natgillin/translations-raw huggingface dataset:
Albert-SchweitzerGasse 3, 1140 WIEN, Østrig µg/h transdermales Matrixpflaster mikrogram per time
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Fentanilo Matrix ratiopharm 25 microgramos/h parches transdérmicos EFG Storbritannien Telfanyl 25 microgram/hr Transdermal patch Tyskland
Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006.
Fentanyl-ratiopharm 25 µg/h Matrixpflaster og andre berørte navne (se Vedlæg I)
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names International Non-Proprietary Name (INN): fentanyl
Symptomerne på toksicitet er dyb sedation, ataksi, miosis, kramper samt respirationsdepression, som er det væsentligste symptom.
Significant difference has been identified with regard to the proposed indication, posology and contraindications in the product information and the demonstration of bioequivalence and this was considered to be of serious public health concern.
Mængden af analgetikaforbrug i de forudgående 24 timer bestemmes.
The arbitration procedure started on 24 January 2007 with the adoption of a list of questions.
BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR ÆNDRING AF PRODUKTRESUMÉET (-RESUMÉERNE), ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMEA
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Størstedelen af disse reaktioner var lette eller moderate.
The majority of these reactions were mild or moderate.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Revestive den 30. august 2012.
The European Commission granted a marketing authorisation valid throughout the European Union for Revestive on 30 August 2012.
Desuden udviste Revestive en acceptabel sikkerhedsprofil.
Furthermore, Revestive showed an acceptable safety profile.
Hvis der ikke iagttages gavnlig virkning, bør behandlingen ophøre.
If a benefit is not observed, treatment should be stopped.
CHMP konkluderede derfor, at fordelene ved Revestive er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP therefore concluded that Revestive's benefits are greater than its risks and recommended that it be given marketing authorisation.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Revestive.
This is a summary of the European public assessment report (EPAR) for Revestive.
Virksomheden vil fremlægge yderligere data om lægemidlets sikkerhed fra et patientregister.
The company will provide more data about the medicine's safety from a registry of patients.
Andre oplysninger om Revestive
Other information about Revestive
Revestive teduglutid
Revestive teduglutide
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Revestive?
What measures are being taken to ensure the safe and effective use of Revestive?
Hvorfor blev Revestive godkendt?
Why is Revestive approved?
Det er ikke en praktisk vejledning i, hvordan Revestive bør anvendes.
It is not intended to provide practical advice on how to use Revestive.
Til sammenligning var tallet 30 % (13 ud af 43) af dem, der fik placebo (en virkningsløs behandling).
This compares with 30% (13 out of 43) of those given placebo (a dummy treatment).
Hvad er Revestive, og hvad anvendes det til?
What is Revestive and what is it used for?
Revestive må ikke anvendes hos patienter, der har eller formodes at have kræft.
Revestive must not be used in patients who have, or are suspected to have, cancer.
Patienten eller omsorgsgiveren kan injicere lægemidlet efter at have fået passende oplæring.
Patients or their carers can inject the medicines once they have received adequate training.
Revestive indeholder det aktive stof teduglutid.
Revestive contains the active substance teduglutide.
Da antallet af patienter med denne lidelse er lavt, betragtes sygdommen som "sjælden", og Revestive blev udpeget som "lægemiddel til sjældne sygdomme" den 11. december 2001.
Because the number of patients with the condition is low, the disease is considered ‘rare', and Revestive was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 December
Lægemidlet udleveres kun efter recept, og behandlingen bør indledes under opsyn af en læge med erfaring i behandling af korttarmssyndrom.
The medicine can only be obtained with a prescription, and treatment should be started under the supervision of a doctor with experience in treating short bowel syndrome.
Af én undersøgelse hos voksne fremgik det, at 63 % (27 ud af 43) af dem, der modtog Revestive, fik deres parenterale ernæring reduceret med mindst en femtedel efter 20 uger og fastholdt dette reducerede indtag efter 24 uger.
In one study in adults, 63% (27 out of 43) of those who received Revestive had their parenteral nutrition at 20 weeks reduced by at least a fifth and maintained this reduced intake at 24 weeks.
Den fuldstændige EPAR for Revestive findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Revestive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Hvilke risici er der forbundet med Revestive?
