FrancophonIA/ELRC3.0 huggingface dataset:
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 - 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).
English: While you are taking Clopidogrel Krka:
Danish: Mens du er i behandling med Clopidogrel Krka:
English: What you need to know before you take Clopidogrel Krka
Danish: Det skal du vide, før du begynder at tage Clopidogrel Krka
English: 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.
Danish: 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.
English: 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
Danish: 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).
English: België/Belgique/Belgien KRKA Belgium, SA.
Danish: België/Belgique/Belgien
English: 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).
Danish: Kombinationsterapi bør startes så tidligt som muligt, og fortsættes i mindst 4 uger efter symptomerne viser sig.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: Clopidogrel Krka 75 mg film-coated tablets clopidogrel
Danish: Clopidogrel Krka 75 mg filmovertrukne tabletter clopidogrel
English: • If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for clopidogrel eller et af de øvrige indholdsstoffer i Clopidogrel Krka
English: Clopidogrel Krka 75 mg film-coated tablets
Danish: Clopidogrel Krka 75 mg filmovertrukne tabletter
English: If you take more Clopidogrel Krka than you should Contact your doctor or the nearest emergency department because of the increased risk of bleeding.
Danish: Kontakt din læge eller nærmeste skadestue, på grund af den øgede blødningsrisiko.
English: Do not take Clopidogrel Krka
Danish: Tag ikke Clopidogrel Krka
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse KRKA, d.d., Novo mesto
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Danish: Brug af anden medicin sammen med Clopidogrel 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.
English: KRKA Latvija SIA Tel: + 371 6 733 86 10
Danish: Tel: + 371 6 733 86 10
English: How to take Clopidogrel Krka
Danish: Sådan skal du tage Clopidogrel Krka
English: 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.
Danish: I CLARITY var der en generel stigning i antallet af blødninger i clopidrogrel plus ASA-gruppen versus placebo plus ASA-gruppen.
English: Tél/Tel: + 32 (0) 487 50 73 62
Danish: KRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62
English: - Severe hepatic impairment.
Danish: - Stærkt nedsat leverfunktion.
English: What Clopidogrel Krka 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: 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).
Danish: ticlopidin, prasugrel), da der er rapporteret om krydsreaktioner mellem thienopyridiner (se pkt.
English: If you stop taking Clopidogrel Krka
Danish: Hvis du har taget for megetClopidogrel Krka
English: What you need to know before you take Clopidogrel Krka 3.
Danish: Det skal du vide, før du begynder at tage Clopidogrel Krka Sådan skal du tage Clopidogrel Krka Bivirkninger
English: What Clopidogrel Krka contains - The active substance is clopidogrel.
Danish: Clopidogrel Krka 75 mg filmovertrukne tabletter indeholder: - Aktivt stof: clopidogrel.
English: Both active substances have been available in the European Union (EU) for a number of years.
Danish: Begge aktive stoffer har været på markedet i Den Europæiske Union (EU) i en række år.
English: It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome':
Danish: Det kan anvendes hos følgende grupper af patienter, der lider af »akut koronart syndrom«:
English: 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.
Danish: 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.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel/Acetylsalicylic acid Teva on 01 September 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel/Acetylsalicylsyre Teva den 1. september 2014.
English: 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.
Danish: 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.
English: Acetylsalicylic acid has been available for over 100 years.
Danish: Acetylsalicylsyre har været markedsført i over 100 år.
English: Clopidogrel has been authorised since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid.
Danish: Clopidogrel har været godkendt siden 1998 til nedsættelse af blodpladers sammenklumpning og anvendes ofte sammen med acetylsalicylsyre.
English: 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.
Danish: 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.
English: Clopidogrel/Acetylsalicylic acid Teva must not be used during the last three months of pregnancy.
Danish: Clopidogrel/Acetylsalicylsyre Teva må ikke bruges i de sidste tre måneder af graviditeten.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming.
Danish: Dette forhindrer blodpladerne i at blive »klæbrige« og nedsætter risikoen for blodpropper.
English: 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.
Danish: 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.
English: A risk management plan has been developed to ensure that Clopidogrel/Acetylsalicylic acid Teva is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Clopidogrel/Acetylsalicylsyre Teva anvendes så sikkert som muligt.
English: • 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;
Danish: • 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
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel/Acetylsalicylic acid Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel/Acetylsalicylsyre Teva.
