FrancophonIA/ELRC3.0 huggingface dataset:
English: Daivobet ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults.
Slovenian: Daivobet mazilo se uporablja za zdravljenje kože, prizadete zaradi luskavice v plakih (psoriaze vulgaris) pri odraslih.
English: Excessive prolonged use can also cause your adrenal glands to stop working properly (the adrenal glands are found near the kidneys and produce hormones).
Slovenian: Če dlje časa uporabljate velike odmerke zdravila Daivobet, lahko pride do motenj v delovanju skorje nadledvične žleze (nadledvični žlezi se nahajata v bližini ledvic in izločata hormone).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [izpolni država članica]
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 area, other anti-psoriatic medicinal products administered systemically or with phototherapy”.
Slovenian: Zdravilo Daivobet mazilo za zdravljenje lezij psoriaze telesa se je uporabljalo v kombinaciji z zdravilom Daivobet gel za zdravljenje lezij psoriaze lasišča, vendar ni nobenih izkušenj s kombiniranjem zdravila Daivobet z drugimi topičnimi antipsoriatskimi zdravili na istih predelih, z drugimi antipsoriatičnimi zdravili, ki se uporabljajo sistemsko, ali s fototerapijo.“
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”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je menil, da bo vstavitev naslednjega besedila koristna: „Poročali so o bolniku z obsežno eritrodermično psoriazo, ki je zlorabljal zdravilo in se zdravil z 240 g zdravila Daivobet mazilo tedensko (kar ustreza dnevnemu odmerku okoli 34 g) v obdobju petih mesecev (največji priporočen dnevni odmerek je 15 g), po nenadni prekinitvi zdravljenja pa sta se pojavila Cushingov sindrom in pustularna psoriaza.“
English: If used on the scalp
Slovenian: Pri uporabi na lasišču
English: Due to the content of calcipotriol Daivobet ointment is contra-indicated in patients with known disorders of calcium metabolism.
Slovenian: Ker Daivobet mazilo vsebuje kalcipotriol, je kontraindicirano pri bolnikih z znanimi motnjami presnove kalcija.
English: Tube sizes: 3 (sample), 15, 30, 60, 100 and 120 g.
Slovenian: Velikosti tub: 3 g (vzorec), 15 g, 30 g, 60 g, 100 g in 120 g.
English: Approximately 1 in 12 people may experience side effects, but most of these are reactions at the site where the gel has been applied.
Slovenian: Neželeni stranski učinki se pojavijo približno pri 1 od 12 bolnikov, večinoma pa se pojavijo lokalno, na mestu nanosa gela.
English: Common side effects (affect less than 1 in 10 people) - Itching - Rash - Burning sensation.
Slovenian: Pogosti neželeni učinki (pojavijo se pri manj kot pri 1 od 10 bolnikov) - srbenje, - izpuščaj, - pekoč občutek v koži.
English: Due to the content of calcipotriol, Daivobet gel is contraindicated in patients with known disorders of calcium metabolism.
Slovenian: Ker Daivobet gel vsebuje kalcipotriol, je kontraindiciran pri bolnikih z znanimi motnjami presnove kalcija.
English: Topical treatment of scalp psoriasis in adults.
Slovenian: Topikalno zdravljenje psoriaze na lasišču pri odraslih.
English: Duration of treatment - Use the ointment once a day.
Slovenian: Trajanje zdravljenja - Uporabljajte mazilo enkrat na dan. Verjetno je bolj udobna njegova uporaba zvečer.
English: A randomised, double-blind long-term clinical study including 873 patients with scalp psoriasis of at least moderate severity (according to the IGA) investigated the use of Daivobet gel compared with calcipotriol in the gel vehicle.
Slovenian: V randomizirani, dvojno slepi, dolgotrajni klinični študiji, v kateri so ugotavljali uporabo Daivobet gela, v primerjavi s kalcipotriolom v gelu, je sodelovalo 873 bolnikov z vsaj zmerno psoriazo (merjeno po IGA).
English: This leaflet was last approved in {MM/YYYY}.
Slovenian: Navodilo je bilo odobreno: [{MM/YYYY}]
English: The following less serious side effects have been reported for Daivobet.
Slovenian: V zvezi z uporabo zdravila Daivobet so poročali o naslednjih manj resnih neželenih učinkih.
