FrancophonIA/ELRC3.0 huggingface dataset:
English: However, only 11% (17/160) of patients in clinical trials with Zyclara required rest periods (treatment interruption) due to local adverse reactions.
Croatian: Međutim, za samo 11 % (17/160) bolesnika u kliničkim ispitivanjima sa Zyclarom bilo je potrebno razdoblje odmora (prekid liječenja) zbog lokalnih nuspojava.
English: General instructions during treatment
Croatian: Opće upute tijekom liječenja
English: Biotransformation Orally administered imiquimod is rapidly and extensively metabolised into two main metabolites.
Croatian: Imikvimod primijenjen oralno se brzo i opsežno metabolizira u dva glavna metabolita.
English: Then contact your doctor or pharmacist.
Croatian: Zatim se obratite svom liječniku ili ljekarniku.
English: While using Zyclara, you may experience local skin reactions because of the way it acts on your skin.
Croatian: Dok primjenjujete Zyclaru, možete imati lokalne kožne reakcije zbog načina na koji lijek djeluje na Vašu kožu.
English: The most clinically serious adverse event reported following multiple oral doses of ≥ 200 mg was hypotension which resolved following oral or intravenous fluid administration.
Croatian: Klinički najozbiljniji štetni događaj prijavljen nakon više oralnih doza od ≥ 200 mg bila je hipotenzija, koja je prestala nakon peroralnog ili intravenskog davanja tekućine.
English: In case a dose is missed, patients should wait until the forthcoming night to apply Zyclara and then continue with the regular schedule.
Croatian: U slučaju da se propusti doza, bolesnici moraju pričekati iduću noć da bi primijenili Zyclaru i zatim nastaviti s uobičajenim rasporedom.
English: They can be flat and scaly, or raised, rough, hard and warty.
Croatian: Mogu biti ravna i ljuskava ili izdignuta, gruba, tvrda i bradavičasta.
English: Wash hands well with soap and water.
Croatian: Dobro operite ruke sapunom i vodom.
English: Avoid the concomitant use of Zyclara and any other imiquimod cream in the same treatment area.
Croatian: Izbjegavajte istodobnu primjenu lijeka Zyclara i bilo koje druge imikvimod kreme na istom tretiranom području.
English: Local skin reactions in the treatment area are in part anticipated and common due to its mode of action (see section 4.4).
Croatian: Lokalne kožne reakcije na liječenom području su dijelom očekivane i česte zbog načina djelovanja lijeka (vidjeti dio 4.4).
English: In addition, these studies supported the use of up to two additional treatment cycles of imiquimod when the AK lesions are not completely cleared or if the AK lesions recurred after successful initial treatment with imiquimod.
Croatian: Isto tako, ova su ispitivanja poduprla korištenje do dva dodatna ciklusa liječenja imikvimodom ako AK lezije nisu potpuno nestale ili ako su se AK lezije ponovno pojavile nakon uspješnog prvotnog liječenja imikvimodom.
English: Two open-label randomized, controlled studies investigated the long-term effects of imiquimod 5% (and not with this 3.75% product) in comparison to topical diclofenac (3% gel).
Croatian: Dva otvorena, randomizirana, kontrolirana ispitivanja ispitivala su dugoročni učinak imikvimoda 5% (a ne ovog lijeka od 3,75%) u usporedbi s topikalnim gelom diklofenaka (3%).
English: Local skin reactions can be a sign that the medicine is working as intended.
Croatian: Lokalne kožne reakcije mogu biti znak da lijek djeluje kako je namijenjeno.
English: Imiquimod cream was evaluated in a photocarcinogenicity bioassay in albino hairless mice exposed to simulated solar ultraviolet radiation (UVR).
Croatian: Imikvimod krema ispitivana je u biotestu fotokancerogenosti na albino bezdlakim miševima izloženima simuliranom sunčevom ultraljubičastom zračenju (engl. ultraviolet radiation (UVR)).
