e
Vials: 2 years
Diluted solution:
Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for:
- 8 hours (including infusion time) after dilution when stored at 20 °C ± 5 °C
- 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C ± 5 °C (including infusion time).
From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze the diluted solution.
For storage conditions after dilution of the medicinal product see section 6.3.
6.5 Nature and contents of container
10 ml of concentrate for solution for infusion in clear glass vials (type I) with a butyl rubber stopper covered by a purple flip-off aluminium seal cap.
Multipack containing 8 (2 packs of 4) vials.
6.6 Special precautions for disposal and other handling
Preparation of Busilvex
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:
- The use of gloves and protective clothing is recommended.
- If Busilvex or diluted Busilvex solution contacts the skin or mucosa, wash them thoroughly with water immediately.
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. By example:
The amount of Busilvex and diluent to be administered would be calculated as follows:
for a patient with a Y kg body weight:
• Quantity of Busilvex:
Y: body weight of the patient in kg
D: dose of Busilvex (see section 4.2)
• Quantity of diluent:
(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. Using a non polycarbonate syringe fitted with a needle:
- the calculated volume of Busilvex must be removed from the vial.
- the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent. Busilvex must always be added to the diluent, not the diluent to Busilvex. Busilvex must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
• The diluted solution must be mixed thoroughly by inverting several times.
After dilution, 1 ml of solution for infusion contains 0.5 |
