natgillin/translations-raw huggingface dataset:
However, doctors must ensure that the medicine is used appropriately.
Povezava z zdravilom Protopic ni bila dokazana, vendar se morajo zdravniki tega zavedati in zagotoviti, da se zdravilo uporablja pravilno ter da bolnika spremljajo med zdravljenjem.
The Committee for Medicinal products for Human Use (CHMP) decided that Protopic’ s benefits are greater than its risks for the treatment of moderate to severe atopic dermatitis in adults and children over the age of 2 who are not adequately responsive to or are intolerant of conventional therapies.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristni učinki zdravila Protopic pri zdravljenju zmernega do hudega atopičnega dermatitisa pri odraslih in otrocih, starih 2 leti ali več, ki se neustrezno odzivajo na običajne terapije ali pa jih ne prenašajo, večji od z njim povezanih tveganj.
They recommended that Protopic be given marketing authorisation.
Odbor je za zdravilo Protopic priporočil odobritev dovoljenja za promet z zdravilom.
Other information about Protopic:
Druge informacije o zdravilu Protopic:
The European Commission granted a marketing authorisation valid throughout the European Union, for Protopic to Astellas Pharma GmbH on 28 February 2002.
Evropska komisija je dovoljenje za promet z zdravilom Protopic, veljavno po vsej Evropski uniji, odobrila družbi Astellas Pharma GmbH dne 28. februarja 2002.
The marketing authorisation was renewed on 11-2006.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 11- 2006.
The full EPAR for Protopic is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Protopic je na voljo tukaj.
This summary was last updated in 09-2007
Ta povzetek je bil nazadnje posodobljen 09- 2007.
EU/ 1/ 02/ 201/ 001 EU/ 1/ 02/ 201/ 002 EU/ 1/ 02/ 201/ 003 EU/ 1/ 02/ 201/ 004 EU/ 1/ 02/ 201/ 005 EU/ 1/ 02/ 201/ 006
Številka EU EU/ 1/ 02/ 201/ 001 EU/ 1/ 02/ 201/ 002 EU/ 1/ 02/ 201/ 003 EU/ 1/ 02/ 201/ 004 EU/ 1/ 02/ 201/ 005 EU/ 1/ 02/ 201/ 006
Protopic Protopic Protopic Protopic Protopic Protopic
Zaščiteno ime Protopic Protopic Protopic Protopic Protopic Protopic
0.03% 0.03% 0.1% 0.1% 0.03% 0.1%
Jakost 0, 03% 0, 03% 0, 1% 0, 1% 0, 03% 0, 1%
Ointment Ointment Ointment Ointment Ointment Ointment
Farmacevtska oblika Mazilo Mazilo Mazilo Mazilo Mazilo Mazilo
Cutaneous use Cutaneous use Cutaneous use Cutaneous use Cutaneous use Cutaneous use
Pot uporabe Za dermalno uporabo Za dermalno uporabo Za dermalno uporabo Za dermalno uporabo Za dermalno uporabo Za dermalno uporabo
tube (laminate) tube (laminate) tube (laminate) tube (laminate) tube (laminate) tube (laminate)
Ovojnina Laminatna tuba Laminatna tuba Laminatna tuba Laminatna tuba Laminatna tuba Laminatna tuba
30 g 60 g 30 g 60 g 10 g 10 g
Vsebina 30 g 60 g 30 g 60 g 10 g 10 g
1 tube 1 tube 1 tube 1 tube 1 tube 1 tube
Velikost pakiranja 1 tuba 1 tuba 1 tuba 1 tuba 1 tuba 1 tuba
Protopic 0.03% ointment
Protopic 0, 03% mazilo
1 g of Protopic 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
1 g mazila Protopic 0, 03% vsebuje 0, 3 mg takrolimusa v obliki takrolimus monohidrata (0, 03%).
Protopic should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Zdravljenje s Protopicom morajo uvesti zdravniki, ki imajo izkušnje z diagnosticiranjem in zdravljenjem atopičnega dermatitisa.
Protopic ointment should be applied as a thin layer to affected areas of the skin.
Na prizadete predele kože je treba nanesti tanko plast mazila Protopic.
