FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 24-month dermal carcinogenicity study performed in mice with 0.1% ointment, no skin tumours were observed.
Slovenian: V 24-mesečni raziskavi dermalne kancerogenosti pri miših, opravljeni z 0,1% mazilom, niso opazili tumorjev kože.
English: Like all medicines, Protopy can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Protopy neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Protopy may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees.
Slovenian: Protopy se lahko uporablja na večini delov telesa, tudi na obrazu, vratu in v komolčnih in kolenskih
English: 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.
Slovenian: 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').
English: Protopy ointment is administered topically and is unlikely to have an effect on the ability to drive or use machines.
Slovenian: Protopy mazilo se uporablja lokalno, zato ni verjetno, da bi imelo kakšen vpliv na sposobnost vožnje in upravljanja s stroji.
English: Edifício Cinema Rua José Fontana, n.°1, 1°Andar P-2770-101 Paço de Arcos Tel: +351 21 4401320
Slovenian: Rua José Fontana, n.°1, 1°Andar P-2770-101 Paço de Arcos Tel: +351 21 4401320
English: The effect of treatment with Protopy 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).
Slovenian: Učinek zdravljenja z mazilom Protopy na razvijajoči se imunski sistem otrok, posebno mlajših, ni ugotovljen; to je treba upoštevati, kadar se zdravilo predpisuje v tej starostni skupini (glejte
English: The overall incidence of adverse events tended to decrease as the study progressed for all patients independent of age.
Slovenian: Celotna incidenca neželenih učinkov se je med potekom raziskave zmanjševaal pri vseh bolnikih, ne glede na starost.
English: Avoid exposing the skin to long periods of sunlight or artificial sunlight such as tanning beds.
Slovenian: Kože ne smete dolgo časa izpostavljati sončni svetlobi ali umetni sončni svetlobi, npr. v solarijih.
English: D-81673 München
Slovenian: D-81673 München Nemčija
English: If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Protopy or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).
Slovenian: Če ste alergični na (preobčutljivi za) takrolimus ali katerokoli sestavino zdravila Protopy ali na makrolidne antibiotike (npr. azitromicin, klaritromicin, eritromicin).
English: 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.
Slovenian: 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.
English: Burning sensation and itching are very common (> 10%).
Slovenian: Zelo pogosti so pekoč občutek, srbenje in pordelost (> 10%).
English: Usually, treatment is started with Protopy 0.1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared.
Slovenian: Zdravljenje se ponavadi začne z mazilom Protopy 0,1% dvakrat na dan, enkrat zjutraj in enkrat zvečer, dokler ekcem ne izgine.
English: Before receiving a vaccination tell your doctor that you are using Protopy (see Section “Take special care with Protopy”).
Slovenian: Preden dobite kakšno cepivo, zdravniku povejte, da uporabljate Protopy (glejte poglavje "Bodite posebno pozorni pri uporabi zdravila Protopy").
English: Based on changes from baseline in EASI score and body surface area affected, patients regardless of age had improvement in their atopic dermatitis at all subsequent time points.
Slovenian: Na podlagi sprememb seštevka EASI v primerjavi z izhodiščem in na podlagi sprememb prizadetega območja telesne površine se je v zaporednih časovnih točkah atopični dermatitis izboljšal vsem bolnikom, ne glede na starost.
English: WHAT PROTOPY IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO PROTOPY IN ZA KAJ GA UPORABLJAMO
English: The safety of Protopy ointment has not been established in patients with generalised erythroderma.
Slovenian: Varnost mazila Protopy ni ugotovljena pri bolnikih z generalizirano eritrodermijo.
English: If you have an inherited skin barrier disease such as Netherton's syndrome or if you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire skin).
Slovenian: Če imate kakšno prirojeno bolezen kožne pregrade, npr. Nethertonov sindrom, ali generalizirano eritrodermijo (vnetno pordelost in luščenje celotne kože).
English: Protopy ointment should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Protopy ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: Median mEASI as Percentage of Baseline mean AUC (Primary Endpoint)§
Slovenian: Mediani mEASI kot odstotek izhodiščne povprečne AUC (primarna končna točka)§
English: Hypersensitivity to macrolides in general, to tacrolimus or to any of the excipients.
Slovenian: Preobčutljivost za makrolide na splošno, za takrolimus ali katerokoli pomožno snov.
English: A potential interaction between vaccination and application of Protopy ointment has not been investigated.
