FrancophonIA/ELRC3.0 huggingface dataset:
English: Meprobamate may induce generalized tonic-clonic attacks in the predisposed which may be a drawback during alcohol withdrawal, a condition characterized by an increased susceptibility to convulsions.
Maltese: Meprobamat jista' jikkaġuna attakki toniċi-kloniċi ġeneralizzati f'dawk predisposti li jista' jkun ta' żvantaġġ waqt l-astinenza mill-alkoħol, kundizzjoni karatterizzata minn suxxettibilità akbar għal konvulżjonijiet.
English: Noting that meprobamate has a relatively narrow therapeutic index, with a steep dose-response curve, the CHMP therefore concluded that accidental overdoses are a serious risk with meprobamate.
Maltese: Is-CHMP irreveda l-proposti talMAH iżda kkunsidra li ma kinux biżżejjed biex inaqqsu r-riskju identifikat ta' meprobamat.
English: In summary, the CHMP assessed the totality of the available data, including responses submitted by the MAHs in writing and during an oral explanation, as well as the nationally-conducted French pharmacovigilance assessments.
Maltese: Fil-qosor, is-CHMP evalwa t-totalità tad-dejta disponibbli, inkluż it-tweġibiet sottomessi mill-MAHs bilmiktub u waqt spjegazzjoni orali, kif ukoll l-evalwazzjonijiet ta' farmakoviġilanza imwettqa fuq livell nazzjonali minn Franza.
English: One MAH suggested that further to the treatment duration restriction already implemented in France, the only way to reduce the number of voluntary overdose cases would be to restrict the use of the product to hospital-use only.
Maltese: MAH wieħed issuġġerixxa li minbarra r-restrizzjoni dwar it-tul tal-kura diġà implimentata fi Franza, l-uniku mod biex jitnaqqas innumru ta' każijiet ta' dożi eċċessivi volontarji kien li l-użu tal-prodott jiġi ristrett għall-użu fi sptar biss.
English: Regarding meprobamate-only products, the first Lille CPRV analysis identified 119 medically confirmed cases following the implementation of the risk minimisation measures, which was similar to the data for the period prior to the implementation, despite an assumed reduction in patient exposure, based on sales data.
Maltese: Fir-rigward ta' prodotti li kien fihom meprobamat biss, l-ewwel analiżi ta' Lille CPRV identifikat 119-il każ medikament ikkonfermat wara l-implimentazzjoni tal-miżuri għall-minimizzazzjoni tar-riskju, li kienu simili għad-dejta għall-perjodu ta' qabel l-implimentazzjoni, minkejja t-tnaqqis preżunt fl espożizzjoni tal-pazjenti, abbażi ta' dejta mill-bejgħ.
English: The CHMP also considered that meprobamate has a potential for pharmacodependence after prolonged use, leading to a risk of withdrawal symptoms which are serious and can be fatal.
Maltese: Is-CHMP ikkunsidra wkoll li meprobamat għandu potenzjal għal farmakodipendenza wara użu fit-tul, li jwassal għal riskju ta' sintomi ta' astinenza li huma serji u jistgħu jkunu fatali.
English: The analysis concluded that the reporting rate for meprobamate/aceprometazine did not decrease following the implementation of the risk minimisation measures.
Maltese: L-analiżi kkonkludiet li r-rata ta' rapportar għal meprobamat/aceprometazine ma naqsitx wara l-implimentazzjoni tal-miżuri għallminimizzazzjoni tar-riskju.
English: Finally, the CHMP was of the opinion that patients treated for alcohol withdrawal are at risk of potential serious adverse reactions due to impaired liver function.
Maltese: Fl-aħħar nett, is-CHMP kien tal-opinjoni li lpazjenti li kienu qegħdin jirċievu kura għall-astinenza mill-alkoħol qegħdin f'riskju ta' reazzjonijiet avversi serji potenzjali minħabba funzjoni indebolita tal-fwied.
English: Children 1 through 5 years of age: 2.5 ml (1.25 mg) Azomyr oral solution once a day.
Maltese: Tfal minn sena sa 5 snin : 2.5 ml (1.25 mg) Azomyr soluzzjoni orali darba kuljum.
English: Azomyr tablets contain lactose.
Maltese: Din il-mediċina fiha lactose.
English: Children 6 through 11 years of age: 5 ml (2.5 mg) Azomyr oral solution once a day.
