FrancophonIA/ELRC3.0 huggingface dataset:
English: Rhokiinsa is supplied sterile in opaque white low density polyethylene bottles (2.5 ml fill in a 4 ml container) and tips with white polypropylene caps and anti-tamper seals.
Maltese: 2.5 ml f'kontenitur ta' 4 ml) u truf b'tappijiet bojod tal-polipropilen u siġilli kontra t-tbagħbis.
English: Warnings and precautions • Do not use Rhokiinsa more than once a day, as you may experience more side effects.
Maltese: • Tużax Rhokiinsa aktar minn darba kuljum, peress li tista' tesperjenza aktar effetti sekondarji.
English: Approximately 75% of subjects included in the netarsudil treatment groups of Phase 3 studies were Caucasian and 24% Black or African American.
Maltese: Kawkasi u 24 % Suwed jew Amerikani Afrikani.
English: The safety and efficacy of Rhokiinsa in children below the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Rhokiinsa fit-tfal taħt l-età ta' 18-il sena għadhom ma ġewx determinati.
English: Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Maltese: Benzalkonium chloride jista' jiġi assorbit minn lentijiet tal-kuntatt rotob u jista' jibdel il-kulur tal lentijiet tal-kuntatt.
English: Store in a refrigerator (2°C - 8°C) until opened.
Maltese: Aħżen fi friġġ (2°C - 8°C) sakemm jinfetaħ.
English: The majority of cornea verticillata resolved upon discontinuation of treatment.
Maltese: Il-maġġoranza tal-kornea vertikillata ġiet solvuta mat-twaqqif tat-trattament.
English: Frequency Adverse reactions instillation site erythema, instillation site discomfort, instillation site pruritis, vital dye staining cornea present, intraocular pressure increased
Maltese: ikun hemm preżenti kornea bi tbajja' talkulur vitali, tiżdied il-pressjoni intraokulari
English: Very common conjunctival hyperaemia1, cornea verticillata1, instillation site pain
Maltese: kornea vertikillata uġigħ fis-sit tal-instillazzjoni
English: Systemic exposure to netarsudil following topical ocular administration has been shown to be negligible.
Maltese: L-esponiment sistemiku għal netarsudil wara għoti okulari topiku ntwera li huwa negliġibbli.
English: No data on potential interactions specific to netarsudil is currently available (see section 4.5).
Maltese: Bħalissa m'hemm l-ebda data disponibbli dwar l-interazzjonijiet potenzjali speċifiċi għal netarsudil (ara sezzjoni 4.5).
English: Each bottle contains 2.5 ml of the medicine and each pack contains one bottle with a screw-cap.
Maltese: 2.5 ml tal-mediċina u kull pakkett fih flixkun wieħed b'tapp tal-kamin.
English: Completion rates in Phase 3 studies were lower in the netarsudil treatment group when compared with the timolol maleate group.
Maltese: Ir-rati ta' tlestija fl-istudji tal-Fażi 3 kienu aktar baxxi fil-grupp ta' trattament ta' netarsudil meta mqabbla mal-grupp ta' timolol maleate.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal
English: NAME OF THE MEDICINAL PRODUCT Rhokiinsa 200 micrograms/ml eye drops, solution.
Maltese: Rhokiinsa 200 mikrogramma/ml qtar tal-għajnejn, soluzzjoni.
English: Conjunctival hyperaemia was the most frequently reported adverse reaction associated with netarsudil treatment in clinical trials and it is attributed to the vasodilation effect of the Rho kinase inhibitor drug class.
Maltese: L-iperemija konġuntivali kienet ir-reazzjoni avversa l-aktar irrappurtata ta' spiss assoċjata mattrattament b'netarsudil fi provi kliniċi u hija attribwita għall-effett ta' vażodilatazzjoni tal-klassi ta' mediċina tal-inibitur ta' Rho kinażi.
English: Common conjunctival haemorrhage, vision blurred, lacrimation increased, erythema of eyelid, eye pruritis, eye irritation, visual acuity reduced, eyelid oedema, punctate keratitis, conjunctival oedema, foreign body sensation in eyes, conjunctivitis, conjunctivitis allergic, photophobia, eyelid pruritus, eye pain, corneal opacity, dry eye, eye discharge,
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni u effett tossiku fuq l-iżvilupp, ma juri l-ebda periklu speċjali għall-bnedmin.
