FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application.
Danish: I kliniske studier oplever omkring 50% af patienter en eller anden form for hudirritation på applikationsstedet.
English: • Avoid exposing the skin to long periods of sunlight or artificial sunlight such as tanning beds.
Danish: • Undgå at udsætte huden for langvarig sollys eller kunstigt sollys som f.eks. solarielys.
English: Post-marketing
Danish: Postmarketing
English: The incidence and nature of most adverse events were similar in the two treatment groups.
Danish: Incidens og natur af de fleste bivirkninger var ens i de to grupper.
English: • Protopic may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees.
Danish: • Protopic kan anvendes på de fleste steder af kroppen, også i ansigtet og på halsen, og på bøjefurene af albuer og knæ.
English: These symptoms are usually mild to moderate and generally go away within one week of using Protopic.
Danish: Disse symptomer er sædvanligvis lette til moderate og forsvinder almindeligvis efter en uges brug af Protopic.
English: An interaction study with protein-conjugated vaccine against Neisseria menigitidis serogroup C has been investigated in children aged 2-11 years.
Danish: Et interaktionsstudie med en proteinkonjugeret vaccine mod Neisseria meningitidis serogruppe C er blevet udført hos børn i alderen 2-11 år.
English: • Before applying Protopic after a bath or shower, be sure your skin is completely dry.
Danish: • Før påsmøring af Protopic salve efter et bad skal du være sikker på, at huden er fuldstændig tør.
English: Paediatric population Frequency, type and severity of adverse reactions in children are similar to those reported in adults.
Danish: Pædiatrisk population Bivirkningernes hyppighed, type og sværhedsgrad hos børn ligner dem, der er indberettet for voksne.
English: In a subanalysis of a pooled population of patients with moderate to severe atopic dermatitis these differences remained statistically significant (Table 4).
Danish: I en subanalyse af en samlet patientpopulation med moderat til alvorlig atopisk dermatitis, forblev disse forskelle statistisk signifikante (tabel 4).
English: Median mEASI as Percentage of Baseline mean AUC (Primary Endpoint)§
Danish: Median mEASI som procent af baseline mean AUC (Primær parameter)§
English: While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known.
Danish: Følgende er observeret, men den kliniske betydning af disse observationer i atopisk dermatitis er ikke kendt.
English: If no signs of improvement are seen after two weeks of treatment, further treatment options should be considered.
Danish: Hvis der ikke ses tegn på forbedring efter to ugers behandling, bør yderligere behandlingsmuligheder overvejes.
English: Ophthalmic Herpes Infection*
Danish: Oftalmisk herpesinfektion*
English: At the first signs of recurrence (flares) of the disease symptoms, treatment should be re-initiated.
Danish: Ved de første tegn på tilbagevenden af sygdomssymptomerne (eksemudbrud) bør behandlingen genoptages.
English: Protopic can be used for short-term and intermittent long-term treatment.
Danish: Protopic kan anvendes til korttidsbehandling og intermitterende langtidsbehandling.
English: Local skin infection regardless of specific aetiology including but not limited to:
Danish: Lokale hudinfektioner uanset specifik ætiologi herunder, men ikke begrænset til:
English: Oral use of tacrolimus is also not recommended to treat these skin conditions.
Danish: Oral indtagelse af tacrolimus anbefales heller ikke til behandling af disse hudsygdomme.
English: These skin conditions may increase systemic absorption of tacrolimus.
Danish: Disse hudsygdomme kan øge den systemiske absorption af tacrolimus.
English: Analysis of the response rate at week 5 showed equivalence between the treatment groups (hydrocortisone 98.3%, tacrolimus ointment 95.4%; 7-11 years: 100% in both arms).
Danish: Analyse af responsraten i uge 5 viste ækvivalens mellem behandlingsgrupperne (hydrocortison 98,3%, tacrolimussalve 95,4%; 7-11 år: 100% i begge arme).
English: Generally, improvement is seen within one week of starting treatment.
Danish: Generelt ses forbedring inden for en uge efter behandlingsstart.
English: Protopic with alcohol
Danish: Brug af Protopic sammen med alkohol
English: During this period all patients and control subjects (n=44) received a primary immunisation and a rechallenge with a protein-conjugate vaccine against Neisseria menigitidis serogroup C.
Danish: I denne periode fik alle patienter og kontrolgruppen (n=44) en primær immunisering og en revaccination med en proteinkonjugeret-vaccine mod Neisseria meningitidis serogruppe C.