English: Patients had 5-20 typical visible or palpable AK lesions in an area that exceeded 25 cm2 on either the face or balding scalp.
Croatian: Bolesnici su imali 5-20 tipičnih vidljivih ili opipljivih AK lezija u području koje prelazi 25 cm2 ili na licu ili na tjemenu bez kose.
English: The treatment starts with a daily application for two weeks, followed by a break without any application for two weeks, and then ends with a daily application again for two weeks.
Croatian: Trajanje liječenja Liječenje počinje svakodnevnom primjenom tijekom dva tjedna nakon čega slijedi period bez nanošenja tijekom dva tjedna, zatim završava ponovnom svakodnevnom primjenom tijekom dva tjedna.
English: The data described below reflect exposure to Zyclara or vehicle in 319 subjects enrolled in two double-blind studies.
Croatian: Dolje opisani podaci odražavaju izloženost Zyclari ili podlozi lijeka u 319 ispitanika uključenih u dva dvostruko slijepa ispitivanja.
English: These studies showed that imiquimod was better than topical diclofenac in preventing the histological progression of AK lesions to in-situ or invasive squamous cell carcinoma (SCC).
Croatian: Ova su ispitivanja pokazala da je imikvimod bolji od topikalnog diklofenaka u sprečavanju histološke progresije AK lezija prema in-situ ili invazivnom karcinomu skvamoznih stanica.
English: Saturable binding studies suggest membrane receptors for imiquimod exists on responding cells; these are called toll-like receptor 7 and 8.
Croatian: Ispitivanja zasićenja vezivanja upućuju na to da membranski receptori za imikvimod postoje na stanicama koje reagiraju na njega, to su toll-like receptori 7 i 8.
English: Cream.
Croatian: Krema.
English: A 18-month mouse carcinogenicity study by dermal administration on three days a week did not induce tumours at the application site.
Croatian: U 18-mjesečnom ispitivanju kancerogenosti na miševima kožna primjena tri dana tjedno nije prouzročila tumore na mjestu primjene.
English: Cream 14 sachets 28 sachets 56 sachets
Croatian: 14 vrećica 28 vrećica 56 vrećica
English: The European Medicines Agency has waived the obligation to submit the results of studies with Zyclara in all subsets of the paediatric population in actinic keratosis (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Zyclara u svim podskupinama pedijatrijske populacije kod aktinične keratoze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Animals were administered imiquimod cream three times per week and were irradiated 5 days per week for 40 weeks.
Croatian: Na životinjama je primijenjena imikvimod krema tri puta tjedno te su bile zračene 5 dana tjedno kroz 40
English: In animal models imiquimod is effective against viral infections and acts as an antitumour agent principally by inducing release of alpha interferon and other cytokines.
Croatian: Na životinjskim modelima imikvimod je učinkovit protiv virusnih infekcija te djeluje kao protutumorsko sredstvo uglavnom potičući otpuštanje interferona alfa i drugih citokina.
English: This medicine has no or negligible influence on the ability to drive and use machines.
Croatian: Ovaj lijek ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i strojevima.
English: In the event of accidental contact, remove cream by rinsing with water.
Croatian: Ako dođe do slučajnog kontakta, odstranite kremu ispiranjem s vodom.
English: If you miss a dose of Zyclara, wait until the next night to apply it and then continue with the regular schedule.
Croatian: Ako propustite dozu Zyclare, pričekajte do iduće noći da je primijenite te nastavite s redovitim rasporedom.
English: Application to broken skin could result in increased systemic absorption of imiquimod leading to a greater risk of adverse events (see section 4.8 and 4.9).
Croatian: Primjena na oštećenu kožu može dovesti do povećane sistemske apsorpcije imikvimoda i većeg rizika za razvoj nuspojava (vidjeti dijelove 4.8 i 4.9)
English: The intensity of the local skin reactions tend to be lower in the second cycle than in the first treatment cycle with Zyclara.
