natgillin/translations-raw huggingface dataset:
The changes were caused by high systemic exposure of rodents resulting from high transdermal absorption of tacrolimus.
sistemska izpostavljenost glodalcev, ki je bila posledica velike transdermalne absorpcije takrolimusa.
Slightly lower body weight gain in females was the only systemic change observed in micropigs at high ointment concentrations (3%).
Edina sistemska sprememba, ki so jo pri velikih koncentracijah mazila (3%) ugotavljali pri lo
Rabbits were shown to be especially sensitive to intravenous administration of tacrolimus, reversible cardiotoxic effects being observed.
mikroprašičkih, je bilo nekoliko manjše pridobivanje telesne teže samic. vi
Mutagenicity In vitro and in vivo tests did not indicate a genotoxic potential of tacrolimus.
Ugotovljeno je, da so kunci posebej občutljivi za intravensko uporabljeni takrolimusa; opažali so reverzibilne toksične učinke na srcu. ra
Carcinogenicity
Mutagenost Zd
8 Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
Kancerogenost Raziskave sistemske kancerogenosti pri miših (18 mesecev) in podganah (24 mesecev) niso odkrile kancerogenega potenciala takrolimusa.
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.
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
is toxicity in maternal animals.
8 tumorjev.
Reduced sperm function was noted in male rats at high subcutaneous
Ni jasno, ali je učinek takrolimusa posledica sistemske imunosupresije ali lokalnega učinka.
or doses of tacrolimus.
Reprodukcijska toksičnost Pri podganah in kuncih so opažali toksičnost za zarodek/ plod, vendar le v odmerkih, ki so povzročili pomembne toksične učinke pri samicah- materah.
au 6.1 List of excipients
et 6. 1 Seznam pomožnih snovi
er White soft paraffin Liquid paraffin Propylene carbonate White beeswax ng lo Hard paraffin no
o Tekoči parafin
6.2 Incompatibilities
pr Propilenkarbonat Beli vosek
Not applicable. ct
za Trdi parafin
6.3 Shelf life du
6. 2 Inkompatibilnosti
3 years ro
nj lje 6. 3 Rok uporabnosti vo 3 leta
6.4 Special precautions for storage lp
6. 4 Posebna navodila za shranjevanje do
Do not store above 25°C. a
Shranjujte pri temperaturi do 25 °C. ā
6.5 Nature and contents of container in ic
6. 5 Vrsta ovojnine in vsebina ve
Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap. ed
Laminatna tuba z notranjo prevleko iz polietilena majhne gostote, opremljena z belo polipropilensko a
Package sizes:
navojno zaporko. m
M
Na trgu ni vseh navedenih pakiranj. ni
6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje lo
No special requirements.
Ni posebnih zahtev. vi
Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi. ra
EU/ 1/ 02/ 202/ 001
EU/ 1/ 02/ 202/ 001 EU/ 1/ 02/ 202/ 002
ed EU/ 1/ 02/ 202/ 002 EU/ 1/ 02/ 202/ 005
9 EU/ 1/ 02/ 202/ 005
th Date of first authorisation:
Datum pridobitve dovoljenja za promet:
er {DD/ MM/ YYYY} ng lo Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu no ct du ro
m Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA)
in
o http: // www. emea. europa. eu.
ic ed M
pr za a nj lje vo do ā ve a m ni lo vi ra Zd
Protopy 0.1% ointment
Protopy 0, 1% mazilo
1 g of Protopy 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
1 g mazila Protopy 0, 1% vsebuje 1, 0 mg takrolimusa v obliki takrolimus monohidrata (0, 1%).
er Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or ng are intolerant of conventional therapies such as topical corticosteroids. lo 4.2 Posology and method of administration no
nj Zdravljenje zmernega do hudega atopičnega dermatitisa pri odraslih, ki se na konvencionalne terapije, lje kot so lokalni kortikosteroidi, ne odzovejo ustrezno ali jih ne prenesejo. vo 4. 2 Odmerjanje in način uporabe
Protopy should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. ct
Zdravljenje s Protopyom morajo uvesti zdravniki, ki imajo izkušnje z diagnosticiranjem in zdravljenjem do
Treatment should be intermittent and not continuous. du
atopičnega dermatitisa. ā
Protopy ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. ro
Protopy mazilo se lahko uporabi povsod na telesu, tudi na obrazu, vratu in v fleksurah, ne pa na sluznicah.
