natgillin/translations-raw huggingface dataset:
The risk for humans cannot be completely ruled out as the potential for local immunosuppression with the long-term use of tacrolimus ointment is unknown.
Tveganja za človeka ni mogoče povsem izključiti, ker možnost lokalne imunosupresije med dolgotrajno uporabo mazila s takrolimusom ni znana.
Paediatric population Frequency, type and severity of adverse reactions in children are similar to those reported in adults.
Pediatrična populacija Pogostnost, vrsta in stopnja resnosti neželenih učinkov pri otrocih so primerljive s tistimi, ki so opisane pri odraslih.
Treatment should be started twice a day for up to three weeks.
Zdravljenje je treba začeti z uporabo dvakrat na dan do tri tedne.
The response rates at month 6 were comparable to the 3-month results.
Deleži odziva so bili po 6 mesecih primerljivi rezultatom po 3 mesecih.
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100).
Opredelitev pogostnosti: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10) in občasni (≥1/1.000 do <1/100).
In the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopic should be considered.
V odsotnosti jasne etiologije za limfadenopatijo ali v navzočnosti akutne infekcijske mononukleoze je treba pretehtati opustitev zdravila Protopic.
If you do not see any improvement after two weeks, see your doctor about other possible treatments.
Če po dveh tednih ne opazite izboljšanja, se z zdravnikom posvetujte o drugih možnih načinih zdravljenja.
The lowest tacrolimus blood concentration at which systemic effects can be observed is not known.
Najmanjša koncentracija takrolimusa v krvi, pri kateri je mogoče ugotoviti sistemske učinke, ni znana.
During this period all patients and control subjects (n=44) received a primary immunisation and a rechallenge with a protein-conjugate vaccine against Neisseria menigitidis serogroup C.
V tem obdobju so vsi bolniki in kontrolni preskušanci (n=44) prejeli primarno cepljenje ter reekspozicijo z beljakovinsko konjugiranim cepivom proti bakteriji Neisseria meningitidis seroskupine C.
• The effect of treatment with Protopic on the developing immune system in children, especially the young, has not been established.
• Učinek zdravljenja z zdravilom Protopic na razvijajoči se imunski sistem pri otrocih, posebno pri mlajših, ni ugotovljen.
In the presence of these infections, the balance of risks and benefits associated with Protopic use should be evaluated.
V primeru teh okužb je treba pretehtati tveganja in koristi uporabe zdravila Protopic.
Protopic ointment has no or negligible influence on the ability to drive and use machines.
Zdravilo Protopic nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
If no signs of improvement are seen after two weeks of treatment, further treatment options should be considered.
Če po dveh tednih zdravljenja ni znakov izboljšanja, je treba preučiti druge možnosti zdravljenja.
As with any topical medicinal product, patients should wash their hands after application if the hands are not intended for treatment.
Tako kot velja za vsa lokalna zdravila, si morajo bolniki po uporabi umiti roke, razen če gre za zdravljenje sprememb na rokah.
If accidentally applied to these areas, the ointment should be thoroughly wiped off and/or rinsed off with water.
Če slučajno pride na te predele, ga je treba z njih temeljito obrisati in/ali splakniti z vodo.
one in adult patients (≥16 years) and one in paediatric patients (2-15 years).
Eno preskušanje je zajelo odrasle (≥ 16 let), eno pa pediatrične bolnike (od 2 do 15 let).
Protopic can be used for short-term and intermittent long-term treatment.
Zdravilo Protopic se lahko uporablja za kratkotrajno in dolgotrajno zdravljenje s prekinitvami.
Analysis of the response rate at week 5 showed equivalence between the treatment groups (hydrocortisone 98.3%, tacrolimus ointment 95.4%; 7-11 years: 100% in both arms).
Analiza stopnje odziva v 5. tednu ni pokazala razlik med študijskima skupinama (hidrokortizon: 98,3%, mazilo s takrolimusom: 95,4%; 7-11 let: 100% v obeh skupinah).
