FrancophonIA/ELRC3.0 huggingface dataset:
English: What Prasugrel Mylan contains - The active substance is prasugrel.
Danish: Prasugrel Mylan indeholder - Aktivt stof: prasugrel.
English: Prasugrel Mylan should be given as a single 60 mg loading dose and then continued at a 5 mg once daily dose.
Danish: Prasugrel Mylan bør gives som en enkelt 60 mg støddosis og derpå fortsættes med en dosis på 5 mg én gang daglig.
English: * TRITON study in ACS patients undergoing PCI ** TRILOGY-ACS study in patients not undergoing PCI (see 5.1): a 10 mg prasugrel; 5 mg prasugrel if ≥75 years of age
Danish: * TRITON-studiet, hvor AKS-patienterne gennemgik PCI ** TRILOGY-AKS-studiet, hvor patienterne ikke gennemgik PCI (se 5.1): a 10 mg prasugrel; 5 mg prasugrel hvis ≥ 75 år
English: Pharmacokinetic in special populations
Danish: Farmakodynamik hos Særlige Grupper
English: Crospovidone Colloidal anhydrous silica Magnesium stearate
Danish: Silica, kolloid vandfri Magnesiumstearat
English: Prasugrel Mylan 5 mg: microcrystalline cellulose, mannitol, crospovidone, silica colloidal anhydrous, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), glyceryl monocaprylocaprate, sodium lauryl sulfate, iron oxide yellow (E172).
Danish: Prasugrel Mylan 5 mg: mikrokrystallinsk cellulose, mannitol, crospovidon, silica; kolloid vandfri, magnesiumstearat, polyvinylalkohol, talum, titandioxid (E171), glyceryl monocaprylocaprat, natriumlaurylsulfat, gul jernoxid (E172).
English: The higher risk for bleeding events in subjects treated with prasugrel persisted up to 7 days from the most recent dose of study drug.
Danish: Hos de forsøgspersoner, der blev behandlet med prasugrel, varede den højere risiko for blødningstilfælde i op til 7 dage efter den seneste dosis af forsøgsmedicin.
English: • Fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice).
Danish: • Feber og blå mærker eller røde nålespidslignende pletter, evt. med samtidig uforklarlig, voldsom træthed, forvirring og gulfarvning af hud og øjne (gulsot) (se pkt.
English: carton only:
Danish: kun på pakning:
English: Prasugrel 5 mg provided greater antiplatelet effect than clopidogrel 75 mg. Prasugrel should be used with caution in patients ≥75 years old and in patients weighing <60 kg (see sections 4.2, 4.4 and 4.8).
Danish: Prasugrel 5 mg gav en større antitrombotisk effekt end clopidogrel 75 mg. Prasugrel skal bruges med forsigtighed hos patienter ≥ 75 år og hos patienter, der vejer < 60 kg (se pkt.
English: * TRITON study in ACS patients undergoing PCI ** TRILOGY-ACS study in patients not undergoing PCI (see 5.1): a 10 mg prasugrel; 5 mg prasugrel if <60 kg
Danish: * TRITON-studiet, hvor AKS-patienterne gennemgik PCI ** TRILOGY-AKS-studiet, hvor patienterne ikke gennemgik PCI (se 5.1): a 10 mg prasugrel; 5 mg prasugrel hvis < 60 kg
English: • While you are taking Prasugrel Mylan:
Danish: • Mens du tager Prasugrel Mylan:
English: Your doctor should prescribe a daily dose of 5 mg as there is a greater risk of bleeding in patients older than 75 years - a recent serious injury - recent surgery (including some dental procedures) - recent or recurrent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon polyps) body weight of less than 60 kg.
Danish: Din læge bør ordinere en daglig dosis på 5 mg, da der er en større risiko for blødning hos patienter, der er ældre end 75 år, - du for nylig har haft en alvorlig kvæstelse, - du for nylig har fået foretaget et kirurgisk indgreb (herunder visse tandoperationer).
English: Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2).