Protopy ointment should not be applied under occlusion (see section 4.4). lp
Protopy mazilo se ne sme uporabiti pod okluzijo (glejte poglavje 4. 4). a m
Generally, improvement is seen within one week of starting a
Potem je treba ni
treatment.
zdravljenje prekiniti.
At the in
Ob prvih znakih recidiva (ponovitve) lo
first signs of recurrence (flares) of the disease symptoms, treatment should be reinitiated. ic
simptomov bolezni je treba zdravljenje znova začeti. vi
Protopy is not recommended for use in children below age of 2 years until further data are available. ed
Zaradi nezadostnih podatkov uporaba Protopya pri otrocih pod 2 leti ni priporočljiva. ra
Use in adults (16 years of age and above) M
Uporaba pri odraslih (16 let in več) Zd
Protopy is available in two strengths, Protopy 0.03% and Protopy 0.1% ointment.
Protopy je na voljo v dveh jakostih: kot Protopy 0, 03% in Protopy 0, 1% mazilo.
ed 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
et Izpostavljenost kože sončni svetlobi je treba omejiti na najmanjšo mero; med zdravljenjem z mazilom
is during use of Protopy ointment (see section 5.3).
m Protopy 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).
Physicians should advise patients on appropriate sun
Zdravniki morajo bolnikom svetovati o
or protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing.
o ustreznih načinih zaščite pred soncem, npr. zmanjšanje časa, prebitega na soncu, uporabo sredstev za
th are considered to be potentially malignant or pre-malignant.
pr sončenje in zakritje kože z ustreznimi oblačili.
au Emollients should not be applied to the same area within 2 hours of applying Protopy ointment.
za V 2 urah od uporabe mazila Protopy se na istem predelu ne sme aplicirati emoliensov.
er Protopy ointment has not been evaluated for its efficacy and safety in the treatment of clinically ng infected atopic dermatitis.
nj Učinkovitost in varnost mazila Protopy nista raziskani za zdravljenje atopičnega dermatitisa, ki je lje klinično okužen.
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 no
Bolniki z atopičnim dermatitisom so nagnjeni k površinskim okužbam kože. vo Zdravljenje s Protopyom lahko spremlja večje tveganje za herpesvirusne okužbe (herpes simplex dermatitis [eczema herpeticum], herpes simplex [ocvirki], Kaposijev variceliformni izpuščaj).
In the presence of these infections, the balance of risks and benefits associated with Protopy use should be evaluated.
V primeru teh okužb je treba pretehtati tveganja in koristi uporabe Protopya. do
malignancies) in the long term (i. e. over a period of years) is unknown (see section 5.1). du
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). ā
In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of ro
Pri bolnikih s presadki je ve
In patients using tacrolimus ointment, cases of malignancies, including cutaneous and lp
Pri bolnikih, ki so uporabljali mazilo s takrolimusom, so opisani primeri malignomov, vključno s kožnimi, in druge vrste limfomov ter a
other types of lymphoma, and skin cancers have been reported (see section 4.8).
kožni rak (glejte poglavje 4. 8).
Patients with atopic dermatitis treated with Protopy have not been found to have significant systemic tacrolimus levels. a
Pri bolnikih z atopičnim dermatitisom, ki dobivajo Protopy, niso m
Lymphadenopathy was uncommonly (0.8%) reported in clinical trials.
ugotovili pomembne sistemske koncentracije takrolimusa. ni
related to infections (skin, respiratory tract, tooth) and resolved with appropriate antibiotic therapy. ic
Bolnike lo
Transplant patients receiving immunosuppressive regimens (e. g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore patients who receive Protopy and who develop ed
s presajenimi organi, ki dobivajo imunosupresive (npr. sistemski takrolimus), bolj ogroža pojav vi
lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
limfoma; zato je treba bolnike, ki dobivajo Protopy in se jim pojavi limfadenopatija, spremljati, da bi se prepričali o njenem izginotju.
