FrancophonIA/ELRC3.0 huggingface dataset:
English: Dilute the total volume of Elaprase concentrate for solution for infusion required in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion .
Danish: Fortynd den samlede mængde Elaprase koncentrat til infusionsvæske, opløsning, der er nødvendig, i 100 ml natriumchloridinfusionsvæske 9 mg/ml (0,9 %).
English: Each vial of Elaprase contains 6 mg of idursulfase.
Danish: Hvert hætteglas med Elaprase indeholder 6 mg idursulfase.
English: • Swollen tongue, indigestion
Danish: • Hævet tunge, fordøjelsesbesvær
English: Fertility No effects on male fertility were seen in reproductive studies in male rats.
Danish: I reproduktionsstudier med hanrotter blev der ikke observeret nogen virkninger på fertiliteten hos hanner.
English: Each ml contains 2 mg of idursulfase.
Danish: Hver ml indeholder 2 mg idursulfase.
English: Elaprase is for intravenous infusion and must be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion prior to use.
Danish: Elaprase er beregnet til intravenøs infusion og skal fortyndes med natriumchlorid 9 mg/ml (0,9%) infusionsvæske inden anvendelse.
English: Severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 if hypersensitivity is not controllable.
Danish: Alvorlig eller livstruende overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Elaprase has to be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion before use.
Danish: Elaprase skal fortyndes med natriumchlorid-infusionsvæske 9 mg/ml (0,9 %) inden brug.
English: If an anaphylactoid/anaphylactic reaction occurs the infusion should be immediately suspended and appropriate treatment and observation initiated.
Danish: Infusionen skal straks indstilles, og passende behandling og observation iværksættes, hvis en anafylaktoid/anafylaktisk reaktion opstår.
English: Patients experiencing severe or refractory anaphylactoid/anaphylactic reactions may require prolonged clinical monitoring.
Danish: Længerevarende klinisk overvågning kan være påkrævet for patienter, som har alvorlige eller refraktære anafylaktoide/anafylaktiske reaktioner.
English: MARKETING AUTHORISATION HOLDER
Danish: Indehaveren af markedsføringstilladelsen
English: For instructions for use, see section 6.6.
Danish: For instruktioner om brug af lægemidlet, se pkt.
English: Each vial contains 6 mg of idursulfase.
Danish: Hvert hætteglas indeholder 6 mg idursulfase.
English: In a post-hoc analysis of immunogenicity in studies TKT024 and TKT024EXT (see section 4.8), patients were shown to have either the mis-sense mutation or the frameshift / nonsense mutation.
Danish: I en post-hoc immunogenicitetsanalyse af data fra TKT024- og TKT024EXT-studierne (se pkt.
English: If you use more Elaprase than you should
Danish: Hvis De har fået for meget Elaprase
English: Skin and subcutaneous tissue disorders Urticaria, rash, pruritus, erythema Musculoskeletal and connective disorders Arthralgia General disorders and administration site conditions Pyrexia, chest pain
Danish: Artralgi Almene symptomer og reaktioner på administrationsstedet Pyreksi, brystsmerter
English: • Infusion-site swelling, swelling of the extremities, facial swelling
Danish: • Hævelse på infusionsstedet, hævelse i ben/arme, hævelse i ansigtet
English: Speak with your healthcare professional if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, De er i tvivl om.
English: Posology
Danish: Journalføring
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: - Spørg lægen, apoteketspersonalet eller sundhedspersonalet, hvis der er mere, De vil vide.
English: If you have missed an Elaprase infusion, please contact your doctor.
Danish: Kontakt Deres læge, hvis De ved en fejl ikke har fået Deres infusion med dette lægemiddel.
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Danish: Er De i tvivl, så spørg lægen.
English: BACKGROUND INFORMATION
Danish: YDERLIGERE OPLYSNINGER
English: European Medicines Agency Evaluation of Medicines for Human Use
Danish: Brug af anden medicin
English: The Rapporteur was Dr Karl Broich and Co-Rapporteur was Dr Eric Abadie.
Danish: Takykardi, bradykardi.
English: These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Danish: Medlemsstat Indehaver af markedsføringstillade lse
English: During their July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Fentanylratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: anbefalede CHMP på grundlag af den dokumentation, der er forelagt af indehaveren af markedsføringstilladelsen, og den faglige drøftelse i udvalget udstedelse af de markedsføringstilladelse(r) og ændring af det produktresumé og den etikettering og indlægsseddel, der fremgår af bilag III, for Fentanyl "ratiopharm" og tilknyttede navne - se bilag I.
