natgillin/translations-raw huggingface dataset:
Gastrointestinal Mavesår og blødning, diarré, duodenalt mavesmerter, ulcus gastritis, dyspepsi opkastning, kvalme, forstoppelse, flatulens
Retroperitoneal Gastrointestinal and
Retroperitoneal blødning
haemorrhage, diarrhoea, abdominal pain, dyspepsia
Hud og subkutane væv Blå mærker
Skin and subcutaneous tissue disorders
Almene symptomer og Blødning ved reaktioner på injektionssteder administrationsstedet
General disorders and administration site conditions
Clopidogrel hæmmer selektivt at adenosindiphosphat (ADP) bindes til dets trombocytreceptor, og som følge deraf, at ADP aktiverer GBIIb- IIIa- komplekset, og derved hæmmer clopidogrel trombocytaggregationen.
Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor, and the subsequent ADP-mediated activation of the GPIIb/IIIa complex, thereby inhibiting platelet aggregation.
Derfor påvirkes trombocytter, der har været udsat for clopidogrel, i resten af deres levetid, og den normale trombocytfunktion generhverves med den hastighed hvormed trombocytterne omsættes.
Consequently, platelets exposed to clopidogrel are affected for the remainder of their lifespan and recovery of normal platelet function occurs at a rate consistent with platelet turnover.
Ved steady state var den hæmningsgrad der blev iagttaget med en dosis på 75 mg/ dag mellem 40% og 60%.
At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
Sikkerheden og effekten af clopidrogrel er blevet evalueret i 4 dobbeltblindede forsøg, der omfattede mere end 80. 000 patienter, CAPRIE- undersøgelsen, hvor clopidogrel sammenlignes med ASA, og CURE, CLARITY og COMMIT- undersøgelserne, hvor clopidogrel sammenlignes med placebo, og hvor begge lægemidler gives i kombination med ASA eller anden standardterapi.
The safety and efficacy of clopidogrel have been evaluated in 4 double-blind studies involving over 80,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY and COMMIT studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Patienterne blev randomiseret til clopidogrel 75 mg/ dag eller ASA 325 mg/ dag og blev kontrolleret i 1- 3 år.
Patients were randomised to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
0, 2- 16, 4], p=0, 045), hvilket, for hver 1000 patienter der blev behandlet i 2 år, svarer til, at yderligere 10 [CI:
0.2 to 16.4]; p = 0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI:
Patienterne blev randomiseret til clopidogrel (300 mg initial stabiliseringsdosis efterfulgt af 75 mg/ dag, N=6. 259) eller placebo (N=6. 303), begge i kombination med ASA (75- 325 mg en gang daglig) samt anden standard - behandling.
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.
I CURE blev 823 (6, 6%) patienter samtidig behandlet med GPIIb/ IIIa- hæmmere.
In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
10% - 28%; p=0, 00009) for clopidogrelgruppen (en 17% relativ risikoreduktion, når patienterne fik konservativ behandling, 29% når de fik perkutan transluminal koronar angioplasti (PTCA) med eller uden stent, og 10% når de fik koronar bypassoperation (CABG)).
19 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)).
24, 3%, 57, 5%) og GPIIb/ IIIa- hæmmere (RRR = 18, 2%, CI:
24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR = 18.2%; 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.
De resultater, som blev opnået i populationer med forskellige karakteristika (fx ustabil angina pectoris eller myokardieinfarkt uden forekomst af Q- takker, høj - eller lavrisikogruppe, diabetes, behov for revaskularisering, alder, køn, osv.) svarede til den primære analyses resultater.
The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Specielt i en post- hoc analyse af 2172 patienter som fik indsat stent (17% af den totale population i CURE- studiet, Stent- CURE), viste data, at clopidogrel sammenlignet med placebo medførte en signifikant RRR på 26, 2%, med hensyn til primære endepunkter (CV død, MI, hjerteanfald) og desuden en signifikant RRR på 23, 9% med hensyn til det andet primære endepunkt (CV død, MI, hjerteanfald eller refraktær iskæmi).
