FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have previously used this medicine or other similar preparations in a different concentration.
Danish: • hvis du tidligere har brugt dette lægemiddel eller andre lignende lægemidler i en anden koncentration.
English: System organ class
Danish: System organklasser
English: There is also a possibility that existing inflammation may temporarily worsen.
Danish: Der er også en mulighed for, at eksisterende betændelse midlertidigt kan forværres.
English: • if you have an abnormal blood count.
Danish: • hvis du har et unormalt blodtal.
English: Always use this medicine exactly as your doctor has told you.
Danish: Brug altid dette lægemiddel nøjagtigt som lægen har fortalt dig.
English: Very rare (<1/10,000) and not known (cannot be estimated from the available data)
Danish: Meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: Many of the side effects of this medicine are due to its local action on your skin.
Danish: Mange af bivirkningerne ved denne medicin skyldes dets lokale indvirkning på din hud.
English: Management of overdose should consist of treatment of clinical symptoms.
Danish: Håndtering af overdosering bør omfatte behandling af kliniske symptomer.
English: Mice were maintained for an additional 12 weeks.
Danish: Musene blev yderligere opretholdt i 12 uger.
English: If you go outside during the day use sunscreen and wear protective clothing and a wide-brimmed hat.
Danish: Hvis du går udenfor i løbet af dagen, skal du anvende solcreme og bære beskyttende tøj og en hat med bred skygge.
English: Do not use this medicine until your doctor has shown you the right way to use it.
Danish: Brug ikke denne medicin før din læge har vist dig den rigtige måde at anvende den på.
English: Follow-up information suggests that these skin colour changes may be permanent in some patients.
Danish: Opfølgende oplysninger tyder på, at disse hudfarve ændringer kan være permanente hos nogle patienter.
English: While these changes have tended to improve with time, in some patients they may be permanent.
Danish: Disse ændringer har en tendens til at forbedre sig med tiden, men kan hos nogle patienter være permanente.
English: These patients should be monitored under the close supervision of an experienced physician.
Danish: Disse patienter bør monitoreres under nøje opsyn af en erfaren læge.
English: It is the lead compound of the imidazoline family.
Danish: Det er den ledende forbindelse i imidazolin-familien.
English: These areas can be the same colour as your skin or are greyish, pink, red or brown.
Danish: Disse områder kan være den samme farve som din hud eller grålige, rosa, røde eller brune.
English: Systemic reactions
Danish: Systemiske reaktioner
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Denne medicin kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Furthermore, tumours were not seen at any site in a 2-year oral carcinogenicity study in rats.
Danish: Endvidere blev tumorer ikke set noget sted i et 2-årigt oral karcinogenicitetsstudie på rotter.
English: Studies in animals do not indicate direct or indirect harmful effects in pregnancy.
Danish: Dyrestudier indikerer ikke direkte eller indirekte skadelige virkninger under graviditet.
English: • Only use the cream externally (on the skin of face or scalp).
Danish: • Anvend kun cremen udvendigt (på ansigtshuden eller på hovedbunden).
English: • if you have problems with your immune system or if you take medicine to suppress your immune system (e.g. after an organ transplant).
Danish: • hvis du har problemer med dit immunsystem eller du tager medicin for at undertrykke dit immunsystem (f.eks. efter en organtransplantation).
English: No overall differences in safety or effectiveness were observed between patients 65 years or older and the younger patients.
Danish: Der blev ikke observeret generelle forskelle i sikkerhed eller effekt mellem patienter på 65 år eller ældre og yngre patienter.
English: 61352 Bad Homburg Germany
Danish: 61352 Bad Homburg Tyskland
English: • Do not use more cream than your doctor has advised.
Danish: • Bug ikke mere creme end din læge har rådet dig til.
English: Hands should be washed carefully before and after application of cream.
Danish: Hænderne skal vaskes grundigt før og efter påføring af cremen.
English: This medicine should not be given to children below the age of 18 years because the safety and efficacy in patients below the age of 18 years have not been established.
Danish: Denne medicin bør ikke gives til børn under 18 år, da sikkerhed og effekt hos patienter under 18 år ikke er blevet undersøgt.
English: White to faintly yellow cream with a uniform appearance.
Danish: Hvid til svag gul creme med et ensartet udseende.
English: Study treatments were given as officially recommended.
Danish: Behandlingerne i studiet blev givet, som officielt anbefalet.
