FrancophonIA/ELRC3.0 huggingface dataset:
English: Information on re-treating actinic keratosis lesions that have cleared after one or two courses of treatment and subsequently recur is given in section 4.2 and 5.1.
Croatian: Informacije o ponovnom liječenju lezija aktiničke keratoze koje su nestale nakon jednoga ili dvaju ciklusa liječenja, a naknadno se opet pojavile, dane su u dijelovima 4.2. i 5.1.
English: If the lesions have not all disappeared, further four weeks of treatment may be necessary.
Croatian: Ako lezije nisu potpuno nestale, možda će biti potrebno liječenje daljnjih 4 tjedna.
English: • If you are being treated for genital warts follow these additional precautions:
Croatian: • Ako liječite genitalne bradavice, pridržavajte se sljedećih dodatnih mjera opreza:
English: There have been postmarketing reports of elevated liver enzymes.
Croatian: Postoje izvještaji iz razdoblja nakon stavljanja lijeka u promet o povišenim enzimima jetre.
English: While limited data have shown an increased rate of wart reduction in HIV positive patients, imiquimod cream has not been shown to be as effective in terms of wart clearance in this patient group.
Croatian: Iako su ograničeni podaci pokazali da imikvimod krema smanjuje broj bradavica kod HIV pozitivnih bolesnika, uočena je manja učinkovitost u njihovom odstranjivanju u ovoj skupini bolesnika.
English: Lower frequencies from clinical trials are not reported here.
Croatian: Niža učestalost zabilježena tijekom kliničkih ispitivanja ovdje nije navedena.
English: Each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods.
Croatian: Pojedino razdoblje liječenja ne smije trajati dulje od 4 tjedna, čak ni u slučaju propuštene doze ili pauze u liječenju.
English: Leave Aldara cream on the warts for 6 to 10 hours.
Croatian: 5. Ostavite da krema Aldara djeluje na bradavice 6 do 10 sati.
English: Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Croatian: Cetilni alkohol i stearilni alkohol mogu uzrokovati lokalne kožne reakcije (npr. kontaktni dermatitis).
English: Benzyl alcohol may cause allergic reactions and mild local irritation.
Croatian: Benzilni alkohol može uzrokovati alergijske reakcije i blagi lokalni nadražaj.
English: A patient with recurrent AK lesions (as defined above) in the completely cleared field had a chance of about 80% to become completely cleared again following an additional imiquimod treatment cycle compared with a chance of about 50% for a re-treatment with topical diclofenac.
Croatian: Bolesnik s ponavljanim lezijama aktiničke keratoze (prema gornjoj definiciji) na potpuno izlječenom području imao je izglede od oko 80% da mu se ponovno potpuno izliječi oboljelo područje nakon dodatnog ciklusa liječenja imikvimodom, u usporedbi s izgledima od oko 50% za ponovljeno liječenje topikalnim diklofenakom.
English: • If you are being treated for basal cell carcinoma or actinic keratosis follow these additional precautions:
Croatian: • Ako liječite bazeocelularni karcinom kože ili aktiničnu keratozu, pridržavajte se sljedećih dodatnih mjera opreza:
English: Wash hands carefully before and after applying the cream.
Croatian: Ruke temeljito operite prije i nakon nanošenja kreme.
English: Persistent dermal overdosing of imiquimod cream could result in severe local skin reactions.
Croatian: Učestalo dermalno predoziranje imikvimod kremom može dovesti do teških lokalnih kožnih reakcija.
English: • Do not use Aldara cream until the area to be treated has healed after previous drug or surgical treatment.
Croatian: • Ne primjenjujte kremu Aldara dok područje koje se liječi ne zacijeli nakon prethodnog liječenja ili kirurškog zahvata.
English: The approved indications genital warts, actinic keratosis and superficial basal cell carcinoma are conditions not generally seen within the paediatric population and were not studied.
