FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of once daily use of Daivobet gel was investigated in two randomised, double-blind, 8week clinical studies including a total of more than 2,900 patients with scalp psoriasis of at least mild severity according to the Investigator's Global Assessment of disease severity (IGA).
Maltese: L-effikaċja tal-użu darba kuljum ta' Daivobet ġel kienet investigata f'żewġ studji kliniċi double-blind li fihom il-parteċipanti ntgħażlu b'mod każwali, li damu 8 ġimgħat u li kienu jinkludu total ta' iktar minn 2,900 pazjent bi psorjasi fil-ġilda tar-ras ta' mill-inqas severità ħafifa skont l-Evalwazzjoni Globali talInvestigatur (IGA - Investigator's Global Assessment) tas-severità tal-marda.
English: Exacerbation of psoriasis Skin pain or irritation Dermatitis
Maltese: Aggravament ta' psorjasi Uġigħ jew irritazzjoni fil-ġilda Dermatite
English: However, when the treatment is stopped, the levels return to normal.
Maltese: Madankollu, meta l-kura titwaqqaf, il-livelli jerġgħu lura għan-normal.
English: Clinical studies with radiolabelled ointment indicate that the systemic absorption of calcipotriol and betamethasone from Daivobet ointment formulation is less than 1 % of the dose (2.5 g) when applied to normal skin (625 cm2) for 12 hours.
Maltese: Studji kliniċi b'ingwent radjutikkettat jindikaw li l-assorbiment sistemiku ta' calcipotriol u betamethasone minn Daivobet ingwent hu ta' inqas minn 1% tad-doża (2.5 g) meta jiġi applikat fuq ġilda normali (625 ċm2) għal 12-il siegħa.
English: Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial oedema.
Maltese: Reazzjonijiet avversi jinkludu reazzjonijiet fis-sit tal-applikazzjoni, ħakk, irritazzjoni tal-ġilda, sensazzjoni ta' ħruq u tingiż, ġilda xotta, eritema, raxx, dermatite, ekżema, psorjasi aggravata, sensittività għad-dawl u reazzjonijiet ta' sensittività eċċessiva li jinkludu każijiet rari ħafna ta' anġjoedema u edema tal-wiċċ.
English: Pustular psoriasis
Maltese: Popolazzjoni pedjatrika
English: Ointment
Maltese: Follikulite
English: The other ingredients are: - paraffin, liquid - polyoxypropylene-15 stearyl ether - castor oil, hydrogenated - butylhydroxytoluene (E321) - all-rac-α-tocopherol.
Maltese: Is-sustanzi l-oħra huma: - paraffin, likwidu - polyoxypropylene-15 stearyl ether - castor oil, hydrogenated - butylhydroxytoluene (E321) - all-rac-α-tocopherol
English: The percentage change in Psoriasis Severity and Area index (PASI) from baseline to week 4 and week 8 were secondary response criteria.
Maltese: Il-bidla fil-perċentwali fl-Indiċi tas-Severità tal-Psorjasi u taż-Żona (PASI - Psoriasis Severity and Area index) mil-linja bażi għal ġimgħa 4 u ġimgħa 8 kienu kriterji rispons sekondarju.
English: Paediatric population
Maltese: Popolazzjonijiet pedjatrika
English: The treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid (see section 4.8).
Maltese: Il-kura għandha titwaqqaf f'każ ta' reazzjonijiet avversi assoċjati mal-użu ta' kortikosterojdi fit-tul (ara sezzjoni 4.8).
English: The text “impact on the metabolic control of diabetes mellitus” has also been agreed by the CHMP as undesirable effects of betamethasone dipropionate accordingly to the cross reference from section 4.4.
Maltese: Is-CHMP qabel fuq it-test “impatt fuq il-kontroll metaboliku tad-dijabete mellitus” bħala effetti mhux mixtieqa ta' betamethasone dipropionate skont il-kross-referenza minn Sezzjoni 4.4.
English: The trial programme for Daivobet ointment has so far included more than 2,500 patients and has shown that approximately 10 % of patients can be expected to experience a non-serious undesirable effect.
Maltese: Il-programm ta' provi għal Daivobet ingwent s'issa inkluda iktar minn 2,500 pazjent u wera li madwar 10% tal-pazjenti jistgħu jkunu mistennija li jkollhom effett mhux mixtieq mhux serju.
