FrancophonIA/ELRC3.0 huggingface dataset:
English: As systemic exposure is low with tacrolimus ointment, the high binding of tacrolimus (>98.8%) to plasma proteins is considered not to be clinically relevant.
Slovenian: Porazdelitev Sistemska izpostavljenost je med uporabo mazila s takrolimusom majhna, zato velika vezava takrolimusa (> 98,8%) na beljakovine v plazmi ne velja za klinično pomembno.
English: Patients may be at an increased risk of folliculitis, acne and herpes viral infections.
Slovenian: Bolnike lahko bolj ogrožajo folikulitis, akne in herpes virusne okužbe.
English: Protopic ointment should not be applied under occlusion because this method of administration has not been studied in patients (see section 4.4).
Slovenian: Zdravila Protopic mazilo se ne sme uporabiti pod okluzijo, kajti takšen način uporabe ni bil preskušan na bolnikih (glejte poglavje 4.4).
English: Patients with atopic dermatitis are predisposed to superficial skin infections.
Slovenian: Bolniki z atopičnim dermatitisom so nagnjeni k površinskim okužbam kože.
English: Thereafter, patients are considered suitable for maintenance treatment (see below).
Slovenian: Potem se pri bolnikih lahko začne z vzdrževalnim zdravljenjem (glejte spodaj).
English: Contents of the pack and other information What Protopic contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Protopic
English: You may use moisturising creams and lotions during treatment with Protopic but these products should not be used within two hours of applying Protopic.
Slovenian: Med zdravljenjem z zdravilom Protopic lahko uporabljate vlažilne kreme in losjone, vendar teh izdelkov ne smete nanesti v razmiku manj kot dve uri od uporabe zdravila Protopic.
English: Improvement ≥ 90% in Physician's Global Evaluation
Slovenian: Izboljšanje za ≥ 90% po zdravniški celotni oceni
English: • Protopic may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees.
Slovenian: • Zdravilo Protopic lahko uporabljate na večini delov telesa, tudi na obrazu, vratu in v komolčnih in kolenskih pregibih.
English: The overall incidence of adverse events tended to decrease as the study progressed for all patients independent of age.
Slovenian: Celotna incidenca neželenih učinkov se je med potekom raziskave zmanjševala pri vseh bolnikih, ne glede na starost.
English: Protopic treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Slovenian: Zdravljenje z zdravilom Protopic morajo uvesti zdravniki, ki imajo izkušnje z diagnosticiranjem in zdravljenjem atopičnega dermatitisa.
English: In animals, tacrolimus ointment suppressed inflammatory reactions in experimental and spontaneous dermatitis models that resemble human atopic dermatitis.
Slovenian: Pri živalih je mazilo s takrolimusom zavrlo vnetno reakcijo v modelih eksperimentalnega in spontanega dermatitisa, podobnih atopičnemu dermatitisu pri človeku.
English: The use of Protopic at the same time as other preparations to be used on the skin or while taking oral corticosteroids (e.g. cortisone) or medicines which affect the immune system has not been studied.
Slovenian: Hkratna uporaba zdravila Protopic z drugimi pripravki, ki se uporabljajo na koži, in med jemanjem peroralnih kortikosteroidov (npr. kortizona) ali zdravil, ki vplivajo na imunski sistem, ni raziskana.
English: Based on changes from baseline in EASI score and body surface area affected, patients regardless of age had improvement in their atopic dermatitis at all subsequent time points.
Slovenian: Na podlagi sprememb seštevka EASI v primerjavi z izhodiščem in na podlagi sprememb prizadetega območja telesne površine se je v vseh zaporednih časovnih točkah atopični dermatitis izboljšal vsem bolnikom, ne glede na starost.
English: Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri sistemski uporabi (glejte poglavje 5.3).
English: There is no experience with concomitant use of systemic steroids or immunosuppressive agents.
