FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited experience in the use of imiquimod cream in the treatment of men with foreskinassociated warts.
Danish: Der er begrænset erfaring vedrørende brugen af imiquimod creme ved behandling af mænd med forhudsforbundne vorter.
English: The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours.
Danish: Cremen skal påføres inden normal sengetid og blive siddende på huden i cirka 8 timer.
English: • If you are being treated for basal cell carcinoma or actinic keratosis follow these additional precautions:
Danish: ● Hvis De behandles for basalcellekræft eller aktinisk keratose, skal De følge disse ekstra forsigtighedsregler:
English: Boxes of 12 or 24 single-use polyester/aluminium foil sachets, containing 250 mg of cream.
Danish: Æsker med 12 eller 24 engangsbreve af polyester/aluminium folie indeholdende 250 mg creme.
English: After a 4-week treatment-free period, clearance of AKs should be assessed.
Danish: Efter en behandlingsfri periode på 4 uger, bør lægen tilse og vurdere AK-læsionerne.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity and teratogenicity.
Danish: Ikke-kliniske sikkerhedsdata viser ingen særlig risiko for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinog virkning og reproduktionstoksicitet.
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.
Danish: Disse vurderinger af de kliniske tegn viser, at svært erytem (31%), kraftige erosioner (13%) og kraftig skorpedannelse (19%) var meget almindeligt i disse forsøg med imiquimod creme påført 5 gange om ugen.
English: When applied topically, systemic overdosage with imiquimod cream is unlikely due to minimal percutaneous absorption.
Danish: Ved lokal anvendelse er systemisk overdosering med imiquimod creme usandsynlig på grund af den minimale perkutane absorption.
English: b) Tabular Listing of adverse events:
Danish: b) Tabelliste over bivirkninger:
English: 12 sachets.
Danish: 12 engangsbreve.
English: If you experience skin lesions or spots on your skin that start out as small red areas and progress to look like mini targets, possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores, stop using Aldara cream and tell your doctor immediately.
Danish: Hvis De får sår eller pletter på huden, som begynder som små røde områder og udvikles til små cirkler, sandsynligvis med følgende symptomer som kløe, feber, ubehag, ømme led, problemer med synet, brændende, ømme eller kløende øjne og mund, skal De stoppe behandlingen med Aldara øjeblikkeligt og informere Deres læge.
English: Most skin reactions were mild to moderate in severity and resolved within 2 weeks of treatment discontinuation.
Danish: De fleste hudreaktioner var milde til moderate i sværhedsgrad og forsvandt inden for 2 uger efter seponering af behandlingen.
English: Apply a thin layer of Aldara cream onto clean, dry wart area and rub gently into the skin until cream vanishes.
Danish: Kom et tyndt lag Aldara creme på det rene, tørre område med vorter og gnid cremen forsigtigt ind i huden, indtil den er smurt ind.
English: ● If you are being treated for actinic keratosis
Danish: ● Hvis De behandles for aktinisk keratose
English: Should an intolerable skin reaction occur, the cream should be removed by washing the area with mild soap and water.
Danish: Hvis en uudholdelig hudreaktion opstår, skal cremen fjernes ved at vaske området med en mild sæbe og vand.
English: During therapy and until healed, affected skin is likely to appear noticeably different from normal skin.
Danish: Under behandling og indtil opheling vil den angrebne hud sandsynligvis synes markant anderledes end normal hud.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: Imiquimod has not been evaluated for the treatment of basal cell carcinoma within 1 cm of the eyelids, nose, lips or hairline.
Danish: Imiquimod er ikke blevet evalueret til behandling af basalcellekarcinomer inden for 1 cm fra øjenlåg, næse, læber eller hårkant.
English: In trials with 5 times per week dosing 58% of patients experienced at least one adverse event.
Danish: I et studie med dosering 5 gange om ugen oplevede 58% af patienterne mindst én bivirkning.
English: Local skin reactions, such as erythema, are probably an extension of the pharmacologic effects of imiquimod cream.
Danish: Lokale hudreaktioner, såsom erytem, er sandsynligvis en udvidelse af de farmakologiske effekter af imiquimod creme.
English: In those imiquimod patients who achieved total clearance of their warts, the median time to clearance was 8 weeks.
Danish: Hos patienter som opnåede total clearance var median tiden til clearance 8 uger.
