GENEXIBAN (Apixaban Film-Coated Tablets 2.5mg)

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

APIXABAN

Inapatikana kutoka:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (Jina la Kimataifa):

APIXABAN

Vitengo katika mfuko:

60 Tablets

Viwandani na:

DR. REDDY'S LABORATORIES LIMITED

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
GENEXIBAN (APIXABAN FILM-COATED TABLETS 2.5MG)
GENEXIBAN (APIXABAN FILM-COATED TABLETS 5MG)
Apixaban (2.5 mg, 5 mg)
WHAT IS IN THIS LEAFLET
1.
What GENEXIBAN is used for
2.
How GENEXIBAN works
3.
Before you use GENEXIBAN
4.
How to use GENEXIBAN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
GENEXIBAN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT GENEXIBAN IS USED FOR
GENEXIBAN is used to
-
prevent blood clots in veins (venous
thromboembolic events (VTE)) after
a hip or knee replacement surgery.
-
prevent stroke and blood clots in
adult patients with a condition called
non-valvular atrial fibrillation, which
is a type of irregular heart rhythm
with one or more risk factors, such
as:
•
previous stroke condition or
transient ischaemic attack (TIA)
(mini stroke);
•
age ≥75 years
•
high blood pressure
(hypertension)
•
high blood sugar levels
(diabetes mellitus)
•
symptomatic heart failure
(NYHA Class ≥II).
-
treat blood clots occurring in deep
veins (Deep Vein Thrombosis
[DVT]) and clots in your lungs
(Pulmonary Embolism [PE]) and
also to prevent these from recurring.
HOW GENEXIBAN WORKS
The active substance in Genexiban is
apixaban. It helps to prevent blood clot
formation by inhibiting Factor Xa, which
is an important component of blood
clotting.
BEFORE YOU USE GENEXIBAN
-
_When you must not use it _
_ _
Do not take GENEXIBAN if
-
you are allergic to Apixaban or to
any of the other ingredients listed at
the end of this leaflet
-
you have an injury to a body organ
or any internal bleeding
-
you have liver disease associated
with a bleeding disorder called
coagulopathy and an increased risk
of bleeding
-
you have any condition or injury to a
body organ that could lead to
significant bleeding (such as ulcers
in stomach; cancerous growth;
recent brain or spinal injury; recent
brain, spinal or eye surgery;
bleeding in the brain; abnormal,
enlarged veins in the tube

Tabia za bidhaa

GENEXIBAN (APIXABAN FILM-COATED TABLETS 2.5MG)
GENEXIBAN (APIXABAN FILM-COATED TABLETS 5MG)
1
PACKAGE LEAFLET
1.
NAME OF THE MEDICINAL PRODUCT
GENEXIBAN (Apixaban Film-Coated Tablets 2.5mg)
GENEXIBAN (Apixaban Film-Coated Tablets 5mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_GENEXIBAN (Apixaban Film-Coated Tablets 2.5mg) _
Each film-coated tablet contains 2.5 mg Apixaban
_GENEXIBAN (Apixaban Film-Coated Tablets 5mg) _
Each film-coated tablet contains 5.0 mg Apixaban
3.
PHARMACEUTICAL FORM
Film coated tablet
_GENEXIBAN (Apixaban Film-Coated Tablets 2.5mg) _
White to off white colored, round shaped, biconvex, film coated
tablet, debossed with ‘2.5’ on
one side and and ‘
’ (logo) on the other side.
_GENEXIBAN (Apixaban Film-Coated Tablets 5mg) _
White to off white colored, oval shaped, biconvex, film coated tablet,
debossed with ‘5’ on one
side and ‘
’ (logo) on the other side.
4. CLINICAL PARTICULARS
4.1 INDICATIONS
_For 2.5 mg _
Prevention of venous thromboembolic events (VTE) in adult patients who
have undergone
elective hip or knee replacement surgery.
_For 2.5 mg and 5 mg _
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 Special Warnings and
Precautions for Use) 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 Genexiban 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 t