Croatian: Intenzitet lokalnih kožnih reakcija obično je manji u drugom ciklusu nego u prvom ciklusu liječenja lijekom Zyclara.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdrastvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: Persistent topical overdosing of imiquimod cream could result in severe local skin reactions and may increase the risk for systemic reactions.
Croatian: Uporno topikalno predoziranje imikvimod kremom može rezultirati teškim lokalnim kožnim reakcijama te može povećati rizik od sistemskih reakcija.
English: Apply a thin layer of Zyclara to the affected area.
Croatian: Nanesite tanki sloj Zyclare na zahvaćeno područje.
English: Do not use this medicine after the expiry date which is stated on the outer carton and the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i označavanju iza oznake“EXP“.
English: There are no data available of the use of imiquimod in children and adolescents.
Croatian: Nema dostupnih podataka o primjeni imikvimoda u djece i adolescenata.
English: Response to treatment cannot be adequately assessed until resolution of local skin reactions.
Croatian: Odgovor na liječenje se ne može prikladno procijeniti prije prolaska lokalnih kožnih reakcija.
English: Contact with eyes, lips and nostrils should be avoided as imiquimod has not been evaluated for the treatment of actinic keratosis on the eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border.
Croatian: Potrebno je izbjegavati kontakt s očima, usnama i nosnicama jer imikvimod nije ispitivan u liječenju aktinične keratoze kapaka, unutrašnjosti nosnica ili ušiju te područja usana unutar granica ruba usne.
English: When any skin reaction has gone you may then continue with your treatment in the recommended regular schedule.
Croatian: Kada prestanu sve kožne reakcije možete nastaviti s Vašim liječenjem po preporučenom redovitom rasporedu.
English: The prescriber should demonstrate the proper application technique to the patient to maximise the benefit of Zyclara therapy.
Croatian: Liječnik koji propisuje lijek mora pokazati ispravnu tehniku nanošenja bolesniku da bi se postigla najveća moguća korist terapije Zyclarom.
English: Local skin reactions are common but these reactions generally decrease in intensity during therapy or resolve after cessation of imiquimod cream therapy.
Croatian: Lokalne kožne reakcije su česte, ali se intenzitet tih reakcija općenito smanjuje tijekom liječenja ili se one povlače nakon prekida liječenja imikvimod kremom.
English: - experience with imiquimod 5% cream
Croatian: - iskustvo s imikvimod 5% kremom
English: Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod 5 % cream use.
Croatian: Primljene su prijave lokalizirane hipopigmentacije i hiperpigmentacije nakon primjene imikvimod 5% kreme.
English: Furthermore, imiquimod has the potential to exacerbate inflammatory conditions of the skin.
Croatian: Nadalje, imikvimod ima potencijal za egzacerbaciju upalnih stanja kože.
English: Mylan Products Ltd. Station Close Potters Bar Hertfordshire EN6 1TL
Croatian: Station Close Potters Bar Hertfordshire EN6 1TL
English: Interactions with systemic medicinal products would be limited by the minimal percutaneous absorption of imiquimod cream.
Croatian: Interakcije sa sistemskim lijekovima bile bi ograničene minimalnom perkutanom apsorpcijom imikvimod kreme.
English: During therapy and until healed, affected skin is likely to appear noticeably different from normal skin.
Croatian: Tijekom terapije i do izlječenja zahvaćena će koža vjerojatno izgledati primjetno drukčije od normalne kože.
English: Patients should continue treatment as prescribed.
Croatian: Bolesnici moraju nastaviti liječenje kako je propisano.
English: • Do not cover the treated area with bandages or other dressings after you have applied this medicine.
Croatian: • Ne pokrivajte liječeno područje zavojima ili drugim pokrivalima nakon primjene ovog lijeka.
English: The small amount of medicinal product which was absorbed into the systemic circulation was promptly excreted by both urinary and faecal routes at a mean ratio of approximately 3 to 1.