English: ALDARA 5% cream
Danish: Aldara 5% creme
English: Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday, and Friday; or Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for 6 to 10 hours.
Danish: Imiquimod creme skal anvendes 3 gange om ugen (for eksempel: mandag, onsdag og fredag, eller tirsdag, torsdag og lørdag) inden den normale sengetid og bør blive siddende på huden i 6 til 10 timer.
English: Blood and lymphatic system disorders:
Danish: Blod og lymfesystem Lymfadenopati
English: Imiquimod cream therapy is not recommended until the skin has healed after any previous drug or surgical treatment.
Danish: Anvendelse af imiquimod creme anbefales derfor ikke, før huden er helet efter tidligere medicinsk eller kirurgisk behandling.
English: e) Paediatric population:
Danish: e) Pædiatrisk population
English: External genital warts in adults:
Danish: Udvendige genitale vorter hos voksne:
English: Do not cover the treated area with bandages or other dressings after you have applied Aldara cream.
Danish: Dæk ikke det behandlede område med forbinding eller plaster efter at De har påført Aldara creme.
English: The induction of alpha interferon and other cytokines following imiquimod cream application to genital wart tissue has also been demonstrated in clinical studies.
Danish: Induktion af alfainterferon og andre cytokiner efter påføring af imiquimod creme på genitalt vortevæv er også blevet påvist i kliniske undersøgelser.
English: Apply Aldara cream to the affected area and 1cm (approx. 0.5 inch) around the affected area.
Danish: Påfør Aldara cremen på det angrebne område og 1 cm omkring det angrebne område.
English: 24 sachets.
Danish: 24 engangsbreve.
English: The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 12 weeks after the end of treatment.
Danish: Det kliniske resultat af behandlingen kan fastlægges efter den behandlede huds regeneration cirka 12 uger efter behandlingen er afsluttet.
English: Contents of the pack and other information
Danish: Pakningsstørrelser og yderlige oplysninger
English: Superficial basal cell carcinoma:
Danish: Superficielt basalcellekarcinom:
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.
Danish: Data vedrørende anvendelse af imiquimod til behandling af aktiniske keratoser på andre anatomiske steder, end ansigt og hovedbund, er meget begrænsede.
English: Many of the undesirable effects of Aldara cream are due to its local action on your skin.
Danish: Mange af bivirkningerne fra Aldara creme skyldes den lokale virkning på huden.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om Aldara på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Local skin reactions are common but these reactions generally decrease in intensity during therapy or resolve after cessation of imiquimod cream therapy.
Danish: Lokale hudreaktioner er almindelige, men disse reaktioner reduceres generelt i styrke under behandling eller svinder efter seponering af behandlingen med imiquimod creme.
English: The most frequently reported adverse event from these trials judged probably or possibly related to imiquimod cream was application site reactions (22% of imiquimod treated patients).
Danish: Den hyppigst indberettede bivirkning fra disse studier, der blev vurderet til sandsynligvis eller muligvis at være forbundet med imiquimod creme, var reaktioner på indgivelsesstedet (22% af de patienter, der blev behandlet med imiquimod).
English: Early signs of stricture may include local skin reactions (e.g. erosion, ulceration, oedema, induration), or increasing difficulty in retracting the foreskin.
Danish: Tidlige tegn på forsnævring kan være lokale hudreaktioner (f.eks. erosion, sårdannelse, ødemer, forhærdning) eller øget besvær med at trække forhuden tilbage.
English: If you forget to use Aldara cream
Danish: Hvis De har glemt at bruge Aldara creme
English: In the pivotal trials with 3 times a week dosing, the most frequently reported adverse drug reactions judged to be probably or possibly related to imiquimod cream treatment were application site reactions at the wart treatment site (33.7% of imiquimod treated patients).
Danish: I de pivotale studier med dosering 3 gange om ugen var de hyppigst indberettede bivirkninger, der blev vurderet til sandsynligvis eller muligvis at være forbundet med behandlingen med Imiquimod creme, reaktioner på påføringsstedet (33,7% af de patienter, der blev behandlet med imiquimod).
English: • Do not apply the cream internally.
Danish: o Cremen må ikke påføres indvendigt.
English: For those patients with complete clinical clearance of the treated AK field recurrence of AK lesions was evaluated.
Danish: Recidiv for patienter med fuldstændig klinisk opheling på det behandlede AK-område blev evalueret.