Danish: Administration af 60 mg prasugrel støddosis ved faste kan give den hurtigst indsættende virkning (se pkt.
English: Your doctor should prescribe a daily dose of 5 mg of Prasugrel Mylan if you weigh less than 60 kg - renal (kidney) disease or moderate liver problems - taking certain types of medicines (see ‘Taking other medicines' below) - planned surgery (including some dental procedures) in the next seven days.
Danish: Mylan, hvis din vægt er under 60 kg, - du har en nyresygdom eller moderate leverproblemer, - du tager visse typer medicin (se ”Brug af anden medicin” nedenunder), - der er planlagt et kirurgisk indgreb (herunder visse tandoperationer) inden for de næste
English: Non-fatal MI
Danish: Ikke-letalt MI
English: • with body weight <60 kg (see sections 4.2 and 4.8).
Danish: • med legemsvægt < 60 kg (se pkt.
English: This medicine is available in plastic bottles containing a desiccant and 28 or 30 film-coated tablets and in blister packs containing 28, 30, 84, 90, 98 and in perforated blister packs containing 30 x 1 and 90 x 1 film-coated tablets.
Danish: Denne medicin er tilgængelig i plastbeholdere, der indeholder et tørremiddel og 28 eller 30 filmovertrukne tabletter, i blisterpakninger, der indeholder 28, 30, 84, 90, 98 tabletter, og i perforerede blisterpakninger, der indeholder 30x1 og 90x1 filmovertrukne tabletter.
English: Requiring inotropes Requiring surgical intervention Requiring transfusion (≥4 units) TIMI minor bleedingf a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study
Danish: TIMI mindre blødningf a Hændelser, der er bedømt centralt og defineret efter Thrombolysis in Myocardial Infarction (TIMI)
English: 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).
Danish: På grund af muligheden for øget blødningsrisiko bør kombinationen warfarin (eller andre kumarinderivater) og prasugrel administreres med forsigtighed (se pkt.
English: Prasugrel Mylan, which contains the active substance prasugrel, belongs to a group of medicines called antiplatelet agents.
Danish: Prasugrel Mylan indeholder det aktive stof prasugrel og tilhører en medicingruppe, som kaldes blodfortyndende medicin.
English: In clinical pharmacology studies, after adjusting for body weight, the AUC of the active metabolite was approximately 19% higher in Chinese, Japanese, and Korean subjects compared to that of Caucasians, predominantly related to higher exposure in Asian subjects <60 kg.
Danish: I klinisk farmakologiske forsøg var AUC af den aktive metabolit efter justering for legemsvægt ca. 19 % højere hos kinesiske, japanske og koreanske forsøgspersoner sammenlignet med kaukasiere.
English: Contains sunset yellow FCF aluminium lake (E110).
Danish: Indeholder sunset yellow FCF aluminium lake (E110).
English: Gastrointestinal haemorrhage
Danish: Gastrointestina l blødning
English: 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Danish: 28 filmovertrukne tabletter 30 filmovertrukne tabletter 84 filmovertrukne tabletter 98 filmovertrukne tabletter
English: Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake (E110) and sodium Sunset yellow FCF aluminium lake is a colouring agent, which may cause allergic reactions.
Danish: Prasugrel Mylan 10 mg indeholder sunset yellow FCF aluminium lake (E110) og natrium Sunset yellow FCF aluminium lake er et azo-farvestoffer, som kan forårsage allergiske reaktioner.
English: Prasugrel Mylan 5 mg: Do not store above 30°C.
Danish: Prasugrel Mylan 5 mg: Må ikke opbevares ved temperaturer over 30 °C.
English: Prasugrel Mylan should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day.
Danish: Behandling med Prasugrel Mylan bør initieres med en enkelt 60 mg støddosis og derpå fortsættes med 10 mg én gang daglig.
English: - have a medical condition that is currently causing bleeding, such as bleeding from your stomach or intestines.
