FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Daliresp - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Daliresp - hvis du er allergisk over for roflumilast eller et af de øvrige indholdsstoffer i Daliresp (angivet i afsnit 6).
English: Daliresp has no influence on the ability to drive and use machines.
Danish: Daliresp påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Daliresp is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms).
Danish: Daliresp er ikke beregnet til behandling af et pludseligt anfald af åndenød (akutte bronkospasmer).
English: Frequency System Organ Class
Danish: Systemorganklasser
English: What Daliresp contains - The active substance is roflumilast.
Danish: Daliresp indeholder: - Det aktive stof er roflumilast.
English: •Obligation to conduct post-authorisation measures
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: Daliresp may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators.
Danish: Daliresp kan tages sammen med andre lægemidler, der anvendes til behandling af KOL såsom inhalerede eller orale steroider eller bronkodilatatorer.
English: The potential cardiac risk: Daliresphas not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Danish: Den potentielle kardielle risiko: Daliresper ikke undersøgt hos patienter med kongestiv hjerteinsufficiens (NYHA grad 3 og 4) og derfor ikke anbefales til denne population.
English: If you stop taking Daliresp
Danish: Hvis du holder op med at tage Daliresp
English: The effect of Daliresp may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy).
Danish: Virkningen af Daliresp kan forringes, hvis det tages sammen med rifampicin (antibiotika) eller sammen med fenobarbital, karbamazepin eller fenytoin (medicin der normalt gives til behandling af epilepsi).
English: If you forget to take Daliresp
Danish: Hvis du har glemt at tage Daliresp
English: Daliresp is to be used in addition to bronchodilators.
Danish: Daliresp skal anvendes som tillæg til bronkodilatatorer.
English: In case of an allergic reaction, stop taking Daliresp and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital.
Danish: Hvis du får en allergisk reaktion, skal du stoppe med at tage Daliresp og straks kontakte læge eller skadestue.
English: Daliresp is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.
Danish: Daliresp anvendes til vedligeholdelsesbehandling af svær KOL hos voksne, der tidligere har haft hyppige forværringer af symptomerne på sygdommen KOL (dette kaldes eksacerbationer), og som lider af kronisk bronkitis.
English: Treatment with roflumilast may lead to a higher risk of sleep disorders (mainly insomnia) in patients with a baseline body weight of <60 kg, due to a higher total PDE4 inhibitory activity found in these patients (see section 4.8).
Danish: Behandling med roflumilast kan medføre en større risiko for søvnforstyrrelser (hovedsageligt søvnløshed) hos patienter med en kropsvægt < 60 kg ved baseline på grund af en højere samlet PDE4hæmmende aktivitet, som er konstateret hos disse patienter (se pkt.
English: Daliresp contains Lactose
Danish: Daliresp indeholder lactose
English: Both roflumilast and roflumilast N-oxide have intrinsic phosphodiesterase 4 (PDE4) inhibitory activity.
Danish: Både roflumilast og roflumilast N-oxid har intrinsic phosphodiesterase-4(PDE4)-hæmmende aktivitet.
English: If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low blood pressure.
Danish: Hvis du har taget for mange Daliresp tabletter Hvis du har taget flere tabletter, end du skulle, kan du opleve følgende symptomer: hovedpine, kvalme, diare, svimmelhed, hjertebanken, uklarhed, klamsved og lavt blodtryk.
English: These findings consisted mainly of gastrointestinal findings (i.e. vomiting, increased gastric secretion, gastric erosions, intestine inflammation) and cardiac findings (i.e. focal haemorrhages, haemosiderin deposits and lympho-histiocytic cell infiltration in the right atria in dogs, and decreased blood pressure and increased heart rate in rats, guinea pigs and dogs).
Danish: Disse fund bestod hovedsageligt af gastrointestinale fund (dvs. opkastning, øget gastrisk sekretion, gastriske erosioner, tarmbetændelse) og kardielle fund (dvs. fokale blødninger, hæmosiderinaflejringer og infiltration af lymfocytter og histiocytter i højre atrium hos hund, og nedsat blodtryk og øget hjertefrekvens i rotte, marsvin og hund).
