FrancophonIA/ELRC3.0 huggingface dataset:
English: No adverse events previously unreported in shorter duration and/or previous studies were observed in this long-term study.
Croatian: U ovom dugotrajnom ispitivanju nisu bile opažene prethodno nezabilježene nuspojave kod kraće primjene i/ili u prethodnim ispitivanjima.
English: No adverse events not reported previously were observed in these studies.
Croatian: U ovim ispitivanjima nisu zabilježene nuspojave koje nisu prethodno bile zabilježene.
English: In children, maintenance treatment should be suspended after 12 months, to assess whether the need for continued treatment still exists.
Croatian: U djece, terapiju održavanja treba privremeno prekinuti nakon 12 mjeseci da bi se procijenilo je li potrebno nastaviti s liječenjem.
English: Tacrolimus has also been shown to inhibit the release of inflammatory mediators from skin mast cells, basophils and eosinophils.
Croatian: Također se pokazalo da takrolimus inhibira oslobađanje upalnih medijatora iz mastocita, bazofila i eozinofila u koži.
English: 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).
Croatian: Potreban je oprez ako se Protopic primjenjuje tijekom duljeg razdoblja u bolesnika u kojih je zahvaćena velika površina kože, osobito u djece (vidjeti dio 4.2).
English: Treat each affected region of your skin until the eczema has gone away.
Croatian: Liječite svako zahvaćeno područje kože sve dok ekcem ne nestane.
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo često (mogu se pojaviti u više od 1 na 10 korisnika):
English: • If you have swollen lymph nodes at initiation of treatment.
Croatian: • ako imate otečene limfne čvorove na početku liječenja.
English: Mutagenicity In vitro and in vivo tests did not indicate a genotoxic potential of tacrolimus.
Croatian: In vitro i in vivo testovi nisu pokazali da je takrolimus genotoksičan.
English: Metabolism of tacrolimus by human skin was not detectable.
Croatian: Metabolizam takrolimusa u ljudskoj koži nije bio mjerljiv.
English: Children • Protopic 0.1 % ointment is not approved for children younger than 16 years of age.
Croatian: • Protopic 0,1% mast nije odobrena za djecu mlađu od 16 godina.
English: If symptoms recur, twice daily treatment with Protopic 0.1% should be restarted.
Croatian: Ako se simptomi vrate, potrebno je ponovno započeti liječenje Protopic 0,1% mašću dvaput na dan.
English: There are no adequate data from the use of tacrolimus ointment in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni takrolimus masti u trudnica.
English: Drug level increased* (see section
Croatian: Pretrage povećana razina lijeka* (vidjeti dio
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva svrbež akne*
English: OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJA, AKO JE POTREBNO ROK VALJANOSTI
English: Protopic treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Croatian: Liječenje Protopic mašću treba započeti liječnik s iskustvom u dijagnosticiranju i liječenju atopijskog dermatitisa.
English: Twice daily treatment with 0.03% tacrolimus ointment was more effective than once daily administration (Table 3).
Croatian: Liječenje dvaput na dan mašću sa 0,03% takrolimusa bilo je djelotvornije nego primjena jedanput na dan (Tablica 3).
English: Protopic ointment should not be applied under occlusion because this method of administration has not been studied in patients (see section 4.4).
Croatian: Protopic mast ne smije se nanijeti ispod okluzivnog povoja zato što takav način primjene nije ispitan u bolesnika (vidjeti dio 4.4).
English: The efficacy and safety of Protopic was assessed in more than 18,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
Croatian: Djelotvornost i sigurnost Protopic masti bila je procijenjena u više od 18 500 bolesnika liječenih takrolimus mašću u kliničkim ispitivanjima, u fazama I do III.
English: 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.
Croatian: Iako su klinički podaci pokazali da je sistemska izloženost nakon primjene takrolimusa niska, ne preporučuje se dojiti tijekom liječenja Protopic mašću.
English: Clinical data have shown that tacrolimus concentrations in systemic circulation after topical administration are low and, when measurable, transient.
Croatian: Klinički su podaci pokazali da su koncentracije takrolimusa u sistemskoj cirkulaciji nakon topikalne primjene niske i prolazne, kad su mjerljive.
English: Following twice-weekly treatment application site infections have been reported in children and adults.
Croatian: Nakon liječenja primjenom dvaput tjedno zabilježene su infekcije na mjestu primjene u djece i odraslih.
