FrancophonIA/ELRC3.0 huggingface dataset:
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, calcium antagonister, kolesterolsænkende midler, dilatatorer med effekt på koronarkarrene, antidiabetika(inklusive insulin), antiepileptika samt GPIIb/IIIa-hæmmere, uden at der blev påvist klinisk signifikante uønskede interaktioner.
English: -Rare side effect (may affect up to 1 in 1,000 people): Vertigo, enlarged breasts in males.
Danish: - Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 patienter): Svimmelhed (fornemmelse af at snurre rundt), forstørrede bryster hos mænd.
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel ratiopharm GmbH.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager Clopidogrel ratiopharm GmbH.
English: If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
Danish: • hvis De har en aktiv blødning såsom et mavesår eller en blødning i hjernen.
English: 43 patients (13.4%) in the de-escalated DAPT group and in 85 patients (26.3%) in the unchanged DAPT group (p<0.01).
Danish: (13,4 %) i de-eskaleret DAPT-gruppen og hos 85 patienter (26,3 %) i den uændrede DAPT-gruppe (p <0,01).
English: The primary outcome, a composite of cardiovascular death, stroke, urgent revascularization, and
Danish: Det primære resultat sammensat af kardiovaskulær død, slagtilfælde, akut revaskularisering og BARC
English: If you have any further questions, ask your doctor or your pharmacist.
Danish: Er De i tvivl, så spørg lægen eller apotekspersonalet.
English: If you become pregnant while taking Clopidogrel ratiopharm GmbH, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Danish: Hvis De bliver gravid, mens De tager Clopidogrel ratiopharm GmbH, skal De omgående kontakte Deres læge, da det frarådes at tage Clopidogrel ratiopharm GmbH under graviditet.
English: Then, the recommended dose is one 75 mg tablet of Clopidogrel ratiopharm GmbH per day to be taken orally with or without food, and at the same time each day.
Danish: Derefter er den anbefalede dosis 1 Clopidogrel ratiopharm GmbH-tablet på 75 mg dagligt, som indtages gennem munden alene eller i forbindelse med et måltid.
English: EU/1/09/541/001 - Cartons of 14 film-coated tablets in Alu/Alu blisters EU/1/09/541/002 - Cartons of 28 film-coated tablets in Alu/Alu blisters EU/1/09/541/003 - Cartons of 30 film-coated tablets in Alu/Alu blisters EU/1/09/541/004 - Cartons of 50 film-coated tablets in Alu/Alu blisters EU/1/09/541/005 - Cartons of 84 film-coated tablets in Alu/Alu blisters EU/1/09/541/006 - Cartons of 90 film-coated tablets in Alu/Alu blisters EU/1/09/541/007 - Cartons of 100 film-coated tablets in Alu/Alu blisters EU/1/09/541/008 - Cartons of 7 film-coated tablets in Alu/Alu blisters
Danish: EU/1/09/541/003 - Pakning med 30 filmovertrukne tabletter i blisterkort af aluminium EU/1/09/541/004 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af aluminium EU/1/09/541/005 - Pakning med 84 filmovertrukne tabletter i blisterkort af aluminium EU/1/09/541/006 - Pakning med 90 filmovertrukne tabletter i blisterkort af aluminium EU/1/09/541/007 - Pakning med 100 filmovertrukne tabletter i blisterkort af aluminium EU/1/09/541/008 - Pakning med 7 filmovertrukne tabletter i blisterkort af aluminium
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 (NSAID'er) inklusive cox-2 hæmmere eller selektive serotoningenoptagelseshæmmere (SSRI'er), eller andre lægemidler forbundet med risiko for blødning, såsom pentoxifyllin (se pkt.
English: If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for clopidogrel eller et af de øvrige indholdsstoffer i Clopidogrel ratiopharm GmbH (angivet i afsnit 6).
English: If you experience prolonged bleeding when taking Clopidogrel ratiopharm GmbH.
Danish: Hvis De får langvarige blødninger, mens De tager Clopidogrel ratiopharm GmbH.
English: Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Danish: Hver filmovertrukket tablet indeholder 75 mg af clopidogrel (som besilat).
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N = 6,259) or placebo (N = 6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
Danish: Patienterne blev randomiseret til clopidogrel (300 mg initial mætningsdosis efterfulgt af 75 mg/dag, N=6.259) eller placebo (N=6.303), begge i kombination med ASA (75-325 mg en gang daglig) samt anden standardbehandling.
English: Package leaflet: Information for the user Clopidogrel ratiopharm GmbH 75 mg film-coated tablets clopidogrel
Danish: Indlægsseddel: Information til brugeren Clopidogrel ratiopharm GmbH 75 mg filmovertrukne tabletter clopidogrel
English: Talk to your doctor or pharmacist before taking Clopidogrel ratiopharm GmbH: if you have a risk of bleeding such as a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body) 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 De har risiko for blødninger f.eks. på grund af: en medicinsk lidelse, der medfører risiko for indre blødninger (såsom et mavesår) en blødningslidelse, der giver Dem 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 planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage
English: (alone or in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician.
