natgillin/translations-raw huggingface dataset:
Physicians should advise patients on appropriate sun ng 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 lje ustreznih načinih zaščite pred soncem, npr. zmanjšanje časa, prebitega na soncu, uporabo sredstev za sončenje in zakritje kože z ustreznimi oblačili.
Protopy ointment should not be applied to lesions that lo are considered to be potentially malignant or pre-malignant. no
Mazila Protopy se ne sme nanašati na spremembe, ki bi vo lahko bile maligne ali predmaligne.
Emollients should not be applied to the same area within 2 hours of applying Protopy ointment.
Sočasna uporaba do
Concomitant use of other topical preparations has not been assessed.
drugih lokalnih pripravkov ni raziskana.
There is no experience with concomitant use of systemic steroids or immunosuppressive agents. ct
Izkušenj s sočasno uporabo sistemskih steroidov ali imunosupresivov ni. ā
Protopy ointment has not been evaluated for its efficacy and safety in the treatment of clinically du
Učinkovitost in varnost mazila Protopy nista raziskani za zdravljenje atopičnega dermatitisa, ki je ve
infected atopic dermatitis.
klinično okužen.
Patients with atopic dermatitis are predisposed to superficial skin ro
Bolniki z atopičnim dermatitisom so nagnjeni k površinskim okužbam kože.
Treatment with Protopy may be associated with an increased risk of herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi’ s varicelliform lp
V primeru m
In the presence of these infections, the balance of risks and benefits associated with Protopy use should be evaluated. a
Potencial za lokalno imunosupresijo (ki bi morda lahko povzročila okužbe ali kožne malignome) med ni
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). in ic
dolgotrajnim zdravljenjem (tj. v obdobju več let) ni znan (glejte poglavje 5. 1). lo
In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of ed
Pri bolnikih s presadki je vi
calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies.
dolgotrajno sistemsko izpostavljenost intenzivni imunosupresiji, po sistemski uporabi zaviralcev kalcinevrina, spremljalo večje tveganje za limfome in malignome na koži.
In patients using tacrolimus ointment, cases of malignancies, including cutaneous and M
Pri bolnikih, ki so uporabljali ra
other types of lymphoma, and skin cancers have been reported (see section 4.8).
mazilo s takrolimusom, so opisani primeri malignomov, vključno s kožnimi, in druge vrste limfomov ter kožni rak (glejte poglavje 4. 8).
Patients with atopic dermatitis treated with Protopy have not been found to have significant systemic tacrolimus levels.
Pri bolnikih z atopičnim dermatitisom, ki dobivajo Protopy, niso Zd
Transplant patients receiving immunosuppressive regimens (e. g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore patients who receive Protopy and who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Bolnike s presajenimi organi, ki dobivajo imunosupresive (npr. sistemski takrolimus), bolj ogroža pojav limfoma; zato je treba bolnike, ki dobivajo Protopy in se jim pojavi limfadenopatija, spremljati, da bi se prepričali o njenem izginotju.
3 the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopy should be considered.
V odsotnosti jasne etiologije za limfadenopatijo ali v navzočnosti akutne infekcijske mononukleoze je treba pretehtati opustitev Protopya.
Tacrolimus is extensively metabolised in the liver and although blood concentrations are low
Takrolimus se izdatno presnavlja v jetrih.
ed following topical therapy, the ointment should be used with caution in patients with hepatic failure (see section 5.2).
Po lokalnem zdravljenju je koncentracija v krvi sicer majhna, vednar je treba mazilo pri bolnikih z odpovedjo jeter vseeno uporabljati previdno (glejte poglavje 5. 2).
The safety of Protopy ointment has not been established in patients with generalised
Mazila Protopy ni priporočljivo uporabljati pri bolnikih z genetskimi okvarami epidermalne pregrade, npr. pri bolnikih z Nethertonovim sindromom, ker obstaja možnost trajno zvečane sistemske absorpcije
th erythroderma.
et takrolimusa.
au Care should be exercised if applying Protopy to patients with extensive skin involvement over an extended period of time, especially in children (see section 4.2).
m Previdnost je potrebna, če Protopy za dalj časa predpišete bolnikom z obsežno prizadetostjo kože, zlasti otrokom (glejte poglavje 4. 2).
er 4.5 Interaction with other medicinal products and other forms of interaction
o pr 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
ng Formal topical drug interaction studies with tacrolimus ointment have not been conducted. lo Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous interactions that could affect the metabolism of tacrolimus. no
za Formalnih raziskav interakcij zdravil z lokalnim delovanjem in mazila s takrolimusom ni bilo.
