FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of tacrolimus ointment is not recommended in patients with a skin barrier defect, such as Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease.
Slovenian: Mazila s takrolimusom ni priporočljivo uporabljati pri bolnikih z okvaro kožne pregrade, npr. pri bolnikih z Nethertonovim sindromom, lamelarno ihtiozo, generalizirano eritrodermijo, ali kožnimi manifestacijami reakcije presadka proti gostitelju.
English: Hard paraffin
Slovenian: Tekoči parafin
English: Adults and adolescents (16 years of age and above) Treatment should be started with Protopic 0.1% twice a day and treatment should be continued until clearance of the lesion.
Slovenian: Odrasli in mladostniki (stari 16 let in več) Zdravljenje je treba začeti z zdravilom Protopic 0,1% mazilo dvakrat na dan in ga nadaljevati, dokler spremembe ne izginejo.
English: In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness, dryness).
Slovenian: Pri atopičnem dermatitisu čezmerna reakcija imunskega sistema v koži povzroči vnetje kože (srbenje,
English: If signs of a flare reoccur, twice daily treatment should be re-initiated (see flare treatment section above).
Slovenian: Če se znaki poslabšanja ponovijo, je treba znova uvesti zdravljenje dvakrat na dan (glejte zgornje poglavje o zdravljenju izbruha bolezni).
English: Protopic contains butylhydroxytoluene (E321)
Slovenian: Zdravilo Protopic vsebuje butilhidroksitoluen (E321)
English: • Apply Protopic as a thin layer to affected areas of your skin.
Slovenian: • Zdravilo Protopic na tanko namažite na prizadete predele kože.
English: Children • Protopic ointment is not approved for children younger than 2 years of age.
Slovenian: • Zdravilo Protopic mazilo ni odobreno za otroke, mlajše od 2 let.
English: In addition, there was no evidence of loss of efficacy throughout the duration of the clinical trial.
Slovenian: Poleg tega med klinično raziskavo niso opazili znakov zmanjševanja učinkovitosti.
English: • If you have infected lesions.
Slovenian: • Če imate okužbo na predelu kožnih sprememb.
English: No adverse events not reported previously were observed in these studies.
Slovenian: V teh študijah niso opazili nobenih neželenih učinkov, ki ne bi bili opisani že pred tem.
English: Following twice-weekly treatment application site infections have been reported in adults.
Slovenian: Pri režimu zdravljenja dvakrat na teden so poročali o okužbah na mestu uporabe pri odraslih.
English: 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).
Slovenian: 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
English: What Protopic looks like and contents of the pack
Slovenian: Izgled zdravila Protopic in vsebina pakiranja
English: Post-marketing cases of increased tacrolimus blood level have been reported in these conditions.
Slovenian: V obdobju trženja so pri teh bolnikih poročali o povišanih koncentracijah takrolimusa v krvi.
English: However, a link to Protopic ointment treatment has not been confirmed or refuted on the available evidence so far.
Slovenian: Vendar povezave z uporabo zdravila Protopic mazilo na podlagi dosedanjih ugotovitev niso niti potrdili niti ovrgli.
English: The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent.
Slovenian: Učinkovina zdravila Protopic, takrolimus monohidrat, je imunomodulacijska učinkovina.
English: Butylhydroxytoluene (E321) All-rac-α-tocopherol
Slovenian: Butilhidroksitoluen (E321) Vseracemni-α-tokoferol
English: Protopic 0.1 % ointment is indicated in adults and adolescents (16 years of age and above)
Slovenian: Zdravilo Protopic 0,1% mazilo je indicirano pri odraslih in mladostnikih (starih 16 let in več).
English: Rabbits were shown to be especially sensitive to intravenous administration of tacrolimus, reversible cardiotoxic effects being observed.
Slovenian: Ugotovljeno je, da so kunci posebej občutljivi za intravensko uporabljeni takrolimus; opažali so reverzibilne toksične učinke na srcu.
English: Ointment A white to slightly yellowish ointment.
