Clexane Forte Syringes Solution for Injection 150mg per ml

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

ENOXAPARIN SODIUM

Dostupno od:

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

ATC koda:

B01AB05

INN (International ime):

ENOXAPARIN SODIUM 120 mg

Farmaceutski oblik:

SOLUTION FOR INJECTION

Sastav:

ENOXAPARIN SODIUM 120 mg

Tip recepta:

POM

Područje terapije:

ANTITHROMBOTIC AGENTS

Status autorizacije:

Withdrawn

Datum autorizacije:

2011-10-05

Uputa o lijeku

03/11/2015 17:46 - VISTAlink folder 1483711 - Page 1/19
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Is this leaflet hard to see or read?
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side-effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor, pharmacist
or nurse.
IN THIS LEAFLET:
1. What Clexane Forte is and what it is used for
2. Before you use Clexane Forte
3. How to use Clexane Forte
4. Possible side-effects
5. How to store and dispose of Clexane Forte
6. Further information 1. WHAT CLEXANE FORTE IS AND WHAT IT IS USED FOR
The name of your medicine is Clexane Forte
120mg or 150mg Pre-filled Syringes (called
Clexane Forte in this leaflet). Clexane Forte
contains
a
medicine
called
enoxaparin
sodium. This belongs to a group of medicines
called Low Molecular Weight Heparins.
CLEXANE FORTE 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.
CLEXANE FORTE CAN BE USED TO:
• Treat blood clots that are in your blood
• Stop blood clots forming in your blood
in the following situations:
• Unstable angina (where not enough
blood gets to your heart)
• After an operation or long periods of
bed rest due to illness
• After you have had a heart attack
• Stop blood clots forming in the tubes of
your dialysis machine (used for people
with kidney problems) 2. BEFORE YOU USE CLEXANE FORTE
DO NOT HAVE THIS MEDICINE AND TELL YOUR DOCTOR IF:
You are allergic (hypersensitive) to
enoxaparin sodium. Signs of an allergic
reaction
include:
a
rash,
swallowing or breathing problems,
swelling of your

Svojstava lijeka

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clexane® Forte Syringes
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
120 mg Injection Enoxaparin sodium 120 mg (equivalent to 12,000 IU
anti-Xa activity) in 0.8 mL
Water for Injections
150 mg Injection Enoxaparin sodium 150 mg (equivalent to 15,000 IU
anti-Xa activity) in 1.0 mL
Water for Injections
3
PHARMACEUTICAL FORM
Solution for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The prophylaxis of thromboembolic disorders of venous origin, in
particular those which may be
associated with orthopaedic or general surgery.
The prophylaxis of venous thromboembolism in medical patients
bedridden due to acute illness.
The treatment of venous thromboembolic disease presenting with deep
vein thrombosis,
pulmonary embolism or both.
The treatment of unstable angina and non-Q-wave myocardial infarction,
administered
concurrently with aspirin.
Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI)
including
patients to be managed medically or with subsequent Percutaneous
Coronary Intervention (PCI)
in conjunction with thrombolytic drugs (fibrin or non-fibrin
specific).
The prevention of thrombus formation in the extracorporeal circulation
during haemodialysis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the
recommended dosage is
20 mg (2,000 IU) once daily by subcutaneous injection for 7 to 10
days, or until the risk of
thromboembolism has diminished. In patients undergoing surgery, the
initial dose should be
given approximately 2 hours pre-operatively.
In patients with a higher risk, such as in orthopaedic surgery, the
dosage should be 40 mg (4,000
IU) daily by subcutaneous injection with the initial dose administered
approximately 12 hours
before surgery.
In patients with a high-risk of venous thromboembolism who undergo
abdominal or pelvic
surgery for cancer and are not otherwise at ri