FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 1.0 mg tacrolimus (as monohydrate),
Maltese: 1 g ingwent fih: 1.0 mg tacrolimus (bħala monohydrate),
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPY 0.03% OINTMENT (30 g, 60 g TUBE)
Maltese: IŻ-ŻAGĦAR EWLENIN PROTOPY 0.03% INGWENT (10 g TUBU)
English: One gram of Protopy 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
Maltese: Gramma waħda ta' Protopy 0.1% ingwent fiha 1.0 mg tacrolimus (bħala tacrolimus monohydrate).
English: The results of this multicentre, double-blind, randomised trial showed that tacrolimus ointment, 0.03% and 0.1%, is significantly more effective (p<0.001 for both) than 1% hydrocortisone acetate ointment (Table 2).
Maltese: Ir-riżultati ta' din il-prova double blind u randomised, urew li tacrolimus ingwent f' konċentrazzjoni ta' 0.03% u ta' 0.1% hu sinifikament aktar effettiv (p<0.
English: Patients with atopic dermatitis are predisposed to superficial skin infections.
Maltese: Pazjenti b' dermatite atopika jista' jkollom ukoll infezzjoni superfiċjali tal-ġilda.
English: In patients using tacrolimus ointment, cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers have been reported (see section 4.8).
Maltese: F'pazjenti li jużaw lingwent tacrolimus, kien hemm rapportati każi ta' malinjitajiet, inklużi l-limfoma fil-ġilda u tipi oħra ta' limfoma, kif ukoll kanċer tal-ġilda (ara sezzjoni 4.8).
English: Cutaneous use
Maltese: Rosaċeja
English: In both adults and children with an average of 50% body surface area treated, systemic exposure (i.e. AUC) of tacrolimus from Protopy is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
Maltese: Fi kbar u fi tfal b'medja ta' 50% tal-ġilda trattata, l-esponiment fiċ-ċirkolazzjoni tad-demm (i.e. AUC) ta' tacrolimus minn Protopy hu madwar 30% inqas minn dak ta' mediċina immunosuppressiva li tingħata mill-ħalq lill pazjenti li kellhom trapjant ta' kilwa jew fwied.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
Maltese: U KWANTITATTIVA 1 g ta' Protopy 0.1% ingwent fih 1.0 mg ta' Tacrolimus bħala tacrolimus monohydrate (0.1%).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPY 0.1% OINTMENT (10 g TUBE)
Maltese: IŻ-ŻAGĦAR EWLENIN PROTOPY 0.1% INGWENT (10 g TUBU)
English: INFORMATION IN BRAILLE Protopy 0.03%
Maltese: Protopy 0.03% ingwent
English: Astellas Pharma S.A.
Maltese: Astellas Pharma AB
English: STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 0.3 mg tacrolimus (as monohydrate),
Maltese: 1 g ingwent fih: 0.3 mg tacrolimus (bħala monohydrate),
English: София 1407
Maltese: A-1140
English: INFORMATION IN BRAILLE Protopy 0.1%
Maltese: Protopy 0.1% ingwent
English: Patients with atopic dermatitis treated with Protopy have not been found to have significant systemic tacrolimus levels.
Maltese: Ma nstabx li dawk il-pazjenti b'dermatite atopika kkurati bi Protopy kellhom livelli sistemiċi sinifikanti ta' tacrolimus.
English: 10 g
Maltese: SI-1000
English: The primary endpoint was the response rate at month 3 defined as the proportion of patients with at least 60% improvement in the mEASI (modified Eczema Area and Severity Index) between baseline and month 3.
Maltese: L-ewwel punt ta' levalwazzjoni kienet ir-rispons kliniku wara tlett xhur, definita bħala il-proporz tal-pazjenti li għaddew għall-aħjar b' mill-anqas 60% skond l-mEASI (modified Eczema Area and Severity Index) bejn il-bidu ta' l-esperiment u kif skadew 3 xhur.
English: Rosacea and rosacea-like dermatitis have also been reported.
Maltese: Kien hemm ukoll każi ta' rosaċeja u dermatite bħal rosaċeja rrappurtati.
