FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Protopy or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).
Danish: Hvis De er allergisk (overfølsom) over for tacrolimus eller et af de øvrige indholdsstoffer i Protopy eller til makrolide antibiotika (f.eks. azithromycin, clarithromycin, erythromycin).
English: Don't use Protopy if you are pregnant or breast-feeding.
Danish: Brug ikke Protopy, hvis De er gravid eller ammer.
English: A potential interaction between vaccination and application of Protopy ointment has not been investigated.
Danish: Man har ikke undersøgt den mulige interaktion mellem vaccination og brug af Protopy salve.
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 tacrolimus salve.
English: Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet ved systemisk administrering (se pkt.
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 tacrolimus salve, er den kraftige plasmabinding af tacrolimus (> 98,8%) næppe klinisk relevant.
English: If you have infected lesions.
Danish: Hvis hudlæsionerne er inficerede.
English: Avoid contact with the eyes or mucous membranes (inside of your nose or mouth).
Danish: Undgå kontakt med øjne eller slimhinder (i munden og i næsen).
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 immunosuppressive
English: In animals, tacrolimus ointment suppressed inflammatory reactions in experimental and spontaneous dermatitis models that resemble human atopic dermatitis.
Danish: I dyr undertrykker tacrolimus salve inflammatoriske reaktioner i eksperimentelle og spontane dermatitismodeller, der ligner den humane atopiske dermatitis.
English: Protopy should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Danish: Protopy skal initieres af læger med erfaring i diagnosticering og behandling af atopisk dermatitis.
English: Treatment should be started twice a day for up to three weeks.
Danish: Behandlingen bør begynde med applikation to gange om dagen i indtil 3 uger.
English: Patients with atopic dermatitis treated with Protopy have not been found to have significant systemic tacrolimus levels.
Danish: Patienter med atopisk dermatit behandlet med Protopy er ikke set at have signifikante systemiske tacrolimus niveauer.
English: Patients with atopic dermatitis are predisposed to superficial skin infections.
Danish: Patienter med atopisk dermatitis er prædisponerede for superficielle hud infektioner.
English: Before applying Protopy after a bath or shower, be sure your skin is completely dry.
Danish: Før påsmøring af Protopy salve efter et bad eller brusebad skal man være helt sikker på, at huden er fuldstændig tør.
English: If you spend time outdoors after applying Protopy, use a sunscreen and wear loose fitting clothing that protects the skin from the sun.
Danish: Hvis De er udendørs efter at have påsmurt Protopy, brug da et solbeskyttelsesmiddel og tag løst tøj på, der beskytter huden mod solen.
English: Avoid using the ointment inside your nose or mouth or in your eyes.
Danish: Undgå at påsmøre salven i næsen, munden eller i øjnene.
English: The use of Protopy ointment under occlusion has not been studied in patients.
Danish: Brug af Protopy salve under occlusion er ikke undersøgt på patienter.
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
English: Protopy is not recommended for use in children below age of 2 years until further data are available.
Danish: Protopy er ikke anbefalet til brug hos børn under 2 år før yderligere data er tilgængelige.
English: The majority of these cases 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: Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
Danish: Systemiske carcinogenicitets undersøgelser i mus (18 måneder) og rotter (24 måneder) viste ingen tegn på tumorogent potentiale.
English: Protopy may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees.
Danish: Protopy kan anvendes på de fleste områder af kroppen, også i ansigtet og på halsen, og på bøjefurene
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: Respons raten i 0,1% tacrolimus gruppen (71,6%) var signifikant højere end den i gruppen med lokal kortikosteroid behandling (50,8%, p< 0,001; Tabel 1).
English: Taking or using other medicines and cosmetics Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Indtagelse og anvendelse af anden medicin og af kosmetik Hvis De tager eller for nylig har taget andre lægemidler, bør De oplyse Deres læge eller apotek herom, også hvis der er tale om ikke-receptpligtige lægemidler.
English: Protopy ointment is not approved for children younger than 2 years of age.
Danish: Protopy salve er ikke godkendt til børn under 2 år.
English: If you have an inherited skin barrier disease such as Netherton's syndrome or if you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire skin).
Danish: Hvis De har en arvelig hudbarrierelidelse som f.eks. Netherton's syndrom eller hvis De lider af generaliseret erythrodermi (inflammatorisk rødmen og skoldning over hele kroppen).
English: However, the possibility of interactions cannot be ruled out and the concomitant systemic administration of known CYP3A4 inhibitors (e.g. erythromycin, itraconazole, ketoconazole and diltiazem) in patients with widespread and/or erythrodermic disease should be done with caution.