Maltese: Tfal minn 6 snin sa 11-il sena: 5 ml (2.5 mg) Azomyr soluzzjoni orali darba kuljum.
English: Azomyr 0.5 mg/ml oral solution
Maltese: Azomyr 0.5 mg/ml soluzzjoni orali
English: Azomyr oral solution contains sorbitol
Maltese: Azomyr soluzzjoni orali fiha sorbitol
English: Azomyr 0.5 mg/ml oral solution desloratadine
Maltese: Azomyr 0.5 mg/ml soluzzjoni orali desloratadine
English: In infants and toddlers aged 6 to 23 months, the most frequent adverse reactions reported in excess of placebo were diarrhoea (3.7 %), fever (2.3 %) and insomnia (2.3 %).
Maltese: Fi trabi żgħar u tfal żgħar ta' etajiet minn 6 sa 23 xahar, l-aktar reazzjonijiet avversi frekwenti rrappurtati iżjed ta' spiss mill-plaċebo kienu dijarea (3.7%), deni (2.3%) u nuqqas ta' rqad (2.3%).
English: Azomyr contains lactose
Maltese: Azomyr fih lactose
English: Efficacy of Azomyr oral solution has not been investigated in separate paediatric trials.
Maltese: L-effikaċja tas-soluzzjoni orali Azomyr ma ġietx investigata fi provi pedjatriċi separati.
English: Azomyr oral solution, is supplied in 30, 50, 60, 100, 120, 150, 225 and 300 ml size Type III amber glass bottles closed with a plastic child resistant (C/R) screw closure having a multi-ply polyethylenefaced liner.
Maltese: Azomyr soluzzjoni orali, jiġi fi fliexken tal-ħġieġ kulur l-ambra tat-Tip III ta' daqsijiet ta' 30, 50, 60, 100, 120, 150, 225 u 300 ml, magħluqin b'għatu tal-plastik b'kamin li ma jistax jinfetaħ mit-tfal (C/R) li fih inforra b'ħafna saffi b'faċċata tal-polyethylene.
English: Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 tablets.
Maltese: Pakketti ta' 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 pillola.
English: Azomyr tablets effectively controlled symptoms for 24 hours.
Maltese: Azomyr ikkontrolla s-sintomi b'mod effettiv għal 24 siegħa.
English: Other medicines and Azomyr
Maltese: Mediċini oħra u Azomyr
English: Azomyr 5 mg film-coated tablets are packed in blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 or 100 tablets.
Maltese: Azomyr pilloli ta' 5 mg miksija b'rita huma ppakkjati f'folji f'pakketti ta' 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, jew 100 pillola.
English: 6.1 List of excipients sorbitol, propylene glycol, sucralose E 955, hypromellose 2910, sodium citrate dihydrate, natural and artificial flavour (bubblegum), citric acid anhydrous, disodium edetate, purified water
Maltese: sucralose E 955, hypromellose 2910, sodium citrate dihydrate, essenza naturali u artifiċjali (babbilgam), citric acid anhydrous, disodium edetate, ilma purifikat
English: EU/1/00/157/001 1 tablet EU/1/00/157/002 2 tablets EU/1/00/157/003 3 tablets EU/1/00/157/004 5 tablets EU/1/00/157/005 7 tablets EU/1/00/157/006 10 tablets EU/1/00/157/007 14 tablets EU/1/00/157/008 15 tablets EU/1/00/157/009 20 tablets EU/1/00/157/010 21 tablets EU/1/00/157/011 30 tablets EU/1/00/157/012 50 tablets EU/1/00/157/013 100 tablets
Maltese: EU/1/00/157/007 14-il pillola EU/1/00/157/008 15-il pillola EU/1/00/157/009 20 pillola EU/1/00/157/010 21 pillola EU/1/00/157/011 30 pillola EU/1/00/157/012 50 pillola EU/1/00/157/013 100 pillola
English: Azomyr 5 mg tablet desloratadine
Maltese: Azomyr pillola 5 mg desloratadine
English: Azomyr given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Maltese: Azomyr mogħti bħala doża waħda kuljum ta' 7.5 mg ma affettwax ilprestazzjonijiet psikomotorei fi provi kliniċi.
English: In a clinical pharmacology trial, Azomyr tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Maltese: Fi prova farmakoloġika klinika, pilloli Azomyr li ttieħdu flimkien mal-alkoħol ma żidux l-effetti talalkoħol li jxekkel il-prestazzjoni (ara sezzjoni 5.1).
