natgillin/translations-raw huggingface dataset:
51 Belgique/ België/ Belgien Merck Sharp & Dohme B. V.
België/Belgique/Belgien Merck Sharp & Dohme B.V.
Tel: +356 2540 2600 medinfo_ mt@ merck. com
Tel: +356 2397 6100 medinfo_mt@merck.com
Tel: +43 (0) 1 26 044 Msd- medizin@ merck. com
Tel: +43 (0) 1 26 044 msd-medizin@merck.com
Portugal Merck Sharp & Dohme, Lda Tel: +351 21 446 57 00 informacao_ doente@ merck. com
Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700 informacao_doente@merck.com
France Laboratoires Merck Sharp & Dohme - Chibret Tél: +33 (0) 1 47 54 87 00 contact@ msd- france. com
France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0) 1 47 54 87 00 contact@msd-france.com
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0) 1 2998700 medinfo_ ireland@ merck. com
Ireland Merck Sharp and Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
52 Ísland Icepharma hf.
Ísland Icepharma hf.
Tel: +39 06 361911 doccen@ meck. com
Ιtalia Addenda Pharma S.r.l. tel.: + 39 06 91393303 info@addenda.it
Tel: +371 7364 224 msd_ lv@ merck. com
Latvija SIA “Merck Sharp & Dohme Latvija” Tel: +371 7364 224 msd_lv@merck.com
United Kingdom Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medinfo_ uk@ merck. com
United Kingdom Merck Sharp and Dohme Limited Tel: +44 (0) 1992 467272 medinfo_uk@merck.com
Lietuva UAB “ Merck Sharp & Dohme ” Tel.: +370 5 278 02 47 msd_ lietuva@ merck. com
Lietuva UAB “Merck Sharp & Dohme” Tel. +370 5 278 02 47 msd_lietuva@merck.com
53 INDLÆGSSEDDEL:
53 PACKAGE LEAFLET:
Efficib 50 mg/ 1. 000 mg filmovertrukne tabletter (sitagliptin/ metforminhydrochlorid)
Efficib 50 mg/1000 mg film-coated tablets sitagliptin/metformin hydrochloride
Sammen kontrollerer de blodsukkeret hos patienter med type 2- diabetes mellitus.
They work together to control blood sugar levels in patients with a form of diabetes called ‘type 2 diabetes mellitus’.
54 2.
2.
nødvendigt at stoppe med Efficib på tidspunktet for røntgenundersøgelsen og et par dage efter.
taking Efficib at the time of the X -ray and for a few days after
- Hvis De for nylig har haft et hjerteanfald eller har alvorlige kredsløbsproblemer, herunder shock
- if you have recently had a heart attack or have severe circulatory problems, such as ‘shock’ or
Dette kaldes også insulin- afhængig diabetes.
This is sometimes called insulin -dependent diabetes
- Hvis De skal opereres under fuld bedøvelse, eller ved rygmarvsbedøvelse eller epiduralblokade,
You may
da det så kan være nødvendigt at stoppe med at tage Efficib i et par dage før og efter operationen.
need to stop taking Efficib for a couple of days before and after the procedure
Følgende medicin er særligt vigtig: • Medicin, der anvendes til behandling af sygdomme, som medfører betændelsestilstande, som astma og gigt (kortokosteroider). • Særlig medicin til behandling af forhøjet blodtryk (ACE- hæmmere). • Medicin, som øger urinproduktionen (vanddrivende medicin). • Særlig medicin til behandling af bronkial astma (beta- sympatomimetika).
The following medicines are particularly important: • medicines used to treat diseases that involve inflammation, like asthma and arthritis (corticosteroids) • specific medicines for the treatment of high blood pressure (ACE inhibitors) • medicines which increase urine production (diuretics) • specific medicines for the treatment of bronchial asthma (β-sympathomimetics) • iodinated contrast agents or alcohol-containing medicines.
Brug af Efficib sammen med mad og drikke Tag Efficib sammen med et måltid for at undgå at få problemer med maven.
Taking Efficib with food and drink Take Efficib with meals to lower your chance of an upset stomach.
Metformin går over i modermælken i små mængder.
