FrancophonIA/ELRC3.0 huggingface dataset:
English: The final opinion was converted into a Decision by the European Commission on 11 December 2014.
Danish: Den endelige udtalelse blev den 11. december 2014 omarbejdet til en beslutning af EuropaKommissionen.
English: Written explanations were provided by the applicants and marketing authorisation holders on 10 December 2012, 14 October 2013, 1 April 2014 and 10 June 2014.
Danish: Ansøgerne og indehaverne af markedsføringstilladelse fremsendte skriftlige redegørelser den 10. december 2012, den 14. oktober 2013, den 1. april 2014 og den 10. juni 2014.
English: The Committee appointed C. Ibrahim as rapporteur and B. Urbain as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis C. Ibrahim og B. Urbain.
English: The referral started on 13 September 2012.
Danish: Indbringelsen blev indledt den 13. september 2012.
English: Oral explanations were given on 9 September 2014.
Danish: Mundtlige redegørelser blev afgivet den 9. september 2014.
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Danish: På grundlag af vurdering af de foreliggende data fandt CVMP, at det overordnede benefit/risk-forhold fortsat er positivt for disse produkter, forudsat at der ændres i produktinformationen.
English: The CVMP was requested to give its opinion on the indications, dosing regimens and withdrawal periods in cattle and pigs, in order to ensure efficacious treatment and lower the risk of development of antimicrobial resistance to spiramycin taking into account the available data and also to harmonise the withdrawal periods in cattle and pigs for the concerned products.
Danish: CVMP blev anmodet om at fremsætte en udtalelse om indikationer, doseringsregimer og tilbageholdelsestider hos kvæg og svin for at sikre effektiv behandling og mindske risikoen for opståen af antimikrobiel resistens over for spiramycin under hensyntagen til de foreliggende data og for at harmonisere tilbageholdelsestiderne hos kvæg og svin for de omhandlede produkter.
English: The veterinary medicinal products Suanovil 20 solution for injection and its generic product Spirovet are solutions for injection which contain 20 g spiramycin per 100 ml, corresponding to 600 000 IU spiramycin per ml.
Danish: Veterinærlægemidlerne Suanovil 20, injektionsvæske, opløsning, og det tilsvarende generiske produkt, Spirovet, er injektionsvæsker, opløsning, der indeholder 20 g spiramycin/100 ml, svarende til 600 000 IE spiramycin/ml.
English: Opinion following an Article 350F referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof EMA/745255/2014
Danish: Udtalelse efter en artikel 350F-indbringelse for Suanovil 20 og relaterede navne, Captalin og relaterede navne samt tilsvarende generiske produkter EMA/745255/2014
English: On 12 September 2012, Gemany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Suanovil 20 and associated names, Captalin and associated names and generic products thereof.
Danish: Den 12. september 2012 foretog Tyskland i medfør af artikel 35 i direktiv 2011/82/EF en indbringelse for agenturet for Suanovil 20 og relaterede navne, Captalin og relaterede navne samt tilsvarende generiske produkter.
English: Opinion following an Article 351 referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof
Danish: 1-indbringelse for Suanovil 20 og relaterede navne, Captalin og relaterede navne samt tilsvarende generiske produkter
English: 1 Article 35 of Directive 2001/82/EC, as amended 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 1 Artikel 35 i direktiv 2001/82/EF, som ændret.
English: Therefore, on 9 September 2014 the Committee adopted by majority a positive opinion, recommending variations to the terms of the marketing authorisations for Suanovil 20 and associated names, Captalin and associated names and generic products thereof.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom september 2014 vedtog udvalget ved en flertalsafgørelse derfor en positiv udtalelse og anbefalede ændring af betingelserne for markedsføringstilladelserne for Suanovil 20 og relaterede navne, Captalin og relaterede navne samt tilsvarende generiske produkter.
English: 10 vials Zero days
Danish: 10 hætteglas Zero dage
English: --1 Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ≥ 5.3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID50*/ml Clostridium tetani toxoid: ≥ 30 IU**/ml * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
Danish: --1 Influenza A/ eq/Ohio/03 [H3N8] rekombinant canarypox virus (vCP2242)  5,3 log10 FAID50*/ml Influenza A/eq [H3N8] rekombinant canarypox virus (vCP3011)  5,3 log10 FAID50 */ml Clostridium tetani toxoid: > 30 IU**/ml * vCP indhold kontrolleret ved global FAID50(fluorescent assay" infektiøs dosis 50 %) og qPCR rate mellem vCP.
English: Horses Intramuscular use vial (glass) 1 ml
Danish: 1 ml
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was due to a change in the company's strategy.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes en ændring i virksomhedens strategi.
English: On 5 December 2018, Pfizer Europe MA EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fyzoclad, for the treatment of a number of inflammatory diseases.
