FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen.
English: There have been postmarketing reports of elevated liver enzymes.
Danish: Der findes post-marketingrapporter om forhøjede leverenzymer.
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.
Danish: En patient blev regnet som recidiverende i disse studier hvis mindst en AK-læsion blev observeret i det samlede ophelede område, hvor en recidiverende læsion kunne være en læsion, som forekom på det samme område som tidligere ophelede læsioner, eller en ny identificeret læsion et sted på det behandlede AK-område.
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.
Danish: En patient med recidiverende AK-læsioner (som defineret ovenfor) i det samlede ophelede område havde en chance på ca. 80 % for at opnå fuld opheling igen efter en behandlingsrunde yderligere med imiquimod sammenlignet med en chance på ca. 50 % efter genbehandling med topikal diclofenac.
English: Painful skin reactions at the opening of the vagina have very rarely made it difficult for some women to pass urine.
Danish: Smertefulde reaktioner i skedeåbningen har i meget sjældne tilfælde, har det gjort det vanskeligt for nogle kvinder at tømme blæren.
English: • Small superficial basal cell carcinomas (sBCCs) in adults.
Danish: • Små superficielle basalcellekarcinomer (sBCC) hos voksne
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.
Danish: Behandlingen med imiquimod creme bør fortsætte, indtil synlige vorter ved kønsorganer eller endetarmsåbningen er forsvundet, eller i højst 16 uger pr. vorteepisode.
English: Open a new sachet and squeeze some cream onto your fingertip.
Danish: Åbn et nyt brev og tryk lidt creme ud på fingerspidsen.
English: Severe erythema (24%) and severe scabbing and crusting (20%) were very common.
Danish: Kraftig rødme (24%) og udtalt hudflager og skorpedannelse (20%) var meget almindelige.
English: Children and adolescents: Use in children and adolescents is not recommended.
Danish: Børn og unge: Anbefales ikke til brug til børn og unge.
English: If these symptoms occur, stop the treatment immediately and call your doctor.
Danish: Hvis disse symptomer indtræder, skal De omgående standse behandlingen og kontakte Deres læge.
English: No quantifiable levels (>5 ng/ml) of drug were detected in serum after single or multiple topical doses.
Danish: Ingen kvantitetsbestemte niveauer (> 5 ng/ml) af præparatet blev sporet i serum efter enkelt- eller multipel topisk dosering.
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.
Danish: Information om gentagen behandling af aktinisk keratose læsioner som er forsvundet efter en eller to behandlinger og senere recidiverer gives i afsnit 4.2 og 5.1.
English: Do not use this medication for more than one course if you have problems with your immune system, either due to illness or because of the medicines you are already taking.
Danish: - De bør ikke anvende Aldara creme i mere end én behandlingsperiode, hvis De har alvorlige problemer med immunsystemet, enten på grund af sygdom eller på grund af medicin De allerede får.
English: Mylan Medical SAS 40-44 rue Washington
Danish: Mylan Medical SAS 40-44 rue Washington 75008 Paris
English: The treated AK field was located on the balding scalp or face with a contiguous area of about 40 cm² for both treatment groups presenting with a median number of 7 clinically typical AK lesions at baseline.
Danish: Det behandlede AK-område var et skaldet område af hovedet eller ansigtet og dækkede et samlet område på ca. 40 cm for begge behandlingsgrupper med en median på 7 klinisk typiske AK-læsioner ved baseline.
English: Urinary recovery was less than 0.6% of the applied dose at week 16 in these patients.
Danish: Hos disse patienter var forekomsten i urin mindre end 0,6% af den anvendte dosis ved uge 16.
English: Metabolism and nutrition disorders: Anorexia
Danish: Metabolisme og ernæring Anoreksi
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.
Danish: Data fra et åbent klinisk studie indikerer, at patienter med mere end 8 AK-læsioner udviste nedsat udstrækning af fuldstændig opheling sammenlignet med patienter med mindre end 8 læsioner.
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.