English: The MAH proposed as the harmonised text to the ointment the following wording: “Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy”.
Maltese: Il-MAH ippropona l-formolazzjoni tal-kliem li ġejja bħala t-test armonizzat għall-ingwent: “Kura topika tal-psorijażi vulgaris bi plakka stabbli soġġetta għal terapija topika”.
English: Due to the content of calcipotriol Daivobet ointment is contra-indicated in patients with known disorders of calcium metabolism.
Maltese: Minħabba l-kontenut ta' calcipotriol, Daivobet ingwent hu kontraindikat f'pazjenti b'disturbi magħrufa fil-metaboliżmu tal-calcium.
English: Proposed text: Clinical studies with radiolabelled ointment indicate that the systemic absorption of calcipotriol and betamethasone from Daivobet ointment formulation is less than 1% of the dose (2.5 g) when applied to normal skin (625 cm²) for 12 hours.
Maltese: Studji kliniċi b'ingwent radotikkettjat jindikaw li l-assorbiment sistemiku ta' calcipotriol u betamethasone mill-formulazzjoni ta' Daivobet ingwent huwa inqas minn 1% tad-doża (2.5g) meta applikata fuq ġilda normali (625 cm²) għal 12-il siegħa.
English: Daivobet gel in bottles of 15 g, 30 g and 60 g
Maltese: Daivobet ġel fi fliexken ta' 15 g, 30 g u 60 g
English: The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively:
Maltese: Ir-reazzjonijiet avversi li ġejjin huma kkunsidrati li huma marbuta mal-klassijiet farmakoloġiċi ta' calcipotriol u betamethasone, rispettivament:
English: In one MS SPC there was the contraindication in patients with disorders of calcium metabolism.
Maltese: Fl-SPC ta' SM wieħed kien hemm il-kontra-indikazzjoni f'pazjenti b'disturbi fil-metaboliżmu tal-kalċju.
English: There was no difference in the percentages of patients experiencing such adverse events between the treatment groups (2.6 % in the Daivobet gel group and 3.0 % in the calcipotriol group; P=0.73).
Maltese: Ma kien hemm l-ebda differenza fil-perċentwali ta' pazjenti li kien qed ikollhom avvenimenti avversi bejn il-gruppi tal-kura (2.6% fil-grupp ta' Daivobet ġel u 3.0% filgrupp ta' calcipotriol; P=0.73). Ma ġew irrappurtati l-ebda każijiet ta' atrofija tal-ġilda.
English: When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30 % (see section 4.4).
Maltese: L-erja tassuperfiċje tal-ġisem ikkurata bi prodotti mediċinali li fihom calcipotriol m'għandhiex taqbeż 30% (ara sezzjoni 4.4).
English: The main route of excretion of calcipotriol is via faeces (rats and minipigs) and for betamethasone dipropionate it is via urine (rats and mice).
Maltese: Ir-rotta ewlenija ta' tneħħija ta' calcipotriol hi permezz tal-ippurgar (firien u minipigs) u għal betamethasone dipropionate hi permezz tal-awrina (firien u ġrieden).
English: Section 4.1 - Therapeutic Indications
Maltese: Sezzjoni 4.1 - Indikazzjonijiet Terapewtiċi
English: Folliculitis
Maltese: FARMAĊEWTIKU
English: Daivobet gel is a different formulation which contains the same active substances in the same concentrations as in Daivobet ointment.
Maltese: Daivobet gel, huwa formulazzjoni differenti li fiha l-istess sustanzi attivi fl-istess konċentrazzjonijiet bħal f'Daivobet ingwent.
English: DAIVOBET GEL
Maltese: DAIVOBET ĠEL
English: The other ingredients are: - liquid paraffin - all-rac-α-tocopherol - polyoxypropylene-15-stearyl ether - white soft paraffin.
Maltese: Liquid paraffin, all-rac-α-tocopherol, polyoxypropylene-15-stearyl ether, white soft paraffin
English: - Thinning of the skin - Appearance of surface blood vessels or stretch marks - Changes in hair growth - Red rash around the mouth (perioral dermatitis) - Skin rash with inflammation or swelling (allergic contact dermatitis) - Shiny brown gel-filled bumps (colloid milia) - Lightening of skin colour (depigmentation).
