FrancophonIA/ELRC3.0 huggingface dataset:
English: Application to psoriasis plaques and under occlusive dressings may increase the absorption of topical corticosteroids.
Slovenian: Nanašanje na plake psoriaze in pod okluzivnim povojem lahko poveča absorpcijo topičnih kortikosteroidov.
English: Betamethasone (as dipropionate)
Slovenian: Betametazon (v obliki dipropionata)
English: Results for speed of onset based on similar data at week 2 also showed Daivobet gel to be statistically significantly more effective than the comparators.
Slovenian: Rezultati glede hitrosti nastopa učinkov, ki so temeljili na podobnih podatkih za 2. teden zdravljenja, so prav tako pokazali, da je bil Daivobet gel statistično značilno bolj učinkovit kot primerjalna zdravila.
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.
Slovenian: V literaturi je bilo poročano o nekaj primerih hiperkalcemije, ki se je pojavila kot posledici prekomerne izpostavljenosti kalcipotriolu, zato je CHMP potrdil predlog imetnika dovoljenja za promet z zdravilom ter dodal sklic na poglavje 4.2.
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)” was not included in the SPC.
Slovenian: Topični kalcipotriol se lahko uporablja z ultravijoličnim sevanjem le, kadar zdravnik in bolnik menita, da možne koristi odtehtajo možna tveganja (glejte poglavje 5.3)“ ni bilo vključeno v povzetek glavnih značilnosti zdravila.
English: Studies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated no impairment of male and female fertility.
Slovenian: Študije na podganah pri uporabi peroralnih odmerkov kalcipotriola in betametazondipropionata niso pokazale poslabšanja moške ali ženske plodnosti.
English: Pustular psoriasis has been reported rarely.
Slovenian: Redko so poročali o pustulozni psoriazi.
English: The recommended treatment period is 4 weeks for scalp areas and 8 weeks for “non-scalp” areas.
Slovenian: Priporočljivo trajanje zdravljenja je 4 tedne za lasišče in 8 tednov za kožo po telesu.
English: Your doctor may need to carry out blood tests to check that using too much ointment 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 mazila ne povzroča nenormalne koncentracije kalcija v krvi.
English: The expiry date refers to the last day of that month - Do not refrigerate.
Slovenian: Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Local adverse reactions
Slovenian: Lokalni neželeni učinki
English: The treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid (see section 4.8).
Slovenian: V primeru pojava neželenih učinkov zaradi dolgotrajne uporabe kortikosteroidov je potrebno zdravljenje prekiniti (glejte poglavje 4.8).
English: Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone acts to reduce inflammation.
Slovenian: Kalcipotriol normalizira hitrost rasti kožnih celic, betametazon pa zmanjšuje vnetje.
English: These side effects are more likely to happen after long-term use, or use under occlusion.
Slovenian: Ti neželeni učinki se največkrat pojavijo po dolgotrajni uporabi ali uporabi zdravila pod povojem ali obvezo.
English: Children Daivobet is not recommended for the use in children below the age of 18 years.
Slovenian: Otroci Uporabe zdravila Daivobet pri otrocih, mlajših od 18 let, ne priporočamo.
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.
Slovenian: Kontraindikacija pri erupcijski psoriazi je bila prav tako vključena v povzetek glavnih značilnosti zdravila na podlagi izključitve iz programa kliničnih preskušanj.
English: The contraindication in patients with known disorder of calcium metabolism seemed appropriate by the CHMP that endorsed the following: “Due to the content of calcipotriol Daivobet ointment is contraindicated in patients with known disorders of calcium metabolism”.
Slovenian: CHMP je menil, da je kontraindikacija pri bolnikih z znano motnjo presnavljanja kalcija primerna in potrdil naslednje besedilo: „Zaradi vsebnosti kalcipotriola je zdravilo Daivobet mazilo pri bolnikih z znanimi motnjami pri presnavljanju kalcija kontraindicirano.“
English: INFORMATION IN BRAILLE [To be completed nationally] Carton text: Daivobet gel.
