Zypadhera ® (olanzapin)

För fullständig produktresumé för Zypadhera® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

ZypAdhera® (olanzapin pamoate): Beredning och lösningsmedelsvolym för rekonstitution

Rekonstituera olanzapinpamoat enligt beskrivningen nedan. För 210 mg-injektionsflaskan, använd 1,3 ml vätska. För 300 mg flaskan, använd 1,8 ml vätska. För 405 mg flaskan, använd 2,3 ml vätska. Koncentrationen är 150 mg/ml olanzapin.

SE_cFAQ_OLZLA307_Y2_RECONSTITUTION_AND_SOLVENT_VOLUME_FOR_RECONSTITUTION
SE_cFAQ_OLZLA307_Y2_RECONSTITUTION_AND_SOLVENT_VOLUME_FOR_RECONSTITUTION
en-GB

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

  provides the amount of solvent required to reconstitute olanzapine pamoate powder for prolonged release suspension for injection.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 (  - Fig. 1), the needle is firmly engaged into the sheath (  - 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 (  - Fig 3).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 Tap firmly to mix).1

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  ,  ).1

Unsuspended: Visible clumps1

Check for unsuspended powder and repeat tapping if needed.

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  ).1

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

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

Datum fӧr senaste ӧversyn January 24, 2021


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