FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Na živalskih modelih je imikvimod učinkovit proti virusnim okužbam in deluje protitumorsko, predvsem zaradi spodbujanja interferona alfa in drugih citokinov.
English: For imiquimod no clinical data on exposed pregnancies are available.
Slovenian: Za imikvimod ni na voljo kliničnih podatkov nosečnic, ki so bile izpostavljene zdravilu.
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.
Slovenian: Navidezna razpolovna doba, ki je bila izračunana, je bila približno desetkrat večja kot dvourna razpolovna doba po subkutanem odmerjanju v predhodni raziskavi, kar nakazuje podaljšano zadrževanje zdravila v koži.
English: Furthermore, tumours were not seen at any site in a 2-year oral carcinogenicity study in rats.
Slovenian: Poleg tega, se tumorji niso pojavili na nobenem mestu v dvoletni študiji kancerogenosti pri podganah pri peroralnem dajanju.
English: If the treated tumour shows an incomplete response, a different therapy should be used (see section 4.4).
Slovenian: Če zdravljeni tumor ne kaže popolnega odziva, je potrebno uporabiti drugačno zdravljenje (glejte poglavje 4.4).
English: Open a new sachet and squeeze some cream onto your fingertip.
Slovenian: Odprite novo vrečko in iztisnite nekaj kreme na konico prsta.
English: Reductions in haematological parameters requiring clinical intervention have been reported from postmarketing experience.
Slovenian: O znižanju hematoloških parametrov, ki so zahtevali klinično intervencijo, so poročali v času trženja zdravila.
English: In some individuals a lowering of blood counts was noted.
Slovenian: Pri nekaterih bolnikih so zasledili zmanjšanje števila krvnih celic.
English: During the 6 to 10 hour treatment period, showering or bathing should be avoided.
Slovenian: V 6 do 10 urah po nanosu se moramo izogibati tuširanju ali kopanju.
English: The risk of severe local skin reactions may be increased when imiquimod is used at higher than recommended doses (see section 4.2).
Slovenian: Tveganje za hude lokalne reakcije na koži se lahko poveča, če se imikvimod nanaša v odmerkih, ki so večji od priporočenih (glejte poglavje 4.2).
English: Inflammation c) Frequently occurring adverse events:
Slovenian: Vnetje c) Pogostejši neželeni učinki:
English: Persistent dermal overdosing of imiquimod cream could result in severe local skin reactions.
Slovenian: Vztrajno prekomerno dermalno odmerjanje imikvimod kreme lahko povzroči hude lokalne reakcije na koži.
English: EU/1/98/080/001 12 sachets EU/1/98/080/002 24 sachets
Slovenian: EU/1/98/080/001 12 vrečk EU/1/98/080/002 24 vrečk 13.
English: Mylan Medical SAS 40-44 rue Washington
Slovenian: Mylan Medical SAS 40-44 rue Washington 75008 Paris
English: What Aldara cream is and what it is used for
Slovenian: Kaj je krema Aldara in za kaj jo uporabljamo
English: If you have open sores: do not start using Aldara cream until after the sores have healed.
Slovenian: Če imate odprte rane: ne uporabljajte kreme Aldara, dokler se rane ne zacelijo.
English: Influenza-like illness
Slovenian: Bolezen podobna gripi
English: If you have the impression that the effect of Aldara cream is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek kreme Aldara premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: Benzyl alcohol may cause allergic reactions and mild local irritation.
Slovenian: Benzilalkohol lahko povzroči alergijske reakcije in blago lokalno draženje.
English: Most of these skin reactions are mild and the skin will return to normal within about 2 weeks after stopping treatment.
Slovenian: Večina teh kožnih reakcij je blagih in se bo koža normalizirala v približno 2 tednih po prekinitvi zdravljenja.
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.
Slovenian: Na voljo je zelo omejena količina podatkov o uporabi imikvimoda za zdravljenje aktiničnih keratoz drugje kot na obrazu in lasišču.
English: An interruption of dosing should be considered.
Slovenian: V takem primeru razmislimo o prekinitvi odmerjanja.
English: A lowering of blood counts might make you more susceptible to infections, make you bruise more easily or cause fatigue.
Slovenian: Zaradi zmanjšanega števila krvnih celic ste lahko bolj občutljivi za infekcije, pojavijo se lahko modrice in lahko ste bolj utrujeni.