English: Daliresp contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Danish: Daliresp indeholder det aktive stof roflumilast, som er et anti-inflammatorisk lægemiddel, der kaldes fosfodiesterase 4-hæmmer.
English: Analysis
Danish: Analysemodel
English: Rescue medicinal products Daliresp is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Danish: Anfaldsmedicin Daliresp er ikke indiceret som anfaldsmedicin til lindring af akutte bronkospasmer.
English: You may experience diarrhoea, nausea, stomach ache or headache during the first weeks of treatment with Daliresp.
Danish: Du kan måske opleve diare, kvalme, mavesmerter eller hovedpine i løbet af de første uger af behandlingen med Daliresp.
English: Other medicines and Daliresp
Danish: Brug af anden medicin sammen med Daliresp
English: Hypromellose Macrogol 4000 Titanium dioxide (E171) Iron oxide yellow (E172)
Danish: Filmovertræk: Hypromellose, Macrogol 4000, titandioxid (E171), gul jernoxid (E172)
English: If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended todiscontinue treatment with Daliresp.
Danish: Hvis patienten får nye psykiske symptomer eller de forværres, eller hvis selvmordstanker ellerforsøg opdages, anbefales det at afbryde behandling med Daliresp.
English: Daliresp 500 micrograms
Danish: Daliresp 500 mikrogram
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g.multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Dalirespshould not be initiated or should be stopped in these patients.
Danish: Den manglende erfaring hos patienter med HIV-infektion eller aktiv hepatitis, med alvorlige immunologiske sygdomme (multipel sklerose, lupus erythematosus, multifokal leukoenkefalopati) eller patienter i immunsupprimerende behandling (andre end korttids-systemiske kortikosteroider).
English: Daliresp is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Danish: Daliresper kontraindiceret til patienter med moderat eller svær nedsat leverfunktion (Child-Pugh B eller
English: 2 What you need to know before you take Daliresp
Danish: Det skal du vide, før du begynder at tage Daliresp
English: Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
Danish: Daliresp anvendes som vedligeholdelsesbehandling hos voksne patienter med svær, kronisk obstruktiv lungesygdom (KOL) (FEV1 efter bronkodilatation mindre end 50% af forventet) associeret med kronisk bronkitis og med tidligere gentagne eksacerbationer.
English: All patients should be informed about the risks of Daliresp and the precautions for safe use and should be given a patient card before starting Daliresp.
Danish: Alle patienter skal informeres om risici forbundet med behandling med Daliresp og om forholdsregler for sikkert brug.
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daliresp (see section 4.3).
Danish: Patienter med moderat eller svært nedsat leverfunktion klassificeret som Child-Pugh B eller C må ikke tage Daliresp (se pkt.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially the following: - a medicine containing theophylline (a medicine to treat respiratory diseases), or - a medicine used for treatment of immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term.
Danish: Fortæl det til lægen, før du begynder at tage Daliresp, hvis du allerede tager: - medicin, der indeholder theofyllin (medicin til behandling af luftvejssygdomme), eller - medicin, der bruges til behandling af immunologiske sygdomme, som methotrexat, azathioprin,
English: What Daliresp looks like and contents of the pack Daliresp 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Danish: Daliresp 500 mikrogram filmovertrukne tabletter er gule, D-formede filmovertrukne tabletter, mærket med ”D” på den ene side.
English: EU/1/11/668/001 EU/1/11/668/002 EU/1/11/668/003
Danish: EU/1/11/668/002
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Daliresp tabletter indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (lapp lactase deficiency) eller glucose/galactose malabsorption.
English: Daliresp is not recommended in patients with a history of depression associated with suicidal thinking or behaviour.
Danish: Daliresp anbefales ikke til patienter, der tidligere har haft depression forbundet med selvmordstanker eller selvmordslignende adfærd.
English: Driving and using machines Daliresp has no influence on the ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Daliresp påvirker ikke arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.
English: (LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function
Danish: Daliresp anbefales ikke, hvis du har en eller flere af følgende sygdomme: - svære immunologiske sygdomme som HIV-infektion, multipel sklerose (MS), lupus erythematosus (LE) eller progressiv multifokal leukoenkefalopati, (PML) - alvorlige akutte infektionssygdomme som tuberkulose eller akut hepatitis - kræft (bortset fra basalcellekarcinom, en langsomt voksende form for hudkræft) - eller alvorlig forringelse af hjertefunktionen.
