FrancophonIA/ELRC3.0 huggingface dataset:
English: Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment.
Maltese: Protopic huwa disponibbli f'żewġ qawwiet, Protopic 0.03% u Protopic 0.1% ingwent.
English: Skin burning, herpes simplex, alcohol intolerance (facial flushing or skin sensitivity after alcohol intake), skin tingling, hyperaesthesia, acne and fungal dermatitis occurred more often in the tacrolimus treatment group.
Maltese: Ħruq tal-ġilda, herpes semplex, intolleranza lejn l-akoħol (ħmura tal-wiċċ jew sensitività tal ġilda wara xorb alkoħoliku), tingiż tal-ġilda, iperaestesija, akne u dermatite tal-fungus seħħew aktar frekwenti fil-grupp b'trattament b'tacrolimus.
English: Protopic is available in two strengths (Protopic 0.03% and Protopic 0.1% ointment).
Maltese: Protopic hu disponibbli f'żewġ konċentrazzjonijiet (Protopic 0.03% u Protopic 0.1% ingwent).
English: Protopic 0.1% ointment tacrolimus monohydrate
Maltese: Protopic 0.1% ingwent tacrolimus monohydrate
English: Patients with atopic dermatitis treated with Protopic have not been found to have significant systemic tacrolimus levels.
Maltese: Ma nstabx li dawk il-pazjenti b'dermatite atopika kkurati bi Protopic kellhom livelli sistemiċi sinifikanti ta' tacrolimus.
English: Tel:+385 1 3778 770
Maltese: Remedia d.o.o. Tel:+385 1 3778 770
English: Do not use this medicine after the expiry date which is stated on the tube and carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tubu u ta' fuq il-kartuna wara EXP.
English: Package sizes: 10 g, 30 g and 60 g. Not all pack sizes may be marketed.
Maltese: Daqsijiet tal-pakkett: 10 g, 30 g, u 60 g.
English: The results in the control group were similar.
Maltese: Ir-riżultati fil-grupp ta' kontroll kienu simili.
English: The efficacy and safety of Protopic was assessed in more than 18,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
Maltese: Effikaċja klinika u sigurtà L-effikaċja u s-sigurtà ta' Protopic ġew evalwati f'aktar minn 18,500 pazjent ikkurati b'ingwent tacrolimus fi provi kliniċi ta' Fażi I sa Fażi
English: Vehicle Twice weekly (N=73)
Maltese: (N=73)
English: During this period all patients and control subjects (n=44) received a primary immunisation and a rechallenge with a protein-conjugate vaccine against Neisseria menigitidis serogroup C.
Maltese: Matul dan ilperjodu, il-pazjenti kollha u l-persuni tal-kontroll (n=44) irċivew immunizzazzjoni primarja u rechallenge b'tilqima bi proteina-konjugat kontra Neisseria meningitidis ta' serogrupp Ċ.
English: Protopic 0.03% ointment tacrolimus monohydrate
Maltese: Protopic 0.03% ingwent tacrolimus monohydrate
English: LEO Pharma S.p.A. Tel: +39 06 52625500
Maltese: Tel: +39 06 52625500
English: These symptoms are usually mild to moderate and generally go away within one week of using Protopic.
Maltese: Dawn is-sintomi normalment ikun minn ħfief sa moderati u ġeneralment jgħibu fi żmien ġimgħa minn meta jintuża Protopic.
English: How to store Protopic
Maltese: mingħajr kura bi Protopic.
English: Flare treatment
Maltese: IL-PRODOTT MEDIĊINALI
English: These may include monitoring of vital signs and observation of clinical status.
Maltese: Dan jista' jinkludi monitoraġġ tas-sinjali vitali u ħarsien tal-istat kliniku tal-pazjent.
English: Ointment A white to slightly yellowish ointment.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD ILPROVVISTA
English: 1 g of Protopic 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
Maltese: 1 g ta' Protopic 0.1% ingwent fih 1.0 mg ta' tacrolimus bħala tacrolimus monohydrate (0.1%).
English: The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period.