Protopic ointment should not be used in children aged below 2 years until further data are available.
Zdravila Protopic mazilo se ne sme uporabljati pri otrocih, mlajših od 2 let, dokler ne bodo na voljo dodatni podatki.
Elderly Specific studies have not been conducted in older people (see flare treatment section above).
Posebne študije pri starejših ljudeh niso bile izvedene (glejte zgornje poglavje o zdravljenju izbruha bolezni).
Oral use of tacrolimus is also not recommended to treat these skin conditions.
Peroralna uporaba takrolimusa se prav tako ne priporoča za zdravljenje teh kožnih bolezni.
Physicians should advise patients on appropriate sun protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing.
Zdravniki morajo bolnikom svetovati o ustreznih načinih zaščite pred soncem, npr. zmanjšanje časa, prebitega na soncu, uporabo sredstev za sončenje in zakritje kože z ustreznimi oblačili.
The potential for local immunosuppression (possibly resulting in infections or cutaneous malignancies) in the long term (i.e. over a period of years) is unknown (see section 5.1).
Potencial za lokalno imunosupresijo (ki bi morda lahko povzročila okužbe ali kožne malignome) med dolgotrajnim zdravljenjem (tj. v obdobju več let) ni znan (glejte poglavje 5.1).
Concomitant use of other topical preparations has not been assessed.
Sočasna uporaba drugih lokalnih pripravkov ni raziskana.
• Avoid exposing the skin to long periods of sunlight or artificial sunlight such as tanning beds.
• Kože ne smete dolgo časa izpostavljati sončni svetlobi ali umetni sončni svetlobi, npr. v solarijih.
These skin conditions may increase systemic absorption of tacrolimus.
Te kožne bolezni lahko zvečajo sistemsko absorpcijo takrolimusa.
Treatment should not be continuous on a long-term basis.
Dolgotrajno zdravljenje ne sme biti neprekinjeno.
No effect on immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity has been observed (see section 5.1).
Zaznali niso nobenega vpliva niti na takojšnji odziv na cepljenje in na izgrajevanje imunskega spomina niti na humoralno in celično imunost (glejte poglavje 5.1).
In a subanalysis of a pooled population of patients with moderate to severe atopic dermatitis these differences remained statistically significant (Table 4).
V subanalizi skupne populacije bolnikov z zmernim do hudim atopičnim dermatitisom so te razlike ostale statistično značilne (preglednica 4).
Protopic ointment should not be used during pregnancy unless clearly necessary.
Zdravila Protopic mazilo ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
If you spend time outdoors after applying Protopic, use a sunscreen and wear loose fitting clothing that protects the skin from the sun.
Če greste po uporabi zdravila Protopic na prosto, uporabite sredstvo za sončenje in oblecite ohlapna oblačila, ki kožo varujejo pred soncem.
Ophthalmic Herpes Infection*
Očesna okužba z virusom herpes*
• If you have any skin malignancies (tumours) or if you have a weakened immune system (immuno-compromised) whatever the cause.
• Če imate katerokoli vrsto kožnih malignomov (tumorji), ali če imate oslabljen imunski sistem (če ste imunokompromitirani), ne glede na vzrok;
• If you notice any change to the appearance of your skin, please inform your physician.
• Če opazite kakršnekoli spremembe na koži, to povejte svojemu zdravniku.
The changes were caused by high systemic exposure of rodents resulting from high transdermal absorption of tacrolimus.
Spremembe je povzročila velika sistemska izpostavljenost glodavcev, ki je bila posledica velike transdermalne absorpcije takrolimusa.
Table 4: Efficacy (moderate to severe subpopulation)
Preglednica 4: Učinkovitost (populacija z zmerno do hudo boleznijo)
Median time to first DE 123 days
Mediana časa do prvega
There are no adequate data from the use of tacrolimus ointment in pregnant women.
Ni zadostnih podatkov o uporabi mazila s takrolimusom pri nosečnicah.
