natgillin/translations-raw huggingface dataset:
The use of Daivobet should be stopped as indicated by your doctor.
Z zdravljenjem z zdravilom Daivobet lahko prenehate v skladu z navodili vašega zdravnika.
Due to the formation of a depot in the skin elimination after dermal application is in order of days.
Ker se skladišči v koži, se po nanosu na kožo odstrani v dnevih.
The MAH proposed as the harmonised text to the ointment the following wording: “Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy”.
Imetnik dovoljenja za promet z zdravilom je kot usklajeno besedilo za mazilo predlagal naslednje besedilo: „Topično zdravljenje stabilne psoriaze vulgaris v plakih, ki se odziva na topično zdravljenje“.
Effects on calcium metabolism
Učinki na presnavljanje kalcija
Keep the bottle in the outer carton in order to protect from light - Discard the bottle with any remaining gel 3 months after first opening.
- Plastenko z morebitnimi ostanki gela zavrzite po 3 mesecih po prvem odprtju.
In one SPC the undesirable effects were not tabulated by MedDRA SOC (System Organ Class) as recommended in the EU SPC guideline.
V enem povzetku glavnih značilnosti zdravila neželeni učinki niso bili tabelirani po standardnem organskem sistemu po MedDRA v skladu s priporočili navodil za povzetke glavnih značilnosti zdravil EU.
The CHMP considered acceptable that in the studies performed to support the gel and ointment formulations, concomitant medication to treat psoriasis of the body and scalp respectively was permitted.
CHMP je menil, da je na podlagi študij, izvedenih v podporo sočasnemu zdravljenju psoriaze telesa in lasišča s formulacijo gela in mazila, to dovoljeno.
HOW TO USE DAIVOBET
KAKO UPORABLJATI ZDRAVILO DAIVOBET
The systemic exposure to calcipotriol and betamethasone dipropionate from topically applied Daivobet gel is comparable to Daivobet ointment in rats and minipigs.
Sistemska absorpcija kalcipotriola in betametazondipropionata iz topikalno apliciranega Daivobet gela je podobna le-tej iz Daivobet mazila, ki so ga uporabljali na podganah in prašičih (minipig).
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).
Pri uporabi zdravil, ki vsebujejo kalcipotriol, maksimalni dnevni odmerek ne sme presegati 15 g. Zdravil, ki vsebujejo kalcipotriol, ne smemo uporabljati na površini, večji od 30 % telesne površine (glejte poglavje 4.4).
When treating psoriasis with topical corticosteroids there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment.
Pri zdravljenju psoriaze s topikalnimi kortikosteroidi obstaja nevarnost nastanka generalizirane pustulozne psoriaze, ob prekinitvi zdravljenja z njimi pa lahko pride do povratnega učinka (rebound effect).
There was no evidence of change of calcium metabolism observed in these patients.
Pri teh bolnikih ni bilo dokaza o spremenjenem presnavljanju kalcija.
Aluminium/epoxyphenol tubes with polyethylene screw cap.
Aluminijasta/epoksifenolna tuba z navojnim pokrovčkom iz polietilena.
Off-white to yellow.
Belkasto do rumeno mazilo.
[See Annex I - To be completed nationally]
[glejte Prilogo I - izpolni država članica]
Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids.
Izogibati se moramo tudi uporabi kortikosteroidov pod okluzivnimi povoji, saj se s tem poveča njihova sistemska absorpcija.
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.
Neželeni učinki vključujejo: reakcije na mestu aplikacije zdravila, pruritus, draženje kože, pekoč in bodeč občutek v koži, suho kožo, eritem, izpuščaj, dermatitis, ekcem, poslabšanje psoriaze, fotosenzitivnost in preobčutljivostne reakcije, vključno z zelo redkimi primeri angiodema in obraznega edema.
This will avoid accidentally spreading the ointment to other parts of your body
S tem boste preprečili nehoteni prenos mazila na ostale dele telesa (predvsem na obraz,
The adverse reactions are listed by MedDRA System Organ Class, and the individual adverse reactions are listed starting with the most frequently reported.
Neželeni učinki so razvrščeni po podatkovni bazi MedDRA glede na organske sisteme, posamezni neželeni učinki pa so razvrščeni po padajoči pogostnosti.
Skin and subcutaneous tissue disorders Common
Bolezni kože in podkožja Pogosti pruritus
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.
