natgillin/translations-raw huggingface dataset:
D. CONDITIONS OR RESTRUCTIONS WITH REGARD TO THE SAFE AND EFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
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.
Zdravilo Protopic kot pomožno snov vsebuje butilhidroksitoluen (E321), ki lahko povzroči lokalne kožne reakcije (npr. kontaktni dermatitis) ali draženje oči in mukoznih membran.
In the same study an increased incidence of lymphoma was detected in association with high systemic exposure.
V isti raziskavi so ob veliki sistemski izpostavljenosti zabeležili večjo incidenco limfomov.
However, a link to Protopic ointment treatment has not been shown.
Vendar ni dokazano, da bi bilo to povezano z zdravljenjem z zdravilom Protopic mazilo.
Hydrocortisone acetate 1% Twice daily (N=207)
Hidrokortizonacetat Dvakrat na dan (N=207)
Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant.
Zdravila Protopic mazilo se ne sme nanašati na spremembe, ki bi lahko bile maligne ali predmaligne.
Hydrocortisone acetate 1% (N=185)
Hidrokortizonacetat (N=185)
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, vendar je treba mazilo pri bolnikih z odpovedjo jeter vseeno uporabljati previdno (glejte poglavje 5.2).
Protopic contains the active substance tacrolimus, a calcineurin inhibitor.
Zdravilo Protopic vsebuje zdravilno učinkovino takrolimus, ki zavira kalcinevrin.
Table 3: Efficacy at week 3
Preglednica 3: Učinkovitost po 3 tednih
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.
odrasli, 0,03-% otroci) ali vehikla enkrat na dan in dvakrat na teden ob ponedeljkih in četrtkih.
How to store Protopic
Shranjevanje zdravila Protopic
• If you have liver failure.
• Če imate odpoved jeter;
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.
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.
Tacrolimus 0.03% Twice daily (N=210)
Takrolimus 0,03-% Dvakrat na dan (N=210)
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.
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).
(0.03%) had blood concentrations <1.0 ng/ml.
zdravljenih z mazilom s takrolimusom (0,03-%), je bila koncentracija v krvi < 1,0 ng/ml.
If the ointment gets on any of these areas, it should be thoroughly wiped off and/or rinsed off with water.
ga morate z njega temeljito obrisati in/ali splakniti z vodo.
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.
Jetrni očistek sistemsko razpoložljivega takrolimusa bi se lahko zmanjšal pri osebah s hudo okvaro jeter ali osebah, ki se sočasno zdravijo z močnimi zaviralci
Tacrolimus ointment did not reduce skin thickness and did not cause skin atrophy in animals.
Mazilo s takrolimusom pri živalih ni stanjšalo kože in ni povzročilo njene atrofije.
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).
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).
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).
značilno večji kot v skupini, zdravljeni z lokalnim kortikosteroidom (50,8%; p<0,001; preglednica 1).
Children (2 years of age and above) should use the lower strength Protopic 0.03% ointment.
Pri otrocih (starih 2 leti in več) je treba uporabiti nižjo jakost zdravila, Protopic 0,03% mazilo.
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.
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.
Contents of the pack and other information
Shranjevanje zdravila Protopic Vsebina pakiranja in dodatne informacije
Tacrolimus 0.03% Once daily (N=207)
Takrolimus 0,03-% Enkrat na dan (N=207)
Overdosage following topical administration is unlikely.
Preveliko odmerjanje po lokalni uporabi ni verjetno.
• burning sensation and itching
• pekoč občutek in srbenje
Tacrolimus 0.1% (N=186)
Takrolimus 0,1-% (N=186)
Global Evaluation § Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck §§ higher values = greater improvement
Izboljšanje za ≥ 90% po zdravniški celotni oceni § Lokalno zdravljenje s kortikosteroidom = 0,1-% hidrokortizonbutirat na trupu in udih, 1-% hidrokortizonacetat na obrazu in vratu
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).
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 mikroprašičkih, je bilo nekoliko manjše pridobivanje telesne teže samic.
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).
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).
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.
rozacei podobnem vnetju kože (dermatitisu), lentigu (prisotnost ploščatih rjavih lis na koži), otekanju kože na mestu uporabe in okužbah oči z virusom herpes.
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
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,
• The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321) and all-rac-α-tocopherol.
• Druge sestavine zdravila so beli vazelin, tekoči parafin, propilenkarbonat, beli vosek, trdi parafin, butilhidroksitoluen (E321) in vseracemni-α-tokoferol.
Adults (16 years of age and older)
Odrasli (stari 16 let in več )
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.