In particular, in a post-hoc analysis in 2,172 patients (17% of the total CURE population) who underwent stent placement (Stent-CURE), the data showed that clopidogrel compared to placebo, demonstrated a significant RRR of 26.2% favouring clopidogrel for the co-primary endpoint (CV death, MI, stroke) and also a significant RRR of 23.9% for the second co-primary endpoint (CV death, MI, stroke or refractory ischaemia).
De fordele, der blev observeret for clopidogrel, var uafhængige af anden akut og langvarig behandling af kardiovaskulære sygdomme (med fx heparin/ LMWH, GPIIb/ IIIa- hæmmere, lipidsænkende lægemidler, beta - blokkere og ACE- hæmmere).
The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
CLARITY- studiet inkluderede 3491 patienter, der var til rådighed inden for 12 timer efter, at et MI med elevation af ST- segmentet var indtrådt, og som det var planlagt at give en trombolytisk behandling.
The CLARITY trial included 3,491 patients presenting within 12 hours of the onset of a ST elevation MI and planned for thrombolytic therapy.
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 dagligt), et fibrinolytisk middel samt heparin, når det var hensigtsmæssigt.
Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), 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.
Patientpopulationen bestod af 19, 7% kvinder og 29, 2% af patienter var over 65 år.
The patient population included 19.7% women and 29.2% patients ≥ 65 years.
En total på 99, 7% af patienterne fik fibrinolytika (fibrin specifik:
A total of 99.7% of patients received fibrinolytics (fibrin specific:
Femten procent (15, 0%) af patienterne i clopidogrel- gruppen og 21, 7% i placebogruppen opnåede det primære endepunkt, hvilket viste en absolut reduktion på 6, 7% og en odds reduktion på 36% til fordel for clopidogrel (95% CI:
Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36% odds reduction in favor of clopidogrel (95% CI:
24, 47%; p < 0. 001), der hovedsagligt var relateret til en reduktion af infarkt- relaterede okkluderede arterier.
24, 47%; p < 0.001), mainly related to a reduction in occluded infarct-related arteries.
Det COMMIT- studie, som var designet med 2x2 faktor inkluderede 45852 patienter, der var til rådighed inden for 24 timer efter der indtrådte symptomer som var mistænkt for at være MI, og hvor EKG- anomalier (dvs.
20 The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e.
ST- elevation, ST- depression eller venstresidig grenblok) understøttede dette.
ST elevation, ST depression or left bundle-branch block).
Patienterne fik clopidogrel (75mg/ dag, n=22961) eller placebo (n=22891), i kombination med ASA (162 mg/ dag) i 28 dage eller indtil udskrivelse fra hospitalet.
Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
Plasmakoncentrationerne af udgangsstoffet er imidlertid meget lave (< 0, 00025 mg) og kan ikke detekteres 2 timer efter dosering.
However, plasma concentrations of the parent compound are very low and below the quantification limit (0.00025 mg/l) beyond 2 hours.
Clopidogrel bliver i udstrakt grad omdannet i leveren, og den inaktive hovedmetabolit er carboxylsyrederivatet, som udgør ca.
Clopidogrel is extensively metabolised by the liver and the main metabolite, which is inactive, is the carboxylic acid derivative, which represents about 85% of the circulating compound in plasma.
85% af det cirkulerende stof i plasma.
Peak plasma levels of this metabolite (approx.
1 time efter dosering.
3mg/l after repeated 75 mg oral doses) occurred approximately 1 hour after dosing.
Halveringstiden for elimination af den cirkulerende hovedmetabolit var 8 timer efter en enkelt og efter gentagen administration.
The elimination half-life of the main circulating metabolite was 8 hours after single and repeated administration.
Efter gentagen dosering med clopidogrel 75 mg/ dag var plasmaniveauet for den cirkulerende hovedmetabolit lavere hos forsøgspersoner med alvorlig nyresygdom (kreatininclearance 5- 15 ml/ min) sammenlignet med forsøgspersoner med moderat nyresygdom (kreatininclearance 30- 60 ml/ min) og niveauet i andre undersøgelser hos raske forsøgspersoner.
After repeated doses of 75 mg clopidogrel per day, plasma levels of the main circulating metabolite were lower in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min) compared to subjects with moderate renal disease (creatinine clearance from 30 to 60 ml/min) and to levels observed in other studies with healthy subjects.