55 Metformin passes into human milk in small amounts.
• • De bør tage Efficib:
• Efficib should be taken:
56 Hvis De har glemt at tage Efficib Hvis De glemmer en dosis, så tag den så snart De kommer i tanke om det.
If you forget to take Efficib If you miss a dose, take it as soon as you remember.
De må ikke tage en dobbeltdosis som erstatning for den glemte dosis Efficib.
Do not take a double dose of Efficib.
Almindelig:
Some patients have experienced the following side effects while taking sitagliptin alone:
Svimmelhed, forstoppelse.
Common: low blood sugar, headache Uncommon: dizziness, constipation
Nogle patienter har oplevet følgende bivirkninger, mens de har taget metformin alene:
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
57 Meget almindelige:
57 5.
Hver filmovertrukken tablet indeholder 50 mg
Each film -coated tablet contains 50 mg of
sitagliptin (som phosphatmonohydrat) og 1. 000 mg metforminhydrochlorid.
sitagliptin (as phosphate monohydrate) and 1000 mg of metformin hydrochloride.
58 Belgique/ België/ Belgien Merck Sharp & Dohme B. V.
België/Belgique/Belgien Merck Sharp & Dohme B.V.
BETINGELSER ELLER RESTRIKTIONER MED HENSYN TIL SIKKERHED OG EFFEKTIV BRUG AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF MEDLEMSSTATERNE
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 BETINGELSER ELLER RESTRIKTIONER MED HENSYN TIL SIKKERHED OG EFFEKTIV BRUG AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF MEDLEMSSTATERNE
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
4. 4), bør det ordineres som en 60 mg stabiliseringsdosis efterfulgt af en lavere vedligeholdelsesdosis på 5 mg. behandling. o Patienter med en vægt < 60 kg bør have en reduceret vedligeholdelsesdosis på 5 mg. o Evidensen for en dosis på 5 mg er kun baseret på farmakodynamiske/ farmakokinetiske analyser, og der er ingen tilgængelige kliniske data vedrørende sikkerheden for denne dosis for risikogrupperne.
The educational material should include: • A copy of the SPC • Emphasis that: o Severe haemorrhagic events are more frequent in patients ≥ 75 years of age (including fatal events) or those weighing < 60 kg o Treatment with prasugrel is generally not recommended for patients of ≥ 75 years of age. o If, after a careful individual benefit/ risk evaluation by the prescribing physician, treatment is deemed necessary in the ≥ 75 years age group then following a loading dose of 60 mg, a reduced maintenance dose of 5mg should be prescribed. o Patients weighing < 60 kg should have a reduced maintenance dose of 5mg o The evidence for a 5mg dose is based only on PK/ PD analyses and no clinical data currently exist on the safety of this dose in the at risk sub groups.
Det fås som tabletter med form som en aflang sekskant (gule:
It is available as double-arrow- shaped tablets (yellow:
5 mg; beige:
5 mg; beige:
Akut koronarsyndrom er en gruppe lidelser, der omfatter ustabil angina (en type alvorlige brystsmerter) og hjerteanfald.
Acute coronary syndrome is a group of conditions that includes unstable angina (a severe type of chest pain) and heart attack.
Perkutan koronarintervention er en operation, der udføres for at fjerne blokeringer i forsnævrede koronararterier (blodkar i hjertet).
Percutaneous coronary intervention is an operation used to unblock narrowed coronary arteries (blood vessels in the heart).
Efient- behandlingen indledes med én dosis på 60 mg.
Efient treatment starts with one 60-mg dose.
Lægemidlet kan tages sammen med et måltid eller mellem måltiderne.
The medicine can be taken with or without food.
Patienter, der tager Efient, skal også tage den dosis aspirin, lægen har ordineret.
Patients taking Efient should also take aspirin at a dose prescribed by their doctors.
Efient anbefales ikke til patienter under 18 år, da der ikke foreligger oplysninger om dets sikkerhed og virkning i denne aldersgruppe.
The use of Efient in patients below 18 years of age is not recommended because of a lack of information on safety and effectiveness in this age group.
Lægemidlet anbefales heller ikke til patienter over 75 år, medmindre lægen har vurderet fordele og risici omhyggeligt og mener, at behandling med Efient er nødvendig.
Its use is also not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Efient as necessary.
Dette nedsætter risikoen for, at der dannes en blodprop, og er med til at forebygge hjerteanfald og slagtilfælde.