Danish: Fortæl det omgående til din læge, hvis det sker for dig, - har en sygdom, som kan forårsage blødning, f.eks. blødning fra din mave eller tarm,
English: Because of the potential for increased risk of bleeding, chronic NSAIDs (including COX-2 inhibitors) and Prasugrel Mylan should be co-administered with caution (see section 4.4).
Danish: På grund af muligheden for øget blødningsrisiko bør kombinationen af vedvarende behandling med NSAIDs (inklusive COX-2 hæmmere) og Prasugrel Mylan administreres med forsigtighed (se pkt.
English: (see section 2 ‘What you need to know before you take Prasugrel Mylan')
Danish: 2 ”Det skal du vide, før du begynder at tage Prasugrel Mylan”).
English: Injury, poisoning and procedural complications
Danish: Traumer forgiftninger og behandlingskomplikatione r
English: 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).
Danish: Patienter ≥75 år har større følsomhed over for blødning og højere eksponering for den aktive metabolit af prasugrel (se pkt.
English: Prasugrel Mylan 10 mg: Do not store above 25°C.
Danish: Prasugrel Mylan 10 mg: Må ikke opbevares ved temperaturer over 25 °C.
English: Although bleeding was increased with prasugrel, an analysis of the composite endpoint of death from any cause, nonfatal myocardial infarction, nonfatal stroke, and non-CABG-related TIMI major haemorrhage favoured prasugrel compared to clopidogrel (Hazard ratio, 0.87; 95% CI, 0.79 to 0.95; p=0.004).
Danish: I en analyse af det endepunkt, der kombinerer død uanset årsag, ikke-letalt myokardieinfarkt, ikke-letalt slagtilfælde og ikke-CABG-relateret TIMI større blødning gav prasugrel bedre resultater end clopidogrel (risikoforhold 0,87, 95 %, CI 0,79 til 0,95, p = 0.004), selvom der var øget blødning med prasugrel.
English: Following administration of 75 mg clopidogrel once daily for 10 days, 40 healthy subjects were switched to prasugrel 10 mg once daily with or without a loading dose of 60 mg.
Danish: Efter administration af 75 mg clopidogrel én gang dagligt i 10 dage, blev 40 raske forsøgspersoner skiftet til prasugrel 10 mg én gang dagligt med eller uden en støddosis på 60 mg. Der blev observeret den samme eller højere hæmning af trombocytaggregeringen med prasugrel.
English: (see sections 4.2, 4.8 and 5.1).
Danish: 4.2, 4.8 og 5.1).
English: This medicine is available in plastic bottles containing a desiccant and 28 or 30 film-coated tablets and in blister packs containing 28, 30, 84 or 98 film-coated tablets.
Danish: Denne medicin er tilgængelig i plastbeholdere, der indeholder et tørremiddel og 28 eller 30 filmovertrukne tabletter, og i blisterpakninger, der indeholder 28, 30, 84 eller 98 filmovertrukne tabletter.
English: Prasugrel Mylan 10 mg: microcrystalline cellulose, mannitol, crospovidone, silica colloidal anhydrous, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), glyceryl monocaprylocaprate, sodium lauryl sulfate, iron oxide yellow (E172), sunset yellow FCF aluminium lake (E110) (see section 2, ‘Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake'), iron oxide red (E172).
Danish: Prasugrel Mylan 10 mg: mikrokrystallinsk cellulose, mannitol, crospovidon, silica; kolloid vandfri, magnesiumstearat, polyvinylalkohol, talcum, titandioxid (E171), glyceryl monocaprylocaprat, natriumlaurylsulfat, gul jernoxid (E172), sunset yellow FCF aluminium lake (E110) (se pkt.
English: In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Prasugrel Mylan, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient's underlying disease.
Danish: Hos patienter med akut koronarsyndrom (AKS), som gennemgår PCI, kan for tidlig seponering af enhver trombocytfunktionshæmmer inklusive Prasugrel Mylan, resultere i en øget risiko for trombose,
English: HDPE bottle: Do not store above 25°C.