Maltese: L-ewwel punt tal-evalwazzjoni kienet iż-żona taħt il-kurva (AUC = area under the curve) tal-mEASI bħala perċentwali tal-valur bażi fuq it-tul tattrattament.
English: In animals, tacrolimus ointment suppressed inflammatory reactions in experimental and spontaneous dermatitis models that resemble human atopic dermatitis.
Maltese: F'annimali tacrolimus ingwent waqqaf l-infjammazzjoni f'każijiet ta' dermatite sperimentali u spontanji li kienu jixbhu d-dermatite atopika tal-bniedem.
English: One gram of Protopic 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
Maltese: Gramma waħda ta' Protopic 0.03% ingwent fiha 0.3 mg tacrolimus (bħala tacrolimus monohydrate).
English: In both adults and children with an average of 50% body surface area treated, systemic exposure (i.e. AUC) of tacrolimus from Protopic is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
Maltese: Fi kbar u fi tfal b'medja ta' 50% tal-ġilda trattata, l-esponiment fiċ-ċirkolazzjoni tad-demm (i.e. AUC) ta' tacrolimus minn Protopic hu madwar 30% inqas minn dak ta' mediċina immunosoppressiva li tingħata mill-ħalq lillpazjenti li kellhom trapjant ta' kilwa jew fwied.
English: Patients with atopic dermatitis are predisposed to superficial skin infections.
Maltese: Pazjenti b'dermatite atopika jista' jkollom ukoll infezzjoni superfiċjali tal-ġilda.
English: Protopic contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Maltese: Protopic fih butylhydroxytoluene (E321), li jista' jikkawża reazzjonijiet lokali tal-ġilda (eż. dermatite tal-kuntatt), jew irritazzjoni fl-għajnejn u fil-membrani mukużi.
English: Global Evaluation § Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck §§ higher values = greater improvement
Maltese: Kors ta' Kortikosterojdi applikat b'mod topiku = 0.1% hydrocortisone butyrate fuq it-tronk u lestremitajiet, 1% hydrocortisone acetate fuq il-wiċċ u fuq l-għonq
English: Protopic 0.03% ointment
Maltese: Protopic 0.03% ingwent
English: The response rate in the 0.1% tacrolimus group (71.6%) was significantly higher than that in the topical corticosteroid based treatment group (50.8%; p<0.001; Table 1).
Maltese: (71.6%) kienet aktar għolja minn dik tal-grupp li ngħata kortikosterojdi b'mod topiku (50.8%;
English: Adults and adolescents (16 years of age and above) Adult patients (16 years of age and above) should use Protopic 0.1% ointment.
Maltese: Għall-adulti (minn 16-il sena 'l fuq) Protopic hu disponibbli f'żewġ konċentrazzjonijiet (Protopic 0.03% u Protopic 0.1% ingwent).
English: Carcinogenicity
Maltese: FARMAĊEWTIKU
English: Protopic 0.1% ointment
Maltese: Protopic 0.1% ingwent
English: Patients may be at an increased risk of folliculitis, acne and herpes viral infections.
Maltese: Il-pazjenti jista' jkollhom ukoll riskju akbar ta' follikulite, akne u infezzjonijiet virali bil-herpes.
English: One gram of Protopic 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
Maltese: Gramma waħda ta' Protopic 0.1% ingwent fiha 1.0 mg tacrolimus (bħala tacrolimus monohydrate).
English: In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies.
Maltese: F'pazjenti bi trapjant, l-esponiment sistemiku fit-tul għall-immunosuppressjoni intensa wara għoti sistemika ta' inibituri kalċinewriniċi ġiet assoċjata ma' żieda fir-riskju li jiżviluppaw limfomi u malinjitajiet fil-ġilda.
English: In a six-month multicentre double-blind randomised trial, 0.1% tacrolimus ointment was administered twice-a-day to adults with moderate to severe atopic dermatitis and compared to a topical corticosteroid based regimen (0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck).
Maltese: It-trattament bi Protopic ġiet paragunata ma' trattament b'kortikosterojdi applikat b'mod topiku (0.1% hydrocortisone butyrate fuq it-tronk u l-estremitajiet, 1% hydrocortisone acetate fuq il-wiċċ u fuq l-għonq).
