Rivax 10mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RIVAROXABAN

Boleh didapati daripada:

NOVUGEN PHARMA SDN. BHD.

INN (Nama Antarabangsa):

RIVAROXABAN

Unit dalam pakej:

1 x 10 Tablets; 3 x 10 Tablets; 6 x 10 Tablets; 10 x 10 Tablets; 50 x 10 Tablets; 100 x 10 Tablets; 2 x 14 Tablets; 1 x 14 Table

Dikeluarkan oleh:

NOVUGEN PHARMA SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RIVAX 10MG FILM COATED TABLETS
Rivaroxaban 10mg
1
WHAT IS IN THIS LEAFLET
1.
What Rivax is used for
2.
How Rivax works
3.
Before you use Rivax
4.
How to use Rivax
5.
While you are using Rivax
6.
Side effects
7.
Storage and Disposal of Rivax
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT RIVAX IS USED FOR
Rivax
contains
the
active
substance
Rivaroxaban and is used in adults to
•
prevent blood clots in the veins after
a hip or knee replacement operation.
Your
doctor
has
prescribed
this
medicine for you because after an
operation you are at an increased
risk of getting blood clots.
HOW RIVAX WORKS
Rivax belongs to a group of medicines
called antithrombotic agents. It works
by
blocking
a
blood
clotting
factor
(factor
Xa)
and
thus
reducing
the
tendency of the blood to form clots.
BEFORE YOU USE RIVAX
−
_When you must not use it _
Do not take Rivax
-
if you are allergic to rivaroxaban or
any of the other ingredients of this
medicine
-
if you are bleeding excessively
-
if you have a disease or condition in
an organ of the body that increases
the risk of serious bleeding (e.g.
stomach ulcer, injury or bleeding in
the brain, recent surgery of the brain
or eyes)
-
if
you
are
taking
medicines
to
prevent
blood
clotting
(e.g.
warfarin,
dabigatran,
apixaban
or
heparin),
except
when
changing
anticoagulant
treatment
or
while
getting heparin through a venous or
arterial line to keep it open
-
if you have a liver disease which
leads
to
an
increased
risk
of
bleeding
-
if you are pregnant or breast-feeding
Do not take Rivax and tell your doctor
if any of these apply to you.
−
_Before you start to use it_
_Warnings and precautions _
Talk
to
your
doctor
or
pharmacist
before taking Rivax
_Take special care with Rivax _
-
if you have an increased risk of
bleeding, as could be the case in
situations such as:
•
moderate
or
severe
kidney
disease,
since
your
kidney
function
may
affect
the
amount of medicine that wor

Ciri produk

RIVAX 10MG
FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Rivax 10mg Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of Rivaroxaban.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Light red, round biconvex film-coated tablet, debossed with ‘E5’
on one side and plain on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of venous thromboembolism (VTE) in adult patients
undergoing elective hip or knee
replacement surgery.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent
DVT and PE in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of VTE in patients undergoing elective hip or knee
replacement surgery _
The recommended dose is 10mg rivaroxaban taken orally once daily. The
initial dose should be taken
6 to 10 hours after surgery, provided that haemostasis has been
established.
The duration of treatment depends on the individual risk of the
patient for venous thromboembolism
which is determined by the type of orthopaedic surgery.
•
For patients undergoing major hip surgery, a treatment duration of 5
weeks is recommended.
•
For patients undergoing major knee surgery, a treatment duration of 2
weeks is recommended.
If a dose is missed the patient should take Rivax immediately and then
continue the following day
with once daily intake as before.
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE _
The recommended dose for the initial treatment of acute DVT or PE is
15mg twice daily for the first
three weeks followed by 20mg once daily for the continued treatment
and prevention of recurrent
DVT and PE.
Short duration of therapy (at least 3 months) should be considered in
patients with DVT or PE
provoked by major transient risk factors (i.e. recent major surgery or
trauma). Longer duration of
therapy should be considered in patients with provoked DVT or PE not
related to major transient risk
factors, un