natgillin/translations-raw huggingface dataset:
• If you have swollen lymph nodes at initiation of treatment. 
• Če imate otekle bezgavke na začetku zdravljenja.
Pruritus decreased over time in the tacrolimus groups but not in the hydrocortisone group. 
Srbenje se je v skupinah s takrolimusom sčasoma zmanjšalo, v skupini s hidrokortizonom pa ne.
The primary endpoint of this study was the response rate to vaccination, defined as the percentage of patients with a serum bactericidal antibody (SBA) titre ≥8 at the week 5 visit. 
Primarni opazovani dogodek te študije je bila stopnja odziva na cepljenje, ki je opredeljena kot odstotek bolnikov s titrom serumskih baktericidnih protiteles (SBA) ≥ 8 ob študijskem kontrolnem pregledu v 5. tednu.
217 days 
217 dni
Median number of DEs adjusted for time at risk (% of patients without any DE periods) 
korigirano za čas ogroženosti (% bolnikov, pri katerih ni prišlo do PB)
The pharmacokinetics of tacrolimus after topical application are similar to those reported in adults, with minimal systemic exposure and no evidence of accumulation (see above). 
Farmakokinetika takrolimusa po lokalni uporabi je primerljiva s tisto, ki je opisana za odrasle, in sicer minimalna sistemska izpostavljenost ter odsotnost znakov kopičenja (glejte zgoraj).
• Do not cover the skin being treated with bandages or wraps. 
• Zdravljene kože ne prekrivajte s povoji ali kako drugače.
What you need to know before you use Protopic Do not use Protopic 
Kaj morate vedeti, preden boste uporabili zdravilo Protopic Ne uporabljajte zdravila Protopic
improvement in mEASI (Primary Endpoint)§§ 
izboljšanjem mEASI (primarni opazovani dogodek)§§
Each affected region of the skin should be treated with Protopic until lesions are cleared, almost cleared or mildly affected. 
Vsak prizadeti predel kože je treba zdraviti z zdravilom Protopic, dokler spremembe skoraj ali v celoti ne izginejo oziroma dokler je koža samo še rahlo prizadeta.
If symptoms recur, twice daily treatment with Protopic 0.1% should be restarted. 
Če se simptomi znova pojavijo, je ponovno treba začeti zdravljenje z zdravilom Protopic 0,1% mazilo dvakrat na dan.
Afterwards the ointment should be used once a day on each affected region of the skin until the eczema has gone away. 
V nadaljevanju pa je treba mazilo na prizadetih predelih kože uporabljati enkrat na dan, dokler ekcem ne izgine.
Mutagenicity In vitro and in vivo tests did not indicate a genotoxic potential of tacrolimus. 
Mutagenost Preizkusi in vitro in in vivo niso pokazali, da bi imel takrolimus genotoksičen potencial.
Following twice-weekly treatment application site infections have been reported in children and adults. 
Pri režimu zdravljenja dvakrat na teden so poročali o okužbah na mestu uporabe pri otrocih in odraslih.
Median mEASI as Percentage of Baseline mean AUC (Primary Endpoint)§ 
Mediana mEASI kot odstotek izhodiščne povprečne AUC (primarni opazovani dogodek)§
The incidence of local skin burning was higher in the tacrolimus treatment groups than in the hydrocortisone group. 
Incidenca lokalnega pekočega občutka na koži je bila v skupinah s takrolimusom večja kot v skupini s hidrokortizonom.
*The adverse reaction has been reported during post-marketing experience Post-marketing 
* O neželenem učinku so poročali med izkušnjami po začetku trženja zdravila Po začetku trženja zdravila
How to use Protopic 
Kako uporabljati zdravilo Protopic
• If your doctor tells you to use Protopic twice weekly to keep your atopic dermatitis cleared, your condition should be reviewed by your doctor at least every 12 months, even if it remains under control. 
• Če vam je zdravnik predpisal zdravilo Protopic za vzdrževalno zdravljenje atopičnega dermatitisa, in sicer dvakrat tedensko, vas mora vsaj na vsakih 12 mesecev uporabe zdravila znova pregledati, tudi če se bolezen ne poslabša.
Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap. 
Laminatna tuba z notranjo prevleko iz polietilena majhne gostote, opremljena z belo polipropilensko navojno zaporko.