English: DAIVOBET GEL
Slovenian: ZDRAVILO DAIVOBET GEL
English: Dry skin
Slovenian: za uporabo na koži
English: Take special care with Daivobet
Slovenian: Bodite posebno pozorni pri uporabi zdravila Daivobet:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN POT(I) UPORABE [izpolni država članica]
English: Excessive prolonged use of Daivobet may also cause a problem with calcium in your blood, which usually normalises when discontinuing treatment.
Slovenian: Če dlje časa uporabljate velike odmerke zdravila Daivobet, lahko pride tudi do nenormalne koncentracije kalcija v krvi, ki pa se normalizira, če prenehate uporabljati zdravilo Daivobet.
English: In vitro data suggests that calcipotriol induces differentiation and suppresses proliferation of keratinocytes.
Slovenian: Kalcipotriol je analog vitamina D. In vitro podatki kažejo, da kalcipotriol povzroči diferenciacijo in zavira proliferacijo keratinocitov.
English: The following terminologies have been used in order to classify the frequencies of adverse reactions:
Slovenian: Pogostnost neželenih učinkov zdravila je razvrščena v naslednje skupine:
English: Daivobet gel SPC: “Topical treatment of scalp psoriasis in adults.
Slovenian: Povzetek glavnih značilnosti zdravila Daivobet gel: „Topično zdravljenje psoriaze na lasišču pri odraslih.
English: The CHMP believed relevant and adequate this recommendation for the harmonised SPC.
Slovenian: CHMP je bil prepričan, da je to priporočilo pomembno in ustrezno za usklajen povzetek glavnih značilnosti zdravila.
English: In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of Daivobet ointment.
Slovenian: - Za zagotovitev optimalnega učinka, takoj po uporabi zdravila Daivobet ni priporočljivo umivanje las.
English: What should I expect when I use Daivobet?
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO DAIVOBET
English: The MAH proposed a harmonised text in line to the DCP SPC with some amendments.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal usklajeno besedilo v skladu s povzetkom glavnih značilnosti zdravila iz decentraliziranega postopka z nekaterimi spremembami.
English: Betamethasone dipropionate (n=68)
Slovenian: betametazondipr opionat (n=68)
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”.
Slovenian: CHMP je podprl predlog imetnika dovoljenja za promet z zdravilom in z dodanimi podrobnostmi o primerih, kadar se steroidi ne smejo uporabljati, potrdil naslednje besedilo: „Zaradi vsebnosti koritkosteroidov je zdravilo Daivobet mazilo kontraindicirano v primeru: Virusne (na primer herpes ali norice) lezije kože, glivične ali bakterijske okužbe kože, parazitne okužbe, pojavi na koži zaradi tuberkuloze ali sifilisa, perioralni dermatitis, atrofična koža, striae atrophicae, šibkost kožnih ven, ihtioza, akne vulgaris, akne rozacea, rozacea, razjede, rane, perianalni in genitalni pruritus“.
English: The MAH proposed to add some detailed information from these mentioned studies in the harmonized SPC.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal dopolnitev usklajenega povzetka glavnih značilnosti zdravila z nekaterimi podrobnimi informacijami iz omenjenih študij.
English: Excessive prolonged use of Daivobet may cause a problem with calcium in your blood, which usually normalises when discontinuing treatment.
Slovenian: Če dlje časa uporabljate velike odmerke zdravila Daivobet, lahko pride do nenormalne koncentracije kalcija v krvi, ki pa se normalizira, če prenehate uporabljati zdravilo Daivobet.
English: 100 g 120 g
Slovenian: 120 g
English: INFORMATION IN BRAILLE Carton for 15 g, 30 g, 60 g, 100 g or 120 g pack sizes: [To be completed nationally] Daivobet 50 micrograms/0.5 mg/g ointment
Slovenian: PODATKI V BRAILLOVI PISAVI Škatla iz kartona za pakiranja v velikosti 15 g, 30 g, 60 g, 100 g ali 120 g: [izpolni država članica]
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET [izpolni država članica]
English: Discontinuation of treatment and Long term use In one MS there was no reference to rebound effects when discontinuing treatment with corticosteroids.
Slovenian: V eni državi članici ni bilo navodil glede odtegnitvenih učinkov pri prekinitvi zdravljenja s kortikosteroidi.
English: This description is more general than in the MRP SPC: “Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive properties, however, without curing the underlying condition”.