English: 3 How to take Daliresp
Danish: Sådan skal du tage Daliresp
English: The clinical data with Daliresp in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daliresp should be used with caution in these patients.
Danish: De kliniske data for patienter med let nedsat leverfunktion klassificeret som Child-Pugh A, og som blev behandlet med Daliresp, er utilstrækkelige til at anbefale en dosisjustering (se pkt.
English: What Daliresp is and what it is used for What you need to know before you take Daliresp How to take Daliresp
Danish: Det skal du vide, før du begynder at tage Daliresp Sådan skal du tage Daliresp Bivirkninger
English: Laboratorio Tau, S.A. Tel: +34 91 301 91 00
Danish: Tel: +34 91 301 91 00
English: Daliresp 500 micrograms tablets roflumilast
Danish: Daliresp 500 mikrogram tabletter roflumilast
English: Daliresp 500 micrograms film-coated tablets roflumilast
Danish: Daliresp 500 mikrogram filmovertrukne tabletter Roflumilast
English: Daliresp 500 micrograms film-coated tablets Roflumilast
Danish: Daliresp 500 mikrogram filmovertrukne tabletter roflumilast
English: Daliresp 500 micrograms film-coated tablets
Danish: Daliresp 500 mikrogram filmovertrukne tabletter
English: The educational pack should contain the following: • Summary of Product Characteristics and Patient Information Leaflet for Daliresp
Danish: • Produktresumé og indlægsseddel for Daliresp.
English: It can request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Danish: Virksomheden kan anmode om, at udtalelsen tages op til fornyet overvejelse inden for 15 dage efter modtagelsen af underretningen om denne negative udtalelse.
English: This means that it was intended to be similar to a biological medicine (the ‘reference medicine') already authorised in the European Union (EU).
Danish: Det vil sige, at det var hensigten, at Solumarv skulle svare til et biologisk lægemiddel ("referencelægemidlet"), som allerede er godkendt i Den Europæiske Union (EU).
English: The company that applied for authorisation is Marvel Lifesciences Ltd.
Danish: Den virksomhed, der har ansøgt om godkendelse, er Marvel Lifesciences Ltd.
English: The CHMP's main concern was that the company did not define the manufacturing process for Solumarv in sufficient detail.
Danish: CHMP's vigtigste betænkeligheder bestod i, at virksomheden ikke har beskrevet fremstillingsprocessen for Solumarv i tilstrækkelige detaljer.
English: On 19 November 2015, the Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorisation for the medicinal product Solumarv, intended for the treatment of diabetes.
Danish: Den 19. november 2015 anbefalede Udvalget for Lægemidler til Mennesker (CHMP) afslag på ansøgningen om markedsføringstilladelse for lægemidlet Solumarv, der er beregnet til behandling af sukkersyge.
English: Two additional studies in patients with type 1 and type 2 diabetes compared the safety and effectiveness of Solumarv and Humulin S.
Danish: Der blev udført to supplerende undersøgelser hos patienter med type 1- og type 2sukkersyge til sammenligning af sikkerheden og virkningen af Solumarv og Humulin S.
English: Solumarv is a medicine that contains the active substance human insulin.
Danish: Solumarv er et lægemiddel, der indeholder det aktive stof humant insulin.
English: Refusal of the marketing authorisation for Solumarv (insulin human)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Solumarv (humant insulin)
English: Solumarv was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels.
Danish: Solumarv forventedes anvendt til behandling af patienter med sukkersyge, som behøver insulin til regulering af blodsukkeret.
English: The CHMP concluded that Solumarv could not be approved as a biosimilar of Humulin S and recommended that it be refused marketing authorisation.
Danish: CHMP konkluderede, at det ikke kunne godkendes, at Solumarv er biosimilært til Humulin S, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: Diabetes is a condition in which the body does not produce enough insulin to control the level of blood sugar or in which the body is unable to use insulin effectively.