English: Azomyr is indicated in adults, adolescents aged 12 years and older and children aged 6 - 11 years old for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1)
Maltese: Azomyr huwa indikat fl-adulti, fl-adolexxenti minn 12-il sena 'l fuq u tfal ta' bejn 6 u 11-il sena biex jittaffew is-sintomi assoċjati ma': - rinite allerġika (ara sezzjoni 5.1) - urtikarja (ara sezzjoni 5.1)
English: This product contains 2.9 mg of phenylalanine per 5 mg dose of Azomyr orodispersible tablet.
Maltese: Dan il-prodott fih 2.9 mg ta' phenylalanine għal kull doża ta' 5 mg ta' pillola li tinħall fil-ħalq Azomyr.
English: In the case of severe renal insufficiency, Azomyr should be used with caution (see section 5.2).
Maltese: F'każ ta' insuffiċjenza renali severa, Azomyr għandu jintuża b'attenzjoni (ara sezzjoni 5.2).
English: Azomyr 2.5 mg orodispersible tablet is light red, speckled, and round with “K” branded on one side.
Maltese: Azomyr 2.5 mg pillola li tinħall fil-ħalq hija ħamra ċara, ittikkjata, u tonda immarkata b'“K” fuq naħa.
English: EU/1/00/157/035 5 orodispersible tablets EU/1/00/157/036 6 orodispersible tablets EU/1/00/157/037 10 orodispersible tablets EU/1/00/157/038 12 orodispersible tablets EU/1/00/157/039 15 orodispersible tablets EU/1/00/157/040 18 orodispersible tablets EU/1/00/157/041 20 orodispersible tablets EU/1/00/157/042 30 orodispersible tablets EU/1/00/157/043 50 orodispersible tablets EU/1/00/157/044 60 orodispersible tablets EU/1/00/157/045 90 orodispersible tablets EU/1/00/157/046 100 orodispersible tablets
Maltese: EU/1/00/157/035 5 pilloli li jinħallu fil-ħalq EU/1/00/157/036 6 pilloli li jinħallu fil-ħalq EU/1/00/157/037 10 pilloli li jinħallu fil-ħalq EU/1/00/157/038 12-il pillola li jinħallu fil-ħalq EU/1/00/157/039 15-il pillola li jinħallu fil-ħalq EU/1/00/157/040 18-il pillola li jinħallu fil-ħalq EU/1/00/157/041 20 pillola li jinħallu fil-ħalq EU/1/00/157/042 30 pillola li jinħallu fil-ħalq EU/1/00/157/043 50 pillola li jinħallu fil-ħalq EU/1/00/157/044 60 pillola li jinħallu fil-ħalq EU/1/00/157/045 90 pillola li jinħallu fil-ħalq EU/1/00/157/046 100 pillola li jinħallu fil-ħalq
English: Adverse reactions seen with Azomyr
Maltese: Reazzjonijiet avversi li dehru b'Azomyr
English: Azomyr is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1)
Maltese: Azomyr huwa indikat fl-adulti u fl-adolexxenti minn 12-il sena 'l fuq biex jittaffew is-sintomi assoċjati ma': - rinite allerġika (ara sezzjoni 5.1) - urtikarja (ara sezzjoni 5.1)
English: In clinical studies with Azomyr, the following side effects were reported as:
Maltese: Fi studji kliniċi b'Azomyr, l-effetti sekondarji li ġejjin kienu rrappurtati bħala:
English: Azomyr orodispersible tablet is packed in unit dose blisters in packs of 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet.
Maltese: Azomyr pillola li tinħall fil-ħalq hi ppakkjata f'folji b'doża waħda f'pakketti ta' 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 u 100 doża ta' pilloli li jinħallu fil-ħalq.
English: In single-dose crossover studies of Azomyr 5 mg orodispersible tablets with Azomyr 5 mg conventional tablets, the formulations were bioequivalent.
Maltese: Fi studji crossover b'doża waħda ta' pilloli Azomyr 5 mg li jinħallu fil-ħalq ma' pilloli Azomyr 5 mg konvenzjonali, il-formulazzjonijiet kienu bijoekwivalenti.
English: Azomyr oral solution is available in bottles of 30, 50, 60, 100, 120, 150, 225 and 300 ml, with a childproof cap. For all packages except the 150 ml bottle, a measuring spoon is provided, marked for doses of 2.5 ml and 5 ml.