Systemically available tacrolimus is metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4).
Takrolimus se v človeški koži ne presnavlja.
Systemic exposure from topical application of tacrolimus ointment is low (< 1.0 ng/ ml) and is unlikely ct
To kaže, da ni možnosti za perkutane interakcije, ki bi lahko
to be affected by concomitant use of substances known to be inhibitors of CYP3A4.
a vplivale na presnovo takrolimusa.
CYP3A4 inhibitors (e. g. erythromycin, itraconazole, ketoconazole and diltiazem) in patients with widespread and/ or erythrodermic disease should be done with caution. ro
Sistemska lje 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.
A potential interaction between vaccination and application of Protopy ointment has not been lp
Vendar možnih interakcij ni mogoče vo izključiti in pri bolnikih z obsežno in/ ali eritrodermično boleznijo je treba sočasne sistemske zaviralce CYP3A4 (npr. eritromicin, itrakonazol, ketokonazol in diltiazem) uporabljati previdno. do
investigated.
Morebitne interacije med cepivi in uporabo mazila Protopy niso raziskane.
In case of live attenuated vaccination, this a
V primeru živih ā
period should be extended to 28 days or the use of alternative vaccines should be considered. in ic
atenuiranih cepiv je treba ta čas podaljšati na 28 dni ali razmisliti o drugačnem cepivu. ve
4.6 Pregnancy and lactation ed
4. 6 Nosečnost in dojenje a
The potential M
Študije na živalih so pokazale m
risk for humans is unknown.
Možno tveganje za ljudi ni znano. ni
Protopy ointment should not be used during pregnancy unless clearly necessary.
Zdravila Protopy ne smete uporabljati med nosečnostjo, razen če je nujno potrebno. lo vi
Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopy ointment is not recommended.
Čeprav je sistemska izpostavljenost po uporabi mazila s takrolimusom glede na klinične podatke majhna, dojenje ra
Alcohol intolerance (facial flushing or skin irritation after
Pogosto je bilo neprenašanje alkohola (zardevanje obraza ali draženje kože po pitju alkoholnih pijač).
is 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.
or Frequencies are defined as very common (> 1/ 10), common (> 1/ 100 ,< 1/10) and uncommon (> 1/1 ,000, < 1/100).
et (> 1/ 1. 000, < 1/ 100).
Within each frequency grouping, undesirable effects are presented in order of
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
th decreasing seriousness.
m Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
au General disorders and administration site conditions Very common:
Pekoč občutek na mestu uporabe, srbenje ne mestu uporabe
Common:
o Pogosti:
Application site burning, application site pruritus Application site warmth, application site erythema, application site pain,
Toplota na mestu uporabe, eritem na mestu uporabe, bolečine na mestu uporabe,
er application site irritation, application site paraesthesia, application site rash
pr draženje na mestu uporabe, parestezije na mestu uporabe, izpuščaj na mestu uporabe
Infections and infestations Common: ng Herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes lo simplex [cold sores], Kaposi’ s varicelliform eruption) no
Herpesvirusne okužbe (herpes simplex dermatitis [eczema herpeticum], herpes simplex [ocvirki], Kaposijev variceliformni izpuščaj)
Skin and subcutaneous tissue disorders Common:
a Bolezni kože in podkožja
Uncommon:
nj Pogosti:
Folliculitis, pruritus Acne ct
Folikulitits, srbenje
Nervous system disorders du
Bolezni živčevja
Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation) ro
Parestezije in dizestezije (hiperestezija, pekoč občutek) do
Alcohol intolerance (facial flushing or skin irritation after consumption of an lp
Neprenašanje alkohola (zardevanje obraza ali draženje kože po pitju alkoholnih pijač) ā ve
alcoholic beverage)
Bolezni kože in podkožja:
The following adverse reactions have been reported during post-marketing experience: a
Pomarketinško: pri bolnikih, ki so uporabljali mazilo s takrolimusom, so opisani primeri malignomov, m
Post-marketing: cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using tacrolimus ointment (see section 4.4). ed
vključno s kožnimi, in druge vrste limfomov ter kožni rak (glejte poglavje 4. 4). ni
4.9 Overdose M
4. 9 Preveliko odmerjanje lo
Overdosage following topical administration is unlikely.
Preveliko odmerjanje po lokalni uporabi ni verjetno. vi
Due to the nature of the ointment vehicle, induction of vomiting or gastric lavage is not recommended.