This stops the platelets becoming ‘ sticky’, reducing the risk of a blood clot forming and helping to prevent a heart attack or a stroke.
Virkningerne af Efient blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Efient were first tested in experimental models before being studied in humans.
I en af hovedundersøgelserne blev Efient sammenlignet med clopidogrel (der også hæmmer aggregering af blodplader).
In one main study Efient, given as a 60-mg starting dose followed by 10-mg ‘ maintenance’ doses, was compared with clopidogrel (another inhibitor of platelet aggregation), both medicines taken in combination with aspirin.
Efient blev givet med en startdosis på 60 mg efterfulgt af "vedligeholdelsesdoser" på 10 mg, og begge lægemidler blev taget sammen med aspirin.
The study involved almost 14,000 adults with acute coronary syndrome who were about to undergo percutaneous coronary intervention.
Patienterne blev fulgt i gennemsnitligt 14, 5 måneder.
The patients were followed up for an average of 14.5 months.
Ved afslutningen af undersøgelsen var 9% af de patienter, der havde taget Efient, døde af kardiovaskulære årsager eller havde haft hjerteanfald eller slagtilfælde (643 ud af 6. 813) sammenlignet med 11% af de patienter, der havde taget clopidogrel (781 ud af 6. 795).
At the end of the study, 9% of the patients taking Efient had died from cardiovascular causes or had a heart attack or stroke (643 out of 6,813) compared with 11% of the patients taking clopidogrel (781 out of 6,795).
Den fuldstændige liste over alle de indberettede bivirkninger ved Efient fremgår af indlægssedlen.
For the full list of all side effects reported with Efient, see the Package Leaflet.
Efient bør ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for prasugrel eller andre af indholdsstofferne.
Efient should not be used in people who may be hypersensitive (allergic) to prasugrel or any of the other ingredients.
Det må ikke anvendes af patienter med lidelser, der forårsager kraftig blødning, eller af patienter, som har haft et slagtilfælde eller forbigående iskæmisk anfald (en midlertidig reduktion af blodforsyningen til en del af hjernen), eller som lider af alvorlige leverproblemer.
It must not be used in patients who have a condition that causes excessive bleeding, who have had a stroke or transient ischaemic attack (a temporary reduction in the blood supply to part of the brain), or with severe liver problems.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Efient er større end risiciene, når det tages sammen med aspirin for at forhindre aterotrombotiske hændelser hos patienter med akut koronarsyndrom, der gennemgår primær eller forsinket perkutan koronarintervention.
The Committee for Medicinal Products for Human Use (CHMP) decided that Efient’ s benefits are greater than its risks, when co-administered with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Efient?
Which measures are being taken to ensure the safe use of Efient?
Virksomheden, som fremstiller Efient, vil sørge for, at der i alle medlemsstater udleveres undervisningsmaterialer til alle læger, som behandler patienter med lægemidlet.
The company that makes Efient will make sure that educational materials are available in all Member States for doctors who will treat patients with the medicine.
Andre oplysninger om Efient:
Other information about Efient:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Efient til Eli Lilly Nederland BV den 25. februar 2009.
The European Commission granted a marketing authorisation valid throughout the European Union for Efient to Eli Lilly Nederland BV on 25 February 2009.
Den fuldstændige EPAR for Efient findes her.
The full EPAR for Efient can be found here.
Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
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blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu)
14 tabletter 28 tabletter 30 x 1 tablet 56 tabletter 84 tabletter 90 x 1 tablet 98 tabletter 14 tabletter 28 tabletter 30 x 1 tablet 56 tabletter 84 tabletter 90 x 1 tablet 98 tabletter
14 tablets 28 tablets 30 x 1 tablet 56 tablets 84 tablets 90 x 1 tablet 98 tablets 14 tablets 28 tablets 30 x 1 tablet 56 tablets 84 tablets 90 x 1 tablet 98 tablets
PRODUKTRESUME 1.
SUMMARY OF PRODUCT CHARACTERISTICS
Hver tablet indeholder 2, 7 mg lactose.
Each tablet contains 2.7 mg lactose.
Gule tabletter med form som en aflang sekskant, præget med ” 5 mg ” på den ene side og ” 4760 ” på den anden.
