FrancophonIA/ELRC3.0 huggingface dataset:
English: • local skin infection regardless of specific cause including but not limited to: inflamed or infected hair follicles, cold sores, generalised herpes simplex infections
Danish: • lokal hudinfektion uanset specifik årsag, herunder men ikke begrænset til: vævsirritation eller betændelse i hårsække, herpesvirus-infektioner (f.eks. forkølelsessår, udbredte herpes simplex infektioner)
English: The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent.
Danish: Det aktive stof i Protopic, tacrolimusmonohydrat, er et immunomodulerende lægemiddel.
English: The results of this multicentre, double-blind, randomised trial showed that tacrolimus ointment, 0.03% and 0.1%, is significantly more effective (p<0.001 for both) than 1% hydrocortisone acetate ointment (Table 2).
Danish: Resultaterne af denne multicenter, dobbelt-blinde, randomiserede afprøvning viste at tacrolimussalve, 0,03% og 0,1% har signifikant bedre effekt (p<0,001 for begge) end 1% hydrocortisonacetat-salve (tabel 2).
English: 36 days
Danish: 36 dage
English: Improvement is usually seen within one week.
Danish: Man ser sædvanligvis bedring indenfor den første uge.
English: § lower values = greater improvement
Danish: § højere værdi = større bedring
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 behandlede):
English: The incidence of local skin burning was higher in the tacrolimus treatment groups than in the hydrocortisone group.
Danish: Incidensen af brændende følelse i huden var højere i tacrolimus behandlingsgruppen end i hydrocortisongruppen.
English: Mutagenicity In vitro and in vivo tests did not indicate a genotoxic potential of tacrolimus.
Danish: Med relevante in vitro og in vitro tests har man ikke kunnet påvise tegn på mutagent potentiale af tacrolimus.
English: In the comparator arm patients received 1% hydrocortisone acetate ointment (HA) for head and neck and 0.1% hydrocortisone butyrate ointment for trunk and limbs (n=111) twice a day for 2 weeks and subsequently HA twice a day to all affected areas.
Danish: I komparatorarmen fik patienterne 1% hydrocortisonacetat-salve (HA) til hoved og hals og 0,1% hydrocortisonbutyrat-salve til overkrop og ekstremiteter (n=111) to gange dagligt i 2 uger og derefter HA to gange dagligt på alle afficerede områder.
English: Cutaneous use Read the package leaflet before use.
Danish: Kutan anvendelse Læs indlægssedlen inden brug.
English: Care should be exercised if applying Protopic to patients with extensive skin involvement over an extended period of time, especially in children (see section 4.2).
Danish: Der skal udvises forsigtighed, hvis Protopic anvendes til patienter som skal have et stort hudareal behandlet over en længere tidsperiode, især hvis det drejer sig om børn (se pkt.
English: Twice daily treatment with 0.03% tacrolimus ointment was more effective than once daily administration (Table 3).
Danish: 0,03% tacrolimussalve appliceret 2 gange om dagen var mere effektivt end applikation en gang om dagen (tabel 3).
English: Hydrocortisone acetate 1% (N=185)
Danish: Hydrocortison acetat 1% (N=185)
English: The development of any new change different from previous eczema within a treated area should be reviewed by the physician.
Danish: Enhver forandring i huden på behandlingsområdet, som er forskellig fra tidligere eksem, skal undersøges af en læge.
English: Adults (16 years of age and older)
Danish: Voksne (16 år og ældre)
English: Protopic 0.1 % ointment is indicated in adults and adolescents (16 years of age and above)
Danish: Protopic 0,1% salve er indiceret til voksne og unge (16 år og derover).
English: Due to the nature of the ointment vehicle, induction of vomiting or gastric lavage is not recommended.
Danish: På grund af salvegrundlagets sammensætning kan provokation af opkastning eller maveskylning ikke anbefales.
English: Children (2 years of age and older)
Danish: Børn (2 år og ældre)
English: Protopic ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes.
Danish: Protopic salve kan benyttes overalt på kroppen, inklusive ansigt, hals og ekstremiteternes fleksurarealer men ikke på slimhinder.
English: A very small number of people who have used Protopic ointment have had malignancies (for example, skin or lymphoma).
Danish: Ganske få personer, som har anvendt Protopic salve, har fået ondartede hudsygdomme (f.eks. hudtumorer eller lymfomer).
