Administration

Step by step administration of Mepact

  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 Using the needle and syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be withdrawn from the bag.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).
  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).
  1. The desired dose may be withdrawn from the vial by inverting the vial and slowly pulling back on the syringe plunger (Figure 3).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 The volume of suspension to be withdrawn for dose quantities is calculated as follows: Volume to withdraw = [12.5 x calculated dose (mg)] ml.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 table of concordance is provided below:
    Dose1.0 mg2.0 mg3.0 mg4.0mg
    Volume12.5 ml25 ml37.5 ml50 ml
  2. The syringe should then be removed from the filter and a new needle placed on the suspension-filled syringe. The bag injection site should be wiped with an alcohol pad and the suspension in the syringe should be injected into the original bag containing the remaining 50 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (Figure 4).
  3. The bag should be gently swirled to mix the solution.
  4. Patient identification, time and date should be added to the label on the bag containing the reconstituted, filtered and diluted liposomal suspension.
  5. Chemical and physical in-use stability has been demonstrated for 6 hours at room temperature (between approximately 20°C–25°C).
  6. From a microbiological point of view, the product should be used immediately. 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 6 hours at room temperature.
  7. The liposomal suspension is infused intravenously over about one hour.

Figure 1

Figure 2

Figure 3

Figure 4

Storing Mepact

Unopened vial

Store in a refrigerator (2°C–8°C). Do not freeze. Keep the vial in outer carton in order to protect from light

Reconstituted suspension

Once reconstituted in sodium chloride 9 mg/ml (0.9%) solution, store at room temperature (approximately 20°C–25°C) and use within 6 hours