English: How to store Rhokiinsa
Maltese: Mediċini oħra u Rhokiinsa
English: Treatment of an overdose would include supportive and symptomatic therapy.
Maltese: It-trattament ta' doża eċċessiva jinkludi terapija ta' appoġġ u sintomatika.
English: Netarsudil belongs to a group of medicines called “Rho kinase inhibitors”, which work to reduce the amount of fluid inside the eye and so lower its pressure.
Maltese: Netarsudil tappartjeni għal grupp ta' mediċini msejħa “inibituri tar-Rho kinażi”, li jaħdmu biex inaqqsu l-ammont ta' fluwidu ġewwa l-għajn u b'hekk inaqqsu l-pressjoni tiegħu.
English: Uncommon dermatitis allergic, dermatitis contact, lichenification, petechiae Musculoskeletal and connective tissue disorders Uncommon polychondritis Injury, poisoning and procedural complications Uncommon excoriation 1 See Description of selected adverse reactions for further information
Maltese: It-tarf tal-kontenitur tad-dispensar għandu jevita kuntatt mal-għajnejn, l-istrutturi tal-madwar, is swaba', jew kwalunkwe wiċċ ieħor sabiex tiġi evitata l-kontaminazzjoni tas-soluzzjoni.
English: Mannitol
Maltese: OĦRAJN
English: Rhokiinsa is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension.
Maltese: Rhokiinsa huwa indikat għat-tnaqqis ta' pressjoni intraokulari għolja (elevated intraocular pressure
English: A randomised, double-blind, multicentre Phase 3 clinical trial compared the efficacy and safety of netarsudil once daily with that of timolol maleate 0.5% twice daily in reducing IOP in a total of 708 patients with open-angle glaucoma or ocular hypertension.
Maltese: netarsudil darba kuljum ma' dik ta' timolol maleate 0.5 % darbtejn kuljum fit-tnaqqis tal-IOP f'total ta' 708 pazjenti bi glawkoma b'angolu miftuħ jew ipertensjoni okulari.
English: The efficacy and safety of netarsudil in subjects with compromised corneal epithelium or co-existing ocular pathologies e.g. pseudoexfoliation and dispersion pigment syndrome has not been established.
Maltese: Treddigħ Mhux magħruf jekk netarsudil/metaboliti humiex eliminati fil-ħalib tas-sider tal-bniedem.
English: No effects during pregnancy are anticipated, since systemic exposure to netarsudil is negligible (see section 5.2).
Maltese: Mhumiex antiċipati effetti matul it-tqala, peress li l-esponiment sistemiku għal netarsudil huwa negliġibbli (ara sezzjoni 5.2).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rhokiinsa 200 micrograms/ml eye drops netarsudil
Maltese: Rhokiinsa 200 mikrogramma/ml qtar tal-għajnejn netarsudil
English: If you are using other eye drops, wait at least five minutes after using them and then use Rhokiinsa.
Maltese: Jekk qed tuża qtar tal-għajnejn oħrajn, stenna mill-inqas ħames minuti wara li tużahom u mbagħad tuża Rhokiinsa.
English: Netarsudil dosed twice daily provided slightly larger IOP reductions, but had a less favorable safety profile as reflected in a higher rate and increased severity of ocular adverse reactions.
Maltese: Netarsudil ddożat darbtejn kuljum ipprovda tnaqqis tal-IOP kemxejn akbar, iżda kellu profil tas-sigurtà inqas favorevoli kif rifless f'rata ogħla u żieda fis-severità ta' reazzjonijiet avversi okulari.
English: Subjects with known contraindications or hypersensitivity to timolol were excluded from the studies.
Maltese: L-individwi b'kontraindikazzjonijiet magħrufa jew b'sensittività eċċessiva għal timolol ġew esklużi mill-istudji.
English: You may find that your vision is blurred or abnormal just after using Rhokiinsa.
Maltese: Tista' tinduna li l-vista tiegħek hija mċajpra jew anormali eżatt wara li tuża Rhokiinsa.
