FrancophonIA/ELRC3.0 huggingface dataset:
English: What benefit has Herceptin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Herceptin?
English: How has Herceptin been studied?
Danish: Hvordan blev Herceptin undersøgt?
English: What is Herceptin used for?
Danish: Hvad anvendes Herceptin til?
English: HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Danish: Cirka en fjerdedel af brystkræfttilfældene og en femtedel af tilfældene af mavekræft overudtrykker HER2.
English: How is Herceptin used?
Danish: Hvordan anvendes Herceptin?
English: How does Herceptin work?
Danish: Hvordan virker Herceptin?
English: Herceptin was given before surgery and the main measure of effectiveness was response to treatment assessed by measuring the proportion of patients who had no cancerous cells found on examination of the breast removed by surgery.
Danish: Responsen blev målt på grundlag af den andel af patienter, hos hvem, der ikke blev fundet nogen cancerceller, da brystet blev undersøgt, efter at det var blevet fjernet kirurgisk.
English: • not known: frequency cannot be estimated from the available data.
Danish: • ikke kendt: kan ikke estimeres ud fra forhåndenværende data.
English: Side effects may occur with certain frequencies, which are defined as follows:
Danish: Bivirkninger kan opstå med visse frekvenser, som defineres som følger:
English: Moreover, the safety profile of Clopidogrel in this subgroup of patients did not raise any particular concern.
Danish: Derudover gav sikkerhedsprofilen for denne patientundergruppe ikke anledning til særlig bekymring.
English: The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimisation activities have been identified.
Danish: Ansøgningen er baseret på et reference-lægemiddel, hvor der ikke er identificeret nogen sikkerhedsproblemer, som kræver yderligere risikominimerings aktiviteter.
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer,
English: Esomeprazole is expected to give a similar interaction with Clopidogrel.
Danish: Esomeprazol forventes at give en lignende interaktion med Clopidogrel.
English: PSURs The PSUR submission schedule should follow the PSUR schedule for the reference product.
Danish: PSUR'er Planen for PSUR-indsendelse skal følge planen for PSUR-indsendelse for referenceproduktet
English: Chinese (n=573)
Danish: Kinesisk (n=573)
English: The most common side effect (affects 1 to 10 patients in 100) reported with Clopidogrel is bleeding.
Danish: Den mest almindelige bivirkning (hos 1 til 10 patienter ud af 100) der er set med Clopidogrel er blødning.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i ansøgningen om markedsføringstilladelsen (version 3.0, Modul 1.8.1), er på plads og fungerer, før og mens produktet markedsføres.
English: The incidence of severe cases was 1.4% for Clopidogrel and 1.6% for ASA.
Danish: Forekomsten af svære tilfælde var 1,4 % for Clopidogrel og 1,6 % for ASA.
English: Their frequency is defined using the following conventions: 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).
Danish: Hyppighed defineres i henhold til følgende konvention: almindelig (>1/100 til <1/10), ikke almindelig (>1/1.000 til <1/100), sjælden (>1/10.000 til <1/10.000), meget sjælden
English: Analysis of total mortality as a secondary endpoint did not show any significant difference between Clopidogrel (5.8%) and ASA (6.0%).
Danish: En analyse med total mortalitet som sekundært endpoint viste ingen signifikant forskel mellem Clopidogrel (5,8 %) og ASA (6,0 %).
English: If you suffer from severe liver disease.
Danish: • Hvis De lider af alvorlig leversygdom.
English: However, Clopidogrel and ASA have been administered together for up to one year (see section
Danish: Imidlertid er Clopidogrel og ASA givet samtidig i op til et år (se pkt.
English: Black (n=966)
Danish: Negroid (n=966)
English: The safety and efficacy of Clopidogrel in children and adolescents have not yet been established.
Danish: • Børn og unge Sikkerhed og virkning af Clopidogrel hos børn og unge er endnu ikke fastslået.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Acino Pharma GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Acino Pharma GmbH
English: As no clinical data on exposure to Clopidogrel during pregnancy are available, it is preferable not to use Clopidogrel during pregnancy as a precautionary measure.
Danish: Da der ikke foreligger kliniske data om eksponering for Clopidogrel under graviditet, foretrækkes det, at Clopidogrel ikke anvendes under graviditet af sikkerhedsmæssige årsager.