English: The effect of treatment with Protopic ointment on the developing immune system of children aged below 2 years has not been established (see section 4.1).
Danish: Det er ikke klarlagt, hvilken virkning behandling med Protopic salve har på udviklingen af immunsystemet hos børn under 2 år (se pkt.
English: If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible.
Danish: Hvis du ved en fejltagelse er kommet til at indtage salven, skal du hurtigst muligt kontakte din læge eller apoteket.
English: Table 1: Efficacy at month 3
Danish: Tabel 1: Virkning ved måned 3
English: Topical corticosteroid regimen§ (N=485)
Danish: Lokal kortikosteroidbehandling § (N=485)
English: Following twice-weekly treatment application site infections have been reported in adults.
Danish: I forbindelse med behandling to gange ugentligt er der indberettet infektioner på påsmøringsstedet hos voksne.
English: When administered intravenously, tacrolimus has been shown to have a low clearance rate.
Danish: Efter intravenøs administrering er tacrolimus vist at være et stof med lav clearance.
English: Median number of DEs adjusted for time at risk (% of patients without any DE periods)
Danish: Median af antallet af eksemudbrud justeret for 'time at risk' (% patienter uden nogen eksemudbrudsperioder) Median af tiden til første eksemudbrud
English: In both studies, patients with active disease entered an open-label period (OLP) during which they treated affected lesions with tacrolimus ointment twice daily until improvement had reached a predefined score (Investigator's Global Assessment [IGA] ≤2, i.e. clear, almost clear or mild disease) for a maximum of 6 weeks.
Danish: I begge studier indgik patienter med aktiv sygdom i en åben behandlingsperiode på maksimalt 6 uger, hvor de behandlede afficerede læsioner med tacrolimussalve to gange daglig, indtil forbedringen havde nået en prædefineret score (Investigator's Global Assessment [IGA] ≤ 2, dvs. helet, næsten helet eller kun mild sygdom).
English: 146 days
Danish: 146 dage
English: Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common.
Danish: Alkohol intolerance (flushing eller hudirritation efter indtagelse af en alkoholisk drik) er også almindelig.
English: Since commercial availability a very small number of people who have used Protopic ointment have had malignancies (for example lymphoma, including skin lymphoma, and other skin tumours).
Danish: Efter markedsføring har et meget lille antal personer, som har brugt Protopic salve, fået en ondartet sygdom (f.eks. lymfom inklusive lymfom i huden og andre hudtumorer).
English: 15 days
Danish: 15 dage
English: Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Danish: Behandling af moderat til svær atopisk dermatitis til forebyggelse af eksemudbrud og forlængelse af sygdomsfrie intervaller hos patienter, som oplever hyppige eksacerbationer af sygdommen (dvs. forekommer 4 gange eller mere om året), og som har haft et initialt respons på maksimalt 6 ugers behandling med tacrolimussalve to gange daglig (læsioner helet, næsten helet eller kun mildt afficeret).
English: If your lymph nodes become swollen during treatment with Protopic, consult your doctor.
Danish: Hvis du får hævede lymfekirtler under behandlingen med Protopic, skal du tale med lægen.
English: Adults and adolescents (16 years of age and above)
Danish: Voksne og unge (16 år og derover)
English: • The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321) and all-rac-α-tocopherol.
Danish: - Øvrige indholdsstoffer: Hvid vaselin, paraffinolie, propylencarbonat, hvidt voks, paraffin, butylhydroxytoluen (E321) og all-rac-α-tocopherol.
English: Systemic exposure from topical application of tacrolimus ointment is low (< 1.0 ng/ml) and is unlikely to be affected by concomitant use of substances known to be inhibitors of CYP3A4.
Danish: Den systemiske eksponering fra lokal anvendelse af tacrolimus er lav (< 1,0 ng/ml) og påvirkes næppe ved samtidig brug af kendte inhibitorer of CYP3A4.
English: • If you have a cutaneous Graft Versus Host Disease (an immune reaction of the skin which is a common complication in patients who have undergone a bone marrow transplant).
Danish: • hvis du har hudreaktioner, som skyldes, at transplanteret knoglemarv reagerer mod kroppens egne celler (kutan transplantat mod vært reaktion − en immunreaktion fra huden, som er en hyppig komplikation hos patienter, der er blevet knoglemarvstransplanteret).