English: • Effects in the eye: Infection or inflammation of the eye; dryness of the eye or small breaks in the film of liquid on the surface of the eye; eye discharge; itchy eyelids; clouding of the eye and vision may decrease somewhat; eye pain; feeling of grittiness or having something in the eye; general eye redness shortly after drops are put in; spots or patches of eye redness; eye inflammation caused by an allergic reaction or prominent blood vessels; eyes can become watery, sensitive to light; swelling around the eye; blurred vision
Maltese: Infezzjoni jew infjammazzjoni tal-għajn; nixfa tal-għajn jew qsim żgħir fil-kisja tal-likwidu fuq il-wiċċ tal-għajn; tnixxija mill-għajn; ħakk fil-kappell tal-għajn; għajn imċajpra u l-vista tista' tonqos; uġigħ fl-għajnejn; tħoss bħal żrar jew li għandek xi ħaġa fl-għajn; ħmura ġenerali tal-għajn ftit wara li tqattar; tikek jew irqajja' ta' ħmura tal-għajnejn; infjammazzjoni tal-għajnejn ikkawżata minn reazzjoni allerġika jew vażi prominenti; l-għajnejn jistgħu jdemmgħu, sensittiv għad-dawl; nefħa madwar l-għajn; vista mċajpra
English: County Kerry Ireland
Maltese: County Kerry L-Irlanda
English: System Organ Class
Maltese: Klassi tasSistema talOrgani
English: Date of first authorisation: 28 February 2002 Date of latest renewal: 20 November 2006
Maltese: Data tal-ewwel awtorizzazzjoni: 28 ta' Frar 2002 Data tal-aħħar tiġdid: 20 ta' Novembru 2006
English: LEO Pharma A/S Industriparken 55 2750 Ballerup Denmark
Maltese: LEO Pharma A/S Industriparken 55 2750
English: Butylhydroxytoluene (E321) 15 micrograms/g ointment.
Maltese: Butylhydroxytoluene (E321) 15 mikrogramma/g ingwent.
English: • The active substance is tacrolimus monohydrate.
Maltese: • Is-sustanza attiva hi tacrolimus monohydrate.
English: Protopic contains butylhydroxytoluene (E321)
Maltese: Protopic fih butylhydroxytoluene (E321)
English: Table 4: Efficacy (moderate to severe subpopulation)
Maltese: Tabella 4: Effikaċja (subpopolazzjoni moderata għal severa)
English: Rosacea* Lentigo*
Maltese: Lentigo*
English: Busuttil Ltd Tel: +356 2144 7184
Maltese: E.J. Busuttil Ltd Tel: +356 2144 7184
English: Treatment with Protopic may be associated with an increased risk of folliculitis and herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption) (see section 4.8).
Maltese: Waqt it-trattament bi Protopic jista' jkun hemm żieda fir-riskju ta' follikulite u infezzjoni bil-herpes (dermatite sempliċi tal-herpes [eczema herpeticum], herpes simplex [ħżiża], eruzzjoni variċelliforma ta' Kaposi) (ara sezzjoni 4.8).
English: Adults, ≥16 years
Maltese: Adulti, ≥ 16-il sena
English: Acne*
Maltese: Akne*
English: Systemically available tacrolimus is metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4).
Maltese: Tacrolimus fid-demm jiġi metabolizzat permezz taċ-Ċitokromju tal-fwied P450 3A4 (CYP3A4).
English: Fertility There are no fertility data available.
Maltese: Fertilità M'hemmx informazzjoni disponibbli dwar il-fertilità.
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 innutati bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10) u mhux komuni (≥ 1/1,000 sa < 1/100).
English: Analysis of the response rate at week 5 showed equivalence between the treatment groups (hydrocortisone 98.3%, tacrolimus ointment 95.4%; 7-11 years: 100% in both arms).
Maltese: Analiżi tar rata tar-rispons f'ġimgħa 5 wriet ekwivalenza bejn il-gruppi ta' kura (hydrocortisone 98.3%, ingwent tacrolimus 95.4%; 7-11-il sena: 100% fiż-żewġ partijiet tal-istudju).
English: Other medicines, cosmetics and Protopic
Maltese: Mediċini oħra, kosmetiċi u Protopic
English: Protopic with alcohol
Maltese: Protopic mal-alkoħol
English: Tel: +48 22 244 18 40
Maltese: Sp. z o.o. Tel: +48 22 244 18 40
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: Herpes simplex, Herpes virus infection, Kaposi's varicelliform eruption*
Maltese: Herpes simplex, Infezzjoni bil-virus talherpes, eruzzjoni varicelliform ta' Kaposi*
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 klinika.
English: Astellas Ireland Co. Ltd. Killorglin
Maltese: Astellas Ireland Co Ltd.