English: Overdosage following topical administration is unlikely.
Croatian: Predoziranje nakon topikalne primjene nije vjerojatno.
English: Fertility There are no fertility data available.
Croatian: Nema dostupnih podataka o učincima na plodnost.
English: However, a link to Protopic ointment treatment has not been shown.
Croatian: Međutim, nije uočena povezanost s liječenjem Protopic mašću.
English: 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).
Croatian: Liječnik Vam može reći da primjenjujete Protopic mast dvaput tjedno nakon što Vam se atopijski dermatitis potpuno ili gotovo potpuno povuče (Protopic 0,03% za djecu i Protopic 0,1% za odrasle).
English: 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.
Croatian: Bolesnici koji odgovore na liječenje takrolimus mašću dvaput na dan u trajanju do najviše 6 tjedana (lezije nestale, gotovo nestale ili blago zahvaćaju kožu) pogodni su za terapiju održavanja.
English: The overall incidence of adverse events tended to decrease as the study progressed for all patients independent of age.
Croatian: Ukupna incidencija nuspojava postupno se smanjivala s trajanjem ispitivanja u svih bolesnika neovisno o njihovoj dobi.
English: 36 days
Croatian: 36 dana
English: If signs of a flare reoccur, twice daily treatment should be re-initiated (see flare treatment section above).
Croatian: Ako se ponovno pojave znakovi rasplamsavanja bolesti, potrebno je ponovno uvesti liječenje dvaput na dan (vidjeti dio o liječenju rasplamsane bolesti, gore).
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.
Croatian: U četvrtom je ispitivanju približno 800 bolesnika (starosti ≥ 2 godine) intermitentno ili kontinuirano primalo mast sa 0,1% takrolimusa u otvorenom, dugotrajnom ispitivanju sigurnosti u trajanju do četiri godine, s time da je 300 bolesnika primalo liječenje najmanje tri godine, a 79 bolesnika najmanje 42 mjeseca.
English: Protopic alters the abnormal immune response and relieves the skin inflammation and the itch.
Croatian: Protopic mijenja poremećeni imunološki odgovor i ublažava upalu kože i svrbež.
English: Apply Protopic 0.03 % ointment twice a day for up to three weeks, once in the morning and once in the evening.
Croatian: Nanesite Protopic 0,03% mast dvaput na dan tijekom najviše tri tjedna, jedanput ujutro i jedanput navečer.
English: You may be told by your doctor to use Protopic 0.1% ointment twice weekly once your atopic dermatitis has cleared or almost cleared.
Croatian: Liječnik Vam može reći da primjenjujete Protopic 0,1% mast dvaput tjedno nakon što Vam se atopijski dermatitis potpuno ili gotovo potpuno povuče.
English: Hydrocortisone acetate 1% (N=185)
Croatian: Hidrokortizon acetat 1% (N = 185)
English: • Apply Protopic as a thin layer to affected areas of your skin.
Croatian: • Nanesite Protopic u tankom sloju na zahvaćena područja kože.
English: Global Evaluation § Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck §§ higher values = greater improvement
Croatian: § Režim topikalnim kortikosteroidima = 0,1% hidrokortizon butirat za trup i ekstremitete, 1% hidrokortizon acetat za lice i vrat §§ više vrijednosti = veće poboljšanje
English: A very small number of people who have used Protopic ointment have had malignancies (for example, skin or lymphoma).
Croatian: Vrlo mali broj ljudi koji su primjenjivali Protopic mast imao je zloćudne bolesti (na primjer, kože ili limfnog tkiva).
English: If your lymph nodes become swollen during treatment with Protopic, consult your doctor.
Croatian: Ako Vam limfni čvorovi postanu otečeni tijekom liječenja Protopic masti, potražite savjet liječnika.
English: • Before applying Protopic after a bath or shower, be sure your skin is completely dry.
Croatian: • Nakon kupke ili tuširanja, pazite da Vam je koža potpuno suha prije nanošenja Protopic masti.
English: Table 1: Efficacy at month 3
Croatian: Tablica 1: Djelotvornost u 3. mjesecu
English: Common (may affect up to 1 in 10 people):
Croatian: Često (mogu se pojaviti u do 1 na 10 korisnika):
English: Uncommon (may affect fewer than 1 in 100 people): • acne
Croatian: Manje često (mogu se pojaviti u manje od 1 na 100 korisnika): • akne
English: Patients, particularly paediatric patients should be continuously evaluated during treatment with Protopic with respect to the response to treatment and the continuing need for treatment.
