FrancophonIA/ELRC3.0 huggingface dataset:
English: It may be necessary for you to stop this medicine gradually, especially if you have used it for a long time.
Slovenian: Zdravljenje bo morda potrebno zaključiti postopoma, posebno če ste zdravilo Daivobet uporabljali daljši čas.
English: Excipient: 160 micrograms butylated hydroxytoluene/g gel For a full list of excipients, see section 6.1.
Slovenian: Pomožna snov: 160 mikrogramov butiliranega hidroksitoluena v 1 g gel Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Controlled disease was defined as ‘clear' or ‘minimal disease' for patients with moderate disease at baseline or ‘clear' for patients with mild disease at baseline.
Slovenian: Nadzorovana bolezen je bila opredeljena kot »čista«, pri bolnikih z zelo blago boleznijo ob začetku zdravljenja, ali »minimalna«, pri bolnikih z zmernimi bolezenskimi znaki ob začetku zdravljenja.
English: Section 4.9 - Overdose
Slovenian: Poglavje 4.9 - Prekomerno odmerjanje
English: Many patients who respond well to Daivobet ointment over the recommended 4 week treatment period still require repeated treatment for long term control of their psoriasis.
Slovenian: Več bolnikov, ki se je na priporočeno štiritedensko zdravljenje z zdravilom Daivobet mazilo dobro odzvalo, je za dolgotrajno obvladovanje psoriaze potrebovalo še nadaljnje zdravljenje.
English: Concurrent treatment and UV exposure
Slovenian: Sočasno zdravljenje in izpostavljenost UV žarkom
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 25 °C.
English: Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria (see section 4.4).
Slovenian: V zelo redkih primerih se po topikalni uporabi lahko pojavijo sistemski učinki, kot npr. hiperkalciemija ali hiperkalciurija (glejte poglavje 4.4).
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.
Slovenian: Lahko se pojavijo zaviranje delovanja skorje nadledvične žleze, katarakta, infekcije, vpliv na nadzor sladkorne bolezni in povišanje intraokularnega tlaka, zlasti po dolgotrajni uporabi.
English: The text for the outer packaging (carton) and immediate packaging (bottle) is the same, except where it is indicated to apply for carton or bottle, respectively.
Slovenian: Besedilo za zunanjo ovojnino (škatla iz kartona) in stično ovojnino (plastenka) je enako, razen kjer je posebej navedeno, da se uporablja za škatlo ali plastenko.
English: When the gel and scalp psoriasis were assessed, other treatments were permitted for body psoriasis.
Slovenian: Po ocenjevanju gela in psoriaze lasišča so bila dovoljena druga zdravila za zdravljenje psoriaze telesa.
English: If you stop using Daivobet
Slovenian: Če ste prenehali uporabljati zdravilo Daivobet
English: The CHMP proposed that the MAH either omits a weekly dose and endorsed the following: “When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g.”
Slovenian: CHMP je predlagal, da imetnik dovoljenja za promet z zdravilom izključi tedenski odmerek, in potrdil besedilo: „Pri uporabi zdravil, ki vsebujejo kalcipotriol, največji dnevni odmerek zdravila ne sme preseči 15 g“.
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA [izpolni država članica]
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.
Slovenian: V potrditev učinkovitosti in varnosti zdravila Daivobet mazilo pri uporabi na telesu so bile predložene tudi druge študije (MCB 9802 INT in MCB 9904 INT), bolniki, ki so sodelovali v teh študijah, pa so lahko za zdravljenje psoriaze lasišča uporabljali tudi druga topična zdravila.
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.
Slovenian: CHMP je menil, da je izjava „Po tem obdobju zdravljenja se lahko ponovno zdravljenje z zdravilom Daivobet mazilo prične le pod zdravniškim nadzorom“ nejasna, saj zdravljenje z zdravilom Daivobet lahko prične le zdravnik, zdravljenje pa naj bi se tudi spremljalo.
English: Note: This SPC, labelling and package leaflet is the version valid at the time of Commission Decision.
Slovenian: Opomba: Ta različica povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo je različica, ki je veljavna ob izdaji sklepa Evropske komisije.
English: In case of chronic toxicity the corticosteroid treatment must be discontinued gradually.
Slovenian: V primeru kronične toksičnosti je zdravljenje s kortikosteroidi potrebno postopno prekiniti.
