FrancophonIA/ELRC3.0 huggingface dataset:
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel TAD.
Danish: Hvis du mener, at ovenstående gælder for dig, eller hvis du overhovedet er i tvivl, så rådfør dig med din læge, inden du tager Clopidogrel TAD.
English: If you become pregnant while taking Clopidogrel TAD, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Danish: Hvis du blivergravid, mens du tager Clopidogrel TAD, skal du omgående kontakte din læge, da det frarådes at tage Clopidogrel TAD under graviditet.
English: An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Danish: Lejlighedsvis brug af acetylsalicylsyre (højst 1000 mg i løbet af et døgn) skulle generelt ikke give problemer.
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 effects').
Danish: • skal du også fortælle det til din læge med det samme, hvis du 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 udtalt træthed, forvirring, gulning af huden eller øjnene (gulsot) (se afsnit 4 ”Bivirkninger”).
English: Cellulose, microcrystalline Colloidal anhydrous silica Crospovidone (type A) Macrogol 6000
Danish: Cellulose, mikrokrystallinsk Kolloidal vandfri silica Crospovidon (type A)
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel TAD in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Danish: Hvis du har haft alvorlige smerter i brystet (hjertekrampe (ustabil angina pectoris) eller hjerteanfald), kan din læge ordinere Clopidogrel TAD i kombination med acetylsalicylsyre, som er et stof, der indgår i mange typer medicin til smertelindring og febersænkning.
English: Do not stop the treatment unless your doctor tells you so.
Danish: Hvis du holder op med at tage Clopidogrel TAD Du må ikke stoppe behandlingen, medmindre din læge fortæller dig, at du skal gøre det.
English: You have been prescribed Clopidogrel TAD to help prevent blood clots and reduce the risk of these severe events because: - You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
Danish: Du har fået ordineret Clopidogrel TAD til forebyggelse af blodpropper og nedsættelse af risikoen for disse alvorlige hændelser, fordi: - Du lider af åreforkalkning (også kaldet aterosklerose) - og - Du tidligere har haft et hjerteanfald, apopleksi eller kredsløbsforstyrrelser i arme eller ben eller - Du har haft en alvorlig form for smerter i brystet, som kaldes hjertekrampe (ustabil angina pectoris) eller hjerteanfald (myokardieinfarkt).
English: Clopidogrel TAD is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Danish: Clopidogrel TAD tages af voksne for at forebygge dannelse af blodpropper (tromber) i blodårer (arterier), som er blevet stive ved en proces kaldet aterotrombose, hvilket kan føre til f.eks. apopleksi, hjerteanfald og død (aterotrombotiske hændelser).
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel TAD (4 tablets of 75 mg) once at the start of treatment.
Danish: Hvis du har haft alvorlige brystsmerter (ustabil angina pectoris eller hjertetilfælde), vil din læge måske indlede behandlingen med at give dig 300 mg Clopidogrel TADpå en gang (4 tabletter på 75 mg).
English: - If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
Danish: • hvis du har en aktiv blødning såsom et mavesår eller en blødning i hjernen;
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel TAD.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalettil råds, før du tager Clopidogrel TAD.
English: What Clopidogrel TAD contains - The active substance is clopidogrel.
Danish: Clopidogrel TAD indeholder: - Aktivt stof: clopidogrel.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 2 or section
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: If you forget to take Clopidogrel TAD
Danish: Hvis duhar glemt at tage Clopidogrel TAD
English: While you are taking Clopidogrel TAD: - You should tell your doctor if a surgery (including dental) is planned.
Danish: • skal du fortælle din læge, at du er i behandling med Clopidogrel TAD, hvis du skal have foretaget en planlagt operation (også hos tandlægen).
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: - oral anticoagulants, medicines used to reduce blood clotting, - a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, - heparin or any other injectable medicine used to reduce blood clotting, - ticlopidine, other antiplatelet agent, - a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,
Danish: Det er særlig vigtigt, at du fortæller det til din læge, hvis du tager: medicin, der kan øge risikoen for blødning, såsom: o blodfortyndende medicin, der tages gennem munden for at nedsætte dannelse af blodpropper, o en type smertestillende medicin (nonsteroide antiinflammatoriske lægemidler, NSAID'er), som normalt gives til behandling af smertefulde og/eller betændelseslignende tilstande i muskler eller led o heparin eller anden medicin til indsprøjtning for at nedsætte dannelse af blodpropper oticlopidin, der er anden medicin mod blodpropper o selektive serotoningenoptagelseshæmmere (inklusive, men ikke begrænset til fluoxetin og fluvoxamin), der normalt anvendes mod depression omeprazol eller esomeprazol til behandling af for meget mavesyre fluconazol eller voriconazol, der anvendes til behandling af svampeinfektioner efavirenz, der anvendes til behandling af HIV- (humant immundefektvirus) infektion carbamazepin der anvendes mod bestemte former for epilepsi moclobemid, medicin mod depression repaglinid, medicin til behandling af diabetes paclitaxel, medicin til behandling af kræft antiretrovirale lægemidler (hiv-medicin).
