natgillin/translations-raw huggingface dataset:
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.
Odkrili so pomenljivo povezavo med intenzivnostjo lokalnih reakcij na koži (npr. rdečice) v času zdravljenja in popolno odstranitvijo karcinoma bazalnih celic.
The pharmacokinetic properties of imiquimod following single and multiple topical application in paediatric patients with molluscum contagiosum (MC) have been investigated.
Farmakokinetske lastnosti imikvimoda po enkratni in večkratni lokalni uporabi so preiskovali pri otrocih z molluscum contagiosum (MC).
Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod cream use.
Poročali so tudi o lokalni hipopigmentaciji in hiperpigmentaciji po uporabi kreme z imikvimodom.
Whilst using Aldara cream and until healed, the treatment area is likely to appear noticeably different from normal skin.
Med zdravljenjem s kremo Aldara in do dokončne ozdravitve področje zdravljenja verjetno izgleda opazno drugačno od običajne kože.
If you think this applies to you talk to your doctor.
Če se vam zdi, da se to nanaša na vas, se posvetujte z vašim zdravnikom.
Lesions clinically atypical for AK or suspicious for malignancy should be biopsied to determine appropriate treatment.
Za lezije, ki so atipične za AK ali obstaja sum na malignost je potrebno opraviti biopsijo, da se določi primerno zdravljenje.
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.
Aktinične keratoze so področja hrapave kože pri ljudeh, ki so bili prekomerno izpostavljeni soncu.
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.
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.
Imiquimod was investigated in controlled clinical studies with paediatric patients (see sections 4.2 and 5.1).
Raziskave imikvimoda v kontroliranih kliničnih študijah so bile opravljene tudi pri otrocih (glejte poglavji 4.2 in 5.1).
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.
Zbirka podatkov o varnosti uporabe imikvimod kreme pri neobrezanih moških trikrat tedensko z dnevno higieno kožice zajema manj kot 100 bolnikov.
If you decide to have sexual relations while you still have warts, apply Aldara cream after - not before - sexual activity.
Če se odločite za spolne odnose v času, ko še imate bradavice, nanašajte kremo Aldara po spolnem odnosu in ne pred njim.
Imiquimod cream should be washed from the skin before sexual activity.
Imikvimod kremo je potrebno sprati s kože pred spolnim odnosom.
After a 4-week treatment-free period, clearance of AKs should be assessed.
Po štiri tedenskem premoru brez zdravljenja je treba oceniti odpravo AK lezij.
Children and adolescents: Use in children and adolescents is not recommended.
Pri otrocih in mladostnikih: Ne priporoča se uporaba zdravila pri otrocih in mladostnikih.
What Aldara cream looks like and contents of the pack
Izgled kreme Aldara in vsebina pakiranja
Each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods.
Vsako zdravljenje ne sme preseči 4 tednov zaradi pozabljenih odmerkov ali obdobij prekinitve.
Corresponding recurrence rates for vehicle were 47% (8/17 patients) and 7.5% (6/80 lesions).
Stopnja ponovitve pri vehiklu je bila 47 % (8/17 bonikov) in 7,5 % (6/88 lezij).
Saturable binding studies suggest a membrane receptor for imiquimod exists on responding immune cells.
Študije nasičene vezave nakazujejo, da na odzivnih imunskih celicah obstaja membranski receptor za imikvimod.
Some patients have experienced changes in skin colour in the area where Aldara cream was applied.
Pri nekaterih bolnikih se je na področju nanosa kreme Aldara spremenila barva kože.
What you need to know before you use Aldara cream
Kaj morate vedeti, preden boste uporabili kremo Aldara
If you notice any of these symptoms, tell your doctor.
V kolikor opazite kateregakoli teh znakov obvestite svojega zdravnika.
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.
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.
Hands should be washed carefully before and after application of cream.
Roke je potrebno skrbno umiti pred in po nanašanju kreme.
Some systemic adverse reactions, including headache (3.7%), influenza-like symptoms (1.1%), and myalgia (1.5%) were also reported.