English: In addition, a subgroup analysis by age suggested that the benefit of Clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Danish: Endvidere tydede en analyse af aldersbaserede delgrupper på, at fordelen ved Clopidogrel hos patienter over 75 år var mindre end hos patienter ≤75 år.
English: Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany
Danish: Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Tyskland
English: • If you are allergic (hypersensitive) to Clopidogrel or any of the other ingredients of Clopidogrel 1A Pharma;
Danish: • Hvis De er overfølsom (allergisk) over for Clopidogrel eller et af de øvrige indholdsstoffer i Clopidogrel 1A Pharma.
English: Taking Clopidogrel 1A Pharma with food and drink Clopidogrel 1A Pharma may be taken with or without food.
Danish: Brug af Clopidogrel 1A Pharma sammen med mad og drikke Clopidogrel 1A Pharma kan tages med eller uden mad.
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 dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: Absorption is at least 50%, based on urinary excretion of Clopidogrel metabolites.
Danish: Absorptionen er mindst 50% baseret på udskillelse af Clopidogrels metabolitter i urinen.
English: When given to lactating rats, Clopidogrel caused a slight delay in the development of the offspring.
Danish: Når diegivende rotter fik Clopidogrel, opstod der en mindre forsinkelse i ungernes udvikling.
English: Overdose following Clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications.
Danish: Overdosering efter administration af Clopidogrel kan føre til forlænget blødningstid og efterfølgende blødningskomplikationer.
English: Overall, Clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Danish: Samlet set var Clopidogrel 75 mg/dag sammenligneligt med ASA 325 mg/dag i CAPRIE, uden hensyntagen til alder, køn eller race.
English: In another study it was shown that administering Clopidogrel and omeprazole 12 hours apart did not prevent their interaction that is likely to be driven by the inhibitory effect of omeprazole on CYP2C19.
Danish: I et andet studie blev det vist, at administration af Clopidogrel og omeprazol med 12 timers mellemrum ikke hindrede deres interaktion, som sandsynligvis skyldes omeprazols hæmmende effekt på CYP2C19.
English: If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, Clopidogrel should be discontinued 7 days prior to surgery.
Danish: For patienter, der skal have foretaget elektiv kirurgi, og hvor en midlertidig antitrombotisk effekt ikke er ønskelig, bør Clopidogrel seponeres 7 dage før indgrebet.
English: Some other medicines may influence the use of Clopidogrel 1A Pharmaor vice versa.
Danish: Visse andre typer medicin kan påvirke brugen af Clopidogrel 1A Pharma eller omvendt.
English: Excipients: each tablet contains 3.80 mg hydrogenated castor oil.
Danish: Hjælpestoffer: hver tablet indeholder 3,80 mg hydrogeneret ricinusolie.
English: Other side effects reported with Clopidogrel are: -Common side effects:
Danish: Øvrige bivirkninger ved Clopidogrel: - Almindelige bivirkninger:
English: After single and repeated oral doses of 75 mg per day, Clopidogrel is rapidly absorbed.
Danish: Efter enkelt og gentagne orale doser på 75 mg/dag bliver Clopidogrel hurtigt absorberet.
English: In CLARITY and one of the cohort studies (n = 765; Trenk), cardiovascular event rates did not differ significantly by genotype.
Danish: I CLARITY og et af kohortestudierne (n=765; Trenk) var der ingen signifikant forskel i kardiovaskulære hændelser genotyperne imellem.
English: Do not use Clopidogrel 1A Pharma if you notice any visible sign of damage of blister or film-coated tablets.
Danish: Brug ikke Clopidogrel 1A Pharma hvis De bemærker synlige tegn på skade på blisterpakningen eller de filmovertrukne tabletter.
English: Apart from the specific medicinal products interaction information described above, interaction studies with Clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
Danish: Ud over ovenstående oplysninger om specifik lægemiddelinteraktion er der ikke udført interaktionsforsøg med Clopidogrel og visse lægemidler, som almindeligvis gives til patienter med aterotrombotiske sygdomme.
English: Heparins were administered in more than 90% of the patients and the relative rate of bleeding between Clopidogrel and placebo was not significantly affected by the concomitant heparin therapy.
Danish: Heparin blev givet til over 90 % af patienterne, og den relative blødningsforekomst i Clopidogrel- og placebogruppen blev ikke signifikant påvirket af den ledsagende heparinbehandling.