English: Long-term topical treatment of rats with tacrolimus led to systemic toxicity including alterations of kidneys, pancreas, eyes and nervous system.
Maltese: Meta tacrolimus ingħata fit-tul fuq il-ġilda tal-firien, dawn kellhom sinjali ta' tossiċità fis-sistema ġenerali b' tibdil fil-kliewi, pankrejas, għajnejn u s-sistema nervuża.
English: Systemic exposure from topical application of tacrolimus ointment is low (< 1.0 ng/ml) and is unlikely to be affected by concomitant use of substances known to be inhibitors of CYP3A4.
Maltese: Ilkonċentrazzjoni ta' tacrolimus fid-demm wara użu fuq il-ġilda hi baxxa (inqas minn 1.0 ng/ml) u għalhekk ma tiġiex affettwata minn sustanzi kontra CYP3A4.
English: Paseo del Club Deportivo n° 1 Bloque 14-2a
Maltese: Rua José Fontana, n.°1, 1°Andar
English: Acne is an uncommon side effect.
Maltese: Dawn l-effetti għadhom ma ġewx studjati.
English: SK-831 03 Bratislava Tel: +421 2 4444 2157
Maltese: Tel: +421 2 4444 2157
English: These may include monitoring of vital signs and observation of clinical status.
Maltese: Dan jista' jinkludi monitoraġġ tassinjali vitali u ħarsien ta' l-istat kliniku tal-pazjent.
English: In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application.
Maltese: Madwar 50% tal-pazjenti kellhom xi tip ta' irritazzjoni avversa tal-ġilda fil-parti fejn ġie applikat lingwent.
English: White beeswax
Maltese: Lietuva UAB
English: In a six-month multicentre double-blind randomised trial, 0.1% tacrolimus ointment was administered twice-a-day to adults with moderate to severe atopic dermatitis and compared to a topical corticosteroid based regimen (0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck).
Maltese: Fi prova li ħa sitt xhur, li sar f' aktar minn ċentru wiehed u li kien tat-tip "double blind randomised" 0.1% Protopy ingwent ingħata darbtejn kuljum lil pazjenti kbar li kienu jsofru b' dermatite atopika ta' qawwa moderata għal qalila.
English: Other common (> 1%) side effects are redness, feeling of warmth, pain, increased skin sensitivity (especially to hot and cold), skin tingling, rash, folliculitis (inflamed or infected hair follicles) and herpes viral infections (e.g. cold sores, generalised herpes simplex infections).
Maltese: Dawn is-sintomi huma ħfief għal moderati u ġeneralment jgħaddu wara xi ġimgħa li jintuża Protopy. Effetti oħra li huma komuni (> 1%) huma ħmura, ħruq ħafif, uġigħ, żjieda tas-sensività tal-ġilda għall-kesħa u għas-sħana, tingiż, fawra, infjammazzjoni tax-xagħar u infezzjoni bil-virus ta' herpes (ħżiża lokalizzata jew ġeneralizzata).
English: Results from clinical studies in patients
Maltese: Riżultati ta' studji kliniċi fuq pazjenti
English: Before commencing treatment with Protopy ointment, clinical infections at treatment sites should be cleared.
Maltese: Barra minn hekk, ma kienx hemm evidenza li l-effiċenza tat-trattament tnaqqset waqt il-prova klinika.
English: The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period.
Maltese: L-ewwel punt ta' l-evalwazzjoni kienet l-erja taħt ilkurva (AUC = area under the curve) tal-mEASI bħala persentaġġ tal-valur bażi fuq it-tul tat-trattament.
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 xahar) u firien (24 xahar) urew li tacrolimus m'għandux
English: EXPIRY DATE EXP: {MM/YYYY}
Maltese: FULJETT TA' TAGĦRIF:
English: The three most common adverse events reported were flu-like symptoms (cold, common cold, influenza, upper respiratory infection, etc.), pruritus and skin burning.
