FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Danish: - Ved akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina pectoris eller myokardieinfarkt uden forekomst af Q-takker) bør behandling med clopidogrel indledes med en enkelt initial mætningsdosis på 300 mg og derefter fortsættes med 75 mg én gang dagligt (sammen med acetylsalicylsyre (ASA) 75 mg - 325 mg dagligt).
English: Serum sickness, anaphylactoid reactions cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*
Danish: 4.4)*, insulin autoimmun syndrom, som kan føre til alvorlig hypoglykæmi, især hos patienter med HLA DRA4 subtype (hyppigere i den japanske befolkning)*
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Danish: Antallet af patienter, som oplevede det primære endepunkt [kardiovaskulært dødsfald, myokardieinfarkt eller apopleksi] var 582 (9,3 %) i clopidogrelgruppen og 719 (11,4 %) i placebogruppen, hvilket giver en relativ risikoreduktion på 20 % (95 % CI: 10 %-28 %; p=0,00009) for clopidogrelgruppen (en relativ risikoreduktion på 17 %, når patienterne fik konservativ behandling, 29 %, når de fik perkutan transluminal koronar angioplastik (PTCA) med eller uden stent, og 10 %, når de fik koronar bypassoperation (CABG)).
English: What Clopidogrel BGR looks like and contents of the pack The film-coated tablets are pink, round and slightly convex.
Danish: Udseende og pakningsstørrelser De filmovertrukne tabletter er lyserøde, runde og let hvælvede.
English: What you need to know before you take Clopidogrel BGR
Danish: Det skal du vide, før du begynder at tage Clopidogrel BGR
English: Laboratoires BIOGARAN 15, boulevard Charles de Gaulle - 92707 Colombes Cedex, France
Danish: Laboratoires BIOGARAN 15, boulevard Charles de Gaulle - 92707 Colombes Cedex, Frankrig
English: Laboratoires BIOGARAN 15, boulevard Charles de Gaulle 92707 Colombes Cedex France
Danish: Laboratoires BIOGARAN 15, boulevard Charles de Gaulle 92707 Colombes Cedex Frankrig
English: Clopidogrel BGR 75 mg film-coated tablets clopidogrel
Danish: Clopidogrel BGR 75 mg filmovertrukne tabletter clopidogrel
English: Clopidogrel BGR 75 mg film-coated tablets
Danish: Clopidogrel BGR 75 mg filmovertrukne tabletter
English: • if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Danish: • hvis du har risiko for blødninger f.eks. på grund af: - en medicinsk lidelse, der medfører risiko for indre blødninger (såsom et mavesår) - en blødningslidelse, der giver dig tendens til indre blødning (blødning inde i et af kroppens væv, organer eller led) - en nylig alvorlig kvæstelse - en nyligt kirurgisk indgreb (gælder også tandoperationer) - en planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Danish: traumer, kirurgi eller andre patologiske tilstande samt til patienter, der samtidigt behandles med ASA, heparin, glykoprotein IIb/IIIa-hæmmere, nonsteroide antiinflammatoriske lægemidler inklusive cox-2hæmmere eller selektive serotoningenoptagelseshæmmere (SSRI'er), eller andre lægemidler forbundet med risiko for blødning, såsom pentoxifyllin (se pkt.
English: Blister Store in the original package in order to protect from moisture and light.
Danish: Blister Opbevares i den originale pakning for at beskytte mod fugt og lys.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Brug af anden medicin sammen med Clopidogrel BGR Fortæl det altid till lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: For blister Store in the original package in order to protect from moisture and light.
Danish: For blister Opbevares i den originale yderpakning for at beskytte mod fugt og lys.
English: Therapeutic experience with clopidogrel is limited in patients with renal impairment.
Danish: Der er begrænset erfaring med behandling af patienter med nedsat nyresygdom.
English: Manufacturer
Danish: PRODUKTRESUME
English: ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Danish: • Voksne patienter med myokardieinfarkt (MI) (fra få dage, men ikke over 35 dage), iskæmisk apopleksi (fra 7 dage, men ikke over 6 måneder) eller påviste perifere kredsløbsforstyrrelser.
English: How to take Clopidogrel BGR
Danish: Sådan skal du tage Clopidogrel BGR
English: What you need to know before you take Clopidogrel BGR 3.