Poročali so tudi o nekaterih sistemskih neželenih učinkih, med drugim tudi o glavobolu (3,7 %), simptomih podobnih gripi (1,1 %) in mialgiji (1,5 %).
Before applying imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly.
Pred nanašanjem imikvimod kreme si mora bolnik umiti področje za zdravljenje z blagim milom in vodo ter ga temeljito posušiti.
During this period, showering and bathing should be avoided.
V tem času se je potrebno izogibati tuširanju ali kopanju.
Many of the undesirable effects of Aldara cream are due to its local action on your skin.
Večina neželenih učinkov kreme Aldara izvira iz njenega lokalnega delovanja na kožo.
No clinical experience exists in patients with recurrent and previously treated BCCs, therefore use for previously treated tumours is not recommended.
Ni kliničnih izkušenj pri bolnikih s povratnimi ali že zdravljenimi BCC, zato uporaba imikvimod kreme pri predhodno zdravljenih tumorjih ni priporočljiva.
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.
V preskušanja je bilo vključenih skupno 482 bolnikov, od katerih jih je 481 prejemalo študijsko zdravilo, in sicer 243 imikvimod, 238 pa topični diklofenak.
The most clinically serious adverse event reported following multiple oral doses of  200 mg was hypotension which resolved following oral or intravenous fluid administration.
Klinično najresnejši neželeni učinek po večkratnih peroralnih odmerkih  200 mg je bila hipotenzija, ki je izzvenela po peroralnem in intravenskem dajanju tekočin.
d) Adverse events applicable to all indications:
d) Neželeni učinki, ki se pojavljajo pri vseh indikacijah:
• Do not use Aldara cream until the area to be treated has healed after previous drug or surgical treatment.
• Ne uporabite kreme Aldara, dokler se področje za zdravljenje ne zaceli po predhodnem zdravljenju ali kirurškem posegu.
After this period it is essential that imiquimod cream is removed with mild soap and water.
Po tem obdobju je nujno, da imikvimod kremo odstranimo z blagim milom in vodo.
Do not breast-feed your infant during treatment with Aldara cream, as it is not known whether imiquimod is secreted in human milk.
Med zdravljenjem s kremo Aldara ne smete dojiti, ker ni znano ali imikvimod prehaja v materino mleko.
There was no evidence for systemic reactions.
Ni podatkov o sistemskih učinkih.
The efficacy of imiquimod 5 times per week for 6 weeks was studied in two double-blind vehicle controlled clinical trials.
Učinkovitost imkvimoda petkrat tedensko za 6 tednov je bila raziskana v dveh dvojno slepih kliničnih preskušanjih, nadzorovanih z nosilcem.
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.
Odobrenih indikacij, tj. genitalnih bradavic, aktinične keratoze in površinskega karcinioma bazalnih celic navadno ne opazimo pri otrocih in jih niso preučevali.
In the event of accidental contact, remove cream by rinsing with water.
V primeru nezgodnega stika kremo odstranite s spiranjem z vodo.
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.
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.
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.
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.
The application frequency and duration of treatment with imiquimod cream is different for each indication.
Pogostnost nanašanja in trajanje zdravljenja z imikvimod kremo sta odvisna od indikacije.
While serious sequelae have not resulted, the possibility of infection in broken skin should always be considered.
Čeprav ni prišlo do resnih posledic, se je vedno potrebno zavedati možnosti okužbe razpokane oz. poškodovane kože.
• Tell your doctor if you have an abnormal blood count.
• Obvestite vašega zdravnika v kolikor imate zmanjšano število krvnih celic.
For quantity to be applied see section 4.2 Method of administration.
Za količino kreme, ki jo je treba nanesti glejte poglavje 4.2 Način uporabe.
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).
Preobilno nanašanje kreme ali dolgotrajen stik s kožo lahko povzroči hudo reakcijo na mestu nanosa (glejte poglavja 4.4, 4.8 in 4.9).
