natgillin/translations-raw huggingface dataset:
På baggrund af den langsomme og begrænsede metabolisering af closantel, den høje proteinbinding og retention i plasma samt den lange eliminationstid fra vævene vurderer udvalget, at forskellene i produktformuleringerne, der kan betyde forskellige absorptionshastigheder fra injektionsstedet, ikke bør have nogen indvirkning på den endelige eliminationshastighed fra de spiselige væv, ud over selve injektionsstedet.
The Committee considered that, due to the slow and limited metabolism of closantel, the high protein binding and retention in plasma, and the long elimination time from tissues, the differences seen in the product formulations, which may lead to different rates of absorption from the injection site, should not influence the final rate of elimination from the edible tissues, other than at the injection site itself.
• På baggrund af de foreliggende data vurderer CVMP, at tilbageholdelsestiderne for kød og indmad fra behandlede får bør ændres af hensyn til forbrugersikkerheden.
• on the basis of the available data, the CVMP considered the withdrawal periods for meat and offal derived from treated sheep should be amended to provide assurance for consumer safety;
Når man imidlertid ser på resultaterne af dette centrale studie og de begrænsede oplysninger, de giver, kan konklusionen være mangelfuld, da restkoncentrationerne i de indsamlede væv ikke lå under de respektive MRL-værdier.
However, considering the results of this pilot study, and the limited information that they provide, this conclusion might not be adequate, as the residue concentrations in the sampled tissues did not fall below the respective MRLs; therefore, it was not possible to know which would be the withdrawal period determining tissue from these data.
• Dataene fra studie 1 viser, at det er leveren, der er det afgørende væv for fastsættelse af tilbageholdelsestiden, og at de "alternative metoder", jf. anbefalingerne i CVMP's vejledning i metoder til harmonisering af tilbageholdelsestider (EMEA/CVMP/036/95), bør anvendes til fastsættelse af tilbageholdelsestiden, da de statistiske forudsætninger ikke er opfyldt ved anvendelse af den foretrukne statistiske analyse.
• the data from Study 1 show that the liver is the withdrawal period determining tissue, and that the ‘alternative method', as recommended in CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95), should be used to determine the withdrawal period as the statistical assumptions are not all met when trying to use the preferred statistical analysis.
Propylenglykols viskositet er større end glycerolformals viskositet, der igen er større end vands viskositet.
The viscosity of propylene glycol is greater than that of glycerol formal which is greater than the viscosity of water.
Det blev vurderet, at indholdet af glycerolformal i et produkt vil have mindre betydning for produktets generelle viskositet end indholdet af propylenglykol, sammenholdt med vands viskositet.
It was considered that the presence of glycerol formal in one product would have less of an effect than propylene glycol on the overall viscosity of the product, when compared to that of water.
De berørte indehavere af markedsføringstilladelse fremlagde to restkoncentrationsstudier, der ikke var sammenlignelige med hensyn til datapålidelighed, studiedesign og rapportering, og hvis resultater derfor heller ikke var sammenlignelige.
Two residues depletion studies were provided by the MAHs involved in the procedure, which were not comparable in terms of the reliability of the data, study design and reporting, and subsequently their outcomes.
Nedbrydning af restkoncentrationer i kød og indmad hos får
Residue depletion in sheep meat and offal
Restkoncentrationerne ved injektionsstedet lå under MRLværdien for muskler 61 dage efter administration.
Residues at the injection site were below the MRL for muscle at 61 days post administration.
Hvad angår følsomhed, var kvantificeringsgrænsen for muskelvæv i studie 1 fastsat til 150 µg/kg, mens den i studie 2 var mindre sensitiv, nemlig 500 µg/kg.
In terms of sensitivity, the limit of quantification in Study 1 was determined as 150 µg/kg in muscle, whereas the limit of quantification in Study 2 was
De to studier anvendte ikke samme metoder til analyse af fårenes væv, idet der i studie 1 blev anvendt en LC-MS/MS-analysemetode, mens der i studie 2 blev anvendt en HPLC-FD-analysemetode.
