FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardboard box with 1 colourless type I glass injection vial of 100 ml, which is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
Maltese: Kaxxa tal-kartun b'kunjett għal injezzjoni wieħed, tal-ħġieġ trasparenti , tat-tip I ta' 100 ml, li huwa magħluq bil-lastku bromobutil u ssiġillat b'għatu tal-aluminju.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Maltese: 6.6 Prekawzjonijiet speċjali għar-rimi tal-prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar-rimi li huwa derivat minn dawn il-prodotti
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) each ml contains:
Maltese: Sustanza(i) mhux attiva(i):
English: Package size
Maltese: Daqs tal-pakkett flixkun (HDPE) 175 pillolla
English: Packaging
Maltese: Il-pakkett li jmiss malprodott
English: Gel 60 g
Maltese: Ġell 60 g
English: Comparator N=95
Maltese: Komparatur N=95
English: Date of first authorisation: 3 March 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 3 ta' Marzu 2017
English: • The active substance is chlormethine.
Maltese: • Is-sustanza attiva hi chlormethine.
English: Qualifying prior therapies included topical corticosteroids, phototherapy, topical bexarotene, and topical nitrogen mustard.
Maltese: Terapiji preċedenti li kkwalifikaw inkludew kortikosterojdi topiċi, fototerapija, bexarotene topiku, u nitrogen mustard topiku.
English: A small number of subjects (6.3%, 8/128) treated with Ledaga utilised topical corticosteroids.
Maltese: Numru żgħir ta' individwi (6.3 %, 8/128) ittrattati b'Ledaga użaw kortikosterojdi topiċi.
English: Response rates (%)
Maltese: Rati ta' rispons (%)
English: CAILS Overall Response (CR+PR)
Maltese: Rispons Ġenerali ta' CAILS (CR+PR)
English: In a randomised-controlled trial (n=128 exposed to Ledaga for a median duration of 52 weeks), the most frequent adverse reactions to Ledaga were skin related: dermatitis (54.7%; e.g., skin irritation, erythema, rash, urticaria, skin-burning sensation, pain of the skin), pruritus (20.3%), skin infections (11.7%), skin ulceration and blistering (6.3%), and skin hyperpigmentation (5.5%).
Maltese: Fi prova randomised ikkontrollata (n=128 esposti għal Ledaga għal tul medjan ta' 52 ġimgħa), irreazzjonijiet avversi l-aktar frekwenti għal Ledaga kienu relatati mal-ġilda: dermatite (54.7 %; eż., irritazzjoni tal-ġilda, eritema, raxx, urtikarja, sensazzjoni ta' ħruq fil-ġilda, uġigħ fil-ġilda), ħakk (20.3 %), infezzjonijiet tal-ġilda (11.7 %), ulċerazzjoni u nfafet tal-ġilda (6.3 %), u pigmentazzjoni eċċessiva tal-ġilda (5.5 %).
English: EXP Discard 60 days after defrosting: ../../....
Maltese: EXP Armi 60 ġurnata wara l-iddefrostjar: ../../....
English: For storage conditions after defrosting Ledaga, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-iddefrostjar ta' Ledaga, ara sezzjoni 6.3.
English: After defrosting 60 days in the refrigerator (+2 °C to +8 °C).
Maltese: 60 ġurnata fil-friġġ (+2 °C sa +8 °C).
English: Hydroxypropylcellulose
Maltese: Hydroxypropylcellulose Sodium chloride
English: In the EE population, the percentage of patients who achieved a confirmed response by CAILS was similar between disease stages IA (79.6 %) and IB-IIA (73.2%).
Maltese: Fil-popolazzjoni EE, il-perċentwali ta' pazjenti li kisbu rispons ikkonfermat minn CAILS kien simili bejn l-istadji tal-marda IA (79.6 %) u IB-IIA (73.2 %).
English: The ratio of response and the 95% confidence interval in the ITT population were 1.226 (0.974-1.552) for CAILS and 1.017 (0.783-1.321) for SWAT and therefore consistent with those in the EE population for both the overall CAILS and SWAT responses.
Maltese: (0.974-1.552) għal CAILS u ta' 1.017 (0.783-1.321) għal SWAT u għalhekk konsistenti ma' dawk fil-popolazzjoni EE għar-risponsi ġenerali kemm ta' CAILS kif ukoll ta' SWAT.
