natgillin/translations-raw huggingface dataset:
Opfølgning ved et år blev udført for 316 patienter (98,1%) i de-eskaleret DAPT-gruppen og 318 patienter (98,5%) i den uændrede DAPT-gruppe.
(98.1%) in the de-escalated DAPT group and 318 patients (98.5%) in the unchanged DAPT group.
Din læge bør have udskrevet Clopidogrel Krka d.d.
Your doctor should have prescribed Clopidogrel Krka d.d.
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.
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).
Der skal udvises forsigtighed ved samtidig administration af lægemidler, der er forbundet med risiko for blødning (se pkt.
The concomitant administration of medicinal products associated with bleeding risk should be undertaken with caution (see section 4.4).
Gastrointestinal blødning, diarré, mavesmerter, dyspepsi
Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
73% af de inkluderede patienter i ACTIVE-A-studiet kunne ikke tage VKA på grund af en lægelig vurdering, manglende evne til at overholde INR (international normaliseret ratio)-monitorering, disposition for fald eller hovedtraume eller en specifik risiko for blødning.
Seventy-three percent (73%) of patients enrolled into the ACTIVE-A study were unable to take VKA due to physician assessment, inability to comply with INR (international normalised ratio) monitoring, predisposition to falling or head trauma, or specific risk of bleeding; for 26% of the patients, the physician's decision was based on the patient's unwillingness to take VKA.
De filmovertrukne tabletter er lyserøde, runde og let hvælvede.
looks like and contents of the pack The film-coated tablets are pink, round and slightly convex.
Mavesår og duodenalt ulcus, gastritis, opkastning, kvalme, forstoppelse, flatulens
Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
BLISTERKORT
BLISTER
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, 29 %, når de fik perkutan transluminal koronar angioplastik (PTCA) med eller uden stent, og 10 %, når de fik koronar bypassoperation (CABG).
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)).
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 dagligt) samt anden standardbehandling.
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.
Er du i tvivl, så spørg lægen eller apotekspersonalet.
- If you have any further questions, ask your doctor or your pharmacist.
Samtidig anvendelse af clopidogrel og boostet antiretroviral terapi bør derfor frarådes.
Therefore, concomitant use of clopidogrel with boosted ART should be discouraged.
Som forholdsregel frarådes samtidig anvendelse af omeprazol eller esomeprazol (se pkt.
As a precaution, concomitant use of omeprazole or esomeprazole should be discouraged (see section 4.4).
Inden for hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter, hvor alvorlige de er.
Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
• 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 (sammen med acetylsalicylsyre (ASA) 75 mg - 325 mg dagligt).
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).
Clopidogrel er indiceret hos:
Secondary prevention of atherothrombotic events Clopidogrel is indicated in:
Kombinationsterapi bør startes så tidligt som muligt og fortsættes i mindst 4 uger efter symptomerne viser sig.
Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
Hvis du blivergravid, mens du tager Clopidogrel Krka d.d., skal du omgående kontakte din læge, da det frarådes at tage Clopidogrel Krka d.d.
If you become pregnant while taking Clopidogrel Krka d.d., consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Fertilitet I dyreforsøg blev det ikke vist, at Clopidogrel ændrer fertiliteten.
Fertility Clopidogrel was not shown to alter fertility in animal studies.
Den aktive metabolit dannes hovedsageligt af CYP2C19 med bidrag fra flere andre CYP-enzymer, inklusive CYP1A2, CYP2B6 og CYP3A4.
The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.The active thiol metabolite which has been isolated in vitro, binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation.
Det skal du vide, før du begynder at tage Clopidogrel Krka d.d.
What you need to know before you take Clopidogrel Krka d.d.
Muskuloskeletal muskler og bindevæv blødning (blødudtrædning i led), artrit, arthralgi, muskelsmerter.
Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
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).
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.