Maltese: - Raxx tal-ġilda b'infjammazzjoni jew nefħa (dermatite allergika tal-kuntatt) - Tikek żgħar bojod (colloid milia) - Depigmentazzjoni (il-kulur tal-ġilda jiċċara).
English: Due to the content of corticosteroid, Daivobet gel is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds, perianal and genital pruritus.
Maltese: Minħabba l-kontenut tal-kortikosterojd, Daivobet ġel hu kontraindikat fil-kundizzjonijiet li ġejjin: Leżjonijiet virali (eż. herpes jew ġidri r-riħ) tal-ġilda, infezzjonijiet fungali jew batterjali tal-ġilda, infezzjonijiet parasitiċi, sintomi tal-ġilda fir-rigward ta' tuberkulosi jew sifilide, dermatite periorali, ġilda atrofika, striae atrophicae, fraġilità tal-vini tal-ġilda, iktijosi, akne vulgaris, akne rosaċea, rosaċea, ulċeri, feriti, ħakk perianali u ġenitali.
English: This proposed text is identical to the current MRP SPC except for the following: As outlined in section 4.4, information about the pharmacokinetic results from a clinical study, MBL 0404 FR has been included as follows: “Calcipotriol and betamethasone dipropionate were below the lower limit of quantification in all blood samples of 34 patients treated for 4 or 8 weeks with both Daivobet gel and Daivobet ointment for extensive psoriasis involving the body and scalp.
Maltese: FR ġiet inkluża kif ġej: “Calcipotriol u betamethasone dipropionate kienu taħt il-limitu ta' kwantifikazzjoni fil-kampjuni tad-demm kollha ta' 34 pazjent trattati għal 4 jew 8 ġimgħat kemm b'Daivobet ġel kif ukoll b'Daivobet ingwent għal psorijażi estensiva li tinvolvi l-ġisem u l-qorriegħa.
English: As outlined in section 4.4, information about results from a clinical study, MBL 0404 FR, where adrenal response to adrenocorticotropic hormone (ACTH) was determined, has been included.
Maltese: Kif sottolinejat fis-Sezzjoni 4.4, l-informazzjoni dwar ir-riżultati farmakokinetiċi minn studju kliniku, MBL 0404
English: In local tolerability studies in rabbits, Daivobet gel caused mild to moderate skin irritation and a slight transient irritation of the eye.
Maltese: Fi studji dwar it-tollerabilità lokali fil-fniek, Daivobet ġel ikkawża irritazzjoni tal-ġilda minn ħafifa sa moderata u irritazzjoni temporanja u ħafifa fl-għajnejn.
English: The statement “After this period repeated treatment with Daivobet ointment can be initiated under medical supervision” was considered unclear by the CHMP as Daivobet treatment is presumably initiated by a doctor and treatment is presumably monitored.
Maltese: Id-dikjarazzjoni “Wara dan il-perjodu, it-trattament ripetut b'Daivobet ingwent jista' jinbeda taħt superviżjoni medika” tqieset bħala mhux ċara mis-CHMP billi t-trattament b'Daivobet huwa preżumibbilment mibdi minn tabib u t-trattament huwa preżumibbilment immonitorjat.
English: The MAH proposed the following amendment in section 5.1: “A safety study in 634 psoriasis patients has investigated repeated courses of Daivobet ointment used once daily as required, either alone or alternating with Daivonex for up to 52 weeks, compared with Daivonex used alone for 48 weeks after an initial course of Daivobet ointment.
Maltese: Il-MAH ippropona l-emenda li ġejja fis-Sezzjoni 5.1: “Studju dwar is-sigurtà f'634 pazjent bil-psorijażi investiga korsijiet ripetuti ta' Daivobet ingwent użat darba kuljum kif meħtieġ, jew waħdu jew alternanti ma' Daivonex sa 52 ġimgħa, imqabbel ma' Daivonex użat waħdu għal 48 ġimgħa wara kors inizjali ta' Daivobet ingwent.
English: Considering that hypercalcaemia, resulting from extensive exposure to calcipotriol, has been reported in a few cases in the literature, the CHMP endorsed the MAH proposal and added a cross reference to section 4.2.