English: • The other ingredients are: diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerol, lactic acid, hydroxypropylcellulose, sodium chloride, menthol racemic, disodium edetate, and butylhydroxytoluene.
Maltese: • Is-sustanza l-oħra huma: diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerol, lactic acid, hydroxypropylcellulose, sodium chloride, menthol racemic, disodium edetate, u butylhydroxytoluene.
English: In the controlled clinical trial, 31% (79/255) of the study population were aged 65 years or older.
Maltese: Fil-prova klinika kkontrollata, 31 % (79/255) tal-popolazzjoni tal-istudju kellhom 65 sena jew aktar.
English: Dermatitis, skin infections, pruritus
Maltese: Dermatite, infezzjonijiet tal-ġilda, ħakk
English: Hypersensitivity reactions, including isolated cases of anaphylaxis, have been reported in the literature after the use of topical formulations of chlormethine (see sections 4.3 and 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva, inklużi każijiet iżolati ta' anafilassi, ġew irrappurtati filletteratura wara l-użu ta' formulazzjonijiet topiċi ta' chlormethine (ara sezzjonijiet 4.3 u 4.8).
English: Frequencies were defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi ġew iddefiniti bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa
English: Store and transport frozen (−15 °C to −25 °C).
Maltese: 3 snin fil-friża (-15 °C sa -25 °C).
English: CAILS = Composite Assessment of Index Lesion Severity; CI = confidence interval; CR = Complete Response; PR = Partial Response; SWAT = Severity Weighted Assessment Tool.
Maltese: CAILS = Valutazzjoni Komposta tas-Severità tal-Ġerħa Maġġuri (Composite Assessment of Index Lesion Severity); CI = intervall ta' kunfidenza (confidence interval); CR = Rispons
English: Each tube contains 10.5 grams of propylene glycol and 6 micrograms of butylhydroxytoluene.
Maltese: 5 grammi ta' propylene glycol u 6 mikrogrammi ta' butylhydroxytoluene.
English: Table 1 CAILS and SWAT-confirmed response rates by 12 months in Study 201 (efficacy evaluable population)
Maltese: Tabella 1 Rati ta' rispons ikkonfermati minn CAILS u SWAT sa 12-il xahar fi Studju 201
English: The efficacy and safety of Ledaga were assessed in a randomised, multicentre, observer-blinded, active-controlled, non-inferiority clinical trial (Study 201) of 260 adult patients with Stage IA (141), IB (115), and IIA (4) MF-type CTCL who had received at least one prior skin-directed therapy.
Maltese: Effikaċja klinika u sigurtà L-effikaċja u s-sigurtà ta' Ledaga ġew ivvalutati fi prova klinika mhux ta' inferjorità, ikkontrollata b'sustanza attiva, b'osservatur mgħammad, multiċentrika u randomised (Studju 201) ta' 260 pazjent adult b'MF-type CTCL fi Stadju IA (141), IB (115), u IIA (4) li kienu rċevew mill-anqas terapija preċedenti waħda diretta lejn il-ġilda.
English: Pharmacotherapeutic group: Antineoplastic agents, nitrogen mustard analogues, ATC code: L01AA05.
Maltese: Sustanzi antineoplastiċi, analogi ta' nitrogen mustard, Kodiċi ATC:
English: Patients were not required to be refractory to or intolerant of prior therapies.
Maltese: Il-pazjenti ma kinux meħtieġa li jkunu refrattarji jew intolleranti għal terapiji preċedenti.
English: A partial response was defined as an at least 50% reduction in the baseline CAILS score.
Maltese: Rispons parzjali kien iddefinit bħala tnaqqis ta' mill-anqas 50 % fil-punteġġ bażi ta' CAILS.
English: Topical use.
Maltese: Mhux applikabbli.
English: Ledaga contains propylene glycol and butylhydroxytoluene
Maltese: Ledaga fih propylene glycol u butylhydroxytoluene
English: Chlormethine caused foetal malformations in mice and rats when given as single injections of 1-2.5 mg/kg.
Maltese: Chlormethine kkawża malformazzjoni fil-feti fi ġrieden u firien meta ngħata bħala injezzjonijiet singoli ta' 1-2.5 mg/kg.
English: See end of section 2 for further information on propylene glycol and butylhydroxytoluene.
Maltese: Ara tmiem is-sezzjoni 2 għal aktar informazzjoni dwar propylene glycol u butylhydroxytoluene.