Danish: Den 5. december 2018 meddelte Pfizer Europe MA EEIG officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Fyzoclad til behandling af en række betændelsessygdomme.
English: This means that Fyzoclad was intended to be highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Fyzoclad i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: What was Fyzoclad expected to be used for?
Danish: Hvad forventedes Fyzoclad anvendt til?
English: As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Danish: Da CHMP var i færd med at vurdere den dokumentation, som virksomheden oprindelig havde fremlagt, havde det endnu ikke afgivet en udtalelse.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Danish: Ved at binde til TNF blokerer adalimumab TNF's aktivitet og reducerer dermed betændelse og andre symptomer på sygdommene.
English: This substance is involved in causing inflammation associated with the diseases that adalimumab is intended to treat and is found at high levels in patients with these diseases.
Danish: Dette stof medvirker til at forårsage den betændelse, der er forbundet med de sygdomme, som adalimumab er beregnet til at behandle, og det findes i høje koncentrationer hos patienter med disse sygdomme.
English: The company informed the CHMP that there are no ongoing clinical trials with Fyzoclad.
Danish: Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres kliniske studier af Fyzoclad.
English: The application was withdrawn while the CHMP was still evaluating the initial documentation provided by the company.
Danish: Ansøgningen blev trukket tilbage, mens CHMP stadig var i gang med at vurdere den dokumentation, som virksomheden oprindeligt havde fremlagt.
English: Fyzoclad is a medicine that contains the active substance adalimumab.
Danish: Fyzoclad er et lægemiddel, der indeholder det aktive stof adalimumab.
English: The company presented laboratory studies comparing Fyzoclad to its reference medicine Humira in terms of structure, purity and biological activity.
Danish: Virksomheden fremlagde laboratoriestudier, der sammenlignede Fyzoclad og referencelægemidlet Humira med hensyn til struktur, renhed og biologisk aktivitet.
English: Fyzoclad was developed as a ‘biosimilar' medicine.
Danish: Fyzoclad blev udviklet som et "biosimilært" lægemiddel.
English: Fyzoclad acts on the immune system and was to be used to treat the following inflammatory conditions:
Danish: Fyzoclad virker på immunsystemet og forventedes at blive anvendt til at behandle følgende betændelsestilstande:
English: The reference medicine for Fyzoclad is Humira.
Danish: Referencelægemidlet for Fyzoclad er Humira.
English: What is Fyzoclad?
Danish: Hvad er Fyzoclad?
English: Fyzoclad was expected to work in the same way as the reference medicine, Humira.
Danish: Fyzoclad forventedes at virke på samme måde som referencelægemidlet Humira.
English: It was to be available as a solution for injection.
Danish: Det var meningen, at det skulle kunne fås som injektionsvæske.
English: • uveitis (inflammation of the layer beneath the white of the eyeball) and paediatric uveitis.
Danish: • uveitis (betændelse i hinden under det hvide i øjenæblet) og pædiatrisk uveitis.
English: How does Fyzoclad work?
Danish: Hvordan virker Fyzoclad?
English: • psoriasis and paediatric plaque psoriasis (both are diseases causing red, scaly patches on the skin).
Danish: • psoriasis og pædiatrisk plaquepsoriasis (begge er sygdomme, som fremkalder røde, skællende hudområder)
English: 13 December 2018
Danish: 13. december 2018 EMA/10643/2019
English: The active substance in Fyzoclad and Humira, adalimumab, is a monoclonal antibody (a type of protein) that has
Danish: Det aktive stof i Fyzoclad og Humira, adalimumab, er et monoklonalt antistof (en type protein), der er designet til at genkende og binde til et stof i kroppen, der kaldes tumornekrosefaktor (TNF).
English: • juvenile idiopathic arthritis (disease causing inflammation in the joints);
Danish: • børnegigt (juvenil idiopatisk artritis; en sygdom, der forårsager betændelse i leddene)
English: In addition, a study in patients with rheumatoid arthritis compared Fyzoclad with Humira.
Danish: Desuden blev Fyzoclad sammenlignet med Humira i et studie af patienter med leddegigt.
English: • axial spondyloarthritis (inflammation of the spine causing back pain);
Danish: • aksial spondyloartritis (betændelse i rygsøjlen, der medfører rygsmerter)
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Danish: • psoriasisgigt (en sygdom, der giver røde, skællende hudområder og betændelse i leddene)
English: • rheumatoid arthritis (a disease causing inflammation of the joints);
Danish: • leddegigt (reumatoid artritis; en sygdom, der forårsager betændelse i leddene)
English: Children Procoralan is not intended for use in children and adolescents younger than 18 years.
Danish: Børn Procoralan er ikke beregnet til børn og unge under 18 år.