What are the risks associated with Revestive?
Af en anden undersøgelse hos børn fremgik det, at 53 % (8 ud af 15) af dem, der modtog Revestive, fik deres parenterale ernæring reduceret med mindst en tiendedel efter 12 uger, mens ingen (0 ud af 5) af de patienter, der modtog standardbehandling, opnåede samme resultat.
In a second study in children, 53% (8 out of 15) of those who received Revestive had their parenteral nutrition at 12 weeks reduced by at least a tenth, while none (0 out of 5) of the patients who received a standard treatment achieved the same.
De hyppigst indberettede bivirkninger ved Revestive (som kan forekomme hos mere end 1 ud af 10 personer) var luftvejsinfektioner (infektioner i halsen, bihulerne, luftvejene eller lungerne), hovedpine, mavesmerter og udspilet mave, kvalme, opkastning og rødme, smerte eller hævelse på injektionsstedet.
The most commonly reported side effects with Revestive (which may occur in more than 1 in 10 patients) were respiratory tract infections (infections of the throat, sinuses, airways or lungs), headache, belly ache and swollen stomach, nausea, vomiting, and reddening, pain or swelling at the site of the injection.
Desuden sås hos patienter med en stomi (en kunstig åbning forrest på maven til opsamling af afføring eller urin) generelt forekommende komplikationer, såsom hævelse af stomien.
In addition, patients with a stoma (an artificial opening at the front of the abdomen to collect faeces or urine) commonly experienced complications, such as swelling of the stoma.
Patienter med behov for store mængder parenteral ernæring kan have fordel af en væsentlig reduktion, mens patienter med lille behov for parenteral ernæring får mulighed for helt at ophøre dermed.
Patients who need high volumes of parenteral nutrition may benefit from a significant reduction, whereas patients in need of low amounts may have the chance to be weaned off completely.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Revestive findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Revestive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Revestive gives som en injektion under huden på maven.
Revestive is given as an injection under the skin of the abdomen.
Revestive er i to undersøgelser blevet påvist at mindske behovet for parenteral ernæring.
Revestive has been shown in 2 studies to reduce the amount of parenteral nutrition that patients need.
Det må ikke anvendes hos patienter, der har haft mave-tarmkræft eller leverkræft inden for de seneste fem år.
It must not be used in patients who have had a gastrointestinal cancer (cancer of the stomach, gut or liver) in the last five years.
Hvis du ønsker yderligere oplysninger om behandling med Revestive, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Revestive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Undersøgelser viser, at Revestive er gavnligt for patienter med korttarmssyndrom, da det væsentligt mindsker behovet for parenteral ernæring.
Studies show that Revestive is beneficial for patients with short bowel syndrome as it significantly reduces the amount of parenteral nutrition they need.
Korttarmssyndrom er en tilstand, hvor næringsstoffer og væsker ikke absorberes tilstrækkeligt af tarmen, sædvanligvis fordi en stor del heraf er fjernet ved et kirurgisk indgreb.
Short bowel syndrome is a condition in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed.
Patienter med korttarmssyndrom får som regel tilført næringsstoffer i form af en infusion direkte i en vene (parenteral ernæring).
Patients with short bowel syndrome are usually given nutrients as an infusion directly into their veins (parenteral nutrition).
Det aktive stof i Revestive, teduglutid, ligner kroppens eget hormon "glukagonlignende peptid 2 (GLP-2)", som produceres i tarmen og stimulerer absorptionen af næringsstoffer fra tarmen.
The active substance in Revestive, teduglutide, is similar to human glucagon-like peptide 2 (GLP-2), a hormone made in the gut that increases absorption of nutrients from the intestine.
Teduglutid virker på samme måde som GLP-2 og øger absorptionen fra tarmen ved at øge blodgennemstrømningen i tarmen, mindske den tid, det tager føden at passere gennem tarmen, og nedsætte mavesækkens udskillelse af syre, der kan hæmme absorptionen fra tarmen.
Teduglutide works in a similar way to GLP-2 and increases intestinal absorption by: increasing blood flow to and from the gut, reducing the speed at which food passes through and reducing acid secretions in the stomach which can interfere with absorption in the intestine.
