FrancophonIA/ELRC3.0 huggingface dataset:
English: All edible tissues, including injection sites, were sampled on days 19, 40, 61, 89, and 103 after treatment and analysed using an SPE-LC-MS/MS method of analysis, validated in line with current requirements.
Danish: Prøver på alle spiselige væv, herunder injektionsstedet, blev indsamlet på dag 19, 40, 61, 89 og 103 efter behandling og analyseret iht.
English: • The tissue-specific withdrawal period determined from Study 1 for liver was 28 days longer than that for injection sites, which leaves a suitably long time for any additional injection site residues to deplete before the 107-day withdrawal period is complete.
Danish: • Den vævsspecifikke tilbageholdelsestid, der er anført i studie 1 (levervæv), er 28 dage længere end tilbageholdelsestiden for injektionsstedet, hvilket giver tilstrækkelig tid til, at eventuelle yderligere restkoncentrationer ved injektionsstedet kan nå at blive nedbrudt, før tilbageholdelsestiden på 107 dage er gået.
English: The available data demonstrate that the liver is the withdrawal period determining tissue and that the rate of elimination from edible tissues would not be influenced by the rate of absorption from the injection site and thereby impacted by product formulation.
Danish: De tilgængelige data viser, at det er leveren, der er det afgørende væv for fastsættelse af tilbageholdelsestiden, og at eliminationshastigheden fra spiselige væv ikke påvirkes af absorptionshastigheden fra injektionsstedet og dermed af produktets formulering.
English: The concentration of closantel residues in the core injection site samples were below the MRL at 29 days after administration.
Danish: Restkoncentrationerne af closantel i de centrale vævsprøver fra injektionsstedet lå under MRLværdierne 29 dage efter administration.
English: Not authorised for use in ewes producing milk for human consumption including during the dry period.
Danish: Må ikke anvendes hos hunfår, der producerer mælk bestemt til konsum (heller ikke i goldperioden).
English: A risk has been identified regarding the length of the authorised withdrawal periods for sheep (meat and offal), which, for some products, may be insufficient to allow residues of closantel to fall below the authorised MRLs in all edible tissues by the end of the withdrawal period, thereby posing a risk to consumers of meat and offal from sheep treated with these products.
Danish: For nogle produkters vedkommende kan tilbageholdelsestiden være utilstrækkelig til, at restkoncentrationer af closantel kan falde til under de godkendte MRL-værdier i alle spiselige væv inden udgangen af tilbageholdelsestiden, hvilket udgør en risiko for forbrugere af kød og indmad fra får, der er behandlet med disse produkter.
English: It has been shown that, in general, the higher the viscosity of the product, the slower the rate of absorption from the injection site.
Danish: Det er påvist, at jo højere produktets viskositet er, desto langsommere er absorptionshastigheden fra injektionsstedet generelt.
English: The product was administered via subcutaneous injection to sheep at the single recommended dose of 5 mg closantel per kg body weight.
Danish: Produktet blev administreret ved subkutan injektion hos får i den anbefalede enkeltdosis på 5 mg closantel pr. kg kropsvægt.
English: Most (90%) of a dose of closantel is excreted unchanged in the bile/faeces after intramuscular administration, but only 10% within 48 hours, after which the rate slows further so that 1 - 2% of the dose is eliminated each day.
Danish: Kun 10 % udskilles imidlertid inden for 48 timer, hvorefter hastigheden daler yderligere, idet 1-2 % af dosen elimineres hver dag.
English: As data were collected for injection sites, only, in Study 2, it could have been possible to combine or compare data from studies 1 and 2 for depletion from this tissue, only.
Danish: Da der i studie 2 blev indsamlet data for injektionsstedet alene, kunne man have kombineret eller sammenlignet data fra studie 1 og studie 2, hvad angår nedbrydningsdata for injektionsstedet alene.
English: the CVMP has recommended variations of the marketing authorisations for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
Danish: CVMP anbefaler ændring af markedsføringstilladelserne for veterinærlægemidler, der indeholder 50 mg closantel pr. ml (som eneste aktive stof), og som fås som injektionsvæske, opløsning, til subkutan anvendelse hos får (se bilag I), herunder ændring af produktresumé, etikettering og indlægsseddel i overensstemmelse med de anbefalede ændringer i produktinformationen, jf. bilag III.
