FrancophonIA/ELRC3.0 huggingface dataset:
English: In children, maintenance treatment should be suspended after 12 months, to assess whether the need for continued treatment still exists.
Danish: Hos børn bør vedligeholdelsesbehandling stoppes efter 12 måneder for at afklare, om behandlingen stadig behøves.
English: Protopic ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Danish: Protopic salve er ikke blevet afprøvet for virkning og sikkerhed ved behandling af klinisk inficeret atopisk dermatitis.
English: • If you have swollen lymph nodes at initiation of treatment.
Danish: • hvis du har hævede lymfekirtler ved behandlingens start.
English: If symptoms recur, twice daily treatment with Protopic 0.1% should be restarted.
Danish: Hvis symptomerne vender tilbage, skal behandlingen med Protopic 0,1% to gange om dagen genoptages.
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 hydrocortisongruppen.
English: • If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6) or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).
Danish: - Hvis du er allergisk over for tacrolimus eller et af de øvrige indholdsstoffer i Protopic (angivet i punkt 6) eller over for makrolidantibiotika (f.eks. azithromycin, clarithromycin, erythromycin).
English: Patients who are responding to up to 6 weeks treatment using tacrolimus ointment twice daily (lesions cleared, almost cleared or mildly affected) are suitable for maintenance treatment.
Danish: Patienter, som responderer på op til 6 ugers behandling med tacrolimussalve to gange daglig (helet, næsten helet eller kun mildt afficeret), er egnet til vedligeholdelsesbehandling.
English: Patients were randomised to receive either tacrolimus ointment (0.1% adults; 0.03% children) or vehicle, once a day twice weekly on Mondays and Thursdays.
Danish: Patienterne blev randomiseret til at modtage enten tacrolimussalve ( 0,1% til voksne, 0,03% til børn) eller vehikel, én gang daglig to gange om ugen om mandagen og torsdagen.
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, itraconazol, ketoconazol og diltiazem) til patienter med udbredte og/eller erythrodermiske lidelser ske med forsigtighed.
English: In both adults and children with an average of 50% body surface area treated, systemic exposure (i.e. AUC) of tacrolimus from Protopic 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 Protopic cirka 30-gange mindre end hvad man finder ved orale immunosuppressive doser i nyre- og levertransplanterede patienter.
English: The efficacy and safety of tacrolimus ointment in maintenance treatment of mild to severe atopic dermatitis was assessed in 524 patients in two Phase III multicentre clinical trials of similar design, one in adult patients (≥16 years) and one in paediatric patients (2-15 years).
Danish: Virkning og sikkerhed af tacrolimussalve ved vedligeholdelsesbehandling af mild til svær atopisk dermatitis blev vurderet hos 524 patienter i to fase III multicenter kliniske studier af identisk design, et med voksne patienter (≥ 16 år) og et med pædiatriske patienter (2-15 år).
English: In a photocarcinogenicity study, albino hairless mice were chronically treated with tacrolimus ointment and UV radiation.
Danish: I et fotokarcinogenicitets studie fik hårløse albinomus kronisk behandling med tacrolimussalve og UV bestråling.
English: Patients with atopic dermatitis are predisposed to superficial skin infections.
Danish: Patienter med atopisk dermatitis er prædisponerede for superficielle hudinfektioner.
English: Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous interactions that could affect the metabolism of tacrolimus.
Danish: Da tacrolimus ikke metaboliseres i huden, er der intet potentiale for perkutane interaktioner, der ville kunne påvirke metabolismen af tacrolimus.
English: Protopic ointment should not be used in children aged below 2 years until further data are available.
Danish: Protopic salve bør ikke anvendes til børn under 2 år, før yderligere data er tilgængelige.
English: Overdosage following topical administration is unlikely.
Danish: Overdosering som følge af lokal applikation er usandsynlig.
English: These may include monitoring of vital signs and observation of clinical status.
Danish: Disse kan omfatte måling af puls og blodtryk samt observation af klinisk status.
English: Contents of the pack and other information What Protopic contains
Danish: Pakningsstørrelser og yderligere oplysninger Protopic indeholder:
English: Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopic ointment is not recommended.
Danish: Selvom kliniske data har vist, at den systemiske eksponering er lav ved brug af tacrolimussalve, anbefales det ikke at amme under behandling med Protopic salve.
English: Sensation of warmth, pain, paraesthesia and rash at the site of application were also commonly observed.
Danish: Varmefølelse, smerte, paræstesie og udslæt på applikationsstedet er ligeledes almindeligt forekommende.