Hvilke fordele viser undersøgelserne, at der er ved Revestive?
What benefits of Revestive have been shown in studies?
Hvis du ønsker praktisk vejledning om anvendelsen af Revestive, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Revestive, patients should read the package leaflet or contact their doctor or pharmacist.
Den anbefalede dosis er 0,05 mg pr. kg legemsvægt én gang dagligt.
The recommended dose is 0.05 mg per kilogram body weight once a day, with the daily dose reduced by half in patients with moderate or severely reduced kidney function.
Hvordan anvendes Revestive?
How is Revestive used?
I forhold til GLP2 har teduglutid den fordel, at det forbliver længere tid i kroppen.
Teduglutide has the advantage of lasting longer than GLP-2 in the body.
Revestive er et lægemiddel, der anvendes til behandling af voksne og børn på 1 år og derover med korttarmssyndrom.
Revestive is a medicine for treating short bowel syndrome (or short gut) in adults and children aged 1 year and above.
Hvordan virker Revestive?
How does Revestive work?
Den fuldstændige liste over indberettede bivirkninger ved Revestive fremgår af indlægssedlen.
For the full list of all side effects reported with Revestive, see the package leaflet.
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Revestive.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revestive have also been included in the summary of product characteristics and the package leaflet.
Den endelige undersøgelsesrapport forelægges de nationale kompetente myndigheder:
The final study report shall be submitted to the National Competent Authorities:
Oplysningsmaterialet skal sikre, at sundhedspersoner og patienter/omsorgsgivere er i stand til at gennemføre administrationen af produktet på grundlag af anvisningerne i produktinformationen.
The educational materials should ensure that healthcare professionals and patients/carers are able to successfully administer the product based on the instructions in the product information.
Protokollen forelægges de nationale kompetente myndigheder:
The protocol shall be submitted to the National Competent Authorities:
Enhver indehaver af en markedsføringstilladelse for adrenalinautoinjektorer skal udføre en farmakokinetisk/farmakodynamisk undersøgelse til at skaffe indblik i betydningen af forskellige faktorer for adrenalinets distribution, eksponering og aktivitet ved administration med adrenalin-autoinjektoren.
Each Marketing Authorisation Holder of adrenaline auto-injectors shall perform a PK/PD study to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via their adrenaline auto-injector device.
De nationale kompetente myndigheder i medlemsstaterne eller i givet fald i referencemedlemsstaten (staterne) sikrer, at indehaverne af markedsføringstilladelse opfylder følgende betingelser:
National Competent Authorities of Member States or Reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Indehaverne af markedsføringstilladelse for adrenalin-autoinjektorer forelægger en risikostyringsplan for de nationale kompetente myndigheder.
The Marketing Authorisation Holders of adrenaline auto-injectors shall submit to the National Competent Authorities a Risk Management Plan containing key elements as described in the CHMP assessment report (including educational materials).
Østrig og Ungarn
Austria and Hungary
Besvarelserne blev indleveret til EMEA den 12. september 2006.
The responses were submitted to the EMEA on 12 September 2006.
Denne undersøgelse var ikke til rådighed for CMD(v).
This study was not available to CMD(v).
Belgien, Tjekkiet, Danmark, Spanien, Finland, Italien, Luxembourg, Nederlandene, Norge, Polen og Slovakiet
Belgium, Czech Republic, Denmark, Spain, Finland, Italy, Luxembourg, The Netherlands, Norway, Poland and Slovakia
Variationen mellem de enkelte køer var 1-3 timer.
The variation between individual cows was 1-3 hours.
Den anbefalede dosis og behandlingstid må ikke overskrides.
The recommended dose and treatment time must not be exceeded.
Indgivelsesvej: Oral anvendelse.
Route of administration: Oral use.
Biotilgængeligheden efter oral indgift er ca. 76%.
The bioavailability after per-oral dosing is about 76 %.
FREMSTILLERENS BATCHNUMMER Batch:
MANUFACTURER'S BATCH NUMBER Batch
Der er ikke udført forsøg af denne type med kvæg.
No such studies have been conducted with cattle.
I tilfælde af overdosering behandles symptomatisk.