Pri bolnikih (odraslih in otrocih), ki so se dolgo (do eno leto) zdravili z mazilom s takrolimusom, ni bilo znakov sistemskega kopičenja takrolimusa.
Ointment 30 g
Mazilo 30 g 60 g
Both studies showed significant benefit with twice weekly treatment with tacrolimus ointment with regard to the primary and key secondary endpoints over a period of 12 months in a pooled population of patients with mild to severe atopic dermatitis.
Obe študiji sta v skupni populaciji bolnikov z blagim do hudim atopičnim dermatitisom pokazali značilno korist zdravljenja z mazilom s takrolimusom dvakrat na teden glede na primarne in ključne sekundarne opazovane dogodke v
Cutaneous use Read the package leaflet before use.
dermalna uporaba Pred uporabo preberite priloženo navodilo!
Adults and adolescents (16 years of age and above) Adult patients should use Protopic 0.1% ointment.
Odrasli bolniki (stari 16 let in več) morajo uporabljati zdravilo Protopic 0,1% mazilo.
The primary endpoint was the response rate at month 3
Primarni opazovani dogodek je bil delež odziva po
Vehicle Twice weekly (N=75)
Vehikel dvakrat na teden (n=75)
Vehicle Twice weekly (N=73)
Vehikel dvakrat na teden (n=73)
The primary endpoint in both studies was the number of disease exacerbations requiring a “substantial therapeutic intervention” during the DCP, defined as an exacerbation with an IGA of 3-5 (i.e. moderate, severe and very severe disease) on the first day of the flare, and requiring more than 7 days treatment.
To je bilo opredeljeno kot poslabšanje z oceno IGA od 3 do 5 (to pomeni zmerna, huda ali zelo huda bolezen) na prvi dan poslabšanja, ki je zahtevalo več kot 7 dni zdravljenja.
Tacrolimus 0.03% (N=189)
Takrolimus 0,03(N=189)
In one arm patients received Protopic 0.03% ointment (n=121) twice a day for 3 weeks and thereafter once a day until clearance.
Ena skupina bolnikov je prejela zdravilo Protopic 0,03% mazilo (n=121) v prvih treh tednih dvakrat dnevno in nato enkrat dnevno, dokler kožne spremembe niso izginile.
Protopic is available in two strengths (Protopic 0.03% and Protopic 0.1% ointment).
Zdravilo Protopic je na voljo v dveh jakostih (Protopic 0,03% in Protopic 0,1% mazilo).
Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common.
Pogosto je bilo neprenašanje alkohola (zardevanje obraza ali draženje kože po pitju alkoholnih pijač).
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. Dokazano je tudi, da takrolimus zavre sproščanje mediatorjev vnetja iz kožnih mastocitov, bazofilcev in eozinofilcev.
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.
izboljšanje indeksa mEASI (modificirani indeks izrazitosti in obsežnosti ekcema - 'modified Eczema Area and Severity Index').
Talk to your doctor before using Protopic:
Pred začetkom uporabe zdravila Protopic se posvetujte z zdravnikom:
The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period.
(AUC) mEASI kot odstotek izhodiščne, povprečene glede na obdobje zdravljenja.
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.
Če klinično stanje dopušča, je treba pogostnost uporabe poskusiti zmanjšati ali uporabiti pripravek z manjšo jakostjo, tj. Protopic 0,03% mazilo.
If you are prescribed light therapy, inform your doctor that you are using Protopic as it is not recommended to use Protopic and light therapy at the same time.
Če imate predvideno fototerapijo (zdravljenje s svetlobo), zdravniku povejte, da uporabljate zdravilo Protopic.
Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous interactions that could affect the metabolism of tacrolimus.
To kaže, da ni možnosti za perkutane interakcije, ki bi lahko vplivale na presnovo takrolimusa.
The primary endpoint was defined as the percentage decrease in mEASI from the baseline to end of treatment.
§ višje vrednosti = večje izboljšanje Primarni opazovani dogodek je bil opredeljen kot odstotek zmanjšanja mEASI od izhodišča do konca zdravljenja.
However, both 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.
There should be 2-3 days without Protopic treatment between applications.
Protopic morajo miniti 2-3 dnevi brez zdravljenja.
You may be told by your doctor to use Protopic ointment twice weekly once your atopic dermatitis has cleared or almost cleared (Protopic 0.03% for children and Protopic 0.1% for adults).
