FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who have received Orbactiv must not be given an infusion of unfractionated heparin (a medicine used to prevent blood clots) for 120 hours after the infusion of Orbactiv.
Danish: Patienter, der har fået Orbactiv, må ikke få infusion med ufraktioneret heparin (et lægemiddel, der anvendes til at forhindre blodpropper) i 120 timer efter infusionen af Orbactiv.
English: What measures are being taken to ensure the safe and effective use of Orbactiv?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Orbactiv?
English: Although Orbactiv's safety profile overall is similar to that of other glycopeptides, the CHMP noted that some side effects occurred more frequently such as abscesses and bone infections.
Danish: Skønt sikkerhedsprofilen af Orbactiv overordnet svarer til andre glykopeptiders, bemærkede CHMP, at nogle bivirkninger forekom oftere, såsom abscesser og knogleinfektioner.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Danish: Det forklarer, hvordan agenturet vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse i EU og til sine anbefalinger om, hvordan lægemidlet skal anvendes.
English: In addition, 82.7% of patients treated with Orbactiv in the first study and 79.6% in the second study were cured, compared with 80.5% and 80.0% respectively of patients treated with vancomycin.
Danish: Desuden blev 82,7 % af de patienter, der blev behandlet med Orbactiv i den første undersøgelse, og 79,6 % i den anden undersøgelse, helbredt, sammenlignet med henholdsvis 80,5 % og 80,0 % af de patienter, der blev behandlet med vancomycin.
English: It is not intended to provide practical advice on how to use Orbactiv.
Danish: Det er ikke en praktisk vejledning i, hvordan Orbactiv bør anvendes.
English: What are the risks associated with Orbactiv?
Danish: Hvilke risici er der forbundet med Orbactiv?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Orbactiv, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Orbactiv, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The active substance in Orbactiv, oritavancin, is a type of antibiotic called a glycopeptide.
Danish: Det aktive stof i Orbactiv, oritavancin, er et antibiotikum af glykopeptidtypen.
English: The most common side effects that resulted in treatment being stopped were cellulitis and osteomyelitis (bone infection).
Danish: De bivirkninger, der oftest medførte standsning af behandlingen, var cellulitis og knoglemarvsbetændelse (osteomyelitis).
English: The CHMP considered that Orbactiv, which can be given as a single dose, could be a valuable alternative treatment option for acute bacterial infections of the skin and of skin structures.
Danish: CHMP fandt, at Orbactiv, der kan gives som en enkelt dosis, kan være et værdifuldt behandlingsalternativ ved akutte bakterielle infektioner i huden og det underliggende væv.
English: The most common side effects with Orbactiv (which may affect 5 people or more in 100) are nausea (feeling sick), hypersensitivity (allergy) reactions or reactions at the site of infusion and headache.
Danish: De hyppigste bivirkninger ved Orbactiv (som optræder hos mere end 5 ud af 100 patienter) er kvalme, allergiske reaktioner (overfølsomhedsreaktioner) eller reaktioner på infusionsstedet og hovedpine.
English: A list of bacteria against which Orbactiv is active can be found in the summary of product characteristics (also part of the EPAR).
Danish: En liste over de bakterier, som Orbactiv virker mod, findes i produktresuméet (også en del af denne EPAR).
English: For more information about treatment with Orbactiv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Orbactiv, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In both studies, the main measure of effectiveness was the number of patients who responded within 3 days of starting treatment with an improvement in their skin in the infected area, lack of fever and no need for additional antibiotic.
Danish: I begge undersøgelser blev virkningen hovedsagelig bedømt på det antal patienter, hos hvem behandlingen virkede inden for tre dage, efter at den var påbegyndt, dvs. hvor der sås bedring af de angrebne hudområder, og patienterne var feberfrie og ikke behøvede supplerende behandling med antibiotika.
English: Orbactiv, given as a single infusion, was compared with a 7 to 10-day treatment with vancomycin (another glycopeptide) in two main studies involving a total of around 1,959 patients with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections.
Danish: En enkelt infusion af Orbactiv blev sammenlignet med 7-10-dages behandling med et andet glykopeptid (vancomycin) i to hovedundersøgelser med i alt 1 959 patienter med akutte bakterielle infektioner i huden og det underliggende væv, såsom cellulitis, hudabscesser og sårinfektioner.
