Enoxaparin Sandoz 2000 IU (20 mg) 0.2 mL Solution for Injection in Pre-filled Syringe

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ENOXAPARIN SODIUM

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ENOXAPARIN SODIUM

Unit dalam pakej:

2 Units; 6 Units; 10 Units; 12 Units

Dikeluarkan oleh:

Rovi Pharma Industrial Services S.A

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
ENOXAPARIN
_®_ SANDOZ
_ _
Enoxaparin Sodium 20mg (2,000/0.2ml) – 40mg (4,000/0.4ml) – 60mg
(6,000/0.6ml)
1
WHAT IS IN THIS LEAFLET
1.
What Enoxaparin Sandoz is used
for
2.
How Enoxaparin Sandoz works
3. Before you use Enoxaparin Sandoz
4.
How to use Enoxaparin Sandoz
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Enoxaparin Sandoz
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT ENOXAPARIN SANDOZ IS USED
FOR
The name of your medicine is
Enoxaparin Sandoz 20 mg (2,000 IU)
solution for injection in pre-filled
syringe. Enoxaparin Sandoz contains
a medicine called enoxaparin sodium.
This belongs to a group of medicines
called low molecular weight heparins.
Enoxaparin Sandoz can be used to:
• Treat blood clots that are in your
blood (deep vein thrombosis with or
without pulmonary embolism).
• Stop blood clots forming in your
blood in the following situations:
- After an operation or long periods
of bed rest due to illness.
- Unstable angina (where not enough
blood gets to your heart).
- After you have had a heart attack.
• Stop blood clots forming in the
tubes of your dialysis machine (used
for people with kidney problems).
HOW ENOXAPARIN SANDOZ WORKS
Enoxaparin Sandoz works in two
ways:
1) Stopping existing blood clots from
getting any bigger. This helps your
body to break them down and stop
them causing you harm.
2) Stopping blood clots forming in
your blood.
BEFORE YOU USE ENOXAPARIN SANDOZ
_- When you must not use it _
_ _
Do not use Enoxaparin Sandoz:
-if you are allergic to enoxaparin
sodium. Signs of an allergic reaction
_ _
include: a rash, swallowing or
breathing problems, swelling of your
_ _
lips, face, throat or tongue,
_ _
- if you are allergic to heparin or
other low molecular weight heparins,
- if you have an acute infection in
your heart,
- if you are having severe bleedings
or if you suffer from conditions in
which the risk for severe bleeding is
increased:
- if you ha

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
Enoxaparin Sandoz 2,000 IU (20 mg) /0.2 mL Solution for Injection in
Pre-filled Syringe
Enoxaparin Sandoz 4,000 IU (40 mg) /0.4 mL Solution for Injection in
Pre-filled Syringe
Enoxaparin Sandoz 6,000 IU (60 mg) /0.6 mL Solution for Injection in
Pre-filled Syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2,000 IU (20 mg) /0.2 mL
Each prefilled syringe contains enoxaparin sodium 2,000 IU anti-Xa
activity (equivalent to 20 mg) in 0.2 mL
water for injections.
4,000 IU (40 mg) /0.4 mL
Each prefilled syringe contains enoxaparin sodium 4,000 IU anti-Xa
activity (equivalent to 40 mg) in 0.4 mL
water for injections.
6,000 IU (60 mg) /0.6 mL
Each prefilled syringe contains enoxaparin sodium 6,000 IU anti-Xa
activity (equivalent to 60 mg) in 0.6 mL
water for injections.
For the full list of excipients, see section 6.1.
Enoxaparin sodium is a biological substance obtained by alkaline
depolymerization of heparin benzyl ester
derived from porcine intestinal mucosa.
Enoxaparin Sandoz has been developed as a similar biological medicinal
product to Clexane and has been
shown to have a comparable quality, safety and efficacy profile to
Clexane. Therefore, interchangeability
with the reference product is possible, as long as this is in
agreement with the treating physician. However,
automatic substitution (i.e the practice by which a different product
to that specified on the prescription is
dispensed to the patient without the prior informed consent of the
treating physician) and active substance-
based prescription cannot apply to biologicals, including biosimilars.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe (injection).
Clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Enoxaparin Sandoz is indicated in adults for:
•
Prophylaxis of venous thromboembolic disease in moderate and high risk
surgical patients, in particular
those undergoing orthopaedic or general surgery including cancer
surgery.
•
Prevention of thrombus forma