Danish: Effekten af imiquimod, påført 3 gange ugentligt i en eller to behandlings perioder af 4-uger, adskilt af en 4- ugers behandlingsfri periode, blev undersøgt i to dobbeltblindede, vehicel-kontrollerede kliniske studier.
English: During the 6 to 10 hour treatment period, showering or bathing should be avoided.
Danish: I den 6 til 10 timer lange behandlingsperiode skal bruse- og karbad undgås.
English: If the treated tumour shows an incomplete response, a different therapy should be used (see section 4.4).
Danish: Hvis den behandlede tumor udviser utilstrækkelig reaktion på behandlingen, bør en anden behandling anvendes (se pkt.
English: For example, apply the cream on Monday, Wednesday and Friday.
Danish: Påfør for eksempel cremen mandag, onsdag og fredag.
English: Leave Aldara cream on the warts for 6 to 10 hours.
Danish: Lad cremen sidde på vorterne i 6 til 10 timer.
English: Eye disorders Conjunctival irritation
Danish: Øjne Irritation i conjunctiva
English: For example, apply the cream from Monday to Friday.
Danish: De kan for eksempel påføre cremen fra mandag til og med fredag.
English: There is an association between the complete clearance rate and the intensity of local skin reactions (e.g. erythema).
Danish: Der er en forbindelse mellem udstrækningen af fuldstændig opheling og styrken af lokale hudreaktioner (f.eks. erytem).
English: Tumours occurred earlier and in greater number in the group of mice administered the vehicle cream in comparison with the low UVR control group.
Danish: Tumorer opstod tidligere og i større antal i den gruppe, der fik vehikelcremen, sammenlignet med kontrolgruppen på lav UVR.
English: If this occurs you should seek medical help immediately.
Danish: Hvis dette sker for Dem, bør De omgående søge læge.
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.
Danish: Tilgængelige data vedrørende aktinisk keratose på underarm og hænder peger ikke på nogen effekt, og en sådan anvendelse anbefales derfor ikke.
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.
Danish: Den lille mængde lægemiddel, som blev absorberet i det systemiske kredsløb, blev straks udskilt både med urinen og fæces med en gennemsnitskvotient på cirka 3 til 1.
English: Actinic keratosis in adults
Danish: Aktinisk keratose hos voksne
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.
Danish: Hvis Deres hud reagerer kraftigt, når De anvender Aldara creme, skal De holde op med at bruge cremen, vaske området med en mild sæbe og vand og kontakte lægen eller apoteket.
English: Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Danish: Cetylalkohol og stearylalkohol kan forårsage lokale hudreaktioner (f.eks. kontakt dermatitis).
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.
Danish: Det klinisk mest alvorlige indberettede tilfælde af bivirkninger, som fulgte efter flere orale doser på  200 mg, var hypotension, som svandt efter oral eller intravenøs væsketilførsel.
English: Interactions with systemic drugs would be limited by the minimal percutaneous absorption of imiquimod cream.
Danish: Interaktioner med systemiske lægemidler vil være begrænset af den minimale absorption af imiquimod creme.
English: • Avoid contact with the eyes, lips and nostrils.
Danish: o Undgå kontakt med øjnene, læber og næsebor.
English: d) Adverse events applicable to all indications:
Danish: d) Bivirkninger for alle indikationer:
English: ● If you are being treated for genital warts: Many of the undesirable effects of Aldara cream are due to its local action on your skin.
Danish: ●Hvis De behandles for kønsvorter: Mange af Aldaras uønskede virkninger skyldes lægemidlets lokale virkning på huden.
English: Imiquimod is an immune response modifier.
Danish: Imiquimod er en immunreaktions-modifikator.
English: Saturable binding studies suggest a membrane receptor for imiquimod exists on responding immune cells.
Danish: Undersøgelser af mættede bindinger antyder, at der eksisterer en membranreceptor for imiquimod i reagerende immunceller.
English: Aldara cream may weaken condoms and diaphragms, therefore the cream should not be left on during sexual activity.
Danish: Aldara creme kan svække virkningen af kondomer og pessarer, og derfor bør cremen ikke blive siddende under seksuel aktivitet.