Croatian: Odobrene indikacije, genitalne bradavice, aktinična keratoza i površinski bazeocelularni karcinom kože u pravilu se ne uočavaju u pedijatrijskoj populaciji i nisu ispitivani.
English: However, in some cases these reactions have been severe, requiring treatment and/or causing incapacitation.
Croatian: Međutim, u nekim su slučajevima te reakcije bile teške i zahtijevale su liječenje, odnosno prouzročile gubitak funkcije.
English: Some are skin coloured, others are greyish, pink, red or brown.
Croatian: Može biti u boji kože, sivkasta, ružičasta, crvena ili smeđa.
English: After this period it is essential that imiquimod cream is removed with mild soap and water.
Croatian: Nakon tog razdoblja neophodno je imikvimod kremu odstraniti blagim sapunom i vodom.
English: Very common effects include redness (61% patients), wearing away of the skin (30% patients), flakiness and swelling.
Croatian: Vrlo česte nuspojave uključuju crvenilo (61% bolesnika), ljuštenje kože (30%), perutanje i oticanje.
English: Investigators of placebo controlled trials were required to evaluate protocol mandated clinical signs (skin reactions).
Croatian: Od ispitivača koji su proveli placebom kontrolirano ispitivanje tražilo se da ocijene protokolom obvezne kliničke pokazatelje (reakcije na koži).
English: Some systemic adverse reactions, including headache (3.7%), influenza-like symptoms (1.1%), and myalgia (1.5%) were also reported.
Croatian: Prijavljene su i neke sustavne nuspojave uključujući glavobolju (3,7%), simptome nalik gripi (1,1%) i mijalgiju (1,5%).
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 uobičajene, ali njihova jačina se smanjuje tijekom terapije ili se one povlače nakon prekida terapije imikvimod kremom.
English: If you have open sores: do not start using Aldara cream until after the sores have healed.
Croatian: Ako imate otvorene rane, ne započinjite s liječenjem kremom Aldara sve dok rane ne zacijele.
English: Imiquimod cream should be washed from the skin before sexual activity.
Croatian: Imikvimod kremu je potrebno oprati prije spolnog odnosa.
English: Boxes of 12 or 24 single-use polyester/aluminium foil sachets, containing 250 mg of cream.
Croatian: Kutije s 12 ili 24 vrećice od poliesterske/aluminijumske folije za jednokratnu uporabu s 250 mg kreme.
English: Whilst using Aldara cream and until healed, the treatment area is likely to appear noticeably different from normal skin.
Croatian: Tijekom liječenja kremom Aldara i sve do izlječenja područje koje se liječi vjerojatno će izgledati zamjetno drukčije od normalne kože.
English: Urinary recovery was less than 0.6% of the applied dose at week 16 in these patients.
Croatian: Sadržaj u urinu kod ovih bolesnika u 16. tjednu bio je manji od 0,6% primijenjene doze.
English: The efficacy of imiquimod 5 times per week for 6 weeks was studied in two double-blind vehicle controlled clinical trials.
Croatian: Djelotvornost imikvimoda primijenjenog 5 puta tjedno tijekom 6 tjedana ispitivana je u dva dvostruko slijepa podlogom kontrolirana klinička ispitivanja.
English: While serious sequelae have not resulted, the possibility of infection in broken skin should always be considered.
Croatian: Iako ne prouzročava ozbiljne zdravstvene posljedice, potrebno je uzeti u obzir mogućnost pojave infekcije na oštećenoj koži.
English: There are no medicines known to be incompatible with Aldara cream.
Croatian: Nije poznato neslaganje drugih lijekova s kremom Aldara.
English: These protocol mandated clinical sign assessments indicate that local skin reactions including erythema (61%), erosion (30%), excoriation/flaking/scaling (23%) and oedema (14%) were common in these placebo controlled clinical trials with imiquimod cream applied three times weekly (see section 4.4).