Daglig dosering i 10 dage med clopidogrel 75 mg/ dag var sikker og veltolereret.
Daily dosing for 10 days with clopidogrel 75 mg/day was safe and well tolerated.
Alligevel var plasmaniveauet af den cirkulerende hovedmetabolit sammen med effekten af clopidogrel på den trombocytaggregation som ADP inducerer og kapillærblødningstiden sammenlignelig mellem de to grupper.
However, plasma levels of the main circulating metabolite together with the effect of clopidogrel on ADP-induced platelet aggregation and bleeding time were comparable between these groups.
5. 3 Prækliniske sikkerhedsdata
21 5.3 Preclinical safety data
De optrådte ved doser, der var mindst 25 gange højere end de kliniske doser på 75 mg/ dag til mennesker, og var en konsekvens af effekten på levermetaboliseringsenzymerne.
These occurred at doses representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day and were a consequence of an effect on hepatic metabolising enzymes.
Ved meget høje doser clopidogrel blev der hos rotter og bavianer observeret dårlig gastrisk tolerans (gastritis, gastriske erosioner og/ eller opkastning).
At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of clopidogrel was also reported in rat and baboon.
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 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Mannitol (E421) Macrogol 6000 Mikrokrystallinsk cellulose Hydrogeneret ricinusolie Hydroxypropylcellulose, lavsubstitueret
Mannitol (E421) Macrogol 6000 Microcrystalline cellulose Hydrogenated castor oil Low substituted hydroxypropylcellulose
6. 3 Opbevaringstid
6. 3 Shelf-life
6. 5 Emballage (art og indhold)
22 6.5 Nature and content of container
Perforerede dosisblistere af PVC/ PVDC/ aluminium eller aluminium i kartonæsker der indeholder 4x1, 30x1 og 100x1 filmovertrukne tabletter.
Aluminium perforated unit-dose blisters in cardboard cartons containing 4x1, 30x1 and 100x1 film-coated tablets.
EU/ 1/ 08/ 464/ 015 – Kartoner med 4x1 filmovertrukne tabletter i aluminium perforerede dosisblister EU/ 1/ 08/ 464/ 016 – Kartoner med 30x1 filmovertrukne tabletter i aluminium perforerede dosisblister EU/ 1/ 08/ 464/ 017 – Kartoner med 100x1 filmovertrukne tabletter i aluminium perforerede dosisblister
EU/1/08/464/015 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/464/016 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/464/017 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters
16. juli 2008 10.
16 July 2008
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside: http: // www. emea. europa. eu BILAG II
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN A.
CONDITIONS OF THE MARKETING AUTHORISATION
- Clopidogrel BMS 75 mg filmovertrukne tabletter
- Clopidogrel BMS 75 mg film-coated tablets
Sanofi Winthrop Industrie 1, Rue de la Vierge Ambarès & Lagrave F- 33565 Carbon Blanc cedex Frankrig
Sanofi Winthrop Industrie 1, route de la vierge, Ambarès & Lagrave F-33565 Carbon Blanc Cedex France
Sanofi Synthelabo Limited Edgefield Avenue Fawdon Newcastle upon Tyne NE3 3TT Storbritannien
Sanofi-Synthelabo Limited Edgefield avenue, Fawdon, Newcastle-Upon-Tyne, Tyne & Wear NE3 3TT United Kingdom
Sanofi Winthrop Industrie 6, Boulevard de l’ Europe F- 21800 Quétigny Frankrig
Sanofi Winthrop Industrie 6, boulevard de l'Europe F-21800 Quétigny France
- Clopidogrel BMS 300 mg filmovertrukne tabletter
- Clopidogrel BMS 300 mg film-coated tablets
Sanofi Winthrop Industrie 1, Rue de la Vierge Ambarès & Lagrave F- 33565 Carbon Blanc cedex Frankrig
Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc cedex France
• ANDRE BETINGELSER System til registrering af bivirkninger
• OTHER CONDITIONS
Indehaveren af markedsføringstilladelsen skal sikre, at det system til registrering af bivirknnger som er beskrevet i version 2. 0 dateret 25. september 2007 og præsenteret i Modul 1. 8. 1. til Ansøgning om Markedsføringstilladelse, er til stede og fungerer før og under markedsføring af produktet.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
BILAG III
25 ANNEX III
ETIKETTERING OG INDLÆGSSEDDEL A.