English: Marketing authorisation holder
Danish: Indehaver af markedsføringstilladels
English: It is slowly released from plasma and very slowly metabolised, and is therefore retained in the circulation for a long time; the plasma elimination half-life in sheep is 22.7 days.
Danish: Det frigives langsomt fra plasma og metaboliseres meget langsomt og bliver derfor længe i kredsløbet.
English: However, based on the data assessed during this procedure, it is possible to make a recommendation to have a 107-day withdrawal period for sheep (meat and offal) for the concerned products containing 50 mg closantel per ml (as a single active substance) presented as a solution for injection for subcutaneous use in sheep.
Danish: Baseret på de data, der er vurderet under denne procedure, kan der imidlertid gives en anbefaling om at have en tilbageholdelsestid på 107 dage for får (kød og indmad), hvad angår de omhandlede produkter, der indeholder 50 mg closantel pr. ml (som eneste aktive stof) og fås som injektionsvæske, opløsning, til subkutan anvendelse hos får.
English: • Although there is some uncertainty as to how the differences in formulation would affect the rate of depletion from the injection sites, the injection volumes used in Study 1 were considered to be reasonable worst case due to the weights of the animals used and the mg/kg, rather than mg/animal, dosing regimen, when compared to the recommended weights of animals in VICH GL 482.
Danish: • Selvom der er en vis usikkerhed om, hvordan formuleringsforskelle kan indvirke på nedbrydningshastigheden fra injektionsstedet, vurderes det injektionsvolumen, der er anvendt i studie 1, i rimelig grad at svare til worst case, da man med hensyn til doseringsregime anvender dyrenes vægt (mg/kg og ikke mg/dyr), jf. anbefalingerne vedrørende dyrenes vægt i VICH GL 48retningslinjen2.
English: It has been noted that there are different approved withdrawal periods for sheep (meat and offal) for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solution for injection for subcutaneous use in sheep across the EU, i.e., between 28 days and 107 days.
Danish: Det bemærkes, at der er forskellige godkendte tilbageholdelsestider for får (kød og indmad), hvad angår veterinærlægemidler, der indeholder 50 mg closantel pr. ml (som eneste aktive stof), og som fås som injektionsvæske, opløsning, til subkutan anvendelse hos får i hele EU, nemlig mellem 28 dage og 107 dage.
English: • Although there is some uncertainty as to how the differences in formulation would affect the rate of depletion from the injection sites, the injection volumes used in Study 1 were considered to be reasonable worst case, due to the weights of the animals used, and the mg/kg dosing regimen, when compared to the recommended weights of animals in VICH GL 48.
Danish: • Selvom der er en vis usikkerhed om, hvordan formuleringsforskelle kan indvirke på nedbrydningshastigheden fra injektionsstedet, vurderes det injektionsvolumen, der er anvendt i studie 1, i rimelig grad at svare til worst case, da man med hensyn til doseringsregime anvender dyrenes vægt (mg/kg), jf. anbefalingerne vedrørende dyrenes vægt i VICH GL 48-retningslinjen.
English: A GLP-compliant residue depletion study in sheep was submitted, conducted with the veterinary medicinal product ‘Flukiver 5%', a product containing 50 mg closantel per ml.
Danish: Der blev fremlagt et GLP-studie af nedbrydningen af restkoncentrationer hos får efter administration af veterinærlægemidlet Flukiver 5%, et produkt, der indeholder 50 mg closantel pr. ml.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af veterinærlægemidler, der indeholder 50 mg closantel pr. ml (som eneste aktive stof), og som fås som injektionsvæske, opløsning, til subkutan anvendelse hos får (se bilag I)
English: The CVMP was requested to review all available residue depletion data for the veterinary medicinal products containing 50 mg closantel per ml (as a single active substance), presented as a solution for injection for subcutaneous use in sheep and recommend withdrawal periods for meat and offal derived from treated sheep.
Danish: CVMP blev bedt om at gennemgå alle tilgængelige data om nedbrydning af restkoncentrationer for veterinærlægemidler, der indeholder 50 mg closantel pr. ml (som eneste aktive stof), og som fås som en injektionsvæske, opløsning, til subkutan anvendelse hos får, og anbefale tilbageholdelsestider for kød og indmad fra behandlede får.
English: Formulation differences may make a difference to how the active substance is absorbed from the injection site, and also, therefore, the overall residues depletion pattern.
