġigħ flestrimitajiet, deni, debolezza jew tertir.
English: After 6 to 10 hours wash the area where Aldara cream was applied with mild soap and water.
Maltese: Wara 6 sa 10 sigħat aħsel l-erja fejn l-krema Aldara ġiet applikata bis-sapun ħafif u ilma.
English: Pregnancy
Maltese: Migranja
English: A total of 482 patients were included into the trials, of these 481 patients received study treatments, and of these 243 patients were treated with imiquimod and 238 patients with topical diclofenac.
Maltese: Total ta' 482 pazjent kienu inklużi fil-provi, minn dawn 481 pazjent irċevew trattamenti tal-istudju u minn dawn 243 kienu ttrattati b'imiquimod u 238 pazjent b'diclofenac topiku.
English: Musculoskeletal and connective tissue disorders:
Maltese: Disturbi muskolu-skeletriċi u tattessuti konnettivi
English: • Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.
Maltese: • Klinikament, keratożijiet aktiniċi (AKs) tipiċi, mhux iperkeratotiċi u mhux ipertrofiċi fuq ilwiċċ jew il-ġilda tal-qorriegħa tar-ras f'pazjenti adulti immunokompetenti meta d-daqs jew innumru ta' leżjonijiet jillimitaw l-effikaċja u/jew l-aċċettabilità ta' krijoterapija u għażliet ta' trattamenti topiċi oħrajn huma kontrindikati jew anqas adattati.
English: Clinical studies investigating the use of imiquimod for the treatment of actinic keratosis have detected a 0.4% (5/1214) frequency of alopecia at the treatment site or surrounding area.
Maltese: Studji kliniċi li jistħarrġu l-użu ta' imiquimod għat-trattament ta' keratosi aktinika rrivelaw frekwenza ta' 0.4% (5/1214) ta' alopeċja fis-sit ta' trattament taż-żona tal-madwar.
English: Patients had clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions on the balding scalp or face within a contiguous 25 cm treatment area.
Maltese: Il-pazjenti kellhom leżjonijiet ta' kertosi aktinika klinikament tipiċi, viżibbli, diskreti, li mhumiex iperkeratoniċi, li mhumiex ipertropiċi fuq il-qorriegħa li qed titfartas jew wiċċ fi ħdan 25 cm erja ta' trattament.
English: If the treated tumour shows an incomplete response, a different therapy should be used (see section 4.4).
Maltese: Jekk it-tumur trattat juri rispons inkomplet, għandha tintuża terapija differenti (ara sezzjoni 4.4).
English: When applied topically, systemic overdosage with imiquimod cream is unlikely due to minimal percutaneous absorption.
Maltese: Meta applikat topikament, doża sistematika eċċessiva bil-krema imiquimod mhux probabbli sseħħ minħabba assorbenza perkutanea minima.
English: Respiratory, thoracic and mediastinal disorders:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: The safety database in uncircumcised men treated with imiquimod cream three times weekly and carrying out a daily foreskin hygiene routine is less than 100 patients.
Maltese: Id-database tas-sigurtà, f'irġiel mhux ċirkonċiżi, trattati bil-krema imiquimod tliet darbiet fil-ġimgħa u li jaħslu l-prepuzju kuljum bħala rutina hija ta' inqas minn 100 pazjent.
English: Actinic keratosis
Maltese: TA' EĊĊIPJENTI
English: The risk for recurrence of AK lesions in the treated field (as defined above) was 39.7% (50 of 126 patients) until month 12 for patients treated with imiquimod compared with 50.0% (42 of 84 patients) for patients treated with topical diclofenac, a difference of -10.3% (95% CI: -23.6% to
Maltese: Ir-riskju ta' rikorrenza ta' leżjonijiet ta' AK fiż-żona ttrattata (kif definit hawn fuq) kien ta' 39.7% (50 minn 126 pazjent) sa xahar 12 għall-pazjenti ttrattati b'imiquimod meta mqabbla ma' 50.0% (42 minn 84 pazjent) għall-pazjenti ttrattati b'diclofenac topiku, differenza ta' -10.
English: Investigators of the placebo controlled clinical trials were required to evaluate protocol mandated clinical signs (skin reactions).
Maltese: Investigaturi tal-provi kliniċi kontrollati bi plaċebo kienu meħtieġa li jevalwaw sinjali kliniċi obbligati bi protokoll (reazzjonijiet tal-ġilda).
English: Superficial basal cell carcinoma:
Maltese: Karċinoma superfiċjali taċ-ċellula bażali:
English: Eczema
Maltese: FARMAĊEWTIKU
English: Rare reports have been received of exacerbation of autoimmune conditions.
Maltese: Waslu rapporti rari li kundizzjonijiet awtoimmuni ħraxu.