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: Ligesom andre antitrombotiske midler skal clopidogrel anvendes med forsigtighed til patienter med risiko for tiltagende blødninger pga. 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: What you need to know before you take Clopidogrel TAD
Danish: Det skal du vide, før du begynder at tage Clopidogrel TAD
English: The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel TAD per day to be taken orally with or without food, and at the same time each day.
Danish: Den anbefalede dosis, herunder også til patienter med ”atrieflimmer” (uregelmæssig hjerterytme), er 1 Clopidogrel TAD-tablet på 75 mg dagligt på samme tidspunkt hver dag.
English: Clopidogrel TAD 75 mg film-coated tablets clopidogrel
Danish: Clopidogrel TAD 75 mg filmovertrukne tabletter clopidogrel
English: There was an excess of intracranial bleeding in the clopidogrel + ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
Danish: Der var flere intrakranielle blødninger i clopidogrel + ASAgruppen sammenlignet med placebo + ASA-gruppen (1,4 % versus 0,8 %, henholdsvis).
English: Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45%
Danish: 80 mg omeprazol en gang daglig administreret enten samtidig med clopidogrel eller med 12 timers mellemrum nedsatte eksponeringen for den aktive metabolit med 45 % (ved initial mætningsdosis) og 40 % (vedligeholdelsesdosis).
English: Clopidogrel TAD 75 mg film-coated tablets
Danish: Clopidogrel TAD 75 mg filmovertrukne tabletter
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, aquired haemophilia A, granulocytopenia, anaemia
Danish: 4.4), aplastisk anæmi, pancytopeni, agranulocytose, alvorlig trombocytopeni, erhvervet hæmofili A, granulocytopeni, anæmi
English: - If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for clopidogrel eller et af de øvrige indholdsstoffer i Clopidogrel TAD
English: How to take Clopidogrel TAD
Danish: Sådan skal du tage Clopidogrel TAD
English: Clopidogrel was not shown to alter fertility in animal studies.
Danish: Fertilitet I dyreforsøg blev det ikke vist, at Clopidogrel ændrer fertiliteten.
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 TAD 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: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Danish: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Tyskland
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 (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
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,
English: Marketing Authorisation Holder TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Danish: Indehaver af markedsføringstilladelsen og fremstiller TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Tyskland
English: Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Danish: Glykoprotein IIb/IIIa-hæmmere: Clopidogrel skal anvendes med forsigtighed til patienter med øget risiko for blødninger pga. traumer, operation eller andre patologiske tilstande, hvor patienten samtidigt behandles med glykoprotein IIb/IIIa-hæmmere (se pkt.
English: What Clopidogrel TAD looks like and contents of the pack The film-coated tablets are pink, round and slightly convex.
Danish: De filmovertrukne tabletter er lyserøde, runde og let hvælvede.
English: What you need to know before you take Clopidogrel TAD 3.
Danish: Det skal du vide, før du begynder at tage Clopidogrel TAD Sådan skal du tage Clopidogrel TAD Bivirkninger
English: - a recent serious injury - a recent surgery (including dental) - a planned surgery (including dental) in the next seven days - if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days - if you have kidney or liver disease - if you have had an allergy or reaction to any medicine used to treat your disease.
Danish: • hvis du har risiko for blødninger som f.eks. på grund af: - en medicinsk lidelse, der medfører risiko for indre blødninger (så som 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 - et nyligt kirurgisk indgreb (gælder også tandoperationer) - et kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage
English: - If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: • kan det vare lidt længere end normalt, før blødningen stopper, hvis du skærer dig eller kommer til skade.
English: Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
Danish: - Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt i denne indlægsseddel.
English: CARTON
Danish: Hjerte
English: This point was not addressed in any of the trials.
Danish: Dette blev ikke berørt i nogen af undersøgelserne.
English: In order to minimise these risks several measures were proposed.
Danish: For at minimere disse risici blev der foreslået flere foranstaltninger.
English: Safety issues
Danish: Sikkerhedsspørgsmål
English: In addition, the missing data and their handling were considered problematic from a statistical point of view.
