FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 9 February 2018 Date of latest renewal:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 9 ta' Frar, 2018
English: Hepatobiliary disorders
Maltese: Parametru Monoterapija
English:  Keep this leaflet.
Maltese: Proporzjoni ta' periklu kontra osservazzjoni
English: This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Maltese: Dan jagħti 21 mL ta' soluzzjoni għall-użu ta' darba, li fiha madwar 21 mg/mL ta' trastuzumab, b'pH ta' madwar 6.0.
English: There is no relevant use of Herzuma in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' Herzuma fil-popolazzjoni pedjatrika.
English:  Risk Management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP)
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Maltese: Dejjem żomm din il-mediċina fil-pakkett oriġinali magħluq f'temperatura ta' 2ºC - 8ºC fil-friġġ.
English: Early breast cancer (neoadjuvant-adjuvant setting)
Maltese: Kanċer bikri tas-sider (ambjent awżiljarju)
English: Tel.: + 48 22 417 9200
Maltese: EGIS Polska Sp. z o.o. Tel.: + 48 22 417 9200
English: In the BCIRG 006 study, trastuzumab was administered either in combination with docetaxel, following AC chemotherapy (AC→DH) or in combination with docetaxel and carboplatin (DCarbH).
Maltese: Fl-istudju BCIRG 006, trastuzumab ingħata flimkien ma' docetaxel, wara kimoterapija b'AC (AC→DH) jew flimkien ma' docetaxel u carboplatin (DCarbH).
English: Muscle tightness
Maltese: Ġilda xotta
English: 1) Using a sterile syringe, slowly inject 20 mL of water for injections in the vial containing the lyophilised Herzuma, directing the stream into the lyophilised cake.
Maltese: 1) Permezz ta' siringa sterili, injetta bil-mod 20 mL ta' ilma għall-injezzjonijiet fil-kunjett li fih
English: Hazard ratio vs AC→D (95% CI) p-value
Maltese: Proporzjon ta' Periklu kontra AC→D (CI ta' 95%) valur p
English: BATCH NUMBER
Maltese: Block 7
English: A volume overage of 4% ensures that the labelled dose of 420 mg can be withdrawn from each vial.
Maltese: Volum ta' 4% aktar jiżgura li d-doża mmarkata ta' 420 mg tkun tista' tittella' minn kull kunjett.
English: The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster nonlinear clearance (lower Km) (p < 0.001).
Maltese: L-analiżi esploratorja ta' kovarjabbli b'informazzjoni f'sottogrupp ta' pazjenti biss issuġġeriet li pazjenti b'livell ogħla ta' shed HER2-ECD kellhom tneħħija mhux lineari aktar malajr (Km aktar baxxa) (p < 0.001).
English: Patients treated with Herzuma are at increased risk for developing CHF (New York Heart Association [NYHA] Class II - IV) or asymptomatic cardiac dysfunction.
Maltese: Pazjenti kkurati b'Herzuma huma f'riskju akbar għall-iżvilupp ta' CHF (New York Heart Association [NYHA] Klassi
English: • asthma • infection of lungs
Maltese: • infezzjoni fil-pulmun
English: In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of trastuzumab with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant trastuzumab, up to total treatment duration of 1 year.
Maltese: F'ambjent ta' trattament neoawżiljarju-awżiljarju, l-istudju MO16432, prova li fiha l-parteċipanti ntgħażlu b'mod każwali b'aktar minn ċentru wieħed, kienet maħsuba biex tinvestiga l-effikaċja klinika ta' għoti ta' trastuzumab flimkien ma' kimoterapija neoawżiljarja inkluż kemm anthracycline kif ukoll taxane, segwit minn trastuzumab awżiljarju, sa tul ta' kura totali ta' sena.
English: In Study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the trastuzumab 1 year treatment arm was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%.
Maltese: III u IV) fil-grupp ta' kura bi trastuzumab għal sena waħda kienet ta' 0.8%, u r-rata ta' disfunzjoni ħafifa tal-ventrikolu tax-xellug bis-sintomi u bla sintomi kienet ta' 4.6%.
English: Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker.
Maltese: Jekk tiżviluppa insuffiċjenza sintomatika tal-qalb waqt terapija b'Herzuma, għandha tiġi kkurata bi prodotti mediċinali standard għal CHF. Il-biċca l-kbira tal-pazjenti li żviluppaw CHF jew disfunzjoni kardijaka bla sintomi fil-provi pivitali marru għall-aħjar b'kura standard għal CHF li tikkonsisti minn inibitur tal-enzima li tittrasforma lill-angiotensin (ACE - angiotensin-converting enzyme) jew imblokkatur tar-riċettur ta' angiotensin (ARB - angiotensin receptor blocker) u imblokkatur tarriċetturi beta.