Slovenian: Izkušenj s sočasno uporabo sistemskih steroidov ali imunosupresivov ni.
English: In both adults and children with an average of 50% body surface area treated, systemic exposure (i.e. AUC) of tacrolimus from Protopic is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
Slovenian: Tako pri odraslih kot pri otrocih s povprečno 50% zdravljene telesne površine je sistemska izpostavljenost (tj. AUC) takrolimusa iz zdravila Protopic približno 30-krat manjša kot po peroralnih imunosupresivnih odmerkih pri bolnikih s presajenimi ledvicami ali jetri.
English: Lymphadenopathy present at initiation of therapy should be investigated and kept under review.
Slovenian: Limfadenopatijo, ki je prisotna že ob začetku zdravljenja, je treba raziskati in spremljati.
English: Generally, improvement is seen within one week of starting treatment.
Slovenian: Običajno je izboljšanje vidno v prvem tednu po začetku zdravljenja.
English: Long-term topical treatment of rats with tacrolimus led to systemic toxicity including alterations of kidneys, pancreas, eyes and nervous system.
Slovenian: Dolgoročno lokalno zdravljenje podgan s takrolimusom je povzročilo sistemske toksične učinke, vključno s spremembami na ledvicah, pankreasu, očeh in živčevju.
English: Afterwards the frequency of application should be reduced to once a day until clearance of the lesion (see section 4.4).
Slovenian: Potem je treba pogostnost uporabe zmanjšati na enkrat na dan in zdravilo uporabljati, dokler spremembe ne izginejo (glejte poglavje 4.4).
English: Butylhydroxytoluene (E321) 15 micrograms/g ointment.
Slovenian: Butilhidroksitoluen (E321) 15 mikrogramov/g mazila.
English: Patients, particularly paediatric patients should be continuously evaluated during treatment with Protopic with respect to the response to treatment and the continuing need for treatment.
Slovenian: Med zdravljenjem z zdravilom Protopic je potrebno bolnike, predvsem pediatrične, nenehno spremljati glede odziva na zdravljenje in stalne potrebe po zdravljenju.
English: The three most common adverse events reported were flu-like symptoms (cold, common cold, influenza, upper respiratory infection, etc.), pruritus and skin burning.
Slovenian: Trije najpogosteje opisani neželeni učinki so bili gripi podobni simptomi (prehlad, nahod, influenca, okužba zgornjih dihal itn.), srbenje in pekoč občutek na koži.
English: Mechanism of action and pharmacodynamic effects The mechanism of action of tacrolimus in atopic dermatitis is not fully understood.
Slovenian: Mehanizem delovanja in farmakodinamični učinki Mehanizem delovanja takrolimusa pri atopičnem dermatitisu ni povsem jasen.
English: The development of any new change different from previous eczema within a treated area should be reviewed by the physician.
Slovenian: Če se znotraj zdravljenega področja pojavi kakršnakoli sprememba, ki se razlikuje od prejšnjega ekcema, mora takšno spremembo pregledati zdravnik.
English: In the fourth trial, approximately 800 patients (aged ≥2 years) received 0.1% tacrolimus ointment intermittently or continuously in an open-label, long-term safety study for up to four years, with 300 patients receiving treatment for at least three years and 79 patients receiving treatment for a minimum of 42 months.
Slovenian: V četrti študiji, odprti, dolgoročni raziskavi varnosti, je približno 800 bolnikov (starih ≥ 2 leti) do štiri leta intermitentno ali stalno dobivalo 0,1-% mazilo s takrolimusom; 300 bolnikov je bilo zdravljenih vsaj tri leta, 79 bolnikov pa je zdravljenje dobivalo najmanj 42 mesecev.
English: After 12 months treatment, a review of the patient`s condition should be conducted by the physician and a decision taken whether to continue maintenance treatment in the absence of safety data for maintenance treatment beyond 12 months.
