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SPC: EFIENT Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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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). Efient 10 mg: Beige and double-arrow shaped tablets, debossed with 10 MG on one side and 4759 on the other. Efient 5 mg: Yellow and double-arrow shaped tablets, debossed with ...

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

Tablet Core: Microcrystalline cellulose Mannitol (E421) Croscarmellose sodium Hypromellose (E464) Magnesium stearate Film-Coat: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin ...

Incompatibilities

Not applicable.

Shelf life

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

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