Croatian: Procjena obveznih kliničkih pokazatelja pokazala je da su lokalne reakcije na koži, uključujući eritem (61%), erozije (30%), ekskorijaciju/perutanje/ljuskanje (23%) i edem (14%), bile česte u placebo kontroliranom ispitivanju u kojem se imikvimod krema primjenjivala tri puta tjedno (vidjeti dio 4.4).
English: A patient was counted as recurrent in these trials if at least one AK lesion was observed in the completely cleared field whereby a recurrent lesion could be a lesion which occurred at the same location as a formerly cleared lesion or a newly identified lesion anywhere in the treated AK field.
Croatian: U ovim se ispitivanjima smatralo da se bolesniku ponavljaju lezije ako je zabilježena barem jedna lezija aktiničke keratoze na potpuno izliječenom području, pri čemu je ponavljana lezija mogla biti lezija koja se pojavila na istom mjestu kao i prethodno nestala lezija ili novoidentificirana lezija bilo gdje na liječenom području zahvaćenom aktiničkom keratozom.
English: 4-8 AK lesions were treated.
Croatian: Liječeno je 4 do 8 lezija aktinične keratoze.
English: Lesions clinically atypical for AK or suspicious for malignancy should be biopsied to determine appropriate treatment.
Croatian: Kod lezija klinički atipičnih za aktiničnu keratozu ili suspektno malignih potrebno je napraviti biopsiju radi odluke o primjeni odgovarajućeg liječenja.
English: Patients had clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions on the balding scalp or face within a contiguous 25 cm treatment area.
Croatian: Bolesnici su imali klinički tipične, vidljive, diskretne, nehiperkeratotične i nehipertrofične lezije aktinične keratoze na proćelavom tjemenu i licu u području liječenja veličine 25 cm2.
English: The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours.
Croatian: Kremu je potrebno primijeniti prije spavanja i ostaviti da djeluje na koži oko 8 sati.
English: Response of the treated tumour to imiquimod cream should be assessed 12 weeks after the end of treatment.
Croatian: Odgovor liječenog tumora na imikvimod procjenjuje se 12 tjedana nakon završetka liječenja.
English: 56% of the patients have been free of hypopigmentation; hyperpigmentation has not been reported.
Croatian: U 56% bolesnika nije bilo hipopigmentacije.
English: These local skin reactions may be related to the stimulation of local immune response.
Croatian: Te je lokalne kožne reakcije moguće objasniti stimulacijom lokalnoga imunološkog odgovora.
English: ALDARA 5% cream
Croatian: Aldara 5% krema
English: Application to broken skin could result in increased systemic absorption of imiquimod leading to a greater risk of adverse events (refer to section 4.8 and 4.9)
Croatian: Primjena na oštećenu kožu može dovesti do povećane sustavne apsorpcije imikvimoda što povećava rizik od štetnih događaja (vidjeti dio 4.8 i 4.9).
English: Calea Floreasca nr. 169A Floreasca Business Park 014459 București Tel.: +40372 579 000
Croatian: MBGP PRODUCTS SRL Reprezentanța Romania Calea Floreasca nr. 169A Floreasca Business Park 014459 București Tel.: +40372 579 000
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 u liječenju lezija aktinične keratoze s izrazitom hiperkeratozom ili hipertrofijom kao kod npr. kožnih rogova.
English: The application surface area was not controlled in the scalp and hands/ arms groups.
Croatian: Površina primjene nije provjeravana kod skupina kod kojih su liječeni tjeme i šake/ruke.
English: Open a new sachet and squeeze some cream onto your fingertip.
Croatian: 2. Otvorite novu vrećicu i istisnite sadržaj kreme na vrh prsta.
English: In a follow-up of 162 patients five years after treatment for sBCC a mild hypopigmentation was observed in 37% of the patients and a moderate hypopigmentation was observed in 6% of the patients.
Croatian: Praćenjem 162 bolesnika pet godina nakon liječenja manjih površinskih bazeocelularnog karcinoma kože primijećena blaga hipopigmentacija u 37% bolesnika i umjerena hipopigmentacija u 6% bolesnika.