Slovenian: mazilo Belo do rahlo rumenkasto mazilo.
English: There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the study.
Slovenian: Med raziskavo se ne v eni ne v drugi skupini niso pojavile klinično pomembne spremembe laboratorijskih vrednosti ali vitalnih znakov.
English: Systemically available tacrolimus is extensively metabolised in the liver via CYP3A4.
Slovenian: Sistemsko razpoložljivi takrolimus se izdatno presnavlja v jetrih s CYP3A4.
English: 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.
Slovenian: 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. Mazilo s takrolimusom pri človeku ne vpliva na sintezo kolagena.
English: 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.
Slovenian: Bolnike s presajenimi organi, ki dobivajo imunosupresive (npr. sistemski takrolimus), bolj ogroža pojav limfoma; zato je treba bolnike, ki dobivajo zdravilo Protopic in se jim pojavi limfadenopatija,
English: 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.
Slovenian: 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.
English: Care should be taken to avoid contact with eyes and mucous membranes.
Slovenian: Paziti je treba, da zdravilo ne pride v stik z očmi in sluznicami.
English: 142 days
Slovenian: 142 dni
English: Repeated topical administration of tacrolimus ointment or the ointment vehicle to rats, rabbits and micropigs was associated with slight dermal changes such as erythema, oedema and papules.
Slovenian: Toksičnost ponavljajočih se odmerkov in lokalno prenašanje Večkratno lokalno aplikacijo mazila s takrolimusom ali vehikla mazila pri podganah, kuncih in mikroprašičkih so spremljale rahle dermalne spremembe, npr. eritem, edem in papule.
English: Apply Protopic 0.03 % ointment twice a day for up to three weeks, once in the morning and once in the evening.
Slovenian: Zdravilo Protopic 0,03% mazilo uporabljajte dvakrat na dan, enkrat zjutraj in enkrat zvečer, največ tri tedne.
English: Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage)
Slovenian: Neprenašanje alkohola (zardevanje obraza ali draženje kože po pitju alkoholnih pijač)
English: Lymphadenopathy was uncommonly (0.8%) reported in clinical trials.
Slovenian: V kliničnih raziskavah so občasno (0,8%) poročali o limfadenopatiji.
English: Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression.
Slovenian: Zdravila Protopic ne smete uporabljati pri bolnikih s prirojeno ali pridobljeno imunsko pomanjkljivostjo ali bolnikih, ki prejemajo imunosupresivno terapijo.
English: If your lymph nodes become swollen during treatment with Protopic, consult your doctor.
Slovenian: Če vam bezgavke otečejo med zdravljenjem z zdravilom Protopic, se posvetujte z zdravnikom;
English: 17 days
Slovenian: 17 dni
English: Clinical data have shown that tacrolimus concentrations in systemic circulation after topical administration are low and, when measurable, transient.
Slovenian: 5.2 Farmakokinetične lastnosti Klinični podatki kažejo, da je koncentracija takrolimusa v sistemskem obtoku po lokalni uporabi majhna in da je v primerih, ko je merljiva, prehodna.
English: Uncommon (may affect fewer than 1 in 100 people): • acne
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): • akne
English: Median time to first DE requiring substantial intervention
Slovenian: PB, kjer je bilo potrebno bistveno posredovanje
English: Adults and adolescents (16 years of age and above)
Slovenian: Odrasli in mladostniki (stari 16 let in več)
English: Treat each affected region of your skin until the eczema has gone away.
Slovenian: Prizadete predele kože zdravite, dokler ekcem ne izgine.
English: 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.
Slovenian: 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.
English: Protopic contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Slovenian: Zdravilo Protopic vsebuje butilhidroksitoluen (E321), ki lahko povzroči lokalne kožne reakcije (npr. kontaktni dermatitis) ali draženje oči in mukoznih membran.
English: Children (2 years of age and above)
Slovenian: Otroci (stari 2 leti in več)
English: Between applications there should be 2-3 days without Protopic treatment.