Maltese: It-tliet effetti mhux mixtieqa, li kienu l-aktar komuni, kienu sintomi bħal ta' l-influwenza (riħ, riħ komuni, influwenza, infezzjoni tan-naħa ta' fuq ta' l-apparat respiratorju eċċ.), ħakk u ħruq tal-ġilda.
English: Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3).
Maltese: L-istudji fuq l-annimali wrew tossiċità riproduttiva wara li ngħata sistemikament (ara sezzjoni 5.3). Ir-riskju li jista' jkun
English: Repeated topical administration of tacrolimus ointment or the ointment vehicle to rats, rabbits and micropigs was associated with slight dermal changes such as erythema, oedema and papules.
Maltese: Protopy forma ta' ingwent jista' jiġi użat f' kull parti tal-ġisem, inklużi l-wiċċ, l-għonq, u partijiet fejn il-ġilda tintlewa, minbarra membrani mukużi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA PROTOPY 0.03% INGWENT (10 g, 30 g, 60 g KARTUN)
English: Protopy 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids.
Maltese: L-ingwent Protopy 0.03% jintuża biex jikkura dermatite atopika moderata għal severa (ekżema) filkbar li ma jkunux adegwatament responsivi għal jew intolleranti mill-kuri konvenzjonali bħala ma huma il-kortikosterojdi topikali u fit-tfal (ta' sentejn jew akbar) li kura konvenzjonali bħalama huma ilkortikosterojdi topikali ma ħadmitx fuqhom biżżejjed.
English: Hard paraffin
Maltese: TAGĦRIF
English: In a photocarcinogenicity study, albino hairless mice were chronically treated with tacrolimus ointment and UV radiation.
Maltese: Fi studju dwar il-fotokanċeroġeniċità, tacrolimus ingwent u raġġi ta' l-UV ingħataw f'daqqa għal żmien twil ħafna fuq ġrieden albino bla xaghar.
English: D-81673 München
Maltese: SK-831 03 Bratislava
English: 5.3 Preclinical safety data
Maltese: 2. GĦAMLA KWALITATTIVA
English: In this leaflet:
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq:
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għall
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA PROTOPY 0.1% INGWENT (10 g, 30 g, 60 g KARTUN)
English: Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Tubu li fuq ġewwa għandu saff ta' low density polyethylene u li għandu kappa bajda b'kamin talpropylene.
English: Post-marketing: cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using tacrolimus ointment (see section 4.4).
Maltese: Wara t-tqegħid fuq is-suq: f'pazjenti li kienu qed jużaw l-ingwent tacrolimus kien hemm każijiet ta' xi malinjitajiet fil-ġilda u tipi oħra ta' limfoma, kif ukoll kanċer tal-ġilda (ara sezzjoni 4.4).
English: Protopy is available in two strengths, Protopy 0.03% and Protopy 0.1% ointment.
Maltese: Wieħed għandu jipprova inaqqas il-frekwenza ta' l-użu, jew juża Protopy 0.03%, jekk il-kondizzjoni klinika tippermetti.
English: Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin with minimal diffusion into the systemic circulation.
Maltese: Meta tacrolimus ingwent jigi applikat lokalment, tacrolimus jgħaddi selettivament fil-ġilda, waqt li iddiffużjoni fiċ-ċirkolazzjoni tad-demm hi minima.
English: Because of the potential risk of vaccination failure, vaccination should be administered prior to commencement of treatment, or during a treatment-free interval with a period of 14 days between the last application of Protopy and the vaccination.
Maltese: Minħabba li ttilqima tista' ma tirnexxix, it-tilqima għandha ssir qabel tibda t-trattament bi Protopy, jew inkella f' perijodu meta t-trattament bi Protopy tkun imwaqqfa u jkun hemm intervall ta' 14-il ġurnata bejn Protopy u t-tilqima.
English: Application site warmth, application site erythema, application site pain, application site irritation, application site paraesthesia, application site rash
Maltese: Ħafna drabi seħħew ukoll sensazzjoni ta' sħana, uġigħ, paraesthesia (wieħed ma jkunx iħoss) u raxx fil-partijiet fejn ġie applikat l-ingwent.