Protopic ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes.
Protopic mazilo se lahko uporabi povsod na telesu, tudi na obrazu, vratu in v fleksurah, ne pa na sluznicah.
Protopic ointment should not be applied under occlusion (see section 4.4).
Protopic mazilo se ne sme uporabiti pod okluzijo (glejte poglavje 4. 4).
Each affected region of the skin should be treated with Protopic until clearance occurs and then treatment should be discontinued.
Potem je treba zdravljenje prekiniti.
Protopic can be used for short term and intermittent long term treatment.
Protopic se lahko uporablja za kratkoročno in intermitentno dolgoročno zdravljenje.
Protopic is not recommended for use in children below age of 2 years until further data are available.
Zaradi nezadostnih podatkov uporaba Protopica pri otrocih pod 2 leti ni priporočljiva.
Use in children (2 years of age and above) Treatment should be started twice a day for up to three weeks.
Uporaba pri otrocih (2 leti in več) Zdravljenje je treba začeti z uporabo dvakrat na dan do tri tedne.
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).
Use in adults (16 years of age and above) Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment.
Uporaba pri odraslih (16 let in več) Protopic je na voljo v dveh jakostih: kot Protopic 0, 03% in Protopic 0, 1% mazilo.
Treatment should be started with Protopic 0.1% twice a day and treatment should be continued until clearance of the lesion.
Zdravljenje je treba začeti s Protopicom 0, 1% dvakrat na dan in ga nadaljevati, dokler spremembe ne izginejo.
If symptoms recur, twice daily treatment with Protopic 0.1% should be restarted.
Če se simptomi znova pojavijo, je ponovno treba začeti zdravljenje s Protopicom 0, 1% dvakrat na dan.
An attempt should be made to reduce the frequency of application or to use the lower strength Protopic 0.03% ointment if the clinical condition allows.
Protopic 0, 03% mazilo.
2 Use in elderly (65 years of age and above) Specific studies have not been conducted in elderly patients.
2 Uporaba pri starejših (65 let in več) Specifičnih raziskav pri starejših bolnikih ni bilo.
Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression.
Protopica ne smete uporabljati pri bolnikih s prirojeno ali pridobljeno imunsko pomanjkljivostjo in bolnikih, ki prejemajo imunosupresivno terapijo.
The effect of treatment with Protopic ointment on the developing immune system of children, especially the young, has not yet been established and this should be taken into account when prescribing to this age group (see section 4.1).
Učinek zdravljenja z mazilom Protopic na razvijajoči se imunski sistem otrok, posebno mlajših, ni ugotovljen; to je treba upoštevati, kadar se zdravilo predpisuje v tej starostni skupini (glejte poglavje 4. 1).
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).
Izpostavljenost kože sončni svetlobi je treba omejiti na najmanjšo mero; med zdravljenjem z mazilom Protopic 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).
Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant.
Mazila Protopic se ne sme nanašati na spremembe, ki bi lahko bile maligne ali predmaligne.
Emollients should not be applied to the same area within 2 hours of applying Protopic ointment.
V 2 urah od uporabe mazila Protopic se na istem predelu ne sme aplicirati emoliensov.
Protopic ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Učinkovitost in varnost mazila Protopic nista raziskani za zdravljenje atopičnega dermatitisa, ki je klinično okužen.
Before commencing treatment with Protopic ointment, clinical infections at treatment sites should be cleared.
Klinične okužbe na mestih zdravljenja je treba pred začetkom zdravljenja z mazilom Protopic odpraviti.
Treatment with Protopic may be associated with an increased risk of herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi’ s varicelliform eruption).
Zdravljenje s Protopicom 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 Protopic use should be evaluated.
V primeru teh okužb je treba pretehtati tveganja in koristi uporabe Protopica.
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).
Protopic contains the active substance tacrolimus, a calcineurin inhibitor.
Protopic vsebuje zdravilno učinkovino takrolimus, ki zavira kalcinevrin.
In patients using tacrolimus ointment, cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers have been reported (see section 4.8).
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. 8).
Patients with atopic dermatitis treated with Protopic have not been found to have significant systemic tacrolimus levels.