English: 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.
Danish: 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.
English: This means that they help to prevent blood cells called platelets from sticking together and forming clots, thus helping to prevent another heart attack.
Danish: Det betyder, at de forhindrer blodpladerne i at hænge sammen og danne blodpropper, og at de derved forebygger flere hjerteanfald.
English: Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase.
Danish: Acetylsalicylsyre forhindrer blodpladerne i at hænge sammen ved at blokere enzymet prostaglandin cyclooxygenase.
English: 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.
Danish: 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.
English: Clopidogrel/Acetylsalicylic acid Teva is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
Danish: Clopidogrel/Acetylsalicylsyre Teva leveres som tabletter med 75 mg clopidogrel og enten 75 eller 100 mg acetylsalicylsyre.
English: Clopidogrel stops the platelets sticking together by blocking a substance called ADP from attaching to a special receptor on their surface.
Danish: Clopidogrel forhindrer blodpladerne i at hænge sammen ved at forhindre stoffet ADP i at bindes til en særlig receptor på blodpladernes overflade.
English: 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.
Danish: 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.
English: Clopidogrel/Acetylsalicylic acid Teva is a blood thinning medicine that contains two active substances, clopidogrel and acetylsalicylic acid.
Danish: Clopidogrel/Acetylsalicylsyre Teva er et blodfortyndende lægemiddel, der indeholder to aktive stoffer, clopidogrel og acetylsalicylsyre.
English: Both active substances in Clopidogrel/Acetylsalicylic acid Teva, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Danish: Begge aktive stoffer i Clopidogrel/Acetylsalicylsyre Teva, nemlig clopidogrel og acetylsalicylsyre, er antitrombocytmidler.
English: Clopidogrel/Acetylsalicylic acid Teva clopidogrel / acetylsalicylic acid
Danish: Clopidogrel/Acetylsalicylsyre Teva clopidogrel/acetylsalicylsyre
English: 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).
Danish: 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).
English: For practical information about using Clopidogrel/Acetylsalicylic acid Teva, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Clopidogrel/Acetylsalicylsyre Teva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Clopidogrel/Acetylsalicylic acid Teva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Clopidogrel/Acetylsalicylsyre Teva?
English: 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.
Danish: 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.
English: It is not intended to provide practical advice on how to use Clopidogrel/Acetylsalicylic acid Teva.
Danish: Det er ikke en praktisk vejledning i, hvordan Clopidogrel/Acetylsalicylsyre Teva bør anvendes.
English: This reduces the production of a substance called thromboxane, which normally helps clots to form by binding platelets together.
Danish: Dette nedsætter produktionen af stoffet thromboxan, der fremmer dannelse af blodpropper ved at få blodpladerne til at klumpe sammen.
English: Other information about Clopidogrel/Acetylsalicylic acid Teva
Danish: Andre oplysninger om Clopidogrel/Acetylsalicylsyre Teva
English: Clopidogrel/Acetylsalicylic acid Teva can only be obtained with a prescription.
Danish: Clopidogrel/Acetylsalicylsyre Teva udleveres kun efter recept.
English: What is Clopidogrel/Acetylsalicylic acid Teva and what is it used for?
Danish: Hvad er Clopidogrel/Acetylsalicylsyre Teva, og hvad anvendes det til?
English: For the full list of all side effects reported with Clopidogrel/Acetylsalicylic acid Teva, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Clopidogrel/Acetylsalicylsyre Teva fremgår af indlægssedlen.
English: What are the risks associated with Clopidogrel/Acetylsalicylic acid Teva?
Danish: Hvilke risici er der forbundet med Clopidogrel/Acetylsalicylsyre Teva?
English: It also presented the results of 3 previous studies involving in total over 61,000 patients with unstable angina or who had had a heart attack, which showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was more effective at preventing events such as heart attacks than acetylsalicylic acid alone.
Danish: Virksomheden fremlagde desuden resultater af tre tidligere undersøgelser med i alt over 61 000 patienter, der havde ustabil angina eller havde haft et hjerteanfald.
English: Why is Clopidogrel/Acetylsalicylic acid Teva approved?
Danish: Hvorfor er Clopidogrel/Acetylsalicylsyre Teva blevet godkendt?
