Eliquis Tablet 2.5mg

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Apixaban

זמין מ:

PFIZER PRIVATE LIMITED

קוד ATC:

B01AF02

כמות:

2.5mg

טופס פרצבטיות:

TABLET, FILM COATED

הרכב:

Apixaban 2.5mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

Prescription Only

תוצרת:

Bristol-Myers Squibb Manufacturing Company Unlimited Company

מצב אישור:

ACTIVE

תאריך אישור:

2012-12-24

עלון מידע

ELIQUIS 2.5 MG FILM-COATED TABLETS
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page 1 of 27
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.
Excipient(s) with known effect
Each 2.5 mg film-coated tablet contains 51.4 mg lactose (see section
4.4).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex film-coated tablets with “893” debossed 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.
Page 2 of 27
_Prevention of stroke and systemic embolism

מאפייני מוצר

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.
Excipient(s) with known effect
Each 2.5 mg film-coated tablet contains 51.4 mg lactose (see section
4.4).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex film-coated tablets with “893” debossed 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.
_Dose reduction_
The recommended dose of apixaban is 2.5 mg taken orally twice daily in
pa