Slovenian: PODATKI V BRAILLOVI PISAVI [izpolni država članica] Besedilo na škatli: Daivobet gel
English: The MAH replied that they would prefer to keep the detailed description of the tests because their result indicates a reduction in the time required for UVR to induce the formation of skin tumours in male mice.
Slovenian: Imetnik dovoljenja za promet z zdravilom je odgovoril, da želijo ohraniti podroben opis preskusov, saj njihovi rezultati kažejo, da lahko ultravijolično sevanje v krajšem času vpliva na nastanek kožnih tumorjev pri mišjih samcih.
English: The MAH proposed the deletion of locally from the following: “There is no experience with concurrent use of other anti-psoriatic products administered locally or systemically or with phototherapy”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal izbris besede lokalno iz naslednjega besedila: „Ni izkušenj s sočasno uporabo z drugimi antipsoriatičnimi zdravili, ki se uporabljajo lokalno ali sistemsko ali s fototerapijo.“
English: Most patients see obvious results after 2 weeks, even if the psoriasis is not yet cleared at that point.
Slovenian: Kaj lahko pričakujete, če uporabljate zdravilo Daivobet Večina bolnikov opazi jasne znake izboljšanja po 2 tednih, kljub temu, da luskavica v tem času še ni odpravljena.
English: In one MSs SPC was not included the information that after a period of 4 weeks repeated treatment with Daivobet ointment can be initiated under medical supervision.
Slovenian: V povzetku glavnih značilnosti zdravila ene izmed držav članic ni bil vključen podatek, da se lahko štiri tedne po zdravljenju z zdravilom Daivobet mazilo prične nadaljnje zdravljenje pod zdravniškim nadzorom.
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.
Slovenian: CHMP je prav tako potrdil besedilo „vpliv na metabolno urejenost pri sladkorni bolezni“ kot neželeni učinek betametazona dipropionata v skladu s sklicevanjem iz poglavja 4.4.
English: Betamethasone dipropionate (n=1,118)
Slovenian: betametazondipropionat (n=1.118)
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).
Slovenian: Razlike v pojavnosti nastanka neželenih dogodkov med obema skupinama (2,6 % v skupini, ki je prejemala Daivobet gel in 3 % v skupini, ki je prejemala kalcipotriol; P=0,73) ni bilo.
English: The mechanism of the antiinflammatory activity of the topical steroids, in general, is unclear.
Slovenian: Natančni mehanizem protivnetnega delovanja topikalnih steroidov ni povsem pojasnjen.
English: Gel vehicle (n=136)
Slovenian: gel (n=136)
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.
Slovenian: V študiji MBL 0404 FR, ki je bila izvedena za razvoj zdravila Daivobet gel, so proučevali odziv nadledvične žleze na adrenokortikotropni hormon (ACTH), rezultati študije pa so bili vključeni v odobren povzetek glavnih značilnosti zdravila Daivobet gel.
English: With regard 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.
Slovenian: Glede zaviranja HPA je ta študija pokazala, da zelo veliki odmerki gela in Daivobet mazila lahko blažje vplivajo na os HPA.
English: However, if infection worsens, treatment with corticosteroids should be stopped.
Slovenian: Če pride do poslabšanja okužbe, pa je zdravljenje s kortikosteroidi potrebno prekiniti.
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).
Slovenian: V študijah pri bolnikih, ki so imeli močno razširjeno psoriazo tako na lasišču kot po telesu in so uporabljali kombinacijo velikih odmerkov Daivobet gela (uporaba na lasišču) in Daivobet mazila (uporaba po telesu), so po 4 tednih pri 5 od 32 bolnikov ugotovili mejno znižanje koncentracije kortizola kot odgovor na obremenitev z adrenokortikotropnim hormonom (ACTH) (glejte poglavje
English: Less serious side effects known to be caused by calcipotriol include the following - Sensitivity of the skin to light resulting in a rash - Eczema.