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.
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).
Should an intolerable skin reaction occur, the cream should be removed by washing the area with mild soap and water.
Če se razvije neznosna kožna reakcija, se mora kremo odstraniti z umivanjem z blagim milom in vodo.
Animals were administered imiquimod cream three times per week and were irradiated 5 days per week for 40 weeks.
Živalim je bil imikvimod dajan trikrat tedensko, obsevane pa so bile 5 dni tedensko za 40 tednov.
If the treated AK field was not completely cleared of lesions, additional treatment cycles could be started.
Če lezije na zdravljenem AK predelu niso v celoti izginile, so lahko začeli z dodatnimi cikli zdravljenja.
There are no data available on the use of imiquimod in children and adolescents in the approved indications.
Za uporabo imikvimoda za odobrene indikacije pri otrocih in mladostnikih ni podatkov.
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.
Omejeni podatki so pokazali, da se z imikvimod kremo pri HIV pozitivnih bolnikih bradavice hitreje manjšajo, vendar je to zdravilo manj učinkovito pri odstranjevanju bradavic v tej skupini bolnikov.
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.
Če se pri kontrolnem pregledu, ki se opravi približno 8 tednov po zadnjem 4-tedenskem zdravljenju, opazi, da lezije na zdravljenem predelu niso povsem izginile, je treba razmisliti o dodatnem 4-tedenskem zdravljenju z zdravilom Aldara.
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.
Nanesite dovolj kreme, da prekrije področje zdravljenja in en centimeter kože okoli področja zdravljenja, in sicer pet zaporednih dni v tednu skozi 6 tednov.
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.
Pri teh bolnikih moramo upoštevati ravnovesje koristi zdravljenja z imikvimodom in tveganja, povezanega z možnim poslabšanjem avtoimunske bolezni.
If you accidentally swallow Aldara cream please contact your doctor.
Če ste pomotoma zaužili kremo Aldara, se posvetujte z zdravnikom.
In those imiquimod patients who achieved total clearance of their warts, the median time to clearance was 12 weeks.
Pri tistih bolnikih, ki so dosegli popolno odstranitev bradavic, je bila mediana časa do odstranitve 12 tednov.
Superficial basal cell carcinoma (5x/wk, 6 wks) N = 185
Površinski karcinom bazalnih celic (5x tedensko, 6 tednov) n = 185
In those imiquimod patients who achieved total clearance of their warts, the median time to clearance was 8 weeks.
Pri tistih bolnicah, ki so dosegle popolno odstranitev bradavic, je bila mediana časa do odstranitve 8 tednov.
Discard any cream remaining in a sachet after use.
Zavrzite kremo, ki ostane v vrečki po uporabi.
External genital warts (3x/ wk,16wks) N = 2292
Zunanje genitalne bradavice (3x tedensko/16 tednov) n = 2292
This includes studies with immunosuppressive drugs.
Študij medsebojnega delovanja niso izvedli, vključno s imunosupresivnimi zdravili.
- Each Aldara 5% cream sachet contains 250 mg of a white to slightly yellow cream.
- Vrečka Aldara 5 % kreme vsebuje 250 mg bele do rahlo rumene kreme.
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.
Če vaša koža resno reagira na uporabo kreme Aldara, prenehajte z uporabo, umijte področje nanosa z blagim milom in vodo ter čim prej obvestite svojega zdravnika ali farmacevta.
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.
Pri 162 bolnikih, ki so jih opazovali pet let po zdravljenju sBCC, so ugotovili, da je imelo 37 % bolnikov blago hipopigmentacijo, 6 % zmerno, pri 56 % bolnikov pa niso opazili sprememb.
Imiquimod is an immune response modifier.
Imikvimod je modulator imunskega odziva.
• If you are being treated for basal cell carcinoma or actinic keratosis follow these additional precautions:
• Če se zdravite zaradi karcinoma bazalnih celic ali aktiničnih keratoz, upoštevajte naslednje dodatne previdnostne ukrepe:
Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with Aldara cream.