English: It may harm them,
Maltese: Follikulite,
English: Eczema herpeticum, Folliculitis,
Maltese: Ekżema herpeticum,
English: 4.6 Fertility, Pregnancy and lactation
Maltese: .6 Fertilità, tqala u treddigħ
English: Children, 2-15 years
Maltese: Tfal, 2-15-il sena
English: • The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321) and all-rac-α-tocopherol.
Maltese: • Is-sustanzi mhux attivi l-oħra huma white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321) u all-rac-α-tocopherol.
English: The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent.
Maltese: Is-sustanza attiva ta' Protopic, tacrolimus monohydrate, huwa aġent immuno-modulatorju.
English: Hydrocortisone acetate 1% Twice daily (N=207)
Maltese: Hydrocortisone acetate 1% Darbtejn kuljum (N=207)
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 ċelluli T 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: 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 siegħa fil-kbar u 65 siegħa fit-tfal.
English: OTHER
Maltese: DE
English: Adults and adolescents (16 years of age and above)
Maltese: Adulti u adolexxenti (minn 16-il sena 'l fuq)
English: In a study of maintenance treatment (twice weekly treatment) in adults and children with moderate and severe atopic dermatitis the following adverse events were noted to occur more frequently than in the control group: application site impetigo (7.7% in children) and application site infections (6.4% in children and 6.3% in adults).
Maltese: kontroll: impetigo fis-sit tal-applikazzjoni (7.7% fit-tfal) u infezzjonijiet fis-sit tal-applikazzjoni (6.4% fi tfal u 6.3% fl-adulti).
English: Protopic 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years.
Maltese: Protopic 0.03% ingwent hu indikat f'persuni adulti, fl-adolexxenti u fit-tfal mill-età ta' sentejn.
English: 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: mill-anqas 60% skont l-mEASI (modified Eczema Area and Severity Index) bejn il-bidu talesperiment u kif skadew 3 xhur.
English: Adults (16 years of age and older)
Maltese: Adulti (minn 16-il sena 'l fuq)
English: Ointment 30 g
Maltese: Ingwent 30 g 60 g
English: • If you have infected lesions.
Maltese: • Jekk għandek leżjonijiet infettati.
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 jiġix metabolizzat fil-ġilda umana, u għalhekk m'hemmx periklu ta' interazzjoni fillivell tal-ġilda li jista' jaffettwa l-metaboliżmu ta' tacrolimus.
English: The potential for local immunosuppression (possibly resulting in infections or cutaneous malignancies) in the long term (i.e. over a period of years) is unknown (see section 5.1).
Maltese: Il-potenzjal għal immunosuppressjoni lokali (possibbilment jirriżulta f'infezzjonijiet jew tumuri malinni fil-ġilda) fit-tul (jiġifieri fuq perjodu ta' snin) mhux magħruf (ara sezzjoni 5.1).
English: improvement in mEASI (Primary Endpoint)§§
Maltese: (Punt aħħari Primarju)§
English: Protopic contains the active substance tacrolimus, a calcineurin inhibitor.
Maltese: Protopic fih is-sustanza attiva tacrolimus, inibitur kalċinewriniku.
English: • If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6) or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).
Maltese: • jekk inti allerġiku għal tacrolimus jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fissezzjoni 6) jew tal-antibijotiċi macrolide (eż. azithromycin, clarithromycin, erythromycin).
English: Improvement ≥ 90% in Physician's Global Evaluation
Maltese: Titjib ≥ 90% f'Evalwazzjoni Globali tat-Tabib
English: Mean (SD) percentage of days of DE exacerbation treatment DE: disease exacerbation P<0.001 in favour of tacrolimus ointment 0.1% (adults) and 0.03% (children) for the primary and key secondary endpoints
Maltese: P<0.001 favur ingwent tacrolimus 0.1% (adulti) u 0.03% (tfal) għall-punti ta' tmiem primarji u sekondarji ewlenin
English: Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation)
Maltese: Parestesiji u disestesiji (iperestesija, sensazzjoni ta' ħruq)
English: Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
Maltese: Studji sistemiċi kanċeroġeniċi fuq ġrieden (18-il xahar) u firien (24 xahar) urew li tacrolimus m'għandux potenzjal kanċeroġenu.