Slovenian: Ta opis je bolj splošen kot besedilo v povzetku glavnih značilnosti zdravila iz postopka medsebojnega priznavanja: „Podobno kot drugi topični kortikosteroidi ima betametazon dipropionat protivnetne, antipruristične,vazokonstrikcijske in imunosupresivne lastnosti, vendar pri tem ne zdravi osnovne bolezni.“ Potrditev predlaganega besedila bi zdravnikom zagotovila dodatne uporabne informacije o posebnem delovanju kortikosteroidnega sestavnega dela zdravila Daivobet mazilo.
English: Paraffin, liquid, polyoxypropylene-15 stearyl ether, hydrogenated castor oil, butylhydroxytoluene (E321), all-rac-α-tocopherol.
Slovenian: Pomožne snovi: tekoči parafin, polioksipropilen-15-stearil eter, hidrogenirano ricinusovo olje, butilhidroksitoluen (E321), vseracemni α-tokoferol.
English: Pack sizes: 15, 30, 60, 100 and 120 g.
Slovenian: Velikosti pakiranj: 15 g, 30 g, 60 g, 100 g in 120 g.
English: - Cataracts (signs are cloudy and foggy vision, difficulty seeing at night and sensitivity to light) or an increase in pressure inside the eye (signs are eye pain, red eye, decreased or cloudy vision) - Infections (because your immune system which fights infections may be suppressed or weakened) - Impact on the metabolic control of diabetes mellitus (if you have diabetes you may experience fluctuations in the blood glucose levels).
Slovenian: Če se pojavi katerikoli resen neželen učinek, takoj obvestite svojega zdravnika: - motnje delovanja skorje nadledvične žleze; Znaki so utrujenost, depresija, tesnoba, - siva mrena (znaki so: zamegljen vid, slabovidnost v temi, občutljivost na svetlobo) ali zvišan očesni tlak (znaki so: bolečina v očesu, rdečina očesa, poslabšanje vida ali zamegljen vid), - okužbe (ker lahko pride do oslabitve delovanja vašega imunskega sistema, ki se bori proti okužbam), - vpliv na nadzor sladkorne bolezni (če imate sladkorno bolezen, boste morda opazili nihanje ravni glukoze v krvi).
English: This is in accordance with the DCP approved Daivobet gel SPC.
Slovenian: To je usklajeno s povzetkom glavnih značilnosti zdravila Daivobet gel, ki je bilo odobreno z decentraliziranim postopkom.
English: HOW TO STORE DAIVOBET
Slovenian: SHRANJEVANJE ZDRAVILA DAIVOBET
English: Shake the bottle before use.
Slovenian: Pred uporabo pretresite plastenko.
English: What Daivobet contains
Slovenian: Kaj vsebuje zdravilo Daivobet:
English: These reactions are usually mild and cover mainly various skin reactions like rash, pruritus and burning sensation.
Slovenian: Učinki, med katerimi so večinoma različne reakcije na koži, kot so izpuščaj, pruritus in pekoč občutek v koži, so običajno blagi.
English: In order to achieve optimal effect, it is not recommended to take a shower or bath, or to wash the hair in case of scalp application, immediately after application of Daivobet gel.
Slovenian: - Za doseganje optimalnega učinka prhanje ali kopanje v primeru nanosa na lasišče ni priporočljivo takoj po nanosu Daivobet gela.
English: - Keep this leaflet.
Slovenian: - Mazilo iztisnite na čist prst.
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 antipsoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy.
Slovenian: Daivobet mazilo za zdravljenje psoriaznih lezij na koži po telesu je bilo uporabljeno v kombinaciji z Daivobet gelom za zdravljenje psoriaznih lezij na lasišču, vendar izkušenj s kombinacijo Daivobeta in drugih topikalnih izdelkov za zdravljenje psoriaze na istem predelu, sočasno sistemsko uporabo drugih zdravil za zdravljenje psoriaze oziroma sočasno uporabo fototerapije ni na voljo.
English: Caution should be exercised when prescribing Daivobet ointment to women who breast feed.
Slovenian: Pri predpisovanju Daivobet mazila doječim materam, je potrebna previdnost.
English: Liquid paraffin, all-rac-α-tocopherol, polyoxypropylene-15 stearyl ether, white soft paraffin
Slovenian: Pomožne snovi: tekoči parafin, vseracemni α-tokoferol, polioksipropilen-15-stearil eter, beli mehki parafin
English: In one MS SPC there was the contraindication in patients with disorders of calcium metabolism.
Slovenian: Povzetek glavnih značilnosti zdravila v eni državi članici je vključevalo kontraindikacijo pri bolnikih z motnjami pri presnavljanju kalcija.
