ZypAdhera ® (olanzapine pamoate monohydrate)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: ZypAdhera Summary of Product Characteristics (SmPC)

ZypAdhera® (olanzapine pamoate): Reconstitution and Solvent Volume for Reconstitution

Reconstitute olanzapine pamoate as described below. For the 210 mg vial use 1,3 ml solvent. For the 300 mg vial use 1,8 ml solvent. The the 405 mg vial use 2,3 ml solvent. Suspension concentration is 150 mg/ml olanzapine.

Reconstitution of Olanzapine Pamoate

Preparing materials

It is recommended that gloves are used as olanzapine pamoate may irritate the skin.1

Reconstitute olanzapine pamoate powder for prolonged release suspension for injection only with the solvent provided in the pack using standard aseptic techniques for reconstitution of parenteral products.1

Step 2: Determining solvent volume for reconstitution

Table 1 provides the amount of solvent required to reconstitute olanzapine pamoate powder for prolonged release suspension for injection.1

Table 1. Determine the amount of solvent required to reconstitute olanzapine pamoate powder for prolonged release suspension for injection.1

ZypAdhera vial strength (mg)

Volume of solvent to add (ml)

210

1.3

300

1.8

405

2.3

It is important to note that there is more solvent in the vial than is needed to reconstitute.

It is important to note that there is more solvent in the vial than is needed to reconstitute.1

Suspension concentration is 150 mg/ml olanzapine.1

STEP 3: reconstituting ZypAdhera

1. Loosen the powder by lightly tapping the vial.1

2. Open the pre-packaged Hypodermic syringe and needle with needle protection device. Peel blister pouch and remove device. Attach a syringe (if not already attached) to the Luer connection of the device with an easy twisting motion. Seat the needle firmly on the device with a push and a clockwise twist, then pull the needle cap straight away from the needle. Failure to follow these instructions may result in a needlestick injury.1

3. Withdraw the pre-determined solvent volume (Step 2) into the syringe.1

4. Inject the solvent volume into the powder vial.1

5. Withdraw air to equalize the pressure in the vial.1

6. Remove the needle, holding the vial upright to prevent any loss of solvent.1

7. Engage the needle safety device. Press the needle into the sheath using a one-handed technique. Perform a one-handed technique by gently pressing the sheath against a flat surface. As the sheath is pressed (Figure 1 - Fig. 1), the needle is firmly engaged into the sheath (Figure 1 - Fig. 2).1

8. Visually confirm that the needle is fully engaged into the needle protection sheath. Only remove the device with the engaged needle from the syringe when required by a specific medical procedure. Remove by grasping the Luer hub of the needle protection device with thumb and forefinger, keeping the free fingers clear of the end of the device containing the needle point (Figure 1 - Fig 3).1

Figure 1. Instructions for Needle Safety Device1

9. Tap the vial firmly and repeatedly on a hard surface until no powder is visible. Protect the surface to cushion impact (see Figure 2).1

Figure 2. Tap firmly to mix

10. Visually check the vial for clumps. Unsuspended powder appears as yellow, dry clumps clinging to the vial. Additional tapping may be required if clumps remain (see Figure 3, Figure 4).1

Figure 3. Unsuspended: Visible clumps1

Check for unsuspended powder and repeat tapping if needed.

Figure 4. Suspended: No clumps1

Check for unsuspended powder and repeat tapping if needed.

11. Shake the vial vigorously until the suspension appears smooth and is consistent in colour and texture. The suspended product will be yellow and opaque (see Figure 5).1

Figure 5. Vigorously shake vial1

If foam forms, let vial stand to allow foam to dissipate. If the product is not used immediately, it should be shaken vigorously to re-suspend. Reconstituted ZypAdhera remains stable for up to 24 hours in the vial.1

References

1. ZypAdhera [summary of product characteristics] Eli Lilly Netherland B.V., The Netherlands.

Date of Last Review: January 24, 2018

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