English: Minimal systemic absorption of imiquimod 5% cream across the skin of 58 patients with actinic keratosis was observed with 3 times per week dosing for 16 weeks.
Danish: En minimal systemisk absorption i huden af imiquimod 5% creme blev observeret hos 58 patienter med aktinisk keratose ved dosering 3 gange om ugen i 16 uger.
English: Whilst using Aldara cream and until healed, the treatment area is likely to appear noticeably different from normal skin.
Danish: Mens De bruger Aldara creme, og indtil ophelingen, vil behandlingsområdet sandsynligvis se markant anderledes ud end normal hud.
English: Some systemic adverse reactions, including headache (3.7%), influenza-like symptoms (1.1%), and myalgia (1.5%) were also reported.
Danish: Nogle systemiske bivirkninger, herunder hovedpine (3,7%), influenzalignende symptomer (1,1%) og myalgi (1,5%), blev også indberettet.
English: Very common effects include redness (61% patients), wearing away of the skin (30% patients), flakiness and swelling.
Danish: Meget Almindelige bivirkninger: rødme (61% af patienter), afskalning af huden (30% af patienter), skæl og hævelser.
English: Target tumours were histologically confirmed single primary superficial basal cell carcinomas with a minimum size of 0.5 cm and a maximum diameter of 2 cm. Tumours located within 1 cm of the eyes, nose, mouth, ears or hairline were excluded.
Danish: Måltumorerne var histologisk bekræftet som værende enkelte primære superficielle basalcellekarcinomer med en minimumstørrelse på 0,5 cm og en maksimumdiameter på 2 cm. Tumorer inden for 1 cm fra øjne, næse, mund, ører eller hårkant blev ikke inkluderet.
English: The risk of severe local skin reactions may be increased when imiquimod is used at higher than recommended doses (see section 4.2).
Danish: Risikoen for kraftige hudreaktioner kan stige, hvis imiquimod bruges i større doser end de anbefalede (se pkt.
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.
Danish: Sikkerhedsdata for anvendelse af cremen til mænd, der ikke er omskårede, som behandles med imiquimod creme tre gange om ugen og som udfører en daglig hygiejnerutine for forhuden, er begrænset til at omfatte mindre end 100 patienter.
English: The treatment frequency and duration differ for genital warts, basal cell carcinoma and actinic keratosis (see specific instructions for each indication).
Danish: Behandlingshyppigheden og -varigheden er forskellig for kønsvorter basalcellekræft og aktinisk keratose (se de specifikke instruktioner for den enkelte sygdom).
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.
Danish: Systemisk absorptionsdata viste at absorptionen af imiquimod efter topikal applikation på MC inficeret hud hos pædiatriske patienter mellem 6-12 år var lav i forhold til absorptionen hos raske voksne og voksne med aktinisk keratose eller superficielt basalcellekarcinom.
English: Reductions in haemoglobin, white blood cell count, absolute neutrophils and platelets have been observed in clinical trials.
Danish: Reduktioner i hæmoglobin, hvide blodlegemer samt absolutte neutrofiler og thrombocytter er observeret i kliniske studier.
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.
Danish: Et års data fra to sammenlignende studier viste en helingsfrekvens på 27% (35/128 patienter) hos de patienter, som blev klinsik frie for læsioner efter en eller to behandlingsperioder.
English: Increases in systemic levels of alpha interferon and other cytokines following topical application of imiquimod were demonstrated in a pharmacokinetic study.
Danish: Stigninger i de systemiske niveauer af alfa-interferon og andre cytokiner efter topisk anvendelse af imiquimod blev påvist i et farmakokinetisk studie.
English: Persistent dermal overdosing of imiquimod cream could result in severe local skin reactions.
Danish: Vedvarende dermal overdosering af imiquimod creme kan forårsage alvorlige lokale hudreaktioner.
English: Do not store above 25 C
Danish: Må ikke opbevares ved temperaturer over 25C.
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.
