Eliquis 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:

5mg

Pharmaceutical form:

tablets film-coated

Units in package:

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

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-07-16

Summary of Product characteristics

27
1.
NAME OF THE MEDICINAL PRODUCT
Eliquis 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg apixaban.
Excipients with known effect
Each 5 mg film-coated tablet contains 102.86 mg lactose (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pink, oval tablets debossed with 894 on one side and 5 on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 stroke and systemic embolism in patients with
non-valvular atrial fibrillation (NVAF) _
The recommended dose of apixaban is 5 mg taken orally twice daily.
_Dose reduction_
The recommended dose of apixaban is 2.5 mg taken orally twice daily in
patients with NVAF and at
least two of the following characteristics: age ≥ 80 years, body
weight ≤ 60 kg, or serum creatinine
≥ 1.5 mg/dL (133 micromole/L).
Therapy should be continued long-term.
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE (VTEt)_
The recommended dose of apixaban for the treatment of acute DVT and
treatment of PE is 10 mg
taken orally twice daily for the first 7 days followed by 5 mg taken
orally twice daily. As per available
medical guidelines, short duration of treatment (at least 3 months)
should be based on transient risk
factors (e.g., recent surgery, trauma, immobilisation).
The recommended dose of apixaban for the prevention of recurrent DVT
and PE is 2.5 mg taken orally
twice daily. When prevention of re