FrancophonIA/ELRC3.0 huggingface dataset:
English: [EMEA/261645/2008] The Management Board endorsed the proposal for a pilot project that aims for greater involvement of patients and consumers in the work of the Agency.
Danish: [EMEA/261645/2008] Bestyrelsen godkendte forslaget til et pilotprojekt, der skulle fremme patienters og forbrugeres deltagelse i agenturets arbejde.
English: Additional documents tabled
Danish: Andre fremlagte dokumenter
English: Draft agenda for 4-5 March 2009 meeting [EMEA/MB/663707/2008] The agenda was adopted.
Danish: Forslag til dagsorden for mødet den 4.-5. marts 2009 [EMEA/MB/663707/2008] Dagsordenen blev vedtaget.
English: Preliminary draft budget 2010
Danish: Foreløbigt budgetforslag for 2010
English: [EMEA/MB/58755/2009] The Management Board also considered the potential financial and budgetary impact of the fee incentives proposed under MUMS/limited markets.
Danish: [EMEA/MB/58755/2009] Bestyrelsen drøftede også den potentielle finansielle og budgetmæssige indvirkning af gebyrincitamenterne, der var foreslået under MUMS/begrænsede markeder.
English: The main objectives of the intended new organisation include: integration of the human pre- and postauthorisation (line extensions and variations) procedures; more focus on safety-monitoring of medicines through separation of pharmacovigilance and of risk-management activities from postauthorisation work; creation of a new sector for data management.
Danish: Hovedformålet med den påtænkte strukturændring var følgende: integration af procedurerne for humanmedicinske lægemidler før og efter godkendelse (ændringer og udvidelser af produktserier), mere fokus på sikkerhedsovervågning af lægemidler ved at adskille lægemiddelovervågning og risikostyringsaktiviteter fra post-godkendelsesarbejdet samt oprettelse af en ny sektion for datastyring.
English: This work is part of the process-improvement work started in
Danish: Dette arbejde indgik i bestræbelserne på at forbedre processen, som blev iværksat i 2006.
English: [EMEA/103390/2009] The Management Board noted the ongoing discussion between the CHMP and the CAT regarding the CAT rules of procedure and the procedural advice on evaluation of ATMPs.
Danish: [EMEA/103390/2009] Bestyrelsen noterede sig de igangværende drøftelser mellem CHMP og CAT om CAT's forretningsorden og den proceduremæssige rådgivning om vurdering af ATMP'er.
English: The Management Board noted the report from the Heads of Medicines Agencies (HMA), which included: information on the election of Johannes Löwer as the new chair of the HMA management group, replacing Jytte Lyngvig; discussions regarding the EudraPharm database; resources of the network; work on antimicrobial resistance.
Danish: Den omfattede bl.a. information om valget af Johannes Löwer til ny formand for chefernes styringsgruppe, som trådte i stedet for Jytte Lyngvig, drøftelser om EudraPharm-databasen, netværkets ressourcer og arbejde med antimikrobiel resistens.
English: The Management Board noted the following documents for information: [EMEA/MB/30754/2009] Survey 2008 on the performance of EMEA scientific procedures for medicinal products for human use.
Danish: Bestyrelsen tog følgende dokumenter til orientering til efterretning: [EMEA/MB/30754/2009] Undersøgelse fra 2008 om resultaterne af EMEA's videnskabelige procedurer for humanmedicinske lægemidler.
English: Preliminary draft work programme 2010
Danish: Foreløbigt udkast til arbejdsprogram for 2010
English: The year 2008 saw a further growth in the volume of core activities.
Danish: Der havde været en yderligere vækst i hovedaktiviteternes omfang.
English: [EMEA/MB/81661/2009] Outcome of written procedures on consultation on changes in the membership of the CHMP and CVMP committees.
Danish: [EMEA/MB/81661/2009] Resultat af de skriftlige procedurer vedrørende høring om ændringer i medlemskabet af CHMP- og CVMP-udvalgene.
English: Minutes from the 61st meeting, 11 December 2008 [EMEA/MB/671250/2008] The Management Board noted the outcome of the written procedure.
Danish: møde den 11. december 2008 [EMEA/MB/671250/2008] Bestyrelsen noterede sig resultatet af den skriftlige procedure.
English: Points for information
Danish: Punkter til orientering
English: [EMEA/MB/649766/2008] Summary of transfers of appropriations in the budget, 2008 and 2009.