V skladu z navedbo v poglavju 4.4 so bile vključene informacije o farmakokinetičnih rezultatih iz klinične študije MBL 0404 FR: „Kalcipotriol in betametazon dipropionat sta bila pod spodnjo mejo kvantifikacije pri vseh krvnih vzorcih 34 bolnikov, zdravljenih od štiri do osem tednov z zdravilom Daivobet gel in Daivobet mazilo zaradi obsežne psoriaze tako na telesu kot lasišču.
Unevaluated uses There is no experience for the use of Daivobet ointment in guttate psoriasis.
Nepreskušeni načini uporabe Izkušenj o uporabi Daivobet mazila pri gutatni psoriazi ni.
The patient should be instructed not to use Daivobet on the breast when breast-feeding.
Bolnico je potrebno poučiti, da v času dojenja ne uporablja Daivobet mazila na prsih.
Photo(co)carcinogenicity studies in mice suggest that calcipotriol may enhance the effect of UVR to induce skin tumours.
Študije foto(ko)karcinogenosti so pokazale, da lahko kalciopotriol pri miših poveča učinek UV radiacije, ki sproži nastanek tumorjev na koži.
In one MS, the text “During Daivobet ointment treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight.
V eni državi članici besedilo „Med zdravljenjem z zdravilom Daivobet mazilo naj zdravniki bolnikom priporočajo omejeno ali izogibanje prekomernemu izpostavljanju naravni ali umetni sončni svetlobi.
Let Daivobet remain on the scalp during the night or during the day.
Zdravilo Daivobet je potrebno pustiti na lasišču preko noči ali čez dan.
- Apply Daivobet to the affected area with your fingertips, and rub it in gently until the area affected by psoriasis is covered by a thin layer of gel.
- Zdravilo Daivobet nanesite na prizadeto mesto s konicami prstov in ga nežno vtrite tako, da bo prizadeto mesto pokrito s tanko plastjo gela.
What Daivobet looks like and the contents of the pack Daivobet is an almost clear, colourless to slightly off-white gel filled in high-density polyethylene bottles with low-density polyethylene nozzle and a high-density polyethylene screw cap.
Izgled zdravila Daivobet in vsebina pakiranja Zdravilo Daivobet je skoraj bister, brezbarven do rahlo belkast gel, ki je pakiran v plastenke iz polietilena visoke gostote, opremljene z nastavkom iz polietilena nizke gostote in navojnim pokrovčkom iz polietilena visoke gostote.
Daivobet ointment contains a potent group III steroid and concurrent treatment with other steroids must be avoided.
Daivobet mazilo vsebuje močan steroid skupine III, zato se je potrebno izogibati sočasni uporabi drugih kortikosteroidov.
Daivobet ointment should be applied to the affected area once daily.
Daivobet mazilo nanašamo na prizadete dele enkrat dnevno.
Daivobet gel is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Daivobet gel je kontraindiciran pri eritrodermični, eksfoliativni in pustulozni psoriazi.
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.
Izgled zdravila Daivobet in vsebina pakiranja Daivobet mazilo je belkaste do rumene barve in pakirano v aluminijaste/epoksifenolne tube z navojnim pokrovčkom iz polietilena.
Daivobet gel has no influence on the ability to drive and use machines.
Zdravilo Daivobet nima vpliva na sposobnost vožnje in upravljanja s stroji.
Do not use Daivobet - If you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients of Daivobet - If you have problems with calcium levels in your body (ask your doctor) - If you have certain types of psoriasis: these are erythrodermic, exfoliative and pustular (ask your doctor).
Ne uporabljajte zdravila Daivobet: - če ste alergični (preobčutljivi) na kalcipotriol, betametazon ali katerokoli pomožno snov zdravila Daivobet, - če imate težave z vrednostmi kalcija v telesu (vprašajte svojega zdravnika), - če imate drugo obliko luskavice: te oblike so eritrodermična, eksfoliativna in pustulozna
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).
Učinkovitost uporabe Daivobet gela v odmerku enkrat na dan so določali s pomočjo dveh randomiziranih, dvojno slepih 8-tedenskih kliničnih študij, v katerih je sodelovalo več kot 2.900 bolnikov, ki so imeli vsaj blago psoriazo na lasišču, merjeno po smernicah IGA (Global assessment of disease severity).
The safety and efficacy of Daivobet ointment in children below 18 years have not been established.
Varnost in učinkovitost Daivobet mazila pri otrocih, mlajših od 18 let, nista bili dokazani.