English: If you forget to take a dose of Procoralan, take the next dose at the usual time.
Danish: Hvis De glemmer at tage en dosis Procoralan, skal De tage den næste dosis til normal tid.
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Procoralan.
Danish: Kalenderen på blisteren, som indeholder tabletterne, skal hjælpe Dem med at huske, hvornår De sidst tog en Procoralan tablet.
English: If any of the above applies to you, talk straight away to your doctor before or while taking Procoralan.
Danish: Hvis noget af ovenstående gælder for Dem, skal De straks tale med Deres læge om det, før eller mens De tager Procoralan.
English: 92284 Suresnes cedex - France
Danish: 92284 Suresnes cedex - Frankrig
English: A large dose of Procoralan could make you feel breathless or tired because your heart slows down too much.
Danish: En stor dosis Procoralan kan få Dem til at føle Dem kortåndet eller træt, fordi Deres hjerte slår for langsomt.
English: Procoralan with food and drink Avoid grapefruit juice during treatment with Procoralan.
Danish: Brug af Procoralan sammen med mad og drikke Undgå grapefrugtjuice under behandling med Procoralan.
English: Procoralan should be taken during meals.
Danish: Procoralan skal helst tages under et måltid.
English: Procoralan contains lactose
Danish: Procoralan indeholder lactose
English: Procoralan mainly works by reducing the heart rate by a few beats per minute.
Danish: Procoralan virker hovedsageligt ved at nedsætte hjertefrekvensen med nogle få slag pr. minut.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Procoralan in all subsets of the paediatric population in the treatment of angina pectoris.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Procoralan i alle undergrupper af den pædiatriske population med angina pectoris.
English: In this way Procoralan helps to control and reduce the number of angina attacks.
Danish: På den måde hjælper Procoralan med at kontrollere og nedsætte antallet af anfald af hjertekrampe.
English: - in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30
Danish: - Hos patienter med dysfunktion af venstre ventrikel (venstre ventrikulære uddrivningsfraktion (LVEF)
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common: may affect up to 1 in 10 people uncommon: may affect up to 1 in 100 people rare: may affect up to 1 in 1,000 people very rare: may affect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
Danish: Meget almindelig: kan påvirke flere end 1 ud af 10 mennesker Almindelig: kan påvirke op til 1 ud af 10 mennsker Ikke almindelig: kan påvirke op til 1 ud af 100 mennesker Sjælden: kan påvirke op til 1 ud af 1.000 mennesker Meget sjælden: kan påvirke op til 1 ud af 10.000 mennesker Ikke kendt: kan ikke bedømmes ud fra forhåndenværende data
English: Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Procoralan.
Danish: Tal med lægen, hvis De ammer eller ønsker at amme, da amning skal ophøre, hvis De tager Procoralan.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om Procoralan findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Date of latest renewal: 25/10/2010
Danish: Dato for første markedsføringstilladelse: 25. oktober 2005 Dato for seneste fornyelse: 25.oktober 2010
English: Procoralan may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Danish: Procoralan kan forårsage forbigående lysfænomener (forbigående lysglimt i synsfeltet, se under ”Bivirkninger”).
English: Do not take Procoralan if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Procoralan”).
Danish: Tag ikke Procoralan, hvis De kan blive gravid, medmindre De anvender sikker prævention (se ”Tag ikke Procoralan”).
English: The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to, <1/10); uncommon (≥1/1,000 to, <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: I de kliniske studier er der rapporteret om følgende bivirkninger, som er opstillet efter hyppighed i henhold til denne konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Procoralan 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Danish: I nogle tilfælde (fx hvis De er ældre) kan Deres læge halvere dosis, dvs. en halv Procoralan-tablet på 5 mg (svarende til 2,5 mg ivabradin) om morgenen og en halv tablet på 5 mg om aftenen.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Procoralan in one or more subsets of the paediatric population in the treatment of chronic heart failure (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Procoralan i en eller flere undergrupper af den pædiatriske population med kronisk hjerteinsufficiens (se pkt.
English: Other medicines and Procoralan
Danish: Brug af anden medicin sammen med Procoralan
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/316/001-007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/316/001-007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/316/008-014
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/316/008-014
English: What you need to know before you take Procoralan
Danish: Det skal De vide, før De begynder at tage Procoralan
English: INFORMATION IN BRAILLE PROCORALAN 5 mg
Danish: INFORMATION I BRAILLESKRIFT PROCORALAN 5 mg
English: The starting dose should not exceed one tablet of Procoralan 5 mg twice daily.
Danish: Startdosis bør ikke være mere end en Procoralan-tablet på 5 mg to gange dagligt.
English: Procoralan (ivabradine) is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Danish: Procoralan (ivabradin) er hjertemedicin, som anvendes til behandling af: - Symptomerne ved stabil angina pectoris (en lidelse, som forårsager smerter i brystet) hos voksne patienter med en puls på mindst 70 slag i minuttet.