Med zdravljenjem s kremo Aldara ne uporabljajte svetilk za sončenje ali solarijev ter se izogibajte sončni svetlobi, kolikor je možno.
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.
Vendar ima imikvimod pri ljudeh majhno sistemsko absorpcijo s kože in ni mutagen, zato je tveganje za človeka, ki bi izviralo iz sistemske izpostavitve, verjetno nizko.
Early signs of stricture may include local skin reactions (e.g. erosion, ulceration, oedema, induration), or increasing difficulty in retracting the foreskin.
Zgodnji znaki strikture so lahko lokalne reakcije na koži (npr. erozija, ulceracija, oteklina, otrdlina) ali čedalje težje premikanje kožice.
If a dose is missed, the patient should apply the cream as soon as he/she remember and then he/she should continue with the regular schedule.
Če bolnik pozabi odmerek, mora kremo takoj nanesti, ko se spomni, in nadaljuje po rednem urniku.
No clinical experience exists with imiquimod cream immediately following treatment with other cutaneously applied drugs for treatment of external genital or perianal warts.
Ni kliničnih izkušenj z uporabo imikvimod kreme neposredno po zdravljenju zunanjih genitalnih ali perianalnih bradavic z drugimi zdravili, ki se uporabljajo topično.
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.
Podatki iz odprtega kliničnega preskušanja so pokazali, da je bila stopnja popolnega izginotja pri preiskovancih z več kot 8 AK manjša kot pri preiskovancih z manj kot 8 AK.
Rectal tenesmus
Rektalni tenezem
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)
Pri aplikaciji na poškodovani koži lahko pride do povečane sistemske absorbcije imikvimoda, ki lahko poveča tveganje nastanka škodljivih posledic (glejte poglavji 4.8 in 4.9).
Sufficient cream should be applied to cover the treatment area, including one centimetre of skin surrounding the tumour.
Nanesti je potrebno dovolj kreme, da prekrije področje za zdravljenje in en centimeter kože okoli tumorja.
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).
Ta predpisana vrednotenja kliničnih znakov so pokazala, da so bile lokalne reakcije na koži, vključno z rdečico (61 %), erozijo (30 %), lupljenjem/luskavostjo (23 %) in oteklino (14 %), pogoste v teh s placebom nadzorovanih preskušanjih, kjer je bila imikvimod krema nanešena trikrat tedensko (glejte poglavje 4.4).
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.
Ker po enkratnem in večkratnem topičnem odmerku v serumu ni zaznavnih koncentracij imikvimoda (> 5 ng/ml), ni mogoče podati specifičnih nasvetov o uporabi pri doječih materah.
Aldara cream may weaken condoms and diaphragms, therefore the cream should not be left on during sexual activity.
Krema Aldara lahko oslabi kondome in diafragme, zato morate kremo sprati pred spolnim odnosom.
In clinical trials of imiquimod cream 3 times weekly for 4 or 8 weeks the most frequently occurring application site reactions were itching at the target site (14%) and burning at the target site (5%).
Pri kliničnih preskušanjih z imikvimod kremo 3 krat tedensko v času 4 ali 8 tednov so bile najpogosteje opažene reakcije na mestu aplikacije srbečica (14 %) in pekoč občutek (5 %).
Investigators of placebo controlled trials were required to evaluate protocol mandated clinical signs (skin reactions).
Raziskovalci so v preskušanjih, nadzorovanih s placebom, morali oceniti s protokolom predpisane klinične znake (reakcije na koži).
- Each box contains 12 or 24 single-use polyester/aluminium foil sachets.
- V škatlici je 12 ali 24 vrečk za enkratno uporabo iz poliesterske/aluminijske folije.
• If you are being treated for genital warts follow these additional precautions:
• Če se zdravite zaradi bradavic, upoštevajte naslednje dodatne previdnostne ukrepe:
Imiquimod is not recommended for the treatment of AK lesions with marked hyperkeratosis or hypertrophy as seen in cutaneous horns.
