FrancophonIA/ELRC3.0 huggingface dataset:
English: Other antipsoriatics for topical use, Calcipotriol, combinations.
Slovenian: Drugi antipsoriatiki za lokalno zdravljenje, kalcipotriol, kombinacije.
English: Pharmacotherapeutic group: Antipsoriatics.
Slovenian: Farmakoterapevtska skupina: Antipsoriatik.
English: There is experience with repeated courses of Daivobet up to 52 weeks.
Slovenian: Obstajajo izkušnje pri ponavljajočem se zdravljenju z zdravilom Daivobet do 52 tednov.
English: SPECIAL STORAGE CONDITIONS Do not refrigerate.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte v hladilniku.
English: Regarding precautions on the face and genitals the information “Long-term treatment of these parts of the body should be avoided” has been deleted because of the high risk local and systemic adverse reactions.
Slovenian: Podatek o previdnostnih ukrepih pri uporabi na obrazu in genitalijah „Izogibati se je treba dolgotrajnemu zdravljenju na teh delih telesa“ je bila izbrisan zaradi visokega tveganja pojavljanja lokalnih in sistemskih neželenih učinkov.
English: Industriparken 55 DK-2750 Ballerup Denmark
Slovenian: Industriparken 55 DK-2750 Ballerup Danska
English: Comparable adverse reactions were not observed in clinical studies.
Slovenian: V kliničnih študijah niso bili opaženi primerljivi neželeni učinki.
English: Concomitant skin infections
Slovenian: Sočasne okužbe kože
English: The CHMP found that there was no clear statement that this product should not be used there and endorsed the following harmonised wording: “Skin of the face and genitals are very sensitive to corticosteroids.
Slovenian: CHMP je odkril, da ni bilo jasne izjave o tem, da se zdravilo na teh predelih kože ne sme uporabljati, in predlagal naslednje usklajeno besedilo: „Koža na obrazu in genitalijah je zelo občutljiva za kortikosteroide.
English: week 8
Slovenian: 8. teden
English: In three MSs there was a warning “due to lack of experience it is necessary to be more careful with serious liver or kidney diseases”.
Slovenian: V treh državah članicah je bilo navedeno opozorilo „zaradi pomanjkanja izkušenj je pri uporabi pri hudih jetrnih ali ledvičnih boleznih potrebna posebna previdnost“.
English: The medicinal product should not be used in these areas.
Slovenian: Zdravila na teh predelih ne smemo uporabljati.
English: Studies in animals with glucocorticoids have shown reproductive toxicity (see section 5.3), but a number of epidemiological studies have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy.
Slovenian: Pri študijah na živalih so pri glukokortikoidih ugotovili vpliv na sposobnost razmnoževanja (glejte poglavje 5.3), vendar številne epidemiološke študije niso pokazale prirojenih anomalij pri otrocih mater, ki so med nosečnostjo uporabljale kortikosteroide.
English: It did appear that there was no experience of combination use of Daivobet and other topical treatments at the same site therefore the CHMP endorsed the following sentence:” There is no experience for the use of this medicinal product on the scalp.
Slovenian: Kazalo je, da ni izkušenj s kombinirano uporabo zdravila Daivobet in drugih topičnih zdravljenj na istem mestu, zato je CHMP predlagal naslednji stavek: „Z uporabo tega zdravila na lasišču ni nobenih izkušenj.
English: If you have used more Daivobet than you should Contact your doctor if you have used more than 15 grams in one day.
Slovenian: Če ste uporabili večji odmerek zdravila Daivobet kot bi smeli Obvestite svojega zdravnika, če ste uporabili več kot 15 g na dan.
English: The CHMP noted that the changes proposed by the MAH reflect the current safety experience.
Slovenian: CHMP je potrdil, da predlagane spremembe imetnika dovoljenja za promet z zdravilom odražajo trenutne varnostne izkušnje.
