FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not stop the treatment unless your doctor tells you so.
Danish: Hvis du holder op med at tage Clopidogrel Apotex Du må ikke ophøre med behandlingen, medmindre din læge fortæller dig, at du skal gøre det.
English: 2333 CN , Leiden The Netherlands
Danish: 2333 CN, Leiden
English: What you need to know before you take Clopidogrel Apotex
Danish: Det skal du vide, før du begynder at tage Clopidogrel Apotex
English: The number of patients who reached the primary endpoint (time to first occurrence of stroke, MI, non-CNS systemic embolism or vascular death) was 832 (22.1%) in the group treated with clopidogrel + ASA and 924 (24.4%) in the placebo + ASA group (relative risk reduction of 11.1%; 95% CI of 2.4% to 19.1%; p=0.013), primarily due to a large reduction in the incidence of strokes.
Danish: Antallet af patienter, der nåede det primære endepunkt (tid til første forekomst af apopleksi, MI, nonCNS systemisk emboli eller vaskulær død) var 832 (22,1%) i gruppen behandlet med clopidogrel + ASA og 924 (24,4%) i placebo + ASA-gruppen (relativ risikoreduktion 11,1%; 95% CI 2,4% til19,1%, p = 0,013).
English: While you are taking Clopidogrel Apotex:
Danish: Mens du er i behandling med Clopidogrel Apotex:
English: However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents
Danish: Imidlertid fik de patienter, som indgik i kliniske studier med clopidogrel, en lang række ledsagende lægemidler såsom diuretika, beta-blokkere, ACE-hæmmere, calciumantagonister, kolesterolsænkende midler, dilatatorer med effekt på koronarkarrene, antidiabetika (inklusive insulin), antiepileptika samt GPIIb/IIIa-hæmmere, uden at der blev påvist klinisksignifikante uønskede interaktioner.
English: Clopidogrel Apotex 75 mg
Danish: INFORMATION I BRAILLESKRIFT Clopidogrel Apotex 75 mg
English: Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema,
Danish: Johnsons syndrom, erythema multiforme), akut generaliseret exanthematøs pustulose (AGEP)),angioødem lægemiddelinduceret overfølsomhedssyndrom, medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS), erytematøst eller eksfoliativt udslæt, urticaria, eksem, lichen planus
English: Clopidogrel was not shown to alter fertility in animal studies.
Danish: I dyreforsøg blev det ikke vist, at Clopidogrel ændrer fertiliteten.
English: abnormal liver function test
Danish: unormal leverfunktionstest
English: Strokes occurred in 296 (7.8%) patients receiving clopidogrel + ASA and 408 (10.8%) patients receiving placebo + ASA (relative risk reduction, 28.4%; 95% CI, 16.8% to 38.3%; p=0.00001).
Danish: der fik placebo + ASA (relativ risikoreduktion 28,4%; 95% CI, 16,8% til 38,3%, p =0,00001).
English: Other medicines and Clopidogrel Apotex
Danish: Brug af anden medicin sammen med Clopidogrel Apotex:
English: 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 autoimmunt syndrom, der kan lede til svær hypoglykæmi, især hos patienter med HLA DRA4
English: How to take Clopidogrel Apotex
Danish: Sådan skal du tage Clopidogrel Apotex
English: 4.2 Posology and method of administration Posology
Danish: 4.2 Dosering og indgivelsesmåde Dosering
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS containing 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets 1.
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS (Blisterkort med 7, 14, 28, 30, 50, 56, 84, 90 eller 100 filmovertrukne tabletter) 1.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Apotex Europe B.V.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Apotex Europe BV
English: not known*
Danish: Ikke relevant
English: Gyanecomastia
Danish: Atrieflimren
English: PC: SN: NN:
Danish: SN: {nummer}
English: Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
Danish: I overensstemmelse med resultaterne ovenfor blev det vist i en metaanalyse af 6 studier med335 clopidogrelbehandlede ved steady state, at eksponeringen for den aktive metabolit blev nedsat med 28 %
English: Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken.
Danish: Før planlagt kirurgi og før ordination af nye lægemidler bør patienterne informere deres læge og tandlæge om, at de tager clopidogrel.