4.4), aplastisk anæmi, pancytopeni, agranulocytose, alvorlig trombocytopeni, erhvervet hæmofili A, granulocytopeni, anæmi
Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
Hvis du har glemt at tage Clopidogrel Krka d.d.
If you forget to take Clopidogrel Krka d.d.
I overensstemmelse med resultaterne ovenfor blev det vist i en metaanalyse af 6 studier med 335 clopidogrelbehandlede ved steady state, at eksponeringen for den aktive metabolit blev nedsat med 28 % hos intermediate metabolisers og med 72 % hos poor metabolisers.
Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
Navn og adresse på fremstilleren ansvarlig for batchfrigivelse KRKA, d.d., Novo mesto
Name and address of the manufacturer responsible for batch release
Du har fået ordineret Clopidogrel Krka d.d.
You have been prescribed Clopidogrel Krka d.d.
• Hvis du er allergisk over for clopidogrel eller et af de øvrige indholdsstoffer i Clopidogrel Krka d.d.
• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
Antallet af patienter, som oplevede det primære endepunkt (kardiovaskulært dødsfald, myokardieinfarkt, apopleksi eller refraktær iskæmi) var 1.035 (16,5 %) i clopidogrelgruppen og 1187 (18,8 %) i placebogruppen, hvilket giver en relativ risikoreduktion på 14 % (95 % CI: 6 %-21 %; p=0,00005) for clopidogrelgruppen.
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.
Patienterne fik clopidogrel (300 mg initial stabiliseringsdosis efterfulgt af 75 mg daglig, n=1.752) eller placebo (n=1739) begge i kombination med ASA (150-325 mg som initial stabiliseringsdosis, herefter 75-162 mg daglig), et fibrinolytisk middel samt heparin, når det var hensigtsmæssigt.
Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1752) or placebo (n=1739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Der var flere intrakranielle blødninger i clopidogrel + ASAgruppen sammenlignet med placebo + ASA-gruppen (1,4% versus 0,8%, henholdsvis).
ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
Hos de patienter, som alene indgik i studiet på grund af et nyligt myokardieinfarkt, lå clopidogrel numerisk lavere, men ikke statistisk forskelligt fra ASA (RRR = 4,0 %, CI: -22,5 til 11,7 [p=0,639]).
In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR =
Efter gentagen dosering med clopidogrel 75 mg daglig var hæmningen af ADP-induceret trombocytaggregation lavere (25 %) hos forsøgspersoner med alvorlig nyresygdom (kreatininclearance 5-15 ml/min) end der, der blev set hos raske forsøgspersoner.
After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Hvis du holder op med at tage Clopidogrel Krka d.d.
If you stop taking Clopidogrel Krka d.d.
C-mærket clopidogrel hos mennesker blev ca. 50 % udskilt i urinen og ca.
Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
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.
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
Tag ikke Clopidogrel Krka d.d.
Do not take Clopidogrel Krka d.d.
I CLARITY var der en generel stigning i antallet af blødninger i clopidrogrel plus ASA-gruppen versus placebo plus ASA-gruppen.
In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group .The incidence of major bleeding was similar between groups .
• 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
: - 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).
Som forholdsregel frarådes samtidig anvendelse af potente eller moderate CYP2C19-hæmmere (se pkt.
As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Glykoprotein IIb/IIIa-hæmmere: Clopidogrel skal anvendes med forsigtighed til patienter med øget risiko for blødninger pga. traumer, kirurgi eller andre patologiske tilstande, hvor patienten samtidigt behandles med glykoprotein IIb/IIIa-hæmmere (se pkt.
Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Derefter er den anbefalede dosis én Clopidogrel Krka d.d.-tablet på75mg dagligt,som beskrevet ovenfor.
Then, the recommended dose is one 75 mg tablet of Clopidogrel Krka d.d.
• kan det tage lidt længere end normalt, før blødningen stopper, hvis du skærer dig eller kommer til skade.
• If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Brug af anden medicin sammen med Clopidogrel Krka d.d.