Slovenian: Po 12 mesecih mora zdravnik znova pregledati bolnikovo stanje in se odločiti, ali naj se vzdrževalno zdravljenje nadaljuje, kljub pomanjkanju podatkov o varnosti več kot 12-mesečnega vzdrževalnega zdravljenja.
English: • Wash your hands after applying Protopic unless your hands are also being treated.
Slovenian: • Po nanosu zdravila Protopic si umijte roke, razen če si zdravite tudi roke.
English: • If you have a cutaneous Graft Versus Host Disease (an immune reaction of the skin which is a common complication in patients who have undergone a bone marrow transplant).
Slovenian: • Če imate kožno obliko bolezni presadka proti gostitelju (to je imunski odziv na koži, ki je pogost zaplet pri bolnikih po presaditvi kostnega mozga);
English: After 12 months this evaluation should include suspension of Protopic treatment in paediatric patients (see section 4.2).
Slovenian: Po 12 mesecih naj ta ocena pri pediatričnih bolnikih vključuje prekinitev zdravljenja z zdravilom Protopic (glejte poglavje 4.2).
English: No adverse events previously unreported in shorter duration and/or previous studies were observed in this long-term study.
Slovenian: Med to dolgoročno raziskavo niso zabeležili neželenih učinkov, ki ne bi bili že pred tem opisani v kratkotrajnejših in/ali prejšnjih raziskavah.
English: • If you have swollen lymph nodes at initiation of treatment.
Slovenian: • Če imate otekle bezgavke na začetku zdravljenja.
English: Pruritus decreased over time in the tacrolimus groups but not in the hydrocortisone group.
Slovenian: Srbenje se je v skupinah s takrolimusom sčasoma zmanjšalo, v skupini s hidrokortizonom pa ne.
English: The primary endpoint of this study was the response rate to vaccination, defined as the percentage of patients with a serum bactericidal antibody (SBA) titre ≥8 at the week 5 visit.
Slovenian: Primarni opazovani dogodek te študije je bila stopnja odziva na cepljenje, ki je opredeljena kot odstotek bolnikov s titrom serumskih baktericidnih protiteles (SBA) ≥ 8 ob študijskem kontrolnem pregledu v 5. tednu.
English: 217 days
Slovenian: 217 dni
English: Median number of DEs adjusted for time at risk (% of patients without any DE periods)
Slovenian: korigirano za čas ogroženosti (% bolnikov, pri katerih ni prišlo do PB)
English: Acne*
Slovenian: Akne*
English: The pharmacokinetics of tacrolimus after topical application are similar to those reported in adults, with minimal systemic exposure and no evidence of accumulation (see above).
Slovenian: Farmakokinetika takrolimusa po lokalni uporabi je primerljiva s tisto, ki je opisana za odrasle, in sicer minimalna sistemska izpostavljenost ter odsotnost znakov kopičenja (glejte zgoraj).
English: • Do not cover the skin being treated with bandages or wraps.
Slovenian: • Zdravljene kože ne prekrivajte s povoji ali kako drugače.
English: What you need to know before you use Protopic Do not use Protopic
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Protopic Ne uporabljajte zdravila Protopic
English: improvement in mEASI (Primary Endpoint)§§
Slovenian: izboljšanjem mEASI (primarni opazovani dogodek)§§
English: Each affected region of the skin should be treated with Protopic until lesions are cleared, almost cleared or mildly affected.
Slovenian: Vsak prizadeti predel kože je treba zdraviti z zdravilom Protopic, dokler spremembe skoraj ali v celoti ne izginejo oziroma dokler je koža samo še rahlo prizadeta.
English: If symptoms recur, twice daily treatment with Protopic 0.1% should be restarted.
Slovenian: Če se simptomi znova pojavijo, je ponovno treba začeti zdravljenje z zdravilom Protopic 0,1% mazilo dvakrat na dan.
English: Afterwards the ointment should be used once a day on each affected region of the skin until the eczema has gone away.
