r, aluminium seal and plastic flip-off cap, containing 4 mg of mifamurtide.
Each carton contains one vial and one single-use, non-pyrogenic, latex-free sterile Filter for MEPACT supplied in a PVC-grade blister.
6.6 Special precautions for disposal and other handling
MEPACT must be reconstituted, filtered using the filter provided and further diluted using aseptic technique.
Each vial should be reconstituted with 50 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection. After reconstitution, each ml suspension in the vial contains 0.08 mg mifamurtide. The volume of reconstituted suspension corresponding to the calculated dose is extracted through the filter provided and further diluted with additional 50 ml sodium chloride 9 mg/ml (0.9 %) solution for injection according to the detailed instructions shown below.
Instructions for preparation of MEPACT for intravenous infusion
Materials provided in each package -
• MEPACT powder for suspension for infusion (vial)
• Filter for MEPACT
Materials required but not provided -
• Sodium chloride 9 mg/ml (0.9%) solution for injection, EP/USP 100 ml bag
• One single use 60 or 100 ml sterile syringe with luer lock
• Two medium (18) gauge sterile injection needles
It is recommended that the reconstitution of the liposomal suspension should be performed in a laminar flow cabinet utilising sterile gloves using aseptic technique.
The lyophilised powder should be allowed to reach a temperature between approximately 20°C – 25°C prior to reconstitution, filtering using the filter provided and dilution. This should take approximately 30 minutes.
1. The cap of the vial should be removed and the stopper cleaned using an alcohol pad.
2. The filter should be removed from the blister pack, and the cap removed from the filter spike. The spike should then be inserted into the vial septum firmly until seated. The filter luer connector cap should not be removed at this time.
3. The 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection bag, needle and syringe should be unpacked (not provided in the pack).
4. The site of the sodium chloride 9 mg/ml (0.9%) solution for injection bag where the needle is going to be inserted should be swabbed with an alcohol pad.
5. Using the needle and syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be withdrawn from the bag.
6. After removing the needle from the syringe, the syringe should be attached to the filter by opening the filter luer connector cap (Figure 1).
Figure 1
7. The sodium chloride 9 mg/ml (0.9%) solution for injection is added to the vial by slow, firm depression of the syringe plunger. The filter and syringe must not be removed from the vial.
8. The vial should be allowed to stand undisturbed for one minute to ensure thorough hydration of the dry substance.
9. The vial should then be shaken vigorously for one minute while keeping the filter and syringe attached. During this time the liposomes are formed spontaneously (Figure 2).
Figure 2
10. The desired dose may be withdrawn from the vial by inverting the vial and slowly pulling back on the syringe plunger (Figure 3). Each ml reconstituted suspension contains 0.08 mg mifamurtide. The volume of suspension to be withdrawn for dose quantities is calculated as follows:
Volume to withdraw = [12.5 x calculated dose (mg)] ml
For convenience, the following table of concordance is provided:
Dose
Volume
1.0 mg
12.5 ml
2 |