English: Studies of corticosteroids in animals have shown reproductive toxicity (cleft palate, skeletal malformations).
Slovenian: Študije s kortikosteroidi na živalih so pokazale vpliv kortikosteroidov na sposobnost razmnoževanja (volčje žrelo, malformacije okostja).
English: Therefore, during pregnancy, Daivobet ointment should only be used when the potential benefit justifies the potential risk.
Slovenian: Daivobet mazilo se med nosečnostjo lahko uporablja le, če potencialne koristi opravičujejo morebitno tveganje.
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.
Slovenian: Spremenjen je bil vrstni red informacij, besedilo pa je bilo preoblikovano v skladu s podatki v povzetku glavnih značilnosti zdravila Daivobet gel: iz opredelitve betametazon dipropionata, ki je opredeljen kot močan steroid iz skupine III, je bila izbrisana beseda „močno“.
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Slovenian: Torej ta povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo morda ne predstavljajo trenutnih besedil.
English: week 2 week 8
Slovenian: 2. teden 8. teden
English: The CHMP asked the MAH to clarify the adverse events of concern possibly related to long term corticoid use.
Slovenian: CHMP je imetnika dovoljenja za promet z zdravilom zaprosil za pojasnitev neželenih učinkov, ki so lahko povezani z dolgotrajno uporabo kortikosteroidov.
English: In two MS's the text “When lesions become secondarily infected, they should be treated with antimicrobiological therapy.
Slovenian: V dveh državah članicah besedilo „V primeru sekundarne okužbe lezij je potrebno zdravljenje s proti mikrobiološkimi zdravili.
English: Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long term treatment (see section 4.4).
Slovenian: Sistemski učinki se pogosteje pojavijo, če zdravilo uporabimo pod okluzijo (plastika, kožne gube), pri uporabi zdravila na velikih površinah kože ali po dolgotrajni uporabi (glejte poglavje 4.4).
English: One SPC did not include information about the possibility of increased absorption of topical steroids under occlusive dressings.
Slovenian: En povzetek glavnih značilnosti zdravila ni vključeval informacij o možnosti povečane absorpcije topičnih steroidov pod okluzivnim povojem.
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 %).
Slovenian: Neželena učinka zdravila, o katerih sta poročala več kot 2 odstotka bolnikov v skupini z zdravilom Daivobet mazilo, sta bila pruritus (5,8 odstotka) in psoriaza (5,3 odstotka).
English: What Daivobet is and what it is used for Before you use Daivobet How to use Daivobet Possible side effects How to store Daivobet Further information
Slovenian: Kaj je zdravilo Daivobet in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Daivobet Kako uporabljati zdravilo Daivobet Možni neželeni učinki
English: These areas should only be treated with weaker corticosteroids” was either partly or not included in the SPC.
Slovenian: Ti deli kože naj se zdravijo samo s šibkejšimi kortikosteroidi“ le deloma vključeno ali povsem izključeno iz povzetka glavnih značilnosti zdravila.
English: Therefore it was proposed to add the wording “the maximum daily dose should not exceed 15 g, and the maximum weekly dose should not exceed 100 g” and “the body surface area treated with calcipotriol containing products should not exceed 30%”.
Slovenian: Predlagano je bilo, da se doda besedilo „največji dnevni odmerek ne sme preseči 15 g in največji tedenski odmerek na sme preseči 100 g“ ter „površina telesa, ki se zdravi z zdravilom, ki vsebuje kalcipotriol, ne sme preseči 30 odstotkov“.
English: The bottle should be shaken before use and Daivobet gel applied to the affected area.
Slovenian: Pred uporabo pretresite stekleničko in nanesite Daivobet gel na prizadeto mesto.
English: ≥1/100 to <1/10
Slovenian: ≥ 1/100 do < 1/10
English: Following systemic exposure, both active ingredients - calcipotriol and betamethasone dipropionateare rapidly and extensively metabolised.
Slovenian: Po sistemski izpostavljenosti sta obe zdravilni učinkovini - kalcipotriol in betametazone dipropionathitro in v veliki meri presnovljeni.
English: Due to the content of calcipotriol, hypercalcaemia may occur if the maximum daily dose (15 g) is exceeded.
Slovenian: Ker zdravilo vsebuje kalcipotriol, se ob prekoračitvi največjega dnevnega odmerka (15 g) lahko pojavi hiperkalciemija.