Slovenian: Morebitne interacije med cepivi in uporabo mazila Protopy niso raziskane.
English: In both adults and children with an average of 50% body surface area treated, systemic exposure (i.e. AUC) of tacrolimus from Protopy is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
Slovenian: Tako pri odraslih kot pri otrocih s povprečno 50% zdravljene telesne površine je sistemska izpostavljenost (tj. AUC) takrolimusa iz Protopya približno 30-krat manjša kot po peroralnih imunosupresivnih odmerkih pri bolnikih s presajenimi ledvicami ali jetri.
English: Care should be exercised if applying Protopy to patients with extensive skin involvement over an extended period of time, especially in children (see section 4.2).
Slovenian: Previdnost je potrebna, če Protopy za dalj časa predpišete bolnikom z obsežno prizadetostjo kože, zlasti otrokom (glejte poglavje 4.2).
English: Patients may be at an increased risk of folliculitis, acne and herpes viral infections.
Slovenian: Bolnike lahko bolj ogrožajo folikulitis, akne in herpesvirusne okužbe.
English: The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period.
Slovenian: Primarna končna točka je bila površina pod krivuljo (AUC) mEASI kot odstotek izhodiščnega, povprečen glede na obdobje zdravljenja.
English: 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 Protopy ointment (see section 5.3).
Slovenian: Izpostavljenost kože sončni svetlobi je treba omejiti na najmanjšo mero; med zdravljenjem z mazilom Protopy se je treba izogibati uporabi ultravijolične (UV) svetlobe v solarijih in zdravljenju z UVB ali UVA v kombinaciji s psoraleni (PUVA) (glejte poglavje 5.3).
English: Wash your hands after applying Protopy unless your hands are also being treated.
Slovenian: Potem, ko ste nanesli Protopy, si umijte roke, razen če si zdravite tudi roke.
English: The primary endpoint was defined as the percentage decrease in mEASI from the baseline to end of treatment.
Slovenian: Primarna končna točka je bila opredeljena kot odstotek zmanjšanja mEASI od izhodišča do konca zdravljenja.
English: If the ointment gets on any of these areas, it should be thoroughly wiped off and/or rinsed off with water.
Slovenian: Če pride mazilo na katerega od teh predelov, ga morate z njega temeljito obrisati in/ali splakniti z vodo.
English: If symptoms reappear, treatment with Protopy 0.1% twice a day should be restarted.
Slovenian: Če se simptomi znova pojavijo, je ponovno treba začeti zdravljenje s Protopyom 0,1% dvakrat na dan.
English: Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment.
Slovenian: Pekoč občutek in srbenje sta bila zelo pogosta, ponavadi blaga do zmerna in sta praviloma izzvenela v enem tednu po začetku zdravljenja.
English: Before receiving a vaccination tell your doctor that you are using Protopy.
Slovenian: Preden dobite kakšno cepivo, zdravniku povejte, da uporabljate Protopy.
English: Uncommon:
Slovenian: Pogosti:
English: Protopy ointment is not approved for children younger than 2 years of age.
Slovenian: Bodite posebno pozorni pri uporabi zdravila Protopy Protopy ni odobren za otroke, mlajše od 2 let.
English: A very small number of people who have used Protopy ointment have had malignancies (for example, skin or lymphoma).
Slovenian: Zelo maloštevilni bolniki, ki so uporabljali mazilo Protopy, so imeli malignome (npr. na koži ali limfom).
English: Afterwards the ointment should be used once a day on each affected region of the skin until the eczema has gone away.
Slovenian: Potem je treba mazilo na prizadetem predelu kože uporabljati enkrat na dan, dokler ekcem ne izgine.
English: The use of Protopy ointment under occlusion has not been studied in patients.
Slovenian: Uporaba mazila Protopy pod okluzijo pri bolnikih ni raziskana.
English: Do not cover the skin being treated with bandages or wraps.
Slovenian: Zdravljene kože ne prekrivajte s povoji ali kako drugače.
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, pordelost, suhost).
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: 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).
English: Clinical data have shown that tacrolimus concentrations in systemic circulation after topical administration are low and, when measurable, transient.
Slovenian: Klinični podatki kažejo, da je koncentracija takrolimusa v sistemskem obtoku po lokalni uporabi majhna in da je v primerih, ko je merljiva, prehodna.
English: For live attenuated vaccinations (e.g. measles, mumps, rubella or oral polio) the waiting time is 28 days, for inactivated vaccines (e.g. tetanus, diphtheria, pertussis or influenza) 14 days.