English: Frequencies are defined as Very common (1/10), Common (1/100 to <1/10) and Uncommon (1/1,000 to <1/100).
Slovenian: Pogostnost neželenih učinkov je definirana kot zelo pogosti (≥1/10), pogosti (≥1/100, <1/10), občasni (≥1/1.000, <1/100).
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.
Slovenian: • klinično tipičnih nehiperkeratotičnih, nehipertrofičnih aktiničnih keratoz (AK) na obrazu in lasišču pri odraslih bolnikih, ko je velikost ali število lezij tolikšno, da ni uspešna ali/in sprejemljiva krioterapija in so drugi načini zdravljenja kontraindicirani ali pa so manj primerni.
English: The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 4-8 weeks after the end of treatment.
Slovenian: Klinični izid zdravljenja se lahko oceni po regeneraciji zdravljene kože, približno 4-8 tednov po končanem zdravljenju.
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.
Slovenian: Zdravljenje z imikvimod kremo naj traja dokler ne izginejo vidne genitalne ali perianalne bradavice oziroma najdlje 16 tednov za vsako ponovitev bradavic.
English: Other medicines and Aldara cream
Slovenian: Druga zdravila in krema Aldara
English: Only apply to affected areas and avoid any application on internal surfaces.
Slovenian: Kremo nanašamo le na prizadeto področje in se izogibamo nanašanju na notranje površine.
English: The complete clearance rate (imiquimod minus placebo) for the combined trials was 46.1% (CI 39.0%,
Slovenian: Stopnja popolnega izginotja (imikvimod minus placeba) pri združenih preizkušanjih je bila 46,1 % (IZ 39,0 %, 53,1 %).
English: These reactions were at non-wart sites which may have been in contact with imiquimod cream.
Slovenian: Te reakcije so se razvile na mestih brez bradavic, ki so bila lahko v stiku z imikvimod kremo.
English: A rest period of several days may be taken (see section 4.4) if the local skin reaction to imiquimod cream causes excessive discomfort to the patient, or if infection is observed at the treatment site.
Slovenian: Zdravljenje je potrebno za nekaj dni prekiniti (glejte poglavje 4.4), če lokalna kožna reakcija na imikvimod kremo povzroči prekomerno nelagodje bolnika ali če se na področju zdravljenja razvije okužba.
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).
Slovenian: V dveh odprtih, randomiziranih, kontroliranih kliničnih študijah so primerjali dolgoročne učinke imikvimoda z dolgoročnimi učinki topičnega diklofenaka pri bolnikih z aktinično keratozo v zvezi s tveganjem za napredovanje v in situ ali invazivni ploščatocelični karcinom (SCC).
English: The treatment frequency and duration differ for genital warts, basal cell carcinoma and actinic keratosis (see specific instructions for each indication).
Slovenian: Pogostnost in trajanje zdravljenja genitalnih bradavic, karcinoma bazalnih celic in aktinične keratoze se razlikuje (glejte podrobna navodila za vsako indikacijo).
English: Before going to bed, wash your hands and the treatment area with mild soap and water.
Slovenian: Preden se odpravite spat, si umijte roke in mesto zdravljenja z milom in vodo.
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).
Slovenian: Aktinične keratoze, ki so po enem ali dveh ciklih zdravljenja izginile in se nato ponovno pojavile, je mogoče ponovno zdraviti s še enim ali dodatnima dvema cikloma zdravljenja s kremo Aldara po najmanj 12-tedenskem odmoru brez zdravljenja (glejte poglavje 5.1).
English: Very common effects include redness (61% patients), wearing away of the skin (30% patients), flakiness and swelling.
Slovenian: Zelo pogosti neželeni učinki so rdečica (61 % bolnikov), oguljena koža (30 % bolnikov), luskavost in oteklina.
English: Sufficient cream should be applied to cover the treatment area.
Slovenian: Nanesti je potrebno dovolj kreme, da prekrije področje za zdravljenje.
English: However the cream should not be applied more than once a day.
Slovenian: Kreme se ne nanaša več kot enkrat dnevno.
English: If you miss a dose, apply cream as soon as you remember and then continue in your regular schedule.
Slovenian: Če ste pozabili nanesti kremo, jo nanesite takoj, ko se spomnite, in nadaljujte po rednem urniku.
English: For example, apply the cream on Monday, Wednesday and Friday.
