EFIENT Film-coated tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Efient 10 mg film-coated tablets. Efient 5 mg film-coated tablets.
Qualitative and quantitative composition
Efient 10 mg: Each tablet contains 10 mg prasugrel (as hydrochloride). Excipient(s) with known effect: Each tablet contains 2.1 mg lactose. Efient 5 mg: Each tablet contains 5 mg prasugrel (as hydrochloride). ...
Pharmaceutical form
Film-coated tablet (tablet). <u>Efient 10 mg:</u> Beige and double-arrow shaped tablets, debossed with 10 MG on one side and 4759 on the other. <u>Efient 5 mg:</u> Yellow and double-arrow shaped tablets, ...
Therapeutic indications
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment ...
Posology and method of administration
Posology Adults Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day. In UA/NSTEMI patients, where coronary angiography is performed within 48 hours after ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active pathological bleeding. History of stroke or transient ischaemic attack (TIA). Severe hepatic impairment ...
Special warnings and precautions for use
Bleeding risk In the phase 3 clinical trial (TRITON) key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings. Patients ...
Interaction with other medicinal products and other forms of interaction
Warfarin Concomitant administration of Efient with coumarin derivatives other than warfarin has not been studied. Because of the potential for increased risk of bleeding, warfarin (or other coumarin derivatives) ...
Fertility, pregnancy and lactation
No clinical study has been conducted in pregnant or breast-feeding women. Pregnancy Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition ...
Effects on ability to drive and use machines
Prasugrel is expected to have no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile 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 ...
Overdose
Overdose of Efient may lead to prolonged bleeding time and subsequent bleeding complications. No data are available on the reversal of the pharmacological effect of prasugrel; however, if prompt correction ...
Pharmacodynamic properties
Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin ATC code: B01AC22 Mechanism of action/Pharmacodynamic effects Prasugrel is an inhibitor of platelet activation and aggregation ...
Pharmacokinetic properties
Prasugrel is a prodrug and is rapidly metabolised in vivo to an active metabolite and inactive metabolites. The active metabolites exposure (AUC) has moderate to low between-subject (27%) and within-subject ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction. Effects ...
List of excipients
<u>Tablet Core:</u> Microcrystalline cellulose Mannitol (E421) Croscarmellose sodium Hypromellose (E464) Magnesium stearate <u>Film-Coat:</u> Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) ...
Incompatibilities
Not applicable.
Shelf life
Efient 10 mg: 3 years. Efient 5 mg: 2 years.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from air and moisture.
Nature and contents of container
Aluminium foil blisters in cartons of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379, Munich, Germany
Marketing authorization number(s)
Efient 5 mg: EU/1/08/503/001 – 007, 015 Efient 10 mg: EU/1/08/503/008 – 014, 016
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 February 2009 Date of latest renewal: 13 November 2013
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