English: It is unclear whether the effect of tacrolimus is due to systemic immunosuppression or a local effect.
Danish: Det er uklart om effekten skyldes en systemisk immunsuppression eller en lokal effekt.
English: Following repeated topical application of the ointment the average half-life of tacrolimus was estimated to be 75 hours for adults and 65 hours for children.
Danish: Efter gentagen lokal applikation af salven, beregnede man halveringstiden til 75 timer for voksne og 65 timer for børn.
English: Treatment should be started twice a day for up to three weeks.
Danish: Behandlingen bør påbegyndes med applikation to gange om dagen i op til 3 uger.
English: Based on changes from baseline in EASI score and body surface area affected, patients regardless of age had improvement in their atopic dermatitis at all subsequent time points.
Danish: På basis af ændringerne fra baseline i EASI og arealet af afficeret område havde patienterne, uanset alder, bedring af den atopiske dermatitis ved alle de følgende målinger.
English: Drug level increased* (see section
Danish: Øget medicinkoncentration * (se pkt.
English: If you accidentally swallow some ointment
Danish: Hvis du ved et uheld kommer til at indtage noget salve
English: If you forget to use Protopic
Danish: Hvis du har glemt at bruge Protopic
English: • If you have any skin malignancies (tumours) or if you have a weakened immune system
Danish: • hvis du har ondartede hudsygdomme (tumorer), eller hvis du har et svækket immunsystem
English: Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
Danish: Systemiske karcinogenicitets undersøgelser i mus (18 måneder) og rotter (24 måneder) viste ingen tegn på tumorogent potentiale.
English: If you do not see any improvement after two weeks, see your doctor about other possible treatments.
Danish: Hvis du ikke ser bedring efter 2 uger skal du tale med lægen om andre mulige behandlinger.
English: Pharmacotherapeutic group: Other dermatologicals, ATC code: D11AH01
Danish: Farmakoterapeutisk klassifikation: Dermatologiske midler, andre, ATC-kode: D11AH01
English: If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before.
Danish: Hvis du glemmer at påsmøre salven på det fastsatte tidspunkt, påsmør salve straks du kommer i tanke om det, og fortsæt behandlingen som tidligere.
English: Protopic treatment should begin at the first appearance of signs and symptoms.
Danish: Behandlingen med Protopic bør påbegyndes, når de første tegn og symptomer viser sig.
English: Patients, particularly paediatric patients should be continuously evaluated during treatment with Protopic with respect to the response to treatment and the continuing need for treatment.
Danish: Patienterne, specielt børn, bør løbende evalueres under behandlingen med Protopic med hensyn til behandlingsrespons og behovet for fortsat behandling.
English: Herpes simplex, Herpes virus infection, Kaposi's varicelliform eruption*
Danish: Herpes simplex, Herpes virus infektion, Kaposis varicelliforme eruption*
English: • The effect of treatment with Protopic on the developing immune system in children, especially the young, has not been established.
Danish: • Virkningen af behandling med Protopic salve på udviklingen af immunsystemet hos børn, specielt mindre børn, kendes ikke.
English: • If your doctor tells you to use Protopic twice weekly to keep your atopic dermatitis cleared, your condition should be reviewed by your doctor at least every 12 months, even if it remains under control.
Danish: • Hvis din læge siger, at du skal bruge Protopic to gange ugentligt for at undgå eksemudbrud, bør lægen vurdere din tilstand mindst hver 12. måned, selv om sygdommen forbliver under kontrol.
English: *The adverse reaction has been reported during post-marketing experience Post-marketing
Danish: *Bivirkningen er blevet rapporteret i forbindelse med erfaringer efter markedsføringen Postmarketing
English: Other medicines, cosmetics and Protopic
Danish: Brug af anden medicin og af kosmetik sammen med Protopic
English: Patients with atopic dermatitis treated with Protopic have not been found to have significant systemic tacrolimus levels.
Danish: Patienter med atopisk dermatit behandlet med Protopic er ikke set at have signifikante systemiske tacrolimusniveauer.
English: The efficacy and safety of Protopic was assessed in more than 18,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
Danish: Virkning og sikkerhed er blevet undersøgt i mere end 18.500 patienter behandlet med tacrolimussalve i fase I til fase III kliniske afprøvninger.