Danish: [EMEA/MB/649766/2008] Sammendrag af bevillingsoverførsler på budgettet for 2008 og 2009.
English: [EMEA/118727/2009] The Management Board considered the present state of the discussion on whether the CHMP also has to endorse milestone documents relating to the evaluation of ATMPs.
Danish: [EMEA/118727/2009] Bestyrelsen noterede sig drøftelsen om, hvorvidt CHMP også skulle godkende milepælsdokumenter i relation til vurderingen af ATMP'er.
English: Start of the term of office of the Management Board members nominated by the Council [EMEA/MB/87076/2009] The Management Board adopted the decision whereby the term of office of the four members of the Management Board listed in Article 1 of Council Decision No 2009/75/EC commenced on 5 March 2009.
Danish: [EMEA/MB/87076/2009] Bestyrelsen vedtog beslutningen om, at mandatperioden for de fire medlemmer af bestyrelsen, jf. artikel 1 i Rådets afgørelse nr. 2009/75/EF, skulle begynde den 5. marts
English: Election of the Management Board Vice-chair [EMEA/MB/81623/2009] The Management Board elected Mrs Lisette Tiddens-Engwirda as Vicechair with the following votes: Sole round - 34 votes Lisette Tiddens-Engwirda
Danish: Valg af næstformand til bestyrelsen [EMEA/MB/81623/2009] Bestyrelsen valgte Lisette Tiddens-Engwirda til næstformand med følgende stemmer:
English: [EMEA/CHMP/89672/2009] The Management Board supported the proposed amendments to the rules of procedure of the CHMP.
Danish: [EMEA/CHMP/89672/2009] Bestyrelsen tilsluttede sig de foreslåede ændringer af CHMP's forretningsorden.
English: − The Committee for Advanced Therapies (CAT)
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) Udvalget for Avancerede Terapier (CAT)
English: 5 March 2009 meeting
Danish: Mødet den 5. marts 2009
English: [EMEA/MB/684002/2008] The Management Board heard a presentation on the implementation of the 2008 work programme.
Danish: [EMEA/MB/684002/2008] Bestyrelsen fik en præsentation af gennemførelsen af arbejdsprogrammet for 2008.
English: 4 March 2009
Danish: 4. marts 2009
English: The European Commission representative requested the Board in the future, to allow that the draft establishment plan be submitted to the Directorate-General for Industry and Enterprise, the Directorate-General for Personnel and Administration and the Directorate-General for Budget ahead of the March Management Board meetings in order to allow the Commission to produce its consolidated opinion on the draft plan.
Danish: Personale og Administration og Generaldirektoratet for Budget før bestyrelsens møder i marts, således at Kommissionen kunne udarbejde sin konsoliderede udtalelse om udkastet.
English: − Preliminary draft budget and establishment plan
Danish: Foreløbigt udkast til arbejdsprogram Foreløbigt budgetforslag og stillingsfortegnelse Udkast til plan for personalepolitikken
English: EMEA/MB/144834/2009/EN/Adopted
Danish: EMEA/MB/94586/2009
English: [EMEA/MB/67287/2009] The Management Board endorsed the proposed amendment under paragraph 4.1.4 (MRL applications, including extrapolations) of the procedural advice for classification and incentives for veterinary medicinal products indicated for minor uses and minor species (MUMS)/limited markets.
Danish: 4.1.4 (MRLansøgninger, herunder ekstrapoleringer) af rådgivningen vedrørende klassifikationer og incitamenter til veterinærlægemidler til mindre udbredte sygdomme og mindre arter (MUMS)/begrænsede markeder.
English: [EMEA/86607/2009; EMEA/MB/45112/2009] Reports on EudraVigilance implementation for human medicines and medicines for veterinary use.
Danish: [EMEA/MB/20870/2009] Ajourført rapport om EMEA's gennemførelse af EU's telematikstrategi [EMEA/86607/2009, EMEA/MB/45112/2009] Rapporter om gennemførelsen af EudraVigilance for humanmedicinske og veterinærmedicinske lægemidler.
English: [EMEA/MB/673201/2008] The Management Board adopted the proposed mandate of the task force, with a deletion of Point 4, relating to future legislative changes.
Danish: [EMEA/MB/673201/2008] Bestyrelsen vedtog det foreslåede mandat for taskforcen, idet pkt.
English: Minutes of the sixty-second meeting of the Management Board
Danish: Deltagerliste for det 62.
