ELIQUIS

Država: Indonezija

Jezik: indonezijski

Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktivni sastojci:

APIXABAN

Dostupno od:

PFIZER INDONESIA - Indonesia

INN (International ime):

APIXABAN

Doziranje:

2.50 MG

Farmaceutski oblik:

TABLET SALUT SELAPUT

Jedinice u paketu:

DUS, 2 BLISTER @ 10 TABLET SALUT SELAPUT

Proizveden od:

PFIZER IRELAND PHARMACEUTICALS - Ireland

Datum autorizacije:

2021-04-22

Svojstava lijeka

Generic Name: Apixaban
Trade Name: ELIQUIS
CDS Effective Date: April 19, 2019
Supersedes: July 21, 2017
Approved by BPOM:
2020-0060265, 2020-0060262; 2020-0060155
Page 1 of 43
PT PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Apixaban
Trade Name: ELIQUIS
CDS Effective Date: April 19, 2019
Supersedes: July 21, 2017
1. NAME OF THE MEDICINAL PRODUCT
ELIQUIS 2.5 mg film-coated tablets.
ELIQUIS 5.0 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg and 5.0 mg apixaban,
respectively.
3. PHARMACEUTICAL FORM
2.5 mg: Yellow, round, biconvex film-coated tablets debossed with
“893” on one side
and “2½” on the other side.
5.0 mg: Pink, oval shaped, biconvex film-coated tablets debossed with
“894” on one side
and “5” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of VTE: elective hip or knee replacement surgery
Prevention
of
venous
thromboembolic
events
(VTE)
in
adult
patients
who
have
undergone elective hip or knee replacement surgery.
Prevention of stroke: non-valvular atrial fibrillation
ELIQUIS is indicated to reduce the risk of stroke in patients with
non-valvular atrial
fibrillation
with
one
or
more
risk
factors,
including
patients
unsuitable
for
warfarin/Vitamin K antagonist therapy (VKA).
Treatment of VTE
ELIQUIS is indicated for:
-
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
-
Prevention of recurrent DVT and PE.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ELIQUIS can be taken with or without food.
DISETUJUI OLEH BPOM : 31/03/2021
EREG100241VR12000460 EREG100241VR12000461
EREG100241VR12000462
Generic Name: Apixaban
Trade Name: ELIQUIS
CDS Effective Date: April 19, 2019
Supersedes: July 21, 2017
Approved by BPOM:
2020-0060265, 2020-0060262; 2020-0060155
Page 2 of 43
If a dose is missed, the patient should take ELIQUIS immediately and
then continue with
twice daily intake as before.
Posology
Prevention of VTE: elective hip or knee replacement surgery:
The recommended dose of ELIQUIS