FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 4: Efficacy (moderate to severe subpopulation)
Croatian: Tablica 4: Djelotvornost (podpopulacija s umjerenom do teškom bolešću)
English: • Do not cover the skin being treated with bandages or wraps.
Croatian: • Nemojte prekrivati kožu koju liječite povojima ili zavojima.
English: Sensation of warmth, pain, paraesthesia and rash at the site of application were also commonly observed.
Croatian: Osjećaj topline, bola, parestezije i osipa na mjestu primjene također su bili često zabilježeni.
English: In animals, tacrolimus ointment suppressed inflammatory reactions in experimental and spontaneous dermatitis models that resemble human atopic dermatitis.
Croatian: U životinja je takrolimus mast potisnula upalne reakcije u modelima eksperimentalnog i spontanog dermatitisa koji nalikuju atopijskom dermatitisu u ljudi.
English: The lowest tacrolimus blood concentration at which systemic effects can be observed is not known.
Croatian: Najniža koncentracija takrolimusa u krvi pri kojoj se mogu opaziti sistemski učinci nije poznata.
English: Afterwards the frequency of application should be reduced to once a day until clearance of the lesion (see section 4.4).
Croatian: Nakon toga, potrebno je smanjiti učestalost primjene na samo jedanput na dan do nestanka lezija (vidjeti dio 4.4).
English: If ingested, general supportive measures may be appropriate.
Croatian: Ako se proguta, prikladno je uvesti opće potporne mjere.
English: Butylhydroxytoluene (E321) 15 micrograms/g ointment.
Croatian: Butilhidroksitoluen (E321) 15 mikrograma/g mast.
English: If you accidentally swallow some ointment
Croatian: Ako slučajno progutate mast
English: Lymphadenopathy present at initiation of therapy should be investigated and kept under review.
Croatian: Limfadenopatiju prisutnu na početku terapije treba ispitati i držati pod nadzorom.
English: Protopic ointment should not be used in children aged below 2 years until further data are available.
Croatian: Protopic mast ne smije se primjenjivati u djece u dobi ispod 2 godine prije nego što dodatni podaci ne postanu dostupni.
English: Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous interactions that could affect the metabolism of tacrolimus.
Croatian: Takrolimus se ne metabolizira u ljudskoj koži, što pokazuje da ne postoji mogućnost nastanka perkutanih interkacija koje bi mogle utjecati na metabolizam takrolimusa.
English: What Protopic is and what it is used for What you need to know before you use Protopic How to use Protopic
Croatian: Što je Protopic i za što se koristi Što morate znati prije nego počnete primjenjivati Protopic Kako primjenjivati Protopic
English: If no signs of improvement are seen after two weeks of treatment, further treatment options should be considered.
Croatian: Ako se nakon dva tjedna liječenja ne vide znakovi poboljšanja, potrebno je razmotriti daljnje mogućnosti liječenja.
English: • 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.
Croatian: • Ako Vam liječnik kaže da primjenjujete Protopic dvaput tjedno kako Vam se atopijski dermatitis ne bi rasplamsao, liječnik Vas mora pregledati najmanje svakih 12 mjeseci, čak i ako je bolest pod kontrolom.
English: Do not apply the ointment to infected lesions.
Croatian: Nemojte nanositi mast na inficirane lezije.
English: 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).
Croatian: Farmakokinetika takrolimusa nakon topikalne primjene slična je onoj zabilježenoj u odraslih, uz minimalnu sistemsku izloženost i bez dokazanog nakupljanja (vidjeti gore).
English: • If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6) or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).
Croatian: • ako ste alergični na takrolimus ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ili na makrolidne antibiotike (npr. azitromicin, klaritromicin, eritromicin).
English: Topical corticosteroid regimen§ (N=485)
Croatian: Režim topikalnih kortikosteroida§ (N = 485)
English: Lymphadenopathy was uncommonly (0.8%) reported in clinical trials.
Croatian: Limfadenopatija nije bila često (0,8%) zabilježena u kliničkim ispitivanjima.
English: Paediatric population Frequency, type and severity of adverse reactions in children are similar to those reported in adults.