Other medicines and Clopidogrel Krka d.d.
Spørg lægen eller apoteksperonalet, hvis der er noget, du er i tvivl om.
Check with your doctor or pharmacist if you are not sure.
Mens du er i behandling med Clopidogrel Krka d.d.
While you are taking Clopidogrel Krka d.d.
Gentagne doser på 75 mg/dag hæmmede i væsentlig grad den trombocytaggregation som ADP inducerer fra den første dag.
Repeated doses of 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7.
ASA og 924 (24,4 %) i placebo + ASA-gruppen (relativ risikoreduktion 11,1 %; 95 % CI 2,4 % til 19,1 %, p = 0,013).
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.
4.4)*, insulin autoimmun syndrom, som kan føre til alvorlig hypoglykæmi, især hos patienter med HLA
Serum sickness, anaphylactoid reactions cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*
Atrieflimren
Haematoma
- Kontakt med lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt i denne indlægsseddel.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
2 eller pkt.
is and what it is used for 2.
Det primære endepunkt (den kombinerede forekomst af CV-død, MI, slagtilfælde og BARC ≥2 blødning efter 12 måneder) blev mødt, hvilket viste non-inferioritet - 95 patienter (7%) i den guidede de-eskaleringsgruppe og 118 patienter (9%) i kontrolgruppen (p non-inferioritet = 0,0004) havde en hændelse.
Ninety five patients (7%) in the guided de-escalation group and 118 patients (9%) in the control group (p non-inferiority=0.0004) had an event.
Anvendelse af lægemidler, der hæmmer aktiviteten af CYP2C19, kan forventes at resultere i nedsat niveau af clopidogrels aktive metabolit og dermed nedsat klinisk virkning, da clopidogrel til dels metaboliseres til dets aktive metabolit af CYP2C19.
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Brug af Clopidogrel Krka d.d.
How to store Clopidogrel Krka d.d.
Šmarješka cesta 6
KRKA, d.d., Novo mesto Šmarješka cesta 6
Oversigt over bivirkninger i tabelform
SUMMARY OF PRODUCT CHARACTERISTICS
Sådan skal du tage Clopidogrel Krka d.d.
How to take Clopidogrel Krka d.d.
PRODUKTRESUME
Gynaecomastia
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 +
The primary endpoint (the combined incidence of CV death, MI, stroke and BARC bleeding grade ≥2 at 12 months) was met showing non-inferiority.
IndgivelsesvejEmballageIndhold Pakningsstø rrelse
Packaging Content Package size
Beholder med
Strength
EU-nummer
EMA Number
(Sær)navn Styrke
(Invented) name
Emballage Pakningsstørrelse
Immediate Packaging
Den 29. maj 2013 EMA/313994/2013
29 May 2013 EMA/313994/2013
Agenturets anbefalinger er baseret på en EU-dækkende sikkerhedsgennemgang.
The Agency's recommendations are based on an EU-wide safety review.
Gennemgangen af lægemidler indeholdende almitrin blev indledt i december 2012 på anmodning af Frankrig i henhold til artikel 31 i direktiv 2001/83/EF.
The review of oral almitrine-containing medicines was initiated in December 2012 at the request of France, under Article 31 of Directive 2001/83/EC.
Oralt almitrin vil blive trukket tilbage af EU's medlemsstater
Oral almitrine to be withdrawn by EU Member States
PRAC bemærkede, at der fortsat indberettes tilfælde, selv efter at der er indført supplerende forsigtighedsregler for anvendelsen af lægemidlerne.
The PRAC noted that cases continue to be reported even after additional precautions on the use of the medicines were put in place.
I 489 tilfælde blev neuropatien angivet at have været irreversibel eller at have medført sequelae.
In 489 cases, neuropathy was indicated to have been irreversible, or to have led to sequelae.