English: Application site warmth, Application site erythema, Application site pain, Application site irritation, Application site paraesthesia,
Danish: Varme på applikationsstedet, Erytem på applikationsstedet, Smerte på applikationsstedet, Irritation på applikationsstedet, Paræstesi på applikationsstedet, Udslæt på applikationsstedet
English: Children (2 years of age and above) should use the lower strength Protopic 0.03% ointment.
Danish: Børn (2 år og derover) bør anvende den lavere styrke Protopic 0,03% salve.
English: Table 2: Efficacy at week 3
Danish: Tabel 2: Virkning ved uge 3
English: Concomitant use of other topical preparations has not been assessed.
Danish: Samtidig behandling med andre hudmidler er ikke blevet undersøgt.
English: Two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment) are available for adult patients (16 years of age and older).
Danish: Der findes to styrker Protopic salve (Protopic 0,03% og Protopic 0,1% salve) til brug for voksne patienter (16 år og derover).
English: The purpose of the third multicentre, double-blind, randomised study was the assessment of efficacy and safety of 0.03% tacrolimus ointment applied once or twice a day relative to twice daily administration of 1% hydrocortisone acetate ointment in children with moderate to severe atopic dermatitis.
Danish: Formålet med det tredje multicenter, dobbelt-blind, randomiserede studie var at undersøge virkning og sikkerhed af 0,03% tacrolimussalve, når denne blev appliceret 1-2 gange om dagen sammenlignet med administrering af 1% hydrocortisonacetat 2 gange om dagen til børn med moderat til svær atopisk dermatitis.
English: The hepatic clearance of systemically available tacrolimus could be reduced in subjects with severe hepatic impairment, or in subjects who are cotreated with drugs that are potent inhibitors of CYP3A4.
Danish: Den hepatiske clearance af systemisk tilgængeligt tacrolimus kan være nedsat hos patienter med svær nedsættelse af leverfunktionen, eller ved samtidig behandling med lægemidler, der er potente inhibitorer af CYP3A4.
English: Children • Protopic ointment is not approved for children younger than 2 years of age.
Danish: • Protopic salve er ikke godkendt til børn under 2 år.
English: In the second trial, children aged from 2 to 15 years with moderate to severe atopic dermatitis received twice daily treatment for three weeks of 0.03% tacrolimus ointment, 0.1% tacrolimus ointment or 1% hydrocortisone acetate ointment.
Danish: I den anden kliniske afprøvning blev børn i alderen 2 år til 15 år med moderat til svær atopisk dermatitis behandlet 2 gange om dagen i 3 uger med 0,03% tacrolimussalve, 0,1% tacrolimussalve eller 1% hydrocortisonacetat-salve.
English: Mean (SD) percentage of days of DE exacerbation treatment DE: disease exacerbation P<0.001 in favour of tacrolimus ointment 0.1% (adults) and 0.03% (children) for the primary and key secondary endpoints
Danish: P<0.001 til fordel for tacrolimussalve 0,1% (voksne) og 0,03% (børn) for primære og væsentlige sekundære endepunkter
English: Protopic contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Danish: Protopic indeholder butylhydroxytoluen (E321), som kan medføre lokale hudreaktioner (f.eks. kontaktdermatitis) eller irritation af øjne og slimhinder.
English: How to use Protopic
Danish: Sådan skal du bruge Protopic
English: Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage)
Danish: Alkoholintolerance (flushing eller hudirritation efter indtagelse af alkohol)
English: • Do not cover the skin being treated with bandages or wraps.
Danish: • Dæk ikke behandlede områder med forbindinger.
English: 17 days
Danish: 17 dage
English: Table 3: Efficacy at week 3
Danish: Tabel 3: Virkning ved uge 3
English: You may be told by your doctor to use Protopic 0.1% ointment twice weekly once your atopic dermatitis has cleared or almost cleared.
Danish: Din læge kan fortælle dig, at du skal bruge Protopic 0,1% salve to gange ugentlig, når dit eksem er helet eller næsten helet.
English: Protopic alters the abnormal immune response and relieves the skin inflammation and the itch.
Danish: Protopic dæmper den unormale hudreaktion og lindrer hudinflammation og kløe.
English: Hydrocortisone acetate 1% Twice daily (N=207)
Danish: Hydrocortisonacetat 1% 2 gange om dagen (N = 207)
English: While using Protopic, drinking alcohol may cause the skin or face to become flushed or red and feel hot.
