FrancophonIA/ELRC3.0 huggingface dataset:
English: The procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh), under Article 13(1), paragraph 1 of Regulation EC No 1234/2008 by Sweden on 21 August 2018.
Maltese: Il-proċedura ġiet riferuta lill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura DeċentralizzataBniedem (CMDh), skont l-Artikolu 13(1), il-paragrafu 1 tar-Regolament KE Nru 1234/2008 mill-Iżvezja fil-21 ta' Awwissu 2018.
English: Furthermore, the CHMP considered that the submitted in-vitro studies had several methodological limitations including the absence of a positive control, the duration, and the high heterogeneity among the donors.
Maltese: Barra minn hekk, isCHMP ikkunsidra li l-istudji in-vitro sottomessi kellhom diversi limitazzjonijiet metodoloġiċi inkluż innuqqas ta' kontroll pożittiv, it-tul ta' żmien, u l-livell għoli ta' eteroġeneità fost id-donaturi.
English: • The Committee considered the supportive clinical data of another medicinal product containing benzoyl peroxide 2.5% in combination with adapalene 0.1%, in a vehicle containing Simulgel 600 PHA, and concluded that data of the reformulated Basiron AC gels 5% w/w and 10% w/w could not be extrapolated from the dossier of another product in view of qualitative and quantitative differences between Basiron AC gels 5% w/w and 10% w/w and the other medicinal product;
Maltese: PHA, u kkonkluda li d-data ta' Basiron AC ġellijiet 5% w/w u 10% w/w irriformulati ma setgħetx tiġi estrapolata mid-dossier ta' prodott ieħor fid-dawl tad-differenzi kwalitattivi u kwantitattivi bejn Basiron AC ġellijiet 5% w/w u 10% w/w u l-prodott mediċinali l-ieħor;
English: However, in support of this application neither clinical data nor validated non-clinical data have been submitted.
Maltese: Madankollu, b'appoġġ għal din l-applikazzjoni la tressqet data klinika u lanqas data mhux klinika validata.
English: There may be differences in absorption and stability of the active substance between the Epiduo and the new Basiron formulation, which cannot be determined in the absence of relevant data for Basiron.
Maltese: Jista' jkun hemm differenzi fl-assorbiment u fl-istabbiltà tas-sustanza attiva bejn il-formulazzjoni ta' Epiduo u dik ġdida ta' Basiron, li ma jistgħux jiġu ddeterminati fin-nuqqas ta' data rilevanti għal Basiron.
English: In the clinical studies performed in support of the Epiduo gel, approximately 2500 subjects above 9 years of age were exposed to Simulgel 600 PHA.
Maltese: Fl-istudji kliniċi li saru b'appoġġ għall-ġell Epiduo, madwar 2500 individwu li għandhom 'il fuq minn 9 snin ġew esposti għal Simulgel 600
English: • The Committee reviewed the available data submitted in support of the new formulation of Basiron containing the new gelling agent excipient Simulgel 600 PHA;
Maltese: • Il-Kumitat irreveda d-data disponibbli sottomessa b'appoġġ għall-formulazzjoni l-ġdida ta' Basiron li fih l-eċċipjent tal-ġelifikant il-ġdid Simulgel 600
English: In absence of clinical data, non-clinical validated models can be accepted.
Maltese: Fin-nuqqas ta' data klinika, jistgħu jiġu aċċettati mudelli vvalidati mhux kliniċi.
English: Taking into consideration the qualitative and quantitative differences between Epiduo gel and the re-formulated Basiron, it cannot be concluded based on the data provided that the data from Epiduo gel can be extrapolated to the new formulation of Basiron AC
Maltese: Filwaqt li jitqiesu d-differenzi kwalitattivi u kwantitattivi bejn Epiduo ġell u Basiron irriformulat, ma jistax jiġi konkluż abbażi tad-data pprovduta li d-data minn Epiduo ġell tista' tiġi estrapolata għall-formulazzjoni l-ġdida ta' Basiron AC
English: • The Committee noted that the in-vitro tests indicated differences between the marketed formulation and the new proposed formulation containing the new gelling agent Simulgel 600 PHA.