Danish: Forskelle i formuleringerne kan betyde, at det er forskelligt, hvordan det aktive stof absorberes fra injektionsstedet, og dermed hvordan det generelle mønster for nedbrydning af restkoncentrationer er. Der blev ikke fremlagt data om nedbrydning af restkoncentrationer for de to sidstnævnte produkter.
English: A GLP-compliant residue depletion study in sheep was submitted, conducted with the veterinary medicinal product ‘Endoex Solucion Injectable', a product containing 50 mg closantel per ml.
Danish: Der blev fremlagt et GLP-studie af nedbrydningen af restkoncentrationer hos får efter administration af veterinærlægemidlet "Endoex Solucion Injectable", der indeholder 50 mg closantel pr. ml.
English: As a result, a withdrawal period of 107 days was determined, using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1.
Danish: "alternative" metode i overensstemmelse med CVMP's vejledning i metoder til harmonisering af tilbageholdelsestider (EMEA/CVMP/036/95)1.
English: The specified pH of the products used in studies 1 and 2 were in the same range; the effect of pH to explain any differences can thus be ruled out.
Danish: De specificerede pH-værdier for de produkter, der blev anvendt i studie 1 og 2, lå inden for samme interval.
English: • with regard to the need for a maximum injection volume to be recommended in case of any difference in depletion on injection site residues, the CVMP does not consider it necessary to restrict the use of these products in this way.
Danish: • CVMP mener ikke, at det er nødvendigt at indføre begrænsninger og anbefale et maksimalt injektionsvolumen for at tage hensyn til forskelle i nedbrydningen af restkoncentrationer ved injektionsstedet.
English: The different quantities included may lead to the products having different viscosities, resulting in different rates of absorption of closantel from the injection site; however, this parameter is not considered to affect the elimination rate from the edible tissues, other than at the injection site itself.
Danish: Disse forskellige mængder kan betyde, at produkterne har forskellig viskositet og dermed forskellig hastighed for absorption af closantel fra injektionsstedet.
English: 1 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link less sensitive, at 500 µg/kg.
Danish: 1 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link markedsføringstilladelse fremlagde rapporter med en beskrivelse af valideringen af de anvendte analysemetoder, og ydeevnekarakteristikaene var overvejende beskrevet i overensstemmelse med gældende standarder.
English: Santiola 50 mg/ml Solution for Injection for Cattle and Sheep sheep sheep: subcutaneous
Danish: Santiola 50 mg/ml Solution for Injection for Cattle and Sheep får
English: Both marketing authorisation holders provided reports detailing the validation of the analytical method used, and the performance characteristics were mostly described in accordance with current standards.
Danish: en HPLC-FD-analysemetode, der var valideret i overensstemmelse med gældende krav.
English: powder: 15 mg 1 vial
Danish: Pulver: 15 mg 1 Hætteglas
English: EU/1/00/140/001 Visudyne
Danish: EU/1/00/140/001 Visudyne 15 mg Pulver til infusionsvæske, opløsning
English: Immediate packaging
Danish: Intravenøs anvendelse
English: This summary was last updated in 09-2007
Danish: Dette sammendrag blev sidst opdateret 09-2007.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Protopy to Astellas Pharma GmbH on 28 February 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Protopy til Astellas Pharma GmbH den 28. februar 2002.
English: Another study has also looked at the use of Protopy for up to 4 years in about 800 patients.
Danish: I endnu en undersøgelse blev Protopy anvendt i op til 4 år hos ca. 800 patienter.
English: Other information about Protopy:
Danish: Andre oplysninger om Protopy:
English: Protopy should not be used in children under 2 years of age.
Danish: Protopy bør ikke anvendes til børn under 2 år.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger på grundlag af CHMP's anbefalinger, kan du læse den faglige drøftelse (der ligeledes er en del af EPAR).
English: In the longer study, Protopy could be used repeatedly without losing its effectiveness.
Danish: I den længstvarende undersøgelse kunne Protopy anvendes gentagne gange uden at miste sin virkning.
English: Protopy is a white to slightly yellowish ointment that contains either 0.1% or 0.03% of the active ingredient tacrolimus.
Danish: Protopy er en hvid til let gullig salve, der indeholder enten 0,1 % eller 0,03 % af det aktive stof tacrolimus.