Croatian: Učestalost, vrsta i težina nuspojava u djece slične su onima zabilježenima u odraslih.
English: 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).
Croatian: Učinak liječenja Protopic mašću na razvoj imunološkog sustava u djece ispod 2 godine starosti nije ustanovljen (vidjeti dio 4.1).
English: • Protopic may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees.
Croatian: • Protopic se može primijeniti na većinu dijelova tijela, uključujući lice i vrat te pregibe lakta i koljena.
English: • The safety of using Protopic for a long time is not known.
Croatian: • Sigurnost primjene Protopic masti tijekom dugog razdoblja nije poznata.
English: Do not use this medicine after the expiry date which is stated on the tube and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na tubi i kutiji iza oznake „EXP“.
English: The primary response to vaccination was not affected.
Croatian: Primarni odgovor na cijepljenje nije bio promijenjen.
English: Protopic ointment has no or negligible influence on the ability to drive and use machines.
Croatian: Protopic mast ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Analysis of the response rate at week 5 showed equivalence between the treatment groups (hydrocortisone 98.3%, tacrolimus ointment 95.4%; 7-11 years: 100% in both arms).
Croatian: Analiza stope odgovora u 5. tjednu pokazala je sličnost u obje terapijske skupine (hidrokortizon 98,3%, takrolimus mast 95,4%; 7-11 godina: 100% u obje skupine).
English: The three most common adverse events reported were flu-like symptoms (cold, common cold, influenza, upper respiratory infection, etc.), pruritus and skin burning.
Croatian: Tri najčešće zabilježene nuspojave bile su simptomi nalik gripi (prehlada, obična prehlada, influenca, infekcija gornjih dišnih puteva, itd.), svrbež i žarenje kože.
English: Care should be taken to avoid contact with eyes and mucous membranes.
Croatian: Potrebno je izbjegavati kontakt s očima i sluznicama.
English: After 12 months this evaluation should include suspension of Protopic treatment in paediatric patients (see section 4.2).
Croatian: Nakon 12 mjeseci, ti pregledi trebaju uključiti obustavu liječenja Protopic mašću u pedijatrijskih bolesnika (vidjeti dio 4.2).
English: These symptoms are usually mild to moderate and generally go away within one week of using Protopic.
Croatian: Ovi su simptomi obično blagi do umjereni i općenito nestaju u roku od tjedan dana primjene Protopic masti.
English: Concomitant use of other topical preparations has not been assessed.
Croatian: Nije procijenjena istovremena primjena drugih topikalnih preparata.
English: Hypersensitivity to the active substance, macrolides in general, or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, makrolide općenito ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known.
Croatian: Primijećeno je sljedeće, ali nije poznato koji je klinički značaj tih opažanja u atopijskom dermatitisu.
English: If you spend time outdoors after applying Protopic, use a sunscreen and wear loose fitting clothing that protects the skin from the sun.
Croatian: Ako ćete boraviti na otvorenom prostoru nakon primjene Protopic masti, primijenite pripravak za zaštitu od sunca i nosite široku, udobnu odjeću koja štiti kožu od sunca.
English: After 12 months treatment, a review of the patient`s condition should be conducted by the physician and a decision taken whether to continue maintenance treatment in the absence of safety data for maintenance treatment beyond 12 months.
Croatian: Nakon 12 mjeseci liječenja, liječnik treba provjeriti stanje bolesnika i donijeti odluku o tome hoće li se nastaviti terapija održavanja s obzirom na to da nema podataka o sigurnosti liječenja u trajanju duljem od 12 mjeseci.
English: • If you have any skin malignancies (tumours) or if you have a weakened immune system (immuno-compromised) whatever the cause.
Croatian: • ako imate bilo kakvu zloćudnu bolest kože (tumore) ili imate oslabljen imunološki sustav (imunokompromitirani) zbog bilo kojeg uzroka.
English: If symptoms reappear you should use Protopic twice daily as outlined above and arrange to see your doctor to review your treatment.
Croatian: Ako se simptomi ponovno pojave, trebate primjenjivati Protopic dvaput na dan kako je opisano gore i dogovoriti posjet liječniku da provjeri kako napreduje liječenje.
English: Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression.