Danish: Desuden blev manglende data og håndtering deraf anset for problematiske fra et statistisk synspunkt.
English: Additional risk minimisation measures within a Risk management Plan were not considered necessary.
Danish: Yderligere risikominimeringsforanstaltninger inden for rammerne af en risikostyringsplan ansås ikke for nødvendigt.
English: Overall summary of the scientific evaluation of diacerein containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder diacerein (se bilag I)
English: • The PRAC considered that several new measures should be implemented to minimise these risks.
Danish: • PRAC fandt, at der burde gennemføres flere nye foranstaltninger til minimering af disse risici.
English: There is no consensus on the role of SYSADOA in the pharmacological treatment of OA.
Danish: Der er ikke konsensus om rollen af SYSADOA i medikamentel behandling af OA.
English: In addition, the management of diarrhoea could also expose patients to symptomatic treatments.
Danish: Desuden kunne også behandlingen af diarré udsætte patienterne for symptomgivende behandling.
English: The agreed new data lock point (DLP) of 31 December 2014 for all diacerein-containing medicinal products will be reflected in the list of Union reference dates (EURD list).
Danish: Det aftalte nye dataafskæringspunkt, den 31. december 2014, for alle lægemidler indeholdende diacerein vil blive afspejlet i listen over EU-referencedatoer (EURD-listen).
English: However, it was acknowledged that a sparing effect on paracetamol use had been demonstrated in four out of eight clinical trials.
Danish: Det vedgås dog, at der blev påvist besparende virkning på brug af paracetamol i fire ud af otte kliniske undersøgelser.
English: Patients should be advised to limit their alcohol intake while on treatment with diacerein.
Danish: Patienterne burde tilrådes at begrænse deres alkoholindtagelse under behandlingen med diacerein.
English: It was also noted that in the majority of cases diacerein-induced diarrhoea started soon after treatment initiation, and seemed to be reversible after cessation of treatment.
Danish: Det bemærkedes desuden, at diarré fremkaldt af diacerein i de fleste tilfælde begyndte straks efter påbegyndelse af behandlingen og syntes at være reversibel efter ophør af behandlingen.
English: Overall, studies showed a modest but statistically significant effect on pain and physical functioning.
Danish: Alt i alt har undersøgelserne vist en beskeden, men statistisk signifikant virkning på smerter og fysisk funktion.
English: Diacerein and its active metabolite, rhein, are anthranquinone derivates.
Danish: Diacerein og dets aktive metabolit, rhein, er derivater af anthraquinon.
English: Following the adoption of the PRAC recommendation during the November 2013 PRAC meeting, two MAHs expressed their disagreement with the initial recommendation for suspension.
Danish: Efter vedtagelse af PRAC's anbefaling på PRAC's møde i november 2013 udtrykte to markedsføringstilladelsesindehavere sig uenige i den første anbefaling om suspendering.
English: Most of transient diarrhoea are reported in the first 2 to 4 weeks and the laxative properties of diacerein seem to be dose-dependent.
Danish: De fleste tilfælde af forbigående diarré indberettes i de første 2-4 uger, og diacereins laksative egenskaber synes at være dosisafhængige.
English: In addition, in both cases the study authors reported no difference between groups on analgesic consumption.
Danish: Endvidere beskrev ingen af forfatterne til de to undersøgelser forskel mellem analgetikaforbruget i grupperne.
English: However, the quality of the studies was heterogeneous and publication bias could not be excluded since only published trials and nonpublished trials sponsored by the companies were included in the systematic reviews.
Danish: Undersøgelsernes kvalitet var imidlertid uensartet, og der kunne ikke udelukkes publikationsbias, da de systematiske oversigter kun omfattede publicerede undersøgelser og ikke-publicerede undersøgelser sponsoreret af virksomhederne.
English: It is acknowledged that OA of the hip and knee is seen more frequently in an elderly population.
Danish: Det anerkendes, at osteoartritis i hofte og knæ forekommer hyppigere hos den ældre population.
English: In spontaneous reports, one quarter of serious gastrointestinal cases were related with diarrhoea.
Danish: I spontane indberetninger var en fjerdedel af alvorlige gastrointestinale tilfælde forbundet med diarré.
English: Even though its mechanism of action is not completely known, it differs from non-steroidal anti-inflammatory drugs (NSAIDs) as it does not inhibit prostaglandin synthesis nor affect its levels.
Danish: Skønt dets virkningsmekanisme ikke kendes fuldstændigt, afviger det fra nonsteroide antiinflammatoriske lægemidler (NSAID) ved ikke at hæmme syntesen af prostaglandin eller påvirke dets koncentration.