English: EXP Discard 60 days after defrosting
Maltese: EXP Armi 60 ġurnata wara l-iddefrostjar
English: Ledaga 160 micrograms/g gel
Maltese: Ledaga ġell ta' 160 mikrogramma/g
English: Each gram of gel contains chlormethine hydrochloride equivalent to 160 micrograms of chlormethine.
Maltese: Kull gramma ta' ġell fiha chlormethine hydrochloride ekwivalenti għal 160 mikrogramma ta' chlormethine.
English: Ledaga 160 micrograms/g gel chlormethine
Maltese: Ledaga ġell ta' 160 mikrogramma/g chlormethine
English: Gel.
Maltese: Proporzjon
English: Recommended application instructions should be followed to prevent secondary exposure (see section 4.2).
Maltese: Għandhom jiġu segwiti l-istruzzjonijiet dwar l-applikazzjoni rakkomandata biex jiġi evitat esponiment sekondarju (ara sezzjoni 4.2).
English: Cutaneous hypersensitivity reactions were reported in 2.3% of the treated patients.
Maltese: Ġew irrappurtati reazzjonijiet ta' sensittività eċċessiva fil-ġilda fi 2.3 %
English: Secondary exposure to Ledaga
Maltese: Esponiment sekondarju għal Ledaga
English: Patients were stratified based on stage (IA vs IB and IIA) and then randomised to receive either Ledaga (equivalent to 0.02% chlormethine HCl) or the comparator (a petroleum-based 0.02% chlormethine HCl ointment).
Maltese: Il-pazjenti ġew stratifikati abbażi tal-istadju (IA vs IB u IIA) u mbagħad randomised biex jirċievu jew Ledaga (ekwivalenti għal 0.02 % ta'
English: Intravenously administered chlormethine impaired male fertility in rats at a daily dose of ≥ 0.25 mg/kg for 2 weeks.
Maltese: Chlormethine mogħti ġol-vina indebolixxa l-fertilità maskili fil-firien b'doża ta' kuljum ta' ≥ 0.25 mg/kg għal ġimagħtejn.
English: Τηλ : +33 1 47 73 64 58 Γαλλία
Maltese: Τηλ : +33 1 47 73 64 58
English: Panel 3
Maltese: ANNESS III
English: The safety profile observed in elderly patients was consistent with that in the overall patient population.
Maltese: Il-profil tas-sigurtà osservat f'pazjenti anzjani kien konsistenti ma' dak fil-popolazzjoni ġenerali talpazjenti.
English: • Ledaga should be supplied with a transparent, sealable, child-resistant plastic bag to prevent secondary exposure and contamination when Ledaga is stored in the refrigerator:
Maltese: • Ledaga għandu jiġi pprovdut b'borża tal-plastik trasparenti, siġillabbli u reżistenti għat-tfal biex jiġu evitati esponiment u kontaminazzjoni sekondarji meta Ledaga jkun maħżun fil-friġġ:
English: The recommended application instructions should be followed (see section 4.2).
Maltese: Għandhom jiġu segwiti l istruzzjonijiet dwar l-applikazzjoni rakkomandata (ara sezzjoni 4.2).
English: Recordati Rare Diseases UK Ltd. Tel: +44 (0)1491 414333
Maltese: Tel: +44 (0)1491 414333
English: - Apply Ledaga immediately or within 30 minutes of removing it from the refrigerator.
Maltese: - Applika Ledaga immedjatament jew fi żmien 30 minuta wara li tneħħih mill-friġġ.
English: Skin ulceration and blistering, skin hyperpigmentation
Maltese: Ulċerazzjoni u nfafet tal-ġilda, pigmentazzjoni eċċessiva tal-ġilda
English: The safety and efficacy of Ledaga in children aged 0 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Ledaga fit-tfal minn età ta' 0 sa 18-il sena għadhom ma ġewx determinati s'issa.
English: Recordati AB. Tel : +46 8 545 80 230
Maltese: Tel : +46 8 545 80 230
English: Assessment was undertaken by a blinded observer.
Maltese: Il-valutazzjoni twettqet minn osservatur mgħammad.
English: There were no reports of systemic tumours after topical administration of chlormethine.
Maltese: Ma kien hemm l-ebda rapport ta' tumuri sistemiċi wara għoti topiku ta' chlormethine.
English: There is limited experience of chlormethine in pregnant women.
Maltese: Hemm esperjenza limitata ta' chlormethine f'nisa tqal.
English: - Skin cancers (abnormal growth of the cells in the skin) have been reported after application of chlormethine to the skin, although it is not known whether chlormethine causes this.