Slovenian: Kremo nanesite npr. v ponedeljek, sredo in petek.
English: Herpes simplex
Slovenian: Herpes simpleks
English: During therapy and until healed, affected skin is likely to appear noticeably different from normal skin.
Slovenian: Med zdravljenjem in do dokončne ozdravitve prizadeta koža verjetno izgleda opazno drugačna od običajne kože.
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.
Slovenian: V študijah, kjer se dnevna higiena kožice penisa ni uveljavljala, so zabeležili dva primera hude fimoze in en primer strikture, ki so zahtevali obrezovanje.
English: They can be flat and scaly, or raised, rough, hard and warty.
Slovenian: Lahko so ravne in luskaste ali hrapave, trde in bradavičaste.
English: Clinical studies investigating the use of imiquimod for the treatment of actinic keratosis have detected a 0.4% (5/1214) frequency of alopecia at the treatment site or surrounding area.
Slovenian: V kliničnih preskušanjih, kjer so raziskovali uporabo imikvimoda za zdravljenje aktinične keratoze, so odkrili 0,4 % (5/1214) pogostnost alopecije na mestu zdravljenja ali okolišnjem področju.
English: A two-year mouse carcinogenicity study by dermal administration on three days a week did not induce tumours at the application site.
Slovenian: V dvoletni študiji kancerogenosti na miših z dermalnim nanašanjem tri dni na teden, zdravilo ni sprožilo nastanka tumorjev na mestu nanašanja.
English: • Small superficial basal cell carcinomas (sBCCs) in adults.
Slovenian: • majhnih površinskih karcinomov bazalnih celic (sBCCs) pri odraslih bolnikih
English: There are no medicines known to be incompatible with Aldara cream.
Slovenian: Zdravila, ki bi bila nezdružljiva s kremo Aldara, niso znana.
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.
Slovenian: Odkrili so pomenljivo povezavo med intenzivnostjo lokalnih reakcij na koži (npr. rdečice) v času zdravljenja in popolno odstranitvijo karcinoma bazalnih celic.
English: The pharmacokinetic properties of imiquimod following single and multiple topical application in paediatric patients with molluscum contagiosum (MC) have been investigated.
Slovenian: Farmakokinetske lastnosti imikvimoda po enkratni in večkratni lokalni uporabi so preiskovali pri otrocih z molluscum contagiosum (MC).
English: Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod cream use.
Slovenian: Poročali so tudi o lokalni hipopigmentaciji in hiperpigmentaciji po uporabi kreme z imikvimodom.
English: Whilst using Aldara cream and until healed, the treatment area is likely to appear noticeably different from normal skin.
Slovenian: Med zdravljenjem s kremo Aldara in do dokončne ozdravitve področje zdravljenja verjetno izgleda opazno drugačno od običajne kože.
English: If you think this applies to you talk to your doctor.
Slovenian: Če se vam zdi, da se to nanaša na vas, se posvetujte z vašim zdravnikom.
English: Lesions clinically atypical for AK or suspicious for malignancy should be biopsied to determine appropriate treatment.
Slovenian: Za lezije, ki so atipične za AK ali obstaja sum na malignost je potrebno opraviti biopsijo, da se določi primerno zdravljenje.
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.
Slovenian: Aktinične keratoze so področja hrapave kože pri ljudeh, ki so bili prekomerno izpostavljeni soncu.
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.
Slovenian: Podatki o sistemski izpostavljenosti so pokazali, da je absorbcija imikvimoda po lokalni uporabi na koži, poškodovani zaradi MC, pri otrocih od 6 - 12 let nizka in primerljiva z absorbcijo pri zdravih odraslih in odraslih z aktinično keratozo in površinskim karcinomom bazalnih celic.
English: Imiquimod was investigated in controlled clinical studies with paediatric patients (see sections 4.2 and 5.1).
Slovenian: Raziskave imikvimoda v kontroliranih kliničnih študijah so bile opravljene tudi pri otrocih (glejte poglavji 4.2 in 5.1).
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.
Slovenian: Zbirka podatkov o varnosti uporabe imikvimod kreme pri neobrezanih moških trikrat tedensko z dnevno higieno kožice zajema manj kot 100 bolnikov.
English: If you decide to have sexual relations while you still have warts, apply Aldara cream after - not before - sexual activity.