Slovenian: Manj resni neželeni učinki, ki so posledica kalcipotriola, so naslednji: - občutljivost kože na svetlobo, ki povzroči izpuščaj, - ekcem.
English: Comparators were betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and (in one of the studies) the gel vehicle alone, all used once daily.
Slovenian: Za primerjavo so uporabljali betametazondipropionat gel, kalcipotriol gel in gel brez učinkovine (v eni študiji), vse enkrat na dan.
English: Write the date you first opened the tube in the space provided on the carton.
Slovenian: V predvideni prostor na škatli vpišite datum prvega odprtja tube.
English: In local tolerability studies in rabbits, Daivobet gel caused mild to moderate skin irritation and a slight transient irritation of the eye.
Slovenian: V študijah lokalne tolerance Daivobet gela, ki so jih opravili na kuncih, so opazili blago do zmerno draženje kože in rahlo, prehodno, draženje oči.
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.
Slovenian: Lokalne reakcije, ki se lahko pojavijo po topikalni uporabi, še posebej, če ta traja dalj časa, vključujejo atrofijo kože, teleangiektazije, strije, folikulitis, hipertrihozo, perioralni dermatitis, alergijski kontaktni dermatitis, depigmentacijo in koloidno milio.
English: Adverse reactions found in connection with systemic corticosteroid treatment, such as adrenocortical suppression or impact on the metabolic control of diabetes mellitus, may occur also during topical corticosteroid treatment due to systemic absorption.
Slovenian: Neželeni učinki, ki so jih ugotovili pri sistemskem zdravljenju s kortikosteroidi, kot npr. supresija delovanja skorje nadledvične žleze ali pa vpliv na nadzor sladkorne bolezni, se lahko zaradi sistemske absorpcije zdravila pojavijo tudi med topikalnim zdravljenjem s kortikosteroidi.
English: After first opening: 1 year.
Slovenian: Rok uporabnosti po prvem odpiranju: 1 leto.
English: Adverse events possibly related to long-term use of corticosteroids on the scalp, were identified by an independent, blinded panel of dermatologists.
Slovenian: Neželene učinke, ki so najverjetneje nastali zaradi dolgotrajne uporabe kortikosteroida na lasišču, so ugotavljali s pomočjo neodvisne skupine dermatologov.
English: LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55 DK-2750 Ballerup Denmark
Slovenian: LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55 DK-2750 Ballerup Danska
English: The MAH believed that the addition of this information would give the clinician a useful short summary of the derivation of the data in this section and the more uncommon undesirable effects of Daivobet ointment.
Slovenian: Pustularna psoriaza je redek neželen učinek.“ Imetnik dovoljenja za promet z zdravilom je menil, da bi dodajanje te informacije zdravnikom ponudilo kratek povzetek izpeljave podatkov iz tega poglavja in bolj občasnih neželenih učinkov zdravila Daivobet mazilo.
English: Less serious side effects known to be caused by calcipotriol include the following - Dry skin - Sensitivity of the skin to light resulting in a rash has also been reported - Eczema.
Slovenian: Manj resni neželeni učinki, ki so posledica kalcipotriola, so naslednji: - suha koža, - poročali so tudi o občutljivosti kože na svetlobo, ki povzroči izpuščaj, - ekcem.
English: The risk of rebound effect has been included in the SPC based on data from post marketing use.
Slovenian: Nevarnost odtegnitvenih učinkov je bila vključena v povzetek glavnih značilnosti zdravila na podlagi podatkov, pridobljenih v času trženja.
English: The safety and efficacy of Daivobet gel in children below 18 years have not been established.
Slovenian: Varnost in učinkovitost Daivobet gela pri otrocih, mlajših od 18 let, nista bili dokazani.
English: Gel vehicle (n=35)
Slovenian: gel (n=35)
English: The safety and efficacy of Daivobet gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Slovenian: Varnost in učinkovitost Daivobet gela pri bolnikih s hudo ledvično insuficienco ali hudo okvaro jeter nista bili ovrednoteni.