English: Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
Danish: Overfølsomhedsreaktioner med bryst- eller mavesmerter, vedvarende symptomer på lavt blodsukker.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON for blisters of 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets
Danish: Karton til blisterpakninger med 7, 14, 28, 30, 50, 56, 84, 90 eller 100 filmovertrukne tabletter
English: Rash, pruritus, skin bleeding (purpura)
Danish: hudblødning (purpura)
English: Musculoskeletal, connective tissue and bone disorders
Danish: muskler og bindevæv
English: Vascular disorders Haematoma
Danish: Bulløs dermatitis
English: Ninety five patients (7%) in the guided de-escalation group and 118 patients (9%) in the control group (p non-inferiority=0.0004) had an event.
Danish: Det primære endepunkt (den kombinerede incidens af kardiovaskulær død, MI, slagtilfælde og BARCblødning grad ≥2 ved 12 måneder) blev opfyldt visende non-inferioritet.Femoghalvfems patienter (7 %) i den guidede de-ekaleringsgruppe og 118 patienter (9 %) i kontrolgruppen (p non-inferioritet=0,0004) havde en hændelse.
English: Hepatic impairment
Danish: hepatitis,
English: Some other medicines may influence the use of Clopidogrel Apotex or vice versa.
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler Visse andre typer medicin kan påvirke brugen af Clopidogrel Apotex eller omvendt.
English: Acute liver failure, hepatitis,
Danish: Akut leversvigt,
English: Contact your doctor immediately if you experience: - fever, signs of infection or extreme tiredness.
Danish: Feber, tegn på infektion eller alvorlig kraftesløshed (asteni).
English: What you need to know before you take Clopidogrel Apotex 3.
Danish: Det skal du vide, før du begynder at tage Clopidogrel Apotex Sådan skal du tage Clopidogrel Apotex Bivirkninger
English: Very rare,
Danish: kløe,
English: In PVC/PE/PVDC/aluminium blisters, store below 25°C.
Danish: Blisterkort af PVC/PE/PVDC/aluminium skal opbevares ved temperaturer under 25ºC Blisterkort kun i aluminium kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: For the full list of excipients, see section 6.1.
Danish: 2 eller pkt.6.1.
English: Pack size bottle (HDPE)
Danish: Flaske (HDPE) Blister (alu/alu)
English: Route of Administration
Danish: Oral anvendelse Oral anvendelse
English: Immediate Packaging Pack size
Danish: EU/1/16/1136/002 CABOMETYX 20 mg Filmovertrukkentablet bottle (HDPE)
English: London, 16 September 2008 EMEA/CHMP/500252/2008
Danish: London, den 16. september 2008 EMEA/CHMP/500086/2008
English: The Marketing Authorisation Holder provided supplementary information on 19 March 2008
Danish: Indehaveren af markedsføringstilladelsen fremsendte supplerende oplysninger den 19. marts 2008.
English: The procedure started on 15 November 2007.
Danish: Proceduren blev indledt den 15. november 2007.
English: A Decision was issued by the European Commission on 15 September 2008.
Danish: Europa-Kommissionen traf en afgørelse den 15. september 2008.
English: Remeron and associated names, 15, 30 and 45 mg tablets, 15, 30 and 45 mg orodispersible tablets, 15 mg/ml oral solution, is a noradrenergic and specific serotonergic antidepressant indicated for the treatment of episodes of major depression.
Danish: Remeron og tilknyttede navne, 15, 30 og 45 mg tabletter, 15, 30 og 45 mg smeltetabletter, 15 mg/ml oral opløsning, er et noradrenergt og specifikt serotonergt antidepressivum, der er indiceret til behandling af tilfælde af svær depression.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Remeron and associated names International Non-Proprietary Name (INN): mirtazapine
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 30 OM Remeron og tilknyttede navne Internationalt fællesnavn (INN): mirtazapin
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Remeron and associated names approved across EU Member States, with respect to treatment of major depressive episodes.
Danish: Grundlaget for indbringelsen var, at der var afvigelser i produktresuméerne (SPC), herunder kvalitetsaspekter, for Remeron og tilknyttede navne, som er godkendt i alle EU-medlemsstaterne, med henblik på behandling af tilfælde af svær depression.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og det ændrede produktresumé, etikettering og indlægsseddel i bilag III.
English: During its June 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet including the quality aspects was acceptable and that they should be amended.
Danish: På mødet i juni 2008 var CHMP, på baggrund af de samlede fremlagte oplysninger og den faglige drøftelse i udvalget, af den opfattelse, at forslaget til harmonisering af produktresumé, etikettering og indlægsseddel, herunder kvalitetsaspekterne, var acceptabelt, og at de følgelig burde ændres.
English: The CHMP gave a positive opinion on 26 June 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Remeron and associated names.