English: It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain, or in patients with mastocytosis (high blood levels of certain white blood cells called mast cells).
Danish: Clopidogrel/Acetylsalicylsyre Teva må heller ikke anvendes ved sygdomme, der medfører blødning, såsom mavesår eller hjerneblødning, eller ved højt indhold af hvide blodlegemer af typen mastceller (mastocytose).
English: How is Clopidogrel/Acetylsalicylic acid Teva used?
Danish: Hvordan anvendes Clopidogrel/Acetylsalicylsyre Teva?
English: How does Clopidogrel/Acetylsalicylic acid Teva work?
Danish: Hvordan virker Clopidogrel/Acetylsalicylsyre Teva?
English: What benefits of Clopidogrel/Acetylsalicylic acid Teva have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Clopidogrel/Acetylsalicylsyre Teva?
English: Dublin 4, Ireland
Danish: Dublin 4, Irland
English: From a microbiological point of view the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes med det samme.
English: if you notice a change in your hearing.
Danish: hvis du bemærker en ændring i din hørelse.
English: Alternatively, your doctor may decide that this medicine is not suitable for you.
Danish: Alternativt kan din læge beslutte, at denne medicin ikke er velegnet til dig.
English: The dose given will depend on how much you weigh.
Danish: Dosis vil afhænge af, hvor meget du vejer.
English: A course of treatment usually lasts for 7 to 21 days.
Danish: En behandling varer normalt 7 til 21 dage.
English: Ask your doctor for advice before
Danish: Spørg din læge til råds, før du
English: Intermediate analysis results should be provided starting May 2015.
Danish: Intermediære analyseresultater skal sendes fra og med maj 2015.
English: Both effects were reversible following an 8 week recovery period.
Danish: Begge dele var reversible efter en restitutionperiode på 8 uger.
English: VIBATIV may cause the following side effects:
Danish: VIBATIV kan forårsage følgende bivirkninger:
English: At least 10,000 Gram-positive isolates per year shall be included in the study from the surveillance networks in Europe, USA, Latin America and Asia-Pacific.
Danish: Mindst 10.000 Grampositive prøver pr. år, fra overvågningsnetværket i Europa, USA, Latinamerika og Asien-stillehavsområdet, skal inkluderes i studiet.
English: Tell your doctor if you are pregnant, think you may be pregnant, or are trying to become pregnant.
Danish: Du skal fortælle din læge, hvis du er gravid, tror du er gravid eller planlægger at blive gravid.
English: The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms.
Danish: Brugen af antibiotika kan fremme overvækst af ikke følsomme mikroorganismer.
English: Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as
Danish: Da disse reaktioner er rapporteret fra en population af ukendt størrelse, er det ikke muligt at estimere frekvensen på en pålidelig måde, hvorfor de kategoriseres med
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelig: kan forekomme hos mere end 1 ud af 10 patienter
English: Fibrin degradation products
Danish: Fibrin nedbrydningsprodukter
English: Creatinine clearance* (ml/min)
Danish: Kreatininclearance * (ml/min)
English: VIBATIV can only be used when other antibiotics are not suitable.
Danish: VIBATIV anvendes kun, når andre antibiotika ikke er egnet.
English: See 4.2 for information on paediatric use.
Danish: 4.2 for information om pædiatrisk anvendelse.
English: S. aureus (including methicillin-resistant strains)
Danish: S. aureus (inklusive methicillinresistente stammer)
English: if you are allergic to antibiotics such as vancomycin.
Danish: hvis du er allergisk over for antibiotika såsom vancomycin.
English: It is only used when the bacteria that cause these infections can be killed with telavancin.
Danish: Det anvendes kun når bakterier, der forårsager disse infektioner, kan dræbes af telavancin.
English: The potential risk for humans
Danish: Den potentielle risiko for
English: Your doctor will decide how long you should be treated.
Danish: Din læge vil afgøre, hvor lang tid du skal behandles.
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Frekvensen af bivirkninger er defineret som følgende: 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), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Tell your doctor immediately if this is the case.
Danish: Fortæl det straks til din læge, hvis det er tilfældet.
English: Therefore, no dosage adjustment is necessary based on gender.
Danish: Dosisjustering på baggrund af køn er derfor ikke nødvendig.
English: Telavancin has a small volume of distribution.
Danish: Telavancin har et lille fordelingsvolumen.