Yellow and double-arrow-shaped tablets, debossed with “ 5 mg” on one side and “ 4760” on the other.
Efient er i kombination med acetylsalicylsyre (ASA) indiceret til forebyggelse af aterotrombotiske hændelser hos patienter med akut koronarsyndrom (dvs. ustabil angina, myokardieinfarkt uden elevation af ST- segment [UA/ NSTEMI] eller myokardieinfarkt [STEMI] med ST- segment elevation, som gennemgår primær eller forsinket perkutan koronarintervention (PCI).
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i. e. unstable angina, non-ST segment elevation myocardial infarction [UA/ NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Voksne Behandling med Efient bør initieres med en enkelt 60 mg stabiliseringsdosis og derpå fortsættes med 10 mg én gang daglig.
Adults Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day.
Hos patienter med akut koronarsyndrom (AKS), som gennemgår PCI, kan for tidlig seponering af enhver trombocytfunktionshæmmer inklusive Efient, resultere i en øget risiko for trombose, myokardieinfarkt eller død som følge af patientens tilgrundliggende sygdom.
In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Efient, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient’ s underlying disease.
4. 4 og 5. 1).
A treatment of up to 12 months is recommended unless the discontinuation of Efient is clinically indicated (see sections 4.4 and 5.1).
Patienter ≥ 75 år Efient bør normalt ikke anvendes til patienter ≥ 75 år.
Patients ≥ 75 years old The use of Efient in patients ≥ 75 years of age is generally not recommended.
4. 4),, bør det ordineres som en stabiliseringsdosis på 60 mg efterfulgt af en lavere vedligeholdelsesdosis på 5 mg.
If, after a careful individual benefit/ risk evaluation by the prescribing physician (see section 4.4), treatment is deemed necessary in the patients age group ≥ 75 years, then following a 60 mg loading dose a reduced maintenance dose of 5 mg should be prescribed.
4. 4, 4. 8, 5. 1 og 5. 2).
Patients ≥ 75 years of age have greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel (see sections 4.4, 4.8, 5.1 and 5.2).
Evidensen for en dosis på 5 mg er kun baseret på farmakodynamiske/ farmakokinetiske analyser, og der er ingen tilgængelige kliniske data vedrørende sikkerheden for denne dosis i patientgrupper ≥ 75 år.
The evidence for the 5 mg dose is based only on pharmacodynamic/ pharmacokinetic analyses and no clinical data currently exist on the safety of this dose in the patients age group ≥ 75 years.
Patienter med vægt < 60 kg Efient bør gives som en enkelt 60 mg stabiliseringsdosis og derpå fortsættes med en dosis på 5 mg én gang daglig.
Patients weighing < 60 kg Efient should be given as a single 60 mg loading dose and then continued at a 5 mg once daily dose.
10 mg som vedligeholdelsesdosis bør ikke anvendes.
2 The 10 mg maintenance dose is not recommended.
2 legemsvægt < 60 kg, når der gives en dosis på 10 mg én gang daglig sammenlignet med patienter ≥ 60 kg.
This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight < 60 kg when given a 10 mg once daily dose compared with patients ≥ 60 kg.
4. 4, 4. 8 og 5. 2).
Efficacy and safety of the 5 mg dose have not been prospectively assessed (see sections 4.4, 4.8 and 5.2).
5. 2).
Renal impairment No dose adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (see section 5.2).
4. 4).
There is limited therapeutic experience in patients with renal impairment (see section 4.4).
Nedsat leverfunktion Der er ikke nødvendigt at justere dosis hos patienter med mild til moderat nedsat leverfunktion (Child Pugh- klasse A og B) (se pkt.
Hepatic impairment No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh class A and B) (see section 5.2).
4. 4).
There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4).
Børn og unge Efient bør ikke anvendes til børn under 18 år p. g. a. manglende data for sikkerhed og virkning.
Children and adolescents Efient is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
Administrationsmåde Til oral anvendelse.
Method of administration For oral use.
5. 2).
Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2).
Svært nedsat leverfunktion (Child Pugh- klasse C).
Severe hepatic impairment (Child Pugh class C).
Blødningsrisiko I det kliniske fase 3- forsøg omfattede hovedeksklusionskriterierne en øget risiko for blødning, anæmi, trombocytopeni og tidligere patologiske intrakranielle fund.