English: In three MSs the wording regarding contraindications of corticosteroids was more general than in the MRP SPC.
Slovenian: V treh državah članicah je bilo besedilo v povzetkih glavnih značilnosti zdravila v zvezi s kontraindikacijami za kortikosteroide bolj splošno kot v povzetku glavnih značilnosti zdravila iz postopka medsebojnega priznavanja.
English: The safety and efficacy of Daivobet ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Slovenian: Varnost in učinkovitost Daivobet mazila pri bolnikih s hudo ledvično insuficienco ali hudo okvaro jeter nista bili ovrednoteni.
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.
Slovenian: Besedilo „vpliv na metabolno urejenost pri sladkorni bolezni“ je bilo dodano k neželenim učinkom betametazon dipropionata, kot je navedeno že v poglavju 4.4 povzetka glavnih značilnosti zdravila iz decentraliziranega postopka.
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.
Slovenian: Predlagano besedilo: Klinične študije z radioaktivno označenim mazilom kažejo, da je sistemska absorpcija kalcipotriola in betametazona iz formulacije zdravila Daivobet mazilo manjša od enega odstotka odmerka (2,5 g), kadar se nanaša na normalno kožo (625 cm²) za 12 ur.
English: Section 4.3- Contraindications
Slovenian: Razdelek 4.3 - Kontraindikacije
English: The MAH proposed a harmonised text drafted accordingly to the one used in the MRP procedure with some amendments.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil osnutek usklajenega besedila, skladnega s tistim, ki je bilo uporabljeno med postopkom medsebojnega priznavanja, z nekaterimi spremembami.
English: In rats, tissue distribution studies with radiolabelled calcipotriol and betamethasone dipropionate, respectively, showed that the kidney and liver had the highest level of radioactivity.
Slovenian: Pri podganah so študije porazdelitve v tkivih z radiološko označenim kalcipotriolom in betametazondipropionatom pokazale, da je radioaktivnost najvišja v ledvicah in jetrih.
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.”
Slovenian: O neželenih učinkih, ki bi lahko bili povezani z dolgotrajno uporabo kortikosteroidov (npr. atrofija kože, folikulitis, depigmentacija, furunkel in purpura), je poročalo 4,8 odstotka bolnikov v skupini z zdravilom Daivobet mazilo, 2,8 odstotka v skupini z izmenjavanjem zdravila Daivobet mazilo/zdravila Daivonex ter 2,9 odstotka v skupni z zdravilom Daivonex.“
English: When lesions become secondarily infected, they should be treated with antimicrobiological therapy.
Slovenian: V primeru sekundarne okužbe lezij je potrebno zdravljenje s protimikrobnimi zdravili.
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.
Slovenian: Adrenalni odgovor na ACTH so določali z merjenjem serumske koncentracije kortizola pri bolnikih, ki so imeli močno razširjeno psoriazo, tako na lasišču kot po telesu, in so uporabljali do 106 g Daivobet gela v kombinaciji z Daivobet mazilom, na teden.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal naslednjo spremembo v poglavju 5.1: „V varnostni študiji, v kateri je sodelovalo 634 bolnikov s psoriazo, so proučevali nadaljnja zdravljenja z zdravilom Daivobet mazilo, ki se je po potrebi uporabljalo enkrat dnevno, samostojno ali izmenjaje z zdravilom Daivonex do 52 tednov, v primerjavi s samostojno uporabo zdravila Daivonex v trajanju 48 tednov po prvotnem zdravljenju z zdravilom Daivobet mazilo.
English: Unevaluated uses There is no experience for the use of Daivobet gel in guttate psoriasis.
Slovenian: Nepreskušeni načini uporabe Izkušenj o uporabi Daivobet gela pri gutatni psoriazi ni.
English: Less serious side effects caused by using betamethasone for a long time, include the following, and you should tell your doctor or nurse as soon as possible if you notice any of them - Thinning of the skin - Appearance of surface veins or stretch marks - Changes in hair growth - Red rash around the mouth (perioral dermatitis) - Skin rash with inflammation or swelling (allergic contact dermatitis) - Small white spots (colloid milia) - Depigmentation (lightening of skin colour).