English: Meda AB Pipers väg 2A 170 73 Solna Sweden
Danish: Meda AB Pipers väg 2A 170 73 Solna Sverige
English: Benzyl alcohol may cause allergic reactions and mild local irritation.
Danish: Benzylalkohol kan medføre allergiske reaktioner og mild lokal irritation.
English: These reactions can be a sign that the medicine is working as intended.
Danish: Disse reaktioner kan være et tegn på, at medicinen virker efter hensigten.
English: A 18-month mouse carcinogenicity study by dermal administration on three days a week did not induce tumours at the application site.
Danish: Et 18-måneders carcinogenicitetsstudie på mus ved dermal administration i tre dage om ugen inducerede ikke tumorer på applikationsstedet.
English: Exacerbation of autoimmune conditions
Danish: Forværring af autoimmune tilstande
English: There is an association between the complete clearance rate and the intensity of local skin reactions (e.g. erythema).
Danish: Der er en sammenhæng mellem fuldstændig clearance rate og intensiteten af lokale hudreaktioner (f.eks. erythem).
English: This medicine stimulates your body's own immune system to produce natural substances which help fight your actinic keratosis.
Danish: Medicinen stimulerer din krops eget immunsystem til at producere naturlige stoffer, som hjælper med at bekæmpe aktinisk keratose.
English: Furthermore, imiquimod has the potential to exacerbate inflammatory conditions of the skin.
Danish: Endvidere har imiquimod potentialet til at forværre inflammatoriske tilstande i huden.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity and teratogenicity.
Danish: Ikke-kliniske data viser ingen særlig risiko for mennesker baseret på konventionelle undersøgelser af sikkerhedsfarmakologi, mutagenicitet og teratogenicitet.
English: Biotransformation Orally administered imiquimod is rapidly and extensively metabolised into two main metabolites.
Danish: Biotransformation Oralt administreret imiquimod er hurtigt og i udstrakt grad metaboliseret til to hovedmetabolitter.
English: In some individuals a lowering of blood counts was noted (frequency not known).
Danish: Hos enkelte personer har man konstateret en sænkning af blodtallet (hyppighed ikke kendt).
English: These local skin reactions may be related to the stimulation of local immune response.
Danish: Disse lokale hudreaktioner kan være relateret til stimulering af det lokale immunrespons.
English: Zyclara is for external use only.
Danish: Zyclara er kun til udvortes brug.
English: • Do not use sunlamps or tanning-beds, and avoid exposure to sunlight as much as possible during treatment with this medicine.
Danish: • Brug ikke højfjeldssol eller solarium og undgå udsættelse for sollys, så meget som muligt, under behandlingen med denne medicin.
English: The skin surface area treated should be protected from solar exposure.
Danish: Det behandlede område på hudens overflade bør beskyttes mod udsættelse for sol.
English: This medicine contains 5 mg benzyl alcohol in each sachet.
Danish: Denne medicin indeholder 5 mg benzylalkohol i hver brev.
English: Wash hands well with soap and water.
Danish: Vask hænderne godt med sæbe og vand.
English: These reductions are not considered to be clinically significant in patients with normal haematologic reserve.
Danish: Disse reduktioner anses ikke for at være klinisk signifikante hos patienter med normal hæmatologisk reserve.
English: While using Zyclara, you may experience local skin reactions because of the way it acts on your skin.
Danish: Mens du bruger Zyclara, kan du opleve lokale hudreaktioner på grund af den måde, det virker på din hud.
English: This medicine may reveal and treat actinic keratosis that have not be seen or felt before, and these may later go away.
Danish: Denne medicin kan afsløre og behandle aktiniske keratoser, der ikke tidligere har været set eller mærket, og disse kan senere gå væk.
English: Saturable binding studies suggest membrane receptors for imiquimod exists on responding cells; these are called toll-like receptor 7 and 8.
Danish: Undersøgelser på mættede bindinger tyder på at membranreceptorer for imiquimod findes på responderende celler; Disse kaldes Toll-like receptorer 7 og 8.
English: Reductions in haematological parameters requiring clinical intervention have been reported from postmarketing experience.
Danish: Reduktioner i hæmatologiske parametre, der kræver klinisk intervention, er blevet rapporteret efter markedsføring.
English: White soft paraffin Polysorbate 60
Danish: Hvid blød paraffin Polysorbat 60
English: Patients should continue treatment as prescribed.