Uncommon (affect less than 1 in 100 people) - Skin pain or irritation - Rash with inflammation of the skin (dermatitis) - Redness of the skin due to widening of the small blood vessels (erythema) - Inflammation or swelling of the hair root (folliculitis) - Changes in skin colour in the area you have used the ointment.
Občasni (pojavijo se pri manj kot pri 1 od 100 bolnikov) - bolečine in draženje kože, - izpuščaj z vnetjem kože (dermatitis), - rdečina kože zaradi razširitve drobnih krvnih žil (eritem), - vnetje ali otekanje lasnih mešičkov (folikulitis), - spremembe barve kože na mestih uporabe mazila.
Daivobet contains calcipotriol and betamethasone.
Daivobet mazilo vsebuje kalcipotriol in betametazon.
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.
O neželenih učinkih zdravila je poročalo 21,7 odstotka bolnikov v skupini, v kateri so uporabljali zdravilo Daivobet mazilo, 29,6 odstotka v skupini, v kateri so izmenjaje uporabljali zdravilo Daivobet mazilo/zdravilo Daivonex ter 37,9 odstotka v skupini z zdravilom Daivonex.
Pack sizes: 15, 30, 60 and 2 x 60 g.
Velikosti pakiranj: 15 g, 30 g, 60 g in 2 x 60 g.
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.
O resnih neželenih učinkih, najverjetneje povezanih z dolgotrajno uporabo kortikosteroida (npr. atrofija kože, folikulitis, depigmentacija, furunkel, purpura), so poročali pri 4,8 % bolnikov v skupini, ki je uporabljala Daivobet mazilo, 2,8 % v skupini, ki je izmenjaje uporabljala Daivobet mazilo in zdravilo Daivonex, ter 2,9 % bolnikov v skupini, ki je uporabljala samo zdravilo Daivonex.
There are no adequate data from the use of Daivobet ointment in pregnant women.
Zadostnih podatkov o uporabi Daivobet mazila med nosečnostjo ni.
Results for the primary response criterion (absent or very mild disease according to the IGA at week 8) showed that Daivobet gel was statistically significantly more effective than Daivonex Scalp solution.
Rezultati po primarnem kriteriju za oceno odgovora (brez znakov bolezni ali zelo blaga oblika bolezni, merjeno po kriterijih IGA po 8 tednih) so pokazali, da je Daivobet gel statistično značilno bolj učinkovit kot zdravilo Daivonex za lasišče.
Before using this medicine, tell your doctor/nurse/pharmacist if - you are using other medicines that contain corticosteroids, as you may get side effects - you have used this medicine for a long time and plan to stop (as there is a risk your psoriasis will get worse or ‘flare up' when steroids are stopped suddenly) - you have diabetes mellitus (diabetes), as your blood sugar/glucose level may be affected by the steroid - your skin becomes infected, as you may need to stop your treatment - you have a certain type of psoriasis called guttate psoriasis - you have serious liver or kidney disease.
Povejte svojemu zdravniku, medicinski sestri ali farmacevtu: - če uporabljate katerokoli drugo zdravilo, ki vsebuje kortikosteroide, saj se lahko pojavijo neželeni učinki, - če zdravilo Daivobet uporabljate že dlje časa in nameravate prekiniti zdravljenje (ker obstaja nevarnost poslabšanja ali ponovnega močnega izbruha luskavice pri nenadni prekinitvi zdravljenja s steroidi), - če imate sladkorno bolezen (diabetes), saj steroid vpliva na raven krvnega sladkorja/glukoze, - če pride do okužbe kože, ker boste v tem primeru morda morali prekiniti zdravljenje, - če imate obliko luskavice, imenovano gutatna luskavica, - če imate hudo bolezen jeter ali ledvic.
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.
Poročali so, da je zaradi nepravilne uporabe Daivobet gela, pri bolniku z močno razširjeno eritrodermno psoriazo, ki je uporabljal 240 g na teden (ustreza dnevnemu odmerku približno 34 g) v obdobju 5 mesecev (maksimalni priporočen odmerek znaša 15 g na dan), prišlo do Cushingovega sindroma in pustulozne psoriaze, kot posledice nenadne prekinitve zdravljenja.
Special precautions - Avoid use on more than 30 % of your body or using more than 15 grams per day - Avoid using under bandages or dressings as it increases the absorption of the steroid - Avoid use on large areas of damaged skin or skin folds (groin, armpits, under breasts) as it increases the absorption of the steroid - Avoid use on the face or genitals (sex organs) as they are very sensitive to steroids - Avoid excessive sunbathing, excessive use of solarium and other forms of light treatment.