English: Bottle text: Lot/EXP - see the bottom of the bottle.
Slovenian: Besedilo na škatli: Serija/Uporabno do: Glejte spodnjo stran škatle.
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IMETNIK DOVOLJENJA ZA PROMET [glejte Prilogo I - izpolni država članica]
English: BATCH NUMBER Bottle text: Lot/EXP - see the bottom of the bottle.
Slovenian: Besedilo na plastenki: Serija/Uporabno do: Glejte dno plastenke.
English: - Do not bandage, tightly cover or wrap the treated skin area - Wash your hands well after using Daivobet.
Slovenian: - Po uporabi zdravila Daivobet si dobro umijte roke.
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).
Slovenian: Zdravilo Daivobet vsebuje močan steroid, zato ga NE uporabljajte na koži, ki je prizadeta zaradi: - virusne okužbe (npr. herpes na ustih ali obrazu ali norice), - glivične okužbe kože (npr. atletsko stopalo ali tinea - okrogle luščeče glivične spremembe na koži), - bakterijske okužbe, - okužbe s paraziti (npr. garje), - tuberkuloze (TB) ali sifilisa, - perioralnega dermatitisa (rdeč izpuščaj okrog ust), - stanjšanja kože; če imate občutljive kožne vene, ki se hitro poškodujejo, ali strije, - ihtioze (suha koža z luskami, ribja koža), - aken (mozolji), - rozacee (hudo pordevanje in rdečina kože na obrazu),
English: Polyoxypropylene-15 stearyl ether Castor oil, hydrogenated Butylhydroxytoluene (E321) All-rac-α-tocopherol
Slovenian: 6.1 Seznam pomožnih snovi tekoči parafin polioksipropilen-15-stearil eter hidrogenirano ricinusovo olje butilhidroksitoluen (E321) vseracemni α-tokoferol
English: Topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults”.
Slovenian: Topično zdravljenje blage do zmerne psoriaze vulgaris v plakih , ki se ne pojavlja na lasišču, pri odraslih“.
English: Furthermore, since Daivobet gel is an extension to Daivobet ointment and there were some differences in the SPCs.
Slovenian: Zdravilo Daivobet gel je dodatek zdravilu Daivobet mazilo, v njunih povzetkih glavnih značilnosti zdravila pa so se pojavljale razlike.
English: Folliculitis
Slovenian: mazilo
English: Statistically significantly less effective than Daivobet gel (P<0.05)
Slovenian: Statistično značilno manj učinkovit kot Daivobet gel (P<0,05)
English: Duration of treatment - Use the gel once a day.
Slovenian: Trajanje zdravljenja - Uporabljajte gel enkrat na dan. Verjetno je bolj udobna njegova uporaba zvečer.
English: Application to psoriasis plaques and under occlusive dressings may skin (625 cm increase the absorption of topical corticosteroids.
Slovenian: Uporaba na prizadeti koži (psoriazni plaki) ali pod okluzivnimi povoji lahko poveča absorpcijo topikalnih kortikosteroidov.
English: EXP Shelf life after first opening: 1 year
Slovenian: Rok uporabnosti po prvem odpiranju: 1 leto
English: Burning sensation of skin
Slovenian: Spremljajoče okužbe kože
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En g gela vsebuje 50 mikrogramov kalcipotriola (v obliki monohidrata) in 0,5 mg betametazona (v obliki dipropionata).
English: Vitamin D related adverse events resulting from extensive exposure to calcipotriol have been reported in a few cases in the literature.
Slovenian: V literaturi je navedenih nekaj primerov pojavljanja neželenih učinkov, povezanih z vitaminom D, zaradi prekomerne izpostavljenosti kalcipotriolu.
English: 1 Statistically significantly less effective than Daivobet gel (P<0.05)
Slovenian: 1 Statistično značilno manj učinkovit kot Daivobet gel (P<0,05)
English: All-rac-α-tocopherol
Slovenian: - butilhidroksitoluen (E321) - vseracemni α-tokoferol
English: Calcipotriol
Slovenian: Kalcipotriol
English: 1 Statistically significantly less effective than Daivobet gel (P<0.001)
Slovenian: 1 Statistično značilno manj učinkovit kot Daivobet gel (P<0,001)
English: The other ingredients are: - liquid paraffin - all-rac-α-tocopherol - polyoxypropylene-15-stearyl ether - white soft paraffin.