English: The majority of these cases related to infections (skin, respiratory tract, tooth) and resolved with appropriate antibiotic therapy.
Maltese: Il-biċċa 'l kbira kellhom x' jaqsmu ma' infezzjonijiet (tal-ġilda, ta' l-apparat respiratorju, u tas-snien) u tfejjqu b' trattament antibijotika xierqa.
English: 22 September 2011
Maltese: 22 ta' Settembru 2011
English: What is Canazole?
Maltese: X'inhu Canazole?
English: Canazole is a cream that contains the active substance clotrimazole (1%).
Maltese: Canazole huwa krema li fiha s-sustanza attiva clotrimazole (1%).
English: Pinewood Laboratories Ltd submitted Canazole for mutual recognition on the basis of the initial authorisation granted by Ireland on 8 December 2000.
Maltese: Pinewood Laboratories Ltd issottomettiet lil Canazole għal rikonoxximent reċiproku abbażi talawtorizzazzjoni inizjali mogħtija mill-Irlanda fit-8 ta' Diċembru 2000.
English: The active substance in Canazole, clotrimazole, is an antifungal medicine that belongs to the group called triazoles.
Maltese: Is-sustanza attiva f'Canazole, clotrimazole, hija mediċina antifungali li tagħmel parti mill-grupp imsejjaħ triazoles.
English: Questions and answers on Canazole (clotrimazole cream 1%) EMA/837098/2011
Maltese: Mistoqsijiet u tweġibiet dwar Canazole (krema clotrimazole 1%) EMA/206825/2011
English: However, the Member States were not able to reach an agreement and the Irish medicines regulatory agency referred the matter to the CHMP for arbitration on 25 November 2010.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu ftehim u l-aġenzija regolatorja tal-mediċini Irlandiża rreferiet il-kwistjoni lis-CHMP għall-arbitraġġ fil-25 ta' Novembru 2010.
English: It is used to treat skin infections caused by fungi, such as thrush, ringworm or athlete's foot.
Maltese: Tintuża fil-kura ta' infezzjonijiet talġilda kkawżati minn fungi, bħal truxx, ħżieża jew fungu li jattakka s-sieq (athlete's foot).
English: Questions and answers on Canazole (clotrimazole cream
Maltese: Mistoqsijiet u tweġibiet dwar Canazole (krema clotrimazole 1%)
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Canazole.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Canazole.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the currently available data were not sufficient to show therapeutic equivalence with the reference medicine and that further data would need to be generated.
Maltese: Abbażi tal-evalwazzjoni tad-dejta disponibbli attwalment u d-diskussjoni xjentifika fi ħdan il-Kumitat, is-CHMP ikkonkluda li d-dejta attwalment disponibbli ma kinitx suffiċjenti biex turi ekwivalenza terapewtika mal-mediċina ta' referenza u li hemm il-ħtieġa li tiġi ġġenerata aktar dejta.
English: Canazole is a generic medicine based on a ‘reference medicine', Canesten, which is authorised in the United Kingdom.
Maltese: Mingħajr ergosterol, il-fungu jinqatel jew jinżamm milli jinfirex. Canazole huwa mediċina ġenerika bbażata fuq ‘mediċina ta' referenza', Canesten, li hija awtorizzata fir-Renju Unit.
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Maltese: Taħdem billi tipprevjeni l-formazzjoni ta' ergosterol, li huwa parti importanti talħitan taċ-ċelloli fungali.
English: The CHMP therefore concluded that the benefits of Canazole do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member State.
Maltese: Għalhekk, isCHMP ikkonkluda li l-benefiċċji ta' Canazole ma jegħlbux ir-riskji tiegħu u rrakkomanda li lawtorizzazzjoni għat-tqegħid fis-suq ma għandhiex tingħata fl-Istat Membru kkonċernat.
English: The grounds for the referral were that the United Kingdom did not agree that Canazole cream and Canesten cream are similar enough to have therapeutic equivalence.