English: Children and adolescents Clopidogrel 1A Pharma is not intended for use in children or adolescents.
Danish: Børn og unge Clopidogrel 1A Pharma må ikke gives til børn og unge.
English: After a single oral dose of 75 mg, Clopidogrel has a half-life of approximately 6 hours.
Danish: Efter en enkelt dosering på 75 mg har Clopidogrel en halveringstid på ca. 6 timer.
English: 4.1 Therapeutic indications Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
Danish: Clopidogrel er indiceret hos voksne til forebyggelse af aterotrombotiske hændelser hos:
English: It is unknown whether Clopidogrel is excreted in human breast milk.
Danish: Det vides ikke, om Clopidogrel udskilles i modermælk hos mennesker.
English: In the fifth cohort study (n = 2,208; Simon), the increased event rate was observed only in poor metabolisers.
Danish: I det femte kohortestudie (n=2.208; Simon) blev der kun set en øget forekomst af sådanne hændelser hos patienter med ringe metabolisme.
English: However, concomitant administration of 500 mg of ASA twice a day for one day did not significantly increase the prolongation of bleeding time induced by Clopidogrel intake.
Danish: Samtidig indgift af 500 mg ASA to gange daglig på en enkelt dag øgede imidlertid ikke signifikant den forlængede kapillærblødningstid, som indgift af Clopidogrel bevirkede.
English: The safety and efficacy of Clopidogrel have been evaluated in 4 double-blind studies involving over 80,000 patients: the CAPRIE study, a comparison of Clopidogrel to ASA, and the CURE, CLARITY and COMMIT studies comparing Clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Danish: Sikkerheden og effekten af clopidrogrel er blevet evalueret i 4 dobbeltblindede forsøg, der omfattede mere end 80.000 patienter i CAPRIE-undersøgelsen, hvor Clopidogrel sammenlignes med ASA, og CURE, CLARITY og COMMIT-undersøgelserne, hvor Clopidogrel sammenlignes med placebo, og hvor begge lægemidler gives i kombination med ASA eller anden standardterapi.
English: The association between CYP2C19 genotype and Clopidogrel treatment outcome was evaluated in 2 post hoc clinical trial analyses (substudies of CLARITY [n = 465] and TRITON-TIMI 38 [n = 1,477]) and 5 cohort studies (total n = 6,489).
Danish: Sammenhængen mellem CYP2C19-genotype og udfald af Clopidogrelbehandlingen blev evalueret i 2 kliniske post-hoc analyser (substudier af CLARITY [n=465] og TRITON-TIMI 38 [n=1.477]) og 5 kohortestudier (total n=6.489).
English: Several polymorphic CYP450 enzymes activate Clopidogrel.
Danish: Adskillige polymorfe CYP450-enzymer aktiverer Clopidogrel.
English: There was no evidence of carcinogenic effect when Clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Danish: Der var ikke tegn på karcinogen virkning, når Clopidogrel blev administreret i 78 uger til mus og 104 uger til rotter og givet i doser op til 77 mg/kg/dag (hvilket udgør mindst 25 gange eksponeringen hos mennesker, der får den kliniske dosis på 75 mg/dag).
English: To date, the impact of CYP2C19 genotype on the pharmacokinetics of the active metabolite of Clopidogrel has been evaluated in 227 subjects from 7 reported studies.
Danish: Indtil i dag er effekten af CYP2C19-genotypen på farmakokinetikken af Clopidogrels aktive metabolit blevet evalueret hos 227 individer fra 7 rapporterede studier.
English: If you stop taking Clopidogrel 1A Pharma Do not stop the treatment.
Danish: Hvis De holder op med at tage Clopidogrel 1A Pharma De må ikke ophøre med behandlingen.
English: If you forget to take a dose of Clopidogrel 1A Pharma, but remember within 12 hours of your usual time, take your tablet straight away and then take your next tablet at the usual time.
Danish: Hvis De har glemt at tage Clopidogrel 1A Pharma Hvis De glemmer at tage en dosis Clopidogrel 1A Pharma til sædvanlig tid, men kommer i tanke om det i løbet af 12 timer, skal De omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: Like all medicines, Clopidogrel 1A Pharma can cause side effects, although not everybody gets them.
Danish: Clopidogrel 1A Pharma kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: No clinically significant pharmacodynamic interactions were observed when Clopidogrel was co-administered with atenolol, nifedipine, or both atenolol and nifedipine.
