natgillin/translations-raw huggingface dataset:
Hvis du blivergravid, mens du tager Clopidogrel Krka, skal du omgående kontakte din læge, da det frarådes at tage Clopidogrel Krka under graviditet.
If you become pregnant while taking Clopidogrel Krka, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Lejlighedsvis brug af acetylsalicylsyre (højst 1000 mg i løbet af et døgn) skulle generelt ikke give problemer.
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.
Blisterkort af OPA/Al/PVC-Al i æsker med 7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112 og 120 filmovertrukne tabletter.
Blister of OPA/Alu/PVC-Alu containing 7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112 and 120 filmcoated tablets in the box.
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 Krka.
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Krka.
Æsker med 7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112 og 120 filmovertrukne tabletter i blisterpakning.
Boxes of 7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112 and 120 film-coated tablets in blisters are available.
Hvis du holder op med at tage Clopidogrel Krka Du må ikke stoppe behandlingen, medmindre din læge fortæller dig, at du skal gøre det.
Do not stop the treatment unless your doctor tells you so.
Hvis du har haft alvorlige smerter i brystet (hjertekrampe (ustabil angina pectoris) eller hjerteanfald), kan din læge ordinere Clopidogrel Krka i kombination med acetylsalicylsyre, som er et stof, der indgår i mange typer medicin til smertelindring og febersænkning.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Krka in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
- Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
- Hypersensitivity to the active substance or to any of the excipients listed in section 2 or section
Du har fået ordineret Clopidogrel Krka 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).
You have been prescribed Clopidogrel Krka 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).
• Hvis du har en aktiv blødning såsom et mavesår eller en blødning i hjernen
• If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
Hvis du har haft alvorlige brystsmerter (ustabil angina pectoris eller hjertetilfælde), vil din læge måske indlede behandlingen med at give dig 300 mg Clopidogrel Krka på en gang (4 tabletter på 75 mg).
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Krka (4 tablets of 75 mg) once at the start of treatment.
Clopidogrel Krka tages af voksne for at forebygge dannelse af blodpropper (trombi) i blodårer (arterier), som er blevet stive ved en proces kaldet aterotrombose, hvilket kan føre til f.eks. apopleksi, hjerteanfald og død (aterotrombotiske hændelser).
Clopidogrel Krka 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).
Hvis du har glemt at tage Clopidogrel Krka
If you forget to take Clopidogrel Krka
• Voksne patienter med akut koronarsyndrom: - akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina eller myokardieinfarkt uden forekomst af Q-takker) inklusive patienter, som får indsat stent efter perkutant koronarindgreb, i kombination med acetylsalicylsyre (ASA).
- Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
- 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 og med eller uden trombolytika.
- 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.
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 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).
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, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge dinlæge eller apotekspersonalettil råds, før du tager Clopidogrel Krka.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Krka.
Hos patienter med akut koronarsyndrom - akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina pectoris eller myokardieinfarkt uden forekomst af Q-takker): Behandling med clopidogrel bør indledes med en enkelt initial mætningsdosis på 300 mg, hvorefter behandlingen består af 75 mg en gang daglig (sammen med acetylsalicylsyre (ASA) 75 mg - 325 mg/dag).
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).
Mens du er i behandling med Clopidogrel Krka:
While you are taking Clopidogrel Krka:
Det skal du vide, før du begynder at tage Clopidogrel Krka
What you need to know before you take Clopidogrel Krka
Den anbefalede dosis, herunder også til patienter med ”atrieflimmer” (uregelmæssig hjerterytme), er 1 Clopidogrel Krka-tablet på 75 mg dagligt på samme tidspunkt hver dag.
The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Krka per day to be taken orally with or without food, and at the same time each day.
Der var ikke tegn på karcinogen virkning, når clopidogrel blev administreret i 78 uger til mus og 104 uger til rotter og givet i doser op til 77 mg/kg/dag (hvilket udgør mindst 25 gange eksponeringen hos mennesker, der får den kliniske dosis på 75 mg/dag).
There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to
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).
Nyligt myokardieinfarkt (MI), nylig apopleksi eller påvist perifer arteriel lidelse CAPRIE-studiet omfattede 19.185 patienter med aterotrombose manifesteret ved nyligt myokardieinfarkt (<35 dage), nylig iskæmisk apopleksi (mellem 7 dage og 6 måneder) eller påviste perifere kredsløbsforstyrrelser (PAD).
The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (<35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Patienterne fik clopidogrel (300 mg loading dose efterfulgt af 75 mg daglig, n=1752) eller placebo (n=1739) begge i kombination med ASA (150-325 mg som loading dose, 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.
Clopidogrel Krka 75 mg filmovertrukne tabletter clopidogrel
Clopidogrel Krka 75 mg film-coated tablets clopidogrel
• Hvis du er allergisk over for clopidogrel eller et af de øvrige indholdsstoffer i Clopidogrel Krka
• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
Clopidogrel Krka 75 mg filmovertrukne tabletter
Clopidogrel Krka 75 mg film-coated tablets
Kontakt din læge eller nærmeste skadestue, på grund af den øgede blødningsrisiko.