Danish: • Klinisk typiske, ikke-hyperkeratotiske, ikke-hypertrofiske aktiniske keratoser (AK´er) i ansigt eller hovedbund hos raske voksne patienter med normal immunstatus, når størrelsen af læsionerne eller antallet begrænser effekt og/eller mulig anvendelse af kryoterapi, og andre lokale behandlingsalternativer er kontraindicerede eller mindre velegnede.
English: If you have open sores: do not start using Aldara cream until after the sores have healed.
Danish: - Hvis De har åbne sår: De må ikke begynde at anvende Aldara creme, før sårene er helet.
English: Topical administration of imiquimod cream resulted in no tumour enhancement at any dose, in comparison with the vehicle cream group.
Danish: Topisk administration af imiquimod creme resulterede ikke i nogen øget forekomst af tumorer uanset dosis, sammenlignet med gruppen, der blev behandlet med vehikelcreme.
English: There was no evidence for serious adverse reaction caused by imiquimod in paediatric patients.
Danish: Der var ingen evidens for alvorlige bivirkninger forårsaget af imiquimod hos pædiatriske patienter.
English: Patients with reduced haematologic reserve have not been studied in clinical trials.
Danish: Patienter med reducerede hæmatologiske reserver er ikke blevet undersøgt i disse forsøg.
English: If you miss a dose, apply cream as soon as you remember and then continue in your regular schedule.
Danish: Hvis De springer en dosis over, skal De påføre cremen, så snart De kommer i tanker om det, og derefter fortsætte med Deres sædvanlige behandlingsplan.
English: Before going to bed, wash your hands and the treatment area with mild soap and water.
Danish: Før De går i seng, skal De vaske hænder og behandlingsområde med mild sæbe og vand.
English: • Do not use Aldara cream until the area to be treated has healed after previous drug or surgical treatment.
Danish: o Brug ikke Aldara creme, før det område, der skal behandles, er ophelet efter tidligere medicinsk eller kirurgisk behandling.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Aldara creme give bivirkninger, men ikke alle får bivirkninger.
English: If the lesions have not all disappeared, further four weeks of treatment may be necessary.
Danish: Hvis læsionerne ikke er helt væk, kan yderligere 4 ugers behandling være nødvendig.
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.
Danish: I de pivotale studier med dosering 3 gange ugentligt i op til 2 forløb på hver 4 uger indberettede 56% af patienterne, der fik imiquimod, mindst én bivirkning.
English: The results of 3 phase III pivotal efficacy studies showed that treatment with imiquimod for sixteen weeks was significantly more effective than treatment with vehicle as measured by total clearance of treated warts.
Danish: Resultater fra 3 fase III effekt studier viser, at 16 ugers behandling med imiquimod var signifikant mere effektivt end placebo målt som total clearance af vorter.
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).
Danish: To åbne, randomiserede, kontrollerede kliniske studier sammenlignede langtidsvirkninger af imiquimod med dem efter behandling med topikal diclofenac i patienter med aktinisk keratose med henblik på risikoen for udvikling til in situ eller invasiv planocellulær hudkræft (SCC).
English: Superficial basal cell carcinoma (5x/wk, 6 wks) N = 185
Danish: Superficielt basalcellekarcinom (5x ugtl/6 u) N = 185
English: Ear and labyrinth disorders: Tinnitus
Danish: Øre og labyrint Tinnitus
English: If any lesions persist, treatment should be repeated for another four weeks.
Danish: Hvis der stadig er læsioner i området, gentages behandlingen i endnu 4 uger.
English: Sufficient cream should be applied to cover the treatment area.
Danish: Tilstrækkelig creme skal påføres og dække det ønskede behandlingsområde.
English: These adverse events are considered at least possibly causally related to treatment with imiquimod.
Danish: Disse bivirkninger anses for i det mindste at være muligvis kausalt forbundne med behandlingen med imiquimod.
English: Imiquimod is not recommended for the treatment of AK lesions with marked hyperkeratosis or hypertrophy as seen in cutaneous horns.
Danish: Imiquimod anbefales ikke til behandling af AK-læsioner med udtalt hyperkeratose eller hypertrofi, som det ses i forbindelse med hudhorn.