English: Pharmacotherapeutic group: Other dermatologicals, ATC code: D11AH01
Maltese: Prodotti mediċinali tal-ġilda, Kodiċi ATC:
English: • feeling of warmth
Maltese: • sensazzjoni ta' sħana
English: Vehicle Twice weekly (N=75)
Maltese: (N=75)
English: The pharmacokinetics of tacrolimus after topical application are similar to those reported in adults, with minimal systemic exposure and no evidence of accumulation (see above).
Maltese: Il-farmakokinetika ta' tacrolimus wara applikazzjoni topika hi simili għal dik irrappurtata f'persuni adulti, b'espożizzjoni sistemika minima u l-ebda evidenza ta' akkumulazzjoni (ara hawn fuq).
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: 1 g ointment contains: 1.0 mg tacrolimus (as monohydrate)
Maltese: 1 g ingwent fih: 1.0 mg tacrolimus (bħala monohydrate)
English: • redness
Maltese: • uġigħ
English: Formal topical drug interaction studies with tacrolimus ointment have not been conducted.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni L-interazzjoni topika ta' tacrolimus ingwent għadha ma ġietx studjata formalment.
English: Contents of the pack and other information What Protopic contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Protopic
English: Systemically available tacrolimus is extensively metabolised in the liver via CYP3A4.
Maltese: Fid-demm, tacrolimus jiġi metabolizzat bil-qawwa fil-fwied permezz ta' CYP3A4.
English: 1 g ointment contains: 0.3 mg tacrolimus (as monohydrate)
Maltese: 1 g ingwent fih: 0.3 mg tacrolimus (bħala monohydrate)
English: Response rate of ≥ 60%
Maltese: Rata ta' rispons ta' ≥ 90% fl
English: Protopic ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Maltese: Is-sigurtà u l-effikaċja ta' Protopic ingwent għadhom ma ġewx eżaminati fit-trattament tad-dermatite atopika klinikament infettata.
English: In the second trial, children aged from 2 to 15 years with moderate to severe atopic dermatitis received twice daily treatment for three weeks of 0.03% tacrolimus ointment, 0.1% tacrolimus ointment or 1% hydrocortisone acetate ointment.
Maltese: Fit-tieni prova, tfal bejn 2 sa 15-il sena, li kienu jsofru minn dermatite atopika, moderata għal qalila, ġew mogħtija 0.03% tacrolimus ingwent, 0.1% tacrolimus ingwent u ingwent ta' 1% hydrocortisone acetate darbtejn kuljum għal żmien ta' 3 ġimgħat.
English: No effect on immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity has been observed (see section 5.1).
Maltese: Ma kien osservat l-ebda effett fuq ir rispons immedjat għat-tilqima, il-ġenerazzjoni ta' memorja immuni, jew immunità umorali u medjata miċ-ċelluli (ara sezzjoni 5.1).
English: • local skin infection regardless of specific cause including but not limited to: inflamed or infected hair follicles, cold sores, generalised herpes simplex infections
Maltese: • infezzjoni lokali tal-ġilda irrispettivament mill-kawża speċifika li tinkludi iżda mhux limitata għal: follikuli tax-xagħar infjammati jew infettati, infezzjonijiet b'herpes virali (eż. ponot minħabba d-deni, infezzjonijiet ġeneralizzati b'herpes simplex)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPIC 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
Maltese: PROTOPIC 0.03% INGWENT (10 g, 30 g, 60 g KARTUNA)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPIC 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
Maltese: PROTOPIC 0.1% INGWENT (10 g, 30 g, 60 g KARTUNA)
English: Median mEASI as Percentage of Baseline mean AUC (Primary Endpoint)§
Maltese: Il-medjan tal-mEASI bħala Persentaġġ tal-medja tal-Valur bażi AUC (Punt aħħari Primarju)§
English: Hypersensitivity to the active substance, macrolides in general, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, macrolides b'mod ġenerali, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: one in adult patients (≥16 years) and one in paediatric patients (2-15 years).
Maltese: III ta' disinn simili, wieħed fuq pazjenti adulti (≥ 16-il sena) u wieħed f'pazjenti pedjatriċi (2-15-il sena).
English: Lymphadenopathy was uncommonly (0.8%) reported in clinical trials.
Maltese: Każijiet mhux komuni (0.8%) ta' limfadenopatija kienu rrapurtati fi provi kliniċi.
English: 1 g of Protopic 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
Maltese: 1 g ta' Protopic 0.03% ingwent fih 0.3 mg ta' tacrolimus bħala tacrolimus monohydrate (0.03%).
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 jistax jeskludi l possibbiltà 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.