Danish: Patienter i behandling med clopidogrel (alene eller i kombination med ASA) bør informeres om, at det kan tage længere tid end normalt at standse blødninger, samt at de bør kontakte deres læge ved enhver usædvanlig blødning (sted eller varighed).
English: Clopidogrel ratiopharm GmbH with food and drink
Danish: Brug af Clopidogrel ratiopharm GmbH sammen med mad og drikke
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: Dette kan ske på grund af et sjældent fald i visse blodlegemer - 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 forsigthedsregler') - hævelser i munden eller hudproblemer såsom udslæt og kløe, blærer på huden.
English: Clopidogrel ratiopharm GmbH contains hydrogenated castor oil
Danish: Clopidogrel ratiopharm GmbH indeholder hydrogeneret ricinusolie
English: The guided de-escalation did not result in an increased combined risk of ischemic events (2.5% in the deescalation group vs 3.2% in the control group; p non-inferiority=0.0115), nor in the key secondary endpoint of BARC bleeding ≥2 ((5%) in the de-escalation group versus 6% in the control group (p=0.23)).
Danish: Den guidede de-eskalering resulterede ikke i en øget kombineret risiko for iskæmiske hændelser (2,5 % i de-eskaleringsgruppen mod 3,2 % i kontrolgruppen, p non-inferioritet = 0,0115),
English: Medicinal products that are strong or moderate CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz.
Danish: fluvoxamin, fluoxetin, moclobemid, voriconazol, fluconazol, ticlopidin, carbamazepin og efavirenz.
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints o heparin or any other injectable medicine used to reduce blood clotting o ticlopidine, other antiplatelet agent, o 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
Danish: 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 o ticlopidin, der er anden medicin mod blodpropper o selektive serotoningenoptagelseshæmmere (herunder, 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 - antiretrovirale lægemidler (hiv-medicin) - carbamazepin, der anvendes mod bestemte former for epilepsi - moclobemid, medicin mod depression.
English: Contents of the pack and other information What Clopidogrel ratiopharm GmbH contains
Danish: PAKNINGSSTØRRELSER OG YDERLIGERE OPLYSNINGER Clopidogrel ratiopharm GmbH indeholder:
English: ST segment elevation acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300 mg loading dose in combination with ASA and with or without thrombolytics.
Danish: - akut myokardieinfarkt med elevation af ST-segmentet: Behandling med clopidogrel bør bestå af en daglig dosering på 75 mg, indledt med en mætningsdosis på 300 mg i kombination med ASA
English: Gynaecomastia
Danish: Ricinusolie
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Danish: Antallet af patienter, som oplevede det primære endepunkt [kardiovaskulært dødsfald, myokardieinfarkt, apopleksi eller refraktær iskæmi] var 1.035 (16,5 %) i clopidogrelgruppen og 1.187 (18,8 %) i placebogruppen, hvilket giver en relativ risikoreduktion på 14 % (95 % CI: 6 %-21 %;
English: If you forget to take Clopidogrel ratiopharm GmbH
Danish: Hvis De har glemt at tage Clopidogrel ratiopharm GmbH
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 July 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: While you are taking Clopidogrel ratiopharm GmbH:
Danish: Mens De er i behandling med Clopidogrel ratiopharm GmbH:
English: What you need to know before you take Clopidogrel ratiopharm GmbH Do not take Clopidogrel ratiopharm GmbH
Danish: Det skal De vide, før De begynder at tage Clopidogrel ratiopharm GmbH Sådan skal De tage Clopidogrel ratiopharm GmbH Bivirkninger
English: The other ingredients are (see section 2 ‘Clopidogrel ratiopharm GmbH contains hydrogenated castor oil'):
Danish: 2 ”Clopidogrel ratiopharm GmbH indeholder hydrogeneret ricinusolie”):
English: Clopidogrel ratiopharm GmbH 75 mg film-coated tablets clopidogrel
Danish: Clopidogrel ratiopharm GmbH 75 mg filmovertrukne tabletter clopidogrel
English: Clopidogrel ratiopharm GmbH 75 mg film-coated tablets
Danish: Clopidogrel ratiopharm GmbH 75 mg filmovertrukne tabletter
English: You should tell your doctor if a surgery (including dental) is planned.
Danish: • Skal De fortælle Deres læge, at De er i behandling med Clopidogrel ratiopharm GmbH hvis De skal have foretaget en planlagt operation (også hos tandlægen),.
English: Contact your doctor or pharmacist before stopping.
Danish: Kontakt Deres læge eller apoteket, før De holder op. Spørg lægen eller apotekspersonalet, hvis der er noget, De er i tvivl om.
