FrancophonIA/ELRC3.0 huggingface dataset:
English: You have been prescribed Zyllt 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 Zyllt 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: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter (f.eks. lactose), skal du kontakte lægen, før du tager dette lægemiddel.
English: Zyllt 75 mg film-coated tablets clopidogrel
Danish: Zyllt 75 mg filmovertrukne tabletter clopidogrel
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, antidiabetika (inklusive insulin), antiepileptika samt GPIIb/IIIa-hæmmere, uden at der blev påvist klinisk signifikante uønskede interaktioner.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose-/galactosemalabsorption.
English: Zyllt 75 mg film-coated tablets
Danish: Zyllt 75 mg filmovertrukne tabletter
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: Clopidogrel bør administreres som en enkelt daglig dosis på 75 mg, indledt med en mætningsdosis på 300 mg i kombination med ASA og med eller uden trombolytika.
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: 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 oheparin eller anden medicin til indsprøjtning for at nedsætte dannelse af blodpropper o ticlopidin, 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: Zyllt contains lactose
Danish: Zyllt indeholder lactose
English: The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Zyllt 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 Zyllt-tablet på 75 mg dagligtpå samme tidspunkt hver dag.
English: Zyllt contains lactose.
Danish: Zyllt indeholder lactose.
English: What you need to know before you take Zyllt
Danish: Det skal du vide, før du begynder at tage Zyllt
English: It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever.
Danish: Det er karakteriseret ved trombocytopeni og mikroangiopatisk hæmolytisk anæmi i forbindelse med enten neurologiske fund,
English: Very rare side effects (may affect up to 1 in 10,000 people): jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of food.
Danish: Gulsot; alvorlige mavesmerter med eller uden rygsmerter; feber, åndedrætsbesvær ind imellem i ledsaget af hoste; generelle allergiske reaktioner (f.eks. varmefølelse over hele kroppen med pludselig almen utilpashed og eventuel besvimelse); hævelse i munden; blister på huden; allergi på huden; ømhed i munden (stomatitis); blodtryksfald; forvirring; hallucinationer; ledsmerter;
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Danish: I intention-to-treat-analysen blev der observeret 939 tilfælde i clopidogrelgruppen og 1.020 tilfælde i ASA-gruppen (relativ risikoreduktion (RRR) 8,7 % [95 % CI: 0,2-16,4], p=0,045), hvilket for hver 1000 patienter, der blev behandlet i 2 år, svarer til, at yderligere 10 [CI: 0-20] patienter beskyttes mod et nyt iskæmisk tilfælde.
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: There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Danish: Der der dog foretaget et antal retrospektive analyser for at evaluere denne effekt hos patienter i behandling med clopidogrel, for hvem der foreligger resultater af genotyping: CURE (n=2.721), CHARISMA (n=2.428), CLARITY
English: In patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Danish: Hos patienter med akut koronarsyndrom - Ved akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina pectoris eller myokardieinfarkt uden forekomst af Q-takker) bør behandling med clopidogrel indledes med en enkelt initial mætningsdosis på 300 mg og derefter fortsættes med 75 mg én gang dagligt
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Zyllt (4 tablets of 75 mg) once at the start of treatment.
Danish: Hvis duhar haft alvorlige brystsmerter (ustabil angina pectoris eller hjertetilfælde), vil din læge måske indlede behandlingen med at give dig300mgZyllt (4 tabletterpå75mg) én gang.
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-2
English: What Zyllt 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: The number of patients who reached the primary endpoint (time to first occurrence of stroke, MI, non-CNS systemic embolism or vascular death) was 832 (22.1%) in the group treated with clopidogrel + ASA and 924 (24.4%) in the placebo + ASA group (relative risk reduction of 11.1%; 95% CI of 2.4% to 19.1%; p=0.013), primarily due to a large reduction in the incidence of strokes.
Danish: Antallet af patienter, der nåede det primære endepunkt (tid til første forekomst af apopleksi, MI, nonCNS systemisk emboli eller vaskulær død) var 832 (22,1 %) i gruppen behandlet med clopidogrel + ASA og 924 (24,4 %) i placebo + ASA-gruppen (relativ risikoreduktion 11,1 %; 95% CI 2,4 % til 19,1 %, p = 0,013).
English: Reproductive systems and breast disorders
Danish: Det reproduktive system og
English: • 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).
Danish: • hvis du 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 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 planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage
English: • Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Danish: Hvis en dosis glemmes: - Mindre end 12 timer efter planlagt administration: patienten skal straks tage den glemte dosis og tage den næste dosis som planlagt.
English: • Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Danish: - Nedsat nyrefunktion Der er kun begrænset erfaring med behandling af patienter med nedsat nyrefunktion (se pkt.