Posebna opozorila - izogibajte se uporabi na površini, večji od 30 % telesne površine, in uporabi več kot 15 g zdravila na dan, - izogibajte se uporabi pod povojem ali obvezo, ker njihova uporaba povečuje absorpcijo steroida, - izogibajte se uporabi na večji površini prizadete kože ali v kožnih gubah (dimlje, pazduhi, pod prsmi), ker s tem povečujete absorpcijo steroida, - izogibajte se uporabi na obrazu in spolovilih, ker so zelo občutljivi na steroide, - izogibajte se prekomernemu sončenju, prekomernemu obsevanju v solariju in drugim oblikam obsevanja s svetlobo.
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.
V dodatni študiji, v katero je bilo vključenih 634 bolnikov s psoriazo, je bila opravljena primerjava večkratne ponovitve uporabe Daivobet mazila enkrat dnevno, samega ali izmenjaje z zdravilom Daivonex, v obdobju do 52 tednov, in uporabe samo zdravila Daivonex 48 tednov po začetni uporabi Daivobet mazila.
Results for the primary response criterion (absent or very mild disease according to the IGA at week 8) showed that Daivobet gel was statistically significantly more effective than the comparators.
Rezultati po primarnem kriteriju za oceno odgovora (brez znakov bolezni ali zelo blaga oblika bolezni, merjeno po kriterijih IGA po 8 tednih) so pokazali, da je Daivobet gel statistično značilno bolj učinkovit kot primerjalna zdravila.
Special precautions - Avoid use on more than 30 % of your body or using more than 15 grams per day - Avoid using under a batching cap, bandages or dressings as it increases the absorption of the steroid - Avoid use on large areas of damaged skin or skin folds (groin, armpits, under breasts) as it increases the absorption of the steroid - Avoid use on your face or genitals (sex organs) as they are very sensitive to steroids - Avoid excessive sunbathing, excessive use of solarium and other forms of light treatment.
Posebna opozorila - izogibajte se uporabi na površini, večji od 30 % telesne površine, in uporabi več kot 15 g zdravila na dan, - izogibajte se uporabi pod kopalno kapo in pod povojem ali obvezo, ker njihova uporaba povečuje absorpcijo steroida, - izogibajte se uporabi na večji površini prizadete kože ali v kožnih gubah (dimlje, pazduhi, pod prsmi), ker s tem povečujete absorpcijo steroida, - izogibajte se uporabi na obrazu in spolovilih, ker so zelo občutljivi na steroide, - izogibajte se prekomernemu sončenju, prekomernemu obsevanju v solariju in drugim oblikam obsevanja s svetlobo.
Daivonex Scalp solution (n=105)
zdravilo Daivonex za lasišče (n=105)
If you use other calcipotriol containing medicines, the total amount of calcipotriol medicines must not exceed 15 grams per day and the area treated should not exceed 30 % of the total body surface.
Če za zdravljenje luskavice na telesu hkrati uporabljate druga zdravila, ki vsebujejo kalcipotriol, skupni dnevni odmerek kalcipotriola ne sme presegati 15 g. Zdravila ne smete uporabljati na površini, večji od 30 % celotne telesne površine.
The following serious side effects have been reported for Daivobet Uncommon (affect less than 1 in 100 people) - Worsening of your psoriasis.
V zvezi z uporabo zdravila Daivobet so poročali o naslednjih resnih neželenih učinkih: Občasni (pojavijo se pri manj kot pri 1 od 100 bolnikov) - Poslabšanje luskavice; če pride do poslabšanja bolezni, čimprej obvestite svojega zdravnika.
Daivobet 50 mikrogramov/500 mikrogramov v 1g mazilo
Daivobet 50 mikrogramov/500 mikrogramov v 1 g mazila
In these studies subjects were required to have “psoriasis vulgaris amenable to treatment with topical medication” and subjects who required systemic antipsoriatic treatment or phototherapy were excluded.
Ti študiji sta bili MCB 9802 INT in MCB 9904 INT. Preiskovanci, ki so sodelovali v teh študijah, so morali imeti „psoriazo vulgaris, ki se odziva na zdravljenje z zdravili za topično uporabo“, preiskovanci, ki so potrebovali sistemsko zdravljenje psoriaze ali fototerapijo, pa so bili izključeni.