English: [EMEA/MB/632200/2008; EMEA/MB/502942/2008; EMEA/MB/94586/2009; EMEA/MB/579221/ 2008] The Management Board adopted the preliminary draft work programme, budget and staff-policy plan for 2010.
Danish: EMEA/MB/579221/ 2008] Bestyrelsen vedtog det foreløbige udkast til arbejdsprogram, det foreløbige budgetforslag og udkastet til plan for personalepolitikken for 2010.
English: Lenka Balážová
Danish: Den Tjekkiske Republik Lenka Balážová Danmark
English: In rare cases, the animal may collapse.
Danish: I sjældne tilfælde kan dyret kollapse.
English: The product may be stored at 25 °C for 24 hours maximum.
Danish: Produktet kan opbevares ved 25 °C i højst 24 timer.
English: Arginine.
Danish: Arginin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/12/2015
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 09/12/2015
English: There is no known antidote.
Danish: Der findes ingen kendt antidot.
English: Bovine No MRL required
Danish: Bovin Ingen MRL påkræv et
English: ATCvet code: QL03AA90
Danish: ATCvet-kode: QL03AA90
English: Store in original packaging.
Danish: Opbevares i den originale pakning.
English: Sensitive to light.
Danish: Beskyttes mod lys.
English: Arginine hydrochloride.
Danish: Argininhydrochlorid.
English: The intervals between the two administrations should not be less than 3 days or more than 17 days.
Danish: Intervallet mellem de to injektioner skal være mindst 3 dage og højst 17 dage.
English: Biological/ Immunomodulat or
Danish: Biologisk/Immuno modulator
English: Do not exceed the stated dose.
Danish: Giv ikke mere end den angivne dosis.
English: Symptomatic treatment may be required.
Danish: Symptomatisk behandling kan være nødvendig.
English: The product should only be used on the basis of a positive benefit: risk assessment performed at the herd level by the responsible veterinarian.
Danish: Produktet må kun anvendes på basis af en positiv benefit-risk vurdering udført på besætningsniveau af den ansvarlige dyrlæge.
English: A single syringe delivers a dose of 20-40 µg/kg pegbovigrastim for most cows depending on bodyweight: e.g. a dose of 21 µg/kg bodyweight for a 700 kg cow or 33 µg/kg bodyweight for a 450 kg heifer.
Danish: En enkelt sprøjte giver en dosis på 20-40 µg/kg pegbovigrastim til de fleste køer afhængigt af kropsvægt: f.eks. en dosis på 21 µg/kg kropsvægt til en ko på 700 kg eller 33 µg/kg kropsvægt til en kvie på 450 kg.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and on the pre-filled syringe.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på æsken og den fyldte sprøjte.
English: During this EU study, 312 cows were treated with Imrestor for every 10 cases of clinical mastitis that were prevented during the periparturient period.
Danish: Under dette EU-studie blev 312 køer behandlet med Imrestor for hver 10 tilfælde af klinisk mastitis, som blev forebygget i perioden umiddelbart efter kælvning.
English: These clinical signs typically appear between 30 minutes and 2 hours after the first dose and resolve within 2 hours.
Danish: Disse kliniske tegn forekommer typisk mellem 30 minutter og 2 timer efter den første dosis og forsvinder i løbet af 2 timer.
English: Treatment should be symptomatic.
Danish: Behandling bør være symptomatisk.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/193/001-003
Danish: EU/2/15/193/001-003
English: Concurrent use of such products should be avoided.
Danish: Samtidig anvendelse af sådanne lægemidler bør undgås.
English: Shelf -life after first opening the immediate packaging: use immediately.
Danish: Opbevaringstid efter første åbning af den indre emballage: anvendes straks.
English: Only for subcutaneous administration.
Danish: Kun til subkutan administration.
English: The solution should be visually inspected prior to use.
Danish: Opløsningen skal kontrolleres visuelt inden brug.
English: The efficacy was tested together with normal management practice.
Danish: Effekten blev testet under normale management forhold.
English: It has also been proved that it enhances myeloperoxidase hydrogen peroxide halide mediated microbiocidal capabilities of neutrophils.
Danish: Det er også påvist, at det fremmer myeloperoxidases hydrogenperoxid-halid medierede mikrobiocide egenskaber hos neutrofile granulocytter.
English: Pharmacotherapeutic group: Colony stimulating factors.
Danish: Farmakoterapeutisk gruppe: Kolonistimulerende faktorer.
English: Do not mix with other veterinary medicinal products.
Danish: Må ikke blandes med andre lægemidler til dyr.