Slovenian: Z živimi atenuiranimi cepivi (npr. proti ošpicam, mumpsu, rdečkam in peroralnim proti poliu) je treba počakati 28 dni, z inaktiviranimi cepivi (npr. proti tetanusu, davici, oslovskemu kašlju ali gripi) pa 14 dni.
English: Twice daily treatment with 0.03% tacrolimus ointment was more effective than once daily administration (Table 3).
Slovenian: Zdravljenje z 0,03% mazilom s takrolimusom dvakrat na dan je bilo učinkovitejše kot uporaba enkrat na dan (tabela 3).
English: Transplant patients receiving immunosuppressive regimens (e.g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore patients who receive Protopy 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 Protopy in se jim pojavi limfadenopatija, spremljati, da bi se prepričali o njenem izginotju.
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 (0.03%) had blood concentrations < 1.0 ng/ml.
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 zdravljenih z mazilom s takrolimusom (0,03%), je bila koncentracija v krvi < 1,0 ng/ml.
English: Protopy should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression.
Slovenian: Protopya ne smete uporabljati pri bolnikih s prirojeno ali pridobljeno imunsko pomanjkljivostjo in bolnikih, ki prejemajo imunosupresivno terapijo.
English: Other common (> 1%) side effects are redness, feeling of warmth, pain, increased skin sensitivity (especially to hot and cold), skin tingling, rash, folliculitis (inflamed or infected hair follicles) and herpes viral infections (e.g. cold sores, generalised herpes simplex infections).
Slovenian: Drugi pogosti (> 1%) neželeni učinki so pordelost, občutek toplote, bolečina, zvečana občutljivost kože (zlasti za vročino in mraz), mravljinčenje na koži, izpuščaj, folikulitis (vnetje ali okužbe mešičkov dlak) in herpesvirusne okužbe (npr. ocvirki, razširjene okužbe s herpes simplex).
English: If you have infected lesions.
Slovenian: Če so spremembe na koži okužene.
English: The use of Protopy ointment in patients with genetic epidermal barrier defects such as Netherton's syndrome is not recommended due to the potential for permanently increased systemic absorption of tacrolimus.
Slovenian: Mazila Protopy ni priporočljivo uporabljati pri bolnikih z genetskimi okvarami epidermalne pregrade, npr. pri bolnikih z Nethertonovim sindromom, ker obstaja možnost trajno zvečane sistemske absorpcije takrolimusa.
English: Adults (16 years of age and older)
Slovenian: Odrasli (16 let in starejši)
English: Do not apply the ointment to infected lesions.
Slovenian: Mazila ne nanašajte na okužene spremembe.
English: 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.
Slovenian: 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.
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 (tabela 2).
English: The three most common adverse events reported were flu-like symptoms (cold, common cold, influenza, upper respiratory infection, etc.), pruritus and skin burning.
Slovenian: Trije najpogosteje opisani neželeni učinki so bili gripi podobni simptomi (prehlad, nahod, influenca okužba zgornjih dihal itn.), srbenje in pekoč občutek na koži.
English: If you have liver failure.
Slovenian: Če imate odpoved jeter.
English: Herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption)
Slovenian: Herpesvirusne okužbe (herpes simplex dermatitis [eczema herpeticum], herpes simplex [ocvirki], Kaposijev variceliformni izpuščaj)
English: 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).
Slovenian: 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).
English: Mutagenicity In vitro and in vivo tests did not indicate a genotoxic potential of tacrolimus.
Slovenian: Preizkusi in vitro in in vivo niso pokazali, da bi imel takrolimus genotoksičen potencial.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika
English: Protopy ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Slovenian: Učinkovitost in varnost mazila Protopy nista raziskani za zdravljenje atopičnega dermatitisa, ki je klinično okužen.
English: Protopy alters the abnormal immune response and relieves the skin inflammation and the itch.
Slovenian: Protopy spremeni nenormalen imunski odziv in odpravi vnetje in srbenje kože.
English: Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap.
Slovenian: Laminatna tuba z notranjo prevleko iz polietilena majhne gostote, opremljena z belo polipropilensko
English: If your lymph nodes become swollen during treatment with Protopy, consult your doctor.
Slovenian: Če vam med zdravljenjem s Protopyom otečejo bezgavke, se posvetujte z zdravnikom.
English: Treatment with Protopy may be associated with an increased risk of herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption).