Danish: Der blev ikke observeret nogen klinisk signifikante farmakodynamiske interaktioner, når Clopidogrel blev indgivet samtidig med atenolol, nifedipin eller både atenolol og nifedipin.
English: A number of other clinical studies have been conducted with Clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Danish: Andre lægemidler: Der er gennemført en række andre kliniske forsøg med Clopidogrel og anden samtidig medicinering for at undersøge muligheden for farmakodynamisk og farmakokinetisk interaktion.
English: Thrombolytics: the safety of the concomitant administration of Clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction.
Danish: Trombolytika: Sikkerheden ved samtidig administration af Clopidogrel, fibrin eller nonfibrinspecifikke trombolytiske midler og hepariner blev bedømt hos patienter med akut myokardieinfarkt.
English: Do not use Clopidogrel 1A Pharma after the expiry date which is stated on the carton and on the blister after EXP.
Danish: Brug ikke Clopidogrel 1A Pharma efter den udløbsdato, som er angivet på æsken og blisterpakningen.
English: No effect on hepatic metabolising enzymes was observed in humans receiving Clopidogrel at the therapeutic dose.
Danish: Der blev ikke observeret nogen effekt på levermetaboliseringsenzymerne hos mennesker, der havde fået Clopidogrel i terapeutiske doser.
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the Clopidogrel treated group and 363 (5.8%) in the placebo treated group].
Danish: Fordelen må hovedsageligt tilskrives den statistisk signifikante reduktion i forekomsten af myokardieinfarkt [287 (4,6 %) i Clopidogrelgruppen og 363 (5,8 %) i placebogruppen].
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide can be safely co-administered with Clopidogrel.
Danish: Data fra CAPRIE-undersøgelsen indikerer, at phenytoin og tolbotamid uden risiko kan administreres samtidig med Clopidogrel.
English: There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers (except cimetidine which is a CYP2C19 inhibitor) or antacids interfere with antiplatelet activity of Clopidogrel.
Danish: Der foreligger ikke beviser for, at andre lægemidler, der reducerer mavesyren, såsom H2-blokkere (med undtagelse af cimetidin, der er en CYP2C19-hæmmer) eller antacida, påvirker Clopidogrels antitrombotiske aktivitet.
English: Thus, beyond 3 months of treatment, the benefit observed in the Clopidogrel + ASA group was not further increased, whereas the risk of haemorrhage persisted (see section 4.4).
Danish: Efter 3 måneders behandling blev den observerede fordel således ikke yderligere forbedret i Clopidogrel+ASA-gruppen, hvorimod der stadig forelå en blødningsrisiko (se pkt.
English: No conclusive data on the pharmacodynamic interaction of Clopidogrel and other PPIs are available.
Danish: Der foreligger ingen konklusive data vedrørende farmakodynamisk interaktion mellem Clopidogrel og andre PPI'er.
English: The exposure to the active metabolite of Clopidogrel was decreased by 45% (Day 1) and 40% (Day 5) when Clopidogrel and omeprazole were administered together.
Danish: Eksponeringen for Clopidogrels aktive metabolit faldt med 45 % (dag 1) og 40 % (dag 5), når Clopidogrel og omeprazol blev administeret sammen.
English: In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for Clopidogrel+ASA, and 6.3% for placebo+ASA.
Danish: Hos patienter, som fortsatte med behandlingen indtil 5 dage før bypassoperationen, var forekomsten 9,6 % for Clopidogrel+ASA og 6,3 % for placebo+ASA.
English: Clopidogrel significantly reduced the relative risk of death from any cause by 7% (p = 0.029), and the relative risk of the combination of re-infarction, stroke or death by 9% (p = 0.002), representing an absolute reduction of 0.5% and 0.9%, respectively.
Danish: Clopidogrel reducerede signifikant den relative dødsrisiko uanset årsag med 7 % (p=0,029) og den relative risiko for kombinationen af re-infarkt, slagtilfæde eller død med 9 % (p=0,002), hvilket repræsenterer en absolut reduktion på henholdsvis 0,5 % og 0,9 %.
English: Specific pharmacokinetic studies performed with radiolabelled Clopidogrel have shown that the parent compound or its metabolites are excreted in the milk.