Danish: HDPE-beholder: Må ikke opbevares ved temperaturer over 25 °C.
English: The most common site of spontaneous bleeding was the gastrointestinal tract (1.7% rate with prasugrel and 1.3% rate with clopidogrel); the most frequent site of provoked bleeding was the arterial puncture site (1.3% rate with prasugrel and 1.2% with clopidogrel).
Danish: Det mest hyppige sted for provokeret blødning var det arterielle indstikssted (1,3 % med prasugrel og 1,2 % med clopidogrel).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Mylan S.A.S.
English: In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients <60 kg taking 5 mg prasugrel was 38% lower than in patients ≥60 kg taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was similar to 10 mg.
Danish: I et studie med patienter med stabil aterosklerose var det gennemsnitlige AUC for den aktive metabolit 38 % lavere hos patienter < 60 kg, som fik 5 mg prasugrel, end hos patienter ≥ 60 kg, som fik 10 mg prasugrel.
English: Safety in patients with acute coronary syndrome undergoing PCI was evaluated in one clopidogrel controlled study (TRITON) in which 6741 patients were treated with prasugrel (60 mg loading dose and 10 mg once daily maintenance dose) for a median of 14.5 months (5802 patients were treated for over 6 months; 4136 patients were treated for more than 1 year).
Danish: I forsøget blev 6741 patienter behandlet med prasugrel (60 mg støddosis og 10 mg én gang dagligt som vedligeholdelsesdosis) i gennemsnitlig 14,5 måneder (5802 patienter blev behandlet i mere end 6 måneder, 4136 patienter blev behandlet i mere end 1 år).
English: Mean steady-state inhibition of platelet aggregation was 74% and 69% respectively for 5 µM ADP and 20 µM ADP, and was achieved following 3 to 5 days of administration of the 10 mg prasugrel maintenance dose preceded by a 60 mg loading dose.
Danish: Den gennemsnitlige steady state-hæmning af trombocytaggregeringen var henholdsvis 74 % og 69 % for 5 µM og 20 µM ADP, og blev nået efter 3 til 5 dages administration af en vedligeholdelsesdosis på 10 mg prasugrel med en forudgående støddosis på 60 mg. Mere end 98 % af forsøgspersonerne havde ≥ 20 % hæmning af trombocytaggregering under vedligeholdelsesdosering.
English: If you forget to take Prasugrel Mylan
Danish: Hvis du har glemt at tage Prasugrel Mylan
English: Respiratory, thoracic and mediastinal disorders
Danish: Vaskulære sygdomme Blodansamling Luftveje, thorax og mediastinum
English: There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4).
Danish: Der er begrænset terapeutisk erfaring hos patienter med mild til moderat (se pkt.
English: Sunset yellow FCF aluminium lake (E110) [only Prasugrel Mylan 10 mg]
Danish: Sunset yellow FCF aluminium lake (E110) [kun Prasugrel Mylan 10 mg] Rød jernoxid (E172) [kun Prasugrel Mylan 10 mg]
English: Therefore, in UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should be given at the time of PCI.
Danish: Hos UA/NSTEMI-patienter, hvor koronarangiografi udføres indenfor 48 timer efter indlæggelse, skal støddosis først indgives på tidspunktet for PCI (se pkt.
English: An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Danish: 6), En allergisk reaktion kan kendes på hududslæt, kløe, hævelse af ansigtet, hævede læber eller stakåndethed.
English: In a 30-day study (ACCOAST) in 4033 patients with NSTEMI with elevated troponin who were scheduled for coronary angiography followed by PCI within 2 to 48 hours after randomization, subjects who received prasugrel 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI (n=2037) had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (n=1996).