English: Treatment with Protopic may be associated with an increased risk of folliculitis and herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption) (see section 4.8).
Danish: Behandling med Protopic kan øge risikoen for follikulitis og infektion med herpes virus (herpes simplex dermatitis [eczema herpeticum], herpes simplex [forkølelsessår], Kaposis varicelliforme eruption) (se pkt.
English: The changes were caused by high systemic exposure of rodents resulting from high transdermal absorption of tacrolimus.
Danish: Forandringerne skyldtes kraftig systemisk eksponering i gnavere på grund af udtalt transdermal absorption af tacrolimus.
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 virkning i studiets forløb.
English: Tacrolimus has also been shown to inhibit the release of inflammatory mediators from skin mast cells, basophils and eosinophils.
Danish: Tacrolimus er også vist at hæmme frigørelse af inflammations mediatorer fra hudmastceller og fra basofile og eosinofile leukocyter.
English: Tacrolimus ointment did not reduce skin thickness and did not cause skin atrophy in animals.
Danish: Tacrolimussalve reducerede ikke hudtykkelsen og gav ikke hudatrofi i dyremodeller.
English: If ingested, general supportive measures may be appropriate.
Danish: Hvis salven indtages peroralt kan almindelige støtteforanstaltninger komme på tale.
English: Following twice-weekly treatment application site infections have been reported in children and adults.
Danish: I forbindelse med behandling to gange ugentligt er infektioner på påsmøringsstedet indberettet for børn og voksne.
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 tacrolimusgruppen.
English: The use of Protopic 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 Protopic på samme tid som andre hudmidler, eller mens du tager kortikosteroider (f.eks. kortison) som kapsler eller tabletter, eller lægemidler, der påvirker immunsystemet, er ikke undersøgt.
English: No adverse events not reported previously were observed in these studies.
Danish: Der blev ikke observeret bivirkninger i dette studie, som ikke tidligere har været rapporteret.
English: Protopic is a white to slightly yellowish ointment.
Danish: Protopic er en hvid, lidt gullig salve.
English: Reduced sperm function was noted in male rats at high subcutaneous doses of tacrolimus.
Danish: Man fandt reduceret spermfunktion i hanrotter ved høje subkutane doser af tacrolimus.
English: Each affected region of the skin should be treated with Protopic until lesions are cleared, almost cleared or mildly affected.
Danish: Hvert afficeret hudområde bør behandles med Protopic, indtil læsionerne er helet, næsten helet eller kun mildt afficeret.
English: • If you have liver failure.
Danish: • hvis du har leversvigt.
English: In the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopic should be considered.
Danish: Hvis man ikke kan finde en klar årsag til lymphadenopatien, eller i tilfælde af akut infektiøs mononucleose bør behandlingen med Protopic seponeres.
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 tacrolimussalve medførte systemisk toksicitet med forandringer i nyrer, bugspytkirtel, øjne og centralnervesystem.
English: 217 days
Danish: 217 dage
English: In case of persistent lymphadenopathy, the aetiology of the lymphadenopathy should be investigated.
Danish: I tilfælde af persisterende lymphadenopati bør man forsøge at klarlægge lymfadenopatiens ætiologi.
English: Formal topical drug interaction studies with tacrolimus ointment have not been conducted.
Danish: Der er ikke udført formelle lokale interaktionsstudier med tacrolimus salve.
English: After 12 months this evaluation should include suspension of Protopic treatment in paediatric patients (see section 4.2).
Danish: Efter 12 måneders behandling bør denne evaluering indbefatte seponering af Protopic-behandlingen hos børn (se pkt.
English: No adverse events previously unreported in shorter duration and/or previous studies were observed in this long-term study.
Danish: Man så i dette langtidsstudie ingen bivirkninger, der ikke var rapporteret ved kortere behandlingstid og/eller tidligere studier.
English: Transplant patients receiving immunosuppressive regimens (e.g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore patients who receive Protopic and who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Danish: Transplanterede patienter, der får immunsuppressiv behandling (f.eks. systemisk tacrolimus) har en øget risiko for at udvikle lymfomer, hvorfor patienter, der behandles med Protopic og udvikler lymphadenopati bør følges nøje for at sikre, at lymphadenopatien helbredes.
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 kardiotoksicitet.
English: Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopic 0.03% ointment, can be used.
Danish: Afhængig af, hvordan dit eksem reagerer, vil lægen afgøre om hyppigheden af påsmøringer kan reduceres eller den svagere salve, Protopic 0,03% salve, kan benyttes.