English: Peak serum drug concentrations at the end of week 16 were observed between 9 and 12 hours and were 0.1, 0.2, and 1.6 ng/mL for the applications to face (12.5 mg, 1 single-use sachet), scalp (25 mg, 2 sachets) and hands/arms (75 mg, 6 sachets), respectively.
Croatian: Vršne koncentracije lijeka u serumu zapažene su na kraju 16. tjedna između 9 i 12 sati i iznosile su 0,1 ng/ml kod primjene na lice (12,5 mg, jedna vrećica za jednokratnu primjenu), 0,2 ng/ml kod primjene na tjeme (25 mg, dvije vrećice) i 1,6 ng/ml kod primjene na šake/ruke (75 mg, 6 vrećica).
English: Local skin reactions such as erythema, erosion, excoriation, flaking and oedema are common.
Croatian: Lokalne kožne reakcije kao što su eritem, erozije, ekskorijacija i perutanje kože i edemi su uobičajene.
English: 4.8 Undesirable effects a) General Description:
Croatian: 4.8 Nuspojave a) Opći opis: Vanjske genitalne bradavice:
English: A two-year mouse carcinogenicity study by dermal administration on three days a week did not induce tumours at the application site.
Croatian: U dvogodišnjom ispitivanju kancerogenosti pri dermalnoj primjeni tri puta tjedno provedenom na miševima, nije uočena pojava tumora na mjestu primjene.
English: Imiquimod cream therapy is not recommended until the skin has healed after any previous drug or surgical treatment.
Croatian: Terapija imikvimod kremom ne preporučuje se prije završenog cijeljenja kože nakon prethodnog liječenja ili kirurške intervencije.
English: As no quantifiable levels (> 5 ng/ml) of imiquimod are detected in the serum after single and multiple topical doses, no specific advice can be given on whether to use or not in lactating mothers.
Croatian: Budući da nakon jednokratne ili višekratne topikalne primjene nije zabilježena mjerljiva razina (>5 ng/ml) imikvimoda u serumu, ne može se dati specifičan savjet o uporabi tijekom dojenja.
English: If the treated AK field was not completely cleared of lesions, additional treatment cycles could be started.
Croatian: Ako u liječenom području zahvaćenom aktiničnom keratozom u ispitivanju lezije nisu potpuno nestale, moglo se započeti s dodatnim ciklusima liječenja.
English: If the treated tumour shows an incomplete response, a different therapy should be used (see section 4.4).
Croatian: Ako se utvrdi nepotpuni odgovor tumora, potrebno je primijeniti drugu terapiju (vidjeti dio 4.4).
English: If you forget to use Aldara cream
Croatian: Ako ste zaboravili primijeniti kremu Aldara
English: Actinic keratosis lesions that have cleared after one or two courses of treatment and subsequently recur can be re-treated with one or two further courses of Aldara cream following an at least 12 weeks treatment pause (see section 5.1).
Croatian: Lezije aktiničke keratoze koje su se povukle nakon jednoga ili dvaju ciklusa liječenja, a naknadno se opet pojave, mogu se ponovno liječiti kremom Aldara tijekom jednog ili dva dodatna ciklusa (vidjeti dio 5.1).
English: These adverse events are considered at least possibly causally related to treatment with imiquimod.
Croatian: Za te se štetne događaje smatra da su moguće uzročno povezani s liječenjem imikvimodom.
English: After 6 to 10 hours wash the area where Aldara cream was applied with mild soap and water.
Croatian: Nakon 6 do 10 sati operite područje koje je bilo prekriveno Aldara kremom blagim sapunom i vodom.
English: Metabolism and nutrition disorders: Anorexia
Croatian: Poremećaji metabolizma i prehrane anoreksija često
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Ako se podnošenje periodičkog izvješća o neškodljivosti (PSUR) podudara s nadopunama Plana (RMP), oba dokumenta mogu biti podnesena istodobno.
English: The application frequency and duration of treatment with imiquimod cream is different for each indication.
Croatian: Učestalost primjene i trajanje liječenja imikvimodom u obliku kreme razlikuju se ovisno o indikaciji.
English: The efficacy of imiquimod applied 3 times per week for one or two courses of 4 weeks, separated by a 4 week treatment-free period, was studied in two double-blind vehicle controlled clinical trials.
Croatian: Djelotvornost imikvimoda primijenjenog 3 puta tjedno tijekom jednog ili dva ciklusa liječenja u pojedinačnom trajanju od 4 tjedna, uz 4-tjednu stanku između ciklusa liječenja ispitivana je u dva dvostruko slijepa podlogom kontrolirana klinička ispitivanja.
English: Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with Aldara cream.
Croatian: Tijekom liječenja kremom Aldara nemojte upotrebljavati svjetiljke za sunčanje ili posjećivati solarij i izbjegavajte sunce što je više moguće.
English: Very Commonly the treated skin may be slightly itchy.
Croatian: Vrlo često liječena koža može malo svrbjeti.
English: No clinical experience exists in patients with recurrent and previously treated BCCs, therefore use for previously treated tumours is not recommended.
Croatian: Nema kliničkih iskustava u bolesnika s rekurentnim i prethodno liječenim površinskim bazeocelularnim karcinomom kože, stoga se ne preporučuje uporaba za već liječene tumore.
English: The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 12 weeks after the end of treatment.
Croatian: Klinički ishod terapije može se procijeniti nakon oporavka liječene kože, otprilike 12 tjedana nakon završetka liječenja.
English: Imiquimod has not been evaluated for the treatment of basal cell carcinoma within 1 cm of the eyelids, nose, lips or hairline.
Croatian: Imikvimod nije procjenjivan u liječenju bazeocelularnih karcinoma kože smještenih unutar 1 cm od kapaka, nosa, usana ili linije vlasišta.
English: Saturable binding studies suggest a membrane receptor for imiquimod exists on responding immune cells.
Croatian: Ispitivanja saturabilnog vezanja pokazuju da na reaktivnim imunološkim stanicama postoji membranski receptor za imikvimod.
English: Skin infections during treatment with imiquimod have been observed.
Croatian: Zabilježene su infekcije na koži za vrijeme liječenja imikvimodom.
English: Animals were administered imiquimod cream three times per week and were irradiated 5 days per week for 40 weeks.
Croatian: Imikvimod krema primjenjivana je tri puta tjedno i životinje su zračene pet dana u tjednu tijekom 40 tjedana.
English: Interactions with systemic drugs would be limited by the minimal percutaneous absorption of imiquimod cream.
Croatian: Interakcije s lijekovima za sustavnu primjenu ograničene su minimalnom perkutanom apsorpcijom imikvimod kreme.
English: Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with a possible worsening of their autoimmune condition.
Croatian: Kod tih bolesnika potrebno je procijeniti korist od liječenja imikvimodom u odnosu na rizik od mogućeg pogoršanja autoimune bolesti.
English: Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod cream use.
Croatian: Prijavljena je lokalna hipopigmentacija i hiperpigmentacija nakon primjene imikvimod kreme.
English: In immunocompromised patients, repeat treatment with imiquimod cream is not recommended.
Croatian: U imunokomprimitiranih bolesnika ne preporučuje se ponavljanje liječenja imikvimod kremom.
English: Actinic keratoses are rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime.
Croatian: Aktinična keratoza je promjena na koži hrapavog izgleda koja nastaje u osoba koje su bile tijekom života prekomjerno izložene suncu.
English: Data from an open-label clinical trial suggest that subjects with more than 8 AK lesions showed a decreased rate of complete clearance compared to patients with less than 8 lesions.
Croatian: Podaci iz otvorenog kliničkog ispitivanja pokazuju da je stopa potpunog nestajanja lezija manja kod bolesnika s više od 8 aktiničnih keratoznih lezija u odnosu na bolesnike s manje od 8 lezija.
English: One sachet contains enough cream to cover an area of 25 cm
Croatian: Jedna vrećica sadržava dovoljno kreme za prekrivanje područja od 25 cm2.
English: - If you have any further questions, please ask your doctor or your pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
English: Each containing 250 mg of cream.
Croatian: Svaka sadržava 250 mg kreme.
English: There are very limited data available on the use of imiquimod for the treatment of actinic keratoses in anatomical locations other than the face and scalp.
Croatian: Vrlo je malo podataka o primjeni imikvimoda u liječenju aktinične keratoze na drugim mjestima osim na licu i tjemenu.
English: Hardening under the skin, small open sores, a crust that forms during healing, and small bubbles under the skin may also occur.
Croatian: Također se mogu pojaviti otvrdnuća ispod kože, otvorene male rane, krasta koja nastaje tijekom zacjeljivanja i mjehurići ispod kože.
English: Apart from reactions in the skin, other common effects include swollen glands and back pain.
Croatian: Uz reakcije na koži česte nuspojave uključuju i natečene žlijezde i bol u leđima.
English: Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday, and Friday; or Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for 6 to 10 hours.
Croatian: Imikvimod kremu je potrebno nanositi 3 puta tjedno (primjerice: ponedjeljkom, srijedom i petkom; ili utorkom, četvrtkom i subotom) prije spavanja, a na koži mora ostati tijekom 6 do 10 sati.
English: What Aldara cream contains
Croatian: Što krema Aldara sadrži
English: Superficial basal cell carcinoma (5x/wk, 6 wks) N = 185
Croatian: Površinski bazeocelularni karcinom kože (5 puta tjedno, 6 tjedana) N = 185
English: In trials with 5 times per week dosing 58% of patients experienced at least one adverse event.
Croatian: Tijekom ispitivanja primjene kreme 5 puta tjedno 58% bolesnika prijavilo je najmanje jedan štetan događaj.
English: Methyl hydroxybenzoate (E 218) 2.0 mg/g cream Propyl hydroxybenzoate (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: Pomoćne tvari s poznatim učinkom: 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: In the pivotal trials with 3 times per week dosing for up to 2 courses each of 4 weeks, 56% of imiquimod patients reported at least one adverse event.
Croatian: U ključnim ispitivanjima primjene kreme 3 puta tjedno tijekom najviše 2 ciklusa liječenja u pojedinačnom trajanju od 4 tjedna, 56% bolesnika liječenih imikvimodom prijavilo je najmanje jedan štetni događaj.
English: Thereof 4 of 242 patients (1.7%) of the imiquimod and 7 of 237 patients (3.0%) of the diclofenac group were found to have a histological progression to invasive SCC within the 3-year period.
Croatian: Od toga je kod 4 od 242 bolesnika (1,7%) u skupini liječenoj imikvimodom te kod 7 od 237 bolesnika (3,0%) u skupini liječenoj diklofenakom zabilježena histološka progresija u invazivni karcinom pločastih stanica unutar razdoblja od 3 godine.
English: Local inflammatory reactions may be accompanied, or even preceded, by flu-like systemic signs and symptoms including malaise, pyrexia, nausea, myalgias and rigors.
Croatian: Te lokalne upalne reakcije mogu pratiti ili im čak prethoditi sistemski znakovi i simptomi nalik gripi koji uključuju malaksalost, vrućicu, mučninu, mijalgiju i tresavicu.
English: Should an intolerable skin reaction occur, the cream should be removed by washing the area with mild soap and water.
Croatian: U slučaju pojave nepodnošljive kožne reakcije, kremu je potrebno odstraniti pranjem blagim sapunom i vodom.
English: You might also feel itching (32% patients), a burning sensation (26% patients) or pain in areas where you have applied Aldara cream (8% patients).
Croatian: U području primjene kreme Aldara možete osjetiti svrbež (32% bolesnika), osjećaj žarenja (26% bolesnika) ili bol (8% bolesnika).