English: Available in boxes of 10, 50 or 100 syringes.
Danish: Leveres i æsker med 10, 50 eller 100 sprøjter.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.7 ml pre-filled syringe contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldt 2,7 ml injektionssprøjte indeholder:
English: The active substance in Imrestor 15 mg solution for injection for cattle is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Den aktive substans i Imrestor 15 mg injektionsvæske, opløsning til kvæg er en godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010: Farmakologisk aktive stof
English: Pregnancy and lactation: Can be used in pregnancy and lactation
Danish: Drægtighed og laktation: Kan anvendes under drægtighed og laktation
English: Remove gloves and wash hands and exposed skin after use.
Danish: Fjern handskerne og vask hænder og udsat hud efter brug.
English: Personal protective equipment consisting of gloves should be worn when handling broken or damaged syringes.
Danish: Personligt beskyttelsesudstyr i form af handsker bør anvendes ved håndtering af knuste eller beskadigede sprøjter.
English: STATEMENT OF ACTIVE SUBSTANCES Each 2.7 ml pre-filled syringe contains 15 mg pegbovigrastim.
Danish: ANGIVELSE AF AKTIVE STOFFER Hver fyldt 2,7 ml sprøjte indeholder 15 mg pegbovigrastim.
English: The syringes are packed into cardboard boxes as follows;
Danish: Sprøjterne er pakket i papæsker som følger:
English: The product increases the number of circulating neutrophils.
Danish: Veterinærlægemidlet øger antallet af cirkulerende neutrofile granulocytter.
English: bG-CSF presents additional functions beyond its action on neutrophils and these may be direct or indirect functions on other cells/receptors and cytokine pathways.
Danish: bG-CSF udviser yderligere aktiviteter udover dets virkning på neutrofile granulocytter, og disse aktiviteter kan være direkte eller indirekte påvirkning af andre celler/receptorer og cytokin-signalveje.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: In a European field trial, the incidence of clinical mastitis observed in the treated group was 9.1 % (113/1235) and in the control group 12.4 % (152/1230), showing a relative reduction in mastitis incidence of 26.0 % (p=0.0094).
Danish: I et europæisk feltstudie blev forekomsten af klinisk mastitis observeret hos den behandlede gruppe 9,1 % (113/1235) og hos kontrolgrouppen 12,4 % (152/1230), og det viste en relativ reduktion i forekomsten af mastitis på 26,0 % (p = 0,0094).
English: Imrestor 15 mg injection pegbovigrastim
Danish: Imrestor 15 mg injektion pegbovigrastim
English: Milk: zero days.
Danish: Mælk: nul dage.
English: Remove gloves and wash hands and exposed skin and after use.
Danish: Fjern handskerne og vask hænder og eksponeret hud efter brug.
English: Subcutaneous administration of the product may induce transient local swelling at the injection site as well as inflammatory reactions which resolve within 14 days post treatment.
Danish: Subkutan administration af produktet kan fremkalde forbigående lokal hævelse på injektionsstedet samt inflammatoriske reaktioner, som forsvinder inden for 14 dage efter behandling.
English: The treatment regimen consists of two syringes.
Danish: Behandlingsregimet består af to injektioner.
English: In animals, which have pharmaceutically altered immune function e.g. those which have recently received systemically administered corticosteroids or non-steroidal anti-inflammatory drugs the product may not be effective.
Danish: Hos dyr, som har en farmaceutisk ændret immunfunktion f.eks. dyr, som for nylig har fået systemisk indgivet kortikosteroider eller non-steroide anti-inflammatoriske lægemidler, er veterinærlægemidlet muligvis ikke effektivt.
English: Manufacturer for the batch release: Elanco Speke Operations Fleming Road
Danish: Fremstiller ansvarlig for batchfrigivelse: Elanco Speke Operations Fleming Road
English: PACKAGE SIZE 10 pre-filled syringes 50 pre-filled syringes 100 pre-filled syringes
Danish: PAKNINGSSTØRRELSE 10 fyldte sprøjter 50 fyldte sprøjter 100 fyldte sprøjter
English: Only for subcutaneous injection.
Danish: Til subkutan injektion.
English: In the case of accidental self-injection, headache and bone and muscle pain may occur.
Danish: I tilfælde af utilsigtet selvinjektion kan der forekomme hovedpine og knogle- og muskelsmerter.
English: The efficacy was tested alongside normal dairy herd management practices.