Danish: Specifikke farmakokinetiske forsøg med radioaktivt mærket Clopidogrel har vist, at udgangsstoffet eller dets metabolitter udskilles i mælk.
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel 1A Pharma.
Danish: Hvis De er gravid eller har mistanke om, at De kan være gravid, skal De fortælle det til Deres læge eller apoteket, før De tager Clopidogrel 1A Pharma.
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Take special care with Clopidogrel 1A Pharma').
Danish: Hvis De er bekymret over Deres blødning, skal De omgående kontakte Deres læge (se afsnit 2 'Vær ekstra forsigtig med at tage Clopidogrel 1A Pharma').
English: NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of Clopidogrel and naproxen increased occult gastrointestinal blood loss.
Danish: NSAID'er: I et klinisk forsøg foretaget på raske forsøgspersoner øgede den samtidige administration af Clopidogrel og naproxen okkult gastrointestinalt blodtab.
English: If you take more Clopidogrel 1A Pharma than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Danish: Hvis De har taget for meget Clopidogrel 1A Pharma Kontakt Deres læge eller tag på den nærmeste skadestue på grund af den øgede blødningsrisiko.
English: In patients with acute ST-segment elevation MI, safety and efficacy of Clopidogrel have been evaluated in 2 randomised, placebo-controlled, double-blind studies, CLARITY and COMMIT.
Danish: Hos patienter med akut myokardieinfarkt (MI) med ST-segment elevation blev sikkerheden ved og effekten af clopidrogrel vurderet i 2 randomiserede, placebo-kontrollerede, dobbeltblindede undersøgelser kaldet CLARITY og COMMIT.
English: In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, Clopidogrel was numerically inferior, but not statistically different from ASA (RRR = -4.0%; CI: -22.5 to 11.7 [p = 0.639]).
Danish: Hos de patienter, som alene indgik i undersøgelsen på grund af et nyligt myokardieinfarkt, lå Clopidogrel numerisk lavere, men ikke statistisk forskelligt fra ASA (RRR = 4,0 %, CI: -22,5 til 11,7 [p=0,639]).
English: CYP2C19 poor metaboliser status is associated with diminished response to Clopidogrel.
Danish: Status som 'CYP2C19 poor metaboliser' er forbundet med nedsat respons på Clopidogrel.
English: In view of the lack of data, Clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Danish: På grund af manglende data kan Clopidogrel ikke anbefales til akut iskæmisk slagtilfælde (inden for 7 dage efter iskæmisk stroke).
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE
Danish: • Skal De også fortælle det til Deres læge med det samme, hvis De udvikler en medicinsk tilstand (trombocytisk trombocytopenisk purpura eller TTP), der giver feber og blå mærker under huden, der kan fremstå som små røde prikker, med eller uden uforklarlig ekstrem træthed, forvirring, gulning af huden eller øjnene (gulsot) (se afsnit 4'BIVIRKNINGER')
English: There may be genetic variants of other CYP450 enzymes with effects on the ability to form the active metabolite of Clopidogrel.
Danish: Der kan forekomme genetiske varianter af andre CYP450-enzymer med indflydelse på evnen til at danne den aktive metabolit af Clopidogrel.
English: Furthermore, the pharmacodynamic activity of Clopidogrel was not significantly influenced by the coadministration of phenobarbital, or oestrogen.
Danish: Herudover blev Clopidogrels farmakodynamiske aktivitet ikke påvirket signifikant af samtidig administration af phenobarbital eller østrogen.
English: Pharmacogenetics: Based on literature data, patients with genetically reduced CYP2C19 function have lower systemic exposure to the active metabolite of Clopidogrel and diminished antiplatelet responses, and generally exhibit higher cardiovascular event rates following myocardial infarction than do patients with normal CYP2C19 function (see section 5.2).
Danish: Farmakogenetik: Baseret på data fra litteraturen har patienter med genetisk nedsat funktion af CYP2C19 lavere systemisk eksponering for Clopidogrels aktive metabolit, nedsat antitrombotisk respons og udviser generelt højere frekvens af kardiovaskulære hændelser efter myokardieinfarkt, end patienter med normal funktion af CYP2C19 (se pkt.
English: Elimination Following an oral dose of 14C-labelled Clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Danish: Elimination Efter en oral dosis af 14C-mærket Clopidogrel hos mennesker blev ca. 50 % udskilt i urinen og ca. 46