Danish: Patienterne bør fortsætte behandlingen som foreskrevet.
English: Local dermal irritation, especially at higher doses, was observed in both species.
Danish: Hos begge arter blev der, især ved højere doser, observeret lokal hudirritation.
English: There are no data available of the use of imiquimod in children and adolescents.
Danish: Der er ingen tilgængelige data vedrørende brug af imiquimod til børn og unge.
English: Only in female mice, the incidences of hepatocellular adenomas were slightly greater than those for controls.
Danish: Kun i hunmus var forekomsten af hepatocellulære adenomer lidt større end for kontrollen.
English: Animals were administered imiquimod cream three times per week and were irradiated 5 days per week for 40 weeks.
Danish: Imiquimod creme blev administreret til dyrene tre gange om ugen, og dyrene blev bestrålet 5 dage om ugen i 40 uger.
English: The incidence corresponds well with the spectrum of spontaneous tumours, as is known in mice in correspondence with their age.
Danish: Forekomsten svarer godt til spektret af spontane tumorer, som det er kendt i mus i overensstemmelse med deres alder.
English: Cream.
Danish: Creme.
English: Caution should be exercised when prescribing Zyclara to pregnant women.
Danish: Der bør udvises forsigtighed ved ordinering af Zyclara til gravide kvinder.
English: While serious sequelae have not resulted, the possibility of infection in broken skin should always be considered.
Danish: Selvom disse ikke har resulteret i alvorlige følger, skal muligheden for infektioner i ødelagt hud altid overvejes.
English: Then contact your doctor or pharmacist.
Danish: Kontakt derefter din læge eller apoteket.
English: Zyclara 3.75% cream contains the active substance imiquimod, which is an Immune Response Modifier (to stimulate the human immune system).
Danish: Zyclara 3,75 % creme indeholder det aktive stof imiquimod, som er en immunrespons modifikator (til at stimulere det humane immunsystem).
English: Patients had 5-20 typical visible or palpable AK lesions in an area that exceeded 25 cm2 on either the face or balding scalp.
Danish: Patienterne havde typisk 5-20 synlige eller palpable AK-læsioner i et område, der oversteg 25 cm2 i enten ansigt eller den skaldede hovedbund.
English: If there is pus or another sign of skin infection (frequency not known), discuss this with your doctor.
Danish: Hvis der er pus eller andre tegn på hudinfektion (hyppighed ikke kendt), skal du tale med din læge om det.
English: The cream should not be applied more than once daily.
Danish: Cremen bør ikke anvendes mere end én gang dagligt.
English: If you notice any of these symptoms, tell your doctor.
Danish: Hvis du bemærker nogle af disse symptomer, skal du fortælle det til din læge.
English: Open a new sachet of Zyclara just before use and squeeze some cream onto your fingertip.
Danish: Åben et nyt brev af Zyclara lige før brug og klem noget creme ud på din fingerspids.
English: Your doctor will discuss the risks and benefits of using Zyclara during pregnancy.
Danish: Din læge vil fortælle om fordele og risici ved at bruge Zyclara under graviditet.
English: Increases in systemic levels of alpha interferon and other cytokines following topical application of imiquimod were also observed in human data.
Danish: Stigninger i de systemiske niveauer af alfa-interferon og andre cytokiner efter topikal anvendelse af imiquimod blev også observeret i humane data.
English: Systemic exposure (percutaneous penetration) was calculated from recovery of carbon-14 from [14C] imiquimod in urine and faeces.
Danish: Systemisk eksponering (perkutan penetration) blev beregnet fra genvinding af kulstof-14 fra [14C] imiquimod i urin og fæces.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du bruger dette lægemiddel.
English: An interruption of dosing or dose adjustment should be considered (see section 4.8).
Danish: En afbrydelse i doseringen eller dosisjustering bør overvejes (se pkt.
English: Date of first authorisation: 23/08/2012 Date of latest renewal: 22/03/2017
Danish: Dato for første markedsføringstilladelse: 23.08.2012 Dato for seneste fornyelse: 22.03.2017
English: Do not shower or bathe the area during this time.
Danish: Tag ikke brusebad eller karbad i løbet af denne tid.
English: The panel of induced cytokines varies with the cell's tissue origin.
Danish: Panelet af inducerede cytokiner varierer med cellens vævsoprindelse.
English: 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.