Slovenian: Pomožne snovi so: - tekoči parafin - vseracemni α-tokoferol - polioksipropilen-15-stearil eter - beli mehki parafin
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.
Slovenian: Ker Daivobet gel vsebuje kortikosteroid, je prav tako kontraindiciran pri naslednjih obolenjih: virusne (npr. herpes ali varicella) lezije kože ter glivične in bakterijske okužbe, okužbe s paraziti, spremembe na koži zaradi tuberkuloze ali sifilisa, perioralni dermatitis, atrofija kože, strije, krhke vene v koži, ihtioza, akne vulgaris, akne rozacea, rozacea, razjede, rane, perianalni ali genitalni pruritus.
English: Ointment
Slovenian: Jakost
English: Statistically significantly less effective than Daivobet gel (P<0.001)
Slovenian: Statistično značilno manj učinkovit kot Daivobet gel (P<0,001)
English: 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.
Slovenian: Ker Daivobet mazilo vsebuje kortikosteroid, je prav tako kontraindicirano pri naslednjih obolenjih: virusne (npr. herpes ali varicella) lezije kože ter glivične in bakterijske okužbe, okužbe s paraziti, spremembe na koži zaradi tuberkuloze ali sifilisa, perioralni dermatitis, atrofija kože, strije, krhke vene v koži, ihtioza, akne vulgaris, akne rozacea, rozacea, razjede, rane, perianalni ali genitalni pruritus.
English: PHARMACEUTICAL FORM Ointment.
Slovenian: FARMACEVTSKA OBLIKA mazilo
English: Daivobet mast
Slovenian: ZDRAVILO DAIVOBET MAZILO
English: The wording in the national SPCs of a number of MSs largely reflected the wording in MRP SPC.
Slovenian: Besedila v nacionalnih povzetkih glavnih značilnosti zdravila v številnih državah članicah v veliki meri odražajo besedilo iz postopka medsebojnega priznavanja.
English: Uncommon (affects less than 1 in 100 people) - Worsening of your psoriasis.
Slovenian: Občasni (pojavijo se pri manj kot pri 1 od 100 bolnikov) - Poslabšanje luskavice; če pride do poslabšanja bolezni, čimprej obvestite svojega zdravnika.
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.
Slovenian: Pri 34 bolnikih, ki so 4 ali 8 tednov uporabljali Daivobet gel in Daivobet mazilo za močno izraženo psoriazo, tako na lasišču kot po telesu, je bila koncentracija kalcipotriola in betametazondipropionata v vseh vzorcih krvi prenizka, da bi jo bilo mogoče izmeriti.
English: There is no experience for the use of this medicinal product on the scalp.
Slovenian: Drugo sočasno zdravljenje in izpostavljanje UV-žarkom Izkušnje o uporabi tega zdravila na lasišču niso na voljo.
English: In conclusion, the CHMP endorsed the following wording under this section: Daivobet ointment SPC: “Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy in adults”.
Slovenian: Povzetek glavnih značilnosti zdravila Daivobet mazilo: „Topično zdravljenje stabilne psoriaze v plakih, ki se odziva na topično zdravljenje pri odraslih“.
English: - Keep out of the reach and sight of children - Do not use Daivobet after the expiry date, which is stated on the label after EXP.
Slovenian: - Zdravila Daivobet ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki poleg oznake »Uporabno do:«.
English: Caution should be exercised when prescribing Daivobet gel to women who breast-feed.
Slovenian: Pri predpisovanju Daivobet gela doječim materam, je potrebna previdnost.
English: However, when the treatment is stopped, the levels return to normal.
Slovenian: Po prekinitvi zdravljenja se raven kalcija normalizira.
English: No major updates to the Daivobet gel SPC according to the adoption of Daivobet ointment SPC (MRP) were required.
Slovenian: V povzetku glavnih značilnosti zdravila Daivobet gel v skladu s sprejetim povzetkom glavnih značilnosti zdravila Daivobet mazilo (postopek medsebojnega priznavanja) niso potrebne večje posodobitve.
English: Exacerbation of psoriasis Burning sensation of skin Skin pain or irritation Folliculitis
Slovenian: Občasni poslabšanje psoriaze bolečine in draženje kože dermatitis eritem folikulitis spremembe pigmentacije na mestu nanosa
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.
Slovenian: V program kliničnih preizkušanj z Daivobet mazilom je bilo do sedaj vključeno več kot 2.500 bolnikov.