Maltese: - Kanċers tal-ġilda (tkabbir anormali taċ-ċelluli fil-ġilda) ġew irrappurtati wara applikazzjoni ta' chlormethine fuq il-ġilda, minkejja li mhux magħruf jekk chlormethine jikkawżax dan.
English: Sodium chloride Menthol racemic Disodium edetate Butylhydroxytoluene
Maltese: Disodium edetate Butylhydroxytoluene
English: In order to minimise and prevent the Important Identified Risk of “Toxicity to mucous membranes / eye” and the Important Potential Risk of “Secondary exposure to someone other than the patient”, the MAH shall ensure that, the following additional risk minimisation measures are fulfilled in each Member State (MS) where Ledaga is marketed:
Maltese: Sabiex jiġi mminimizzat u evitat ir-Riskju Identifikat Importanti ta' “Tossiċità għall-membrani mukużi / l-għajnejn” u r-Riskju Potenzjali Importanti ta' “Esponiment sekondarju għal persuna li mhijiex il-pazjent”, l-MAH għandu jiżgura li, il-miżuri addizzjonali għall-minimizzazzjoni tar-riskji li ġejjin ikunu ssodisfati f'kull Stat Membru fejn Ledaga jitqiegħed fis-suq:
English: Reductions in mean CAILS scores were observed as early as at 4 weeks, with further reductions observed with continuing therapy.
Maltese: Ġie osservat tnaqqis fil-punteġġi medji ta' CAILS sa minn 4 ġimgħat bi tnaqqis ulterjuri osservat b'terapija kontinwa.
English: Package leaflet: Information for the patient Ledaga 160 micrograms/g gel chlormethine
Maltese: Informazzjoni għall-pazjent Ledaga ġell ta' 160 mikrogramma/g chlormethine
English: Patients should be assessed during treatment for skin reactions such as dermatitis (e.g., redness, swelling, inflammation), pruritus, blisters, ulceration, and skin infections.
Maltese: Il-pazjenti għandhom jiġu vvalutati waqt trattament għal reazzjonijiet tal-ġilda bħal dermatite (eż., ħmura, nefħa, infjammazzjoni), ħakk, infafet, ulċerazzjoni, u infezzjonijiet tal-ġilda.
English: Other medicines and Ledaga
Maltese: Mediċini oħra u Ledaga
English: Efficacy was evaluated in the Efficacy Evaluable (EE) population, which included all 185 patients who were treated for at least 6 months with no major protocol deviations [Table 1], and in the IntentTo-Treat (ITT) population, which included all 260 randomised patients.
Maltese: Evaluable), li inkludiet il-185 pazjenti kollha li kienu ttrattati għal mill-anqas 6 xhur mingħajr l-ebda devjazzjoni kbira mill-protokoll [Tabella 1], u fil-popolazzjoni Maħsuba għat-Trattament (ITTIntent-To-Treat), li inkludiet il-260 pazjent randomised kollha.
English: Teл.
Maltese: Ltd.
English: • irrigation should be performed immediately for at least 15 minutes with copious amounts of water (or sodium chloride 9 mg/ml (0.9%) solution for injection, or a balanced salt ophthalmic irrigating solution may be used if there is eye exposure), and
Maltese: • għandha tinħasel immedjatament għal mill-anqas 15-il minuta b'ammont abbundanti ta' ilma (jew soluzzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride għal injezzjoni, jew tista' tintuża soluzzjoni bbilanċjata ta' melħ għall-ħasil tal-għajnejn jekk ikun hemm esponiment tal-għajnejn), u • għandha tinkiseb kura medika immedjatament (inkluża konsultazzjoni oftalmoloġika jekk ikun hemm esponiment tal-għajnejn).
English: Unopened tube 3 years in the freezer (-15 °C to -25 °C).
Maltese: Żomm iffriżat waqt il-ħażna u l-ġarr (−15°C sa −25°C).
English: Chlormethine was shown to be genotoxic in bacterial, plant, and mammalian cells.
Maltese: Chlormethine ntwera li huwa ġenotossiku f'ċelluli tal-batterja, tal-pjanti, u tal-mammiferi.
English: Each gram of gel contains 160 micrograms of chlormethine.
Maltese: Kull gramma ta' ġell fiha 160 mikrogramma ta' chlormethine.