Danish: Da muligheden for interaktioner imidlertid ikke helt kan udelukkes, bør samtidig administrering af kendte CYP3A4 inhibitorer (f.eks. erythromycin, itaconazol, ketoconazol og diltiazem) til patienter med udbredte og/eller erythrodermiske lidelser ske
English: Also speak to your doctor before using Protopy if you have any skin malignancies (tumours) or if you have a weakened immune system (immuno-compromised) whatever the cause.
Danish: Tal også med lægen før De bruger Protopy hvis De har hudmaligniteter (tumorer) eller hvis De har svækket immunforsvar uanset årsagen.
English: The use of Protopy at the same time as other preparations to be used on the skin or while taking oral corticosteroids (e.g. cortisone) or medicines which affect the immune system has not been studied.
Danish: Brugen af Protopy på samme tid som andre hudmidler, eller mens De tager kortikosteroider (f.eks. kortison) som kapsler eller tabletter, eller lægemidler, der påvirker immunsystemet, er ikke undersøgt.
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
English: In both adults and children with an average of 50% body surface area treated, systemic exposure (i.e. AUC) of tacrolimus from Protopy is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
Danish: Hos både voksne og børn, der får behandlet 50% af kroppens overflade, er den systemiske eskponering (dvs AUC) af tacrolimus fra Protopy cirka 30-gange mindre end hvad man finder ved orale immunosuppressive doser i nyre- og levertransplanterede patienter.
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% tacrolimus salve i et åbent langtidsstudie af tolerabilitet med 300 patienter der blev behandlet i mindst 3 år og 79 patienter der blev behandlet i mindst 42 måneder.
English: The use of Protopy ointment in patients with genetic epidermal barrier defects such as Netherton's syndrome is not recommended due to the potential for permanently increased systemic absorption of tacrolimus.
Danish: Det kan ikke anbefales at benytte Protopy salve til patienter med genetisk epidermale barrieredefekter som Netherton's syndrome på grund af potentialet for permanent øget systemisk absorption af tacrolimus.
English: Pruritus decreased over time in the tacrolimus groups but not in the hydrocortisone group.
Danish: Kløe formindskedes over tid i tacrolimusgruppen, men ikke i hydrokortison gruppen.
English: Reduced sperm function was noted in male rats at high subcutaneous doses of tacrolimus.
Danish: Man fandt reduceret sperm funktion i hanrotter ved høje subkutane doser af tacrolimus.
English: Care should be exercised if applying Protopy 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 Protopy anvendes til patienter som skal have et stort hudareal behandlet over en længere tidsperiode, især til børn (se pkt.
English: If you are prescribed light therapy, inform your doctor that you are using Protopy as it is not recommended to use Protopy and light therapy at the same time.
Danish: Hvis De får ordineret lysbehandling skal De oplyse lægen om, at De bruger Protopy og at det frarådes at bruge Protopy og få lysbehandling på samme tid.
English: Approximately half of the patients who use Protopy have some type of skin irritation where they have applied the ointment.
Danish: Omkring halvdelen af de patienter, der bruger Protopy føler en eller anden form for hudirritation, hvor salven er påsmurt.
English: Do not use Protopy after the expiry date which is stated on the tube and carton after EXP.
Danish: Anvend ikke efter udløbsdatoen, som er angivet på tuben og æsken efter EXP. Udløbsdatoen referer til
English: Transplant patients receiving immunosuppressive regimens (e.g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore patients who receive Protopy and who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Danish: Transplanterede patienter, der får immunosuppressiv behandling (f.eks. systemisk tacrolimus) har en øget risiko for at udvikle lymfomer, hvorfor patienter, der behandles med Protopy og udvikler lymphadenopati bør følges nøje for at sikre, at lymphadenopatien helbredes.
English: Vaccinations should not be given during treatment and for a certain time after treatment with Protopy.
Danish: Man bør ikke vaccineres under behandling med Protopy og i et vist tidsrum efter behandlingen.
English: In a photocarcinogenicity study, albino hairless mice were chronically treated with tacrolimus ointment and UV radiation.
Danish: I et fotocarcinogenicitets studie fik hårløse albinomus kronisk behandling med tacrolimus salve og UV bestråling.
English: Tacrolimus ointment did not reduce skin thickness and did not cause skin atrophy in animals.
Danish: Tacrolimus salve reducerede ikke hudtykkelsen og gav ikke hudatrofi i dyremodeller.
English: For live attenuated vaccinations (e.g. measles, mumps, rubella or oral polio) the waiting time is 28 days, for inactivated vaccines (e.g. tetanus, diphtheria, pertussis or influenza) 14 days.
Danish: For levende afsvækkede vacciner (f.eks. mæslinger, fåresyge, røde hunde eller polio vaccine indtaget gennem munden) er tidsrummet 28 dage, for inaktive vacciner (f.eks. stivkrampe, difteritis, kighoste eller influenza) er tidsrummet 14 dage.