English: About 10% of adverse drug reactions (ADR) reported were hepatic disorders and in over 68% of these cases, diacerein was the only drug suspected.
Danish: Ca. 10 % af de indberettede bivirkninger var leverlidelser, og i over 68 % af disse tilfælde var diacerein det eneste mistænkte lægemiddel.
English: This constituted a concern for the PRAC and it has to be noted that these investigations exposed the patients to invasive examination (i.e. colonoscopy with biopsy).
Danish: Dette fandt PRAC betænkeligt, og det må bemærkes, at disse undersøgelser udsatte patienterne for en invasiv diagnostisk procedure (koloskopi med biopsi).
English: It is thought that diacerein works by blocking/reducing the actions of interleukin-1β, a protein involved in the process of articular cartilage destruction and synovial inflammation (Yaron M et al., 1999; Alvarez Soria et al., 2008; Legendre F et al., 2009).
Danish: Diacerein menes at virke ved at blokere/reducere virkningerne af proteinet interleukin-1β, der medvirker ved nedbrydningen af ledbrusk og den synoviale inflammation (Yaron M. et al., 1999; Alvarez Soria et al., 2008 og Legendre F. et al., 2009).
English: Moreover, two cases raised serious concerns: one fatal hepatitis case in which no other reasons of hepatitis except for diacerein could be found; and one case of acute hepatitis with suggestive chronology and no other explanation.
Danish: Desuden gav to tilfælde anledning til alvorlige betænkeligheder: ét ikke-fatalt tilfælde af hepatitis, i hvilket der ikke kunne findes anden årsag til hepatitis end diacerein, og ét tilfælde af akut hepatitis med påfaldende tidsmæssig sammenhæng og uden anden forklaring.
English: Because of the limited information available on these cases, the PRAC could not conclude on this risk but a cutaneous toxicity of diacerein could not be excluded.
Danish: På grund af de begrænsede foreliggende oplysninger om disse tilfælde kunne PRAC ikke drage konklusioner om risikoen, men kutan toksicitet af diacerein kunne ikke udelukkes.
English: The main studies evaluating structural progression or disease modifying properties in OA ((i) Echodiah study (Dougados et al. 2001) with 255 patients in the diacerein arm and 252 under placebo for three years of treatment; and (ii) Pham study (2004) which included 85 patients in the diacerein arm and 85 under placebo during one year) did not show convincing evidence of efficacy of diacerein on pain or physical functioning.
Danish: Hovedundersøgelserne til vurdering af virkningen på strukturel sygdomsprogression eller sygdomsmodificerende virkning ved osteoartritis ((i) Echodiah-undersøgelsen (Dougados et al. 2001), der omfattede 255 patienter i diacerein-armen og 252 med placebo behandlet i tre år, og (ii) Phamundersøgelsen (2004), der omfattede 85 patienter i diacerein armen og 85 på placebo i et år) gav ikke overbevisende evidens for virkning af diacerein på smerter eller fysisk funktion.
English: Some studies revealed that 25% patients with diarrhoea during diacerein treatment experienced chronic diarrhoeas, defined by diarrhoea persisting more than 4 weeks.
Danish: Nogle undersøgelser viste, at 25 % af patienter i behandling med diacerein fik kronisk diarré, defineret som diarré af mere end 4 ugers varighed.
English: The effects of diacerein on pain and physical functioning of the joints have been evaluated in a number of studies as primary endpoints.
Danish: Virkningerne af diacerein på smerter og fysisk funktion af leddene er blevet vurderet i en række undersøgelser som primære endepunkter.
English: A reduction in the use of NSAID was only shown in one study and therefore a sparing effect of diacerein on NSAIDs could not be confirmed.
Danish: Reduktion af brugen af NSAID blev kun påvist i den ene undersøgelse, hvorfor en NSAID-besparende virkning af diacerein ikke kunne bekræftes.
English: With regards to the risk of gastrointestinal disorders, diarrhoea was a common and expected reaction of diacerein.
Danish: Hvad angår risiko for gastrointestinale lidelser var diarré en almindelig og forventelig reaktion på diacerein.
English: Double blind placebo controlled clinical trials performed during the last 20 years showed heterogeneous results, which may be explained by the usual high placebo effect in this kind of indications.
Danish: Dobbeltblindede, placebokontrollerede kliniske undersøgelser gennem de sidste tyve år har vist forskellige resultater, hvilket kan forklares ved den usædvanligt store placeboeffekt ved denne type indikationer.