Danish: Effekten blev testet side om side med normal behandlingspraksis for malkekøer.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger) - Almindelige (flere end 1, men færre end 10 ud af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: As an aid in a herd management programme, to reduce the risk of clinical mastitis in periparturient dairy cows and heifers during the 30 days following calving.
Danish: Som en hjælp i et behandlingsprogram i malkekvægsbesætninger til at reducere risikoen for klinisk mastitis hos malkekvæg og kvier i perioden omkring og op til 30 dage efter kælvning.
English: The immunoregulatory activities of granulocyte colony stimulating factor concerns notably cells of the neutrophilic granulocyte lineage which bear cell surface receptors for the protein.
Danish: De immunregulerende aktiviteter hos granulocyt-kolonistimulerende faktor vedrører navnligt celler fra den neutrofile granulocyt cellelinje, som bærer celleoverfladereceptorer til proteinet.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) The product is a clear, colourless to pale yellow solution for injection containing 15 mg pegbovigrastim (pegylated bovine colony stimulating factor) in a pre-filled syringe.
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Veterinærlægemidlet er en klar, farveløs til lysegul opløsning til injektion, som indeholder 15 mg pegbovigrastim (pegyleret bovin granulocyt-kolonistimulerende faktor) i en fyldt sprøjte.
English: The content of a single pre-filled syringe is to be injected subcutaneously to a dairy cow/heifer 7 days before the anticipated date of calving.
Danish: Indholdet af en enkelt fyldt sprøjte skal injiceres subkutant i en malkeko/kvie 7 dage før den forventede kælvningsdag.
English: Meat and offal: zero days Milk: zero days
Danish: Slagtning: nul dage Mælk: nul dage
English: 4.7 Use during pregnancy and lactation
Danish: 4.7 Anvendelse under drægtighed, laktation eller æglægning
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cartons of 10, 50 or 100 syringes
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æsker med 10, 50 eller 100 sprøjter
English: 2.7 ml of solution for injection in a pre-filled polypropylene colourless syringe with siliconised chlorobutyl stopper and a stainless steel needle with needle guard.
Danish: 2,7 ml opløsning til injektion i en fyldt, farveløs sprøjte af polypropylen med silikoniseret chlorobutylprop og en kanyle i rustfrit stål med kanylehætte.
English: Excessive shaking of the syringe may aggregate pegbovigrastim reducing its biological activity: The solution should be visually inspected prior to use.
Danish: Voldsom omrystning af sprøjten kan medføre, at pegbovigrastim danner klumper, hvilket nedsætter dets biologiske aktivitet: Opløsningen skal kontrolleres visuelt inden brug.
English: Excessive shaking of the syringe may aggregate pegbovigrastim, reducing its biological activity.
Danish: Voldsom omrystning af sprøjten kan medføre, at pegbovigrastim aggregerer, hvilket reducerer dets biologiske aktivitet.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf, bør destrueres i henhold til lokale retningslinjer.
English: In the clinical studies, non-typical anaphylactoid reactions were uncommonly observed.
Danish: I kliniske studier var ikke-typiske anafylaktoide reaktioner ikke almindelig.
English: Disposal: read package leaflet
Danish: Bortskaffelse: læs indlægssedlen
English: During the clinical field studies, non typical anaphylactoid type reactions were uncommonly observed.
Danish: Under de kliniske feltstudier var ikke-typiske anafylaktoide reaktioner ikke almindelig.
English: Seek medical advice immediately and show the package leaflet to the physician.
Danish: Søg straks lægehjælp og vis indlægssedlen til lægen.
English: Based on all field studies, the proportion of mastitis prevented due to herd treatment with Imrestor (Prevented Fraction) is 0.25 (with 95% confidence interval 0.14 - 0.35).
Danish: Baseret på alle feltstudier er proportionen af mastitis forebygget ved behandling af hele besætningen med Imrestor (ætiologisk fraktion) 0,25 (med 95 % konfidensinterval 0,14-0,35).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 2.7 ml pre-filled syringe
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER 2,7 ml fyldt sprøjte
English: No information is available with regard to a possible immune reaction towards the product or towards the endogenous molecule (bG-CSF) after repeated use of the product in cows.
Danish: Der foreligger ingen oplysninger med hensyn til en mulig immunreaktion over for produktet eller over for det endogene molekyle (bG-CSF) efter gentagen brug af produktet hos køer.
English: Seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Der skal omgående søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: If you notice any serious effects or other effects not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Danish: Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.