Via its binding to a specific cytoplasmic immunophilin (FKBP12), tacrolimus inhibits calciumdependent signal transduction pathways in T cells, thereby preventing the transcription and synthesis of IL-2, IL-3, IL-4, IL-5 and other cytokines such as GM-CSF, TNF-α and IFN-γ.
Z vezavo na specifični citoplazemski imunofilin (FKBP12) takrolimus zavre od kalcija odvisne poti prevajanja v celicah T ter tako prepreči transkripcijo in sintezo IL-2, IL-3, IL-4, IL-5 in drugih citokinov, npr. GM-CSF, TNF-α in IFN-γ.
Hypersensitivity to the active substance, macrolides in general, or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino, na makrolide na splošno, ali katerokoli pomožno snov, navedeno v poglavju 6.1.
• If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6) or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).
• Če ste alergični na takrolimus ali katero koli sestavino tega zdravila (navedeno v poglavju 6) ali na makrolidne antibiotike (npr. azitromicin, klaritromicin, eritromicin).
What Protopic is and what it is used for What you need to know before you use Protopic How to use Protopic
Kaj je zdravilo Protopic in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Protopic Kako uporabljati zdravilo Protopic
If you forget to use Protopic
Če ste pozabili uporabiti zdravilo Protopic
Thereafter, patients entered a double-blind disease control period (DCP) for up to 12 months.
Potem so bolniki vstopili v dvojno slepo obdobje obvladovanja bolezni, ki je trajalo do 12 mesecev.
When observed, blood concentrations exceeding 1.0 ng/ml were transient.
V primerih, ko so zabeležili koncentracijo v krvi prek 1,0 ng/ml, je bila prehodna.
The efficacy and safety of Protopic was assessed in more than 18,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
Učinkovitost in varnost zdravila Protopic so ocenili pri več kot 18.500 bolnikih, zdravljenih z mazilom s takrolimusom v kliničnih raziskavah od I. do III. faze.
An interaction study with protein-conjugated vaccine against Neisseria menigitidis serogroup C has been investigated in children aged 2-11 years.
Beljakovinsko konjugirano cepivo proti bakteriji Neisseria meningitidis seroskupine C so preučevali v študiji medsebojnega delovanja pri otrocih, starih od 2 do 11 let.
Embryo/foetal toxicity was observed in rats and rabbits, but only at doses that caused significant toxicity in maternal animals.
Pri podganah in kuncih so opažali toksičnost za zarodek/plod, vendar le v odmerkih, ki so povzročili pomembne toksične učinke pri samicah-materah.
Protopic with alcohol
Zdravilo Protopic skupaj z alkoholom
What Protopic is and what it is used for
Kaj je zdravilo Protopic in za kaj ga uporabljamo
Adverse reactions with suspected relationship to treatment are listed below by system organ class.
Neželene reakcije, za katere obstaja sum, da so povezane z zdravljenjem, so navedene spodaj po organskih sistemih.
In a study of maintenance treatment (twice weekly treatment) in adults and children with moderate and severe atopic dermatitis the following adverse events were noted to occur more frequently than in the control group: application site impetigo (7.7% in children) and application site infections (6.4% in children and 6.3% in adults).
Vzdrževalno zdravljenje V študiji vzdrževalnega zdravljenja (zdravljenje dvakrat na teden) pri odraslih in otrocih z zmernim in hudim atopičnim dermatitisom so naslednje neželene učinke zabeležili pogosteje kot v kontrolni skupini: impetigo na mestu uporabe (7,7% pri otrocih) in okužbe na mestu uporabe (6,4% pri otrocih in 6,3% pri odraslih).
In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application.
V kliničnih študijah je približno 50% bolnikov kot neželeni učinek na mestu uporabe doživelo draženje kože.
In a 24-month dermal carcinogenicity study performed in mice with 0.1% ointment, no skin tumours were observed.
V 24-mesečni raziskavi dermalne kancerogenosti pri miših, opravljeni z 0,1-% mazilom, niso opazili tumorjev kože.