Danish: Det skal du vide, før du begynder at tage Clopidogrel BGR Sådan skal du tage Clopidogrel BGR Bivirkninger
English: What Clopidogrel BGR contains - The active substance is clopidogrel.
Danish: Clopidogrel BGR 75 mg filmovertrukne tabletter indeholder: - Aktivt stof: clopidogrel.
English: 23 May 2011
Danish: 23. maj 2011
English: The European Commission issued a decision on this opinion on 23 May 2011.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 23. maj 2011.
English: It is authorised in Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom.
Danish: Det er godkendt i Østrig, Belgien, Bulgarien, Cypern, Den Tjekkiske Republik, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige.
English: The suspension will remain in place until the problem has been rectified.
Danish: Suspenderingen vil vare ved, indtil problemet er blevet løst.
English: Octagam is made by Octopharma.
Danish: Octagam fremstilles af Octopharma.
English: • Doctors should stop using Octagam and switch their patients to the most appropriate alternative treatment.
Danish: • Læger bør ikke længere ordinere Octagam, og de bør lade deres patienter skifte til en passende alternativ behandling.
English: In September 2010, the German and Swedish medicines regulatory agencies suspended marketing authorisations for Octagam.
Danish: I september 2010 suspenderede de tyske og svenske lægemiddelkontrolmyndigheder markedsføringstilladelserne for Octagam.
English: The CHMP noted that, based on the available information, there was clear evidence of a recent increase in thromboembolic events associated with Octagam but that the exact cause of the problems could not be identified with certainty.
Danish: CHMP bemærkede, at der på baggrund af den tilgængelige information var et klart bevis for en nylig stigning i antallet af tromboemboliske hændelser i forbindelse med Octagam, men at den nøjagtige årsag til problemerne ikke kunne fastlægges med sikkerhed.
English: As required by Article 107, the German and Swedish agencies informed the CHMP of their actions so that the Committee could prepare an opinion on whether the marketing authorisations for Octagam should be maintained, changed, suspended or withdrawn across the EU.
Danish: Sådan som artikel 107 foreskriver, informerede de tyske og svenske lægemiddelkontrolmyndigheder CHMP om de foranstaltninger, de havde truffet, så udvalget kunne udarbejde en udtalelse om, hvorvidt markedsføringstilladelserne for Octagam burde opretholdes, ændres, suspenderes eller tilbagekaldes i hele EU.
English: Human normal immunoglobulins are antibodies (types of protein) normally found in the blood that help the body to fight infections and other diseases.
Danish: Humant normalt immunoglobulin er antistoffer (en type proteiner), der normalt findes i blodet, og som hjælper kroppen med at bekæmpe infektioner og andre sygdomme.
English: Questions and answers on the suspension of the marketing authorisations for Octagam (human normal immunoglobulin 5% and 10%)
Danish: Spørgsmål og svar vedrørende suspenderingen af markedsføringstilladelserne for Octagam (humant normalt immunoglobulin 5 % og 10 %)
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that all marketing authorisations for the medicine be suspended throughout the European Union (EU) and that Octagam currently on the market be recalled.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) anbefalede, at alle markedsføringstilladelser for lægemidlet suspenderes i hele Den Europæiske Union (EU), og at man tilbagekalder det Octagam, der i øjeblikket er på markedet.
English: Questions and answers on the suspension of the marketing authorisations for Octagam (human normal immunoglobulin 5% and 10%) EMA/588737/2010 rev.1
Danish: Spørgsmål og svar vedrørende suspenderingen af markedsføringstilladelserne for Octagam (humant normalt immunoglobulin 5 % og 10 %) EMA/588737/2010 rev.1
English: This follows an unexpectedly high number of reports of serious thromboembolic events (problems due to the formation of blood clots in the blood vessels) in patients taking the medicine.
Danish: Det skete efter et uventet højt antal indberetninger af alvorlige tromboemboliske hændelser (problemer, som skyldes dannelsen af blodpropper i blodkarrene) hos patienter, der tager lægemidlet.
English: The European Medicines Agency has completed a review of Octagam triggered by reports of serious thromboembolic events.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Octagam som følge af indberetninger af alvorlige tromboemboliske hændelser.
