NOXFIBRA Solution for injection Ref.[50582] Active ingredients: Enoxaparin

Source: Web Search  Revision Year: 2020  Publisher: Sandoz SA (Pty) Ltd<sup>1</sup>, 72 Steel Road, Spartan, Kempton Park, 1619 1 Company Reg. No.: 1990/001979/07

Product name and form

NOXFIBRA 20 (Solution for injection).

NOXFIBRA 40 (Solution for injection).

NOXFIBRA 60 (Solution for injection).

NOXFIBRA 80 (Solution for injection).

NOXFIBRA 100 (Solution for injection).

Pharmaceutical Form

Noxfibra is a clear, colourless solution (clear liquid) that is free from visible particulate matter.

Qualitative and quantitative composition

Active ingredient:

Noxfibra 20 pre-filled syringe contains enoxaparin sodium 20 mg/0,2 ml (equivalent to 2 000 IU Anti Factor Xa).

Noxfibra 40 pre-filled syringe contains enoxaparin sodium 40 mg/0,4 ml (equivalent to 4 000 IU Anti Factor Xa).

Noxfibra 60 pre-filled syringe contains enoxaparin sodium 60 mg/0,6 ml (equivalent to 6 000 IU Anti Factor Xa).

Noxfibra 80 pre-filled syringe contains enoxaparin sodium 80 mg/0,8 ml (equivalent to 8 000 IU Anti Factor Xa).

Noxfibra 100 pre-filled syringe contains enoxaparin sodium 100 mg/ml (equivalent to 10 000 IU Anti Factor Xa).

Excipients: Water for injection.

Active Ingredient Description
Enoxaparin

Enoxaparin is a LMWH with a mean molecular weight of approximately 4,500 daltons, in which the antithrombotic and anticoagulant activities of standard heparin have been dissociated. The drug substance is the sodium salt and has a high anti-Xa activity.

List of Excipients

Pack sizes and marketing

Noxfibra 20: is a 0,2 ml (20 mg/0,2 ml) solution for injection, packed in 0,5 ml clear and colourless type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and an automatic safety device. The plunger rod is white in colour.

Noxfibra 40: is a 0,4 ml (40 mg/0,4 ml) solution for injection, packed in a 0,5 ml clear and colourless type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and an automatic safety device. The plunger rod is yellow in colour.

Noxfibra 60: is a 0,6 ml (60 mg/0,6 ml) solution for injection, packed in a 1 ml clear and colourless type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and an automatic safety device. The plunger rod is orange in colour.

Noxfibra 80: is a 0,8 ml (80 mg/0,8 ml) solution for injection, packed in a 1 ml clear and colourless type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and an automatic safety device. The plunger rod is brown in colour.

Noxfibra 100: is a 1 ml (100 mg/ml) solution for injection, packed in a 1 ml clear and colourless type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and an automatic safety device. The plunger rod is black in colour.

The pre-filled syringes are packed into an outer cardboard carton.

NOXFIBRA pre-filled syringes are packed in 10’s.

Marketing authorization holder

Sandoz SA (Pty) Ltd1, 72 Steel Road, Spartan, Kempton Park, 1619

1 Company Reg. No.: 1990/001979/07

Marketing authorization dates and numbers

Noxfibra 20: 52/8.2/0495
Noxfibra 40: 52/8.2/0496
Noxfibra 60: 52/8.2/0497
Noxfibra 80: 52/8.2/0498
Noxfibra 100: 52/8.2/0499

Date of registration: 25 February 2020

Drugs

Drug Countries
NOXFIBRA South Africa

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