Slovenian: Med eno in drugo uporabo zdravila morajo miniti 2 do 3 dnevi brez uporabe zdravila Protopic.
English: Table 1: Efficacy at month 3
Slovenian: Preglednica 1: Učinkovitost po 3 mesecih
English: • local skin infection regardless of specific cause including but not limited to: inflamed or infected hair follicles, cold sores, generalised herpes simplex infections
Slovenian: • lokalne okužbe kože ne glede na vzrok, vključno, a ne omejeno le na vnetje ali okužbo mešičkov dlak, herpes okužbe, razširjene okužbe z virusom herpes simplex; • pogosta sta tudi zardevanje obraza in draženje kože po uživanju alkohola.
English: Formal topical drug interaction studies with tacrolimus ointment have not been conducted.
Slovenian: Formalnih raziskav interakcij zdravil z lokalnim delovanjem in mazila s takrolimusom ni bilo.
English: Tacrolimus 0.1% (N=487)
Slovenian: Takrolimus 0,1% (N=487)
English: Protopic 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids.
Slovenian: Zdravilo Protopic 0,03% mazilo se uporablja za zdravljenje zmernega do hudega atopičnega dermatitisa (ekcema) pri odraslih, ki se na konvencionalne načine zdravljenja, kot so lokalni kortikosteroidi, ne odzovejo ustrezno ali jih ne prenašajo, in pri otrocih (starih 2 leti ali več), ki se na konvencionalne načine zdravljenja, kot so lokalni kortikosteroidi, ne odzovejo ustrezno.
English: Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Slovenian: Zdravljenje zmernega do hudega atopičnega dermatitisa za preprečevanje ponovnega izbruha bolezni in podaljševanje obdobij brez izbruha bolezni pri bolnikih z zelo pogostim (to je 4- ali večkrat letnim) poslabšanjem in začetnim odzivom na največ 6-tedensko zdravljenje z mazilom s takrolimusom dvakrat na dan (spremembe so izginile, so skoraj izginile ali je koža ostala le rahlo prizadeta).
English: 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.
Slovenian: 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.
English: In the comparator arm patients received 1% hydrocortisone acetate ointment (HA) for head and neck and 0.1% hydrocortisone butyrate ointment for trunk and limbs (n=111) twice a day for 2 weeks and subsequently HA twice a day to all affected areas.
Slovenian: V primerjalni skupini pa so bolniki prejeli mazilo z 1-% hidrokortizonacetatom (HA) za uporabo na predelu glave in vratu ter mazilo z 0,1-% hidrokortizonbutiratom za uporabo na predelu trupa in okončin (n=111), in sicer dvakrat dnevno v obdobju dveh tednov, v nadaljevanju pa HA, nanešeno dvakrat dnevno na vse prizadete predele telesa.
English: Table 2: Efficacy at week 3
Slovenian: Preglednica 2: Učinkovitost po 3 tednih
English: Impetigo, a superficial bacterial skin infection that usually produces blisters or sores on skin, has been reported in children.
Slovenian: Pri otrocih so poročali o impetigu, površinski bakterijski infekciji kože, ki običajno povzroča mehurje in ranice na koži.
English: Protopic ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes.
Slovenian: Zdravilo Protopic mazilo se lahko uporabi na katerem koli delu telesa, tudi na obrazu, vratu in v pregibih, ne pa na sluznicah.
English: Drug level increased* (see section
Slovenian: Povišana koncentracija zdravila* (glejte poglavje 4.4)
English: D. CONDITIONS OR RESTRUCTIONS WITH REGARD TO THE SAFE AND EFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: Protopic ointment contains butylhydroxytoluene (E321) as an excipient, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Slovenian: Zdravilo Protopic kot pomožno snov vsebuje butilhidroksitoluen (E321), ki lahko povzroči lokalne kožne reakcije (npr. kontaktni dermatitis) ali draženje oči in mukoznih membran.
English: In the same study an increased incidence of lymphoma was detected in association with high systemic exposure.