English: 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 (disturbed blood flow in arms or legs caused by vascular occlusions) or
Danish: De har fået recept på Clopidogrel ratiopharm GmbH til forebyggelse af blodpropper og nedsættelse af risikoen for disse alvorlige hændelser, fordi: - De lider af åreforkalkning (også kaldet aterosklerose) - og - De tidligere har haft et hjerteanfald, apopleksi eller en tilstand kaldet perifer arteriel sygdom (kredsløbsforstyrrelser i arme eller ben, forårsaget af vaskulær okklusion), eller - De har haft en alvorlig form for smerter i brystet, som kaldes hjertekrampe (ustabil angina pectoris) eller hjerteanfald (myokardieinfarkt).
English: Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information related to clopidogrel with frequency “not known”
Danish: * Information relateret til clopidogrel med hyppighed ”ikke kendt”.
English: How to take Clopidogrel ratiopharm GmbH
Danish: SÅDAN SKAL DE TAGE CLOPIDOGREL RATIOPHARM GMBH
English: Other medicines and Clopidogrel ratiopharm GmbH
Danish: Brug af anden medicin sammen med Clopidogrel ratiopharm GmbH:
English: 1121 Vienna
Danish: 1121 Wien
English: Date of first authorisation: 13 April 1999 Date of latest renewal: 25 March 2009
Danish: Dato for første markedsføringstilladelse: 13. april 1999 Dato for seneste fornyelse: 25. marts 2009
English: This can be clarified by an arteriogram.
Danish: Dette kan afklares ved hjælp af et arteriogram.
English: The changes observed at the low dose of the 13-week studies can be classified as minimal and fully reversible.
Danish: De observerede ændringer ved den lave dosis i 13-ugers studierne kan klassificeres som minimale og fuldt ud reversible.
English: Therefore patients should be monitored during the first three days after the ILP.
Danish: Derfor bør patienter monitoreres i de første tre dage efter ILP.
English: However, the treatment is specifically a loco-regional treatment and is not expected to influence survival.
Danish: Behandlingen er dog en specifik lokalregional behandling og forventes ikke at påvirke overlevelsen.
English: The following side effects were observed during treatment with this medicine (grouped by how likely they are to happen).
Danish: Følgende bivirkninger blev observeret under behandlingen med denne medicin (grupperet efter hvor sandsynlige de er).
English: The formulation does not contain a preservative and is for single use only.
Danish: Formuleringen indeholder ikke konserveringsmiddel og er til engangsbrug.
English: You must not use Beromun if you are pregnant.
Danish: Du må ikke få Beromun, hvis du er gravid.
English: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000
Danish: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000).
English: The powder is white to off-white.
Danish: Pulveret er hvidt til offwhite.
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2 °C -8 °C).
English: Severe ascites.
Danish: Alvorlig ascites.
English: Induction of general anaesthesia and subsequent mechanical ventilation should be applied according to standard methods.
Danish: Induktion af generel anæstesi og efterfølgende mekanisk ventilation skal foretages i henhold til standardmetoderne.
English: Treatment with anti-TNFα antibodies is not recommended.
Danish: Behandling med anti-TNFα immunstoffer anbefales ikke.
English: Once opened, the content of a vial should normally be used immediately (see section 6.3).
Danish: Efter åbning skal beholderens indhold normalt anvendes straks (se afsnit 6.3.).
English: For the prophylaxis of shock, patients should always be maximally hydrated prior to, during and after the perfusion procedure.
Danish: Som shockprofylakse bør patienterne altid hydreres maksimalt før, under og efter perfusionsproceduren.
English: Beromun must not be administered systemically.
Danish: Beromun må ikke administreres systemisk.
English: It is not known whether tasonermin is excreted in human milk.
Danish: Det er ukendt, om tasonermin udskilles i human mælk.
English: There are no adequate data from the use of tasonermin in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af tasonermin til gravide kvinder.
English: Some of the side effects can be serious, particularly if Beromun reaches other parts of your body (systemic leakage).
Danish: Nogle af bivirkningerne kan være alvorlige, især hvis Beromun når ud i andre dele af kroppen (systemisk lækage).
English: SN: {number} [serial number]
Danish: PC: {nummer} SN: {nummer} NN: {nummer}
English: Adult respiratory distress syndrome
Danish: Adult respiratory distress syndrom
English: The solution of the reconstituted product should be inspected visually for particulate matter prior to administration.
Danish: Opløsningen af det rekonstruerede produkt bør inspiceres visuelt for partikler før administration.
English: A second specific and saturable elimination mechanism involving tasonermin receptors seems likely.
Danish: En anden specifik og mættet elimineringsmekanisme som involverer tasonermin receptorerne synes at være sandsynlig.