Slovenian: V nadaljevanju pa je treba mazilo na prizadetih predelih kože uporabljati enkrat na dan, dokler ekcem ne izgine.
English: Mutagenicity In vitro and in vivo tests did not indicate a genotoxic potential of tacrolimus.
Slovenian: Mutagenost Preizkusi in vitro in in vivo niso pokazali, da bi imel takrolimus genotoksičen potencial.
English: Following twice-weekly treatment application site infections have been reported in children and adults.
Slovenian: Pri režimu zdravljenja dvakrat na teden so poročali o okužbah na mestu uporabe pri otrocih in odraslih.
English: Median mEASI as Percentage of Baseline mean AUC (Primary Endpoint)§
Slovenian: Mediana mEASI kot odstotek izhodiščne povprečne AUC (primarni opazovani dogodek)§
English: The incidence of local skin burning was higher in the tacrolimus treatment groups than in the hydrocortisone group.
Slovenian: Incidenca lokalnega pekočega občutka na koži je bila v skupinah s takrolimusom večja kot v skupini s hidrokortizonom.
English: *The adverse reaction has been reported during post-marketing experience Post-marketing
Slovenian: * O neželenem učinku so poročali med izkušnjami po začetku trženja zdravila Po začetku trženja zdravila
English: How to use Protopic
Slovenian: Kako uporabljati zdravilo Protopic
English: • If your doctor tells you to use Protopic twice weekly to keep your atopic dermatitis cleared, your condition should be reviewed by your doctor at least every 12 months, even if it remains under control.
Slovenian: • Če vam je zdravnik predpisal zdravilo Protopic za vzdrževalno zdravljenje atopičnega dermatitisa, in sicer dvakrat tedensko, vas mora vsaj na vsakih 12 mesecev uporabe zdravila znova pregledati, tudi če se bolezen ne poslabša.
English: Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap.
Slovenian: Laminatna tuba z notranjo prevleko iz polietilena majhne gostote, opremljena z belo polipropilensko navojno zaporko.
English: Patients with atopic dermatitis treated with Protopic have not been found to have significant systemic tacrolimus levels.
Slovenian: Pri bolnikih z atopičnim dermatitisom, ki dobivajo zdravilo Protopic, niso ugotovili pomembne sistemske koncentracije takrolimusa.
English: Exposure of the skin to sunlight should be minimised and the use of ultraviolet (UV) light from a solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use of Protopic ointment (see section 5.3).
Slovenian: Izpostavljenost kože sončni svetlobi je treba omejiti na najmanjšo mero; med zdravljenjem z zdravilom Protopic mazilo se je treba izogibati uporabi ultravijolične (UV) svetlobe v solarijih in zdravljenju z UVB ali UVA v kombinaciji s psoraleni (PUVA) (glejte poglavje 5.3).
English: Do not apply the ointment to infected lesions.
Slovenian: Mazila ne nanašajte na okužene predele;
English: Occlusive dressings are not recommended.
Slovenian: Okluzivno povijanje ni priporočljivo.
English: If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible.
Slovenian: Če pomotoma zaužijete mazilo, se čim prej posvetujte z zdravnikom ali farmacevtom.
English: The use of Protopic ointment under occlusion has not been studied in patients.
Slovenian: Uporaba zdravila Protopic mazilo pod okluzijo pri bolnikih ni raziskana.
English: 36 days
Slovenian: 36 dni
English: Protopic is a white to slightly yellowish ointment.
Slovenian: Zdravilo Protopic je belo do rahlo rumenkasto mazilo.
English: In a photocarcinogenicity study, albino hairless mice were chronically treated with tacrolimus ointment and UV radiation.
Slovenian: V raziskavi fotokancerogenosti so brezdlakave albine miši kronično zdravili z mazilom s takrolimusom in UV-obsevanjem.
English: • If you have an inherited skin barrier disease such as Netherton's syndrome, lamellar ichthyosis (extensive scaling of the skin due to a thickening of the outer layer of the skin), or if you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire skin).