English: Orbactiv is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Danish: Orbactiv er et antibiotikum til behandling af voksne med kortvarige (akutte) bakterielle infektioner i huden og de underliggende hudstrukturer, såsom betændelse i de dybe lag af huden (cellulitis), bylder (hudabscesser) og sårinfektioner.
English: Orbactiv has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work.
Danish: Det er påvist, at Orbactiv virker mod bakterier, som sædvanlige antibiotika ikke virker imod (såsom meticillinresistente Staphylococcus aureus (MRSA)).
English: Orbactiv was at least as effective as vancomycin at treating the infection: 80.1% of patients treated with Orbactiv in the first study and 82.3% in the second study responded to treatment, compared with 82.9% and 78.9% respectively of patients treated with vancomycin.
Danish: Behandlingen virkede hos 80,1 % af de patienter, der blev behandlet med Orbactiv i den første undersøgelse, og hos 82,3 % i den anden undersøgelse, sammenlignet med henholdsvis 82,9 % og 78,9 % af de patienter, der blev behandlet med vancomycin.
English: For practical information about using Orbactiv, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Orbactiv, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Orbactiv used?
Danish: Hvordan anvendes Orbactiv?
English: What benefits of Orbactiv have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Orbactiv?
English: For the full list of all side effects and restrictions with Orbactiv, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Orbactiv fremgår af indlægssedlen.
English: How does Orbactiv work?
Danish: Hvordan virker Orbactiv?
English: Orbactiv is available as a powder to be made up into a solution for infusion (drip) into a vein and can only be obtained with a prescription.
Danish: Orbactiv fås som et pulver, der blandes til en infusionsvæske, opløsning (drop i en vene).
English: Date of latest renewal: 22 May 2014
Danish: Dato for seneste fornyelse: 22. maj 2014
English: • if you have had an allergy or reaction to any medicine used to treat your disease.
Danish: • hvis du har haft allergi over for eller en reaktion på et lægemiddel, der anvendes til at behandle din sygdom.
English: • Adults and elderly
Danish: Dosering • Voksne og ældre
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), not known (cannot be estimated from the available data).
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 <1/1.000); meget sjælden <1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Contact your doctor immediately if you experience: fever, signs of infection or extreme tiredness.
Danish: Kontakt din læge med det samme, hvis du oplever: feber, tegn på infektion eller udtalt træthed.
English: Some other medicines may influence the use of Clopidogrel Mylan or vice versa.
Danish: Visse andre lægemidler kan påvirke brugen af Clopidogrel Mylan eller omvendt.
English: PHARMACEUTICAL FORM Film-coated tablet.
Danish: LÆGEMIDDELFORM Filmovertrukket tablet.
English: Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks.
Danish: Kombinationsterapi bør startes så tidligt som muligt, og fortsættes i mindst 4 uger efter symptomerne viser sig.
English: Clopidogrel has been evaluated for safety in more than 44,000 patients, who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Danish: Clopidogrel er blevet evalueret sikkerhedsmæssigt hos mere end 44.000 patienter, der har deltaget i kliniske studier, inklusive over 12.000 patienter, der blev behandlet i mindst 1 år.
English: • Your doctor may order blood tests.
Danish: • kan din læge foreskrive, at der tages blodprøver.
English: • You should tell your doctor if a surgery (including dental) is planned.
Danish: • skal du fortælle din læge, hvis du skal have foretaget en planlagt operation (herunder tandoperation).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2009
Danish: Dato for første tilladelse: 21. september 2009
English: You should take Clopidogrel Mylan for as long as your doctor continues to prescribe it.
Danish: Du skal tage Clopidogrel Mylan, så længe som din læge fortsætter med at ordinere det.
English: TOPIC and TROPICAL-ACS were designed to study how to mitigate the bleeding events while maintaining efficacy.
Danish: TOPIC og TROPICAL-ACS blev designet til at undersøge, hvordan man kan mindske blødninger samtidig med at effekten opretholdes.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month post-ACS.
Danish: I modsætning hertil viste post-hoc analyser statistisk signifikante stigninger i blødningsrisikoen med de mere potente P2Y12hæmmere, overvejende under vedligeholdelsesfasen efter den første måned efter ACS.
English: BATCH NUMBER
Danish: BATCHNUMMER Batch
English: Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Danish: Absorptionen er mindst 50 % baseret på urinudskillelse af clopidogrels metabolitter.
English: Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
Danish: Ca. 88 % af patienterne fik samtidig ASA (interval 1 til 23 mg/kg/dag).