Maltese: • Il-Kumitat innota li t-testijiet in-vitro indikaw differenzi bejn il-formulazzjoni mqiegħda fis-suq u lformulazzjoni proposta ġdida li fiha l-ġelifikant il-ġdid Simulgel 600
English: Day 60 of the CMDh procedure was on 25 October 2018 and as no agreement amongst member states could be reached, Sweden notified the European Medicines Agency on 26 October 2018 of a referral under Article 13 of Regulation EC No 1234/2008.
Maltese: Jum 60 tal-proċedura tas-CMDh kien fil-25 ta' Ottubru 2018 u peress li ma seta' jintlaħaq l-ebda ftehim bejn l-Istati Membri, l-Iżvezja nnotifikat lill-Aġenzija Ewropea għall-Mediċini fis-26 ta' Ottubru 2018 dwar riferiment skont l-Artikolu 13 tar-Regolament KE Nru 1234/2008.
English: • The Committee noted the absence of clinical data generated with the reformulated product containing the gelling agent excipient Simulgel 600 PHA for Basiron and associated names;
Maltese: • Il-Kumitat innota n-nuqqas ta' data klinika ġġenerata permezz ta' prodott irriformulat li fih leċċipjent tal-ġelifikant Simulgel 600
English: Moreover the Committee noted that the in-vitro tests used were not validated for the therapeutic situation and that they had several methodological limitations.
Maltese: Barra minn hekk, ilKumitat innota li t-testijiet in-vitro li ntużaw ma kinux ivvalidati għas-sitwazzjoni terapewtika u li kellhom diversi limitazzjonijiet metodoloġiċi.
English: Cashel Road, Dublin 12, Ireland.
Maltese: Cashel Road, Dublin 12, L-Irlanda.
English: Date opened: ____________________
Maltese: Data meta nfetaħ: ____________________
English: Effects on endocrine system
Maltese: Effetti fuq is-sistema endokrinali
English: ATC Code: D05AX52
Maltese: D05AX52
English: Quality Module
Maltese: Modulu tal-Kwalità
English: Rebound effect - included in section 4.4
Maltese: Effett rebound - inkluż f'sezzjoni 4.4
English: The manufacturer is:
Maltese: Test propost:
English: These studies were MCB 9802 INT and MCB 9904 INT.
Maltese: Dawn l-istudji kienu MCB 9802 INT u MCB 9904
English: Calcipotriol is a vitamin D analogue.
Maltese: Calcipotriol huwa analogu tal-vitamina D.
English: Excipient: 160 micrograms butylated hydroxytoluene/g gel For a full list of excipients, see section 6.1.
Maltese: Sustanza mhux attiva: 160 mikrogramma ta' butylated hydroxytoluene/g ġel Għal-lista kompleta ta' sustanzi mhux attivi, ara Sezzjoni 6.1.
English: Industriparken 55 DK-2750 Ballerup Denmark
Maltese: DK-2750 Ballerup Id-Danimarka
English: Very common ≥1/10 Common
Maltese: Komuni ħafna ≥1/10 Komuni
English: Paraffin, liquid
Maltese: Paraffin, likwidu
English: Section 4.3- Contraindications
Maltese: Sezzjoni 4.3 - Kontra-indikazzjonijiet
English: Daivobet ointment is a combination product which contains the vitamin D analogue, calcipotriol monohydrate and betamethasone dipropionate.
Maltese: Daivobet ointment huwa prodott ta' kombinazzjoni li fih l-analogu tal-vitamina D, calcipotriol monohydrate u betamethasone dipropionate.
English: Calcipotriol and betamethasone.
Maltese: Calcipotriol u betamethasone.
