ELIQUIS Film-coated tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Eliquis 2.5 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 2.5 mg apixaban. Excipients with known effect: Each 2.5 mg film-coated tablet contains 51.43 mg lactose (see section 4.4). For the full list of excipients, see section ...
Pharmaceutical form
Film-coated tablet (tablet). Yellow, round tablets debossed with 893 on one side and 2 1⁄2 on the other side.
Therapeutic indications
Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular ...
Posology and method of administration
Posology Prevention of VTE (VTEp): elective hip or knee replacement surgery The recommended dose of apixaban is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery. ...
Contraindications
*Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active clinically significant bleeding. Hepatic disease associated with coagulopathy and clinically relevant ...
Special warnings and precautions for use
Haemorrhage risk As with other anticoagulants, patients taking Eliquis are to be carefully observed for signs of bleeding. It is recommended to be used with caution in conditions with increased risk of ...
Interaction with other medicinal products and other forms of interaction
Inhibitors of CYP3A4 and P-gp Coadministration of apixaban with ketoconazole (400 mg once a day), a strong inhibitor of both CYP3A4 and P-gp, led to a 2-fold increase in mean apixaban AUC and a 1.6-fold ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of apixaban in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Apixaban is not recommended ...
Effects on ability to drive and use machines
Eliquis has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The safety of apixaban has been investigated in 7 Phase III clinical studies including more than 21,000 patients: more than 5,000 patients in VTEp studies, more than 11,000 ...
Overdose
There is no antidote to Eliquis. Overdose of apixaban may result in a higher risk of bleeding. In the event of haemorrhagic complications, treatment must be discontinued and the source of bleeding investigated. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antithrombotic agents, direct factor Xa inhibitors ATC code: B01AF02 Mechanism of action Apixaban is a potent, oral, reversible, direct and highly selective active site inhibitor ...
Pharmacokinetic properties
Absorption The absolute bioavailability of apixaban is approximately 50% for doses up to 10 mg. Apixaban is rapidly absorbed with maximum concentrations (C<sub>max</sub>) appearing 3 to 4 hours after tablet ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, fertility and embryo-foetal development ...
List of excipients
<u>Tablet core:</u> Anhydrous lactose Microcrystalline cellulose (E460) Croscarmellose sodium Sodium laurilsulfate Magnesium stearate (E470b) <u>Film coat:</u> Lactose monohydrate Hypromellose (E464) ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage condition.
Nature and contents of container
Alu-PVC/PVdC blisters. Cartons of 10, 20, 60, 168 and 200 film-coated tablets. Alu PVC/PVdC perforated unit dose blisters of 60x1 and 100x1 film-coated tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Bristol-Myers Squibb/Pfizer EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH, United Kingdom
Marketing authorization number(s)
EU/1/11/691/001 EU/1/11/691/002 EU/1/11/691/003 EU/1/11/691/004 EU/1/11/691/005 EU/1/11/691/013 EU/1/11/691/015
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 May 2011 Date of latest renewal: 14 January 2016
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