Patients with atopic dermatitis treated with Protopic have not been found to have significant systemic tacrolimus levels. 
Pri bolnikih z atopičnim dermatitisom, ki dobivajo zdravilo Protopic, niso ugotovili pomembne sistemske koncentracije takrolimusa.
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 zdravilom Protopic mazilo 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).
Do not apply the ointment to infected lesions. 
Mazila ne nanašajte na okužene predele;
Occlusive dressings are not recommended. 
Okluzivno povijanje ni priporočljivo.
If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible. 
Če pomotoma zaužijete mazilo, se čim prej posvetujte z zdravnikom ali farmacevtom.
The use of Protopic ointment under occlusion has not been studied in patients. 
Uporaba zdravila Protopic mazilo pod okluzijo pri bolnikih ni raziskana.
36 days 
36 dni
Protopic is a white to slightly yellowish ointment. 
Zdravilo Protopic je belo do rahlo rumenkasto mazilo.
In a photocarcinogenicity study, albino hairless mice were chronically treated with tacrolimus ointment and UV radiation. 
V raziskavi fotokancerogenosti so brezdlakave albine miši kronično zdravili z mazilom s takrolimusom in UV-obsevanjem.
• If you have an inherited skin barrier disease such as Netherton's syndrome, lamellar ichthyosis (extensive scaling of the skin due to a thickening of the outer layer of the skin), or if you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire skin). 
• Če imate prirojeno bolezen kožne pregrade, kot je na primer Nethertonov sindrom, lamelarna ihtioza (zadebeljena zunanja plast kože, ki se intenzivno lušči) ali pa če imate generalizirano eritrodermijo (vnetna pordelost in luščenje kože po celem telesu);
Topical corticosteroid regimen§ (N=485) 
Lokalno zdravljenje s kortikosteroidom§ (N=485)
Sensation of warmth, pain, paraesthesia and rash at the site of application were also commonly observed. 
Pogosto so opažali tudi občutek toplote, bolečine, parestezije in izpuščaj na mestu uporabe.
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.
Systemically available tacrolimus is metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4). 
Sistemsko razpoložljivi takrolimus se presnavlja z jetrnim citokromom P450 3A4 (CYP3A4).
Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin with minimal diffusion into the systemic circulation. 
Po lokalni uporabi mazila s takrolimusom se takrolimus selektivno sprošča v kožo in le minimalno difundira v sistemski obtok.
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.
In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies. 
Pri bolnikih s presadki je dolgotrajno sistemsko izpostavljenost intenzivni imunosupresiji po sistemski uporabi zaviralcev kalcinevrina spremljalo večje tveganje za limfome in malignome na koži.
The efficacy and safety of tacrolimus ointment in maintenance treatment of mild to severe atopic dermatitis was assessed in 524 patients in two Phase III multicentre clinical trials of similar design, 
Učinkovitost in varnost mazila s takrolimusom za vzdrževalno zdravljenje blagega do hudega atopičnega dermatitisa so ocenili pri 524 bolnikih v dveh multicentričnih kliničnih preskušanjih III. faze, ki sta imeli podoben načrt.
While using Protopic, drinking alcohol may cause the skin or face to become flushed or red and feel hot. 
Med uporabo zdravila Protopic lahko pitje alkohola povzroči, da koža na obrazu pordi in je vroča na otip.
Children • Protopic 0.1 % ointment is not approved for children younger than 16 years of age. 
• Zdravilo Protopic 0,1% mazilo ni odobreno za otroke, mlajše od 16 let.
Protopic 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years. 
Zdravilo Protopic 0,03% mazilo je indicirano pri odraslih, mladostnikih in otrocih, starih 2 leti in več.
• The active substance is tacrolimus monohydrate. 
• Učinkovina je takrolimus monohidrat.
These symptoms are usually mild to moderate and generally go away within one week of using Protopic. 
Ti simptomi so večinoma blagi do zmerni in praviloma minejo v enem tednu po začetku uporabe zdravila Protopic.
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, običajno blaga do zmerna in sta praviloma izzvenela v enem tednu po začetku zdravljenja.
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 znane sočasne sistemske zaviralce CYP3A4 (npr. eritromicin, itrakonazol, ketokonazol in diltiazem) uporabljati previdno.
Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk. 