English: Mean percentage reduction in PASI (SD)
Maltese: Tnaqqis fil-medja ta' perċentwali f'PASI (SD)
English: ≥1/100 to <1/10
Maltese: (≥1/100 sa <1/10)
English: Local adverse reactions
Maltese: Reazzjonijiet avversi lokali
English: The following terminologies have been used in order to classify the frequencies of adverse reactions:
Maltese: It-terminoloġiji li ġejjin intużaw sabiex jiġu kklassifikati l-frekwenzi ta' reazzjonijiet avversi:
English: The statement “children and adolescents below the age of 18 years” has been simplified to “children below the age of 18 years”.
Maltese: Id-dikjarazzjoni “tfal u adolexxenti taħt l-età ta' 18-il sena” ġiet issimplifikata għal “tfal taħt l-età ta' 18-il sena”.
English: Daivobet gel (n=1,108)
Maltese: Daivobet ġel (n=1,108)
English: Betamethasone (as dipropionate)
Maltese: Betamethasone (bħala dipropionate)
English: Pack sizes: 15, 30, 60 and 2 x 60 g.
Maltese: Daqsijiet tal-pakkett: 15, 30, 60 u 2 x 60 g.
English: Pharmagan, d.o.o.
Maltese: Is-Slovenja Pharmagan, d.o.o. Vodopivceva 9
English: Effects on calcium metabolism
Maltese: Effetti fuq il-metaboliżmu tal-calcium
English: Daivobet gel (n=126)
Maltese: Daivobet ġel (n=126)
English: ≥1/1,000 to <1/100
Maltese: (≥1/1,000 sa <1/100)
English: Not known frequency - Rebound effect: A worsening of symptoms/psoriasis after ended treatment.
Maltese: Frekwenza mhux magħrufa - Effett rebound: Aggravament tas-sintomi/psorjasi wara t-tmiem tal-kura.
English: Betamethasone is metabolised especially in the liver, but also in the kidneys to glucuronide and sulphate esters.
Maltese: Betamethasone jiġi metabolizzat speċjalment fil-fwied, iżda anki fil-kliewi għal glucuronide u sulphate esters.
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara Sezzjoni 6.1.
English: Daivonex Scalp solution (n=105)
Maltese: Daivonex Soluzzjoni għall-ġilda tarras (n=105)
English: Daivobet gel (n=207)
Maltese: Daivobet ġel (n=207)
English: Carton text:
Maltese: Kaxxa tal-kartun:
English: Daivobet ointment in tubes of 15 g, 30 g, 60 g, 100 g or 120 g
Maltese: Daivobet ingwent fi stoċċijiet ta' 15 g, 30 g, 60 g, 100 g jew 120 g
English: A borderline decrease in cortisol response at 30 minutes post ACTH challenge was seen in 5 of 32 patients (15.6 %) after 4 weeks of treatment and in 2 of 11 patients (18.2 %) who continued treatment until 8 weeks.
Maltese: Kien osservat tnaqqis borderline fir-rispons ta' cortisol wara 30 minuta minn challenge ACTH f'5 minn 32 pazjent (15.6%) wara 4 ġimgħat ta' kura, u fi 2 minn 11-il pazjent (18.2%) li komplew il-kura sa 8 ġimgħat.
English: Common side effects (affect less than 1 in 10 people) - Itching - Rash - Burning sensation.
Maltese: Effetti sekondarji komuni (jaffettwaw inqas minn persuna 1 minn kull 10) - Ħakk - Raxx - Sensazzjoni ta' ħruq.
English: Paraffin, liquid, polyoxypropylene-15 stearyl ether, hydrogenated castor oil, butylhydroxytoluene (E321), all-rac-α-tocopherol.
Maltese: Paraffin, likwidu, polyoxypropylene-15 stearyl ether, hydrogenated castor oil, butylhydroxytoluene (E321), all-rac-α-tocopherol.