English: In addition, there was no evidence of loss of efficacy throughout the duration of the clinical trial.
Danish: Der var desuden ingen tegn på tab af effekt i studiets forløb.
English: Other common (> 1%) side effects are redness, feeling of warmth, pain, increased skin sensitivity (especially to hot and cold), skin tingling, rash, folliculitis (inflamed or infected hair follicles) and herpes viral infections (e.g. cold sores, generalised herpes simplex infections).
Danish: Andre almindelige (> 1%) bivirkninger er rødmen, varmefølelse, smerte, øget hudfølsomhed (specielt for kulde og varme), prikken i huden, hududslæt, folliculitis (inflammerede eller inficerede hårsække) og herpes virus infektioner (f.eks. forkølelsessår, udbredte herpes simplex infektioner).
English: Skin burning, herpes simplex, alcohol intolerance (facial flushing or skin sensitivity after alcohol intake), skin tingling, hyperaesthesia, acne and fungal dermatitis occurred more often in the tacrolimus treatment group.
Danish: Brændende fornemmelse i huden, herpes simplex, alkoholintolerance (facial flushing eller øget hudfølsomhed efter alkoholindtagelse), prikken i huden, hyperæstesi, acne og fungal dermatitis forekom dog hyppigere i tacrolimus gruppen.
English: A very small number of people who have used Protopy ointment have had malignancies (for example, skin or lymphoma).
Danish: Ganske få personer, som har anvendt Protopy salve, har haft maligniteter (f.eks. hud eller lymfom).
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 hudmidler, bør patienten vaske hænder efter påsmøring, med mindre man også ønsker at behandle hænderne.
English: Avoid exposing the skin to long periods of sunlight or artificial sunlight such as tanning beds.
Danish: Undgå at udsætte huden for langvarig solbestråling eller kunstig bestråling som f.eks. solarielys.
English: Most atopic dermatitis patients (adults and children) treated with single or repeated application of tacrolimus ointment (0.03 - 0.1%), and infants from age of 5 months treated with tacrolimus ointment (0.03%) had blood concentrations < 1.0 ng/ml.
Danish: Flertallet af de patienter med atopisk dermatitis (voksne og børn), der er blevet behandlet med en enkelt eller med gentagen applikation af tacrolimus salve (0,03 - 0,1%), og spædbørn fra 5 måneders alderen behandlet med tacrolimus salve (0,03%), havde blodkoncentrationer < 1,0 ng/ml.
English: Hypersensitivity to macrolides in general, to tacrolimus or to any of the excipients.
Danish: Overfølsomhed over for macrolider generelt, over for tacrolimus eller over for et eller flere af
English: In case of live attenuated vaccination, this period should be extended to 28 days or the use of alternative vaccines should be considered.
Danish: Ved brug af levende, afsvækkede vacciner bør perioden øges til 28 dage eller man må
English: As clinical efficacy studies were performed with abrupt cessation of treatment, no information is available on whether tapering of the dosage would reduce recurrence rate.
Danish: Da man har benyttet afbrudte behandlingsperioder i de kliniske afprøvninger, ved man ikke om aftrapning af doseringen vil kunne reducere hyppigheden af recidiver.
English: Talk to your doctor before using Protopy.
Danish: Tal med lægen før De begynder at bruge Protopy.
English: If your lymph nodes become swollen during treatment with Protopy, consult your doctor.
Danish: Hvis Deres lymfekirtler bliver hævede under behandling med Protopy skal De tale med lægen.
English: In patients with atopic dermatitis, improvement of skin lesions during treatment with tacrolimus ointment was associated with reduced Fc receptor expression on Langerhans cells and a reduction of their hyperstimulatory activity towards T cells.
Danish: Hos patienter med atopisk dermatitis var bedringen af hudlæsioner under salvebehandling med tacrolimus ledsaget at reduceret Fc receptor expression på Langerhanske celler og en reduktion af deres hyperstimulerende effekt på T-celler.
English: Long-term topical treatment of rats with tacrolimus led to systemic toxicity including alterations of kidneys, pancreas, eyes and nervous system.
Danish: Langtids lokalbehandling af rotter med tacrolimus salve medførte systemisk toksicitet med forandringer i nyrer, bugspytkirtel, øjne og centralnervesystem.
English: Repeated topical administration of tacrolimus ointment or the ointment vehicle to rats, rabbits and micropigs was associated with slight dermal changes such as erythema, oedema and papules.
Danish: Gentagen lokal administrering af enten tacrolimus salve eller af salvegrundlag til rotter, kaniner og minigrise medførte lettere dermale ændringer så som erythem, ødem og papler.
English: Before receiving a vaccination tell your doctor that you are using Protopy (see Section “Take special care with Protopy”).