Danish: Ved sukkersyge producerer bugspytkirtlen ikke nok insulin til at regulere blodsukkeret, eller også er kroppen ikke i stand til at udnytte insulinet effektivt.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 November 2015 EMA/765377/2015 EMEA/H/C/003858
Danish: Den 20. november 2015 EMA/861025/2015 EMEA/H/C/003858
English: Refusal of the marketing authorisation for Solumarv (insulin human) EMA/765377/2015
Danish: Afslag på ansøgningen om markedsføringstilladelse for Solumarv (humant insulin) EMA/861025/2015
English: The company presented results of studies in healthy people designed to show that Solumarv is similar to its reference medicine Humulin S in terms of biological activity and how the body handles the medicine.
Danish: Virksomheden fremlagde resultaterne af undersøgelser hos raske personer for at vise, at Solumarv svarer til referencelægemidlet Humulin S hvad angår den biologiske aktivitet og kroppens håndtering af lægemidlet.
English: As such, it was not possible to show that Solumarv used in clinical studies was representative of batches intended for the market and that its quality was comparable to Humulin S's.
Danish: Det kunne derfor ikke påvises, at det Solumarv, der er anvendt i de kliniske undersøgelser, svarede til de batcher, der er beregnet til markedsføring, eller at dets kvalitet var sammenlignelig med kvaliteten af Humulin S.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes affected by the Committee's opinion.
Danish: Virksomheden har til CHMP oplyst, at der ikke er undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse, der berøres af udvalgets udtalelse.
English: Solumarv was intended as a replacement for the insulin made by the body.
Danish: Det var hensigten, at Solumarv skulle være en erstatning for det insulin, der produceres af kroppen.
English: It was to be available as a solution for injection.
Danish: Det var meningen, at det skulle kunne fås som injektionsvæske, opløsning.
English: These differences are also expected to occur in practice;
Danish: Disse forskelle forventes også at forekomme i praksis.
English: In this way, 13 formulation groups were established.
Danish: På denne måde blev der fastlagt 13 formuleringsgrupper.
English: Number of products
Danish: Antal produkter
English: Not for use in animals producing milk for human consumption.
Danish: Må ikke bruges til dyr, der producerer mælk, som anvendes til menneskeføde.
English: Centurii, nr. 7, Voluntari Romania
Danish: Centurii, nr. 7, Voluntari Rumænien
English: The studies were well-conducted and comprised a considerable number of slaughter time points.
Danish: Undersøgelserne var velgennemførte og omfattede et betydeligt antal tidspunkter i forbindelse med slagtning.
English: Formulation Group
Danish: Formuleringsgruppe
English: A safety span of 10% was considered appropriate as the studies were large and robust.
Danish: En sikkerhedsmargin på 10 % blev anset for at være passende, da undersøgelserne var store og af god kvalitet.
English: Number of acceptable residue depletion studies
Danish: Antal acceptable restkoncentrationsundersøgelser
English: Formulation groups allocated for the 293 products that are the subject of this referral.
Danish: Formuleringsgrupper for de 293 produkter, der er genstand for denne procedure.
English: Marketing Authorisation Holder and address
Danish: Indehaver af markedsføringstilladelsen og adresse
English: The United Kingdom expressed concerns that the difference in withdrawal periods established across the European Union for the relevant products may present a potential serious risk to human health, and requested the Committee for Medicinal Products for Veterinary Use (CVMP) to give its opinion on the matter.
Danish: Det Forenede Kongerige udtrykte bekymring for, at den forskel i tilbageholdelsestiden, der er fastlagt for de relevante produkter på tværs af EU, kan udgøre en potentiel alvorlig risiko for menneskers sundhed, og anmodede Udvalget for Veterinærlægemidler (CVMP) om at afgive udtalelse herom.
English: The individual withdrawal periods calculated by the CVMP ranged from 21 days to 78 days.
Danish: De individuelle tilbageholdelsestider beregnet af CVMP varierede fra 21 dage til 78 dage.
English: On the other hand, there is no scientific rationale to explain why withdrawal periods for formulations that are the same or essentially the same, should be different.