Croatian: Tijekom liječenja Protopic mašću potrebno je stalno pregledavati bolesnike, osobito pedijatrijske bolesnike, s obzirom na njihov odgovor na liječenje i potrebu kontinuiranog liječenja.
English: As with any topical medicinal product, patients should wash their hands after application if the hands are not intended for treatment.
Croatian: Kao i nakon nanošenja bilo kojeg topikalnog lijeka, bolesnici trebaju oprati ruke nakon primjene,
English: Adults and adolescents (16 years of age and above)
Croatian: Odrasli i adolescenti (u dobi od 16 ili više godina)
English: 146 days
Croatian: 146 dana
English: Children • Protopic ointment is not approved for children younger than 2 years of age.
Croatian: • Protopic mast nije odobrena za djecu mlađu od 2 godine.
English: Repeated topical administration of tacrolimus ointment or the ointment vehicle to rats, rabbits and micropigs was associated with slight dermal changes such as erythema, oedema and papules.
Croatian: Ponavljana topikalna primjena takrolimus masti ili podloge masti u štakora, kunića i patuljastih svinja bila je povezana s blagim kožnim promjenama kao što su eritem, edem i papule.
English: Patients were randomised to receive either tacrolimus ointment (0.1% adults; 0.03% children) or vehicle, once a day twice weekly on Mondays and Thursdays.
Croatian: Bolesnici su bili randomizirani u skupinu koja je primala takrolimus mast (0,1% u odraslih; 0,03% u djece) ili podlogu, jedanput na dan dvaput tjedno, ponedjeljkom i četvrtkom.
English: The primary endpoint was the response rate at month 3
Croatian: Primarni ishod bila je stopa odgovora nakon
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 Protopic ointment (see section 5.3).
Croatian: Tijekom primjene Protopic masti potrebno je smanjiti izlaganje kože suncu, a uporaba ultraljubičastog (UV) svjetla u solarijima i terapija UVB ili UVA zrakama u kombinaciji s psoralenima (PUVA) mora se izbjegavati (vidjeti dio 5.3).
English: Protopic ointment should be applied as a thin layer to affected or commonly affected areas of the skin.
Croatian: Protopic mast potrebno je nanijeti u tankom sloju na zahvaćena ili obično zahvaćena područja kože.
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).
Croatian: Rezultati tog multicentričnog, dvostruko slijepog, randomiziranog ispitivanja pokazali su da je takrolimus mast, kako od 0,03% tako i od 0,1%, značajno djelotvornija (p < 0,001 za obje jačine) nego mast sa 1% hidrokortizon acetata (Tablica 2).
English: Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin with minimal diffusion into the systemic circulation.
Croatian: Nakon topikalne primjene takrolimus masti, takrolimus selektivno prodire u kožu i minimalno ulazi u sistemsku cirkulaciju.
English: Protopic is a white to slightly yellowish ointment.
Croatian: Protopic je bijela do blago žućkasta mast.
English: Patients with atopic dermatitis treated with Protopic have not been found to have significant systemic tacrolimus levels.
Croatian: U bolesnika s atopijskim dermatitisom koji se liječe Protopic mašću nisu opažene značajne sistemske razine takrolimusa.
English: Systemically available tacrolimus is metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4).
Croatian: Sistemski dostupan takrolimus metabolizira se putem jetrenog citokroma P450 3A4 (CYP3A4).
English: 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.
Croatian: Primarni ishod u ovom ispitivanju bila je stopa odgovora na cijepljenje, definirana kao stopa bolesnika s titrom baktericidnih protutijela u serumu (SBA) ≥ 8 prilikom posjeta u 5. tjednu.
English: Median mEASI as Percentage of Baseline mean AUC (Primary Endpoint)§
Croatian: Medijan mEASI-ja kao stopa početnog prosječnog AUC-a (primarni ishod)§
English: The review of the child`s condition after 12 months treatment should include suspension of treatment to assess the need to continue this regimen and to evaluate the course of the disease.
Croatian: Pregled stanja bolesnika nakon 12 mjeseci liječenja treba uključivati privremenu obustavu liječenja kako bi se procijenila potreba nastavka takve primjene i da se procijeni tijek bolesti.