Slovenian: Če se odločite za spolne odnose v času, ko še imate bradavice, nanašajte kremo Aldara po spolnem odnosu in ne pred njim.
English: Imiquimod cream should be washed from the skin before sexual activity.
Slovenian: Imikvimod kremo je potrebno sprati s kože pred spolnim odnosom.
English: After a 4-week treatment-free period, clearance of AKs should be assessed.
Slovenian: Po štiri tedenskem premoru brez zdravljenja je treba oceniti odpravo AK lezij.
English: Children and adolescents: Use in children and adolescents is not recommended.
Slovenian: Pri otrocih in mladostnikih: Ne priporoča se uporaba zdravila pri otrocih in mladostnikih.
English: What Aldara cream looks like and contents of the pack
Slovenian: Izgled kreme Aldara in vsebina pakiranja
English: Each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods.
Slovenian: Vsako zdravljenje ne sme preseči 4 tednov zaradi pozabljenih odmerkov ali obdobij prekinitve.
English: Corresponding recurrence rates for vehicle were 47% (8/17 patients) and 7.5% (6/80 lesions).
Slovenian: Stopnja ponovitve pri vehiklu je bila 47 % (8/17 bonikov) in 7,5 % (6/88 lezij).
English: Saturable binding studies suggest a membrane receptor for imiquimod exists on responding immune cells.
Slovenian: Študije nasičene vezave nakazujejo, da na odzivnih imunskih celicah obstaja membranski receptor za imikvimod.
English: Some patients have experienced changes in skin colour in the area where Aldara cream was applied.
Slovenian: Pri nekaterih bolnikih se je na področju nanosa kreme Aldara spremenila barva kože.
English: What you need to know before you use Aldara cream
Slovenian: Kaj morate vedeti, preden boste uporabili kremo Aldara
English: If you notice any of these symptoms, tell your doctor.
Slovenian: V kolikor opazite kateregakoli teh znakov obvestite svojega zdravnika.
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.
Slovenian: Informacije o ponovnem zdravljenju aktiničnih keratoz, ki so se pojavile po tem, ko so po enem ali dveh ciklusih zdravljenja že izginile, so navedene v poglavjih 4.2 in 5.1.
English: Hands should be washed carefully before and after application of cream.
Slovenian: Roke je potrebno skrbno umiti pred in po nanašanju kreme.
English: Some systemic adverse reactions, including headache (3.7%), influenza-like symptoms (1.1%), and myalgia (1.5%) were also reported.
Slovenian: Poročali so tudi o nekaterih sistemskih neželenih učinkih, med drugim tudi o glavobolu (3,7 %), simptomih podobnih gripi (1,1 %) in mialgiji (1,5 %).
English: Before applying imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly.
Slovenian: Pred nanašanjem imikvimod kreme si mora bolnik umiti področje za zdravljenje z blagim milom in vodo ter ga temeljito posušiti.
English: During this period, showering and bathing should be avoided.
Slovenian: V tem času se je potrebno izogibati tuširanju ali kopanju.
English: Many of the undesirable effects of Aldara cream are due to its local action on your skin.
Slovenian: Večina neželenih učinkov kreme Aldara izvira iz njenega lokalnega delovanja na kožo.
English: No clinical experience exists in patients with recurrent and previously treated BCCs, therefore use for previously treated tumours is not recommended.
Slovenian: Ni kliničnih izkušenj pri bolnikih s povratnimi ali že zdravljenimi BCC, zato uporaba imikvimod kreme pri predhodno zdravljenih tumorjih ni priporočljiva.
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.
Slovenian: V preskušanja je bilo vključenih skupno 482 bolnikov, od katerih jih je 481 prejemalo študijsko zdravilo, in sicer 243 imikvimod, 238 pa topični diklofenak.
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.
Slovenian: Klinično najresnejši neželeni učinek po večkratnih peroralnih odmerkih  200 mg je bila hipotenzija, ki je izzvenela po peroralnem in intravenskem dajanju tekočin.
English: d) Adverse events applicable to all indications:
Slovenian: d) Neželeni učinki, ki se pojavljajo pri vseh indikacijah:
English: • Do not use Aldara cream until the area to be treated has healed after previous drug or surgical treatment.
Slovenian: • Ne uporabite kreme Aldara, dokler se področje za zdravljenje ne zaceli po predhodnem zdravljenju ali kirurškem posegu.
English: After this period it is essential that imiquimod cream is removed with mild soap and water.
