Hemapix Film Coated Tablet 5mg

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

APIXABAN

Tillgänglig från:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International namn):

APIXABAN

Enheter i paketet:

60 Tablets; 20 Tablets

Tillverkad av:

Sandoz Private Limited

Bipacksedel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
HEMAPIX FILM COATED TABLET
_ _
Apixaban (2.5mg and 5mg)
1
WHAT IS IN THIS LEAFLET
1. What Hemapix is used for
2. How Hemapix works
3. Before you use Hemapix
4. How to use Hemapix
5. While you are using it
6. Side effects
7. Storage & Disposal of Hemapix
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT HEMAPIX IS USED FOR
Hemapix 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
HEMAPIX WORKS
The active substance in Hemapix is
apixaban. It helps to prevent blood
clot formation by inhibiting Factor
Xa, which is an important component
of blood clotting.
BEFORE YOU USE HEMAPIX
_- When you must not use it _
Do not take Hemapix 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 increase 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 that connects the throat and
stomach (esophagus); an
abnormal connection between
arter

Produktens egenskaper

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PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Hemapix Film Coated Tablet 2.5mg
Hemapix Film Coated Tablet 5mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Hemapix Film Coated Tablet 2.5mg
Each film coated tablet contains 2.5mg of apixaban.
Hemapix Film Coated Tablet 5mg
Each film coated tablet contains 5mg of apixaban.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablet.
Hemapix Film Coated Tablet 2.5mg
Yellow, round, biconvex, film coated tablet, debossed AX on one side
and 2.5 on the opposite side
Hemapix Film Coated Tablet 5mg
Pink, oval, biconvex, film coated tablet, debossed AX on one side and
5 on the opposite side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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 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 Hemapix 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.
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PREVENTION OF ST