In M
Limfadenopatijo, ki je prisotna že ob začetku zdravljenja, je treba raziskati ra
case of persistent lymphadenopathy, the aetiology of the lymphadenopathy should be investigated.
V primeru trdovratne limfadenopatije je treba njeno etiologijo raziskati.
In 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 Zd
The use of Protopy ointment in patients with genetic epidermal barrier defects such as Netherton’ s syndrome is not recommended due to the potential for permanently increased systemic absorption of tacrolimus.
12 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 takrolimusa.
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).
Previdnost je potrebna, če Protopy za dalj časa predpišete bolnikom z obsežno prizadetostjo kože, zlasti otrokom (glejte poglavje 4. 2).
ed 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
is Formal topical drug interaction studies with tacrolimus ointment have not been conducted.
Formalnih raziskav interakcij zdravil z lokalnim delovanjem in mazila s takrolimusom ni bilo.
or Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous
et Takrolimus se v človeški koži ne presnavlja.
th interactions that could affect the metabolism of tacrolimus.
To kaže, da ni možnosti za perkutane interakcije, ki bi lahko vplivale na presnovo takrolimusa.
au Systemically available tacrolimus is metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4).
Sistemska
However, the
o izpostavljenost po lokalni aplikaciji mazila s takrolimusom je majhna (< 1, 0 ng/ ml) in ni verjetno, da bi
er 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 ng widespread and/ or erythrodermic disease should be done with caution. lo A potential interaction between vaccination and application of Protopy ointment has not been investigated.
Vendar možnih interakcij ni mogoče izključiti in pri bolnikih z obsežno in/ ali eritrodermično boleznijo je treba sočasne sistemske zaviralce
Because of the potential risk of vaccination failure, vaccination should be administered no
za CYP3A4 (npr. eritromicin, itrakonazol, ketokonazol in diltiazem) uporabljati previdno.
In case of live attenuated vaccination, this period should be extended to 28 days or the use of alternative vaccines should be considered. ct
Morebitne interacije med cepivi in uporabo mazila Protopy niso raziskane.
4.6 Pregnancy and lactation du
Zaradi možnega tveganja za
There are no adequate data from the use of tacrolimus ointment in pregnant women.
a neuspeh cepljenja je treba cepivo aplicirati pred začetkom zdravljenja ali v obdobju, ko zdravljenje ne poteka; pri tem mora med zadnjo uporabo Protopya in cepljenjem miniti 14 dni.
Studies in animals ro
V primeru živih
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).
The potential risk for humans is unknown. lp
Možno tveganje za ljudi do
Protopy ointment should not be used during pregnancy unless clearly necessary. a
ni znano.
Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk. in
Zdravila Protopy ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.. ā ve
Although clinical data have shown that systemic exposure from application of tacrolimus ointment is ic
Podatki pri ljudeh kažejo, da se takrolimus po sistemski uporabi izloča v materinem mleku.
low, breast-feeding during treatment with Protopy ointment is not recommended. ed
Čeprav je sistemska izpostavljenost po uporabi mazila s takrolimusom glede na klinične podatke majhna, dojenje med zdravljenjem z mazilom Protopy ni priporočljivo. a m
4.7 Effects on ability to drive and use machines M
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji ni
Protopy ointment is administered topically and is unlikely to have an effect on the ability to drive or use machines.
Protopy mazilo se uporablja lokalno, zato ni verjetno, da bi imelo kakšen vpliv na sposobnost vožnje in upravljanja s stroji. lo vi
4.8 Undesirable effects
4. 8 Neželeni učinki ra
Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment.
Pekoč občutek in srbenje sta bila zelo pogosta, ponavadi blaga do zmerna in sta praviloma Zd
Erythema was a common skin irritation adverse reaction.
izzvenela v enem tednu po začetku zdravljenja.
Sensation of warmth, pain, paraesthesia and rash at the site of
Pogost dražeč neželen učinek na koži je bil eritem.
13 application were also commonly observed.
Pogosto so opažali občutek toplote, bolečine, parestezije in izpuščaj na mestu uporabe.