English: However, to comply with the latest version of the guidance on the SPC, the indication was amended to include adults as the intended to treat population.
Slovenian: Za zagotovitev skladnosti z najnovejšo različico smernic za povzetek glavnih značilnosti zdravila, je bila indikacija spremenjena tako, da vključuje odrasle kot ciljno populacijo zdravljenja.
English: This will avoid accidentally spreading the gel to other parts of your body (especially the face, mouth and eyes)
Slovenian: S tem boste preprečili nehoteni prenos gela na ostale dele telesa (predvsem na obraz, lasišče, usta in oči).
English: If you notice this, stop taking Daivobet and tell your doctor as soon as possible.
Slovenian: Če opazite ta neželeni učinek, prenehajte z uporabo zdravila Daivobet in čimprej obvestite svojega zdravnika.
English: These data do not contain any evidence that tapering the dose of Daivobet ointment will reduce the risk of rebound effects.
Slovenian: V teh podatkih ni dokazov, da bi zmanjšanje odmerka zdravila Daivobet mazilo zmanjšalo nevarnost pojavljanja odtegnitvenih učinkov.
English: The CHMP concluded that the MAH has justified not adding specific wording on rebound or on atrophy and has provided all requested information.
Slovenian: CHMP je zaključil, da je imetnik dovoljenja za promet z zdravilom utemeljil, zakaj ni dodal posebnega besedila o odtegnitvi ali atrofiji ter da je predložil vse zahtevane informacije.
English: Keep the bottle in the outer carton in order to protect from light.
Slovenian: Plastenko hranite v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: In several MS's SPC the warning for use on the face was “the ointment may/should/must not be used on the face region” rather than “to avoid application”.
Slovenian: V več državah članicah je bilo v povzetku glavnih značilnosti zdravila navedeno opozorilo za uporabo na obrazu „mazilo naj se ne/se ne sme uporabljati na predelih obraza“ namesto „izogibajte se uporabi“.
English: The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are followed.
Slovenian: Možnost nastanka hiperkalciemije je minimalna, če upoštevamo priporočila glede uporabe kalcipotriola.
English: Due to the thin stratum corneum of the face and genitals these areas are particularly susceptible to local and systemic adverse effects of corticosteroids.
Slovenian: Zaradi tanke rožene plasti pokožnice na obrazu in genitalijah so ta območja posebej dovzetna za lokalne in sistemske neželene učinke kortikosteroidov.
English: The information was therefore considered of relevance to the prescriber in recognising the safety profile of Daivobet ointment and in supporting precautionary measures that are included in other relevant sections of the SPC as Section 4.4.
Slovenian: Informacija je bila tako ocenjena kot pomembna za predpisovalca pri prepoznavanju varnostnega profila zdravila Daivobet mazilo in v podporo previdnostnim ukrepom, ki so vključeni v druga ustrezna poglavja povzetka glavnih značilnosti zdravila kot poglavje 4.4.
English: The CHMP agreed to this proposal.
Slovenian: CHMP je ta predlog potrdil.
English: The MAH agreed, however, that this is not an absolute contraindication and proposed to move it to section 4.4.
Slovenian: Imetnik dovoljenja za promet z zdravilom je menil, da to ni absolutna kontraindikacija ter predlagal premik te kontraindikacije v poglavje 4.4.
English: Within each frequency grouping, the adverse reactions are listed in order of decreasing seriousness.
Slovenian: Znotraj posamezne skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: The risk of rebound is well documented and the EU guidelines on the investigation of products for use in psoriasis recommend the investigation of rebound.
Slovenian: Nevarnost odtegnitve je dobro dokumentirana in smernice EU o proučevanju zdravil za uporabo pri zdravljenju psoriaze priporočajo raziskovanje odtegnitvenih učinkov.
English: Serious side effects known to be caused by calcipotriol - Allergic reactions with deep swelling of the face or other parts of the body such as the hands or feet.