Croatian: Protopic se ne smije primjenjivati u bolesnika s urođenom ili stečenom imunodeficijencijom ili u bolesnika na terapiji koja uzrokuje imunosupresiju.
English: However, both the extent and the rate of topical absorption of tacrolimus decrease as the skin heals.
Croatian: Međutim, količina i brzina apsorpcije topikalnog takrolimusa smanjuju se kako koža cijeli.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: U svakoj skupini učestalosti, nuspojave su navedene slijedom prema sve manjoj ozbiljnosti.
English: You may use moisturising creams and lotions during treatment with Protopic but these products should not be used within two hours of applying Protopic.
Croatian: Možete primjenjivati vlažne kreme i losione tijekom liječenja Protopic mašću, ali ti se proizvodi ne smiju nanositi dva sata nakon nanošenja Protopic masti.
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.
Croatian: Međutim, mogućnost interakcija ne može se isključiti pa je potreban oprez kod istovremene sistemske primjene poznatih inhibitora CYP3A4 (npr. eritromicina, itrakonazola, ketokonazola i diltiazema) u bolesnika s proširenom i/ili eritrodermatoznom bolešću.
English: In the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopic should be considered.
Croatian: U odsutnosti jasnog uzroka limfadenopatije ili u prisutnosti akutne infektivne mononukleoze, potrebno je razmotriti prekid liječenja Protopic mašću.
English: In a study of maintenance treatment (twice weekly treatment) in adults and children with moderate and severe atopic dermatitis the following adverse events were noted to occur more frequently than in the control group: application site impetigo (7.7% in children) and application site infections (6.4% in children and 6.3% in adults).
Croatian: U ispitivanju terapije održavanja (liječenje dvaput tjedno) u odraslih i djece s umjerenim i teškim atopijskim dermatitisom, zabilježeno je da se sljedeće nuspojave pojavljuju češće nego u kontrolnoj skupini: impetigo na mjestu primjene (7,7% u djece) i infekcije na mjestu primjene (6,4% u djece i 6,3% u odraslih).
English: If you forget to use Protopic
Croatian: Ako ste zaboravili primijeniti Protopic
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.
Croatian: Na temelju promjene EASI rezultata u odnosu na početnu vrijednost i površinu tijela, bolesnici su bez obzira na dob imali poboljšanje atopijskog dermatitisa u svim daljnjim vremenskim točkama.
English: In vitro, in Langerhans cells isolated from normal human skin, tacrolimus reduced the stimulatory activity towards T cells.
Croatian: In vitro, u Langerhansovim stanicama izoliranim iz normalne ljudske kože, takrolimus je smanjio stimulacijsko djelovanje na T stanice.
English: In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness, dryness).
Croatian: U atopijskom dermatitisu, pretjerana reakcija imunološkog sustava kože uzrokuje upalu kože (svrbež, crvenilo, suhoću).
English: Long-term topical treatment of rats with tacrolimus led to systemic toxicity including alterations of kidneys, pancreas, eyes and nervous system.
Croatian: Dugotrajno topikalno liječenje štakora takrolimusom dovelo je do sistemske toksičnosti uključujući promjene na bubrezima, gušterači, očima i živčanom sustavu.
English: No effect on immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity has been observed (see section 5.1).
Croatian: Nije opažen utjecaj na neposredni odgovor na cijepljenje, na stvaranje imunološkog pamćenja ili humoralne ili stanične imunosti (vidjeti dio 5.1).
English: Embryo/foetal toxicity was observed in rats and rabbits, but only at doses that caused significant toxicity in maternal animals.
Croatian: Embrio-fetalna toksičnost opažena je u štakora i kunića, ali samo pri dozama koje su uzrokovale značajnu toksičnost u ženki.
English: Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant.
Croatian: Protopic mast ne smije se nanositi na lezije koje se smatraju potencijalno zloćudnima ili prekancerozama.
English: The changes were caused by high systemic exposure of rodents resulting from high transdermal absorption of tacrolimus.
Croatian: Te su promjene bile uzrokovane visokom sistemskom izloženošću glodavaca koja je bila posljedica visoke transdermalne apsorpcije takrolimusa.