Podatki pri ljudeh kažejo, da se takrolimus po sistemski uporabi izloča v materino mleko.
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 tumorjev.
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 (preglednica 3).
A very small number of people who have used Protopic ointment have had malignancies (for example, skin or lymphoma). 
Zelo maloštevilni bolniki, ki so uporabljali zdravilo Protopic mazilo, so imeli malignome (npr. na koži ali limfom).
Due to the nature of the ointment vehicle, induction of vomiting or gastric lavage is not recommended. 
Zaradi narave vehikla mazila ni priporočljivo sprožati bruhanja ali izpirati želodca.
In case of persistent lymphadenopathy, the aetiology of the lymphadenopathy should be investigated. 
V primeru trdovratne limfadenopatije je treba njeno etiologijo raziskati.
Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopic 0.03% ointment, can be used. 
Glede na odziv ekcema bo zdravnik presodil, ali je mogoče pogostnost uporabe zmanjšati ali uporabiti manjšo jakost, zdravilo Protopic 0,03% mazilo.
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 zdravilo Protopic za dalj časa predpišete bolnikom z obsežno prizadetostjo kože, zlasti otrokom (glejte poglavje 4.2).
Usually, treatment is started with Protopic 0.1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared. 
Zdravljenje se ponavadi začne z zdravilom Protopic 0,1% mazilo dvakrat na dan, enkrat zjutraj in enkrat zvečer, dokler ekcem ne izgine.
Treatment with Protopic may be associated with an increased risk of folliculitis and herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption) (see section 4.8). 
Zdravljenje z zdravilom Protopic lahko spremlja večje tveganje za folikulitis in herpes virusne okužbe (herpes simplex dermatitis [eczema herpeticum], herpes simplex [ocvirki], Kaposijev variceliformni izpuščaj) (glejte poglavje 4.8).
15 days 
15 dni
Protopic alters the abnormal immune response and relieves the skin inflammation and the itch. 
Zdravilo Protopic spremeni nenormalen imunski odziv ter odpravi vnetje in srbenje kože.
146 days 
146 dni
Protopic ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis. 
Učinkovitost in varnost zdravila Protopic mazilo nista raziskani za zdravljenje atopičnega dermatitisa, ki je klinično okužen.
If a disease exacerbation occurred, patients were treated with open-label tacrolimus ointment twice daily for a maximum of 6 weeks until the IGA score returned to ≤2. 
primeru poslabšanja bolezni so bolnike odprto zdravili z mazilom s takrolimusom dvakrat na dan največ 6 tednov, dokler se ocena IGA ni zmanjšala na ≤ 2.
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. 
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.
Hard paraffin 
Tekoči parafin
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. 
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.
In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness, dryness). 
Pri atopičnem dermatitisu čezmerna reakcija imunskega sistema v koži povzroči vnetje kože (srbenje,
If signs of a flare reoccur, twice daily treatment should be re-initiated (see flare treatment section above). 
Če se znaki poslabšanja ponovijo, je treba znova uvesti zdravljenje dvakrat na dan (glejte zgornje poglavje o zdravljenju izbruha bolezni).
Protopic contains butylhydroxytoluene (E321) 
Zdravilo Protopic vsebuje butilhidroksitoluen (E321)
• Apply Protopic as a thin layer to affected areas of your skin. 
• Zdravilo Protopic na tanko namažite na prizadete predele kože.
Children • Protopic ointment is not approved for children younger than 2 years of age. 
• Zdravilo Protopic mazilo ni odobreno za otroke, mlajše od 2 let.
In addition, there was no evidence of loss of efficacy throughout the duration of the clinical trial. 
Poleg tega med klinično raziskavo niso opazili znakov zmanjševanja učinkovitosti.
• If you have infected lesions. 
• Če imate okužbo na predelu kožnih sprememb.
No adverse events not reported previously were observed in these studies. 
V teh študijah niso opazili nobenih neželenih učinkov, ki ne bi bili opisani že pred tem.
Following twice-weekly treatment application site infections have been reported in adults. 
Pri režimu zdravljenja dvakrat na teden so poročali o okužbah na mestu uporabe pri odraslih.
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
What Protopic looks like and contents of the pack 
Izgled zdravila Protopic in vsebina pakiranja
Post-marketing cases of increased tacrolimus blood level have been reported in these conditions. 