Slovenian: Resni neželeni učinki, ki jih povzroča kalcipotriol - Alergične reakcije, ki vključujejo močno otekanje obraza in drugih delov telesa, kot so stopala in dlani.
English: Daivobet ointment in tubes of 3 g
Slovenian: Daivobet mazilo v tubah po 3 g
English: For further information about this medicine, contact the local representative of the Marketing Authorisation Holder [To be completed nationally]
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom: [izpolni država članica]
English: 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: Če je po tem obdobju potrebno nadaljevati ali ponovno uvesti zdravljenje, se lahko zdravljenje nadaljuje po zdravniškem pregledu in pod rednim zdravniškim nadzorom.
English: Treatment of more than 30 % of the body surface should be avoided (see section 4.2).
Slovenian: Zdravila se ne sme uporabljati na površini, večji od 30 % telesne površine (glejte poglavje 4.2).
English: This text was originally proposed by the MAH as part of a type II variation to update the SPC following the results of two non-clinical studies, a carcinogenicity study and a photo(co)carcinogenicity study.
Slovenian: To besedilo je prvotno predlagal imetnik dovoljenja za promet z zdravilom kot del sprememb tipa II za posodobitev povzetka glavnih značilnosti zdravila, potem ko so bili znani rezultati dveh nekliničnih študij, študije kancerogenosti in študije foto(ko)kancerogenosti.
English: The most current indication in the Member States (MSs) was “treatment of psoriasis vulgaris” and in other two MSs the indication was “combined treatment of psoriasis”.
Slovenian: Trenutna indikacija v državah članicah je bila „zdravljenje psoriaze vulgaris“, v drugih dveh državah članicah pa je bila indikacija „kombinirano zdravljenje psoriaze“.
English: A borderline decrease in cortisol response at 30 minutes post ACTH challenge was seen in 5 of 32 patients (15.6 %) after 4 weeks of treatment and in 2 of 11 patients (18.2 %) who continued treatment until 8 weeks.
Slovenian: Mejno znižanje koncentracije kortizola so, po 30 minutah po obremenitvi z ACTH, opazili pri 5 od 32 bolnikov (15,6 %) po 4 tednih zdravljenja in pri 2 od 11 bolnikov (18,2 %), ki so zdravljenje nadaljevali do 8 tednov.
English: When the ointment and body were assessed, other treatments were allowed for face and scalp.
Slovenian: Po ocenjevanju mazila in telesa so bila dovoljena druga zdravila za zdravljenje obraza in lasišča.
English: Signs of increased calcium in blood is bone pain, constipation, poor appetite, nausea and vomiting.
Slovenian: Znaki povišane ravni kalcija v krvi so: bolečine v kosteh, zaprtje, slab apetit, slabost in bruhanje.
English: These restrictions were introduced to avoid excessive exposure to calcipotriol and the possibility of vitamin D related adverse events (e.g. hypercalcaemia).
Slovenian: Te omejitve so bile dodane za preprečevanje prekomerne izpostavljenosti kalcipotriolu in neželenih učinkov, povezanih z vitaminom D (na primer hiperkalcemija).
English: Since there is no documented information on safety and efficacy for Daivobet ointment about guttate, erythrodermic, exfoliative and pustular psoriasis as none about patients with severe renal insufficiency or severe hepatic disorders, the MAH proposed to contraindicate Daivobet in these cases based on their exclusion from the clinical trial programme.
Slovenian: Ker ni dokumentiranih informacij glede varnosti in učinkovitosti zdravila Daivobet mazilo pri erupcijski, eritrodermični, eksfoliativni in pustularni psoriazi, kot tudi ne pri bolnikih s hudo ledvično insuficienco ali s hudimi jetrnimi motnjami, je imetnik dovoljenja za promet z zdravilom v teh primerih predlagal kontraindiciranje zdravila Daivobet na podlagi njihove izključenosti iz programov kliničnih preskušanj.