English: In animals, tacrolimus ointment suppressed inflammatory reactions in experimental and spontaneous dermatitis models that resemble human atopic dermatitis.
Danish: I dyr undertrykker tacrolimussalve inflammatoriske reaktioner i eksperimentelle og spontane dermatitismodeller, der ligner den humane atopiske dermatitis.
English: Do not try to induce vomiting.
Danish: Du skal ikke forsøge at fremkalde en opkastning.
English: As with any topical medicinal product, patients should wash their hands after application if the hands are not intended for treatment.
Danish: Som ved alle andre topiske lægemidler skal patienten vaske hænder efter påsmøring, med mindre man også ønsker at behandle hænderne.
English: The overall incidence of adverse events tended to decrease as the study progressed for all patients independent of age.
Danish: Den samlede incidens af bivirkninger mindskedes i studiets forløb for alle patienter uanset alder.
English: Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap.
Danish: Laminat tube med en inderbeklædning af low-density-polyætylen lukket med et hvidt polypropylen skruelåg.
English: It is supplied in tubes containing 10, 30 or 60 grams of ointment.
Danish: Den findes i tuber med enten 10, 30 eller 60 gram salve.
English: There was no evidence of systemic accumulation of tacrolimus in patients (adults and children) treated for prolonged periods (up to one year) with tacrolimus ointment.
Danish: Der har ikke været tegn på systemisk akkumulation af tacrolimus i patienter (voksne og børn), der er blevet behandlet med tacrolimussalve i længere perioder (op til 1 år).
English: Via its binding to a specific cytoplasmic immunophilin (FKBP12), tacrolimus inhibits calciumdependent signal transduction pathways in T cells, thereby preventing the transcription and synthesis of IL-2, IL-3, IL-4, IL-5 and other cytokines such as GM-CSF, TNF-α and IFN-γ.
Danish: Via binding til et specifikt cytoplasmisk immunophilin (FKBP12) hæmmer tacrolimus calciumafhængig signal transduktion i T-celler og hindrer på denne måde transkription og syntese af IL-2, IL-3, IL-4, IL-5 og andre cytokiner som GM-CSF, TNF-α og IFN-γ.
English: The pharmacokinetics of tacrolimus after topical application are similar to those reported in adults, with minimal systemic exposure and no evidence of accumulation (see above).
Danish: Tacrolimus' farmakokinetik efter lokal applikation ligner den, der er indberettet for voksne med minimal systemisk eksponering og ingen tegn på akkumulering (se ovenfor).
English: Elderly Specific studies have not been conducted in older people (see flare treatment section above).
Danish: Der er ikke foretaget specifikke studier med ældre personer (se ”Behandling af eksemudbrud” ovenfor).
English: Data from healthy human subjects indicate that there is little or no systemic exposure to tacrolimus following single or repeated topical application of tacrolimus ointment.
Danish: Data fra sunde forsøgspersoner indicerer, at der kun er ringe eller ingen systemisk eksponering af tacrolimus efter en enkelt eller gentagen applikation af tacrolimussalve.
English: Occlusive dressings are not recommended.
Danish: Okklusionsforbinding anbefales ikke.
English: If symptoms reappear you should use Protopic twice daily as outlined above and arrange to see your doctor to review your treatment.
Danish: Hvis symptomerne vender tilbage, bør du benytte Protopic to gange daglig som anvist ovenfor og aftale tid hos din læge til vurdering af din behandling.
English: Adverse reactions with suspected relationship to treatment are listed below by system organ class.
Danish: Bivirkninger, der formodes at være relaterede til behandlingen, er angivet nedenfor efter systemorganklasser.
English: After 12 months treatment, a review of the patient`s condition should be conducted by the physician and a decision taken whether to continue maintenance treatment in the absence of safety data for maintenance treatment beyond 12 months.
Danish: Efter 12 måneders behandling bør patientens kliniske tilstand vurderes af lægen, og der skal tages stilling til, om vedligeholdelsesbehandlingen skal fortsættes, selv om der ikke findes sikkerhedsdata for vedligeholdelsesbehandling ud over 12 måneder.
English: The potential for local immunosuppression (possibly resulting in infections or cutaneous malignancies) in the long term (i.e. over a period of years) is unknown (see section 5.1).
Danish: Risikoen for lokal immunsuppression (der muligvis kan medføre infektioner eller maligne hudlidelser) ved langtidsbehandling (dvs. flere år) er ukendt (se pkt.