English: In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application.
Croatian: U kliničkim je ispitivanjima približno 50% bolesnika imalo neku vrstu nuspojave u obliku nadraženosti kože na mjestu primjene.
English: Rabbits were shown to be especially sensitive to intravenous administration of tacrolimus, reversible cardiotoxic effects being observed.
Croatian: Pokazalo se da su kunići osobito osjetljivi na intravensku primjenu takrolimusa, s obzirom na to da su opaženi reverzibilni kardiotoksični učinci.
English: 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.
Croatian: Primarni ishod u oba ispitivanja bio je broj egzacerbacija bolesti koje su zahtijevale „znatnu terapijsku intervenciju“ tijekom DCP, a bile su definirane kao egzacerbacije s rezultatom na IGA ljestvici od 3 do 5 (tj. umjerena, teška ili jako teška bolest) prvog dana rasplamsavanja bolesti i koju je bilo potrebno liječiti dulje od 7 dana.
English: 217 days
Croatian: 217 dana
English: In a 24-month dermal carcinogenicity study performed in mice with 0.1% ointment, no skin tumours were observed.
Croatian: U ispitivanju kožne kancerogenosti u trajanju od 24 mjeseca provedenom u miševa pomoću 0,1%-tne masti nisu opaženi kožni tumori.
English: The risk for humans cannot be completely ruled out as the potential for local immunosuppression with the long-term use of tacrolimus ointment is unknown.
Croatian: Rizik za ljude ne može se potpuno isključiti jer nije poznato postoji li mogućnost lokalne imunosupresije kod dugotrajne primjene takrolimus masti.
English: Via its binding to a specific cytoplasmic immunophilin (FKBP12), tacrolimus inhibits calciumdependent signal transduction pathways in T cells, thereby preventing the transcription and synthesis of IL-2, IL-3, IL-4, IL-5 and other cytokines such as GM-CSF, TNF-α and IFN-γ.
Croatian: Vezanjem za poseban citoplazmatski imunofilin (FKBP12) takrolimus inhibira puteve prijenosa signala u T stanicama koji ovise o kalciju i tako sprječava transkripciju i sintezu IL-2, IL-3, IL-4, IL-5
English: • 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).
Croatian: • ako imate nasljednu bolest kožne barijere kao što je Nethertonov sindrom, lamelarna ihtioza (opsežno ljuštenje kože zbog zadebljanja vanjskog sloja kože) ili ako bolujete od generalizirane eritroderme (upalno crvenilo i ljuštenje cijele kože).
English: Elderly Specific studies have not been conducted in older people (see flare treatment section above).
Croatian: Starije osobe Nisu provedena posebna ispitivanja u starijih osoba (vidjeti dio o liječenju rasplamsane bolesti, gore).
English: 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.
Croatian: Ovisno o odgovoru ekcema, liječnik će odlučiti može li se smanjiti učestalost nanošenja ili može li se nanositi manja jačina, Protopic 0,03% mast.
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.
Croatian: Podaci prikupljeni u zdravih ispitanika pokazuju da nema ili gotovo nema sistemske izloženosti takrolimusu nakon jednokratne ili ponovljene topikalne primjene takrolimus masti.
English: Before commencing treatment with Protopic ointment, clinical infections at treatment sites should be cleared.
Croatian: Prije početka liječenja Protopic mašću, potrebno je izliječiti kliničke infekcije na liječenim područjima.
English: Protopic ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes.
Croatian: Protopic mast može se primijeniti na bilo koji dio tijela, uključujući lice, vrat i područja pregiba, osim na sluznice.
English: Protopic contains butylhydroxytoluene (E321)
Croatian: Protopic sadrži butilhidroksitoluen (E321)
English: Patients with atopic dermatitis are predisposed to superficial skin infections.
Croatian: Bolesnici s atopijskim dermatitisom skloni su površinskim infekcijama kože.
English: 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).
Croatian: Liječenje Protopic mašću može biti povezano s povećanim rizikom od folikulitisa i infekcija herpes virusom (herpes simpleks dermatitis [herpetički ekcem], herpes simpleks [groznica], Kaposijeva varičeliformna erupcija) (vidjeti dio 4.8).