Maltese: Meta wieħed iqis li l-iperkalċimija, li tirriżulta minn espożizzjoni estensiva għal calcipotriol, ġiet irrapportata fi ftit każijiet fil-letteratura, is-CHMP awtorizza l-proposta tal-MAH u żied referenza għal Sezzjoni 4.2.
English: Skin and subcutaneous tissue disorders Common
Maltese: Infezzjonijiet konkomittanti tal-ġilda
English: Pharmacotherapeutic group: Antipsoriatics.
Maltese: Mediċini kontra l-psorjasi.
English: The CHMP agreed with the MAH proposal and with the addition of greater details regarding situations where steroids should not be used and endorsed the following: “Due to the content of corticosteroid, Daivobet ointment is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds, perianal and genital pruritus”.
Maltese: Is-CHMP qabel mal-proposta tal-MAH u biż-żieda ta' aktar dettalji rigward is-sitwazzjonijiet fejn l-isterojdi m'għandhomx jintużaw u awtorizza dan li ġej: “Minħabba l-kontenut talkortikosterojde, Daivobet ingwent huwa kontra-indikat fil-kundizzjonijiet li ġejjin: Leżjonijiet virali (eż. ħerpes jew variċella) tal-ġilda, infezzjonijiet fungali jew batterjali tal-ġilda, infezzjonijiet parassitiċi, manifestazzjonijiet tal-ġilda fir-rigward tat-tuberkulożi jew sifilide, dermatite perjorali, ġilda atrofika, striji atrofiċi, fraġilità tal-vini tal-ġilda, iktijożi, akne vulgaris, akne rosacea, rosacea, ulċeri, feriti, ħakk perjanali u ħakk fil-ġenitali”.
English: Absorption through damaged skin is approx. 24 %.
Maltese: L-assorbiment minn ġo ġilda affettwata hu ta' madwar 24%.
English: There is experience with repeated courses of Daivobet up to 52 weeks.
Maltese: Hemm esperjenza b'korsijiet ripetuti ta' Daivobet sa 52 ġimgħa.
English: The MAH believed useful the insertion of the following: “It has been reported that due to misuse one patient with extensive erythrodermic psoriasis treated with 240 g of Daivobet ointment weekly (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed Cushing's syndrome and pustular psoriasis after abruptly stopping treatment”.
Maltese: Il-MAH ra utli li jiddaħħal dan li ġej: “Ġie rrapportat li minħabba l-użu ħażin, pazjent wieħed bi psorijażi eritrodermika estensiva ittrattat b'240 g ta' Daivobet ingwent fil-ġimgħa (li tikkorrispondi għal doża ta' kuljum ta' madwar 34 g) għal 5 xhur (id-doża massima rakkomandata hija ta' 15 g kuljum) żviluppa s-sindromu ta' Cushing u psorijażi bil-ponot wara li waqqaf it-trattament f'daqqa”.
English: Calcipotriol and betamethasone dipropionate were below the lower limit of quantification in all blood samples of 34 patients treated for 4 or 8 weeks with both Daivobet gel and Daivobet ointment for extensive psoriasis involving the body and scalp.
Maltese: Calcipotriol u betamethasone dipropionate kienu taħt il-limitu t'isfel tal-kwantifikazzjoni fil-kampjuni kollha tad-demm ta' 34 pazjent ikkurati għal 4 jew 8 ġimgħat kemm b'Daivobet ġel kif ukoll b'Daivobet ingwent għal psorjasi estensiva li tinvolvi l-ġisem u l-ġilda tar-ras.
English: As Daivobet contains a strong steroid do NOT use it on skin affected by - infections caused by viruses (e.g. cold sores or chicken pox) - infections caused by a fungus (e.g. athlete's foot or ringworm) - infections caused by bacteria - infections caused by parasites (e.g. scabies) - tuberculosis (TB) or syphilis - perioral dermatitis (red rash around the mouth) - thin skin, easily damaged veins, stretch marks - ichthyosis (dry skin with fish-like scales) - acne (pimples) - rosacea (severe flushing or redness of the skin on the face) - ulcers or broken skin - itching of the anus (back passage) or genitals (sex organs).