English: Kipa Pharmacal Ltd. Τηλ: + 357 24 651 882
Danish: Τηλ: + 357 24 651 882
English: How to take Zyllt
Danish: Sådan skal du tage Zyllt
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Danish: Antallet af patienter, som oplevede det primære endepunkt [kardiovaskulært dødsfald, myokardieinfarkt eller apopleksi] var 582 (9,3 %) i clopidogrelgruppen og 719 (11,4 %) i placebogruppen, hvilket giver en relativ risikoreduktion på 20 % (95 % CI: 10 %-28 %; p=0,00009) for clopidogrelgruppen (en relativ risikoreduktion på 17 %, når patienterne fik konservativ behandling,
English: Rare side effects (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 patienter):
English: KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE)
Danish: Tel: + 46 (0)8 643 67 66 (SE)
English: What you need to know before you take Zyllt 3.
Danish: Virkning og anvendelse Det skal du vide, før du begynder at tage Zyllt Sådan skal du tage Zyllt Bivirkninger
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Zyllt til dig personligt.
English: What Zyllt contains - The active substance is clopidogrel.
Danish: Zyllt 75 mg filmovertrukne tabletter indeholder: - Aktivt stof: clopidogrel.
English: - If you have any further questions, ask your doctor or your pharmacist.
Danish: Er dui tvivl, såspørg lægen eller apotekspersonalet.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sustiva on 28 May 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sustiva den 28. maj 1999.
English: The recommended dose of Sustiva for adults is 600 mg once a day.
Danish: Den anbefalede dosis af Sustiva til voksne er 600 mg én gang dagligt.
English: The full EPAR for Sustiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Sustiva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In patients aged 3 months to 17 years, the dose depends on body weight.
Danish: Hos patienter i alderen tre måneder til 17 år afhænger dosis af kropsvægten.
English: This is a summary of the European public assessment report (EPAR) for Sustiva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sustiva.
English: Other information about Sustiva
Danish: Andre oplysninger om Sustiva
English: It is not intended to provide practical advice on how to use Sustiva.
Danish: Det er ikke en praktisk vejledning i, hvordan Sustiva bør anvendes.
English: What is Sustiva and what is it used for?
Danish: Hvad er Sustiva, og hvad anvendes det til?
English: The active substance in Sustiva, efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Danish: Det aktive stof i Sustiva, efavirenz, er en non-nukleosid revers transkriptase-hæmmer (NNRTI).
English: Sustiva must be avoided if patients are taking certain medicines because it can increase their side effects or reduce their effectiveness, or because the combination may increase effects on the heart.
Danish: Sustiva skal undgås, hvis patienterne tager visse lægemidler, da det kan øge bivirkningerne ved dem eller mindske deres virkning, eller fordi kombinationen kan øge indvirkningen på hjertet.
English: It is available as capsules and tablets and must be given in combination with other antiviral medicines.
Danish: Det fås som kapsler og tabletter og skal gives i kombination med andre antivirale lægemidler.
English: The dose of Sustiva may need to be adjusted in patients taking certain other medicines at the same time.
Danish: Det kan være nødvendigt at tilpasse dosis af Sustiva hos patienter, der samtidig får visse andre lægemidler.
English: Similar results have been seen in studies involving 182 patients (of whom 177 were children aged between 3 months and 18 years) in combination with nelfinavir and other antiviral medicines.
Danish: Der er observeret lignende resultater i undersøgelser af 182 patienter (hvoraf 177 var børn i alderen tre måneder til 18 år) i kombination med nelfinavir og andre antivirale lægemidler.
English: Similarly, it must not be used in patients with altered levels of salts (electrolytes) such as potassium or magnesium in their blood.
Danish: Det må heller ikke anvendes hos patienter med ændrede salt-niveauer (elektrolytter) som f.eks. kalium eller magnesium i deres blod.
English: What measures are being taken to ensure the safe and effective use of Sustiva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sustiva?
English: Why is Sustiva approved?
Danish: Hvorfor blev Sustiva godkendt?
English: It is recommended that Sustiva be taken on an empty stomach and without food, preferably at bedtime.
Danish: Det anbefales, at Sustiva tages på tom mave og uden samtidig fødeindtagelse, fortrinsvis ved sengetid.
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Danish: Det blokerer aktiviteten af revers transkriptase, et enzym, som hiv-virussen producerer, så det kan formere sig i de celler, det har inficeret.
English: Sustiva does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Danish: Sustiva helbreder ikke hiv-infektion eller aids, men kan sinke skader på immunsystemet og forhindre udviklingen af de infektioner og sygdomme, der er forbundet med aids.