Danish: CHMP afgav en positiv udtalelse den 26. juni 2008, hvori udvalget anbefalede harmonisering af produktresumé, etikettering og indlægsseddel, herunder kvalitetsaspekter, for Remeron og tilknyttede navne.
English: On 11 October 2007, N.V. Organon presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet, including quality aspects of the medicinal product Remeron and associated names.
Danish: Organon en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, for at harmonisere de nationalt godkendte produktresuméer (SPC), indlægsseddel og etikettering, herunder kvalitetsaspekter, for lægemidlet Remeron og tilknyttede navne.
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Danish: Det betyder, at der findes litteraturoplysninger, der danner videnskabelig dokumentation for deres virkning og sikkerhed ved denne anvendelse i en periode på mindst 10 år i EU.
English: It should be taken during the day at least half an hour to one hour before or after taking other medicines and not immediately before bed-time.
Danish: Det skal tages om dagen mindst ½-1 time før eller efter indtagelse af eventuel anden medicin og ikke lige før sengetid.
English: EMA/HMPC/313692/2013
Danish: EMA/HMPC/313692/2013 Udvalget for Plantelægemidler (HMPC)
English: When handling the powder preparation, inhalation of the powder should be avoided as this may lead to allergic sensitization and the potential development of allergies.
Danish: Ved håndtering af pulverpræparater, bør inhalation af pulveret derfor undgås, da dette kan medføre allergisk overfølsomhed og eventuel udvikling af allergi.
English: If constipation does not resolve after three days a doctor or pharmacist should be consulted.
Danish: Hvis forstoppelsen ikke aftager efter tre dage, bør der søges råd hos en læge eller på apoteket.
English: Ispaghula seed is the common name for the seeds of the plant Plantago ovata Forssk.
Danish: Ispaghula-frø er fællesnavnet for frø fra planten Plantago ovata Forssk.
English: There is a risk of a build-up of hard, dry stool, particularly if ispaghula seed is swallowed without enough liquid.
Danish: Der er risiko for dannelse af hård, tør afføring, navnlig hvis ispaghula-frø tages med for lidt væske.
English: The HMPC conclusions on the use of ispaghula seed medicines are based on their ‘well-established use' in these conditions.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med ispaghula-frø er baseret på deres "almindelig anerkendte anvendelse" til disse tilstande.
English: It can be used in adults and children above the age of 6 years.
Danish: Ispaghula-frø kan anvendes hos voksne og børn over 6 år.
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Danish: Nærmere oplysninger om de undersøgelser, HPMC har vurderet, findes i HPMC's vurderingsrapport.
English: Ispaghula seed
Danish: Ispaghula-frø
English: In its assessment of ispaghula seed to treat constipation, the HMPC considered a number of clinical studies that were carried out with ispaghula husk which contains the same ingredients.
Danish: I sin vurdering af ispaghula-frø til behandling af forstoppelse gennemgik HMPC en række kliniske undersøgelser, som blev udført med ispaghula-frøskaller, der har samme indholdsstoffer.
English: Information on the use and licensing of ispaghula seed medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om anvendelse og godkendelse i EU's medlemsstater af lægemidler, der indeholder ispaghula-frø, skal indhentes fra de relevante nationale myndigheder.
English: Any applications for the licensing of medicines containing ispaghula seed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder ispaghula-frø, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Allergic reactions including rhinitis (runny nose), conjunctivitis (reddening and inflammation of the white of the eye), bronchospasm (excessive and prolonged contraction of the airway muscles) and anaphylaxis (severe allergic reaction) may also occur.
Danish: Desuden kan der forekomme allergiske reaktioner i form af løbende næse (rhinitis)), røde og irriterede øjne (konjunktivitis), vejrtrækningsbesvær (bronkospasme) og svær allergisk reaktion (anafylaksi).
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of ispaghula seed.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af ispaghula-frø.
English: It should also not be used in patients with conditions that involve a narrowing of the stomach and gut, and patients who have difficulty swallowing or have problems with their throat.
Danish: De bør heller ikke anvendes til patienter med sygdomme, der medfører forsnævring i mave-tarm-systemet, eller til patienter med halsproblemer eller vanskeligheder ved at synke.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing ispaghula seed.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder ispaghula-frø.
English: Further information on the HMPC assessment of ispaghula seed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder ispaghula-frø, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Ispaghula seed is used in the form of whole, dried, seeds or as preparations obtained by powdering the seeds.