Maltese: Azomyr soluzzjoni orali , jiġi fi fliexken ta' daqsijiet ta' 30, 50, 60, 100, 120, 150, 225 u 300 ml magħluqin b'għatu tal-plastik mhux faċli biex jiftħuh it-tfal.
English: Azomyr tablets given at a single daily dose of 7.5 mg to adults and adolescents did not affect psychomotor performance in clinical trials.
Maltese: Il-pilloli Azomyr mogħtija bħala doża waħda kuljum ta' 7.5 mg lill-adulti u adolexxenti ma affettwawx il-prestazzjonijiet psikomotorei fi provi kliniċi.
English: At the recommended dose, Azomyr 5 mg orodispersible tablet was found to be bioequivalent to the Azomyr 5 mg conventional tablet formulation of desloratadine.
Maltese: Bid-doża rakkomandata, il-pillola Azomyr 5 mg li tinħall fil-ħalq instabet li hija bijoekwivalenti għallformulazzjoni tal-pillola Azomyr 5 mg konvenzjonali ta' desloratadine.
English: This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Azomyr orodispersible tablet.
Maltese: Dan il-prodott fih 1.4 mg phenylalanine għal kull doża ta' 2.5 mg ta' pillola li tinħall fil-ħalq Azomyr.
English: EU/1/00/157/047 5 orodispersible tablets EU/1/00/157/048 6 orodispersible tablets EU/1/00/157/049 10 orodispersible tablets EU/1/00/157/050 12 orodispersible tablets EU/1/00/157/051 15 orodispersible tablets EU/1/00/157/052 18 orodispersible tablets EU/1/00/157/053 20 orodispersible tablets EU/1/00/157/054 30 orodispersible tablets EU/1/00/157/055 50 orodispersible tablets EU/1/00/157/056 60 orodispersible tablets EU/1/00/157/057 90 orodispersible tablets EU/1/00/157/058 100 orodispersible tablets
Maltese: EU/1/00/157/047 5 pilloli li jinħallu fil-ħalq EU/1/00/157/048 6 pilloli li jinħallu fil-ħalq EU/1/00/157/049 10 pilloli li jinħallu fil-ħalq EU/1/00/157/050 12-il pillola li jinħallu fil-ħalq EU/1/00/157/051 15-il pillola li jinħallu fil-ħalq EU/1/00/157/052 18-il pillola li jinħallu fil-ħalq EU/1/00/157/053 20 pillola li jinħallu fil-ħalq EU/1/00/157/054 30 pillola li jinħallu fil-ħalq EU/1/00/157/055 50 pillola li jinħallu fil-ħalq EU/1/00/157/056 60 pillola li jinħallu fil-ħalq EU/1/00/157/057 90 pillola li jinħallu fil-ħalq EU/1/00/157/058 100 pillola li jinħallu fil-ħalq
English: Azomyr 2.5 mg tablets has not been evaluated in paediatric patients however in conjunction with the dose finding studies in paediatrics, the pharmacokinetics data for Azomyr orodispersible tablets supports the use of the 2.5 mg dose in paediatric patients 6 to 11 years of age.
Maltese: Il-pilloli Azomyr 2.5 mg ma ġewx evalwati f'pazjenti pedjatriċi, madankollu b'relazzjoni mal-istudji dwar is-sejbiet tad-doża fit-tfal, id-dejta farmakokinetika għall-pilloli li jinħallu fil-ħalq Azomyr tiffavorixxi l-użu tad-doża ta' 2.5 mg f'pazjenti pedjatriċi bejn 6 u 11-il sena.
English: Azomyr oral solution contains sorbitol.
Maltese: Azomyr soluzzjoni orali fiha sorbitol.
English: Azomyr is indicated in adults, adolescents and children over the age of 1 year for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1)
Maltese: Azomyr huwa indikat fl-adulti, fl-adolexxenti u fi tfal ta' aktar minn sena biex jittaffew is-sintomi assoċjati ma': - rinite allerġika (ara sezzjoni 5.1) - urtikarja (ara sezzjoni 5.1)
English: Azomyr tablets were effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Maltese: Azomyr kien effettiv biex iserraħ il-problemi relatati ma' rinite allerġika tal-istaġun kif jidher millpunteġġ totali tal-kwestjonarju fuq il-kwalità tal-ħajja b'rinokonġuntivite.