English: Secondary infection is a documented local adverse effect of treatment with topical corticosteroids.
Slovenian: Sekundarna okužba je dokumentiran lokalni neželeni učinek zdravljenja s topičnimi kortikosteroidi.
English: Section 4.6 - Pregnancy and lactation
Slovenian: Poglavje 4.6 - Nosečnost in dojenje
English: General disorders and administration site conditions Not known
Slovenian: Splošne težave in spremembe na mestu aplikacije Neznana
English: There are no data on the excretion of calcipotriol in breast milk.
Slovenian: Na voljo pa ni podatkov glede prehajanja kalcipotriola v materino mleko.
English: One SPC did not include: “Based on data from clinical trials and post market use the common undesirable effects are pruritus, rash and burning sensation of skin.
Slovenian: En povzetek glavnih značilnosti zdravila ni vključeval: „Na podlagi podatkov iz kliničnih preskušanj in uporabe po začetku trženja so pogosti neželeni učinki pruritus, izpuščaji in pekoč občutek na koži.
English: The clinical trial programme for Daivobet gel has so far included more than 4,700 patients of whom more than 2,100 were treated with Daivobet gel.
Slovenian: V program kliničnih preizkušanj z Daivobet gelom je bilo do sedaj vključeno več kot 4.700 bolnikov, od katerih jih je več kot 2.100 uporabljalo Daivobet gel.
English: Medical supervision should therefore continue in the post-treatment period.
Slovenian: Zato priporočamo zdravniško kontrolo tudi v času po končanem zdravljenju.
English: The CHMP accepted the inclusion of the above in the harmonised text.
Slovenian: CHMP je sprejel vključitev navedenega v usklajeno besedilo.
English: % of patients with absent or very mild disease
Slovenian: % bolnikov brez znakov bolezni ali z zelo blago boleznijo
English: Hypersensitivity to the active substances or to any of the excipients.
Slovenian: Preobčutljivost za zdravilni učinkovini ali katerokoli pomožno snov.
English: Like all medicines, Daivobet can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila, ima lahko tudi zdravilo Daivobet neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Calcipotriol (n=558)
Slovenian: kalcipotriol (n=558)
English: The CHMP commented that, as suggested from the MAH's wording, a patient using the maximum daily dose of 15 g will exceed the maximum weekly dose of 100 g, reaching 105 g. The MAH answered to this comment that some patients may need a daily dose of 15 g during the first few days of treatment, but since efficacy during the first week of treatment is high it would be reasonable to expect that patients would apply less treatment by the end of the week as the psoriasis lesions decrease in size and severity.
Slovenian: CHMP je pripomnil, da iz predlaganega besedila imetnika dovoljenja za promet z zdravilom izhaja, da bolniki, ki uporabljajo največji dnevni odmerek 15 g, prekoračijo največji tedenski odmerek 100 g in dosežejo 105 g. Imetnik dovoljenja za promet z zdravilom je odgovoril, da nekateri bolniki v prvih dneh zdravljenja morda potrebujejo dnevni odmerek 15 g, ker pa je učinkovitost v prvem tednu zdravljenja visoka, je razumno pričakovati, da bodo bolniki ob koncu tedna nanašali manjšo količino zdravila, saj se bo velikost in resnost lezij psoriaze zmanjšala.
English: Carton: Shelf life after first opening: 1 year Carton: Date opened: ____________________
Slovenian: Škatla: Rok uporabnosti po prvem odpiranju: 1 leto Škatla: Datum odpiranja: ____________________
English: What Daivobet is and what it is used for?
Slovenian: KAJ JE ZDRAVILO DAIVOBET IN ZA KAJ GA UPORABLJAMO
English: The text proposed by the MAH gave the clinician more specific information on the available pharmacokinetic data.
Slovenian: Predlagano besedilo imetnika dovoljenja za promet z zdravilom je zdravnikom ponudilo podrobnejše informacije o razpoložljivih farmakokinetičnih podatkih.