English: If the ointment gets on any of these areas, it should be thoroughly wiped off and/or rinsed off with water.
Croatian: Ako mast dospije u ta područja, temeljito je obrišite i/ili isperite vodom.
English: Protopic 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years.
Croatian: Protopic 0,03% mast indicirana je u odraslih, adolescenata i djece u dobi od 2 godine.
English: • If you have a cutaneous Graft Versus Host Disease (an immune reaction of the skin which is a common complication in patients who have undergone a bone marrow transplant).
Croatian: • ako imate kožni oblik bolesti presatka protiv primatelja (imunološka reakcija kože koja je česta komplikacija u bolesnika kojima je presađena koštana srž).
English: Tacrolimus ointment does not affect collagen synthesis in humans.
Croatian: Takrolimus mast ne utječe na sintezu kolagena u ljudi.
English: There is no experience with concomitant use of systemic steroids or immunosuppressive agents.
Croatian: Ne postoji iskustvo s istovremenom primjenom sistemskih kortikosteroida ili imunosupresivnih lijekova.
English: • Wash your hands after applying Protopic unless your hands are also being treated.
Croatian: • Nakon nanošenja Protopic masti operite ruke, osim ako ne liječite i ruke.
English: • local skin infection regardless of specific cause including but not limited to: inflamed or infected hair follicles, cold sores, generalised herpes simplex infections
Croatian: • lokalna kožna infekcija bez obzira na specifičan uzrok uključujući, između ostaloga: upalu ili infekciju folikula dlake, groznicu na usnama, generaliziranu infekciju herpes simpleksom
English: Thereafter, patients entered a double-blind disease control period (DCP) for up to 12 months.
Croatian: Nakon toga, bolesnici su ušli u dvostruko slijepo razdoblje kontrole bolesti (DCP; engl.
English: The potential for local immunosuppression (possibly resulting in infections or cutaneous malignancies) in the long term (i.e. over a period of years) is unknown (see section 5.1).
Croatian: Nije poznato kolika je mogućnost lokalne imunosupresije (koja bi mogla rezultirati infekcijama ili zloćudnim bolestima kože) kod dugotrajne primjene (tj. tijekom godina) (vidjeti dio 5.1).
English: Protopic contains the active substance tacrolimus, a calcineurin inhibitor.
Croatian: Protopic sadrži djelatnu tvar takrolimus, inhibitor kalcineurina.
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).
Croatian: Takrolimus se opsežno metabolizira u jetri pa, iako su koncentracije u krvi nakon topikalne terapije niske, mast je potrebno primjenjivati s oprezom u bolesnika sa zatajenjem jetre (vidjeti dio 5.2).
English: In the same study an increased incidence of lymphoma was detected in association with high systemic exposure.
Croatian: U istom ispitivanju otkrivena je povećana incidencija limfoma povezana s visokom sistemskom izloženošću.
English: Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment.
Croatian: Žarenje i svrbež bili su vrlo česti, obično blage do umjerene težine i uglavnom su se povlačili u roku od jednog tjedna od početka liječenja.
English: Patients may be at an increased risk of folliculitis, acne and herpes viral infections.
Croatian: Bolesnici mogu imati povećan rizik od folikulitisa, akni i infekcija herpes virusom.
English: 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.
Croatian: Oba su ispitivanja pokazala značajnu korist kod liječenja takrolimus mašću dvaput tjedno s obzirom na primarne i ključne sekundarne ishode tijekom razdoblja od 12 mjeseci u objedinjenoj populaciji bolesnika s blagim do teškim atopijskim dermatitisom.
English: Afterwards the ointment should be used once a day on each affected region of the skin until the eczema has gone away.
Croatian: Nakon toga mast treba nanositi jedanput na dan na svako zahvaćeno područje kože dok ekcem ne nestane.
English: Tacrolimus ointment did not reduce skin thickness and did not cause skin atrophy in animals.
Croatian: Takrolimus mast nije smanjio debljinu kože niti prouzročio atrofiju kože u životinja.
English: If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible.
Croatian: Ako slučajno progutate mast, čim prije potražite savjet liječnika ili ljekarnika.