English: The efficacy of Azomyr tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Maltese: L-effikaċja tal-pilloli Azomyr ma ntwerietx b'mod ċar fi provi b'pazjenti adolexxenti minn 12 sa 17-il sena.
English: At the recommended dose, in clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic idiopathic urticaria, undesirable effects with Azomyr were reported in 3 % of patients in excess of those treated with placebo.
Maltese: Fid-doża rakkomandata, fi provi kliniċi li saru f'adulti u adolexxenti f'medda ta' indikazzjonijiet fosthom rinite allerġika u urtikarja idjopatika kronika, l-effetti mhux mixtieqa ta' Azomyr kienu rrappurtati fi 3% tal-pazjenti aktar minn dawk ikkurati bi plaċebo.
English: Azomyr 5 mg orodispersible tablet is light red, speckled, and round with “A” branded on one side.
Maltese: Azomyr 5 mg pillola li tinħall fil-ħalq hija ħamra ċara, ittikkjata, u tonda immarkata b'“A” fuq naħa.
English: Azomyr orodispersible tablet relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older.
Maltese: Azomyr itaffi s-sintomi assoċjati ma' rinite allerġika (infjammazzjoni tal-passaġġi fl-imnieħer ikkawżata minn allerġija, pereżempju hay fever jew allerġija għad-dust mites) fl-adulti u fl-adolexxenti minn 12-il sena 'l fuq.
English: Azomyr tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Maltese: Il-pilloli Azomyr mogħtija bħala doża waħda kuljum ta' 7.5 mg ma affettwawx il-prestazzjonijiet psikomotorei fi provi kliniċi.
English: Azomyr is an antiallergy medicine that does not make you drowsy.
Maltese: Azomyr hija mediċina kontra l-allerġiji li ma traqqdekx.
English: As a precautionary measure, it is preferable to avoid the use of Azomyr during pregnancy.
Maltese: Bћala prekawzjoni hu preferribli li ma jintużax Azomyr waqt it-tqala.
English: Azomyr 5 mg orodispersible tablets desloratadine
Maltese: Azomyr 5 mg pillola miksija b'rita desloratadine
English: How to store Azomyr
Maltese: X'fih Azomyr
English: Azomyr oral solution is an antiallergy medicine that does not make you drowsy.
Maltese: Azomyr soluzzjoni orali hija mediċina kontra l-allerġiji li ma traqqdekx.
English: Do not take Azomyr oral solution - if you are allergic to desloratadine, or to any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Maltese: Tiħux Azomyr soluzzjoni orali - jekk inti allerġiku għal desloratadine jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6) jew għal loratadine.
English: In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Azomyr tablets were reported in 3 % of patients in excess of those treated with placebo.
Maltese: Fi provi kliniċi ta' medda ta' indikazzjonijiet fosthom rinite allerġika u urtikarja idjopatika kronika, bid-doża rakkomandata ta' 5 mg kuljum, l-effetti mhux mixtieqa b'Azomyr kienu rrappurtati fi 3% talpazjenti aktar minn dawk ikkurati bi plaċebo.
English: In adult and adolescent patients with allergic rhinitis, Azomyr tablets were effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Maltese: F'pazjenti adulti u adolexxenti b'rinite allerġika, il-pilloli Azomyr kienu effettivi biex iserrħu sintomi bħal għatis, tnixxija mill-imnieħer u ħakk, kif ukoll ħakk, dmugħ u ħmura fl-għajnejn, u ħakk fis-saqaf tal-ħalq.
English: Each dose of orodispersible tablet contains 2.5 mg desloratadine.
Maltese: Kull doża ta' pillola li tinħall fil-ħalq fiha 2.5 mg desloratadine.
English: Ledaga is a ‘hybrid medicine'.
Maltese: Ledaga huwa “mediċina ibrida”.
English: The medicine contains the active substance chlormethine.
Maltese: Il-mediċina fiha ssustanza attiva chlormethine.
English: The full EPAR for Ledaga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Ledaga
Maltese: Informazzjoni oħra dwar Ledaga
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ledaga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Ledaga jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Ledaga was effective in 58% of patients (76 patients out of 130) after at least 6 months of treatment compared with 48% of patients (62 out of 130) using the ointment.
Maltese: Ledaga kien effettiv fi 58 % tal-pazjenti (76 pazjent minn 130) wara tal-inqas 6 xhur ta' kura meta mqabbel ma' 48 % tal-pazjenti (62 minn 130) li użaw l-ingwent.
