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RADIESSE injectable implant is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
DOSAGE AND ADMINISTRATION
Directions For Use
The following is required for the percutaneous injection procedure:
- RADIESSE injectable implant syringe(s)
- 25 gauge OD - 27 gauge ID needle(s) with Luer lock fittings
- Prepare patient for percutaneous injection using standard methods. The treatment injection site should be marked and prepared with a suitable antiseptic. Local or topical anesthesia at the injection site should be used at the discretion of the physician.
- Prepare the syringes of RADIESSE injectable implant and the injection needle(s) before the percutaneous injection. A new injection needle may be used for each syringe, or the same injection needle may be connected to each new syringe.
- Remove foil pouch from the carton. Open the foil pouch by tearing at the notches (marked 1 and 2), and remove the syringe from the foil pouch. There is a small amount of moisture normally present inside the foil pouch for sterilization purposes; this is not an indication of a defective product.
- Peel or twist apart the needle packaging to expose the hub. For use of needles other than the needle(s) provided with this package, follow the directions provided with the needle(s).
- Remove the Luer syringe cap from the distal end of the syringe prior to attaching the needle. The syringe of RADIESSE injectable implant can then be twisted onto the Luer lock fitting of the needle taking care not to contaminate the needle. Discard needle package. The needle must be tightened securely to the syringe and primed with RADIESSE injectable implant. If excess implant is on the surface of the Luer lock fittings, it will need to be wiped clean with sterile gauze. Slowly push the syringe plunger until RADIESSE injectable implant extrudes from the end of the needle. If leakage is noted at the Luer fitting, it may be necessary to tighten the needle, or to remove the needle and clean the surfaces of the Luer fitting or, in extreme cases, replace both the syringe and the needle.
- Locate the initial site for the implant. Scar tissue and cartilage may be difficult or impossible to treat. Avoid if possible, passing through these tissue types when advancing the injection needle.
- The amount injected will vary depending on the site and extent of the restoration or augmentation desired. RADIESSE injectable implant should be injected subdermally.
- Use a 1:1 correction factor. No overcorrection is needed.
- Insert needle with bevel down at approximately a 30° angle to the skin. Needle should slide under the dermis to the point you wish to begin the injection. This should be easily palpable with the non-dominant hand.
- If significant resistance is encountered when pushing the plunger, the injection needle may be moved slightly to allow easier placement of the material or it may be necessary to change the injection needle. One needle jam occurred in the nasolabial fold clinical study. Needle jams are more likely with use of needles smaller than 27gauge ID.
- Advance the needle into the subdermis to the starting location. Carefully push the plunger of the RADIESSE injectable implant syringe to start the injection and slowly inject the implant material in linear threads while withdrawing the needle. Continue placing additional lines of material until the desired level of correction is achieved.
- Apply slow continuous even pressure to the syringe plunger to inject the implant as you withdraw the needle. The implant material should be completely surrounded by soft tissue without leaving globular deposits. The injected area may be massaged as needed to achieve even distribution of the implant.
- Use once and discard in accordance with local safety standards.
Technique for Mixing RADIESSE injectable implant and 2% Lidocaine HCl
CAUTION: Do not use the RADIESSE injectable implant and 2% lidocaine mixture later than 2 hours after mixing.
CAUTION: The assembled components are intended for one-time use only.
Within the clinical study, the following components were used:
- Sterile 27 gauge, 0.5” regular-wall needle with Luer lock connector (not supplied by Merz Aesthetics, Inc.).
- 3.0cc sterile polypropylene luer-lock syringe (BD 309585)
- 0.2cc of Hospira, Inc. (NDC 0409-4277-02) 2% lidocaine HCl for injection, USP solution (not supplied by Merz Aesthetics, Inc.)
- Sterile Female-to-female luer lock connector (Braun FDC1000 or Baxa 13901)
- 1.3cc syringe of RADIESSE injectable implant
The 3.0cc sterile polypropylene mixing syringe (BD 309585) and the female-to-female luer lock connector (Baxa 13901) are separately available in the Merz Aesthetics Accessory Kit. Neither the lidocaine nor the sterile 27 gauge, 0.5“ needle are supplied by Merz Aesthetics, Inc.
Component Assembly and Mixing Instructions
1. Assemble the components and perform the mixing using sterile technique (see Figure 1).
Figure 1: Left to right: Female-to-female luer lock
connector, RADIESSE syringe, 3.0cc mixing syringe, sterile 27 gauge, 0.5”
2. Draw the lidocaine into a 3.0cc sterile polypropylene mixing syringe fitted with a sterile 27 gauge, 0.5” needle.
3. Tap the mixing syringe, containing lidocaine and depress its push rod to remove all excess air.
4. Remove the sterile 27gauge, 0.5” needle.
5. Firmly connect the mixing syringe to the RADIESSE syringe using the female-to-female luer lock connector (see Figures 2 and 3).
6. Mix the lidocaine and RADIESSE injectable implant by alternately depressing the plungers, first on the mixing syringe and then on the RADIESSE syringe for ten mixing strokes (each mixing stroke is one complete compression of the mixing syringe plunger followed by one complete compression of the RADIESSE syringe plunger). Plungers are compressed firmly and quickly, at about two compressions per second.
7. After mixing, remove the mixing syringe and the female-to-female luer lock connector and discard.
8. Fit the syringe containing the lidocaine and RADIESSE mixture with an injection needle.
9. Proceed with the injection of the RADIESSE injectable implant.
The clinical study was conducted by mixing 0.2cc of 2% lidocaine with 1.3cc of RADIESSE injectable implant in the 3.0cc BD syringe. The table below provides the ratio of 2% lidocaine to be mixed with the various syringe volumes of RADIESSE injectable implant. These ratios result in the same concentration of 2% lidocaine (w/v%) in RADIESSE injectable implant that was mixed in the clinical study after accounting for the dead space in the RADIESSE and 3.0cc BD mixing syringes (see Table 34).
Table 34: LIDOCAINE CONCENTRATION
|RADIESSE® (cc)||2% Lidocaine (cc)||Resulting Lidocaine Concentration (w/v%)|
|0.3||0.02||0.30% - 0.33%|
|0.8||0.11||0.31% - 0.32%|
|1.3||0.20||0.31% - 0.32%|
|1.5||0.26||0.31% - 0.32%|
|3.0||0.45||0.32% - 0.34%|
RADIESSE injectable implant should be stored at a controlled room temperature between 15° C and 32° C (59° F and 90° F). The expiration date, when stored in these temperatures, is two years from date of manufacture. Do not use if the expiration date has been exceeded.
Used and partially used syringes and injection needles could be biohazardous and should be handled and disposed of in accordance with facility medical practices and local, state or federal regulations.
Merz Aesthetics, Inc. warrants that reasonable care has been exercised in the design and manufacture of this product.
THIS WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES NOT EXPRESSLY SET FORTH HEREIN, WHETHER EXPRESSED OR IMPLIED BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ITS PARTICULAR PURPOSE.
Handling and storage of this product, as well as factors relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond Merz Aesthetics's control directly affect the product and the results obtained from its use. Merz Aesthetics's obligation under this warranty is limited to the replacement of this product and Merz Aesthetics shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly, arising from the use of this product. Merz Aesthetics neither assumes, nor authorizes any person to assume for Merz Aesthetics, any other or additional liability or responsibility in connection with this product.
Manufactured by: Merz Aesthetics, Inc., 4133 Courtney Road, Suite #10, Franksville, WI 53126 U.S.A. Fax: 262-835-3330This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/8/2013
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