English: Hands should be washed carefully before and after application of cream.
Danish: Hænderne skal vaskes omhyggeligt før og efter påføring af creme.
English: 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%).
Danish: I kliniske studier med imiquimod creme 3 gange ugentligt i op til 4 eller 8 uger, var de hyppigeste bivirkninger på påføringsstedet kløe (14%) og varme (5%).
English: No clinical experience exists with the use of imiquimod cream in immunocompromised patients.
Danish: Der findes ingen klinisk erfaring med anvendelse af imiquimod creme til immunsvækkede patienter.
English: An interruption of dosing should be considered.
Danish: I disse tilfælde bør det overvejes at holde pause med behandlingen.
English: Fungal infection
Danish: Fungusinfektion
English: Application to broken skin could result in increased systemic absorption of imiquimod leading to a greater risk of adverse events (refer to section 4.8 and 4.9)
Danish: Påføring på ødelagt hud kan resultere i øget systemisk absorption af imiquimod, hvilket fører til en øget risiko for bivirkninger (se pkt.
English: Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5 %).
Danish: Hvert brev indeholder 12,5 mg imiquimod i 250 mg creme (5%).
English: No clinical experience exists with imiquimod cream immediately following treatment with other cutaneously applied drugs for treatment of external genital or perianal warts.
Danish: Der findes ingen klinisk erfaring med anvendelse af imiquimod creme umiddelbart efter behandling med andre kutant anvendte lægemidler til behandling af vorter ved kønsorganer og endetarmsåbning.
English: Imiquimod cream may weaken condoms and diaphragms, therefore concurrent use with imiquimod cream is not recommended.
Danish: Imiquimod creme kan svække virkningen af kondomer og pessarer - samtidig brug af Imiquimod creme anbefales derfor ikke.
English: After this period it is essential that imiquimod cream is removed with mild soap and water.
Danish: Efter denne periode er det vigtigt, at imiquimod creme fjernes med en mild sæbe og vand.
English: External genital warts:
Danish: Udvendige genitale vorter:
English: Superficial basal cell carcinoma in adults:
Danish: Superficielt basalcellekarcinom hos voksne:
English: Skin infections during treatment with imiquimod have been observed.
Danish: Hudinfektioner under behandling med imiquimod er observeret.
English: (3x/wk, 4 or 8 wks) N = 252
Danish: Aktinisk keratose (3x ugtl/4 eller 8 u) N = 252
English: After 6 to 10 hours wash the area where Aldara cream was applied with mild soap and water.
Danish: Vask efter 6 til 10 timer det område, hvor cremen blev påført, med mild sæbe og vand.
English: Men with warts under the foreskin should pull the foreskin back each day and wash underneath it.
Danish: - Mænd med vorter under forhuden, bør trække forhuden tilbage hver dag og vaske området.
English: Before applying imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly.
Danish: Inden påføring af imiquimod creme skal patienten vaske behandlingsområdet med mild sæbe og vand og tørre området grundigt.
English: Methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed).
Danish: Methylparahydroxybenzoat (E218) og propylparahydroxybenzoat (E216) kan forårsage allergiske reaktioner (muligvis forsinkede).
English: - Each Aldara 5% cream sachet contains 250 mg of a white to slightly yellow cream.
Danish: Hvert brev med Aldara 5% creme indeholder 250 mg hvid til let gullig creme.
English: Use in children and adolescents is not recommended.
Danish: Børn og unge Anvendelse til børn og unge anbefales ikke.
English: In immunocompromised patients, repeat treatment with imiquimod cream is not recommended.
Danish: Hos immunkompromitterede patienter anbefales det ikke at behandlingen gentages.
English: Some systemic adverse reactions, including back pain (1.1%) and influenza-like symptoms (0.5%) were reported by imiquimod cream patients.
Danish: Nogle systemiske bivirkninger, herunder rygsmerter (1,1%) og influenzalignende symptomer (0,5%), blev indberettet af de patienter, der var behandlet med imiquimod creme.
English: Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod cream use.
Danish: Lokaliseret hypopigmentering og hyperpigmentering efter anvendelse af imiquimod creme er rapporteret isoleret.
English: One sachet contains enough cream to cover an area of 25 cm
Danish: Ét brev indeholder tilstrækkelig creme til at dække et område på 25 cm2.
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.