English: The majority of these cases were related to infections (skin, respiratory tract, tooth) and resolved with appropriate antibiotic therapy.
Danish: Flertallet af disse har været relateret til infektioner (hud, luftveje, tænder) og svandt ved behandling med antibiotika.
English: If you spend time outdoors after applying Protopic, use a sunscreen and wear loose fitting clothing that protects the skin from the sun.
Danish: Hvis du opholder dig udendørs efter at have påsmurt Protopic, brug da et solbeskyttelsesmiddel og tag løst tøj på, der beskytter huden mod solen.
English: Patients may be at an increased risk of folliculitis, acne and herpes viral infections.
Danish: Patienterne har muligvis en forhøjet risiko for folliculitis, akne og virusinfektioner.
English: If accidentally applied to these areas, the ointment should be thoroughly wiped off and/or rinsed off with water.
Danish: Hvis salven ved et uheld appliceres på disse områder, skal salven tørres grundigt af og/eller skylles af med vand.
English: Physicians should advise patients on appropriate sun protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing.
Danish: Lægen bør informere patienterne om egnede solbeskyttelsesmetoder som f.eks. minimering af den tid, der tilbringes i solen, brug af solbeskyttende cremer samt tildækning af huden med passende beklædning.
English: The use of Protopic ointment under occlusion has not been studied in patients.
Danish: Brug af Protopic salve under okklusion er ikke undersøgt på patienter.
English: Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet ved systemisk administration (se pkt.
English: Protopic treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Danish: Behandling med Protopic skal initieres af læger med erfaring i diagnosticering og behandling af atopisk dermatitis.
English: *The adverse reaction has been reported during post-marketing experience
Danish: *Bivirkningen er blevet rapporteret i forbindelse med erfaringer efter markedsføringen
English: Between applications there should be 2-3 days without Protopic treatment.
Danish: Mellem påsmøringerne bør der være 2-3 dage uden Protopicbehandling.
English: As systemic exposure is low with tacrolimus ointment, the high binding of tacrolimus (>98.8%) to plasma proteins is considered not to be clinically relevant.
Danish: Da den systemiske eksponering er lav ved behandling med tacrolimussalve, er den kraftige plasmabinding af tacrolimus (> 98,8%) næppe klinisk relevant.
English: Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression.
Danish: Protopic bør ikke anvendes til patienter med medfødt eller erhvervet immundefekt eller til patienter i behandling med lægemidler, som forårsager immunsuppression.
English: In a study of maintenance treatment (twice weekly treatment) in adults and children with moderate and severe atopic dermatitis the following adverse events were noted to occur more frequently than in the control group: application site impetigo (7.7% in children) and application site infections (6.4% in children and 6.3% in adults).
Danish: I et studie med vedligeholdelsesbehandling (behandling to gange ugentlig) hos voksne og børn med moderat til svær atopisk dermatitis forekom følgende bivirkninger oftere end i kontrolgruppen: impetigo på applikationsstedet (7,7% hos børn) og infektioner på applikationsstedet (6,4% hos børn og 6,3% hos voksne).
English: The response rate in the 0.1% tacrolimus group (71.6%) was significantly higher than that in the topical corticosteroid based treatment group (50.8%; p<0.001; Table 1).
Danish: Responsraten i 0,1% tacrolimusgruppen (71,6%) var signifikant højere end den i gruppen med lokal kortikosteroid behandling (50,8%, p< 0,001; tabel 1).
English: No effect on immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity has been observed (see section 5.1).
Danish: Der er ikke observeret nogen virkning på umiddelbart vaccinerespons, generering af immunhukommelse eller humoral og cellemedieret immunitet (se pkt.
English: If you are prescribed light therapy, inform your doctor that you are using Protopic as it is not recommended to use Protopic and light therapy at the same time.
Danish: Hvis du får ordineret lysbehandling, skal du fortælle lægen, at du bruger Protopic, da samtidig brug af Protopic og lysbehandling frarådes.
English: There is no experience with concomitant use of systemic steroids or immunosuppressive agents.
Danish: Der er ingen erfaring med samtidig behandling med systemiske steroider eller immunsuppressive lægemidler.
English: • burning sensation and itching
Danish: • brændende fornemmelse og kløe
English: However, both the extent and the rate of topical absorption of tacrolimus decrease as the skin heals.
Danish: Men både størrelsen og hastigheden af den lokale absorption falder i takt med, at huden heler.