Maltese: Billi Daivobet fih sterojd qawwi, TUŻAHX fuq ġilda li tkun affettwata minn - infezzjonijiet ikkawżati minn viruses (eż. ponot minħabba d-deni jew ġidri r-riħ) - infezzjonijiet ikkawżati minn fungu (eż. fungu li jattakka s-sieq jew ħżieża) - infezzjonijiet ikkawżati minn batterji - infezzjonijiet ikkawżati minn parassiti (eż. ħakk) - tuberkulosi (TB) jew sifilide - dermatite periorali (raxx aħmar madwar il-ħalq) - ġilda rqiqa, vini li faċilment tiġrilhom il-ħsara, sinjali ta' ġbid fil-ġilda - iktijosi (ġilda xotta bi qxur bħal tal-ħut) - akne (ponot)
English: Daivobet ointment in tubes of 3 g
Maltese: Ż-ŻGĦAR EWLENIN, STOĊĊ Daivobet ingwent fi stoċċijiet ta' 3 g
English: This recommendation is based on non-clinical photo(co)carcinogenicity data.
Maltese: Din irrakkomandazzjoni hija bbażata fuq id-dejta tal-foto(ko)karċinoġeniċità mhux klinika.
English: One metabolite of calcipotriol and one metabolite of betamethasone dipropionate were quantifiable in some of the patients.
Maltese: Metabolit wieħed ta' calcipotriol u metabolit wieħed ta' betamethasone dipropionate kienu kwantifikabbli f'uħud mill-pazjenti.
English: One SPC did not include: “Based on data from clinical trials and post market use the common undesirable effects are pruritus, rash and burning sensation of skin.
Maltese: SPC minnhom ma inkludiex: “Skont dejta minn provi kliniċi u mill-użu wara t-tqegħid fis-suq, l-effetti mhux mixtieqa komuni huma l-ħakk, ir-raxx u sensazzjoni ta' ħruq fuq il-ġilda.
English: The text “impact on the metabolic control of diabetes mellitus” has been added to the undesirable effects of betamethasone dipropionate as already stated in section 4.4 of the DCP SPC.
Maltese: It-test “impatt fuq ilkontroll metaboliku tad-dijabete mellitus” ġie miżjud mal-effetti mhux mixtieqa ta' betamethasone dipropionate kif diġà imniżżel f'Sezzjoni 4.4 tal-SPC tad-DCP.
English: It has been reported that due to misuse one patient with extensive erythrodermic psoriasis treated with 240 g of Daivobet ointment weekly (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed Cushing's syndrome and pustular psoriasis after abruptly stopping treatment.
Maltese: Kien irrappurtat li minħabba użu ħażin, pazjent wieħed bi psorjasi eritrodermika estensiva, ikkurat b'240 g ta' Daivobet ingwent fil-ġimgħa (li tikkorrispondi għal doża ta' kuljum ta' madwar 34 g) għal 5 xhur (doża massima rakkomandata 15 g kuljum), żviluppa s-sindrome ta' Cushing u psorjasi bil-ponot wara li waqqaf il-kura f'daqqa.
English: 1 Statistically significantly less effective than Daivobet gel (P<0.001)
Maltese: 1 Statistikament sinifikanti inqas effettiv minn Daivobet ġel (P<0.
English: Very rare Not known (cannot be estimated from the available data)
Maltese: Rari ħafna Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)
English: Special populations
Maltese: F'diversi
English: Pustular rash
Maltese: TAGĦRIF
English: INFORMATION IN BRAILLE [To be completed nationally] Carton text: Daivobet gel.
Maltese: [Biex timtela mill-pajjiż partikolari] Kitba għal fuq il-kaxxa tal-kartun: Daivobet ġel.
English: Topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults”.
Maltese: Trattament topiku talpsorijażi vulgaris bi plakka “mhux fil-qurriegħa” ħafifa għal moderata fl-adulti”.
English: Section 4.2 - Posology and method of administration
Maltese: Sezzjoni 4.6 - Fertilità, tqala u treddigħ
English: The harmonised text proposed by the MAH was in line to the MRP SPC.
Maltese: It-test armonizzat propost mill-MAH kien konformi mal-SPC tal-MRP.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Gramma waħda ta' ġel fiha 50 mikrogramma ta' calcipotriol (bħala monohydrate) u 0.5 mg ta' betamethasone (bħala dipropionate).