Zd
In vitro, in Langerhans cells isolated from normal human skin, tacrolimus reduced the stimulatory
5 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.
is activity towards T cells.
GM- CSF, TNF- α in IFN- γ.
or mediators from skin mast cells, basophils and eosinophils.
In vitro je takrolimus v Langerhansovih celicah, izoliranih iz normalne človeške kože, zmanjšal stimulacijsko delovanje na celice T.
In animals, tacrolimus ointment suppressed inflammatory reactions in experimental and spontaneous
Dokazano je tudi, da takrolimus zavre sproščanje mediatorjev vnetja iz kožnih mastocitov, bazofilcev in eozinofilcev.
th 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.
Tacrolimus ointment does not affect collagen synthesis
Pri bolnikih z atopičnim dermatitisom sta izboljšanje kožnih sprememb med zdravljenjem z mazilom s takrolimusom spremljala zmanjšana ekspresija receptorjev Fc na Langerhansovih celicah in zmanjšanje
er in humans.
et njihovega hiperstimulacijskega delovanja na celice T.
Results from clinical studies in patients
Mazilo s takrolimusom pri človeku ne vpliva na sintezo kolagena.
The efficacy and safety of Protopy was assessed in
m Rezultati kliničnih raziskav pri bolnikih
than 13,500 patients treated with tacrolimus
o Učinkovitost in varnost Protopya so ocenili pri več kot 13. 500 bolnikih, zdravljenih z mazilom s
ointment in Phase I to Phase III clinical trials.
pr takrolimusom v kliničnih raziskavah od I. do III. faze.
In a six-month multicentre double-blind randomised trial, 0.1% tacrolimus ointment was administered no
za V šestmesečni multicentrični, dvojno slepi randomizirani raziskavi so 0, 1% mazilo s takrolimusom dvakrat na dan aplicirali odraslim z zmernim do hudim atopičnim dermatitisom.
twice-a-day to adults with moderate to severe atopic dermatitis and compared to a topical corticosteroid based regimen (0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck).
a hidrokortizonacetatom na obrazu in vratu).
The primary endpoint was the response rate at month 3 ct
Primarna končna točka je bil delež odziva po 3 mesecih,
The response rate in the 0.1% tacrolimus du
nj določen kot delež bolnikov, ki so v obdobju od izhodišča do 3. meseca doživeli vsaj 60% izboljšanje indeksa mEASI (modificirani indeks izrazitosti in obsežnosti ekcema - 'modified Eczema Area and lje Severity Index').
group (71.6%) was significantly higher than that in the topical corticosteroid based treatment group (50.8%; p < 0.001; Table 1).
V skupini, ki je dobivala 0, 1% takrolimus, je bil delež odziva (71, 6%) značilno večji kot v skupini, zdravljeni z lokalnim kortikosteroidom (50, 8%; p < 0, 001; tabela 1).
The response rates at month 6 were comparable to the 3-month results. ro
Deleži odziva so bili po 6 vo mesecih primerljivi rezultatom po 3 mesecih.
Efficacy at month 3 lp
Učinkovitost po 3 mesecih
a
do
Topical corticosteroid regimen§
Lokalno zdravljenje s kortikosteroidom§
(N=485) Response rate of ≥ 60% in
(N=485) Delež odziva z ≥ 60% izboljšanjem 50, 8% ve
improvement in mEASI (Primary ic
mEASI (primarna končna točka) §§ Izboljšanje za ≥ 90% po zdravniški 28, 5% a
Endpoint)§§ Improvement ≥ 90% in Physician’ s 28.5% ed
47, 7%
47.7%
celotni oceni m
Global Evaluation § Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% M
§ Lokalno zdravljenje s kortikosteroidom = 0, 1% hidrokortizonbutirat na trupu in udih, 1% hidrokortizonacetat na obrazu in vratu ni
hydrocortisone acetate on face and neck §§ higher values = greater improvement
§§ višje vrednosti = večje izboljšanje
The incidence and nature of most adverse events were similar in the two treatment groups.
terapevtski skupini s takrolimusom so se pogosteje pojavili pekoč občutek na koži, herpes simpleks, vi
Skin burning, herpes simplex, alcohol intolerance (facial flushing or skin sensitivity after alcohol intake), skin tingling, hyperaesthesia, acne and fungal dermatitis occurred more often in the tacrolimus treatment group.
Med raziskavo se ne v eni ne v drugi skupini niso pojavile ra
There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the study.