English: Dermal application of chlormethine to mice at a dose of 15 mg/kg for up to 33 weeks resulted in skin tumours (squamous cell carcinomas and skin papilloma).
Maltese: Applikazzjoni fuq il-ġilda ta' chlormethine lill-ġrieden b'doża ta' 15 mg/kg għal perjodu sa 33 ġimgħa rriżultat f'tumuri fil-ġilda (karċinoma taċ-ċellula skwamuża u papilloma tal-ġilda).
English: Chlormethine is a bifunctional alkylating agent that inhibits rapidly proliferating cells.
Maltese: Chlormethine huwa sustanza alkilanti b'żewġ funzjonijiet li tinibixxi ċelluli li jirriproduċu b'mod rapidu.
English: A complete response was defined as a confirmed CAILS score of 0.
Maltese: Rispons sħiħ kien iddefinit bħala punteġġ ikkonfermat ta' CAILS ta' 0.
English: Upon improvement, treatment with Ledaga can be restarted at a reduced frequency of once every 3 days.
Maltese: Wara titjib, ittrattament b'Ledaga jista' jerġa' jinbeda bi frekwenza mnaqqsa ta' darba kull 3 ijiem.
English: The median daily usage of Ledaga was 1.8 g. The maximum individual daily usage in the trial was 10.5 g of gel (i.e., 2.1 mg of chlormethine HCl).
Maltese: g ta' ġell (jiġifieri, 2.1 mg ta' chlormethine HC1).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of European Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni Ewropea (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: • Ledaga should be applied to completely dry skin at least 4 hours before or 30 minutes after showering or washing.
Maltese: • Ledaga għandu jiġi applikat fuq ġilda kompletament niexfa mill-anqas 4 sigħat qabel jew 30 minuta wara li l-pazjent jieħu doċċa jew jinħasel.
English: Ledaga contains the active substance chlormethine.
Maltese: X'inhu Ledaga u għalxiex jintuża Ledaga fih is-sustanza attiva chlormethine.
English: How to store Ledaga
Maltese: X'fih Ledaga
English: The primary efficacy endpoint in Study 201 was the Composite Assessment of Index Lesion Severity (CAILS) response rate.
Maltese: Il-punt tat-tmiem primarju tal-effikaċja fi Studju 201 kien ir-rata ta' rispons tal-Valutazzjoni Komposta tas-Severità tal-Ġerħa Maġġuri (CAILS - Composite Assessment of Index Lesion Severity).
English: The medicinal product contains propylene glycol and butylhydroxytoluene, which may cause skin irritation (e.g., contact dermatitis).
Maltese: Eċċipjenti Il-prodott mediċinali fih propylene glycol u butylhydroxytoluene, li jistgħu jikkawżaw irritazzjoni tal ġilda (eż., dermatite tal-kuntatt).
English: MF-type CTCL is a condition in which certain cells of the body's immune system called Tlymphocytes become cancerous and affect the skin.
Maltese: MF-type CTCL hija kondizzjoni li fiha ċerti ċelluli tas-sistema immuni tal-ġisem imsejħa limfoċiti T
English: Hypersensitivity to chlormethine or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal chlormethine jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1.
English: A response was defined as an at least 50% improvement in the baseline CAILS score, confirmed at a subsequent visit at least 4 weeks later.
Maltese: Rispons kien iddefinit bħala titjib ta' mill-anqas 50 % fil-punteġġ bażi ta' CAILS, ikkonfermat fi żjara sussegwenti mill-anqas 4 ġimgħat wara.
English: - Tell your doctor if you have ever had an allergic reaction to chlormethine.
Maltese: - Għid lit-tabib tiegħek jekk qattx kellek reazzjoni allerġika għal chlormethine.
English: This is an anti-cancer medicine used on the skin to treat mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL).
Maltese: Dan huwa mediċina kontra l-kanċer użat fuq il-ġilda għat trattament ta' limfoma taċ-ċellula T fil-ġilda tat-tip mikosi fungojdi (MF-type CTCL - mycosis fungoides-type cutaneous T-cell lymphoma)
English: Store and transport frozen (−15 °C to −25 °C) After defrosting, store in a refrigerator (+2 °C to +8 °C) Keep Ledaga in its box and inside the child-resistant plastic bag
Maltese: Wara l-iddefrostjar, aħżen fi friġġ (+2 °C sa +8 °C) Żomm Ledaga fil-kaxxa tiegħu u ġewwa l-borża tal-plastik reżistenti għat-tfal
English: • Fire, flame, and smoking must be avoided until Ledaga has dried.