English: Herzuma should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).
Maltese: Huwa meħtieġ ittestjar għal HER2 qabel tinbeda t-terapija (ara sezzjonijiet 4.4 u 5.1).
English: Each vial contains 420 mg trastuzumab that has to be dissolved in 20 mL of water for injection.
Maltese: Kull kunjett fih 420 mg trastuzumab li għandu jiġi mdewweb f'20 mL ta' ilma għall-injezzjoni.
English: Upper respiratory tract infection Common Urinary tract infection
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq Komuni Infezzjoni fl-apparat tal-awrina
English: B. PACKAGE LEAFLET
Maltese: Valur p kontra osservazzjoni
English: Reproduction studies have been conducted in Cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation and have revealed no evidence of impaired fertility or harm to the foetus.
Maltese: Twettqu studji dwar ir-riproduzzjoni f'xadini Cynomolgus b'dożi sa 25 darba aktar mid-doża ta' manteniment ta' kull ġimgħa għall-bnedmin, ta' 2 mg/kg ta' formulazzjoni għall-għoti ġol-vini ta' trastuzumab, u ma żvelaw l-ebda evidenza ta' tnaqqis fil-fertilità jew ħsara lill-fetu.
English: After reconstitution, 1 mL concentrate contains 21 mg of trastuzumab.
Maltese: Wara r-rikostituzzjoni 1 ml ta' konċentrat ikun fih 21 mg ta' trastuzumab.
English: The pre-planned final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831 was performed when 707 deaths had occurred (median follow-up 8.3 years in the AC→PH
Maltese: L-analiżi finali ppjanata minn qabel ta' OS mill-analiżi konġunta tal-istudji NSABP B-31 u NCCTG N9831 kienet imwettqa meta seħħew 707 imwiet (segwitu medjan ta' 8.3 snin fil-grupp ta' AC→PH).
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarised in Table 6:
Maltese: Ir-riżultati tal-effikaċja mill-prova BO16348 wara segwitu medjan ta' 12-il xahar* u ta' 8 snin** huma miġbura fil-qosor f'Tabella 6:
English: Each vial of Herzuma is reconstituted with 7.2 mL of water for injections (not supplied).
Maltese: Kull kunjett ta' Herzuma huwa rikostitwit b'7.2 mL ta' ilma għall-injezzjonijiet (mhux fornut).
English: Study M77001: Full analysis set (intent-to-treat), 24 months results
Maltese: Studju M77001:
English: No reactivity or membranous reactivity in < 10% of tumour cells
Maltese: L-ebda reattività jew reattività fil-membrana f' < 10% taċċelluli tat-tumur
English: In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of Herzuma, or longer if a continuous decrease of LVEF is observed.
Maltese: F'pazjenti li jirċievu kimoterapija li fiha anthracycline huwa rakkomandat aktar monitoraġġ, u dan għandu jseħħ kull sena sa 5 snin wara l-aħħar għoti ta' Herzuma, jew aktar jekk jiġi osservat tnaqqis kontinwu ta' LVEF.
English: Congestive heart failure (NYHA Class II - IV) is a common adverse reaction associated with the use of Herzuma and has been associated with a fatal outcome (see section 4.4).
Maltese: II - IV) hija reazzjoni avversa komuni assoċjata malużu ta' Herzuma u kienet assoċjata ma' riżultat fatali (ara sezzjoni 4.4).
English: Lip swelling
Maltese: Telf ta' Smigħ
English: Kern Pharma, S.L.
Maltese: Medical Logistics Ltd.
English: analysis DFS hazard ratios (95% CI) p-value p<0.0001
Maltese: Sopravivenza mingħajr marda Numru ta' pazjenti bl-avveniment (%) Metastasi p < 0.0001
English: Although there are some limitations when using Cairo-Bishop criteria for diagnosis leading to underestimation of the number of cases, the update of the Product Information to include TLS with a frequency unknown is endorsed, because trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Maltese: Minkejja li hemm xi limitazzjonijiet meta jintużaw il-kriterji ta' Cairo-Bishop għad-dijanjosi li jwasslu għal stima baxxa tan-numru ta' każijiet, l-aġġornament tal-Informazzjoni tal-Prodott biex tinkludi TLS bi frekwenza mhux magħrufa hija approvata, minħabba li trastuzumab huwa medjatur qawwi ta' ċitotossiċità medjata miċ-ċelluli dipendenti minn antikorpi (ADCC - antibody-dependent cell-mediated cytotoxicity).