Danish: Ispaghula-frø anvendes i form af hele, tørrede frø eller forarbejdes ved pulverisering af frøene.
English: Further information on the risks associated with ispaghula seed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder ispaghula-frø, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Herbal medicines containing ispaghula seed are usually available in solid forms to be taken by mouth.
Danish: Plantelægemidler med ispaghula-frø fås sædvanligvis i fast form til indtagelse gennem munden.
English: What is ispaghula seed?
Danish: Hvad er ispaghula-frø?
English: Detailed instruction on how to take ispaghula seed medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler med ispaghula-frø skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: How does ispaghula seed work as a medicine?
Danish: Hvordan virker ispaghula-frø som lægemiddel?
English: Other information about ispaghula seed medicines
Danish: Andre oplysninger om lægemidler, der indeholder ispaghula-frø
English: The HMPC recommended that ispaghula seed should not be used in patients with a sudden change in bowel habit that persists for more than two weeks, and in patients with undiagnosed bleeding of the rectum and failure to pass stools following the use of a laxative.
Danish: HMPC anbefaler, at ispaghula-frø ikke anvendes til patienter med pludseligt ændrede afføringsvaner, der varer i mere end to uger; eller til patienter der af ukendt årsag har blødning fra endetarmen; eller manglende evne til at komme af med afføringen efter brug af afføringsmiddel.
English: Ispaghula husk has been studied in over 900 patients showing effectiveness as a mild laxative.
Danish: Ispaghulafrøskallerne er blevet undersøgt hos mere end 900 patienter, og det er blevet påvist, at virke som et mildt afføringsmiddel.
English: The HMPC concluded that ispaghula seed can be used for the treatment of habitual constipation (constipation not caused by a physical change to an organ) and in conditions where softening of the stools is desirable to reduce pain when they are passed, such as anal fissures, haemorrhoids and after surgery to the anus or rectum.
Danish: HMPC konkluderede, at ispaghula-frø kan anvendes til behandling af ofte tilbagevendende forstoppelse (der ikke skyldes en fysisk ændring i et organ) og ved tilstande, hvor det ønskes at bløgøre afføringen for at nedsætte smerter ved passage, såsom rifter i endetarmsåbningen (analfissurer) og hæmorroider samt efter operationer i endetarmen og eller tarmåbningen.Ispaghula-frø skal indtages med rigelig væske.
English: This summary is not intended to provide practical advice on how to use medicines containing ispaghula seed.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder ispaghula-frø, anvendes.
English: How are ispaghula seed medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder ispaghula-frø, i EU?
English: Ispaghula seed contains dietary fibre which when mixed with water forms a gel-like mass that works as a mild laxative (medicine used to treat constipation).
Danish: Ispaghula-frø indeholder kostfibre, som ved opblanding med vand danner en geléagtig masse, der virker som et mildt afføringsmiddel .
English: Side effects have been reported with ispaghula seed medicines, including flatulence and abdominal distension (swelling of the belly).
Danish: Ved brug af lægemidler med isphagulafrø er beskrevet bivirkninger, herunder tarmluft og oppustethed.
English: What evidence supports the use of ispaghula seed medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af lægemidler med ispaghula-frø?
English: For more information about treatment with ispaghula seed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder ispaghulafrø, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: What are the risks associated with ispaghula seed medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder ispaghulafrø?
English: For practical information about using ispaghula seed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med ispaghula-frø, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The data on ispaghula husk support therefore the use of ispaghula seed as a laxative.The effectiveness of ispaghula seed in softening stools is based on its laxative effects and no specific data are available.
Danish: Ispaghula-frøenes evne til at blødgøre afføring er baseret på den afførende virkning, men der findes ingen specifikke oplysninger herom.
English: At the same time ispaghula seed lubricates the intestine which improves the transit of stools.
Danish: Samtidig smøres tarmen, hvilket forbedrer passagen af afføreingen.
English: The full EPAR for Levetiracetam Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Levetiracetam Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For patients weighing less than 50 kg, the dose depends on body weight.
Danish: Hos patienter, der vejer under 50 kg, afhænger dosis af legemsvægten.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Teva on 26 August 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levetiracetam Teva den 26. august 2011.
English: The exact way in which levetiracetam works is still unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells.
Danish: Det vides endnu ikke nøjagtigt, hvordan levetiracetam virker, men det bindes til proteinet synaptisk vesikelprotein 2A, som medvirker ved udskillelsen af kemiske signalstoffer fra nervecellerne.