Croatian: Mala količina lijeka koja je apsorbirana u sistemsku cirkulaciju brzo je izlučena putem urina i fecesa pri srednjem omjeru od otprilike 3 naspram 1.
English: Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated either with the possibility of organ rejection or graft-versus-host disease or a possible worsening of their autoimmune condition.
Croatian: Za ove bolesnike treba odvagnuti korist liječenja imikvimodom s rizikom povezanim ili s mogućnošću odbacivanja organa ili bolešću transplantata protiv primatelja, ili s mogućim pogoršanjem njihova autoimuna stanja.
English: Lesions that do not respond completely to treatment at 8 weeks after the second treatment cycle should be carefully re-evaluated and one additional 2-week treatment of Zyclara may be considered.
Croatian: Lezije koje nisu u potpunosti reagirale na liječenje u 8. tjednu nakon drugog ciklusa liječenja potrebno je pažljivo ponovno procijeniti i potrebno je razmotriti dodatno dvotjedno liječenje lijekom Zyclara.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europe.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Therefore, imiquimod cream should be used with caution in these patients (see section 4.5).
Croatian: Stoga je imikvimod kremu potrebno primjenjivati s oprezom u ovih bolesnika (vidjeti dio 4.5).
English: 170 09 Solna Sweden
Croatian: 170 09 Solna Švedska
English: This medicine should not be applied to areas larger than either the full face or balding scalp.
Croatian: Ovaj lijek se ne smije nanositi na područja veća od ili cijelog lica ili tjemena bez kose.
English: Zyclara has no or negligible influence on the ability to drive and use machines.
Croatian: Zyclara ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Loughborough Leicestershire LE11 5SF, United Kingdom
Croatian: Loughborough Leicestershire LE11 5SF
English: A transient increase in actinic keratosis counts may be observed during treatment due to the likely effect of imiquimod to reveal and treat subclinical lesions.
Croatian: Tijekom liječenja se može opaziti prolazno povećanje broja aktiničnih keratoza zbog vjerojatnog učinka imikvimoda da otkrije i liječi supkliničke lezije.
English: This medicine may also cause flu-like symptoms (including tiredness, nausea, fever, muscle and joint pain, and shivering) before or during the occurrence of local skin reactions.
Croatian: Ovaj lijek može također prouzročiti simptome slične gripi (uključujući umor, mučninu, vrućicu, mišićnu bol i bol u zglobovima te drhtanje) prije ili tijekom pojave lokalnih kožnih reakcija.
English: Concomitant use of Zyclara and any other imiquimod creams in the same treatment area should be avoided since they contain the same active ingredient (imiquimod) and may increase the risk for and severity of local skin reactions.
Croatian: Mora se izbjegavati istodobna primjena Zyclare i drugih imikvimod krema na istom području koje se liječi jer sadrže istu djelatnu tvar (imikvimod) te mogu povećati rizik i težinu lokalnih kožnih reakcija.
English: There is an association between the complete clearance rate and the intensity of local skin reactions (e.g. erythema).
Croatian: Postoji povezanost između stope potpunog nestanka lezija i intenziteta lokalnih kožnih reakcija (npr.
English: General instructions for treatment
Croatian: Opće upute za liječenje
English: Before applying the cream, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly.
Croatian: Prije nanošenja kreme bolesnik mora oprati područje koje se liječi blagim sapunom i vodom te pustiti da se područje potpuno osuši.
English: A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction.
Croatian: Može se uzeti razdoblje odmora od nekoliko dana ako je to potrebno zbog bolesnikove nelagode ili težine lokalne kožne reakcije.
English: Once the discomfort stops you can resume your treatment schedule as recommended.
Croatian: Kada nelagoda prestane, možete nastaviti s rasporedom liječenja kako je preporučeno.
English: Local dermal irritation, especially at higher doses, was observed in both species.