Maltese: • Nar, fjamma, u tipjip iridu jiġu evitati sakemm jinxef Ledaga.
English: Cytotoxic Flammable
Maltese: Menthol racemic
English: • A patient alert card, sized to be included in Ledaga outer packaging, together with the Patient Information Leaflet (PIL) is provided to all patients and caregivers who are expected to administer and use Ledaga.
Maltese: • Kard ta' twissija għall-pazjent, f'daqs biex tiġi inkluża fil-pakkett ta' barra ta' Ledaga,
English: Do not give this medicine to children and adolescents under the age of 18 years because the safety and effectiveness have not been established for this age group.
Maltese: Tagħtix din il-mediċina lil tfal u adolexxenti taħt l-età ta' 18-il sena minħabba li s-sigurtà u l-effettività ma ġewx stabbiliti għal dan il-grupp ta' età.
English: Propylene glycol and butylhydroxytoluene may also cause skin irritation.
Maltese: Propylene glycol u butylhydroxytoluene jistgħu jikkawżaw ukoll irritazzjoni tal-ġilda.
English: Ledaga is a clear, colourless gel.
Maltese: Ledaga huwa ġell ċar, mingħajr kulur.
English: Direct skin contact with Ledaga should be avoided in individuals other than the patient.
Maltese: Kuntatt dirett tal-ġilda ma' Ledaga għandu jiġi evitat f'individwi li mhumiex il-pazjent.
English: Clear, colourless gel.
Maltese: Wara l-iddefrostjar
English: The face, genitalia, anus, and intertriginous skin are at increased risk of skin reactions to topical chlormethine.
Maltese: Il-wiċċ, ilġenitali, l-anus, u l-ġilda intertriġinuża jinsabu f'riskju miżjud ta' reazzjonijiet tal-ġilda għal chlormethine topiku.
English: Exposure of the eyes to chlormethine causes pain, burns, inflammation, photophobia, and blurred vision.
Maltese: Esponiment tal-għajnejn għal chlormethine jikkawża uġigħ, ħruq, infjammazzjoni, fotofobija, u vista mċajpra.
English: For dose modification information in case of skin reactions, see section 4.2.
Maltese: Għal informazzjoni dwar il-modifika tad-doża fil-każ ta' reazzjonijiet tal-ġilda, ara sezzjoni 4.2.
English: Similarly, patients who received chlormethine gel 0.04% in a follow-up study (Study 202) had no measurable concentrations of chlormethine or its degradation product (half-mustard) in blood collected 1 hour post-application on Day 1 or after 2, 4, or 6 months of treatment.
Maltese: Bl-istess mod, pazjenti li rċevew ġell ta' chlormethine ta' 0.04 % fi studju ta' segwitu (Studju 202) ma kellhom l-ebda konċentrazzjoni li tista' titkejjel ta' chlormethine jew tal-prodott ta' degradazzjoni tiegħu (half-mustard) fid-demm miġbur siegħa wara l-applikazzjoni fl-ewwel Ġurnata jew wara 2, 4
English: - Contact with your eyes must be avoided.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni.
English: Non-inferiority was considered to have been demonstrated if the lower bound of the 95% confidence interval around the ratio of response rates (Ledaga/comparator) was greater than or equal to 0.75.
Maltese: rispons (Ledaga/komparatur) kien akbar minn jew ekwivalenti għal 0.75.
English: If Ledaga gets in your eyes, rinse your eyes right away for at least 15 minutes with large amounts of water, a solution known as “0.9% sodium chloride solution” or an eye-wash solution, and seek medical assistance (including an eye doctor) as soon as possible.
Maltese: Jekk Ledaga jidħol f'għajnejk, laħlaħ għajnejk mill-ewwel għal mill-anqas 15-il minuta b'ammonti kbar ta' ilma, soluzzjoni magħrufa bħala “soluzzjoni ta' 0.9 % sodium chloride” jew soluzzjoni tal-ħasil tal-għajnejn, u fittex assistenza medika (inkluż tabib talgħajnejn) malajr kemm jista' jkun.
English: The dosing recommendation for elderly patients ( ≥ 65 years old) is the same as for younger adult patients (see section 4.8).
Maltese: Id-doża rakkomandata għal pazjenti anzjani (≥ 65 sena) hija l-istess bħal dik għall-pazjenti adulti iżgħar (ara sezzjoni 4.8).