English: Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage)
Maltese: Intolleranza lejn ix-xorb alkoħoliku
English: The efficacy and safety of tacrolimus ointment in maintenance treatment of mild to severe atopic dermatitis was assessed in 524 patients in two Phase III multicentre clinical trials of similar design,
Maltese: L-effikaċja u s-sigurtà tal-ingwent tacrolimus fil-kura ta' manteniment ta' dermatite atopika ħafifa għal severa ġew evalwati fuq 524 pazjent f'żewġ provi kliniċi b'aktar minn ċentru wieħed ta' Fażi
English: Tacrolimus 0.03% Twice daily (N=210)
Maltese: Tacrolimus 0.03% Darbtejn kuljum (N=210)
English: The purpose of the third multicentre, double-blind, randomised study was the assessment of efficacy and safety of 0.03% tacrolimus ointment applied once or twice a day relative to twice daily administration of 1% hydrocortisone acetate ointment in children with moderate to severe atopic dermatitis.
Maltese: L-iskop tat-tielet studju tat-tip double-blind li fih il-pazjenti ntgħażlu b'mod każwali, li ġie magħmul f'aktar minn ċentru wieħed, kienet l-evalwazzjoni tal-effikaċja u tas-sigurtà ta' 0.03% tacrolimus ingwent, li ġie applikat darba jew darbtejn kuljum fi tfal li kellhom dermatite atopika, moderata għal qalila, f'paragun ma' 1% ingwent tal-hydrocortisone acetate li ġie applikat darbtejn kuljum.
English: Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopic ointment is not recommended.
Maltese: Għalkemm informazzjoni klinika wriet li espożizzjoni sistemika mill-applikazzjoni tal-ingwent tacrolimus hi baxxa, it-treddigħ matul il-kura bi Protopic ingwent mhuwiex rakkomandat.
English: The results of this multicentre, double-blind, randomised trial showed that tacrolimus ointment, 0.03% and 0.1%, is significantly more effective (p<0.001 for both) than 1% hydrocortisone acetate ointment (Table 2).
Maltese: Ir-riżultati ta' din il-prova double-blind u li fih il-pazjenti ntgħażlu b'mod każwali, urew li tacrolimus ingwent f'konċentrazzjoni ta' 0.03% u ta' 0.1% hu sinifikament aktar effettiv (p<0.
English: In patients using tacrolimus ointment, cases of malignancies, including cutaneous (i.e. cutaneous T Cell lymphomas) and other types of lymphoma, and skin cancers have been reported (see section 4.8).
Maltese: F'pazjenti li jużaw lingwent tacrolimus, kien hemm rapportati każi ta' malinjitajiet, inklużi l-limfoma fil-ġilda (jigifieri limfoma tac-cellula tip T) u tipi oħra ta' limfoma, kif ukoll kanċer tal-ġilda (ara sezzjoni 4.8).
English: Impetigo, a superficial bacterial skin infection that usually produces blisters or sores on skin, has been reported in children.
Maltese: Impetigo, infezzjoni superfiċjali batterjali tal-ġilda li normalment tipproduċi infafet jew feriti fuq il-ġilda, kienet irrappurtata fit-tfal.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPIC 0.03% OINTMENT (10 g TUBE)
Maltese: Ż-ŻGĦAR EWLENIN PROTOPIC 0.03% INGWENT (10 g TUBU)
English: • If you have an inherited skin barrier disease such as Netherton's syndrome, lamellar ichthyosis (extensive scaling of the skin due to a thickening of the outer layer of the skin), or if you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire skin).
Maltese: • Jekk għandek marda ereditarja fil-funzjoni protettiva tal-ġilda bħas-sindrome ta' Netherton, iktijożi lamellari (formazzjoni estensiva ta' qoxra fil-ġilda minħabba tħaxxin tas-saff ta' barra tal-ġilda) jew jekk tbati minn eritroderma ġeneralizzata (ħmura infjammatorja u l-ġilda kollha titqaxxar).