Danish: Når man er i behandling med Protopic, kan indtagelse af alkohol medføre pludselig rødmen (flush) og varme i huden.
English: white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321), all-rac-α-tocopherol.
Danish: hvid vaselin, paraffinolie, propylencarbonat, hvidt voks, paraffin, butylhydroxytoluen (E321), all-racα-tocopherol.
English: When observed, blood concentrations exceeding 1.0 ng/ml were transient.
Danish: I de tilfælde man fandt blodkoncentrationer > 1 ng/ml var disse kun af kort varighed.
English: 142 days
Danish: 142 dage
English: In a six-month multicentre double-blind randomised trial, 0.1% tacrolimus ointment was administered twice-a-day to adults with moderate to severe atopic dermatitis and compared to a topical corticosteroid based regimen (0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck).
Danish: I en seks-måneders multicenter, dobbelt-blind, randomiseret afprøvning blev 0,1% tacrolimussalve administreret 2 gange om dagen til voksne med moderat til svær atopisk dermatitis, og blev sammenlignet med lokal kortikosteroid behandling (0,1% hydrocortisonbutyrat på kroppen og ekstremiteter og 1% hydrocortisonacetat på ansigt og hals).
English: Slightly lower body weight gain in females was the only systemic change observed in micropigs at high ointment concentrations (3%).
Danish: En noget mindre øgning af kropsvægten i hundyr var eneste tegn på systemisk eksponering i minigrise ved brug af salve med højt indhold af tacrolimus (3%).
English: The lowest tacrolimus blood concentration at which systemic effects can be observed is not known.
Danish: Det vides ikke hvor lave tacrolimus blodkoncentrationer, der vil kunne give systemisk effekt.
English: Children (2 years of age and above)
Danish: Børn (2 år og derover)
English: There should be 2-3 days without Protopic treatment between applications.
Danish: Der bør være 2 - 3 dage mellem påsmøringerne af Protopic.
English: Adults and adolescents (16 years of age and above) Adult patients should use Protopic 0.1% ointment.
Danish: Voksne patienter (16 år gamle og ældre) bør anvende Protopic 0,1% salve.
English: Uncommon (may affect fewer than 1 in 100 people): • acne
Danish: Ikke almindelig (kan påvirke mellem 1 og 10 ud af 1.000 behandlede): • akne
English: Usually, treatment is started with Protopic 0.1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared.
Danish: Sædvanligvis starter man behandlingen med Protopic 0,1% salve 2 gange om dagen, en gang om morgenen og en gang om aftenen, indtil eksemen er forsvundet.
English: Tacrolimus Twice weekly (N=78)
Danish: Tacrolimus To gange ugentlig (N=78)
English: If the ointment gets on any of these areas, it should be thoroughly wiped off and/or rinsed off with water.
Danish: skal den omhyggeligt tørres af og/eller skylles af med vand.
English: Protopic ointment contains butylhydroxytoluene (E321) as an excipient, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Danish: Protopic salve indeholder hjælpestoffet butylhydroxytoluen (E321), som kan medføre lokale hudreaktioner (f.eks. kontaktdermatitis) eller irritation af øjne og slimhinder.
English: Clinical data have shown that tacrolimus concentrations in systemic circulation after topical administration are low and, when measurable, transient.
Danish: Kliniske data har vist, at koncentrationen af tacrolimus i den systemiske cirkulation er lav efter applikation på huden, og i de tilfælde koncentrationen har været målelig, kun målelig i kortere perioder.
English: Treatment should be started with Protopic 0.1% twice a day and treatment should be continued until clearance of the lesion.
Danish: Behandlingen bør begyndes med Protopic 0,1% to gange om dagen, indtil læsionen er helet.
English: Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids.
Danish: Behandling af moderat til svær atopisk dermatitis hos børn, der ikke har responderet tilfredsstillende på konventionelle behandlinger såsom topikale kortikosteroider.
English: Afterwards the ointment should be used once a day on each affected region of the skin until the eczema has gone away.
Danish: Derefter skal salven benyttes 1 gang om dagen på de angrebne hudområder indtil eksemen er forsvundet.
English: • If you have infected lesions.
Danish: • hvis du har betændt, beskadiget hud.
English: Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk.
Danish: Data viser, at tacrolimus udskilles i human mælk efter systemisk administration.
English: Protopic ointment should be applied as a thin layer to affected or commonly affected areas of the skin.