I de spontane indberetninger beskrives 7 tilfælde af vægttab og 20 tilfælde af perifer neuropati siden september 2003, da alle disse foranstaltninger var sat i værk.
Of the spontaneous reports, 7 cases of weight loss and 20 of peripheral neuropathy had been reported since September 2003 when all these measures were in operation.
CMDh tilsluttede sig PRAC's konklusion om, at fordelene ved disse lægemidler ikke opvejer risiciene, og vedtog som sit endelige standpunkt, at markedsføringstilladelserne bør inddrages i hele EU.
The CMDh agreed with the PRAC conclusion that the benefits of these medicines do not outweigh their risks, and adopted a final position that the marketing authorisations should be withdrawn throughout the EU.
• Da det er påvist, at almitrin medfører risiko for beskadigelse af nerverne i hænder og fødder samt vægttab, og da der i dag findes en række andre behandlingsmuligheder, vil det blive trukket tilbage i hele EU.
• Because almitrine has been shown to carry a risk of damage to the nerves in the hands and feet as well as weight loss, and because a number of alternative treatments are now available, it will be withdrawn across the EU.
• Ordinerende læger og apoteker vil få tilsendt et brev med yderligere information om tilbagetrækningen af oralt almitrin.
• Prescribers and pharmacists will be sent a letter giving them further information on the withdrawal of oral almitrine.
• PRAC bemærkede, at der fortsat er blevet indberettet tilfælde af vægttab og perifer neuropati trods indførelsen af en række risikominimeringsforanstaltninger, herunder sekventiel administration (to måneders behandling efterfulgt af en måneds pause), dosisreduktion og passende advarsler i produktinformationen.
• The PRAC noted that cases of weight loss and peripheral neuropathy have continued to be reported, despite the introduction of a number of risk minimisation measures, including sequential administration (two months treatment followed by a one-month break), dose reduction and appropriate warnings in the product information.
Yderligere resultater fra kliniske undersøgelser tydede på, at neuropati oftest forekommer efter en behandlingsvarighed på tre måneder eller længere.
Additional results from clinical studies suggested that neuropathy was most common after three months or more of treatment.
CMDh er et organ, der repræsenterer EEA's medlemsstater og har ansvar for at sikre harmoniserede sikkerhedsnormer i hele EU for lægemidler, der godkendes ved nationale procedurer.
The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Da lægemidler indeholdende almitrin alle er godkendt nationalt, blev anbefalingerne fra PRAC overgivet til koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human (CMDh), som vedtog et endeligt standpunkt.
As almitrine-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Patienter, der ønsker yderligere oplysninger, bør kontakte lægen eller apotekspersonalet.
Patients who have any questions should speak to their doctor or pharmacist.
Almitrin er en stimulans af den del af hjernen, der er ansvarlig for vejrtrækningsrefleksen.
Almitrine is a stimulant of the part of the brain responsible for the breathing reflex.
• Indsigten i KOL og dens behandlingsmuligheder har ændret sig betydeligt siden den oprindelige godkendelse af oralt almitrin.
• The understanding of COPD and the therapeutic options for its management have changed considerably since the original authorisation of oral almitrine.
Den virksomhed, der markedsfører almitrin, konstaterede 795 spontant indberettede tilfælde af vægttab og 2 304 tilfælde af perifer neuropati i løbet af den 30-årige periode, hvor lægemidlet er blevet markedsført (svarende til flere millioner patientmåneders behandling).
The company marketing almitrine identified 795 spontaneously reported cases of weight loss and 2,304 cases of peripheral neuropathy over the 30-year period that the medicine has been marketed (representing several million patient months of treatment).
• Patienter i behandling med oralt almitrin bør få behandlingen gennemgået ved næste planlagte konsultation hos lægen, og der bør overvejes andre egnede behandlingsmuligheder.
• Patients being treated with oral almitrine should have their treatment reviewed at the next scheduled appointment, and appropriate alternative treatments should be considered.