The review of the child`s condition after 12 months treatment should include suspension of treatment to assess the need to continue this regimen and to evaluate the course of the disease.
Ponovni pregled zdravstvenega stanja po 12-mesečnem zdravljenju pri otrocih vključuje prekinitev zdravljenja, da se oceni potreba po nadaljevanju takšnega režima zdravljenja ter ovrednoti potek bolezni.
If symptoms reappear you should use Protopic twice daily as outlined above and arrange to see your doctor to review your treatment.
Če se simptomi znova pojavijo, morate uporabljati zdravilo Protopic dvakrat dnevno, kot je opisano zgoraj, in se dogovoriti za pregled pri zdravniku, ki bo znova ocenil vaše zdravljenje.
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.
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.
Patients may be at an increased risk of folliculitis, acne and herpes viral infections.
Bolnike lahko bolj ogrožajo folikulitis, akne in herpes virusne okužbe.
Protopic ointment should not be applied under occlusion because this method of administration has not been studied in patients (see section 4.4).
Zdravila Protopic mazilo se ne sme uporabiti pod okluzijo, kajti takšen način uporabe ni bil preskušan na bolnikih (glejte poglavje 4.4).
Patients with atopic dermatitis are predisposed to superficial skin infections.
Bolniki z atopičnim dermatitisom so nagnjeni k površinskim okužbam kože.
Thereafter, patients are considered suitable for maintenance treatment (see below).
Potem se pri bolnikih lahko začne z vzdrževalnim zdravljenjem (glejte spodaj).
Contents of the pack and other information What Protopic contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Protopic
You may use moisturising creams and lotions during treatment with Protopic but these products should not be used within two hours of applying Protopic.
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.
Improvement ≥ 90% in Physician's Global Evaluation
Izboljšanje za ≥ 90% po zdravniški celotni oceni
• Protopic may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees.
• Zdravilo Protopic lahko uporabljate na večini delov telesa, tudi na obrazu, vratu in v komolčnih in kolenskih pregibih.
The overall incidence of adverse events tended to decrease as the study progressed for all patients independent of age.
Celotna incidenca neželenih učinkov se je med potekom raziskave zmanjševala pri vseh bolnikih, ne glede na starost.
Protopic treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Zdravljenje z zdravilom Protopic morajo uvesti zdravniki, ki imajo izkušnje z diagnosticiranjem in zdravljenjem atopičnega dermatitisa.
In animals, tacrolimus ointment suppressed inflammatory reactions in experimental and spontaneous dermatitis models that resemble human atopic dermatitis.
Pri živalih je mazilo s takrolimusom zavrlo vnetno reakcijo v modelih eksperimentalnega in spontanega dermatitisa, podobnih atopičnemu dermatitisu pri človeku.
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.
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.
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.
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.
Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri sistemski uporabi (glejte poglavje 5.3).
There is no experience with concomitant use of systemic steroids or immunosuppressive agents.
Izkušenj s sočasno uporabo sistemskih steroidov ali imunosupresivov ni.
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.
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.
Lymphadenopathy present at initiation of therapy should be investigated and kept under review.
Limfadenopatijo, ki je prisotna že ob začetku zdravljenja, je treba raziskati in spremljati.
Generally, improvement is seen within one week of starting treatment.
Običajno je izboljšanje vidno v prvem tednu po začetku zdravljenja.
Long-term topical treatment of rats with tacrolimus led to systemic toxicity including alterations of kidneys, pancreas, eyes and nervous system.
Dolgoročno lokalno zdravljenje podgan s takrolimusom je povzročilo sistemske toksične učinke, vključno s spremembami na ledvicah, pankreasu, očeh in živčevju.
Afterwards the frequency of application should be reduced to once a day until clearance of the lesion (see section 4.4).
Potem je treba pogostnost uporabe zmanjšati na enkrat na dan in zdravilo uporabljati, dokler spremembe ne izginejo (glejte poglavje 4.4).