English: EU/1/02/201/003 EU/1/02/201/004 EU/1/02/201/006
Maltese: EU/1/02/201/003 EU/1/02/201/004
English: Tacrolimus 0.03% Once daily (N=207)
Maltese: Tacrolimus 0.03% Darba kuljum (N=207)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPIC 0.1% OINTMENT (10 g TUBE)
Maltese: Ż-ŻGĦAR EWLENIN PROTOPIC 0.1% INGWENT (10 g TUBU)
English: The primary endpoint of this study was the response rate to vaccination, defined as the percentage of patients with a serum bactericidal antibody (SBA) titre ≥ 8 at the week 5 visit.
Maltese: Il-punt aħħari primarju ta' dan l-istudju kienet ir-rata ta' rispons għat-tilqima, definit bħala perċentwali ta' pazjenti b'titre ta' antikorp għas-serum batteriċidjali (SBA) ≥ 8 fil-viżta ta' ġimgħa 5.
English: Ophthalmic Herpes Infection*
Maltese: Infezzjoni talHerpes fl għajnejn*
English: Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Maltese: Il-kura ta' dermatite atopika moderata għal severa għall-prevenzjoni ta' ħmura tal-ġilda u t-titwil ta' intervalli mingħajr ħmura tal-ġilda f'pazjenti li jesperjenzaw frekwenza għolja ta' aggravar tal-marda (jiġifieri li sseħħ 4 drabi jew aktar fis-sena) li kellhom rispons inizjali għal massimu ta' 6 ġimgħat kura b'ingwent tacrolimus darbtejn kuljum (il-leżjonijiet għebu, kważi ġew eliminati jew ġew affettwati b'mod ħafif).
English: Thereafter, patients are considered suitable for maintenance treatment (see below).
Maltese: Wara, il-pazjenti jkunu kkunsidrati li huma adattati għal kura ta' manteniment (ara hawn taħt).
English: The use of tacrolimus ointment is not recommended in patients with a skin barrier defect, such as Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease.
Maltese: L-użu ta' tacrolimus ingwent mhux rakkomandat f'pazjenti li jsofru minn difett li jaffettwa l-ilqugħ tal-ġilda bħal sindromu ta' Netherton, iktijożi lamellari, eritroderma ġeneralizzata jew Graft Versus
English: An interaction study with protein-conjugated vaccine against Neisseria menigitidis serogroup C has been investigated in children aged 2-11 years.
Maltese: Popolazzjoni pedjatrika Studju ta' interazzjoni b'tilqima bi proteina-konjugat kontra Neisseria meningitidis ta' serogrupp Ċ
English: After 12 months this evaluation should include suspension of Protopic treatment in paediatric patients (see section 4.2).
Maltese: Wara 12-il xahar din l-evalwazzjoni għandha tinkludi sospensjoni tal-kura Protopic f'pazjenti pedjatriċi (ara sezzjoni 4.2).
English: Protopic ointment contains butylhydroxytoluene (E321) as an excipient, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Maltese: L-ingwent Protopic fih butylhydroxytoluene (E321) bħala eċċipjent, li jista' jikkawża reazzjonijiet lokali fil-ġilda (eż dermatite tal-kuntatt), jew irritazzjoni fl-għajnejn u fil-membrani mukużi.
English: Twice daily treatment with 0.03% tacrolimus ointment was more effective than once daily administration (Table 3).
Maltese: It-trattament darbtejn kuljum b'0.03% tacrolimus ingwent kien aktar effettiv millapplikazzjoni ta' darba kuljum (Tabella 3).
English: Between applications there should be 2-3 days without Protopic treatment.
Maltese: Għandu jkun hemm 2 - 3 ijiem bejn l-applikazzjonijiet,
English: Protopic 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Maltese: L-ingwent Protopic 0.1% jintuża biex jikkura dermatite atopika moderata sa severa (ekżema) fil-kbar li ma jkunux adegwatament responsivi għal jew intolleranti mill-kuri konvenzjonali bħala ma huma il kortikosterojdi topikali.