Danish: I et fire måneders dermalt toksicitetsforsøg med rotter blev der observeret en betydelig nedgang i kropsvægt og en stigning i miltvægt ved 0,5 og 2,5 mg/kg.
English: Patient reported adverse reactions from 2292 patients treated with imiquimod cream in placebo controlled and open clinical studies are presented below.
Danish: Indberettede bivirkninger fra 2.292 patienter, der blev behandlet med Imiquimod creme i placebokontrollerede og åbne kliniske studier, vises i nedenstående.
English: The cream should be rubbed into the treatment area until the cream vanishes.
Danish: Cremen skal gnides ind i behandlingsområdet, indtil cremen ikke er synlig.
English: 100 mg of cream contains 5 mg of imiquimod.
Danish: 100 mg creme indeholder 5 mg imiquimod.
English: Infections and infestations: Infection
Danish: Infektioner og parasitære sygdomme Infektion
English: Methyl hydroxybenzoate (E 218) 2.0 mg/g cream Propyl hydroxybenzoate (E 216) 0.2 mg/g cream Cetyl alcohol 22.0 mg/g cream Stearyl alcohol 31.0 mg/g cream Benzyl alcohol 20.0 mg/g cream
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: methylparahydroxybenzoat (E218) 2,0 mg/g creme propylparahydroxybenzoat (E216) 0,2 mg/g creme cetylalkohol 22,0 mg/g creme stearylalkohol 31,0 mg/g creme benzylalkohol 20,0 mg/g creme
English: Psychiatric disorders: Insomnia
Danish: Psykiske forstyrrelser Insomni
English: You must tell your doctor if you are pregnant or intend to become pregnant.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds.
English: For imiquimod no clinical data on exposed pregnancies are available.
Danish: Der foreligger ikke kliniske data om eksponering for imiquimod under graviditet.
English: • Actinic keratosis
Danish: ●Aktinisk keratose
English: Apart from reactions in the skin, other common effects include headache, anorexia, nausea, muscle pain, joint pain and tiredness.
Danish: Andre almindelige bivirkninger, udover reaktionerne på huden, er hovedpine, anoreksi, kvalme, muskelsmerter, ledsmerter og træthed.
English: Investigators of the placebo controlled clinical trials were required to evaluate protocol mandated clinical signs (skin reactions).
Danish: Investigatorer i de placebokontrollerede kliniske studier skulle evaluere kliniske tegn (hudreaktioner) i henhold til protokollen.
English: Skin and subcutaneous tissue disorders:
Danish: Hud og subkutane væv Pruritus
English: Cream
Danish: Creme
English: Men with warts under the foreskin should pull the foreskin back each day and wash underneath it (see section 2 “Warnings and precautions”)
Danish: Mænd med vorter under forhuden bør trække forhuden tilbage hver dag og vaske området (se afsnit.
English: Each sachet contains 250 mg cream (100 mg cream contains 5 mg imiquimod).
Danish: Hvert brev indeholder 250 mg creme (100 mg creme indeholder 5 mg imiquimod).
English: The use of an occlusive dressing is not recommended with imiquimod cream therapy.
Danish: Anvendelse af en okklusionsbandage anbefales ikke ved behandling med imiquimod creme.
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.
Danish: 4.4), hvis en lokal hudreaktion på imiquimod cremen er meget ubehagelig for patienten, eller hvis der er infektion på behandlingsstedet.
English: Commonly some patients (4% or less) have experienced headache, uncommonly fevers and flu like symptoms joint and muscle pains; prolapse of the womb; pain on intercourse in females; erection difficulties; increase in sweating; feeling sick; stomach and bowel symptoms; ringing in the ears; flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; loss of appetite; swollen glands; bacterial, viral and fungal infections (e.g. cold sores); vaginal infection including thrush; cough and colds with sore throat.
Danish: Almindelige bivirkninger: hovedpine (4% eller færre patienter) , ualmindelig feber og influenzalignende symptomer, samt led- og muskelsmerter, fremfald af uterus, smerter ved samleje (kvinder), erektionsbesvær, øget svedtendens, kvalme, føle sig dårlig, symptomer i mave og tarm, ringen for ørene, rødmen, træthed, svimmelhed, migræne, snurren og prikken, søvnløshed, depression, manglende appetit, hævede kirtler, bakterie-, virus- og svampeinfektioner (f.eks. forkølelsessår),infektion i vagina (herunder svampeinfektion); hoste og forkølelse med ondt i halsen.