English: Common Supraventricular tachyarrhythmia Common Cardiomyopathy
Maltese: Taki-arritmija supraventrikolari
English: After reconstitution
Maltese: Sopravivenza globali
English: For instructions on reconstitution of Herzuma intravenous formulation before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni tal-formulazzjoni għall-għoti ġol-vini ta' Herzuma qabel jingħata, ara sezzjoni 6.6.
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2:
Maltese: Istruzzjonijiet għar-rikostituzzjoni u d-dilwizzjoni:
English: The clinical relevance of these antibodies is not known.
Maltese: Ir-rilevanza klinika ta' dawn l-antikorpi mhix magħrufa.
English: Each vial of Herzuma is reconstituted with 20 mL of sterile water for injection (not supplied).
Maltese: Kull kunjett ta' Herzuma huwa rikostitwit b'20 mL ta' ilma għall-injezzjoni sterili (mhux ipprovdut).
English: Detection of HER2 over expression or HER2 gene amplification in gastric cancer
Maltese: II - IV) jew disfunzjoni kardijaka mhux sintomatika.
English: which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 30 - 60 minutes repeated every 3 weeks for a total of six cycles
Maltese: It-tnejn ingħataw ma': - cisplatin - 80 mg/m2 kull 3 ġimgħat għal 6 ċikli fl-ewwel ġurnata ta' kull ċiklu.
English: The median duration of follow up was 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm. Table 7 Summary of efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive DFS analysis*
Maltese: Sommarju ta' riżultati tal-effikaċja mill-analiżi konġunta tal-provi NSABP B-31 u NCCTG N9831 fil-ħin tal-analiżi definittiva ta' DFS
English: Herzuma is a powder for concentrate for solution for intravenous infusion, which is supplied in a glass vial with a rubber stopper containing 150 mg of trastuzumab.
Maltese: Herzuma huwa trab għal konċentrat għall-soluzzjoni għall-infużjoni ġol-vini, li huwa disponibbli f'kunjett tal-ħġieġ b'tapp tal-lastku li fih 150 mg ta' trastuzumab.
English: Erysipelas
Maltese: Stitikezza
English: Subsequent Herzuma maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Maltese: 6 mg/kg, rispettivament) għandhom jingħataw 7 ijiem jew 21 jum wara skont il-programmi ta' darba fil-ġimgħa jew ta' darba kull tliet ġimgħat, rispettivament.
English: This medicinal product must not be diluted with glucose solutions since these cause aggregation of the protein.
Maltese: Dan il-prodott mediċinali m'għandux jiġi dilwit b'soluzzjonijiet ta' glucose għaliex dawn jistgħu jikkawżaw aggregazzjoni tal-proteina.
English: Co. Kerry,
Maltese: Kerry,
English: Date of renewal: 20/11/2006
Maltese: Data ta' tiġdid ta' l-awtorizzazzjoni: 20/11/2006
English: Manufacturer: Astellas Ireland Co. Ltd., Killorglin, County Kerry, Ireland.
Maltese: Ltd., Killorglin, County Kerry, L-Irlanda.
English: LIST OF EXCIPIENTS white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin.
Maltese: white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28/02/2002
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 28/02/2002
English: Repeated dose toxicity and local tolerance
Maltese: Tossiċità minn dożi ripetuti u tolleranza lokali
English: Astellas Pharma Sp.z o.o.
Maltese: Astellas Pharma Sp.z o.o. ul.
English: Branch Erasmus Park/Parc Erasme Square Marie Curie 50
Maltese: Luxembourg/Luxemburg Astellas Pharma B.V. Branch Erasmus Park/Parc Erasme Square Marie Curie 50
English: Frequencies are defined as very common (> 1/10), common (> 1/100, < 1/10) and uncommon (> 1/1,000, < 1/100).
Maltese: Il-frekwenzi huma innutati bħala komuni ħafna (> 1/10), komuni (> 1/100, < 1/10) u mhux komuni (> 1/1,000, < 1/100).
English: SI-1000 Ljubljana Tel: +386 1 2364700
Maltese: Ljubljana Tel: +386 1 2364700
English: The active substance is tacrolimus monohydrate.
Maltese: Is-sustanza attiva hi tacrolimus monohydrate.
English: Herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption)
Maltese: Infezzjonijiet bil-herpes (dermatite b'herpes simplex [eczema herpeticum], herpes semplex [ħżiża], eruzzjoni variċelliforma ta' Kaposi)
English: Do not use Protopy
Maltese: X'fih Protopy
English: Via its binding to a specific cytoplasmic immunophilin (FKBP12), tacrolimus inhibits calciumdependent signal transduction pathways in T cells, thereby preventing the transcription and synthesis of IL-2, IL-3, IL-4, IL-5 and other cytokines such as GM-CSF, TNF-α and IFN-γ.