Danish: Før en vaccination skal lægen informeres om brug af Protopy (se afsnittet ”Vær særlig forsigtig med at
English: Lymphadenopathy present at initiation of therapy should be investigated and kept under review.
Danish: Lymphadenopati som er kendt ved initiering af behandlingen skal undersøges og holdes under observation.
English: Herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption)
Danish: Herpes virus infektioner (herpes simplex dermatitis [eczema herpeticum], herpes simplex [forkølelsessår], Kaposi's varicelliforme eruption)
English: Animals treated with tacrolimus ointment showed a statistically significant reduction in time to skin tumour (squamous cell carcinoma) development and an increase in the number of tumours.
Danish: Dyr, der fik behandling med tacrolimus salven viste en signifikant reduceret tid indtil udvikling af hudtumorer (planocellulære carcinomer) samt et øget antal tumorer.
English: The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax and hard paraffin.
Danish: De øvrige indholdsstoffer er hvid vaselin, paraffinolie, propylenkarbonat, hvidt voks og paraffin.
English: Do not try to induce vomiting.
Danish: De skal ikke forsøge at fremkalde en opkastning.
English: In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies.
Danish: Hos transplantationspatienter er langvarig systemisk og intens immunosuppression efter systemisk administration af calcinurinhæmmere associeret med en øget risiko for udvikling af lymfomer og hudmaligniteter.
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 De glemmer at påsmøre salven på det fastsatte tidspunkt, påsmør salve straks De kommer i tanke
English: You may use moisturising creams and lotions during treatment with Protopy but these products should not be used within two hours of applying Protopy.
Danish: De kan bruge fugtighedscreme og lotion under behandlingen med Protopy, men det må ikke bruges 2 timer før og efter påsmøring af Protopy salve.
English: Protopy contains the active substance tacrolimus, a calcineurin inhibitor.
Danish: Protopy indeholder den aktive substans tacrolimus, som er en calcinurinhæmmer.
English: Protopy ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Danish: Protopy salve er ikke blevet afprøvet for effekt og tolerabilitet ved behandling af klinisk inficeret atopisk dermatitis.
English: Exposure of the skin to sunlight should be minimised and the use of ultraviolet (UV) light from a solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use of Protopy ointment (see section 5.3).
Danish: Så længe hudområder behandles med Protopy salve skal hudens eksponering for sollys minimeres og brug af ultraviolet (UV) lys fra et solarium, behandling med UVB eller UVA i kombination med psoralener (PUVA) undgås (se pkt.
English: Usually, treatment is started with Protopy 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 Protopy 0,1% salve 2 gange om dagen, en gang om morgenen og en gang om aftenen, indtil eksemen er forsvundet.
English: Protopy ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes.
Danish: Protopy salve kan benyttes overalt på kroppen, inklusive ansigt, hals og extremiteternes flexorsider, men ikke på slimhinder.
English: Hydrocortisone acetate 1% (N=185)
Danish: Hydrokortison acetat 1% (N=185)
English: Since commercial availability a very small number of people who have used Protopy ointment have had malignancies (for example, skin or lymphoma).
Danish: Efter markedsføring har et meget lille antal personer, som har brugt Protopy salve, haft maligniteter (f.eks. hud eller lymfom).
English: In the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopy should be considered.
Danish: Hvis man ikke kan finde en klar årsag til lymphadenopatien, eller i tilfælde af akut infektiøs mononucleose bør behandlingen med Protopy seponeres.
English: If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible.
Danish: Hvis De ved et uheld kommer til at indage noget salve Hvis De ved en fejltagelse er kommet til at indtage salven, skal De hurtigst muligt kontakte Deres læge eller apoteket.
English: Treatment with Protopy may be associated with an increased risk of herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption).
Danish: Behandling med Protopy kan øge risikoen for infektion med herpes virus (herpes simplex dermatitis [eczema herpeticum], herpes simplex [forkølelsessår], Kaposi's varicelliforme eruption).
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 tacrolimus salve, 0,03% og 0,1% har signifikant bedre effekt (p<0,001 for begge) end 1% hydrokortison acetat salve (Tabel 2).
English: Protopy ointment should not be applied under occlusion (see section 4.4).
Danish: Protopy salve må ikke benyttes under occlusion (se pkt.
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 hydrokortison gruppen.
English: Rabbits were shown to be especially sensitive to intravenous administration of tacrolimus, reversible cardiotoxic effects being observed.
Danish: Kaniner er specielt følsomme for tacrolimus administreret intravenøst, idet man ser reversibel
English: Do not apply the ointment to infected lesions.
Danish: Smør ikke salven på inficerede hudlæsioner.
English: Generally, improvement is seen within one week of starting treatment.
Danish: Dette svinder sædvanligvis i løbet af en uge efter behandlingens start.