V obdobju trženja so pri teh bolnikih poročali o povišanih koncentracijah takrolimusa v krvi.
However, a link to Protopic ointment treatment has not been confirmed or refuted on the available evidence so far. 
Vendar povezave z uporabo zdravila Protopic mazilo na podlagi dosedanjih ugotovitev niso niti potrdili niti ovrgli.
The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent. 
Učinkovina zdravila Protopic, takrolimus monohidrat, je imunomodulacijska učinkovina.
Butylhydroxytoluene (E321) All-rac-α-tocopherol 
Butilhidroksitoluen (E321) Vseracemni-α-tokoferol
Protopic 0.1 % ointment is indicated in adults and adolescents (16 years of age and above) 
Zdravilo Protopic 0,1% mazilo je indicirano pri odraslih in mladostnikih (starih 16 let in več).
Rabbits were shown to be especially sensitive to intravenous administration of tacrolimus, reversible cardiotoxic effects being observed. 
Ugotovljeno je, da so kunci posebej občutljivi za intravensko uporabljeni takrolimus; opažali so reverzibilne toksične učinke na srcu.
Ointment A white to slightly yellowish ointment. 
mazilo Belo do rahlo rumenkasto mazilo.
There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the study. 
Med raziskavo se ne v eni ne v drugi skupini niso pojavile klinično pomembne spremembe laboratorijskih vrednosti ali vitalnih znakov.
Systemically available tacrolimus is extensively metabolised in the liver via CYP3A4. 
Sistemsko razpoložljivi takrolimus se izdatno presnavlja v jetrih s CYP3A4.
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. Mazilo s takrolimusom pri človeku ne vpliva na sintezo kolagena.
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 zdravilo Protopic in se jim pojavi limfadenopatija,
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. 
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.
Care should be taken to avoid contact with eyes and mucous membranes. 
Paziti je treba, da zdravilo ne pride v stik z očmi in sluznicami.
142 days 
142 dni
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. 
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.
Apply Protopic 0.03 % ointment twice a day for up to three weeks, once in the morning and once in the evening. 
Zdravilo Protopic 0,03% mazilo uporabljajte dvakrat na dan, enkrat zjutraj in enkrat zvečer, največ tri tedne.
Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) 
Neprenašanje alkohola (zardevanje obraza ali draženje kože po pitju alkoholnih pijač)
Lymphadenopathy was uncommonly (0.8%) reported in clinical trials. 
V kliničnih raziskavah so občasno (0,8%) poročali o limfadenopatiji.
Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression. 
Zdravila Protopic ne smete uporabljati pri bolnikih s prirojeno ali pridobljeno imunsko pomanjkljivostjo ali bolnikih, ki prejemajo imunosupresivno terapijo.
If your lymph nodes become swollen during treatment with Protopic, consult your doctor. 
Če vam bezgavke otečejo med zdravljenjem z zdravilom Protopic, se posvetujte z zdravnikom;
17 days 
17 dni
Clinical data have shown that tacrolimus concentrations in systemic circulation after topical administration are low and, when measurable, transient. 
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.
Uncommon (may affect fewer than 1 in 100 people): • acne 
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): • akne
Median time to first DE requiring substantial intervention 
PB, kjer je bilo potrebno bistveno posredovanje
Adults and adolescents (16 years of age and above) 
Odrasli in mladostniki (stari 16 let in več)
Treat each affected region of your skin until the eczema has gone away. 
Prizadete predele kože zdravite, dokler ekcem ne izgine.
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.
Protopic contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes. 
Zdravilo Protopic vsebuje butilhidroksitoluen (E321), ki lahko povzroči lokalne kožne reakcije (npr. kontaktni dermatitis) ali draženje oči in mukoznih membran.
Children (2 years of age and above) 
Otroci (stari 2 leti in več)
Between applications there should be 2-3 days without Protopic treatment. 
Med eno in drugo uporabo zdravila morajo miniti 2 do 3 dnevi brez uporabe zdravila Protopic.
Table 1: Efficacy at month 3 
Preglednica 1: Učinkovitost po 3 mesecih
• local skin infection regardless of specific cause including but not limited to: inflamed or infected hair follicles, cold sores, generalised herpes simplex infections 
• 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.
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.
Tacrolimus 0.1% (N=487) 
Takrolimus 0,1% (N=487)