Clexane Multidose Vial Solution for Injection 100mg per ml

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

ENOXAPARIN SODIUM

Disponível em:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

Código ATC:

B01AB05

DCI (Denominação Comum Internacional):

ENOXAPARIN SODIUM 100 mg/ml

Forma farmacêutica:

SOLUTION FOR INJECTION

Composição:

ENOXAPARIN SODIUM 100 mg/ml

Tipo de prescrição:

POM

Área terapêutica:

ANTITHROMBOTIC AGENTS

Status de autorização:

Withdrawn

Data de autorização:

2010-05-12

Folheto informativo - Bula

Page 1 of 8
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
in

Características técnicas

Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clexane Multidose Vialis 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 and high
risk surgical patients _
Individual thromboembolic risk for patients can be estimated usin