Injection Solution

Pre-filled syringes

Argentine Industry Dispense under prescription

ENOXDOWN 20:

Each pre-filled syringe contains:

Enoxaparin sodium................................ 20.00 mg

Water for injection q.s................................ 0.20 ml

1 M NaOH or 1 M HCl................................ q.s.

ENOXDOWN 40:

Each pre-filled syringe contains:

Enoxaparin sodium................................ 40.00 mg

Water for injection q.s................................ 0.40 ml

1 M NaOH or 1 M HCl................................ q.s.

ENOXDOWN 60:

Each pre-filled syringe contains:

Enoxaparin sodium................................ 60.00 mg

Water for injection q.s................................ 0.60 ml

1 M NaOH or 1 M HCl................................ q.s.

ENOXDOWN 80:

Each pre-filled syringe contains:

Enoxaparin sodium................................ 80.00 mg

Water for injection q.s................................ 0.80 ml

1 M NaOH or 1 M HCl................................ q.s.

ENOWDOWN 100:

Each pre-filled syringe contains:

Enoxaparin sodium................................ 100.00 mg

Water for injection q.s................................ 1.00 ml

1 M NaOH or 1 M HCl ................................ q.s.

Antithrombotic agent.

ENOXDOWN is indicated for the prophylaxis of deep vein thrombosis that may cause pulmonary embolism:

In patients undergoing abdominal surgery with risk of thromboembolic complications;

In patients undergoing hip replacement surgery, previously and after the hospitalisation;

In patients undergoing knee replacement surgery;

In medical patients with risk of thromboembolic complications due to severely restricted mobility during acute illness.

ENOXDOWN is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, with concurrent administration of aspirin.

ENOXDOWN is indicated for:

The inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, administered in conjunction with warfarin sodium;

o The outpatient treatment of acute deep vein thrombosis with or without pulmonary embolism administered in conjunction with warfarin sodium.

ENOXDOWN is administered by subcutaneous injection. It must not be administered by intramuscular injection. ENOXDOWN is intended for use under the guidance of a physician. Patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, if necessary. Prior training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.

ENOXDOWN must be used with extreme caution in patients with history of heparin-induced thrombocytopenia.

ENOXDOWN 20: 1, 2 and 10 pre-filled syringes containing 0.2 ml.

ENOXDOWN 40: 1, 2 and 10 pre-filled syringes containing 0.4 ml.

ENOXDOWN 60: 1, 2 and 10 pre-filled syringes containing 0.6 ml.

ENOXDOWN 80: 1, 2 and 10 pre-filled syringes containing 0.8 ml.

ENOXDOWN 100: 1, 2 and 10 pre-filled syringes containing 1.0 ml.

KEEP AT TEMPERATURE BELOW 25 ºC AND PROTECTED FROM THE LIGHT. DO NOT REFRIGERATE OR FREEZE.

ENOXDOWN pre-filled syringes contain a single dose. Dispose of any unused product. Do not use after the expiration date.

KEEP OUT OF THE REACH OF CHILDREN.

Medicinal specialty authorised by the Ministry of Health.

Certificate No. 55578