RIVAXORED (Rivaroxaban Tablets 10mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RIVAROXABAN

Boleh didapati daripada:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

RIVAROXABAN

Unit dalam pakej:

10 Tablets; 30 Tablets

Dikeluarkan oleh:

DR. REDDY'S LABORATORIES LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Page 1
RIVAXORED (RIVAROXABAN TABLETS 10MG)
_RIVAROXABAN _(10MG)
WHAT IS IN THIS LEAFLET
1.
What Rivaxored is used for
2.
How Rivaxored works
3.
Before you use Rivaxored
4.
How to use Rivaxored
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Rivaxored
8.
Product Description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT RIVAXORED IS USED FOR
Rivaxored 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 RIVAXORED WORKS
Rivaxored 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 RIVAXORED
-
_When you must not use it _
Do not take Rivaxored
- 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 Rivaxored 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 Rivaxored.
_Take special care with Rivaxored _
- if you have an increased risk of
bleeding, as could be the case in
situations such as:
▪ moderate or severe kidney disease,
since y

Ciri produk

PACK INSERT
Page 1 of 14
RIVAXORED (RIVAROXABAN TABLETS 10MG)
1.
NAME OF THE MEDICINAL PRODUCT
RIVAXORED (Rivaroxaban Tablets 10mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rivaroxaban.
Excipients: Each 10 mg film-coated tablet contains lactose
monohydrate, see section 4.4.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Light Pink colored, round biconvex film coated tablets, engraved with
‘10’ on one side and plain on
other side.
4.
CLINICAL INFORMATION
4.1 THERAPEUTIC INDICATIONS
Prevention of venous thromboembolism (VTE) in adult patients
undergoing elective hip or knee
replacement surgery
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 10 mg 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 Rivaxored immediately and
then continue the following day
with once daily intake as before.
Converting from Vitamin K Antagonists (VKA) to Rivaxored
When converting patients from VKAs to Rivaxored, International
Normalized Ratio (INR) values will
be falsely elevated after the intake of Rivaxored. The INR is not
valid to measure the anticoagulant
activity of Rivaxored, and therefore should not be used (see section
4.5).
Converting from Rivaxored to Vitamin K antagonists (VKA)
There is a potential for inadequate anticoagulation during the
transition from Rivaxored to VKA.
Continuous
adequate
anticoagulation
should
be
ensured
during
any
transition
to
an
alternate
anticoagulant. It should be noted that Rivaxored can contribute to an
elevated INR.
In patient