Danish: I et 30-dages studie (ACCOAST) med 4.033 patienter, som havde NSTEMI med forhøjet troponin, og hvor koronarangiografi efterfulgt af PCI var planlagt indenfor 2 til 48 timer efter randomisering, havde de patienter, som fik en 30 mg støddosis gennemsnitligt 4 timer før koronarangiografi efterfulgt af en 30 mg støddosis på tidspunktet for PCI (n = 2.037), en øget risiko for non-CABG-blødning i forbindelse med indgrebet og ingen yderligere fordele sammenlignet med de patienter, som fik en 60 mg støddosis på tidspunktet for PCI (n = 1.996).
English: Table 2: Haemorrhagic and non-haemorrhagic adverse reactions
Danish: Tabel 2: Hæmoragiske og non-hæmoragiske bivirkninger
English: Primary Composite Outcome Events Cardiovascular (CV) death, non fatal MI, or non fatal stroke
Danish: Kardiovaskulær (CV) død, ikke-letal MI eller ikke letalt slagtilfælde
English: White opaque HDPE bottle closed with white opaque polypropylene screw cap and aluminium induction sealing liner wad.
Danish: Hvid uigennemsigtig beholder af højdensitets polyethylen (HDPE) med hvidt, uigennemsigtigt polypropylenlåg og induktionsforsegling af aluminium.
English: INFORMATION IN BRAILLE prasugrel Mylan 10 mg
Danish: INFORMATION I BRAILLESKRIFT prasugrel Mylan 10 mg
English: Bleeding risk associated with timing of loading dose in NSTEMI In a clinical trial of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, a prasugrel loading dose given on average 4 hours prior to coronary angiography increased the risk of major and minor periprocedural bleeding compared with a prasugrel loading dose at the time of PCI.
Danish: Blødningsrisiko forbundet med tidspunktet for støddosis for NSTEMI-patienter I et klinisk studie med NSTEMI-patienter (ACCOAST-studiet), hvor koronarangiografi var planlagt udført indenfor 2 til 48 timer efter randomisering, øgede indgivelse af en prasugrel-støddosis gennemsnitlig 4 timer før koronarangiografi risikoen for større eller mindre blødninger i forbindelse med indgrebet sammenlignet med indgivelse af prasugrel-støddosis på tidspunktet for PCI.
English: <75 years (N=7180)**
Danish: < 75 år (N = 7.180)**
English: <75 years (N=11672)*
Danish: < 75år (N = 11.672)*
English: In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients ≥75 years old taking 5 mg prasugrel was approximately half that in patients <65 years old taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was reduced but was noninferior compared to 10 mg.
Danish: I et studie med patienter med stabil aterosklerose var det gennemsnitlige AUC for den aktive metabolit omtrent halvt så stort hos patienter ≥ 75 år, der fik 5 mg prasugrel, som hos patienter < 65 år, der fik 10 mg prasugrel.
English: 9.0% (1.0% fatal)
Danish: 9,0 % (1,0 % dødelige)
English: Fatal
Danish: Dødelig
English: Thrombocytopaenia
Danish: Trombocytopen i
English: STEMI Primary Composite Outcome Events
Danish: Hændelser i det primære sammensatte endepunkt
English: Do not eat or remove the desiccant contained in the bottle Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Prasugrel must not be used in patients with severe hepatic impairment (see section 4.3).
Danish: Prasugrel må ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
English: It is rapidly hydrolysed in theintestine to a thiolactone, which is then converted to the active metabolite by a single step of cytochrome P450 metabolism, primarily by CYP3A4 and CYP2B6 and to a lesser extent by CYP2C9
Danish: Det hydrolyseres hurtigt i tarmen til en thiolacton, som et enkelt trin af cytokrom P450-metabolismen derpå omdanner til den aktive metabolit.
English: 2.0% (0.1% fatal)a
Danish: 2,0 % (0,1 % dødelige)a
English: b Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Danish: b Enhver intrakraniel blødning eller enhver klinisk åbenlys blødning, der er forbundet med et fald i hæmoglobin ≥ 5 g/dl.
English: Prasugrel Mylan 5 mg: Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Danish: Prasugrel Mylan 5 mg: Hver tablet indeholder prasugrelbesilat svarende til 5 mg prasugrel.