Slovenian: V isti raziskavi so ob veliki sistemski izpostavljenosti zabeležili večjo incidenco limfomov.
English: However, a link to Protopic ointment treatment has not been shown.
Slovenian: Vendar ni dokazano, da bi bilo to povezano z zdravljenjem z zdravilom Protopic mazilo.
English: Hydrocortisone acetate 1% Twice daily (N=207)
Slovenian: Hidrokortizonacetat Dvakrat na dan (N=207)
English: Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant.
Slovenian: Zdravila Protopic mazilo se ne sme nanašati na spremembe, ki bi lahko bile maligne ali predmaligne.
English: Hydrocortisone acetate 1% (N=185)
Slovenian: Hidrokortizonacetat (N=185)
English: 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).
Slovenian: Po lokalnem zdravljenju je koncentracija v krvi sicer majhna, vendar je treba mazilo pri bolnikih z odpovedjo jeter vseeno uporabljati previdno (glejte poglavje 5.2).
English: Protopic contains the active substance tacrolimus, a calcineurin inhibitor.
Slovenian: Zdravilo Protopic vsebuje zdravilno učinkovino takrolimus, ki zavira kalcinevrin.
English: Table 3: Efficacy at week 3
Slovenian: Preglednica 3: Učinkovitost po 3 tednih
English: Patients were randomised to receive either tacrolimus ointment (0.1% adults; 0.03% children) or vehicle, once a day twice weekly on Mondays and Thursdays.
Slovenian: odrasli, 0,03-% otroci) ali vehikla enkrat na dan in dvakrat na teden ob ponedeljkih in četrtkih.
English: How to store Protopic
Slovenian: Shranjevanje zdravila Protopic
English: • If you have liver failure.
Slovenian: • Če imate odpoved jeter;
English: Protopic 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Slovenian: Zdravilo Protopic 0,1% mazilo se uporablja za zdravljenje zmernega do hudega atopičnega dermatitisa (ekcema) pri odraslih, ki se na konvencionalne načine zdravljenja, kot so lokalni kortikosteroidi, ne odzovejo ustrezno ali jih ne prenašajo.
English: Tacrolimus 0.03% Twice daily (N=210)
Slovenian: Takrolimus 0,03-% Dvakrat na dan (N=210)
English: In both studies, patients with active disease entered an open-label period (OLP) during which they treated affected lesions with tacrolimus ointment twice daily until improvement had reached a predefined score (Investigator's Global Assessment [IGA] ≤2, i.e. clear, almost clear or mild disease) for a maximum of 6 weeks.
Slovenian: V obeh študijah so bolniki z aktivno boleznijo vstopili v odprto obdobje zdravljenja, med katerim so največ 6 tednov uporabljali mazilo s takrolimusom dvakrat na dan, dokler ni izboljšanje kožnih sprememb doseglo vnaprej opredeljene ocene (IGA -- Investigator's Global Assessment - raziskovalčeva globalna ocena ≤ 2, to pomeni, da so spremembe izginile, skoraj izginile ali pa gre za blago bolezen).
English: (0.03%) had blood concentrations <1.0 ng/ml.
Slovenian: zdravljenih z mazilom s takrolimusom (0,03-%), je bila koncentracija v krvi < 1,0 ng/ml.
English: If the ointment gets on any of these areas, it should be thoroughly wiped off and/or rinsed off with water.
Slovenian: ga morate z njega temeljito obrisati in/ali splakniti z vodo.
English: The hepatic clearance of systemically available tacrolimus could be reduced in subjects with severe hepatic impairment, or in subjects who are cotreated with drugs that are potent inhibitors of CYP3A4.
Slovenian: Jetrni očistek sistemsko razpoložljivega takrolimusa bi se lahko zmanjšal pri osebah s hudo okvaro jeter ali osebah, ki se sočasno zdravijo z močnimi zaviralci
English: Tacrolimus ointment did not reduce skin thickness and did not cause skin atrophy in animals.
Slovenian: Mazilo s takrolimusom pri živalih ni stanjšalo kože in ni povzročilo njene atrofije.
