MONONINE is intended for intravenous administration only. It should be reconstituted with the volume of Sterile Water for Injection, USP supplied with the lot, and administered within three hours of reconstitution. Do not refrigerate after reconstitution. After administration, any unused solution and the administration equipment should be discarded.

As a general rule, 1 IU of Factor IX activity per kg can be expected to increase the circulating level of Factor IX by 1% [IU/dL] of normal. The following formula provides a guide to dosage calculations:

The amount of MONONINE to be infused, as well as the frequency of infusions, will vary with each patient and with the clinical situation.11,12

As a general rule, the level of Factor IX required for treatment of different conditions is as follows:

Recovery of the loading dose varies from patient to patient. Doses administered should be titrated to the patient's response. MONONINE administered in doses of ≥75 IU/kg were well tolerated (see CLINICAL PHARMACOLOGY).

In the presence of an inhibitor to Factor IX, higher doses of MONONINE might be necessary to overcome the inhibitor (see PRECAUTIONS). No data on the treatment of patients with inhibitors to Factor IX with MONONINE are available.

For information on rate of administration, see Rate of Administration, below.

Reconstitution

Follow the steps provided below for the preparation and reconstitution of MONONINE:

• Check the expiration date on the vial label and carton. Do not use MONONINE after the expiration date.
• Check packaging for damage. Do not use MONONINE if the packaging is damaged or appears to be tampered with.
• Reconstitute MONONINE using aseptic technique to maintain product sterility.

1. Ensure that the MONONINE vial and Sterile Water for Injection vial are at room temperature.
2. Remove the plastic flip-top cap from the Sterile Water for Injection vial.
3. Wipe the rubber stopper of the Sterile Water for Injection vial with antiseptic solution and allow it to dry.
4. Open the Mix2Vial® filter transfer set by peeling off the lid (Fig. 1). Do not remove the transfer set from the blister package.	Fig. 1
5. Place the Sterile Water for Injection vial on an even, clean surface and hold the vial tight. Take the transfer set together with the blister package and vertically pierce the Sterile Water for Injection vial with the blue tip of the transfer set (Fig. 2).	Fig. 2
6. Carefully remove the blister package from the transfer set by holding at the rim, and pulling vertically upwards. Make sure that you only pull away the blister package and not the transfer set (Fig. 3).	Fig. 3
7. Remove the plastic flip-top cap from the MONONINE vial.
8. Wipe the rubber stopper of the MONONINE vial with antiseptic solution and allow it to dry.
9. Place the MONONINE vial on an even and firm surface. Invert the Sterile Water for Injection vial with the transfer set attached and vertically pierce the MONONINE vial with the clear tip of the transfer set (Fig. 4). The Sterile Water for Injection will automatically flow into the MONONINE vial. NOTE: Ensure all water has transferred into the MONONINE vial.	Fig. 4
10. With one hand, grasp the MONONINE side of the transfer set and with the other hand grasp the Sterile Water for Injection side of the transfer set. Carefully unscrew the set counterclockwise into two pieces (Fig. 5). Discard the Sterile Water for Injection vial with the blue end of the transfer set attached.	Fig. 5
11. Gently swirl the MONONINE vial until the powder is completely dissolved (Fig. 6). DO NOT SHAKE.	Fig. 6
12a. Draw air into an empty, sterile syringe. 12b. While the MONONINE vial is upright, connect the syringe to the transfer set Luer Lock fitting by screwing clockwise. Inject air into the MONONINE vial (Fig. 7).	Fig. 7
13. While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly (Fig. 8).	Fig. 8
14. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the clear transfer set adapter from the syringe by unscrewing counterclockwise (Fig. 9).	Fig. 9