English: Pack sizes: 15 g
Maltese: Daqsijiet tal-pakketti: 15 g
English: Adverse events of concern possibly related to long-term corticosteroid use (e.g. skin atrophy, folliculitis, depigmentation, furuncle and purpura) were reported by 4.8 % of the patients in the Daivobet ointment group, 2.8 % in the Daivobet ointment/Daivonex alternating group and 2.9 % in the Daivonex group.
Maltese: Avvenimenti avversi ta' tħassib possibilment relatati mal-użu talkortikosterojd fit-tul (eż. atrofija tal-ġilda, qoxra, depigmentazzjoni, furuncle u purpura) ġew irrapportati minn 4.8 % tal-pazjenti fil-grupp ta' Daivobet ingwent, 2.8 % fil-grupp alternanti ta' Daivobet ingwent/Daivonex u 2.9 % fil-grupp Daivonex.
English: PHARMACEUTICAL FORM AND CONTENTS Ointment
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: United Kingdom LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
Maltese: Ir-Renju Unit LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
English: The MAH proposed to delete this sentence but the CHMP considered useful to include the information in the harmonised SPC.
Maltese: IL-MAH ippropona li jħassar din is-sentenza iżda s-CHMP ikkunsidra li jkun utli li l-informazzjoni tkun inkluża fl-SPC armonizzat.
English: Adverse events possibly related to long-term use of corticosteroids on the scalp, were identified by an independent, blinded panel of dermatologists.
Maltese: Avvenimenti avversi li kienu possibbilment marbuta mal-użu fit-tul ta' kortikosterojdi fuq il-ġilda tar-ras, kienu identifikati minn panel indipendenti u blinded ta' dermatologi.
English: The efficacy and safety of Daivobet ointment has been investigated for periods longer than 4 weeks in study MCB 0102 INT.
Maltese: L-effikaċja u s-sigurtà ta' Daivobet ġew investigati għal perjodi itwal minn 4 ġimgħat fl-istudju MCB 0102 INT.
English: week 8
Maltese: ġimgħa 8
English: Finally, the possibility of more frequent systemic effects “under occlusion” was not mentioned.
Maltese: Fl-aħħarnett, il-possibilità ta' aktar effetti sistemiċi frekwenti “taħt okklużjoni” ma ssemmietx.
English: In all cases, the serum cortisol levels were normal at 60 minutes post ACTH challenge.
Maltese: Fil-każijiet kollha, il-livelli tas-serum cortisol kienu normali wara 60 minuta wara l-isfida ACTH.
English: Daivobet contains calcipotriol and betamethasone.
Maltese: Daivobet ingwent fih calcipotriol u betamethasone.
English: LEO Pharmaceutical Products Ltd. A/S
Maltese: LEO Pharmaceutical Products Ltd.
English: Studies of corticosteroids in animals have shown reproductive toxicity (cleft palate, skeletal malformations).
Maltese: Studji ta' kortikosterojdi fuq l-annimali wrew tossiċità riproduttiva (difetti ta' qsim fil-ħalq, malformazzjonijiet skeletriċi).
English: Following systemic exposure, both active ingredients - calcipotriol and betamethasone dipropionateare rapidly and extensively metabolised.
Maltese: Wara espożizzjoni sistemika, iż-żewġ ingredjenti attivi - calcipotriol u betamethasone dipropionatehuma maetabolizzati b'mod rapidu u estensiv.
English: Pack sizes: 15, 30, 60, 100 and 120 g.
Maltese: Daqsijiet tal-pakkett: 15, 30, 60 u 120 x 60 g.
English: PHARMACEUTICAL FORM Ointment.
Maltese: GĦAMLA FARMAĊEWTIKA Ingwent.
English: INFORMATION IN BRAILLE Carton for 3 g pack size: [To be completed nationally] Daivobet ointment
Maltese: INFORMAZZJONI BIL-BRAILLE Kaxxa tal-kartun għad-daqs tal-pakkett ta' 3 g: [Biex timtela mill-pajjiż partikolari] Daivobet ingwent
English: Adverse reactions to excipients
Maltese: Reazzjonijiet avversi għal sustanzi mhux attivi
English: The MAH agreed, however, that this is not an absolute contraindication and proposed to move it to section 4.4.