Croatian: U obje je vrste opažena lokalna iritacija kože, osobito pri višim dozama.
English: Before going to bed, wash your hands and the treatment area carefully with mild soap and water.
Croatian: Prije odlaska u krevet, pažljivo operite ruke i područje koje se liječi blagim sapunom i vodom.
English: Management of overdose should consist of treatment of clinical symptoms.
Croatian: U slučaju predoziranja nužno je liječiti kliničke simptome.
English: Mylan Hrvatska d.o.o.
Croatian: Mylan Hrvatska d.o.o. Koranska 2
English: Each treatment cycle should last no longer than two weeks, even if you have missed doses.
Croatian: Nijedan ciklus liječenja ne smije trajati dulje od dva tjedna, čak i ako ste propustili dozu.
English: Date of first authorisation: 23/08/2012 Date of latest renewal: 22/03/2017
Croatian: Datum posljednje obnove odobrenja: 22. ožujka 2017.
English: The treatment area is the full face or balding scalp.
Croatian: Područje koje se liječi je cijelo lice ili tjeme bez kose.
English: If required by the patient's discomfort or the intensity of the local skin reaction, a rest period of several days may be taken.
Croatian: Ako je to potrebno zbog bolesnikove nelagode ili intenziteta lokalne kožne reakcije, može se uzeti razdoblje odmora od nekoliko dana.
English: Imiquimod is not recommended for the treatment of AK lesions with marked hyperkeratosis or hypertrophy as seen in cutaneous horns.
Croatian: Imikvimod se ne preporučuje za liječenje AK lezija s izraženom hiperkeratozom ili hipertrofijom kao kod kožnih rogova.
English: What you need to know before you use Zyclara 3.
Croatian: Što morate znati prije nego počnete primjenjivati Zyclaru
English: Each gram of cream contains 37.5 mg of imiquimod.
Croatian: Svaki gram kreme sadrži 37,5 mg imikvimoda.
English: Patients with reduced haematologic reserve have not been studied in clinical trials.
Croatian: Bolesnici sa smanjenom hematološkom rezervom nisu bili ispitivani u kliničkim ispitivanjima.
English: It is not known whether imiquimod passes into breast milk.
Croatian: Nije poznato prolazi li imikvimod u majčino mlijeko.
English: Topical in vivo application of imiquimod cream on mouse skin resulted in increased concentrations of IFN and tumour necrosis factor (TNF) compared with skin of untreated mice.
Croatian: Topikalna in vivo primjena imikvimod kreme na mišjoj koži rezultirala je povećanim kocentracijama IFN-a i faktora nekroze tumora (TNF) u usporedbi s kožom netretiranih miševa.
English: Clinical studies investigating the use of imiquimod 5% cream for the treatment of actinic keratosis have detected a 0.4% (5/1214) frequency of alopecia at the treatment site or surrounding area.
Croatian: Klinička ispitivanja koja su istraživala primjenu imikvimod 5% kreme u liječenju aktinične keratoze otkrila su učestalost od 0,4 % (5/1214) alopecije na liječenom ili okolnom području.
English: The apparent half-life following topical dosing of 3.75% imiquimod cream in the pharmacokinetic study was calculated as approximately 29 hours.
Croatian: Izračunati prividni poluvijek nakon topikalnog doziranja imikvimod 3,75% kreme u farmakokinetičkom ispitivanju bio je približno 29 sati.
English: Zyclara should be applied as a thin film to the entire treatment area and rubbed in until the cream vanishes.
Croatian: Zyclaru je potrebno primijeniti u tankom sloju na cijelo područje koje se liječi i utrljavati dok krema ne nestane.
English: EU/1/12/783/001 14 sachets EU/1/12/783/002 28 sachets EU/1/12/783/003 56 sachets
Croatian: EU/1/12/783/002 28 vrećica EU/1/12/783/003 56 vrećica
English: Treatment should be continued for the full treatment course even if all actinic keratosis appear to be gone.