English: Information on use in children has been updated by the MAH according to the Quality Review of Documents guidance.
Slovenian: Imetnik dovoljenja za promet z zdravilom je v skladu z navodili iz pregleda kakovosti dokumentov posodobil tudi informacije o uporabi pri otrocih.
English: Absorption through damaged skin is approx. 24 %.
Slovenian: Skozi poškodovano kožo se absorbira pribl.
English: How to put on Daivobet: Cutaneous use.
Slovenian: Kako nanesti zdravilo Daivobet: uporaba na koži.
English: Topical calcipotriol should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks (see section 5.3).
Slovenian: Topikalni kalcipotriol lahko v kombinaciji z UV obsevanjem uporabljamo le, če zdravnik in bolnik smatrata, da potencialne koristi opravičujejo morebitna tveganja (glejte poglavje 5.3).
English: How to store Daivobet Further information
Slovenian: Shranjevanje zdravila Daivobet Dodatne informacije
English: Subjects with unstable psoriasis (erythrodermic, exfoliative or pustular psoriasis) were excluded.
Slovenian: Preiskovanci z nestabilno psoriazo (eritrodermično, eksfoliativno ali pustularno psoriazo) so bili izključeni.
English: Daivobet ointment is a combination product which contains the vitamin D analogue, calcipotriol monohydrate and betamethasone dipropionate.
Slovenian: Zdravilo Daivobet mazilo je kombinirano zdravilo, ki vsebuje analog vitamina D, kalcipotriol monohidrat in betametazon dipropionat.
English: The CHMP endorsed the harmonised text under this section.
Slovenian: CHMP je potrdil usklajeno besedilo v tem poglavju.
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.
Slovenian: Daivobet gel vsebuje butiliran hidroksitoluen (E321), ki lahko povzroči lokalne reakcije na koži (npr. kontaktni dermatitis) ali draženje oči in sluznice.
English: The CHMP did not consider necessary to provide the detail of the photocarcinogenicity study and endorsed the following: "Photo(co)carcinogenicity studies in mice suggest that calcipotriol may enhance the effect of UVR to induce skin tumours".
Slovenian: CHMP je menil, da ni treba vključiti podrobnosti iz študije fotokancerogenosti in potrdil naslednje: „Študije foto(ko)kancerogenosti pri miših kažejo, da lahko kalcipotriol okrepi vpliv ultravijoličnega sevanja na nastanek kožnih tumorjev.“
English: ≥1/10,000 to <1/1,000
Slovenian: ≥ 1/10.000 do < 1/1.000
English: Section 5.3 - Preclinical safety data
Slovenian: Poglavje 5.3 - Predklinični podatki o varnosti
English: Daivobet gel should be applied to affected areas once daily.
Slovenian: Daivobet gel nanašamo na prizadete dele enkrat dnevno.
English: In several MS's the statement “treatment of more than 30% of the body surface should be avoided” was not included in the SPC and the MAH proposed to include this wording under section 4.4.
Slovenian: V več državah članicah izjava „izogibati se je treba zdravljenju več kot 30 odstotkov kože“ ni bila vključena v povzetek glavnih značilnosti zdravila in imetnik dovoljenja za promet z zdravilom je predlagal vključitev tega besedila v poglavje 4.4.
English: Use above the recommended dose may cause elevated serum calcium which should rapidly subside when treatment is discontinued.
Slovenian: Uporaba odmerkov, večjih od priporočenih, lahko povzroči zvišanje koncentracije kalcija v serumu, ki pa se hitro zniža, ko zdravljenje prekinemo.
English: Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4 g corresponds to one teaspoon).
Slovenian: Običajno je količina zdravila od 1 do 4 g dovolj za enkratno uporabo na lasišču (4 g odgovarja 1 čajni žlički).
English: Daivobet gel is a different formulation which contains the same active substances in the same concentrations as in Daivobet ointment.
Slovenian: Zdravilo Daivobet gel je le drugačna formulacija, ki vsebuje enake zdravilne učinkovine v enakih koncentracijah kot zdravilo Daivobet mazilo.
English: Daivobet gel should remain on the skin during the night or during the day.
Slovenian: Daivobet gel naj učinkuje na koži čez noč ali čez dan.
English: When treating psoriasis there may be a risk of generalised pustular psoriasis.
Slovenian: Pri zdravljenju psoriaze obstaja možnost nastanka generalizirane pustulozne psoriaze.
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.