English: 10.1% (0% fatal)
Danish: 10,1 % (0 % dødelige)
English: TIMI Major bleedingb Life-threateningc Fatal
Danish: TIMI større blødningb Livstruendec
English: Prasugrel Mylan 10 mg: Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Danish: Prasugrel Mylan 10 mg: Hver tablet indeholder prasugrelbesilat svarende til 10 mg prasugrel.
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium perforated unit dose blister pack containing 30 x 1 or 90 x 1 film-coated tablets.
Danish: OPA/Aluminium/PE/Tørremiddel/PE- aluminiumsperforerede enkeltdosisblisterpakninger, der indeholder 30×1 eller 90×1 filmovertrukne tabletter.
English: - have ever had a stroke or a transient ischaemic attack (TIA).
Danish: - på et tidligere tidspunkt har haft et slagtilfælde eller et forbigående tilfælde af sammentrækning af blodårer (iskæmisk tilfælde/TIA), - lider af en alvorlig leversygdom.
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84, 90 or 98 filmcoated tablets.
Danish: OPA/Aluminium/PE/Tørremiddel/PE- aluminiumblisterpakninger, der indeholder 28, 30, 84, 90 eller 98 filmovertrukne tabletter.
English: Each tablet contains 0.016 mg of sunset yellow FCF aluminium lake (E110).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 0,016 mg Sunset yellow FCF aluminium lake (E110).
English: Bleeding risk associated with timing of loading dose in NSTEMI In a clinical study of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, patients given a 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (see sections 4.2 and 4.4).
Danish: Blødningsrisiko forbundet med tidspunktet for støddosis for NSTEMI-patienter I et klinisk studie med NSTEMI-patienter (ACCOAST-studiet), hvor koronarangiografi var planlagt udført indenfor 2 til 48 timer efter randomisering, havde de patienter, som fik en 30 mg støddosis gennemsnitlig 4 timer før koronarangiografi efterfulgt af en 30 mg støddosis på tidspunktet for PCI, en øget risiko for non-CABG blødning i forbindelse med indgrebet og ingen yderligere fordele sammenlignet med de patienter, som fik en 60 mg støddosis på tidspunktet for PCI (se pkt.
English: • warfarin (an anti-coagulant),
Danish: • warfarin (forhindrer blodet i at størkne)
English: Do not stop taking Prasugrel Mylan without consulting your doctor; if you stop taking Prasugrel Mylan too soon, your risk of a heart attack may be higher.
Danish: Hvis du stopper for tidligt med at tage Prasugrel Mylan, kan du have højere risiko for at få et hjerteanfald.
English: * ICH = intracranial haemorrhage.
Danish: * ICH = intrakraniel blødning.
English: d ICH = intracranial haemorrhage.
Danish: d ICH = intrakraniel blødning.
English: The mean exposure (AUC) of the active metabolite of prasugrel is approximately 30 to 40% higher in healthy subjects and patients with a body weight of <60 kg compared to those weighing ≥60 kg.
Danish: Den gennemsnitlige eksponering (AUC) af prasugrels aktive metabolit er ca. 30 til 40 % højere hos raske forsøgspersoner og patienter med en legemsvægt på < 60 kg sammenlignet med dem, som vejer ≥ 60 kg. Prasugrel bør anvendes med forsigtighed til patienter med legemsvægt < 60 kg på grund af den potentielle blødningsrisiko hos denne gruppe (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER CARTON OF 10 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERPANING MED 10 MG FILMOVERTRUKNE TABLETTER
English: e ICH = intracranial haemorrhage.
Danish: e ICH = intrakraniel blødning.
English: 2.2% (0.2% fatal)a
Danish: 2,2 % (0,2 % dødelige)a
English: ≥75 years (N=2060)**
Danish: ≥ 75 år (N = 2.060)**
English: e Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Danish: e Klinisk åbenlys blødning, der er forbundet med et fald i hæmoglobin ≥ 3 g/dl men < 5 g/dl.