General disorders and administration site conditions Very common:
Pekoč občutek na mestu uporabe,
Application site burning, application site pruritus
srbenje ne mestu uporabe
ed Common:
Pogosti:
is Infections and infestations
Infekcijske in parazitske bolezni Pogosti:
th Skin and subcutaneous tissue disorders
Bolezni kože in podkožja Pogosti:
er Nervous system disorders Common:
et Bolezni živčevja Pogosti:
Metabolism and nutrition disorders ng lo Common:
m Presnovne in prehranske motnje
Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) no
Neprenašanje alkohola (zardevanje obraza ali draženje kože po pitju alkoholnih
Rosacea ct
pr pijač)
Post-marketing: cases of malignancies, including cutaneous and other types of lymphoma, and skin du
Med postmarketinškimi izkušnjami so bili poročani naslednji neželeni učinki:
cancers, have been reported in patients using tacrolimus ointment (see section 4.4). ro
a Pomarketinško: pri bolnikih, ki so uporabljali mazilo s takrolimusom, so opisani primeri malignomov, vključno s kožnimi, in druge vrste limfomov ter kožni rak (glejte poglavje 4. 4).
Overdosage following topical administration is unlikely.
nj lje 4. 9 Preveliko odmerjanje vo Preveliko odmerjanje po lokalni uporabi ni verjetno.
Due to the nature of the ointment vehicle, induction of a
Zaradi narave vehikla mazila ni priporočljivo sprožati do
vomiting or gastric lavage is not recommended. in ic
bruhanja ali izpirati želodca. ā
PHARMACOLOGICAL PROPERTIES ed
FARMAKOLOŠKE LASTNOSTI ve
5.1 Pharmacodynamic properties M
5. 1 Farmakodinamične lastnosti a
D11AX14
D11AX14 m
Mechanism of action and pharmacodynamic effects The mechanism of action of tacrolimus in atopic dermatitis is not fully understood.
Mehanizem delovanja takrolimusa pri atopičnem dermatitisu ni povsem jasen.
While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known.
Znani so naslednji izsledki, katerih klinični pomen pri atopičnem dermatitisu pa ni znan. lo
Via its binding to a specific cytoplasmic immunophilin (FKBP12), tacrolimus inhibits calcium- dependent 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.
GM- CSF, TNF- α in IFN- γ. ra
Tacrolimus has also been shown to inhibit the release of inflammatory mediators from skin mast cells, basophils and eosinophils.
Dokazano je tudi, da takrolimus zavre sproščanje mediatorjev vnetja Zd
ed Results from clinical studies in patients The efficacy and safety of Protopy was assessed in more than 13,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
14 Učinkovitost in varnost Protopya so ocenili pri več kot 13. 500 bolnikih, zdravljenih z mazilom s takrolimusom v kliničnih raziskavah od I. do III. faze.
is In a six-month multicentre double-blind randomised trial, 0.1% tacrolimus ointment was administered
V šestmesečni multicentrični, dvojno slepi randomizirani raziskavi so 0, 1% mazilo s takrolimusom dvakrat na dan aplicirali odraslim z zmernim do hudim atopičnim dermatitisom.
or 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%
To zdravljenje so primerjali z lokalno terapijo s kortikosteroidom (0, 1% hidrokortizonbutiratom na trupu in udih oz.
th hydrocortisone acetate on face and neck).
1% hidrokortizonacetatom na obrazu in vratu).
The primary endpoint was the response rate at month 3 defined as the proportion of patients with at least 60% improvement in the mEASI (modified Eczema
Primarna končna točka je bil delež odziva po 3 mesecih, 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 Severity Index').
The response rates at month 6 were comparable to the 3-month results.
Deleži odziva so bili po 6
er Table 1
m Tabela 1
Efficacy at month 3
Učinkovitost po 3 mesecih Lokalno zdravljenje s
regimen§
Takrolimus 0, 1%
Topical corticosteroid lo (N=485)
kortikosteroidom§
Response rate of ≥ 60%
pr (N=485) Delež odziva z ≥ 60% izboljšanjem 50, 8%
Improvement ≥ 90% in Physician’ s 28.5% ct
za mEASI (primarna končna točka) §§ Izboljšanje za ≥ 90% po zdravniški 28, 5% celotni oceni
Global Evaluation § Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% du
a § Lokalno zdravljenje s kortikosteroidom = 0, 1% hidrokortizonbutirat na trupu in udih, 1%
hydrocortisone acetate on face and neck §§ higher values = greater improvement ro
nj hidrokortizonacetat na obrazu in vratu §§ višje vrednosti = večje izboljšanje lje Incidenca in narava večine neželenih učinkov sta bili v obeh terapevtskih skupinah podobni.