The analysis of the sheep tissues differed between the two studies, with study 1 using LC-MS/MS as their analytical method, and study two using HPLC-FD.
Markedsføringstilladelsen for dette produkt blev ændret i 2016, og tilbageholdelsestiderne for får (kød og indmad) blev øget fra 77 dage to 107 dage som følge af data, der fremkom under ændringsproceduren.
Another (nationally-authorised) version of Flukiver Solution for Injection has been authorised in France since 1981; the marketing authorisation for this product was varied in 2016 and the withdrawal periods for sheep (meat and offal) were increased from 77 days to 107 days as a result of data provided during the variation procedure.
Der blev fremlagt data, der var baseret på closantels farmakokinetik, og som viste, at forskelle i formuleringerne, og dermed mulige forskelle i absorptionshastigheden fra injektionsstedet, ikke vil have betydning for den generelle elimination fra de spiselige væv, ud over fra selve injektionsstedet.
Data were provided, based on the pharmacokinetics of closantel, that demonstrated that the formulation differences, and thereby the potential differences in the rates of absorption from the injection site, would not affect the overall elimination from the edible tissues, other than from the injection site itself.
I GLP-studiet blev vævsprøver fra injektionsstedet indsamlet på dag 2, 7, 14, 24 og 29 efter behandling og analyseret iht.
In the GLP study, the injection sites were sampled on days 2, 7, 14, 24 and 29 days after treatment and analysed using an HPLC-FD method of analysis, validated in line with current requirements.
Prøver på alle spiselige væv, herunder injektionsstedet, blev indsamlet på dag 19, 40, 61, 89 og 103 efter behandling og analyseret iht.
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.
• 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.
• 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.
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.
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.
Restkoncentrationerne af closantel i de centrale vævsprøver fra injektionsstedet lå under MRLværdierne 29 dage efter administration.
The concentration of closantel residues in the core injection site samples were below the MRL at 29 days after administration.
Må ikke anvendes hos hunfår, der producerer mælk bestemt til konsum (heller ikke i goldperioden).
Not authorised for use in ewes producing milk for human consumption including during the dry period.
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.
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.
Det er påvist, at jo højere produktets viskositet er, desto langsommere er absorptionshastigheden fra injektionsstedet generelt.
It has been shown that, in general, the higher the viscosity of the product, the slower the rate of absorption from the injection site.
Produktet blev administreret ved subkutan injektion hos får i den anbefalede enkeltdosis på 5 mg closantel pr. kg kropsvægt.
The product was administered via subcutaneous injection to sheep at the single recommended dose of 5 mg closantel per kg body weight.
Kun 10 % udskilles imidlertid inden for 48 timer, hvorefter hastigheden daler yderligere, idet 1-2 % af dosen elimineres hver dag.
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.
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.
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.
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.
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.
Indehaver af markedsføringstilladels
Marketing authorisation holder
Det frigives langsomt fra plasma og metaboliseres meget langsomt og bliver derfor længe i kredsløbet.
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.
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.
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.
• 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.
• 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.
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.
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.
• 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.
• 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.
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.
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.
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)
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)
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.
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.
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.
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.
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.
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.
"alternative" metode i overensstemmelse med CVMP's vejledning i metoder til harmonisering af tilbageholdelsestider (EMEA/CVMP/036/95)1.
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.
De specificerede pH-værdier for de produkter, der blev anvendt i studie 1 og 2, lå inden for samme interval.
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.
• 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.
• 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.
Disse forskellige mængder kan betyde, at produkterne har forskellig viskositet og dermed forskellig hastighed for absorption af closantel fra injektionsstedet.
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.
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.
1 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link less sensitive, at 500 µg/kg.
Santiola 50 mg/ml Solution for Injection for Cattle and Sheep får
Santiola 50 mg/ml Solution for Injection for Cattle and Sheep sheep sheep: subcutaneous
en HPLC-FD-analysemetode, der var valideret i overensstemmelse med gældende krav.
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.