Ko kožne spremembe zaradi atopičnega dermatitisa izginejo ali skoraj izginejo, vam bo zdravnik morda predpisal, da uporabljajte zdravilo Protopic mazilo (Protopic 0,03% mazilo za otroke in Protopic 0,1% mazilo za odrasle) dvakrat tedensko.
Pruritus
Srbenje
white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321), all-rac-α-tocopherol.
beli vazelin, tekoči parafin, propilenkarbonat, beli vosek, trdi parafin, butilhidroksitoluen (E321), vseracemni-α-tokoferol.
In children, maintenance treatment should be suspended after 12 months, to assess whether the need for continued treatment still exists.
12 mesecih prekiniti in oceniti potrebo po nadaljnjem zdravljenju.
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.
Po večkratni lokalni uporabi mazila je bil ocenjeni povprečni razpolovni čas takrolimusa pri odraslih
Tacrolimus ointment does not affect collagen synthesis in humans.
Takrolimus se v človeški koži ne presnavlja.
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 zdravilom Protopic mazilo odpraviti.
Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation)
(hiperestezija, pekoč občutek)
Tacrolimus Twice weekly (N=78)
Takrolimus dvakrat na teden (n=78)
• skin tingling
• mravljinčenje v koži;
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,
Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment.
Zdravilo Protopic je na voljo v dveh jakostih: kot Protopic 0,03% in Protopic 0,1% mazilo.
Reduced sperm function was noted in male rats at high subcutaneous doses of tacrolimus.
Pri podganjih samcih so ob večjih subkutanih odmerkih takrolimusa opazili slabšo funkcijo semenčic.
Emollients should not be applied to the same area within 2 hours of applying Protopic ointment.
V 2 urah od uporabe zdravila Protopic mazilo se na istem predelu ne sme aplicirati emoliensov.
Herpes simplex, Herpes virus infection, Kaposi's varicelliform eruption*
Lokalne okužbe kože ne glede na specifično etiologijo, med drugim: herpes simplex dermatitis [eczema herpeticum], folikulitis, herpes simplex, herpes virusne okužbe, Kaposijev variceliformni izpuščaj*
1 g ointment contains: 1.0 mg tacrolimus (as monohydrate)
1 g mazila vsebuje: 1,0 mg takrolimusa (v obliki monohidrata).
Application site oedema*
Edem na mestu uporabe*
Protopic ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas of your body commonly affected by atopic dermatitis.
Za preprečitev poslabšanja je treba zdravilo Protopic mazilo enkrat dnevno dvakrat na teden (npr. v ponedeljek in četrtek) nanesti na predele, ki jih atopični dermatitis pogosto prizadene.
Metabolism of tacrolimus by human skin was not detectable.
V človeški koži ni bilo mogoče odkriti presnove takrolimusa.
Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids.
Zdravljenje zmernega do hudega atopičnega dermatitisa pri otrocih, ki se na konvencionalne terapije,
Protopic ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression to flares.
Za preprečevanje poslabšanja je treba zdravilo Protopic enkrat dnevno dvakrat na teden (npr. v ponedeljek in četrtek) nanesti na predele, ki jih atopični dermatitis pogosto prizadene.
One gram of Protopic 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
En gram zdravila Protopic 0,03% mazilo vsebuje 0,3 mg takrolimusa (v obliki takrolimus monohidrata).
Only Protopic 0.03 % ointment should be used in children from the age of 2 to 16 years.
Pri otrocih, starih od 2 do 16 let, je treba uporabiti le zdravilo Protopic 0,03% mazilo.
1 g ointment contains: 0.3 mg tacrolimus (as monohydrate)
1 g mazila vsebuje 0,3 mg takrolimusa (v obliki monohidrata).
Cases of malignancies, including cutaneous (i.e. cutaneous T Cell lymphomas) and other types of lymphoma, and skin cancers, have been reported in patients using tacrolimus ointment (see section 4.4).
Pri bolnikih, ki so uporabljali mazilo s takrolimusom, so poročali o primerih malignomov, vključno s kožnimi (kožni T-celični limfomi), in drugih vrstah limfomov ter kožnem raku (glejte poglavje 4.4).
Erythema was a common skin irritation adverse reaction.
Pogost dražeč neželen učinek na koži je bil eritem.
One gram of Protopic 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
En gram zdravila Protopic 0,1% mazilo vsebuje 1,0 mg takrolimusa (v obliki takrolimus monohidrata).
Protopic 0.03% ointment tacrolimus monohydrate
Protopic 0,03% mazilo takrolimus monohidrat
The effect of treatment with Protopic ointment on the developing immune system of children aged below 2 years has not been established (see section 4.1).