Zd
6 In the second trial, children aged from 2 to 15 years with moderate to severe atopic dermatitis received twice daily treatment for three weeks of 0.03% tacrolimus ointment, 0.1% tacrolimus ointment or 1% hydrocortisone acetate ointment.
V drugi raziskavi so se otroci, stari od 2 do 15 let, z zmernim do hudim atopičnim dermatitisom tri tedne dvakrat na dan zdravili z 0, 03% mazilom s takrolimusom, 0, 1% mazilom s takrolimusom ali 1% mazilom s hidrokortizonacetatom.
Table 2
6 Tabela 2
ed Median mEASI as Percentage of Baseline mean AUC (Primary Endpoint)§
Mediani mEASI kot odstotek izhodiščne povprečne AUC (primarna končna točka) §
is Improvement ≥ 90% in Physician’ s
Izboljšanje za ≥ 90% po zdravniški celotni oceni § nižje vrednosti = večje izboljšanje
or Global Evaluation § lower values = greater improvement
et Incidenca lokalnega pekočega občutka na koži je bila v skupinah s takrolimusom večja kot v skupini s hidrokortizonom.
th The incidence of local skin burning was higher in the tacrolimus treatment groups than in the
Srbenje se je v skupinah s takrolimusom sčasoma zmanjšalo, v skupini s
au hydrocortisone group.
m hidrokortizonom pa ne.
Pruritus decreased over time in the tacrolimus groups but not in the hydrocortisone group.
Med klinično raziskavo se ne v eni ne v drugi skupini niso pojavile klinično pomembne spremembe laboratorijskih vrednosti ali vitalnih znakov.
There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the clinical trial.
o pr Namen tretje multicentrične, dvojno slepe randomizirane raziskave je bila ocena učinkovitosti in varnosti 0, 03% mazila s takrolimusom, uporabljenega enkrat ali dvakrat na dan, v primerjavi z uporabo
er The purpose of the third multicentre, double-blind, randomised study was the assessment of efficacy ng and safety of 0.03% tacrolimus ointment applied once or twice a day relative to twice daily administration of 1% hydrocortisone acetate ointment in children with moderate to severe atopic lo dermatitis.
za 1% mazila s hidrokortizonacetatom pri otrocih z zmernim do hudim atopičnim dermatitisom.
Treatment duration was for up to three weeks. no
Zdravljenje je trajalo do tri tedne.
Table 3
a Tabela 3
Hydrocortisone acetate 1% ct
Hidrokortizonacetat 1%
Tacrolimus 0.03% Twice daily (N=210)
Takrolimus 0, 03% Enkrat na dan
Twice daily (N=207) du
Takrolimus 0, 03% Dvakrat na dan
Median mEASI Percentage Decrease (Primary Endpoint)§ ro
Mediano zmanjšanje odstotka mEASI (primarna končna
47.2%
47, 2% do
Improvement ≥ 90% in Physician’ s Global Evaluation lp
Izboljšanje za ≥ 90% po zdravniški celotni oceni
13.6%
13, 6% ā
§ higher values = greater improvement a
§ višje vrednosti = večje izboljšanje ve
The primary endpoint was defined as the percentage decrease in mEASI from the baseline to end of in
Primarna končna točka je bila opredeljena kot odstotek zmanjšanja mEASI od izhodišča do konca zdravljenja.
A statistically significant better improvement was shown for once daily and twice daily 0.03% tacrolimus ointment compared to twice daily hydrocortisone acetate ointment (p < 0.001 for ic
z mazilom s hidrokortizonacetatom dvakrat na dan dokazano statistično značilno večje izboljšanje m
both).
(p < 0, 001 za oba načina uporabe).
Twice daily treatment with 0.03% tacrolimus ointment was more effective than once daily ed
Zdravljenje z 0, 03% mazilom s takrolimusom dvakrat na dan je bilo učinkovitejše kot uporaba enkrat na dan (tabela 3).
administration (Table 3).
v skupinah s takrolimusom večja kot v skupini s hidrokortizonom.
The incidence of local skin burning was higher in the tacrolimus treatment groups than in the hydrocortisone group.
Med raziskavo se ne v eni ne v drugi skupini niso pojavile klinično pomembne spremembe laboratorijskih vrednosti ali vitalnih znakov. lo
M
V četrti študiji, odprti, dolgoročni raziskavi varnosti, je približno 800 bolnikov (starih ≥ 2 leti) do štiri vi
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.
Na podlagi sprememb seštevka ra
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.