English: In some MSs betamethasone dipropionate was described as a “glucocorticoid showing the general characteristics of the corticosteroids”.
Maltese: F'xi SM, betamethasone dipropionate kien deskritt bħala “glukokortikojde li juri l-karatteristiċi ġenerali tal-kortikosterojdi”.
English: The following serious effects have been reported for Daivobet:
Maltese: L-effetti sekondarji serji li ġejjin kienu rrappurtati għal Daivobet:
English: 2 x 60 g (valid for the packaging containing two 60 g bottles)
Maltese: 2 x 60 g (jgħodd għall-ippakkjar li fih żewġ fliexken ta' 60 g)
English: What Daivobet looks like and contents of the pack Daivobet ointment is an off-white to yellow coloured ointment filled in aluminium/epoxyphenol tubes with polyethylene screw cap.
Maltese: Id-Dehra ta' Daivobet u l-kontenuti tal-pakkett Daivobet hu ġel kważi ċar, bla kulur sa ftit abjad jagħti fil-griż, mimli fi fliexken tal-polyethylene ta' densità għolja, b'nozzle tal-polyethylene ta' densità baxxa u b'għatu bil-kamini tal-polyethylene ta' densità għolja.
English: No major updates to the Daivobet gel SPC according to the adoption of Daivobet ointment SPC (MRP) were required.
Maltese: Dan huwa f'konformità mal-SPC approvat mid-DCP għal Daivobet ġel.
English: Daivobet ointment is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Maltese: Daivobet ingwent hu kontraindikat f'pazjenti bi psorjasi eritrodermika, bil-qxur u bil-ponot.
English: Daivobet gel is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Maltese: Is-CHMP ra li l-bidliet proposti huma xierqa u aċċettabbli.
English: Gel.
Maltese: JIS.
English: Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g ointment [See Annex I - To be completed nationally] Calcipotriol/betamethasone
Maltese: Daivobet u ismijiet assoċjati (ara Anness I) 50 mikrogramma/0.5 mg/g ġel [Ara Anness I - Biex timtela mill-pajjiż partikolari] calcipotriol/betamethasone
English: Important information about some of the ingredients of Daivobet Daivobet contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Daivobet 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: Other studies were submitted in support of the efficacy and safety of Daivobet ointment on the body (MCB 9802 INT and MCB 9904 INT), patients in these studies were allowed to use other topical medication on scalp psoriasis.
Maltese: Ġew sottomessi studji oħrajn biex isostnu l-effikaċja u s-sigurtà ta' Daivobet ingwent fuq il-ġisem (MCB 9802 INT u MCB 9904
English: Regarding the contraindication for guttate psoriasis, this has been included in the SPC based on its exclusion from the clinical trial programme as well.
Maltese: Rigward il-kontra-indikazzjonijiet għall-psorijażi guttate, din kienet inkluża fl-SPC minħabba l-esklużjoni tagħha mill-programm ta' prova klinika wkoll.
English: Daivobet ointment for body psoriasis lesions has been used in combination with Daivobet gel for scalp psoriasis lesions, but there is no experience of combination of Daivobet with other topical anti-psoriatic products at the same treatment arrea, other anti-psoriatic medicinal products administered systemically or with phototherapy.
Maltese: F'dawn l-istudji, is-suġġetti kienu meħtieġa li jkollhom “psorijażi vulgaris soġġetta għal terapija b'medikazzjoni topika” u s-suġġetti li kienu jirrikjedu trattament antipsorjatiku sistemiku jew fototerapija ġew esklużi.
English: One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Maltese: Gramma waħda ta' ġel fiha 50 mikrogramma ta' calcipotriol (bħala monohydrate) u 0.5 mg ta' betamethasone (bħala dipropionate).
English: Adrenal response to ACTH was determined by measuring serum cortisol levels in patients with both extensive scalp and body psoriasis, using up to 106 g per week combined Daivobet gel and Daivobet ointment.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont il-Klassi tal-Organi tas-Sistema MedDRA, u r-reazzjonijiet avversi individwali huma elenkati b'dawk irrappurtati li jseħħu b'mod l-aktar frekwenti jidhru l-ewwel.