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 a
V vo terapevtski skupini s takrolimusom so se pogosteje pojavili pekoč občutek na koži, herpes simpleks, intoleranca za alkohol (zardevanje obraza ali občutljivost kože po zaužitju alkohola), mravljinčenje v do
There were no clinically relevant changes in the laboratory values or vital signs in in
koži, hiperestezija, akne in glivični dermatitis.
either treatment group throughout the study. ic
Med raziskavo se ne v eni ne v drugi skupini niso pojavile klinično pomembne spremembe laboratorijskih vrednosti ali vitalnih znakov. ā
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% ed
V drugi raziskavi so se otroci, stari od 2 do 15 let, z zmernim do hudim atopičnim dermatitisom tri tedne ve
hydrocortisone acetate ointment.
dvakrat na dan zdravili z 0, 03% mazilom s takrolimusom, 0, 1% mazilom s takrolimusom ali 1% mazilom s hidrokortizonacetatom.
The results of this multicentre, M
Rezultati te multicentrične, dvojno slepe a
double-blind, randomised trial showed that tacrolimus ointment, 0.03% and 0.1%, is significantly more effective (p < 0.001 for both) than 1% hydrocortisone acetate ointment (Table 2).
randomizirane raziskave so pokazali, da je mazilo s takrolimusom (tako 0, 03% kot 0, 1%) značilno učinkovitejše (p < 0, 001 za oba) kot 1% mazilo s hidrokortizonacetatom (tabela 2). m ni
Hydrocortisone acetate 1% (N=185)
Hidrokortizonacetat 1%
Median mEASI
(N=185) vi
as Percentage of
Mediani mEASI kot odstotek izhodiščne povprečne AUC (primarna ra
Baseline mean AUC (Primary Endpoint)§ Improvement ≥ 90% in Physician’ s Global Evaluation § lower values = greater improvement
končna točka) § Izboljšanje za ≥ 90% po zdravniški Zd
ed The incidence of local skin burning was higher in the tacrolimus treatment groups than in the hydrocortisone group.
celotni oceni § nižje vrednosti = večje izboljšanje
Pruritus decreased over time in the tacrolimus groups but not in the hydrocortisone group.
Incidenca lokalnega pekočega občutka na koži je bila v skupinah s takrolimusom večja kot v skupini s hidrokortizonom.
There were no clinically relevant changes in the laboratory values or vital signs
Srbenje se je v skupinah s takrolimusom sčasoma zmanjšalo, v skupini s hidrokortizonom pa ne.
is in either treatment group throughout the clinical trial.
Med klinično raziskavo se ne v eni ne v drugi skupini niso pojavile klinično pomembne spremembe laboratorijskih vrednosti ali vitalnih znakov.
or The purpose of the third multicentre, double-blind, randomised study was the assessment of efficacy
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
th 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
15 1% mazila s hidrokortizonacetatom pri otrocih z zmernim do hudim atopičnim dermatitisom.
ng lo Median mEASI Percentage Decrease (Primary Endpoint)§
Mediano zmanjšanje odstotka mEASI (primarna končna točka) §
Improvement ≥ 90% in Physician’ s Global Evaluation
et Izboljšanje za ≥ 90% po zdravniški celotni oceni
§ higher values = greater improvement ct
m § višje vrednosti = večje izboljšanje
The primary endpoint was defined as the percentage decrease in mEASI from the baseline to end of du
o Primarna končna točka je bila opredeljena kot odstotek zmanjšanja mEASI od izhodišča do konca
treatment.
pr 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 ro
Za 0, 03% mazilo s takrolimusom, uporabljano enkrat ali dvakrat na dan, je bilo v primerjavi z mazilom s hidrokortizonacetatom dvakrat na dan dokazano statistično značilno večje izboljšanje
both).
za (p < 0, 001 za oba načina uporabe).