Slovenian: V študiji MBL 0404 FR so proučili tudi sistemske učinke kombinirane uporabe zdravila Daivobet get (uporabljeno na lasišču) in zdravila Daivobet mazilo (uporabljeno na telesu) pri bolnikih s psoriazo vulgaris na teh površinah.
English: The MAH accepted the recommendation for rewording section 4.2 and the CHMP endorsed the proposed wording: “If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular medical supervision”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je sprejel predlagano spremembo besedila v poglavju 4.2 in CHMP je potrdil predlagano besedilo: „Če je po zdravljenju potrebno nadaljnje ali ponovno zdravljenje, se zdravljenje lahko nadaljuje le po medicinskem pregledu in pod rednim zdravniškim nadzorom“.
English: A dermal carcinogenicity study with calcipotriol in mice revealed no special hazard to humans.
Slovenian: Študije dermalne kancerogenosti s kalcipotriolom, opravljene na miših, niso pokazale posebnih tveganj za človeka.
English: Bottle text: 15 g
Slovenian: Besedilo na plastenki: 15 g
English: This causes redness, scaling and thickness of your skin.
Slovenian: Zaradi tega se pojavijo rdečina, luščenje in zadebelitev kože.
English: Pack sizes: 15 g
Slovenian: Velikosti pakiranj: 15 g
English: These side effects are more likely to happen after long-term use, use in skin folds (e.g. groin, armpits or under breasts), use under bandages or dressings or use on large areas of skin.
Slovenian: Ti neželeni učinki se največkrat pojavijo po dolgotrajni uporabi, uporabi v kožnih gubah (npr. dimlje, pazduhi, pod prsmi), uporabi pod povojem ali obvezo in uporabi na večji površini kože.
English: After first opening: 3 months.
Slovenian: Rok uporabnosti po prvem odpiranju: 3 mesece.
English: ≥1/1,000 to <1/100
Slovenian: ≥ 1/1.000 do < 1/100
English: Less serious side effects
Slovenian: Manj resni neželeni učinki
English: The purpose of this Art 30 referral is to harmonise the SPC across EU member states for Daivobet ointment authorised via the Mutual Regognition Procedure (MRP) and the national authorisation.
Slovenian: Napotitev v skladu s členom 30 je namenjena uskladitvi povzetkov glavnih značilnosti zdravila Daivobet mazilo v državah članicah EU s postopkom medsebojnega priznavanja in z nacionalno odobritvijo.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS, TUBE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH, TUBAH
English: If your doctor has agreed that you can breast-feed, take care and do not apply Daivobet to the breast area.
Slovenian: Če je vaš zdravnik odobril dojenje, pazite, da zdravila Daivobet ne boste nanašali na predel prsi.
English: This can be serious and you should contact your doctor as soon as possible.
Slovenian: Stanje je lahko resno, zato morate o tem čimprej obvestiti svojega zdravnika.
English: Uncommon undesirable effects are skin pain or irritation, dermatitis, erythema, exacerbation of psoriasis, folliculitis and application site pigmentation changes.
Slovenian: Občasni neželeni učinki so bolečine ali razdraženost kože, dermatitis, eritem, poslabšanje psoriaze, folikulitis in pigmentacijske spremembe na mestu nanašanja.
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.
Slovenian: Kot je bilo navedeno poglavju 4.4, so bile vključene informacije o rezultatih klinične študije MBL 0404 FR, ki so pokazali odziv nadledvične žleze na adrenokortikotropni hormon (ACTH).
English: INFORMATION IN BRAILLE Carton for 3 g pack size: [To be completed nationally] Daivobet ointment
Slovenian: PODATKI V BRAILLOVI PISAVI Škatla iz kartona za velikost pakiranja 3 g: [izpolni država članica] Daivobet mazilo
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).
Slovenian: Občasne lokalne neželene učinke (kot je draženje oči ali draženje kože na obrazu) so opazili v primeru nehotenega nanosa zdravila na obraz, oči in beločnici (glejte poglavji 4.8 in 5.1).
English: Calcipotriol (n=67)
Slovenian: kalcipotriol (n=67)
English: Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, antipruritic, vasoconstrictive and immunosuppresive properties, however, without curing the underlying condition.
Slovenian: Tako kot drugi kortikosteroidi za topikalno uporabo, ima betametazondipropionat protivnetne, antipruritične, vazokonstriktorne in imunosupresivne lastnosti, čeprav osnovnih bolezni ne pozdravi.