Danish: Der er på den anden side intet videnskabeligt rationale, der kan forklare, hvorfor tilbageholdelsestider for formuleringer, der er ens eller ens i det væsentlige, skal være forskellige.
English: In fact, a small and pharmacologically insignificant difference in absorbed fraction (e.g. 99.5% versus 99.9%) at a certain time point may imply a significant difference in the amount remaining in the injection site (a factor of 5 in this example).
Danish: En lille og farmakologisk uvæsentlig forskel i den absorberede fraktion (f.eks. 99,5 % i forhold til 99,9 %) på et bestemt tidspunkt kan f.eks. indikere en væsentlig forskel i den resterende mængde på injektionsstedet (en faktor på fem i dette eksempel).
English: Each group contained products considered to be essentially the same, in formulation terms.
Danish: Hver gruppe indeholdt produkter, der anses for at være ens i det væsentlige, hvad angår formulering.
English: Such an effect has been shown in experimental studies performed by a number of different groups (Lo et al., 19853; Wicks et al., 19934; Lifschitz et al. 19995, Lifschitz et al., 20046).
Danish: En sådan virkning er påvist i eksperimentelle undersøgelser udført af en række forskellige grupper (Lo et al., 19853, Wicks et al.4, 1993, Lifschitz et al. 19995, Lifschitz et al., 20046).
English: Ceva-Phylaxia Oltóanyagtermelő Zrt.
Danish: Ungarn Ceva-Phylaxia Oltóanyagtermelő Zrt.
English: Ivermectin was previously evaluated by the CVMP in order to establish maximum residue limits (MRLs).
Danish: Ivermectin har tidligere været vurderet af CVMP med henblik på fastsættelse af maksimalgrænseværdier for restkoncentrationer (MRL-værdier).
English: Merial Norden A/S Mileparken 20 E 2740 Skovlunde Denmark
Danish: Danmark Merial Norden A/S Mileparken 20 E 2740 Skovlunde Denmark
English: No suitable data
Danish: Ingen egnede data
English: However, the Committee considered that the use of the alternative approach (first time point below the ADI plus safety span) would insufficiently take account of the substantial amount of data (280 data points) available in this particular case.
Danish: Udvalget fandt dog, at brugen af den alternative metode (første tidspunkt under ADI-værdien plus sikkerhedsmargen) ikke i tilstrækkelig grad ville tage højde for den væsentlige datamængde (280 datapunkter), der var tilgængelig i dette særlige tilfælde.
English: For the purposes of this referral, that means that the withdrawal periods for all products in a single formulation group should be the same.
Danish: I forbindelse med denne procedure betyder det, at tilbageholdelsestiderne for alle produkter i en formuleringsgruppe skal være de samme.
English: It was noted that some of the studies were identical but were submitted by different MAHs.
Danish: Det blev bemærket, at nogle af undersøgelserne var identiske, men var blevet indgivet af forskellige indehavere af markedsføringstilladelser.
English: Using the alternative approach and applying safety span of 10% a withdrawal period of 66 days was derived.
Danish: Ved hjælp af en alternativ strategi og med en sikkerhedsmargin på 10 % blev der udledt en tilbageholdelsestid på 66 dage.
English: Ivermectin is currently included in Annex I of Council Regulation (EEC) No 2377/90 with MRLs for all food producing species as follows:
Danish: Ivermectin er i øjeblikket indeholdt i bilag I til Rådets forordning (EØF) nr. 2377/90 med følgende maksimalgrænseværdier for restkoncentrationer for alle arter bestemt til levnedsmiddelproduktion:
English: 13721 PAROLA Finland
Danish: 13721 PAROLA
English: Marketing Authorisations for injectable veterinary medicinal products containing ivermectin for use in cattle have been granted in all Member States of the European Union via different authorisation procedures (mutual recognition procedures and national procedures) and under various legal bases (full, generic, bibliographic, informed consent).
Danish: Markedsføringstilladelser til injicerbare veterinærlægemidler indeholdende ivermectin til kvæg er blevet udstedt i alle EU's medlemsstater via forskellige godkendelsesprocedurer (procedurer for gensidig anerkendelse og nationale procedurer) og på forskellige retlige grundlag (fuldt, generisk, bibliografisk, informeret samtykke).