English: Due to the nature of the ointment vehicle, induction of vomiting or gastric lavage is not recommended.
Croatian: Zbog prirode masne podloge, ne preporučuje se izazivanje povraćanja ili ispiranje želuca.
English: A seven-month, double blind, randomised parallel group study of paediatric patients (2-11 years) with moderate to severe atopic dermatitis was performed.
Croatian: Provedeno je dvostruko slijepo, randomizirano ispitivanje na usporednim skupinama u trajanju od sedam mjeseci u pedijatrijskih bolesnika (u dobi od 2 do 11 godina) s umjerenim do teškim atopijskim dermatitisom.
English: Local skin infection regardless of specific aetiology including but not limited to:
Croatian: Infekcije i infestacije lokalne infekcije kože bez obzira na konkretan uzrok uključujući, između ostaloga:
English: Hydrocortisone acetate 1% Twice daily (N=207)
Croatian: Hidrokortizon acetat 1% Dvaput na dan (N = 207)
English: During this period all patients and control subjects (n=44) received a primary immunisation and a rechallenge with a protein-conjugate vaccine against Neisseria menigitidis serogroup C.
Croatian: Tijekom ovog razdoblja, u svih je bolesnika i kontrolnih ispitanika (n = 44) provedena primarna imunizacija i ponovna primjena protein konjugiranog cjepiva protiv bakterije
English: How to use Protopic
Croatian: Kako primjenjivati Protopic
English: Systemically available tacrolimus is extensively metabolised in the liver via CYP3A4.
Croatian: Sistemski dostupan takrolimus opsežno se metabolizira u jetri putem CYP3A4.
English: Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap.
Croatian: Laminirana tuba iznutra obložena polietilenom niske gustoće i opremljena bijelim polipropilenskim zatvaračem s navojem.
English: The incidence of local skin burning was higher in the tacrolimus treatment groups than in the hydrocortisone group.
Croatian: Incidencija lokalnog žarenja na koži bila je veća u skupinama liječenima takrolimusom nego u skupini liječenoj hidrokortizonom.
English: What you need to know before you use Protopic Do not use Protopic
Croatian: Što morate znati prije nego počnete primjenjivati Protopic
English: Treatment should not be continuous on a long-term basis.
Croatian: Liječenje se ne smije kontinuirano provoditi bez prekida.
English: • The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321) and all-rac-α-tocopherol.
Croatian: • Drugi sastojci su bijeli vazelin, tekući parafin, propilenkarbonat, bijeli pčelinji vosak, tvrdi parafin, butilhidroksitoluen (E321) i sav-rac-α-tokoferol.
English: Protopic contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Croatian: Protopic sadrži butilhidroksitoluen (E321), koji može uzrokovati lokalne kožne reakcije (npr. kontaktni dermatitis), ili nadražiti oči i sluznice.
English: While using Protopic, drinking alcohol may cause the skin or face to become flushed or red and feel hot.
Croatian: Za vrijeme primjene Protopic masti konzumiranje alkohola može prouzročiti nalete crvenila ili vrućine na koži ili licu.
English: Each affected region of the skin should be treated with Protopic until lesions are cleared, almost cleared or mildly affected.
Croatian: Protopic mašću je potrebno liječiti svako zahvaćeno područje kože sve dok lezije potpuno ili gotovo ne nestanu ili blago ne zahvaćaju kožu.
English: 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.
Croatian: Sistemska izloženost nakon topikalne primjene takrolimus masti je niska (<1,0 ng/ml) i na nju najvjerojatnije neće utjecati istovremena primjena tvari za koje se zna da inhibiraju CYP3A4.
English: 142 days
Croatian: 142 dana
English: Children (2 years of age and older)
Croatian: Djeca (u dobi od 2 godine i starija)
English: Between applications there should be 2-3 days without Protopic treatment.
Croatian: Između primjena treba biti stanka od 2-3 dana bez liječenja Protopic mašću.
English: 17 days
Croatian: 17 dana
English: A statistically significant better improvement was shown for once daily and twice daily 0.03% tacrolimus ointment compared to twice daily hydrocortisone acetate ointment (p<0.001 for both).
Croatian: Pokazalo se da je poboljšanje statistički značajno bolje uz primjenu masti sa 0,03% takrolimusa jedanput na dan i dvaput na dan u usporedbi s mašću s hidrokortizon acetatom dvaput na dan (p < 0,001 za obje primjene).