Slovenian: • Če imate prirojeno bolezen kožne pregrade, kot je na primer Nethertonov sindrom, lamelarna ihtioza (zadebeljena zunanja plast kože, ki se intenzivno lušči) ali pa če imate generalizirano eritrodermijo (vnetna pordelost in luščenje kože po celem telesu);
English: Topical corticosteroid regimen§ (N=485)
Slovenian: Lokalno zdravljenje s kortikosteroidom§ (N=485)
English: Sensation of warmth, pain, paraesthesia and rash at the site of application were also commonly observed.
Slovenian: Pogosto so opažali tudi občutek toplote, bolečine, parestezije in izpuščaj na mestu uporabe.
English: While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known.
Slovenian: Znani so naslednji izsledki, katerih klinični pomen pri atopičnem dermatitisu pa ni znan.
English: Systemically available tacrolimus is metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4).
Slovenian: Sistemsko razpoložljivi takrolimus se presnavlja z jetrnim citokromom P450 3A4 (CYP3A4).
English: Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin with minimal diffusion into the systemic circulation.
Slovenian: Po lokalni uporabi mazila s takrolimusom se takrolimus selektivno sprošča v kožo in le minimalno difundira v sistemski obtok.
English: Systemic exposure from topical application of tacrolimus ointment is low (< 1.0 ng/ml) and is unlikely to be affected by concomitant use of substances known to be inhibitors of CYP3A4.
Slovenian: Sistemska izpostavljenost po lokalni aplikaciji mazila s takrolimusom je majhna (< 1,0 ng/ml) in ni verjetno, da bi nanjo vplivala sočasna uporaba snovi, ki zavirajo CYP3A4.
English: In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies.
Slovenian: Pri bolnikih s presadki je dolgotrajno sistemsko izpostavljenost intenzivni imunosupresiji po sistemski uporabi zaviralcev kalcinevrina spremljalo večje tveganje za limfome in malignome na koži.
English: The efficacy and safety of tacrolimus ointment in maintenance treatment of mild to severe atopic dermatitis was assessed in 524 patients in two Phase III multicentre clinical trials of similar design,
Slovenian: Učinkovitost in varnost mazila s takrolimusom za vzdrževalno zdravljenje blagega do hudega atopičnega dermatitisa so ocenili pri 524 bolnikih v dveh multicentričnih kliničnih preskušanjih III. faze, ki sta imeli podoben načrt.
English: While using Protopic, drinking alcohol may cause the skin or face to become flushed or red and feel hot.
Slovenian: Med uporabo zdravila Protopic lahko pitje alkohola povzroči, da koža na obrazu pordi in je vroča na otip.
English: Children • Protopic 0.1 % ointment is not approved for children younger than 16 years of age.
Slovenian: • Zdravilo Protopic 0,1% mazilo ni odobreno za otroke, mlajše od 16 let.
English: Protopic 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years.
Slovenian: Zdravilo Protopic 0,03% mazilo je indicirano pri odraslih, mladostnikih in otrocih, starih 2 leti in več.
English: • The active substance is tacrolimus monohydrate.
Slovenian: • Učinkovina je takrolimus monohidrat.
English: These symptoms are usually mild to moderate and generally go away within one week of using Protopic.
Slovenian: Ti simptomi so večinoma blagi do zmerni in praviloma minejo v enem tednu po začetku uporabe zdravila Protopic.
English: Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment.
Slovenian: Pekoč občutek in srbenje sta bila zelo pogosta, običajno blaga do zmerna in sta praviloma izzvenela v enem tednu po začetku zdravljenja.
English: However, the possibility of interactions cannot be ruled out and the concomitant systemic administration of known CYP3A4 inhibitors (e.g. erythromycin, itraconazole, ketoconazole and diltiazem) in patients with widespread and/or erythrodermic disease should be done with caution.
