Restylane Silk is indicated for submucosal implantation
for lip augmentation and dermal implantation for correction of perioral rhytids
in patients over the age of 21.
DOSAGE AND ADMINISTRATION
Directions for Assembly
For safe use of Restylane Silk, it is important that the
needle is properly assembled.
Assembly Of 30 G Needle To Syringe
Use the thumb and forefinger to hold firmly around both
the glass syringe barrel and the Luer-Lok adapter. Grasp the needle shield with
the other hand. To facilitate proper assembly, both push and rotate firmly.
Prior to treatment, the patient should avoid taking
aspirin, nonsteroidal anti-inflammatory medications, St. John's Wort, or high
doses of Vitamin E supplements. These agents may increase bruising and bleeding
at the injection site.
1. It is necessary to counsel the patient and discuss the
appropriate indication, risks, benefits and expected responses to the Restylane
Silk treatment. Advise the patient of the necessary precautions before
commencing the procedure.
2. Assess the patient's need for appropriate anesthetic
treatment for managing comfort, i.e., topical anesthetic, local or nerve block.
3. The patient's face should be washed with soap and
water and dried with a clean towel. Cleanse the area to be treated with alcohol
or another suitable antiseptic solution.
4. Sterile gloves are recommended while injecting Restylane
5. Before injecting, press rod carefully until a small
droplet is visible at the tip of the needle.
6. Restylane Silk is administered using a thin gauge
needle (30 G x ½”). The needle is inserted at an approximate angle of 30°
parallel to the length of the wrinkle, fold, or lip. For rhytids, Restylane
Silk should be injected into the mid-to-deep dermis. Restylane Silk should be
injected into the submucosal layer for lip augmentation, care should be taken
to avoid intramuscular injection. If Restylane Silk is injected too superficially
this may result in visible lumps and/or bluish discoloration.
7. Inject Restylane Silk applying even pressure on the
plunger rod. It is important that the injection is stopped just before the
needle is pulled out of the skin to prevent material from leaking out or ending
up too superficially in the skin.
8. Only correct to 100% of the desired volume effect. Do
not overcorrect. With cutaneous deformities the best results are obtained if
the defect can be manually stretched to the point where it is eliminated. The
degree and duration of the correction depend on the character of the defect
treated, the tissue stress at the implant site, the depth of the implant in the
tissue and the injection technique.
9. Typical usage for each treatment session is specific
to the site as well amount of augmentation or rhytids correction desired. Based
on U.S. clinical studies, the maximum recommended dose per treatment is 1.5 mL
per lip per treatment or 1.0 mL for perioral rhytid correction.
1. Restylane Silk can be injected by a number of
different techniques that depend on the treating physician's experience and
preference, and patient characteristics.
2. Serial puncture (F) involves multiple, closely spaced
injections along wrinkles or folds. Although serial puncture allows precise
placement of the filler, it produces multiple puncture wounds that may be
undesirable to some patients.
3. Linear threading (includes retrograde and antegrade)
(G) is accomplished by fully inserting the needle into the middle of the
wrinkle or fold and injecting the filler along the track as a “thread.”
Although threading is most commonly practiced after the needle has been fully
inserted and is being withdrawn, it can also be performed while advancing the
needle (“push-ahead” technique). To enhance the vermillion of the lip, the
retrograde linear threading technique is the most advisable.
4. Serial threading is a technique that utilizes elements
of both approaches.
Note! The correct injection technique is crucial for
the final result of the treatment.
F. Serial Puncture
G. Linear Threading (includes retrograde and
5. Dissection of the sub-epidermal plane with lateral
movement of the needle, rapid flows ( > 0.3 mL/min), rapid injection or high
volumes may result in an increase in short-term episodes of bruising, swelling,
redness, pain, or tenderness at the injection site.
6. When the injection is completed, the treated site
should be gently massaged so that it conforms to the contour of the surrounding
tissues. If an overcorrection has occurred, massage the area firmly between
your fingers or against an underlying area to obtain optimal results.
7. If so called “blanching” is observed, i.e., the
overlying skin turns a whitish color, the injection should be stopped
immediately and the area massaged until it returns to a normal color.
8. If the wrinkles or lips need further treatment, the
same procedure should be repeated until a satisfactory result is obtained.
Additional treatment with Restylane Silk may be necessary to achieve the
9. If the treated area is swollen directly after the
injection, an ice pack can be applied on the site for a short period. Ice
should be used with caution if the area is still numb from anesthetic to avoid
10. Patients may have mild to moderate injection site
reactions, which typically resolve in less than 18 days in the lip.
Follow national, local or institutional guidelines for
use and disposal of medical sharp devices. Obtain prompt medical attention if
- To help avoid needle breakage, do not attempt to
straighten a bent needle. Discard it and complete the procedure with a
- Do not reshield used needles. Recapping by hand is a
hazardous practice and should be avoided.
- Discard unshielded needles in approved sharps collectors.
- Restylane Silk is provided with a needle that does not
contain engineered injury protection. Administration of Restylane Silk requires
direct visualization and complete and gradual insertion of the needle making
engineered protections infeasible. Care should be taken to avoid sharps
exposure by proper environmental controls.
Restylane Silk is supplied in a disposable glass syringe
with a Luer-Lok® fitting.
Restylane Silk is co-packed with sterilized needle(s) 30
G x ½” as indicated on the carton.
A patient record label is a part of the syringe label.
Remove it by pulling the flap marked with three small arrows. This label is to
be attached to patient records to ensure traceability of the product.
The contents of the syringe are sterile.
The volume in each syringe and needle gauge is as stated
on the syringe label and on the carton.
Shelf Life And Storage
Restylane Silk must be used prior to the expiration date
printed on the package.
Store at a temperature of up to 25° C (77° F). Do not
freeze. Protect from sunlight. Refrigeration is not required.
Do not resterilize Restylane Silk as this may damage or
alter the product.
Do not use if the package is damaged. Immediately return
the damaged product to Galderma Laboratories, L.P.
Galderma Laboratories, L.P. and its distributor, McKesson
Specialty, are your only credits for FDA-approved Restylane Silk. Purchasing
from any other agent is illegal. To order call 1-855-425-8722
Manufactured for: Galderma Laboratories, L.P., 14501 N.
Freeway, Fort Worth, TX 76177 USA, Phone: 1-855-425-8722. Manufactured by: Q-Med
AB, Seminariegatan 21, SE-752 28 Uppsala, Sweden. Revised: Sep 2014.