English: Treatment should be started as twice a day for up to three weeks.
Danish: Ved indledning af behandlingen gives lægemidlet to gange dagligt i op til tre uger.
English: The safety and effectiveness of Protopy has been studied in more than 13,500 patients treated with tacrolimus ointment in clinical trials.
Danish: Sikkerheden og virkningen af Protopy er undersøgt hos over 13 500 patienter, der blev behandlet med tacrolimus salve i kliniske undersøgelser.
English: Tacrolimus has been used since the mid-1990's to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ).
Danish: Tacrolimus er siden midten af 1990'erne blevet anvendt til at mindske afstødningen hos transplantationspatienter (når immunsystemet angriber det transplanterede organ).
English: The most common side effects (seen in more than 1 patient in 10) are burning sensation and itching at the application site.
Danish: De hyppigste bivirkninger (som ses hos flere end 1 ud af 10 patienter) er en brændende fornemmelse og kløe på påføringsstedet.
English: Each affected area is treated with Protopy until the skin is clear and then treatment should be stopped.
Danish: Hvert af de berørte områder behandles med Protopy, indtil huden er helet, hvorefter behandlingen bør ophøre.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PROTOPY EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PROTOPY EPAR - sammendrag for offentligheden
English: Protopy should be prescribed by a doctor with experience in the diagnosis and treatment of atopic dermatitis.
Danish: Protopy bør kun ordineres af læger med erfaring i diagnosticering og behandling af atopisk dermatitis.
English: In adults, treatment should be started with Protopy 0.1% twice a day and treatment should be continued until the skin is clear.
Danish: Hos voksne indledes behandlingen ned Protopy 0,1 % to gange dagligt og fortsætter, til huden er helet.
English: The six main clinical studies involved 1,202 adults (over the age of 16) and 1,535 children (aged 2 to 16 years of age), and Protopy was compared either with placebo (a dummy treatment, the ointment base) or with a topical corticosteroid often used for eczema (hydrocortisone butyrate in adults, hydrocortisone acetate in children).
Danish: De seks kliniske hovedundersøgelser omfattede 1 202 voksne (over 16 år) og 1 535 børn (i alderen 2 til 16 år), og Protopy blev enten sammenlignet med placebo (virkningsløs behandling i form af salvegrundlaget) eller med et binyrebarkhormon til lokal brug, der ofte anvendes mod eksem (hydrocortisonbutyrat til voksne, hydrocortisonacetat til børn).
English: Tacrolimus, the active substance in Protopy, is an immunomodulator, this means that it works on the immune system (the body's natural defences).
Danish: Tacrolimus, det aktive stof i Protopy, er et immunmodulerende stof, dvs. det har indvirkning på immunsystemet (kroppens naturlige forsvar).
English: They recommended that Protopy be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Protopy.
English: Generally, improvement is seen within one week of starting treatment, and if there is no improvement after 2 weeks, the doctor needs to look at more treatment options.
Danish: Er der ikke sket nogen forbedring efter to uger, bør lægen overveje andre behandlingsmuligheder.
English: In children, only the lowest strength Protopy 0.03% should be used.
Danish: Til børn bør Protopy kun anvendes i den lave styrke (0,03 %).
English: Protopy should not be used in people who may be hypersensitive (allergic) to tacrolimus or to any of the other ingredients.
Danish: Protopy bør ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for tacrolimus eller andre af indholdsstofferne.
English: What is the risk associated with Protopy?
Danish: Hvilken risiko er der forbundet med Protopy?
English: The Committee for Medicinal products for Human Use (CHMP) decided that Protopy's benefits are greater than its risks for the treatment of moderate to severe atopic dermatitis in adults and children over the age of 2 who are not adequately responsive to or are intolerant of conventional therapies.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved Protopy er større end risiciene til behandling af moderat til svær atopisk dermatitis hos voksne og børn over to år, der ikke responderer tilfredsstillende på eller ikke tåler konventionelle behandlingsformer.
English: A link to Protopy has not been shown.
Danish: Der er ikke påvist nogen sammenhæng med Protopy.
English: Protopy should not be used continuously.
Danish: Protopy bør ikke anvendes i længere tid.
English: Protopy was significantly more effective than either of the 2 hydrocortisone preparations at producing improvements in the modified Eczema Area and Severity Index, although it also produced more burning than hydrocortisone.