Butylhydroxytoluene (E321) 15 micrograms/g ointment.
Butilhidroksitoluen (E321) 15 mikrogramov/g mazila.
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.
Med zdravljenjem z zdravilom Protopic je potrebno bolnike, predvsem pediatrične, nenehno spremljati glede odziva na zdravljenje in stalne potrebe po zdravljenju.
The three most common adverse events reported were flu-like symptoms (cold, common cold, influenza, upper respiratory infection, etc.), pruritus and skin burning.
Trije najpogosteje opisani neželeni učinki so bili gripi podobni simptomi (prehlad, nahod, influenca, okužba zgornjih dihal itn.), srbenje in pekoč občutek na koži.
Mechanism of action and pharmacodynamic effects The mechanism of action of tacrolimus in atopic dermatitis is not fully understood.
Mehanizem delovanja in farmakodinamični učinki Mehanizem delovanja takrolimusa pri atopičnem dermatitisu ni povsem jasen.
The development of any new change different from previous eczema within a treated area should be reviewed by the physician.
Če se znotraj zdravljenega področja pojavi kakršnakoli sprememba, ki se razlikuje od prejšnjega ekcema, mora takšno spremembo pregledati zdravnik.
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.
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.
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.
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.
• Wash your hands after applying Protopic unless your hands are also being treated.
• Po nanosu zdravila Protopic si umijte roke, razen če si zdravite tudi roke.
• 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).
• Če imate kožno obliko bolezni presadka proti gostitelju (to je imunski odziv na koži, ki je pogost zaplet pri bolnikih po presaditvi kostnega mozga);
After 12 months this evaluation should include suspension of Protopic treatment in paediatric patients (see section 4.2).
Po 12 mesecih naj ta ocena pri pediatričnih bolnikih vključuje prekinitev zdravljenja z zdravilom Protopic (glejte poglavje 4.2).
No adverse events previously unreported in shorter duration and/or previous studies were observed in this long-term study.
Med to dolgoročno raziskavo niso zabeležili neželenih učinkov, ki ne bi bili že pred tem opisani v kratkotrajnejših in/ali prejšnjih raziskavah.
• If you have swollen lymph nodes at initiation of treatment.
• Če imate otekle bezgavke na začetku zdravljenja.
Pruritus decreased over time in the tacrolimus groups but not in the hydrocortisone group.
Srbenje se je v skupinah s takrolimusom sčasoma zmanjšalo, v skupini s hidrokortizonom pa ne.
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.
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.
217 days
217 dni
Median number of DEs adjusted for time at risk (% of patients without any DE periods)
korigirano za čas ogroženosti (% bolnikov, pri katerih ni prišlo do PB)
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).
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).
• Do not cover the skin being treated with bandages or wraps.
• Zdravljene kože ne prekrivajte s povoji ali kako drugače.
What you need to know before you use Protopic Do not use Protopic
Kaj morate vedeti, preden boste uporabili zdravilo Protopic Ne uporabljajte zdravila Protopic
improvement in mEASI (Primary Endpoint)§§
izboljšanjem mEASI (primarni opazovani dogodek)§§
Each affected region of the skin should be treated with Protopic until lesions are cleared, almost cleared or mildly affected.
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.
If symptoms recur, twice daily treatment with Protopic 0.1% should be restarted.
Če se simptomi znova pojavijo, je ponovno treba začeti zdravljenje z zdravilom Protopic 0,1% mazilo dvakrat na dan.
Afterwards the ointment should be used once a day on each affected region of the skin until the eczema has gone away.
V nadaljevanju pa je treba mazilo na prizadetih predelih kože uporabljati enkrat na dan, dokler ekcem ne izgine.
Mutagenicity In vitro and in vivo tests did not indicate a genotoxic potential of tacrolimus.
Mutagenost Preizkusi in vitro in in vivo niso pokazali, da bi imel takrolimus genotoksičen potencial.