English: • if you suffer from severe liver disease;
Danish: • hvis du lider af en alvorlig leversygdom.
English: At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
Danish: Ved steady state var den gennemsnitlige hæmningsgrad, der blev iagttaget med en dosis på 75 mg/dag, mellem 40 % og 60 %.
English: Cellulose, microcrystalline Colloidal anhydrous silica Crospovidone (type A) Macrogol 6000
Danish: Cellulose, mikrokrystallinsk Silica, kolloid vandfri Crospovidon (type A) Macrogol 6000
English: Warnings and precautions Talk to your doctor before taking Clopidogrel Mylan if any of the situations mentioned below apply to you:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Clopidogrel Mylan, hvis nogen af følgende situationer gælder for dig:
English: The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
Danish: Den aktive metabolit dannes hovedsageligt af CYP2C19 med bidrag fra flere andre CYP-enzymer, inklusive CYP1A2, CYP2B6 og CYP3A4.
English: For patients who did not undergo angiography, the primary endpoint was death or recurrent myocardial infarction by Day 8 or by hospital discharge.
Danish: For de patienter der ikke gennemgik angiografi, var det primære endepunkt død, gentaget myokardieinfarkt ved dag 8 eller ved udskrivelse fra hospitalet.
English: Pink, round and biconvex film-coated tablets.
Danish: Lyserøde, runde og bikonvekse filmovertrukne tabletter.
English: Your doctor should have prescribed Clopidogrel Mylan plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Danish: Din læge bør have udskrevet Clopidogrel Mylan plus acetylsalicylsyre, hvis du ikke må tage ”orale antikoagulantia”, og du ikke har risiko for alvorlig blødning.
English: The population included 27.8% women, 58.4% patients ≥ 60 years (26% ≥ 70 years) and 54.5% patients who received fibrinolytics.
Danish: Populationen inkluderede 27,8 % kvinder, 58,4 % patienter ≥ 60 år (26 % ≥ 70 år) og 54,5 % patienter der fik fibrinolytika.
English: If you experience prolonged bleeding when taking Clopidogrel Mylan If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: Hvis du får langvarige blødninger, mens du tager Clopidogrel Mylan Hvis du skærer dig eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
English: In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Danish: Hos poor metabolisers var eksponeringen nedsat med 63-71 %, sammenlignet med personer med extensive metabolisers.
English: Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and clopidogrel should be discontinued
Danish: Patienter med en bekræftet diagnose på erhvervet hæmofili skal varetages og behandles af specialister, og clopidogrel skal seponeres.
English: 7 film-coated tablets - calendar blister: EU/1/09/559/012 14 film-coated tablets - calendar blister: EU/1/09/559/013 28 film-coated tablets - calendar blister: EU/1/09/559/014 56 film-coated tablets - calendar blister: EU/1/09/559/015 84 film-coated tablets - calendar blister: EU/1/09/559/016
Danish: 7 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559/012 14 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559/013 28 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559/014 56 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559015 84 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559/016
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 30x1 film-coated tablets 50 film-coated tablets 50x1 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Danish: 7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 30x1 filmovertrukne tabletter 50 filmovertrukne tabletter 50x1 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Danish: De klinisk relevante bivirkninger observeret i CAPRIE-, CURE-, CLARITY, COMMITog ACTIVE-A-studierne beskrives nedenfor.
English: Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
Danish: Polyvinylalkohol Titandioxid (E171) Rød jernoxid (E172) Gul jernoxid (E172) Talcum
English: In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Danish: I CURE, CLARITY, ACTIVE-A og et af kohortestudier (Trenk) blev der ikke observeret nogen øget forekomst af hændelser, baseret på metabolismestatus.
English: • Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
Danish: • Pædiatrisk population Clopidogrels bør ikke bruges til børn på grund af usikkerhed om virkningen (se pkt.
English: If you forget to take a dose of Clopidogrel Mylan, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Danish: Hvis du har glemt en dosis af Clopidogrel Mylan, men kommer i tanke om det i løbet af 12 timer, skal du omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: Thrombocytopenia, leucopenia, eosinophilia
Danish: Thrombocytopeni, leukopeni, eosinofili
English: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany
Danish: TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Tyskland
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Mylan and acetylsalicylic acid for this condition.
Danish: Du bør være blevet informeret om, at ”orale antikoagulantia” er mere effektive mod denne sygdom end acetylsalicylsyre eller kombinationen af Clopidogrel Mylan og acetylsalicylsyre.