English: Package leaflet: Information for the user Protopic 0.03% ointment tacrolimus monohydrate
Maltese: Informazzjoni għall-utent Protopic 0.03% ingwent tacrolimus monohydrate
English: The primary endpoint in both studies was the number of disease exacerbations requiring a “substantial therapeutic intervention” during the DCP, defined as an exacerbation with an IGA of 3-5 (i.e. moderate, severe and very severe disease) on the first day of the flare, and requiring more than 7 days treatment.
Maltese: Il-punt ta' tmiem primarju fiż-żewġ studji kien in-numru ta' taħrixiet tal-mard li ħtieġu “intervent terapewtiku sostanzjali” matul id-DCP, definita bħala taħrixa b'IGA ta' 3 - 5 (jiġifieri marda moderata, severa u severa ħafna) fl-ewwel jum tal-ħmura tal-ġilda, u li ħtieġu aktar minn 7 ijiem kura.
English: Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 or more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by using Protopic 0.03% ointment twice weekly.
Maltese: La darba dermatite atopika moderata gћal severa tkun għebet jew tkun kważi għebet wara kura ta' mhux aktar minn 6 ġimgħat ta' ħmura tal-ġilda, u jekk qiegħed tesperjenza ħmura tal-ġilda frekwenti (jiġifieri 4 jew aktar fis-sena), jista' jkun possibbli li timpedixxi milli l-ħmura tal-ġilda tirritorna jew inkella tista' ttawwal iż-żmien li tkun ħieles minn ħmura tal-ġilda billi tuża ingwent Protopic 0.03%
English: Both studies showed significant benefit with twice weekly treatment with tacrolimus ointment with regard to the primary and key secondary endpoints over a period of 12 months in a pooled population of patients with mild to severe atopic dermatitis.
Maltese: Qabel ma tibda trattament bi Protopic ingwent, wieħed għandu jara li infezzjoni tal-ġilda fil-partijiet rilevanti tiġi mfejqa qabel.
English: • skin tingling
Maltese: minn fejn jingħata
English: • facial flushing or skin irritation after drinking alcohol is also common
Maltese: • fwawar tal-wiċċ jew irritazzjoni tal-ġilda wara li tixrob l-alkoħol huma wkoll komuni
English: Erythema was a common skin irritation adverse reaction.
Maltese: Eritema kienet reazzjoni ta' irritazzjoni avversa tal-ġilda komuni wkoll.
English: Protopic 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids.
Maltese: L-ingwent Protopic 0.03% jintuża biex jikkura dermatite atopika moderata sa severa (ekżema) fil-kbar li ma jkunux adegwatament responsivi għal jew intolleranti mill-kuri konvenzjonali bħala ma huma ilkortikosterojdi topikali u fit-tfal (ta' sentejn jew akbar) li kura konvenzjonali bħalma huma ilkortikosterojdi topikali ma ħadmitx fuqhom biżżejjed.
English: Systemic exposure from topical application of tacrolimus ointment is low (< 1.0 ng/ml) and is unlikely to be affected by concomitant use of substances known to be inhibitors of CYP3A4.
Maltese: Ilkonċentrazzjoni ta' tacrolimus fid-demm wara użu fuq il-ġilda hi baxxa (inqas minn 1.0 ng/mL) u għalhekk ma tiġix affettwata minn sustanzi kontra CYP3A4.
English: Long-term topical treatment of rats with tacrolimus led to systemic toxicity including alterations of kidneys, pancreas, eyes and nervous system.
Maltese: Meta tacrolimus ingħata fit-tul fuq il-ġilda tal-firien, dawn kellhom sinjali ta' tossiċità fis-sistema ġenerali b'tibdil fil-kliewi, pankrejas, għajnejn u s-sistema nervuża.
English: Since commercial availability a very small number of people who have used Protopic ointment have had malignancies (for example lymphoma, including skin lymphoma, and other skin tumours).
Maltese: Mindu sar jinxtara kummerċjalment numru żgħir ta' nies li użaw l-ingwent Protopic kellhom malinjitajiet (bħal limfoma, inkluż limfoma u tumuri oħra tal-ġilda).