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Danish: DE/H/0739/01/MR Frankrig
English: Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Danish: Fentanyl-ratiopharm anvendes til behandling af svære og langvarige smerter, der kun kan lindres tilstrækkeligt med stærke smertestillende midler.
English: London, 23 October 2007 EMEA/338591/2007
Danish: Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spanien
English: This refers to the extension of the indication to non-cancer patients, the choice of conversion tables, whether contraindication for breastfeeding and for interactions with partial agonist opioids should be given inn the product information and the studies needed to demonstrate bioequivalence with the reference medicinal product.
Danish: Indbringelsesproceduren i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF vedrørte uenighed om følgende punkter: 1- Den påtænkte udvidelse af den terapeutiske indikation til andre svære kroniske smerter end cancersmerter 2- Hvilke(n) omregningstabel(ler), der skal indgå i produktresuméet 3- Hvorvidt amning og sideløbende brug af opioider af typen partielle agonister bør være kontraindiceret 4- Kravet om, at bioækvivalensundersøgelserne påviser ækvivalens med referenceproduktet
English: 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
Danish: Albert-SchweitzerGasse 3, 1140 WIEN, Østrig µg/h transdermales Matrixpflaster mikrogram per time
English: 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.
Danish: Fentanilo Matrix ratiopharm 25 microgramos/h parches transdérmicos EFG Storbritannien Telfanyl 25 microgram/hr Transdermal patch Tyskland
English: 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
Danish: Fentanyl-ratiopharm 25 µg/h Matrixpflaster og andre berørte navne (se Vedlæg I)
English: 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.
Danish: Symptomerne på toksicitet er dyb sedation, ataksi, miosis, kramper samt respirationsdepression, som er det væsentligste symptom.
English: The arbitration procedure started on 24 January 2007 with the adoption of a list of questions.
Danish: Mængden af analgetikaforbrug i de forudgående 24 timer bestemmes.
English: 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.
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR ÆNDRING AF PRODUKTRESUMÉET (-RESUMÉERNE), ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMEA
English: The majority of these reactions were mild or moderate.
Danish: Størstedelen af disse reaktioner var lette eller moderate.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Revestive on 30 August 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Revestive den 30. august 2012.
English: Furthermore, Revestive showed an acceptable safety profile.
Danish: Desuden udviste Revestive en acceptabel sikkerhedsprofil.
English: If a benefit is not observed, treatment should be stopped.
Danish: Hvis der ikke iagttages gavnlig virkning, bør behandlingen ophøre.
English: The CHMP therefore concluded that Revestive's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede derfor, at fordelene ved Revestive er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: This is a summary of the European public assessment report (EPAR) for Revestive.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Revestive.
English: The company will provide more data about the medicine's safety from a registry of patients.
Danish: Virksomheden vil fremlægge yderligere data om lægemidlets sikkerhed fra et patientregister.
English: Other information about Revestive
Danish: Andre oplysninger om Revestive
English: Revestive teduglutide
Danish: Revestive teduglutid
English: What measures are being taken to ensure the safe and effective use of Revestive?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Revestive?
English: Why is Revestive approved?
Danish: Hvorfor blev Revestive godkendt?
English: It is not intended to provide practical advice on how to use Revestive.
Danish: Det er ikke en praktisk vejledning i, hvordan Revestive bør anvendes.
English: This compares with 30% (13 out of 43) of those given placebo (a dummy treatment).
Danish: Til sammenligning var tallet 30 % (13 ud af 43) af dem, der fik placebo (en virkningsløs behandling).
English: What is Revestive and what is it used for?
Danish: Hvad er Revestive, og hvad anvendes det til?
English: Revestive must not be used in patients who have, or are suspected to have, cancer.
Danish: Revestive må ikke anvendes hos patienter, der har eller formodes at have kræft.
English: Patients or their carers can inject the medicines once they have received adequate training.
Danish: Patienten eller omsorgsgiveren kan injicere lægemidlet efter at have fået passende oplæring.
English: Revestive contains the active substance teduglutide.
Danish: Revestive indeholder det aktive stof teduglutid.
English: 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
Danish: 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.
English: 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.
Danish: Lægemidlet udleveres kun efter recept, og behandlingen bør indledes under opsyn af en læge med erfaring i behandling af korttarmssyndrom.
English: 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.
Danish: 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.
English: The full EPAR for Revestive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Revestive findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What are the risks associated with Revestive?
Danish: Hvilke risici er der forbundet med Revestive?
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Revestive is given as an injection under the skin of the abdomen.
Danish: Revestive gives som en injektion under huden på maven.
English: Revestive has been shown in 2 studies to reduce the amount of parenteral nutrition that patients need.