- 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).
- spremembe pri rasti las, - rdeč izpuščaj okrog ust (perioralni dermatitis), - izpuščaj na koži z vnetjem in otekanjem kože (alergijski kontaktni dermatitis), - svetleče rjave gnojne pike (koloidna milia), - posvetlitev barve kože (depigmentacija).
Carton text:
Besedilo na škatli:
NAME OF THE MEDICINAL PRODUCT [To be completed nationally]
NAČIN IZDAJANJA ZDRAVILA [izpolni država članica]
During Daivobet gel treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight.
Med zdravljenjem z gelom Daivobet priporočamo zdravnikom, da svetujejo bolniku, naj omeji ali opusti pretirano izpostavljanje naravni ali umetni sončni svetlobi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Daivobet ointment in tubes of 3 g
PODATKI NA ZUNANJI OVOJNINI Daivobet mazilo v tubah po 3 g
In reproduction toxicity studies with long-term oral administration of corticosteroids to rats, prolonged gestation and prolonged and difficult labour were detected.
V študijah vpliva na sposobnost razmnoževanja pri dolgotrajni oralni uporabi kortikosteroidov pri podganah so ugotovili podaljšan čas brejosti, daljši porod in težave pri kotenju.
With regards to HPA suppression, therefore, this study shows some evidence that very high doses of Daivobet gel and ointment may have a weak effect on the HPA axis.”
V zvezi s hipotalamično-hipofiznoadrenalno (HPA) supresijo pa iz študije izhajajo nekateri dokazi, da imajo lahko zelo veliki odmerki zdravila Daivobet gel in mazilo šibak vpliv na hipotalamično-hipofizno-adrenalno (HPA) os.“
• the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Daivobet and associated names (see Annex I).
• Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih je predlagal imetnik dovoljenja za promet, so bili ocenjeni na osnovi predložene dokumentacije in strokovne razprave v Odboru.
High-density polyethylene bottles with low-density polyethylene nozzle and a high-density polyethylene screw cap.
Plastenka iz polietilena visoke gostote z nastavkom iz polietilena nizke gostote in z navojnim pokrovčkom iz polietilena visoke gostote.
The MAH proposed a wording in line with the MRP SPC that alreadly largely reflected the wording of the national SPCs of several MSs.
Imetnik dovoljenja za promet z zdravilom je predlagal besedilo v skladu s povzetkom glavnih značilnosti zdravila iz postopka medsebojnega priznavanja, ki je v veliki meri odražalo besedilo nacionalnih povzetkov glavnih značilnosti zdravila v več državah članicah.
If you have scalp psoriasis - Before applying Daivobet to the scalp, comb the hair to remove any loose scales.
Pri psoriazi na lasišču: - Pred nanosom zdravila Daivobet na lasišče, počešite lase, da odstranite morebitne luske.
PHARMACEUTICAL FORM AND CONTENTS Ointment
FARMACEVTSKA OBLIKA IN VSEBINA mazilo
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.
V kliničnih študijah, kjer so uporabili radiološko označeno mazilo, so ugotovili, da je sistemska absorbcija kalcipotriola in betametazona iz Daivobet mazila manj kot 1 % uporabljenega odmerka (2,5 g), če ga uporabljamo na zdravi koži (625 cm2) v obdobju 12 ur.
Daivobet ointment is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Daivobet mazilo je kontraindicirano pri eritrodermični, eksfoliativni in pustulozni psoriazi.
During Daivobet ointment treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight.
Med zdravljenjem z Daivobet mazilom priporočamo zdravnikom, da svetujejo bolniku, naj omeji ali opusti pretirano izpostavljanje naravni ali umetni sončni svetlobi.
The efficacy of once daily use of Daivobet gel on non-scalp regions of the body was investigated in a randomised, double-blind, 8-week clinical study including 296 patients with psoriasis vulgaris of mild or moderate severity according to the IGA.
Učinkovitost uporabe Daivobet gela v odmerku enkrat na dan so določali s pomočjo randomizirane, dvojno slepe 8-tedenske klinične študije, v kateri je sodelovalo več kot 296 bolnikov, ki so imeli blago ali zmerno psoriazo vulgaris po telesu, merjeno po smernicah IGA.
Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy in adults.
Topikalno zdravljenje stabilne psoriaze vulgaris v plakih pri odraslih, kjer je mogoče topikalno zdravljenje.