Maltese: Ir-raġunijiet għar-riferiment kienu għaliex ir-Renju Unit ma qabilx li l-krema Canazole u l-krema Canesten huma simili biżżejjed biex ikollhom ekwivalenza terapewtika.
English: The marketing authorisation in Ireland should also be suspended.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq fl-Irlanda għandha tiġi sospiża wkoll.
English: In addition, the Committee has also recommended that the marketing authorisation for Canazole in Ireland be suspended until further studies are done.
Maltese: Barra minn hekk, il-Kumitat irrakkomanda wkoll li l-awtorizzazzjoni għat-tqegħid fis-suq għal Canazole fl-Irlanda tiġi sospiża sakemm isiru aktar studji.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Canazole do not outweigh its risks, and the marketing authorisation granted in Ireland cannot be recognised in other Member States of the EU.
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ikkonkluda li l-benefiċċji ta' Canazole mhumiex akbar mir-riskji tiegħu, u l-awtorizzazzjoni għat-tqegħid fis-suq mogħtija fl-Irlanda ma tistax tiġi rikonoxxuta fi Stati Membri oħra tal-UE.
English: Ref.: EMEA/528144/2009 EMEA/H/C/535
Maltese: EMEA/528144/2009 EMEA/H/C/535
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 1884 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 1884 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
English: It is available as capsules (blue: 25 mg; orange: 50 mg).
Maltese: Tiġi bħala kapsuli (blu: 25 mg; oranġjo: 50 mg).
English: Other information about Wilzin:
Maltese: Informazzjoni oħra dwar Wilzin:
English: Doc.
Maltese: Wilzin?
English: Wilzin zinc EPAR summary for the public
Maltese: Wilzin żingu Sommarju tal-EPAR għall-pubbliku
English: The marketing authorisation was renewed on 13 October 2009.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-13 ta' Ottubru 2009.
English: The most common side effects with Wilzin (seen in between 1 and 10 patients in 100) are gastric irritation (irritation of the stomach) and increased blood levels of enzymes (amylase, lipase and alkaline phosphatase).
Maltese: L-effetti sekondarji l-aktar komuni b'Wilzin (li dehru f'bejn pazjent 1 u 10 minn kull 100) huma lirritazzjoni gastrika (irritazzjoni tal-istonku) u żieda fil-livelli ta' enzimi fid-demm (amylase, lipase u alkaline phosphatase).
English: The summary of opinion of the Committee for Orphan Medicinal Products for Wilzin is available here.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għal Prodotti Mediċinali Orfni għal Wilzin huwa disponibbli hawnhekk.
English: Because the number of patients with Wilson's disease is low, the disease is considered ‘rare', and Wilzin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 31 July 2001.
Maltese: Minħabba li n-numru ta' pazjenti li għandhom il-marda ta' Wilson huwa wieħed baxx, dan il-mard huwa kkunsidrat bħala ‘rari', u Wilzin ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fil-31 ta' Lulju 2001.
English: Wilzin is a medicine that contains the active substance zinc.
Maltese: Wilzin huwa mediċina li fiha s-sustanza attiva żingu.
English: The maximum dose of Wilzin is 50 mg five times a day.
Maltese: Id-doża massima ta' Wilzin hija ta' 50 mg ħames darbiet kuljum.
English: The usual dose for adults is 50 mg three times a day.
Maltese: Id-doża normali għall-adulti hija ta' 50 mg tliet darbiet kuljum.
English: In the main study, 91% of the patients evaluated (91 out of 100) had adequate control of their copper levels within the first year of treatment with Wilzin.
Maltese: Fl-istudju ewlieni, 91% tal-pazjenti li ġew evalwati (91 minn 100) kellhom kontroll adegwat tal-livelli tar-ram tagħhom fl-ewwel sena ta' trattament b'Wilzin.
English: In total, data to support the use of Wilzin came from 255 patients with Wilson's disease.
Maltese: B'kollox, id-dejta li tappoġġja l-użu ta' Wilzin ġiet minn 255 pazjent bil-marda ta' Wilson.
English: What is the risk associated with Wilzin?
Maltese: X'inhu r-riskju assoċjat ma' Wilzin?