Pulver: 15 mg 1 Hætteglas
powder: 15 mg 1 vial
EU/1/00/140/001 Visudyne 15 mg Pulver til infusionsvæske, opløsning
EU/1/00/140/001 Visudyne
Intravenøs anvendelse
Immediate packaging
Dette sammendrag blev sidst opdateret 09-2007.
This summary was last updated in 09-2007
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Protopy til Astellas Pharma GmbH den 28. februar 2002.
The European Commission granted a marketing authorisation valid throughout the European Union, for Protopy to Astellas Pharma GmbH on 28 February 2002.
I endnu en undersøgelse blev Protopy anvendt i op til 4 år hos ca. 800 patienter.
Another study has also looked at the use of Protopy for up to 4 years in about 800 patients.
Andre oplysninger om Protopy:
Other information about Protopy:
Protopy bør ikke anvendes til børn under 2 år.
Protopy should not be used in children under 2 years of age.
Hvis du ønsker yderligere oplysninger på grundlag af CHMP's anbefalinger, kan du læse den faglige drøftelse (der ligeledes er en del af EPAR).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
I den længstvarende undersøgelse kunne Protopy anvendes gentagne gange uden at miste sin virkning.
In the longer study, Protopy could be used repeatedly without losing its effectiveness.
Protopy er en hvid til let gullig salve, der indeholder enten 0,1 % eller 0,03 % af det aktive stof tacrolimus.
Protopy is a white to slightly yellowish ointment that contains either 0.1% or 0.03% of the active ingredient tacrolimus.
Ved indledning af behandlingen gives lægemidlet to gange dagligt i op til tre uger.
Treatment should be started as twice a day for up to three weeks.
Sikkerheden og virkningen af Protopy er undersøgt hos over 13 500 patienter, der blev behandlet med tacrolimus salve i kliniske undersøgelser.
The safety and effectiveness of Protopy has been studied in more than 13,500 patients treated with tacrolimus ointment in clinical trials.
Tacrolimus er siden midten af 1990'erne blevet anvendt til at mindske afstødningen hos transplantationspatienter (når immunsystemet angriber det transplanterede organ).
Tacrolimus has been used since the mid-1990's to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ).
De hyppigste bivirkninger (som ses hos flere end 1 ud af 10 patienter) er en brændende fornemmelse og kløe på påføringsstedet.
The most common side effects (seen in more than 1 patient in 10) are burning sensation and itching at the application site.
Hvert af de berørte områder behandles med Protopy, indtil huden er helet, hvorefter behandlingen bør ophøre.
Each affected area is treated with Protopy until the skin is clear and then treatment should be stopped.
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PROTOPY EPAR - sammendrag for offentligheden
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PROTOPY EPAR summary for the public
Protopy bør kun ordineres af læger med erfaring i diagnosticering og behandling af atopisk dermatitis.
Protopy should be prescribed by a doctor with experience in the diagnosis and treatment of atopic dermatitis.
Hos voksne indledes behandlingen ned Protopy 0,1 % to gange dagligt og fortsætter, til huden er helet.
In adults, treatment should be started with Protopy 0.1% twice a day and treatment should be continued until the skin is clear.
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).
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).
Tacrolimus, det aktive stof i Protopy, er et immunmodulerende stof, dvs. det har indvirkning på immunsystemet (kroppens naturlige forsvar).
Tacrolimus, the active substance in Protopy, is an immunomodulator, this means that it works on the immune system (the body's natural defences).
Udvalget anbefalede udstedelse af markedsføringstilladelse for Protopy.
They recommended that Protopy be given marketing authorisation.
Er der ikke sket nogen forbedring efter to uger, bør lægen overveje andre behandlingsmuligheder.
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.
Til børn bør Protopy kun anvendes i den lave styrke (0,03 %).
In children, only the lowest strength Protopy 0.03% should be used.
Protopy bør ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for tacrolimus eller andre af indholdsstofferne.
Protopy should not be used in people who may be hypersensitive (allergic) to tacrolimus or to any of the other ingredients.
Hvilken risiko er der forbundet med Protopy?
What is the risk associated with Protopy?