Slovenian: Zdravljenje s Protopyom lahko spremlja večje tveganje za herpesvirusne okužbe (herpes simplex dermatitis [eczema herpeticum], herpes simplex [ocvirki], Kaposijev variceliformni izpuščaj).
English: Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopy ointment is not recommended.
Slovenian: Čeprav je sistemska izpostavljenost po uporabi mazila s takrolimusom glede na klinične podatke majhna, dojenje med zdravljenjem z mazilom Protopy ni priporočljivo.
English: Patients with atopic dermatitis treated with Protopy have not been found to have significant systemic tacrolimus levels.
Slovenian: Pri bolnikih z atopičnim dermatitisom, ki dobivajo Protopy, niso ugotovili pomembne sistemske koncentracije takrolimusa.
English: You should inform your doctor if you have swollen lymph nodes at initiation of treatment.
Slovenian: Zdravniku morate povedati, če imate na začetku zdravljenja otekle bezgavke.
English: 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.
Slovenian: Pri bolnikih s presadki je dolgotrajno sistemsko izpostavljenost intenzivni imunosupresiji, po sistemski uporabi zaviralcev kalcinevrina, spremljalo večje tveganje za limfome in malignome na koži.
English: Treatment should be started with Protopy 0.1% twice a day and treatment should be continued until clearance of the lesion.
Slovenian: Zdravljenje je treba začeti s Protopyom 0,1% dvakrat na dan in ga nadaljevati, dokler spremembe ne izginejo.
English: Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk.
Slovenian: Podatki pri ljudeh kažejo, da se takrolimus po sistemski uporabi izloča v materinem mleku.
English: Avoid contact with the eyes or mucous membranes (inside of your nose or mouth).
Slovenian: Pazite, da zdravilo ne pride v oči ali na sluznice (v nosu ali ustih).
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 CYP3A4.
English: The potential risk for humans is unknown.
Slovenian: Možno tveganje za ljudi
English: However, a link to Protopy ointment treatment has not been confirmed or refuted on the available evidence so far.
Slovenian: Vendar povezave z uporabo mazila Protopy na podlagi dosedanjih ugotovitev niso niti potrdili niti ovrgli.
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: Approximately half of the patients who use Protopy have some type of skin irritation where they have applied the ointment.
Slovenian: Približno polovica bolnikov, ki uporabljajo Protopy, občuti neko vrsto draženja kože na mestu nanosa mazila.
English: The active substance of Protopy, tacrolimus monohydrate, is an immunomodulating agent.
Slovenian: Zdravilna učinkovina Protopya, takrolimus monohidrat, je imunomodulacijsko sredstvo.
English: Sensation of warmth, pain, paraesthesia and rash at the site of application were also commonly observed.
Slovenian: Pogosto so opažali občutek toplote, bolečine, parestezije in izpuščaj na mestu uporabe.
English: Use in elderly (65 years of age and above)
Slovenian: Uporaba pri starejših (65 let in več)
English: Children (2 years of age and older)
Slovenian: Otroci (stari 2 leti in več)
English: Do not use Protopy after the expiry date which is stated on the tube and carton after EXP.
Slovenian: Zdravila Protopy ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na tubi in škatli poleg oznake »Uporabno do:«.
English: Each affected region of the skin should be treated with Protopy until clearance occurs and then treatment should be discontinued.
Slovenian: Prizadeti predel kože je treba s Protopyom zdraviti, dokler spremembe ne izginejo.
English: In this leaflet:
Slovenian: Občasni:
English: Protopy ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes.
Slovenian: Protopy mazilo se lahko uporabi povsod na telesu, tudi na obrazu, vratu in v fleksurah, ne pa na sluznicah.
English: Tacrolimus 0.03% Twice daily (N=210)
Slovenian: Takrolimus 0,03% Dvakrat na dan (N=210)
English: Due to the nature of the ointment vehicle, induction of vomiting or gastric lavage is not recommended.
Slovenian: Zaradi narave vehikla mazila ni priporočljivo sprožati
English: Vaccinations should not be given during treatment and for a certain time after treatment with Protopy.
Slovenian: Med zdravljenjem s Protopyom in določen čas po zdravljenju ne smete dobiti cepiv.
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/001
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/02/202/001
English: However, a link to Protopy ointment treatment has not been shown.
Slovenian: Vendar ni dokazano, da bi bilo to povezano z zdravljenjem z mazilom Protopy.
English: What Protopy contains
Slovenian: Kaj vsebuje zdravilo Protopy