LABELLING AND PACKAGE LEAFLET
ETIKETTERING OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Pakning med 7, 14, 28, 30, 50x1, 84, 90 eller 100 tabletter
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 7, 14, 28, 30, 50x1, 84, 90 or 100 tablets
28 filmovertrukne tabletter 30 film- coated tablets 50x1 filmovertrukne tabletter 84 filmovertrukne tabletter 100 filmovertrukne tabletter 30 filmovertrukne tabletter 90 filmovertrukne tabletter 14 filmovertrukne tabletter 7 filmovertrukne tabletter
14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50x1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets 7 film-coated tablets
UDLØBSDATO EXP {MM/ ÅÅÅÅ}
EXPIRY DATE
Opbevares under 30ºC (for PVC/ PVDC/ aluminium blister) Eller ingen særlige opbevaringsbetingelser (for blisterkort i ren aluminium)
Store below 30°C (for PVC/PVDC/aluminium blisters) Or No special storage conditions (for all aluminium blisters)
EU/ 1/ 08/ 464/ 001 14 tabletter EU/ 1/ 08/ 464/ 002 14 tabletter EU/ 1/ 08/ 464/ 003 28 tabletter EU/ 1/ 08/ 464/ 004 28 tabletter EU/ 1/ 08/ 464/ 005 30 tabletter EU/ 1/ 08/ 464/ 006 30 tabletter EU/ 1/ 08/ 464/ 007 50x1 tabletter EU/ 1/ 08/ 464/ 008 50x1 tabletter EU/ 1/ 08/ 464/ 009 84 tabletter EU/ 1/ 08/ 464/ 010 84 tabletter EU/ 1/ 08/ 464/ 011 90 tabletter EU/ 1/ 08/ 464/ 012 90 tabletter EU/ 1/ 08/ 464/ 013 100 tabletter EU/ 1/ 08/ 464/ 014 100 tabletter
EU/1/08/464/001 14 tablets EU/1/08/464/002 14 tablets EU/1/08/464/003 28 tablets EU/1/08/464/004 28 tablets EU/1/08/464/005 30 tablets EU/1/08/464/006 30 tablets EU/1/08/464/007 50x1 tablets EU/1/08/464/008 50x1 tablets EU/1/08/464/009 84 tablets EU/1/08/464/010 84 tablets EU/1/08/464/011 90 tablets EU/1/08/464/012 90 tablets EU/1/08/464/013 100 tablets EU/1/08/464/014 100 tablets EU/1/08/464/018 7 tablets EU/1/08/464/019 7 tablets
Lot:
Batch number:
Clopidogrel BMS 75 mg MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT
29 Clopidogrel BMS 75 mg
(pakningermed 14, 28 eller 84 tabletter)
30 PARTICULARS TO APPEAR ON BLISTERS (boxes of 7, 14, 28 or 84 tablets)
Bristol- Myers Squibb Pharma EEIG
Bristol Myers Squibb Pharma EEIG
Lot:
Batch number
Kalenderdage Ma Ti On To Fr Lø Sø
Calendar days Mon Tue Wed Thu Fri Sat Sun
Uge 1 Uge 2 Kun for pakninger med 7, 28 og 84 tabletter Uge 3 Kun for pakninger med 28 og 84 tabletter Uge 4 Kun for pakninger med 28 og 84 tabletter MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT (pakning med 30, 50x1, 90 eller 100 tabletter)
Week 1 Week 2 (for boxes of 14, 28 and 84 tablets) Week 3 (for boxes of 28 and 84 tablets) Week 4 (for boxes of 28 and 84 tablets)
ANDET MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Pakning med 4x1, 30x1 eller 100x1 filmovertrukne tabletter
OUTER CARTON/Box of 4x1, 30x1 or 100x1 tablets
300 mg clopidogrel (som hydrogensulfat)
Each tablet contains 300 mg of clopidogrel (as hydrogen sulphate)
Bristol Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Storbritannien
Bristol Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
EU/ 1/ 08/ 464/ 015 4x 1tabletter EU/ 1/ 08/ 464/ 016 30x1 tabletter EU/ 1/ 08/ 464/ 017 100x1 tabletter
EU/1/08/464/015 4x1 film-coated tablets EU/1/08/464/016 30x1 film-coated tablets EU/1/08/464/017 100x1 film-coated tablets
Clopidogrel BMS 300 mg MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT
Clopidogrel BMS 300 mg
BLISTER / Pakning med 4x1, 30x1 eller 100x1 tabletter)
BLISTER /Box of 4x1, 30x1 or 100x1 tablets
ANDET B.