Slovenian: Po tem obdobju je nujno, da imikvimod kremo odstranimo z blagim milom in vodo.
English: Do not breast-feed your infant during treatment with Aldara cream, as it is not known whether imiquimod is secreted in human milk.
Slovenian: Med zdravljenjem s kremo Aldara ne smete dojiti, ker ni znano ali imikvimod prehaja v materino mleko.
English: There was no evidence for systemic reactions.
Slovenian: Ni podatkov o sistemskih učinkih.
English: The efficacy of imiquimod 5 times per week for 6 weeks was studied in two double-blind vehicle controlled clinical trials.
Slovenian: Učinkovitost imkvimoda petkrat tedensko za 6 tednov je bila raziskana v dveh dvojno slepih kliničnih preskušanjih, nadzorovanih z nosilcem.
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.
Slovenian: Odobrenih indikacij, tj. genitalnih bradavic, aktinične keratoze in površinskega karcinioma bazalnih celic navadno ne opazimo pri otrocih in jih niso preučevali.
English: In the event of accidental contact, remove cream by rinsing with water.
Slovenian: V primeru nezgodnega stika kremo odstranite s spiranjem z vodo.
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.
Slovenian: Bolniki s ponavljajočimi AK lezijami (kot so opredeljene zgoraj), ki so se pojavile na predelu s predhodno popolno ozdravitvijo, so imeli približno 80-odstotno možnost ponovne popolne odprave lezij po dodatnem ciklusu zdravljenja z imikvimodom, medtem ko je bila ta možnost pri ponovnem zdravljenju s topičnim diklofenakom približno 50-odstotna.
English: These protocol mandated clinical sign assessments indicate that severe erythema (31%) severe erosions (13%) and severe scabbing and crusting (19%) were very common in these trials with imiquimod cream applied 5 times weekly.
Slovenian: Vrednotenje v protokolu navedenih kliničnih znakov je pokazalo, da so bile huda rdečica (31 %), huda erozija (13 %) in huda luskavost ter tvorba krast (19 %) zelo pogoste v teh preskušanjih, kjer je bila imikvimod krema nanešena petkrat tedensko.
English: The application frequency and duration of treatment with imiquimod cream is different for each indication.
Slovenian: Pogostnost nanašanja in trajanje zdravljenja z imikvimod kremo sta odvisna od indikacije.
English: While serious sequelae have not resulted, the possibility of infection in broken skin should always be considered.
Slovenian: Čeprav ni prišlo do resnih posledic, se je vedno potrebno zavedati možnosti okužbe razpokane oz. poškodovane kože.
English: • Tell your doctor if you have an abnormal blood count.
Slovenian: • Obvestite vašega zdravnika v kolikor imate zmanjšano število krvnih celic.
English: For quantity to be applied see section 4.2 Method of administration.
Slovenian: Za količino kreme, ki jo je treba nanesti glejte poglavje 4.2 Način uporabe.
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).
Slovenian: Preobilno nanašanje kreme ali dolgotrajen stik s kožo lahko povzroči hudo reakcijo na mestu nanosa (glejte poglavja 4.4, 4.8 in 4.9).
English: Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with the possibility of organ rejection or graft-versus-host disease.
Slovenian: Pri teh bolnikih moramo upoštevati ravnovesje koristi zdravljenja z imikvimodom in tveganja, povezanega z možno zavrnitvijo presadka ali boleznijo presadka proti gostitelju (graft-versus-host disease).
English: Should an intolerable skin reaction occur, the cream should be removed by washing the area with mild soap and water.
Slovenian: Če se razvije neznosna kožna reakcija, se mora kremo odstraniti z umivanjem z blagim milom in vodo.
English: Animals were administered imiquimod cream three times per week and were irradiated 5 days per week for 40 weeks.
Slovenian: Živalim je bil imikvimod dajan trikrat tedensko, obsevane pa so bile 5 dni tedensko za 40 tednov.
English: If the treated AK field was not completely cleared of lesions, additional treatment cycles could be started.
Slovenian: Če lezije na zdravljenem AK predelu niso v celoti izginile, so lahko začeli z dodatnimi cikli zdravljenja.
English: There are no data available on the use of imiquimod in children and adolescents in the approved indications.
Slovenian: Za uporabo imikvimoda za odobrene indikacije pri otrocih in mladostnikih ni podatkov.