Pri bolnikih z atopičnim dermatitisom, ki dobivajo Protopic, niso ugotovili pomembne sistemske koncentracije takrolimusa.
Lymphadenopathy was uncommonly (0.8%) reported in clinical trials.
V kliničnih raziskavah so občasno (0, 8%) poročali o limfadenopatiji.
Transplant patients receiving immunosuppressive regimens (e. g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore patients who receive Protopic 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 Protopic in se jim pojavi limfadenopatija, spremljati, da bi se prepričali o njenem izginotju.
In
V primeru trdovratne limfadenopatije je treba njeno etiologijo raziskati.
3 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 Protopica.
Care should be taken to avoid contact with eyes and mucous membranes.
3 Paziti je treba, da zdravilo ne pride v stik z očmi in sluznicami.
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.
The use of Protopic ointment under occlusion has not been studied in patients.
Uporaba mazila Protopic pod okluzijo pri bolnikih ni raziskana.
Tacrolimus is extensively metabolised in the liver and although blood concentrations are low 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 use of Protopic 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.
Mazila Protopic ni priporočljivo uporabljati pri bolnikih z genetskimi okvarami epidermalne pregrade, npr. pri bolnikih z Nethertonovim sindromom, ker obstaja možnost trajno zvečane sistemske absorpcije takrolimusa.
The safety of Protopic ointment has not been established in patients with generalised erythroderma.
Varnost mazila Protopic ni ugotovljena pri bolnikih z generalizirano eritrodermijo.
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).
Previdnost je potrebna, če Protopic za dalj časa predpišete bolnikom z obsežno prizadetostjo kože, zlasti otrokom (glejte poglavje 4. 2).
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.
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.
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.
Vendar možnih interakcij ni mogoče izključiti in pri bolnikih z obsežno in/ ali eritrodermično boleznijo je treba sočasne sistemske zaviralce CYP3A4 (npr. eritromicin, itrakonazol, ketokonazol in diltiazem) uporabljati previdno.
A potential interaction between vaccination and application of Protopic ointment has not been investigated.
Morebitne interacije med cepivi in uporabo mazila Protopic niso raziskane.
Because of the potential risk of vaccination failure, vaccination should be administered prior to commencement of treatment, or during a treatment-free interval with a period of 14 days between the last application of Protopic and the vaccination.
Zaradi možnega tveganja za neuspeh cepljenja je treba cepivo aplicirati pred začetkom zdravljenja ali v obdobju, ko zdravljenje ne poteka; pri tem mora med zadnjo uporabo Protopica in cepljenjem miniti 14 dni.
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).
Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopic ointment is not recommended.
Čeprav je sistemska izpostavljenost po uporabi mazila s takrolimusom glede na klinične podatke majhna, dojenje med zdravljenjem z mazilom Protopic ni priporočljivo.
4 No studies on the effects on the ability to drive and use machines have been performed.
Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
Protopic ointment is administered topically and is unlikely to have an effect on the ability to drive or use machines.
Protopic mazilo se uporablja lokalno, zato ni verjetno, da bi imelo kakšen vpliv na sposobnost vožnje in upravljanja s stroji.
Frequencies are defined as very common (> 1/ 10), common (> 1/ 100 ,< 1/10) and uncommon (> 1/1 ,000, < 1/100).
Opredelitev pogostnosti: zelo pogosti (> 1/ 10), pogosti (> 1/ 100, < 1/ 10) in občasni (> 1/ 1. 000, < 1/ 100).
Application site burning, application site pruritus Application site warmth, application site erythema, application site pain, application site irritation, application site paraesthesia, application site rash
Pekoč občutek na mestu uporabe, srbenje ne mestu uporabe Toplota na mestu uporabe, eritem na mestu uporabe, bolečine na mestu uporabe, draženje na mestu uporabe, parestezije na mestu uporabe, izpuščaj na mestu uporabe
Herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi’ s varicelliform eruption)
Herpesvirusne okužbe (herpes simplex dermatitis [eczema herpeticum], herpes simplex [ocvirki], Kaposijev variceliformni izpuščaj)
Folliculitis, pruritus Acne
Folikulitits, srbenje Akne
The following adverse reactions have been reported during post-marketing experience:
Med postmarketinškimi izkušnjami so bili poročani naslednji neželeni učinki:
Rosacea
Rozacea
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).