Slovenian: Vendar možnih interakcij ni mogoče izključiti in pri bolnikih z obsežno in/ali eritrodermično boleznijo je treba znane sočasne sistemske zaviralce CYP3A4 (npr. eritromicin, itrakonazol, ketokonazol in diltiazem) uporabljati previdno.
English: Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk.
Slovenian: Podatki pri ljudeh kažejo, da se takrolimus po sistemski uporabi izloča v materino mleko.
English: Animals treated with tacrolimus ointment showed a statistically significant reduction in time to skin tumour (squamous cell carcinoma) development and an increase in the number of tumours.
Slovenian: Pri živalih, ki so jim aplicirali mazilo s takrolimusom, so ugotovili statistično značilno krajši čas do pojava kožnega tumorja (skvamozni celični karcinom) in zvečanje števila tumorjev.
English: Twice daily treatment with 0.03% tacrolimus ointment was more effective than once daily administration (Table 3).
Slovenian: Zdravljenje z 0,03-% mazilom s takrolimusom dvakrat na dan je bilo učinkovitejše kot uporaba enkrat na dan (preglednica 3).
English: A very small number of people who have used Protopic ointment have had malignancies (for example, skin or lymphoma).
Slovenian: Zelo maloštevilni bolniki, ki so uporabljali zdravilo Protopic mazilo, so imeli malignome (npr. na koži ali limfom).
English: Due to the nature of the ointment vehicle, induction of vomiting or gastric lavage is not recommended.
Slovenian: Zaradi narave vehikla mazila ni priporočljivo sprožati bruhanja ali izpirati želodca.
English: In case of persistent lymphadenopathy, the aetiology of the lymphadenopathy should be investigated.
Slovenian: V primeru trdovratne limfadenopatije je treba njeno etiologijo raziskati.
English: Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopic 0.03% ointment, can be used.
Slovenian: Glede na odziv ekcema bo zdravnik presodil, ali je mogoče pogostnost uporabe zmanjšati ali uporabiti manjšo jakost, zdravilo Protopic 0,03% mazilo.
English: Care should be exercised if applying Protopic to patients with extensive skin involvement over an extended period of time, especially in children (see section 4.2).
Slovenian: Previdnost je potrebna, če zdravilo Protopic za dalj časa predpišete bolnikom z obsežno prizadetostjo kože, zlasti otrokom (glejte poglavje 4.2).
English: Usually, treatment is started with Protopic 0.1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared.
Slovenian: Zdravljenje se ponavadi začne z zdravilom Protopic 0,1% mazilo dvakrat na dan, enkrat zjutraj in enkrat zvečer, dokler ekcem ne izgine.
English: Treatment with Protopic may be associated with an increased risk of folliculitis and herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption) (see section 4.8).
Slovenian: Zdravljenje z zdravilom Protopic lahko spremlja večje tveganje za folikulitis in herpes virusne okužbe (herpes simplex dermatitis [eczema herpeticum], herpes simplex [ocvirki], Kaposijev variceliformni izpuščaj) (glejte poglavje 4.8).
English: 15 days
Slovenian: 15 dni
English: Protopic alters the abnormal immune response and relieves the skin inflammation and the itch.
Slovenian: Zdravilo Protopic spremeni nenormalen imunski odziv ter odpravi vnetje in srbenje kože.
English: 146 days
Slovenian: 146 dni
English: Protopic ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Slovenian: Učinkovitost in varnost zdravila Protopic mazilo nista raziskani za zdravljenje atopičnega dermatitisa, ki je klinično okužen.
English: If a disease exacerbation occurred, patients were treated with open-label tacrolimus ointment twice daily for a maximum of 6 weeks until the IGA score returned to ≤2.
Slovenian: primeru poslabšanja bolezni so bolnike odprto zdravili z mazilom s takrolimusom dvakrat na dan največ 6 tednov, dokler se ocena IGA ni zmanjšala na ≤ 2.