Slovenian: Manj resni neželeni učinki, ki so posledica dolgotrajne uporabe betametazona, so naslednji, in če se pojavijo, morate čimprej obvestiti svojega zdravnika ali medicinsko sestro: - tanjšanje kože, - nastanek površinskih ven in strije, - spremembe pri rasti las, - rdeč izpuščaj okrog ust (perioralni dermatitis), - izpuščaj na koži z vnetjem in otekanjem kože (alergijski kontaktni dermatitis), - majhne bele pike (koloidna milia), - depigmentacija (posvetlitev barve kože).
English: There are no adequate data from the use of Daivobet gel in pregnant women.
Slovenian: Zadostnih podatkov o uporabi Daivobet gela med nosečnostjo ni.
English: Marketing Authorisation Holder and Manufacturer The Marketing Authorisation holder is: [See Annex I - To be completed nationally]
Slovenian: Imetnik dovoljenja za promet in izdelovalec Imetnik dovoljenja za promet: [glejte Prilogo I - izpolni država članica]
English: To improve clarity the CHMP endorsed the following: “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.
Slovenian: CHMP je za boljšo jasnost potrdil naslednje: „Odziv nadledvične žleze na adrenokortikotropni hormon (ACTH) je bil določen z merjenjem ravni kortizola v serumu pri bolnikih z obsežno psoriazo na lasišču in telesu, pri uporabi do 106 g kombinacije zdravila Daivobet gel in Daivobet mazilo ne teden.
English: In one MSs SPC there were no recommendations regarding the maximum daily dose (15g) or the percentage of the body surface area to be treated (30%).
Slovenian: V povzetku glavnih značilnosti zdravila v eni od držav članic ni bilo priporočila o največjem dnevnem odmerku (15 g) ali odstotku telesne površine, ki se lahko zdravi (30 odstotkov).
English: These reactions are usually mild and cover mainly various skin reactions with pruritus being the most common.
Slovenian: Učinki, med katerimi so večinoma različne reakcije na koži, najpogosteje pruritus, so običajno blagi.
English: Read all of this leaflet carefully before you start using this medicine.
Slovenian: Pred začetkom jemanja zdravila, natančno preberite navodilo za uporabo.
English: Daivobet gel contains a potent group III steroid and concurrent treatment with other steroids must be avoided.
Slovenian: Daivobet gel vsebuje močan steroid skupine III, zato se je potrebno izogibati sočasni uporabi drugih kortikosteroidov.
English: The use of Daivobet should be stopped as indicated by your doctor.
Slovenian: Z zdravljenjem z zdravilom Daivobet lahko prenehate v skladu z navodili vašega zdravnika.
English: Due to the formation of a depot in the skin elimination after dermal application is in order of days.
Slovenian: Ker se skladišči v koži, se po nanosu na kožo odstrani v dnevih.
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”.
Slovenian: 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“.
English: Effects on calcium metabolism
Slovenian: Učinki na presnavljanje kalcija
English: 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.
Slovenian: - Plastenko z morebitnimi ostanki gela zavrzite po 3 mesecih po prvem odprtju.
English: In one SPC the undesirable effects were not tabulated by MedDRA SOC (System Organ Class) as recommended in the EU SPC guideline.
Slovenian: 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.
English: 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.
Slovenian: CHMP je menil, da je na podlagi študij, izvedenih v podporo sočasnemu zdravljenju psoriaze telesa in lasišča s formulacijo gela in mazila, to dovoljeno.
English: HOW TO USE DAIVOBET
Slovenian: KAKO UPORABLJATI ZDRAVILO DAIVOBET
English: The systemic exposure to calcipotriol and betamethasone dipropionate from topically applied Daivobet gel is comparable to Daivobet ointment in rats and minipigs.
Slovenian: 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).
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).
Slovenian: 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).