English: The CHMP reviewed the reported thromboembolic events and looked at evidence related to the medicine's safety.
Danish: CHMP vurderede de indberettede tromboemboliske hændelser og så på dokumentationen i forbindelse med lægemidlets sikkerhed.
English: The CHMP therefore recommended that, because of the safety concerns with Octagam, the marketing authorisations for the medicine be suspended in the EU.
Danish: På grund af sikkerhedsproblemerne med Octagam anbefalede CHMP således, at markedsføringstilladelserne for lægemidlet suspenderes i EU.
English: These events were thought to be related to problems with the medicine's manufacture, and included stroke, myocardial infarction (heart attack) and pulmonary embolism (clot in a blood vessel supplying the lungs).
Danish: problemer med lægemidlets fremstilling, og de omfattede slagtilfælde, myokardieinfarkt (hjerteanfald) og lungeemboli (en blodprop i et blodkar, der forsyner lungerne med blod).
English: While the marketing authorisations are suspended, Octagam will not be available.
Danish: Octagam vil ikke være i handelen, så længe markedsføringstilladelserne er suspenderet.
English: Its effect may improve further for up to six months.
Danish: Virkningen kan forbedres yderligere i op til seks måneder.
English: It is available as tablets (10, 15 and 20 mg).
Danish: Det fås som tabletter (10, 15 og 20 mg).
English: The medicine usually starts to have an effect after four to six weeks.
Danish: Lægemidlet begynder normalt at virke efter fire til seks uger.
English: EMA/CHMP/328573/2014 EMEA/H/C/001227
Danish: EMA/265372/2014 EMEA/H/C/001227
English: The full EPAR for Leflunomide medac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Leflunomide medac findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide medac on 27 July 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Leflunomide medac den 27. juli 2010.
English: This document is a summary of the European public assessment report (EPAR) for Leflunomide medac.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Leflunomide medac.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Leflunomide medac.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Leflunomide medac.
English: A risk management plan has been developed to ensure that Leflunomide medac is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Leflunomide medac anvendes så sikkert som muligt.
English: Leflunomide medac treatment usually starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Danish: Behandlingen med Leflunomide medac indledes sædvanligvis med en ”initialdosis” på 100 mg en gang dagligt i tre dage efterfulgt af en vedligeholdelsesdosis.
English: This means that Leflunomide medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Danish: Det betyder, at Leflunomide medac er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Arava.
English: The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Danish: Den anbefalede vedligeholdelsesdosis er 10 til 20 mg en gang dagligt til patienter med rheumatoid arthritis og 20 mg en gang dagligt til patienter med arthritis psoriatica.
English: Leflunomide medac leflunomide
Danish: Leflunomide medac leflunomid
English: Leflunomide medac EMA/CHMP/328573/2014
Danish: Leflunomide medac EMA/265372/2014
English: For more information about treatment with Leflunomide medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Leflunomide medac, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Danish: Med færre lymfocytter opstår der mindre betændelse, hvilket er med til at dæmpe symptomerne på arthritis.
English: Leflunomide medac is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Danish: Leflunomide medac anvendes til behandling af voksne med aktiv rheumatoid arthritis (en immunsygdom, der fremkalder inflammation (betændelse) i leddene) eller aktiv arthritis psoriatica (en sygdom, som fremkalder røde, afskallende pletter på huden og inflammation i leddene).
English: The CHMP concluded that, in accordance with EU requirements, Leflunomide medac has been shown to have comparable quality and to be bioequivalent to Arava.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Leflunomide medac er af sammenlignelig kvalitet og er bioækvivalent med Arava.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide medac, and regularly during treatment.
Danish: Lægen skal tage blodprøver for at kontrollere patientens lever, leukocyttal og trombocyttal, inden der ordineres Leflunomide medac, og regelmæssigt under behandlingen.
English: Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Danish: Leflunomid gør dette ved at blokere for et enzym kaldet ”dihydroorotat dehydrogenase”, som er nødvendigt for, at lymfocytter kan dele sig.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Leflunomide medac, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Leflunomide medac, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Other information about Leflunomide medac:
Danish: Andre oplysninger om Leflunomide medac:
English: It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Danish: Det reducerer inflammationen ved at begrænse dannelsen af immunceller kaldet ”lymfocytter”, som forårsager inflammationen.