English: If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
English: Based on post marketing data, standard use of calcipotriol followed by average and standard UV-exposure does not seem to imply any special risk for patients using calcipotriol.
Slovenian: Podatki, pridobljeni po začetku trženja so pokazali, da povprečna in standardna izpostavljenost UV žarkom ob standardni uporabi kalcipotriola ne predstavlja nobenega posebnega tveganja za bolnike, ki uporabljajo kalcipotriol.
English: The efficacy and safety of Daivobet ointment has been investigated for periods longer than 4 weeks in study MCB 0102 INT.
Slovenian: Učinkovitost in varnost zdravila Daivobet mazilo je bila s študijo MCB 0102 INT raziskana v obdobjih, daljših od štirih tednov.
English: 6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje <in ravnanje z zdravilom> Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: In some MSs betamethasone dipropionate was described as a “glucocorticoid showing the general characteristics of the corticosteroids”.
Slovenian: V nekaterih državah članicah je bil betametazon dipropionat opisan kot „glukokortikoid, ki kaže splošne značilnosti kortikosteroidov“.
English: Pustular psoriasis
Slovenian: Redki pustulozna psoriaza
English: An almost clear, colourless to slightly off-white gel.
Slovenian: gel Skoraj bister, brezbarven do rahlo belkast gel.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Slovenian: PRILOGA I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: If it is necessary to continue or restart treatment after 4 weeks, treatment should be continued after medical review and under regular medical supervision.
Slovenian: Če je po 4 tednih potrebno nadaljevati ali ponovno uvesti zdravljenjese lahko zdravljenje nadaljuje po zdravniškem pregledu in pod rednim zdravniškim nadzorom.
English: Furthermore in four MSs the text “Skin of the face and genitals are very sensitive to corticosteroids.
Slovenian: Poleg tega je bilo v štirih državah članicah besedilo „Koža na obrazu in genitalijah je zelo občutljiva na kortikosteroide.
English: week 4 week 8
Slovenian: 4. teden 8. teden
English: Approximately 8 % of patients treated with Daivobet gel experienced a non-serious adverse reaction.
Slovenian: Pri približno 8 % bolnikov, ki so uporabljali Daivobet gel, so se pojavili neželeni učinki, ki pa niso bili resni.
English: Patients with psoriasis vulgaris often have lesions on the scalp as well as the body.
Slovenian: Pri bolnikih s psoriazo vulgaris se lezije pogosto pojavljajo tako na lasišču kot na telesu.
English: Tilt your head to make sure Daivobet does not run onto your face.
Slovenian: Nagnite glavo, da bi preprečili, da zdravilo Daivobet steče na obraz.
English: In all cases, the serum cortisol levels were normal at 60 minutes post ACTH challenge.
Slovenian: V vseh primerih so bile koncentracije kortizola normalne po preteku 60 minut po obremenitvi z ACTH.
English: Betamethasone is metabolised especially in the liver, but also in the kidneys to glucuronide and sulphate esters.
Slovenian: Betametazon se predvsem v jetrih, vendar tudi v ledvicah, presnavlja v glukoronid in sulfatne estre.
English: This can be serious, and you should contact your doctor immediately.
Slovenian: Stanje je lahko resno, zato morate o tem takoj obvestiti svojega zdravnika.
English: Rare (affects less than 1 in 1,000 people) - Pustular psoriasis may occur (a red area with yellowish pustules usually on the hands or feet).
Slovenian: Redki (pojavijo se pri manj kot pri 1 od 1.000 bolnikov) - Lahko se pojavi pustulozna psoriaza (rdeča koža z rumenkastimi mehurčki, največkrat na dlaneh in stopalih).
English: Application on large areas of damaged skin or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids (see section 4.8).
Slovenian: Izogibati se moramo uporabi zdravila na velikih predelih prizadete kože, na sluznicah ali v kožnih gubah, saj se s tem sistemska absorpcija kortikosteroidov poveča (glejte poglavje 4.8).