English: Sustiva can affect the electrical activity of the heart and so must also not be used in patients with heart problems such as changes in heart rhythm and activity, slow heart rate or heart failure or other conditions that can affect the heart's electrical activity, or who have close relatives that have died suddenly from a heart condition or were born with heart problems.
Danish: Sustiva kan påvirke hjertets elektriske aktivitet og må derfor ikke anvendes hos patienter med hjerteproblemer som f.eks. forandringer i hjerterytmen og -aktiviteten, langsom hjertefrekvens eller hjertesvigt eller andre sygdomme, der kan påvirke hjertets elektriske aktivitet, eller hos patienter, der har pårørende, som pludseligt er døde af en hjertesygdom, eller som blev født med en hjertesygdom.
English: Sustiva must not be used in patients with severe liver disease.
Danish: Sustiva må ikke gives til patienter med svær leversygdom.
English: Sustiva can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Danish: Sustiva udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hiv-infektion.
English: The European Medicines Agency decided that Sustiva's benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents and children three months of age and older and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur vurderede, at fordelene ved Sustiva overstiger risiciene til behandling af hiv-inficerede voksne, unge og børn i alderen tre måneder og derover, og anbefalede, at det godkendes til anvendelse i EU.
English: For patients who cannot swallow, the capsule contents can be mixed with a small amount of food (one or two teaspoons).
Danish: Patienter, der ikke kan synke kapsler, kan få indholdet af kapslerne opblandet med lidt mad (1-2 teskefulde).
English: Sustiva is also commonly associated with dizziness, headache, nausea (feeling sick) and tiredness.
Danish: Sustiva forbindes ofte med svimmelhed, hovedpine, kvalme og træthed.
English: What are the risks associated with Sustiva?
Danish: Hvilke risici er der forbundet med Sustiva?
English: The most common side effect with Sustiva (seen in more than 1 patient in 10) is rash.
Danish: Den hyppigste bivirkning ved Sustiva (som optræder hos flere end 1 ud af 10 patienter) er udslæt.
English: In all of the studies, the main measure of effectiveness was the number of patients with undetectable levels of HIV 1 in their blood (viral loads) after 24 or 48 weeks of treatment:
Danish: I alle undersøgelserne var det primære mål for virkning antallet af patienter, hos hvem der ikke kunne påvises hiv-1 i blodet (virusbelastning) efter 24 eller 48 ugers behandling:
English: Sustiva is an antiviral medicine that is used together with other antiviral medicines to treat patients aged 3 months or older and weighing at least 3.5 kg, who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Sustiva er et antiviralt lægemiddel, der anvendes sammen med andre antivirale lægemidler til behandling af patienter i alderen tre måneder eller derover og med en kropsvægt på mindst 3,5 kg, som er smittet med humant immundefektvirus type 1 (hiv-1, et virus, som forårsager erhvervet immundefektsyndrom (aids)).
English: For more information about treatment with Sustiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sustiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: 67% of the adults treated with Sustiva in combination with zidovudine and lamivudine had viral loads below 400 copies/ml after 48 weeks, compared with 54% of the patients treated with Sustiva and indinavir, and 45% of the patients treated with indinavir, lamivudine and zidovudine;
Danish: 67 % af de voksne, der blev behandlet med Sustiva i kombination med zidovudin og lamivudin, havde en virusbelastning på mindre end 400 kopier/ml efter 48 uger, sammenlignet med 54 % for de patienter, der blev behandlet med Sustiva og indinavir, og 45 % for de patienter, der blev behandlet med indinavir, lamivudin og zidovudin.
English: The Sustiva combination was more effective than the combination without Sustiva: 70% and 30% of the patients, respectively, had viral loads below 500 copies/ml after 48 weeks;
Danish: Kombinationen med Sustiva var mere effektiv end kombinationen uden Sustiva: henholdsvis 70 % og 30 % af patienterne havde en virusbelastning på under 500 kopier/ml efter 48 ugers behandling.
English: The Agency noted that Sustiva has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Danish: Agenturet konstaterede, at Sustiva ikke er tilstrækkeligt undersøgt hos patienter med fremskreden sygdom (CD4-celletal under 50 celler/mm3) eller patienter, hos hvem protease-hæmmere (en anden type antiviral medicin) ikke har virket.
English: How is Sustiva used?
Danish: Hvordan anvendes Sustiva?
English: Taking Sustiva with food may lead to an increase in the frequency of side effects.
Danish: Hvis Sustiva indtages sammen med et måltid, kan dette øge forekomsten af bivirkninger.
English: • the second study compared Sustiva in combination with nelfinavir and two other antiviral medicines with the same combination without Sustiva.
Danish: • I den anden undersøgelse blev Sustiva i kombination med nelfinavir og to andre antivirale lægemidler sammenlignet med samme kombination uden Sustiva.