English: Sachets should not be re-used once opened.
Danish: Et brev må ikke bruges igen, når det først er åbnet.
English: - Each box contains 12 or 24 single-use polyester/aluminium foil sachets.
Danish: Hver pakning indeholder 12 eller 24 engangsbreve af polyester/aluminiumsfolie.
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.
Danish: Da der ikke er observeret kvantificerbare niveauer (>5 ng/ml) i serum efter en enkelt eller flere doser, kan der ikke gives råd om anvendelse eller ikke anvendelse af imiquimod til ammende mødre.
English: Patients had clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions on the balding scalp or face within a contiguous 25 cm treatment area.
Danish: Patienterne havde klinisk typiske, synlige, adskilte, ikke-hyperkeratotiske, ikke-hypertrofiske AK-læsioner inden for et sammenhængende 25 cm stort behandlingsområde på en ikke behåret hovedbund eller i ansigtet.
English: Apply the cream to the affected area.
Danish: Påfør cremen på det angrebne område.
English: Do not breast-feed your infant during treatment with Aldara cream, as it is not known whether imiquimod is secreted in human milk.
Danish: De må ikke amme under behandling med Aldara creme, da det ikke vides, om imiquimod udskilles i modermælken.
English: EU/1/98/080/001 12 sachets EU/1/98/080/002 24 sachets
Danish: EU/1/98/080/001 (12 breve) EU/1/98/080/002 (24 breve)
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).
Danish: Disse vurderinger af kliniske tegn indikerer, at lokale hudreaktioner, herunder erytem (61%), erosion (30%), ekskoriation/afskalning/skældannelse (23%) og ødem (14%), var almindelige i disse placebokontrollerede kliniske forsøg, hvor imiquimod creme blev påført tre gange om ugen (se pkt.
English: Rare cases of remote site dermatologic drug reactions, including erythema multiforme, have been reported from clinical trials.
Danish: Sjældne tilfælde af dermatologiske lægemiddelraktioner på hunden uden for behandlingsområdet herunder erythema multiforme, er rapporteret fra kliniske studier.
English: The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 4-8 weeks after the end of treatment.
Danish: Det kliniske udfald af behandlingen kan fastlægges efter regenerationen af det behandlede hudområde cirka 4-8 uger efter behandlingens ophør.
English: • External genital and perianal warts (condylomata acuminata) in adults.
Danish: • Udvendige vorter ved kønsorganer og endetarmsåbning (Condyloma acuminata) hos voksne
English: It usually occurs in middle-aged and elderly people, especially those who are fair-skinned and is caused by too much sun exposure.
Danish: Det opstår oftest hos midaldrende og ældre personer, især hos personer med lys hud.
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.
Danish: 4.5), Hos disse patienter skal værdien af imiquimod behandlingen afvejes overfor risikoen forbundet med en mulig forværring af deres autoimmune sygdom.
English: The efficacy of imiquimod 5 times per week for 6 weeks was studied in two double-blind vehicle controlled clinical trials.
Danish: Effekten af imiquimod 5 gange om ugen i 6 uger blev undersøgt i to dobbeltblindede, kliniske studier med vehikel som kontrol.
English: Some systemic adverse reactions, including myalgia (2%) were reported by imiquimod treated patients.
Danish: Nogle systemiske bivirkninger, herunder myalgi (2%), blev indberettet af patienter, der blev behandlet med imiquimod.
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.
Danish: De maksimale serumkoncentrationer af præparatet i slutningen af uge 16 blev observeret efter mellem 9 og 12 timer og var 0,1; 0,2 og 1,6 ng/ml for påføringer henholdsvis i ansigt (12,5 mg, 1 engangsbrev), hovedbund (25 mg, 2 breve) og på hænder/arme (75 mg, 6 breve).
English: Local skin reactions such as erythema, erosion, excoriation, flaking and oedema are common.
Danish: Lokale hudreaktioner, som f.eks. erythema, erosion, ekskoriation/afskalning og ødemer, er almindelige.