English: [To be completed nationally]
Slovenian: [izpolni država članica]
English: With regard to the contraindication in patients with severe renal and severe hepatic disorder, the MAH clarified that the contraindication has been included in the SPC based on its exclusion from the clinical trial programme, being not an absolute contraindication the information was removed from section 4.3 and the following was added in section 4.2: “The safety and efficacy of Daivobet ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je v zvezi s kontraindikacijo pri bolnikih s hudimi ledvičnimi in hudimi jetrnimi motnjami pojasnil, da bila je kontraindikacija vključena v povzetek glavnih značilnosti zdravila na podlagi izključitve iz programa kliničnih preskušanj, in ker ni bila absolutna kontraindikacija, je bil ta podatek izbrisan iz poglavja 4.3, v poglavju 4.2 pa je bilo dodano naslednje besedilo: „Varnost in učinkovitost zdravila Daivobet mazilo pri bolnikih s hudo ledvično insufienco ali hudimi jetrnimi motnjami nista bili ocenjeni“.
English: The CHMP agreed to the MAH proposal regarding the addition of Rebound effect as stated in section 4.4. and endorsed following: “Rebound effect after end of treatment has been reported but the frequency of this is not known”.
Slovenian: CHMP je potrdil predlog imetnika dovoljenja za promet z zdravilom o dodanih Odtegnitvenih učinkih, kot je navedeno v poglavju 4.4 in predlagal naslednje besedilo: „O odtegnitvenih učinkih po koncu zdravljenja so poročali, vendar njihova pogostnost ni znana.“
English: Therefore, during pregnancy, Daivobet gel should only be used when the potential benefit justifies the potential risk.
Slovenian: Daivobet gel se med nosečnostjo lahko uporablja le, če potencialne koristi opravičujejo morebitno tveganje.
English: Systemic reactions due to topical use of corticosteroids are rare in adults, however they can be severe.
Slovenian: Sistemski učinki so pri topikalni uporabi kortikosteroidov pri odraslih redki, so pa lahko hudi.
English: Skin of the face and genitals are very sensitive to corticosteroids.
Slovenian: Koža na obrazu in spolovilih je zelo občutljiva na kortikosteroide.
English: The percentage change in Psoriasis Severity and Area index (PASI) from baseline to week 4 and week 8 were secondary response criteria.
Slovenian: Sprememba deleža indeksa področja in resnosti psoriaze (Psoriasis Severity and Area index, PASI) od začetka zdravljenja do 4. oziroma 8. tedna je bila drugi kriterij za oceno odgovora.
English: 6.6 Special precautions for disposal and other handling No special requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje <in ravnanje z zdravilom> Ni posebnih zahtev.
English: In the same MS SPC there was also no mention of the increased risk of local and systemic corticosteroid undesirable effects in long term use which could lead to systemic adverse events that are as well known and documented.
Slovenian: V povzetku glavnih značilnost zdravila iste države članice prav tako ni bilo omenjeno povečano tveganje pojavljanja lokalnih in sistemskih neželenih učinkov zaradi dolgotrajne uporabe kortikosteroidov, ki lahko povzroči pojavljanje dobro znanih in dokumentiranih sistemskih neželenih učinkov.
English: No cases of skin atrophy were reported.
Slovenian: O primerih atrofije kože niso poročali.
English: In study MCB 0102 INT there was a trend towards greater efficacy and a lower incidence of adverse events reported in patients who remained on Daivobet ointment applied as required compared with patients who switched to other treatments.
Slovenian: V študiji MCB 0102 INT se je pokazal trend k večji učinkovitosti in manjši pojavnosti neželenih učinkov pri bolnikih, ki so nadaljevali zdravljenje z zdravilom Daivobet mazilo v skladu z navodili, v primerjavi z bolniki, ki so zdravljenje nadaljevali z drugim zdravilom.