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Danish: Dette var ensartet blandt undergrupperne af patienter defineret ved baseline karakteristika og typen af fibrinolytika eller heparinbehandling.
English: The most common side effect reported with Clopidogrel Mylan is bleeding.
Danish: Den almindeligste bivirkning, der er set med Clopidogrel Mylan, er blødning.
English: Driving and using machines Clopidogrel Mylan is unlikely to affect your ability to drive or to use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Clopidogrel Mylan påvirker din evne til at køre eller betjene maskiner.
English: By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).
Danish: Ved at forhindre denne sammenklumpning nedsætter en blodpropopløsende medicin risikoen for, at der dannes blodpropper (en proces, der kaldes trombose).
English: Sverige Mylan AB
Danish: Mylan AB
English: The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Danish: Sikkerheden og effekten af clopidogrel er blevet evalueret i 5 dobbeltblindede studier, der omfattede mere end 88.000 patienter: CAPRIE-studiet, hvor clopidogrel sammenlignes med ASA, og CURE, CLARITY, COMMIT- og ACTIVE-A-studierne, hvor clopidogrel sammenlignes med placebo, og hvor begge lægemidler gives i kombination med ASA eller anden standardterapi.
English: Clopidogrel has no or negligible influence on the ability to drive and use machines.
Danish: Clopidogrel påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: For the 7, 14, 28, 56, 84 tablets (calendar blister) pack sizes, you can check the day on which you last took a tablet of Clopidogrel Mylan by referring to the calendar printed on the blister
Danish: For pakninger med 7, 14, 28, 56 stk. og 84 stk. tabletter kan du kontrollere på hvilken dag du sidst tog en tablet ved at se på kalenderen, der er trykt på blisterpakningen.
English: signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions').
Danish: tegn på leverproblemer såsom gulfarvning af huden og/eller øjnene (gulsot), uanset om det sker i forbindelse med blødninger, som viser sig under huden som små røde prikker, og/eller forvirring (se afsnit 2 'Advarsler og forsigtighedsregler”).
English: Clopidogrel Mylan contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Danish: Clopidogrel Mylan indeholder clopidogrel og tilhører en lægemiddelgruppe, der kaldes blodfortyndende medicin.
English: In CURE, there was no excess in major bleeds with clopidogrel plus ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery.
Danish: I CURE var der ikke overrepræsentation af større blødninger med clopidogrel plus ASA inden for 7 dage efter koronar bypass hos patienter, der indstillede behandlingen mere end 5 dage før indgrebet.
English: In CHARISMA and one cohort study (Simon), an increased event rate was observed only in poor metabolisers when compared to extensive metabolisers.
Danish: I CHARISMA og et ken kohortestudie (Simon), sås kun en øget hyppighed af hændelser hos poor metabolisers i sammenligning med extensive metabolisers.
English: New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
Danish: Nye kardiovaskulære hændelser (primært endepunkt) blev forebygget med relative risikoreduktioner på 22 % (CI: 8,6,-33,4) 32 % (CI: 12,8,-46,4), 4 % (CI: -26,9,-26,7), 6 % (CI: -33,5,-34,3) og 14 % (CI: -31,6,-44,2), i løbet af studiets intervaller på henholdsvis 0-1, 1-3, 3-6, 6-9 og 9-12 måneder.
English: If you become pregnant while taking Clopidogrel Mylan, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Danish: Hvis du bliver gravid, mens du tager Clopidogrel Mylan, skal du omgående kontakte din læge, da det frarådes at tage clopidogrel under graviditet.
English: Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age 75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Danish: Patienter randomiseret i ACTIVE-programmet var dem, der blev præsenteret med dokumenteret AF, dvs. enten permanent AF eller mindst 2 episoder med intermitterende AF inden for de seneste 6 måneder, og som havde mindst én af følgende risikofaktorer: alder ≥ 75 år eller alder 55 til 74 år og enten behandlingskrævende diabetes mellitus eller dokumenteret tidligere MI eller dokumenteret koronararteriesygdom; behandlingskrævende systemisk hypertension; apopleksi, transitorisk cerebral iskæmi (TCI), eller non-CNS systemisk emboli i anamnesen; venstre ventrikel dysfunktion med venstre ventrikel uddrivningsfraktion <45 % eller dokumenteret perifer vaskulær sygdom.
English: As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Mylan.
Danish: Som forholdsregel bør amning ophøre under behandling med Clopidogrel Mylan.