English: However, if infection worsens, treatment with corticosteroids should be stopped” was not included in the SPC.
Slovenian: Če se okužba poslabša, pa je treba zdravljenje s kortikosteroidi zaustaviti“ ni bilo vključeno v povzetek glavnih značilnosti zdravila.
English: No carcinogenicity or photocarcinogenicity studies have been performed with betamethasone dipropionate.
Slovenian: Z betametazondipropionatom še ni bilo opravljenih nobenih študij karcinogenosti oziroma fotokarcinogenosti.
English: With long-term use there is an increased risk of local and systemic corticosteroid adverse reactions.
Slovenian: Pri dolgotrajni uporabi se poveča tveganje za pojav lokalnih in sistemskih neželenih učinkov zaradi kortikosteroida.
English: Penetration through the stratum corneum is enhanced under occlusion thus the addition of this information would make the clinician aware of this possibility.
Slovenian: Prehajanje skozi tanko roženo plast pokožnice je pod okluzijo izboljšano, zato bodo z vključitvijo te informacije na to možnost opozorjeni tudi zdravniki.
English: The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively:
Slovenian: Naslednji neželeni učinki so najverjetneje povezani s farmakološkimi razredi kalcipotriola oziroma betametazona:
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.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Daivobet Zdravilo Daivobet vsebuje butiliran hidroksitoluen (E321), ki lahko povzroči lokalne reakcije na koži (npr. kontaktni dermatitis) ali draženje oči in sluznice.
English: Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions, resulting in secondary adrenal insufficiency which is usually reversible.
Slovenian: Dolgotrajna topikalna uporaba prevelikih odmerkov kortikosteroidov lahko zavre delovanje hipofize in nadledvične žleze, kar povzroči sekundarno adrenalno insuficienco, ki je običajno reverzibilna.
English: If any of them last a long time or cause you problems, you should tell your doctor or nurse.
Slovenian: Če učinki dalj časa ne izginejo in vam povzročajo težave, morate čimprej obvestiti svojega zdravnika ali medicinsko sestro.
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).
Slovenian: Glavna pot izločanja kalcipotriola je z blatom (podgane in mini prašički), betametazona dipropionata pa z urinom (podgane in miši).
English: Your doctor may need to carry out blood tests to check that using too much gel has not caused a problem with calcium in your blood.
Slovenian: Vaš zdravnik vas bo mogoče poslal na pregled krvi, da bi ugotovil, ali prekomerna uporaba gela ne povzroča nenormalne koncentracije kalcija v krvi.
English: The CHMP found the MAH's proposal appropriate and acceptable and endorsed the harmonised wording under this section.
Slovenian: CHMP je menil, da je predlog imetnika dovoljenja za promet z zdravilom ustrezen in sprejemljiv ter potrdil usklajeno besedilo v tem poglavju.
English: One metabolite of calcipotriol and one metabolite of betamethasone dipropionate were quantifiable in some of the patients.”
Slovenian: En presnovek kalcipotriola in en presnovek betametazone dipropionata je bilo pri nekaterih bolnikih možno kvantificirati.“
English: In two MSs the SPC did not include the information on the spontaneous report of overdose of Daivobet ointment.
Slovenian: Povzetek glavnih značilnosti zdravila v dveh državah članicah ni vključeval informacij iz spontanega poročila o prevelikem odmerjanju zdravila Daivobet mazilo.
English: Betamethasone passes into breast milk but risk of an adverse effect on the infant seems unlikely with therapeutic doses.
Slovenian: Betametazon sicer prehaja v materino mleko, vendar je verjetnost, da bi prišlo do neželenih učinkov pri dojenčku ob uporabi terapevtskih odmerkov zanemarljiva.
English: Therefore the MAH proposed a text more specific regarding the known cutaneous effects of betamethasone dipropionate.
Slovenian: Tako je imetnik dovoljenja za promet z zdravilom predlagal natančnejše besedilo v zvezi z znanimi kožnimi učinki betametazone dipropionata.
English: Daivobet has no or negligible influence on the ability to drive and to use machines.
Slovenian: Zdravilo Daivobet nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally]
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT [izpolni država članica]
English: Daivobet ointment should be applied to the affected area.
Slovenian: Daivobet mazilo je potrebno nanesti na prizadeto mesto.