Zypadhera ® (olanzapin)

För fullständig produktresumé för Zypadhera® se FASS.

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ZypAdhera® (olanzapinpamoat): Undvika tilltäppning av kanyl och andra problem

Sätt alltid på en ny säkerhetskanyl på sprutan före injektion. Ytterligare information om hantering av problem med kanyler återfinns nedan.

Detailed Information

The carton contains the following needles for reconstitution and administration:

  • one Hypodermic 3 ml syringe with pre-attached 19-gauge, 38 mm safety needle,

  • one 19-gauge, 38 mm Hypodermic safety needle and

  • two 19-gauge, 50 mm Hypodermic safety needles.1

The needles are provided for safety and convenience purposes.2

Needle clogs during administration of olanzapine pamoate

Always change the needle to a fresh needle immediately before administration of the dose.2

If there is resistance encountered during the injection, attempt to finish the injection by slightly repositioning the needle.2

If the needle clogs and the injection cannot be finished, please follow these steps.

  • First try pulling back on the plunger to clear the needle and attempt to finish the injection.2

  • If the needle is still clogged, remove the needle from the patient. Replace the needle with a fresh needle and attempt to deliver the remainder of the dose.2

  • If the injection still does not complete, it is considered a complete dose; do not attempt to make up a fresh vial and calculate the difference.2

Important information about bent or damaged needles

Bent or damaged needles can result in breakage or damage to the tissue or accidental needle puncture.2

If the needle is bent or damaged, do not attempt to straighten the needle or engage the Needle-Pro device. The Needle-Pro device may not properly contain a bent needle and/or the needle could puncture the needle protection device, which may result in a needle stick with a contaminated needle.2

Mishandling of the needle protection device may cause needles, especially short or small-gauge needles, to bend, whereby they protrude from the needle protector sheath, which may result in a contaminated needle stick.2

Avoidance of Stopper Fragmentation During Reconstitution

The primary contributor of particulate matter in vial presentations originates from the rubber closure.3 Therefore, particles observed after reconstitution might originate from puncturing the stopper with the needle. Many elements can influence the production of stopper fragments during reconstitution (see Table 1).4

Table 1. Potential Causes of Stopper Fragmentation During Reconstitution of Olanzapine LAI4

Potential Cause

Explanation

Needle type

Blunt needle tips have a much greater tendency to produce fragments than sharp tips.

Needle gauge

Needles larger than 21-gauge tend to promote fragmentation.

Force of puncture

Lower needle insertion forces reduce the tendency to produce fragments.

Angle of puncture

Needle insertion at a 45° angle to the plane of the stopper reduces the likelihood of fragments.

Incorrect use

Using a spike on a stopper design that was not intended to receive a spike will produce fragments.


To avoid stopper fragmentation during reconstitution of olanzapine pamoate,

  • insert the needle at a 45° angle, instead of vertically 90° angle to the plane of the stopper

  • apply a steady force when puncturing the membrane but avoid a rapid, forceful puncture or a twisting motion, and

  • carefully inspect the needle prior to use for any damage to the tip including blunting.2

References

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

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3. Dempsey G, Webber GS. Hazards of particle injection. Pharm J. 1983;231:63-64.

4. Gallagher P. Causes of coring and fragmentation in the field . West Pharma. Available at: https://www.westpharma.com/blog/2014/June/Causes-of-Coring-and-Fragmentation-in-the-Field. Published June 23, 2014. Accessed January 29, 2018. https://www.westpharma.com/blog/2014/June/Causes-of-Coring-and-Fragmentation-in-the-Field

Glossary

LAI = Long Acting Injection

Datum fӧr senaste ӧversyn 2018 M01 24

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