Eliquis 2,5mg tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

apixaban

Available from:

Bristol-Myers Squibb S.R.L.

ATC code:

B01AF02

INN (International Name):

apixaban

Dosage:

2,5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(20/2x10/) blisters, (60/6x10/) blisters

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-07-03

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Eliquis 2.5 mg film-coated tablets
2.
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 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Yellow, round tablets debossed with 893 on one side and 2½ on the
other side.
4.
CLINICAL PARTICULARS
4.1
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 atrial fibrillation
(NVAF), with one or more risk factors, such as prior stroke or
transient ischaemic attack (TIA); age
≥ 75 years; hypertension; diabetes mellitus; symptomatic heart
failure (NYHA Class ≥ II).
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent
DVT and PE in adults (see section 4.4 for haemodynamically unstable PE
patients).
4.2
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.
Physicians may consider the potential benefits of earlier
anticoagulation for VTE prophylaxis as well
as the risks of post-surgical bleeding in deciding on the time of
administration within this time
window.
_In patients undergoing hip replacement surgery _
The recommended duration of treatment is 32 to 38 days.
_In patients undergoing knee replacement surgery _
The recommended duration of treatment is 10 to 14 days.
_Prevention of stroke and systemic embolism in patients with
non-valvular atrial fibrillation (NVAF) _
The recommended dose of apixaban is 5 mg taken orally twice daily.
3
_Dose reduction _
The recommended dose of apixaban is 2