English: Investigators of placebo controlled trials were required to evaluate protocol mandated clinical signs (skin reactions).
Danish: Investigatorer i placebokontrollerede studier skulle evaluere kliniske tegn (hudreaktioner) i henhold til protokollen.
English: Other local reactions such as induration, ulceration, scabbing, and vesicles have also been reported.
Danish: Der er også rapporteret om andre lokale reaktioner, som f.eks. induration, sårdannelse, skorpedannelse og blærer.
English: External genital warts, superficial basal cell carcinoma and actinic keratosis:
Danish: Udvendige genitale vorter, superficielt basalcellekarcinom og aktinisk keratose:
English: ● If you are being treated for basal cell carcinoma:
Danish: ● Hvis De behandles for basalcellekræft:
English: The most frequently reported adverse events from the trials judged probably or possibly related to imiquimod cream are application site disorders, with a frequency of 28.1%.
Danish: I studiet var de hyppigst indberettede bivirkninger, som blev vurderet til sandsynligvis eller muligvis at være forbundet med imiquimod creme, reaktioner på påføringsstedet med en hyppighed på 28,1%.
English: If the treated AK field was not completely cleared of lesions, additional treatment cycles could be started.
Danish: Hvis læsionerne ikke forsvandt på det behandlede AKområde, kunne yderligere behandlinger påbegyndes.
English: A total of 126 of 242 patients treated with imiquimod (52.1%) and 84 of 237 patients treated with topical diclofenac (35.4%) showed complete clinical clearance of the treated AK field at week 20 (i.e. about 8 weeks after the end of the initial treatment cycle); a difference of 16.6% (95% CI: 7.7% to 25.1%).
Danish: Samlet udviste 126 af 242 patienter i behandling med imiquimod (52,1 %) og 84 af 237 patienter i behandling med topikal diclofenac (35,4 %) fuldstændig opheling på det behandlede AK-område i uge 20 (dvs. omkring 8 uger efter den første behandlingsrunde); en forskel på 16,6 % (95 % CI: 7,7 til 25,1 %).
English: In 157 imiquimod-treated male patients, the combined total clearance rate was 23% as compared to 5% in 161 vehicle-treated patients (95%CI for rate difference: 3% to 36%, p<0.001).
Danish: Hos 157 imiquimod behandlede mænd, var frekvensen 23% sammenlignet med 5% hos 161 placebobehandlede (95% CI for forskellen: 3% til 36% p<0,001).
English: Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol
Danish: Aldara creme indeholder methylparahydroxybenzoat, propylparahydroxybenzoat, cetylalkohol, stearylalkohol og benzylalkohol.
English: In the event of accidental contact, remove cream by rinsing with water.
Danish: Hvis dette sker ved et uheld skal cremen fjernes med vand.
English: Four weeks after finishing this first treatment, your doctor will assess your skin.
Danish: Deres læge vil vurdere Deres hud 4 uger efter, at denne første behandling er afsluttet.
English: Application site inflammation
Danish: Inflammation på påføringsstedet
English: The excipients methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed).
Danish: Hjælpestofferne methylparahydroxybenzoat (E218) og propylparahydroxybenzoat (E216),kan forårsage allergiske reaktioner (muligvis forsinket).
English: What you need to know before you use Aldara cream
Danish: Det skal De vide, før De begynder at bruge Aldara creme
English: After about 8 hours, wash the area where Aldara cream was applied with mild soap and water.
Danish: Vask efter cirka 8 timer det område, hvor cremen blev påført, med mild sæbe og vand.
English: Discard any cream remaining in a sachet after use.
Danish: Kassér eventuel creme, der er tilbage i brevet efter brug.
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.
Danish: 4.5) Hos disse patienter skal værdien af imiquimod behandlingen afvejes overfor risikoen forbundet med en mulig immunologisk afstødningsreaktion rettet mod transplantatet eller graft-versus-host sygdom.
English: Imiquimod has the potential to exacerbate inflammatory conditions of the skin.
Danish: Imiquimod creme kan forværre betændelsestilstande i huden.
English: Aldara 5% cream imiquimod
Danish: Aldara 5% creme imiquimod
English: Each containing 250 mg of cream.
Danish: Hvert brev indeholder 250 mg creme.