How should it be stored?

What Busilvex contains

What Busilvex looks like and contents of the pack
Busilvex consists of a concentrate for solution for infusion and is supplied in colourless glass vials, each vial containing 60 mg of busulfan.
When diluted Busilvex is a clear colourless solution.

Busilvex is available in a box containing 8 vials.

Marketing Authorisation Holder
Pierre Fabre Médicament
45, place Abel Gance
F-92654 Boulogne-Billancourt cedex
France

Manufacturer
Pierre Fabre Médicament Production, site Aquitaine Pharm International
Avenue du béarn
F-64320 Idron
France

This leaflet was last approved on:

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The following information is intended for medical or healthcare professionals only

PREPARATION GUIDE

Busilvex 6 mg/ml concentrate for solution for infusion
Busulfan

Read this guide prior to the preparation and administration of Busilvex.

PRESENTATION

Busilvex is supplied as a clear colourless solution in 10 ml clear glass vials (type I). Busilvex must be diluted prior to administration.

RECOMMENDATION FOR SAFE HANDLING

Procedures for proper handling and disposal of anticancer medicinal products should be considered.

All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood

As with other cytotoxic compounds, caution should be exercised in handling and preparing the Busilvex solution:

Calculation of the quantity of Busilvex to be diluted and of the diluent
Busilvex must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5% .
The quantity of the diluent must be 10 times the volume of Busilvex ensuring the final concentration of busulfan remains at approximately 0.5 mg/ml.

The amount of Busilvex and diluent to be administered would be calculated as follows: for a patient with a Y kg body weight:

Y (kg) x D (mg/kg)

= A ml of Busilvex to be diluted

6 (mg/ml)

Y: body weight of the patient in kg
D: dose of Busilvex (see SPC section 4.2)

(A ml Busilvex) x (10) = B ml of diluent

To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%)

Preparation of the solution for infusion
Busilvex must be prepared by a healthcare professional using sterile transfer techniques.

After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan

Diluted Busilvex is a clear colourless solution

Instructions for use
Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution f