FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe erythema (24%) and severe scabbing and crusting (20%) were very common.
Croatian: Teški eritem (24%) i teško stvaranje krasti (20%) bilo je vrlo često.
English: • If you have previously used Aldara cream or other similar preparations tell your doctor before starting this treatment.
Croatian: • Ako ste već primjenjivali kremu Aldara ili drugi sličan lijek, obvezno o tome obavijestite svojeg liječnika prije početka liječenja.
English: In a pooled analysis of these two studies, histological clearance was noted in 82% (152/185) of patients.
Croatian: U združenoj analizi tih dvaju ispitivanja histološki nestanak primijećeno je u 82% (152/185) bolesnika.
English: d) Adverse events applicable to all indications:
Croatian: d) Štetni događaji primjenjivi na sve indikacije:
English: Aldara should not be used in children with molluscum contagiosum due to lack of efficacy in this indication (see section 5.1).
Croatian: Aldara se ne smije primjenjivati u djece s molluscum contagiosum zbog nedjelotvornosti kod te indikacije (vidjeti dio 5.1).
English: Frequencies are defined as Very common (1/10), Common (1/100 to <1/10) and Uncommon (1/1,000 to <1/100).
Croatian: Učestalost nuspojava definirana je na sljedeći način: vrlo često ( 1/10), često ( 1/100 do < 1/10) i manje često ( 1/1000 do < 1/100).
English: 250 mg cream
Croatian: 250 mg kreme
English: 24 sachets.
Croatian: 24 vrećica.
English: There is clinical experience from 90 patients who got 3 or more imiquimod treatment cycles, 80 patients received 5 or more courses of imiquimod treatment over the 3-year study period.
Croatian: Postoji kliničko iskustvo za 90 bolesnika koji su primili 3 ili više ciklusa liječenja imikvimodom, a 80 bolesnika primilo je 5 ili više ciklusa liječenja imikvimodom tijekom trogodišnjeg razdoblja ispitivanja.
English: Patients with reduced haematologic reserve have not been studied in clinical trials.
Croatian: Bolesnici sa smanjenom hematološkom rezervom nisu ispitivani u kliničkim ispitivanja.
English: Other medicines and Aldara cream
Croatian: Drugi lijekovi i Aldara krema
English: These trials failed to demonstrate efficacy of imiquimod at any of the tested dosage regimens (3x/week for ≤16 weeks and 7x/week for ≤8 weeks).
Croatian: Ta ispitivanja nisu pokazala djelotvornost imikvimoda niti sa jednim ispitivanim režimom doziranja (3 x tjedno tijekom ≤ 16 tjedana i 7 x tjedno tijekom ≤ 8 tjedana).
English: Mylan Healthcare Sp. z o.o.
Croatian: Mylan Healthcare Sp. z o.o. ul.
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 vožnje ili rada sa strojevima.
English: Imiquimod cream treatment should continue until the clearance of visible genital or perianal warts or for a maximum of 16 weeks per episode of warts.
Croatian: Liječenje imikvimod kremom je potrebno nastaviti do nestanka vidljivih genitalnih i perianalnih bradavica ili najdulje tijekom 16 tjedana za svako pojavljivanje bradavica.
English: The mechanism for this is not known, but as imiquimod has low systemic absorption from human skin, and is not mutagenic, any risk to humans from systemic exposure is likely to be low.
Croatian: Mehanizam ove pojave nije poznat, ali kako imikvimod ima nisku sustavnu apsorpciju putem kože i nije mutagen, rizik od sustavne izloženosti u ljudi vjerojatno je malen.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Obratite se svojem liječniku ili ljekarniku za savjet prije nego uzmete bilo koji drugi lijek.
English: If these symptoms occur, stop the treatment immediately and call your doctor.
Croatian: Ako se ti simptomi pojave, odmah prekinite s liječenjem i obratite se svojem liječniku.
English: He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).
Croatian: Liječnik Vam može savjetovati da prestanete primjenjivati kremu Aldara na nekoliko dana (tj. kratku stanku u liječenju).
English: Apply Aldara cream 3 times per week.
Croatian: Primjenjujte kremu Aldara 3 puta tjedno.
English: Meda Health Sales Ireland Ltd. Unit 34/35, Block A Dunboyne Business Park Dunboyne
Croatian: Unit 34/35, Block A Dunboyne Business Park Dunboyne
English: The safety database in uncircumcised men treated with imiquimod cream three times weekly and carrying out a daily foreskin hygiene routine is less than 100 patients.
Croatian: Baza podataka o sigurnosti primjene u neobrezanih muškaraca koji se liječe imikvimod kremom tri puta tjedno uz svakodnevnu higijenu prepucija uključuje manje od 100 bolesnika.
English: Information applicable to all indications:
Croatian: Podaci koji se odnose na sve indikacije:
English: Use in the paediatric patient population is not recommended.
Croatian: Ne preporučuje se uporaba u pedijatrijskoj populaciji.
English: Aldara Cream has been evaluated in four randomised, vehicle controlled, double-blind trials in children aged 2 to 15 years with molluscum contagiosum (imiquimod n = 576, vehicle n = 313).
Croatian: Aldara krema ispitivana je u 4 randomizirana, podlogom kontrolirana, dvostruko slijepa ispitivanja u djece u dobi od 2 do 15 godina s molluscum contagiosum (imikvimod n = 576, podloga n = 313).
English: When any skin reaction has gone you may then continue with your treatment.
Croatian: Kad nestanu reakcije na koži, možete nastaviti s liječenjem.
English: An interruption of dosing should be considered.
Croatian: U tom je slučaju potrebno razmotriti prekidanje terapije.
English: A total of 482 patients were included into the trials, of these 481 patients received study treatments, and of these 243 patients were treated with imiquimod and 238 patients with topical diclofenac.
Croatian: Ukupno je 482 bolesnika bilo uključeno u ispitivanja, od kojih je 481 primilo ispitivano liječenje, a od toga je 243 bolesnika liječeno imikvimodom, a 238 topikalnim diklofenakom.
English: If you miss a dose, apply cream as soon as you remember and then continue in your regular schedule.
Croatian: Ako ste zaboravili primijeniti kremu, nanesite ju čim se sjetite i nastavite dalje prema uobičajenom rasporedu.
English: In younger patients aged 2-5 years absorption, based on Cmax values, was higher compared to adults.
Croatian: U mlađih bolesnika u dobi od 2 do 5 godina apsorpcija procjenjivana putem Cmax vrijednosti, bila je veća nego u odraslih bolesnika.
English: Imiquimod was investigated in controlled clinical studies with paediatric patients (see sections 4.2 and 5.1).
Croatian: Imikvimod je ispitivan u kontroliranim kliničkim ispitivanjima s pedijatrijskim bolesnicima (vidjeti dijelove 4.2 i 5.1).
English: Magyarország Mylan EPD Kft. 1138 Budapest Váci út 150
Croatian: Magyarország Mylan EPD Kft. 1138 Budapest
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu
English: Do not use Aldara cream for more than 16 weeks in the treatment of each episode of warts.
Croatian: Kremu Aldara nemojte primjenjivati dulje od 16 tjedana za liječenje svakog pojavljivanja bradavica.
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 ne smijete upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza EXP.
English: • Warts (condylomata acuminata) on the surface of the genitals (sexual organs) and around the anus (back passage)
Croatian: • bradavica (condylomata acuminata) na površini spolnih organa i u području anusa (izlaza debelog crijeva)
English: If the treated area does not show complete clearance at a follow-up examination about 8 weeks after the last 4-weeks course of treatment, an additional 4-weeks course of Aldara treatment may be considered.
Croatian: Ako liječeno područje ne bude potpuno čisto na kontrolnom pregledu oko 8 tjedana nakon posljednjeg četverotjednog ciklusa liječenja, može se razmotriti dodatni ciklus od 4 tjedna liječenja Aldarom.
English: Your doctor may prescribe Aldara cream for the treatment of:
Croatian: Liječnik Vam može propisati kremu Aldara za liječenje:
English: EU/1/98/080/001 12 sachets EU/1/98/080/002 24 sachets
Croatian: EU/1/98/080/001 12 vrećica EU/1/98/080/002 24 vrećice
English: The extent of percutaneous absorption did not change significantly between the first and last doses of this study.
Croatian: Perkutana apsorpcija nije se značajno mijenjala od prve do posljednje doze u provedenome ispitivanju.
English: Systemic exposure (percutaneous penetration) was calculated from recovery of carbon-14 from 14C imiquimod in urine and faeces.
Croatian: Sustavna izloženost (perkutana penetracija) izračunata je određivanjem povrata ugljika-14 u urinu i stolici iz 14Coznačenog imikvomoda.
English: If you accidentally swallow Aldara cream please contact your doctor.
Croatian: Ako slučajno progutate kremu Aldara, molimo posavjetujte se s liječnikom.
English: In animal models imiquimod is effective against viral infections and acts as an antitumour agent principally by induction of alpha interferon and other cytokines.
Croatian: Kod životinjskih modela imikvimod je učinkovit protiv virusnih infekcija i djeluje kao protutumorski lijek uglavnom indukcijom alfa-interferona i drugih citokina.
English: One-year data from two combined observational studies indicate a recurrence rate of 27% (35/128 patients) in those patients who became clinically clear after one or two courses of treatment.
Croatian: Jednogodišnji podaci iz dvaju kombiniranih opservacijskih ispitivanja ukazuju na stopu povrata bolesti od 27% (35/128 bolesnika) u onih bolesnika koji su klinički izliječeni nakon jednog ili dva ciklusa liječenja.
English: Hands should be washed carefully before and after application of cream.
Croatian: Ruke je potrebno temeljito oprati prije i nakon nanošenja kreme.
English: Do not save the opened sachet for use at a later date.
Croatian: Nemojte čuvati jednom otvorenu vrećicu za buduću uporabu.
English: The treatment frequency and duration differ for genital warts, basal cell carcinoma and actinic keratosis (see specific instructions for each indication).
Croatian: Učestalost i trajanje liječenja razlikuje se kod genitalnih bradavica, bazeocelularnog karcinoma kože i aktinične keratoze (detaljno pročitajte pojedinačne upute za svaku indikaciju).
English: Aldara cream has no or negligible influence on the ability to drive and use machines.
Croatian: Aldara krema ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In other studies, in which a daily foreskin hygiene routine was not followed, there were two cases of severe phimosis and one case of stricture leading to circumcision.
Croatian: U drugim ispitivanjima u kojima bolesnici nisu provodili svakodnevnu higijenu prepucija zabilježena su dva slučaja teške fimoze i jedan slučaj strikture koji je zahtijevao obrezivanje.
English: Based on current knowledge, treating urethral, intra-vaginal, cervical, rectal or intra-anal warts is not recommended.
Croatian: Temeljem dosadašnjih spoznaja, liječenje uretralnih, intravaginalnih, cervikalnih, rektalnih ili intraanalnih bradavica se ne preporučuje.
English: Mylan Medical SAS 40-44 rue Washington
Croatian: Mylan Medical SAS 40-44 rue Washington 75008 Paris
English: What Aldara cream is and what it is used for
Croatian: Što je Aldara krema i za što se primjenjuje
English: Wear protective clothing and wide brimmed hats when outdoors.
Croatian: Kad ste vani, nosite zaštitnu odjeću i šešire sa širokim obodom.
English: Corresponding recurrence rates for vehicle were 47% (8/17 patients) and 7.5% (6/80 lesions).
Croatian: Stopa povrata za podlogu bila je 47% (8/17 bolesnika) i 7,5 % (6/80 lezija).
English: • Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.
Croatian: • klinički tipičnih, nehiperkeratotičnih, nehipertrofičnih aktiničnih keratoza na licu ili tjemenu u odraslih imunokompetentnih bolesnika kada veličina ili broj lezija ograničuje djelotvornost i/ili primjenjivost krioterapije, a druge topikalne metode liječenja su kontraindicirane ili manje pogodne.
English: Continue to use Aldara cream as instructed until your warts have completely gone (half the females who clear will do so in 8 weeks, half the males who clear will do so in 12 weeks but in some patients warts may clear as early as 4 weeks).
Croatian: Nastavite s uporabom kreme Aldara prema uputama sve dok bradavice ne nestanu (kod polovice žena bradavice će potpuno nestati za 8 tjedana, a kod polovice muškaraca bradavice će potpuno nestati za 12 tjedana, dok kod nekih bolesnika bradavice mogu nestati već nakon četvrtog tjedna).
English: For example, apply the cream on Monday, Wednesday and Friday.
Croatian: Kremu primijenite na primjer u ponedjeljak, srijedu i petak.
English: The available data on actinic keratosis on the forearms and hands do not support efficacy in this indication and therefore such use is not recommended.
Croatian: Dostupni podaci o aktiničnoj keratozi na podlakticama i rukama ne govore u prilog djelotvornosti liječenja u toj indikaciji i stoga se ta primjena ne preporučuje.
English: Studies in rabbits reveal a dermal lethal dose of greater than 5 g/kg.
Croatian: Ispitivanja provedena na kunićima pokazala su da je dermalna smrtna doza veća od 5g/kg.
English: • Avoid contact with the eyes, lips and nostrils.
Croatian: • Izbjegavajte kontakt kreme s očima, ustima i nosnicama.
English: However, in rare cases severe local reactions that have required treatment and/or caused temporary incapacitation have been observed in patients who have used imiquimod according to the instructions.
Croatian: Međutim, u rijetkim slučajevima zapažene su teške lokalne reakcije koje su zahtijevale liječenje, i/ili prouzročile privremene poremećaje funkcije u bolesnika koji su se pridržavali uputa o primjeni imikvimoda.
English: (3x/wk, 4 or 8 wks) N = 252
Croatian: (3 puta tjedno, 4 ili 8 tjedana) N = 252
English: Aldara cream helps your body´s own immune system to produce natural substances which help fight your basal cell carcinoma, actinic keratosis or the virus that has caused your warts.
Croatian: Krema Aldara pomaže Vašem imunološkom sustavu u stvaranju prirodnih tvari koje se bore protiv bazeocelularnog karcinoma kože, aktinične keratoze ili virusa koji uzrokuje nastanak bradavica.
English: A lowering of blood counts might make you more susceptible to infections, make you bruise more easily or cause fatigue.
Croatian: Smanjenje broja stanica u krvi može Vas učiniti sklonijima infekcijama, nastajanju modrica ili umornima.
English: Reductions in haematological parameters requiring clinical intervention have been reported from postmarketing experience.
Croatian: O smanjenju hematoloških parametara koje je zahtijevalo kliničku intervenciju izviješteno je nakon stavljanja lijeka u promet.
English: In a four-month rat dermal toxicity study, significantly decreased body weight and increased spleen weight were observed at 0.5 and 2.5 mg/kg; similar effects were not seen in a four month mouse dermal study.
Croatian: U četveromjesečnom ispitivanju dermalne toksičnosti na štakorima pri dozi od 0,5 i 2,5 mg/kg uočeno je znatno smanjenje tjelesne težine i povećanje slezene; slični učinci nisu uočeni u četveromjesečnom ispitivanju na miševima.
English: Apply sufficient Aldara cream to cover the treatment area and 1 cm (about ½ an inch) around the treatment area each day for 5 consecutive days each week for 6 weeks.
Croatian: Nanesite dovoljno kreme da prekrijete liječeno područje i 1 cm oko liječenoga područja svaki dan, 5 uzastopnih dana svaki tjedan tijekom 6 tjedana.
English: If you have the impression that the effect of Aldara cream is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako Vam se čini da je djelovanje kreme Aldara prejako ili preslabo, posavjetujte se sa svojim liječnikom ili ljekarnikom.
English: Imiquimod cream is indicated for the topical treatment of:
Croatian: Imikvimod krema indicirana je za topikalno liječenje:
English: Five -year data from a long-term open-label uncontrolled study indicate that an estimated 77.9% [95% CI (71.9%, 83.8%)] of all the subjects who initially received treatment became clinically clear and remained clear at 60 months.
Croatian: Petogodišnji podaci iz dugotrajnog otvorenog nekontroliranog ispitivanja pokazali su da je otprilike 77,9% [95% CI (71,9%, 83,8%)] svih ispitanika koji su inicijalno liječeni postalo klinički izliječenima i bez povrata bolesti tijekom 60 mjeseci.
English: If you think this applies to you talk to your doctor.
Croatian: Ako mislite da se ova napomena odnosi na Vas, porazgovarajte o tome sa svojim liječnikom.
English: An interruption of dosing should be considered if intense local inflammatory reactions occur (see section 4.4) or if infection is observed at the treatment site.
Croatian: Liječenje je potrebno prekinuti ako dođe do izraženih lokalnih upalnih reakcija (vidjeti dio 4.4) ili se pojavi infekcija na području liječenja.
English: Aldara should only be used for flat actinic keratoses on the face and scalp in patients with a healthy immune system where your doctor has decided that Aldara is the most appropriate treatment for you.
Croatian: Krema Aldara primjenjuje se samo za liječenje ravne aktinične keratoze na licu i tjemenu u bolesnika sa zdravim imunološkim sustavom ako Vaš liječnik odluči da je liječenje kremom Aldara najpogodniji način liječenje za vas.
English: - Each box contains 12 or 24 single-use polyester/aluminium foil sachets.
Croatian: - Svaka kutija sadržava 12 ili 24 vrećice od poliesterske/aluminijske folije za jednokratnu uporabu.
English: The pharmacokinetic properties of imiquimod following single and multiple topical application in paediatric patients with molluscum contagiosum (MC) have been investigated.
Croatian: Istraživana su farmakokinetička svojstva nakon jednokratne ili višekratne topikalne primjene u pedijatrijskih bolesnika s molluscum contagiosum (MC).
English: An apparent half-life was calculated that was approximately 10 times greater than the 2 hour half-life seen following subcutaneous dosing in a previous study, suggesting prolonged retention of drug in the skin.
Croatian: Izračunati prividni poluvijek bio je približno 10 puta veći nego dvosatni poluvijek utvrđen nakon supkutane primjene u prethodnom ispitivanju upućujući na produljeno zadržavanje lijeka u koži.
English: After application of the cream, throw away the opened sachet and wash hands with soap and water.
Croatian: Nakon nanošenja kreme bacite otvorenu vrećicu i operite ruke sapunom i vodom.
English: United Kingdom Mylan Products Ltd. Station Close Potters Bar Hertfordshire EN6 1TL
Croatian: Station Close Potters Bar Hertfordshire EN6 1TL
English: The small amount of drug 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 se apsorbirala u sistemsku cirkulaciju odmah je izlučena urinom i stolicom pri srednjem omjeru od oko 3 prema 1.
English: Vaisalantie 4/Vaisalavägen 4 02130 Espoo/Esbo Puh/Tel: +358 20 720 9550
Croatian: Vaisalantie 4/Vaisalavägen 4 F02130 Espoo/Esbo Puh/Tel: +358 20 720 9550
English: Actinic keratosis in adults
Croatian: Aktinične keratoze u odraslih bolesnika
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: Najozbiljniji klinički štetni događaj zabilježen nakon višekratnih oralnih doza od  200 mg bila je hipotenzija koja je otklonjena peroralnim ili intravenskim davanjem tekućine.
English: Application of an excess of cream or prolonged contact with the skin may result in a severe application site reaction (see sections 4.4, 4.8 and 4.9).
Croatian: Preobilno nanošenje kreme ili dugotrajan dodir s kožom može dovesti do teških reakcija na mjestu primjene (vidjeti dijelove 4.4, 4.8 i 4.9).
English: There was a significant association between the intensity of local skin reactions (e.g. erythema) seen during the treatment period and complete clearance of the basal cell carcinoma.
Croatian: Uočena je značajna povezanost jačine lokalnih reakcija na koži (npr. eritem) koje su se pojavile tijekom razdoblja liječenja i potpunog nastanka bazeocelularnog karcinoma.
English: There was no evidence for systemic reactions.
Croatian: Nije bilo utvrđenih sustavnih reakcija.
English: Caution should be exercised when prescribing to pregnant women.
Croatian: Pri propisivanju lijeka trudnicama potreban je oprez.
English: Local dermal irritation, especially at higher doses, was observed in both species.
Croatian: U obje vrste uočena je lokalna iritacija kože, osobito pri većim dozama.
English: The systemic exposure data demonstrated that the extent of absorption of imiquimod following topical application to the MC lesional skin of the paediatric patients aged 6-12 years was low and comparable to that observed in healthy adults and adults with actinic keratosis or superficial basal cell carcinoma.
Croatian: Podaci o sustavnoj izloženosti pokazuju da je opseg apsorpcije imikvimoda nakon topikalne primjene u području lezije MC u pedijatrijskih bolesnika u dobi od 6 do 12 godina bio nizak i usporediv s apsorpcijom u zdravih odraslih i odraslih s aktiničnom keratozom ili površinskim bazeocelularnim karcinomom kože.
English: Imiquimod is an immune response modifier.
Croatian: Imikvimod je modulator imunološkog odgovora.
English: The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 4-8 weeks after the end of treatment.
Croatian: Klinički ishod terapije može se procijeniti nakon oporavka liječene kože, otprilike 4 - 8 tjedana nakon završetka liječenja.
English: If your skin reacts badly when using Aldara cream, stop applying the cream, wash the area with mild soap and water and contact your doctor or pharmacist.
Croatian: Ako Vaša koža loše reagira na kremu Aldara, prestanite s primjenom, isperite područje blagim sapunom i vodom te se posavjetujte sa svojim liječnikom ili ljekarnikom.
English: Talk to your doctor or pharmacist before using Aldara cream
Croatian: Obratite se svojemu liječniku ili ljekarniku prije nego primijenite Aldara kremu.
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 biološkim testiranjem fotokancerogenosti kod albino atimičnih miševa koji su bili izloženi simuliranom sunčevom ultraljubičastom zračenju.
English: If not washed daily the foreskin may be more likely to show signs of tightness, swelling and wearing away of the skin and result in difficulty in pulling it back.
Croatian: Ako se taj postupak ne ponavlja svakog dana, povećava se mogućnost pojave otvrdnuća, oticanja i guljenja kože, što prouzročuje otežano povlačenje kožice.
English: The risk of severe local skin reactions may be increased when imiquimod is used at higher than recommended doses (see section 4.2).
Croatian: Rizik od teških lokalnih kožnih reakcija veći je pri primjeni imikvimoda u dozi većoj od preporučene (vidjeti dio 4.2).
English: Two open-label, randomised, controlled clinical trials compared the long-term effects of imiquimod with those of topical diclofenac in patients with actinic keratosis with respect to the risk of progression to in situ or invasive squamous cell carcinoma (SCC).
Croatian: Dva otvorena, randomizirana, kontrolirana klinička ispitivanja uspoređivala su dugoročne učinke imikvimoda s učincima topikalnog diklofenaka u bolesnika s aktiničkom keratozom s obzirom na rizik od progresije u in situ ili invazivni karcinom pločastih stanica (engl. squamous cell carcinoma, SCC).