Maltese: Madankollu, il-MAH qabel li din mhijiex kontraindikazzjoni assoluta u ippropona li jpoġġiha f'Sezzjoni 4.4.
English: Statistically significantly less effective than Daivobet gel (P<0.05)
Maltese: Statistikament sinifikanti inqas effettiv minn Daivobet ġel (P<0.05)
English: 100 g 120 g
Maltese: 120 g
English: Adverse drug reactions were reported by 21.7 % of the patients in the Daivobet ointment group, 29.6 % in the Daivobet ointment/Daivonex alternating group and 37.9 % in the Daivonex group.
Maltese: Reazzjonijiet avversi relatati malmediċina ġew irrapportati minn 21.7 % tal-pazjenti fil-grupp ta' Daivobet ingwent, 29.6 % fil-grupp alternanti ta' Daivobet ingwent/Daivonex u 37.9 % fil-grupp ta' Daivonex.
English: Plasma elimination half-life after intravenous application is 5-6 hours.
Maltese: Il-half-life taleliminazzjoni mill-plażma wara l-għoti ġol-vini hi ta' 5-6 sigħat.
English: In a study in patients with both extensive scalp and extensive body psoriasis using a combination of high doses of Daivobet gel (scalp application) and high doses of Daivobet ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment (see section 5.1).
Maltese: Fi studju f'pazjenti li jkollhom kemm psorjasi estensiva fil-ġilda tar-ras kif ukoll psorjasi estensiva talġisem, l-użu ta' kumbinazzjoni ta' dożi għolja ta' Daivobet ġel (applikazzjoni fuq il-ġilda tar-ras) u dożi għolja ta' Daivobet ingwent (applikazzjoni fuq il-ġisem), 5 minn 32 pazjent urew tnaqqis borderline firrispons ta' cortisol għal challenge ta' ormon adrenokortikotropiku (ACTH) wara 4 ġimgħat ta' kura (ara sezzjoni 5.1).
English: 1 Statistically significantly less effective than Daivobet gel (P<0.05)
Maltese: 1 Statistikament sinifikanti inqas effettiv minn Daivobet ġel (P<0.05)
English: The text proposed by the MAH gave the clinician more specific information on the available pharmacokinetic data.
Maltese: It-test propost millMAH ta aktar informazzjoni speċifika lit-tabib dwar id-dejta farmakokinetika disponibbli.
English: In vitro data suggest that calcipotriol induces differentiation and suppresses proliferation of keratinocytes.
Maltese: Dejta in vitro tissuġġerixxi li calcipotriol jikkaġuna differenzazzjoni u jrażżan il-proliferazzjoni ta' keratinocytes.
English: These restrictions were introduced to avoid excessive exposure to calcipotriol and the possibility of vitamin D related adverse events (e.g. hypercalcaemia).
Maltese: Dawn ir-restrizzjonijiet ġew introdotti biex tiġi evitata lespożizzjoni eċċessiva għal calcipotriol u l-possibilità ta' avvenimenti avversi relatati mal-vitamina D (eż. iperkalċimija).
English: Other antipsoriatics for topical use, Calcipotriol, combinations.
Maltese: Mediċini oħra kontra l-psorjasi għal użu topiku, Calcipotriol, kombinazzjonijiet.
English: Three MSs SPC stated: “there is experience with repeated courses of Daivobet up to 52 weeks” which was supported by study MCB 0102 INT.
Maltese: Tliet SPCs tal-SM iddikjaraw: “hemm esperjenza b'korsijiet ripetuti ta' Daivobet sa 52 ġimgħa” li kienet appoġġjata bl-istudju MCB 0102 INT.