If you take more Clopidogrel Krka than you should Contact your doctor or the nearest emergency department because of the increased risk of bleeding.
Tag ikke Clopidogrel Krka
Do not take Clopidogrel Krka
Navn og adresse på fremstilleren ansvarlig for batchfrigivelse KRKA, d.d., Novo mesto
Name and address of the manufacturer(s) responsible for batch release
Brug af anden medicin sammen med Clopidogrel Krka Fortæl det altid till lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Sådan skal du tage Clopidogrel Krka
How to take Clopidogrel Krka
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.
- Stærkt nedsat leverfunktion.
- Severe hepatic impairment.
De filmovertrukne tabletter er lyserøde, runde og let hvælvede.
What Clopidogrel Krka looks like and contents of the pack The film-coated tablets are pink, round and slightly convex.
ticlopidin, prasugrel), da der er rapporteret om krydsreaktioner mellem thienopyridiner (se pkt.
Patients should be evaluated for history of hypersensitivity to thienopyridines (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section 4.8).
Hvis du har taget for megetClopidogrel Krka
If you stop taking Clopidogrel Krka
Det skal du vide, før du begynder at tage Clopidogrel Krka Sådan skal du tage Clopidogrel Krka Bivirkninger
What you need to know before you take Clopidogrel Krka 3.
Clopidogrel Krka 75 mg filmovertrukne tabletter indeholder: - Aktivt stof: clopidogrel.
What Clopidogrel Krka contains - The active substance is clopidogrel.
Begge aktive stoffer har været på markedet i Den Europæiske Union (EU) i en række år.
Both active substances have been available in the European Union (EU) for a number of years.
Det kan anvendes hos følgende grupper af patienter, der lider af »akut koronart syndrom«:
It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome':
Udvalget fandt desuden, at kombinationen af de to aktive stoffer i én tablet forenkler behandlingen for patienterne, da de ikke behøver tage så mange tabletter.
The Committee also considered that combining both active substances in a single tablet simplifies treatment for patients as they will need to take fewer tablets.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel/Acetylsalicylsyre Teva den 1. september 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel/Acetylsalicylic acid Teva on 01 September 2014.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Clopidogrel/Acetylsalicylsyre Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Clopidogrel/Acetylsalicylic acid Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Acetylsalicylsyre har været markedsført i over 100 år.
Acetylsalicylic acid has been available for over 100 years.
Clopidogrel har været godkendt siden 1998 til nedsættelse af blodpladers sammenklumpning og anvendes ofte sammen med acetylsalicylsyre.
Clopidogrel has been authorised since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Clopidogrel/Acetylsalicylsyre Teva opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel/Acetylsalicylic acid Teva's benefits are greater than its risks and recommended that it be approved for use in the EU.
Clopidogrel/Acetylsalicylsyre Teva må ikke bruges i de sidste tre måneder af graviditeten.
Clopidogrel/Acetylsalicylic acid Teva must not be used during the last three months of pregnancy.
Lægemidlet tages som en enkelt tablet dagligt i stedet for de tabletter med Clopidogrel og acetylsalicylsyre, som patienten i forvejen har taget hver for sig.
The medicine is taken as a single tablet daily in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
CHMP bemærkede, at de to aktive stoffer i Clopidogrel/Acetylsalicylsyre Teva havde været anvendt i en årrække til at mindske risikoen for hjerteanfald, og at de i kombination mindsker risikoen mere end hver bestanddel alene.
The CHMP noted that both active substances in Clopidogrel/Acetylsalicylic acid Teva have been used for several years to reduce the risk of heart attack and when taken together they can reduce the risk more than each component can alone.
Det anvendes til at forebygge problemer forårsaget af blodpropper, såsom hjerteanfald, hos voksne, der i forvejen får både clopidogrel og acetylsalicylsyre (der også kaldes aspirin) som separate tabletter.
It is used to prevent problems caused by blood clots, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid (known commonly as aspirin) as separate tablets.
Dette forhindrer blodpladerne i at blive »klæbrige« og nedsætter risikoen for blodpropper.
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Clopidogrel/Acetylsalicylsyre Teva, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Clopidogrel/Acetylsalicylic acid Teva, including the appropriate precautions to be followed by healthcare professionals and patients.
Der er udarbejdet en risikostyringsplan for at sikre, at Clopidogrel/Acetylsalicylsyre Teva anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Clopidogrel/Acetylsalicylic acid Teva is used as safely as possible.
• patienter, der har svære, ustabile brystsmerter (angina) eller har haft et hjerteanfald uden den unormale forandring i elektrokardiogrammet (»ST-segmentøgning«), herunder patienter, der har fået indsat en kort slange (en stent) i en arterie for at undgå, at den blokeres
• patients who have unstable angina (a severe type of chest pain) or have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel/Acetylsalicylsyre Teva.
This is a summary of the European public assessment report (EPAR) for Clopidogrel/Acetylsalicylic acid Teva.