Maltese: Minħabba li tacrolimus jintrabat ma' immunophilin speċifiku taċ-ċellula (FKBP12), tacrolimus jinibixxi ġewwa T-cells sinjali tat-transduzzjoni, li jiddependu fuq il-kalċju, u b'hekk tiġi mwaqqfa ttranskrizzjoni u s-sinteżi ta' IL-2, IL-3, IL-4, IL-5, u ta' ċitokini oħra bħal GM-CSF, TNF-α u IFN-γ.
English: In vitro, in Langerhans cells isolated from normal human skin, tacrolimus reduced the stimulatory activity towards T cells.
Maltese: In vitro, f' ċelluli ta' Langerhans li nkisbu minn ġilda normali, tacrolimus naqqas l-attività stimulatorja lejn it-T cells.
English: The average total body clearance is approximately 2.25 l/h.
Maltese: Il-clearance totali mill-ġisem hi bejn wieħed u ieħor 2.25 l/h.
English: Do not pass it on to others.
Maltese: L-akne mhux effett komuni ta' Protopy.
English: Treatment with Protopy may be associated with an increased risk of herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption).
Maltese: Waqt it-trattament bi Protopy ir-riskju ta' infezzjoni bil-herpes (dermatite sempliċi tal-herpes [eczema herpeticum], herpes simplex [ħżiża], eruzzjoni variċelliforma ta' Kaposi).
English: Protopy 0.1% Ointment Tacrolimus monohydrate
Maltese: Protopy 0.1% ingwent Tacrolimus monohydrate
English: As systemic exposure is low with tacrolimus ointment, the high binding of tacrolimus (> 98.8%) to plasma proteins is considered not to be clinically relevant.
Maltese: Minħabba li meta tacrolimus ingwent ma jwassalx għal esponiment għoli fiċ-ċirkolazzjoni, l-irbit qawwi ta' tacrolimus (> 98.8%) mal-proteini tal-plażma mhuwiex meqjus bħala wieħed ta' rilevanza
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar il-mediċini (EMEA) http://www.emea.europa.eu
English: Uncommon:
Maltese: Manifattur:
English: Endpoint)§§
Maltese: {XX/SSSS}
English: Magyarország Astellas Pharma Kft.
Maltese: Magyarország Astellas Pharma
English: Pharmaswiss d.o.o.
Maltese: Pharmaswiss d.o.o. Wolfova 1
English: Protopy 0.03% Ointment Tacrolimus monohydrate
Maltese: Protopy 0.03% ingwent Tacrolimus monohydrate
English: Edifício Cinema Rua José Fontana, n.°1, 1°Andar P-2770-101 Paço de Arcos Tel: +351 21 4401320
Maltese: P-2770-101 Paço de Arcos Tel: +351 21 4401320
English: Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous interactions that could affect the metabolism of tacrolimus.
Maltese: Tacrolimus ma jiġiex metabolizzat fil-ġilda umana, u għalhekk m'hemmx periklu ta' interazzjoni fillivell tal-ġilda li jista' jaffettwa l-metaboliżmu ta' tacrolimus.
English: Astellas Pharma AB Haraldsgatan 5
Maltese: Haraldsgatan 5
English: The active substance of Protopy, tacrolimus monohydrate, is an immunomodulating agent.
Maltese: Is-sustanza attiva ta' Protopy, tacrolimus monohydrate, huwa aġent immuno-modulatorju.
English: Protopy contains the active substance tacrolimus, a calcineurin inhibitor.
Maltese: Protopy fih is-sustanza attiva tacrolimus, inibitur kalċinewriniku.
English: Following repeated topical application of the ointment the average half-life of tacrolimus was estimated to be 75 hours for adults and 65 hours for children.
Maltese: Meta l-ingwent jiġi applikat ripetutament il-medja tal-half life ta' tacrolimus kienet stmata li tkun 75
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: Global Evaluation § Corticosteroid applikat b'mod topiku = 0.1% hydrocortisone butyrate fuq is-sider, fuq iż-żaqq, fuq lidejn, fuq ir-riġlejn u fuq is-saqajn, 1% hydrocortisone acetate fuq il-wiċċ u fuq l-għonq §§ valuri aktar għoljin = titjib akbar
English: For live attenuated vaccinations (e.g. measles, mumps, rubella or oral polio) the waiting time is 28 days, for inactivated vaccines (e.g. tetanus, diphtheria, pertussis or influenza) 14 days.