English: The primary endpoint of this study was the response rate to vaccination, defined as the percentage of patients with a serum bactericidal antibody (SBA) titre ≥ 8 at the week 5 visit.
Danish: Studiets primære endepunkt var responsraten på vaccination, defineret som procentdelen af patienter med en serum baktericid antistof (SBA)-titer ≥ 8 ved besøget i den 5. uge.
English: The primary endpoint was defined as the percentage decrease in mEASI from the baseline to end of treatment.
Danish: Den primære parameter var defineret som den procentvise formindskelse af mEASI fra baseline og indtil afslutning af behandlingen.
English: You may use moisturising creams and lotions during treatment with Protopic but these products should not be used within two hours of applying Protopic.
Danish: Du kan bruge fugtighedscreme og lotion under behandlingen med Protopic, men det må ikke bruges 2 timer før og efter påsmøring af Protopic salve.
English: Both studies showed significant benefit with twice weekly treatment with tacrolimus ointment with regard to the primary and key secondary endpoints over a period of 12 months in a pooled population of patients with mild to severe atopic dermatitis.
Danish: Begge studier viste en signifikant effekt af behandling med tacrolimussalve to gange daglig med hensyn til primære og væsenlige sekundære endepunkter over en periode på 12 måneder i en samlet patientpopulation med mild til alvorlig atopisk dermatitis.
English: Protopic 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years.
Danish: Protopic 0,03% salve er indiceret til voksne, unge og børn fra 2 år.
English: The use of tacrolimus ointment is not recommended in patients with a skin barrier defect, such as Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease.
Danish: Det kan ikke anbefales at anvende tacrolimussalve til patienter med defekt hudbarriere såsom Nethertons syndrom, lamelløs iktyose, generaliseret erytroderma eller kutan graft versus host-sygdom.
English: Systemically available tacrolimus is metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4).
Danish: Systemisk tilgængeligt tacrolimus metaboliseres via hepatisk Cytochrom P450 3A4 (CYP3A4).
English: However, a link to Protopic ointment treatment has not been shown.
Danish: Der er imidlertid ikke vist en sammenhæng med behandling med Protopic salve.
English: If signs of a flare reoccur, twice daily treatment should be re-initiated (see flare treatment section above).
Danish: Hvis der opstår tegn på et eksemudbrud, bør behandling to gange dagligt genoptages (se ”Behandling af eksemudbrud” ovenfor).
English: Care should be taken to avoid contact with eyes and mucous membranes.
Danish: Man skal undgå kontakt med øjne eller slimhinder.
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 tacrolimussalven viste en signifikant reduceret tid indtil udvikling af hudtumorer (planocellulære karcinomer) samt et øget antal tumorer.
English: • If you have an inherited skin barrier disease such as Netherton's syndrome, lamellar ichthyosis (extensive scaling of the skin due to a thickening of the outer layer of the skin), or if you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire skin).
Danish: • hvis du har en arvelig hudbarrieresygdom såsom Nethertons syndrom, lamelløs iktyose (kraftig afskalning af huden på grund af fortykkelse af det øverste hudlag), eller hvis du lider af generaliseret erytrodermi (rødme på grund af vævsirritation og afskalning af huden overalt på kroppen).
English: The primary endpoint was the response rate at month 3 defined as the proportion of patients with at least 60% improvement in the mEASI (modified Eczema Area and Severity Index) between baseline and month 3.
Danish: Den primære parameter var responsraten ved måned 3, defineret som delen af patientgruppen med mindst 60% forbedring i mEASI (modified Eczema Area and Severity Index) fra baseline til måned 3.
English: Hypersensitivity to the active substance, macrolides in general, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, over for makrolider generelt eller over for et eller flere af hjælpestofferne anført i pkt.
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 af reduceret Fc receptor expression på Langerhanske celler og en reduktion af deres hyperstimulerende effekt på T-celler.
English: Protopic contains the active substance tacrolimus, a calcineurin inhibitor.
Danish: Protopic indeholder den aktive substans tacrolimus, som er en calcinurinhæmmer.
English: If a disease exacerbation occurred, patients were treated with open-label tacrolimus ointment twice daily for a maximum of 6 weeks until the IGA score returned to ≤2.
Danish: Hvis der opstod et eksemudbrud, blev patienterne behandlet åbent med tacrolimussalve to gange daglig i maksimalt 6 uger, indtil IGA-score igen var ≤ 2.
English: However, a link to Protopic ointment treatment has not been confirmed or refuted on the available evidence so far.
Danish: Indtil videre er en sammenhæng med behandlingen med Protopic salve imidlertid hverken blevet bekræftet eller modbevist.