Bleeding risk In the phase 3 clinical trial key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings.
De patienter med akut koronarsyndrom, som gennemgik PCI og blev behandlet med Efient og ASA, viste en øget risiko for større og mindre blødning i henhold til TIMI- klassifikationssystemet.
Patients with acute coronary syndromes undergoing PCI treated with Efient and ASA showed an increased risk of major and minor bleeding according to the TIMI classification system.
Denne overvejelse vedrører især følgende patienter: • ≥ 75 år (se nedenunder). • med en tendens til at bløde (f. eks. på grund af nyligt traume, nylig kirurgi, nylig eller tilbagevendende gastrointestinal blødning eller aktiv mavesårssygdom). • med legemsvægt < 60 kg (se pkt.
This concern applies especially to patients: • ≥ 75 years of age (see below). • with a propensity to bleed (e. g. due to recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, or active peptic ulcer disease) • with body weight < 60 kg (see sections 4.2 and 4.8).
4. 2 og 4. 8).
In these patients the 10 mg maintenance dose is not recommended.
10 mg vedligeholdelsesdosis frarådes til disse patienter.
A 5 mg maintenance dose should be used. • with concomitant administration of medicinal products that may increase the risk of bleeding, including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.
Det kan blive nødvendigt med transfusion af blodplader til patienter med aktiv blødning.
For patients with active bleeding for whom reversal of the pharmacological effects of Efient is required, platelet transfusion may be appropriate.
I det kliniske fase 3- forsøg havde disse patienter større risiko for blødning, herunder fatal blødning, sammenlignet med patienter < 75 år.
The use of Efient in patients ≥ 75 years of age is generally not recommended and should only be undertaken with caution after a careful individual benefit/ risk evaluation by the prescribing physician indicates that benefits in terms of prevention of ischaemic events outweigh the risk of serious bleedings.
Hvis det ordineres, bør der anvendes en mindre vedligeholdelsesdosis på 5 mg.
In the phase 3 clinical trial these patients were at greater risk of bleeding, including fatal 3 bleeding, compared to patients < 75 years of age.
4. 2 og 4. 8).
If prescribed, a lower maintenance dose of 5 mg should be used; the 10 mg maintenance dose is not recommended (see sections 4.2 and 4.8).
Disse
Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) and in patients with moderate hepatic impairment.
3 patienter har muligvis øget blødningsrisiko.
These patients may have an increased bleeding risk.
Den terapeutiske erfaring med prasugrel til asiatiske patienter er begrænset.
Therapeutic experience with prasugrel is limited in Asian patients.
Kirurgi Patienterne bør rådes til at informere læger og tandlæger om, at de tager prasugrel, før nogen form for kirurgi planlægges, og før noget nyt lægemiddel tages.
Surgery Patients should be advised to inform physicians and dentists that they are taking prasugrel before any surgery is scheduled and before any new medicinal product is taken.
4. 8), kan der forekomme øget hyppighed og sværhed af blødning.
Increased frequency (3-fold) and severity of bleeding may occur in patients undergoing CABG surgery within 7 days of discontinuation of prasugrel (see 4.8).
Trombotisk trombocytopenisk purpura (TTP) Der er indberettet TTP ved brug af andre thienopyridiner.
Thrombotic Thrombocytopaenic Purpura (TTP) TTP has been reported with the use of other thienopyridines.
Efient blev ikke associeret med TTP i de kliniske forsøg, som ligger til grund for godkendelsen af lægemidlet.
Efient was not associated with TTP in clinical trials supporting registration.
Lactose Efient bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactose malabsorption.
Lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take Efient.
På grund af muligheden for øget blødningsrisiko bør kombinationen warfarin (eller andre kumarinderivater) og prasugrel administreres med forsigtighed (se pkt 4. 4).
Because of the potential for increased risk of bleeding, warfarin (or other coumarin derivatives) and prasugrel should be co-administered with caution (see section 4.4).
Non- steroide antiinflammatoriske midler (NSAIDs):
Non-steroidal anti-inflammatory drugs (NSAIDs):
4. 4).
Because of the potential for increased risk of bleeding, chronic NSAIDs (including COX-2 inhibitors) and Efient should be co-administered with caution (see section 4.4).