Danish: Protopy var betydeligt mere effektivt end nogen af de to hydrocortisonpræparater til at forbedre resultaterne i score-systemet, men fremkaldte i højere grad en brændende fornemmelse på huden end hydrocortison.
English: However, doctors must ensure that the medicine is used appropriately.
Danish: Lægen bør imidlertid have dette for øje og sikre, at lægemidlet anvendes hensigtsmæssigt, og at patienten overvåges under behandlingen.
English: The lower strength of Protopy (0.03%) may also be used for this condition in children (2 years of age and above) who do not respond well to, or do not tolerate usual treatments.
Danish: I den lave styrke (0,03 %) kan Protopy desuden bruges til behandling af denne sygdom hos børn (fra 2-årsalderen), der ikke responderer på sædvanlig behandling eller ikke kan tåle denne.
English: Afterwards, application should be reduced to once a day until the skin is clear.
Danish: Herefter påføres det kun en gang dagligt, indtil huden er helet.
English: Why has Protopy been approved?
Danish: Hvorfor er Protopy blevet godkendt?
English: Protopy is used for the treatment of moderate to severe atopic dermatitis (eczema, an itchy red rash of the skin- atopic means that is linked to an allergy) in adults who do not respond well or do not tolerate usual treatments.
Danish: Protopy anvendes til behandling af moderat til svær atopisk dermatitis (eksem, kløende rødt udslæt på huden - atopisk vil sige, at det er allergisk betinget) hos voksne, der ikke responderer på sædvanlig behandling eller ikke kan tåle denne.
English: Doctors must be aware that a very small number of patients using the medicine have developed cancer (skin cancer, lymphoma).
Danish: Et meget lille antal patienter har udviklet kræft (hudkræft eller lymfom), mens de fik lægemidlet.
English: Tacrolimus calms down the immune system, and this helps relieve the skin inflammation and the itch.
Danish: Tacrolimus dæmper immunsystemet, så betændelsen og kløen mindskes.
English: The ointment should be applied as a thin layer to affected areas of the skin.
Danish: Salven påføres i et tyndt lag på de berørte hudområder.
English: What is Protopy?
Danish: Hvad er Protopy?
English: For the full list of all the side effects reported with Protopy, please see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Protopy fremgår af indlægssedlen.
English: In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness, dryness).
Danish: Atopisk dermatitis er en overreaktion af hudens immunsystem, der fremkalder en betændelsestilstand (kløe, rødt udslæt, tør hud).
English: The exact way that Protopy works in atopic dermatitis is not yet fully understood.
Danish: Det vides endnu ikke med nøjagtighed, hvordan Protopy virker mod atopisk dermatitis.
English: The full EPAR for Protopy is available here.
Danish: Den Europæiske Offentlige Vurderingsrapport (EPAR) for Protopy kan ses i sin helhed her.
English: How has Protopy been studied?
Danish: Hvordan er Protopy blevet undersøgt?
English: If possible, patients should use less frequent applications, or the lower strength as their condition improves.
Danish: Efterhånden som tilstanden bedres, påføres salven mindre ofte, eller der skiftes til den lave styrke.
English: What benefit has Protopy shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Protopy?
English: What is Protopy used for?
Danish: Hvad anvendes Protopy til?
English: The main measure of effectiveness was the improvement in the eczema seen at the end of the study (3 or 12 weeks) using a scoring system (the modified Eczema Area and Severity Index) that looks at all the symptoms of atopic dermatitis.
Danish: Til dette formål blev der anvendt et score-system (det såkaldte Modified Eczema Area and Severity Index), hvor alle symptomer på atopisk dermatitis tages i betragtning.
English: How is Protopy used?
Danish: Hvordan anvendes Protopy?
English: How does Protopy work?
Danish: Hvordan virker Protopy?
English: The marketing authorisation was renewed on 11-2006.
Danish: Denne tilladelse blev fornyet den
English: Such reactions may be life-threatening.
Danish: Sådanne reaktioner kan være livstruende.
English: This is because it is not known if the medicine is safe to use in these age groups.
Danish: Det skyldes, at man ikke ved, om lægemidlet er sikkert at bruge til denne aldersgruppe.
English: The final volume is approximately 21.3 ml.
Danish: Den endelige volumen er cirka 21,3 ml.