English: In study MCB 0102 INT there was a trend towards greater efficacy and a lower incidence of adverse events reported in patients who remained on Daivobet ointment applied as required compared with patients who switched to other treatments.
Maltese: Fl-istudju MCB 0102 INT kien hemm tendenza lejn iktar effikaċja u inqas inċidenza ta' avvenimenti avversi rrapportati f'pazjenti li baqgħu fuq Daivobet ingwent applikat kif meħtieġ meta mqabbel ma' pazjenti li qalbu għal trattamenti oħrajn.
English: Studies in animals with glucocorticoids have shown reproductive toxicity (see section 5.3), but a number of epidemiological studies have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy.
Maltese: Studji dwar glukokortikojdi flannimali wrew tossiċità riproduttiva (ara sezzjoni 5.3), iżda numru ta' studji epidemjoloġiċi ma żvelaw lebda anomaliji konġenitali fost trabi li twieldu lil nisa kkurati b'kortikosterojdi matul it-tqala.
English: The CHMP agreed to this proposal.
Maltese: Is-CHMP qabel ma' din il-proposta.
English: Secondary infection is a documented local adverse effect of treatment with topical corticosteroids.
Maltese: L-infezzjoni sekondarja hija effett avvers lokali dokumentat tattrattament b'kortikosterojdi topiċi.
English: Adrenocortical suppression, cataract, infections, impact on the metabolic control of diabetes mellitus and increase of intra-ocular pressure can occur, especially after long term treatment.
Maltese: Trażżin adrenokortikali, katarretti, infezzjonijiet, impatt fuq il-kontroll metaboliku ta' dijabete mellitus u żieda tal-pressjoni intraokulari jistgħu jseħħu, speċjalment wara kura fit-tul.
English: High-density polyethylene bottles with low-density polyethylene nozzle and a high-density polyethylene screw cap.
Maltese: Fliexken tal-polyethylene ta' densità għolja, b'nozzle tal-polyethylene ta' densità baxxa u b'għatu bilkamini tal-polyethylene ta' densità għolja.
English: LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
Maltese: A/S (LEO Pharma A/S) Industriparken 55
English: Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia.
Maltese: Reazzjonijiet lokali jistgħu jseħħu wara l-użu topiku, speċjalment matul applikazzjoni fit-tul, li jinkludu atrofija tal-ġilda, telangiectasia, striae, follikulite, ipertrikosi, dermatite periorali, dermatite allergika talkuntatt, depigmentazzjoni u colloid milia.
English: Subjects with unstable psoriasis (erythrodermic, exfoliative or pustular psoriasis) were excluded.
Maltese: Suġġetti bi psorijażi instabbli (psorijażi eritrodermika, bil-qxur jew bil-ponot) ġew esklużi.
English: In conclusion, the CHMP endorsed the following wording under this section: Daivobet ointment SPC: “Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy in adults”.
Maltese: SPC ta' Daivobet ingwent: “Trattament topiku tal-psorijażi vulgaris bi plakka stabbli soġġetta għal terapija topika fl-adulti”.
English: The adverse drug reactions that were reported by more than 2 % of the patients in the Daivobet ointment group were pruritus (5.8 %) and psoriasis (5.3 %).
Maltese: Ir-reazzjonijiet avversi tal-mediċina li kienu rrappurtati minn iktar minn 2% tal-pazjenti fil-grupp ta' Daivobet ingwent kienu ħakk (5.8%) u psorjasi (5.3%).
English: The systemic exposure to calcipotriol and betamethasone dipropionate from topically applied Daivobet gel is comparable to Daivobet ointment in rats and minipigs.
Maltese: L-espożizzjoni sistemika għal calcipotriol u betamethasone dipropionate minn Daivobet ġel applikat b'mod topiku, hi komparabbli għal Daivobet ingwent fil-firien u fil-minipigs.
English: In one SPC the undesirable effects were not tabulated by MedDRA SOC (System Organ Class) as recommended in the EU SPC guideline.