Croatian: Liječenje je potrebno nastaviti u svom punom trajanju, čak i ako se čini da su sve aktinične keratoze nestale.
English: Increases in systemic levels of alpha interferon and other cytokines following topical application of imiquimod were also observed in human data.
Croatian: Povećanje u sustavnim razinama interferona alfa i drugih citokina nakon topikalne primjene imikvimoda bilo je također opaženo i u podacima dobivenim od ljudskih ispitanika.
English: Lesions clinically atypical for AK or suspicious for malignancy should be biopsied to determine appropriate treatment.
Croatian: Kod lezija klinički nekarakterističnih za AK ili suspektno malignih lezija mora se napraviti biopsija kako bi se odredilo odgovarajuće liječenje.
English: Methyl parahydroxybenzoate (E 218) 2.0 mg/g cream Propyl parahydroxybenzoate (E 216) 0.2 mg/g cream Cetyl alcohol 22.0 mg/g cream Stearyl alcohol 31.0 mg/g cream Benzyl alcohol 20.0 mg/g cream
Croatian: metilparahidroksibenzoat (E 218) 2,0 mg/g kreme propilparahidroksibenzoat (E 216) 0,2 mg/g kreme cetilni alkohol 22,0 mg/g kreme stearilni alkohol 31,0 mg/g kreme benzilni alkohol 20,0 mg/g kreme
English: Zyclara should be applied once daily before bedtime to the skin of the affected treatment field (area) and remain on the skin for approximately 8 hours.
Croatian: Zyclaru je potrebno primijeniti jedanput dnevno prije spavanja na kožu zahvaćenog područja koje se liječi te ostaviti da djeluje na koži približno 8 sati.
English: If you have applied too much cream, wash the extra away with mild soap and water.
Croatian: Ako ste nanijeli previše kreme, isperite višak blagim sapunom i vodom.
English: If you experience these, stop using this medicine and tell your doctor immediately.
Croatian: Ako Vam se ovo dogodi, prekinite primjenjivati ovaj lijek i odmah se obratite svom liječniku.
English: Sachets should not be re-used once opened.
Croatian: Jednom otvorene vrećice ne smiju se ponovno upotrijebiti.
English: 1138 Budapest Váci út 150
Croatian: 1138 Budapest
English: The panel of induced cytokines varies with the cell's tissue origin.
Croatian: Skupina induciranih citokina varira ovisno o podrijetlu staničnog tkiva.
English: In clinical trials most patients (159/160) using Zyclara for the treatment of AK experience local skin reactions (most frequently erythema, scab, and exfoliation/application site dryness) at the application site.
Croatian: U kliničkim ispitivanjima većina bolesnika (159/160) koji su primjenjivali Zyclaru u liječenju AK iskusila je lokalne kožne reakcije (najčešće eritem, kraste i ljuštenje/suhoću) na mjestu primjene.
English: Flu-like systemic signs and symptoms may accompany, or even precede, intense local skin reactions and may include fatigue, nausea, fever, myalgias, arthralgias, and chills.
Croatian: Sistemski znakovi i simptomi nalik gripi mogu pratiti ili čak prethoditi intenzivnim lokalnim kožnim reakcijama i mogu uključivati umor, mučninu, vrućicu, mialgije, atralgije i zimicu.
English: It is unknown whether imiquimod/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se imikvimod/metaboliti u majčino mlijeko.
English: Serious skin reactions (frequency not known) with skin lesions or spots on your skin that start out as small red areas and progress to look like mini targets, possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores.
Croatian: Ozbiljne kožne reakcije (učestalost nije poznata) s kožnim lezijama ili točkama na koži koje počnu kao mala crvena područja te se razvijaju do izgleda poput male mete, moguće sa simptomima kao što su svrbež, vrućica, opći osjećaj bolesti, bolni zglobovi, problemi s vidom, pečenje, bolne oči ili svrbež očiju i ranice u ustima.