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: The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period.
Danish: Den primære parameter var area-under-the curve (AUC) af mEASI som procent af baseline mean værdien i behandlingsperioden.
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 immunsuppression efter systemisk administration af calcinurinhæmmere associeret med en øget risiko for udvikling af lymfomer og hudmaligniteter.
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 tacrolimussalve eller af salvegrundlag til rotter, kaniner og minigrise medførte lettere dermale ændringer så som erytem, ødem og papler.
English: • If you notice any change to the appearance of your skin, please inform your physician.
Danish: • hvis du bemærker nogen ændring i din huds udseende.
English: You may be told by your doctor to use Protopic ointment twice weekly once your atopic dermatitis has cleared or almost cleared (Protopic 0.03% for children and Protopic 0.1% for adults).
Danish: Din læge kan fortælle dig, at du skal bruge Protopic salve to gange ugentlig, når dit eksem er helet eller næsten helet (Protopic 0,03% til børn og Protopic 0,1% til voksne).
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 Protopic ointment (see section 5.3).
Danish: Under behandling med Protopic salve skal hudens eksponering for sollys minimeres og ultraviolet (UV) lys fra et solarium samt behandling med UVB eller UVA i kombination med psoralener (PUVA) undgås (se pkt.
English: Median number of DEs requiring substantial intervention adjusted for time at risk (% of patients without DE requiring substantial intervention) Median time to first DE requiring substantial intervention
Danish: Median af antallet af eksemudbrud som kræver betydelig intervention justeret for 'time at risk' (% af patienter uden eksemudbrud krævende betydelig intervention) Median af tiden til første eksemudbrud krævende betydelig intervention
English: Do not use this medicine after the expiry date which is stated on the tube and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Tacrolimus ointment does not affect collagen synthesis in humans.
Danish: Tacrolimussalve har ingen effekt på kollagensyntesen hos mennesker.
English: Children • Protopic 0.1 % ointment is not approved for children younger than 16 years of age.
Danish: • Protopic 0,1% salve er ikke godkendt til børn under 16 år.
English: In the presence of these infections, the balance of risks and benefits associated with Protopic use should be evaluated.
Danish: Man bør tage disse infektioner i betragtning, når man vurderer risici og fordele ved Protopic.
English: Apply Protopic 0.03 % ointment twice a day for up to three weeks, once in the morning and once in the evening.
Danish: Påsmør Protopic 0,03% salve 2 gange om dagen i op til 3 uger, en gang om morgenen og en gang om aftenen.
English: Rosacea (facial redness), rosacea-like dermatitis, lentigo (presence of flat brown spots on the skin), oedema at the application site and herpes eye infections have been reported during post-marketing experience.
Danish: Rosacea (rødme af huden i ansigtet), rosacea-lignende eksem, lentigo (brune pletter på huden), ødem (hævelse) ved applikationsstedet og herpes øjeninfektioner er blevet indberettet, efter præparatet er kommet på markedet.
English: • feeling of warmth
Danish: • varmefølelse
English: In the same study an increased incidence of lymphoma was detected in association with high systemic exposure.
Danish: I denne undersøgelse fandt man en øget forekomst af lymfomer på grund af den høje systemiske eksponering.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: What you need to know before you use Protopic Do not use Protopic
Danish: Det skal du vide, før du begynder at bruge Protopic Brug ikke Protopic
English: Systemically available tacrolimus is extensively metabolised in the liver via CYP3A4.
Danish: Systemisk tilgængeligt tacrolimus er extensivt metaboliseret i leveren via CYP3A4.
English: Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation)
Danish: Paræstesi og dysæstesi (hyperæstesi, brændende følelse)
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 tacrolimussalve (0,03 - 0,1%), og spædbørn fra 5 måneders alderen behandlet med tacrolimussalve (0,03%), havde blodkoncentrationer < 1,0 ng/ml.
English: In one arm patients received Protopic 0.03% ointment (n=121) twice a day for 3 weeks and thereafter once a day until clearance.
Danish: I den ene arm fik patienterne Protopic 0,03% salve (n=121) to gange dagligt i 3 uger og derefter en gang dagligt indtil opheling.
English: Tacrolimus is extensively metabolised in the liver and although blood concentrations are low following topical therapy, the ointment should be used with caution in patients with hepatic failure (see section 5.2).
Danish: Tacrolimus metaboliseres i udstrakt grad i leveren, og selv om blodkoncentrationen er lav i forbindelse med lokalbehandling, skal der udvises forsigtighed ved brug af salven til patienter med leverinsufficiens (se pkt.