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PERSERIS (risperidone) for extended-release injectable suspension,(四)
2018-11-25 03:36:51 来源: 作者: 【 】 浏览:18113次 评论:0
se to inject the patient.
One Powder Syringe (Figure
) prefilled with Risperidone powder. Inspect syringe for consistency of powder color and for foreign particles.
One sterile 18-gauge, 5/8-inch safety needle.
Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Figure 1
Figure 1
2 TAP POWDER SYRINGE
See FIGURE 2
Hold the Powder Syringe upright and tap the barrel of the syringe to dislodge the packed powder.
NOTE: Powder can become packed during shipping.
Figure 2
Figure 2
3 UNCAP LIQUID AND POWDER SYRINGES
See FIGURE 3
Remove the cap from the Liquid Syringe, then remove the cap from the Powder Syringe.
Holding both syringes in your non-dominant hand can help with this step.
Figure 3
Figure 3
4 CONNECT THE SYRINGES
See FIGURE 4
Place the Liquid Syringe on top of the Powder Syringe (to prevent powder spillage) and connect the syringes by twisting approximately ¾ turn.
Do not over tighten.
Keep your fingers off the plungers during this step to avoid spillage of the medication.
Figure 4
Figure 4
5 MIX THE PRODUCT
See FIGURE 5
Failure to fully mix the medication could result in incorrect dosage.
Figure 5
Figure 5
Premixing
Transfer the contents of the Liquid Syringe into the Powder Syringe.
Gently push the Powder Syringe plunger until you feel resistance (to wet powder and avoid compacting).
Repeat this gentle back-and-forth process for 5 cycles.
Complete mixing
Continue mixing the syringes for an additional 55 cycles.
This mixing can be more vigorous than when premixing.
FIGURE 5 illustrates a correct full cycle.
When fully mixed, the product should be a cloudy suspension that is uniform in color. It can vary from white to yellow-green in color. If you see any clear areas in the mixture, continue to mix until the distribution of the color is uniform. The product is designed to deliver risperidone 90 mg or 120 mg.
6 PREPARE INJECTION SYRINGE
See FIGURE 6
Failure to aspirate the liquid from the Powder Syringe may result in incorrect dosage.
First, transfer all contents into the Liquid Syringe.
Next, perform the following actions SIMULTANEOUSLY:
maintain slight pressure on the Powder Syringe plunger and
pull back gently on the Liquid Syringe plunger while twisting the syringes apart.
Finally, attach the safety needle by twisting until finger tight.
Check that medication is uniform in color and free from foreign particles.
Figure 6
Figure 6
7 PREPARE THE ABDOMINAL INJECTION SITE
See FIGURE 7
Choose an injection site on the abdomen with adequate subcutaneous tissue that is free of skin conditions (e.g., nodules, lesions, excessive pigment). It is recommended that the patient is in the supine position.
Do not inject into an area where the skin is irritated, reddened, bruised, infected or scarred in any way.
Clean the injection site well with an alcohol pad.
To help minimize irritation, rotate injection sites following a pattern similar to the illustration (FIGURE 7).
Figure 7
Figure 7
8 REMOVE EXCESS AIR FROM SYRINGE
See FIGURE 8
Hold the syringe upright for several seconds to allow air bubbles to rise.
Remove needle cover and slowly depress the plunger to push out the excess air from the syringe.
If medication is seen at the needle tip, pull back slightly on the plunger to prevent medication
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