Clexane 300mg/3ml solution for injection multidose vials

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Enoxaparin sodium

Boleh didapati daripada:

Sanofi

Kod ATC:

B01AB05

INN (Nama Antarabangsa):

Enoxaparin sodium

Dos:

100mg/1ml

Borang farmaseutikal:

Solution for injection

Laluan pentadbiran:

Intraarterial; Intravenous; Subcutaneous

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 02080100; GTIN: 5000283652748

Risalah maklumat

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLEXANE
® MULTIDOSE VIAL 30,000 IU (300 MG)/3 ML SOLUTION FOR INJECTION
enoxaparin sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Clexane Multidose Vial is and what it is used for
2.
What you need to know before you use Clexane Multidose Vial
3.
How to use Clexane Multidose Vial
4.
Possible side effects
5.
How to store Clexane Multidose Vial
6.
Contents of the pack and other information
1.
WHAT CLEXANE MULTIDOSE VIAL IS AND WHAT IT IS USED FOR
Clexane Multidose Vial contains the active substance called enoxaparin
sodium that is a low
molecular weight heparin (LMWH).
Clexane Multidose Vial works in two ways.
1)
Stopping existing blood clots from getting any bigger. This helps your
body to break them
down and stops them from causing you harm
2)
Stopping blood clots from forming in your blood.
Clexane Multidose Vial can be used to:
•
Treat blood clots that are in your blood
•
Stop blood clots from forming in your blood in the following
situations:
o
Before and after an operation
o
When you have an acute illness and face period of limited mobility
o
When you have unstable angina (a condition when not enough blood gets
to your
heart)
o
After a heart attack
•
Stop blood clots forming in the tubes of your dialysis machine (used
for people with severe
kidney problems).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CLEXANE MULTIDOSE VIAL
DO NOT USE CLEXANE MULTIDOSE VIAL
•
If you are allergic to enoxaparin sodium or any of the other
ingredien

Ciri produk

OBJECT 1
CLEXANE MULTIDOSE VIAL
Summary of Product Characteristics Updated 09-Jun-2017 | SANOFI
1. Name of the medicinal product
Clexane
®
Multidose Vial 30,000 IU (300 mg)/3 ml solution for injection
2. Qualitative and quantitative composition
_30,000 IU (300 mg) /3 ml_
One vial contains enoxaparin sodium 30,000 IU anti-Xa activity
(equivalent to 300 mg) + 45 mg benzyl
alcohol in 3.0 ml water for injections.
Excipient(s) with known effect: benzyl alcohol.
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.
3. Pharmaceutical form
Sterile pyrogen-free solution for injection contained in a multidose
vial for single patient use.
Clear, colourless to slightly yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Clexane Multidose Vial 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.
• Prophylaxis of venous thromboembolic disease in medical patients
with an acute illness (such as acute
heart failure, respiratory insufficiency, severe infections or
rheumatic diseases) and reduced mobility at
increased risk of venous thromboembolism.
• Treatment of deep vein thrombosis (DVT) and pulmonary embolism
(PE), excluding PE likely to
require thrombolytic therapy or surgery.
• Prevention of thrombus formation in extra corporeal circulation
during haemodialysis.
• Acute coronary syndrome:
- Treatment of unstable angina and Non ST-segment elevation myocardial
infarction (NSTEMI), in
combination with oral acetylsalicylic acid.
- Treatment of acute ST-segment elevation myocardial infarction
(STEMI) including patients to be
managed medically or with subsequent percutaneous coronary
intervention (PCI).
4.2 Posology and method of administration
Posology
_Prophylaxis of venous thromboembolic disease in moderate an