Danish: Da imiquimod har lav systemisk absorption fra human hud, og er ikke mutagent, er risikoen for mennesker fra systemisk eksponering sandsynligvis lav.
English: Use in immunocompromised patients and/or in patients with autoimmune conditions The safety and efficacy of Zyclara in immunocompromised patients (e.g. organ transplant patients) and/or patients with autoimmune conditions have not been established.
Danish: Anvendelse til immunkompromitterede patienter og/eller patienter med autoimmune sygdomme Sikkerheden og effekten af Zyclara i immunkompromitterede patienter (f.eks. organtransplanterede patienter) og/eller patienter med autoimmune sygdomme er ikke fastlagt.
English: The following side effects with imiquimod were reported:
Danish: Følgende bivirkninger er rapporteret med imiquimod:
English: Leave Zyclara on the skin for about 8 hours.
Danish: Lad Zyclara sidde på huden i ca. 8 timer.
English: Loughborough Leicestershire LE11 5SF, United Kingdom
Danish: Loughborough Leicestershire LE11 5SF, Storbritannien
English: This medicine should only be used for actinic keratosis on the face or scalp if your doctor has decided that it is the most appropriate treatment for you.
Danish: Denne medicin bør kun bruges til aktiniske keratoser i ansigtet eller hovedbunden, hvis din læge har besluttet, at det er den mest hensigtsmæssige behandling til dig.
English: This leaflet was last revised in (MM/YYYY).
Danish: Denne indlægsseddel blev senest ændret (MM/YYYY)
English: It is unknown whether imiquimod/metabolites are excreted in human milk.
Danish: Det er ukendt, om imiquimod/metabolitter udskilles i human mælk.
English: Zyclara should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Danish: Zyclara skal kun anvendes under graviditet, hvis den potentielle fordel opvejer den potentielle risiko for fosteret.
English: If you receive immunosuppressive medicinal products which inhibit the immune system, tell your doctor before starting the treatment.
Danish: Hvis du tager immunosuppresive lægemidler, som hæmmer immunsystemet, skal du fortælle det til din læge inden du starter behandlingen.
English: Data presented in the table below reflects: - exposure to Zyclara or vehicle in above mentioned studies (frequencies very common to uncommon and at greater frequency after vehicle).
Danish: De præsenterede data i nedenstående tabel afspejler: - Eksponering af Zyclara eller vehikel i ovennævnte undersøgelser (frekvens er meget almindelig til ikke almindelig og større frekvens efter vehikel).
English: - The active substance is imiquimod.
Danish: - Aktivt stof: Imiquimod.
English: Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, antivirals, ATC Code: D06BB10
Danish: Farmakoterapeutisk gruppe: Antibiotika og kemoterapeutika til udvortes brug, antivirale midler, ATCkode: D06BB10
English: Imiquimod is an immune response modifier.
Danish: Imiquimod er en immunrespons modifikator.
English: A different therapy is recommended if the treated lesion(s) show(s) insufficient response to Zyclara.
Danish: Det anbefales at anvende en anden behandling, hvis de(n) behandlede læsion(er) ikke reagerer tilfredsstillende på Zyclara.
English: General instructions during treatment
Danish: Generelle instruktioner under behandlingen
English: Apply this medicine to the affected area once a day just before bedtime.
Danish: Påfør medicinen på det angrebne område én gang dagligt lige før sengetid.
English: Imiquimod induces the release of interferon alpha (IFN-α) and other cytokines from a variety of human and animal cells (e.g. from human monocytes/macrophages and keratinocytes).
Danish: Imiquimod inducerer frigivelsen af alfa- interferon (IFN-α) og andre cytokiner fra en række humane og animalske celler (f.eks. fra humane monocytter makrofager og keratinocytter).
English: - Hair loss A small number of patients have experienced hair loss at the treatment site or surrounding area.
Danish: Et lille antal patienter har erfaret hårtab på behandlingsstedet eller det omkringliggende område.
English: Less than 0.9% of a topically applied single dose of radiolabelled imiquimod was absorbed through the skin of human subjects.
Danish: Mindre end 0,9 % af en topikalt anvendt enkeltdosis af radioaktivt mærket imiquimod blev absorberet gennem huden hos forsøgspersonerne.
English: • Do not cover the treated area with bandages or other dressings after you have applied this medicine.
Danish: • Du må ikke dække det behandlede område med plaster eller andre bandager, efter at du har anvendt medicinen.