Učinek zdravljenja z zdravilom Protopic mazilo na razvijajoči se imunski sistem otrok, mlajših od
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPIC 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
PODATKI NA ZUNANJI OVOJNINI PROTOPIC 0,1% MAZILO (10 g, 30 g, 60 g ŠKATLA)
White soft paraffin Liquid paraffin Propylene carbonate White beeswax
Propilenkarbonat Beli vosek
Mean (SD) percentage of days of DE exacerbation treatment DE: disease exacerbation P<0.001 in favour of tacrolimus ointment 0.1% (adults) and 0.03% (children) for the primary and key secondary endpoints
Povprečni (standardni odklon) odstotek dni zdravljenja PB PB: poslabšanje bolezni P<0,001 v korist 0,1% mazila s takrolimusom (odrasli) in 0,03% mazila s takrolimusom (otroci) za primarne in ključne sekundarne opazovane dogodke Pri pediatričnih bolnikih (starih od 2 do 11 let) z zmerno do izrazito izraženim atopičnim dermatitisom so opravili sedemmesečno dvojno slepo randomizirano študijo s paralelno skupino.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPIC 0.03% OINTMENT (30 g, 60 g TUBE)
PODATKI NA PRIMARNI OVOJNINI PROTOPIC 0,03% MAZILO (30 g, 60 g TUBA)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPIC 0.1% OINTMENT (30 g, 60 g TUBE)
PODATKI NA PRIMARNI OVOJNINI PROTOPIC 0,1% MAZILO (30 g, 60 g TUBA)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPIC 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
PODATKI NA ZUNANJI OVOJNINI PROTOPIC 0,03% MAZILO (10 g, 30 g, 60 g ŠKATLA)
Protopic 0.1% ointment tacrolimus monohydrate
Protopic 0,1% mazilo takrolimus monohidrat
Patients who are responding to up to 6 weeks treatment using tacrolimus ointment twice daily (lesions cleared, almost cleared or mildly affected) are suitable for maintenance treatment.
Bolniki, ki se odzovejo na do 6 tednov trajajoče zdravljenje z mazilom s takrolimusom dvakrat na dan
Protopic 0.1% ointment
Protopic 0,1% mazilo
Protopic 0.03% ointment
Protopic 0,03% mazilo
Median number of DEs requiring substantial intervention adjusted for time at risk (% of patients without DE requiring substantial intervention) Median time to first DE requiring substantial intervention
Mediana števila PB, kjer je bilo potrebno bistveno posredovanje, korigirano za čas ogroženosti
When administered intravenously, tacrolimus has been shown to have a low clearance rate.
Ugotovljeno je, da je očistek intravensko uporabljenega takrolimusa majhen.
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
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).
Two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment) are available for adult patients (16 years of age and older).
Za odrasle bolnike (stare 16 let in več) sta na voljo dve jakosti zdravila Protopic (Protopic 0,03% in Protopic 0,1% mazilo).
1 g of Protopic 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
1 g zdravila Protopic 0,03% mazilo vsebuje 0,3 mg takrolimusa v obliki takrolimus monohidrata
Protopic 0.1 % ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas of your body commonly affected by atopic dermatitis.
0,1% mazilo morate enkrat dnevno nanesti na predele telesa, ki jih atopični dermatitis navadno prizadene, in sicer dvakrat v tednu (npr. v ponedeljek in četrtek).
Protopic 0.03% ointment tacrolimus monohydrate Cutaneous use
Protopic 0,03% mazilo takrolimus monohidrat dermalna uporaba
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).
V šestmesečni multicentrični dvojno slepi randomizirani raziskavi so 0,1-% mazilo s takrolimusom dvakrat na dan aplicirali odraslim z zmernim do hudim atopičnim dermatitisom.
Protopic 0.1% ointment tacrolimus monohydrate Cutaneous use
Protopic 0,1% mazilo takrolimus monohidrat dermalna uporaba
Application site erythema, Application site pain, Application site irritation, Application site paraesthesia,
draženje na mestu uporabe, parestezije na mestu uporabe,
Median number of DEs requiring substantial intervention adjusted for time at risk (% of patients without DE requiring substantial intervention)
(% bolnikov brez PB, kjer bi bilo potrebno bistveno ukrepanje)
1 g of Protopic 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
1 g zdravila Protopic 0,1% mazilo vsebuje 1,0 mg takrolimusa v obliki takrolimus monohidrata
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPIC 0.03% OINTMENT (10 g TUBE)
OVOJNINAH PROTOPIC 0,03% MAZILO (10 g TUBA)