English: Protopic ointment has no or negligible influence on the ability to drive and use machines.
Danish: Protopic salve påvirker ikke eller kun i ubetydelig grad evnen til at føre bil og betjene maskiner.
English: Embryo/foetal toxicity was observed in rats and rabbits, but only at doses that caused significant toxicity in maternal animals.
Danish: I rotter og kaniner ses embryo/føtal toksisk effekt, men kun i doser der har signifikant toksisk effekt på moderdyret.
English: In the fourth trial, approximately 800 patients (aged ≥2 years) received 0.1% tacrolimus ointment intermittently or continuously in an open-label, long-term safety study for up to four years, with 300 patients receiving treatment for at least three years and 79 patients receiving treatment for a minimum of 42 months.
Danish: I det fjerde studie blev omkring 800 patienter (≥ 2 år gamle) behandlet intermitterende eller kontinuerligt i op til 4 år med 0,1% tacrolimussalve i et åbent langtidsstudie af sikkerhed med 300 patienter der blev behandlet i mindst 3 år og 79 patienter der blev behandlet i mindst 42 måneder.
English: Talk to your doctor before using Protopic:
Danish: Kontakt lægen inden du begynder at bruge Protopic:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Butylhydroxytoluene (E321) All-rac-α-tocopherol
Danish: Butylhydroxytoluen (E321) All-rac-α-tocopherol
English: Impetigo, a superficial bacterial skin infection that usually produces blisters or sores on skin, has been reported in children.
Danish: Børnesår, en overfladisk bakterieinfektion, der sædvanligvis danner blærer eller sår på huden, er indberettet for børn.
English: The primary endpoint in both studies was the number of disease exacerbations requiring a “substantial therapeutic intervention” during the DCP, defined as an exacerbation with an IGA of 3-5 (i.e. moderate, severe and very severe disease) on the first day of the flare, and requiring more than 7 days treatment.
Danish: Det primære endepunkt for begge studier var antallet af eksemudbrud, der krævede en 'betydelig terapeutisk intervention' i DCP, defineret som en forværring med IGA på 3-5 (dvs. moderat, alvorlig eller meget alvorlig sygdom) på den første dag med eksemudbrud, og som krævede mere end 7 dages behandling.
English: Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin with minimal diffusion into the systemic circulation.
Danish: Efter lokal applikation af tacrolimussalve, bliver tacrolimus selektivt optaget i huden med minimal diffusion til den systemiske cirkulation.
English: Mechanism of action and pharmacodynamic effects The mechanism of action of tacrolimus in atopic dermatitis is not fully understood.
Danish: Virkningsmekanisme og farmakodynamisk virkning Tacrolimus virkningsmekanisme i atopisk dermatitis er ikke fuldt klarlagt.
English: A seven-month, double blind, randomised parallel group study of paediatric patients (2-11 years) with moderate to severe atopic dermatitis was performed.
Danish: Et syv måneder langt dobbeltblindet, randomiseret, parallelgruppe-studie hos pædiatriske patienter (211 år) med moderat til svær atopisk dermatitis er blevet udført.
English: Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant.
Danish: Protopic salve må ikke anvendes på læsioner, som bedømmes til at være potentielt maligne eller præmaligne.
English: Protopic ointment should not be applied under occlusion because this method of administration has not been studied in patients (see section 4.4).
Danish: Protopic salve må ikke benyttes under okklusion, da denne administrationsmåde ikke er undersøgt hos patienter (se pkt.
English: Lymphadenopathy was uncommonly (0.8%) reported in clinical trials.
Danish: Lymphadenopati er i sjældne tilfælde (0,8%) set i kliniske afprøvninger.
English: Protopic contains butylhydroxytoluene (E321)
Danish: Protopic indeholder butylhydroxytoluen (E321)
English: Afterwards the frequency of application should be reduced to once a day until clearance of the lesion (see section 4.4).
Danish: Derefter bør applikationsfrekvensen reduceres til en gang om dagen, indtil læsionen er helet (se pkt.
English: The three most common adverse events reported were flu-like symptoms (cold, common cold, influenza, upper respiratory infection, etc.), pruritus and skin burning.
Danish: De tre mest almindelige bivirkninger, der blev rapporteret, var influenzalignende symptomer (snue, forkølelse, influenza, infektioner i de øvre luftveje o.s.v.) kløe og en brændende fornemmelse i huden.