Table 5.
Summary results for the laboratory simulation of preparation, reconstitution and administration times in cannulas representative of an adult patient and a paediatric patient
| NPJ5008 120 mg per vial | Dantrium® 20 mg per vial | Time difference (Dantrium® – NPJ5008 time) | |||
| Mean (min to max) preparation of water for injection (WFI)a time (n = 10) (s) | 34 (29 to 51) | 46 (38 to 62) | 12 | ||
| Mean (min to max) reconstitutionb time (n = 10) (s) | 32 (29 to 40) | 73 (55 to 86) | 41 | ||
| Mean (min to max) draw upc time (n = 10) (s) | 38 (30 to 49) | 62 (51 to 98) | 24 | ||
| Mean (min to max) total drug preparationd time (n = 10) (seconds) | 104 (88 to 140) | 181 (144 to 246) | 77 | ||
| Cannula gauge | 16 (adult) | 22 (child) | 16 (adult) | 22 (child) | |
| Mean (min to max) administratione time (n = 5) (s) | 6 (5 to 7) | 15 (14 to 18) | 12 (11 to 13) | 48 (44 to 55) | 16 gauge: 6 22 gauge: 33 |
| Average total time (n = 5)f | 1 min 53 s | 1 min 57 s | 3 min 0 s | 4 min 2 s | |
Preparation for NPJ5008 is: remove the cap from the NPJ5008 vial; remove the 20 ml syringe from its packaging; remove a sterile needle from its packaging and add to the syringe; open the bottle of WFI and withdraw 20 ml of the WFI into the syringe. Preparation for Dantrium® is: remove the cap from the Dantrium® vial; remove the 60 ml syringe from its packaging; remove a sterile needle from its packaging and add to the syringe; open the bottle of WFI and withdraw 60 ml of WFI into the syringe.
Reconstitution is: reconstitute the vial with the filled syringe; shake until the powder has been reconstituted.
Draw up is: using the same syringe and needle, collect all the solution from within the vial. Introduce 20 ml of air via the needle in order to equilibrate pressure within the vial; attach the filled syringe to the cannula via the Luer lock. For Dantrium® only draw up time also includes preparation of the filter needle spike device.
Total drug preparation time is the sum of the previous three steps (preparation, reconstitution, draw up).
Administration is: administer the solution via the cannula into a labelled glass beaker.
The average total time is not a sum of the average data per step, but represents the average total time taken for the n = 5 that used each cannula gauge type.