Examples of using Prasugrel in English and their translations into German
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The active substance is prasugrel.
Prasugrel is a weak inhibitor of CYP2B6.
Each tablet contains 5 mg prasugrel as hydrochloride.
The use of prasugrel during breastfeeding is not recommended.
Each tablet contains 10 mg of prasugrel as hydrochloride.
Therefore, prasugrel should be used with caution in these patients.
Therefore, vorapaxar should not be used with prasugrel or ticagrelor.
Switching from prasugrel to Possia has not been investigated.
Embryo-foetal developmental toxicology studies in rats andrabbits showed no evidence of malformations due to prasugrel.
Therapeutic experience with prasugrel is limited in Asian patients.
In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit(p<0.001) for prasugrel versus clopidogrel.
Medicinal products metabolised by CYP2C9: prasugrel did not inhibit CYP2C9, as it did not affect the pharmacokinetics of S-warfarin.
Prasugrel should be used with caution in patients with a body weight of< 60 kg due to the potential risk of bleeding in this population see section 4.4.
The higher risk for bleeding events in subjects treated with prasugrel persisted up to 7 days from the most recent dose of study drug.
Prasugrel should be used with caution in patients≥ 75 years of age due to the potential risk of bleeding in this population see sections 4.2 and 4.4.
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.
Zontivity must not be used together with prasugrel or ticagrelor, two other medicines that help to prevent platelets from sticking together.
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.
Therapeutic experience with prasugrel is limited in patients with renal impairment(including ESRD) and in patients with moderate hepatic impairment.
Rifampicin(600 mg daily), a potent inducer of CYP3A and CYP2B6, and an inducer of CYP2C9, CYP2C19, and CYP2C8,did not significantly change the pharmacokinetics of prasugrel.
The benefits and risks of prasugrel should be carefully considered in patients in whom the coronary anatomy has not been defined and urgent CABG is a possibility.
Patients≥ 75 years of age have greater sensitivity to bleeding andhigher exposure to the active metabolite of prasugrel see sections 4.4, 4.8, 5.1 and 5.2.
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.
Although a pharmacodynamic interaction with ASA leading to an increased risk of bleeding is possible,the demonstration of the efficacy and safety of prasugrel comes from patients concomitantly treated with ASA.
Patients can be transitioned from cangrelor to prasugrel when prasugrel is administered immediately following discontinuation of the cangrelor infusion or up to one hour before, optimally at 30 minutes before the end of the cangrelor infusion to limit recovery of platelet reactivity.
Analysis of the composite endpoint in the All ACS population(combined UA/ NSTEMI and STEMI cohorts)was contingent on showing statistical superiority of prasugrel versus clopidogrel in the UA/ NSTEMI cohort p< 0.05.
A pharmacodynamic interaction study has been conducted with cangrelor and prasugrel, which demonstrated that cangrelor and prasugrel can be administered concomitantly.
The incidence of Non-CABG-related TIMI major bleeding, including life-threatening and fatal, as well as TIMI minor bleeding,was statistically significantly higher in subjects treated with prasugrel compared to clopidogrel in the UA/ NSTEMI and All ACS populations.
Following administration of a 900 mg loading dose of clopidogrel(with ASA), 56 subjects with ACS were treated for 14 days with either prasugrel 10 mg once daily or clopidogrel 150 mg once daily, and then switched to either clopidogrel 150 mg or prasugrel 10 mg for another 14 days.
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.