In cases of overdose symptomatic therapy should be given.
I Finland er produktet godkendt til indikationen "behandling af feber og inflammation hos kvæg."
In Finland the product has been authorised for the indication: “The treatment of fever and inflammation in cattle”.
Hænderne bør vaskes efter håndtering af lægemidlet.
Hands should be washed after the administration of the drug.
Som ovenstående
As above
Begrundelsen herfor var, at de nationale kompetente myndigheder i Belgien og Norge fandt, at produktet kan udgøre en alvorlig risiko for dyrs sundhed, fordi dets virkning ikke er tilstrækkelig velunderbygget i ansøgningens dokumentation.
The reason for this was that the national competent authorities of Belgium and Norway considered that this medicinal product could present a potential serious risk to animal health on the ground that the efficacy has not been sufficiently substantiated in the dossier.
Dette var også den ansøgte indikation ved indledningen af den gensidige anerkendelsesprocedure.
This is also the indication applied for at the start of the mutual recognition procedure (MRP).
Reduktion af pyreksi eller feber og lindring af inflammation anses for at være vigtige kliniske indikationer, som bør bibeholdes, da de er tilstrækkeligt veldokumenterede.
Reducing of pyrexia or fever and alleviation of inflammation are considered important clinical claims that should be retained as they have been demonstrated clearly enough.
Både smerte i den inficerede bagfjerding og øget størrelse er tegn på inflammation.
Both pain in the infected quarter and increased size are indicative of inflammation.
Koncentrationer over 0,1 µg/ml i plasma blev målt 24 timer efter indgift.
Concentrations over 0,1 µg/ml in plasma were measured 24 hours after the administration of the drug.
Sammen med besvarelsen blev der imidlertid forelagt en undersøgelse til bekræftelse af dosis, som anses for at være af afgørende betydning for vurderingen af virkningen: "Dose confirmation of oral ketoprofen in endotoxin-induced mastitis in cows, Study 06-131-LC, August 7th, 2006".
However, a dose confirmation study, submitted with the response, is considered pivotal for the assessment of the efficacy: “Dose confirmation of oral ketoprofen in endotoxin-induced mastitis in cows, Study 06-131-LC, August 7th, 2006”.
En ødemnedsættende virkning kræver sædvanlig vurdering gennem flere dage, og et NSAID kan anses for at have begrænset virkning her.
An anti-oedemic effect is usually evaluated over several days, and an NSAID may be considered limited in its efficacy here.
Det somatiske celletal blev påvirket af provokationen med kun ringe forskel mellem grupperne.
Somatic cell counts were affected by the challenge, and few differences exist between the groups.
Det er dokumenteret, at den antiinflammatoriske effekt i væv fortsætter, selv efter at plasmakoncentrationen er faldet.
The anti-inflammatory effect in tissues has been documented to continue even after the plasma concentration has decreased.
At der i det hele taget rapporteres om forskel i yverets størrelse i den inokulerede bagfjerding under sådanne eksperimentelle forhold, er bemærkelsesværdigt.
That a difference in udder size in the inoculated quarter is reported at all under these experimental conditions is noteworthy.
Ansøger eller indehaver af markedsføringstilladelse
Applicant or Marketing Authorisation Holder
Må ikke anvendes til dyr, som helt har mistet appetitten, da dette kan medføre utilstrækkelig absorption af ketoprofen.
Do not use in animals which have completely lost their appetite because this could lead to insufficient absorption of ketoprofen.
Koncentrationen af thromboxan blev målt både i mælk og plasma.
Thromboxane levels were measured in both milk and plasma.
Skønt ketoprofens virkninger ikke kun gælder thromboxan-aktiviteten (ketoprofen har også lipoxygenase-aktivitet), er thromboxan-aktiviteten en følsom parameter, ikke kun for bedømmelsen af inflammationen i denne eksperimentelle model, men også når det gælder muligheden for at ekstrapolere til feltbetingelser i et vist omfang.
Although not all effects of ketoprofen are covered by thromboxane activity (ketoprofen also has lipooxygenase activity), thromboxane activity is a sensitive parameter, not only for evaluating inflammation in this experimental model, but also for allowing extrapolation to the field condition up to a certain point.