English: Since commercial availability a very small number of people who have used Protopic ointment have had malignancies (for example lymphoma, including skin lymphoma, and other skin tumours).
Slovenian: Odkar je zdravilo dostopno na trgu, so se pri zelo maloštevilnih bolnikih, ki so uporabljali zdravilo Protopic mazilo, pojavili malignomi (na primer limfom, vključno s kožnim limfomom, in drugi kožni tumorji).
English: 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).
Slovenian: značilno večji kot v skupini, zdravljeni z lokalnim kortikosteroidom (50,8%; p<0,001; preglednica 1).
English: Children (2 years of age and above) should use the lower strength Protopic 0.03% ointment.
Slovenian: Pri otrocih (starih 2 leti in več) je treba uporabiti nižjo jakost zdravila, Protopic 0,03% mazilo.
English: 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.
Slovenian: V 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 koži, hiperestezija, akne in glivični dermatitis.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Protopic Vsebina pakiranja in dodatne informacije
English: Tacrolimus 0.03% Once daily (N=207)
Slovenian: Takrolimus 0,03-% Enkrat na dan (N=207)
English: Overdosage following topical administration is unlikely.
Slovenian: Preveliko odmerjanje po lokalni uporabi ni verjetno.
English: • burning sensation and itching
Slovenian: • pekoč občutek in srbenje
English: Tacrolimus 0.1% (N=186)
Slovenian: Takrolimus 0,1-% (N=186)
English: Global Evaluation § Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck §§ higher values = greater improvement
Slovenian: Izboljšanje za ≥ 90% po zdravniški celotni oceni § Lokalno zdravljenje s kortikosteroidom = 0,1-% hidrokortizonbutirat na trupu in udih, 1-% hidrokortizonacetat na obrazu in vratu
English: 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).
Slovenian: 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).
English: Slightly lower body weight gain in females was the only systemic change observed in micropigs at high ointment concentrations (3%).
Slovenian: Edina sistemska sprememba, ki so jo pri velikih koncentracijah mazila (3-%) ugotavljali pri mikroprašičkih, je bilo nekoliko manjše pridobivanje telesne teže samic.
English: In patients using tacrolimus ointment, cases of malignancies, including cutaneous (i.e. cutaneous T Cell lymphomas) and other types of lymphoma, and skin cancers have been reported (see section 4.8).
Slovenian: Pri bolnikih, ki so uporabljali mazilo s takrolimusom, so opisani primeri malignomov, vključno s kožnimi (kožni Tcelični limfomi), in druge vrste limfomov ter kožni rak (glejte poglavje 4.8).
English: Rosacea (facial redness), rosacea-like dermatitis, lentigo (presence of flat brown spots on the skin), oedema at the application site and herpes eye infections have been reported during post-marketing experience.
Slovenian: rozacei podobnem vnetju kože (dermatitisu), lentigu (prisotnost ploščatih rjavih lis na koži), otekanju kože na mestu uporabe in okužbah oči z virusom herpes.
English: Most atopic dermatitis patients (adults and children) treated with single or repeated application of tacrolimus ointment (0.03-0.1%), and infants from age of 5 months treated with tacrolimus ointment
Slovenian: 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,
English: • The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321) and all-rac-α-tocopherol.
Slovenian: • Druge sestavine zdravila so beli vazelin, tekoči parafin, propilenkarbonat, beli vosek, trdi parafin, butilhidroksitoluen (E321) in vseracemni-α-tokoferol.
English: Adults (16 years of age and older)
Slovenian: Odrasli (stari 16 let in več )
English: There was no evidence of systemic accumulation of tacrolimus in patients (adults and children) treated for prolonged periods (up to one year) with tacrolimus ointment.
Slovenian: Pri bolnikih (odraslih in otrocih), ki so se dolgo (do eno leto) zdravili z mazilom s takrolimusom, ni bilo znakov sistemskega kopičenja takrolimusa.
English: Ointment 30 g
Slovenian: Mazilo 30 g 60 g