English: The usual recommended starting dose is one tablet of Procoralan 5 mg twice daily increasing if necessary to one tablet of Procoralan 7.5 mg twice daily.
Danish: Den sædvanlige startdosis er en Procoralantablet på 5 mg to gange daglig, og den kan om nødvendigt øges til en Procoralantablet på 7,5 mg to gange daglig.
English: INFORMATION IN BRAILLE PROCORALAN 7.5 mg
Danish: INFORMATION I BRAILLESKRIFT PROCORALAN 7,5 mg
English: Do not take Procoralan if you are pregnant or are planning to have a baby (see “Do not take Procoralan”).
Danish: De må ikke tage Procoralan, hvis De er gravid eller planlægger at blive gravid (se under ”Tag ikke Procoralan”).
English: If you stop taking Procoralan:
Danish: Hvis De holder op med at tage Procoralan
English: Procoralan 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other.
Danish: Procoralan 7,5 mg tabletter er laksefarvede, trekantede filmovertrukne tabletter, mærket med ”7.5” på den ene side og på den anden.
English: If you forget to take Procoralan:
Danish: Hvis De har glemt at tage Procoralan
English: Do not take Procoralan if you are breast-feeding (see “Do not take Procoralan”).
Danish: De må ikke tage Procoralan, hvis De ammer (se under ”Tag ikke Procoralan”).
English: What Procoralan contains - The active substance is ivabradine (as hydrochloride).
Danish: Aktivt stof: ivabradin (som hydrochlorid)
English: It is used in combination with standard therapy, including beta-blocker therapy or when betablockers are contraindicated or not tolerated.
Danish: Procoralan bruges sammen med standardbehandling med betablokker, eller når patienten ikke må få eller ikke kan tåle betablokker.
English: Talk to your doctor or pharmacist before taking Procoralan - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
Danish: Kontakt lægen eller apoteketspersonalet, før De tager Procoralan hvis De lider af forstyrrelser i hjertets rytme (uregelmæssig puls, hjertebanken, smerter i brystkassen) eller vedvarende hjerteflimmer (hurtig, meget uregelmæssig puls) eller en abnormitet i elektrokardiogrammet (ekg) kaldet ”lang QT-syndrom” hvis De har symptomer som træthed, svimmelhed eller kortåndethed (det kan betyde, at Deres hjerte slår for langsomt) hvis De lider af symptomer på artrieflimren (hvilepulsen er usædvanlig høj (over 110 slag i minuttet) eller uregelmæssig uden nogen tydelig grund, hvilket gør det vanskeligt at måle pulsen) hvis De for nylig har haft et slagtilfælde (blodprop i hjernen/hjerneblødning) hvis De lider af lavt blodtryk i let til moderat grad hvis Deres blodtryk ikke er under kontrol - især efter en ændring i Deres blodtryksbehandling hvis De lider af alvorligt hjertesvigt eller hjertesvigt med en abnormitet i ekg kaldet ”grenblok” hvis De lider af en kronisk nethindesygdom i øjet hvis De lider af moderate leverproblemer hvis De lider af svære problemer med nyrerne
English: If you are pregnant and have taken Procoralan, talk to your doctor.
Danish: Tal med Deres læge, hvis De er gravid og har taget Procoralan.
English: Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Danish: Behandling af kronisk hjerteinsufficiens Ivabradin er indiceret ved kronisk hjerteinsufficiens af NYHA-klasse II til IV med systolisk dysfunktion hos patienter med normal sinusrytme og hjertefrekvens på ≥ 75 slag i minuttet i kombination med standardbehandling inkluderende betablokker, eller når betablokker er kontraindiceret eller ikke tolereres (se pkt.
English: How to take Procoralan
Danish: Sådan skal De tage Procoralan
English: If you think that the effect of Procoralan is too strong or too weak, talk to your doctor or pharmacist.
Danish: Tal med Deres læge eller apoteket, hvis De mener, at virkningerne af Procoralan er for kraftige eller for svage.
English: Procoralan 5 mg film-coated tablets Procoralan 7.5 mg film-coated tablets ivabradine
Danish: Procoralan 5 mg filmovertrukne tabletter Procoralan 7,5 mg filmovertrukne tabletter ivabradin
English: What Procoralan looks like and contents of the pack Procoralan 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and on the other.
Danish: Procoralan 5 mg tabletter er laksefarvede, aflange filmovertrukne tabletter med delekærv på begge sider, mærket med ”5” på den ene side og på den anden.
English: Servier Italia S.p.A. Tel: +39 (06) 669081
Danish: Tel: +39 (06) 669081
English: How does Procoralan work?
Danish: Sådan virker Procoralan