Maltese: Għat-tilqim attiv (measels, mumps, rubella, jew polio li jittieħed mill-ħalq) wieħed jistenna 28 ġurnata u għat-tilqim inattiv (tetanu, diphteria, pertussis jew influwenza) wieħed jistenna 14-il ġurnata.
English: Pharmacotherapeutic group: Other dermatologicals, ATC code: D11AX14
Maltese: Prodotti mediċinali tal-ġilda, kodiċi ATC:
English: Most atopic dermatitis patients (adults and children) treated with single or repeated application of tacrolimus ointment (0.03 - 0.1%), and infants from age of 5 months treated with tacrolimus ointment (0.03%) had blood concentrations < 1.0 ng/ml.
Maltese: Ħafna mill-pazjenti li jbatu minn dermatite atopika (kbar u żgħar) kkurati b'applikazzjoni waħda jew ripetuta ta' ingwent tacrolimus (0.03 - 0.1%), kif ukoll trabi minn ħames xhur ikkurati bl-ingwent tacrolimus (0.03%) kellhom konċentrazzjonijiet fid-demm ta' < 1.0 ng/ml.
English: If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Protopy or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).
Maltese: Jekk int allerġiku (għandek sensitività eċċessiva) għal tacrolimus jew xi wieħed mill-ingredjenti oħra ta' Protopy jew ta' l- antibijotiċi macrolide (eż. azithromycin, clarithromycin,
English: The efficacy and safety of Protopy was assessed in more than 13,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
Maltese: L-effiċjenza u s-sigurtà ta' Protopy ġew studjati f' aktar minn 13,500 pazjent wara trattament bi Protopy ingwent fil Fasi I sa Fasi
English: Lymphadenopathy was uncommonly (0.8%) reported in clinical trials.
Maltese: Każijiet mhux komuni (0.8%) ta' limfadenopatija kienu rapurtati fi provi kliniċi.
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), tingiz tal-ġilda, hyperaesthesia, akne u dermatite tal-fungus seħħew aktar sikwit fil-grupp b' trattament b' tacrolimus.
English: PHARMACEUTICAL FORM Ointment
Maltese: TAL-PRODOTT MEDIĊINALI
English: RELEASE
Maltese: ISEM
English: Hypersensitivity to macrolides in general, to tacrolimus or to any of the excipients.
Maltese: Sensittività eċċessiva għal macrolides, għal tacrolimus jew għal xi sustanzi ohrajn.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
Maltese: U KWANTITATTIVA 1 g ta' Protopy 0.03% ingwent fih 0.3 mg ta' Tacrolimus bħala tacrolimus monohydrate (0.03%).
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: Ir-rata ta' rispons posittiv fil-grupp li ngħata 0.1% Tacrolimus (71.6%) kienet aktar għolja minn dik tal-grupp li ngħata corticosteroid b'mod topiku (50.8%; p<0.001;
English: Protopy ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Maltese: Is-sigurtà u l-effiċenza ta' Protopy ingwent għadhom ma ġewx eżaminati fit-trattament tad-dermatite atopika klinikament infettata.
English: However, the possibility of interactions cannot be ruled out and the concomitant systemic administration of known CYP3A4 inhibitors (e.g. erythromycin, itraconazole, ketoconazole and diltiazem) in patients with widespread and/or erythrodermic disease should be done with caution.
Maltese: Iżda wieħed ma jistgħax jeskludi lpossibiltà ta' interazzjoni u għalhekk hemm bżonn ta' attenzjoni fl-użu konkomitanti ta' sustanzi kontra CYP3A4 (erythromycin, itraconazole, ketoconazole u diltiazem) f' pazjenti li għandhom mard tal-ġilda mifrux ħafna u/jew f' pazjenti bil-marda eritrodermika.
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: OTHER
Maltese: INDIVIDWALI
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 randomised", li ġie magħmul f' aktar minn ċentru wieħed, kienet l-evalwazzjoni ta' l-effiċjenza 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: 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 jew severa fl-adulti li ma jkunux adegwatament responsivi għal jew intolleranti għal terapiji konvenzjonali bħalma huma l-kortikosterojdi topikali.
English: Protopy is available in two strengths (Protopy 0.03% and Protopy 0.1% ointment).
Maltese: Għal-kbar Protopy jinstab f'żewġ konċentrazzjonijiet (Protopy 0.03% u Protopy 0.1% ingwent).
English: One gram of Protopy 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
Maltese: Gramma waħda ta' Protopy 0.03% ingwent fiha 0.3 mg tacrolimus (bħala tacrolimus monohydrate).