Søg straks lægehjælp i sådanne tilfælde.
In these cases take immediate contact to a doctor.
Men eftersom de farmakokinetiske data gav mulighed for at optimere dosis (så at den totale eksponering fra de to produkter var den samme), kan det konkluderes, at der foreligger en sammenhæng, der giver grundlag for, at den velunderbyggede anvendelse også anses for at gælde for Dolovet.
However, given that the pharmacokinetic data allowed to optimise the dose (keeping overall exposure comparable between the two products), it is concluded that a bridge exists that allows wellestablished use to apply to Dolovet.
Hvis man accepterer, at der foreligger en sådan sammenhæng, bør de kliniske indikationer for Ketofen, der er dokumenteret i litteraturen, for en stor del også kunne gøres gældende for Dolovet.
If one accepts that a bridge exists, then the clinical indications that exist for Ketofen, as evidence in the literature, should apply in large part to Dolovet.
Skønt de to produkters ækvivalens ikke er formelt godtgjort, svarer de til hinanden i virkning sammenlignet med placebo, hvad angår en række kritiske parametre, både kliniske og af anden art (thromboxan B2indholdet i plasma).
Even though equivalence has not been formally shown, the two products perform similarly when compared to placebo in regards to a number of critical parameters, both clinical and otherwise (thromboxane B2 levels in plasma).
Indledningen af kælvning kan forsinkes, når ketoprofen gives umiddelbart før kælvning.
The induction of parturition can be delayed when ketoprofen is given just before parturition.
I modsætning til, hvad der gør sig gældende for ketoprofen som injektion, er resultaterne for Dolovet ikke så "klare" for mælk som for plasma.
Opposed to injectable ketoprofen the results for milk are not “as clear” for Dolovet as what they are for plasma.
Efter oral indgift af den anbefalede dosis på 4 mg/kg til kvæg, før tildeling af kraftfoder, blev den højeste plasmakoncentration af ketoprofen (Cmax 3,9 µg/ml) opnået på ca. 2 timer.
In cattle, after the recommended dose of 4 mg/kg of ketoprofen per os before feeding the concentrate, the highest concentration of ketoprofen in plasma (Cmax3,9 µg/ml) was achieved in about 2 hours.
Ved ansøgninger for generiske lægemidler skal deres bioækvivalens godtgøres.
For generic applications bioequivalence must be demonstrated.
På grundlag af de forelagte oplysninger og den veldokumenterede anvendelse af ketoprofen finder CVMP følgende indikation for behørigt begrundet:
Considering then the data provided and the well-established use of ketoprofen, CVMP is of the opinion that the following claim can be substantiated:
Mælkeydelsen faldt i alle grupper og steg efter provokationen lige meget i alle grupper.
Milk yield dropped for all groups and rose again after challenge, similarly for all groups.
BILAG I LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJ OG INDEHAVER AF MARKEDSFØRINGSTILLADELSE
ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
CVMP indledte på sit møde den 14.-16. marts 2006 en indbringelsesprocedure i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer, for Dolovet vet, 2,4 g oralt pulver.
The CVMP during its meeting of 14-16 March 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Dolovet vet 2.4g oral powder.
To timer efter provokationen blev dyrene behandlet efter inddeling i følgende grupper: Gruppe A: saltvand, Gruppe B: ketoprofen 2 mg/kg oralt, Gruppe C: ketoprofen 4 mg/kg oralt, Gruppe D: ketoprofen 3 mg/kg intramuskulært.
Treatment was conducted two hours after challenge and the groups were Group A: Saline, Group B: 2 mg/kg ketoprofen orally, Group C: 4 mg/kg ketoprofen orally, and Group D: 3 mg/kg ketoprofen intramuscularly.
LÆGEMIDDELFORM Oralt pulver.
PHARMACEUTICAL FORM Oral powder.
36 raske, lakterende køer blev provokeret ved infusion i den ene bagfjerding af endotoxin Bacto E. coli 026:B6 lipopolysaccharid B (LPS).
36 healthy lactating cows were challenged in one hindquarter, infused with endotoxin Bacto E. coli 026:B6 lipopolysaccharide B (LPS).