Maltese: F'SPC minnhom, l-effetti mhux mixtieqa ma ġewx ippreżentati mill-MedDRA SOC (Sistema ta' Klassifika tal-Organi) kif irrakkomandat fil-linja gwida tal-SPC tal-UE.
English: With long-term use there is an increased risk of local and systemic corticosteroid adverse reactions.
Maltese: Bl-użu fit-tul hemm żieda fir-riskju ta' reazzjonijiet avversi lokali u sistemiċi minħabba l-kortikosterojdi.
English: The study MBL 0404 FR, conducted for the development of Daivobet gel, investigated the adrenal response to adrenocorticotropic hormone (ACTH) and its results were included in the approved Daivobet gel SPC.
Maltese: FR, li sar għall-iżvilupp ta' Daivobet ġel, investiga r-rispons adrenali għall-ormon adrenokortikotropiku (ACTH) u r-riżultati tiegħu ġew inklużi fl-SPC approvat ta' Daivobet ġel.
English: When treating psoriasis there may be a risk of generalised pustular psoriasis.
Maltese: Meta tikkura l-psorjasi, jista' jkun hemm riskju ta' psorjasi bilponot ġeneralizzata.
English: Section 5.1 - Pharmacodynamic properties
Maltese: Sezzjoni 5.1 - Tagħrif farmakodinamiku
English: Rare (affects less than 1 in 1,000 people) - Pustular psoriasis may occur (a red area with yellowish pustules usually on the hands or feet).
Maltese: Rari (jaffettwaw inqas minn persuna 1 minn kull 1,000) - Psorjasi bil-ponot (żona ħamra b'ponot sofor, normalment fuq l-idejn jew fuq is-saqajn).
English: Uncommon local adverse reactions (such as eye irritation or irritation of facial skin) were observed, when the medicinal product was accidentally administered in the area of face, or accidentally to the eyes or conjunctives (see sections 4.8 and 5.1).
Maltese: Reazzjonijiet avversi lokali mhux komuni (bħal irritazzjoni fl-għajnejn jew irritazzjoni fil-wiċċ il-ġilda) kienu osservati, meta l-mediċina ndilket aċċidentalment fiż-żona tal-wiċċ, jew aċċidentalment fl-għajnejn jew konġuntiva (ara sezzjonijiet 4.8 u 5.1).
English: Daivobet ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults.
Maltese: Daivobet ingwent jintuża fuq il-ġilda biex jikkura psorjasi tal-plakka (psoriasis vulgaris) f'persuni adulti.
English: Daivobet gel contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Maltese: Daivobet fih butylated hydroxytoluene (E321), li jista' jikkawża reazzjonijiet lokali tal-ġilda (eż. dermatite tal-kuntatt), jew irritazzjoni fl-għajnejn u fil-membrani mukużi.
English: The study MBL 0404 FR investigated also the systemic effects of the combined use of Daivobet gel (used on the scalp) and Daivobet ointment (used on the body) in patients with psoriasis vulgaris on these areas.
Maltese: FR investiga wkoll l-effetti sistemiċi tal-użu kombinat ta' Daivobet ġel (użat fuq il-qurriegħa) u Daivobet ingwent (użat fuq il-ġisem) fuq pazjenti bi psorijażi vulgaris fuq dawn il-partijiet.
English: The order of the information has been changed and reworded so that is in accordance with the information in the SPC for Daivobet gel: the word “strong” has been deleted from the definition of betamethasone dipropionate that is classified as a potent group III steroid.
Maltese: L-ordni tal-informazzjoni tbiddlet u ġiet ifformulata mill-ġdid biex tkun f'konformità mal-informazzjoni fl-SPC għal Daivobet ġel: il-kelma “qawwi” tneħħiet mid-definizzjoni ta' betamethasone dipropionate li huwa ikklassifikat bħala sterojde qawwi tal-grupp III.