Danish: Protopic salve skal påsmøres i et tyndt lag på det afficerede eller sædvanligvis afficerede hudområde.
English: Protopic 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids.
Danish: Protopic 0,03% salve benyttes til at behandle moderat til svær atopisk dermatitis (eksem) hos voksne, der ikke responderer tilfredsstillende på eller ikke tåler konventionelle behandlinger såsom topikale kortikosteroider og til børn (2 år og ældre), der ikke har responderet tilfredsstillende på konventionel behandling såsom topikale kortikosteroider.
English: Erythema was a common skin irritation adverse reaction.
Danish: Erytem er en almindeligt rapporteret bivirkning.
English: In a 24-month dermal carcinogenicity study performed in mice with 0.1% ointment, no skin tumours were observed.
Danish: Man fandt ingen hudtumorer i en 24 måneders undersøgelse af dermal karcinogenicitet på mus hvor man benyttede 0,1% salve.
English: Post-marketing cases of increased tacrolimus blood level have been reported in these conditions.
Danish: Efter markedsføringen er der blevet rapporteret tilfælde med øget tacrolimus-serumkoncentration hos patienter med disse hudsygdomme.
English: Improvement ≥ 90% in Physician's Global Evaluation § lower values = greater improvement
Danish: Bedring ≥ 90% i lægens samlede vurdering § mindre værdier = større positiv effekt
English: There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the study.
Danish: Der var ingen klinisk relevante ændringer i laboratorieværdier eller i puls og blodtryk i nogen af grupperne i løbet af studiet.
English: Before commencing treatment with Protopic ointment, clinical infections at treatment sites should be cleared.
Danish: Før man starter behandling med Protopic salve, skal alle områder med klinisk inficeret atopisk dermatitis være helede.
English: Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment.
Danish: Brændende følelse og kløe forekommer meget almindelig, sædvanligvis af let til moderat intensitet.
English: Global Evaluation § Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck §§ higher values = greater improvement
Danish: Forbedring ≥ 90% i lægens samlede vurdering § Lokal kortikosteroidbehandling = 0,1% hydrocortisonbutyrat på krop og ekstremiteter, 1% hydrocortisonacetat på ansigt og hals.
English: Vehicle Twice weekly (N=75)
Danish: Vehikel To gange ugentlig (N=75)
English: A statistically significant better improvement was shown for once daily and twice daily 0.03% tacrolimus ointment compared to twice daily hydrocortisone acetate ointment (p<0.001 for both).
Danish: En statistisk signifikant øget bedring blev vist for administration en gang om dagen og for administrering af 0,03% tacrolimussalve to gange om dagen i sammenligning med administrering af 1% hydrocortisonacetat-salve (p< 0,001 for begge).
English: White soft paraffin Liquid paraffin Propylene carbonate White beeswax
Danish: Propylencarbonat Hvidt voks
English: • skin tingling
Danish: • prikken i huden
English: Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 or more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by using Protopic 0.03% ointment twice weekly.
Danish: Når moderat til alvorlig atopisk dermatitis er helet eller næsten helet efter op til 6 ugers behandling af et eksemudbrud, og hvis du oplever jævnlige eksemudbrud (dvs. 4 eller flere gange om året), kan det være muligt at forebygge tilbagevenden af eksemudbrud eller at forlænge den tid, du er fri for eksemudbrud, ved at bruge Protopic 0,03% salve to gange ugentlig.
English: Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 or more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by using Protopic 0.1% ointment twice weekly.
Danish: Når moderat til alvorlig atopisk dermatitis er helet eller næsten helet efter op til 6 ugers behandling af et eksemudbrud, og hvis du oplever jævnlige eksemudbrud (dvs. 4 eller flere gange om året), kan det være muligt at forebygge tilbagevenden af eksemudbrud eller at forlænge den tid du er fri for eksemudbrud ved at bruge Protopic 0,1% salve to gange ugentlig.
English: Vehicle Twice weekly (N=73)
Danish: Vehikel To gange ugentlig (N=73)
English: Emollients should not be applied to the same area within 2 hours of applying Protopic ointment.
Danish: Blødgørende cremer bør ikke benyttes på et behandlet hudområde fra 2 timer før til 2 timer efter påsmøring af Protopic salve.
English: Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment.
Danish: Protopic findes i to styrker, Protopic 0,03% salve og Protopic 0,1% salve.
English: Ointment 30 g
Danish: Salve 30 g 60 g