English: Why has Wilzin been approved?
Maltese: Għaliex ġie approvat Wilzin?
English: What is Wilzin?
Maltese: X'inhu Wilzin?
English: Wilzin is a long-term treatment.
Maltese: Wilzin huwa trattament fuq żmien twil.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Wilzin to Orphan Europe SARL on 13 October 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq madwar l-Unjoni Ewropea għal Wilzin lil Orphan Europe SARL fit-13 ta' Ottubru 2004.
English: The active substance in Wilzin is the zinc cation (positively charged zinc), which blocks the absorption of copper from the diet.
Maltese: Is-sustanza attiva f'Wilzin hija il-katjonu taż-żingu (żingu b'ċarġ pożittiv), li timblokka l-assorbiment tar-ram mid-dieta.
English: The main study involved 148 patients who were treated with Wilzin, but did not compare Wilzin with any other treatments.
Maltese: L-istudju ewlieni kien jinvolvi 148 pazjent li ġew ikkurati b'Wilzin, iżda ma qabbilx Wilzin ma' kura oħra.
English: Zinc has been used to treat Wilson's disease since 1958.
Maltese: Iż-żingu ilu jintuża fil-kura tal-marda ta' Wilson mill-1958.
English: Gastric irritation is usually worst with the first morning dose and disappears after the first few days of treatment.
Maltese: Normalment, l-irritazzjoni gastrika tkun l-agħar mal-ewwel doża ta' filgħodu u tisparixxi wara l-ewwel ftit jiem ta' trattament.
English: It works by stimulating the body to produce a protein called metallothionein in the cells lining the gut.
Maltese: Din taħdem billi tistimola lill-ġisem biex jipproduċi proteina msejħa metallothionein fiċ-ċelloli li jiksu l-intestini.
English: How has Wilzin been studied?
Maltese: Kif ġie studjat Wilzin?
English: Therefore, the Committee decided that Wilzin's benefits are greater than its risks for the treatment of Wilson's disease.
Maltese: Għalhekk, il-Kumitat iddeċieda li l-benefiċċji ta' Wilzin huma ikbar mir-riskji tiegħu għat-trattament tal-marda ta' Wilson.
English: What benefit has Wilzin shown during the studies?
Maltese: Liema benefiċċju wera Wilzin waqt l-istudji mwettqa?
English: This causes a variety of effects, including liver disease and damage to the nervous system.
Maltese: Dan jikkawża firxa ta' effetti, inkluż il-mard tal-fwied u l-ħsara fissistema nervuża.
English: For the full list of all side effects reported with Wilzin, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji kollha rrappurtata b'Wilzin, ara l-Fuljett ta' Tagħrif.
English: Patients who are switching from a ‘chelating agent' (another type of medicine for Wilson's disease) to Wilzin should continue to take the chelating agent for two to three weeks after starting Wilzin, because Wilzin takes some time to start working fully.
Maltese: Il-pazjenti li jkunu qegħdin jaqilbu minn ‘sustanza kelanti' (tip ieħor ta' mediċina għall-marda ta' Wilson) għal Wilzin għandhom ikomplu jieħdu s-sustanza kelanti għal ġimagħtejn sa tliet ġimgħat wara li jibdew Wilzin, minħabba li Wilzin jieħu xi ftit tal-ħin biex jibda jaħdem għal kollox.
English: For more information, see the Package Leaflet.
Maltese: Għal aktar informazzjoni, ara l-Fuljett ta' Tagħrif.
English: b C.I., confidence interval.
Maltese: b C.I., intervall ta' konfidenza.
English: Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Maltese: Teva B.V., Swensweg 5, 2031GA Haarlem, L-Olanda
English: Teva Pharmaceuticals Ireland L-Irlanda
Maltese: Teva Pharmaceuticals Ireland
English: Iron oxide yellow
Maltese: Iron oxide isfar
English: Date of first authorisation: 9 January 2012 Date of latest renewal: 9 September 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 9 ta' Jannar 2012 Data tal-aħħar tiġdid: 9 ta' Settembru 2016