De hyppigste bivirkninger ved Clopidogrel/Acetylsalicylsyre Teva (som kan forekomme hos op til 1 ud af 10 personer) er blodansamling under huden (hæmatom), næseblødning (epistaxis), mavetarmblødning (gastrointestinal blødning), mavesmerter (abdominalsmerter), halsbrand (dyspepsi), blå mærker og blødning, når der prikkes hul i huden.
The most common side effects with Clopidogrel/Acetylsalicylic acid Teva (which may affect up to 1 in 10 people) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin is punctured.
Det betyder, at de forhindrer blodpladerne i at hænge sammen og danne blodpropper, og at de derved forebygger flere hjerteanfald.
This means that they help to prevent blood cells called platelets from sticking together and forming clots, thus helping to prevent another heart attack.
Acetylsalicylsyre forhindrer blodpladerne i at hænge sammen ved at blokere enzymet prostaglandin cyclooxygenase.
Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase.
Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel/Acetylsalicylsyre Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Clopidogrel/Acetylsalicylic acid Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Clopidogrel/Acetylsalicylsyre Teva leveres som tabletter med 75 mg clopidogrel og enten 75 eller 100 mg acetylsalicylsyre.
Clopidogrel/Acetylsalicylic acid Teva is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
Clopidogrel forhindrer blodpladerne i at hænge sammen ved at forhindre stoffet ADP i at bindes til en særlig receptor på blodpladernes overflade.
Clopidogrel stops the platelets sticking together by blocking a substance called ADP from attaching to a special receptor on their surface.
Clopidogrel/Acetylsalicylsyre Teva må ikke anvendes hos personer, der er overfølsomme (allergiske) over for clopidogrel og acetylsalicylsyre, nonsteroide antiinflammatoriske lægemidler, der lindrer smerter og inflammation (NSAID), såsom acetylsalicylsyre, eller andre af indholdsstofferne i Clopidogrel/Acetylsalicylsyre Teva.
Clopidogrel/Acetylsalicylic acid Teva must not be used in people who are hypersensitive (allergic) to clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve pain and inflammation) such as acetylsalicylic acid, or any of the other ingredients in Clopidogrel/Acetylsalicylic acid Teva.
Clopidogrel/Acetylsalicylsyre Teva er et blodfortyndende lægemiddel, der indeholder to aktive stoffer, clopidogrel og acetylsalicylsyre.
Clopidogrel/Acetylsalicylic acid Teva is a blood thinning medicine that contains two active substances, clopidogrel and acetylsalicylic acid.
Begge aktive stoffer i Clopidogrel/Acetylsalicylsyre Teva, nemlig clopidogrel og acetylsalicylsyre, er antitrombocytmidler.
Both active substances in Clopidogrel/Acetylsalicylic acid Teva, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Clopidogrel/Acetylsalicylsyre Teva clopidogrel/acetylsalicylsyre
Clopidogrel/Acetylsalicylic acid Teva clopidogrel / acetylsalicylic acid
Det må ikke anvendes ved svært nedsat lever- eller nyrefunktion, eller hos patienter med en kombination af astma, tilstoppet og løbende næse (rhinitis) og udposninger af næseslimhinden (polypper).
It must not be used in patients who have severely reduced liver or kidney function, or who have a medical condition that includes a combination of asthma, rhinitis (stuffy and runny nose) and nasal polyps (growths in the lining of the nose).
Hvis du ønsker praktisk vejledning om anvendelsen af Clopidogrel/Acetylsalicylsyre Teva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Clopidogrel/Acetylsalicylic acid Teva, patients should read the package leaflet or contact their doctor or pharmacist.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Clopidogrel/Acetylsalicylsyre Teva?
What measures are being taken to ensure the safe and effective use of Clopidogrel/Acetylsalicylic acid Teva?
Virksomheden fremlagde derfor undersøgelser, der viser, at de aktive stoffer i Clopidogrel/Acetylsalicylsyre Teva optages på samme måde i kroppen, når de tages som en enkelt tablet, som når de to lægemidler tages hvert for sig.
Because the two active substances have been used together for a number of years, the company presented the results of studies showing that the active substances in Clopidogrel/Acetylsalicylic acid Teva are absorbed in the body in the same way when taken in a single tablet as when the two medicines are taken separately.
Det er ikke en praktisk vejledning i, hvordan Clopidogrel/Acetylsalicylsyre Teva bør anvendes.
It is not intended to provide practical advice on how to use Clopidogrel/Acetylsalicylic acid Teva.
Dette nedsætter produktionen af stoffet thromboxan, der fremmer dannelse af blodpropper ved at få blodpladerne til at klumpe sammen.
This reduces the production of a substance called thromboxane, which normally helps clots to form by binding platelets together.
Andre oplysninger om Clopidogrel/Acetylsalicylsyre Teva
Other information about Clopidogrel/Acetylsalicylic acid Teva
Clopidogrel/Acetylsalicylsyre Teva udleveres kun efter recept.
Clopidogrel/Acetylsalicylic acid Teva can only be obtained with a prescription.
Hvad er Clopidogrel/Acetylsalicylsyre Teva, og hvad anvendes det til?
What is Clopidogrel/Acetylsalicylic acid Teva and what is it used for?