English: Because the number of patients with this skin cancer is low, the disease is considered ‘rare', and Ledaga was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2012.
Maltese: Peress li n-numru ta' pazjenti li għandhom il-kanċer tal-ġilda huwa baxx, il-marda hija kkunsidrata bħala “rari”, u Ledaga ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit22 ta' Mejju 2012.
English: This is a summary of the European public assessment report (EPAR) for Ledaga.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ledaga.
English: What are the risks associated with Ledaga?
Maltese: X'inhuma r-riskji assoċjati ma' Ledaga?
English: Why is Ledaga approved?
Maltese: Għaliex ġie approvat Ledaga?
English: The active substance in Ledaga, chlormethine, belongs to the group of cancer medicines called ‘alkylating agents'.
Maltese: Is-sustanza attiva f'Ledaga, chlormethine, tappartjeni għal grupp ta' mediċini tal-kanċer li jissejħu “aġenti alkilanti”.
English: The ointment's effectiveness was considered comparable to that of the reference medicine, Caryolysine.
Maltese: L-effettività tal-ingwent kienet ikkunsidrata bħala komparabbli ma' dik tal-mediċina ta' referenza, Caryolysine.
English: The most common side effects with Ledaga (which may affect more than 1 in 10 people) are dermatitis (skin inflammation with reddening, rash, pain and burning sensation), skin infection and itching.
Maltese: L-effetti sekondarji l-aktar komuni b'Ledaga (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma dermatite (infjammazzjoni tal-ġilda bi ħmura, raxx, uġigħ u sensazzjoni ta' ħruq), infezzjoni tal-ġilda u ħakk.
English: In addition, a study involving 260 patients found that Ledaga was at least as effective as an ointment containing the same amount of chlormethine.
Maltese: Barra minn hekk, studju li involva 260 pazjent sab li Ledaga kien tal-inqas effettiv daqs ingwent li jkun fih l-istess ammont ta' chlormethine.
English: Ledaga is a medicine used to treat adults with a skin cancer called mycosis fungoides-type cutaneous T-cell lymphoma.
Maltese: Ledaga hija mediċina li tintuża biex tikkura adulti b'kanċer tal-ġilda li jissejjaħ limfoma taċ-ċellula T filġilda tat-tip mikosi fungojdi (mycosis fungoides-type cutaneous T-cell lymphoma).
English: The difference between Ledaga and Caryolysine is that Ledaga is available as a gel and Caryolysine was available as a liquid for diluting before applying to the skin.
Maltese: Id-differenza bejn Ledaga u Caryolysine hi li Ledaga jiġi bħala ġel u Caryolysine jiġi bħala likwidu għad-dilwizzjoni qabel jiġi applikat fuq il-ġilda.
English: The company provided data from the published literature showing that chlormethine, the active substance in Ledaga, is effective in treating mycosis fungoides-type cutaneous T-cell lymphoma.
Maltese: Il-kumpanija pprovdiet dejta minn dokumentazzjoni ppubblikata li turi li chlormethine, is-sustanza attiva f'Ledaga, hija effettiva fil-kura ta' limfoma taċ-ċellula T fil-ġilda tat-tip mikosi fungojdi.
English: How is Ledaga used?
Maltese: Kif jaħdem Ledaga?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ledaga has shown comparable safety and effectiveness to Caryolysine and has shown satisfactory quality.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li Ledaga wera li għandu sigurtà u effettività komparabbli għal Caryolysine u wera li għandu kwalità sodisfaċenti.
English: This means that it is similar to a ‘reference medicine' (in this case Caryolysine) containing the same active substance and used for the same purpose.
Maltese: Dan ifisser li huwa simili għal “mediċina ta' referenza” (f'dan il-każ Caryolysine) li fiha l-istess sustanza attiva u li tintuża għall-istess skop.
English: Local investigator laBCC
Maltese: Investigatur lokali laBCC
English: Sonidegib is a competitive inhibitor of CYP2B6 and CYP2C9 in vitro.
Maltese: Sonidegib hu inibitur kompettiv ta' CYP2B6 u CYP2C9 in vitro.
English: The size of the capsule is “Size #00” (dimensions 23.3 x 8.53 mm).
Maltese: Id-daqs tal-kapsula hu “Daqs#00” (qisien 23.3 x 8.53 mm).