English: No evidence has been found of any mutagenic effect, neither in vivo nor in vitro.
Danish: Der er ikke blevet fundet evidens for nogen mutagen virkning, hverken in vivo eller in vitro.
English: No NOTEL (No Observed Toxic Effect Level) could be established in the preclinical studies with the exception of a 7-day administration of 0.1 µg/kg in monkeys.
Danish: Ingen NOTEL (No Observed Toxic Effect Level) kunne bestemmes i de prækliniske studier med undtagelse af en 7-dages administration af 0,1 µg/kg i aber.
English: Systemic adverse reactions include mild constitutional reactions and toxic effects on different organ systems.
Danish: Systemiske bivirkninger inkluderer lette konstitutionelle reaktioner og toksiske effekter på forskellige organsystemer.
English: The temperature should then be increased to >39°C (but not exceeding 40°C) in two different sites of measurement in the tumour area.
Danish: Temperaturen skal herefter øges til >39 °C (men må ikke overstige 40 °C) målt på 2 forskellige steder i tumorområdet.
English: You must not breast-feed for at least seven days after treatment with Beromun.
Danish: Du må ikke amme i mindst 7 dage efter behandling med Beromun.
English: 2, Rue Albert 1er L-1117 Luxembourg Grand Duchy of Luxembourg Tel : +352 27403070
Danish: 2, Rue Albert 1er L-1117 Luxembourg Storhertugdømmet Luxembourg Tel : +352 27403070
English: Upon reconstitution the product should be used immediately.
Danish: Efter rekonstitution skal produktet bruges med det samme.
English: Additional resuscitation fluids (crystalloid and colloid solutions) should be available for volume expansion in case of a significant fall in blood pressure.
Danish: Supplerende genoplivningsvæsker (krystalloid- og kolloidopløsninger) bør være til rådighed til volumenudvidelse i tilfælde af et væsentligt fald i blodtrykket.
English: Pharmacotherapeutic group: Other immunostimulants, ATC code: L03AX11
Danish: Farmakoterapeutisk klassifikation: Andre immunstimulanter, ATC-kode: L03AX11
English: The perfusion should be terminated if the cumulative leakage into the systemic circulation is > 10%.
Danish: Perfusionen bør afbrydes hvis den kumulative lækage til den systemiske cirkulation er >10 %.
English: The systemic pharmacokinetic information on tasonermin is sparse.
Danish: Den systemiske farmakokinetiske information om tasonermin er sparsom.
English: The reason for the differential sensitivity of the tumour vasculature (high) versus normal vasculature (low) are currently unknown.
Danish: Årsagen til forskellig sensitivitet af tumorvaskulariseringen (høj) i forhold til normal vaskularisering (lav) er for øjeblikket ukendt.
English: The safety and efficacy of Beromun in children under 18 years have not been established.
Danish: Pædiatrisk population Beromuns sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: A condition called “compartment syndrome” may develop within the first three days after Beromun administration.
Danish: En lidelse, der hedder ”kompartment-syndrom” kan udvikle sig inden for de tre første dage efter indgift af Beromun.
English: For any information about this medicine, please contact the Marketing Authorisation Holder:
Danish: Med hensyn til yderligere oplysninger om dette lægemiddel bedes man rette henvendelse til indehaveren af markedsføringstilladelsen:
English: Hypercalcaemia > 12 mg/dl (2.99 mmol/l).
Danish: Hypercalcæmi > 12 mg/dl (2,99 mmol/l).
English: Contraindications to the ILP procedure:
Danish: Kontraindikationer for ILP-proceduren:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke bruges straks, er ansvaret for ”i-brug” opbevaringsbetingelserne og -tiden brugerens ansvar og bør normalt ikke være af længere varighed end 24 timer ved 2-8 °C, medmindre rekonstitution er blevet foretaget under kontrollerede og aseptisk validerede omgivelser.
English: There is no specific antidote for tasonermin currently available.
Danish: Der findes p.t. ingen tilgængelig specifik antidot for tasonermin.
English: Further, animals that reject experimental tumours following tasonermin treatment may develop specific immunity for this tumour cell type.
Danish: Desuden kan dyr, som har afstødt eksperimentelle tumorer efter tasonermin behandling, udvikle specifik immunitet over for denne type tumorceller.
English: There is no evidence that any of these agents counteracts the pharmacodynamic effects of tasonermin.
Danish: Der er ingen evidens for, at nogen af disse midler modvirker de farmakodynamiske virkninger af tasonermin.
English: As Beromun is always administered by experienced and qualified hospital doctors, accidental overdose is extremely unlikely.
Danish: Da Beromun altid administreres af erfarne og kvalificerede hospitalslæger, er overdosering som følge af uheld uhyre sjælden.
English: If there is significant systemic leakage of Beromun
Danish: Hvis der sker en betydningsfuld systemisk lækage af Beromun