English: A seven-month, double blind, randomised parallel group study of paediatric patients (2-11 years) with moderate to severe atopic dermatitis was performed.
Maltese: Sar studju li dam seba' xhur, double blind, li fih il-parteċipanti ntgħażlu b'mod każwali, grupp parallel, f'pazjenti pedjatriċi (minn sentejn sa 11-il sena) b'dermatite atopika minn moderata sa severa.
English: Package leaflet: Information for the user Protopic 0.1% ointment tacrolimus monohydrate
Maltese: Informazzjoni għall-utent Protopic 0.1% ingwent tacrolimus monohydrate
English: In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application.
Maltese: Madwar 50% tal-pazjenti kellhom xi tip ta' irritazzjoni avversa tal-ġilda fil-parti fejn ġie applikat l ingwent.
English: Uncommon (may affect fewer than 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw inqas minn 1 minn kull 100 persuna):
English: Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin with minimal diffusion into the systemic circulation.
Maltese: Meta tacrolimus ingwent jigi applikat lokalment, tacrolimus jgħaddi selettivament fil-ġilda, waqt li id diffużjoni fiċ-ċirkolazzjoni tad-demm hi minima.
English: Hard paraffin
Maltese: Killorglin
English: In the fourth trial, approximately 800 patients (aged ≥2 years) received 0.1% tacrolimus ointment intermittently or continuously in an open-label, long-term safety study for up to four years, with 300 patients receiving treatment for at least three years and 79 patients receiving treatment for a minimum of 42 months.
Maltese: 300 pazjent irċevew trattament għal mill-anqas 3 snin u 79 pazjent irċevew trattament għal mill-anqas 42 xahar.
English: Decrease (Primary Endpoint)§ Improvement ≥90% in Physician's Global Evaluation § higher values = greater improvement
Maltese: Titjib ≥ 90% fl-Evalwazzjoni globali tat-Tabib § valuri aktar baxxi = titjib akbar
English: In the comparator arm patients received 1% hydrocortisone acetate ointment (HA) for head and neck and 0.1% hydrocortisone butyrate ointment for trunk and limbs (n=111) twice a day for 2 weeks and subsequently HA twice a day to all affected areas.
Maltese: Fil-parti komparattiva tal istudju, il-pazjenti rċivew 1% hydrocortisone acetate ingwent (HA) għar-ras u l-għonq u 0.1% hydrocortisone butyrate ingwent għat-tronk tal-ġisem u d-dirgħajn/riġlejn (n=111) darbtejn kuljum għal ġimagħtejn u sussegwentement HA darbtejn kuljum għaż-żoni kollha affettwati.
English: § lower values = greater improvement
Maltese: Kura meta jkun hemm aggravament
English: • If you have a cutaneous Graft Versus Host Disease (an immune reaction of the skin which is a common complication in patients who have undergone a bone marrow transplant).
Maltese: • Jekk għandek Graft Versus Host Disease tal-ġilda (reazzjoni immunitarja tal-ġilda li hija kumplikazzjoni komuni f'pazjenti li għamlu trapjant tal-mudullun.
English: In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness, dryness).
Maltese: Fid-dermatite atopika, reazzjoni żejda tas-sistema immunitarja tal-ġilda toħloq infjammazzjoni tal ġilda (ħakk, ħmura, nixfa).
English: Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Maltese: Il-kura ta' dermatite atopika moderata għal severa fl-adulti li ma kellhomx rispons adegwat jew huma intolleranti għal terapiji konvenzjonali bħalma huma l-kortikosterojdi topikali.
English: The primary endpoint was the response rate at month 3 defined as the proportion of patients with at least 60% improvement in the mEASI (modified Eczema Area and Severity Index) between baseline and month 3.
Maltese: Il-punt aħħari primarju kienet ir-rispons kliniku wara tlett xhur, definita bħala il-proporz tal-pazjenti li għaddew għall-aħjar b' mill-anqas 60% skont l-mEASI (modified Eczema Area and Severity Index) bejn il-bidu talesperiment u kif skadew 3 xhur.