English: Therefore, the CHMP's view was that, as for Arava, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Arava.
English: Leflunomide medac treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Danish: Behandling med Leflunomide medac må kun iværksættes og overvåges af en specialist med erfaring i behandling af patienter med rheumatoid arthritis og arthritis psoriatica.
English: What measures are being taken to ensure the safe and effective use of Leflunomide medac ?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Leflunomide medac?
English: Leflunomide medac is a ‘generic medicine'.
Danish: Leflunomide medac er et ‘generisk lægemiddel'.
English: Because Leflunomide medac is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Danish: Da Leflunomide medac er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The Committee recommended that Leflunomide medac be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Leflunomide medac.
English: Leflunomide medac is a medicine that contains the active substance leflunomide.
Danish: Leflunomide medac er et lægemiddel, der indeholder det aktive stof leflunomid.
English: The active substance in Leflunomide medac, leflunomide, is an immunosuppressant.
Danish: Det aktive stof i Leflunomide medac, leflunomid, er et immundæmpende stof.
English: Because Leflunomide medac is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Danish: Da Leflunomide medac er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Arava.
English: What are the benefit and risk of Leflunomide medac?
Danish: Hvilken fordel og risiko er der forbundet med Leflunomide medac?
English: Why has Leflunomide medac been approved?
Danish: Hvorfor blev Leflunomide medac godkendt?
English: What is Leflunomide medac?
Danish: Hvad er Leflunomide medac?
English: How has Leflunomide medac been studied?
Danish: Hvordan blev Leflunomide medac undersøgt?
English: What is Leflunomide medac used for?
Danish: Hvad anvendes Leflunomide medac til?
English: How is Leflunomide medac used?
Danish: Hvordan anvendes Leflunomide medac?
English: How does Leflunomide medac work?
Danish: Hvordan virker Leflunomide medac?
English: MA (EU) number
Danish: EMA (EU) nummer
English: (Invented) name Strength Pharmaceutical form
Danish: (Særnavn) navn Styrke Lægemiddelform Administration
English: 3 x 28 tablets
Danish: 3 x 28 tabletter
English: It is available in packs of:
Danish: Det findes i pakninger med:
English: * Definition of frequency terms: Very common - ≥ 10 %; Common - > 5 % and < 10 %.
Danish: * Definition af hyppighed: Meget almindelig - ≥ 10%; Almindelig - > 5% og < 10%.
English: Reconstituted and infusion solution: The product should be used immediately.
Danish: Rekonstituerede opløsninger og infusionsopløsninger: Produktet skal anvendes med det samme.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler
English: Your doctor will discuss with you the potential risk of taking Pemetrexed Lilly during pregnancy.
Danish: Deres læge vil sammen med Dem drøfte den potentielle risiko ved at tage Pemetrexed Lilly under graviditet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 September 2015
Danish: Dato for første markedsføringstilladelse: 14. september 2015
English: Based on the planned date of your infusion of Pemetrexed Lilly and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Danish: Ud fra den planlagte dato for Deres infusion af Pemetrexed Lilly og/eller status for Deres nyrefunktion skal Deres læge fortælle Dem, hvilke typer medicin De må tage, og hvornår De må tage dem.
English: Interactions common to all cytotoxics
Danish: Interaktioner, der er fælles for alle cytotoksiske stoffer
English: Pemetrexed has a steady-state volume of distribution of 9 L/m2.
Danish: Pemetrexed har et steady state-fordelingsvolumen på 9 l/m2.
English: Safety was assessed for patients who were randomised to receive pemetrexed (N = 800).
Danish: Sikkerheden blev vurderet for de patienter, som blev randomiseret til pemetrexed (N=800).
English: In vitro studies indicate that pemetrexed is actively secreted by OAT3 (organic anion transporter.
Danish: In vitro-studier indikerer, at pemetrexed udskilles ved aktiv sekretion via OAT3 (organisk anion-transporter).
English: It is unknown whether pemetrexed is excreted in human milk and adverse reactions on the suckling child cannot be excluded.
Danish: Det er ukendt, om pemetrexed udskilles i human mælk, og en påvirkning af ammede børn kan ikke udelukkes.
English: Reconstituted and infusion solution
Danish: Rekonstituerede opløsninger og infusionsopløsninger