Imikvimod ni priporočljiv za zdravljenje lezij AK z izrazito hiperkeratozo ali hipertrofijo, kot je npr. kožni rog.
If a skin reaction becomes too uncomfortable during treatment, speak to your doctor.
Če kožna reakcija povzroči prekomerno nelagodje, se posvetujte z zdravnikom.
Serious skin reactions reported from postmarketing experience include erythema multiforme, Stevens Johnson syndrome and cutaneous lupus erythematosus.
Od začetka trženja so poročali o resnih kožnih reakcijah, vključno z multiformnim eritemom, eksantemom, Stevens Johnsonovim sindromom ali kožnim eritematoznim lupusom.
The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 12 weeks after the end of treatment.
Klinični izid zdravljenja se lahko oceni po regeneraciji zdravljene kože, ki traja približno 12 tednov po zaključku zdravljenja.
If the lesions have not all disappeared, further four weeks of treatment may be necessary.
Če lezije niso popolnoma izginile, se boste morda morali zdraviti še dodatne štiri tedne.
Each containing 250 mg of cream.
Vsaka vsebuje 250 mg kreme.
Imiquimod has not been evaluated for the treatment of actinic keratoses on the eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border.
Uporaba imikvimoda ni raziskana za zdravljenje aktiničnih keratoz na očesnih vekah, v nosnicah, v ušesu, na področju ustnic znotraj meje s kožo.
Methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed).
Metilparahidroksibenzoat (E 218) in propilparahidroksibenzoat (E 216) lahko povzročita alergijske reakcije (možno zakasnjene).
Apart from reactions in the skin, other common effects include swollen glands and back pain.
Poleg reakcij na koži so bili drugi pogosti učinki otekle žleze in bolečine v križu.
Use in children and adolescents is not recommended.
Uporaba zdravila pri otrocih in mladostnikih se ne priporoča.
ALDARA 5% cream
ALDARA 5 % krema
After application of the cream, throw away the opened sachet and wash hands with soap and water.
Po nanosu kreme zavrzite odprto vrečko in si umijte roke z milom in vodo.
You might also feel itching (32% patients), a burning sensation (26% patients) or pain in areas where you have applied Aldara cream (8% patients).
Na področju, kjer ste nanesli kremo Aldara, se lahko razvije tudi srbečica (32 % bolnikov), pekoč občutek (26 % bolnikov) ali bolečina (8 % bolnikov).
Metabolism and nutrition disorders: Anorexia
Presnovne in prehranske motnje: Anoreksija pogosti
Patients had clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions on the balding scalp or face within a contiguous 25 cm treatment area.
V obeh raziskavah so imeli bolniki klinično tipične, vidne, ločene, nehiperkeratotične, nehipertrofične lezije AK v neprekinjenem področju zdravljenja 25 cm na lasišču ali obrazu.
Sachets should not be re-used once opened.
Ko so vrečke enkrat odprte, se ne smejo ponovno uporabiti.
Boxes of 12 or 24 single-use polyester/aluminium foil sachets, containing 250 mg of cream.
Škatla po 12 ali 24 vrečk za enkratno uporabo iz poliesterske/aluminijske folije, vsaka vsebuje 250 mg kreme.
If there is pus (matter) or other suggestion of infection, discuss this with your doctor.
Če se pojavi gnoj ali drug znak okužbe, se posvetujte z zdravnikom.
In immunocompromised patients, repeat treatment with imiquimod cream is not recommended.
Pri imunsko oslabljenih bolnikih ponavljanje zdravljenja z imikvimod kremo ni priporočljivo.
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
Pomožne snovi z znanim učinkom: metilparahidroksibenzoat (E218) 2,0 mg/g kreme propilparahidroksibenzoat (E216) 0,2 mg/g kreme cetilalkohol 22,0 mg/g kreme stearilalkohol 31,0 mg/g kreme benzilalkohol 20,0 mg/g kreme