English: There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the clinical trial.
Croatian: Nije bilo klinički važnih promjena u laboratorijskim vrijednostima ili vitalnim znakovima ni u jednoj terapijskoj skupini tijekom cijelog trajanja kliničkog ispitivanja.
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.
Croatian: Jetreni klirens sistemski dostupnog takrolimusa može biti smanjen u ispitanika s teškim oštećenjem jetre ili u ispitanika koji se istovremeno liječe lijekovima koji su jaki inhibitori CYP3A4.
English: Protopic 0.1 % ointment is indicated in adults and adolescents (16 years of age and above)
Croatian: Protopic 0,1% mast indicirana je u odraslih, adolescenata (u dobi od 16 ili više godina).
English: • facial flushing or skin irritation after drinking alcohol is also common
Croatian: • naleti crvenila u licu ili nadraženost kože nakon konzumiranja alkohola također je česta
English: Following twice-weekly treatment application site infections have been reported in adults.
Croatian: Nakon liječenja primjenom dvaput tjedno zabilježene su infekcije na mjestu primjene u odraslih.
English: 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, one in adult patients (≥16 years) and one in paediatric patients (2-15 years).
Croatian: Djelotvornost i sigurnost takrolimus masti u terapiji održavanja kod blagog do teškog atopijskog dermatitisa bila je procijenjena u 524 bolesnika u fazi III dva multicentrična, klinička ispitivanja sličnog ustroja, jednog u odraslih bolesnika (≥ 16 godina) i jednog u pedijatrijskih bolesnika (2
English: Since commercial availability a very small number of people who have used Protopic ointment have had malignancies (for example lymphoma, including skin lymphoma, and other skin tumours).
Croatian: Nakon stavljanja u promet, vrlo mali broj osoba koje su primjenjivale Protopic mast imao je zloćudnu bolest (na primjer, limfom, uključujući kožni limfom i druge tumore kože).
English: Table 2: Efficacy at week 3
Croatian: Tablica 2: Djelotvornost u 3. tjednu
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
Croatian: Većina bolesnika s atopijskim dermatitisom (odrasli i djeca) liječenih jednokratnom ili ponovljenom primjenom takrolimus masti (0,03-0,1%) i dojenčad u dobi od 5 mjeseci liječena takrolimus mašću
English: The primary endpoint was defined as the percentage decrease in mEASI from the baseline to end of treatment.
Croatian: Primarni ishod bio je definiran kao stopa smanjenja mEASI od početne vrijednosti do vrijednosti na kraju liječenja.
English: Adults and adolescents (16 years of age and above) Treatment should be started with Protopic 0.1% twice a day and treatment should be continued until clearance of the lesion.
Croatian: Odrasli i adolescenti (u dobi od 16 ili više godina) Liječenje je potrebno započeti Protopic 0,1% mašću dvaput na dan i nastaviti sve do nestanka lezija.
English: Pruritus decreased over time in the tacrolimus groups but not in the hydrocortisone group.
Croatian: Svrbež se smanjio tijekom vremena u skupini liječenoj takrolimusom, ali ne i u skupini liječenoj hidrokortizonom.
English: Emollients should not be applied to the same area within 2 hours of applying Protopic ointment.
Croatian: Emolijensi se ne smiju nanositi na isto područje na koje je primijenjena Protopic mast 2 sata nakon nanošenja.
English: Table 3: Efficacy at week 3
Croatian: Tablica 3: Djelotvornost u 3. tjednu
English: 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.
Croatian: U životinja liječenih takrolimus mašću pokazalo se da je vrijeme do pojave kožnih tumora (karcinom skvamoznih stanica) statistički značajno kraće i da je povećan broj tumora.
English: 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.
Croatian: Ako je nastupila egzacerbacija bolesti, bolesnici su bili liječeni u otvorenom ispitivanju takrolimus mašću dvaput na dan tijekom najviše 6 tjedana sve dok se rezultat na ljestvici opće procjene ispitivača nije vratio na ≤ 2.
English: Global Assessment [IGA] ≤ 2, i.e. clear, almost clear or mild disease) for a maximum of 6 weeks.
Croatian: Global Assessment-IGA] ≤ 2, tj, bolest je potpuno nestala, gotovo potpuno nestala ili je blaga) tijekom najviše 6 tjedana.