Danish: Revestive er i to undersøgelser blevet påvist at mindske behovet for parenteral ernæring.
English: 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.
Danish: Det må ikke anvendes hos patienter, der har haft mave-tarmkræft eller leverkræft inden for de seneste fem år.
English: For more information about treatment with Revestive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: 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.
English: Studies show that Revestive is beneficial for patients with short bowel syndrome as it significantly reduces the amount of parenteral nutrition they need.
Danish: Undersøgelser viser, at Revestive er gavnligt for patienter med korttarmssyndrom, da det væsentligt mindsker behovet for parenteral ernæring.
English: 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.
Danish: 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.
English: Patients with short bowel syndrome are usually given nutrients as an infusion directly into their veins (parenteral nutrition).
Danish: Patienter med korttarmssyndrom får som regel tilført næringsstoffer i form af en infusion direkte i en vene (parenteral ernæring).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: What benefits of Revestive have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Revestive?
English: For practical information about using Revestive, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Revestive, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: 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.
Danish: Den anbefalede dosis er 0,05 mg pr. kg legemsvægt én gang dagligt.
English: How is Revestive used?
Danish: Hvordan anvendes Revestive?
English: Teduglutide has the advantage of lasting longer than GLP-2 in the body.
Danish: I forhold til GLP2 har teduglutid den fordel, at det forbliver længere tid i kroppen.
English: Revestive is a medicine for treating short bowel syndrome (or short gut) in adults and children aged 1 year and above.
Danish: Revestive er et lægemiddel, der anvendes til behandling af voksne og børn på 1 år og derover med korttarmssyndrom.
English: How does Revestive work?
Danish: Hvordan virker Revestive?
English: For the full list of all side effects reported with Revestive, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Revestive fremgår af indlægssedlen.
English: 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.
Danish: 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.
English: The final study report shall be submitted to the National Competent Authorities:
Danish: Den endelige undersøgelsesrapport forelægges de nationale kompetente myndigheder:
English: 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.
Danish: Oplysningsmaterialet skal sikre, at sundhedspersoner og patienter/omsorgsgivere er i stand til at gennemføre administrationen af produktet på grundlag af anvisningerne i produktinformationen.
English: The protocol shall be submitted to the National Competent Authorities:
Danish: Protokollen forelægges de nationale kompetente myndigheder:
English: 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.
Danish: 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.
English: National Competent Authorities of Member States or Reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Danish: De nationale kompetente myndigheder i medlemsstaterne eller i givet fald i referencemedlemsstaten (staterne) sikrer, at indehaverne af markedsføringstilladelse opfylder følgende betingelser:
English: 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).
Danish: Indehaverne af markedsføringstilladelse for adrenalin-autoinjektorer forelægger en risikostyringsplan for de nationale kompetente myndigheder.
English: Austria and Hungary
Danish: Østrig og Ungarn
English: The responses were submitted to the EMEA on 12 September 2006.
Danish: Besvarelserne blev indleveret til EMEA den 12. september 2006.
English: This study was not available to CMD(v).
Danish: Denne undersøgelse var ikke til rådighed for CMD(v).
English: Belgium, Czech Republic, Denmark, Spain, Finland, Italy, Luxembourg, The Netherlands, Norway, Poland and Slovakia
Danish: Belgien, Tjekkiet, Danmark, Spanien, Finland, Italien, Luxembourg, Nederlandene, Norge, Polen og Slovakiet
English: The variation between individual cows was 1-3 hours.
Danish: Variationen mellem de enkelte køer var 1-3 timer.
English: The recommended dose and treatment time must not be exceeded.
Danish: Den anbefalede dosis og behandlingstid må ikke overskrides.
English: Route of administration: Oral use.
Danish: Indgivelsesvej: Oral anvendelse.
English: The bioavailability after per-oral dosing is about 76 %.
Danish: Biotilgængeligheden efter oral indgift er ca. 76%.
English: MANUFACTURER'S BATCH NUMBER Batch
Danish: FREMSTILLERENS BATCHNUMMER Batch:
English: No such studies have been conducted with cattle.
Danish: Der er ikke udført forsøg af denne type med kvæg.
English: In cases of overdose symptomatic therapy should be given.
Danish: I tilfælde af overdosering behandles symptomatisk.
English: In Finland the product has been authorised for the indication: “The treatment of fever and inflammation in cattle”.
Danish: I Finland er produktet godkendt til indikationen "behandling af feber og inflammation hos kvæg."
English: Hands should be washed after the administration of the drug.
Danish: Hænderne bør vaskes efter håndtering af lægemidlet.
English: As above
Danish: Som ovenstående