English: This medicine should not be applied to areas larger than either the full face or balding scalp.
Danish: Denne medicin må ikke påføres på større områder end enten hele ansigtet eller den skaldede hovedbund.
English: The treatment area is the full face or balding scalp.
Danish: Behandlingsområdet er hele ansigtet eller den skaldede hovedbund.
English: Partially-used sachets should be discarded and not reused.
Danish: Delvist brugte breve skal kasseres og må ikke genbruges.
English: Zyclara is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.
Danish: Zyclara er indiceret til topikal behandling af klinisk typiske, ikke-hyperkeratotiske, ikke-hypertrofiske synlige eller palpable aktiniske keratoser (AK´er) i hele ansigtet eller skallede hovedbund hos immunkompetente voksne, hvor andre topikale behandlingsmuligheder er kontraindiceret eller mindre egnet.
English: If you experience these, stop using this medicine and tell your doctor immediately.
Danish: Hvis du oplever dette, skal du stoppe med at bruge denne medicin og øjeblikkeligt informere din læge.
English: You should continue treatment as prescribed.
Danish: Du bør fortsætte behandlingen som foreskrevet.
English: Zyclara should be applied as a thin film to the entire treatment area and rubbed in until the cream vanishes.
Danish: Zyclara bør anvendes som en tynd film på hele behandlingsområdet og gnides ind, indtil cremen forsvinder.
English: Because of concern for heightened sunburn susceptibility, use of sunscreen is encouraged, and patients should minimise or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Zyclara.
Danish: På grund af bekymring for øget modtagelighed for solskoldning, anbefales brug af solfaktorcreme, og patienterne bør minimere eller undgå udsættelse for naturligt eller kunstigt sollys (solarier eller UVA/B behandling), mens de bruger Zyclara.
English: He may advise you to stop applying this medicine for a few days (i.e. to have a short rest from treatment).
Danish: Han/hun vil måske råde dig til at stoppe med at påføre Zyclara i nogle dage (svarende til at have en kort pause fra behandlingen).
English: Skin infections during treatment with imiquimod have been observed.
Danish: Hudinfektioner i løbet af behandling med imiquimod er blevet observeret.
English: - if you are allergic to imiquimod or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer i denne medicin (angivet i punkt 6).
English: Studies in rabbits reveal a dermal lethal imiquimod dose of greater than 5 g/kg.
Danish: Studier på kaniner viser en dermal dødelig imiquimod dosis på mere end 5 g/kg.
English: This medicine is prescribed for the treatment of actinic keratosis in adults.
Danish: Dette lægemiddel er ordineret til behandling af aktinisk keratose hos voksne.
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 toksicitetsstudie på rotter blev der observeret markant fald i kropsvægt og forøget miltvægt ved 0,5 og 2,5 mg/kg; Lignende effekt blev ikke set i et fire måneder dermalt studie på mus.
English: The treatment starts with a daily application for two weeks, followed by a break without any application for two weeks, and then ends with a daily application again for two weeks.
Danish: Behandlingen starter med én daglig påføring i 2 uger, efterfulgt af en pause uden påføring i 2 uger, og derefter én daglig påføring igen i 2 uger.
English: These studies showed that imiquimod was better than topical diclofenac in preventing the histological progression of AK lesions to in-situ or invasive squamous cell carcinoma (SCC).
Danish: Disse studier viste, at imiquimod var bedre end topikal diclofenac til at forebygge histologisk progression af AK-læsioner til in-situ eller invasivt planocellulært karcinom (SCC).
English: Following accidental ingestion, nausea, emesis, headache, myalgia and fever could occur after a single dose of 200 mg imiquimod which corresponds to the content of more than 21 sachets of Zyclara.
Danish: Efter utilsigtet indtagelse, kan kvalme, opkastning, hovedpine, myalgi og feber forekomme efter en enkelt dosis på 200 mg imiquimod, hvilket svarer til indholdet af mere end 21 breve Zyclara.
English: In animal models imiquimod is effective against viral infections and acts as an antitumour agent principally by inducing release of alpha interferon and other cytokines.
Danish: I dyremodeller er imiquimod effektiv mod virale infektioner og virker som et antitumormiddel hovedsagelig ved at inducere frigørelse af alfa-interferon og andre cytokiner.
English: The treatment area should not be bandaged or otherwise occluded.
Danish: Behandlingsområdet bør ikke bandageres eller på anden måde tildækkes.