OTHER
INDLÆGSSEDDEL INDLÆGSSEDDEL:
PACKAGE LEAFLET
- Spørg lægen eller på apoteket, hvis der er mere De vil vide.
- If you have any further questions, ask your doctor or your pharmacist.
- Lægen har ordineret Clopidogrel BMS til Dem personligt.
- This medicine has been prescribed for you.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
nævnt her..
please tell your doctor or pharmacist.
Clopidogrel BMS’ s virkning, og hvad De skal bruge det til 2.
What Clopidogrel BMS is and what it is used for 2.
Det skal De vide, før De begynder at tage Clopidogrel BMS 3.
Before you take Clopidogrel BMS 3.
Bivirkninger 5.
How to take Clopidogrel BMS 4.
Sådan opbevarer De Clopidogrel BMS 6.
Possible side effects 5 How to store Clopidogrel BMS 6.
CLOPIDOGREL BMS’ S VIRKNING, OG HVAD DE SKAL BRUGE DET TIL
WHAT CLOPIDOGREL BMS IS AND WHAT IT IS USED FOR
Clopidogrel BMS tages 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. slagtilfælde, hjerteanfald og død (aterotrombotiske hændelser).
Clopidogrel BMS is taken 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).
- De lider af åreforkalkning (også kaldet aterosklerose) - og
- You have a condition of hardening of arteries (also known as atherosclerosis), and
- De tidligere har haft et hjerteanfald, slagtilfælde eller kredsløbsforstyrrelser i arme eller ben - eller
- You have previously experienced a heart attack, stroke or have a condition known as peripheral
- De har haft en alvorlig form for smerter i brystet, som kaldes hjertekrampe (ustabil angina pectoris) eller
- You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial
hjerteanfald (myokardieinfarkt).
infarction’ (heart attack).
DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE CLOPIDOGREL BMS
BEFORE YOU TAKE CLOPIDOGREL BMS
Tag ikke Clopidogrel BMS: • Hvis De er overfølsom (allergisk) over for clopidogrel eller et af de øvrige indholdsstoffer i Clopidogrel BMS. • Hvis De har en aktiv blødning såsom et mavesår eller en blødning i hjernen; • Hvis De lider af alvorlig leversygdom Hvis De mener, at ovenstående gælder for Dem, eller hvis De overhovedet er i tvivl, så rådfør Dem med Deres læge, inden De tager Clopidogrel BMS.
• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel BMS; • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain; • If you suffer from severe liver disease.
Vær ekstra forsigtig med at bruge Clopidogrel BMS:
37 Take special care with Clopidogrel BMS:
Hvis nogen af følgende situationer gælder for Dem, skal De oplyse det til Deres læge, før De tager Clopidogrel BMS: • De har risiko for blødninger f. eks. på grund af:
If any of the situations mentioned below apply to you, you should tell your doctor before taking clopidogrel: • if you have a risk of bleeding such as
- en medicinsk lidelse, der medfører risiko for indre blødninger (såsom et mavesår)
- a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer)
- en blødningslidelse, der giver Dem tendens til indre blødning (blødning inde i et af kroppens væv,
a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
organer eller led)
- - -
- en nylig alvorlig kvæstelse
a recent serious injury a recent surgery (including dental) a planned surgery (including dental) in the next seven days
- et nyligt kirurgisk indgreb (gælder også tandoperationer)
if
- et planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage
you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the
• hvis De har haft en blodprop i en åre (arterie) i hjernen (iskæmisk slagtilfælde), inden for de seneste 7 dage • De får en anden slags medicin (se Anvendelse af andre lægemidler) • De lider af en nyre - eller leversygdom
last seven days • if you are taking another type of medicine (see ‘Taking other medicines’). • if you have kidney or liver disease