EASI v primerjavi z izhodiščem in na podlagi sprememb prizadetega območja telesne površine se je v Zd
In addition, there was no evidence of loss of efficacy throughout the duration of the clinical trial.
zaporednih časovnih točkah atopični dermatitis izboljšal vsem bolnikom, ne glede na starost.
The overall incidence of adverse events tended to decrease as the study progressed for all patients independent of age.
Poleg tega med klinično raziskavo niso opazili znakov zmanjševanja učinkovitosti.
The three most common adverse events reported were flu-like symptoms (cold, common cold,
Celotna incidenca neželenih učinkov se je med potekom raziskave zmanjševaal pri vseh bolnikih, ne glede na starost.
7 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.
Absorption Data from healthy human subjects indicate that there is little or no systemic exposure to tacrolimus following single or repeated topical application of tacrolimus ointment.
7 Absorpcija Podatki iz raziskav zdravih preiskovancev kažejo, da je sistemska izpostavljenost takrolimusu po posamični ali ponavljajoči se lokalni uporabi mazila s takrolimusom majhna ali je sploh ni.
When observed, blood concentrations exceeding
Pri večini bolnikov z atopičnim dermatitisom (odraslih in otrok), zdravljenih s posamično ali ponavljajočo se uporabo mazila s takrolimusom (0, 03 - 0, 1%), in dojenčkih starih 5 mesecev ali več zdravljenih z mazilom s takrolimusom (0, 03%), je bila koncentracija v krvi < 1, 0 ng/ ml.
However, both
V primerih, ko so zabeležili koncentracijo v krvi prek 1, 0 ng/ ml, je bila prehodna.
or the extent and the rate of topical absorption of tacrolimus decrease as the skin heals.
Sistemska izpostavljenost narašča z velikostjo zdravljenih predelov, vendar se obseg in hitrost lokalne absorpcije takrolimusa zmanjšujeta, ko se stanje kože izboljšuje.
AUC) of tacrolimus
Najmanjša
th from Protopy is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
et koncentracija takrolimusa v krvi, pri kateri je mogoče ugotoviti sistemske učinke, ni znana.
The lowest tacrolimus blood concentration at which systemic
Pri bolnikih (odraslih in otrocih), ki so se dolgo (do eno leto) zdravili z mazilom s takrolimusom, ni bilo
au effects can be observed is not known.
m znakov sistemskega kopičenja takrolimusa.
er Distribution ng 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. lo Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin with minimal diffusion into the systemic circulation. no
o Distribucija
Metabolism Metabolism of tacrolimus by human skin was not detectable.
pr Sistemska izpostavljenost je med uporabo mazila s takrolimusom majhna, zato velika vezava takrolimusa (> 98, 8%) na beljakovine v plazmi ne velja za klinično pomembno.
Systemically available tacrolimus is ct
Po lokalni uporabi mazila s takrolimusom se takrolimus selektivno sprošča v kožo in le minimalno
extensively metabolised in the liver via CYP3A4. du
za difundira v sistemski obtok.
Elimination When administered intravenously, tacrolimus has been shown to have a low clearance rate.
a Presnova V človeški koži ni bilo mogoče odkriti presnove takrolimusa.
The ro
Sistemsko razpoložljivi takrolimus se
average total body clearance is approximately 2.25 l/ h.
Povprečni celotni telesni očistek je približno 2, 25 l/ uro.
The hepatic clearance of systemically available tacrolimus could be reduced in subjects with severe hepatic impairment, or in subjects who are co- lp
Jetrni očistek sistemsko razpoložljivega takrolimusa bi se lahko zmanjšal pri osebah s hudo okvaro jeter ali osebah, ki se sočasno zdravijo z močnimi zaviralci CYP3A4. do
Following repeated topical application of the ointment the average half-life of tacrolimus was estimated to be 75 hours for adults and 65 hours for children. a in
Po večkratni lokalni uporabi mazila je bil ocenjeni povprečni razpolovni čas takrolimusa pri odraslih 75 ur in pri otrocih 65 ur. ā
5.3 Preclinical safety data ic
5. 3 Predklinični podatki o varnosti ve
Repeated dose toxicity and local tolerance ed
Toksičnost ponavljajočih se odmerkov in lokalno prenašanje Večkratno lokalno aplikacijo mazila s takrolimusom ali vehikla mazila pri podganah, kuncih in a
M
mikroprašičkih so spremljale rahle dermalne spremembe, npr. eritem, edem in papule. m
Long-term topical treatment of rats with tacrolimus led to systemic toxicity including alterations of kidneys, pancreas, eyes and nervous system.
Spremembe je povzročila velika ni