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).
5 Pharmacotherapeutic group:
Farmakoterapevtska skupina:
Other dermatologicals, ATC code:
Druga dermatološka zdravila, oznaka ATC:
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.
In vitro, in Langerhans cells isolated from normal human skin, tacrolimus reduced the stimulatory activity towards T cells.
In vitro je takrolimus v Langerhansovih celicah, izoliranih iz normalne človeške kože, zmanjšal stimulacijsko delovanje na celice T.
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 iz kožnih mastocitov, bazofilcev in eozinofilcev.
In patients with atopic dermatitis, improvement of skin lesions during treatment with tacrolimus ointment was associated with reduced Fc receptor expression on Langerhans cells and a reduction of their hyperstimulatory activity towards T cells.
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 njihovega hiperstimulacijskega delovanja na celice T.
Tacrolimus ointment does not affect collagen synthesis in humans.
Mazilo s takrolimusom pri človeku ne vpliva na sintezo kolagena.
Results from clinical studies in patients The efficacy and safety of Protopic was assessed in more than 13,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
Rezultati kliničnih raziskav pri bolnikih Učinkovitost in varnost Protopica so ocenili pri več kot 13. 500 bolnikih, zdravljenih z mazilom s takrolimusom v kliničnih raziskavah od I. do III. faze.
In a six-month multicentre double-blind randomised trial, 0.1% tacrolimus ointment was administered 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).
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 Area and Severity Index) between baseline and month 3.
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 rate in the 0.1% tacrolimus 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).
Efficacy at month 3
Učinkovitost po 3 mesecih Lokalno zdravljenje s kortikosteroidom§ (N=485)
Response rate of ≥ 60% improvement in mEASI (Primary Endpoint)§§
Delež odziva z ≥ 60% izboljšanjem 50, 8% mEASI (primarna končna točka) §§
Improvement ≥ 90% in Physician’ s 28.5% Global Evaluation
Izboljšanje za ≥ 90% po zdravniški 28, 5% celotni oceni
§ Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck §§ higher values = greater improvement
§ Lokalno zdravljenje s kortikosteroidom = 0, 1% hidrokortizonbutirat hidrokortizonacetat na obrazu in vratu §§ višje vrednosti = večje izboljšanje
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.
The results of this multicentre, 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).
Rezultati te multicentrične, dvojno slepe 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).
6 Table 2
6 Tabela 2
Efficacy at week 3
Učinkovitost po 3 tednih
Median mEASI
Mediani mEASI kot odstotek izhodiščne povprečne AUC (primarna končna točka) §
Baseline mean AUC (Primary Endpoint)§ Improvement ≥ 90% in Physician’ s Global Evaluation § lower values = greater improvement
Izboljšanje za ≥ 90% po zdravniški celotni oceni § nižje vrednosti = večje izboljšanje
The purpose of the third multicentre, double-blind, randomised study was the assessment of efficacy 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 dermatitis.
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 1% mazila s hidrokortizonacetatom pri otrocih z zmernim do hudim atopičnim dermatitisom.
Hydrocortisone acetate 1% Twice daily (N=207)
Hidrokortizonacetat 1% Dvakrat na dan (N=207)
Tacrolimus 0.03% Once daily (N=207)
Takrolimus 0, 03% Enkrat na dan (N=207)
Tacrolimus 0.03% Twice daily (N=210)
Takrolimus 0, 03% Dvakrat na dan (N=210)
Median mEASI
Mediano zmanjšanje odstotka mEASI (primarna končna točka) §
Decrease (Primary Endpoint)§ Improvement ≥ 90% in Physician’ s Global Evaluation
Izboljšanje za ≥ 90% po zdravniški celotni oceni
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 both).
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 (p < 0, 001 za oba načina uporabe).
Twice daily treatment with 0.03% tacrolimus ointment was more effective than once daily administration (Table 3).
Zdravljenje z 0, 03% mazilom s takrolimusom dvakrat na dan je bilo učinkovitejše kot uporaba enkrat na dan (tabela 3).
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.
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.